Implantable Electroacupuncture Device and Method

Abstract

An electroacupuncture device includes 1) a housing configured to be implanted beneath a skin surface of the patient at an acupoint within the patient, 2) a central electrode centrally located on a first surface of the housing, 3) an annular electrode that surrounds the central electrode on the first surface of the housing, the annular electrode being spaced apart from the central electrode, and 4) pulse generation circuitry located within the housing, wherein the pulse generation circuitry generates stimulation sessions at a duty cycle that is less than 0.05 and applies the stimulation sessions at the acupoint by way of the central electrode and the annular electrode in accordance with the duty cycle.

Description

RELATED APPLICATIONS[0001]The present application is a continuation application of U.S. patent application Ser. No. 13 / 796,314, filed Mar. 12, 2013, which application is a continuation-in-part (CIP) application of U.S. application Ser. No. 13 / 598,582, filed Aug. 29, 2012; U.S. patent application Ser. No. 13 / 622,653, filed Sep. 19, 2012; and U.S. patent application Ser. No. 13 / 630,522, filed Sep. 28, 2012. U.S. application Ser. No. 13 / 796,314 also claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 61 / 609,875, filed Mar. 12, 2012; U.S. Provisional Patent Application No. 61 / 672,257, filed Jul. 16, 2012; U.S. Provisional Patent Application No. 61 / 672,661, filed Jul. 17, 2012; U.S. Provisional Patent Application No. 61 / 673,254, filed Jul. 19, 2012; U.S. Provisional Patent Application No. 61 / 674,691, filed Jul. 23, 2012; and U.S. Provisional Patent Application No. 61 / 676,275, filed Jul. 26, 2012. All of these applications are incorporated herein by referenc...

AI Technical Summary

Benefits of technology

[0020]The invention herein described may also be characterized as a method for operating an implantable electroacupuncture device (IEAD) powered only by a thin, coin-cell type battery having an internal impedance greater than 5 ohms, over a period of at least 2 years, during which time the IEAD is adapted to generate stimulus pulses during a stimulation session in accordance with a prescribed stimulation regimen. Such method includes the steps of: (a) powering pulse generation circuitry within the IEAD with the coin-cell type battery; (b) limiting the the duration of stimulation sessions during which stimulus pulses are generated to a time period that has a duty cycle of less than 0.05, where the duty cycle is the ratio of T3 to T4, where T3 is the duration of the stimulation session, and where T4 is the time interval between stimulation sessions; (c) boosting the battery voltage from the coin-cell type battery using a boost converter circuit by a factor of at least 4 in order to provide sufficient operating power to generate current stimulus pulses of up to 25 mA during a stimulation session; and (d) limiting the instantaneous current that can be drawn from the coin-cell type battery to prevent the battery voltage, VBAT, from dropping below safe operating levels.

Problems solved by technology

Further, payment for acupuncture services consumes a not insignificant portion of healthcare expenditures in the U.S. and Europe.

There is general agreement that acupuncture is safe when administered by well-trained practitioners using sterile needles, but not on its efficacy as a medical procedure.

The problem lies in trying to ascertain what is fact from what is fiction.

This problem is made more difficult when conducting research on this topic because the insertion of needles, and the manipulation of the needles once inserted, is more of an art than a science, and results from such research become highly subjective.

The use of an outside coil, complex electronics, and the tubular shape of the microstimulator have all limited the commercial feasibility of the microstimulator device and applications described in the Whitehurst patents.

The methods and devices disclosed in these patents, however, typically utilize (i) large implantable stimulators having long leads that must be tunneled through tissue over an extended distance to reach the desired stimulation site, (ii) external devices that must interface with implanted electrodes via percutaneous leads or wires passing through the skin, or (iii) inefficient and power-consuming wireless transmission schemes.

Such devices and methods are still far too invasive, or are ineffective, and thus are subject to the same limitations and concerns, as are the previously described electrical stimulation devices.

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