Pulsatile fluid delivery system

• US 7,842,003 B2
• Filed: 12/09/2005
• Issued: 11/30/2010
• Est. Priority Date: 12/09/2005
• Status: Active Grant

• Current Assignee: Quest Medical Incorporated (Atrion Corporation)
• Original Assignee: Quest Medical Incorporated (Atrion Corporation)
• Inventors: Hayes, Richard S., Corera, Cristo Suresh, Jones, Kenneth A.
• Primary Examiner(s): Deak; Leslie R
• Application Number:
  US11/297,989
• Publication Number:
  US 20070134101A1
• Time in Patent Office: 1,817 Days
• Field of Search: 604 65- 67, 604/6.11, 604/6.13, 600/16, 600/17, 623/3.1, 623/3.11, 623/3.16, 623/3.17, 422/44, 417/412, 417/426, 417/321, 417/375, 417/477.1, 417/477.2
• US Class Current: 604/6.11
• CPC Class Codes: F04B 49/065 and making use of computers

Abstract

A system for delivering blood, cardioplegia solution, and other medications or fluids in a pulsatile flow pattern to a patient during cardiopulmonary bypass is disclosed. In a preferred embodiment, a pumping apparatus having at least one chamber is utilized in which a pumping action is achieved by compressing one of the chambers with a piston mechanism, while allowing the other chamber to fill with fluid via retracting its respective piston. The instantaneous flow rate of either of the chambers is determined by the speed of the piston. In a preferred embodiment, a pulsatile flow of fluid is achieved by cyclically alternating the velocity of the piston between two different speeds. A desired average flow rate and/or delivery pressure and/or constant pulse pressure is maintained by adjusting the alternating velocities at the desired frequency and duty cycle. The calculations necessary to obtain a desired average flow rate are performed by a microprocessor, which also controls the movement of the pistons.

Claims

1. A method of creating a continuous pulsatile flow of fluid into a biological destination, comprising:

providing a piston pump having at least one pump chamber, wherein said pump chamber holds a disposable flexible cassette formed from two sheets of flexible material bonded together along a selected bond area to form at least one fluid-containing chamber and particularized open flow paths;

providing a spline piston adjacent to said pump chamber in the piston pump;

wherein advancement of the piston causes fluid to flow from said flexible cassette in the pump chamber to the biological destination, wherein the flow rate of the fluid leaving the pumping chamber is related quadratically to the velocity of the piston and wherein said flow rate is independent of fluid pressure; and

advancing the piston according to a cyclical, time-varying velocity profile that emulates a human heart, wherein advancement of the piston is divided into multiple periods, each period including a first partial cycle at a predefined, controlled lower velocity and a second partial cycle at a predefined, controlled upper velocity, and wherein the predefined upper and lower controlled velocities of the piston correspond to an upper and a lower output flow rate, respectively.

2. The method of claim 1, wherein the velocity of the piston varies according to a rectangle-wave characteristic having a duty cycle.

3. The method of claim 2, further comprising:

receiving user input to specify the duty cycle for the rectangle-wave characteristic.

4. The method of claim 1, further comprising:

selecting the time-varying velocity profile so as to maintain a constant average flow rate.

5. The method of claim 4, wherein selecting the time-varying velocity profile further comprises computing the time-varying velocity profile from a desired amplitude, a desired duty cycle, and a desired average flow rate or pulse pressure.

6. The method of claim 5, wherein the time-varying velocity profile includes an upper flow rate and a lower flow rate, which are computed from the desired amplitude, desired duty cycle, and desired average flow rate or pulse pressure.

7. The method of claim 5, further comprising:

obtaining user input to specify the desired amplitude, desired duty cycle, and desired average flow rate or pulse pressure.

8. The method of claim 1, further comprising:

obtaining user input to specify a frequency for the time-varying velocity profile.

9. The method of claim 1, wherein the fluid pumped from the pump chamber passes through additional at least one additional apparatus before entering the biological destination.

10. The method of claim 9, wherein the at least one additional apparatus includes a compliant fluid delivery line.

11. The method of claim 9, wherein the at least one additional apparatus includes a heat exchanger.

12. The method of claim 1, wherein a flow rate of the fluid pumped from the pump chamber is independent of fluid pressure.

13. The method of claim 12, wherein the organ is a heart.

14. The method of claim 1, wherein the fluid includes at least one of blood, crystalloid solution, cardioplegia solution, and other medication.

15. The method of claim 1, wherein the biological destination is an organ.

16. The method of claim 1, wherein the biological destination is an organism.

17. The method of claim 16, wherein the organism is a human being.

18. The method of claim 1, wherein the piston contains a pressure sensor to determine pressure within the pump chamber.

19. The method of claim 1, further comprising:

selecting the time-varying velocity profile so as to maintain a constant pulse pressure over time.

20. A continuous pulsatile fluid delivery system comprising:

a piston pump having at least one pump chamber, wherein said pump chamber holds a disposable flexible cassette formed from two sheets of flexible material bonded together along a selected bond area to form at least one fluid-containing chamber and particularized open flow paths;

a spline piston adjacent to said pump chamber in the piston pump;

wherein advancement of the piston causes fluid to flow from said flexible cassette in the pump chamber to the biological destination, wherein the flow rate of the fluid leaving the pumping chamber is related quadratically to the velocity of the piston and wherein said flow rate is independent of fluid pressure;

a control system configured to control operation of the piston pump; and

an instruction set implemented in said control system, wherein the instruction set advances the piston according to a cyclical, time-varying velocity profile that emulates a human heart, wherein advancement of the piston is divided into multiple periods, each period including a first partial cycle at a predefined, controlled lower velocity and a second partial cycle at a predefined, controlled upper velocity, and wherein the predefined upper and lower velocities of the piston correspond to an upper and a lower output flow rate, respectively.

21. The fluid delivery system of claim 20, wherein the velocity of the piston varies according to a rectangle-wave characteristic having a duty cycle.

22. The fluid delivery system of claim 21, further comprising:

a user input device, wherein the user input device receives user input to specify the duty cycle for the rectangle-wave characteristic.

23. The fluid delivery system of claim 20, wherein the control system selects the time-varying velocity profile so as to maintain a constant average flow rate.

24. The fluid delivery system of claim 23, wherein selecting the time-varying velocity profile further comprises computing the time-varying velocity profile from a desired amplitude, a desired duty cycle, and a desired average flow rate or pulse pressure.

25. The fluid delivery system of claim 24, wherein the time-varying velocity profile includes an upper flow rate and a lower flow rate, which are computed from the desired amplitude, desired duty cycle, and desired average flow rate or pulse pressure.

26. The fluid delivery system of claim 24, further comprising:

a user input device, wherein the user input device obtains user input to specify the desired amplitude, desired duty cycle, and desired average flow rate or pulse pressure.

27. The fluid delivery system of claim 20, further comprising:

a user input device, wherein the user input device obtains user input to specify a frequency for the time-varying velocity profile.

28. The fluid delivery system of claim 20, wherein the fluid pumped from the pump chamber passes through additional at least one additional apparatus before entering the biological destination.

29. The fluid delivery system of claim 28, wherein the at least one additional apparatus includes a compliant fluid delivery line.

30. The fluid delivery system of claim 28, wherein the at least one additional apparatus includes a heat exchanger.

31. The fluid delivery system of claim 20, wherein a flow rate of the fluid pumped from the pump chamber is independent of fluid pressure.

32. The fluid delivery system of claim 20, wherein the fluid includes at least one of blood, crystalloid solution, cardioplegia solution, and other medication.

33. The fluid delivery system of claim 20, wherein the biological destination is an organ.

34. The fluid delivery system of claim 33, wherein the organ is a heart.

35. The fluid delivery system of claim 20, wherein the biological destination is an organism.

36. The fluid delivery system of claim 35, wherein the organism is a human being.

37. The fluid delivery system of claim 20, wherein the piston contains a pressure sensor to determine pressure within the pump chamber.

38. The fluid delivery system of claim 20, wherein the control system selects the time-varying velocity profile so as to maintain a constant pulse pressure over time.