Prosthetic Heart Valve Delivery Tether Notched Wire
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods for delivering and positioning prosthetic heart valves are invasive, cumbersome, and often disrupt native valve functionality, particularly in single-chamber solutions, due to the need for bulky 2-chamber systems and invasive anchoring, which complicates recapturing and repositioning of expandable stents within the heart chamber.
Innovation Solution
A delivery system featuring a self-expanding stent frame with a tether assembly, including a notched wire and outer tube, allows for loading, collapsing, translating, repositioning, and deploying the stent within the heart chamber using a push/pull and release mechanism, enabling easier attachment and detachment from the stent frame for minimally invasive procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a self-expanding stent frame is used for prosthetic heart valve delivery, then the valve can be positioned and held in place within the heart chamber, but the device becomes difficult to recapture and reposition if initial positioning is incorrect
Solution Approach 1:
The stent frame is designed with dynamic expandability, transitioning from a compressed delivery state to an expanded deployed state. This dynamic property allows the stent to be easily recaptured and repositioned before final deployment, while providing stable positioning once deployed. The notched wire attachment feature enables controlled engagement and disengagement of the stent from the delivery catheter, facilitating repositioning if needed.
Solution Approach 2:
The delivery system incorporates preliminary positioning capabilities with the notched wire attachment mechanism that allows the stent to be temporarily held in various positions during delivery. The operator can make preliminary positioning adjustments before final deployment, and if positioning is incorrect, the stent can be recaptured and repositioned using the same attachment mechanism before committing to final placement.
2Reliability
If traditional delivery methods are used for prosthetic heart valves, then the valve can be delivered to the heart chamber, but the procedures are invasive and cumbersome requiring extended hospitalization and painful recovery
Solution Approach 1:
The delivery system is segmented into distinct functional components: a delivery catheter, a notched wire attachment mechanism, and the stent frame with integrated attachment features. This segmentation allows for minimally invasive percutaneous delivery through the catheter, avoiding open heart surgery. The modular design enables the valve to be delivered through a small incision while maintaining effective deployment capability.
3Reliability
If 2-chamber systems are used for prosthetic heart valve replacement, then the valve can be supported and positioned, but the systems are bulky and disrupt native valve functionality
Solution Approach 1:
The invention extracts and eliminates the need for bulky 2-chamber support systems by integrating the positioning and support functions directly into a self-expanding stent frame that can be delivered through a minimally invasive catheter. The stent frame itself provides the necessary structural support without requiring additional external support structures, thereby reducing system bulk and preserving native valve functionality where possible.
4Reliability
If the stent frame is designed for self-expansion to assist positioning, then the valve can be held in position within the heart chamber, but recapturing the device requires difficult re-collapsing of the expanded stent
Solution Approach 1:
The stent frame exhibits dynamic mechanical properties, being capable of transitioning between compressed and expanded states. The self-expansion mechanism is designed to provide stable positioning when expanded, while the attachment mechanism to the delivery catheter allows for controlled recapture and re-compression if repositioning is needed before final deployment.
Data Source
AI summary
Systems, devices and methods for attaching an operator-manipulatable tether(s) to the stent for: loading and/or collapsing the expandable stent into a delivery catheter or sheath, translating the collapsed stent along the delivery catheter or sheath, delivering the expandable stent into the subject heart chamber, repositioning the expandable stent as necessary within the subject heart chamber, recapturing or resheathing the expandable stent within the delivery catheter or sheath if needed, and deploying the expandable stent to, and within, the subject heart chamber.