Low extracorporeal volume treatment system

• US 6,793,643 B1
• Filed: 04/21/2000
• Issued: 09/21/2004
• Est. Priority Date: 04/21/2000
• 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): Sykes, Angela D.
• Assistant Examiner(s): DEAK, LESLIE R
• Application Number:
  US09/556,832
• Time in Patent Office: 1,614 Days
• Field of Search: 604/5.01, 604/6.01, 604/19, 604/28, 604/65-67, 604/6.09, 604/6.1, 604/6.11, 604/6.08, 210/647, 210/739, 210/782, 210/101, 210/515
• US Class Current: 604/6.08
• CPC Class Codes: A61M 1/3606 Arrangements for blood-volume reduction of extra-corporeal circuits
• CPC Class Codes: A61M 1/3681 by irradiation
• CPC Class Codes: A61M 1/3683 using photoactive agents
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61M 1/3696 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
• CPC Class Codes: A61M 2205/3393 by weighing the reservoir

Abstract

A means, apparatus, and system for reducing the net fluid volume deficiency in a patient during a medical treatment process. The invention seeks to modify a batch-type process to achieve the efficiency of a continuous process by precisely measuring the net change in fluid volume within a patient and dispensing the appropriate amount of biological fluids to a patient via IV lines or by recycling blood components into the patient while biological fluids are being withdrawn. The apparatus includes subcomponent lines, valving means, pumping means, load cells, storage chambers, a centrifuge, and centrifuge bowls. The system may have numerous feedback components to accurately measure and control the flow rates and amount of fluid dispensed to a patient.

Claims

1. A method for reducing a net fluid volume change of a biological fluid in a patient during a photophoresis process, comprising the steps of:

removing said biological fluid from said patient;

determining said net fluid volume change in said patient;

adjusting said net fluid volume change of said patient so that a minimum net fluid volume deficiency is obtained, wherein said adjusting step comprises adding fluid to said patient both at a point in time during which said biological fluid is being removed from said patient and at a point in time during which said biological fluid is not being removed from said patient; and

maintaining said minimum net fluid volume deficiency in said patient after said adjusting step.

2. The method of claim 1, wherein said determining said net fluid volume change comprises measuring the change in weight of a chamber associated with a load cell.

3. The method of claim 1, wherein said adjusting said net fluid volume change comprises decreasing said fluid added to said patient.

4. The method of claim 3, wherein said fluid comprises a primer fluid.

5. The method of claim 4, wherein said primer fluid further comprises red blood cells and plasma.

6. The method of claim 4, wherein said primer fluid further comprises red blood cells.

7. The method of claim 4, wherein said primer fluid further comprises plasma.

8. The method of claim 1, wherein said adjusting said net fluid volume change comprises increasing said fluid added to said patient.

9. The method of claim 8, wherein said fluid comprises a primer fluid.

10. The method of claim 9, wherein said primer fluid further comprises red blood cells and plasma.

11. The method of claim 9, wherein said primer fluid further comprises red blood cells.

12. The method of claim 9, wherein said primer fluid further comprises plasma.

13. The method of claim 1, wherein said adjusting of said net fluid volume change comprises controlling a valving means to change a flow rate of a fluid.

14. The method of claim 1, wherein said adjusting of said net fluid volume change comprises controlling a pumping means used to change a flow rate of a fluid.

15. The method of claim 14, wherein said adjusting of said net fluid volume change comprises controlling said pumping means so that said flow rate is increased.

16. The method of claim 14, wherein said adjusting of said net fluid volume change comprises controlling said pumping means so that said flow rate is decreased.

17. The method of claim 14, wherein said fluid comprises a primer fluid.

18. The method of claim 17, wherein said primer fluid further comprises red blood cells and plasma.

19. The method of claim 17, wherein said primer fluid further comprises red blood cells.

20. The method of claim 17, wherein said primer fluid further comprises plasma.

21. The method of claim 13, wherein said adjusting of said net fluid volume change comprises controlling said valving means so that said flow rate is increased.

22. The method of claim 13, wherein said adjusting of said net fluid volume change comprises controlling said valving means so that said flow rate is decreased.

23. The method of claim 13, wherein said fluid comprises a primer fluid.

24. The method of claim 23, wherein said primer fluid further comprises red blood cells and plasma.

25. The method of claim 23, wherein said primer fluid further comprises red blood cells.

26. The method of claim 23, wherein said primer fluid further comprises plasma.

27. The method of claim 1, wherein said maintaining step comprises monitoring said net fluid volume change to regulate said minimum net fluid volume deficiency.

29. The method of claim 23, wherein said means for determining said net fluid volume change in said patient comprises a load cell.

28. A system for regulating a photophoresis process for reducing a net fluid volume change in a patient, comprising:

means for removing biological fluid from said patient;

means for determining said net fluid volume change in said patient;

means for adjusting said net fluid volume change of said patient so that a minimum net fluid volume deficiency is obtained, wherein said means for adjusting is adapted to add fluid to said patient both at a point in time during which said biological fluid is being removed from said patient and at a point in time during which said biological fluid is not being removed from to said patient; and

means for maintaining said minimum net fluid volume deficiency in said patient after said adjusting.

30. The system of claim 28, wherein said means for adjusting said net fluid volume change comprises a valving means.

31. The system of claim 28, wherein said means for adjusting said net fluid volume change comprises a pumping means for increasing or decreasing the flow of a fluid.

32. The system of claim 31, wherein said fluid comprises a primer fluid.

33. The system of claim 32, wherein said primer fluid further comprises red blood cells and plasma.

34. The system of claim 32, wherein said primer fluid further comprises red blood cells.

35. The system of claim 32, wherein said primer fluid further comprises plasma.

36. The system of claim 28, wherein said means for adjusting said net fluid volume change comprises a valving means for increasing or decreasing the flow of a fluid.

37. The system of claim 36, wherein said fluid comprises a primer fluid.

38. The system of claim 37, wherein said primer fluid further comprises red blood cells and plasma.

39. The system of claim 37, wherein said primer fluid further comprises red blood cells.

40. The system of claim 37, wherein said primer fluid further comprises plasma.

41. The system of claim 28 wherein:

said means for determining said net fluid volume change in said patient comprises a load cell;

said means for adjusting said net fluid volume change of said patient comprises a load cell, pumping means and a valving means; and

said means for maintaining said minimum net fluid volume deficiency in said patient comprises a load cell, pumping means, and a valving means.

42. The system of claim 41, wherein said means for adjusting said net fluid volume change further comprises a controller in communication with said load cell, said valving means, and said pumping means, and controller comprising a computer that regulates and controls said load cell, said valving means, and said pumping means.

43. The system of claim 41, wherein said means for maintaining said minimum net fluid volume deficiency further comprises a controller in communication with said load cell, said valving means, and said pumping means, said controller comprising a computer that regulates and controls said load cell, said valving means, and said pumping means.

44. A system for regulating a photophoresis process for reducing a net fluid volume change in a patient, comprising:

a first line configured to transport a biological fluid from a patient;

at least one centrifuge connected to said first line for separating said biological fluid into a first part and a second part;

storage chamber configure to receive said first part;

a second line configured to transport said first part, said second line in fluid communication with said centrifuge and said storage chamber;

a load cell configured to weigh the contents of said storage chamber;

a third line configured to transport said first part from said storage chamber to said patient;

a pump disposed within said third line;

a valve disposed within said third line; and

a controller in communication with said load cell, said pump, and said valve, said controller comprising a computer configured to regulate and controls said load cell, said pump, and said valve.

45. The system of claim 44 further comprising a plurality of centrifuges.

46. The system of claim 45 further comprising at least one valve in said first line configured to allow said first line to be in fluid communication with any one of said plurality of centrifuges.

47. The system of claim 44 wherein said first part comprises plasma.

48. The system of claim 44 wherein said first part comprises red blood cells.

49. A system for regulating a photophoresis process for reducing a net fluid volume change in a patient, comprising:

a first line configured to transport a biological fluid from a patient;

at least one centrifuge connected to said first line for separating said biological fluid into a first part and a second part;

a storage chamber configured to receive said first part;

a second line configured to transport said first part, said second line in fluid communication with said centrifuge and said storage chamber;

a load cell configured to weigh the contents of said storage chamber;

a third line configured to transport said first part form said storage chamber to said patient;

a pump disposed within said third line;

a valve disposed within said third line;

a controller in communication with said load cell, said pump, and said valve, said controller comprising a computer configured to regulate and controls said load cell, said pump, and said valve; and

a dual cannula needle having a first cannula and a second cannula, wherein said first line is connected to said first cannula and said second line is connected to said second cannula.