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`
`METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY AND NOTEBOOK PAGES
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`LUMENIS EX1023
`Page 1
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`

`

`PATENT APPLICATION
`
`METHOD AND APPARATUS FOR MAGNETIC INDUCTION THERAPY
`
`Inventors:
`
`DANIEL R. BURNETT, a citizen of the United States
`Residing at 215 Valdez A venue
`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
`Re~iding at 49 Westdale Drive
`Santa Cruz, California 95060
`
`Assignee:
`
`THERANOV A, LLC
`·215 Valdez Avenue
`San Francisco, California 94127
`
`Status:
`
`Small Entity
`
`THERANOV A, LLC
`215 Valdez A venue
`San Francisco, CA 94127
`Tel: 415-585-8508
`Email: uspto@theranova.net
`
`LUMENIS EX1023
`Page 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-p_art 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 an~ 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 varfety 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
`
`LUMENIS EX1023
`Page 3
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`

`

`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 pudenda! 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 UL
`
`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(cid:173)
`
`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 UL However, the procedure requires the permanent implantation of an electrical stimuiation
`
`device in the patient. One estimate puts the cost at nearly $14,000 with add_itional 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.
`
`LUMENIS EX1023
`Page 4
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`

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`As wen; 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 perinea! 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
`
`the
`
`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.
`
`[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 pudenda! 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.
`
`LUMENIS EX1023
`Page 5
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`

`

`[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 e:xternal 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
`
`LUMENIS EX1023
`Page 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, ~ue 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 adj_ustability 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 pudenda! 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 reguired power to
`
`stimulate the nerve). Furthermore, neither application provides for adjustability of the device by
`
`LUMENIS EX1023
`Page 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(cid:173)
`
`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 pudenda! 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 LoFIT™ 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
`
`LUMENIS EX1023
`Page 8
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`

`

`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 o(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 or'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 LoFIT™ 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 LoFIT™
`
`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
`
`LUMENIS EX1023
`Page 9
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`

`

`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 pudenda! 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,
`
`LUMENIS EX1023
`Page 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 o_f 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 pudenda} 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.
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`In an alternative embodiment of the device, the LC can be powered by a fixed power source (e.g.
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`plugging the device into a traditional outlet in the wall).
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`[0029] Despite the name LOFIT, it is important to note that any frequency of stimulation may
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`be delivered by" the present invention including, but not limited to, low-frequency, high(cid:173)
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`frequency, mid-frequency, ultrahigh frequency, etc. Furthermore, non-overlapping coils may
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`also be used to generate the desired field, although overlapping or Helmholtz coils are ideal in
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`their ability to target a broader region and achieve more thorough stimulation.
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`(0030] Furthermore, while this summary has focused on the device and methods for
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`stimulating the posterior tibial nerve and peripheral nerves related to the sacral and pudenda!
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`nerves for incontinence therapy, it may also be used for other peripheral and central nerve
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`stimulation, so long as the stimulating coil or coils are at least in part controlled by automated
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`feedback from the nerve conduction sensor and/or patient feedback described above. Thus, the
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`coil or coils may be reversibly locked into an optimally targeted configuration within their
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`ergonomic, body-contoured, wrap or cradle.
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`[0031] Potential indications for which this therapy has been validated or may hold promise are
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`broad including obesity, depression, urinary incontinence, fecal incontinence, hypertension, pain,
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`back pain, restless leg syndrome, Guillain Barre syndrome, quadriplegia, paraplegia, diabetic
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`polyneuropthy, dyskinesias, paresthesias, Dental procedure pain, Knee osteoarthritis, Anesthesia
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`(pain relief during surgery), Alzheimer's disease, Angina (chest pain from heart disease),
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`Ankylosing spondylitis, Back pain, Burn· pain, Cancer pain, Chronic pain, Dysmenorrhea
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`(painful menstruation), Headache, Hemiplegia, hemiparesis (paralysis on one side of the body),
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`Labor pain, Local anesthesia during gallstone lithotripsy, Facial pain, trigeminal neuralgia,
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`bruxism (tooth grinding) pain, Myofascial pain, Pregnancy-related nausea or_vomiting, Neck and
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`shoulder pain, Pain from broken bones, rib fracture or acute trauma, Diabetic peripheral
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`neuropathy, Phantom.limb pain, Post-herpetic neuralgia (pain after shingles), Postoperative ileus
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`(bowel obstruction), Irritable Bowel Syndrome, Postoperative nausea or vomiting, Postoperative
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`pain, Post-stroke rehabilitation, Rheumatoid arthritis, Skin ulcers, Spinal cord
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`injury,
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`Temporomandibular joint pain, Urinary incontinence, overactive bladder, detrusor instability,
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`Spinal muscular atrophy (in children), Pain during hysteroscopy, Gastroparesis, Chronic
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`· obstructive pulmonary disease rehabilitation, Carpal tunnel syndrome, Soft tissue injury,
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`Multiple sclerosis, Intermittent claudication, Attention-deficit hyperactivity disorder (ADHD),
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`Cognitive impairment, Knee replacement pain, Achalasia, Atopic eczema, Bursitis, Carpal tunnel
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`syndrome, Dementia, Depression, Dry mouth, Dystonia, Enhanced blood flow in the brain,
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`LUMENIS EX1023
`Page 12
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`Enhanced blood perfusion of the uterus and placenta, Esophageal spasm, Fibromyalgia, Fracture
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`pain, Guillain-Barre syndrome, Hemophilia, Herpes, Hip pain, Interstitial cystitis, Irritable bowel
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`syndrome, Pruritis, Joint pain, Labor induction, Local anesthesia, Menstrual cramps, Muscle
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`cramps, Muscle spasticity, Muscle strain or pain, Musculoskeletal trauma,· Myofascial pain
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`dysfunction syndrome, Nerve damage, Osteoarthritis, Pain medication adjunct, Pancreatitis,
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`Raynaud's phenomenon, Repetitive strain injuries, Sacral pain, Schizophrenia, Shingles,
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`Shoulder subluxation, Sickle cell anemia pain, Skin flap ischemia (during plastic surgery),
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`Sphincter of Oddi disorders, Sports injuries, Thrombophlebitis, Tinnitus (ringing in the ear),
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`Restless Legs, Tremor, Whiplash and Neuralgias. Once the target nerve has been identified, ie
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`the vagal nerve for hypertension, the patient need simply apply the device with the
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`ergonomically targeted coils and nerve conduction sensor to allow for repeatable, consistent
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`neuromodulation based on sensor feedback to ensure proper nerve conduction has been achieved
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`for the duration of the therapy.
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`In contrast to implantable nerve ·stin;rnlators, this therapy is
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`completely non-invasive and does not require a major surgery to implant a permanent nerve
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`stimulation device. In contrast to existing peripheral nerve stimulation technology (magnetic and
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`electrical), as w