Blood/gas separator and flow system

• US 5,049,146 A
• Filed: 05/31/1989
• Issued: 09/17/1991
• Est. Priority Date: 05/31/1989
• Status: Expired due to Fees

• Current Assignee: Jostra Bentley, Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Bell, R. Scott, Bringham, Richard L.
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): Owens, Kerry
• Application Number:
  US07/359,178
• Time in Patent Office: 839 Days
• Field of Search: 422/47, 604/408, 604/409, 604/410, 604/4, 604/5, 604/6, 128/DIG. 3
• US Class Current: 604/6.09
• CPC Class Codes: A61M 1/325 Surfactant coating; Improving wettability
• CPC Class Codes: A61M 1/3627 Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 1/3632 Combined venous-cardiotomy reservoirs
• CPC Class Codes: Y10S 128/03 Heart-lung

Abstract

A blood reservoir is formed with a hard outer shell housing defining at least one blood compartment. A flexible bag is mounted in the outer shell and is connected to the reservoir inlet port to allow blood to directly enter the flexible bag. The bag includes two oppositely positioned ends, one of which includes a mircoporous screen and is situated to lie partially below a minimum level attained by blood in the reservoir. The second bag end is substantially open, and includes a porous element partially coated with an antifoaming agent. The coated portion of the element is positioned above a maximum level attained by the blood in the hard shell. The potential of excessive mixing between the blood and air is reduced by controlling the expansion of the bag during blood flow.

Claims

1. A venous and cardiotomy blood reservoir comprising:

a housing defining at least two separate compartments, with a second of said compartments being positioned above the first of said compartments, said housing including separate inlet and outlet ports communicating respectively with each of said compartments;

connecting means coupled to said inlet ports of a first of said compartments and said outlet ports of a second of said compartments;

a flexible bag means positioned in said housing first compartment for receiving blood through said inlet ports of said first compartment, said bag means being securely mounted in said compartment to restrict expansion of said bag means as said blood enters through said inlet ports, said bag means having a first end including a porous screen through which blood flows out of said bag means, and a second opposite end including a porous defoamer means which is at least partially coated with an antifoam material, with said partially coated portion being positioned above a maximum blood level in said reservoir;

a porous element positioned in said second compartment between said inlet and outlet ports, said porous element being coated with an antifoaming material;

a plate mounted in said housing to which said bag means is securely mounted along its edges;

said first bag means end being positioned at a level to lie partially below a minimum blood level in said reservoir;

said bag means being an elongated flexible bag which is mounted in said housing with said first end being positioned horizontally below said second end;

said screen having a porosity of from about forty to about two hundred microns;

said porous defoamer means having a porosity of from about four hundred to about eighteen hundred microns; and

said connecting means comprising a tube fitting means which connects to said inlet port of said first compartment and a flexible tubing connected to said tube fitting means and said outlet port of said second compartment.

2. The blood reservoir of claim 1 wherein said tube fitting means is positioned in relation to said first compartment inlet means to limit the introduction of air into said first compartment.

3. The reservoir of claim 2 wherein bag means is fixed in said compartment to define a blood flow path traversing downward from said inlet to said outlet, whereby blood entering through said inlet travels under the influence of gravity to said outlet.

4. The reservoir of claim 3 further including means for mounting the reservoir to a stand, said mounting means orientating a forward facing wall of said reservoir at an angle to the floor upon which said stand rests allowing for examination of the contents of the reservoir.

5. The reservoir of claim 4 wherein said reservoir is mounted to a stand to position a forward wall of the reservoir at an angle of from about 60°

to about 85°

to said floor.

6. The reservoir of claim 4 wherein said reservoir is mounted to a stand to position a forward wall of the reservoir at an angle of about 70°

to said floor.

7. A cardiotomy and venous blood reservoir device comprising:

a rigid housing defining an upper compartment and a lower compartment therewithin;

said upper compartment having a cardiotomy blood inlet, a cardiotomy blood outlet and a cardiotomy blood filter element disposed therein between the cardiotomy blood inlet and the cardiotomy blood outlet such that cardiotomy blood entering the upper compartment through the cardiotomy blood inlet will pass through said cardiotomy filter element prior to exiting the upper compartment through the cardiotomy blood outlet;

said lower compartment having a flexible bag positioned therewithin, said flexible bag having a top end, a bottom end, a blood inlet, a blood outlet and a microporous screen element positioned between the blood inlet and the blood outlet such that blood entering the flexible bag through the blood inlet will pass through the microporous screen element prior to exiting the flexible bag through the blood outlet;

the blood outlet of the flexible bag positioned within the lower compartment being located such that blood passing out of said blood outlet will collect inside of said lower compartment outside of said flexible bag;

a blood outlet port formed in the bottom of the lower compartment below the bottom of said flexible bag to permit blood passing out of the flexible to subsequently drain out of the lower compartment.

8. The device of claim 7 wherein the cardiotomy filter element disposed within said upper compartment comprises:

a porous filter element formed around and defining an inner blood receiving space adjacent said cardiotomy inlet such that blood flowing in the cardiotomy inlet will enter the inner blood receiving space and will subsequently pass outwardly through said porous filter element.

9. The device of claim 8 wherein said porous filter element comprises a polyester felt material.

10. The device of claim 7 further comprising:

a defoamer element mounted within the upper chamber and interposed between the cardiotomy blood inlet and the cardiotomy blood outlet such that cardiotomy blood entering the upper chamber through the cardiotomy inlet will pass through the defoamer element prior to exiting the upper chamber through the cardiotomy blood outlet.

11. The device of claim 10 wherein said defoamer element comprises a quantity of porous foam material containing a chemical antifoam agent.

12. The device of claim 10 wherein said defoamer element and said porous filter element are both configured and disposed about an inner blood receiving space adjacent said cardiotomy blood inlet such that cardiotomy blood flowing in the cardiotomy blood inlet will initially pass into said inner blood receiving space and will subsequently pass outwardly through the defoamer element and the porous filter element.

13. The device of claim 10 wherein said defoamer element has a pore size of approximately 400-1800 microns.

14. The device of claim 10 wherein said defoamer element is formed of porous polyurethane foam.

15. The device of claim 7 wherein the flexible bag is positioned within the lower compartment such that blood exiting the outlet of the flexible bag will enter the lower compartment, outside of the flexible bag prior to passing out of the lower compartment through said blood outlet port.

16. The device of claim 7 wherein a minimum operational blood level in the lower compartment is known and wherein:

the flexible bag is positioned within the lower compartment such that the blood outlet of the flexible bag is beneath the minimum blood level in said lower compartment.

17. The device of claim 7 further comprising a plate mounted in the lower compartment to which said flexible bag is mounted.

18. The device of claim 17 wherein said plate is positioned in spaced relation to a first portion of said rigid housing and wherein said flexible bag is positioned between said plate and said first portion of the rigid housing such that expansion of said flexible bag is limited to the space existing between said plate and said portion of said rigid housing.

19. The device of claim 18 wherein the first portion of the rigid housing is the rearward wall of the lower compartment such that the bag is disposed between said plate and said rearward wall.

20. The device of claim 7 wherein the microporous screen element has a pore size of approximately 40-200 microns.

21. The device of claim 7 wherein:

the top end of said flexible bag is open; and

a second porous defoamer element is disposed within the top end of flexible bag such that foam rising within the flexible bag will contact said defoamer element prior to flowing out of the open top end of the flexible bag.

22. The device of claim 21 wherein said second porous defoamer element comprises:

at least a first mass of porous foam material positioned inside the flexible bag, adjacent the open top end thereof.

23. The device of claim 21 wherein said second porous defoamer element further comprises:

at least a second mass of porous foam material disposed outside of said flexible bag near the open top end thereof.

24. The device of claim 7 wherein the portion of said rigid housing defining said lower compartment comprises a forward wall and a rearward wall, opposing said forward wall, said forward wall and said rearward wall being closest to one another at the bottom end of said lower compartment and diverging away from one another thereabove.

25. The device of claim 24 wherein said device is mountable on a stand above a generally horizontal underlying floor such that the forward wall of the lower compartment is disposed at an angle of about 60-85 degrees relative to the underlying floor.

26. The device of claim 25 wherein the forward wall of the lower compartment is disposed at an angle of approximately 70 degrees relative to the underlying floor.

27. The device of claim 7 wherein said rigid housing is formed of clear plastic.

28. The device of claim 27 wherein a gradient scale is formed on the forward wall of the lower compartment to permit measurement of the level of blood within said lower compartment.

29. The device of claim 7 further comprising:

a connector for concomitantly fluidly connecting the blood inlet of the flexible bag within the lower compartment to (a) the cardiotomy blood outlet of the upper compartment and (b) a separate venous return source, thereby permitting filtered cardiotomy blood from the upper compartment to combine with venous return blood passing into said flexible bag.

30. The device of claim 7 further comprising:

a first tube connecting the cardiotomy blood outlet of the upper compartment to the blood inlet of the flexible bag such that filtered cardiotomy blood will flow from the upper compartment into the flexible bag within said lower compartment.

31. The device of claim 7 wherein said flexible bag comprises an elongate bag and wherein said blood inlet is formed below the top end of the bag and said blood outlet is formed near the bottom end of the bag.

32. The device of claim 31 wherein a minimum operational blood level within the lower compartment is known and wherein said flexible bag is positioned within the lower compartment such that the blood outlet of the flexible bag is below the known minimum operational blood level within the lower compartment.

56. The device of claim 26 wherein:

the blood outlet of the flexible bag is located such that blood passing out of said blood outlet will collect inside of said lower compartment and outside of said flexible bag.

57. The device of claim 56 wherein a minimum operational blood level within the lower compartment is known and wherein said flexible bag is positioned within the lower compartment such that the blood outlet of the flexible bag is below the known minimum operational blood level within the lower compartment.

33. A blood reservoir device for receiving, filtering and combining cardiotomy blood and venous return blood in an extracorporeal blood oxygenation circuit, said device comprising:

a rigid housing defining an upper compartment and a lower compartment therewithin;

a cardiotomy blood inlet and a cardiotomy blood outlet formed in the upper compartment;

a cardiotomy blood filter disposed within the upper compartment between the cardiotomy blood inlet and cardiotomy blood outlet such that blood entering the cardiotomy blood inlet will pass through the filter prior to exiting the upper compartment through the cardiotomy blood outlet;

a flexible bag disposed within the lower compartment, said flexible bag having a top end, a bottom end, a blood inlet, a blood outlet and a microporous screen element positioned between the blood inlet and the blood outlet such that blood entering the flexible bag through the blood inlet will pass through the microporous screen element prior to exiting the flexible bag through the blood outlet;

the blood inlet of the flexible bag being fluidly connected to the cardiotomy blood outlet of the upper compartment and concurrently fluidly connectable to a source of venous return blood such that filtered cardiotomy blood from the upper compartment may combine with venous return blood within the flexible bag; and

a blood outlet port formed in said lower compartment to permit blood which exits the flexible bag and collects outside of said flexible bag to subsequently pass out of said lower compartment.

34. The device of claim 33 wherein the cardiotomy filter element disposed within said upper compartment comprises:

a porous filter element formed around and defining an inner blood receiving space adjacent said cardiotomy inlet such that blood flowing in the cardiotomy inlet will enter the inner blood receiving space and will subsequently pass outwardly through said porous filter element.

35. The device of claim 34 wherein said porous filter element comprises a polyester felt material.

36. The device of claim 33 further comprising:

a defoamer element mounted within the upper chamber and interposed between the cardiotomy blood inlet and the cardiotomy blood outlet such that cardiotomy blood entering the upper chamber through the cardiotomy inlet will pass through the defoamer element prior to exiting the upper chamber through the cardiotomy blood outlet.

37. The device of claim 36 wherein said defoamer element comprises a quantity of porous foam material containing a chemical antifoam agent.

38. The device of claim 36 wherein said defoamer element and said porous filter element are both configured and disposed about an inner blood receiving space adjacent said cardiotomy blood inlet such that cardiotomy blood flowing in the cardiotomy blood inlet will initially pass into said inner blood receiving space and will subsequently pass outwardly through the defoamer element and through the porous filter element.

39. The device of claim 36 wherein said defoamer element has a pore size of approximately 400-1800 microns.

40. The device of claim 36 wherein said defoamer element is formed of porous polyurethane foam.

41. The device of claim 33 wherein the flexible bag is positioned within the lower compartment such that blood exiting the outlet of the flexible bag will enter the lower compartment, outside of the flexible bag prior to passing out of the lower compartment through said blood outlet port.

42. The device of claim 33 wherein a minimum operational blood level in the lower compartment is known and wherein:

the flexible bag is positioned within the lower compartment such that the blood outlet of the flexible bag is beneath the minimum blood level in said lower compartment.

43. The device of claim 33 further comprising a plate mounted in the lower compartment to which said flexible bag is mounted.

44. The device of claim 43 wherein said plate is positioned in spaced relation to a first portion of said rigid housing and wherein said flexible bag is positioned between said plate and said first portion of the rigid housing such that expansion of said flexible bag is limited to the space existing between said plate and said portion of said rigid housing.

45. The device of claim 44 wherein the first portion of the rigid housing is the rearward wall of the lower compartment such that the bag is disposed between said plate and said rearward wall.

46. The device of claim 33 wherein the microporous screen element has a pore size of approximately 40-200 microns.

47. The device of claim 33 wherein:

the top end of said flexible bag is open; and

a second porous defoamer element is disposed within the top end of flexible bag such that foam rising within the flexible bag will contact said defoamer element prior to flowing out of the open top end of the flexible bag.

48. The device of claim 47 wherein said second porous defoamer element comprises:

at least a first mass of porous foam material positioned inside the flexible bag, adjacent the open top end thereof.

49. The device of claim 47 wherein said second porous defoamer element further comprises:

at least a second mass of porous foam material disposed outside of said flexible bag near the open top end thereof.

50. The device of claim 33 wherein the portion of said rigid housing defining said lower compartment comprises a forward wall and a rearward wall, opposing said forward wall, said forward wall and said rearward wall being closest to one another at the bottom end of said lower compartment and diverging away from one another thereabove.

51. The device of claim 50 wherein said device is mountable on a stand above a generally horizontal underlying floor such that the forward wall of the lower compartment is disposed at an angle of about 60-85 degrees relative to the underlying floor.

52. The device of claim 51 wherein the forward wall of the lower compartment is disposed at an angle of approximately 70 degrees relative to the underlying floor.

53. The device of claim 33 wherein said rigid housing is formed of clear plastic.

54. The device of claim 53 wherein a gradient scale is formed on the forward wall of the lower compartment to permit measurement of the level of blood within said lower compartment.

55. The device of claim 33 wherein said flexible bag comprises an elongate bag and wherein said blood inlet is formed below the top end of the bag and said blood outlet is formed near the bottom end of the bag.

58. The device of claim 33 wherein a bifurcated connector assembly having a first tubular portion and a second tubular portion is fluidly connected to the blood inlet of the flexible bag and wherein the first tubular portion of the bifurcated connector assembly is fluidly connected to the cardiotomy blood outlet of the upper chamber and wherein the second tubular portion of the bifurcated connector assembly is connected to a venous blood return tube.

59. The device of claim 58 wherein said connector assembly comprises:

a central hub portion having a hollow inner bore and an inner wall formed therewithin to divide said inner bore into a first inner chamber and a second inner chamber;

said first inner chamber being in fluid communication with said first tubular portion and said second tubular portion being in fluid communication with said second inner chamber; and

both the first and second inner chambers of the connector assembly being fluidly connected to the inlet of the flexible bag so that cardiotomy blood and venous return blood may separately enter the flexible bag through the respective first and second inner chambers of the connector assembly.