Multi-Layer Adhesive Buttress for Surgical Stapler

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Solution Overview

Problem

Current surgical staplers lack a reliable mechanism to prevent staples from pulling through tissue and reduce tissue tearing at the site of application, necessitating a reinforcement solution to enhance mechanical fastening and tissue integrity.

Innovation Solution

The integration of a buttress assembly with a strong yet flexible material, such as a woven mesh, applied to the surgical stapler's end effector, featuring an upper and lower adhesive layer to secure the buttress to the anvil and staple cartridge, respectively, providing structural support and reducing tissue damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a single adhesive layer is used to attach the buttress to the tissue, then the device complexity is reduced, but the reliability of preventing staple pull-through and tissue tearing deteriorates

Engineering Contradiction:
Improveprevention of staple pull-through and tissue tearingVSAvoidadhesive layer structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The adhesive system is divided into two distinct layers: a first adhesive layer applied to the tissue surface and a second adhesive layer applied to the buttress. This segmentation allows each layer to perform specific functions - the first layer provides initial bonding to the tissue while the second layer secures the buttress material, collectively preventing staple pull-through and tissue tearing more effectively than a single layer could achieve.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The solution employs composite adhesive structure combining two different adhesive layers with potentially different properties. This composite approach allows optimization of each layer for its specific function - one layer for tissue adhesion and another for buttress attachment - thereby enhancing overall reliability without requiring a single complex multi-functional adhesive material.

Inventive Principle:
Principle #40Composite materials

2Reliability

If the adhesive layers are made highly adhesive to ensure secure attachment, then the reliability of tissue fastening is improved, but the risk of tissue damage during adhesive application increases

Engineering Contradiction:
Improveadhesion strengthVSAvoidtissue damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The adhesive system is divided into two distinct layers: a first adhesive layer applied to the tissue surface and a second adhesive layer applied to the buttress. This segmentation allows each layer to perform specific functions - the first layer provides initial bonding to the tissue while the second layer secures the buttress material, collectively preventing staple pull-through and tissue tearing more effectively than a single layer could achieve.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The adhesive layers are designed with controlled adhesion parameters that provide sufficient bonding strength for secure attachment while maintaining tissue compatibility. By optimizing the adhesive properties of each layer separately, the system achieves reliable fastening without excessive adhesive force that could cause tissue damage during application or removal.

Inventive Principle:
Principle #35Parameter changes

3Strength

If the buttress assembly uses multiple layers and components to enhance reinforcement, then the strength of tissue fastening is improved, but the ease of manufacture deteriorates

Engineering Contradiction:
Improvemechanical fastening strengthVSAvoidassembly construction
Core Design Contradiction:
StrengthVSEase of manufacture

Solution Approach 1:

The buttress assembly is segmented into distinct functional components - the buttress material itself and two separate adhesive layers. This segmentation allows each component to be manufactured and optimized independently, then assembled together to provide enhanced mechanical fastening strength. The modular nature simplifies the manufacturing process compared to creating a single integrated complex structure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The solution employs composite adhesive structure combining two different adhesive layers with potentially different properties. This composite approach allows optimization of each layer for its specific function - one layer for tissue adhesion and another for buttress attachment - thereby enhancing overall reliability without requiring a single complex multi-functional adhesive material.

Inventive Principle:
Principle #40Composite materials

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 buttress assembly effectively prevents staple pull-through and tissue tearing, enhancing the structural integrity of the stapled tissue line while maintaining adhesion under various environmental conditions, including humidity, and facilitating secure attachment during surgical procedures.

Implementation Method 1

an upper adhesive layer and a lower adhesive layer respectively providing for adhesion of the buttress assembly to the anvil and the staple cartridge

Methodology Applied
Scientific EffectAdhesion: Adhesive

Data Source

PatentEP3616627B1Surgical stapler buttress assembly with multi-layer adhesive
Publication Date: 2024.06.26 ETHICON INC
  • EP3616627B1 patent drawingFigure 1
  • EP3616627B1 patent drawingFigure 2
  • EP3616627B1 patent drawingFigure 3

AI summary

A surgical stapler end effector assembly includes a staple cartridge, an end effector, and a buttress assembly. The cartridge included a plurality of staples and a deck. The cartridge is operable to drive the staples through the deck. The anvil includes an underside having a staple forming surface configured to receive staples driven through the deck. The buttress assembly is sized and configured to be coupled with the deck of the staple cartridge or the underside of the anvil. The buttress assembly includes a buttress body, a first adhesive layer, and a second adhesive layer. The first and second adhesive layers are formed of different materials. The first adhesive layer is laid over the buttress body. The second adhesive layer is laid over the first adhesive layer such that the first adhesive layer is interposed between the second adhesive layer and the buttress body.