Surgical Staples With Hardness Variations for Tissue Fastening

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Solution Overview

Problem

Existing surgical staples lack variability in hardness, which can lead to inadequate tissue fastening and increased risk of staple roll during formation.

Innovation Solution

The development of surgical staples with varying hardness zones, specifically a staple base with increased hardness to resist deformation and staple legs with controlled bending properties to ensure proper tissue engagement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If surgical staples are made with uniform hardness, then manufacturing is simple, but tissue fastening is inadequate and staple roll occurs during formation

Engineering Contradiction:

Improvetissue fastening reliabilityVSAvoidstaple structure complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The staple is designed with different hardness values at different locations: the crown and proximal portions are harder to resist deformation and prevent roll, while the distal leg portions are softer to allow controlled bending and deformation during formation. This local differentiation of material properties resolves the contradiction between preventing staple roll and enabling proper tissue engagement.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The staple functions as a composite structure with multiple material zones of varying hardness, combining the benefits of rigidity in the crown for stability and flexibility in the legs for deformation. This composite approach allows the single staple to simultaneously achieve roll prevention and proper tissue fastening.

Inventive Principle:

Principle #40Composite materials

2Reliability

If staple base hardness is increased to resist deformation, then staple roll is prevented, but deformation against anvil becomes inconsistent

Engineering Contradiction:

Improvestaple formation consistencyVSAvoidstaple leg deformability

Core Design Contradiction:

ReliabilityVSStrength

Solution Approach 1:

The hardness gradient is specifically designed so that the crown and proximal portions maintain high hardness for consistent positioning and roll prevention, while the distal leg portions have reduced hardness to allow controlled deformation during anvil contact. This local quality differentiation ensures both formation consistency and adequate deformability.

Inventive Principle:

Principle #3Local quality

3Reliability

If staple legs are made softer to ensure proper tissue engagement, then tissue fastening improves, but staple roll increases during formation

Engineering Contradiction:

Improvetissue engagement qualityVSAvoidstaple formation stability

Core Design Contradiction:

ReliabilityVSStability of the object's composition

Solution Approach 1:

The hardness differentiation creates stable proximal portions for formation consistency and softer distal portions for tissue engagement. The transition zone between these regions provides a gradient that balances stability and deformability, allowing the staple to maintain its position during formation while still deforming adequately to engage tissue.

Inventive Principle:

Principle #3Local quality

Data Source

PatentUS12336713B2Surgical staples comprising hardness variations for improved fastening of tissues

Publication Date: 2025.06.24 CILAG GMBH INTERNATIONAL

AI summary

A surgical staple cartridge is disclosed comprising a plurality of staples removably stored within the surgical staple cartridge. The staples comprise staple legs which extend from a staple base portion. The staple legs comprise staple tips configured to pierce tissue and contact a corresponding forming pocket of an anvil of surgical stapling instrument. The staples further comprise zones having different hardnesses.