3D Compressible Adjunct for Surgical Stapler Sealing

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Surgical staplers face challenges in achieving consistent sealing due to varying tissue thickness, leading to potential leakage and tissue tearing, as staples lack the natural flexibility and adaptability to intra-tissue pressures.

Innovation Solution

A three-dimensional compressible adjunct made from a bioabsorbable polymer matrix is integrated with surgical staplers, providing a variable stiffness profile that applies a minimum stress threshold of 29 kPa for at least 3 days, compensating for tissue thickness variations and promoting tissue ingrowth.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If staples are used to close tissue openings, then tissue sealing is achieved, but consistent sealing cannot be achieved when tissue thickness varies

Engineering Contradiction:
Improvesealing consistencyVSAvoidtissue thickness adaptation
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The adjunct is designed with varying thickness (e.g., thicker in central regions, thinner at edges) to provide different levels of compression and support at different locations within the stapled tissue, ensuring consistent sealing across varying tissue thicknesses

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The compressible adjunct is pre-installed in the stapler cartridge before surgery, positioned to be compressed between the anvil and staple cartridge during firing, thereby pre-preparing the compression force needed to achieve consistent sealing regardless of tissue thickness variations

Inventive Principle:
Principle #10Preliminary action

2Strength

If rigid staples and adjuncts are used to provide structural support, then sealing force is maintained, but tissue flexibility and ability to withstand varying intra-tissue pressures are lost

Engineering Contradiction:
Improvesealing forceVSAvoidtissue flexibility
Core Design Contradiction:
StrengthVSAdaptability or versatility

Solution Approach 1:

The adjunct is constructed from flexible, compressible materials (such as foam or porous polymers) that can deform and adapt to varying intra-tissue pressures while maintaining sealing force, rather than using rigid structures that would resist such pressure variations

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The adjunct material properties are specifically selected to change under compression - becoming denser and more rigid under high pressure to maintain sealing, while remaining compliant and flexible under normal physiological conditions to accommodate tissue movement and pressure variations

Inventive Principle:
Principle #35Parameter changes

3Reliability

If compression force is applied to ensure sealing, then leakage is prevented, but excessive compression can cause tissue tearing

Engineering Contradiction:
Improvesealing integrityVSAvoidtissue damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The compressible adjunct acts as a cushioning element that distributes compression forces evenly across the stapled tissue, preventing localized excessive pressure that could cause tearing while maintaining sufficient overall compression for sealing

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

Solution Approach 2:

The adjunct utilizes porous or foam materials that can compress gradually and reversibly, allowing controlled deformation under pressure to achieve sealing without transmitting excessive point loads to the tissue that would cause tearing

Inventive Principle:
Principle #31Porous 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 adjunct ensures consistent tissue compression and minimizes leakage and tearing by adapting to varying tissue pressures, while promoting healing and reducing the risk of rejection by facilitating tissue integration.

Implementation Method 1

formed from a matrix that includes at least one fused bioabsorbable polymer

Methodology Applied
Scientific EffectBioabsorption: Absorption (physical)

Implementation Method 2

facilitating tissue integration

Methodology Applied
Scientific EffectBiodegradation: Decomposition (biological)

Implementation Method 3

configured to apply a stress at or above a minimum stress threshold to the tissue

Methodology Applied
Scientific EffectMechanical compression: Compression

Implementation Method 4

formed from a matrix that includes at least one fused bioabsorbable polymer

Methodology Applied
Scientific EffectMaterial strength:

Data Source

PatentEP3530208B1Stapling assembly with three dimensional adjunct
Publication Date: 2023.07.12 ETHICON INC
  • EP3530208B1 patent drawingFigure 1
  • EP3530208B1 patent drawingFigure 2~3
  • EP3530208B1 patent drawingFigure 4~5

AI summary

Stapling assemblies for use with a surgical stapler and methods for manufacturing the same are provided. Three dimensional adjuncts for use with a surgical stapling assembly and methods for manufacturing the same are also provided.