Alfred E. Mann Foundation for Scientific Research

Alfred E. Mann Foundation

Primoz Strojnik

Joseph H Schulman

John Charles Gord

David I Whitmoyer

James H Wolfe

Gerald E Loeb

Paul Meadows

A cochlea stimulation system includes a patient wearable system comprising an externally wearable signal processor (WP) and a headpiece in electronic communication with an implanted cochlear stimulator (ICS). The ICS comprises eight output stages each having two electrically isolated capacitor-coupled electrodes, designated 'A' and 'B', circuits for monitoring the voltages on these electrodes, and circuits for both transmitting status information to and receiving control information from the WP. Based upon information received from the WP, a processor within the ICS can control both the frequency and the widths of the output stimulation pulses applied to the electrodes and may select which electrodes to monitor. The ICS receives power and data signals telemetrically through the skin from the WP. To save power, the ICS may be 'powered down' by the WP based upon the absence of audio information or 'powered up' if audio is present. The WP communicates with the headpiece over a co-axial cable using one frequency for transmitting signals and a second different frequency for receiving signals.

Multichannel implantable cochlear stimulator

An apparatus for hermetically sealing implantable devices, such as a microstimulator, moicrotransducer, microtelemeter, or the like, prevents entrapment of water vapors and other volatile gases, and allows hermeticity testing at all manufacturing levels. The venting of water vapors and other volatile gases is accomplished with a tubular feedthrough that allows such gases trapped within the sealed device to vent during the manufacturing process. The tubular feedthrough also establishes a conduit through which leakage tests or other hermeticity tests can be conducted prior to and after sealing the feedthrough. The tubular feedthrough, when made from conductive materials, also provides for electrical connections between electronic circuits sealed within the device and electrodes and other electrical terminals on the outside of the capsule.

Tubular feedthrough system for hermetically sealed devices

An implantable cochlear stimulator (ICS) has eight output stages (212), each having a current source (212B) connected to a pair of electrodes, designated 'A' and 'B', through respective output coupling capacitors and an electrode switching matrix (212C). An indifferent electrode is connected to each output stage by way of an indifferent electrode switch (212D). The current source generates a precise stimulation current as a function of an analog control voltage. The analog control voltage, in turn, is generated by a logarithmic D/A converter. The D/A converter serially converts data words, received in a data frame from an external source, to respective analog control voltages that are applied sequentially to the current sources of each output stage. An output mode register (208) controls the switching matrix of each stage, as well as the indifferent electrode switch, to configure the electrodes for a desired stimulation configuration, e.g., bipolar stimulation (current flow between the pair of electrodes of the output stage), or monopolar stimulation (current flow between one of the electrodes of the output stage and the indifferent electrode). The voltage at the 'A' and 'B' electrode of each output stage may be selectively telemetered to the wearable system, as may the current flow through the indifferent electrode, thereby facilitating a measurement of the electrode impedance. The 'A' and 'B' electrodes of each output stage may be selectively shorted through a high or low resistance in order to discharge the output coupling capacitors.

A method and apparatus for hermetically sealing implantable devices, such as a microstimulator, moicrotransducer, microtelemeter, or the like, prevents entrapment of water vapors and other volatile gases, and allows hermeticity testing at all manufacturing levels. The venting of water vapors and other volatile gases is accomplished with a tubular feedthrough that allows such gases trapped within the sealed device to vent during the manufacturing process. The tubular feedthrough also establishes a conduit through which leakage tests or other hermeticity tests can be conducted prior to and after sealing the feedthrough. The tubular feedthrough, when made from conductive materials, also provides for electrical connections between electronic circuits sealed within the device and electrodes and other electrical terminals on the outside of the capsule.

Method of forming a tubular feed-through hermetic seal for an

A physician's tester provides for physician monitoring and control of an implantable human tissue stimulator system, such as an implantable cochlear stimulator (ICS) system. During normal operation, the tissue stimulator system includes an implantable stimulator and a wearable processor (WP). The physician's tester is designed around a microprocessor, and is basically a modification of the WP. The tester provides control over the selection of voltages and currents to be measured and the presetting of parameters in the implantable stimulator during testing of the implanted stimulator and/or a patient's response to data transmitted by the WP/tester to the implanted stimulator. The physician's testor is portable and utilizes telemetry coupling with the implanted stimulator to provide communication between the tester and stimulator for the monitoring, control and measurement of the stimulator parameters. The tester resides in a portable housing having a control panel and a visual display. The control panel allows the physician to manually set various parameter levels. The visual display provides alpha numeric data for viewing. Various devices, such as additional displays and/or a printer, may be coupled to the tester through a display port and/or an infrared serial output port in order to permit a print out of the displayed data or other information.

Physician's testing system and method for testing implantable cochlear

A tissue stimulating system including an external transmitter for transmitting data to an implanted stimulator including a processor for generating stimulation signals for application to a plurality of tissue stimulating electrodes. The processor selectively monitors the electrodes and/or voltages generated in the stimulator and generates stimulator status indicating signals for transmission to the external transmitter. The external processor receives and processes such status indicating signals.

Multichannel cochlear implant system including wearable speech processor

An external wearable processor (WP) of a cochlear stimulating system transmits a data signal to an implanted cochlear stimulator (ICS). The ICS is controlled through the data signal so that cochlear stimulation is provided by the ICS only after a determination is made that the WP is in proper signal contact therewith, and that the ICS is functioning properly. The ICS extracts a raw power signal from the data signal and generates different operating voltages from the extracted raw power signal. A detector generates a power bad signal whenever one of the operating voltages is less than a reference voltage. The ICS also detects and generates a carrier detect signal when the data signal is being received. Clock signals are generated within the ICS, and a phase locked loop (PLL) lock signal is generated when the clock signals are phase locked to the data signal. ICS circuitry further checks the parity of the incoming data signal and generates a parity alarm signal whenever a parity error is detected. A back telemetry carrier signal is transmitted from the ICS only when a prescribed combination of the carrier detect, PLL lock, power bad, and parity alarm signals exist. The back telemetry carrier signal, when received at the WP, is used as a handshake signal to signal the WP that the ICS is in proper signal communication with the WP, and that operation of the ICS can proceed.

Implantable cochlear stimulator having backtelemetry handshake signal

An implantable cochlear stimulator (ICS) has eight output stages (212), each having a programmable current source (212B) connected to a pair of electrodes, designated 'A' and 'B', through respective output coupling capacitors and an electrode switching matrix (212C). An indifferent electrode is connected to each output stage by way of an indifferent electrode switch (212D). An output mode register (208) controls the switching matrix of each stage, as well as the indifferent electrode switch, to configure the electrodes for: (1) bipolar stimulation (current flow between the pair of electrodes of the output stage), (2) monopolar A stimulation (current flow between the 'A' electrode of the output stage and the indifferent electrode), (3) monopolar B stimulation (current flow between the 'B' electrode of the output stage and the indifferent electrode), or (4) multipolar stimulation (current flow between the 'A' or 'B' electrode of one output stage and the 'A' or 'B' electrode of another output stage). The mode register is set by way of a command word, transmitted to the ICS from an external wearable system (10) as part of a data frame. The voltage at the 'A' and 'B' electrode of each output stage may be selectively telemetered to the wearable system, as may the current flow through the indifferent electrode, thereby facilitating a measurement of the electrode impedance. The 'A' and 'B' electrodes of each output stage may be selectively shorted through a high or low resistance in order to discharge the output coupling capacitors.

Multichannel implantable cochlear stimulator having programmable

A tissue stimulating system includes an external transmitter for transmitting a data signal to an implanted stimulator. The implanted stimulator includes a processor for generating stimulation signals for application to a plurality of tissue stimulating electrodes through respective isolated output channels. The implanted stimulator also includes a power supply that extracts a raw power signal from the data signal. A voltage downconverter generates at least four separate voltages from the extracted raw power signal by alternately connecting at least four capacitors in series across the raw power signal, thereby providing at least four output voltages, and then connecting the capacitors in parallel to transfer the charge stored thereon to a storage capacitor, which serves as the power source for portions of the stimulator. A selected one of the output voltages from the voltage downconverter is applied to an isolated refresh voltage capacitor in each output channel, where it controls a voltage controlled current source. The processor selectively monitors the electrodes and/or voltages generated in the stimulator and generates status indicating/measurement signals for transmission to the external transmitter. The external processor receives and processes the status indicating/measurement signals and uses the information therefrom to control the amount of power transmitted to the stimulator.

Voltage/current control system for a human tissue stimulator

An implantable microstimulator has a structure which is manufactured to be substantially encapsulated within a hermetically-sealed housing inert to body fluids, and of a size and shape capable of implantation in a living body. The internal structure of the microstimulator comprises a coil adapted to function as the secondary winding of a transformer and receive power and control information. Circuit means, including control electronics, a capacitor and electrodes are provided. The electrodes, which may be made one of iridium and the other of tantalum and placed on opposite ends of the microstimulator, or alternatively, an iridium electrode at each end of the microstimulator, are at least partially exposed and provide electrical, stimulating pulses to the body.

Structure and method of manufacture of an implantable microstimulator

An implantable microminiature stimulator and/or sensor (microdevice) is housed within a sealed housing that includes all the requisite electronic circuitry for inductively receiving power and control signals to sense of biopotential or other biomedical signals and/or to generate electrical stimulation pulse(s) between opposing electrodes. In a preferred embodiment, the housing of the microdevice is tubular, with opposing electrodes extending from each end. The electrodes are self-attaching electrodes that attach to a nerve or muscle without suturing. The electrodes are configured to helically curl around the desired nerve, thereby permitting the microdevice to stimulate the nerve or muscle, or sense signals associated with the nerve or muscle, using a minimal amount of energy. The electrodes and microdevice are sufficiently small to allow attachment to a single nerve, thereby preventing tethering of the nerve or muscle, and to allow their implantation within living tissue through small incisions or puncture holes. The muscle or nerve to which the microdevice is attached may be of any type, e.g., skeletal, smooth or cardiac.

Implantable microdevice with self-attaching electrodes

An addressable, implantable microstimulator is substantially encapsulated within a hermetically-sealed housing inert to body fluids, and of a size and shape capable of implantation in a living body, by expulsion through a hypodermic needle. Power and information for operating the microstimulator is received through a modulated, alternating magnetic field in which a coil is adapted to function as the secondary winding of a transformer. Electrical energy is stored in capacitor means and is released into the living body by controlled, stimulating pulses which pass through body fluids and tissue between the exposed electrodes of the microstimulator. Detection and decoding means within the microstimulator are provided for controlling the stimulating pulses in accordance with the modulation of the received, alternating magnetic field. Means for controllably recharging the capacitor is provided.

Implantable microstimulator

An implantable microstimulator has a structure which is manufactured to be substantially encapsulated within a hermetically-sealed housing inert to body fluids, and of a size and shape capable of implantation in a living body, by expulsion through a hypodermic needle. The internal structure of the microstimulator comprises a coil adapted to function as the secondary winding of a transformer and receive power and control information. Circuit means, including control electronics, a capacitor and electrodes are provided. The electrodes, which may be made one of iridium and the other of tantalum and placed on opposite ends of the microstimulator, or alternatively, an iridium electrode at each end of the microstimulator, are at least partially exposed and provide electrical, stimulating pulses to the body.

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Granada Hills, CA, United States of America

Primoz Strojnik