Cell processing system and method with preliminary process evaluation

Patent metadata

Field	Value
Publication number	US-11672891-B2
Application number	US-202117398780-A
Country	US
Kind code	B2
Filing date	Aug 10, 2021
Priority date	May 27, 2016
Publication date	Jun 13, 2023
Grant date	Jun 13, 2023

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.

First claim

The invention claimed is:

1. A blood processing system comprising:
a blood processing apparatus comprising reusable hardware and a disposable fluid circuit, the blood processing apparatus comprising a separator configured to perform a centrifugal separation process on a biological fluid from a source to provide a blood component in a product container, the reusable hardware comprising a weight scale configured to weigh the product container and an air detector sensor;
a touch screen configured to receive input from an operator;
a transmitter/receiver device configured to communicate over a network and to receive process parameters from a server computer; and
a processing circuit coupled to the blood processing apparatus and the network, the processing circuit configured to receive the process parameters from the server computer and store them in a memory, the processing circuit configured to store default process parameters in the memory, the processing circuit configured to:
receive an activation from the operator to switch on the blood processing system;
conduct self-checks on the blood processing apparatus;
receive input data for a value of a process parameter from the touch screen;
verify that the value is within a preset range for the value;
prior to operating the blood processing apparatus according to a centrifugal separation process, store a pre-process calculation of a volume of the blood component to be collected in the product container and provide an indication of the volume to an operator via the touch screen;
prompt the operator to mount the disposable fluid circuit;
automatically check to determine whether the disposable fluid circuit is installed;
prime tubing of the disposable fluid circuit with a fluid;
commence the centrifugal separation process on the biological fluid;
check the air detector sensor for a fluid/air interface;
weigh the product container during the centrifugal separation process;
process the biological fluid until the volume of the blood component to be collected is collected; and
upon completion of the centrifugal separation process, prompt the operator.

2. The blood processing system of claim 1 , further comprising a barcode reader, wherein the processing circuit is further configured to receive input data for a value for a second process parameter from a barcode reader.

3. The blood processing system of claim 1 , wherein the disposable fluid circuit comprises a saline access site.

4. The blood processing system of claim 1 , wherein the blood component to be collected is blood cells.

5. A blood processing system comprising:
a blood processing apparatus comprising reusable hardware and a disposable fluid circuit, the blood processing apparatus comprising a separator configured to perform a centrifugal separation process on a biological fluid from a source to provide a blood component in a product container, the reusable hardware comprising a weight scale configured to weigh the product container and an air detector sensor;
a touch screen configured to receive input from an operator;
a transmitter/receiver device configured to communicate over a network and to receive data from a server computer; and
a processing circuit coupled to the blood processing apparatus and the network, the processing circuit configured to receive the data from the server computer and store the data in a memory, the processing circuit configured to store default process parameters in the memory, the processing circuit configured to:
receive an instruction from the operator to activate the blood processing system;
conduct self-checks on the blood processing apparatus;
receive input data for a value of a process parameter from the touch screen;
verify that the value is within a preset range for the value;
prior to operating the blood processing apparatus according to a centrifugal separation process, store a pre-process calculation of a volume of the blood component to be collected in the product container based at least in part on the value of the process parameter received from the touch screen;
provide an indication of the volume to be collected to an operator via the touch screen;
prompt the operator to mount the disposable fluid circuit;
automatically check to determine whether the disposable fluid circuit is installed;
prime tubing of the disposable fluid circuit with a fluid;
commence the centrifugal separation process on the biological fluid;
check the air detector sensor for a fluid/air interface;
weigh the product container during the centrifugal separation process;
process the biological fluid until the volume of the blood component to be collected is collected.

6. The blood processing system of claim 5 , wherein the processing circuit is further configured to, upon completion of the centrifugal separation process, prompt the operator.

7. The blood processing system of claim 5 , wherein the pre-process calculation is based at least in part on one of the default process parameters stored in the memory.

8. The blood processing system of claim 5 , wherein the pre-process calculation is based at least in part on the data received from the server computer.

9. The blood processing system of claim 5 , further comprising a barcode reader, wherein the processing circuit is further configured to receive input data for a value for a second process parameter from a barcode reader.

10. The blood processing system of claim 5 , wherein the blood component to be collected is blood cells.

11. A blood processing system comprising:
a blood processing apparatus comprising reusable hardware and a disposable fluid circuit, the blood processing apparatus comprising a separator configured to perform a centrifugal separation process on a biological fluid from a source to provide a blood component to a product container, the reusable hardware comprising a weight scale configured to weigh the product container and an air detector sensor;
a touch screen configured to receive input from an operator; and
a control unit coupled to the blood processing apparatus, the control unit configured to store default process parameters in the memory, the control unit configured to:
receive an instruction from the operator to activate the blood processing system;
conduct self-checks on the blood processing apparatus;
receive input data for a value of a process parameter from the touch screen;
prior to operating the blood processing apparatus according to a centrifugal separation process, calculate a volume of the blood component to be collected in the product container based at least in part on the value of the process parameter received from the touch screen;
provide an indication of the volume to be collected to an operator via the touch screen;
prime tubing of the disposable fluid circuit with a fluid;
commence the centrifugal separation process on the biological fluid using the default process parameters;
check the air detector sensor for a fluid/air interface;
weigh the product container during the centrifugal separation process;
process the biological fluid to collect the volume of the blood component to be collected.

12. The blood processing system of claim 11 , wherein the control unit is further configured to verify that the value is within a preset range for the value.

13. The blood processing system of claim 11 , further comprising a transmitter/receiver device configured to communicate over a network and to receive data from a server computer, the control unit configured to receive the data from the server computer and store the data in a memory.

14. The blood processing system of c

Assignees

• Fenwal Inc

Inventors

• Wegener Christopher J
• Boggs Daniel
• Olson Bret M
• Binninger Steven C
• Hosek James D

Classifications

• A61M1/3692

  Washing or rinsing blood or blood constituents · CPC title

• A61M1/0272 Primary

  Apparatus for treatment of blood or blood constituents prior to or for conservation, e.g. freezing, drying or centrifuging · CPC title

• A61M2205/75

  with filters · CPC title

• A61M1/3693

  using separation based on different densities of components, e.g. centrifuging · CPC title

• A61M1/265

  inducing Taylor vortices · CPC title