35196-01020
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`METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY
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`CROSS-REFERENCE TO RELATED APPLICATIONS
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`[0001] The present application claims priority to U.S. Provisional Patent Application Serial No.
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`60/848,720, filed on October 2, 2006 and titled: "Method and Apparatus for Magnetic Induction
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`Therapy."
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`FIELD OF THE INVENTION
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`[0002] The present invention relates to energy emitting apparatus and methods for providing a
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`medical therapy. In one embodiment, the energy emitting apparatus is an ergonomic wrap or
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`cradle that contains conductive coils generating a magnetic field directed to a target nerve.
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`BACKGROUND OF THE INVENTION
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`[0003]
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`Overactive bladder ("OAB") and urinary incontinence ("UI") affect over 16% of the
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`American population each year, or approximately 34 million men and women. Outside of the
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`United States, OAB and UI affects over 46 million Europeans. The economic cost of OAB and
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`UI is estimated to be in excess of $12 billion a year in the United States alone.
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`[0004]
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`Due to the social stigmas attached to OAB and UI and to misunderstandings related to
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`the symptoms associated with OAB and UI, only 40% of the affected individuals in the United
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`States seek medical treatment. Of those 13.6 million Americans seeking medical treatment,
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`nearly 30% or 4 million individuals are reportedly unsatisfied with their current therapy.
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`[0005]
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`Known treatments for OAB and UI include exercise and behavioral modifications,
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`pharmacological therapies, surgical intervention and neuromodulation, but each of these
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`treatments exhibits severe limitations.
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`[0006]
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`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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`regimens. While this type of treatment may be a viable option for a small group of highly
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`dedicated individuals, its daily impact on a person's life makes it unattractive for most patients.
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`1
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`Petitioner - Avation Medical, Inc.
`Ex. 1048, p. 1
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`

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`[0007]
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`Pharmacological intervention is the most widely prescribed therapy for OAB and UI.
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`Unfortunately, patients often suffer from side effects related to their drug therapies. Such side
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`effects are sometimes serious and are particularly pronounced in elderly patient populations that
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`tend to use a plurality of medications. In addition, approximately 30% of all patients subjected to
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`pharmacological therapies appear to be dissatisfied with the efficacy of their prescribed
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`treatments.
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`[0008]
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`Surgical intervention is extremely invasive and often results in a long-term
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`requirement for catheterization that may become permanent in some instances. The negative
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`impact of these procedures on the patient's quality of life and their high expense make surgical
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`intervention a recommended option only when all other treatment options have been exhausted.
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`[0009]
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`Neuromodulation is another available therapy for OAB and UI. In general, pulsed
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`electromagnetic stimulation ("PES") has proven to have beneficial effects in a variety of medical
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`applications. The related scientific principle is that an electric current passing through a coil
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`generates an electromagnetic field, which induces a current within a conductive material placed
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`inside the electromagnetic field.
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`[0010] More particularly, PES has been shown to be an effective method of stimulating a
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`nerve positioned within the electromagnetic field, thereby affecting a muscle controlled by that
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`nerve. For example, in the paper titled "Contactless Nerve Stimulation and Signal Detection by
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`Inductive Transducer" presented at the 1969 Symposium on Application of Magnetism in
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`Bioengineering, Maass et al. disclosed that a nerve threading the lumen of a toroid could be
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`stimulated by a magnetic field of 0.7 Volt peak amplitude and a 50 µs duration in a monitor wire,
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`and that such stimulation could generate a contraction of major leg muscles in anesthetized
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`mammals.
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`[0011]
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`Various attempts were made in the prior art to use PES for treating a variety of
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`ailments. For example, U.S. Patent No. 4,548,208 to Niemi discloses an apparatus for inducing
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`bone growth by generating an electric current in the body through the external application of an
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`electromagnetic field. Such apparatus includes opposing clamps disposed on a limb and may
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`optionally include feedback coils and a microprocessor for sensing the magnetic field, so to
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`avoid an overcurrent mode. Therefore, this apparatus optimizes the magnetic field on the basis of
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`measurements of the generated magnetic field.
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`[0012]
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`U.S. Patent No. 4,940,453 to Cadwell discloses a method and apparatus for
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`2
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`Petitioner - Avation Medical, Inc.
`Ex. 1048, p. 2
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`

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`magnetically stimulating the neural pathways of a higher level organism. In this invention, a
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`sinusoidally fluctuating current flow is created through a coil that overlies neurons to be
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`stimulated, and frequency of the current flow and frequency of the magnetic field produced by
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`the coil predetermined to correspond to the time constant of the neurons to be stimulated.
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`Sensors for sensing coil conditions, such as coil temperature, may also be included.
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`[0013]
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`U.S. Patent No. 5,000,178 to Griffith discloses an electrical to electromagnetic
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`transducer for applying electromagnetic energy to damaged parts of a living body by directing
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`electromagnetic radiation to a certain damaged body part. Electromagnetic radiation is initially
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`generated by a dipole consisting of a bar of high permeability material wrapped with an
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`electrically conductive coil. Magnetic fields, which are generated away from the damaged body
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`part, intersect a conductive shield and establish eddy currents, which in turn generate magnetic
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`fields opposite and nearly equal to the magnetic fields generated by the electromagnetic source.
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`The resultant electromagnetic fields reinforce the electromagnetic field directed towards the
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`damaged body part and diminish the electromagnetic field directed away from the damaged body
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`part.
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`[0014]
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`U.S. Patent No. 5,014,699 to Pollack et al. discloses a non-invasive, portable
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`electromagnetic therapeutic method and apparatus for promoting the healing of damaged or
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`diseased living tissue, including fractured bone. These method and apparatus involve generating
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`a signal that has a series of substantially symmetric voltage cycles of bursted pulses with narrow
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`pulse widths of 0.5 to 20 microseconds, and further involve converting the signal into an
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`electromagnetic field extending into an area that contains tissue to be healed. This invention
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`provides for no feedback on the efficiency of the applied stimulation.
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`[0015]
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`In a paper titled "Selective Stimulation and Blocking of Sacral Nerves: Research
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`Setup and Preliminary Results," published in Annual International Conference of the IEEE
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`Engineering in Medicine and Biology Society, Vol. 13, No. 2, 1991, Wijkstrda et al. used an
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`external pulsed magnetic coil to stimulate a peripheral nerve for the treatment of urinary
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`incontinence. The authors used a large magnetic field produced by a single coil to ensure that the
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`nerve was fired and the resulting nerve conduction was frequently painful or intolerable. In
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`addition, coil alignment was problematic because an internally implanted coil was utilized,
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`which had to be aligned with the fully external magnetic field to stimulate the nerve. Due to the
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`difficulty in positioning the device, the practical application of this therapy does not permit home
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`3
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`Petitioner - Avation Medical, Inc.
`Ex. 1048, p. 3
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`

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`healthcare usage without a preset alignment and monitoring of the nerve, and no provision was
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`made to insure that the nerve was actually being stimulated or to adjust the device in response to
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`commonly occurring physiologic and anatomic variations in nerve locations.
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`[0016]
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`U.S. Patent Nos. 5,181,902 Erickson et al. and 5,314,401 to Tepper disclose pulsed
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`electromagnetic field ("PEMF") transducer systems usable to perform PEMF therapies (such as
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`after spinal fusion) by generating flux-aided electromagnetic fields. The drive electronics
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`includes a PEMF processor that executes a PEMF program for controlling the activation of the
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`electromagnetic fields (field strength and cycle).
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`[0017]
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`In a paper titled: "Magnetic Stimulation of the Bladder in Dogs" presented at the
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`1993 AAEM Annual Meeting, the abstract of which was published in the Muscle & Nerve issue
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`of October 1993, Lin et al. disclosed that magnetic stimulation could be employed to stimulate
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`the cortex, spinal nerves and peripheral nerves of dogs through direct trans-abdominal
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`stimulation of the detrusor muscles or through stimulation of the lumbosacral roots.
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`[0018]
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`As shown, the prior art makes no provision to measure the efficacy of PES treatment,
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`causing patients to be treated improperly, either by an insufficient or excessive exposure to PES.
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`Other attempts to monitor PES dosage in the prior art exhibit serious drawbacks. For example,
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`U.S. Patent No. 5,518,495 to Kot discloses an apparatus for the treatment of arthritis utilizing a
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`magnetic field therapy, which includes an adjustable voltage source that is connected to a source
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`of line voltage and a coil connected to the adjustable voltage source. This apparatus has no
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`feedback system to advise a healthcare provider of the efficiency of the treatment.
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`[0019]
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`U.S. Patent No. 5,984,854 to Ishikawa et al. discloses a method for treating urinary
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`incontinence based on delivering a train of current pulses through one or more magnetic
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`stimulation coils so to induce a train of magnetic flux pulses, which then induce an eddy current
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`within the body and stimulates a group of pelvic floor muscles, the pudendal nerve, the external
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`urethral sphincter, or the tibial nerve. While this method includes the use of pulsed
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`electromagnetic for treating urinary incontinence, no specific components are envisioned to
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`facilitate the placement of the magnetic coils over a targeted region of the body or a system for
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`monitoring the efficiency of the therapy being applied.
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`[0020]
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`U.S. Patent No. 6,086,525 to Davey et al. discloses a magnetic nerve stimulator that
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`includes a core constructed from a material having a high field saturation having a coil winding
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`disposed thereon. A thyrister capacitive discharge circuit pulses the device, and a rapidly
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`4
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`Petitioner - Avation Medical, Inc.
`Ex. 1048, p. 4
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`changing magnetic field is guided by the core, preferably made from vanadium permendur.
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`[0021]
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`U.S. Patent No. 6,701,185 to Burnett et al. also discloses an electromagnetic
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`stimulation device that includes a plurality of overlapping coils, which can be independently
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`energized in a predetermined sequence such that each coil will generate its own independent
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`electromagnetic field and significantly increase the adjacent field. Unfortunately, none of these
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`patents provides a system for monitoring the efficiency of the therapy in progress, either with
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`respect to the proper positioning of the winding over the area to be treated or of the intensity of
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`the magnetic field to be applied.
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`[0022]
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`Other PES therapies require the implantation of devices into the patient, with the
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`consequent discomfort, risk and cost to the patient. For example, U.S. Patent No. 6,735,474 to
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`Loeb et al. discloses a method and system for treating UI and/or pelvic pain by injecting or
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`laparoscopically implanting one or more battery- or radio frequency-powered microstimulators
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`that include electrodes placed beneath the skin of the perineum and/or adjacent the tibial nerve.
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`[0023]
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`U.S. Patent 6,941,171 to Mann et al. describes a method and a system for treating
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`incontinence, urgency, frequency, and/or pelvic pain that includes implantation of electrodes on
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`a lead or a discharge portion of a catheter adjacent the perineal nerve(s) or tissue(s) to be
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`stimulated. Stimulation pulses, either electrical or drug infusion pulses, are supplied by a
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`stimulator implanted remotely through the lead or catheter, which is tunneled subcutaneously
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`between the stimulator and stimulation site.
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`[0024]
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`Other PES therapies in the prior art involve the use of electrodes placed on or beneath
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`the skin of a patient. Recent data on invasive, needle-based PES of the posterior tibial nerve in
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`individuals with OAB and UI indicates that PES can modulate bladder dysfunction through its
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`action on the pudendal nerve and the sacral plexus, which provide the major excitatory input to
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`the bladder.
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`[0025]
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`In a paper titled "Percutaneous Tibial Nerve Stimulation via Urgent® PC
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`Neuromodulation System — An Emerging Technology for managing Overactive Bladder," which
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`was published in Business Briefing: Global Surgery 2004, CystoMedix, Inc. disclosed that
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`peripheral tibial nerve stimulation ("PTNS") had been found effective in treating OAB. The
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`disclosed procedure involved the use of electrode and generator components, including a small
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`34-gauge needle electrode, lead wires and a hand-held electrical generator. However, the
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`procedure requires the permanent implantation of an electrical stimulation device in the patient.
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`5
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`Petitioner - Avation Medical, Inc.
`Ex. 1048, p. 5
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`One estimate put the cost of treatment at nearly $14,000 with additional routine care costs of
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`$593 per patient per year. Additionally, risks of battery failure, implant infection, and electrode
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`migration led to a high re-operation rate and made this procedure unattractive.
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`[0026]
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`U.S. Patent No. 7,117,034 to Kronberg discloses a method for generating an electrical
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`signal for use in biomedical applications that includes two timing-interval generators. In this
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`invention, skin-contact electrodes may be placed over an area of interest and a microprocessor
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`may direct timing and sequencing functions, although such timing and sequencing functions are
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`not related to the actual efficacy of the treatment while treatment is being performed.
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`[0027]
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`U.S. Patent Application Publication No. 2005/0171576 to Williams et al. discloses an
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`electro-nerve stimulation apparatus that includes a pulse generator, a first electrically conductive,
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`insulated lead wire, a second electrically conductive, insulated lead wire, an electrically
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`conductive transcutaneous electrode and an electrically conductive percutaneous needle
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`electrode. Connected to one end of the first and second lead wires is a connector for electrically
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`coupling with the pulse generator. In this invention, a percutaneous needle electrode is inserted
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`through the skin in proximity to the desired internal stimulation site and electric stimulation is
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`employed, rather than pulsed electromagnetic stimulation. Moreover, the Williams invention
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`does not contemplate mechanisms for facilitating use of the device by an untrained user, nor a
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`monitoring of the applied therapy.
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`[0028]
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`A neuromodulation alternative is a posterior tibial nerve stimulator, often referred to
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`as SANS, but as is the case with other forms of neuromodulation, this procedure is invasive in
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`nature and requires the insertion of a needle five centimeters into the patient's ankle region to
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`stimulate the posterior tibial nerve. This procedure also requires a minimum of twelve sessions
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`for initial treatment, possibly with additional sessions required for maintenance.
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`SUMMARY OF THE INVENTION
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`[0029]
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`It is an object of the present invention to provide apparatus and methods for magnetic
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`induction therapy, in which dosage of magnetic energy can be regulated according conduction in
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`a target nerve exposed to the magnetic field.
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`[0030]
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`It is another object of the present invention to provide apparatus and methods for
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`magnetic induction therapy, in which the flow of magnetic energy can be adjusted directionally
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`by the patient or a healthcare provider without altering the position of a housing containing
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`6
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`Petitioner - Avation Medical, Inc.
`Ex. 1048, p. 6
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`

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`conductive coils that produce the magnetic field.
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`[0031]
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`It is a further object of the present invention to provide apparatus and methods for
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`treating a variety of ailments by providing energy to a target nerve, for example magnetic
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`energy, electrical energy or ultrasound energy, at a location and in an amount optimized by
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`detecting conduction in the target nerve.
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`[0032]
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`These and other objects of the present invention are achieved by providing an energy
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`emitting apparatus for delivering a medical therapy that includes one or more energy generators,
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`a logic controller electrically connected to the one or more energy generators, and one or more
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`sensors for detecting electric conduction in a target nerve, which are connected to the logic
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`controller. The one or more energy generators produce energy focused on the target nerve upon
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`receiving a signal from the logic controller, and the applied energy is varied by the logic
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`controller according to an input provided by the one or more sensors based on electric
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`conduction in the target nerve. The feedback provided by the sensors to the logic controller
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`about the efficacy of the applied treatment causes the logic controller to modulate the current
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`transmitted to the coils.
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`[0033]
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`The applied energy may be a magnetic field, an electrical field, an ultrasound, a
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`visible light, or an infrared or an ultraviolet energy. When a magnetic field is applied, the
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`energy-emitting device is an apparatus that provides a magnetic induction therapy and that
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`includes one or more conductive coils disposed in an ergonomic housing. A logic controller is
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`electrically connected to the one or more coils, and one or more sensors detect electric
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`conduction in the target nerve and are connected to the logic controller so to provide a feedback
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`to the logic controller. The conductive coils receive an electric current from the logic controller
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`and produce a magnetic field focused on a target nerve, and the electric current fed by the logic
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`controller is varied by the logic controller according to an input provided by the sensors, thereby
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`causing amplitude, frequency or direction of the magnetic field, or the firing sequence of the one
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`or more coils, to be varied according to the efficiency of the treatment provided to the target
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`nerve. In different embodiments of the invention, the housing containing the conductive coils
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`may be a flexible wrap, a cradle or a garment, and the coils may be overlapping and/or be
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`disposed in different positions within the housing, so to generate a magnetic field on different
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`body parts with the desired direction and amplitude.
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`[0034]
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`The one or more coils may be stationary or movable within the housing, making it
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`7
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`Petitioner - Avation Medical, Inc.
`Ex. 1048, p. 7
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`

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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 embodiments, the coils may be movable manually by
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`acting on a knob, lever, or similar type of actuator, or may be translated automatically by the
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`logic controller in response to the input provided by the sensors. When a preferred position for
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`the coils has been established, the coils may be locked in position and maintain that position
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`during successive therapy sessions. In other embodiments, the sensors may be incorporated
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`within the housing, or instead may be disposed on a body part of interest independently of the
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`housing.
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`[0035]
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`In still other embodiments of the invention, the inductive coils are disposed in a
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`housing that is situated externally to a patient's body, and additional inductive coils are
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`implanted into the body of the patient and are magnetically coupled to the external inductive
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`coils. With this coil arrangement, energy may be transmitted from the external coils to the
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`internal coils either to recharge or to activate an implantable device. In yet other embodiments
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`of the invention, the electric current may varied by the logic controller both on the basis of an
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`input provided by the one or more sensors and also an input provided by the patient according to
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`a muscular response she has perceived, for example, the twitching of a toe after application of
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`the magnetic field.
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`[0036]
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`In yet other embodiments of the invention, the source of energy for nerve stimulation
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`may be 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 the confounding
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`interference from the direct electrical stimuli. In these embodiments, direct electrical stimulation
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`of nerve and muscle may be tailored to provide optimal therapy and, in the case of electrode
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`migration or other electrode malfunction, to report lack of stimulation of the bodily tissues.
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`Furthermore, these embodiments enable a reduction in power requirement, because control of the
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`signal is provided by the sensor to the signal generator loop.
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`[0037] Methods of use of the above apparatus are also described herein.
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`BRIEF DESCRIPTION OF THE DRAWINGS
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`[0038]
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`The drawings constitute a part of this specification and include exemplary
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`embodiments of the invention, which may be embodied in various forms. It is to be understood
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`that in some instances various aspects of the invention may be shown exaggerated or enlarged to
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`8
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`Petitioner - Avation Medical, Inc.
`Ex. 1048, p. 8
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`

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`facilitate an understanding of the invention.
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`[0039]
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`FIG. 1 is a schematic view of an
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`apparatus for magnetic induction therapy according
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`to a first embodiment of the invention.
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`[0040]
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`FIG. 2 is a schematic view of an
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`apparatus for magnetic induction therapy according
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`to a second embodiment of the invention.
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`[0041]
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`FIG. 3 is a schematic view of an
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`apparatus for magnetic induction therapy according
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`to a third embodiment of the invention.
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`[0042]
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`FIG. 4 is a schematic view of an
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`apparatus for magnetic induction therapy according
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`to a fourth embodiment of the invention.
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`[0043]
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`FIG. 5 is a schematic view of an
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`apparatus for magnetic induction therapy according
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`to a fifth embodiment of the invention.
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`[0044]
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`FIGS. 6A-6D are schematic illustrations depicting a first method of use of an
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`apparatus for magnetic induction therapy. This method is based on adjusting the position of the
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`conductive coils so to optimize a magnetic flow applied to a target nerve.
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`[0045]
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`FIGS. 7A-7D are schematic illustrations of a second method of use of an apparatus
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`for magnetic induction therapy. This method is based on locking the conductive coils in position
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`once electrical conduction in a target nerve has been detected.
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`[0046]
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`FIG. 8 is a schematic view of an embodiment of the invention that includes a plurality
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`of sensors.
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`[0047]
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`FIGS. 9A-9D are schematic representations of different garments adapted to operate
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`as apparatus for magnetic induction therapy according to the principles of the present invention.
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`DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
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`[0048]
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`Detailed descriptions of embodiments of the invention are provided herein. It is to be
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`understood, however, that the present invention may be embodied in various forms. Therefore,
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`the specific details disclosed herein are not to be interpreted as limiting, but rather as a
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`representative basis for teaching one skilled in the art how to employ the present invention in
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`virtually any detailed system, structure, or manner.
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`[0049]
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`Referring first to FIG. 1, a first embodiment of the invention includes a coil wrap 20,
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`which is depicted as disposed over ankle 22 circumferentially to surround a portion of tibial
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`nerve 24. Because tibial nerve 24 is targeted, this embodiment is particularly suited for the
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`9
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`Petitioner - Avation Medical, Inc.
`Ex. 1048, p. 9
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`

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`treatment of OAB and UI.
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`In other embodiments of the invention, coil wrap 20 may be
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`configured to surround other body parts that contain a portion of tibial nerve 24 or of other
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`nerves branching from or connected to tibial nerve 24, still making these embodiments suitable
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`for treating OAB and UI. In still other embodiments of the invention, coil wrap 20 may be
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`configured for surrounding body parts that contain other nerves when treatments of other
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`ailments are intended.
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`[0050]
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`Coil wrap 20 may be manufactured from a variety of materials suitable for wearing
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`over ankle 22. Preferably, coil wrap is produced from a soft, body-compatible material, natural
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`or synthetic, for example, cotton, wool, polyester, rayon, Gore-Tex ®, or other fibers or materials
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`known to a person skilled in the art as non-irritating and preferably breathable when tailored into
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`a garment. Coil wrap 22 may even be manufactured from a molded or cast synthetic material,
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`such as a urethane gel, to add extra comfort to the patient by providing a soft and drapable feel.
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`Additionally, coil wrap 20 may be produced from a single layer of material or from multiple
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`material layers and may include padding or other filling between the layers.
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`[0051]
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`Coil wrap 20 contains one or more conductive coils 26 arranged to produce a pulsed
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`magnetic field that will flow across tibial nerve 24 and generate a current that will flow along
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`tibial nerve 24 and spread along the length of tibial nerve 24 all the way to its sacral or pudendal
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`nerve root origins. Coils 26 may be a single coil shaped in a simple helical pattern or as a figure
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`eight coil, a four leaf clover coil, a Helmholtz coil, a modified Helmholtz coil, or may be shaped
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`as a combination of the aforementioned coils patterns. Additionally, other coil designs beyond
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`those mentioned 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, such
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`coils may be disposed on a single side of ankle 22, or may be disposed on more than one side, for
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`example, on opposing sides, strengthening and directionalizing the flow of the magnetic field
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`through tibial nerve 24 or other peripheral nerves of interest.
`
`[0052]
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`Coil wrap 20 is preferably configured as an ergonomic wrap, for example, as an
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`essentially cylindrical band that can be pulled over ankle 22, or as an open band that can be
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`wrapped around ankle 22 and have its ends connected with a buckle, a hoop and loop system, or
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`any other closing system known to a person skilled in the art. By properly adjusting the position
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`of coil wrap 20 over ankle 22, a patient or a health care provider may optimize the flow of the
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`magnetic field through tibial nerve 24, based on system feedback or on sensory perceptions of
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`10
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`Petitioner - Avation Medical, Inc.
`Ex. 1048, p. 10
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`

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`the patient, as described in greater detail below.
`
`[0053]
`
`The electric current that produces the magnetic field by flowing through coils 26 is
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`supplied by a programmable logic controller 28, which is connected to coils 26, for example,
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`with a power cord 32. A sensor 30 that feeds information to logic controller 28 is also provided,
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`in order to tailor the strength of the magnetic field and control activation of coils 26 based on
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`nerve conduction. The purpose of sensor 30 is to detect and record the firing of the target nerve
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`and to provide related information to logic controller 28, so to render the intended therapy most
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`effective. For example, sensor input may cause logic controller 28 to alter the strength or pulse
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`amplitude of the magnetic field based on sensor input, or fire the coils in a certain sequence.
`
`[0054]
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`In this embodiment, as well as in the other embodiments described hereinafter, sensor
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`30 may include one or more sensor patches and may be placed at different distances from the
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`region of direct exposure to the magnetic field. For example, sensor 30 may be configured as a
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`voltage or current detector in the form of an EKG patch and may be placed anywhere in the
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`vicinity of the target nerve to detect its activation. For ease of description, the term "coils" will
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`be used hereinafter to indicate "one or more coils" and "sensor" to indicate "one or more
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`sensors," unless specified otherwise.
`
`[0055]
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`By virtue of the above described arrangement, coil wrap 20 provides a reproducibly
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`correct level of stimulation during an initial therapy session and during successive therapy
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`sessions, because the presence or absence of nerve conduction is detected and, in some
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`embodiments, measured when coil wrap 20 is first fitted and fine-tuned on the patient.
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`In
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`addition to properly modulating the applied magnetic field, the positioning of coils 26 over ankle
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`22 may also be tailored according to the input provided by sensor 30, so to fine-tune the direction
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`of the magnetic field. Such an adjustment of the direction, amplitude, and level of the
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`stimulation provided to the target nerve through the above described automated feedback loop, to
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`ensure that peripheral nerve conduction is being achieved, is one of the key features in the
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`present invention.
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`[0056]
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`If the magnetic pulse does not substantially interfere with sensor 30, sensor 30 may
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`be placed directly within the field of stimulation, so that power supplied to the system may be
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`conserved. This is particularly important for battery-powered systems. Alternatively, sensor 30
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`may also be placed at a distance from the magnetic field and still properly detect neural
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`stimulation.
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`11
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`Petitioner - Avation Medical, Inc.
`Ex. 1048, p. 11
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`

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`[0057]
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`In a method of use of coil wrap 20, the amplitude and/or firing sequence of coils 26
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`may be ramped up progressively, so that the magnetic field is increased in strength and/or
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`breadth until nerve conduction is detected, after which the applied stimulus is adjusted or
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`maintained at its current level for the remainder of the therapy. The level of stimulation may be
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`also controlled through a combination of feedback from sensor 30 and feedback based on
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`perceptions of the patient. For example, the patient may activate a switch once she perceives an
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`excessive stimulation, in particular, an excessive level of muscular stimulation. In one instance,
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`the patient may be asked to push a button or turn a knob when she feels her toe twitching or
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`when she experiences paresthesia over the sole of her foot. The patient will then continue
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`pressing the button or keep the knob in the rotated position until she can no longer feel her toe
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`twitching or paresthesia in her foot, indicating that that level of applied stimulation corresponds
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`to an optimal therapy level. From that point on, the patient may be instructed to simply retain
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`her foot, knee, or other limb within coil wrap 20 until therapy has been terminated while the
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`system is kept at the optimal level. Adding patient input enables control of coil wrap 20 during
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`outpatient treatments, because the patient is now able to adjust the intensity of the magnetic field
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`herself beyond the signals provided to logic controller 28 by sensor 30.
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`[0058]
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`Detecting and, if the case, measuring conduction in one or more nerves along the
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`conduction pathways of the stimulated nerve confirms that the target nerve has been stimulated,
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`providing an accurate assessment of the efficiency of the applied therapy on the patient. A
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`concomitant detection of muscle contraction may also confirm that the target nerve is being
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`stimulated and provide an indication to the patient or to a healthcare provider as to whether
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`stimulation has been applied at an excessive level in view of the anatomical and physiological
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`characteristics of the patient.
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`[0059]
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`Based on the foregoing, coil wrap 20 allows for a consistent, user-friendly targeting
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`and modulation of the peripheral nerves via the posterior tibial nerve on an outpatient basis, in
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`particular, the targeting and modulation of the pudendal nerve and of the sacral plexus. When
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`multiple coils 26 are present, coils 26 may be activated simultaneously or differentially to
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`generate the desired magnetic field. The direction and location of each of coils 26 may be
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`reversibly or irreversibly adjusted by the healthcare provider or by the patient, customizing the
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`location of the applied stimulation to the anatomy and therapy needs of each patient. After a
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`healthcare provider has optimized position and firing sequence for each of coils 26, th