Blood component preparation (BCP) device and method of use thereof

• US 6,605,223 B2
• Filed: 10/22/2001
• Issued: 08/12/2003
• Est. Priority Date: 06/20/2000
• Status: Expired due to Fees

• Current Assignee: Medicept Incorporated
• Original Assignee: Medicept Incorporated
• Inventors: Jorgensen, Glen, Barry, Donald E.
• Primary Examiner(s): Reifsnyder, David A.
• Application Number:
  US10/008,605
• Publication Number:
  US 20020082153A1
• Time in Patent Office: 659 Days
• Field of Search: 210/745, 210/782, 210/806, 210/94, 210/143, 210/295, 210/232, 210/304, 210/360.1, 210/324, 210/380.1, 494/21, 494/25, 494/2, 494/26, 494/36, 494/37, 494/45, 494/84, 604/406, 604/408, 604/410
• US Class Current: 210/745
• 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 1/362262 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/362264 the filter being a blood filter
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/3633 Blood component filters, e.g. leukocyte filters
• 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 1/3698 Expressing processed fluid out from the turning rotor using another fluid compressing the treatment chamber; Variable volume rotors
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: B01D 17/0217 by centrifugal force
• CPC Class Codes: B01D 17/10 with stationary filtering elements
• CPC Class Codes: B01D 21/262 by using a centrifuge
• CPC Class Codes: B01D 2221/10 Separation devices for use in medical, pharmaceutical or laboratory applications, e.g. separating amalgam from dental treatment residues
• CPC Class Codes: B04B 13/00 Control arrangements specially designed for centrifuges; Programme control of centrifuges control arrangements for feed, charge, or discharge B04B11/00
• CPC Class Codes: B04B 2005/0478 with filters in the separation chamber
• CPC Class Codes: B04B 2009/143 by weight compensation with liquids
• CPC Class Codes: B04B 5/0421 pivotably mounted
• CPC Class Codes: B04B 5/0428 with flexible receptacles
• CPC Class Codes: B04B 9/14 Balancing rotary bowls balancing per se G01M; Schrappers

Abstract

An automated blood separation method and apparatus is described that allows for the separation of multiple units of blood simultaneously. The method and apparatus reliably and quickly separates blood into its components. An auto-balancing feature within the apparatus automatically preferably compensates for the changing state of imbalance, thereby eliminating the need for additional balancing steps during the separation process. The apparatus has a rotor into which a plurality of cassettes can be inserted. The cassettes have a number of sections for the containment of the whole blood and for the separated blood components, which are contained in disposable bags. The rotor is placed into a centrifuge assembly, and the blood components are then separated and transferred to the bags in the individual sections of the cassettes. Means for including secondary separation devices such as filters is included. The manufacturing information regarding the lot identities used and the conditions under which each unit was processed is also included.

Claims

1. An automated device for separating blood into its components comprising:

one or more cassettes;

a plurality of cavities in each cassette for housing a whole blood bag and at least one blood component bag;

the whole blood bag and blood component bags in fluid communication with eachother;

wherein the one or more cassettes are stacked in a co-axial configuration in the centrifuge;

wherein the one or more cassettes are placed into a centrifuge and, as the centrifuge spins the one or more cassettes, whole blood in the whole blood bag separates into its components, and the components are caused to flow into different blood component bags.

2. The device of claim 1, a plurality of cassettes are supplied with whole blood and multiple units of blood are separated into their components simultaneously.

3. The device of claim 2, wherein the cassettes are circular.

4. The device of claim 1, wherein each cassette further comprises an expressor bag or expressor chamber sealed by a flexible membrane, whereby the expressor bag or the flexible membrane is in contact with the whole blood bag and/or at least one blood component bag, whereby as expressor fluid or gas is fed into the expressor chamber or expressor bag, the flexible membrane or expressor bag expands against the whole blood bag and/or at least one blood component bag, thereby compressing the whole blood bag and/or at least one blood component bag to force separated blood components to flow into different blood component bags.

5. The device of claim 4, wherein each cassette comprises at least a top portion and a bottom portion, the expresser bag or the expresser chamber and flexible membrane, plurality of cavities and the whole blood bag and blood component bags situated in the portions such that the whole blood bag and blood component bags are in fluid communication with each other and the expressor bag or the expressor chamber and flexible membrane are positioned in contact with the whole blood bag and/or at least one blood component bag.

6. The device of claim 5, wherein the top portion houses the expressor bag or the expressor chamber and flexible membrane and the bottom portion housing the plurality of cavities and the whole blood bag and blood component bags.

7. The device of claim 6, wherein the bottom portion further houses one or more filters.

8. The device of claim 5, further comprising at least one middle portion.

9. The device of claim 8, wherein the middle portion houses the expressor bag or expressor chamber and flexible membrane, the top portion houses the whole blood bag and the bottom portion houses the blood component bags.

10. The device of claim 9, wherein the middle portion further houses one or more filters.

11. The device of claim 8, wherein the top, bottom and middle portions are removably connected to provide access to the interior of the cassette.

12. The device of claim 8, wherein the top, bottom and middle portions are connected with a hinge.

13. The device of claim 1, wherein the whole blood bag and blood component bags are interconnected with tubing.

14. The device of claim 1, wherein the cassettes are self-balancing as the blood components move from one cavity to another.

15. The device of claim 1, further comprising at least one secondary separation means, such as a filter or packed column, in line with the fluid communication between the whole blood bag and/or blood component bags, thereby providing filtering of the whole blood and/or blood components as the whole blood and/or blood components flow from one bag to another.

16. The device of claim 1 or 15, wherein a micro-digital RF tag is affixed to the whole blood bag and the blood component bags, wherein the micro-digital RF tag contains manufacturing data such as lot codes of the bag set and the secondary separation means, and wherein information can be added to the tag such as the donor ID number, red blood cell bag ID number, platelet concentrate bag ID number, plasma bag ID number, operator number, purity of platelet concentrate, the time of collection of the whole blood, temperature profile and speed profile.

17. The device of claim 16, wherein data is read from the RF ID tag and data can be added to the RF ID tag, wherein the data is used to set processing control parameters such as temperature, time, g-force and valve timing and wherein the actual output of the processing control parameters are recorded.

18. The device of claim 16, wherein the data is automatically added to the tag as the cassette is placed in the centrifuge.

19. The device of claim 15, wherein the at least one secondary separation means is positioned in between the whole blood bag and a platelet concentrate bag and wherein platelet rich plasma supernatant is expressed through the secondary separation device as the platelet rich plasma supernatant flows from the whole blood bag to the platelet concentrate bag.

20. The device of claim 19, wherein the at least one secondary separation means is a leukodepleting filter.

21. The device of claim 15, wherein the at least one secondary separation means is a separation means that is operated statically at zero rpm to prevent the centrifugal force from interfering with the separation capacity of the separation means.

22. The device of claim 21, further including a holding bag between the whole blood bag and a platelet concentrate bag, wherein after the centrifuge spins the one or more cassettes, and the whole blood in the whole blood bag separates into its components, platelet rich plasma from the whole blood bag is expressed into the holding bag and after the centrifugal speed is zero, the platelet rich plasma in the holding bag is expressed through the at least one secondary separation means and into the platelet concentrate bag.

23. The device of claim 1, further comprising a first optical sensor situated to monitor the fluid flow between the whole blood bag and a platelet concentrate bag and a plasma bag.

24. The device of claim 23, further comprising a first valve positioned in the fluid flow between the whole blood bag and the platelet concentrate bag and plasma bag, wherein when the first optical sensor detects the presence of red blood cells in the fluid flow between the whole blood bag and a platelet concentrate bag and a plasma bag, the first valve closes off the fluid flow between the whole blood bag and the platelet concentrate bag and plasma bag.

25. The device of claim 24, further comprising a second valve positioned between the fluid flow between the whole blood bag and a red blood cell bag, wherein when the first valve closes off the fluid flow between the whole blood bag and the platelet concentrate bag and plasma bag, the second valve opens up the fluid flow between the whole blood bag and red blood cell bag.

26. The device of claim 25, further comprising a third valve positioned in the fluid flow between the platelet concentrate bag and plasma bag and a fourth valve positioned between the platelet concentrate bag and the whole blood bag, wherein the valves prevent the remixing of components within the different blood component bags during the rapid deceleration of the centrifuge.

27. The device of claim 23, wherein the valve is a single 3-way valve that is further positioned between the fluid flow between the whole blood bag and a red blood cell bag and wherein after the 3-way valve closes off the fluid flow between the whole blood bag and the platelet concentrate bag and plasma bag, the single 3-way valve then opens up the fluid flow between the whole blood bag and red blood cell bag.

28. The device of claim 23, wherein the optical sensor monitors the conditions of the fluid flow for measuring whether the materials flowing from one bag to another bag are within acceptable limits.

29. The device of claim 1, further including an optical sensing means for optically identifying manufacturing information, such as lot code and part number from the bags that are housed within the cassette as the cassette is placed in the centrifuge.

30. The device of claim 29, wherein the optical sensing means is a bar code reader.

31. A method for separating blood into its components comprising utilizing the device of any one of claims 1-21 and 29-22.

32. A method for the separation of whole blood into its components, the method comprising the steps of:

collecting a unit of whole blood in at least one whole blood bag;

providing a centrifuge device and a plurality of cassettes structured and constructed to be placed in the centrifuge, each cassette having a plurality of sections including an expressor chamber or expressor bag section, wherein the plurality of cassettes are stacked in a co-axial configuration in the centrifuge;

placing at least one whole blood bag into a section in a cassette;

placing at least one cassette holding the whole blood bag into the centrifuge;

causing the centrifuge to spin;

allowing the whole blood to separate into its components;

introducing expressor fluid or gas to the expressor chamber or expressor bag; and

allowing the expressor fluid or gas to force the blood components to flow into separate collection bags.

33. A method for the separation of whole blood into its components, the method comprising the steps of:

(a) providing an automated device for separating blood into its components comprising;

one or more cassettes;

a plurality of cavities in each cassette for housing at least a whole blood bag and at least one blood component bag;

the whole blood bag and blood component bags in fluid communication with each other;

(b) placing a whole blood bag holding whole blood and at least one blood component bag in the plurality of cavities in each cassette;

(c) placing the one or more cassettes into a centrifuge;

(d) spinning the centrifuge;

(e) allowing the red blood cells to separate from the plasma in the whole blood bag;

(f) allowing the plasma to flow from the whole blood bag to a first blood component bag;

(g) allowing the platelets to sediment radially and collect on the surfaces of the first blood component bag; and

(h) allowing the plasma minus the platelets collected on the surfaces of the first blood component bag to flow through the first blood component bag into a second blood component bag.

34. The method of claim 33, further comprising the steps of:

allowing the red blood cells in the whole blood bag to flow from the whole blood bag to a third blood component bag.

35. The method of claim 33, wherein each cassette further comprises an expressor bag or expressor chamber sealed by a flexible membrane in contact with the whole blood bag and/or at least one blood component bag, and wherein the method further comprises the steps of:

after allowing the red blood cells to separate from the plasma in the whole blood bag;

feeding expressor fluid or gas into the expressor chamber or expressor bag such that the flexible membrane or expressor bag expands against the whole blood bag and/or at least one blood component bag;

allowing the expressor bag or flexible membrane to compress the whole blood bag and/or at least one blood component bag to force separated blood components to flow into different blood component bags.

36. The method of claim 33, wherein the device further includes at least one filter in line with the fluid communication between the whole blood bag and/or blood component bags, thereby providing filtering of the whole blood and/or blood components as the whole blood and/or blood components flow from one bag to another.

37. The method of claim 33, wherein the device further comprises a first optical sensor situated to monitor the fluid flow between the whole blood bag and first blood component bag, and a first valve positioned in between the fluid flow between the whole blood bag and first blood component bag, and wherein the method further comprises the steps of:

monitoring the fluid flow of the plasma from the whole blood bag to the first blood component bag, for red blood cells; and

closing off the first valve when red blood cells are monitored.

38. The method of claim 37, wherein the device further comprises a second valve positioned between the whole blood bag and the third blood component bag and wherein the method further comprises the steps of:

opening the second valve after closing off the first valve, thereby allowing the red blood cells to flow into the third blood component bag.

39. The method of claim 37, further comprising:

using the first optical sensor to measure whether the materials flowing from the whole blood bag to the first blood component bag are within acceptable limits.

40. The method of claim 39, further comprising a third valve positioned in the fluid flow between the platelet concentrate bag and plasma bag and a fourth valve positioned between the platelet concentrate bag and the whole blood bag, wherein the valves prevent the remixing of components within the different blood component bags during the rapid deceleration of the centrifuge.