`
`111111111111111111111111111111111! uui,11!1011,1!1Alli111111111111111111111110111111
`
`US 200803 06325A1
`
`(19) United States
`(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2008/0306325 A1
`(12) Patent Application Publication (10) Pub. No.: US 2008/0306325 Al
`Dec. 11, 2008
`(43) Pub. Date:
`Dec. 11, 2008
`Burnett et al.
`Burnett et al.
`(43) Pub. Date:
`
`(54) METHOD AND APPARATUS FOR MAGNETIC
`(54) METHOD AND APPARATUS FOR MAGNETIC
`INDUCTION THERAPY
`INDUCTION THERAPY
`
`(75) Inventors:
`Inventors:
`(75)
`
`Daniel R. Burnett, San Francisco,
`Daniel R. Burnett, San Francisco,
`CA (US); Christopher
`CA (US); Christopher
`Hermanson, Santa Cruz, CA (US)
`Hermanson, Santa Cruz, CA (US)
`Correspondence Address:
`Correspondence Address:
`Mitchell P. Brook
`Mitchell P. Brook
`LUCE, FORWARD, HAMILTON & SCRIPPS
`LUCE, FORWARD, HAMILTON & SCRIPPS
`LLP
`LLP
`11988 EL CAMINO REAL SUITE 200
`11988 EL CAMINO REAL, SUITE 200
`SAN DIEGO, CA 92130 (US)
`SAN DIEGO, CA 92130 (US)
`(73) Assignee:
`EMKinetics, Santa Cruz, CA (US)
`Assignee:
`(73)
`EMKinetics, Santa Cruz, CA (US)
`(21) Appl. No.:
`11/866,329
`Appl. No.:
`(21)
`11/866,329
`
`(22) Filed:
`Filed:
`(22)
`
`Oct. 2, 2007
`Oct. 2, 2007
`Related U.S. Application Data
`Related U.S. Application Data
`(60) Provisional application No. 60/848,720, filed on Oct.
`(60) Provisional application No. 60/848,720, filed on Oct.
`2, 2006.
`2, 2006.
`
`Publication Classification
`Publication Classification
`
`(51) Int. Cl.
`(51) Int. Cl.
`(2006.01)
`A6IN 2/02
`(2006.01)
`A61N 2/02
`(52) U.S. Cl. .......................................................... 6OO/13
`600/13
`(52) U.S. Cl.
`
`ABSTRACT
`(57)
`ABSTRACT
`(57)
`An energy emittingapparatus for providing a medical therapy
`An energy emitting apparatus for providing a medical therapy
`includes one or more energy generators, a logic controller
`includes one or more energy generators, a logic controller
`electrically connected to the one or more energy generators,
`electrically connected to the one or more energy generators,
`and one or more sensors for detecting electric conduction in a
`and one or more sensors for detecting electric conduction in a
`target nerve that are connected to the logic controller. The one
`target nerve that are connected to the logic controller. The one
`or more energy generators produce energy focused on the
`or more energy generators produce energy focused on the
`target nerve upon receiving a signal from the logic controller,
`target nerve upon receiving a signal from the logic controller,
`and the energy is varied by the logic controller according to an
`and the energy is varied by the logic controller according to an
`input provided by the one or more sensors. In one embodi
`input provided by the one or more sensors. In one embodi-
`ment, the energy emitting apparatus is an apparatus for mag
`ment, the energy emitting apparatus is an apparatus for mag-
`netic induction therapy that includes one or more conductive
`netic induction therapy that includes one or more conductive
`coils disposed in an ergonomic housing that produce a mag
`coils disposed in an ergonomic housing that produce a mag-
`netic field focused on the target nerve upon receiving an
`netic field focused on the target nerve upon receiving an
`electric current from the logic controller based on an input
`electric current from the logic controller based on an input
`provided by the one or more sensors.
`provided by the one or more sensors.
`
`
`
`24
`30
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`22
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`6
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`20
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`32
`
`Petitioner - Avation Medical, Inc.
`Ex. 1006, p. 1
`
`

`

`Patent Application Publication
`Dec. 11, 2008 Sheet 1 of 8
`Patent Application Publication Dec. 11, 2008 Sheet 1 of 8
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`US 2008/0306325 A1
`US 2008/0306325 Al
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`28
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`42
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`24
`30
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`22
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`26
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`20
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`32
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`FIG. 1
`FIG. 1
`
`
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`36
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`38
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`44
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`34
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`40
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`F/G. 2
`FIG. 2
`
`Petitioner - Avation Medical, Inc.
`Ex. 1006, p. 2
`
`

`

`Patent Application Publication
`Dec. 11, 2008 Sheet 2 of 8
`Patent Application Publication Dec. 11, 2008 Sheet 2 of 8
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`US 2008/0306325 A1
`US 2008/0306325 Al
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`
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`1
`
`)
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`48
`
`46
`
`FIG. 3
`FIG. 3
`
`Petitioner - Avation Medical, Inc.
`Ex. 1006, p. 3
`
`

`

`Patent Application Publication
`Dec. 11, 2008 Sheet 3 of 8
`Patent Application Publication Dec. 11, 2008 Sheet 3 of 8
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`US 2008/0306325 A1
`US 2008/0306325 Al
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`50
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`48-
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`54
`55
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`56
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`52 N
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`64
`
`FIG. 4
`
`58
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`I
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`60
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`62
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`66
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`FIG. 5
`
`Petitioner - Avation Medical, Inc.
`Ex. 1006, p. 4
`
`

`

`Patent Application Publication
`Dec. 11, 2008 Sheet 4 of 8
`Patent Application Publication Dec. 11, 2008 Sheet 4 of 8
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`US 2008/0306325 A1
`US 2008/0306325 Al
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`
`
`0
`
`CD
`
`03
`
`07)
`
`09 '914
`
`Petitioner - Avation Medical, Inc.
`Ex. 1006, p. 5
`
`

`

`Patent Application Publication
`Dec. 11, 2008 Sheet 5 of 8
`Patent Application Publication Dec. 11, 2008 Sheet 5 of 8
`
`US 2008/0306325 A1
`US 2008/0306325 Al
`
`
`
`(.0
`Co
`
`s
`CS
`
`CO
`
`CO
`
`S
`S
`l
`
`S
`CS
`
`S
`S
`b.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1006, p. 6
`
`

`

`Patent Application Publication
`Dec. 11, 2008 Sheet 6 of 8
`Patent Application Publication Dec. 11, 2008 Sheet 6 of 8
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`US 2008/0306325 A1
`US 2008/0306325 Al
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`
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`94
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`98
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`96
`
`FIG. 8
`
`Petitioner - Avation Medical, Inc.
`Ex. 1006, p. 7
`
`

`

`Patent Application Publication
`Dec. 11, 2008 Sheet 7 of 8
`Patent Application Publication Dec. 11, 2008 Sheet 7 of 8
`
`US 2008/0306325 A1
`US 2008/0306325 Al
`
`
`
`CO
`00
`3.
`Yax
`
`Petitioner - Avation Medical, Inc.
`Ex. 1006, p. 8
`
`

`

`Patent Application Publication
`Dec. 11, 2008 Sheet 8 of 8
`Patent Application Publication Dec. 11, 2008 Sheet 8 of 8
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`US 2008/0306325 A1
`US 2008/0306325 Al
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`
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`128
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`130
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`134
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`7-
`
`)
`
`138
`
`FIG. 10
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`136
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`126
`
`FIG. 11
`FIG. 11
`
`Petitioner - Avation Medical, Inc.
`Ex. 1006, p. 9
`
`

`

`US 2008/0306325 A1
`US 2008/0306325 Al
`
`1
`
`Dec. 11, 2008
`Dec. 11, 2008
`
`METHOD AND APPARATUS FOR MAGNETC
`METHOD AND APPARATUS FOR MAGNETIC
`INDUCTION THERAPY
`INDUCTION THERAPY
`
`CROSS-REFERENCE TO RELATED
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`APPLICATIONS
`0001. The present application claims priority to U.S. Pro
`[0001] The present application claims priority to U.S. Pro-
`visional Patent Application Ser. No. 60/848,720, filed on Oct.
`visional Patent Application Ser. No. 60/848,720, filed on Oct.
`2, 2006 and titled: "Method and Apparatus for Magnetic
`2, 2006 and titled: "Method and Apparatus for Magnetic
`Induction Therapy.”
`Induction Therapy."
`
`FIELD OF THE INVENTION
`FIELD OF THE INVENTION
`0002 The present invention relates to energy emitting
`[0002] The present invention relates to energy emitting
`apparatus and methods for providing a medical therapy. In
`apparatus and methods for providing a medical therapy. In
`one embodiment, the energy emitting apparatus is an ergo
`one embodiment, the energy emitting apparatus is an ergo-
`nomic wrap or cradle that contains conductive coils generat
`nomic wrap or cradle that contains conductive coils generat-
`ing a magnetic field directed to a target nerve.
`ing a magnetic field directed to a target nerve.
`
`BACKGROUND OF THE INVENTION
`BACKGROUND OF THE INVENTION
`0003. Overactive bladder (“OAB) and urinary inconti
`[0003] Overactive bladder ("OAB") and urinary inconti-
`nence (“UI”) affect over 16% of the American population
`nence ("UI") affect over 16% of the American population
`each year, or approximately 34 million men and women.
`each year, or approximately 34 million men and women.
`Outside of the United States, OAB and UI affects over 46
`Outside of the United States, OAB and UI affects over 46
`million Europeans. The economic cost of OAB and UI is
`million Europeans. The economic cost of OAB and UI is
`estimated to be in excess of S12 billion a year in the United
`estimated to be in excess of $12 billion a year in the United
`States alone.
`States alone.
`0004. Due to the social stigmas attached to OAB and UI
`[0004] Due to the social stigmas attached to OAB and UI
`and to misunderstandings related to the symptoms associated
`and to misunderstandings related to the symptoms associated
`with OAB and UI, only 40% of the affected individuals in the
`with OAB and UI, only 40% of the affected individuals in the
`United States seek medical treatment. Of those 13.6 million
`United States seek medical treatment. Of those 13.6 million
`Americans seeking medical treatment, nearly 30% or 4 mil
`Americans seeking medical treatment, nearly 30% or 4 mil-
`lion individuals are reportedly unsatisfied with their current
`lion individuals are reportedly unsatisfied with their current
`therapy.
`therapy.
`0005 Known treatments for OAB and UI include exercise
`[0005] Known treatments for OAB and UI include exercise
`and behavioral modifications, pharmacological therapies,
`and behavioral modifications, pharmacological therapies,
`Surgical intervention and neuromodulation, but each of these
`surgical intervention and neuromodulation, but each of these
`treatments exhibits severe limitations.
`treatments exhibits severe limitations.
`0006 Exercise and behavioral modifications often require
`[0006] Exercise and behavioral modifications often require
`patients to adhere to stringent routines, including scheduled
`patients to adhere to stringent routines, including scheduled
`Voiding, maintenance of a bladder diary, and intense exercise
`voiding, maintenance of a bladder diary, and intense exercise
`regimens. While this type of treatment may be a viable option
`regimens. While this type of treatment may be a viable option
`for a small group of highly dedicated individuals, its daily
`for a small group of highly dedicated individuals, its daily
`impact on a person’s life makes it unattractive for most
`impact on a person's life makes it unattractive for most
`patients.
`patients.
`0007 Pharmacological intervention is the most widely
`[0007] Pharmacological intervention is the most widely
`prescribed therapy for OAB and UI. Unfortunately, patients
`prescribed therapy for OAB and UI. Unfortunately, patients
`often suffer from side effects related to their drug therapies.
`often suffer from side effects related to their drug therapies.
`Such side effects are sometimes serious and are particularly
`Such side effects are sometimes serious and are particularly
`pronounced in elderly patient populations that tend to use a
`pronounced in elderly patient populations that tend to use a
`plurality of medications. In addition, approximately 30% of
`plurality of medications. In addition, approximately 30% of
`all patients subjected to pharmacological therapies appear to
`all patients subjected to pharmacological therapies appear to
`be dissatisfied with the efficacy of their prescribed treatments.
`be dissatisfied with the efficacy of their prescribed treatments.
`0008 Surgical intervention is extremely invasive and
`[0008] Surgical intervention is extremely invasive and
`often results in a long-term requirement for catheterization
`often results in a long-term requirement for catheterization
`that may become permanent in Some instances. The negative
`that may become permanent in some instances. The negative
`impact of these procedures on the patient’s quality of life and
`impact of these procedures on the patient's quality of life and
`their high expense make Surgical intervention a recom
`their high expense make surgical intervention a recom-
`mended option only when all other treatment options have
`mended option only when all other treatment options have
`been exhausted.
`been exhausted.
`0009 Neuromodulation is another available therapy for
`[0009] Neuromodulation is another available therapy for
`OAB and UI. In general, pulsed electromagnetic stimulation
`OAB and UI. In general, pulsed electromagnetic stimulation
`(“PES) has proven to have beneficial effects in a variety of
`("PES") has proven to have beneficial effects in a variety of
`medical applications. The related Scientific principle is that an
`medical applications. The related scientific principle is that an
`electric current passing through a coil generates an electro
`electric current passing through a coil generates an electro-
`
`magnetic field, which induces a current within a conductive
`magnetic field, which induces a current within a conductive
`material placed inside the electromagnetic field.
`material placed inside the electromagnetic field.
`(0010 More particularly, PES has been shown to be an
`[0010] More particularly, PES has been shown to be an
`effective method of stimulating a nerve positioned within the
`effective method of stimulating a nerve positioned within the
`electromagnetic field, thereby affecting a muscle controlled
`electromagnetic field, thereby affecting a muscle controlled
`by that nerve. For example, in the paper titled “Contactless
`by that nerve. For example, in the paper titled "Contactless
`Nerve Stimulation and Signal Detection by Inductive Trans
`Nerve Stimulation and Signal Detection by Inductive Trans-
`ducer presented at the 1969 Symposium on Application of
`ducer" presented at the 1969 Symposium on Application of
`Magnetism in Bioengineering, Maass et al. disclosed that a
`Magnetism in Bioengineering, Maass et al. disclosed that a
`nerve threading the lumen of a toroid could be stimulated by
`nerve threading the lumen of a toroid could be stimulated by
`a magnetic field of 0.7 Volt peak amplitude and a 50 us
`a magnetic field of 0.7 Volt peak amplitude and a 50 µs
`duration in a monitor wire, and that such stimulation could
`duration in a monitor wire, and that such stimulation could
`generate a contraction of major leg muscles in anesthetized
`generate a contraction of major leg muscles in anesthetized
`mammals.
`mammals.
`0011
`Various attempts were made in the prior art to use
`[0011] Various attempts were made in the prior art to use
`PES for treating a variety of ailments. For example, U.S. Pat.
`PES for treating a variety of ailments. For example, U.S. Pat.
`No. 4.548,208 to Niemi discloses an apparatus for inducing
`No. 4,548,208 to Niemi discloses an apparatus for inducing
`bone growth by generating an electric current in the body
`bone growth by generating an electric current in the body
`through the external application of an electromagnetic field.
`through the external application of an electromagnetic field.
`Such apparatus includes opposing clamps disposed on a limb
`Such apparatus includes opposing clamps disposed on a limb
`and may optionally include feedback coils and a micropro
`and may optionally include feedback coils and a micropro-
`cessor for sensing the magnetic field, so to avoid an overcur
`cessor for sensing the magnetic field, so to avoid an overcur-
`rent mode. Therefore, this apparatus optimizes the magnetic
`rent mode. Therefore, this apparatus optimizes the magnetic
`field on the basis of measurements of the generated magnetic
`field on the basis of measurements of the generated magnetic
`field.
`field.
`0012 U.S. Pat. No. 4,940,453 to Cadwell discloses a
`[0012] U.S. Pat. No. 4,940,453 to Cadwell discloses a
`method and apparatus for magnetically stimulating the neural
`method and apparatus for magnetically stimulating the neural
`pathways of a higher level organism. In this invention, a
`pathways of a higher level organism. In this invention, a
`sinusoidally fluctuating current flow is created through a coil
`sinusoidally fluctuating current flow is created through a coil
`that overlies neurons to be stimulated, and frequency of the
`that overlies neurons to be stimulated, and frequency of the
`current flow and frequency of the magnetic field produced by
`current flow and frequency of the magnetic field produced by
`the coil predetermined to correspond to the time constant of
`the coil predetermined to correspond to the time constant of
`the neurons to be stimulated. Sensors for sensing coil condi
`the neurons to be stimulated. Sensors for sensing coil condi-
`tions, such as coil temperature, may also be included.
`tions, such as coil temperature, may also be included.
`0013 U.S. Pat. No. 5,000, 178 to Griffith discloses an elec
`[0013] U.S. Pat. No. 5,000,178 to Griffith discloses an elec-
`trical to electromagnetic transducer for applying electromag
`trical to electromagnetic transducer for applying electromag-
`netic energy to damaged parts of a living body by directing
`netic energy to damaged parts of a living body by directing
`electromagnetic radiation to a certain damaged body part.
`electromagnetic radiation to a certain damaged body part.
`Electromagnetic radiation is initially generated by a dipole
`Electromagnetic radiation is initially generated by a dipole
`consisting of a bar of high permeability material wrapped
`consisting of a bar of high permeability material wrapped
`with an electrically conductive coil. Magnetic fields, which
`with an electrically conductive coil. Magnetic fields, which
`are generated away from the damaged body part, intersect a
`are generated away from the damaged body part, intersect a
`conductive shield and establish eddy currents, which in turn
`conductive shield and establish eddy currents, which in turn
`generate magnetic fields opposite and nearly equal to the
`generate magnetic fields opposite and nearly equal to the
`magnetic fields generated by the electromagnetic source. The
`magnetic fields generated by the electromagnetic source. The
`resultant electromagnetic fields reinforce the electromagnetic
`resultant electromagnetic fields reinforce the electromagnetic
`field directed towards the damaged body part and diminish
`field directed towards the damaged body part and diminish
`the electromagnetic field directed away from the damaged
`the electromagnetic field directed away from the damaged
`body part.
`body part.
`0014 U.S. Pat. No. 5,014,699 to Pollacket al. discloses a
`[0014] U.S. Pat. No. 5,014,699 to Pollack et al. discloses a
`non-invasive, portable electromagnetic therapeutic method
`non-invasive, portable electromagnetic therapeutic method
`and apparatus for promoting the healing of damaged or dis
`and apparatus for promoting the healing of damaged or dis-
`eased living tissue, including fractured bone. These method
`eased living tissue, including fractured bone. These method
`and apparatus involve generating a signal that has a series of
`and apparatus involve generating a signal that has a series of
`Substantially symmetric Voltage cycles ofbursted pulses with
`substantially symmetric voltage cycles of bursted pulses with
`narrow pulse widths of 0.5 to 20 microseconds, and further
`narrow pulse widths of 0.5 to 20 microseconds, and further
`involve converting the signal into an electromagnetic field
`involve converting the signal into an electromagnetic field
`extending into an area that contains tissue to be healed. This
`extending into an area that contains tissue to be healed. This
`invention provides for no feedback on the efficiency of the
`invention provides for no feedback on the efficiency of the
`applied stimulation.
`applied stimulation.
`0015. In a paper titled “Selective Stimulation and Block
`[0015]
`In a paper titled "Selective Stimulation and Block-
`ing of Sacral Nerves: Research Setup and Preliminary
`ing of Sacral Nerves: Research Setup and Preliminary
`Results.” published in Annual International Conference of the
`Results," published in Annual International Conference of the
`IEEE Engineering in Medicine and Biology Society, Vol. 13,
`IEEE Engineering in Medicine and Biology Society, Vol. 13,
`
`Petitioner - Avation Medical, Inc.
`Ex. 1006, p. 10
`
`

`

`US 2008/0306325 A1
`US 2008/0306325 Al
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`2
`
`Dec. 11, 2008
`Dec. 11, 2008
`
`No. 2, 1991, Wijkstrala et al. used an external pulsed magnetic
`No. 2, 1991, Wijkstrda et al. used an external pulsed magnetic
`coil to stimulate a peripheral nerve for the treatment of uri
`coil to stimulate a peripheral nerve for the treatment of uri-
`nary incontinence. The authors used a large magnetic field
`nary incontinence. The authors used a large magnetic field
`produced by a single coil to ensure that the nerve was fired and
`produced by a single coil to ensure that the nerve was fired and
`the resulting nerve conduction was frequently painful or
`the resulting nerve conduction was frequently painful or
`intolerable. In addition, coil alignment was problematic
`intolerable. In addition, coil alignment was problematic
`because an internally implanted coil was utilized, which had
`because an internally implanted coil was utilized, which had
`to be aligned with the fully external magnetic field to stimu
`to be aligned with the fully external magnetic field to stimu-
`late the nerve. Due to the difficulty in positioning the device,
`late the nerve. Due to the difficulty in positioning the device,
`the practical application of this therapy does not permit home
`the practical application of this therapy does not permit home
`healthcare usage without a preset alignment and monitoring
`healthcare usage without a preset alignment and monitoring
`of the nerve, and no provision was made to insure that the
`of the nerve, and no provision was made to insure that the
`nerve was actually being stimulated or to adjust the device in
`nerve was actually being stimulated or to adjust the device in
`response to commonly occurring physiologic and anatomic
`response to commonly occurring physiologic and anatomic
`variations in nerve locations.
`variations in nerve locations.
`0016 U.S. Pat. Nos. 5,181,902 Erickson et al. and 5,314,
`[0016] U.S. Pat. Nos. 5,181,902 Erickson et al. and 5,314,
`401 to Tepper disclose pulsed electromagnetic field
`401
`to Tepper disclose pulsed electromagnetic
`field
`(“PEMF) transducer systems usable to perform PEMF
`("PEMF") transducer systems usable to perform PEMF
`therapies (such as after spinal fusion) by generating flux
`therapies (such as after spinal fusion) by generating flux-
`aided electromagnetic fields. The drive electronics includes a
`aided electromagnetic fields. The drive electronics includes a
`PEMF processor that executes a PEMF program for control
`PEMF processor that executes a PEMF program for control-
`ling the activation of the electromagnetic fields (field strength
`ling the activation of the electromagnetic fields (field strength
`and cycle).
`and cycle).
`0017. In a paper titled: “Magnetic Stimulation of the Blad
`[0017]
`In a paper titled: "Magnetic Stimulation of the Blad-
`der in Dogs’ presented at the 1993 AAEM Annual Meeting,
`der in Dogs" presented at the 1993 AAEM Annual Meeting,
`the abstract of which was published in the Muscle & Nerve
`the abstract of which was published in the Muscle & Nerve
`issue of October 1993, Lin et al. disclosed that magnetic
`issue of October 1993, Lin et al. disclosed that magnetic
`stimulation could be employed to stimulate the cortex, spinal
`stimulation could be employed to stimulate the cortex, spinal
`nerves and peripheral nerves of dogs through direct trans
`nerves and peripheral nerves of dogs through direct trans-
`abdominal stimulation of the detrusor muscles or through
`abdominal stimulation of the detrusor muscles or through
`stimulation of the lumbosacral roots.
`stimulation of the lumbosacral roots.
`0018. As shown, the prior art makes no provision to mea
`[0018] As shown, the prior art makes no provision to mea-
`sure the efficacy of PES treatment, causing patients to be
`sure the efficacy of PES treatment, causing patients to be
`treated improperly, either by an insufficient or excessive
`treated improperly, either by an insufficient or excessive
`exposure to PES. Other attempts to monitor PES dosage in the
`exposure to PES. Other attempts to monitor PES dosage in the
`prior art exhibit serious drawbacks. For example, U.S. Pat.
`prior art exhibit serious drawbacks. For example, U.S. Pat.
`No. 5.518,495 to Kot discloses an apparatus for the treatment
`No. 5,518,495 to Kot discloses an apparatus for the treatment
`of arthritis utilizing a magnetic field therapy, which includes
`of arthritis utilizing a magnetic field therapy, which includes
`an adjustable Voltage source that is connected to a source of
`an adjustable voltage source that is connected to a source of
`line Voltage and a coil connected to the adjustable Voltage
`line voltage and a coil connected to the adjustable voltage
`Source. This apparatus has no feedback system to advise a
`source. This apparatus has no feedback system to advise a
`healthcare provider of the efficiency of the treatment.
`healthcare provider of the efficiency of the treatment.
`00.19
`U.S. Pat. No. 5,984.854 to Ishikawa et al. discloses
`[0019] U.S. Pat. No. 5,984,854 to Ishikawa et al. discloses
`a method for treating urinary incontinence based on deliver
`a method for treating urinary incontinence based on deliver-
`ing a train of current pulses through one or more magnetic
`ing a train of current pulses through one or more magnetic
`stimulation coils so to induce a train of magnetic flux pulses,
`stimulation coils so to induce a train of magnetic flux pulses,
`which then induce an eddy current within the body and stimu
`which then induce an eddy current within the body and stimu-
`lates a group of pelvic floor muscles, the pudendal nerve, the
`lates a group of pelvic floor muscles, the pudendal nerve, the
`external urethral sphincter, or the tibial nerve. While this
`external urethral sphincter, or the tibial nerve. While this
`method includes the use of pulsed electromagnetic for treat
`method includes the use of pulsed electromagnetic for treat-
`ing urinary incontinence, no specific components are envi
`ing urinary incontinence, no specific components are envi-
`Sioned to facilitate the placement of the magnetic coils over a
`sioned to facilitate the placement of the magnetic coils over a
`targeted region of the body or a system for monitoring the
`targeted region of the body or a system for monitoring the
`efficiency of the therapy being applied.
`efficiency of the therapy being applied.
`0020 U.S. Pat. No. 6,086,525 to Davey et al. discloses a
`[0020] U.S. Pat. No. 6,086,525 to Davey et al. discloses a
`magnetic nerve stimulator that includes a core constructed
`magnetic nerve stimulator that includes a core constructed
`from a material having a high field Saturation having a coil
`from a material having a high field saturation having a coil
`winding disposed thereon. A thyrister capacitive discharge
`winding disposed thereon. A thyrister capacitive discharge
`circuit pulses the device, and a rapidly changing magnetic
`circuit pulses the device, and a rapidly changing magnetic
`field is guided by the core, preferably made from vanadium
`field is guided by the core, preferably made from vanadium
`permendur.
`permendur.
`0021 U.S. Pat. No. 6,701,185 to Burnett et al. also dis
`[0021] U.S. Pat. No. 6,701,185 to Burnett et al. also dis-
`closes an electromagnetic stimulation device that includes a
`closes an electromagnetic stimulation device that includes a
`plurality of overlapping coils, which can be independently
`plurality of overlapping coils, which can be independently
`
`energized in a predetermined sequence Such that each coil
`energized in a predetermined sequence such that each coil
`will generate its own independent electromagnetic field and
`will generate its own independent electromagnetic field and
`significantly increase the adjacent field. Unfortunately, none
`significantly increase the adjacent field. Unfortunately, none
`of these patents provides a system for monitoring the effi
`of these patents provides a system for monitoring the effi-
`ciency of the therapy in progress, either with respect to the
`ciency of the therapy in progress, either with respect to the
`proper positioning of the winding over the area to be treated
`proper positioning of the winding over the area to be treated
`or of the intensity of the magnetic field to be applied.
`or of the intensity of the magnetic field to be applied.
`0022. Other PES therapies require the implantation of
`[0022] Other PES therapies require the implantation of
`devices into the patient, with the consequent discomfort, risk
`devices into the patient, with the consequent discomfort, risk
`and cost to the patient. For example, U.S. Pat. No. 6,735,474
`and cost to the patient. For example, U.S. Pat. No. 6,735,474
`to Loeb et al. discloses a method and system for treating UI
`to Loeb et al. discloses a method and system for treating UI
`and/or pelvic pain by injecting or laparoscopically implanting
`and/or pelvic pain by injecting or laparoscopically implanting
`one or more battery- or radio frequency-powered microstimu
`one or more battery- or radio frequency-powered micro stimu-
`lators that include electrodes placed beneath the skin of the
`lators that include electrodes placed beneath the skin of the
`perineum and/or adjacent the tibial nerve.
`perineum and/or adjacent the tibial nerve.
`0023 U.S. Pat. No. 6,941,171 to Mann et al. describes a
`[0023] U.S. Pat. No. 6,941,171 to Mann et al. describes a
`method and a system for treating incontinence, urgency, fre
`method and a system for treating incontinence, urgency, fre-
`quency, and/or pelvic pain that includes implantation of elec
`quency, and/or pelvic pain that includes implantation of elec-
`trodes on a lead or a discharge portion of a catheter adjacent
`trodes on a lead or a discharge portion of a catheter adjacent
`the perineal nerves) or tissue(s) to be stimulated. Stimulation
`the perineal nerve(s) or tissue(s) to be stimulated. Stimulation
`pulses, either electrical or drug infusion pulses, are Supplied
`pulses, either electrical or drug infusion pulses, are supplied
`by a stimulator implanted remotely through the lead or cath
`by a stimulator implanted remotely through the lead or cath-
`eter, which is tunneled subcutaneously between the stimula
`eter, which is tunneled subcutaneously between the stimula-
`tor and stimulation site.
`tor and stimulation site.
`(0024. Other PES therapies in the prior art involve the use
`[0024] Other PES therapies in the prior art involve the use
`of electrodes placedonor beneath the skin of a patient. Recent
`of electrodes placed on or beneath the skin of a patient. Recent
`data on invasive, needle-based PES of the posterior tibial
`data on invasive, needle-based PES of the posterior tibial
`nerve in individuals with OAB and UI indicates that PES can
`nerve in individuals with OAB and UI indicates that PES can
`modulate bladder dysfunction through its action on the
`modulate bladder dysfunction through its action on the
`pudendal nerve and the Sacral plexus, which provide the
`pudendal nerve and the sacral plexus, which provide the
`major excitatory input to the bladder.
`major excitatory input to the bladder.
`(0025. In a paper titled “Percutaneous Tibial Nerve Stimu
`[0025]
`In a paper titled "Percutaneous Tibial Nerve Stimu-
`lation via Urgent(R) PC Neuromodulation System. An
`lation via Urgent® PC Neuromodulation System An
`Emerging Technology for managing Overactive Bladder.”
`Emerging Technology for managing Overactive Bladder,"
`which was published in Business Briefing: Global Surgery
`which was published in Business Briefing: Global Surgery
`2004, CystoMedix, Inc. disclosed that peripheral tibial nerve
`2004, CystoMedix, Inc. disclosed that peripheral tibial nerve
`stimulation (“PTNS) had been found effective in treating
`stimulation ("PTNS") had been found effective in treating
`OAB. The disclosed procedure involved the use of electrode
`OAB. The disclosed procedure involved the use of electrode
`and generator components, including a small 34-gauge
`and generator components, including a small 34-gauge
`needle electrode, lead wires and a hand-held electrical gen
`needle electrode, lead wires and a hand-held electrical gen-
`erator. However, the procedure requires the permanent
`erator. However, the procedure requires the permanent
`implantation of an electrical stimulation device in the patient.
`implantation of an electrical stimulation device in the patient.
`One estimate put the cost of treatment at nearly $14,000 with
`One estimate put the cost of treatment at nearly $14,000 with
`additional routine care costs of S593 per patient per year.
`additional routine care costs of $593 per patient per year.
`Additionally, risks of battery failure, implant infection, and
`Additionally, risks of battery failure, implant infection, and
`electrode migration led to a high re-operation rate and made
`electrode migration led to a high re-operation rate and made
`this procedure unattractive.
`this procedure unattractive.
`(0026 U.S. Pat. No. 7,117,034 to Kronberg discloses a
`[0026] U.S. Pat. No. 7,117,034 to Kronberg discloses a
`method for generating an electrical signal for use in biomedi
`method for generating an electrical signal for use in biomedi-
`cal applica