Physician's testing system and method for testing implantable cochlear stimulator

• US 5,609,616 A
• Filed: 05/25/1995
• Issued: 03/11/1997
• Est. Priority Date: 09/22/1989
• Status: Expired due to Term

• Current Assignee: Alfred E. Mann Foundation For Scientific Research
• Original Assignee: Alfred E. Mann Foundation For Scientific Research
• Inventors: Schulman, Joseph H., Gord, John C., Strojnik, Primoz, Whitmoyer, David I.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US08/447,157
• Time in Patent Office: 656 Days
• Field of Search: 607/27-32, 607/59-60, 607/56, 607/57
• US Class Current: 607/56
• CPC Class Codes: A61N 1/36038 Cochlear stimulation
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: H04R 2225/67 Implantable hearing aids or parts thereof not covered by H04R25/606
• CPC Class Codes: H04R 2460/03 Aspects of the reduction of energy consumption in hearing devices
• CPC Class Codes: H04R 25/505 using digital signal processing

Abstract

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.

Claims

1. A physician'"'"'s testing system for testing a multichannel cochlear stimulating system, comprising a physician'"'"'s tester, an external headpiece/transmitter, and an implanted cochlear stimulator (ICS),

the external headpiece/transmitter having transmitting means for transmitting data-containing signals to the ICS;

the ICS comprising;

(a) receiving means for receiving the data-containing signals, (b) processor means for processing the data-containing signals to generate stimulation signals, (c) a plurality of tissue-stimulating electrodes for receiving the stimulation signals, (d) monitor means in the processor means and responsive to the data-containing signals for (1) selectively monitoring at least one pair of the tissue-stimulating electrodes as one of the stimulation signals is applied thereto to measure a voltage associated with said pair of electrodes, and (2) generating stimulator status-indicating signals, and (e) telemetry means for transmitting the stimulator status-indicating signals to the external headpiece/transmitter means; and

the physician'"'"'s tester comprising;

external processor means coupled to the transmitting means of the external headpiece/transmitter for receiving and processing the status-indicating signals to derive information therefrom regarding the operation of the implanted stimulator and its plurality of tissue stimulating electrodes;

user-controllable means connected to the external processor means for selectively generating and controlling the data-containing signals transmitted by the transmitting means of the external headpiece/transmitter means, said user-controllable means including manual means for specifying a peak output current for the stimulation signals to be applied to the at least one pair of tissue-stimulating electrodes; and

display means for displaying the information derived from the status-indicating signals.

2. The physician'"'"'s testing system of claim 1 wherein the external processor means of the physician'"'"'s tester includes a microprocessor, said microprocessor having a parallel output port coupled thereto through which information derived from the status-indicating signals may be coupled to a remote site.

3. The physician'"'"'s testing system of claim 1 wherein the external processor means of the physician'"'"'s tester includes a microprocessor, said microprocessor having a printer port coupled thereto through which information derived from the status-indicating signals may be sent.

4. The physician'"'"'s testing system of claim 1 wherein the manual means of the user-controllable means of the physician'"'"'s tester further includes means for specifying a particular pair of the plurality of tissue-stimulating electrodes at which the monitor means of the ICS is to measure a voltage.

5. The physician'"'"'s testing system of claim 4 wherein the external-processor means includes means for computing an impedance measurement based on the voltage measured by the monitor means of the ICS and the peak output current specified by the manual means of the user-controllable means.

6. The physician'"'"'s testing system of claim 4 wherein the ICS includes a current-sensing resistor within the ICS through which a current associated with a stimulating signal applied to a select pair of the tissue-stimulating electrodes must pass, and wherein said monitor means within said ICS includes means for measuring a voltage across said current-sensing resistor, which voltage provides a measure of a stimulating current flowing through the select pair of electrodes, and wherein the external-processor means of the physician'"'"'s tester includes means for computing an impedance measurement based on the voltage and current measured by the monitor means of the ICS.

7. The physician'"'"'s testing system of claim 1 wherein the external processor means of the physician'"'"'s tester includes a microprocessor, said microprocessor having an RS232 output port coupled thereto through which information derived from the status-indicating signals may be sent to a remote site.

8. The physician'"'"'s testing system of claim 1 wherein the manual means for specifying the peak output current, included as part of the user-controllable means of the physician'"'"'s tester, comprises a manual switch having means for selecting one of at least seven separate peak output current settings.

9. The physician'"'"'s testing system of claim 8 wherein the at least seven separate peak output current settings of the manual switch include 0, 0.5, 1.0, 10, 100, 1000 and 2500 μ

a.

10. A method of testing an implantable tissue stimulating system comprising:

transmitting data-containing signals to an implanted stimulator from an external transmitter;

selectively controlling the data-containing signals as they are thus transmitted;

receiving the data-containing signals within the implanted stimulator, the implanted stimulator having a multiplicity of tissue-stimulating electrodes;

processing the data-containing signals within the implanted stimulator to generate stimulation signals;

applying the stimulation signals to at least one pair of the multiplicity of tissue stimulating electrodes;

selectively monitoring the at least one pair of the multiplicity of electrodes to measure a voltage associated therewith at the same time the stimulation signals are applied thereto;

generating stimulator status-indicating signals representative of the measurements made within the implanted stimulator;

transmitting the stimulator status-indicating signals to an external receiver coupled to the external transmitter;

receiving and processing the status-indicating signals to produce processed status-indicating signals which convey information regarding the status of the implanted stimulator, including the measurements made within the implanted stimulator; and

displaying the processed status-indicating signals, whereby the status of the implanted stimulator, including the results of the measurements made within the implanted stimulator, may be made known.

11. The method of claim 10 further including printing the processed status-indicating signals, whereby the status of the implanted stimulator, including the results of the measurements made within the implanted stimulator, may be preserved on a printed record.

12. A system for testing an implantable cochlear stimulator (ICS) comprising a portable physician'"'"'s tester and the ICS,

the ICS comprising (a) receiver means for receiving data-containing signals, (b) processor means for processing the received data-containing signals to generate stimulation signals, the stimulation signals having a peak output current associated therewith prescribed by the data-containing signals, (c) a multiplicity of tissue-stimulating electrodes;

(d) means for applying the stimulation signals to selected pairs of the multiplicity of tissue stimulating electrodes, (e) monitor means in the processor and responsive to the data-containing signals received by the receiver means for (1) monitoring a selected pair of the multiplicity of electrodes as one of the stimulation signals is applied thereto to measure a voltage associated therewith, and (2) generating stimulator status-indicating signals, said stimulator status-indicating signals including the voltage measured at the selected pair of electrodes by the monitor means as one of the stimulation signals is applied thereto, and (f) telemetry means for transmitting the stimulator-status indicating signals to an external receiver;

the portable physician'"'"'s tester comprising;

user-controllable means for selectively generating the data-containing signals, said user-controllable means including manual means for manually specifying a peak output current to be included in the data-containing signals;

external transmitter means for transmitting the data-containing signals to the receiver means of the ICS;

external receiver means for receiving the status-indicating signals transmitted by the telemetry means of the ICS;

external processor means for processing the received status-indicating signals to derive information therefrom regarding the operation of the ICS and its plurality of tissue stimulating electrodes; and

display means for displaying the information derived from the status-indicating signals.

13. The system for testing of claim 12 wherein the portable physician'"'"'s tester further includes a signal port coupled to the external processor means through which the information derived from the status-indicating signals may be sent for further processing at a location removed from the external processor means.

14. The system for testing of claim 12 wherein the manual means of the user-controllable means of the portable physician'"'"'s tester further includes means for manually specifying a particular pair of the plurality of tissue-stimulating electrodes at which the monitor means of the ICS is to measure a voltage.