Subcutaneous cardiac sensing and stimulation system employing blood sensor

• US 7,302,294 B2
• Filed: 04/02/2004
• Issued: 11/27/2007
• Est. Priority Date: 04/11/2003
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Haefner, Paul, Brockway, Marina, Kamath, Apurv, Wagner, Darrell Orvin
• Primary Examiner(s): Manuel; George
• Assistant Examiner(s): Flory; Christopher A.
• Application Number:
  US10/817,749
• Publication Number:
  US 20040220629A1
• Time in Patent Office: 1,334 Days
• Field of Search: 607/6, 607/14, 607/18, 607/22, 600/6
• 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 and the detection and energy delivery circuitry, the processor configured to use the blood sensor signal to verify that the cardiac electrophysiologic signal comprises a cardiac signal, and configured to evaluate a cardiac rhythm using the blood sensor signal and the cardiac electrophysiologic signal comprising the cardiac signal.

2. The device of claim 1, wherein the blood sensor is configured for subcutaneous non-intrathoracic placement.

3. The device of claim 1, wherein the blood sensor is provided in or on the housing.

4. The device of claim 1, wherein the blood sensor comprises a sensor configured for optical signal sensing.

5. The device of claim 1, wherein the blood sensor comprises a blood oxygen saturation sensor.

6. The device of claim 1, wherein the blood sensor comprises a pulse oximeter.

7. The device of claim 1, wherein the blood sensor comprises a pulse oximeter, the pulse oximeter comprising at least two light-emitting diodes and at least one photodetector.

8. The device of claim 7, wherein a photodetector detection threshold is periodically adjusted to account for signal variations.

9. The device of claim 1, wherein the blood sensor comprises a pulse oximeter, the pulse oximeter comprising a first light-emitting diode having a peak light-emission wavelength within a range of about 550 nm and about 750 nm, and a second light-emitting diode having a peak light-emission wavelength within a range of about 750 nm and about 1050 nm.

10. The device of claim 1, wherein the blood sensor includes photoplethysmography circuitry.

11. The device of claim 1, wherein the processor identifies the cardiac rhythm as a tachyarrhythmia using the cardiac electrophysiologic signal and the blood sensor signal.

12. The device of claim 1, wherein the processor identifies the cardiac rhythm as a tachyarrhythmia using the cardiac electrophysiologic signal and a relative change in the blood sensor signal.

13. The device of claim 1, wherein the processor selectively activates and deactivates the blood sensor.

14. The device of claim 1, wherein the processor, in response to detecting a tachyarrhythmia using the cardiac electrophysiologic signal, activates the blood sensor and evaluates the tachyarrhythmia using the cardiac electrophysiologic signal and the blood sensor signal.

15. The device of claim 14, wherein the processor confirms presence of the tachyarrhythmia using the cardiac electrophysiologic signal and the blood sensor signal.

16. The device of claim 15, wherein the processor, in response to confirming presence of the tachyarrhythmia, delivers a therapy that treats the tachyarrhythmia, the processor deactivating the blood sensor before or after delivery of the therapy.

17. The device of claim 15, wherein the processor inhibits delivery of a tachyarrhythmia therapy until the processor confirms presence of the tachyarrhythmia using the blood sensor signal.

18. The device of claim 1, wherein the processor determines a hemodynamic state using the cardiac electrophysiologic signal and the blood sensor signal.

19. The device of claim 1, wherein the processor, in response to detecting an unidentifiable cardiac rhythm using the cardiac electrophysiologic signal, activates the blood sensor facilitating identification of the unidentifiable cardiac rhythm using the blood sensor signal.

20. The device of claim 1, wherein the at least one electrode is coupled to the housing via a lead and wherein the housing further comprises at least one housing electrode.

21. The device of claim 1, wherein the processor uses the blood sensor signal for assessing cardiac function.

22. The device of claim 1, wherein the processor uses the blood sensor signal for assessing oxygen saturation.

23. The device of claim 1, wherein the processor uses the blood sensor signal for assessing afterload.

24. The device of claim 23, wherein the processor assesses afterload by analyzing the morphology of the blood sensor signal.

25. A rhythm evaluation method, comprising:

sensing an electrocardiogram signal at a subcutaneous non-intrathoracic location;

acquiring a blood sense signal from a subcutaneous non-intrathoracic sensing location;

verifying that, using the blood sense signal, the electrocardiogram signal comprises a cardiac signal; and

evaluating a cardiac rhythm using the blood sense signal and the electrocardiogram signal comprising the cardiac signal.

26. The method of claim 25, wherein evaluating the cardiac rhythm comprises detecting a tachyarrhythmia using one or both of the electrocardiogram signal and the blood sense signal.

27. The method of claim 26, wherein detecting the tachyarrhythmia comprises performing a rate based analysis of the electrocardiogram signal.

28. The method of claim 26, wherein detecting the tachyarrhythmia comprises performing a morphology based analysis of the electrocardiogram signal.

29. The method of claim 26, wherein detecting the tachyarrhythmia comprises analyzing an activation pattern of the electrocardiogram signal using a plurality of electrodes.

30. The method of claim 26, further comprising treating the tachyarrhythmia.

31. The method of claim 25, wherein evaluating the cardiac rhythm comprises confirming presence of a tachyarrhythmia using the electrocardiogram signal and the blood sense signal.

32. The method of claim 25, wherein evaluating the cardiac rhythm comprises detecting a tachyarrhythmia using the electrocardiogram signal, and confirming presence of the tachyarrhythmia using the blood sense signal.

33. The method of claim 25, wherein evaluating the cardiac rhythm comprises detecting a tachyarrhythmia using the electrocardiogram signal, and discerning the detected tachyarrhythmia from noise using the blood sense signal.

34. The method of claim 25, wherein evaluating the cardiac rhythm comprises detecting a cardiac arrhythmia by performing a correlation between the electrocardiogram signal and the blood sense signal.

35. The method of claim 25, wherein evaluating the cardiac rhythm comprises detecting a cardiac tachyarrhythmia, and the method further comprises inhibiting delivery of a tachyarrhythmia therapy until presence of the tachyarrhythmia is confirmed using the blood sense signal.

36. The method of claim 25, wherein acquiring the blood sense signal comprises selectively powering-up and powering-down a blood sensor that produces the blood sense signal.

37. The method of claim 25, wherein evaluating the cardiac rhythm comprises:

detecting a tachyarrhythmia using the electrocardiogram signal;

powering-up a blood sensor that produces the blood sense signal in response to detecting the tachyarrhythmia;

confirming presence of the tachyarrhythmia using the blood sense signal; and

powering-down the blood sensor after confirming presence of the tachyarrhythmia.

38. The method of claim 37, further comprising:

treating the tachyarrhythmia; and

powering-down the blood sensor before or after treating the tachyarrhythmia.

39. The method of claim 25, wherein the blood sense signal comprises blood perfusion information.

40. The method of claim 25, wherein the blood sense signal comprises blood oxygen saturation information.

41. The method of claim 25, wherein the blood sense signal comprises photoplethysmographic information.

42. The method of claim 25, wherein the blood sense signal comprises pulse oximetry information.

43. An implantable subcutaneous device, comprising:

means for sensing an electrocardiogram signal at a subcutaneous non-intrathoracic location;

means for acquiring a blood sense signal from a subcutaneous non-intrathoracic sensing location;

means for verifying that, using the blood sense signal, the electrocardiogram signal comprises a cardiac signal; and

means for evaluating a cardiac rhythm using the blood sense signal and the electrocardiogram signal comprising the cardiac signal.

44. The device of claim 43, wherein the evaluating means further comprises means for detecting a tachyarrhythmia using one or both of the electrocardiogram signal and the blood sense signal.

45. The device of claim 44, further comprising means for treating the tachyarrhythmia.

46. The device of claim 43, wherein the evaluating means further comprises means for detecting a tachyarrhythmia and means for confirming presence of the tachyarrhythmia.

47. The device of claim 43, wherein the evaluating means comprises means for detecting a tachyarrhythmia using the electrocardiogram signal, and means for confirming presence of the tachyarrhythmia using the blood sense signal.

48. The device of claim 43, wherein the acquiring means comprises means for selectively powering-up and powering-down the means for sensing an electrocardiogram signal.

49. The device of claim 43, wherein the evaluating means comprises means for assessing cardiac function.

50. The device of claim 43, wherein the evaluating means comprises means for assessing afterload.

51. The device of claim 43, wherein the evaluating means comprises means for assessing oxygen saturation.

52. The device of claim 43, wherein the evaluating means comprises means for assessing changes in oxygen saturation.