Superelastic Nitinol Bone Staple with Flared Shoulders

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Solution Overview

Problem

Current bone staples face issues such as breakage, over-spreading, misalignment, and limited compression in small bone procedures, particularly in foot and hand surgeries, due to suboptimal design and material properties, leading to user error and reduced mechanical stability.

Innovation Solution

A room temperature superelastic Nitinol staple with a unique bridge and shoulder configuration, featuring a serpentine or diamond-shaped profile with flared shoulders and a thickened node, designed to distribute force evenly and prevent failure, along with a companion inserter system for precise placement and potential removal, addressing the limitations of existing staples.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a traditional bone staple design is used, then it provides basic bone fixation function, but it is prone to breakage and over-spreading in small bone procedures

Engineering Contradiction:

Improveresistance to breakage and over-spreadingVSAvoidmechanical strength in small bone procedures

Core Design Contradiction:

ReliabilityVSStrength

Solution Approach 1:

The bridge member incorporates localized thickened areas (nodes) and narrowed areas (fillets/waists) to create varying cross-sectional properties. The nodes provide localized strength reinforcement at critical stress points, while the fillets reduce stress concentration. This non-uniform cross-section optimizes the balance between strength and resistance to over-spreading.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The bridge member features a rounded top surface that can be curved in one or two dimensions, providing a segment of a sphere or toroid shape. This curvature distributes stress more evenly across the bridge structure, reducing stress concentration points and improving resistance to breakage while maintaining flexibility for small bone procedures.

Inventive Principle:

Principle #14Spheroidality (Curvature)

2Stability of the object's composition

If a rigid bridge design is used, then it provides structural stability, but it increases the risk of breakage at the bridge member

Engineering Contradiction:

Improvestructural stabilityVSAvoidresistance to breakage

Core Design Contradiction:

Stability of the object's compositionVSReliability

Solution Approach 1:

The bridge member's cross-sectional parameters are varied along its length, with thickened areas (nodes) providing increased thickness and width at critical locations, and narrowed areas (fillets) providing stress relief. This parameter variation allows the bridge to maintain structural stability while reducing breakage risk through strategic reinforcement and stress distribution.

Inventive Principle:

Principle #35Parameter changes

3Adaptability or versatility

If a perpendicular arrangement of legs and bridge is used, then it provides standard fixation capability, but it lacks stiffness and strength for certain procedures

Engineering Contradiction:

Improveapplicability to various proceduresVSAvoidstiffness and strength

Core Design Contradiction:

Adaptability or versatilityVSStrength

Solution Approach 1:

The staple is constructed from Nitinol, a superelastic alloy combining nickel and titanium, which provides both flexibility and exceptional strength. This material enables the staple to achieve high stiffness and strength while maintaining adaptability for various bone fixation procedures including Lapidus arthrodesis and other small bone procedures.

Inventive Principle:

Principle #40Composite materials

4Strength

If a high-profile staple design is used, then it provides structural support, but it occupies excessive space in small bone procedures

Engineering Contradiction:

Improvestructural supportVSAvoidspace occupation in small bones

Core Design Contradiction:

StrengthVSVolume of moving object

Solution Approach 1:

The bridge member features a rounded top surface that can be curved in one or two dimensions, creating a low-profile design that respects the economy of space in small bone procedures. The curvature allows the bridge to maintain structural support capability while minimizing the vertical profile to contact or closely approach the bone surface.

Inventive Principle:

Principle #17Another dimension (Dimensionality change)

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 new staple design enhances mechanical stability, reduces the risk of breakage, and facilitates efficient and reproducible bone fixation with improved compression capabilities, suitable for small bone procedures, while allowing for easy removal and reduced user error.

Implementation Method 1

room temperature superelastic Nitinol devices

Methodology Applied

Scientific EffectSuperelasticity: Pseudoelasticity

Implementation Method 2

shoulders between the legs and bridge that flares to distribute force unto the underlying bone

Methodology Applied

Scientific EffectForce distribution: Pressure Increase

Data Source

PatentUS11642124B2Reinforced bridge superelastic bone compression staple and inserter system

Publication Date: 2023.05.09 ORTHO SOLUTIONS HLDG LTD

AI summary

The invention is a staple comprising a bridge member having a top surface and an opposing bottom surface defining a thickness between and two lateral edges defining a width therebetween and either the thickness or the width includes a center flared area, such as a “diamond-like” shape meaning that it has a v-shape on opposing lateral edges flanked by opposing fillets to form an inserter mount area and the staple has a pair of legs spaced apart along the axis and each joined at a rounded flared shoulder to the bridge member. In a four-legged version the bridge has a waist.