Implantable responsive system for sensing and treating acute myocardial infarction and for treating stroke

• US 6,468,263 B1
• Filed: 05/21/2001
• Issued: 10/22/2002
• Est. Priority Date: 05/21/2001
• Status: Expired due to Term

• Current Assignee: Angel Medical Systems, Inc.
• Original Assignee: Angel Medical Systems, Inc.
• Inventors: Fischell, David R., Fischell, Robert E., Fischell, Tim A.
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Sirmons, Kevin C.
• Application Number:
  US09/860,693
• Time in Patent Office: 519 Days
• Field of Search: 604/890.1, 604/65, 604/66, 604/891.1, 607/30, 607/5, 607/9, 607/63, 607/2.4, 607/25, 607/32, 607/60, 607/62, 600/341, 600/517, 600/523
• US Class Current: 604/890.1
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/358 Detecting ST segments
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61N 1/3629 in combination with non-electric therapy

Abstract

Disclosed is a completely implantable system that can detect the occurrence of a myocardial infarction, i.e., a heart attack, and automatically inject a thrombolytic and/or anti-thrombogenic agent into the bloodstream to promptly dissolve the thrombus that caused the myocardial infarction and prevent the formation of additional thrombi. It is well known that a myocardial infarction can be detected from a patient'"'"'s electrocardiogram by noting an ST segment voltage deviation. Upon detection of a myocardial infarction, an ST segment deviation electronic detection circuit within the implanted device can produce an output signal that can cause a thrombolytic and/or anti-thrombogenic agent contained within an implanted, pressurized reservoir to immediately and automatically release medications into the patient'"'"'s bloodstream. A patient warning system is also provided by an audio alarm or an electrical tickle within the human body indicating that a myocardial infarction has been detected. An externally located part of the system, in the form of a patient operated initiator, can be used to trigger the release of medication as soon as a first sign of a stroke has been detected in order to prevent damage to brain tissue that would be caused by that stroke. Thus the system can be used to prevent trissue damage from either a myocardial infarction or a stroke. The implanted system can also send a radio message to an externally located receiver that automatically dials an emergency rescue team to take the patient to a hospital for continuing treatment of a myocardial infarction or a stroke.

Claims

1. A medication release system for the treatment of heart attack and/or stroke of a human subject, the medication release system being the combination of an automatic treatment for myocardial infarction and the manual initiation of a treatment for a stroke in response to detection of the early symptoms of such a stroke, the medication release system comprising:

a sensor having an output electrical signal, the sensor being adapted to detect a signal from within the human subject that is indicative of the onset of myocardial infarction;

a patient operated initiator that is adapted to be manually actuated when at least one early symptom of a stroke is detected; and

an implanted medication release device that contains electrical circuitry means that is electrically connected to the sensor, the electrical circuitry means being adapted to provide a triggering signal when the output electrical signal from the sensor indicates the occurrence of a myocardial infarction, the medication release device also having at least one medication reservoir for storing a medication and also having a medication releasing means for causing that medication to be released into the bloodstream of the human subject when the triggering signal from the electrical circuitry means indicates that a myocardial infarction is occurring and the electrical circuitry means also being adapted to trigger the release of medication from the medication releasing means when the patient operated initiator is manually actuated.

2. The medication release system of claim 1 wherein the sensor consists of at least two electrodes that are adapted to sense an electrogram from within the human subject.

3. The medication release system of claim 2 wherein at least one electrode is placed inside the right ventricle at or near the apex of the heart.

4. The medication release system of claim 2 wherein at least one electrode is placed in the right atrium.

5. The medication release system of claim 2 wherein at least one electrode is placed in the superior vena cava.

6. The medication release system of claim 2 wherein the medication release device is contained within a metal case and the system includes at least one active electrode and the metal case acts as a second electrode which is an indifferent electrode.

7. The medication release system of claim 1 wherein the sensor includes at least one subcutaneous electrode that is placed outside of the circulatory system of the human subject, the subcutaneous electrode being placed subcutaneously under the skin of the human subject.

8. The medication release system of claim 1 wherein the medication reservoir is formed from a metal bellows.

9. The medication release system of claim 1 wherein the medication in at least one medication reservoir is a thrombolytic agent.

10. The medication release system of claim 9 wherein the thrombolytic agent is streptokinase.

11. The medication release system of claim 9 wherein the thrombolytic agent is urokinase.

12. The medication release system of claim 9 wherein the thrombolytic agent is tissue plasminogen activator.

13. The medication release system of claim 9 wherein the thrombolytic agent is a mixture of two or more medications.

14. The medication release system of claim 1 wherein the medication is an anti-thrombogenic medication.

15. The medication release system of claim 14 wherein the medication is ReoPro.

16. The medication release system of claim 14 wherein the medication is heparin.

17. The medication release system of claim 1 wherein the medication within the medication release device is in the form of a powder.

18. The medication release system of claim 17 wherein the powder is a thrombolytic agent.

19. The medication release system of claim 18 wherein the thrombolytic agent is streptokinase powder.

20. The medication release system of claim 1 wherein there is exactly one medication reservoir.

21. The medication release system of claim 1 wherein there are exactly two medication reservoirs.

22. The medication release system of claim 1 wherein there are exactly three medication reservoirs.

23. The medication release system of claim 1 wherein the medication releasing means is a valve that is opened after the sensor senses the occurrence of a myocardial infarction or when the patient operated initiator is manually activated.

24. The medication release system of claim 1 wherein the medication releasing means is a valve operated by means of changing the polarity of a chargeable magnet.

25. The medication release system of claim 1 wherein the medication releasing means is a conventional drug pump.

26. The medication release system of claim 1 wherein the electrical circuitry means includes the capability for recording the electrogram and playing back the electrogram at a later time.

27. The medication release system of claim 1 wherein the electrical circuitry means includes a command receiver for receiving programming commands by radio transmission from a physician'"'"'s programmer that is located externally from the human subject, the programming commands being capable of changing the operating modes of the medication release system.

28. The medication release system of claim 1 wherein the electrical circuitry means includes a radio transmitter for transmitting information from the implanted medication release system to a physician'"'"'s programmer.

29. The medication release system of claim 1 wherein the electrical circuitry means includes a radio transmitter for transmitting information to a receiver that is located within 200 meters of the human subject, the receiver being adapted to cause an alarm means to inform the human subject that his implanted medication release system has sensed the occurrence of a myocardial infarction.

30. The medication release system of claim 1 wherein the electrical circuitry means includes a radio transmitter for transmitting information to a receiver that is located within 200 meters of the human subject, the receiver being adapted to send a message to a medical rescue facility that the medication release system within the human subject has sensed the occurrence of a myocardial infarction or has triggered the release of medication by manual actuation of the patient operated initiator.

31. The medication release system of claim 30 wherein the message received by the medical rescue facility includes the electrogram of the human subject.

32. The medication release system of claim 30 wherein the message received by the medical rescue service includes at least one of the following group of data:

the medical history of the human subject, the address of the human subject and the directions to the location of the human subject.

33. The medication release system of claim 1 further comprising defibrillation means operated from automatic defibrillation circuitry implanted within the human subject.

34. The medication release system of claim 1 further comprising implantable heart pacemaker circuitry for pacing the heart of the human subject by means of electrical pulses.

35. The medication release system of claim 1 wherein the electrical circuitry means includes the capability for alarming the human subject that a myocardial infarction is occurring by causing an audio sound to be produced that can be heard by the human subject.

36. The medication release system of claim 1 wherein the electrical circuitry means includes the capability of alarming the human subject that a myocardial infarction is occurring by means of a subcutaneous electrical tickle that can be detected by the human subject.

37. The medication release system of claim 1 wherein the patient operated initiator is located external to the human subject, the patient operated initiator being adapted to send a radio signal to a command receiver within the medication release device, the radio signal being adapted to cause the release of medication from the implanted medication release device.

38. The medication release system of claim 37 wherein the patient operated initiator is adapted to be activated by the human subject or by a patient caregiver of the human subject when at least one symptom of a stroke is detected.

39. The medication release system of claim 1 wherein the patient operated initiator is activated by a predetermined sequence of actuation on-times and off-times, which predetermined sequence is recognized by the electronic circuitry means of the implanted portion of the medication release system.