Low Profile Surgical Staple with Continuous Bridge for Bone Fixation
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Solution Overview
Problem
Existing low-profile surgical staples face challenges in achieving high sustained compression and minimizing localized strain concentrations, which can lead to fatigue failure.
Innovation Solution
The development of a low-profile surgical staple with a bridge having a substantially continuous cross-section and legs that form an angle greater than 20 degrees, featuring a wedge-shaped tip, teeth cut into the legs, and a nitinol material, designed to distribute strain evenly and reduce stress concentrations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Shape
If a low-profile staple design is used to minimize the rise above bone surface, then the profile height is reduced, but the stored strain and compression capacity are limited
Solution Approach 1:
The bridge of the staple is designed with a curved configuration having a specific radius of curvature. This curvature allows the bridge to store elastic strain energy while maintaining a low profile when deployed on the bone surface. The curved geometry enables the bridge to flex and store energy without requiring excessive height, resolving the contradiction between low profile and sufficient stored strain.
2Shape
If the bridge cross-section is reduced to lower the profile, then the staple height is minimized, but localized strain concentrations increase at corners
Solution Approach 1:
The cross-section of the bridge is optimized with specific thickness and width dimensions (e.g., thickness of 0.5-1.5mm, width 2-5 times the thickness). This local geometric optimization ensures sufficient structural strength and uniform strain distribution throughout the bridge, preventing localized stress concentrations that would lead to fatigue failure, while maintaining the overall low profile of the staple.
Solution Approach 2:
The bridge incorporates rounded corners and continuous curved transitions rather than sharp angles. This curvature eliminates stress concentration points at corners, improving fatigue resistance and reliability while maintaining the low-profile design through optimized cross-sectional geometry.
3Force
If the leg angle is increased to improve compression, then the compression force increases, but the staple profile height increases
Solution Approach 1:
The legs are designed with curved configurations and optimized angles (e.g., 30-60 degrees relative to the bridge axis) that allow them to generate sufficient compression force on the bone segments while maintaining a compact profile. The curved geometry enables the legs to flex and store energy efficiently without requiring excessive height, resolving the contradiction between compression force and profile height.
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 staple achieves high sustained compression and improved fatigue performance by distributing strain evenly and minimizing localized strain concentrations, resulting in a lower profile design with increased durability and effectiveness in bone healing.
Implementation Method 1
staples can compress bone segments together based on stored strain profiles of the staples
Implementation Method 2
each distal end includes a wedge-shaped tip
Data Source
AI summary
According to particular embodiments, the present staple includes a low-profile bridge and has the capacity for high sustained compression. In some embodiments, the staple includes a bridge with a continuous cross-section, legs with teeth cut therein (e.g., opposed to protruding from, as discussed herein), and legs including an angle of about 24 degrees.