Hemostatic Patch Matrix With PEG Adhesive for Tissue Leak Sealing
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Solution Overview
Problem
Existing surgical techniques for managing post-operative bleeding, fluid leaks, and air leaks during organ resections, such as liver, lung, and gastrointestinal procedures, are inadequate due to adhesive fluids that flow off or lack adequate adherence, and current hemostatic patches are rigid and non-compliant with tissue movements.
Innovation Solution
A system involving a flexible, biodegradable synthetic matrix with sequentially deposited reactive polyalkylene oxide-based components (PEG-NHS and PEG-NH2) forms a gel-like mechanical barrier and adheres to tissue, providing a seal that is independent of the patient's clotting status.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If adhesive fluids are used to seal resected surfaces, then sealing capability is improved, but the adhesive fluids flow off the resected surface prior to curing or peel off after curing due to inadequate adherence
Solution Approach 1:
The patent uses a composite material system combining a flexible biodegradable synthetic matrix with biosynthetic adhesive components. This composite structure provides both the mechanical support needed to prevent fluid flow and the adhesive properties needed for tissue bonding, resolving the contradiction between sealing capability and adherence strength
Solution Approach 2:
The patent modifies the physical and chemical parameters of the adhesive system by using a flexible biodegradable matrix that can adapt to tissue movement. This parameter change allows the adhesive to maintain both its sealing function and strong adherence to tissue under dynamic conditions
2Reliability
If rigid hemostatic patches are used to seal tissue, then hemostatic effect is improved, but the patches do not conform to tissue movements
Solution Approach 1:
The patent transitions from a static rigid patch to a dynamic flexible matrix system that can move and deform with tissue. This dynamic design maintains hemostatic effectiveness while adapting to tissue movements, resolving the contradiction between hemostatic effect and conformance
Solution Approach 2:
The patent employs a flexible biodegradable synthetic matrix that functions as a compliant barrier. This flexible film structure provides hemostatic effect while conforming to tissue movements, directly addressing the contradiction between rigidity and adaptability
3Reliability
If extensive suturing is used to manage bleeding, then hemostatic control is improved, but surgical time and complexity increase
Solution Approach 1:
The patent extracts the hemostatic function from the time-consuming suturing process and encapsulates it in a pre-prepared flexible matrix with biosynthetic adhesive. This allows hemostatic control to be achieved through simple application rather than extensive surgical intervention, resolving the contradiction between effectiveness and time
Solution Approach 2:
The patent prepares the hemostatic matrix and adhesive components in advance, combining multiple functions (hemostasis, sealing, adhesion) into a single pre-assembled system. This preliminary preparation eliminates the need for time-consuming intraoperative procedures, achieving both effective hemostatic control and reduced surgical 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 effectively seals tissue surfaces, preventing bleeding, fluid leaks, and air leaks by forming a strong, flexible, and adhesive seal that conforms to tissue movements, even in patients on anticoagulant therapy.
Implementation Method 1
the PEG-NHS and PEG-NH2 components tend to cross-link forming a gel-like mechanical barrier that may stop bleeding
Implementation Method 2
forming a gel-like mechanical barrier
Implementation Method 3
the PEG-NHS cross-links with tissue proteins' NH2 groups, thereby leading to adhesion of the prototypes to the tissue
Data Source
AI summary
The present invention is directed to a hemostatic patch comprising a porous substrate and at least a pair of co-reactive polymer reagents comprising at least one nucleophilic polyalkylene oxide based component and at least one electrophilic polyalkylene oxide-based on the porous substrate in a molar ratio of about 0.2 to about 0.9:1 of primary nucleophilic groups in excess to available electrophilic groups. The present invention is also directed to processes for the manufacture and use of such hemostatic patches.