KR20180006365A - Systems and devices for identifying and limiting nerve conduction - Google Patents

Abstract

Methods and devices for improving precision in disrupting the discovery of one or more nerves and subsequently the transmission of neural signals through the target nerve are disclosed. The treated nerve can not transmit neural signals for a selected period of time, which can be a temporary basis (e.g., hours, days, or weeks) or a long period / permanent basis (e.g., months or years) . One embodiment of the device includes an accurate energy source system featuring an energy transfer element capable of forming ablation zones with nerve destruction, inhibition and precision.

Description

Systems and devices for identifying and limiting nerve conduction

This application is related to U.S. Patent Application No. 14 / 602,180, filed January 21, 2015; U.S. Patent Application No. 14 / 602,187 (now U.S. Patent No. 9,113,912, issued August 25, 2015); And U.S. Patent Application No. 14 / 602,196 (now U.S. Patent No. 9,119,628, issued September 1, 2015), each of which is incorporated herein by reference.

SUMMARY OF THE INVENTION The present invention is directed to methods and devices that improve the precision of detecting one or more nerves and inhibiting the transmission of nerve signals through the target nerve. The treated neurons become unable to transmit neural signals during a selected period of time, which may be on a temporary basis (e.g., hours, days, or weeks) or longer periods / permanent periods (e.g., As shown in FIG. One embodiment of the device includes a precise energy source system characterized by energy transfer elements capable of generating ablation with nerve breakdown regions, inhibition and precision.

The human nervous system transmits and receives signals to convey both sensory information such as pain, heat, cold and tactile sensation, and command signals to control muscle movement. There are many cases in which impairing neural signals can provide preventative, therapeutic, and / or cosmetic benefits to individuals. For example, extraneous, undesired, or abnormal signals may be generated (or communicated) along neural system paths. For example, twisting small nerves in the posterior can cause extreme back pain. Similarly, compression or other activation of certain nerves may cause significant or constant pain. Certain diseases can also seek linearization of the nerves, so the neural signals are spontaneous. These spontaneous outbreaks can lead to a variety of chronic diseases ranging from seizures to pain (from extreme conditions) to death. Abnormal signal activation can cause many other problems, including (but not limited to) twitching, tics, seizures, distortions, cramps, disabilities (In addition to pain), other undesirable conditions, or other painful, abnormal, undesirable, socially or substantially deleterious afflictions.

In some situations, the normal conduction of neural signals causes facial wrinkles, which may result in permanent twisting of the eyebrows (forehead), which undesirable muscles give rise to a mature aging appearance. Supercilli of the corrugator Blocking the neural signals of the activated nerves can alleviate eyebrows or forehead twist.

Conventional electrosurgical processes use a single polar or bipolar device connected to an energy source. The unipolar electrode system includes an electrode with a small surface area and a return electrode disposed in contact with the body at a spaced apart location from the electrode with a small surface area. The return electrode is generally large in size and is resistively or capacitively coupled to the body. The same amount of current must flow through each electrode to complete the circuit. Since the return electrode typically has a large surface area, so heat can be consumed over a larger surface area by the reduced current density. In some cases, it is desirable to place the return electrodes in a high blood flow area (biceps, buttocks or other muscles or very vascularized areas) so that the generated heat can be consumed quickly. One advantage of the unipolar system is the ability to accurately position the unipolar probe at the required site and properly center the electrosurgical energy at a given location. The resistive return electrode may typically be coated with a conductive paste or jelly. If contact with the patient is reduced or the jelly dries, a high current density region can occur, increasing the likelihood of combustion at the point of contact.

Conventional bipolar electrode systems are generally based on devices having electrodes of opposite polarity. Each electrode is connected to one of the two electrodes of the electrosurgical generator. When electrosurgical energy is applied, energy is concentrated so that current flows between the electrodes of opposite polarity in the device region. If the tool is assumed to be properly designed and used, the current generated will be limited in the target tissue between the two surfaces. Removal of glabellar furrowing was performed by the Plastic Reconstructive Surgery 95 691-696 of Corrugator Supercilli® Muscle Resection Through Blepharoplasty Incorporation 1995), the forehead lift surgery described by Guyuron, Michelow and Thomas, and myotonic muscle deflection muscle surgery. In addition, the surgical segmentation of the apical motor deflection motor nerve has been described by Corrugator Supercilli Muscle (Clinical Significance and Development of a New Surgical Technique for Frowning, J Otolaryngology 27; 222-227 (1998) by Ellis and Bakala of the anatomy of motor neuron distribution. These techniques are very aggressive and sometimes transient because the nerves regenerate over time and require repeated or alternative surgery.

Another less aggressive procedure for the treatment of intracranial indwelling involves injecting a Botulism toxin (Botox) directly into the muscle. This was the best described in the New England Journal of Medicine, 324: 1186-1194 (1991), which results in flaccid paralysis. Once minimally invaded, this technique is predictably temporary; So, it has to be replayed every few months.

A special effort to use RF energy through the two needle bipolar systems has been shown to be an effective alternative to the use of percutaneous selective radio-frequency neuroablation in plastic surgery in plastic surgery, anesthetic plastic surgery, 18:41 pp 41-48 (1994) by Hernandez-Zendejas and Guerrero-Santos. The authors have described a bipolar system that uses two parallel needle-like electrodes. Utley and Goode, US Pat. Nos. 6,139, 545 and Archives of Facial Plastic Surgery, January-March, 99, VI P 46-48, Similar systems have been described in the radioactive ablation of the nerves. These systems obviously can not produce permanent results due to inherent limitations of the bipolar structures of the two needles. As such, in the case of Botox, parallel needle electrode systems will typically require periodic iterative processes.

There are many ways to determine the proximity of the nerve to the nerve so that the active electrode is properly positioned near the target tissue and treatment is restricted to the area of interest. In many instances, there is a need to ensure that the nerves are located and treated so as to produce a certain effect while minimizing collateral damage to surrounding tissues. This is especially true for cosmetic applications.

A variety of stimulation devices have been developed and patented. One stimulation and ablation procedure using two needle-systems is disclosed in U. S. Patent No. 6,139, 545. Stimulation can also be performed negatively, and tissues that do not respond to stimulation are ablated as disclosed in U.S. Patent No. 5,782,826 (issued July 21, 1998).

SUMMARY OF THE INVENTION The present invention is directed to devices and methods for deploying a treatment device adjacent to a nerve, stimulating the nerve and then performing a remedial action to repair the ability of the nerve to deliver the nerve signal. In particular, the devices and methods of the present invention can be used for cosmetic purposes in the head and face regions. However, these devices and methods can be used in any other part of the body.

The present invention includes a method of treating neurons in a tissue area. One example of such a method includes positioning an operative end of a device including a stimulation mode and a treatment mode within a tissue area, the stimulation mode comprising at least a first parameter setting to stimulate the nerve at a first distance from the working end, Wherein the first distance is greater than the second distance and the device is configured to prevent activation of the treatment mode when the stimulation mode is in the first parameter setting ; Activating the device in the stimulation mode at the first parameter setting to observe the nerve stimulation; Relocate the operative end of the device into the tissue region to move the operative end closer to the nerve; Reactivating the device in the stimulation mode in the second parameter setting to observe the nerve stimulation and confirming relocation of the working end of the device to be closer to the nerve; And activating the device in the treatment mode to create a first treatment area in the nerve at the predetermined treatment setting, and activating the device in the treatment mode, the device resets the first parameter setting.

The method further comprises moving the operative end in a predetermined direction relative to the nerve to produce a plurality of treatment zones along the nerve. In certain variations, moving the working end of the device in a constant direction relative to the nerve involves moving the working end of the device in a forward direction away from the first treatment area along the nerve, so that the muscle associated with the nerve is stimulated during nerve stimulation .

Modifications of the methods of the present invention include positioning the working end of the device and rearrangement of the working end of the device occurs without detaching the device from the puncture site. Moving the device includes moving the device in a plurality of directions without removing the device from the tissue region to increase the area for observing the nerve stimulus.

The method also includes injecting an anesthetic in or near the first treatment zone prior to operating the device in the treatment mode.

The methods and devices may also include applying energy and lowering the skin surface temperature above the treatment site prior to maintaining the ice during energy application.

In a further variation, the methods can further include using an external nerve stimulator to insert the device and align the nerve tissue to the skin prior to using the map as a guide to identify target treatment locations.

In certain variations, the first parameter setting includes a first current setting and the second parameter setting comprises a second current setting, wherein the second current setting is less than the first current setting. The first parameter setting can be fixed and / or the second parameter setting can be adjusted.

The method may also include activating the device in the stimulation mode at the first parameter setting to observe the nerve stimulation, including observing movement of the tissue area surface. The method may also include activating the device in the stimulation mode at the first parameter setting to observe the nerve stimulation, including performing an electromyography test on at least one muscle associated with the nerve. In addition, activating the device in the stimulation mode in the first parameter setting to observe the nerve stimulation comprises measuring the electrical impulse of the at least one muscle associated with the nerve using the measurement electrode.

In another example, the invention includes a neurotherapeutic method in a tissue area. In one variant, the method includes positioning the device in a tissue region at a first location; Applying energy to the tissue region through the device at a first location using a first configuration configured to stimulate the nerve within a first distance from the operative end of the device; Observe nerve stimulation; Re-applying energy into the tissue region through the device at a second location using a second configuration configured to stimulate the nerve within a second distance from the working end of the device, the first distance being less than the first distance; Re-measuring whether the nerve is stimulated in a second setting to determine whether the second position is closer to the nerve than the first position; And applying energy to affect the performance of the nerve to transmit the nerve signal using the device when observing the nerve stimulation that the second position is closer to the nerve using the second setting.

The method may include resetting the device to a first setting after application of energy to the nerve, the method comprising resetting the device to a second setting, the method further comprising re-adjusting the device to a second setting And then reapplying energy to the tissue region through the device at a subsequent location using a second configuration configured to stimulate the nerve within a second distance from the working end of the device.

The method may also include moving the device in a predetermined direction relative to the nerve to create a plurality of treatment areas along the nerve. Moving the device in a certain direction relative to the nerve involves moving the device along the nerve in a forward direction away from the first position so that the muscle associated with the nerve can be stimulated during nerve stimulation. In a further variation, placing the device in the first position and the second position occurs without removing the device from the puncture site.

The method further includes moving the device in a plurality of directions without removing the device from the tissue region prior to reapplying energy at the second location. The method may also include injecting an anesthetic at or near the tissue region at a first location site prior to applying energy to the tissue site.

In yet another variation, a method includes positioning an operative end of a device configured to apply stimulation energy and therapeutic energy into a tissue region at a first location; When supplying stimulus energy, the device can be set to one of a plurality of settings including at least a first setting and a second setting, wherein the stimulating area of the device is larger when the device is operated in the first setting, 1 < / RTI >setting; Operate the device with a second setting; Observe the responses of tissue regions to nerve stimulation; Upon observing the response, therapeutic energy is applied to at least a portion of the nerve to prevent the nerve from transmitting a nerve signal by applying therapeutic energy into the tissue region, and after application of the therapeutic energy, the device is reset to the first setting; Rearranging the working end of the device in a subsequent position; Adjusting the device from the first setting to the second setting; Observe subsequent responses in the tissue region for nerve stimulation; And applying therapeutic energy to at least a second portion of the nerve at a subsequent location by applying therapeutic energy when observing a subsequent response.

The method may include moving the device in a predetermined direction relative to the nerve to create multiple treatment intervals along the nerve.

In yet another variation, a method of treating a nerve includes inserting a single longitudinal probe into a tissue region that includes a critical stimulation current setting, wherein the probe is prevented from applying therapeutic energy at or above a threshold stimulation current setting; Directing the probe tip toward the nerve; Initiate the movement of the nerve-associated muscles by supplying a stimulating current through the probe; Decreasing the stimulation current setting below the threshold stimulation current setting such that the stimulation area of the probe is reduced; Move the probe within the tissue region towards the nerve; Stimulating the nerve to move the muscle so that the nerve position is within the reduced stimulation area of the probe; When observing the movement of the muscle, a current is applied to heat the nerve, and after application of the current, the stimulation current setting is reset to the critical stimulation current setting.

The present invention also encompasses a system for treating neurons in a tissue area comprising: a probe having an operative end for placement in a tissue region; A controller configured to supply power to operate the probe in a treatment mode and a stimulation mode; The controller is also configured to be adjustable between a plurality of stimulation settings that include at least a first stimulus setting and a second stimulation setting and to prevent powering in a treatment mode when the second stimulation setting is not set , The effective stimulation area of the probe in the second stimulation setting is reduced relative to the effective stimulation area of the probe in the first stimulation setting so that the working end of the probe is in the second stimulation setting rather than the first stimulation setting Closer to the nerve; And the controller is configured to be reset to a first stimulus setting after power is applied in the treatment mode.

The system may include an anesthetic supply that is fluidly connected to an aperture in the operative end of the probe. In some variations, the first stimulus setting is fixed. Alternatively, or in combination, the second stimulation setting can be adjusted.

The system may include an energy transfer section above the working end, the energy transfer section comprising a first conducting portion and a second conducting portion, at least longitudinally spaced apart from the probe. The first conducting portion and the second conducting portion are separated by an electrical insulating material.

Variations of this system may include a fluid port located between the first conducting portion and the second conducting portion on the working end.

In some variations, a temperature sensing element is positioned between the first conducting portion and the second conducting portion.

The system may also include an illumination source at the working end. The illumination source may include a modulated flash rate that is proportional to the amount of stimulus energy.

The device may also include a lumen arranged to operate along the length of the single axis probe.

The present invention may also include an electrosurgical device for use with a reservoir having flowable material and for use with a stimulating energy source and a therapeutic energy source to stimulate and treat subcutaneous tissue. For example, the device comprises: a device body; A rigid probe extending from a portion of the device body and configured to allow movement of the probe within the tissue by manipulation of the device body; A distal electrode positioned at an operative end of the probe; And applying a therapeutic energy to the distal electrode and the proximal electrode to cause damage to the tissue region across the proximal and distal electrodes, wherein the distal and proximal electrodes are proximate to the distal electrode A proximal electrode positioned on a dail probe spaced apart; And a fluid supply sleeve positioned between the distal electrode and the proximal electrode and having at least one fluid port for directing the at least one fluid port to supply the fluid material in a direction perpendicular to the probe axis such that the fluid material is directed to the tissue region do.

The device may also include a fluid supply lumen for supplying axially flowable material supplied into the tissue from the tip of the probe.

The invention also includes systems for performing or implementing the treatment described herein. Such a system includes a device and a controller and includes a system for treating a nerve in a tissue area, wherein the controller is coupled to a device having an operating end and includes a stimulation mode and an energy delivery mode, At least a first parameter setting for stimulating the nerve at a first distance from the end, and a second parameter setting for stimulating the nerve at a second distance from the working end, wherein the first distance is greater than the second distance, Is configured to prevent activation of the energy supply mode when the first parameter setting is in the first parameter setting; When the working end of the device is in the tissue region and activated in the stimulation mode, the controller provides energy in the first parameter setting so as to stimulate the nerve; And when the operating end of the device is repositioned in the tissue region to move the working end closer to the nerve and reactivated to the stimulation mode in the second parameter setting, the controller can energize to stimulate the nerve, Confirming that the end is repositioned closer to the nerve; And when the device is activated in the energy supply mode, the controller supplies energy to generate the first treatment interval in the nerve at the predetermined treatment setting, and activates the device in the energy supply mode, and the controller resets the first parameter setting .

Another variation of the system includes a system for treating the nerves and associated muscles of the nerves, the system comprising: a single longitudinal probe configured to be inserted into the tissue region and coupled to the controller; A threshold stimulation current setting on the controller wherein the probe is prevented from applying therapeutic energy in or above the threshold stimulation current setting; The controller further includes a stimulation current setting that allows the energy to be delivered through the probe to actuate motion of the muscles associated with the nerve; The controller is further configured to reduce the stimulation current setting below a threshold stimulation current setting such that the stimulation area of the probe is reduced; Confirming that the stimulation of the nerve by the probe when the stimulation current setting is since the threshold stimulation current setting has a nerve position within the reduced stimulation area of the probe; The therapy setting is configured such that the therapy setting on the controller is applied when the stimulation current setting is below the threshold current setting on the controller and the probe can apply an electric current to heat the nerve by applying the current in the treatment setting, Is configured to reset the stimulation current setting over the critical stimulation current.

The systems described herein may include at least one infusion port at the operative end of the device and a fluid supply for anesthetic or medicament.

The system may include an external nerve stimulator configured to match the nerve tissue to the skin prior to inserting the device for use as a guide to identify the target treatment location.

The system may be configured such that the first parameter setting comprises a first current setting and the second parameter setting comprises a second current setting, wherein the second current setting is less than the first current setting. The first and second parameter settings may be fixed or variable.

The system may also include a measuring electrode, and operating the device in the stimulation mode at the first parameter setting to observe the nerve impulse comprises measuring the electrical impulse of the at least one muscle associated with the nerve using the measuring electrode do. The system may be configured so that the prescribed treatment setting includes a predetermined temperature.

Certain systems can be configured such that the device or controller includes a manual override so that the energy supply mode can be applied when the stimulation mode is in the first parameter setting.

These and other features of the present invention, including combinations of parts and details of various configurations, and other advantages will be more fully described with reference to the accompanying drawings, and will be described in the claims.

It is to be understood that the specific methods and devices for implementing the invention are shown by way of example only and not as limitations of the invention. The principles and features of the present invention may be applied to various embodiments without departing from the scope of the present invention.

Not listed

These and other objects, features, and advantages of the methods, devices, and systems described herein will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, in which like reference numerals designate like parts and in which: FIG. The drawings are not necessarily to scale, emphasis is given to illustrate the principles of the invention.
Figure 1 illustrates an example of a device configured for treatment and stimulation of neurons.
Figure 2 illustrates another variation of a treatment device coupled to a reservoir supply member and a controller / power supply.
3A illustrates a variation of the working end of a single axis probe having at least one energy transfer region with sensors and / or a fluid supply port located at the working end.
Figure 3B illustrates another variation of the operating ends of the device described herein.
3C shows an example of a device that is located in the tissue of the energy transfer region in the tissue and produces a lesion created in the tissue.
Figures 4A-4G illustrate the use of the systems and devices described herein when used to perform patient care.
Figure 5 illustrates another feature of a dual function device in which fluid ports are located in a device that supplies material between the therapeutic portions of the device.
Figures 6A and 6B illustrate various additional examples of creating a treatment site that generates treatment benefits.
FIG. 6C illustrates an example of another lesion generated on a rigid nerve in the manner described herein.
Figure 7 illustrates a bi-polar driver system.
Figure 8A is a schematic illustration of a bipolar needle.
8B is a schematic illustration of a divided bipolar needle.
9A is an enlarged side view of a conical bipolar probe.
9B is an enlarged side view of the bipolar probe of the hollow chisel.
9C is an enlarged side view of a tapered conical bipolar probe.
9D is an enlarged side view of the divided conical bipolar probe.
10 is a schematic diagram of a bipolar driver system.
11A is an assisted probe-free resection procedure.
11B is a resection operation with an auxiliary probe.
12A is a side view of a hybrid bipolar needle for nerve ablation.
12B is a side view of a hybrid bipolar needle for tumor resection.
13A is a side view of an auxiliary nerve probe;
Figure 13B is a side view of the secondary dual-ended nerve probe.
Figure 14 is a side view of a guided ablation surgery with an auxiliary neuro probe (s).
15 shows an example of electrosurgical waveforms.
16A-B are a controller and probe database structure.
Fig. 17 is a side view of a visually guided ablation surgery.
18 is a side view of a single axis electrosurgical probe having electrodes of uniform surface area.
19 is a side view of a single axis electrosurgical probe having two electrodes of different surface area.
20 is a side view of a single axis electrosurgical probe having two electrodes of different surface area.
21 is a side view of a single axis electrosurgical probe having three electrodes.
22 is a side view of a single axis electrosurgical probe having three electrodes and a curved handle portion.
23 is a side view of a single axis electrosurgical probe having a plurality of electrodes across the nerve.
24 is a side view of a single axis electrosurgical probe having a plurality of electrodes parallel to the nerve.
25 is a side view of a single axis electrosurgical probe having a plurality of electrodes across the nerve with a constant electrode.
Figure 26 is a representation according to the table of therapeutic energy protocols consistent with the present invention.
Figure 27 is a graphical representation of a therapeutic energy protocol consistent with the present invention.

The following examples are examples of methods and devices included in the present invention described herein. It is contemplated that combinations of particular embodiments themselves or combinations of aspects of particular embodiments are within the scope of the present invention. The devices, methods, and systems described herein are described as being used for neurotherapeutic, particularly neurological treatment for cosmetic purposes, and the devices, methods, and systems of the present invention may be used to treat other Lt; / RTI >

This application claims the benefit of US Provisional Application No. 10 / 870,202, Pub. No. US-2005-0283148-A1, filed June 7, 2004, which is incorporated herein by reference in its entirety. Application Serial No. 14 / 594,935, Publication No. US-2007-0060921-A1, filed January 12, 2015; 14 / 594,935, filed January 12, 2015; 12 / 612,360, Pub. No. US-2010-0114095-A1, filed November 4, 2009; 13 / 570,138 filed on August 8, 2012, publication number US-2013-0046292-A1, present patent No. 8666498; No. 14 / 156,033 filed January 15, 2014, publication number US-2010-0114191-A1, present patent No. 8938302; And Application No. 14/599, filed on January 16, 2015, which are incorporated herein by reference.

Figure 1 illustrates an example of a device 100 configured to treat and position the nerve. As will be described below, the device 100 is part of a system that is capable of identifying neurons and also providing energy to interfere with the ability of the neurons to transmit signals. In many cases, energy has a thermal effect on the nerves. However, therapeutic modalities can be used to interfere with the ability of the nerve to transmit neural signals. As illustrated, the modification of device 100 may be ergonomically designed so that a physician can grasp device 100 and position device 100 and / or working end 104 using precise autonomic nervous technology And a device body 102 that can be used. Typically such an arrangement may achieve a balance of the device body 102 in the web or hand 2 of the hand 2 between the fingers 4 and the thumb 6. However, the devices and methods described herein may include a large number of structures that allow for placement. Further, by the modification of the devices, it can be arranged using an automated mechanism such as a robot manipulator and / or positioners. The deformation of the device 100 may include features that can be manipulated by left and right hands. Alternatively, the device body 102 may be symmetrical such that it can be manipulated with left and right hands.

Figure 1 also illustrates a switch 112 that is mounted on the device body 102 to allow the physician to supply energy easily and safely in a stimulation mode or in a therapeutic mode. Again, a modification of the device may include a switch external to the device body 102, e.g., a foot pedal, an audible command, or other starting means. However, the illustrated variation shows the rocker switch 112 in which the front 114 and rear 116 locking or triggering motions of the switch 112 can increase or decrease the intensity of the stimulation signal. Thus, the system shown in FIG. 1 and the systems described herein include a dual purpose system that can operate in a nerve stimulation mode and ablation / treatment mode.

As described below, the physician can adjust the degree of attractiveness and stimulation (i. E., Range from the device from which the nerve is stimulated) without moving the hand 2 from the device 100 or the device. The device body 102 may generally comprise three operating switches (or a single switch with three positions). In the illustrated figures, the lateral actuation / positions 114 and 116 of the switch 112 can increase or decrease the stimulation current (range) of the device. The center operation / position 118 starts the stimulation mode. Once the physician specifies an acceptable treatment site, the physician may initiate a therapeutic energy supply mode by pressing a switch (e.g., 152 or 154) of the switch. In many cases, the physician may press the foot pedal 152 to initiate a treatment mode. Such features minimize the operation of unintentional therapy modes. However, variations of the device include the use of selection switch 154 located in device 100. In further variations, the treatment mode may be operated from the controller 150 and / or the continuously operated switch 112.

Additional variations of the device may include activation of the energy supply mode by either end of the switch and activation of the stimulation mode through the center of the separate pedal or switch as shown. Alternatively, or in combination, a separate switch (e.g., 154) may be located anywhere in the device body 102. Figure 1 illustrates a sealed rocker switch 112 located in the front third of the device body 102. Such a structure makes it possible to perform an easy operation by the doctor's forefinger or the thumb. Again, although the figure illustrates a rocker switch, other single switches, multiple switches, and / or switch types with multiple functions are suitable for this aspect of the invention.

Figure 1 also shows the working end 104 of a device 100 that includes a single axis probe. Although the following illustrated examples include electrosurgical energy aspects, other energy aspects may be used instead of, or in combination with, electrosurgical aspects. For example, such aspects include: cooling, cryogenic, thermal RF, thermal (resistive heating), microwave, focused or unconcentrated ultrasound, heat, specific heat DC, UV, radiation, May be employed to reduce or otherwise control the performance of the nerve.

Figure 1 schematically illustrates a device 100 coupled to a power supply 150 that can provide the energy required to perform the treatment and the stimulation energy used to position the nerve. Additional variations consider a separate power supply (not shown) to drive / control the stimulation energy. In further variations, the handle 100 may include a power supply. The term power supply is intended to include a unit in which the controller regulates the energy supply from the power supply. Thus, the power supply 150 described herein may include a condenser. Alternatively, the controller includes a separate physical unit.

The device described herein may also employ various features to provide feedback to a medical practitioner. For example, Figure 1 illustrates a feedback indicator that can provide feedback to a medical practitioner. Feedback can be visual, tactile, vibration, voice, or a combination thereof. The illustrated variation illustrates a feedback indicator 120 that is directed toward the distal end of the device body 102. Variations of the device allow the indicators to be located at certain portions of the device 100 and / or at multiple locations of the device. The feedback may include an indication of the generator condition, treatment number, whether the device is within an acceptable range of target nerve or ablation site.

FIG. 1 also illustrates an exemplary working end 104 of the device 100. FIG. As described herein, the working end typically includes a single-axis probe 105 having a distal end 106. [ In certain variations, the distal end 106 includes a tip for inserting the working end 104 into tissue. Alternatively, the distal end 106 may include a blunt shape that allows penetration of the working end 104 into tissue, but minimizes undesirable ancillary damage to the tissue. The working end 104 will also include one or more energy supply regions 106, 108, 110. For example, if the energy aspect comprises an electrosurgical device, the working end 104 may include one or more electrodes 106, 108, 110 that are electrically isolated to pass current in a bipolar or unipolar fashion.

One of the probes disclosed herein may include an illumination source 107, such as a laser source, fiber optic illumination, or light emitting diode, to assist in penetrating tissue and locating on the skin tissue. The illumination source may be driven through the controller / power supply 150 or may be driven by a source within the device body 102 itself.

FIG. 2 illustrates another variation of the treatment device 100 connected to the reservoir supply member 170. The device may also include a cable 122 or other connector connecting the device 100 to the controller / power supply 150. In the illustrated variation, the connector includes a hub 124. However, according to an alternative variant, a device 100 that is directly wired to the controller 150 is possible.

The Fig. 2 variant also shows the reservoir 170 as a separate syringe. Alternative variations of the device, however, include a reservoir fluidly connected to the working end 104 through the cable 122 or hub 124 of the device 100. In such cases, there will be a means to pressurize or start the flow of material in the reservoir. Reservoir 170 typically includes a fluid source or variants of injectable particulate, gel, or other non-fluid intrinsic material. The reservoir 170 may provide a predetermined type of fluid to the working end 104 of the device 100. In the illustrated example, the reservoir 170 includes a syringe with a plunger. Alternative variations include a reservoir connected to electrical or automated dispensers.

Typically, the material of reservoir 170 comprises an anesthetic solution, a cooling liquid, a conductive fluid, a drug, an aesthetic agent, and / or other suitable bio-active agent. Variations of devices and methods include the supply of multiple materials through a device or to a target location. For example, a saline solution can be supplied to the target location to adjust the tissue impedance and anesthetic can be supplied before, during, or after the supply of the water fluid. As will be described below, the reservoir 170 is in fluid communication with the ports so that fluid can be supplied to or near the treatment site at the operative end. The material can be supplied at all times, including during intrusion of the tissue, during transport within the tissue, and / or before / during / after stimulation and / or energy delivery. The substance may be a controlled quantity to be supplied each time or an adjustable quantity to be supplied on the basis of a physician's preference. Moreover, the supply can occur automatically before, during, or after the treatment.

FIG. 2 also illustrates a controller / power supply 150 with a visual display 150. The visual display can provide treatment information and device information for the physician. For example, the system may provide information on the number of treatments applied; The system may provide information about whether the treatment was successful (e.g., the time at which the target site maintains and maintains the predetermined temperature). The time may also provide information about the temperature and time profile of each treatment. For example, in one variant, the controller includes a number of predetermined selectable treatment settings (e.g., 80, 70, and 85 degrees F) and attempts to maintain the treatment site for a predetermined time (e.g., 30 seconds) at these temperatures. In some variations, the surgeon can determine the setting to use based on the location of the target site, or determines whether the skin is very shallow or thin at the target site. The controller can also set an interruption temperature above which treatment is interrupted. In one example, the shut down temperature may be as high as 93 ° F or 130 ° F. The controller can also monitor the temperature during treatment, and if no temperature rise is detected, the controller can interrupt treatment or apply a low power amount. Additional safety measures may be employed, such as a step-up approach to the target temperature through a number of intermediate temperatures (e.g., x body temperature over time to reach the target temperature). In addition, the system can monitor the impedance and set the imme- diate impedance at which treatment is stopped. As an example, the system can monitor for impedances between 100 and 500 ohms with a limit of about 2000 ohms.

The illustrated variant of Fig. 2 also illustrates an ergonomic device (not shown) suitable for operation by one hand of the device 100 with the device body 102 balanced on the web of the user's hand between the thumb and forefinger, And includes a main body 102. With this arrangement, the user can place one hand on the switch 112 to actuate the switch 112 in the front 116 and rear 114 directions to adjust the stimulation setting of the system. As described above, in certain modifications, the stimulus intensity of the device 100 can be adjusted by the forward (116) and backward (114) motions, and when the target position is properly identified, The user can select the trigger 118 to apply the stimulation energy. Once the physician identifies the target site, the physician may manipulate a predetermined number of switches 152,154 in the combination described above to begin treatment of the tissue area.

3A illustrates one variation of the working end 104 of a single axis probe 105 having at least one energy transfer area and / or fluid supply ports located at the working end 104 by the sensors. A variation of FIG. 3A includes a first or terminal energy transfer region 122 and a proximity transfer region 124. For example, the two energy transfer regions 122, 124 may include electrodes of opposite polarity when using an RF energy supply. As shown, the two electrodes 122, 124 are located on either side of the supply ports 132 extending through the sleeve 130 or a fluid supply lumen in fluid communication with the reservoir (such as shown in FIG. 2) Lt; RTI ID = 0.0 > a < / RTI > Optionally, a sensor 126 (such as a temperature sensing element) may be positioned adjacent to the energy transfer regions 122 and 124.

The structure of FIG. 3A allows fluid and / or material in the central region to be supplied to the intended target area. The device may include a predetermined number of fluid ports 132 from a single fluid port or device to a plurality of circumferentially disposed ports or simply a limited port on a single side of the device. A variation of FIG. 3A illustrates a plurality of fluid ports 132 directed to direct fluid radially outwardly relative to the central axis of the single axis probe 105. One effect of locating the ports 132 proximate the energy delivery units is that the material can be delivered directly to the targeted tissue area during surgery.

3B illustrates another variation of the working end 104 of the device described herein. In this variation, the energy transfer regions 122, 124 are separated by a non-energy transfer region 130 and a fluid supply port 132, which is a hole in the annular passage in the port 105. [ FIG. 3B also illustrates that one or more sensor elements 126 may be installed between the energy transfer regions 122, 124. In certain variations, the sensor elements 126 will be located outside the flow path of the port 132, so that the material exiting the port 132 does not affect the reading of the sensor 1126.

Figure 3C illustrates an example of a device 100 positioned in tissue 10 where energy transfer regions 122 and 124 form lesions 12 within tissue 10. The figure illustrates applying an RF current 136 between the two regions 122 and 124, but as discussed above, the energy aspect may be a lesion or treatment region formed around energy transfer regions 122 and 124 The energy type can be applied to generate the energy 12. The illustrated example illustrates the state of the device 100 after the physician confirms the appropriate treatment location (e.g., after the stimulation mode identifies the appropriate treatment location). Figure 3C also shows the supply of material 134 through port 132. [ In the illustrated variant, the port 132 can supply material in a direction perpendicular or radially away from the probe axis 105. As described above, additional structures are within the scope of the present invention, including combinations of ports oriented to supply material in different directions on the same device. Nonetheless, the material can be supplied before, during or after the application of the therapeutic aspect. Moreover, placing the port 132 between or adjacent to the transfer regions 122 and 124 enables the target supply of material to the transfer region.

For example, it may be desirable to provide a numbing agent to the area in cosmetic applications. In such a case, once the physician determines the proper placement of the operative end of the device, the physician may supply the paralysis agent from the reservoir to the tissue area to be treated through the ports. Close proximity of the ports to the target area can minimize the amount of material to be supplied. Minimizing the amount and / or application of a paralytic agent is desirable because the paralytic agent can impair the nature of the muscle responsive to nerve stimulation.

As described herein, devices may include a predetermined number of energy aspects to provide therapeutic treatment. Thus, the energy transfer regions 122 and 124 shown in Figures 3A-3B are not limited to RF energy electrodes. In further variations, the regions may be selected from the group consisting of cooling zones, ultra-sluggish fluids, thermal RF, thermally heated regions of resistance, microwave antennas, concentrated or decentralized ultrasonic modulators, thermal surfaces driven by DC currents, They may include combinations thereof. In these variations, based on the wireless energy supply, the two energy transfer regions 122 and 124 may include electrodes of opposite polarity. Regardless of the type of energy used, it may be desirable to place the sensor 126 (or other sensor) between the transfer regions 122 and 124. Alternatively, or additionally, one or more sensors may be located along the probe 105 or in another part of the device.

Figures 4A-4G illustrate the use of the systems and devices described herein when used to perform treatment of a patient. The illustrated examples illustrate the use of device 100 for ablating a branch and / or one or more regions of a temporary nerve to control movement of the facial muscles. However, the methods, features, and aspects described herein can be applied to nerve structures that control observable / measurable bodily functions.

FIG. 4A is intended to illustrate the features of a similar system to a system in which the treatment device 100 described herein to operate in a dual target mode to provide nerve stimulation and therapy. In one variant, the stimulation function passes pulse dc between the energy transfer surfaces 122 and 124 of the working end 104 of the probe 105 to operate in the nerve stimulation mode. In a further variation, the nerve stimulation mode may provide an alternating current (or RF generating current) to identify the nerves through the muscle, as is known by one of ordinary skill in the art. Regardless, when used in the stimulation mode, the working end 104 of the device 105 applies current to the tissue to stimulate the nerves that produce movement of the nerve-controlled muscles. Such movement can be observed physically (e.g., by peeling for muscle movement) or visually (e.g., when a physician observes and stimulates which part of the face or which muscle has motion) . Moreover, any number of speed adjusting devices or camera devices may be used to detect movement.

The device 100 may operate in a plurality of settings that stimulate the nerve. If the working end of the device is close enough to the nerve, the distance depends on the applied current parameters (e.g., current amount or current amplitude). The cycle of current induces relaxation or contraction of other muscles that can be observed by the physician or sensing / confirming means. The amplitude of the current can be adjusted from the probe body or from the controller. The intensity of the stimulus is directly related to the amplitude of the current and the proximity of the motor neurons. As the physician approaches the nerve, he / she can reduce the amount of stimulus current and still observe muscle contractions. When the stimulation current is low (< 7mA) and muscle contraction is observed, the probe electrodes are placed close to the target motor nerve. In one working example, it was found that a low stimulus current (e.g., .7 milliamps) produced a nerve impulse within 2 mm of the working end of the device. Knowing that the device is within a certain nerve range, the system can apply the affecting energy within that range.

For example, in the current example, if the nerve / muscle is stimulated using critical stimulation energy (e. G., Low stimulation current) then the physiological and / or sensory verification means is operative to determine that the working end of the device is within the effective distance of the target tissue ), The therapeutic energy can be applied in a controlled manner without significantly surrounding the tissue beyond the target tissue or creating undesirable co-existing damage. In one variant, by stimulation with critical stimulation energy / current, the system can apply the stimulation energy while supplying the therapy energy and maintaining the defined target treatment temperature for a set period of time. The physician and / or the detection confirmation means will confirm that the effective treatment endpoint on the target tissue (i.e., nerve) has been reached. It is understood that the design of electrodes or treatment area or electrodes may also affect the extent of the device (lesion size, shape, volume, and isotherm). After positioning the motor nerve, the radio energy is applied through the same electrodes to heat the tissue and inhibit nerve function. When the RF lesion is placed in the nerve communication between the brain and the muscle, the muscle is inhibited and the patient can no longer operate the muscle.

Figure 4A shows the effect of two parameter settings in the stimulation mode. In the first parameter setting, the device 100 can stimulate the nerves of the tissue at the first distance 142. In the second parameter setting, the device 100 stimulates the nerve at the second distance. As shown in Figure 4A, the first distance is greater than the second distance. By such precision, a physician can generally operate the system in setting the first parameter to position the target nerve. To position the working end 104 of the device 100, the doctor changes to a second parameter setting and examines the ingestion and relaxation of the muscles controlled by the target nerve. As the stimulation range 140 of the device 100 is limited, it is confirmed that the stimulation of the target muscle brings the working end 104 close to the target site on the nerve. If the physician operates the device 100 in the second parameter setting and observes muscle motion, the physician will know that the working end is not optimally positioned for the nerve. Clearly, the system may include a predetermined number of parameter settings. Moreover, ranges 140 and 142 are for illustrative purposes only. In a working example, the second parameter setting is approximately 0.7 milliamperes and corresponds to a range 140 less than 2 mm. Again, parameter levels and ranges may be adjusted according to the application, tissue area, degree of need stimulation, and so on. In another variation of the device and system, unless the device is returned to the second parameter setting corresponding to the smaller stimulus range 140 by the controller / power supply (and / or the characteristics of the device 100 itself) Is prohibited from operating in the treatment mode.

In yet another variation, the system may provide a warning to the physician that the application of treatment is not prohibited, but is not in a preferred mode for applying therapy. Thus, the system may request the physician to override the director so that he or she can perform the therapist therapy purposefully.

4B illustrates an access point 20 and a temporary nerve branch 14 that the physician advances the probe 105 of the device 100 to position the subcutaneous probe adjacent the target nerve. As described herein, variations of the present invention may use a single axis probe to minimize entry damage 20 and accurately track along nerve 14. In alternative variations, the multi-axis probe may be used with the accuracy of the variable parameter as described herein.

4C illustrates the working end 104 of the device being advanced through the access hole 20 towards the nerve 14. As shown, the device may operate in the first parameter setting, so that the stimulation distance 142 is sufficient for the physician to position the nerve responsible for the particular muscle. The hole 20 is not limited to the position as illustrated. The probe is accessible to any part of the body as needed.

During the probe placement process, the stimulation current level can be increased or decreased as described by pressing one or more switches on the device in succession (see FIGS. 1 and 2 above). The speaker coupled to the system may emit a tone having a volume or frequency or other sound and / or visual component that is substantially proportional to the amplitude setting of the stimulating current due to the closure of each switch. This feature allows the practitioner to adjust the stimulation level without having to adjust any level dials or switches associated with the generator, allowing the practitioner to focus on an important probe placement.

In one variant, as the physician positions the nerve 14, the physician may adjust the system to a second parameter setting, thereby reducing the stimulation range 140. As illustrated, the stimulation of the nerve 14 when in the second parameter setting tells the physician that the energy transfer portions of the working end are close enough and immediately adjacent to and / or in contact with the predetermined target area 30.

4D shows the reduced stimulus range 140 as the device operates in the second parameter setting. Observing the muscle movement, the physician may enter the treatment mode of the system by activating a switch that applies therapeutic energy / therapy (as described above) without moving the device. Once in the treatment mode, the physician can ablate or otherwise treat the target area 30. As described above, since the stimulation of the target nerve occurs when using the threshold current, the system can be used by applying a predetermined amount of therapeutic energy to the tissue that has a known effect (by controlling for a certain temperature and / or time as described above) ) The system can perform neurological treatment. In certain variations, a predetermined amount of energy is certainly set such that the treatment effect does not occur beyond the critical stimulus range of the device (i.e., the threshold energy, e.g., the range of devices when using range 140 of FIG. 4A) .

In a further variation, the system can treat the target area 30 using settings that cause muscle contraction or irritation during therapeutic application of energy. Thus, the physician can observe stimulation of the involved muscles during treatment. In such a variant, the physician can confirm the treatment when the associated muscle stops exercising. Muscle spasms are believed to occur when the nerves supplying energy to the muscles are deactivated. If the frequency is low enough (e.g., 60 Hz), the nerve is directly deactivated.

4E shows the physician advancing the working end 104 along the nerve 14 through the same aperture 20 and also shows a larger stimulation range 142 (as opposed to a reduced stimulation range 140 of the second parameter setting) ) ≪ / RTI > automatically resets or switches the device and / or the controller / power supply with a first parameter setting corresponding to the first parameter setting. As described above, in certain variations, when the system is in the first parameter setting, the system inhibits the use of performing a therapeutic action. In certain variations, the system may apply a remedial action only when in the second parameter setting. One advantage of this feature is that the physician who moves the device from the first treatment site 30 toward the second treatment site 32 has an energy transfer surface of the working end in the intended nerve and / To ensure that the parameter settings are readjusted to the first parameter setting to ensure proximity. FIG. 4F illustrates a device 100 in which a physician reselects a second parameter setting corresponding to a reduced stimulus range 140. Once the physician places the device through identifying the relevant muscle movements, the physician can apply the remedial action without moving the device. As shown, the second position 32 follows the imaginary longitudinal axis of the nerve away from the closer position 30. Such " near-to-distal " resection along the longitudinal axis of the nerve is believed to enhance the treatment-sustaining effect.

FIG. 4G illustrates a variation of the treatment process in which the physician identifies and generates treatment at three locations 30, 32, 34. For clarity, by way of example, the working end 105 is retracted through the access point 20. By way of example, it also illustrates the salient features of a dual-purpose probe that provides the ability to generate multiple lesions (30, 32, 34) in the same nerve or in a nerve region that controls one or more muscles that require treatment . In the illustrated example, the physician creates an initial lesion 30. This early lesion interferes with communication to the nerve, but the nerve portion from the lesion 30 to the muscle (indicated by region 22) is still intact. By virtue of these nerve impairments, the physician can perform the stimulation function of the probe to further stimulate the motion of the muscle region 22 by moving the probe in the distal direction (i.e., in a direction closer to the muscle region 22 along the nerve) You can continue to use it. The motion of such a device allows the physician to accurately reposition the device on the same nerve (or other nerve branching part that controls the muscles requiring treatment). While the probe tip moves away from the initial lesion along the nerve (toward the muscle), the surgeon can position the nerve through stimulation and observation as described above. In the illustrated example, lesions are generated in three consecutive processes and the initial lesion 30, the next lesion 32, and the final lesion 34 are formed in series. The more distant the probe is from the final lesion by the stimulation mode, the more muscle contraction occurs.

Relocating nerves and applying multiple lesions to a single nerve can be applied to ensure long-term therapeutic effects. Many lesions along the same nerve (or the same nerve area) increase the lifetime of the effect that occurs because the nerve must be treated at three positions before it can relay the signal. Because nerves are believed to be treated at the proximal to distal site, it is believed that multiple lesions support the duration of treatment continuity. Treatment of the nearest neuronal injury site (e. G., 30) implies that communications can be reconstructed along the nerve prior to treatment of the more distant site of neuronal damage 32 or 34. [

In another variation, as shown in Figures 4A-4G, a method of generating multiple lesions on the same nerve includes an external stimulation device and a map nerve position to obtain a schematic representation of the nerve location. The physician then inserts the probe or device probe into the tissue. The physician then uses the stimulus function to locate the target nerve. In variants, the stimulus function is automatically set to a parameter setting that increases the stimulus range of the device but also prevents the device from burning the treatment / ablation measure. The physician will then adjust the stimulation current to pinpoint the nerve and confirm muscle contraction. If the stimulation parameters are set to reduce the stimulus range of the device, the physician will observe the placement of the probe through observation, and the physician can then initiate the treatment mode of the device (e.g., Applying energy to affect performance, or ablating nerves / manipulations). In some variations, the system will automatically reset to the first parameter setting, which increases the stimulus range of the device and prevents the device from being activated in the treatment mode. Next, the physician will randomly advance the probe to a new location away from the initial lesion and repeat the stimulation and treatment. The physician may repeat the follow-up treatment along the nerve as needed to create the desired number of lesions.

Variations of the device include at least three parameter settings wherein the two parameter settings correspond to a much smaller stimulus range than the third parameter setting. In such a case, the two reduced parameter settings correspond to the first acknowledgment range and the second, smaller range. With such a setting, the physician can position the device with respect to the nerve with variable precision.

5 illustrates yet another feature of the heterogeneous functional device 100. As shown in FIG. In this variation, the fluid port located in the device supplies material 134 between the treatment portions 122 and 124 of the device. In this example, the material includes an anesthetic or paralytic agent (as exemplified by the obtuse portion of FIG. 5) to produce a limited effect area 44. One advantage of this structure is that application of a paralytic agent over a larger area can impair muscle stimulation of the nerve. Thus, if paralysis affects the nerves and can no longer initiate muscle movement, or neural areas away from the first treatment site can not be stimulated, the effectiveness of the surgery is impaired. Modifications of the process include supplying the paralytic agent before, during, and / or after the therapeutic application step. In some cases, it may be desirable for the patient to maintain autonomic control of the muscles to be treated, as the physician may require the patient to constrict the muscles. By contracting the muscles, the doctor can decide on the progress of the treatment. In such a case, it may not be desirable to cover the face or muscles with anesthetics because the patient can not contract his / her muscles. Examples of paralytic agents include 1 or 2 percent of dilute lidocaine, lidocaine with epinephrine, and streptomycin. However, any paralysis can be used.

6A and 6B illustrate various additional examples for generating a treatment site to generate treatment benefits. Figure 6A illustrates the proximity of a nerve having a second 32, third 34 and fourth lesion 36 on separate branches of the nerve 14 or a first lesion 30 on the main branch do. As described above, the order of ablation sites is based on the direction of the proximal direction (e.g., away from the insertion point, or toward the muscle). 6B shows a treatment example of a plurality of lateral nerve branches. As shown in Figure 6B, a modification of the process involves applying a lesion to the " lateral " branches of the major nerve proximate to the muscle. The desired effect of inhibiting nerve function is thus achieved by removing a hyperactive facial line (wrinkles) caused by muscle activity by applying a single lesion to the multiple nerve branches of the temporary nerve. The first lesion 30 is located farthest from the target muscle proximate to the access point 16 and the second lesion 32 is located farther from the first lesion 30 and is located farther from the target lesion 32 than the third lesion 32, Is formed away from the second lesion 32 and each lesion is at another branch of the temporary nerve 17.

6C illustrates still other examples of lesions 30 created in the stiff nerve in the manner described herein. As described above, the methods and devices of the present invention can be produced along a large number of nerves in a predetermined number of areas of the body.

Figure 7: Alternate variations of Bi-polar Driver System

Figure 7 identifies two required components of the system, several modules, and optional elements. The two components used during the process will always be the energy generator / controller / data storage device 400 and the probe 371 and the device 400 can recognize the appropriately designated probe and prevent reuse of previously used probes , An enhanced electronic system capable of generating the appropriate energy already described, performing safety checks, storing data, and performing other functions as described. The main functions of the device 400 may include, but are not limited to, generating light, generating position-stimulating currents, generating ablation energy, data logging, storing, communicating and returning, and other functions essential to the MIS process . The probe 371 and its various forms are single perforated bipolar tools that can be used to identify the proper location of the tip 301 in association with the target tissue 101 to be resected, deformed or destroyed. The probe 371 and its various derivatives may optionally be used to position and properly position the tip 301 of the probe 371.

8A and 8B: Schematic Schematic of Bipolar Probes

The bipolar probe 310 displays the probes 371, 372, and 373 shown in Figs. 9A-9C except for the shape of the peak on the probe. Figure 9D differs from the others because it has a split return probe. The bipolar probe 310 (not shown in scale) includes an insulating dielectric 309 made of a suitable bioactive material, such as Teflon, PTFE or other insulating material, and a covered electrode 302, . The conductive return electrode 302 tube is made of medical stainless steel, titanium, or other conductive material. A hollow or solid conductive tip electrode 301 protrudes from a surrounding dielectric insulator 305. The dimensions (diameter, length, thickness, etc.) of the sizes of the lumens 309, 302, 305 and 301 and their inner lumens can be adjusted to allow different surface areas and produce a non-current density as required for specific therapeutic applications .

The hollow electrode 301 is often used as a drug supply syringe, such as a local anesthetic. The tip electrode 301 is connected to the power amplifier 416 via an impedance matching network 418 (Fig. 10). The return electrode (s) 302 provide a return current to the power amplifier 416 via the impedance matching network 418. In the disclosed embodiment, the dielectric insulator is made of a transparent medical polycarbonate that functions as a light pipe or fiber optic cable. The light source LED or laser 408 (FIG. 10) provides illumination at the distal end of the probe through the fiber optic cable / transparent insulator 305 for guiding the probe under the skin, i.e., for shallow surgery. In an alternative embodiment, the dielectric insulator is replaced with a plurality of optical fibers for illumination and viewing, as shown in Fig. 12A.

The ablation regions 306 and 140 extend radially about an electrode 301 that generally follows an electric field line. There is a possibility of burning in the area 306 very close to the skin 330 for the procedure. To minimize the possibility of combustion, a split return probe 374 shown in Fig. 9D is provided. Thus concentrating the current away from region 306 to region 140 or vice versa. 8A, the insulator 307 divides the return electrode into two sections 302 and 303 and divides the return current ratio by 0-50%, which can also be selectively activated. The active electrodes are also divided into two sections 301 and 311 so that energy can be directed in a certain direction. This electrode structure is identified at the proximal portion of the probe and thus the operator can position the needle and electrode accordingly. Figure 12A teaches laser ablation for more precise energy delivery.

8A: Isometric View of Split Bi-Polar Probe < RTI ID = 0.0 >

The bipolar probe 380 (not shown in scale) consists of an insulating dielectric 309 made of a suitable biologically inert material, such as Teflon, PTFE or other electrical insulating material covering the split return electrodes 302 and 303 . The disclosed conductive return electrodes 302 and 303 are made of medical stainless steel, titanium, or other electrically conductive material. Electrodes 301 and 311 of conductive tips that are hollow or solid protrude from surrounding dielectric insulator 305. The operation of the hollow / segmented conductive tip is similar to the probe tip 310 shown in FIG. 9D. The cut-off regions 1203 (FIG. 10) and 140-144 extend generally radially about the electrode 301 along the electric field lines. There is a possibility of burning in the area 306 because it is very close to the skin 330 for the sake of the procedure. In order to minimize the possibility of combustion, the divided return probe 311 shown in FIG. 9D is used, so that the current is concentrated away from the region 306 to the region 140. In the case of a procedure in which there is a risk for the adjacent structure 111, the cutout region 1203 should be a cutout region that is not a radial direction. The divided electrodes 380 can divide or separate the energy supplied to the electrode pairs 301/302 and 311/303.

The disclosed breakdown or ratio between pairs is 0-100%. A dual amplifier or a multiplexing / switching main amplifier 416 located between the electrode pairs avoids the structure 111 and directs energy to the target 101. This simple switch network reliably distributes electrical energy while minimizing damage to adjacent structures.

9A: Conical Bi-Polar Needle

The bipolar probe 371 discloses a tip 351 and conical electrode 301 for minimally invading single point entry. The probe diameter 358 is similar to a 20-gauge or other small gauge syringe needle, but may be larger or smaller depending upon the application, the surface area required, and the required penetration depth. In the disclosed embodiment, the electrode shaft 302 is 30 mm long, approximately 5 mm uninsulated. Both the length and surface area of both can be modified to meet various applications such as cosmetic surgery or removal of back pain. The conductive return electrode 302 is made of medical stainless steel, titanium, or other conductive material. In the disclosed embodiment, the dielectric insulator 305 is made of a transparent medical material, such as polycarbonate, which can perform dual action as a light pipe or fiber optic cable. A high illuminance light source 408 LED / laser (FIG. 10) provides guidance illumination 448 at the working end of the probe. The illumination source modulation / flash speed is proportional to the received stimulation current 810, as in FIG. 8. Small diameter electrodes permit minimal invasive surgery that is typically performed with local anesthetics. Such a structure may include lumens for the supply of the formulation as otherwise described.

9B: a hollow chisel (Chisel)

The hollow chisel electrode 352 is often used as a syringe to supply pharmaceuticals such as local anesthetics, medicines / trace dye. The hollow electrode can also extract the sample. In the disclosed embodiment, the dielectric insulator 305 is a transparent medical polycarbonate and functions as a light pipe or fiber optic cable. The new dual purpose dielectric reduces the probe diameter and reduces manufacturing costs. A light source 408, typically an LED or laser (not shown in FIG. 10), provides illumination 448 at the working end of the probe. This provides an illumination source for guiding the probe under the skin. As shown in FIG. 12A, in the second embodiment, the dielectric insulating material is replaced / combined with a plurality of optical fibers for visible / illumination.

9C: Tapered Conical < RTI ID = 0.0 >

The bipolar probe 373 discloses a tapered conical probe for minimally invasive single point entry. And is configured similarly to the probe 371 as shown in FIG. 3A. The probe tip is not shown in scale to illustrate the tip structure. In the disclosed embodiment, the electrode 301 is approximately 5 mm long and may be manufactured in various sizes to meet specific application and surface area requirements. The electrode 353 of the solid tapered conductive tip protrudes from the tapered dielectric insulator 305. The transparent dielectric insulator 305 also functions as a light pipe or fiber optic cable connected to a high illuminance light source 408 (FIG. 7) that provides illumination 448. The electrode assembly is mounted to an ergonomic handle 388 (not shown in size). The handle 388 has a cut-off run / stop switch 310, a cut / strike mode switch 367, an identification module 331, and a cable terminal 1334 (FIG. 7B). A temperature sensor 330 (close to the tip) monitors the tissue temperature.

9D: Split Conical Bi-Polar Probe < RTI ID = 0.0 >

8B and 9D, the details of such a probe will be described. The bipolar probe 374 (not shown in scale) consists of an insulating dielectric 309 made of a suitable biologically inert material, such as Teflon, covering the split return electrodes 302 and 303. Conductive return electrodes 302 are made of medical stainless steel, titanium or other suitable conductive material. The hollow or solid divided conductive tip electrodes 301 and 311 protrude from the dielectric insulator 305 around it. Their operation is similar to probe tip 380 as taught in Figure 8A. The solid tapered conductive tips 311 and 301 protrude from the transparent dielectric insulator 305. The dielectric insulator 305 also functions as a light pipe or fiber optic cable connected to a high illuminance light source 408 that provides illumination 448.

A probe handle (not shown in scale) surrounds the memory module 331, the switch 310 and the mode switch 367. The temperature sensor 330 (located close to the tip) monitors the tissue temperature. The divided electrodes 380 (Fig. 8A) can separate and divide the energy supplied to the electrode pairs 301/302 and 311/303. A dual amplifier or time multiplexing / switching main amplifier 416 is located between the electrode pairs to direct energy to the target 101, avoiding the target 111 and create an asymmetrical ablation volume. Small diameter electrode needles are implanted from a single entry point, minimizing damage and simplifying correct electrode placement.

The connection portions consist of a tapered dielectric sleeve 309 covering the protruded stainless steel electrode tube 302. Insulation sleeve 309 is made of a suitable biologically inert material, which covers electrode 302. The dielectric insulator 305 insulates the electrodes 351 and 301 of the conical tip.

11A: Ablation step (no auxiliary probe)

The ablation probe 371 is inserted and automatically guided to the area (box 531) where the target nerve to be ablated is located. A test current 811 is applied (box 532). If the probe is placed in close proximity to the medial target nerve, a physiological response is detected / observed (e.g., muscle irritation of the forehead will be observed during removal of the intervertebral indentations). Once the response is observed, the skin surface may be optionally labeled to subsequently locate the nerve region. Power is applied as an attempt to excise the nerve (Box 535). If no physiological response is observed (box 534), the probe will be repositioned closer to the target nerve and the stimulation test will be repeated (boxes 536 and 537). If no physiological response is observed, the procedure may be terminated (box 544). In addition, the probe can be moved up, down, close, far, circle, in a pattern, or any direction, creating a wider cutout area for more permanent results.

At box 537, once the stimulus is again observed, the ablation power can be set higher (box 538) and, instead, as described, the needle can be moved in various directions, or signal conduction through the nerve A greater amount of energy can be reapplied to form a larger ablation area for a more effective or more permanent termination of < RTI ID = 0.0 > After powering up (box 540), stimulation energy may be applied again (box 541). If there is no stimulation, the operation is terminated (box 544). If there is still signal flow through the nerve (stimulus or physiological response) then the probe is repositioned (box 542) and surgery is resumed (box 533).

Figure 11B: Flow chart of visually guided ablation surgery using ancillary probes such as probes 771 and 772

The auxiliary probes 771 and 772 (FIGS. 13A and 13B) provide a method for quickly and accurately positioning the target structure 101 and subsequently displaying the target location 755. Auxiliary probes can be smaller than ablation probes (like acupuncture needles). The structures are typically marked with ink or similar pens so that the ablation probe 371 illuminated with the mark 755 or another ablation probe can be quickly guided. Optionally, a non-illuminated probe can be used and allows the practitioner to simply feel the probe tip. For a deep structure, the probe 771 (Fig. 8) can be used as an electronic beacon. A small current 811 from the smaller probe tip 702 is used to guide the ablation probe 372 (Fig. 8), similar to the excitation current.

The auxiliary probe 771 or 772 (Figures 13A and 13B) is inserted through the muscle layer (s) 710 and the skin 330 near the nerve 101 by operation 530 (Figure 11B). Depth 766 of target 101 is measured using an auxiliary probe mark 765 (Figs. 13A and 13B). The decision 533 checks whether the adjustment is to be performed (534) and whether the probe is in place. The nerve stimulation current 811 is activated by operation 532. [ When a stimulus is obtained or a physiological action is obtained, the auxiliary probe tip is in place. The depth may be indicated by the read mark 765 and the position mark 755 may be produced at act 535. [ At act 536 and 537, the probe under the mark is in place, setting power level 404 at act 538 and closing resection switch 410. Alternatively, stimulation may be applied directly from ablation probes as otherwise taught. The operation 540 and the controller 401 set the frequencies of the generator 411 (FIG. 7), and the cover of the modulator 420 operates the power amplifier 416 to supply the set resection energy. The region 1203 (FIG. 10) shows the general shape of the cutout region for the conical tip 301, for example.

Between each ablation, surgery 540 (Fig. 11A) (nerve conduction) was tested in box 541. The probe amplifier 416 supplies a small nerve stimulation current 811 from the electrode 301 or the auxiliary probe 771 or from both sides. Based on the nerve conduction test 541, the operation is terminated when a predetermined level of conduction is achieved. Operation 542 moves the probe to the next position and repeats the conductivity test 541. Upon termination, the probe (s) are removed at operation 544. Recovery and ablation strength / energy are set by special operation and predetermined performance. The practitioner selects the surgery / power level 404 (FIG. 7) and the controller 401 compares the probes loaded through the verifier 331 (FIG. 7) for consistency with the selected surgery. If the mounted probe does not match the selected power range 404, the operator is alerted.

By way of example, and not by way of limitation, five ablation regions 140, 141, 142, 143, and 144 are shown in FIG. The ablation begins at region 144, and then the probe moves to region 143 and to region 140 and so on. Alternatively, the movement may be during insertion, and may be transversally, circularly, or otherwise moved to enlarge the destructive region of the target nerve. The nerve response can be tested after each resection, thereby allowing the practitioner to immediately examine the nerve conduction level. Probe position and power adjustments are made before applying additional ablation if necessary.

The exact probe location tools and methods taught herein allow the use of minimal ablation energy and minimize damage to structures that are not targets. This reduces healing time and minimizes patient discomfort. The present invention provides a new tool for performing minimally invasive nerve conduction while limiting surgery with the ability to select temporary or permanent nerve conduction disorders as a new level of confidence to the practitioner. These new tools provide low-cost surgery routinely performed in offices or outpatient settings that typically require less than an hour by local anesthetics. Compared to the prior art where surgical surgery requires rest, this new tool has longer healing intervals with limited persistence control (nerve regrowth).

The sub-probes 771 and 772 (Figs. 13A and 13B) have a precisely located target structure 101 and subsequently displayed target positions 140-144. The shallow structure can be marked with an ink pen 755 so that the illuminated ablation probes 371, 372 or even can be quickly guided to that point. In the case of a deep structure, the probe 771 is used as an electronic beacon and a small current 811 from the probe tip 702 is used to guide the ablation probe 372 as shown in FIG.

The ablation probe 372 is inserted through the skin 330 and the muscle layer 710 near the nerve 101 and by the illumination source 408 the operator can quickly and accurately illuminate the ablation probe 372 Location. Illumination 448 from the ablation probe shown by practitioner 775 is used as an additional support in depth assessment. A selectable nerve stimulation mimic current 811 supports the location of the nerve 101 within the region 1204. This new probe installation system gives the operator confidence and the system works precisely to allow the operator to focus on precise surgery. Accurate probe position allows the use of minimal energy during ablation, maximizes damage to non-target structures, and reduces healing time and patient inconvenience.

Region 1203 shows the general shape of the ablation zone for conical tip 301. [ The tip 301 is placed in close proximity to the target nerve 101. Ablation usually requires a series of localized transfers. The number of ablation and intensity / energy are set by the specific surgery and the required performance.

Five ablation regions 140, 141, 142, 143, and 144 are illustrated; However, there are some more areas. Ablation begins at region 144 and then the probe is moved into region 143 and into region 140 and conversely the ablation begins at region 140 and moves to region 144. [ In addition, the practitioner can perform rotational motion, thus increasing the ablation area and the surgical performance. Between each ablation operation 540 (Fig. 5C), a small nerve stimulation test current 811 is emitted from the electrode 301. The approximate effective range of the nerve stimulation current 811 is indicated by 1204. By testing the nerve response after each resection, the practitioner can immediately check the nerve conduction level. Without removal of the probe 372, the practitioner accepts immediate feedback on the quality of ablation. Subsequently, small probe position adjustments are made before performing additional ablation (if necessary).

Figure 10 illustrates another example of a system for use with the methods and processes described herein. First, the probe electrode 301 is positioned at a predetermined position with respect to the target nerve 101 (FIG. 10), and then the user uses the selected power setting 404 (FIG. 10) Start treatment. The practitioner constructs the generators 411 (FIGS. 10 and 412) to match the amplitude frequency and modulation envelope and provides 5 to 500 watts and 50 kHz to 2.5 MHz of available energy. The summing junction 413 combines the RF outputs as required by the application and provides them in combination to the pulse-width modulator 415 for output power control. The output of modulation generator 420 is applied to multiplier 415 with radio frequency (RF) signals 422 and 423. This results in a complex energy profile being fed to the time-varying non-linear bioburden. All these settings are based on the information provided to the generator by the installed probe 371, the selected power supply 403 setting, and the modulation generator 420 (FIG. 10) settings, which are then supplied by the generator 421.

For example, the high amplitude sinusoidal wave 910 (Fig. 15) used for cutting and the pulse width modulated (PWM) sine wave 920 used for coagulation are well known in the electrosurgical art. The precise power rate and average total power limit are controlled through an integrator 435 that minimizes the burning or damage of nearby structures close to shallow surgical skin. 8B) can not be avoided by the electrodes 371 (Fig. 9A) and 372 (Fig. 9B) in close proximity and additional probe features as taught herein may lead to energy and lead to smaller Leading to additional ways to limit ablation to the region, avoiding other structures. For safety reasons, a wire-connected switch 436 interrupts the power amplifier in the event of a system malfunction, and the probe is unplugged or overloaded, thus protecting both the patient and the operator.

The output of the modulator 415 is applied to the input of the power amplifier 416 portion. The output of the power amplifier 416 is then fed to an impedance matching network 418 which provides a dynamically controlled output to a highly variable and nonlinear biological load and requires dynamic control of both power level and impedance matching do. The switching of the matching network 418 is performed for optimum power delivery to the probe, the power level, and the set treatment frequency. The peak power of the system is 500 watts in this disclosed embodiment. Precise control is formed by the proximity of the tip and control loops contained in the generator itself. The final energy generator 420 is supplied to the probe tip 301 and the return electrode 302.

Directed Ablation

In addition to the substantially radially-symmetric ablation patterns with probes as taught in probes 371 (Fig. 9A) and 372, the conversion or split resection power supply to multiple electrodes (Fig. 9D) Lt; / RTI > A high illuminance source 608 (FIGS. 12A and 12B) with probes 610 minimizes damage to adjacent structures 111 or burning of skin 330 in shallow surgery. Figures 8B and 9D also identify probe structures for selective or asymmetric ablation.

Power Feedback

The power amplifier output 430 and the buffered feedback signal 437 may be coupled to an analog to digital converter (or ADC) for processor analysis and control. The signals 437 control the power modulator generator 420 setting and impact the impedance match control signal 419. This integrated power signal 437 is then recorded in an operating-condition database (FIG. 16A) for review of the operation. This power supply level is also compared to and exceeded the readings taken from the probe 1492 (Fig. 16B) relative to the process maximum value, which again stops the amplifier output and protects the patient from errors or facility malfunctions. Similarly, limitations from generator sensors and probes, such as temperature 330, can be used to arbitrarily modulate the power level and ultimately to terminate or substantially reduce the operation.

The controller described herein may also identify a selected operation 1415 (FIG. 16A) as to whether it conforms to the mounted probe. If not, the user also tries to select a different power setting 404, surgery, or probe 371. When the probe 371 coincides with the power setting 404, the system activates the power amplifier 416, the guide light source 408, and the low voltage neural simulation 732. All of these surgeries are performed by mandatory "hand shake" protocols and serial information, which must be adequately verified by the surgical electrical circuit to be present and to be configured.

During clinical surgery, it is necessary for the information to be conveyed by the internal electronics contained within the probe, which provides another way of implementing such protection and prevents unauthorized reuse. The ultimate goal is to prevent cross-contamination between patients. The probe will achieve this by a special, continuous, and provided procedure.

Once connected, the probe will write serial numbers to the data logging system via the serial bus 403 and the logic circuit will prevent re-use and cross-contamination of the probes that may occur thereafter. Moreover, the program will prevent the use of unauthorized third party probes because the probes are not running, which can be of poor quality and prevents unauthorized probing from being used and risking the patient.

Optical Probe Guidance (Optical Probe Guidance)

The disclosed invention provides an optical source 408 that supports the probe arrangement (Figure 17) by replenishing the stimulation source 732 and acting as a preliminary guide. The probe 771 is selectable between current measurement 811 measurements from the neurostimulator or the auxiliary probe tip 702 or to the component. Ablation probe switch 367 selects a low-energy stimulator / receiver or high-energy ablation from probes 371, 372, 373, and 374. In this mode, the physician operator would have already marked the mark 755 on the skin surface by various means as described. The physician operator 775 then monitors the tip 448 to see if the optical illumination is activated. The tip 448 will provide a spot of light below the skin indicating the position of the tip relative to the mark 755. The physician 775 will then guide the probe tip 301 to the correct alignment below these marks 755 to ablate the target tissue 101.

Alternative probe structure

19 is a schematic diagram of an alternative embodiment of a single axis electrosurgical probe 2000 having a longitudinal probe axis 2001, similar to the probe described above. However, the probe 2000 of FIG. 19 features conductive electrodes 2002 and 2004 of substantially equal surface area located along the longitudinal axis. A probe 371 having electrodes 301 and 302 of substantially uniform surface area is also shown above.

In an embodiment of equal electrode surface area, one of the conductive electrodes 2002, 2004 may be selectively connected to a stimulating current source or a cut-off current source as described above. Other electrodes 2002 and 2004 may or may not be connected as the ground or return path of the connected current source. In the embodiment shown in Fig. 19, the conductive electrode 2002 is configured to be connected to the excision source forming electrode 2002, which is an active electrode. Thus, electrode 2004 is the return electrode in this embodiment. By suitable switches, the electrodes 2002 and 2004 can be connected to a current source or return line.

Since electrodes 2002 and 2004 have a substantially uniform surface area, the localized heating formed when RF ablation energy is applied to active electrode 2002 results in a heating zone having a substantially symmetrical elliptical shape.

The single axis electrosurgical probe 2000 of FIG. 19 also features a dielectric insulator 2006 positioned along the probe axis between the conductive electrodes 2002 and 2004. The gene insulator 2006 has a predetermined suitable length, and probes with insulators of an alternate length can be manufactured for special resection operations. Changing the length of the dielectric insulator 2006 changes the gap dimension 2008 between the electrodes 2002 and 2004. The change in the gap dimension 2008 optimizes the current density in the ablation zone, changing the length of the ablation zone, and allowing a higher contact pressure to be used if necessary. As such, the gap dimension can be selected in conjunction with other parameters such as electrode surface area and rescue current to achieve a selection of ablation volume and tissue temperature for a particular application.

The probe 2000 of FIG. 19 also features a conical tip 351, a wave-resistant tip 352, or a blunt tip 2010 than other types of tips, as described herein. The dull tip 2010 of Figure 19 is effective in certain instances so that it has a flexible rounded profile and can be manipulated under the skin while the probe can easily advance and minimize the risk of cutting or perforation of adjacent tissue or skeletal structures. Similarly, a dull tip (2010) will significantly reduce bruising and other mental trauma during surgery.

The probe 2000 of FIG. 19 may include a sensor 2012. The sensor may be a temperature sensor. The temperature sensor provides active temperature monitoring within the ablation zone. Alternatively, a single-axis electrosurgical probe of a given configuration may be implemented as a Kalman filter as taught by Conolly, U. S. Patent No. 6,384, 384, incorporated herein by reference in its entirety. The Calman filter is also used to evaluate tissue temperature within the excision volume. The Calman filter is suitable for use when the well-defined tissue state changes at a certain temperature due to porotene denaturation, such as denaturation of collagen at 65 degrees. Calman filter temperature monitoring is effective because space and cost of separate temperature sensors are avoided.

20 is a schematic diagram of an asymmetric single-axis probe 2014 that also defines a longitudinal probe axis 2015. Fig. The probe 2014 is characterized by a first conductive electrode 2016 and a second conductive electrode 2018 having different surface areas. In the embodiment shown in FIG. 20, the first electrode 2016 is an active electrode and the second electrode 2018 having a larger surface area is a return electrode. Probes having a predetermined surface area ratio between the active electrode and the return electrode may be fabricated and used to achieve specific resection results. Additionally, the relative positions of the active electrode 2016 and the return electrode 2018 with respect to the tip of the probe may be reversed. In one embodiment, the ratio of the active electrode 2016 to the surface area of the return electrode 2018 is 1: 3. Other ratios including 1: 8 may be implemented to achieve a particular result. The surface area ratio may be adjustable using a sleeve or other mechanism to cover or block some or all of the electrodes and thereby increase or decrease the length of the gap forming the dielectric material 2019. [ Generally, the asymmetric electrode surface area results in asymmetric heating and ablation due to the higher current density of the RF ablation energy at the electrode with the smaller surface area. For example, when RF energy is applied to the active electrode of the embodiment of FIG. 20, the tissue volume adjacent to the active electrode 2016 is heated asymmetrically due to the greater current density resulting from the relatively small surface area of the active electrode 2016 . Asymmetric tissue heating combined with precise RF power integration as taught herein and the ability to create repeatable and controlled ablation volumes selected by various probe configurations.

FIG. 21 schematically illustrates an alternative asymmetric probe 2020, which is similar to the asymmetric probe 2014 of FIG. 20 in many aspects. However, the asymmetric probe 2020 of FIG. 21 is characterized by the active electrode 2022 having a surface area that is larger than the surface area of the return electrode 2024. 21, the current density is higher in the relatively small surface area electrode 2024, so that the ablation energy is closer to the electrode 2024 and to the distance between the electrodes 2022 and 2024, Gaps 2025. In this way,

FIG. 22 is a schematic diagram of one embodiment of a plurality of electrode probes 2026. FIG. The probe 2026 of the plurality of electrodes includes a substantially needle-shaped probe body 2028 forming a longitudinal probe axis 2029. Two or more electrodes are associated with the probe body and located at various locations along the probe axis. In the embodiment of FIG. 22, the electrodes include an active electrode 2030, a return electrode 2032, and a stimulating electrode 2034. In this embodiment, the active electrode is positioned near the tip of the multiple electrode probe 2026, the return electrode 2032 is positioned away from the tip and the makeup electrode 2034 is positioned between the active electrode 2030 and the return electrode 2032 . It is clear that the positions of the various electrodes relative to each other and the tip can be varied to achieve special ablation and probe placement advantages. Furthermore, the connection of certain object-like electrodes as the active electrode, return or stimulation electrode may be altered by a simple diversion mechanism between the electrode and the ablation or excitation energy source, depending on the user's discretion. Alternatively, a separate ground or return path 2035 may be utilized by certain electrode structures. The multiple electrodes of the multiple electrode probes 2026 are separated by a first dielectric insulator 2036 and a second dielectric insulator 2038. FIG. 23 schematically illustrates a multi-polar probe 2026 of FIG. 22 that adds a curved section 2040 opposite a portion of the probe body 2028 associated with the electrodes. By curved section 2040 again, in some cases the practitioner can achieve optimal probe placement with minimal unnecessary tissue damage. The multiple electrode probe 2026 may be implemented with various dimensions of dielectric insulators 2036, 2038, other surface area sensors or electrodes to achieve the desired ablation results, all as described above.

23-25 schematically illustrate an alternative embodiment of a probe 2042 of multiple electrodes. The probes 2042 of the multiple electrodes of FIGS. 23-25 include a probe body 2044 forming a longitudinal probe axis 2045. Multiple electrodes 2046-2062 are coupled to probe body 2044 at discrete locations along the probe axis. 23-25. In the illustrated embodiment, the electrodes are of uniform size and spacing. However, it is important to note that the different sizes of the electrodes and the non-uniform spacing of the electrodes can be implemented to achieve special resection results. Preferably, each electrode 2046-2062 may be selectively connected or disconnected by one or more switches to a stimulating current source, a cut-off current source, a ground of the stimulating current source, and an ablation energy source ground. As described in more detail below, the flexibility provided by the switched connection of each electrode to a current source or ground provides certain advantages in probe location and ablation. Moreover, the probes 2042 of the multiple electrodes can be unfolded in association with a separate return electrode 2064 typically disposed in contact with tissue away from the ablation site.

Placement Methods

Several methods of appropriately positioning the probe adjacent to selected neurons to apply ablation energy have been described above. For example, probe placement methods featuring fluorescent marker dyes, optical probe guidance and electronic probe guidance using low energy nerve stimulation currents are described in more detail. Certain alternative probe structures as illustrated in Figures 19-25 provide fine probe placement using variations of the basic electrical stimulation technique as described above.

The single axis electrosurgical probe 2000 of FIG. 18 or the asymmetric probes 2014 and 2020 described herein can be appropriately positioned using repeating techniques as described above with respect to FIGS. 11A-C. The iterative placement method can be calibrated for use with probes of multiple electrodes as shown in Figures 16-20.

In the probe embodiments in which the stimulating electrodes are located between the resection electrodes 2030 and 2032, the target nerve is positioned between the active electrode 2030 and the return electrode 2032 when the RF ablation energy is applied by the repetitive method described above. (See Fig. 17) formed in the elliptical ablation section 2064 formed in the upper portion of the elliptical ablation section.

23-25 illustrate an alternative embodiment of a multiple electrode probe 2042 disposed at multiple orientations relative to the target nerve. For example, in FIG. 23, a multiple electrode probe 2042 is disposed across the nerve 2066, in FIG. 24 the multiple electrode probe 2042 is disposed parallel to a portion of the nerve 2066, And a plurality of electrode probes 2042 disposed across the target nerve 2066. As described in more detail above, each electrode 2046-2065 is preferably selectively connected to the excitation current source, the ablation energy source, ground, or left unconnected. Electrodes 2046-2062 are manually switched or switched and electrically activated.

The multiple electrodes of Figures 23-25 embodiment of the multiple electrode probes 2042 provide some enhanced placement and resection surgery. For example, FIG. 23 illustrates a method for selectively applying and positioning energy to a target nerve 2066, which proceeds substantially across the probe at one point along the axial length of the probe 2042. This placement method is characterized in that the practitioner initially positions the probe across the target nerve 2066. Electrodes 2046-2062 are then successively activated by the stimulating currents individually (monopolar mode) according to the adjacent active / ground pairs (bipolar mode) or external ground 2064. The practitioner can then observe the response of one or more muscles associated with the tympanic nerve as the stimulation current is applied to the continuous electrodes 2046-2062.

For example, referring to FIG. 23, a stimulation current may be applied between electrodes 2046 and 2048. The operator notes that there is no corresponding muscle response. A stimulation current may then be applied between the electrodes 2048 and 2050. Again, no muscle response is observed by the practitioner. Subsequently, a stimulating current is then applied to the successive electrode pairs. When a stimulation current is applied between the electrodes 2054 and 2056, there may be a flexible muscle response. When a stimulation current is applied between the electrodes 2056 and 2058, however, a strong muscle response will be observed. Subsequently, a stimulus is then applied between the electrodes 2058 and 2060. Where a greatly reduced muscle response is observed indicating that the nerve crosses the electrodes 2056 and 2058. Continuously, ablation energy may be applied between the electrodes 2056 and 2058 designated to ablate the nerve 2066.

24 illustrates a similar nerve location and resection operation in which the nerve 2066 is adjacent and substantially parallel to the axial length of the probe 2042 adjacent to the electrodes 2048-2066. In this second example, the practitioner first applies a stimulus current between the electrodes 2046 and 2048. Flexible or no muscle response can be observed. If a stimulation current is applied between electrodes 2048 and 2050, a strong muscle response is noted by the practitioner.

Continuously, a stimulation current is then applied between electrodes 2050 and 2052 and a similar strong muscle response is observed. This continuous stimulation and response process is observed through activation between electrodes 2056 and 2058 where the muscle response may be substantially reduced or not observed. This indicates that the electrodes 2048 to 2056 are all in contact with the nerve 2042. Electrodes 2048 through 2056 may then be switched to a cut-off current source and switched individually in bipolar or monopolar mode to consecutively or simultaneously, or to exclude nerve 2042, in a bipolar pair. The nerve can be ablated along the selected length defined by the many electrodes operated by the operator. The method may also be implemented as a monopolar mode and the stimulation or ablation energy is applied to the outside of the body between one or more electrodes 2046-2062 and a separate return electrode.

25 illustrates a substantially similar nerve placement and resection procedure in which the probes 2042 of multiple electrodes cross the nerve 2066 diagonally or at an oblique angle to the probe axis. 25 thus illustrates a method of angularly positioning the probe 2042 relative to the nerve 2066. As shown in Fig. In this example, applied stimulation currents as described above at electrodes 2052 and 2054 and 2056 will cause the response of the associated muscles. It is an indication that a larger nerve / probe contact area results from a more parallel contact arrangement of the probes 2042 relative to the nerve 2066 if a greater number of electrodes result in a response of the muscles. The determination of such angular placement can be improved by fabricating a probe with a relatively shorter distance between adjacent electrodes, relative to the diameter of the main nerve. The practitioner can also operate the probe to obtain a muscle response from some of the electrodes as desired, thus providing an opportunity to resect some of the length of the nerve without repositioning the probe axially.

The angular probe placement and subsequent stimulation methods can be combined with the repetition techniques as described above. For example, the stimulation current generator may initially be set at a relatively high level and may be reduced if the general location of the nerve for a given electrode is determined.

For example, the critical excitation current (to induce an observable response) between electrodes 2048 and 2050 in FIG. 25 will be higher than the threshold current between electrodes 2050 and 2053. This information may be displayed graphically, numerically, or acoustically to allow the practitioner to place the probes 2042 more parallel or more transversely to the nerve 2606.

The apparatus and methods described above may be implemented with various features that enhance the effectiveness and ease of use of the system, safety. For example, the probe may be implemented by an ergonomic and functional handle provided to enhance the effectiveness of operation and to implement safety characteristics. Individual probes can be carefully managed and preferably managed with system software, so that the selected probe will function properly, will not be effective and will not be reused, and the appropriate probe will be used for each particular treatment operation. Similarly, safety devices by the system may be included to ensure that the operator is authenticated and trained for a particular treatment protocol of choice. Various treatment modalities and special therapies may be selected for best results and improved patient safety. In one embodiment, treatment, treatment, and safety methods can be actively controlled and executed by software running on the associated processor, such as ablation devices and systems, as described in detail below.

How to manage your system

Effective system management methods can improve patient safety, surgical efficiency, and the simultaneous goal of success. System management methods as described herein may be implemented through computer software and hardware, including computer processors and memory, coupled to or in conjunction with the probe system and control console described herein. There may be various interfaces between the practitioner, the control console, and the probe system. In addition, hardware coupled with ablation systems, including probe stimulus current sources, ablation current sources, and probe systems, can communicate with or provide feedback to the system processor. Alternatively, steps of the system management method could be performed manually.

In software and processor-based system embodiments, the techniques described below for managing electrosurgical probes and systems may be implemented in a manufacturing article or device using standard programming and / or engineering techniques to produce software, firmware, hardware, , Or as a method. As used herein, the term " article of manufacture "is intended to encompass all types of media or devices (e.g., hard disk drives, floppy disks, magnetic storage media such as tape), optical storage Refers to logic or code stored in or executed in a volatile and nonvolatile device (e.g., EEPROMs, ROMs, PROMs, RAMs, DRAMs, SRAMs, firmware, programmable logic, The code in which the executions are made may additionally be accessible from a file server via a network or from a file server via a network. In such a case, the article of manufacture for which the code is executed may be a network transmission line, a wireless transmission medium, And may include transmission media such as radio waves, wireless, infrared, optical signals, etc. Of course, The skilled artisan can make many modifications to this structure without departing from the scope of the practice, and the article of manufacture may comprise certain information relating to media known in the art.

Therapeutic Treatment Protocols < RTI ID = 0.0 >

As described herein, tissue ablation or neural blocks or other minimally invasive electrosurgical procedures can be performed by accurately applied RF energy. A fundamental requirement of therapeutic RF waveforms is to heat and denature human tissue in small areas over a selected time frame, e.g., less than 25 seconds. According to laboratory tests, adequate time is indicated to adequately ablate small autonomic nerves. Longer or shorter treatment times may be required for other applications. The temperature required to denature the microstructure of the selected tissue, primarily protein and lipid, is about 65 ° C or higher. To securely achieve adequate ablation, neural blocks or other therapeutic objectives, an RF waveform can be generated and applied to meet the following criteria: 1. The probe temperature is adjusted to 160 Lt; 0 > C. 2. The probe temperatures will preferably be maintained between 90 [deg.] C and 105 [deg.] C. This range will prevent the adherence of excessive tissue and support the growth of appropriate resection lesions.

Initial RF power application will heat the temperature of the probe tip to a therapeutic temperature that operates in a controlled manner, thereby minimizing excess capacity. The time frame of the initial heating face may be 0.2 to 2.5 seconds.

In order to achieve the above general purpose, a special treatment protocol may be developed. In one embodiment of the invention, the supply of a special treatment protocol herein (such as also described as " an energy bolus ") is automated. Automation can allow the practitioner to focus on probe placement, It is possible to increase the safety and therapeutic efficacy.

For example, the system controller 401 may be configured to control the energy waveform supplied to the electrosurgical probe connected to the system. In particular, the waveform, waveform modulation or pulsation time can be controlled. In addition, the total time that the power source can be applied and the maximum power or voltage limit can be set can be controlled.

Moreover, a particular treatment protocol can be actively controlled according to feedback, such as probe temperature, adjacent tissue temperature, tissue impedance, or other physical parameters that can be measured during the supply of therapeutic energy. Special energy supply prescriptions or energy boluses may be developed for specific therapeutic purposes. These energy prescriptions can be stored in memory in combination with the controller as an approved therapy protocol. A representative therapeutic energy protocol 3250 is shown in tabular form in FIG.

The treatment protocol 3250 of FIG. 27 is optimized for therapeutic excision of human nerves having a diameter of approximately 1 mm. As shown in FIG. 27, treatment protocol 3250 is generally designed to rapidly heat tissue during initial phase 3252. Rapid heating during the initial phase is shown as minimizing perceived pain and reducing muscle irritation from the application of subsequent pulsed RF energy. The second phase 3254 includes a constant power supply reaching the desired therapeutic tissue / probe temperature more slowly. Also as shown in FIG. 27, the third phase 3256 includes growing the lesion to a desired size and maintaining a constant temperature at the reduced power source.

26 and 27 The exemplary therapy therapy treatment protocol 3250 is only one treatment protocol found to be suitable for resection of small autonomic nerves. Other treatment protocols may be developed for different or same therapeutic purposes. In all cases, the level of tissue ablation is exponentially related to the time and temperature of the temperature above 40 ° C, as is well known in the art as the Arrhenius rate. Thermal heat transfer through the target tissue can be calculated by a finite difference algorithm.

The tissue characteristics can be embodied in a 2D mesh, and such a characteristic is a random function of spatial agglomeration time. The Arrhenius velocity equation can be solved for the ablation zone caused by the increased temperature.

In addition, the optical and electrical properties of the ablated tissue can be measured and determined through histological studies. As such, various treatment protocols as illustrated in Figures 26 and 27 may be developed and optimized for controlled achievement of a given treatment outcome. Preferably, the treatment protocol is automatically supplied so that the selected energy mass is precisely supplied.

The devices and systems described below are provided as detailed examples of the structure and arrangement of components. The present invention includes modifications of methods, systems, and devices that are capable of other embodiments and that are implemented and performed in various ways. Also, the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The terms "including", "having", "containing", "involving", and uses of the variations herein, And equivalents thereof, as well as additional elements.

100: Device 102:

Claims (84)

10. A system for treating a nerve in a tissue region comprising a device and a controller, the controller being coupled to the device having a stimulation mode and an energy delivery mode and having a working end,
The stimulation mode includes at least a first parameter setting to stimulate the nerve at a first distance from the working end and a second parameter setting to stimulate the nerve at a second distance from the working end, the first distance being greater than the second distance, Wherein the device is configured to prevent activation of the energy supply mode when the stimulation mode is in the first parameter setting;
When the working end of the device is located in the tissue region and activated in the stimulation mode, the controller provides energy in a first parameter setting so as to stimulate the nerve;
The working end of the device is relocated to the tissue area to move the working end more closely to the nerve and reactivated to the stimulation mode at the second parameter, the controller supplies energy to be able to stimulate the nerve, Confirming that the working end is disposed closer to the nerve than to the nerve; And
When the device is activated in the energy supply mode, the controller provides energy to generate a first treatment period in the neural network in a predetermined treatment setting, and by activating the device in the energy supply mode, the controller resets the first parameter setting A neurotherapeutic system. The system of claim 1, comprising at least one injection port at an operative end of the device. The system of claim 1, further comprising an external nerve stimulator configured to form a nerve structure in the skin prior to inserting the device for use as a guide to identify a target treatment position. The system of claim 1, wherein the first parameter setting comprises a first current setting and the second parameter setting comprises a second current setting, wherein the second current setting is less than the first current setting. The system of claim 1, wherein the first parameter setting is fixed. The system according to claim 5, wherein the second parameter setting is adjustable. The method of claim 1, further comprising a measurement electrode, wherein activating the device in the stimulation mode at the first parameter setting to observe the nerve stimulation comprises measuring the electrical impulse in at least one muscle associated with the nerve using the measurement electrode ≪ / RTI > The system of claim 1, wherein the predetermined treatment setting comprises a predetermined temperature. The system of claim 1, wherein the device or controller comprises a manual override to apply an energy supply mode when the stimulation mode is in a first parameter setting. CLAIMS What is claimed is: 1. A neurological treatment system for muscles associated with neurons, said system comprising:
A single longitudinal probe configured to be inserted into the tissue region and coupled to the controller;
Wherein the threshold stimulation current setting on the controller is such that the probe is prevented from applying therapeutic energy at or above the threshold stimulation current setting;
The controller comprising a stimulation current setting that allows energy to be supplied through the probe to activate motion of the muscles associated with the nerve;
Wherein the controller is further configured to reduce the stimulation current setting below a threshold stimulation current setting such that the stimulation region of the probe decreases;
Confirming that the nerve position is within the reduced stimulation region of the probe by the nerve stimulation by the probe when the stimulation current setting is below the threshold stimulation current setting;
The therapy setting is configured such that when the stimulation current setting is below the threshold current setting of the controller to allow the probe to apply current to heat the nerve,
After the probe is energized with current to the therapy setting, the controller is configured to reset the stimulation current setting over the critical stimulation current. 11. The system of claim 10, further comprising an injection supply coupled to the injection port on the working end of the probe and the handling end of the probe. 11. The system of claim 10, further comprising an external nerve stimulator configured to replicate the nerve structure to the tissue region prior to inserting the probe into the tissue region. 11. The system of claim 10, wherein the threshold stimulation current setting is fixed. 1. A neurothermal system in a tissue region, the system comprising:
A probe having an operative end for positioning within the tissue;
And configured to provide power to the probe in a treatment mode and a stimulation mode and configured to be adjustable between a plurality of stimulation settings including at least a first stimulation setting and a second stimulation setting, A controller configured to inhibit powering in a mode;
The effective stimulation area of the probe at the second stimulation setting is smaller than the effective stimulation area of the probe of the first stimulation setting such that the working end of the probe is closer to the nerve at the second stimulation setting than at the first stimulation setting ; And
Wherein the controller is further configured to be reset to a first stimulus setting after power is applied in a treatment mode. 15. The system of claim 14, further comprising an anesthetic supply fluidly coupled to an aperture on the working end of the probe. 15. The system of claim 14 wherein the first stimulus setting is fixed. 17. The system of claim 16, wherein the second stimulus setting is adjustable. 15. The probe of claim 14, wherein the probe comprises an energy transfer section on the working end, comprising at least a first longitudinally spaced conductive portion and a second conductive portion on the probe separated by an electrical insulating material system. 15. The system of claim 14, further comprising a fluid port located above the working end between the first conducting portion and the second conducting portion. 15. The system of claim 14 wherein the surface area of the first conducting portion and the surface of the second conducting portion are different. 15. The system of claim 14, comprising at least one additional conducting portion spaced from the first conducting portion or the second conducting portion. 15. The system of claim 14, further comprising a temperature sensing element positioned between the first conducting portion and the second conducting portion. 15. The system of claim 14, wherein the insulator comprises a tapered profile. 15. The system of claim 14, further comprising an illumination source on the working end. 27. The system of claim 24, wherein the illumination source comprises a modulated flash rate proportional to the stimulus energy. 15. The system of claim 14, further comprising a lumen arranged to operate along a single axis probe length. 27. The system of claim 26, wherein the lumen communicates with a fluid reservoir. 15. The system of claim 14, wherein the controller is further configured to determine an impedance of tissue around the probe. 15. The system of claim 14, wherein the probe further comprises a handle configured to have a switch for adjusting the controller between a treatment mode and a stimulation mode. 32. The system of claim 29, wherein the switch is positioned for use with one hand. 15. The system of claim 14, further comprising an indicator source on the handle. 32. The system of claim 31, wherein the indicator source provides a first time indicator for the stimulation mode and a second time indicator for the treatment mode. 15. The system of claim 14, wherein the first stimulus setting comprises 0.07 milliamps. An electrosurgical device for use with a reservoir having flowable material and for use with a stimulation energy source and a therapeutic energy source for stimulating and treating tissue under the skin, the device comprising:
Device body;
A rigid probe extending from a portion of the device body and allowing the probe to move within the tissue by manipulation of the device body;
A distal electrode positioned at an operative end of the probe;
And applying a therapeutic energy to the distal electrode and the proximal electrode to cause damage to the tissue region across the proximal and distal electrodes, wherein the distal and proximal electrodes are proximate to the distal electrode A proximate electrode positioned over a single probe spaced apart;
And a fluid supply sleeve positioned between the distal electrode and the proximal electrode and having at least one fluid port for directing the at least one fluid port to supply the fluid material in a direction perpendicular to the probe axis such that the fluid material is directed to the tissue region Lt; / RTI > 35. The device of claim 34, comprising a fluid supply lumen for supplying a flowable material in an axial direction flowing from the distal end of the probe into the tissue. 35. The device of claim 34, comprising an anesthetic supply fluid fluidly coupled to an aperture in the operative end of the probe. 35. The device of claim 34, wherein the surface area of the distal electrode and the surface area of the proximal electrode are different. 35. The device of claim 34, comprising at least one additional electrode spaced from the proximal or distal electrode. 35. The device of claim 34, further comprising a temperature sensing element located between the distal electrode and the proximal electrode. 35. The device of claim 34, further comprising an illumination source at the working end. 41. The device of claim 40, wherein the illumination source comprises a modulation flash rate proportional to the amount of stimulus energy supplied. 35. The device of claim 34, wherein the probe further comprises a handle having at least one switch configured to switch the controller between a treatment mode and a stimulation mode. 43. The device of claim 42, wherein the switch is adapted to be used with one hand. 35. The device of claim 34, further comprising an indicator source on the handle. 45. The device of claim 44, wherein the indicator source provides a first visual indicator for the stimulation mode and a second visual indicator for the treatment mode. 35. The device of claim 34, wherein the first stimulus setting comprises 0.07 milliamperes. CLAIMS What is claimed is: 1. A neurothermal treatment of a tissue area comprising:
Disposing the device at the first location into the tissue region;
Applying energy to the tissue through the device at a first location using a first configuration configured to stimulate the nerve within a first distance from the operative end of the device;
Observe to stimulate nerves;
Re-applying energy from the operative end of the device through the device to the tissue region at a second location using a second configuration configured to stimulate the nerve within a second distance less than the first distance;
Re-measuring whether the nerve is stimulated in a second setting to determine whether the second position is closer to the nerve than the first position;
When the second position is closer to the nerve, the second setting is used to observe the nerve impulse, the device is used to deliver the nerve signal to the nerve so as to affect the nerve function and to apply the therapeutic energy to the nerve Lt; RTI ID = 0.0 > neuronal < / RTI > 51. The device of claim 47, wherein the device is reset to a first setting after application of energy to the nerve, the method comprising: resetting the device to a second setting and configuring a device configured to stimulate the nerve within a second distance from the working end of the device 2 < / RTI > configuration to subsequently re-energize the tissue region through the device at a subsequent location. 50. The method of claim 47, wherein re-applying energy to the tissue region through the device at the second location comprises moving the device in a predetermined direction relative to the nerve to create multiple treatment areas along the nerve. 50. The method of claim 49, wherein moving the device in a predetermined direction relative to the nerve comprises moving the device in a forward direction away from the first position along the nerve to stimulate a muscle coupled with the nerve during nerve stimulation. 55. The method of claim 49 wherein disposing the device in a first position and a second position is accomplished without detaching the device from the injection site. 50. The method of claim 47, comprising moving the device in a plurality of directions without separating the device from the tissue region prior to reapplying energy at the second location. 49. The method of claim 47, further comprising injecting an anesthetic in or near the tissue region at a first location prior to applying energy to the tissue region. 51. The method of claim 47, comprising applying energy to the nerve and lowering the surface temperature of the tissue region above the treatment site prior to maintaining the ice in place during energy delivery. 47. The method of claim 47, further comprising using an external nerve stimulator to replicate the nerve structure to the skin prior to inserting the probe and using the map as a guide to identify target treatment locations. 47. The method of claim 47, wherein the first setting comprises a first current setting and the second setting comprises a second current setting, wherein the second current setting is less than the first current setting. 49. The method of claim 47, wherein the first setting is fixed. 29. The method of claim 28, wherein the second setting is adjustable. 49. The method of claim 47, wherein the observation for nerve stimulation comprises an observation for movement of a tissue area surface. 47. The method of claim 47, wherein the observation for nerve stimulation comprises conducting an electromyography test on at least one muscle associated with the nerve. 51. The method of claim 47, wherein the observation for nerve stimulation comprises measuring an electrical impulse in at least one tissue associated with the nerve using a measuring electrode. CLAIMS What is claimed is: 1. A neurothermal treatment of a tissue area comprising:
Placing the working end of the device into the tissue region;
Stimulate the nerves;
Rearranging the working end of the device in the tissue region to move the working end closer to the nerve;
Reactivating the device in the stimulation mode in a second parameter to observe the nerve impulse and to confirm relocation of the working end of the device closer to the nerve;
Activating the device in an energy supply mode to create a first treatment area on the nerve at a first treatment location on the nerve;
Rearranging the working end of the device at the nerve end between the nerve-controlled muscle and the first treatment location; And
And activating the device in an energy supply mode to create a second treatment area in the nerve at a second treatment location above the nerve. 61. The device of claim 62, wherein the device comprises: a stimulation mode comprising at least a first parameter setting to stimulate the nerve at a first distance from the working end, a second parameter setting to stimulate the nerve at a second distance from the working end, Wherein the first distance is greater than the second distance and the device is configured to prevent activation of the energy supply mode when the stimulation mode is in the first parameter setting. The method of claim 63, wherein activating the device in an energy supply mode resets the device with a first parameter setting. 63. The method of claim 62, wherein placing the operative end of the device and relocating the operative end of the device is performed without detaching from the injection site. 63. The method of claim 62, further comprising injecting an anesthetic in or near a first treatment zone prior to activating the device in an energy supply mode. 63. The method of claim 62, further comprising using an external nerve stimulator to replicate nerve tissue to the skin prior to inserting the device and using the map as a guide to identify target treatment locations. The method of claim 62, wherein the predetermined treatment setting comprises a predetermined temperature. 63. The method of claim 62, wherein the device comprises a controller configured to drive the device between a stimulation mode and an energy supply mode. 63. The method of claim 62, wherein the device is capable of manually resuming application of an energy supply mode when the stimulation mode is in a first parameter setting. CLAIMS What is claimed is: 1. A neurothermal treatment of a tissue area comprising:
The device placing the working end of the device in a tissue region at a first location configured to apply stimulation energy and therapeutic energy;
The device may be set to one of a plurality of settings that include at least a first setting and a second setting and the stimulation area of the device is wider when the device is operated in the first setting, The device is configured to prevent application of therapeutic energy when present;
Operating the device in a second setting;
Observe the response in the tissue area for nerve stimulation;
Upon observing the response, the therapeutic energy is applied to at least a portion of the nerve at the first location to prevent the nerve from transmitting a signal by applying therapeutic energy to the tissue area, and after applying the therapeutic energy, Reset to the settings;
Monitoring at least a portion of the nerve for a predetermined treatment setting;
Rearranging the working end of the device at a subsequent location away from the first location;
Adjusting the device from the first setting to the second setting;
Observe subsequent responses in the tissue region for nerve stimulation; And
And applying therapeutic energy in at least a second portion of the nerve at a subsequent location by applying therapeutic energy when observing a subsequent response. 69. The method of claim 71, further comprising relocating the working end of the device in a predetermined direction relative to the nerve to create a plurality of treatment areas along the nerve. 75. The method of claim 72, wherein moving the working end of the device in a predetermined direction relative to the nerve comprises moving the working end of the device in a forward direction away from the first position along the nerve to stimulate the nerve associated muscles during nerve stimulation Methods of inclusion. 69. The method of claim 71, wherein relocating the working end of the device at a subsequent location is performed without detaching the working end of the device from the tissue region. 69. The method of claim 71, wherein relocating the working end of the device includes moving the device in a plurality of directions without detaching the working end of the device from the tissue region. 69. The method of claim 71, comprising injecting an anesthetic in or near the tissue region at a first location site prior to applying energy to the tissue site. 75. The method of claim 71 comprising applying a therapeutic energy and reducing the surface temperature of the tissue zone on the treatment zone prior to maintaining the ice in place during energy delivery. 69. The method of claim 71, further comprising using an external nerve stimulator to simulate nerve tissue in a tissue region prior to using the map to insert an active end of the device into the tissue region and identify target treatment locations. 75. The method of claim 71, wherein the first setting comprises a first current setting and the second setting comprises a second current setting, wherein the second current setting is less than the first current setting. 75. The method of claim 71, wherein the first setting is fixed. The method of claim 80, wherein the second setting is adjustable. 72. The method of claim 71, wherein observing the response of the tissue region for nerve stimulation comprises observing movement of the tissue region surface. 69. The method of claim 71, wherein observing the response of the tissue region for nerve stimulation comprises performing electromyography on at least one muscle associated with the nerve. 69. The method of claim 71, wherein observing the response of the tissue region for nerve stimulation comprises measuring an electrical impulse in at least one muscle associated with the nerve using a measurement electrode.

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