Knitted Tissue Scaffolds for Consistent Surgical 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 existing staples lack the natural flexibility and adaptability to intra-tissue pressures.

Innovation Solution

The development of knitted tissue scaffolds with multiple layers of bioabsorbable fibers, including multifilament and monofilament fibers with different degradation rates and glass transition temperatures, which are integrated into surgical staple cartridges to provide a deformable and compressible interface that adapts to tissue thickness and applies consistent stress.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional staples are used, then the stapling procedure is simple, but the seal consistency deteriorates due to varying tissue thickness

Engineering Contradiction:
Improveseal consistencyVSAvoidadaptability to tissue thickness variation
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The scaffold is designed to be compressible and deformable, allowing it to dynamically adapt its shape and density to match the varying thickness of tissue at different staple sites. This dynamic property enables consistent sealing performance across non-uniform tissue surfaces without requiring multiple staple heights.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The scaffold combines multiple materials with different properties: a first material providing structural support and a second material enhancing flexibility and tissue conformity. This composite structure allows the scaffold to simultaneously maintain its shape for consistent stress application while adapting to tissue thickness variations.

Inventive Principle:
Principle #40Composite materials

2Strength

If rigid implant materials are used, then structural strength is improved, but tissue flexibility and pressure resistance deteriorate

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

Solution Approach 1:

The scaffold employs flexible polymer materials that can deform under intra-tissue pressure while maintaining structural integrity. This flexibility allows the scaffold to withstand physiological pressure variations without causing tissue tearing or leakage, unlike rigid traditional staples.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The scaffold materials are selected with specific mechanical parameters including elastic modulus and yield strength that match tissue properties. This parameter matching enables the scaffold to transition between rigid and flexible states as needed, providing both structural support and pressure adaptability.

Inventive Principle:
Principle #35Parameter changes

3Ease of manufacture

If single-layer scaffold is used, then manufacturing is simpler, but functional performance deteriorates

Engineering Contradiction:
Improvemanufacturing simplicityVSAvoidsealing performance
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The scaffold is divided into multiple functional layers, each performing a specific role: one layer provides structural support while another enhances sealing and tissue conformity. This segmentation allows each layer to be optimized for its specific function while maintaining overall manufacturing feasibility through established multi-layer fabrication techniques.

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 knitted scaffolds ensure a consistent seal across varying tissue thicknesses, reduce tissue tearing, and promote tissue ingrowth, maintaining effective stress application for extended periods, thereby enhancing surgical outcomes.

Implementation Method 1

The method can also include annealing the first and second knitted layers interknitted with the spacer fibers

Methodology Applied
Scientific EffectAnnealing: Annealing

Data Source

PatentUS11708652B2Knitted tissue scaffolds
Publication Date: 2023.07.25 CILAG GMBH INTERNATIONAL
  • US11708652B2 patent drawing
  • US11708652B2 patent drawing
  • US11708652B2 patent drawing

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.