Method For Reducing Hypertension Using An Implantable Electroacupuncture Device

摘要

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.

主权项

1. A method of treating hypertension in a patient using a leadless electrode configuration integrated into a self-contained, implantable coin-sized electroacupuncture (EA) device, the EA device having a longest linear dimension D2 no greater than 25 mm, and a thickness W2 no greater than 2.5 mm, wherein the thickness W2 is measured in a plane orthogonal to the longest dimension D2, and wherein the ratio of W2 to D2 is no greater than about 0.13, the method comprising:
(a) making a short incision no longer than about 25 mm in a limb of the patient near at least one of acupoints PC5, PC6, ST36 or ST37; (b) forming a tissue pocket under the skin adjacent the incision; (c) implanting the thin EA device in the patient by sliding the thin edge of the EA device through the incision into the formed pocket; (d) closing the incision; (e) allowing the closed incision to heal; (f) 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 duration in minutes of each stimulation session, and T4 is the time in minutes between stimulation sessions; and (g) delivering the stimulation pulses of each stimulation session through the electrode configuration integrated into the leadless EA device to body tissue of the patient in the vicinity of at least one the acupoints PC5, PC6, ST36 or ST37.