Lyophilized Bone Implants with Oxysterol for Irregular Defects
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Solution Overview
Problem
Current bone grafting methods face challenges with malleable implants that incorporate high levels of mineral particles and osteogenic agents, such as oxysterols, which often lack cohesiveness and are difficult to shape to fit irregular bone defects, and fail to adhere to other medical implants like screws and plates.
Innovation Solution
Development of lyophilized implants containing a biodegradable polymer, mineral particles, and an osteogenic agent like Oxy133, which become moldable upon rehydration, allowing them to be shaped to fit bone defects and adhere to other medical devices, promoting bone growth and fusion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If substantial levels of mineral particles are incorporated into matrix materials, then the implant provides adequate scaffolding for bone growth, but the matrix material becomes difficult to handle, lacks cohesiveness, and is readily broken or eroded away
Solution Approach 1:
The patent employs a composite material system consisting of collagen matrix combined with hydroxyapatite or tricalcium phosphate mineral particles. The collagen provides a flexible, cohesive biological matrix that can be molded, while the mineral particles provide osteoconductivity and scaffolding for bone growth. This composite approach allows the implant to maintain both handling properties and structural support functionality.
2Strength
If carrier scaffolds with ceramics are used, then the implant provides structural support, but the scaffold becomes rigid and cannot fit into irregularly shaped bone defects
Solution Approach 1:
The patent utilizes the dynamic properties of collagen, which transitions from a flexible, moldable state when wet to a more stable state when dried or implanted. This allows the surgeon to mold the collagen-mineral composite into irregular shapes that conform to complex bone defect geometries, while the mineral content provides the necessary structural support once implanted.
Solution Approach 2:
The patent changes the physical state parameters of the collagen matrix by controlling its hydration level. When hydrated, the collagen becomes pliable and moldable; when dehydrated or cross-linked, it gains structural stability. This parameter change allows the same material to provide both moldability during surgery and structural support after implantation.
3Reliability
If traditional bone grafting materials are used, then the implant provides osteogenic properties, but the implant lacks adhesive properties to bind to other medical implants such as screws, rods, and plates
Solution Approach 1:
The patent uses the collagen-mineral composite as an intermediary material that bridges the gap between metallic implants and biological tissue. The collagen matrix provides a biocompatible interface that adheres to both the metal surfaces (through mechanical interlocking and surface chemistry) and the surrounding bone tissue, while the mineral particles provide osteoconductivity and osteogenic stimulation.
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 lyophilized implants effectively promote bone growth and fusion by providing a cohesive, moldable matrix that can be tailored to fit complex bone defects and adhere to other implants, enhancing the efficacy of spinal fusion procedures and other bone repair applications.
Implementation Method 1
Lyophilized implants containing oxysterol and methods of making and using those implants are provided. Upon rehydration, the implants can be formed to fit easily within a bone defect.
Data Source
AI summary
Provided is a lyophilized implant configured to fit at or near a bone defect to promote bone growth, the lyophilized implant containing a biodegradable polymer in an amount of about 0.1 wt. % to about 20 wt. % of the implant, mineral particles in an amount from about 0.1 wt. % to about 75 wt. % of the implant, and an oxysterol in an amount of about 5 wt. % to about 90 wt. % of the implant. Methods of making and using the implant are further provided.