DBM-Gelatin Matrix Allograft for Bone Healing

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Solution Overview

Problem

Bone fracture sites are prone to infections, with some infections having high mortality rates, and existing treatments for wounds and bone fractures are not effective in preventing infections or promoting immediate and effective healing.

Innovation Solution

A demineralized bone matrix (DBM) graft with a gelatin carrier is formed by milling and demineralizing bone material, mixing it with porcine or collagen-based gelatin, and performing a crosslinking reaction to create a DBM-gelatin matrix allograft material, which can be used as an implant or applied to wounds, promoting bone growth and healing while potentially incorporating antibiotics or growth factors.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional bone graft treatments are used, then bone fracture sites are treated, but infection risk remains high and healing is not effective

Engineering Contradiction:
Improveinfection prevention and healing effectivenessVSAvoidinfection risk at bone fracture sites
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The gelatin carrier acts as an intermediary substance that delivers demineralized bone matrix (DBM) and growth factors to the fracture site. The gelatin matrix provides a biocompatible scaffold that facilitates controlled release of osteoinductive agents, thereby preventing infection and promoting effective bone healing without direct contact with harmful environmental factors.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention combines demineralized bone matrix (DBM) with gelatin carrier to create a composite bone graft material. This composite structure integrates the osteoinductive properties of DBM with the biocompatible, infection-resistant characteristics of gelatin, resulting in a material that simultaneously prevents infection and promotes effective bone healing.

Inventive Principle:
Principle #40Composite materials

2Manufacturing precision

If bone material is processed through milling and demineralization, then DBM is formed, but the material requires additional processing steps to become usable

Engineering Contradiction:
ImproveDBM particle size and composition controlVSAvoidnumber of processing steps
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The invention merges the DBM formation process with the gelatin carrier integration into a single composite material preparation step. After milling and demineralization to create DBM particles with controlled size (400-800 μm), the DBM is directly mixed with gelatin solution to form a unified composite graft material, reducing the need for separate processing steps.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The invention controls DBM particle size parameters through standardized milling and sieving processes (400-800 μm range) and adjusts gelatin concentration parameters to optimize the composite material properties. By controlling these physical parameters, the material achieves usable form with improved handling characteristics while minimizing processing complexity.

Inventive Principle:
Principle #35Parameter changes

3Productivity

If DBM is mixed with gelatin carrier at optimal ratios, then bone growth is enhanced, but material composition becomes more complex

Engineering Contradiction:
Improvebone growth rate and healing speedVSAvoidmaterial composition complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The invention optimizes the DBM to gelatin carrier ratio parameter to enhance bone growth productivity. By establishing an optimal concentration range for gelatin and DBM components, the composite material achieves accelerated bone healing while maintaining composition within manageable complexity limits suitable for clinical application.

Inventive Principle:
Principle #35Parameter changes

4Stability of the object's composition

If crosslinking reaction is performed on DBM-gelatin solution, then structural stability is improved, but the processing time increases

Engineering Contradiction:
Improvestructural stability of bone graftVSAvoidcrosslinking reaction time
Core Design Contradiction:
Stability of the object's compositionVSLoss of time

Solution Approach 1:

The invention adjusts the crosslinking reaction parameters including temperature, pH, and crosslinking agent concentration to achieve optimal structural stability in minimal time. By optimizing these chemical parameters, the DBM-gelatin composite reaches its maximum structural stability faster, reducing the time loss associated with the crosslinking process.

Inventive Principle:
Principle #35Parameter changes

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 DBM-gelatin matrix allograft material enhances bone growth and healing, reduces infection risk, and can be used to secure severed bone portions or applied to wounds, offering a biocompatible and osteoconductive solution for bone repair and reconstruction.

Implementation Method 1

performing a crosslinking reaction with the DBM-gelatin solution to form a DMB-gelatin matrix allograft material

Methodology Applied
Scientific EffectCrosslinking reaction: Chemical Bonding

Implementation Method 2

adding, to the DBM-gelatin solution, a solution of N-hydroxysuccinimide/1-ethyl-3-(3-(dimethylaminopropyl)carbodiimide hydrochloride (NHS/EDC)

Methodology Applied
Scientific EffectCovalent bonding: Chemical Bonding

Implementation Method 3

demineralizing a bone powder via three incubations of one hour with 0.5-N HCl to create an initial DBM material

Methodology Applied
Scientific EffectAcid demineralization: Chemical Bonding

Data Source

PatentUS20230263941A1Systems, methods, and devices including a demineralized bone matrix (DBM) graft with gelatin carrier
Publication Date: 2023.08.24 THORAGENIX INNOVATIONS INC
  • US20230263941A1 patent drawing
  • US20230263941A1 patent drawing
  • US20230263941A1 patent drawing

AI summary

Systems, methods, and devices include techniques for generating and using a demineralized bone matrix (DBM)-gelatin matrix allograft material. The DBM-gelatin material can be used to form an implant (e.g., for sternal closure operations) and/or a gel (e.g., for wound/fracture treatment). A method for forming the implant or bone graft can include forming the DBM from an initial bone material; and mixing, in a solution, the DBM with a gelatin carrier to form a DBM-gelatin solution. The gelatin carrier can include an animal-based collagen, such as a porcine-based collagen or a bovine-based collagen. Additionally, the method of forming the bone graft can include performing a crosslinking reaction with the DBM-gelatin solution. The implant can be packaged in a sterile hydration container prior to use.