# US 11,994,509 B2 · Collecting components of a fluid

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- Number: US 11,994,509 B2
- Document ID: US11994509B2
- Status: Granted
- Kind: B2
- Application number: 17/745,352
- Filed: 2022-05-16
- Published: 2022-09-01
- Granted: 2024-05-28
- Earliest claimed: 2016-10-13
- Assignees: Terumo BCT, Inc.
- Applicants: Terumo BCT, Inc.
- Inventors: Marlene Bainbridge; Todd Curtis Green; Logan Fender
- Web page: https://patentgrep.com/patent/US11994509B2

## CPC

- G01N 33/491: {by separating the blood components (G01N15/05 takes precedence)}
- A61M 1/3693: {using separation based on different densities of components, e.g. centrifuging}
- A61M 1/3696: {with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation}
- B01D 21/2472: {Means for fluidising the sediments, e.g. by jets or mechanical agitators}
- B01D 21/262: {by using a centrifuge}
- B01D 21/34: Controlling the feed distribution; Controlling the liquid level {; Control of process parameters}
- B04B 5/0442: {with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation}
- A61M 1/362227: {the interface providing means for actuating on functional elements of the cassette, e.g. plungers}
- A61M 1/36225: {with blood pumping means or components thereof}
- A61M 2202/0021: removed from and reintroduced into the body, e.g. after treatment
- A61M 2202/0427: Platelets; Thrombocytes
- A61M 2202/0439: White blood cells; Leucocytes
- A61M 2205/3334: Measuring or controlling the flow rate
- B01D 2221/10: Separation devices for use in medical, pharmaceutical or laboratory applications, e.g. separating amalgam from dental treatment residues
- B04B 2005/0471: {with additional elutriation separation of different particles}
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- B01D: SEPARATION (separating solids from solids by wet methods B03B, B03D; by pneumatic jigs or tables B03B; by other dry methods B07; magnetic or electrostatic separation of solid materials from solid materials or fluids, separation by high-voltage electric fields B03C; centrifuges, vortex apparatus B04; presses per se for squeezing-out liquid from liquid-containing material B30B9/02; treatment of water C02F, e.g. softening by ion-exchange C02F1/42; {arrangements of air intake cleaners in gas turbine plants F02C7/05} ; arrangements or mounting of filters in air-conditioning, air-humidification or ventilation F24F13/28)
- B04B: CENTRIFUGES (high-speed drum mills B02C19/11; domestic spin driers D06F; analysing, measuring or monitoring physical or chemical properties of samples during centrifuging, see the relevant subclasses for these procedures, e.g. G01N)

## Abstract

Embodiments are described for separating collecting components from a multi-component fluid such as whole blood. Some embodiments provide for controlling the amount of a component, such as platelets, introduced into a separation chamber to ensure that the density of fluid in the separation chamber does not exceed a particular value. This may provide for collecting purer components. Other embodiments may provide for determining a chamber flow rate based on a concentration of a component in the multi-component fluid, which may then be used to determine a centrifuge speed, to collect purer concentrated components.

## Claims

### Claim 1

A method, comprising:
receiving, by at least one processor, either a first indication of a first collection procedure for collecting a first product from whole blood or a second indication of a second collection procedure for collecting a concentrated product from the whole blood;
when the at least one processor receives the first indication:
receiving, by the at least one processor, first data related to a first amount of a first component in the whole blood from a first source;
rotating a centrifuge at a first centrifuge speed;
introducing the whole blood from the first source into a first separation vessel on the centrifuge at a first flow rate to separate a first composite fluid from the whole blood from the first source;
introducing the first composite fluid, separated from the whole blood from the first source, into a first separation chamber at a first chamber flow rate;
separating the first composite fluid into at least the first component and a second component by subjecting the first composite fluid while in the first separation chamber to a first centrifugal field created by the centrifuge rotating at the first centrifuge speed;
during the separating, maintaining an amount of at least one of the first component of the first composite fluid and the second component of the first composite fluid in the first separation chamber below a predetermined amount;
determining a depletion in the amount of the first component in the whole blood from the first source;
changing, in response to determining the depletion in the amount of the first component in the whole blood from the first source, the first flow rate to introduce the whole blood from the first source into the first separation vessel at a second flow rate; and
collecting the first component of the first composite fluid in a first storage container to form the first product; and
when the at least one processor receives the second indication:
receiving, by the at least one processor, the first data;
determining, by the at least one processor, a second chamber flow rate based on the first data;
determining a second centrifuge speed based on the second chamber flow rate;
rotating the centrifuge at the second centrifuge speed;
introducing the whole blood from the first source into the first separation vessel at a third flow rate to separate a second composite fluid from the whole blood from the first source;
introducing the second composite fluid, separated from the whole blood from the first source, into the first separation chamber at the second chamber flow rate;
separating the second composite fluid into at least the first component and the second component by subjecting the second composite fluid while in the first separation chamber to a second centrifugal field created by the centrifuge rotating at the second centrifuge speed; and
collecting the first component of the second composite fluid in the first storage container to form the concentrated product.

### Claim 2 (depends on 1)

The method of claim 1, wherein the first component of the first composite fluid and the first component of the second composite fluid comprises platelets and the second component of the first composite fluid and the second component of the second composite fluid comprises white blood cells.

### Claim 3 (depends on 2)

The method of claim 2, wherein the first product and the concentrated product comprise less than 1×106 of white blood cells for every 3×1011 platelets.

### Claim 4 (depends on 1)

The method of claim 1, wherein the second flow rate is higher than the first flow rate.

### Claim 5 (depends on 4)

The method of claim 4, wherein the third flow rate is lower than the first flow rate and lower than the second flow rate.

### Claim 6 (depends on 5)

The method of claim 5, wherein the second centrifuge speed is lower than the first centrifuge speed, and wherein the second centrifugal field created by the centrifuge rotating at the second centrifuge speed is lower than the first centrifugal field created by the centrifuge rotating at the first centrifuge speed.

### Claim 7 (depends on 1)

The method of claim 1, wherein, in response to receiving the first indication and prior to rotating the centrifuge at the first centrifuge speed, the method further comprises:
determining, by the at least one processor, the first flow rate to separate the first composite fluid from the whole blood from the first source based on the first data.

### Claim 8 (depends on 7)

The method of claim 7, further comprising:
determining, by the at least one processor, the first centrifuge speed corresponding to an adjustment to a first predetermined speed for rotating the centrifuge based on the first flow rate.

### Claim 9 (depends on 1)

The method of claim 1, wherein determining the depletion in the amount of the first component in the whole blood from the first source comprises:
determining a predetermined period of time after the first composite fluid is introduced into the first separation chamber, that a number of platelets in the whole blood from the first source are depleted.

### Claim 10 (depends on 9)

The method of claim 9, wherein the second flow rate draws the whole blood from the first source at a higher rate than the first flow rate.

### Claim 11

A separation device, comprising:
a centrifuge;
a processor coupled with the centrifuge; and
a memory coupled with and readable by the processor and storing therein instructions that, when executed by the processor, cause the processor to:
receive either a first indication of a first collection procedure for collecting a first product from whole blood or receive a second indication of a second collection procedure for collecting a concentrated product from the whole blood;
when the processor receives the first indication, the instructions, when executed by the processor, cause the processor to:
receive first data related to a first amount of a first component in the whole blood from a first source;
rotate the centrifuge at a first centrifuge speed;
introduce the whole blood from the first source into a first separation vessel on the centrifuge at a first flow rate to separate a first composite fluid from the whole blood from the first source;
introduce the first composite fluid, separated from the whole blood from the first source, into a first separation chamber at a first chamber flow rate;
separate the first composite fluid into at least the first component and a second component by subjecting the first composite fluid while in the first separation chamber to a first centrifugal field created by the centrifuge rotating at the first centrifuge speed;
during the separating, maintain an amount of at least one of the first component of the first composite fluid and the second component of the first composite fluid in the first separation chamber below a predetermined amount;
determine a depletion in the amount of the first component in the whole blood from the first source;
change, in response to determining the depletion in the amount of the first component in the whole blood from the first source, the first flow rate to introduce the whole blood from the first source into the first separation vessel at a second flow rate; and
collect the first component of the first composite fluid in a first storage container to form the first product; and
when the processor receives the second indication, the instructions, when executed by the processor, cause the processor to:
receive the first data;
determine a second chamber flow rate based on the first data;
determine a second centrifuge speed based on the second chamber flow rate;
rotate the centrifuge at the second centrifuge speed;
introduce the whole blood from the first source into the first separation vessel at a third flow rate to separate a second composite fluid from the whole blood from the first source;
introduce the second composite fluid, separated from the whole blood from the first source, into the first separation chamber at the second chamber flow rate;
separate the second composite fluid into at least the first component and the second component by subjecting the second composite fluid while in the first separation chamber to a second centrifugal field created by the centrifuge rotating at the second centrifuge speed; and
collect the first component of the second composite fluid in the first storage container to form the concentrated product.

### Claim 12 (depends on 11)

The separation device of claim 11, further comprising:
a tubing set comprising a tubing circuit disposed between the first source and the centrifuge.

### Claim 13 (depends on 12)

The separation device of claim 12, wherein the whole blood from the first source flows through at least one tubing loop of the tubing set from the first source to the centrifuge.

### Claim 14 (depends on 13)

The separation device of claim 13, wherein the tubing set further comprises a cassette, wherein the first storage container is interconnected to the cassette, and wherein the first component of the first composite fluid flows through the cassette from the first separation chamber to the first storage container.

### Claim 15 (depends on 13)

The separation device of claim 13, wherein the tubing set further comprises a cassette, wherein the first storage container is interconnected to the cassette, and wherein the first component of the second composite fluid flows through the cassette from the first separation chamber to the first storage container.

### Claim 16 (depends on 14)

The separation device of claim 14, further comprising:
at least one pump that introduces the first composite fluid into the first separation chamber at the first chamber flow rate.

### Claim 17 (depends on 16)

The separation device of claim 16, wherein the at least one pump comprises a peristaltic pump that engages with the at least one tubing loop of the tubing set.

### Claim 18

A method, comprising:
receiving, by at least one processor, either a first indication of a first collection procedure for collecting a first product from whole blood or a second indication of a second collection procedure for collecting a concentrated product from the whole blood;
when that least one processor receives the first indication:
receiving, by the at least one processor, first data related to a first amount of a first component in the whole blood;
rotating a centrifuge at a first centrifuge speed;
introducing a first portion of the whole blood into a first separation vessel on the centrifuge at a first flow rate to separate a first composite fluid from the first portion of the whole blood;
introducing the first composite fluid, separated from the first portion of the whole blood, into a first separation chamber at a first chamber flow rate;
separating the first composite fluid into at least the first component and a second component by subjecting the first composite fluid while in the first separation chamber to a first centrifugal field created by the centrifuge rotating at the first centrifuge speed;
during the separating, maintaining an amount of at least one of the first component of the first composite fluid and the second component of the first composite fluid in the first separation chamber below a predetermined amount;
determining a depletion in the amount of the first component of the first composite fluid measured in the first portion of the whole blood;
changing, in response to determining the depletion in the amount of the first component measured in the first portion of the whole blood, the first flow rate to introduce the first portion of the whole blood into the first separation vessel at a second flow rate; and
collecting the first component of the first composite fluid in a first storage container to form the first product; and
when the at least one processor receives the second indication:
receiving, by the at least one processor, the first data;
determining, by the at least one processor, a second chamber flow rate based on the first data;
determining a second centrifuge speed based on the second chamber flow rate;
rotating the centrifuge at the second centrifuge speed;
introducing a second portion of the whole blood into the first separation vessel at a third flow rate to separate a second composite fluid from the second portion of the whole blood;
introducing the second composite fluid, separated from the second portion of the whole blood, into the first separation chamber at the second chamber flow rate;
separating the second composite fluid into at least the first component and the second component by subjecting the second composite fluid while in the first separation chamber to a second centrifugal field created by the centrifuge rotating at the second centrifuge speed; and
collecting the first component of the second composite fluid in the first storage container to form the concentrated product.

### Claim 19 (depends on 18)

The method of claim 18, wherein the first portion of the whole blood and the second portion of the whole blood are received from a first source.

### Claim 20 (depends on 18)

The method of claim 18, wherein the second flow rate is higher than the first flow rate, wherein the second centrifuge speed is lower than the first centrifuge speed, and wherein the second centrifugal field created by the centrifuge rotating at the second centrifuge speed is lower than the first centrifugal field created by the centrifuge rotating at the first centrifuge speed.