Compressible Knitted Adjuncts 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 often require different staple heights and lack the natural flexibility of tissue, making it difficult to withstand intra-tissue pressures.

Innovation Solution

A compressible knitted adjunct is integrated with the staple cartridge, which can adjust to varying tissue thickness and promote tissue ingrowth, ensuring consistent compression and minimizing leakage by being configured to accommodate staples of the same height across different tissue thicknesses.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If staples of the same height are used for all tissue thicknesses, then device complexity is reduced and ease of operation is improved, but sealing reliability deteriorates due to inconsistent staple compression

Engineering Contradiction:
Improveease of operationVSAvoidsealing reliability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

A compressible adjunct is introduced as an intermediary element between the staples and the tissue. This adjunct compresses under the staples to accommodate varying tissue thicknesses, ensuring consistent compression and sealing reliability while allowing the use of staples of uniform height, thereby maintaining ease of operation.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Adaptability or versatility

If staples are used without adjuncts, then device complexity is minimized, but adaptability to varying tissue thickness deteriorates

Engineering Contradiction:
ImproveadaptabilityVSAvoiddevice complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The compressible adjunct serves as a mediator that enables the stapling device to adapt to varying tissue thicknesses. By placing this compliant element between the rigid staples and the soft tissue, the system gains adaptability while the overall device complexity remains manageable due to the simple integration of the adjunct.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The adjunct changes its compression parameter in response to varying tissue thicknesses. This parameter change allows the stapling system to adapt to different tissue conditions without requiring multiple staple heights or complex adjustment mechanisms, thus improving adaptability while controlling device complexity.

Inventive Principle:
Principle #35Parameter changes

3Manufacturing precision

If rigid staples are used, then manufacturing precision is improved, but flexibility matching with tissue deteriorates leading to tissue tearing

Engineering Contradiction:
Improvemanufacturing precisionVSAvoidtissue tearing
Core Design Contradiction:
Manufacturing precisionVSObject-affected harmful factors

Solution Approach 1:

The compressible adjunct acts as a protective intermediary between the rigid staples and the soft tissue. It distributes the compression force uniformly across the tissue surface, preventing stress concentration that would cause tissue tearing, while allowing the staples to maintain their precise manufactured dimensions and geometry.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 compressible knitted adjunct allows for effective sealing and tissue integration, reducing leakage and tissue tearing by accommodating varying tissue thicknesses and promoting healing, thus enhancing the structural integrity and aesthetics of the stapled site.

Implementation Method 1

The compressible knitted adjunct of the present application can be configured to compensate for variations in tissue properties, such as variations in tissue thickness

Methodology Applied
Scientific EffectCompression: Compression

Implementation Method 2

an inner-most longitudinal terminal edge bordering a longitudinal slot of the staple cartridge. The knitted adjunct can be configured to promote tissue ingrowth

Methodology Applied
Scientific EffectAbsorption: Absorption (physical)

Data Source

PatentEP4061245B1Compressible knitted adjuncts with surface features
Publication Date: 2024.06.26 CILAG GMBH INTERNATIONAL
  • EP4061245B1 patent drawingFigure 1
  • EP4061245B1 patent drawingFigure 2A~2B
  • EP4061245B1 patent drawingFigure 2C

AI summary

Adjuncts for use with a surgical stapler are provided. In one exemplary embodiment, an adjunct can include a first knitted layer, a second knitted layer, and a plurality of recesses that extend into and defined within the second knitted layer. The plurality of recesses can be arranged in a predefined pattern that coincides with a plurality of attachment features extending outward from a top surface of a cartridge such that each recess of the plurality of recesses is configured to engage with at least a portion of at least one attachment feature to form a friction fit therebetween to thereby retain the adjunct on the cartridge prior to staple deployment. Stapling assemblies for use with a surgical stapler are also provided.