Pre-qualification of an alternate sensing configuration

• US 7,953,488 B2
• Filed: 07/31/2008
• Issued: 05/31/2011
• Est. Priority Date: 07/31/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Casavant, David, Condie, Catherine R., Munsterman, Nathan, Spence, Jon W.
• Primary Examiner(s): Manuel; George
• Application Number:
  US12/183,971
• Publication Number:
  US 20100030289A1
• Time in Patent Office: 1,034 Days
• Field of Search: 607/9, 607/27
• US Class Current: 607/27
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/3686 configured for selecting the electrode configuration on a lead A61N1/3688 takes precedence
• CPC Class Codes: A61N 1/3704 Circuits specially adapted therefor, e.g. for sensitivity control
• CPC Class Codes: A61N 1/385 Devices for inducing an abnormal cardiac function, e.g. fibrillation
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Multiple sensing configurations may be qualified based on one induced tachyarrhythmia, e.g., ventricular fibrillation, or other qualification event during an implantation procedure. Each sensing configuration comprises a different combination of two or more electrodes used for sensing electrical signals of the heart of the patient. In some examples, an implantable medical device or other device generates qualification information for each sensing configuration, which may indicate whether the sensing configuration is qualified for subsequent cardiac event detection based on an accuracy of the cardiac event detection for the sensing configuration during the qualification event. One of the qualified configurations may initially be selected as a primary sensing configuration for subsequent cardiac event detection. Switching to an alternate sensing configuration, e.g., upon identification of any sensing integrity condition of the primary sensing configuration, may be expedited by the previous collection of qualification data for at least one other sensing configuration.

Claims

1. A method comprising:

receiving a plurality of sensed signals, each of the sensed signals sensed by a respective one of a plurality of sensing configurations during a qualification event;

analyzing each of the sensed signals to detect cardiac events during the qualification event;

generating qualification information for each of the sensing configurations based on the analysis, the qualification information for each of the sensing configurations indicating whether the sensing configuration is qualified for subsequent cardiac event detection based on an accuracy of the cardiac event detection for that sensing configuration during the qualification event;

identifying a first qualified one of the plurality of sensing configurations as a primary sensing configuration and a second qualified one of the plurality of sensing configurations as an alternate sensing configuration;

storing the qualification information for at least the alternate sensing configuration; and

receiving a signal sensed by the primary sensing configuration subsequent to the qualification event;

analyzing the signal received subsequent to the qualification event to detect cardiac events subsequent to the qualification event; and

subsequently switching, based on the previously stored qualification information for the alternate sensing configuration, from receiving and analyzing the signal sensed by the primary sensing configuration to receiving and analyzing a signal sensed by the alternate sensing configuration to detect cardiac events.

2. The method of claim 1, wherein each of the sensing configurations comprises a respective one of a plurality of different combinations of two or more electrodes from a plurality of electrodes implanted within a patient.

3. The method of claim 1, further comprising inducing a tachyarrhythmia during an implantation procedure that includes implanting an implantable medical device within the patient subsequent to the implantation, wherein the qualification event comprises the tachyarrhythmia induction.

4. The method of claim 1, wherein storing the qualification information comprises storing the qualification information within an implantable medical device.

5. The method of claim 1,

further comprising identifying a sensing integrity condition affecting the primary sensing configuration,

wherein subsequently switching from receiving and analyzing the signal sensed by the primary sensing configuration to receiving and analyzing the signal sensed by the alternate sensing configuration comprises switching from the primary sensing configuration to the alternate sensing configuration in response to the identification of the sensing integrity condition affecting the primary sensing configuration.

6. The method of claim 5, wherein switching from the primary sensing configuration to the alternate sensing configuration comprises:

presenting the stored qualification information for the alternate sensing configuration to a user in response to the identification of the sensing integrity condition affecting the primary sensing configuration;

receiving switching input from the user; and

switching from the primary sensing configuration to the alternate sensing configuration in response to the switching input.

7. The method of claim 5, wherein switching from the primary sensing configuration to the alternate sensing configuration comprises automatically switching from the primary sensing configuration to the alternate sensing configuration.

8. The method of claim 1, wherein the qualification information for the alternate sensing configuration comprises a marker channel for the alternate sensing configuration.

9. The method of claim 1, wherein analyzing each of the sensed signals comprises:

analyzing at least one of the signals substantially in real-time; and

storing and subsequently analyzing at least one other of the signals.

10. The method of claim 1, wherein the qualification event comprises a sinus rhythm assessment, and analyzing each of the sensed signals to detect cardiac events during the qualification event comprises analyzing each of the sensed signals to detect at least one of oversensing or undersensing of cardiac events.

11. The method of claim 1, wherein at least one of the sensing configurations comprises a physiological parameter sensor.

12. A method comprising:

receiving a plurality of sensed signals, each of the sensed signals sensed by a respective one of a plurality of sensing configurations during a qualification event;

analyzing each of the sensed signals to detect cardiac events during the qualification event; and

generating qualification information for each of the sensing configurations based on the analysis, the qualification information for each of the sensing configurations indicating whether the sensing configuration is qualified for subsequent cardiac event detection based on an accuracy of the cardiac event detection for that sensing configuration during the qualification event,

wherein receiving a plurality of sensed signals comprises;

receiving at least one of the signals with a narrow band filtered sense-amplifier; and

receiving at least one other of the signals with a wide band filtered sense-amplifier.

13. A system comprising:

a sensing module that receives a plurality of sensed signals, each of the sensed signals sensed by a respective one of a plurality of sensing configurations during a qualification event;

a processor that controls coupling of the sensing configurations to the sensing module; and

a memory,

wherein at least one of the sensing module and the processor analyzes each of the sensed signals to detect cardiac events during the qualification event,

wherein the processor generates qualification information for each of the sensing configurations based on the analysis, the qualification information for each of the sensing configurations indicating whether the sensing configuration is qualified for subsequent cardiac event detection based on an accuracy of the cardiac event detection for the sensing configuration during the qualification event,

wherein the processor identifies a first qualified one of the plurality of sensing configurations as a primary sensing configuration for subsequent cardiac event detection and a second qualified one of the plurality of sensing configurations as an alternate sensing configuration, controls subsequent cardiac event detection by the sensing module via the primary sensing configuration, and stores the qualification information for at least the alternate sensing configuration within the memory, and

wherein the processor subsequently switches the sensing module from the primary sensing configuration to the alternate sensing configuration for cardiac event detection based on the qualification information for the alternate sensing configuration previously stored within the memory.

14. The system of claim 13, further comprising a plurality of electrodes implanted within a patient, wherein each of the sensing configurations comprising a respective one of a plurality of different combinations of two or more electrodes from the plurality of electrodes.

15. The system of claim 14,

further comprising a signal generator,

wherein the processor controls the signal generator to deliver electrical stimulation to the patient via at least some of the electrodes to induces a tachyarrhythmia during an implantation procedure that includes implanting the plurality of electrodes within the patient subsequent to the implantation of the electrodes, and

wherein the qualification event comprises the tachyarrhythmia induction.

16. The system of claim 14, further comprising

an external analyzer coupled to the plurality of electrodes, wherein the external analyzer comprises the sensing module and the processor,

wherein the qualification event comprises a sinus rhythm assessment,

wherein at least one of the sensing module or the processor analyzes each of the sensed signals to detect at least one of oversensing or undersensing of cardiac events.

17. The system of claim 13, further comprising an implantable medical device, wherein the implantable medical device comprises the memory.

18. The system of claim 13, wherein the processor identifies a sensing integrity condition affecting the primary sensing configuration, and switches cardiac event detection by the sensing module from the primary sensing configuration to the alternate sensing configuration in response to the identification of the sensing integrity condition affecting the primary sensing configuration.

19. The system of claim 18, wherein the processor identifies the sensing integrity condition based on at least one of oversensing of cardiac events, undersensing of cardiac events, or a lead integrity condition.

20. The system of claim 18, further comprising a user interface that presents the stored qualification information for the alternate sensing configuration to a user in response to the identification of the sensing integrity condition affecting the primary sensing configuration, and receives switching input from the user, wherein the processor switches cardiac event detection by the sensing module from the primary sensing configuration to the alternate sensing configuration in response to the switching input.

21. The system of claim 13, wherein the qualification information for the alternate sensing configuration comprises a marker channel for the alternate sensing configuration.

22. The system of claim 13, further comprimising an implantable medical device, wherein the implantable medical device comprises the sensing module and the processor.

23. The system of claim 22, wherein the implantable medical device comprises and implantable pacemaker-cardioverter-defribrillator.

24. The system of claim 13, further comprising at least one physiological parameter sensor coupled to the sensing module, wherein at least one of the sensing configurations comprises the physiological parameter sensor.

25. A system comprising:

a plurality of electrodes implanted within a patient

a sensing module that receives a plurality of sensed signals, each of the sensed signals sensed by a respective one of a plurality of sensing configurations during a qualification event, wherein each of the sensing configurations comprises a respective one of a plurality of different combinations of two or more electrodes from the plurality of electrodes;

a processor that controls coupling of the sensing configurations to the sensing module; and

a memory,

wherein at least one of the sensing module and the processor analyzes each of the sensed signals to detect cardiac events during the qualification event,

wherein the processor generates qualification information for each of the sensing configurations based on the analysis, the qualification information for each of the sensing configurations indicating whether the sensing configuration is qualified for subsequent cardiac event detection based on an accuracy of the cardiac event detection for the sensing configuration during the qualification event,

wherein the sensing module comprises at least one narrow band filtered sense-amplifier that receives at least one of the sensed signals and at least one wide band filtered sense-amplifier that receives at least one other of the sensed signals,

wherein the sensing module analyzes the sensed signal received by the narrow band filtered sense-amplifier with the narrow band filtered sense-amplifier substantially in real-time, and

wherein the processor converts the sensed signal received by the wide band filtered sense-amplifier to a digital signal, stores the signal within the memory, and subsequently analyzes the digital signal to detect cardiac events that occurred during the qualification event.

26. A system comprising:

means for receiving a plurality of sensed signals, each of the sensed signals sensed by a respective one of a plurality of sensing configurations during a qualification event;

means for analyzing each of the sensed signals to detect cardiac events during the qualification event;

means for generating qualification information for each of the sensing configurations based on the analysis, the qualification information for each of the sensing configurations indicating whether the sensing configuration is qualified for subsequent cardiac event detection based on an accuracy of the cardiac event detection for the sensing configuration during the qualification event;

means for identifying a first qualified one of the plurality of sensing configurations as a primary sensing configuration and a second qualified one of the plurality of sensing configurations as an alternate sensing configuration; and

means for storing the qualification information for at least the alternate sensing configuration,

wherein the means for receiving receives a signal sensed by the primary sensing configuration subsequent to the qualification event and the means for analyzing analyzes the signal sensed by the primary sensing configuration subsequent to the qualification event to detect cardiac events subsequent to the qualification event,

the system further comprising means for subsequently switching, based upon the previously stored qualification information for the alternate sensing configuration, the means for receiving and the means for analyzing from the primary sensing configuration to the alternate sensing configuration to detect cardiac events.