Degradable Occluder with Heat-Melted Connector
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Solution Overview
Problem
Existing occluders for structural heart diseases, such as atrial septal defect, patent ductus arteriosus, ventricular septal defect, and patent foramen ovale, face issues with long-term risks due to non-degradability, poor compliance and recovery, and potential for complications like inflammation and thrombosis, as well as difficulties in intraoperative adjustments and replacements.
Innovation Solution
A degradable occluder composed of sequentially connected disc-shaped meshes with a heat-melted tubular connector, made from biocompatible macromolecule filaments, which allows for temporary heart defect repair and reduces thrombosis risk through a smooth mesh surface and improved endothelialization, enabling easy intraoperative adjustments and replacements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If non-degradable metal alloy materials (nitinol) are used for occluders, then structural strength and durability are improved, but long-term biocompatibility and safety deteriorate due to inflammation, coagulation, and tissue damage
Solution Approach 1:
The patent changes the material parameter from non-degradable metal alloy to degradable polymer materials (polylactic acid, polyglycolic acid, or their copolymers). This parameter change allows the occluder to maintain structural strength during the healing period and then gradually degrade, eliminating long-term biocompatibility issues while providing temporary structural support
Solution Approach 2:
The patent applies the concept of disposable/short-living objects by designing an occluder that serves its function temporarily and then degrades. The degradable polymer occluder provides necessary structural support during the critical healing period and is naturally absorbed by the body after completing its mission, eliminating the need for permanent implantation
2Reliability
If permanently implanted non-degradable occluders are used, then immediate closure effectiveness is improved, but adaptability to patient growth and future interventions deteriorates
Solution Approach 1:
The degradable occluder is designed as a temporary device that provides effective closure during the critical period and then naturally degrades as the patient grows or when future interventions are needed, providing adaptability without compromising initial closure effectiveness
3Duration of action of moving object
If degradable occluders with poor compliance and recovery are used, then material degradation is achieved, but device complexity increases due to need for locking devices
Solution Approach 1:
The patent optimizes the polymer material parameters (molecular weight, crystallinity, composition ratios of polylactic acid and polyglycolic acid) to achieve appropriate degradation rates and mechanical properties without requiring additional locking devices, thereby reducing device complexity while maintaining controlled degradation
Solution Approach 2:
The patent uses composite polymer materials (copolymers of polylactic acid and polyglycolic acid in various ratios) to achieve both compliance and recovery properties, eliminating the need for complex locking mechanisms while maintaining structural integrity during deployment
4Strength
If convex centers are used in disc surfaces of occluders, then structural support is improved, but harmful factors increase due to local thrombosis risk and poor endothelialization
Solution Approach 1:
The patent inverts the surface geometry principle by creating concave centers instead of convex centers on the disc surfaces. This curvature change promotes blood flow and endothelial cell migration toward the center, reducing thrombosis risk while maintaining structural support through the overall disc shape and polymer material properties
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 degradable occluder provides a temporary solution for heart defect repair, minimizing long-term complications, reducing surgical risks, and ensuring effective sealing and recovery without the need for locking devices, while being easily adjustable during operations.
Implementation Method 1
the connector is formed by heat-melting the mesh body of the second disc-shaped mesh
Data Source
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AI summary
A degradable occluder, which comprises a first disc-shaped mesh (10), a tubular mesh (30), and a second disc-shaped mesh (20), which are sequentially connected, wherein both ends of the tubular mesh (30) are respectively connected to the first disc-shaped mesh (10) and the second disc-shaped mesh (20), wherein the first disc-shaped mesh (10), the tubular mesh (30), and the second disc-shaped mesh (20) are integrally formed. The second disc-shaped mesh (20) is provided with a connector (40) used for closing the mesh surface wherein the connector (40) is formed by heat-melting the mesh body of the second disc-shaped mesh (20), wherein the materials of the first disc-shaped mesh (10), the tubular mesh (30), the second disc-shaped mesh (20) and the connector (40) are all degradable materials. The closing structure of the occluder by closing line increases the support and resilience of the occluder, wherein it reduces manufacturing difficulty and cost, not only allows degradable filaments composing the disc-shaped meshes (10, 20) to be firmly connected together, but also allows the connector (10) to be firmly connected together with the degradable wires composing the disc-shaped meshes (10, 20), thus it will not be prone to falling off.