Implantable Electroacupuncture Device and Method for Treating Erectile Dysfunction

摘要

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.

主权项

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:
a small IEAD housing having an electrode configuration thereon that includes at least two electrodes/arrays, the longest linear dimension of the small 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 inwardly into the patient's tissue at or near the target tissue location, 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 or near the target tissue location 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 communicated to the IEAD from a non-implanted location, said operating commands allowing limited external control of the IEAD.