Surgical Staple Line Adjuncts for Tissue Integrity

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Solution Overview

Problem

Surgical staplers often cause tissue tears and inflammation due to the lack of natural tissue characteristics in staples, leading to leaks and inadequate sealing, especially in sensitive tissues like lungs, where maintaining tissue integrity is crucial.

Innovation Solution

The use of adjunct materials, such as biologic and synthetic materials, that are integrated with surgical staplers to reinforce the staple line, absorb fluids, and promote healing, which are designed to remain at the surgical site to reduce trauma and enhance tissue integrity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional staples are used for tissue stapling, then the stapling procedure can be completed, but tissue tears and inflammation occur due to lack of natural tissue characteristics

Engineering Contradiction:
Improvetissue integrityVSAvoidtissue trauma
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies composite materials by combining traditional metal staples with biologic or synthetic adjunct materials that mimic natural tissue characteristics. The adjunct material is positioned between the staple and tissue, creating a composite structure that distributes stress more naturally and reduces tissue trauma while maintaining stapling reliability

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The adjunct material serves as an intermediary between the staple and the tissue. This mediator layer absorbs the mechanical stress and distributes it more evenly across the tissue, preventing the concentration of forces that causes tissue tears and inflammation, while still allowing the staple to secure the tissue effectively

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If staples are ejected directly into tissue, then stapling is efficient, but leaks occur due to tissue tears at staple penetration points

Engineering Contradiction:
Improvestapling efficiencyVSAvoidsealing integrity
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The adjunct material is pre-positioned between the staple and tissue before stapling occurs. This preliminary placement ensures that when the staple penetrates, the adjunct material is already in position to distribute stress and prevent tissue tearing, thereby preventing leaks while maintaining stapling efficiency

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The adjunct material acts as a cushioning layer positioned beforehand between the staple and tissue. This prior cushioning absorbs and distributes the mechanical impact of staple penetration, preventing tissue tears that would lead to leaks, while allowing the stapling procedure to proceed efficiently

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Manufacturing precision

If multiple layers of tissue thickness compensators are used, then tissue thickness compensation is improved, but device complexity increases

Engineering Contradiction:
Improvetissue thickness compensationVSAvoidstaple cartridge structure
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The adjunct material provides local quality enhancement by being positioned specifically at the interface between staple and tissue where thickness compensation is most needed. This localized approach achieves effective tissue thickness compensation without requiring complex multi-layer structures throughout the entire staple cartridge

Inventive Principle:
Principle #3Local quality

Data Source

PatentEP2954855B1Woven and fibrous materials for reinforcing a staple line
Publication Date: 2019.04.17 ETHICON INC
  • EP2954855B1 patent drawingFigure 1
  • EP2954855B1 patent drawingFigure 2
  • EP2954855B1 patent drawingFigure 3

AI summary

Adjunct materials and methods of using adjunct material to reinforce a staple line are provided. In general, an adjunct material can be used to maintain a seal in tissue and can prevent stapled tissue from tearing. In some embodiments, a surgical stapler can include a jaw having an adjunct material associated with the jaw. The adjunct material can be attached to tissue via staples deployed by the stapler. In some embodiments, an adjunct material can be a woven material having a single layer or multiple layers, and each layer can have different mechanical properties. In other embodiments, an adjunct material can have a single layer or multiple layers of nonwoven material, such as suture compressed into a three dimensional structure.