Tortuous Path Plasma Filtration for Transfusion-Ready Reconstitution
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Solution Overview
Problem
Current methods for producing transfusion-ready plasma are hindered by the presence of microscopic, needle-like fibers that can pass through standard filters, rendering reconstituted plasma not suitable for immediate transfusion, particularly in settings lacking freezers or thawing facilities.
Innovation Solution
A tortuous path filter comprising multiple layers of fibers, beads, or single-layer filters without pores larger than 100 microns along a straight path, designed to trap and remove these fibers, ensuring the production of transfusion-ready plasma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If standard filters are used to filter reconstituted plasma, then filtration is simple and quick, but microscopic needle-like fibers pass through the filter and render plasma unsuitable for transfusion
Solution Approach 1:
The filter is divided into multiple layers with different pore sizes and structures. The first layer has larger pores for initial filtration, while subsequent layers have progressively smaller pores to trap progressively smaller particles including needle-like fibers. This segmented approach allows each layer to perform a specific filtration function, achieving comprehensive particle removal without requiring an excessively complex single-layer filter.
Solution Approach 2:
The filter incorporates a tortuous path design where fluid must travel through a winding, non-linear path rather than straight through the filter media. This dimensional transformation of the flow path increases the effective filtration distance and allows particles to be trapped by multiple layers sequentially, preventing them from reaching the outlet even if they could pass through individual pore structures.
2Reliability
If FFP is stored frozen and thawed within 24 hours prior to transfusion, then plasma quality is maintained, but the absence of freezer and thawer facilities delays plasma administration in trauma settings
Solution Approach 1:
The plasma is dried and filtered in advance, with the filter pre-assembled and ready for use. This preliminary preparation eliminates the need for last-minute thawing operations, allowing the plasma to be administered immediately after reconstitution without requiring freezer or thawer facilities at the point of care.
Solution Approach 2:
The plasma is transformed from a frozen state requiring thermal processing to a dried state that can be stored at ambient temperature and reconstituted rapidly. This parameter change in storage temperature and physical state eliminates the time-consuming thawing step while maintaining plasma quality through the protective filtration and drying process.
3Reliability
If dried plasma products are pooled from multiple donors, then plasma availability is improved, but contamination with viral pathogens occurs
Solution Approach 1:
The harmful viral pathogens and contaminated particles are extracted and removed from the plasma through the tortuous path filter. The filter physically separates and traps these harmful substances while allowing the beneficial plasma components to pass through, thereby eliminating the contamination risk associated with pooled plasma products.
Solution Approach 2:
The needle-like fibers and particulate matter that initially seemed to be harmful contaminants are actually converted into a beneficial filtration mechanism. These fibers form the tortuous path structure that actively traps viral pathogens and other harmful substances, transforming potential contaminants into the very mechanism that protects against contamination.
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 tortuous path filter effectively removes transfusion-preventing particles, producing plasma that meets USP 788 and ANSI/AAMI BF7 standards, enabling rapid and safe plasma transfusions even in resource-constrained environments.
Implementation Method 1
A tortuous path filter comprising multiple layers of fibers, beads, or single-layer filters without pores larger than 100 microns along a straight path, designed to trap and remove these fibers
Data Source
AI summary
A tortuous path filter for filtering reconstituted plasma, the filter comprising at least two layers of fibers, single-layer filters, or beads, wherein the filter lacks or substantially lacks pores defining a lumen, said lumen having a diameter of larger than (100) microns along a straight path through the filter. The invention provides devices including a tortuous path filter, and methods for producing transfusion-ready plasma comprising: (a) reconstituting dried plasma to produce reconstituted plasma; and (b) passing said reconstituted plasma through the tortuous path filter to produce transfusion-ready plasma.