Compressible Adjuncts for Surgical Stapling

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Solution Overview

Problem

Surgical staplers often result in leaks and tissue inflammation due to staple formation holes, as existing materials fail to effectively manage fluid movement and trauma during the stapling process.

Innovation Solution

Compressible adjuncts with biocompatible materials featuring lattice structures and absorbable sub-structures, such as duck bill valves and micro-passageways, are used to control fluid movement and deliver drugs, reducing leaks and inflammation by enhancing tissue healing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If surgical staplers are used to close openings in tissue, then tissue sealing is achieved, but leaks occur due to staple formation holes allowing fluid seepage

Engineering Contradiction:

Improvetissue sealing effectivenessVSAvoidfluid leakage through staple holes

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

A compressible adjunct material is introduced as an intermediary component between the staples and the tissue. This adjunct is delivered through the stapler along with the staples and remains at the stapled site to seal the holes created by staple formation, preventing fluid leakage while the staples provide mechanical closure.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The compressible adjunct utilizes a porous structure that allows it to be compressed during delivery through the stapler and then expand at the target site. This porous material can absorb fluids and conform to the tissue, effectively sealing the staple holes while maintaining biocompatibility.

Inventive Principle:

Principle #31Porous materials

2Reliability

If surgical staplers are used to close tissue openings, then tissue closure is achieved, but tissue inflammation occurs due to trauma from stapling

Engineering Contradiction:

Improvetissue closure effectivenessVSAvoidtissue inflammation

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The compressible adjunct serves as a cushioning element that is placed on the tissue before the staples are fully formed. It protects the tissue from direct trauma during the stapling process and continues to provide a protective barrier during healing, reducing inflammation caused by staple formation.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

Solution Approach 2:

The adjunct is constructed from composite materials that combine biocompatible polymers with hemostatic and anti-inflammatory agents. This composite structure allows the material to provide mechanical protection while simultaneously delivering therapeutic substances that reduce tissue trauma and inflammation.

Inventive Principle:

Principle #40Composite materials

3Reliability

If compressible adjuncts with lattice structures are used to control fluid movement, then fluid management is improved, but device complexity increases

Engineering Contradiction:

Improvefluid movement controlVSAvoidadjunct structure complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The lattice structure of the adjunct is segmented into multiple interconnected struts and cells, creating a hierarchical architecture. This segmentation allows the structure to control fluid movement at multiple scales while maintaining overall simplicity through repetitive geometric patterns that can be manufactured using additive manufacturing techniques.

Inventive Principle:

Principle #1Segmentation

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 compressible adjuncts effectively manage fluid movement and deliver drugs to promote healing, reducing leaks and inflammation, and improving the outcomes of surgical stapling procedures.

Implementation Method 1

The at least one absorbable sub-structure is configured to control fluid movement through the adjunct material such that the fluid movement impacts healing of tissue adjacent the adjunct material

Methodology Applied

Scientific EffectCapillary action: Capillary Action

Implementation Method 2

Compressible adjuncts with biocompatible materials featuring lattice structures and absorbable sub-structures

Methodology Applied

Scientific EffectCompression: Compression

Data Source

PatentUS11850332B2Method for treating tissue

Publication Date: 2023.12.26 CILAG GMBH INTERNATIONAL

AI summary

Methods for treating tissue are provided. In one embodiment, an adjunct material, when secured to tissue, can receive at least one physiological element released from the tissue during healing progression of the tissue, and can exhibit first and second stiffnesses in compression that are approximately constant during first and second time periods from contact with the tissue, with the second stiffness decreasing with time as a function of at least one of oxidation, enzyme-catalyzed hydrolysis, and change of pH resulting from interaction with the at least one physiological element. In another embodiment, the adjunct can receive a unit volume of fluid that causes first and second portions of the adjunct to expand according to first and second expansion behaviors that differ from one another to apply different pressures to the tissue.