System for processing cells and container for use therewith

• US 9,629,780 B2
• Filed: 03/18/2013
• Issued: 04/25/2017
• Est. Priority Date: 11/04/2005
• Status: Expired due to Fees

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Uber, III, Arthur E, Trombley, III, Frederick W, Trocki, Mark, Cowan, Kevin P
• Primary Examiner(s): CECIL, TERRY K
• Application Number:
  US13/845,713
• Publication Number:
  US 20140163475A1
• Time in Patent Office: 1,499 Days
• Field of Search: None
• 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 container adapted to store and transport an injectate is disclosed. The container includes a divider which extends from an open top end toward a closed bottom end, the divider spaced apart from the closed bottom end to define an opening and separating the container into a first fluid path on a first side of the divider through which fluid can enter the container through the inlet port and a second fluid path on a second side of the divider through which fluid can enter the opening and exit the container through the outlet port. The second fluid path includes at least one filter between the opening and the open top end through which fluid can pass from the first fluid path to the second fluid path but through which at least one component of the injectate cannot pass.

Claims

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

an open top end, a closed bottom end, and a central axis extending between the open top end and the closed bottom end;

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

a first piercing member having a distal end and extending through an end closure of the container enclosing the open top end, the first piercing member extending toward the closed bottom end of the container;

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

a second piercing member having a distal end extending through the end closure of the container toward the closed bottom end of the container; and

a divider disposed within the container, the divider extending from the open top end toward the closed bottom end and spaced apart from the closed bottom end and defining an opening, the divider separating the container into a first fluid path on a first side of the divider through which fluid can enter the container through the inlet port and a second fluid path on a second side of the divider through which fluid can enter the opening and exit the container through the outlet port, the second fluid path including at least one filter between the opening and the open top end through which fluid can pass from the first fluid path to the second fluid path but through which at least one component of the injectate cannot pass,

wherein the inlet port is disposed on the distal end of the first piercing member and the outlet port is disposed on the distal end of the second piercing member; and

wherein, in use, 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 the closed bottom end 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, wherein the container encompasses the viable cells within the first fluid and the at least one filter prevents the viable cells from passing therethrough.

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

5. The container of claim 1, wherein an interior surface of the closed bottom end of the container is rounded.

6. The container of claim 1, wherein the inlet port is configured for filling the container with buffer solutions, washing solutions or other medical or therapeutical solutions.

7. The container of claim 1, wherein the outlet port is configured for removing an effluent from the container.

8. The container of claim 1, wherein the inlet port operates as an outlet port for removing the viable cells for injection to a patient.

9. The container of claim 1, wherein the container is part of a system, the system containing at least a first syringe and a second syringe, wherein the first syringe and the second syringe are connected to the inlet port and outlet port respectively.

10. The container of claim 1, wherein the outlet port operates as an inlet port for a flushing fluid for flushing the viable cells out of the at least one filter.

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

an open top end, a closed bottom end, and a central axis extending between the open top end and the closed bottom end;

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

a first tubing having a distal end and extending through an end closure of the container enclosing the open top end, the first tubing extending toward the closed bottom end of the container;

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

a second tubing having a distal end extending through the end closure of the container toward the closed bottom end of the container, wherein the inlet port is disposed on the distal end of the first tubing and the outlet port is disposed on the distal end of the second tubing; and

a divider disposed within the container, the divider extending from the open top end toward the closed bottom end and spaced apart from the closed bottom end and defining an opening, the divider separating the container into a first fluid path on a first side of the divider through which fluid can enter the container through the inlet port and a second fluid path on a second side of the divider through which fluid can enter the opening and exit the container through the outlet port, the second fluid path including at least one filter through which fluid can pass from the first fluid path to the second fluid path but through which at least one component of the injectate cannot pass,

wherein, in use, 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 the closed bottom end of the container.

12. The container of claim 11, wherein at least one of the tubing comprises a spike and at least one of the cap and the end closure is a piercable septum.

13. The container of claim 11, 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.

14. The container of claim 11, wherein the container encompasses the viable cells within the first fluid and the at least one filter prevents the viable cells from passing therethrough.

15. The container of claim 11, wherein an interior surface of the closed bottom end of the container is rounded.

16. The container of claim 11, wherein the inlet port is configured for filling the container with buffer solutions, washing solutions or other medical or therapeutical solutions.

17. The container of claim 11, wherein the outlet port is configured for removing effluent from the container.

18. The container of claim 11, wherein the inlet port is configured for removing the viable cells for injection to a patient.

19. The container of claim 11, wherein the container is part of a system, the system containing at least a first syringe and a second syringe, wherein the first syringe and the second syringe are connected to the inlet port and outlet port respectively.

20. The container of claim 11, wherein the outlet port operates as an inlet port for a flushing fluid for flushing the viable cells out of the at least one filter.