Hemodynamically responsive system for and method of treating a malfunctioning heart

• US 5,054,485 A
• Filed: 06/01/1990
• Issued: 10/08/1991
• 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:
  US07/531,867
• Time in Patent Office: 494 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 and 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 difference (or ratio) between MRAP and RVSP reaches at least a predetermined value, 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 predetermined value is to be measured may be provided. Other hemodynamic parameters, such as RVDP, RVSP, MRVP and/or MAP could be used as one or another of the hemodynamic parameters.

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 either right atrial pressure and right ventricular pressure or central venous pressure and right ventricular pressure, means responsive to an output from the determining means for providing a signal whenever a relationship between either right atrial pressure and right ventricular pressure or central venous pressure and right ventricular pressure reaches at least a predetermined value indicative of hemodynamic compromise, and means responsive to the signal for charging and enabling discharge of the electrical energy stored by the storage means across the electrode means upon the relationship reaching at least the predetermined value.

2. The system according to claim 1, wherein said determining means comprises means for determining either mean right atrial pressure and right ventricular systolic pressure or mean central venous pressure and right ventricular systolic pressure, and wherein said means responsive comprises means responsive to output from the determining means for providing a signal whenever a relationship between either mean right atrial pressure and right ventricular systolic pressure or mean central venous pressure and right ventricular systolic pressure reaches at least the predetermined value.

3. The system according to claim 2, including means for establishing a fixed signal baseline representation of the predetermined value of the relationship between either mean right atrial pressure and right ventricular systolic pressure or mean central venous pressure and right ventricular systolic pressure.

4. The system according to claim 2, including means for establishing a variable signal baseline representation of the predetermined value of the relationship between either mean right atrial pressure and right ventricular systolic pressure or mean central venous pressure and right ventricular systolic pressure determined over a predetermined period of time.

5. The system according to claim 2, wherein said means responsive to output form the determining means comprises means responsive to output from the determining means for providing a signal whenever the difference between either mean right atrial pressure and right ventricular systolic pressure or mean central venous pressure and right ventricular systolic pressure reaches at least a predetermined value.

6. The system according to claim 2, wherein said means responsive to output from the determining means comprises means responsive to output from the determining means for providing a signal whenever the ratio between either mean right atrial pressure and right ventricular systolic pressure or mean central venous pressure and right ventricular systolic pressure reaches at least a given value.

7. The system according to claim 1, wherein the means responsive to the 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.

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

9. The system according to claim 8, including antitachycardia pacemaking means, responsive solely to the distinctive control signal during periods when the first-said signal is absent, for delivering pacing signals to the heart whereby tachycardia may be overcome.

10. 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 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.

11. The system according to claim 10, 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.

12. 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.

13. The system according to claim 1, including means for establishing a fixed signal baseline representation of either the predetermined value of the relationship between right atrial pressure and right ventricular or central venous pressure and right ventricular pressure.

14. The system according to claim 1, including means for establishing a variable signal baseline representation of the predetermined value of the relationship between either right atrial pressure and right ventricular pressure or central venous pressure and right ventricular pressure determined over a predetermined period of time.

15. The system according to claim 1, wherein said means responsive to output from the determining means comprises means responsive to output from the determining means for providing a signal whenever the difference between either right atrial pressure and right ventricular pressure or central venous pressure and right ventricular pressure reaches at least a predetermined value.

16. The system according to claim 1, wherein said means responsive to output form the determining means comprises means responsive to output form the determining means for providing a signal whenever either the ratio between right atrial pressure and right ventricular pressure or central venous pressure and right ventricular pressure reaches at least a given value.

17. 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 hemodynamic parameter and a second hemodynamic parameter, means responsive to an output from the determining means for providing a signal whenever a relationship between the first and second hemodynamic parameters reaches at least a predetermined value indicative of hemodynamic compromise, and means responsive to the signal for charging and enabling discharge of the electrical energy stored by the storage means across the electrode means as at least one cardioverting pulse upon the relationship reaching at least the predetermined value.

18. The system according to claim 17, wherein the means responsive to the 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.

19. The system according to claim 17, 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-said signal enables discharge of the storage means upon contemporary presence of the first-said signal and the control signal.

20. The system according to claim 19, including antitachycardia pacemaking means, responsive solely to the distinctive control signal during periods when the first-said signal is absent, for delivering pacing signals to the heart whereby tachycardia may be overcome.

21. The system according to claim 19, 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.

22. The system according to claim 21, 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.

23. The system according to claim 17, including means for discharging electrical energy across said electrode means and into the heart effects discharge on a nonsynchronized basis to effect defibrillation.

24. The system according to claim 17, including means for establishing a fixed signal baseline representation of the predetermined value of the relationship between the first hemodynamic parameter and the second hemodynamic parameter.

25. The system according to claim 17, including means for establishing a variable signal baseline representation of the predetermined value of the relationship between the first hemodynamic parameter and the second hemodynamic parameter determined over a predetermined period of time.

26. The system according to claim 17, wherein said means responsive to output from the determining means comprises means responsive to output from the determining means for providing a signal whenever the difference between the first hemodynamic parameter and the second hemodynamic parameter reaches at least a predetermined value.

27. The system according to claim 17, wherein said means responsive to output from the determining means comprises means responsive to output from the determining means for providing a signal whenever the ratio between the first hemodynamic parameter and the second hemodynamic parameter reaches at least a given value.

28. A method of treating a malfunctioning heart comprising monitoring either right atrial pressure or central venous pressure, monitoring right ventricular pressure, determining if a relationship between either right atrial pressure and right ventricular pressure or central venous pressure and right ventricular pressure reaches at least predetermined value indicative of hemodynamic compromise, and delivering cardioverting/defibrillating electrical energy to the heart upon determining that the relationship between either right atrial pressure and right ventricular pressure or central venous pressure and right ventricular pressure has reached at least the predetermined value.

29. The method according to claim 28, wherein the steps of monitoring comprise monitoring mean right atrial pressure and right ventricular systolic pressure or mean central venous pressure and right ventricular systolic pressure, wherein the determining step comprises determining if a relationship between either mean right atrial pressure and right ventricular systolic pressure or mean central venous pressure and right ventricular systolic pressure reaches at least the predetermined value, and wherein the delivering step comprises delivering cardioverting/defibrillating electrical energy to the heart upon determining that the relationship between either mean right atrial pressure and right ventricular pressure or mean central venous pressure and right ventricular pressure has reached at least the predetermined value.

30. The method according to claim 29, including sensing heart rate, the step of delivering cardioverting/defibrillating electrical energy being taken only upon the heart rate exceeding a given rate.

31. The method according to claim 29, including establishing a fixed baseline for the predetermined value.

32. The method according to claim 29, including establishing a variable baseline for the predetermined value based on a relationship between either mean right atrial pressure and right ventricular systolic pressure or mean central venous pressure and right ventricular systolic determined over a predetermined period of time.

33. The method according to claim 28, including sensing heart rate, the step of delivering cardioverting/defibrillating electrical energy being taken only upon the heart rate exceeding a given rate.

34. The method according to claim 28, including establishing a fixed baseline for the predetermined value.

35. The method according to claim 28, including establishing a variable baseline for the predetermined value based on a relationship between either right atrial pressure and right ventricular pressure or central venous pressure and right ventricular pressure determined over a predetermined period of time.

36. A method of treating a malfunctioning heart comprising monitoring a first hemodynamic parameter, monitoring a second hemodynamic parameter, determining if a relationship between the first hemodynamic parameter and the second hemodynamic parameter reaches at least predetermined value, and delivering at least one pulse of cardioverting/defibrillating electrical energy to the heart upon determining that the relationship between the first hemodynamic parameter and the second hemodynamic parameter indicative of hemodynamic compromise has reached at least the predetermined value.

37. The method according to claim 36, including sensing heart rate, the step of delivering cardioverting/defibrillating electrical energy being taken only upon the heart rate exceeding a given rate.

38. The method according to claim 36, including establishing a fixed baseline for the predetermined value.

39. The method according to claim 36, including establishing a variable baseline for the predetermined value based on a relationship between the first hemodynamic parameter and the second hemodynamic parameter determined over a predetermined period of time.

40. The method according to claim 36, wherein at least one of the hemodynamic parameters is a nonpressure parameter.

41. The method according to claim 36, wherein the at least one parameter is mixed venous O₂ saturation, pH, body temperature, blood temperature, cardiac output, cardiac impedance, lactic acid level or a blood ion level.

42. 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 the electrical energy stored by the storage means across the electrode means as at least one pulse of cardioverting/defibrillating energy upon output from the determining means indicating that a relationship between the first hemodynamic parameter and the second hemodynamic parameter has reached at least a predetermined value indicative of hemodynamic compromise.

43. A method of treating a malfunctioning heart comprising monitoring at least two hemodynamic parameters in a circulatory system, determining if a relationship between the first hemodynamic parameter and the second hemodynamic parameter reach at least a predetermined value indicative of hemodynamic compromise, and delivering cardioverting/defibrillating electrical energy to the heart upon determining that the relationship between the hemodynamic parameters has reached at least the predetermined value.