CELL PROCESSING SYSTEM AND METHOD WITH PROCESS PARAMETER CONTROL

• US 20170262601A1
• Filed: 03/13/2017
• Published: 09/14/2017
• Est. Priority Date: 03/14/2016
• Status: Active Grant

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Binninger, Steven, Wegener, Christopher J., Schlinker, Alaina, Olson, Bret M.
• Granted Patent: US 11,139,074 B2
• Time in Patent Office: Days
• CPC Class Codes: A61M 1/265 inducing Taylor vortices
• CPC Class Codes: A61M 1/3692 Washing or rinsing blood or blood constituents
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/60 with identification means
• CPC Class Codes: G05B 13/024 in which a parameter or coefficient is automatically adjusted to optimise the performance
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A cell processing system includes a processor to receive a biological fluid to be processed, a controller coupled to the processor, the controller configured to operate the processor according to at least one modifiable process parameter, and at least one input coupled to the controller, the at least one input configured to receive an identifier and at least one process parameter control associated with the at least one process parameter that limits modification of the at least one process parameter if applied. The controller is configured to determine if the identifier is associated with an administrator authorization and to apply the at least one processor parameter control to the at least one process parameter if the identifier is associated with an administrator authorization.

Claims

1. A cell processing system comprising:

a processor to receive a biological fluid to be processed;

a controller coupled to the processor, the controller configured to operate the processor according to at least one modifiable process parameter;

at least one input coupled to the controller, the at least one input configured to receive an identifier and at least one process parameter control associated with the at least one process parameter that limits modification of the at least one process parameter if applied,

the controller configured to determine if the identifier is associated with an administrator authorization and to apply the at least one processor parameter control to the at least one process parameter if the identifier is associated with an administrator authorization.

2. The cell processing system according to claim 1, wherein the identifier comprises a password.

3. The cell processing system according to claim 1, wherein the at least one modifiable process parameter comprises a numeric value, and the at least one process parameter control comprises at least one of a minimum value and a maximum value.

4. The cell processing system according to claim 1, wherein the at least one process parameter control prevents modification of the at least one process parameter without an identifier associated with an administrator authorization.

5. The cell processing system according to claim 1, wherein the controller is configured to receive a protocol comprising a plurality of process parameter controls, and the controller applies the process parameter controls of the protocol if the identifier is associated with an administrator authorization.

6. The cell processing system according to claim 5, wherein the at least one input receives the protocol from another cell processing system in communication with the cell processing system.

7. The cell processing system according to claim 1, wherein the controller comprises a microprocessor, the microprocessor programmed to determine if the identifier is associated with an administrator authorization and to apply the processor parameter control to the at least one process parameter if the identifier is associated with an administrator authorization.

8. The cell processing system according to claim 1, wherein the processor comprises a disposable fluid circuit and reusable hardware.

9. The cell processing system according to claim 8, wherein the disposable fluid circuit comprises a spinning membrane separation device, at least one container, and tubing connecting the spinning membrane and the one or more containers.

10. The cell processing system according to claim 8, wherein the reusable hardware includes at least one drive to spin the spinning membrane, at least one scale to weigh the at least container and contents thereof, and at least one pump.

11. A method of operating a cell processing system, the cell processing system comprising a processor to receive a biological fluid to be processed and to be operated according to at least one modifiable process parameter, the method comprising:

receiving an identifier and at least one process parameter control associated with the at least one process parameter that limits modification of the at least one process parameter if applied;

determining if the identifier is associated with an administrator authorization;

applying the at least one processor control to the at least one process parameter if the identifier is associated with an administrator authorization; and

processing the biological fluid employing a process that includes the at least one process parameter.

12. The method according to claim 11, wherein receiving an identifier comprises receiving a password.

13. The method according to claim 11, wherein the at least one modifiable process parameter comprises a numeric value, and applying the at least one process parameter control comprises applying at least one of a minimum value and a maximum value.

14. The method according to claim 11, wherein applying the at least one process parameter control comprises preventing modification of the at least one process parameter without an identifier associated with an administrator authorization.

15. The method according to claim 11, wherein receiving at least one process parameter control comprises receiving a protocol comprising a plurality of process parameter controls, and applying at least one process parameter control comprises the process parameter controls of the protocol if the identifier is associated with an administrator authorization.

16. The method according to claim 11, wherein receiving the protocol comprises receiving the protocol from another cell processing system in communication with the cell processing system.

17. A network of cell processing systems, comprising:

at least one cell processing system, the at least one cell processing system comprising;

a processor to receive a biological fluid to be processed;

a controller coupled to the processor, the controller configured to operate the processor according to at least one modifiable process parameter; and

at least one input coupled to the controller, the at least one input configured to receive at least one process parameter control associated with the at least one process parameter that limits modification of the at least one process parameter if applied,

a non-transitory computer-readable memory storage device coupled to the at least one cell processing system, the memory storage device including a plurality of process parameter controls stored therein and configured to transmit one or more process parameter controls to the at least one cell processing system,

wherein one of the controller and the memory storage device is configured to receive an identifier and to determine if the identifier is associated with an administrator authorization, and the controller is configured to apply the at least one processor parameter control to the at least one process parameter if the identifier is associated with an administrator authorization.

18. The network of cell processing systems according to claim 17, wherein the memory storage device is configured to receive the identifier and to determine if the identifier is associated with an administrator authorization, the memory storage device configured to transmit at least one process parameter control associated with the at least one process parameter to the at least one input only if the identifier is associated with an administrator authorization.

19. The network of cell processing systems according to claim 17, wherein one or more protocols are stored in the memory storage device, each protocol comprising a plurality of process parameter controls.

20. The network of cell processing systems according to claim 19, wherein the one or more protocols are transmitted from one or more of the cell processing systems to the memory storage device.