CN102811676A - Medical heating device and method with self-limiting electrical heating element - Google Patents

Medical heating device and method with self-limiting electrical heating element Download PDF

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Publication number
CN102811676A
CN102811676A CN2011800120169A CN201180012016A CN102811676A CN 102811676 A CN102811676 A CN 102811676A CN 2011800120169 A CN2011800120169 A CN 2011800120169A CN 201180012016 A CN201180012016 A CN 201180012016A CN 102811676 A CN102811676 A CN 102811676A
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tissue
probe
temperature
firing equipment
medical
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CN2011800120169A
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CN102811676B (en
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泰·C·程
埃尔伯特·T·程
杰奎琳·T·程
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Curo Medical Inc
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Curo Medical Inc
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Priority claimed from US12/652,262 external-priority patent/US9044232B2/en
Priority claimed from US12/783,714 external-priority patent/US8512335B2/en
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    • 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
    • A61B18/08Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • A61B18/082Probes 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
    • A61B18/04Surgical 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
    • A61B18/1402Probes for open surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • 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
    • A61B18/1477Needle-like probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320069Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic for ablating tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/32007Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with suction or vacuum means
    • 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
    • A61B2018/00053Mechanical features of the instrument of device
    • A61B2018/00059Material properties
    • A61B2018/00071Electrical conductivity
    • A61B2018/00083Electrical conductivity low, i.e. electrically insulating
    • 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
    • A61B2018/00053Mechanical features of the instrument of device
    • A61B2018/00059Material properties
    • A61B2018/00089Thermal conductivity
    • A61B2018/00101Thermal conductivity low, i.e. thermally insulating
    • 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
    • A61B2018/00053Mechanical features of the instrument of device
    • A61B2018/00107Coatings on the energy applicator
    • A61B2018/00136Coatings on the energy applicator with polymer
    • 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
    • A61B2018/00595Cauterization
    • 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
    • A61B2018/00696Controlled or regulated parameters
    • A61B2018/00702Power or energy
    • 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
    • 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
    • A61B2018/00821Temperature measured by a thermocouple
    • 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
    • A61B2018/00875Resistance or impedance
    • 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
    • A61B2018/1405Electrodes having a specific shape
    • A61B2018/1425Needle
    • 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
    • A61B2018/1869Surgical 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 with an instrument interstitially inserted into the body, e.g. needles

Abstract

Miniaturized, handheld medical heating devices utilize an electrical heater formed from a self-limiting conductive material, such as a conductive polymer or ceramic. The material has an electrical resistance that gradually changes with temperature such that heat production from electrical current through the material varies the resistance. A thermally insulating jacket contains the self-limiting heater element, which can be coupled to an electrical power supply. In one embodiment, a probe thermally coupled to the heater extends outward from the jacket. In another embodiment, the self-limiting conductive material is in series with one electrode of an electrode pair (or three electrodes) adapted to deliver radio frequency energy to tissue.

Description

Medical firing equipment and method with self limiting electrical heating elements
The cross reference of related application
The application is the application number 12/652 that is filed on January 5th, 2010; 626 (attorney docket 028486-000100US) and be filed in the application number 12/783 on May 20th, 2010; The part continuation application of 714 (attorney docket 078486-000200US), the complete disclosure of above-mentioned application is incorporated into this by reference.
Background of invention
are technical field 1..Present invention relates in general to armarium and method, particularly, relate to the medical firing equipment that comprises the probe that target tissue is heated for ablation of tissue, tissue cutting or tissue dwindle, and relate to energy supply and control this kind equipment.
are Description of Related Art 2..The medical treatment firing equipment is used for tissue treatment at present and melts in many therapeutic schemes.Usually, induct electric arc or of the radio frequency between using at 2 through generating heat to the grounding apparatus conductive electric current through health.This type of probe can burn tissue melting, cut or dwindle when organizing.Cautery is to produce conduction of heat and process that tissue is sealed through the current flow heats metal probe, and wherein heating has stoped the hemorrhage of the blood vessel in the soft tissue.Interested related patent U.S. Patent No. and openly comprising: U.S. Patent number 4,026,300; 4,411,266; 5,190,517; 5,345,305; 5,554,679; 6,039,734; 6,132,426; 6,139,545; 6,312,392; 6,451,011; 6,770,072; 7,220,951; 7,309,849; 7,476,242 and 7,483,738; US publication 2007/0167943; PCT publication number WO2006/009705 and WO2008/014465; And people (1985) Urol Res 13:99-102 such as Ramsay; People such as Hernandez-Zendejas (1994) Aesth Plas Surg 18:41-48; People such as Utley (1999) Arch Facial Plast Surg 1:46-48; And Newman (2009); " Radiofrequency Energy for Denervation of Selected Facial Muscles:Clinical Experiences at Six Months "; The Internet Journal of Plastic Surgery; Volume 5, and Number 2.
Electrosurgery applies high frequency, the electric current of radio frequency often to tissue, as tissue is cut, solidifies, the dry or means of fulgerizing.Its benefit comprises can carry out clean cut and lose blood limited.Electrosurgery also comprises such surgical procedure: wherein use high-frequency alternating current to generate heat, thus the one or more partial part of ablation tissue, and do not heat tissue near the other types of target tissue.Electrosurgery equipment uses the probe spline structure to come physically to contact target tissue, and wherein this class formation can be to play the electrode type that electric current is reached the effect of tissue.Electrosurgery equipment causes significant physical injury to tissue usually.
With (based on electric arc) relevant problem of electrosurgery firing equipment is the danger that electrical fire may take place in medical clinic, operating room or hospital.Conduction of current equipment passes the fully control of path shortage that tissue arrives ground connection to electric current from power supply.The tissue that is produced adds heat and also is difficult to control, thereby causes the unnecessary damage as the treatment side effect potentially.
The medical firing equipment of other types uses by switch or the thermostatically controlled resistor-type electrical heating elements of thermocouple.These equipment are basically through complete opening or close electrical heating elements fully and control heat production and probe temperature, thereby cause the temperature fluctuation of the ablation probe or the cutting probe of armarium, and this is not best for ablation of tissue or tissue cutting purpose.
Nerve is bigger cell.Each neurocyte comprises cell space, a plurality of dendron, aixs cylinder fiber and a plurality of axon terminal.Cell space is neural middle body, and it comprises the nucleus of cell.The diameter range of cell space can from 4 to 100 microns.Aixs cylinder and dendron are from the outward extending filamentous of cell space.Usually, many dendrons are around cell space and branch and going out from it, and have the length that reaches the hundreds of micron.Aixs cylinder is outstanding from the outward extending single cable shape of cell space, and it can extend beyond 100 times of cell space diameter.Aixs cylinder carries the electrochemistry nerve signal from cell space, to control one or more muscle effectively.Axon terminal is positioned at the opposite of the cell space end of aixs cylinder.Usually; Axon terminal ends among the branching networks of synapse; Synapse discharges chemical substance so that communicate with one or more muscle or its hetero-organization, perhaps with perhaps other dendrons or the cell space of intrachain another neurocyte of neurocyte of its hetero-organization communicate from leading to one or more muscle.
Usually, from the number of axons of many cells in big pipeline boundling together, this pipeline is called epineurium, portion has other nested pipeline within it.From being called as of direct each aixs cylinder of encirclement endoneurial internal pipeline or sheath, the physiological structure of these pipelines is analyzed.A plurality of aixs cylinders are assembled bunchy usually together, and further receive the protection that is called perinenrial middle level sheath.In addition, the aixs cylinder of a plurality of perineurium bundles is nested in usually and is called in the epineurial epitheca.Therefore, each aixs cylinder obtains at least three sheath layers from the outermost layer to the innermost layer, that is, and and epineurium, perineurium and endoneurial protection.Notice that each large pipeline or epineurium comprise many bundle endoneurium pipelines, therefore, might cut off the aixs cylinder of some neurocytes fully, and it is excellent to keep the complete endoneurium of other neurocytes.
It is the basic classification system that is used to describe nerve injury that plug is stepped on system (Seddon system), and three types of damages are wherein arranged---neural apraxia, aixs cylinder are interrupted and neurotmesis.With regard to neural apraxia, the integrity of aixs cylinder has obtained reservation, so endoneurium, perineurium and epineurium are all excellent, interrupt but in the conduction of the electrochemistry pulse descending along aixs cylinder, exist.This is the slightest nerve injury form.The biochemical lesion that neural apraxia is normally caused by the concussion damage of pair cell.Have temporary afunction, this can reverse in several hours to the several months (average 6 to 8 weeks) of damage.
With regard to aixs cylinder is interrupted, the destroy integrity of aixs cylinder, but endoneurium, perineurium and epineurium do not receive and puncture significantly or be out of shape.Normally forfeiture motor function and sensory function time of result, but with the recovery that obtains through axon regeneration---this be one with the process that every day, given pace took place, recover usually than the neural longer time of apraxia cost.With regard to neural apraxia and aixs cylinder interruption, intact endoneurium is that axon regeneration provides guiding, and wherein nerve is regenerated along the endoneurium tubule.
On the contrary, with regard to neurotmesis, the integrity of supporting construction is destroyed or is punctured, thereby it is long and replant to have interrupted axon regeneration.Usually, source of damage from the serious contusion of cell, pull or laceration, perhaps be enough to endoneurium, perineurium or epineurium are caused the inner destruction of interferential other cellularity.The result is completely losing of motor function, sensory function and autonomic nervous function normally.Therefore, electrochemical signals can't completion and being connected of muscle or target tissue.Neurotmesis is normally nonvolatil.
Comparatively speaking, the neurotmesis of temporary pattern is derived from and is injected into neurocyte usually or is expelled near the neurotoxicity that local anesthetic caused of neurocyte.Anesthetis has also interrupted mailing to the electrochemical signals of muscle, thereby causes the forfeiture of motor function, sensory function and autonomic nervous function.The employed Botulinum toxin of popular wrinkle-removal cosmetic art or
Figure BDA00002090894900041
are used as neuromodulator; It acts on neuromuscular junction with the conduction between block nerves and the muscle, thereby causes muscular paralysis to reduce wrinkle.
Owing to these reasons, expectation provides self limiting medical treatment firing equipment, and this equipment improves simultaneously tissue is added the control of heat and to control of position and improve the safety for patient and operator.Also expectation provides such ability: produce the cell injury from the neural apraxia of minimum level to the various degree of complete neurotmesis through the current flow heats device, simultaneously its hetero-organization in the target area is caused the minimum physical injury same period.Also expecting provides temporary effect or nonvolatil alleviation and does not have surface texture open defect to the patient.The present invention of the following stated will satisfy at least some targets in these targets.
Summary of the invention
In first aspect of the present invention, medical firing equipment has by the formed resistive heater of self limiting conductive material.The self limiting conductive material can be conducting polymer or conducting ceramic material; It is characterized in that the resistance that changes with temperature; Thereby the heat production of the electric current of feasible this material of process preferably changes with temperature automatically, temperature is controlled at the target control value place perhaps near target control value.Shell---normally insulating jacket---comprises at least a portion of heating element, and this heating element can for example be coupled to usually the also power supply among shell through wiring.The heat conduction probe stretches out from chuck or other shells, and is thermally coupled to electrical heater element.The medical treatment firing equipment can be used for such method: wherein; Terminal or other exposed surfaces of probe touch target tissue; The heating ablation, the nerve that are used for tissue are removed, cut or are dwindled, if perhaps probe is a hollow pipe, then are used for applying the material through heating to target tissue.The temperature of probe has self limiting because of the temperature dependency resistance of the conductive material that is used for heating element, so equipment has the operative temperature of " automatic control ", and minimizing or avoided superheated and/or the underheat to target tissue.
In second aspect of the present invention, stride target tissue and apply radio frequency or other high-frequency electric fields, thereby cause electric current to pass through said target tissue and " conduction ".Produce heat through Ohmic heating or joule heating and from this electric current, wherein consequent heat and this magnitude of current square proportional.Be heated to above the normal temperature part at tissue and created " damage zone ".Heating takes place with good controlled way, and wherein the temperature of damage zone can not rise above maximum temperature.The heating of careful control can cause the accurate cell injury of expectation.Heat production in the damage zone by with target tissue in the self limiting conductive material electricity assembly that is connected in series of electric current electricity control.Self limiting conductive material electricity assembly is accurately controlled and is striden the mobile electric current of target tissue.
Heat production in the tissue and temperature raise and are directly proportional with the amount of the high frequency electric that directly passes tissue; The persistent period and the degree of the temperature that wherein raises; Position and size together with damage zone; Mainly determine the type and the degree of cell damage together, and this transfers the accurate cell injury whether decision obtains to expect.Therefore, the present invention uses accurate high frequency electric to control to produce and realizes to patient's the needed accurate floor level cell injury of expected result and do not surmount this level, thereby under the situation that does not have unnecessary cell injury, realizes this result.
The present invention can be used for medical use, dental applications or veterinary applications.Illustrative embodiments of the present invention has cosmetic applications, comprises wrinkle treatment and subcutaneous tissue reconstruct.Illustrative embodiments also is used for therapeutic to be used, and comprises the treatment of muscle spasm and chronic pain and to the control of one or more muscle of other target tissues.Illustrative embodiments is designed to specifically affect the nerves tissue, the cell injury of its desired be will be temporarily or permanently " paralysis " neural or cut off and cause the electrochemistry of neural contractile function to muscle to be connected between nerve and the muscle.Yet; Along with manufacturing technology changed with the epoch; Probe/probe on apparatus of the present invention can be processed to the size that the size with interested specific cells matches; Thereby the present invention can be used for causing the accurate cell of expectation to decrease to the cell of any kind in the body that matches with probe/probe size or organ, and wherein cell can be known or unknown any kind human cell.Other special-purposes comprise cautery, that is, through apply heat stop hemorrhage, and through the paralysis nervi trigeminus treat migraine.
Therefore the present invention provides high-frequency ac armarium and method for using thereof.This armarium can be battery powered hand-held low-power small generator, and it can combine high-frequency alternating current and unidirectional current transmission with the electric current of self limiting conductive material control.High-frequency ac armarium according to the present invention comprise power supply, field generator, self limiting conductive material electricity assembly, at least one probe or pin type protuberance and be positioned at said at least one probe or pin type protuberance at least two conductive segments.These at least two conductive segments are electrically connected to said field generator, so that between said conductive segments, produce electric field, thereby operate with bipolar fashion.Field generator is inducted in said target tissue or is generated the electric current that exchanges character, and this electric current generates heat and in some target tissue such as nervous tissue, causes the accurate cell injury of certain expectation.Field generator can also produce the non-therapeutic pulse, and said non-therapeutic pulse is through luring nerve into and contract muscles or demonstrating another observable reaction and neurocyte is detected before handling in treatment.The accurate cell injury of expectation can be neural apraxia to neurotmesis fully, temporarily or for good and all cuts off therefrom to cause the electrochemistry of neural contractile function to muscle to be connected between nerve and the muscle.Self limiting conductive material electricity assembly allows this type of accurate cell injury through being connected in series with the said electric current electricity that passes said target tissue; This is because the said electric current in the said self limiting conduction electric component control target tissue; Thereby prevent the superheated of target tissue, and the build-in attribute through the self limiting conductive material changes its electrical conductivity with temperature and realizes this point.Self limiting conductive material electricity assembly on electricity, show similar critesistor, thermocouple or switch.The self limiting conductive material can be positive temperature coefficient (PTC) material, negative temperature coefficient (NTC) material, zero-temperature coefficient (ZTC) material or its combination.The high-frequency ac armarium may diminish to be enough to hand.Power supply, field generator, self limiting conductive material electricity assembly, at least one probe or pin type protuberance and at least two conductive segments can be integrated into an equipment; This equipment is light and small and exquisite, is enough to cosily grip and handle very effectively to carry out surgical operation by the surgeon.
Therefore, in a particular aspects of the present invention, medical firing equipment comprises hand-held housing, and it limits inner, and this inside has held: power supply; The part of heat conduction probe, this part is from an end of shell---normally far-end---extends out, and has tissue contact tip far away; And temperature varying coefficient (TCC) element, it is positive temperature coefficient (PTC) element or combination type negative temperature coefficient (NTC) and zero-temperature coefficient (ZTC) element normally, and it provides resistance variations in response to variations in temperature; When adopting PTC, normally increase; Wherein, the scope of resistance variations be from 2 to 4 one magnitude, and the scope of variations in temperature is from 20 ℃ to about 100 ℃; Normally from 30 ℃ to about 80 ℃, but can adopt bigger variations in temperature in some applications.In other words, when the temperature of TTC material changes 1 one magnitude in these temperature ranges, be that resistance value that unit is measured will increase (perhaps reducing in other cases) 2 usually to 4 one magnitude with ohm.Electric current causes material temperature to rise through the TTC element, and the heat conduction probe is coupled to the TTC element so that heat is contacted far-end from the tissue that the TTC element conducts to the heat conduction probe.By this way, the tip far away of probe can contact against tissue, so that be transmitted in the heat that generates in the TTC element.Along with heat conducts along probe, the temperature of TTC material will be cooled off, thereby causes the reduction of resistance in the ptc material.Such as the application's book hereinafter discussion, when resistance reduced, the electric current of the PTC that flows through will increase, thereby temperature is recovered to the flex point of PTC curve (Fig. 8).
The medical treatment firing equipment preferably includes to have like the PTC element of specific composition hereinafter described here.The example power supply will be a dc-battery, and the example shell will comprise insulating jacket.The PTC element can be taked various ways.For example; The form of PTC element can be around core electricity partition at least one coil on every side; Wherein the effect of electric partition is that some zones that electricity is isolated the PTC element are electrically connected to said power supply with other zones of said PTC element simultaneously, thereby forms the current path through the length of coil.Perhaps, the form of PTC element can be to be rolled in core electricity partition thin slice on every side, and wherein the opposite end of thin slice is connected to power supply so that the current path through whole thin slice is provided.The 3rd, the form of PTC element can be such elongate coil: it has and passes itself or the longitudinal channel that on it, extends, so that the PTC element is connected to power supply.Heat conduction probe can be taked various ways, and it is needle probe normally, be alternatively have multiple round-shaped in the hollow pipe of any shape.Perhaps, probe can have the tip far away of atraumatic, and this tip far away can be circle, spin, blunt nosed, or the like.
Above-described medical firing equipment can be used for transmitting heat to tissue location.Electric current passes TCC or PTC element from power supply, thus heating TTC or PTC element.The tissue contact distal engagement of heat conduction probe is against target tissue site, and heat then is transmitted to tissue.As stated, the transmission of heat causes probe cooling, this then cause the cooling of PTC element, thereby reduce its resistance.When resistance reduced, electric current will increase, thereby generated more heat and the PTC element is recovered to flex point.
Of the present invention further aspect, high frequency medical treatment firing equipment comprises hand-held housing, this shell has the inner chamber that is suitable for holding the various device assembly.Power supply and field generator all are received in the enclosure.Field generator draws electric current from the power supply that is generally battery, and generates radio frequency (RF) electric current or other high frequency electrics.At least one tissue probe is coupled to hand-held housing and has two conductive segments (perhaps on two or more tissues probes, having a conductive segments alternatively) above that, and wherein conductive segments is adaptive is used for RF energy joint and is sent to tissue.Temperature varying coefficient (TCC) material preferably with similar positive temperature coefficient (PTC) element of above-mentioned material, also is installed in the hand-held housing, and is connected between field generator and the power supply.When the segmentation of field generator conductive transmits more energy, will increase through the electric current of PTC element, thereby cause its heating and raise the temperature.The raising of temperature will reduce to be sent to the electric current of field generator, thus reduce electric current and with Current Control in the desired destination level.
Of the present invention one preferred aspect, can tissue probe be provided on such assembly: this assembly is connected to shell removedly or removably, thereby makes different tissue probes can be attached to shell interchangeably.For example, the assembly of the tissue probe with single tissue probe, a pair of tissue probe or three tissue probes can be provided, thereby make them can be connected to hand-held housing interchangeably.In some cases, the tissue probe can be a tissue penetration property, to be used for treatment.In other cases, tissue probe can be non-tissue penetration property, particularly when handheld device be particularly like this when being used to excite nerve.Under these circumstances, field generator will be used for optionally transmitting certain type of RF energy or the dc energy with amplitude by adaptive---and direct current normally, this will stimulate nerve when organizing probe engages against patient's skin.This is particularly conducive to nerve is positioned, and can after the assembly of will popping one's head in is replaced with tissue penetration property probe assembly, come this nerve is handled with the RF energy then.
Description of drawings
Figure 1A is the perspective view of example hands spare, and this hands spare comprises self limiting electrical heating elements, insulating jacket, cutting probe and is connected with the circuit of power supply.Figure 1B and Fig. 1 C are the alternative perspective views according to hands spare of the present invention.
Fig. 2 A and Fig. 3 A are respectively the partial cut-away perspective view of distal probe of first embodiment and second embodiment of medical firing equipment, and it illustrates two kinds of different heating element heaters and arranges.Fig. 2 B and Fig. 3 B are the cross-sectional views of Fig. 2 A and Fig. 3 A.
Fig. 4 and Fig. 5 are respectively the partial cut-away perspective view of distal probe of the 3rd embodiment and the 4th embodiment of medical firing equipment, and it illustrates the interpolation of the replaceable probe module among Fig. 4 and the interpolation of the optional pick off among Fig. 5.Fig. 5 A is the cross-sectional view of Fig. 5.
Fig. 6 is the circuit diagram of medical firing equipment.
Fig. 7 is the logarithmic chart of the resistance (ohm) of preferred PTC self limiting electrical heating elements with temperature (C) change curve.
Fig. 8 is that the resistance (ohm) of PTC self limiting electrical heating elements is with the comparison with the logarithmic chart of temperature (C) change curve of the resistance (ohm) of the logarithmic chart of temperature (C) change curve and on/off switch.
Fig. 9 A, Fig. 9 B, Fig. 9 C and Fig. 9 D have described the logarithmic chart of the resistance (ohm) of NTC, ZTC, NTC/ZTC admixture and PTC/ZTC admixture with temperature (C) change curve.
Figure 10 is that resistance with various conducting polymer base materials of different polymer softening point (with respect to the resistance under 25 ℃) with the logarithmic chart of temperature (C) change curve, is used for using and select suitable conducting polymer materials to specified ablation of tissue or tissue cutting.
Figure 11 is the circuit diagram with basic model of two probes or the armarium of pin type protuberance.
Figure 11 A is the circuit diagram with basic model of a probe or the armarium of pin type outthrust.
Figure 12 is the circuit diagram of the example armarium of constructing according to the principle of the invention.
Figure 13 has illustrated attached and has removed the perspective view of the example armarium of replaceable tip, with the enlarged drawing of every kind of situation.Figure 13 A shows alternative replaceable tip, and it has the non-penetrative electrode, is intended to be used for the nerve stimulation on skin surface.
Figure 14 A is the cross-sectional view of armarium.
Figure 14 B is the vertical view of armarium.Figure 14 B also defines transversal plane 14A.
Figure 14 C is the cutaway view of Figure 14 B.
Figure 15 is the amplification to the side elevational view of the far-end of armarium.
Figure 16 is the amplification to the vertical view of the far-end of armarium.
The specific embodiment
The present invention provides a kind of armarium and method for using thereof.Armarium according to the present invention be included at least one probe or the pin type protuberance of its far-end and be positioned at said at least one probe or pin type protuberance at least two conductive segments.At least one probe or pin type protuberance can be inserted in body cavity or the bodily tissue, when the time comes can also be between said at least two conductive segments conductive electric current.In " single probe or pin type protuberance " pattern, said at least two conductive segments are positioned on unique probe or the pin type protuberance.In " two probes or pin type protuberance " pattern, be usually located at one of in said at least two conductive segments on each in two probes or the pin type protuberance.Probe or pin type protuberance are inserted in the tissue or body cavity that comprises target cell usually, perhaps are inserted near this type of tissue or the body cavity; Then conductive electric current between said segmentation is so that cause the accurate cell injury of expectation.Probe or pin type protuberance can be inserted in the tissue, thereby make electric current in subcutaneous generation.In this way, the damage field that heat limits is subcutaneous fully, thereby the outward appearance on the tissue surface is caused minimum change.Armarium also comprises power supply, and this power supply can be striden said at least two conductive segments and applied treatment or diagnose effective electric field, so that in target tissue, generate appropriate current.Power supply can be alternating current and/or unidirectional current.
In specific implementations, armarium also comprises field generator, and this field generator can be supplied power by said power supply, and generates one or more electric fields of striding said at least two conductive segments.Preferably, field generator is small but excellent little.Electric field can generate with the continuous wave form, and said continuous wave form is such as having sine wave, triangular wave or square wave etc., and generates with various frequencies, intensity and polarization, thereby causes the accurate cell injury expected so that produce the heating of expectation.Perhaps, electric field can also have DC pulse character, such as sine wave, triangular wave or square wave or similar pulse shape.Field generator can send some kinds of difform pulses and continuous wave simultaneously.The example field generator can be as small as and is enough to hand-held but can also uses hand-held dc-battery power supply that 3 watts electric field is supplied in 150 ohm with 460KHz, obtains transmitting although have more or less power according to battery strength and other conditions.
Armarium of the present invention also comprises the self limiting conductive material electricity assembly that is connected in series with the said electric current electricity that passes target tissue.The definition of " self limiting conductive material " is: the material that its resistance attribute becomes with its temperature.The function class that self limiting conductive material electricity assembly is brought into play on electricity is similar to occasionally switch of critesistor in the electric heating circuit of target tissue, thermoelectricity.In fact, the electric current of target tissue is passed in the control of self limiting conductive material electricity assembly, and thereby control target tissue and target tissue temperature of tissue surrounding.Particularly like the following stated, preferred self limiting conductive material is provided, the temperature response curve that it has critesistor is advantageously used among the equipment of the present invention.
Whole armarium may diminish to be enough to hand.Power supply, field generator, self limiting conductive material electricity assembly, at least one probe or pin type protuberance and at least two conductive segments can be integrated into an equipment (being in the total shell); This equipment is light and small and exquisite, is enough to cosily grip and handle very effectively to carry out surgical operation by the surgeon.
(Fig. 1-Fig. 5) comprising: self limiting electrical heating elements 20, it connects 40 through cable circuit and is coupled to power supply 30 (Fig. 6) medical treatment firing equipment 10.Such as hereinafter discussion, medical firing equipment 10 also comprises: insulating jacket 50, heat conduction probe 60 and core electricity partition 70.
The standard electric heating element heater that self limiting electrical heating elements 20 shows similarly on electricity and critesistor is connected in series.Therefore, in Fig. 6, self limiting electrical heating elements 20 is represented by the electrical heating elements symbol 26 that is connected in series with critesistor symbol 23.In fact, the critesistor attribute is regulated and control the electric current through electrical heating elements.In reality, institute more describes in detail like hereinafter, and self limiting electrical heating elements 20 is electric assemblies, mainly comprises the different materials even admixture of (comprising base material and conductive dopant).
Self limiting electrical heating elements 20 show similar electrical heating elements 26, this is because heat that it produced mainly comes from electronics, ion or the collision of other charged particles that occurs in the heating element heater.This type of pyrogenicity collision is caused by the electric field of striding heating element heater, and this electric field then is to be connected 40 by the cable circuit that connects the power supply 30 with voltage V and electric current I through heating element heater to cause.See Fig. 6.This phenomenon is called as Ohmic heating, joule heating or resistance heated.With regard to Ohmic heating, square proportional by heat Q that the present invention produced and the electric current that passes self limiting electrical heating elements 20, that is, and Q ≈ I 2
Self limiting electrical heating elements 20 show similar critesistor 23, this is because its resistance R changes as the function of temperature T, and this is the definition of critesistor.Because this relation is normally nonlinear, therefore use the logarithmic scale of resistivity to illustrate relation (Fig. 7-Figure 10) of itself and temperature.If resistance increases with increase in temperature, then device is called as positive temperature coefficient (PTC) critesistor or posistor.If resistance reduces with increase in temperature, then device is called as negative temperature coefficient (NTC) critesistor.Resistor is designed on wide temperature range, to have constant resistance, and is called as zero-temperature coefficient (ZTC) material sometimes, and this can be another subclass of critesistor.At this, PTC, NTC and ZTC material are referred to as temperature varying coefficient (TCC) material.
The attribute of Ohmic heating and temperature-responsive resistance is regulated and control the temperature of self limiting electrical heating elements 20 jointly.The variations in temperature of the medical cutting equipment that causes through use equipment causes changes in resistance.Resistance and electric current are inversely proportional to, that is, and and R ≈ I -1As stated, heat that is produced and I 2Proportional, thereby, Q ≈ 1/R -2Therefore, the little variation of resistance causes the heat production of self limiting electrical heating elements 20 that relatively large variation is arranged.Yet, there is maximum R, resistance becomes excessive at this maximum R place, so that can't allow the circuit between power supply is aspect 20 heating element to be connected.Be higher than this temperature, heater can turn-off, thereby causes quick cooling.
In specific and preferred implementation, self limiting electrical heating elements 20 is processed by ptc material.Fig. 7 is the curve chart of the resistivity of the ptc heater material that is suitable for using in the present invention to temperature.Suitable method has with temperature increased resistance rate gradually, like curve chart middle part (between T LWith T HBetween) shown in the positive slope characteristic.In addition, in the curve chart at T 0There is flex point in the place.When rising to, temperature is higher than T 0The time, resistivity increases with decrescence speed with temperature.Thereby, when rising to, temperature is higher than T 0The time, when heat production, exist the gentleness that takes place with decrescence speed to reduce.When temperature is brought down below T 0The time, resistivity reduces with decrescence speed with temperature.Thereby, when temperature is brought down below T 0The time, when heat production, exist the gentleness that takes place with decrescence speed to increase.With reference to Fig. 7, from T 0To T HResistivity increases gradually, thereby reduces heat production, thereby T is got back in the heating element cooling 0Likewise, from T 0To T LResistivity reduces gradually, thereby increases heat production, thereby heater element heats is got back to T 0At T 0There is temperature spot stable on the mathematics in the place, and it is called flex point again.Material producing with this flex point relation bears optkmal characteristics of the present invention, thereby its stability maintenance equipment with optimum stably is arranged on T 0Therefore, when ptc heater is placed on by force to the electric field that is enough to generate heat-generating current at it, can carries out " automatic temperature-adjusting control " or have inherent equilibrium temperature T 0In addition, steady temperature is striden from the fluctuation voltage of the wide region of direct current or alternating current power supply 30 and is remained in T 0
Any standard electric heating element heater that combines with " thermostat " or thermocouple can be provided at T 0" on-off " control of ambient temperature fluctuations.Yet this type of on-off control need connected temperature T LWith the shutoff temperature T HBetween skew " sluggishness ", thereby cause at T 0Significant on every side temperature fluctuation.On the contrary, self limiting electrical heating elements 20 provides the more stable control with less fluctuating.See Fig. 8, wherein T 0It is 75 ℃.Under the situation of using switch, heater is in all-pass or turn-offs fully.The result is, heater is to target temperature T 0When adjustment is made zero, circulate to zero heat production from high heat production continuously.On the other hand, utilize the present invention, resistance only changes with temperature gradually, thereby makes target temperature T 0The minimized while of fluctuation on every side, only little by little change heat production.
At transition temperature T 0Under, the compositions that is used for switch has low-down resistance, is about 10 ohm or littler.Therefore, on-off switch is a little less than T 0Temperature under connect heater fully.On the other hand, example self limiting electrical heating elements 20 of the present invention is only reduced to about 1000 ohm, thereby under uniform temp, only causes heat production slightly to increase.Be higher than transition temperature, switch can have very high resistance, is about 10 9Ohm or higher.Therefore, switch turn-offs heater fully.By comparison, self limiting electrical heating elements compositions of the present invention only has slightly high resistance under this temperature, thereby thermal output only slightly reduces.In addition; With regard to medical firing equipment; Because equipment possibly fully contact the big radiator of time experience with tissue at certain a moment, and after certain a moment, equipment was not worked the time and only contact and do not meet with any radiator with air, so this temperature fluctuation can aggravate.Therefore thermistor-type heating element heater of the present invention 20 produces following medical firing equipment: it is compared with the prior art medical treatment firing equipment that is controlled by the on-off temperature switch has much constant target temperature, even still like this under the situation of the quick fluctuating of the heat sink action that allows to be associated with the ablation of tissue that cuts.
The resistivity of ptc material and the relation of the flex point between the temperature are further preferred, because it causes self limiting electrical heating elements 20 to have at T 0The less relatively temperature deviation in several years (for example, 3-10 degree centigrade) only on every side.Therefore, if T HAnd T LBe respectively corresponding maximum temperature and the minimum temperature of heater system when carrying out the medical treatment use, the temperature controlling range (T of then one or more self limiting electrical heating elements H-T L) much littler than the temperature controlling range of the medical firing equipment element of switching manipulation.Exemplary heating element heater 20 will provide about 3 ℃ to 5 ℃ temperature-control range usually, and used material is as the critesistor in the medical firing equipment.
Different ablation of tissue or cutting process possibly need different Optimal Temperature opereating specifications.For example, different programs possibly need the cutting probe of difformity and size, thereby changes the radiator requirement, thereby changes the heat production and the temperature range of medical firing equipment.In different programs, melt different target tissues, this possibly need medical firing equipment that every kind of program is had different optimum cutting temperature scopes.Therefore, some ablation of tissue or cutting process possibly need different target temperature T 0And different T HTo T LOpereating specification.These criterions can be adjusted through using careful PTC, NTC or the ZTC heater material of selecting to be used for self limiting electrical heating elements 20 of optimal resistance temperature profile.In addition, can use various alloys and various concentration of dopant to change characteristic, so that produce different resistance temperature curve figure.Can use the further combination of PTC, NTC and ZTC material to produce different resistance temperature curve figure.Many such materials all can be buied in market at present.
Fig. 9 A comprises the resistance temperature relation of NTC material.This layout can be used for creating at operative temperature T 0The operative temperature T that the place has sharp cut-off 0Fig. 9 B comprises the resistance temperature relation of ZTC material.This layout is used in whole temperature range T HTo T LThe middle constant thermal output that forms certain level.Fig. 9 C comprises the resistance temperature relation of NTC/ZTC admixture.This layout can be used for forming T HTo T LWide operating temperature range, it has the constant thermal output that is in certain level, but in temperature T LThe place has sharp cut-off.Fig. 9 D comprises the resistance temperature relation of PTC/ZTC admixture.This layout can be used for forming T HTo T LWide operating temperature range, it has the constant thermal output that is in certain level, but in temperature T LPlace's heat production sharply increases, thereby stops probe temperature to fall to T all the time LUnder.
PTC, NTC and ZTC material can be processed by the crystallization or the semi-crystalline polymer base material that are added with certain conduction " doping " material.With regard to the polymer-matrix critesistor, transition temperature be by the fusing of polymer molecule or solidify cause.With regard to crystallization or semi-crystalline polymer, molecular structure is piled up in solid phase and comparatively closely in liquid phase, is piled up not tightr.Polymer molecule generally is non-conductive, therefore must add conductive dopant so that the material conduction.Be lower than T 0Temperature, the most polymers molecule is in solid phase, thereby piles up closely, thereby is in the state or the level of its tool electric conductivity.Be higher than T 0Temperature, the most polymers molecule is in liquid phase, thereby loose accumulation, thereby is in it and least has the state or a level of electric conductivity.Select transition temperature T for identical matrix polymer 0General polymer softening point with selected matrix polymer is consistent.In Fig. 6, the two is all processed switch and heater by the polymeric material of same type, thereby they have identical transition temperature T 0
Material with these attributes is known, and can on market, buy and have a series of transition temperature T 0Material.Figure 10 illustrates the different transition temperatures of some possible polymeric matrixs that are used for conductive polymer compositions.Therefore; For the conducting polymer that uses polyethylene stearate, polycaprolactone (PCL), ethylene ethyl acrylate (EEA), low density polyethylene (LDPE) (LDPE), high density polyethylene (HDPE) (HDPE), polypropylene (PP), polyvinylidene fluoride (PVF2), polyvinyl fluoride (PVF), ethylene tetrafluoroethylene copolymer (ETFE), ethylene perfluoroalkyl alkoxy copolymer (PFA), tetrafluoroethylene/hexafluoropropylene copolymer matrixes such as (FEP) to process, observed the transition temperature that increases successively.Table 1 shows the crystalline melting point of some kinds of polymer.The spendable conductive polymer compositions of the present invention can comprise these polymer and at U.S. Patent number 4,514, any polymer among those polymer of describing in 620 and 5,554,679, and the complete open of above-mentioned patent is incorporated into this by reference.PTC, NTC and ZTC material can also make through two kinds of fusion or more kinds of conducting polymer.
Table 1
Polymer type Fusing point (C)
Vestenamer " " 8012 (cyclooctane polymer) 40-55
Ionomer 85-99
Ethylene vinyl acetate (EVA) 103-106
Low density polyethylene (LDPE) (LDPE) 105-110
LLDPE (LLDPE) 122-124
Polybutene 126-127 126-127
High molecular weight polyethylene (HWPE) 125-132
Super high molecular weight low density polyethylene (LDPE) (UHMWPE) 125-135
High density polyethylene (HDPE) (HDPE) 130-135
The elastomer amalgam 160-165
Polypropylene (PP) 160-165
Polypropylene block copolymer 160-165
Polyvinylidene fluoride (PVF2) 160-165
Polyamide 12 (PA12) 180
Polyamide 11 (PA11) 185
Polyamide copolymer 160-220
The thermoplastic fluorine-containing elastomer 160-220
Thermoplastic elastomer 185-202
Ethylene-chlorotrifluoro-ethylene copolymer (ECTFE) 190-191
Polyamide 6 10 (PA610) 215
Polytrifluorochloroethylene (PCTFE) 215-216
Polyamide 6 (PA6) 220
Polybutylene terephthalate (PBT) 220-223
Merlon (polyester) 200-260
Gather-4-methylpent-1-alkene 230-240
Polyamide 6-3-T 240
Polyamide 66 (PA66) 255
PET (PET) 250-265
Ethylene-tetrafluoroethylene copolymer (ETFE) 270-271
Perfluoroalkyl alkoxy copolymer (PFA) 250-305
PVF-propylene copolymer (FEP) 290-291
Polytetrafluoroethylene (PTFE) 325-327
Dopant material is added into base material so that its conduction, allow like this this material show similar heating element heater.Also add alloy and perhaps widen curve chart discussed above with the resistance variations that slows down.Alloy is a conductive material, such as white carbon black, metallic oxide, semi-conducting material, its admixture etc., or has electric conductivity and can process short grained other materials.Through type that changes alloy and the ratio resistance temperature relation that concentration obtains PTC, NTC and ZTC material.For example, the switch among Fig. 8 has the alloy with self limiting electrical heating elements same type, but the concentration of the alloy of self limiting electrical heating elements is much smaller and homodisperse.Therefore, the low concentration of conductive particle or density are a kind of modes of resistance variations gradually that obtains the expectation of self limiting heating element in the polymer-based composition and use thereof in packaging.Generally speaking, be higher than 50% doped level formation switching mode material, the doped level of 15-40% forms thermistor material, and 10% doped level forms electromagnetic interference and/or static discharge.Porosity, surface area, particle size and the oxygen content that can also change conductive dopant produce various attributes.Can also add to base material and surpass one type alloy.Substrate molecule or particles of doped material can actually cause Ohmic heating.Therefore, alloy can produce electron transfer or vibration heating or produce this two simultaneously.All of these factors taken together and various carbon black loading level and other factors together cause approaching the combination of unlimited amount between type and the amount and the type of substrate of alloy, thereby produce the ratio resistance temperature relation that approaches unlimited amount.
PTC, NTC and ZTC material can also be processed by ceramic material that is added with conductive dopant or ceramic based material.Ceramic material can be an electric conductivity or dielectric according to phase.Can ceramic material be designed at specified temp T 0The place take place from the solid to liquid or from liquid to solid phase transformation.Usually, ceramic based material is Barium metatitanate. and/or relevant bivalence titanate and zirconates.Typical alloy comprises lead, strontium, rare earth metal, antimony, bismuth etc.Add alloy to increase or to reduce the unconventional scope (anomaly range) of base material, perhaps further regulate the slope of resistivity temperature relation.Various ceramic thermal resistance heaters with different temperature resistivity relation can be buied on market.Ceramic thermal resistance heater material manufacturer can also make great efforts to set about carrying out special exploration project, so that special desired characteristics to be provided.
Usually, based on the requirement of medical procedure, the desired operation temperature range that particularly melts to the particular organization that will carry out is selected concrete self limiting electrical heating elements 20.---no matter being PTC, NTC, ZTC or its combination---produces this temperature range can to select suitable self limiting electrical heating elements material.Notice that the two size, shape and electrical conductivity and other factors of probe and insulant can influence pops one's head in and the operating temperature range of heater.In the calculating of carrying out for the resistance temperature curve figure that produces expectation, considered aspect all influences.Then the best commercially available thermistor material of selecting to have the optimal resistance temperature profile cooperates desired specific medical program.
The physical form of suitable self limiting electrical heating elements 20 can comprise the one or more PTC/NTC/ZTC rings of material around the core electricity partition 70 or enclose 22 or be made up of it.See Fig. 2 A.Core electricity partition 70 keeps a pair of circuit connecting wire 40 at interval, to prevent electrical short.The single circle 22 of heating element heater 20 can be connected in parallel to cable circuit connecting line 40, so that one group of current path through circle 22 to be provided.Perhaps, two end turn 22 of heating element heater 20 can be connected to cable 40, to produce along the current path of the whole length of heater 20.
Shown in Fig. 2 B, core electricity partition 70 has the cross section of band groove or raceway groove, and this groove or raceway groove hold longitudinal passage and one or more heat conduction probe 60 of cable 40, perhaps possibly also hold pick off (being not shown on this).Particularly, core electricity partition 70 can have one group of vertical recess 73, this organize vertical recess 73 have with its in the shape of corresponding cable 40, probe 60 or the sensor cluster close match of being taken in.
Self limiting electrical heating elements 20 perhaps can be formed (Fig. 3 A and Fig. 3 B) by being wrapped in core electricity partition 70 PTC/NTC/ZTC material 24 thin layer, sheet form on every side.Connect with mode that the co-current path is provided on whole thin slice 24 length thin slice 24 cable electrodes 40 along the line.Another kind of possible layout can be only to let a cable 40 at far-end contact thin slice 24, and lets another cable 40 at this thin slice of near-end contact.
Another alternate ways can be to adopt the core electricity partition of being processed by self limiting conduction PTC/NTC/ZTC material 70.Because the whole length of cable 40 extend past core partitions 70, thus electric current with parallel flow through the main body of separator material with heat production.Sold as antifreeze in storage tank heat device, ground heater, the pipe or be used for the multiple commercially available self regulating and control formula heater cable that domestic hot water temperature keeps and have such structure; Such as by Tyco Thermal Controls, those cables that LLC makes with its Raychem brand.In such structure, the probe 60 need for example have the electric insulation coating and with conductive spacer material 70 electric insulations.
In the embodiment of Fig. 2 A/ Fig. 2 B and Fig. 3 A/ Fig. 3 B, except that core electricity partition 70, can there be another the electric partition that is called as gasket ring electricity partition 75.Gasket ring partition 75 is an electrical insulator in some zones, and in other zones, is heat conduction.Not expecting to have between all parts of electric conductivity and need electrically insulating material at self limiting heater 20 and circuit connecting wire 40.Heater is connected in series can be different from heater and is connected in parallel.For example, in Fig. 3 A, can exist along the longitudinal joint of gasket ring partition 75 total lengths so that provide parallel circle discussed above to connect.(for example, near the probe place) is heat conductivity in other zones also possibly to need gasket ring electricity partition 75, so that heat can freely be passed to probe 60 from heater 20 between gasket ring partition 75.
Insulating jacket 50 (Fig. 2 A/ Fig. 2 B and Fig. 3 A/ Fig. 3 B) can provide at least a portion of the outer surface of hands spare or handle.The isolated heat that produced by heating element heater 20 of chuck 50, thus heat is remained in the equipment and not heated handle is provided so that let user easily control tissue ablation device.Though do not draw in the drawings, from the beginning chuck 50 extends to tail usually, to cover core electricity partition 70.In Figure 1A, insulating jacket 50 has the external shape that is similar to pen.Believe that this shape can provide Equipment Control and sensation superior as scalpel formula equipment.Figure 1B illustrates the chuck 50 with thicker handle, and this handle is the spitting image of the handle of screwdriver.Any external form that chuck 50 can take user to expect most.
Insulating jacket 50 can cover all electronic circuits in the hands spare usually.Chuck 50 is preferably by having about log 10 10Ohm-cm or more the high-resistance material of high resistivity process so that hold by the formed electric field of circuit.Therefore, armarium 10 preferably will can not produce any electromagnetic interference or static discharge.
Heat conduction probe 60 (Fig. 2 A/ Fig. 2 B and Fig. 3 A/ Fig. 3 B) stretch out from insulating jacket 50, and are thermally coupled to self limiting electrical heating elements 20.The Any shape that probe 60 can have in the some kinds of shapes; Comprise that circular cross section 62, square cross section 64, ellipse, rectangle or other oblong cross sections, round as a ball most advanced and sophisticated 66 perhaps also can be the probes with spin tip, blunt tip, sharp-pointed or other puncture tip as 68; And even can form hollow pipe, this hollow pipe is fit to the fluid of supply equipment heating so that be applied on the target tissue or be injected in the target tissue.Probe also can have a more than probe or a plurality of prongeds are arranged as forked probe.Likewise; Cutting, stitching or stitching ability can followed or have to probe; And if thereby its be the receiving heat and conduct heat of heat conductivity with the heating element of slave unit; Then can form some kinds and knownly handle any in the medical instrument, such as those medical instruments that in the arthroscopic surgery operation, use.For example, probe tip can comprise and is used for delivering the biodegradable nail of preheating or the instrument of other materials to target tissue.Can be used for burning blood vessel or melt nerve or its hetero-organization through preheated material through what this kind tool was delivered.
Probe 60 can be the part with interchangeable modules of probe bracket 61 (Fig. 4), and this probe bracket 61 utilizes pin, screw, ratchet, spring ratchet, magnet, adapter or other attachment arrangements and is attached to self limiting electrical heating elements 20, insulating jacket 50 or electric partition 70.Fig. 4 has described to be attached to the pin 63 of core 70.Under any circumstance, probe bracket 61 removably is connected to medical firing equipment, wherein, and the also adaptive same support 61 of multiple probe type.Support 61 has on the rapid card and the ability of throwing off different probes, so that carry out medical procedure more effectively.The interchangeability of probe provides much bigger motility in the use of specific firing equipment.If heating requirements is similar, then can only use identical instrument to carry out different medical use through changing a probe module into another probe module.
Probe 60 can comprise or support at least one pick off 66; This pick off 66 can be with respect to probe 60 localized image devices; Such as the imaging fiber device, and can be through the plug assembly definite object position that is coupled to suitable display so that auxiliary user will be popped one's head in.Any this type of imaging sensor or visor all can be equipped with anti-smog device or antifoggant.Heat from self limiting electrical heating elements 20 can be used with this type of anti-smog device or antifoggant collocation.Pick off 66 can also be neural detector.This type of neural detector is known, and in other probe shape medical instruments, obtains using.They and imager are similar, also can be positioned at suitably near the probe 60, perhaps even among can being integrated into heated probe self are used for more refined control is carried out in the location.
Cable circuit connect 40 between self limiting electrical heating elements 20 and power supply 30 the establishment circuit be connected.Electric can be 11VAC, AC battery, DC battery, solaode, or self is by the customization power module of any aforementioned energy supply.Example power supply 30 (Figure 1A) generally includes in order to transmit the RF of other power to equipment 10 and to form the circuit from the reception signal of pick off 66.Power supply 30 is connected with removable plug 45 by cable 40.With regard to Fig. 1 C, power supply is connected with cable circuit and is completely contained in the insulating jacket 50.Therefore, medical firing equipment 10 has " wireless mode " (that is, not the having outside Wiring connector) as being described among Fig. 1 C.
Medical treatment firing equipment 10 can also comprise on/off switch 80, and this on/off switch 80 can be positioned on the insulating jacket 50, in equipment work near the hands (Figure 1A-Fig. 1 C) of user.The on/off switch connection is connected 40 with the circuit that turn-offs from power supply 30, thereby cuts off the power supply to self limiting heater 20.
Medical treatment firing equipment 10 can together use with other armarium, and said other armarium are such as ultrasonic equipment, monopolar electrosurgical surgical apparatus, bipolar electrosurgical surgical apparatus, attraction equipment, bloating plant are arranged, being blown into equipment, microelectronic chip equipment, fiber plant, radio-frequency apparatus, microwave equipment, infrared equipment, X-ray equipment, laser equipment, light emitting diode device, resistance or wire-heated equipment, or can being installed on the probe 60 or being installed near other standard medical equipment the probe 60.Electrosurgery be to biological tissue apply high frequency electric as in order to tissue is cut, solidifies, the dry or means of fulgerizing.In the electrosurgery program, tissue is by heating through its electric current wherein.Its benefit comprises can carry out clean cut and lose blood limited.Electrosurgery equipment is usually used in the surgical procedures, to help prevent losing blood in the hospital operating room or in the outpatient operation.
Can be through making probe 60 far-end (for example, pick off 66) no matter touch target tissue---be on patient's skin surface, subcutaneous or depths more---use the medical firing equipment 10 that makes up according to the present invention.If target tissue is a skin, then can the holding temperature of equipment be elected as and be no more than 45 ℃ (113 ° of F).Under such moderate temperature, from the heat transfer of the skin of popping one's head in can produce skin-tightening, skin surface is reinvented and collagen reconstruct, is used for corium to regenerate and cosmetic applications.This machinery that can also be accompanied by the skin surface cell melts.Perhaps, can use higher temperature to cut skin, meanwhile burn any hemorrhage.
If target tissue is a subcutaneus adipose tissue, then can come the selectivity injury to be close in the terminal adipose cell of probe through the heat transfer of inserting the ultrasound guided probe in the skin.If target tissue is a nervous tissue; Then can use from the heat transfer of probe and melt selected nerve; The rami temporales branch of innerv nervus facialis or angle neural (angular nerve) is provided such as nervi trigeminus (for example, being used for migraine treatment), to the corrugator supercilii of face and procerus.This can help to remove wrinkles on one's forehead.
Target tissue can be a glandular tissue, as in the sweat gland of skin, with the treatment hyperhidrosis, perhaps cuts entirely in art or the tonsillotomy carrying out tonsil, and target tissue is the tonsil in the oral cavity.
Target tissue can be vascular tissue's (vein, tremulous pulse, blood capillary, blood), wherein can produce local blood to vascular tissue through the heat transfer of probe and solidify and burn.Perhaps, under the temperature of milder (nearly 37 ℃ of body temperature), the hollow probe can inject the preheating fluid in target artery or vein, for example be used for topical.
Target tissue can be some misgrowth, polyp or tumor, such as among hole or oral cavity.At this, can melt this tissue through the heat transfer of probe.Example comprises: be shown in the mucosa injury in the Ba Leiteshi esophagitis (Barrett ' s esophagitis), perhaps come from the tissue growth of nasal conchae hypertrophy, the perhaps removing of polyp of colon or rectal polyp.
Through applying heat for example to melt sensory nerve or to stimulate the blood flow in the muscle of aching to selected nerve or muscular tissue, can also be through the armarium of heating as the part of pain control or therapeutic scheme.
Utilization can substitute the equipment based on electric arc that is used for similar applications at present according to the armarium that self limiting electrical heater element of the present invention makes up.Any requirement all can be adopted the present invention to the medical use that selected target tissue carries out controlled heat transmission, and has very high control and safety.The present invention can be used for medical treatment, dentistry and veterinary's operation.
The present preferable material that is used for the self limiting electric heater is the combination of one or more NTC materials and one or more ZTC materials, and it has and is similar to the resistance-temperature response curve shown in Fig. 9 C.Suitable material comprises from Cantherm, Montreal, and critesistor 3, MF51, MF52 and the CWF of Canada, and various from General Electric, Fairfield, Connecticut, the material of USA.
With reference to Figure 11-Figure 18, power supply 97 generates electric field in one group of at least two conductive segments (conductive segments) between 225.Power supply 97 can directly generate electric field between conductive segments 225, perhaps, can be field generator 100 energy supplies indirectly, and field generator 100 transfers between conductive segments 225, to generate electric field.Power supply 97 can be dc source or alternating current power supply.Under the situation of dc source 97, can require field generator 100 in target tissue 250, to produce alternating current or alternating polarity electric field.Example power supply 97 is dc-batteries, and this is because there are many standard-sized these type of batteries, their compact size but can be for can forming the particular electrical field generator device energy supply of suitable electric field, thus cause the accurate cell injury of expectation.
It is preferred that alternating current is compared with unidirectional current, and this is because alternating current can produce than the more heat of unidirectional current for every ampere in this case.It seems to have specific resonant frequency or peak frequency, obtain maximization by the heat production that alternating current caused of passing particular type target tissue 250 at this frequency place.In this frequency, electric current passes target tissue 250 with the resistance of minimum.Therefore, at the particular resonant frequency place of particular target cell, in this cell, produce identical or more heat needs less power.Therefore, alternating current is preferred, thereby because its power requirement and permission equipment that has reduced equipment is small enough to hand.The resonant frequency of neurocyte and surrounding tissue thereof is 460KHz and thereby is preferred frequency.Electrosurgery equipment is usually in this frequencies operations, and this is because this frequency resonant frequency of the tissue of many types seemingly, but not only is the resonant frequency of nervous tissue.
Field generator 100 comprises pulse width modulated power supply, and this pulse width modulated power supply is electrically connected to the common circuit board component that comprises resistor, capacitor, diode and switch.Field generator 100 can also comprise transformator 175 (Figure 12), and wherein the output signal from said pulse width modulated power supply is to be connected with the elementary of said transformator.Usually custom design field generator 100 has the specific alternating polarity field of CF and power with generation, so that according to the requirement of the specific accurate cell injury of expectation of generation and with the particular probe/extension 200 of equipment 91 function of bringing into normal play.Example field generator 100 uses three pins probe 200 to produce the output that is suitable for neurocyte, and wherein generator also is designed to very little size.Field generator 100 comprises pulse width modulated power supply and the circuit board assemblies that is assembled on the custom circuit plate; Said custom circuit plate has long and narrow generally shape; Such as rectangle, it can be put in the shell of the shape and size of describing like Figure 14-Figure 16 with typical pen.Perhaps, field generator 100 can comprise many circuit boards, and these circuit boards are electrically connected by loose cable so that put in the various difform shells.Field generator 100 comprises toroidal transformer 175, and this toroidal transformer 175 is electrically connected to the far-end of said custom circuit plate, and this far-end is in the annular hole of transformator 175, passes target tissue 250 from the secondary voltage and the electric current of transformator 175 at this.
The pattern pulse width modulated power supply comprises at least 6 electrical connections: connect 101 by cathode power supply and is connected 103 2 power supplys forming with negative power supply and imports connection; 2 signal outputs connect 105 and 107; And two fine setting inputs connect 109 and 111.Output signal 105 and 107 is created the electric field of the rapid alternation of polarity in the target tissue between conductive segments 225, so that in target tissue, generate or the alternating current of inducting.Electric current is able to generate or inducts because tissue contains water and thereby the permission of other electroconductive molecules produces electric current in response to electric field.Output signal 105 and 107 obtained electric treatment through said custom circuit plate before being electrically connected with conductive segments 225.The frequency of the alternating polarity of electric field is matched with the frequency of the alternating current of creating thus to a great extent.Perhaps, the elementary input that output 105 and 107 can be electrically connected on the transformator 175, wherein the secondary output of transformator 175 is 105a and 107a.Transformator 175 can be used for helping the structural resonant frequency of stable target, and filtering is from the switching noise of generator 100, and through than the 460KHz resonance of nervous tissue operation generator 100 and the battery life of prolongation equipment 91 under the frequency more efficiently.In addition, like following discussion, can with from 105, the signal through electric treatment of 105a, 107,107a is transmitted back to control unit 125, the input 109 and 111 on the field generator 100 is further handled and be returned to signal at this.
Field generator 100 preferably can send one or more DC pulses from one or more signal outputs 105 or 107 to target tissue 250, so that detect the exact position that target is neural and the high-frequency ac armarium was provided before heat production.Orthopaedic surgical operations doctor transmits before the AC field of heating target tissue 250, and the surgeon can use one or more DC pulses to come accurately location target neurocyte or its ingredient.DC pulse can be various amplitudes and waveform, and alternatively, can send the pulse of multiple shape simultaneously from field generator 100.Through will at least two conductive segments be positioned on the zone of target cell or navigate in the zone of target cell, the neural muscle that is driven of one or more impulse stimulations that sends from conductive segments, thus cause said muscle twitches or move with certain mode.Therefore, through mobile probe 200 and conductive segments 225, can before transmission removal target nerve carries out neural treatment electric current, this nerve be located.Search for, until witnessing in muscle twitches or correct the moving, the surgeon knows and has located correct neurocyte or its ingredient when the time comes, and at least two conductive segments accurately are positioned at accurately on the target tissue 250 at present.Know at least two conductive segments through the exact position of detecting and the affirmation high-frequency alternating current transmits and be properly oriented, can locate high-frequency ac armarium 91 very accurately, so that realize melting nervous tissue.At this moment, the surgeon can start AC field then so that target tissue is accurately heated, and any other tissue is not heated.
Field generator 100 is preferably small but excellent little, so that it can easily be hold by one hand by common adult.For example, can use standard 9V battery to come to be 100 energy supplies of example field generator, so that realize the cell injury of expectation.
Alternatively, high-frequency ac armarium 91 can have two probes or pin type protuberance 200, and can be monophasic by the electric field that generator 100 is generated.In Figure 11, described the block diagram of this pattern.Probe or pin type protuberance 200 can comprise with field generator 100 on a conductive segments 225 being electrically connected of contact 107, and another probe or pin type protuberance 200 can comprise with field generator 100 on another segmentation 225 of being electrically connected of contact 105.Perhaps, high-frequency ac armarium 91 can have a probe or pin type protuberance 200, and can be monophasic by 100 electric fields that generated.In Figure 11 A, described the block diagram of this operator scheme.Single probe or pin type protuberance 200 can comprise whole two segmentations 225.In other embodiments; Equipment 91 can have more protuberance 200; And therefore field generator 100 need have equal number at least signal output to utilize this many protuberances, said signal output is electrically connected to a probe or pin type protuberance 200 separately.For example; Each protuberance can send a signal in a signal or the many common signals in the many phase signals that produced by generator; Wherein equipment 91 can have many probes or pin type protuberance 200; So that create complicated electric field combination, thereby help to produce the accurate cell injury of very specific expectation.Perhaps, equipment 91 can have many probes or pin type protuberance 200, and two signals output 105 and 107 is only arranged, and wherein 105 and 107 signals in an alternating manner the row or the arc of protuberance 200---perhaps along---is connected to this many protuberances.Come to replace only two signals by this way, can only create the macrolesion district through the blow-up changed electric field along said row or arc, this is because between each protuberance 200, created electric current by this way.
Exemplary high-frequency ac armarium 10 has three pin type protuberances arranging in upright arrangement.See Figure 15 and Figure 16.The protuberance 200 of central authorities is electrically connected to field generator 100 through common signal lead-in wire 107a.Parallel connection is electrically connected to field generator 100 to the protuberance in two outsides through single-phase signal lead 105a.In Figure 12, described the block diagram of the equipment of Figure 15 and Figure 16.In all layouts and pattern, phase signal passed self limiting conductive material electricity assembly 150 before getting into target tissue.
At least one probe or pin type protuberance 200 can be attached to the circuit of high-frequency ac armarium 91 and other parts of structure removedly.In addition, (Figure 14-Figure 16), it is attached to the remainder of high-frequency ac armarium removedly can to have at least one removable attached pin type protuberance 98,200 of far-ranging, many dissimilar, sizes, shape, material etc.Therefore; The present invention includes a series of removable attached tips 98; Wherein each tip 98 comprises: at least one probe of protuberance 200 and position at least two conductive segments 225 on it; Be electrically connected to the remainder of equipment when wherein, they are on being attached to armarium separately according to the circuit diagram among Figure 11-Figure 12.Probe is adaptive to be used to be penetrated under patient's the skin surface, with neural or other target structures under approaching and/or the contacting skin, thereby and to this class formation transmission heat, RF or other energy.
A kind of so removable attached most advanced and sophisticated 98 ' can be another neural finder, on its far-end, has two little conductive electrodes or liner 99.Two little liners are used to make the surface electrical of target tissue to touch field generator 100.Therefore, can at first use " neural finder " most advanced and sophisticated 98 ' to seek nerve, then in case the location just is attached to equipment 91 so that nerve is heated with independent treatment most advanced and sophisticated 98.
Removable attached most advanced and sophisticated 98 are substantially taper or cup-shaped usually; On the wide end of cone, has opening; And on the narrow end of cone is smooth, so that form on the whole cup-shaped, wherein at least one pin type protuberance 200 is attached to the outer surface at the narrow end of cone or the cup end.The far-end that has removed the high-frequency ac armarium 91 at tip 98 also can have taper or cup-shaped substantially, and wherein the equipment vertebral body is slightly less than most advanced and sophisticated cone.Therefore, most advanced and sophisticated 98 concave cone part can slide on the convex cone part of equipment vertebral body then, wherein most advanced and sophisticated 98 is installed to closely on the equipment vertebral body.In addition, can there be retention mechanism alternatively, such as the clasp device, press buckle device, locking device or similar fasteners,, thereby makes the surgeon can carry out surgical operation so that tip 98 is remained on the equipment vertebral body with very firm mode.Said retention mechanism also will have releasing device, thereby can remove removable attached most advanced and sophisticated 98.Therefore, the clasp device, can discharge said device to remove most advanced and sophisticated 98 by buckle device, locking device etc.To be example by buckle device, most advanced and sophisticated cone can have flexible character, causes the distortion of most advanced and sophisticated cone to allow the finger extruding, thereby discharges the one or more snap fastener points between most advanced and sophisticated cone and the equipment cone.When most advanced and sophisticated 98 when snap fastener puts in place on equipment 91, at least two conductive segments 225 and generator signal 105 or 105a and 107 or 107a between be electrically connected.Can under aseptic condition, supply removable attached most advanced and sophisticatedly 98, and after use, it abandoned then.
Use the fine setting input to connect 109 or 111 by field generator 100 (Figure 12) and provide about 5% with interior pulse-width modulation operation frequency.The fine setting input connects 109 and 111 and is electrically connected to control module 125, and this control module 125 is by battery 97 energy supplies and be electrically connected to field generator 100.Control module 125 comprises one or more trimmer resistors or the electronic building brick with similar functions; They are electrically connected to frequency modulation(PFM) gauge tap 127; This gauge tap 127 is the setting switches on the control unit 125, be used for manual adjustments signal 105 frequency.
Control module 125 also can be arranged to through signal 105 being sampled and it being carried out electric treatment to confirm whether frequency is the best, comes automatically to regulate and stablizes the frequency by 100 signals that generated.Signal from 105 and electric current are filtered, handle and analyze by electricity, produce in order to regulate the signal input of fine setting input 109 or 111.Therefore, the feedback circuits of control module 125 formation from signal output 105 to fine setting input 109, this causes the automatic fine tuning of output and stable.Under the situation of a more than output phase signal, possibly need to create feedback circuit, so that the frequency of all phase places is automatically adjusted and stablizes to each output phase.Control unit 125 also confirms whether be higher than certain maximum preset limit through the electric current of target tissue alternatively, and when said electric current exceeds this limit, closes its electric field generation.This is that current cut-off is provided with 129, and wherein surgeon or technician can be provided with maximum current level, and equipment 10 is closed its electric field and generated when being higher than this level.
Use at least two electricity outputs---phase signal 105 and common signal 107---to carry out surgical operation.Output can be filtered through the preferred circuit board component, conversion and otherwise by electric treatment, to produce the accurate cell injury of expectation.Phase signal 105 arrives at target tissue 250 through self limiting conductive material electricity assembly 150.It passes target tissue 250 then, and turns back to field generator 100 through common signal 107.
150 regulation and control of self limiting conductive material electricity assembly are through the electric current of target tissue 250.Such as preceding text about first embodiment description, self limiting conductive material electricity assembly 150 has on electricity and is similar to critesistor, the thermoelectric occasionally function of switch.
At self limiting conductive material electricity assembly 150 is under the preferable case of switch; 150 close one of short duration period fully with the alternating current in the target tissue fully cools off until target tissue; Thereby avoid unnecessary cell damage, switch 150 can be connected alternating current once more in target tissue then, thereby once more to its one of short duration period of heating; Only be heated to once more and turn-off, repeat this process.This process per second basically repeats many times, thereby in target tissue, produces the temperature of steady statue generally.
Self limiting conductive material electricity assembly 150 show under the situation of similar critesistor or thermocouple; 150 variations in temperature does not cause disconnected suddenly/logical switching of alternating current in the target tissue; Increase or reduce but produce the heat gradually that is described below, so that control target tissue and temperature of tissue surrounding.Critesistor has the mildest alternating current fluctuation.
Self limiting conductive material electricity assembly 150 is made up of the even admixture of the different materials that comprises base material and conductor alloy basically.Self limiting conductive material electricity assembly 150 has the specific combination of substrate and alloy, and this combination allows the resistance of self limiting conductive material electricity assembly to become with its temperature.When electric current during through self limiting conductive material electricity assembly 150, pass target tissue 250 and the result of the electronics that in self limiting conductive material electricity assembly 150, takes place, ion or the collision of other charged particles that cause as alternating current, in 150, produce hot.Therefore, the electric current of the increase of process target tissue 250 produces the heat production that increases in self limiting conductive material electricity assembly 150.This heat causes the structural change in the molecule of even admixture of material, and this then cause the variation of the electrical conductivity of self limiting conductive material electricity assembly.With some self limiting conductive material or critesistor is example, and thermal conductance causes base material and expands, and this is separated the conductive dopant that is suspended in wherein, thereby reduces and finally cut off the electric current through wherein.In other self limiting conductive materials or critesistor, variations in temperature causes the phase transformation of base material or dopant material, and this causes the structural change of molecular level, thereby produces from electric conductivity to dielectric transition effects, and perhaps vice versa.
In any case; Must note very especially selecting/the self limiting conductive material of designing optimal electricity assembly 150,, thereby produce best surgical operation performance so that produce mathematical characteristic best between temperature and the resistance; That is, cause the required temperature range of accurate cell injury of expectation.The temperature and the relation between the electrical conductivity of self limiting conductive material electricity assembly are normally nonlinear, so we use logarithmic scale to describe the critesistor attribute.Electrical conductivity is measured with the inverse of resistivity usually.
In a preferred embodiment, self limiting conductive material electricity assembly 150 is processed by ptc material.Fig. 7 is the resistivity-temperature profile that is suitable for the ptc heater material of the object of the invention.Fitness to typical operation requires resistivity to increase gradually with temperature, shown in the middle part positive slope characteristic of curve chart.In addition, T in curve chart 0There is flex point in the place.When temperature rises to T 0On the time, resistivity increases with decrescence speed with temperature.Therefore, along with temperature rises to T 0On, the electric current that passes target tissue exists decrescence that the gentleness of speed reduces.When temperature is reduced to T 0Under the time, resistivity reduces with decrescence speed with temperature.Therefore, along with temperature is reduced to T 0Under, there is the decrescence gentleness increase of speed in the electric current that passes target tissue.With reference to Fig. 7, from T 0To T H, resistivity increases gradually, thereby reduces the heat production in the target tissue.Likewise, from T 0To T L, resistivity reduces gradually, thereby increases the heat production in the target tissue.At T 0There is temperature spot stable on the mathematics in the place, and it also is called flex point.Material with this flex point relation is preferred, so that be provided at T 0The self limiting conductive material electricity assembly of the stability that the place is optimum, thus stable AC in the target area, produced.
The temperature of self limiting conductive material electricity assembly 150 has determined the electric current through the target area.Therefore; The key Design criterion of high-frequency ac armarium 91 is need to confirm which type of minimum current to produce the accurate cell injury of expectation; Be that which type of self limiting conductive material electricity assembly provides this magnitude of current at its mathematics balance place then, thereby confirm best self limiting conductive material electricity assembly to the application of high-frequency ac armarium.
Different accurate cell injury programs possibly require different cells heating or current practice scope.For example, the probe that different programs possibly need pin type protuberance 200 to have difformity and size, thus change current requirements, thereby change the self limiting conductive material electricity assembly requirement of high-frequency ac armarium 91.Different target tissues possibly require different electric currents or heating to carry out this operation.Therefore, some program possibly require to have the different target temperature T 0And has a different operating scope T HTo T LDifferent self limiting conductive materials electricity assemblies.These criterions can be through carefully selecting PTC, NTC or ZTC thermistor materials adjusted for high-frequency ac armarium 91.In addition, can use various alloys and various concentration of dopant to change characteristic, to produce different resistance temperature curve figure.Can use the further combination of PTC, NTC and ZTC material to produce different resistance temperature curve figure.
Fig. 9 A comprises the resistance temperature relation of NTC material.This layout can be used for producing as by temperature T 0Determined maximum operating current, the electric current on this has sharp cut-off.Fig. 9 B comprises the resistance temperature relation of ZTC material.This layout is used in the inherent whole temperature range T in whole target area HTo T LProduce the constant current of certain level.Fig. 9 C comprises the resistance temperature relation of NTC/ZTC material.This layout can be used for producing and T HTo T LThe relevant wide operating current scope of scope, have the constant current that is in certain level, but in temperature T LThe place has sharp cut-off.Fig. 9 D comprises the resistance temperature relation of PTC/ZTC material.This layout can be used for producing and T HTo T LThe relevant wide operating current scope of scope, have the constant current that is in certain level, but in temperature T LPlace's electric current sharply increases, thereby stops target tissue to fall to certain temperature.
PTC, NTC and ZTC material can be processed by the crystallization or the semi-crystalline polymer base material that are added with some conduction " doping " material.With regard to the polymer-matrix critesistor, transition temperature comes from the fusing of polymer molecule or solidifies.With regard to crystallization or semi-crystalline polymer, molecular structure is piled up comparatively tight in solid phase, and in amorphous phase or elasticity bulk phase, piles up not tightr.Polymer molecule generally is non-conductive, therefore must add conductive dopant so that the material conduction.At T 0Under temperature, the most polymers molecule is in solid phase, piles up closely, therefore is in the state or the level of its tool electric conductivity.At T 0On temperature, therefore the most polymers molecule is in amorphous phase or elasticity bulk phase, piles up loosely, is in it and least has the state or a level of electric conductivity.For the identical selection of matrix polymer, transition temperature T 0General polymer softening point with selected matrix polymer is consistent.
Dopant material is added into base material so that its conduction, and this allow this material show similar heating element heater.Also add alloy and perhaps widen curve chart discussed above with the resistance variations that slows down.Alloy is a conductive material, such as white carbon black, metallic oxide, semi-conducting material, its admixture etc., or has electric conductivity and can process short grained other materials.Through type that changes alloy and the ratio resistance temperature relation that concentration draws PTC, NTC and ZTC material.Therefore, the low concentration of conductive particle or density are a kind of modes of resistance variations gradually that obtains the self limiting heating element of expectation in the polymer-based composition and use thereof in packaging.Generally speaking, be higher than 50% doped level and produce the switching mode material, the doped level of 15-40% produces thermistor material, and 10% doped level produces electromagnetic interference and/or static discharge.Porosity, surface area, particle size and the oxygen content that can also change conductive dopant produce various attributes.Can also add more than one type alloy to base material.Substrate molecule or particles of doped material can actually cause the heating in the critesistor.Therefore, alloy can produce electron transfer or vibration heating or produce this two simultaneously.All of these factors taken together and various carbon black loading level and other factors together cause approaching endless combination between type and the amount and the type of substrate of alloy, thereby produce endless ratio resistance temperature relation that approaches.
PTC, NTC and ZTC material can also be processed by ceramic material that is added with conductive dopant or ceramic based material.Ceramic material can be electric conductivity or dielectric according to phase or structure.Can ceramic material be designed at specified temp T 0The place take place from the solid to the elastomer or from elastomer to solid phase transformation.Usually, ceramic based material is Barium metatitanate. and/or relevant bivalence titanate and zirconates.Typical alloy comprises lead, strontium, rare earth metal, antimony, bismuth etc.Add alloy to increase or to reduce the unconventional scope (anomaly range) of base material, perhaps further regulate the slope of resistivity temperature relation.Various ceramic thermal resistance heaters with different temperature resistivity relation can be buied on market.Ceramic thermal resistance heater material manufacturer can also make great efforts to set about carrying out special exploration project, so that special desired characteristic to be provided.
In some patterns; Add traditional switch to one or more heater circuits of organizing; Perhaps traditional thermocouple is placed near the conductive segments 225; Perhaps carry out this two simultaneously, so that in electric field generate pattern or surgical operation pattern, further strengthen the temperature control of target tissue 250 or the safe current that adds extra level by control etc.
High-frequency ac armarium 91 (Figure 13) generally includes user interface 92, and this user interface 92 comprises main power source on/off switch 93, electric field on/off switch 94, main power source display lamp 95 and electric field display lamp 96.User interface 92 is electrically connected to control module 125 (Figure 12), thereby from its transmission with receive signal, and be electrically connected and indirectly by battery 97 energy supplies through control module 125.Main power switch 93 is engaged to electric power the field generator input and is engaged to control module 125.When switch 93 was connected, power supply indicator 95 was lighted.When generating electric field, can carry out surgical operation, this is controlled by electric field on/off switch 94.When switch 94 was activated, electric field engaged between at least one probe or pin type protuberance 200.Electric field display lamp 96 is lighted when electric field on/off switch 94 engages.
As stated, high-frequency ac armarium 91 hand-held battery power supply stand-alone device preferably.In order to assist in this, all component all is assembled on the little circuit board.In this configuration, switch 93 and 94 can be positioned at the outside of high-frequency ac armarium 91, and is in the position that the next-door neighbour is gripping the surgical forefinger of high-frequency ac armarium 91.Lamp 95 and lamp 96 also can be positioned at the outside of high-frequency ac armarium 91.Frequency modulation(PFM) is provided with 111 and by the inside that (Figure 12) can be positioned at equipment 91 is set, and this is because they are provided with to specific operation usually differently, and need not to regulate during operation.
In order to form for surgeon's the most comfortable and the most rational apparatus, the shape of high-frequency ac armarium 91 is preferably as pen.The meticulous character that produces the accurate cell injury of expectation requires to be similar to the meticulous hand of writing with very little font and moves.Therefore, also can cosily use high-frequency ac armarium 91 to produce the accurate cell injury of expectation to writing the surgeon who feels comfortable with pen.
At least one probe or pin type protuberance 200 have external diameter and 5 millimeters and the above length of 0.5 to 0.7 millimeter of diameter usually, and have the tissue penetration far-end.The surface of at least one probe or pin type protuberance 200 is non-conductive surfaces, therefore except the particular fragments 225 of probe or pin type protuberance 200, not sending electric field.Only just can send electric field from it at segmentation 225 places.
As previously mentioned, need at least two conductive segments 225 in target tissue, to generate electric current.In two embodiments of high-frequency ac armarium 91, at least two conductive segments 225 all are positioned on a probe or the pin type protuberance 200, perhaps on each in two pin type protuberances 200 segmentation 225 are arranged all.Conductive segments 225 can have coating or the coating that segmentation of making 225 has electric conductivity, perhaps can not have coating or coating.For example, probe can be processed by non-conducting material, wherein forms conductive segments by the one or more conductive coatings on it.Probe can be processed by conductive material, except that conductive segments 225, has non-conductive coating everywhere in its surface.Can use any assembling of conductive material and non-conducting material to produce probe/probe with effective conductive segments 225.Segmentation 225 is electrically connected to signal 105 or 107.When segmentation 225 is positioned on the probe or the far-end of pin type protuberance 200, only under the surface of tissue, produces heat, thereby under the situation that does not change tissue surface simultaneously, cause the accurate cell injury expected more easily.Segmentation 225 preferably is positioned at the far-end of pin type protuberance 200, and length is about 1-4 millimeter.
Use the method for said high-frequency ac armarium 91 to comprise: to pick up said high-frequency ac armarium 91; Open said high-frequency ac armarium; Make said at least one probe or pin type protuberance 200 touch the surface of target tissue 250; Said at least one probe or pin type protuberance 200 are inserted under the surface of target tissue 250, perhaps said at least one probe or pin type protuberance 200 are inserted in the body cavity 250; Thereby for said field generator 100 energy supplies are inducted in target tissue 250 or are generated alternating current; Break off field generator 100; Remove said at least one probe or pin type protuberance 200 from said target tissue 250; And repeat the specific accurate cell injury of aforesaid step where necessary to cause expecting.Alternatively, before transmitting alternating current, can use low-power dc electric current to locate interested nerve.
---no matter being the skin surface the patient, subcutaneous or depths more---used the high-frequency ac armarium that makes up according to the present invention can to touch target tissue 250 through making at least one probe or pin type protuberance 200.If target tissue is skin or subcutaneous tissue, then can select the probe of particular type and temperature to realize that reinvent on skin-tightening, surface or collagen reconstruct.Can the holding temperature of equipment be elected as and be not more than 41 ℃ (106 ° of F).Under such moderate temperature, 200 can produce skin-tightening, skin surface is reinvented and collagen reconstruct, is used for corium to regenerate and cosmetic applications.This machinery that can also be accompanied by the skin surface cell melts.Perhaps, can use higher temperature to cut skin, meanwhile burn any hemorrhage.
If target tissue is a subcutaneus adipose tissue, then at least one probe 200 must have percutaneous and is inserted into the tissue penetration structure in the skin, so that the adipose cell near 200 end is caused optionally injury.
Target tissue can be any tissue of before setting forth about first embodiment.Second embodiment is particularly suitable for nerve is positioned and handles.
Target tissue can be intravital any tract, such as the heart, lung, brain, eye, kidney, liver, ovary, thyroid, bladder, uterus, stomach, intestinal, vermiform appendix, gallbladder etc.

Claims (24)

1. medical firing equipment comprises:
Hand-held housing;
Power supply in the said shell;
From the heat conduction probe that the end of said shell extends out, said probe has tissue and contacts far-end; And
Temperature varying coefficient (TTC) element, it forms microheater, and this microheater has the resistance variations of scope from 2 one magnitude to 4 one magnitude in response to scope from 20 ℃ to about 80 ℃ variations in temperature;
Wherein said heat conduction probe is coupled to said TCC element, so that heat is conducted to said tissue contact far-end from said TCC element.
2. medical firing equipment according to claim 1, wherein said TCC element comprises PTC element or NTC/ZTC element, its electrical response is in the rising of temperature and change, and it comprises:
The critesistor heater material, it comprises: the polymeric substrate with conductiving doping material of 5% to 40%; Ceramic base material with conductiving doping material of 5% to 40%; The perhaps ceramic material of non-doped material, wherein, said critesistor heater material is characterised in that the resistance that changes with temperature, wherein said variation then cause the variation of the heat production of said element.
3. medical firing equipment according to claim 1, wherein said power supply is a dc-battery.
4. medical firing equipment according to claim 1, wherein said shell comprises insulating jacket.
5. medical firing equipment according to claim 1; Wherein said TCC element has around the physical form of core electricity partition at least one coil on every side; The effect of wherein said core electricity partition is that other zones that some zone electricity of said TCC element are isolated simultaneously said TCC element are electrically connected to said power supply, to form the current path through the length of said at least one coil.
6. medical firing equipment according to claim 1, wherein said TCC element have the physical form that is rolled in core electricity partition thin slice on every side, and the opposite end of said thin slice is connected to said power supply so that the current path through whole thin slice to be provided.
7. medical firing equipment according to claim 1; Wherein said TCC element has the physical form of elongated core; This elongated core has the longitudinal channel that passes it and extend to hold the said device that is used for said TCC element is electrically coupled to said power supply and said heat conduction probe; So that the current path through said elongated core is provided, wherein said probe has the electric insulation sheath, and this electric insulation sheath covers said probe and said TCC element adjacent areas.
8. medical firing equipment according to claim 1, wherein said heat conduction probe comprises one or more needle probes.
9. medical firing equipment according to claim 9, wherein said heat conduction probe comprises at least one hollow pipe, this hollow pipe is adaptive to be used to transmit material or to remove material from said target tissue.
10. medical firing equipment according to claim 9, wherein said heat conduction probe have circle, ellipse, square, rectangle or oblong shape of cross section.
11. medical firing equipment according to claim 9, wherein said heat conduction probe has round, spin, point, outstanding or blunt nosed far-end.
12. a method that is used for transmitting to tissue location heat, said method comprises:
Medical firing equipment according to claim 1 is provided;
Make electric current from the said TCC element of said power supply process, thereby with said TCC element heating;
The said tissue of said heat conduction probe is contacted distal engagement against said tissue location;
Wherein, transmit heat to tissue, this causes said probe cooling, and this fork causes said TCC element cooling and demonstrates variations in temperature, this variations in temperature then cause said resistance to change and make the temperature of said TCC element turn back to the control point.
13. a high frequency medical treatment firing equipment comprises:
Hand-held housing;
Power supply in the said shell;
Field generator, it draws electric current and generates radio-frequency current from said power supply;
At least one organizes probe;
At least two conductive segments on one or more tissue probes; And
Temperature varying coefficient (TTC) element, it has the resistance variations of scope from 2 one magnitude to 4 one magnitude in response to scope from 20 ℃ to about 80 ℃ variations in temperature;
Wherein said TCC element connected in series is between said field generator and said at least two conductive segments.
14. medical firing equipment according to claim 13, wherein said TCC element comprises NTC/ZTC element or PTC element, and this NTC/ZTC element or PTC component resistance change in response to the rising of temperature, and this NTC/ZTC element or PTC element comprise:
The critesistor heater material, it comprises: the polymeric substrate with conductiving doping material of 5% to 40%; Ceramic base material with conductiving doping material of 5% to 40%; The perhaps ceramic material of non-doped material, wherein, said critesistor heater material is characterised in that the resistance that changes with temperature, wherein said variation then cause the variation of the heat production of said positive temperature coefficient element.
15. medical firing equipment according to claim 13, wherein said power supply is a dc-battery.
16. medical firing equipment according to claim 13, wherein said shell comprises insulating jacket.
17. high-frequency ac armarium according to claim 13, it has two tissue probes and two conductive segments, and wherein each probe has a position conductive segments on it.
18. high-frequency ac armarium according to claim 13, it has three tissue probes and three conductive segments, and wherein each probe has a position conductive segments on it.
19. high-frequency ac armarium according to claim 13, wherein said at least one tissue probe can removably be attached to said shell with position at least two conductive segments on it.
20. medical firing equipment according to claim 13 comprises at least two interchangeable tissue probe assemblies.
21. medical firing equipment according to claim 20 comprises first tissue probe assembly with one or more tissue penetration tissue probes and the second tissue probe assembly with one or more surface engagement tissue probes.
22. medical firing equipment according to claim 13, wherein said field generator is adaptive to be used for optionally producing and can to stimulate and localized unidirectional current nerve, and produces high frequency electric so that handle by the localized nerve of said unidirectional current.
23. a method that is used for heat tissue comprises:
High frequency medical treatment firing equipment according to claim 13 is provided;
Transmit radio-frequency current from said field generator to said tissue probe; And
Said two conductive segments are engaged against tissue, so that said tissue is carried out Ohmic heating;
Wherein, said TCC element control electric current flows to said two conductive segments, remains in the desired range thereby electric current flowed.
24. a method of utilizing radio-frequency current to handle nervous tissue, said method comprises:
High frequency medical treatment firing equipment according to claim 22 is provided;
Transmit unidirectional current from said field generator to said tissue probe;
Said two conductive segments are engaged against tissue, neural to stimulate target;
Observe the position that said nerve is upset; And
When said probe is in observed position, transmit radio-frequency current to said tissue probe from said field generator;
Wherein, said TCC element control electric current flows to said two conductive segments, remains in the desired range thereby electric current flowed.
CN201180012016.9A 2010-01-05 2011-01-04 There is the medical firing equipment of self limiting electrical heating elements Expired - Fee Related CN102811676B (en)

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US12/652,262 US9044232B2 (en) 2010-01-05 2010-01-05 Medical heating device and method with self-limiting electrical heating element
US12/783,714 2010-05-20
US12/783,714 US8512335B2 (en) 2010-05-20 2010-05-20 High frequency alternating current medical device with self-limiting conductive material and method
PCT/US2011/020136 WO2011084957A1 (en) 2010-01-05 2011-01-04 Medical heating device and method with self-limiting electrical heating element

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