Attorney Docket 0.: ElvIKNNZ.00703
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`MET .0D AND APPARATUS" YR IRANSDER.MAL STIMULATION -WEll
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`PALMAR AND PLANTAR. SURFACES
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`CROSS-REFERENCE TO 1 ELATED}`LPP:LICA TI NS
`
`100011 This apPlication is. a c.pittintiatiort-in-part of U S. patent application NO. 15/084,3:56 Med
`March 29, 2€316 which is a continuation of U.S. patent application 13/840,936 filed March 15.
`
`201.3 (now U.S. patent 9,339,641 issued May 17, 2016), which is a continuation in part of :PCT
`
`International Patent Application Number PCTIUS2011.1052415, filed September 20, 2011, which.
`
`claims benefit of priority to U.S. Provisional Patent Application No. 61/403,680 filed September
`
`20, 2010, The present application is also a continuation-in part of U.S. patent application No.
`
`12/508,529 filed July 23, 2009, which is a continuation-in-part of U.S. pa€ent applica€ion
`
`'No.
`
`1 .1/866,329 filed. October 2, 2007, which claims priority to U.S. Provisional Patent Application
`
`No. 60/848,720 filed October 2, 2.006. The present application also claims priority to U.S.
`
`Provisional .Patent Application No. 62/350,610 filed. June 1.5, 2016. .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 their entirety for
`
`all purposes: PCT Application Serial No. PCT/US1.0/54167 filed. Oct. 26, 2010; PCT Application
`
`Serial No. PCT/US10/054353 filed Oct. 27, 2010; U.S. patent application Ser. No. 12/50.8,529
`
`filed Jul. 23, 2009, which is a continuation in part of U.S. patent application Set No. 11/866,329
`
`filed Oct. 2, 2007, which claims priority to U.S. Provisional Patent Application Set No.
`
`601848,720 filed Oct. 2, 2006; U.S. patent application Ser. No. 12/695,087 filed Jan.. 27, 2010,
`
`which is a continuation of U.S. patent application Ser. No. 11/332,797 .filed. Jan. 17, 2006; U.S.
`
`patent application Set No. 12/509,362 filed Jul. 24, 2009; Ser. No. 12/469,365 filed May 20,
`
`2009 which is a continuation of U.S. patent application Ser. No. 111866„329 filed Oct. 2, 2007
`
`which claims priority to U.S. Provisional Patent Application Ser„ No. 60/848,72.0 filed Oct. 2,
`..006, and Ser. No. 12/469,625 .filed May 2.0. 2009 which is a. continuation of L.S. patent
`
`application. Ser. No. 11/866,329 filed Oct, 2, 2007 which claims priority. to C.S. Provisional
`
`Patent Application Ser. No. 60/848,720 tiled Oct. 2, 2006; and Ser. No. 12/509,304 filed Jul. 2.4,
`
`2009 Which is a continuation of U.S. patent application Ser. No. 12/508,529 filed Jul. 23, 2009
`
`which is a continuation-in-part of U..S. patent application Set No. 11/866,329 filed Oct 2, 2007
`
`Petitioner - Avation Medical, Inc.
`Ex. 1019, p. 1
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`

`

`Attorney Docket o,: ElvIKNNZ.00703
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`which claims priority::`ter U.S. PrOviSiOnal Patent Application Ser. No. 60/848,720 fi led Oct.
`2006:: and. Ser. No, 12/509,345 filed Jul. 24, 2€309 which is a continuation of U.S. patent
`
`application Ser. No. 12/508,529 filed. Jul. 23, 2009 which is a continuation-in-part of U.S. patent
`
`application. Ser. No. 11/866,329 filed Oct. 2, 2007 which claims prior€ty
`
`to U.S. Provisional
`
`Patent Application Ser. No. 60/848,720 filed Oct. 2, 2006.
`
`:1E1 D OF THE INVENTION
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`100031 The present apparatus and methods relate generally to energy emitting apparatus and
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`methods for providing a medical therapy. The apparatus and methods may prov€de
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`.for central and
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`peripheral nerve and other tissue modulation or stimulation therapies
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`7.KGROUND V THE 1 VENTIC.
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`[00041 The OAB and VI market in the United States
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`over a.S12..billion a year industry. It
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`affects over .6%: of alt Antericans for a total:US„ market of approximately 34..millionmen arm
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`women each year, Due to social stigmas attached to OAB and. W., as well as .misundepstanding of
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`the signs and symptoms. associated with OAB and tji, only 40% of those affected (13.6M) seek
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`treatment. Of those 13.6 million individuals, nearly 30% are unsatisfied with their current therapy.
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`100051 The use of pulsed electromagnetic stimulat€on (PES) has been well established as a
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`beneficial therapy in a variety of medical applications. The scientific principle behind this
`technology is that an electric. current. passed through a coil will generate an. electromagnetic f eld.
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`These fields, in turn, have been shown to induce current within conductive materials placed
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`within the field, When applied to the human body, pulsed electromzumetic stimulation has been
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`found to be an effective me€hod of stimulating nerves resting. w€thin the electromagnetic field.
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`Recent data highlights the beneficial effects of invasive, needle-based electrostimulation (ES) of.
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`the posterior tibial nerve in individuals with OAB and l 1. ES has been found to modulate bladder
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`dysfunction through its action. on the pudendal nerve and the sacral plexus which provides the
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`major excitatory input to the bladder.
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`Petitioner - Avation Medical, Inc.
`Ex. 1019, p. 2
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`Attorney Docket o,: ElvIKNNZ.00703
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`100061 (I
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`rent treatment options for OAB and U1 are exercise and behavioral modifications,
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`pharmacological therapies, surgical intervention, and neuromodulation. Although each of these
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`treatment options targets the i.f and OAB populations, each has severe l.im€tttions.
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`100071 Exercise and behavioral modifications often require patients to adhere to stringent
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`routines, including scheduled voiding, maintenance of a bladder diary, and. intense exercise
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`regiments. While this may be a viable option for a small group of highly dedicated individuals, its
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`daily impact on one's life makes it an unattractive opt€on for most individuals.
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`[.0008.1 Plutrinacological intervention is the most widely prescribed therapy for OAB and UL
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`Unfortunately, as with the inuestion of any chemical, patients are often subject to side effects
`from their drug therapy. This is espec€ally .detrimental in older and elderly patient populations
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`where interaction with other prescribed medications can have adverse effects. Further, there is a.
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`high rate of dissatisfaction, approximately 30%, amongst individuals using pharmacological
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`treatment
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`100091 Surgical intervention is an extremely invasive treatment and often results in the long e
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`and in some cases permanent, requirement for catheterization, The high expense of these
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`procedures, coupled with the negative impact the procedures have on the patients quality o
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`make this an option only when all other treatment options have been exhausted.
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`100.1.01 Neuromodulation is another treatment alternative for OAB and Ui patients. Sacral nerve
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`stimulation (SNS) has shown itself to he an effective treatment option for those with OAB or
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`However, the procedure requires the permanent implantation of an electrical stimulation device in
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`the patient. One estimate puts the cost at nearly $14,000 with additional routine care costs of $593
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`per patient per year. Additionally, SNS's risk of battery failure, implant infection, and electrode
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`migration, lead to a high reoperation rate and make this procedure unattractive.
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`100111 More recently, the introduction of a posterior tibial nerve stimulator, often referred to as
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`SANS, has shown itself to be another neuromodulation alternative. Yet as is the case with other
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`forms of neuromodulation, this system is invasive in its nature. it requires the insertion of a
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`needle two inches into the patient's ankle region in order to stimulate the posterior tibial nerve. As
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`well, it requires a minimum of 12 sessions for initial treatment, with the possibility of additional
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`sessions needed. for maintenance. Despite its high cost and invasive nature, though, an abundance
`
`Petitioner - Avation Medical, Inc.
`Ex. 1019, p. 3
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`

`

`of published peer-reviewed clinical trials demonstrate the safety and efficacy of the SANS
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`therapy,
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`Attorney Docket on ElYIKNNZ00703
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`SUMMARY
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`100121 in certain variations, a method for providing transdermal electrical stimulation therapy to a
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`patient is provided. The method may include positioning a stimulator electrode over a glabrous
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`skin surface overlying a target nerve of a subject. Electrical stimulation may be delivered through
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`or across the glabrous skin surface to the target nerve to stimulate the target nerve, while
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`remaining safe and tolerable to the patient. Electrical stimulation may be delivered at frequencies
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`that may be painful or intolerable when applied over non-glabrous surfaces of the body. The
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`electrical stimulation may be utilized to treat various conditions, e.g., urinary incontinence and
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`overactive bladder.
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`[00131 In certain variations, an applicator, e.g., an ergonomic applicator for providing
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`transdermal electrical stimulation therapy to a patien€ is provided. The applicator may be
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`configured to position a stimulator electrode over a glabrous skin surface of the subject to deliver
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`transdermal electrical stimulation through or across the glabrous skin surface to an unde_€'lying
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`target nerve, resulting in stimulation of the target nerve.
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`[00141 In certain variations, a method. for providing an energy based stimulation therapy to a
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`subject is provided. The method may include positioning an energy emitting device in proximity
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`to a glabrous surface overlying a target tissue. Energy may be delivered through the glabrous skin
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`surface to the target tissue to stimulate the target tissue.
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`100151 In certain variations, another method for providing an energy based stimulation. therapy to
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`a subject is proved. The method may include positioning an energy emitting device in proximity
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`to a skin surface overlying a target nerve. Energy may be delivered at a frequency of about Hz
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`to about 30 Hz through the skin surface to the target nerve, thereby generat€ng motor andlor
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`sensory nerve conduction of the target nerve while remaining safe and €olerable to the subje€..
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`Optionally, energy may be delivered at less than 10 Hz to generate nerve conduction.
`
`100161 in certain variations, systems for electromagnetic induction therapy may include one or
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`more conductive coils disposed within or along an applicator. The coils may be configured to
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`Petitioner - Avation Medical, Inc.
`Ex. 1019, p. 4
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`

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`Attorney Docket o,: EN4KNNZ00703
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`generate a:magnetic:field focused off
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`tat' et
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` muscle or other body tissues in proximity to.
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`the coil. One or more sensors may be utilized to detect electrical conduction in the target nerve, to
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`detect a muscular response caused by an electrical conduction in the target nerve, or to detect
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`stimulation of a. nerve, muscle or other body tissues and to provide feedback about the efficacy of
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`the applied electromagnetic .induction -therapy. A controller in communication with the sensor-
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`may be adjustable to vary a current through the at least one coil so as to adjust the magnetic field
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`focused upon the tarzge€ nerve, muscle or other body tissues. Optionally, a user or patient may
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`detect stimulation of a nerve, muscle or body tissue and. the therapy may be adjusted based on
`feedback from the user or patient.
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`[00171 1.11 certain variations, the applicator may be configured to intermittently apply or deliver
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`pulsed magnetic fields to a target nerve, muscle or tissue without causing hab€tuation of the target
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`nerve, muscle or tissue,
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`[00.181 1.11 certain variations, methods of electromagnetic induction therapy may include one or
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`more of the following steps. A first portion of a patients body maybe positioned relatiVeto or in.
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`proximity to an applicator or an applicator may be positioned relative to or in proximity to a first
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`portion of a patient's body, such that a target nerve, muscle or tissue within the first portion of the
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`body is in proximity to one or more conductive coils disposed .within or along the applicator. A
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`current may be passed through a coil to generate a magne€ic. field focused on the target nerve,
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`muscle or tissue, An electrical conduction through the target nerve, a. muscular response caused
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`by an electrical. conduction through the target nerve or stimulation of a nerve, muscle, or body
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`tissue may be detected by a sensor positioned along a second portion of the body. A signal from
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`the sensor indicative of the electrical conduction or stimulation. may be received, which provides
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`feedback about the efficacy of the applied electromagnetic induction therapy, The current may be
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`adjusted by a. controller in communication with the conductive coils based on the feedback.
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`[00191 Optionally, a user may detect stimulation of a nerve, muscle or body tissue and the therapy
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`may he adjusted based on feedback from the user. In certain variations, pulsed magnetic fields
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`may be intermittently applied or delivered a target nerve, muscle or tissue without causing
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`habituation of the target nerve, muscle or tissue, Such intermittent magnetic fields may he used to
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`treat chronic conditions, e.g., chronic pain, without causing habituation.
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`Petitioner - Avation Medical, Inc.
`Ex. 1019, p. 5
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`

`

`Attorney Dotket o,: EMKNNZ00703
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`100201 hi certain variations, applicatots may he ergonomic or may be designed or configured to
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`accommodate, approximate or be positioned relative to or in proximity to specific regions of the
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`body or anatomy. The specific regions of the body or anatomy may he positioned relative to the
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`applicators, or the applicators may be positioned relative to the specific regions of the body or
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`anatomy to treat various conditions, for example, osteoarthritis, arthritis, back or neck pain,
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`atrophy or paralysis, chronic pain, phantom or neuropathic pain, neuralgia, migraines, orthopedic
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`conditions.
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`0021.1 1..n one embodiment, the invention provides. a. method or device.. for providing transdermai.
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`electrical stimulation therapy to a subject including positioning a stimulator electrode over a
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`glabrous skin surface overlying a palm of the subject and delivering electrical stimulation via a
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`pulse generator transdermally through the glabrous skin surface and to a target nerve or tissue
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`within the hand to stimulate the target nerve or tissue within the hand so that pain. felt by the
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`subject is mitigated. The pulses generated during the electrical stimulatio€'t therapy may include
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`pulses of one or two or more different magnitudes.
`
`100221 in some embodiments, the electrical stimulation is delivered at a frequency of about 5 Hz
`to, about 60 HA while remaining safe and tolerable to the subject. In some embodiments, €he
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`stimulator electrode is a surface electrode. The electrical stimulation may be delivered
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`intermittently or on a chronic basis_
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`[00231 in some embodiments, the device includes a sensor (which may be a surface electrode, or
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`other type of electrode) for detecting nerve stimulation which receives a signal from the sensor
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`indicative of the detected electrical stimulation thereby providing a feedback about the efficacy of
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`the .applied. electrical stimulation therapy such that the therapy is adjusted or optimized. An M-
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`wave and/or F-wave may be detected by the sensor. A parameter of the M-wave and/or F-wave
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`may be displayed to the subject.
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`[00241 In some embodiments, the feedback is queried by .aVontroller such that the electrical
`stimulation. therapy is adjusted to ensure that a minimum amount of etiergyiS. beiag applied to
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`stimulate the target nerve within the hand while reducing the risk of burns or intolerance.
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`Alternatively, the feedback may be queried such that the positioning of the stimulator electrode is
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`adjusted to. optimize the electric& stimulation therapy.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1019, p. 6
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`

`

`Attorney Dobkint 0.: EN4KNNZ.00703
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`[00251 In .soine embodiments„ateturn elOcttOde may be posi€ioned on the subject to facilitate
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`penetrat€on of an elec€rical. current throuuh the glabrous surface €o stimulate the €arse€ nerve
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`within the hand. The stimulator electrode may be attached. to the glabrous skin surface with an
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`adhesive. The stimulator electrode may be positioned over the glabrous skin surface with an
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`ergonomic applicator. The applicator may be a glove or brace configured to be positioned against
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`the palmar surface of a hand such that the electrode delivers electrical stimulation to a target nerve
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`within the hand.
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`[00261 In sonic embodin ents, the electrical stimulation is automatically paused for a proSett
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`amount of time every 10 minutes to overcome habituation, In some embodiments, the electrical
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`stimulation. is automatically paused .tor a preset amount of time every 10 minutes based on
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`feedback provided by a sensor regarding target nerve stimulation or habitua€ion..
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`100271 In some embodiments, once tetany is detected. in a patient, indicating that a threshold
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`frequency of the applied stimulation has been reached, the strength of the applied stimulation .€s
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`automatically or manually decreased.
`
`100281 In some embodiments, electrical stimulation is pmvided by delivering a cycle comprising
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`a preset number of pulses followed by a pause in stimulation, followed by a preset number of
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`pulses, and repeating the cycle as necessary.
`
`[00291 in some embodiments, the device is used to treat migraine pain..
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`[00301 Other features and advantaees will appear hereinafter. The features and elements
`
`described herein can he used separately or together, or in various combinations of one or more of
`
`them.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`1100311 The drawings constitute a part of this specification and include exemplary embodiments of
`
`the invention, which may be em.bodied in various forms. It is to be understood that in some
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`instances various aspects of the embodiments may be shown exaggerated or enlarged to facilitate
`
`an understanding of the embodiments.
`
`100321
`
`I is a schematic view of an apparatus for magnetic .induction therapy according to a
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`first variation.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1019, p. 7
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`

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`Attorney Docket No..: EVIKNNZ00703
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`100331 no. 2 is a schematic view of an apparatus for magnetic induction therapy according to a
`second variation.
`
`[00341 FIG_ 3 is a scher atic view of an apparatus -fOr magnetic inductiOn €herapy according to a
`
`third variation.
`
`[00351 FIG. 4 is a schematic view of an apparatus for magnetic induction therapy according to a
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`:With variation.
`
`
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`[00361 FIG. 5 is a schematic. view of an apparatus for magnetic i€z - induction therapy according to a
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`fifth variation.
`
`100371 FIGS. -6 -6D are schematic illustrations depicting a first method of use of an apparatus for
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`magnetic induction therapy. This method is bas€.d on adjusting the position of the conductive coils
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`so to optimize a magnetic flow applied to a target nerve.
`
`100381 FIGS. 7A-7D are schematic illustration$ of a second method of use of .an apparatus for
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`magnetic induction therapy. This method is based on locidng the conductive coils in position once
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`electrical conduction in a target nerve has been detected_
`
`[00391 FIG. 8 is a schematic view of a. variat.ion that includes a plurality of sensors.
`
`100401 FIGS. 9A-9D are schematic representations of different garments adapted to operate as
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`apparatus for magnetic induction therapy.
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`[0041.1 FIG_ 10 is a schematic. view of an apparatus for providing electrical stimulation.
`
`[00421 FIG. 11 is a schematic view of another variation of an appara€ifs for providing electrical
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`stimulation.
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`[00431 1 FIG. 12 shows a. schematic view of an energy emitting system inc hiding a microneedle
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`patch sensor.
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`100441 FIG. 13-15 shows magnified. bottom views of variations of microneedle patches.
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`[0045j FIGS. 16-1.7 showsmagnified_ side views of variations of a microneedle patch.
`
`[00461 FIG. 18 shows a magnified bottom per pective view of a microneedle patch_
`
`[{li}47} FIG. 19 shows a representative cross sectional view of the skin composed of an out
`stratum contemn covering the epidermal and dermal layers of skin and the underlying
`
`subcutaneous tissue, with a variation of a microneedle patch a.t€ached thereto.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1019, p. 8
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`

`

`Attorney Doeket o,: EMKNNZ00703
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`100481 140. 20a shows a magnified side view of a variation of a microneedle patch includ
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`multiple electrodes,
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`(00491 FIG. 20b-201) show variations of a microneedle patches including multiple elec€rodeS.
`
`[00501 FIG. 21 shows a schematic view of an energy emitting system including a microneedle
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`patch sensor placed behind a subject's knee.
`
`[00511 FIGS. 22-23 show schematic iews of energy emitting systems it c.:lud.ra an electrode
`needle and sensor.
`
`100521 FIGS. 24-25 show schematic views of energy em€tting systems including an electrode
`needle without a sensor.
`
`100531 FIG. 26 shows a schematic view of an energy emitting.Vstem. including a mic
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`eedle
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`patch for providing stimulation.
`
`[00541 FIGS. 27-28 show schematic views of energy en " ing systems including an electrode
`needle and microneedle patch for providing stimulation.
`
`[00551 FIG. 29a-29d show a prospective, side, top and rear views of an energy emitting device in
`the form of a foot cradle.
`
`[00561 FIGS. 30a-301) show schertlatie views of an energy emitting device i t the form of a knee
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`support
`
`[00571 F GS. 31a-3 lb shows a schematic view of a variation f an arm applicator and a foot,
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`knee or leg applicator.
`
`100581 FIG. 32 shows a schematic view of a variation of a back applicator.
`
`[00591 FIG_ 33 shows a schematic. view .01a. variation of a system including a back: applicator,
`sensor and logic controller.
`
`[00601 FIG. 34 shows a schematic view of system including multiple back.applicaters, a sensor
`and logic controller,
`
`[00611 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
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`controller.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1019, p. 9
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`

`

`Attorney Docket o,: ElvIKNNZ.00703
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`100621 FIG. 36 shows a schematic viewOf a variation of an applicator designed to stimulate a
`nerve responsible fbr phantom or neuropathic pain.
`
`100631 FIG. 37 shows a. schematic view of a variation of a facial neuralgia applicato
`
`[00641 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.
`
`100651 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.
`
`100661 FIG. 40 shows a schematic view of a variation an applicator in the form of a stimulator
`coil platform for positioning o.€ze or more coils in proximity to a knee or popliteal nerve.
`
`100671 FIG. 41 shows a schematic view of a system including, a variation of a back applicator
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`held. on a patient's body by an ergonomic positioning element in the form of a Shoulder harness, a
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`sensor, and a logic controller.
`
`100681 FIGS. 42A and 4213 show an example of how the amount of stimulator poipower required to
`
`achieve a desired stimulus may be automatically adjusted as a result of fibroses.
`
`[0069] FIGS. 43A. a and 4313 show variations afa coil device positioned. on at skull.
`
`100701 FIG. 44 shows a view of the underside or glabrous surface of the foot and exemplary sites
`
`for delivering electrical stimulation.
`
`100711 :FIG. 45 shows a perspective view of one variation cif an insole for delivering electrical
`stimulation over a glabrous surface of the foot..
`
`100721 FIG. 46 shows a perspective view of a variation of an insole for delivering electrical
`stimulation over a glabrous surface of the foot, inch€ding' a. sensor feedback feature.
`
`100731 FIG. 47 shows a. perspective view of one variation of electrodes for delivering elect a
`
`stimulation over a glabrous surface of a foot.
`
`100741 FIG. 48 shows a perspective view of one variation of a has.€ d aapplicator ibt del iverinQ
`
`electrical stimulation over a glabrous surface of a hand.
`
`[00751 FIG. 49 shows a perspective, view of one variation of electrodes for delivering electrical
`
`stimulation over a. glabrous surface of a hand.
`
`[00761 FIG. 50 shows an exa I le of an EMG reading,.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1019, p. 10
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`

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`Attorney Docket o,: EMKNNZ00703
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`[00,71 FIG .51A shOWS, the,anteriOr of palmy
`
` of the forearm and the Tina nerve.
`
`100781 FIG, 51 B shows the anterior view of the cutaneous distribution of the tilnar nerve.
`
`[00791 FIG. 51C shows the posterior view of the cutaneous distribution of the Ulnar nerve.
`
`100801 Fla 52 shows a :lose up view of the Ulnar nerve and its branches including the palmar
`
`branch.
`
`[posi 1 FIG. 53 shows a close tap palmar view of tyre palma.r branch of the
`
`I
`
`nerve including
`
`the area of sensation.
`
`[00821 FIG. 54A shows an anterior view of theMedian nerve of the forea.r.€rr
`
`Median nerve's palmar branch.
`
`[00831 FIG. 54B shows the anterior or palmar view of the Median nerve's Cutaneous innervation.
`
`100841 FIG. 54C shows the posterior or dorsal view of the Median nerve's cutaneous innervation,
`
`[00851 FIG. 55 shows a close up anterior or palmar view of the Median nerve's palmar branch in
`
`the hand and its area of sensation.
`
`[00861 FIG. 56A. shows the anterior iiew of the forearm including the Median an
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`I.iln,ar a
`
`their respective palmar branches.
`
`[00871 FIG. 56B shows the anterior or pat
`
`view:and. thepogeriorordorsal view of th
`
`distribution of the cutaneous nerves.
`
`100881 FIGS. 56C-56F show branches of the Tibial nerve,: electrode placement and innervation of
`
`the plantar portion of the foot,
`
`100891 FIG. 57 is a diagram showing a mapping of the
`
`nan cortex as laid out against the
`
`various lobes.
`
`[00901 FIGS, 58, 59A and 59B illustrate how di.ff€Yrent areas of the human body take u
`
` rent
`
`cortical "real estate' of the somatosensory cortex.
`
`[00911 FIG, 60A shows an exploded view of the external generator or controller that can be used
`
`in some embodiments of the present invention.
`
`[00921 FIG. 60B shows the external generatorlcontroller ire FIG. 60A m a not -exploded view.
`
`100931 FIG. 60C shows another embodiment of a generator controller.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1019, p. 11
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`Attorney Docket o,: EMKNNZ00703
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`100941 Fla, 60) shOWS, fOitit exemplary patch electrodes that are suitable to use with the present
`invention.
`
`[00951 FIG, 61A shows electrodes designed for the pmilmar suilice of the hands along with FM
`
`wave detectino. electrodes.
`
`[00961 FIGS. 618-61G show electrodes with different. types
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` stimulating different ner
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`[00971 FIG. 62 shows a pulse train of one embodiment,
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`[0098.1 FIG, 63 shows an M—Wave and F.-Wave display.
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`[0099( FIG. 64 shows results from a migraine study.
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`101001 FIG. 65 is a block diagram of a data processing system.
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`DETAILED DESCRIPTION
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`101011 In certain variatio s, various apparatus and methods for providing magnetic induction
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`therapy or electrical stimulation therapy are provided. In certain variations, various apparatus and
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`methods may provide for central and peripheral nerve and other tissue modulation or stimulation
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`therapies, including both excitation and blocking of nerve impulses. In certain variations, a low
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`frequency induction therapy may be perlbrined. In certain variations, these apparatus and methods
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`may be useful in the treatment and prevention of urinary incontinence tUI), overactive bladder
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`(0A13) and other conditions.
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`[01021 In certain variations, apparatus and methods for magnetic induction therapy, in which
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`dosage of magnetic energy can be regulated according to conduction in a target nerve exposed to
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`the magnetic field are provided.
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`10103} In certain variations, apparatus and methods for magnetic induction €her'apy, in which the
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`flow of magnetic energy can be adjusted directionally by the patient or a healthcare provider
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`\•Yrthoirt altering the position of a housing containing conductive coils that produce the magnetic
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`field are provided.
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`101041 In certain variations, apparatus and methods for treating a variety of ailments by
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`providing energy to a target nerve, for example magnetic energy, electrical energy or ultrasound
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`Petitioner - Avation Medical, Inc.
`Ex. 1019, p. 12
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`

`

`Attorney Docket o,: ElvIKNNZ00703
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`energy, at a location and in an, amount optimized by detecting conduction in the target nerve are
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`provided.
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`101051 In certain variations, an energy emitting apparatus for. delivering a. medical therapy that
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`includes one or more energy generators, a logic controller electrically connected to the one or
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`more energy generators, and one or More sensors for detecting electric conduction in a target
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`nerve, which are connected to the logic controller is provided. The one or more energy
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`generators produce energy f=ocused on the target nerve upon receiving a signal from. the logic
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`controller, and the applied energy is varied by the logic controller according to an input provided
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`by the one or more sensors based on electric conduction in the target nerve. The feedback
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`provided by the sensors to the logic controller about the efficacy of the applied treatment causes
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`the logic controller to modulate the current transmitted to the coils.
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`[0:1061 The applied energy may be a magnetic field, an electrical field, an ultrasound, a visible
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`light, or an infrared or an ultraviolet energy. When a magnetic field is applied., the energy.
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`emitting device is an apparatus that provides a magnetic induction therapy and that includes one
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`or more conductive coils disposed in an ergonomic housing. A logic controller is electrically.
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`connected to the one or more coils, and one or more sensors detect electric conduction in the
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`target nerve and are connected to the logic controller so to provide a feedback to the logic
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`controller, The conductive coils receive an electric current from the logic controller and produce
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`a magnetic field focused on a target nerve, and the electric. current fed b the logic controller is
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`varied by the logic controller according to an input provided by the sensors, thereby causing
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`amplitude, frequency or direction of the magnetic field, or the firing sequence of the one or more
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`coils, to be varied according to the efficiency of the treatment provided to the target nerve.
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`certain variations, the housing containing the conductive coils may be a flexible wrap, a cradle or
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`a garment, and the coils .may' be overlapping and/or- be disposed in different positions within the
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`housing, so to generate a magnetic field on different body parts with the desired direction and
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`amplitude.
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`101071 The one or more coils may be stationary .or movable within the housing, making it
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`possible to optimize the direction of magnetic flow to the target nerve by disposing the coils in
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`the most effective direction, In different variations, the coils may be movable manually by acting
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`on a knob, lever, or similar type of actuator, or may be translated automatically by the logic
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`Petitioner - Avation Medical, Inc.
`Ex. 1019, p. 13
`
`

`

`Attorney Docket o,: EMKNNZ00703
`
`•
`•
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`controller in response.tathe input provided by the sensors. When a preferred position for the
`cods has been established, the coils tnay be locked in posjtion and maintain that position during
`successive therapy sessions, in other variations, the sensors may be incorporated within the
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`housing, or instead may be disposed on a body part of interest independently of the housing.
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`[01081 .in still other variations, the inductive cods are disposed in a housing that is situated
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`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
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`activate an implantable device. In yet other variations, the electric current may varied b the
`logic controller both on the basis of an input provided by the one or more sensors and also an
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`input provided by the patient according to a muscular response she has perceived, for example,
`the twitching of .a toe after application of the magnetic field_
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`1x109.1 In yet other variations, the source of energy for nerve stimulation may be electrical
`enemy and nerve conduction may be detected at a site sufficiently distant from the site of
`stimulation., so to enable detection of nerve conduction despite any interference from the direct
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`electrical stimuli. In these variations, direct electrical sti