Annuloplasty Device Coronary Sinus Anchoring
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Solution Overview
Problem
Existing annuloplasty devices implanted in the coronary sinus for treating defective mitral valves face challenges in reshaping the annulus effectively while ensuring secure anchoring and minimizing trauma to the anatomy, often requiring complex procedures and frequent adjustments, which can be risky for patients.
Innovation Solution
A flexible elongate displacement unit with a proximal reversibly expandable portion and a distal anchoring portion, combined with a stent that is releasably connected to a delivery device, is inserted into the coronary sinus to modify the annulus shape, allowing for controlled downsizing and secure anchoring without causing trauma to the anatomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If prior art annuloplasty devices are implanted in the coronary sinus, then the annulus can be reshaped to treat defective mitral valves, but the procedure becomes complex and requires frequent adjustments increasing patient risk
Solution Approach 1:
The device is divided into distinct functional segments: a delivery catheter for minimally invasive insertion, an expandable frame that forms the annuloplasty structure, and anchoring mechanisms that secure the device. This segmentation allows each component to be optimized independently and simplifies the overall implantation procedure compared to monolithic prior art devices.
Solution Approach 2:
The device is pre-configured in a compressed state within the delivery catheter, allowing it to be delivered through minimal access routes. The expandable frame is prepared in advance with predetermined geometry that will automatically assume its functional shape upon deployment, eliminating the need for complex intra-procedural adjustments and reducing patient risk.
2Reliability
If the annulus is significantly reshaped to improve valve function, then valve performance is improved, but trauma to the coronary sinus anatomy increases
Solution Approach 1:
The expandable frame applies localized forces to specific portions of the annulus rather than uniform compression, allowing precise reshaping of the annular geometry where needed while leaving other areas undisturbed. The frame can be configured with varying cell sizes and shapes to address localized annular dilation or distortion, minimizing overall trauma to the coronary sinus.
Solution Approach 2:
The expandable frame transitions from a compressed delivery state to an expanded functional state, allowing the device to adapt to the patient's anatomy dynamically. This dynamic expansion enables the frame to conform to the native annular geometry and apply gentle, distributed forces that reshape the annulus over time without causing acute trauma to the coronary sinus walls.
3Duration of action of stationary object
If the displacement unit is made secure and anchored to retain the modified shape, then long-term functioning is ensured, but the risk of damaging the coronary sinus increases
Solution Approach 1:
The anchoring mechanisms are nested within the expandable frame structure, with anchors integrated into the frame's cells or positioned within the lumen of the coronary sinus. This nested configuration allows the anchors to secure the device firmly for long-term functioning while being contained within the overall device structure, preventing them from causing extraneous damage to the coronary sinus walls.
Solution Approach 2:
The expandable frame acts as an intermediary between the anchoring mechanisms and the coronary sinus anatomy. The frame distributes the anchoring forces over a larger surface area and mediates the interaction between the anchors and the vessel wall, reducing point-load trauma while ensuring secure long-term anchoring for sustained valve function.
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 solution provides long-term functioning of the mitral valve with less complex procedures, improved control over downsizing, reduced risk of damaging the coronary sinus, and atraumatic engagement, ensuring secure anchoring and minimizing long-term negative effects.
Implementation Method 1
a proximal reversibly expandable portion being reversibly foldable to an expanded state for positioning against a tissue wall at the entrance of the CS
Implementation Method 2
a stent arranged around the displacement unit and being movable relative the displacement unit along the longitudinal direction for insertion into the CS
Data Source
AI summary
An annuloplasty device is disclosed comprising a removable and flexible elongate displacement unit insertion into a coronary sinus (CS) adjacent the mitrel valve, a proximal reversibly expandable portion being reversibly foldable to an expanded state for positioning against a tissue wall at the entrance of the CS, a distal anchoring portion being movable in relation to the proximal expandable portion in a longitudinal direction of the displacement unit to an activated state in which the shape of the annulus is modified to a modified shape, a stent arranged around the displacement unit and being movable relative the displacement unit along the longitudinal direction for insertion into the CS, and wherein the stent is releasably connected to a delivery device and arranged radially between the displacement unit and the proximal expandable portion in a radial direction.