Sewn Valved Vascular Prosthesis to Reduce Calcification and Stenosis
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Solution Overview
Problem
Existing valved vascular prostheses face issues such as long-term calcification and stenosis, primarily due to the use of glutaraldehyde in the manufacturing process, which limits their effectiveness and durability.
Innovation Solution
A valved vascular prosthesis is developed by sewing a tubular vascular material onto an artificial blood vessel, creating a valve with pocket-shaped openings. This method eliminates the need for glutaraldehyde, simplifying the manufacturing process and improving biocompatibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If glutaraldehyde is used to treat animal-derived vascular materials, then the structural stability and fixation of the prosthesis are improved, but long-term calcification and stenosis occur due to cross-linking reactions
Solution Approach 1:
The invention extracts and removes the harmful glutaraldehyde cross-linking agent from the prosthesis structure. By eliminating the glutaraldehyde treatment step, the patent prevents the formation of cross-linked structures that lead to calcification and stenosis, while maintaining structural integrity through alternative fixation methods
Solution Approach 2:
The invention changes the chemical parameters of the treatment process by replacing glutaraldehyde with alternative fixation methods. This parameter change eliminates the harmful cross-linking reactions while preserving the necessary structural stability and biocompatibility of the prosthesis
2Reliability
If complex decellularization, inactivation, and fixation processes are used on animal-derived materials, then the biocompatibility is improved, but the manufacturing complexity and process time increase
Solution Approach 1:
The invention extracts and removes the complex multi-step processing procedures (decellularization, inactivation, fixation) from the manufacturing process. By using alternative materials or simplified treatment methods, the patent achieves biocompatibility without requiring elaborate processing sequences
Solution Approach 2:
The invention performs necessary biocompatibility preparations in advance through material selection rather than post-processing. By choosing materials that inherently possess biocompatible properties, the patent eliminates the need for subsequent complex treatment steps
3Strength
If glutaraldehyde treatment is applied to animal-derived vascular materials, then the fixation and structural integrity are improved, but the biocompatibility deteriorates due to immunogenic reactions
Solution Approach 1:
The invention extracts and removes glutaraldehyde from the fixation process. By eliminating this immunogenic chemical, the patent prevents adverse immune reactions while maintaining adequate fixation strength through alternative methods such as mechanical suturing or bio-compatible adhesives
Solution Approach 2:
The invention employs composite material strategies by combining vascular materials with biocompatible coatings or alternative fixation agents. This composite approach maintains structural integrity while eliminating the immunogenic effects of glutaraldehyde
Data Source
AI summary
The present invention provides a valved vascular prosthesis and a manufacturing method thereof. The valved vascular prosthesis, comprising an artificial blood vessel and a valve disposed inside for obstruction; the valve is in a skirt state extending toward the centerline of the artificial blood vessel; the valve is made by sewing a tubular vascular material on the artificial blood vessel; one end of the vascular material is connected to the artificial blood vessel along its radial direction, and the other end is a free end; the entire tubular body of the vascular material is sewed on the artificial blood vessel by a plurality of sutures; the sutures are radially parallel to the tubular body of the vascular material, and are arranged at intervals along the circumference of the tubular body of the vascular material. The valved vascular prosthesis of the present invention adopts suture of a polymer material and an artificial blood vessel. When the valved vascular prosthesis is implanted into human body, the valved part is implanted together. The process is simple, easy to mold and has good biocompatibility.