Compressible Tissue Thickness Compensator for Consistent Staple Formation

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Solution Overview

Problem

Current surgical stapling instruments face challenges in consistently forming staples across varying tissue thicknesses, leading to potential malformation and inadequate hemostasis, especially when dealing with tissues of different thicknesses or when staples are improperly formed.

Innovation Solution

The implementation of a compressible tissue thickness compensator integrated with the surgical stapling instrument, which includes a cartridge body made of compressible materials like oxidized regenerated cellulose, bioabsorbable foams, and layers with varying compressibility, allowing the anvil to deform staples within the cartridge body, ensuring consistent staple formation across different tissue thicknesses and providing hemostatic properties.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If a traditional surgical stapling instrument is used, then the structure is simple and easy to manufacture, but the staple formation is inconsistent when dealing with tissues of different thicknesses

Engineering Contradiction:

Improvestaple formation consistencyVSAvoidinstrument structure

Core Design Contradiction:

Manufacturing precisionVSDevice complexity

Solution Approach 1:

The cartridge body is pre-formed with a compressible structure containing hemostatic material before the stapling operation. This preliminary preparation allows the cartridge to automatically adapt to varying tissue thicknesses during stapling, ensuring consistent staple formation without requiring complex real-time adjustment mechanisms.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The cartridge body material properties are designed to change under compression - transitioning from a compressible state during stapling to a more rigid state after compression. This parameter change allows the same structure to accommodate varying tissue thicknesses while maintaining consistent staple formation pressure.

Inventive Principle:

Principle #35Parameter changes

2Adaptability or versatility

If the tissue thickness is varied, then the adaptability to different surgical conditions is improved, but the staple formation consistency deteriorates

Engineering Contradiction:

Improvetissue thickness accommodationVSAvoidstaple formation consistency

Core Design Contradiction:

Adaptability or versatilityVSManufacturing precision

Solution Approach 1:

The cartridge body is designed with non-uniform local properties - the compressible material is distributed throughout the cartridge structure, allowing different regions to compress according to the local tissue thickness. This local quality variation enables the cartridge to adapt to varying tissue conditions while maintaining consistent staple formation through the hemostatic material's uniform distribution.

Inventive Principle:

Principle #3Local quality

3Manufacturing precision

If the anvil applies high compression force, then the staple formation quality is improved, but the tissue damage and hemostasis effectiveness worsen when tissue thickness varies

Engineering Contradiction:

Improvestaple formation qualityVSAvoidtissue damage

Core Design Contradiction:

Manufacturing precisionVSObject-affected harmful factors

Solution Approach 1:

The hemostatic material within the cartridge body serves as a cushioning element that is pre-positioned between the anvil and the tissue. This beforehand cushioning protects the tissue from excessive compression forces by absorbing and distributing the pressure, ensuring adequate staple formation while preventing tissue damage and providing simultaneous hemostasis.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

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 ensures consistent staple formation and enhanced hemostasis by accommodating tissues of varying thicknesses, minimizing staple malformation and promoting effective tissue closure, while the compressible cartridge body remains implanted to support the staple line and potentially deliver therapeutic agents.

Implementation Method 1

a compressible tissue thickness compensator integrated with the surgical stapling instrument, which includes a cartridge body made of compressible materials

Methodology Applied

Scientific EffectCompression: Compression

Implementation Method 2

providing hemostatic properties

Methodology Applied

Scientific EffectAbsorption: Absorption (physical)

Data Source

PatentUS11540824B2Tissue thickness compensator

Publication Date: 2023.01.03 CILAG GMBH INTERNATIONAL

AI summary

In various embodiments, a tissue thickness compensator can comprise one or more capsules and/or pockets comprising at least one medicament therein. In at least one embodiment, staples can be fired through the tissue thickness compensator to rupture the capsules. In certain embodiments, a firing member, or knife, can be advanced through the tissue thickness compensator to rupture the capsules.