Lockable Cinching Mechanism for Mitral Annulus Stabilization
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Solution Overview
Problem
Current annuloplasty devices face challenges in effectively reducing and reshaping valve annuli to treat valve regurgitation, particularly in stabilizing the mitral annulus without reducing its circumference, and in maintaining the position of implants during the treatment process.
Innovation Solution
A delivery system comprising tubular members with cinching lines and locks that allow for the reshaping and stabilization of valve annuli, utilizing a catheter with lumens and locks that transition from an open to a closed configuration to secure the cinching lines and maintain the implant's position around the annulus.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an annuloplasty ring is placed on the mitral annulus to reduce circumference, then mitral regurgitation is treated, but the implant position cannot be maintained during the treatment process
Solution Approach 1:
The lockable cinching mechanism is nested within the delivery catheter system. The cinching line passes through the delivery catheter, and the lock mechanism is contained within the catheter lumen during delivery. Upon deployment, the lock engages to secure the cinched annuloplasty ring position, maintaining reliability while managing device complexity through integrated nesting.
Solution Approach 2:
The cinching line is pre-positioned through the annuloplasty ring and delivery catheter before implantation. The lock mechanism is prepared in advance within the catheter, allowing for controlled deployment and immediate position stabilization once the ring is placed on the annulus, ensuring position stability is achieved as part of the initial implantation action.
2Manufacturing precision
If a delivery system is used to place an annuloplasty ring, then precise positioning is achieved, but the system complexity increases
Solution Approach 1:
The delivery system employs a nested structure where the annuloplasty ring is delivered within a catheter, and the lockable cinching mechanism is nested within the catheter lumen. This integrated nesting approach enables precise positioning through the catheter delivery path while managing system complexity by containing multiple functions within a unified delivery architecture.
3Reliability
If locks are used to secure the cinching line, then the implant position is maintained, but the device complexity increases
Solution Approach 1:
The lock mechanism is designed to automatically engage and secure the cinching line upon deployment from the catheter. The self-actuating nature of the lock reduces the need for complex manual operation mechanisms, maintaining reliable position maintenance while minimizing the added device complexity through self-service functionality.
Data Source
AI summary
Aspects of the disclosure include systems and devices for delivering an implant to a bodily annulus, such as an annuloplasty implant to a heart valve annulus. Various implants of the disclosure include one or more cinching lines extending through respective flexible tubular members, which are anchored to the annulus. The cinching lines can be tensioned to reshape the annulus. Systems further include least one lock to maintain the position of the cinching lines. Methods of reshaping the implant and locking a position of the reshaped implant are also disclosed.