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`
`US 20140046423Al
`
`c19) United States
`c12) Patent Application Publication
`RAJGURU et al.
`
`c10) Pub. No.: US 2014/0046423 Al
`Feb. 13, 2014
`(43) Pub. Date:
`
`(54) METHOD AND APPARATUS FOR
`TRANSDERMAL STIMULATION OVER THE
`PALMARAND PLANTAR SURFACES
`
`(60) Provisional application No. 61/403,680, filed on Sep.
`20, 2010, provisional application No. 60/848,720,
`filed on Oct. 2, 2006.
`
`(71) Applicant: EMkinetics, Inc., San Francisco, CA
`(US)
`
`(72)
`
`Inventors: Amit RAJGURU, Lafayette, CA (US);
`Daniel R. BURNETT, San Francisco,
`CA (US)
`
`(73) Assignee: EMkinetics, Inc., San Francisco, CA
`(US)
`
`(21) Appl. No.: 13/840,936
`
`(22) Filed:
`
`Mar. 15, 2013
`
`Related U.S. Application Data
`
`(63) Continuation-in-part ofapplication No. PCT/US2011/
`052415, filed on Sep. 20, 2011, Continuation-in-part
`of application No. 12/508,529, filed on Jul. 23, 2009,
`which is a continuation-in-part of application No.
`11/866,329, filed on Oct. 2, 2007.
`
`Publication Classification
`
`(51)
`
`Int. Cl.
`A61N 1104
`(52) U.S. Cl.
`CPC .................................... A61N 110456 (2013.01)
`USPC ........................................... 607/144;607/115
`
`(2006.01)
`
`ABSTRACT
`(57)
`Various methods and devices for providing transdermal elec(cid:173)
`trical stimulation therapy to a patient are provided. In certain
`variations, a method may include positioning a stimulator
`electrode over a glabrous skin surface overlying a target nerve
`of a subject. Electrical stimulation may be delivered through
`or across the glabrous skin surface to the target nerve to
`stimulate the target nerve, while remaining safe and tolerable
`to the patient. Electrical stimulation may be delivered at fre(cid:173)
`quencies that may be painful or intolerable when applied over
`non-glabrous surfaces of the body. Various applicators or
`devices for providing transdermal electrical stimulation
`therapy are also provided.
`
`32
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`1
`
`METHOD AND APPARATUS FOR
`TRANSDERMAL STIMULATION OVER THE
`PALMARAND PLANTAR SURFACES
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`[0001] This application is a continuation in part of PCT
`International Patent Application Number PCT/US2011/
`052415, filed Sep. 20, 2011, which claims benefit of priority
`to U.S. Provisional Patent Application Ser. No. 61/403,680
`filed Sep. 20, 2010. The present application is also a continu(cid:173)
`ation-in part of U.S. patent application Ser. No. 12/508,529
`filed Jul. 23, 2009, which is a continuation-in-part of U.S.
`patent application Ser. No. 11/866,329 filed Oct. 2, 2007,
`which claims priority to U.S. Provisional Patent Application
`Ser. No. 60/848,720 filed Oct. 2, 2006. Each of the above
`referenced applications is incorporated herein by reference in
`their entirety.
`[0002] The following applications are also incorporated
`herein by reference in their entirety for all purposes: PCT
`Application Serial No. PCT/USl0/54167 filed Oct. 26, 2010;
`PCT Application Serial No. PCT /US 10/054,353 filed Oct. 27,
`2010; U.S. patent application Ser. No. 12/508,529 filed Jul.
`23, 2009, which is a continuation in part of U.S. patent appli(cid:173)
`cation Ser. No. 11/866,329 filed Oct. 2, 2007, which claims
`priority to U.S. Provisional Patent Application Ser. No.
`60/848,720 filed Oct. 2, 2006; U.S. patent application Ser.
`No. 12/695,087 filed Jan. 27, 2010, which is a continuation of
`U.S. patent application Ser. No. 11/332,797 filed Jan. 17,
`2006; U.S. patent application Ser. No. 12/509,362 filed Jul.
`24, 2009; Ser. No. 12/469,365 filed May 20, 2009 which is a
`continuation of U.S. patent application Ser. No. 11/866,329
`filed Oct. 2, 2007 which claims priority to U.S. Provisional
`Patent Application Ser. No. 60/848, 720 filed Oct. 2, 2006, and
`Ser. No. 12/469,625 filed May 20, 2009 which is a continu(cid:173)
`ation ofU.S. patent application Ser. No. 11/866,329 filed Oct.
`2, 2007 which claims priority to U.S. Provisional Patent
`Application Ser. No. 60/848,720 filed Oct. 2, 2006; and Ser.
`No. 12/509,304 filed Jul. 24, 2009 which is a continuation of
`U.S. patent application Ser. No. 12/508,529 filed Jul. 23, 2009
`which is a continuation-in-part ofU.S. patent application Ser.
`No. 11/866,329 filed Oct. 2, 2007 which claims priority to
`U.S. Provisional Patent Application Ser. No. 60/848,720 filed
`Oct. 2, 2006; and Ser. No. 12/509,345 filed Jul. 24, 2009
`which is a continuation of U.S. patent application Ser. No.
`12/508,529 filed Jul. 23, 2009 which is a continuation-in-part
`of U.S. patent application Ser. No. 11/866,329 filed Oct. 2,
`2007 which claims priority to U.S. Provisional Patent Appli(cid:173)
`cation Ser. No. 60/848,720 filed Oct. 2, 2006.
`
`FIELD OF THE INVENTION
`
`[0003] The present apparatus and methods relate generally
`to energy emitting apparatus and methods for providing a
`medical therapy. The apparatus and methods may provide for
`central and peripheral nerve and other tissue modulation or
`stimulation therapies
`
`BACKGROUND
`
`[0004] The OAB and UI market in the United States is well
`over a $12 billion a year industry. It affects over 16% of all
`Americans, for a total U.S. market of approximately 34 mil(cid:173)
`lion men and women each year. Due to social stigmas
`attached to OAB and UI, as well as misunderstanding of the
`
`signs and symptoms associated with OAB and UI, only 40%
`of those affected (13.6M) seek treatment. Of those 13.6 mil(cid:173)
`lion individuals, nearly 30% are unsatisfied with their current
`therapy.
`[0005] The use of pulsed electromagnetic stimulation
`(PES) has been well established as a beneficial therapy in a
`variety of medical applications. The scientific principle
`behind this technology is that an electric current passed
`through a coil will generate an electromagnetic field. These
`fields, in turn, have been shown to induce current within
`conductive materials placed within the field. When applied to
`the human body, pulsed electromagnetic stimulation has been
`found to be an effective method of stimulating nerves resting
`within the electromagnetic field. Recent data highlights the
`beneficial effects of invasive, needle-based electrostimula(cid:173)
`tion (ES) of the posterior tibial nerve in individuals with OAB
`and UI. ES has been found to modulate bladder dysfunction
`through its action on the pudenda! nerve and the sacral plexus
`which provides the major excitatory input to the bladder.
`[0006] Current treatment options for OAB and UI are exer(cid:173)
`cise and behavioral modifications, pharmacological thera(cid:173)
`pies, surgical intervention, and neuromodulation. Although
`each of these treatment options targets the UI and OAB popu(cid:173)
`lations, each has severe limitations.
`[0007] Exercise and behavioral modifications often require
`patients to adhere to stringent routines, including scheduled
`voiding, maintenance of a bladder diary, and intense exercise
`regiments. While this may be a viable option for a small group
`of highly dedicated individuals, its daily impact on one's life
`makes it an unattractive option for most individuals.
`[0008] Pharmacological intervention is the most widely
`prescribed therapy for OAB and UI. Unfortunately, as with
`the ingestion of any chemical, patients are often subject to
`side effects from their drug therapy. This is especially detri(cid:173)
`mental in older and elderly patient populations where inter(cid:173)
`action with other prescribed medications can have adverse
`effects. Further, there is a high rate of dissatisfaction, approxi(cid:173)
`mately 30%, amongst individuals using pharmacological
`treatment.
`[0009] Surgical intervention is an extremely invasive treat(cid:173)
`ment and often results in the long-term, and in some cases
`permanent, requirement for catheterization. The high
`expense of these procedures, coupled with the negative
`impact the procedures have on the patients quality of life,
`make this an option only when all other treatment options
`have been exhausted.
`[0010] Neuromodulation is another treatment alternative
`for OAB and UI patients. Sacral nerve stimulation (SNS) has
`shown itself to be an effective treatment option for those with
`OAB or UI. However, the procedure requires the permanent
`implantation of an electrical stimulation device in the patient.
`One estimate puts the cost at nearly $14,000 with additional
`routine care costs of $593 per patient per year. Additionally,
`SNS' s risk of battery failure, implant infection, and electrode
`migration, lead to a high reoperation rate and make this pro(cid:173)
`cedure unattractive.
`[0011] More recently, the introduction of a posterior tibial
`nerve stimulator, often referred to as SANS, has shown itself
`to be another neuromodulation alternative. Yet as is the case
`with other forms of neuromodulation, this system is invasive
`in its nature. It requires the insertion of a needle two inches
`into the patient's ankle region in order to stimulate the pos(cid:173)
`terior tibial nerve. As well, it requires a minimum of 12
`sessions for initial treatment, with the possibility of additional
`
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`2
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`sessions needed for maintenance. Despite its high cost and
`invasive nature, though, an abundance of published peer(cid:173)
`reviewed clinical trials demonstrate the safety and efficacy of
`the SANS therapy.
`
`SUMMARY
`
`[0012]
`In certain variations, a method for providing trans(cid:173)
`dermal electrical stimulation therapy to a patient is provided.
`The method may include positioning a stimulator electrode
`over a glabrous skin surface overlying a target nerve of a
`subject. Electrical stimulation may be delivered through or
`across the glabrous skin surface to the target nerve to stimu(cid:173)
`late the target nerve, while remaining safe and tolerable to the
`patient. Electrical stimulation may be delivered at frequen(cid:173)
`cies that may be painful or intolerable when applied over
`non-glabrous surfaces of the body. The electrical stimulation
`may be utilized to treat various conditions, e.g., urinary
`incontinence and overactive bladder.
`[0013]
`In certain variations, an applicator, e.g., an ergo(cid:173)
`nomic applicator, for providing transdermal electrical stimu(cid:173)
`lation therapy to a patient is provided. The applicator may be
`configured to position a stimulator electrode over a glabrous
`skin surface of the subject to deliver transdermal electrical
`stimulation through or across the glabrous skin surface to an
`underlying target nerve, resulting in stimulation of the target
`nerve.
`[0014]
`In certain variations, a method for providing an
`energy based stimulation therapy to a subject is provided. The
`method may include positioning an energy emitting device in
`proximity to a glabrous surface overlying a target tissue.
`Energy may be delivered through the glabrous skin surface to
`the target tissue to stimulate the target tissue.
`[0015]
`In certain variations, another method for providing
`an energy based stimulation therapy to a subject is proved.
`The method may include positioning an energy emitting
`device in proximity to a skin surface overlying a target nerve.
`Energy may be delivered at a frequency of about 1 Hz to about
`30 Hz through the skin surface to the target nerve, thereby
`generating motor and/or sensory nerve conduction of the
`target nerve while remaining safe and tolerable to the subject.
`Optionally, energy may be delivered at less than 10 Hz to
`generate nerve conduction.
`[0016]
`In certain variations, systems for electromagnetic
`induction therapy may include one or more conductive coils
`disposed within or along an applicator. The coils may be
`configured to generate a magnetic field focused on a target
`nerve, muscle or other body tissues in proximity to the coil.
`One or more sensors may be utilized to detect electrical
`conduction in the target nerve, to detect a muscular response
`caused by an electrical conduction in the target nerve, or to
`detect stimulation of a nerve, muscle or other body tissues and
`to provide feedback about the efficacy of the applied electro(cid:173)
`magnetic induction therapy. A controller in communication
`with the sensor may be adjustable to vary a current through
`the at least one coil so as to adjust the magnetic field focused
`upon the target nerve, muscle or other body tissues. Option(cid:173)
`ally, a user or patient may detect stimulation of a nerve,
`muscle or body tissue and the therapy may be adjusted based
`on feedback from the user or patient.
`[0017]
`In certain variations, the applicator may be config(cid:173)
`ured to intermittently apply or deliver pulsed magnetic fields
`to a target nerve, muscle or tissue without causing habituation
`of the target nerve, muscle or tissue.
`
`[0018]
`In certain variations, methods of electromagnetic
`induction therapy may include one or more of the following
`steps. A first portion of a patient's body may be positioned
`relative to or in proximity to an applicator or an applicator
`may be positioned relative to or in proximity to a first portion
`of a patient's body, such that a target nerve, muscle or tissue
`within the first portion of the body is in proximity to one or
`more conductive coils disposed within or along the applica(cid:173)
`tor. A current may be passed through a coil to generate a
`magnetic field focused on the target nerve, muscle or tissue.
`An electrical conduction through the target nerve, a muscular
`response caused by an electrical conduction through the tar(cid:173)
`get nerve or stimulation of a nerve, muscle, or body tissue
`may be detected by a sensor positioned along a second portion
`of the body. A signal from the sensor indicative of the elec(cid:173)
`trical conduction or stimulation may be received, which pro(cid:173)
`vides feedback about the efficacy of the applied electromag(cid:173)
`netic induction therapy. The current may be adjusted by a
`controller in communication with the conductive coils based
`on the feedback.
`[0019] Optionally, a user may detect stimulation of a nerve,
`muscle or body tissue and the therapy may be adjusted based
`on feedback from the user. In certain variations, pulsed mag(cid:173)
`netic fields may be intermittently applied or delivered a target
`nerve, muscle or tissue without causing habituation of the
`target nerve, muscle or tissue. Such intermittent magnetic
`fields may be used to treat chronic conditions, e.g., chronic
`pain, without causing habituation.
`[0020]
`In certain variations, applicators may be ergonomic
`or may be designed or configured to accommodate, approxi(cid:173)
`mate or be positioned relative to or in proximity to specific
`regions of the body or anatomy. The specific regions of the
`body or anatomy may be positioned relative to the applica(cid:173)
`tors, or the applicators may be positioned relative to the
`specific regions of the body or anatomy to treat various con(cid:173)
`ditions, for example, osteoarthritis, arthritis, back or neck
`pain, atrophy or paralysis, chronic pain, phantom or neuro(cid:173)
`pathic pain, neuralgia, migraines, orthopedic conditions.
`[0021] Other features and advantages will appear hereinaf(cid:173)
`ter. The features and elements described herein can be used
`separately or together, or in various combinations of one or
`more of them.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0022] The drawings constitute a part of this specification
`and include exemplary embodiments of the invention, which
`may be embodied in various forms. It is to be understood that
`in some instances various aspects of the embodiments may be
`shown exaggerated or enlarged to facilitate an understanding
`of the embodiments.
`[0023] FIG. 1 is a schematic view of an apparatus for mag(cid:173)
`netic induction therapy according to a first variation.
`[0024] FIG. 2 is a schematic view of an apparatus for mag(cid:173)
`netic induction therapy according to a second variation.
`[0025] FIG. 3 is a schematic view of an apparatus for mag(cid:173)
`netic induction therapy according to a third variation.
`[0026] FIG. 4 is a schematic view of an apparatus for mag(cid:173)
`netic induction therapy according to a fourth variation.
`[0027] FIG. 5 is a schematic view of an apparatus for mag(cid:173)
`netic induction therapy according to a fifth variation.
`[0028] FIGS. 6A-6D are schematic illustrations depicting a
`first method of use of an apparatus for magnetic induction
`
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`therapy. This method is based on adjusting the position of the
`conductive coils so to optimize a magnetic flow applied to a
`target nerve.
`[0029] FIGS. 7 A-7D are schematic illustrations of a second
`method of use of an apparatus for magnetic induction therapy.
`This method is based on locking the conductive coils in
`position once electrical conduction in a target nerve has been
`detected.
`[0030] FIG. 8 is a schematic view of a variation that
`includes a plurality of sensors.
`[0031] FIGS. 9A-9D are schematic representations of dif(cid:173)
`ferent garments adapted to operate as apparatus for magnetic
`induction therapy.
`[0032] FIG. 10 is a schematic view of an apparatus for
`providing electrical stimulation.
`[0033] FIG. 11 is a schematic view of another variation of
`an apparatus for providing electrical stimulation.
`[0034] FIG. 12 shows a schematic view of an energy emit(cid:173)
`ting system including a microneedle patch sensor.
`[0035] FIG.13-15 shows magnified bottom views of varia(cid:173)
`tions of microneedle patches.
`[0036] FIGS. 16-17 shows magnified side views of varia(cid:173)
`tions of a microneedle patch.
`[0037] FIG. 18 shows a magnified bottom perspective view
`of a microneedle patch.
`[0038] FIG. 19 shows a representative cross sectional view
`of the skin composed of an outer stratum comeum covering
`the epidermal and dermal layers of skin and the underlying
`subcutaneous tissue, with a variation of a microneedle patch
`attached thereto.
`[0039] FIG. 20a shows a magnified side view of a variation
`of a microneedle patch including multiple electrodes.
`[0040] FIG. 20b-20D show variations of a microneedle
`patches including multiple electrodes.
`[0041] FIG. 21 shows a schematic view of an energy emit(cid:173)
`ting system including a microneedle patch sensor placed
`behind a subject's knee.
`[0042] FIGS. 22-23 show schematic views of energy emit(cid:173)
`ting systems including an electrode needle and sensor.
`[0043] FIGS. 24-25 show schematic views of energy emit(cid:173)
`ting systems including an electrode needle without a sensor.
`[0044] FIG. 26 shows a schematic view of an energy emit(cid:173)
`ting system including a microneedle patch for providing
`stimulation.
`[0045] FIGS. 27-28 show schematic views of energy emit(cid:173)
`ting systems including an electrode needle and microneedle
`patch for providing stimulation.
`[0046] FIG. 29a-29d show a prospective, side, top and rear
`views of an energy emitting device in the form of a foot
`cradle.
`[0047] FIGS. 30a-30b show schematic views of an energy
`emitting device in the form of a knee support.
`[0048] FIGS. 3la-3lb shows a schematic view of a varia(cid:173)
`tion of an arm applicator and a foot, knee or leg applicator.
`[0049] FIG. 32 shows a schematic view of a variation of a
`back applicator.
`[0050] FIG. 33 shows a schematic view of a variation of a
`system including a back applicator, a sensor and logic con(cid:173)
`troller.
`[0051] FIG. 34 shows a schematic view of system including
`multiple back applicators, a sensor and logic controller.
`
`[0052] FIG. 35 shows a schematic view of a variation of a
`system including a back applicator held on a patient's body by
`an ergonomic positioning element in the form of a belt and a
`logic controller.
`[0053] FIG. 36 shows a schematic view of a variation of an
`applicator designed to stimulate a nerve responsible for phan(cid:173)
`tom or neuropathic pain.
`[0054] FIG. 37 shows a schematic view of a variation of a
`facial neuralgia applicator.
`[0055] FIG. 38 shows a schematic view of a variation of an
`applicator which may be placed over the occipital nerve for
`the treatment of migraines.
`[0056] FIG. 39 shows a schematic view of a variation of an
`applicator which may be placed over the frontal cortex for the
`treatment of depression.
`[0057] FIG. 40 shows a schematic view of a variation an
`applicator in the form of a stimulator coil platform for posi(cid:173)
`tioning one or more coils in proximity to a knee or popliteal
`nerve.
`[0058] FIG. 41 shows a schematic view of a system includ(cid:173)
`ing a variation of a back applicator held on a patient's body by
`an ergonomic positioning element in the form of a shoulder
`harness, a sensor, and a logic controller.
`[0059] FIGS. 42A and 42B show an example of how the
`amount of stimulator power required to achieve a desired
`stimulus may be automatically adjusted as a result of fibroses.
`[0060] FIGS. 43A and 43B show variations of a coil device
`positioned on a sknll.
`[0061] FIG. 44 shows a view of the underside or glabrous
`surface of the foot and exemplary sites for delivering electri(cid:173)
`cal stimulation.
`[0062] FIG. 45 shows a perspective view of one variation of
`an insole for delivering electrical stimulation over a glabrous
`surface of the foot.
`[0063] FIG. 46 shows a perspective view ofa variation of an
`insole for delivering electrical stimulation over a glabrous
`surface of the foot, including a sensor feedback feature.
`[0064] FIG. 47 shows a perspective view of one variation of
`electrodes for delivering electrical stimulation over a gla(cid:173)
`brous surface of a foot.
`[0065] FIG. 48 shows a perspective view of one variation of
`a hand applicator for delivering electrical stimulation over a
`glabrous surface of a hand.
`[0066] FIG. 49 shows a perspective view of one variation of
`electrodes for delivering electrical stimulation over a gla(cid:173)
`brous surface of a hand.
`[0067] FIG. 50 shows an example of an EMG reading.
`
`DETAILED DESCRIPTION
`
`[0068]
`In certain variations, various apparatus and methods
`for providing magnetic induction therapy or electrical stimu(cid:173)
`lation therapy are provided. In certain variations, various
`apparatus and methods may provide for central and periph(cid:173)
`eral nerve and other tissue modulation or stimulation thera(cid:173)
`pies, including both excitation and blocking of nerve
`impulses. In certain variations, a low frequency induction
`therapy may be performed. In certain variations, these appa(cid:173)
`ratus and methods may be useful in the treatment and preven(cid:173)
`tion of urinary incontinence (UI), overactive bladder (OAB)
`and other conditions.
`[0069]
`In certain variations, apparatus and methods for
`magnetic induction therapy, in which dosage of magnetic
`energy can be regulated according to conduction in a target
`nerve exposed to the magnetic field are provided.
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`[0070]
`In certain variations, apparatus and methods for
`magnetic induction therapy, in which the flow of magnetic
`energy can be adjusted directionally by the patient or a health(cid:173)
`care provider without altering the position of a housing con(cid:173)
`taining conductive coils that produce the magnetic field are
`provided.
`[0071]
`In certain variations, apparatus and methods for
`treating a variety of ailments by providing energy to a target
`nerve, for example magnetic energy, electrical energy or
`ultrasound energy, at a location and in an amount optimized
`by detecting conduction in the target nerve are provided.
`[0072]
`In certain variations, an energy emitting apparatus
`for delivering a medical therapy that includes one or more
`energy generators, a logic controller electrically connected to
`the one or more energy generators, and one or more sensors
`for detecting electric conduction in a target nerve, which are
`connected to the logic controller is provided. The one or more
`energy generators produce energy focused on the target nerve
`upon receiving a signal from the logic controller, and the
`applied energy is varied by the logic controller according to
`an input provided by the one or more sensors based on electric
`conduction in the target nerve. The feedback provided by the
`sensors to the logic controller about the efficacy of the applied
`treatment causes the logic controller to modulate the current
`transmitted to the coils.
`[0073] The applied energy may be a magnetic field, an
`electrical field, an ultrasound, a visible light, or an infrared or
`an ultraviolet energy. When a magnetic field is applied, the
`energy-emitting device is an apparatus that provides a mag(cid:173)
`netic induction therapy and that includes one or more con(cid:173)
`ductive coils disposed in an ergonomic housing. A logic con(cid:173)
`troller is electrically connected to the one or more coils, and
`one or more sensors detect electric conduction in the target
`nerve and are connected to the logic controller so to provide
`a feedback to the logic controller. The conductive coils
`receive an electric current from the logic controller and pro(cid:173)
`duce a magnetic field focused on a target nerve, and the
`electric current fed by the logic controller is varied by the
`logic controller according to an input provided by the sensors,
`thereby causing amplitude, frequency or direction of the mag(cid:173)
`netic field, or the firing sequence of the one or more coils, to
`be varied according to the efficiency of the treatment provided
`to the target nerve. In certain variations, the housing contain(cid:173)
`ing the conductive coils may be a flexible wrap, a cradle or a
`garment, and the coils may be overlapping and/or be disposed
`in different positions within the housing, so to generate a
`magnetic field on different body parts with the desired direc(cid:173)
`tion and amplitude.
`[007 4] The one or more coils may be stationary or movable
`within the housing, making it possible to optimize the direc(cid:173)
`tion of magnetic flow to the target nerve by disposing the coils
`in the most effective direction. In different variations, the
`coils may be movable manually by acting on a knob, lever, or
`similar type of actuator, or may be translated automatically by
`the logic controller in response to the input provided by the
`sensors. When a preferred position for the coils has been
`established, the coils may be locked in position and maintain
`that position during successive therapy sessions. In other
`variations, the sensors may be incorporated within the hous(cid:173)
`ing, or instead may be disposed on a body part of