Sterilized Collagen Scaffolds with Covalently Attached Adjuncts
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Solution Overview
Problem
Existing bioimplants face challenges with growth factor delivery, including diffusive release rates that are not optimal, excessive degradation, and potential systemic effects, particularly for less porous tissues like heart valves, skin grafts, tendon, and bone.
Innovation Solution
Chemically sterilized bioimplants with covalently attached adjunct molecules, such as heparin, using carbodiimides like EDC in the presence of alcohols, allowing controlled release and reduced degradation, suitable for tissues like tendon, ligament, and bone.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If growth factor is infused into bioimplant by soaking, then growth factor delivery is achieved, but release rate is uncontrolled and diffusion into surrounding tissue occurs
Solution Approach 1:
The growth factor is covalently bonded to the collagen scaffold during the manufacturing process, establishing a controlled release mechanism in advance. This preliminary chemical modification ensures that the growth factor remains attached to the scaffold and is released gradually as the scaffold degrades, rather than diffusing freely into surrounding tissue.
Solution Approach 2:
The collagen scaffold acts as an intermediary carrier that mediates between the growth factor and the surrounding tissue. By covalently bonding the growth factor to the scaffold, the system controls the release kinetics through the scaffold's degradation rate, preventing uncontrolled diffusion while maintaining sustained delivery.
2Duration of action of moving object
If excess growth factor is infused into bioimplant, then effective release period is extended, but local concentration causes diffusion into surrounding tissue and systemic effects
Solution Approach 1:
The invention changes the fundamental parameter of growth factor attachment from physical infusion to covalent bonding. This chemical modification alters the release kinetics from diffusion-controlled to degradation-controlled, extending the effective release period while maintaining low local concentrations that prevent systemic effects.
Solution Approach 2:
The collagen scaffold provides a porous structure that allows controlled diffusion of the covalently bonded growth factor as it degrades. The porous architecture maintains surface area for cell infiltration while the covalent bonds prevent premature release, achieving extended duration without excessive local concentration.
3Strength
If bioimplant is made less porous for structural integrity, then mechanical strength is improved, but growth factor infusion effectiveness is reduced
Solution Approach 1:
The growth factor is covalently bonded to the collagen scaffold during manufacturing, before implantation. This preliminary attachment eliminates the need for post-manufacturing infusion, allowing the scaffold to be optimized for mechanical strength without compromising growth factor delivery capability.
Solution Approach 2:
The invention creates a composite system where the growth factor is chemically integrated with the collagen scaffold structure. This composite approach allows the scaffold to provide both mechanical support and controlled growth factor delivery, combining structural integrity with biological 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
The bioimplants provide sustained, regulated release of adjuncts, promoting tissue healing and remodeling with reduced systemic effects, suitable for various surgical applications including tendon, ligament, and bone repair.
Implementation Method 1
crosslinking the tissues to mask antigenic molecules in the tissue
Implementation Method 2
the sterilization is carried out in the presence of a penetration enhancer
Implementation Method 3
have adjunct molecules covalently attached (conjugated) thereto
Data Source
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AI summary
Bioimplants and methods of making the bioimplants are provided. The bioimplants comprise biological tissues having conjugated thereto adjunct molecules. The biological tissues are sterilized with a chemical sterilizing agent, such as a water soluble carbodiimide. The processes of making the bioimplants include a process in which an adjunct molecule is conjugated to a biological tissue during the sterilization process.