Implantable electronic system with acute myocardial infarction detection and patient warning capabilities

• US 6,272,379 B1
• Filed: 03/17/1999
• Issued: 08/07/2001
• Est. Priority Date: 03/17/1999
• Status: Expired due to Term

• Current Assignee: Angel Medical Systems, Inc.
• Original Assignee: Cathco, Inc.
• Inventors: Fischell, David R., Fischell, Robert E., Fischell, Tim A.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US09/271,219
• Time in Patent Office: 874 Days
• Field of Search: 600/509, 600/515, 600/517, 600/523, 607/2, 607/3, 607/4, 607/5, 607/9, 607/25, 607/30, 607/32, 607/60, 607/62
• US Class Current: 607/5
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting

Abstract

Disclosed is a system for detecting a myocardial infarction (i.e., a heart attack) at the earliest possible time and promptly warning the patient that he should immediately seek medical care. Specifically, a first embodiment of the present invention has an implantable electronic system that can sense a change in the patient'"'"'s electrogram that is indicative of a myocardial infarction. If a myocardial infarction is sensed, the device would then cause an implantable or externally located alarm means such as an audio sound to be actuated to warn the patient of his condition. The patient could then promptly seek medical care, for example, at a hospital emergency room. Having been trained to recognize such an alarm, most patient would neither fail to recognize such an indication of a myocardial infarction nor would they ignore such an alarm signal if it were to occur. Since an implantable heart pacemaker or defibrillator already has within its structure many of the elements required for the device to recognize a myocardial infarction, it would be expeditious to add a capability to these existing devices to detect a myocardial infarction and provide an implantable or external alarm means to inform the patient to take appropriate action.

Claims

1. A cardiosaver system for indicating to a human subject that a myocardial infarction is occurring, the system comprising:

an implantable sensor for detecting the occurrence of a myocardial infarction, the implantable sensor being adapted for implantation within the human subject, the sensor also having an output electrical signal that is the electrogram that is generated by the heart of the human subject;

an implanted alarm means for informing the human subject that a myocardial infarction is occurring, the implanted alarm means being adapted for implantation within the human subject;

the implantable sensor and the implanted alarm means both being parts of a cardiosaver that is adapted for implantation into the human subject; and

the cardiosaver further comprising a radio transmitter that is adapted to transmit a radio signal to a close proximity alarm system which includes an external alarm means, the cardiosaver being adapted to simultaneously trigger the implanted alarm means within the human subject and activate the external alarm means within the close proximity alarm system when the cardsiosaver detects that the human subject is having a myocardial infarction.

2. The cardiosaver system of claim 1 wherein the implantable sensor is two or more electrodes.

3. The cardiosaver system of claim 2 wherein one of the electrodes is an active electrode and the cardiosaver further includes an implanted electronics module that has a metal case that acts as an indifferent electrode.

4. The cardiosaver system of claim 3 wherein the electronics module includes electronics circuitry that is adapted to detect the occurrence of a myocardial infarction from a deviation of the sensor'"'"'s output electrical signal, the deviation being a change from the sensor'"'"'s output signal when there is no myocardial infarction occurring.

5. The cardiosaver system of claim 4 wherein the'"'"'electronics circuitry within the electronics module includes a detector for detecting a ST segment deviation of the electrogram as an indication of myocardial infarction.

6. The cardiosaver system of claim 4 wherein the electronics circuitry within the electronics module includes means for recording the electrogram from the sensor, the means for recording the electrogram including a digital memory adapted to retain the electrogram for playback at a later time.

7. The cardiosaver system of claim 6 wherein the close proximity alarm system includes a telephone communication link that is adapted to automatically call an emergency medical services organization by means of the telephone link when the implanted cardiosaver detects the occurrence of a myocardial infarction in the human subject.

8. The cardiosaver system of claim 7 wherein the close proximity alarm system also includes means for receiving the electrogram as stored in the digital memory of the means for recording the electrogram of the implanted cardiosaver, the close proximity alarm system also including means for receiving the real time electrogram from the cardiosaver, the close proximity alarm system further including means for transmitting the stored electrogram and real time electrogram over the telephone link to the emergency medical facility.

9. The cardiosaver system of claim 1 wherein the implanted alarm means of the cardiosaver system further comprises means for producing a subcutaneous electrical tickle.

10. The cardiosaver system of claim 9 further comprising a physician'"'"'s programmer located externally to the human subject, the physician'"'"'s programmer including means for adjusting the intensity of the subcutaneous electrical tickle.

11. The cardiosaver system of claim 1 wherein the implanted alarm means of the cardiosaver system further comprises means for producing a sound that is an audio alarm that is an indication to the human subject that a myocardial infarction is occurring.

12. The cardiosaver system of claim 11 further comprising a physician'"'"'s programmer located externally to the human subject, the physician'"'"'s programmer including means for adjusting the intensity of the sound from the audio alarm.

13. The cardiosaver system of claim 1 wherein the close proximity alarm system includes memory storage means for storing a preset audio warning signal, the preset audio warning signal being produced by the close proximity alarm system when the implanted electronics module detects the occurrence of a myocardial infarction.

14. The cardiosaver system of claim 13 wherein the preset audio warning signal includes a description of at least one medication that is to be taken by the human subject.

15. The cardiosaver system of claim 13 wherein the preset audio warning signal includes instructions to proceed immediately to an emergency medical facility.

16. The cardiosaver system of claim 13 wherein the preset audio warning signal includes the statement that an ambulance is on its way to bring the patient to an emergency medical facility.

17. The cardiosaver system of claim 1 further comprising a radio receiver and command system as part of the implanted cardiosaver and a physician'"'"'s programmer located externally from the human subject, the physician'"'"'s programmer being adapted to receive radio signals from the implanted cardiosaver and to provide programming signals to be received by the receiver and command system of the implanted cardiosaver.

18. The cardiosaver system of claim 17 wherein the physician'"'"'s programmer is adapted to display both real time and stored electrogram data that is sent by the radio signal from the implanted electronics module.

19. The cardiosaver system of claim 17 wherein the physician'"'"'s programmer is adapted to receive telemetry data from the implanted electronics module and visually display those data.

20. The cardiosaver system of claim 1 wherein the external alarm means is a transportable alarm means that is adapted to be carried by the human subject, the transportable alarm means including a radio receiver and an audio alarm means, the transportable alarm means also being adapted to receive the radio signal from the implanted cardiosaver thereby informing the human subject by means of the audio alarm means that a myocardial infarction is occurring.

21. The cardiosaver system of claim 20 wherein the audio alarm means of the transportable alarm means includes a preset recording of a human voice.

22. The cardiosaver system of claim 1 further comprising an implanted electronics module that is adapted to receive command programming instructions from an externally located physician'"'"'s programmer.

23. The cardiosaver system of claim 1 further comprising a physician'"'"'s programmer and the implanted cardiosaver being adapted to be programmed by the physician'"'"'s programmer to a specific voltage threshold of the electrogram above which voltage the cardiosaver will cause the implanted alarm means and the external alarm means to be actuated thereby indicating to the human subject that a myocardial infarction has been detected.

24. A system adapted for implantation within a human subject for the treatment of disorders of the heart, the system comprising an implanted electronic device for detecting and treating disorders of the heart of the human subjects, the implanted electronic device being a combination of a heart pacemaker and a cardiosaver, the heart pacemaker having heart pacemaker electronics circuitry adapted for providing electrical pulses to pace the heart and the cardiosaver having cardiosaver electronics circuitry adapted for detecting the occurrence of a myocardial infarction, the cardiosaver also having alarm means for alarming the human subject when a myocardial infarction is occurring.

25. The implanted system of claim 24 wherein the heart pacemaker electronics circuitry and the cardiosaver electronics circuitry are both contained within a single case.

26. The implanted system of claim 24 wherein the heart pacemaker electronics circuitry is contained within a first case and the cardiosaver electronics circuitry is contained within a second case that is separate from the first case.

27. The implanted system of claim 24 wherein the alarm means is an implanted alarm means that is an audio alarm implanted within the human subject.

28. The implanted system of claim 24 wherein the alarm means is an implanted alarm means that is an electrical tickle device implanted within the human subject, the electrical tickle device being adapted to warn the human subject that a myocardial infarction is occurring by means of a subcutaneous electrical stimulation signal.

29. The implanted system of claim 24 further comprising an external alarm means that is operable within 200 meters of where the patient is positioned.

30. The implanted system of claim 24 further comprising an external alarm means that is transportable and adapted to be carried by the human subject.

31. A system adapted for implantation within a human subject for the treatment of disorders of the heart, the system comprising an implanted electronic device for detecting and treating disorders of the heart of the human subject, the implanted electronic device being a combination of an implantable automatic heart defibrillator and a cardiosaver, the heart defibrillator having heart defibrillator electronics circuitry adapted for automatically providing a defibrillation electrical pulse to the heart when ventricular fibrillation is detected by the defibrillator electronics circuitry and the cardiosaver having cardiosaver electronics circuitry adapted for detecting the occurrence of a myocardial infarction, the cardiosaver also having alarm means for alarming the human subject when a myocardial infarction is occurring.

32. The system of claim 31 further comprising a heart pacemaker having heart pacemaker electronics adapted for providing electrical pulses to pace the heart.

33. The implanted system of claim 31 wherein the implantable defibrillator electronics circuitry and the cardiosaver electronics circuitry are both contained within a single case.

34. The implanted system of claim 31 wherein the implantable defibrillator electronics circuitry is contained within a first case and the cardiosaver electronics circuitry is contained within a second case that is separate from the first case.

35. The implanted system of claim 31 wherein the alarm means is an implanted alarm means for providing an audio alarm from within the human subject when a myocardial infarction is detected by the cardiosaver.

36. The implanted system of claim 31 wherein the alarm means is an implanted alarm means that is an electrical tickle device adapted for implantation within the human subject, the electrical tickle device being adapted to warn the human subject that a myocardial infarction is occurring by means of a subcutaneous electrical stimulation signal.

37. The implanted system of claim 31 further comprising an external alarm means that is operable within 200 meters of where the patient is positioned.

38. The implanted system of claim 31 further comprising an external alarm means that is readily transportable and adapted to be carried by the human subject.

39. A method to inform certain human subjects that a myocardial infarction is occurring, the method comprising the following steps:

(a) test the human subject to determine if that subject has a fasting blood sugar that is greater than 140 mg/dl;

(b) determine if the human subject has any one or more of the following conditions;

a prior heart attack, a family history of heart disease, atherosclerosis, previous coronary bypass surgery or hypercholesterolemia;

(c) if the fasting blood sugar is greater than 140 mg/dl, and at least one of the conditions listed in (b) above exists, then implant within the human subject a cardiosaver system that is adapted to detect the occurrence of a myocardial infarction using an implanted sensor and electronics module which together are adapted to trigger an alarm that informs the human subject that a myocardial infarction is occurring.