Bioabsorbable Gel Adhesive for Surgical Stapler Buttress

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Solution Overview

Problem

Current surgical stapling instruments lack a mechanism to effectively reinforce the mechanical fastening of tissue provided by staples, leading to potential issues such as staples pulling through the tissue and tissue tearing near the stapled site.

Innovation Solution

Incorporating a buttress material with an adhesive layer into the surgical stapler, which is secured to the staple cartridge or anvil, to provide structural support and prevent staple pull-through, while also reducing tissue tearing and bleeding.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If staples are used to fasten tissue, then the tissue can be mechanically fastened, but the staples may pull through the tissue causing tissue tearing

Engineering Contradiction:
Improvemechanical fastening strengthVSAvoidstaple hold security
Core Design Contradiction:
StrengthVSReliability

Solution Approach 1:

The patent applies composite materials by combining staple material with buttress material that has adhesive properties. The buttress material is applied to the tissue alongside or over the staples, creating a composite fastening system where the mechanical strength of staples is enhanced by the adhesive and structural support of the buttress material, preventing staple pull-through and tissue tearing.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent changes the physical and chemical parameters of the fastening system by introducing buttress material with specific adhesive properties, viscosity characteristics, and structural parameters. This material modifies the interaction between staples and tissue, increasing friction, providing adhesive bonding, and distributing mechanical loads to enhance overall fastening reliability.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If a buttress material with adhesive layer is added to the surgical stapler, then the structural support and prevention of staple pull-through is improved, but the device complexity increases

Engineering Contradiction:
Improvestaple fastening reliabilityVSAvoidstapler structure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies preliminary action by pre-coating the buttress material with an adhesive layer before application to the tissue. This adhesive layer is prepared in advance with appropriate viscosity and bonding characteristics, so that when the buttress material is applied alongside the staples, it immediately provides enhanced adhesion and structural support without requiring additional steps during the stapling process.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The buttress material serves multiple functions simultaneously: it provides structural support to the tissue, enhances adhesive bonding between the stapler components and tissue, prevents staple pull-through, and reduces tissue tearing. This multi-functionality consolidates several protective and supportive roles into a single material component, managing device complexity while improving reliability.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Strength

If the adhesive layer is made highly adhesive to secure the buttress material, then the structural support is improved, but the ease of releasing the buttress material after stapling deteriorates

Engineering Contradiction:
Improveadhesive bonding strengthVSAvoidbuttress material release ease
Core Design Contradiction:
StrengthVSEase of operation

Solution Approach 1:

The patent applies dynamics by designing an adhesive layer with time-dependent and condition-dependent bonding characteristics. The adhesive provides strong initial bonding to secure the buttress material and staples during the stapling procedure, but its bonding strength dynamically changes over time or under specific conditions (such as moisture exposure, enzymatic degradation, or mechanical stress), allowing for controlled release or degradation after the fastening function is fulfilled.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The adhesive layer's parameters such as viscosity, bonding strength, and degradation rate are carefully controlled and changed over time. Initially, the adhesive maintains high bonding strength to secure the buttress material effectively. Over time, through biodegradation, hydrolysis, or other chemical processes, the adhesive parameters change to reduce bonding strength, enabling natural release or removal of the buttress material without manual intervention.

Inventive Principle:
Principle #35Parameter changes

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 material enhances the integrity of the staple line, reduces the risk of tissue tearing, and aids in hemostasis by providing additional structural support and adhesive properties to secure the staples effectively.

Implementation Method 1

Incorporating a buttress material with an adhesive layer into the surgical stapler, which is secured to the staple cartridge or anvil

Methodology Applied
Scientific EffectAdhesive bonding: Adhesive

Data Source

PatentEP3072453B1Naturally derived bioabsorbable polymer gel adhesive for releasably attaching a staple buttress to a surgical stapler
Publication Date: 2020.09.23 ETHICON INC
  • EP3072453B1 patent drawingFigure 1
  • EP3072453B1 patent drawingFigure 2
  • EP3072453B1 patent drawingFigure 3

AI summary

A surgical stapler end effector comprises a staple cartridge, an anvil, and a buttress assembly. The staple cartridge comprises a plurality of staples and a deck. The staple cartridge is operable to drive the staples through the deck. The anvil is movable from an open position toward the staple cartridge to reach a closed position. The anvil includes an underside having staple forming surface configured to receive staples driven through the deck. The buttress assembly comprises a buttress body and an adhesive material. The adhesive material comprises a polymer. The polymer is bioabsorbable. The polymer comprises a gel.