Pulsatile flow system and method

• US 6,058,958 A
• Filed: 11/05/1998
• Issued: 05/09/2000
• Est. Priority Date: 11/05/1998
• Status: Expired due to Term

• Current Assignee: ReliantHeart Inc.
• Original Assignee: MicroMed Technology, Inc (MicroMed Cardiovascular, Inc.)
• Inventors: Benkowski, Robert J., Lynch, Bryan E.
• Primary Examiner(s): Michalsky, Gerald A.
• Application Number:
  US09/187,560
• Time in Patent Office: 551 Days
• Field of Search: 73/168, 137/14, 137/563, 137/565.34, 137/593, 417/137, 417/138, 417/141
• US Class Current: 137/14
• CPC Class Codes: A61M 2209/02 Equipment for testing the apparatus
• CPC Class Codes: A61M 60/117 for assisting the heart, e.g. transcutaneous or external ventricular assist devices
• CPC Class Codes: A61M 60/405 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/427 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/538 Regulation using real-time blood pump operational parameter data, e.g. motor current
• CPC Class Codes: A61M 60/546 of blood flow, e.g. by adapting rotor speed
• CPC Class Codes: A61M 60/554 of blood pressure
• CPC Class Codes: A61M 60/585 User interfaces
• CPC Class Codes: F04F 13/00 Pressure exchangers
• CPC Class Codes: Y10T 137/0396 Involving pressure control
• CPC Class Codes: Y10T 137/85954 Closed circulating system
• CPC Class Codes: Y10T 137/86043 Reserve or surge receiver
• CPC Class Codes: Y10T 137/86381 Head-establishing standpipe or expansion chamber [e.g., surge tanks]

Abstract

The present invention relates to a pulsatile flow system and method. The pulsatile flow system includes a reservoir, a pressure riser and a first fluid passage connected between the reservoir and the pressure riser. The system further includes a device adapted to expel fluid from the reservoir through the first fluid passage to the pressure riser. A second fluid passage is connected between the pressure riser and the reservoir, and is adapted to allow fluid to flow unidirectionally therethrough, from the pressure riser to the reservoir. The pulsatile flow system may be adapted to provide pulsatile fluid flow through a medical device, such as a ventricle assist device or mechanical heart valve, to replicate a heart'"'"'s pumping action for testing the device.

Claims

1. A pulsatile flow system, comprising:

a reservoir;

a pressure riser;

a first fluid passage connected between the reservoir and the pressure riser;

a device adapted to expel fluid from the reservoir through the first fluid passage to the pressure riser; and

a second fluid passage connected between the pressure riser and the reservoir, the second fluid passage adapted to allow fluid to flow unidirectionally therethrough, from the pressure riser to the reservoir.

2. The pulsatile flow system of claim 1, wherein at least one of the first and second fluid passages is adapted to restrict fluid flow to a predetermined rate.

3. The pulsatile flow system of claim 2, wherein at least one of the first and second fluid passages includes a flow restrictor valve.

4. The pulsatile flow system of claim 1, wherein the second flow passage includes a check valve configured to allow unidirectional fluid flow through the second passage, from the pressure riser to the reservoir.

5. The pulsatile flow system of claim 1, further comprising at least one device adapted to measure the level of fluid contained in the reservoir, wherein the device adapted to expel fluid is responsive to the at least one device adapted to measure the fluid level.

6. The pulsatile flow system of claim 1, wherein the device adapted to expel fluid comprises:

an air supply configured to provide pressurized air to fluid contained in the reservoir; and

a control device operable to control the application of the pressurized air to fluid contained in the reservoir so as to expel fluid from the reservoir into the first fluid passage.

7. The pulsatile flow system of claim 6, further comprising at least one level measurement device adapted to determine the level of fluid contained in the reservoir, wherein the control device is responsive to the level measurement device to apply the pressurized air to fluid contained in the reservoir when the fluid reaches a predetermined level.

8. The pulsatile flow system of claim 7, wherein:

the at least one level measurement device comprises at least one trigger coupled to at least one of the reservoir and the pressure riser at a predetermined point, such that the trigger is activated when the fluid level reaches the predetermined point; and

wherein

the control device includes a timer and is operable to, upon activation of the trigger, apply the pressurized air to fluid contained in the reservoir for a predetermined time period as indicated by the timer.

9. The pulsatile flow system of claim 8, wherein the trigger comprises an optical trigger.

10. The pulsatile flow system of claim 7, wherein:

the at least one level measurement device comprises

a first trigger coupled to one of the inlet manifold or the pressure riser at a first predetermined point, such that the first trigger is activated when the fluid level reaches the first predetermined point; and

a second trigger coupled to one of the inlet manifold or the pressure riser at a second predetermined point, such that the second trigger is activated when the fluid level reaches the second predetermined point; and

wherein

the control device is operable to, upon activation of the first trigger, apply pressurized air to fluid contained in the reservoir until the second trigger is activated.

11. The pulsatile flow system of claim 7, wherein:

the at least one level measurement device comprises a fluid level transducer coupled to one of the reservoir or the pressure riser, the fluid level transducer adapted to output a signal to the control device indicating the level of fluid contained within at least one of the reservoir and the pressure riser; and

wherein

the control device is operable to apply pressurized air to fluid contained in the reservoir when the fluid level reaches a first predetermined level until the fluid level reaches a second predetermined level.

12. The pulsatile flow system of claim 6, further comprising a flow transducer adapted to output a signal to the control device indicating the amount of fluid expelled from the reservoir;

wherein

the control device is operable to apply pressurized air to fluid contained in the reservoir until a predetermined amount of fluid is expelled from the reservoir.

13. The pulsatile flow system of claim 6, wherein the control device is further adapted to vent air from the reservoir when fluid enters the reservoir through the fluid return passage.

14. The pulsatile flow system of claim 6, wherein the control device comprises a solenoid.

15. The pulsatile flow system of claim 6, further comprising a vapor barrier situated in the reservoir, the vapor barrier adapted to prevent direct contact between fluid contained in the reservoir and the pressurized air, the vapor barrier configured such that the pressurized air moves the vapor barrier to expel fluid from the reservoir.

16. The pulsatile flow system of claim 15, wherein the vapor barrier comprises a diaphragm.

17. The pulsatile flow system of claim 1, wherein the first fluid passage comprises a plurality of flow passages.

18. The pulsatile flow system of claim 17, further comprising:

a first manifold connected to the reservoir; and

a second manifold connected to the pressure riser;

the first and second manifolds each adapted to couple the plurality of first flow passages between the reservoir and the pressure riser.

19. The pulsatile flow system of claim 1, wherein the first fluid passage is adapted to couple an apparatus through which a pulsatile fluid flow is desired between the reservoir and the pressure riser, so as to establish a flow path through the apparatus from the reservoir to the pressure riser.

20. The pulsatile flow system of claim 19, wherein the apparatus comprises a ventricle assist device.

21. The pulsatile flow system of claim 19, wherein the apparatus comprises a valve.

22. The pulsatile flow system of claim 19, wherein the first fluid passage comprises:

an inlet passage having a first end connected to the reservoir, and a second end adapted to be coupled to an inlet of the ventricle assist device; and

an outlet passage having a first end coupled to the pressure riser, and a second end adapted to be coupled to an outlet of the ventricle assist device.

23. The pulsatile flow system of claim 22, further comprising at least one pressure sensor situated on at least one of the inlet or outlet passage.

24. The pulsatile flow system of claim 23, wherein the at least one pressure sensor comprises first and second pressure sensors;

the first and second sensors being situated on the inlet and outlet passages, respectively.

25. A pulsatile flow system, comprising:

a reservoir;

a pressure riser;

first means for connecting at least one ventricle assist device between the reservoir and the pressure riser so as to establish a flow path therethrough;

second means for expelling fluid from the reservoir through the first fluid passage to the pressure riser; and

a second fluid passage connected between the pressure riser and the reservoir, the second fluid passage including third means for allowing unidirectional flow therethrough, from the pressure riser to the reservoir.

26. The pulsatile flow system of claim 25, wherein the second means includes means for controlling the expulsion of fluid from the reservoir.

27. The pulsatile flow system of claim 25, wherein the second fluid passage includes means for regulating fluid flow rate therethrough.

28. A method of providing a pulsatile fluid flow, comprising:

applying a force to fluid contained in a reservoir to expel fluid from the reservoir through a first flow passage to a pressure riser containing fluid, such that the level of the fluid contained in the pressure riser increases;

preventing fluid flow through a second flow passage between the pressure riser the reservoir;

removing the force from the fluid contained in the reservoir; and

permitting fluid flow through the second flow passage from the pressure riser to the reservoir.

29. The method of claim 28, wherein applying a force comprises applying pressurized air.

30. The method of claim 28, wherein preventing return flow comprises closing a check valve.

31. The method of claim 30, wherein applying a force to fluid contained in a reservoir to expel fluid from the reservoir further causes the check valve to close.

32. A method of life testing a ventricle assist device including an inlet and an outlet, comprising:

connecting the inlet to a reservoir containing fluid;

connecting the outlet to a pressure riser containing fluid;

applying a force to the fluid in the reservoir to expel fluid from the reservoir, through the ventricle assist device, to the pressure riser;

preventing fluid flow from the pressure riser to the reservoir through a return passage;

removing the force from the fluid in the reservoir; and

permitting fluid flow through the return passage from the pressure riser to the reservoir.

33. The method of claim 32, wherein applying a force to the fluid in the reservoir comprises applying a force to the fluid in the reservoir to expel fluid from the reservoir, through the ventricle assist device, to the pressure riser so as to increase the outlet pressure from about 80 mm Hg to about 120 mm Hg.