US20150245849A1 - Mechanism for Assembly of Ultrasonic Instrument - Google Patents
Mechanism for Assembly of Ultrasonic Instrument Download PDFInfo
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- US20150245849A1 US20150245849A1 US14/699,592 US201514699592A US2015245849A1 US 20150245849 A1 US20150245849 A1 US 20150245849A1 US 201514699592 A US201514699592 A US 201514699592A US 2015245849 A1 US2015245849 A1 US 2015245849A1
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- torque
- blade
- ultrasonic
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- tissue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B25—HAND TOOLS; PORTABLE POWER-DRIVEN TOOLS; MANIPULATORS
- B25B—TOOLS OR BENCH DEVICES NOT OTHERWISE PROVIDED FOR, FOR FASTENING, CONNECTING, DISENGAGING OR HOLDING
- B25B23/00—Details of, or accessories for, spanners, wrenches, screwdrivers
- B25B23/14—Arrangement of torque limiters or torque indicators in wrenches or screwdrivers
- B25B23/142—Arrangement of torque limiters or torque indicators in wrenches or screwdrivers specially adapted for hand operated wrenches or screwdrivers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
- A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
-
- G—PHYSICS
- G10—MUSICAL INSTRUMENTS; ACOUSTICS
- G10K—SOUND-PRODUCING DEVICES; METHODS OR DEVICES FOR PROTECTING AGAINST, OR FOR DAMPING, NOISE OR OTHER ACOUSTIC WAVES IN GENERAL; ACOUSTICS NOT OTHERWISE PROVIDED FOR
- G10K11/00—Methods or devices for transmitting, conducting or directing sound in general; Methods or devices for protecting against, or for damping, noise or other acoustic waves in general
- G10K11/18—Methods or devices for transmitting, conducting or directing sound
- G10K11/24—Methods or devices for transmitting, conducting or directing sound for conducting sound through solid bodies, e.g. wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/28—Surgical forceps
- A61B17/2812—Surgical forceps with a single pivotal connection
- A61B17/282—Jaws
- A61B2017/2825—Inserts of different material in jaws
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
- A61B2017/320071—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with articulating means for working tip
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
- A61B2017/320089—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic node location
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
- A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
- A61B2017/320093—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw additional movable means performing cutting operation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
- A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
- A61B2017/320094—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw additional movable means performing clamping operation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
- A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
- A61B2017/320095—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw with sealing or cauterizing means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, 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
- A61B90/03—Automatic limiting or abutting means, e.g. for safety
- A61B2090/031—Automatic limiting or abutting means, e.g. for safety torque limiting
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, 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
- A61B90/03—Automatic limiting or abutting means, e.g. for safety
- A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
Abstract
Description
- The present application claims the priority benefit of U.S. provisional patent application Ser. No. 60/809,971, filed on Jun. 1, 2006.
- The present invention relates, in general, to ultrasonic surgical instruments and, more particularly, to an ultrasonic surgical clamp coagulator apparatus particularly configured to provide increased tissue transection forces.
- This application contains subject matter that relates to and incorporates by reference in their entirety, for any and all purposes, the following non-provisional applications:
- ULTRASONIC SURGICAL BLADE AND INSTRUMENT HAVING A GAIN STEP, U.S. Pat. No. 7,163,548.
- TISSUE PAD FOR USE WITH AN ULTRASONIC SURGICAL INSTRUMENT, Ser. No. 11/245,819, filed Oct. 7, 2005;
- COMBINATION TISSUE PAD FOR USE WITH AN ULTRASONIC SURGICAL INSTRUMENT, Ser. No. 11/246,794, filed Oct. 7, 2005;
- ACTUATION MECHANISM FOR USE WITH AN ULTRASONIC SURGICAL INSTRUMENT, Ser. No. 11/246,826, filed Oct. 7, 2005;
- CLAMP MECHANISM FOR USE WITH AN ULTRASONIC SURGICAL INSTRUMENT, Ser. No. 11/246,264, filed Oct. 7, 2005;
- FEEDBACK MECHANISM FOR USE WITH AN ULTRASONIC SURGICAL INSTRUMENT, Ser. No. 11/246,384, filed Oct. 7, 2005;
- HANDLE ASSEMBLY HAVING HAND ACTIVATION FOR USE WITH AN ULTRASONIC SURGICAL INSTRUMENT, Ser. No. 11/246,330, filed Oct. 7, 2005;
- ULTRASONIC SURGICAL SHEARS AND TISSUE PAD FOR SAME, Ser. No. 11/065,378, filed Feb. 24, 2005; and
- HAND ACTIVATED ULTRASONIC INSTRUMENT, Ser. No. 10/869,351, filed Jun. 16, 2004.
- Further, this application shares a common specification with the following U.S. patent applications filed contemporaneously herewith: ULTRASONIC WAVEGUIDE AND BLADE, serial no. [Atty. Docket no. END5881USNP1]; ULTRASONIC BLADE SUPPORT, serial no. [Atty. Docket no. END5881USNP2]; and MECHANISM FOR ASSEMBLY OF ULTRASONIC INSTRUMENT, serial no. [Atty. Docket no. END5881USNP3 ].
- Ultrasonic surgical instruments are finding increasingly widespread applications in surgical procedures by virtue of the unique performance characteristics of such instruments. Depending upon specific instrument configurations and operational parameters, ultrasonic surgical instruments can provide substantially simultaneous cutting of tissue and hemostasis by coagulation, desirably minimizing patient trauma. The cutting action is typically effected by an end-effector or blade tip at the distal end of the instrument, which transmits ultrasonic energy to tissue brought into contact with the end-effector. Ultrasonic instruments of this nature can be configured for open surgical use, laparoscopic or endoscopic surgical procedures including robotic-assisted procedures.
- Ultrasonic surgical instruments have been developed that include a clamp mechanism to press tissue against the blade of the end-effector in order to couple ultrasonic energy to the tissue of a patient. Such an arrangement (sometimes referred to as a clamp coagulator shears or an ultrasonic transector) is disclosed in U.S. Pat. Nos. 5,322,055; 5,873,873and 6,325,811, all of which are incorporated herein by reference. The surgeon activates the clamp arm to press the clamp pad against the blade by squeezing on the handgrip or handle.
- Some current ultrasonic shears devices, however, have the tendency to create tissue tags. Tissue tags are the tissue that remains clamped in the jaw that is not transected after the majority of the tissue in the jaw has been transected and falls away. Tissue tags may result from insufficient end-effector or blade tip proximal loading and/or lower proximal blade activity. Surgeons may mitigate tissue tags either through the addition of vertical tension (i.e. putting tension on the tissue using the blade) or rearward traction on the device in order to move the untransected tissue to a more active portion of the blade to complete the cut.
- Some current ultrasonic shears devices utilize tissue pads that close in parallel with the surface of the blade. This presents certain problems in terms of the pressure profile exerted on the tissue. As tissue is compressed between the jaw and the blade, the distal portion of the blade deflects under load more than the proximal portion of the blade. This deflection is created in part by the portion of the blade distal to the most distal node of the device. It is also partly created by the deflection of the waveguide or transmission rod proximal to the most distal node. Additionally, the fact that blade amplitude decreases moving proximal of the tip of the blade makes the situation worse since the amount of energy transferred to the tissue, even if the pressure was constant, is reduced.
- Current tissue pad designs utilize PTFE material to contact the tissue and blade. Although these designs have been adequate, they tend to suffer from longevity issues since the pads tend to deteriorate over long surgical procedures. Additionally, newer designs of clamp coagulator shears increase blade amplitude and/or the loading of the pad against the tissue and blade and overwhelm the pad material, resulting in less than required tissue pad life. The pad material limits the amount of force that may be applied against the tissue and blade, which in turn limits the tissue thickness or vessel size that some current clamp coagulator shears may effectively cut and coagulate. Current composite pads may be difficult or expensive to manufacture.
- Some current designs of clamp coagulator ultrasonic shears are limited in the length of the active blade available for use by surgeons due to inherent limitations in the effective transfer of mechanical motion along the longitudinal path of the blade from the transducer assembly. Although new blade geometry has mitigated some of these problems, longer active blade lengths, or blades that have more mass (created by larger diameter or larger lengths) have a tendency to shrink the frequency window between resonant and anti-resonant frequencies making it difficult or impossible for ultrasonic generators to lock on to the proper frequency to drive the waveguide, blade and transducer assembly.
- Some current designs of clamp coagulator shears utilize elastomer material such as silicone for node supports along the length of the blade. The most distal node support is typically silicone to provide for a seal around the blade. Where higher clamp forces are desired, as is the case with longer active blade lengths, it is desirable to have a rigid distal node support. Many problems, however, are inherent with rigid node supports. Materials such as thermoset polymers that are capable of withstanding the pressure and temperature requirements of an ultrasonic blade node support are often too expensive to be utilized in production. The use of thermoplastics would improve manufacturability from a cost perspective but may not hold up to the pressure and temperature requirements of an ultrasonic blade node support.
- Some current designs of clamp coagulator shears utilize a constant force spring mechanism that prevents the application of too much force to the clamp arm and blade. Although the mechanism provides relatively constant force to the system, the spring imparts some slope to the force curve. In applications where the clamp force is low, the slope is not significant. In applications with high clamp forces, however, the difference in force attributable to the slope over the possible range of spring compressions becomes very significant and may exceed the maximum force allowable in the blade, in the tube assemblies or in other components of the system. The high slope could allow the maximum force to be exceeded under abuse modes or through normal manufacturing tolerance variations. If this occurs, the blade may bend, the actuation mechanism may fail or undesirable tissue effects may occur (i.e. fast cutting, but minimal tissue coagulation). This situation is aggravated by the fact that a portion of the jaw (the clamp arm and pad) of the device can meet sufficient resistance to engage the force limiting mechanism when the clamp pad almost contacts the blade (when transecting thin tissue or at the end of the transection or clamping solid objects such as other devices) or when the clamp arm is still open with respect to the blade (when transecting thick tissue).
- Some current designs of clamp coagulator shears utilize force-limiting springs to ensure that clamp forces are within a specified range. It is also necessary for the force-limiting spring design to allow the surgeon to “feather” (apply less than the maximum force and slowly increase to the maximum force). In these mechanisms, therefore, the jaw closes until a predetermined force is met and then the additional stroke drives the mechanism into the force limiting range. In some cases, though, the surgeon may, unknowingly, fail to apply the full force of the jaw against the tissue resulting in incomplete tissue cuts or insufficient coagulation. Alternatively, the surgeon may unknowingly open the clamp arm during a transection that results in incomplete tissue cuts or insufficient coagulation.
- Some current designs of clamp coagulator shears utilize a foot pedal to energize the surgical instrument. The surgeon operates the foot pedal while simultaneously applying pressure to the handle to press tissue between the jaw and blade to activate a generator that provides energy that is transmitted to the cutting blade for cutting and coagulating tissue. Key drawbacks with this type of instrument activation include the loss of surgeon focus on the surgical field while the surgeon searches for the foot pedal, the foot pedal gets in the way of the surgeon's movement during a procedure and surgeon leg fatigue during long cases.
- Some current designs of torque wrenches for ultrasonic surgical instruments utilize a multi-piece torque wrench for use in properly torqueing an instrument to an ultrasonic handpiece. A multi-piece assembly is more costly in that separate pieces have to be molded and then assembled. In addition, the pieces have a tendency to wear rapidly leading to failure of the wrench.
- It would be desirable to provide an ultrasonic surgical instrument that overcomes some of the deficiencies of current instruments. The ultrasonic surgical instrument described herein overcomes those deficiencies.
- The present invention meets the above stated needs for an improved tissue pad for an ultrasonic surgical instrument. The tissue pad for use in an ultrasonic clamp coagulator comprises i) a first tissue pad portion, the first tissue pad portion having a distal end a proximal end, a tissue engaging surface and a cavity having an opening coinciding with the tissue engaging surface, and ii) a second tissue pad portion, the second tissue pad portion made from a composition having a greater resistance to heat than the first tissue pad portion, the second tissue pad portion having a tissue engaging surface and sized for placement within the cavity.
- A method of mounting the first tissue pad portion onto a clamp arm of an ultrasonic clamp coagulator, comprises the steps of: i) inserting the first tissue pad portion into the clamp arm, the first tissue pad portion being oriented during the insertion so that the cavity is positioned at the proximal portion of the arm, and ii). inserting into the cavity a second tissue pad portion made from a composition having a greater resistance to heat than the first tissue pad portion, the second tissue pad portion having a tissue engaging surface and sized for placement within the cavity.
- The novel features of the invention are set forth with particularity in the appended claims. The invention itself, however, both as to organization and methods of operation, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings in which:
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FIG. 1 is a plan view illustrating an embodiment of an ultrasonic surgical instrument in accordance with the present; -
FIG. 2 is a perspective assembly view of an embodiment of an ultrasonic surgical instrument in accordance with the present invention; -
FIG. 3 is a plan view of one embodiment of the waveguide and blade assembly in accordance with the present invention; -
FIG. 3 a is a sectional view of one embodiment of the distal end of the blade assembly in accordance with the present invention; -
FIG. 3 b is a plan view of one embodiment of the waveguide and blade assembly and silicone support rings in accordance with the present invention; -
FIG. 3 c is a graph depicting waveform along the length of the waveguide and blade of one embodiment of the present invention; -
FIG. 3 d is a perspective, side view and cross sectional view of one embodiment of a distal blade node support; -
FIG. 4 a depicts plan, top and cross sectional views of outer sheath and clamp arm assembly of one embodiment of the present invention; -
FIG. 4 b is a perspective assembly view of one embodiment of a clamp arm and clamp pad assembly of the present invention; -
FIG. 4 c is a plan and cross sectional view of one embodiment of a clamp arm of the present invention; -
FIG. 4 d is a perspective elevation view of one embodiment of a tissue pad insert of the present invention; -
FIG. 5 is a plan view and side view of one embodiment of the outer tube of the present invention; -
FIG. 6 is a side view and plan view of one embodiment of the inner tube of the present invention; -
FIG. 7 is a perspective assembly view of the distal end of a handpiece assembly and electrical ring contactors; -
FIG. 8 a is a perspective view of the front and rear sides of a connector and flexboard assembly of one embodiment of the present invention; -
FIG. 8 b is a plan view of the rocker switch of one embodiment of the present invention; -
FIG. 8 c is an electrical schematic of the switch circuit; -
FIG. 9 is a plan view of an ultrasonic surgical instrument in accordance with the present invention with the a first finger accessing a first activation button gripped by a left-handed surgeon; -
FIG. 10 is a plan view of an ultrasonic surgical instrument in accordance with the present invention with the a first finger accessing a first activation button gripped by a right-handed surgeon; -
FIG. 11 is a perspective, side view and cross sectional end view of one embodiment of a torque wrench; -
FIG. 12 is a perspective and cross sectional end view of one embodiment of an outer tube retainer of the present invention; and -
FIG. 13 is a force curve illustrating various forces as a function of the trigger position. - Before explaining the present invention in detail, it should be noted that the invention is not limited in its application or use to the details of construction and arrangement of parts illustrated in the accompanying drawings and description. The illustrative embodiments of the invention may be implemented or incorporated in other embodiments, variations and modifications, and may be practiced or carried out in various ways. Further, unless otherwise indicated, the terms and expressions employed herein have been chosen for the purpose of describing the illustrative embodiments of the present invention for the convenience of the reader and are not for the purpose of limiting the invention.
- Further, it is understood that any one or more of the following-described embodiments, expressions of embodiments, examples, etc. can be combined with any one or more of the other following-described embodiments, expressions of embodiments, examples, etc.
- The present invention is particularly directed to an improved ultrasonic surgical clamp coagulator apparatus which is configured for effecting tissue cutting, coagulation, and/or clamping during surgical procedures. The present apparatus can be readily configured for use in open surgical procedures, as well as laparoscopic or endoscopic procedures and robot-assisted surgical procedures. Versatile use is facilitated by selective use of ultrasonic energy. When ultrasonic components of the apparatus are inactive, tissue can be readily gripped and manipulated, as desired, without tissue cutting or damage. When the ultrasonic components are activated, the apparatus permits tissue to be gripped for coupling with the ultrasonic energy to effect tissue coagulation, with application of increased pressure efficiently effecting tissue cutting and coagulation. If desired, ultrasonic energy can be applied to tissue without use of the clamping mechanism of the apparatus by appropriate manipulation of the ultrasonic blade.
- As will become apparent from the following description, the present clamp coagulator apparatus is particularly configured for disposable use by virtue of its straightforward construction. As such, it is contemplated that the apparatus be used in association with an ultrasonic generator unit and transducer of a surgical system, whereby ultrasonic energy from the generator unit provides the desired ultrasonic actuation through the transducer for the present clamp coagulator apparatus. It will be appreciated that a clamp coagulator apparatus embodying the principles of the present invention can be configured for non-disposable or multiple uses, and non-detachably integrated with an associated hand piece (or transducer) unit. However, detachable connection of the present clamp coagulator apparatus with an associated ultrasonic hand piece is presently preferred for single-patient use of the apparatus.
- The present invention will be described in combination with an ultrasonic instrument as described herein. Such description is exemplary only, and is not intended to limit the scope and applications of the invention. For example, the invention is useful in combination with a multitude of ultrasonic instruments including those described in, for example, U.S. Pat. Nos. 5,938,633; 5,935,144; 5,944,737; 5,322,055, 5,630,420; and 5,449,370.
- With reference to
FIGS. 1-3 , an embodiment of asurgical system 19, including an ultrasonicsurgical instrument 100 in accordance with the present invention is illustrated. Thesurgical system 19 includes anultrasonic generator 30 connected to anultrasonic transducer 50 viacable 22, and an ultrasonicsurgical instrument 100. It will be noted that, in some applications, theultrasonic transducer 50 is referred to as a “hand piece assembly,” or simply “hand piece,” because the surgical instrument of thesurgical system 19 is configured such that a surgeon may grasp and manipulate theultrasonic transducer 50 during various procedures and operations. A suitable generator is theGEN 300™ sold by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio. - The ultrasonic
surgical instrument 100 includes amulti-piece handle 70 adapted to isolate the operator from the vibrations of the acoustic assembly contained withintransducer 50. Thehandle 70 can be shaped to be held by a user in a conventional manner, but it is contemplated that the present ultrasonicsurgical instrument 100 principally be grasped and manipulated by a scissor-like arrangement provided by a handle assembly of the instrument, as will be described. While single-piece handle 70 is illustrated, thehandle 70 may comprise a single or unitary component. The proximal end of the ultrasonicsurgical instrument 100 receives and is fitted to the distal end of theultrasonic transducer 50 by insertion of the transducer into thehandle 70. The ultrasonicsurgical instrument 100 may be attached to and removed from theultrasonic transducer 50 as a unit. - Referring specifically now to
FIG. 2 , the ultrasonicsurgical instrument 100 may include a handle assembly70, comprisingmating housing portions handle 70 and atransmission assembly 71. The ultrasonicsurgical instrument 100 has application in both open and endoscopic surgical procedures. The construction can be dimensioned such thattransmission assembly 71 has an outside diameter of approximately 8.5 mm. Theelongated transmission assembly 71 of the ultrasonicsurgical instrument 100 extends orthogonally from theinstrument handle 70. Thehandle 70 may be constructed from a durable plastic, such as polycarbonate or a liquid crystal polymer. It is also contemplated that thehandle 70 may alternatively be made from a variety of materials including other plastics, ceramics or metals. - The
transmission assembly 71 may include an outer tubular member orouter sheath 72, an inner tubular actuatingmember 76, awaveguide 80 and end-effector 81 (blade 79,clamp arm 56,pin 56 b and one or more clamp pads 58). As will be described, theouter sheath 72, the actuatingmember 76, and the waveguide ortransmission rod 80 may be joined together for rotation as a unit (together with ultrasonic transducer 50) relative to handle 70. Thewaveguide 80, which is adapted to transmit ultrasonic energy fromtransducer 50 toblade 79 may be flexible, semi-flexible or rigid. - The
ultrasonic waveguide 80 may further include at least one radial hole oraperture 66 extending there through, substantially perpendicular to the longitudinal axis of thewaveguide 80. Theaperture 66, which may be positioned at a node, is configured to receive aninsulated connector pin 27, which connects thewaveguide 80, to thetubular actuating member 76, and the tubularouter sheath 72, as well theouter tube retainer 29. A rotation knob 28 (not shown) may be added to or may replaceretainer 29 to facilitate rotation of theblade assembly 80, including theend effector 81 relative to instrument handle 70, as is known and understood in the art. - The
blade 79 may be integral with thewaveguide 80 and formed as a single unit. In an alternate expression of the current embodiment, a threaded connection, a welded joint, or other coupling mechanisms may connectblade 79 towaveguide 80. The distal end of theblade 79 is disposed near an anti-node in order to tune the acoustic assembly to a preferred resonant frequency fo when the acoustic assembly is not loaded by tissue. Whenultrasonic transducer 50 is energized, the distal end ofblade 79 is configured to move longitudinally in the range of, for example, approximately 10 to 500 microns peak-to-peak, and preferably in the range of about 20 to about 200 microns at a predetermined vibrational frequency fo of, for example, 55,500 Hz. - Referring now to
FIG. 3 , thewaveguide 80 may also be configured to amplify the mechanical vibrations transmitted through thewaveguide 80 to theblade 79 as is well known in the art and more fully described in ULTRASONIC SURGICAL BLADE AND INSTRUMENT HAVING A GAIN STEP, Ser. No. 10/701,558, filed Nov. 5, 2003, now U.S. Pat., No. 7,163,548B2, which is incorporated herein by reference. In one embodiment of the present invention, thewaveguide 80 may further have features to control the gain of the longitudinal vibration along thewaveguide 80 and features to tune thewaveguide 80 to the resonant frequency of the system. In particular,waveguide 80 may have any suitable cross-sectional dimension. For example, thewaveguide 80 may have a substantially uniform cross-section or thewaveguide 80 may be tapered at various sections or may be tapered along its entire length as is described in more detail herein. - In one embodiment of the present invention, the
waveguide 80 includes ahollow bore 101 located between the most distal vibration node and the distal tip of theblade 79 a. Thishollow bore 101 in the instant embodiment, facilitates longer active blade length by stretching or expanding wavelength as is known and understood in the art. This longer active blade length may requirelarger diameter blades 79 to facilitate the bore. To ensure proper performance of theblade 79 and to achieve desired cutting and coagulation action of the blade, a larger wave amplitude may be used. Increasing active blade length and wave amplitude may create difficulties for the system to achieve resonance. For instance, a system tuned to resonate at 55,500 Hz, with the hollow bore blade, may achieve anti-resonance at 55,550 Hz. This narrow frequency window may make it difficult or impossible for the generator 30 (seeFIG. 1 ) to continuously drive thewaveguide 80 andblade 79 system at its resonant frequency. - To enable larger wave amplitude and longer active blade lengths and still provide sufficient frequency margin or window, a
waveguide 80 is provided with a series of gain steps in thewaveguide 80. The gain of a gain step less than unity results from an increase in mass of the ultrasonic waveguide at a node, and the gain of a gain step greater than unity results from a decrease in mass of the waveguide at a node. A gain feature is any one of geometric constructions of the waveguide or blade that either increases or decreases the mass of the waveguide or blade at a node and include: a discrete change in outer diameter or perimeter, a taper, a longitudinal hole, a transverse hole, a void, a surface flat, a surface slot, and a change in material. The term hole includes a through hole and a non-through hole. Other gain features are left to the artisan. - In one embodiment of the present invention, a
gain step 102, located at the second most distal vibration node (seeFIG. 3 ), is provided in thewaveguide 80.Gain step 102 decreases the cross sectional area of the blade facilitating greater wave amplitude in the decreased diameter (seeFIG. 3 c), as is known and understood in the art. To facilitate the longer active blade length and to maintain a desired blade diameter, a step up 103 is provided at or near an antinode, which increases the cross sectional area ofwaveguide 80 without affecting the gain. In one embodiment, the step up 103 is located at the second most distal vibration antinode in relation to thedistal blade tip 79 a. A second step down or gainstep 104 is provided adjacent to theblade 79. Thesecond gain step 104 results in a second amplitude increase. In one embodiment, thesecond gain step 104 is located at the first most distal vibration node in relation to theblade tip 79 a. - As is known and understood in the art, in an ultrasonic blade system, a generator produces a current to drive a transducer located within
handpiece 50. This transducer imparts mechanical energy at a specific frequency to a waveguide and to a blade attached thereto. The generator continues to impart electrical energy to convert to mechanical energy as it varies the frequency in an effort to find and drive the system at its resonant frequency. Equating the transducer and waveguide as an equivalent electrical model, as the frequency of cycling is increased, starting at a non-resonant condition below the desired resonant frequency, the system's oscillations first approach a frequency at which impedance is minimum (maximum admittance). This minimum impedance frequency approximates the series resonance frequency, the frequency at which impedance in an electrical circuit describing the element is zero (assuming resistance caused by mechanical losses is ignored). The minimum impedance frequency also is the resonant frequency of the waveguide and blade assembly, which by design is nominally the same resonant frequency of the transducer. The composition of the transducer material and the shape and volume of the waveguide and blade assembly determine the resonance frequency. As the cycling frequency is further increased, impedance increases to a maximum (minimum admittance). The maximum impedance frequency, approximates the parallel resonance frequency, the frequency at which parallel resistance in the equivalent electrical circuit is infinite (assuming resistance caused by mechanical losses is ignored). The maximum impedance frequency also is the anti-resonance frequency. The larger the difference between resonant and anti-resonant frequencies (that is, the frequency window or phase margin), the easier it is for a generator to establish and maintain resonance in the waveguide and blade assembly as frequency tolerances are relaxed. - In the present invention, the gain step described above may cause a significant acoustic impedance mismatch, causing some of the mechanical energy transmitted along the waveguide to be reflected. As is seen in
FIGS. 3 and 3 c, a gain in wave amplitude is caused by a thinner cross section in thewaveguide 80adjacent gain step 102. Atgain step 102, the change in thickness results in a lowering of the anti-resonant frequency after thestep 102. This results in a narrower frequency window or steeper trough between resonance and anti-resonance. A step up 103 results in an increase in waveguide cross-section or thickness that in part addresses manufacturing requirements. - Applicants have determined that locating the gain steps in the distal portion of the waveguide results in a greater phase margin or wider trough between resonant and anti-resonant frequencies. What is meant as the “distal portion” is the distal half of the waveguide. By delaying waveguide narrowing to the distal end of the waveguide, more mechanical energy is stored along the waveguide and any negative effects due to reflection at the gain steps are mitigated. It is appreciated that the gain step or combination step up/down/up may be located anywhere along the waveguide. For ideal system performance, however, the gain step(s) should be located in the distal half of the blade, preferably at the two most distal nodes in relation to the handpiece, or the two most proximal nodes in relation to the blade tip. Surprisingly, the Applicants found that the phase margin increased by almost 100% by relocating the gain steps to the distal portion of the waveguide. In early experiments of a waveguide having two gain steps, one at the proximal end and one at the distal end, the phase margin measured 30 to 40 Hz. In experiments of a waveguide having two gain steps, both located at the distal portion, the phase margin measured between 50 and 80 Hz. In experiments of a waveguide having two gain steps, one at each of the two most distal nodes, the phase margin measured between 75 and 80 Hz.
- In another embodiment (not shown), a single gain step is located at either the first or second most distal node in relation to the tip of the
blade 79 a. A single gain step may obviate the need for a step up and step down on the blade. To accommodate the hollow tip blade, thewaveguide 80 must be of sufficient cross section to transmit a wave from the handpiece to thefirst gain step 102 and the difference in diameters between the waveguide and the blade must be sufficient to result in the wave amplitude gain from a step down, step up and step down combination. The diameter difference must be large enough to achieve correct blade longitudinal excursion while providing a sufficient frequency window for the system to lock on to resonance. - Referring again to
FIG. 3 , awaveguide 80 andblade 79 combination is shown. In one embodiment, the overall length of the combination is 8.854 inches. Thefirst gain step 102 is located 6.139 inches fromproximal end 90. The step up 103 is located 6.922 inches fromend 90. Thesecond gain step 104 is located 7.912 inches fromend 90. Thebore 101 is 0.384 inches measured fromblade tip 79 a. - Referring now to
FIG. 3 c,graph 91 displays wave amplitude vs. blade distance and geometry. The y-axis represents wave amplitude given as a percentage of maximum displacement. The x-axis represents blade length. Thewave 92 represents the response or gain along the length due to the varying cross sections inwaveguide 80 andblade 79 discussed in reference toFIG. 3 . The points at which thewave 92 crosses the x-axis are referred to as nodes or vibration nodes. The points at whichwave 92 reaches maximum amplitude are referred to as antinodes. It can be seen that the first gain inwave amplitude 92 corresponds withgain step 102 and the second gain inwave amplitude 92 occurs atsecond gain step 104. - Referring to
FIG. 3 b,waveguide 80 may have a plurality of stabilizing silicone rings 80 a or compliant supports to prevent thewaveguide 80 from making contact with theinner tube 76 during activation. The silicone rings 80 a are ideally located at nodes on thewaveguide 80 as is known and understood in the art.Rings 80 a are preferably over molded onwaveguide 80 to ensure accurate location. A seal may be provided at the distal-most node, nearest the end-effector 81, to abate passage of tissue, blood, and other material in the region between thewaveguide 80 and actuatingmember 76. A silicone ring may not be sufficient at the most distal node of thewaveguide 80 in the instant embodiment of the present invention. As discussed above, thewaveguide 80 is provided with amplitude gain steps 102 and 104 that amplify the wave transmitted to theblade 79. The greatest deflection of the blade occurs at theblade tip 79 a. To facilitate tissue cutting in the proximal portion of theblade 79, a node support more rigid than silicon (a “rigid” support) is preferable to promote wave transmission to the blade to prevent wave absorption or losses and further provide more accurate dimensional stability of the blade deflection relative to theclamp arm 56. A rigid support may be useful in promoting higher clamp forces in the proximal portion ofblade 79 since a rigid support will not compress or yield at higher clamp forces as would silicone or like materials. - Referring back to
FIG. 2 and nowFIG. 3 d, ablade support 450 is shown. In a first expression of a first embodiment,support 450 is comprised of two pieces. Asleeve 451 preferably composed of a thermoset polymer is disposed aroundannular opening 452. The sleeve may be manufactured from bar stock resin such as VESPEL 211. Thesleeve 451 is then insert molded or pressed into a less expensivethermoplastic resin collar 453. Thecollar 453 is preferably composed of a filled thermoplastic resin with high thermal-conductivity, such as a filled PEEK. In this two-piece configuration, thesupport 450 is able to withstand the temperature and pressures associated with operation of theultrasonic blade 79 andwaveguide 80. In operation, when the blade is activated, heat built up in the blade is transferred through thethermoset polymer insert 451 to thecollar 453. Thecollar 453 transfers the heat tofins 454. Fins or supports 454 support thecollar 453 in the outer tube orsheath 72 and also transfer heat away from thecollar 453 and insert 451 into the void between theblade 79 and the actuatingmember 76. In a second expression of a first embodiment,blade support 450 is comprised of a thermoplastic resin, such as PEEK, of unitary construction. In a third expression of a first embodiment,blade support 450 is comprised of a thermoset polymer of unitary construction or a high temperature injection molded polyamide or compression molded materials of unitary construction. Other materials, such as ceramics and metals are also contemplated for theblade support 450 as is well known to the artisan. -
Ultrasonic transducer 50, and anultrasonic waveguide 80 together provide an acoustic assembly of the presentsurgical system 19, with the acoustic assembly providing ultrasonic energy for surgical procedures when powered bygenerator 30. The acoustic assembly ofsurgical instrument 100 generally includes a first acoustic portion and a second acoustic portion. In the present embodiment, the first acoustic portion comprises the ultrasonically active portions ofultrasonic transducer 50, and the second acoustic portion comprises the ultrasonically active portions oftransmission assembly 71. Further, in the present embodiment, the distal end of the first acoustic portion is operatively coupled to the proximal end of the second acoustic portion by, for example, a threaded connection. - With particular reference to
FIGS. 2 , 9 and 10, reciprocal movement of actuatingmember 76 drives theclamp member 60 open and closed. A force-limitingmechanism 95 is operatively connected to actuatingmember 76 and comprises atube collar 98 that securesdistal washer 97,wave spring 94, onto threadedcollar cap 93.Outer tube retainer 29 engages withopenings 75 in the proximal portion of tubular actuatingmember 76 via insulatedpin 27. Ashoulder 74 on the tube collar 78 receivesdrive yoke 33 for engagement with the inside surface ofouter sheath 72. - The
force limiting mechanism 95 provides a portion of the clamp drive mechanism of theinstrument 100, which affects pivotal movement of theclamp member 60 by reciprocation of actuatingmember 76. The clamp drive mechanism further includes adrive yoke 33 which is operatively connected with an operating trigger handle 34 of the instrument, with the operating trigger handle 34 thus interconnected with thereciprocable actuating member 76 viadrive yoke 33 andforce limiting mechanism 91. Trigger handle 34 is connected to driveyoke 33 and link 37 viapins Spring 12 is located betweendrive yoke 33 and handleassembly reciprocable actuating member 76 to the open position. - Movement of trigger handle 34 toward
handgrip 70 translates actuatingmember 76 proximally, thereby pivotingclamp member 60 towardblade 79. The scissor-like action provided by trigger handle 34 and cooperatinghandgrip 70 facilitates convenient and efficient manipulation and positioning of the instrument, and operation of the clamping mechanism at the distal portion of the instrument whereby tissue is efficiently urged against theblade 79. Movement of trigger handle 34 away fromhandgrip 68 translates actuatingmember 76 distally, thereby pivotingclamp member 60 away fromblade 79. - With particular reference to
FIG. 4 a, therein is illustrated one embodiment ofclamp member 60 for use with the present ultrasonicsurgical instrument 100 and which is configured for cooperative action with blade 79 (not shown). Theclamp member 60 in combination withblade 79 is commonly referred to as theend effector 81, and theclamp member 60 is also commonly referred to as the jaw. Theclamp member 60 includes a pivotallymovable clamp arm 56, which is connected to the distal end ofouter sheath 72 and actuation member 76 (not shown), in combination with a tissue-engaging pad orclamp pad 58. In one expression of the embodiment,clamp pad 58 is formed from TEFLON® trademark name of E. I. Du Pont de Nemours and Company, a low coefficient of friction polymer material, or any other suitable low-friction material.Clamp pad 58 mounts on theclamp arm 56 for cooperation withblade 79, with pivotal movement of theclamp arm 56 positioning the clamp pad in substantially parallel relationship to, and in contact with,blade 79, thereby defining a tissue treatment region. By this construction, tissue is grasped betweenclamp pad 58 andblade 79. As illustrated,clamp pad 58 may be provided with non-smooth surface, such as a saw tooth-like configuration to enhance the gripping of tissue in cooperation with theblade 79. The saw tooth-like configuration, or teeth, provide traction against the movement of the blade. The teeth also provide counter traction to the blade and clamping movement. As would be appreciated by one skilled in the art, the saw tooth-like configuration is just one example of many tissue-engaging surfaces to prevent movement of the tissue relative to the movement of theblade 79. Other illustrative examples include bumps, criss-cross patterns, tread patterns, a bead or sand blasted surface, etc. - Tissue pads having composite construction, while having benefits and advantages over TEFLON pads, have cost and manufacturing disadvantages. Composite tissue pads are typically compression molded into a flat coupon. Such compression molding can be time consuming and expensive. Once the flat coupon is produced, it must be machined to produce a tissue pad suitable for use with a clamping ultrasonic device adding further time and expense to the manufacturing process.
- With particular reference to
FIGS. 4 a and b, a first expression of the current embodiment includes aclamp pad 58 having aproximal portion 58 b and adistal portion 58 a that include a saw tooth like configuration.Clamp pad 58 may be a single component, which has anannular opening 58 c.Annular opening 58 c is configured to receivepad insert 58 d. The advantage of twoseparate components blade 79. Applicants found, in one experiment, that a 15% graphite-filled, 30% PTFE-filled polyimide tissue pad showed substantially the same or better wear with a 4.5 pound clamping force as a 100% polytetrafluoroethylene (PTFE) tissue pad showed with a 1.5 pound clamping force. The advantage of a 15% graphite-filled, 30% PTFE-filled polyimide tissue pad is increased heat resistance, which improves the overall wear resistance of the tissue pad. This polyimide-composite clamp pad has a useful heat resistance up about 800° F. to about 1200° F., as compared to a useful heat resistance up to about 660° F. of a PTFE clamp pad. Alternatively, Other materials are also useful for a portion of the tissue pad (that iselement 58 d), such as ceramics, metals, glasses and graphite. - In an alternate expression of the current embodiment,
clamp pad 58 includes aproximal portion 58 b that is smoother thandistal portion 58 a (not shown) wheredistal portion 58 a includes a saw tooth like configuration.Proximal portion 58 b may be devoid of saw-tooth-like teeth or other tissue engaging surfaces contemplated. Utilizing a smoothproximal portion 58 b onclamp pad 58 allows tissue in the proximal region to move distally, following the vibratory motion of the blade, to the more active region of theblade 79 to prevent tissue tagging. This concept takes advantage of the inherent motion profile ofblade 79. Due to sinusoidal motion, the greatest displacement or amplitude of motion is located at the most distal portion ofblade 79, while the proximal portion of the tissue treatment region is on the order of 50% of the distal tip amplitude. During operation, the tissue in the proximal region of end effector (area ofportion 58 b) will desiccate and thin, and the distal portion ofend effector 81 will transect tissue in that distal region, thereby allowing the desiccated and thin tissue within the proximal region to slide distally into the more active region ofend effector 81 to complete the tissue transaction. - In another expression of the current embodiment of the present invention,
clamp pad 58 a is formed from TEFLON® or any other suitable low-friction material.Pad insert 58 d is formed from a composite material, such as a polyimide. - In one expression of one embodiment of the invention, a
pad insert 58 d is formed from a cylinder of composite material. Referring toFIG. 4 c, a pad insert having a varying cross section is depicted.Pad 58 d may be a cylinder that is sized to press fit withinannular opening 58 c. Alternatively,pad insert 58 d maybe provided withcutout 58 d′. Thecutout 58 d′ is matched to a lip in annular opening in 58 c inpad 58. This lip-cutout arrangement facilitates easy insertion of thepad insert 58 d into thepad 58 and further promotes mechanical holding action of thepad insert 58 d in thepad 58. This mechanical holding action may obviate the need for welding, gluing and the like. In other embodiments, thepad insert 58 d may be cylindrical with varying steps in the bore to facilitate holding, may be of cylindrical cross section with increasing or decreasing diameter, or may be square, or rectangular and may be provided with barbs on the surface to facilitate holding in theclamp pad 58. Other embodiments may use glue or welding to hold thepad insert 58 d in place. In other embodiments, theclamp pad 58 may have multiple pad inserts located anywhere along the length of thepad 58. - Several benefits and advantages obtain from one or more of the expressions of the invention. Having a tissue pad with a base material and at-least-one pad insert material allows the base material and the at-least-one pad insert material to be chosen with a different hardness, stiffness, lubricity, dynamic coefficient of friction, heat transfer coefficient, abradability, heat deflection temperature, glass transition temperature and/or melt temperature to improve the wearability of the tissue pad, which is important when high clamping forces are employed because tissue pads wear faster at higher clamping forces than at lower clamping forces. Further benefits and expressions of this embodiment are disclosed in U.S. patent application, Ser. No. 11/065,378, filed on Feb. 24, 2005 and commonly assigned to the assignee of the present application.
- Referring to
FIG. 4 c, one expression ofclamp arm 56 is shown. In this configuration, the clamp arm is stamped from a single piece of material. This stamping process yields across section 56 a andflanges 56 a′ tapered inward to form a channel and adapted to receive a correspondingly shaped wedge orflange 58 e onclamp pad 58. This single piece stamping process has the advantage of rapid andinexpensive clamp arm 56 manufacture. Additionally,clamp arm 56 omits a pad stop that is found in traditional ultrasonic clamp arms and instead relies onweld pin 56 b (seeFIG. 4 a) to hold theclamp pad 58 in place further reducing manufacturing cost. - Although a single clamp arm is depicted,
clamp arm 56 may comprise a distal T-shaped slot for accepting a T-shaped flange of distal clamp pad and a proximal wedged-shaped or dove tailed-shaped slot for accepting a wedge-shaped flange of a proximal clamp pad as is known and understood in the art. As would be appreciated by those skilled in the art, flanges and corresponding slots have alternate shapes and sizes to secure the clamp pads to the clamp arm. The illustrated flange configurations shown are exemplary only and accommodate the particular clamp pad material of one embodiment, but the particular size and shape of the flange may vary, including, but not limited to, flanges of the same size and shape. For unitary tissue pads, the flange may be of one configuration. Further, other methods of mechanically attaching the clamp pads to the clamp arm, such as rivets, glue, press fit or any other fastening means well know to the artisan are contemplated. - A first expression of a method for replacing
clamp pads 58 would include one or more of the steps of: a) removingweld pin 56 b; b) removingclamp arm 56 fromouter sheath 72; c) removingclamp pad 58 from theclamp arm 56; c) removing apad insert 58 d from theclamp pad 58; d) inserting a clamp pad into aclamp arm 56; and e) engagingclamp arm 56 withouter sheath 72 viaweld pin 56 b. In this removal and replacement process, thenew clamp pad 58 inserted in step “d” may be of unitary TEFLON construction, may be of composite construction, may be multiple pieces of TEFLON or composite material or may contain a pad insert or any combination thereof. Pad insert may be a new pad insert or may be the pad insert from the “used” clamp pad. - A second expression of a method for replacing
clamp pads 58 would include one or more of the steps of: a) opening flanges on clamp arm 56 (seeFIG. 4 b); b) removingclamp pad 58 fromclamp arm 56; c) removingpad insert 58 d fromclamp pad 58; d) insertingpad insert 58 d into a clamp arm; and e) closing flanges onclamp arm 56. In this removal and replacement process, thenew clamp pad 58 inserted in step “d” may be of unitary TEFLON construction, may be of composite construction, may be multiple pieces of TEFLON or composite material or may contain a pad insert or any combination thereof. Pad insert may be a new pad insert or may be a pad insert from a “used” clamp pad. - A third expression of a method for replacing a clamp pad having a base material and at-least-one pad insert material would include one or more of the steps of: a) removing the clamp pads from
clamp arm 56; b) providing a new clamp pad having an opening at a proximal end thereof; c) inserting a pad insert sized to fit the opening into the opening; and d) attaching the clamp pad to the clamp arm. - Referring now to
FIGS. 2 , 4 a-b, 5 and 6, pivotal movement of theclamp member 60 with respect toblade 79 is affected by the provision of a pair of pivot points on theclamp arm 56 that interface with theouter sheath 72 andinner tube 76 respectively. Theouter sheath 72 is grounded to handle 70 throughouter tube retainer 29.Clamp arm 56 is pivotally connected toouter sheath 72 via corresponding throughholes clamp arm outer sheath 72.Pin 56 b slides through holes 52 a-d to secureclamp arm 56 toouter sheath 72. In oneembodiment pin 56 b is laser welded to clamparm 56 so thatpin 56 b is fixed to clamparm 56 and rotates relative toouter sheath 72. Any linear fastener will suffice and the invention is not limited to weld pin fastening. -
Inner tube 76 translates along the longitudinal axis ofouter sheath 72 and is grounded to thehandle 70 throughouter tube retainer 29.Legs 54 a,b onclamp arm 56 engageslots 54 c at the distal end ofinner tube 76. The pivotal connection ofclamp arm 56 to the inner andouter tubes end effector 81 and minimize failure modes due to excessive axial or torsional abuse loads. Further, the embodiment increases the effectiveness of theend effector 81 to provide clamp forces in excess of 5 lbs. Reciprocal movement of the actuatingmember 76, relative to theouter sheath 72 and thewaveguide 80, thereby affects pivotal movement of theclamp arm 56 relative to the end-blade 79. - In one embodiment of the present invention, the
inner tube 76 andouter sheath 72 are manufactured through rolled construction as is known and understood in the art. This rolled construction may result in significant cost savings over extrusion or other like manufacturing processes. Other manufacturing techniques, such as a drawn tube, are also contemplated herein. - Referring now to
FIGS. 1 , 2 and 7,housing 70 includes a proximal end, a distal end, and acavity 59 extending longitudinally therein.Cavity 59 is configured to accept aswitch assembly 300 and thetransducer assembly 50, which interfaces withhousing 68 viaswitch assembly 300. -
Transducer 50 includes a firstconductive ring 400 and a secondconductive ring 410 which are securely disposed within thehandpiece transducer body 50. In one expression of the current embodiment, firstconductive ring 400 comprises a ring member, which is disposed between thetransducer 50 and thehorn 130. Preferably the firstconductive ring 400 is formed adjacent to or as part of theflange member 160 within thecavity 162 and is electrically isolated from other electrical components. The firstconductive ring 400 is anchored to and extends upwardly from a non-conductive platform or the like (not shown) which is formed within thetransducer body 50. The firstconductive ring 400 is electrically connected to the cable 22 (FIG. 1 ) by means of one or more electrical wires (not shown), which extend along the length of thetransducer body 50 to the firstconductive ring 400. - The second
conductive ring 410 of thetransducer 50 similarly comprises a ring member that is disposed between the transducer body 150 and thehorn 130. The secondconductive ring 410 is disposed between the firstconductive ring 400 and thehorn 130 and therefore the first and secondconductive rings conductive ring 410 is likewise electrically isolated from the firstconductive ring 400 and other electrical components contained within thetransducer 50. Similar to the firstconductive ring 400, the secondconductive ring 410 preferably is anchored to and extends upwardly from the non-conductive platform. It will be understood that the first and secondconductive rings more spacers 413 disposed between the first and secondconductive rings rings transducer 50. The secondconductive ring 410 is also electrically connected to the cable 22 (FIG. 1 ) by means of one or more electrical wires (not shown), which extend along the length of thetransducer 50 to the secondconductive ring 410. The secondconductive ring 410 is thus provided to partially define a second electrical pathway from thecable 22 to theswitch mechanism 300. A suitableultrasonic transducer 50 is Model No. HP054, sold by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio. - In one expression of the current embodiment, the distal end of
transducer 50 threadedly attaches to the proximal end ofwaveguide 80. The distal end oftransducer 50 also interfaces withswitch assembly 300 to provide the surgeon with finger-activated controls onsurgical instrument 100. - With reference now to
FIGS. 8 a-c,switch assembly 300 comprises apushbutton assembly 310, aflex circuit assembly 330, aconnector assembly 350, a first springslip ring conductor 360 and a second springslip ring conductor 370.Connector assembly 350 is generally cylindrical and is supported withinhandle 70 by way of corresponding supporting mounts onswitch assembly 350 andhousing portions Connector assembly 350 defines afirst cavity 353, a mountingboss 352 and asecond cavity 351.Cavity 353 is sized to accept the proximal end oftransducer 50, wherebyhorn 130 passes throughcavity 351 to interface withwaveguide 80. Mountingboss 352 acceptsslip ring conductors ring contacts - With particular reference now to
FIG. 8 a,slip ring conductors connector assembly 350. Each spring slip ring comprises two pressure point contacts (361 a-b and 371 a-b) that contact therespective ring conductor transducer 50. The spring tension of the slip rings 360 and 370 cause positive contact between contacts 361 a-b, 371 a-b andconductors transducer 50 during use of the instrument.Posts 364 and 374 (not shown) of the respective slip rings electrically connect to the respective conductor withinflex circuit 330 to complete the electrical circuit as is known and understood in the art. - A
flex circuit 330 provides for the electro-mechanical interface betweenpushbuttons generator 30 viatransducer 50. Flex circuit comprises twodome switches pushbuttons corresponding pushbutton assembly 310. Dome switches 332 and 334 are electrical contact switches, that when depressed provide an electrical signal togenerator 30 as shown by the electrical wiring schematic ofFIG. 8 d.Flex circuit 330 also comprises two diodes within adiode package 336, also illustrated inFIG. 8 d.Flex circuit 330 provides conductors, 335 and 337 as is known to those in the art, that connect to slipring conductors electrical tabs conductors cable 22 that connect togenerator 30.Tabs 364 and 374 (not shown) are soldered toconductors -
Flex circuit 330 is partially folded and is generally fixedly attached inhandle assembly 68 so that dome switches 334 and 332 interface with backing surfaces on handle assembly 69 (not shown). Backing surfaces provide a firm support for the dome switches during operation, discussed below. Dome switches 334 and 332 may be fixedly attached to backing surfaces by any convenient method, such as, an adhesive. Flex circuit is secured toconnector assembly 350 via alignment pins 354 onswitch assembly 350 and corresponding alignment holes 338 onflex circuit 330. As is well appreciated by one skilled in the art various electrical constructions are available to provide electrical interface between the pushbuttons and the generator, which may include molded circuits or standard wire connections. - Layered on top of flex circuit is
pushbutton assembly 310, which has a corresponding saddle-shape asflex circuit 330.Pushbutton assembly 310 comprises two pushbuttons,distal pushbutton 312 andproximal pushbutton 311 which havecorresponding pressure studs push button assembly 310 comprises a rocker style pushbutton. Other types of switches, known to the skilled artisan, are equally applicable.Rocker pushbutton assembly 310 is rotationally attached to handle 70 to provide centering action to thepushbutton assembly 310. As is readily apparent, by depressingpushbuttons corresponding pressure studs FIG. 8 c.Switches switch 312, the generator will respond with a certain energy level, such as a maximum (“max”) power setting; when the surgeon depressesswitch 311, the generator will respond with a certain energy level, such as a minimum (“min”) power setting, which conforms to accepted industry practice for pushbutton location and the corresponding power setting. - Alternatively, the pushbuttons may be molded into the
connector assembly 350 or into thehandle assembly 68 to reduce the number of components and increase the reliability of the overall device. The pushbuttons may be attached through small cantilever sections, which allow for sturdy attachment of the pushbutton to the other components, while at the same time allowing for a low force to activate the pushbuttons. - In the foregoing embodiment of the present invention, switches 311 and 312 configured in such a way to provide an ergonomically pleasing grip and operation for the surgeon. Switches may be placed in the range of the natural swing of the surgeon's index or middle fingers, whether gripping
surgical instrument 100 right-handed or left handed. Referring again toFIG. 8 b, in a current embodiment a series of partitions, such asridges 312 a and/or depressions or “peaks and valleys” are integrated onto thepushbutton 312. The ridges provide tactile feedback to the surgeon as to the location of the pushbuttons and whether the button represents min or max power activation. Such tactile feedback is essential to the surgeon, so the surgeon may continuously assess the surgical site, but confidently understand which pushbuttons are being activated, without the need to view theinstrument 100. - Referring to
FIG. 9 , a surgeon's left hand is accessinginstrument 100. The thumb is poised to activate trigger handle 34, and the index and middle fingers easily engagepushbutton assembly 310. The surgeon's ring finger and pinkie grasp handle 70. - In
FIG. 10 , a right-handed the surgeon has depressed trigger handle 34 to closeclamp arm 56 againstblade 79. The right forefinger can easily accesspushbutton 312 to activate max power, and the left middle finger can easily access pushbutton 311 b to activate min power. It can be observed that the surgeon may use the index finger to activate max power and the middle finger to activate min power. The rocker type switch allows the surgeon to rest both fingers on the min and max buttons while ensuring that both buttons are not activated simultaneously. The rocker type switch facilitates rapid change of cutting speed from max to min, back to max, etc. In previous devices, the surgeon would have to move from a foot from one pedal to another, or move his or her finger from one button to another. In some instances, the surgeon would have to look away from the operative field to locate either the desired foot pedal or desired button. The rocker switch permits the surgeon to rest two fingers on the switches during all phases of surgery obviating the need to look at or search for the desired button. - Referring to
FIGS. 9 and 10 , an expression ofsurgical instrument 100 is shown graphically illustrating a surgeon's finger placement oninstrument 100. Closing of theinstrument 100 is achieved by the placement of the thumb through the opening 34 a in trigger handle 34 and depressing trigger handle 34. (Inserting the thumb through the opening 34 a to activate trigger handle 34 is exemplary only. Surgeons with larger hands may opt to activate trigger handle 34 with the thumb on the outside of trigger handle 34 and trigger handle 34 is provided withridges 34 b to enable use of the thumb or any other finger or part of the hand on the outside of trigger handle 34 during surgery).Opening 34 a is generally sized to accept different sized fingers and thumbs, a common variable as is evident depending upon the sex and size of the surgeon. - In an alternate expression of the invention, trigger handle 34 and grip handle 70 have a soft-touch molded thermo plastic elastomer liner (not shown) on their inner
surfaces defining openings - Referring now to
FIGS. 2 , 11 and 12, a one-piece torque wrench 500 is shown. Thetorque wrench 500, in one embodiment, is provided withcantilever arms 501 disposed in an annular fashion about the centerline oftorque wrench 500.Cantilever arms 501 includeteeth 501 a disposed, in one embodiment, in an inward perpendicular fashion in relation to cantileverarms 501.Teeth 501 a, in one embodiment of the current invention, are disposed with acam ramp 501 b at a 25° angle with respect to the perpendicular angle betweenarm 501 andteeth 501 a. - Referring now to
FIG. 12 , anouter tube retainer 29 is shown.Outer tube retainer 29 includes spline gears 29 a projecting in a perpendicular fashion along the outer circumference ofretainer 29. Spline gears 29 a include cam ramps 29 b disposed at a 25.6° angle with respect to the perpendicular angle between the outer circumference ofretainer 29 and spline gears 29 a. Other angles of the teeth and cam ramps are contemplated and left up to the designer. - In operation,
torque wrench opening 502 is aligned withouter sheath 72 and guided along substantially the entire length ofsheath 72.Torque wrench lip 503 engages the distal end ofhandgrip 70.Cantilever teeth 501 a slidably engage spline gears 29 a onouter tube retainer 29.Cam ramp 501 b slidably engages retainer cam ramps 29 b. Clockwise annular motion or torque is imparted totorque wrench 500 throughpaddles 504. The torque is transmitted througharms 501 andteeth 501 a to gears 29 a, which in turn transmit the torque to thewaveguide 80 via insulatedpin 27. When a user imparts 5-12 in-lbs. of torque and holds thehandpiece 50 stationary, theramps arms 501 to move or flex away from the centerline ofwrench 500 ensuring that the user does not over-tighten thewaveguide 80 onto horn 130 (FIG. 7 ). When a counter-clockwise torque is applied towrench 500 via paddles 504 (and holding thehandpiece 50 stationary), the perpendicular flat sides ofteeth waveguide 80 andhorn 130 in proportion to the force applied to the paddles facilitating removal of theinstrument 100 from thehandpiece 50. Thetorque wrench 500 may be constructed from a durable plastic, such as polycarbonate or a liquid crystal polymer. It is also contemplated that thewrench 500 may alternatively be made from a variety of materials including other plastics, ceramics or metals. - In another embodiment (not shown), the paddles and cantilever arm assembly may be separate components attached by mechanical means or chemical means such as adhesives or glue.
- Referring now to
FIGS. 2 , 5, 6 and 13,force limiting mechanism 95 provides awave spring 94.Wave spring 94 is operationally coupled toyoke 33, which in turn is driven bytrigger handle 34.Wave spring 94 generates the end effector load and maintains the consistency of the end effector load. As a result, the end effector load is more tightly controlled and component abuse load conditions are reduced. Mechanical interference or contact between trigger handle 34 and handle 70 are a safe guard againstwave spring 94 being fully compressed, thereby preventing the spring material to yield and renderwave spring 94 useless in subsequent clamp arm closures. As would be appreciated by one skilled in the art, the application of a mechanical stop spring force limiting system has applicability in other energy-based surgical devices (such as RF, microwave and laser) that encounter clamping forces, as well as mechanical devices, such as, clip appliers, graspers and staplers. - In one expression of the current embodiment,
wave spring 94 has a spring constant about 43 pounds per inch.Wave spring 94 is preloaded to a force necessary to achieve the desired transection force, and is a function of the mechanical advantage of theclamp arm 56 coupling means and frictional losses in the device. In a second expression of the current embodiment,wave spring 94 is preloaded at about 13 pounds. - Referring now to
FIG. 13 ,curve 82 illustrates trigger handle 34 force as a function of the angular rotation of trigger handle 34 for clamp arm closure andcurve 83 represents trigger handle force as a function of angular rotation of trigger handle 34 for clamp arm opening.Point 82 a represents the point at whichyoke 33 begins to deflect or compresswave spring 94 and the force increases as trigger handle 34 is depressed further until the force reaches the preload value ofwave spring 94 atinflection point 82 b, and the slope of the force curve decreases.Point 82 c represents trigger handle force where trigger handle 34 contacts handle 70 resulting in a mechanical stop. - In
FIG. 13 ,curve 83 illustrates the force exerted on the trigger handle 34 byspring 12.Point 83 a represents the point at which trigger handle 34 disengages fromhandle 70 andwave spring 94 andspring 12 both exert force againstyoke 33.Point 83 b represents the maximum force that triggerhandle 34 exerts against a user during the opening stroke of trigger handle 34 and clamparm 56. As can be appreciated bycurves FIG. 13 , less force is required to maintain the trigger handle 34 in a closed position than required to achieve the closed position. This difference in forces proves advantageous during long surgical procedures where hand fatigue may be a factor. For example, a surgeon may unknowingly relax pressure on the trigger handle 34 during a long transection; with lower forces required to keep trigger handle 34 fully closed, consistent cutting and hemostasis is achieved. - Referring now to
FIG. 2 ,surgical instrument 100 further provides for audible and tactile means for indicating to the surgeon that the trigger has reached full travel and theclamp arm 56 is applying the correct coaptation force to the tissue.Clicker 339 located inhandle 70 contacts triggerhandle tab 34 a upon closing or opening in a momentary fashion such thattrigger handle tab 34 a causes clicker 339 to yield and spring back to its original position resulting in an audible and tactile “click.” This is useful during protracted surgical operations or tissue transection activities when the surgeon's grip may relax, without the surgeon's knowledge, and the pressure delivered to the tissue from theclamp arm 56 may be unknowingly decreased. -
Clicker 339 is generally planar and made of a flexible plastic that adequately deflects when it engagestrigger handle tab 34 a thereby providing an audible and/or tactile signal to the surgeon that there isfull end effector 81 closure. Advantageously,tab 34 a strikes and deflectsclicker 339 when trigger handle 34 is rotated from the full closure position and in the opposite direction thereby providing an audible and/or tactile signal to the surgeon that full closure ofend effector 81 no longer exists. As would be appreciated by the skilled artisan, the indicating means may be either tactile, audible or visual or a combination. Various types of indicators may be used including dome switches, solid stops, cantilever springs or any number of mechanical or electrical switches known to those skilled in the art. Further various means may be used to provide feedback to the surgeon, including, but not limited to, lights, buzzers, and vibratory elements. - Preferably, the ultrasonic clamp coagulator apparatus described above will be processed before surgery. First, a new or used ultrasonic clamp coagulator apparatus is obtained and if necessary cleaned. The ultrasonic clamp coagulator apparatus can then be sterilized. In one sterilization technique the ultrasonic clamp coagulator apparatus is placed in a closed and sealed container, such as a plastic or TYVEK bag. Optionally, the ultrasonic clamp coagulator apparatus can be bundled in the container as a kit with other components, including a torque wrench. The container and ultrasonic clamp coagulator apparatus, as well as any other components, are then sterilized in any conventional medical sterilization technique, such as gamma radiation, x-rays, high-energy electrons or ETO (ethylene oxide). The sterilization kills bacteria on the ultrasonic clamp coagulator apparatus and in the container. The sterilized ultrasonic clamp coagulator apparatus can then be stored in the sterile container. The sealed container keeps the ultrasonic clamp coagulator apparatus sterile until it is opened in the medical facility.
- While the present invention has been illustrated by description of several embodiments, it is not the intention of the applicant to restrict or limit the spirit and scope of the appended claims to such detail. Numerous variations, changes, and substitutions will occur to those skilled in the art without departing from the scope of the invention. Moreover, the structure of each element associated with the present invention can be alternatively described as a means for providing the function performed by the element. Accordingly, it is intended that the invention be limited only by the spirit and scope of the appended claims.
Claims (14)
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