Hemodynamically responsive system for and method of treating a malfunctioning heart

• US 5,085,213 A
• Filed: 06/01/1990
• Issued: 02/04/1992
• Est. Priority Date: 06/01/1990
• 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:
  US07/531,866
• Time in Patent Office: 613 Days
• Field of Search: 128/419 PG, 128/419 D
• US Class Current: 607/4
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

A system for a method of treating a malfunctioning heart is based on hemodynamics, the pressure in the right side of a patient'"'"'s circulatory system being sensed. A first signal is developed representative of mean right atrial pressure (MRAP) and a second signal is developed representing right ventricular systolic pressure (RVSP). When the MRAP increases by at least a predetermined amount and the RVSP decreases at least a given amount, the combination being an indication of hemodynamic compromise, cardioversion/defibrillation is effected. In these cases, a heart rate criterion, for example a rate over 150 bpm, may also have to be met before cardioverting/defibrillation is initiated. Fixed or variable baselines against which the changes in pressure are measured may be provided.

Claims

1. In a 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, determining means for determining right atrial pressure or central venous pressure and right ventricular pressure, means responsive to an output from the determining means for providing a first signal representative of an increase of at least a predetermined amount in the right atrial pressure or central venous pressure, means responsive to an output from the determining means for developing a second signal representative of a decrease of at least a given amount in right ventricular pressure, and means responsive to the first signal and the second signal for charging and enabling discharge of the electrical energy stored by the storage means across the electrode means upon presence of both the first and the second signals.

2. The system according to claim 1, wherein said determining means comprises means for determining mean right atrial pressure or mean central venous pressure and right ventricular systolic pressure, wherein said means responsive to output for providing a first signal comprises means responsive to output from the determining means for providing the first signal representative of an increase of at least a predetermined amount in mean right atrial pressure or mean central venous pressure, wherein said means responsive to output for providing a second signal comprises means responsive to output from the determining means for providing the first signal representative of a decrease of at least a given amount in right ventricular systolic pressure.

3. The system according to claim 2, including means for establishing respective fixed signal baseline representations of respective mean right atrial pressure or mean central venous pressure and right ventricular systolic pressure.

4. The system according to claim 2, including means for establishing respective variable signal baseline representations of respective mean right atrial pressure or mean central venous pressure determined over a predetermined period of time and right ventricular systolic pressure determined over a given period of time.

5. The system according to claim 1, wherein the means responsive to the first signal and the second signal includes 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.

6. 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, and wherein the means responsive to the first signal and to the second signal enables discharge of the storage means upon contemporary presence of the first signal, the second signal and the control signal.

7. The system according to claim 6, including antitachycardia pacemaking means responsive to presence of the distinctive control signal and contemporaneous absence of at least one of the first signal and the second signal for delivering pacing signals to the heart whereby tachycardia may be overcome.

8. The system according to claim 6, 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 wherein 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.

9. The system according to claim 8, 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 synchronization signal, to effect defibrillation.

10. 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.

11. The system according to claim 1, including means for establishing respective fixed signal baseline representations of respective right atrial pressure or central venous pressure and right ventricular pressure.

12. The system according to claim 1, including means for establishing respective variable signal baseline representations of respective right atrial pressure or central venous pressure determined over a predetermined period of time and right ventricular pressure determined over a given period of time.

13. In a 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, determining means for determining a first pressure parameter at one site in a circulatory system and a second pressure parameter at another site in the circulatory system, means responsive to an output from the determining means for providing a first signal representative of a change of at least a predetermined amount in the first pressure parameter indicative of possible hemodynamic compromise, means responsive to an output from the determining means for developing a second signal representative of a change of at least a given amount in the second pressure parameter indicative of possible hemodynamic compromise, and, charging and enabling discharge of the electrical energy stored by the storage means across the electrode means as at least one cardioverting/defibrillation pulse upon contemporaneous presence of both the first and the second signals.

14. The system according to claim 13, wherein the means responsive to the first signal and the second signal includes 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.

15. The system according to claim 13, including electrical means for sensing heart rate and producing a distinctive control signal upon the heart rate exceeding a predetermined rate, and wherein the means responsive to the first signal and to the second signal enables discharge of the storage means upon contemporary presence of the first signal, the second signal and the control signal.

16. The system according to claim 15, including antitachycardia pacemaking means responsive to presence of the distinctive control signal and contemporaneous absence of at least one of the first signal and the second signal for delivering pacing signals to the heart whereby tachycardia may be overcome.

17. The system according to claim 15, 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 wherein 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.

18. The system according to claim 17, 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 synchronization signal, to effect defibrillation.

19. The system according to claim 13, including means for discharging electrical energy across said electrode means and into the heart effects discharge on a nonsynchronized basis to effect defibrillation.

20. The system according to claim 13, including means for establishing respective fixed signal representations of the respective first pressure parameter and the second pressure parameter.

21. The system according to claim 13, including means for establishing respective variable signal representations of respective baselines for the first pressure parameter determined over a predetermined period and the second pressure parameter determined over a given period.

22. A method of treating a malfunctioning heart comprising monitoring right atrial pressure or central venous pressure, monitoring right ventricular pressure, determining if the right atrial pressure increases by at least a predetermining amount, determining if the right ventricular pressure decreases by at least a given amount, and delivering cardioverting/defibrillating electrical energy to the heart upon to determining that the right atrial pressure has increased by at least the predetermined amount and the right ventricular pressure has decreased by at least the given amount.

23. The method according to claim 22, wherein the step of monitoring right atrial pressure or central venous pressure comprises monitoring mean right atrial pressure or mean central venous pressure, wherein the step of monitoring right ventricular pressure comprises monitoring right ventricular systolic pressure, wherein the step of determining pressure increases comprises determining if the mean right atrial pressure or central venous pressure increases by at least a predetermined amount, wherein the step of determining pressure decreases comprises determining if the right ventricular systolic pressure decreases by at least a given amount, and wherein the delivering step comprises delivering cardioverting/defibrillating electrical energy to the heart upon to determining that the mean right atrial pressure has increased by at least the predetermined amount and the right ventricular pressure has decreased by at least the given amount.

24. The method according to claim 23, including sensing heart rate, the step of delivering cardioverting/defibrillating electrical energy being taken only upon the heart rate exceeding a given rate.

25. The method according to claim 23, including establishing respective fixed baselines for mean right atrial pressure or mean central venous pressure and for right ventricular systolic pressure against which, the respective mean right atrial pressure and the right ventricular pressure respective increases and decreases are determined.

26. The method according to claim 23, including establishing a variable baseline for mean right atrial pressure or mean central venous pressure determined over a predetermined period of time, establishing a variable baseline for right ventricular systolic over a given period of time, the respective increases and decreases being determined against the respective variable baselines.

27. The method according to claim 22, including sensing heart rate, the step of delivering cardioverting/defibrillating electrical energy being taken only upon the heart rate exceeding a given rate.

28. The method according to claim 22, including establishing respective fixed baselines for right atrial pressure or central venous pressure and for right ventricular pressure against which, the respective right atrial pressure or central venous pressure and the right ventricular pressure respective increases and decreases are determined.

29. The method according to claim 22, including establishing a variable baseline for right atrial pressure or central venous pressure determined over a predetermined period of time, establishing a variable baseline for right ventricular pressure over a given period of time, the respective increases and decreases being determined against the respective variable baselines.

30. A method of treating a malfunctioning heart comprising monitoring a first pressure parameter at one site in a circulatory system, monitoring a second presume parameter at another site int he circulatory system, determining if the first pressure parameter changes by at least a predetermining amount indicative of possible hemodynamic compromise, determining if the second pressure parameter changes by at least a given amount indicative of possible hemodynamic compromise, and delivering at least one pulse of cardioverting/defibrillating electrical energy to the heart upon determining that the first pressure parameter has changed by at least the predetermined amount and the second pressure parameter has also changed by at least the given amount.

31. The method according to claim 30, including sensing heart rate, the step of delivering cardioverting/defibrillating electrical energy being taken only upon the heart rate exceeding a given rate.

32. The method according to claim 30, including establishing respective fixed baselines for the first pressure parameter and for a second pressure parameter against which the respective pressure changes are determined.

33. The method according to claim 30, including establishing a variable baseline for the first pressure parameter, determined over a predetermined period of time, establishing a variable baseline for the second pressure parameter, determined over a given period of time, against which the respective changes are determined.

34. In a system for treating a malfunctioning heart of the type which includes storage means for storing electrical energy and electrode means for electrically coupling the storage means to the heart, an improvement comprising determining means for determining a first hemodynamic parameter and a second hemodynamic parameter in a circulatory system, and means for enabling discharge of at least one pulse of cardioverting/defibrillating electrical energy from the electrical energy stored by the storage means across the electrode means upon output from the determining means indicating that the first hemodynamic parameter has changed by at least a predetermined amount indicative of possible hemodynamic compromise and the second hemodynamic parameter has also changed by at least a predetermined amount indicative of possible hemodynamic compromise.

35. The system according to claim 34, wherein said determining means for determining a first hemodynamic parameter and a second hemodynamic parameter comprise means for determining at least two pressure parameters selected from means right atrial pressure, mean central venous pressure, right ventricular systolic pressure, right ventricular pulse pressure and mean arterial pressure.

36. The system according to claim 34, wherein said determining means comprise means for determining a first pressure parameter at one site in the circulatory system and for determining a second pressure at another site in the circulatory system.

37. A method of treating a malfunctioning heart comprising monitoring at least two hemodynamic parameters in a circulatory system, determining if the first hemodynamic parameter and the second hemodynamic parameter charge by at least respective predetermined amounts indicative in each case of possible hemodynamic compromise, and delivering at least one pulse of cardioverting/defibrillating electrical energy to the heart upon determining that each of the hemodynamic parameters have changed in the respective predetermined amounts.

38. The method according to claim 37, wherein the step of monitoring comprises monitoring respective ones of the at least two pressure parameters at respective first and second sites in the circulatory system.

39. The method according to claim 37, wherein the monitoring step comprises monitoring at least two pressure parameters selected from means right aterial pressure, mean central venous pressure, right ventricular systolic pressure, right ventricular pulse pressure and mean aterial pressure.