AU2016209266B2 - Systems and devices to identify and limit nerve conduction - Google Patents

Abstract

Methods and devices for improved precision in finding one or more nerves and then interrupting the transmission of neural signals through the target nerve. The treated nerve can be rendered incapable of transmitting neural signals for a select duration of time, where such a duration can be on a temporarily basis (e.g., hours, days or weeks) or a longer term/permanent basis (e.g., months or years). One embodiment of the apparatus includes a precise energy source system which features energy transfer elements that are capable of creating areas of nerve destruction, inhibition and ablation with precision.

Description

SYSTEMS AND DEVICES TO IDENTIFY AND LIMIT NERVE CONDUCTION CROSS-REFERENCETLO RELATED APPLCATIONS

[00011 Thisapplication aimrns piont to each of U.S. Patent Appli.Ciuon No 14/602,180; 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. 14602,196 (now U.S Patent No. 9,119,628 issued Septenber 1, 2015) each of which applications were filed on.January 21, 2015 and each of which is incorporated by reference herein.

BACKGROUND OF THE INVENTION 10002] The present invention relates to methods and devices for improved precision in finding one or more nerves and then interrupting the transmission ofneural signals through the target nerve. The treated nerve can be rendered incapable oftransmittingneuralsignals fora select duration of time, where such a duration can be on a temporarily basis (eg, hours, days or weeks) or a longer term/permanent basis (e.g. months or years), One embodiment of the apparatusincludes a precise energy source system which features energy transfer elements that are capable of creating areas of nerve destruction, inhibition and ablation with precision.

10003] The human nervous system sends and receives signals to convey both sensory information, such as pain, heat, coldand touch, as well as command signals that control muscleinmvement. There are many cases where disrupting the neural signal can provide preventative, therapeutic, and/or cosmetic benefits to an individual. For example, extraneous, undesired, or abnormal signals can be generated (or are transmitted) along nervous system pathways. For example, the pinching of a minornerve in the back can cause extreme back pain Similarly, the compression. or other activation of certain nerves can induce significant or constant pain. Certain diseases also may compromise the lining of nerves such that neural signals spontaneously generate. This spontaneous generation can cause a variety of maladies, from seizures to pain or (inextreme conditions) even death. Abnormal signal. activations 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 physically detrimental afflictions.

00041 In some situations, the normal conduction of neural signals causes undesirable 4muscle causesfrown lines that can resultin permanent distortion of the brow (or forehead); giving the appearance of premature aging. Interrupting the neural signal ofthe corrugator supercilli activation nerves can alleviate the distortion ofthe brow or forehead.

[00051 Traditional electrosurgical procedures use either a unipolar or bipolar device connected to an energy source. A unipolar electrode system includes a small surface area electrode, and return electrode placed in contact with the body at a location separate and spaced from the small surfacearea electrode. The return electrode is generally larger in size, and is either resistively or capacitively coupled to the body. Since the same amount of current must flow through each electrode to complete the circuitBecause the return electrode is typically a large surface area the decreased current density allows heat tobe dissipated over the larger surfacearea. in some cases, it is desirable to locate return electrodes inareas of high blood flow (such as the biceps, buttocks or other muscular or highly vascularized area) so thatany generated heat generated is rapidly carried dissipated. One advantage of a unipolar system is the ability to place theunipolar probe exactly where it is needed and optimally focus electrosurgicaleneywhere desired, A resistive return electrode would typically be coated with a conductive paste or jelly. If the contact with the patient is reduced or if thejelly driesout,ahigh-currentdensityarea may result., increasing the probability for burns at the contact point.

[00061 Typical bipolar electrode systems are generally based upon a device having electrodes of opposite polarity. Each electrode is connected to one of the two poles of the electrosurgical generator. When the electrosurgicalenergyis applied, it is concentrated (and focused) so that current flows between the electrodes of opposite polarity in the region of the device. Assuming the instrument has been designed and used properly, the resulting current flow\ will be constrained within the target tissue between the two surfaces.

[00071 Treatments for the elimination of glabellarfurrowing have included surgical forehead lifts, resection of corrugator supercilli muscle, as described by Guyuron, Michelow and Thomas in Corrunator Supercilli Muscle Resection Through Blepharoplastyincision., Plastic Reconstructive Surgery 95 691-696 (1995). Also, surgical division of the corrugator superclli motor nerves is used and was described by Ellis and Bakala in Anatomv of the Motor Innervation of theCorrugator Supercilli Muscle: Clinical Significance and Development of a New Surgical Technique for Frowning., J Otolaiyngology 27:222-227 (1998).'These techniques described are highly invasive and sometimes temporary as nerves regenerate over tine and repeat or aterative procedures are retired.

[0008] Another less invasive procedure to treatlabellar furrowin involves iljction of botulinum toxin (Botox) directly into the muscle. This produces a flaccid paralysis and is best described in The New England Journal of Medicine, 324:1186-1194 (1991) While minimally invasive, this technique is predictably transient; so,it must be re-done every few months.

100091 Specific efforts to use RF energy viaa two needle bipolar system has been described by Hernandez-Zendejas and GuerreroSantosin:PercutaneousSelectiveRadio Frequency Neuroablation in Plastic Surgery, Aesthetic Plastic Surgery, 18:41 pp 41-48 (1994)The authors describeda bipolar system using two parallelneedle type electrodes. Utley and Goode described a similar systemin Radio-frequency Ablation of the Nerve to bhe Corrugator Mtiscle for Elimination of Glabellar Furrowing, Archives ofFacial Plastic Surgery January-March, 99, VI P 46(48, and U.S. Pat. No- 6,139,545. These systems were apparently unable to produce permanent results possibly because of limitations inherent in a two needle bipolar configuration, Thus, as is the case with Botox, the parallel needle electrode systems would typically require periodic repeat procedures.

[00101 There are many ways of properly locating inactive electrodenear the target tissueand determining if it is in closeproximity to the nerve such that the treatment is limited to the area of interest, In many applications, there is a need to ensure that the nerve is located and treated to establish desired effect whileminimizing collateral damage to surrounding tissues. Such is especially the case in cosmetic application.

100111 Various stimulaion devices havebeen made and patented One process of stimulation and ablation using a two-needle system is disclosed in U.S. Pat No, 6,139,545. The stimulation mayalso be implenented negatively, where tissue not responsive to stimulation is ablated as is described in .S, Pat- No. 5,782,826 (issued Jul, 21, 1998).

SUMMARY OF THE INVENTION 10012] The present invention relates to devices and methods for positioning a treatment device adjacent to anerve. stinmulating the nerve and thenapplying a therapeutic treatment to impair the nerve'sability to transmit a neural signal, In particular, the devicesand methods can be used ina cosmetic application in theareas of the headand face However, the devices and methods can be used in any part of the body.

100131 The present disclosure includes methods of treating a nerve inatissue region. One example of such a method comprises positioning a working end of a device into the tissue region; where the device includes a stimulation mode and a treatment mode, the stimulation mode comprises at least a first parameter setting that stimulates the nerve at a first distance from the working end, and asecond parameter setting thatstimulates the nerve at a second distance from the working end, where thefirst distance is greater than the second distance, and where 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 a stimulation of the nerve repositioning the working end of the device in the tissue region tomove the working end closer to the nerve; re-activating the device in the stimulation modeat the second parameter to observe stimulation of the nerve and confirm repositioning of the working end of the device closer to the nerve; andactivating the device in the treatmentmode to create a first treatment zone on the nerveat a pre-determined treatmentsetting, whereactivating the device in the treatment mode causes the device to reset to the first parameter setting,

100141 The method can further include moving the working end in a direction relative to the nerve to create multiple treatment zones along the nerve. In certain variations, moving the working end of the device in the direction relative to the nerve comprises moving the working end of the device ina fovard direction distally to a first treatment area along the nerve such thata muscle associated with the nerve can be stimulated during stimulation of the nerve.

[00151 Variations of the method include positioning the working end of the device and repositioning the working end of the device occurs without removing the device from the puncture site. Moving the device can include moving the device in a plurality of directions withoutremovingthe device from the tissue region to increase an areafor observing stimulation of the nerve.

[0061 The method can also further comprise injecting an anesthetic at or near the first treatment zone prior to activating the device in the treatment mode.

[00171 The methods and devices can also include reducing a temperature of thesurface of the skin above the treatment site prior to applying energy and keeping the ice in place during application of energy.

100181 In an additional variation.the methods can further comprise the use of an external nerve stimlator to map the nerve anatomy on the skin, prior to inserting the device, and using the map as a guide to identifytarget treatment locations.

[00191 In certain variations the first parameter setting comprises a first current setting and the second parameter setting comprises a second current setting, where the second current setting is less than thefirst current setting. Thefirst parameter setting can be fixed and/or the second parameter setting can be adjustable.

100201 The method. can also include activating the device in the stimulation mode at the first parameter setting to observe the stimulation of the nerve comprises observing movement of a surface of thetissue region. The method can also include activating the device in the stimulation mode at the first parameter setting to observe the stimulation of the nerve comprises performing electromyography on at least one muscle associated with the nerve..Additionally, activating the devicein the stimulation mode at the first parameter setting to observe the stimulation of the nerve comprises measuring an electricalimpulse in at least one muscle associated with the nerve usingameasuring electrode

0021] In another example, the present disclosure includes a method oftreating a nerve in a tissue region. In one variation themethod includes positioning a device intothe tissue regionata first location; applying energy to the tissue region through the device at the first location using afirst setting configured to stimulate the nerve within a first distance from the working end of the device; observing for stimulation of the nerve; re-applying energy to the tissue region through the device at asecond location using a second setting configured to stimulate the nerve within a second distancefrom the working end ofthe device,where the second distance is less than the first distance; re-assessing whether the nerve is estimated at the second setting to determine if the second location is closer to the nerve than the first location; applying energy to the nerveto affect the ability ofthenerve to transmit a neural signal using the device upon observing stimulation of the nerve using the second setting if the second location is closer to the nerve.

[00221 The method can include the device resetting to the first setting after applying energy tothenerve, themethod further comprising re-adjusting the device to the second setting and subsequently re-applying energy to the tissue region through the device at a subsequent location using a second setting configured to stimulate the nerve within the second distance front the working end of the device.

10023] The method canalso moving the device ina direction relative to the nerve to create muliple treatment zones along the nerve. Themoving of the device in the direction relative to the nerve can comprise moving the device in forward direction distally to the first location along the nerve such that a muscle associated with the nerve can be stimulated during stimulation of the nerve. In additional variations positioning the device at the first location and the second location occurs without removing the device from the puncture site,

10024] The method can further comprise moving the device in a plurality of directions without renoving the device from the tissue region prior to re-applyingenergyatthe second location. The method can also include injecting an anesthetic at or near the tissue region at the first location site prior to applyingenergy to the tissue region.

[00251 In another variation, a method can include positioninga working end of a device into the iIssue region al a first location where the device is configured to apply stimulation energy and to apply therapeutic energy; wherein when supplying stimulation energy the device is settable in one of apluralityofsettings,thepluralityofsettings comprising at least a first setting and a second setting, where a stimulation area of the device is larger when the device is operated at the first setting, and where the device is configured to prevent application of the therapeutic energy when the device is in the first setting; operating the device at the second setting; observing a response in the tissue region for stimulation of the nerve; applying therapeutic energyto at least a portion of the nerve to prevent the nervefrom transmitting a neural signal by applying the therapeutic energy to the tissue region upon observing the response, wherein afterapplying therapeutic energy the device resets to the first setting; repositioning the working end of the deviceat a subsequent location; adjusting the device to the second setting from the first setting; observing a subsequent response in the tissue region for stimulation of the nerve; and applying therapeutic energy at least a second portion of the nerve at the subsequent location by applying therapeutic energy upon observing the subsequent response.

.00261 The method can include moving the devicein a directionrelative to the nerve to create multiple treatment zones along the nerve.

[00271 In another variation, the method of treating a nerve can include inserting a single longitudinal probe into a tissue region, where the probe includes a threshold stimulation current setting where the probe is prevented from applying therapeutic energy ator abovethethresholdstimulationcurentsetting;directingtheprobetiptowardsthe nerve; delivering a stimulating current through the probe to trigger movement of a muscle associated with the nerve;reducing a stimulating current setting below the threshold stimulation current setting such that a stimlation area of the probe decreases; moving the probe in the tissue region towards the nerve; stimulating the nerve to trigger movemento.f the muscle and confirm that the location of the nerve is within the decreased stimulauon area of the probe; applyingan electrical current to heat the nerve upon observing the movement of the muscle, wherein after applying electrical current the stimulation current setting is reset above the threshold stimulation current,

[0028] The present disclosure also includes a system for treating a nervein a region of tissue, the system comprising: a probe having working end for positioning within tissue; a controller configured to provide power to the probe in a therapeutic mode and a stimulation mode; where the controller isfurther configured to be adjustable between a plurality of stimulation settings, the plurality of stimulation settings comprising atleasta first stimulation setting and a second stimulation settingand where the controller is further configured to prevent application of power in the therapeutic mode when unless set to the second stimulation setting; where an effective stimulation area of the probe is reduced in the second. stimulation setting as compared. to the effective stimulation area of the probe in the first stimulation setting such that the working end of the probe must be closer to the nerve in the second stimulation setting than in thefirst stimulation settingto stimulate the nerve; and where the controller is further configured to reset to the first stimulation setting after application of power in the therapeutic mode.

10029] The system can include an anesthetic supply fluidly coupled to an opening on the working end of theprobe, winsome variations, thefirst stimulation setting is fixed. Alternatively, or in combination the second stimulating setting can be adjustable.

[00301 The system can include an energy transfer section on the working end, where the energy transfer section comprises at least a first conductive portion and a second conductive portion longitudinally spaced on the probe, the first and the second conductive portionsseparated by an electrically insulative material.

[00311 Variations of the system can include fluid port located on the working endand between the first conductive portion and the second conductive portion.

100321 In some variations, a temperature sensing element is located between the first conductive portion and the second conductive portion.

[0033_ The system can also include an illumination source on the working end, The illumination source can comprisesa modulation flash rate proportional to the amount of stimulation energy.

.00341 The device can also include luen operatively disposedalong the length of thesingle axis probe.

[00351 The present disclosure also includes electrosuricaldevices for use with a source of stimulation energy andasourceoftherapeutic energy to simulateand treat tissue under skin and for use with a reservoir having a flowable substance. For example, the device can include a device body; a probe extending from a portionof the device body, the probe being rigid such that manipulation of the device body permits movement of the probe within tissue; a distal electrode located at a working end of the probe; a proximal electrode positioned on the probe and spaced proximally from the distal electrode, where the distal and proximal electrodes are coupleable to the source of stinlation energy and the source of therapeutic energy, where application of the therapeutic energy to the distal electrode and proximal electrode forms a lesion in a issue region spanning between the proximal and distal electrodes; a fluid dispensing sleeve having one or morefluid ports, the fluid dispensing sleeve positioned between the distal electrode and proximal electrode whereat least one of the fluid ports is oriented to deliver the flowable substance in an ohogonal direction to an axis of the probe such that theflowable substance is directed to the tissue

region.

100361 The device can also include afluid dispensing lumen that delivers the flowable substance in an axial direction out the tip of the probe into the tissue.

[0037] The present disclosurealso includes systemsfr carrying out or performing the treatment disclosed herein. Such systems can include a system for treating anerve in a tissue region comprising a device and a controller, the controller coupled to the device havinga working end where the controller includesa stimulation mode andan energy delivery mode, the stimulation mode comprises at least afirst parameter setting that stimulates the nerve at a first distance from the working end, and a second parameter setting that stimulates the nerve at a second distance from the working end, where the first distance is greater than the second distance, and where the deviceis configured to prevent

S activatton ofthe energy delivery mode when the stimulation mode isin the first parameter setting; where when the working endof the device is positioned in the tissue regionand activated in the stimulation mode the controller provides energy at the first parameter setting to allow stimulation of the nerve; and when the working endof the device is repositioned in the tissue rgion to move the working end closer to the nerve and re activated in the stimulation mode at the second parameter the controller delivers energy to allow stimulation of the nerve and. confirm repositioning of the working end of the device closer to the nerve; and when the device is activated in the energy delivery mode the controller provides energy to create a first treatment zone on the nerveat a pre-detenined treatment setting, whereactivating the device in the energy deliverymode causes the controller to reset to the first parameter setting.

[00381 Another variation ofa system includes a system for treating a nerve of anmscle associated with the nerve thpe system: comprising: comprising a sine longitudinal pmbe coupled. to a controller, where the single longitudinal probe is configured for insertion into a tissue region; a threshold stimulation currentsetting on the controller where the probe is prevented from applying therapeutic energy at or above the threshold stimulation current setting; the controllerfurther including a stimulating currentsetting,thatpermitsdelivery of energy through the probe to trigger movement ofthe muscle associated with the nerve: where the controller is further configured to reduce the stimulating current setting below the threshold stimulation current setting such thata stimulation area ofthe probe decreases; wherein stimulating,the nerve by the probe when the stimulating current setting is below the threshold stimulation current setting confirms the location of the nerve is within the decreased stimulation area of the probe;a treatment settingon the controller configured to be applied when the stimulation current setting is below the threshold cutrent setting on the controller, such that the treatment setting allows the probe to apply an electrical current to heat the nerve,wherein after the probe applies electrical current in the treatment setting the controller is conflgured to reset the stimulation current setting to above the threshold stimulation current.

10039] The systems described herein can include atleast one injection port at the working end of the device as wellas a fluid supply for any anesthetic or medicine,

100401 The systems can include an externalnervestimulator configured to map the nerve anatomy on theskin, prior to inserting the device, for use as a guide to identify target treatment locations.

10041] The systems can be configured such that the first parameter setting comprises a first current set-ngand the second parameter setting comprises a secondcurrentsetig where the second current setting is less than the first current setting. The first or second parameter settings can be fied or variable.

[00421 The systems can also include measuring electrode, where activating the device in the stimulation mode at the first parameter setting to observe the stinmlation of the nerve comprises measuring an electrical impulse in at least one muscle associated with the nerve using the measuring electrode.

100431 The systems can be configured such that the pre-determined treatment selling comprises a pre-determined temperature.

[0044_ Any of the systems can be configured such that the device orcontroller comprisesa manual override to allow application of the energy delivery mode when the stimulation mode is in the first parametersetting.

[00451 Theaboveand other features of the invention including various novel details of construction and combinations of parts, and other advantages, will now be more particularly described with reference to theaccompanying drawings and pointed out in the claims. It will be understood that the particular method and device embodying the invention are shown by way of illustration and not as a limitation of the invention. The principles and features of this invention may be employed in various and numerous embodiments without departing from the scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS 100461 The foregoing and other objects, features and advantages of the methods, devices, and. systems described herein will become apparent from thefollowingdescription in conlimctior with the accompanying drawings, in which reference characters refer to the same parts throughout the different views. The drawirngsare not necessarily to scale emphasis has instead been placed upon illustrating the principles of the invention.

[00471 FIG. I illustrates an example of a device configured for stimulation and treatment of nerves.

100481 FIG, 2 illustrates another variation ofa treatment device coupled toa reservoir delivery member as well as acontrolepowersupply.

10o

10049] FIG 3Aillustratesa variation of working end of a singleaxis probe having at least one energytransmitng region with sensors and/or fluid delivery ports positioned in the working end.

[00501 FIG-313 illustrates another variation of a working end of devices described herein,

.00511 FIG. 3C showsan example ofa device positioned in tissuew here theenergy transmitting regions and create a lesion within the tissue.

[00521 FIGS, 4A to 4G illustrate use of devices and systems described herein when used to perform a treatment in a patient

[00531 FIG, 5 illustrates another feature of the dual function device where the fluid ports located on the device deliver a substance between treatment portions of the device.

[0054] FIGS. 6A and 6B illustrate various additional examples of creating treatment sites to effect a therapeutic benefit.

[00551 FIG. 6C illustrates another example of lesions being created on theangular nerve in a manner as described herein.

[00561 FIG. 7 Bi-Polar Driver System.

10057] FIG, 8A Schematic diagram of the hi-polar needle.

10581 FIG, 8B Schematic diagram of the split bi-polarneedle.,

10059] FIG, 9A Magnified side view of conical bipolar probe.

100601 FIG. 9B Magnified side view ofhollow chisel bi-polar probe.

100611 FIG, 9C Magnified side view of tapered conical bi-polar probe,

[00621 FIG. 9D Magnified side view of split conical bi-polar probe.

[00631 FIG. 10 Schematic diagram of the bi-polar driver ssten.

[00641 FIG. IIA Ablation Procedure without Auxiliary probe.

[00651 FIG. IIB Ablation Procedure with Auxiliary probe,

[00661 FIG. 12A. Side view Hybrid bi-polar needle fornerve ablation,

100671 FIG. 12B Side view Hybrid bi-polar needle for tumor ablation.

[00681 FIG. 13A Side view of auxiliary nerve probe.

II

100691 FI& 13B Side view of auxiliary dual-tipped nerve probe.

100701 FIG 14 Side view of guided ablation procedure with auxiliary nerve probe(s).

[0071] FIG 15 Sample electro-surgery waveforms.

100721 FIGS. 16A-16B Controller and probe data base structure.

[00731 FIG, 17 Side view of visually guided ablation procedure.

[00741 FIG. 18 is a side view of a singleaxis electrosurgical probe having equal surface area electrodes.

100751 FIG. 9 is a side view of a singleaxis electrosurgical probe having two electrodes of differing surface areas.

100761 FIG. 20 is a side view of a sinLeaxiselectrosurgical probe having two electrodes of differing surface areas.

100771 FIG. 21 is a side view of asingle axis electrosurgical probe having hree electrodes.

[00781 FIG 22 is a side view of a single axis electrosurgical probe having three electrodes anda curved handle portion.

[00791 FIG 23 is a side view of a single axis electrosurgical probe havingmuliple electrodes transverse a nerve.

100801 FIG 24 is a side view of a single axis electrosurgical probe having multiple electrodes parallel to a nerve.

100811 FIG. 25 is a side view of a single axiseletrosurgical probe having multiple electrodes crossing nerveatanangle.

[00821 FIG- 26 isa tabular representation of a therapeutic energy protocol consistent with the present invention.

[00831 FIG. 27 is a graphic representation of a therapeutic energy protocol consistent with the presentinvention.

DETAILED DESCRIPTION OF THE INVENTION 100841 The following illustrationsare examples ofthemethods and devices included in the invention described hereinIt is contemplated that combinations of aspects of specific embodiments or combinations of the specific embodiments themselves are within the scope of this disclosureWhile the methods, devices, and systems described herein are discussed as being used in to treatnerves especially for cosmetic purposes, the devices, methods, and systems of the present disclosure can be can be used in other parts of the body where accurate ablation or application ofenergy is desired.

[00851 The present disclosure is related to commonly assigned Application Nos. (0/870,202, filed June 17, 2004, publication No., S-2005-0283148~A1; 1/460870, filed July 28 2006, publicationNo. US~2007-0060921-A; 14/594,935, filed January 12, 2015; 11/559,232, filed November 13, 2006, publication No. US2007-0167943-A 1 12/612,360, filed November 04, 2009, publication No,US-20 10-0I14095-Al; 13/570,138, filed August 08, 2012, publication No. USn2013-0046292-Al; 12/605;295, filed October 23, 2009, publication No. US-2010-0114191~A1. now US Patent No. 8666498;4/156,033filed January 15.2014, publication No. US-2014-0180360-A1. now US Patent No. 8938302; and 14/599,161,filed January 16, 2015, the entirety of each of which is incorporated by reference..

100861 FIG1, illustrates one example of a device 100 configured to locateand treata nerve. As described below, the device 100 is part of a system that can identify a nerve and also deliver energy to interfere with the nerve's ability to transmit signals. In many cases the energy will have a thermal effect on the nerve. However, any treatment modality can be used to disrupt the ability of the nerve to transmit a neural signal. As illustrated, a variation of the device 100 includes a device body 102 that can optionally be ergonomically designed so that a physician can grip the device 100 and position the device 100 and/or working end 104 accordingly using fine motor skills. Typically, such placement can be achieved by balancing the device body 102 in a hand 2 or a web of the hand 2 between a forefinger 4 and thumb 6, however, the devices and methods described herein can includeany number of configurations that allow for positioning. In addition, variations of the device allow forpositioning using automated machinery such as robotic manipulators and/or positioners, Variations of the device 100 can includefeatures to permit left or right handed operation. Alternatively, the device body 102 can be symmetrica~lallowingfor left or right handed operation.

[00871 FIG. I also illustrates a switch 112 that is located on the device body 102 and pennits the physician to easily and safely initiate the delivery of energyin either a stimulation mode or a therapeutic mode. Again, variations of the device can include a switch that is external from the device body 102 e.g., a foot pedal, audible command, or other triggering means However, the illustratedvariation depicts a rocker switch 112 where rear andforward 114,116 rocking or triggeringmovement of the switch 112 either increases or decreases the strength ofthe stimulation signal. Accordingly, the system shown in FIG I as well as the systems described herein include a dual purpose system that can operate in a nerve stimulation mode and an ablation/treatment mode.

[00881 As described below, the physician canadjust a degree of stimulation (i.e., the range from the device at which nerves are stimulated) as well as trigger stimulation, without moving the device 100 or hand 2 from the device, The device body 102 can generally include three operational switches (or a single switch with three positions. In the illustratedfigure lateral operations/positions 114 116 ofswitch 112 either increases or decreases a stimulation current (or range) of the device. The centeroperation/position 118 initiates the stimulation mode. Once a physician locates an acceptable treatment site, the physician can initiate a therapeutic energy delivery mode by depressing a switch (e.g.,152 or 154) of the switch. In many cases the physician can initiate the therapeutic mode by depressing a foot pedal 152. Such a feature minimizes unintentional triggering of the therapeutic mode. However, variations of the device include the use of an optional switch 154 located on the device 100. In additional variations, the therapeutic mode can be triggered from the controller"150and/or from continued operation of switch 112,

[00891 Additional variations of the device can include triggeringoftheenergydelivey mode with either end of the switchandactivation of the stimulation modevia the center of the switch or separate pedal as shownAlternatively, or in combination, a separate switch (e.g,. ,154) can be positioned anywhere on the device body 102. FIG. I illustrates a sealed rocker switch 112 located at the forward 1/3 of the device body 102. Such a configuration allows ease of operational handling with the physician's index finger or thumb, Again although the illustration shows a rocker switch, other single switchnmiltiple switches, and/or multi-function switch styles are suitable for the implementation of this aspect of the invention,

[00901 FIG. I also shows the working end 104 of the device.100 comprising a single axis probe. While the examples illustrated below comprise an electrosurgical energy modality, other energy modalities can be used in combination or in place of the electrosrgical modality, For example, such modalities can include: cooling, cryogenc, thermal RF, thermal (resistive heating), microwave, focused or unfocused ultrasound, thermal or non-thermal DC, UV, radiation,as well as any combination thereof, can be employed to reduce or otherwise control the ability of the nerve to transmit signals. FIG. I schematically illustrates the device 100 being coupled to a power supply 150, which can provide the energy modality required to perform the treatment as well as the stimulation energy used to locate a nerve, Additional variations contemplate a separate power supply (not illustrated) to power/control thestimulation eney.In additional variations, the handle 1.00 can contain the power supply. The term power supply is intended to include units where a controller regulates delivery of energy from the power supply. Accordingly, the power supply 150 described herein can include a controller. Alternatively, the controller can comprise a separate physical unit.

[0091] The devices described herein can also employ various features to provide feedback to the medical practitioner. For example, FIG .1 illustratesa feedback indicator that can provide feedback to the medical practitioner. The feedback can be visual, tactile., vibratory, audio, or a combination thereof. Although the illustrated variation shows the feedback indicator 120 towards a distal end of the device body 102 variations of the device allow for an indicator that canbe located on any portion of the device 100and/or on multiple locations of the device, The feedback can comprise anindication of generator status, number of treatments, whether the device is within an acceptable range of a target nerve or ablation site

[00921 FIG I also illustrates an exemplary working end 104 of the device 100. As discussed herein, the working end typically includes a single axis probe 105 that has a distal end 106. In certain variations the distal end 1.06 includes a tip for a allowing penetration of the working end. 104 into tissue. Alternatively, the distal end 106 can comprise a blunt shape that permits penetration of the working end 104 into tissue but nminizes undesirable collateral damage to issue, The working end 104 willalso include one or more energy delivery regions 106,108, 110. For example, when the energy modality comprises an electrosurgical device, the working end 104 can include one or more electrodes 106, 108, 110 that are electrically isolated to pass current in a bi-polar or mono polar manner.

100931 Any of the probes disclosed herein may include an illumination source 1.07 such as a fiber optic illumination, a light emitting diode, a laser source for assisting the physician in identifying the location of the percutaneously placed working end through tissue. The illumination source can be powered through the controller/powersupply 150 or can be powered by a source in the device body 102 itself

10094] FIG 2 illustratesanothevariation of atreatment device 100 coupled to a reservoir delivery member 170. The device can also include a cable 122 or other connector that couples the device 100 to a controller/power supply 150. In the illustrated variation., the connector comprises a hub 124. However, alternate variations allow for a device 100 that is directly wired to the controller 150. The variation shown in FIG. 2 also depicts the reservoir 170 as being a separate syringe. However, alternate variations of the device include reservoir that is fluidly coupled to the working end 104 through the hub 124 or cable 122 of the device 100. In such cases, there will be a means to pressurize orinitiate flow of the substance within the reservoir. The reservoir 170 is typicallya fluid source but variations include injectable particulates, gels, or othernon-fluid injectable materials. The reservoir 170 can deliver any type of fluid to the working end 104 of the device 100. In the illustrated example, thereseoir170comprisesasyringewithaplunger. Aterate variations include reservoirs coupled to electronic or automated dispensers.

100951 Typically,thesubstanceinthereservoir170comprisesanaestheticsoution, cooling solution, conductive fluid, drug, cosmetic agent, and/or any other bio-active agent. Variations ofthe device and methodincItide delivery ofmultiple substances through the device or to the target location. For example, a saline solution can be delivered to the target location to adjust the impedance of the tissue while an aesthetic agent can be delivered before, during, orafter delivery of the saline fluid, As described below, the reservoir 170 is in fluid communication with ports at the working end to permit delivery of the .uld at or near the treatment site,. The substance can be dispensed at any time, including during penetration of the tissue, during movement within tissue, and before/duringaafter stimulationaind/or applicationofenergy. The substance can be a controlled volume that dispenses each time or can be an adjustable volume that dispenses based on the physician's preference. Moreover, dispensingcan occurautomaticallyprior to, during, orafter treatment.

[00961 FIG 2 also illustrates the conttroller/power supply 150 as havingavisual display 150. The visual display can provide treatment information to the physician as well as device information.For example, the system can provideinformation regarding the number of applied treatments; the system can provide information regarding whether the treatment was successful (e.g, whether the target siteheld a pre-deternined temperature and for how long). The system can also provide information on temperature and time profiles for each treatment. For example, in one variation the controller contains multiple pre-determined delectable treatment settngseg.80 degrees. 70 degrees, and 85 degrees F)and attempts toehold the ireatnent site at these temperatures for a predetermined time (e.g 30 second). In some variations physician can detennine which setting to use based on the location of the target site or if the skin is very shallow or thin at the target site. The controller can also establish a cutofftemperature above which treatment ceases. In one example the cutoff temperature is 93 degrees F but can be as high as 130 degrees F). The controller can also check for temperature during treatment, and. if no rise in temperature is observed., the controller can either cease treatment or can apply a low amount of power. Additional safety measures can be employed suchas establishing a step-up to the target temperature through anumber of intermediate temperatures (e.g, x degrees above body temperature per unit time until the target temperature is reached). Furthermore, the system can monitor impedance and establish maximum mpedanceat which the treatment stops. in one example, the system can monitor for impedance between 100and 500 ohms with a shutoff of about 2000 ohms.

100971 The variations shown in FIG 2 also includes a contored or ergonomic device body 102, which as described above, is suitable for singlehanded operation of the device 100 with the device body 102 being balanced in the web of a user'shand between the thumb and the index. finger. This positioning allows the user to positiona single finger on switch 112 to activate the switch 112 in a forward 116 or rearward 114 direction to adjust the stimulation settings of the system As noted above, in certain variations,theforward 116 and rearward 114 movement allow for adjusting, of the stimulation strength of the device 100 and. upon properly identifying the target location, the user's finger can select trigger 118 to apply the stimulation energy to identify the nerve. Once the physician identifies the target site, the physician can operate any number of switches 152, 154 as well as the combinations discussed above to commence treatment of the desired region oftissue.

[00981 FIG.3A illustrates one variation of a working end 104 of a single axis probe 105 having at least one energy transmitting region with sensors and/or fluid delivery ports positioned in the working end 104.The variation shown in FIG. 3Aincludes a first or distal energy transmtting region 122 and a proximal transmitting region 124, For example, the two energy transmitting regions 122, .124 can comprise electrodes of opposing polarity when using an RF energy supply. As shown, the two electrodes.122 and 124 can be positioned such that they are on either side of delivery ports 132 that extend through a sleeve 130 or similar structure that defines a fluid delivery lumen in fluid communication

1'7 with reservoir (as shown in FIG, 2). Optionally, a sensor 126 (suchas a temperature detecting element) can be positionedadjacent to the energy transmitting regions.122 and 124.

[0099} The configuration shown in FIG, 3A permits delivery offluidsand/or substances in a central region to the intended target area, The device can includeany number of fluid ports 132 includes froma single fuid port toa. plurality circumferentially positioned around the device or simply limited toa single side of the device, Thevariation depicted in FIG. 3A shows a plurality of fluid ports 132 that are oriented to directflow in a radial outward direction relative to a central axis of the singleax probe105.Onebenefit of positioning the ports 132 in close proximity to the energy transfer units is that the substance can be delivered directly to the area of tissue targeted during the procedure.

[01001 FIG. 3B illustrates another variation of a working end 104 of devices described hereir. In thisvariation, energy transmittingregions122, 124 are separated by anon energy transmttig region130 and afluid delivery port 132 that is an opening to an annular passageway within the probe 105. FIG. 3B also illustrates that one or more sensor elements 126 can be placed between the energy transmitting regions 122, 124. In certain variations, the sensor elements 126 will be placed out of a flow-path of the ports 132 so that substances exiting the port 132 do notaffect the readings of the sensor 126

[01011 FIG.3C showsan example of a device 100 positioned in tissue 10 where the energy transmitting regions 122 and 124 create a lesion 12 within the tissue 10. The illustration depicts application of an RF current 136 between the two regions 122, 124 however, as notedabove, any energyrmodality can be applied which results in a lesion or treatment area 12 being formed about the energy ransmitting regions 122 and 124, The depicted example illustrates the state of the device 100 after the physician identifies the proper location for treatment (e.g.,after the stimulation modeidentifies a suitable location for treatment). FIG. 3C also shows delivery ofasubstance 134 through the ports 132, In the illustrated variation, the ports 132 permit delivery of the substance in a direction that is radially away or normal to an axis of the probe 105. As discussed above, additional configurations are within the scope of this disclosure including combinations of ports oriented to deliver the substance in different directions on the same device. Regardless, the substance can be delivered prior to, during-Of subsequent to application of the treatment modality. In addition, positioning of the ports 132 adjacent to or between transmitting regions122 and 124 allows for targeted delivery ofthe substance tothe treatment area.

18s

10102] For example, in cosmetic applications it may be desirable to deliver a numbing agent to the region.-in such a case, once a physician determines the proper placement ofthe working end of the device, the physician can deliver thenumbing agent from the reservoir through the ports to the region of tissue to be treated. The close proximity of the ports to thetargetareaallowsrminimizing the amount of substance that must be delivered. Minimizing the amount andior spread of the numbing agent is desirable since the numbing agent might impair a muscle's ability to respond to nerve stimulation, 101031 As noted herein, the devices can includeany number of ertergy modalities to provide the therapeutic treatment. Accordingly, the energy transmitting regions 122, 124 shown in FIGS. 3A to 3B are not limited to R-Fenemy electrodes. In additional variations, the regions can comprise cooling regions, cryogenic fluids., thennal RE resistive thermally heated regions, microwave antennas, focused or unfocused ultrasound transducers, thermal surfaces powered by a DC current, UV radiation, as well as any combination thereof In those variations relying on a Radio Frequency energy supply, the two energy transmitting regions 122, 124 can comprise electrodes of opposing polarity. Regardless of the energy type used, it can be desirable to position a sensor 126 (or other sensor) between the transmitting regions 1.22,124. However, alternatively, orinaddition, one or more sensors can be positionedalong the probe 105 or onany other portion of the device.

[01041 FIGS, 4A to 4G illustrate use of devices and systems described herein when used to perform a treatment in a patient, The example shown illustrates use of the device 100 toablate one or more regions and/or branches of a temporal nerve which controls movement of facial muscles, However, it is understood that the methods, features, and aspects described herein can be applied to any nerve structure controlling any observable/measurable body function,

[01051 FIG 4A is intended to illustrate afeature of a system similar to those discussed herein where the treatment device 100 can be operated in a dual purpose mode to provide nerve stimulationand therapeutic treatment. In one variation, the stimulation function passes pulsed direct current between the energy transfer surfaces 122 124 in theworking end 104 of the probe 105 to operate in the nerve stimulation mode. In additional variations, the nerve stimulation mode can providealtemating current (or RF generated current) to identify nerves via muscle as known by those skilled in the art. Regardless, when used in a stimulation mode, the workingend 104 of the device 105 applies current to the tissue to stimulate the nerve which produces movement in the muscle that the nerve is controlling.

This movement can physically observed (e.g by feeling for the movement ofmuscle), orvisually observed(ea whe the physician stimulatesand observes which muscle or which part ofthe face hasmovement).Moreover, any number of pacing devices or camera devices can be used to detectmovement

[01061 The device 100 can operate in a plurality of settings that stimulate the nerve. As longas the working end of the device is sufficiently close to the nerve, where the distance is dependent upon parameters of the applied current (e.g.,amount of current or the amplitude of the current). Cycling of the current causes contraction and relaxation of the muscle which can be observed by the physician or by other sensingidentifying means. The amplitude of the current can be adjustedfrom the probe body or from the controller. The intensity of the stimulation is directly related to the amplitude of the currentand the proximity to the motor nerve. As the physician gets closer to the nerve he/she can reduce theamount of stimulation current and still observe muscle contraction. When the stimulation current slow («,7mA) and muscle contraction is observed, the probe electrodes are in close proximity to the target motor nerve. In.one working example, it was found that the low stimulation current (eg., 7 milianps) produced stimulation ofnerves within 2 mm of the device's working end. Knowingthatthedeviceiswithinacertainrange of a nerve permits the system to apply energy that will have an effect within that range.

[01071 For example, in the current example, if thenerve/musclebecomes stimulated using the threshold stimulation energy (e.g, the low stinmulation current), then the physicianand/or sensing identifying means will confirm that the working end of the device isplacedwithinaneffectivedistance/raneof the target tissue (e.g, the nerve) to apply the therapeutic energy in acontrolledmanner without producing undesirable collateral damage or encompassing tissue that is well beyond the target tissue. In one variation, stimulation using the threshold stimulation energy/current allows the system to apply stimulation energy while delivering therapeutic energyand maintaining a pre-determined target therapeutic temperature fora preetermined amount of time, The physician and/or sensing identifying means will confirm that a effective therapeutic endpoint on the target tissue (i.e. nerve) has been reached, It is understood that the design of the electrodes or treatment areas can affect the range (including lesion size, shape, volume, andisothens) of the deviceas well. After location the motor nerve, radiofrequency energy is applied through the same electrodes to heat the tissue and inhibit nerve function. Once an RF lesion is placed on the-nerve communication between the brainand the muscle is disruptedand the patient canno longer actuate the muscle.

[0108] FIG. 4A represents the effect of two parameter settings in the stimulation mode, In the first parameter setting, the device 100 can stimulate nerves in tissue at a first distance 142. At the second parameter setting, the device 100 stimulates nerves at a second distance As shown in FIG. 4A, the first distance isogreater than a second distance. Such functionality allows the physician to operate the system at the first parameter setting to generally locate the target nerve. To position the working end 104 of the device 100 closer to the target, the physician changes to the second parametersetting and checks for contraction and relaxation of the muscle governed by the target nerve. Because the stimulation range 140 of the device 100 is limited, stimulation of the target umscle confins that the working end 104 is close to the target site on the nerve, If the physician operates the device 100 at the second parameter setting and does not observe anymusclemovement, the physician will know that the working end is not optimally positioned relative to the nerve. Clearly, the systemcan include any number of parameter settings. Moreover, the ranges 140 and 142 are for illustrative purposes only. In one working example, the second pammeter ranges approximately.7 milliamps and corresponds to a range 140 of less than 2 mm- Again, the parameter levels and ranges can be adjusted depending upon the application, area of tissue, degree of stimulation required, etc. In anothervariation of the device and system, the controllerpower supply (and/orlfeatures on the device 100itselfl) prevent the device from operating in the therapeutic mode tmess the device is toggled to the second parameter setting corresponding to a smaller stimulation range 140.

10109] In another variation, instead of being prevented from applying treatment, the system can provide warning to the physician that thestimulationmode is not in a preferred mode toapply therapeutic treatment. Accordingly, the system can require a physician override so that the physicianpurposefully performs the therapeutic treatment

[01101 FIG. 4B illustrates a temporal nerve branch 14 and an access point 20 where a physician advances the probe 105 of the device 100 to position the probe underneath skin and adjacent to the targetnerve.As discussed herein, variations of the invention can use a single axis probe to minimize the entry wound 20 and to accurately trace along the nerve 14. i alternate variations, a multiple axis probe can be used with the varying parameter functionality discussed. herein.

10111] FIG, 4C illustrates a working end 104 of the device being advanced through the access opening 20 towards thenerve14. As shown, the device can operate in a first parameter setting such that the stimulation distance 142 is sufficient to allow the physician to generally locate the nerve responsible for a particular muscle. Opening 20 is not limited to the location as illustrated. The probe can accessany part ofthe body as needed

[0112j During the process of probe placement, the stimulation current level may be increased or decreased as described by sequentially depressing one or more switches on the device (see FIGS. I and 2 above), A speaker associated with the system may emit a tone having a volume or frequency or other sound and/or visual attribute substantially proportional to the amplitudesetting of the stimulation current with each switch closure. This feature permits the practitioner to adjust the stimulation level without the necessity of adjusting any level dials or switches associated with the generator, allowing the practitioner to focus on critical probe placement.

[0113j In one variation,as the physician locatesthe nerve 14 thephysician canadiust the system to the second. parameter setting thereby lowering the stimulation range 140.As illustrated, stimulation of the nerve 14 when inthe second parameter setting shall inform the physician that the energy transfer portions of the working end are sufficiently close, immediatelyadjacentand/or contacting the desired target area 30

[01141 FIG. 4D represents the reduced stimulation range 140as the device is operated in the second parameter setting, Upon observing muscle movement, the physician can enter the therapeutic mode of thesystem by operating the switch that applies the therapeutic energy/treatment (described above) without moving the device. Oncein the therapeutic mode, the physician can ablate or otherwise treat the target area 30, As noted above, because stimulation ofthe target nerve occurs when using the threshold current the system can effect treatment of thenerve by applying a pre-deternmined amount of therapeutic energy that has a known effect on the tissue (either controlling for a specific temperature and/or time as described above), In certain variations, the pre-determined amount of energy is set to ensure that the therapeutic effect does not extend beyondthethresholdstimulation range of the device (i.e, the range of the device when using the threshold energy,e.g range 140 of FIG. 4A).

101151 Inanadditional variation, the system can treat the target area 30 using a setting that producesimuscle contraction or stimulation during the therapeuticapplicationof energy. Accordingly, the physician can observe stimulation of the associated muscle during treatment. Insuch a variation, the physician can confirm the treatment when the associated muscle ceases movement.ft is believed that twitching of muscle occurs when nerves enervatinga muscle are depolarized, If the frequency is sufficiently low (e.g,60z then nerves can be depolarized directly,

[0116j FIG. 4E depicts the physician advancing the working end.104 along the nerve 14 through the same opening 20 and. also depictsanother feature of the system where the deviceand/or controllerpower supplyautomatically readjusts or switches to the first parameter setting corresponding to a greater stimlation range142asopposedtothe reduced stimulation range 140 of the second parameter setting. As noted above, in certain variations, when the system is in thefirst parameter setting the system prevents a use from applying therapeutic treatment. In certain variations, the system can only apply therapeutic treatment when in the second parameter setting. One benefit of this feature is that the physician,havingmoved the device from first treatment site 30 towards second treatment site 32, must affirmatively readjust the parameter settings to the first parametersettig to ensure that the energy transfer surfaces of the working end are sufficiently close to the intended nerve and/or target site 32. FIG. 4F shows the device 100 where the physician reselects the second parameter setting corresponding to the reduced stimulation range 140 Once the physician positions the device through identification of associated muscle movement, the physician canapply the therapeutic treatment without moving the device. As shown, the second location 32 is along an.aginary longitudinal axis of thenerve dismally to the more proximal location 30. Such "proximal to distal" directional ablation alongthe longitudinal axis of thenerve is believed to increase the effect of the duration of treatment.

[0117j FIGv 4G illustrates a variation of a treatment procedure where a physician identifies and creates treatments at three locations 30 32 34. For clarity, theillustration shows the working end 105 being withdrawn through tle access point 20, The illustration alsoshows a distinctive feature of the dual-purpose probe that providesan ability to create multiple lesions 30, 32, 34 on the same nerve or within a region of nerves that control one or more muscles that require treatment, In the illustrated example, the physician creates an initial lesion 30. This initial lesion disrupts communication to the nerve but the section of the nerve from lesion 30 to themuscle (denoted byregion 22) remains intact. This intact region of the nerve allows the physician to continue using the stimulation function of the probe to further simulate movement of muscle region 22 by moving the probe ina distal direction (ie. in a direction closer to the muscle region 22 along the nerve). Movement of the device in this manner permits the Physician to precisely relocate the device on thesame nerve (or on a different nerve branch that controls muscles requiring treatment).As long as the probe tip advances distally along the nerve from the initial lesion (toward themuscle) the physician can locate thenerve through stimulation and observation as discussed above. In the illustrated example, the lesions are created in three sequential processes with the initial lesion 30, the next lesion 32 and final lesion 34 being formed in succession. The stimulation mode causes muscle contraction as long as the probe is distal to the last lesion.

[01181 The process of relocating the nerve andapplying multiple lesions on single nerve can be applied to ensure long term effect of the treatment. Multiple lesions along the same nerve (or same nerve region) increase the longevity of effect given that the nerve must heal in three locations prior to being able to relay signals. Itis believed that multiple lesionsassist in the longevity of the duration of the treatment since, it is believed that, nerves heal proximal to distal Meaning that the most proximal nerve injury (e,g, 30) will most likely heal allowing communication to bere-established along the nerve prior to the more distal nerve injuries (i.e, 32 and 34).

[01191 In another variation, as shown in.FIGS. 4A to 4G, a method for creating mudiple lesions on the same nerve include using externalstimulation device and map nerve location to get rough indication of nerve location. Then the physician inserts the probe or device probe into tissue. The physician then uses the stimulation function, to locate the target nerve. i variations, the stimulation function is automatically set to aparameter setting that increases a stimulation range of the device butalso prevents the device from firing the therapeutic/ablation treatment. The physician wilRthen adjust stimulation current to precisely located nerve and confirm muscle contraction. Assuming the stimulation parameters are set to reduce the stimulation range of the deviceand the physician confirms positioning of the probe via observation, the physician can then initiate the therapeutic mode of the device (e.g. by applying energy to affect the ability of the nerve/tissue to transmit neural signals, or ablating thenerve/tissue) In certain variationsthe system will automatically reset to the first parameter stimulation settings., whichincreasesastimulation range of the device and prevents the device from activating in the therapeutic mode. Next the physician can optionally advance the probe to a new location distal to the initial lesion andwill repeat thestulationandtreatment, Thephysician can repeat the subsequent treatments alone the nerveasdesired to create any number of lesions.

[0120] Variations of the device include at least three parameter settings where two parameter settings correspond to a much reduced range of stimulation than the third parameter setting, Isuch a case, the two reduced parameter settings can correspond to a first acceptable range and a second finer range. Such a setting would allow a physician to locate the device relative to a nerve with varying degrees of accuracy.

[01211 FIG. 5 illustrates anotherfeature of the dual function device 100. In this variation, the fluid ports located on the device deliver a substance.134 between treatment portions.122 124 of the device. In the example, thesubstance comprises an anesthetic or numbingagent to createa limited /one 44 of effect (as illustrated by the shaded portion of FIG, 5). One benefit of this configuration is that application of a numbing agent over a larger area cartpotentially interfere withthe ability of anerve to stimulate the muscle, Accordingly, if the numbing agent affects the nerve so that it can no longer triggermuscle movement, or if theareas of the nerve distal to the first treatment site cannot be stimulated, the effectiveness of the procedure might suffer. Variations of the procedure include delivering the numbing agent before, during and/orafter the stepof applying therapy. In certain cases it is desirable for the patient tomaintain motor control over the muscles being treated since the physician canask the patient to ontract the muscle, Contraction of the muscle allows the physician to determine the progress of the treatment. In such cases it can be undesirable to blanket the face or muscles with an anesthetic since the patient will be unable to contract his/her muscles.<Examples of numbing agents include dilute lidocaine I or 2 percent, lidocaine with epinephrine, and septocaine, However, any numbing agent can be used.

[01221 FIGS. 6Aand 6B illustrate various additional examplesof creating treatment sites to effecta therapeutic benefit. FIG. 6 illustrates afirst lesion 30 on a proximal or nvain branch of a nerve with a second 32, third 34, and fourth 36 lesions on separate branches of the nerve 14. As discussedabove, the sequence of the ablation sites is based on a proximal to distal. direction away from the insertion point, or towards muscle). FIG. 6B shows an example of a treatment of multiple lateral nerve branches. As shown in FIG. 6B, a variatio of the procedureincludes applying lesios to "lateral" branches of the primary nerve proximal to the muscle. The desired. effect., ofinhibiting nerve function, therefore eliminating hyperdynamic facial lines (wrinkles) caused by the muscle activity, can be achieve by applyinga single lesion tomultiple nerve branches of the temporal nerve. Although notrequired the first lesion 30 is positioned closes to the access point 16 and farthest from the target muscle, the second. lesion 32 is formed distal to the first lesion. 30 and the third lesion 32 is formed distal to the second 32where each lesion is ona different branch of the temporal nerve 17

[01231 FIG. 6C illustrates another example of lesions 30 being created on theanguar nerve in a manneras described herein. As notedabove, the methods and devices ofthe present disclosure can be created in any number of areas of the body and along anynumber of nerves.

[0124] FIG. 7 Alternate variations of BiPolar Driver System

[0125_ FIG. 7 identifies the two required components of the system, various modules andoptional items. The twocomponentsalways utilized duringaprocedure will be the energy enerator/controllet/datastorage device 400 and probe 37L 400 contains advanced electronic systems capable ofrecognizing a properly authorized probe, preventing re use of a previously used probe, generating appropriate energyas described, performing safety checks, storing data, and other functions as described Main functions of 40 may inchde, butnot be limited to,generation of lght, generation ofocation-stiuationcurrents, generation of ablation energies. data logging, storage, communication and retrieval, and other functions critical to a MIS procedure. Probe 371 and its various forms are single puncture bipolar surgical tools that may be used in identifying proper'location of its tip 301, in relation to target issue 101 which is desired to be ablated, modified or destroyed. Probe 771 and its various derivativesimay optionally be used to assist in locating and properly positioning tip 301 of probe 371

101261 FIGSA and 8B isometric View of the Bi-Polar Probe

101271 Bi-polar probe 310 represent probes 371,372 373 shown in FIGS- 9A-9C with exception to type of needlepoint on. the probe. FIG 9D varies front the other because it has asplitreturn probe. Bi-polar probe 310 (not drawn to scale) consists of insulating dielectric body 309 made from a suitable biology inert material, such as Teflon, PTFE or other insulativematerial covering electrode 302 except for where 302 is exposed as a return electrode. Conductive return electrode 302 tube is fabricated from medical grade stainless steel, titanium or other conductive material Hollow or solid conductive tip electrode 301 protrudes from surrounding dielectric insulator 305 Sizes of 309, 302, 305, and 301 and its

'26 inner lumen (diameter, length, thicknessetc.) may be adjusted so as to allow for different surface areasresulting in specific current densities as required for specific therapeutic applications.

[01281 Hollow Electrode 301 often used as a syringe to delivermedication such as local anesthetic. Tip electrode 301 is connected to power amplifier 416 via impedance matching network 418 (FIG. 10)..Return electrode(s) 302 delivers'return current to power amplifier 416 via impedancematchingnetwork 418. Dielectric insulator in the disclosed embodiment is a transparent medicalgrade polycarbonate acting as a light pipe or fiber optic cable. Light source LED or laser 408 (FI. 10) provides illumination at the far end of the probe via fiber optic cable/transparent dielectric 305 for guiding the probe under the skin i.e. shallow procedures.In an alternate embodiment dielectric insulator is replaced withaplurality ofoptical fibers for viewing and illumination as taught in FIG 12A,

[01291 Ablation regions 306 and 140 extendradially about electrode 301 generally following electric field lines. For procedures very close to skin 330 a chance of burning exists in region 306, To minimize the chance of burning,a splitreturnelectrodeprobe374 in FIG. 9D is offered. Thereby concentrating the currentaway from region 306 to 140 or vice versa. In FIG. SA, insulator 307 splits the retum electrodeinto two sections 302 and 30)3, dividing return current ratio from 0-50%, which may also be selectively activated. Active electrodes are also split into two sections 301 and 311 so energy may be directed in a desired direction. This electrode configurations identified on the proximal portion of the probe so the operator may position the needle and electrodes accordingly. FIG. I2A teaches a laser directed ablation for more precise energy delivery.

10130] FIG. 8A Isometric View of Split Bi-Polar Probe.

10131J The bi-polar probe 380 (not drawn to scale) consists of an insulating dielectric body 309 made from a suitable bioloically inert material,such asTeflonPTFE or other electrical insulation, that covers split return electrodes.302 and 303- The disclosed conductive return electrodes 302 and 303 are fabricated from medical grade stainless steel, titanium or other electrically conductive material. Hollow or solid split conductive tip electrodes 301 and 311 protrude from thesurrounding dielectric insulator.305. The operation of the hollow/split conductive tip is very similar to probe tip 310 as taught in FIG. 9D Ablation regions 1203 (FIGS 10.) and 140-144 extend radially about electrode 301 generally following electric field lines, For procedures very close to skin 330 a chance of burning exists inregion 306. To minimize chance ofduring a split return electrode probe31 is used, thereby concentrating the current away from region 306 to 140. For procedures where there is a risk to nearby structures 111, the ablation region 1203 must be a non-radial ablation zone The disclosed split electrode 380 permits dividing or splitting energy delivered to electrode pairs301/302and311303Thediscloseddivisionorratio between pairs is 0-100%. Dual amplifiers or timemultiplexin/switchingmain amplifier, 416 located between electrode pairs, directs energy to target 101 avoiding I ll.This simple switch network reliably ratios electrical energy while minimizing damage to nearby structures.

[0132l FIG. 9A Conical Bi-Polar Needle

[0.331 Bi-polar probe 71discloses conical shaped electrode 301 and tip31.for initially invasive single point entry. Probe diameter358 is similar to a 20-age or other small gauge syringe needle, but may be larger or smaller dependingoan the application, surface area required and depth of penetation necessary. In disclosed embodiment, electrode shaft 302 is 30 mm long with approximately 5 mm not insulated, Lengths and surface areas of both may be modified tomeet various applications such as in cosmetic surgery or in elimination of back pain. The conductive return electrode 302 isfabricated from medical grade stainless steel, titanium orother conductive material The dielectric insulator 305 in the disclosed embodiment is a transparent medical grade material such as polycarbonae, which may double as a light pipe or fiber optic cable. The highintensity light source 408LED/laser (FIG.10) provides guidance Illumination 448 at working end of probe. The illumination source modulation/flash rate is proportional to the received stimulation current 810 as taught in FIG. 8, A small diameter electrode permits a minimally invasive procedure that is typically performed with local anesthetic, This configuration may contain lumensfor delivery of agents as described elsewhere.

[01341 FIG. 9B Hollow Chisel

[01351 The hollow chisel electrode 352 is often used as a syringe to deliver medication such as local anesthetic, medications,/tracer dye, The hollow electrode may also extract a sample. Dielectric insulator 305 in the disclosed embodiment is a transparent medical grade polycarbonate and performs as a light pipe or fiber optic cable, The novel dual-purpose dielectric reduces probe diameterand manufacturing costs, Light source 408, typicallya LED or laser (FIG. 10 not shown), provides illumination 448 at the working end of probe.

It provides an illunination source for guiding the probe under the skin. A second embodimentas taughtin FIG. 12A, dielectric insulator is replacedcombined with plurality of opticalfibers for viewing/llumination.

[01361 FIG. 9C Tapered Conical

[01371 The bi-polar probe 373 discloses a tapered conical shaped probe for minimally invasive single point entry It is constructed similarly to probe 371 as taught in FIG 3A. Probe tip is not drawn to scale to teach the tip eometry. In disclosed embodiment., electrode 301 isapproximatel 5 mm longand fabricated from medical grade stainless steel but may be of various lengths to accommodatespecific application andsurface area requirements.Thesolid tapered conductive tip electrode 353 protrudes from tapered dielectri.c insulator 305.Transparent dielectricinsulator 305 also performs as light pipe or fiber optic cable terminated to high intensity light source 408 (FIG. 7) providing illumination 448. The electrode assembly is mounted in an ergonomic handle 388 (which has not been drawn to scale). Handle 388 holds ablation on/off switch 310, ablation/stimiulation mode switch 367, identification module 331 and terminations for cable 1334 (FIG 73). Temperature sensor 330 (located close to tip) monitors tissue temperature

101381 FIG. 9D Split Conical Bi-Polar Probe

{01391 Description of this probeis described in both drawings£83and9Dipolar probe 374 (not drawn to scale) consists of insulating dielecticbody 309 made from a suitable biologically inert material, such as Teflon, that covers split return electrodes 302 and 303, Conductive return electrodes 302are fabricated from medical grade stainless steel, titanium or other suitable conductive material. Hollow or solid split conductive tip electrodes 301 and 311 protrude from surrounding dielectric insulator 305 Their operation is very similar to probe tip 380 astaught in FIG. A, Solid tapered conductive tip electrodes 311 and 301 protrude from transparent dielectric insulator 305. Dielectric insulator 305 also performs as a light pipe or fiber optic cable terminated to highintensity light source 408 providingillumination 448.

[01401 Probe handle (not drawn to scale) encloses memory module 331, on/offswitch 310 and mode switch 367. Temperaturesensor 330 located close to tip) monitors tissue temperature. Split electrode 380 (FIG8A) permits dividing or splitting energy delivered to electrode pairs 301/302 and 3115303. Dual amplifiers or time multiplexing/switchingmain amplifier 416 are located between electrode pairs directing energy to target 101 avoiding

29k

I tIcreating asymmetric ablationvolume. A small diameter electrode needle is injected Zroma singlepointofnt minimizing scaring and simplifying precise electrode placement.

[01411 Connections consist of a tapereddielectric sleeve 309 covering the ridged stainless electrode tube 302. Insulating sleeve 309 is made from a suitable biologically inert material, which covers electrode 302. Dielectric 305 insulates conical tipped electrodes 351 and 30l

[01421 FIG. I IA Ablation Procedure (Without Auxiliary Probes)

101431 Ablation probe 371 is inserted and directed anatomically into the areawhere the target nerve to be ablated (Box 531) is located. Test current 811 is applied (Box 532). If probeis located in the immediate proximity of the target nerve a physiologicalreaction will be detected/observed (Example: During elimination of glabellar furrowing, muscle stimulation of the forehead will be observed), If reaction is observed, then mark nay optionally beapplied on the surface of the skin to locate the area of thenerve. Power is applied (Box 535) inan attempt to ablate thenerve. If physiological reaction is not observed, (Box 534) the probe will be relocated closer to the targetnerve and the stimulation test will be repeated (Box 536 & 537). If no physiological reaction is observed, the procedure may be terminated (Box 544). Also, the probe may be moved in any direction, up, down, nearfar, circular, in a pattern, etc. to create a largerarea of ablation for a more permanent result.

.01441 In Box 537,if stimulation is observedagainthen the ablation power maybe set higher (Box 538). alternatively, as mentioned, the needle may be movedin various directions, ora larger dosage of energy may be reapplied, to form alargerarea of ablation for more effective or permanent termination of signal conduction through the nerve, Ater delivery of power (Box 540, stimulation energy may be applied again(Box541). If there is no stimulation, the procedure is completed (Box 544). If there is still signal flow through the nerve (stimulation or physiological reaction) then the probe may be relocated (Box 542) and the procedure isstarted over again (Box 533).

[0145 FIG. IIB Flow Chart of Visually Guided Ablation Procedure Using Auxiliary Probes Such As 771 and 772

101461 Auxiliary probes 771 and 772 (FIGS. 3A and 1313) provide a method to quicklyand accurately locate target structure 101 and subsequently mark targetlocation

3o

755. Auxiliary probes may bemuch smaller (like acupuncture needles) thanablation probes. Stuctures are marked typically withan ink or similar penallowing the illuminated ablation probe 371 or other ablation probe to be quickly guided tomark 755 Optionally, non-illuminated probesimay be usedallowing the practitioner to simply feel for the probe tip. For deep structures, probe 771 (FIG. 8) us employed as an electronic beacon. Small current 811, which is similar to the stimulation current but smaller, from probe tip 702 is used to guide ablation probe 372 (FIG. 8).

10147] Operation 530 (FIG,113B) insertsauxiiary probe 771 or 772 (FIGS 13Aand 13B) thru skin.330 and muscle layer(s) 710 near nerve 101. Target 101 depth 766 is measured (FIGS. 13A and 1133) using auxiliary probe markings 765. Decision 533 checks if the probe is in position if not adjustments are performed in 534. Operation 532 enables nerve simulation current 811. Whenimuscle stimulation is obtained or physiological reaction is obtained, Auxiliary probe tip is in place. Depth may berioted byreadingmarks 765 and location marks 755 may be made in operation 535 With the probe in position under mark in operations 536 and 537, operation 538 sets powerlevel 404and closes ablation switch 410. Alternatively, stimulation may be applied directly from the ablation probe as taught elsewhere Operation 540 and controller 401 set generator 411 (FiG. 7) frequencies, modulation 420 envelopeand enables power amplifier 416 to deliver preset ablation energy. Region 1203 (FIG. 10) shows the general shape of theablation region for conical tip 301 for example,

[01481 Between each ablation, procedure 540 (FIG. I IA) (nerve conduction) is tested in 541. Probe amplifier 416 delivers small nerve stimulation current 811 from electrode 301 or Auxiliary probe 771 or both. Based on the nerve conduction test 541 if the desired level of conduction is achieved the procedure is compete. Operation 542 moves the probe to the next position and repeats conduction test 541 If compete, the probe(s) is removed in operation 544. Number and ablation intensity/energy are set by the particular procedure and the desired permanence, The practitionerselects the procedurepower level 404 (FIG. 7) and controller 401 compares the installed probe viaidentification 331 (FIG. 7) for compatibility with selected procedure, The practitioner is alerted if the installed probe is incompatible with selected power range 404,

101491 Asan example and not a limitation, five ablation regions (140, 141,142, 143, and 144) are shown in FIG. 10. Ablation starts with area 144, then the probeis moved to 143 and so on to 140. Alternatively movement may be during insertion, moved laterally, in a circular manner or other manner to enlarge the area of targeted nerve destruction. Nerve responses may be tested after eachablation allowing the practitioner to immediately check the level of nerve conduction. Probe position and poweradjustmentsaremade before applying additional ablations ifrequired, Accurate probe location tools and methods taught herein permit use of minimal ablation energy thereby iimiuing damage to non-target structures. This translates to reduced dealing timeand minimal patient discomfort. The instant inventon gives the practitioner a new tool to perform a minimally invasive nerve conduction limiting procedtire with the ability to select, temporary or permanent nerve conduction interIption with a new level of confidence, This newtool offers a low cost procedure performed typically in office or outpatient setting often takingless than one hour with local anesthetic. In contrast to prior art where surgical procedures require stitches and longer healing intervals with limited control of perimanence (nervere-growth).

[01501 Auxiliary probes 771 and 772 (FIGS 3A and 13BA) haveaccurately located target structure 101 and subsequently marked target locations 140 to 144. Shallow structures are marked typically with ink pen (755) allowing illuminated ablation probe 371, 372 or equivalent to be quickly guided to that point. For deep structures, probe 771 is employedas electronic beacon, small current 811 from probe tip 702 is used to guide ablation probe 372 as taught in FIG. 14.

[01511 Ablation probe 372 is inserted thru skin 330andmuscle layer(s) 710 near nerve 101. Illuminationsource 408 permits practitioner toquickly andaccuacy guide illuninated 448 ablation probe 372 into position. Illumination 448 from ablation probe as seen by practitioner 775 is usedasanadditional aide in depth estimation, Selectable nerve simulation current 811 aids nerve 101 location within region 1204, This novel probe placement system gives practitioner confidence system is working correctly so s/he can concentrate on the delicate procedure. Accurate probe location permits use of minimal energy during ablation, minimizing damage to non-tarnet structures and reducing healing time and patient discomnolrt.

101521 Region 1203 shows the general shape of the ablation region for conical tip 301L Tip 301 is positioned in close proximity to target nerve 101. Ablation generally requires one ora series of localized abliations.Number and ablation intensity/energy areset by the paricular procedure and the desired permanence.

32.

_153] Five ablation regions are illustrated 140, 141, 142, 143, and 144; however, there could be more or less regions.Ablation starts with area 144, then the probe is moved to 143 and so on to 140, conversely, ablations could start at 140 and progress to 144, Also, the practitioner could perform rotating, motions, thus further increasing the areas ofablation and permanence of the procedure, Between each ablation procedure 540 (FIG SC), a small nervestimulation test current 811 is emitted from electrode 301. Theapproximate effective range of the nerve stimulation current 811 is shown by 1204.Testing nerve response after each ablation allows the practitioner to immediately check level of nerve conduction Without probe 372 removal, the practitioner receives immediate feedback as to the quality of the ablation. Then minor probe position adjustments are madebefore conducting additionalablations (if required).

[01541 FIG 10 illustrates another example of system for use with the methods and procedures described herein. First the probe electrode 301 is positioned in the desired location relative to the target nerve 101 (FIG 10), then the userinitiates the treatment via switch(s) 410 and3110 using the selected power setting 404 (FGI0). The controller configures the generators 41.1. (FIG 10) and 412 to the amplitudefrequency and modulation envelope, delivering 50 KHz-2.5 MHz of 5 to 500 watts of available energy. The sunmning junction 413 combines the RF outputs as the application requires and passes them to the pulse-width modulator 415 fbr output power control, The output of modulation generator 420 isapplied to the muliplier 415 with radio frequency RF signals 422 and 423. This permits complex energy profiles to be delivered to a time variant non-linear biologic load. All of these settings are based on the information provide to the generatorby the installed probe 371 the selected power 404 settings, and the modulation envelope 420 (FIG 10) settings, which are then loaded by the generator 421,

[0155_ For example, both a high amplitude sine wave 910 (FIG. 15). used forcutting, and a pulse-width modulated (or PWM) sine wave 920, used for coagulation, are well known to electro-surgerv art. Precise power rates and limits of average total power are controlled via integrator 435 minimizing damage to nearby structures or buying close to the skin for shallow procedures. Where nearby structures 111 (FIG, 8) are too close to be avoided by electrodes suchas 371 (FIG 9A)and 372(FIG 9B), additionalprobe geometries as taught in herein offer additional methods to direct energyand limit ablation to a smaller region, thereby avoiding other structures. For safety a hardwired switch 436 disables the power amplifier in the event ofa system fault, the probe is unplugged or over power conditions protection both the patientand practitioner

[0156] The output of the modulator 415 is applied to the input of the power amplifier 416 section. The power amplifier's 416 outputsare then feed into theimpedance matching network 418, which provides dynamic controlled output to the biologic loads that are highly variable and non-linear, and require dynamic control of both power levels and impedance matching. The tuning of the matching network 418 is performed for optimal power transfer for the probe, power level, and treatment frequencies settled. The system's peak power is 500 watts for this disclosed embodiment Precise control is established by the proximity of the tip and the control loops included in the generator itself, The final energy envelope 420 is delivered to probe tip 301 and return electrodes 302,

[01571 Directed Ablation

[0158 In addition to thesubstantial radially-syrnmetric ablation patterns with probes as taught in 371 (FIG. 9A)and 372., switching or dividing ablation power tomultiple electrodes (FI,9D) can generate an asymmetric ablation zone. This high intensity source 608 with probe 610 (FIGS. 12A and 113) minimizes damage tonearby structures Illor the burning of skin 330 in shallow procedures. Also, FIGS. 813 and 9D identify probe confiurations for selective or asymmetric ablation.

[01591 Power Feedback

[01601 The power amplifier output 430 and buffered the feedback signals 437 can be connected to an Analog to Digital converter (or ADC) 431 for processor analysis and control Said signals 437 control power modulation 420 settings and impact the impedance matching control signals 419.This integrated power signal 437 is recorded to the operating-condition database (FIGI 16A) for later procedure review. This power level is also compared to reading taken from the probe 1492 (FIG. 1613) as compared against procedure maximums, which if exceeded will in tum disable the amplifier output, thereby protecting the patient from error or equipment fault. Similarly, limits from the probe and generator sensors such as temperature 330 can optionally be used to terminate or substantially reduce the modulated power levels and ultimately the procedure.

[01611 'he controllers described herein can also verify a selected procedure 1415 (FiG. 16A) for compatibility with installed probe. If incompatible, the user is also prompted to select a different power setting 404, procedure, or probe 371 If probe 371 matches power setting 404, the system enables powe amplifier 416, guide lught source 408,and low voltage nerve simulation 732.B oth oftheseprocedures are enforced byamandatory "hand shake" protocol and the serialized information, which must be present and properly verified by the electronic circuitry for a procedure to beinstituted. During a clinical procedure, information is required to be conveyed by the embedded electronics contained within the probe, which provides another way ofenforcing this protection and thus again preventing unauthorized re-use. The ultimate goal is prevent cross-contamination between patients The probe will accomplish this by being unique, serialized,and given theabove procedures. Once plugged in, the probe will enter the serial number into the data logging system via the serial bus 403 and circuit logic will thereafter prevent re-use of the probe and cross-contamination that would occur, Further, this scheme will prevent the use of unauthorized third party probes, for they will not be activated, preventing potential inferior or uncertified probes from being usedand presenting potential danger to the patient

[01621 Optical Probe Guidance

101631 Disclosed invention provides optical sources 408 that aid in probe placement (FIG. 17) by supplementing stinmulation source 732 and actingas preliminary guideProbe 771 is delectable between nerve stimulator or current 811 measurement and to or from the auxiliary probe tip 702, The ablation probe switch 367 selects low-energy stimulator/receiver or high-energy ablationto or from probe 371, 372, 373, and 374. In this mode, the physician operator wilHhave previously placed marks 755 on the surface of the skin by various means described. The physician operator 775 will then see the tip when the 448 if the optical illumination is turned on, 448 will providea bright spot under the skin indicating the location of the tip in relation to the marks 755. The physician 775 will then guide the probe tip 301 into precise alignment under these marks 755 so as to enable ablation of that target tissue 101. Alternative Probe Configurations

[01641 FIG. 19 is a schematic view of an alternative embodiment of a single axis electrosurgical probe 2000 havinga longitudinalprobeaxis 2001, which is similar to the probes described above. However, probe 2000 of FIG. 19 features substantially equal surface area conductive electrodes 2002 and 2004 located along a longitudinal axis. A probe 371 also having substantially equal surface area electrodes 301 and 302 is shown in above,

101651 In an equal electrodesurface area implementation, one of the conductive electrodes 2002 2004 may be selectivelyconnected to a stimulation current source or an ablation current source as described above. The other electrode 2002, 2004 may be unconnected or connected as a ground or return path for the connected current source, In the embodiment shown in FIG. 19 conductive electrode 2002 is coafigured to be conected to the ablation source making electrode 2002 the active electrode. Thus electrode 2004is in this embodimenta return electrode. Either electrode 2002, 2004 may be connected toa current source or return with appropriateswitches

101661 Sinceelectrodes 2002 and 2004 have substantially equal surface area, the local heating formed upon the application of RF ablation energy to the active electrode 2002 resultsinaheaing zone having a substantially symmetrical ellipsoid form.

[01671 The singleaxis electrosurgical probe 2000 of FIG. 19also featuresa dielectric insulator 2006 positioned along the probeaxis between the conductive electrodes 2002 and 2004. The dielectric insulator 2006mayhave any suitable length., and probes with alternative length insulators may be manufactured forspecific ablation procedures. Varying the length of the dielectric insulator 2006 varies the gap dimension 2008 between the electrodes 2002 and 2004. Varying the gap dimension 2008 provides for optimization of the current density within the ablation zone, varies thelength of theablation zone and permits the use of higher voltages, if desiredThus, the gap dimension may be selected in conjunction with other parameters such as electrode surface area and ablation current to achieveselect ablation volumes and. tissue temperatures for specific applications

[01681 The probe 2000 of FIG. 19 also features a blum tip 2010 rather than the conical tip 351, chiseled tip 352 or other tips of the probes described herein. The blunt tip 2010 of FIG.1 9 has a smooth rounded profile and is advantageous in certain instances to allow the probe to be easily advanced and maneuvered under the skin minimizing therisk of puncture or the cutting of adjacent tissue or anatomical structures, 'Thus, a blunt tip 2010 may significantly reduce the bruising or other trauma associated with a procedure.

[01691 The probe 2000 of FIG, 19 may include a sensor 2012, The sensorimay be a temperaturesensor 2012. A temperature sensor provides foractive temperature monitoring within the ablation zone. Alternatively, a single axis electrosurgical probe of any configuration may be implemented witha Kalman filter as taught by Conolly U.S, Pat. No. 6,384,384 which patent isincorporated herein by referenceinits entirely, Kalman filters are also used to esmatetissue temperature within an ablation volume, Kalman filters are suitableforuse where well-elnedissue statechangesoccuratspecifictemperaturesdue to protein denaturation such as the denaturation of collagen at 65C. Kalman filter temperature monitoring is advantageous because the bulk and cost of a separate temperature sensor can be avoided,

[01701 FIG. 20 isa schematic view ofanasymmetrical singleaxis probe204also defininga longitudinal probeaxis 2015,The probe 2014 features a first conductive electrode 2016 and a second conductive electrode 2018 having different surface areas, fn the embodiment shown in FIG. 20, the first electrode 2016 isanactive electrode and the second electrode 2018 having a larger surface area is a return electrode. A probe having any surface area ratio between an active and return electrode maybefabricated and used to achieve specific ablation results. Inaddition, the relative positions of the active electrode 2016 and the return electrode 2018 withrespect to the tip ofa given probe may be switched. i one embodiment the ratio oftheactive electrode 2016 to the surface area. of the return electrode 2018 is 1:3 .Other ratios including 1:8 may be implemented toachieve specific results. The surface area ratio may further be adjustable using a sleeve or other mechanism which will shield or cover a portion of on or both electrodes thus Increasing or decreasing the length of the gap defining dielectric insulator 2019, Generally, asymmetrical electrode surfaceareas will result in asymmetrical heating and ablation because of the higher current density of the RF ablation energy at the electrode with smaller surface area. For example, upon the application of RF energy to the active electrode of the FIG. 20 embodiment, a tissue volume proximal theactive electrode 2016 may be asymmetrically heated due to the greater current density resulting from the relatively small surface area of the active electrode 2016. Asymmetrical tissue heating coupled with precise RF power integration taught herein and various probe geometries permits the formation of selected repeatable and controlled ablation volumes.

101711 FIG. 21 schematically illustrates an alternative asyimnetrical probe 2020, which is similar in many respects to the asymmetrical probe 2014 of FIG. 20. The asymmetrical probe 2020 of FIG 21, however, features an active electrode 2022 having a surface area greater than that of the return electrode 2024. In the FIG, 21 embodiment current density is higher at the relatively smaller surface area electrode 2024., thus ablation energy is concentrated in the dielectric insulator gap 2025 between the electrodes 2022 and 2024 nearer return electrode 2024 and away from the tip of the probe.

10172] FIG, 22 is a schematic view of one embodiment of a multiple electrode probe 2026. The multiple eectrode probe2026 inchides a substantially needle-shaped probe body 2028 which defines a longitudinal probeaxis2029. More than two electrodes are associated with the probe body and positionedat various locations along the probe axis. In the FIG. 22 embodiment the electrodes include an active electrode 2030,a return electrode 2032 and a stimulation electrode 2034. In thisembodiment theactive electrode is positioned near the tip of the multiple electrode probe 2026,the return electrode 2032 is positioned away front the tip and the stimulation electrode 2034 is positioned between the active electrode 2030 and the return electrode 2032. It should be noted that the position of the various electrodes with respect to each other and. the tip maybe varied to achieve specific ablation and probe positioning advantages. In addition, the connection of any given physical electrode as an active electrode, return or stimulation electrode may be varied at the discretion of the user with a simple switching mechanism between the electrode and the ablation or stimulation energy sources. Alternatively, a separate ground or return path 2035 may be utilized with any configuration of electrodes. The various electrodes of the multiple electrode probe 2026 are separated by first dielectric insulator 2036 and asecond dielectric insulator 2038. FIG, 23 schematically illustrates the multi-polar probe 2026 of FIG, 22 withthe addition of a curved section2040 opposite the portion of the probe body 2028 associated with the electrodes, The curved section 2040.may in certain instances allow the practitioner toachieve optimal probe positioning witha minimtim of unnecessary tissue disruptionA multiple electrode probe 2026 maybe implemented with dielectric insulators 2036, 2038 of varing dimensions, sensors or electrodes of different surface areas, all as described above, to achieve desired ablation results.

{0173j FIG. 23-25 schematically illustrates an alternative embodiment of a nmiultiple electrode probe 2042, The multiple electrode probe 2042 of FIG. 23-25 includes a probe body 2044 which defines a longitudinal probe axis 2045. Multiple electrodes2046-2062 are associated with the probe body 2044 atseparate locations along the probe axis. In the embodiment shown in FIG. 23-25 the electrodes are uniformly sized and spaced. It is important to note, however, that different sizes ofelectrodesand non-uniform. spacing of the electrodes may be implemented to achieve specificablation results. Preferably, each of the electrodes 2046-2062 may be selectively connected with one or more switches to a stimulation current source, an ablation current source, a ground for the stimulation current source a ground for an ablation energy source or left unconnected, As described in detail below, the flexibIity provided by switched connection of each electrode toa current source or ground provides certain advantages in probe locationand ablation. Inaddition, the multiple electrode probe 2042 could be deployed in conjunction with a separate return electrode 2064, typically placed in contact with tissue away from the ablation site.

[01741 Placement Methods

[0175f Several methods of properly positioninga probe adjacent to a selected nerve for ablation energy application are discussed above. For exampleprobe placement methods featuring florescence marker dyes, optical probe guidance and electronic probe guidance with the use of low eney nerve stimulationcurrentarediscussed in detail, Certain of the alternative probe configurations as ilhistrated in FIGS. 19-25 provide for refined probe placement methods using variations of the basic electrical stiundation techniques described above,

[01761 The single axis electrosurgical probe 2000 of FIG. 18 or the asymmetric probes 2014, 2020 described herein can each be properly positioned using aniterative technique, as describedabove with reference to FIGS. 1IA-C.The iterative placement method may be refied for uses with multiple electrode probes such asare depictedin FIGS. 16-20.

101771 In probe embodiments where the stimulation electrode is positioned in between the ablation electrodes 2030.2032, the above described iterative method guarantees that the target nerve is positioned within an ellipticalablation zone 2064 (see FIG. 17) which will be formed between the active electrode 203( and return electrode 2032 upon the application of RF ablation energy.

[0178f FIG. 23-25 shows an alternative embodiment of a multiple electrode probe 2042 placed in various orientations with respect to a target nerve'2066. For example in FIG. 23, the multiple electrode probe 2042 is placed transverse the nerve 2066. in FIG, 24 the multiple electrode probe 2042 is placed parallel to a portion of thenerve 2066 and FIG. 25 shows the multiple electrode probe 2042 placed across the target nerve 2066 atan angle. As is described in detail above, each of the electrodes 2046-2065 may preferably be selectively connected to a stimulation current source, anablation energy source,a ground or left unconnected. The electrodes 2046-2062 may be connected manually or switched and activated electronically.

10179] The multiple electrodes of the FG.2325 embodiment of the multiple electrode probe 2042 provides otr certainadvanced placement and ablation procedures For example,FIG. 23 illustrates a method folocating and selectively applying energy to a target nerve 2066, which rns substantially transverse the probeat a point along the axial length of the probe 2042. This placement method features the practitioner initially positioning the probe across the targetnerve 2066, The electrodes 2046 through 2062 are then activated sequentially with stimulating current, in adjacent active/ground pairs (bipolar mode) or individually with reliance upon an external ground 2064 (mono-polar mode).The practitioner may then observe the response of one or moremuscles associated with the target nerve as stimulation current is applied to successive electrodes 2046-2062 f01801 For example, with reference to FIG 23, stinumlation current may beapplied between electrodes 2046 and. 2048. The practitioner notes that there is no corresponding muscle response. Stinulation current may next be appliedbetween electrodes 2048 and 2050, Again, no muscle response is observed by the practitioner. Sequentially, stimulation current is then applied to successive electrode pairs. When the stimulation current is applied between electrodes 2054and 2056 there may be a mildmuscle response. When the stimulation current is applied between electrodes 2056and 2058 however, a strong muscle response will be observed. Continuing on, thestimulation is then applied between electrodes 2058 and 2060. Hereareatl reducedmuscleresponse isobserved indicating that thenerve is crossing the probe substantially between electrodes 2056and 2058, Subsequentlyablation energy may be applied between designated electrodes 2056 and 2058 to ablate nerve 2066.

101811 FIG 24 illustrates a similar nerve location and ablation procedure herein the nerve 2066 is substantially parallel to and adjacent to the axial length of the probe 2042 adjacent electrodes 2048 through 2056, In this second example the practitioner first applies stimilation current is applied between electrodes 2046 and 2048. Amildmuscle response or no muscle response may be observed. When stimulation current is applied between electrodes 2048 and 2050, a strong muscle response is noted by the practitioner

[01821 Sequentially, the stimulation current is then applied between electrodes 2050 and 2052 with similar strong muscle response observed. This sequential stimulation and response process is observed through. the activation of electrodes 2056 and 2058 where the muscle response is substantially diminished or not observable, This is an indication that electrodes 2048 through2056 are all in contact with the nerve 2042. The electrodes 2048 through 2056 may then beswitched to the ablation current source activated and sequentially or simultaneously in bi-polar pairs or individually in bi-polar or mono-polar mode to ablate the nerve 2042,The nerve could be ablated along a select length defined by the number of electrodes activated by the practitioner. 'This method could also be implemented in mono-polar mode whereby stimulation orablation energy is applied between one or more electrodes 2046 through,2062 and a separate return electrode applied externally on the body.

101831 FIG. 25 illustrates a substantially similar nerve location andablation procedure wherein the multiple electrode probe 2042 crosses the nerve 2066 diagonally orat an oblique angle to the probe axis. Thus, FIG. 25 illustrates a method for angular positioning of the probe 2042 relative to the nerve 2066. In this example stimulation current applied as described above at electrodes 2052, 2054, and perhaps 2056 would result in a response in theassociated muscle. If larger number of electrodes elicit a muscleresponse, this is an indication of a broader nerve/probe contact area resulting from a more parallel contact placement of the probe 2042 relative to the nerve 2066. Such a determination of angular placement can be enhanced by fabricating a probe with relatively short distance between adjacent electrodes, relative to the diatneter of a nerve ofinterest. The practitioner may also maneuver the probe to attain a muscle response from more or less electrodes as desired providing the opportunity to ablate a greater or lesser length of the never withoutaxially repositioning the probe.

[01841 Theabove methods of angularpbepositioningand sequential stimulation may be combined with the iterative techniques also described above. For examplethe stimulation current generator may be set at a relatively high level initially and reduced when the general location of the nerve with respect to certain electrodesis determined,

101851 For example, the stimulation current threshold (to elicitan observable response) between electrodes 2048 and 2050 of FIG. 25 would behigher than the threshold between electrodes 2050 and 2053.This information could beindicated graphically, numerically oraudibly to allow the practitioner to reposition the probe for more parallel or more transverse positioning of probe 2042 relative to nerve 2066,

101861 The apparatus and methods described abovenay be implented with various features which enhance the safety,ease of use and effectiveness of the system. For example, the probe may be implemented with an ergonomic and functional handle which enhances both operational effectiveness and provides for the implementation of safety features. Individual probes may be carefully managed, preferably with system software to assure that aselected probe functions properly, is sterile and not reused, and that the proper probe is used for each specific treairnent procedure Similarly, safeguards may beincluded with the system toassure that the operator is certified and trained for the specific treatment protocol selected. Various treatment management methods and specific treatment therapies may be selected for both the best results and forenhanced patient safety. In one embodiment, the treatment, therapeutic, and safety methods may be implemented with and rigorously controlled by software running on a processor associated with the ablation apparatus and system as is described in detail below.

f01871 System Management Method

[01881 The concurrent goals of patientsafety, procedure efficiency and therapeutic success can be advanced through an effective system managementmethod. A system management method such as is described herein may beimplemented through computer software and hardware including computer processors and memory operating within or in association with the control consoleand the probe system described herein. Various interfaces between a practitioner, the control console, and the probe system may be present. In addition the hardware associated with an ablation system, including the probe stimulation current source,ablation currentsource, and the probe system may be in communication with and provide feedback to the system processor- Alternatively, the steps of the system management method could be implemented manually.

[01891 In a softwareand processor based system embodiment, the techniques described below for managing an electrosurgical probe and systemimay be implemented as a method, apparatus or article ofmanufacture using standard programming and/orenieerin techniques to produce software, firmware, hardware, orany combination thereof. The term "article of manufacture" as used herein refers to code or logic implemented with or stored upon a medium or device ., magnetic storageimedium such as hard disk drives, flopy disks, tape), optical storage (e.g., CD-ROMs, optical disks, etc-), volatile and non-volatile memory devices (e~gEEPROMs ROMs, PROMs, RAMs DRAMs, SRAMs, firmware, programmable logic, etc.). Code inthe computer readable medium isaccessed and executed by a processor. The code in which implementations are made may further be accessible through a transmission media or from a file server overa network. In such cases, the article of manufacture in which the code is implemented may comprise a transission media such as network transmission line, wireless transmission media, signals propagating through space, radio waves, infrared, optical signals, etc. Of course, those skilled in the art will recognize that many modifications may be made to this configuration without departingfrom the scope of the implementations and that the article of manulfacture may comprise any information bearing medium known in the art.

[0190} Therapeutic'TreatmentProtocols

[01911 As disclosed herein tissue ablation or a nerve block or other minimally invasive electrosargical procedure may be performed with precisely applied RF energy A fundamental requirement of the therapeutic RF waveform is to heat and denature human tissue in a small area over a selected timeframe, for example, less than 25 seconds Laboratory experiments indicate this to bea suitable time required to adequately ablate a small motornerve.Lonerorshorter treatment times may be required for other applications. The temperature required to denature thefine structure of the selected tissue, primarily proteins and lipids is approximately 65.degree. C. and above.

[01921 To safely achieve appropriate ablation,nerve block or other treatmentgoals, the RF waveform may be generatedandapplied to meet the following criteria: LTheprobe temperature will be limited to less than I60.degree. C. in order to prevent excess damage to collateral tissue areas. 2.The probe temperatures will preferably be held to between 90.degree. and 105degree. C. This range will prevent excessive tissue sticking as wellas aid in the growth of an appropriate ablation lesion.

[01931 Ilitial RF power application should bring the temperature of the probe tip to a working therapeutic temperature in controlled manner, causing minimal overshoot. The time frame for the initial warming phasemay be between 0.2 to 2.5 seconds.

101941 To achieve the foregoing generalized goals, specific treatment protocols may be developed. In one embodiment of the present invention, the delivery of a specific therapeutic protocol (also described as an "energy bolus") herein is automated. Automation can increasesafety and treatment effectiveness since the practitioner may concentrate on probe placement While the system assures the delivery of the selected energy bolus. For example, the system controller 401 may be configured to control the waveform of energy supplied toan electrosurgical probe connected to the system, In particular, the wave shape, waveform modulation or pulse time may be controlled. Also, the total time during which power may beapplied and maximum power or voltage limits may be set. In addition, a specific treatment protocol may be actively controlled according to feedback such as the probe temperature, adjacent tissue temperature, tissue impedance or other physical parameters which may bemeasured during (he delivery of treatment energy. Specific energy delivery prescriptions or energy bohises may be developed for specific treatment goals. These energy prescriptions may be stored inm emory associated with the controller as a permitted therapeutic protocol A representative therapeutic energy protocol 3250 is shown in tabular form on FIG. 26.

[0195j The therapeutic protocol 3250 of FI6 27 is optimizedfor the therapeutic ablation of a human nerve having a diameter of approximately I millimeter, As shown on FIG. 27, the treatment protocol 3250 is generally designed to rapidly heat tissue during an initial phase 3252. Rapid heating during the initial phase has been shown tomnimMize perceived pain and reduce muscle stimulation from the subsequent application of pulsed RF energy. A second phase 3254 includes constant powerapplicationresuhin ain slower ramp to a desired therapeutic tissue;probe temperature, As also shown on FIG. 27. a third phase 3256 includes the maintenanceof a constant temperature at reduced power to row theablation lesion to a desired size.

101961 The therapeutic treatment protocol 3250 illustrated on FIGS, 26 and 27 is only one treatment protocol which has been found suitable for the ablation of a small motor nerve Other treatment protocols may be developed for other or thesame therapeutic goals. In all cases, the level of tissueablation is substantially exponentially related to the product of timeand temperature above 40.degree. C. as is well known in the art as the Arrhenius rate. Thermal heat transport through target tissue may be calculated witha finite difference algorithm. Tissue properties may be specified on a 2D mesh and such properties can be arbitrary functions of space and time. Arrhenius rate equations may be solved for the extent of ablation caused by elevated temperatures. In addition, opticaland electrical properties which are characteristic of ablated tissuemay bemeasured and determinedthrough histological studies. Thus. various therapeutic protocols such as that illustrated in FIGS. 26 and27 may be developed and optimized for the controlled achievement of desired therapeutic results. Preferably the therapeutic protocolsare automatically delivered to assure that the selected energy bolus is precisely delivered.

101971 The devices and systems described below are provided as examples of details of constructionandarrangementof components.The invention includes variations of devices, systems and methods thatcapable of other embodiments and of beingpracticedorofbeing carried out in various ways. Also, the phraseology and terminology used herein is for the purpose of description and should not be regarded aslimiting. The use of"including," comprising "having. "contaiing"involving" and variations thereof herein is meant to encompass the items listed thereafterand equivalents thereof as well as additional items.

Claims (20)

1. A method of treating a nerve in a tissue region, the method comprising: positioning a working end of a device into the tissue region, where the device includes an energy delivery mode and a stimulation mode, where the stimulation mode comprises at least a first parameter setting that stimulates the nerve within a first distance from the working end, and a second parameter setting that stimulates the nerve within a second distance from the working end; stimulating the nerve at the first parameter setting; repositioning the working end of the device in the tissue region to move the working end closer to the nerve; activating the device in the stimulation mode at the second parameter setting to observe stimulation of the nerve and confirm positioning of the working end of the device closer to the nerve; and activating the device in the energy delivery mode to create a first treatment location on the nerve; repositioning the working end of the device on a distal section of the nerve between a muscle controlled by the nerve and the first treatment location; and activating the device in the energy delivery mode to create a second treatment location on the nerve.

2. The method of claim 1, where the first distance is greater than the second distance, and where the device is configured to prevent activation of the energy delivery mode when the stimulation mode is in the first parameter setting.

3. The method of claim 2, where activating the device in the energy delivery mode causes the device to reset to the first parameter setting.

4. The method of claim 1, where positioning the working end of the device and repositioning the working end of the device occurs without removing the device from a puncture site.

5. The method of claim 1, further comprising injecting an anesthetic at or near the first treatment location prior to activating the device in the energy delivery mode.

6. The method of claim 1, further comprising the use of an external nerve stimulator to create a map of the nerve anatomy on an external surface of the tissue region, prior to inserting the device, and using the map as a guide to identify at least one target treatment location.

7. The method of claim 1, where energy delivery mode comprises at least one pre determined treatment setting.

8. The method of claim 1, where the device includes a controller configured to power the device between the stimulation mode and the energy delivery mode.

9. The method of claim 1, where the device is capable of being manually overridden to the energy delivery mode w the stimulation mode is in the first parameter setting.

10. A method of treating a nerve in a tissue region, the method comprising: positioning a working end of a device into the tissue region at a first location the device is configured to apply stimulation energy and to apply therapeutic energy; wherein when supplying stimulation energy the device is settable in one of a plurality of settings, the plurality of settings comprising at least a first setting and a second setting, where a stimulation area of the device is larger when the device is operated at the first setting, and where the device is configured to prevent application of the therapeutic energy when the device is in the first setting; operating the device at the second setting to apply stimulation energy; observing a response in the tissue region for stimulation of the nerve; after observing the response in the tissue region, applying therapeutic energy to at least a portion of the nerve at the first location to prevent the nerve from transmitting a neural signal, wherein after applying, therapeutic energy the device switches to the first setting, and is prevented from applying the therapeutic energy; repositioning the working end of the device at a subsequent location distal to the first location; adjusting the device to the second setting from the first setting; operating the device at the second setting to apply stimulation energy at the subsequent location; observing a subsequent response in the tissue region caused by stimulation of the nerve at the subsequent location; and after observing the subsequent response, applying therapeutic energy to at least a second portion of the nerve at the subsequent location.

11. The method of claim 10, where repositioning the working end of the device at the subsequent location comprises moving the device in a direction relative to the nerve to create multiple treatment locations along the nerve.

12. The method of claim 11, where moving the working end of the device in the direction relative to the nerve comprises moving the working end of the device in a forward direction distally to the first location along the nerve such that a muscle associated with the nerve can be stimulated during stimulation of the nerve.

13. The method of claim 10, where repositioning the working end of the device at the subsequent location occurs without removing the working end of the device from the tissue region.

14. The method of claim 10, where repositioning the working end of the device further comprises moving the working device in a plurality of directions without removing the working end of the device from the tissue region.

15. The method of claim 10, further comprising injecting an aesthetic at or near the tissue region at the first location prior to applying energy to the tissue region.

16. The method of claim 10, further comprising reducing, a temperature of a surface of the tissue region above a treatment zone prior to applying therapeutic energy.

17. The method of claim 10, further comprising using an external nerve stimulator to map the nerve anatomy in the tissue region prior to inserting the working end of the device into the tissue region and using the map to identify target treatment locations.

18. The method of claim 10, where the first setting comprises a first current setting and the second setting comprises a second current setting, where the second current setting is less than the first current setting.

19. The method of claim 10, where the first setting is fixed.

20. The method of claim 10, where observing the response in the tissue region for stimulation of the nerve comprises: observing for movement of tissue at a surface of the tissue region; or performing electromyography on at least one muscle associated with the nerve; or measuring an electrical impulse in at least one muscle associated with the nerve using a measuring electrode.