CELL PROCESSING SYSTEM AND METHOD WITH PRELIMINARY PROCESS EVALUATION

• US 20170340783A1
• Filed: 03/13/2017
• Published: 11/30/2017
• Est. Priority Date: 05/27/2016
• Status: Active Grant

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Wegener, Christopher J., Boggs, Daniel, Olson, Bret M., Binninger, Steven C., Hosek, James D.
• Granted Patent: US 11,191,879 B2
• Time in Patent Office: Days
• CPC Class Codes: A61M 1/00 Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems catheters A61M25/00; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; devices for taking samples of blood A61B5/15; filters implantable into blood vessels A61F2/01
• CPC Class Codes: A61M 1/0272 Apparatus for treatment of blood or blood constituents prior to or for conservation, e.g. freezing, drying or centrifuging
• CPC Class Codes: A61M 1/262 rotating
• CPC Class Codes: A61M 1/265 inducing Taylor vortices
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3692 Washing or rinsing blood or blood constituents
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/75 with filters
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis

Abstract

A cell processing system includes a processor connectable to a source container filled with a biological fluid, the processor including a separator configured to separate the biological fluid from the source container into at least two streams according to a process including at least one process parameter, and a controller coupled to the processor and an input. The controller is configured to receive the at least one process parameter, to evaluate the process using the at least one process parameter before performing the process, and to carry out one or more actions based on the evaluation, such as providing an output estimate to the operator, preventing the process from being performed according to a comparison between a calculated condition and a control, or providing an error indication to the operator according to the calculated condition and a measured in-process condition.

Claims

1. A cell processing system comprising:

a processor connectable to a source container filled with a biological fluid, the processor including a separator configured to separate the biological fluid from the source container into at least two streams according to a process including at least one process parameter; and

a controller coupled to the processor and an input, the controller configured;

to receive the at least one process parameter via the input;

to calculate at least one output based on the at least one process parameter;

to provide the at least one calculated output to an operator prior to causing the processor to operate according to the process.

2. The cell processing system according to claim 1, wherein the at least one calculated output comprises a time to complete the process, or a part thereof, a volume of wash media consumed, a volume of waste fluid generated, and a volume of a residual remaining in a product.

3. The cell processing system according to claim 1, wherein the controller is configured:

to calculate the at least output based on the at least one process parameter and each step of the process.

4. A cell processing system comprising:

a processor connectable to a source container filled with a biological fluid, the processor including a separator configured to separate the biological fluid from the source container into at least two streams according to a process including at least one process parameter; and

a controller coupled to the processor and an input, the controller configured;

to receive the at least one process parameter via the input;

to calculate at least one in-process condition based on the at least one process parameter;

to compare the at least one calculated in-process condition with at least one in-process condition control; and

to provide an error indication to an operator if the at least one calculated in-process condition does not match the at least one in-process condition control prior to causing the processor to operate according to the process.

5. The cell processing system according to claim 4, wherein the controller is configured:

to calculate a plurality of in-process conditions corresponding to each step that defines the process;

to compare a set of the plurality of calculated in-process conditions with a set of in-process condition controls; and

to provide an error indication to the operator if any element of the set of calculated in-process conditions does not match a corresponding element of the set of in-process condition controls.

6. A cell processing system comprising:

a processor connectable to a source container filled with a biological fluid, the processor including a separator configured to separate the biological fluid from the source container into at least two streams according to a process including at least one process parameter; and

a controller coupled to the processor and an input, the controller configured;

to receive the at least one process parameter via the input;

to calculate at least one in-process condition based on the at least one process parameter prior to causing the processor to operate according to the process;

to subsequently cause the processor to operate according to the process;

to measure at least one in-process condition during operation of the processor;

to compare the at least one calculated in-process condition with at least one measured in-process condition; and

to provide an error indication to an operator if the at least one measured in-process condition does not match the at least one calculated in-process condition.

7. The cell processing system according to claim 6, wherein the controller is configured:

to calculate a plurality of in-process conditions corresponding to each step that defines the process prior to causing the processor to operate according to the process;

to compare a set of the plurality of calculated in-process conditions with a set of measured in-process conditions; and

to provide an error indication to the operator if any element of the set of measured in-process conditions does not match a corresponding element of the set of calculated in-process conditions.

8. The cell processing system according to claim 7, 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. A method for evaluating a process, the process to be performed using a processor connectable to a source container filled with a biological fluid, the processor including a separator configured to separate the biological fluid from the source container into at least two streams, the method comprising:

receiving at least one process parameter to be used during the process;

calculating at least one output based on the at least one process parameter;

providing the at least one calculated output to an operator prior to operating the processor according to the process.

11. The method according to claim 10, wherein the at least one calculated output comprises a time to complete the process, or a part thereof, a volume of wash media consumed, a volume of waste fluid generated, and a volume of a residual remaining in a product.

12. The method according to claim 10, wherein calculating at least one output comprises calculating the at least output based on the at least one process parameter and each step of the process.

13. A method for evaluating a process, the process to be performed using a processor connectable to a source container filled with a biological fluid, the processor including a separator configured to separate the biological fluid from the source container into at least two streams, the method comprising:

receiving at least one process parameter to be used during the process;

calculating at least one in-process condition based on the at least one process parameter;

comparing the at least one calculated in-process condition with at least one in-process condition control; and

providing an error indication to an operator if the at least one calculated in-process condition does not match the at least one in-process condition control prior to operating the processor according to the process.

14. The cell processing system according to claim 13, further comprising:

calculating a plurality of in-process conditions corresponding to each step that defines the process;

comparing a set of the plurality of calculated in-process conditions with a set of in-process condition controls; and

providing an error indication to the operator if any element of the set of calculated in-process conditions does not match a corresponding element of the set of in-process condition controls.

15. A method for evaluating a process, the process to be performed using a processor connectable to a source container filled with a biological fluid, the processor including a separator configured to separate the biological fluid from the source container into at least two streams, the method comprising:

receiving at least one process parameter to be used during the process;

calculating at least one in-process condition based on the at least one process parameter prior to operating the processor according to the process;

causing subsequently the processor to operate according to the process;

measuring at least one in-process condition during operation of the processor;

comparing the at least one calculated in-process condition with at least one measured in-process condition; and

providing an error indication to an operator if the at least one measured in-process condition does not match the at least one calculated in-process condition.

16. The method according to claim 15, further comprising:

calculating a plurality of in-process conditions corresponding to each step that defines the process prior to causing the processor to operate according to the process;

comparing a set of the plurality of calculated in-process conditions with a set of measured in-process conditions; and

providing an error indication to the operator if any element of the set of measured in-process conditions does not match a corresponding element of the set of calculated in-process conditions.