Cardiovascular support control system

• US 6,132,363 A
• Filed: 09/30/1998
• Issued: 10/17/2000
• Est. Priority Date: 09/30/1997
• Status: Expired due to Term

• Current Assignee: L3 Technologies, Inc. (L3Harris Technologies, Inc.)
• Original Assignee: L.VAD Technology, Inc.
• Inventors: Kantrowitz, Adrian, Freed, Paul S., DeDecker, Paul G., Psakhis, Michael
• Primary Examiner(s): Layno, Carl H.
• Application Number:
  US09/164,513
• Time in Patent Office: 748 Days
• Field of Search: 600/16-18
• US Class Current: 600/16
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• 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 60/268 the displacement member being flexible, e.g. membranes, diaphragms or bladders
• 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 60/427 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/538 Regulation using real-time blood pump operational parameter data, e.g. motor current

Abstract

An apparatus for assisting cardiac function of a patient includes 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 controls the drive unit in response to a periodically scheduled patient monitoring routine for measuring values of the physiology of the patient. The control program uses measured values as modified in accordance with the control program and physician programmable parameters for assisting cardiac function of the patient. The program includes 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, and using measured values as modified in accordance with physician programmable parameters for assisting cardiac function of the patient. 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. 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, 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 includes a patient parameter table having physician programmable parameters for modifying cardiac function assistance provided to the patient.

2. The apparatus of claim 1 wherein each of the physician programmable parameters has a predefined default value.

3. The apparatus of claim 1 further comprising:

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

4. The apparatus of claim 3 wherein the software program retrieves current values of physician programmable parameters.

5. 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, 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 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.

6. 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;

a drive unit connectible through the percutaneous access device for selectively inflating and deflating the inflatable chamber in accordance with a control program, 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; and

a software program connectible in electronic communication with the control program for adjusting settings of the drive unit, wherein the software program selectively retrieves a history of the drive unit operation including error detection records.

7. 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;

a drive unit connectible through the percutaneous access device for selectively inflating and deflating the inflatable chamber in accordance with a control program, 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; and

a software program connectible in electronic communication with the control program for adjusting settings of the drive unit, wherein the software program displays a continuous ECG.

8. 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;

a drive unit connectible through the percutaneous access device for selectively inflating and deflating the inflatable chamber in accordance with a control program, 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; and

a software program connectible in electronic communication with the control program for adjusting settings of the drive unit, wherein the software program displays a single-beat sample of aortic pressure waveform obtained in real time from the patient.

9. 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, 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 two cardiac cycles to perform a partial cycle in order to obtain an aortic pressure waveform, a Q-S₂ interval is measured by the control program from the aortic pressure waveform obtained.

10. The apparatus of claim 9 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.

11. A control program 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 positionable 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; and

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

12. The program of claim 11 wherein each of the physician programmable parameters has a predefined default value.

13. The program of claim 11 further comprising the step of:

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

14. The program of claim 13 wherein the software program retrieves current values of physician programmable parameters.

15. A control program 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 positionable 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; and

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

16. A control program 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 positionable 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; and

adjusting settings of the drive unit with a software program connectible in electronic communication with the drive unit, wherein the software program selectively retrieves a history of the drive unit operation including error detection records.

17. A control program 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 positionable 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; and

adjusting settings of the drive unit with a software program connectible in electronic communication with the drive unit, wherein the software program displays a continuous ECG.

18. A control program 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 positionable 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; and

adjusting settings of the drive unit with a software program connectible in electronic communication with the drive unit, wherein the software program displays a single-beat sample of aortic pressure waveform obtained in real time from the patient.

19. A control program 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 positionable 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 two cardiac cycles to perform a partial cycle in order to obtain an aortic pressure waveform; and

measuring a Q-S₂ interval from the aortic pressure waveform obtained.

20. The program of claim 19 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.