Electrode configuration for an implantable electroacupuncture device

• US 9,066,845 B2
• Filed: 02/25/2013
• Issued: 06/30/2015
• Est. Priority Date: 03/06/2012
• Status: Active Grant

• Current Assignee: Valencia Bioscience, Inc.
• Original Assignee: Valencia Technologies Corporation
• Inventors: Peterson, David K. L., Thenuwara, Chuladatta H.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): So, Elizabeth K
• Application Number:
  US13/776,155
• Publication Number:
  US 20140214144A1
• Time in Patent Office: 855 Days
• Field of Search: None
• 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 1/04 Electrodes electrosurgical electrodes A61B18/14
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• 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 1/3616 Voltage density or current density
• 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

Abstract

An implantable electroacupuncture device (IEAD) treats a disease or medical condition of a patient through application of stimulation pulses applied at a specified acupoint or other target tissue location at a very low duty cycle. In a preferred implementation, the IEAD is an implantable, coin-sized, self-contained, leadless device having at least two electrodes attached to an outside surface of its housing, with at least one electrode on the top or bottom surface of the housing functioning as a cathode, and at least one electrode on the perimeter edge of the housing functioning as an anode. The electrodes may be segmented to include an array of smaller cathodic or anodic electrodes, each of which may be selectively turned ON or OFF so as to provide a convenient mechanism for adjusting the density of the stimulus current flowing through the cathodic electrode surface area.

Claims

1. A self-contained 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, comprising:

a rigid, coin-shaped housing having a thickness of no greater than about 2.5 mm and a diameter no greater than about 25 mm;

at least one cathodic electrode and at least one anodic electrode formed in a prescribed configuration as an integral part of at least one outside surface of the housing;

stimulation circuitry residing inside the housing and electrically coupled to the at least one cathodic and at least one anodic electrodes, wherein the stimulation circuitry generates EA stimulation pulses that are delivered to body tissue through the at least one cathodic and at least one anodic electrodes in accordance with a prescribed stimulation regimen, wherein said stimulation regimen defines 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, wherein 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; and

a coin-cell type primary battery residing inside the housing that provides the operating power for the stimulation circuitry, wherein the primary battery has an internal impedance that is greater than 5 ohms;

wherein the IEAD is leadless and the IEAD housing is hermetically-sealed, and the coin-cell primary battery has sufficient capacity to power the operation of the IEAD in accordance with the prescribed stimulation regimen for at least two years without any further action needed on the part of the patient or other medical personnel; and

wherein the at least one cathodic electrode is located on a top or bottom surface of the housing and positioned no closer than 5 mm from the closest edge of the nearest at least one anodic electrode, wherein at least one of the cathodic or anodic electrodes comprises an annular or circumscribing electrode that surrounds or encompasses the other at least one cathodic or anodic electrodes, and wherein the total surface area of the at least one cathodic electrode is no smaller than about 0.5 mm², and wherein the positioning and surface area of the at least one cathodic electrode is selected to allow a desired current density to flow through the electrode surface area without causing electrode corrosion or current shunting.

2. The IEAD of claim 1, wherein the at least one cathodic electrode comprises a first cathodic electrode located on a top surface of the housing and a second cathodic electrode located on a bottom surface of the housing, and wherein the stimulation circuitry includes switching circuitry that selectively activates (i) only the first cathodic electrode, or (ii) only the second cathodic electrode, or (iii) both the first and second cathodic electrodes when the stimulation pulses are delivered to the body tissue in accordance with the prescribed stimulation regimen.

3. The IEAD of claim 2, wherein the at least one anodic electrode is formed as a ring electrode residing substantially around a perimeter edge of the housing.

4. The IEAD of claim 3, wherein the first and second cathodic electrodes each comprise multiple small cathodic electrodes distributed over the top and bottom surface areas of the housing in accordance with a prescribed pattern.

5. The IEAD of claim 4 wherein the at least one anodic electrode comprises multiple small anodic electrodes distributed around the perimeter edge of the housing.

6. The IEAD of claim 5 wherein the stimulation circuitry includes additional cathodic switching circuitry that selectively activates only a desired grouping of the first and second cathodic electrodes, wherein the location of the body tissue receiving the stimulation pulses may be selected by controlling which groups of electrodes are activated and which are not activated, wherein an activated electrode comprises an electrode that is turned ON by the switching circuitry so that an electrical current may flow through the electrode, and a non-activated electrode comprises an electrode that is turned OFF by the switching circuitry so as to prevent electrical current from flowing through the electrode.

7. The IEAD of claim 1 wherein the housing has a maximum linear dimension no greater than about 25 mm in a first plane orthogonal to a second plane wherein the thickness of the housing is measured, and wherein the at least one cathodic electrode comprises a single cathodic electrode located in the center of a bottom surface of the housing, the bottom surface comprising that surface of the housing adapted to face towards a desired target tissue location whereat EA stimulation pulses are to be applied.

8. The IEAD of claim 1 wherein the single cathodic electrode is segmented into a central electrode and a plurality of concentric ring electrodes surrounding the central electrode.