System And Method For Collecting Plasma

Patent No. US10980926 (titled "System And Method For Collecting Plasma") was filed by Haemonetics Corp on May 4, 2020.

What is this patent about?

’926 is related to the field of blood apheresis, specifically systems and methods for collecting plasma from a donor. Apheresis involves withdrawing blood, separating it into components, collecting the desired component (e.g., plasma), and returning the remaining components to the donor. Regulations limit the amount of blood components that can be removed, creating a need for precise collection methods.

The underlying idea behind ’926 is to accurately determine the pure plasma volume collected during apheresis by accounting for the anticoagulant mixed with the plasma. This is achieved by calculating the percentage of anticoagulant in the collected plasma based on the donor's hematocrit and the amount of anticoagulant introduced. By calculating the volume of pure plasma, the system can collect the maximum allowable plasma volume without exceeding regulatory limits.

The claims of ’926 focus on a method and system for collecting plasma that includes determining the donor's weight and hematocrit, calculating the volume of anticoagulant to be collected with the plasma, calculating a target volume of pure plasma based on the donor's weight, and determining a target collection volume based on the calculated volume of anticoagulant and the calculated volume of pure plasma. The system then withdraws blood, introduces anticoagulant, separates the blood, collects the plasma, and continues until the target collection volume is reached.

In practice, the system uses a blood component separation device , such as a centrifuge, to separate the blood into plasma and other components. Anticoagulant is introduced into the withdrawn blood at a predetermined ratio. The system monitors the amount of anticoagulant added, either by tracking pump rotations or measuring the weight change of the anticoagulant source. The donor's hematocrit is either pre-determined or measured during the process, potentially using an optical sensor to monitor red blood cell volume within the separation device.

This approach differs from prior art systems that simply collect a fixed total volume of plasma and anticoagulant. Because the percentage of anticoagulant in the collected mixture varies depending on the donor's hematocrit, prior systems could not consistently collect the maximum allowable volume of pure plasma. By calculating the pure plasma volume, ’926 enables the collection of a standardized volume of pure plasma from each donor, maximizing plasma yield while adhering to regulatory constraints.

How does this patent fit in bigger picture?

Technical landscape at the time

In the late 2010s when ’926 was filed, apheresis systems commonly relied on centrifugal separation techniques to isolate blood components, at a time when calculating and controlling the precise volume of collected plasma, especially in relation to anticoagulant levels, was typically implemented using weight sensors and pump controls, when hardware or software constraints made real-time monitoring and adjustment of anticoagulant ratios non-trivial.

Novelty and Inventive Step

The application was a continuation of a prior application. Claims were rejected for double patenting and anticipation/obviousness over prior art. Specifically, claims 1-3, 8-17, and 23-30 were rejected. The prosecution record does not describe the technical reasoning or specific claim changes that led to allowance.

Claims

This patent contains 30 claims, of which claims 1, 8, 15, 23, and 26 are independent. The independent claims are generally directed to methods and systems for collecting plasma, including calculating volumes of anticoagulant and plasma based on donor characteristics, and programming/controlling blood processing devices. The dependent claims generally add specific details or limitations to the broader concepts defined in the independent claims.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Blood component separation device
(Claim 1, Claim 8, Claim 23)
“In accordance with additional embodiments, a system for collecting plasma includes a venous-access device for drawing whole blood from a subject and returning blood components to the subject, and a blood component separation device for separating the drawn blood into a plasma component and a second blood component. The blood component separation device has an outlet and is configured to send the plasma component to a plasma container.”A device that separates whole blood into a plasma component and at least a second blood component.
Plasma collection container
(Claim 1, Claim 15)
“Once separated, the plasma component may be collected from the blood component separation device and into a plasma collection container. During processing, the method may calculate (1) a percentage of anticoagulant in the collected plasma component, and (2) a volume of pure plasma collected within the plasma collection container.”A container for collecting the plasma component after it has been separated from the whole blood.
Target collection volume
(Claim 1, Claim 8, Claim 15, Claim 26)
“The controller configured to calculate (1) a volume of anticoagulant to be collected with plasma component in the plasma container, the volume of anticoagulant to be collected with the plasma component based, at least in part on the hematocrit of the donor, (2) a target volume of pure plasma to collect in the plasma container based, at least in part, on the weight of the donor, and (3) a target collection volume based, at least in part, on the calculated volume of anticoagulant and the calculated volume of pure plasma, the system configured to stop the blood draw pump when the target collection volume is collected within the plasma container.”A calculated volume representing the total amount of fluid (plasma and anticoagulant) to be collected, based on the calculated volume of anticoagulant and the calculated volume of pure plasma.
Target volume of pure plasma
(Claim 1, Claim 8, Claim 15, Claim 23, Claim 26)
“The controller may also calculate (1) a percentage of anticoagulant in the collected plasma component, and (2) a volume of pure plasma collected within the plasma container. The volume of pure plasma may be based, at least in part, upon the percentage of anticoagulant in the collected plasma component. The controller may stop the blood draw pump when a target volume of pure plasma (e.g., based, at least in part, on the weight of the donor) is collected within the plasma container.”A calculated volume of plasma to be collected, excluding anticoagulant, based at least in part on the weight of the donor.
Venous-access device
(Claim 1, Claim 8, Claim 23)
“In accordance with additional embodiments, a system for collecting plasma includes a venous-access device for drawing whole blood from a subject and returning blood components to the subject, and a blood component separation device for separating the drawn blood into a plasma component and a second blood component.”A device for drawing whole blood from a donor and returning blood components to the donor.

Litigation Cases New

US Latest litigation cases involving this patent.

Case NumberFiling DateTitle
1:25-cv-01409May 5, 2025Haemonetics Corporation V. Terumo Bct, Inc.

Patent Family

Patent Family

File Wrapper

The dossier documents provide a comprehensive record of the patent's prosecution history - including filings, correspondence, and decisions made by patent offices - and are crucial for understanding the patent's legal journey and any challenges it may have faced during examination.

  • Date

    Description

  • Get instant alerts for new documents

US10980926

HAEMONETICS CORP
Application Number
US16866078
Filing Date
May 4, 2020
Status
Granted
Expiry Date
May 30, 2037
External Links
Slate, USPTO, Google Patents