Circuits and methods for using a high impedance, thin, coin-cell type battery in an implantable electroacupuncture device

• US 9,827,428 B2
• Filed: 07/21/2015
• Issued: 11/28/2017
• Est. Priority Date: 03/12/2012
• Status: Active Grant

• Current Assignee: Valencia Bioscience, Inc.
• Original Assignee: Valencia Technologies Corporation
• Inventors: Peterson, David K. L., Greiner, Jeffrey H.
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): PHAM, MINH DUC GIA
• Application Number:
  US14/805,336
• Publication Number:
  US 20150321014A1
• Time in Patent Office: 861 Days
• Field of Search: 607 59
• 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 1/36117 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 1/378 Electrical supply
• CPC Class Codes: A61N 1/3782 producing a voltage above the power source level

Abstract

An implantable electroacupuncture device (IEAD) treats a specified medical condition of a patient through application of electroacupuncture (EA) stimulation pulses applied substantially at or near a specified acupoint, its underlying nerves, or other target tissue location. The IEAD includes an IEAD housing having an electrode configuration thereon that includes at least two electrodes, and pulse generation circuitry located within the IEAD housing and electrically coupled to the at least two electrodes. The pulse generation circuitry is adapted to deliver stimulation pulses to the patient'"'"'s body tissue at or near the target tissue location in accordance with a specified stimulation regimen, the stimulation regimen requiring that the stimulation session have a duration of T3 minutes and a rate of occurrence of once every T4 minutes, and wherein a ratio of T3/T4 is no greater than 0.05.

Claims

1. An Implantable ElectroAcupuncture Device (IEAD) for treating a specified medical condition of a patient through application of electroacupuncture (EA) stimulation pulses applied substantially at or near a specified acupoint, its underlying nerves, or other target tissue location, comprising:

an IEAD housing having an electrode configuration thereon that includes at least two electrodes, wherein at least one of the at least two electrodes comprises a central electrode located substantially in the center of a first surface of the IEAD housing, and wherein at least another of the at least two electrodes comprises a circumferential electrode located substantially around and at least 5 mm distant from the center of the central electrode, wherein the first surface of the IEAD housing when implanted is adapted to face inwardly into the patient'"'"'s tissue at or near the specified target tissue location;

pulse generation circuitry located within the IEAD housing and electrically coupled to the at least two electrodes, wherein the pulse generation circuitry is adapted to deliver stimulation pulses to the patient'"'"'s body tissue at or near the target tissue location in accordance with a specified stimulation regimen, the stimulation regimen defining the duration and rate at which a stimulation session 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

a primary battery contained within the IEAD housing and electrically coupled to the pulse generation circuitry, the primary battery having an internal impedance greater than 5 ohms and a capacity of less than 60 mAh, wherein the primary battery is the only battery that provides power to the pulse generation circuitry.

2. The IEAD of claim 1, wherein the circumferential electrode comprises an anode electrode and the central electrode comprises a cathode electrode.

3. The IEAD of claim 1, wherein the circumferential electrode comprises a cathode electrode and the central electrode comprises an anode electrode.

4. The IEAD of claim 1, wherein the 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.

5. The IEAD of claim 1, wherein the primary battery has a nominal output voltage of 3 volts.

6. The IEAD of claim 5, wherein the pulse generation circuitry includes:

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

means for selectively turning 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 VOUT that generates the stimulation pulses as defined by the specified stimulation regimen.

7. The IEAD of claim 6, wherein the stimulation pulses generated by the pulse generation circuit and delivered through the at least two electrodes into a load at the target tissue location comprise current pulses having a current amplitude of no less than about 1 milliampere (mA) and no greater than about 26 mA.

8. The IEAD of claim 1, 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.

9. The IEAD of claim 6, wherein the means for selectively turning the boost converter circuit OFF and ON comprises a boost converter circuit having a shut down feature which automatically places the boost converter circuit in an OFF state whenever a battery voltage of the primary battery falls below a set minimum value, wherein the set minimum value of the primary battery below which the boost converter is placed in an OFF state comprises a voltage that is sufficiently high to continue to power other digital processing circuits within the pulse generation circuitry even when the boost converter is turned OFF.

10. The IEAD of claim 6, wherein the pulse generation circuitry further includes means for reducing leading edge transient signals that may be present in the stimulation pulses generated by the pulse generation circuitry.

11. The IEAD of claim 10, wherein the output circuit of the pulse generation circuitry includes a programmable current source, and wherein the means for reducing leading edge transient signals comprises connecting a cascode circuit at the input of the programmable current source.

12. The IEAD of claim 11, wherein the pulse generation circuitry further includes means for kick starting the programmable current source when low amplitude stimulation pulses are generated, wherein such kick starting eliminates or reduces undesired delays in the leading edge of the stimulation pulses generated by the pulse generation circuitry.

13. The IEAD of claim 1, wherein the electronic circuitry includes power management circuitry that limits an amount of instantaneous current that can be drawn from the primary battery.

14. The IEAD of claim 1, further comprising a sensor contained within the IEAD housing responsive to operating commands wirelessly communicated to the IEAD from a non-implanted location, the operating commands allowing limited external control of the IEAD.

15. The IEAD of claim 1, wherein a second surface of the IEAD housing, on an opposite side of the IEAD housing from the first surface, when implanted, is adapted to be closest to the patient'"'"'s skin.

16. The IEAD of claim 1, wherein the circumferential electrode comprises a ring electrode attached around a perimeter edge of the IEAD housing.

17. The IEAD of claim 1, wherein the IAED housing has a linear dimension in a first plane no greater than about 25 mm, and a linear dimension in a second plane orthogonal to the first plane no greater than about 2.5 mm.

18. The IEAD of claim 1, wherein, during each stimulation session, stimulation pulses having a specified width and a specified amplitude are generated at a specified rate.

19. The IEAD of claim 6, wherein the means for selectively turning the boost converter circuit OFF and ON comprises a control circuit configured to generate a digital signal that modulates the boost converter circuit between an OFF state and an ON state, with the ON state comprising no more than about 2% of the time that the IEAD is operating.