Heart Valve Delivery System Locking Clip Mechanism
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Solution Overview
Problem
Current medical devices for delivering and implanting heart valves are often invasive and require significant recovery times, with existing methods being inefficient for treating defective heart valves, particularly in the cardiovascular system.
Innovation Solution
A medical device system that includes an outer shaft, an exoskeleton, and a medical implant, which can be advanced percutaneously to deliver and deploy a replacement heart valve, featuring a locking clip mechanism for secure attachment and deployment, allowing for less invasive procedures and efficient valve replacement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional open-heart surgery methods are used for heart valve replacement, then reliable valve replacement can be achieved, but patient trauma and recovery time are significantly increased
Solution Approach 1:
The delivery system is divided into multiple separable components including an outer shaft, inner shaft, exoskeleton, and heart valve assembly. This segmentation allows the system to be delivered through a catheter and assembled in situ within the body, avoiding the need for open-heart surgery while maintaining reliable valve replacement
Solution Approach 2:
A self-expanding exoskeleton acts as an intermediary structure that provides radial support and maintains the patency of body lumens during the procedure. The exoskeleton enables the delivery system to navigate tortuous anatomy and provides a stable platform for heart valve deployment without requiring surgical exposure
2Ease of operation
If the delivery system is made flexible to navigate tortuous body lumens, then ease of delivery is improved, but structural integrity and positioning precision may be compromised
Solution Approach 1:
The delivery system employs dynamic elements including a flexible outer shaft that can bend and conform to tortuous anatomy, while inner shafts and coupling members provide rigid structural support when needed. The system transitions from a flexible delivery state to a rigid deployed state, achieving both ease of navigation and positioning precision
Solution Approach 2:
Multiple shafts and components are nested within each other during delivery, with inner shafts contained within the outer shaft. This nested configuration maintains flexibility for navigation while providing precise positioning capability when components are deployed in sequence at the target site
3Ease of manufacture
If attachable components are used to simplify assembly, then ease of manufacture and sterilization is improved, but connection reliability and structural stability may be compromised
Solution Approach 1:
Coupling members are pre-formed with specific geometric features including apertures, protrusions, and recesses that enable reliable attachment. The outer shaft is pre-formed with a coupling member that includes an aperture, and inner shafts are pre-formed with complementary coupling members that have protrusions designed to engage with the aperture, ensuring reliable connection when assembled
Solution Approach 2:
The coupling members combine multiple functions into single integrated structures that provide both mechanical connection and alignment features. The protrusion-aperture interface merges attachment, positioning, and structural reinforcement functions, achieving reliable connections while maintaining ease of assembly
Data Source
AI summary
An example system for delivering an implantable heart valve is disclosed. The system includes an inner shaft having a proximal end region, a distal end region and a first coupling member disposed along a portion of the distal end region, wherein the first coupling member includes a first aperture. The system also includes a support shaft having a proximal end region, a distal end region and a second coupling member disposed along a portion of the proximal end region, wherein the second coupling member includes a stem, wherein the stem includes a groove extending circumferentially around the stem. The system also includes a locking clip coupled to the inner shaft, wherein coupling the inner shaft to the support shaft includes extending at least a portion of the locking clip through the first aperture and into at least a portion of the groove.