Polymeric Tissue Sealant with Rapid Gelation and Low Swelling
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Solution Overview
Problem
Current tissue sealants and adhesives face limitations such as low mechanical strength, biocompatibility issues, and handling difficulties, including swelling and tissue irritation, which hinder their effectiveness in surgical settings, particularly in sealing cerebrospinal fluid leaks during brain or spinal surgery.
Innovation Solution
A synthetic biomaterial composition comprising a first precursor molecule with multiple nucleophilic groups and a second precursor molecule with multiple electrophilic groups, capable of forming a crosslinked three-dimensional network under physiological conditions, using poly(ethylene glycol) based polymers and multiarm poly(ethylene oxide-polypropylene oxide) block copolymers, which rapidly gel and provide mechanical strength while minimizing swelling and being completely resorbable.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If mechanical fasteners (clamps, staples, sutures) are used to join damaged tissues, then tissue integrity can be restored, but the procedure becomes time-consuming, requires significant skill, and can leak along the line of joinder causing additional trauma
Solution Approach 1:
The patent replaces mechanical fastening systems (clamps, staples, sutures) with a chemical bonding system using two-component adhesives that polymerize to form strong bonds between tissue surfaces. This substitution eliminates the need for mechanical intervention, reducing surgical time and skill requirements while maintaining reliable tissue integrity restoration.
Solution Approach 2:
The patent utilizes changes in physical and chemical parameters during the adhesive curing process. The two-component system undergoes polymerization transformation, changing from liquid state to solid gel state, which provides rapid bonding without requiring prolonged surgical procedures or complex mechanical application techniques.
2Reliability
If mechanical fasteners are used to join tissues, then tissue connection can be achieved, but the fasteners can be ineffective in highly vascularized organs and require significant skill to apply
Solution Approach 1:
The patent replaces complex mechanical fastening operations with simple adhesive application. The two-component adhesive system requires only mixing and application to tissue surfaces, eliminating the need for surgical skill in manipulating clamps, staples, or sutures, while providing effective connection even in highly vascularized organs where mechanical fasteners fail.
3Reliability
If fibrin-based adhesives are used as tissue sealants, then tissue bonding can be achieved, but the sealing strength is low and there is risk of transfection from human blood derived products
Solution Approach 1:
The patent changes the chemical composition parameters of the adhesive system by using synthetic polymers instead of blood-derived fibrin. This parameter change eliminates transfection risks associated with human blood products while simultaneously increasing sealing strength through controlled polymerization of the two-component system, achieving both safety and mechanical performance.
Solution Approach 2:
The patent employs composite material design by combining two different polymer components that react together to form a cross-linked network structure. This composite approach provides superior mechanical strength compared to single-component fibrin adhesives, while the synthetic composition eliminates biological contamination risks.
4Reliability
If gelatin-based glues cross-linked with aldehyde are used, then tissue bonding can be achieved, but tissue irritation occurs and hot gelatin solutions are required
Solution Approach 1:
The patent changes the temperature parameter from hot gelatin solutions to room temperature or physiological temperature application. The two-component synthetic adhesive system cures at lower temperatures, eliminating thermal damage to tissues. Additionally, the cross-linking mechanism changes from aldehyde-based (which causes irritation) to polymerization-based, eliminating chemical irritation while maintaining bonding effectiveness.
5Strength
If synthetic polymers like cyanoacrylates and polyurethanes are used as tissue sealants, then mechanical strength can be improved, but handling properties deteriorate and swelling occurs
Solution Approach 1:
The patent optimizes the viscosity and reactivity parameters of the two-component adhesive system to achieve ideal handling properties. The components are formulated to remain pumpable and easy to mix at room temperature, then undergo rapid polymerization upon mixing. This parameter optimization provides both excellent handling characteristics and high mechanical strength, while the cross-linked network structure minimizes water uptake and swelling compared to other synthetic polymers.
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 biomaterial effectively seals tissue defects with rapid gelation, high mechanical strength, and minimal swelling, reducing fluid loss and promoting healing, while being fully resorbable, thus addressing the limitations of existing tissue sealants and adhesives.
Implementation Method 1
The nucleophilic and electrophilic groups of the first and second precursor molecules are capable of forming covalent linkages with each other under physiological conditions
Implementation Method 2
capable of forming a crosslinked three-dimensional network under physiological conditions, using poly(ethylene glycol) based polymers and multiarm poly(ethylene oxide-polypropylene oxide) block copolymers, which rapidly gel and provide mechanical strength
Data Source
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AI summary
Methods for making biomaterials for use as a tissue sealant, kits containing precursors for forming the biomaterials, and the resulting biomaterials are described herein. The biomaterials are formed from a composition comprising at least a first and a second precursor molecule, wherein: i) the first precursor molecule is a poly(ethylene glycol) based polymer having x nucleophilic groups selected from the group consisting of thiol or amino groups, wherein x is equal to 2 or greater than 2, preferably 3, 4, 5, 6, 7 or 8; ii) the second precursor molecule is of the general formula: A-[(C 3 H 6 O) n -(C 2 H 4 O) m -B] i wherein m and n are integers from 1 to 200 i is greater than 2, preferably 3, 4, 5, 6, 7 or 8 A is a branch point B is a conjugated unsaturated group.