Surgery – Means for introducing or removing material from body for... – Infrared – visible light – ultraviolet – x-ray or electrical...
Reexamination Certificate
1998-02-25
2001-02-06
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Infrared, visible light, ultraviolet, x-ray or electrical...
C607S060000
Reexamination Certificate
active
06185452
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to devices configured for implanting beneath a patient's skin and more particularly to such devices incorporating a battery for powering electronic circuitry for various purposes including tissue, e.g., nerve or muscle, stimulation and/or parameter monitoring and/or data communication.
Implantable devices for tissue stimulation (i.e., microstimulators) are known in the art. See, e.g., U.S. Pat. Nos. 5,193,539; 5,193,540; 5,312,439; 5,324,316; 5,358,514; 5,405,367; 5,571,148, which are incorporated herein by reference.
Such known microstimulators are characterized by a sealed housing which contains electronic circuitry for producing small electric currents between spaced electrodes. By precisely implanting the microstimulators proximate to targeted tissue, the currents will stimulate the nerve to produce medically beneficial results.
Typically, such prior microstimulators derive operating power from an internal coil that is inductively coupled to an external AC magnetic field produced, for example, by a drive coil mounted proximate to the microstimulator. An AC voltage induced in the internal coil is rectified and filtered to produce a DC operating voltage which is used to power the electronic circuitry. Such an arrangement requires that the user remain in close proximity to the drive coil to maintain tissue stimulation.
SUMMARY OF THE INVENTION
The present invention is directed to a device configured for implanting beneath a patient's skin for the purpose of tissue, e.g., nerve or muscle, stimulation and/or parameter monitoring and/or data communication. Devices in accordance with the invention are comprised of a sealed housing, preferably having an axial dimension of less than 60 mm and a lateral dimension of less than 6 mm, containing a self-contained power source capable of supplying at least 1 microwatt-hour to power consuming circuitry for actuating an input/output transducer. The circuitry in each device is preferably remotely addressable and includes a data signal receiver and a device controller.
Depending upon the intended application of the device, the power consuming circuitry can be designed to demand a high load current for a relatively short interval, e.g., for bladder stimulation, or a lower load current for a much longer interval or continuously, e.g., for bone growth stimulation. In accordance with the invention, a power source in accordance with the invention has a capacity of at least 1 microwatt-hour which for a typical application is able to power the circuitry for over one hour, thus liberating the user from having to be continuously coupled to an external field generator.
In accordance with a significant aspect of the invention, the power source comprises a battery, preferably formed by a pair of conductive plates having electrolyte disposed therebetween. The battery is preferably physically configured to minimize eddy current formation.
In accordance with a preferred embodiment of the invention, a charging circuit is provided for recharging the battery. The charging circuit is capable of producing a charging current in response to an externally produced AC magnetic field.
In a further aspect of the present invention, an external charger is used to periodically generate an AC magnetic field for supplying energy to the aforementioned charging circuit and one preferred embodiment includes means for generating a data signal representative of the status of the battery to the external charger.
In accordance with a still further aspect of the invention, an identification address is stored in each implantable device used in a system, thus enabling individual device, to be addressed. That is, the data signal receiver in each device will respond to a data signal identifying the address stored by that device to actuate the device input/output transducer.
The input/output transducer in accordance with the invention preferably comprises at least one electrode. When used for nerve stimulation, the controller supplies a sequence of drive pulses to the electrode to stimulate adjacent nerves. When used for parameter monitoring, the electrode is used to monitor an electrical signal indicative of certain body conditions.
In accordance with a significant feature of preferred embodiments of the invention, each implantable device can be individually addressed and programmed to selectively operate in one or more of the following modes: (1) stimulation, (2) monitoring, and/or (3) communication.
The novel features of the invention are set forth with particularity in the appended claims. The invention will be best understood from the following description when read in conjunction with the accompanying drawings.
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Dell Robert Dan
Gord John C.
Schulman Joseph H.
Freilich Hornbaker & Rosen
Kennedy Sharon
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