Electrical cardiac assist for an implantable syncope monitor

• US 6,351,670 B1
• Filed: 09/08/1999
• Issued: 02/26/2002
• Est. Priority Date: 05/31/1994
• Status: Expired due to Fees

• Current Assignee: Galvani, Ltd.
• Original Assignee: Galvani, Ltd.
• Inventors: Kroll, Kai
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US09/392,233
• Time in Patent Office: 902 Days
• Field of Search: 607/5
• US Class Current: 607/5
• CPC Class Codes: A61N 1/3625 External stimulators
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/3918 characterised by shock pathway, e.g. by electrode configuration

Abstract

A method and apparatus for monitoring syncope, and having available for use an electrical cardiac output forcing (ECOF) back up. An implantable device, including an ECOF back up, for recording the electrical activity within a human heart is provided. The device includes a power supply for operating the device and for providing the necessary output forcing signals. A monitoring or detection device is provided connected to the power supply. Electrodes are provided to electrically connect the power supply and the detection device to a patient'"'"'s heart. A memory device is also provided connected to the detection device for recording electrical activity and/or blood pressure data of the patient'"'"'s heart. The memory device may be comprised of a short term loop buffer for continuously recording the electrical data from the patient'"'"'s heart and a long term storage buffer. The short term loop may be of a desired size, for example, capable of storing from 1-30 minutes of data before overriding occurs. Upon the occurrence of a predetermined event, for example, a bout of syncope, the data in the short term loop buffer is transferred to the long term storage buffer. An output control circuit is also provided which is connected to the detection device and to the power supply and to the electrodes. Upon the occurrence of a second predetermined event, such as fibrillation of the heart, the output control circuit causes the delivery of an electrical cardiac output forcing signal to the patient'"'"'s heart.

Claims

1. An implantable device for recording electrical activity within a heart wherein the device includes electrical cardiac output forcing back up, the device comprising:

power supply means;

detection means connected to the power supply means;

means to communicatively connect the power supply means and the detection means to a patient'"'"'s heart;

memory means operably connected to the detection means for recording electrical activity data of the patient'"'"'s heart upon the occurrence of a first predetermined condition; and

output control means connected to the detection means and to the power supply means and to the means to communicatively connect for delivering an electrical cardiac output forcing signal to the patient'"'"'s heart upon the occurrence of a second predetermined condition.

2. The device as in claim 1, wherein the detection means comprises an ECG sensor.

3. The device as in claim 1, wherein the means to communicatively connect comprises at least one electrode.

4. The device as in claim 3, wherein the at least one electrode is insertable into the patient'"'"'s heart.

5. The device as in claim 1, wherein the memory means comprises first and second memory buffers.

6. The device as in claim 5, wherein the first memory buffer is a short term revolving buffer.

7. The device as in claim 6, wherein the short term revolving buffer records less than 30 minutes of electrical activity data.

8. The device as in claim 5, wherein the second memory means buffer is a long term buffer operably coupled to the short term buffer.

9. The device as in claim 8, wherein the long term buffer records more than 30 minutes of electrical activity data transferred to it from the short term buffer.

10. The device as in claim 8, further comprising downloading means for downloading data in the long term buffer to an external device.

11. The device as in claim 1, wherein the first predetermined condition is the detection of syncope.

12. The device as in claim 1, wherein the second predetermined condition is ventricular fibrillation.

13. The device as in claim 1, wherein the electrical cardiac output forcing signal has a voltage between 25 and 200 volts and a current greater than 250 mA.

17. The device as in claim 1, wherein the memory means comprises first and second memory buffers.

18. The device as in claim 17, wherein the first memory buffer is a loop buffer for continuously storing the electrical activity data in a revolving loop.

19. The devices as in claim 18, wherein the loop buffer records less than 30 minutes of electrical activity data before overwriting occurs.

20. The device as in claim 18, further comprising data transferring means for transferring the recorded data from the first memory means to the second memory means upon the occurrence of a predetermined condition.

21. The device as in claim 20, wherein the predetermined condition is the detection of syncope.

22. The device as in claim 20, wherein the predetermined condition is the detection of a magnetic field.

23. The device as in claim 20, wherein the second memory means is capable of recording more than 30 minutes of electrical activity data received from the loop buffer.

36. The device as in claim 1, wherein the detection means comprises a blood pressure monitor.

14. An implantable device for recording electrical activity within a heart wherein the device includes electrical cardiac output forcing back up, the device comprising:

power supply means;

detection means connected to the power supply means;

means to communicatively connect the power supply means and the detection means to a patient'"'"'s heart;

memory means operably connected to the detection means for continuously recording electrical activity data of the patient'"'"'s heart; and

output control means connected to the detection means and to the power supply means and to the means to communicatively connect for delivering an electrical cardiac output forcing signal to the patient'"'"'s heart upon the detection of fibrillation.

15. The device as in claim 14, wherein the detection means comprises ECG sensor.

16. The device as in claim 14, wherein the means to communicatively connect comprises at least one electrode.

24. The device as in claim 14, wherein the electrical cardiac output forcing signal has a voltage between 25 and 200 volts and a current greater than 250 mA.

25. An implantable cardiac device comprising:

an ECG detector having a continuous ECG recorder; and

an electrical cardiac output forcing stimulator connected to the ECG detector actuable upon the occurrence of an abnormal sinus rhythm.

26. An implantable cardiac device comprising:

an ECG detector having an ECG recorder actuable upon the occurrence of a first predetermined cardiac event; and

an electrical cardiac output forcing stimulator connected to the ECG detector actuable upon the occurrence of a second predetermined cardiac event.

27. A method of monitoring syncope in an implantable device having ECOF back up through electrodes connected to a power source, the method including the steps of:

monitoring a patient'"'"'s heart data;

continuously recording the monitored data in a revolving buffer;

transferring the recorded data from the revolving buffer to a long term storage buffer upon the occurrence of a first event; and

discharging energy from the power source across the electrodes for electrical cardiac output forcing of the heart upon the occurrence of a second event.

28. The method as in claim 27, wherein the first event is the onset of syncope.

29. The method as in claim 27, wherein the second event is the onset of fibrillation.

30. The method of claim 27, further including the step of downloading the stored data in the long term storage buffer to an external device upon a third event.

31. The method as in claim 27, wherein the first event is the detection of a magnetic field.

32. The method as in claim 30, wherein the third event is the detection of a magnetic field.

33. The method as in claim 27, wherein the step of discharging is accomplished with an energy source having a voltage between 25 and 200 volts and a current greater than 250 mA.

34. A method for maintaining cardiac equilibrium comprising;

internally monitoring a cardiac rhythm;

recording the cardiac rhythm upon the occurrence of a first predetermined cardiac event; and

electrically forcing cardiac output upon the occurrence of a second predetermined cardiac event.

35. A method for maintaining cardiac equilibrium comprising:

internally monitoring and recording cardiac rhythm continuously; and

electrically forcing cardiac output upon the occurrence of an abnormal sinus rhythm.

37. The method of claim 35, wherein the step of electrically forcing cardiac output is initiated by a voluntary patient prompt.