Resorbable Polymeric Fetal Heart Valve for Growth and Tissue Ingrowth
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Solution Overview
Problem
Existing heart valves for treating single ventricle heart disease in newborns require frequent replacements due to somatic growth and degeneration, leading to high morbidity and mortality, and transcatheter interventions pose risks.
Innovation Solution
Development of a biodegradable polymeric heart valve with a multi-layered structure, comprising synthetic and naturally derived polymers, and a frame that can be deployed transcatheter to support tissue ingrowth, using a catheter system with pressure monitoring for precise deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional prosthetic valves are used in children, then the valve provides immediate structural support, but the valve requires frequent replacement due to somatic growth and degeneration
Solution Approach 1:
The patent applies preliminary action by providing mechanical support through a stent frame and polymeric coating immediately, while simultaneously initiating the biological process of tissue ingrowth that will eventually replace the synthetic components. The stent frame and coating are designed to degrade at controlled rates, transferring load to the forming native tissue before complete degradation occurs, thus preparing the biological replacement in advance while maintaining immediate structural support.
Solution Approach 2:
The patent employs parameter changes by designing the stent frame and polymeric coating with specific degradation rates and mechanical properties that change over time. The materials are selected and engineered to have initial strength sufficient to support the heart valve function, then gradually degrade as native tissue forms and takes over the load-bearing function, ultimately achieving permanent biological replacement without requiring surgical intervention for replacement.
2Reliability
If multiple valve replacements are performed during childhood, then the valve function is maintained, but the morbidity and mortality increase
Solution Approach 1:
The patent applies self-service by designing a system where the patient's own body performs the replacement function. The stent frame and polymeric coating serve as temporary scaffolds that guide and support the formation of native heart valve tissue by the patient's own cells. Once the native tissue is fully formed and functional, it replaces the synthetic components, eliminating the need for future surgical replacements and associated risks.
3Adaptability or versatility
If a biodegradable tissue-engineered valve is used, then the valve can grow with the patient and avoid multiple replacements, but the deployment procedure must be highly precise to minimize risks
Solution Approach 1:
The patent applies the nested doll principle by designing a multi-component system where the polymeric coating is applied to the stent frame, and both are delivered through a catheter in a compressed, nested configuration. The stent frame provides the outer structural support while the polymeric coating is nested within or upon it. During deployment, they expand together in a coordinated manner, ensuring precise positioning and immediate structural integrity while minimizing delivery profile for safe catheter-based delivery.
4Strength
If a multi-layered polymeric structure is used, then the valve provides optimal mechanical support and biocompatibility, but the manufacturing process becomes more complex
Solution Approach 1:
The patent applies merging by combining the stent frame and polymeric coating into a single integrated delivery system. Both components are manufactured separately with optimized properties, then assembled and delivered together through the catheter as a unified structure. This integration simplifies the manufacturing process by reducing the number of separate assembly steps required after deployment, while maintaining the mechanical advantages of the multi-layered structure.
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 biodegradable valve allows for growth with the patient, reducing the need for multiple replacements and minimizing procedural risks through precise deployment and tissue integration.
Implementation Method 1
A bioresorbable tissue-engineered valve that could be replaced by the patient's own tissue could allow the valve to grow with the patient... A goal of a resorbable valve is for the tissue-engineered scaffold to serve as a template to direct tissue formation. As the scaffold degrades, the neotissue can form
Data Source
AI summary
An exemplary embodiment of the present disclosure provides a method for producing a resorbable heart valve, the method comprising: providing a first solution comprising a polymeric material; coating at least a portion of a mold with the first solution for form a coating; forming a plurality of valve leaflets on a first end of the coating; placing a frame around at least a portion of the coating; and attaching the frame to the coating.