Plasmapheresis Collection Volume Control Using Donor Hematocrit
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Solution Overview
Problem
Existing plasmapheresis devices inefficiently collect plasma due to the exclusion of donor hematocrit in determining collection volume, leading to suboptimal plasma collection, which can be improved by considering donor-specific factors like hematocrit, weight, height, sex, and age to maximize plasma volume within safety and comfort limits.
Innovation Solution
A modified nomogram that accounts for donor hematocrit to calculate the maximum allowable plasma volume, adjusting the target volume based on hematocrit changes during the procedure, and an automated system with a programmable controller to optimize plasma collection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If the FDA nomogram is used to determine plasma collection volume based only on donor weight, then the procedure is simple and consistent, but the plasma collection efficiency is reduced because donor hematocrit is excluded
Solution Approach 1:
The patent modifies the collection volume determination by changing from a single parameter (weight-only FDA nomogram) to multiple parameters including weight, height, sex, age, and hematocrit. This allows the system to calculate a more accurate maximum plasma volume specific to each donor, thereby improving collection efficiency without excessive complexity
Solution Approach 2:
The system dynamically adjusts the target plasma collection volume based on real-time donor characteristics. By incorporating hematocrit measurements and demographic factors, the collection volume is optimized for each individual donor rather than using a fixed nomogram approach, improving productivity while managing complexity through automation
2Reliability
If the plasma collection volume is limited according to the FDA nomogram, then donor safety and comfort are ensured, but the maximum safe plasma volume may not be collected due to ignoring hematocrit variations
Solution Approach 1:
The patent introduces hematocrit as an additional parameter to the collection volume calculation. By measuring donor hematocrit and incorporating it into the volume determination algorithm, the system can identify donors who can safely tolerate higher plasma collections, thus increasing the quantity of plasma collected while maintaining safety standards
Solution Approach 2:
The system performs preliminary measurements of donor hematocrit, weight, height, sex, and age before determining the collection volume. This preliminary assessment allows the system to calculate an optimized maximum plasma volume that is both safe for the specific donor and maximizes the quantity of plasma that can be collected
3Quantity of substance
If multiple collection cycles are performed to maximize plasma volume, then the total plasma yield increases, but the procedure time and donor exposure to the process increase
Solution Approach 1:
The system calculates the optimized target plasma volume before the collection procedure begins, based on comprehensive donor assessment including hematocrit, weight, height, sex, and age. This preliminary optimization allows the maximum safe plasma to be collected in fewer cycles, reducing procedure time while maximizing the total plasma volume obtained
Solution Approach 2:
The system uses real-time monitoring and calculation during the collection process, adjusting based on actual plasma volume obtained and donor response. This feedback mechanism ensures that the optimized collection target is achieved efficiently, minimizing unnecessary cycles and reducing overall procedure time
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system ensures the collection of the maximum safe plasma volume by dynamically adjusting the target volume based on hematocrit changes, thereby increasing the overall efficiency of plasma collection.
Implementation Method 1
The separation of the plasma from the cellular components is typically accomplished in an automated procedure by centrifugation or membrane filtration
Implementation Method 2
The separation of the plasma from the cellular components is typically accomplished in an automated procedure by centrifugation or membrane filtration
Data Source
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AI summary
A plasmapheresis system and a method for operating a plasmapheresis system are provided by which the volume/weight of anticoagulated plasma that is collected is optimized. In one example, a nomogram is provided that utilizes the donor's hematocrit to calculate the volume/weight of raw plasma within a plasma product having the maximum volume permitted by the FDA nomogram. In a plasmapheresis procedure having multiple collection phases followed by a reinfusion cycle in which concentrated red blood cells are returned to the donor, the volume of plasma product to be collected is calculated prior to the start of each collection cycle to account for the donor's increasing hematocrit, thus resulting in a greater total volume of plasma product to be collected during the plasmapheresis procedure.