Injectable Bone Substitute with Intrinsic Pore Formation
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Solution Overview
Problem
Existing bone replacement materials often lack stability and homogeneity over time, leading to sedimentation issues and difficulties in administration through cannulas, particularly with calcium phosphate compositions where a solid phase settles under an aqueous phase.
Innovation Solution
The use of particles with diameters adapted to injection cannula sizes, mixed with binding substances and stabilizers to prevent sedimentation, combined with a hydrogel component that acts as both a pore former and cohesion promoter, ensuring a homogeneous suspension and injectability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If calcium phosphate particles are mixed with aqueous phase for injectable bone replacement material, then the material becomes processable and injectable, but phase separation and sedimentation occur over time
Solution Approach 1:
The patent uses a composite system combining calcium phosphate particles (beta-TCP, hydroxyapatite) with a specific aqueous carrier phase containing hydrogel-forming polymers (hyaluronic acid, chitosan, gelatin) and surfactants. This composite structure allows the material to remain injectable while preventing phase separation through the stabilizing effects of the polymer-surfactant system that maintains homogeneous suspension over time.
Solution Approach 2:
The patent introduces surfactants and hydrogel-forming polymers as intermediary substances between the calcium phosphate particles and the aqueous carrier. These intermediaries prevent direct phase separation by creating a stable emulsion-like system where the particles remain suspended homogeneously, eliminating the need for centrifugation while maintaining injectability.
2Strength
If large calcium phosphate particles are used to maintain structural stability, then the material strength is improved, but the material cannot be administered through standard injection cannulas
Solution Approach 1:
The patent optimizes the particle size parameters of calcium phosphate to a specific range (10-300 μm, with preferred ranges of 20-100 μm or 50-200 μm). This parameter optimization allows particles to be small enough for injection through standard cannulas while maintaining sufficient structural stability and strength for bone replacement applications.
Solution Approach 2:
The patent employs a particle size distribution where different particle sizes serve different functions: larger particles (closer to 300 μm) provide structural framework and strength, while smaller particles (closer to 10 μm) ensure flowability and injectability. This local quality differentiation within the composite allows simultaneous achievement of strength and injectability.
3Ease of operation
If the calcium phosphate composition is made plastically deformable for easy injection, then the ease of operation is improved, but the material loses its structural stability
Solution Approach 1:
The patent creates a dynamic material system that exhibits plastic deformability during injection (when shear force is applied) but maintains structural stability after implantation. The hydrogel-forming polymers and surfactants enable the material to flow under injection pressure while the calcium phosphate particle network provides structural integrity once positioned, achieving both deformability and stability at different stages.
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 solution provides a phase- and sedimentation-stable, plastically deformable implant material with intrinsic pore formation, maintaining homogeneity and allowing minimal invasive injection into bone defects, promoting bone ingrowth and resorbability.
Implementation Method 1
The water-soluble organic binder substance can be designed to form a hydrogel in the applied state
Implementation Method 2
mixed with binding substances and stabilizers to prevent sedimentation, combined with a hydrogel component that acts as both a pore former and cohesion promoter, ensuring a homogeneous suspension
Data Source
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AI summary
The invention relates to a phase-stable and sedimentation-stable, plastically deformable preparation with intrinsic pore forming, which can be used, for example, for filling bone defects and for augmentation, and also to a method of producing it. The object of the invention, namely to provide a phase-stable and sedimentation-stable, plastically deformable implant material with intrinsic pore forming that can be realized at low cost and inconvenience and can be introduced by injection into a bone defect or alternatively, as a kneadable compound, can be applied/adapted into a bone defect, is achieved by virtue of a plastically deformable preparation for bone construction/replacement, based on ceramic suspensions, comprising a particulate, porous component of low water-solubility and at least one liquid, wax-like or gel-like component in solution in water or alcohol, the component of low water-solubility amounting to 60-98% by weight and the component in solution in water or alcohol amounting to 1-30% by weight, the particles of the particulate component having a diameter in a size range which is substantially greater than one phagocytable particle and smaller than the passage diameter of standard injection cannulas, and the fraction of the dissolved component in the water or alcohol amounting to 0.1%-3% by weight.