Heart Valve Implant Inflow Stitching for Percutaneous Delivery
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Solution Overview
Problem
Current medical devices for replacing heart valves are often invasive and require significant recovery time, and there is a need for less invasive alternatives that can effectively diagnose, treat, and repair cardiovascular system inefficiencies, particularly for defective heart valves like the aortic or mitral valves.
Innovation Solution
A replacement heart valve implant comprising a tubular anchor member that can be actuated between delivery and deployed configurations, with valve leaflets and a seal member secured to the anchor member, allowing for percutaneous delivery and minimally invasive implantation, featuring a fabric strip embedded in a polymeric seal element for enhanced security and functionality.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical methods are used to replace heart valves, then the replacement is effective and reliable, but the procedure is highly invasive and requires significant recovery time
Solution Approach 1:
The replacement valve is divided into separate functional components: a tubular anchor member for securing to the vessel wall, valve leaflets for flow control, and a seal member for preventing leakage. These segmented components can be delivered and deployed separately through catheter-based approaches, reducing invasiveness while maintaining reliability
Solution Approach 2:
A delivery catheter system serves as an intermediary device that enables the replacement valve to be delivered percutaneously rather than through open surgery. The catheter provides a minimally invasive pathway while ensuring proper positioning and deployment of the valve components
2Ease of manufacture
If a simple seal member attachment is used, then the manufacturing process is easier, but the security and functionality of the seal member attachment is insufficient
Solution Approach 1:
The seal member uses a composite construction with a fabric strip embedded in a polymeric seal element. The fabric provides structural reinforcement and attachment points, while the polymeric material provides sealing functionality. This composite approach achieves reliable attachment without overly complex manufacturing
Solution Approach 2:
The fabric strip is pre-embedded within the polymeric seal element during manufacturing, creating a pre-assembled unit that combines the benefits of both materials. This preliminary integration simplifies the overall assembly process while ensuring secure attachment capability
Data Source
AI summary
A replacement heart valve implant may include a tubular anchor member actuatable between a delivery and a deployed configuration, the tubular anchor member including an inflow end, an outflow end, and a plurality of anchor member intersection points, and defining a longitudinal axis extending from the inflow end to the outflow end, a plurality of valve leaflets, and a seal member secured to the tubular anchor member at the inflow end. An end surface of each of the plurality of valve leaflets may abut an inner-facing surface of the seal member. The plurality of valve leaflets each define a secured end and a free end. The secured end may be attached to the seal member adjacent the inflow end. The secured end may define the end surface, and the end surface may face toward the outflow end when the plurality of valve leaflets is in an everted position.