Adjustable Tether Anchor System for Mitral Valve Repair
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Solution Overview
Problem
Native atrioventricular heart valves, such as the mitral valve, can become damaged, leading to structural alterations that result in ineffective closure and regurgitation flow from the ventricle to the atrium, limiting heart pump effectiveness.
Innovation Solution
An assembly comprising an active anchor with an abutment portion and a tether portion, an interventricular septal anchor, and a tether system that allows for adjustable length adjustments by relative rotation of the tether portion with respect to the abutment portion, enabling reshaping of cardiac chambers and repair of heart valves.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Shape
If a hoop ring is implanted to reinforce the annulus, then the annulus is returned to near the original shape, but the device complexity increases and the procedure becomes more invasive
Solution Approach 1:
The device is divided into separate components: a first anchor implanted in the ventricular wall, a second anchor implanted in the atrial wall, and a tensioning element connecting them. This segmentation allows for less invasive implantation compared to a complete hoop ring, while still achieving annular reinforcement and reshaping.
Solution Approach 2:
The invention extracts only the essential functional elements needed for annular reinforcement (anchors and tensioning element) rather than implanting a complete hoop ring structure. This reduces device complexity and invasiveness while maintaining the primary function of returning the annulus to its original shape.
2Ease of operation
If a clip is inserted via catheter to capture valve leaflets, then the procedure is less invasive, but the ability to adjust valve geometry is limited
Solution Approach 1:
The tensioning element is designed to be adjustable after implantation, allowing dynamic modification of the distance between anchors and thereby adjustment of valve geometry. This provides versatility comparable to more invasive procedures while maintaining the minimally invasive catheter-based delivery approach.
Solution Approach 2:
The invention enables changing of geometric parameters (distance between anchors, tension on the valve annulus) through adjustable tensioning elements. This allows customization of valve geometry to address specific patient needs while maintaining minimally invasive access.
3Reliability
If devices are implanted to bring heart chamber walls closer together, then valve closure is improved, but the device complexity and surgical difficulty increase
Solution Approach 1:
The device applies localized force at specific points (anchor implantation sites) rather than requiring global manipulation of heart chamber walls. This focuses the structural alteration where it is most needed, improving valve closure effectiveness while reducing overall device complexity and surgical difficulty.
4Device complexity
If the tether length is fixed, then the device structure is simpler, but the ability to adjust to patient-specific anatomy is reduced
Solution Approach 1:
The tether is designed with adjustable length capability, allowing it to be modified after implantation to achieve optimal tension and geometry for each patient's specific anatomy. This dynamic adjustment feature enhances adaptability while maintaining reasonable device complexity.
Solution Approach 2:
The invention enables changing of the tether length parameter to accommodate variations in patient anatomy and achieve optimal valve repair outcomes. This parameter adjustability is integrated into the device design in a manner that balances versatility with manageable complexity.
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 system effectively reshapes cardiac chambers and repairs heart valves by adjusting the distance between native heart structures, thereby improving valve closure and reducing regurgitation, enhancing the heart's pumping efficiency.
Implementation Method 1
a predetermined torque applied to the tether portion unlocks and causes a relative rotation of the tether portion with respect to the abutment portion, which rotation adjusts the first length of the working portion and the second length of the tether proximal portion
Data Source
AI summary
An implantable assembly adapted for reshaping a cardiac chamber of a heart includes an active anchor including an abutment portion adapted to abut against a wall of the chamber of the heart and a tether portion rotatably coupled to the abutment portion. The assembly further includes an interventricular septal anchor for coupling to a septum of the heart and a tether having a working portion having a first length, extending between the active anchor and the septal anchor, and a tether proximal portion having a second length. The abutment portion is releasably locked to the tether portion and configured such that a preselected torque applied to the tether portion of the active anchor unlocks and causes a relative rotation of the tether portion with respect to the abutment portion.