Haemostatic Sheet with Reactive Polymer Particles
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Solution Overview
Problem
Current surgical hemostatic products are inadequate for controlling bleeding during procedures on parenchymatous tissues like the liver or kidneys, as they often require additional methods beyond suture control, electrocautery, or ultrasonic sealing.
Innovation Solution
A biocompatible, flexible haemostatic sheet with a cohesive fibrous carrier structure and reactive polymer particles that contain electrophilic and nucleophilic groups, capable of forming covalent bonds with tissue and blood proteins to induce rapid coagulation and tissue sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional suture control, electrocautery, or ultrasonic sealing is used, then bleeding control may be achieved, but these methods are insufficient for parenchymatous tissue and require multiple additional approaches
Solution Approach 1:
The patent combines multiple hemostatic mechanisms into a single sheet product: physical absorption of blood, chemical coagulation activation, and adhesive tissue bonding. The fibrous carrier structure provides mechanical absorption while reactive polymer particles deliver chemical coagulation factors and adhesive properties, eliminating the need for separate suture, electrocautery, or ultrasonic sealing steps.
Solution Approach 2:
The sheet uses a composite structure combining a fibrous carrier material (for absorption and mechanical strength) with reactive polymer particles (for coagulation and adhesion). This composite approach integrates multiple functional properties into one material system, providing reliable hemostasis for parenchymatous tissue without requiring multiple separate devices or methods.
2Strength
If a hydrogel is formed to adhere to tissue, then mechanical strength and sealing are improved, but swelling control becomes challenging
Solution Approach 1:
The patent creates local quality differentiation within the sheet structure: the fibrous carrier regions provide mechanical strength and controlled swelling, while the reactive polymer particle regions provide adhesion and coagulation. This spatial differentiation allows the hydrogel to adhere strongly to tissue at the interface while the fibrous bulk structure limits overall swelling through its inherent mechanical constraints.
3Reliability
If reactive polymer particles are distributed in the interstitial space, then covalent bonding with tissue and blood is enhanced, but the structure becomes more complex
Solution Approach 1:
The fibrous carrier structure inherently provides a porous interstitial network that naturally accommodates and distributes reactive polymer particles. This porous architecture, designed for blood absorption, simultaneously serves as a distribution matrix for the polymer particles, allowing them to be uniformly dispersed throughout the sheet thickness without requiring complex additional structuring or positioning mechanisms.
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 sheet effectively stops bleeding by forming a hydrogel that adheres to the tissue, providing mechanical strength and preventing excessive swelling, while being easily applicable to irregularly shaped bleeding sites and bioabsorbable.
Implementation Method 1
reactive electrophilic groups being capable of reacting with amine groups in tissue and blood under the formation of a covalent bond
Implementation Method 2
nucleophilic cross-linking agent that contains at least two reactive nucleophilic groups that are capable of reacting with the reactive electrophilic groups of the electrophilic polymer under the formation of a covalent bond
Implementation Method 3
cohesive fibrous carrier structure comprising a three-dimensional interconnected interstitial space
Data Source
AI summary
The invention relates to a biocompatible, flexible, haemostatic sheet comprising: • a cohesive fibrous carrier structure comprising a three-dimensional interconnected interstitial space; and • distributed within the interstitial space, a plurality of reactive polymer particles comprising (i) a water-soluble electrophilic polymer carrying at least 3 reactive electrophilic groups that are capable of reacting with amine groups in tissue and blood under the formation of a covalent bond and (ii) a nucleophilic cross-linking agent that contains at least two reactive nucleophilic groups that are capable of reacting with the reactive electrophilic groups of the electrophilic polymer under the formation of a covalent bond, said reactive polymer particles having a diameter in the range of 0.5-100 pm and being present in an amount of at least 3% by weight of the fibrous carrier structure. When blood is absorbed by the haemostatic sheet of the present invention, the water-soluble electrophilic polymer in the reactive polymer particles starts dissolving as soon as these particles are 'wetted' by the blood, thereby allowing the electrophilic polymer to react with reactive nucleophilic groups in the blood and tissue, as well as with reactive nucleophilic groups of the nucleophilic cross-linking agent, thereby inducing blood coagulation and tissue sealing, both of which contribute to haemostasis.