(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property Organization
`International Bureau
`
`(43) International Publication Date
`5 May 2011 (05.05.2011)
`
`PCT
`
`(51) International Patent Classification:
`A61N 1/00 (2006.01)
`
`(21) International Application Number:
`PCT/US20 10/054 167
`
`(22) International Filing Date:
`
`(25) Filing Language:
`
`(26) Publication Language:
`
`26 October 2010 (26.10.2010)
`
`English
`
`English
`
`(30) Priority Data:
`61/279,883
`
`26 October 2009 (26.10.2009)
`
`US
`
`(71) Applicant (for all designated States except US): EMKI-
`NETICS, INC. [US/US]; 49 Westdale Drive, Santa Cruz,
`California 95060 (US).
`
`(10) International Publication Number
`WO 2011/053607 Al
`
`AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ,
`CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO,
`DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT,
`HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP,
`KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD,
`ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI,
`NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD,
`SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR,
`TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
`
`(84) Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW, GH,
`GM, KE, LR, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG,
`ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ,
`TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK,
`EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, GG
`, LT, LU,
`LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK,
`SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ,
`GW, ML, MR, NE, SN, TD, TG).
`
`(72) Inventor; and
`(for US only): BURNETT, Daniel
`(75) Inventor/Applicant
`Rogers [US/US]; 588 Teresita Boulevard, San Francisco, Declarations under Rule 4.17 :
`California 94127 (US).
`— as to applicant's entitlement to apply for and be granted
`a patent (Rule 4.1 7(H))
`(74) Agents: GIOVANNETTI, Steven M. et al; Levine
`Bagade Han LLP, 2400 Geng Rd, Suite 120, Palo Alto, Published:
`California 94303 (US).
`— with international search report (Art. 21(3))
`
`(81) Designated States (unless otherwise indicated, for every
`kind of national protection available): AE, AG, AL, AM,
`
`(54) Title: METHOD AND APPARATUS FOR ELECTROMAGNETIC STIMULATION OF NERVE, MUSCLE, AND BODY
`TISSUES
`
`(57) 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 elec
`induction therapy. A controller
`tromagnetic
`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 with
`out causing habituation.
`
`o
`
`LUMENIS EX1082
`Page 1
`
`

`

`METHOD AND APPARATUS FOR ELECTROMAGNETIC STIMULATION OF
`
`NERVE, MUSCLE, AND BODY TISSUES
`
`CROSS-REFERENCE TO RELATED APPLICATIONS
`
`[0001]
`
`The present application claims benefit of priority to U.S. Provisional Patent
`
`Application Serial No. 61/279,883 filed October 26, 2009 which is incorporated by
`
`reference herein in its entirety for all purposes. The following applications are also
`
`incorporated herein by reference in their entirety for all purposes: U.S. Patent Application
`
`Serial No. 12/508,529 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. 12/695,087 filed January 27, 2010, which is a continuation of U.S.
`
`Patent Application Serial No. 11/332,797 filed January 17, 2006; U.S. Patent Application
`
`Serial Nos. 12/509,362 filed July 24, 2009; 12/469,365 filed May 20, 2009 which is a
`
`continuation of U.S. Patent Application Serial No.
`
`1/866,329 filed October 2, 2007 which
`
`claims priority to U.S. Provisional Patent Application Serial No. 60/848,720 filed October 2,
`
`2006, and 12/469,625 filed May 20, 2009 which is a continuation 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; and 12/509,304 filed July 24, 2009
`
`which is a continuation of U.S. Patent Application Serial No. 12/508,529 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; and 12/509,345 filed July 24, 2009 which is a
`
`continuation of U.S. Patent Application Serial No. 12/508,529 filed July 23, 2009 which is a
`
`continuation-in-part of U.S. Patent Application Serial No.
`
`1/866,329 filed October 2, 2007
`
`which claims priority to U.S. Provisional Patent Application Serial No. 60/848,720 filed
`
`October 2, 2006.
`
`BACKGROUND
`
`[0002]
`
`The concept of pulsed electromagnetic stimulation (PES) was first observed
`
`by the renowned scientist Michael Faraday in 1831 . Faraday was able to demonstrate that
`
`LUMENIS EX1082
`Page 2
`
`

`

`time varying, or pulsed electromagnetic fields have the potential to induce current in a
`
`conductive object. Faraday's experimental setup was simple. He found that by passing
`
`strong electric current through a coil of wire he was able to produce pulsed electromagnetic
`
`stimuli. This pulsed electromagnetic stimulus was able to induce the flow of current in a
`
`nearby electrically conductive body.
`
`[0003]
`
`In the years since the discoveries of Faraday, pulsed electromagnetic
`
`stimulators have found application in countless areas of scientific investigation.
`
`In 1965, the
`
`scientists Bickford and Freming demonstrated the use of electromagnetic stimulation to
`
`induce conduction within nerves of the face. Later, in
`
`82 Poison et al., U . S . Patent No.
`
`5,766,124 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
`
`activity, recording the first evoked potentials from electromagnetic stimulation.
`
`[0004]
`
`One of the earliest practical applications of electromagnetic stimulating
`
`technology took the form of a bone growth stimulator - a device that employed low
`
`frequency pulsed electromagnetic fields (PEMF) to stimulate bone repair. They first found
`
`use approximately 20 years ago in the treatment of non healing fractures, and are slowly
`
`becoming the standard of care for this condition.
`
`[0005]
`
`As investigators have studied the effects of electromagnetic fields on fracture
`
`healing, it has been demonstrated that PEMFs 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 signal transmission to decrease experienced pain, and
`
`(3) causing new cell growth in cartilage. These powerful effects of pulsed electromagnetic
`
`stimulation have been well established in laboratory studies of animal models and also in
`
`multiple large, double blind, placebo controlled studies of human subjects published in the
`
`medical literature.
`
`[0006]
`
`Erickson's U.S. Patent 5,181,902, 1/26/1993, which describes a device using
`
`a double transducer system with contoured, flat wound transducers intended to generate
`
`therapeutic flux-aided electromagnetic fields in 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 disadvantageous in at least two respects. First, the
`
`flat, wound nature of the coil in this device is limited in its delivery of pulsed
`
`LUMENIS EX1082
`Page 3
`
`

`

`electromagnetic fields to deep tissues of the body. Second, the rigid nature of this device,
`
`intended to provide bracing for patients recovering from spinal fusion 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, hand, or other joints and tissues.
`
`[0007]
`
`U . S . Patent 6,086,525, which discloses a device that has a single coil in the
`
`shape of a "C" where the intensity of the electromagnetic field is between the ends of the
`
`"C". That point must be employed directly over the target nerve or muscle to be stimulated.
`
`The coil is toroidal in configuration and utilizes a unique core of vanadium permendur 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 similar institutions. Also the vanadium permendur 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 during use.
`
`[0008]
`
`Tepper in U.S. Patent 5,314,401, 5/24/1994 describes a pulsed
`
`electromagnetic field transducer that is intended to be conformable to the contour of a
`
`patients body. The PEMF transducer in this application is described as having a desired
`
`form and sufficient rigidity to maintain an anatomical contour. This 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 manufactured to accommodate the
`
`contours of an endless variety of body shapes. Second, the intended device does not
`
`incorporate markings to ensure that the device is placed in a correct alignment over the
`
`targeted 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.
`
`[0009]
`
`In U.S. Patent 6,179,770 Bl, 1/30/2001, Mould describes dual coil
`
`assemblies in a magnetic stimulator for neuro-muscular 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 PEMF therapy. The design of this device is limited by the
`
`LUMENIS EX1082
`Page 4
`
`

`

`difficult nature of manipulating a single coil and the cost-intensive requirement of using
`
`highly skilled medical personnel for operation.
`
`[0010]
`
`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 EMF. 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 inherently
`
`inconsistent and non-uniform method for delivery, especially difficult with the intention of
`
`the device to provide a focused electromagnetic stimulus. Second, the device combines a
`
`static magnet with the electromagnet assembly in an attempt to create a unipolar, negative
`
`polarity field. This form of electromagnetic field stimulation has not been demonstrated to
`
`be effective in the treatment of osteoarthritis, musculoskeletal pain, or atrophy treatment.
`
`[0011]
`
`March's U.S. Patent 6,200,259 Bl, 3/13/2001 describes a device with
`
`electromagnetic field coils applied front and back to a patient for treating cardiovascular
`
`disease by angiogenesis. An EMF dosage plan contemplates, multiple coil implants and
`
`pulse variables including carrier frequency, pulse shape, duty cycle, and total time exposed.
`
`This device describes the placement of coils around the regions of tissues in which
`
`collateralization of blood flow (or angiogenesis) is desired. The design contemplates
`
`applications including the use of coils embedded in a cloth wrap, which 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 leg 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 not suggest any extension of the
`
`electromagnetic phenomenon in circumstances where PEMF stimulation can provide
`
`dramatic opportunities for the treatment of osteoarthritis, and musculoskeletal pains
`
`including tendonitis, 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 PEMF.
`
`[0012]
`
`Poison's U.S. Patent 5,766,124, 6/16/1998 describes a magnetic stimulator
`
`of neuro-muscular tissue. A reserve capacitor providing more efficiency in the control
`
`circuitry is devised. The description of the device, however, describes the stimulating coil in
`
`LUMENIS EX1082
`Page 5
`
`

`

`broad, generic terms, and does not contemplate 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.
`
`[0013]
`
`Schweighofer's U.S. Patent 6,123,658, 9/26/2000 describes a magnetic
`
`stimulation device which consists of a stimulation coil, a high-voltage capacitor, and a
`
`controllable network part. This device is intended to differentiate itself from low-voltage,
`
`low current devices by using a specific high-voltage, high current design to deliver PEMF
`
`for the purpose of triggering action potentials in deep neuromuscular tissue. This coil in this
`
`device is described as having a difficult and expensive to use hand-held configuration.
`
`[0014]
`
`Lin in U.S. Patent 5,857,957, issued Jan. 12, 1999 teaches the use of
`
`functional magnetic stimulation for the purpose of inducing a cough function in a
`
`mammalian subject. The description of the device provides for the use of hand-held
`
`stimulation 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 difficult 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 stimulation.
`
`[0015]
`
`Tepper in U.S. Patent No. 6,024,691 , issued 2/1 5/2000 describes a cervical
`
`collar with integral transducer for PEMF treatment. The description of this device provides
`
`for the use of a single coil transducer, formed into the shape of a cervical collar. This
`
`system is disadvantageous in several respects. First, this device does not provide for the use
`
`of solenoid-type coils in the delivery of PEMF, which can provide a uniform and consistent
`
`signal. Second, the semi-rigid design of the collar complicates the delivery of PEMF to
`
`persons of differing body sizes. That is, for a person with a larger than average (or smaller
`
`than average) size neck, the design and semi-rigid nature of the device would make an
`
`exacting fit difficult, thereby diminishing the effectiveness of any delivered therapy.
`
`Furthermore, 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
`
`difficult.
`
`LUMENIS EX1082
`Page 6
`
`

`

`[0016]
`
`Erickson in U.S. Patent No. 5,401,233, issued 3/28/1995 describes a neck
`
`collar device for the delivery of PEMF 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 of 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).
`
`[0017]
`
`olt in U.S. Patent No. 5,518,495, issued 5/21/1996 describes a coil wound
`
`on a large bobbin that permits the insertion of an arm 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, around 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 make it nearly impossible to approximate a metal 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
`
`stimulating 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 delivery of PEMF stimulation to the
`
`back would necessitate a large, cumbersome delivery system (into which the entire body
`
`would have to fit) in order to adequately deliver stimulation to targeted areas on the back or
`
`torso. Second, the device is described as a rigid bobbin through which the extremity is
`
`placed. This format makes application more difficult in that the applicator cannot be worn
`
`and therefore does not provide for 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
`
`magnetic flux density in the range of 4.5 to 6 gauss. Studies (such as Trock et al in the
`
`Journal of Rheumatology 1 94 ; 21(10): 1903-191 1) have shown that PEMF stimulation in
`
`LUMENIS EX1082
`Page 7
`
`

`

`the range of 15-25 or more gauss are effective in the treatment of osteoarthritis or other
`
`musculoskeletal pain conditions.
`
`[0018]
`
`Pollack in U.S. Patent No. 5,014,699, issued 5/14/1991 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 device
`
`does not provide for extension of this application to the treatment of other conditions, such
`
`as arthritis, musculoskeletal pain, or atrophy.
`
`[0019]
`
`Imran in US Pat App No 2006/0052839 filed 9/7/2005 describe the use of an
`
`implantable stimulator for the treatment of chronic back pain. While this modality may be
`
`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 stimulation.
`
`SUMMARY
`
`[0020]
`
`In certain variations, systems for electromagnetic induction therapy may
`
`include one or more conductive coils disposed within or along an applicator. The coils may
`
`be configured to generate a magnetic field focused on a target nerve, muscle or other body
`
`tissues in proximity to the coil. One or more sensors may be utilized to detect electrical
`
`conduction in the target nerve, to detect a muscular response caused by an electrical
`
`conduction in the target nerve, or to detect stimulation of a nerve, muscle or other body
`
`tissues and to provide feedback about the efficacy of the applied 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 focused 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.
`
`[0021]
`
`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.
`
`LUMENIS EX1082
`Page 8
`
`

`

`[0022]
`
`In certain variations, methods of electromagnetic induction therapy may
`
`include one or more of the following steps. A first portion of a patient's body may be
`
`positioned relative to or in proximity to an applicator or an applicator may be positioned
`
`relative to or in proximity to a first portion of a patient's body, such that a target nerve,
`
`muscle or tissue within the first portion of the body is in proximity to one or more
`
`conductive coils disposed within or along the applicator. A current may be passed through a
`
`coil to generate a magnetic field focused on the target nerve, muscle or tissue. An electrical
`
`conduction through the target nerve, a muscular response caused by an electrical conduction
`
`through the 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.
`
`[0023]
`
`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 magnetic fields may be intermittently applied or delivered a target nerve, muscle or
`
`tissue without causing habituation of the target nerve, muscle or tissue. Such intermittent
`
`magnetic fields may be used to treat chronic conditions, e.g., chronic pain, without causing
`
`habituation.
`
`[0024]
`
`In certain variations, applicators may be ergonomic or may be designed or
`
`configured to accommodate, 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,
`
`osteoarthritis, arthritis, back or neck pain, atrophy or paralysis, chronic pain, phantom or
`
`neuropathic pain, neuralgia, migraines, orthopedic conditions.
`
`[0025]
`
`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
`
`LUMENIS EX1082
`Page 9
`
`

`

`[0026]
`
`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.
`
`[0027]
`
`FIG. 1 is a schematic view of an apparatus for magnetic induction therapy
`
`according to a first variation.
`
`[0028]
`
`FIG. 2 is a schematic view of an apparatus for magnetic induction therapy
`
`according to a second variation.
`
`[0029]
`
`FIG. 3 is a schematic view of an apparatus for magnetic induction therapy
`
`according to a third variation.
`
`[0030]
`
`FIG. 4 is a schematic view of an apparatus for magnetic induction therapy
`
`according to a fourth variation.
`
`[0031]
`
`FIG. 5 is a schematic view of an apparatus for magnetic induction therapy
`
`according to a fifth variation.
`
`[0032]
`
`FIGS. 6A-6D are schematic illustrations depicting a first method of use of an
`
`apparatus for magnetic induction therapy. This method is based on adjusting the position of
`
`the conductive coils so to optimize a magnetic flow applied to a target nerve.
`
`[0033]
`
`FIGS. 7A-7D are schematic illustrations of a second method of use of an
`
`apparatus for magnetic induction therapy. This method is based on locking the conductive
`
`coils in position once electrical conduction in a target nerve has been detected.
`
`[0034]
`
`[0035]
`
`FIG. 8 is a schematic view of a variation that includes a plurality of sensors.
`
`FIGS. 9A-9D are schematic representations of different garments adapted to
`
`operate as apparatus for magnetic induction therapy.
`
`[0036]
`
`FIG. 10 is a schematic view of an apparatus for providing electrical
`
`stimulation.
`
`[0037]
`
`FIG. 11 is a schematic view of another variation of an apparatus for
`
`providing electrical stimulation.
`
`[0038]
`
`FIG. 12 shows a schematic view of an energy emitting system including a
`
`microneedle patch sensor.
`
`[0039]
`
`patches.
`
`FIG. 13-15 shows magnified bottom views of variations of microneedle
`
`LUMENIS EX1082
`Page 10
`
`

`

`[0040]
`
`patch.
`
`[0041]
`
`[0042]
`
`FIGS. 16-17 shows magnified side views of variations of a microneedle
`
`FIG. 18 shows a magnified bottom perspective view of a microneedle patch.
`
`FIG. 9 shows a representative cross sectional view of the skin composed of
`
`an outer stratum corneum covering the epidermal and dermal layers of skin and the
`
`underlying subcutaneous tissue, with a variation of a microneedle patch attached thereto.
`
`[0043]
`
`FIG. 20a shows a magnified side view of a variation of a microneedle patch
`
`including multiple electrodes.
`
`[0044]
`
`FIG. 20b-20D show variations of a microneedle patches including multiple
`
`electrodes.
`
`[0045]
`
`FIG. 2 1 shows a schematic view of an energy emitting system including a
`
`microneedle patch sensor placed behind a subject's knee.
`
`[0046]
`
`FIGS. 22-23 show schematic views of energy emitting systems including an
`
`electrode needle and sensor.
`
`[0047]
`
`FIGS. 24-25 show schematic views of energy emitting systems including an
`
`electrode needle without a sensor.
`
`[0048]
`
`FIG. 26 shows a schematic view of an energy emitting system including a
`
`microneedle patch for providing stimulation.
`
`[0049]
`
`FIGS. 27-28 show schematic views of energy emitting systems including an
`
`electrode needle and microneedle patch for providing stimulation.
`
`[0050]
`
`FIG. 29a-29d show a prospective, side, top and rear views of an energy
`
`emitting device in the form of a foot cradle.
`
`[0051]
`
`FIGS 30A-30B show schematic views of an energy emitting device in the
`
`form of a knee support.
`
`[0052]
`
`FIGs. 3 1A-3 1B show a schematic view of a variation of an arm applicator
`
`and a foot, knee or leg applicator.
`
`[0053]
`
`[0054]
`
`FIG. 32 shows a schematic view of a variation of a back applicator.
`
`FIG. 33 shows a schematic view of a variation of a system including a back
`
`applicator, a sensor and logic controller.
`
`[0055]
`
`FIG. 34 shows a schematic view of system including multiple back
`
`applicators, a sensor and logic controller.
`
`LUMENIS EX1082
`Page 11
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`

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`[0056]
`
`FIG. 35 shows a schematic view of a variation of a system including a back
`
`applicator held on a patient's body by an ergonomic positioning element in the form of a
`
`belt and a logic controller.
`
`[0057]
`
`FIG. 36 shows a schematic view of a variation of an applicator designed to
`
`stimulate a nerve responsible for phantom or neuropathic pain.
`
`[0058]
`
`FIG. 37 shows a schematic view of a variation of a facial neuralgia
`
`applicator.
`
`[0059]
`
`FIG. 38 shows a schematic view of a variation of an applicator which may be
`
`placed over the occipital nerve for the treatment of migraines.
`
`[0060]
`
`FIG. 39 shows a schematic view of a variation of an applicator which may be
`
`placed over the frontal cortex for the treatment of depression.
`
`[0061]
`
`FIG. 40 shows a schematic view of a variation an applicator in the form of a
`
`stimulatory coil platform for positioning one or more coils in proximity to a knee or
`
`popliteal nerve.
`
`[0062]
`
`FIG. 4 1 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.
`
`[0063]
`
`Figures 42A and 42B show an example of how the amount of stimulatory
`
`power required to achieve a desired stimulus may be automatically adjusted as a result of
`
`fibroses.
`
`[0064]
`
`Figures 43A and 43B show variations of a coil device positioned on a skull.
`
`DETAILED DESCRIPTION
`
`[0065]
`
`In certain variations, apparatus and methods for magnetic induction therapy,
`
`in which dosage of magnetic energy can be regulated according to conduction in a target
`
`nerve exposed to the magnetic field are provided.
`
`[0066]
`
`In certain variations, apparatus and methods for magnetic induction therapy,
`
`in which the flow of magnetic energy can be adjusted directionally by the patient or a
`
`healthcare provider without altering the position of a housing containing conductive coils
`
`that produce the magnetic field are provided.
`
`LUMENIS EX1082
`Page 12
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`[0067]
`
`In certain variations, apparatus and methods for treating a variety of ailments
`
`by providing energy to a target nerve, for example magnetic energy, electrical energy or
`
`ultrasound energy, at a location and in an amount optimized by detecting conduction in the
`
`target nerve are provided.
`
`[0068]
`
`In certain variations, an energy emitting apparatus for delivering a medical
`
`therapy that includes one or more energy generators, a logic controller electrically connected
`
`to the one or more energy generators, and one or more sensors for detecting electric
`
`conduction in a target nerve, which are connected to the logic controller is provided. The
`
`one or more energy generators produce energy focused on the target nerve upon receiving a
`
`signal from the logic controller, and the applied energy is varied by the logic controller
`
`according to an input provided by the one or more sensors based on electric conduction in
`
`the target nerve. The feedback provided by the sensors to the logic controller about the
`
`efficacy of the applied treatment causes the logic controller to modulate the current
`
`transmitted to the coils.
`
`[0069]
`
`The applied energy may be a magnetic field, an electrical field, an ultrasound,
`
`a visible light, or an infrared or an ultraviolet energy. When a magnetic field is applied, the
`
`energy-emitting device is an apparatus that provides a magnetic induction therapy and that
`
`includes one or more conductive coils disposed in an ergonomic housing. A logic controller
`
`is electrically connected to the one or more coils, and one or more sensors detect electric
`
`conduction in the target nerve and are connected to the logic controller so to provide a
`
`feedback to the logic controller. The conductive coils receive an electric current from the
`
`logic controller and 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, frequency or direction of the magnetic
`
`field, or the firing sequence of the one or more coils, to be varied according to the efficiency
`
`of the treatment provided to the target nerve. In certain variations, the housing containing
`
`the conductive coils may be a flexible wrap, a cradle or a garment, and the coils may be
`
`overlapping and/or be disposed in different positions within the housing, so to generate a
`
`magnetic field on different body parts with the desired direction and amplitude.
`
`[0070]
`
`The one or more coils may be stationary or movable within the housing,
`
`making it possible to optimize the direction of magnetic flow to the target nerve by
`
`LUMENIS EX1082
`Page 13
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`

`disposing the coils in the most effective direction. In different variations, the coils may be
`
`movable manually by acting on a knob, lever, or similar type of actuator, or may be
`
`translated automatically by the logic controller in response to the input provided by the
`
`sensors. When a p