Stem Cell Seeded Cortical Fibers for Bone Augmentation

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Solution Overview

Problem

Current bone allografts, while promoting healing, have a lengthy and arduous healing process, necessitating the development of more effective bone augmentation compositions that enhance bone regeneration.

Innovation Solution

A method involving hydrating cortical fibers with cell culture media, seeding them with human mesenchymal stem cells, and culturing the allograft to grow a stem cell population before freezing for storage, which upon thawing maintains a viable cell density of 5×10^4 to 1×10^6 cells/ml, optimizing stem cell survival and attachment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If bone allografts are used to promote healing, then bone regeneration is enhanced, but the healing process becomes lengthy and arduous

Engineering Contradiction:
Improvebone regeneration effectivenessVSAvoidhealing time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent applies preliminary action by pre-seeding cortical bone allografts with mesenchymal stem cells and growth factors before implantation. The allografts are prepared in advance in a bioreactor where stem cells are cultured and attached to the bone matrix, allowing osteogenic differentiation to begin before the graft is implanted. This preliminary preparation accelerates the healing process by having bone-forming cells already in place when the graft is implanted, rather than waiting for the patient's own cells to migrate and populate the graft site.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent applies parameter changes by modifying the biological parameters of the allograft through controlled culture conditions. The bioreactor system adjusts parameters such as oxygen tension, growth factor concentrations, and mechanical stimulation to promote osteogenic differentiation of stem cells. By changing these biological parameters during preparation, the graft is transformed into a more osteogenic state that accelerates bone regeneration and reduces healing time.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If stem cells are seeded and cultured on allografts to enhance osteogenesis, then bone regeneration is improved, but the process complexity increases

Engineering Contradiction:
Improvebone regeneration effectivenessVSAvoidprocessing complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies self-service by using the allograft's own demineralized bone matrix to provide attachment sites and growth factors for stem cell cultivation. The bone matrix itself serves as the substrate and nutrient source, eliminating the need for external scaffolds or complex support structures. The allograft naturally provides the biochemical and structural environment needed for stem cell attachment, proliferation, and differentiation, simplifying the overall process despite the added step of cell seeding.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent applies universality by using a single component - the demineralized bone allograft - to perform multiple functions: providing structural support, serving as a cell attachment substrate, delivering growth factors, and acting as a scaffold for new bone formation. This multi-functional approach consolidates what would otherwise require multiple separate components into one universal material, reducing overall system complexity while maintaining enhanced osteogenic capabilities.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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

This approach results in a bone augmentation composition with a high surviving stem cell population post-thaw, enhancing bone regeneration and reducing the healing time by minimizing stem cell attachment during the culturing process.

Implementation Method 1

hydrating an allograft comprising cortical fibers with a cell culture media

Methodology Applied
Scientific EffectAbsorption: Absorption (physical)

Implementation Method 2

freezing the stem-cell seeded allograft containing the cell culture media with a cryopreservation solution

Methodology Applied
Scientific EffectFreezing: Freezing

Data Source

PatentUS20220387511A1Stem cell impregnated cortical fibers
Publication Date: 2022.12.08 ZAVATION MEDICAL PRODUCTS LLC
  • US20220387511A1 patent drawing
  • US20220387511A1 patent drawing
  • US20220387511A1 patent drawing

AI summary

A bone augmentation composition and a method for making the bone augmentation. The method including hydrating an allograft comprising cortical fibers with a cell culture media, seeding the hydrated allograft with a solution of human stem cells, and culturing the stem-cell seeded allograft to grow a population of the stem cells in the seeded graft prior to freezing the bone augmentation composition for storage.