Surgical Stapler Cartridge with Adjustable Anvil Depth

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Solution Overview

Problem

Current surgical stapling instruments face challenges in efficiently forming staples within a staple cartridge, particularly due to the limitations in staple formation pressure and the need for precise control over staple height and tissue thickness compensation, which can result in incomplete or improperly formed staples.

Innovation Solution

The design incorporates a surgical stapling instrument with a compressible staple cartridge and an anvil that allows for adjustable staple formation by varying the depth of anvil insertion, along with a tissue thickness compensator to accommodate different tissue thicknesses, ensuring consistent staple formation and tissue engagement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If the anvil is inserted deeper to increase staple formation pressure, then staple formation quality improves, but the risk of tissue damage and incomplete staple formation increases

Engineering Contradiction:
Improvestaple formation qualityVSAvoidtissue damage risk
Core Design Contradiction:
Manufacturing precisionVSReliability

Solution Approach 1:

The anvil is designed with movable and adjustable insertion depth relative to the cartridge, allowing dynamic adaptation to different tissue thicknesses. The anvil can be positioned at multiple depths (first, second, and third positions) to optimize staple formation pressure for varying tissue conditions, thereby improving staple formation quality without causing tissue damage.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system changes the physical parameter of anvil insertion depth to control staple formation pressure. By adjusting the anvil position relative to the cartridge, the pressure applied during staple formation can be optimized for different tissue types and thicknesses, resolving the contradiction between achieving high-quality staple formation and avoiding tissue damage.

Inventive Principle:
Principle #35Parameter changes

2Ease of manufacture

If the staple cartridge is designed for fixed staple formation pressure, then manufacturing simplicity is maintained, but adaptability to different tissue thicknesses deteriorates

Engineering Contradiction:
Improvecartridge design simplicityVSAvoidtissue thickness accommodation
Core Design Contradiction:
Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The staple cartridge incorporates an anvil with adjustable insertion depth that can be positioned at multiple predetermined locations. This dynamic adjustment capability allows the same cartridge design to adapt to different tissue thicknesses while maintaining relatively simple manufacturing processes compared to fully customizable systems.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The cartridge design integrates multiple anvil positions and a compressible tissue thickness compensator, enabling a single cartridge type to serve multiple tissue thicknesses and surgical applications. This multi-functionality approach maintains manufacturing efficiency while significantly improving adaptability to varying surgical conditions.

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

3Adaptability or versatility

If the anvil insertion depth is made adjustable to accommodate different tissue thicknesses, then adaptability improves, but device complexity increases

Engineering Contradiction:
Improvetissue thickness compensationVSAvoidanvil positioning mechanism
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The anvil positioning mechanism allows dynamic adjustment between predetermined insertion depths, providing adaptability to different tissue thicknesses. The mechanism is designed to be relatively simple, with the anvil movable along the longitudinal axis to three predetermined positions, balancing adaptability with acceptable device complexity.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

A compressible tissue thickness compensator is introduced as an intermediary element between the anvil and the tissue. This compensator automatically adjusts to accommodate varying tissue thicknesses, reducing the complexity of the anvil positioning mechanism while maintaining high adaptability to different surgical conditions.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Manufacturing precision

If the first clearance path is made longer than the first leg of the fastener, then staple formation control improves, but the risk of staple malformation increases

Engineering Contradiction:
Improvestaple height controlVSAvoidstaple formation reliability
Core Design Contradiction:
Manufacturing precisionVSReliability

Solution Approach 1:

The clearance path length is optimized as a critical parameter to control staple formation. By carefully designing the first clearance path to be longer than the first leg of the fastener while maintaining precise dimensional relationships with other cartridge components, the system achieves reliable staple height control without increasing the risk of staple malformation.

Inventive Principle:
Principle #35Parameter changes

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

This approach enables precise control over staple formation, ensuring consistent staple height and effective tissue fastening, even with varying tissue thicknesses, while minimizing the risk of staple malformation and improving the burst strength of the staple line.

Implementation Method 1

a compressible staple cartridge and an anvil that allows for adjustable staple formation by varying the depth of anvil insertion

Methodology Applied
Scientific EffectCompression: Compression

Implementation Method 2

a tissue thickness compensator to accommodate different tissue thicknesses, ensuring consistent staple formation and tissue engagement

Methodology Applied
Scientific EffectCompression: Compression

Data Source

PatentEP3391831B1Fastener cartridge comprising a tissue thickness compensator including openings therein
Publication Date: 2020.11.25 ETHICON INC
  • EP3391831B1 patent drawingFigure 1
  • EP3391831B1 patent drawingFigure 1A
  • EP3391831B1 patent drawingFigure 1B~1E

AI summary

A fastener cartridge assembly. The fastener cartridge assembly can comprise a cartridge body, a tissue thickness compensator releasably secured relative to the cartridge body, and a fastener removably positioned in a staple cavity of the cartridge body. The tissue thickness compensator can comprise a first clearance aperture extending along a first predefined trajectory and a second clearance aperture extending along a second predefined trajectory. The fastener can comprise a first leg aligned with the first clearance aperture and moveable along the first predefined trajectory, a second leg aligned with the second clearance aperture and moveable along the second predefined trajectory. The first and second predefined trajectories can be parallel.