Stretchable Buttress Assembly for Surgical Stapler Tissue Reinforcement

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Solution Overview

Problem

Surgical stapling instruments often face issues with staples pulling through tissue or tearing, particularly at the site of application, due to lack of reinforcement, which can lead to complications and reduced effectiveness in sealing and closing tissues.

Innovation Solution

The integration of a buttress material with a strong yet flexible composition, such as woven mesh, into the surgical stapler's end effector, which provides structural support and adheres to the tissue via an adhesive, preventing staple pull-through and reducing tissue tearing, while also being stretchable to accommodate tissue expansion and contraction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If staples are applied directly to tissue without reinforcement, then the stapling process is simple and quick, but the staples may pull through tissue or cause tearing

Engineering Contradiction:
Improvestaple holding strengthVSAvoidstapler structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies a buttress material with composite structure consisting of a fabric layer and an adhesive layer. The fabric layer provides mechanical reinforcement to prevent staple pull-through and tissue tearing, while the adhesive layer ensures secure bonding between the buttress material and tissue. This composite material approach resolves the contradiction by enhancing staple holding strength without significantly complicating the stapler device structure.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The buttress material is pre-applied to the tissue surface before stapling occurs. This preliminary action ensures that the reinforcement is already in place when staples are driven through the tissue, preventing pull-through and tearing from the outset. The adhesive layer is activated to bond the buttress material to the tissue prior to stapling, ensuring proper positioning and effectiveness.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If a rigid reinforcement material is used, then staple pull-through is prevented, but the material cannot accommodate tissue expansion and contraction

Engineering Contradiction:
Improveprevention of staple pull-throughVSAvoidaccommodation of tissue movement
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The buttress material employs a flexible fabric layer instead of rigid reinforcement. This fabric layer provides sufficient mechanical strength to prevent staple pull-through and resist tissue tearing while maintaining flexibility to accommodate tissue expansion, contraction, and movement. The thin film structure allows the material to conform to tissue contours and move with the tissue without creating stress concentrations that could lead to failure.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The patent utilizes materials with specific mechanical parameters that balance strength and flexibility. The fabric layer is selected with appropriate tensile strength, elasticity, and tear resistance parameters to prevent staple pull-through while allowing tissue movement. The adhesive layer parameters are optimized to provide strong bonding while maintaining flexibility, ensuring the buttress material remains securely attached to moving tissue.

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If no adhesive is used, then the buttress material can be easily removed, but the material does not adhere to tissue and may shift position

Engineering Contradiction:
Improveremovability of buttress materialVSAvoidposition stability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The adhesive layer is designed with controlled bonding characteristics that provide secure attachment during the surgical procedure while allowing for controlled removal afterward. The adhesive strength is calibrated to prevent premature detachment and position shifting during stapling and tissue manipulation, yet permits clean removal when the surgical procedure is complete. This beforehand cushioning approach ensures proper positioning and effectiveness during surgery while facilitating easy removal when needed.

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

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 use of a buttress assembly with a stretchable, adhesive-backed material enhances the mechanical fastening of staples, reducing the risk of tissue damage and ensuring secure sealing and closure, even in tissues that expand or contract, like a reinflated lung.

Implementation Method 1

an adhesive, configured to adhere the stretchable buttress assembly to an end effector of the surgical stapler

Methodology Applied
Scientific EffectAdhesion: Adhesive

Implementation Method 2

the planar fabric is configured to stretch in one direction

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentEP3162388B1Extensible buttress assembly for surgical stapler
Publication Date: 2020.01.01 ETHICON INC
  • EP3162388B1 patent drawingFigure 1
  • EP3162388B1 patent drawingFigure 2
  • EP3162388B1 patent drawingFigure 3

AI summary

A stretchable buttress assembly is associated with surgical staples deployable into tissue from a surgical stapler having a longitudinal axis. The buttress assembly includes a planar fabric and a bioabsorbable adhesive. The planar fabric also has fibers that are either substantially unaligned with the longitudinal axis of the surgical stapler or substantially aligned with the longitudinal axis of the surgical stapler. The bioabsorbable adhesive is applied to the first side and/or the second side of the planar fabric and is configured to adhere the stretchable buttress assembly to an end effector of the surgical stapler. The buttress assembly is substantially stretchable in one direction. In some versions the buttress assembly is stretchable in a direction parallel to the longitudinal axis. In some versions the buttress assembly is stretchable in a direction perpendicular to the longitudinal axis.