Multi-Layer Nitinol Spring for Bone Stabilization Fatigue Life

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Solution Overview

Problem

Existing bone and joint stabilization devices face challenges in achieving higher ultimate strength and longer cyclic fatigue life, which are essential for maintaining effective compression and range of motion in orthopedic surgeries.

Innovation Solution

The use of a multi-layer spring member made from Nitinol alloy with a plurality of beams arranged in pairs, connected by medial connectors, and anchored by a tooth mechanism within an anchoring head, providing improved fatigue life and strength by allowing individual layers to fail without compromising the device's functionality.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If a one-piece spring member is used, then the device structure is simple, but the cyclic fatigue life and ultimate strength are insufficient

Engineering Contradiction:
Improvespring member structureVSAvoidcyclic fatigue life
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The spring member is divided into multiple layers (first layer, second layer, third layer) instead of using a one-piece structure. Each layer can be independently anchored by teeth, creating modular units that can fail independently without compromising the entire device. This segmentation directly addresses the fatigue life issue by distributing stress and failure points across multiple layers.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent uses a composite construction where multiple spring member layers are combined with anchoring teeth and bone anchors to create a multi-component system. This composite approach allows each component to be optimized for its specific function while working together to achieve superior overall performance in terms of strength and fatigue resistance.

Inventive Principle:
Principle #40Composite materials

2Strength

If the spring member thickness is increased, then the ultimate strength is improved, but the device flexibility and range of motion are reduced

Engineering Contradiction:
Improveultimate strengthVSAvoidanatomical range of motion
Core Design Contradiction:
StrengthVSAdaptability or versatility

Solution Approach 1:

By dividing the spring member into multiple thinner layers rather than using a single thick piece, the device achieves the required strength through the combined effect of multiple layers working together. Each thin layer maintains flexibility while the stack of layers collectively provides the necessary ultimate strength, resolving the contradiction between strength and flexibility.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent transitions from a single-dimensional (one-piece) spring member to a multi-dimensional layered structure. By adding the vertical stacking dimension, the device achieves enhanced strength through layer multiplication while each individual layer remains thin enough to maintain flexibility and accommodate anatomical range of motion.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

3Device complexity

If a single layer spring member is used, then the device complexity is low, but the reliability upon layer failure is compromised

Engineering Contradiction:
Improvespring member configurationVSAvoidfunctionality upon failure
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The spring member system is segmented into multiple independent layers, each capable of being anchored separately. This creates a redundant system where if one layer fails, the other layers remain anchored and continue to provide structural support, ensuring device functionality is maintained despite partial failure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The multi-layer design inherently provides a cushioning effect against complete device failure. By distributing the load and anchoring points across multiple layers, the system is prepared in advance to withstand the failure of individual layers without catastrophic loss of functionality, much like a safety buffer.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

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 configuration significantly enhances the cyclic fatigue life and ultimate strength of the devices, enabling them to maintain compression and allow for full anatomical range of motion while reducing the impact of layer failure, thus improving the durability and effectiveness of bone and joint stabilization systems.

Implementation Method 1

a Nitinol (generally, a NiTi alloy that is superelastic (SE) at human body temperature, i.e., having an Af below about 37° C.) spring member having a plurality of layers of limited thickness

Methodology Applied
Scientific EffectSuperelasticity: Pseudoelasticity

Data Source

PatentUS12004777B2Strength and fatigue life improvements for active bone and joint stabilization devices
Publication Date: 2024.06.11 MEDEON BIODESIGN
  • US12004777B2 patent drawing
  • US12004777B2 patent drawing
  • US12004777B2 patent drawing

AI summary

Bone and joint stabilization devices or systems are described that include multiple-layer bodies. The approach offers dramatically improved fatigue life as compared to one-piece spring members that are otherwise similar or comparable. Coordinated improved-strength anchor embodiments, anchor loading tools and methods of use are also described.