JP6054748B2 - Medical heating device with self-regulating electric heating element - Google Patents

Description

  Application No. 12 / 652,626 (filed on Jan. 5, 2010, agent case number 028486-000100 US) and application No. 12 / 783,714 (filed on May 20, 2010, agent case) No. 078486-000200 US), the entire disclosures of which are hereby incorporated by reference.

(Field of Invention)
The present invention relates generally to medical devices and methods, and more specifically, medical heating devices comprising probes that cause heating of a target tissue for tissue excision, tissue cutting, or tissue contraction, and It relates to the excitation and control of such devices.

  Medical heating devices are currently used for tissue treatment and ablation in several treatment plans. Typically, heat is generated using radio frequency induced arcing between two points or by current conduction through the body to a grounding device. Such a probe can cauterize tissue as it is excised, cut or contracted. Cauterization is the process of sealing tissue using heat conduction from a metal probe heated by an electric current, which stops bleeding from blood vessels in soft tissue. As related patents and publications of interest, Patent Document 1, US Pat. Nos. 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 No. 7,309,849, 7,476,242, and 7,483,738, US Application Publication No. 2007/0167943, PCT Application Publication Nos. WO2006 / 009705 and WO2008 / 014465. And Ramsay et al. (1985) Urol Res 13: 99-102, Hernandez-Zendejas et al. (1994) Aesth Plus Surg. 8: 41-48, Utley et al. (1999) Arch Facial Plast Surg1: 46-48, and Newman (2009) "Radiofrequency Energy for Denervation of Selected Facial Muscles: Clinical Experiencesat Six Months" The Internet Journal of Plastic Surgery, Volume 5, Number 2 is mentioned.

  Electrosurgery is the application of high frequency, usually radio frequency, electrical current to tissue as a means to cut, coagulate, dry, or discharge treat tissue. The effect includes the ability to make precise cuts in a state where blood loss is limited. Electrosurgery also includes a surgical procedure in which one or more local portions of tissue use high frequency alternating current to generate heat without heating other types of tissue near the target tissue. And excised. An electrosurgical device uses a probe-like structure to physically contact a target tissue, and such a structure can be a type of electrode that acts to pass current through the tissue. Electrosurgical devices typically do not substantially cause physical damage to tissue.

  One problem with electrosurgical (arc-based) heating devices is the risk of electrical fires that can occur in medical practice, operating rooms, or hospitals. Current conducting devices lack sufficient control of the path the current follows through the tissue, from source to ground. The amount of tissue heating that occurs is also difficult to control and potentially results in unnecessary injury as a side effect of treatment.

  Another type of medical heating device uses a resistive electrical heating element that is thermostatically controlled by a switch or thermocouple. These devices are essentially medical applications that control heat production and probe temperature by switching electrical heating elements completely on or completely off, and are more than optimal for tissue ablation or tissue cutting purposes Device ablation or cutting probe temperature variation.

  A nerve is a relatively large cell. Each neuron includes a cell body, multiple dendrites, axon fibers, and multiple axon ends. The cell body is the central part of the nerve, including the cell nucleus. Cell bodies can range from 4 to 100 micrometers in diameter. Axons and dendrites are fibers that extend outward from the cell body. Many dendrites typically surround and branch from the cell body and have a length of up to several hundred microns. An axon is a single cable-like protrusion that extends outward from the cell body and can extend over 100 times the diameter of the cell body. Axons transmit electrochemical nerve signals from the cell body and effectively control one or more muscles. The axon end is located opposite the cell body end of the axon. Typically, axon ends release chemicals from one or more muscles or other tissues or from another nerve cell in the chain of nerve cells that leads to one or more muscles or other tissues. Terminate at a branch network of synapses that communicates with other dendrites or cell bodies.

  Typically, a large number of axons from many cells are bundled together in a large conduit called the supraneuronal membrane with other nested conduits inside. In analyzing the physiological structure of these conduits, we begin with an inner conduit or sheath called the intima that directly surrounds each axon. Multiple axons are typically grouped together in small bundles and further protected by an intermediate level sheath called the perineurium. In addition, a plurality of perineural bundles of axons are typically nested within an outer sheath called the epithelial membrane. Thus, each axon is protected by the epithelial membrane, perineurium, and endoneurium from at least three sheath layers, the outermost to the innermost layer. Each large conduit or supraneuronal membrane contains many bundles of endometrial conduits, and thus completely disrupts the axons of some nerve cells, while intact the complete inner membrane of other neurons Note that it may be possible to leave.

  The Seddon system is a basic classification system used to describe nerve injury, and there are three categories of injury: neuralgia, axotomy, and nerve rupture. In the case of concussion, the integrity of the axon is preserved, so the intima, perineurium, and epithelium are all intact, but interfere with the conduction of electrochemical impulses that travel to the axon. is there. This is the mildest form of nerve injury. Neuritus is a biochemical disorder typically caused by shaking injury to cells. There is a temporary loss of function, which can be recovered within hours to months (average 6-8 weeks) of the injury.

  In the case of axonal rupture, the integrity of the axon is disturbed, but the intima, perineurium, and epithelium are not destroyed or significantly deformed. As a result, both motor and sensory functions are typically lost, but recovered through axonal regeneration, but the process occurs at a constant rate per day, typically Because of this, it takes more time than neuritus. In the case of neuritus and axotomy, the intact inner lining provides guidance for axonal regeneration, and the nerve regenerates along the inner lining tube.

  Conversely, in the case of nerve rupture, the integrity of the support structure is ruptured or destroyed, preventing axonal regrowth and reimplantation. Typically, the injury results from severe contusion, stretch, or laceration of the cell, or other internal ruptures of cellular structures sufficient to involve perturbation of the intima, perineurium, or epithelium. As a result, typically motor, sensory, and autonomic functions are completely lost. Thus, the electrochemical signal does not complete the connection to muscle or target tissue. Nerve rupture injury is typically permanent.

  A type of neuroleptic disease that is relatively transient typically results from neurotoxicity caused by local anesthesia injected into or near nerve cells. Anesthesia also interferes with the electrochemical signals transmitted to the muscle, thereby resulting in loss of movement, sensation, and autonomic function. Botulinum toxin or Botox®, used in conjunction with popular cosmetic procedures for hemorrhoids, acts on the neuromuscular junction, blocking transmission between nerves and muscles, resulting in muscle paralysis, Used as a neuromodulator to reduce

  For these reasons, it would be desirable to provide a self-controlling medical heating device that improves control over the location and amount of tissue heating and provides improved safety for both patients and operators. In addition, through current heating means, it provides the ability to affect a wide range of cell damage, from minimal levels of concussion to complete nerve rupture, while minimizing simultaneous physical damage to other tissues in the target area It would be desirable to do. Furthermore, it would be desirable to provide the patient with a temporary effect or sustained relief without cosmetic defects in the surface tissue. At least some of these objectives will be met by the present invention described below.

US Pat. No. 4,026,300

The present invention provides, for example:
(Item 1)
A medical heating device,
A portable enclosure;
A power source in the enclosure;
A thermally conductive probe extending from an end of the inclusion body having a tissue contacting distal end;
A temperature coefficient of change (TCC) element that forms a miniature heater having a resistance change in the order of 2 to 4 in response to a temperature change in the range of 20 ° C to about 80 ° C ;
The medical heating device, wherein the thermally conductive probe is coupled to the TCC element and transfers heat from the TCC element to the tissue contacting distal end.
(Item 2)
The TCC element includes a PTC or NTC / ZTC element whose resistance changes in response to a temperature increase, and the PTC or NTC / ZTC element includes:
Comprising a thermistor heater material, the thermistor heater material comprising a polymer-based material with 5-40% conductive dopant material and 5-40% conductive dopant material in a ceramic material without dopant material The thermistor heater material is characterized by an electrical resistance that varies with temperature, the variation causing variations in heat production from the element. Medical heating device.
(Item 3)
Item 2. The medical heating device according to Item 1, wherein the power source is a direct current battery.
(Item 4)
Item 2. The medical heating device according to Item 1, wherein the enclosure includes a heat insulating jacket.
(Item 5)
The TCC element has a physical form of at least one coil wound around a core electrical spacer, the core electrical spacer electrically separating several regions, but other than the TCC element The medical heating device of item 1, wherein the medical heating device is operative to electrically connect a region of the power source to the power source and to provide a current path through the length of the at least one coil.
(Item 6)
Item 2. The TCC element has a physical form of a sheet wound around a core electrical spacer, and both ends of the sheet are connected to the power source to provide a current path through the sheet. Medical heating device.
(Item 7)
The TCC element has a physical form having a longitudinal channel running through the TCC element on an elongated core, the elongated core electrically coupling the TCC element to the power source and the thermally conductive probe; Item 2. The medical heating device of item 1, storing means for providing a current path through the elongated core, the probe having an electrically insulating sheath covering a region of the probe adjacent to the TCC element.
(Item 8)
Item 2. The medical heating device according to Item 1, wherein the thermally conductive probe comprises one or more needle-shaped probes.
(Item 9)
10. The medical heating device of item 9, wherein the thermally conductive probe comprises at least one hollow tube adapted for delivering or removing material from a target tissue.
(Item 10)
Item 10. The medical heating device of item 9, wherein the thermally conductive probe has a cross-sectional shape that is circular, elliptical, square, rectangular, or oval.
(Item 11)
Item 10. The medical heating device of item 9, wherein the thermally conductive probe has a distal end that is a round lip, a rotating ball, a puncture, a sharp, or a blunt.
(Item 12)
A method of delivering heat to a tissue location,
Providing a medical heating device according to item 1;
Passing a current through the TCC from a power source so that the element TCC element heats;
Engaging a tissue contacting distal end of the thermally conductive probe with respect to the tissue location;
Heat is delivered to the tissue, causing the probe to cool, which causes the TCC element to cool, causing a temperature change that changes the resistance and returns the temperature of the TCC element to a control point. ,Method.
(Item 13)
A high-frequency medical heating device,
A portable enclosure;
A power source in the enclosure;
An electric field generator that draws current from the power source and generates radio frequency current;
At least one tissue probe;
At least two conductive sections on one or more tissue probes;
A temperature coefficient of change (TCC) element having a resistance change in the range of magnitude on the order of 2 to 4 in response to a temperature change in the range of 20 ° C to about 80 ° C ;
The high frequency medical heating device, wherein the TCC element is in series between the electric field generator and the at least two conductive sections.
(Item 14)
The TCC element includes a PTC or NTC / ZTC element whose resistance changes in response to a temperature increase, and the PTC or NTC / ZTC element includes:
Consisting of a thermistor heater material, the thermistor heater material being a polymer based material with 5% to 40% conductive dopant material, a ceramic based material with 5% to 40% conductive dopant material in the ceramic material, Or a ceramic material without dopant material, wherein the thermistor heater material is characterized by an electrical resistance that varies with temperature, said variation causing variations in heat production from said element, The medical heating device as described.
(Item 15)
Item 14. The medical heating device according to Item 13, wherein the power source is a direct current battery.
(Item 16)
Item 14. The medical heating device according to Item 13, wherein the enclosure includes a heat insulating jacket.
(Item 17)
14. The high frequency alternating current medical device of item 13, with two tissue probes and two conductive sections, each probe having one conductive section located thereon.
(Item 18)
14. A high frequency alternating current medical device according to item 13, comprising three tissue probes and three conductive sections, each probe having one conductive section located thereon.
(Item 19)
14. The high frequency alternating current medical device of item 13, wherein the at least one tissue probe and at least two conductive sections located thereon are removably attachable to the enclosure.
(Item 20)
14. The medical heating device of item 13, comprising at least two replaceable tissue probe assemblies.
(Item 21)
21. The medical heating device of item 20, comprising a first tissue probe assembly with one or more tissue penetrating tissue probes and a second tissue probe assembly with one or more surface engaging tissue probes. .
(Item 22)
The electric field generator selectively produces a direct current capable of stimulating a nerve to identify a position, producing a high frequency current and treating the nerve located by the direct current; 14. The medical heating device of item 13, wherein the medical heating device is adapted to perform.
(Item 23)
A method of heating tissue,
Providing a high-frequency medical heating device according to item 13,
Passing a radio frequency current from the electric field generator to the tissue probe;
Engaging the two conductive sections to tissue and ohmically heating the tissue;
The TCC element controls current to the two conductive sections and maintains the current within a desired range.
(Item 24)
A method of treating neural tissue with a radio frequency current comprising:
Providing a high-frequency medical heating device according to item 22,
Passing a direct current from the electric field generator to the tissue probe;
Engaging the two conductive sections to tissue and stimulating a target nerve;
Observing where the nerve is stimulated;
Passing a radio frequency current from the electric field generator to the tissue probe while the probe is at the observed location;
The TCC element controls current to the two conductive sections and maintains the current within a desired range.
In a first aspect of the invention, a medical heating device comprises an electrical resistance heater element formed from a self-controlling conductive material. Self-regulating conductive materials are preferably associated with temperature so that heat production from the current through the material automatically varies with temperature and preferably controls the temperature at or near the target control value. It can be a conductive polymer or a conductive ceramic material characterized by a variable electrical resistance. The enclosure is typically a thermally insulated jacket and typically includes at least a portion of a heater element that can also be connected to a power source, eg, by wiring, which is also within the enclosure. A thermally conductive probe extends outwardly from a jacket or other enclosure and is thermally coupled to an electrical heater element. A medical heating device is used to either end the probe for thermal excision, denervation, cutting, or contraction of the tissue, or to apply the heated material to the target tissue if the probe is a hollow tube. A section or other exposed surface can be used in a method in which the target tissue is contacted. Since the temperature of the probe is self-regulating, due to the temperature-dependent resistance of the conductive material used for the heater element, the device has an “self-controlled” operating temperature, and overheating of the target tissue and Insufficient heating is reduced or avoided.

  In a second aspect of the invention, a radio frequency or other high frequency electric field is applied across the target tissue to “conduct” the current across the target tissue. Heat is generated from this current by ohmic or joule heating, and the heat so generated is proportional to the square of the amount of this current. A “lesion site” is generated where the tissue is heated above ambient temperature. Heating occurs in a very controlled manner so that the temperature of the lesion site does not rise above the maximum temperature. Carefully controlled heating provides the opportunity to produce the desired precise cell injury. Heat generation at the lesion site is controlled by a self-regulating conductive material electrical component in electrical series with the current in the target tissue. Self-regulating conductive material electrical components precisely control the current flowing across the target tissue.

  Thermogenesis and temperature rise in the tissue is directly proportional to the amount of high-frequency current that passes through the tissue, and the duration and extent of the elevated temperature directly, along with the location and size of the lesion site, mainly the type of cell damage and Determine the extent and, in turn, determine whether the desired precise cell injury is achieved. Thus, the present invention uses precise high frequency current control to provide the precise minimum level of cytotoxicity required to produce the desired result in the patient without exceeding this level, thereby It produces results without unnecessary cell damage.

  The present invention may be used in medical, dental, or veterinary applications. Exemplary embodiments of the present invention have cosmetic applications, including hemorrhoid treatment and subcutaneous tissue remodeling. Exemplary embodiments are also used for therapeutic applications, including treatment of muscle spasms and chronic pain and control of one or more muscles of other target tissues. Exemplary embodiments provide that the desired cytotoxicity causes nerve / muscle contractile function, temporarily or persistently “kills” the nerve between muscles, or breaks the electrochemical connection. Designed to have a specific effect on neural tissue. However, since the manufacturing technique changes over time compared to the size of the particular cell of interest (cells can be human or any other known type), the present invention is on the device of the present invention. Only within the limits of the relative probe / needle size can be used to cause the desired precise cellular injury to any type of cell or organ in the body. Other specific uses include cauterization, i.e., stopping bleeding by applying heat, treating migraine by killing the trigeminal nerve.

  Accordingly, the present invention provides a high frequency alternating current medical device and a method of using the same. The medical device can be a portable battery-operated low power miniature electricity generator that can combine high frequency alternating current and direct current delivery with current controlled by self-regulating conductive materials. A high frequency alternating current medical device according to the present invention comprises a power source, an electric field generator, a self-controlling conductive material electrical component, at least one probe or needle projection, and at least one probe or needle projection. At least two conductive sections located. The at least two conductive sections are electrically connected to an electric field generator so that an electric field is generated between the conductive sections and operates in a bipolar manner. The electric field generator induces or generates an electric current having an alternating current property in the target tissue, and generates heat in a target tissue such as nerve tissue, thereby causing certain desired precise cell injury. The electric field generator also generates a non-therapeutic pulse that is used to detect nerve cells by constricting the muscles to the nerve prior to the therapeutic treatment or by inducing another observable response. Can be produced. The desired precise cell injury can be from neurochumbria to complete nerve rupture, thereby producing a nerve / muscle contractile function, either transiently or persistently between the nerves and muscles. Disconnect the connection. Self-controlled conductive electrical components control the current in the target tissue, act to prevent overheating of the target tissue, and vary in its electrical conductivity with its temperature To do that through the intrinsic properties of the material, the self-regulating conductive material electrical component allows such precise cell injury by its placement in electrical series connection with current passing through the target tissue To do. Self-controlling conductive material electrical components behave electrically like a thermistor, thermocouple, or switch. The self-regulating conductive material can be a positive temperature coefficient (PTC) material, a negative temperature coefficient (NTC) material, a zero temperature coefficient (ZTC) material, or a combination thereof. The high frequency alternating current medical device can be small enough to be portable. The power source, electric field generator, self-controlling conductive material electrical component, at least one probe or needle projection, and at least two conductive sections are comfortably held and very effective by the surgeon performing the surgery Can be integrated into a single device that is small and lightweight enough to be handled.

Thus, in a specific aspect of the present invention, a medical heating device includes a power source and an end of an enclosure, typically a distal end, and a thermally conductive probe having a tissue contacting distal tip. And a change in resistance, usually with PTC, a temperature change in the range of 20 ° C. to about 100 ° C. , typically 30 ° C. to about 80 ° C. In some applications, a temperature coefficient of variation (TCC) element, typically a positive temperature coefficient (PTC), that rises in the range of magnitude on the order of 2 to 4 in response to ) Comprising a portable enclosure defining an interior for storing elements or a combination of negative temperature coefficient (NTC) and zero temperature coefficient (ZTC) elements. That is, the resistance value measured in ohms typically increases (or otherwise decreases) by a magnitude on the order of 2 to 4 when the temperature of the TTC material changes in magnitude within these temperature ranges. ) Will do. By passing a current through the TTC element, the temperature of the material is increased and the thermally conductive probe is coupled to the TTC element and conducts heat from the TTC element to the tissue contacting distal end of the thermally conductive probe. In this way, the distal tip of the probe can contact the tissue and conduct heat generated within the TTC element. As heat is conducted to the probe, the temperature of the TTC material will cool, thus resulting in a drop in resistance within the PTC material. As the resistance falls, the current through the PTC will increase, thus restoring temperature to the point of variation in the PTC curve (FIG. 8), as described later in this application.

  The medical heating device will preferably comprise a PTC element having a specific composition, as described later herein. An exemplary power source is a direct current battery, and the exemplary enclosure will include a thermal jacket. The PTC element can take a variety of forms. For example, the PTC element may be in the form of at least one coil wound around the core electrical spacer, the electrical core spacer functioning to electrically isolate several regions of the PTC element while the PTC element The other areas of the element are electrically connected to the power source and provide a current path through the length of the coil. Alternatively, the PTC element can be in the form of a sheet wound around the core electrical spacer, with both ends of the sheet connected to a power source and providing a current path through the entire sheet. Thirdly, the PTC element may be in the form of an elongated coil with or without a longitudinal channel extending therethrough, connecting the PTC element to a power source. The thermally conductive probe can take a variety of forms, typically a needle-shaped probe, optionally a hollow tube having any one of a variety of circular shapes. Alternatively, the probe may have an atraumatic distal tip that is a lip, a rotating ball, a blunt, etc.

  The medical heating device described above can be used to deliver heat to a tissue location. Current is passed from the power source through the TCC or PTC element such that the TTC or PTC element heats up. The tissue contacting distal end of the thermally conductive probe is engaged against the target tissue location and heat is delivered to the tissue. As described above, the delivery of heat causes the probe to cool, which in turn causes the PTC element to cool and lower its resistance. As the resistance falls, the current will increase, thus generating more heat and restoring the PTC element to the inflection point.

  In a further aspect of the present invention, the high frequency medical heating device comprises a portable enclosure having a suitable internal cavity for holding various device components. Both the power source and the electric field generator are stored in the enclosure. An electric field generator draws current from a power source, typically a battery, and generates radio frequency (RF) or other high frequency current. At least one tissue probe is coupled to the portable enclosure and has two conductive sections (or optionally, one conductive section on two or more tissue probes) thereon, the conductive section Is adapted to engage tissue and deliver RF energy. A temperature coefficient of change (TCC) material, preferably a positive temperature coefficient (PTC) element, similar to that described above, is also disposed within the portable enclosure and connected between the electric field generator and the power source. As the electric field generator delivers more energy to the conductive section, the current through the PTC element will increase, thus heating and raising the temperature. The temperature increase will reduce the current delivered to the electric field generator, reduce the amount of current, and control the current to the desired target level.

  In a preferred aspect of this embodiment, the tissue probe can be provided on an assembly that is removably or detachably connected to the enclosure so that different tissue probes can be interchangeably attached to the enclosure. For example, a tissue probe assembly having a single tissue probe, a pair of tissue probes, or three tissue probes can be provided such that it can be interchangeably connected to a portable enclosure. In some cases, the tissue probe may be tissue penetrating for treatment. In other cases, the tissue probe may be non-tissue penetrating, particularly when the portable device is used for neural stimulation. In such cases, the electric field generator will selectively deliver radio frequency energy, or a type and scale that will stimulate the nerve when the tissue probe is engaged against the patient's skin. Will be adapted to deliver direct current energy, typically direct current. This is particularly advantageous for identifying nerves that can then be treated with RF energy after the probe assembly has been replaced with a tissue penetrating probe assembly.

FIG. 1A is a perspective view of an exemplary handpiece that includes a self-controlling electrical heating element, an insulation jacket, a cutting probe, and a circuit connection to a power source. 1B and 1C are perspective views of alternative handpieces in accordance with the present invention. 1B and 1C are perspective views of alternative handpieces in accordance with the present invention. 2A and 3A are partially cutaway perspective views of the probe distal end of the first and second embodiments of a medical heating device, respectively, illustrating two different heating element arrangements. 2B and 3B are cross-sectional views of FIGS. 2A and 3A. 2A and 3A are partially cutaway perspective views of the probe distal end of the first and second embodiments of a medical heating device, respectively, illustrating two different heating element arrangements. 2B and 3B are cross-sectional views of FIGS. 2A and 3A. 4 and 5 are partially cutaway perspective views of the probe distal end of the third and fourth embodiments of the medical heating device, respectively, in FIG. Now, an optional sensor is illustrated. 4 and 5 are partially cutaway perspective views of the probe distal end of the third and fourth embodiments of the medical heating device, respectively, in FIG. Now, an optional sensor is illustrated. FIG. 5A is a cross-sectional view of FIG. FIG. 6 is a circuit diagram of the medical heating device. FIG. 7 is a logarithmic graph of electrical resistance (ohms) versus temperature (C) for a preferred PTC self-regulating electric heating element. FIG. 8 is a logarithmic graph of electrical resistance (ohms) versus temperature (C) of a self-controlling electrical heating element compared to that of an on / off switch. 9A, 9B, 9C, and 9D depict logarithmic graphs of electrical resistance (ohms) versus temperature (C) for NTC, ZTC, NTC / ZTC mixed materials and PTC / ZTC mixed materials. 9A, 9B, 9C, and 9D depict logarithmic graphs of electrical resistance (ohms) versus temperature (C) for NTC, ZTC, NTC / ZTC mixed materials and PTC / ZTC mixed materials. 9A, 9B, 9C, and 9D depict logarithmic graphs of electrical resistance (ohms) versus temperature (C) for NTC, ZTC, NTC / ZTC mixed materials and PTC / ZTC mixed materials. 9A, 9B, 9C, and 9D depict logarithmic graphs of electrical resistance (ohms) versus temperature (C) for NTC, ZTC, NTC / ZTC mixed materials and PTC / ZTC mixed materials. FIG. 10 illustrates electrical for various conductive polymer-based materials with different polymer softening points for use in selecting an appropriate conductive polymer material for a specified tissue ablation or tissue cutting application. FIG. 5 is a logarithmic graph of resistance (for resistance at 25 ° C.) versus temperature (C). FIG. 11 is a circuit diagram of the basic mode of a medical device with two probes or needle projections. FIG. 11A is a circuit diagram of the basic mode of the medical device with one probe or needle projection. FIG. 12 is a circuit diagram of an exemplary medical device constructed in accordance with the principles of the present invention. FIG. 13 shows a perspective view of an exemplary medical device with a replaceable tip attached and removed, each with an enlarged view. FIG. 13A shows an alternative replaceable tip with a non-penetrating electrode intended for nerve stimulation at the surface of the skin. FIG. 14A is a cross section of a medical device. FIG. 14A. FIG. 14B is a top plan view of the medical device. FIG. 14B also defines a cross-sectional plane 14A. FIG. 14C is a cutaway view of FIG. 14B. FIG. 15 is an enlarged view of a side elevational view of the distal end of the medical device. FIG. 16 is an enlarged top plan view of the distal end of the medical device.

  The present invention provides medical devices and methods of using the same. A medical device according to the present invention comprises at least one probe or needle projection at its distal end and at least two conductive sections located on the at least one probe or needle projection. At least one probe or needle projection can be inserted into the body cavity or body tissue, and at that point can conduct current between at least two conductive sections. In the “one probe or needle projection” mode, at least two conductive sections are located on only one probe or needle projection. In the “two probe or needle projection” mode, one of the at least two conductive sections is typically located on each of the two probes or needle projections. Probes or needle-shaped protrusions are typically inserted into or near tissue, or a body cavity containing target cells. A current is then conducted between the sections, causing the desired precise cell injury. The probe or needle projection can be inserted into the tissue so that the current is generated subcutaneously. In this manner, the heat-defined lesion site is entirely subcutaneous, resulting in minimal changes in the appearance on the surface of the tissue. The medical device further includes a power source capable of applying a therapeutically or diagnostically effective electric field across the at least two conductive sections to generate an appropriate current in the target tissue. The power source can be an alternating current and / or a direct current.

  In certain embodiments, the medical device further comprises an electric field generator that is powered by a power source and capable of generating one or more electric fields across at least two conductive sections. Preferably, the electric field generator is small and small. The electric field can be generated in a sinusoidal, triangular, or square wave, or similar continuous waveform, and at various frequencies, intensities, and polarizations to provide the desired heating and produce the desired precision cell injury . Alternatively, the electric field may have a direct current pulse nature, as well as a sinusoidal, triangular, or square wave, or similar pulse shape. The electric field generator can emit several differently shaped pulses and continuous waveforms simultaneously. An exemplary electric field generator can be small enough to be portable, but can also supply a 3 watt electric field at 150 ohms at 460 KHz using a portable direct current battery power supply, More or less power can be delivered depending on battery strength and other conditions.

  The medical device of the present invention further comprises a self-regulating conductive material electrical component in electrical series connection with a current passing through the target tissue. A “self-regulating conductive material” is defined as a material whose electrical resistance characteristics vary with temperature. Self-regulating conductive material electrical components function electrically like a thermistor, thermocouple, or switch in the electrical heating circuit of the target tissue. The self-controlling conductor material electrical component effectively controls the current passing through the target tissue and thus controls the temperature of the target tissue and the tissue surrounding the target tissue. In particular, as described below, a preferred self-regulating conductive material is advantageously provided that has a thermistor temperature response curve for use in the device of the present invention.

  The entire medical device can be small enough to be portable. The power source, electric field generator, self-controlling conductive material electrical component, at least one probe or needle projection, and at least two conductive sections are comfortably held and very effective by the surgeon performing the surgery Can be integrated into a single device (common enclosure) that is small and lightweight enough to be handled.

  The medical heating device 10 (FIGS. 1-5) includes a self-controlling electrical heating element 20 that is electrically coupled to a power source 30 (FIG. 6) by an electrical wire circuit connection 40. As will be described later, the medical heating device 10 further includes a heat insulating jacket 50, a thermally conductive probe 60, and a core electrical spacer 70.

  The self-regulating electric heating element 20 behaves electrically like a standard electric heating element connected in series with a thermistor. Accordingly, in FIG. 6, the self-controlling electric heating element 20 is represented by an electric heating element symbol 26 connected in series with a thermistor symbol 23. The thermistor characteristic effectively regulates the current through the electrical heating element characteristic. Indeed, the self-controlling electrical heating element 20 is essentially one electrical component consisting of a homogeneous mixture of different materials, including a substrate and a conductor dopant, as detailed below.

The self-regulating electric heating element 20 behaves like the electric heating element 26 because the heat it produces arises primarily from electron, ion, or other charged particle collisions that occur inside the heating element. Such heat-generating collisions are induced by an electric field across the heating element that is generated by the voltage V and current I from the electrical wire circuit connection 40 through the heating element to the power supply 30. See FIG. This phenomenon is known as ohmic heating, joule heating, or resistance heating. As with ohmic heating, the amount of heat Q produced from the present invention is proportional to the square of the current passing through the self-regulating electric heating element 20, ie, Q∝I ² .

  Since its electrical resistance R varies as a function of temperature T (which is a thermistor definition), the self-controlling electrical heating element 20 behaves like a thermistor 23. Since this relationship is typically non-linear, we use a logarithmic measure of resistivity that is used to illustrate its relationship with temperature (FIGS. 7-10). If the resistance increases with increasing temperature, the device is called a positive temperature coefficient (PTC) thermistor or posistor. If the resistance decreases with increasing temperature, the device is called a negative temperature coefficient (NTC) thermistor. Resistors are called zero temperature coefficient (ZTC) materials, which are designed to have a constant resistance over a wide temperature range and are sometimes a subset of another thermistor. Collectively, PTC, NTC, and ZTC materials are referred to herein as temperature coefficient of change (TCC) materials.

Both the ohmic heating and temperature response resistance characteristics regulate the temperature of the self-controlling electric heating element 20. The temperature change of the medical cutting device caused by using the device causes a resistance change. The resistance is inversely proportional to the current, i.e., R∝I- ¹ . As mentioned above, the heat produced is proportional to I ² and is therefore Q∝1 / R ⁻² . Thus, a small change in resistance results in a relatively large heat production change from the self-regulating electric heating element 20. However, if the resistance becomes too large, there is a maximum R that makes electrical circuit connection between the power source and the heater element 20 impossible. Above this temperature, the heater is shut off, resulting in rapid cooling.

In a specific and preferred embodiment, the self-controlling electric heating element 20 is made of a PTC material. FIG. 7 is a graph of electrical resistivity versus temperature for a PTC heater material suitable for use in the present invention. The preferred method has a resistivity that gradually increases with temperature, as seen by the positive slope characteristic (between T _L and T _H ) of the intermediate level of the graph. Furthermore, in the T _0, an inflection point exists in the graph. As the temperature rises above T ₀ , the resistivity rises while decelerating with temperature. Therefore, the temperature is, as the increase above the T _0, moderate heat production decreased while decelerating exists. As the temperature falls below T ₀ , the resistivity decreases with deceleration, decelerating. Therefore, the temperature is, as the drops below the T _0, a gradual increase is present in heat production while decelerating. Referring to FIG. 7, from T ₀ to T _H , the resistivity gradually increases, thereby reducing heat production, thereby cooling the heater element to T ₀ . Similarly, from T ₀ to T _L , the resistivity gradually decreases, thereby increasing heat production, thereby heating the heater element to T ₀ . At T ₀ there is another mathematically stable temperature point, otherwise known as an inflection point. Materials with the inflection point relationship maintains the device to be stably set to T _0, has optimal stability, resulting in optimum properties of the present invention. Thus, PTC heaters allow “automatic temperature control” or an essentially stable temperature T ₀ when placed in a sufficiently strong electric field to induce a heat producing current. In addition, the steady state temperature remains at T ₀ over a wide range and over a variation in voltage from the DC or AC current source 30.

Any standard electrical heating element combined with a “thermostat switch” or thermocouple can provide “on-off” control with temperature oscillations centered on T ₀ . However, such on-off control requires an offset “hysteresis” between the on and off temperatures, T _L and T _H , resulting in significant temperature fluctuations centered on T ₀ . In contrast, the self-controlled electric heating element 20 provides more stable control with less variation. Referring to FIG. 8, T ₀ is 75 ° C. In the case of a switch, the heater is either completely on or completely off. As a result, the heater circulates continuously from extremely high heat production to zero heat production, targeting the target temperature T ₀ . On the other hand, in the present invention, electrical resistance with temperature, gradually changes observed, whereby while minimizing vibration about the target temperature T _0, gradually only, changing the heat production.

Below the transition temperature T ₀ , the composition used for the switch has a very low resistance of about 10 ohms or less. Therefore, the on - off switch, at just the temperature below the T _0, fully turn on the heater. On the other hand, the exemplary self-regulating electric heating element 20 of the present invention drops only to about 1000 ohms, thereby causing only a slight increase in heat production at the same temperature. Above the transition temperature, the switch will have a very high resistance of about 10 ⁹ ohms or greater. The switch therefore turns off the heater completely. In contrast, the self-regulating electric heating element composition of the present invention has only a slightly higher resistance at this temperature, and therefore the heat output is only slightly reduced. Furthermore, in the case of a medical heating device, the device will receive a significant endotherm while it is in full contact with the tissue, and a stationary device that will only contact air after a moment will not receive any endotherm. This temperature fluctuation is exacerbated. Thus, the thermistor-type heating element 20 of the present invention, compared to prior art medical heating devices controlled by an on-off temperature switch, while allowing rapid variation in endothermic activity associated with tissue resection of the cut, A medical heating device with a much constant target temperature is provided.

The inflection point relationship between the resistivity and the temperature of the PTC material is a self-regulating electric heating element 20 with a relatively small temperature deviation around T ₀ only a few degrees, eg 3-10 ° C. Is more preferable. Thus, when T _H and T _L are exposed to medical applications, respectively, the control range (T _H -T _L ) is the switch-actuated medical heating device element when it is the respective maximum and minimum temperature of the heater system. In comparison with the self-regulating electric heating element, it will be much smaller. The exemplary heating element 20 will typically provide a material with a temperature control range of about 3 ° C to 5 ° C that is used as a thermistor in a medical heating device.

Different tissue excision or cutting procedures may require different optimum temperature operating ranges. For example, different procedures may require different shapes and sizes of cutting probes, thereby changing the endothermic requirements, thereby changing the heat production and temperature range of the medical heating device. Different target tissues are excised in different procedures, which may require different optimal cutting temperature ranges for the medical heating device for each procedure. Thus, certain tissue excision or cutting procedures may require different target temperatures T ₀ with different operating ranges T _H to T _L. These criteria can be adjusted by carefully selecting the PTC, NTC, or ZTC heater material for the self-controlling electric heating element 20 with the best resistance temperature graph. In addition, different dopants and different concentrations of dopants can be used to vary the properties and produce different resistance temperature graphs. Additional combinations of PTC, NTC, and ZTC materials can be used to provide different resistance temperature graphs. Many of these materials are currently commercially available.

FIG. 9A includes the resistance temperature relationship of the NTC material. This arrangement can be used to produce an operating temperature T ₀ at such temperatures with a sharp cut. FIG. 9B includes the resistance temperature relationship of the ZTC material. This arrangement can be used to produce a constant heat output at a certain level over a wide range of temperatures _TH to _TL . FIG. 9C includes the resistance temperature relationship of the NTC / ZTC blend material. This arrangement, in one level, accompanied by a constant heat output at a temperature T _L, accompanied by sharp cutting can be used to produce a wide operating temperature range T _L from T _H. FIG. 9D includes the resistance temperature relationship of the PTC / ZTC blend material. This arrangement, in one level, accompanied by a constant heat output at a temperature T _L, accompanied by rapid increase in heat production, it is used to generate a wide operating temperature range T _L from T _H, whereby, The probe temperature can be prevented from further below _TL .

PTC, NTC, and ZTC materials can consist of crystalline or semi-crystalline polymer-based materials with the addition of certain conductive “doping” materials. For polymer-based thermistors, the transition temperature results from the melting or freezing of the polymer molecules. In the case of crystalline or semi-crystalline polymers, the molecular structure is tightly packed in the solid phase and low density in the liquid phase. Polymer molecules are generally non-conductive, and therefore a conductive dopant must be added to make the material conductive. At temperatures below T ₀ , most polymer molecules are in the solid phase and are therefore tightly packed and therefore in their most conductive state or level. At temperatures above T ₀ , most polymer molecules are in the liquid phase and are therefore packed to a low density and are therefore in their least conductive state or level. For the same choice of matrix polymer, the transition temperature T ₀ is generally consistent with the polymer softening point of the selected matrix polymer. In FIG. 6, both switches and heaters are made of the same type of polymer material and therefore have the same transition temperature T ₀ .

Materials having these properties with a range of transition temperatures T ₀ are well known and commercially available. FIG. 10 illustrates the different transition temperatures of a possible polymer matrix for a conductive polymer composition. Therefore, the continuously rising transition temperatures are: polyvinyl stearate, polycaprolactone (PCL), ethylene ethyl acrylate (EEA), low density polyethylene (LDPE), high density polyethylene (HDPE), polypropylene (PP), polyfluorinated Vinylidene (PVF2), polyvinyl fluoride (PVF), tetrafluoroethylene-ethylene copolymer (ETFE), perfluoroalkoxyethylene copolymer (PFA), tetrafluoroethylene / hexafluoropropylene copolymer (FEP), etc. Found in the case of conductive polymers produced using the matrix of Table I shows the crystalline melting points of some polymers. Conductive polymer compositions that can be used in conjunction with the present invention include these polymers as well as US Pat. Nos. 4,514,620 and 5,554,679, the full disclosures of which are hereby incorporated by reference. ) May be included. PTC, NTC, and ZTC materials can also be produced from a mixture of two or more conductive polymers.

  The dopant material is added to the substrate to make it conductive so that the material can function like a heating element. The dopant is also added to slow down the resistance change or to enlarge the graph. The dopant is a conductive material such as carbon black, metal oxides, semiconductor materials, mixtures thereof, or other materials that are conductive and can be produced in small particles. Specific resistance-temperature relationships for PTC, NTC, and ZTC materials are achieved by varying the dopant type and concentration. For example, the switch in FIG. 8 has the same type of dopant as the self-controlling electrical heating element, but the self-controlling heating element is much smaller and has a uniformly distributed concentration of dopant. Thus, reducing the concentration or density of conductive particles in a polymer-based composition is one way to obtain the desired gradual resistance change for a self-regulating heater element. In general, a dopant level above 50% results in a switched material, a dopant level of 15-40% results in a thermistor material, and a dopant level of 10% results in electromagnetic interference or electrostatic discharge. Also, the porosity, surface area, particle size, and oxygen content of the conductive dopant can be varied to produce various properties. Also, more than one type of dopant can be added to the substrate. Either the substrate molecule or the dopant material particles can actually cause ohmic heating. Thus, the dopant can function to produce electron transfer, or vibrational heating, or both. All of these factors, along with various carbon black loading levels and others, along with the substrate type, result in an almost infinite amount of combinations between dopant type and amount, and an almost infinite amount of specific resistance temperature relationship Bring.

PTC, NTC, and ZTC materials can also consist of ceramic materials or ceramic-based materials with added conductive dopants. The ceramic material can be conductive or non-conductive, depending on the phase. Ceramic materials can be designed to change phase from solid to liquid or from liquid to solid at a particular temperature T ₀ . Typically, the ceramic-based material is barium titanate and / or related divalent titanate and zirconate. Typical dopants include lead, strontium, rare earth metals, antimony, bismuth, or the like. Dopants are added to increase or decrease the substrate's exceptional range, or to further adjust the resistance temperature related slope. Various ceramic thermistor heaters are commercially available with different temperature resistivity relationships. Also, ceramic thermistor heater material manufacturers may attempt to launch special development programs that specifically deliver the desired properties.

  Typically, the particular self-controlling electrical heating element 20 is selected based on the requirements of the medical procedure, particularly the desired operating temperature range for the particular tissue ablation to be performed. Suitable self-regulating electric heating element materials can be selected to provide this temperature range regardless of PTC, NTC, ZTC, or combinations thereof. Note that the size, shape, and conductivity of both the probe and the insulating material, as well as other factors, affect the operating temperature range of the probe and heater. All affected aspects are taken into account in the calculations performed to produce the desired resistance temperature graph. The best commercially available thermistor material with the best resistance temperature graph is then selected to suit the specific medical procedure desired.

  The physical form of a suitable self-controlling electrical heating element 20 may comprise or consist of one or more rings or loops 22 of PTC / NTC / ZTC material wound around a core electrical spacer 70. See FIG. 2A. The core electrical spacer 70 maintains the pair of circuit connection wires 40 in a separated state in order to prevent a short circuit. The individual loops 22 of the heating element 20 are connected in parallel with the electrical wire circuit connection wires 40 and can provide a set of current paths through the loops 22. Alternatively, the two end loops 22 of the heating element 20 may be connected to the wire 40 and provide a current path along the entire length of the heater 20.

  As seen in FIG. 2B, the core electrical spacer 70 houses the longitudinal passage of the wire 40 as well as one or more thermally conductive probes 60, or possibly a sensor (not shown here). It has a cross section with grooves or channels. In particular, the core electrical spacer 70 may have a set of longitudinal bays 73 having a shape that closely fits the respective wire 40, probe 60, or sensor component received therein.

  The self-controlling electrical heating element 20 may alternatively consist of a sheet form 24 of PTC / NTC / ZTC material wound as a bracket around the core electrical spacer 70 (FIGS. 3A and 3B). Sheets 24 are connected along the length of wire electrode 40 to provide parallel current paths throughout sheet 24. Another possible arrangement would simply be to have one wire 40 contact the sheet 24 at the distal end and another wire 40 adhered to the sheet at the proximal end. .

  Yet another alternative would be to employ a core electrical spacer 70, which itself consists of a self-controlled conducting PTC / NTC / ZTC material. Since the wire 40 extends through the entire length of the core spacer 70, current will flow in parallel through the bulk of the spacer material and produce heat. Some commercially available self-regulating heater cables that are marketed for use as storage tank heaters, ground heaters, pipe freeze protection, or temperature maintenance for domestic hot water systems are the Raychem trademark. In its name, it may have a structure as manufactured from Tyco Thermal Controls, LLC. In such a structure, the probe 60 would need to be insulated from the conductive spacer material 70, for example by having an insulating cladding.

  In addition to the core electrical spacer 70, in the embodiment of FIGS. 2A / B and 3A / B, there may be another electrical spacer, referred to as a rim electrical spacer 75. The rim spacer 75 is an electrical insulator in some areas and is thermally conductive in other areas. An electrically insulating material would be required during the entire self-regulating heater 20 and circuit connection wire 40 where conductivity is not desired. This pattern will be different for a series heater connection compared to a parallel heater connection. For example, in FIG. 3A, longitudinal slits will exist over the entire length of the rim spacer 75, providing the aforementioned parallel loop connection. Further, the rim electrical spacer 75 needs to be thermally conductive in other regions, for example, in the vicinity of the probe, so that heat can be freely transferred from the heater 20 between the rim spacers 75 to the probe 60. Will.

  The thermal jacket 50 (FIGS. 2A / B and 3A / B) can provide at least a portion of the outer surface of the handpiece or handle. The jacket 50 functions to insulate the heat generated by the heating element 20, maintain the heat within the device, and provide a non-heated handle for the user to easily control the tissue ablation device. Although not depicted in the drawings, the jacket 50 typically extends generally to cover the core electrical spacer 70. In FIG. 1A, the insulation jacket 50 has an external shape similar to a pen. This shape is believed to deliver superior control and feel of the device as a surgical female device. FIG. 1B illustrates a jacket 50 having a thicker handle, such as the handle found in a screwdriver. The jacket 50 may take any external form that has proven most desirable to the user.

The insulation jacket 50 will typically cover all electronic circuitry in the handpiece. The jacket 50 is preferably made of a high resistance material with an electrical resistivity of about log ^{10 10} ohm-cm or higher to contain the electric field generated by the circuit. Accordingly, the medical device 10 will preferably not produce any electromagnetic interference or electrostatic discharge.

  A thermally conductive probe 60 (FIGS. 2A / B and 3A / B) extends outwardly from the insulating jacket 50 and is thermally coupled to the self-controlling electrical heating element 20. The probe 60 has a circular cross-section 62, a square cross-section 64, an oval, a rectangular or other elliptical cross-section, a lip tip 66, or possibly a rotating ball tip, blunt tip, sharp or other piercing tip 68. May have any of several shapes, including those further adapted to supply heated fluid by the device for application on or injection into the target tissue A hollow tube can be formed. The probe can also have more than one needle or can be divided into multiple as forked probes. Similarly, the probe may accompany or include cutting, suturing, or stapling capabilities, and thus among several well-known operable medical tools, such as those used in arthroscopic surgery Can be formed provided that they are thermally conductive in order to receive and transfer heat from the heater elements of the device. For example, the probe tip may include a tool for delivering preheated biodegradable staples or other materials to the target tissue. The preheated material delivered by such a tool can be used to cauterize blood vessels or to ablate nerves or other tissues.

  Probe 60 is attached to self-controlling electric heating element 20, insulation jacket 50, or electric spacer 70 by pins, screws, ratchets, spring clamps, magnets, connectors, or other attachment means (see FIG. 1). 4) can be part of a replaceable module. FIG. 4 depicts a pin 63 that can be attached to the core 70. In any case, the probe support 61 is reversibly connected to the medical heating device, and various types of probes can be fitted using the same support 61. The support 61 provides the ability to quickly snap and release different probes to perform medical procedures more effectively. Probe interchangeability provides great flexibility in the usefulness of certain heating devices. Given the similar heating requirements, different medical applications can be performed using the same tool, simply by exchanging one probe module for another.

  The probe 60 is positioned relative to the probe 60 and can be coupled to a suitable display through a plug assembly to assist the user in directing the probe to the target location, such as a fiber optic imager. It may include or support at least one sensor 66. Any such imaging sensor or scope may comprise an antifogging device or agent. The heat from the self-controlling electric heating element 20 can be used in combination with such antifogging devices or agents. The sensor 66 can also be a nerve detector. Such neural detectors are well known and are used in other probe-like medical tools. As with the imager, they can preferably be located in the vicinity of the probe 60, or even integrated into the heated probe itself for more fine control of positioning.

  The electrical wire circuit connection 40 may create a circuit connection between the self-controlling electrical heating element 20 and the power supply 30. The electricity can be a standard 110 VAC, AC battery, DC battery, solar cell, or a custom power module, itself powered by any of the foregoing. The exemplary power supply 30 (FIG. 1A) typically includes circuitry that delivers other powers of RF to the device 10 and receives signals from the sensor 66. The power supply 30 is connected by a cable 40 and a removable plug 45. In FIG. 1C, the power source and electrical wire circuit connections are completely contained inside the insulation jacket 50. Accordingly, the medical heating device 10 has a “wireless mode” (ie, no external wired connector), as depicted in FIG. 1C.

  The medical heating device 10 may further include an on / off switch 80 that may be located on the thermal jacket 50, close to the user's hand when the device is in operation (FIGS. 1A-1C). The on / off switch switches the electrical circuit connection 40 from the power supply 30 on and off, thereby cutting off power to the self-controlled heater 20.

  The medical heating device 10 includes ultrasonic, monopolar electrosurgery, bipolar electrosurgery, aspiration, expansion, inhalation, microelectronic chip, optical fiber, radio frequency, microwave, infrared, X-ray, laser, light emitting diode, It can be used in conjunction with other medical devices, such as resistance or wire heating, or other standard medical devices that can be placed on or near the probe 60. Electrosurgery is the application of high frequency current to biological tissue as a means to cut, coagulate, dry, or discharge treat tissue. In an electrosurgical procedure, tissue is heated by an electric current passing through itself. The effect includes the ability to make precision cuts with limited blood loss. Electrosurgical devices are often used during surgery to prevent blood loss in a hospital operating room or outpatient procedure.

  The medical heating device 10 constructed in accordance with the present invention is used by contacting the distal end (eg, sensor 66) of the probe 60 to the target tissue, whether on the patient's skin surface, subcutaneously, or deep. obtain. If the target tissue is skin, the maintenance temperature of the device may be selected such that it does not exceed 45 ° C (113 ° F). At such moderate temperatures, heat transfer from the probe to the skin can produce skin tightening, skin surface reconstruction, and collagen remodeling for dermal regeneration and cosmetic applications. This can also be achieved by mechanical excision of skin surface cells. Alternatively, higher temperatures can be used to cut the skin while simultaneously cauterizing any bleeding.

  If the target tissue is subcutaneous lipid (adipose) tissue, heat transfer through a puncture probe inserted into the skin can be used to cause selective damage to fat cells proximate to the probe end. . If the target tissue is nerve tissue, a trigeminal branch that is a branch of the facial or horn nerve temporal branch that uses heat transfer from the probe to provide innervation to the facial eyebrows and nasal root muscles Selected nerves such as nerves (eg, for the treatment of migraine) can be excised. This can assist in the removal of the lashes between the eyebrows.

  The target tissue can be a gland sweat gland that treats hyperhidrosis, or a gland such as in the oral tonsils when performing a tonsillectomy or partial excision.

  The target tissue can be a blood vessel (vein, artery, capillary, blood) and heat transfer through the probe can be used to produce local blood clotting and cauterization of the vascular tissue. Alternatively, at lower temperatures (body temperature of about 37 ° C.), the hollow probe can inject preheated fluid into the target artery or vein, for example, for local drug delivery.

  The target tissue can be some abnormal growth, polyp, or tumor, such as the sinus or oral cavity. Here, heat transfer through the probe can ablate the tissue. Examples include mucosal lesions found in Barrett's esophagus, or nasal hypertrophy-derived tissue growth, or removal of colon or rectal polyps.

  A heated medical device also applies heat to selected nerves or muscle tissue, for example by excising sensory nerves or stimulating blood flow in muscle pain, thereby providing a part of a pain management or treatment protocol. As part, it can be used.

  A medical device constructed with self-controlling electric heater elements according to the present invention can be a replacement for current electric arc-based devices used for similar purposes. Any medical application that requires controlled heat delivery to a selected target tissue can employ the present invention with excellent control and safety. The present invention can be used in medical, dental, and veterinary procedures.

  Currently, the preferred material for a self-regulating electric heater is a combination of one or more NTC materials and one or more ZTC materials with a resistance versus temperature response curve similar to that shown in FIG. 9C. . Suitable materials include NTC thermistor 3, MF51, MF52, and CWF commercially available from Cantherm (Montreal, Canada), and various materials commercially available from General Electric (Fairfield, Connecticut, USA).

  Referring to FIGS. 11-18, there is a power source 97 that generates an electric field between at least two conductive sections (conductive sections) 225 of the set. The power source 97 may generate an electric field directly between the conductive sections 225, or alternatively, indirectly power the electric field generator 100 and, in turn, generate an electric field between the conductive sections 225. The power source 97 can be a direct current or an alternating current power source. In the case of a direct current power source 97, the electric field generator 100 will need to produce an alternating current or alternating polarity electric field in the target tissue 250. Illustrated because there are many standard sizes of such batteries that are small in size but also capable of powering a special electric field generator device capable of producing a suitable electric field that results in the desired precise cell injury The general power source 97 is a direct current battery.

  In contrast to direct current, alternating current is preferred in this situation because it can produce more heat per amp than direct current. It is believed that there is a specific resonance or spike frequency at which heat production is maximized from the alternating current that flows across the specific type of target tissue 250. At this frequency, current passes through the target tissue 250 with the least resistance. Thus, at a particular resonance frequency of a particular target cell, less power is required to produce equivalent or better heat within that cell. Thus, alternating current is preferred because it reduces the power requirements of the device, thereby enabling it to be small enough to make the device portable. The resonance frequency of the nerve cell and its surrounding tissue is 460 KHz and is therefore a preferred frequency. Electrosurgical devices generally operate at this frequency because this frequency is considered to be the resonant frequency of many types of tissue as well as neural tissue.

  The electric field generator 100 comprises a pulse width modulated power supply that is electrically connected to common circuit board components, including resistors, capacitors, diodes, and switches. The electric field generator 100 may further comprise a transformer 175 (FIG. 12), and the output signal from the pulse width modulated power supply is the primary connection with the converter. The electric field generator 100 typically has a specific frequency and power in order to function properly with a specific probe / expansion 200 of the device 91 according to the requirements for providing a specific desired precision cell injury. Custom designed to generate a specific alternating polarity field. The exemplary electric field generator 100 uses three needle probes 200 to produce a suitable output for nerve cells, where the generator was similarly designed to be very small. The electric field generator 100 includes a pulse width modulated power supply and circuit board components assembled on a custom circuit board, and inside a typical pen shape and size enclosure, as depicted in FIGS. 14-16. It has a generally long and narrow shape, such as a rectangle, that can be adapted. Alternatively, the electric field generator 100 may consist of a number of electrical circuit boards that are electrically connected by relaxation wires to fit inside a variety of differently shaped enclosures. The electric field generator 100 includes a donut-shaped transformer 175 electrically connected to the distal end of the custom circuit board at the distal end inside the donut hole of the transformer 175, and the auxiliary voltage from the transformer 175 And current is passed through the target tissue 250.

  The mode pulse width modulated power supply comprises at least six electrical connections, namely two power input connections consisting of positive and negative power connections 101 and 103, two signal output connections 105 and 107, and two trimmer input connections 109. And 111. The output signals 105 and 107 generate an electric field in the target tissue located between the conductive sections 225 when the alternating polarity is rapidly changed to generate or induce an alternating current in the target tissue. Tissue contains water and other conductive molecules and generates an electric current in response to an electric field, causing an electric current to be generated or induced. Output signals 105 and 107 are electrically processed through a custom circuit board prior to being electrically connected to conductive section 225. The frequency of the alternating polarity of the electric field substantially matches that of the alternating current generated thereby. Alternatively, outputs 105 and 107 can be electrically connected to a primary input on transformer 175, in which case the secondary outputs of transformer 175 are 105a and 107a. The transformer 175 stabilizes the resonant frequency for the target tissue, filters the switching noise from the generator 100, and operates the generator 100 at a more efficient frequency than the resonant 460 KHz for neural tissue, thereby allowing the battery of device 91 to operate. Can be used to help extend lifespan. Further, the electrically processed signal from 105, 105a, 107, or 107a may be looped back to the control unit 125, as described below, where the signal is further processed and input 109 on the electric field generator 100. And returned to 111.

  The electric field generator 100 preferably detects the target nerve prior to heat production and from the signal output 105 or 107 into the target tissue 250 to provide a precise location of the high frequency alternating current medical device. One or more direct current pulses can be emitted. Before the surgeon delivers an alternating electric field that heats the target tissue 250, the surgeon can use one or more direct current pulses to locate the precise target nerve cell or component thereof. . The direct current pulses can be of various amplitudes and waveforms, and optionally multiple shaped pulses can be emitted from the electric field generator 100 simultaneously. By positioning at least two conductive segments on or in the area of the target cell, the pulses emitted from the conductive segments stimulate the muscles that the nerve drives, thereby causing the muscles to convulse or in some way move. Accordingly, by moving the probe 200 and the conductive segment 225, the target nerve can be located before delivering the therapeutic current to be denervated. A search is performed until the targeted muscles are convulsed, or otherwise accurate movement is indicated, at which point the surgeon has identified the correct nerve cell or component thereof and has at least 2 One knows that the two conductive segments are now precisely located on the correct target tissue 250. Thus, it is known that at least two conductive sections are accurately located by accurately detecting and identifying the precise location of high frequency alternating current delivery to achieve ablation of neural tissue The high frequency alternating current medical device 91 can be positioned very precisely and accurately. Then, at this point, the surgeon may activate the alternating current field to produce accurate target tissue heating, in which case no other tissue is heated.

  The electric field generator 100 is preferably small and small so that it can be easily held by an average adult with one hand. For example, a standard 9 volt battery can be used to power the exemplary electric field generator 100 to achieve the desired cytotoxicity.

  Optionally, the high frequency alternating current medical device 91 has two probes or needle projections 200 and the electric field generated by the generator 100 will be single phase. A block diagram for this mode is depicted in FIG. One probe or needle projection 200 includes one conductive section 225 that is electrically connected to a contact 107 on the electric field generator 100, and the other probe or needle projection 200 is on the electric field generator 100. Other sections 225 that are electrically connected to the other contacts 105 will be included. Alternatively, the high frequency alternating current medical device 91 has a single probe or needle projection 200 and the electric field generated by 100 will be single phase. A block diagram for this mode of operation is depicted in FIG. 11A. A single probe or needle projection 200 will include both sections 225. Still, in other embodiments, the device 91 has more protrusions 200, so the electric field generator 100 is more electrically connected to one probe or needle protrusion 200, respectively. In order to take advantage of this, it will be necessary to have at least an equal number of signal outputs. For example, each protrusion may emit one of many phase signals, or one of many common signals produced by the generator, so that device 91 can be a very specific desired precise cell. To assist in causing injury, many probes or needle-shaped protrusions 200 can be provided to generate complex electric field combinations. Device 91 may alternatively have a number of probe or needle projections 200 with only two signal outputs 105 and 107, with the 105 and 107 signals possibly along a row or arc of projections 200. Then, it is connected to many protrusions in an alternating manner. Since current is generated between each protrusion 200 in this manner, in this manner, by alternating only two signals, large lesion sites along a row or arc from only a single-phase alternating electric field are generated. Can be generated.

  The exemplary high frequency alternating current medical device 10 has three needle-shaped protrusions arranged in a straight line. See FIGS. 15 and 16. The central protrusion 200 is electrically connected to the electric field generator 100 by a common signal conducting wire 107a. The two outer protrusions are electrically connected in parallel to the electric field generator 100 by a single-phase signal conductor 105a. A block diagram for the devices of FIGS. 15 and 16 is depicted in FIG. In all configurations and modes, the phase signal passes through the self-regulating conductive material electrical component 150 before entering the target tissue.

  At least one probe or needle projection 200 may be removably attachable to the rest of the circuitry and structure of the high frequency alternating current medical device 91. In addition, at least one or more needle-shaped protrusions 98 that can be removably attached to a wide range of different types, sizes, shapes, materials, etc. that can be removably attached to the rest of the high frequency alternating current medical device. , 200 may be present (FIGS. 14-16). Thus, the present invention includes a series of removably attachable tips 98, each tip 98 comprising at least one needle of the protrusion 200 and at least two conductive sections 225 located thereon, Each mounted on a medical device is electrically connected to the rest of the device according to the circuit diagrams of FIGS. 11-12. The needle penetrates beneath the patient's skin surface, accesses and engages nerves or other target structures under the skin, and is thus adapted to deliver heat, RF, or other energy to such structures. The

  One such removable attachable tip 98 'can be another neurodetector with two small conductive electrodes or pads 99 at its distal end. Two small pads are used to electrically contact the target tissue surface with the electric field generator 100. Thus, a “neural detector” tip 98 ′ can be used to find the nerve first, and then once the location is specified, a separate treatment tip 98 is attached to the device 91 to heat the nerve. Will.

  The removably attachable tip 98 typically has a generally conical or cup shape with an opening at the wide end of the cone and is flat at the narrow end of the cone to form a generally cup shape. The at least one needle-shaped protrusion 200 is attached to the outer surface of the narrow end of the cone or the bottom surface of the cup. The distal end of the high frequency alternating current medical device 91 with the tip 98 removed may also have a generally conical or cup shape, the device cone being slightly smaller than the tip cone. Accordingly, the concave tapered section of the tip 98 is then slid over the convex tapered section of the device cone so that the tip 98 fits snugly over the device cone. Further, optionally, a clasp means, a snap-fit means, a locking means to hold the tip 98 on the device cone so that the surgery is very stable and safe so that it can be performed by a surgeon. There may be a locking mechanism, such as, or similar fasteners. The securing mechanism will also have release means so that the removably attachable tip 98 can be removed. Thus, the fastener means, snap-fit means, locking means, or the like will have the ability to release the means for removing the tip 98. For example, in the case of a snap-fit means, the tip cone can be squeezed with a finger to cause the tip cone to deform, thereby releasing one or more snap-fit points between the tip cone and the device cone. It can be made of a flexible property. When the tip 98 is snapped into place on the device 91, an electrical connection is made between the at least two conductive sections 225 and the generator signals 105 or 105a and 107 or 107a. The removable attachable tip 98 can be supplied in a sterilized state and then discarded after use.

  The operating frequency of the pulse width modulation is provided by the electric field generator 100 (FIG. 12) to within about 5% using either the trimmer input connection 109 or 111. Trimmer input connections 109 and 111 are electrically connected to a control module 125 that is powered by battery 97 and electrically connected to electric field generator 100. The control module 125 includes one or more trimmer resistors or similarly functioning electronic components that are electrically connected to a frequency modulation control switch 127, which manually adjusts the frequency of the signal 105. It is a setting switch on the control unit 125 that is used to adjust in.

  The control module 125 also automatically adjusts and stabilizes the frequency of the signal generated by 100 by sampling the signal 105 and electrically processing it to determine if the frequency is optimal. Can be configured to. The signal and current from 105 are electrically filtered, processed, and analyzed, and the result provides a signal input for adjusting the trimmer input 109 or 111. Thus, the control module 125 generates a feedback circuit from the signal output 105 to the trimmer input 109, providing automatic fine tuning and stabilization of the output. For more than one output phase signal, a feedback circuit may need to be generated for each output phase to automatically adjust and stabilize the frequency of all phases. The control unit 125 optionally and also determines whether the current through the target tissue exceeds a certain maximum preset limit, and if the current exceeds this limit, interrupts the electric field generation. This is a current interrupt setting 129 that allows the surgeon or technician to set the maximum current level, and when the device 10 exceeds this level, it interrupts its electric field generation.

  At least two electrical outputs are used to perform the surgery, namely phase signal 105 and common signal 107. The output can be filtered, converted, and otherwise electrically processed through standard circuit board components, resulting in the desired precision cell injury. The phase signal 105 passes through the self-controlled conductive material electrical component 150 and onto the target tissue 250. It then proceeds through the target tissue 250 and returns to the electric field generator 100 through the common signal 107.

  Self-regulating conductive material electrical component 150 regulates the current through target tissue 250. As described above in connection with the first embodiment, the self-regulating conductive material electrical component 150 functions electrically, such as a thermistor, thermocouple, or switch.

  If the preferred example of self-regulating conductive material electrical component 150 is a switch, the alternating current in the target tissue is completely blocked by 150 for a short time until the target tissue is sufficiently cooled. Thereby avoiding unnecessary cell damage, and then the switch 150 switches the alternating current in the target tissue again, thereby heating it again for a short time, eventually turning it off again, Will be repeated. This process essentially repeats several times per second, resulting in an overall steady state temperature in the target tissue.

  If an example of a self-regulating conductive material electrical component 150 acts like a thermistor or thermocouple, a temperature change of 150 will not lead to a sudden off / on switching of alternating current in the target tissue. In order to control the temperature of the target tissue and surrounding tissue, a gradual heat increase or decrease is provided, as described below. The thermistor has the most gradual AC current variation.

  Self-controlling conductive material electrical component 150 consists essentially of a homogeneous mixture of different materials, including substrate and conductor dopants. The self-controlled conductive material electrical component 150 has a special combination of substrate and dopant that varies with its temperature, the resistance of the self-controlled conductive material electrical component. Impact of electrons, ions, or other charged particles that occur inside 150 as a result of alternating current passing through target tissue 250 as current passes through self-controlling conductive material electrical component 150 Heat is generated in the self-controlling conductive material electrical component 150. Thus, the increase in current through the target tissue 250 results in increased heat production within the self-regulating conductive material electrical component 150. This heat causes structural changes in the intimately mixed molecules of the material and, in turn, changes in the conductivity of the self-controlled conducting material electrical component. For example, in the case of some self-regulating conductive materials or thermistors, heat expands the substrate, which causes the conductive dopant suspended therein to be separated, thereby causing the current passing therethrough. Reduce and eventually block. In other self-regulating conductive materials or thermistors, temperature changes cause a phase change in the substrate or dopant material, which causes a structural change at the molecular level, from conductive to non-conductive or vice versa. The effect of switching to.

  In any case, to provide the best mathematical properties between temperature and resistance, and to provide the best surgical performance, i.e., the temperature range required to produce the desired precise cell injury, Special care must be taken to select / design the best self-controlling conductive material electrical component 150. The relationship between the temperature and conductivity of self-controlling conductive material electrical components is typically non-linear, so we use a logarithmic scale to describe the thermistor characteristics. Conductivity is typically measured by its reciprocal, which is resistivity.

In a preferred embodiment, the self-controlled conductive material electrical component 150 is made of a PTC material. FIG. 7 is a graph of electrical resistivity versus temperature for a PTC heater material suitable for our purposes. The suitability for a typical procedure requires a resistivity that gradually increases with temperature, as seen by the positive slope characteristic of the intermediate level of the graph. Furthermore, at T ₀ there is an inflection point in the graph. As the temperature rises above T ₀ , the resistivity increases at a slower rate with temperature. Thus, as the temperature rises above T ₀ , there is a gradual decrease while the current passing through the target tissue is decelerating. As the temperature drops below T ₀ , the resistivity decreases with deceleration with decreasing temperature. Therefore, the temperature is, as the drops below the T _0, there is a gradual increase while decelerating the current passing through the target tissue. Referring to FIG. 7, from T ₀ to T _H, the resistivity gradually increased, thereby reducing the heat production in the target tissue. Similarly, from T ₀ to T _L , the resistivity gradually decreases, thereby increasing heat production in the target tissue. At T ₀ there is another mathematically stable temperature point, otherwise known as an inflection point. Materials with this inflection point relationship are preferred because they provide optimal stability or self-controlled conducting material electrical components at T ₀ , thereby producing a stable alternating current in the target region.

  The temperature of the self-controlled conductive material electrical component 150 determines the current passing through the target area. Thus, an important design criterion for the high frequency alternating current medical device 91 is that the minimum current required to produce the desired precise cell injury, then which self-regulating conductive material electrical component is mathematically balanced. Determining the best self-regulating conductive material electrical component for high frequency alternating current medical device applications.

Different precise cytotoxic procedures may require different cell heating or current operating ranges. For example, different procedures require different shaped and sized probes of the needle projection 200, thereby changing the current requirements, and thereby the self-regulating conductive material electrical component requirements of the high frequency alternating current medical device 91. Can be changed. Different target tissues require different currents or heating, and can thereby do so. Thus, certain procedures may require different self-regulating conductive material electrical components with different target temperatures T ₀ with different operating ranges T _H to T _L. These criteria can be adjusted by carefully selecting PTC, NTC, or ZTC thermistor materials for the high frequency alternating current medical device 91. In addition, different dopants and different concentrations of dopants can be used to vary the properties and produce different resistance temperature graphs. Additional combinations of PTC, NTC, and ZTC materials can be used to provide different resistance temperature graphs.

FIG. 9A includes the resistance temperature relationship of the NTC material. This arrangement can be used to produce a maximum operating current, determined by temperature T ₀ , with a sudden break in current above it. FIG. 9B includes the resistance temperature relationship of the ZTC material. This arrangement can be used to generate a constant current over the target area at a certain level ranging from temperatures _TH to _TL . FIG. 9C includes the resistance temperature relationship of NTC / ZTC material. This arrangement can be used to produce a wide operating current range that is correlated with a constant current at a certain level with a sudden cut-off at temperature T _L and that from T _H to T _L. FIG. 9D includes the resistance temperature relationship of the PTC / ZTC material. This arrangement is correlated with that of T _L from a constant current and T _H in a certain level due to the rapid increase in current at the temperature T _L, it is used to produce a wide range of operating current, thereby at a certain temperature, Target tissue may be prevented.

PTC, NTC, and ZTC materials can consist of crystalline or semi-crystalline polymer-based materials with the addition of certain conductive “doping” materials. For polymer-based thermistors, the transition temperature results from the melting or freezing of the polymer molecules. In the case of crystalline or semi-crystalline polymers, the molecular structure is packed more tightly in the solid phase and less tightly packed in the amorphous or elastomeric phase. Polymer molecules are generally non-conductive, and therefore a conductive dopant must be added to make the material conductive. At temperatures below T ₀ , most polymer molecules are in the solid phase and are therefore tightly packed and therefore in their most conductive state or level. At temperatures above T ₀ , most polymer molecules are in the amorphous or elastomeric phase and are therefore less densely packed and therefore in their least conductive state or level. For the same choice of matrix polymer, the transition temperature T ₀ is generally consistent with the polymer softening point of the selected matrix polymer.

  The dopant material is added to the substrate to make it conductive so that it functions like a heating element. The dopant is also added to slow down the resistance change or to enlarge the above graph. The dopant is a conductive material such as carbon black, metal oxide, semiconductor material, mixtures thereof, or other material that is conductive and can be produced in small particles. Specific resistance-temperature relationships for PTC, NTC, and ZTC materials are achieved by varying the dopant type and concentration. Thus, reducing the concentration or density of conductive particles within a polymer-based composition is one way to obtain the desired gradual resistance change for a self-regulating heater element. In general, a dopant level above 50% results in a switched material, a 15-40% dopant level results in a thermistor material, and a 10% dopant level results in electromagnetic interference and / or electrostatic discharge. Also, the porosity, surface area, particle size, and oxygen content of the conductive dopant can be varied to produce various properties. Also, more than one type of dopant can be added to the substrate. Either the substrate molecule or the dopant material particles can actually cause heating in the thermistor. Thus, the dopant can function to produce electron transfer, or vibrational heating, or both. All of these factors, along with various carbon black loading levels and others, along with the type of substrate, result in a nearly infinite combination between the type and amount of dose, resulting in a nearly infinite specific resistance temperature relationship. .

PTC, NTC, and ZTC materials can also consist of ceramic materials or ceramic-based materials with added conductive dopants. The ceramic material can be conductive or non-conductive depending on the conductive phase or structure. The ceramic material can be designed to change phase from solid to elastomer or from elastomer to solid at a particular temperature T ₀ . Typically, the ceramic-based material is barium titanate and / or related divalent titanate and zirconate. Typical dopants include lead, strontium, rare earth metals, antimony, bismuth, or the like. Dopants are added to increase or decrease the substrate's exceptional range, or to further adjust the resistance temperature related slope. Various ceramic thermistor heaters are commercially available with different temperature resistivity relationships. Also, ceramic thermistor heater material manufacturers may attempt to launch special development programs that specifically deliver the desired properties.

  In some modes, a conventional switch is added to the tissue heating circuit or circuits, or a conventional thermocouple is placed in the vicinity of the conductive section 225, or both are performed to target tissue The 250 temperature control is further improved, or an additional layer of safe current interrupt control or the like is added during the electric field generation mode or surgical mode.

  The high-frequency alternating current medical device 91 (FIG. 13) typically includes a main power on / off switch 93, an electric field on / off switch 94, a main power indicator lamp 95, and an electric field indicator lamp 96. A user interface 92 is included. The user interface 92 is electrically connected to the control module 125 (FIG. 12), sends and receives signals therefrom, and is indirectly powered by the battery 97 through the control module 125 electrical connection. The main power switch 93 engages power to the electric field generator input and control module 125. When the switch 93 is turned on, the power indicator lamp 95 is illuminated. Surgery can be performed when an electric field controlled by an electric field on / off switch 94 is generated. When switch 94 is activated, an electric field is engaged between at least one probe or needle projection 200. The electric field indicator 96 illuminates when the electric field on / off switch 94 is engaged.

  As mentioned above, the high frequency alternating current medical device 91 is preferably a single device powered by a portable battery. To facilitate this, all components are assembled on one small circuit board. In this configuration, the switches 93 and 94 may be located outside the high frequency alternating current medical device 91 and in proximity to the surgeon's index finger holding the high frequency alternating current medical device 91. The lamps 95 and 96 may also be located outside the high frequency alternating current medical device 91. The frequency modulation setting 111 and the cutoff setting (FIG. 12) are typically set differently for a procedure and need not be adjusted during the procedure, and thus may be located inside the device 91.

  In order to provide the most comfortable and logical instrument for the surgeon, the high frequency alternating current medical device 91 is preferably shaped like a pen. The elaborate nature of producing the desired precise cell injury requires subtle hand movements similar to writing on very small prints. Thus, a surgeon who is comfortable writing with a pen is also comfortable using the high frequency alternating current medical device 91, resulting in the desired precision cell injury.

  The at least one probe or needle projection 200 typically has an outer diameter of 0.5 to 0.7 millimeters and a length of 5 millimeters to the tissue puncture distal end. The surface of the at least one probe or needle projection 200 is a non-conductive surface and therefore does not emit an electric field except for the section 225 with the probe or needle projection 200. Only in section 225 will an electric field be emitted therefrom.

  As previously mentioned, at least two conductive sections 225 are required to generate a current in the target tissue. In two embodiments of the high frequency alternating current medical device 91, at least two conductive sections 225 are both located on one probe or needle projection 200, or one section 225 has two needle protrusions. Located on each of the 200. Conductive section 225 may have a layer or coating, or alternatively may not have a layer or coating that makes section 225 conductive. For example, the needle can be made of a non-conductive material, in which case the conductive section is formed by one or more conductive coatings thereon. The needle can be made of a conductive material with a non-conductive coating on the surface, except for the conductive section 225. Any assembly of conductive and non-conductive materials can be used to provide a needle / probe with an effective conductive section 225. Section 225 is electrically connected to signal 105 or 107. When section 225 is located at the distal end of probe or needle projection 200, heat is produced only below the surface of the tissue, thereby also preventing the desired precise cell without damaging the surface of the tissue. Provides far more opportunities to cause injury. Section 225 is preferably located at the distal end of needle projection 200 and is approximately 1-4 millimeters in length.

  The method of using the high frequency alternating current medical device 91 includes the steps of picking up the high frequency alternating current medical device 91, turning on the high frequency alternating current medical device, and placing at least one probe or needle-shaped protrusion 200 on the target tissue 250. Contacting at least one probe or needle projection 200 below the surface of the target tissue 250, or inserting at least one probe or needle projection 200 into the body cavity 250; Exciting the electric field generator 100 thereby inducing or generating an electrical alternating current in the target tissue 250; releasing the electric field generator 100; and at least one probe or needle projection from the target tissue 250. Removing 200 and any desired desired To generate accurate cytotoxicity, if necessary, and a step of repeating the steps above. Optionally, the low power dc current can be used to identify the nerve of interest prior to delivery of the alternative current.

  A high frequency alternating current medical device constructed in accordance with the present invention is used by contacting at least one probe or needle projection 200 to a target tissue 250, whether on the skin surface, subcutaneous, or deeper of a patient. obtain. When the target tissue is skin or subcutaneous tissue, a particular type of probe and temperature can be selected to achieve skin tightening, skin surface reconstitution, and collagen remodeling. The maintenance temperature of the device may be selected such that it does not exceed 41 ° C. (106 ° F.). At such moderate temperatures, 200 can produce skin tightening, skin surface reconstitution, and collagen remodeling for dermal regeneration and cosmetic applications. This can also be achieved by mechanical excision of skin surface cells. Alternatively, higher temperatures can be used to cut the skin while simultaneously cauterizing any bleeding.

  If the target tissue is subcutaneous lipid (adipose) tissue, the tissue is such that at least one probe 200 is inserted percutaneously into the skin and causes selective damage to adipocytes proximate the ends of the 200. It must have a puncture structure.

  The target tissue can be any of the aforementioned tissues in connection with the first embodiment. The second embodiment is particularly suitable for identifying and treating nerves.

  The target tissue can be any organ system in the body, such as heart, lung, brain, eye, kidney, liver, ovary, thyroid, bladder, uterus, stomach, intestine, cecum, gallbladder, or the like.

Claims (9)

A medical heating device,
A portable enclosure;
A power source in the enclosure;
A thermally conductive probe extending from an end of the enclosure, the probe having a tissue contacting distal end and a proximal end;
A temperature coefficient of change (TCC) element comprising a PTC element that forms a heater having a resistance change in the range of 2 to 4 in response to a temperature change in the range of 20 ° C. to 80 ° C. A TCC element is located within the enclosure, and the power source comprises a TCC element that provides power to the TCC element;
The thermally conductive probe is coupled to the TCC element and transfers heat from the TCC element to the tissue contacting distal end;
The proximal end is connected to the TCC element;
The TCC element has a physical form of at least one coil wound around a core electrical spacer, the core electrical spacer electrically separating several regions, but other than the TCC element A medical heating device that functions to electrically connect a region of the power source to the power source and to provide a current path through the length of the at least one coil. The PTC element whose resistance changes in response to a temperature rise is:
Comprising a thermistor heater material, the thermistor heater material comprising a polymer-based material with 5-40% conductive dopant material and 5-40% conductive dopant material in a ceramic material without dopant material Wherein the thermistor heater material is characterized by an electrical resistance that varies with temperature, wherein the variation causes a variation in heat production from the element, the TCC element further comprising: The medical heating device of claim 1 comprising an NTC element or a ZTC element.   The medical heating device according to claim 1, wherein the power source is a direct current battery.   The medical heating device according to claim 1, wherein the enclosure includes a heat insulating jacket.   The medical heating device according to claim 1, wherein the thermally conductive probe comprises one or more needle-shaped probes.   The medical heating device of claim 1, wherein the thermally conductive probe comprises at least one hollow tube adapted to deliver or remove material from a target tissue. The medical heating device of claim 6 , wherein the thermally conductive probe has a cross-sectional shape that is circular, elliptical, square, or rectangular. The medical heating device of claim 6 , wherein the thermally conductive probe has a distal end that is a lip, rotating ball, puncture, sharp, or blunt. The medical heating device according to claim 1,
The medical heating device delivers heat to a tissue location;
The power source generates a current configured to be passed through the TCC element from the power source such that the TCC element heats;
A tissue contacting distal end of the thermally conductive probe is configured to be engaged against the tissue location;
Heat is delivered to the tissue, causing the probe to cool, which causes the TCC element to cool, causing a temperature change that changes the resistance and returns the temperature of the TCC element to a control point. Medical heating device.

Images