Hydratable Bone Material Using Vacuum-Assisted Uniform Hydration
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Solution Overview
Problem
Existing bone graft materials, particularly demineralized bone matrix (DBM), face issues with cohesion during processing and hydration, leading to clogging and uneven distribution, and often require binders that complicate manufacturing and regulatory approval.
Innovation Solution
A method for making hydrated bone material using milled and lyophilized demineralized bone fibers, which are mixed with a liquid without a binder, utilizing a syringe system to create a vacuum for uniform hydration, forming a moldable coherent mass that can be injected into surgical sites.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If DBM fibers are made without a binder, then manufacturing cost is reduced and regulatory approval is simplified, but the fibers lack cohesiveness and tend to fall apart or become loose during processing
Solution Approach 1:
The DBM fibers are processed to create a porous structure that allows liquid to be absorbed and retained within the fiber matrix. This porosity enables the fibers to cohere through capillary action and liquid retention without requiring external binders, resolving the contradiction between manufacturing simplicity and structural cohesiveness.
Solution Approach 2:
The DBM fiber system uses its own inherent properties (porosity, surface area, and liquid absorption capacity) to achieve cohesiveness without external binding agents. The fibers self-cohere through liquid retention and capillary forces, eliminating the need for additional binder materials and simplifying manufacturing.
2Volume of stationary object
If bone material is tightly packed in the syringe or chamber, then the syringe or chamber size is reduced, but the bone material may not be uniformly hydrated causing clumps and clogging
Solution Approach 1:
The bone material is processed into fine, uniformly sized particles with controlled morphology. This segmentation into consistent small units allows for better packing density while maintaining uniform liquid distribution throughout the material, preventing clumps and ensuring homogeneous hydration even in compacted states.
Solution Approach 2:
The porous structure of the processed bone material allows liquid to penetrate deeply and uniformly throughout the packed material. The porosity creates interconnected pathways that facilitate even hydration distribution, preventing localized clumping even when the material is tightly packed in the syringe or chamber.
3Ease of operation
If bone material is hydrated with liquid in a closed system, then the dispensing process is simplified, but the bone material can be improperly hydrated causing the syringe or chamber to clog
Solution Approach 1:
The bone material undergoes parameter changes during processing, including controlled particle size reduction, porosity adjustment, and surface area optimization. These parameter changes ensure the material has optimal liquid absorption characteristics that prevent both under-hydration (clogging) and over-hydration (excessive viscosity), enabling reliable dispensing from closed systems.
Solution Approach 2:
The processed bone material exhibits optimized hydraulic properties that allow for uniform liquid distribution and flow characteristics. The controlled porosity and particle morphology enable proper hydration kinetics that prevent clogging during closed-system dispensing, while maintaining ease of operation through predictable fluid dynamics.
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 method ensures uniform hydration and cohesion of DBM, eliminating the need for binders and reducing manufacturing complexity, while allowing for effective osteogenesis, osteoinduction, and osteoconduction without clogging issues.
Implementation Method 1
utilizing a syringe system to create a vacuum for uniform hydration
Implementation Method 2
The processed bone material has improved liquid distribution characteristics that facilitate uniform hydration
Data Source
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AI summary
In some embodiments, a method of making hydrated bone material is provided, the method comprising providing a bone material in a chamber, the bone material comprising a plurality of shaped bone particles or macroparticles, each of the plurality of shaped bone particles or macroparticles having a substantially uniform size, shape and porosity; and mixing each of the plurality of shaped bone particles with liquid in the chamber under pressure so as to cause the liquid to hydrate each of the plurality of shaped bone particles to form uniformly hydrated bone material. In some embodiments, a device for mixing a bone material with a liquid is provided.