3D Compressible Adjunct for Surgical Stapler Sealing

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Solution Overview

Problem

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

Innovation Solution

A three-dimensional compressible adjunct formed from a matrix of fused bioabsorbable polymers, with a lattice structure and interconnected struts, is integrated into the surgical stapler to compensate for tissue thickness variations and apply a consistent stress of at least 29 kPa to ensure sealing and minimize tissue damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional staples are used to close tissue openings, then the stapling procedure can be performed, but the staples cannot achieve consistent fired configuration due to varying tissue thickness, leading to poor sealing and potential leakage

Engineering Contradiction:
Improvesealing consistencyVSAvoidadaptation to tissue thickness variation
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent applies parameter changes by using a compressible adjunct that can change its compression state based on tissue thickness. The adjunct transitions from an uncompressed state with greater height to a compressed state, adjusting its mechanical properties to accommodate variations in tissue thickness and ensure consistent staple firing configuration across different tissue depths.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The compressible adjunct introduces dynamics to the otherwise static stapling system. It can dynamically compress between the anvil and the tissue during the stapling process, adapting its height and compression force based on the actual tissue thickness encountered, thereby maintaining reliable sealing across varying tissue conditions.

Inventive Principle:
Principle #15Dynamics

2Strength

If rigid staples and sealing materials are used, then structural support is provided, but they lack natural flexibility to withstand varying intra-tissue pressures, leading to tissue tearing and leakage

Engineering Contradiction:
Improvestructural supportVSAvoidflexibility to intra-tissue pressure
Core Design Contradiction:
StrengthVSAdaptability or versatility

Solution Approach 1:

The patent employs flexible shells and thin films through the use of a compressible adjunct made from flexible materials that can deform under intra-tissue pressures. This adjunct provides structural support while maintaining the flexibility needed to withstand varying physiological pressures without causing tissue tearing or leakage.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The compressible adjunct utilizes composite materials that combine structural integrity with flexibility. These composite materials enable the adjunct to provide necessary structural support while simultaneously adapting to dynamic intra-tissue pressure variations, resolving the contradiction between strength and flexibility.

Inventive Principle:
Principle #40Composite materials

3Reliability

If uniform compression is applied to tissue during stapling, then sealing is achieved, but it fails to account for varying tissue thickness, resulting in inadequate compression at some sites and excessive compression at others

Engineering Contradiction:
Improvesealing efficacyVSAvoidcompression uniformity
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The patent applies local quality by enabling the compressible adjunct to provide localized compression adapted to each specific region's tissue thickness. Different portions of the adjunct can compress to different degrees based on the underlying tissue characteristics, ensuring appropriate compression force is applied locally at each stapling site rather than uniform compression across the entire tissue surface.

Inventive Principle:
Principle #3Local quality

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 effectively maintains a consistent stress on tissue, reducing leakage and tissue tearing, while promoting tissue ingrowth and healing by adapting to varying tissue thickness and pressures, thus enhancing the sealing efficacy of surgical staplers.

Implementation Method 1

The adjunct can be configured to apply a stress of at least about 29 kPa (3 gf/mm2)

Methodology Applied
Scientific EffectCompression: Compression

Implementation Method 2

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

Methodology Applied
Scientific EffectBiodegradation: Decomposition (biological)

Data Source

PatentEP3530209B1Three dimensional adjuncts
Publication Date: 2024.02.21 ETHICON INC
  • EP3530209B1 patent drawingFigure 1
  • EP3530209B1 patent drawingFigure 2~3
  • EP3530209B1 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.