Staple Cartridge with Offset Legs and Hardness Zones

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Solution Overview

Problem

Current surgical stapling instruments face challenges in achieving consistent and efficient tissue fastening due to issues with staple roll, rotation, and uneven staple formation, which can lead to inadequate tissue compression and potential complications during surgical procedures.

Innovation Solution

The development of a staple cartridge assembly with various tissue compression gaps and staple forming gaps, featuring staples with unique geometries and materials, such as stainless steel or titanium, that include offset staple legs and varying hardness zones to prevent roll and ensure predictable deformation, along with anvil forming pockets designed to guide staples into optimal configurations.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional staples with uniform geometry are used, then manufacturing is simple, but staple roll and rotation occur leading to inconsistent tissue compression

Engineering Contradiction:
Improvetissue compression consistencyVSAvoidstaple geometry complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The staple is designed with non-uniform geometry including varying leg lengths, offset positions, and different hardness zones along the staple body. This local variation in physical properties prevents uniform deformation during firing, thereby eliminating staple roll and rotation while ensuring consistent tissue compression across the staple row.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The staple incorporates asymmetric features such as offset staple legs where the distal and proximal legs are positioned at different distances from the staple crown centerline. This asymmetry creates predictable deformation patterns during staple formation that counteract rolling and rotating motions, improving reliability of tissue fastening.

Inventive Principle:
Principle #4Asymmetry

2Quantity of substance

If denser staple arrangements are implemented, then tissue fastening coverage improves, but staple formation consistency deteriorates due to increased interference

Engineering Contradiction:
Improvestaple densityVSAvoidstaple formation consistency
Core Design Contradiction:
Quantity of substanceVSManufacturing precision

Solution Approach 1:

By introducing local variations in staple geometry and hardness distribution, each staple deforms in a predictable and controlled manner during formation. This prevents lateral displacement and rotation even when staples are densely packed, maintaining formation consistency despite increased staple density and reduced spacing between adjacent staples.

Inventive Principle:
Principle #3Local quality

3Manufacturing precision

If uniform hardness staples are used, then manufacturing is easier, but predictable deformation during staple formation is reduced

Engineering Contradiction:
Improvestaple deformation predictabilityVSAvoidstaple manufacturing complexity
Core Design Contradiction:
Manufacturing precisionVSEase of manufacture

Solution Approach 1:

The staple incorporates zones with different hardness values along its length, with harder material at the legs and crown for structural integrity and softer material in specific regions to facilitate controlled deformation during forming. This localized hardness variation enables predictable deformation patterns while remaining compatible with standard manufacturing processes.

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

This solution enhances the consistency and efficiency of tissue fastening by minimizing staple roll and rotation, ensuring secure tissue compression and reducing the risk of complications during surgical procedures, while allowing for denser staple arrangements and improved staple guidance.

Implementation Method 1

various tissue compression gaps configured to receive and compress tissue therebetween

Methodology Applied
Scientific EffectCompression: Compression

Implementation Method 2

anvil with staple-forming pockets aligned with the rows of staples in the staple cartridge

Methodology Applied
Scientific EffectPlastic deformation: Plasticity

Data Source

PatentUS12137913B2Staple cartridge assembly comprising various tissue compression gaps and staple forming gaps
Publication Date: 2024.11.12 CILAG GMBH INTERNATIONAL
  • US12137913B2 patent drawing
  • US12137913B2 patent drawing
  • US12137913B2 patent drawing

AI summary

An end effector including an anvil and a staple cartridge assembly is disclosed. The staple cartridge assembly comprises a deck having steps defined thereon for compressing tissue positioned between the anvil and the staple cartridge assembly to different pressures. The staple cartridge assembly further comprises staples having different unformed heights removably stored therein. The staples are deformed against the anvil to different formed heights.