Tissue Thickness Compensator for Consistent Staple Formation

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Solution Overview

Problem

Surgical stapling instruments face challenges in consistently forming staples across varying tissue thicknesses, leading to inconsistent staple formation and potential tissue damage.

Innovation Solution

The development of a surgical stapling instrument featuring a tissue thickness compensator, which includes a compressible layer within the staple cartridge that adjusts to different tissue thicknesses, ensuring consistent staple formation and minimizing tissue damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If a fixed anvil surface is used for staple formation, then the device structure is simple, but staple formation becomes inconsistent when tissue thickness varies

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

Solution Approach 1:

The anvil surface is made dynamically adjustable through a mechanism that allows the anvil to move relative to the staple cartridge. This dynamic adjustment enables the anvil surface to adapt to different tissue thicknesses, ensuring consistent staple formation across varying conditions without requiring a completely complex redesigned structure.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The invention changes the positional parameter of the anvil surface relative to the staple cartridge by introducing an adjustable mechanism. This parameter change allows the system to accommodate different tissue thicknesses while maintaining consistent staple formation, resolving the contradiction between precision and complexity.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If the anvil surface is adjusted to accommodate varying tissue thicknesses, then staple formation consistency is improved, but the device complexity increases

Engineering Contradiction:
Improvestapling process reliabilityVSAvoidadjustable anvil mechanism complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The adjustable anvil mechanism introduces dynamic adaptability to the stapling process, allowing real-time adjustment based on tissue thickness. This dynamic feature improves reliability by ensuring consistent staple formation across different tissue conditions while maintaining a relatively streamlined mechanism.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The adjustable anvil mechanism serves multiple functions: it accommodates varying tissue thicknesses, ensures consistent staple formation, and maintains structural integrity. This multi-functionality improves reliability without proportionally increasing device complexity.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Adaptability or versatility

If a rigid staple cartridge is used, then the cartridge structure is simple, but it cannot adapt to different tissue thicknesses leading to inconsistent stapling

Engineering Contradiction:
Improvetissue thickness adaptabilityVSAvoidcartridge structure complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The staple cartridge is designed with dynamic characteristics, allowing it to flex or adjust its position relative to the anvil based on tissue thickness. This dynamic adaptability enables the cartridge to work effectively with varying tissue conditions while maintaining a relatively simple overall structure.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The cartridge incorporates flexible elements that allow it to adapt to different tissue thicknesses. These flexible components enable the cartridge to maintain proper alignment with the anvil surface across varying conditions without requiring a complex adjustable mechanism.

Inventive Principle:
Principle #30Flexible shells and thin films

4Object-affected harmful factors

If the anvil and staple cartridge are fixed relative to each other, then the device structure is simple, but tissue damage occurs due to inconsistent staple formation

Engineering Contradiction:
Improvetissue damageVSAvoidrelative adjustment mechanism complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The relative adjustment mechanism between the anvil and staple cartridge is made dynamic, allowing automatic or manual adjustment to accommodate different tissue thicknesses. This prevents inconsistent staple formation and associated tissue damage while maintaining a relatively simple mechanism.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

An intermediary adjustment mechanism is introduced between the anvil and staple cartridge to mediate their relative positioning. This intermediary component enables fine-tuning of the gap between them, preventing tissue damage from inconsistent staple formation without requiring a completely complex redesign.

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 tissue thickness compensator ensures consistent staple formation across varying tissue thicknesses, reducing the risk of tissue damage and improving the reliability of the stapling process.

Implementation Method 1

a compressible layer within the staple cartridge that adjusts to different tissue thicknesses

Methodology Applied
Scientific EffectCompression: Compression

Data Source

PatentUS10258330B2End effector including an implantable arrangement
Publication Date: 2019.04.16 CILAG GMBH INTERNATIONAL
  • US10258330B2 patent drawing
  • US10258330B2 patent drawing
  • US10258330B2 patent drawing

AI summary

In various embodiments, an end effector comprising a first jaw, a second jaw, an implantable arrangement, first cavities, and second cavities is disclosed. At least one of the first and second jaws is movable to compress tissue between the first jaw and second jaws. The implantable arrangement comprises a first layer and a second layer. The first layer and the second layer comprise a polymeric composition. The first cavities are defined in the first layer and interconnectedly form a permeable first layer. The first cavities releasably retain a first therapeutic agent configured to induce a first biological response in the tissue. The second cavities are defined in the second layer and interconnectedly form a permeable second layer. The second cavities releasably retain a second therapeutic agent configured to induce a second biological response in the tissue. The first therapeutic agent and the second therapeutic agent are different.