pH-Controlled Tissue Sealant Mixing for Variable Cross-Linking

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Existing biocompatible sealing compositions lack the ability for surgeons to dynamically control the cross-linking rates and properties of reactive components during surgical applications, limiting their versatility in addressing multiple clinical needs such as sealing, adhesion, hemostasis, and adhesion prevention.

Innovation Solution

A system and method using an applicator instrument that delivers biocompatible sealing compositions with varying mixing ratios of reactive components and a pH modifying fluid, allowing for controlled cross-linking rates by adjusting the flow rate of the pH modifying fluid during application, forming physiologically distinct layers or zones with different cross-linking characteristics.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a pre-determined cross-linking rate is used in biocompatible sealing compositions, then the product provides consistent performance for a specific clinical need, but the surgeon cannot alter the properties to address different clinical needs during surgery

Engineering Contradiction:

Improveperformance consistencyVSAvoidclinical need flexibility

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent implements a dynamic delivery system where the flow rate of pH modifying fluid can be adjusted in real-time during surgical application. This allows the cross-linking rate to be dynamically controlled, enabling the same product to adapt to different clinical needs (sealing, adhesion, hemostasis, adhesion prevention) while maintaining reliable performance through controlled parameter adjustment

Inventive Principle:

Principle #15Dynamics

2Strength

If a high cross-link density is used in hydrogel products, then mechanical strength is high, but water swellability is low

Engineering Contradiction:

Improvemechanical strengthVSAvoidwater swellability

Core Design Contradiction:

StrengthVSQuantity of substance

Solution Approach 1:

The patent enables different regions of the applied composition to have different cross-link densities by controlling the local concentration of pH modifying fluid. This allows the surgeon to create zones with high cross-link density for strength where needed, and zones with lower cross-link density for swellability where needed, within the same application

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The patent changes the chemical parameter (pH) locally by controlling the flow rate of pH modifying fluid delivery. This parameter change directly controls the cross-linking reaction rate, enabling dynamic adjustment of both mechanical strength and water swellability properties during application

Inventive Principle:

Principle #35Parameter changes

3Speed

If the cross-linking reaction proceeds rapidly, then the product solidifies quickly to stay in place, but the surgeon loses control over the degree of curing

Engineering Contradiction:

Improvecross-linking rateVSAvoidcuring control

Core Design Contradiction:

SpeedVSEase of operation

Solution Approach 1:

The patent implements feedback control through a delivery system that monitors and adjusts the flow rate of pH modifying fluid based on the desired cross-linking rate. This allows the surgeon to maintain control over the curing process while achieving the desired speed of solidification for the product to stay in place

Inventive Principle:

Principle #23Feedback

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

Enables surgeons to tailor the properties of the sealing composition in real-time, enhancing its effectiveness in sealing and hemostasis by creating zones with varying cross-linking rates, thus improving surgical outcomes.

Implementation Method 1

a pH modifying fluid, which controls a rate of cross-linking of the first and second reactive components by changing a pH level

Methodology Applied

Scientific EffectpH modification:

Implementation Method 2

cross-linking rates of reactive components of biocompatible sealing compositions

Methodology Applied

Scientific EffectCross-linking:

Data Source

PatentUS12576183B2Methods and devices for changing the flow rates of pH modifying fluids for controlling cross-linking rates of reactive components of biocompatible sealing compositions

Publication Date: 2026.03.17 ETHICON INC

AI summary

A method of making a biocompatible composition for sealing tissue includes mixing a first fluid having a first reactive component (e.g., an electrophile) and a second fluid having a second reactive component (e.g., a nucleophile) to form a mixture and expressing the mixture. During expression, a pH modifying fluid (e.g., NaOH) is added to the mixture at a rate that changes. In one embodiment, a higher ratio of the pH modifying fluid is added to the mixture during a first expressing stage and a lower ratio of said pH modifying fluid is added to the mixture during a second expressing stage. During the first expressing stage, a mixing ratio of the pH modifying fluid, the first fluid and the second fluid is 0.7-1.4:1:1. During the second expressing stage, the mixing ratio of the pH modifying fluid, the first fluid and the second fluid is 0.12-0.24:1:1.