Automated means to remove air from venous blood during CPB

• US 7,131,966 B1
• Filed: 08/09/2004
• Issued: 11/07/2006
• Est. Priority Date: 08/28/1998
• Status: Expired due to Term

• Current Assignee: Yehuda Tamari
• Original Assignee: Yehuda Tamari
• Inventors: Tamari, Yehuda
• Primary Examiner(s): Bianco, Patricia
• Application Number:
  US10/915,000
• Time in Patent Office: 820 Days
• Field of Search: 422 44- 48, 604/4.01, 604/5.01, 604/6.01, 604/6.1, 604/6.07, 604/7, 604/6.09, 604/6.11, 604 614- 616, 604403-411, 604/317, 604/327, 604319-324, 604/132, 604/151, 604/153, 604/246, 604/249, 128/DIG.3
• US Class Current: 604/406
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3627 Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 1/3667 with assisted venous return
• CPC Class Codes: Y10S 128/03 Heart-lung

Abstract

Venous reservoirs are interposed between the patient and the arterial pump and serve to remove air bubbles and provide compliance that accommodates variations in the volume of blood circulating in the extracorporeal circuit during cardiopulmonary bypass (CPB). The invention is a reservoir that incorporates automated means to remove air bubbles from the venous line prior to the blood entering the arterial blood pump. In another form, the reservoir includes means that handles foam prior to the blood entering the blood pump. In yet another form, the invention is means that improve air removal in a soft shell venous reservoir. These features are applicable to CPB circuits using gravity drainage or vacuum assisted venous drainage.

Claims

1. An apparatus to trap and remove air bubbles in a venous side of a cardiopulmonary bypass circuit, said apparatus comprising;

a) a blood chamber having an inlet, an outlet and an air venting port to remove air entering the blood chamber;

b) automated means to detect air in venous blood and provide a signal to alarm the user of the presence of air;

c) a suction means to remove air from the blood chamber;

wherein the alarm signal is used to automatically control the suction means to remove air from the venous blood in the blood chamber.

2. The apparatus of claim 1, wherein the suction means removes air but not blood from the blood chamber.

3. The apparatus of claim 1, wherein the suction means is provided by a roller pump.

4. The apparatus of claim 1, wherein the suction means is provided by wall suction in the operating room.

33. The apparatus of claim 1, wherein the suction means removes all the air while limiting blood loss from the blood chamber.

34. The apparatus of claim 1, further comprising means that limit blood loss from the blood chamber via the purge port.

35. The apparatus of claim 34, wherein means that limit blood loss is includes achieved by maintaining air at the top of the blood chamber.

36. The apparatus of claim 34, wherein means that limit blood loss is include a blood-to-air-interface at the top of the blood chamber.

37. The apparatus of claim 34, wherein means that limit blood loss consists of breaking up blood foam into blood liquid.

38. The apparatus of claim 36 wherein the means to limit blood loss is a defoamer that provides a defoaming action above the blood-to-air-interface.

5. A method to trap and remove air bubbles in the venous side of a cardiopulmonary bypass circuit, said method comprising;

a) detecting air in the venous side and providing a signal to alarm the user of the presence of air;

b) removing air from a blood chamber in the venous side; and

automatically controlling a suction means to remove air from the venous side of the blood chamber.

6. The method of claim 5, wherein the removing step removes air but not blood from the blood chamber.

7. The method of claim 5, wherein the suction means is provided by a roller pump.

8. The method of claim 5, wherein the suction means is provided by wall suction in the operating room.

39. The method of claim 5, further comprising means that limit blood loss from the blood chamber via the purge port.

40. The method of claim 39, wherein blood loss is limited by maintaining a blood-to-air-interface at the top of the blood chamber.

41. The method of claim 39, wherein blood loss is limited by breaking up of blood foam, that forms by the venous air bubbling through blood, into blood liquid.

42. A method of claim 41 wherein the blood foam breaking up into blood liquid occurs between the suction means and the blood-to-air-interface.

9. An apparatus to trap and remove air in the blood on the venous side of a cardiopulmonary bypass circuit, said apparatus comprising:

a) a blood chamber having an inlet and an outlet;

b) an air purging port located for removing air entering the blood chamber; and

c) suction means for automatically removing the air from the blood chamber;

wherein a fluid path between the blood chamber and the suction means is unhindered by the blood.

10. The apparatus of claim 9, wherein the suction means is configured to remove air but little or no blood from the blood chamber.

11. The apparatus of claim 10, wherein the suction means comprises a roller pump.

12. The apparatus of claim 10, wherein the suction means comprises wall suction in the operating room.

13. The apparatus of claim 9, further comprises a vacuum regulator interposed between the blood chamber and the suction means.

14. The apparatus of claim 13, wherein further the blood chamber has a minimum acceptable blood level having a first height above a bottom of the blood chamber, and further having a chimney that extends above a top of the blood chamber by a height equal to at least the first height, and wherein suction applied to the chimney is controlled to pull the blood up into the chimney and maintain the blood in the chimney, thereby removing air that enters the chimney.

15. The apparatus of claim 9, wherein the suction means is configured to maintain air-to-blood interface between the suction means and the blood chamber.

16. The apparatus of claim 9, wherein the controlled suction means comprises a valve that opens to apply suction to a top of the blood chamber to remove air from the top of the blood chamber and closing once at least some of the air has been removed.

17. The apparatus of claim 9, further comprising a one way valve placed between a top of the blood chamber and the suction means.

29. The apparatus of claim 16, wherein the valve prevents the blood from exiting the top of the blood chamber.

18. A method to trap and remove air bubbles from the venous side of a cardiopulmonary bypass circuit, said method comprising:

a) introducing venous blood into a closed blood chamber through an inlet;

b) allowing the air from the venous blood to rise to the top of the blood chamber;

c) providing a blood-to-air-interface in the blood chamber;

d) automatically suctioning the air from the air side of the blood-to-air-interface.

19. The method of claim 18, wherein the blood-to-air-interface minimizes blood loss from the blood chamber when the air is removed from the chamber.

20. The method of claim 18, further comprising means that reduce blood loss from the blood chamber when the air is removed from the blood chamber.

21. The method of claim 18, further comprising means to break up blood foam into blood liquid and thereby reduce blood loss from the blood chamber.

22. A method of claim 21 wherein the means to break up blood foam is a defoamer that provides a defoaming action above the blood-to-air-interface while limiting contact between the defoamer and the blood in the blood chamber.

30. The method of claim 18, wherein the blood-to-air-interface assures that blood from the blood chamber does not exit the blood chamber.

66. The method of claim 18 that further includes placing a screen between the inlet and outlet of the blood chamber, wherein the screen inhibits air entering the inlet of the blood chamber from reaching the outlet of the blood chamber.

23. An apparatus to trap and remove air bubbles in the venous side of a cardiopulmonary bypass circuit, said apparatus comprising:

a) a blood chamber in the venous side having an inlet, an outlet, and an air purging port located at a top of the blood chamber and used to remove air entering the blood chamber;

b) a suction source for removing the air at the top of the blood chamber; and

c) a valve, placed between the top of the chamber and the suction source, said valve opening to remove air from the blood chamber and closing once air has been removed.

24. The apparatus of claim 23, wherein the suction source comprises a suction regulator.

25. A method for automatically removing air from venous blood during cardiopulmonary bypass comprising:

a) having venous blood flow into a closed blood chamber through an inlet port, and out through an outlet port;

b) maintaining a first blood level in the blood chamber;

c) letting air in the venous blood rise to a portion of the blood chamber to displace the blood and lower the level of the blood from the first blood level; and

d) applying controlled suction to automatically remove air from the portion of the blood chamber.

26. An apparatus to trap and remove air in the venous side of a cardiopulmonary bypass circuit, said apparatus comprising;

a) a blood chamber in the venous side having an inlet, an outlet and an air purging port located at a top of the blood chamber;

b) a suction means to remove the air from the top of the blood chamber; and

c) a valve placed between the top of the blood chamber and the suction means;

wherein when air enters the top of the blood chamber, the valve automatically opens, applying suction to the top of the blood chamber and removing the air from the blood chamber.

28. The apparatus of claim 26, wherein the valve prevents blood from exiting the top of the blood chamber.

27. An apparatus to trap and remove air in the venous side of a cardiopulmonary bypass circuit, said apparatus comprising:

a) a blood chamber in the venous side having a an inlet and an outlet;

b) an air purging port located for removing air entering the blood chamber;

c) suction means for automatically removing the air from the blood chamber; and

d) a fluid path between blood in the blood chamber and the suction means having an inside diameter between 1/32″ and

1″

,

wherein when air enters the top of the blood chamber, the suction means automatically apply suction to the top of the blood chamber and remove at least some of the air from the blood chamber.

31. The combination of an apparatus to trap and remove air in the venous side of a cardiopulmonary bypass circuit and a blood trap, said combination comprising:

a) a blood chamber in the venous side having a an inlet and an outlet;

b) an air purging port located for removing air entering the blood chamber;

c) suction means for automatically removing the air from the blood chamber; and

d) a blood trap interposed between the suction means and the air purging port;

wherein blood that exits the air purging port is trapped by the blood trap and may be returned to the patient thereby reducing blood loss.

32. The combination of claim 31, wherein the blood trap is a cardiotomy reservoir.

43. The combination of claim 32, wherein suction applied to the blood chamber is also applied to the cardiotomy reservoir.

44. A method to continuously trap and automatically remove air in the venous side of a cardiopulmonary bypass circuit, the method comprising:

a. placing a blood chamber having a top, an inlet, an outlet and an air purging port in the venous side of the cardiopulmonary bypass circuit;

b. trapping venous air in the blood chamber;

c. providing a suction means; and

d. providing a mean that respond to air in the blood chamber said response resulting in the application of suction to the top of the blood chamber when air is present and stopping the suction when at least some air has been removed from the blood chamber;

wherein the application and stopping of suction in response to air in the chamber automatically remove air in the venous side of the cardiopulmonary bypass circuit.

45. The method of claim 44, wherein the suction removes all the air while limiting blood loss from the blood chamber.

46. The of claim 44, further comprising means that limit blood loss from the blood chamber via the purge port.

47. The method of claim 46, wherein means that limit blood loss include maintaining air at the top of the blood chamber.

48. The method of claim 46, wherein the means that limit blood loss include maintaining a blood-to-air-interface at the top of the blood chamber.

49. The method of claim 46, wherein the means that limit blood loss include breaking up blood foam into blood liquid, said blood liquid remaining in the blood chamber.

50. The method of claim 49 wherein the means to limit blood loss is a defoamer that provides a defoaming action.

51. A method of claim 49 wherein the blood foam breaking up into blood liquid occurs between the suction means and the blood-to-air-interface.

52. The method of claim 50 wherein the defoamer is located between the blood-to-air-interface and the suction means.

53. The method of claim 44 that further includes a cardiotomy reservoir wherein the suction applied to the blood chamber is also applied to the cardiotomy reservoir.

54. The method of claim 44, that further includes means that inhibit air entering the inlet of the chamber from exiting the chamber.

55. The method of claim 54, wherein the means that inhibit air entering the inlet of the chamber from exiting the chamber is a screen placed between the inlet and outlet of the blood chamber.

56. The method of claim 44, wherein that further includes that maintain blood-to-air interface at the top of the blood chamber.

57. A method to trap and automatically remove air in the venous side of a cardiopulmonary bypass circuit, the method comprising:

a. having venous blood flow through a blood chamber having a top, an inlet, an outlet and an air purging port;

b. providing a suction means; and

c. applying suction to the top of the blood chamber when air is present in the blood chamber to remove air from the top of the chamber and stopping the suction when at least some of that air has been removed;

wherein the application and removal of the suction in response to the air in the chamber automatically removes air in the venous side of the cardiopulmonary bypass circuit.

58. The method of claim 57, that further includes a screen placed between the inlet and outlet of the blood chamber, wherein the screen inhibits air entering the inlet of the chamber from exiting the outlet of the blood chamber.

59. The method of claim 58, that wherein the screen facilitates the upward motion of air entering the blood chamber upward towards air purging port.

60. An apparatus to trap and automatically remove air in the venous side of a cardiopulmonary bypass circuit, the apparatus comprising:

a. a blood chamber that traps the air in the venous blood, said chamber having a top, an inlet, an outlet, an air purging port;

b. a suction means connected to the air purging port;

c. a mean that responds to the air in the blood chamber said response resulting in suction applied to the top of the blood chamber when air is present and stopping the suction when at least some of the air has been removed from the blood chamber;

wherein the application and removal of the suction in response to the air in the chamber automatically remove air in the venous side of the cardiopulmonary bypass circuit.

61. The apparatus of claim 60, that further includes a screen placed between the inlet and outlet of the blood chamber, wherein the screen inhibits air entering the inlet of the blood chamber from exiting the outlet of the blood chamber.

62. The apparatus of claim 61, that wherein further the screen diverts air entering the blood chamber upward towards air purging port.

63. The apparatus of claim 60, further comprising means to break up blood foam into blood liquid and thereby reduce blood loss from the blood chamber.

64. The apparatus of claim 63 wherein the means to break up blood foam is a defoamer.

65. A method to trap and remove air in the venous side of a cardiopulmonary bypass circuit, said method comprising:

a) providing a blood chamber having an inlet, an outlet, a top, and an air venting port to remove air entering the blood chamber and means that inhibit air entering the inlet of the chamber from reaching the outlet of the chamber;

b) directing venous blood flow into the inlet of and out of the outlet of the blood chamber;

c) providing a suction means to remove air from the blood chamber via the air venting port of the blood chamber;

wherein the application and removal of the suction in response to the air in the chamber automatically remove air in the venous side of the cardiopulmonary bypass circuit.