System and Method for Controlling Outlet Flow of a Device for Separating Cellular Suspensions

Patent metadata

Field	Value
Publication number	US-2020261851-A1
Application number	US-202016869968-A
Country	US
Kind code	A1
Filing date	May 8, 2020
Priority date	Feb 22, 2017
Publication date	Aug 20, 2020
Grant date	—

Abstract

A system for separating a suspension of biological cells is disclosed comprising a single-use fluid circuit and a durable hardware component. The fluid circuit comprises a separator having a housing that includes an inlet for introducing the suspension of biological cells into the gap, a first outlet in communication with the gap for flowing a first type of cells from the separator, and a second outlet in communication with the second side of the filter membrane for flowing a second type of cells from the separator. The hardware component comprises a pump for flowing the suspension of biological cells to the inlet of the separator and at least one flow control device associated with the first outlet and the second outlet of the separator for selectively opening and closing the outlets so as to permit one of the first type of cells and the second type of cells to flow out of the separator in accordance with a predetermined duty cycle equal to the ratio of a target flow rate of first type of cells through the first outlet to the predetermined inlet flow rate.

First claim

1 . A method for separating a suspension of biological cells comprising at least one type of cells suspended in a non-cellular fluid using a system comprising a fluid circuit comprising a separator having a housing with an inlet for introducing the suspension of biological cells into the separator, a first outlet in communication with the separator for flowing the cells from the separator and a second outlet in communication with separator for flowing the non-cellular fluid from the separator, and a hardware component comprising a pump for flowing the suspension of biological cells to the inlet of the separator, at least one flow control device associated with the first outlet and the second outlet of the separator for selectively opening and closing the first and second outlets so as to permit the cells and the non-cellular fluid to flow out of the separator, the method comprising:
a) operating the pump so as to flow the suspension of biological cells to the inlet of the separator at a predetermined inlet flow rate; and b) alternately opening and closing the flow control device in accordance with a predetermined duty cycle.

2 . The method of claim 1 further comprising alternately opening and closing the flow control device such that the duty cycle is equal to the ratio of a target flow rate of the first type of cells through the first outlet to the predetermined inlet flow rate.

3 . The method of claim 2 further comprising determining the target flow rate of first type of cells as the product of the inlet flow rate times the ratio of cell concentration of the suspension of biological cells to a target cell concentration of the first type of cells.

4 . The method of any one of claim 1 further comprising alternately opening and closing the flow control device at a predetermined frequency.

5 . The method of claim 4 further comprising establishing the predetermined frequency for the duty cycle based on the concentration of cells in the suspension of biological cells being separated.

6 . The method of claim 5 further comprising establishing the predetermined frequency for the duty cycle as directly proportional to the concentration of cells in the suspension of biological cells being separated.

7 . A system for separating a suspension of biological cells comprising at least one type of cells suspended in a non-cellular fluid, the system comprising:
a) a fluid circuit comprising separator having a housing with an inlet for introducing the suspension of biological cells into the gap, a first outlet for flowing the cells from the separator and a second outlet for flowing the non-cellular fluid from the separator; b) a hardware component comprising a pump for flowing the suspension of biological cells to the inlet of the separator, at least one flow control device associated with the first outlet and the second outlet of the separator for selectively opening and closing the first and second outlets so as to permit the of cells and the the non-cellular fluid to flow out of the separator, and a programmable controller configured to operate the pump so as to flow the suspension of biological cells to the inlet of the separator at a predetermined inlet flow rate and to alternately open and close the flow control device in accordance with a predetermined duty cycle.

8 . The system of claim 7 wherein the programmable controller is configured to alternately open and close the flow control device such that the duty cycle is equal to the ratio of a target flow rate of first type of cells through the first outlet to the predetermined inlet flow rate.

9 . The system of claim 8 wherein the programmable controller is further configured to determine the target flow rate of the first type of cells as the product of the inlet flow rate times the ratio of cell concentration of the suspension of biological cells to a target cell concentration of the first type of cells.

10 . The system of any one of claim 7 wherein the programmable controller is further configured to alternately open and close the flow control device at a predetermined frequency.

11 . The system of claim 10 wherein the programmable controller is further configured to establish the predetermined frequency for the duty cycle based on the concentration of cells in the suspension of biological cells being separated.

12 . The system of claim 11 wherein the predetermined frequency for the duty cycle is directly proportional to the concentration of cells in the suspension of biological cells being separated.

13 . The system of claim 7 wherein the flow control device is a clamp associated with each of the first and second outlets of the separator.

14 . The system of claim 7 wherein the flow control device is a two position stopcock associated with both of the first and second outlets of the separator.

15 . The system of claim 7 wherein the fluid circuit comprises spinning membrane separator having a housing and a filter membrane having a first side and a second side, a gap being defined between the housing and the first side of the filter membrane and a flow path in fluid communication with the second side of the filter membrane, an inlet for introducing the suspension of biological cells into the gap, a first outlet in communication with the gap for flowing the first type of cells from the separator and a second outlet in communication with the second side of the filter membrane for flowing the second type of cells from the separator.

16 . The method of claim 1 wherein the non-cellular fluid comprises plasma.

17 . The method of claim 1 wherein the suspension of biological cells further comprises a second type of cells that flows out of the second outlet together with the non-cellular fluid.

18 . The system of claim 7 wherein the non-cellular fluid comprises plasma.

19 . The system of claim 7 wherein the suspension of biological cells further comprises a second type of cells that flows out of the second outlet together with the non-cellular fluid.

Assignees

• Fenwal Inc

Inventors

• Brown Richard I
• Kusters Benjamin E
• Min Kyungyoon

Classifications

• B01D15/18 Primary

  relating to flow patterns · CPC title

• B01D2313/18

  Specific valves · CPC title

• B01D2315/10

  Cross-flow filtration · CPC title

• A61M1/3403

  Regulation parameters · CPC title

• B01D2315/18

  Time sequence of one or more process steps carried out periodically within one apparatus · CPC title