Attorney Docket No.: EMKNZONDOUS
`
`METHOD AND APPARATUS FOR TRANSDERMAL ST€MULATION OVER
`
`THE PALMAR AND PLANTAR SURFACES
`
`CROSS-REFERENCE TO RELATED APPLICATIONS
`
`5
`
`[0001]
`
`This application is a continuation in part of PCT International Patent
`
`Application Number PCT/US2011/052415, filed September 20, 2011, which claims
`
`benefit of priority to U.S. Provisional Patent Application Serial No. 61/403,680 filed.
`
`September 20, 2010. The present application is also a continuation-in part of U.S. Patent
`
`Application Serial No. 12/508,529 filed July 23, 2009, which is a continuation-in--part of
`
`10 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. Each of the above referenced applications is incorporated herein by reference in
`
`their entirety.
`
`[00021
`
`The following applications are also incorporated herein by reference in
`
`15
`
`their entirety for all purposes: PCT Application Serial No. PCT/US10/541€i7 filed
`
`October 26, 2010; PCT Application Serial No. PCT/USI 0/054353 filed October 27,
`
`2010; 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
`
`20
`
`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. 11/866,329 filed October 2, 2007 which claims priority to U.S. Provisional Patent
`
`25 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
`
`30
`
`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. 11/866,329 filed October
`
`Petitioner - Avation Medical, Inc.
`Ex. 1044, p. 1
`
`

`

`Attorney Docket No.: EMKNZONDOUS
`
`2, 2007 which claims priority to U.S. Provisional Patent Application Serial No.
`
`60/848,720 filed October 2, 2006.
`
`FIELD OF THE INVENTION
`
`10003]
`
`The present apparatus and methods relate generally to energy emitting
`
`apparatus and methods for providing a medical therapy. The apparatus and methods may
`
`provide for central and peripheral nerve and other tissue modulation or stimulation
`
`therapies
`
`10
`
`BACKGROUND
`
`The O.AB and t JI market in the United States is well over a $12 billion a
`10004]
`year industry, It affects over 16% of all Americans, for a total U.S. market o₹
`approximately 34 million men and women each year. Due to social stigmas attached to
`
`15 OAB and UT, as well as misunderstanding of the signs and symptoms associated with
`
`OAB and
`
`only 40% of those affected (13.6M) seek treatment. Of those 13.6 million
`
`individuals, nearly 30% are unsatisfied with their current therapy.
`
`10005]
`established as a beneficial therapy in a variety of medical applications. The scientific
`
`The use of pulsed electromagnetic stimulation (PBS) has been well
`
`20
`
`principle behind this technology is that an electric current passed through a coil will
`
`generate an electromagnetic field. These fields, in turn, have been shown. to induce
`
`current within conductive materials placed within the field. When applied to the human
`
`body, pulsed electromagnetic stimulation has been found to be an effective method of
`
`stimulating nerves resting within the electromagnetic field, Recent data highlights the
`
`25
`
`beneficial effects of invasive, needle-based. electrostimulation (ES) of the posterior tibial
`
`nerve in individuals with OAB and Ul. ES has been found to modulate bladder
`
`dysfunction through its action on the pudendal nerve and the sacral plexus which
`
`provides the major excitatory input to the bladder.
`
`10006
`
`Current treatment options for OAB and UI are exercise and behavioral
`
`30 modifications, pharmacological therapies, surgical intervention, and neuromodulation.
`
`Although each of these treatment options targets the Ul and OAB populations, each has
`
`severe limitations.
`
`[0007]
`
`Exercise and behavioral modifications often require patients to adhere to
`
`stringent routines, including scheduled voiding, maintenance of a bladder diary, and.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1044, p. 2
`
`

`

`Attorney Docket No.: EMKNZONDOUS
`
`intense exercise regiments. While this may be a viable option for a small group of highly
`
`dedicated individuals, its daily impact on one's life makes it an unattractive option for
`
`most individuals.
`
`10008]
`
`Pharmacological intervention is the most widely prescribed therapy for
`
`OAB and UT. Unfortunately, as with the ingestion of any chemical, patients are often
`
`subject to side effects from their drug therapy. This is especially detrimental in older and
`
`elderly patient populations where interaction with other prescribed medications can have
`
`adverse effects. Further, there is a high rate of dissatisfaction, approximately 30%,
`
`amongst individuals using pharmacological treatment.
`
`1.0
`
`10009]
`
`Surgical intervention is an extremely invasive treatment and often results
`
`in the long-term, and in some cases permanent, requirement for catheterization. The high
`
`expense of these procedures, coupled with the negative impact the procedures have on
`
`the patients quality of life, make this an. option only when all other treatment options
`
`have been exhausted.
`
`15
`
`1001.0i
`
`Neuromodulation is another treatment alternative for OAB and UT
`
`patients. Sacral nerve stimulation (SNS) has shown itself to be an effective treatment
`
`option for those with OAB or HI. However, the procedure requires the permanent
`
`implantation of an electrical stimulation device in the patient. One estimate puts the cost
`
`at nearly $14,000 with additional routine care costs of $593 per patient per year.
`
`20 Additionally, SNS's risk of battery failure, implant infection, and electrode migration,
`
`lead to a high reoperation rate and make this procedure unattractive.
`
`10011]
`
`More recently, the introduction of a posterior tibial nerve stimulator, often
`
`referred to as SANS, has shown itself to be another neuromodulation alternative. Yet as
`
`is the case with other forms of neuromodulation, this system is invasive in. its nature. _It
`
`25
`
`requires the insertion of a needle two inches into the patient's ankle region in order to
`
`stimulate the posterior tibial nerve. As well, it requires a minim um of 12 sessions for
`
`initial treatment, with the possibility of additional sessions needed for maintenance.
`
`Despite its high cost and invasive nature, though, an abundance of published peer-
`
`reviewed clinical trials demonstrate the safety and efficacy of the SANS therapy.
`
`30
`
`3
`
`Petitioner - Avation Medical, Inc.
`Ex. 1044, p. 3
`
`

`

`Attorney Docket No.: EMKNZONDOUS
`
`SUMMARY
`
`100121
`
`In certain variations, a method for providing transdennal electrical
`
`stimulation therapy to a patient is provided. The method may include positioning a
`
`stimulator electrode over a glabrous skin surface overlying a target nerve of a subject.
`
`S
`
`Electrical stimulation may be delivered through or across the glabrous skin surface to the
`
`target nerve to stimulate the target nerve, while remaining safe and tolerable to the
`
`patient. Electrical stimulation may be delivered at frequencies that may be painful or
`
`intolerable when applied over non-glabrous surfaces of the body. The electrical
`
`stimulation may be utilized to treat various conditions, e.g., urinary incontinence and
`
`10
`
`overactive bladder.
`
`10013j
`
`In certain variations, an applicator, e.g., an ergonomic applicator, for
`
`providing transdermal electrical stimulation therapy to a patient is provided. The
`
`applicator may be configured to position a stimulator electrode over a glabrous skin
`
`surface of the subject to deliver transdermal electrical stimulation through or across the
`
`15
`
`glabrous skin surface to an underlying target nerve, resulting in stimulation of the target
`
`nerve.
`
`10014]
`
`In certain variations, a method for providing an energy based stimulation
`
`therapy to a subject is provided. The method may include positioning an energy emitting
`
`device in proximity to a glabrous surface overlying a target tissue. Energy may be
`
`20
`
`delivered through the glabrous skin surface to the target tissue to stimulate the target
`
`tissue.
`
`10015]
`
`In certain variations, another method. for providing an energy based
`
`stimulation therapy to a subject is proved. The method may include positioning an
`
`energy emitting device in proximity to a skin surface overlying a target nerve. Energy
`
`25 may be delivered at a frequency of about 1 Hz to about 30 Hz through the skin surface to
`
`the target nerve, thereby generating motor andlor sensory nerve conduction of the target
`
`nerve while remaining safe and tolerable to the subject. Optionally, energy may be
`
`delivered at less than 10 Hz to generate nerve conduction.
`
`1001.6]
`
`In certain variations, systems for electromagnetic induction therapy may
`
`30
`
`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
`
`4
`
`Petitioner - Avation Medical, Inc.
`Ex. 1044, p. 4
`
`

`

`Attorney Docket No.: EMKNZONDOUS
`
`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
`
`S
`
`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.
`
`100171
`
`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.
`
`10
`
`100181
`
`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
`
`15
`
`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
`
`20
`
`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.
`
`10019]
`
`Optionally, a user may detect stimulation of a nerve, muscle or body
`
`25
`
`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.
`
`30
`
`100201
`
`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
`
`5
`
`Petitioner - Avation Medical, Inc.
`Ex. 1044, p. 5
`
`

`

`Attorney Docket No.: EMKNZ00700US
`
`example, osteoarthritis, arthritis, back or neck pain, atrophy or paralysis, chronic pain,
`
`phantom or neuropathic pain, neuralgia, migraines, orthopedic conditions.
`
`100211
`
`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
`
`100221
`
`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
`
`10
`
`understood that in. some instances various aspects of the embodiments may be shown
`
`exaggerated or enlarged to facilitate an understanding of the embodiments.
`
`100231
`
`FIG, I is a schematic view of an apparatus for magnetic induction therapy
`
`according to a first variation.
`
`100241
`
`FIG. 2 is a schematic view of an apparatus for magnetic induction therapy
`
`15
`
`according to a second variation.
`
`100251
`
`FIG. 3 is a schematic view of an apparatus for magnetic induction therapy
`
`according to a third variation.
`
`100261
`
`FIG. 4 is a schematic view of an apparatus for magnetic induction therapy
`
`according to a fourth variation.
`
`20
`
`100271
`
`FIG. 5 is a schematic view of an apparatus for magnetic induction therapy
`
`according to a fifth variation.
`
`100281
`
`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.
`
`25
`
`100291
`
`FIGS. 7A-7D arc 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.
`
`100301
`
`30
`
`sensors.
`
`FIG. 8 is a schematic view of a variation that includes a plurality of
`
`100311
`
`FIGS. 9A-9D are schematic representations of different garments adapted
`
`apparatus for magnetic induction therapy.
`to operate as
`
`100321
`
`FIG. 10 is a schematic view of an apparatus for providing electrical
`
`stimulation.
`
`6
`
`Petitioner - Avation Medical, Inc.
`Ex. 1044, p. 6
`
`

`

`Attorney Docket No.: EMKNZONDOUS
`
`100331
`
`FIG. 11 is a schematic view of another variation of an apparatus for
`
`providing electrical stimulation.
`
`[00341
`
`FIG. 12 shows a schematic view of an energy emitting system including a
`
`microneedle patch sensor.
`
`[0035]
`
`patches.
`
`[00361
`
`patch.
`
`[00371
`
`10
`
`patch.
`
`FIG. 13-15 shows magnified bottom views of variations of microneedle
`
`FIGS. 16-17 shows maanified side views of variations of a microneedle
`
`FIG. 18 shows a magnified bottom perspective view of a microneedle
`
`[00381
`
`FIG. 19 shows a representative cross sectional view of the skin composed
`
`of an outer stratum corneu.m covering the epidermal and dermal layers of skin and the
`
`underlying subcutaneous tissue, with a variation of a microneedle patch attached thereto.
`
`[00391
`
`FIG. 20a shows a magnified side view of a variation of a microneedle
`
`15
`
`patch including multiple electrodes.
`
`[00401
`
`FIG. 20b-20D show variations of a microneedle patches including
`
`multiple electrodes.
`
`[0041]
`
`FIG. 21 shows a schematic view of an energy emitting system including a
`
`microneedle patch sensor placed behind a subject's knee.
`
`20
`
`[0042]
`
`FIGS. 22-23 show schematic views of energy emitting systems including
`
`an electrode needle and sensor.
`
`[00431
`
`FIGS. 24-25 show schematic views of energy emitting systems including
`
`an electrode needle without a sensor.
`
`[00441
`
`FIG. 26 shows a schematic view of an energy emitting system including a
`
`25 microneedle patch for providing stimulation.
`
`[0045]
`
`FIGS. 27-28 show schematic views of energy emitting systems including
`
`an electrode needle and microneedle patch for providing stimulation.
`
`[00461
`
`FIG. 29a-29d show a prospective, side, top and rear views of an energy
`
`emitting device in the form of a foot cradle.
`
`30
`
`[00471
`
`FIGS 30a-30b show schematic views of an energy emitting device in the
`
`form of a knee support.
`
`100481
`
`FIGS. 31a-31b shows a schematic view of a variation of an arm applicator
`
`and a foot, knee or leg applicator.
`
`[0049]
`
`FIG. 32 shows a schematic view of a variation of a back applicator.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1044, p. 7
`
`

`

`Attorney Docket No.: EMKNZONDOUS
`
`100501
`
`HG. 33 shows a schematic view of a variation of a system including a
`
`back applicator, a sensor and logic controller.
`
`10051]
`
`FIG. 34 shows a schematic view of system including multiple back
`
`applicators, a sensor and logic controller.
`
`[0052]
`
`FIG. 35 shows a schematic view of a variation of a system including a
`
`back applicator held on a patient's body by an ergonomic positioning element in the
`
`form of a belt and a logic controller.
`
`100531
`
`FIG. 36 shows a schematic view of a variation of an applicator designed
`
`to stimulate a nerve responsible for phantom or neuropathic pain.
`
`10
`
`10054]
`
`FIG. 37 shows a schematic view of a variation of a facial neuralgia
`
`applicator.
`
`10055]
`
`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.
`
`100561
`
`FIG. 39 shows a schematic view of a variation of an applicator which may
`
`15
`
`be placed over the frontal cortex for the treatment of depression.
`
`100571
`
`FIG. 40 shows a schematic view of a variation an applicator in the form of
`
`a stimulator coil platform for positioning one or more coils in proximity to a knee or
`
`popliteal nerve.
`
`[0058]
`
`FIG. 41 shows a schematic view of a system including a variation of a
`
`20
`
`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.
`
`100591
`
`Figures 42A and 42B show an example of how the amount of stimulator
`
`power required to achieve a desired stimulus may be automatically adjusted as a result of
`
`fibroses.
`
`25
`
`10060]
`
`Figures 43A and 43B show variations of a coil device positioned on a
`
`skull.
`
`10061]
`
`Figure 44 shows a view of the underside or glabrous surface of the foot
`
`and exemplary sites for delivering electrical stimulation.
`
`100621
`
`Figure 45 shows a perspective view of one variation of an insole for
`
`30
`
`delivering electrical stimulation over a glabrous surface of the foot.
`
`10063]
`
`Figure 46 shows a perspective view of a variation of an insole for
`
`delivering electrical stimulation over a glabrous surface of the foot, including a sensor
`
`feedback feature.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1044, p. 8
`
`

`

`Attorney Docket No.: EMKNZONDOUS
`
`100641
`
`Figure 47 shows a perspective view of one variation of electrodes for
`
`delivering electrical stimulation over a glabrous surface of a foot.
`
`100651
`
`Figure 48 shows a perspective view of one variation of a hand applicator
`
`for delivering electrical stimulation over a glabrous surface of a hand.
`
`100661
`
`Figure 49 shows a perspective view of one variation of electrodes for
`
`delivering electrical stimulation over a glabrous surface of a hand.
`
`100671
`
`Figure 50 shows an example of an EMG reading.
`
`DETAILED DESCRIPTION
`
`10
`
`100681
`
`In certain variations, various apparatus and methods for providing
`
`magnetic induction therapy or electrical stimulation therapy are provided. In certain
`
`variations, various apparatus and methods may provide for central and peripheral nerve
`
`and other tissue modulation or stimulation therapies, including both excitation and.
`
`blocking of nerve impulses. In certain variations, a low frequency induction therapy may
`
`15
`
`be performed. In certain variations, these apparatus and methods may be useful in the
`
`treatment and prevention of urinary incontinence (UI), overactive bladder (0AB) and
`
`other conditions.
`
`100691
`
`In certain variations, apparatus and methods for magnetic induction
`
`therapy, in which dosage of magnetic energy can be regulated according to conduction in
`
`20
`
`a target nerve exposed to the magnetic field are provided.
`
`100701
`
`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.
`
`25
`
`100711
`
`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.
`
`100721
`
`In certain variations, an energy emitting apparatus for delivering a
`
`30 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
`
`9
`
`Petitioner - Avation Medical, Inc.
`Ex. 1044, p. 9
`
`

`

`Attorney Docket No.: EMKNZONDOUS
`
`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.
`
`10073]
`
`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
`
`10 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,
`
`15
`
`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
`
`20
`
`parts with the desired direction and amplitude.
`
`100741
`
`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
`
`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
`
`25
`
`translated automatically by the logic controller in response to the input provided by the
`
`sensors. When a preferred position for the coils has been established, the coils may be
`
`locked in position and maintain that position during successive therapy sessions. In other
`
`variations, the sensors may be incorporated within the housing, or instead may be
`
`disposed on a body part of interest independently of the housing.
`
`30
`
`10075]
`
`In still other variations, the inductive coils are disposed in a housing that
`
`is situated externally to a 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 an implantable device. In yet other variations, the
`
`10
`
`Petitioner - Avation Medical, Inc.
`Ex. 1044, p. 10
`
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`Attorney Docket No.: EMKNZONDOUS
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`electric current may varied by the logic controller both on the basis of an input provided
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`by the one or more sensors and also an input provided by the patient according to a
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`muscular response she has perceived, for example, the twitching of a toe after application
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`of the magnetic field.
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`100761
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`In yet other variations, the source of energy for nerve stimulation may be
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`electrical energy and nerve conduction may be detected at a site sufficiently distant from
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`the site of stimulation, so to enable detection of nerve conduction despite any
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`interference from the direct electrical stimuli. In these variations, direct electrical
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`stimulation of nerve and muscle may be tailored to provide optimal therapy and, in the
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`10
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`case of electrode migration or other electrode malfunction, to report lack of stimulation
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`of the bodily tissues, Furthermore, these variations enable a reduction in power
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`requirement, because control of the signal is provided by the sensor to the signal
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`generator loop.
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`100771
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`in other variations, an energy emitting system for providing a medical
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`15
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`therapy is provided. The system may include one or more conductive coils disposed
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`within or along a housing and configured to generate a magnetic field focused on a target
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`nerve in proximity to coils; one or more sensors in the form of microneedie patch.
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`configured. to detect electrical conduction in the target nerve; and a controller coupled to
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`the conductive coils and optionally in communication with the sensoL
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`20
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`100781
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`In other variations, an energy emitting system for providing a medical
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`therapy is provided. The system may include one or more microneedle patches having
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`one or more microneedle arrays deposited on a surface of one or more electrodes and
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`configured to generate or deliver an electrical or magnetic stimulus or field focused on a
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`target nerve in proximity to the microneedle patch; one or more sensors configured to
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`25
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`detect electrical conduction in the target nerve; and a controller coupled to the
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`conductive coils and optionally in communication with the sensor. Optionally, the above
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`variations may incorporate an electrode needle. Optionally, the above variations or
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`systems may be utilized without a sensor or mechanism for detecting conduction or
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`stimulation.
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`30
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`100791
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`Methods of use of the above apparatus, systems and variations thereof for
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`treating various conditions are also described herein,
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`100801
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`Referring first to FIG. 1. a first variation includes a coil wrap 20, which is
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`depicted as disposed over ankle 22 circumferentially to surround a portion of tibial nerve
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`24. Because tibial nerve 24 is targeted, this variation is particularly suited for the
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`11
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`Petitioner - Avation Medical, Inc.
`Ex. 1044, p. 11
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`Attorney Docket No.: EMKNZ00700US
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`treatment of OAB and VI. In other variations, coil wrap 20 may be configured to
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`surround other body parts that contain a portion of tibial nerve 24 or of other nerves
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`branching from. or connected to tibial nerve 24, still making these variations suitable for
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`treating OAB and VI, In still other variations, coil wrap 20 may be configured for
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`surrounding body parts that contain other nerves when treatments of other ailments are
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`intended.
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`100811
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`Coil wrap 2.0 may be manufactured from a variety of materials suitable
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`for wearing over ankle 22. Preferably, coil wrap is produced from a soft, body-
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`compatible material, natural or synthetic, for example, cotton, wool, polyester, rayon,
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`1.0 Gore-Tex®, or other fibers or materials known to a person skilled in the art as non-
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`irritating and. preferably breathable when tailored into a garment. Coil wrap 22 may even
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`be manufactured from a molded or cast synthetic material, such as a urethane gel, to add
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`extra comfort to the patient by providing a soft and drapable fed, Additionally, coil wrap
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`2.0 may be produced from a single layer of material or from multiple material layers and
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`15 may include padding or other filling between the layers.
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`100821
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`Coil wrap 20 contains one or more conductive coils 26 arranged to
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`produce a pulsed magnetic field that will flow across tibial nerve 24 and generate a
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`current that will flow along tibial nerve 24 and spread. along the length of tibial nerve 24
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`all the way to its sacral or pudendal 'Imre root origins. Coils 26 may be a single coil
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`20
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`shaped in a simple helical pattern or as a figure eight coil, a four leaf clover coil, a
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`Helmholtz coil, a modified Helmholtz coil, or may be shaped as a combination of the
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`aforementioned coils patterns. Additionally, other coil designs beyond those mentioned
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`hereinabove might be utilized as long as a magnetic field is developed that will
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`encompass tibial nerve 24 or any other target nerve. When a plurality of coils is utilized.,
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`25
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`such coils may be disposed on a single side of ankle 22, or may be disposed on more
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`than one side, for example, on opposing sides, strengthening and directionalizing the
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`flow of the magnetic field through tibial nerve 24 or other peripheral nerves of interest.
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`100831
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`Coil wrap 20 is preferably configured as an ergonomic wrap, for example,
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`as an essentially cylindrical band that can be pulled over ankle 22, or as an open band
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`30
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`that can be wrapped around ankle 22 and have its ends connected with a buckle, a hoop
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`and loop system, or any other closing system known to a person skilled in the art. By
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`properly adjusting the position of coil wrap 20 over ankle 22, a patient or a health care
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`provider may optimize the flow of the magnetic field through tibial nerve 24, based on
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`Petitioner - Avation Medical, Inc.
`Ex. 1044, p. 12
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`Attorney Docket No.: EMKNZONDOUS
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`system feedback or on sensory perceptions of the patient, as described in greater detail
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`below,
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`[00841
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`The electric current that produces the magnetic field by flowing through
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`coils 26 is supplied by a programmable logic controller 28, which is connected to coils
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`5
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`26, fir example, with a power cord 32. A sensor 30 that feeds information to logic
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`controller 28 is also provided., in order to tailor the strength of the magnetic field and
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`control activation of coils 26 based on nerve conduction. The purpose of sensor 30 is to
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`detect and record the firing of the target nerve and to provide related information to logic
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`controller 28, so to render the intended therapy most effective. For example, sensor input
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`10 may cause logic controller 28 to alter the strength or pulse amplitude of the magnetic
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`field based on sensor input, or fire the coils in a certain sequence.
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`[00851
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`In this variation, as well as in the other variations described hereinaft