Mitral Valve Annulus Shortening with Braced Tether Anchors
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Solution Overview
Problem
Existing methods for reshaping the mitral valve to improve closure and reduce mitral regurgitation are complex and invasive, requiring multiple steps and instruments for implantation, which complicates the procedure and may not ensure secure anchor placement.
Innovation Solution
A system comprising two screw-type tissue anchors linked by a tether with bracing structures and a cushioning sleeve, delivered via catheter instrumentation, to maintain anchor alignment and secure tissue attachment, reducing invasiveness and procedural complexity by integrating cinch and bracing functions for precise spacing and stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple separate instruments and steps are used for implantation, then anchor placement can be achieved, but the procedure becomes complex and invasive
Solution Approach 1:
The patent combines multiple functions (cinching, bracing, anchoring) into a single integrated apparatus. The tether structure incorporates both cinch features for shortening and bracing features for stabilization, eliminating the need for separate instruments and reducing procedural complexity while maintaining anchor placement security
Solution Approach 2:
The tether structure serves multiple functions simultaneously: it acts as a cinch structure for shortening distance between anchors, a bracing structure for preventing tip-over, and a delivery mechanism for anchors. This multi-functionality reduces the number of separate components needed and simplifies the overall implantation procedure
2Manufacturing precision
If tether tension is applied to shorten mitral valve annulus, then valve closure improves, but anchor tip-over toward each other occurs
Solution Approach 1:
The bracing features are designed to preemptively counteract the tip-over force generated by tether tension. The bracing structures extend along the tether and provide opposing moments that prevent anchor rotation before tip-over can occur, allowing the tether to effectively shorten the annulus without compromising anchor orientation
Solution Approach 2:
The bracing structures create counter-moments that balance the tipping moment generated by tether tension. By providing an opposing rotational force, the bracing features stabilize the anchor orientation while allowing the tensile force to effectively shorten the mitral valve annulus
3Adaptability or versatility
If multiple separate delivery steps are used, then each component can be optimized, but the number of invasive steps increases
Solution Approach 1:
The cinch structure and bracing structure are combined into a single integrated tether assembly that can be delivered in one continuous motion. This merging maintains the functional advantages of separate optimized components while eliminating the need for multiple delivery steps and reducing procedural complexity
Data Source
AI summary
An implant structure for use in pulling two soft body tissue areas closer together in a patient (e.g., two points along or adjacent to the patient's mitral valve annulus) includes at least two tissue anchor structures that are respectively implantable into the two tissue areas. A tether structure links the two tissue anchors and can be shortened and held in that condition by a cinch structure. Bracing structures are used between the anchors and the tether to help keep the longitudinal axes of the anchors transverse to the tether axis even when the tether is under tension. The tether may be sheathed in a cushioning sleeve to help protect adjacent tissue from erosion by the tether.