System and method for collecting plasma protein fractions from separated blood components

• US 8,202,240 B2
• Filed: 04/24/2009
• Issued: 06/19/2012
• Est. Priority Date: 08/12/2008
• Status: Active Grant

• Current Assignee: Terumo BCT, Inc. (Terumo Corporation)
• Original Assignee: Caridianbct Biotechnologies LLC (Baxter International Inc.)
• Inventors: Felt, Thomas J., Corbin, Frank III, Urdahl, Steven Gage
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US12/429,325
• Publication Number:
  US 20100042038A1
• Time in Patent Office: 1,152 Days
• Field of Search: 604/4.01, 604/5.01, 604/6.01, 604/6.02, 604/6.04, 604/6.09, 604/6.11, 210/645, 210/781, 210/782, 210/500.23
• US Class Current: 604/6.04
• CPC Class Codes: A61M 1/3496 Plasmapheresis; Leucopheresis; Lymphopheresis A61M1/3472 takes precedence
• CPC Class Codes: A61M 1/36222 Details related to the interface between cassette and machine
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/362262 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/362263 Details of incorporated filters
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 2205/128 with incorporated valves

Abstract

Method and apparatus for separating plasma from blood in a membrane separator and further separator the separated plasma into desired plasma proteins in a plasma separator fluidly connected to the membrane separator to receive the separated plasma.

Claims

1. An integrated pre-connected disposable set for separating whole blood into plasma protein fractions comprising:

a first hollow fiber membrane separator having an inlet and a first outlet for separating whole blood into plasma and other blood components;

a plasma collect tubing pre-connected to the first outlet of the first membrane separator;

a plasma protein collection container; and

a second hollow fiber membrane separator comprising

an inlet pre-connected to the plasma collect tubing; and

a first outlet connected to the plasma protein collection container to connect the second hollow fiber membrane separator between the first outlet of the first hollow fiber membrane separator and the plasma protein collection container wherein separated plasma exiting the first hollow fiber membrane separator from the first membrane first outlet passes through the collect tubing to the second hollow fiber membrane separator for separation into desired plasma proteins and wherein such plasma proteins are collected in the plasma protein collection container;

wherein the set further comprises a cassette having internal passageways for fluidly connecting the first membrane separator to the second membrane separator.

2. The disposable set of claim 1 further comprising

a second outlet on the first membrane separator, and

return tubing for returning the other blood components to a donor through the second outlet.

3. The disposable set of claim 2 further comprising a blood removal and return assembly for removing blood from a donor and providing it to the first membrane separator and fluidly connected to the return tubing for returning the other components back to the donor.

4. The disposable set of claim 3 further comprising

a second outlet on the second membrane separator, and

a plasma return assembly fluidly connected to the second outlet to return any uncollected plasma or plasma proteins back to a donor through the second membrane second outlet and the blood removal and return assembly.

5. The disposable set of claim 1 wherein the first hollow fiber membrane separator comprises a pore size for permitting plasma to pass through the membrane but not other blood components.

6. The disposable set of claim 5 wherein the second membrane separator comprises a membrane having a pore size for permitting plasma to pass through the membrane but not desired plasma proteins to be collected.

7. The disposable set of claim 6 wherein the pore size of the second membrane separator is such that low molecular weight plasma proteins pass through the membrane and high weight plasma proteins are collected.

8. The disposable set of claim 1 wherein the second membrane separator comprises a membrane having a pore size for permitting plasma to pass through the membrane but not desired plasma proteins to be collected.

9. The disposable set of claim 8 wherein the pore size of the second membrane separator is such that low molecular weight plasma proteins pass through the membrane and high weight plasma proteins are collected.

10. The disposable set of claim 1 further comprising

a second outlet on the second membrane separator, and

a plasma return assembly fluidly connected to the second outlet to return any uncollected plasma or plasma proteins back to a donor through the second membrane second outlet.

11. Apparatus for separating whole blood into plasma proteins comprising

a pump system for cooperating with an integrated pre-connected disposable set comprising

a removal pump for removing blood from a donor;

a return pump for returning uncollected whole blood components to the donor;

a collect pump for pumping separated plasma to a second hollow fiber membrane separator;

a integrated pre-connected set comprising

a first hollow fiber membrane separator for receiving blood removed by the removal pump and separating such blood into plasma and uncollected blood components;

a second hollow fiber membrane separator for receiving separated plasma pumped by the collect pump from the first membrane separator and for separating such plasma into at least one plasma protein fraction;

a collection container connected to the second hollow fiber membrane separator for receiving the at least one plasma protein fraction wherein the second hollow fiber membrane separator is between the first hollow fiber membrane separator and the collection container;

wherein the integrated pre-connected set comprises a cassette having a removal fluid flow passageway through which whole blood flows to the first membrane separator.

12. The apparatus of claim 11 further comprising a plasma return pump for returning any plasma or plasma proteins not collected from the second membrane separator to the donor.

13. The apparatus of claim 11 wherein the cassette further comprises a return fluid flow passageway through which uncollected blood components and return plasma flow to be returned to the donor.

14. The apparatus of claim 13 wherein the return fluid flow passageway comprises a reservoir for receiving uncollected plasma and blood components for return to the donor.

15. The apparatus of claim 11 wherein the cassette comprises a collect fluid flow passageway through which separated plasma flows from the first membrane separator to the second membrane separator.

16. The apparatus of claim 11 wherein the first membrane separator comprises a hollow fiber membrane with pore size for permitting plasma to pass through the membrane but not the uncollected whole blood components.

17. The apparatus of claim 16 wherein the second membrane separator comprises a membrane having a pore size for permitting plasma to pass through the membrane but not the at least one plasma protein fraction.

18. The apparatus of claim 17 wherein the pore size of the membrane of the second membrane separator is such that low molecular weight plasma proteins pass through the membrane and high weight plasma proteins form the plasma protein fraction to be collected.

19. The apparatus of claim 11 wherein the second membrane separator comprises a hollow fiber membrane having a pore size for permitting plasma to pass through the membrane but not the at least one plasma protein fraction.

20. The apparatus of claim 19 wherein the pore size of the membrane of the second membrane separator is such that low molecular weight plasma proteins pass through the membrane and high weight plasma proteins form the plasma protein fraction to be collected.

21. The method of collecting a concentrated plasma product from whole blood comprising:

removing whole blood from a donor;

separating the whole blood using a first hollow fiber membrane separator into a plasma component and other components;

returning the other components to the donor;

separating the separated plasma using a second hollow fiber membrane separator into at least one protein fraction;

collecting the separated at least one protein fraction; and

concentrating the collected at least one protein fraction using a plasma fractionator to further concentrate the desired proteins in the at least one fraction wherein the step of concentrating the collected at least one protein fraction comprises precipitating out the desired proteins using cold alcohol fractionation.

22. The method of collecting a concentrated plasma product from whole blood comprising:

removing whole blood from a donor;

separating the whole blood using a first hollow fiber membrane separator into a plasma component and other components;

returning the other components to the donor;

separating the separated plasma using a second hollow fiber membrane separator into at least one protein fraction;

collecting the separated at least one protein fraction; and

concentrating the collected at least one protein fraction using a plasma fractionator to further concentrate the desired proteins in the at least one fraction wherein the step of concentrating the collected at least one protein fraction comprises precipitating out the desired proteins using cold alcohol fractionation and passing the collected fraction through a stationary phase to concentrate the desired plasma proteins.