Segmented Mitral Valve Annulus Reshaping Device
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Solution Overview
Problem
Current treatments for mitral valve regurgitation, such as annuloplasty rings, often cause rigidity or scar tissue formation, leading to loss of flexibility and function in the mitral valve, and require invasive surgical procedures or suturing, which can result in complications and prolonged recovery.
Innovation Solution
A device with radially extending legs that can be deployed to reshape the mitral valve annulus by shortening, allowing for improved coaption of the valve leaflets without the need for suturing, using a delivery catheter for minimally invasive placement and made from biocompatible materials like shape-memory alloys or superelastic metals.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If rigid annuloplasty rings are used to reduce annulus size, then regurgitation is corrected, but the mitral valve loses flexibility and cannot flex in response to ventricular contractions
Solution Approach 1:
The device is divided into multiple independent legs (typically 6-8 legs) that are distributed around the mitral valve annulus. Each leg can independently engage the annulus tissue and apply localized reshaping force, allowing the overall structure to maintain flexibility while achieving effective annulus reduction. This segmentation avoids the rigidity problem of traditional continuous annuloplasty rings.
Solution Approach 2:
The device incorporates adjustable leg length through telescoping mechanisms or shape-memory alloy properties, allowing the structure to dynamically adapt to ventricular contraction cycles. The legs can flex and move with the natural motion of the heart, maintaining valve flexibility while providing consistent annulus reshaping force throughout the cardiac cycle.
2Adaptability or versatility
If flexible annuloplasty rings made of Dacron fabric are used, then valve flexibility is maintained, but multiple sutures are required causing scar tissue formation and loss of function
Solution Approach 1:
The invention completely removes the suturing step from the implantation process. The legs are designed with self-retaining features such as barbs, hooks, or expansion mechanisms that allow them to securely engage the annulus tissue without requiring any sutures. This extraction of the suturing operation eliminates the source of scar tissue formation while maintaining effective annulus reshaping.
Solution Approach 2:
The device performs its own anchoring function through self-expanding or self-locking leg mechanisms that automatically secure to the annulus tissue upon deployment. The legs utilize the natural tissue elasticity and mechanical interlocking features to achieve stable fixation without external suturing assistance, thereby preventing scar tissue formation from multiple stitch sites.
3Ease of manufacture
If combination rigid and flexible annuloplasty rings are inserted into the atrioventricular groove, then suturing is avoided, but tissue damage to the heart must be prevented during placement
Solution Approach 1:
The device uses a delivery catheter system as an intermediary to guide and position the legs precisely at the mitral valve annulus. The catheter provides a controlled pathway that prevents random tissue damage during insertion, allowing the legs to be deployed exactly where needed on the annulus surface without requiring insertion into the atrioventricular groove or risking damage to surrounding cardiac structures.
Solution Approach 2:
The legs are designed to engage only the annulus tissue at specific localized points around the mitral valve, leaving the rest of the cardiac tissue undisturbed. This localized engagement approach avoids the need for broad insertion into the atrioventricular groove, minimizing the risk of tissue damage while achieving effective annulus reshaping at the precise target location.
4Reliability
If open-heart surgery is performed for valve replacement or repair, then regurgitation can be corrected, but the procedure is complex, invasive, and requires long recovery
Solution Approach 1:
The invention replaces complex open-heart surgical mechanical procedures with a minimally invasive catheter-based delivery system. The device is inserted through a peripheral vessel or small incision and deployed using balloon expansion or self-expanding mechanisms, eliminating the need for sternotomy, cardiopulmonary bypass, and complex surgical manipulation of the valve structures. This substitution dramatically reduces procedural complexity and invasiveness while maintaining effective regurgitation correction.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device effectively alters the shape of the mitral valve annulus to improve leaflet coaption, reducing regurgitation and avoiding the complications associated with traditional treatments, while allowing for minimally invasive procedures and reduced recovery time.
Implementation Method 1
made from biocompatible materials like shape-memory alloys or superelastic metals
Implementation Method 2
made from biocompatible materials like shape-memory alloys or superelastic metals
Data Source
AI summary
A device, a system and a method for treating heart valve regurgitation. The annulus reshaping device comprises a base and a plurality of legs radially arranged there upon. The device can transform from a delivery configuration wherein it is deliverable by catheter to a treatment site, into a deployment configuration, and then a treatment configuration for treating valvular regurgitation. The device is implanted into the annulus of a heart valve, and the legs of the device can be telescopically withdrawn to apply an inward force to the annulus. The system comprises a device slidably received within a catheter. The method of treatment comprises delivering a device to a treatment area, via catheter, releasing the device from the catheter, positioning the legs of the device on a valve annulus, and applying an inward force to the annulus to reduce the regurgitation.


