Mitral Valve Delivery Device Tether Control Alignment
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Solution Overview
Problem
Current methods for replacing mitral valves face challenges in accurately placing prosthetic valves with respect to axis, concentricity, and depth within the heart, leading to issues like turbulent blood flow and para-valvular leaks.
Innovation Solution
A delivery device with a handle, central elongate member, sheath, tether retainer, and tethers is used to deploy and position prosthetic mitral valves, featuring a tether control mechanism for precise expansion and alignment, ensuring proper placement by allowing self-expansion of anchors and controlled deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional surgical techniques are used for mitral valve replacement, then the procedure can be performed with established methods, but the placement precision of the prosthetic valve regarding axis, concentricity, and depth is compromised
Solution Approach 1:
The delivery device is divided into multiple functional components: a positioning system with alignment features, a deployment mechanism with controlled release, and a prosthetic valve with pre-formed anatomical geometry. This segmentation allows each component to contribute specifically to placement precision without requiring the entire system to be overly complex.
Solution Approach 2:
The delivery device acts as an intermediary tool that mediates between the surgeon's control and the prosthetic valve placement. It includes features like alignment guides and positioning mechanisms that ensure the valve is placed with correct axis, concentricity, and depth, thereby improving measurement precision while managing system complexity through dedicated intermediary components.
2Ease of operation
If the prosthetic valve is placed off-axis, then the placement procedure may be simpler, but turbulent blood flow and para-valvular leaks occur
Solution Approach 1:
The delivery device incorporates preliminary alignment features and positioning mechanisms that prevent off-axis placement before the valve is deployed. By establishing correct alignment during the implantation process itself, the system eliminates the need for post-implantation corrections and prevents harmful effects like turbulent flow and leaks from occurring in the first place.
3Ease of manufacture
If the prosthetic valve is placed off-center, then the deployment may be easier, but the heart's conductive system and neighboring valves are affected
Solution Approach 1:
The delivery device performs preliminary positioning actions to ensure the prosthetic valve is placed concentrically with the native valve annulus before final deployment. This preliminary alignment ensures that the valve center coincides with the annular center, preventing interference with the heart's conductive system and neighboring valves while maintaining deployment simplicity through pre-programmed positioning features.
4Productivity
If the prosthetic valve is placed at incorrect depth, then the implantation process may be faster, but interference with the conductive system occurs
Solution Approach 1:
The delivery device replaces manual depth estimation with mechanical depth control features, such as depth-stop mechanisms or pre-calibrated positioning systems. These mechanical features automatically ensure the valve is placed at the correct depth relative to the annular plane, preventing interference with the conductive system while maintaining implantation speed through automated depth control.
Data Source
AI summary
A delivery device includes a handle, a central elongate member extending from the handle, a sheath configured to slide over and relative to the central elongate member, a distal tether retainer at a distal end of the central elongate member, a proximal tether restraining mechanism positioned along the central elongate member distal of the handle and proximal of the distal tether retainer, and a plurality of tethers. The tethers are configured to extend from the proximal tether restraining mechanism to the distal tether retainer.