Knitted Bioabsorbable Scaffold for Consistent Tissue Sealing

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Solution Overview

Problem

Surgical staplers face challenges in achieving consistent tissue sealing due to varying tissue thickness and lack of natural flexibility, leading to undesirable leakage and tearing at staple sites.

Innovation Solution

A knitted elastically deformable, bioabsorbable composite scaffold is integrated with surgical stapling instruments, featuring a tissue interaction surface and a cartridge deck interaction surface with a variable stiffness profile, using multifilament and monofilament fibers of specific polymers to apply consistent stress and promote tissue ingrowth.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional staples are used for tissue stapling, then the stapling procedure can be performed, but consistent tissue sealing cannot be achieved due to varying tissue thickness

Engineering Contradiction:
Improvetissue sealing consistencyVSAvoidaccommodation of varying tissue thickness
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The scaffold changes its physical parameters (compliance, stiffness) over time through controlled degradation of different fiber components. The multifilament fibers degrade faster to reduce stiffness, while monofilament fibers maintain structural integrity, allowing the scaffold to adapt to varying tissue thicknesses and provide consistent sealing pressure throughout the healing process

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The scaffold uses a composite structure combining multifilament and monofilament fibers with different degradation rates. This composite material design enables the scaffold to provide initial structural support while gradually becoming more compliant, solving the contradiction between needing rigidity for support and compliance for adapting to tissue variations

Inventive Principle:
Principle #40Composite materials

2Strength

If rigid implant materials are used, then structural support is provided, but natural flexibility and ability to withstand varying intra-tissue pressures are lost

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

Solution Approach 1:

The scaffold transitions from a rigid state to a more compliant state over time through controlled degradation. Initially, the scaffold provides strong structural support, then gradually becomes more flexible as the multifilament fibers degrade, allowing it to dynamically adapt to varying intra-tissue pressures while maintaining necessary structural integrity

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The mechanical parameters of the scaffold (stiffness, compliance) change over time as different fiber components degrade at different rates. This temporal parameter change allows the scaffold to provide structural support when needed and flexibility when required, resolving the contradiction between strength and adaptability

Inventive Principle:
Principle #35Parameter changes

3Ease of manufacture

If uniform stiffness scaffold is used, then manufacturing is simplified, but ability to provide variable compliance over time for optimal tissue compression is reduced

Engineering Contradiction:
Improvescaffold fabricationVSAvoidtime-dependent tissue compression
Core Design Contradiction:
Ease of manufactureVSDuration of action of moving object

Solution Approach 1:

The scaffold is segmented into different fiber components (multifilament and monofilament) with distinct degradation characteristics. This segmentation allows each component to serve a specific temporal function - multifilament fibers provide initial support then degrade to allow compliance, while monofilament fibers maintain long-term structural integrity, enabling time-dependent compression without overly complicating manufacturing

Inventive Principle:
Principle #1Segmentation

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 scaffold ensures effective tissue compression and sealing across varying tissue thicknesses, minimizing leakage and promoting healing by applying a consistent stress of at least 29000 N/m² for several days, while facilitating tissue ingrowth and integration.

Implementation Method 1

a knitted elastically deformable, bioabsorbable composite scaffold

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Implementation Method 2

The second polymer fibers can degrade at a rate greater than that of the first polymer fibers

Methodology Applied
Scientific EffectHydrolysis: Hydrolysis

Data Source

PatentEP3530203B1Knitted tissue scaffolds
Publication Date: 2023.09.06 ETHICON INC
  • EP3530203B1 patent drawingFigure 1
  • EP3530203B1 patent drawingFigure 2~3
  • EP3530203B1 patent drawingFigure 4~5

AI summary

Staple cartridge assemblies for use with surgical stapling instruments and methods for manufacturing the same are provided. Scaffolds for use with a surgical staple cartridge and methods for manufacturing the same are also provided.