IP Library Granted Patent US 12,110,482
Granted Patent B2
US 12,110,482 · App. 18/049,180 · Granted Oct 8, 2024

Instruments for processing cells

Inventors: Weston Blaine Griffin (Niskayuna, NY); Mark Robert Timmins (Marlborough, MA); Dan Harris (Merrimack, NH); Spencer Lovette (Merrimack, NH); Jim Dowling (Merrimack, NH); Dan O'Sullivan (Hollis, NH); David Robinson (Burlington, MA)
Assignee: Global Life Sciences Solutions USA LLC
C12M41/48C12M23/00C12M23/28C12M23/40C12M29/00C12M29/14C12M41/00C12M41/44C12M47/02C12M47/12
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Quick Facts
Patent No.
US 12,110,482
App. No.
18/049,180
Granted
Oct 8, 2024
Kind
B2
Abstract

Disclosed herein is an instrument suitable for processing cells for example culturing, concentrating or washing said cells, the instrument comprising: a housing for accommodating mechanical elements including at least one fluid pump; and a disposable processing kit complementary to the mechanical elements within the housing and comprising a fluid circuit including a fluid reservoir and plural fluid paths capable of carrying fluid flow caused by said pump(s), the instrument further including a mechanism for determining the quantity, or change in quantity of the fluid in the reservoir resulting from said fluid flow, the instrument yet further comprising a controller operable to control at least the pump and operable to perform a fault determination process, which includes the steps of determining the expected flow rate of said pump(s) calculated from the speed of the pump(s) and comparing that expected flow with the change in quantity of the fluid in the reservoir as determined by said mechanism.

Claims (185)

1. An instrument for processing cells including culturing, concentrating or washing said cells that is adaptable to receive a disposable processing kit comprising a fluid circuit including a fluid reservoir and at least one fluid path, the instrument comprising:

a housing including at least one pump that is adaptable to receive the disposable processing kit and provide fluid flow, by the at least one fluid pump, to the at least one fluid path;

a mechanism configured for determining a quantity or change in quantity of a fluid in the reservoir, and

a controller programmed to control said at least one fluid pump and operable to perform a fault determination process, which includes steps of:

determining an expected flow rate of said at least one fluid pump calculated from the speed of said at least one fluid pump;

comparing the expected flow rate with the change in quantity of the fluid in the reservoir; and

producing an error or fault condition based at least in part on a determination that said comparison produces a difference above a predetermined value.

2. The instrument of claim 1 , wherein the predetermined value is dependent on an average pump speed over the time period.

3. The instrument of claim 2 , wherein the predetermined value increases with pump speed.

4. The instrument of claim 1 , wherein said quantity is fluid mass and said mechanism is a weighing mechanism.

5. The instrument of claim 4 , wherein said weighing mechanism includes a load cell and a support mechanically connected to the load cell for supporting the fluid reservoir and for transferring the weight of the fluid reservoir to the load cell.

6. The instrument of claim 1 , wherein said quantity is fluid volume and said mechanism determines fluid volume.

7. The instrument of claim 1 , wherein said at least one fluid pump includes a peristaltic mechanism acting on a sealed fluid tube of the processing kit circuit, and the expected mass flow from said at least one fluid pump is calculated from the speed of the peristaltic mechanism.

8. The instrument of claim 1 , wherein said disposable processing kit is insertable into and removable from the housing as an assembly.

9. The instrument of claim 1 , wherein the instrument is operable to derived the error or fault condition from equations 1 and 2, where appropriate substituting volume for mass in said equations

Absolute Value(Expected Flow Rate-Actual Flow Rate)>  Error Criterion, Equation 1

wherein the Actual Mass Flow Rate is determined by the change in the signal from the load cell over the fixed measurement period, N seconds and

Equation 2—used to compute the flow rate error check:

Abs

[

0

N

1

/

fs

(

Actual

PumpSpeed

Dependent

Pump

)

N

1

/

fs

×

γ

DependentPump

+

0

N

1

/

fs

(

Actual

PumpSpeed

PrimaryIndependent

Pump

)

N

1

/

fs

×

γ

PrimaryIndependentPump

-

(

Mass

N

-

Mass

0

)

N

*

min

/

60

sec

]

>

Error

Criterion

where:

N is the measurement period in seconds (a configuration parameter):

fs is the measurement sample frequency in Hz,

thus

N

1

/

fs

is the number of samples in the measurement period:

Actual pump speed is in RPM:

Dependent Pump and Independent Pump subscripts designate different pumps controlled by the controller:

γ (Gamma) is the pump constant in ml/min/RPM:

Mass N is the mass at sample N during the integration period; and

Mass 0 is the starting mass.

10. A method for determining fluid mass or volumetric flow faults in the instrument for processing cells of claim 1 , the method comprising:

determining the expected flow rate of the at least one fluid pump calculated from the speed of said at least one fluid pump;

determining the quantity or change in quantity of the fluid in the reservoir;

comparing the expected flow rate with the change in quantity of the fluid in the fluid reservoir; and

producing the error or fault condition based at least in part on the determination that said comparison produces the difference above the predetermined value.

11. The method of claim 10 , wherein the error or fault condition is derived from equations 1 and 2, where appropriate substituting volume for mass in said equations

Absolute Value (Expected Flow Rate-Actual Flow Rate)>Error Criterion,  Equation 1

wherein the Actual Mass Flow Rate is determined by the change in the signal from the load cell over the fixed measurement period, N seconds and

Equation 2-used to compute the flow rate error check:

Abs

[

0

N

1

/

fs

(

Actual

PumpSpeed

Dependent

Pump

)

N

1

/

fs

×

γ

DependentPump

+

0

N

1

/

fs

(

Actual

PumpSpeed

PrimaryIndependent

Pump

)

N

1

/

fs

×

γ

PrimaryIndependentPump

-

(

Mass

N

-

Mass

0

)

N

*

min

/

60

sec

]

>

Error

Criterion

where:

N is the measurement period in seconds (a configuration parameter):

fs is the measurement sample frequency in Hz,

thus

N

1

/

fs

is the number of samples in the measurement period:

Actual pump speed is in RPM:

Dependent Pump and Independent Pump subscripts designate different pumps controlled by the controller:

γ (Gamma) is the pump constant in ml/min/RPM:

Mass N is the mass at sample N during the integration period; and Mass 0 is the starting mass.

12. The method of claim 10 , wherein the cells are human cells or non-human cells.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 24, 2022
From: GRIFFIN, WESTON B.; TIMMINS, MARK R.; LOVETTE, SPENCER; ROBINSON, DAVID; HARRIS, DAN; DOWLING, JIM; O'SULLIVAN, DAN
To: GE HEALTHCARE BIO-SCIENCES CORP
Reel/Frame 061519/0126 →
CHANGE OF NAME Recorded Oct 24, 2022
From: GE HEALTHCARE BIO-SCIENCES CORP
To: GLOBAL LIFE SCIENCES SOLUTIONS USA LLC
Reel/Frame 061758/0748 →
Continuity (4)
Continuation 16065642
Provisional Application 62346009 · Jun 6, 2016
Provisional Application 62270915 · Dec 22, 2015
Related Publication 20230060399A1 · Mar 2, 2023