Cell processing methods with process parameter control

Patent metadata

Field	Value
Publication number	US-11901068-B2
Application number	US-202117464325-A
Country	US
Kind code	B2
Filing date	Sep 1, 2021
Priority date	Mar 14, 2016
Publication date	Feb 13, 2024
Grant date	Feb 13, 2024

Abstract

A method of processing blood includes receiving from a touch screen user input data for a protocol for a wash procedure. The user input data includes a numeric value. The method includes storing the protocol in a memory, receiving an identifier from a user, determining if the identifier permits the user to modify the protocol and receiving a modification of the protocol from the user. The method includes providing a plurality of authorizations, a second authorization being a default and an administrator authorization permitting the user to change a setting. The method includes comparing a password to a password stored in memory and, if there is a match, determining that the password is associated with an administrator. If a command to change the setting is received, the command is applied to change the setting. The blood is processed employing a wash procedure using the modified protocol and the changed setting.

First claim

What is claimed is:

1. A method of washing cells using a cell washing system comprising a reusable processing machine having a touch screen, at least one pump and a panel, the cell washing system further comprising a disposable fluid circuit configured to be loaded on the panel, comprising:
permitting control of the reusable processing machine based on a hierarchy of authorizations comprising at least an administrator authorization and an operator authorization, the operator authorization having a lower level of authorization than the administrator authorization the operator authorization being assumed as a default;
receiving a password from the touch screen of the reusable processing machine;
comparing the received password to a list of passwords stored in a memory of the reusable processing machine to determine if the user has administrator authorization;
if the received password matches one of the passwords in the list, determining that the received password is associated with an administrator authorization;
applying a received command based on the match, the administrator authorization being the authorization that permits the command to be applied;
assuming as a default that the user has operator authorization unless the user attempts to enter the password, at which point it is determined if the user has the administrator authorization, the administrator authorization being the authorization that permits the received command to be applied;
receiving from the touch screen user input data for a plurality of protocols for storage in the memory of the reusable processing machine, each protocol comprising values for a set of process parameters for a wash procedure, wherein the user input data from the touch screen comprises a numeric value for a wash procedure parameter;
storing the numeric value of the wash procedure parameter as part of one of the protocols in the memory of the reusable processing machine;
receiving an identifier from a user via the touch screen;
determining if the identifier permits the user to modify the one of the protocols;
receiving a modification of the one of the protocols from the user via the touch screen if permitted, wherein the modification comprises a modification of the numeric value for the wash procedure parameter;
applying the one of the protocols with the modification of the numeric value of the wash procedure parameter for use with the reusable processing machine;
prompting an operator to load the disposable fluid circuit;
receiving the disposable fluid circuit on the panel of the reusable processing machine; and
operating the wash procedure using the applied one of the protocols to receive biological fluid from a biological fluid container and wash solution from a wash medium container in a separator device, to separate red blood cells from a waste solution comprising free hemoglobin, and to dispense the waste solution to a waste product container.

2. The method of washing cells of claim 1 , wherein the values for the set of process parameters are default values.

3. The method of washing cells of claim 1 , further comprising determining whether the disposable fluid circuit is properly installed and, if so, confirming installation of the disposable fluid circuit.

4. The method of washing cells of claim 3 , further comprising communicating with a remote server over a network.

5. The method of washing cells of claim 2 , wherein the default values are modifiable by a user.

6. The method of washing cells of claim 1 , wherein the prestored protocol is received from a portable memory storage device or a server.

7. The method of washing cells of claim 1 , wherein the prestored protocol comprises an amount of cell suspension to be washed or the number of washings to take place.

8. A method of washing cells using a disposable fluid circuit and a reusable processing machine having a touch screen and at least one pump, comprising:
permitting control of the reusable processing machine based on a hierarchy of authorizations comprising at least two different levels of authorization comprising an administrator authorization and a non-administrator authorization, the non-administrator authorization having a lower level of authorization than the administrator authorization, wherein the administrator authorization permits the user to modify a setting;
determining a user has the non-administrator authorization unless the user enters a password associated with an administrator, at which point the method determines the user has an administrator authorization, wherein the determining comprises assuming as a default that the user has the non-administrator authorization unless the user attempts to enter the password, at which point it is determined if the user has the administrator authorization, the administrator authorization being the authorization that permits the user to modify the setting
receiving from a touch screen user input data for a plurality of protocols for storage in a memory of the reusable processing machine, each protocol comprising values for a set of process parameters for a wash procedure, wherein the user input data received from the touch screen comprises a numeric value for a wash procedure parameter between a minimum value and a maximum value for one of the process parameters of the protocol;
storing one of the plurality of protocols having the numeric value of the wash procedure parameter in the memory of the reusable processing machine;
receiving a password from a user via the touch screen of the reusable processing machine;
determining if the password is associated with an authorization for the user;
receiving a modification of the one of the plurality of protocols from the user via the touch screen, wherein the modification comprises a modification of the numeric value of the wash procedure parameter;
prompting an operator to load the disposable fluid circuit;
receiving the disposable fluid circuit on the reusable processing machine; and
processing blood using the one of the plurality of protocols comprising the wash procedure having the modification of the numeric value by receiving blood and a wash solution, separating red blood cells from a waste solution comprising free hemoglobin, and dispensing the waste solution to a waste product container.

9. The method of washing cells of claim 8 , wherein the minimum value and maximum value are user-defined.

10. The method of washing cells of claim 9 , wherein the values for the set of process parameters are default values.

11. The method of washing cells of claim 8 , wherein the setting comprises a process parameter defining a wash volume.

12. The method of washing cells of claim 8 , wherein the setting comprises a flow rate.

13. The method of washing cells of claim 8 , further comprising preventing modification of the numeric value without authorization provided by the password.

14. The method of washing cells of claim 8 , wherein the modified numeric value comprises an amount of cell suspension to be washed or the number of washings to take place.

15. A method of processing blood using a cell washing system comprising a reusable processing machine having a touch screen, at least one pump and a panel, the cell washing system further comprising a disposable fluid circuit configured to be loaded on the panel, comprising:
receiving from the touch screen user input data for a plurality of protocols for storage in a memory of the reusable processing machine, each protocol comprising values for a set of process parameters for a wash procedure, wherein the user input data received from the touch screen comprises a

Assignees

• Fenwal Inc

Inventors

• Binninger Steven
• Wegener Christopher J
• Schlinker Alaina
• Olson Bret M

Classifications

• G16H40/63 Primary

  for local operation · CPC title

• A61M1/265

  inducing Taylor vortices · CPC title

• A61M1/3692

  Washing or rinsing blood or blood constituents · CPC title

• G05B13/024

  in which a parameter or coefficient is automatically adjusted to optimise the performance · CPC title

• G16H10/40

  for data related to laboratory analysis, e.g. patient specimen analysis · CPC title