Systems, devices and methods for cardiopulmonary treatment and procedures

• US 8,105,265 B2
• Filed: 10/10/2008
• Issued: 01/31/2012
• Est. Priority Date: 10/12/2007
• Status: Active Grant

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Demers, Jason A., Gray, Larry B., Dale, James D., Perry, N. Christopher, Altobelli, David E.
• Primary Examiner(s): Deak, Leslie
• Application Number:
  US12/249,668
• Publication Number:
  US 20090099498A1
• Time in Patent Office: 1,208 Days
• Field of Search: 604/4.01, 604/6.09, 604/6.11, 604/6.15, 210/739, 210/741
• US Class Current: 604/6.15
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/362227 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/36223 the cassette being adapted for heating or cooling the blood
• 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 1/362264 the filter being a blood filter
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/3666 Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
• CPC Class Codes: A61M 1/3667 with assisted venous return
• CPC Class Codes: A61M 2205/127 with provisions for heating or cooling
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/427 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/43 using vacuum at the blood pump, e.g. to accelerate filling
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/554 of blood pressure
• CPC Class Codes: G01F 22/02 involving measurement of pressure
• CPC Class Codes: Y10T 137/86035 Combined with fluid receiver

Abstract

A cardiopulmonary bypass system utilizing membrane-based reciprocating positive displacement blood pumps (“pod pumps”). In one aspect, the pod pumps are constructed to provide reduced shear forces on the blood being pumped. In another aspect blood flow through the pod pumps can be controlled by a controller using information from pressure sensors in the control chamber of the pod pumps. In another aspect, the pod pumps are included on a disposable unit that can be received and held by a receptacle means on a base unit, the base unit also providing pressurized control fluid to the pod pumps on the disposable unit through the receptacle means.

Claims

1. An extracorporeal blood flow system comprising:

an air removal container having an upper blood inlet, a lower blood outlet and an air vent near the top of the air removal container, the air vent sealingly connected to, a negative pressure source;

a blood pump having a pump inlet and a pump outlet;

a fluid path from the outlet of the air removal container to the inlet of the blood pump;

a reservoir containing a liquid with a blood inlet and a blood outlet;

a reservoir inlet fluid path branching from the pump outlet and fluidly connected to the inlet of the reservoir;

a reservoir outlet fluid path branching from the pump inlet and fluidly connected to the outlet of the reservoir;

a first valve means to control flow of blood from the reservoir to the pump inlet and a second valve means to control flow of blood from the pump outlet to the reservoir;

a pressure sensor in fluid communication with the air vent, and configured to measure air pressure within the air removal container; and

a controller configured to receive the pressure information from the pressure sensor, and configured to control the valve means, wherein

the controller configured to monitor the air pressure within the air removal container, and control the first and second valve means to cause the liquid from the reservoir to flow into the blood pump upon detection of a change in the air pressure within the air removal container.

2. The system of claim 1, wherein the controller is configured to signal the first valve means to open upon detection of a decrease in pressure measured by the pressure sensor.

3. The system of claim 1, wherein the controller is configured to signal the second valve means to open upon detection of an increase in pressure measured by the pressure sensor.

4. The system of claim 1, further comprising a secondary pump, the secondary pump having an inlet in fluid communication through a third valve means with the reservoir outlet fluid path, and having an outlet in fluid communication through a fourth valve means with the reservoir inlet fluid path.

5. The system of claim 4, wherein the controller is configured to control the first, second, third and fourth valve means and the secondary pump in order to control the flow of blood into or out of the reservoir.

6. The system of claim 4, wherein the blood pump and secondary pump each comprises a reciprocating positive displacement pump, and both pumps are fluidly connected to a common blood outflow path.

7. The system of claim 6, wherein the controller is configured to control the blood pump, the secondary pump and the first, second, third and fourth valve means in order to alternate pump strokes to the common blood outflow path.

8. The system of claim 6, wherein the blood pump, secondary pump, and, the first, second, third and fourth valve means are pneumatically actuated.

9. The system of claim 1, further comprising a liquid volume sensor associated with the reservoir, and capable of transmitting information to the controller relating to the liquid volume in the reservoir, wherein

the controller is configured to control the volume of liquid in the reservoir to within a pre-determined range.

10. The system of claim 1, wherein the reservoir comprises a flexible or collapsible bag.

11. An extracorporeal blood flow system comprising:

an air trap having an upper inlet, a lower outlet and an air vent above the upper inlet, the air vent fluidly connected to a negative pressure source;

a first pump having a pump inlet and a pump outlet, the pump inlet fluidly connected to the lower outlet of the air trap;

a reservoir configured to hold a variable volume of liquid and having a reservoir inlet and a reservoir outlet, the reservoir inlet fluidly connected to the outlet of the pump, and the reservoir outlet fluidly connected to the inlet of the pump;

a first valve configured to control flow of liquid from the reservoir to the pump inlet and a second valve configured to control flow of liquid from the pump outlet to the reservoir, the first and second valves controllable by a controller; and

a pressure sensor in fluid communication with the air vent, and configured to measure air pressure within the air trap, the pressure sensor configured to transmit pressure information to the controller;

wherein

the controller is configured to monitor the air pressure within the air trap, and upon detection of a change in the air pressure within the air trap, the controller configured to control the first and second valves to allow liquid from the reservoir to flow to the inlet of the blood pump or to allow liquid to flow from the outlet of the blood pump to the reservoir.

12. The system of claim 11, wherein the controller is configured to signal the first valve to open upon detection of a decrease in pressure measured by the pressure sensor.

13. The system of claim 11, wherein the controller is configure to signal the second valve to open upon detection of an increase in pressure measured by the pressure sensor.

14. The system of claim 11, further comprising a second pump, the second pump having an inlet in fluid communication through a third valve with the reservoir outlet, and having an outlet in fluid communication through a fourth valve with the reservoir inlet, wherein the third and fourth valves are controllable by the controller.

15. The system of claim 14, wherein the controller is configured to control the first, second, third and fourth valves and the second pump in order to control the liquid flowing into or out of the reservoir.

16. The system of claim 11, further comprising a liquid volume sensor associated with the reservoir, and capable of transmitting information to the controller relating to the liquid volume in the reservoir, wherein

the controller is configured to control the volume of liquid in the reservoir to within a pre-determined range.

17. The system of claim 11, wherein the reservoir comprises a flexible or collapsible bag.

18. The system of claim 11, wherein the first pump and second pump each comprises a reciprocating positive displacement pump, and both pumps are fluidly connected to a common liquid outflow path.

19. The system of claim 18, wherein the controller is configured to control the first and second pumps, and the first, second, third and fourth valves in order to alternate pump strokes to the common liquid outflow path.

20. The system of claim 18, wherein the first and second pumps, and the first, second, third and fourth valves are pneumatically actuated.

21. An extracorporeal blood flow system comprising:

an air trap having an upper inlet, a lower outlet and an air vent above the upper inlet, the air vent fluidly connected to a negative pressure source;

a first pump having a pump inlet and a pump outlet, the pump inlet fluidly connected to the lower outlet of the air trap;

a reservoir configured to hold a variable volume of liquid and having a reservoir inlet and a reservoir outlet, the reservoir inlet fluidly connected to the outlet of the first pump, and the reservoir outlet fluidly connected to the inlet of the first pump;

a first valve configured to control flow of liquid from the reservoir to the first pump inlet and a second valve to control flow of liquid from the first pump outlet to the reservoir, the first and second valves controllable by a controller;

a second pump having an inlet in fluid communication through a third valve with the reservoir outlet and an outlet in fluid communication through a fourth valve with the reservoir inlet, the third and fourth valves controllable by the controller; and

a liquid volume sensor associated with the reservoir and configured to transmit information to the controller relating to the liquid volume in the reservoir;

wherein

the controller is configured to control the volume of liquid in the reservoir to within a pre-determined range.

22. The system of claim 21 further comprising a pressure sensor in fluid communication with the air vent, and capable of measuring air pressure within the air trap, the pressure sensor configured to transmit pressure information to the controller;

wherein

the controller is configured to monitor the air pressure within the air trap, and upon detection of a change in the air pressure within the air trap, the controller can control the first or the second pump, and the first, second, third or fourth valves to allow liquid from the reservoir to flow to the inlet of the first pump or to allow liquid to flow from the outlet of the first pump to the reservoir.