USRE42835E1 - Apparatus and method for reducing subcutaneous fat deposits by electroporation with improved comfort of patients - Google Patents
Apparatus and method for reducing subcutaneous fat deposits by electroporation with improved comfort of patients Download PDFInfo
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- USRE42835E1 USRE42835E1 US12/571,974 US57197409A USRE42835E US RE42835 E1 USRE42835 E1 US RE42835E1 US 57197409 A US57197409 A US 57197409A US RE42835 E USRE42835 E US RE42835E
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/327—Applying electric currents by contact electrodes alternating or intermittent currents for enhancing the absorption properties of tissue, e.g. by electroporation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0408—Use-related aspects
- A61N1/0412—Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0408—Use-related aspects
- A61N1/0412—Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
- A61N1/0416—Anode and cathode
- A61N1/0424—Shape of the electrode
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/328—Applying electric currents by contact electrodes alternating or intermittent currents for improving the appearance of the skin, e.g. facial toning or wrinkle treatment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36014—External stimulators, e.g. with patch electrodes
- A61N1/36021—External stimulators, e.g. with patch electrodes for treatment of pain
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0408—Use-related aspects
- A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
Definitions
- the present invention relates generally to electroporation in-vivo and specifically to apparatus and method for reducing subcutaneous fat deposits and/or for performing virtual face lifts and/or body sculpturing.
- “Cosmetic surgery” is a phrase used to describe broadly surgical changes made to a human body with the usual, though not always, justification of enhancing appearance. This area of medical practice constitutes an ever-growing industry around the world. Obviously, where such a procedure fails to deliver an enhanced appearance, the procedure fails to meet the desired goal.
- One of the reasons that the majority of current procedures fail to deliver upon their promise is that, for the most part, current procedures are invasive, requiring incisions and suturing, and can have serious and unpleasant side effects, including but not limited to scarring, infection, and loss of sensation.
- a face-lift is intended to enhance facial appearance by removing excess facial skin and tightening the remaining skin, thus removing wrinkles.
- a face-lift is traditionally performed by cutting and removing portions of the skin and underlying tissues on the face and neck. Two incisions are made around the ears and the skin on the face and neck is separated from the subcutaneous tissues. The skin is stretched, excess tissue and skin are removed by cutting with a scissors or scalpel, and the skin is pulled back and sutured around the ears. The tissue tightening occurs after healing of the incisions because less skin covers the same area of the face and neck and also because of the scars formed on the injured areas are contracting during the healing process.
- Another laser procedure involves using optical fibers for irradiation of the subcutaneous tissues, such as disclosed in U.S. Pat. No. Re36,903.
- This procedure is invasive and requires multiple surgical incisions for introduction of the optical fibers under the skin.
- the fibers deliver pulsed optical radiation that destroys the subcutaneous tissues as the tip of the fiber moves along predetermined lines on the face or neck.
- Debulking the subcutaneous fat and limited injury to the dermis along the multiple lines of the laser treatment results in contraction of the skin during the healing process, ultimately providing the face lift.
- the drawback of the method is its high price and possibility of infection.
- Electrosurgical devices and methods utilizing high frequency electrical energy to treat a patient's skin including resurfacing procedures and removal of pigmentation, scars, tattoos and hairs have been developed lately, such as disclosed in U.S. Pat. No. 6,264,652.
- the principle drawback of this technology is collateral damage to the surrounding and underlying tissues, which can lead to forming scars and skin discoloration.
- liposuction is an invasive procedure that involves inserting a suction device under the skin and removing fat tissues.
- a suction device that involves inserting a suction device under the skin and removing fat tissues.
- this procedure has resulted in patient deaths when too much tissue was removed. Assuming successful removal of excess fat tissue, further invasive surgery may be required to accomplish desired skin tightening.
- E electropultation
- Living cells include a biological membrane, also commonly called a cell wall, that separates the inner volume of a cell, or cytosol, from the extracellular space, which is filled with lymph.
- This membrane performs several important functions, not the least of which is maintaining gradients of concentration of essential metabolic agents across the membrane. This task is performed by active protein transporters, built in the membrane and providing transport of the metabolites via controlled openings in the membrane.
- the active protein transporters, or pumps routinely providing transport of various metabolic agents, especially proteins, across membranes, use the energy of hydrogen or sodium positive ions passing from a positive potential of the intracellular space to a negative potential of the cytosol, or for the opposite direction the energy of a negative chlorine ion.
- This energy supply is provided by maintaining the potential difference across the membrane which, in turn, is linked to the difference in concentrations of sodium and potassium ions across the membrane. When this potential difference is too low, thousands of the active transporters find themselves out of power.
- electroporation of the cell may result in significant metabolic or structural injury of the cell and/or its death.
- the cause of cell death after electroporation is believed to be an irreversible chemical imbalance and structural damage resulted from the fluid communication of the cytosol and the extracellular environment.
- the survivability of electroporated cells is limited. As the electric field amplitude and/or duration of pulses, increases, this limit, usually referred to as the “upper EP limit” of electroporation, is inevitably achieved. Above the upper EP limit, the number and sizes of pores in the cellular membrane become too large for a cell to survive. Multiple pulses cause approximately the same effect on the cells as one pulse with duration equal to the total duration of all applied pulses. After application of an electrical pulse above the upper electroporation limit the cell cannot repair itself by any spontaneous or biological process and dies.
- the upper EP limit is defined by the combinations of the amplitudes of electric field and pulse durations that cause cellular death.
- the vulnerability of cells to electroporation depends on their size: the larger the cell, the lower the electric field and duration of a pulse capable of killing it. If cells of different sizes are exposed to the same electric field, the largest cells will die first. Thus, this ability of electroporation to discriminate cells by their sizes may be used to selectively kill large cells in the human body.
- the apparatus comprises a high voltage pulse generator and an applicator having two or more electrodes utilized in close mechanical and electrical proximity with the patient's skin to apply electrical pulses thereto.
- the applicator may include at least two electrodes with one electrode having a sharp tip and another having a flat surface.
- High voltage pulses delivered to the electrodes create at the tip of the sharp electrode an electric field high enough to cause death of relatively large subcutaneous fat cells by electroporation. Moving the electrode tip along the skin creates a line of dead subcutaneous fat cells, which later are metabolized by the body. Multiple applications of the electrode along predetermined lines on the face or neck create shrinkage of the skin and the subcutaneous fat reduction under the treated area.
- the electroporation in-vivo employed in the disclosed method of treatment of subcutaneous fat, involves high voltage pulses applied to the skin of a patient. Delivery of such pulses, however, may result in the patient experiencing an unpleasant sensation of small, but palpable electric jolt or shock during pulsing.
- the electric current passing the skin and surrounding tissues between electrodes excites sensory nerves and may cause a discomfort sensation or even pain.
- This perception is the end result of a process that begins with stimulation of a peripheral sensory nerve and culminating in the conscious awareness of the pain at the cerebral cortex.
- the perception of pain begins with stimulation of a distal peripheral sensory nerve.
- the stimulation signal travels to a higher level of sensory collection, which is at the dorsal sensory nerve root ganglion just laterally of the spinal cord.
- the signal enters the spinal cord and ascends to the brain stem, from which it traverses onto the sensory strip along the cerebral cortex.
- Each area of the cortex in this strip represents a surface area of the body in a fashion known as the homunculus distribution of the cerebral cortex.
- Peripheral nerve blockade is achieved through various methods, the most common of which is a local nerve block with medications such as lidocaine injected at the procedure site.
- a variety of medications can be used in local, regional and general anesthesia. Drugs are available for local tissue injection providing a direct anesthetic block at the sensory nerve ends. Other drugs are used for intravenous delivery and disseminate throughout the entire body and produce a general anesthesia effect. Intermediate to this, medications have been developed for direct injection into nerve bundles to provide a regional type of anesthetic block. Such examples of regional anesthesia are axillary nerve blocks putting the arm to sleep, sacral nerve blocks putting the back of the leg to sleep, and saddle blocks or epidural blocks that render the entire lower half of the body anesthetized.
- Anesthetic drugs are efficient in reducing or blocking the sensation of pain, but they have their own drawbacks. They can have toxic side effects or cause allergic reactions in certain patients. Also, they can significantly increase the cost of surgical or other procedures. Whenever it is possible, it is desirable to avoid usage of the pharmacological drugs for pain control.
- the Gate Control Theory of pain was initially proposed in 1965 by Melzack and Wall and now is widely accepted by the scientific community.
- the Gate Control Theory provides that large and small diameter nerve fibers, both of which carry pain signals, travel through the same “gate mechanism.”
- the theory further provides that activated large nerve fibers can inhibit the transmission of a pain signal by the smaller nerves fibers.
- Chemicals released as a response to the pain stimuli also influence whether the gate is open or closed for the brain to receive the pain signal.
- the “Pain Gate” can be shut by stimulating nerves responsible for carrying the touch signal (mechanoreceptors). This finding enables the relief of pain through massage techniques, rubbing, and also the application of hot wheat bags or cold ice packs.
- the Gate can also be shut by stimulating the release of endogenous opioid-type chemicals that are released by the body in response to the pain stimuli.
- TENS Transcutaneous Electrical Nerve Stimulation
- TENS is used primarily for symptomatic relief and management of chronic intractable pain or as an adjunctive treatment in the management of post-surgical or post-traumatic acute pain.
- TENS usually involves the application of a sequence of short electrical pulses with relatively low repetition rate intended to affect the nervous system in such a way as to suppress the sensation of pain from acute or chronic injury.
- two electrodes are secured to the skin at appropriately selected locations. Mild electrical impulses are then passed into the skin through the electrodes to interact with the underlying nerves over the treatment site.
- TENS has proven effective in the reduction of both chronic and acute pain of patients.
- the present invention provides an apparatus and method for creation of a controlled injury or alteration to the subcutaneous tissue and/or underside of the dermis, with the following healing process leading to the contraction of the skin; and/or to the controlled destruction of fat cells, leading to their permanent loss, all with increased comfort for the patient.
- the damage to the subcutaneous tissue, underside of the dermis, and/or fat cells is caused by electroporation.
- Patient discomfort associated with using electroporation in-vivo for cosmetic purposes is attacked by an apparatus and a method according to the present invention. To do so, apparatus and method relating to TENS is incorporated into the electroporation apparatus used for reducing subcutaneous fat deposits, virtual face lift and body sculpturing to relieve a discomfort that may arise from electroporation treatment.
- the new apparatus is provided with an additional low voltage pulse generator connected to electrodes placed on a treatment site of the patient's body. Improved comfort for the patients is achieved by delivering a sequence of low voltage pulses that provide transcutaneous electrical nerve stimulation, thereby substantially blocking the neural messages of discomfort or pain that may arise from the high voltage pulsing.
- a sequence of TENS pulses may be applied before delivery begins of an electroporation pulse, with the TENS pulses continuing for some time after.
- the analgesic effect is mediated by a release of natural body analgesics triggered by TENS.
- each electroporation pulse delivered to the treatment site are synchronized with the TENS pulses.
- each electroporation pulse may be applied with a delay after a TENS pulse, namely during a refractory period for the surrounding nerves caused by the TENS pulse.
- the refractory period is a state of a nerve cell that exists for a short period of time after the onset of an excitation, approximately 0.5 milliseconds, and is characterized by an absolute inability of the nerve to be excited by a stimulus, no matter how intense this stimulus is. This is so called “absolute refractory period”.
- the high voltage pulses are applied to the patient's skin only when all or substantially all of the nerves surrounding the treatment site are in the refractory state created by a previous application of a TENS pulse.
- Application of EP pulses during the refractory period will provide significant improvement of the patient's comfort during an electroporation procedure.
- FIG. 1 is a schematic illustration of an electroporation system for cosmetic treatment with improved patient's comfort.
- FIG. 2 shows the strength-duration curve for excitation of a nerve.
- FIG. 3 is an illustration of an action potential and excitability of a nerve.
- FIGS. 4a and 4b are time diagrams of electric pulses applied to the electrodes.
- FIG. 5 shows exemplary electrodes for EP treatment combined with TENS.
- FIG. 6 illustrates another embodiment of an apparatus in accord with the present invention.
- FIG. 7 illustrates yet another embodiment of an apparatus in accord with the present invention.
- FIG. 1 shows schematically an electroporation system 10 for in-vivo treatment of subcutaneous fat deposits and tightening of the skin.
- the system includes a high voltage electroporation pulse generator 12 and electrode sets (or arrays of electrodes) 14 and 16 .
- the electrodes may be applied to a fold 18 of a patient's skin 20 with subcutaneous fat deposit 22 at a selected location on the patient's body for the purpose of applying electroporation therapy thereto.
- the high voltage electroporation pulses from generator 12 are delivered to the electrodes 14 and 16 via a multiple conductor cable 24 .
- the electrodes 14 and 16 and the cable 24 may be secured to a hand held applicator adapted for manipulation of the electrodes on the patient's skin during EP treatment (not shown in the FIG. 1 ).
- System 10 further includes a TENS generator 30 that is connected to the electrodes 14 and 16 via an appropriate connector 32 .
- a synchronizing circuit 34 may be provided to introduce a controllable time delay of high voltage EP pulses provided by the generator 12 to the electrode sets 14 and 16 relative to the sequence of TENS pulses provided by the generator 30 to the electrode sets 14 and 16 .
- Synchronizing circuit 34 may be connected to generator 12 by an appropriate connector 36 and to generator 30 by an appropriate connector 38 . This time delay may fall within a range of about 0.1 to about 1.5 milliseconds.
- a computer 40 connected by an appropriate connector 42 to synchronizing circuit 34 , by a connector 13 to EP generator 12 , and by a connector 31 to TENS generator 30 may be provided to control the whole procedure of EP treatment: the predetermined amplitude, duration, and number of EP and TENS pulses and the sequencing EP and TENS pulses supplied to the electrodes 14 and 16 .
- the TENS system generates trains of nerve stimulation pulses which are applied to the patient's skin 20 .
- TENS system generator 30 may generate pulses with a repetition rate 40-200 Hz, with each nerve stimulation pulse having a duration of approximately 20-1000 microseconds and a current peak of approximately 0.100 A.
- the EP pulses may be applied with a repetition rate of 1 to 50 Hz and may have a current peak of 0.5-10 A depending on the size and shape of electrodes or electrode arrays.
- the voltage of the EP pulses can be in the range of 50 V to 5000 V with a duration from 10 microseconds to 1.0 milliseconds depending on the location of the treated segment of the body, the sizes and shapes of the electrodes, and the distance between the electrodes. Regardless of the possible configuration of the electrodes and the voltages applied to the treatment volume, the voltage applied to an individual subcutaneous fat cell should fall in the range of 2 to 5 V per cell to be able to kill it.
- the TENS pulses are applied to the same electrodes as the EP pulses.
- TENS pulses and EP pulses are applied to different electrodes (or arrays of electrodes) placed close to each other and to the EP electrodes.
- the EP electrodes may be a set of relatively sharp needles.
- the sharp electrodes provide enhancement of the electric field necessary for efficient EP treatment of the skin cells, which are significantly smaller than the subcutaneous fat cells (5 micron diameter versus 100 micron for fat cells).
- the TENS pulses should be applied to a more extended skin area than the EP pulses. This extended coverage area is desirable so that the TENS pulses are able to excite the large nerve fibers that are responsible for the heat and touch sensations on the skin, the excitation of which actually blocks the transmittance of the pain signals.
- TENS pulses should be high enough to excite all the nerves around the electrodes that can be excited by the EP pulses.
- the delay time between a TENS and an EP pulses in this case generally may be longer than in the case of separate TENS electrodes covering a larger area. The longer delay is beneficial because the nerve excitation caused by the TENS pulse propagates around the electrode with velocity of about 4 meters per second and increases the area affected by the TENS pulse by a margin of 2 mm for the delay of 0.5 millisecond.
- this 2 mm margin is significant for reducing sensation of the EP pulse by the patient.
- the actual optimal delay may be determined during a procedure by a physician using a feedback for sensation of discomfort experienced by the patient.
- the TENS system preferably should be “on” continuously during the EP treatment or at least start for some time before the EP treatment.
- the electric field applied to the treated volume of cells must be above the upper EP limit for the cells.
- the probability of cell killing increases if longer or multiple pulses are employed. As far as the sensation of electrical pulses by the patient is concerned, it also varies with duration. The general law is: the longer pulse is, the stronger the sensual response of the patient is.
- the mathematical equation for this law usually referred to as the “strength—duration curve”, was discovered by Blair in 1932.
- the strength-duration curves illustrating the Blair equation for different excitable tissues are shown in FIG. 2 .
- the middle curve in the figure shows the strength-duration curve for the excitation of sensory nerves which are located in the skin and are responsible for the sensation of discomfort during electroporation procedure.
- the curves illustrate the relative increase in the threshold of excitation with the decrease in the duration of the electrical pulses for different excitable tissues.
- the threshold of excitation of sensory nerves (the middle curve of the three shown on the Figure) for 10-20 microsecond pulses is 20-50 times higher than that for 1 ms pulses.
- Electroporation is observed where the applied pulses have a duration of 10 microseconds and longer.
- relatively shorter multiple pulses are preferred to long EP pulses.
- the TENS pulses having lower amplitudes than the EP pulses, may be selected to be significantly longer than the EP pulses, but at lower amplitudes than the EP pulses.
- An excitation threshold of a nerve depends not only upon the duration of the stimulating pulse but also upon the immediate local excitation history of the nerve.
- FIG. 3 shows a plot of an “action potential,” which is a potential difference between the inner and the outer sides of the cell membrane as a function of time during an excitation. Normally, when a cell is at rest, the potential difference (or as commonly called, the voltage) across the membrane, called a “resting potential,” is about ⁇ 90 mV. When an electric stimulus causes local depolarization of the membrane (decreases the negative potential across the membrane) to a value about ⁇ 60 mV, called a “resting threshold”, the cell gets excited and an action potential starts propagating from the site of excitation along the nerve fiber.
- the potential across the cell membrane rapidly increases from its resting threshold of about ⁇ 60 mV to +40 mV and slowly returns back to the resting potential of ⁇ 90 mV.
- This period is called the “absolute refractory period” (the threshold is infinitely high) and generally lasts for approximately 0.75 ms after reaching the peak of the action potential at about +40 mV.
- the absolutely refractory period is followed by a “relative refractory period”, where a stimulus greater than normal is needed to initiate an action potential.
- the evolution of the level of the excitation threshold during an action potential is shown in FIG. 3 by a dashed line.
- the threshold of excitation of a cell at rest depends not only on the duration of the electrical stimulus but also on the waveform of the stimulus.
- the threshold for a bipolar pulse consisting of two parts, a positive one and identical in shape but negative in polarity, is higher than that for a unipolar pulse.
- the reason for that is that the cell launches an acting potential only when the resting threshold of the excitation is reached. This happens when a change of the electrical charges on both sides of the membrane occurs that depolarizes it from ⁇ 90 mV to ⁇ 60 mV. If a bipolar pulse is applied to the cell, only the first half of the pulse causes a depolarization of the cellular membrane that can lead to a firing of an action potential.
- the reversing electric current polarizes the membrane back to the previous level of ⁇ 90 mV.
- all nerves including sensory are less sensitive to bipolar pulses than to unipolar of the same overall duration. Actually, their sensitivity approximately corresponds to that of a unipolar pulse with a half duration.
- Bipolar rectangular pulses are known to be very efficient in cell killing by electroporation. Contrary to the sensitivity of excitable cells to electric stimulus, both directions of the electrical field, that is, positive (+) and negative ( ⁇ ), are equally efficient in creating pores in cellular membranes. This efficiency results because electroporation is a process is related to the difference in the energy of the porous and non-porous membrane in the presence of an electric field. This energy difference depends on the square of the amplitude (or strength) of the electric field (i.e., E 2 ) and does not depend on the sign or polarity (+ or ⁇ ) of the electric field.
- bipolar pulsing is free from these drawbacks. With the bipolar pulsing problems such as metal depositions from the electrodes or chemical decomposition of tissue during treatment are largely if not completely avoided.
- balanced pulses namely, lower excitability of the nerve cells, high efficiency in cell killing and freedom from electrolytic effects, make using rectangular bipolar balanced pulses a preferred mode for electroporation pulsing in the current invention.
- balancing of two pulses of the opposite polarities may be easily achieved by using a pulse generator having a direct current blocking capacitor electrically coupled in series to the transcutaneous electrodes.
- FIGS. 4a and 4b The time diagram of the pulses applied to the electrodes are shown in FIGS. 4a and 4b .
- voltage is plotted as a function of time for the
- FIGS. 4a and 4b voltage is plotted as a function of time for the EP pulses designated for cell killing (the upper curve in each of FIGS. 4a and 4b ), and the TENS pulses applied for mitigation of discomfort of the patient (the lower curve in each of FIGS. 4a and 4b ).
- FIG. 4a bipolar balanced rectangular EP pulses and exponential balanced TENS pulses are shown. This is the preferred embodiment for the EP—TENS treatment of the current invention.
- FIG. 4b shows unipolar exponential pulses.
- the time delay ⁇ t between preselected TENS and synchronized EP is introduced into pulsing to ensure that the high voltage pulses are applied during the refractory state of the surrounding nerves to minimize discomfort of the patient.
- This time delay falls into a range of 0 to about 1.5 milliseconds and can be selected during the treatment procedure for the best comfort of the patient
- the EP pulses depend upon the size of the electrodes and the distance between them and may be in the range of about 50 V to about 5000 V with a duration of about 10 microseconds to about 1.0 milliseconds.
- the TENS pulses may have duration of about 20 to about 1000 microseconds.
- FIGS. 5-7 show different embodiments of applicators for combining EP and TENS treatment.
- two large pad electrodes, positive 50 and negative 52 provide TENS treatment for the area 54 of the skin 56 between the pads 50 and 52 .
- One electrode of the EP generator, exemplary positive is connected to pad 50
- the second, negative polarity electrode of the generator is connected to a needle electrode 58 , thereby providing EP treatment in the area between the pad electrodes 50 and 52 .
- the pads would be applied to the skin and held there in a known manner, while the needle electode 58 would me manually or mechanically manipulated as desired in the area between the pads.
- a multi-needle applicator 60 having a hand piece 62 .
- Handpiece 62 is attached to a frame 64 of a desired configuration carrying a an array of needle electrodes 66 comprising a plurality of needle electrodes 68 and 70 .
- Some of the needle electrodes may be connected to a TENS generator to function as TENS electrodes alone, while needle electrodes 70 may be connected to both the TENS and EP generators to function as both EP and TENS electrodes. It will be observed that placing the combined EP and TENS electrodes 70 inside the periphery of the TENS only electrodes 68 that a TENS coverage area exceeding the EP coverage area is achieved.
- the appropriate connectors 72 and 74 are used to connect the applicator 60 , and thus the needle electrodes 68 and 70 , to the EP and TENS generators.
- FIG. 7 shows a two electrode applicator 80 including a handle 82 .
- both electrodes 84 and 86 are common for EP and TENS processes.
- the TENS pulses should be selected to be generally longer in duration and higher in the amplitude while the EP pulses should be short and multiple with a relatively long delay time. This choice of operating parameters of the system will ensure that the TENS treatment is provided to the whole area where the EP pulses can possibly excite the sensory nerves.
- apparatus in accord with the present invention will include using TENS electrodes to create an anesthetic effect in at least the treatment volume and preferentially in a larger volume of patient tissue that includes the treatment volume.
- This anesthetic effect can be created by application of TENS pulses to the patient.
- EP pulses can be applied to the treatment, resulting in the death of some or all of the subcutaneous fat cells in the treatment volume.
- Other patient tissue treatment volumes can then be treated similarly.
- the present invention provides apparatus and method for reducing subcutaneous fat deposits by electroporation with improved comfort of patients.
Abstract
Description
I=b/(1−e−d/τ);
where:
-
- d=the pulse duration;
- b=the threshold excitation current density for an infinitely long pulse;
- I=the threshold excitation current density for a pulse with duration d; and
- τ=the membrane time constant for a particular excitable tissue.
Claims (22)
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US12/571,974 USRE42835E1 (en) | 2000-08-17 | 2009-10-01 | Apparatus and method for reducing subcutaneous fat deposits by electroporation with improved comfort of patients |
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US22577500P | 2000-08-17 | 2000-08-17 | |
US26710601P | 2001-02-08 | 2001-02-08 | |
US09/931,672 US6892099B2 (en) | 2001-02-08 | 2001-08-17 | Apparatus and method for reducing subcutaneous fat deposits, virtual face lift and body sculpturing by electroporation |
US35597002P | 2002-02-12 | 2002-02-12 | |
US10/364,187 US6697670B2 (en) | 2001-08-17 | 2003-02-11 | Apparatus and method for reducing subcutaneous fat deposits by electroporation with improved comfort of patients |
US12/571,974 USRE42835E1 (en) | 2000-08-17 | 2009-10-01 | Apparatus and method for reducing subcutaneous fat deposits by electroporation with improved comfort of patients |
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US20110238051A1 (en) * | 2010-01-25 | 2011-09-29 | Zeltiq Aesthetics, Inc. | Home-use applicators for non-invasively removing heat from subcutaneous lipid-rich cells via phase change coolants, and associated devices, systems and methods |
US8676338B2 (en) | 2010-07-20 | 2014-03-18 | Zeltiq Aesthetics, Inc. | Combined modality treatment systems, methods and apparatus for body contouring applications |
US8702774B2 (en) | 2009-04-30 | 2014-04-22 | Zeltiq Aesthetics, Inc. | Device, system and method of removing heat from subcutaneous lipid-rich cells |
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