Bioabsorbable Adhesive Buttress for Surgical Stapler Tissue Reinforcement

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Solution Overview

Problem

Current surgical stapling instruments lack a mechanism to reinforce the mechanical fastening of tissue, leading to potential staple pull-through and tissue tearing at the application site.

Innovation Solution

Incorporating a buttress material with an adhesive layer on the staple cartridge or anvil of the surgical stapler to provide structural support and prevent staple pull-through, while also potentially aiding in hemostasis through hemostatic agents like fibrin.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a surgical stapler is used to fasten tissue, then the tissue can be sealed and cut, but the mechanical fastening may fail with staple pull-through and tissue tearing

Engineering Contradiction:
Improvemechanical fastening reliabilityVSAvoidtissue holding strength
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The patent applies composite materials by combining a bicomponent adhesive system (first component from the adhesive cartridge and second component from the anvil or cartridge) that reacts to form a strong bonding agent. This composite adhesive system provides superior bonding strength to prevent staple pull-through while maintaining tissue integrity, directly resolving the contradiction between mechanical fastening reliability and tissue holding strength.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The adhesive system acts as an intermediary between the staples and the tissue, providing an additional bonding mechanism that enhances the mechanical fastening. The adhesive fills gaps and creates a strong bond between the staple legs and tissue, preventing pull-through without requiring increased staple penetration depth that could damage tissue.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Loss of time

If the incision size is reduced for endoscopic surgery, then post-operative recovery time is reduced, but the precision and control of surgical instruments become more difficult

Engineering Contradiction:
Improvepost-operative recovery timeVSAvoidinstrument positioning precision
Core Design Contradiction:
Loss of timeVSEase of operation

Solution Approach 1:

The surgical instrument incorporates self-positioning features where the adhesive cartridge and anvil automatically align and engage during the stapling process. The cartridge is designed to fit precisely into the anvil with automatic registration features, eliminating the need for complex manual alignment procedures and maintaining ease of operation despite the constrained endoscopic access.

Inventive Principle:
Principle #25Self-service

3Strength

If a buttress material is added to reinforce staple lines, then tissue tearing is prevented, but the device complexity increases

Engineering Contradiction:
Improvestaple line integrityVSAvoidstapler structure complexity
Core Design Contradiction:
StrengthVSDevice complexity

Solution Approach 1:

The patent merges the adhesive delivery system with the existing staple cartridge structure. The adhesive cartridge integrates with the staple cartridge, and the adhesive components are incorporated into the anvil or cartridge body, creating a unified device that provides both mechanical fastening and chemical bonding without requiring separate buttress material application steps or additional complex components.

Inventive Principle:
Principle #5Merging (Combining)

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 assists in reducing bleeding at the surgical site by promoting coagulation.

Implementation Method 1

an adhesive material that adheres the buttress to the surgical stapler

Methodology Applied
Scientific EffectAdhesive bonding: Adhesive

Implementation Method 2

assists in reducing bleeding at the surgical site by promoting coagulation

Methodology Applied
Scientific EffectCoagulation: Coagulation

Data Source

PatentEP3072457B1Biologically derived extracellular matrix with infused viscous absorbable copolymer for releasably attaching a staple buttress to a surgical stapler
Publication Date: 2020.07.08 ETHICON INC
  • EP3072457B1 patent drawingFigure 1
  • EP3072457B1 patent drawingFigure 2
  • EP3072457B1 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 buttress body defines a plurality of cells. The adhesive material comprises a polymer. The polymer is bioabsorbable. A first portion of the adhesive material is located within cells of the plurality of cells. A second portion of the adhesive material is located on the buttress body outside the plurality of cells.