Patent No. US10980934 (titled "System And Method For Collecting Plasma") was filed by Haemonetics Corp on Jul 16, 2020.
’934 is related to the field of apheresis , specifically systems and methods for collecting plasma from a donor. Apheresis involves separating blood components, collecting the desired component (in this case, plasma), and returning the remaining components to the donor. Regulations limit the amount of blood components that can be removed, and prior systems struggle to accurately determine the volume of pure plasma collected, often relying on total collection volume (including anticoagulant) and not tailoring collection to the individual donor's characteristics.
The underlying idea behind ’934 is to precisely control plasma collection by calculating a target plasma volume based on the donor's individual characteristics. This involves determining the donor's weight, height, and hematocrit to estimate their plasma volume. Then, a target percentage of this plasma volume is calculated, and the system aims to collect only that amount of pure plasma, excluding the volume of anticoagulant added during the process.
The claims of ’934 focus on a method and system for collecting plasma that includes determining a donor's weight, height, and hematocrit, calculating a donor plasma volume based on these factors, and then calculating a target plasma volume to collect based on the calculated donor plasma volume and a target percentage of plasma. The system withdraws blood, introduces anticoagulant, separates the blood into components, collects the plasma, and continues until the target plasma volume is reached.
In practice, the system uses a blood component separation device, such as a centrifuge, to separate plasma from other blood components. A controller manages the pumps and valves to withdraw blood, introduce anticoagulant, and collect plasma. The system calculates the donor's plasma volume using their weight, height, and hematocrit. It then determines the target plasma volume to collect as a percentage of the donor's total plasma volume. The system monitors the collected plasma and stops the process when the target volume is reached, ensuring a consistent percentage of plasma is collected from each donor.
’934 differentiates itself from prior approaches by tailoring the plasma collection volume to the individual donor's characteristics, rather than relying on generic weight-based guidelines. By calculating the donor's plasma volume and collecting a specific percentage, the system ensures a more consistent and controlled collection process. Furthermore, the system can calculate and compensate for the intravascular deficit by returning saline to the donor, minimizing the risk of adverse reactions like fainting. This personalized approach optimizes plasma collection while prioritizing donor safety and well-being.
In the late 2010s when '934 was filed, apheresis systems commonly relied on centrifugal separation techniques to isolate plasma from whole blood at a time when calculating precise plasma volumes during collection was non-trivial. At that time, systems typically relied on monitoring total collection volume rather than directly calculating the pure plasma volume due to hardware or software constraints.
The application was subject to a non-final office action. Claims 1-3, 8-17, and 23-30 were rejected for nonstatutory double patenting over a prior patent. Claims 8-14 and 23-30 were rejected under 35 U.S.C. 102 as being anticipated by a prior art reference. Claims 1-7 and 15-22 were rejected under 35 U.S.C. 103 as being unpatentable over a combination of prior art references. The prosecution record does not describe the technical reasoning or specific claim changes that led to allowance.
This patent contains 30 claims, with independent claims 1, 8, 15, 23, and 26. The independent claims focus on methods and systems for collecting plasma from a donor, including calculating plasma volumes and controlling blood processing devices. The dependent claims generally elaborate on the calculations, system configurations, and control parameters described in the independent claims.
Definitions of key terms used in the patent claims.
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