Cardiovascular support control system

• US 6,735,532 B2
• Filed: 11/18/2002
• Issued: 05/11/2004
• Est. Priority Date: 09/30/1998
• Status: Expired due to Term

• Current Assignee: L3 Technologies, Inc. (L3Harris Technologies, Inc.)
• Original Assignee: L3 Technologies, Inc. (L3Harris Technologies, Inc.)
• Inventors: Freed, Paul S., DeDecker, Paul G., Psakhis, Michael
• Primary Examiner(s): Bui, Bryan
• Application Number:
  US10/298,502
• Publication Number:
  US 20030074144A1
• Time in Patent Office: 540 Days
• Field of Search: 702/50, 702/55, 702/81, 702/89, 702/98, 702/100, 702/139, 702/156, 600/16, 600/17, 600/18
• US Class Current: 702/50
• CPC Class Codes: A61M 2039/0258 for vascular access, e.g. blood stream access
• CPC Class Codes: A61M 60/139 inside the aorta, e.g. intra-aortic balloon pumps
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/161 mechanically acting upon the outside of the patient's blood vessel structure, e.g. compressive structures placed around a vessel
• CPC Class Codes: A61M 60/178 drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
• CPC Class Codes: A61M 60/274 the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
• CPC Class Codes: A61M 60/295 Balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/427 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/88 Percutaneous cables

Abstract

An apparatus and method for assisting cardiac function of a patient includes a flaccid inflatable chamber held at a predetermined volume generally midway between fully inflated and fully deflated for performing a periodically scheduled patient monitoring routine for measuring values of the physiology of the patient, and reinflating the chamber after either detecting a dicrotic notch or expiration of a measurement time period window, whichever occurs first. A software program is connectible in electronic communication with the control program for adjusting settings of the drive unit. The software program is capable of one or more of the following functions: retrieving current values of physician programmable parameters, selectively retrieving a history of the drive unit operation including error detection records, displaying a continuous ECG, and/or displaying a single-beat sample of aortic pressure waveform obtained in real time from the patient.

Claims

1. A method for assisting cardiac function during a cardiac cycle of a patient having a cardiac assist device with an inflatable chamber operably disposed with respect to an aorta of the patient comprising the steps of:

isolating the inflatable chamber from a source of pressurized fluid when the inflatable chamber is in a flaccid state, wherein the inflatable chamber is defined at least in part by a flexible membrane and the flexible membrane is flaccid when held at a predetermined volume of fluid generally midway between a fully inflated predetermined volume and a fully deflated predetermined volume;

measuring a pressure waveform over time in the inflatable chamber with a pressure sensor located external with respect to the patient, wherein pressure in the inflatable chamber corresponds to blood pressure of the patient; and

reinflating the inflatable chamber to the fully inflated predetermined volume of fluid delivered from the source of pressurized fluid, after one of either a detection of a dicrotic notch during a predetermined measurement time period window, or expiration of the measurement time period window in the absence of dicrotic notch detection, whichever occurs first.

2. The method of claim 1 further comprising the step of:

storing the measured pressure wave form over time of the inflatable chamber for at least a partial cardiac cycle.

3. The method of claim 1 wherein the step of reinflating the inflatable chamber further includes the step of:

measuring a differential pressure across an inflation valve disposed between the inflatable chamber and the source of pressurized fluid.

4. The method of claim 3 wherein reinflating the inflatable chamber further includes the steps of:

accumulating the volume introduced during each sampling time interval; and

comparing accumulated volume to a predetermined volume value.

5. The method of claim 4 wherein reinflating the inflatable chamber further includes the step of:

closing an inflation valve when the accumulated volume introduced into the inflatable chamber is at least equal to the predetermined volume value.

6. An apparatus for assisting cardiac function during a cardiac cycle of a patient having a cardiac assist device with an inflatable chamber operatively disposed with respect to an aorta of the patient comprising:

means for isolating the inflatable chamber when in a flaccid state from a source of pressurized fluid, wherein the inflatable chamber is defined at least in part by a flexible membrane and the flexible membrane is flaccid when held at a predetermined volume of fluid generally midway between a fully inflated predetermined volume and a fully deflated predetermined volume;

means for measuring a pressure waveform over time in the inflatable chamber with a pressure sensor located external with respect to the patient, wherein pressure in the inflatable chamber corresponds to blood pressure of the patient; and

means for reinflating the inflatable chamber to the fully inflated predetermined volume of fluid delivered from the source of pressurized fluid, after one of either detection of a dicrotic notch during a predetermined measurement time period window, or expiration of the measurement time period window in the absence of dicrotic notch detection, whichever occurs first.

7. The apparatus of claim 6 further comprising:

means for storing the measured pressure wave form over time of the inflatable chamber for at least a partial cardiac cycle.

8. The apparatus of claim 6 further comprising:

means for measuring a differential pressure across an inflation valve disposed between the inflatable chamber and the source of pressurized fluid.

9. The apparatus of claim 8 wherein the means for measuring differential pressure across the inflation valve further comprises:

a first pressure sensor located upstream of the inflation valve; and

a second pressure sensor located downstream of the inflation valve.

10. The apparatus of claim 6 further comprising:

a pressure reservoir for containment of a quantity of gas under pressure.

11. The apparatus of claim 6 further comprising:

drive means for cyclically controlling an inflation/deflation cycle of the inflatable chamber in response to patient parameters relating to heart function, the drive means having at least one inflation valve, at least one deflation valve, and control means for selectively opening and closing the valves.

12. The apparatus of claim 6 further comprising:

means for sensing a pressure waveform over time during the cardiac cycle of the patient comprising the steps of;

isolating the inflatable chamber when in a flaccid state from a source of pressurized fluid, wherein the inflatable chamber is defined at least in part by a flexible membrane and the flexible membrane is flaccid when held at a predetermined volume of fluid generally midway between a fully inflated predetermined volume and a fully deflated predetermined volume;

measuring a pressure waveform over time in the inflatable chamber with a pressure sensor located external with respect to the patient, wherein pressure in the inflatable chamber corresponds to blood pressure of the patient; and

reinflating the inflatable chamber to the fully inflated predetermined volume of fluid delivered from the source of pressurized fluid, after one of either a detection of a dicrotic notch during a predetermined measurement time period window, or expiration of the measurement time period window in the absence of dicrotic notch detection, whichever occurs first.

13. A method for assisting cardiac function during a cardiac cycle of a patient having a cardiac assist device with an inflatable chamber operatively disposed with respect to an aorta of the patient comprising the steps of:

cyclically inflating and deflating the inflatable chamber with a pressurized gaseous fluid synchronously with a heart beat of the patient based on a first set of programmable patient parameters relating to heart function;

periodically conducting a patient monitoring procedure, wherein the procedure includes the steps of;

partially deflating the inflatable chamber to a predetermined volume of pressurized gaseous fluid;

isolating the inflatable chamber from a source of the pressurized gaseous fluid and allowing the inflatable chamber to settle so that the inflatable chamber acts as a transducer;

measuring a pressure waveform over time in the inflatable chamber with an external pressure sensor, wherein the pressure in the inflatable chamber corresponds to current blood pressure of the patient;

monitoring pressure in the inflatable chamber for at least a partial cardiac cycle;

reinflating the inflatable chamber to a fully inflated predetermined volume after one of either a detection of a dicrotic notch during a predetermined measurement time period window, or expiration of the measurement time period window in the absence of dicrotic notch detection, whichever occurs first;

storing the monitored pressure values in memory of a controller;

updating patient parameters based on the stored pressure values; and

thereafter, cyclically inflating and deflating the inflatable chamber with pressurized gaseous fluid according to the updated patient parameters until modified by another patient monitoring procedure.

14. The method of claim 13 wherein the reinflating step further comprises the steps of:

introducing pressurized fluid into the inflatable chamber through an inflation valve;

measuring a differential pressure across the inflation valve; and

integrating the differential pressure with respect to a time interval corresponding to an amount of time the inflation valve is in an open position to determine a volume of fluid introduced into the inflatable chamber.

15. The method of claim 13 wherein the conducting step is performed at predetermined time intervals.

16. The method of claim 13 further comprising the steps of:

monitoring a heart beat rate of the patient; and

performing the conducting step immediately, if a monitored change in heart beat rate of the patient exceeds a predetermined percentage.

17. The method of claim 13 further comprising the step of:

selectively scheduling the patient monitoring procedure for execution at a time interval ranging from three minutes to twenty minutes, inclusive.

18. The method of claim 13 further comprising the step of:

selectively scheduling a patient monitoring procedure, if a heart rate of the patient changes by more than a preselected percentage value of an average of a predetermined number of previously measured heart rate values, the preselected percentage value selected in a range between 10% to 80%, inclusive.

19. An apparatus for assisting cardiac function of a patient comprising:

an inflatable chamber operably positionable with respect to an aorta of the patient;

a percutaneous access device implantable with respect to a hypogastric region of the patient and connectible in fluid communication with the inflatable chamber; and

a drive unit connectible through the percutaneous access device for selectively inflating and deflating the inflatable chamber in accordance with a control program stored in memory, the control program for controlling the drive unit in response to a periodically scheduled patient monitoring routine for measuring values of the physiology of the patient, and the control program using measured values as modified in accordance with the control program and physician programmable parameters for assisting cardiac function of the patient, wherein the control program interrupts counterpulsation for at least a partial cardiac cycle to perform a periodically scheduled patient monitoring routine in order to obtain at least a partial aortic pressure waveform, and a Q-S₂ interval is measured by the control program from the at least partial aortic pressure waveform obtained.

20. The apparatus of claim 19 wherein the control program further comprises:

a patient parameter table having physician programmable parameters for modifying cardiac function assistance provided to the patient.

21. The apparatus of claim 19 wherein each of the physician programmable parameters is restricted to a value greater than or equal to a predefined minimum value and less than or equal to a predefined maximum value.

22. The apparatus of claim 19 wherein each of the physician programmable parameters has a predefined default value.

23. The apparatus of claim 19 further comprising:

a software program connectible in electronic communication with the control program for adjusting settings of the drive unit.

24. The apparatus of claim 23 wherein the software program retrieves current values of physician programmable parameters.

25. The apparatus of claim 23 wherein the software program selectively retrieves a history of the drive unit operation including error detection records.

26. The apparatus of claim 23 wherein the software program is configurable to display a continuous ECG.

27. The apparatus of claim 23 wherein the software program is configurable to display a single-beat sample of aortic pressure waveform obtained in real time from the patient.

28. The apparatus of claim 19 wherein the control program uses the interval to adjust inflation timing of the blood pump, as modified in accordance with the physician programmable parameters, in response to changes in the heart rate and hemodynamic state of the patient.

29. A program stored in memory for assisting cardiac function during a cardiac cycle of a patient having a cardiac assist device with drive unit connectible to an inflatable chamber operatively disposed with respect to an aorta of the patient comprising the steps of:

automatically controlling the drive unit in response to a periodically scheduled patient monitoring routine for measuring values of physiology of the patient;

using measured values as modified in accordance with physician programmable parameters for assisting cardiac function of the patient;

interrupting counterpulsation for at least a partial cardiac cycle to perform the periodically scheduled patient monitoring routine in order to obtain at least a partial aortic pressure waveform; and

measuring a Q-S₂ interval by the control program from the at least partial aortic pressure waveform obtained.

30. The program of claim 29 further comprising the step of:

providing a patient parameter table having a plurality of physician programmable parameters for modifying cardiac function assistance provided to the patient.

31. The program of claim 29 wherein each of the physician programmable parameters is restricted to a value greater than or equal to a predefined minimum value and less than or equal to a predefined maximum value.

32. The program of claim 29 wherein each of the physician programmable parameters has a predefined default value.

33. The program of claim 29 further comprising the step of:

adjusting settings of the drive unit with a software program connectible in electronic communication with the drive unit.

34. The program of claim 33 wherein the software program retrieves current values of physician programmable parameters.

35. The program of claim 33 wherein the software program selectively retrieves a history of the drive unit operation including error detection records.

36. The program of claim 33 wherein the software program is configurable to display a continuous ECG.

37. The program of claim 33 wherein the software program is configurable to display a single-beat sample of aortic pressure waveform obtained in real time from the patient.

38. The program of claim 29 further comprising the step of:

using the measured Q-S₂ interval to adjust inflation timing of the blood pump, as modified in accordance with the physician programmable parameters, in response to changes in the heart rate and hemodynamic state of the patient.