Shape Memory Alloy Bone Fixation Device

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Solution Overview

Problem

Current open reduction and internal fixation techniques for bone fractures are invasive, leading to complications such as excess bleeding, infection, and soft tissue damage, particularly in complex fractures and irregularly shaped bones, requiring extensive time and effort for proper alignment and repair.

Innovation Solution

A method utilizing a flexible internal fixation device made from a shape memory alloy, such as Nickel-Titanium, which is shaped and heat-treated to match the bone's curvature, allowing it to be inserted in a soft state and then hardening within the body to align and fix bone fragments without manual manipulation, thereby reducing the need for extensive surgical intervention.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If traditional open reduction and internal fixation techniques are used, then bone fragments can be aligned and secured, but surgical time increases and tissue damage worsens due to extensive manual manipulation required

Engineering Contradiction:

Improvesurgical timeVSAvoidtissue damage

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The fixation device is pre-shaped to match the specific geometry of the patient's bone using 3D imaging and custom manufacturing. This preliminary customization eliminates the need for extensive intraoperative manipulation and alignment, directly reducing surgical time and tissue damage while ensuring precise fit from implantation

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

Traditional manual mechanical manipulation of bone fragments is replaced by the self-aligning properties of the custom-shaped fixation device. The device's pre-configured geometry automatically guides proper bone fragment alignment upon implantation, substituting complex surgical manipulation with a passive mechanical solution that reduces both time and tissue trauma

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Manufacturing precision

If fixation devices are customized to match irregular bone shapes, then alignment precision improves, but device complexity and manufacturing difficulty increase

Engineering Contradiction:

Improvealignment precisionVSAvoiddevice complexity

Core Design Contradiction:

Manufacturing precisionVSDevice complexity

Solution Approach 1:

The fixation device design transitions from standard geometric parameters to patient-specific anatomical parameters derived from 3D bone imaging. This parameter customization enables precise matching of irregular bone surfaces and fracture patterns, achieving superior alignment precision while the additive manufacturing process handles the complexity automatically

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The fixation device incorporates locally optimized features tailored to specific regions of the patient's bone, such as varying thickness, curvature, and attachment point geometries that match the local anatomy. This localized customization ensures precise fit and alignment at each critical interface without requiring overall device complexity to be excessively high

Inventive Principle:

Principle #3Local quality

3Adaptability or versatility

If standard fixation devices are used, then device availability improves, but adaptability to complex fractures and irregular bones deteriorates

Engineering Contradiction:

Improveadaptability to fracture typesVSAvoidmanufacturing simplicity

Core Design Contradiction:

Adaptability or versatilityVSEase of manufacture

Solution Approach 1:

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The custom fixation device design process creates a universal solution framework that can adapt to any bone type or fracture pattern. By using patient-specific 3D imaging and computational design, the same manufacturing approach produces optimized devices for diverse anatomical variations and fracture complexities, achieving universality through customization rather than standardization

Inventive Principle:

Principle #6Universality (Multi-functionality)

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 approach reduces surgical time, minimizes bleeding and tissue damage, and enhances fracture healing by allowing the fixation device to dynamically align and secure bone fragments, improving the efficiency and safety of the procedure.

Implementation Method 1

A method of open reduction and internal fixation of a fractured bone of a patient using a fixation device formed of a shape memory alloy

Methodology Applied

Scientific EffectShape memory alloy: Shape Memory Alloy

Implementation Method 2

heating the fixation device to a third temperature lower than the first temperature and greater than the second temperature to reduce the bone

Methodology Applied

Scientific EffectThermal heating: Heating

Data Source

PatentUS11439445B2Methods of bone reduction and fixation

Publication Date: 2022.09.13 DYNORIF LLC

AI summary

Provided is a method of open reduction and internal fixation of a bone of a patient using a fixation device. The method includes analyzing the bone to obtain a fracture profile, wherein the fracture profile includes data corresponding to a physical structure of the bone, shaping the fixation device using the data of the fracture profile, heat treating the fixation device by heating the fixation device to a first temperature, cooling the fixation device to a second temperature lower than the first temperature, securing the fixation device to the bone, and heating the fixation device to a third temperature lower than the first temperature and greater than the second temperature to reduce the bone.