Autologous Blood Coagulum for Bone Defect Repair
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Solution Overview
Problem
Current BMP-based therapies for bone defects rely on bovine-derived collagen matrices, which are costly, immunogenic, and pose risks of bovine spongiform encephalopathy, and alternative carriers like hydroxyl apatite salts and synthetic polymers may cause tissue irritation and unknown physiological effects, limiting effective and affordable treatment options.
Innovation Solution
A whole blood-derived coagulum device (WBCD) is developed, comprising whole blood, osteogenic proteins, and calcium ions, optionally with a fibrin-thrombin mixture, to create a homogeneous, cohesive, and injectable coagulum gel for treating bone defects, using autologous or crossmatched blood to enhance retention and delivery of osteogenic proteins.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If bovine-derived collagen matrix is used as carrier for BMP therapy, then structural integrity and BMP delivery capability are improved, but cost increases, immunogenicity risk increases, and BSE contamination risk exists
Solution Approach 1:
The patent uses autologous whole blood coagulum as a temporary, disposable carrier that forms a stable clot in situ at the bone defect site. This eliminates the need for expensive, long-lasting synthetic or animal-derived collagen matrices. The blood coagulum provides sufficient structural support during the critical early healing phase and then naturally degrades, avoiding immunogenicity and BSE risks associated with bovine products.
Solution Approach 2:
The patent employs the patient's own blood as the carrier material, which is readily available and requires no external processing. The autologous blood coagulum serves multiple functions: it provides structural integrity, delivers BMPs, and eliminates rejection or immunogenic responses. This self-service approach replaces complex manufactured collagen products with a simple, biocompatible alternative.
2Reliability
If bovine collagen matrix is used for BMP delivery, then BMP retention and bone formation capability are improved, but purification and processing costs increase significantly
Solution Approach 1:
The blood coagulum acts as a temporary, inexpensive carrier that requires no complex purification or manufacturing processes. It is prepared directly from the patient's blood at the time of surgery, eliminating costly downstream processing steps required for bovine collagen products while providing adequate BMP retention during the critical early healing period.
Solution Approach 2:
The blood coagulum serves as a natural intermediary matrix that facilitates BMP delivery to bone defect sites. It provides a biocompatible environment for BMP retention and osteogenic differentiation without requiring the extensive purification and processing steps needed for bovine collagen matrices, thereby reducing manufacturing costs while maintaining therapeutic efficacy.
3Reliability
If synthetic polymers or hydroxyl apatite salts are used as carriers, then BMP delivery is achieved, but tissue irritation and unknown physiological effects occur
Solution Approach 1:
The patent uses autologous blood, which is chemically and biologically homogeneous with the patient's own tissue environment. This eliminates the foreign body response and tissue irritation associated with synthetic polymers and hydroxyl apatite salts. The blood coagulum integrates seamlessly with surrounding tissues, providing BMP delivery without causing adverse local reactions or unknown physiological effects.
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 WBCD provides a cost-effective, immunologically acceptable, and biocompatible carrier for osteogenic proteins, enhancing bone growth and healing by maintaining protein retention at the defect site, improving bone formation and reducing the risk of adverse reactions.
Implementation Method 1
combining: (1) whole blood, (2) an osteogenic protein, (3) exogenously provided calcium chloride
Implementation Method 2
the exogenously provided calcium ion is present at a concentration that is effective to provide a homogeneous, cohesive, syringeable, injectable, and malleable coagulum gel
Data Source
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AI summary
Whole blood-derived coagulum devices are described for use in treating bone defects.