Calcium Sulfate Filled Bioceramic Bone Scaffold

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Solution Overview

Problem

Current synthetic bone substitute materials fail to effectively replicate the structure and healing environment of natural cancellous bone, leading to inadequate structural support and improper pacing of the healing process, which can result in reduced performance and increased immunogenic response.

Innovation Solution

A synthetic bone substitute material comprising a reticulated bioceramic framework with a calcium sulfate pore-filling composition, which mimics the pore structure of natural cancellous bone, providing a scaffold for cellular infiltration and tissue ingrowth, while the calcium sulfate enhances stability and resorbs at a controlled rate to facilitate healing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If synthetic bone substitute materials are used to replace natural bone material, then the problems associated with autograft and allograft bone (such as donor site morbidity, immunogenic response, and disease transfer) are avoided, but the structural support and physical structure mimicry of natural cancellous bone are insufficient

Engineering Contradiction:
Improveimmunogenic response and disease transfer riskVSAvoidstructural support capability
Core Design Contradiction:
Object-affected harmful factorsVSStrength

Solution Approach 1:

The patent employs a porous beta-tricalcium phosphate ceramic structure with controlled pore size and interconnectivity that mimics natural cancellous bone architecture. This porous structure provides both structural support and facilitates cellular infiltration, vascular ingrowth, and nutrient transport while maintaining mechanical integrity during the healing process.

Inventive Principle:
Principle #31Porous materials

Solution Approach 2:

The patent creates a composite material system combining beta-tricalcium phosphate ceramic with demineralized bone matrix and growth factors. This composite approach integrates the structural stability of ceramic with the bioactive properties of bone matrix, achieving both mechanical support and biological functionality that neither material could provide alone.

Inventive Principle:
Principle #40Composite materials

2Ease of manufacture

If synthetic bone substitute materials with simplified structure are used, then manufacturing complexity is reduced, but the ability to mimic natural bone density and physical structure is compromised, leading to reduced performance

Engineering Contradiction:
Improvemanufacturing simplicityVSAvoidbone structure mimicry accuracy
Core Design Contradiction:
Ease of manufactureVSManufacturing precision

Solution Approach 1:

The patent utilizes controlled parameter changes during the sintering process, including temperature gradients, holding times, and atmospheric conditions, to achieve precise control over pore size, pore interconnectivity, and overall density of the beta-tricalcium phosphate ceramic. These parameter optimizations enable replication of natural bone's physical characteristics while maintaining manufacturing feasibility.

Inventive Principle:
Principle #35Parameter changes

3Ease of manufacture

If synthetic bone materials with uniform porosity are used, then manufacturing is simplified, but the resorption rate cannot be properly paced to match the natural healing process, failing to provide necessary framework for tissue ingrowth

Engineering Contradiction:
Improveporosity uniformityVSAvoidhealing process pacing
Core Design Contradiction:
Ease of manufactureVSDuration of action of moving object

Solution Approach 1:

The patent implements local quality variations within the bone substitute material by creating regions with different pore sizes, pore interconnectivity, and ceramic density. These localized variations allow different areas to resorb at different rates, providing a staged resorption profile that matches the temporal progression of natural bone healing and tissue ingrowth.

Inventive Principle:
Principle #3Local quality

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 material provides a suitable environment for cellular infiltration and tissue ingrowth, improving structural stability and facilitating the healing process by mimicking natural bone structure and resorbing at a controlled rate, thus addressing the limitations of existing synthetic bone substitutes.

Implementation Method 1

The calcium sulfate pore-filling material will be resorbed more quickly in the early stages of the healing process

Methodology Applied
Scientific EffectResorption: Decomposition (biological)

Implementation Method 2

The interconnected structure created by the reticulated framework provides scaffolding where mesenchymal stem cells can multiply and differentiate into bone forming cells

Methodology Applied
Scientific EffectCellular differentiation:

Implementation Method 3

The presence of the calcium sulfate also strengthens the construct, which improves stability of the reticulated structure following implantation

Methodology Applied
Scientific EffectStructural reinforcement:

Data Source

PatentUS7766972B2Synthetic, malleable bone graft substitute material
Publication Date: 2010.08.03 WRIGHT MEDICAL TECHNOLOGY INC
  • US7766972B2 patent drawing

AI summary

The invention includes a synthetic bone substitute material suitable for use as a replacement for cancellous bone in a bone graft composition, the material comprising a reticulated framework of interconnecting bioceramic struts defining an interconnecting interstitial void volume, and a solid non-porous composition substantially filling the interstitial void volume and in intimate contact with the reticulated framework, the pore-filling composition comprising calcium sulfate. Calcium triphosphate is a preferred bioceramic material for the reticulated framework.