Variable Ratio Biomedical Coating Delivery Device

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Solution Overview

Problem

Current biomedical coatings lack flexibility to address multiple clinical needs such as closure, leakage prevention, and adhesion prevention simultaneously, as they typically have pre-determined properties that cannot be altered during surgery to suit different requirements.

Innovation Solution

A device and method for delivering a multi-part biomedical composition with varying mixing ratios, allowing for the formation of hydrogels with gradient or step-wise changes in composition and properties across the tissue surface, enabling simultaneous functions as a surgical adhesive, sealant, and adhesion preventative.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If a biomedical coating is designed with high cross-link density to provide strong adhesive properties, then mechanical strength is improved, but swellability decreases and the material becomes less effective as an adhesion preventative

Engineering Contradiction:

Improvemechanical strengthVSAvoidadhesion prevention capability

Core Design Contradiction:

StrengthVSAdaptability or versatility

Solution Approach 1:

The coating is designed with spatially varying cross-link density: the region adjacent to the tissue substrate has high cross-link density for strong adhesion, while the outer region has low cross-link density for adhesion prevention. This gradient structure allows different zones of the same coating to perform different functions simultaneously.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The coating is divided into multiple zones with distinct cross-link density characteristics. The inner zone (near tissue) provides structural support and bonding, while the outer zone provides lubrication and prevents adhesion, effectively segmenting the functional requirements.

Inventive Principle:

Principle #1Segmentation

2Reliability

If a single biomedical coating composition is used to address one clinical need (e.g., adhesion prevention), then the coating performs that specific function well, but it cannot be adapted to address other clinical needs (e.g., sealing, hemostasis) during surgery

Engineering Contradiction:

Improveperformance in specific clinical applicationVSAvoidflexibility to address multiple clinical needs

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The coating composition is made dynamically adjustable during application. The system allows real-time modification of cross-link density and compositional ratios, enabling the surgeon to adapt the coating's properties to match different clinical requirements encountered during the procedure.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The invention enables continuous adjustment of key parameters including cross-link density, polymer concentration, and compositional ratios. By changing these parameters, the same base coating system can be tuned to provide different levels of adhesion, sealing, or adhesion prevention as needed.

Inventive Principle:

Principle #35Parameter changes

3Adaptability or versatility

If a multi-part composition is delivered with variable mixing ratios to achieve gradient properties, then adaptability and versatility are improved, but device complexity increases

Engineering Contradiction:

Improveability to form coatings with varying propertiesVSAvoidcomplexity of delivery device

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The delivery device uses a nested structure where multiple syringes containing different components are positioned concentrically or in close proximity. This allows simultaneous delivery of multiple components with precise control over their mixing ratios, while maintaining a compact and manageable device architecture.

Inventive Principle:

Principle #7Nested doll (Nesting)

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

Provides a surgeon with the flexibility to address multiple clinical needs by forming hydrogels with adjustable cross-link density, allowing for a coating that can function as both an adhesive and adhesion preventative, enhancing surgical outcomes by preventing unwanted adhesions and leakage.

Implementation Method 1

These materials polymerize to achieve the strength required

Methodology Applied

Scientific EffectPolymerization: Photopolymerisation

Implementation Method 2

The performance characteristics of the hydrogel products are intimately related to cross-link density

Methodology Applied

Scientific EffectCross-linking: Chemical Bonding

Data Source

PatentUS10828018B2Methods and devices for forming biomedical coatings using variable mixing rations of multi-part compositions

Publication Date: 2020.11.10 ETHICON INC

AI summary

The present invention relates devices capable of continuous and simultaneous expression of components of a multi-part biomedical composition with variable mixing ratios. The device has at least two syringes that contain the inter-reactive components of the multi-part biomedical composition. At least the barrel of the first syringe has a first retention compartment having a cross-sectional area dimension that is larger than the cross-sectional area of a second retention compartment. The first piston has a cross-sectional dimension that matches the inside cross-sectional dimension of the small dimensioned retention compartment, while a ring-shaped gasket is located within the large dimensioned retention compartment and has an outside cross-sectional dimension that matches an interior dimension of the large dimension retention compartment.