Implantable electroacupuncture system and method for treating Parkinson's disease and essential tremor

• US 9,433,786 B2
• Filed: 02/12/2013
• Issued: 09/06/2016
• Est. Priority Date: 03/06/2012
• Status: Active Grant

• Current Assignee: Valencia Bioscience, Inc.
• Original Assignee: Valencia Technologies Corporation
• Inventors: Greiner, Jeffrey H., Peterson, David K. L., Thenuwara, Chuladatta, Chambliss, Stacy Greiner
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): Hankins, Lindsey G
• Application Number:
  US13/765,572
• Publication Number:
  US 20140214119A1
• Time in Patent Office: 1,302 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36153 Voltage A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• 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 1/3782 producing a voltage above the power source level

Abstract

An implantable electroacupuncture device (IEAD) treats Parkinson'"'"'s disease or Essential Tremor through application of stimulation pulses applied at at least one of acupoints GB34 and GV20. The IEAD 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.

Claims

1. A method for treating Parkinson'"'"'s disease or Essential Tremor of a patient, comprising the steps of:

(a) implanting a leadless, self-contained, coin-sized electroacupuncture (EA) device in the patient below the patient'"'"'s skin at or near a target tissue location, the EA device comprising a coin-shaped hermetically-sealed housing wherein electrical circuitry and a power source are housed, the electrical circuitry and the power source configured to generate stimulation pulses, the EA device further having a central electrode of a first polarity and positioned in a center of a front surface of the housing and an annular electrode of a second polarity and that surrounds the central electrode on the housing, wherein a spacing between a center of the central electrode and the annular electrode comprises at least 5 mm;

(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 included in the stimulation sessions comprises a series of stimulation pulses,

the duty cycle is a ratio of T3 to T4,

each stimulation session included in the stimulation sessions has a duration of T3 minutes and occurs at a rate of once every T4 minutes, and

T3 is at least 10 minutes; and

(c) delivering the stimulation pulses of each stimulation session included in the stimulation sessions to the target tissue location through the central electrode and the annular electrode, wherein the stimulation sessions are applied to the target tissue location at the duty cycle, and wherein the delivery of the stimulation sessions at the duty cycle causes, over time, a slow and methodical treatment for Parkinson'"'"'s disease or Essential Tremor at the target tissue location that remodels the central nervous system to produce a desired sustained therapeutic effect.

2. The method of treating Parkinson'"'"'s disease or Essential Tremor of claim 1 wherein the target tissue location at which the stimulation pulses are applied is selected from the group of target tissue locations comprising acupoints GV20 or GB34.

3. The method of treating Parkinson'"'"'s disease or Essential Tremor of claim 1 further including setting T4 to be at least 1440 minutes [1 day].

4. The method of claim 1 wherein the coin-shaped housing of the EA device has a diameter no greater than about 25 mm, and a thickness no greater than about 2.5 mm, and wherein the annular electrode comprises a ring electrode formed on a perimeter edge of the coin-shaped housing.

5. A method for treating Parkinson'"'"'s disease or Essential Tremor of a patient, comprising:

(a) packaging electrical circuitry and a coin-cell battery, electrically configured in a circuit relationship that causes electrical stimulation pulses to be generated, within a leadless, hermetically-sealed, coin-sized and coin-shaped housing of an electroacupuncture (EA) device, the EA device having a central electrode of a first polarity and positioned in a center of a front surface of the housing and an annular electrode of a second polarity and that surrounds the central electrode on the housing, wherein a spacing between a center of the central electrode and the annular electrode comprises at least 5 mm;

(b) implanting the EA device in the patient below the patient'"'"'s skin at or near a target tissue location;

(c) 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 included in the stimulation sessions comprises a series of stimulation pulses,

the duty cycle is a ratio of T3 to T4,

each stimulation session included in the stimulation sessions has a duration of T3 minutes and occurs at a rate of once every T4 minutes, and

T3 is at least 10 minutes; and

(d) delivering the stimulation pulses of each stimulation session included in the stimulation sessions to the target tissue location through the central electrode and the annular electrode, wherein the stimulation sessions are applied to the target tissue location at the duty cycle, and wherein the delivery of the stimulation sessions at the duty cycle causes, over time, a slow and methodical treatment for Parkinson'"'"'s disease or Essential Tremor at the target tissue location that remodels the central nervous system so as to create a long term desired therapeutic effect.

6. The method of claim 5 wherein the coin-sized and coin-shaped housing wherein the electrical circuitry and coin-cell battery are packaged has a maximum linear dimension in a first plane no larger than about 25 mm, and a maximum linear dimension in a second plane orthogonal to the first plane of not more than about 2.5 mm.

7. The method of claim 5 wherein the annular electrode is located around a perimeter edge of the coin-sized and coin-shaped case.

8. The method of claim 5 wherein the coin-cell battery packaged within the coin-sized and coin-shaped housing has a nominal output voltage of about 3.0 volts and an internal impedance of no less than about 5 ohms, and further wherein the circuit relationship established between the electrical circuitry and coin-cell battery causes electrical stimulation pulses to be generated by:

(a) boosting the nominal voltage of the coin-cell battery to an output voltage VOUT that is at least three times the nominal battery voltage;

(b) switching the circuitry that boosts the coin-cell battery voltage OFF and ON to limit the amount of current that may be drawn from the coin-cell battery;

(c) generating a series of stimulation pulses having an amplitude A and a width of time T1 by controlling the duration and frequency during which an output current, derived from VOUT, is applied across the central electrode and the annular electrode; and

(d) generating a stimulation session by allowing the series of stimulation pulses to be applied across the electrodes only for a time period T3.

9. The method of claim 5 further including continually applying the stimulation sessions to the target tissue location for a period of time that is at least two years.