Calibration system for pacemaker-generated intracardiac electrogram

• US 5,620,473 A
• Filed: 03/08/1995
• Issued: 04/15/1997
• Est. Priority Date: 03/08/1995
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Poore, John W.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US08/400,646
• Time in Patent Office: 769 Days
• Field of Search: 607/27, 607/32, 607/60, 607/31, 607/28
• US Class Current: 607/27
• CPC Class Codes: A61N 1/37254 Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals

Abstract

A calibration system for use with an implantable pacemaker allows the intracardiac electrogram (IEGM) generated by the pacemaker to be calibrated when the pacemaker is coupled to an external programmer. The calibration system includes telemetry circuits within both the pacemaker and programmer that allow data signals to be sent from the pacemaker to the programmer, and that allow command signals to be sent from the programmer to the pacemaker, in conventional manner. The system further includes circuitry within the pacemaker that generates a precision reference voltage as well as a zero reference voltage, and that selectively switches the precision reference voltage and/or the zero reference voltage into the IEGM data signals being telemetered to the external programmer from the pacemaker. The switching of the precision reference voltage and/or zero reference voltage into the IEGM data occurs within the pacemaker upon receipt of a special calibration command signal from the programmer. Such reference voltages, when thus included as part of the telemetry data received from the pacemaker, is thereafter included in the display or storage of the IEGM at the programmer, and may be used to scale the IEGM display so that it fits a calibrated n mv/div graticule. The precision reference voltage thus provides a known calibrated reference against which the IEGM can be compared in order to provide a true measure of its amplitude at any given time.

Claims

1. A cardiac pacemaker system comprising:

an implanted pacemaker, the pacemaker having means for sensing intracardiac electrogram (IEGM) signals and means for telemetering such IEGM signals to a remote receiver;

an external programmer in telemetered contact with the implanted pacemaker, the programmer having;

receiver means for receiving the IEGM signals telemetered from the implanted pacemaker,

processing means for processing the received IEGM signals for display, and

display means for displaying the processed IEGM signals as a function of a selected time base;

the implanted pacemaker further having;

means for generating a plurality of voltage reference signals, each having a fixed magnitude,

means responsive to a calibrate signal for inserting a prescribed sequence of the plurality of voltage reference signals in a data stream of the sensed IEGM signals telemetered to the programmer, and

implanted receiver means for receiving control signals from the external programmer; and

the external programmer further having;

means for selectively generating the calibrate signal, and

means for coupling the calibrate signal to the implanted receiver, thereby causing the prescribed sequence of the plurality of voltage reference signals to be included in the data stream received from the implanted pacemaker;

whereby the sequence of voltage reference signals, when selectively inserted into the data stream of the sensed IEGM signals, becomes part of the IEGM signals displayed by the display means of the external programmer, and

whereby the fixed magnitude of the plurality of voltage reference signals thus displayed can be used to calibrate the display of the IEGM.

2. The pacemaker system of claim 1, wherein the means for selectively generating the calibrate signal in the external programmer includes:

switch means for manually activating a calibrate function; and

command signal generating means responsive to activation of the switch means for generating the calibrate signal.

3. The pacemaker system of claim 2, wherein the switch means includes:

a transparent touch sensitive membrane placed over a display screen of the external programmer;

means for displaying a calibrate button on the display screen; and

means responsive to touching the membrane at a location that is over the displayed calibrate button on the display screen for generating the calibrate signal.

4. The pacemaker system of claim 1, wherein the means for selectively generating the calibrate signal in the external programmer comprises means for automatically generating the calibrate signal whenever the data stream of IEGM signals is being received from the implanted pacemaker.

5. The pacemaker system of claim 1, wherein the means for selectively generating the calibrate signal in the external programmer comprises means for periodically generating the calibrate signal whenever the data stream of IEGM signals is being received from the implanted pacemaker.

6. The pacemaker system of claim 1, wherein the means for generating the plurality of voltage reference signals comprises means for generating a reference voltage pulse having a fixed amplitude that is inserted into the data stream of the sensed IEGM signals.

7. The pacemaker system of claim 6, wherein the means for generating the plurality of voltage reference signals comprises a zero reference voltage V_ZERO, and a reference voltage, V_REF, and means for generating a V_ZERO -V_REF -V_ZERO sequence that is interleaved with the data stream of the sensed IEGM signals.

8. The pacemaker system of claim 7, wherein the V_ZERO -V_REF -V_ZERO sequence comprises no more than about 5 ms of a V_ZERO signal, followed by no more than about 20 ms of a V_REF signal, followed by no more than about 5 ms of the V_ZERO signal.

9. The pacemaker system of claim 1, wherein the display means of the external programmer comprises an electronic display screen upon which the processed IEGM signals and the plurality of reference voltage signals are displayed.

10. The pacemaker system of claim 1, wherein the display means of the external programmer comprises a printer that prints the processed IEGM signals and the plurality of reference voltage signals in a tangible medium.

11. An IEGM calibration system comprising an implantable pacemaker and an external programmer, the implantable pacemaker comprising:

a receiver that receives control signals from a remote transmitter;

sensing means for sensing intracardiac electrogram (IEGM) signals;

telemetry means for telemetering the IEGM signals to a remote receiver;

a voltage source that generates a plurality of fixed-level precision reference voltages; and

a switching circuit, responsive to a calibration control signal, that switches a prescribed sequence of the plurality of fixed-level precision reference voltages into a data stream of the sensed IEGM signals that are telemetered to the remote receiver;

the external programmer comprising;

the remote receiver,

the remote transmitter,

processing means for processing the received IEGM signals for display,

display means for displaying the processed IEGM signals as a function of a selected time base,

means for selectively generating the calibration control signal and transmitting it to the implanted receiver within the pacemaker through the remote transmitter, thereby causing the prescribed sequence of the plurality of fixed-level precision reference voltages to be interleaved with the IEGM signals telemetered to the programmer,

whereby the precision reference voltage may be selectively included within the IEGM signals that are received by the remote receiver and processed for calibration purposes by the processing means of the external programmer.

12. The IEGM calibration system of claim 11, wherein the external programmer further includes memory means for storing the processed IEGM signals and plurality of fixed-level precision reference voltages for later display and analysis.

13. The IEGM calibration system of claim 11, wherein the switching circuit of the implanted pacemaker includes means for inserting the plurality of fixed-level precision reference voltages into the data stream of IEGM signals as a sequence that defines a pulse having a fixed amplitude.

14. The IEGM calibration system of claim 11, wherein the switching circuit of the implanted pacemaker has at least first, second, third and fourth states, a first state during which a first of the plurality of fixed-level precision reference voltages is momentarily inserted into the data stream, a second state during which a second of the plurality of fixed-level precision reference voltages is inserted into the data stream, a third state during which the first of the plurality of fixed-level precision reference voltages is again momentarily inserted into the data stream, and a fourth state during which the IEGM data signals are inserted into the data stream, and further including means responsive to the calibration control signal for controlling the switching circuit so that it assumes in sequence its first, second and third states whenever the calibration control signal is received by the implanted receiver of the pacemaker, and so that it assumes its fourth state whenever the calibration control signal is not received by the implanted receiver, whereby the plurality of fixed-level precision reference voltages appear as a fixed voltage level relative to the first fixed-level reference voltage in the data stream for so long as the calibration control signal is received.

15. The IEGM calibration system of claim 11, wherein the voltage source of the implantable pacemaker includes:

means for generating a calibrate pulse of a fixed duration in response to receipt of the calibration control signal; and

means for energizing the voltage source for the duration of the calibrate pulse, whereby the voltage reference source generates the plurality of fixed-level precision reference voltages only for the duration of the calibrate pulse.

16. A method of verifying the system gain of a pacing system, the pacing system comprising an implantable pacemaker and an external programmer, implantable pacemaker having means for sensing IEGM signals, means for transmitting the IEGM signals to an external receiver, and means for receiving command signals from a remote transmitter, the method comprising:

(a) establishing a data link between the pacemaker and the external programmer, the external programmer including the remote receiver and the remote transmitter;

(b) transmitting the IEGM signals from the pacemaker to the external programmer;

(c) receiving the IEGM signals at the external programmer;

(d) generating a calibrate command signal at the external programmer and sending the calibrate command signal to the pacemaker through the established data link;

(e) receiving the calibrate command signal within the pacemaker and, in response thereto, generating a plurality of fixed-level reference signals that are interleaved with the IEGM signals being telemetered to the external programmer, the plurality of fixed-level reference signals each having a known magnitude;

(f) receiving the plurality of fixed-level reference signals at the external programmer interleaved with the IEGM signals; and

(g) processing the received IEGM signals with the received fixed-level reference signals in order to verify the system gain of the pacing system, the system gain being manifest from the magnitude of the received IEGM signals as scaled to the known magnitude of the received fixed-level reference signals.

17. The method of claim 16, further including storing the IEGM signals and plurality of fixed-level reference signals at the external programmer.

18. The method of claim 16, further including displaying the IEGM signals and plurality of fixed-level reference signals on a display device coupled to the external programmer.

19. The method of claim 18, wherein displaying the IEGM signals and reference signal on the display device comprises adding the reference signal to the IEGM signals for a prescribed period of time to produce a summed signal, and displaying such summed signal on the display device.

20. A cardiac pacemaker system comprising:

an implanted pacemaker, the pacemaker having means for sensing intracardiac electrogram (IEGM) signals and means for telemetering such IEGM signals to a remote receiver;

an external programmer in telemetered contact with the implanted pacemaker, the programmer having;

receiver means for receiving the IEGM signals telemetered from the implanted pacemaker,

processing means for processing the received IEGM signals for display, and

display means for displaying the processed IEGM signals as a function of a selected time base;

the implanted pacemaker further having;

means for generating a reference voltage signal having a selectable fixed amplitude,

means for adding the reference voltage level to the IEGM data signals during a portion of the data stream,

means responsive to a calibrate signal for inserting the reference voltage signal in a data stream of the sensed IEGM signals telemetered to the programmer, and

implanted receiver means for receiving control signals from the external programmer; and

the external programmer further having;

means for selectively generating the calibrate signal, and

means for coupling the calibrate signal to the implanted receiver, thereby causing the reference voltage signal to be included in the data stream received from the implanted pacemaker;

whereby the reference voltage signal, when selectively inserted into the data stream of the sensed IEGM signals, becomes part of the IEGM signals displayed by the display means of the external programmer, and

whereby the fixed magnitude of the reference voltage signal thus displayed can be used to calibrate the display of the IEGM.

21. A method of verifying the system gain of a pacing system, the pacing system comprising an implantable pacemaker and an external programmer, implantable pacemaker having means for sensing IEGM signals, means for transmitting the IEGM signals to an external receiver, and means for receiving command signals from a remote transmitter, the method comprising:

(a) establishing a data link between the pacemaker and the external programmer, the external programmer including the remote receiver and the remote transmitter;

(b) transmitting the IEGM signals from the pacemaker to the external programmer;

(c) receiving the IEGM signals at the external programmer;

(d) generating a calibrate command signal at the external programmer and sending the calibrate command signal to the pacemaker through the established data link;

(e) receiving the calibrate command signal within the pacemaker and, in response thereto, generating a reference signal that is included within the IEGM signals being telemetered to the external programmer, the reference signal having a known magnitude;

(f) receiving the reference signal at the external programmer with the IEGM signals;

(g) adding the reference signal to the IEGM signals for a prescribed period of time to produce a summed signal, and displaying such summed signal on a display device coupled to the external programmer; and

(h) processing the received IEGM signals with the received reference signal in order to verify the system gain of the pacing system, the system gain being manifest from the magnitude of the received IEGM signals as scaled to the known magnitude of the received reference signal.

22. An implantable pacemaker comprising:

means for sensing intracardiac electrogram (IEGM) signals;

means for telemetering the IEGM signals to a remote receiver;

a voltage source that provides a first reference voltage having a fixed magnitude;

means for receiving a calibrate signal; and

switch means responsive to receipt of the calibrate signal for adding the first reference voltage to the IEGM signals telemetered to the remote receiver for a prescribed time period;

the fixed magnitude of the first reference voltage thereby providing a way to calibrate the magnitude of the IEGM signals.

23. The implantable pacemaker of claim 22, wherein the voltage source additionally provides a second reference voltage, and wherein the switch means is for further adding the second reference voltage to the IEGM signals telemetered to the remote receiver.

24. The implantable pacemaker of claim 23, wherein the switch means adds the first and second reference voltages to the IEGM signals telemetered to the remote receiver in a prescribed sequence.

25. The implantable pacemaker of claim 24, wherein the prescribed sequence comprises the second reference voltage for no more than about 5 ms, followed by the first reference voltage for no more than about 20 ms, followed by the second reference voltage for no more than about 5 ms.