Orthopedic Screw Bioresorbable Layer Rigid Flexible Transition

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Solution Overview

Problem

Current bone fixation technologies face challenges in providing a fixation system that can transition from rigid to flexible osteosynthesis, as existing systems either lack sufficient compression or inhibit micromotion necessary for bone healing, leading to issues like loosening and non-unions.

Innovation Solution

An orthopedic fixation device featuring a screw with a bioresorbable layer that initially fixes the screw at a desired angular position relative to a bone plate or body, allowing angular movement upon resorption, enabling a transition from rigid to flexible osteosynthesis and promoting micromotion for bone healing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a locking screw is used to provide fixed angular relationship and high resistance to shear force, then stability at the bone screw/plate hole interface is improved, but the capability to compress bone fragments is limited and micromotion across the fracture site is impeded

Engineering Contradiction:
Improvestability at bone screw/plate hole interfaceVSAvoidcapability to compress bone fragments and allow micromotion
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The screw/plate connection transitions from a static locked state to a dynamic flexible state. The bioresorbable layer initially provides rigid locking to stabilize the fracture, then progressively degrades to allow controlled micromotion that stimulates callous formation and bone healing.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The mechanical properties of the screw/plate interface change over time through bioresorption of the coating layer. The connection evolves from high rigidity and strength to increased flexibility and micromotion capability, matching the healing process requirements.

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If a non-locking screw is used to allow micromotion and promote callous formation, then flexible osteosynthesis is improved, but resistance to shear force is low leading to loosening

Engineering Contradiction:
Improvemicromotion for callous formationVSAvoidresistance to shear force
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The bioresorbable layer is applied to the screw before implantation to provide immediate locking capability. This preliminary rigid fixation ensures stability during the critical initial healing phase before the layer degrades to allow flexible osteosynthesis.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If rigid osteosynthesis is used to provide stable fixation, then loosening is reduced, but non-unions may occur due to inhibition of micromotion

Engineering Contradiction:
Improvefixation stabilityVSAvoidinhibition of micromotion leading to non-unions
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The fixation system continuously adapts its mechanical properties to match the healing process. The bioresorbable layer maintains rigid fixation during the stabilization phase, then progressively degrades to enable micromotion for callous formation, ensuring continuous useful action throughout the healing timeline.

Inventive Principle:
Principle #20Continuity of useful action

4Ease of operation

If flexible osteosynthesis is used to promote bone healing through micromotion, then callous formation is stimulated, but fixation stability is reduced leading to loosening

Engineering Contradiction:
Improvemicromotion for bone healingVSAvoidfixation stability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The system dynamically transitions from rigid to flexible fixation based on the healing stage. The bioresorbable coating degrades over time, allowing the screw to move from a locked state providing stability to a flexible state enabling micromotion for bone healing.

Inventive Principle:
Principle #15Dynamics

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 device provides stable initial fixation followed by controlled micromotion, enhancing bone healing by allowing the screw to move angularly relative to the body once the bioresorbable layer is resorbed, thus addressing the limitations of both rigid and flexible osteosynthesis systems.

Implementation Method 1

A layer of bioresorbable material is positioned surrounding a second portion of the shaft... The screw is angularly movable with respect to the body upon resorption of at least a portion of the bioresorbable layer

Methodology Applied
Scientific EffectBioresorption: Decomposition (biological)

Data Source

PatentUS11389216B2Orthopedic fixation screw with bioresorbable layer
Publication Date: 2022.07.19 STABILIZ ORTHOPAEDICS LLC
  • US11389216B2 patent drawing
  • US11389216B2 patent drawing
  • US11389216B2 patent drawing

AI summary

The device has a body with holes to accept the bone screws. The bone screws have a layer of bioresorbable material on a surface portion of the head of the screw contiguous with the shaft. Engagement between the bone screws and the body is initially through the bioresorbable material, which engagement rigidly fixes the relative angular orientation between the bone screws and the body when the device is applied to a bone. As the bioresrobable material is resorbed the angular relation between the bone screws and the body is no longer rigidly fixed, thereby effecting a transformation from rigid osteosynthesis to flexible osteosynthesis to allow micromotion between the bone fragments which promotes healing.