Differentially Deformable Anchoring for Transcatheter Heart Valve Alignment
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Solution Overview
Problem
Current treatments for atrioventricular valve insufficiency, such as mitral and tricuspid valve regurgitation, are invasive and have limitations like outflow tract obstruction, thrombus formation, and unfavorable outcomes, leaving a significant population of patients without effective minimally invasive transcatheter valve therapies.
Innovation Solution
A prosthetic heart valve device and delivery system that can be radially compressed for transcatheter delivery and expanded for secure implantation within deficient atrioventricular valves, using a differentially deformable anchoring structure and flexure geometry to prevent leakage and ensure accurate alignment and placement, allowing for various anatomical approaches.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional invasive open-heart surgery is used to treat atrioventricular valve insufficiency, then good clinical outcomes are achieved, but the procedure is highly invasive with lengthy recovery periods
Solution Approach 1:
The prosthetic heart valve is nested within a delivery catheter system, allowing the valve to be delivered through minimally invasive transcatheter access while maintaining the capability for secure implantation. The valve can be compressed within the catheter for delivery and then expanded at the target site, combining the benefits of minimally invasive delivery with reliable valve function.
Solution Approach 2:
A delivery catheter system acts as an intermediary between the operator and the prosthetic valve, enabling minimally invasive delivery while ensuring accurate placement. The delivery system provides controlled deployment and initial stabilization of the valve, bridging the gap between minimally invasive access and secure valve implantation.
2Ease of operation
If current transcatheter valve therapies are used for mitral valve insufficiency, then minimally invasive treatment is achieved, but limitations include outflow tract obstruction, thrombus formation, and unfavorable outcomes
Solution Approach 1:
The anchoring structure features differentially deformable regions with varying stiffness characteristics - a more compliant atrial region for conforming to the annulus and a stiffer ventricular region for providing stable anchoring. This local variation in mechanical properties allows the device to achieve secure anchoring while maintaining proper valve function and minimizing complications.
Solution Approach 2:
The flexure geometry incorporates dynamic elements that allow controlled movement and adaptation during the cardiac cycle. The flexure regions enable the anchoring structure to dynamically adjust to physiological movements while maintaining stable positioning, reducing the risk of thrombus formation and ensuring consistent valve function.
3Stability of the object's composition
If a prosthetic valve with rigid anchoring structure is used, then stable anchoring is achieved, but accurate alignment and placement become difficult
Solution Approach 1:
The anchoring structure transitions from a static rigid design to a dynamic system with flexure geometry that allows controlled deformation. The differentially deformable regions enable the structure to adapt its shape during deployment, facilitating accurate alignment with the native annulus while maintaining stable anchoring once positioned.
Solution Approach 2:
The anchoring structure utilizes changes in mechanical parameters (stiffness, deformability) across different regions to achieve both alignment accuracy and anchoring stability. The atrial region's higher compliance allows for precise positioning and conforming to the annulus, while the ventricular region's greater stiffness provides stable anchoring.
4Device complexity
If a one-size-fits-all transcatheter valve approach is used, then device simplicity is maintained, but adaptability to various anatomical configurations is limited
Solution Approach 1:
The anchoring structure incorporates regions with different mechanical properties - a more compliant atrial region and a stiffer ventricular region - allowing the single device design to adapt to various anatomical configurations while maintaining structural integrity and function.
Solution Approach 2:
The prosthetic valve device is designed with multi-functional capabilities to address various anatomical scenarios. The differentially deformable anchoring structure can adapt to different annular geometries and tissue characteristics, making the device universally applicable across diverse patient anatomies while maintaining consistent performance.
Data Source
AI summary
A system comprised of a prosthetic heart valve device (535, 555, 900, 1108, 1230, 1260, 1400, 1535), and a delivery system (1100, 1105, 1110, 1300, 1500). The prosthetic heart valve device (535, 555, 900, 1108, 1230, 1260, 1400, 1535) comprises a differentially deformable anchoring structure concentrically aligned with, radially adjacent to, and in direct connection with a valve frame (700). The atrial region (805, 1005, 1410, 1805, 1850) of the differentially deformable anchoring structure (800, 1229, 1259) comprises a plurality of alignment structures intended to aid in rotational orientation. This atrial region (805, 1005, 1410, 1805, 1850) is in direct connection with the valve frame through inflow region connection elements. The annular region of the differentially deformable anchoring structure comprises anchoring elements and an architecture having a radial stiffness suitable for deformation and conformation to the native anatomy; this region is void of connection to the valve frame. The ventricular region of the differentially deformable anchoring structure comprises a plurality of ventricular anchoring elements and a plurality of ventricular region connection elements, adjacent to and in contact with the outflow region of the connecting members of the valve frame. The delivery system is comprised of a proximal control assembly connected to a first bendable catheter comprising a primary inner lumen, one or more secondary lumens adjacent to the primary lumen, one or more tethers releasably connected to the atrial portion of the prosthetic heart valve device, and a second elongate catheter with connection elements that are releasably connected to the ventricular portion of the prosthetic heart valve device. A compensation mechanism is in connected communication with the second catheter and controllably enables conformational change of the prosthetic heart valve device during implantation.