WO2014064607A1 - Apparatus & systems for tissue dissection & modification - Google Patents

Apparatus & systems for tissue dissection & modification Download PDF

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Publication number
WO2014064607A1
WO2014064607A1 PCT/IB2013/059532 IB2013059532W WO2014064607A1 WO 2014064607 A1 WO2014064607 A1 WO 2014064607A1 IB 2013059532 W IB2013059532 W IB 2013059532W WO 2014064607 A1 WO2014064607 A1 WO 2014064607A1
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WO
WIPO (PCT)
Prior art keywords
protrusions
tip
tissue
energy
shaft
Prior art date
Application number
PCT/IB2013/059532
Other languages
French (fr)
Inventor
Paul Weber
Original Assignee
Paul Weber
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US13/659,873 external-priority patent/US20130338652A1/en
Priority claimed from US13/759,969 external-priority patent/US20140188128A1/en
Priority claimed from US13/802,731 external-priority patent/US20140188095A1/en
Application filed by Paul Weber filed Critical Paul Weber
Publication of WO2014064607A1 publication Critical patent/WO2014064607A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30Surgical robots
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3209Incision instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/1815Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/203Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser applying laser energy to the outside of the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90Identification means for patients or instruments, e.g. tags
    • A61B90/98Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B2017/320044Blunt dissectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00589Coagulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00601Cutting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00791Temperature
    • A61B2018/00809Temperature measured thermochromatically

Definitions

  • FIG. 1 a is a perspective view of an embodiment of a tissue dissector and modifier with an energy window on the upper side of the device.
  • FIG. 1 b is a side elevation view of the embodiment previously depicted in FIG. 1a.
  • FIG. 1 c is a front elevation view of the embodiment previously depicted in FIG. 1a.
  • FIG. 1 d is a front elevation view illustrating the protrusions and lysing segment of an alternative embodiment of a tissue dissector and modifier wherein the lysing segment connecting the two protrusions is centered substantially midway between the upper and lower portions of the protrusions.
  • FIG. 1 e is a front elevation view illustrating the protrusions and lysing segment of an alternative embodiment of a tissue dissector and modifier, wherein the lysing segment connecting the two protrusions is positioned above the midline between the upper and lower portions of the protrusions.
  • FIG. 1f is a front elevation view illustrating the protrusions and lysing segment of an alternative embodiment of a tissue dissector and modifier, wherein the lysing segment connecting the two protrusions is positioned below the midline between the upper and lower portions of the protrusions.
  • FIG. 1g is a cross-sectional view of an embodiment of a TDM illustrating some examples of some of the canals that may be used with the device.
  • FIG. 2a is a perspective view of an embodiment of a tissue dissector and modifier with a thermochromic-based energy window on the upper side of the device.
  • FIG. 2b is a side elevation view of the embodiment previously depicted in FIG. 2a.
  • FIG. 2c is a front elevation view of some thermochromic-based energy window components of an embodiment previously depicted in FIG. 2a.
  • FIG. 3a is a perspective view of an embodiment of a tissue dissector and modifier with a target-tissue-impedance-matched-microwave-based energy window on the upper side of the device.
  • FIG. 3b is a side elevation view of the embodiment previously depicted in FIG. 3a.
  • FIG. 3c is a front elevation view of some target-tissue-impedance-matched-microwave- based energy window components of an embodiment previously depicted in FIG. 3a.
  • FIG. 4 is a wiring diagram of a bipolar embodiment of the TDM.
  • FIG. 5a is an upper plan view illustrating the protrusions and lysing elements of an embodiment of a tissue dissector and modifier, wherein some of the protrusions and lysing elements are oriented in a non-axial direction and the non-axial protrusions do not extend beyond the width of the distal shaft.
  • FIG. 5b is an upper plan view illustrating the protrusions and lysing elements of an alternative embodiment of a tissue dissector and modifier, wherein some of the protrusions and lysing elements are oriented in a non-axial direction and some of the non-axial protrusions extend beyond the width of the distal shaft.
  • FIG. 5c is a lower plan view of the embodiment of FIG. 5a illustrating the protrusions and lysing elements of a tissue dissector and modifier, wherein some of the protrusions and lysing elements are oriented in a non-axial direction and the non-axial protrusions do not extend beyond the width of the distal shaft.
  • FIG. 5d is a lower plan view of the embodiment of FIG. 5b illustrating the protrusions and lysing elements of a tissue dissector and modifier, wherein some of the protrusions and lysing elements are oriented in a non-axial direction and some of the non-axial protrusions extend beyond the width of the distal shaft.
  • FIG. 6 depicts an embodiment comprising a modular, removable tip and a rigid shaft.
  • FIG. 7a is a side view of a robotic surgery system comprising a TDM.
  • FIG. 7b depicts an alternative robotic arm that may be used with the system of FIG. 7a.
  • FIG. 8 depicts an embodiment comprising a modular, removable tip and a flexible shaft.
  • dissection may indicate the separation of tissues or of one tissue plane from another (ref: Free Online Medical Dictionary). Some also consider dissection to comprise separation of a single tissue into portions. Much of the bodies of animals and humans are formed from embryonic fusion planes. Many of the organs of the human body are categorized from the embryonic fusion planes from whence they came. The interfaces between organs may often be referred to as 'tissue planes.' Such planes may be considered substantially planar depending upon the size of a comparative planar living or inanimate object (such as a surgical instrument).
  • a lobe of a human liver has a radius of curvature of about 5cm; however, compared to a surgical instrument of about 1cm in width capable of separating tissue in a plane, the curvilinear plane comprising the liver lobe may be 'substantially' planar and thus amenable to a tool capable of separating tissues in a 'substantially planar' fashion.
  • Various vessels or ducts may also traverse within a given organ thus providing for areas of 'substantially planar' boundaries even within a given organ.
  • the TDM may divide what may appear to be isodense tissues.
  • An example of separating isodense tissues may be separating one lobe of liver from another lobe within that liver. Depending on the density of a certain tumor, separation from the involved organ may also be an isodense dissection/separation.
  • the TDM may perform the 75 functions of sharp dissection, blunt dissection and electrosurgical cutting and/or coagulation without a surgeon having to switch instruments.
  • Sharp dissection has been referred to by some as separation of tissues by means of the sharp edge of a knife or scalpel or with the inner sharp edge of scissors.
  • Blunt dissection has been defined by Webster as surgical separation of tissue layers by means of an instrument without a cutting edge or by the fingers. The term
  • Loose connective tissue is the most common type of connective tissue in vertebrates. Loose connective tissue holds organs in place and attaches epithelial tissue to other underlying tissues; it also surrounds the blood vessels and nerves. Fibroblast cells are widely dispersed in this tissue; they are irregular
  • Collagenous fibers collagenous fibers are made of collagen and consist of bundles of
  • Elastic fibers elastic fibers are made of elastin and are "stretchable.”
  • Reticular fibers reticular fibers consist of one or more types of very thin collagen fibers; these fibers join connective tissues to other tissues.
  • Areolar tissue (Latin for a little open space) is a common type of connective tissue, and may also be referred to as “loose connective tissue”. It is strong enough to bind different tissue types
  • Areolar tissue fibers run in random directions and are mostly collagenous, but elastic and reticular fibers are also present. Areolar tissue is highly variable in appearance. In many serous membranes, it appears as a loose arrangement of collagenous and elastic fibers, scattered cells of various 100 types, abundant ground substance, and numerous blood vessels. In the skin and mucous
  • areolar tissue may be more compact and sometimes difficult to distinguish from dense irregular connective tissue.
  • Areolar tissue is the most widely distributed connective tissue type in vertebrates. It is sometimes equated with "loose connective tissue”. In other cases, "loose connective tissue" is considered a parent category that includes mucous
  • tissue connective tissue, reticular connective tissue and adipose tissue. It may be found in tissue
  • the term 'minimally invasive surgery' has been used to describe a procedure (surgical or otherwise) that is less invasive than open surgery used for the same purpose.
  • Some minimally invasive procedures typically involve use of laparoscopic devices and remote-control manipulation of instruments with indirect observation of the surgical field through an endoscope or similar device, and are carried out through the skin or through a body cavity or anatomical 115 opening. This may result in shorter hospital stays, or allow outpatient treatment (reference:
  • modifying' in this context may refer to or may encompass application of energy to tissue using one or more lysing elements as discussed herein.
  • TDM Tissue Dissecting and Modifying Wand
  • Tissues or organs or tumors treated with the TDM may also undergo post traumatic collagen deposition or scarring. Thermal damage to collagen is likely brought about by
  • Some tissues of the body are of varying sensitivity to electrosurgical energy. Modulation
  • liver tumors or tissues may allow heating to temperature ranges higher than temperatures that typically be involved in facial rejuvenation procedures
  • liver tumors or tissues may be operated upon by heating the tissue to a temperature range of about 72-85° C.
  • the TDM may dissect tissue planes of dissimilar density as well as isodense tissue planes.
  • the TDM may also dissect different types of tissues from one another as well as dissect within an organ. It is possible that the cutting segments alone may traumatize or lyse portions of tissues sufficiently to carry out a given surgical method or procedure. It is also possible that when electrically energized with electro-cutting current, the TDM may possess a plasma field that may traumatize certain tumor cells in a potentially lethal fashion.
  • the TDM may be 150 "energized" by various forms of energy in its top side energy window, as described in greater detail below. Such energy absorptions may result in the formation of heat which may, in turn, damage tumor or other tissue cells themselves, and/or their surrounding environment in order to achieve a desired effect of a surgical method or procedure.
  • energy may be delivered from one or more energy windows so as to 155 heat tissue to a temperature of about 72°C to about 80°C.
  • Various methods may therefore be implemented in which the amount of energy and/or the delivery time may be adjusted so as to heat the tissue to within a desired temperature range.
  • Temperature sensors may therefore be incorporated on or near the energy windows to allow a surgeon to heat the tissue to a desired temperature or within a desired temperature range.
  • the sensor may be 160 configured to provide an average temperature over a particular period of time and or over a particular range of distances within the tissue.
  • Systems consistent with the disclosure provided herein may be configured to prevent or to shut down or otherwise limit energy transfer if a particular tissue temperature were beyond a threshold or alternatively if an average temperature threshold is reached.
  • Temperature sensors that may be useful in connection with embodiments disclosed herein include, but are not limited to, resistance temperature sensors, such as carbon resistors, film thermometers, wire-wound thermometers, or coil elements. Some embodiments may comprise thermocouples, pyrometers, or non-contact temperature sensors, such as total radiation or photoelectric sensors. In some embodiments, one or more temperature sensors may be
  • a processor and/or a monitor coupled with a processor and/or a monitor to allow a surgeon to better visualize or otherwise control the delivery of energy to selected areas of target tissue.
  • a processor and/or a monitor to allow a surgeon to better visualize or otherwise control the delivery of energy to selected areas of target tissue.
  • embodiments may be configured such that a surgeon can visualize the temperature of tissue positioned adjacent to one or more locations along the TDM to ensure that such temperatures are within a desired temperature range. Some embodiments may alternatively, or additionally,
  • the system may be configured such that one or more temperature sensors are coupled with a processor in a feedback loop such that energy delivery may be automatically adjusted by the system in response to temperature data. For example, when temperatures exceed a particular threshold, such as somewhere between about 65° C and about 90° C, the system may be configured to shut down or otherwise limit further energy delivery. In some such embodiments, the threshold
  • 180 may be between about 68° C and about 75° C.
  • Some embodiments may comprise a feedback means, such as a visual, audible, or tactile feedback means, to provide information to a user to avoid excess energy delivery to tissues.
  • the feedback means may be configured to notify the surgeon when the temperature has reached a particular threshold.
  • the feedback means may be configured to notify the surgeon when the temperature has reached a particular threshold.
  • 185 may be configured to notify the surgeon when the TDM has been positioned in a particular location within the target region for a particular time period.
  • visual feedback means include LED lights, LASERS, visual light source, display screen, etc.
  • audible feedback means include speakers, alarms, audible vibration, etc.
  • tactile feedback means include vibration, minimal electrical shock, heat, etc.
  • the feedback means may be
  • the TDM may be configured to deliver a first noise and at a second threshold the TDM may be configured to deliver a second noise.
  • the second noise may be louder than the first noise to indicate a greater urgency for changing the energy delivery and/or moving the TDM from its current location within a patient's body.
  • an antenna(s) may be
  • a camera or fiberoptic may be used to control the shaft or tip of the TDM.
  • a camera or fiberoptic may be used to control the shaft or tip of the TDM.
  • the TDM may be used to induce post-surgical collagen deposition and/or an inflammatory tissue reaction in the target zone.
  • using the TDM are done by delivering energies of about 20 J/cm 2 .
  • a higher energy delivery may be employed than 20 J/cm 2 .
  • some implementations for increasing post-surgical collagen deposition may be performed by delivering energy at a level 20% or more than 20 J/cm 2 .
  • Tissue Dissector is intended to encompass any of the devices for dissecting tissue disclosed herein including, but not limited to, Tissue Dissecting and Modifying Wands (TDM) comprising lysing elements, tissue dissecting wands lacking lysing elements, and tissue dissecting wands either comprising or lacking energy windows.
  • TDM Tissue Dissecting and Modifying Wands
  • the lysing elements may comprise lysing segments.
  • FIG. 1 a is a perspective view of an embodiment of a TDM with an electrosurgically energized energy window 107 on the upper side of the device. It should be noted that the term "energy window" is intended to encompass what is referred to as a planar-tissue-altering-
  • the "energy window” may comprise a variety of other energy emitting devices, including radiofrequency, intense pulsed light, LASER, thermal, microwave and ultrasound. It should also be understood that the term “energy window” does not necessarily imply that energy is delivered uniformly throughout the region comprising
  • some energy window implementations may comprise a series of termini or other regions within which energy is delivered with interspersed regions within which no energy, or less energy, is delivered. This configuration may be useful for some implementations to allow for alteration of certain tissue areas with interspersed areas within which tissue is not altered, or at least is less altered. This may have some advantages for
  • electronically energized energy window 107 may be omitted.
  • FIG. 1 a is a perspective view of an embodiment of a TDM comprising a tip 101 , a shaft 102 and a handle 103. Electro-coagulation and electro-cutting energy arrives in electrical conduits 111 and/or 112 and may travel by wiring through the handle and shaft to termini 107a, which are
  • Electro-cutting and electro-coagulation currents may be controlled outside the TDM at an electrosurgical generator, such as the Bovie Aaron 1250TM or Bovie Icon GPTM.
  • the tip may measure about 1 cm in width and about 1-2 mm in thickness. Sizes of about one-fifth to about five times these dimensions may also have possible uses. In some veterinary embodiments, tip sizes of about one-tenth to 20 times the
  • the tip can be a separate piece that is secured to shaft by a variety of methods such as a snap mechanism, mating grooves, plastic sonic welding, etc.
  • the tip can be integral or a continuation of shaft made of similar metal or materials.
  • the tip may also be constructed of materials that are both electrically non-conductive and of low
  • thermal conductivity such materials might comprise, for example, porcelain, ceramics, glass- ceramics, plastics, varieties of poiytetrafluoroethylene, carbon, graphite, and graphite-fiberglass composites.
  • the tip may be constructed of a support matrix of an insulating material (e.g., ceramic or glass material such as alumina, zirconia).
  • an insulating material e.g., ceramic or glass material such as alumina, zirconia.
  • the protrusions may comprise bulbous protrusions.
  • the tip shown in this embodiment has four relative protrusions and three relative recessions and provides for a monopolar tip conductive
  • All of the axes of the relative protrusions of the tip depicted in this embodiment extend at least substantially parallel to the axis of the shaft of the TDM (as viewed from Top).
  • surgeons may use methods of defining and or dissecting a target area by entering through an incision and then moving the TDM tip in a primarily axial direction forward and backward and reorienting the
  • the tip 101 may alternatively be made partially or completely of concentrically laminated or annealed-in wafer layers of materials that may include plastics, silicon, glass, glass/ceramics, cermets or ceramics. Lysing elements 105 may also be made 260 partially or completely of a cermet material. Alternatively, in a further embodiment the tip may be constructed of insulation covered metals or electroconductive materials.
  • the shaft may be flat, rectangular or geometric in cross-section or substantially flattened. In some embodiments, smoothing of the edges of the shaft may reduce friction on the skin surrounding the entrance wound. In some further embodiments, the shaft may be made of
  • the shaft may have a length of about 10-20cm. In some embodiments the handle may have a length of about 8-18cm.
  • shaft plastics such as polytetrafiuoroethy!ene may act as insulation
  • the shaft may
  • an electrically conductive element internal to shaft may be provided to conduct electrical impulses
  • an external power/control unit such as a ValleylabTM electrosurgical
  • energy windows 107 and/or 108 may only be substantially planar, or may take on other cross-sectional shapes that may correspond with a portion of the shape of the shaft, such as arced, stair-step, or other geometric shapes/curvatures.
  • energy window 107 is
  • an energy window may be positioned elsewhere on the shaft 102 or tip 101 of the wand, and still be considered adjacent to protrusions 104.
  • energy window 108 would still be considered adjacent to protrusion 104.
  • an energy window was placed on handle 103, such an
  • the conduit may also contain electrical control wires to aid in device operation.
  • electrically conductive tissue lysing elements 105 Partially hidden from direct view in FIGS. 1 a & 1 b, and located in the grooves defined by protrusions 104 are electrically conductive tissue lysing elements 105, which, when powered by an
  • electrosurgical generator effects lysing of tissue planes on forward motion of the device.
  • 290 lysing elements may be located at the termini of conductive elements.
  • one or more sensors such as for example sensors 110 and 114 may be positioned on the device.
  • the sensors 110 and 114 may comprise any of the sensors described in the specification herein.
  • Other embodiments may comprise one or more sensors on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the
  • Sensors that may be useful include thermal sensors, photoelectric or photo optic sensors, cameras, etc.
  • one or more sensors may be used to monitor the local post passage electrical impedance or thermal conditions that may exist near the distal tip of the shaft or on the tip.
  • Some embodiments may also comprise one or more sensors incorporating MEMS (Micro Electro-Mechanical Systems) technology, such as MEMS
  • Such sensors may be positioned at any number of locations on the TDM, including within the handle in some embodiments. In some
  • sensor 114 may comprise fiberoptic elements.
  • the sensor can be configured to sense a temperature of tissue adjacent to the apparatus.
  • the temperature sensor may alternatively be configured or sense a temperature of one or more fluids adjacent to
  • the apparatus such as for example tissue fluids and/or fluids introduced by the surgeon.
  • Temperature and impedance values may be tracked on a display screen or directly linked to a microprocessor capable of signaling control electronics to alter the energy delivered to the tip when preset values are approached or exceeded.
  • Typical instrumentation paths are widely known, such as thermal sensing thermistors, and may feed to analog amplifiers which, in turn,
  • 310 feed analog digital converters leading to a microprocessor.
  • internal or external ultrasound measurements may also provide information which may be incorporated into a feedback circuit.
  • an optional mid and low frequency ultrasound transducer may also be activated to transmit energy to the tip and provide additional heating and may additionally improve lysing.
  • a flashing visible light source for example
  • an LED can be mounted on the tip may show through the tissues and/or organs to identify the location of the device.
  • one or more electromagnetic delivery elements 115 may be positioned on tip or shaft.
  • Other embodiments may comprise one or more electromagnetic delivery elements on any other suitable location on the TDM, including but not limited to on the
  • Electromagnetic delivery elements that may be useful include: LEDs, LASERS, fiberoptics, filaments, photoelectric materials, infrared emitters, etc.
  • Some embodiments may comprise a low cost, disposable, and one-time-use device.
  • tissue lysing elements be protected or coated with materials that include, but are not limited to, SilverglideTM non-stick surgical coating, platinum, palladium, gold and rhodium. Varying the amount of protective coating allows for embodiments of varying potential for obsolescence capable of either prolonging or shortening instrument life.
  • the electrically conductive lysing element portion of the tip may arise
  • the electrically conductive lysing element 105 may comprise an insert attached to a conductive element in the shaft or continuous with a formed conductive element coursing all or part of the shaft.
  • one or more electrically conductive elements or wiring in conduit 1 11 and/or 1 12 brings RF electrosurgical energy down the shaft to electrically conductive lysing elements 105 associated in part with the recessions.
  • the electrosurgical energy via conduit 11 1 is predominately electro-cutting and/or a blend.
  • the electrically conductive element or wiring may be bifurcated to employ hand switching if an optional finger switch is located on handle.
  • the electrically conductive element or wiring leading from the shaft into the handle may be bundled with other electrical conduits or energy delivering cables, wiring and the like and may exit the proximal handle as insulated general wiring to various generators (including electrosurgical), central processing units, lasers and other sources as have been described herein.
  • generators including electrosurgical
  • central processing units including lasers and other sources as have been described herein.
  • the plate making up lysing elements 105 may be sharpened or scalloped or made to slightly extend outwardly from the tip recessions into which the plate will fit.
  • the lysing element may be recessed into the relative recessions or grooves defined by the protrusions 104 or, alternatively, may be flush with protrusions 104. In some further adjustable embodiments, locations of the electrically
  • the plate which in some embodiments is between 0.01 mm and 1 mm thick, can be sharpened to varying degrees on its forward facing surface. It is possible that plate sharpness may increase the efficiency with which electricity will pass from the edge cutting the target tissue. Sometimes, however, proper function even when variably dull or unsharpened may be unhampered since electrosurgical cutting current may cut beyond the electroconductive edge by a distance of over 1 mm. In some embodiments, the plate thickness may vary from 0.001 mm to 3mm thick.
  • the electrically conductive lysing element may also exist in the shape of a simple wire of 0.1 mm and 1 mm 0.01 mm to 3mm. In some embodiments, the wire may measure between 0.01 mm to 3mm. Such a wire may be singly or doubly insulated as was described for the plate and may have the same electrical continuities as was discussed for the planar (plate) version.
  • an electrosurgical current for the electrically conductive lysing element is of the monopolar "cutting" variety and setting and may be delivered to the tip lysing conductor in a continuous fashion or, alternatively, a pulsed fashion.
  • the surgeon can control the presence of current by a foot pedal control of the electrosurgical generator or by button control on the shaft (forward facing button).
  • the amount of cutting current may be modified by standard interfaces or dials on the electrosurgical generator.
  • the electrosurgically energized tip current can be further pulsed at varying rates, by interpolating gating circuitry at some point external to the electrosurgical generator by standard mechanisms known in the art that may range from about 1 per second to about 60 per second. In some embodiments, the rate may vary from about 1 per second to about 150 per
  • the electrosurgically energized tip current can be further pulsed at varying rates by gating circuitry within the electrosurgical generator by standard mechanisms known in the art.
  • the electrically conductive lysing element is a monopolar tip in contact with conductive elements in the shaft leading to external surgical cable leading to an electrosurgical generator from which emanates a grounding or dispersive plate
  • Acceptable electrosurgical generators may include Valley Lab Force 1 BTM with maximum P-P voltage of 2400 on “cut” with a rated load of 300 Ohms and a maximum power of 200 Watts, 35 maximum P-P voltage of 5000 on "coagulate" with a rated
  • the tip may also be manufactured from
  • 390 multilayer wafer substrates comprised of bonded conductive strips and ceramics.
  • Suitable conductive materials include but are not limited to those already described for tip manufacture.
  • the electrically conductive lysing elements may be bifurcated or divided into even numbers at the relative recessions, insulated and energized by wiring to an even number of electrical conduits in a bipolar fashion and connected to the bipolar outlets of
  • the aforementioned electrosurgical generators Rings partly or completely encircling the shaft of the hand unit can be linked to a partner bipolar electrode at the tip or on the energy window.
  • Such bipolar versions may decrease the available power necessary to electrically modify certain tissues, especially thicker tissues.
  • the lysing elements may be divided into odd numbers yet still allow for bipolar flow between two or more elements as those
  • FIG. 1 b is a side elevation view of the embodiment previously depicted in FIG. 1a.
  • tip 101 may be made of materials that are both electrically non- conductive and of low thermal conductivity such as porcelain, epoxies, ceramics, glass- ceramics, plastics, or varieties of polytetraf!uoroethylene.
  • the tip may be made of materials that are both electrically non- conductive and of low thermal conductivity such as porcelain, epoxies, ceramics, glass- ceramics, plastics, or varieties of polytetraf!uoroethylene.
  • the tip may be made of materials that are both electrically non- conductive and of low thermal conductivity such as porcelain, epoxies, ceramics, glass- ceramics, plastics, or varieties of polytetraf!uoroethylene.
  • the tip may be made of materials that are both electrically non- conductive and of low thermal conductivity such as porcelain, epoxies, ceramics, glass- ceramics, plastics, or varieties of polytetraf
  • the relative recessions of the tip is the electrically conductive tissue lysing element 105 (usually hidden from view at most angles) which may have any geometric shape including a thin cylindrical wire; the electrically conductive lysing element can be in the shape of
  • Optimal materials may include but are not limited to steel, nickel, alloys, palladium, gold, tungsten, silver, copper, and platinum. Metals may become oxidized thus impeding electrical flow and function.
  • the geometry of the tip area may comprise protrusions that are not oriented along the axis of the shaft (as
  • Some embodiments may be configured to be modular and/or comprise disposable tips such that a surgeon can place an appropriate tip for a particular surgery on the shaft. Alternatively or additionally one or more of the tips may be disposable such that a surgeon may dispose of the tip after performing surgery
  • one or more suction/vacuum ports 117 may be provided on or about the tip or distal shaft.
  • the port(s) may be fluidly coupled with a vacuum; the vacuum may comprise a pump or a negative pressure chamber or a syringe at the end of a fluid conduit.
  • a fluid delivery port 116 may be provided.
  • the fluid delivery port may be coupled with a pump or high pressure fluid.
  • the port may be perpetually open such that fluid may be delivered
  • the port may be closed and selectively opened to deliver fluid therethrough.
  • Other embodiments may comprise one or more fluid ports on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft. Fluid ports that may be useful may comprise channels within the TDM, polymer lines, hoses, etc. Fluids that may
  • ionic fluids such as saline, medicines (including but not limited to antibiotics, anesthetics, antineoplastic agents, bacteriostatic agents, etc.), non-ionic fluids, and or gasses (including but not limited to nitrogen, argon, air, etc.).
  • medicines including but not limited to antibiotics, anesthetics, antineoplastic agents, bacteriostatic agents, etc.
  • non-ionic fluids including but not limited to nitrogen, argon, air, etc.
  • fluids may be under higher pressures or sprayed. It should be understood that although these elements (116 & 117) are not depicted in every one of the other figures, any of
  • the embodiments described herein may include one or more such elements.
  • a vibration means 170b may be positioned in the handle.
  • Other embodiments may comprise one or more vibration means on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft.
  • suitable vibration means may include piezoelectric materials, ultrasonic motors 445 with stators, piezoelectric actuators, vibration motor such as an off-center weight mounted on a gear, etc.
  • Some vibration means may be configured to emit ultrasound in the 20-40kHz range.
  • Yet other vibration means may include electromagnet drivers with a frequency of operation in the range of 150-400Hz.
  • one or more vibration means may be used to provide additional forces which may facilitate passage of the TDM.
  • one or more vibration means may be used to provide additional forces which may facilitate passage of the TDM.
  • one or more vibration means may be used to provide additional forces which may facilitate passage of the TDM.
  • one or more vibration means may be used to provide additional forces which may facilitate passage of the TDM.
  • one or more vibration means may be
  • vibration means may be used to reduce debris on the electrosurgical or other
  • a vibration means may be directly or indirectly connected to one or more of the lysing elements. Some vibration means may help to decrease and/or remove debris. In some embodiments use of a vibration means may, also or alternatively, be used to assist in migrating the TDM through tissue during the procedure.
  • a vibration means having a lower frequency may be particularly useful for assisting in such migration.
  • positioning the vibration means closer to a handle of the TDM may facilitate such migration as well.
  • positioning the vibration means on or near the tip, and/or using a higher frequency vibrations means may be particularly useful for preventing buildup of debris on the tip.
  • antenna 118 represents an antenna configured to deliver a signal to a receiver unit.
  • antenna 118 may comprise a radiofrequency identification (RFID) TAG.
  • RFID tag may comprise an RFID transponder.
  • RFID tag may comprise a passive tag. It should be understood that antenna 118 is not depicted in every one of the other figures, any of the embodiments described herein
  • the RFID transponder may comprise a microchip, such as a microchip having a rewritable memory.
  • the tag may measure less than
  • a reader may generate an alternating electromagnetic field which activates the RFID transponder and data may be sent via frequency modulation.
  • the position of the RFID tag or other antenna may be determined by an alternating electromagnetic field in the ultra-high frequency range. The position may be related to a 3 dimensional mapping of the subject.
  • the reader may generate an
  • the alternating electromagnetic field may be in the shortwave (13.56MHz) or UHF (865-869MHz) frequency.
  • Examples of potentially useful systems and methods for mapping/tracking a surgical instrument in relation to a patient's body may be found in U.S. Patent Application Publication No. 2007/0225550 titled "System and Method for 3-D Tracking of Surgical Instrument in Relation to Patient Body, which
  • a transmission unit may be provided that may generate a high- frequency electromagnetic field configured to be received by an antenna of the RFID tag or another antenna.
  • the antenna may be configured to create an inductive current from the electromagnetic field. This current may activate a circuit of the tag, which may result in
  • the frequency of the electromagnetic radiation emitted by the tag may be distinct from the radiation emitted from the transmission unit. In this manner, it may be possible to identify and distinguish the two signals. In some embodiments, the frequency of the signal from the tag may lie within a side range of
  • antenna 118 may comprise a Bluetooth antenna. In such embodiments,
  • multiple corresponding Bluetooth receivers at known locations may be configured to sense signal strengths from the Bluetooth antenna 118 and triangulate such data in order to localize the signal from the Bluetooth antenna 118 and thereby locate the TDM within a patient's body.
  • Other embodiments may be configured to use angle-based, electronic localization
  • Some such embodiments may comprise use of directional antennas, which may be useful to increase the accuracy of the localization.
  • Still other embodiments may comprise use of other types of hardware and/or signals that may be useful for localization, such as WIFI and cellular signals, for example.
  • One or more receiver units may be set up to receive the signal from the tag.
  • the strength of the signal at various receiver units, the distances from the various receiver units may be determined. By so determining such distances, a precise location of the TDM relative to a patient and/or a particular organ or other surgical site on the patient may be determined.
  • a display screen with appropriate software may be coupled with the RFID or other localization technology to allow a surgeon to visualize at least an
  • Some embodiments may be further configured such that data from the antenna(s) may be used in connection with sensor data from the TDM.
  • TDMs comprising one or more sensors may be further configured with one or more RFID tags.
  • data from the one or more sensors may be paired or otherwise used in connection with
  • some embodiments may be configured to provide information to a surgeon regarding one or more locations on the body from which one or more sensor readings were obtained.
  • information regarding tissue temperature may be combined with a location from which such tissue temperature(s) were taken. In this manner, a surgeon may be provided with specific
  • a visual display may be provided comprising an image of the patient's body and/or one or more selected regions of a patient's body.
  • Such a system may be configured so as to provide a visual indication for one or more regions within the image
  • a display of a patient's liver may change colors at locations on the display that correspond with regions of the liver that have experienced a sufficient degree of fibrosis or other treatment.
  • Such regions may, in some embodiments, be configured such that pixels
  • Such sensors 110 and/or 1 14, 210 and/or 214, 310 and/or 314, 410 and/or 414, 510a and/or 514a, 510b and/or 514b, 610a and/or 614a, 610b and/or 614b, may be coupled with an antenna, which may send and/or receive one or more signals to/from a processing
  • such a signal may be transmitted following surgery.
  • the signals need not necessarily be transmitted wirelessly.
  • some embodiments may be configured to store data locally, after which a data module, such as a memory stick, may be removed from the TDM and uploaded to a separate computer for analysis.
  • tip 101 may be attached to a robotic arm. In some embodiments, tip
  • the robotic arm may comprise one or more motors such as a screw-drive motor, gear motor, hydraulic motors, etc.
  • the robotic arm system may comprise worm gearheads, video cameras, motor control circuits, monitors, remote control devices, illumination sources, tactile interface, etc.
  • FIG. 1 c is a front elevation view of an embodiment of the embodiment previously depicted in FIG. 1 a.
  • the relatively oval protrusions 104c may be shaped similarly to a commercial jetliner nose cone in order to reduce drag and lower resistance to facilitate tissue passage.
  • tip protrusion shapes may take on a wide variety of geometric shapes including, but not limited to, stacked rectangles or tapered thin rectangles as discussed elsewhere.
  • 555 may include, but should not be limited to: spheroid, sphere, sphere on cylinder, sphere on pyramid, sphere on cone, cone, cylinder, pyramid, and polyhedron.
  • FIG. 1 d is a front elevation view of an alternative embodiment having two protrusions 104d and one lysing segment (recession) wherein the lysing segment 105d connecting the two protrusions is substantially centered midway between the upper and lower portions of the
  • FIG. 1e is a front elevation view of another embodiment having two protrusions and one lysing segment 105e wherein the lysing segment connecting the two protrusions 104e is substantially centered in the upper third of the
  • the vertical height of the protrusions may be about 3mm and the horizontal width may be about 2mm.
  • the lysing segment may be placed about 1 mm from the upper portion of the protrusion.
  • FIG. 1f is a front elevation view of another embodiment having two protrusions and one
  • the vertical height of the protrusions may be about 3mm and the horizontal width may be about 2mm.
  • the lysing segment may be placed about 2mm from the upper portion of the protrusion.
  • embodiments may be configured such that the position of the lysing segment(s) relative to the protrusions is adjustable, such as adjustable between the embodiments shown in Figures 1 d-1f.
  • FIG. 1g is a cross-sectional view of an embodiment of a TDM illustrating some examples of some of the canals that may be used with the device.
  • canal 130 may comprise an electrode canal for delivering electrical energy to one or more of the lysing elements and/or the
  • Canal 132 may comprise an optics canal for delivering and/or receiving optical signals or energy, such as a LASER, fiber optics, intense pulse light, or for receiving an optical sensor.
  • Canal 134 may comprise a vacuum tube for sucking fluids away from the surgical site, such as bodily fluids and/or fluids introduced by the TDM during the surgery.
  • One or more of these canals may be configured for delivering one or more fluids using the TDM.
  • canal 136 may comprise a fluid delivery canal for delivering an ionic fluid, such as a saline solution. Canal 136 may be configured to deliver a fluid that is both ionic and an anesthetic, such as a tumescent anesthesia. In some embodiments, canal 136 may be configured to deliver a fluid containing multiple individual fluids, such as a Klein Formula. Canal 138 may serve as a coaxial cable canal, such as for delivering a microwave signal to the energy
  • Canals 140 and 142 may comprise duplicates of any one of the foregoing canals 130-138.
  • One or more of the canals 130-142 may be coated with copper or another conductive metal to insulate the signals from those within other canals.
  • any of the embodiments described herein may comprise one or more such canals configured for any of the uses described herein. 595
  • the canals shown in FIG. 1g are shown as having rectangular cross sections, any other cross sectional shape, including but not limited to circular cross sections, may be used.
  • FIGs. 1 h,i depict an embodiment that differs from the embodiment depicted in FIGs. 1a, b in that FIGs. 1 h,i lack or do not comprise energy windows 107 and/or 108.
  • Each of the other 600 elements depicted in FIGs. 1 h,i may be identical to the corresponding elements shown in FIGs.
  • FIG. 1 h is a perspective view of an embodiment of a TDM comprising tip 101 h and/or shaft 102h and/or handle 103h.
  • FIG. 1 h is a perspective view of an embodiment of a TDM comprising a tip 101 h, a shaft
  • External conduits 111 h and/or 112h may connect to electrically conductive elements to bring RF electrosurgical energy from an electrosurgical generator down the shaft 102h to electrically conductive lysing elements 105h mounted in the recessions in between the
  • one or more sensors such as for example sensors 110 and 114 may be positioned on the device.
  • the sensors 110 and 114 may comprise any of the sensors described in the specification herein.
  • Other embodiments may comprise one or more sensors on any other suitable location on the TDM, including but not limited to on the protrusions or
  • Sensors that may be useful include thermal sensors, photoelectric or photo optic sensors, cameras, etc.
  • one or more sensors may be used to monitor the local post passage electrical impedance or thermal conditions that may exist near the distal tip of the shaft or on the tip.
  • Some embodiments may also comprise one or more sensors incorporating MEMS (Micro Electro-Mechanical Systems) technology,
  • sensor 620 such as MEMS gyroscopes, accelerometers, and the like. Such sensors may be positioned at any number of locations on the TDM, including within the handle in some embodiments.
  • sensor 114 may comprise fiberoptic elements.
  • the sensor can be configured to sense a temperature of tissue adjacent to the apparatus.
  • the temperature sensor may alternatively be configured or sense a temperature of one or more
  • fluids adjacent to the apparatus such as for example tissue fluids and/or fluids introduced by the surgeon.
  • one or more electromagnetic delivery elements 115h may be positioned on tip or shaft.
  • Other embodiments may comprise one or more electromagnetic delivery elements on any other suitable location on the TDM, including but not limited to on the 630 protrusions or otherwise on the tip, and on the shaft.
  • Electromagnetic delivery elements that may be useful include: LEDs, LASERS, fiberoptics, filaments, photoelectric materials, infrared emitters, etc.
  • FIG. 1 i is a side elevation view of the embodiment previously depicted in FIG. 1 h.
  • the geometry of the tip area may comprise protrusions that are not
  • tip area geometries are depicted in Figures 5a,b,c,d. Some embodiments may be configured to be modular and/or comprise disposable tips such that a surgeon can place an appropriate tip for a particular surgery on the shaft. In some embodiments, one or more suction/vacuum ports 117i may be provided on or about the tip or distal shaft. The port(s)
  • the 640 may be fluidly coupled with a vacuum; the vacuum may comprise a pump or a negative
  • a fluid delivery port 116i may be provided. It should be understood that although these elements
  • a vibration means 170h may be positioned in the handle.
  • 118i represents an antenna configured to deliver a signal to a receiver unit.
  • antenna 118i may comprise a radiofrequency
  • the RFID tag may comprise an RFID
  • the RFID tag may comprise a passive tag.
  • antenna 118i is not depicted in every one of the other figures, any of the embodiments described herein may comprise one or more such elements.
  • Other embodiments may comprise one or more antenna on any other suitable location on the TDM, including but not
  • the RFID transponder may comprise a microchip, such as a microchip having a rewritable memory.
  • the tag may measure less than a few millimeters.
  • a reader may generate an alternating electromagnetic field which activates the RFID transponder and data may be sent via
  • the position of the RFID tag or other antenna may be determined by an alternating electromagnetic field in the ultra-high frequency range.
  • the position may be related to a 3 dimensional mapping of the subject.
  • the reader may generate an alternating electromagnetic field.
  • the alternating electromagnetic field may be in the shortwave (13.56MHz) or UHF (865-869MHz)
  • antenna 118 may be a Bluetooth antenna.
  • Other embodiments may be
  • Some such embodiments may comprise use of directional antennas, which may be useful to increase the accuracy of the localization.
  • Still other embodiments may comprise use of other types of hardware and/or signals that may be useful for localization, such as WIFI and cellular signals, for example.
  • Such sensors 11 Oh and/or 114h may be coupled with an antenna, which may send and/or receive one or more signals to/from a processing unit.
  • data from such sensors resulting from tissue and/or fluid analysis using such sensors may be stored locally and transmitted later.
  • such a signal may be transmitted following surgery. In such implementations, the signals need not necessarily be transmitted
  • some embodiments may be configured to store data locally, after which a data module, such as a memory stick, may be removed from the TDM and uploaded to a separate computer for analysis.
  • a data module such as a memory stick
  • tip 101 h may be attached to a robotic arm. In some embodiments, tip 101 h and portion of shaft 102h may be attached to a robotic arm. In some embodiments tip
  • the robotic arm may comprise one or more motors such as a screw-drive motor, gear motor, hydraulic motors, etc.
  • the robotic arm system may comprise worm gearheads, video cameras, motor control circuits, monitors, remote control devices, illumination sources, tactile interface, etc.
  • a feedback means may be present for providing information to a user to avoid excess energy delivery to tissue.
  • the feedback means may be configured to notify a user when a temperature of tissue adjacent to the apparatus has reached a predetermined threshold temperature.
  • the feedback means may comprise an antenna.
  • the antenna may comprise a radiofrequency identification tag.
  • the radiofrequency identification tag comprises a passive tag.
  • the visual information may comprise an indication of the one or more regions that have reached a predetermined threshold temperature.
  • a feedback means may be present for providing information to a user to avoid excess energy delivery to tissue.
  • the feedback means may be
  • the feedback means may comprise an antenna.
  • the antenna may comprise a radiofrequency identification tag.
  • the radiofrequency identification tag comprises a passive tag.
  • the radiofrequency identification tag may be configured to allow for determining
  • a temperature sensor may be configured to sense a temperature of tissue positioned adjacent to the apparatus during an operation.
  • a display unit may be configured to display information to a user during an operation.
  • the display unit may be configured to display visual information comprising information from the
  • the visual information may comprise an indication of the one or more regions that have reached a predetermined threshold temperature.
  • an alternating electromagnetic field may be one of a shortwave and UHF frequency.
  • At least one lysing element may comprise at least one lysing segment.
  • at least one lysing element may be positioned between at least two adjacent protrusions among the plurality of protrusions and/or an antenna positioned on the tissue dissecting and modifying wand and configured to provide location data regarding a location of the tissue dissecting and modifying wand during a procedure and/or receiving data from the
  • At least one lysing element may comprise at least one lysing segment.
  • FIG. 2a is a perspective view of an embodiment of a TDM with an alternative energy window 207 on the upper side of the device configured to hold a thermochromic film. It should be noted
  • the term "energy window” is intended to encompass what is referred to as a planar-tissue- altering-window/zone in U.S. Patent No. 7,494,488 and, as described herein, need not contain a thermochromic film in all embodiments.
  • the "energy window” may comprise a variety of other energy emitting devices, including radiofrequency, thermochromic, intense pulsed light, LASER, thermal, microwave and ultrasonic. It should also be understood
  • energy window does not necessarily imply that energy is delivered uniformly throughout the region comprising the energy window. Instead, some energy window
  • implementations may comprise a series of termini or other regions within which energy is delivered with interspersed regions within which no energy, or less energy, is delivered. This configuration may be useful for some implementations to allow for alteration of certain tissue
  • certain components of an energy window such as the electro- conductive components of the energy window, could comprise a cermet. It is contemplated that in alternative embodiments, Thermochromic Containing Energy Window 207 may be omitted.
  • FIG. 2a is a perspective view of an embodiment of a TDM comprising a tip 201 , a shaft 202 and a handle 203.
  • Electrosurgical energy may be delivered in electrical conduits 211 and/or 212 whereas LASER energy may be delivered by fiberoptic 222 or a waveguide and may travel by fiberoptic or waveguide through the handle and shaft to energy window 207, which may comprise a thermochromic film.
  • a second energy window 208 may also be included in some
  • Electro-cutting and electro-coagulation currents may be controlled outside the TDM at an electrosurgical generator, such as the Bovie Aaron 1250TM or Bovie Icon GPTM.
  • the tip may measure about 1cm in width and about 1-2 mm in thickness. Sizes of about one-fifth to about five times these dimensions may also have possible uses.
  • tip sizes of about one-tenth to 20 times the aforementioned dimensions may also have possible uses.
  • the tip can be a separate piece that may be secured to a shaft by a variety of methods, such as a snap mechanism, mating grooves, plastic sonic welding, etc.
  • the tip can be integral or a continuation of a shaft made of similar metal(s) or material(s).
  • the tip may also be constructed of materials that are both electrically non- conductive and of low thermal conductivity; such materials might comprise, for example, porcelain, ceramics, glass-ceramics, plastics, varieties of polytetrafluoroethylene, carbon, graphite, and graphite-fiberglass composites.
  • the tip may be constructed of a support matrix of an insulating
  • Conduits 211 and/or 212 may connect to electrically conductive elements to bring RF electrosurgical energy from an electrosurgical generator down the shaft 202 to electrically conductive lysing elements 205 mounted in the recessions in between protrusions 204.
  • the protrusions may comprise bulbous protrusions.
  • the tip shown in this embodiment has four relative
  • All of the axes of the relative protrusions of the tip depicted in this embodiment extend at least substantially parallel to the axis of the shaft of the TDM (as viewed from Top).
  • surgeons may use methods of defining and or dissecting a target area by entering through an incision and then
  • the tip 201 may alternatively be made partially or completely of concentrically laminated or annealed-in wafer layers of materials that may include plastics, silicon, glass, glass/ceramics or ceramics. Lysing elements 205 may also be made
  • the tip 775 partially or completely of a cermet material.
  • the tip may be constructed of insulation covered metals or electroconductive materials.
  • the shaft may be flat, rectangular, or geometric in cross-section, or may be substantially flattened. In some embodiments, smoothing of the edges of the shaft may reduce friction on the tissues surrounding the entrance wound. In some further embodiments, the shaft
  • 780 may be made of metal or plastic or other material with a completely occupied or hollow interior that can contain insulated wires, electrical conductors, fluid/gas pumping or suctioning conduits, fiber-optics, or insulation.
  • shaft plastics such as polytetrafluoroethylene, may act as insulation about wire or electrically conductive elements.
  • the shaft may act as insulation about wire or electrically conductive elements.
  • the shaft may act as insulation about wire or electrically conductive elements.
  • an electrically conductive element internal to the shaft may be provided to conduct electrical impulses or RF signals from an external power/control unit (such as a ValleylabTM
  • windows 207 and/or 208 may only be substantially planar, or may take on other cross-sectional shapes that may correspond with a portion of the shape of the shaft, such as arced, stair-step, or other geometric shapes/curvatures.
  • energy window 208 may comprise another thermochromic film. In the embodiments depicted in FIGS. 2a & 2b, energy
  • window 207 is adjacent to protrusions 204, however other embodiments are contemplated in which an energy window may be positioned elsewhere on the shaft 202 or tip 201 of the wand, and still be considered adjacent to protrusions 204. For example, in an embodiment lacking energy window 207, but still comprising energy window 208, energy window 208 would still be considered adjacent to protrusion 204. However, if an energy window was placed on handle
  • the conduit(s) may also contain electrical control wires to aid in device operation.
  • the conduit(s) may also contain electrical control wires to aid in device operation.
  • sensors 805 lysing elements may be located at the termini of conductive elements.
  • one or more sensors such as for example sensors 210 and 214 may be positioned on the device.
  • the sensors 210 and 214 may comprise any of the sensors described in the specification herein.
  • Other embodiments may comprise one or more sensors on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the
  • Sensors that may be useful include thermal sensors, photoelectric or photo optic sensors, cameras, etc.
  • one or more sensors may be used to monitor the local post passage electrical impedance or thermal conditions that may exist near the distal tip of the shaft or on the tip.
  • Some embodiments may also comprise one or more sensors incorporating MEMS (Micro Electro-Mechanical Systems) technology, such as MEMS 815 gyroscopes, accelerometers, and the like. Such sensors may be positioned at any number of locations on the TDM, including within the handle in some embodiments.
  • MEMS Micro Electro-Mechanical Systems
  • sensor 214 may comprise fiberoptic elements.
  • the sensor can be configured to sense a temperature of tissue adjacent to the apparatus.
  • the temperature sensor may alternatively be configured or sense a temperature of one or more fluids adjacent to
  • the apparatus such as for example tissue fluids and/or fluids introduced by the surgeon.
  • Temperature and impedance values may be tracked on a display screen or directly linked to a microprocessor capable of signaling control electronics to alter the energy delivered to the tip when preset values are approached or exceeded.
  • Typical instrumentation paths are widely known, such as thermal sensing thermistors, and may feed to analog amplifiers which, in turn,
  • a microprocessor 825 feed analog digital converters leading to a microprocessor.
  • internal or external ultrasound measurements may also provide information which may be incorporated into a feedback circuit.
  • an optional mid and low frequency ultrasound transducer may also be activated to transmit energy to the tip and provide additional heating and may additionally improve lysing.
  • a flashing visible light source for example, a flashing visible light source, for
  • an LED can be mounted on the tip may show through the tissues and/or organs to identify the location of the device.
  • one or more electromagnetic delivery elements 215 may be positioned on tip or shaft.
  • Other embodiments may comprise one or more electromagnetic delivery elements on any other suitable location on the TDM, including but not limited to on the
  • Electromagnetic delivery elements that may be useful include: LEDs, LASERS, fiberoptics, filaments, photoelectric materials, infrared emitters, etc.
  • FIG. 2b is a side elevation view of the embodiment previously depicted in FIG. 2a.
  • tip 201 which terminates in protrusions 206 may be made of materials
  • the tip may be made from metals or electroconductive materials that are completely or partially insulated. Note the relative protrusions and relative recessions are not completely visible from this viewing angle.
  • the tip shown in this embodiment has four relative protrusions and three
  • the electrically conductive tissue lysing element(s) 205 (usually hidden from view at most angles), which may have any geometric shape including a thin cylindrical wire, may be positioned within the relative recessions of the tip.
  • the electrically conductive lysing element can be in the shape of a plate or plane or wire and made of any metal or alloy that does not melt
  • Optimal materials may include but are not limited to steel, nickel, alloys, palladium, gold, tungsten, silver, copper, and platinum. Metals may become oxidized thus impeding electrical flow and function.
  • locations of the electrically conductive lysing elements with respect to the protrusions may be adjusted by MEMS or microelectronics.
  • thermochromic films have principally seen use as sensors or detection devices and thus absorb energy and contribute to modifying said energy into quantifiable information or data; for example, applying organic thermochromic indicators to surgical instruments with radiofrequency power "jaws" to visually indicate to a surgeon when a given temperature is reached, however such an "organically sensitive" device has replacement
  • thermochromic films are presented for a diametrically opposite purpose: to pump a defined quantity of energy into a living system to alter tissue.
  • thermochromic films may have an extremely well
  • thermochromic materials tend to have a fast response time over a broad wavelength band and return to the transparent state when the LASER beam subsides. So, thermochromic materials may act more as a safety switch wherein, instead of having a separate sensor for temperature, a "fail-safe" mechanism would be to set
  • thermochromic to shut down transmission if, using round numbers only, for example, the temperature of the thermochromic film exceeded 100 degrees centigrade depending upon the speed at which the TDM was moving.
  • the temperature threshold for limiting energy transmission ranges from about 65 to 90° C. In some such embodiments, the threshold may be between 68 to 75° C. Vanadium Dioxide (V0 2 ) as a
  • thermochromic film may see many potential uses, as it has such a rapid transition (in
  • V0 2 is a transparent semiconductor, but at just a few degrees higher, V0 2 may display its usefulness as a "reflective window coating.” V0 2 's rapid phase transition may see
  • the geometry of the tip area may comprise protrusions that are not oriented along the axis of the shaft (as seen from a top view); some of these alternative embodiments for tip area geometries are depicted in Figures 5a,b,c,d,e,f,g,h and Figures 6a,b,c,d. Some embodiments may be configured to be modular and/or comprise disposable tips
  • one or more of the tips may be disposable such that a surgeon may dispose of the tip after performing surgery and install a new tip for subsequent surgeries or a continuation of the current surgery with a new tip.
  • one or more suction/vacuum ports 217b may be provided on or
  • the port(s) may be fluidly coupled with a vacuum; the vacuum may comprise a pump or a negative pressure chamber or a syringe at the end of a fluid conduit.
  • Other embodiments may comprise one or more suction/vacuum ports on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft.
  • a fluid delivery port 216b may be provided.
  • the fluid delivery port may be coupled with a pump or high pressure fluid.
  • the port may be perpetually open such that fluid may be delivered therethrough upon actuation of a pump or fluid pressure system.
  • the port may be closed and selectively opened to deliver fluid therethrough.
  • Other embodiments may comprise one or more fluid ports on any other suitable location on the TDM, including but not
  • Fluid ports that may be useful may comprise channels within the TDM, polymer lines, hoses, etc. Fluids that may emanate from the outlet may comprise ionic fluids such as saline, medicines (including but not limited to antibiotics, anesthetics, antineoplastic agents, bacteriostatic agents, etc.), non-ionic fluids, and or gasses (including but not limited to nitrogen, argon, air, etc.).
  • ionic fluids such as saline, medicines (including but not limited to antibiotics, anesthetics, antineoplastic agents, bacteriostatic agents, etc.), non-ionic fluids, and or gasses (including but not limited to nitrogen, argon, air, etc.).
  • fluids may be under higher pressures or sprayed. It should be understood that although these elements (216b & 217b) are not depicted in every one of the other figures, any of the embodiments described herein may include one or more such elements.
  • a vibration means 270b may be positioned in the handle.
  • Other embodiments may comprise one or more vibration means on any other suitable location on the
  • TDM including but not limited to on the protrusions or otherwise on the tip, and on the shaft.
  • vibration means may include piezoelectric materials, ultrasonic motors with stators, piezoelectric actuators, vibration motor such as an off-center weight mounted on a gear, etc. Some vibration means may be configured to emit ultrasound in the 20-40kHz range. Yet other vibration means may include electromagnet drivers with a frequency of operation in
  • one or more vibration means may be used to provide additional forces which may facilitate passage of the TDM.
  • one or more vibration means may be used to reduce debris on the electrosurgical or other components of the TDM.
  • a vibration means may be directly or indirectly connected to one or more of the lysing elements.
  • 218b represents an antenna, such as an RFID TAG or
  • antenna 218b comprises an RFID tag
  • the RFID tag may comprise an RFID transponder.
  • the RFID tag may comprise a passive tag. It should be understood that antenna 218b is not depicted in every one of the other figures, any of the embodiments described herein may comprise one or more such elements.
  • an RFID transponder or another antenna may comprise a microchip, such as a microchip having a rewritable memory.
  • the tag may measure less than a few millimeters.
  • a reader may generate an alternating
  • the position of the RFID tag or other antenna may be determined by an alternating electromagnetic field in the ultra-high frequency range.
  • the position may be related to a 3 dimensional mapping of the subject.
  • the reader may generate an alternating electromagnetic field.
  • the position of the RFID tag or other antenna may be determined by an alternating electromagnetic field in the ultra-high frequency range.
  • the position may be related to a 3 dimensional mapping of the subject.
  • the reader may generate an alternating electromagnetic field.
  • 935 alternating electromagnetic field may be in the shortwave (13.56MHz) or UHF (865-869MHz) frequency.
  • tip 201 may be attached to a robotic arm. In some embodiments, tip 201 and portion of shaft 202 may be attached to a robotic arm. In some embodiments tip 201 and/or a portion of shaft 202 and/or a portion shaft and/or portion of handle 203 may be
  • the robotic arm may comprise one or more motors such as a screw-drive motor, gear motor, hydraulic motors, etc.
  • the robotic arm system may comprise worm gearheads, video cameras, motor control circuits, monitors, remote control devices, illumination sources, tactile interface, etc.
  • FIG. 2c depicts an embodiment of the thermochromic energy window embodiment
  • This depicted embodiment includes energy window 207, which is configured to comprise all or a portion of a thermochromic media 220, which is, in turn, substantially covered by a covering layer 221.
  • fiber optic 222 carries LASER energy derived from a LASER generator, into and through the handle, down the shaft and into the thermochromic media.
  • a wave guide may carry the LASER
  • Vanadium Dioxide may be used as the inorganic thermochromic material and may be covered by a covering layer.
  • the Vanadium Dioxide layer is about 200-300 microns in thickness. In some embodiments, the Vanadium Dioxide layer ranges from about 10 microns to about 1000 microns.
  • the covering layer is silica. In some embodiments, the covering
  • thermochromic 955 layer comprises a transparent dielectric, quartz, alumina, sapphire, diamond, and/or ceramic.
  • plastics may serve as a covering layer.
  • an Nd:YAG (neodymium yttrium, aluminum, garnet) LASER may energize the thermochromic media.
  • a CandelaTM Gentle YAGTM1064nm LASER is configured to energize a fiberoptic that thereupon leads into the TDM thermochromic window.
  • Manganese Strontium Oxide may serve as the thermochromic layer.
  • diode LASERS may be used to energize the thermochromic material.
  • metal vapor LASERS and/or semiconductor-based LASERS may be used to energize the thermochromic material.
  • Metal vapor LASERS may include, but are not limited to, copper vapor and gold vapor. The power source may be more helpful if it runs continuously but
  • thermochromic effect when V0 2 changes in reflectivity.
  • Fiberoptics may carry the LASER energy.
  • a wave guide carries the LASER energy to the thermochromic film.
  • the thermochromic film may be configured to measure about 2x1 cm in
  • thermochromic film may be configured to deliver about
  • Some embodiments may comprise a tip comprising a plurality of protrusions and/or at least one lysing element positioned between each of the protrusions and/or a tip positioned at a distal end of the shaft, wherein the tip comprises a plurality of protrusions and at least one lysing
  • thermochromic media configured to absorb electromagnetic radiation energy and emit heat energy from the energy window
  • energy window is positioned and configured to deliver the heat energy from the apparatus to tissue adjacent to the apparatus during an operation.
  • 980 embodiments may further comprise a LASER that is configured to deliver energy to the
  • thermochromic media such that the thermochromic media can emit heat energy from the energy window. Still other embodiments may comprise a fiber optic cable configured to deliver LASER energy to the thermochromic media. In some embodiments the thermochromic media may be configured such that the temperature of the energy window cannot exceed a threshold
  • At least one lysing element may comprise at least one lysing segment.
  • FIG. 3a is a perspective view of an embodiment of a tissue dissector and modifier with a target-tissue-impedance-matched-microwave-based energy window on the upper side of the device.
  • a target-tissue-impedance-matched-microwave emission system may be
  • a controllable solid state source e.g., MicroBlateTM
  • SHF super-high frequency
  • FIG. 3a is a perspective view of an embodiment of a TDM with an alternative energy window 307 on the upper side of the device configured to hold an array of impedance-matched- microwave emitting antennae.
  • energy window is intended to encompass what is referred to as a planar-tissue-altering-window/zone in U.S. Patent No.
  • the "energy window” may comprise a variety of other energy emitting devices, including radiofrequency, intense pulsed light, LASER, thermal, and ultrasonic. It should also be understood that the term “energy window” does not necessarily imply that energy is delivered uniformly throughout the region comprising the energy window. Instead, some energy window
  • 1010 implementations may comprise a series of termini or other regions within which energy is
  • window 307 may be omitted.
  • FIG. 3a is a perspective view of an embodiment of a TDM comprising a tip 301 , a shaft 302 and a handle 303.
  • Electrosurgical energy may be delivered in conduits 311 and/or 312, whereas gigahertz microwave energy may be delivered by coaxial cable bundle 322 through the
  • 1020 handle and shaft to energy window 307, which may comprise four antennae termini. Some embodiments comprise between 1 and 10 antennae. Some embodiments may comprise a flat microwave emitting device. A second energy window 308 may also be included in some embodiments, and may comprise yet another microwave emitter or another variety of energy emitting device. Electro-cutting and electro-coagulation currents may be controlled outside the
  • the tip may measure about 1cm in width and about 1-2 mm in thickness. Sizes of about one-fifth to about five times these dimensions may also have possible uses. In some veterinary embodiments, tip sizes of about one-tenth to 20 times the aforementioned dimensions may also have possible uses.
  • the tip can be a separate piece that may be secured to a shaft by a variety of methods, such as a snap mechanism, mating grooves, plastic sonic welding, etc.
  • the tip can be integral or a continuation of a shaft made of similar metal(s) or material(s).
  • the tip may also be constructed of materials that are both electrically non-conductive and of low thermal conductivity; such
  • the tip may be constructed of a support matrix of an insulating material (e.g., ceramic or glass material such as alumina, zirconia).
  • Conduit 311 may connect to electrically conductive elements to bring RF electrosurgical energy from an electrosurgical
  • the protrusions may comprise bulbous protrusions.
  • the tip 301 may alternatively be made partially or completely of concentrically laminated or annealed-in wafer layers of materials that may include plastics, silicon, glass, glass/ceramics or ceramics. Alternatively, in a further embodiment
  • the tip may be constructed of insulation covered metals or electroconductive
  • the shaft may be flat, rectangular, or geometric in cross- section, or may be substantially flattened. In some embodiments, smoothing of the edges of the shaft may reduce friction on the tissues surrounding the entrance wound. In some further embodiments, the shaft may be made of metal or plastic or other material with a completely
  • 1050 occupied or hollow interior that can contain insulated wires, electrical conductors, fluid/gas pumping or suctioning conduits, fiber-optics, or insulation.
  • shaft plastics such as polytetrafluoroethylene may act as insulation about wire or electrically conductive elements.
  • the shaft may act as insulation about wire or electrically conductive elements.
  • an electrically conductive element internal to shaft may be provided to conduct electrical impulses or RF signals from an external power/control unit (such as a ValleylabTM electrosurgical generator) to another energy window 308.
  • an external power/control unit such as a ValleylabTM electrosurgical generator
  • energy window 308 may only be substantially planar, or may take on other cross-sectional shapes that may correspond with a portion of the shape of the shaft, such as arced, stair-step, or other geometric shapes/curvatures.
  • energy window 308 may comprise another microwave emitter.
  • energy window 307 is adjacent to protrusions 304, however other embodiments are contemplated in which an energy
  • 1065 window may be positioned elsewhere on the shaft 302 or tip 301 of the wand, and still be
  • protrusions 304 considered adjacent to protrusions 304.
  • energy window 308 would still be considered adjacent to protrusion 304.
  • an energy window was placed on handle 303, such an energy window would not be considered adjacent to the protrusions 304.
  • the conduit(s) may also contain electrical control wires to aid in device operation.
  • electrically conductive tissue lysing elements 305 Partially hidden from direct view in FIGS. 3a & 3b, and located in the recessions defined by protrusions 304, are electrically conductive tissue lysing elements 305, which, when powered by an electrosurgical generator, effects lysing of tissue planes on forward motion of the device.
  • the lysing elements may be located at the termini of conductive elements.
  • one or more sensors such as for example sensors 310 and 314 may be positioned on the device.
  • the sensors 310 and 314 may comprise any of the sensors described in the specification herein.
  • Other embodiments may comprise one or more sensors on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft. Sensors that may be useful include thermal sensors,
  • one or more sensors may be used to monitor the local post passage electrical impedance or thermal conditions that may exist near the distal tip of the shaft or on the tip.
  • Some embodiments may also comprise one or more sensors incorporating MEMS (Micro Electro-Mechanical Systems) technology, such as MEMS gyroscopes, accelerometers, and the like. Such sensors may be positioned at
  • sensor 314 may comprise fiberoptic elements.
  • the sensor can be configured to sense a temperature of tissue adjacent to the apparatus during one or methods described herein.
  • the temperature sensor may alternatively be configured or sense a temperature of one or more fluids adjacent to the apparatus such as for example tissue fluids
  • Temperature and impedance values may be tracked on a display screen or directly linked to a microprocessor capable of signaling control electronics to alter the energy delivered to the tip when preset values are approached or exceeded.
  • Typical instrumentation paths are widely known, such as thermal sensing thermistors, and may feed to analog amplifiers which, in turn,
  • a flashing visible light source for example, a flashing visible light source, for example, a flashing visible light source, for example, a flashing visible light source, for example, a flashing visible light source, for example, a flashing visible light source, for example, a flashing visible light source, for example, a flashing visible light source, for example, a flashing visible light source, for example, a flashing visible light source, for example, a flashing visible light source, for
  • an LED can be mounted on the tip may show through the tissues and/or organs to identify the location of the device.
  • one or more electromagnetic delivery elements 315 may be positioned on tip or shaft.
  • Other embodiments may comprise one or more electromagnetic delivery elements on any other suitable location on the TDM, including but not limited to on the
  • Electromagnetic delivery elements that may be useful include: LEDs, LASERS, fiberoptics, filaments, photoelectric materials, infrared emitters, etc.
  • the lysing element may be recessed into the relative 1110 recessions or grooves defined by the protrusions 304 or, alternatively, may be flush with protrusions 304.
  • locations of the electrically conductive lysing elements with respect to the protrusions may be adjusted by diminutive screws or ratchets.
  • locations of the electrically conductive lysing elements with respect to the protrusions may be adjusted by MEMS or
  • the electrically conductive lysing element may also exist in the shape of a simple wire of 0.1 mm and 1 mm 0.01 mm to 3mm.
  • the wire may measure betweenO.OI mm to 3mm.
  • Such a wire may be singly or doubly insulated as was described for the plate and may have the same electrical continuities as was discussed for the
  • conductive lysing element is of the monopolar "cutting" variety and setting and may be delivered to the tip lysing conductor in a continuous fashion or, alternatively, a pulsed fashion.
  • the surgeon can control the presence of current by a foot pedal control of the electrosurgical generator or by button control on the shaft (forward facing button). The amount of cutting current
  • 1125 may be modified by standard interfaces or dials on the electrosurgical generator. In some embodiments,
  • the electrosurgically energized tip current can be further pulsed at varying rates, by interpolating gating circuitry at some point external to the electrosurgical generator by standard mechanisms known in the art, that may range from about 1 per second to about 60 per second. In some embodiments, the rate may vary from about 1 per second to about 150 per
  • the electrosurgically energized tip current can be further pulsed at varying rates by gating circuitry within the electrosurgical generator by standard mechanisms known in the art.
  • the geometry of the tip area may comprise protrusions that are not oriented along the axis of the shaft (as seen from a top view); some of these alternative
  • Some embodiments may be configured to be modular and/or comprise disposable tips such that a surgeon can place an appropriate tip for a particular surgery on the shaft.
  • one or more of the tips may be disposable such that a surgeon may dispose of the tip after performing surgery and install a new tip for subsequent surgeries or a
  • one or more suction/vacuum ports 317b may be provided on or about the tip or distal shaft.
  • the port(s) may be fluidly coupled with a vacuum; the vacuum may comprise a pump or a negative pressure chamber or a syringe at the end of a fluid conduit.
  • Other embodiments may comprise one or more suction/vacuum ports on any other suitable
  • a fluid delivery port 316b may be provided.
  • the fluid delivery port may be coupled with a pump or high pressure fluid.
  • the port may be perpetually open such that fluid may be delivered therethrough upon actuation of a pump or fluid pressure system.
  • the port may be perpetually open such that fluid may be delivered therethrough upon actuation of a pump or fluid pressure system.
  • 1150 may be closed and selectively opened to deliver fluid therethrough.
  • Other embodiments may comprise one or more fluid ports on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft.
  • Fluid ports that may be useful may comprise channels within the TDM, polymer lines, hoses, etc. Fluids that may emanate from the outlet may comprise ionic fluids such as saline, medicines (including but not
  • 1155 limited to antibiotics, anesthetics, antineoplastic agents, bacteriostatic agents, etc.), non-ionic fluids, and or gasses (including but not limited to nitrogen, argon, air, etc.).
  • gasses including but not limited to nitrogen, argon, air, etc.
  • fluids may be under higher pressures or sprayed. It should be understood that although these elements (316b & 317b) are not depicted in every one of the other figures, any of the embodiments described herein may include one or more such elements.
  • a vibration means 370b may be positioned in the handle.
  • Other embodiments may comprise one or more vibration means on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft.
  • suitable vibration means may include piezoelectric materials, ultrasonic motors with stators, piezoelectric actuators, vibration motor such as an off-center weight mounted on a
  • Some vibration means may be configured to emit ultrasound in the 20-40kHz range.
  • vibration means may include electromagnet drivers with a frequency of operation in the range of 150-400Hz.
  • one or more vibration means may be used to provide additional forces which may facilitate passage of the TDM.
  • one or more vibration means may be used to reduce debris on the electrosurgical or other
  • a vibration means may be directly or
  • 318b represents an antenna, such as an RFID TAG.
  • antenna 318b comprises an RFID tag
  • the RFID tag may comprise an RFID transponder.
  • the RFID tag may comprise a passive tag.
  • antenna 318b is not depicted in every one of the other figures, however, any of the embodiments described herein may comprise one or more such elements.
  • Other embodiments may comprise one or more antennas on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft.
  • an RFID transponder or another antenna may comprise a microchip, such as a
  • the tag may measure less than a few millimeters.
  • a reader may generate an alternating electromagnetic field which activates the RFID transponder/antenna and data may be sent via frequency modulation.
  • the position of the RFID tag/antenna may be determined by an alternating electromagnetic field in the ultra-high frequency range. The position may be related 1185 to a 3 dimensional mapping of the subject.
  • the reader may generate an alternating electromagnetic field.
  • the alternating electromagnetic field may be in the shortwave (13.56MHz) or UHF (865-869MHz) frequency.
  • tip 301 may be attached to a robotic arm. In some embodiments, tip 301 and portion of shaft 302 may be attached to a robotic arm. In some embodiments tip 301
  • the robotic arm may comprise one or more motors such as a screw-drive motor, gear motor, hydraulic motors, etc.
  • the robotic arm system may comprise worm gearheads, video cameras, motor control circuits, monitors, remote control devices, illumination sources, tactile interface, etc.
  • FIG. 3c depicts an embodiment of the target-tissue-impedance-matched-microwave-based emission system (TTIMMES) previously depicted in FIG. 3a.
  • TTIMMES target-tissue-impedance-matched-microwave-based emission system
  • This depicted embodiment includes energy window 307, which is configured to comprise a bundle of microwave antennae 322a further comprising singular antennae, such as 320 and 321.
  • Coaxial cable bundle 322 carries gigahertz microwave energy derived from a super high frequency (SHF) generator, into
  • SHF super high frequency
  • a flat microwave emitter may be placed in energy window 307.
  • flat microwave emission devices are comprised of a "microstrip" in which an antenna is printed on a circuit board.
  • the circuitboard may be coated with polytetrafluroethylene, and may be seated on an alumina substrate.
  • a controllable solid state source N5183A MXG Microwave Analog Signal Generator from Agilent TechnologiesTM
  • SHF super-high frequency
  • an "energy window” may comprise a variety of other energy emitting devices, 1210 including radiofrequency, microwave, filament, light, intense pulsed light, LASER, thermal, and ultrasonic.
  • a second energy window 308 may also be included in some embodiments, and may comprise yet another microwave or another variety of energy emitting device.
  • the energy window may also comprise one or more LASERS that may also be used through the fiberoptic and may be controlled at the electromagnetic energy 1215 source by a footswitch.
  • the planar tissue-altering-window/zone may be an optical window that allows laser light to exit the shaft and irradiate nearby target tissue.
  • a light delivery means which can be a hollow waveguide or single or multiple optical fibers (such as metal coated plastic manufactured by Polymicro TechnologiesTM, Inc. of Phoenix, Ariz.) may be contained in an external conduit.
  • the external conduit may 1220 comprise, for example an articulating arm as is commonly used in surgical laser systems.
  • Additional control wires and power may be delivered to the handpiece via the external conduit.
  • foot-pedal control from an electromagnetic energy radiation source or control interface, dial, or panel will likely be less cumbersome for the surgeon and reduce the expense of handpiece finger-control manufacture.
  • Some embodiments may use an energy window comprising Germanium, which may allow for egress of laser light and collection of data by thermal sensors, and such energy window may be of varying size.
  • a multiplicity of optical fibers may terminate at specific or random places within the energy window. Such bare or coated fiberoptic termini may protrude from, be flush with, or be recessed into, other materials comprising the energy window.
  • bare or coated fiberoptic termini may protrude from, be flush with or be recessed into other materials comprising the energy window.
  • bare fiberoptics comprising ethylene oxide sterilizable may be seated in a thermally nonconductive background, preferably at uniform 90 degree angles, but variable angles between 0 and 180 degrees may also be efficacious.
  • the preferred light delivery means may depend on the wavelength of the laser
  • Infrared light emitted by the heated tissue can also be collected through the window and sensed by an infrared detector to measure the tissue temperature.
  • reliable sources include standard operating room units, such as the Encore Ultrapulse® from Lumenis Corp. of Santa Clara, Calif., which is capable of providing continuous C0 2 laser energy outputs of 2-22mJoules at 1-60 Watts. Older models of the Coherent UltrapulseTM may also be
  • a hollow section of shaft may act as a waveguide or may contain a metal-coated plastic fiberoptic or waveguide to allow laser light to pass through and exit from window near tip.
  • the window may allow egress for laser light delivered to apparatus.
  • Lasers may include both pulsed and continuous wave lasers, such as C0 2 ,
  • the beam diameter may be changed as desired, as those skilled in the art will appreciate. However, this list is not intended to be self-limiting and other wavelength lasers may be used.
  • Some embodiments of the energy window may comprise an intense, pulsed, non-coherent, non-LASER, such as a filtered flashlamp that emits a broadband of visible light.
  • the flashlamp such as a filtered flashlamp that emits a broadband of visible light.
  • a flashlamp may emit optical and thermal radiation that can directly exit the energy window, or may be reflected off a reflector to exit through the window.
  • a reflector may have a parabolic shape to
  • the window 1255 effectively collect radiation emitted away from the window, which may be made of a wide variety of glass that transmits optical, near infrared, and infrared light (e.g., quartz, fused silica and germanium.) Emission spectra may be filtered to achieve the desired effects. Thermal emissions or visible radiation absorption may locally heat the dermis to alter collagen. Thermal sensors may also be used to control or reduce overheating. In order to eliminate excessive
  • the flashlamp and reflector may be
  • the handle can be an alternative location for the flashlamp so that emitted radiation may be reflected by a mirror through the window/zone.
  • direct piezoelectric versions of the energy window may impart
  • Energy output for piezoelectric window/zones may typically range from about 1-30 J; in an
  • an energy output range of about 1-6 J may occur in a surgical device moving about 1 cm/second.
  • temperature and impedance sensors may provide
  • intraoperative real-time data can modulate energy input into the piezoelectric, which may be energized by one or more conductive elements in the shaft in further connection with the control unit and/or power supply.
  • the 1275 embodiment may allow thermal energy to escape from within the shaft, and wherein the tip can be integral or a continuation of shaft made of similar metal or materials.
  • the tip may also be constructed of materials that are both electrically non-conductive and of low thermal
  • an antenna such as a microwave antenna
  • a filament may be fixedly attached to the shaft.
  • the hot filament may emit optical and thermal radiation that can directly exit the energy window or be reflected off a reflector to also exit through window.
  • the reflector may have a parabolic shape to effectively
  • a hot filament can be a tungsten carbide filament similar to those used in high power light bulbs. The wavelength may be adjusted and controlled by adjusting the filament temperature/current.
  • the window may be selected from a wide variety of glass that transmits optical, near infrared and infrared light (e.g., quartz, fused silica and germanium.) The tissue
  • 1290 penetration depth may depend on the wavelength of the light (e.g., 1 ⁇ may penetrate through about 10 mm, 10 ⁇ may penetrate through about 0.02 mm).
  • the broad emission spectrum from the hot filament may be filtered to achieve the desired tissue effect.
  • thermal sensors connected to the control unit by electrical wire may be used to monitor the temperature of tissue that is in contact with the shaft. In order to eliminate
  • the heating element and/or reflector may be thermally isolated by low thermal conductivity materials.
  • the heating element may be isolated by reducing contact with the shaft, whereas the reflector may have an isolating layer where it attaches to the shaft.
  • cold nitrogen gas may be injected through tube and pumped out through the hollow shaft to cool the tip and shaft.
  • the hot filament may be placed in the handle while emitted optical and thermal radiation is reflected off a mirror through the window.
  • An alternative embodiment may allow for tissue heating to be achieved by direct contact with a hot surface where electric current flowing through wires heats a resistive load made of single or multiple elements to a user selected temperature.
  • the resistive load could be a thin film resistor and the film
  • thermal sensors placed close to the heating element may be used to measure temperatures, which may be sent to a control unit to control the current through the resistive load.
  • Cold gas or liquid(s) can be injected through tubes and pumped out through the shaft.
  • the heating element could be the hot side of a Peltier thermoelectric cooler
  • heat may be derived via magnetic or frictional methods to bring about similar tissue alterations.
  • the lysing elements 1315 delivered by or otherwise at the lysing elements may be sufficient to at least partially induce fibrosis within a target region as the tissue is separated.
  • the energy at the lysing elements may be increased beyond what would otherwise be needed
  • energy 1320 just to separate tissue into planes.
  • one may be able to induce target tissue fibrosis by using only the requisite energy needed to separate tissue.
  • energy may be increased (such as an increase of 5% to 500%) to increase the probability of inducing target tissue fibrosis without the use of an energy window.
  • energy may be increased (such as an increase of 5% to 150%) to increase the
  • energy may be increased (such as an increase of 10% to 30%) to increase the probability of target tissue fibrosis without the use of an energy window.
  • Some embodiments may comprise a tip comprising a plurality of protrusions and/or at least one lysing element positioned between each of the protrusions and/or an energy window
  • the energy window may comprise an array of impedance-matched-microwave emitting antennae.
  • Another embodiment may comprise a
  • the senor comprises at least one of a thermal sensor, a photoelectric sensor, a photo-optic sensor, a camera, and a MEMS sensor.
  • the at least one lysing element may comprise at least one lysing segment.
  • the electrical wiring for the TDM comprises a
  • the two-conductor cable 4120 is comprised of RF conductor one 4130 and RF
  • RF conductor one 4130 extends from RF pin one 4110, positioned in the connector 4100, to the Switch RF pin 4150 of the SPDT switch 4145 which may be positioned in the handle 4140.
  • the COAG electrode conductor 4176 positioned in the shaft 4175 extends from the COAG electrode 4185 may be positioned in the tip 4180, to the COAG electrode pin 4155 of the SPDT switch 4145.
  • the RF conductor two 4135 starting in the connector 4100, extends from RF pin two 4115 that may be positioned in the connector 4100 or within another connector plugged into the electrosurgical generator, to the return electrode 4195 positioned in the tip 4180 or on the shaft 4175.
  • the SPDT switch 4145 can be manipulated between two
  • the switch RF pin 4150 may be electrically short circuited to the COAG electrode pin 4155. In the other switch position, the RF pin 4150 may be electrically short circuited to the CUT electrode pin 4160.
  • This embodiment requires the use of a foot switch (such as the Valley Lab Bipolar Footswitch, E6008) in conjunction with an electrosurgical generator (ESU) to activate/deactivate the RF energy delivered to the TDM.
  • ESU electrosurgical generator
  • the TDM may be utilized as a bipolar device with a selectable electrode
  • the surface area that comprises the return electrode 4195 which makes contact with the electrically conductive material is optimally chosen to minimize 1370 the current density with the objective of minimizing the heating on the surface of the return electrode 4195.
  • the conductor cable 4120 comprises more than two conductors to accommodate other attributes of the device.
  • the SPDT switch 4145 may be positioned on the conductor cabling 4120 between the connector 4100 and the handle 4140; in such embodiments the electrode conductors 4176 and 4177 leading to the
  • electrodes 4185 and 4190 may extend through or around the shaft 4175 and handle 4140 and may comprise at least part of conductor cabling 4120.
  • the shaft 4175 may contain more than 3 conductors.
  • each conductor within the conductor cable 4120 may be contained in its own cabling.
  • the switch 4145 may have more than 2 positions.
  • Some embodiments may comprise a tip further comprising a plurality of protrusions and/or at least one lysing element positioned between each of the protrusions and/or a tip positioned at a distal end of the shaft, wherein the tip comprises a plurality of protrusions and at least one lysing element positioned between at least two adjacent protrusions in the plurality of protrusions.
  • a lysing element may be configured to emit electromagnetic
  • electromagnetic energy may comprise a bipolar radiofrequency electrosurgical current.
  • FIG. 5a is an upper plan view illustrating the protrusions and lysing elements of an embodiment of a tissue dissector and modifier, wherein some of the protrusions and lysing elements are oriented in a non-axial direction and the non-axial protrusions do not extend
  • the tip may measure about 1 cm in width and about 1-2 mm in thickness. Sizes of about one-fifth to about five times these dimensions may also have possible uses.
  • the non-axial protrusions 551a of tip 501 a do not 1395 extend beyond the width of the distal shaft 502a, which leads to handle 503a.
  • non-axial protrusions 551 a extend in a direction that is at least substantially perpendicular to the direction in which axial protrusions 504a extend. More particularly, there are two sets of non-axial protrusions 551 a (one depicted on the right side and one on the left side of the embodiment of FIG. 5a). Both sets of non-axial protrusions 551a extend in directions 1400 that are at least substantially perpendicular to the direction in which axial protrusions 504a
  • the two sets of non-axial protrusions 551a extend in directions that are at least substantially opposite from one another.
  • axial protrusions 504a may extend at least substantially along a 1405 longitudinal axis of the shaft, as described above, and non-axial protrusions 551 a may extend at an angle of between zero degrees and 30 degrees of a normal to the direction in which the axial protrusions 504a extend. It is contemplated that it may desirable for some implementations and embodiments to provide non-axial tips extending in a direction or directions falling within this range in order to, for example, allow a surgeon to effectively perform both a to and fro, and a
  • the tip can be a separate piece that is secured to the shaft by a variety of methods such as a snap mechanism, mating grooves, plastic sonic welding, etc.
  • the tip can be integral or a continuation of a shaft made of similar metal or materials.
  • the tip may also be constructed of
  • the tip may be constructed of a support matrix of an insulating material (e.g., ceramic or glass material such as alumina, zirconia).
  • an insulating material e.g., ceramic or glass material such as alumina, zirconia.
  • the 1420 previously described in other embodiments may connect to electrically conductive elements to bring RF electrosurgical energy from an electrosurgical generator down the shaft 502a to electrically conductive lysing elements 552a mounted in the recessions in between the protrusions 551a.
  • the protrusions may comprise bulbous protrusions.
  • the tip shown in this embodiment has two relative protrusions and three relative recessions
  • the tip shown also has fourteen protrusions pointing in non-axial directions as well as fourteen relative recessions pointing in non-axial directions.
  • the tip may have one or more non-axial protrusions and one or more non-axial relative recessions.
  • the tip may have between 3 and 100 non-axial protrusions and relative
  • the tip 501a may alternatively be made partially or completely of concentrically laminated or annealed-in wafer layers of materials that may include plastics, silicon, glass, glass/ceramics, cermets or ceramics. Lysing elements 552a may also be made partially or completely of a cermet material. Alternatively, in a further embodiment the tip may be constructed of insulation covered metals or electroconductive materials. The lysing
  • elements may be located at the termini of conductive elements.
  • tip 501a which terminates in protrusions such as 504a and 551a may be made of materials that are both electrically non-conductive and of low thermal conductivity such as porcelain, epoxies, ceramics, glass-ceramics, plastics, or varieties of polytetrafiuoroethyiene.
  • the tip may be made from metals or electroconductive
  • conductive tissue lysing element(s) 552a may have any geometric shape including a thin cylindrical wire, and may be positioned within the relative recessions of the tip.
  • the electrically conductive lysing element can be in the shape of a plate or plane or wire and made of any metal or alloy that does not melt under operating conditions or give off toxic residua.
  • materials may include but are not limited to steel, nickel, alloys, palladium, gold, tungsten, silver, copper, and platinum. Metals may become oxidized thus impeding electrical flow and function.
  • the shaft may be flat, rectangular or geometric in cross-section and/or substantially flattened. In some embodiments, smoothing of the edges of the shaft may reduce friction on the tissues surrounding the entrance wound. In some further embodiments,
  • the shaft may be made of metal or plastic or other material with a completely occupied or hollow interior that can contain insulated wires, electrical conductors, fluid/gas pumping or suctioning conduits, fiber-optics, or insulation.
  • shaft plastics such as polytetrafiuoroethy!ene, may act as insulation about wire or electrically conductive elements.
  • the shaft may act as insulation about wire or electrically conductive elements.
  • the shaft may act as insulation about wire or electrically conductive elements.
  • 1455 alternatively be made partially or completely of concentrically laminated or annealed-in wafer layers of materials that may include plastics, silicon, glass, glass/ceramics, ceramics carbon, graphite, and/or graphite-fiberglass composites.
  • FIG. 5a the depicted view of an embodiment of a TDM with an alternative energy window 507a on the upper side of the device may be configured to hold an ultrasound energy emitter. It
  • the term "energy window” is intended to encompass what is referred to as a planar-tissue-altering-window/zone in U.S. Patent No. 7,494,488 and, as described herein, need not contain a ultrasonic energy emitter in all embodiments. Additionally, the "energy window” may comprise a variety of other energy emitting devices, including but not limited to radiofrequency, microwave, light, intense pulsed light, LASER, and thermal. Certain
  • components of the energy window such as the electro-conductive components of the energy window, could comprise a cermet.
  • a second energy window 508a may also be included in some embodiments, and may comprise yet another ultrasonic energy emitter or another variety of energy emitting device.
  • energy windows 507a and/or 508a may only be substantially planar, or may take on other cross-sectional shapes that may correspond with a
  • energy window 507a is adjacent to protrusions 504a and 551 a, however other embodiments are contemplated in which an energy window may be positioned elsewhere on the shaft 502a or tip 501 a of the wand, and still be considered adjacent to protrusions 504a or 551a. For example, in an embodiment lacking
  • energy window 508a 1475 energy window 507a, but still comprising energy window 508a, energy window 508a would still be considered adjacent to protrusions 504a and 551a. However, if an energy window was placed on handle 503a, such an energy window would not be considered adjacent to
  • protrusions 504a or 551a are protrusions 504a or 551a.
  • one or more sensors such as for example sensors 510a and 514a
  • the sensors 510a and 514a may comprise any of the sensors described in the specification herein. Other embodiments may comprise one or more sensors on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft. Sensors that may be useful include thermal sensors, photoelectric or photo optic sensors, cameras, etc. In some embodiments,
  • one or more sensors may be used to monitor the local post passage electrical impedance or thermal conditions that may exist near the distal tip of the shaft or on the tip.
  • embodiments may also comprise one or more sensors incorporating MEMS (Micro Electro- Mechanical Systems) technology, such as MEMS gyroscopes, accelerometers, and the like.
  • MEMS Micro Electro- Mechanical Systems
  • sensors may be positioned at any number of locations on the TDM, including within the
  • sensor 514a may comprise fiberoptic elements.
  • the sensor can be configured to sense a temperature of tissue adjacent to the apparatus during one or methods described herein.
  • the temperature sensor may alternatively be configured or sense a temperature of one or more fluids adjacent to the apparatus such as for example tissue fluids and/or fluids introduced by the surgeon.
  • Temperature and impedance values may be tracked on a display screen or directly linked to a microprocessor capable of signaling control electronics to alter the energy delivered to the tip when preset values are approached or exceeded.
  • Typical instrumentation paths are widely known, such as thermal sensing thermistors, and may feed to analog amplifiers which, in turn, feed analog digital converters leading to a microprocessor.
  • 1500 external ultrasound measurements may also be taken during a procedure with the TDM.
  • Temperature sensors that may be useful include thermal sensors, photoelectric or photo optic sensors, cameras, etc. Temperature sensors that may be useful in connection with embodiments disclosed herein include, but are not limited to, resistance temperature sensors, such as carbon resistors, film thermometers, wire-wound thermometers, or coil elements. Some embodiments
  • thermocouples may comprise thermocouples, pyrometers, or non-contact temperature sensors, such as total radiation or photoelectric sensors.
  • one or more electromagnetic delivery elements 515a may be positioned on tip or shaft.
  • Other embodiments may comprise one or more electromagnetic delivery elements on any other suitable location on the TDM, including but not limited to on the
  • Electromagnetic delivery elements that may be useful include: LEDs, LASERS, fiberoptics, filaments, photoelectric materials, infrared emitters, etc.
  • surgeons may implement the use of a fanning motion which may comprise a 1515 'windshield wiper' motion.
  • FIG. 5b is an upper plan view illustrating the protrusions and lysing elements of an alternative embodiment of a tissue dissector and modifier, wherein some of the protrusions and lysing elements are oriented in a non-axial direction and some of the non-axial protrusions extend beyond the width of the distal shaft.
  • 501 b represents the tip
  • 515b represents an axially aligned protrusion
  • 551 b represents a non-axially aligned protrusion
  • 552b represents a non-axially aligned relative recession
  • 507b represents a first energy window
  • 508b represents a second energy window
  • 510b and 514b represent sensor elements
  • FIG. 5b is an upper plan view illustrating the protrusions and lysing elements of an
  • 501 b represents the tip area which lies adjacent to shaft area 502b which is connected to handle area 503b; 504b
  • 1530 represents an axially aligned protrusion
  • 551 b represents a non-axially aligned protrusion
  • 552b represents a non-axially aligned relative recession
  • 507b represents a first energy window
  • 508b represents a second energy window
  • 510b and 514b represent sensor elements similar to those previously discussed in other embodiments
  • 515b represents an electromagnetic radiation delivery element similar to those previously discussed in other embodiments.
  • FIG. 5c is a lower plan view of the embodiment of FIG. 5a illustrating the protrusions and lysing elements of a tissue dissector and modifier, wherein some of the protrusions and lysing elements are oriented in a non-axial direction and the non-axial protrusions do not extend beyond the width of the distal shaft.
  • 501 a represents the tip area which lies adjacent to shaft area 502a which is connected to handle area 503a; 516a represents
  • antenna 518a represents an antenna, such as an RFID TAG.
  • antenna 518a comprises an RFID tag
  • the RFID tag may comprise a RFID transponder.
  • the RFID tag may comprise a passive tag. It should be understood that although antenna 518a is not depicted in every one of the other figures, any of the embodiments described herein may include one or more such
  • Other embodiments may comprise one or more antennas on any other suitable
  • an RFID transponder or other antenna may comprise a microchip such as a microchip having a rewritable memory.
  • the tag is millimeter sized.
  • a reader generates an alternating electromagnetic field
  • the position of the antenna/RFID tag is determined by an alternating
  • the position may be related to a 3 dimensional mapping of the subject.
  • the reader may generate an alternating electromagnetic field.
  • the alternating electromagnetic field may be in 1555 the shortwave (13.56MHz) or UHF (865-869MHz) frequency.
  • a suction/vacuum port 517a may be provided on or about the tip or distal shaft.
  • the port may be fluidly coupled with a vacuum; the vacuum may comprise a pump or a negative pressure chamber or a syringe at the end of a fluid conduit.
  • Other embodiments may comprise one or more suction/vacuum ports on any other suitable location on the TDM,
  • a fluid delivery port 516a may be provided.
  • the fluid delivery port may be coupled with a pump or high pressure fluid.
  • the port may be perpetually open such that fluid may be delivered therethrough upon actuation of a pump or fluid pressure system.
  • the port may be closed and selectively
  • Fluid ports 1565 opened to deliver fluid therethrough may comprise one or more fluid ports on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft.
  • Fluid ports that may be useful include channels within the TDM, polymer lines, etc. Fluids that may emanate from the port may include ionic fluids such as saline, medicines (including but not limited to antibiotics, anesthetics, antineoplastic
  • tip 501a may be attached to a robotic arm. In some embodiments tip
  • tip 501a and portion of shaft 502a may be attached to a robotic arm.
  • tip 501a and a portion of shaft 502a and or a portion of handle 503a may be attached to a robotic arm.
  • FIG. 5d is a lower plan view of the embodiment of FIG. 5b illustrating the protrusions and 1580 lysing elements of a tissue dissector and modifier, wherein some of the protrusions and lysing elements are oriented in one or more non-axial directions and at least some of the non-axial protrusions extend beyond the width of the distal shaft.
  • tip area 501 b represents the tip area which lies adjacent to shaft area 502b which is connected to handle area 503b; this particular embodiment also comprises fluid port 516b; suction port 517b; 1585 518b represents an antenna, such as an RFID TAG.
  • the antenna comprises an RFID tag
  • the RFID tag may comprise a RFID transponder.
  • the RFID tag may comprise a passive tag. It should be understood that although antenna 518b is not depicted in every one of the other figures, any of the embodiments described herein may include one or more such locations.
  • the tips depicted in Figures 5a,b,c,d are contemplated to be able to be used with any of the embodiments discussed herein. Said tips are not intended to be restricted to symmetry and/or pattern and/or dimension. In other embodiments said tips may be asymmetrical or lacking protrusions and/or lysing elements on one side or another.
  • the tissue dissector and modifier may have an asymmetrical tip area.
  • some embodiments may comprise a plurality of non-axial protrusions along the left or right side of the tip.
  • the right side of the tip may lack any protrusions and thus also lacks recessions.
  • the right side of the tip may comprise an at least substantially flat surface area.
  • the surgical system may comprise a plurality of modular tips that
  • 1600 may further comprise a first plurality of protrusions and/or a second plurality of protrusions, wherein the first plurality of protrusions is positioned to at least substantially extend in a first direction when the modular tip is coupled with the shaft, and wherein the second plurality of protrusions is positioned to at least substantially extend in a second direction distinct from the first direction when the modular tip is coupled with the shaft.
  • a tip further comprising a first plurality of protrusions and a second plurality of protrusions
  • first plurality of protrusions is positioned to at least substantially extend in a first direction
  • second plurality of protrusions is positioned to at least substantially extend in a second direction distinct from the first direction and/or at least one lysing element positioned between at least two adjacent protrusions in the first plurality of protrusions and/or at
  • the first direction may be at least substantially perpendicular to the second direction. In other embodiments, the first direction may extend at an acute angle relative to the second direction. In some embodiments, at least one lysing element may comprise at least one lysing segment.
  • Said modular TD and/or TDM are not intended to be restricted to symmetry and/or pattern and/or dimension.
  • said modular TD and/or TDM may be asymmetrical or lacking protrusions and/or lysing elements on one side or another.
  • FIG. 6 depicts an embodiment of a modular TD 600 comprising a tip 601 , a electrosurgical 'pencil' shaft 602, and an electrosurgical 'pencil' handle 603.
  • Rocker switch 603.2 located on or
  • tip 601 is modular in that it is removable from shaft 602. More particularly, tip 601 comprises a means for removably coupling the tip with a shaft at 668. In the depicted embodiment, this coupling means comprises a tip plug 668. In some embodiments, tip plug 668 may be threaded
  • the coupling means may comprise a recess configured to receive a plug formed on the shaft.
  • the coupling means may comprise a snap-fit coupling, a friction fit coupling, a bayonet clip, etc.
  • tip plug 668 is configured to be received within a corresponding
  • elements within tip plug 668 and/or recess 669 may be electrically connected with electrical elements within shaft 602 and/or handle 603 which are in turn connected with switch 603.2 and/or conduit 611.2.
  • tip plug 668 may be configured to electrically couple tip 601 with shaft 602. In this manner, in embodiments comprising, for example, lysing elements, electricity from a power
  • 1635 source may be transmitted through the coupling between plug 668 and recess 669 to allow for energizing the lysing elements.
  • tip 601 may be disposable as well, such that a surgeon can place an appropriate tip on the shaft and remove and dispose of the tip after surgery.
  • a plurality of different tips may be provided, each of which may be disposable, or
  • 1640 may be configured for sterilization and re-use, and an appropriate tip may be selected as
  • tip 601 comprises a plurality of protrusions 604, some of which are non-axial, and a plurality of recessions 605 positioned therebetween, as described above.
  • a tip comprising only axial protrusions may be swapped for tip 601 as
  • the plug connection may be made tighter by things such as putting screw threads and/or a hole for a twisted wire and/or a jacket and/or a form-fit and/or a spear prong, etc., in one or more portions of the receiving or the giving portions of the plug; such things may prevent rotation of the tip in/on certain devices.
  • Some embodiments may comprise a removable tip for a surgical tool, which may further comprise a plurality of protrusions and/or at least one recessed region positioned between at least a subset of the adjacent protrusions and/or at least one lysing element positioned in at least one of the recessed regions and/or a means for removably coupling the tip with a shaft of a surgical tool.
  • surgical tool which may comprise an electrically conductive portion configured to electrically couple with a corresponding electrically conductive portion of the surgical tool.
  • the electrically conductive portion may be configured to deliver electrosurgical current from the surgical tool to the at least one lysing element.
  • the surgical tool may comprise an endoscope.
  • a surgical system may comprise a surgical tool comprising a shaft and/or a plurality of modular tips, wherein at least a subset of the plurality of modular tips is distinct from at least a subset of the other modular tips in the plurality of modular tips to provide for distinct functions for particular surgical procedures, and wherein each of the plurality of modular tips may further comprise: a plurality of
  • System 700 may comprise a tissue dissecting and modifying wand (TDM) 701.
  • TDM 1670 701 may comprise a tissue dissecting and modifying wand (TDM) that may, as described
  • TDM 701 may be coupled with one or more robotic surgery components, such as a surgical arm.
  • TDM 701 may comprise a shaft, a tip, and/or a handle, as described 1675 elsewhere in this disclosure.
  • TDM 701 may be selectively coupled to a robotic arm such that the TDM 701 can either be used by hand, or coupled with one or more robotic surgery components to allow a surgeon to perform a surgical procedure with the TDM 701 remotely and/or indirectly.
  • the TDM may be configured to be integrally coupled with, or otherwise non-selectively coupled with, one or more robotic surgery 1680 components. In such embodiments, it may not be necessary to configure the TDM 701 with a handle and/or shaft.
  • the TDM 701 may comprise only a tip.
  • the robotic surgery system 700 may comprise one or more motors, such as a screw-drive motor, gear motor, hydraulic motors, etc.
  • the motors such as a screw-drive motor, gear motor, hydraulic motors, etc.
  • TDM 700 may comprise worm gearheads, video cameras, motor control circuits, monitors, remote control devices, illumination sources, tactile interface, etc.
  • TDM 700 comprises a TDM tip 701a that is positioned at the end of a robotic arm.
  • This robotic arm comprises a plurality of arm segments 773 with corresponding joints 776 positioned therebetween.
  • a primary joint 777 may be positioned to
  • a stand 781 may also be provided to support the various robotic arms.
  • stand 781 may also be configured to support a monitor 779 and/or other display,
  • control element 778 may comprise a hand control toggle 778.
  • control element 778 may comprise a keyboard, mouse, touchscreen display, virtual reality system, control pad, or the like.
  • Monitor 779 and/or control element 778 may be communicatively coupled with a central processing unit 780.
  • Central processing unit 780 may comprise, for example, one or more microprocessors
  • central processing unit 780 may comprise a general-purpose computer. Central processing unit 780 may further comprise a machine-readable storage device, such as non-volatile memory, static RAM, dynamic RAM,
  • FIG. 7b illustrates an alternative embodiment of a robotic arm 772 that may be used with system 700.
  • Robotic arm 772 comprises an endoscopic snake-like robotic arm 772 and also comprises a TDM 701 b positioned at its distal end.
  • TDM 701 b positioned at its distal end.
  • TDM 701 b may be selectively coupled to robotic arm 772 or, alternatively, may be integrally or otherwise non-selectively coupled to robotic arm 772. Further details regarding robotic surgery components that may be useful in connection with the various embodiments disclosed herein may be found in the following U.S. Patent Nos., each of which is hereby incorporated by reference in its entirety:. 4,259,876 titled Mechanical Arm, 4,221 ,997 titled Articulated Robot
  • any of the embodiments of TDM discussed herein including, but not limited to, the embodiments discussed with Figs 1a-g, Figs 2a-c, Figs 3a-c, Fig 4, Figs 5a,b,c,d, etc. may be used in conjunction with one or more of the robotic surgery elements disclosed in connection
  • Some embodiments may comprise a tip further comprising a plurality of protrusions and/or at least one lysing element positioned between each of the protrusions and/or a tip positioned at a distal end of the shaft, wherein the tip comprises a plurality of protrusions and at least one lysing element positioned between at least two adjacent protrusions in the plurality of
  • Some embodiments may comprise a robotic arm configured to allow a surgeon to operate using the apparatus indirectly, wherein the tip is positioned at a distal end of the robotic arm.
  • a robotic surgery system may be coupled with the robotic arm.
  • the robotic surgery system may comprise a control element.
  • the control element may comprise at least one of a hand control toggle, a
  • keyboard a mouse, a touchscreen display, a virtual reality system, and a control pad.
  • FIG. 8 depicts an embodiment of a modular TD 800 comprising a tip 801 , a flexible shaft 802, and an endoscope handle 803.
  • Tip 801 is modular in that it is removable from flexible shaft 802. More particularly, tip 801 comprises a means for removably coupling the tip with a shaft at 868. In the depicted embodiment, this coupling means comprises a tip plug 868. In 1740 some embodiments, tip plug 868 may be threaded to facilitate a secure coupling between modular tip 801 and shaft 802. However, in other embodiments, the coupling means may comprise a recess configured to receive a plug formed on the shaft. In still other embodiments, the coupling means may comprise a snap-fit coupling, a friction fit coupling, a bayonet clip, etc. In the depicted embodiment, tip plug 868 is configured to be received within a corresponding
  • tip plug 868 may be configured to electrically couple tip 801 with shaft 802. In this manner, in embodiments comprising, for example, lysing elements, electricity from a power source may be transmitted through the coupling between plug 868 and recess 869 to allow for energizing the lysing elements. Other embodiments may be configured to transfer additional electricity, data, or materials through
  • a signal from such sensor(s) may be transmitted through shaft 802 by way of the coupling means 868.
  • tip 801 may be disposable as well, such that a surgeon can place an appropriate tip on the shaft and remove and dispose of the tip after surgery.
  • a plurality of different tips may be provided, each of which may be disposable, or may be configured for sterilization and re-use, and an appropriate tip may be selected as needed for a particular surgery.
  • tip 801 comprises a plurality of protrusions 804, some of which are non-axial, and a plurality of recessions 805 positioned therebetween, as described above. 1760
  • a tip comprising only axial protrusions may be swapped for tip 801 as desired to suit a particular surgical procedure.
  • a tip comprising a plurality of protrusions having one or more lysing elements positioned between the protrusions;
  • the energy window positioned on an upper side of the apparatus, wherein the energy window comprises a thermochromic media, and wherein the thermochromic media is configured to absorb electromagnetic radiation energy and emit heat energy from the energy window. 1770
  • the energy window may comprise a LASER that is configured to deliver energy to the thermochromic media such that the thermochromic media can then emit heat energy from the energy window.
  • a tip comprising a plurality of protrusions having one or more lysing elements positioned between the protrusions;
  • an energy window positioned on an upper side of the apparatus, wherein the energy window comprises a microwave antennae, and wherein the microwave antennae is configured 1780 to convert electromagnetic energy and emit microwave energy from the energy window.
  • a tip comprising a plurality of protrusions having one or more lysing elements positioned 1785 between the protrusions;
  • an energy window positioned on an upper side of the apparatus, wherein the energy window comprises an target-tissue-impedance-matched-microwave-based energy window.
  • Any methods disclosed herein comprise one or more steps or actions for performing the described method.
  • the method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the
  • any reference to "one embodiment,” “an embodiment,” or “the embodiment” means that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment.
  • the quoted phrases, or variations thereof, as recited throughout this specification are not necessarily all referring to the

Abstract

Apparatus and systems for tissue dissection and modification are disclosed herein. The TD and/or TDM may comprise a modular tip having a plurality of protrusions with lysing segments positioned between the protrusions to dissect and/or modify tissue. The TDM may also comprise an energy window positioned on top of the TDM that is configured to deliver energy via thermochromic and/or impedance matched microwave means to modify tissues.

Description

APPARATUS & SYSTEMS FOR TISSUE DISSECTION & MODIFICATION
BRIEF DESCRIPTION OF THE DRAWINGS
The written disclosure herein describes illustrative embodiments that are non-limiting and non-exhaustive. Reference is made to certain of such illustrative embodiments that are depicted in the figures, in which:
FIG. 1 a is a perspective view of an embodiment of a tissue dissector and modifier with an energy window on the upper side of the device.
FIG. 1 b is a side elevation view of the embodiment previously depicted in FIG. 1a.
FIG. 1 c is a front elevation view of the embodiment previously depicted in FIG. 1a.
FIG. 1 d is a front elevation view illustrating the protrusions and lysing segment of an alternative embodiment of a tissue dissector and modifier wherein the lysing segment connecting the two protrusions is centered substantially midway between the upper and lower portions of the protrusions.
FIG. 1 e is a front elevation view illustrating the protrusions and lysing segment of an alternative embodiment of a tissue dissector and modifier, wherein the lysing segment connecting the two protrusions is positioned above the midline between the upper and lower portions of the protrusions.
FIG. 1f is a front elevation view illustrating the protrusions and lysing segment of an alternative embodiment of a tissue dissector and modifier, wherein the lysing segment connecting the two protrusions is positioned below the midline between the upper and lower portions of the protrusions.
FIG. 1g is a cross-sectional view of an embodiment of a TDM illustrating some examples of some of the canals that may be used with the device.
FIG. 2a is a perspective view of an embodiment of a tissue dissector and modifier with a thermochromic-based energy window on the upper side of the device.
FIG. 2b is a side elevation view of the embodiment previously depicted in FIG. 2a.
FIG. 2c is a front elevation view of some thermochromic-based energy window components of an embodiment previously depicted in FIG. 2a.
FIG. 3a is a perspective view of an embodiment of a tissue dissector and modifier with a target-tissue-impedance-matched-microwave-based energy window on the upper side of the device.
FIG. 3b is a side elevation view of the embodiment previously depicted in FIG. 3a.
FIG. 3c is a front elevation view of some target-tissue-impedance-matched-microwave- based energy window components of an embodiment previously depicted in FIG. 3a.
FIG. 4 is a wiring diagram of a bipolar embodiment of the TDM.
FIG. 5a is an upper plan view illustrating the protrusions and lysing elements of an embodiment of a tissue dissector and modifier, wherein some of the protrusions and lysing elements are oriented in a non-axial direction and the non-axial protrusions do not extend beyond the width of the distal shaft.
FIG. 5b is an upper plan view illustrating the protrusions and lysing elements of an alternative embodiment of a tissue dissector and modifier, wherein some of the protrusions and lysing elements are oriented in a non-axial direction and some of the non-axial protrusions extend beyond the width of the distal shaft.
FIG. 5c is a lower plan view of the embodiment of FIG. 5a illustrating the protrusions and lysing elements of a tissue dissector and modifier, wherein some of the protrusions and lysing elements are oriented in a non-axial direction and the non-axial protrusions do not extend beyond the width of the distal shaft.
FIG. 5d is a lower plan view of the embodiment of FIG. 5b illustrating the protrusions and lysing elements of a tissue dissector and modifier, wherein some of the protrusions and lysing elements are oriented in a non-axial direction and some of the non-axial protrusions extend beyond the width of the distal shaft.
FIG. 6 depicts an embodiment comprising a modular, removable tip and a rigid shaft.
FIG. 7a is a side view of a robotic surgery system comprising a TDM.
FIG. 7b depicts an alternative robotic arm that may be used with the system of FIG. 7a. FIG. 8 depicts an embodiment comprising a modular, removable tip and a flexible shaft.
DETAILED DESCRIPTION
The term dissection may indicate the separation of tissues or of one tissue plane from another (ref: Free Online Medical Dictionary). Some also consider dissection to comprise separation of a single tissue into portions. Much of the bodies of animals and humans are formed from embryonic fusion planes. Many of the organs of the human body are categorized from the embryonic fusion planes from whence they came. The interfaces between organs may often be referred to as 'tissue planes.' Such planes may be considered substantially planar depending upon the size of a comparative planar living or inanimate object (such as a surgical instrument). As an example, a lobe of a human liver has a radius of curvature of about 5cm; however, compared to a surgical instrument of about 1cm in width capable of separating tissue in a plane, the curvilinear plane comprising the liver lobe may be 'substantially' planar and thus amenable to a tool capable of separating tissues in a 'substantially planar' fashion. Various vessels or ducts may also traverse within a given organ thus providing for areas of 'substantially planar' boundaries even within a given organ. Depending on the forces applied and/or available paths of least resistance, the TDM may divide what may appear to be isodense tissues. An example of separating isodense tissues may be separating one lobe of liver from another lobe within that liver. Depending on the density of a certain tumor, separation from the involved organ may also be an isodense dissection/separation. The TDM may perform the 75 functions of sharp dissection, blunt dissection and electrosurgical cutting and/or coagulation without a surgeon having to switch instruments. Sharp dissection has been referred to by some as separation of tissues by means of the sharp edge of a knife or scalpel or with the inner sharp edge of scissors. Blunt dissection has been defined by Webster as surgical separation of tissue layers by means of an instrument without a cutting edge or by the fingers. The term
80 'Loose connective tissue' has been used to refer to a category of connective tissue which
includes areolar tissue, reticular tissue, and adipose tissue. Loose connective tissue is the most common type of connective tissue in vertebrates. Loose connective tissue holds organs in place and attaches epithelial tissue to other underlying tissues; it also surrounds the blood vessels and nerves. Fibroblast cells are widely dispersed in this tissue; they are irregular
85 branching cells that secrete strong fibrous proteins and proteoglycans as an extracellular matrix.
The cells of this type of tissue are generally separated by quite some distance by a gel-like gelatinous substance primarily made up of collagenous and elastic fibers. Loose connective tissue is named based on the "weave" and type of its constituent fibers. There are three main types: Collagenous fibers: collagenous fibers are made of collagen and consist of bundles of
90 fibrils that are coils of collagen molecules. Elastic fibers: elastic fibers are made of elastin and are "stretchable." Reticular fibers: reticular fibers consist of one or more types of very thin collagen fibers; these fibers join connective tissues to other tissues. (Reference: Wikipedia). Areolar tissue (Latin for a little open space) is a common type of connective tissue, and may also be referred to as "loose connective tissue". It is strong enough to bind different tissue types
95 together, yet soft enough to provide flexibility and cushioning. It exhibits interlacing loosely
organized fibers, abundant blood vessels, and significant low density space. Areolar tissue fibers run in random directions and are mostly collagenous, but elastic and reticular fibers are also present. Areolar tissue is highly variable in appearance. In many serous membranes, it appears as a loose arrangement of collagenous and elastic fibers, scattered cells of various 100 types, abundant ground substance, and numerous blood vessels. In the skin and mucous
membranes, areolar tissue may be more compact and sometimes difficult to distinguish from dense irregular connective tissue. Areolar tissue is the most widely distributed connective tissue type in vertebrates. It is sometimes equated with "loose connective tissue". In other cases, "loose connective tissue" is considered a parent category that includes mucous
105 connective tissue, reticular connective tissue and adipose tissue. It may be found in tissue
sections from almost every part of the body. It surrounds blood vessels and nerves and penetrates with them even into the small spaces of muscles, tendons, and other tissues, (wiki). Dr. Michael Kendrick, Surgeon at Mayo Clinic, Rochester, says many Mayo surgeons today simply refer to loose connective tissues between or within organs as areolar tissue.
110 The term 'minimally invasive surgery' has been used to describe a procedure (surgical or otherwise) that is less invasive than open surgery used for the same purpose. Some minimally invasive procedures typically involve use of laparoscopic devices and remote-control manipulation of instruments with indirect observation of the surgical field through an endoscope or similar device, and are carried out through the skin or through a body cavity or anatomical 115 opening. This may result in shorter hospital stays, or allow outpatient treatment (reference:
Wikipedia).
Various implementations of methods are disclosed herein for dissecting and modifying various living tissues. The term 'modifying' in this context may refer to or may encompass application of energy to tissue using one or more lysing elements as discussed herein. The
120 term 'modifying' in this context may also refer to application of energy to tissue by way of an energy window as also described herein. Such methods may be performed using a Tissue Dissecting and Modifying Wand ("TDM"). Examples of various embodiments of such wands may be found in U.S. Patent No. 6,203,540 titled "Ultrasound and Laser Face-Lift and Bulbous Lysing Device," U.S. Patent No. 6,391 ,023 titled "Thermal Radiation Facelift Device," U.S.
125 Patent No. 6,432, 101 titled "Surgical Device for Performing Face-Lifting Using Electromagnetic Radiation," U.S. Patent No. 6,440, 121 titled "Surgical Device For Performing Face-Lifting Surgery Using Radiofrequency Energy," U.S. Patent No. 6,974,450 titled "Face-Lifting Device," and U.S. Patent No. 7,494,488 titled "Facial Tissue Strengthening and Tightening Device and Methods." The "Detailed Description of the Invention" section of each of these patents is
130 hereby incorporated herein by specific reference. With respect to U.S. Patent No. 6,203,540 titled "Ultrasound and Laser Face-Lift and Bulbous Lysing Device," the section titled "Description of the Preferred Embodiments" is hereby incorporated herein by specific reference.
Tissues or organs or tumors treated with the TDM may also undergo post traumatic collagen deposition or scarring. Thermal damage to collagen is likely brought about by
135 hydrolysis of cross-linked collagen molecules and reformation of hydrogen bonds resulting in loss of portions or all of the characteristic collagen triple-helix. New collagen formed as the result of trauma and some diseases is technically scar tissue. The encroachment of post traumatically derived collagen may influence already traumatized dissected tissue.
Some tissues of the body are of varying sensitivity to electrosurgical energy. Modulation
140 and feedback may be helpful for such tissues. For example, some liver tumors or tissues may allow heating to temperature ranges higher than temperatures that typically be involved in facial rejuvenation procedures In some implementations, liver tumors or tissues may be operated upon by heating the tissue to a temperature range of about 72-85° C.
The TDM may dissect tissue planes of dissimilar density as well as isodense tissue planes.
145 The TDM may also dissect different types of tissues from one another as well as dissect within an organ. It is possible that the cutting segments alone may traumatize or lyse portions of tissues sufficiently to carry out a given surgical method or procedure. It is also possible that when electrically energized with electro-cutting current, the TDM may possess a plasma field that may traumatize certain tumor cells in a potentially lethal fashion. The TDM may be 150 "energized" by various forms of energy in its top side energy window, as described in greater detail below. Such energy absorptions may result in the formation of heat which may, in turn, damage tumor or other tissue cells themselves, and/or their surrounding environment in order to achieve a desired effect of a surgical method or procedure.
In some embodiments, energy may be delivered from one or more energy windows so as to 155 heat tissue to a temperature of about 72°C to about 80°C. Various methods may therefore be implemented in which the amount of energy and/or the delivery time may be adjusted so as to heat the tissue to within a desired temperature range. Temperature sensors may therefore be incorporated on or near the energy windows to allow a surgeon to heat the tissue to a desired temperature or within a desired temperature range. In some embodiments, the sensor may be 160 configured to provide an average temperature over a particular period of time and or over a particular range of distances within the tissue. Systems consistent with the disclosure provided herein may be configured to prevent or to shut down or otherwise limit energy transfer if a particular tissue temperature were beyond a threshold or alternatively if an average temperature threshold is reached.
165 Temperature sensors that may be useful in connection with embodiments disclosed herein include, but are not limited to, resistance temperature sensors, such as carbon resistors, film thermometers, wire-wound thermometers, or coil elements. Some embodiments may comprise thermocouples, pyrometers, or non-contact temperature sensors, such as total radiation or photoelectric sensors. In some embodiments, one or more temperature sensors may be
170 coupled with a processor and/or a monitor to allow a surgeon to better visualize or otherwise control the delivery of energy to selected areas of target tissue. For example, some
embodiments may be configured such that a surgeon can visualize the temperature of tissue positioned adjacent to one or more locations along the TDM to ensure that such temperatures are within a desired temperature range. Some embodiments may alternatively, or additionally,
175 be configured such that one or more temperature sensors are coupled with a processor in a feedback loop such that energy delivery may be automatically adjusted by the system in response to temperature data. For example, when temperatures exceed a particular threshold, such as somewhere between about 65° C and about 90° C, the system may be configured to shut down or otherwise limit further energy delivery. In some such embodiments, the threshold
180 may be between about 68° C and about 75° C.
Some embodiments may comprise a feedback means, such as a visual, audible, or tactile feedback means, to provide information to a user to avoid excess energy delivery to tissues. In some embodiments, the feedback means may be configured to notify the surgeon when the temperature has reached a particular threshold. In some embodiments, the feedback means
185 may be configured to notify the surgeon when the TDM has been positioned in a particular location within the target region for a particular time period. Examples of visual feedback means include LED lights, LASERS, visual light source, display screen, etc. Examples of audible feedback means include speakers, alarms, audible vibration, etc., Examples of tactile feedback means include vibration, minimal electrical shock, heat, etc., The feedback means may be
190 configured with multiple thresholds with different feedback at each threshold. For example, at a first threshold, the TDM may be configured to deliver a first noise and at a second threshold the TDM may be configured to deliver a second noise. The second noise may be louder than the first noise to indicate a greater urgency for changing the energy delivery and/or moving the TDM from its current location within a patient's body. In some embodiments, an antenna(s) may be
195 present on the shaft or tip of the TDM. In some embodiments, a camera or fiberoptic may
gather optical data to allow the surgeon knowledge of the placement of the TDM.
In some implementations of methods according to the present disclosure, the TDM may be used to induce post-surgical collagen deposition and/or an inflammatory tissue reaction in the target zone. Some procedures intended to increase post-surgical collagen deposition, for
200 example, around a mesh implant, using the TDM are done by delivering energies of about 20 J/cm2. By contrast, in certain preferred implementations of methods for increasing post-surgical collagen deposition using the TDM, a higher energy delivery may be employed than 20 J/cm2. For example, some implementations for increasing post-surgical collagen deposition may be performed by delivering energy at a level 20% or more than 20 J/cm2.
205 The term Tissue Dissector (TD) is intended to encompass any of the devices for dissecting tissue disclosed herein including, but not limited to, Tissue Dissecting and Modifying Wands (TDM) comprising lysing elements, tissue dissecting wands lacking lysing elements, and tissue dissecting wands either comprising or lacking energy windows. In some embodiments the lysing elements may comprise lysing segments.
210 Further details regarding various embodiments will now be provided with reference to the drawings.
FIG. 1 a is a perspective view of an embodiment of a TDM with an electrosurgically energized energy window 107 on the upper side of the device. It should be noted that the term "energy window" is intended to encompass what is referred to as a planar-tissue-altering-
215 window/zone in U.S. Patent No. 7,494,488 and, as described later, need not be electrosurgically energized in all embodiments. In some embodiments, the "energy window" may comprise a variety of other energy emitting devices, including radiofrequency, intense pulsed light, LASER, thermal, microwave and ultrasound. It should also be understood that the term "energy window" does not necessarily imply that energy is delivered uniformly throughout the region comprising
220 the energy window. Instead, some energy window implementations may comprise a series of termini or other regions within which energy is delivered with interspersed regions within which no energy, or less energy, is delivered. This configuration may be useful for some implementations to allow for alteration of certain tissue areas with interspersed areas within which tissue is not altered, or at least is less altered. This may have some advantages for
225 certain applications due to the way in which such tissue heals. It is contemplated that in
alternative embodiments, electronically energized energy window 107 may be omitted.
FIG. 1 a is a perspective view of an embodiment of a TDM comprising a tip 101 , a shaft 102 and a handle 103. Electro-coagulation and electro-cutting energy arrives in electrical conduits 111 and/or 112 and may travel by wiring through the handle and shaft to termini 107a, which are
230 part of energy window 107. Electro-cutting and electro-coagulation currents may be controlled outside the TDM at an electrosurgical generator, such as the Bovie Aaron 1250™ or Bovie Icon GP™. In an embodiment, the tip may measure about 1 cm in width and about 1-2 mm in thickness. Sizes of about one-fifth to about five times these dimensions may also have possible uses. In some veterinary embodiments, tip sizes of about one-tenth to 20 times the
235 aforementioned dimensions may also have possible uses. In some embodiments, the tip can be a separate piece that is secured to shaft by a variety of methods such as a snap mechanism, mating grooves, plastic sonic welding, etc. Alternatively, in some other embodiments, the tip can be integral or a continuation of shaft made of similar metal or materials. In some embodiments, the tip may also be constructed of materials that are both electrically non-conductive and of low
240 thermal conductivity; such materials might comprise, for example, porcelain, ceramics, glass- ceramics, plastics, varieties of poiytetrafluoroethylene, carbon, graphite, and graphite-fiberglass composites.
In some embodiments, the tip may be constructed of a support matrix of an insulating material (e.g., ceramic or glass material such as alumina, zirconia). External conduits 111
245 and/or 112 may connect to electrically conductive elements to bring RF electrosurgical energy from an electrosurgical generator down the shaft 102 to electrically conductive lysing elements 105 mounted in the recessions in between the protrusions 104. In some embodiments, the protrusions may comprise bulbous protrusions. The tip shown in this embodiment has four relative protrusions and three relative recessions and provides for a monopolar tip conductive
250 element. All of the axes of the relative protrusions of the tip depicted in this embodiment extend at least substantially parallel to the axis of the shaft of the TDM (as viewed from Top). In embodiments of tips of such axial placement of protrusions and or relative recessions, surgeons may use methods of defining and or dissecting a target area by entering through an incision and then moving the TDM tip in a primarily axial direction forward and backward and reorienting the
255 TDM after the backstroke in a spokewheel pattern the TDM to access tissues adjacent to earlier strokes.
In the depicted embodiment, the tip 101 may alternatively be made partially or completely of concentrically laminated or annealed-in wafer layers of materials that may include plastics, silicon, glass, glass/ceramics, cermets or ceramics. Lysing elements 105 may also be made 260 partially or completely of a cermet material. Alternatively, in a further embodiment the tip may be constructed of insulation covered metals or electroconductive materials. In some embodiments, the shaft may be flat, rectangular or geometric in cross-section or substantially flattened. In some embodiments, smoothing of the edges of the shaft may reduce friction on the skin surrounding the entrance wound. In some further embodiments, the shaft may be made of
265 metal or plastic or other material with a completely occupied or hollow interior that can contain insulated wires, electrical conductors, fluid/gas pumping or suctioning conduits, fiber-optics, or insulation. In some embodiments the shaft may have a length of about 10-20cm. In some embodiments the handle may have a length of about 8-18cm.
In some embodiments, shaft plastics, such as polytetrafiuoroethy!ene may act as insulation
270 about wire or electrically conductive elements. In some embodiments, the shaft may
alternatively be made partially or completely of concentrically laminated or annealed-in wafer layers of materials that may include plastics, silicon, glass, glass/ceramics, ceramics carbon, graphite, graphite-fiberglass composites. Depending upon the intended uses for the device, an electrically conductive element internal to shaft may be provided to conduct electrical impulses
275 or RF signals from an external power/control unit (such as a Valleylab™ electrosurgical
generator) to another energy window 108. In some embodiments, energy windows 107 and/or 108 may only be substantially planar, or may take on other cross-sectional shapes that may correspond with a portion of the shape of the shaft, such as arced, stair-step, or other geometric shapes/curvatures. In the embodiments depicted in FIGS. 1a & 1 b, energy window 107 is
280 adjacent to protrusions 104, however other embodiments are contemplated in which an energy window may be positioned elsewhere on the shaft 102 or tip 101 of the wand, and still be considered adjacent to protrusions 104. For example, in an embodiment lacking energy window 107, but still comprising energy window 108, energy window 108 would still be considered adjacent to protrusion 104. However, if an energy window was placed on handle 103, such an
285 energy window would not be considered adjacent to the protrusions 104.
The conduit may also contain electrical control wires to aid in device operation. Partially hidden from direct view in FIGS. 1 a & 1 b, and located in the grooves defined by protrusions 104 are electrically conductive tissue lysing elements 105, which, when powered by an
electrosurgical generator, effects lysing of tissue planes on forward motion of the device. The
290 lysing elements may be located at the termini of conductive elements. In some embodiments, one or more sensors such as for example sensors 110 and 114 may be positioned on the device. The sensors 110 and 114 may comprise any of the sensors described in the specification herein. Other embodiments may comprise one or more sensors on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the
295 tip, and on the shaft. Sensors that may be useful include thermal sensors, photoelectric or photo optic sensors, cameras, etc. In some embodiments, one or more sensors may be used to monitor the local post passage electrical impedance or thermal conditions that may exist near the distal tip of the shaft or on the tip. Some embodiments may also comprise one or more sensors incorporating MEMS (Micro Electro-Mechanical Systems) technology, such as MEMS
300 gyroscopes, accelerometers, and the like. Such sensors may be positioned at any number of locations on the TDM, including within the handle in some embodiments. In some
embodiments, sensor 114 may comprise fiberoptic elements. In an embodiment, the sensor can be configured to sense a temperature of tissue adjacent to the apparatus. The temperature sensor may alternatively be configured or sense a temperature of one or more fluids adjacent to
305 the apparatus such as for example tissue fluids and/or fluids introduced by the surgeon.
Temperature and impedance values may be tracked on a display screen or directly linked to a microprocessor capable of signaling control electronics to alter the energy delivered to the tip when preset values are approached or exceeded. Typical instrumentation paths are widely known, such as thermal sensing thermistors, and may feed to analog amplifiers which, in turn,
310 feed analog digital converters leading to a microprocessor. In some embodiments, internal or external ultrasound measurements may also provide information which may be incorporated into a feedback circuit. In an embodiment, an optional mid and low frequency ultrasound transducer may also be activated to transmit energy to the tip and provide additional heating and may additionally improve lysing. In some embodiments, a flashing visible light source, for
315 example, an LED, can be mounted on the tip may show through the tissues and/or organs to identify the location of the device.
In some embodiments, one or more electromagnetic delivery elements 115 may be positioned on tip or shaft. Other embodiments may comprise one or more electromagnetic delivery elements on any other suitable location on the TDM, including but not limited to on the
320 protrusions or otherwise on the tip, and on the shaft. Electromagnetic delivery elements that may be useful include: LEDs, LASERS, fiberoptics, filaments, photoelectric materials, infrared emitters, etc.
Some embodiments may comprise a low cost, disposable, and one-time-use device.
However, in some embodiments intended for multiple uses, the tip's electrically conductive
325 tissue lysing elements be protected or coated with materials that include, but are not limited to, Silverglide™ non-stick surgical coating, platinum, palladium, gold and rhodium. Varying the amount of protective coating allows for embodiments of varying potential for obsolescence capable of either prolonging or shortening instrument life.
In some embodiments, the electrically conductive lysing element portion of the tip may arise
330 from a plane or plate of varying shapes derived from the aforementioned materials by methods known in the manufacturing art, including but not limited to additive manufacturing, cutting, stamping, pouring, molding, filing and sanding. In some embodiments, the electrically conductive lysing element 105 may comprise an insert attached to a conductive element in the shaft or continuous with a formed conductive element coursing all or part of the shaft. In some embodiments, one or more electrically conductive elements or wiring in conduit 1 11 and/or 1 12 brings RF electrosurgical energy down the shaft to electrically conductive lysing elements 105 associated in part with the recessions. In an embodiment, the electrosurgical energy via conduit 11 1 is predominately electro-cutting and/or a blend.
In some embodiments, the electrically conductive element or wiring may be bifurcated to employ hand switching if an optional finger switch is located on handle. The electrically conductive element or wiring leading from the shaft into the handle may be bundled with other electrical conduits or energy delivering cables, wiring and the like and may exit the proximal handle as insulated general wiring to various generators (including electrosurgical), central processing units, lasers and other sources as have been described herein. In some
embodiments, the plate making up lysing elements 105 may be sharpened or scalloped or made to slightly extend outwardly from the tip recessions into which the plate will fit.
Alternatively, in some embodiments, since cutting or electrical current may cause an effect at a distance without direct contact, the lysing element may be recessed into the relative recessions or grooves defined by the protrusions 104 or, alternatively, may be flush with protrusions 104. In some further adjustable embodiments, locations of the electrically
conductive lysing elements with respect to the protrusions may be adjusted by diminutive screws or ratchets. In some further adjustable embodiments, locations of the electrically conductive lysing elements with respect to the protrusions may be adjusted by MEMS or microelectronics. The plate, which in some embodiments is between 0.01 mm and 1 mm thick, can be sharpened to varying degrees on its forward facing surface. It is possible that plate sharpness may increase the efficiency with which electricity will pass from the edge cutting the target tissue. Sometimes, however, proper function even when variably dull or unsharpened may be unhampered since electrosurgical cutting current may cut beyond the electroconductive edge by a distance of over 1 mm. In some embodiments, the plate thickness may vary from 0.001 mm to 3mm thick.
In some embodiments, the electrically conductive lysing element may also exist in the shape of a simple wire of 0.1 mm and 1 mm 0.01 mm to 3mm. In some embodiments, the wire may measure between 0.01 mm to 3mm. Such a wire may be singly or doubly insulated as was described for the plate and may have the same electrical continuities as was discussed for the planar (plate) version. In some embodiments, an electrosurgical current for the electrically conductive lysing element is of the monopolar "cutting" variety and setting and may be delivered to the tip lysing conductor in a continuous fashion or, alternatively, a pulsed fashion. The surgeon can control the presence of current by a foot pedal control of the electrosurgical generator or by button control on the shaft (forward facing button). The amount of cutting current may be modified by standard interfaces or dials on the electrosurgical generator. In some embodiments, the electrosurgically energized tip current can be further pulsed at varying rates, by interpolating gating circuitry at some point external to the electrosurgical generator by standard mechanisms known in the art that may range from about 1 per second to about 60 per second. In some embodiments, the rate may vary from about 1 per second to about 150 per
375 second. In some embodiments, the electrosurgically energized tip current can be further pulsed at varying rates by gating circuitry within the electrosurgical generator by standard mechanisms known in the art. For some embodiments, the electrically conductive lysing element is a monopolar tip in contact with conductive elements in the shaft leading to external surgical cable leading to an electrosurgical generator from which emanates a grounding or dispersive plate
380 which may be placed elsewhere in contact with the patient's body, such as the thigh. Such circuitry may be controlled and gated/wired from the cutting current delivery system of the electro surgical generator. Acceptable electrosurgical generators may include Valley Lab Force 1 B™ with maximum P-P voltage of 2400 on "cut" with a rated load of 300 Ohms and a maximum power of 200 Watts, 35 maximum P-P voltage of 5000 on "coagulate" with a rated
385 load of 300 Ohms, and a maximum power of 75 Watts ValleyLab Force 4 has a maximum P-P voltage of 2500 on "cut" with a rated load of 300 Ohms and a maximum power of 300 Watts, 750kHz sinusoidal waveform output, maximum P-P voltage of 9000 on "coagulate" with a rated load of 300 Ohms and a maximum power of 120 Watts using a 750kHz damped sinusoidal with a repetition frequency of 31 kHz. In an embodiment, the tip may also be manufactured from
390 multilayer wafer substrates comprised of bonded conductive strips and ceramics. Suitable conductive materials include but are not limited to those already described for tip manufacture.
In alternative embodiments, the electrically conductive lysing elements may be bifurcated or divided into even numbers at the relative recessions, insulated and energized by wiring to an even number of electrical conduits in a bipolar fashion and connected to the bipolar outlets of
395 the aforementioned electrosurgical generators. Rings partly or completely encircling the shaft of the hand unit can be linked to a partner bipolar electrode at the tip or on the energy window. Such bipolar versions may decrease the available power necessary to electrically modify certain tissues, especially thicker tissues. In alternative embodiments, the lysing elements may be divided into odd numbers yet still allow for bipolar flow between two or more elements as those
400 of ordinary skill in the art would appreciate.
FIG. 1 b is a side elevation view of the embodiment previously depicted in FIG. 1a. In the depicted embodiment, tip 101 may be made of materials that are both electrically non- conductive and of low thermal conductivity such as porcelain, epoxies, ceramics, glass- ceramics, plastics, or varieties of polytetraf!uoroethylene. Alternatively, the tip may be made
405 from metals or electroconductive materials that are completely or partially insulated. Note the relative protrusions and relative recessions are not completely visible from this viewing angle. In some embodiments, the relative recessions of the tip is the electrically conductive tissue lysing element 105 (usually hidden from view at most angles) which may have any geometric shape including a thin cylindrical wire; the electrically conductive lysing element can be in the shape of
410 a plate or plane or wire and made of any metal or alloy that does not melt under operating
conditions or give off toxic residua. Optimal materials may include but are not limited to steel, nickel, alloys, palladium, gold, tungsten, silver, copper, and platinum. Metals may become oxidized thus impeding electrical flow and function. In alternative embodiments the geometry of the tip area may comprise protrusions that are not oriented along the axis of the shaft (as
415 seen from a top view); some of these alternative embodiments for tip area geometries are
depicted in Figures 5a,b,c,d,e,f,g,h and Figures 6a,b,c,d. Some embodiments may be configured to be modular and/or comprise disposable tips such that a surgeon can place an appropriate tip for a particular surgery on the shaft. Alternatively or additionally one or more of the tips may be disposable such that a surgeon may dispose of the tip after performing surgery
420 and install a new tip for subsequent surgeries or a continuation of the current surgery with a new tip.
In some embodiments, one or more suction/vacuum ports 117 may be provided on or about the tip or distal shaft. The port(s) may be fluidly coupled with a vacuum; the vacuum may comprise a pump or a negative pressure chamber or a syringe at the end of a fluid conduit.
425 Other embodiments may comprise one or more suction/vacuum ports on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft. In some embodiments, a fluid delivery port 116 may be provided. In some embodiments the fluid delivery port may be coupled with a pump or high pressure fluid. In some embodiments the port may be perpetually open such that fluid may be delivered
430 therethrough upon actuation of a pump or fluid pressure system. In other embodiments the port may be closed and selectively opened to deliver fluid therethrough. Other embodiments may comprise one or more fluid ports on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft. Fluid ports that may be useful may comprise channels within the TDM, polymer lines, hoses, etc. Fluids that may
435 emanate from the outlet may comprise ionic fluids such as saline, medicines (including but not limited to antibiotics, anesthetics, antineoplastic agents, bacteriostatic agents, etc.), non-ionic fluids, and or gasses (including but not limited to nitrogen, argon, air, etc.). In some
embodiments fluids may be under higher pressures or sprayed. It should be understood that although these elements (116 & 117) are not depicted in every one of the other figures, any of
440 the embodiments described herein may include one or more such elements.
In some embodiments, a vibration means 170b may be positioned in the handle. Other embodiments may comprise one or more vibration means on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft. Examples of suitable vibration means may include piezoelectric materials, ultrasonic motors 445 with stators, piezoelectric actuators, vibration motor such as an off-center weight mounted on a gear, etc. Some vibration means may be configured to emit ultrasound in the 20-40kHz range. Yet other vibration means may include electromagnet drivers with a frequency of operation in the range of 150-400Hz. In some embodiments, one or more vibration means may be used to provide additional forces which may facilitate passage of the TDM. In some embodiments, one
450 or more vibration means may be used to reduce debris on the electrosurgical or other
components of the TDM. In a further embodiment, a vibration means may be directly or indirectly connected to one or more of the lysing elements. Some vibration means may help to decrease and/or remove debris. In some embodiments use of a vibration means may, also or alternatively, be used to assist in migrating the TDM through tissue during the procedure. In
455 some such embodiments, it is thought that use of a vibration means having a lower frequency may be particularly useful for assisting in such migration. In addition, positioning the vibration means closer to a handle of the TDM may facilitate such migration as well. By contrast, positioning the vibration means on or near the tip, and/or using a higher frequency vibrations means may be particularly useful for preventing buildup of debris on the tip.
460 In the depicted embodiment, 118 represents an antenna configured to deliver a signal to a receiver unit. In some embodiments, antenna 118 may comprise a radiofrequency identification (RFID) TAG. In some embodiments the RFID tag may comprise an RFID transponder. In other embodiments the RFID tag may comprise a passive tag. It should be understood that antenna 118 is not depicted in every one of the other figures, any of the embodiments described herein
465 may comprise one or more such elements. Other embodiments may comprise one or more antenna on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft. In embodiments in which antenna 1 18 comprises an RFID transponder, the RFID transponder may comprise a microchip, such as a microchip having a rewritable memory. In some embodiments, the tag may measure less than
470 a few millimeters. In some embodiments a reader may generate an alternating electromagnetic field which activates the RFID transponder and data may be sent via frequency modulation. In an embodiment, the position of the RFID tag or other antenna may be determined by an alternating electromagnetic field in the ultra-high frequency range. The position may be related to a 3 dimensional mapping of the subject. In an embodiment the reader may generate an
475 alternating electromagnetic field. In some such embodiments, the alternating electromagnetic field may be in the shortwave (13.56MHz) or UHF (865-869MHz) frequency. Examples of potentially useful systems and methods for mapping/tracking a surgical instrument in relation to a patient's body may be found in U.S. Patent Application Publication No. 2007/0225550 titled "System and Method for 3-D Tracking of Surgical Instrument in Relation to Patient Body, which
480 is hereby incorporated by reference in its entirety.
In some embodiments, a transmission unit may be provided that may generate a high- frequency electromagnetic field configured to be received by an antenna of the RFID tag or another antenna. The antenna may be configured to create an inductive current from the electromagnetic field. This current may activate a circuit of the tag, which may result in
485 transmission of electromagnetic radiation from the tag. In some embodiments, this may be accomplished by modulation of the field created by the transmission unit. The frequency of the electromagnetic radiation emitted by the tag may be distinct from the radiation emitted from the transmission unit. In this manner, it may be possible to identify and distinguish the two signals. In some embodiments, the frequency of the signal from the tag may lie within a side range of
490 the frequency of the radiation emitted from the transmission unit. Additional details regarding RFID technology that may be useful in connection with one or more embodiments discussed herein may be found in, for example, U.S. Patent Application Publication No. 2009/0281419 titled "System for Determining the Position of a Medical Instrument," the entire contents of which are incorporated herein by specific reference.
495 In other embodiments, antenna 118 may comprise a Bluetooth antenna. In such
embodiments, multiple corresponding Bluetooth receivers at known locations may be configured to sense signal strengths from the Bluetooth antenna 118 and triangulate such data in order to localize the signal from the Bluetooth antenna 118 and thereby locate the TDM within a patient's body. Other embodiments may be configured to use angle-based, electronic localization
500 techniques and equipment in order to locate the antenna 118. Some such embodiments may comprise use of directional antennas, which may be useful to increase the accuracy of the localization. Still other embodiments may comprise use of other types of hardware and/or signals that may be useful for localization, such as WIFI and cellular signals, for example.
One or more receiver units may be set up to receive the signal from the tag. By evaluating,
505 for example, the strength of the signal at various receiver units, the distances from the various receiver units may be determined. By so determining such distances, a precise location of the TDM relative to a patient and/or a particular organ or other surgical site on the patient may be determined. In some embodiments, a display screen with appropriate software may be coupled with the RFID or other localization technology to allow a surgeon to visualize at least an
510 approximate location of the tag/antenna, and therefore TDM, relative to the patient's body.
Some embodiments may be further configured such that data from the antenna(s) may be used in connection with sensor data from the TDM. For example, some embodiments of TDMs comprising one or more sensors may be further configured with one or more RFID tags. As such, data from the one or more sensors may be paired or otherwise used in connection with
515 data from the one or more RFID tags or other antennas. For example, some embodiments may be configured to provide information to a surgeon regarding one or more locations on the body from which one or more sensor readings were obtained. To further illustrate using another example, information regarding tissue temperature may be combined with a location from which such tissue temperature(s) were taken. In this manner, a surgeon may be provided with specific
520 information regarding which locations within a patient's body have already been treated in an effective manner and thus which locations need not receive further treatment using the TDM.
In some such embodiments, a visual display may be provided comprising an image of the patient's body and/or one or more selected regions of a patient's body. Such a system may be configured so as to provide a visual indication for one or more regions within the image
525 corresponding to regions of the patient's tissue that have been sufficiently treated. For
example, a display of a patient's liver may change colors at locations on the display that correspond with regions of the liver that have experienced a sufficient degree of fibrosis or other treatment. Such regions may, in some embodiments, be configured such that pixels
corresponding to particular regions only light up after the corresponding tissue in that region
530 reaches a particular threshold temperature.
Such sensors 110 and/or 1 14, 210 and/or 214, 310 and/or 314, 410 and/or 414, 510a and/or 514a, 510b and/or 514b, 610a and/or 614a, 610b and/or 614b, may be coupled with an antenna, which may send and/or receive one or more signals to/from a processing
unit. Alternatively, or additionally, data from such sensors resulting from tissue and/or fluid
535 analysis using such sensors may be stored locally and transmitted later. As yet another
alternative, such a signal may be transmitted following surgery. In such implementations, the signals need not necessarily be transmitted wirelessly. In fact, some embodiments may be configured to store data locally, after which a data module, such as a memory stick, may be removed from the TDM and uploaded to a separate computer for analysis.
540 In some embodiments tip 101 may be attached to a robotic arm. In some embodiments, tip
101 and portion of shaft 102 may be attached to a robotic arm. In some embodiments tip 101 and/or a portion of shaft 102 and/or a portion shaft and/or portion of handle 103 may be attached to a robotic arm. In some embodiments, the robotic arm may comprise one or more motors such as a screw-drive motor, gear motor, hydraulic motors, etc. In some embodiments
545 the robotic arm system may comprise worm gearheads, video cameras, motor control circuits, monitors, remote control devices, illumination sources, tactile interface, etc.
FIG. 1 c is a front elevation view of an embodiment of the embodiment previously depicted in FIG. 1 a. In this depicted embodiment, there are 4 protrusions and 3 lysing segment recessions 105c; the vertical height of a protrusion may be about 3mm and the horizontal width may be
550 about 2mm. In this depicted embodiment, the relatively oval protrusions 104c may be shaped similarly to a commercial jetliner nose cone in order to reduce drag and lower resistance to facilitate tissue passage. In some embodiments, tip protrusion shapes may take on a wide variety of geometric shapes including, but not limited to, stacked rectangles or tapered thin rectangles as discussed elsewhere. In some further embodiments the relative projection shapes
555 that may include, but should not be limited to: spheroid, sphere, sphere on cylinder, sphere on pyramid, sphere on cone, cone, cylinder, pyramid, and polyhedron.
FIG. 1 d is a front elevation view of an alternative embodiment having two protrusions 104d and one lysing segment (recession) wherein the lysing segment 105d connecting the two protrusions is substantially centered midway between the upper and lower portions of the
560 protrusions. In the depicted embodiment, the vertical height of the protrusions may be about 3mm and the horizontal width may be about 2mm. Thus, the lysing segment may be placed about 1.5mm from the upper portion of the protrusion. FIG. 1e is a front elevation view of another embodiment having two protrusions and one lysing segment 105e wherein the lysing segment connecting the two protrusions 104e is substantially centered in the upper third of the
565 way (on the upper side) between the upper and lower portions of the protrusions. In the
depicted embodiment, the vertical height of the protrusions may be about 3mm and the horizontal width may be about 2mm. Thus, the lysing segment may be placed about 1 mm from the upper portion of the protrusion.
FIG. 1f is a front elevation view of another embodiment having two protrusions and one
570 lysing segment wherein the lysing segment 105f connecting the two protrusions 104f is
substantially centered in the lower third (on the lower side) between the upper and lower portions of the protrusions. In the depicted embodiment, the vertical height of the protrusions may be about 3mm and the horizontal width may be about 2mm. Thus, the lysing segment may be placed about 2mm from the upper portion of the protrusion. As discussed above, some
575 embodiments may be configured such that the position of the lysing segment(s) relative to the protrusions is adjustable, such as adjustable between the embodiments shown in Figures 1 d-1f.
FIG. 1g is a cross-sectional view of an embodiment of a TDM illustrating some examples of some of the canals that may be used with the device. For example, canal 130 may comprise an electrode canal for delivering electrical energy to one or more of the lysing elements and/or the
580 energy window(s). Canal 132 may comprise an optics canal for delivering and/or receiving optical signals or energy, such as a LASER, fiber optics, intense pulse light, or for receiving an optical sensor. Canal 134 may comprise a vacuum tube for sucking fluids away from the surgical site, such as bodily fluids and/or fluids introduced by the TDM during the surgery. One or more of these canals may be configured for delivering one or more fluids using the TDM. For
585 example, canal 136 may comprise a fluid delivery canal for delivering an ionic fluid, such as a saline solution. Canal 136 may be configured to deliver a fluid that is both ionic and an anesthetic, such as a tumescent anesthesia. In some embodiments, canal 136 may be configured to deliver a fluid containing multiple individual fluids, such as a Klein Formula. Canal 138 may serve as a coaxial cable canal, such as for delivering a microwave signal to the energy
590 window, for example. Canals 140 and 142 may comprise duplicates of any one of the foregoing canals 130-138. One or more of the canals 130-142 may be coated with copper or another conductive metal to insulate the signals from those within other canals. It should be understood that although these canals are not depicted in other figures, any of the embodiments described herein may comprise one or more such canals configured for any of the uses described herein. 595 It should also be understood that although the canals shown in FIG. 1g are shown as having rectangular cross sections, any other cross sectional shape, including but not limited to circular cross sections, may be used.
FIGs. 1 h,i depict an embodiment that differs from the embodiment depicted in FIGs. 1a, b in that FIGs. 1 h,i lack or do not comprise energy windows 107 and/or 108. Each of the other 600 elements depicted in FIGs. 1 h,i may be identical to the corresponding elements shown in FIGs.
1 a,b and are referenced by like numerals (with alphanumeric). For example, in FIGs. 1 h,i shaft
102h.
FIG. 1 h is a perspective view of an embodiment of a TDM comprising tip 101 h and/or shaft 102h and/or handle 103h.
605 FIG. 1 h is a perspective view of an embodiment of a TDM comprising a tip 101 h, a shaft
102h and a handle 103h.
External conduits 111 h and/or 112h may connect to electrically conductive elements to bring RF electrosurgical energy from an electrosurgical generator down the shaft 102h to electrically conductive lysing elements 105h mounted in the recessions in between the
610 protrusions 104h.
In some embodiments, one or more sensors such as for example sensors 110 and 114 may be positioned on the device. The sensors 110 and 114 may comprise any of the sensors described in the specification herein. Other embodiments may comprise one or more sensors on any other suitable location on the TDM, including but not limited to on the protrusions or
615 otherwise on the tip, and on the shaft. Sensors that may be useful include thermal sensors, photoelectric or photo optic sensors, cameras, etc. In some embodiments, one or more sensors may be used to monitor the local post passage electrical impedance or thermal conditions that may exist near the distal tip of the shaft or on the tip. Some embodiments may also comprise one or more sensors incorporating MEMS (Micro Electro-Mechanical Systems) technology,
620 such as MEMS gyroscopes, accelerometers, and the like. Such sensors may be positioned at any number of locations on the TDM, including within the handle in some embodiments. In some embodiments, sensor 114 may comprise fiberoptic elements. In an embodiment, the sensor can be configured to sense a temperature of tissue adjacent to the apparatus. The temperature sensor may alternatively be configured or sense a temperature of one or more
625 fluids adjacent to the apparatus such as for example tissue fluids and/or fluids introduced by the surgeon.
In some embodiments, one or more electromagnetic delivery elements 115h may be positioned on tip or shaft. Other embodiments may comprise one or more electromagnetic delivery elements on any other suitable location on the TDM, including but not limited to on the 630 protrusions or otherwise on the tip, and on the shaft. Electromagnetic delivery elements that may be useful include: LEDs, LASERS, fiberoptics, filaments, photoelectric materials, infrared emitters, etc.
FIG. 1 i is a side elevation view of the embodiment previously depicted in FIG. 1 h. In alternative embodiments the geometry of the tip area may comprise protrusions that are not
635 oriented along the axis of the shaft (as seen from a top view); some of these alternative
embodiments for tip area geometries are depicted in Figures 5a,b,c,d. Some embodiments may be configured to be modular and/or comprise disposable tips such that a surgeon can place an appropriate tip for a particular surgery on the shaft. In some embodiments, one or more suction/vacuum ports 117i may be provided on or about the tip or distal shaft. The port(s)
640 may be fluidly coupled with a vacuum; the vacuum may comprise a pump or a negative
pressure chamber or a syringe at the end of a fluid conduit. Other embodiments may comprise one or more suction/vacuum ports on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft. In some embodiments, a fluid delivery port 116i may be provided. It should be understood that although these elements
645 (116 & 117) are not depicted in every one of the other figures, any of the embodiments
described herein may include one or more such elements.
In some embodiments, a vibration means 170h may be positioned in the handle.
In the depicted embodiment, 118i represents an antenna configured to deliver a signal to a receiver unit. In some embodiments, antenna 118i may comprise a radiofrequency
650 identification (RFID) TAG. In some embodiments the RFID tag may comprise an RFID
transponder. In other embodiments the RFID tag may comprise a passive tag. It should be understood that antenna 118i is not depicted in every one of the other figures, any of the embodiments described herein may comprise one or more such elements. Other embodiments may comprise one or more antenna on any other suitable location on the TDM, including but not
655 limited to on the protrusions or otherwise on the tip, and on the shaft. In embodiments in which antenna 118i comprises an RFID transponder, the RFID transponder may comprise a microchip, such as a microchip having a rewritable memory. In some embodiments, the tag may measure less than a few millimeters. In some embodiments a reader may generate an alternating electromagnetic field which activates the RFID transponder and data may be sent via
660 frequency modulation. In an embodiment, the position of the RFID tag or other antenna may be determined by an alternating electromagnetic field in the ultra-high frequency range. The position may be related to a 3 dimensional mapping of the subject. In an embodiment the reader may generate an alternating electromagnetic field. In some such embodiments, the alternating electromagnetic field may be in the shortwave (13.56MHz) or UHF (865-869MHz)
665 frequency. Examples of potentially useful systems and methods for mapping/tracking a surgical instrument in relation to a patient's body may be found in U.S. Patent Application Publication No. 2007/0225550 titled "System and Method for 3-D Tracking of Surgical Instrument in Relation to Patient Body, which is hereby incorporated by reference in its entirety.
In other embodiments, antenna 118 may be a Bluetooth antenna. Other embodiments may
670 be configured to use angle-based, electronic localization techniques and equipment in order to locate the antenna 118. Some such embodiments may comprise use of directional antennas, which may be useful to increase the accuracy of the localization. Still other embodiments may comprise use of other types of hardware and/or signals that may be useful for localization, such as WIFI and cellular signals, for example.
675 Such sensors 11 Oh and/or 114h, may be coupled with an antenna, which may send and/or receive one or more signals to/from a processing unit. Alternatively, or additionally, data from such sensors resulting from tissue and/or fluid analysis using such sensors may be stored locally and transmitted later. As yet another alternative, such a signal may be transmitted following surgery. In such implementations, the signals need not necessarily be transmitted
680 wirelessly. In fact, some embodiments may be configured to store data locally, after which a data module, such as a memory stick, may be removed from the TDM and uploaded to a separate computer for analysis.
In some embodiments tip 101 h may be attached to a robotic arm. In some embodiments, tip 101 h and portion of shaft 102h may be attached to a robotic arm. In some embodiments tip
685 101 h and/or a portion of shaft 102h and/or a portion shaft and/or portion of handle 103h may be attached to a robotic arm. In some embodiments, the robotic arm may comprise one or more motors such as a screw-drive motor, gear motor, hydraulic motors, etc. In some embodiments the robotic arm system may comprise worm gearheads, video cameras, motor control circuits, monitors, remote control devices, illumination sources, tactile interface, etc.
690 In an embodiment, a feedback means may be present for providing information to a user to avoid excess energy delivery to tissue. In another embodiment, the feedback means may be configured to notify a user when a temperature of tissue adjacent to the apparatus has reached a predetermined threshold temperature. In an embodiment, the feedback means may comprise an antenna. In an embodiment, the antenna may comprise a radiofrequency identification tag.
695 In an embodiment, the radiofrequency identification tag comprises a passive tag. In an
embodiment the visual information may comprise an indication of the one or more regions that have reached a predetermined threshold temperature.
In an embodiment, a feedback means may be present for providing information to a user to avoid excess energy delivery to tissue. In another embodiment, the feedback means may be
700 configured to notify a user when a temperature of tissue adjacent to the apparatus has reached a predetermined threshold temperature. In an embodiment, the feedback means may comprise an antenna. In an embodiment, the antenna may comprise a radiofrequency identification tag. In an embodiment, the radiofrequency identification tag comprises a passive tag. In an embodiment, the radiofrequency identification tag may be configured to allow for determining
705 the position of the tag relative to a patient using an alternating electromagnetic field. In an
embodiment a temperature sensor may be configured to sense a temperature of tissue positioned adjacent to the apparatus during an operation. In an embodiment, a display unit may be configured to display information to a user during an operation. In an embodiment, the display unit may be configured to display visual information comprising information from the
710 temperature sensor and the radiofrequency identification tag such that a user can visualize one or more regions within a patient's body that have been sufficiently treated.
In an embodiment the visual information may comprise an indication of the one or more regions that have reached a predetermined threshold temperature. In an embodiment an alternating electromagnetic field may be one of a shortwave and UHF frequency. In another
715 embodiment, at least one lysing element may comprise at least one lysing segment. In some embodiments at least one lysing element may be positioned between at least two adjacent protrusions among the plurality of protrusions and/or an antenna positioned on the tissue dissecting and modifying wand and configured to provide location data regarding a location of the tissue dissecting and modifying wand during a procedure and/or receiving data from the
720 tissue dissecting and modifying wand generated from the antenna, wherein the data allows a user to determine one or more regions within a patient's body that have been treated. In an embodiment, at least one lysing element may comprise at least one lysing segment.
FIG. 2a is a perspective view of an embodiment of a TDM with an alternative energy window 207 on the upper side of the device configured to hold a thermochromic film. It should be noted
725 that the term "energy window" is intended to encompass what is referred to as a planar-tissue- altering-window/zone in U.S. Patent No. 7,494,488 and, as described herein, need not contain a thermochromic film in all embodiments. In some embodiments, the "energy window" may comprise a variety of other energy emitting devices, including radiofrequency, thermochromic, intense pulsed light, LASER, thermal, microwave and ultrasonic. It should also be understood
730 that the term "energy window" does not necessarily imply that energy is delivered uniformly throughout the region comprising the energy window. Instead, some energy window
implementations may comprise a series of termini or other regions within which energy is delivered with interspersed regions within which no energy, or less energy, is delivered. This configuration may be useful for some implementations to allow for alteration of certain tissue
735 areas with interspersed areas within which tissue is not altered, or at least is less altered. This may have some advantages for certain applications due to the way in which such tissue heals. In some embodiments, certain components of an energy window, such as the electro- conductive components of the energy window, could comprise a cermet. It is contemplated that in alternative embodiments, Thermochromic Containing Energy Window 207 may be omitted.
740 FIG. 2a is a perspective view of an embodiment of a TDM comprising a tip 201 , a shaft 202 and a handle 203. Electrosurgical energy may be delivered in electrical conduits 211 and/or 212 whereas LASER energy may be delivered by fiberoptic 222 or a waveguide and may travel by fiberoptic or waveguide through the handle and shaft to energy window 207, which may comprise a thermochromic film. A second energy window 208 may also be included in some
745 embodiments, and may comprise yet another thermochromic film or another variety of energy emitting device. Electro-cutting and electro-coagulation currents may be controlled outside the TDM at an electrosurgical generator, such as the Bovie Aaron 1250™ or Bovie Icon GP™. In some embodiments, the tip may measure about 1cm in width and about 1-2 mm in thickness. Sizes of about one-fifth to about five times these dimensions may also have possible uses. In
750 some veterinary embodiments, tip sizes of about one-tenth to 20 times the aforementioned dimensions may also have possible uses. In some embodiments, the tip can be a separate piece that may be secured to a shaft by a variety of methods, such as a snap mechanism, mating grooves, plastic sonic welding, etc. Alternatively, in some other embodiments, the tip can be integral or a continuation of a shaft made of similar metal(s) or material(s). In some
755 embodiments, the tip may also be constructed of materials that are both electrically non- conductive and of low thermal conductivity; such materials might comprise, for example, porcelain, ceramics, glass-ceramics, plastics, varieties of polytetrafluoroethylene, carbon, graphite, and graphite-fiberglass composites.
In some embodiments, the tip may be constructed of a support matrix of an insulating
760 material (e.g., ceramic or glass material such as alumina, zirconia). Conduits 211 and/or 212 may connect to electrically conductive elements to bring RF electrosurgical energy from an electrosurgical generator down the shaft 202 to electrically conductive lysing elements 205 mounted in the recessions in between protrusions 204. In some embodiments, the protrusions may comprise bulbous protrusions. The tip shown in this embodiment has four relative
765 protrusions and three relative recessions and provides for a monopolar tip conductive element.
All of the axes of the relative protrusions of the tip depicted in this embodiment extend at least substantially parallel to the axis of the shaft of the TDM (as viewed from Top). In embodiments of tips of such axial placement of protrusions and or relative recessions, surgeons may use methods of defining and or dissecting a target area by entering through an incision and then
770 moving the TDM tip in a primarily axial direction forward and backward and reorienting the TDM after the backstroke in a spokewheel pattern the TDM to access tissues adjacent to earlier strokes. In the depicted embodiment, the tip 201 may alternatively be made partially or completely of concentrically laminated or annealed-in wafer layers of materials that may include plastics, silicon, glass, glass/ceramics or ceramics. Lysing elements 205 may also be made
775 partially or completely of a cermet material. Alternatively, in a further embodiment, the tip may be constructed of insulation covered metals or electroconductive materials. In some
embodiments, the shaft may be flat, rectangular, or geometric in cross-section, or may be substantially flattened. In some embodiments, smoothing of the edges of the shaft may reduce friction on the tissues surrounding the entrance wound. In some further embodiments, the shaft
780 may be made of metal or plastic or other material with a completely occupied or hollow interior that can contain insulated wires, electrical conductors, fluid/gas pumping or suctioning conduits, fiber-optics, or insulation.
In some embodiments, shaft plastics, such as polytetrafluoroethylene, may act as insulation about wire or electrically conductive elements. In some embodiments, the shaft may
785 alternatively be made partially or completely of concentrically laminated or annealed-in wafer layers of materials that may include plastics, silicon, glass, glass/ceramics, ceramics carbon, graphite, and/or graphite-fiberglass composites. Depending upon the intended uses for the device, an electrically conductive element internal to the shaft may be provided to conduct electrical impulses or RF signals from an external power/control unit (such as a Valleylab™
790 electrosurgical generator) to another energy window 208. In some embodiments, energy
windows 207 and/or 208 may only be substantially planar, or may take on other cross-sectional shapes that may correspond with a portion of the shape of the shaft, such as arced, stair-step, or other geometric shapes/curvatures. In some embodiments, energy window 208 may comprise another thermochromic film. In the embodiments depicted in FIGS. 2a & 2b, energy
795 window 207 is adjacent to protrusions 204, however other embodiments are contemplated in which an energy window may be positioned elsewhere on the shaft 202 or tip 201 of the wand, and still be considered adjacent to protrusions 204. For example, in an embodiment lacking energy window 207, but still comprising energy window 208, energy window 208 would still be considered adjacent to protrusion 204. However, if an energy window was placed on handle
800 203, such an energy window would not be considered adjacent to protrusions 204.
The conduit(s) may also contain electrical control wires to aid in device operation. Partially hidden from direct view in FIGS. 2a & 2b, and located in the recessions defined by protrusions 204, are electrically conductive tissue lysing elements 205, which, when powered by an electrosurgical generator, effects lysing of tissue planes on forward motion of the device. The
805 lysing elements may be located at the termini of conductive elements. In some embodiments, one or more sensors such as for example sensors 210 and 214 may be positioned on the device. The sensors 210 and 214 may comprise any of the sensors described in the specification herein. Other embodiments may comprise one or more sensors on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the
810 tip, and on the shaft. Sensors that may be useful include thermal sensors, photoelectric or photo optic sensors, cameras, etc. In some embodiments, one or more sensors may be used to monitor the local post passage electrical impedance or thermal conditions that may exist near the distal tip of the shaft or on the tip. Some embodiments may also comprise one or more sensors incorporating MEMS (Micro Electro-Mechanical Systems) technology, such as MEMS 815 gyroscopes, accelerometers, and the like. Such sensors may be positioned at any number of locations on the TDM, including within the handle in some embodiments. In some
embodiments, sensor 214 may comprise fiberoptic elements. In an embodiment, the sensor can be configured to sense a temperature of tissue adjacent to the apparatus. The temperature sensor may alternatively be configured or sense a temperature of one or more fluids adjacent to
820 the apparatus such as for example tissue fluids and/or fluids introduced by the surgeon.
Temperature and impedance values may be tracked on a display screen or directly linked to a microprocessor capable of signaling control electronics to alter the energy delivered to the tip when preset values are approached or exceeded. Typical instrumentation paths are widely known, such as thermal sensing thermistors, and may feed to analog amplifiers which, in turn,
825 feed analog digital converters leading to a microprocessor. In some embodiments, internal or external ultrasound measurements may also provide information which may be incorporated into a feedback circuit. In an embodiment, an optional mid and low frequency ultrasound transducer may also be activated to transmit energy to the tip and provide additional heating and may additionally improve lysing. In some embodiments, a flashing visible light source, for
830 example, an LED, can be mounted on the tip may show through the tissues and/or organs to identify the location of the device.
In some embodiments, one or more electromagnetic delivery elements 215 may be positioned on tip or shaft. Other embodiments may comprise one or more electromagnetic delivery elements on any other suitable location on the TDM, including but not limited to on the
835 protrusions or otherwise on the tip, and on the shaft. Electromagnetic delivery elements that may be useful include: LEDs, LASERS, fiberoptics, filaments, photoelectric materials, infrared emitters, etc.
FIG. 2b is a side elevation view of the embodiment previously depicted in FIG. 2a. In the depicted embodiment, tip 201 which terminates in protrusions 206 may be made of materials
840 that are both electrically non-conductive and of low thermal conductivity such as porcelain, epoxies, ceramics, glass-ceramics, plastics, or varieties of poiytetrafluoroethylene. Alternatively, the tip may be made from metals or electroconductive materials that are completely or partially insulated. Note the relative protrusions and relative recessions are not completely visible from this viewing angle. The tip shown in this embodiment has four relative protrusions and three
845 relative recessions and provides for a monopolar tip conductive element. In some
embodiments, the electrically conductive tissue lysing element(s) 205 (usually hidden from view at most angles), which may have any geometric shape including a thin cylindrical wire, may be positioned within the relative recessions of the tip. The electrically conductive lysing element can be in the shape of a plate or plane or wire and made of any metal or alloy that does not melt
850 under operating conditions or give off toxic residua. Optimal materials may include but are not limited to steel, nickel, alloys, palladium, gold, tungsten, silver, copper, and platinum. Metals may become oxidized thus impeding electrical flow and function. In some further adjustable embodiments, locations of the electrically conductive lysing elements with respect to the protrusions may be adjusted by MEMS or microelectronics.
855 Thus far in medicine and surgery, thermochromic films have principally seen use as sensors or detection devices and thus absorb energy and contribute to modifying said energy into quantifiable information or data; for example, applying organic thermochromic indicators to surgical instruments with radiofrequency power "jaws" to visually indicate to a surgeon when a given temperature is reached, however such an "organically sensitive" device has replacement
860 cartridges (e.g., as shown in U.S. Patent No. 7,041 , 102 titled "Electrosurgical working end with replaceable cartridges," which is hereby incorporated by reference).
Herein, the use of thermochromic films is presented for a diametrically opposite purpose: to pump a defined quantity of energy into a living system to alter tissue. As opposed to traditional electrical resistance based thermal emission, thermochromic films may have an extremely well
865 defined capacity for digital regulation and thus may yield a more exact or controllable application of energy to target tissues. Organic and inorganic thermochromic materials tend to have a fast response time over a broad wavelength band and return to the transparent state when the LASER beam subsides. So, thermochromic materials may act more as a safety switch wherein, instead of having a separate sensor for temperature, a "fail-safe" mechanism would be to set
870 the thermochromic to shut down transmission if, using round numbers only, for example, the temperature of the thermochromic film exceeded 100 degrees centigrade depending upon the speed at which the TDM was moving. Other embodiments are contemplated in which the temperature threshold for limiting energy transmission ranges from about 65 to 90° C. In some such embodiments, the threshold may be between 68 to 75° C. Vanadium Dioxide (V02) as a
875 thermochromic film may see many potential uses, as it has such a rapid transition (in
femtoseconds) between the crystalline lattices of the metallic and semiconductor phase transition geometries. Regarding industrial use, for example, at temperatures below 69 centigrade V02 is a transparent semiconductor, but at just a few degrees higher, V02 may display its usefulness as a "reflective window coating." V02's rapid phase transition may see
880 usefulness in optical switches and even faster computer memory.
In alternative embodiments the geometry of the tip area may comprise protrusions that are not oriented along the axis of the shaft (as seen from a top view); some of these alternative embodiments for tip area geometries are depicted in Figures 5a,b,c,d,e,f,g,h and Figures 6a,b,c,d. Some embodiments may be configured to be modular and/or comprise disposable tips
885 such that a surgeon can place an appropriate tip for a particular surgery on the shaft.
Alternatively or additionally one or more of the tips may be disposable such that a surgeon may dispose of the tip after performing surgery and install a new tip for subsequent surgeries or a continuation of the current surgery with a new tip. In some embodiments, one or more suction/vacuum ports 217b may be provided on or
890 about the tip or distal shaft. The port(s) may be fluidly coupled with a vacuum; the vacuum may comprise a pump or a negative pressure chamber or a syringe at the end of a fluid conduit. Other embodiments may comprise one or more suction/vacuum ports on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft. In some embodiments, a fluid delivery port 216b may be provided. In some
895 embodiments the fluid delivery port may be coupled with a pump or high pressure fluid. In some embodiments the port may be perpetually open such that fluid may be delivered therethrough upon actuation of a pump or fluid pressure system. In other embodiments the port may be closed and selectively opened to deliver fluid therethrough. Other embodiments may comprise one or more fluid ports on any other suitable location on the TDM, including but not
900 limited to on the protrusions or otherwise on the tip, and on the shaft. Fluid ports that may be useful may comprise channels within the TDM, polymer lines, hoses, etc. Fluids that may emanate from the outlet may comprise ionic fluids such as saline, medicines (including but not limited to antibiotics, anesthetics, antineoplastic agents, bacteriostatic agents, etc.), non-ionic fluids, and or gasses (including but not limited to nitrogen, argon, air, etc.). In some
905 embodiments fluids may be under higher pressures or sprayed. It should be understood that although these elements (216b & 217b) are not depicted in every one of the other figures, any of the embodiments described herein may include one or more such elements.
In some embodiments, a vibration means 270b may be positioned in the handle. Other embodiments may comprise one or more vibration means on any other suitable location on the
910 TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft.
Examples of suitable vibration means may include piezoelectric materials, ultrasonic motors with stators, piezoelectric actuators, vibration motor such as an off-center weight mounted on a gear, etc. Some vibration means may be configured to emit ultrasound in the 20-40kHz range. Yet other vibration means may include electromagnet drivers with a frequency of operation in
915 the range of 150-400Hz. In some embodiments, one or more vibration means may be used to provide additional forces which may facilitate passage of the TDM. In some embodiments, one or more vibration means may be used to reduce debris on the electrosurgical or other components of the TDM. In a further embodiment, a vibration means may be directly or indirectly connected to one or more of the lysing elements.
920 In the depicted embodiment, 218b represents an antenna, such as an RFID TAG or
Bluetooth antenna. In embodiments in which antenna 218b comprises an RFID tag, the RFID tag may comprise an RFID transponder. In other embodiments the RFID tag may comprise a passive tag. It should be understood that antenna 218b is not depicted in every one of the other figures, any of the embodiments described herein may comprise one or more such elements.
925 Other embodiments may comprise one or more antennas on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft. In some embodiments an RFID transponder or another antenna may comprise a microchip, such as a microchip having a rewritable memory. In some embodiments, the tag may measure less than a few millimeters. In some embodiments a reader may generate an alternating
930 electromagnetic field which activates the antenna/RFID transponder and data may be sent via frequency modulation. In an embodiment, the position of the RFID tag or other antenna may be determined by an alternating electromagnetic field in the ultra-high frequency range. The position may be related to a 3 dimensional mapping of the subject. In an embodiment the reader may generate an alternating electromagnetic field. In some such embodiments, the
935 alternating electromagnetic field may be in the shortwave (13.56MHz) or UHF (865-869MHz) frequency.
In some embodiments tip 201 may be attached to a robotic arm. In some embodiments, tip 201 and portion of shaft 202 may be attached to a robotic arm. In some embodiments tip 201 and/or a portion of shaft 202 and/or a portion shaft and/or portion of handle 203 may be
940 attached to a robotic arm. In some embodiments, the robotic arm may comprise one or more motors such as a screw-drive motor, gear motor, hydraulic motors, etc. In some embodiments the robotic arm system may comprise worm gearheads, video cameras, motor control circuits, monitors, remote control devices, illumination sources, tactile interface, etc.
FIG. 2c depicts an embodiment of the thermochromic energy window embodiment
945 previously depicted in FIG. 2a. This depicted embodiment includes energy window 207, which is configured to comprise all or a portion of a thermochromic media 220, which is, in turn, substantially covered by a covering layer 221. In some embodiments, fiber optic 222 carries LASER energy derived from a LASER generator, into and through the handle, down the shaft and into the thermochromic media. In some embodiments, a wave guide may carry the LASER
950 energy down the shaft. In some embodiments, Vanadium Dioxide (V02) may be used as the inorganic thermochromic material and may be covered by a covering layer. In some embodiments, the Vanadium Dioxide layer is about 200-300 microns in thickness. In some embodiments, the Vanadium Dioxide layer ranges from about 10 microns to about 1000 microns. In some embodiments, the covering layer is silica. In some embodiments, the covering
955 layer comprises a transparent dielectric, quartz, alumina, sapphire, diamond, and/or ceramic. In some further embodiments, plastics may serve as a covering layer. In some embodiments, an Nd:YAG (neodymium yttrium, aluminum, garnet) LASER may energize the thermochromic media. In some embodiments, a Candela™ Gentle YAG™1064nm LASER is configured to energize a fiberoptic that thereupon leads into the TDM thermochromic window. In other
960 embodiments, Manganese Strontium Oxide may serve as the thermochromic layer. In some embodiments, diode LASERS may be used to energize the thermochromic material. In some embodiments, metal vapor LASERS and/or semiconductor-based LASERS may be used to energize the thermochromic material. Metal vapor LASERS may include, but are not limited to, copper vapor and gold vapor. The power source may be more helpful if it runs continuously but
965 is not too strongly absorbed to get the thermochromic effect when V02 changes in reflectivity.
Near-infrared LASERS may have some advantages over visible range LASERS in that contrast may be enhanced. In some embodiments, fiberoptics may carry the LASER energy. In some embodiments, a wave guide carries the LASER energy to the thermochromic film. In some embodiments, the thermochromic film may be configured to measure about 2x1 cm in
970 area. In some embodiments, the thermochromic film may be configured to deliver about
40J/cm2. In some embodiments, about 1 J/cm2 to about 200 J/cm2 may be delivered.
Some embodiments may comprise a tip comprising a plurality of protrusions and/or at least one lysing element positioned between each of the protrusions and/or a tip positioned at a distal end of the shaft, wherein the tip comprises a plurality of protrusions and at least one lysing
975 element positioned between at least two adjacent protrusions in the plurality of protrusions
and/or an energy window comprising a thermochromic media, wherein the thermochromic media is configured to absorb electromagnetic radiation energy and emit heat energy from the energy window, and wherein the energy window is positioned and configured to deliver the heat energy from the apparatus to tissue adjacent to the apparatus during an operation. Other
980 embodiments may further comprise a LASER that is configured to deliver energy to the
thermochromic media such that the thermochromic media can emit heat energy from the energy window. Still other embodiments may comprise a fiber optic cable configured to deliver LASER energy to the thermochromic media. In some embodiments the thermochromic media may be configured such that the temperature of the energy window cannot exceed a threshold
985 temperature. In some embodiments at least one lysing element may comprise at least one lysing segment.
FIG. 3a is a perspective view of an embodiment of a tissue dissector and modifier with a target-tissue-impedance-matched-microwave-based energy window on the upper side of the device. A target-tissue-impedance-matched-microwave emission system (TTIMMES) may be
990 advantageous over previously available microwave based medical treatment systems because it is difficult to model tissue against water because the dielectric associated with water differs from that of blood, which differs from that of tissue, and so on, especially after coagulum formation. Both non-impedance-matched-microwave and radiofrequency treatments may suffer from this concern. Beneficially for microwaves there is limited coagulum formation, and deeper
995 penetration of energy into the tissues. With impedance matching, energy is not reflected back from the tissues into the microwave emitting antennae as the energy proceeds uni-directionally through the coaxial cable and into the target tissue. A controllable solid state source (e.g., MicroBlate™) of a super-high frequency (SHF) microwave emission band of 14.5GHz system that is impedance matched has been shown to produce a depth of penetration of about 1.6mm 1000 using coaxial antennae measuring just 2.2mm (Int'l Journal of Hyperthermia 28: 43-54, 2012).
FIG. 3a is a perspective view of an embodiment of a TDM with an alternative energy window 307 on the upper side of the device configured to hold an array of impedance-matched- microwave emitting antennae. It should be noted that the term "energy window" is intended to encompass what is referred to as a planar-tissue-altering-window/zone in U.S. Patent No.
1005 7,494,488 and, as described herein, need not contain a microwave emitter in all embodiments.
Additionally, the "energy window" may comprise a variety of other energy emitting devices, including radiofrequency, intense pulsed light, LASER, thermal, and ultrasonic. It should also be understood that the term "energy window" does not necessarily imply that energy is delivered uniformly throughout the region comprising the energy window. Instead, some energy window
1010 implementations may comprise a series of termini or other regions within which energy is
delivered with interspersed regions within which no energy, or less energy, is delivered. This configuration may be useful for some implementations to allow for alteration of certain tissue areas with interspersed areas within which tissue is not altered, or at least is less altered. This may have some advantages for certain applications due to the way in which such tissue heals. It
1015 is contemplated that in alternative embodiments, impedance-matched-microwave energy
window 307 may be omitted.
FIG. 3a is a perspective view of an embodiment of a TDM comprising a tip 301 , a shaft 302 and a handle 303. Electrosurgical energy may be delivered in conduits 311 and/or 312, whereas gigahertz microwave energy may be delivered by coaxial cable bundle 322 through the
1020 handle and shaft to energy window 307, which may comprise four antennae termini. Some embodiments comprise between 1 and 10 antennae. Some embodiments may comprise a flat microwave emitting device. A second energy window 308 may also be included in some embodiments, and may comprise yet another microwave emitter or another variety of energy emitting device. Electro-cutting and electro-coagulation currents may be controlled outside the
1025 TDM at an electrosurgical generator, such as the Bovie Aaron 1250™ or Bovie Icon GP™. In some embodiments, the tip may measure about 1cm in width and about 1-2 mm in thickness. Sizes of about one-fifth to about five times these dimensions may also have possible uses. In some veterinary embodiments, tip sizes of about one-tenth to 20 times the aforementioned dimensions may also have possible uses.
1030 In some embodiments, the tip can be a separate piece that may be secured to a shaft by a variety of methods, such as a snap mechanism, mating grooves, plastic sonic welding, etc. Alternatively, in some other embodiments, the tip can be integral or a continuation of a shaft made of similar metal(s) or material(s). In some embodiments, the tip may also be constructed of materials that are both electrically non-conductive and of low thermal conductivity; such
1035 materials might comprise, for example, porcelain, ceramics, glass-ceramics, plastics, varieties of polytetrafluoroethylene, carbon, graphite, and graphite-fiberglass composites. In some embodiments, the tip may be constructed of a support matrix of an insulating material (e.g., ceramic or glass material such as alumina, zirconia). Conduit 311 may connect to electrically conductive elements to bring RF electrosurgical energy from an electrosurgical
1040 generator down the shaft 302 to electrically conductive lysing elements 305 mounted in the recessions in between protrusions 304. In some embodiments, the protrusions may comprise bulbous protrusions. In the depicted embodiment, the tip 301 may alternatively be made partially or completely of concentrically laminated or annealed-in wafer layers of materials that may include plastics, silicon, glass, glass/ceramics or ceramics. Alternatively, in a further
1045 embodiment, the tip may be constructed of insulation covered metals or electroconductive
materials. In some embodiments, the shaft may be flat, rectangular, or geometric in cross- section, or may be substantially flattened. In some embodiments, smoothing of the edges of the shaft may reduce friction on the tissues surrounding the entrance wound. In some further embodiments, the shaft may be made of metal or plastic or other material with a completely
1050 occupied or hollow interior that can contain insulated wires, electrical conductors, fluid/gas pumping or suctioning conduits, fiber-optics, or insulation.
In some embodiments, shaft plastics, such as polytetrafluoroethylene may act as insulation about wire or electrically conductive elements. In some embodiments, the shaft may
alternatively be made partially or completely of concentrically laminated or annealed-in wafer
1055 layers of materials that may include plastics, silicon, glass, glass/ceramics, ceramics carbon, graphite, graphite-fiberglass composites. Depending upon the intended uses for the device, an electrically conductive element internal to shaft may be provided to conduct electrical impulses or RF signals from an external power/control unit (such as a Valleylab™ electrosurgical generator) to another energy window 308. In some embodiments, energy windows 307 and/or
1060 308 may only be substantially planar, or may take on other cross-sectional shapes that may correspond with a portion of the shape of the shaft, such as arced, stair-step, or other geometric shapes/curvatures. In some embodiments, energy window 308 may comprise another microwave emitter. In the embodiments depicted in FIGS. 3a & 3b, energy window 307 is adjacent to protrusions 304, however other embodiments are contemplated in which an energy
1065 window may be positioned elsewhere on the shaft 302 or tip 301 of the wand, and still be
considered adjacent to protrusions 304. For example, in an embodiment lacking energy window 307, but still comprising energy window 308, energy window 308 would still be considered adjacent to protrusion 304. However, if an energy window was placed on handle 303, such an energy window would not be considered adjacent to the protrusions 304.
1070 The conduit(s) may also contain electrical control wires to aid in device operation. Partially hidden from direct view in FIGS. 3a & 3b, and located in the recessions defined by protrusions 304, are electrically conductive tissue lysing elements 305, which, when powered by an electrosurgical generator, effects lysing of tissue planes on forward motion of the device. The lysing elements may be located at the termini of conductive elements.
1075 In some embodiments, one or more sensors such as for example sensors 310 and 314 may be positioned on the device. The sensors 310 and 314 may comprise any of the sensors described in the specification herein. Other embodiments may comprise one or more sensors on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft. Sensors that may be useful include thermal sensors,
1080 photoelectric or photo optic sensors, cameras, etc. In some embodiments, one or more sensors may be used to monitor the local post passage electrical impedance or thermal conditions that may exist near the distal tip of the shaft or on the tip. Some embodiments may also comprise one or more sensors incorporating MEMS (Micro Electro-Mechanical Systems) technology, such as MEMS gyroscopes, accelerometers, and the like. Such sensors may be positioned at
1085 any number of locations on the TDM, including within the handle in some embodiments. In some embodiments, sensor 314 may comprise fiberoptic elements. In an embodiment, the sensor can be configured to sense a temperature of tissue adjacent to the apparatus during one or methods described herein. The temperature sensor may alternatively be configured or sense a temperature of one or more fluids adjacent to the apparatus such as for example tissue fluids
1090 and/or fluids introduced by the surgeon.
Temperature and impedance values may be tracked on a display screen or directly linked to a microprocessor capable of signaling control electronics to alter the energy delivered to the tip when preset values are approached or exceeded. Typical instrumentation paths are widely known, such as thermal sensing thermistors, and may feed to analog amplifiers which, in turn,
1095 feed analog digital converters leading to a microprocessor. In some embodiments, internal or external ultrasound measurements may also provide information which may be incorporated into a feedback circuit. In an embodiment, an optional mid and low frequency ultrasound transducer may also be activated to transmit energy to the tip and provide additional heating and may additionally improve lysing. In some embodiments, a flashing visible light source, for
1100 example, an LED, can be mounted on the tip may show through the tissues and/or organs to identify the location of the device.
In some embodiments, one or more electromagnetic delivery elements 315 may be positioned on tip or shaft. Other embodiments may comprise one or more electromagnetic delivery elements on any other suitable location on the TDM, including but not limited to on the
1105 protrusions or otherwise on the tip, and on the shaft. Electromagnetic delivery elements that may be useful include: LEDs, LASERS, fiberoptics, filaments, photoelectric materials, infrared emitters, etc.
Alternatively, in some embodiments, since cutting or electrical current may cause an effect at a distance without direct contact, the lysing element may be recessed into the relative 1110 recessions or grooves defined by the protrusions 304 or, alternatively, may be flush with protrusions 304. In some further adjustable embodiments, locations of the electrically conductive lysing elements with respect to the protrusions may be adjusted by diminutive screws or ratchets. In some further adjustable embodiments, locations of the electrically conductive lysing elements with respect to the protrusions may be adjusted by MEMS or
1115 microelectronics.
In some embodiments, the electrically conductive lysing element may also exist in the shape of a simple wire of 0.1 mm and 1 mm 0.01 mm to 3mm. In some embodiments, the wire may measure betweenO.OI mm to 3mm. Such a wire may be singly or doubly insulated as was described for the plate and may have the same electrical continuities as was discussed for the
1120 planar (plate) version. In some embodiments, an electrosurgical current for the electrically
conductive lysing element is of the monopolar "cutting" variety and setting and may be delivered to the tip lysing conductor in a continuous fashion or, alternatively, a pulsed fashion. The surgeon can control the presence of current by a foot pedal control of the electrosurgical generator or by button control on the shaft (forward facing button). The amount of cutting current
1125 may be modified by standard interfaces or dials on the electrosurgical generator. In some
embodiments, the electrosurgically energized tip current can be further pulsed at varying rates, by interpolating gating circuitry at some point external to the electrosurgical generator by standard mechanisms known in the art, that may range from about 1 per second to about 60 per second. In some embodiments, the rate may vary from about 1 per second to about 150 per
1130 second. In some embodiments, the electrosurgically energized tip current can be further pulsed at varying rates by gating circuitry within the electrosurgical generator by standard mechanisms known in the art.
In alternative embodiments the geometry of the tip area may comprise protrusions that are not oriented along the axis of the shaft (as seen from a top view); some of these alternative
1135 embodiments for tip area geometries are depicted in Figures 5a,b,c,d,e,f,g,h and Figures
6a,b,c,d. Some embodiments may be configured to be modular and/or comprise disposable tips such that a surgeon can place an appropriate tip for a particular surgery on the shaft.
Alternatively or additionally one or more of the tips may be disposable such that a surgeon may dispose of the tip after performing surgery and install a new tip for subsequent surgeries or a
1140 continuation of the current surgery with a new tip.
In some embodiments, one or more suction/vacuum ports 317b may be provided on or about the tip or distal shaft. The port(s) may be fluidly coupled with a vacuum; the vacuum may comprise a pump or a negative pressure chamber or a syringe at the end of a fluid conduit. Other embodiments may comprise one or more suction/vacuum ports on any other suitable
1145 location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft. In some embodiments, a fluid delivery port 316b may be provided. In some embodiments the fluid delivery port may be coupled with a pump or high pressure fluid. In some embodiments the port may be perpetually open such that fluid may be delivered therethrough upon actuation of a pump or fluid pressure system. In other embodiments the port
1150 may be closed and selectively opened to deliver fluid therethrough. Other embodiments may comprise one or more fluid ports on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft. Fluid ports that may be useful may comprise channels within the TDM, polymer lines, hoses, etc. Fluids that may emanate from the outlet may comprise ionic fluids such as saline, medicines (including but not
1155 limited to antibiotics, anesthetics, antineoplastic agents, bacteriostatic agents, etc.), non-ionic fluids, and or gasses (including but not limited to nitrogen, argon, air, etc.). In some
embodiments fluids may be under higher pressures or sprayed. It should be understood that although these elements (316b & 317b) are not depicted in every one of the other figures, any of the embodiments described herein may include one or more such elements.
1160 In some embodiments, a vibration means 370b may be positioned in the handle. Other embodiments may comprise one or more vibration means on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft. Examples of suitable vibration means may include piezoelectric materials, ultrasonic motors with stators, piezoelectric actuators, vibration motor such as an off-center weight mounted on a
1165 gear, etc. Some vibration means may be configured to emit ultrasound in the 20-40kHz range.
Yet other vibration means may include electromagnet drivers with a frequency of operation in the range of 150-400Hz. In some embodiments, one or more vibration means may be used to provide additional forces which may facilitate passage of the TDM. In some embodiments, one or more vibration means may be used to reduce debris on the electrosurgical or other
1170 components of the TDM. In a further embodiment, a vibration means may be directly or
indirectly connected to one or more of the lysing elements.
In the depicted embodiment, 318b represents an antenna, such as an RFID TAG. In embodiments in which antenna 318b comprises an RFID tag, the RFID tag may comprise an RFID transponder. In other embodiments the RFID tag may comprise a passive tag. It should
1175 be understood that antenna 318b is not depicted in every one of the other figures, however, any of the embodiments described herein may comprise one or more such elements. Other embodiments may comprise one or more antennas on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft. In some embodiments an RFID transponder or another antenna may comprise a microchip, such as a
1180 microchip having a rewritable memory. In some embodiments, the tag may measure less than a few millimeters. In some embodiments a reader may generate an alternating electromagnetic field which activates the RFID transponder/antenna and data may be sent via frequency modulation. In an embodiment, the position of the RFID tag/antenna may be determined by an alternating electromagnetic field in the ultra-high frequency range. The position may be related 1185 to a 3 dimensional mapping of the subject. In an embodiment the reader may generate an alternating electromagnetic field. In some such embodiments, the alternating electromagnetic field may be in the shortwave (13.56MHz) or UHF (865-869MHz) frequency.
In some embodiments tip 301 may be attached to a robotic arm. In some embodiments, tip 301 and portion of shaft 302 may be attached to a robotic arm. In some embodiments tip 301
1190 and/or a portion of shaft 302 and/or a portion shaft and/or portion of handle 303 may be
attached to a robotic arm. In some embodiments, the robotic arm may comprise one or more motors such as a screw-drive motor, gear motor, hydraulic motors, etc. In some embodiments the robotic arm system may comprise worm gearheads, video cameras, motor control circuits, monitors, remote control devices, illumination sources, tactile interface, etc.
1195 FIG. 3c depicts an embodiment of the target-tissue-impedance-matched-microwave-based emission system (TTIMMES) previously depicted in FIG. 3a. This depicted embodiment includes energy window 307, which is configured to comprise a bundle of microwave antennae 322a further comprising singular antennae, such as 320 and 321. Coaxial cable bundle 322 carries gigahertz microwave energy derived from a super high frequency (SHF) generator, into
1200 and through the handle, down the shaft and into the coaxial antennae. In some embodiments, a flat microwave emitter may be placed in energy window 307. In some embodiments, flat microwave emission devices are comprised of a "microstrip" in which an antenna is printed on a circuit board. In some embodiments, the circuitboard may be coated with polytetrafluroethylene, and may be seated on an alumina substrate.
1205 In some embodiments, a controllable solid state source (N5183A MXG Microwave Analog Signal Generator from Agilent Technologies™) of a super-high frequency (SHF) microwave emission band of 36GHz system that is impedance matched drives the coaxial cables to emit microwaves.
Additionally, an "energy window" may comprise a variety of other energy emitting devices, 1210 including radiofrequency, microwave, filament, light, intense pulsed light, LASER, thermal, and ultrasonic. A second energy window 308 may also be included in some embodiments, and may comprise yet another microwave or another variety of energy emitting device.
Some embodiments of the energy window may also comprise one or more LASERS that may also be used through the fiberoptic and may be controlled at the electromagnetic energy 1215 source by a footswitch. In some embodiments, the planar tissue-altering-window/zone may be an optical window that allows laser light to exit the shaft and irradiate nearby target tissue. In some embodiments, a light delivery means, which can be a hollow waveguide or single or multiple optical fibers (such as metal coated plastic manufactured by Polymicro Technologies™, Inc. of Phoenix, Ariz.) may be contained in an external conduit. The external conduit may 1220 comprise, for example an articulating arm as is commonly used in surgical laser systems.
Additional control wires and power may be delivered to the handpiece via the external conduit. However, using foot-pedal control from an electromagnetic energy radiation source or control interface, dial, or panel will likely be less cumbersome for the surgeon and reduce the expense of handpiece finger-control manufacture.
1225 Some embodiments may use an energy window comprising Germanium, which may allow for egress of laser light and collection of data by thermal sensors, and such energy window may be of varying size. In another embodiment, a multiplicity of optical fibers may terminate at specific or random places within the energy window. Such bare or coated fiberoptic termini may protrude from, be flush with, or be recessed into, other materials comprising the energy window.
1230 Such bare or coated fiberoptic termini may protrude from, be flush with or be recessed into other materials comprising the energy window. In some embodiments, bare fiberoptics comprising ethylene oxide sterilizable may be seated in a thermally nonconductive background, preferably at uniform 90 degree angles, but variable angles between 0 and 180 degrees may also be efficacious. The preferred light delivery means may depend on the wavelength of the laser
1235 used. Infrared light emitted by the heated tissue can also be collected through the window and sensed by an infrared detector to measure the tissue temperature. For C02 laser irradiance, reliable sources include standard operating room units, such as the Encore Ultrapulse® from Lumenis Corp. of Santa Clara, Calif., which is capable of providing continuous C02 laser energy outputs of 2-22mJoules at 1-60 Watts. Older models of the Coherent Ultrapulse™ may also be
1240 suitable (Coherent™ now owned by Lumenis™).
In some embodiments, a hollow section of shaft may act as a waveguide or may contain a metal-coated plastic fiberoptic or waveguide to allow laser light to pass through and exit from window near tip. The window may allow egress for laser light delivered to apparatus. In some embodiments, Lasers may include both pulsed and continuous wave lasers, such as C02,
1245 erbium YAG, Nd:YAG and Yf:YAG. The beam diameter may be changed as desired, as those skilled in the art will appreciate. However, this list is not intended to be self-limiting and other wavelength lasers may be used.
Some embodiments of the energy window may comprise an intense, pulsed, non-coherent, non-LASER, such as a filtered flashlamp that emits a broadband of visible light. The flashlamp,
1250 such as a smaller version of that used by ESC/Sharplan™, Norwood, Mass. (500-1200 nm
emission range; 50 J/sqcm fluence; 4 ms pulse; 550 nm filter) may occupy the handle or window/zone of the embodiment. In some embodiments, a flashlamp may emit optical and thermal radiation that can directly exit the energy window, or may be reflected off a reflector to exit through the window. In an embodiment, a reflector may have a parabolic shape to
1255 effectively collect radiation emitted away from the window, which may be made of a wide variety of glass that transmits optical, near infrared, and infrared light (e.g., quartz, fused silica and germanium.) Emission spectra may be filtered to achieve the desired effects. Thermal emissions or visible radiation absorption may locally heat the dermis to alter collagen. Thermal sensors may also be used to control or reduce overheating. In order to eliminate excessive
1260 heating of the shaft and the surrounding facial tissue, the flashlamp and reflector may be
thermally isolated by low thermal conductivity materials or cold nitrogen gas that may be pumped through a hollow or recessed portion of the shaft and/or handle. In an embodiment, the handle can be an alternative location for the flashlamp so that emitted radiation may be reflected by a mirror through the window/zone.
1265 In some embodiments, direct piezoelectric versions of the energy window may impart
vibrational energy to water molecules contained in target tissues passing adjacent to the piezo material(s). Temperature elevations may cause collagenous change and cell wall damage, however, ultrasonic energy application may have disruptive effects at the subcellular level as well. Energy output for piezoelectric window/zones may typically range from about 1-30 J; in an
1270 embodiment, an energy output range of about 1-6 J may occur in a surgical device moving about 1 cm/second. In an embodiment, temperature and impedance sensors may provide
intraoperative real-time data can modulate energy input into the piezoelectric, which may be energized by one or more conductive elements in the shaft in further connection with the control unit and/or power supply. In some embodiments, the energy window for a thermally energized
1275 embodiment may allow thermal energy to escape from within the shaft, and wherein the tip can be integral or a continuation of shaft made of similar metal or materials. The tip may also be constructed of materials that are both electrically non-conductive and of low thermal
conductivity; such materials might be porcelain, ceramics or plastics. Portions of the tip and shaft may be covered with Teflon® to facilitate smooth movement. Teflon® may also be used
1280 to coat portions of an antenna, such as a microwave antenna, such that the energy is delivered in a more uniform fashion.
In some embodiments, a filament may be fixedly attached to the shaft. The hot filament may emit optical and thermal radiation that can directly exit the energy window or be reflected off a reflector to also exit through window. The reflector may have a parabolic shape to effectively
1285 collect all optical and thermal radiation emitted away from the window. In some embodiments, a hot filament can be a tungsten carbide filament similar to those used in high power light bulbs. The wavelength may be adjusted and controlled by adjusting the filament temperature/current. In some embodiments, the window may be selected from a wide variety of glass that transmits optical, near infrared and infrared light (e.g., quartz, fused silica and germanium.) The tissue
1290 penetration depth may depend on the wavelength of the light (e.g., 1 μηι may penetrate through about 10 mm, 10 μηι may penetrate through about 0.02 mm). In an embodiment, the broad emission spectrum from the hot filament may be filtered to achieve the desired tissue effect. In some embodiments, thermal sensors connected to the control unit by electrical wire may be used to monitor the temperature of tissue that is in contact with the shaft. In order to eliminate
1295 excessive heating of the shaft and the surrounding facial tissue, the heating element and/or reflector may be thermally isolated by low thermal conductivity materials. The heating element may be isolated by reducing contact with the shaft, whereas the reflector may have an isolating layer where it attaches to the shaft. In an embodiment, cold nitrogen gas may be injected through tube and pumped out through the hollow shaft to cool the tip and shaft.
1300 In some embodiments, the hot filament may be placed in the handle while emitted optical and thermal radiation is reflected off a mirror through the window. An alternative embodiment may allow for tissue heating to be achieved by direct contact with a hot surface where electric current flowing through wires heats a resistive load made of single or multiple elements to a user selected temperature. The resistive load could be a thin film resistor and the film
1305 temperature could be estimated from the measured resistance. In some embodiments,
separate thermal sensors placed close to the heating element may be used to measure temperatures, which may be sent to a control unit to control the current through the resistive load. Cold gas or liquid(s) can be injected through tubes and pumped out through the shaft. In an embodiment, the heating element could be the hot side of a Peltier thermoelectric cooler
1310 which advantageously cools the opposite surface below ambient temperature with differences of up to about 40° C. In some thermal embodiments, heat may be derived via magnetic or frictional methods to bring about similar tissue alterations.
It has been discovered that some embodiments may also be effective without means for and energy window. For example, in some embodiments lacking an energy window, energy
1315 delivered by or otherwise at the lysing elements may be sufficient to at least partially induce fibrosis within a target region as the tissue is separated. In some embodiments and
implementations it may therefore be useful to provide a higher energy such a higher level of electrosurgical energy (for example current flow). In some embodiments and implementations, the energy at the lysing elements may be increased beyond what would otherwise be needed
1320 just to separate tissue into planes. Although in some embodiments, one may be able to induce target tissue fibrosis by using only the requisite energy needed to separate tissue. In other embodiments, energy may be increased (such as an increase of 5% to 500%) to increase the probability of inducing target tissue fibrosis without the use of an energy window. In other embodiments, energy may be increased (such as an increase of 5% to 150%) to increase the
1325 probability of target tissue fibrosis without the use of an energy window In other embodiments, energy may be increased (such as an increase of 10% to 30%) to increase the probability of target tissue fibrosis without the use of an energy window.
Some embodiments may comprise a tip comprising a plurality of protrusions and/or at least one lysing element positioned between each of the protrusions and/or an energy window
1330 comprising a target-tissue-impedance-matched-microwave based energy window, wherein the target-tissue-impedance-matched-microwave based energy window is positioned and configured to deliver microwave energy from the apparatus to incapacitate eccrine glands within a target region of a patient's skin. In an embodiment the energy window may comprise an array of impedance-matched-microwave emitting antennae. Another embodiment may comprise a
1335 sensor for receiving and delivering information to a user. In some embodiments the sensor comprises at least one of a thermal sensor, a photoelectric sensor, a photo-optic sensor, a camera, and a MEMS sensor. In some embodiments, the at least one lysing element may comprise at least one lysing segment.
In another embodiment depicted in Figure 4, the electrical wiring for the TDM comprises a
1340 connector 4100, a two-conductor cable 4120, a SPDT (Single-Pole, Double-Throw) switch 4145, a shaft 4175 with three conductors, a first electrode 4185 that may be used for tissue
modification and/or coagulation ("COAG electrode"), a second electrode 4190 that may be used for cutting tissue and/or tissue coagulation ("CUT electrode"), and a third electrode 4195 ("return electrode"). The two-conductor cable 4120 is comprised of RF conductor one 4130 and RF
1345 conductor two 4135. RF conductor one 4130 extends from RF pin one 4110, positioned in the connector 4100, to the Switch RF pin 4150 of the SPDT switch 4145 which may be positioned in the handle 4140. The COAG electrode conductor 4176 positioned in the shaft 4175 extends from the COAG electrode 4185 may be positioned in the tip 4180, to the COAG electrode pin 4155 of the SPDT switch 4145. The CUT electrode conductor 4177, positioned in the shaft
1350 4175, extends from the CUT electrode 4190 positioned in the tip 4180, to the CUT electrode pin
4160 of the SPDT switch 4145. The RF conductor two 4135, starting in the connector 4100, extends from RF pin two 4115 that may be positioned in the connector 4100 or within another connector plugged into the electrosurgical generator, to the return electrode 4195 positioned in the tip 4180 or on the shaft 4175. The SPDT switch 4145 can be manipulated between two
1355 positions. In one switch position the switch RF pin 4150 may be electrically short circuited to the COAG electrode pin 4155. In the other switch position, the RF pin 4150 may be electrically short circuited to the CUT electrode pin 4160. This embodiment requires the use of a foot switch (such as the Valley Lab Bipolar Footswitch, E6008) in conjunction with an electrosurgical generator (ESU) to activate/deactivate the RF energy delivered to the TDM. This embodiment
1360 allows RF energy from the ESU to be delivered to the CUT electrode 4190 or the COAG
electrode 4185 depending on the selected SPDT switch 4145 position. If the footswitch is engaged, electric current is able to flow between the selected electrode (CUT electrode 4190 or COAG electrode 4185) and the return electrode 4195, provided the return electrode 4195 and one of the other electrodes both make physical contact with a contiguous, electrically conductive
1365 material (As well, plasma generation may extend the reach of the CUT or COAG electrode to effectively enable contact with the contiguous, electrically conductive material). In this embodiment, the TDM may be utilized as a bipolar device with a selectable electrode
configuration. In some embodiments, the surface area that comprises the return electrode 4195 which makes contact with the electrically conductive material is optimally chosen to minimize 1370 the current density with the objective of minimizing the heating on the surface of the return electrode 4195. In other embodiments, the conductor cable 4120 comprises more than two conductors to accommodate other attributes of the device. In other embodiments, the SPDT switch 4145 may be positioned on the conductor cabling 4120 between the connector 4100 and the handle 4140; in such embodiments the electrode conductors 4176 and 4177 leading to the
1375 electrodes 4185 and 4190 may extend through or around the shaft 4175 and handle 4140 and may comprise at least part of conductor cabling 4120. In other embodiments, the shaft 4175 may contain more than 3 conductors. In alternative embodiments, each conductor within the conductor cable 4120 may be contained in its own cabling. In an alternative embodiment, the switch 4145 may have more than 2 positions.
1380 Some embodiments may comprise a tip further comprising a plurality of protrusions and/or at least one lysing element positioned between each of the protrusions and/or a tip positioned at a distal end of the shaft, wherein the tip comprises a plurality of protrusions and at least one lysing element positioned between at least two adjacent protrusions in the plurality of protrusions. In an embodiment, a lysing element may be configured to emit electromagnetic
1385 energy. In an embodiment, electromagnetic energy may comprise a bipolar radiofrequency electrosurgical current.
FIG. 5a is an upper plan view illustrating the protrusions and lysing elements of an embodiment of a tissue dissector and modifier, wherein some of the protrusions and lysing elements are oriented in a non-axial direction and the non-axial protrusions do not extend
1390 beyond the width of the distal shaft (and the axis of comparison is that of the shaft as seen from a top view). In some embodiments, the tip may measure about 1 cm in width and about 1-2 mm in thickness. Sizes of about one-fifth to about five times these dimensions may also have possible uses.
In the embodiment depicted in FIG. 5a, the non-axial protrusions 551a of tip 501 a do not 1395 extend beyond the width of the distal shaft 502a, which leads to handle 503a. In this
embodiment, non-axial protrusions 551 a extend in a direction that is at least substantially perpendicular to the direction in which axial protrusions 504a extend. More particularly, there are two sets of non-axial protrusions 551 a (one depicted on the right side and one on the left side of the embodiment of FIG. 5a). Both sets of non-axial protrusions 551a extend in directions 1400 that are at least substantially perpendicular to the direction in which axial protrusions 504a
extend (namely, along a longitudinal axis of the TDM shaft). In addition, it can be seen in FIG. 5a that the two sets of non-axial protrusions 551a extend in directions that are at least substantially opposite from one another.
In some embodiments, axial protrusions 504a may extend at least substantially along a 1405 longitudinal axis of the shaft, as described above, and non-axial protrusions 551 a may extend at an angle of between zero degrees and 30 degrees of a normal to the direction in which the axial protrusions 504a extend. It is contemplated that it may desirable for some implementations and embodiments to provide non-axial tips extending in a direction or directions falling within this range in order to, for example, allow a surgeon to effectively perform both a to and fro, and a
1410 side-to-side ("windshield wiper") motion using the TDM.
In some embodiments, the tip can be a separate piece that is secured to the shaft by a variety of methods such as a snap mechanism, mating grooves, plastic sonic welding, etc.
Alternatively, in some other embodiments, the tip can be integral or a continuation of a shaft made of similar metal or materials. In some embodiments, the tip may also be constructed of
1415 materials that are both electrically non-conductive and of low thermal conductivity; such
materials might comprise, for example, porcelain, ceramics, glass-ceramics, plastics, varieties of polytetrafiuoroethyiene, carbon, graphite, and graphite-fiberglass composites. In some embodiments, the tip may be constructed of a support matrix of an insulating material (e.g., ceramic or glass material such as alumina, zirconia). External power control bundles as
1420 previously described in other embodiments may connect to electrically conductive elements to bring RF electrosurgical energy from an electrosurgical generator down the shaft 502a to electrically conductive lysing elements 552a mounted in the recessions in between the protrusions 551a. In some embodiments, the protrusions may comprise bulbous protrusions. The tip shown in this embodiment has two relative protrusions and three relative recessions
1425 pointing along the main axis of the TDM and provides for a monopolar tip conductive element; the tip shown also has fourteen protrusions pointing in non-axial directions as well as fourteen relative recessions pointing in non-axial directions. In other embodiments the tip may have one or more non-axial protrusions and one or more non-axial relative recessions. In some embodiments the tip may have between 3 and 100 non-axial protrusions and relative
1430 recessions. In the depicted embodiment, the tip 501a may alternatively be made partially or completely of concentrically laminated or annealed-in wafer layers of materials that may include plastics, silicon, glass, glass/ceramics, cermets or ceramics. Lysing elements 552a may also be made partially or completely of a cermet material. Alternatively, in a further embodiment the tip may be constructed of insulation covered metals or electroconductive materials. The lysing
1435 elements may be located at the termini of conductive elements.
In the depicted embodiment, tip 501a which terminates in protrusions such as 504a and 551a may be made of materials that are both electrically non-conductive and of low thermal conductivity such as porcelain, epoxies, ceramics, glass-ceramics, plastics, or varieties of polytetrafiuoroethyiene. Alternatively, the tip may be made from metals or electroconductive
1440 materials that are completely or partially insulated. In some embodiments, the electrically
conductive tissue lysing element(s) 552a may have any geometric shape including a thin cylindrical wire, and may be positioned within the relative recessions of the tip. The electrically conductive lysing element can be in the shape of a plate or plane or wire and made of any metal or alloy that does not melt under operating conditions or give off toxic residua. Optimal
1445 materials may include but are not limited to steel, nickel, alloys, palladium, gold, tungsten, silver, copper, and platinum. Metals may become oxidized thus impeding electrical flow and function.
In some embodiments, the shaft may be flat, rectangular or geometric in cross-section and/or substantially flattened. In some embodiments, smoothing of the edges of the shaft may reduce friction on the tissues surrounding the entrance wound. In some further embodiments,
1450 the shaft may be made of metal or plastic or other material with a completely occupied or hollow interior that can contain insulated wires, electrical conductors, fluid/gas pumping or suctioning conduits, fiber-optics, or insulation.
In some embodiments, shaft plastics, such as polytetrafiuoroethy!ene, may act as insulation about wire or electrically conductive elements. In some embodiments, the shaft may
1455 alternatively be made partially or completely of concentrically laminated or annealed-in wafer layers of materials that may include plastics, silicon, glass, glass/ceramics, ceramics carbon, graphite, and/or graphite-fiberglass composites.
In FIG. 5a the depicted view of an embodiment of a TDM with an alternative energy window 507a on the upper side of the device may be configured to hold an ultrasound energy emitter. It
1460 should be noted that the term "energy window" is intended to encompass what is referred to as a planar-tissue-altering-window/zone in U.S. Patent No. 7,494,488 and, as described herein, need not contain a ultrasonic energy emitter in all embodiments. Additionally, the "energy window" may comprise a variety of other energy emitting devices, including but not limited to radiofrequency, microwave, light, intense pulsed light, LASER, and thermal. Certain
1465 components of the energy window, such as the electro-conductive components of the energy window, could comprise a cermet. A second energy window 508a may also be included in some embodiments, and may comprise yet another ultrasonic energy emitter or another variety of energy emitting device. In some embodiments, energy windows 507a and/or 508a may only be substantially planar, or may take on other cross-sectional shapes that may correspond with a
1470 portion of the shape of the shaft, such as arced, stair-step, or other geometric
shapes/curvatures. In the embodiment depicted in FIG. 5a, energy window 507a is adjacent to protrusions 504a and 551 a, however other embodiments are contemplated in which an energy window may be positioned elsewhere on the shaft 502a or tip 501 a of the wand, and still be considered adjacent to protrusions 504a or 551a. For example, in an embodiment lacking
1475 energy window 507a, but still comprising energy window 508a, energy window 508a would still be considered adjacent to protrusions 504a and 551a. However, if an energy window was placed on handle 503a, such an energy window would not be considered adjacent to
protrusions 504a or 551a.
In some embodiments, one or more sensors such as for example sensors 510a and 514a
1480 may be positioned on the device. The sensors 510a and 514a may comprise any of the sensors described in the specification herein. Other embodiments may comprise one or more sensors on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft. Sensors that may be useful include thermal sensors, photoelectric or photo optic sensors, cameras, etc. In some embodiments,
1485 one or more sensors may be used to monitor the local post passage electrical impedance or thermal conditions that may exist near the distal tip of the shaft or on the tip. Some
embodiments may also comprise one or more sensors incorporating MEMS (Micro Electro- Mechanical Systems) technology, such as MEMS gyroscopes, accelerometers, and the like. Such sensors may be positioned at any number of locations on the TDM, including within the
1490 handle in some embodiments. In some embodiments, sensor 514a may comprise fiberoptic elements. In an embodiment, the sensor can be configured to sense a temperature of tissue adjacent to the apparatus during one or methods described herein. The temperature sensor may alternatively be configured or sense a temperature of one or more fluids adjacent to the apparatus such as for example tissue fluids and/or fluids introduced by the surgeon.
1495 Temperature and impedance values may be tracked on a display screen or directly linked to a microprocessor capable of signaling control electronics to alter the energy delivered to the tip when preset values are approached or exceeded. Typical instrumentation paths are widely known, such as thermal sensing thermistors, and may feed to analog amplifiers which, in turn, feed analog digital converters leading to a microprocessor. In some embodiments, internal or
1500 external ultrasound measurements may also be taken during a procedure with the TDM.
Sensors that may be useful include thermal sensors, photoelectric or photo optic sensors, cameras, etc. Temperature sensors that may be useful in connection with embodiments disclosed herein include, but are not limited to, resistance temperature sensors, such as carbon resistors, film thermometers, wire-wound thermometers, or coil elements. Some embodiments
1505 may comprise thermocouples, pyrometers, or non-contact temperature sensors, such as total radiation or photoelectric sensors.
In some embodiments, one or more electromagnetic delivery elements 515a may be positioned on tip or shaft. Other embodiments may comprise one or more electromagnetic delivery elements on any other suitable location on the TDM, including but not limited to on the
1510 protrusions or otherwise on the tip, and on the shaft. Electromagnetic delivery elements that may be useful include: LEDs, LASERS, fiberoptics, filaments, photoelectric materials, infrared emitters, etc.
In embodiments of tips with at least some non-axial placement of protrusion and or relative recessions, surgeons may implement the use of a fanning motion which may comprise a 1515 'windshield wiper' motion.
FIG. 5b is an upper plan view illustrating the protrusions and lysing elements of an alternative embodiment of a tissue dissector and modifier, wherein some of the protrusions and lysing elements are oriented in a non-axial direction and some of the non-axial protrusions extend beyond the width of the distal shaft. In the depicted embodiment 501 b represents the tip
1520 area which lies adjacent to shaft area 502b which is connected to handle area 503b; 504b
represents an axially aligned protrusion; 551 b represents a non-axially aligned protrusion; 552b represents a non-axially aligned relative recession; 507b represents a first energy window; 508b represents a second energy window; 510b and 514b represent sensor elements; 515b
represents an electromagnetic radiation delivery element.
1525 FIG. 5b is an upper plan view illustrating the protrusions and lysing elements of an
alternative embodiment of a tissue dissector and modifier, wherein some of the protrusions and lysing elements are oriented in a non-axial direction and some of the non-axial protrusions extend beyond the width of the distal shaft. In the depicted embodiment 501 b represents the tip area which lies adjacent to shaft area 502b which is connected to handle area 503b; 504b
1530 represents an axially aligned protrusion; 551 b represents a non-axially aligned protrusion; 552b represents a non-axially aligned relative recession; 507b represents a first energy window; 508b represents a second energy window; 510b and 514b represent sensor elements similar to those previously discussed in other embodiments; 515b represents an electromagnetic radiation delivery element similar to those previously discussed in other embodiments.
1535 FIG. 5c is a lower plan view of the embodiment of FIG. 5a illustrating the protrusions and lysing elements of a tissue dissector and modifier, wherein some of the protrusions and lysing elements are oriented in a non-axial direction and the non-axial protrusions do not extend beyond the width of the distal shaft. In the depicted embodiment 501 a represents the tip area which lies adjacent to shaft area 502a which is connected to handle area 503a; 516a represents
1540 a fluid port; 517a represents a suction and/or vacuum port; 518a represents an antenna, such as an RFID TAG. In embodiments in which antenna 518a comprises an RFID tag, the RFID tag may comprise a RFID transponder. In other embodiments the RFID tag may comprise a passive tag. It should be understood that although antenna 518a is not depicted in every one of the other figures, any of the embodiments described herein may include one or more such
1545 locations. Other embodiments may comprise one or more antennas on any other suitable
location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft. In some embodiments an RFID transponder or other antenna may comprise a microchip such as a microchip having a rewritable memory. In an embodiment the tag is millimeter sized. In some embodiments a reader generates an alternating electromagnetic field
1550 which activates the antenna/RFID transponder and data is sent via frequency modulation. In an embodiment, the position of the antenna/RFID tag is determined by an alternating
electromagnetic field in the ultra-high frequency range. The position may be related to a 3 dimensional mapping of the subject. In an embodiment the reader may generate an alternating electromagnetic field. In a further embodiment the alternating electromagnetic field may be in 1555 the shortwave (13.56MHz) or UHF (865-869MHz) frequency.
In some embodiments, a suction/vacuum port 517a may be provided on or about the tip or distal shaft. The port may be fluidly coupled with a vacuum; the vacuum may comprise a pump or a negative pressure chamber or a syringe at the end of a fluid conduit. Other embodiments may comprise one or more suction/vacuum ports on any other suitable location on the TDM,
1560 including but not limited to on the protrusions or otherwise on the tip, and on the shaft. In some embodiments, a fluid delivery port 516a may be provided. In some embodiments the fluid delivery port may be coupled with a pump or high pressure fluid. In some embodiments the port may be perpetually open such that fluid may be delivered therethrough upon actuation of a pump or fluid pressure system. In other embodiments the port may be closed and selectively
1565 opened to deliver fluid therethrough. Other embodiments may comprise one or more fluid ports on any other suitable location on the TDM, including but not limited to on the protrusions or otherwise on the tip, and on the shaft. Fluid ports that may be useful include channels within the TDM, polymer lines, etc. Fluids that may emanate from the port may include ionic fluids such as saline, medicines (including but not limited to antibiotics, anesthetics, antineoplastic
1570 agents, bacteriostatic agents, etc.), non-ionic fluids, and or gasses (including but not limited to nitrogen, argon, air, etc.). In some embodiments fluids and or gasses may be under pressure or sprayed. It should be understood that although elements 516a and/or 517a are not depicted in every one of the other figures, any of the embodiments described herein may include one or more such elements.
1575 In some embodiments tip 501a may be attached to a robotic arm. In some embodiments tip
501a and portion of shaft 502a may be attached to a robotic arm. In some embodiments tip 501a and a portion of shaft 502a and or a portion of handle 503a may be attached to a robotic arm.
FIG. 5d is a lower plan view of the embodiment of FIG. 5b illustrating the protrusions and 1580 lysing elements of a tissue dissector and modifier, wherein some of the protrusions and lysing elements are oriented in one or more non-axial directions and at least some of the non-axial protrusions extend beyond the width of the distal shaft. In the depicted embodiment tip area 501 b represents the tip area which lies adjacent to shaft area 502b which is connected to handle area 503b; this particular embodiment also comprises fluid port 516b; suction port 517b; 1585 518b represents an antenna, such as an RFID TAG. In embodiments in which the antenna comprises an RFID tag, the RFID tag may comprise a RFID transponder. In other embodiments the RFID tag may comprise a passive tag. It should be understood that although antenna 518b is not depicted in every one of the other figures, any of the embodiments described herein may include one or more such locations.
1590 The tips depicted in Figures 5a,b,c,d are contemplated to be able to be used with any of the embodiments discussed herein. Said tips are not intended to be restricted to symmetry and/or pattern and/or dimension. In other embodiments said tips may be asymmetrical or lacking protrusions and/or lysing elements on one side or another.
In some embodiments the tissue dissector and modifier may have an asymmetrical tip area.
1595 More particularly some embodiments may comprise a plurality of non-axial protrusions along the left or right side of the tip. For example, the right side of the tip may lack any protrusions and thus also lacks recessions. Instead, the right side of the tip may comprise an at least substantially flat surface area.
In some embodiments, the surgical system may comprise a plurality of modular tips that
1600 may further comprise a first plurality of protrusions and/or a second plurality of protrusions, wherein the first plurality of protrusions is positioned to at least substantially extend in a first direction when the modular tip is coupled with the shaft, and wherein the second plurality of protrusions is positioned to at least substantially extend in a second direction distinct from the first direction when the modular tip is coupled with the shaft. Some embodiments may comprise
1605 a tip further comprising a first plurality of protrusions and a second plurality of protrusions,
wherein the first plurality of protrusions is positioned to at least substantially extend in a first direction, and wherein the second plurality of protrusions is positioned to at least substantially extend in a second direction distinct from the first direction and/or at least one lysing element positioned between at least two adjacent protrusions in the first plurality of protrusions and/or at
1610 least one lysing element positioned between at least two adjacent protrusions in the second plurality of protrusions. In some embodiments the first direction may be at least substantially perpendicular to the second direction. In other embodiments, the first direction may extend at an acute angle relative to the second direction. In some embodiments, at least one lysing element may comprise at least one lysing segment.
1615 Said modular TD and/or TDM are not intended to be restricted to symmetry and/or pattern and/or dimension. In other embodiments said modular TD and/or TDM may be asymmetrical or lacking protrusions and/or lysing elements on one side or another.
FIG. 6 depicts an embodiment of a modular TD 600 comprising a tip 601 , a electrosurgical 'pencil' shaft 602, and an electrosurgical 'pencil' handle 603. Rocker switch 603.2 located on or
1620 about handle 603 and/or shaft 602 may control the electrosurgical energy/energies derived from an electrosurgical generator (not seen in this view) brought into the handle via conduit 61 1.2. Tip 601 is modular in that it is removable from shaft 602. More particularly, tip 601 comprises a means for removably coupling the tip with a shaft at 668. In the depicted embodiment, this coupling means comprises a tip plug 668. In some embodiments, tip plug 668 may be threaded
1625 to facilitate a secure coupling between modular tip 601 and shaft 602. However, in other
embodiments, the coupling means may comprise a recess configured to receive a plug formed on the shaft. In still other embodiments, the coupling means may comprise a snap-fit coupling, a friction fit coupling, a bayonet clip, etc. In the depicted embodiment, tip plug 668 is configured to be received within a corresponding
1630 recess 669 formed within shaft 602. In some embodiments, elements within tip plug 668 and/or recess 669 may be electrically connected with electrical elements within shaft 602 and/or handle 603 which are in turn connected with switch 603.2 and/or conduit 611.2. In some
embodiments, tip plug 668 may be configured to electrically couple tip 601 with shaft 602. In this manner, in embodiments comprising, for example, lysing elements, electricity from a power
1635 source may be transmitted through the coupling between plug 668 and recess 669 to allow for energizing the lysing elements.
In some embodiments, tip 601 may be disposable as well, such that a surgeon can place an appropriate tip on the shaft and remove and dispose of the tip after surgery. Alternatively or additionally, a plurality of different tips may be provided, each of which may be disposable, or
1640 may be configured for sterilization and re-use, and an appropriate tip may be selected as
needed for a particular surgery.
In the depicted embodiment, tip 601 comprises a plurality of protrusions 604, some of which are non-axial, and a plurality of recessions 605 positioned therebetween, as described above. In some embodiments a tip comprising only axial protrusions may be swapped for tip 601 as
1645 desired to suit a particular surgical procedure.
In some embodiments, the plug connection may be made tighter by things such as putting screw threads and/or a hole for a twisted wire and/or a jacket and/or a form-fit and/or a spear prong, etc., in one or more portions of the receiving or the giving portions of the plug; such things may prevent rotation of the tip in/on certain devices.
1650 Some embodiments may comprise a removable tip for a surgical tool, which may further comprise a plurality of protrusions and/or at least one recessed region positioned between at least a subset of the adjacent protrusions and/or at least one lysing element positioned in at least one of the recessed regions and/or a means for removably coupling the tip with a shaft of a surgical tool. In an embodiment, a means for removably coupling the tip with a shaft of a
1655 surgical tool which may comprise an electrically conductive portion configured to electrically couple with a corresponding electrically conductive portion of the surgical tool. In another embodiment, the electrically conductive portion may be configured to deliver electrosurgical current from the surgical tool to the at least one lysing element. In some embodiments, the surgical tool may comprise an endoscope. In other embodiments, the at least one lysing
1660 element may comprise at least one lysing segment. In some embodiments, a surgical system may comprise a surgical tool comprising a shaft and/or a plurality of modular tips, wherein at least a subset of the plurality of modular tips is distinct from at least a subset of the other modular tips in the plurality of modular tips to provide for distinct functions for particular surgical procedures, and wherein each of the plurality of modular tips may further comprise: a plurality of
1665 protrusions and/or at least one recessed region positioned between at least a subset of the adjacent protrusions and/or a means for removably coupling the modular tip with the shaft of the surgical tool.
An embodiment of a system 700 for performing robotic surgery using a TDM is depicted in FIG. 7a. System 700 may comprise a tissue dissecting and modifying wand (TDM) 701. TDM 1670 701 may comprise a tissue dissecting and modifying wand (TDM) that may, as described
elsewhere herein, comprise a plurality of protrusions with one or more recessions positioned therebetween. TDM 701 may be coupled with one or more robotic surgery components, such as a surgical arm.
In some embodiments, TDM 701 may comprise a shaft, a tip, and/or a handle, as described 1675 elsewhere in this disclosure. In such embodiments, TDM 701 may be selectively coupled to a robotic arm such that the TDM 701 can either be used by hand, or coupled with one or more robotic surgery components to allow a surgeon to perform a surgical procedure with the TDM 701 remotely and/or indirectly. In other embodiments, the TDM may be configured to be integrally coupled with, or otherwise non-selectively coupled with, one or more robotic surgery 1680 components. In such embodiments, it may not be necessary to configure the TDM 701 with a handle and/or shaft. In other words, in some embodiments, the TDM 701 may comprise only a tip.
In some embodiments, the robotic surgery system 700 may comprise one or more motors, such as a screw-drive motor, gear motor, hydraulic motors, etc. In some embodiments, the
1685 robotic surgery system 700 may comprise worm gearheads, video cameras, motor control circuits, monitors, remote control devices, illumination sources, tactile interface, etc. In the embodiment depicted in FIG. 7a, TDM 700 comprises a TDM tip 701a that is positioned at the end of a robotic arm. This robotic arm comprises a plurality of arm segments 773 with corresponding joints 776 positioned therebetween. A primary joint 777 may be positioned to
1690 support and articulate together each of the arm segments 773 and smaller joints 776. Primary joint has a primary arm segment 774 that extends therefrom. Finer movements of the robotic arm may then be accomplished using one or more of the smaller joints 776.
A stand 781 may also be provided to support the various robotic arms. In some embodiments, stand 781 may also be configured to support a monitor 779 and/or other display,
1695 input, or control components, such as a control element 778. In some embodiments, control element 778 may comprise a hand control toggle 778. In other embodiments, control element 778 may comprise a keyboard, mouse, touchscreen display, virtual reality system, control pad, or the like. Monitor 779 and/or control element 778 may be communicatively coupled with a central processing unit 780.
1700 Central processing unit 780 may comprise, for example, one or more microprocessors
and/or other electronic components, such as data connectivity elements, memory, non- transitory computer readable media, etc. In some embodiments, central processing unit 780 may comprise a general-purpose computer. Central processing unit 780 may further comprise a machine-readable storage device, such as non-volatile memory, static RAM, dynamic RAM,
1705 ROM, CD-ROM, disk, tape, magnetic storage, optical storage, flash memory, or another
machine-readable storage medium.
FIG. 7b illustrates an alternative embodiment of a robotic arm 772 that may be used with system 700. Robotic arm 772 comprises an endoscopic snake-like robotic arm 772 and also comprises a TDM 701 b positioned at its distal end. As with the embodiment of FIG. 7a,
1710 TDM 701 b may be selectively coupled to robotic arm 772 or, alternatively, may be integrally or otherwise non-selectively coupled to robotic arm 772. Further details regarding robotic surgery components that may be useful in connection with the various embodiments disclosed herein may be found in the following U.S. Patent Nos., each of which is hereby incorporated by reference in its entirety:. 4,259,876 titled Mechanical Arm, 4,221 ,997 titled Articulated Robot
1715 Arm and Method Of Moving Same, 4,462,748 titled Industrial Robot, 4,494,417 titled Flexible Arm, Particularly a Robot Arm, 4,631 ,689 titled Multi-Joint Arm Robot Apparatus, 4,806,066 titled Robotic Arm, 5,791 ,231 titled Surgical Robotic System and Hydraulic Actuator Therefor, 7,199,545 titled Robot For Surgical Applications, 7,316,681 titled Articulated Surgical Instrument For Performing Minimally Invasive Surgery With Enhanced Dexterity and Sensitivity, 8, 182,418
1720 titled Systems and Methods for Articulating An Elongate Body, 8,224,485 titled Snaking Robotic Arm With Movable Shapers.
Any of the embodiments of TDM discussed herein including, but not limited to, the embodiments discussed with Figs 1a-g, Figs 2a-c, Figs 3a-c, Fig 4, Figs 5a,b,c,d, etc. may be used in conjunction with one or more of the robotic surgery elements disclosed in connection
1725 with Figures 7a-b.
Some embodiments may comprise a tip further comprising a plurality of protrusions and/or at least one lysing element positioned between each of the protrusions and/or a tip positioned at a distal end of the shaft, wherein the tip comprises a plurality of protrusions and at least one lysing element positioned between at least two adjacent protrusions in the plurality of
1730 protrusions. Some embodiments may comprise a robotic arm configured to allow a surgeon to operate using the apparatus indirectly, wherein the tip is positioned at a distal end of the robotic arm. In an embodiment, a robotic surgery system may be coupled with the robotic arm. In another embodiment, the robotic surgery system may comprise a control element. In another embodiment, the control element may comprise at least one of a hand control toggle, a
1735 keyboard, a mouse, a touchscreen display, a virtual reality system, and a control pad.
FIG. 8 depicts an embodiment of a modular TD 800 comprising a tip 801 , a flexible shaft 802, and an endoscope handle 803. Tip 801 is modular in that it is removable from flexible shaft 802. More particularly, tip 801 comprises a means for removably coupling the tip with a shaft at 868. In the depicted embodiment, this coupling means comprises a tip plug 868. In 1740 some embodiments, tip plug 868 may be threaded to facilitate a secure coupling between modular tip 801 and shaft 802. However, in other embodiments, the coupling means may comprise a recess configured to receive a plug formed on the shaft. In still other embodiments, the coupling means may comprise a snap-fit coupling, a friction fit coupling, a bayonet clip, etc. In the depicted embodiment, tip plug 868 is configured to be received within a corresponding
1745 recess 869 formed within shaft 802. In some embodiments, tip plug 868 may be configured to electrically couple tip 801 with shaft 802. In this manner, in embodiments comprising, for example, lysing elements, electricity from a power source may be transmitted through the coupling between plug 868 and recess 869 to allow for energizing the lysing elements. Other embodiments may be configured to transfer additional electricity, data, or materials through
1750 such coupling. For example, in embodiments comprising one or more sensors on tip 801 , a signal from such sensor(s) may be transmitted through shaft 802 by way of the coupling means 868.
In some embodiments, tip 801 may be disposable as well, such that a surgeon can place an appropriate tip on the shaft and remove and dispose of the tip after surgery. Alternatively or 1755 additionally, a plurality of different tips may be provided, each of which may be disposable, or may be configured for sterilization and re-use, and an appropriate tip may be selected as needed for a particular surgery.
In the depicted embodiment, tip 801 comprises a plurality of protrusions 804, some of which are non-axial, and a plurality of recessions 805 positioned therebetween, as described above. 1760 In some embodiments a tip comprising only axial protrusions may be swapped for tip 801 as desired to suit a particular surgical procedure.
An example of an embodiment of an apparatus according to this disclosure for tissue dissection and modification may comprise:
a handle;
1765 a tip comprising a plurality of protrusions having one or more lysing elements positioned between the protrusions; and
an energy window positioned on an upper side of the apparatus, wherein the energy window comprises a thermochromic media, and wherein the thermochromic media is configured to absorb electromagnetic radiation energy and emit heat energy from the energy window. 1770 In some embodiments as described above, the energy window may comprise a LASER that is configured to deliver energy to the thermochromic media such that the thermochromic media can then emit heat energy from the energy window.
An example of an embodiment of an apparatus according to this disclosure for tissue dissection and modification may comprise:
1775 a handle;
a tip comprising a plurality of protrusions having one or more lysing elements positioned between the protrusions; and
an energy window positioned on an upper side of the apparatus, wherein the energy window comprises a microwave antennae, and wherein the microwave antennae is configured 1780 to convert electromagnetic energy and emit microwave energy from the energy window.
Another example of an embodiment of an apparatus according to this disclosure for tissue dissection and modification may comprise:
a handle;
a tip comprising a plurality of protrusions having one or more lysing elements positioned 1785 between the protrusions; and
an energy window positioned on an upper side of the apparatus, wherein the energy window comprises an target-tissue-impedance-matched-microwave-based energy window.
It will be understood by those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles presented 1790 herein. For example, any suitable combination of various embodiments, or the features thereof, is contemplated.
Any methods disclosed herein comprise one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the
1795 embodiment, the order and/or use of specific steps and/or actions may be modified.
Throughout this specification, any reference to "one embodiment," "an embodiment," or "the embodiment" means that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the quoted phrases, or variations thereof, as recited throughout this specification are not necessarily all referring to the
1800 same embodiment.
Similarly, it should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than those expressly
1805 recited in that claim. Rather, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment. It will be apparent to those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles set forth herein.
Furthermore, the described features, components, structures, steps, or characteristics may
1810 be combined in any suitable manner in one or more alternative embodiments and/or
implementations. In other words, any of the features, components, structures, steps, or characteristics disclosed in any one disclosed embodiment may be combined with features, components, structures, steps, or characteristics of other disclosed embodiments.

Claims

1. An apparatus for tissue separation and modification, comprising:
a tip comprising a plurality of protrusions;
at least one lysing element positioned between each of the protrusions; and a tip positioned at a distal end of the shaft, wherein the tip comprises a plurality of protrusions and at least one lysing element positioned between at least two adjacent protrusions in the plurality of protrusions; and
an energy window comprising a thermochromic media, wherein the thermochromic media is configured to absorb electromagnetic radiation energy and emit heat energy from the energy window, and wherein the energy window is positioned and configured to deliver the heat energy from the apparatus to tissue adjacent to the apparatus during an operation.
2. The apparatus of claim 1 , further comprising a LASER that is configured to deliver energy to the thermochromic media such that the thermochromic media can emit heat energy from the energy window.
3. The apparatus of claim 2, further comprising a fiber optic cable configured to deliver LASER energy to the thermochromic media.
4. The apparatus of claim 1 , wherein the thermochromic media is configured such that the temperature of the energy window cannot exceed a threshold temperature.
5. The apparatus of claim 1 , wherein the at least one lysing element comprises at least one lysing segment.
6. An apparatus for separating and modifying tissue, comprising:
a tip comprising a plurality of protrusions;
at least one lysing element positioned between each of the protrusions; and an energy window comprising a target-tissue-impedance-matched-microwave based energy window, wherein the target-tissue-impedance-matched-microwave based energy window is positioned and configured to deliver microwave energy from the apparatus to incapacitate eccrine glands within a target region of a patient's skin.
7. The apparatus of claim 6, wherein the energy window comprises an array of impedance- matched- microwave emitting antennae.
8. The apparatus of claim 6, further comprising a sensor for receiving and delivering information to a user.
9. The apparatus of claim 8, wherein the sensor comprises at least one of a thermal sensor, a photoelectric sensor, a photo-optic sensor, a camera, and a MEMS sensor.
10. The apparatus of claim 6, wherein the at least one lysing element comprises at least one lysing segment.
1 1. A removable tip for a surgical tool, comprising: a plurality of protrusions;
at least one recessed region positioned between at least a subset of the adjacent protrusions;
at least one lysing element positioned in at least one of the recessed regions; and
a means for removably coupling the tip with a shaft of a surgical tool.
12. The removable tip of claim 1 1 , wherein the means for removably coupling the tip with a shaft of a surgical tool further comprises an electrically conductive portion configured to electrically couple with a corresponding electrically conductive portion of the surgical tool.
13. The removable tip of claim 1 1 , wherein the electrically conductive portion is configured to deliver electrosurgical current from the surgical tool to the at least one lysing element.
14. The removable tip of claim 1 1 , wherein the surgical tool comprises an endoscope.
15. The tip of claim 1 1 , wherein the at least one lysing element comprises at least one lysing segment.
16. A surgical system, comprising:
a surgical tool comprising a shaft; and
a plurality of modular tips, wherein at least a subset of the plurality of modular tips is distinct from at least a subset of the other modular tips in the plurality of modular tips to provide for distinct functions for particular surgical procedures, and wherein each of the plurality of modular tips comprises:
a plurality of protrusions;
at least one recessed region positioned between at least a subset of the adjacent protrusions; and
a means for removably coupling the modular tip with the shaft of the surgical tool.
17. The surgical system of claim 16, wherein at least a subset of the plurality of modular tips comprises:
a first plurality of protrusions; and
a second plurality of protrusions, wherein the first plurality of protrusions is positioned to at least substantially extend in a first direction when the modular tip is coupled with the shaft, and wherein the second plurality of protrusions is positioned to at least substantially extend in a second direction distinct from the first direction when the modular tip is coupled with the shaft.
18. An apparatus for tissue separation and modification, comprising:
a tip comprising a first plurality of protrusions and a second plurality of protrusions, wherein the first plurality of protrusions is positioned to at least substantially extend in a first direction, and wherein the second plurality of protrusions is positioned to at least substantially extend in a second direction distinct from the first direction; at least one lysing element positioned between at least two adjacent protrusions in the first plurality of protrusions; and
at least one lysing element positioned between at least two adjacent protrusions in the second plurality of protrusions.
19. The apparatus of claim 18, wherein the first direction is at least substantially perpendicular to the second direction.
20. The apparatus of claim 18, wherein the first direction extends at an acute angle relative to the second direction.
21. The apparatus of claim 18, wherein the at least one lysing element comprises at least one lysing segment.
22. An apparatus for tissue separation, comprising:
a tip comprising a plurality of protrusions;
at least one lysing element positioned between each of the protrusions; and a tip positioned at a distal end of the shaft, wherein the tip comprises a plurality of protrusions and at least one lysing element positioned between at least two adjacent protrusions in the plurality of protrusions.
23. The apparatus of claim 22, further comprising a robotic arm configured to allow a surgeon to operate using the apparatus indirectly, wherein the tip is positioned at a distal end of the robotic arm.
24. The apparatus of claim 23, further comprising a robotic surgery system coupled with the robotic arm.
25. The apparatus of claim 24, wherein the robotic surgery system comprises a control element.
26. The apparatus of claim 25, wherein the control element comprises at least one of a hand control toggle, a keyboard, a mouse, a touchscreen display, a virtual reality system, and a control pad.
27. The apparatus of claim 22, further comprising a feedback means for providing information to a user to avoid excess energy delivery to tissue.
28. The apparatus of claim 27, wherein the feedback means is configured to notify a user when a temperature of tissue adjacent to the apparatus has reached a predetermined threshold temperature.
29. The apparatus of claim 22, wherein the feedback means comprises an antenna.
30. The apparatus of claim 29, wherein the antenna comprises a radiofrequency identification tag.
31. The apparatus of claim 30, wherein the radiofrequency identification tag comprises a passive tag.
32. The apparatus of claim 30, wherein the radiofrequency identification tag is configured to allow for determining the position of the tag relative to a patient using an alternating electromagnetic field.
33. The apparatus of claim 32, further comprising a temperature sensor configured to sense a temperature of tissue positioned adjacent to the apparatus during an operation.
34. The apparatus of claim 33, further comprising a display unit configured to display information to a user during an operation.
35. The apparatus of claim 34, wherein the display unit is configured to display visual information comprising information from the temperature sensor and the radiofrequency identification tag such that a user can visualize one or more regions within a patient's body that have been sufficiently treated.
36. The apparatus of claim 35, wherein the visual information comprises an indication of the one or more regions that have reached a predetermined threshold temperature.
37. The apparatus of claim 32, wherein the alternating electromagnetic field is one of a shortwave and UHF frequency.
38. The apparatus of claim 22, wherein the at least one lysing element comprises at least one lysing segment.
39. A surgical tool comprising:
a plurality of protrusions;
at least one lysing element positioned between at least two adjacent protrusions among the plurality of protrusions;
an antenna positioned on the tissue dissecting and modifying wand and configured to provide location data regarding a location of the tissue dissecting and modifying wand during a procedure; and
receiving data from the tissue dissecting and modifying wand generated from the antenna, wherein the data allows a user to determine one or more regions within a patient's body that have been treated.
40. The apparatus of claim 39, wherein the at least one lysing element comprises at least one lysing segment.
41. The apparatus of claim 22 further comprising a lysing element configured to emit electromagnetic energy.
42. The apparatus of claim 41 , wherein said electromagnetic energy comprises bipolar radiofrequency electrosurgical current.
PCT/IB2013/059532 2012-10-24 2013-10-22 Apparatus & systems for tissue dissection & modification WO2014064607A1 (en)

Applications Claiming Priority (10)

Application Number Priority Date Filing Date Title
US13/659,873 2012-10-24
US13/659,873 US20130338652A1 (en) 2012-06-13 2012-10-24 Minimally invasive eccrine gland incapacitation apparatus and methods
US13/759,969 2013-02-05
US13/759,969 US20140188128A1 (en) 2012-12-31 2013-02-05 Systems, apparatus and methods for tissue dissection and modification
US13/802,731 US20140188095A1 (en) 2012-12-31 2013-03-14 Apparatus and systems for tissue dissection and modification
US13/802,731 2013-03-14
US201361840406P 2013-06-27 2013-06-27
US61/840,406 2013-06-27
NZ61686213 2013-10-18
NZ616862 2013-10-18

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