Circulatory assist method and apparatus

• US 5,020,516 A
• Filed: 03/31/1988
• Issued: 06/04/1991
• Est. Priority Date: 03/31/1988
• Status: Expired due to Term

• Current Assignee: Bernoulli Enterprise, Inc. (Koninklijke Philips N.V.)
• Original Assignee: Cardiopulmonary Corporation (Koninklijke Philips N.V.)
• Inventors: Mentelos, Richard A., Biondi, James W.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Schaetzle, Kennedy J.
• Application Number:
  US07/175,810
• Time in Patent Office: 1,160 Days
• Field of Search: 128/671, 128/695, 128/696, 128/700, 128/725, 128/30.2, 128/28, 128/24 R, 128/204.23, 128/204.24, 128/64, 128/668, 128/713, 128/716, 128/718, 128/719, 600/16, 600/17
• US Class Current: 601/44
• CPC Class Codes: A61H 2201/0103 inflatable
• CPC Class Codes: A61H 2201/1238 with hydraulic or pneumatic drive
• CPC Class Codes: A61H 2201/165 Wearable interfaces
• CPC Class Codes: A61H 2201/5007 computer controlled
• CPC Class Codes: A61H 2201/5043 Displays
• CPC Class Codes: A61H 2230/207 partial O2-value
• CPC Class Codes: A61H 2230/25 Blood flowrate, e.g. by Doppler effect
• CPC Class Codes: A61H 31/005 with feedback for the user
• CPC Class Codes: A61H 31/006 Power driven
• CPC Class Codes: A61H 9/0078 with intermittent or alternately inflated bladders or cuffs mattresses for preventing bed-sores with alternated pressurized chambers A61G7/05776
• CPC Class Codes: A61M 16/0096 High frequency jet ventilation
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/1025 the O2 concentration
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/435 partial O2 pressure (P-O2)
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/165 : implantable in, on, or around the heart
• CPC Class Codes: A61M 60/38 : Blood oxygenation
• CPC Class Codes: A61M 60/515 : Regulation using real-time patient data
• CPC Class Codes: A61M 60/523 : using blood flow data, e.g. from blood flow transducers
• CPC Class Codes: A61M 60/569 : synchronous with the native heart beat
• CPC Class Codes: A61M 60/592 : Communication of patient or blood pump data to distant operators for treatment purposes

Abstract

Improved cardiocirculatory assistance is provided to a patient by detecting the onset of ventricular ejection in the cardiac cycle of the patient and selectively increasing intrathoracic pressure of the patient in relative phase with respect to the onset of ventricular ejection. Cardiocirculatory output may be monitored and the relative phase of the increase in intrathoracic pressure with respect to the onset of ventricular ejection adjusted to maximize cardiac output. The intrathoracic pressure is increased once every N cardiac cycles where N is a positive integer. The patient interface may include apparatus for supplying high frequency respiration pulses in synchronism with the cardiac cycle. Alternately, or in addition, the pulses may be used to inflate a bladder in contact with the thorax.

Claims

1. A method for providing circulatory assistance to a patient, comprising the steps of:

detecting the onset of ventricular ejection in the cardiac cycle of the patient,

continuously or periodically monitoring the patient'"'"'s cardiac output on a breath by breath basis and providing output signals indicative thereof,

selectively increasing intrathoracic pressure of the patient by injecting a respiratory fluid into the patient'"'"'s lungs in relative phase with respect to said ventricular ejection, and

repeatedly in response to said output signals adjusting said relative phase of pressure increase to ventricular ejection to maximize cardiac output by reducing ventricular afterload and maintaining ventricular preload.

2. The method of claim 1, wherein said step of selectively increasing said intrathoracic pressure is performed once every N cardiac cycles, where N is a positive integer.

3. The method of claim 2, wherein said positive integer is one or two.

4. The method of claim 1, further comprising the step of:

adjusting the duration of a time interval for which said increasing of intrathoracic pressure occurs to maximize said cardiac output.

5. The method of claim 4, further comprising repeatedly adjusting said time interval duration concurrently with adjusting said relative phase to maximize said output.

6. The method of claim 1, wherein said step of monitoring said cardiocirculatory output comprises:

determining oxygen uptake by the patient;

determining the difference in arterial oxygen concentration and venous oxygen concentration; and

dividing the oxygen uptake by said oxygen concentration difference to determine said cardiocirculatory output.

7. An apparatus for improving the cardiac output of a patient said apparatus comprising:

detection means for detecting the onset of ventricular ejection in the cardiac cycle of the patient;

pressure increasing means including means for injecting a respiratory fluid into the patient'"'"'s lungs for selectively increasing intrathoracic pressure of the patient;

control means responsive to said detection means for activating said pressure increasing means in relative phase with respect to said ventricular ejection;

cardiocirculatory monitoring means for continuously or periodically monitoring the patient'"'"'s cardiac output on a breath by breath basis and for providing output signals indicative thereof; and

delay means responsive to said output signals for delaying activation of said control means in response to said detecting means and for thereby repeatedly adjusting said relative phase of pressure increase to ventricular ejection so that said cardiac output is maximized by reducing ventricular afterload and maintaining ventricular preload.

8. The apparatus of claim 7, wherein said cardiocirculatory monitoring means includes means for determining the rate of flow of blood from the heart.

9. The apparatus of claim 7, wherein said cardiocirculatory monitoring means includes an oxygen consumption monitoring means for determining the rate of oxygen consumption of the patient.

10. The apparatus of claim 9, wherein said oxygen consumption monitoring means comprises:

means for supplying an oxygen stream to the patient,

first concentration measuring means for measuring concentration of oxygen in said oxygen stream;

second concentration measuring means for measuring concentration of oxygen in said stream at a point including gases exhausted by the patient; and

flow measuring means for measuring the flow rate of gases in said stream.

11. The apparatus of claim 10, further comprising blood oxygen measuring means for measuring the difference in arterial oxygen concentration and venous oxygen concentration of the patient and for providing a difference output indicative of said difference in arterial oxygen concentration and venous oxygen concentration.

12. The apparatus of claim 11, further comprising calculating means for determining cardiac output;

said calculating means including;

difference means for determining the difference in said oxygen concentration measured by said first concentration measuring means and said second concentration measuring means;

multiplying means for multiplying said difference in oxygen concentrations by said flow rate measured by said flow measuring means to determine a value of instantaneous oxygen consumption; and

dividing means for dividing said value of instantaneous oxygen consumption by said difference output of said blood oxygen measuring means to determine a cardiac output value.

13. The apparatus of claim 12, further comprising integrating means for integrating values of said cardiac output to determine an averaged cardiac output.

14. The apparatus of claim 13, wherein said integrating means comprises:

a first in/first out memory for storing said values of cardiac output; and

means for determining the sum of said values in said memory.

15. The apparatus of claim 7, further comprising divider means responsive to said detection means, said divider means providing an output every N cardiac cycles, where N is a positive integer, and said control means being responsive to said output of said divider means.

16. The apparatus of claim 15, further comprising selection means for selecting said positive integer.

17. The apparatus of claim 16 wherein said positive integer may be selected by said selection means to be one or two.

18. The apparatus of claim 7, wherein said pressure increasing means comprises:

a source of pressurized respiratory fluid;

pressure pulse means for providing pulses of said pressurized respiratory fluid; and

a patient interface means for utilizing said pulses to increase said intrathoracic pressure.

19. The apparatus of claim 18, wherein said pressurized respiratory fluid is air or an air/oxygen mixture and said patient interface means includes a tube for supplying said pressure pulses to the lungs for inspiration by the patient.

20. An apparatus for improving the cardiac output of a patient, said apparatus comprising:

detection means for detecting the onset of ventricular ejection in the cardiac cycle of the patient;

continuously or periodically monitoring means for monitoring the patient'"'"'s cardiac output on a breath by breath basis,

pressure increasing means including means for injecting a respiratory fluid into the patient'"'"'s lungs for selectively increasing intrathoracic pressure of the patient; and

control means responsive to said detection means for activating said pressure increasing means in relative phase with respect to said ventricular ejection and for repeatedly adjusting said relative phase of pressure increase to ventricular ejection to maximize cardiac output by reducing ventricular afterload and maintaining ventricular preload.

21. An apparatus for improving the cardiac output of a patient, said apparatus comprising:

detection means for detecting the onset of ventricular ejection in the cardiac cycle of the patient;

pressure increasing means for selectively increasing, intrathoracic pressure of the patient;

control means responsive to said detection means for activating said pressure increasing means in relative phase with respect to said ventricular ejection;

cardiocirculatory monitoring means for ascertaining the extent of cardiac output improvement and for providing an output signal indicative thereof, said cardiocirculatory monitoring means including oxygen consumption monitoring means for determining the rate of oxygen consumption of the patient, and said oxygen consumption monitoring means comprising (i) means for supplying an oxygen stream to the patient, (ii) first concentration measuring means for measuring concentration of oxygen in said oxygen stream, (iii) second concentration measuring means for measuring concentration of oxygen in said stream at a point including gases exhausted by the patient, and (iv) flow measuring means for measuring the flow rate of gases in said stream, said cardiocirculatory monitoring means including calculating means responsive to said means (i)-(iv) for producing said output signal, and

delay means responsive to said output signal, said delay means being for delaying activation of said control means in response to said detecting means so that said cardiac output is maximized.

22. The apparatus of claim 21, further comprising blood oxygen measuring means for measuring the difference in arterial oxygen concentration and venous oxygen concentration of the patient and for providing a difference output indicative of said difference in arterial oxygen concentration and venous oxygen concentration.

23. The apparatus of claim 22, wherein, said calculating means comprises:

difference means for determining the difference in oxygen concentration measured by said first concentration measuring means and said second concentration measuring means;

multiplying means for multiplying said difference by said flow rate measured by said flow measuring means to determine a value of instantaneous oxygen consumption; and

dividing means for dividing said value of instantaneous oxygen consumption by said difference output of said blood oxygen measuring means to determine a cardiac output value.

24. The apparatus of claim 23, further comprising integrating means for integrating values of said cardiac output to determine an averaged cardiac output.

25. The apparatus of claim 24, wherein said integrating means comprises:

a first in/first out memory for storing said values of cardiac output; and

means for determining the sum of said values in said memory.