Self-cohered Bioabsorbable Web for Haemostasis
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Solution Overview
Problem
Existing bioabsorbable polymeric web materials lack high porosity, mechanical strength, loft, suppleness, drapability, and tissue compliance, which are essential for advanced medical applications such as haemostasis and implantable devices.
Innovation Solution
A synthetic bioabsorbable, non-woven, self-cohered polymeric web material with high porosity is developed by stretching unannealed precursor web materials in one or more directions and subsequent heat-setting, resulting in a web with increased void space and improved mechanical properties.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the web material is made with self-cohered filaments having multiple contact points, then the material achieves structural coherence without adhesives, but the porosity is limited to 40-80% which is insufficient for advanced medical applications
Solution Approach 1:
The continuous filaments are segmented into discontinuous filaments through controlled breaking during web formation. This segmentation creates more interstitial spaces between filament ends, significantly increasing porosity from 40-80% to above 80% while maintaining structural coherence through the distributed arrangement of filament segments
Solution Approach 2:
The filament contact points are modified by changing the bonding mechanism from direct point-to-point contact to a distributed bonding pattern. The web structure parameters are adjusted by controlling filament deposition density and arrangement, creating a more open network structure that achieves high porosity while maintaining mechanical integrity
2Adaptability or versatility
If the web material porosity is increased to improve haemostatic properties and tissue compliance, then the material becomes more compliant with tissue, but the mechanical strength of the web material decreases
Solution Approach 1:
The web material exhibits local quality variations where different regions have optimized properties: the filament bonding zones provide localized mechanical strength, while the interstitial spaces provide porosity and tissue compliance. This spatial differentiation allows the material to simultaneously achieve high porosity (>80%) and adequate mechanical strength for surgical applications
Solution Approach 2:
The web material functions as a composite structure combining discontinuous filaments with controlled void spaces. The filament network provides the load-bearing framework, while the porosity provides tissue compliance and haemostatic functionality, creating a composite material that achieves both mechanical strength and tissue compliance
3Adaptability or versatility
If the web material is made with finer filaments to increase surface area and porosity, then the material achieves better tissue compliance and haemostatic properties, but the manufacturing complexity increases
Solution Approach 1:
The filament fabrication process is self-regulating, where the spinning conditions automatically produce filaments with optimal diameter and uniformity. The self-cohesion mechanism inherently creates the desired web structure without requiring complex post-processing, reducing manufacturing complexity while achieving the required filament fineness for tissue compliance
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 highly porous web material exhibits enhanced mechanical strength, loft, suppleness, and tissue compliance, making it suitable for implantable medical devices and haemostatic applications, with the ability to combine with additional components for enhanced functionality.
Implementation Method 1
The continuous filaments are produced by selecting spinning conditions that provide a tackiness to the emerging filaments and allows them to self-cohere as solid filaments as the filaments are collected in a cohesive random pile, or web, on a collecting surface. The self-cohered filaments have multiple contact points with each other within the web. The self-cohered filaments bond at the contact points without need for requisite addition of supplementary adhesives, binders, adhesive adjuncts
Implementation Method 2
If the potentially semi-crystalline web is preserved in a thermodynamically unstable (metastable), homogeneous (microphase disordered), substantially phase miscible, amorphous state of limited crystallinity, the web is malleable and can be readily conformed or molded into a desired shape. That shaped form can then be preserved through its conversion into a more ordered, thermodynamically stable, at least partially phase immiscible semi-crystalline state
Implementation Method 3
This irreversible (short of complete remelting and reformation of the formed web structures) conversion from a prolonged amorphous (i.e., disordered state of miscibility) condition into an ordered semi-crystalline state is typically provided by the chain mobility present in the rubbery state existing between the melt temperature and that of the order-disorder transition temperature (T odt ), the temperature above which the transition from disorder to order can proceed
Data Source
Figure 1
Figure 1A
Figure 2~2A
AI summary
The present invention is directed to implantable bioabsorbable non-woven self-cohered web materials having a high degree of porosity. The web materials are very supple and soft, while exhibiting proportionally increased mechanical strength in one or more directions. The web materials often possess a high degree of loft. The web materials can be formed into a variety of shapes and forms suitable for use as implantable medical devices or components thereof. The web materials possess haemostatic properties.