Composite Bone Grafts with Segmented Mineral Dissolution
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Solution Overview
Problem
Current bone grafts face limitations such as limited availability of autografts, variability in allograft performance, and the need for superior osteogenic properties to enhance bone regeneration throughout the healing phase.
Innovation Solution
Bone grafts comprising 20% to 95% collagen Type I and 20% to 95% minerals with different dissolution properties and/or sizes, prepared by mixing, refrigerating, blast chilling, and freeze drying, with optional incorporation of hyaluronic acid and demineralized bone matrix, to create a homogenous mixture that can be physically or chemically cross-linked for enhanced bone healing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If autograft is used as bone graft substitute, then osteogenic properties are improved, but availability is limited and donor site morbidity increases
Solution Approach 1:
The patent creates a synthetic copy of natural bone tissue by combining collagen type I (providing organic matrix structure) with multiple minerals including calcium phosphate and carbonate apatite (providing inorganic bone mineral composition). This synthetic bone graft substitute replicates the biphasic structure of natural bone, achieving osteogenic properties without requiring autograft harvesting
Solution Approach 2:
The invention uses a composite material system consisting of collagen type I as the organic phase and multiple mineral phases (calcium phosphate, carbonate apatite, and other biocompatible minerals) to create a synthetic bone graft. This composite structure mimics natural bone's organic-inorganic composition and provides both structural integrity and osteogenic functionality
2Adaptability or versatility
If allograft is used as bone graft substitute, then availability is improved, but performance variability increases
Solution Approach 1:
The patent controls and standardizes the composition parameters of the bone graft substitute by specifying precise ratios of collagen type I (20-95 wt%) and minerals (20-95 wt%), with controlled particle size distributions (75 nm to 500 μm). This parameter control ensures consistent performance across different batches and manufacturers, eliminating the variability inherent in allografts from different donors
Solution Approach 2:
The invention achieves homogeneity in the bone graft substitute through controlled mixing and processing methods that ensure uniform distribution of collagen and mineral phases. The standardized composition and processing create a consistent product with predictable performance, contrasting with the inherent variability of allografts from different sources
3Ease of manufacture
If single mineral type is used in bone graft, then manufacturing simplicity is improved, but bone regeneration throughout healing phase is insufficient
Solution Approach 1:
The patent segments the mineral phase into multiple types with different dissolution rates: fast-dissolving minerals (such as calcium phosphate) for early bone regeneration, and slow-dissolving minerals (such as carbonate apatite) for late-stage regeneration. This segmentation allows each mineral type to act at different time points during the healing process, extending the duration of osteogenic activity
Solution Approach 2:
The multi-mineral composition creates a periodic release pattern of calcium and phosphate ions during bone regeneration. Fast-dissolving minerals provide initial ion release for early osteogenesis, while slow-dissolving minerals provide sustained ion release for later stages, creating a temporally distributed osteogenic stimulus throughout the healing phase
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 grafts provide a consistent and effective osteogenic solution that enhances bone regeneration in both early and late phases of healing, reducing the need for autografts and minimizing variability in allograft performance, while supporting new bone formation and entrapment of growth factors and osteoprogenitor cells.
Implementation Method 1
blast chilling the mixture at a temperature below -20° C for 1 hour up to 24 hours
Implementation Method 2
freeze drying the mixture for 24 to 72 hours
Data Source
Figure 1
AI summary
Provided herein are bone grafts and methods of making and using the same, as well as products and kits that include such bone grafts. In particular, bone grafts are provided that include collagen Type I and one or more different types of mineral compositions having different dissolution properties and/or sizes, to enhance bone regeneration throughout the bone healing phase.