Disposable Fluid Circuits And Methods For Cell Washing With On-Line Dilution Of Cell Feed

• US 20130092630A1
• Filed: 12/07/2012
• Published: 04/18/2013
• Est. Priority Date: 03/11/2011
• Status: Active Grant

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Wegener, Christopher
• Granted Patent: US 9,744,498 B2
• Time in Patent Office: Days
• US Class Current: 210/645
• CPC Class Codes: A61M 1/0209 Multiple bag systems for separating or storing blood components
• CPC Class Codes: A61M 1/0218 with filters
• CPC Class Codes: A61M 1/0236 with sampling means, e.g. sample bag or sampling port
• CPC Class Codes: A61M 1/265 inducing Taylor vortices
• 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: B01D 2315/02 Rotation or turning
• CPC Class Codes: B01D 61/00 Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor separation of gases or vapours by diffusion B01D53/22
• CPC Class Codes: B01D 63/16 Rotary, reciprocated or vibrated modules

Abstract

Systems and methods for the washing and processsing of biological fluid/biological cells are disclosed. The systems and methods prevent inadvertent target cell loss by monitoring pressure and providing for the dilution of the cell feed.

Claims

1. A system for the treatment of biological fluid including biological cells comprising:

(a) a reusable cell processing apparatus comprising a separator element for receiving a separation device and effecting the separation of said biological fluid into two or more components and a programmable microprocessor programmed to process biological fluid through a fluid circuit, said microprocessor being programmed to instruct said system to deliver a pre-selected volume of diluent to a source of biological fluid; and

(b) a disposable fluid circuit comprising at least one membrane separation device in fluid communication with a first product container and an access device for sterile connection to a source of biological fluid.

2. The system of claim 1 wherein said reusable cell processing apparatus comprises a programmable microprocessor programmed to process biological fluid through said fluid processing circuit.

3. The system of claim 2 wherein said reusable cell processing apparatus comprises clamps and pumps adapted for association with selected flow paths of said fluid processing circuit to control flow through said circuit.

4. The system of claim 3 wherein said separation device utilizes a spinning membrane.

5. The system of claim 1 further comprising a pressure sensor for monitoring pressure within said system.

6. The system of claim 5 wherein said microprocessor is programmed to combine a volume of diluent with said source of said biological fluid.

7. The system of claim 6 wherein said microprocessor is programmed to adjust said volume of diluent in response to a pressure reading provided by said pressure sensor.

8. The system of claim 7 wherein said microprocessor is programmed to reduce the volume of diluent when said pressure reading is below a selected threshold.

9. The system of claim 6 wherein said microprocessor is programmed to combine said diluent with said biological fluid prior to detection of the concentration polarization limit.

10. A method for washing biological cells comprising:

obtaining a separator comprising a relatively rotatable cylindrical housing and an internal member, wherein said cylindrical housing has an interior surface and said internal member has an exterior surface, said surfaces defining a gap therebetween, wherein at least one of said surfaces includes a porous membrane;

drawing biological cells from a container in flow communication with said separator;

diluting said biological cells;

introducing said diluted cells into said gap of said separator;

rotating at least one or both of said housing and said internal member;

separating said cells from said liquid medium;

concentrating said cells;

removing at least some of said concentrated cells from said separator through a first outlet;

removing at least some of said separated liquid medium from said separator through a second outlet;

monitoring the pressure; and

optionally adjusting the dilution of said cells based on said pressure monitoring.

11. The method of claim 10 comprising diluting said cells by first introducing said diluent into said separator followed by adding said biological cells to said separator.

12. The method of claim 10 comprising diluting said cells by combining said biological cells with said diluent and introducing said combination of cells and diluent into said separator.

13. The method of claim 10 comprising diluting said cells only in response to a detected increase in pressure.

14. The method of claim 10 comprising diluting said cells prior to a detected increase in pressure.

15. The method of claim 10 comprising using PI, PD or PID controls to maintain the pressure during processing below a selected pressure point.

16. The method of claim 10 comprising monitoring the pressure for a concentration polarization limit.