Method and apparatus for monitoring heart function in a subcutaneously implanted device

• US 7,035,684 B2
• Filed: 02/26/2003
• Issued: 04/25/2006
• Est. Priority Date: 02/26/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Lee, Brian B.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US10/376,062
• Publication Number:
  US 20040167416A1
• Time in Patent Office: 1,154 Days
• Field of Search: 607 18- 20, 607/28, 607/36, 607/37, 600513-515, 600/485, 600/486
• US Class Current: 600/513
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/0883 for diagnosis of the heart
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/488 involving Doppler signals
• 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 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

A minimally invasive, implantable monitor and associated method for chronically monitoring a patient'"'"'s hemodynamic function based on signals sensed by one or more acoustical sensors. The monitor may be implanted subcutaneously or submuscularly in relation to the heart to allow acoustic signals generated by heart or blood motion to be received by a passive or active acoustical sensor. Circuitry for filtering and amplifying and digitizing acoustical data is included, and sampled data may be continuously or intermittently written to a looping memory buffer. ECG electrodes and associated circuitry may be included to simultaneously record ECG data. Upon a manual or automatic trigger event acoustical and ECG data may be stored in long-term memory for future uploading to an external device. The external device may present acoustical data visually and acoustically with associated ECG data to allow interpretation of both electrical and mechanical heart function.

Claims

1. An implantable medical device for monitoring heart function of a patient'"'"'s heart, comprising:

a housing portion enclosing operative circuitry of the device;

a plurality of electrodes, electrically coupled to the circuitry, configured for detecting cardiac depolarization events from one of a subcutaneous position extravascular and a submuscular position extravascular;

a sensor, electrically coupled to the circuitry, configured for detecting pressure waves corresponding to the heart function from one of a subcutaneous and a submuscular position extravascular;

a storage device storing data corresponding to the cardiac depolarizations and the pressure waves coupled to the operative circuitry; and

a control unit controlling the sensor and storage of the data in the storage device in response to one of the detected cardiac depolarizations and the detected pressure waves.

2. The implantable medical device of claim 1, further comprising a communication unit configured for receiving a patient input, wherein the control unit controls the sensor and storage of the data in the storage device in response to the detected cardiac depolarizations, the detected pressure waves, and the patient input.

3. The implantable medical device of claim 1, further comprising;

a sensor assembly including the sensor; and

a coupling device electrically coupling the sensor assembly to the housing portion, the sensor assembly having a first thickness and the housing portion having a second thickness greater than the first thickness.

4. The implantable medical device of claim 3, wherein the sensor includes a transmitter and a receiver, one of the transmitter and the receiver positioned along the sensor assembly and the other of the transmitter and receiver positioned along the housing portion.

6. The implantable medical device of claim 1, wherein the sensor is adapted to be positioned along soft tissue between the housing and the heart.

7. The implantable medical device of claim 1, wherein the sensor is adapted to be positioned along a suprasternal notch.

8. The implantable medical device of claim 1, wherein the sensor is adapted to be positioned over an intercostal space.

9. The implantable medical device of claim 3, wherein the sensor assembly is adapted to be positioned along a suprasternal notch.

10. The implantable medical device of claim 3, wherein the sensor assembly is adapted to be positioned over an intercostal space.

11. The implantable medical device of claim 3, wherein the plurality of electrodes includes a first electrode and a second electrode positioned along the housing portion, and a third electrode positioned along the sensor assembly.

12. The implantable medical device of claim 1, wherein the storage device includes a first memory portion and a second memory portion, and wherein the control unit stores simultaneously detected cardiac depolarizations and corresponding pressure waves in the first memory portion.

13. The implantable medical device of claim 12, wherein the storage unit stores the data stored in the first memory portion and subsequently detected cardiac depolarizations and detected pressure waves in the second memory portion in response to one of the detected cardiac depolarizations and the detected pressure waves.

14. The implantable medical device of claim 13, wherein the detected pressure waves are indicative of one of hemodynamic events of the heart and physical activity of the patient.

15. The implantable medical device of claim 13, wherein the control unit stores data stored in the first memory portion and subsequent detected cardiac depolarizations and detected pressure waves in the second memory portion in response to a patient activation.

5. The implantable medical device of 3, wherein the sensor includes a transmitter and a receiver, both the transmitter and the receiver positioned along one of the sensor assembly and the housing portion.

16. A method of monitoring heart function of a patient'"'"'s heart from one of a subcutaneous and a submuscular position extravascular, comprising the steps of:

detecting cardiac depolarizations from one of a subcutaneous and a submuscular position extravascular and storing data corresponding to the detected cardiac depolarizations in a first memory portion;

determining whether a cardiac event is detected in response to the detected depolarizations; and

detecting pressure waves corresponding to the heart function from one of a subcutaneous and a submuscular position extravascular, storing the data stored in the first memory portion and subsequently detected cardiac depolarizations and detected pressure waves in a second memory portion in response to a cardiac event being detected.

17. The method of claim 16, wherein the step of detecting cardiac depolarizations further comprises detecting the pressure waves simultaneously with the cardiac depolarizations and storing data corresponding to the simultaneously detected pressure waves and cardiac depolarizations in the first memory portion.

18. The method of claim 17, further comprising the step of storing the data stored in the first memory portion and subsequently detected cardiac depolarizations and detected pressure waves in the second memory portion in response to one of the detected cardiac depolarizations and the detected pressure waves.

19. The method of claim 18, wherein the detected pressure waves are indicative of one of hemodynamic events of the heart and physical activity of the patient.

20. The method of claim 18, wherein data stored in the first memory portion and subsequently detected cardiac depolarizations and detected pressure waves are stored in the second memory portion in response to a patient activation.

21. An implantable medical device system device for monitoring heart function of a patient'"'"'s heart from one of a subcutaneous and a submuscular position, extravascular comprising:

a housing portion housing circuitry of the device;

a plurality of electrodes, electrically coupled to the circuitry, adapted for detecting cardiac depolarizations from one of a subcutaneous and a submuscular position extravascular;

a sensor, electrically coupled to the circuitry, adapted for detecting pressure waves corresponding to the heart function from one of a subcutaneous and a submuscular position;

extravascular

a storage device storing data corresponding to the cardiac depolarizations and the pressure waves;

a control unit controlling the sensor and storage of the data in the storage device in response to the detected cardiac depolarizations and the detected pressure waves;

an external device receiving and processing the stored data from the storage device; and

a display unit couple to the external device displaying the cardiac depolarizations and the pressure waves.

22. The implantable medical device system of claim 21, wherein the pressure waves include low frequency and high frequency acoustic data, and wherein the detected cardiac depolarizations are displayed graphically on the display unit with the low frequency and high frequency acoustic data.

23. The implantable medical device system of claim 21, further comprising an acoustical output device coupled to the external device, and wherein the detected cardiac depolarizations are displayed graphically on the display unit and the corresponding pressure waves are output acoustically by the output device simultaneously with the displayed cardiac depolarizations.

24. The implantable medical device of claim 21, further comprising;

a sensor assembly including the sensor; and

a coupling device electrically coupling the sensor assembly to the housing portion, the sensor assembly having a first thickness and the housing portion having a second thickness greater than the first thickness.

25. The implantable medical device of claim 24, wherein the sensor includes a transmitter and a receiver, one of the transmitter and the receiver positioned along the sensor assembly and the other of the transmitter and receiver positioned along the housing portion.

27. The implantable medical device of claim 24, wherein the sensor assembly is adapted to be positioned along a suprasternal notch.

28. The implantable medical device of claim 24, wherein the sensor assembly is adapted to be positioned over an intercostal space.

29. The implantable medical device of claim 24, wherein the plurality of electrodes include, a first electrode and a second electrode positioned along the housing portion, and a third electrode positioned along the sensor assembly.

30. The implantable medical device of claim 21, wherein the sensor is adapted to be positioned along soft tissue between the housing and the heart.

31. The implantable medical device of claim 21, wherein the sensor is adapted to be positioned along a suprasternal notch.

32. The implantable medical device of claim 21, wherein the sensor is adapted to be positioned over an intercostal space.

33. The implantable medical device of claim 21, wherein the storage device includes a first memory portion and a second memory portion, and wherein the control unit stores simultaneously detected cardiac depolarizations and corresponding pressure waves in the first memory portion.

34. The implantable medical device of claim 33, wherein the storage unit stores the data stored in the first memory portion and subsequently detected cardiac depolarizations and detected pressure waves in the second memory portion in response to one of the detected cardiac depolarizations and the detected pressure waves.

35. The implantable medical device of claim 34, wherein the detected pressure waves are indicative of one of hemodynamic events of the heart and physical activity of the patient.

36. The implantable medical device of claim 34, further comprising a patient activator, wherein the control unit stores data stored in the first memory portion and subsequently detected cardiac depolarizations and detected pressure waves in the second memory portion in response to a patient activation via the activator.

37. The implantable medical device system of claim 21, wherein the storage device includes a first memory portion and a second memory portion, wherein the control unit stores date corresponding to the detected cardiac depolarizations in the first memory portion, and stores the data in the first memory portion and subsequently detected cardiac depolarizations and corresponding detected pressure waves in the second memory portion in response to a cardiac event being detected.

26. The implantable medical device of 24, wherein the sensor includes a transmitter and a receiver, both the transmitter and the receiver positioned along one of the sensor assembly and the housing portion.

38. An implantable medical device for monitoring heart function of a patient'"'"'s heart from one of a subcutaneous and a submuscular extravascular position, comprising the steps of:

means for detecting cardiac depolarizations from one of a subcutaneous and a submuscular extravascular position and storing data corresponding to the detected cardiac depolarizations in a first memory portion;

means for determining whether a cardiac event is detected in response to the detected depolarizations; and

means for detecting pressure waves corresponding to the heart function from one of a subcutaneous and a submuscular extravascular position storing the data stored in the first memory portion and subsequently detected cardiac depolarizations and detected pressure waves in a second memory portion in response to a cardiac event being detected.