Implantable electroacupuncture device and method for treating depression, bipolar disorder and anxiety
First Claim
1. An Implantable ElectroAcupuncture Device (IEAD) for treating depression, bipolar disorder, or anxiety, adapted for application of electroacupuncture (EA) stimulation pulses substantially at or near at least one of acupoints GV20 and EXHN3 of a patient, comprising:
- a small, thin, leadless coin-sized and coin-shaped IEAD housing having a symmetrical electrode configuration thereon that includes at least two electrodes/arrays, a longest linear dimension of the IEAD housing being no greater than about 25 mm, wherein at least one of said at least two electrodes/arrays comprises a central electrode/array located substantially in a center of a first surface of the IEAD housing, and wherein at least another of said at least two electrodes/arrays comprises a circumferential electrode/array located substantially around and at least 5 mm distant from the center of the central electrode/array, wherein the first surface of the IEAD housing when implanted is adapted to face selected target tissue at or near at least one of acupoints GV20 and EXHN3;
pulse generation circuitry located within the IEAD housing and electrically coupled to the at least two electrodes/arrays, wherein said pulse generation circuitry, once turned on, is adapted to continuously deliver stimulation sessions in accordance with a specified stimulation regimen to the at least two electrodes/arrays adapted for placement at or near the patient'"'"'s body tissue near at least one of acupoints GV20 and EXHN3, said stimulation regimen defining the duration and rate at which a stimulation session is applied to the patient, said stimulation regimen requiring that the stimulation session have a duration of T3 minutes, where T3 is at least 10 minutes, and a rate of occurrence of once every T4 minutes, wherein the ratio of T3/T4 is no greater than 0.05, and wherein during each stimulation session EA stimulation pulses having one or more specified widths and amplitudes are generated at one or more specified rates;
a primary battery contained within the IEAD housing and electrically coupled to the pulse generation circuitry, said primary battery having a nominal output voltage of 3 volts, and an internal impedance greater than 5 ohms; and
a magnetic sensor contained within the IEAD housing responsive to a presence or absence of a magnetic field placed near the IEAD housing, the sensed presence/absence of the magnetic field in a prescribed sequence allowing the pulse generation circuitry to be turned on, thereby allowing limited external control of the IEAD.
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Accused Products
Abstract
An implantable electroacupuncture device (IEAD) treats depression, bipolar disorder or Anxiety through application of stimulation pulses applied at acupoints GV20 and/or EXHN3. The IEAD comprises an implantable, coin-sized, self-contained, leadless electroacupuncture device having at least two electrodes attached to an outside surface of its housing. The device generates stimulation pulses in accordance with a specified stimulation regimen. Power management circuitry within the device allows a primary battery, having a high internal impedance, to be used to power the device. The stimulation regimen generates stimulation pulses during a stimulation session of duration T3 minutes applied every T4 minutes. The duty cycle, or ratio T3/T4, is very low, no greater than 0.05. The low duty cycle and careful power management allow the IEAD to perform its intended function for several years.
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Citations
28 Claims
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1. An Implantable ElectroAcupuncture Device (IEAD) for treating depression, bipolar disorder, or anxiety, adapted for application of electroacupuncture (EA) stimulation pulses substantially at or near at least one of acupoints GV20 and EXHN3 of a patient, comprising:
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a small, thin, leadless coin-sized and coin-shaped IEAD housing having a symmetrical electrode configuration thereon that includes at least two electrodes/arrays, a longest linear dimension of the IEAD housing being no greater than about 25 mm, wherein at least one of said at least two electrodes/arrays comprises a central electrode/array located substantially in a center of a first surface of the IEAD housing, and wherein at least another of said at least two electrodes/arrays comprises a circumferential electrode/array located substantially around and at least 5 mm distant from the center of the central electrode/array, wherein the first surface of the IEAD housing when implanted is adapted to face selected target tissue at or near at least one of acupoints GV20 and EXHN3; pulse generation circuitry located within the IEAD housing and electrically coupled to the at least two electrodes/arrays, wherein said pulse generation circuitry, once turned on, is adapted to continuously deliver stimulation sessions in accordance with a specified stimulation regimen to the at least two electrodes/arrays adapted for placement at or near the patient'"'"'s body tissue near at least one of acupoints GV20 and EXHN3, said stimulation regimen defining the duration and rate at which a stimulation session is applied to the patient, said stimulation regimen requiring that the stimulation session have a duration of T3 minutes, where T3 is at least 10 minutes, and a rate of occurrence of once every T4 minutes, wherein the ratio of T3/T4 is no greater than 0.05, and wherein during each stimulation session EA stimulation pulses having one or more specified widths and amplitudes are generated at one or more specified rates; a primary battery contained within the IEAD housing and electrically coupled to the pulse generation circuitry, said primary battery having a nominal output voltage of 3 volts, and an internal impedance greater than 5 ohms; and a magnetic sensor contained within the IEAD housing responsive to a presence or absence of a magnetic field placed near the IEAD housing, the sensed presence/absence of the magnetic field in a prescribed sequence allowing the pulse generation circuitry to be turned on, thereby allowing limited external control of the IEAD. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A method of treating depression, bipolar disorder, or anxiety in a patient using a small, leadless, coin-sized and coin shaped implantable electroacupuncture device (IEAD) powered by a small disc primary battery having a specified nominal output voltage of 3 volts, and having an internal impedance of at least 5 ohms, the IEAD being configured, using self-contained electronic circuitry within the IEAD, to generate electroacupuncture (EA) stimulation pulses in accordance with a specified stimulation regimen and apply the EA stimulation pulses to at least two electrodes/arrays located on an outside surface of a housing of the IEAD and configured in a symmetrical pattern, said at least two electrodes/arrays comprising at least one central electrode/array of a first polarity, having a maximum width of no more 7 mm, centrally located on a first surface of the IEAD housing, and at least one annular electrode/array of a second polarity spaced apart from the central electrode/array by at least 5 mm measured from the edge of the annular electrode/array closest to the central electrode/array to the center of the central electrode/array, said method comprising:
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(a) implanting the IEAD below the skin surface of the patient at at least one acupoint selected from acupoints GV20 and EXHN3, with the first surface of the IEAD facing a target tissue location associated with the selected acupoint; (b) enabling the IEAD to provide stimulation pulses in accordance with a stimulation regimen that continuously provides a stimulation session at a rate of once every T4 minutes, with each stimulation session having a duration of T3 minutes, where T3 is at least 10 minutes, and where the ratio of T3/T4 is no greater than 0.05. - View Dependent Claims (14, 15, 16, 17, 18, 19)
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20. A method for treating depression, bipolar disorder or anxiety in a patient comprising the steps of:
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(a) implanting a small, thin, coin-sized and coin-shaped, leadless, electroacupuncture (EA) device in the patient below the patient'"'"'s skin at at least one specified acupoint; (b) enabling the EA device to generate stimulation sessions at a duty cycle that is less than or equal to 0.05, each stimulation session comprising a series of stimulation pulses, wherein the duty cycle is the ratio of T3/T4, where T3 is the duration in minutes of each stimulation session, wherein T3 is at least 10 minutes, and T4 is the time in minutes between stimulation sessions; and (c) continuously delivering the stimulation pulses of each stimulation session to the at least one specified acupoint through at least two electrodes/arrays attached to an outside surface of the EA device in a slow and methodical manner that is adapted to gradually condition and remodel the patient'"'"'s central nervous system so as to produce a sustained therapeutic benefit for patient. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27)
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28. A method of assembling an implantable electroacupuncture device (IEAD) for use in treating depression, bipolar disorder or anxiety in a thin, hermetically-sealed, coin-sized housing having at least one feed-through pin assembly radially passing through a wall of the coin-sized housing that isolates the feed-through pin assembly from high temperature damage that could occur when the coin-sized housing is welded shut to hermetically-seal its contents, the method comprising the steps of:
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(a) forming a coin-sized housing having a bottom case and a top cover plate, the top cover plate being adapted to fit over the bottom case, the bottom case having a longest linear dimension D2 of no more than about 25 mm and a perimeter side wall extending all the way around the perimeter of the bottom case, the perimeter side wall having a height W2, wherein the ratio of W2 to D2 is no greater than about 0.13; (b) forming a recess in one segment of the side wall, said recess extending radially inwardly from the side wall to a depth D3, said recess having an opening in a bottom wall portion thereof; (c) hermetically sealing a feed-through assembly in the opening in the bottom of the recess, the feed-through assembly having a feed-through pin that passes through the opening without contacting the edges of the opening, a distal end of the pin extending radially outward beyond the side wall of the bottom case, and a proximal end of the feed-through pin extending radially inward toward a center of the bottom case, whereby the feed-through assembly is hermetically bonded to the opening in the side wall at a location in the bottom of the recess that is located a distance D3 from the perimeter side wall, thereby thermally and mechanically isolating the feed-through assembly from high temperatures and residual weld stresses that occur at the perimeter side wall when the cover plate is welded to the edge of the perimeter side wall in step (e); (d) attaching a central electrode to the thin coin-sized housing at a central location on a bottom outside surface of the housing; (e) inserting an electronic circuit assembly, including a battery, inside of the bottom case, and connecting the proximal end of the feed-though pin to an output terminal of the electronic circuit assembly, and electrically connecting the bottom case to a reference terminal of the battery; (f) welding the top cover plate to the edges of the side wall of the bottom case, thereby hermetically sealing the electronic circuit assembly, including the battery, inside of the IEAD housing, the IEAD housing comprising the assembly resulting from welding the top cover plate to the bottom case, the top cover plate forming a top surface of the IEAD housing, and a surface of the IEAD housing opposite the top surface comprising a bottom surface of the IEAD housing; (g) placing an insulating layer of non-conductive material around the perimeter edge of the IEAD housing; (h) placing a circumscribing electrode over the insulating layer of non-conductive material around the perimeter edge of the IEAD housing, and then electrically connecting the distal end of the feed-through pin to circumscribing electrode; and (i) covering all external surface areas of the IEAD housing with a layer of non-conductive material except for the circumscribing electrode around the perimeter of the IEAD housing and the central electrode centrally located on the bottom surface of the IEAD housing.
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Specification