# US 11,110,216 B2 · Systems and methods for optimization of plasma collection volumes

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- Number: US 11,110,216 B2
- Document ID: US11110216B2
- Status: Granted
- Kind: B2
- Application number: 17/041,701
- Filed: 2019-05-21
- Published: 2021-01-14
- Granted: 2021-09-07
- 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/US11110216B2

## 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 for drawing whole blood from a donor;
a blood separator for separating the whole blood into a plasma product and a second blood component comprising red blood cells, the blood separator having a plasma output port connected to a plasma line for sending the plasma product component to a plasma product collection container;
a donor line fluidly connected to the venipuncture needle for introducing the whole blood from the donor to the separator and for returning concentrated red blood cells to the donor, flow through the donor line being controlled by a first pump;
an anticoagulant line connected to an anticoagulant source, the anticoagulant line configured to introduce anticoagulant into the donor line; and
a controller configured to control the operation of the blood component separation device and the first pump, the controller configured to calculate a target donor raw plasma volume (VRP) to be collected prior to an initial draw phase and/or a target plasma product volume (VPP) to be collected based, at least in part, on a weight, height and sex of the donor and a hematocrit (Hct) of the donor and the volume of anticoagulant to be added to the target donor raw plasma volume based on an anticoagulant ratio (ACR) and the hematocrit (Hct) of the donor, wherein the controller is further programmed to determine the target plasma product volume (VPP) based on the target donor raw plasma volume (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 further configured to operate the system to perform a plurality of draw phases, to determine the hematocrit of the donor prior to each draw phase, and to recalculate the target plasma product volume based thereon.

### Claim 3 (depends on 1)

The system of claim 1 wherein the controller is further configured to initiate a final return of the second blood component when a measured volume of plasma product in the plasma collection container equals the target plasma product volume.

### Claim 4 (depends on 1)

The system of claim 1 wherein the controller is further configured to account for anticoagulant introduced into the plasma collection container separately from the plasma product.

### Claim 5 (depends on 1)

The system of claim 1 wherein the controller is further configured to account for anticoagulant introduced into the plasma collection container separate from the plasma product attributable to a priming or other pre-processing step.