Expandable Tissue Thickness Compensator for Surgical Staplers

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Solution Overview

Problem

Current surgical stapling devices face challenges in effectively compensating for varying tissue thicknesses, which can lead to inconsistent staple formation and reduced efficacy in tissue closure.

Innovation Solution

The development of a surgical stapler with an adjustable anvil and a compressible tissue thickness compensator, which aligns staples within a staple cartridge to accommodate different tissue thicknesses, ensuring consistent staple formation and improved tissue closure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a fixed anvil is used in surgical stapling devices, then the device structure is simple, but it cannot accommodate varying tissue thicknesses leading to inconsistent staple formation

Engineering Contradiction:
Improveability to accommodate varying tissue thicknessesVSAvoiddevice structure complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The anvil is made adjustable with multiple position settings that allow it to move closer to or farther from the staple cartridge. This dynamic adjustment capability enables the anvil to accommodate varying tissue thicknesses while maintaining consistent staple formation, resolving the contradiction between adaptability and structural simplicity.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The anvil adjustment mechanism is segmented into discrete position settings, allowing selective positioning based on tissue thickness requirements. This segmentation provides adaptability for different surgical scenarios while keeping the adjustment mechanism relatively simple and manageable.

Inventive Principle:
Principle #1Segmentation

2Manufacturing precision

If tissue thickness compensation is not implemented, then the device structure remains simple, but staple formation consistency deteriorates across different tissue thicknesses

Engineering Contradiction:
Improvestaple formation consistencyVSAvoidcompensator structure complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

A compressible tissue thickness compensator is introduced as an intermediary element between the anvil and the tissue. This compensator absorbs thickness variations through compression, ensuring consistent staple formation across different tissue thicknesses while adding minimal structural complexity to the overall device.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The compensator material properties are designed to change under compression, allowing it to adapt to different tissue thicknesses. This parameter change approach enables consistent staple formation without requiring complex mechanical adjustment mechanisms.

Inventive Principle:
Principle #35Parameter changes

3Adaptability or versatility

If the anvil is positioned far from the tissue to accommodate thick tissue, then thick tissue can be stapled, but staple formation quality deteriorates for thin tissue

Engineering Contradiction:
Improveability to handle different tissue thicknessesVSAvoidstaple formation quality
Core Design Contradiction:
Adaptability or versatilityVSManufacturing precision

Solution Approach 1:

The adjustable anvil allows dynamic repositioning based on actual tissue thickness encountered during surgery. For thin tissue, the anvil can be positioned closer to maintain optimal staple formation quality, while for thick tissue it can be positioned farther away, thus resolving the contradiction between adaptability and staple quality.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The anvil position can be locally optimized for each specific tissue thickness scenario. This local quality adjustment ensures that staple formation conditions are optimized for the specific tissue being stapled, whether thin or thick, thereby maintaining high staple quality across different tissue types.

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 solution enables consistent staple formation across varying tissue thicknesses, enhancing the efficacy of tissue closure and reducing the risk of tissue damage or incomplete sealing.

Implementation Method 1

a compressible tissue thickness compensator, which aligns staples within a staple cartridge to accommodate different tissue thicknesses

Methodology Applied
Scientific EffectCompression: Compression

Implementation Method 2

The patch may be coated and/or impregnated with materials, such as, precursors, that will form a hydrogel in situ. These hydrogels may further promote hemostasis and/or assist in adhering the patch to tissue.

Methodology Applied
Scientific EffectHydrogel formation: Hydrogel

Data Source

PatentEP2656793B1Expandable tissue thickness compensator
Publication Date: 2021.10.06 CILAG GMBH INTERNATIONAL
  • EP2656793B1 patent drawingFigure 1
  • EP2656793B1 patent drawingFigure 1A
  • EP2656793B1 patent drawingFigure 1B~1E

AI summary

A tissue thickness compensator (70010, 70130, 70150, 70182) may generally comprise a biocompatible material, a first component (70010A), and a second component (70010B), wherein the first component and second component form a reaction product to expand the tissue thickness compensator. The first component may comprise a first hydrogel precursor, the second component may comprise a second hydrogel precursor, and the reaction product may comprise a hydrogel. The reaction product may be formed in vivo and/or in situ by contacting the first component and the second component. The first component and/or second component may be encapsulated and configured to release the components when rupturcd. The reaction product may comprise a fluid-swcllablc composition. Articles of manufacture comprising the tissue thickness compensator and methods of making and using the tissue thickness compensator are also described.