Retrieval Device and Sealing Canopy for Mitral Valve
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Solution Overview
Problem
Current transcatheter heart valve replacement technologies face challenges with retrieval of collapsible prosthetic valves, insufficient articulation and sealing within the native annulus, pulmonary edema due to poor atrial drainage, perivalvular leaking, and lack of customization, particularly for the mitral valve, which complicates the procedure and increases morbidity and cost.
Innovation Solution
A prosthetic heart valve retrieval apparatus with a handle, actuator, tensioning unit, traveller strap, and catheter system that allows for the capture and retraction of tethers to collapse and remove the expandable stent, along with a sealing canopy design featuring a passively oscillating dome-shaped sealing canopy and stent-in-a-stent configuration to enhance sealing and reduce leaking.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a collapsible prosthetic heart valve is used for transcatheter replacement, then the procedure becomes less invasive and morbidity is reduced, but retrieval capability is lost and device removal becomes impossible
Solution Approach 1:
The stent is designed with dynamic properties allowing it to transition between expanded and collapsed states. The stent includes features such as radial bars with articulation points that enable controlled collapse when retrieval is needed, while maintaining structural integrity during normal operation. This dynamic design allows the device to be retrievable without compromising its initial less-invasive benefit.
Solution Approach 2:
The stent structure is divided into multiple segments or radial bars that can move independently. This segmentation allows the stent to collapse in a controlled manner for retrieval while maintaining its expanded shape for proper valve function. The modular design enables the stent to be compressed into the delivery catheter for implantation and then expanded at the target site, with the option to recollapse for retrieval if necessary.
2Device complexity
If traditional sealing structures are used in prosthetic heart valves, then the design is simpler, but perivalvular leaking and insufficient sealing within the native annulus occur
Solution Approach 1:
The sealing system employs a nested configuration where an inner sealing structure is positioned within an outer sealing structure. The inner seal addresses leakage at one level while the outer seal provides additional protection at another level. This multi-layered nested sealing approach enhances sealing effectiveness and reduces perivalvular leaking without requiring excessive complexity in any single sealing component.
Solution Approach 2:
The sealing structures are designed with varying properties at different locations to address specific leakage patterns. The seals include features such as flared ends, articulating collar support structures, and varying material compositions tailored to local anatomical conditions and pressure distributions. This localized optimization of sealing properties improves overall sealing effectiveness while maintaining reasonable design complexity.
3Ease of operation
If a fixed-size prosthetic valve is implanted, then the implantation procedure is simpler, but customization for different patient anatomies is limited and perivalvular leaking increases
Solution Approach 1:
The stent and valve assembly incorporate dynamic adjustment mechanisms that allow the device to adapt to different anatomical configurations. The stent includes articulation points and flexible segments that enable the valve to conform to the native annulus shape and size variations. This dynamic adaptability allows a single device design to serve multiple patient anatomies without compromising implantation simplicity.
Solution Approach 2:
The valve system allows for parameter adjustments in terms of stent expansion ratio, collar articulation angles, and sealing structure configuration to match different patient anatomies. These parameter changes enable customization of the implant to fit various annulus sizes and shapes while maintaining a relatively simple implantation procedure that does not require complex sizing calculations or multiple device options.
Data Source
AI summary
This invention relates to the design and function of a device which allows for retrieval of a previously implanted valve prosthesis from a beating heart without extracorporeal circulation using a transcatheter retrieval system, including a guide component to facilitate the compression of the valve and retraction into a retrieval catheter, as well as an improved prosthetic transcatheter heart valve having one or more of: a series of radially extending tines having a loop terminus to improve sealing a deployed prosthetic mitral valve against hemodynamic leaking, a pre-compressible stent-in-stent design, or an articulating cuff attached to a covered stent-valve and a commissural sealing skirt structure attached to the underside of the articulating cuff.