Two-Step Prosthetic Heart Valve Delivery System
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Solution Overview
Problem
Current methods for delivering and positioning prosthetic heart valves are inefficient, particularly in achieving precise positioning and recapture, and often require invasive procedures that disrupt native valve functionality and cause unnecessary trauma, with 2-chamber solutions being bulky and difficult to deliver and position.
Innovation Solution
A two-step delivery and implantation system using a collapsible self-expanding frame anchored in the left atrium, with a prosthetic mitral valve delivered and connected via a snap-in mechanism or zip tie, allowing for supplementation or replacement of native valve functionality without engaging the left ventricle or native valve leaflets, thus minimizing interference and trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a self-expanding stent or wire network is used to support the replacement valve, then the valve can be positioned and held in position within the heart chamber, but the device becomes difficult to recapture and reposition if initial positioning is incorrect
Solution Approach 1:
The delivery system is divided into two independent components: a collapsible delivery catheter and a self-expanding valve assembly. This segmentation allows the valve to be delivered in a compressed state through the catheter, deployed when needed, and recaptured by re-engaging the catheter with the valve's recapture features without requiring full collapse of the self-expanding structure.
Solution Approach 2:
The delivery catheter is designed with preliminary positioning features that engage with the self-expanding valve before full deployment. This preliminary engagement allows for initial positioning adjustments and recapture operations while the valve is in a partially deployed state, before final anchoring occurs.
2Reliability
If a 2-chamber solution is used for valve replacement, then the valve can be fully supported and anchored, but the device becomes bulky and difficult to deliver and position
Solution Approach 1:
The self-expanding valve is nested within a collapsible delivery catheter in a compact configuration for delivery. Once positioned, the valve self-expands to its full functional size while the catheter collapses and is withdrawn. This nesting approach allows a large functional device to be delivered through a small access catheter.
Solution Approach 2:
The delivery system transitions from a static compact delivery configuration to a dynamic deployed configuration. The self-expanding valve changes from a compressed state during delivery to an expanded anchored state during operation, allowing the device to be small during delivery but large during function.
3Reliability
If invasive procedures are used for valve replacement, then the valve can be securely implanted, but native valve functionality is disrupted and trauma is caused
Solution Approach 1:
The collapsible delivery catheter serves as an intermediary that guides and positions the self-expanding valve without requiring direct manipulation or disruption of the native valve structures. The catheter delivers the replacement valve through a minimally invasive transvenous approach, avoiding direct contact with and trauma to the native valve leaflets and annulus.
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
Enables efficient and minimally invasive delivery and positioning of prosthetic heart valves that can supplement or replace native valve functionality, reducing trauma and maintaining native valve functionality, with the ability to fully replace the native valve when necessary, while avoiding the bulkiness and invasive anchoring issues of 2-chamber solutions.
Implementation Method 1
a collapsible self-expanding frame anchored in the left atrium
Data Source
AI summary
A two-step delivery method, system and device is disclosed comprising, in various embodiments, a self-expanding frame. A self-expanding frame is delivered and expanded within a heart chamber followed by delivery of a prosthetic valve comprising prosthetic valves thereon into the expanded self-expanding frame, which is in turn connected to a valve connection region defined on and by the delivered and expanded frame.