Centrifuge bag-holding device with clamp assembly and uses thereof

• US 6,019,716 A
• Filed: 07/13/1998
• Issued: 02/01/2000
• Est. Priority Date: 07/13/1998
• Status: Expired due to Fees

• Current Assignee: Novartis Ag
• Original Assignee: Novartis Ag
• Inventors: Tushinski, Robert J., Bobrov, Yakov, Forestell, Sean, Rigg, Richard J.
• Primary Examiner(s): Cooley, Charles E.
• Application Number:
  US09/114,616
• Time in Patent Office: 568 Days
• Field of Search: 494/1, 494/17, 494/18, 494/20, 494/21, 494/31, 494/33, 494/37, 494/38, 494/45, 494/47, 494/60, 494/85, 210/781, 210/782
• US Class Current: 494/21
• CPC Class Codes: A61M 1/029 Separating blood components present in distinct layers in a container, not otherwise provided for containers for storing blood or blood components A61J1/05; sampling or analysing blood by separating blood components G01N33/491
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: B04B 2005/0435 with adapters for centrifuge tubes or bags
• CPC Class Codes: B04B 5/0428 with flexible receptacles

Abstract

A device is provided for use in a centrifuge to separate or isolate material (such as pelleted cells, particulates, aggregates, compounds, blood components, and the like) from the liquid in which they are suspended while limiting or preventing loss of any of the resulting separated or pelleted material during further manipulations. The device can be inserted into a standard centrifugation bucket in a centrifuge and holds a flexible centrifuge bag. The device includes at least one damp assembly, which includes a partition that is maintained in an open position during centrifugation and in a closed position at unit gravity, thus isolating separated or pelleted material at the bottom of the flexible bag in the device after centrifugation and preventing the isolated material from being disturbed during liquid changes and other manipulations. The invention also encompasses a method for isolating material in a centrifuge bag following centrifugation utilizing the flexible bag-holding device described herein, as well as a flexible bag to be used with the device.

Claims

1. A device for holding a flexible bag within a centrifuge bucket, the device comprising:

a. a housing;

b. a compartment within the housing for holding the flexible bag in place; and

c. at least one clamp assembly mounted on the housing, the clamp assembly comprising;

i. at least one movable partition for dividing the compartment into an upper section and a lower section when the partition is in a closed position;

ii. at least one actuator contacting the partition for transferring a control force to move the partition from the closed position in the compartment to an open position when the control force is applied and to move the partition from the open position to the closed position when the control force is removed; and

iii. at least one resilient member mounted to the partition and to the housing for maintaining the partition in the closed position when the control force is removed from the actuator.

2. A device according to claim 1 wherein the control force is centrifugal force.

3. A device according to claim 2 wherein the actuator is a lever with a load.

4. A device according to claim 1 wherein the resilient member is at least one coiled spring or at least one bar spring.

5. A device according to claim 1 wherein at least a portion of the housing comprises a bag bed, and said bag bed portion is separable from the housing.

6. A device according to claim 1 wherein the resilient member is at least one spring, the actuator is a lever with a load, and the control force is centrifugal force.

7. A method for isolating material in a centrifuge bag following centrifugation, the method comprising:

a) arranging and configuring a device for holding a flexible centrifuge bag within a centrifuge bucket such that the device comprises;

1) a housing,

2) a compartment within the housing for holding the flexible bag in place, and

3) at least one clamp assembly mounted on the housing, the clamp assembly comprising;

i) at least one movable partition for dividing the compartment of the device into an upper section and a lower section when the partition is in a closed position,

ii) at least one actuator contacting the partition for transferring a control force to move the partition from the closed position in the compartment to an open position when the control force is applied and to move the partition from the open position to the closed position when the control force is removed, and

iii) at least one resilient member mounted to the partition and to the housing for maintaining the partition in the closed position when the control force is removed from the actuator;

b) placing fluid containing the material to be isolated into the flexible centrifuge bag;

c) providing a control force to the actuator to move the partition in the clamp assembly to an open position in the compartment of the device;

d) directing the material to be isolated to the lower section of the flexible bag by centrifugation; and

e) removing the control force from the actuator to move the partition to a closed position in the compartment of the device, to isolate the material in the lower section of the centrifuge bag below the partition.

8. A method according to claim 7 wherein the control force is centrifugal force.

9. A method according to claim 8 wherein the actuator is a lever with a load.

10. A method according to claim 7 wherein the resilient member is at least one coiled spring or at least one bar spring.

11. A method according to claim 7 wherein the material to be isolated comprises cells.

12. A method according to claim 7 wherein at least a portion of the housing comprises a bag bed, and said bag bed portion is separable from the housing.

13. A method according to claim 7 wherein the resilient member is at least one spring, the actuator is a lever with a load, and the control force is centrifugal force.

14. A device for holding a flexible bag within a centrifuge bucket, the device comprising:

a. a housing comprising two sections;

b. a compartment within the housing for holding the flexible bag in place; and

c. a clamp assembly mounted on each section of the housing, each clamp assembly comprising;

i. at least one movable partition for dividing the compartment into an upper section and a lower section when the partition is in a closed position;

ii. at least one actuator contacting the partition for transferring a control force to move the partition from the closed position in the compartment to an open position when the control force is applied to the actuator; and

iii. at least one resilient member mounted to the partition and to the housing for maintaining the partition in the closed position when the control force is removed from the actuator.

15. A device according to claim 14 wherein the resilient member is a coiled spring or a bar spring.

16. A device according to claim 14 wherein the control force is centrifugal force.

17. A device according to claim 16 wherein the actuator is a lever with a load.

18. A device according to claim 14 wherein at least a portion of each section of the housing, comprising a bag bed, is separable from the housing.

19. A device according to claim 14 wherein the resilient member is at least one spring;

the actuator is a lever with a load; and

the control force is centrifugal force.

20. A device according to claim 19 wherein at least a portion of each section of the housing, comprising a bag bed, is separable from the housing.

21. A method for isolating material in a centrifuge bag following centrifugation, the method comprising:

a) arranging and configuring a device for holding a flexible centrifuge bag within a centrifuge bucket such that the device comprises;

1) a housing comprising two sections,

2) a compartment within the housing for holding the flexible bag in place, and

3) a clamp assembly mounted on each section of the housing, each clamp assembly comprising;

i) at least one movable partition for dividing the compartment of the device into an upper section and a lower section when the partition is in a closed position,

ii) at least one actuator contacting the partition for transferring a control force to move the partition from the closed position in the compartment to an open position when the control force is applied to the actuator, and

iii) at least one resilient member mounted to the partition and to the housing for maintaining the partition in the closed position when the control force is removed from the actuator;

b) placing fluid containing the material to be isolated into the flexible centrifuge bag;

c) providing a control force to the actuators to move the partitions in the clamp assemblies to an open position in the compartment of the device;

d) directing the material to be isolated to the lower section of the flexible bag by centrifugation; and

e) removing the control force from the actuators to move the partitions to a closed position in the compartment of the device, to isolate the material in the lower section of the centrifuge bag below the partitions.

22. A method according to claim 21 wherein the control force is centrifugal force.

23. A method according to claim 22 wherein the actuator is a lever with a load.

24. A method according to claim 21 wherein at least a portion of each section, comprising a bag bed, is separable from the housing.

25. A method according to claim 21 wherein the resilient member is at least one coiled spring or at least one bar spring.

26. A method according to claim 21 wherein the resilient member is at least one spring;

the actuator is a lever with a load; and

the control force is centrifugal force.

27. A method according to claim 26 wherein at least a portion of each section of the housing, comprising a bag bed, is separable from the housing.

28. A method according to claim 26 wherein the material to be isolated comprises cells.

29. A method according to claim 21 wherein the material to be isolated comprises cells.