Compressible Non-Fibrous Adjunct for Surgical Stapling

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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 of tissue, necessitating the development of improved instruments and methods that can compensate for these issues.

Innovation Solution

A compressible, bioabsorbable non-fibrous adjunct is integrated into the surgical stapling assembly, which is 3D printed and designed to deform under stress, allowing for consistent tissue compression and ingrowth, thereby addressing the variability in tissue thickness and promoting healing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If staples with fixed height are used, then manufacturing is simple, but they cannot achieve desired fired configuration at all staple sites due to varying tissue thickness

Engineering Contradiction:
Improvestaple manufacturing simplicityVSAvoidsealing consistency
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The staple height parameter is made variable rather than fixed. The adjunct structure allows staples to achieve different effective heights by compressing the adjunct material to varying degrees, enabling consistent sealing across tissue sites with different thicknesses while maintaining simple staple manufacturing.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

A compressible non-fibrous adjunct material is introduced as an intermediary between the staples and tissue. This adjunct compresses under stapling force to accommodate varying tissue thicknesses, allowing fixed-height staples to achieve consistent fired configuration and sealing across different tissue sites.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If staples are used, then sealing function is provided, but they lack natural flexibility and cannot withstand varying intra-tissue pressures

Engineering Contradiction:
Improvesealing functionVSAvoidflexibility to tissue
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The mechanical properties of the sealing structure are changed by introducing a compressible adjunct material with specific elasticity parameters. This material can deform under intra-tissue pressures and return to its original shape, providing flexibility and adaptability that rigid staples lack, thereby preventing tissue tearing and maintaining sealing.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The sealing system becomes a composite structure combining staples with a compressible non-fibrous adjunct material. This composite structure integrates the sealing function of staples with the flexibility and pressure-withstanding capability of the compressible material, creating a more adaptable and reliable sealing system.

Inventive Principle:
Principle #40Composite materials

3Strength

If non-compressible adjuncts are used, then structural integrity is maintained, but they cannot accommodate varying tissue thickness

Engineering Contradiction:
Improvestructural integrityVSAvoidaccommodation of tissue thickness
Core Design Contradiction:
StrengthVSAdaptability or versatility

Solution Approach 1:

The compressibility parameter of the adjunct is optimized to balance structural integrity with adaptability. The non-fibrous compressible material maintains sufficient strength to support the stapling process while being capable of deforming to accommodate varying tissue thicknesses, achieving both structural integrity and adaptability simultaneously.

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 adjunct ensures secure sealing and minimizes leakage and tissue tearing by accommodating varying tissue thickness and promoting tissue ingrowth, enhancing the effectiveness and safety of surgical stapling procedures.

Implementation Method 1

a compressible, bioabsorbable non-fibrous adjunct configured to be releasably retained on the staple cartridge. The compressible non-fibrous adjunct is configured to compress to varying heights to thereby compensate for different tissue thickness

Methodology Applied
Scientific EffectCompression: Compression

Implementation Method 2

the non-fibrous adjunct can be formed from a matrix that includes at least one fused bioabsorbable polymer

Methodology Applied
Scientific EffectBioabsorption: Decomposition (biological)

Data Source

PatentEP3791808B1Compressible non-fibrous adjuncts
Publication Date: 2024.09.25 ETHICON INC
  • EP3791808B1 patent drawingFigure 1
  • EP3791808B1 patent drawingFigure 2A~2B
  • EP3791808B1 patent drawingFigure 2C

AI summary

Stapling assemblies for use with a surgical stapler are provided. In one exemplary embodiment, the stapling assembly includes a cartridge having a plurality of staples disposed therein and a non-fibrous adjunct formed of at least one fused bioabsorbable polymer and configured to be releasably retained on the cartridge. Adjunct systems for use with a surgical stapler are also provided. Surgical end effectors using the stapling assemblies are also provided. Methods for manufacturing stapling assemblies and using the same are also provided.