System And Method For Collecting Plasma
Patent No. US12186474 (titled "System And Method For Collecting Plasma") was filed by Haemonetics Corp on Mar 18, 2021.
What is this patent about?
’474 is related to the field of blood apheresis , specifically systems and methods for collecting plasma from a donor. The background acknowledges that regulations limit the amount of plasma that can be collected. Prior systems collect based on total volume (plasma and anticoagulant), not the actual plasma volume, and don't tailor collection to the individual donor's specific characteristics, leading to inconsistent plasma collection percentages.
The underlying idea behind ’474 is to precisely control plasma collection by calculating a target plasma collection volume based on the donor's individual characteristics, such as weight, height, sex, and hematocrit. This allows for a more consistent and personalized approach to plasma collection, ensuring that a desired percentage of the donor's plasma is collected, rather than relying on generic weight-based limits.
The claims of ’474 focus on a system for collecting plasma that includes a venipuncture needle, a blood separator, donor and anticoagulant lines with pumps, a touchscreen for operator input, and a controller. The controller is programmed to receive donor parameters (weight, height, sex, hematocrit), determine a target plasma volume based on the donor's total blood volume or plasma volume, and control the system to perform draw and return cycles.
The system operates by withdrawing whole blood from the donor, mixing it with anticoagulant, separating the blood into plasma and red blood cells, collecting the plasma, and returning the red blood cells to the donor. The controller uses the donor's parameters to calculate the target plasma volume before or during the procedure. In some embodiments, the controller dynamically adjusts the target volume based on changes in the donor's hematocrit during the process, ensuring accurate plasma collection even as the donor's blood composition changes.
This approach differs from prior art systems by actively calculating and adjusting the target plasma volume based on individual donor characteristics and real-time hematocrit measurements. This allows for a more precise and consistent collection of plasma, optimizing the process for both donor safety and plasma yield. By tailoring the collection to the individual, the system can avoid over- or under-collecting plasma, which can occur with simpler weight-based methods.
How does this patent fit in bigger picture?
Technical landscape at the time
In the late 2010s when ’474 was filed, apheresis systems commonly relied on centrifugal separation to isolate plasma from whole blood at a time when calculating the precise volume of collected plasma, accounting for anticoagulant, was non-trivial. At that time, systems typically relied on pre-calculated estimates rather than real-time measurements to manage the collection process.
Novelty and Inventive Step
The patent was approved because the prior art did not disclose or suggest a method for collecting blood plasma where the volume of anticoagulant in the collected plasma component is calculated in real time as the plasma is being collected. The real-time calculation can be performed by, for example, counting anticoagulant pump revolutions. Prior art systems relied on calculations prepared in advance.
Claims
This patent contains 26 claims, with independent claims 1, 6, 9, and 15. The independent claims are directed to systems for collecting plasma from a donor, involving a venipuncture needle, a blood separator, donor and anticoagulant lines with pumps, a touchscreen, and a controller programmed to determine target plasma volume based on donor parameters and control draw and return cycles. The dependent claims generally elaborate on the specifics of the controller's programming, the parameters used for volume determination, and additional system components.
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Date
Description
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US12186474
- Application Number
- US17205400
- Filing Date
- Mar 18, 2021
- Status
- Granted
- Expiry Date
- Jan 21, 2040
- External Links
- Slate, USPTO, Google Patents