Surgical Staple Cartridge Adjunct for Tissue Adhesion

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Solution Overview

Problem

Surgical staplers face issues with leaks and inflammation due to staple holes, and biologic materials used for tissue stapling are difficult to maintain and manufacture effectively, lacking natural tissue characteristics.

Innovation Solution

A staple cartridge assembly with a biocompatible adjunct material and medicant is used, which is deployed with staples to induce tissue adhesions, minimizing leaks and inflammation, and includes features like time-release mechanisms and growth factors to enhance healing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If surgical staplers are used to close tissue openings, then tissue closure is achieved, but leaks occur through staple holes and inflammation results from tissue trauma

Engineering Contradiction:
Improvetissue closure effectivenessVSAvoidleaks and inflammation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A biocompatible adjunct material is introduced as an intermediary between the staples and the tissue. This adjunct material fills the holes created by staples and promotes tissue adhesion, thereby preventing leaks and reducing inflammation while maintaining the tissue closure function

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The solution combines multiple materials with complementary properties: staples for mechanical closure, biocompatible adjunct material for hole filling and tissue adhesion promotion, and growth factors for enhanced healing. This composite approach addresses both the closure effectiveness and the harmful effects simultaneously

Inventive Principle:
Principle #40Composite materials

2Reliability

If biologic materials are used for tissue stapling, then tissue adhesion is promoted, but the materials are difficult to maintain at desired location and lack structural support

Engineering Contradiction:
Improvetissue adhesion promotionVSAvoidmaterial location control and structural support
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The biologic material is formulated as a thin film or coating that can be applied to the adjunct material. This thin film structure provides the necessary structural support while maintaining flexibility, allowing the material to be maintained at the desired location and conform to the tissue geometry

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The biologic material is combined with the adjunct material in a single integrated structure. The adjunct material provides structural support and location stability, while the biologic material promotes tissue adhesion. This merging allows both materials to work together synergistically while solving the location control and structural support issues

Inventive Principle:
Principle #5Merging (Combining)

3Reliability

If biologic materials are used for tissue stapling, then tissue adhesion is promoted, but manufacturing to desired shape and thickness is difficult

Engineering Contradiction:
Improvetissue adhesion promotionVSAvoidshape and thickness control
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The biologic material is applied as a coating or layer on the adjunct material, allowing control of thickness as a parameter. The coating process enables precise control of material thickness and uniformity, solving the manufacturing difficulty while maintaining the tissue adhesion promotion function

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The adjunct material serves as a template or mold that defines the desired shape and thickness. The biologic material is deposited onto this template, copying its geometry and achieving the desired shape and thickness through the manufacturing process

Inventive Principle:
Principle #26Copying

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 natural tissue characteristics, and promotes healing by using biocompatible materials and medicants that induce tissue adhesions and enhance tissue growth.

Implementation Method 1

The at least one medicant is effective to induce tissue adhesions adjacent to the at least one line of deployed staples

Methodology Applied
Scientific EffectTissue adhesion: Adhesive

Implementation Method 2

The effective amount of at least one medicant is disposed within and releasable from the adjunct material

Methodology Applied
Scientific EffectDiffusion: Diffusion

Data Source

PatentUS11129612B2Inducing tissue adhesions using surgical adjuncts and medicants
Publication Date: 2021.09.28 CILAG GMBH INTERNATIONAL
  • US11129612B2 patent drawing
  • US11129612B2 patent drawing
  • US11129612B2 patent drawing

AI summary

Tissue adhesions using surgical adjuncts and medicants are provided. In general, an implantable adjunct can have one or more medicants releasably retained therein that are configured to induce tissue adhesions. The adjunct can be configured to be applied to lung tissue in conjunction with surgical staples using a surgical stapler. Pleurodesis can be encouraged through delivery of the adjunct to the lung tissue.