Polymer Composite Cranial Prostheses for Radiolucent Implants

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Solution Overview

Problem

Current medical implants for orthopaedic applications face challenges such as biocompatibility issues, tribological problems, and limited antibacterial properties, particularly in craniomaxillofacial applications where cosmesis and revision surgery complexities are concerns.

Innovation Solution

A composite material comprising a polymeric matrix with a TiO2-reduced graphene oxide nanocomposite is developed, which provides enhanced antibacterial, mechanical, and tribological properties through photocatalytic activity and superhydrophilicity, suitable for use in orthopaedic implants like cranial prostheses, and can be manufactured using 3D printing methods to reduce post-operative imaging artefacts.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If titanium is used for orthopaedic implants, then mechanical strength and biocompatibility are improved, but postoperative CT and MRI scan artefacts are produced which can render imaging impractical

Engineering Contradiction:
Improvemechanical strengthVSAvoidpostoperative imaging quality
Core Design Contradiction:
StrengthVSDifficulty of detecting and measuring

Solution Approach 1:

The patent employs a composite material system consisting of a polymeric matrix (such as PEEK or PPSU) reinforced with ceramic particles (such as hydroxyapatite or alumina) and potentially metallic fibers. This composite approach allows the material to achieve the necessary mechanical strength through the reinforcement phase while the polymeric matrix remains radiolucent, eliminating CT and MRI artefacts and enabling clear postoperative imaging.

Inventive Principle:
Principle #40Composite materials

2Ease of manufacture

If UHMWPE and acrylic are used for orthopaedic implants, then ease of manufacture is improved, but the materials are non-steam sterilisable due to risk of material degradation at required temperatures

Engineering Contradiction:
Improvemanufacturing simplicityVSAvoidsterilization capability
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent modifies the thermal and mechanical parameters of polymeric materials through the addition of ceramic reinforcements and cross-linking mechanisms. The composite structure increases the thermal stability and glass transition temperature of the base polymer, enabling these materials to withstand autoclave sterilization temperatures (121-134°C) without degradation, while maintaining their manufacturing advantages through processes like injection molding and 3D printing.

Inventive Principle:
Principle #35Parameter changes

3Ease of manufacture

If acrylic is used for cranial prostheses, then ease of manufacture is improved, but a relatively high post-surgical infection rate is observed

Engineering Contradiction:
Improvemanufacturing simplicityVSAvoidpost-surgical infection rate
Core Design Contradiction:
Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The patent incorporates silver nanoparticles or silver-coated ceramic particles as antimicrobial agents within the acrylic or polymeric matrix. Silver ions released from these particles create a bacteriostatic and bactericidal environment that prevents bacterial adhesion and proliferation on the implant surface, significantly reducing post-surgical infection rates while maintaining the material's ease of manufacture and cosmetic properties.

Inventive Principle:
Principle #38Strong oxidants (Accelerated oxidation)

4Ease of manufacture

If PEEK is used for orthopaedic implants, then ease of manufacture and radiolucency are improved, but the material has relatively low toughness compared to similar materials

Engineering Contradiction:
Improvemanufacturing easeVSAvoidtoughness
Core Design Contradiction:
Ease of manufactureVSStrength

Solution Approach 1:

The patent creates a composite material system where PEEK serves as the continuous polymeric matrix and is reinforced with high-strength ceramic particles (such as hydroxyapatite, alumina, or zirconia) or metallic fibers. This composite structure combines the radiolucency and manufacturing ease of PEEK with the enhanced toughness and mechanical strength provided by the reinforcement phase, achieving a balanced performance suitable for orthopaedic applications.

Inventive Principle:
Principle #40Composite materials

5Reliability

If HAP is used for orthopaedic implants, then osseointegration is promoted, but the material is expensive, brittle with poor malleability, and has relatively low strength resulting in risk of implant collapse

Engineering Contradiction:
Improveosseointegration promotionVSAvoidmechanical strength
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The patent applies hydroxyapatite (HAP) in a localized manner within the composite structure, such as coating the surface of the implant or distributing HAP particles primarily in regions where osseointegration is most beneficial (e.g., bone-contacting surfaces). The bulk of the implant maintains a stronger matrix material (such as PEEK, titanium alloy, or cobalt-chromium) to provide overall structural integrity and prevent collapse, while the localized HAP regions promote bone bonding without compromising mechanical strength.

Inventive Principle:
Principle #3Local quality

6Object-affected harmful factors

If surface coating with TiO2 is applied to devices, then antibacterial properties are improved, but additional manufacturing stages are required and adequate attachment of the coating is challenging

Engineering Contradiction:
Improveantibacterial propertiesVSAvoidmanufacturing complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent combines the TiO2 photocatalytic antibacterial layer with the structural coating or surface treatment layer in a single integrated coating process. The TiO2 particles are incorporated into a polymer or ceramic coating matrix that is applied directly to the implant surface, eliminating the need for separate antibacterial coating steps. This merged approach reduces manufacturing complexity while ensuring adequate attachment of the TiO2-containing coating through proven adhesion mechanisms.

Inventive Principle:
Principle #5Merging (Combining)

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 composite material offers improved antibacterial efficacy, reduced wear and particulate formation, and enhanced cosmesis in craniomaxillofacial surgeries, along with easier revision surgery access, while maintaining mechanical strength and promoting osseointegration.

Implementation Method 1

TiO2 is known to be a photocatalytic material that is nontoxic, and generally chemically stable

Methodology Applied
Scientific EffectPhotocatalysis: Catalysis

Implementation Method 2

loading of TiO2 was not always effective for bacterial growth inhibition without UV-irradiation

Methodology Applied
Scientific EffectPhoto-oxidation: Photo-oxidation

Implementation Method 3

provides enhanced antibacterial, mechanical, and tribological properties through photocatalytic activity and superhydrophilicity

Methodology Applied
Scientific EffectSuperhydrophilicity: Superhydrophilicity

Data Source

PatentEP3735277B1Medical materials and devices
Publication Date: 2023.11.15 COPE AIDEN
  • EP3735277B1 patent drawingFigure 1~2
  • EP3735277B1 patent drawingFigure 3~4
  • EP3735277B1 patent drawingFigure 5

AI summary

Provided herein is a composite material for use in orthopaedic applications, and an orthopaedic implant made from such material, the composite material comprising a polymeric matrix material and further comprising a filler material comprising TiCte and reduced graphene oxide. Also provided herein is a cranial prosthesis comprising a peripheral frame portion defining an aperture, and a removable insert portion for closing the aperture. Further provided is a cranial prosthesis comprising a core layer and a first skin layer, the first skin layer having a lower porosity than the core layer. The medical materials and devices disclosed herein may provide improved materials for use in orthopaedic applications, prostheses which offer improved access for revision surgery, and prostheses which offer improved bone integration and mechanical properties.