Subcutaneous cardiac sensing and stimulation system employing blood sensor

• US 8,024,039 B2
• Filed: 10/17/2007
• Issued: 09/20/2011
• Est. Priority Date: 04/11/2003
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Kamath, Apurv, Wagner, Darrell Orvin, Haefner, Paul, Brockway, Marina
• Primary Examiner(s): Getzow; Scott M
• Assistant Examiner(s): PATTON, AMANDA K
• Application Number:
  US11/975,040
• Publication Number:
  US 20080091242A1
• Time in Patent Office: 1,434 Days
• Field of Search: 600/518, 607 5- 6
• US Class Current: 607/6
• CPC Class Codes: A61B 17/3203 Fluid jet cutting instruments
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2017/320084 Irrigation sleeves
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2090/3945 Active visible markers, e.g. light emitting diodes
• CPC Class Codes: A61B 2090/3979 infrared
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0568 with drug delivery
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/3925 : Monitoring; Protecting
• CPC Class Codes: A61N 1/3956 : Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/3962 : in combination with another heart therapy
• CPC Class Codes: A61N 1/39622 : Pacing therapy
• CPC Class Codes: A61N 1/3987 : characterised by the timing or triggering of the shock

Abstract

Cardiac systems and methods using ECG and blood information for arrhythmia detection and discrimination. Detection circuitry is configured to produce an ECG. An implantable blood sensor configured to produce a blood sensor signal is coupled to a processor. The processor is coupled to the detection and energy delivery circuitry, and used to evaluate and treat cardiac rhythms using both the cardiac electrophysiologic and blood sensor signals. The blood sensor is configured for subcutaneous non-intrathoracic placement and provided in or on the housing, on a lead coupled to the housing, and/or separate to the housing and coupled to the processor via hardwire or wireless link. The blood sensor may be configured for optical sensing, using a blood oxygen saturation sensor or pulse oximeter. A cardiac rhythm may be evaluated using the electrocardiogram signal and the blood sensor signal, and tachyarrhythmias may be treated after confirmation using the blood sense signal.

Claims

1. An implantable subcutaneous device, comprising:

a housing configured for subcutaneous non-intrathoracic placement;

detection circuitry provided in the housing and configured to produce a cardiac electrophysiologic signal;

energy delivery circuitry provided in the housing;

at least one electrode configured for subcutaneous non-intrathoracic placement and coupled to the detection and energy delivery circuitry;

an implantable blood sensor configured to produce a blood sensor signal; and

a processor provided in the housing and coupled to the blood sensor, the detection circuitry, and the energy delivery circuitry, the processor using the blood sensor signal to verify that the cardiac electrophysiologic signal comprises a cardiac signal having a QRS complex, the processor configured to discriminate between a tachyarrhythmia condition that requires cardioversion or defibrillation therapy and a condition that does not require cardioversion or defibrillation therapy using the cardiac electrophysiologic signal verified to have a QRS complex and the blood sensor signal, the processor configured to withhold delivery of cardioversion or defibrillation therapy in response to determining, using the blood sensor signal, that the condition does not require cardioversion or defibrillation therapy.

2. The device of claim 1, wherein the processor is configured to detect the tachyarrhythmia condition using the cardiac electrophysiologic signal and confirm presence of the tachyarrhythmia condition using the blood sensor signal.

3. The device of claim 1, wherein the processor is configured to identify a cardiac rhythm as the tachyarrhythmia condition using the cardiac electrophysiologic signal and a relative change in the blood sensor signal.

4. The device of claim 1, wherein the processor is configured to activate the blood sensor and evaluate the tachyarrhythmia condition using the cardiac electrophysiologic signal and the blood sensor signal in response to detecting the tachyarrhythmia condition using the cardiac electrophysiologic signal.

5. The device of claim 1, wherein the processor is configured to deliver the therapy to treat the tachyarrhythmia condition in response to confirming presence of the tachyarrhythmia condition, the processor configured to deactivate the blood sensor before or after delivery of the therapy.

6. The device of claim 1, wherein the processor is configured to discriminate between the tachyarrhythmia condition that requires the therapy and noise.

7. The device of claim 1, wherein the device comprises a plurality of electrodes, and the processor is configured to detect the tachyarrhythmia condition by analyzing an activation pattern of the cardiac electrophysiologic signal using the plurality of electrodes.

8. The device of claim 1, wherein the blood sensor comprises optical signal sensing circuitry, a blood oxygen saturation sensor, a pulse oximeter or photoplethysmography circuitry.

9. The device of claim 1, wherein the processor is configured, in response to detecting an unidentifiable cardiac rhythm using the cardiac electrophysiologic signal, to activate the blood sensor to facilitate identification of the unidentifiable cardiac rhythm using the blood sensor signal.

10. The device of claim 1, wherein the processor is configured to determine a hemodynamic state using the cardiac electrophysiologic signal and the blood sensor signal.

11. The device of claim 1, wherein the processor is configured to use the blood sensor signal for assessing oxygen saturation.

12. The device of claim 1, wherein the processor is configured to deliver the therapy to treat the tachyarrhythmia condition in response to confirming presence of the tachyarrhythmia condition.

13. The device of claim 1, wherein the processor is configured to discriminate between the tachyarrhythmia condition that requires the cardioversion or defibrillation therapy and the condition that does not require the cardioversion or defibrillation therapy by performing a correlation between the electrocardiogram signal and the blood sense signal.

14. The device of claim 1, wherein the processor is configured to selectively power-up the blood sensor for producing the blood sensor signal based on an indication of arrhythmia identified from the cardiac electrophysiologic signal.

15. The device of claim 1, wherein the processor is configured to, in response to detecting an unidentifiable cardiac rhythm using the cardiac electrophysiologic signal, power-up the blood sensor facilitating identification of the unidentifiable cardiac rhythm using the blood sensor signal and discrimination between the tachyarrhythmia condition that requires cardioversion or defibrillation therapy and the condition that does not require cardioversion or defibrillation therapy.

16. The device of claim 1, wherein the processor is configured to use the blood sensor signal for assessing afterload by analyzing the morphology of the blood sensor signal.

17. The device of claim 1, wherein the processor is configured to identify the tachyarrhythmia condition based on the cardiac electrophysiologic signal and a relative change in the blood sensor signal.

18. The device of claim 1, wherein the processor, in response to detecting a tachyarrhythmia using the cardiac electrophysiologic signal, is configured to activate the blood sensor and evaluate the tachyarrhythmia using the cardiac electrophysiologic signal and the blood sensor signal to discriminate between the tachyarrhythmia condition that requires cardioversion or defibrillation therapy and the condition that does not require cardioversion or defibrillation therapy.

19. An implantable subcutaneous device, comprising:

a housing configured for subcutaneous non-intrathoracic placement;

detection circuitry provided in the housing and configured to produce a cardiac electrophysiologic signal;

energy delivery circuitry provided in the housing;

at least one electrode configured for subcutaneous non-intrathoracic placement and coupled to the detection and energy delivery circuitry;

an implantable photoplethysmography sensor configured for deployment between a layer of skin and a layer of extrathoracic muscle tissue and having a photodetector arrangement oriented towards the muscle tissue, and to produce a blood sensor signal; and

a processor provided in the housing and coupled to the blood sensor, the detection circuitry, and the energy delivery circuitry, the processor configured to identify an indication of a tachyarrhythmia condition based on the cardiac electrophysiologic signal, activate the blood sensor to produce the blood sensor signal based on the identification of the indication of the tachyarrhythmia condition, verify that the cardiac electrophysiologic signal comprises a QRS complex using the blood sensor signal, confirm presence of the tachyarrhythmia condition based on the cardiac electrophysiologic signal verified to have a QRS complex and the blood sensor signal, and initiate delivery of an electrical cardiac therapy to treat the tachyarrhythmia condition using the energy delivery circuitry based on the confirmed presence of the tachyarrhythmia condition, wherein the electrical cardiac therapy is withheld by the processor if the tachyarrhythmia condition is not confirmed from the blood sensor signal.

20. The device of claim 19, wherein the implantable photoplethysmography sensor is configured to be oriented toward the muscle tissue in a manner that reduces interference from ambient light sources.

21. The device of claim 19, comprising an opaque barrier arranged to direct light into the photodetector arrangement of the implantable photoplethysmography sensor.

22. The device of claim 19, wherein the processor is configured to cooperate with the photoplethysmography sensor to verify that the cardiac electrophysiologic signal comprises a cardiac signal having a QRS complex.

23. The device of claim 22, wherein the processor is configured to discriminate between a tachyarrhythmia condition that requires a cardioversion or defibrillation therapy and a condition that does not require cardioversion or defibrillation therapy using the cardiac electrophysiologic signal verified to have a QRS complex and the blood sensor signal.