System And Method For Collecting Plasma

Patent No. US11738124 (titled "System And Method For Collecting Plasma") was filed by Haemonetics Corp on Sep 13, 2022.

What is this patent about?

’124 is related to the field of blood apheresis, specifically systems and methods for collecting plasma from a donor. Traditional apheresis procedures involve withdrawing whole blood, separating it into components, collecting the desired component (e.g., plasma), and returning the remaining components to the donor. Existing systems often struggle with precisely determining the volume of pure plasma collected due to the presence of anticoagulant, leading to potential under- or over-collection relative to regulatory limits.

The underlying idea behind ’124 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 volume of anticoagulant present in the collected plasma based on the donor's hematocrit and the amount of anticoagulant introduced. By subtracting the calculated anticoagulant volume from the total collected volume, the system can precisely determine the volume of pure plasma.

The claims of ’124 focus on a method and system for collecting plasma that includes determining a donor's weight and hematocrit, withdrawing whole blood and introducing anticoagulant, separating the blood into components, collecting the plasma, calculating the volume of anticoagulant in the collected plasma based on the donor's hematocrit, calculating the volume of pure plasma, and continuing the process until a target volume of pure plasma is collected. The system includes a controller that performs these calculations and controls the blood draw pump.

In practice, the system uses a centrifugal bowl to separate blood components. A controller monitors the amount of anticoagulant added, either by tracking pump rotations or measuring the weight change of the anticoagulant source. The donor's hematocrit, either pre-determined or measured during the process using an optical sensor, is then used to calculate the anticoagulant volume in the collected plasma. This allows for a more accurate determination of the pure plasma volume, ensuring compliance with regulatory limits and maximizing plasma collection.

Unlike prior approaches that rely on total volume (plasma + anticoagulant) for collection, ’124 adjusts for variations in donor hematocrit. This ensures that a consistent volume of pure plasma is collected from each donor, regardless of their hematocrit level. By precisely controlling the collection process based on pure plasma volume, the system can potentially collect a greater volume of plasma compared to prior art systems, while still adhering to regulatory guidelines.

How does this patent fit in bigger picture?

Technical landscape at the time

In the late 2010s when ’124 was filed, apheresis systems were at a time when blood component separation was typically implemented using centrifugal force and when systems commonly relied on controlling fluid flow rates and monitoring volumes to manage the separation and collection of specific blood components. At this time, hardware and software constraints made real-time calculation of component concentrations and precise volume measurements non-trivial, especially in systems aiming to optimize collection within regulatory limits.

Novelty and Inventive Step

The application was rejected in a non-final office action. The claims were rejected for nonstatutory double patenting over a prior patent to the same inventor. The rejection stated that the claims were not patentably distinct from the claims of U.S. Patent No. 10,758,652. The prosecution record does not describe the technical reasoning or specific claim changes that led to allowance.

Claims

This patent contains 20 claims, with independent claims 1 and 11. Independent claim 1 focuses on a method for collecting plasma, while independent claim 11 focuses on a system for collecting plasma. The dependent claims generally elaborate on and add details to the method and system described in the independent claims.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Anticoagulant line
(Claim 1, Claim 11)
“The method may then introduce anticoagulant into the withdrawn whole blood through an anticoagulant line and separate, using the blood component separation device, the withdrawn whole blood into a plasma component and at least a second blood component. The system may also include a blood draw line fluidly connected to the venous-access device and an anticoagulant line connected to an anticoagulant source. The anticoagulant line may introduce anticoagulant into the drawn whole blood.”A line through which anticoagulant is introduced into the withdrawn whole blood.
Blood component separation device
(Claim 1, Claim 11)
“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 11)
“Once separated, the plasma component may be collected from the blood component separation device and into a plasma collection container. 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 container that receives the plasma component from the blood component separation device.
Target volume of pure plasma
(Claim 1, Claim 11)
“The method may continue the process (e.g., withdrawing whole blood, introducing anticoagulant into the whole blood, separating the blood, collecting the plasma, and calculating the percentage of anticoagulant and volume of pure plasma) until a target volume of pure plasma is collected within the plasma collection container. 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 predetermined volume of pure plasma to be collected in the plasma collection container.
Volume of pure plasma
(Claim 1, Claim 11)
“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. The volume of pure plasma may be based, at least in part, on the calculated percentage of anticoagulant in the collected plasma component. The method may continue the process (e.g., withdrawing whole blood, introducing anticoagulant into the whole blood, separating the blood, collecting the plasma, and calculating the percentage of anticoagulant and volume of pure plasma) until a target volume of pure plasma is collected within the plasma collection container.”The volume of plasma in the plasma collection container, excluding the volume of anticoagulant.

Litigation Cases New

US Latest litigation cases involving this patent.

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

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US11738124

HAEMONETICS CORP
Application Number
US17943410
Filing Date
Sep 13, 2022
Status
Granted
Expiry Date
May 30, 2037
External Links
Slate, USPTO, Google Patents