Cinching Anchor Implant for Precise Mitral Annulus Reshaping
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Solution Overview
Problem
Existing treatments for mitral regurgitation, such as annuloplasty rings, lack versatility and control in resizing the mitral valve annulus, and traditional delivery systems are cumbersome, posing safety risks.
Innovation Solution
A system comprising a catheter with a delivery device that deploys a cinching member connected anchors to reshape the valve annulus, allowing for precise resizing and symmetry, using a small delivery system suitable for transcatheter and trans-septal procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If traditional annuloplasty rings are used to treat mitral regurgitation, then the mitral annulus can be stabilized or resized, but the treatment lacks versatility and control in resizing precision
Solution Approach 1:
The implant is divided into multiple independently deployable anchors (first anchor, second anchor, third anchor, fourth anchor) that can be positioned at different locations around the valve annulus. Each anchor can be deployed and adjusted independently, enabling precise control over the resizing of different segments of the annulus while maintaining overall treatment versatility.
Solution Approach 2:
The cinching member is configured to be adjustable after deployment, allowing the anchors to be repositioned and the cinching tension to be modified. This dynamic adjustment capability enables precise control over the resizing process and allows the implant to adapt to patient-specific anatomical variations and treatment requirements.
2Reliability
If a small delivery system is used for transcatheter delivery, then safety is improved, but the device complexity increases
Solution Approach 1:
The delivery system employs a nested configuration where the implant components (anchors and cinching member) are contained within a catheter. The catheter itself can be nested within larger delivery apparatus, allowing the complex multi-anchor implant to be delivered through a relatively small transcatheter access route while maintaining delivery safety.
Solution Approach 2:
The implant is pre-assembled and pre-loaded into the delivery catheter in a compressed or nested state before patient administration. This preliminary preparation allows the complex device to be delivered through a small catheter without requiring complex manipulation during the actual delivery procedure, thereby maintaining safety while accommodating device complexity.
Data Source
AI summary
Aspects of the disclosure include bodily lumen reshaping and reduction systems, devices and methods. Such implants can include a plurality of anchors serially interconnected with a cinching member. Delivery devices of the disclosure are configured to deploy a first anchor into tissue. The delivery device can then deploy a second anchor and wind the cinching member around the second anchor to reduce a distance between the first and second anchors, placating the tissue between the anchors. Additional anchors can be similarly deployed and the cinching member can be similarly adjusted to reshape the lumen. Methods of deploying and reshaping a bodily lumen are also disclosed. In various examples, the bodily lumen is a heart valve, atrial appendage, portion of a gastrointestinal tract or urethra. Various embodiments include one or more anchors having a ratchet assembly or the like to substantially prevent the cinching member from unwinding.