SYSTEM FOR PROCESSING CELLS AND CONTAINER FOR USE THEREWITH

• US 20110028908A1
• Filed: 03/26/2010
• Published: 02/03/2011
• Est. Priority Date: 11/04/2005
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Trocki, Mark, Uber, Arthur E. III, Cowan, Kevin P., Trombley, Frederick W. III
• Granted Patent: US 8,414,765 B2
• Time in Patent Office: Days
• US Class Current: 604/190
• CPC Class Codes: A61J 1/1443 Containers with means for dispensing liquid medicaments in a filtered or sterile way, e.g. with bacterial filters
• CPC Class Codes: A61J 1/1456 using liquid filters
• CPC Class Codes: A61J 1/1475 Inlet or outlet ports
• CPC Class Codes: A61M 31/005 for contrast media
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/3145 Filters incorporated in syringes
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

A system for processing cells (and/or other injectate components) includes a container and a plunger adapted to be slidably positioned within the container. The system includes at least one inlet port through which a fluid can enter the system and at least one effluent port through which an effluent can exit the system. The plunger section forms a sealing engagement with the inner wall of the container such that rearward motion of the plunger is adapted to draw fluid into the system via the inlet and forward motion of the plunger is adapted to force effluent out of the system via the effluent port.

Claims

1. A container adapted to store and transport an injectate, the container comprising:

a first port at a first axial position within the container;

a first piercing member having a distal end and extending through a septum of the container;

at least a second port at a second axial position within the container, the first axial position and the second axial position being different; and

a second piercing member having a distal end extending through an end closure of the container, the first port being disposed on the distal end of the first piercing member and the second port being disposed on the distal end of the second piercing member;

wherein the container encompasses viable cells within a first fluid and at least one of the first axial position and the second axial position is above an axial position of cells settled on or adjacent to a bottom of the container.

2. The container of claim 1 wherein the cells are retinal pigment epithelial cells supported on microspheres, mesenchymal stem cells, multipotent adult progenitor cells, embryonic stem cells, cardiac precursor cells, cardiac cells, beta-islet precursor cells, beta-islet cells, neural precursor cells, or neural cells.

3. The container of claim 1 comprising a divider disposed within the container and adapted to create a first fluid path on a first side of the divider through which fluid can enter the container and a second fluid path on a second side of the divider through which fluid can exit the container, the second side fluid path including at least one filter through which fluid can pass but through which at least one component of the injectate cannot pass.

4. The container of claim 3 wherein the container encompasses viable cells within the first fluid and the filter prevents cells from passing therethrough.

19. The container of claim 1 wherein the container is adapted to be subjected to freezing and thawing.

20. The container of claim 1 wherein the first port and the second port are formed monolithically with the container.

5. A system for processing cells, comprising:

a container;

a plunger adapted to be slidably positioned within the container;

at least one inlet port through which a fluid can enter the container; and

at least one effluent port through which an effluent can exit the container, the plunger section forming a sealing engagement with the inner wall of the container such that rearward motion of the plunger is adapted to draw fluid into the system via the inlet port and forward motion of the plunger is adapted to force effluent out of the system via the effluent port.

6. The system of claim 5 wherein the effluent port is adapted to effect delivery of cells therethrough to a patient.

7. The system of claim 5 further comprising an outlet port adapted to effect delivery of cells therethrough to a patient.

8. The system of claim 5 comprising a filter in fluid connection with the effluent port to prevent cells from exiting via the effluent port.

9. The system of claim 5 further comprising a first check valve in fluid connection with the inlet port and a second check valve in fluid connection with the effluent port.

10. The system of claim 5 wherein the plunger comprises a filter disposed therein that allows fluid to pass therethrough but prevents cells from passing therethrough.

11. The system of claim 10 wherein the filter separates the cells from the effluent port.

12. The system of claim 11 wherein the filter also separates the cells from the inlet port.

13. The system of claim 12 further comprising an outlet port in fluid connection with the cells adapted to effect delivery of cells therethrough to a patient.

14. The system of claim 13 wherein the outlet port is adapted to be closed during processing of the cells during which fluid enters the system via the inlet port and effluent exits the system via the effluent port.

15. The system of claim 14 wherein the effluent port is adapted to be closed when the outlet port is opened to deliver cells therethrough.

16. The system of claim 13 wherein the inlet port is in fluid connection with a passage through the plunger so that the fluid can enter the plunger and pass through the filter.

17. The system of claim 13 wherein the effluent port is in fluid connection with a passage through the plunger so that the effluent can pass through the filter and exit the effluent port.

18. The system of claim 5 wherein the plunger includes a sealing member adapted to form a sealing engagement with an interior wall of the container.