Retroperfusion control apparatus, system and method

• US 4,865,581 A
• Filed: 05/29/1987
• Issued: 09/12/1989
• Est. Priority Date: 05/29/1987
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Retroperfusion Systems, Inc.
• Inventors: Lundquist, Ingemar H., Kardos, Thomas J., Tarczy-Hornoch, Zoltan
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US07/056,401
• Time in Patent Office: 837 Days
• Field of Search: 128/1 D, 604/67, 600/16, 600/17, 600/18
• US Class Current: 600/18
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/3643 Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3644 Mode of operation
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/102 driven by a solenoid-activated pump
• CPC Class Codes: A61M 2025/1022 driven by a rotary motor-activated pump
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/13 : by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
• CPC Class Codes: A61M 60/408 : the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable
• 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

Retroperfusion control apparatus for supplying arterial blood of a patient to the venous side of the patient'"'"'s heart including a pump having an inlet and an outlet and a piston movable through a pump stroke for moving a liquid from the inlet to the outlet of the pump. A stepper motor is provided which drives the piston. Electronic circuitry is provided for driving the stepper motor and senses the presence of an R wave in a patient to operate the stepper motor in response to the sensed R wave.

Claims

1. In a control apparatus for supplying arterial blood of a patient to the venous side of the patient'"'"'s heart, a pump having an inlet adapted to be coupled to an artery of the patient and an outlet, a catheter coupled to the outlet and adapted to be connected to a vein of the patient, the catheter having an inflatable balloon mounted thereon, movable means forming a part of the pump movable through a pump stroke for moving a liquid from the inlet to the outlet of the pump, a stepper motor, means coupling the stepper motor to the movable means, and electronic circuitry for driving the stepper motor, the electronic circuitry including means for sensing the presence of an R wave in an electrocardiogram of a patient and for operating the stepper motor in response to the sensed R wave.

2. Apparatus as in claim 1 wherein the pump is in the form of a removable disposable pump cassette.

3. Apparatus as in claim 2 wherein the movable means is a piston mounted for reciprocatory movement in the pump cassette in upstroke and downstroke directions and wherein the stepper motor is rotated in one direction during the upstroke direction and wherein the stepper motor is operated in a reverse direction during the downstroke direction.

4. Apparatus as in claim 1 wherein said electronic circuitry includes a microprocessor for generating digital output signals for operating the stepper motor.

5. Apparatus as in claim 4 together with a bubble chamber coupled to the pump for receiving arterial blood and wherein said electronic circuitry includes detecting means associated with the bubble chamber and connected to the microprocessor for informing the microprocessor when bubbles of air appear in the arterial blood supply and also when the amount of arterial blood drops below a predetermined level to stop operation of the pump.

6. Apparatus as in claim 4 together with a pump console, wherein the stepper motor is mounted in the pump console and wherein the means coupling the stepper motor in the movable means is also in the pump console and electrical means carried by the pump console and adapted to be engaged by the pump for ascertaining when the pump is in a proper position and for supplying an electrical signal to the microprocessor when the pump is improperly positioned in the pump console to cause the microprocessor to initiate an alarm condition.

7. Apparatus as in claim 4 together with means coupled to the microprocessor for cutting off arterial blood flow through the pump when movement of the movable means ceases.

8. Apparatus as in claim 7 wherein said means for cutting off arterial blood flow includes a pinch-off valve mounted on the pump console for controlling the flow of arterial blood through the pump and means connecting the pinch-off valve to the microprocessor for controlling operation of the pinch-off valve.

9. Apparatus as in claim 4 together with means for sensing the position of the stepper motor connected to the microprocessor for supplying information to the microprocessor as to the location of the movable means of the pump.

10. Apparatus as in claim 4 wherein the microprocessor is programmable and has been programmed to start the pump stroke at approximately 45% of the R wave to R wave interval and terminates at approximately 95% of the R wave to R wave interval and wherein the digital output signals to the stepper motor for the upstroke are supplied during an initial portion of the time period for the upstroke so that a pause is provided at the upper extremity of the pump stroke and prior to the downstroke so as to permit any pressure buildup in the pump to dissipate and to permit a continued flow of blood to occur prior to the downstroke.

11. Apparatus as in claim 10 wherein the microprocessor has been programmed so that approximately one half of the time allotted for the upstroke is allotted for the pause after the upstroke.

12. Apparatus as in claim 4 wherein said electronic circuitry includes means to cause a predetermined mean flow to be supplied to the patient which is independent of the heart rate of the patient.

13. Apparatus as in claim 12 wherein said means to cause a predetermined mean flow includes a program in the microprocessor.

14. Apparatus as in claim 4 together with an external ECG monitor adapted to be coupled to the patient and supplying an R trigger circuit signal and wherein the microprocessor includes means for creating a pattern from the R trigger circuit signal and means for comparing the signal received from the external ECG monitor with the pattern for ascertaining whether the R trigger circuit signal received is appropriate for operating the pump.

15. Apparatus as in claim 4 together with display means coupled to the microprocessor for displaying an electrocardiogram, the R wave and the pump stroke in a timed relationship.

16. Apparatus as in claim 4 wherein said electronic circuitry includes detecting means connected to the microprocessor for informing the microprocessor of the arterial pressure of the patient.

17. Apparatus as in claim 16 wherein said detecting means for detecting arterial pressure is used to detect the presence of diastole in a patient independently from the electrocardiogram R wave signal.

18. Apparatus as in claim 4 wherein said electronic circuitry includes detecting means connected to the microprocessor for supplying coronary sinus pressure of the patient to the microprocessor.

19. A method for supplying arterial blood into a venous region of the heart, comprising taking an electrocardiogram of the patient, ascertaining when an R wave is present in the electrocardiogram, supplying arterial blood from the patient under positive pressure into a venous region of the heart for a predetermined period of time in accordance with the R wave of the patient, providing a pause period for a predetermined period of time to permit any positive pressure created to be dissipated and to permit continued flow to occur and thereafter allowing antegrade flow of venous blood from the heart for a predetermined period of time in accordance with the R wave of the patient.

20. A method as in claim 19 wherein the pause period is made substantially equal to the period during which arterial blood is being introduced under positive pressure.

21. A method as in claim 20 wherein the time for antegrade flow of arterial blood is made to be substantially equal to the period of time in which arterial blood is supplied retrograde under positive pressure and the period during which the pause occurs.

22. A method as in claim 19 together with the steps of sensing any change in heart rate and making adjustments in the arterial blood supplied so that arterial blood is supplied to the patient at a substantially constant mean blood flow rate.

23. A method as in claim 19 together with the step of independently generating an R-wave pattern, comparing the R wave from the electrocardiogram with an independently generated R wave pattern to ascertain whether on R wave has been received from the patient which is appropriate for supplying arterial blood into a venous region of the heart.

24. A method as in claim 19 together with the step of detecting bubbles of air in the arterial blood supply, cutting off the arterial blood flow, and initiating an alarm.

25. A method as in claim 19 together with the step of collecting arterial blood in a reservoir, detecting when the level of arterial blood in the reservoir drops below a predetermined level and initiating an alarm.

26. A method as in claim 19 to initiate an alarm if the heart rate exceeds a predetermined value.

27. A method as in claim 19 to initiate an alarm if the heart rate drops below a predetermined value.

28. A method as in claim 19 for use with a pump having a movable means for pumping arterial blood together with the step of sensing the location of the movable means in the pump to initiate an alarm if the location of the movable means does not change in a predetermined manner.

29. A method as in claim 28 together with the step of determining whether an R wave of the patient is appropriate for operation of the movable means, and whether aborting continued movement of the movable means during the R wave of the patient is deemed to be inappropriate for operation of the movable means.