Hemodynamically responsive system for and method of treating a malfunctioning heart

• US 5,027,816 A
• Filed: 10/02/1989
• Issued: 07/02/1991
• Est. Priority Date: 10/06/1987
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Leonard Bloom
• Inventors: Cohen, Todd J.
• Primary Examiner(s): Jaworski, Francis
• Assistant Examiner(s): MANUEL, GEORGE C
• Application Number:
  US07/416,276
• Time in Patent Office: 638 Days
• Field of Search: 128/419 P, 128/419 D, 128/419 PG
• US Class Current: 607/4
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 1/3918 characterised by shock pathway, e.g. by electrode configuration
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

A system for and method of treating a malfunctioning heart is based on hemodynamics, the pressure at a site in a patient'"'"'s circulatory system being sensed. A signal is developed representative of short term mean arterial pressure (MAP) or right ventricular systolic pressure (RVSP), or right ventricular pulse pressure (RVPP). The rate of change and direction of the rate of change is determined and, if the rate of change in a given direction exceeds a predetermined amount, an indication of possible hemodynamic compromise, cardioversion/defibrillation is effected.

Claims

1. In a cardioverting/defibrillation system for treating a malfunctioning heart of the type which includes storage means for storing electrical energy, electrode means for electrically coupling the storage means to the heart, sensing means for sensing pressure at least one site within a circulatory system of an individual, means responsive to output from the sensing means for developing a first signal representing current level of the pressure over a period of predetermined duration, means responsive to the first signal for determining rate of change of the first signal and algebraic sign of the rate of change, and means responsive to output from the means responsive to the first signal for charging and enabling discharge of the electrical energy stored by the storage means across the electrode means upon the rate of change of the first signal exceeding a predetermined amount and being of a given algebraic signal.

2. The system according to claim 1, wherein the means for developing a first signal representative of current level of the pressure comprise means providing a signal representative of current mean arterial pressure within the circulatory system of an individual.

3. The system according to claim 1, wherein the means for developing a first signal representative of current level of the pressure comprises means providing a signal representative of current right ventricular systolic pressure.

4. The system according to claim 1, wherein the means for developing a first signal representative of current level of the pressure comprise means providing a signal representing current right ventricular pulse pressure.

5. The system according to claim 1, wherein the means for developing a first signal representative of current level of the pressure comprises means for providing a signal representative of current systolic pressure at the site within the circulatory system of an individual.

6. The system according to claim 1, wherein the means for developing a first signal representation of current level of the pressure comprises means for providing a signal representative of pulse pressure at the site within the circulatory system of an individual.

7. The system according to claim 1, wherein the means responsive comprises a microprocessor for developing a control signal to control the means for charging and enabling discharge of the electrical energy stored by the storage means.

8. The system according to claim 1, including electrical means for sensing heart rate and producing a distinctive control signal upon the heart rate exceeding a predetermined rate, controllable antitachycardia pacemaking means for supplying pacing signals to the heart, controllable cardioverting/defibrillating means, including the storage means for storing electrical energy, control circuit means responsive to the distinctive control signal and to an output from the means for charging and enabling discharge to enable the antitachycardia pacemaking means in response to presence of the distinctive control signal and contemporaneous absence of the output and for enabling said cardioverting/defibrillating means in response to contemporaneous presence of both the distinctive control signal and the output.

9. The system according to claim 8, including means responsive to output from said electrical means for sensing heart rate for developing a discharge-synchronizing signal synchronized to an R-wave, and the means for discharging electrical energy across the electrode means and into the heart includes means for synchronizing the discharge with the discharge-synchronizing signal to effect cardioversion.

10. The system according to claim 9, wherein the means for discharging electrical energy across the electrode means and into the heart effects discharge on a nonsynchronized basis, in the absence of the discharge-synchronizing signal, to effect defibrillation.

11. The system according to claim 1, including means for discharging electrical energy across said electrode means and into the heart effects discharge on a nonsynchronized basis to effect defibrillation.

12. A method of treating a malfunctioning heart comprising providing a representation of a pressure parameter at a least, one site in a circulatory system for an individual determining current level of the pressure parameter over a period of given duration, determining rate of change and algebraic sign thereof in the current level, and delivering cardioverting/defibrillating electrical energy to the heart whenever the rate of change exceeds a predetermined amount and the sign thereof is a given algebraic sign.

13. The method according to claim 12, wherein the step of determining is constituted by determining pulse pressure at the site in the circulatory system of an individual.

14. The method according to claim 12, wherein the step of determining is constituted by determining right ventricular pulse pressure.

15. The method according to claim 12, wherein the step of determining is constituted by determining systolic pressure at the site in the circulatory system of an individual.

16. The method according to claim 12, wherein the step of determining is constituted by determining right ventricular systolic pressure.

17. The method according to claim 12, wherein the step of determining is constituted by determining mean arterial pressure at the site in the circulatory system of an individual.

18. The method according to claim 12, including sensing heart rate, the step of delivering cardioverting/defibrillating electrical energy being taken upon the heart rate exceeding a given rate and the rate of change in the current level exceeding the predetermined amount and being of the given algebraic sign.

19. A cardioverting/defibrillating system for treating a malfunctioning heart comprising means for determining rate of change and algebraic sign thereof in at least one current pressure parameter at a site in a circulatory system of an individual and means responsive to output from the determining means for providing an output to overcome the malfunction upon the rate of change of the pressure parameter exceeding a predetermined amount and the sign thereof being a given algebraic sign.

20. In a cardioverting/defibrillating system for treating a malfunctioning heart of the type which includes storage means for storing electrical energy to be used to effect cardioversion/defibrillation, electrode means for electrically coupling the storage means to the heart, sensing means for sensing at least one hemodynamic parameter at a least one site within a circulatory system of an individual, means responsive to output from the sensing means for developing a first signal representing current level of the hemodynamic parameter over a period of predetermined duration, means responsive to the first signal for determining rate of change of the first signal and algebraic sign of the rate of change, and means responsive to output from the means responsive to the first signal for charging and enabling discharge of the electrical energy stored by the storage means across the electrode means to effect cardioversion/defibrillation upon the rate of change of the first signal exceeding a predetermined amount and being of a given algebraic sign.

21. The system according to claim 20, wherein the means for developing a first signal representative of current level of the hemodynamic parameter comprises means providing a signal representative of current means pressure at the site within the circulatory system of an individual.

22. The system according to claim 20, wherein the means for developing a first signal representative of current level of the hemodynamic parameter comprises means providing a signal representative of current systolic pressure at the site within the circulatory system of an individual.

23. The system according to claim 20, wherein the means for developing a first signal representative of current level of the hemodynamic parameter comprises means providing a signal representing current pulse pressure at the site within the circulatory system of an individual.

24. The system according to claim 20, wherein the means for developing a first signal representative of current level of the hemodynamic parameter comprises means providing a signal representative of current pressure at the site within the circulatory system of an individual.

25. The system according to claim 20, wherein the means responsive comprises a microprocessor for developing a control signal to control the means for charging and enabling discharge of the electrical energy stored by the storage means.

26. The system according to claim 20, including electrical means for sensing heart rate and producing a distinctive control signal upon the heart rate exceeding a predetermined rate, controllable antitachycardia pacemaking means for supplying pacing signals to the heart, controllable cardioverting/defibrillating means, including the storage means for storing electrical energy, control circuit means responsive to the distinctive control signal and to an output from the means for charging and enabling discharge to enable the antitachycardia pacemaking means in response to presence of the distinctive control signal and contemporaneous absence of the output and for enabling said cardioverting/defibrillating means in response to contemporaneous presence of both the distinctive control signal and the output.

27. The system according to claim 26, including means responsive to output form said electrical means for sensing heart rate for developing a discharge-synchronizing signal synchronized to an R-wave, and the means for discharging electrical energy across the electrode means and into the heart includes means for synchronizing the discharge with the discharge-synchronizing signal to effect cardioversion.

28. The system according to claim 27, wherein the means for discharging electrical energy across the electrode means and into the heart effects discharge on a nonsynchronized basis, in the absence of the discharge-synchronizing signal, to effect defibrillation.

29. The system according to claim 20, including means for discharging electrical energy across said electrode means and into the heart effects discharge on a nonsynchronized basis to effect defibrillation.

30. A method of cardioverting/defibrillating a malfunctioning heart comprising providing a representation of a hemodynamic parameter at least one site in a circulatory system of an individual, determining current level of the parameter over a period of given duration, determining rate of change of the current level and algebraic sign thereof, and delivering stored cardioverting/defibrillating electrical energy to the heart whenever the rate of change exceeds a predetermined amount and is of a given algebraic sign.

31. The method according to claim 30, wherein the step of determining is constituted by determining pulse pressure at the site in the circulatory system of an individual.

32. The method according to claim 30, wherein the step of determining is constituted by determining systolic pressure at the site in the circulatory system of an individual.

33. The method according to claim 30, wherein the step of determining is constituted by determining means pressure at the site in the circulatory system of an individual.

34. The method according to claim 30, including sensing heart rate, the step of delivering cardioverting/defibrillating electrical energy being taken upon the heart rate exceeding a given rate and the rate of change in the current level of the hemodynamic parameter exceeds the predetermined amount and is of the given sign.