Flowable Adjunct Precursor for Tissue Sealing and Stapling

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Solution Overview

Problem

Surgical staplers often cause leaks and inflammation due to the trauma of stapling, and the materials used lack the natural flexibility and characteristics of the tissue they are implanted in, leading to suboptimal healing and tissue damage.

Innovation Solution

A method and device for delivering and securing adjunct materials to the treatment site by applying a flowable precursor that solidifies before staples are inserted, providing a flexible and biocompatible interface that minimizes trauma and promotes healing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If surgical staplers are used to close openings in tissue, then the tissue can be secured and closed, but leaks can occur due to holes formed when staples penetrate the tissue and inflammation can occur due to trauma

Engineering Contradiction:
Improvesealing effectivenessVSAvoidtissue trauma and inflammation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The sealant is applied to the tissue before the staples are inserted. This preliminary application creates a protective barrier on the tissue surface that will be covered by the staples, preventing direct trauma from the staple penetration and sealing the puncture holes formed by the staples.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The sealant acts as an intermediary material between the tissue and the staples. It provides a protective interface that reduces the harmful effects of staple penetration while maintaining the sealing function, thereby mediating between the mechanical fastening requirement and the tissue protection requirement.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Strength

If staples are used to secure tissue, then the tissue can be fastened, but the natural characteristics and flexibility of the tissue are compromised

Engineering Contradiction:
Improvetissue fasteningVSAvoidtissue flexibility
Core Design Contradiction:
StrengthVSAdaptability or versatility

Solution Approach 1:

The sealant changes its physical parameters from a liquid or gel state during application to a solid or semi-solid state after setting. This parameter change allows the material to be applied easily in a fluid state, then transform to provide structural support and maintain tissue flexibility in its final state, accommodating tissue movement while providing fastening strength.

Inventive Principle:
Principle #35Parameter changes

3Strength

If rigid materials are used for stapling, then the fastening strength is improved, but the natural motion and flexibility of the tissue are restricted

Engineering Contradiction:
Improvefastening strengthVSAvoidtissue motion capability
Core Design Contradiction:
StrengthVSDuration of action of moving object

Solution Approach 1:

The sealant forms a flexible coating or film on the tissue surface. This flexible layer provides the necessary fastening strength to hold the tissue together while allowing the tissue to move and deform naturally, unlike rigid materials that would restrict tissue motion and potentially cause damage during physiological movements.

Inventive Principle:
Principle #30Flexible shells and thin films

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 effectively reduces leaks and inflammation, maintains the natural characteristics of the tissue, and enhances healing by providing a flexible interface that allows for natural tissue motion and reduces staple pull-through, thereby improving the integrity of the stapled region.

Implementation Method 1

a flowable adjunct precursor is delivered to a tissue and, after the flowable adjunct precursor solidifies to form an adjunct

Methodology Applied
Scientific EffectSolidification: Phase Change

Data Source

PatentUS10478280B2Methods and devices for delivering and securing adjunct materials to a treatment site
Publication Date: 2019.11.19 CILAG GMBH INTERNATIONAL
  • US10478280B2 patent drawing
  • US10478280B2 patent drawing
  • US10478280B2 patent drawing

AI summary

Devices and methods for placing an adjunct at a tissue treatment site prior to delivering staples through the tissue and adjunct are provided. In one embodiment, a flowable adjunct precursor can be deposited on the surface of the tissue at the tissue treatment site. The flowable adjunct precursor can be configured to solidify after deposition to form an adjunct. In another embodiment, an adjunct delivery device can include a non-stapling end effector configured to deliver an adjunct to a tissue treatment site. In either case, staples can be delivered through the adjunct and tissue after placement of the adjunct at the tissue treatment site.