Implantable electroacupuncture device and method for treating erectile dysfunction

• US 9,078,801 B2
• Filed: 03/04/2013
• Issued: 07/14/2015
• 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, Greiner, Stacy O.
• Primary Examiner(s): Koharski, Christopher D.
• Assistant Examiner(s): So, Elizabeth K
• Application Number:
  US13/784,573
• Publication Number:
  US 20140214112A1
• Time in Patent Office: 862 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2005/418 by electrical stimulation
• CPC Class Codes: A61F 5/41 Devices for promoting penis erection penis implants A61F2/26; massage of the genitals A61H19/00
• CPC Class Codes: A61H 2201/5005 for controlling frequency distribution, modulation or interference of a driving signal
• CPC Class Codes: A61H 2201/5038 freely programmable by the user
• CPC Class Codes: A61H 2201/5097 wireless
• CPC Class Codes: A61H 2205/087 Genitals
• CPC Class Codes: A61H 39/002 Using electric currents electrotherapy A61N1/32
• CPC Class Codes: A61N 1/18 Applying electric currents by contact electrodes
• CPC Class Codes: A61N 1/36107 Sexual dysfunction stimulating genital organs A61N1/36007
• 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 1/375 Constructional arrangements, e.g. casings
• 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: Y10T 29/49002 Electrical device making

Abstract

An implantable electroacupuncture device (IEAD) treats an erectile dysfunction condition of a patient through application of stimulation pulses applied at a target tissue location underlying, or in the vicinity of, at least one of acupoints BL52, BL23 or GV4. The IEAD comprises an implantable, coin-sized, self-contained, leadless electroacupuncture device having at least two electrodes attached to an outside surface of its housing. The device generates stimulation pulses in accordance with a specified stimulation regimen. Power management circuitry within the device allows a primary battery, having a high internal impedance, to be used to power the device. The stimulation regimen generates stimulation pulses during a stimulation session of duration T3 minutes applied every T4 minutes. The duty cycle, or ratio T3/T4, is very low, no greater than 0.05. The low duty cycle and careful power management allow the IEAD to perform its intended function for several years.

Claims

1. A method for treating erectile dysfunction in a patient comprising the steps of:

(a) implanting a thin, self-contained, leadless, coin-sized electroacupuncture (EA) device in the patient below the patient'"'"'s skin at at least one specified stimulation site;

(b) enabling the EA device to generate stimulation sessions at a duty cycle that is less than 0.05, each stimulation session comprising a series of stimulation pulses, wherein the duty cycle is the ratio of T3/T4, where T3 is the time or duration of each stimulation session, and T3 is at least 10 minutes, and T4 is the time between stimulation sessions, and T4 is at least 1440 minutes [1 day] and no more than 20,160 minutes [14 days], thereby applying a stimulation regimen that limits the frequency and duration of the stimulation sessions; and

(c) continuously delivering the stimulation pulses of each stimulation session to the at least one specified stimulation site through at least two concentric electrodes/arrays configured on an outside surface of the thin, self-contained, leadless, coin-sized EA device, wherein the continuous delivery of the stimulation regimen, as limited by requiring the T3/T4 ratio to always be less than 0.05, slowly and methodically remodels the patient'"'"'s central nervous system to produce a sustained therapeutic benefit of the patient'"'"'s erectile dysfunction condition.

2. The method of treating erectile dysfunction of claim 1 wherein the at least one specified stimulation site at which the stimulation pulses are applied comprises tissue underlying, or in the immediate vicinity of, at least one of acupoints BL52, BL23 or GV4.

3. The method of treating erectile dysfunction of claim 2 further comprising configuring the at least two concentric electrodes/arrays on the outside surface of the EA device as one central electrode/array, and as one annular electrode/array that surrounds the central electrode/array, wherein the spacing between the center of the central electrode/array and an edge of the annular electrode/array closest to the central electrode/array comprises at least 5 mm.

4. The method of treating erectile dysfunction of claim 3 further including forming the annular electrode/array as a ring electrode/array attached around a perimeter edge of the coin-sized EA device.

5. The method of treating erectile dysfunction of claim 4 further including configuring the central electrode/array as a cathode electrode and the perimeter-edge ring electrode/array as an anode electrode.

6. The method of treating erectile dysfunction of claim 2 wherein enabling the EA device to generate stimulation sessions includes generating the series of stimulation pulses within each stimulation session so that each stimulation pulse has a duration of between 0.1 and 2.0 milliseconds, occurs at a rate of between 1 and 15 Hz and has a reverse trapezoidal wave shape.

7. The method of treating erectile dysfunction of claim 6 further comprising setting T3, the duration of the stimulation session, to a value between 10 minutes and 30 minutes.