| 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. An Implantable ElectroAcupuncture Device (IEAD) for treating hypertension through application of electroacupuncture (EA) stimulation pulses applied substantially at a specified acupoint of a patient, wherein the specified acupoint is selected from the group of acupoints that includes: PC5, PC6, ST36, and ST37, the IEAD comprising:
a small, coin-shaped IEAD housing having an electrode configuration thereon that includes at least two electrodes/arrays, the longest linear dimension of the small, coin-shaped IEAD housing being no greater than about 25 mm, wherein at least one of said at least two electrodes/arrays comprises a central electrode/array located substantially in the center of a first surface of the IEAD housing, and wherein at least another of said at least two electrodes/arrays comprises a circumferential electrode/array located substantially around and at least 5 mm distant from the center of the central electrode/array, wherein the first surface of the IEAD housing when implanted is adapted to face into the patient's tissue at the specified acupoint, and wherein a second surface of the IEAD housing, on the opposite side of the housing from the first surface, when implanted, is adapted to be closest to the patient's skin; pulse generation circuitry located within the IEAD housing and electrically coupled to the at least two electrodes/arrays, wherein said pulse generation circuitry is adapted to deliver EA stimulation pulses to the patient's body tissue at the specified acupoint in accordance with a specified stimulation regimen, said stimulation regimen defining the duration and rate at which a stimulation session is applied to the patient, said stimulation regimen requiring that the stimulation session have a duration of T3 minutes and a rate of occurrence of once every T4 minutes, wherein the ratio of T3/T4 is no greater than 0.05, and wherein during each stimulation session EA stimulation pulses having one or more specified widths and amplitudes are generated at one or more specified rates; a primary battery contained within the IEAD housing and electrically coupled to the pulse generation circuitry, said primary battery having a nominal output voltage of 3 volts, and an internal impedance greater than 5 ohms; and a sensor contained within the IEAD housing responsive to operating commands wirelessly sensed within the IEAD from a non-implanted location, said operating commands allowing the IEAD to be turned ON or OFF, and the amplitude of the stimulation pulses to be adjusted within lower and upper limits, and the values of T3 and T4 to be adjusted within lower and upper limits. |
