Fibrinogen-Based Tissue Adhesive Patch with Controlled Degradation
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Solution Overview
Problem
Existing tissue adhesive patches remain intact for too long, exceeding the necessary duration for sealing wounds, leading to potential tissue irritation and a need for faster degradation without compromising sealing efficacy.
Innovation Solution
A fibrinogen-based tissue adhesive patch comprising a biocompatible polyethylene glycol-caprolactone-lactide (PEG-CL-LA) triblock copolymer film with a fibrinogen sealant, where the fibrinogen sealant is incorporated into the surface of the polymer backing to attach the patch to tissue, and the degradation time is controlled by adjusting the hydrophilic to hydrophobic component ratio, eliminating mesh or woven components.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the patch remains intact for a longer duration to ensure adequate sealing time, then sealing reliability is improved, but tissue irritation increases due to prolonged presence
Solution Approach 1:
The patent applies parameter changes by adjusting the hydrophilic to hydrophobic component ratio in the biocompatible polymer film to control degradation time. By modifying the chemical composition parameters of the polymer, the degradation rate is tuned to achieve optimal balance between maintaining sealing reliability (requiring sufficient integrity time) and minimizing tissue irritation (requiring timely degradation). This allows the patch to remain intact long enough to seal the wound effectively, then degrade within 10-14 days to eliminate irritation.
2Object-affected harmful factors
If the degradation time is reduced to minimize tissue irritation, then tissue compatibility is improved, but sealing durability may be compromised
Solution Approach 1:
The patent resolves this contradiction through parameter changes in the polymer composition, specifically controlling the hydrophilic to hydrophobic ratio to achieve a degradation time of 10-14 days. This optimized parameter range ensures the patch maintains sufficient structural integrity and adhesive strength throughout the critical sealing period while degrading quickly enough to minimize tissue irritation. The fibrinogen-based adhesive system also contributes by providing strong initial bonding that maintains sealing durability even as degradation progresses.
3Strength
If fibrinogen sealant is incorporated into the polymer surface to enhance adhesion, then adhesive strength is improved, but manufacturing complexity increases
Solution Approach 1:
The patent applies merging by integrating the fibrinogen sealant directly into the polymer film manufacturing process rather than applying it as a separate post-processing step. The fibrinogen-containing solution is incorporated into the polymer matrix during film formation, creating a unified structure where the adhesive and structural components are combined. This approach enhances adhesive strength while avoiding the complexity of multi-step assembly processes, as the fibrinogen becomes an intrinsic part of the polymer film structure.
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 patch effectively seals tissues for the required duration, degrading within 10-14 days, minimizing tissue irritation while maintaining adhesive strength and sealing ability, primarily through the polymer film's adhesive properties.
Implementation Method 1
a fibrinogen sealant, where the fibrinogen sealant is incorporated into the surface of the polymer backing to attach the patch to tissue
Implementation Method 2
the degradation time is controlled by adjusting the hydrophilic to hydrophobic component ratio
Data Source
AI summary
An improved fibrinogen-based tissue sealing patch having a degradation time of less than two weeks is disclosed. The patch comprises a polyethylene glycol-caprolactone-lactide (PEG-CL-LA) triblock copolymer film in which the PEG-CL-LA units are preferably connected by urethane linkages and into a surface of which a fibrinogen-based sealant comprising less than 8 mg/cm2 fibrinogen and less than 10 IU/cm2 thrombin has been incorporated. In preferred embodiments, the polymer film comprises PEG having a molecular weight of between 3000 and 3500 and a CL:LA:PEG ratio of 34:2:1. Methods of production and use of the patch are also disclosed.