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

VSEngineering 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

Engineering Contradiction:
Improvemanufacturing cost and regulatory approvalVSAvoidcohesiveness of DBM fibers
Core Design Contradiction:
Ease of manufactureVSStability of the object's composition

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.

Inventive Principle:
Principle #31Porous materials

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.

Inventive Principle:
Principle #25Self-service

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

Engineering Contradiction:
Improvesyringe or chamber sizeVSAvoiduniformity of hydration
Core Design Contradiction:
Volume of stationary objectVSManufacturing precision

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.

Inventive Principle:
Principle #1Segmentation

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.

Inventive Principle:
Principle #31Porous materials

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

Engineering Contradiction:
Improvedispensing processVSAvoidproper hydration and clogging prevention
Core Design Contradiction:
Ease of operationVSReliability

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.

Inventive Principle:
Principle #35Parameter changes

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.

Inventive Principle:
Principle #29Pneumatics and hydraulics

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

Methodology Applied
Scientific EffectVacuum: Vacuum

Implementation Method 2

The processed bone material has improved liquid distribution characteristics that facilitate uniform hydration

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Data Source

PatentEP4028080B1Methods of making hydratable bone material
Publication Date: 2025.11.05 WARSAW ORTHOPEDIC INC
  • EP4028080B1 patent drawingFigure 1
  • EP4028080B1 patent drawingFigure 2
  • EP4028080B1 patent drawingFigure 3

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.