Mitral Valve Treatment Device Annular Support
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Solution Overview
Problem
Current methods for treating mitral valve regurgitation, such as valve replacement and annuloplasty, have limitations in effectively preventing retrograde flow and prolapse, and there is a need for innovative approaches to address the complex anatomy and function of the mitral valve.
Innovation Solution
A mitral valve treatment device comprising a band with distal and proximal coupling elements that are placed around the mitral valve, specifically coupling to chordae tendineae to tighten the annulus, or an inflatable band that applies pressure to the posterior cusp and chordae tendineae, or a stent that expands to apply pressure, thereby addressing regurgitation by altering the valve's anatomy and function.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If valve replacement is performed to treat mitral valve regurgitation, then regurgitation is prevented, but surgical complexity and patient risk increase
Solution Approach 1:
The patent introduces an intermediary device (annuloplasty ring or band) that mediates between the defective native valve and the desired functional outcome. This intermediary structure provides annular support and geometric correction without requiring complete valve replacement, thereby reducing surgical complexity while maintaining reliability in preventing regurgitation.
Solution Approach 2:
The patent applies local quality by providing targeted annular reinforcement only at the specific regions where geometric distortion occurs. The annuloplasty device can be configured to provide differential support at different segments of the annulus, addressing localized pathology while preserving the native valve structure and reducing overall surgical complexity.
2Strength
If a mechanical support ring is implanted to strengthen the valve annulus, then annular strength is improved, but device complexity and procedural difficulty increase
Solution Approach 1:
The patent divides the annuloplasty device into segmented or modular components that can be independently positioned and secured to the annulus. This segmentation allows the device to achieve overall annular strength while simplifying the implantation process, as each segment can be placed and secured separately rather than requiring complete device installation in a single complex step.
Solution Approach 2:
The patent employs flexible annular bands or films that can conform to the native annular geometry while providing the necessary structural support. These flexible structures achieve annular strength through their material properties and geometric configuration rather than through complex rigid mechanical constructions, thereby reducing device complexity.
3Reliability
If anchors are drawn together to tighten the annulus, then regurgitation is reduced, but the complexity of anchor deployment and tensioning increases
Solution Approach 1:
The patent extracts the tensioning function from the anchor deployment process by using pre-tensioned sutures or self-tightening mechanisms. The anchors are deployed independently to secure the annuloplasty device, while the tightening action is achieved through separate, simpler mechanisms such as knotting pre-tensioned sutures or utilizing elastic recoil, thereby reducing the complexity of coordinating anchor deployment with tensioning.
Solution Approach 2:
The patent implements self-service by designing anchors or associated structures that automatically tighten or secure themselves upon deployment. For example, self-tightening sutures or elastic bands that automatically apply tension when the annulus is constricted, eliminating the need for complex external tensioning mechanisms and reducing procedural complexity.
4Reliability
If the mitral valve anatomy is altered to improve coaptation, then regurgitation is reduced, but the risk of affecting valve function and causing complications increases
Solution Approach 1:
The patent applies partial action by providing annular support only at the specific regions where geometric distortion contributes to regurgitation, rather than uniformly altering the entire annulus. This selective approach improves coaptation where needed while minimizing alterations to normal valve anatomy and reducing the risk of complications from excessive or inappropriate geometric changes.
Solution Approach 2:
The patent employs preliminary action by pre-shaping the annuloplasty device to match the desired target annular geometry before implantation. This pre-forming ensures that when the device is implanted, it gently guides the annulus toward the target configuration rather than forcing abrupt geometric changes, thereby reducing the risk of tissue damage and complications while achieving the desired coaptation improvement.
Data Source
AI summary
A method is provided, including treating a heart valve of a patient by implanting at the heart valve an implant including an elongate element including at least in part a tension element, by placing the implant at the heart valve of the patient, and subsequently to the placing, increasing tension of the elongate element at least in part. The tension element is configured to undergo conformational changes, subsequently to the placing, responsively to a cardiac cycle of the patient. Implanting the implant includes implanting the implant such that the tension element undergoes the conformational changes responsively to the cardiac cycle of the patient in a manner in which the tension element cyclically increases and decreases pressure applied to at least one leaflet of the heart valve by the elongate element.