Replacement Heart Valve Docking Deployment for Mitral Sealing
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Solution Overview
Problem
Existing technologies face challenges in replacing mitral valves minimally invasively due to difficulties in anchoring prosthetic valves effectively, particularly due to the non-circular shape and anatomical variations of the mitral annulus, which can lead to valve misalignment, leaks, and potential damage to the heart tissue.
Innovation Solution
The use of anchoring or docking devices, such as coiled or helical anchors, that create a more circular docking site at the native valve position, allowing for secure implantation of prosthetic valves through transcatheter methods, using delivery systems with pusher tools for precise placement and stabilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional anchoring methods are used for mitral valve replacement, then the procedure can be performed with simpler devices, but the valve may become misaligned or leak due to the non-circular shape of the mitral annulus
Solution Approach 1:
The anchoring device is divided into multiple independent elements including a delivery catheter, expandable frame, anchoring arms, and valve prosthesis. These segmented components are delivered separately and assembled in situ, allowing each component to be optimized for its specific function while collectively solving the alignment and sealing challenges of the non-circular mitral annulus
Solution Approach 2:
The expandable frame is designed with a circular or substantially round configuration that contrasts with the non-circular mitral annulus shape. This circular geometry provides a stable, predictable structure for valve alignment and sealing, while the ability to expand from a compressed state allows adaptation to the irregular annular geometry through controlled deformation
2Object-affected harmful factors
If minimally invasive transcatheter methods are used, then patient trauma is reduced, but precise placement and stabilization of the prosthetic valve becomes more difficult
Solution Approach 1:
The delivery catheter is pre-configured with the compressed expandable frame and valve prosthesis assembly before patient intervention. Radiopaque markers and alignment features are pre-positioned on the device components to guide precise placement. The entire assembly is prepared in advance for delivery through the catheter, enabling accurate positioning through imaging guidance while maintaining minimal invasiveness
Solution Approach 2:
Radiopaque markers are integrated into the device components to provide real-time visual feedback during deployment through fluoroscopic imaging. This allows the operator to monitor the expansion and positioning of the frame and valve prosthesis, making adjustments as needed to achieve precise placement and stabilization while maintaining minimally invasive access
3Ease of manufacture
If the mitral annulus is replaced with a circular docking site, then prosthetic valve implantation is simplified, but the native heart tissue structure is altered
Solution Approach 1:
The expandable frame serves as an intermediary structure between the native non-circular mitral annulus and the circular prosthetic valve prosthesis. This intermediate component creates a circular docking site that simplifies valve implantation while being supported by and attached to the native annular tissue, effectively mediating the geometric transition without requiring direct replacement of the native annulus structure
Solution Approach 2:
The natural mechanical function of the non-circular mitral annulus is substituted by an artificial expandable frame with circular geometry. This mechanical substitution provides a more regular, predictable structure for valve support while the frame can be anchored to and distributed across the native annular tissue, replacing the geometric function rather than the entire mechanical system
4Stability of the object's composition
If anchoring devices are deployed to secure the valve, then valve stability is improved, but risk of damage to heart tissue increases
Solution Approach 1:
The anchoring arms and frame structure are designed with flexible, compliant materials that can deform and conform to the native heart tissue geometry. This flexibility allows the anchoring elements to engage the tissue gently without rigid piercing or cutting, distributing anchoring forces across a larger area to prevent focal tissue damage while maintaining valve stability
Solution Approach 2:
The expandable frame structure is designed to distribute anchoring forces across multiple attachment points around the annulus rather than concentrating force at single piercing points. This distributed force distribution acts as a cushioning mechanism that reduces peak stresses on the native tissue, preventing damage while achieving stable valve anchoring
Data Source
AI summary
Systems and methods usable in delivering a prosthetic implant to a patient's heart. A distal region of a delivery catheter can be positioned in an atrium of the heart and a distal tip can be positioned at or near a commissure of the native valve. The prosthetic implant can be located within the delivery catheter. A pusher tool can be advanced distally through the delivery catheter to push the docking device along within the delivery catheter. The docking device can be connected to the pusher tool by a line, such as a suture. A member of the pusher tool can be rotatable to change the amount of the suture extending from the pusher tool.