Fibular Fracture Staple with Nitinol Bridge for Low-Profile Fixation
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Solution Overview
Problem
Current methods for fibular fracture fixation, such as metal plates or screws, often result in excessive bulk that inhibits normal ankle function and may lead to localized strain concentrations, increasing the risk of fatigue failure and talar shift, while existing staples have limited compression capacity and profile constraints.
Innovation Solution
A fibular fracture staple with a low-profile design that deforms from a relaxed to an active position, distributing stress across a bridge with multiplanar angles and torsion, providing high sustained compression and minimizing strain concentrations, utilizing Nitinol for its shape memory and superelastic properties to ensure secure closure and reduced risk of trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If metal plates or screws are used for fibular fracture fixation, then fracture stability is improved, but device bulk increases and ankle function is inhibited
Solution Approach 1:
The fixation device is divided into multiple legs (typically four legs) that are inserted into separate bone segments, with a bridge connecting them. This segmentation allows the device to span the fracture site and secure multiple bone fragments independently, providing stable fixation while maintaining a low overall profile that does not interfere with ankle function.
Solution Approach 2:
The staple legs are designed to be inserted into the bone and nested within the bone structure, with the bridge connecting the legs externally. This nesting approach allows the fixation device to be embedded within the bone anatomy rather than spanning externally, significantly reducing the device bulk and avoiding interference with soft tissue and joint function.
2Reliability
If metal plates or screws are used for fibular fracture fixation, then fracture stability is improved, but strain concentrations increase leading to fatigue failure risk
Solution Approach 1:
The bridge connecting the staple legs is designed with varying thickness and geometry to optimize stress distribution. The bridge typically features a thicker central region that tapers toward the ends, creating local quality variations that concentrate structural strength where needed while distributing stresses evenly across the fracture site, thereby preventing strain concentrations and improving fatigue resistance.
3Volume of moving object
If existing staples are used for fibular fracture fixation, then device profile is reduced, but compression capacity is limited
Solution Approach 1:
The staple is constructed from Nitinol, a composite material combining nickel and titanium with specific alloying elements. This composite material provides both the low profile required for minimal soft tissue interference and the high compression capacity needed for effective fracture fixation, resolving the contradiction between device size and mechanical performance.
Solution Approach 2:
The staple utilizes the temperature-dependent phase transformation properties of Nitinol, changing from austenite to martensite phase at body temperature. This parameter change enables the staple to transform from a compressed delivery state to an expanded functional state, providing high compression capacity while maintaining a low profile during delivery and achieving maximum compression force once deployed at the fracture site.
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, improved fatigue performance, and reduced risk of breakage, promoting optimal healing and weight-bearing stability by distributing stress evenly and reducing localized strain concentrations.
Implementation Method 1
utilizing Nitinol for its shape memory and superelastic properties
Implementation Method 2
utilizing Nitinol for its shape memory and superelastic properties
Data Source
AI summary
The present disclosure relates to a staple including a first leg and a second leg connected to a bridge at a first end and a third leg and a fourth leg that are connected to the bridge in line along a central axis spanning a length of the bridge between the first leg and the second leg. In some embodiments, the first leg and the second leg are substantially parallel with one another at the first end. According to particular embodiments, the staple is configured to provide multi-planer forces as the staple attempts to return to a relaxed position from a deformed position. Such multi-planer forces may align or compress two or more bone fragments. The staple may also include a hole and/or a notch for receiving or connecting with a faster.