Method for reducing hypertension using an implantable electroacupuncture device

• US 9,358,382 B2
• Filed: 07/30/2014
• Issued: 06/07/2016
• Est. Priority Date: 08/30/2011
• Status: Active Grant

• Current Assignee: Valencia Bioscience, Inc.
• Original Assignee: Valencia Technologies Corporation
• Inventors: Greiner, Jeffrey H., Peterson, David K. L., Thenuwara, Chuladatta
• Primary Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US14/446,500
• Publication Number:
  US 20150012055A1
• Time in Patent Office: 678 Days
• 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 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• 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 1/3782 producing a voltage above the power source level
• CPC Class Codes: Y10S 128/907 Acupuncture

Abstract

Disclosed is an implantable, coin-sized, self-contained, leadless electroacupuncture (EA) device having at least two electrode contacts attached to the surface of its housing. The electrodes include a central cathode electrode on a bottom side of the housing, and a circumferential anode electrode that surrounds the cathode electrode. In one embodiment, the anode annular electrode is a ring electrode placed around the perimeter edge of the coin-shaped housing. The EA device is adapted to be implanted through a very small incision, e.g., less than about 2-3 cm in length, directly adjacent to a selected acupuncture site known to moderate or affect a hypertension condition of a patient. Appropriate power management circuitry within the device allows a primary battery having a relatively high internal impedance to be used without causing unacceptable dips in battery voltage when the instantaneous battery current surges. Stimulation pulses are generated during a stimulation session that has a duration of T3 minutes and which is applied every T4 minutes. The duty cycle, or ratio of T3 to T4, is very low, not greater than 0.05. This low duty cycle, along with careful power management, allows the EA device to perform its intended function for several years.

Claims

1. A method of treating hypertension in a patient using a small, leadless, implantable electroacupuncture device (IEAD) powered by a small disc primary battery having a specified nominal output voltage of 3 volts, and having an internal impedance of at least 5 ohms, the IEAD being configured, using electronic circuitry within the IEAD, to generate EA stimulation pulses in accordance with a specified stimulation regimen and apply the EA stimulation pulses through at least two electrodes/arrays located on the housing of the IEAD to the patient'"'"'s body tissue at a selected tissue location, said at least two electrodes/arrays comprising at least one central electrode/array of a first polarity, having a maximum width of no more 7 mm, centrally located on a first surface of the small IEAD housing, and at least one annular electrode/array of a second polarity spaced apart from the central electrode/array by at least 5 mm measured from the edge of the annular electrode/array closest to the central electrode/array to the center of the central electrode/array, said method comprising:

(a) implanting the IEAD below the skin surface of the patient at one or more acupoints selected from the group of acupoints comprising PC5, PC6, ST36 and ST37, with the first surface of the IEAD facing inwardly into the patient'"'"'s body tissue at the selected acupoint;

(b) enabling the IEAD to provide stimulation pulses in accordance with a stimulation regimen that provides a stimulation session at a rate of once every T4 minutes, with each stimulation session having a duration of T3 minutes, where the ratio of T3/T4 is no greater than 0.05.

2. The method of claim 1 further including setting the time T4 to be at least 720 minutes, but no more than about 20,160 minutes.

3. The method of claim 2 further including setting T3, the duration of the stimulation session, to a value between 10 minutes and 60 minutes if T4, the rate of occurrence of the stimulation session, is set to a value between 1,200 minutes and 20,160 minutes;

and setting T3 to a value between 10 minutes and a maximum T3 value, T3(max), if T4 is set to a value between 720 minutes and 1,200 minutes, wherein T3(max) varies as a function of T4 as defined by the equation;

T3(max)=0.05*T4.

4. The method of claim 1 further including setting the stimulation pulses during a stimulation session to have a duration of T1 seconds, that occur at a rate of once every T2 seconds, where the ratio of T1/T2 is no greater than 0.01.

5. The method of claim 4 further including setting the time T1 to be 0.1 to 1.0 millisecond and the time T2 to be 250 to 1000 milliseconds.

6. The method of claim 1 further including controlling the electronic circuits within the IEAD to limit instantaneous current drawn from the small disc primary battery so that the output voltage of the primary battery does not drop more than about 11% below the output voltage of the primary battery when current is being drawn from the primary battery, where the output voltage of the primary battery is equal to the specified nominal output voltage of the primary battery less the voltage drop caused by the instantaneous current flowing through the internal impedance of the primary battery.

7. The method of claim 6 wherein the electronic circuitry within the IEAD includes a boost converter circuit, and wherein the method of controlling the electronic circuits within the IEAD to limit the instantaneous current drawn from the battery comprises modulating the operation of the boost converter circuit between an ON state and an OFF state.