Tissue Sealant Composition Resists Washout

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Solution Overview

Problem

Current tissue sealants for cardiovascular and gastrointestinal applications are ineffective due to washout by body fluids, weak adhesive properties, toxicity, and inability to withstand mechanical forces within cardiac chambers and major blood vessels, limiting their use in minimally invasive surgical procedures.

Innovation Solution

A composition comprising a pre-polymer with a specific polymeric unit structure, activated with acrylate groups and controlled anhydride content, which is cured using light in the presence of a photoinitiator to form a biocompatible, biodegradable sealant with enhanced adhesive and sealant properties.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If current clinically-available sealants (medical grade cyanoacrylate or fibrin sealant) are used, then they can provide initial sealing capability, but they are easily washed out by body fluids and cannot withstand mechanical forces inside cardiac chambers and major blood vessels

Engineering Contradiction:
Improvesealant strengthVSAvoidresistance to washout by body fluids
Core Design Contradiction:
StrengthVSReliability

Solution Approach 1:

The patent changes the chemical parameters of the sealant by using a two-part composition where Part A contains a polyester polymer with specific functional groups and Part B contains a crosslinking agent. This chemical parameter change enables the sealant to achieve both strong adhesion and resistance to washout by body fluids through covalent bonding upon mixing.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs a composite material system consisting of two distinct parts (Part A: polyester polymer solution and Part B: crosslinking agent solution) that are mixed just before application. This composite approach combines the adhesive properties of the polyester with the crosslinking capabilities of the second agent, creating a sealant that resists washout while maintaining strong bonding strength.

Inventive Principle:
Principle #40Composite materials

2Speed

If sealants are designed to activate rapidly upon contact with water, then they can provide immediate sealing, but this makes fine adjustments or repositioning of devices very difficult

Engineering Contradiction:
Improveactivation speedVSAvoidrepositioning capability
Core Design Contradiction:
SpeedVSEase of operation

Solution Approach 1:

The patent applies preliminary action by keeping the sealant components separate (Part A and Part B) until the moment of application. The device can be positioned and adjusted with the components still separate, and only upon final positioning do the components mix and activate. This delayed activation allows for easy repositioning while still providing rapid sealing once the decision to activate is made.

Inventive Principle:
Principle #10Preliminary action

3Strength

If sealants rely on chemical reaction with functional groups at the tissue surface, then they can achieve adhesion, but they become ineffective in the presence of blood

Engineering Contradiction:
Improveadhesive strengthVSAvoidinterference by blood
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent uses an intermediary approach by employing a two-component system where the interaction between Part A (polyester polymer) and Part B (crosslinking agent) creates a sealed matrix that mechanically interlocks with tissue rather than relying solely on surface chemical reactions. This intermediary mechanism allows the sealant to maintain adhesive strength even in the presence of blood, as the crosslinked network provides structural integrity independent of tissue surface chemistry.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 solution provides a stable, non-toxic tissue sealant that remains in place, resists washout by bodily fluids, and exhibits strong adhesive and sealant forces, even in dynamic conditions, facilitating minimally invasive procedures with minimal inflammatory response and biodegradability.

Implementation Method 1

cured using light in the presence of a photoinitiator

Methodology Applied
Scientific EffectPhotopolymerisation: Photopolymerisation

Data Source

PatentUS11898005B2Sealant composition
Publication Date: 2024.02.13 TISSIUM SA
  • US11898005B2 patent drawing
  • US11898005B2 patent drawing
  • US11898005B2 patent drawing

AI summary

A composition with improved adhesive and sealant properties comprising a pre-polymer comprising a polymeric unit of the general formula (1A1B-)n, wherein A represents a substituted or un-substituted ester, B represents a substituted or un-substituted acid ester comprising at least two acid ester functionalities, and n represents an integer greater than 1, wherein the compositions has a grafted anhydride content of less than about 0.05 mol/mol of polyacid.