Title: METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY
`inventor(s): Daniel Rogers BURNETT et al.
`Application No.: Not Yet Assigned
`Attorney Docket No.: EMKNNZGO301
`
`24
`30
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`22
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`26
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`20
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`FIG. 1
`
`36
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`FIG. 2
`
`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 1
`
`

`

`Title: METHOD AND APPARATUS FOR MAGNETIC INDUCT€ON THERAPY
`inventor(s): Daniel Rogers BURNETT et al.
`AppHeaton No.: Not Yet Assigned
`Attorney Docket No.: EMKNNZ00301
`
`A
`
`FIG. 3
`
`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 2
`
`

`

`Title: METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY
`Inventor(s): Daniel Rogers BURNETT et al.
`Application No.: Not Yet Assigned
`Attorney Docket No.: EMKNNZQQ3₹31
`
`50
`
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`
`58
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`66
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`FIG. 5
`
`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 3
`
`

`

`Title: METHOD AND APPARATUS FOR MAGNET€C INDUCTION THERAPY
`inventor(s): Daniel Rogers BURNETT et al.
`Application No.: Not Yet Assigned
`Attorney Docket No.: EMKNNZ00301
`
`CO
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`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 4
`
`

`

`Title: METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY
`Inventor(s): Daniel Rogers BURNETT et al.
`Application No.: Not Yet, Assigned
`Attorney Docket No.: EMKNNZ00301
`
`CO
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`
`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 5
`
`

`

`Title: METHOD AND APPARATUS FOR MAGNETIC INDUCT€ON THERAPY
`inventor(s): Daniel Rogers BURNETT et al.
`AppHeaton No.: Not Yet Assigned
`Attorney Docket No.: EMKNNZ00301
`
`96
`
`FIG. 8
`
`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 6
`
`

`

`Title: METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY
`inventor(s): Daniel Rogers BURNETT et al.
`Application No: Not Yet Assigned
`Attorney Docket No.: EMKNNZ00301
`
`CO
`
`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 7
`
`

`

`Title: METHOD AND APPARATUS FOR N£ACNETiC INDUCTION THERAPY
`Inyentor(s): Daniel Rogers BURNETT et al.
`Application No.: Not Yet Assigned
`Attorney Docket No.: EMKNNZ00301
`
`128
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`130
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`138
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`FIG. 10
`
`136
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`126
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`FIG. 11
`
`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 8
`
`

`

`Title: METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY
`inventor(s): Daniel Rogers BURNETT et al.
`Application No.: Not. Yet Assigned
`Attorney Docket No: EMKNNZ00301
`
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`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 9
`
`

`

`Title: METHOD AND APPARATUS FOR MAGNETIC iNDUCTION THERAPY
`Inventor(s): Daniel Rogers BURNETT et a€.
`Application No.: Not Yet Assigned
`Attorney Docket No.: EMKNNZ00301
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`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 10
`
`• .....
`

`

`Title: METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY
`Inyentor(s): Daniel Rogers BURNETT et al.
`Application No.: Not Yet Assigned
`Attorney Docket No.: EMKNNZQQ3₹31
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`Ex. 1047, p. 11
`
`

`

`Title: METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY
`Inventor(s): Daniel Rogers BURNETT et al.
`Application No.: Not Yet Assigned
`Attorney Docket No.: EMKNNZ00301
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`Ex. 1047, p. 12
`
`

`

`Title: METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY
`Inyentor(s): Daniel Rogers BURNETT et al.
`Application No.: Not Yet Assigned
`Attorney Docket No.: EMKNNZ0030:1
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`Ex. 1047, p. 13
`
`

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`Title: METHOD AND APPARATUS FOR MAGNETIC iNDUCTiON THERAPY
`Inventor(s): Daniel Rogers BURNETT et al.
`Application No.: Not Yet Assigned
`Attorney Docket No.: EMKNNZ00301
`
`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 14
`
`

`

`Title: METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY
`inventor{s}: Daniel Rogers BURNETT et al.
`Application No.: Not Yet Assigned
`Attorney Docket No.: Erv1KNNZ003D1
`
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`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 15
`
`

`

`Title: METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY
`Inventor(s): Daniel Rogers BURNETT et al.
`Application No.: Not Yet Assigned
`Attorney Docket No.: EN1KNNZ00301
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`Ex. 1047, p. 16
`
`

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`Tide: METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY
`Inventor(s) Daniel Rogers BURNETT et al.
`Application No.: Not Yet Assigned
`Attorney Docket No.: EMKNNZ00301
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`Ex. 1047, p. 17
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`

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`Title: METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY
`Inyentor(s): Daniel Rogers BURNETT et al.
`Application No.: Not Yet Assigned
`Attorney Docket No.: EMKNNZ00301
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`Ex. 1047, p. 18
`
`

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`Title: METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY
`Inventor(s): Daniel Rogers BURNETT et al.
`Application No.: Not Yet Assigned
`Attorney Docket No.: EMKNNZ00301
`
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`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 19
`
`

`

`Title: METHOD AND APPARATUS FOR MAGNETIC lNDUCTiON THERAPY
`Inventor(s): Daniel Rogers BURNETT et al.
`Application No.: Not Yet Assigned
`Attorney Docket No: EMKNNZ00301
`
`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 20
`
`

`

`Title: METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY
`Inyentor(s): Daniel Rogers BURNETT et al.
`Application No: Not Yet Assigned
`Attorney Docket No.: EMKNNZ00301
`
`Cm.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 21
`
`

`

`Title: METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY
`Inventor(s): Daniel Rogers BURNETT et al.
`Application No: Not Yet Assigned
`Attorney Docket No: EMKNNZ00301
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`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 22
`
`

`

`Title: METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY
`Inventor(s): Daniel Rogers BURNETT et al.
`Application No: Not Yet Assigned
`Attorney Docket No.: EMKNNZ00301
`
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`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 23
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`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 24
`
`

`

`METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY
`
`Atterney Docket No?..EMKNNZ00301
`
`CROSS-REFERENCE TO. RELATED APPLICATIONS
`
`The`present application is a continuation-in-part of U.S. Patent Application Serial
`100011
`5 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 which is incorporated herein by reference in its
`entirety.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`[0002]
`
`[0003]
`
`BACKGROUND
`Overactive bladder ("OAB") and urinary incontinence ("UT") affect over 16% of the
`American population each year, or approximately 34 million men and women. Outside of the United
`States, OAB and Ul affects over 46 million Europeans. The economic cost of OAB and UI is
`estimated to be in access of $12 billion a year in the United States alone.
`Due to the social stigmas attached to OAB and UI and to misunderstandings related
`to the symptoms associated with OAB and UI, only 40% of the affected individuals in the United
`States seek medical treatment. Of those 13.6 million Americans seeking medical treatment, nearly
`30% or 4 million individuals are reportedly unsatisfied with their current therapy.
`[0004]
`Known treatments for OAB and UI include exercise and behavioral modifications,
`pharmacological therapies, surgical intervention and neuromodulation, but each of these treatments
`exhibits severe limitations.
`
`[0005]
`Exercise and behavioral modifications often require patients to adhere to stringent
`routines, including scheduled voiding, maintenance of a bladder diary, and intense exercise
`regimens. While this type of treatment may be a viable option for a small group of highly dedicated
`individuals, its daily impact on a person's life makes it unattractive for most patients.
`[0006]
`Pharmacological intervention is the most widely prescribed therapy for OAB and
`UI. Unfortunately, patients often suffer front side effects related to their drug therapies. Such side
`effects arc sometimes serious and arc particularly pronounced in elderly patient populations that tend
`to use a plurality of medications. In addition, approximately 30% of all patients subjected to
`pharmacological therapies appear to be dissatisfied with the efficacy of their prescribed treatments.
`[0007]
`Surgical intervention IS extremely invasive and often results in a long-term
`requirement for catheterization that may become permanent in some instances. The negative impact
`of these procedures on the patient's quality of life and their high expense make surgical intervention
`a recommended option only when all other treatment options have been exhausted.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 25
`
`

`

`Attorney Docket No.: EMKNNZ00301
`
`5
`
`100081
`Neuromodulation is another available therapy for OAB and Ul. In general, pulsed
`electromagnetic stimulation ("PES") has proven to have beneficial effects in a variety of medical
`applications. The related scientific principle is that an electric current passing through a coil
`generates an electromagnetic field, which induces a current within a conductive material placed
`inside the electromagnetic field.
`100091
`
`More particularly, PES has been shown to be an effective method of stimulating a
`nerve positioned within the electromagnetic field, thereby affecting a muscle controlled by that
`nerve. For example, in the paper titled "Contactless Nerve Stimulation and Signal Detection by
`Inductive Transducer" presented at the 1969 Symposium on Application of Magnetism in
`10 Bioengineering, Maass et al. disclosed that a nerve threading the lumen of a toroid could be
`stimulated by a magnetic field of 0.7 Volt peak amplitude and a 50 µs duration in a monitor wire,
`and that such stimulation could generate a contraction of major leg muscles in anesthetized
`mammals.
`
`15
`
`100101
`Various attempts were made in the prior art to use PES for treating a variety of
`ailments. For example, U.S. Patent No. 4,548,208 to Niemi discloses an apparatus for inducing bone
`growth by generating an electric current in the body through the external application of an
`electromagnetic field. Such apparatus includes opposing clamps disposed on a limb and may
`optionally include feedback coils and a microprocessor for sensing the magnetic field, so to avoid an
`overcurrent mode. Therefore, this apparatus optimizes the magnetic field on the basis of
`20 measurements of the generated magnetic field.
`100111
`U.S. Patent No. 4,940,453 to Cadwell discloses a method and apparatus for
`magnetically stimulating the neural pathways of a higher level organism. In this invention, a
`sinusoidally fluctuating current flow is created through a coil that overlies neurons to be stimulated,
`and frequency of the current flow and frequency of the magnetic field produced by the coil
`predetermined to correspond to the time constant of the neurons to be stimulated. Sensors for sensing
`coil conditions, such as coil temperature, may also be included.
`100121
`U.S. Patent No. 5,000,178 to Griffith discloses an electrical to electromagnetic
`transducer for applying electromagnetic energy to damaged parts of a living body by directing
`electromagnetic radiation to a certain damaged body part. Electromagnetic radiation is initially
`generated by a dipole consisting of a bar of high permeability material wrapped with an electrically
`conductive coil. Magnetic fields, which are generated away from the damaged body part, intersect a
`conductive shield and establish eddy currents, which in turn generate magnetic fields opposite and
`nearly equal to the magnetic fields generated by the electromagnetic source. The resultant
`
`25
`
`30
`
`2
`
`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 26
`
`

`

`Attorney Docket No:: EMKNNZ00301
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`electromagnetic fields reinforce the electromagnetic field directed towards the damaged body part
`and diminish the electromagnetic field directed away from the damaged body part.
`U.S. Patent No. 5,014,699 to Pollack et al. discloses a non-invasive, portable
`[0013]
`electromagnetic therapeutic method and apparatus for promoting the healing of damaged or diseased
`living tissue, including fractured bone. These method and apparatus involve generating a signal that
`has a series of substantially symmetric voltage cycles of bursted pulses with narrow pulse widths of
`0.5 to 20 microseconds, and further involve converting the signal into an electromagnetic field
`extending into an area that contains tissue to be healed. This invention provides for no feedback on
`the efficiency of the applied stimulation.
`In a paper titled "Selective Stimulation and Blocking of Sacral Nerves: Research
`[0014]
`Setup and Preliminary Results," published in Annual International Conference of the IEEE
`Engineering in Medicine and Biology Society, Vol. 13, No.2, 1991, Wijkstrda et al. used an external
`pulsed magnetic coil to stimulate a peripheral nerve for the treatment of urinary incontinence. The
`authors used a large magnetic field produced by a single coil to ensure that the nerve was fired and
`the resulting nerve conduction was frequently painful or intolerable. In addition, coil alignment was
`problematic because an internally implanted coil was utilized, which had to be aligned with the fully
`external magnetic field to stimulate the nerve. Due to the difficulty in positioning the device, the
`practical application of this therapy does not permit home healthcare usage without a preset
`alignment and monitoring of the nerve, and no provision was made to insure that the nerve was
`actually being stimulated or to adjust the device in response to commonly occurring physiologic and
`anatomic variations in nerve locations.
`U.S. Patent Nos. 5,181,902 Erickson et al. and 5,314,401 to Tepper:disclose pulsed
`[0015]
`electromagnetic field ("PEMF") transducer systems usable to perform PEMF therapies (such as after
`spinal fusion) by generating flux-aided electromagnetic fields. The drive electronics includes a
`PEMF processor that executes a PEMF program for controlling the activation of the electromagnetic
`fields (field strength and cycle).
`In a paper titled: "Magnetic Stimulation of the Bladder in Dogs" presented at the
`[0016]
`1993 AAEM Annual Meeting, the abstract of which was published in the Muscle & Nerve issue of
`October 1993, Lin et al. disclosed that magnetic stimulation could be employed to stimulate the
`cortex, spinal nerves and peripheral nerves of dogs through direct trans-abdominal stimulation of the
`detrusor muscles or through stimulation of the lumbosacral roots.
`As shown, the prior art makes no provision to measure the efficacy of PES
`[0017]
`treatment, causing patients to be treated improperly, either by an insufficient or excessive exposure
`to PES. Other attempts to monitor PES dosage in the prior art exhibit serious drawbacks. For
`
`3
`
`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 27
`
`

`

`Attorney Docket No.:'EMKNNZ00301
`
`example, U.S. Patent No. 5,518,495 to Kot discloses an apparatus for the treatment of arthritis
`utilizing a magnetic field therapy, which includes an adjustable voltage source that is connected to a
`source of line voltage and a coil connected to the adjustable voltage source. This apparatus has no
`feedback system to advise a healthcare provider of the efficiency of the treatment.
`[0018]
`
`U.S. Patent No. 5,984,854 to Ishikawa et al. discloses a method for treating urinary
`
`incontinence based on delivering a train of current pulses through one or more magnetic stimulation
`coils so to induce a train of magnetic flux pulses, which then induce an eddy current within the body
`and stimulates a group of pelvic floor muscles, the pudendal nerve, the external urethral sphincter, or
`the tibial nerve. While this method includes the use of pulsed electromagnetic for treating urinary
`incontinence, no specific components are envisioned to facilitate the placement of the magnetic coils
`over a targeted region of the body or a system for monitoring the efficiency of the therapy being
`applied.
`
`[0019]
`
`U.S. Patent No. 6,086,525 to Davey et al. discloses a magnetic nerve stimulator that
`includes a core constructed from a material having a high field saturation having a coil winding
`disposed thereon. A thyrister capacitive discharge circuit pulses the device, and a rapidly changing
`magnetic field is guided by the core, preferably made from vanadium permendur.
`
`[0020]
`
`[0021]
`
`U.S. Patent No. 6,701,185 to Burnett et al. also discloses an electromagnetic
`stimulation device that includes a plurality of overlapping coils, which can be independently
`energized in a predetermined sequence such that each coil will generate its own independent
`electromagnetic field and significantly increase the adjacent field. Unfortunately, none of these
`patents provides a system for monitoring the efficiency of the therapy in progress, either with respect
`to the proper positioning of the winding over the area to be treated or of the intensity of the magnetic
`field to be applied.
`Other PES therapies require the implantation of devices into the patient, with the
`consequent discomfort, risk and cost to the patient. For example, U.S. Patent No. 6,735,474 to Loeb
`et al. discloses a method and system for treating U1 and/or pelvic pain by injecting or
`laparoscopically implanting one or more battery-or radio frequency-powered microstimulators that
`include electrodes placed beneath the skin of the perineum and/or adjacent the tibial nerve.
`U.S. Patent 6,941,171 to Mann ct al. describes a method and a system for treating
`[0022]
`incontinence, urgency, frequency, and/or pelvic pain that includes implantation of electrodes on a
`lead or a discharge portion of a catheter adjacent the perineal nerve(s) or tissue(s) to be stimulated.
`Stimulation pulses, either electrical or drug infusion pulses, arc supplied by a stimulator implanted
`remotely through the lead or catheter, which is tunneled subcutaneously between the stimulator and
`stimulation site.
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`4
`
`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 28
`
`

`

`Attorney Docket No;:.-EMICNNZ00301
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`[0023]
`Other PES therapies in the prior art involve the use of electrodes placed on or
`beneath the skin of a patient. Recent data on invasive, needle-based PES of the posterior tibial nerve
`in individuals with OAB and UI indicates that PES can modulate bladder dysfunction through its
`action on the pudendal nerve and the sacral plexus, which provide the major excitatory input to the
`bladder.
`
`[0024]
`
`In a paper titled "Percutaneous Tibial Nerve Stimulation:via Urgent OD PC
`Neuromodulation System -An Emerging Technology for managing Overactive Bladder," which was
`published in Business Briefing: Global Surgery 2004, CystoMedix, Inc. disclosed that peripheral
`tibial nerve stimulation ("PTNS") had been found effective in treating OAB. The disclosed
`procedure involved the use of electrode and generator components, including a small 34-gauge
`needle electrode, lead wires and a hand-held electrical generator. However, the procedure requires
`the permanent implantation of an electrical stimulation device in the patient. One estimate put the
`cost of treatment at nearly $14,000 with additional routine care costs of $593 per patient per year.
`Additionally, risks of battery failure, implant infection, and electrode migration led to a high re-
`operation rate and made this procedure unattractive.
`[0025]
`U.S. Patent No. 7,117,034 to Kronberg discloses a method for generating an
`electrical signal for use in biomedical applications that includes two timing-interval generators. In
`this invention, skin-contact electrodes may be placed over an area of interest and a microprocessor
`may direct timing and sequencing functions, although such timing and sequencing functions arc not
`related to the actual efficacy of the treatment while treatment is being performed.
`[0026]
`U.S. Patent Application Publication No. 2005/0171576 to Williams et al. discloses
`an electro-nerve stimulation apparatus that includes a pulse generator, a first electrically conductive,
`insulated lead wire, a second electrically conductive, insulated lead wire, an electrically conductive
`transcutaneous electrode and an electrically conductive percutaneous needle electrode. Connected to
`one end of the first and second lead wires is a connector for electrically coupling with the pulse
`generator. In this invention, a percutaneous needle electrode is inserted through the skin in proximity
`to the desired internal stimulation site and electric stimulation is employed, rather than pulsed
`electromagnetic stimulation. Moreover, the Williams invention does not contemplate mechanisms
`for facilitating use of the device by an untrained user, nor a monitoring of the applied therapy.
`[0027]
`A neuromodulation alternative is a posterior tibial nerve stimulator, often referred to
`as SANS, but as is the case with other forms of neuromodulation, this procedure is invasive in nature
`and requires the insertion of a needle five centimeters into the patient's ankle region to stimulate the
`posterior tibial nerve. This procedure also requires a minimum of twelve sessions for initial
`treatment, possibly with additional sessions required for maintenance.
`
`5
`
`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 29
`
`

`

`Attorney Docket No.: EMICNNZ00301
`
`100281
`Also, therapies involving the use of traditional insertable or implantable
`pereutaneous needles require penetration into deeper tissues'and carry with them the added risk of
`infection, while causing pain and discomfort to the patient, This often results in ineffective treatment
`and or reduced patient compliance.
`
`SUMMARY
`[0029]
`In certain embodiments, 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.
`[0030]
`In certain embodiments, 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.
`
`[0031]
`In certain embodiments, 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.
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`[0032]
`In certain embodiments, 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.
`[0033]
`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
`30 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
`
`6
`
`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 30
`
`

`

`Attorney Docket No.: EMKNNZ00301
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`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 embodiments, 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.
`[00341
`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 embodiments, the coils may be movable manually by acting on
`a knob, lever, or similar type of actuator, or may be translated automatically by the logic controller in
`response to the input provided by the sensors. When a preferred position for the coils has been
`established, the coils may be locked in position and maintain that position during successive therapy
`sessions. In other embodiments, the sensors may be incorporated within the housing, or instead may
`be disposed on a body part of interest independently of the housing.
`[00351
`In still other embodiments, 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 embodiments, the electric current may varied by the logic
`controller both on the basis of an input provided by the one or more sensors and also an input
`provided by the patient according to a muscular response she has perceived, for example, the
`twitching of a toe after application of the magnetic field.
`[00361
`J
`In yet other embodiments, the source of energy for nerve stimulation may be
`electrical energy and nerve conduction may be detected at a site sufficiently distant from the site of
`stimulation, so to enable detection of nerve conduction despite the confounding interference from the
`direct electrical stimuli. In these embodiments, direct electrical stimulation of nerve and muscle may
`be tailored to provide optimal therapy and, in the case of electrode migration or other electrode
`malfunction, to report lack of stimulation of the bodily tissues. Furthermore, these embodiments
`enable a reduction in power requirement, because control of the signal is provided by the sensor to
`the signal generator loop.
`100371
`In other embodiments, an energy emitting system for providing a medical therapy is
`provided. The system may include one or more conductive coils disposed within or along a housing
`and configured to generate a magnetic field focused on a target nerve in proximity to coils; one or
`more sensors in the form of rnicroneedle patch configured to detect electrical conduction in the target
`
`7.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 31
`
`

`

`Attorney Docket Ne;:.-EMICNNZ00301
`
`nerve; and a controller coupled to the conductive coils and optionally in communication with the
`sensor.
`
`[00381
`In other embodiments, an energy emitting system for providing a medical therapy is
`provided. The system may include one or more microncedle patches having one or more
`5 microneedle arrays deposited on a surface of one or more electrodes and configured to generate or
`deliver an electrical or magnetic stimulus or field focused on a target nerve in proximity to the
`microncedle patch; one or more sensors configured to detect electrical conduction in the target nerve;
`and a controller coupled to the conductive coils and optionally in communication with the sensor.
`Optionally, the above embodiments may incorporate an electrode needle. Optionally, the above
`embodiments or systems may be utilized without a sensor or mechanism for detecting conduction or
`stimulation.
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`10
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`[00391
`Methods of use of the above apparatus, systems and variations thereof for treating
`various conditions are also described herein.
`
`[00401
`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
`
`[00411
`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.
`
`FIG. 1 is a schematic view of an apparatus for magnetic induction therapy according
`[00421
`to a first embodiment of the invention.
`FIG. 2 is a schematic view of an apparatus for magnetic induction therapy according
`100431
`to a second embodiment of the invention.
`FIG. 3 is a schematic view of an apparatus for magnetic induction therapy according
`[00441
`to a third embodiment of the invention.
`FIG. 4 is a schematic view of an apparatus for magnetic induction therapy according
`100451
`to a fourth embodiment of the invention.
`FIG. 5 is a schematic view of an apparatus for magnetic induction therapy according
`100461
`to a fifth embodiment of the invention.
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`8
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`Petitioner - Avation Medical, Inc.
`Ex. 1047, p. 32
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`

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`Attorney Docket No.: EMICNNZ00301
`
`100471
`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.
`[0048)
`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.
`[0049)
`FIG. 8 is a schematic view of an embodiment of the invention that includes a
`plurality of sensors.
`[00501
`FIGS. 9A-9D are schematic representations of different garments adapted to operate
`as apparatus for magnetic induction therapy according to the principles of the present invention.
`[00511
`FIGS. 10 is a schematic view of an apparatus for providing electrical stimulation.
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`5
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`[00521
`FIG. 11 is a schematic view of another embodiment of an apparatus for providing
`electrical stimulation.
`[00531
`FIG. 12 shows a schematic view of an energy emitting system including a
`15 microneedle patch sensor.
`[0054]
`FIG. 13-15 shows magnified bottom views of various embodiments of microneedle
`
`patches.
`
`[00551
`patch.
`
`FIGS. 16-17 shows magnified side views of various embodiments of a micronecdle
`
`20
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`[0056]
`
`FIG. 18 shows a magnified bottom perspective view of a microneedle patch.
`FIG. 19 shows a representative cross sectional view of the skin composed of an
`[0057]
`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.
`
`FIG. 20 shows a magnified side view of a variation of a microneedle patch including
`[0058]
`25 multiple electrodes.
`FIG. 21 shows a schematic view of an energy emitting system including a
`[0059]
`microneedle patch sensor placed behind a subject's knee.
`FIGS. 22-23 show schematic views of energy emitting system