Mitral Valve Annulus Reshaping via Segmented Anchor System
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current mitral valve annuloplasty techniques face challenges such as invasive procedures, risks of morbidity and mortality, device migration, fracture, and embolic risks due to implant size and shape, which affect the efficacy of restoring mitral valve competence.
Innovation Solution
A system comprising a catheter with a frame and anchors that can be deployed to reshape the mitral valve annulus, featuring a cinch mechanism and guidance device to form conjoined anchor pairs, reducing the implant's profile and enhancing flexibility and retention, thereby minimizing migration and embolic risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional annuloplasty ring is used, then the valve annulus can be restored to its native configuration, but the procedure becomes invasive and time-consuming with risks of morbidity and mortality
Solution Approach 1:
The implant is divided into multiple individual anchors distributed around the valve annulus, each anchor independently engaging the tissue. This segmentation allows for less invasive delivery while maintaining the structural support needed to restore the annulus configuration
Solution Approach 2:
The anchors are nested within a delivery catheter in a compressed state, allowing them to be delivered percutaneously through a minimally invasive approach. Once deployed, the anchors expand from the nested configuration to their functional shape, restoring the valve annulus without requiring open surgery
2Reliability
If current valve annulus implants are used, then the valve annulus can be reshaped, but the implants are subject to migration and device fracture
Solution Approach 1:
The implant consists of multiple discrete anchors rather than a single continuous ring. Each anchor independently engages the tissue, distributing mechanical stresses and preventing the device from migrating as a unit. This segmentation also eliminates weak points where fracture could occur in continuous rings
Solution Approach 2:
Each anchor is designed with specific local characteristics including tissue-penetrating elements for secure engagement and flexible bodies for stress distribution. The anchors are positioned at specific locations around the annulus where they provide localized support while collectively maintaining the overall annular geometry
3Reliability
If large sized implants are used, then the valve annulus can be supported, but the implant projects into the atrium causing embolic risk and thrombus formation
Solution Approach 1:
The support function is distributed across multiple small anchors rather than a single large implant. Each anchor is small enough to not project significantly into the atrium, eliminating the embolic risk associated with large continuous rings while collectively providing sufficient support for the valve annulus
Solution Approach 2:
The anchors are designed with smooth surfaces and streamlined shapes at their atrial-facing portions to minimize turbulence and blood stasis. The tissue-engaging portions are localized to specific depths, ensuring that the anchors provide structural support without creating large protrusions into the blood flow path
4Reliability
If anchors are driven into tissue at normal angles, then the anchors can engage the tissue, but the implant profile remains large and inflexible
Solution Approach 1:
Instead of driving anchors perpendicular to the annular plane, the anchors are driven at oblique angles that are inverted relative to the traditional approach. This allows the anchors to engage the tissue securely while their bodies follow a curved path that reduces the overall implant profile and increases flexibility
Solution Approach 2:
The anchors are positioned at multiple angular orientations around the annulus rather than all in a single plane. This three-dimensional arrangement reduces the projected profile of the implant and allows greater flexibility in accommodating the natural motion of the heart while maintaining secure tissue engagement
Data Source
Figure 1
Figure 2
Figure 3A~4
AI summary
A valve annulus repair system joins anchors at one or both of their proximal and distal ends to construct an implant to reshape the annulus. A removable frame may be used to position the anchors proximate to the annulus and to adjust the shape of the annulus. The frame may support the anchors during deployment of the system, release the anchors during construction of the implant, adjust the shape of the implant (and concomitantly the shape of the reconstructed valve) during an adjustment/cinching process, retain the adjusted shape of the valve annulus while relative anchor positions are secured, and release the anchors to enable the frame to be removed from the deployment site following implant construction. With such a system, a low-profile, flexile annular valve implant with reduced the risks of migration, fracture, embolism and thrombus may be provided.