CA2778963A1 - Method and apparatus for electromagnetic stimulation of nerve, muscle, and body tissues - Google Patents

Abstract

In certain variations, systems and/or methods for electromagnetic induction therapy are provided. One or more ergonomic or body contoured applicators may be included. The applicators include one or more conductive coils configured to generate an electromagnetic or magnetic field focused on a target nerve, muscle or other body tissues positioned in proximity to the coil. One or more sensors may be utilized to detect stimulation and to provide feedback about the efficacy of the applied electromagnetic induction therapy. A controller may be adjustable to vary a current through a coil to adjust the magnetic field focused upon the target nerve, muscle or other body tissues based on the feedback provide by a sensor or by a patient. In certain systems or methods, pulsed magnetic fields may be intermittently applied to a target nerve, muscle or tissue without causing habituation.

Description

METHOD AND APPARATUS FOR E LEC 1"R MAG E'iT S I IMI.fLA`I'i 3N OF
,,NERVE, MUSCLE, AND 'BODY TISSUES

CROSS-RE ERENCE TO RELATED APPLICATIONS
100011 The present application claims benefit of prioritjy to tr.S.
Provisional Patent Application Serial No. 41.'279,883 filed. October 26, 2009 which is incorporated by reference herein in its entirety for all purposes. The followi.rng applications are also incorporated herein by reference in their entirety for all purposes: U.S.
Patent Application, Serial No. 121508,529 filed July 23, 2009, which is a continuation in Part of U.S. Patent Application Serial No. 11 /866,329 filed October 2, 2007. which claims priority to U.S.
Provisional Patent Application Serial No. 60/848,720 filed October 2,2006;
U.S. Patent Application Serial No. 12/ÃX95,087 ..fried January 27,, 2010, which is a continuation of U.S.
Patent Application Serial Ncr. 11/3-312,797 filed January 17,2006', U,S, 'atent Application Serial Nos. 12/509,362 filed July 24,2009; 12/469, 365 filed May 20, 2009 which is a continuation of l.:.S. Patent Application Serial No. 11/866,329 filed October 2, 2007 which claims priority to U.S. Provisional Patent Application Serial No. 601"848,720 filed October 2, 2006, and 12.469,625 fled May 20, 2009 which is a continuation of U.S. Patent Application Serial No. 1 1/868,329 filed October 2, 2007 which claims priority to U,S.
Provisional Patent App! . cat. on Serial No. 60/848,7210 filed October 2, 2006; and 12/509,304, filed July-24,22009 which is a continuation of U.S. Patent Application Serial 'loo. 12.`508,529 filed July 23, 2009 ti hiclr is a contir-itration-irt-p~r_rt c?1 PI.S. Patent Application Serial No. 11,/866,329 t:rled October 2, 20Ã17 which claims priority to U.S. Provisional Patent Application Serial No.
60;=848, 7 20 filed October 2, 2006, and 121"509,34-5 filed July 24, 20Ã19 which. is a continuation oft.".S. Patent Application Serial No. 12,=508,529 filed July 23.
2009 which is a conÃintration-irr-part of U.S. Patent Application Serial' o. 11 `866,329 f led October 2, 2007 which claims priority to U.S. Provisional latent Application Serial No.
60/848,720 filed October 2, 2006, BACKGROUND
[00021 The concept of pulsed electromagnetic stimulation (PIES) was first observed by the renowned scientist Michael Faraday in 1831.:Faraday was able to demonstrate that time `:ar ing, or pulsed elect:iomagneuc fields have the potential. to induce current in t.
conductive object. Faraday's experimental setup was simple. He found that by passing ,strong electric current through a coil of wire Ir.e was able to produce pulsed electromagnetic stimuli. This pulsed electromagnetic stimulus was able to Ãr duce the flow of current in a nearby electrically conductive body.
100031 In the years since the discoveries of Faraday, pulsed electromagnetic stimulators have found application in countless areas of scientific :investigation. 111, 1965, the scientists Bickford and Frei-nim demonstrated the use of electromagnetic stimulation to induce conduction within nerves of the face. Later, in 1982 Folson et al., U.
S. Patent No.
5,763,124 produced a device capable of stimulating peripheral .nerves of the body. This device was able to stimulate peripheral. nerves of the body sufficiently to cause, muscle aactrvit r, recording the first evoked potentials from electromagnetic stimulation.
100041 One of the earliest practical applications of electromagnetic stimulating technology Wok the form of a bone growth stimulator --- a device that employed low frequency pulsed electromagnetic fields (f'p.MF) to stimulate bone repair.
They first found use approximately '0 years ago in the treatment of non healing fractures, and are slowly becoming the standard of care for this condition.
IOOO 1 As investigators have studied the effects of electromagnetic fields on fracture healing, it has been demonstrated that P.E MFs can not only facilitate fracture healing but also promote numerous other positive effects on the human body, including: (1) causing muscles to contract. (2) altering nerve sibgnal transmission to decrease experienced pain, and.

(3) causing new cell growth in cartilage. These powerful et ;c:ts of pulsed electromagnetic stimulation have been well established in laboratory studies of: anirnal models and also in multiple large, double blind, placebo controlled studies of human sÃrbjects published in the 215 medical literature, 100061 Erickson's U.S. Patent 5;181,9021, 11/26/ 1993; which describes a device using a. double transducer system with contoured, flat wound transducers intended to generate therapeutic flux-aided electromagnetic fields .11.1 the body. The device is suggested to be conformed to the contour of the patient's back and incorporates an adjustable belt into the design. This system, as it .is described, is disaad-,vvaantageous in at.
least. two respects. k irsÃ, the flat, wound nature of the coil in this device is limited in its delivery of pulsed electromagrnetic fields to deep tissues of the body, Second, the rigid nature of this device, intended to provide bracing for patients recovering from spinal fission surgeries, may prove uncomfortable to some patients, especially in delivering therapy to regions of the body other than the back, such as the knee, elbow, hared, or other.joi ats and tisstaes.
100071 L-'. S. Patent 6,086,525, which discloses a device that has a sin-le coil in the shape of a C" where the intensity of the electromagnetic field is between the ends of the "iC". That point must be employed directly over the target nerve or muscle to be stimulated.
The coil is toroidal .in con-figuration and utilizes a unique core of vanadium permendt r in the preferred form_ One of the disadvantages of this device is that it requires a trained technician to treat the patient and to properly hand hold the open end of the `C" over the targeted nerve or muscle to be stimulated. The device is not portable and is designed for use in hospitals or sinr.ilaar institutions. Also the vanadium per==.-.nmendtr.r core is required to increase the strength of the electromagnetic field to be strong enough to be effectively used.
The design, shape and configuration described in. Davey and other prior art devices, require the electromagnetic stimulator to be hand operated darning use.
[00081 Topper in U.S. Patent 5,314,401, 5.;2411/1994 describes a pulsed electromagnetic field transducer that is intended to be conformable to the contour of a patients body. The PFMF transducer it this application is described as having;
a. desired form and sufficient rigidity to maintaini an anatomical contour. 'T'his system is disadvantageous in a number of respects. First, the desired contouring of this device will require that a. significant number of different sizes be nsmarnufaactured to accommodate the contours of an endless variety of body shapes. Second. the intended device does not incorporate marking-, to ensure that the device is placed in a correct alignment over the tar xted area of the body. Finally, this proposed device utilizes flat, wound coils, providing PEMFs that do not penetrate as deeply or as uniformly into body tissues as those fields produced by solenoid coils.
100091 In U.S. Patent 6,179,7 70 B 1, 1 3 )0/200 1, Mould describes dual coil assemblies in a magnetic stimulator for .. euro$nuscular tissue. with cooling provided for the transducer coil. This device is intended to be held by a trained user over the targeted regions of the body in order to deliver PE VlF the.rapy. The design of this device is limited by the difficult nature of manipulating a single coil and the cost-i-a ensivC
requirement of using highly skilled medical personnel fir operation.
100101 Parker in U.S. Patent 6,155,966, 12/5'2000 describes a wearable article with.
a permanent magnet! electromagnet combination device to be used for toning tissue with focused, coherent EIMF. This device is disadvantageous in several respects.
First, this device is intended to be a hand-held application, with the user applying the device to targeted areas of the body. The hand-held nature of this application creates an irrherentl v inconsistent and non--uniforrin method for delÃv.-ery, especially difficult with. the intention. of the device to provide a focused ele ctrr~rà tà et.ic stimuliÃ:s. Second, the device combines a static magnet with the electromagnet assembly in. an attempt to create a unipolar, negative polarity field. This form of electron agnetic field stimulation has not been demonstrated to be effective in the treatment. of osteoartlrriÃis,.Ãmrtrsculoskeletrrl pain, or atrophy treatrrm.ent.
1001 i March's U. S. Patent 6,200,259 BI, 311IiMO1 describes a device with electroÃnagnetic field coils applied front and back to a patient for treating cardiovascular disease by angiog.euesis. An EMF dosage plan contemplates, multiple coil implants and pulse variables including carrier frequency, pulse drape. duty cycler and.
total time exposed. This device describes the placement of coils around the regions of tissues in which collateralizati.on of blood :flow (or angiogenesis) is desired. The design contemplates applications including the use of coils embedded in a cloth wrap, w vhich could be worn as a garment surrounding the body area of interest. Alternatively, an applicator with embedded coils to be placed around an arm. or a lea to deliver the desired field is described The use of PEMF in this application for the purpose of modulation of angiogenesis shows significant promise. The description of this device, however, does riot suggest any extension of the electromagnetic phenomenon. in circumstances where PEMF stimulation cats provide dramatic opportunities for the treatment of osteoar-thritis, and musculoskeletal pains including tendonritis, bursitis, and muscle spasms. Furthermore, this device is disadvantageous in the fact that it does not provide for the use of solenoid-type coils for the delivery of PEN-F, [01121 Poison's US, Patent 5;766;124, 61'1611998 describes a magnetic stimulator ofneuro-.muscular tissue. A reserve capacitor providintp, more efficiency in the control, circuitry is devised. The description of the device, however. describes the stimulating coil in broad, werieric terrns,, and does not coz t:eniplate application of the coil in any type of body applicator or other specific method for delivering PEMF to targeted areas of the body. As a result, this device is disadvantageous, in the respect that is does not provide for any method or delivery system. to provide consistent, uniform PEMF stimulation.
100131 Schwei4..hoferis U.S. Patent 6,123,658, 9.2E/2000 describes a nrraslwtetic stimulation device which consists of a stimulation coil, a high-voltage capacitor, and a controllable network part. This device is intended to differentiate itself lore low voltage, tow current devices b using a specific high- oltac e, hi4gh current: design to deliver PEMF
for the purpose of triggering action potentials in deep neuromuscular tissue.
This coill in this device is described as having a difficult and expensive to use hand-held configuration.
[0014j Lin in US, Patent 5,85T957, issued Jan. 12, 1999 teaches the use of functional magnetic stimulnion for the purpose of inducing a cough .functi.on in a mammalian subject, The description of the device provides for the use of hand-held stitrulatiorn coil, intended to be placed over the anterior chest of the subject for the purpose of stimulating nerves to induce a cough, This system is disadvantageous in the requirement of hand-held delivery which is dif icult and inconsistent, The description contemplates use of the device in the induction of cough; and does not contemplate extension of the use of the device into other areas of neuromuscular stirrmulation.
X00151 Tepper in U.S. Patent No. 6,02 ,6c91, issued 2/15/'2000 describes a cervical 210 collar with integral transducer for PEM F treatment, The description of this device provides f sr the use ofa single coil transducer, formed into the shape of a cervical.
coll.a.r. This system is disadvantageous in several respects, First, this device does not provide for the use of solenoid-t.ype coils in the delivery of f l M1=, which can provide a uniform and consistent signal. Second, the semi rigid design of the collar con plieates the deli-very of PE :t:F to 215 persons of differing body sizes. That is, for a person with a larger than average (or smaller than average) size nneck, the design and semi-rigid nature of the device would make an exacting fit difficult, thereby diminishing the effectiveness of any delivered therapy.
l=F urt.hertnore, this device is designed to immobilize the neck and is therefore not applicable to most patients. Lastly, the device must be lowered over the head making application 30 difficult.

[00161 Erickson in 1..'.S, Patent l o. 5,401 233, issued 3/28/1995 describes a neck collar device for the delivery of PEIv F therapy. The description of this device provides for the use of semi-rigid transducers, intended to be conformable to a selected anatomical contour. This device in disadvantageous in respects similar to those of Pollack 5,401,233, in that the device does not provide for the use o.f solenoid type coils.
Furthermore, this device is intended to provide bracing (as might be necessary for the treatment of fractures or after surgery). As a result, the rigidity of the device necessary to serve the bracing function makes the device less comfortable to wear, especially for a person who would not require bracing (such as in the treatment of arthritis, muscle spasm, or other forms of musculoskeletal pain).
[00171 Kolt in US, Patent No. 5,518,495, issued 5.21 / 1996 describes a coil wound on a (urge: bobbin that permits the insertion of an aim or a leg into the field of the coil for PEMF type therapy. This device is disadvantageous in several respects. First, the described use of a bobbin, trout d which the wire for the stimulating coil is wound provides for the treatment of certain areas of the body, but is certainly limited .in its ability to deliver therapy to areas of the body such. as the hips, shoulder, back, neck, etc, That is, the constraints of our human anatomy mike it nearly impossible to approximate a .tt.retal bobbin, and thus the stimulating coil., to regions of the body such as the ball and socket joints of the hip or shoulder, where the round metal bobbin would strike the torso before it allowed the stirs ula.ting coils to adequately blanket with therapy the arm and/or joint in the hip and shoulder. Similarly, The use of a metal bobbin for the deli-very ofPEMF
stimulation to the back would necessitate a large, cumbersome deli. erv system (into which the entire body would have to f t) in order to adequately deliver stimulation to targeted areas or the back or torso. Second, the device is described as a rigid bobbin through which the extremity is 215 placed. This format makes application. more difficult in that the applicator cannot be worn and therefore does not provide fear consistent ideal placement of the extremity to maximize field effects. In fact, most designs of a similar nature are clinic-based devices and, therefore, would not be amenable to home healthcare applications as with the current invention. Third, the device described magnetic field within the bobbin is intended to have a.
maximum r:ra netic: flrr density i.rr the range of 4.5 to 6 gauss. Studies (such as `frock et ai in tl-re Journal. of Rheurmratology 1994; 21(1 te): 190 --1911) leave shown that PEI
IF stimulation in tEte range of I5-2:5 or more 4eaiss are effective in the treatment of osteoarthritis or other nausculoskeletal. pain conditions, 100181 Pollack in U.S. Patent'No, 5,014,699, issued ti 14," 1991 describes a coil wound around the cast on an appendage for the delivery of PEMF treatment to fractured bone. The described device has shown promise for the treatment of fractured bone, especially nonunion or delayed healing fractures. However, the description of the devise does not provide for extension of this application to the treatment of other conditions, such as arthritis, musculosfeletal pain, or atrophy.

100191 Imran in US Pat App No 210061"005283 )9 filed 9 7/2005 describe the use of an.
iniplaratable stimulator for the treatment of chronic back pain. While this modality maybe effective at treating back pain; it requires a major surgery and will eventually suffer from habituation as the area around the needle fibroses and the nerve becomes deadened to repeated stinmlation.

1.1 SUMMARY
[00201 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 rierve, 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 ne.rvà , muscle or other body tissues and to provide feedback about the efficacy of the applied electromagnetic 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 f=ocused upon the target nerve, muscle or other body tissues. Optionally.>, 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.
100211 In. certain variations, the applicator may be configured 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.

[00221 In certain variations, methods, of electromagnetic induction therapy nay 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 maybe positioned relative to or in proximity to a first portion of a patient's body, such that a target nerve, n .uscle or tissue within the first portion of the body is in proximity to one or more conductive coils disposed. within or along the applicator. A current may be passed through a aril to generate a magnetic field focused or the target nerve, muscle or tissue. An electrical conduction through the target nerve, a muscular response caused by an electrical. conduction through the target 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 electrical. conduction or stimulation may be received, which provides feedback about the efficacy of the applied electromagnetic induction therapy. The current may be adjusted.
by a controller in communication with the conductive coils based on the feedback.
10231 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=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, wthout causing habituation.
[00241 In certain variations, applicators may be ergonomic or may be designed or configured to acconm moda_te, approximate 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 applicators, or the applicators may. be positioned relative to the specific regions of the body or anatomy to treat various conditions, for example, osteoaar hritis, arthritis, back or neck pain, atrophy or paralysis, chroni.c pain, phantom or neuropathic pain, neuralgia, migraines, orthopedic conditions.
100251 Other features and advantages will appear hereinafter. 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

[00261 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.
100271 FIG. 1 is a schematic view of an apparatus for magnetic induction therapy according to a first variation.

100281 FIG. 2 is a schematic view of an apparatus for magnetic i duction therapy according to a second variation.
100291 FIG, 3 is a schematic view of an apparatus for magnetic induction therapy according to a third variation, [00301 FIG. 4 is a schematic view of an apparatus for magnetic induction therapy according to a .fl urth variation.

[00311 FIG, 5 is a schematic view of an apparatus for magnetic induction therapy according to a fifth variation.
[00321 FIGS. 6A.-6D are schematic illustrations depicting a first method of use of an apparatus for magnetic induction therapy. This method. is based on aÃfjusting the position of the conductive coils so to optimize a magnetic flow applied to a target nerve.
100331 FIGS. 7A.-7D are schematic illustrations of a second method of use of an apparatus :tor magnetic induction therapy, This method is based on locking the conductive coils in position once electrical conduction in a target nerve has been detected.
100341 FIG. 8 is a schematic view of a variation that includes a plurality of sensors.
[0351 FIGS. 9A-9D are schematic representations of different garments adapted to operate as apparatus for magnetic .induction therapy.
100361 FIG. 10 is a schematic view of an apparatus f=or providin electrical stimulation, 100371 HG. 11. is a schematic view of another variation of an appar'atu for providing electrical stimulation, 100381 FIG. 12 shows a schematic vie~,w, of an energy errs. tt.irr system including a microneedle patch sensor.
[00391 1`[t_i. 13-15 shows .magnified bottom views of variations of microneedle patches.

X0040.1 FICI.`. 16-17 shoes magnified side views of variations of a micmneedle patch.
100411 FIG. 18 shows a magnified bottom perspective view of a .Ãtxicroneedle patch.
100421 FIG. 19 shows a representative cross sectional view of the skin composed of an. outer stratrrrn comeum covering the epider -real and dem a layers of skin and the underlying subcutaneous tissue, with a variation of a microneedle patch attached thereto.
1.00431 FIG. 20a shows a magnified side view o'a variation of a microueedle patch including multiple electrodes.
100441 FIG. 2Ob-2OI show variations of a microneedle patches including multiple electrodes.
[0045] FIG. 21 shows a schematic view of an cnc.t=g ' exrrittin ? s stc xrt inelrtclirrg a microneedle patch sensor placed behind a subject's knee.
[00461 FIGS. 22-2.3 show schematic views of energy emitting systems including an electrode needle and sensor.
1.5 100471 FIC:GS. 24-25 show schematic views of energy emitting systems Including an electrode needle without a sensor.
100481 FIG. 26 shows a schematic view of an energy emitting system including a microneedle patch for providing stimulation.
[00491 It ICS & a.. y7-28 show schematic views of energy emitting systems including an electrode needle and ricroneedle patch for providing stimulation.
100501 FIG. 29a-2.9d show a prospective, side., top and rear views of an.
energy emitting device in the from of a foot cradle.
100511 FIGS 3OA_30B show schematic views of an energy emitting device in the form of a knee support.

23 [00521 FIGs_ 3iA-3IB show a schei atic view of a variation of an arm applicator and a foot, knee or leg applicator.
100531 FIG, 32 shows a schematic view of a variation of a. back applicator.
100541 F RI. 33 shows a schematic vie~,w, of a variation of a system including a back applicator, a sensor and logic. controller.
[0055} 11G. 34 shows a schematic view of systen-i including, multiple back applicators, a sensor and logic controller.

[00561 :(IG. 35 shows a schematic view of a variation of a system.
incltadfii.; a back applicator held on a patient's body by an ergonomic positioning element. in the forma of a belt and a logic controller.
100571 FIG. 36 shows a schematic view of a variation of an applicator designed to stimulate a nerve responsible for phantom or neuropa hic pain.
100581 FIG. 37 shows a schematic view of a variation of a facial neuralgia aapplicaator_ 100591 FIG. 38 shows a schematic view of a variation of an applicator which may be placed over the occipital nerve for the treatment of migraine.
[00601 FIG. >9 shows a schemat c view of a variation of an aappl cator which mad be placed over the frontal cortex for the treatment of depression.
[00611 FIG. 40 shows a sc hemaatic, view of a variation an applicator in the .fo.rm of a stimulatory coil platform for positioning one or more coils in proximity to a 'knee or popliteaal. nerve.
[00621 FIG. 41 shows a schematic view of a system including 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.
100631 Figures 42A and 428 show an example of how the amount of stimulatory power required to achieve a desired stimulus may be automatically adjusted as a result of 210 fibroses.
100641 Figures 43.A and 4313 show variations of a coil device positioned on a skull.
DETAILED DESCRIPTION
[00651 In certain variations, apparatus and methods .f=or- magnetic induction therapy, 215 in which dosage of magnetic energy can be regulated according to conduction in a target nerve exposed to the magnetic field are provided.
100661 In certain variations, apparatus and methods for magnetic induction therapy, in which the flow of m anetic energy can be adjusted directionally by the patient or a healthcare provider without altering the position of a housing containing conductive coils 30 that produce the magnetic field are provided.

l1 [00671 in certain variations, apparatus and methods for treating a variety of ailments by providing energy . to a target nerve, for example magnetic ener'gy', electrical energy' or ultrasound energy, at a location and in an amount optimized by detecting conduction in tle target nerve are provided.
100681 In certain variations, an enerav emitting apparatus -or 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 es.lectri conduction in a target nerve, Much are connected to the logic controller is provided. The one or more energy generators produce energy focused on the target nerve upon receiving :r signal from the logic controller, and the applied energy is varied by the loggic controller according to an input provided by the one or more sensors based on electric conduction in the à rrget 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.
1.00691 The applied energy may be a magnetic field, an electrical field, an ultrasound, gat visible light, or an infrared or ar, ultraviolet energy. When a magnetic:
field is applied, they energy-emitting device is an apparatus that provides a magnetic induction therapy and that includes one or more conductive coils disposed in ri ergonomic housing. A
logic coritroller 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 frorr. the logic controller and produce 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; - requencyr or direction of the magnetic 215 field, or the firing sequence of the one or more coilsõ to be varied according to the efficiency of the treatment provided to the target nerve. In certain variations, the housin=g containing the conductive coils may be a flexible wrap, a. cradle or a garment., and the coils may be overlapping andior be disposed in different positions within the housing, so to generate a magnetic field on different body parts with the desired direction and amplitude.
100701 The one or more coils may be stationary or movable within the housing, raking it possible to optimize the direction of magnetic flow to the target nerve by.

l?

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 aratomat.ically 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 succe: sive therapy sessions. In other variations, the sensors may be incorprated within. the housing, or instead may be disposed on a body part of interest independently of the housing.
100711 In still other variations, the inductive coils are disposed in a housing that is situated externally to aÃ. patient's body, and additional inductive coils are implanted into the body of the patient and are magnetically coupled to the external inductive coils. With this coil arrangement, energy may be transmitted from the external coils to the internal coils either to recharge or to activate all implantable device, In yet other variations, the electric current may varied by the logic controller both on the basis of an input provided by the one or more sensors and also an input provided by the patient according to a muscular response she has perceived, for example, the twitching of a toe after application of the mat netic field.
[00721 In yet other variations, the source of energy for nerve stimulation may be electrical energy and nerve conduction may be detected at a site sufficiently distant -from the site of stimulation, so to enable detection of nerve conduction despite the.
confounding interference from the direct electrical stimuli. In these variations, direct electrical stimulation of nerve and muscle may be tailored to provide optimal therapy and, in the case of electrode migration or outer electrode nra_l.funct on, to report lack of stimulation of the bodily tissues.
Furthen,nore, these variations enable a reduction in power requirement, because control of the signal is provided by the sensor to the signal generator loop.
100731 In other variations, an energy emitting system for providing a medical 215 therapy is provided. The system may ià cltude one or more conductive coils disposed within or along a housing and configured to generate a magnetic field focused on a target .nerve in proximity to coils, one or more sensors in the form of microneedle patch configured to detect electrical conduction. in the target a ne.rve; and a controller coupled to the conductive coils and optionally in communication with the seÃnsor.
[074} In other variations, an energy emitting system for providing a medical therapy is provided. The system may include one or more microneedle patches having one or more nricroneedle arrays deposited on a surface of one or more electrodes and configured to generate or deliver an electrical or magnetic stimulus or -told -focusedon a target nerve n proximity to the rr ic:roneedle patch, one or more sensors configured to detect electrical, conduction in. the target nerve; and a controller corn: led to the conductive coils and optionally in communication with the sensor. Optionally, the above variations may incorporate an electrode needle. Optionally, the above variations or systems may be utilized without a sensor or mechanism for detecting Conduction or stimulation.
100751 Methods of use of the above apparatus, systems and variations thereof -for treating various conditions are also described herein, [0076 Referring first to FIG. 1, a first variation includes a coil wrap 20, which is depicted as disposed over ankle 22 circumferentially to surround a portion of tibial :serve 24.
Because tibial nerve 24.1s targeted, this variation is particularly suited for the treatment of OAB and VT. In other variations, coil wrap 20 may be configured to surround other body parts that contain a portion of tibial nerve 24 or of other nerves branching .from or connected 15, to ti vial nerve 24, still making these variations suitable for treating OAB and Vi. in still other variations, coil wrap 20 may be configured for surrotÃnding body parts that contain other nerves when treatments of other ailments are .intended.
100771 Coil wrap 20 may be manufactured from a variety of materials suitable for wearing ov=er ankle 22. Preferably, coil wrap is produced from. a soft, body--compatible material, natural or synthetic, for example, cotton, wool, polyester, rayon, Gore-Tex 8u, or other fibers or materials known to a person skilled in the art as nonirritating and preferably breathable when tailored into a garment. Coil wrap 22 may even be manyÃ.fiactured from a molded or cast synthetic material, such as a urethane gel., to add extra.
conxfort to the patient by providing a soft and drapable feel..,`Sddit:ionally, coil wrap 20 tna be produced from a single layer of material or from multiple material layers and may include padding or other filling between the layers.
100781 Coil wrap 20 contains one or more conductive coils 26 arranged to produce a pulsed magnetic field that will flow across tibial nerve 24 and generate a current that will flow along tibial nerve24 and spread along the length of tibial nerve 24 all the way to its sacral or pudendal nerve root origins Coils 26 may be a single coil shaped in a simple helical pattern or as a figure eight coil,, a four leaf clover coil, a Helmholtz coil, a modified Helmholtz coil, or may be shaped as a combination of the afc re.mm. entioned coils patterns.
Additionally-, other coil designs beyond those mentioned hereinabove night be -titili -zed as long as a magnetic field is developed that will encompass tibial. nerve 24 orany other tar .et nerve. When a plurality of coils is utilized, such coils may be disposed on a sin#gle side of ankle 22., or may be disposed on more than one side, for example, on opposing sides, strengthening and directionalizin;- the flow of the magnetic field through tibial nerve 24 or other peripheral nerves of interest.
100791 Coil wrap 20 is preferably configtmred as an ergo omic reap, for example , as a_n. essentially cylindrical band that can be pulled over ankle 22, or as an.
open hand that can be wrapped around ankle 22 and have its ends connected with a l uckle, a hoop and loop sy=stern, or any other closing system known to a person skilled in the art. By properly adjusting the position of coil wrap 20 over ankle 22, a patient or a health care provider rr aye optimize the flow of the magnetic field through tibial nerve 24, based on system feedback or on sensory perceptions of the patient, as described in greater detail below.
1:00801 The electric current that produces the rrragnetic field by lowin through coils 26 is supplied by a programmable logic controller-28, which is connected to coils 26. for example, s ith a power cord 32. A sensor 30 that .feeds information to logic controller 28.1s also provided, in order to tailor the strength. of the. magnetic field and control activation of coils 26 based on nerve conduction. The purpose of sensor 30 is to detect and record the firing of the target nerve and to provide related information to logic controller 28, so to render the intended therapy most effective. For example, sensor input may cause logic controller 28 to alter the strength or pulse am litude of the magnetic field based on sensor input, or fire the coils .in a certain sequence.
100811 In this variation, as well as in the other variations described hereinafter, sensor _ 0 may include one or more sensor patches and may be placed at different distances from the region of direct exposure to the magnetic field. For example, sensor 30 may be configured as a voltage or current detector in the form of an EKG patch and may be placed anywhere ire the vicinity of Ã1 e target nerve to detect its activation. For ease of description-the term "coils" will be used hereinafter to indicate "one or more coils" and "sensor" to indicate "cure or more sensors," unless specified otherwise.

[00821 By virtue of the above described arrant :eme at, coil a ap 20 provide,-, a reproducibly correct level of stimulation during an initial therapy session and during successive therapy sessions, because the presence or absence of -nerve conduction is detected and, in some variations, measured when coil wrap 20 is first fitted and fine-tuned on the patient. In addition to properly modulating the applied magnetic field.. the positioning of coils 26 over ankle 22 nay also be tailored. according to the input provided by sensor 30, so to fine-ttrrre the direction of the magnetic field. Such an adjustment of the direct.ioll, amplitude, and level of the stimulation provided to the target: nerve through the above described .automated feedback loop, to ensure that peripheral nerve conduction. is being achieved, is one of the key features.
[00831 If the magnetic pulse does not substantially interfere. with sensor-30, sensor 30 may, be placed directly within the .field of sun3.til rti:on, so that pov r upplied to the system may be conserved. This is particularly important for battery-powered systems.
Alternatively', sensor 30 may also be placed at a distance from the magnetic field and. still 1.5 properly detect neural. stimulation, [00841 In a method of use of coil wrap 20, the amplitude. and.`c r firing sequence of coils 26 ntayr be ramped up p.rogressively<, so that the imagnetic.-field is increased in strength anal/or- breadth until nerve conduction is detected, after which the applied stimulus is adjusted or maintained at its current level for the remainder of the tlxerapy.
'ihe level of stirs trlation may be also controlled through a combination of feedback from sensor 30 and feedback based on perceptions of the patient. For example, the patient may activate a switch once she perceives an excessive stimulation, in particular, an excessive level of muscular stir-rulation. In one instance, the patient may be asked to push. a button or turn a knob when she feels her toe twitching or when she experiences paresthesia over the sole of her foot. The 215 patient will then continue pressing the button or keep the knob in the rotated position until she can no longer feel her toe twitching or paresthesiaa in her foot, indicating that that level of applied stimulation corresponds to an optimal therapy level. From that point on, the patient may be instructed to simply retain her foot, knee, or other limb within coil .rap 20 until therapy has been terminated. while the system is kept at the optimal level, Adding patient input enables control of coil w crap 20 during outpatient treat rents, because the patient is no able to adjust the intensity of the naag;netic field herself beyond the signals provided to logic controller 28 by sensor 30.
100851 Detecting and, if the case, measuring. conduction in one or more.nerr es along the conduction pathways of the stimulated. nerve confirms that the target nerve has been stimulated, providing an accurate assessment of the efficiency of the applied therapy on the patient. A concomitant detection of muscle contraction may also confirm that the target nerve is being stimulated and provide an indication to the patient or to a healthcare provider as to whether stimulation has been applied at an excessive level in view of the anatomical aaa.d physiological characteristics of the patient.
1.00861 Based on the foregoing, coil y ap 20 allows fora consistent, user-friendly targeting and modulation of the peripheral nerves via the posterior tibial nerve on an outpatient basis. in particular, the tar eting and rmraodulation of the pudendal nerve and of the sacral plexus. When multiple coils 26 are present, coils 26 may be activated simultaneously or differentially to generate the desired magnetic field. The direction and location. of each of coils 26 may be reversibly or irreversibly adjusted by the. healthcare provider or by the patient, customizing the location of the applied stimulation to the anatomy and therapy needs of each patient. After a healthcare provider has optimized position and firing sequence for each of coils 26, the patient. may be sent ]ionic with coil wrap 20 adjusted to consistently tar get the desired nerve. In one variant of the present variation, an automatic feedback system aÃ.tjusts one or more of firing secluence, firing strength or position of coils 26 within coil Wrap 20 during the initial setup and also during successive therapy Sessions.
100871 In stirnmary, certain variations include the creation of a loop consisting of feeding information. on nerve conduction to logic controller 28 and on logic controller 28 tailorin the electrical current sent to coil wrap 20 taccordi_n to the information received from sensor 26 based on whether or not the nerve is receiving the desired.
stimulation and, in some variations, the desired amount of stimulation. This arrangement offers an unparalleled level of therapy control and flexibility within a horne care setting, because a consistent., repeatable stimulation of the target nerve can be attained. Aside from adjusting the position of coils-'76 in accordance with the patient's anatomy and physiological variations, controlling pulse amplitude is also of great importance even during; different therapy sessions with the same patient. For example, a patient with leg edema will encounter difficulties in properly a justing coil wrap 220 based on whether her legs and ankles are swollen or not swollen, and the power required to penetrate to posterior tibial nerve 24 (in the case of a VI therapy) will vary greatly due to the variable depth of the nerve, Thus, having feedback provided by sensor 26 becomes a necessity for achieving an accurate dosage of the treatment rather than an option.:Benchtop testing has demonstrated that a systein constructed as described herein is capable of non-invasively generating electrical currents similar to those found in therapeutic eletta'o-stiaratÃlaatio:a and to do so in difÃYrent settings.
100881 Referring now to F [G, 2, a second variation will be described with refere ace to a coil wrap 34 disposed over ankle 36 for the purpose of treating V1 by targeting tibia!
nerve 3&, In this second variation, one or more Helmholtz coils 40 are disposed within coil wrap 34 to create a more narrowly directed mag aetic. field over trial nerve 38, Like in the all other variations described herein, more than one coil. (in the present variation, more than one Helmholtz coil 40) may be placed within coil wrap 34 and be disposed in different positions within coil wrap 34, in order to optimize t iagnetic..1-lux over trial nerve. For example, two Helmholtz coils may be disposed one opposite to the other- within coil wwwra 34.
10089 Having coil windings arranged along a common longitudinal axis, as required I'll. a llelÃmtalaoltz coil coil f g ration, generates a more focused magnetic field and a more accurate tar4getin of tibial nerve 38 or of any other nerve. Like in the previous variation, the operation of coils 40 is controlled by a logic controller 42, which is in turn connected to sensor 44 that monitors conduction i.n tibial nerve 44 and that generates a feedback to logic controller 42 about the efficiency of the therapy in progress. Therefore, like in the previous variation, the coupling of sensor 44 with logic controller 42 optimizes operation of coil. wrap 34 according to results measured at the level of tibial nerve 38. Also like in the previous variation, manual adf_jtt tments to the parameters of electric current provided by logic controller 42 to.Hel.naholtz coil 40 may also be .made naanuaally by the patient or by a healthcare provider, and. coil wrap 34 may be structure d. so that the position of Helmholtz coi140 within. coil wrap 34 is aaclj usted as desired either manually by the patient or by a healthcare provider, or automatically= by lo4gic controller 42.
[0()90} Referring now to l: IG. 3. a third variation includes a coil wrap 46 configured for wrapping over the popliteal fossa of a patient, in the region of the knee, to stimulate the is posterior tibial nerve (.not shown), `I` le configuration and structure of coil wrap 46 reflect the body portion covered by coil wrap 46, but the key system components of coil.
wrap 46, such as the type; number and disposition of the coils (for exaà .mple, the use of o's erl.app n., coil. );
the connections of the coils with a logic controller; and the use of one or more sensors (also not showÃ) to detect nerve conduction are all comparable to those in the previously described variations.
1.00911 Referring now to FIG. 4, a fourth variation includes a. footrest or foot cradle 48, which is structured to contain at least a portion of afoot 50. One or more coils 5-2 are enclosed within cradle 48, and a sensor 54 is disposed along the pathway of tibial nerve 55, sensing conduction in tibial nerve 55, and is also connected to a logic controller 56. Coils 52, sensor 54 and logic controller 56 may be arranged in different configurations, in the same manner as in the preceding variati.ons.
100921 Cradle 48 may be made from a variety of materials and may be monolithic, or have a hollow or se.Ãni-hollow structure to enable the movement of coils 52 within cradle 48.
15, as described in greater detail below, 'refer-ably, cradle 48 has an ergonomically design allowing the ankle and heel of the patient to be retained within. cradle 48, in a position that matches the positions of stimulating coils 52 to the area of stimulation. The design of cradle 48 provides fora particularly comfortable delivery of therapy to patients that prefer to remain seated during their therapy, and enables the patient to perform the required therapy within a health care facility, or to take cradle 48 home, typically after an initial session and appropriate: training in a health care flicility. in that event, the patient will be trained to apply sensor 54 autonomously and to adjust stimulation to a comfortable level, 100931 FIG. 4 shows coils 52 disposed as over lappinag and the use of a single sensor patch 54 positioned proximally= to the stimulation site. l lowever, coil 52 may be configured as a single coil, a figure eight coil., a fbur leaf clover coil, a Helmholtz coil, a modified Helmholtz coil. or a a:ny combination of the aforementioned coils, or as any other coil design providing all effective stimulation, to the target nerve. In addition, coils 52 may be fired inndividuallyr, sequentially or simult.aneously according to the feedback.
provided by sensor 5.
[0094} In one variant of this variation, sensor 54 may include a conductive electrode patch that provides a feedback to logic controller 56 for adjusting, if necessary, the stimulation parameters. of coils :52. Alternatively, sensor 54 may be a sensor patch that is either applied to the skin of the patient or is incorporated within the structure of cradle 48.
100951 Referring now to FIG. 5, a fifth. variation includes a knee rest or knee cradle 58 that contains one or more conductive coils 60, one or more sensors 62 and a logic controller 64. The components of this variation are similar to those described with reference to the preceding variations, as regards the structure and materials of cradle 58, the nature and disposition of coils 60, the type and operation of sensor 62, and the function and operation of logic controller 64. Cradle 5$ is configured to target the popliteal f3ssa of the patient, thus to target tibial nerve 66. In that respect, the present variation is similar to the variation illustrated in FIG. 3, but while the variation of FIG. 3 is configured as a w -rap that :maybe worn while the patient is starnding, the present variation is configured as a cradle that is more suited for treatment while the patient is sitting or laying down.
100961 A method of use of the foot cradle depicted in FIG. 4 is described with reference to FIGS. 6A-6D. During a first step illustrated in FIG. 6A, foot 68 is disposed in cradle 70 that contains one or more conductive coils 72, which are connected to a logic controller (not shown) that manages the flow of electric power to coils 72, 100971 During, a second step illustrated in FIG. 613õ a sensor 74 is disposed on foot 68 or on. ankle 6 or on another appropriate portion of the patient's body, in order to detect conductivity in tibial .nerve 78 or in another target nerve.
[0098j During a third step illustrated in FIG, 6C, a healthcare provider analyzes conductivity measurements provided by sensor 74 (for exanmple by .reading gau(e 77) and first adjusts the positioning of coils 72 until conduction in nerve 78 is detected. For example the healthcare provider mrra = rotate a knob 80, slide a lever or actuate any other displacement system for coils 72 that is known in the art, so that coils 72 are translated until a ma4, netic field of the proper amplitude and intensity is applied. to cause conduction in nerve 78. The position of coils 72 is then fine-tuned manually until an optimal level of conduction, in nerve 78 is aattained, and the therapy is continued for a length of time as prescribed by, the attending healthcare provider.
10991 During a fourth, optional step illustrated in FIG. 613, settings for successive therapy sessions are set, for example by locking knob 80 (in one variation, with a pin 81) so that the healthcare provider or the patient repeat the therapy, using the predetermined settin4Xs, lterrtativel ,r, the patient ma4 be trained to adjust the arnplitude and/Or strength of the applied magnetic field as each therapy session reqvires, 101001 While the present method l .as been described with regard to foot cradle 70, the same method steps may be envisioned for coil wraps or cradles of different configurations.
for example, for the coil wraps and cradles described with re.f=erence to the previous fgUres.
[01011 In an alternative variation, the logic controller (not shown may automatically adjust coil positioning to optimize therapy during the initial and successive sessions. While dais set-up rasa I?e more d' iÃiElt: to Implement it also provides for an accurate tan>,"etin Of the target nerve during each therapy session?, regardless of alterations in patient positioning or changes to the anatomy of the patient (for example, when a foot is swollen). In this variation, the device simply varies the orientation of coils 84 until stimulation has been sensed.
101021 Further, coils 84 may be translated aalon a single direction (for example, horizontally) or along a plurality of directions, to provide for the most accurate positioning of coils 84 with respect to the target nerve.
[01031 A second method of use of the foot cradle depicted in FIG, 4 is described. now with reference to FI(:i, 7. While this second method is also described with reference to a toot cradle 82 employing one or more coils 84 that have a reversibly lockable, adjustable orientation, the present method may be equally implemented with a body-worn.
coil wrap.
such as those described with reference to the previous fi tires, or to other variations. In this method, the patient or- the healthcare provider adjusts the positioning of coils 84 to detect conductivity in target ne.rve. 89, 101.041 The position of coils 84 may be translated in different directions (in the illustrated variation, may be translated horizontally) and may be locked in an initial position 215 once conduction ir:a nerve $9 is detected by a sensor (for example, sensing catch. 86).
[01051 More particularly, FIG. 7A illustrates the -initial positioning of foot 88 into cradle 82 and of sensor patch 86 on ankle 90 or other appropriate body part of the patient. After proper positioning of .foot 88 is attained, a .knob 92 (or other equivalent device) may. be employed to aà just the position of coils 84, based on the signals (tor example, nerve conduction signals) provided by sensor patch 86, as shown in I-l:G. 713.

[01061 With reference to FIG. 7C', after neural conduction is detected, coils 84 are locked in place, and, with further reference to FIG. 71), foot cradle',--,'-) retains coils 84 locked .in position for further use 1.11a home or healthcare office environment.
Therefore, in the present method, the patient or a healthcare provider simply adjusts coil position by sliding coils 84 back and alone one axis until electric conduction in the target nerve is detected, although adjustments along all three axes may be possible in different variants of the present variation.
(I)I07I Referring now to FIG. 8, a sixth variation relates to the use of multiple sensors.
While FIG. 8 depicts a variation shaped as a foot cradle 98, it should be understood that the following description also relates to any other design., whether shaped as a cradle or a wrap or otherwise. The plurality of sensors 94 described herein may detect a variety of physiologic changes, .ir?cl.rtcling, neural impulses, muscular contraction., twitching, etc. that may occur with neural or muscular stimulation.
104.081 One or Store of the illustrated sensors 94 n.uy be employed over body regions being stimulated (for example, back, leg, arnt., neck., head, torso, etc.) and may be either incorporated within an actual cradle or w rap or, otherwise, be applied separately from the cradle or the wrap.
1ÃI: 091 Sensors 94 rrrary be structured as cti posa:ble, sirr le trye:; EKG-type, patches that are attached to the body outside of cradle 98 along the nerve conduction pathway and are then connected to the logic controller (not shown) before beginning therapy, This arrange .rent provides.f o.r an intimate body contact of sensors 94 without the risk of in.lection.
or other detrimental side effects that may be present with transc:utaneous devices. Sensors 94 may be employed both for beginning and for monitoring the stimulation therafpy; more spec:ificall , sensors 94 rrta be employed during the l eairt.Ãt.in of the therapy to optiMire 215 the strength. of the. magnetic, field and or to adjust the positioning of coils 96 within the cradle 98, Once therapy has begun, sensors 94 continue to monitor nerve conduction to ensure that the correct level of stimulation is being provided, In the event that for some reason nerve conduction decays during therapy=, the logic controller can a rutomat_icaally adjust the magnetic field, ensuring that the appropriate therapy is delivered for the appropriate amount of time.

[01101 One or more of sensors 94 in this -vatiation, or any of the variations describe herein, t nay take the form of an inductive coil. designed to receive impulses from the underlying nerves, so that inductive technologies may be used to both stimulate the nerve or tissues as well as to record the effect of the stimulation on nerves or tissues. Any of sensors 94 ma be connected to the Ionic controller through one or more connection modes, including, but not limited to, wireless signals, wired signals, radio frequencies, luetootla., infrared, ultrasound, direct switching of the current circuit, etc., so long as communication between the sensor and the device is effective.
10111 During implementation of the present method,. a healthcare provider may simply elect to use sensors 94 to adjust the device, for example, to lock coils 96 into position, during the first therapy session and not requiree, the use of sensors 94 during each successive therapy session.
[0112 Referring now to FIGS. 9A-9D, there are shown different, non-limiting variations shaped as body worn ergonomic applicator garments. Each, of these variations is sho w rn with over tipping coils, although coils of any: configurations may be used. Each of the wraps of FIGS. 9A-9D corresponds to a coil wrap, into which a body part may be placed, These garments contain one or more sensors (not shown) that provide f=eedback to a log is controller (also not shown), or sensors may be applied separately from those garinernts.
Systems may also be included for reversibly or irreversibly locking- the coils within the applicator, 101131 More particularly- FIG. 9A illustrates a variation, in which coils 100 are embedded in a knee wrap 102 and are connected to a logic controller (not shown) by a connector 104. l="IG. 98 instead illustrates a variation, .in which coils 106 are disposed within an abdominal garment, for example shorts 108 and in which coils 106 are also connected to a logic controller (not shown) by a connector 110. A marking 112 may be added on one side of shorts 108 to indicate wrap orientation. FIG. 9C illustrates a coil wrap shaped like a band 114, in which coils 116 are connected to a logic controller (not shown) by a connector 11 S.
When this variation is employed, bared 114 may be wrapped around a body portion (for example, an arm) and be retained in place by a system known in the art, for example, a book and loop systerrm, a strap and buckle system, or simply a hook disposed at one end of band 114 for engaging fabric or other material in another portion of band 114. FIG.
90 illustrates a variaà on shaped as a shoulder strap 120, the length of which may lie adjusted by a buckle 122 and which has coils 124 disposed in one or more points, for example, at the. joint between an arm and a shoulder as shown. Each of these variations includes one or ore sensors (.rot she n) that may be coupled to the garment, or that may be applied separately from the <. arrrr ent.
[01141 Other variations that are not illustrated include, bur are not limited to: a head worn garment, such as a cap-, a neck. worn garment, such as a neck brace, and a .lower-back.
garment. Each garment and applicator may also utilize the locking, targeting coil feature described previously, withcnit requiring the use of the any sensing components after a. proper positioning of the coils in relation to the target nerve or nerves has been established, [0115j Still other variations are depicted in FIGS. 10 and 11, In these variations, the source of energy for nerve stimulation is electrical energy that is dispensed through. a percutaneous stimulator, such as a percutaneotr:s needle 124, or a traarascaataarae ores stirratalator, such as an electrode 126. As shown it l~:1 G. 10, an electrical pulse controller 12-8 is electrically co anected both to percataneous needle 124 and to sensor 134, to provide the desired feedback and modulate the power to percutaneous needle 134. In the variation of FIC, 11, electrical pulse controller 130 is connected both to electrode 126 and to sensor 136, anad performs a function similar to that of electrical pulse controller 128.
With these variations, nerve conduction may be detected at a site sufficiently distant from. the site of stimulation, so to enable detection of nerve conduction despite the confounding interference from the direct electrical stimuli. Further, direct electrical stimulation of nerve and muscle may be tailored to provide optimal therapy and, in the case of electrode migration or other electrode malfunction, to report lack of stimulation of the bodily tissues.
Still further, these variations enable a reduction in power requirement, because control of the signal is provided by the sensor to the signal generator loop.
101161 As shown, a device constructed according to the principles described herein provides a targeted and precise stimulation of the posterior tibial nerve, or of other peripheral nerves, in a non-invasive manner by emplovin an ergonomic wrap or cradle that specifically targets the posterior tibial nerve in a consistent and repeatable manner. For example, in patients with O AB or Vl, the novel, reversibly lockable movement of the coils and the use of a logic controller -sensor loop enables the application of a magnetic field that can be varied in location, amplitude and strength according to the amo-urit of stimulation ,actually irnelarc.ed in one or more tam=et nerves and of the response of the patient to the therapy. An apparatus according to the variations described herein may deliver any frequency of stimulation, including low frequencies, high frequencies, mid frequencies and ultrahigh frequencies, and overlapping aatd .non-o~ erlal pi.n4 coils may be used to generate the desired field; although overlapping or Helmholtz coils are preferred due to their ability to target a broader region and achieve more. thorough stimulation..
101171 Ailments that may be treated through the use of apparatus and methods as described herein include not only QAB and V:1, but also obesity, depression, urinary incontinence, fecal incontinence, hypertension, pain, back pain, restless leg syndrome, Guillain Barre syndrome, quadriplegia, paraplegia, diabetic polynearopthy, dyskinesias, paresthesias. dental procedure pain, knee osteoarthritis, anesthesia (pain relief durin surgery), Alzheimer's disease:., angina (chest pain from heart disease), ankylosing spondyli tis, back pain, bum pain, cancer pain, chronic pain, dysmenorrhea (painful menstruation), headache, hemiplegia, hemiparesis (paralysis on one side of the body), labor pain, local anesthesia during gallstone lithotripsy, facial pain, tri geminaal netaralgiaa, brtaatism (tooth grinding) pain, myofascial pain, pregnancy-.related nausea or vomiting, neck and shoulder pairs, pain. from broken bones, rib fracture or acute trauma, diabetic peripheral neuropathy, phantoms limb pain, post-herpetic neuralgia (pain after :shingles), postoperative ileus (bowel obstruction), irritable bowel syndrome, postoperative nausea or vomiting, postoperative pain, post-stroke rehabilitation, rheumatoid arthritis, skin ulcers, spinal cord.
injury, temporomandibtrlar joint pain, detrtasor instability, spinal muscular atrophy (in children}, pain darning l-ts steroscopy, gastropa e51s, c:h_ronic: obstructive pulmonary disease rehabilitation, carpal tunnel syndrome soft tissue. injury, multiple sclerosis, intermittent claudication, attention-deficit hyperactivity disorder (A17HD), cognitive impairment, knee replacement pain, a.chalasia., atopic eczema, bursitis,, carpal tunnel syndrome, dementiaõ
depression, dry mouth, dystonia, enhanced blood flow in the brain, enhanced blood perfusion of the uterus and placenta, esophageal spasm, fibr-o.myalgia, fracture pain, Guillain-Barre syndrome, hemophilia, herpes, hip pain, interstitial cystitis, irritable bowel syndrome, pruriti.s, joint pain, labor induction,. local anesthesia, menstrual cramps, n uncle cramps, muscle spasticity, muscle strain or pain, musculoskelettaal traumaõ
myofascial pain dysfunction ' y.udrot - e, nee- ve damage, o'teoart ?iritir; pin t i:edicaÃnor adjunct, panereatflis Raynaud`s phenomenon, repetitive strain in..ua'ies; sacral pain, sci i.zo hrenias shingles, ,shoulder sribluxatio.n, sickle cell anemia pain, Skin flap ischemia (during plastic surgery).
sphincter of Oddi disorders, sports injuries, tl t'ombophlebitis, tinÃtitus (ringing n the ear), restless legs, tremor., whiplash and ..net.ra:lgias. In contrast to implantable nerve stimulator,,-,, this therapy is completely non-invasive and does not require a major surgery to à mplant a permanent nerve stimulation device. Moreover-, this therapy can be controlled to optimize the level of therapy delivered according to power consumption and -?erve stimul ationn requirements and need not be delivered by a professional healthcare provider.
[:01.181 In other variations, neural stimulation may be applied as electrical transcrtaneous stimulation, for example, by inserting an invasive electrical needle into a target body part and by modulating stimulation is modulated on the basis of i.t~ibr aÃic?a sent back to the logic controller from the one or Ãr ore se isors that are used to detect and/or maintain the correct level of stimulation. The transcutaneous electrical stimulation sensor may be placed in the body independently or be incorporated within the wrap and may provide, a tton.g other things, feedback is to the quality of the electrical connection to the skin, which is directly related to the bun-- risk inherently associated with this type of therapy. ltn :f=act, these methods of stimulation may not be optimal. due to the resulting skin irritation and risk of potent: aal bums, a very serious issue in the large percentage of patients that have neuropathies. Even 210 when patches are applied to monitor transcutaaneous stimulation very closely, the patches may still become displaced and allow a bum to occur. L oreover, potentially inter- erint, electrical impulses may develop at the treatment site, creating a noisy environment for the detection of nerve conduction 101191 In shill other variations, an external coil oir coils ma be inductively connected to an implanted coil. or coils :mmatay be utilized. In these variations, an ergonomic applicator may be adjusted by the user or by a healthcare provider such to optimize inductive power transmission between the external and implanted coils, One or more sensors may be utilized to provide a - eedb ack that the relative coil positions have been optimized, and the external.
coil may then be reversibly locked. into position within the ergonomic.
applicator. Two applications of this variation relate to the transfer of power to recharg,,e an implantable device, and to the transfer of power to activate an implantable device.

[01201 In the first application, when an implantable rechargeable device is utilized., the external coils may be used :.fi r recharging the implanted device by means of inductive fields generated by the external coils. The external coils may include circuitry that determines the amount of resistance encountered by the magnetic field or other electrical properties related to the quality and degree of the magnetic coupling that is being established.
Based on this feedback, the position of the external coils may be adjusted manually or atrtomaticallyr to optimize the coup ling achieved with during each recharging session.
A.lterraaatively:<, a sensor may be incorporated irnto the ir-rrplantable device and may corn municate the degree and quality of the magnetic coupling to the external coils and/or the connected circuitry via wireless communication, providing a feedback for the automatic or manual adjustment of the external recharging coils.
[01211 The coils within the ergonomic applicator may be reversibly locked into place (-or the duration of the recharge session, and the implantable device may also communicate to the external recharging unit that the implantable device has been fully recharged, terminating the rechargin session has been completed. By providing for an intermittent _g C
recharging of an implanted device, an ,apparatus according as described herein enables the inapla.ntable device to devote r more power to performing its intended function optimally and with a lesser concern about protecting or extending battery life, [Ã11221 In the second application, the powering coils may contain circuitry to determine the amount of resistance encountered by the applied magnetic field, or other electrical properties that may reflect the Ãluality and degree of the magnetic coupling that is being achieved, Based on this feedback, the powering coils in the applicator may be adjusted m aanuaally or automatically to activate and optimize the coil coupling at the beginning of each therapy session. Alternatively, a sensor may be incorporated into the implantable device and communicate the degree and quality of the a aagnetic coupling externally via.
wireless communication, which may in turn provide feedback for the automatic or .manual adjustment of the powering coil, In one variant of the present variation, the inductive coils may be m agneticaa;lly coupled to a needle taar geeing the posterior tibial nen.'e.
110231 An exemplary method of use of an apparatus as described herein on a patient suffering troraa. Vl. and/or OAR includes the .follorv ira I"f steps:

[0.1241 The patient places a conductive wrap contained ith.itm a flexible material over a region of the ankle (or alternatively: over the knee) to provide the required pulsed magnetic field. Alternatively, the patient may use an ergonomic foot/leg rest or cradle having embedded coils.
104.251 A sensor (for example, a sensor patch) is placed on the patient's body along the path of the nerve, ideally proximal. to the, stimulation site to ensure afferent nerve stimulation', and is connected to a logic controller.
101261 A physician or healthcare provider a justs the coils in the wrap or cradle until nerve conduction is achieved based on patient and sensor feedback, An optimal position is sought, and the coils may be reversibly locked into position within the conductive wrap or ergonomic cradle and remain in this position during s bsequent use.
[01271 During the therapy session, the logic controller provides an electric current to the coils, generating an inductive magnetic field. In one variation, this field begins at low amplitude and slowly ramps tip until nerve conduction exceeds a threshold.
level-, as signaled by the sensor and possibly by the patient, who may feel motor y conduction.
Altertr.atively.
one or more coils may also be activated_ to increase the covered, area of stimulation in the event that stimulation. does not occur with the initial coil configuration or is inadequate 10.1.281 The. optimal stimulation may be determined in a variety of manners, for example, by measuring exposure to electromagnetic fields capable of generating a square wave electric signal a:t a. frequency of 10-30 Hz at the targeted tissue depth, The square wave configuration of the signal may be *enerated via Fourier transformation or may be a ramped current generated in any manner.
104.291 The inductive magnetic pulses continue for an. appropriate duration of use, for example, for 15-30 minutes. The sensor may remain in place during the entire therapy session to ensure that stimulation occurs consistently and to provide for appropriate corrections if nerve conduction deteriorated. The logic controller may be powered either by a. portable power source such, as a battery, or by or a fixed, power source such as a traditional Wall outlet.
1101301 The conductive wrap and/or ergonomic cradle is removed from the body wN-hen therapeutic stimulation .is not being delivered,., typically at the end of the therapy session.
2$

[01311 The conductive wrz-1) and./or ergonomic cradle is reapplied along with the sensor patch (ideally disposable) from time to time as indicated, for e: arrmrple, on a daily basis, and steps 4-8 are repeated.
101321 The devices and. methods described herein may be applied to any body tissues, including nerve, muscle skin, vasculature, or any other organ or tissue within the flUman body. Further, the devices and methods described herein may be used to treat any conditions suited for neuromodulation regardless of whether the stimulation. source is an electromagnetic field, a direct electric current, a RF field, infrared energy, risible light, ultraviolet light, ultrasound, or other energy dispensing duke.
1:111331 In other variations, as shown in FIG. 1.2, an enertyT emitting system 210 for providing a medical therapy includes one or more conductive coils 212 disposed within or along a housing 214, one or more sensors 21Ãi configured to detect electrical conduction i.n a target nerve or to detect muscle stimulation, and a controller 218 connected or coupled to the conductive coils 212 and optionally in communication with. the sensor 2 i Ã?.
In cermit variations (as shown in Fig, 12), the controller 218 can be integral with the housing 214).
The coils 212. are configured such that an electrical current generated by the controller 218 is passed through the coils 21.2 generating a mad rretic field which will stimulate a target nerve, e.g., the tibial nerve 220~ a muscle or other body part containing a portion of a taret:nerv e, or any nerves branching off of a target nerve, located in proximity to the coils 212, hr this particular variation, the housing 214 is in the form of a foot cradle, as shown in FIG. 4, however, the housing could also be in the form of a flexible wrap, garment or other design suitable for use with a subject, In various variations described herein, sensors may detect voltage or current and may be connected, coupled, wirelessly connected or coupled or otherwise in communication with the housing and/Ã r controller using a variety of methods or techniques known. in the art. The sensor may be placed over a. muscle to detect muscle stimulation resulting from stimulating the target nerve (as shown in Fig. 12) or over any other portion of the subject's body suitable for detecting conduction of the target nerve.
104.341 Referd.nu to FIG 1:3 and 16, the sensor may be in the form of a microneedle patch 228, which can be removably attached to the skin surf=ace of a subject. The microneedle patch 228 may include a housing 231, having, one or more electrodes 232 and one or more microneedles 235 deposited or arrayed on a surface of the electrode 232, forming one, or more microneedle arrays 2' )4, In FIG 13, araicroneedle patch 21.18 has the shape of a square, and the naicroneedles 235 are arrayed on the bottom surface 236 ofthe:
electrode 232 in a 16 X 16 configuration. However, as shown in FIGS 14-15, microneedle patches may be designed in a variety of shapes, e.g., round, oval 229, rectangular 230, hexagonal. and a variety of sizes. The i-nicroneedles mays be arrayed in a variety of arrangements and patterns (e.g,, 14 X 14, 12 X 12, etc.) depending on the particular use and needles, 1.04351 Additionally, microneedles may be attached, deposited, or arrayed. on an electrode surface or patch .in a variety of configurations and arrangements, dependiÃ14g oat.
where the particular microneedle patch will. be utilized and the treatment to be delivered.
The number of microaaeedles included in an array can ar ~. For example, the Ã
umber of microneedles may range from about. 5 to 500 or 100 to 400 or about 200 to 300 or about 256. In. certain variations where naicroneedles are composed of strong, lai xlrl conductive material, the number of mic.roneedles necessary maybe less and may range from about 5 to 100 or 10 to 50 or 5 to 50. 1-lowever, where mi.croneedles are composed of higher resistance metal., a greater number of .needles may be needed, e.g., about 100 to 500 or about 200 to 300 or greater tlhaaan 500.
101361 Referring to .laIG, IS, a magnified view of a microneedle arra 234 composed of one or more microneedles 235 is shown. M.icr.-oneedles 233 may include a base portion 238 and an upper portion 239. _Microneedles 235 may have lengths in the range of about I to 400 microns or 10 to 400 microns or preferably about 100 to 15Ã3 microns, and a diameter in the ran e of about I. to 100 microns..A Ãaaicroneedle 235 may be tapered in.
diameter, going from a larger to smaller diameter from the base portion 23$ to the tapper portion 239 where the distal tip 240 of the microneedle is preferably pointed or sham. The upper portion 2 3 9 of the n aicroneedle 235 may have a diameter in. the range of about 10-30 microns or about 15 to 25 microns. Optionally, to:r case of production, the base portion '238 of the arilcroneedle:
235 may be thicker than the distal tip 240 or upper portion 239 of the microneedle 235. In certain variations, as shown in. FIG 17, a bulb 237 may be provided at the distal tip 240 ofa n .icroneedie 235 to provide .fh.r effective anchoring of the microneedle 2 35 in the skin of a patient or sithject. M:icroneedles 335 can iaacltade any number of friction or grip increasing features. For example, they may include projections, barbs. bulbs or a roughened surface or tip. Mic,roneec les 235 may take on various configurations, e g., straight lent, filtered.
hollow or a combination. o:ftl the above.
101371 in other variations, microneedles may have lengths that range from about 480 to 1450 microns, widths from about 160 to 470 microns, thicknesses from about 30 to 100 microns and tip angles from about 20 to 90 degrees, and arrays can contain from 5 to 50 microneedles. For example, microneedles having these dimensions have been shown to be less painful than hypodermic needles. Length and number ofmicroneedles can affect the level of pain experienced. Decreasing n .ieroneedle length and/'or the number of microneedles may be beneficial and act to further reduce pain and provide comfort.
1Ã1 1.01381 In certain variations, the one or more microneedles may include an electrically conductive material such that the microneedles may transmit an electrical signal to an overlying electrode or other surface. N1icroneedles may be constructed of an.
electrically conductive material ardor coated with an electrically conductive material, Optionally, n .icroneedles may be coated with. an electrically conductive material and constructed of a no=r-conductive material. Mic.ronee les may be fabricated using a variety of.materials, e.g..
,metals, stainless steel, solid or coat of gold over NI, Pd or Pd-Co,. Pt, silicon, silicon dioxide, polymers glass, biocottmpatible polymers, titanium, silver, or suture materials.
Biodegradable polymers may also be used such that if a tip of a tticroneedle were, to snap or break off during insertion, it would easily biodegrade.
[01391 A microneedle array '-)34 may be constructed or fabricated using any variety of nanufircturing m=ethods known to persons of ordinary skill in the art.Mic.roneedles may be arrayed, attached, etched or deposited onto a surface of an electrode, In another variation, n .icroneedies may be etched from . or deposited onto a silicon electrode, such that the n .icroneedle patch, including electrode and microneedles, are made from one material.
215 creating a durable and stable r -~icroneedlc patch.
101401 As shown in :FIG 18, microneedles may be fabricated by creatirn micron sized holes on a silicon substrate and by using a KOH solution to create the needle shape. In other variations, the n .ic:roneedles may be made of non-conductive material but may still be utilized to provide superior anchoring properties such that a microneedle patch may effectively adhere or attache to a subject's skin.

10:1411 In certain variatiorns: n icroneedle aarra =s are fabricated by patterng i_.-' onto glass substrates and defining needle shapes by litl ogtaphy. The tips of the rieedles can be ,sharpened using reactive icon etching, Optionally, holes may be drilled:
e.g., b laser.;
through the microneedles and base substrate. Holes may be drilled off-center, but parallel to the mrric.ro.needie axis, terminating in side-openin holes along the needle shaft below the needle tip. If desired, the holes can serve as micro fluidic needle bores for iz jection or infusion of drtrggs, medicines,- insulin, proteins, naar4noparticles that would encapsulate a. drug or demonstrate the ab.iliÃ:y to deliver a virus for vaccinations, etc. to be used separately or in combination with electrical or magnetic therapy. The microneedies may also be coated with nickel by electroplating, which can increase their mechanical strength [01421 In certain variations, microneedle patches or microneedle electrode arrays are made by fabricating master structures from which replicates are molded and then made electrically active. For example, SU-S may be spun on a glass substrate bearing an array mask pattern, baked, and then exposed from the backside to from a tapered needle structure.
Microrneedies may be sharpened b ; RIE etch nh. A PDMS (polydi.armethyls loxane) or similar material mold can then be copied from the a .aster, A PM 4A
(polyniethylmetha.cr-late) n-microneedle array is formed by solvent-casti.ra.g and then released from the n-old..
[01431 To provide the arrays with electrical. toÃa.ctic~rraalitr, to 'I`i=[.'u seed layer may be deposited on the PM.MA array and patterned by excimer laser to electrically isolate adjacent rows. A Ni layer (e.g., about 15 to 30 microns or 20 to 25 microns thick.) may be electroplated on the patterned seed layer to enhance structural rigidity. A
backside electrical connection to the array may be formed by backside etching of a hole and forming an electrical connection through the hole.
[01441 In another variation, the microneedle array is arranged in a 16X 16 array (i.e., 256 needles). Each needle has a height of about 400 microns and the base diameter is about 100 microns. The pitch between microneedles can be about 250 microns. The microneedle arrays are. then. coated with metal and laser-etched to provide electrical functionality Optionally, rows of:naicroneedles can be electrically isolated from each other so that alternating rows can provide alternating electrical polarity. The arrays are also interfaced with a power source. N-ficroneedles may be made of polymer, coated with a metal, and etched to act as alternating electrodes. In certain var iatioÃi.s, the firing sequence of the rric.roneedles by rows or groups may be varied or configured to alternate.

10145 In certain variations, a microneed.le array may include one or more nlicror eedles having multiple channels. For example, a multichannel silicon microneedle, may be constructed to deliver bloactive compounds into neural or other tissue while simultaneously monitoring and star elating neurons and nerves.

0141 FIG. 19 shows a cross sectional view of the skin 10 composed of an outer stratum corneunr 13 covering the epidermis 16. `I'lh.e skin also includes the dermis 18, subcutaneous tissue/fat 1.2r and these layers cover nauscle tissue 14. As shown in FIG 19, when a microneedle patch 228 is attached to a s-uhject's skin, the microneedles .1135 pierce the outer insulating stratum corneum layer 15. The 177icroneedle patch 228 can detect current passing through a stimulated nerve, and provide a superior signal as the current detected is conducted through the microneedles 235, thereby bypassing the poorly conductive str`atu corneum layer 15 which generally encompasses the outer 10 to 15 microns of skin. In other variations, ririeroneedles 235 may be fabricated to be long enough to penetrate the stratum corneum. 15, but short. enough not to puncture nerve endings, thus reducing the risk of pain, infection or injure.
10.1.471 In certain variations, microneed.les are formed such that t bey are in direct contact with their corresponding; or overlying electrodes. For example, a microneed:le patch may include an adhesive electrode pad and may utilize a conductive gel to help hold the rlricroneedles in place to prevent shear forces from breaking car bending the rlr.icroneedles.
10148 In certain variation, as shown in FIGs, 20a-20d, a nlicroncedle patch or applicator may include multiple electrodes on a single patch or applicator, e.g., positive.
negative, and/or control or ground electrodes, where the microneedles will be grouped in multiple arrays such that they conduct to the appropriate electrode. For example, FIGS 20a and 2Ob show a single patch having positive, negative and control electrodes where a separate array of electrodes is in contact with each respective electrode, This arrangement can be created using a single patch. Alternatively, as shown in IÃ_ . 20c, t o patches may be implemented, one including the control electrode with corresponding microrreedle array and the other including the positive and negative electrodes with.
corresponding microneedle arrays, The various electrodes could be interchanged. Alternatively, as shoN.
n in FIG 20d, th-hree patches may be implemented, each havi.atg a separate electrode (control, positive, or negative) with a. corresponding naicronee:dle array. In use, in certain variations, the Control may be attached above or near hone, while the positive and./or negative electrodes may be attached above nerve or muscle.
101491 Refi rrine again to FIG. 1.2, the energy emitting system 21t) can be used to treat or prevent various conditions: e.g.. urinary incontitnence, restless leg syndrome and fecal incontinence, among others, Energy omitting system 210 includes one or more conductive coils 212 disposed within or along a housing 214, one or more sensors 216 configured to detect electrical conduction. in the target nerve or to detect muscle stimulation, and a.
controller 218 coupled to the conductive coils 212 and optionally in communication with the sensor 216. The coils 212 are configured such that .in electrical current generated by the controller ?. l.fs is passed through the coils ?12 generating a magnetic field which will stimulate a target nerve, e.g., the tibial nen e 220, a muscle or other body part containing a portion of a target new e, or any nerves branching off of a target nerve, located in proximity to the coils 212, in this particular variation, the housing 214 is in the foram ofafoot cradle, as shown in FIG, 4, however, the housing could also be in the form of aa.
flexible wrap, garment or other design suitable for use with a subject.

101.501 Referring again to FIG, 12; energy emitting system-2 10 inaa y be used to treat or prevent various conditions, e.g., urinary incontinence, restless leg syndrome or fecal incontinence. In certain v=ariations, a n ethod of using the energy emitting system 210 includes positioning a first portion of a patient's body, fbr example a foot, ankle, or leg, relative to housing 214 such that a. posterior tibial nerve 220 within the first portion of the patient's body is in proximity to one or more conductive coils 212 disposed within or along tl-ie housing. In this particular variation, a patient's :foot is positioned in a housing which is in the form of a foot cradle 2l.5. A sensor in the form of a microneedle patch 228 may optionally be positioned along a second portion of the patient's body in proximity to the posterior tibial nerve 220. In this particular variation, mic:roneedle patch 228 is attached to the patient's foot over a muscle to detect muscle stimulation. Alternatively, a patch Could be placed elsewhere on the patient, for example, on the leg in proximity to the posterior '0 tibial nerve 220 proximal to and up-stream .t:rorza coils 212. Microneedle patch 228 may be composed of one or { core microneedle arrays and one or more electrodes., as described supra.
101511 Once the patient's foot is in position and the microneedie patch 228 conductive microneedle patch) is in place, a current is passed from controller 218 through coils 212, and as a result, the coils 212 generate a magnetic field which is focused on the posterior tibial nerve 220. The magnetic. field stimulates tibial nerve 220, ,. eneratins a current that will flow along the tibial nerve 220 and spread along its length, to its sacral or pudendal nerve roots. Microneedle patch 228 detects corresponding muscle stimulation or twitching or electrical conduction through the stimulated posterior tibial new e. Upon detection, the microneedle array may conduct and transmit an electrical signal to the overlying electrode of microneedle patch 228. The signal may be trants11-aitted to controller 21 , which can be .integral or a separate controller or device, or a separate controller coupled to controller 21 . The controller can then be varied or adjusted (to adjust the current or magnetic fie 1d) based on the signal received from microneedle patch 22$ to ensure that adequate conduction of the posterior tibial nerve 2211 occurs and all adequate and accurate dosage of treatment is being received-, Although shown utilizing a sensor, it is also contemplated that the system could be used witliout a sensor.
10i521 Referring to FIG. 21, the method. of using energy emitting systtemat 210 described above with respect to 1"lU 12 may be varied such that a conductive toaicroaeedle patch 228 is placed in proximity to or proximally over the atf rent posterior tibial nerve 220 i.e., behind the partient's knee. In this position, a conductive microneedle patch.
228 detects electrical conduction through the afferent posterior tibial nerve, i.e., it detects the electrical signal traveling throng the l aster o.r tibiaal nerve back up to the brain and spinal cord or it may detect corresponding muscle stimulation. The attic oneedle patch 228 sends the signal to controller 21 R or to a separate controller coupled to controller 218. The controller can then be varied or adjusted based on the signaal received from microneedle patch 228 to ensure that adequate conduction or stimulation of the posterior tibial nerve 220 occurs and an adequate and accurate dosage of treatme.nt is being received.
1.01531 A sensor utilized in the energy emitting system 210 may be a microneedle patch 228 as described above or optionally the sensor may a sensor type known in the art (e.g..
EKG sensor) or as described in any of the variations herein. It is also contemplated that energy emitting systern 250 can be utilized w thout a sensor. Optionally, the sensor ray be positioned within or along the housing, e.g., the loot cradle, along with the one or more conductive coils, or positioned at a site distant from the housing or conductive coils.
101541 In certain variations, energy emitting system. 1 t3 s ty optionall include one or more conductive microneedle patches which can be positioned in proximity to the target nerve or rt. uscle and provide an additional or supplemental electrical or magnetic stimulus to the target nerve or muscle.
101551 Referring to 1' lt= . 22,the energy emitting system. 21.0 described above with respect to FIG 12 may be varied to create energy emitting system 260. Energy emitting system 260 further includes one or more percutaneous electrode .needles 262 or other needles or other percutaneous electrodes coupled to a controller 21 Sand having an end insertable into a su ject's body in proximity to said target nerve or stimulation site. The percutaneous electrode needle 262 is inductively coupled to one or more conductive coils 212, In use, a first portion of a patient's body,7 for example afoot., ankle, or leg, is 1.1 positioned relative to housing 214, e.g.; foot cradle 215, such that a target nerve.e.g., posterior tibial nerve 220, located within the first portion of the patient's body is in proximity to one or more conductive coils 21.2 disposed within or along the housing 214.
Conductive coils 212 are Positioned proximate, optionally down-stream or distal to, a.
selected stimulation site 2611. The pereutaneous electrode needle 262 is inserted through the skin at a location and to a depth that brings the tip in close proximity to the stimulation site or target nerve to be stimulated. The controller-'! 18 is activated and a current passes through conductive, coils 212, The resulting magnetic field ,enerates a current that traverses the internal stimulation site 261 by passing. from conductive coils 212 to the internal percutaneous electrode needle 2621, as indicated by arrow 1, Also, the percutaneous electrode needle may be positioned within the generated magnetic field., whereby the rr at rietic. field itself generates a current in the percutaneous electrode which stimulates a target nerve or traverses an internal stimulation site. Optionally, a current may be passed from the control ler 218 th.rou4gh conductive coils 212 and/or .f=rom. the controller 218 through.
percutaneous electrode needle 2622, traversing the internal stimulation site as the current passes between the coils and needle.

3ti 101S6.I In eneu. emitting system 260, current density and stÃbseclue.a electric field intensity generated between conductive coils 212 and percutaneous electrode needle 252 is <greater than that generated bye traditional percutaneous stimulators. A
greater electric field intensity makes site location for conductive coils 212 and percutaneocas electrode needle 262 easier. l tÃrther pore, the load unpedarrce through the surface of the skin is much higher than the internal impedance, and as such, the relatively high load impedance lessens the likelihood of damage to tissue and nerves due to high current pulses.
101571 Referring again to FIG. 221. a percutaneous electrode .needle fir use in any of the energy emitting systems described herein may include a variety of designs. For example, percutaneous electrode needle 262 may include a metal or plastic handle 263 to provide a secure grip for the user, While minimizing the risk of shock to the user. The needle tip can have a terminal portion 2.64 which may extend between about 0.5 and. 10 nom or about 2.0 rnm from the needle tip and may be constructed out of medical grade stainless steel or other biocompaÃible metals. The diameter of the needle can be small (less than about 0.25 rr:un) which minimizes trauma during insertion. Optionally, needle 262 can be coated with. Teflon or similar Ãnsulative material 265 except for an exposed. tip area 264. This allows for a higher field density at the tip for more precise operation. The exposed .needle tip area 264 should have a sufficiently large surface area so as not to create too high a local current fie I'd tl-rat may cause irritation or pain.
[01581 In another variation, as shown in FIG. 23, percutaneous electrode needle 272.
may be used in energy emitting system 260. Percutaneous electrode needle 272 rnaay be constructed out of medical grade stainless steel or other biocompatible electrically conductive metal.. Percutaneous electrode needle 272 includes a first end 276 for insertion into the patient's body in proximity to the preselected internal stimulation site or tar et nerve to be stimulated, and a second end 277. The size of the needle electrode 272 is preferably small, for example 34G needle electrode (0,22x 10 mm), to minimize trauma durinc, insertion. Percuttai.eous electrode needle 272 may also include an electrically conductive ad.apto.r. e.g., an electrically conductive tape member 273. The tape member 273 includes an electrically conductive adhesive portion 274 aand an electrically conductive non-adhesive po.rtion2175. Alterrnatively, the adalitor may include an electrically conductive clip- The second end 277 of the needle electrode 272 preferably includes an enlarged portion to enable tEre electricrill conductive tape member 273 to be more easily adhered thereto, Once it is determined that the percutaneous needle electrode 272 is properly positioned, the ricedle is fixedly adhered to the electrically conductive tape member 273 by folding the ends of the adhesive portion 274 of the electrically conductive tape member 272 over the second end 277 of the needle electrode thereby forming an electrical connection there between. The percutaneous needle electrode 2721 is electrically coupled to controller 2.18 via electric-ally conductive tape member 273. Various other implantable or insertable electrode needles known to persons of skill in the art may also be utilized in the above described systems.
104.591 In certain. variations of energy emitting system. 260 as described above and shown in. FIGS. 22-2 3, a seÃ.asor 216, such as a conductive mic.roneedle patch 22$, maybe utilized to detect electrical conduction through the stimulated. posterior tibial nerve 220 or to detect à uscl.e stimulation, and transmit the signal to controller-118- The signal rimy be transmitted to controller 218, a separate controller or device, or a separate controller coupled to controller 21.8. The controller can then be varied or adjusted based on the signal from microneedle patch 228 to ensure that adequate conduction of the posterior tibial nerve 220 occurs and an adequate and accurate dosage of treatment is being received. It is also contemplated that energy system 260 may be utilized without a sensor 216, see for example FIGS. 24-25. Optionally, other types of sensors may be used in place of a microniedl.e patch sensor, such as other sensors described herein and sensors l.arown to persons of ordinary skill in the art, The sensor may be placed over a portion of the subject's body saris al?le.f sr detect Ãt conduction of the target nerve (e.g.. on the leg, as -shown) or over a muscle to detect muscle stimulation resulting from stimulating the target nerve.
104.601 In certain. variations, as shown in f HG=r. 26, art energy emitting system 1450 for providing a nnedical therapy includes a .microneedle patch 252 (e.g., conductive roicroneedle 215 patch) having one or :a?roue a nicro:needle arrays deposited on a surface of one or more electrodes: one or more sensors 221 configured to detect electrical conduction in the target nerve or to detect muscle stimulation: and a controller 2 1S coupled to microneedle patch 2252 and in cornrmraricatio.n with sensor .22 .1 . The microneedie patch 252 .is con gur-ed such that an electrical current generated by the controller 218 is passed through the microneedle patch 252, generating a ma4gnetic field or delÃ.veri.ng, or generating an electrical or Magnetic stimulus to a tat get nerve, e.g.,. the tibial nerve 220, a muscle or other body pat. containing a 3$

portion of a target nerve, or any nerves branching off of a target nerve, located in proximity to rmrricroneedle patch 252.
101611 Referring to.F C= . 26, a method of using the energy emitting system 250 .rna y include placing a. conductive microneedle patch 252 on a first portion of a patient's body, for example a foot, ankle, or leg, in proximity to posterior tibial .nerve '220 within the first portion of the patient's body. Sensor 221 is positioned along a second portion of the patient's body, in proximity to the posterior tibial nerve 2201 ri. tl.ii.s particular variaat.iorr., sensor 2 16 is attached to the patient's leg in p.roxr.rrl.ity to the posterior tibial new--e 220, proximal to and up-stream from conductive micr-oneedle patch 252. Conductive microneedle patch 252 is composed of one or more ..microneedle arrays and one or more electrodes, as described in the variations above.
[01621 Once conductive microneedle patch 252 and sensor 221 are in position, a current is passed from controller'-2 l' 8 through conductive microneedle patch 252, resulting in an electrical stimulus of the posterior tibial. nerve 220. Alternatively, the n'ric.ronecdle array 1.5 may be insulated or constructed of non conductive Ãnateriaal such that the microneedle patch 252 generates a r ragnetic field that stimulates tibial nerve 220 in a manner similar to the one or more coils described in the variations above, without an electrical stirrmulus. Whether the stimulus is electrical or razagnetic, either stimulus will generate a current that will flow along the tibial nere e 22 () and spread along its length, to .its sacral or pudendal. nerve roots. Sensor 221 detects electrical conduction through the stimulated posterior tibial nerve 220, and then trarrrs.rtr.its the signarl to control.le:r 2i In certain variations, the sensor may be in the form of a. n icroneed.le patch sensor. The signal may be transmitted to controller 218, a separate controller or device, or a separate controller coupled to controller 218. The controller can.
then be varied or adjusted based on the signal from sensor 221 to ensure that adequate conduction of the posterior tibial nerve 220 occurs and an adequate and accurate dosage of treatment is being received.
101631 The sensor utilized in the energy, emitting system 2 50 may be a sensor of the type described above, with respect to other variations. Optionally, for example, the sensor may be a niicroneedle patch. It is also contemplated that energy emitting system 250 can be 3 Ã) Utilized without a sensor. The sensor may be placed over a portion of the subject's body suitable for detectint, conduction of the target nerve .,te 4~. on the leg as shoo n) or over a muscle to detect muscle stimulation resulting from stimulating the target.
nerve.
101641 In certain variations, energy emitting syrstem 250 my optionally include one or more conductive coils disposed within or along a housing which can be positioned in proximity to the target a .e.rve or muscle and provide an additional or supplemental stimulation of the target nerve or muscle.
01651 Referring to FIG, 27, the energy emitting system 250 described above with respect to F iG. 26 may be varied to create energy emitting system 280.
Energy= emitting system 2,90 further includes one or more perccataneous electrode needles 262 coupled. to a controller 218 and having an end insertable into a snib-jectis body in proximity to said target nerve. Optionally, the electrode needle may be non-percuttaneous, such that it is insertable in an orifice or opening in the subject, such as a. natural orifice- The percutaneous electrode needle 262 is inductively coupled to conductive a aicroneedle patch 252. In use, a n .icroneedle patch 252.1s placed on a first potion of a patient's body, .tfor example a. foot, ankle, or leg, in proximity to posterior tibial nerve 220 within the first portion of the patient's body and down-stream or distal to a selected. stimulation site 261..
The perciatanec us electrode needle 262 is inserted through the skin at a location and to a depth that brings the tip in close proximity to the target nerve to be stimulated.
[01661 The controller 2I is activated and a current passes through microneedle patch 252 and traverses the internal stimulation site 261 by passing from microneedle patch 252 to the interrnal percutaneous electrode needle 2.62, as indicated by arrow i. The current passing through microneedle patch 252 may also generate a magnetic field which can generate a current that traverses the internal stimulation site 261 by passing from microneedle patch 252 to the internal percutaneous electrode needle 262. Also, the percutaneous electrode needle may be positioned within. the generated magnetic field, whereby the magnetic field.
generates a current in the percutaneous electrode which stimulates a target nerve and traverses an intern.a.l stimulation site. Optionally, a current may be passed from the controller 218 through ra .icroneedie patch 252 and,/or from the controller 218 throngg -z percutaneous electrode needle 2622, traversing the internal stimulation site as the current passes between the patch and needle.

[01671 Referring to FIG, 228, eneruy ernit:tirt system 280 maybe modified by using percrrtaneous electrode needle 272 in place of percutaneous electrode needle 262.
PercutaneotÃs electrode needle 272 would be constructed and function as described above with respect to FIG. 23. Various other implantable or insertable electrode needles known to persons of skill in the art may also be utilized in the above described systems. Additionally, energy emitting system 280 may utilize a sensor to detect electrical conduction throu.4 file stimulated posterior tibial nerve 220 and send a corresponding signal indicative of the detected conduction to controller 218 or other device such that the electrical of magnetic stimulus can be adjusted as :nc cessarv. The sensor may be a sensor 221, or optionally the sensor may be a microrreedle patch, it is also contemplated that energy emitting system 280 can be utilized without a sensor. The sensor maybe placed over a portion ofthe suu ject's body suitable for detecting conduction. of the target nerve on the leg as -shown) or over a. Ã usc.le. to detect muscle stimulation resulting from stimulating the target nerve , 04.68I In any of the above systems, variations are contemplated where the sensor are also coupled or connected to or other vise in communication with energy emitting devices, e.g., the conductive coils or conductive r r.icroneedle patches.
10169 In certain variations, the one or more .m.icroneedles of the microneedle patch may include an electrical1 conductive material such that the rrr_icroneedles may transmit an electrical signal to an overlying electrode or other surface. :Microneed es may be constructed of an electrically conductive material and/or coated with an electrically conductive mate.Ã-i rl. Optionally, r ricroneedle_s may be coated with an electrically conductive material and constructed of a non-conductive material.
Microneed.les may be fabricated using a variety of materials, e.g., mneals, stainless steel, solid or coat. of gold over NL 1'd or Pd-Co 11-t, silicon, silicon dioxide, polvi ergs, glass, bioconmpat:
ble polymers, titanium, silver, or suture materials. Biodegradable polymers may also be used such that if a tip of a microneedle were to snap or break off during insertion, it would easily biodegrade.
Optionally, the mic.roneedle patch may be nonconductive, 104.701 In certain var.iatio.ns, an electrode patch for improved conductance or conduction is provided. The patch can include at least one electrode having a first surface and/or a second surface. The electrode may optionally be attached to various other materials or adhesive materials. An array of microneedles may, be deposited on a surface of the electrode, or attached to apatch or other material and indirectly or directly connected to the electrode. The array of rnicroneedles may include a conductive rnaÃerial. Such patches raaay be used as a sensor to detect muscle stimulation or electrical conduction, or to provide or deliver an electrical. stimulus or mag=netic field, e.g., to a target nerve, and may optionally be used in. any of the variations described herein or i n any application where improved conductance or conduction is desired. Microneedles yield improved reduction in impedance compared to simple abrasion and other techniques, and are less painful and more comfortable for the patient.
104.711 In certain, variations, typical voltage sensed at the skin and detectable or conductible by a microneedle patch or microneedle array may ra-rige from about I to 400 microvolts or about 10 to 300 microvolts.
[01721 in certain variations, methods of treating; a sarlaje.ct with urinary incontinence or-va:rious pelvic floor disorders utilizing the energy emitting systems described herein are contemplated. Symptoms associated with urinary incontinence.Ãraa = be Observed, detected, or diagnosed. An energy emitting device having one or more energy generators, e.g., one or more conductive coils or one or more microneedle patches, may be positioned in proximity to a target nerve, e.g.., the tibial or posterior tibial nerve or popliteal or sacral nerve or branches thereof Ãifa subject or patient along a first portion of a subject's or patient's body.
The sa bject may or may not be exhibiting symptoms associated with urinary incontinence.
In the case of the conductive coils, the coils may be positioned within or along a housing, such tas a foot or knee cradle, and a foot or leg may be positioned tlac rein.
In the case of a a icrone.edle patch, the patch may be attached to a subject's skin.
Optionally, the method involves positioning a first portion of a subject's body, the subject exhibiting symptonms associated with urinary .incontinence, relative to an energy emitting device such that a target nerve within the first portion of the body is in proximity to at least one energy, generator disposed within or along the energy emitting device.
101731 A current is then passed through the energy generator to produce, generate or deliver energy, e.g.., a magnetic: or electromagnetic field or electrical or magnetic energy or stimulus, focused on the tibial or posterior tibial nerve or branches thereof.
This in turn may cause the. stimulation of a pudendal. nerve, sacral. ple is, or other nerves in the pelvic floor.
Various nerves innervating the various muscles, sphincters, nerves, organs and conduits of tl-ie urinary tract and bladder may be stimulated directly orindirectly. In certain ari:atioras, a c urrent is passed through one more coils, which generate a magnetic or electromagnetic field which stimulates the posterior tibial .nerve. In certain variations, the positioning of the coils relative to the first portion of the subject's body may be adjusted to re-focus the magnetic.
feld on the posterior tibial nerve as needed. In certain variations, a current is passed through a microneedle patch generating or delivering an electrical or magnetic stimulus or field. The positioning of the nicroneedle patch relative to the first portion of the subject's body may be adjusted to 're-focus the electrical or magnetic stimulus or field on the posterior tibial. nerve as needed.
1.01741 Optionally, electrical conduction through the target ne.rv e, e.g., the posterior tibial. nerve, or muscle stimulation can be detected via at least one sensor.
A conductive sensor may be positioned in proximity to the posterior tibial nerve along a second portion of the subject's body. Optionally, a sensor may be positioned. over a corresponding muscle to detect muscle stimulation or twitching resulting from nerve stit elation.
Optionally, the electrical. conduction is detected along a second portion of the subject's body which is different from the first portion of the body. Optionally, the sensor in the form of a microneedle patch. In certain variations, the sensor may be positioned behind a subject's knee to detect the. electrical conduction along the afferent posterior tibial nerve or on another portion of a patient's leg or foot. In other variations, the sensor may be positioned within, or along a housing along with the one or more conductive coils.
101751 Where a sensor is used, a signal is received l om the sensors and the signal.. s indicative of the electrical conduction of the target nerve, e.g.. posterior tibial nerve. The current may be adjusted or varied using a controller which is in communication with the energy generator. -Ldjustments may be made is respo se to the nerve or muscle stimulation 215 detected by the conductive sensor, in order to optimize or ensure adequate treatment of urinary incontinence by achieving the appropriate level of conductance and appropriate level of nerve or muscle stimulation. Appropriate levels or parameters for current, frequency, n agnetic field, treatment duration, etc., are those that result. in an observed or detected reduction or prevention of symptoms associated with urinary incontinence.
Treatment could also be administered and the appropriate levels and parameters achieved through observing or detecting reduction or prevention of symptoms where a sensor is not used.
Examples of these symptoms y include but are not limited to the inability to control urinary function, urinary leakage, and loss of bladder control.
101761 In certain variations, the amplitude, fi quency, direction of a generated nvapletic field, electrical or :magnetic stimulus, or firing sequence of the. coils or microneedles making up the micro needle array may he adjusted. Optionally, the current may. be varied according to a muscular response in the patient, '17hus, to treat urinary incontinence, the magnetic field or electrical stimulus is applied to a subject or patient until the desired effects {e. .., reduction of symptoms) are achieved.

104.771 In certain variations, methods of treating, a subject with fecal.
incontinence utilizing the energy emitting systems described herein are, contemplated.
Symptoms associated with fecal incontinence may be observed, detected, or diagnosed, An energy emnittins device ha s in s one or .tun.rc energy generators, e:.g., one or nacre conductive coils or one or more microneedle patches, may he positioned in proximity to a target ne.r e, e,g., the tibial or posterior tibial. nerve, or popliteal or sacral nerve or branches thereof, of a subject along a first portion of a subject's body. The subject Ãrmay or may not he exhibiting symptoms associated with fecal incontinence. In the case of the Conductive Coils, the coils may be positioned within or along a housing, such as a foot or knee cradle, and a foot or leg may he positioned therein. In the case of a m.icroneedle patch, the patch. may be attached to a subject's spin. Optionally, the method involves positioning a :first portion of a subject's body, the subjecà exhibiting symptoms associated with fecal incontinence, relative to an energy eraritting device such that a target nerve within, the Ãrst portion of the body is in proximity to at least one energy generator disposed within or along the energy emitting device.
101781 A current is then passed through the energy generator to produce, generate or 215 deliver energy`,. e_g., a magnetic or electromagnetic field or electrical or magnetic energy or stimulus, focused on the tibial or posterior tibial nerve or branches thereof`, ']'his in turn causes the stimulation of a pudendal nerve, sacral plexus., or nerves in the pelvic floor.
Various nerves innervating the vaa.ioars muscles, sphincters, rectrrrrr, nerves, organs raid conduits associated with bowel nmovements, fecal control, and the intestines may, be stimulated directly or .ind.irectly. Optionally, a current is passed through one more coils, which generate a magnetic or electromagnetic field which stimulates the posterior tibial nerve. In certain variations, the positioning of the coils relative to the first portion of the subjec=t's body may be adjusted to re-focus the magnetic field on the posterior tibial nerve as needed, In certain variations, a current is passed through a micro-needle patch ,:e-nerating or delivering an electrical or magnetic stimulus or field. The positioning of the inicroneedle patch relative to the first portion. oftlte subject's body may be adjusted to re-focus the electrical. or magnetic stimulus or field on the posterior tibial nerve as needed.
01791 Optionally, electrical conduction through the target nerve, e.g., the posterior tibial nerve, or muscle stimulation can be detected via at least. one sensor... conductive sensor may be positioned in. proxirrmrity to the posterior tibial. nerve along a second portion of the srtlaject"s body. Optionally, a sensor may be positioned over a corresponding muscle to detect muscle stimulation or twitching resulting from nerve stimulation.
Optionally, the electrical conduction. is detected along a second portion of the subject's body which is different from the first portion of the body. Optionally, the sensor is in the form a of a nr.icroneedle patch. .1.11 certain variations, the sensor may be positioned behind a subject's knee to detect the electrical conduction along. the afferent posterior tibial nerve or on another portion of a patient's leg or foot. In other variations, the sensor may be positioned within or along a housing along with the one or more conductive coils.
10.1.801 Where a sensor is used, a signal is received from the sensors and the signal is indicative of the electrical conduction of the target nerve, e.g., posterior tibia[ nerve. The current may be adjusted or varied using a controller which is in communication with the energy generator. Adjustments may be made in response to the nerve or muscle stimulation detected by the conductive, sensor, in order to optimize or ensure adequate treatment of fecal incontinence by achieving the appropriate level of conductance and appropriate level of nerve or muscle stimulation. Appropriate levels or parameters for current, frequency, 215 magnetic field, treatment duration, etc., are those that result in an observed or detected.
reduction or prevention of symptoms associated with fecal incontinence.
Treatment could also be administered and the appropriate levels and parameters achieved, through observing or detecting red-action or prevention of symptoms where a sensor is not used.
Examples of these symptoms include but are not limited: the loss of voluntary control to retain stool in the rectum; loss of fecal control inability to control bowel movements, and fecal. leaking:

t0:18l1 In certain variations, the amplitude, frequency, direction of a ggenezated magnetic .
-field, electrical or magnetic stirnuiltas, or firing sequence of the coils or nucroneedle.s making up the microneedle array may be adjusted. Optionally, the current may be varied according to a muscular response in the patient. .1-hus, to treat fecal incontinence, the ma#gnetic. field or electrical. stimulus is applied to a subject or patient until the desired effects reduction of symptoms) are achieved.
082 In certain variations, methods of treating a subject with restless leg syndrome utilizing the energy emitting systems described het eta are contemplated.
Victims afficted with Restless Leg Syndrome (RLS or Mom's syndrome), are unable to rernain seated or to stand still. Activities that require maintaining .motor rest and limited cognitive stimulation, such as transportation, e.g., in a car; plane, train, etc., or attending longer meetings, lectures, movies or other per.foraraaaraces, become difficult if not impossible. These sensations become more severe at night and RLS patients find sleep to be virtually impossible, adding to the diminishing quality of their lives. The urge to move, which, increases over periods of rest, can be completely dissipated by movement, such as walking. However, once movement ceases, symptoms return with increased intensity. If an BLS patient is forced to lie still, symptoms will continue to build like a loaded spring and, eventually, the legs will involuntary, move, relieving symptoms immediately.
[01831 Thus, symptoms associated with restless leg syndrome may be observed, detected, or diagnosed. An energy emitting device having one or more energy generators, e.g., one or more conductive coils or one or more microneedle patches,.Ãrmaay be positioned in proximity to a target nerve, e. g-, the tibia]or posterior tibial nerve, or popliteal or sacral nerve or branches thereof or other nerves associated with restless lei, syndrome, of a subject along a first portion of a subject's body. The subject mray: or Wray not be exhibiting symptoms associated with restless leg syndrome, In the case of the conductive coils, the coils may be positioned within or along a housing, such as afoot or knee cradle, and afoot or leg may be positioned therein. In the case of a microneedle patch, the patch may be attached to a. subject's s kin_ Optionally, the method involves positioning a first portion of a subject's body, the subject exhibiting symptoms associated with restless leg syndrome, relative to an energy emitting device such that a target nerve within the first portion of the body is in proximity to at least one energy generator disposed within or along the e ier:gz emitting device.

101841 A current is then passed through the energy generator to prodLice, generate or deliver energy, eg., a magnetic field or electrical or magnetic energy or stiraatrlts, focused on the tibial or posterior tibial nerve or branches thereof or other nerves associated with restless leg syndrome. This in turn car ses the stimulation of a pudendal nerve, sacral plexus or other nerves innervating the pelvic floor or various muscles, nerves, or organs associated with restless leg syndrome. The various nerves may stimulated directly or indirectly.
Optionally, a current is passed through one more coils, which generates a magnetic or electromagnetic field which stimulates the posterior tibial .ne.r-ve. In certain variations, the positioning of the coils relative to the first portion of the subject's body may be adjusted to re-.tc ctts the naa ;netic field on the posterior tibial nerve as needed. In certai.rt. variations, a current is passed through a microneedle patch generating or delivering an electrical or magnetic stimulus or field. The positioning of the nr.icroneedle patch .relative to the first 1.1 portion of the subject's body may be adjusted to re-focus the electrical or magnetic stimulus or field on the posterior tibicl, nerves as needed.
10185 Optionally, electrical conduction through the target nerve, e.g., the posterior tibial. nerve, or muscle stimulation can be detected via at. least one sensor.
A conductive sensor may be positioned in proximity to the posterior tibial nerve along a second portion of the subject's body. Optionally, a sensor may be positioned over a corresponding muscle to detect muscle stimulation or twitching resulting, from nerve stimulation.
Optionally, the electrical conduction is detected along a second portion of the subject's body which is different from the first portion of the body. (=Optionally, the sensor in the form a of a nr.icroneedle patch. In certain variations, the sensor may be positioned behind a subject's knee to detect the electrical. conduction along the afferent posterior tibial nerve or on another portion of a patient's leg or foot. In other variations, the sensor way be positioned within or along a housing along with the one or more conductive coils.
101861 Where a sensor is used, a signal is received from the sensors and the signal is indicative of the electrical conduction of the target nerve, e.g., posterior tibia! ner e. The current may be adjusted or varied using a controller which is in communication with the energy generator. Adjustments may be made in response to the nerve or muscle stimulation detected by the conductive sensor., in order to o- ti.mize or ensure adequate treatment of restless leg syndrome by achieving the appropriate level of conductance and appropriate level of nerve or muscle stÃinalatÃon. Appropriate levels or parameters for current, frequency, magnetic field, treatment duration, etc., are those that result in an observed or detected reduction or prevention of symptoms associated with restless leg syaadrome.
Treatment could also be administered and the appropriate levels and parameters achieved through observing or detecting reduction or prevention of symptoms where a.
sensor is not used. Examples of these symptoms include but are not limited to: uncomfortable sensations in. the limbs, irresistible urges to move, usually the legs; motor restlessness; when tart rest, symptoms return or worsen; and symptoms worsen in the evening and at night.
[01$71 in certain variations, the amplitude, frequency, direction of a generated magnetic field, electrical or magnetic stimulus, or firing sequence of the coils or r:ra.icroneedle s making rap the r ricroneedle array may be adjusted. Optionally, the current may be varied according to a muscular response in the pa bent. Thus, to treat restless leg yn dronie, the magnetic field or electrical stimulus is applied to a subject or patient until the desired effects (e.g., reduction of syrrrptor as) area achieved.
101881 In certain variations, methods of treating a subject suffering from premature ejaculation or Various pelvic floor disorders utilizing the energy emitting systems described.
herein are contemplated. Symptoms associated with premature ejaculation may be observed, detected, or diagnosed. An energy, emitting device having one or more energy generators, e.g., one or more conductive coils or one or more m .c `oneed.le patches, may be positioned in proximity to a target nerve, e.g., the tibia] or posterior tibial nerve or popliteal crr sac.ra;l ne.r e or branches 1lrereofof a seal jest alcrrrg a first portirrrr of a subje is irodz , The subject may or may not be exhibiting symptoms associated with premature ejaculation. In 215 the case of the conductive coils, the coils may be positioned within. or along a housing, such as a foot or knee cradle, and a foot or leg may be positioned therein. 1n the case of a rrricroneedle patch, the patch may be attached to a. subject's skin.
Optionally, the method involves positioning a first portion of a subject's body, the subject exhibiting symptoms associated with premature ejaculation, relative to an energy emitting device such that a.
target. nerve within the t rst.laortion of the body is in proximity to at least one energy ,generator disposed within or along the energy emitting device.

4$

10189.1 A current is then passed through the energy generator to produce, generate or deliver energy,, e_n.r a magnetic or electromagnetic field or electrical or magnetic. energy or stimulus, focused on the tibial or posterior tibial nerve or branches thereof.
't'his in turn. rna cause the stimulation of a pudendal nerve, sacral plexus, or other nerves in the pelvic floor or nerves associated with the control of ejaculation. Various nerves innervating the various muscles. sphincters, nerves, Organs and conduits of the urinary tract, bladder or reproductive systern., or pelvic floor may be stimulated directly or indirectly.
Optionally, a current is passed through one more coils, which generates a magnetic or electromagnetic field which stimulates the posterior tibial nerve. In certain variations, the positioning of the coils relative to the first portion of the subject's body may be adjusted to .re-focus the magnetic field on the posterior tibial nerve as need.ed. In certain variations, a current is passed through a rz .icroneedle patch generating or delivering al electrical or magnetic stin-11uulus or field. The positioning of the microneedle patch relative to the first portion of the subject''s body may be ac ju.sted to re-focus the electrical or magnetic stimulus or field on the posterior tibial nerve as needed.
[01901 OptionallV, electrical conduction through the target ner-v , e.g., the posterior tibial nerve, or muscle stimulation can be detected via at least one sensor.A
conductive sensor mays be positioned M. proximity to the posterior tibial. nerve along a second portion of the sul ject's body. Optionally, a sensor may be positioned over a corresponding imiscle to detect muscle stimulation or twitching resulting from nerve stimulation.
Optionally, the electrical conduction. is detected along à second portion of the subject's body whIch is different from the first portion of the body. Optionally, the sensor in the form of a microneedie patch. In certain variations, the sensor may. be positioned behind a subject's knee to detect the electrical conduction along the afferent posterior tibia!
nerve or on another 215 portion of a patient's leg or foot. In other variations, the sensor may be positioned within or along a housing along with the one or more conductive coils.
101911 Where a sensor is used, a signal is received from the sensors and the signal is indicative of the electrical conduction of the posterior tibial nerNe. The current may be adjusted or varied usin g a controller which is in co communication with the energy ;generator.
Adjustr.rrent:s may be made .in response to the nerve or muscle stimulation detected by the conductive sensor, in order to optimize or ensure adequate treatment of premature ejaculation by ach. evi ng the appropriate level of conductance and appropriate level of nerve or muscle stimtalation. Appropriate levels fear current, frequency, magnetic field, treatment duration, etc., are levels that result in an observed or detected reduction or prevention of symptoms associated with premature ejaculation. Treatment could also be administered and the appropriate levels and parameters achieved through observing or detecting reduction or prevention of symptoms where a sensor is not used. Examples of these symptoms include but are not limited to. ejacÃulation that frequently occurs within one minute or loss of penetration; the inability to delay ejaculation on penetrations; or persistent or recurrent ejaculation with minimal stimulation before, on or shortly after penetration.
1'01921 In certain variations, the amplitude, .frequency, direction of a generated magnetic field, electrical or magnetic sÃimultrs, or firing sequence of the coils or microneedles making up the inicroneedle array may be adjusted. Optionally, the current may be varied according to a muscular response in the patient. Thus, to treat premature e_jactrlation, the magnetic field or electrical stimulus is applied to a subject or patient until the desired effects (e.g,, reduction of symptoms) are achieved.
[01931 Exemplary treatment parameters for treating various conditions, e.g., tnuinar y incontinence, using the systems and n :ethods described herein may .include the fol lowving.
Operation of a conductive coil at about. 10 to 20 hertz generating a magnetic field of about .25 to 1.5 testa., where the coil is administered to a patient for a duration of about 30 minutes:/day or 30 minutes per week, depending on the severity of the symptoms, until the symptoms subside. The above treatment parameters or. variations 011 the Parameters may be used for treatment of urinary incontinence, fecal incontinence, restless leg syndrome, or premature ejaacul.a.tio r or other conditions. For example, the coil may be operated at various parameter ranges falling with the following ran4ges: about 5 to 100 hertz, about I to 10 testa..
for about 15 minutes to -2 hours per clay or week. In treating premature ejaculation, a patient may receive treatment about 4 to 10 hours prior to intercourse. A maintenance phase of tr-eaatment, after the initial treatment, may vary for various conditions. For example, the maintenance phase may require application of the systems and m ethos s described herein at the parameters described herein for 30 minutes;'weels or 30 mintrtes"'mont a..Any treatment parameter may be varied or modified based on the effect on the patient or sensor or patient feedback: regarding slim ulatioat., until the desired res-ul:t of treating or preventing a condition is achieved.
101941 hi certain variations, as shown in FIGS 29a-29d, energy emitting device may include a controller 289 and a foot cradle 290. Foot cradle 290 may include vertical foot plate 29.1, and :hori !ontal foot plate 292, where each plate can. be ad tasted using vertical foot plate knob 293 and horizontal foot plate knob 294. One or more MG plugs 295 are provided. An air core coil 297 or other type of coil is provided. A display screen 29Ã may also be provided along with power cord 298. The display screen 296 can display= a variety of information to the user and/or practitioner such as the level of power or current applied, treatment time, temperature of the cradle device, detected current levels aid/or physiological parameters, etc., to facilitate effective and efficient therapeutic treatment.
The information can be used to vary or adjust the controller to ensure that adequate conduction of a target new e. e.g., posterior tibial nerve 220 or muscle stimulation occurs and aan adequate and accurate dosage of treatment is being received. Controls may also be included to affect the 1.1 following: power, field strength, frequency.
pulse, start paaase and caatacelatiran of therapy (as shown) or other parameters one of skill in the art would. find necessary or useful to control or monitor. 1.n certain variations, a sensor may be connected, connected or in corn-nmrara.icdtion with the fbot cradle or other energy er ittirtg apparatus, controller, housing conductive coils, or r ucroneedle patch.
[0195] In certain v ~ariaations, as shown in FIGS 30A-30B, an energy emitting device may include a controller and a knee support or knee cradle. The cradle may be configured to provide the conductive coil in proximity to the popliteal fossa or area directly behind the knee. In certain variations, the knee cradle may be configured to cradle or surround at least a portion of the knee or substantially the entire knee without placing direct pressure on the popliteal fossa, thereby minimizing or avoiding venous thrombosis. In one variation, the device may be utilized while the knee is in the flexed position (Fig. 30A). in another variation, the device may be utilized while the knee is in a non-flexed position (Fig. 3013).
104.961 In certain variations, the energy emitting device, eg., foot support or cradle, knee support or cradle, etc., includes a conductive coil positioned such that a target nerve is automatically targeted. The conductive coil is configured, sized and positioned within the device such that the generated magnetic field. may encompass and stimulate the target nerve in any patient based on the target nerve7s anatomical location, thus providing automatic targeting of the nerve in any patient. once the patient laositions a pa.rticula.r bod. y portion in the device.
101971 In certain variations described herein. sensors may detect voltage or current and may be connected, coupled, wirelessly connected or coupled or otherwise in con-munication with housing, conductive coils, microneedle patch, energy emitting apparatus, energy generators, or electrode needles and/or controller using a vane", of methods or tecimiqu:es known in the art. In various variations described herein, housings, conductive coils, m.icroneedle patches, energy emitting apparatus, energy generators, or electrode needles may be connected, coupled, wirelessly connected or coupled or otherwise in communication with each other, controllers or sensors, using a variety of methods or techniques known in the art.
101981 Coils used in any of the variations described herein, and illustrated in the corresponding figures may take on a variety of shapes, sizes, and configurations, 'For example, a coil .may be shaped as a spiral (as shown) or have a simple helical pattern or be a figure eight coil., a four leaf clover coil, a Helmholtz coilõ a modified Helmholtz coil, or may be shaped as a combination of the aforementioned coil patterns. Additionally, other coil designs beyond those mentioned hereinabove.might: be utilized as long as a magnetic field is developed that will. encompass a target nerve.
10.1991 The coils may have a variety of dimensions and cornfiguratio.Ãn.s. In certain variations, a coil may have a central aperture. The diameter of the aperture may range from about 0.5 inch to 2 inches or 1 inch to 1,5 inch s or the aperture may have a diameter of about l inch. The diameter of the coil body may vary, For example, the diameter may ranee .from about 3.0 to about 7 .inches or from about 4 to about 5 inches or the diameter may about 4.5 inches. The coil body may include any suitable number of turns.
For example, the coil body may include from about 2 to about '25 turns or from.
,about 10 to about 20 turns or 14 to 1.7 turns. The adjacent turns may be spaced apart from each other, providing a. gap there between. An end_ or cross section of a turn may have various dimensions, For example, the end or cross section may have a height that is greater than its width. An end or cross section of a turn may have a height ranging, from about I to 5 cm or from about 10 mm to 51 min (about .3 inches to 2 inches) or about 25 inm to 40 mm (about I inch to 1.5 inches) or about 12 mm to 40 mm (about .5 inch to 1.5 inch) or about .5 inch to 2 inch. The end or cross section of the turn may have a width ranging from about 0.5 r int to about 5rarn (about.019 inch to .19 inch) or from about 1 rrmr. to about 2 r rm (about .03 inch.
to.0 7 inch) or about .2 mrn to about 1.6 nrnm (about .01 inch to .06 inch).
The above are all, exemplary dimensions, where other dimensions are also contemplated depending.
on the use and configuration of a device.
1102001 In certain variations, a system or device for electromagnetic or magnetic induction therapy may include one or more conductive coils disposed within. or along an applicator. The coil may be ccrrfgured to generate an elect:romaggnetic or magnetic field focused on a target nerve, muscle or other body tissue positioned in proximity to the coil.
1Ã1 The system may also i nclude one or more sensors. The sensor may be configured to detect electrical. conduction in the target nerve or to detect stimulation of a n auscle or other body tissue. The sensor may also detect a muscular response caused by an electrical conduction in a target nerve. The, sensor provides feedback about the efficacy of the applied electromagnetic or magnetic induction therapy. Optionally, a user may provide such feedback based on detection by the user, with or without the use of a sensor.
The system may also include a controller which, is in communication with the sensor. The controller may be adjustable to vary a current through the coil in order to adjust the ma?netic field focused upon the target nerve based on feedback from the sensor or user. The various systems or devices described herein may be utilized with or without a sensor.
[0201.1 A variety of electromagnetic or magnetic induction applicators designed or configured to stimulate various portions of a patient's body for treating various conditions are contemplated herein.
102021 IFigure 3].E illustrates a variation o.{art hhand or ar.rm applicator 310. :i'lre hand or arm applicator 310 may be ergonomic or contoured to a hand or arm to be positioned relative to or in proximity to a hand or aria to generate an electron agnetic or magnetic field focused on a target nerve, muscle or other tissue within the hand or arnt.
Optionally, a hand or arm applicator 3 10 may be designed to stimulate the entire hand or arm of a patient, for example, where the patient has limited or reduced nerve innervation to those portions of the body.
3[) [(1t)3 Figure 3113 also illustrates a variation of a foot, knee or leg applicator 320. The foot, knee or leg, applicator 320 may be ergonomic or contoured to a foot, knee or leg to be positioned relative to or in proximity to a toot :knee or leg to generate an electromagnetic or magnetic field focused on a target nerve, muscle or other tissue within the foot, knee or leg.
Optionally, a foot, knee or leg applicator 320 may= be designed to stimulate the entire foot., knee or leg, of a patient, for example, where the patient has limited or reduced nerve innervation to those portions of the body.
1.02041 Figure 32 illustrates a variation of a stand alone back applicator 330. The back applicator 330 may be ergonomic or contoured to the back or to a specific.
area of the back.
to be positioned relative to or in proximity to the back to generate an electromagnetic or magnetic field f ocused on a target nerve, muscle or other tissue within the back. A back applicator 330 may be aligned along the spine or positionable .i-n proximity to the spine. The back. applicator 330 may be utilized to stimulate nerve offshoots, dorsal ganglion, the spinal cord itself or any other nerve .in the body,, to treat various conditions, for example, to treat atrophy or paralysis, 0205 The back applicator 330 may include several coils, which .rimy be pulsed mtermittend . l.r-r certain variations, a sensor raaav be placed orr. muscle .in dernt.atome to provide feedback to ensure stimulation of the proper dorsal root ganglion or vertebral body.
The sensor may provide feedback to channel energy = or current to the proper or effective coil in an applicator, e.g_, in an applicator having multiple Coils_ [02061 Figure 33 shows a system including a corded back applicator 340, a sensor 342 and a logic controller 344. Various sensors may be utilized, e.g a three lead EMO, other E s1G electrode, a microneedle electrode, or any sensor for detecting physiologic changes associated with nerve firing and:i`or muscle contraction, The sensor 342:
provides feedback which may be used to monitor and/or control therapy. The sensor 342 may be used to position or optimize therapy in a clinic or home healthcare setting. The applicator 340 may or may, not contain a pulse generator and/or logic controller circuitry.
Figure 33 shows the logic controller 344 and pulse generator as a separate unit. The logic controller may optimize therapy and minimize energy usage or overheating based on feedback from sensor 342.. Optionally, the logic controller 344 may be incorporated into an applicator. The logic controller 344, whether separate from the applicator or incorporated in the applicator, may be controlled based on feedback from the sensor.

[02071 1'i:gure 4 shows a system including a hole back applicator 350, a sensor 352 and a logic controller 354. One or more back applicators 350 may provided. One or more applicators 350 may include automated therapy tar eting. The applicators 350 may include multiple coils, which can be fired sequentially to stimulate the entire spine or chain of dorsal .root ganglion (with or without user or sensor feedback) for osteoarthritis therapy, back or neck pain therapy, prevention of muscular atrophy and/or nerve recover-y, after paralysis, stroke, or after suffering other nerve damaging conditions_ In one variation, one or more applicators 350 may include multiple coils fired sequentially in order to determine the optimal coil for stimulation. based on user or sensor feedback.. Once the optimall coil is determined, that coil may be selected and used for the remainder of the therapy. In another variation, one or more applicators may include one or more coils that are slidablee adjustable or movable within the applicator housing. The coils may be moved within the applicator housing to treat a large area and,"or to be focused on the optimal treatment zone based. on feedback from the user and/or feedback from the sensor.
1.02081 Figure 35 shows a variation of a back applicator 360 which may be positioned i.Ã .
proximity to or aligned along a spine. The back applicator 360 may have ergonomic features or may be placed in proximity to a spine or a spine may be positioned in proximity to the applicator 360. The applicator 360 may include several coils that are paused i.Ã-rtermittently. As shown in Figure ?5, the back applicator 360 or focused back applicator may me held on a patient by an ergonomic positioning element 361 g.. a belt) and may be fit such the cervical, thoracic, lumbar, sacral and/or lumbosacral curvatures hold the back applicator 360 in the optimal position. The applicator 360 mar, be located any\ There along the positioning element 361 depending on the individual and area to be stirr-rulated.
Optionally, a sensor lead ?ti`? may be placed over Musculature or along a nerve excited by activation of the applicator 360, in one variation, a coil power line 365 for supplying power or current from the logic controller 364 to coils positioned in the applicator 360 may include fluid cooling, e.g-. air or liquid cooling.
102091 Figà re 36 shows an applicator 366 designed or configured to generate a .magnetic field focused on a target nerve responsible for phantom or neuropathic pain.
The applicator 366 or phantom:, pain therapeutic stimulator unit may be utilized to treat phantom pain or neuropathic pain, to provide phantom pain or neuropathic_ pain therapy. The applicator 366 rna be ergonomic or contoured to be positioned relative to or in proximity to a nee _e responsible for phantom or netÃr=opathic pain.
102101 Figure 37 shows a facial neuralgia applicator 380. Facial .neuralgia applicator 380 may be may be ergonomic or contoured to a face or head to be positioned relative to a face or head to stimulate a nerve responsible f:or facial neuralgias. The applicator 380 may be designed or configured to be positioned relative to, in proximity to or on a patient's face or head and to generate a magnetic field f acused on nerves responsible for facial ne?uraigias, e.g., the trigerninal nerve, to treat facial neuralgia. Optionally, a sensor r .ay be positioned along a facial nerve to ensure adequate therapy and to provide feedback, e.g., to a. logic controller, regarding nerve conduction or body stimulation.
[02111 In certain variations; an applicator may be designed. to ergonomically target common nerves responsible for common neural fists in order to treat such .-r.t tr.Ã algias. In other variations, an applicator may be used for treating neuralgias virtually anywhere on a patient's body. including i.n deep ..nerves due to the ability of magnetic.f Ãelds generated by the applicator to penetrate painlessly. In certain variations, a-n applicator maybe designed to generate a magnetic field focused on a target nerve to treat central or peripheral netÃ.ralgias.
102121 Figure 38 shows a depression applicator 386 which Is desIgned or Configured to be positioned relative to, in proximity to or over a frontal. cortex. The applicator 386 may be ergonomic or contoured to a head to be positioned relative to a head to stimulate the frontal cortex. The applicator 386 may generate an electromagnetic or magnetic field focused on the frontal Cortex to treat. depression. A sensor may be positioned in the offshoots of the motor cortex. The sensor may provide feedback to ensure appropriate placement of the applicator 386 or coil. In one variation, the applicator 386 may include a therapeutic coil and r. ta.rgget:ing coil te.g, a small non-treats ent: coil), %%hi.ch. may be positioned a certain distance behind the, therapeutic coil, e.g., about 5 cm behind the therapeutic cod. When firing, of the targeting coil is sensed by the sensor (or user-feedback), the therapeutic coil may be positioned in the correct or optimal position over the frontal cortex for depressive therapy.
[02131 Figure 39 shows a migraine applicator 390 which is designed or configured to be positioned relative to, in proximity to or over an occipital. nerve. The applicator 390 may be ergonomic or contoured to a face or head to be positioned relative to a face of head to stimulate the occipital nerve. The applicator 3z generate an tflrzà ?a a? ti or magnetic field focused on the occipital nerve to halt, prevent or treat nmigraines. The applicator 390 may have an ergonomic design. to ensure appropriate placement over the occipital nerve. In one variation, the applicator 390 may be a single (or fey ) pulse device..
The applicator 390 may be in a portable format. The applicator 390 r nay also.
be without any significant cooling features. Optionally, the applicator 390 may have cooling features.
In another variation, a_n app.l cafor may be a multiple pulse, higher frequency device. Such an applicator may i.arclude cooling features, :where cooling is provided by utilizing liquids or airflow, such as rapid airflow to cool the coils or applicator.
1:02141 Figure 40 shows a variation of an applicator 396 i.n the .form of a stimulatory coil platform which may be ergonomic and contoured to a knee. The applicator 39 is configured to be positioned relative to or in proximity to a knee or the applicator 396 is configured such that a knee may be positioned relative to or in proximity to the applicator 396. The applicator 396 may be configured to generate an electromagnetic or magnetic field focused on the popliteal. nerve for peripheral nerve stimulation to treat various conditions, e.g., overactive bladder, neuropathic paint or restless legs. In one variation, a stimulatory coil. may target an area behind a patient's knee or the popliteal fossa, and the knee may be rested or? a stimulatory coil platform applicator in any position.
[02151 In certain va:riatioar.s, an applicator may include one or two (-bilateral) magnetic 210 field generating coils, which may be positioned around the knee when the patient is in a sitting, standing or prostrate position. In certain variation a pulse generator or Iog ic controller 397 may send energy through one or more coils to create an electromagnetic or magnetic .field. The applicator or coils may generate stimulatory or rion-sti.mulatory fields.
Sensor or user :feed?aack may provide feedback to logic controller to optimize therapy, e.g., with the stimulatory fields. An applicator may be utilized for generating niagnetic fields focused on. an area of a. patient's body, e.g., the knee, to treat various orthopedic indications, e.g,, knee pain or osteoarthzitÃs. An applicator may be utilized for generating magnetic fields .focused on a area of a patient's body to treat various. non-orthopedic indication?s, via, e.g., peripheral nerve stimulation, 0 [02161 Figures 30 -308, sl-iow a variation of an applicator 40 which may be utilized for popliteal nerve stimulation and/or treatment of the knee. The applicator may be designed or configured to generate an electrorna. rnet.ic. or magnetic field focused on à 7e popl.iÃeal nerve for popliteal nerve stimulation or on the knee for treating osteoarthritis, The applicator is configured to be positioned relative to or in proximity to a knee or the applicator is configured such that a knee may be positioned relative to or in proximity to the applicator. A lefg mart rest on the applicator coil or be positiorned ab ve it. Optionally, as shown in. Figure 30B, a foot rest 1.04 may be provided for holding up a foot.
02171 Figure. 41 shows a system including a. variation of an ergono: n is back applicator 410 held on a patient's body by an ergonomic pros tio.Ã ing element 411 in the fort of a shoulder harness. A sensor 412, and a logic controller 414 are also provided, The applicator 410 may include various positioning elements 411, e.g., a shoulder harness, an upper torso garment, or an ergonomic back-countered plate. The applicator 410 may be stimulatory or noa~-stiazrarlaatczry . In another variation, an applicator .amaaybe rested on a seat or chair such that a stimulatory coil reliably overlies the area of the patient's body requiring stimulation.
In certain variations, one car More coils may be -Fixed on. the applicator (requiring prior targeting by a healthcare provider or patient) or one or more coils may move freely within or along the applicator and may be locked into position when the desired, or optimal position is located. C.-oils may also move a atutoarmmatically in order to optimize.
targeting- of the coil based on sensor or user feedback. The system may be incorporated into a single unit or, as illustrated, have at least two components including a separate logic controller.
[02181 For any of the applicators described herein, such applicators May include one or more of the following features. Tae applicators naay be ergonomic or contoured to the specific region of the body or anatomy to which the applicator will be delivering stira arlati.on. The applicators may be configured or designed tai be positioned relative to, on, around, or in pro :imity to a specific re xion of the body or the applicators may be con-figured or designed such that the targeted region of the body may be positioned relative to, on, around or in proximity to the applicator. The applicaatcors may be opeÃnalble or adjustable to allow for insertion or entrance of the targeted body part or anatomy into the applicator or to allow lo.r placement of the applicator om,o (",r around the targeted body part or anatomy. The applicators may be flexible or ergonomic to accommodate nearly any type of body habitus.
In certain Variations, a solenoid-type c.o.il. Mays incorporated into an applicator for delivering :PENIF stimulation directly to the targeted areas or regions of a body. In certain variations-any of the applicators described herein may a.ppic x.i:Ã ate the respective targeted body area or anatomy or the applicators may be designed such that the body region or targeted. a nat.ortay:
may approximate the applicator.
102191 In certain variations, any of the applicators or systems described herein may be used to provide electromagnetic or magnetic induction therapy with or Without a sensor.
102201 In certain variations, electromagnetic stimulating devices or applicators for providing stinrul.ation to tissues of the ltunian. body.; including rie:rve:s, muscles (irrc lu:ding superficial and deep muscles), and/or other body tissues fors the treatment of various conditions, including, e.g., chronic and acute pain, are provided.
1.0221.1 The de-vices ma.y utilize an inductive coil encased within an ergonomic, body contoured applicator to target specific regions of the body. The coils may be designed to target peripheral nerves throughout the body that have been irraplicarted or ins cal: ed in pairs syndromes.
10221 The various designs and configuration of the deices described herein allow for easier application, more consistent therapy and home use wltile targeting anatomic regions with therapeutic pulsed electromagnetic fields. The fields may also be delivered or applied in an intermittent manner to allow for convenience and ease of use while providing a durable benefit. With intermittent external stimulation by pulsed electromagnetic or magnetic fields, a nerve or other tissues may be stimulated in manner that provides a continued and lasting effect on nerve, muscle or tissue function, without habituation.
102231 The electromagnetic or magnetic induction stimulation devices described herein substantially improve the state of the art electromagnetic stimulation technology and may incorporate the delivery of REMIT" therapy into a user friendly, body contoured applicator.
In certain variations, a delivery system :for PEM.F therapy may include elements such as, e.g., (I)an ergonomic,- body contoured applicator which provides for repetitive application and consistent therapy onto the same body area. The applicator may be coded with clear markings to facilitate repetitive and consistent therapy onto the same body area; (2) the use of a sensor to provide feedback that s irtaulatiort is occurring effectively;
and:'or (3) the use of intermittent stimulation to effectively treat various conditions, e.g..., chronic pain. without habituation. These elements individually or the various combinations of these elements have provided for an easy to use, ergp,onomicall designed system: that has applications within a host of clinical and home case. of use health applications.
102241 in certain variations, an electromagnetic or magnetic. Induction stimulation device able to provide stimulation to tissues of the human body, including nerves, muscles (i.rac.ltrdin` superficial and deep muscles), arid/or other body tissues without significant discomfort to the patient is provided. Conductive stimulating coils may be encased in an ergonona:ic, body-contoured applicator that is coded with clear markings to provide for repetitive application and consistent therapy onto the same body area. The design of the applicator allows lor- ease of use and also for the targeting of anatomic regions to be exposed to the impulses of the PEMl^s. The electromagnetic stimulating device may provide P.EMF
in a manner that is patient user friendly and the device may be portable. The device may be utilized in a hospital, an outpatient clinic, a therapist's office, or at a patient's bonne.
1025 In certain variations, an electromagnetic or magnetic induction stimulation device may stimulate .regions Of the bode to treat conditions requiring both.Ãraaximal stimulation (i.e., sufficient to cause contraction of muscle fibers and firing of nerves) as well as submaaximal stimulation (which will be sufficient to provide therapy but not to cause.
contraction of muscle fibers).
102261 The electromagnetic or magnetic induction or stimulating devices described.
herein may be utilized for various indications. The indications mays be divided into maximal and submaximal categories, in which the former requires significantly higher levels of inducting current tb.an ttlhe laatter`. The maximal application,.;.; of the device include, bin are .not limited. to., Non-invasÃve stimulation (intermittent or continuous) of the peripheral nervous system for treating chrome pain: stimulation of a nerve for the up- or down-regulation of hormones or cellular prol tern, tion; treatment and/or prevention of atrophy, which would he therapeutic during= recovery after an individual sustains a fracture, experiences paralysis of a limb or other body part, or undergoes surgery, such as .CL repair in the knee;
treatment of neurogenic or overactive bladder and bowel and stimulation of the central nervous system to alter neural pathways or up/down-regulate the aforementioned factors.
1.02271 Additional applications of the devices include but are not limited to., treatment of neuropathic pain (e.g., phantom pain in limbs or other neurologic pain) or orthopedic pain (back aild neck part or skeletal related pain,); tteatnle:Ã t of overactive bladder and ho vet and treatment of arthritis and/or orthopedic conditions.
102281 In certain variations, a device is provided for delivering PEMF
stimulation to selective anatomic regions of the body, utilizing an ergonomic applicator designed to facilitate accurate and targeted delivery of therapy. The applicator may be coded with clear or solid markings to provide for repetitive application and consistent therapy onto the sate body area of the body. This design may facilitate the. placement of the device ftbr the stimulation of key nerves, muscles, and'or body tissues.
102291 In certain. variations, a device is provided which may be utilized to electromagnetically stimulate selective nerves, muscles, and: or body, tissues, where the device is user friendly and capable of being used even by an unskilled patient in a home healtlca re settiraL.
E02301 In certain variations, a device is provided to electromagnetically stimulate selective nerves, n uscles, and body tissues to provide consistent therapy, with an ergonomic applicator tar eting key nerves and eliminating the requirement fio.r a highly trained operator to manipulate the device.
10231 In certain variations, an electromagrnetic or magnetic induction syste.nm or device may be configured or designed to provide intermittently applied pulsed magnetic fields in the treatment of chronic conditions, stach as pain. For example; a device as described herein may provide shorter. intermittent stimulation to treat chronic pain or other chronic conditions. The delivery of pulsed n magnetic fields may have a continued and lasting effect on nerve function in treating conditions, such as, overactive bladder as well as other chronic neurological and orthopedic conditions such as neuropathic pain, restless legs and orthopedic pain (e.g., spinal pain, back pain, etc.) 2 [02321 In certain variations" intermittent pulsed magnetic fields may be utilized for the treatment of chronic and acute raon-orth opedic conditions such as neeÃropat?tic pain, phantom pain and chronic neuralgias, as well chronic and acute orthopedic conditions, such as back pain . and neckpaia. The therapeutic magnetic fields may be applied frequently (e.g., several times a day) or less frequently (e.g.; once a week or once a month) depending on the durability of the effect for the individual patient. Treatment involving the use of magnetic fields does not require surgery or needles to stimulate a nerve. Also, the deliver of intern ttent pulsed magnetic fields prevents the nerve from becoming habituated to the stimulator signal by ensuring that there are periods during which the nerve is not subjected to the stimulatory signal. Accordingly, the electromagnetic or .Ã iagÃÃetic induction systet s or devices described herein :away provide unparalleled ease of use, non-invasiveness, reliability of therapy based on sensor feedback and/or ergonomic targeting, and/or a lack of habituation due to intermittent stimulation provided by certain systems and devices.
02331 In certain variations, the electromagnetic or magnetic induction systems of devices described herein may incorporate an air-cooled coil wherein the air coolant, e.g., liquid or air, is drawn through and/or in between the turns of the inductive coil, in direct contact with conductive surfaces of the coil, Drawing air or other fluid through the coil prevents the coil from heating up to the degree that could damage the coil and the electronics of a device, or expose the patient to excessive temperatures.
10341 In certain variations, the systems and devices described therein may be utilized to stimulate nerves.fo.r a variety of corndr ions, including, e.g., atrophy prevention., nerve repair/regeneration, neuromodulation, chronic pain, up or down regulation of hormones, restless legs, phantorn pain, etc. The systems and devices may also be used to stimulate muscles and/or other body tissues to accelerate tissue healing aelgeneration and/or 4 rowtlr.
tO23-51 In certain variations, the electromagnetic or magnetic induction systems or devices described herein and other implantable or extracorporeal devices may allow for the automatic adjusting of nerve, stimulation based on feedback, 10236 1.11 one:. variation, an extracorporeal or implantable device, e.g., any of the electromagnetic or magnetic induction devices described herein, a pacemaker, defibrillator, or nerve stimulator, may include a feature that allows for automatic a justment of nerve stimulation based on feedback provided by a sensor or user. This -t:eat.ure may minimize pain and. power u age while ea oring optimal therapy deli very>. A device may include a.
stimulator and a sensing coarmponent. The stimulator may be automatically adjustable based on feedback from the sensor tap to a inaximal (safe) threshold. Each therapy may start with lower powered pulses, followed by increasing power pulses until the sensor detects stimulation. The algorithm allows for the minimal amount of power to be used and allows for automatic a adjustment of power settings as conditions change.

[02371 In one variation , an i plantable device may include a sensor-, such that the device can stimulate tissue or nerves and sense stimulation it the same site. For example, the sensor may provide feedback to the implantable device r-egar-ding nerve conduction at the site of stimulation. As fibroses develops around an implant, at the site of stimulation, the feedback will. indicate whether a target nerve is nt.o longer being effect.ivel stimulated due to the fibroses, which will cause the power or level of stimulation to increase or decrease, as is neccssar r, to effectively stimulate the target site and overcome any obstruction. due to fibroses. As fibroses occurs around an implant, a patient need not report back to a physiciaÃl or other operator for adjustment of the stimulatory power of the device. The device will automatically adjust the stimulator- power or level based on sensing stimulation of the target nerve or tissue. This eliminate the guesswork involved by the user in monitoring their therapy One day at a time on their own, as they notice the effect of the therapy wear off.
This also eliminates the risk of the user being exposed to unnecessarily high power levels that might otherwise by set in order to minimize frequent return visits to a physician or 1.5 operator for adjustments.
[02381 Figures 42A and 42 show an example of how the amount ofstimttl itory power required to achieve a desired stit-nulus may be automatically adjusted as a result of fibroses, according to the above described feature. According to Figure 42:x, after the initial implant of the device, the level of stimulatory power is increased until stimulation of the target nerve or tissue is sensed (indicated by square box at, e ,g,, about 1OmV). An effective stinmulatory therapy inata ` tfncaà lae. del vexed. According to Figure 4213, after fibroses sets in, in. order to maintain the desired level of stimulation to provide an effective stimulatory therapy, the level of stimulatory power is increased until stimulation. of the target nerve or tissue is sensed (indicated by square box, e.,Y., at 20 mV). According; to the example in Figure 4213, the presence of fibroses required an increase in the stimulator power level to deliver an effective stimulatorr therapy.
102391 The automatic adjustment feature based. on sensor feedback may be utilized in any stimulator or non-stimulatory implant or extracorperal device, where the device incorporate,,, a. sensor capable of detecting the desired stimulus and a feedback loop capable ofautomatica_lly acljustin parameters (e.g., power, frequency, etc.) to ensure appropriate stimulation.

X02401 In certain variations. the electromagnetic or magnetic induction.
syztenrs oÃdevices described herein and other implantable or extracorporeal devices may incllude a feature that allows for automatic targeting of coils, 102411 A device may include multiple inductive coils or one or more movable inductive coils. The device may also include a sensor based feedback algorithm.. In one variation, the device includes a targeting or movable coil which may be positioned over or in proximity to a patient's body at a site that elicits a response that can be sensed automatically or detected by a user. Once this response is detected, the coil may either move to its stimulation position, or in the event that a small targeting coil is used, the therapeutic coil may already overlie the treatment area. Once the response is detected, the therapy may automatically begin.
[02421 in one exaa.Ãrmple, relating to the treatment of depression, the motor cortex IS
stimulated until the thumb is seen to move. The coil may then be advanced, e.g., about 5 cÃn. to about 5 inches, lo.rwaard to a position over the frontal, cortex. This f atture eliminates the guesswork that may otherkvise be involved in t aovi.ng or positioning a coil, and a automates therapy based on user feedback or EN4G senor or other sensor feedback, e.g., over aa. thumb.
102431 Figure 4.3 shows an example of a device 420 positioned on a skull. The device includes a treatment coil 4'72 and a targeting coil 423. The treatment coil 4222 .may be positioned by EMG detection with targeting coil 423 stimulation, where the targeting coil may not move.
102441 In another variation shown in Figure 43B, an ergonomic fixture or applicator 430 (e.g , a helmet) may be worn and a coil 43.2 positioned on the applicator may slide or move from its targeting position to its therapeutic position automatically or by user interention.
2 [0245j The feature that allows for automatic targeting of coils may be utilized in any device designed to stimulate nerve, body or other tissues with stimulatory or sub-stimulatory fields in which the device may be targeted based on a detectable signal or response.
102461 Other conditions that may be treated utilizing the various electromagnetic or magnetic induction stimulation systems and methods described herein include but are not :30 limited to, pelvic pain, interstitial cystitis, .t:Ãbromy al4gia, chronic fatigue and preterm labor, pain syndromes, Irritable Bowel vndroÃrie, ;'uh od)rnia, .Il. rpetiuc. new algta, tÃ'i;
neuralgia and Myofa:scial pain.

102481 The following Examples are provided for illyÃstration, not limitation.
One with skill in the art would be able to use these examples as guidelines for making and using comparable devices.
02491 In each example., interrnittent therapy should be applied and sya tptoms.'scores tracked :for a ..minimum of 6 weeks in order to determine the :full extent of the therapies effect.
[02501 Example 1: Empirical '1 esting of Efficacy in the Treaatment of Neuropathic.l'ai:n:
The optimal stimulus intensity for neuropathic pain treatment; the. optimal application parameters, i.e. frequency of stimulation, duration of t.Ãeatnient., location of stir-n- latory coils in each disposable array of coils; and the optimal coil diameter/placement within the strays can be determined using the following experimental protocol: Before, during and after treatment, patients will report scores of rieuropath.ic pain after weekly stimulation over a minimum. of 6 weeks, 102Ã+11 Example 2: Empirical Testing of Efficacy in the 'T'reatment of"
Neuromuscular Pain: The ell- cacy of neuromuscular pain treat rient. can be tested by rt .o -titoring patient reported pain scores. A standardized scale may be utilized and,, when feasible, local biopsy and blood tests can be useful in determining the impact of the therapeutic fields on circulating factors and local mediators. The optimal pulse atrmplitude, duration site of stimulation will be assessed based on reported pain scores and diagnostic tests.
102521 Example 3: Empirical 'I esting of ,"I icacy in the `I"reatment of Orthopedic conditions (Le., Art .rit.is, Back, pain and neck pain): The efficacy of arthritis treatment can be tested by monitoring patient reported. functionality scores. A
standardized. stÃbjective functionality scale may be utilized and, when feasible, local biopsy may be useful in determining the impact of the therapeutic fields on the cartilage and arthritic regions treated.
As cartilage destruction is a well-studied sire-eff=ect. of arthritis.
reduction of this degeneration will be a valuable marker for efficacy of therapeutic treatments.
The optimal pulse amplitude, duration, site of stimulation will be assessed based on reported functionality scores and diagnostic tests. Fain scores mayalso be measured to determine the device's impact on orthopedic conditions such as back pain, neck pain, etc. A
standardized pain scale may be used before and after treatment to determine potential.
benefit..
102531 It is also contemplated that any of the energy emitting; systems or devices described herein can be used with or without a sensor for detecting conduction of a stimulated raer;e or muscle of tissue stimÃÃlation resulting from the electromagnetic or magnetic field generated by the conductive coil and delivered to a patient or an electrical stimulras delivered to a patient. Also, in any of the above variations, a controller may optionally be connected, coupled, integral to or other-vise in communication with the conductive coils and/or the sensor. Optionally, the sensor may be connected, coupled, integral to or otherwise in communication with the conductive coil..
[0254j Each of the individual variations described and illustrated herein has discrete components and features which may be readily separated from or combined wi.tla. the features of any of the other variations. Modifications may he made to adapt a particular situation, .r ats rial, composition of matter process, process act(s) or step(s) to the objective(s), spirit or scope of the present inventio.Ãa..
[02551 Methods recited herein may be carried out in any order of the recited events which is logically possible, as well as the recited order of events.
Furthermore, where a range of values is provided, every intervening value between the upper and lower limit of fl-rat range and any other stated or intervening value in that stated range is encompassed within the invention. Also, any optional fea.ture of the inventive variations described may be set forth and claimed independently, or in con bination with any one or more of the features described herein.
102561 All existing subject matter mentioned herein (e.g., public~ationrs, patents, patent applications and hardware) is incorporated by reference herein in its entirety except insofar as the subject matter may conflict with that of the present invention (in w, vhich case what is present herein shall prevail). The referenced items are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an.
admission that the present invention is .not entitled to antedate such material by virtue of prior invention.
[02571 Reference to a singular item, includes the possibility that. there are plural of the same items present. N.-fore specifically:, as used herein and in the appended clairmms, the sirtgular farms "a," "an,-"said'" and "the" include plural re-f-events unless the context clear dictates otherwise_ It is further noted that the c ainias may be dratted to exclude any optional.
element, As such, this statement is intended to serve as antecedent basis for use of such exclusive, terraairacla gy as "solely" "only" and the like in connection with the recitation of claim elements. or use of a "negative" limitation. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill. in the art. to which this invention belongs.
102581 'I'bis disclosure is not intended to be limited to the scope of the particular forms set forth', but is i Ãtend_ed to cover alternatives, moditications, and equivalents of the variations described he.rein.:Further, the scope of the disclosure fully encompasses other variations that n aay become obvious to those skilled in the art in view of this disclosure. The scope Of the present iatN c ~ . a titan is Liracited only by the all end:c d c l a i m s .

Claims (28)

1. A system for electromagnetic induction therapy comprising:
at least one conductive coil disposed within or along an applicator, where the at least one coil is configured to generate a magnetic field focused on a target nerve in proximity to the at least one coil;
at least one sensor configured to detect electrical conduction in the target nerve or to detect a muscular response caused by an electrical conduction in the target nerve, the sensor configured to provide feedback about the efficacy of the applied electromagnetic induction therapy; and a controller in communication with the at least one sensor, where the controller is adjustable to vary a current through the at least one coil so as to adjust the magnetic field focused upon the target nerve.

2. The system of claim 1 wherein the applicator is configured to intermittently apply pulsed magnetic fields to a target nerve without causing habituation of the target nerve.

3. The system of claim 2 wherein the applicator is coded with markings to facilitate repetitive and consistent therapy onto a same body area.

4. The system of claim 1 wherein the applicator is configured to be positioned in proximity to a hand or arm and configured to generate a magnetic field focused on a target nerve within the hand or arm.

5. The system of claim 1 wherein the applicator is configured to be positioned in proximity to a back and configured to generate a magnetic field focused on a target nerve within the back.

6. The system of claim 5 wherein the applicator is configured to be aligned along a spine and configured to generate a magnetic field focused on nerve offshoots, dorsal root ganglion, spinal cord or vertebral body for osteoarthritis therapy, back or neck pain therapy, or to treat atrophy or paralysis.

7. The system of claim 1 wherein the applicator is held by a belt configured to be positioned on a back such that the cervica, thoracic, lumbar and/or sacral curvatures can hold the applicator in the optimal position.

8. The system of claim 1 wherein the applicator is configured to generate a magnetic field focused on a target nerve responsible for phantom or neuropathic pain to treat phantom or neuropathic pain.

9. The system of claim 1 wherein the applicator is configured to be positioned in proximity to patients face or head and configured to generate a magnetic field focused on a trigeminal nerve to treat facial neuralgia.

10. The system of claim 1 wherein the applicator is configured to be positioned over an occipital nerve and configured to generate a magnetic field focused on the occipital nerve to treat migraines.

11. The system of claim 1 wherein the applicator is configured to be positioned in proximity to a knee and configured to generate a magnetic field focused on the popliteal nerve to treat overactive bladder, neuropathic pain or restless legs.

12. A method of electromagnetic induction therapy, comprising:
positioning a first portion of a patient's body relative to an applicator such that a target nerve within the first portion of the body is in proximity to at least one conductive coil disposed within or along the applicator;
passing a current through the at least one coil to generate a magnetic field focused on the target nerve;

detecting electrical conduction through the target nerve or detecting a muscular response caused by an electrical conduction through the target nerve via at least one sensor positioned along a second portion of the body;
receiving a signal from the at least one sensor indicative of the electrical conduction thereby providing feedback about the efficacy of the applied electromagnetic induction therapy; and adjusting the current via a controller in communication with the at one conductive coil based on the feedback.

13. The method of claim 12 further comprising intermittently applying pulsed magnetic fields to a target nerve to treat a chronic condition without causing habituation of the target nerve.

14. The method of claim 12 wherein a patient's hand or arm is positioned relative to the applicator such that the magnetic field is focused on a target nerve within the hand or

15. The method of claim 12 wherein a patient's back is positioned relative to the applicator such that the magnetic field is focused on a target nerve within the back.

16. The method of claim 15 further comprising aligning the applicator along a spine such that the magnetic field is focused on nerve offshoots, dorsal root ganglion, spinal cord or vertebral body, for osteoarthritis therapy, back or neck pain therapy, or to treat atrophy or paralysis.

17. The method of claim 12 wherein the applicator is held by a belt and further comprising positioning the belt on a patient to allow the cervica, thoracic, lumbar and/or sacral curvatures to hold the applicator in the optimal position on the patient's back.

18. The method of claim 12 wherein the magnetic field is focused on a target nerve responsible for phantom or neuropathic pain to treat phantom or neoropathic pain.

19. The method of claim 12 wherein the magnetic field is focused on a target nerve to treat central or peripheral neuralgia.

20. The method of claim 12 wherein a patient's face or head is positioned relative to the applicator by placing the applicator in proximity to the patient's face or head such that the magnetic field is focused on a trigeminal nerve to treat facial neuralgia.

21. The method of claim 12 wherein a patient's occipital nerve is positioned relative to the applicator by placing the applicator in proximity to the patient's occipital nerve such that the magnetic field is focused on the occipital nerve to treat migraines.

22. The method of claim 12 wherein a patient's knee is positioned relative to the applicator such that the magnetic field is focused on the popliteal nerve to treat overactive bladder, neuropathic pain or restless legs.

23. The method of claim 12 wherein the magnetic field is focused on a target nerve to treat chronic pain, for up or down regulation of hormones, for cell proliferation, to treat atrophy, to treat neurogenic or overactive bladder or overactive bowel, to treat neuropathic pain, to treat orthopedic pain, or to treat arthritis.

24. A method of electromagnetic induction therapy, comprising:
positioning a first portion of a patient's body relative to an applicator such that a target nerve within the first portion of the body is in proximity to at least one conductive coil disposed within or along the applicator;
passing a current through the at least one coil to generate pulsed magnetic fields;
intermittently applying the pulsed magnetic fields to a target nerve to treat a chronic condition without causing habituation of the target nerve;
detecting electrical conduction through the target nerve or detecting a muscular response caused by an electrical conduction through the target nerve via at least one sensor positioned along a second portion of the body;

receiving a signal from the at least one sensor indicative of the electrical conduction thereby providing feedback about the efficacy of the applied electromagnetic induction therapy; and adjusting the current via a controller in communication with the at least one conductive coil based on the feedback.

25. A method of electromagnetic induction therapy, comprising:
positioning a first portion of a patient's body relative to an applicator such that a target tissue within the first portion of the body is in proximity to at least one conductive coil disposed within or along the applicator;
passing a current through the at least one coil to generate a magnetic field focused on the target tissue;
detecting stimulation of the target tissue via at least one sensor positioned along a second portion of the body or via detection by the patient;
receiving a signal from the at least one sensor or from the patient indicative of the tissue stimulation thereby providing feedback about the efficacy of the applied electromagnetic induction therapy; and adjusting the current via a controller in communication with the at least one conductive coil based on the feedback.

26. The method of claim 25 wherein a patient's frontal cortex is positioned relative to the applicator by placing the applicator in proximity to the patient's frontal cortex such that the magnetic field is focused on the frontal cortex to treat depression.

27. The method of claim 25 wherein the magnetic field is focused on a target tissue to treat osteoarthritis or arthritis.

28. The method of claim 25 wherein the magnetic field is focused on a target tissue to treat orthopedic conditions.