PTO/SB/16 (10-01)
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`PROVISIONAL APPLICATION FOR PATENT COVER SHEET
`This is a request for filing a PROVISIONAL APPLICATION FOR PATENT under 37 CFR 1.53(c).
`I Express Mail Label No.
`
`Given Name (first and middle [if any])
`
`Family Name or Surname
`
`INVENTOR(S)
`
`CD
`
`. C\I
`co
`c0 -o
` •40'
`c.
`
`C.
`
`co
`Residence
`
`F2 C.0
`(City and either State or Foreign Country) ; •P•
`
`Daniel Rogers
`
`Burnett
`
`San Francisco, CA 94127
`
`q Additional inventors are being named on the
`
`separately numbered sheets attached hereto
`
`TITLE OF THE INVENTION (500 characters max)
`
`METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY AND NOTEBOOK PAGES
`
`Direct all correspondence to:
`
`n Customer Number
`
`OR
`
`Firm or
`Individual Name
`
`CORRESPONDENCE ADDRESS
`
`Type Customer Number here
`
`Therallova, LLC
`215 Valdez Avenue
`
`Address
`Address
`City
`Country
`
`San Francisco
`CA
`State
`USA
`(415) 585-8508
`Telephone
`ENCLOSED APPLICATION PARTS (check all that apply)
`El Specification Number of Pages
`58
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`ZIP 94127
`(415) 520-5455
`Fax
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`Ti Application Data Sheet. See 37 CFR 1.76
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`Applicant claims small entity status. See 37 CFR 1.27.
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`Respectfully submitted,
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`Date 9 / 30 / 06
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`SIGNATURE
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`TELEPHONE
`USE ONLY FOR FILING A PROVISIONAL APPLICATION FOR PATENT
`This collection of information is required by 37 CFR 1.51. The information is used by the public to file (and by the PTO to process) a
`provisional application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 8 hours to
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`20231. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Box Provisional Application, Assistant
`Commissioner for Patents, Washington, D.C. 20231.
`
`REGISTRATION NO.
`(if appropriate)
`Docket Number
`
`Petitioner - Avation Medical, Inc.
`Ex. 1049, p. 1
`
`

`

`PATENT APPLICATION
`
`METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY
`
`Inventors:
`
`DANIEL R. BURNETT, a citizen of the United States
`Residing at 215 Valdez Avenue
`San Francisco, California 94127
`
`SHANE MANGRUM, a citizen of the United States
`Residing at 5615 Canyonwood Circle
`Idaho Falls, Idaho 83406
`
`CHRISTOPHER HERMANSON, a citizen of the United States
`Residing at 49 Westdale Drive
`Santa Cruz, California 95060
`
`Assignee:
`
`THERANOVA, LLC
`215 Valdez Avenue
`San Francisco, California 94127
`
`Status:
`
`SMall Entity
`
`THERANOVA, LLC
`215 Valdez Avenue
`San Francisco, CA 94127
`Tel: 415-585-8508
`Email: uspto@theranova.net
`
`Petitioner - Avation Medical, Inc.
`Ex. 1049, p. 2
`
`

`

`PATENT
`
`METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY
`
`[0001] This application claims priority to U.S. Provisional Patent Application Serial No.
`
`60/643,145, filed January 12th, 2005 and is a continuation-in-part of U.S. Pat. No. 6,701,185
`
`entitled "Method and apparatus for electromagnetic stimulation of nerve, muscle, and body
`
`tissues" filed February 19th, 2002.
`
`BACKGROUND OF THE INVENTION
`
`[0002] The present invention relates to the field of medical devices, in particular therapeutic
`intervention devices for central and peripheral nerve modulation therapies, including both
`excitation and blocking of nerve impulses. Of particular interest is the treatment and prevention
`of urinary incontinence (UI) and overactive bladder (OAB) with the use of Low Frequency
`Induction Therapy (LoFIT).
`
`[0003] The OAB and UI market in the United States is well over a $12 billion a year industry.
`It affects over 16% of all Americans, for a total U.S. market of approximately 34 million men
`and women each year. Due to social stigmas attached to OAB and UI, as well as
`misunderstanding of the signs and symptoms associated with OAB and UI, only 40% of those
`affected (13.6M) seek treatment. Of those 13.6 million individuals, nearly 30% are unsatisfied
`with their current therapy.
`
`[0004] The use of pulsed electromagnetic stimulation (PES) has been well established as a
`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 field.
`These fields, in turn, have been shown to induce current within conductive materials placed
`within the field. When applied to the human body, pulsed electromagnetic stimulation has been
`found to be an effective method of stimulating nerves resting within the electromagnetic field.
`Building on recent data, which highlights the beneficial effects of invasive, needle-based
`electrostimulation (ES) of the posterior tibial nerve in individuals with OAB and UI, there is
`
`Petitioner - Avation Medical, Inc.
`Ex. 1049, p. 3
`
`

`

`strong evidence for the treatment of these ailments with the use of LoFIT. In particular, ES has
`
`been found to modulate bladder dysfunction through its action on the pudendal nerve and the
`
`sacral plexus which provides the major excitatory input to the bladder.
`
`[0005] Current treatment options for OAB and UI are exercise and behavioral modifications,
`
`pharmacological therapies, surgical intervention, and neuromodulation. Although each of these
`
`treatment options targets the UI and OAB populations, each has severe limitations.
`
`[0006] Exercise and behavioral modifications often require patients to adhere to stringent
`
`routines, including scheduled voiding, maintenance of a bladder diary, and intense exercise
`
`regiments. While this may be a viable option for a small group of highly dedicated individuals,
`its daily impact on one's life makes it an unattractive option for most individuals.
`
`[0007] Pharmacological intervention is the most widely prescribed therapy for OAB and UI.
`Unfortunately, as with the ingestion of any chemical, patients are often subject to side effects
`from their drug therapy. This is especially detrimental in older and elderly patient populations
`where interaction with other prescribed medications can have adverse effects. Further, there is a
`high rate of dissatisfaction, approximately 30%, amongst individuals using pharmacological
`treatment.
`
`[0008] Surgical intervention is an extremely invasive treatment and often results in the long-
`term, and in some cases permanent, requirement for catheterization. The high expense of these
`procedures, coupled with the negative impact the procedures have on the patients quality of life,
`make this an option only when all other treatment options have been exhausted.
`
`[0009] Neuromodulation is another treatment alternative for OAB and UI patients. Sacral
`nerve stimulation (SNS) has shown itself to be an effective treatment option for those with OAB
`or UI. However, the procedure requires the permanent implantation of an electrical stimulation
`device in the patient. One estimate puts the cost at nearly $14,000 with additional routine care
`costs of $593 per patient per year. Additionally, SNS's risk of battery failure, implant infection,
`and electrode migration, lead to a high reoperation rate and make this procedure unattractive.
`
`[0010] More recently, the introduction of a posterior tibial nerve stimulator, often referred to as
`SANS, has shown itself to be another neuromodulation alternative. Yet as is the case with other
`forms of neuromodulation, this system is invasive in its nature. It requires the insertion of a
`needle two inches into the patient's ankle region in order to stimulate the posterior tibial nerve.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1049, p. 4
`
`

`

`As well, it requires a minimum of 12 sessions for initial treatment, with the possibility of
`additional sessions needed for maintenance. Despite its high cost and invasive nature, though, an
`
`abundance of published peer-reviewed clinical trials demonstrate the safety and efficacy of the
`
`SANS therapy.
`
`REVIEW OF THE PRIOR ART
`
`[0011] U.S. patent number 6,941,171 describes a method and system for treatment of
`
`incontinence, urgency, frequency, and/or pelvic pain includes implantation of electrodes on a
`
`lead or the discharge portion of a catheter adjacent the perineal nerve(s) or tissue(s) to be
`
`stimulated. Stimulation pulses, either electrical or drug infusion pulses, are supplied by a
`stimulator
`implanted remotely, and through
`
`lead or catheter, which is tunneled
`subcutaneously between the stimulator and stimulation site. This device, while holding some
`therapeutic potential, is invasive in its delivery and requirement for implantation of device
`components.
`
`the
`
`[0012] U.S. patent number 5,984,854 describes a method for treating urinary incontinence
`which consists of delivering a train of current pulses through one or more magnetic stimulation
`coils to induce a train of magnetic flux pulses, which then induce an eddy current within the
`body, thereby to stimulate a group of pelvic floor muscles, the pudendal nerve, the external
`urethral sphincter, or the tibial nerve. While this device describes the employment of pulsed
`electromagnetic fields in the treatment of urinary incontinence, the application does not
`contemplate the use of any specific component to facilitate the placement of the magnetic coils
`over a targeted region of the body. That is, the application describes holding a coil over an
`intended region of the body, but does not contemplate the use of ergonomic wraps or other
`means for allowing an untrained user to apply the intended treatments. The application also does
`not call for the monitoring of the therapy using sensors to ensure that the nerve is actually being
`stimulated and does not provide for adjustability of the device by the healthcare provider or user
`in order to accommodate for commonly occurring physiologic and anatomic variations in nerve
`locations.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1049, p. 5
`
`

`

`[0013] U.S. patent number 6,735,474 describes a method and system for treatment of
`
`incontinence and/or pelvic pain includes the injection or laparoscopic implantation of one or
`
`more battery- or radio frequency-powered microstimulators beneath the skin of the perineum
`
`and/or adjacent the tibial nerve. The devices are programmed using radio-frequency control via
`
`an external controller that can be used by a physician to produce patterns of output stimulation
`pulses judged to be efficacious by appropriate clinical testing to diminish symptoms. The
`stimulation program is retained in the microstimulator device or external controller and is
`transmitted when commanded to start and stop by a signal from the patient or caregiver. Again,
`this application involves the implantation of device components and is thus relatively invasive in
`nature. This patent also does not call for the monitoring of the therapy using sensors to ensure
`that the nerve is actually being stimulated and does not provide for adjustability of the device by
`the healthcare provider or user in order to accommodate for commonly occurring physiologic
`and anatomic variations in nerve locations.
`
`[0014] U.S. patent application 20050171576 describes an electro-nerve stimulation apparatus
`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. The
`transcutaneous electrode is operably connected to the other end of the first lead wire. An
`electrically conductive adaptor is secured to the other end of the second lead wire for electrically
`coupling to the terminal end of the percutaneous needle electrode. The lead wire set includes a
`single-use mechanism adapted to effectively discourage reuse of the electrodes. In use, the
`transcutaneous electrode is adhered to the patient's skin distal from the desired internal
`stimulation site. The percutaneous needle electrode is inserted through the skin in proximity to
`the desired internal stimulation site. The pulse generator is activated to pass current pulses
`between the transcutaneous electrode and the percutaneous needle electrode through the internal
`stimulation site. This device employs pulsed electric stimulation, and does not provide for the
`delivery of pulsed electromagnetic stimulation. Moreover, the device does not contemplate
`mechanism for facilitating use of the device by an untrained user (such as a wrap with markings
`to facilitate correct placement of the appliance). This application also • does not call for the
`monitoring of the therapy using sensors to ensure that the nerve is actually being stimulated and
`
`Petitioner - Avation Medical, Inc.
`Ex. 1049, p. 6
`
`

`

`does not provide for adjustability of the device by the healthcare provider or user in order to
`
`accommodate for commonly occurring physiologic and anatomic variations in nerve locations.
`
`[0015]
`
`In a paper by Wijkstrda, et al, entitled "Selective Stimulation And Blocking Of Sacral
`
`Nerves: Research Setup And Preliminary Results", published in Annual International Conference
`
`of the IEEE Engineering in Medicine and Biology Society, Vol 13, No 2, 1991, the authors used
`
`an external pulsed magnetic coil in order to stimulate a peripheral nerve for the treatment of
`
`urinary incontinence. In this paper, though, the authors used a large magnetic field in order to
`ensure that the nerve was fired and the resulting nerve conduction was frequently painful or
`intolerable. Also, the device had major issues with coil alignment in that it utilized an internally
`implanted coil which had to be aligned with the fully external magnetic field in order to stimulate
`the nerve. Due to the difficulty in positioning the device, as in the previous applications, the
`practical application of this therapy would not allow for home healthcare usage without preset
`alignment and monitoring of the nerve. As with the remainder of the prior art, though, this
`application does not call for the monitoring of the therapy using sensors to ensure that the nerve
`is actually being stimulated and does not provide for adjustability of the device by the healthcare
`provider or user in order to accommodate for commonly occurring physiologic and anatomic
`variations in nerve locations. This application also does not provide for the use of multiple coils,
`overlapping or non-overlapping, which may be stimulated simultaneously or in unison in order to
`focus or locally strengthen the field in order to more accurately target the nerve.
`
`[0016] Lastly, both U.S. patent numbers 6,086,525 and 5,984,854 both utilize pulsed magnetic
`fields in order to provide neuron-modulation for the treatment of urinary incontinence. While
`each of these applications have anticipated the use of external pulsed magnetic fields to stimulate
`the pudendal or sacral nerve offshoots, both are significantly preceded by the Wijkstrda paper
`mentioned above which was not considered as prior art in their issuance based on the prosecution
`history. Thus, broad claims such as the found in claim 1 of US Pat No 6,086,525 which are
`preceded by Wijkstrda are likely to be considered invalid. Regardless of the validity of these
`patents, though, neither document calls for the monitoring of the therapy using sensors to ensure
`that the nerve is actually being stimulated and neither provides for the use of a feedback loop
`with said sensors to ensure that the optimal level of stimulation is being generated despite
`varying conditions of the targeted region (ie ankle swelling will affect the required power to
`stimulate the nerve). Furthermore, neither application provides for adjustability of the device by
`
`Petitioner - Avation Medical, Inc.
`Ex. 1049, p. 7
`
`

`

`the healthcare provider or user (including the reversibly and irreversibly locking embodiments)
`in order to accommodate for customized nerve targeting required based on the commonly
`
`occurring physiologic and anatomic variations in nerve locations. These patents also do not
`
`provide for the use of multiple coils, overlapping or non-overlapping, which may be stimulated
`
`simultaneously or in unison in order to focus or locally strengthen the field in order to more
`
`accurately target the nerve.
`
`SUMMARY OF THE INVENTION
`
`[0017] The use of pulsed electromagnetic stimulation (PES) has been well established as a
`
`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 field.
`These fields, in turn, have been shown to induce current within conductive materials placed
`within the field. When applied to the human body, pulsed electromagnetic stimulation has been
`found to be an effective method of stimulating nerves resting within the electromagnetic field.
`
`[0018] Building on recent data, which highlights the beneficial effects of invasive, needle-
`based electrostimulation (ES) of the posterior tibial nerve in individuals with OAB and UI, there
`is strong evidence for the treatment of these ailments with the use of the proposed Low
`Frequency Induction Therapy System (LoFITTM System). In particular, ES has been found to
`modulate bladder dysfunction through its action on the pudendal nerve and the sacral plexus
`which provides the major excitatory input to the bladder. ES, and now the LoFIT System, have
`been built upon animal and human studies demonstrating how electrical stimulation of the pelvic
`and sacral nerves influence bladder emptying and provide neuromodulation therapies for OAB
`and UI. While the LoFITTM System is capable of generating an electrical stimulus identical to
`that found in ES, it is completely non-invasive and can be applied by an untrained user.
`
`[0019] The LoFITTM System, consists of two, or more, components: a programmable Logic
`Controller (LC), which generates the required current, and an ergonomic or body-contoured
`cradle or wrap containing inductive coils (CW), through which the current is channeled in
`generating the pulsed electromagnetic fields. The device may also optionally utilize a sensor
`patch, or other sensing device (SD), which may feed information back to the LC in order to tailor
`
`Petitioner - Avation Medical, Inc.
`Ex. 1049, p. 8
`
`

`

`the strength and of the magnetic field and control coil activation based on nerve conduction. The
`CW allows for consistent, user-friendly targeting and modulation of peripheral nerves, in
`particular the pudendal nerve and the sacral plexus, via the posterior tibial nerve, on an
`outpatient basis. The CW, preferably, may contain multiple coils which may be activated or
`triggered simultaneously or in unison in order to generate the desired field and the direction and
`location of each of these coils may be reversibly or irreversibly adjusted by the healthcare
`
`provider or user in order to customize the location of stimulation to each user. The patient may
`
`then be sent home with their adjusted coil which has been customized to consistently target the
`
`target nerve required for neuromodulation. Lastly, the use of the SD to automatically control the
`
`activation of the coil, or coils, has not been described in the literature. By using the SD to
`
`automatically feed information concerning nerve conduction back to the LC, the amplitude of the
`
`current sent to the CW, and the coils to which it is sent, may be tailored based on the information
`
`received from the SD indicating whether or not the nerve had fired. This allows for an
`
`unparalleled level of control and accuracy in this form of therapy with regards to consistent,
`
`repeatable stimulation of the nerve in the home healthcare setting. Aside from the obvious
`benefit of being able to focus the targeting coils to the patient's nerve in order to accommodate
`for physiologic variation, the ability to control the pulse amplitude is also of great importance.
`Take, for example, the patient with leg edema. In this patient, based on whether their legs and
`
`ankles are swollen or not swollen, the power required to penetrate to the poseterior tibial nerve,
`in the case of the urinary incontinence application, varies greatly due to the variable depth of the
`nerve.. Thus, having the SD feedback in this instance is not a luxury, but a necessity. The same
`is true of small alignment changes and other changes that may be found upon deployment in the
`variable home healthcare setting.
`
`[0020] The LoFITTM System is currently protected by 3 patents pending and one issued patent:
`U.S. Pat. No. 6,701,185 entitled "Method and apparatus for electromagnetic stimulation of nerve,
`muscle, and body tissues". Through benchtop testing, it has demonstrated that the LoFITTM
`System is capable of non-invasively generating electrical currents similar to those found in
`therapeutic ES.
`
`[0021]
`
`In its preferred embodiment, the CW is disposed in a flexible material. Said flexible
`material will be easily placed onto the body of the user for application of the LoFIT. Markings
`on this component may indicate how the wrap should be positioned on the body, making the
`
`Petitioner - Avation Medical, Inc.
`Ex. 1049, p. 9
`
`

`

`device easy to use and user-friendly. The device may be used while ambulatory or in a seated
`
`position. In another embodiment, the CW is disposed in a footrest or cradle and the user simply
`
`places their foot or leg into the rest (and adjacent to the coil) prior to therapy.
`
`In other
`
`embodiments, the CW may be disposed into back supports, girdles, arm slings, arm cradles, wrist
`
`cradles, wrist slings, neck bands, neck rests, headbands or headrests depending on the peripheral
`
`nerve to be targeted.
`
`[0022]
`
`In one embodiment of the device, the CW will contain an array of overlapping coils.
`
`The overlapping coils will help to assure accurate targeting of the posterior tibial nerve with the
`therapy in a home healthcare setting. In an alternative embodiment of the device, the CW will
`contain a Helmholtz coil arrangement disposed in the flexible material for the delivery of LoFIT.
`The coil arrangement may take any shape, though, so long as the stimulation of the nerve is
`achieved.
`
`[0023]
`
`In one embodiment of the device, said CW will be disposed in a material that is
`intended to be positioned over the ankle. This design will help to stimulate the posterior tibial
`nerve in the region of the ankle in a location that is easily targeted for therapeutic intervention.
`This material may be an ergonomic wrap and/or a fixed footrest into which the user may rest
`their leg and/or ankle and may target the posterior tibial nerve (or other peripheral nerve)
`anywhere along its length all the way to its sacral or pudendal nerve root origins.
`
`[0024]
`In this, and other,' embodiments, one or more patches or sensors may be placed at a site
`distant from the region of direct exposure to the magnetic coil impulse. This sensor or patch may
`be capable of detecting and recording the firing of nerves within the body. In particular, it may
`be able to accurately record the firing of the target nerve. This patch or sensor may also be used
`to tailor the firing of the coil (or coils) with increasing pulse amplitude until nerve conduction is
`detected. This system, then, is capable. of reproducibly ensuring that the correct level of
`stimulation is provided with every session due to the presence or absence of the nerve
`conduction impulse. The sequence of coil firing, or even pattern of coil firing, can also be
`tailored to optimize therapy based on sensor input control over power consumption and coil
`positioning. This automated feedback loop to adjust stimulation of one or more coils within the
`conductive wrap and/or foot/leg rest to ensure that peripheral nerve conduction is being achieved
`has not been described in the previous art and is one of the major innovations in the present
`invention. Ideally, the sensor will be a simple voltage or current detector, ie an EKG patch,
`
`Petitioner - Avation Medical, Inc.
`Ex. 1049, p. 10
`
`

`

`which can be placed anywhere in the vicinity of the nerve to detect its activation. In the ideal
`
`embodiment, as well, the amplitude and/or firing sequence of the coil or coils may be ramped to
`
`generate more powerful and/or broader magnetic fields until nerve conduction is detected. Once
`
`motor nerve conduction is detected, the stimulus may be adjusted or maintained at its current
`
`level for the duration of the therapy.
`
`In the instance where the sensor does not receive
`interference from the magnetic pulse, as well, the sensor may be placed directly in the field of
`stimulation.
`
`[0025] Additionally, the patient may provide feedback to control the level of stimulation. In
`this embodiment, the patient will activate a switch once a certain stimulus occurs, ie they feel
`their two twitch or they feel paresthesias over the sole of their foot. The device, then, may be
`controlled on an outpatient basis not only be the sensors attached to the controller, but also by
`patient input. In one example of this embodiment, the patient will be asked to activate a button
`once their toe begins to twitch. The patient will then be asked to continue pressing the button
`until they can no longer feel their toe twitching and, instead, feel a tingling (or paresthesia) in
`their foot. This indicates that the optimal therapy may be delivered at this stimulus level and the
`patient may be instructed to simply retain their foot, knee, etc. within the device until therapy has
`ended.
`
`[0026]
`
`In any of the embodiments mentioned, including the preferred embodiment, the coils
`may be adjustable within the wrap or device itself. In this preferred embodiment, the coils may
`be reversibly adjusted and, preferably, locked into place by the physician or healthcare provider
`prior to initiation of therapy. Once this optimization of the coil configuration has been achieved,
`the user may then continue their therapy in the home healthcare setting or within the physician or
`healthcare provider's office using their custom-targeted device with its locked coil configuration.
`
`[0027]
`In an alternative embodiment of the device, said CW will be disposed in a material that
`is intended to fit over the knee (or elsewhere along the course of the sacaral or pudendal nerve
`offshoots) for the delivery of therapeutic stimulation.
`
`[0028]
`In one embodiment of the device, the LC component is powered by a portable power
`source (e.g. rechargeable battery) to facilitate mobility with delivery of the intended treatment.
`In an alternative embodiment of the device, the LC can be powered by a fixed power source (e.g.
`plugging the device into a traditional outlet in the wall).
`
`Petitioner - Avation Medical, Inc.
`Ex. 1049, p. 11
`
`

`

`[0029] Despite the name LOFIT, it is important to note that any frequency of stimulation may
`
`be delivered by the present invention including, but not limited to, low-frequency, high-
`
`frequency, mid-frequency, ultrahigh frequency, etc. Furthermore, non-overlapping coils may
`also be used to generate the desired field, although overlapping or Helmholtz coils are ideal in
`their ability to target a broader region and achieve more thorough stimulation.
`
`[0030] Furthermore, while this summary has focused on the device and methods for
`stimulating the posterior tibial nerve and peripheral nerves related to the sacral and pudendal
`nerves for incontinence therapy, it may also be used for other peripheral and central nerve
`stimulation, so long as the stimulating coil or coils are at least in part controlled by automated
`feedback from the nerve conduction sensor and/or patient feedback described above. Thus, the
`coil or coils may be reversibly locked into an optimally targeted configuration within their
`ergonomic, body-contoured, wrap or cradle.
`
`[0031] Potential indications for which this therapy has been validated or may hold promise are
`broad including obesity, depression, urinary incontinence, fecal incontinence, hypertension, pain,
`back pain, restless leg syndrome, Guillain Barre syndrome, quadriplegia, paraplegia, diabetic
`polyneuropthy, dyskinesias, paresthesias, Dental procedure pain, Knee osteoarthritis, Anesthesia
`(pain relief during surgery), Alzheimer's disease, Angina (chest pain from heart disease),
`Ankylosing spondylitis, Back pain, Burn pain, Cancer pain, Chronic pain, Dysmenorrhea
`(painful menstruation), Headache, Hemiplegia, hemiparesis (paralysis on one side of the body),
`Labor pain, Local anesthesia during gallstone lithotripsy, Facial pain, trigeminal neuralgia,
`bruxism (tooth grinding) pain, Myofascial pain, Pregnancy-related nausea or vomiting, Neck and
`shoulder pain, Pain from broken bones, rib fracture or acute trauma, Diabetic peripheral
`neuropathy, Phantom limb pain, Post-herpetic neuralgia (pain after shingles), Postoperative ileus
`(bowel obstruction), Irritable Bowel Syndrome, Postoperative nausea or vomiting, Postoperative
`pain, Post-stroke rehabilitation, Rheumatoid arthritis, Skin ulcers, Spinal cord
`injury,
`Temporomandibular joint pain, Urinary incontinence, overactive bladder, detrusor instability,
`Spinal muscular atrophy (in children), Pain during hysteroscopy, Gastroparesis, Chronic
`obstructive pulmonary disease rehabilitation, Carpal tunnel syndrome, Soft tissue injury,
`Multiple sclerosis, Intermittent claudication, Attention-deficit hyperactivity disorder (ADHD),
`Cognitive impairment, Knee replacement pain, Achalasia, Atopic eczema, Bursitis, Carpal tunnel
`syndrome, Dementia, Depression, Dry mouth, Dystonia, Enhanced blood flow in the brain,
`
`Petitioner - Avation Medical, Inc.
`Ex. 1049, p. 12
`
`

`

`Enhanced blood perfusion of the uterus and placenta, Esophageal spasm, Fibromyalgia, Fracture
`
`pain, Guillain-Barre syndrome, Hemophilia, Herpes, Hip pain, Interstitial cystitis, Irritable bowel
`
`syndrome, Pruritis, Joint pain, Labor induction, Local anesthesia, Menstrual cramps, Muscle
`
`cramps, Muscle spasticity, Muscle strain or pain, Musculoskeletal trauma, Myofascial pain
`
`dysfunction syndrome, Nerve damage, Osteoarthritis, Pain medication adjunct, Pancreatitis,
`Raynaud's phenomenon, Repetitive strain injuries, Sacral pain, Schizophrenia, Shingles,
`Shoulder subluxation, Sickle cell anemia pain, Skin flap ischemia (during plastic surgery),
`Sphincter of Oddi disorders, Sports injuries, Thrombophlebitis, Tinnitus (ringing in the ear),
`Restless Legs, Tremor, Whiplash and Neuralgias. Once the target nerve has been identified, ie
`the vagal nerve for hypertension, the patient need simply apply the device with the
`ergonomically targeted coils and nerve conduction sensor to allow for repeatable, consistent
`neuromodulation based on sensor feedback to ensure proper nerve conduction has been achieved
`for the duration of the therapy. In contrast to implantable nerve stimulators, this therapy is
`completely non-invasive and does not require a major surgery to implant a permanent nerve
`stimulation device. In contrast to existing peripheral nerve stimulation technology (magnetic and
`electrical), as well, this therapy need not be delivered by a professional healthcare provider and
`can be controlled to optimize the level of therapy delivered based on power consumpti