Implantable electroacupuncture device for reducing hypertension

• US 9,327,109 B2
• Filed: 07/30/2014
• Issued: 05/03/2016
• Est. Priority Date: 08/30/2011
• Status: Active Grant

• Current Assignee: Valencia Bioscience, Inc.
• Original Assignee: Valencia Technologies Corporation
• Inventors: Greiner, Jeffrey H., Peterson, David K. L., Thenuwara, Chuladatta
• Primary Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US14/446,512
• Publication Number:
  US 20150012056A1
• Time in Patent Office: 643 Days
• US Class Current: 1/1
• CPC Class Codes: A61H 2201/5005 for controlling frequency distribution, modulation or interference of a driving signal
• CPC Class Codes: A61H 2201/5035 Several programs selectable
• CPC Class Codes: A61H 2201/5038 freely programmable by the user
• CPC Class Codes: A61H 2201/5097 wireless
• CPC Class Codes: A61H 39/002 Using electric currents electrotherapy A61N1/32
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3758 Packaging of the components within the casing
• CPC Class Codes: A61N 1/3782 producing a voltage above the power source level
• CPC Class Codes: Y10S 128/907 Acupuncture

Abstract

Disclosed is an implantable, coin-sized, self-contained, leadless electroacupuncture (EA) device having at least two electrode contacts attached to the surface of its housing. The electrodes include a central cathode electrode on a bottom side of the housing, and a circumferential anode electrode that surrounds the cathode electrode. In one embodiment, the anode annular electrode is a ring electrode placed around the perimeter edge of the coin-shaped housing. The EA device is adapted to be implanted through a very small incision, e.g., less than about 2-3 cm in length, directly adjacent to a selected acupuncture site known to moderate or affect a hypertension condition of a patient. Appropriate power management circuitry within the device allows a primary battery having a relatively high internal impedance to be used without causing unacceptable dips in battery voltage when the instantaneous battery current surges. Stimulation pulses are generated during a stimulation session that has a duration of T3 minutes and which is applied every T4 minutes. The duty cycle, or ratio of T3 to T4, is very low, not greater than 0.05. This low duty cycle, along with careful power management, allows the EA device to perform its intended function for several years.

Claims

1. An Implantable ElectroAcupuncture Device (IEAD) for treating hypertension through application of electroacupuncture (EA) stimulation pulses applied at a specified acupoint of a patient, wherein the specified acupoint is selected from the group of acupoints that includes:

PC5, PC6, ST36, and ST37, the IEAD comprising;

a small, coin-shaped IEAD housing having an electrode configuration thereon that includes at least two electrodes/arrays, the longest linear dimension of the small, coin-shaped 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 about at the 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 around and at least about 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 into the patient'"'"'s tissue at the specified acupoint, and wherein a second surface of the IEAD housing, on the opposite side of the housing from the first surface, when implanted, is adapted to be closest to the patient'"'"'s skin;

pulse generation circuitry located within the IEAD housing and electrically coupled to the at least two electrodes/arrays, wherein said pulse generation circuitry is adapted to deliver EA stimulation pulses to the patient'"'"'s body tissue at the specified acupoint in accordance with a specified stimulation regimen, 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 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 sensor contained within the IEAD housing responsive to operating commands wirelessly sensed within the IEAD from a non-implanted location, said operating commands allowing the IEAD to be turned ON or OFF, and the amplitude of the stimulation pulses to be adjusted within lower and upper limits, and the values of T3 and T4 to be adjusted within lower and upper limits.

2. The IEAD of claim 1 wherein the central electrode/array comprises an electrode array having no more than 4 segments, the central electrode array having a maximum linear dimension of no greater than about 7 mm.

3. The IEAD of claim 2 wherein the circumferential electrode/array comprises an electrode array having no more than 4 electrode segments positioned around the central electrode/array.

4. The IEAD of claim 3 wherein the circumferential electrode/array comprises an anode electrode/array and the central electrode/array comprises a cathode electrode/array.

5. The IEAD of claim 3 wherein the circumferential electrode/array comprises a cathode electrode/array and the central electrode/array comprises an anode electrode/array.

6. The IEAD of claim 1 wherein the small IEAD housing is coin-shaped having a diameter no greater than about 25 mm and a thickness of no greater than about 2.5 mm.

7. The IEAD of claim 1 wherein the small IEAD housing is oval shaped having a maximum linear dimension of no greater than about 25 mm and a thickness of no greater than about 2.5 mm.

8. The IEAD of claim 1 wherein the duration of the stimulation session T3 varies between 10 minutes and 60 minutes when the rate of occurrence of the stimulation session T4 is set to a value between 1,200 minutes and 20,160 minutes [14 days];

and wherein T3 varies between 10 minutes and a maximum T3 value, T3(max), when T4 is set to a value between 720 minutes and 1,200 minutes, wherein the value of T3(max) varies as a function of T4 as defined by the equation;

T3(max)=0.05*T4.

9. The IEAD of claim 1 wherein the pulse generation circuitry includes:

a boost converter circuit that boosts the nominal voltage of the primary battery to an output voltage V_OUT that is at least three times the nominal battery voltage;

a control circuit that selectively turns the boost converter circuit OFF and ON to limit the amount of current that may be drawn from the primary battery; and

an output circuit powered by V_OUT and controlled by the control circuit that generates the EA stimulation pulses as defined by the specified stimulation regimen.

10. The IEAD of claim 9 wherein the EA stimulation pulses generated by the pulse generation circuit and delivered through the at least two electrodes/arrays into a load at the specified acupoint comprise voltage pulses having a voltage amplitude of no less than about 1 V and no greater than about 15 V.

11. The IEAD of claim 9 wherein the EA stimulation pulses generated by the pulse generation circuit and delivered through the at least two electrodes/arrays into a load at the specified acupoint comprise current pulses having a current amplitude of no less than about 1 milliampere (mA) and no greater than about 15 mA.

12. The IEAD of claim 9 wherein the primary battery has sufficient capacity to power the pulse generation circuitry in accordance with the specified stimulation regimen for a minimum of 2 years.