Spool Assembly for Transcatheter Mitral Valve Repair
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Solution Overview
Problem
Current methods for repairing mitral regurgitation due to ischemic heart disease, such as those involving chordae tendineae and valve leaflet coaptation, face challenges in accurately adjusting tension and length during transcatheter procedures, often resulting in suboptimal leaflet coaptation and ventricular wall restoration.
Innovation Solution
The development of an apparatus with adjustable repair chords and a spool assembly that can be slidably advanced along a guide wire, featuring docking stations and a reversible locking mechanism, allows for bidirectional tensioning and relaxation of the repair chords, enabling precise adjustment of chordae tendineae tension and leaflet coaptation during transcatheter procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If current methods for repairing mitral regurgitation are used, then the procedure can be performed, but accurate adjustment of tension and length is difficult resulting in suboptimal leaflet coaptation
Solution Approach 1:
The repair chord assembly incorporates a spool assembly that allows dynamic adjustment of the repair chord length and tension after implantation. The spool can be rotated to wind or unwound to slacken the chord, enabling bidirectional adjustment to achieve optimal leaflet coaptation without requiring precise pre-setting of tension.
Solution Approach 2:
A guide wire serves as an intermediary element that facilitates the advancement and positioning of the rotation assembly to the implantation site. The guide wire enables controlled delivery and positioning of the complex spool and repair chord assembly through the heart wall, making the procedure more manageable despite its complexity.
2Manufacturing precision
If a rotation assembly with spool is used, then precise adjustment of repair chord tension is enabled, but the device complexity increases
Solution Approach 1:
The spool assembly serves multiple functions: it acts as a tensioning mechanism, a length adjustment mechanism, and a locking mechanism (when combined with the locking element). This multi-functionality consolidates what would otherwise require separate components into a single integrated assembly, reducing overall device complexity while maintaining precise adjustment capabilities.
Solution Approach 2:
The rotation assembly is nested within a delivery catheter that is advanced through the vasculature to the implantation site. The spool and repair chord assembly are contained within the catheter during delivery, simplifying the procedural steps and reducing the complexity of handling multiple separate components during the procedure.
3Reliability
If the rotation assembly is advanced to the implantation site, then proper valve closure can be achieved, but the procedure requires complex delivery mechanisms
Solution Approach 1:
The guide wire acts as an intermediary that simplifies the delivery process by providing a tracked pathway for advancing the rotation assembly. The guide wire is first positioned through the heart wall to the implantation site, then the rotation assembly is advanced over the guide wire, eliminating the need for complex self-contained delivery mechanisms and improving reliability of placement.
Data Source
AI summary
Apparatus is provided for use with at least one tissue-adjustment device, including a tissue-engaging element having a distal portion configured to engage at least a first portion of tissue of a patient, and having a proximal portion. At least one docking station is coupled to the proximal portion of the tissue-engaging element and is configured to be coupled to the at least one tissue-adjustment device. The docking station includes a locking mechanism configured to lock the tissue-adjustment device to the tissue-engaging element. At least one guide member is reversibly coupled to the at least one docking station and is configured for facilitating slidable advancement of the at least one tissue-adjustment device toward the tissue-engaging element. Other applications are also described.