Apparatus and method for arrhythmia induction in arrhythmia control system

• US 5,215,083 A
• Filed: 10/07/1991
• Issued: 06/01/1993
• Est. Priority Date: 10/07/1991
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Telectronics Pacing Systems, Inc (Abbott Laboratories)
• Inventors: Weiss, Steven M., Drane, Geoffrey A.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US07/773,048
• Time in Patent Office: 603 Days
• Field of Search: 128/419 D
• US Class Current: 607/4
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/385 Devices for inducing an abnormal cardiac function, e.g. fibrillation
• CPC Class Codes: A61N 1/3943 for threshold determination

Abstract

An implantable medical device and method for providing therapy to a patient'"'"'s inadequately functioning heart are disclosed. The device and method utilize a defibrillation electrode lead system to deliver defibrillation therapy to the patient'"'"'s heart, and a defibrillator to provide the defibrillation therapy that is delivered by the defibrillation electrode lead system. The defibrillator includes a charge storing circuit for storing an electrical charge therein. Controls are employed for charging the charge storing circuit to an appropriately high energy level for use in defibrillation therapy, in response to a detected tachycardia condition, and for charging the charge storing circuit to an appropriately low energy level for selectively inducing an arrhythmia in the patient'"'"'s heart. Switching circuitry is utilized to couple the charge storing circuit to the defibrillation electrode lead system; and, controls are provided for selectively actuating the switching circuitry to generate a plurality of micro-shocks from the low energy electrical charge in the charge storing circuit and to deliver the micro-shocks to the defibrillation electrode lead system.

Claims

1. An implantable medical device for providing therapy to a patient'"'"'s inadequately functioning heart, comprising:

means for detecting fibrillation;

a defibrillation electrode lead system for delivering defibrillation therapy to the patient'"'"'s heart;

defibrillation circuit means for providing defibrillation therapy to said defibrillation electrode lead system, said defibrillation circuit means including means for storing an electrical charge, first control means coupled to said charge storing means for electrically charging said charge storing means to an appropriately high energy level for use in defibrillation therapy, in response to a detected tachycardia condition, and for electrically charging said charge storing means to an appropriately low energy level for selectively inducing arrhythmia in the patient'"'"'s heart, and switching means for coupling said charge storing means to said defibrillation electrode lead system;

said device further including second control means coupled to said switching means and operative when said first control means has electrically charged said charge storing means to a low energy level for selectively actuating said switching means to generate a plurality of micro-shocks from said low energy electrical charge in said charge storing means and to deliver said micro-shocks to said defibrillation electrode lead system for inducing said arrhythmia in the patient'"'"'s heart.

2. An implantable medical device according to claim 1, further including timing means for controlling said micro-shocks, said timing means controlling intervals between said micro-shocks, pulse widths of said micro-shocks and duration of delivery of said micro-shocks.

3. An implantable medical device according to claim 1 further including means for pacing the heart wherein said device forms part of an implantable pacemaker/defibrillator device.

4. An implantable medical device according to claim 1, further including means for programming said device, and wherein the pulse energy of a said micro-shock is a programmable parameter.

5. An implantable medical device according to claim 1, further including means for programming said device, and wherein the pulse width of a said micro-shock is a programmable parameter.

6. An implantable medical device according to claim 1, further including means for programming said device, and wherein the number of phases of a said micro-shock is a programmable parameter.

7. An implantable medical device according to claim 6, further including means for reversing polarity of selected ones of said micro-shocks and selected phases of said micro-shocks.

8. An implantable medical device according to claim 1, further including means for programming said device, and wherein the pulse frequency of said micro-shocks is a programmable parameter.

9. An implantable medical device according to claim 1, further including means for programming said device, and wherein at least one of (a) the number of micro-shocks delivered and (b) the duration of delivery of said micro-shocks is a programmable parameter.

10. An implantable medical device according to claim 1, further including means for setting the interval between successive micro-shocks, the pulse widths of said micro-shocks, the pulse widths of each phase of each of said micro-shocks, the time delay between said phases of aid micro-shocks, and the duration of each train of micro-shocks based on at least one of (a) a ratio of the cycle length of the patient'"'"'s cardiac rhythm and (b) the amount of haemodynamic compromise extant in the patient'"'"'s heart.

11. An implantable medical device according to claim 1, further including means for increasing the voltage and the amplitude of the energy delivered for the induction of an arrhythmia until capture of the cardiac cells is detected.

12. An implantable medical device according to claim 1, further including a pacing electrode lead system, wherein at least a portion of the energy delivered in the form of said micro-shocks to the patient'"'"'s heart is delivered by said pacing electrode lead system.

13. An implantable medical device according to claim 1, further including a pacing electrode lead system, wherein at least a portion of the number of said micro-shocks delivered to the patient'"'"'s heart is delivered by said pacing electrode lead system.

14. An implantable medical device according to claim 1, further including means for reversing the polarity of at least a portion of the micro-shocks delivered during arrhythmia induction.

15. An implantable medical device according to claim 14, further including means for reversing polarity of each alternate individual micro-shock for the purpose of charge balancing.

16. An implantable medical device according to claim 1, further including means for delivering said micro-shocks in a series of one or more trains.

17. An implantable medical device according to claim 16, further including means for delivering a short run of pacing pulses to entrain the contractions of the heart prior to delivery of said micro-shocks to the patient'"'"'s heart so that the delivery of said train of micro-shocks can be synchronized relative to the patient'"'"'s cardiac cycle.

18. An implantable medical device according to claim 16, further including means for programming said device, means for triggering said micro-shock train, means for providing a post-triggering delay period prior to delivery of a said train, and wherein said post-triggering delay period is a programmable parameter.

19. An implantable medical device according to claim 18, further including means for setting the interval between successive micro-shocks, the pulse widths of said micro-shocks, the pulse widths of each phase of each said micro-shock, the time delay between said phases of said micro-shocks, the delay between the trigger and the commencement of a train of microshocks, the delay between successive trains of micro-shocks, and the duration of each train of micro-shocks based on at least one of (a) a ratio of the cycle length of the patient'"'"'s cardiac rhythm and (b) the amount of haemodynamic comprise extant in the patient'"'"'s heart.

20. An implantable medical device according to claim 16, further including means responsive to a sensing of the patient'"'"'s R-wave for triggering the start of delivery of said series of trains.

21. An implantable medical device according to anyone of claims 16 or 20, further including means for synchronizing the delivery of at least a portion of a said train of micro-shocks to the patient'"'"'s T-wave.

22. An implantable medical device according to any one of claims 16 or 20, further including means for programming said device, and wherein the length of the said series of trains and the widths of said micro-shock pulses are programmable parameters which may be programmed by a physician to suit a patient'"'"'s individual need.

23. An implantable medical device according to any one of claims 16 or 20, further including means for programming said device, and wherein the number of said trains, the number of micro-shocks in a train, and the time delay between successive trains are programmable parameters.

24. A method for inducing fibrillation in and providing defibrillation therapy to a patient'"'"'s inadequately functioning heart, comprising the steps of:

providing an implantable medical device including a fibrillation detection means, a defibrillation electrode lead system for delivering defibrillation therapy to the patient'"'"'s heart and a defibrillation circuit having an electrical charge storing mans therein for providing defibrillation therapy to the defibrillation electrode lead system;

charging said charge storing means to an appropriately high energy level for use in defibrillation therapy in response to a detected tachycardia condition, and to an appropriately low energy level for inducing arrhythmia in the patient'"'"'s heart at selected other times;

generating a plurality of micro-shocks from energy derived from said charge storing means; and

,

delivering at least a portion of said micro-shocks to the patient'"'"'s heart through said defibrillation electrode lead system to induce said arrhythmia therein.

25. A method according to claim 24, wherein said device includes a timing means for controlling said micro-shocks, and said method includes the further steps of controlling the intervals between, the pulse widths of, and the duration of delivery of said micro-shocks.

26. A method according to claim 24, wherein said device is programmable and includes at least one of the following programmable parameters:

the pulse energy of a said micro-shock, the pulse width of a said micro-shock, the number of phases of a said micro-shock, the pulse frequency of said micro-shocks, the number of said micro-shocks, delivered, and the duration of delivery of said micro-shocks; and

wherein said method includes the further step of programming at least one of said programmable parameters.

27. A method according to claim 26, wherein said programming step includes the sub-step of basing the programming setting of said at least one programmable parameter on at least one of (a) a ratio of the cycle length of the patient'"'"'s cardiac rhythm and (b) the amount of haemodynamic compromise extant in the patient'"'"'s heart.

28. A method according to claim 24, including, in the event that capture of cardiac cells is not detected upon delivery of said appropriately low energy level, the further step of increasing the voltage amplitude of the energy delivered for the induction of an arrhythmia until capture of the cardiac cells is detected.

29. A method according to claim 24, wherein said device further includes a pacing electrode lead system, and wherein said micro-shock delivering step includes the substep of delivering at least a portion of the energy of said micro-shocks to the patient'"'"'s heart through said pacing electrode lead system.

30. A method according to claim 24, including the further step of reversing the polarity of at least a portion of the micro-shocks delivered during arrhythmia induction.

31. A method according to claim 30, wherein said polarity reversing step includes the sub-step of reversing the polarity of each alternate individual micro-shock for the purpose of charge balancing.

32. A method according to claim 30, wherein said polarity reversing step includes the sub-step of reversing the polarity of selected portions of individual ones of said micro-shocks.

33. A method according to claim 24, wherein the step of generating said micro-shocks includes the sub-step of generating said micro-shocks in a series of one or more trains, and wherein the step of delivering said micro-shocks includes the sub-step of delivering said micro-shocks in said series of one of more trains.

34. A method according to claim 33, wherein said device forms part of a pacemaker/defibrillator, and wherein said method includes the further step of delivering a short run of pacing pulses to entrain contractions of the heart prior to delivery of said micro-shocks so that the delivery of said train of micro-shocks can be synchronized relative to the patient'"'"'s cardiac cycle.

35. A method according to claim 33, further including the step of triggering the start of delivery of said series of trains in response to a sensing of the patient'"'"'s R-wave.

36. A method according to any one of claims 33 or 35, including the further step of synchronizing the delivery of at least a portion of a said train of micro-shocks to the patient'"'"'s T-wave.

37. A method according to claim 35, including the further step of providing a post-trigger delay period following said triggering step so that a said micro-shock is delivered in synchrony with the patient'"'"'s T-wave.