Pumped-filter blood-processing apparatus and methods

• US 5,954,971 A
• Filed: 01/07/1997
• Issued: 09/21/1999
• Est. Priority Date: 01/07/1997
• Status: Expired due to Term

• Current Assignee: Haemonetics Corporation
• Original Assignee: Haemonetics Corporation
• Inventors: Pages, Etienne, Egozy, Yair, Baratelli, Yves, Dransart, Alain
• Primary Examiner(s): Kim, John
• Application Number:
  US08/779,912
• Time in Patent Office: 987 Days
• Field of Search: 210/645, 210/739, 210/741, 210/767, 210/782, 210/85, 210/87, 210/90, 210/97, 210/103, 210/109, 210/143, 210/252, 210/258, 210/257.1, 604/4, 604/5, 604/6, 604/65, 604/67
• US Class Current: 210/739
• CPC Class Codes: A61M 1/0218 with filters
• CPC Class Codes: A61M 1/0222 and filter bypass
• CPC Class Codes: A61M 1/0231 with gas separating means, e.g. air outlet through microporous membrane or gas bag
• CPC Class Codes: A61M 1/3633 Blood component filters, e.g. leukocyte filters
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3641 Pressure isolators
• CPC Class Codes: A61M 1/3646 Expelling the residual body fluid after use, e.g. back to the body
• 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 2205/331 used as turbidity change detectors, e.g. for priming-blood or plasma-hemoglubine-interface detection

Abstract

Automated filtration of whole blood or blood components is accomplished in a manner that ensures consistent flow or pressure characteristics through the filter. A feedback circuit monitors pressure in the vicinity of the filter inlet and controls operation of a fluid pump that sends one or more unfiltered blood components into the filter. Using this arrangement, a variety of parameters relating to filtration efficacy can be precisely controlled, including flow rate, flow pressure, and average pressure over a predetermined volume. The system may provide an alarm or automatic cut-off in the event a maximum value of one of the parameters is reached or exceeded. The system is also capable of serially filtering multiple blood products through the single filter and accommodating different flow or pressure characteristics associated with each such product.

Claims

1. Apparatus for processing at least two blood components, the apparatus comprising:

a. a source of at least two blood components;

b. collection means comprising first and second separate containers for collecting first and second blood components;

c. a controllable pump for drawing the at least one blood component from the source to the collection means;

d. a filter for filtering at least one blood component prior to collection;

e. means for measuring pressure into the filter;

f. feedback means for controlling the pump based on the measured pressure and the blood component being directed through the filter;

g. means for separately directing the first blood component through the filter and into the first container; and

h. means for separately directing the second blood component through the filter and into the second container.

2. The apparatus of claim 1 further comprising means for withdrawing whole blood from a donor, said means comprising a phlebotomy needle.

3. The apparatus of claim 2 wherein the source of at least two blood components comprises means for separating the withdrawn whole blood into a plurality of components.

4. The apparatus of claim 3 wherein at least one separated component follows a flow path from the separating means through the filter and into the collection means, the feedback means controlling the pump so as to retain a programmed flow rate through the filter.

5. The apparatus of claim 1 further comprising alarm means actuated by the feedback means if the measured pressure exceeds a maximum limit.

6. The apparatus of claim 5 wherein the feedback means stops the pump if the measured pressure exceeds the maximum limit.

7. The apparatus of claim 1 further comprising alarm means actuated by the feedback means if the measured pressure, averaged over a predetermined flow volume, falls outside a predetermined range.

8. The apparatus of claim 3 wherein at least one separated component follows a flow path from the separating means through the filter and into the collection means, the feedback means controlling the pump so as to retain a programmed pressure into the filter.

9. The apparatus of claim 1 wherein the first blood component is plasma and the second blood component is red blood cells.

11. The apparatus of claim 1 wherein the filter is a leukocyte filter.

12. The apparatus of claim 1 wherein the filter is a bacterial filter.

13. The apparatus of claim 1 wherein the filter is a platelet-removal filter.

14. The apparatus of claim 1 wherein the filter is a viral filter.

15. The apparatus of claim 4 wherein the filter is located downstream of the pump.

16. The apparatus of claim 4 wherein the filter is located upstream of the pump.

10. Apparatus for processing at least two blood components, the apparatus comprising:

a. a source of at least two blood components;

b. collection means for collecting the at least one blood component;

c. means for separating the blood components;

d. a controllable pump for directing the blood components to the collection means;

e. a filter for filtering at least one blood component prior to collection, the filter having an internal volume, at least one separated component following a flow path from the separating means through the filter and into the collection means;

f. means for measuring pressure into the filter;

g. feedback means for controlling the pump based on the measured pressure;

h. means for containing a liquid; and

i. means for selectably coupling to the flow path and flowing the liquid therethrough to substantially displace the at least one blood component from the internal volume of the filter.

17. A method of processing at least two blood components, the method comprising the steps of:

a. providing a source of the at least two blood components and a filter;

b. flowing at least one blood component from the source to the filter;

c. filtering each of the at least two blood components separately and, during said filtration, measuring pressure into the filter;

d. controlling the flow based on the measured pressure and the blood component being filtered; and

e. separately collecting each of the at least two blood components.

18. The method of claim 17 further comprising the step of withdrawing whole blood from a donor to provide the at least two blood components.

19. The method of claim 18 wherein the step of providing a source of at least one blood component comprises the step of separating the withdrawn whole blood into a plurality of components.

20. The method of claim 17 wherein the withdrawal is controlled to retain a programmed flow rate through the filter.

21. The method of claim 18 further comprising the step of actuating an alarm if the measured pressure exceeds a maximum limit.

22. The method of claim 21 further comprising the step of terminating withdrawal if the measured pressure exceeds the maximum limit.

23. The method of claim 17 further comprising the step of actuating an alarm if the measured pressure, averaged over a predetermined flow volume, falls outside a predetermined range.

24. The method of claim 17 wherein the withdrawal is controlled to retain a programmed pressure through the filter.

25. The method of claim 17 wherein the first blood component is plasma and the second blood component is red blood cells.

27. The method of claim 17 wherein the filter is a leukocyte filter.

28. The method of claim 17 wherein the filter is a bacterial filter.

29. The method of claim 17 wherein the filter is a platelet-removal filter.

30. The method of claim 17 wherein the filter is a viral filter.

31. The method of claim 17 wherein the at least one blood component is whole blood.

26. A method of processing at least one blood component, the method comprising the steps of:

a. providing a source of the at least one blood component and a filter therefor, the filter having an internal volume;

b. flowing the at least one blood component from the source to the filter;

c. filtering at least one blood component and, during said filtration, measuring pressure into the filter;

d. controlling the flow based on the measured pressure; and

e. pumping a liquid through the filter to substantially displace the at least one blood component from the internal volume of the filter.