Integrated blood handling system having active gas removal system and methods of use

• US 6,730,267 B2
• Filed: 02/09/2001
• Issued: 05/04/2004
• Est. Priority Date: 02/09/2001
• Status: Expired due to Fees

• Current Assignee: ARG Medical Solutions LLC
• Original Assignee: Cardionet Incorporated
• Inventors: Afzal, Thomas A., Farhangnia, Mehrdad, Hultquist, Kevin L., Stringer, Steven K., Culp, James M., Brian, Ben F. III, Dueri, Jean-Pierre, Linker, Fred I.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Bianco, Patricia
• Application Number:
  US09/780,923
• Publication Number:
  US 20020110485A1
• Time in Patent Office: 1,180 Days
• Field of Search: 422/44-48, 604/4.01, 604/6.09, 604/6.11, 210/739, 210/741, 210/348-51, 210/416.1, 210/418, 210/483, 210/497-501, 210/501--, 210/542, 210/407, 210/321.6, 210/321-2-, 210/321-4-, 210/323.1, 210/383, 210/645, 128/DIG.3, 261/19, 261/24, 261/26, 261/28-30, 261/5, 261/DIG.28, 261/83-85, 261/87, 261/106, 261/109, 261/110, 96/4--6, 96/10, 96/11, 962/34, 962/40, 962/43, 963/73--74, 963/55, 961/55, 961/56, 961/74, 961/81, 962/44, 964/17, 964/21--22
• US Class Current: 422/45
• CPC Class Codes: A61M 1/262 rotating
• CPC Class Codes: A61M 1/267 used for pumping
• CPC Class Codes: A61M 1/3603 in the same direction
• CPC Class Codes: A61M 1/3606 Arrangements for blood-volume reduction of extra-corporeal circuits
• CPC Class Codes: A61M 1/3623 Means for actively controlling temperature of blood
• CPC Class Codes: A61M 1/3626 Gas bubble detectors
• CPC Class Codes: A61M 1/3627 Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 1/3666 Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
• CPC Class Codes: A61M 60/109 incorporated within extracorporeal blood circuits or systems
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/232 Centrifugal pumps
• CPC Class Codes: A61M 60/38 Blood oxygenation
• CPC Class Codes: A61M 60/40 Details relating to driving
• CPC Class Codes: A61M 60/818 Bearings
• CPC Class Codes: F04D 9/006 by venting gas or using gas valves
• CPC Class Codes: Y10S 261/28 Blood oxygenators

Abstract

Apparatus and methods for pumping and oxygenating blood are provided that include a gas removal system. An integrated blood processing unit is provided in which a gas removal/blood filter, pump and blood oxygenation element are mounted within a common housing. The gas removal system includes a sensor mounted on the housing to sense the presence of gas, and a valve is operably coupled to the sensor to evacuate gas from the system when the sensor detects an accumulation of gas.

Claims

1. Apparatus for oxygenating and pumping blood comprising:

a housing having a blood inlet, a blood outlet, a gas collection plenum, an annular fiber bundle compartment, and a pump space, the blood inlet in fluid communication with the gas collection plenum, the pump space coupled in fluid communication with the gas collection plenum by a central void defined by an interior wall of the annular fiber bundle compartment, and in fluid communication with the annular fiber bundle compartment, the blood outlet coupled to annular fiber bundle compartment;

a filter disposed within the gas collection plenum in communication with the central void, the filter adapted to remove gas entrained within blood introduced into the gas collection plenum;

an annular fiber bundle disposed within the annular fiber bundle compartment;

a pump disposed within the pump space; and

a sensor disposed on the housing and adapted to detect the presence of gas within the gas collection plenum.

2. The apparatus of claim 1 further comprising a controller that controls operation of the apparatus responsive to an output of the sensor.

3. The apparatus of claim 2 further comprising:

a line adapted to be coupled to a suction source; and

a valve coupled to the line between the housing and the suction source,

wherein the valve is operated responsive to the controller.

4. The apparatus of claim 1 wherein the annular fiber bundle is disposed surrounding the central void.

5. The apparatus of claim 1 wherein the filter element is disposed at least partially in the central void.

6. The apparatus of claim 5 wherein the filter element further comprises at least one baffle.

7. The apparatus of claim 1 wherein the filter element is disposed at an inlet to the central void, the filter element comprising a pleated material.

8. The apparatus of claim 1 wherein the annular fiber bundle compartment includes a blood inlet manifold and a blood outlet manifold, and the blood inlet manifold is disposed on a diametrically opposite side of the housing from the blood outlet manifold.

9. The apparatus of claim 8 wherein the pump comprises a plurality of vanes.

10. The apparatus of claim 1, further comprising a heat exchanger mounted to the housing.

11. The apparatus of claim 1 further comprising a filter element disposed at an inlet to the central void, the filter element comprising a pleated material.

12. Apparatus for oxygenating and pumping blood comprising:

a housing defining a blood flow path including, in series, a gas collection plenum, a pump space and oxygenator compartment;

a blood oxygenation element disposed within the oxygenator compartment;

a pump disposed in the pump space, the pump configured to draw blood from the gas collection plenum and to propel blood from the pump space through the blood oxygenation element;

a sensor disposed on the housing to sense the presence of gas in the gas collection plenum; and

a controller coupled to the sensor, the controller programmed to evacuate gas from the gas collection plenum responsive to an output of the sensor.

13. The apparatus of claim 12 wherein the pump is mounted within the housing below the blood oxygenation element.

14. The apparatus of claim 13, wherein the pump comprises a plurality of vanes.

15. The apparatus of claim 14 further comprising a filter element disposed at least partially in the central void.

16. The apparatus of claim 15 wherein the filter element further comprises at least one baffle.

17. The apparatus of claim 12 wherein the housing includes an inlet manifold and an outlet manifold, the inlet manifold extending along a first side of the housing and the outlet manifold extending along a diametrically opposite side of the housing.

18. The apparatus of claim 17 wherein the housing further includes a relief area on an interior wall of the housing opposite to at least one of the inlet manifold and the outlet manifold.

19. The apparatus of claim 12 further comprising:

a line adapted to be coupled to a suction source; and

a valve coupled to the line between the housing and the suction source,

wherein the valve is operated responsive to the controller.

20. Apparatus for oxygenating and pumping blood comprising:

a housing defining a blood flow path having a blood inlet, a gas collection plenum, a pump space, an oxygenator compartment, and a blood outlet;

a filter disposed within the gas collection plenum to remove gas entrained within blood introduced into the gas collection plenum;

an oxygenation element disposed within the oxygenator compartment;

a pump disposed within the pump space, the pump configured to draw blood from the blood inlet to the pump space through the gas collection plenum, and to propel blood from the pump space through the oxygenation element to the blood outlet; and

a sensor disposed on the housing to sense the presence of gas within the gas collection plenum.

21. The apparatus of claim 20 further comprising a controller that controls operation of the apparatus responsive to an output of the sensor.

22. The apparatus of claim 21 further comprising:

a vent port in fluid communication with the gas collection plenum; and

an actuator coupled to the vent port,

wherein the controller intermittently actuates the actuator to evacuate gas collected in the gas collection plenum.

23. The apparatus of claim 20 wherein the oxygenation element comprises an annular fiber bundle.

24. The apparatus of claim 20 wherein the housing further defines a central void that couples the gas collection plenum to the pump space, and the filter element is disposed at least partially in the central void.

25. The apparatus of claim 24 wherein the filter element further comprises at least one baffle.

26. The apparatus of claim 24 wherein the filter element is disposed at an inlet to the central void, the filter element comprising a pleated material.

27. The apparatus of claim 20 wherein the oxygenator compartment includes a blood inlet manifold and a blood outlet manifold, and the blood inlet manifold is disposed on a diametrically opposite side of the housing from the blood outlet manifold.

28. The apparatus of claim 20 wherein the pump comprises a plurality of vanes.

29. The apparatus of claim 20 further comprising a heat exchanger mounted to the housing.