Biphasic Ceramic Bone Substitute for Controlled Regeneration

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Solution Overview

Problem

Current bone grafts, including both autologous and allogenic options, face limitations such as limited supply, donor site morbidity, and risks of disease transmission, while synthetic substitutes lack osteoinductive properties, leading to premature resorption of newly formed bone due to BMP-induced osteoclast activation.

Innovation Solution

A biphasic ceramic bone substitute comprising a resorbable calcium sulphate phase for initial microporosity and mechanical stability, and a stable calcium phosphate phase for slow release of anti-catabolic agents, delivering bone active proteins like BMPs and bisphosphonates to promote controlled bone growth and inhibit resorption.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If BMP is used to induce bone formation, then bone growth is stimulated, but newly formed bone is resorbed prematurely due to osteoclast activation

Engineering Contradiction:
Improvebone formation rateVSAvoidbone retention time
Core Design Contradiction:
ProductivityVSDuration of action of stationary object

Solution Approach 1:

The patent applies preliminary action by incorporating anti-catabolic agents (bisphosphonates) into the bone substitute material before implantation. These agents are released in a controlled manner to preemptively inhibit osteoclast activity and prevent premature bone resorption before it occurs, thereby protecting the BMP-induced bone formation from early degradation

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent uses an intermediary approach by employing a biphasic ceramic material system where hydroxyapatite serves as a carrier for anti-catabolic agents. This intermediary system mediates between the bone formation stimulation (BMP) and bone resorption inhibition (bisphosphonates), allowing both processes to work synergistically without direct conflict

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If autologous bone grafts are used to provide living cells and proteins for osteogenesis, then bone regeneration is enhanced, but donor site morbidity and limited supply occur

Engineering Contradiction:
Improvebone regeneration capabilityVSAvoiddonor site morbidity
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies the copying principle by creating a synthetic bone substitute that replicates the essential functions of autologous bone grafts. The material incorporates osteoinductive factors and living cells within a porous ceramic scaffold, copying the regenerative capabilities of natural bone without requiring harvesting from donor sites, thereby eliminating donor site morbidity while maintaining reliable bone regeneration

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent uses parameter changes by transforming the physical and chemical properties of synthetic materials to match natural bone characteristics. The biphasic ceramic composite is designed with specific porosity, mechanical strength, and surface properties that mimic autologous bone, enabling it to support cell attachment, proliferation, and differentiation while providing sustained release of growth factors

Inventive Principle:
Principle #35Parameter changes

3Object-affected harmful factors

If bone allografts are used as an osteoconductive scaffold, then supply limitations and disease transmission risks are reduced, but osteoinductive properties are lost leading to premature resorption

Engineering Contradiction:
Improvedisease transmission riskVSAvoidbone formation stability
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent applies composite materials by combining hydroxyapatite ceramic with beta-tricalcium phosphate in a biphasic structure. This composite material provides both osteoconductive properties (from hydroxyapatite) and osteoinductive capabilities (through incorporated BMP and other growth factors), while the porous structure supports cell infiltration and new bone formation. The composite nature eliminates disease transmission risks associated with allografts while maintaining bone formation stability through controlled release of bioactive molecules

Inventive Principle:
Principle #40Composite materials

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 biphasic ceramic bone substitute enhances bone regeneration by providing initial mechanical support, controlled release of bone growth factors, and sustained inhibition of bone resorption, leading to denser and stronger new bone formation, addressing the limitations of existing grafts.

Implementation Method 1

The two phases in the ceramic bone substitute consists of a relatively fast resorbable calcium sulphate phase and a very slowly resorbable calcium phosphate phase

Methodology Applied
Scientific EffectCrystallisation: Crystallisation

Implementation Method 2

bone active proteins that can induce and/or stimulate bone growth, e.g. bone morphogenic proteins (BMP)

Methodology Applied
Scientific EffectOsteoinduction:

Implementation Method 3

Intravenously or orally administered bisphosphonates target and bind to bone mineral and such systemic applied bisphosphonates thus mainly accumulate in areas of active bone remodeling

Methodology Applied
Scientific EffectAdsorption: Adsorption

Data Source

PatentEP3274003B1Biphasic ceramic bone substitute
Publication Date: 2019.07.17 BONE SUPPORT AB
  • EP3274003B1 patent drawingFigure 1A~1D
  • EP3274003B1 patent drawingFigure 2A~2F
  • EP3274003B1 patent drawingFigure 3A~3B

AI summary

The present invention shows a biphasic ceramic bone substitute comprising a resorbable calcium sulphate phase and a stable calcium phosphate phase acting as a bone graft and excellent carrier for a combination of bone active proteins (e.g. BMP) and anti-catabolic agents (e.g. bisphosphonates) giving enhanced bone regeneration.