US 10792416

Patent Summary: US 10,792,416 B2

Title: System and method for collecting plasma

Assignee: Haemonetics Corp

Inventor: Michael Ragusa

Filing Date: October 25, 2017

Issue Date: October 6, 2020

Abstract:
A method for collecting plasma includes determining the weight, height, and hematocrit of a donor, and calculating a donor plasma volume and a target plasma collection volume. The target plasma collection volume is based on the donor plasma volume and a target percentage of plasma. The method then withdraws blood from the donor through a line connected to a blood component separation device, and introduces anticoagulant into the withdrawn blood. The blood component separation device separates the blood into a plasma component and a second blood component, and the plasma component is collected from the blood component separation device and into a plasma collection container. The method may then calculate the volume of pure plasma collected within the plasma collection container, and continue processing/collecting until the calculated volume of pure plasma equals the target plasma collection volume.

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Plain-Language Overview of Independent Claims:

This patent has three independent claims: Claim 1 (a method), Claim 11 (a system), and Claim 18 (a method).

Claim 1 (Method for Collecting Plasma):
This claim describes a process for collecting plasma from a donor that is personalized to that individual. The core steps are:

1. Determine Donor Information: The process starts by measuring the donor's weight and hematocrit (the proportion of red blood cells in their blood).
2. Venous Access: A needle or similar device is inserted into the donor's vein.
3. Blood Withdrawal and Separation: Whole blood is drawn from the donor, mixed with an anticoagulant to prevent clotting, and then separated into plasma and other blood components (like red blood cells) using a separation device.
4. Plasma Collection: The separated plasma component is collected into a container.
5. Calculate "Pure" Plasma Volume: Crucially, the system calculates the actual volume of plasma collected, excluding the volume of the anticoagulant that was mixed in. This is done by first calculating the percentage of anticoagulant in the collected fluid.
6. Stop at Target: The collection process continues until a predetermined target volume of pure plasma is reached. This target is based on the donor's weight.

In essence, this method aims to collect a more accurate and standardized amount of plasma from each donor by accounting for the variable amount of anticoagulant in the final collected product.

Claim 11 (System for Collecting Plasma):
This claim describes the physical equipment or "system" that performs the method of Claim 1. The key components of the system are:

1. Blood Access and Separation Devices: A venous-access device (like a needle) and a blood component separation device (like a centrifuge).
2. Tubing and Pumps: A blood draw line to transport blood to the separator and an anticoagulant line to add anticoagulant. A pump controls the flow of blood.
3. A "Smart" Controller: A controller (a computer) is the brain of the system. It is programmed to:
   • Calculate the percentage of anticoagulant in the plasma being collected.
   • Based on that percentage, calculate the volume of pure plasma that has been collected.
   • Stop the blood draw pump automatically when the calculated pure plasma volume reaches a specific target volume, which is determined by the donor's weight.

This system automates the process of collecting a precise, weight-based target volume of pure plasma, removing the guesswork associated with the added anticoagulant.

Claim 18 (A More Personalized Method for Collecting Plasma):
This claim describes a more advanced and personalized method for plasma collection. The key steps are:

1. Gather More Donor Data: This method starts by determining the donor's weight, height, and hematocrit.
2. Calculate Total Plasma Volume: The system uses this data to calculate the donor's total plasma volume in their body.
3. Set a Personalized Target: A target collection volume is then calculated, not just based on weight, but as a specific percentage (e.g., between 26.5% and 29.5%) of the donor's total calculated plasma volume.
4. Collect and Calculate: Blood is withdrawn, mixed with anticoagulant, and separated. The plasma component is collected.
5. Monitor "Pure" Plasma: The system calculates the volume of pure plasma collected, excluding the anticoagulant.
6. Stop When Personalized Target is Met: The process continues until the volume of pure plasma collected equals the personalized target volume.
7. Manage Fluid Balance: After collection, the system may return the other blood components (like red blood cells) and a specific volume of saline to the donor to manage their fluid levels (intravascular deficit) and reduce the risk of adverse reactions like fainting.

This method represents a highly individualized approach, aiming to collect a consistent percentage of each donor's available plasma and actively managing the donor's physiological state post-donation.

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Disclaimer: This summary is based on the provided patent text. I have not conducted a separate search of CAFC dockets for 2026, and the provided search results did not contain this information. An Inter Partes Review (IPR2025-01420) has been filed against this patent, indicating a challenge to its validity, but the outcome is not specified in the provided information.