Bioabsorbable Bone Screw with Iron Oxide Nanoparticles for X-ray Detection

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Solution Overview

Problem

Conventional bioabsorbable bone screws made of pure polylactic acid (PLA) are not radiographable under X-ray exposure, making surgical positioning and postoperative degradation evaluation difficult, and the addition of radiopaque materials like barium sulfate and bismuth bromide compromises biocompatibility.

Innovation Solution

A bioabsorbable bone screw composed of polylactic acid and iron oxide nanoparticles, with a cap and screw member containing 0.5 to 40 weight percent of iron oxide nanoparticles, manufactured through injection molding or 3D printing, which is radiographable under X-ray exposure and biodegradable in the body.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Difficulty of detecting and measuring

If radiopaque additives such as barium sulfate and bismuth bromide are added to PLA to improve X-ray detectability, then the bone screw becomes radiographable under X-ray exposure, but the biocompatibility deteriorates due to harmful side effects from released additives

Engineering Contradiction:
ImproveX-ray detectabilityVSAvoidbiocompatibility
Core Design Contradiction:
Difficulty of detecting and measuringVSObject-affected harmful factors

Solution Approach 1:

The patent creates a composite material by incorporating iron oxide nanoparticles into the PLA matrix. This composite approach achieves X-ray detectability through the iron oxide content while maintaining biocompatibility, as iron oxide is naturally occurring and non-toxic unlike barium sulfate or bismuth bromide. The composite structure allows the bone screw to be both radiographable and safe for implantation in human bone.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent changes the type of radiopaque additive from conventional radiopaque materials (barium sulfate, bismuth bromide) to iron oxide nanoparticles. This parameter change in the additive composition maintains the desired X-ray detectability while fundamentally improving biocompatibility. The iron oxide nanoparticles provide sufficient radiopacity at concentrations that do not compromise the biodegradability or biocompatibility of the PLA matrix.

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If pure PLA is used to manufacture bone screws to maintain biocompatibility and biodegradability, then the bone screw can be naturally degraded in the body, but the X-ray detectability deteriorates due to low mass density and electron density

Engineering Contradiction:
ImprovebiocompatibilityVSAvoidX-ray detectability
Core Design Contradiction:
Object-affected harmful factorsVSDifficulty of detecting and measuring

Solution Approach 1:

The patent transforms pure PLA into a composite material by dispersing iron oxide nanoparticles throughout the PLA matrix. This composite structure maintains the biocompatible and biodegradable properties of PLA while adding X-ray detectability through the iron oxide component. The nanoparticle dispersion ensures uniform radiopacity without compromising the material's ability to degrade naturally in the body.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent applies local quality enhancement by concentrating iron oxide nanoparticles in specific regions or at controlled concentrations within the PLA matrix. The cap member and screw member contain 0.5 to 40 weight percent iron oxide nanoparticles, creating localized radiopacity that provides sufficient X-ray detectability while maintaining overall biocompatibility. This localized approach allows optimization of radiopacity in critical areas without uniformly compromising biodegradability throughout the entire implant.

Inventive Principle:
Principle #3Local quality

3Difficulty of detecting and measuring

If iron oxide nanoparticles are added to PLA to achieve X-ray detectability, then the bone screw becomes radiographable, but the manufacturing complexity increases due to the need for nanoparticle mixing and distribution

Engineering Contradiction:
ImproveX-ray detectabilityVSAvoidmanufacturing process
Core Design Contradiction:
Difficulty of detecting and measuringVSDevice complexity

Solution Approach 1:

The patent applies preliminary action by pre-mixing the iron oxide nanoparticles with the PLA material before the injection molding or 3D printing process. The nanoparticles are incorporated into the PLA matrix in advance, creating a homogeneous composite material that can then be directly processed using conventional manufacturing techniques. This preliminary mixing step simplifies the overall manufacturing process compared to attempting to add nanoparticles during or after the forming process.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent changes the manufacturing approach to accommodate nanoparticles by using injection molding or 3D printing processes that can handle nanoparticle-containing materials. These processes allow for controlled heating and mixing that ensures uniform nanoparticle distribution throughout the PLA matrix during the forming process itself, rather than requiring separate mixing steps. The parameter changes in processing temperature and method enable seamless integration of nanoparticle incorporation with the manufacturing process.

Inventive Principle:
Principle #35Parameter changes

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 bone screw is clearly visible under X-ray exposure, allowing for improved surgical positioning and postoperative evaluation, while maintaining biocompatibility and avoiding the need for a second surgery for removal, with enhanced bone healing and integration demonstrated by Micro-CT analysis.

Implementation Method 1

A bioabsorbable bone screw composed of polylactic acid and iron oxide nanoparticles, with a cap and screw member containing 0.5 to 40 weight percent of iron oxide nanoparticles, which is radiographable under X-ray exposure

Methodology Applied
Scientific EffectX-ray absorption: Absorption (EM radiation)

Implementation Method 2

PLA is biodegradable in human body and can be naturally excreted from the body after being decomposing into CO2 and H2O

Methodology Applied
Scientific EffectBiodegradation: Decomposition (biological)

Data Source

PatentUS10507051B2X-ray detectable bioabsorbable bone screw
Publication Date: 2019.12.17 GUIZHOU HEHE MEDICAL EQUIPMENT CO LTD
  • US10507051B2 patent drawing
  • US10507051B2 patent drawing
  • US10507051B2 patent drawing

AI summary

A X-ray detectable bioabsorbable bone screw comprises a light-emitting element, a light-sensing element, a transparent inner encapsulant body, an outer covering body, and two conductive frames on which. An optically reflective surface is in contact and formed between the dome enclosing portion of the transparent inner encapsulant body and the outer encapsulant body. A portion of the light emitted by the light-emitting element is reflected to the light-sensing element through the optically reflective surface, and the other portion of the light emitted from the light-emitting element is directly emitting to the light-sensing element through the transparent inner encapsulant body. The present invention applies the optically reflective surface to minimize the overlapping area between the two conductive frames, and reduces the capacitance value, and increases the CMRR in a manner that the photo coupler of the present invention is able to meet the standard of electrical characteristics as required.