Implantable Electroacupuncture System and Method for Treating Dyslipidemia and Obesity
First Claim
1. An Implantable ElectroAcupuncture System (IEAS) for treating obesity or dyslipidemia through application of electroacupuncture (EA) stimulation pulses applied at a specified tissue location of a patient, comprising:
- an implantable electroacupuncture (EA) device comprising a small, hermetically-sealed housing containing a primary power source, pulse generation circuitry powered by the primary power source, and a sensor that wirelessly senses operating commands generated external to the housing, wherein the pulse generation circuitry generates stimulation pulses in accordance with a specified stimulation regimen as controlled at least in part by the operating commands sensed through the sensor;
a plurality of electrode arrays, where an electrode array comprises an array of n conductive contacts electrically joined together to function jointly as one electrode, where n is an integer, on the outside of the EA device housing electrically coupled to the pulse generation circuitry on the inside of the EA device housing through at least one feed-through terminal passing through a wall of the hermetically-sealed housing, whereby the stimulation pulses generated by the pulse generation circuitry are directed to the electrode arrays on the outside of the EA device housing, where the electrical pulses are applied at the specified tissue location through the plurality of electrode arrays in accordance with the specified stimulation regimen;
wherein the specified stimulation regimen defines how often a stimulation session comprising a stream of stimulation pulses is applied to the patient, the stimulation regimen requiring that the stimulation session have a duration of T3 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 the specified tissue location whereat EA stimulation pulses are applied comprises a target tissue location defined by at least one acupoint selected from the group of acupoints comprising ST36, SP4, ST37, ST40, SP6, SP9, K16, LR8, or at least one target tissue location along at least one of their underlying nerves, the saphenous and peroneal nerves.
1 Assignment
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Accused Products
Abstract
An Implantable ElectroAcupuncture System (IEAS) treats dyslipidemia or obesity through application of stimulation pulses applied at at least one of acupoints ST36, SP4, ST37, ST40, SP6, SP9, K16, or LR8, or underlying nerves saphenous or peroneal. The IEAS includes an hermetically-sealed implantable electroacupuncture (EA) device having at least two electrodes located outside of its housing. The housing contains a primary power source, pulse generation circuitry, and a sensor that wirelessly senses externally-generated operating commands. The pulse generation circuitry generates stimulation pulses as controlled, at least in part, by the operating commands sensed through the sensor. The stimulation pulses are applied to the specified acupoint or nerve through the electrodes in accordance with a specified stimulation regimen. Such stimulation regimen requires that the stimulation session be applied at a very low duty cycle not greater than 0.05.
32 Citations
36 Claims
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1. An Implantable ElectroAcupuncture System (IEAS) for treating obesity or dyslipidemia through application of electroacupuncture (EA) stimulation pulses applied at a specified tissue location of a patient, comprising:
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an implantable electroacupuncture (EA) device comprising a small, hermetically-sealed housing containing a primary power source, pulse generation circuitry powered by the primary power source, and a sensor that wirelessly senses operating commands generated external to the housing, wherein the pulse generation circuitry generates stimulation pulses in accordance with a specified stimulation regimen as controlled at least in part by the operating commands sensed through the sensor; a plurality of electrode arrays, where an electrode array comprises an array of n conductive contacts electrically joined together to function jointly as one electrode, where n is an integer, on the outside of the EA device housing electrically coupled to the pulse generation circuitry on the inside of the EA device housing through at least one feed-through terminal passing through a wall of the hermetically-sealed housing, whereby the stimulation pulses generated by the pulse generation circuitry are directed to the electrode arrays on the outside of the EA device housing, where the electrical pulses are applied at the specified tissue location through the plurality of electrode arrays in accordance with the specified stimulation regimen; wherein the specified stimulation regimen defines how often a stimulation session comprising a stream of stimulation pulses is applied to the patient, the stimulation regimen requiring that the stimulation session have a duration of T3 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 the specified tissue location whereat EA stimulation pulses are applied comprises a target tissue location defined by at least one acupoint selected from the group of acupoints comprising ST36, SP4, ST37, ST40, SP6, SP9, K16, LR8, or at least one target tissue location along at least one of their underlying nerves, the saphenous and peroneal nerves. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. An Implantable ElectroAcupuncture System (IEAS) for treating obesity and dyslipidemia conditions of a patient, comprising
a) an implantable electroacupuncture (EA) device housing having a maximum linear dimension of no more than 25 mm in a first plane, and a maximum height of no more than 2.5 mm in a second plane orthogonal to the first plane; -
b) a primary battery within the EA housing having an internal impedance of no less than about 5 ohms; c) pulse generation circuitry within the EA housing and powered by the primary battery that generates stimulation pulses during a stimulation session; d) control circuitry within the EA housing and powered by the primary battery that controls the frequency of the stimulation sessions to occur no more than once every T4 minutes, and that further controls the duration of each stimulation session to last no longer than T3 minutes, where the ratio of T3/T4 is no greater than 0.05; e) sensor circuitry within the EA housing and coupled to the control circuitry that is responsive to the presence of a control command generated external to the EA device housing, which control command when received by the control circuitry sets the times T3 and T4 to appropriate values; and f) a plurality of electrodes located outside of the EA device housing that are electrically coupled to the pulse generation circuitry within the EA device housing, wherein stimulation pulses of the stimulation sessions are applied to body tissue located in the vicinity of the plurality of electrodes; and g) wherein the plurality of electrodes are positioned to lie at or near a target tissue location belonging to the group of target tissue locations comprising acupoints ST36, SP4, ST37, ST40, SP6, SP9, K16, and LR8, or at least one target tissue location along at least one of their underlying nerves, the saphenous and peroneal nerves. - View Dependent Claims (16)
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17. A method for treating obesity or dyslipidemia of a patient, comprising the steps of:
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(a) implanting an electroacupuncture (EA) device in the patient below the patient'"'"'s skin at or near at least one specified target tissue location; (b) enabling the EA device to generate stimulation sessions at a duty cycle that is less than or equal to 0.05, wherein each stimulation session comprises a series of stimulation pulses, wherein the duty cycle is the ratio of T3/T4, where T3 is the duration of each stimulation session, and T4 is the duration between stimulation sessions; and (c) delivering the stimulation pulses of each stimulation session to the at least one specified target tissue location through a plurality of electrode arrays electrically connected to the EA device, where an electrode array comprises an array of n conductive contacts electrically joined together to function jointly as one electrode, where n is an integer. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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28. A method of treating obesity or dyslipidemia of a patient using a small implantable electroacupuncture device (IEAD) powered by a small disc primary battery having a specified nominal output voltage of about 3 volts, and having an internal impedance of at least 5 ohms, the IEAD being configured, using electronic circuitry within the IEAD, to generate stimulation pulses in accordance with a specified stimulation regimen and apply the stimulation pulses through at least two electrodes located outside of the housing of the IEAD at a selected tissue location, said at least two electrodes comprising at least one cathode electrode and at least one anode electrode, said method comprising:
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(a) implanting the IEAD below the skin surface of the patient at or near a target tissue location selected from the group of target tissue locations comprising acupoints ST36, SP4, ST37, ST40, SP6, SP9, K16, LR8 and their underlying nerves, the saphenous nerve and the peroneal nerve, and (b) enabling the IEAD to provide EA stimulation pulses in accordance with a stimulation regimen that provides a stimulation session having a duration of T3 minutes at a rate of once every T4 minutes, where the ratio of T3/T4 is no greater than 0.05, and wherein T3 is at least 10 minutes and no greater than 60 minutes. - View Dependent Claims (29, 30, 31, 32)
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33. A method of assembling an implantable electroacupuncture device (IEAD) in a small, thin, hermetically-sealed, housing having a maximum linear dimension in a first plane of no more than 25 mm and a maximum linear dimension in a second plane orthogonal to the first plane of no more than 2.5 mm, the housing having at least one feed-through pin assembly radially passing through a wall of the thin housing that isolates the feed-through pin assembly from high temperatures and residual weld stresses that occur when the thin housing is welded shut to hermetically-seal its contents, the IEAD being adapted for use in treating obesity and dyslipidemia of a patient, the method comprising the steps of:
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(a) forming a thin 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 maximum linear dimension of no more than 25 mm; (b) forming a recess in a wall of the housing; (c) placing a feed-through assembly within the recess so that a feed-through pin of the feed-through assembly electrically passes through a wall of the recess at a location that is separated from where the wall of the housing is designed to contact the top cover plate; and (d) welding the top cover plate to the bottom case around a perimeter of the bottom case, thereby hermetically sealing the bottom case and top case together.
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34. An Implantable ElectroAcupuncture System (IEAS) for treating obesity or dyslipidemia of a patient;
- the IEAS comprising (a) at least one external component, and (b) a small, thin implantable component having a maximum linear dimension in a first plane of less than about 25 mm, and a maximum linear dimension in a second plane orthogonal to the first plan of no more than about 2.5 mm;
wherein the at least one external component comprises an electromagnetic field generator; and
wherein the small, thin implantable component comprises;a housing made of a bottom part and a top part that are welded together to create an hermetically-sealed, closed container, at least one feed-through terminal that passes through a portion of a wall of the top part or bottom part, and which allows electrical connection to be made between the inside of the closed container and a location on the outside of the closed container, electronic circuitry inside of the closed container that, when enabled, generates stimulation pulses during a stimulation session, the stimulation session having a duration of T3 minutes, and wherein the electronic circuitry generates a new stimulation session at a rate of once every T4 minutes, where the ratio of T3/T4 is no greater than 0.05, wherein the stimulation pulses are coupled to the at least one feed-through terminal, a sensor on the inside of the closed container adapted to sense the presence or absence of an electromagnetic field, a power source inside of the closed container that provides operating power for the electronic circuitry, and a plurality of electrodes/arrays located on an outside surface of the closed housing, at least one of which is electrically connected to the at least one feed-through terminal, whereby the stimulation pulses contained in the stimulation sessions are made available to stimulate body tissue in contact with or near the plurality of electrodes on the outside of the closed housing; and wherein the at least one external component modulates an electromagnetic field which, when sensed by the sensor inside of the closed container, conveys information to the electronic circuitry inside of the closed housing that controls when and how long the stimulation sessions are applied through the plurality of electrodes/arrays. - View Dependent Claims (35, 36)
- the IEAS comprising (a) at least one external component, and (b) a small, thin implantable component having a maximum linear dimension in a first plane of less than about 25 mm, and a maximum linear dimension in a second plane orthogonal to the first plan of no more than about 2.5 mm;
Specification