Uninterrupted flow pump apparatus and method

• US 6,495,366 B1
• Filed: 09/03/1999
• Issued: 12/17/2002
• Est. Priority Date: 09/03/1999
• Status: Expired due to Term

• Current Assignee: Mallinckrodt Critical Care Finance Inc (Mallinckrodt plc), Mallinckrodt Pharma Ip Trading DAC (Mallinckrodt plc)
• Original Assignee: Therakos, Inc (Mallinckrodt plc)
• Inventors: Briggs, Dennis A.
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): Cole, Monique T.
• Application Number:
  US09/389,463
• Time in Patent Office: 1,201 Days
• Field of Search: 422/101, 422/106, 422/112, 604/5, 604/6-1-, 604/6.08, 604/20, 210/782, 210/646, 210/748, 436/16
• US Class Current: 436/16
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/282 Operational modes
• CPC Class Codes: A61M 1/288 Priming priming in extracorporeal blood circuits A61M1/3643
• CPC Class Codes: A61M 1/3496 Plasmapheresis; Leucopheresis; Lymphopheresis A61M1/3472 takes precedence
• CPC Class Codes: A61M 1/3683 using photoactive agents
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/268 the displacement member being flexible, e.g. membranes, diaphragms or bladders
• CPC Class Codes: A61M 60/37 Haemodialysis, haemofiltration or diafiltration
• CPC Class Codes: A61M 60/43 using vacuum at the blood pump, e.g. to accelerate filling
• CPC Class Codes: A61M 60/508 Electronic control means, e.g. for feedback regulation
• CPC Class Codes: Y10T 436/106664 Blood serum or blood plasma standard or control

Abstract

This invention describes a method for pumping or delivering fluids utilizing a flexible vessel subject to controlled pressures within another pressure vessel. The pressure vessel can be sourced with positive and/or negative (e.g., vacuum) pressure.

Claims

1. A method for providing substantially stable flow of a biological fluid, comrising:

providing a sealed flexible chamber adapted to contain fluid disposed within an outer chamber, wherein said sealed flexible chamber comprises a fluid path between said sealed flexible chamber and the exterior of said outer chamber and wherein said outer chamber is adapted to provide a space containing a pressure sensitive medium around said sealed flexible chamber;

providing means for continuously increasing or decreasing the pressure in a uniform and controlled manner within said space around said sealed flexible chamber; and

changing the pressure with in said space around said sealed flexible chamber such that fluid is displaced into or out of said sealed flexible chamber in a uniform and controlled manner,

wherein said method does not substantially damage said biological fluid.

2. The method of claim 1, wherein said fluid is pressure or flow sensitive.

3. The method of claim 2, wherein said biological fluid comprises whole blood or blood components.

4. The method of claim 3, wherein said blood components comprise white blood cells, red blood cells or plasma.

5. The method of claim 1, wherein said biological fluid comprises a drug.

6. The method of claim 5, wherein said drug is selected from the group consisting of insulin, interferon and erythropoietin.

7. The method of claim 1, further comprising monitoring said increasing or decreasing said pressure within said space around said sealed flexible chamber.

8. The method of claim 1, further comprising monitoring the properties of said fluid displaced into or out of said sealed flexible chamber.

9. The method of claim 7, wherein said monitoring is performed by a computer.

10. The method of claim 8, wherein said monitoring is performed by a computer.

11. The method of claim 1, wherein said pressure sensitive medium comprises air.

12. The method of claim 1, wherein said pressure sensitive medium comprises a fluid.

13. The method of claim 1, wherein the contents of said sealed flexible chamber is sterile.

14. The method of claim 1, wherein said sealed flexible chamber contains buffy coat.

15. The method of claim 1, wherein said sealed flexible chamber comprises more than one fluid path between said sealed flexible chamber and said exterior of said outer chamber.

16. The method of claim 1, wherein said fluid path between said sealed flexible chamber and said exterior of said outer chamber comprises at least one valve capable of controlling fluid flow through said fluid path.

17. The method of claim 16, further comprising controlling said at least one valve capable of controlling fluid flow through said fluid path.

18. The method of claim 17, wherein said controlling is performed by a computer.

19. The method of claim 1, performed in conjunction with a photopheresis process, wherein said photopheresis process comprises:

collecting a buffy-coat fraction of said biological fluid;

adding a photoactivatable drug to said buffy-coat fraction;

exposing said buffy-coat fraction to light energy; and

reinfusing said exposed buffy-coat fraction.

20. The method of claim 19, wherein said buffy-coat fraction comprises white blood cells.

21. The method of claim 19, wherein said photoactivatable drug is 8-methoxypsoralen.

22. The method of claim 19, wherein said light energy comprises ultraviolet A.

23. The method of claim 8, wherein said monitoring further comprises monitoring through use of a load cell.

24. The method of claim 1, wherein said means for continuously increasing or decreasing pressure comprises a pressure reservoir.

25. The method of claim 1, wherein said means for continuously increasing or decreasing pressure comprises a pressure valve.

31. The method of claim 1, wherein said method is used to treat inflammatory bowel disease.

32. The method of claim 31, wherein said inflammatory bowel disease comprises ulcerative colitis.

33. The method of claim 31, wherein said inflammatory bowel disease comprises Crohn'"'"'s disease.

34. The method of claim 1, wherein said method is used to treat graft vs. host disease.

35. The method of claim 1, wherein said method is used to immunomodulate a patient.

26. A method for pumping or delivering biological fluids, comprising:

moving said biological fluids using an apparatus for providing a substantially stable flow of said biological fluids, wherein said apparatus comprises;

an outer chamber adapted to contain a sealed flexible chamber adapted to contain fluid, said sealed flexible chamber comprising a fluid path between said sealed flexible chamber and the exterior of said outer chamber and wherein said outer chamber is adapted to provide a space containing a pressure sensitive medium around said sealed flexible chamber; and

means for increasing or decreasing the pressure in a uniform and controlled manner within said space around said sealed flexible chamber,

wherein said method does not substantially damage said biological fluid.

27. The method of claim 26, performed in conjunction with a photopheresis process, wherein said photopheresis process comprises:

collecting a buffy-coat faction of said biological fluid;

adding a photoactivatable drug to said buffy-coat fraction;

exposing said buffy-coat fraction to light energy; and

reinfusing said exposed buffy-coat fraction.

28. The method of claim 27, wherein said buffy coat fraction comprises white blood cells.

29. The method of claim 27, wherein said photoactivatable drug is 8-methoxypsoralen.

30. The method of claim 27 wherein said light energy comprises ultraviolet A.

36. A method for delivering fluids on conjunction with a pliotopheresis process comprising:

moving said fluids using an apparatus for providing a uniform and controlled flow of said fluids, wherein said apparatus comprises;

an outer chamber adapted to contain a sealed flexible chamber adapted to contain fluid, said sealed flexible chamber comprising a fluid path between said sealed flexible chamber and the exterior of said outer chamber and wherein said outer chamber is adapted to provide a space containing a pressure sensitive medium around said sealed flexible chamber; and

means for increasing or decreasing the pressure in a uniform and controlled manner within said space around said sealed flexible chamber,

wherein said photopheresis process comprises;

collecting a buffy-coat fraction of said biological fluid;

adding a photoactivatable drug to said buffy-coat fraction;

exposing said buffy-coat fraction to light energy; and

reinfusing said exposed buffy-coat fraction.