Compressible Stability Tube for Heart Valve Delivery Alignment
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Solution Overview
Problem
Existing transcatheter prosthetic heart valve delivery systems lack stability during deployment, particularly when traversing anatomical curves like the aortic arch, leading to potential misplacement or incomplete deployment.
Innovation Solution
Incorporation of an outer stability tube with a compressible region that is biased to an uncompressed state, allowing the distal end to be positioned close to the capsule, and applying force to retract along with the capsule during sheath retraction, enhancing stability and ensuring complete deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If the outer stability tube is extended closer to the capsule to improve stability during deployment, then stability is improved, but the device complexity increases due to the need for a compressible region with biasing mechanism
Solution Approach 1:
The outer stability tube incorporates a compressible region with variable rigidity that changes from an uncompressed state during delivery to a compressed state during deployment. This parameter change allows the tube to be rigid during delivery for stability and compressible during deployment to allow capsule retraction, resolving the contradiction between stability and complexity.
Solution Approach 2:
The outer stability tube transitions from a static rigid structure during delivery to a dynamic structure that compresses during deployment. The compressible region allows the tube to adapt its length and rigidity based on the operational phase, enabling both stability during delivery and capsule retraction during deployment without permanent structural modification.
2Stability of the object's composition
If the outer stability tube is made rigid to maintain alignment with anatomical pathway, then alignment stability is improved, but the ability to retract along with the capsule during deployment is reduced
Solution Approach 1:
The outer stability tube's rigidity parameter changes along its length and during operation. The compressible region allows the tube to temporarily reduce its rigidity and length during capsule retraction, enabling the capsule to pull away while maintaining overall alignment stability through the remaining rigid portions of the tube.
Solution Approach 2:
The outer stability tube is segmented into rigid portions that maintain alignment and a compressible region that allows deformation. This segmentation enables different portions of the tube to perform different functions simultaneously - the rigid portions maintain anatomical alignment while the compressible region allows capsule retraction.
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
Provides improved stability and ensures full deployment of the prosthetic heart valve by maintaining alignment with the anatomical pathway, reducing the risk of misplacement and incomplete deployment.
Implementation Method 1
The compressible region has an axial compressive strength that is less than an axial compressive strength of the first portion
Data Source
AI summary
Transcatheter prosthetic heart valve delivery devices including an inner shaft assembly having a coupling structure configured to selectively engage a prosthetic heart valve, a delivery sheath assembly having a capsule and slidably disposed over the inner shaft assembly, and an outer stability tube coaxially received over the delivery sheath assembly and having a compressible region. As the capsule is retracted, the capsule contacts a distal end of the outer stability tube and, with further proximal retraction of the capsule, force is applied by capsule to the distal end of the outer stability tube and eventually overcomes a biasing force of the compressible region, which causes the outer stability tube to retract along with the capsule allowing the outer stability tube to be longer and provider greater stability than if the compressible region were not present.