Implantable electroacupuncture device and method for treating erectile dysfunction

• US 9,827,134 B2
• Filed: 07/14/2015
• Issued: 11/28/2017
• 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): Carey, Michael
• Assistant Examiner(s): So, Elizabeth K
• Application Number:
  US14/799,492
• Publication Number:
  US 20150313750A1
• Time in Patent Office: 868 Days
• 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 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 EA 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 an erectile dysfunction condition of a patient through application of electroacupuncture (EA) stimulation pulses applied at a target tissue location that is substantially at or near at least one of acupoints BL52, BL23 or GV4, 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 a 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 a 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 target tissue location, and 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;

a memory located within the IEAD housing and that stores a set of parameters that defines a stimulation regimen configured to treat the erectile dysfunction condition; and

pulse generation circuitry located within the IEAD housing and electrically coupled to the at least two electrodes, wherein the pulse generation circuitry delivers EA stimulation pulses configured to treat the erectile dysfunction condition to the patient'"'"'s body tissue at or near the target tissue location in accordance with the stimulation regimen defined by the set of parameters stored in the memory, the stimulation regimen defining a duration and a rate at which a stimulation session is applied to the patient to treat the erectile dysfunction condition, 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.

2. The IEAD of claim 1, wherein the central electrode 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 comprises an electrode array having no more than 4 electrode segments positioned around the central electrode.

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

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

6. 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.

7. The IEAD of claim 1, wherein the 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 is between 20 minutes and 60 minutes and the rate of occurrence of the stimulation session is between 1,440 minutes (1 day) and 10,080 minutes (1 week).

9. The IEAD of claim 1, further comprising a primary battery contained within the IEAD housing and electrically coupled to the pulse generation circuitry, the primary battery having a nominal output voltage of 3 volts, and an internal impedance greater than 5 ohms and no more than 160 ohms.

10. The IEAD of claim 9, 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;

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 VOUT and controlled by the control circuit that generates the EA stimulation pulses as defined by the specified stimulation regimen.

11. The IEAD of claim 10, wherein the EA stimulation pulses generated by the pulse generation circuit and delivered through the at least two electrodes into a load at the specified target tissue location comprise voltage pulses having a voltage amplitude of no less than about 1 V and no greater than about 20 V.

12. The IEAD of claim 10, wherein the EA stimulation pulses generated by the pulse generation circuit and delivered through the at least two electrodes into a load at the specified acupoint comprise current pulses having an average current amplitude of no less than about 1 milliampere (mA) and no greater than about 25 mA.

13. The IEAD of claim 12, wherein the current pulses have a current value that increases during the duration of the current pulse.

14. The IEAD of claim 13, wherein the current pulses increase at least 1 mA during the duration of the current pulse.

15. 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.

16. 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.

17. The IEAD of claim 1, wherein a longest linear dimension of the IEAD housing is no greater than about 25 mm.

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

19. The IEAD of claim 1, wherein the circumferential electrode forms a complete ring that surrounds the central electrode.