Custom Bone Substitute Production via Stereolithography Molds

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Solution Overview

Problem

Current methods for producing bone substitutes lack standardization and fail to create bioactive, biomimetic materials that accurately replicate the morphological, physical, and mechanical characteristics of natural bone, making it difficult to achieve both functional and aesthetic reconstruction of bone defects.

Innovation Solution

A method involving reverse engineering of clinical images to create virtual models, followed by stereolithography for producing molds and selecting bioactive, biomimetic materials like natural polymers, ceramics, and composites, which are processed using techniques such as sintering and freeze-drying to achieve precise, porous structures that mimic natural bone.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If direct photopolymerization method is used to produce bone substitutes, then manufacturing speed and customization are improved, but bioactivity and biomimetic properties deteriorate

Engineering Contradiction:
Improvemanufacturing speedVSAvoidbioactivity
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent introduces an indirect two-step production method where a polymeric mold serves as an intermediary. First, a custom-fit polymeric mold is created using rapid prototyping from patient-specific imaging data. Second, bioactive ceramic materials are shaped within this mold through techniques like slip casting or injection molding. This intermediary mold approach enables both customization and bioactivity, resolving the contradiction between manufacturing speed and bioactive material properties.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of manufacture

If acrylic or vinyl resins are used for rapid prototyping of bone substitutes, then ease of manufacture is improved, but biocompatibility and structural similarity to natural bone deteriorate

Engineering Contradiction:
Improveease of photopolymerizationVSAvoidbiocompatibility
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent changes the material parameter from photopolymerizable acrylic/vinyl resins to bioactive ceramic materials (such as hydroxyapatite, tricalcium phosphate, or biphasic calcium phosphate). These ceramic materials are processed using alternative methods like slip casting, injection molding, or extrusion within a polymeric mold, rather than direct photopolymerization. This parameter change ensures biocompatibility and structural similarity to natural bone while maintaining ease of manufacture through the standardized two-step process.

Inventive Principle:
Principle #35Parameter changes

3Adaptability or versatility

If custom-made bone substitutes are produced to fit specific defects, then adaptability is improved, but standardization and process consistency deteriorate

Engineering Contradiction:
Improvecustomization to defect shapeVSAvoidlack of standardized process
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent segments the bone substitute production process into two independent, standardized modules: (1) creation of a patient-specific polymeric mold using rapid prototyping from imaging data, and (2) formation of bioactive ceramic material within the mold using standardized ceramic processing techniques. This segmentation allows each module to be optimized and standardized independently, enabling adaptability to various defect shapes while maintaining process consistency through repeatable standardized procedures for each module.

Inventive Principle:
Principle #1Segmentation

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

Enables the production of custom-made bone substitutes that accurately fit anatomical defects, exhibit necessary porosity for cellular integration, and are bioactive and biomimetic, overcoming the limitations of existing methods by using materials that closely resemble natural tissues.

Implementation Method 1

a made-to-measure bone substitute can be obtained by way of a first 'direct' method, i.e. by way of photopolymerization of the bone defect in a suitable material using a machine for rapid prototyping (stereolithography, STL)

Methodology Applied
Scientific EffectPhotopolymerization: Photopolymerisation

Implementation Method 2

which are processed using techniques such as sintering and freeze-drying to achieve precise, porous structures that mimic natural bone

Methodology Applied
Scientific EffectSintering: Sintering

Implementation Method 3

which are processed using techniques such as sintering and freeze-drying to achieve precise, porous structures that mimic natural bone

Methodology Applied
Scientific EffectFreeze-drying: Freeze Drying

Data Source

PatentEP2481554B1Method for producing bone substitutes and/or fillers made to measure and made of bioactive and biomimetic materials
Publication Date: 2015.12.16 GHIMAS SPA
  • EP2481554B1 patent drawing

AI summary

A method for producing bone substitutes and/or fillers made to measure and made of bioactive and biomimetic materials, and to the bone substitute and/or filler obtainable with such method, comprising the steps of: - receiving clinical images of the bone defect from a clinical unit, - processing the received image in order to obtain a virtual prototype of a female mold part and male mold part of the bone defect, - converting the virtual prototype into a format which is compatible with a rapid prototyping machine, - selecting a material of which the female mold part and the male mold part are to be made, in order to provide female mold parts and male mold parts made of different materials depending on the type of production method used to obtain the bone substitute, - providing the female mold part and the male mold part by way of the rapid prototyping machine, - selecting a material of which the bone filler or substitute is to be made, - providing the bone filler or substitute.