Bio-absorbable Hernia Mesh Fastener Design
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Solution Overview
Problem
Current surgical fasteners for hernia repair, particularly metallic ones, cause permanent adhesions, migration, and pain due to their permanency and sharp edges, while bio-absorbable materials face challenges in achieving optimal mechanical properties, absorption times, and sterilization methods that maintain their strength and effectiveness.
Innovation Solution
A bio-absorbable hernia mesh fixation fastener made from d,l-lactide and glycolide co-polymers with a specific mole ratio, designed to have a 4-5 month absorption time and suitable mechanical properties, featuring a threaded tissue-snaring section for secure mesh fixation with minimal indentation, and a sterilization method using gamma or E Beam radiation to maintain mechanical integrity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If metallic fasteners are used for mesh fixation, then strong fixation is achieved, but permanent adhesions and migration occur
Solution Approach 1:
The patent changes the material parameter from permanent metal to bio-absorbable polymer, transforming the fastener from a permanent implant to a temporary fixation device that degrades over time. This resolves the contradiction by maintaining strong fixation during the critical healing period while eliminating permanent adhesions as the material is absorbed by the body.
Solution Approach 2:
The invention employs disposable, short-lived bio-absorbable fasteners that perform their fixation function temporarily and then dissolve. These fasteners are designed to be replaced by natural tissue growth, eliminating the need for permanent metallic implants and their associated complications like migration and chronic adhesion formation.
2Strength
If metallic fasteners with sharp edges are used, then secure fixation is achieved, but pain and tissue damage occur
Solution Approach 1:
The patent changes the material properties from sharp-edged metal to smooth bio-absorbable polymer, eliminating the harmful sharp edges while maintaining fixation capability through the polymer's mechanical properties and degradation characteristics.
3Object-generated harmful factors
If bio-absorbable materials are used for fasteners, then permanent adhesions are avoided, but mechanical strength and absorption time control are challenging
Solution Approach 1:
The patent uses composite polymer materials with specific molecular structures (polyglycolide-poly-L-lactide copolymers) that combine appropriate mechanical strength for fixation with controlled degradation rates. The composite nature of these biopolymers allows tuning of both strength and absorption characteristics to match the healing timeline.
Solution Approach 2:
The invention carefully controls material parameters including molecular weight, crystallinity, and copolymer ratio to achieve the desired balance between mechanical strength and absorption time. By adjusting these parameters, the fastener maintains sufficient strength during fixation while degrading at an optimal rate that matches tissue healing.
4Reliability
If sterilization methods are applied to bio-absorbable fasteners, then infection risk is reduced, but mechanical properties may be compromised
Solution Approach 1:
The patent replaces traditional mechanical/thermal sterilization methods (autoclaving, dry heat) with radiation-based sterilization (gamma or E-beam). This substitution allows effective sterilization without subjecting the bio-absorbable polymer to temperatures that would compromise its mechanical properties or accelerate unwanted degradation.
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 fastener provides secure mesh fixation with minimal tissue indentation, avoids long-term adhesions and pain, and maintains mechanical strength through controlled absorption and sterilization, ensuring effective hernia repair with reduced risk of complications.
Implementation Method 1
A method of sterilization using gamma or E Beam radiation to maintain mechanical integrity
Implementation Method 2
A method of sterilization using gamma or E Beam radiation to maintain mechanical integrity
Implementation Method 3
bio-absorbable materials face challenges in achieving optimal mechanical properties, absorption times
Data Source
AI summary
A method of forming and deploying an improved absorbable fastener for hernia mesh fixation is disclosed. The absorbable fastener of the present invention functions to securely fasten tough, non macro-porous, and relative inelastic mesh to soft tissue. The fastener is formed from co-polymers of lactide and glycolide.