# US 10,946,131 B2 · Systems and methods for optimization of plasma collection volumes

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- Number: US 10,946,131 B2
- Document ID: US10946131B2
- Status: Granted
- Kind: B2
- Application number: 17/062,368
- Filed: 2020-10-02
- Published: 2021-01-21
- Granted: 2021-03-16
- Earliest claimed: 2018-05-21
- Assignees: Fenwal, Inc.
- Applicants: Fenwal, Inc.
- Inventors: Amit J. Patel; Samantha M. Planas; Walter T. Watts; Kyungyoon Min; Daniel R. Boggs
- Web page: https://patentgrep.com/patent/US10946131B2

## CPC

- A61M 1/3496: {Plasmapheresis; Leucopheresis; Lymphopheresis (A61M1/3472 takes precedence)}
- A61M 1/34: Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- A61M 1/3403: {Regulation parameters}
- A61M 1/3607: {Regulation parameters}
- A61M 1/3609: {Physical characteristics of the blood, e.g. haematocrit, urea}
- A61M 1/3616: {Batch-type treatment}
- A61M 1/362262: {Details of incorporated reservoirs}
- A61M 1/362266: {Means for adding solutions or substances to the blood}
- A61M 1/3643: {Priming, rinsing before or after use}
- A61M 1/3672: {Means preventing coagulation}
- A61M 1/38: Removing constituents from donor blood and {storing or} returning remainder to body {, e.g. for transfusion}
- A61M 1/382: {Optimisation of blood component yield}
- A61M 1/385: {taking into account of the patient characteristics}
- G01N 33/48: Biological material, e.g. blood, urine (G01N33/02, G01N33/26, G01N33/44, G01N33/46 take precedence); Haemocytometers (counting blood corpuscules distributed over a surface by scanning the surface G06M11/02)
- G16H 10/60: for patient-specific data, e.g. for electronic patient records
- G16H 40/60: for the operation of medical equipment or devices
- A61M 2202/0415: Plasma
- A61M 2205/33: Controlling, regulating or measuring
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3379: Masses, volumes, levels of fluids in reservoirs, flow rates
- A61M 2205/3393: by weighing the reservoir
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
- A61M 2230/207: hematocrit
- 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)}
- 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)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A plasmapheresis system and a method for operating a plasmapheresis system are provided by which the volume/weight of anticoagulated plasma that is collected is optimized. In one example, a nomogram is provided that utilizes the donor's hematocrit to calculate the volume/weight of raw plasma within a plasma product having the maximum volume permitted by the FDA nomogram. In a plasmapheresis procedure having multiple collection phases followed by a reinfusion cycle in which concentrated red blood cells are returned to the donor, the volume of plasma product to be collected is calculated prior to the start of each collection cycle to account for the donor's increasing hematocrit, thus resulting in a greater total volume of plasma product to be collected during the plasmapheresis procedure.

## Claims

### Claim 1

A system for collecting plasma, comprising:
a venipuncture needle configured to draw whole blood from a donor;
a blood separator configured to separate the whole blood into a plasma product and a second blood component comprising red blood cells, the blood separator having a plasma output port coupled to a plasma line configured to send the plasma product to a plasma product collection container;
a donor line fluidly coupled to the venipuncture needle configured to introduce the whole blood from the donor to the blood separator, flow through the donor line being controlled by a first pump;
an anticoagulant line coupled to an anticoagulant source, the anticoagulant line configured to combine anticoagulant with the whole blood from the donor, flow through the anticoagulant line being controlled by a second pump;
a touchscreen configured to receive input from an operator; and
a controller programmed to control operation of the system, the controller coupled to the touchscreen and programmed to receive at least a donor's weight and hematocrit, to determine a target volume for plasma product and/or raw plasma, to control the system to operate a draw and return cycle to withdraw the whole blood from the donor and separate the whole blood into the plasma product and the second blood component and to return the second blood component to the donor, to establish a current value of the hematocrit of the donor and a new target volume for plasma product and/or raw plasma, and to control the system to operate a subsequent draw and return cycle, whereby the donor's changing hematocrit is taken into account in calculating the new target volume for plasma product and/or raw plasma, wherein the controller is further programmed to determine the target volume for plasma product (VPP) based on the target volume for raw plasma (VRP), the hematocrit (Hct) and an anticoagulant ratio (ACR) such that: VPP=VRP*K, wherein K=(ACR*(1−Hct/100)+1)/(ACR*(1−Hct/100)).

### Claim 2 (depends on 1)

The system of claim 1, wherein the controller is programmed to determine the target volume for plasma product and/or raw plasma before a start of a first draw and return cycle.

### Claim 3 (depends on 2)

The system of claim 2, wherein the controller is programmed to repeat draw and return phases until the target volume of plasma product and/or raw plasma is collected, wherein the target volume for plasma product and/or raw plasma is redetermined prior to the start of each draw phase.

### Claim 4 (depends on 3)

The system of claim 3, wherein the controller is programmed to perform the draw and return phases at least three times.

### Claim 5 (depends on 1)

The system of claim 1, wherein the controller is programmed to determine the target volume for plasma product and/or raw plasma based on the donor's total blood volume and the donor's plasma volume.

### Claim 6 (depends on 1)

The system of claim 1, wherein the controller is programmed to initiate a final return of the second blood component when (1) a measured volume of plasma product in the plasma collection container reaches the target volume for plasma product and/or (2) a volume of raw plasma in the plasma collection container reaches the target volume for raw plasma.

### Claim 7

A system for collecting plasma, comprising:
a venipuncture needle configured to draw whole blood from a donor;
a blood separator configured to separate the whole blood into a plasma product and a second blood component comprising red blood cells, the blood separator having a plasma output port coupled to a plasma line configured to send the plasma product to a plasma product collection container;
a donor line fluidly coupled to the venipuncture needle configured to introduce the whole blood from the donor to the blood separator, flow through the donor line being controlled by a first pump;
an anticoagulant line coupled to an anticoagulant source, the anticoagulant line configured to combine anticoagulant with the whole blood from the donor, flow through the anticoagulant line being controlled by a second pump;
a touchscreen configured to receive input from an operator; and
a controller programmed to control operation of the system, the controller coupled to the touchscreen and programmed to receive at least a donor's weight, height, sex and hematocrit, to determine a target volume for plasma product and/or raw plasma based at least in part on the weight, height and hematocrit, to control the system to operate draw and return phases to withdraw whole blood from the donor and separate the whole blood into the plasma product and the second blood component and to return the second blood component to the donor, wherein the controller is further programmed to determine the target volume for plasma product (VPP) based on the target volume for raw plasma (VRP), the hematocrit (Hct) and an anticoagulant ratio (ACR) such that: VPP=VRP*K, wherein K=(ACR*(1−Hct/100)+1)/(ACR*(1−Hct/100)).

### Claim 8 (depends on 7)

The system of claim 7, wherein the controller is further programmed to account for anticoagulant introduced into the plasma collection container separately from the plasma product.

### Claim 9 (depends on 8)

The system of claim 8, wherein the controller is further programmed to account for anticoagulant introduced into the plasma collection container separate from the plasma product attributable to a priming or other pre-processing step.

### Claim 10

A system for collecting plasma, comprising:
a venipuncture needle configured to draw whole blood from a donor;
a blood separator configured to separate the whole blood into a plasma product and a second blood component comprising red blood cells, the blood separator having a plasma output port coupled to a plasma line configured to send the plasma product to a plasma product collection container;
a donor line fluidly coupled to the venipuncture needle configured to introduce the whole blood from the donor to the blood separator, flow through the donor line being controlled by a first pump;
an anticoagulant line coupled to an anticoagulant source, the anticoagulant line configured to combine anticoagulant with the whole blood from the donor, flow through the anticoagulant line being controlled by a second pump;
a touchscreen configured to receive input from an operator; and
a controller programmed to control operation of the system, the controller coupled to the touchscreen and programmed to receive at least a donor's weight, height and hematocrit and to determine a target volume for plasma product comprising raw plasma and anticoagulant, wherein the target volume for plasma product is determined prior to withdrawing the whole blood from the donor based at least in part on an anticoagulant ratio, the donor's weight, height and the donor's hematocrit, the controller programmed to then control the system to operate a plurality of draw and return cycles to withdraw whole blood from the donor and separate the whole blood into the plasma product and the second blood component and to return the second blood component to the donor, wherein the controller is further programmed to determine the target volume for plasma product (VPP) based on the target volume for raw plasma (VRP), the hematocrit (Hct) and an anticoagulant ratio (ACR) such that: VPP=VRP*K, wherein K=(ACR*(1−Hct/100)+1)/(ACR*(1−Hct/100)).

### Claim 11 (depends on 10)

The system of claim 10, wherein the controller is programmed to determine the target volume for plasma product based on the donor's total blood volume and the donor's plasma volume.

### Claim 12 (depends on 11)

The system of claim 11, wherein the controller is programmed to determine the donor's total blood volume based on multiple parameters selected from the group consisting of the weight, height, sex, age, and morphology of the donor.

### Claim 13 (depends on 10)

The system of claim 10, wherein the controller is configured to receive the donor's weight and hematocrit electronically from a donor management system.

### Claim 14 (depends on 10)

The system of claim 10, wherein the controller is programmed to control the system to collect the plasma product in the plasma product collection container until the plasma product in the plasma product collection container reaches the determined target volume.

### Claim 15 (depends on 10)

The system of claim 10, wherein the controller is programmed to perform the draw and return cycles at least three times and the controller is programmed to determine a volume of whole blood to be drawn in a final draw phase which is different than a volume drawn in a prior draw phase.

### Claim 16 (depends on 10)

The system of claim 10, wherein the controller is further programmed to determine a volume of interstitial fluid that shifts based on a volume of plasma collected and determine a changed hematocrit of the donor based on the shifted volume of interstitial fluid.

### Claim 17

A system for collecting plasma, comprising:
a venipuncture needle configured to draw whole blood from a donor;
a blood separator configured to separate the whole blood into a plasma product and a second blood component comprising red blood cells, the blood separator having a plasma output port coupled to a plasma line configured to send the plasma product to a plasma product collection container;
a donor line fluidly coupled to the venipuncture needle configured to introduce the whole blood from the donor to the separator, flow through the donor line being controlled by a first pump;
an anticoagulant line coupled to an anticoagulant source, the anticoagulant line configured to combine anticoagulant with the whole blood from the donor, flow through the anticoagulant line being controlled by a second pump;
a touchscreen configured to receive input from an operator; and
a controller programmed to control operation of the system, the controller coupled to the touchscreen and programmed to receive donor parameters electronically from a donor management system, to determine a target volume for plasma product and/or raw plasma based at least in part on the donor parameters and to control the system to operate draw and return phases to withdraw whole blood from a donor and separate the whole blood into the plasma product and the second blood component and to return the second blood component to the donor, wherein the controller is further programmed to determine the target volume for plasma product (VPP) based on the target volume for raw plasma (VRP), the hematocrit (Hct) and an anticoagulant ratio (ACR) such that: VPP=VRP*K, wherein K=(ACR*(1−Hct/100)+1)/(ACR*(1−Hct/100)).

### Claim 18 (depends on 17)

The system of claim 17, wherein the controller is programmed to control the system to collect the plasma product in the plasma product collection container until a collected volume of plasma product reaches the target volume for plasma product and/or raw plasma.

### Claim 19 (depends on 17)

The system of claim 17, further comprising the donor management system, wherein the donor management system is in electronic communication with the controller.

### Claim 20 (depends on 19)

The system of claim 19, wherein the donor management system is programmed to calculate the target volume for plasma product and/or raw plasma and the controller is programmed to determine a target volume for plasma product and/or raw plasma by receiving the target volume for plasma product and/or raw plasma from the donor management system.

### Claim 21 (depends on 17)

The system of claim 17, wherein the controller determines the target volume for plasma product and/or raw plasma by calculating the target volume for plasma product and/or raw plasma and wherein the controller is local to and coupled to the blood separator.

### Claim 22 (depends on 17)

The system of claim 17, wherein the donor parameters received electronically from the donor management system comprise a donor weight, wherein the controller is programmed to determine the target volume for plasma product and/or raw plasma based at least in part on the donor weight.

### Claim 23 (depends on 22)

The system of claim 22, wherein the donor parameters received electronically from the donor management system comprise a donor hematocrit, wherein the controller is programmed to determine the target volume for plasma product and/or raw plasma based at least in part on the donor hematocrit.

### Claim 24 (depends on 23)

The system of claim 23, wherein the controller is programmed to determine a target volume for plasma product based on the donor's total blood volume and the donor's plasma volume.

### Claim 25 (depends on 24)

The system of claim 24, wherein the controller is programmed to determine the donor's total blood volume based on the weight and height of the donor.

### Claim 26 (depends on 25)

The system of claim 25, wherein the controller is programmed to determine the donor's total blood volume before whole blood is withdrawn from the donor during a donation.

### Claim 27 (depends on 26)

The system of claim 26, wherein the controller is programmed to determine the target volume for plasma product comprising raw plasma and anticoagulant, wherein the target volume for plasma product is determined prior to withdrawing the whole blood from the donor based at least in part on an anticoagulant ratio, the donor's weight and the donor's hematocrit.

### Claim 28 (depends on 17)

The system of claim 17, further comprising a reservoir separate from the blood separator for receiving concentrated red blood cells.