Valve Prosthesis with Flexible Fixation and Closure Assistance
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Solution Overview
Problem
Current transcatheter treatments for valve regurgitation face challenges in accurately positioning and securely anchoring devices, particularly for partial valve prolapse, due to the complex physiological structures of the mitral and tricuspid annuli, and the need to minimize impact on normal valve leaflet function.
Innovation Solution
A prosthesis with a flexible fixation unit, connection piece, and closure assisting piece, featuring a frame structure made of shape memory material, which allows for adjustable positioning and anchoring, and includes a channel for blood flow to prevent adhesion, ensuring the prosthesis is securely anchored without interfering with normal valve leaflet movement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a transcatheter prosthesis is used to prevent valve regurgitation, then the invasiveness of surgery is reduced and complication risk is lowered, but the device positioning accuracy and anchoring security become challenging due to complex annular structures
Solution Approach 1:
The prosthesis employs a dynamic delivery system that allows the device to transition from a compressed delivery state to an expanded functional state. The delivery catheter enables the prosthesis to be navigated through vasculature to the target annulus, then expanded at the precise location using balloon inflation or self-expansion mechanisms, ensuring accurate positioning while maintaining low invasiveness throughout the procedure.
Solution Approach 2:
The patent introduces intermediate anchoring structures such as annular bars or fixation elements that mediate between the prosthesis and the complex annular tissue. These intermediaries provide secure attachment points on irregular annular surfaces, ensuring stable positioning without requiring highly precise initial device placement, thus resolving the contradiction between minimally invasive delivery and accurate positioning.
2Ease of manufacture
If the prosthesis is designed with a fixed structure, then manufacturing is simplified, but the device cannot adapt to different annulus sizes and prolapse locations
Solution Approach 1:
The prosthesis incorporates adjustable geometric parameters including variable annular bar diameters, configurable leaflet coverage areas, and modifiable connection piece lengths. These parameter variations allow the same basic prosthesis design to adapt to different annulus sizes and prolapse locations while maintaining a streamlined manufacturing process through modular component production and selective assembly.
Solution Approach 2:
The prosthesis is divided into segmented modular components including separate annular bars, connection pieces, and closure assisting pieces that can be independently manufactured and then assembled. This segmentation enables customization for different patient anatomies while keeping individual component manufacturing simple and scalable, resolving the contradiction between manufacturing ease and adaptability.
3Reliability
If the prosthesis fully covers the valve annulus, then regurgitation prevention is maximized, but normal valve leaflet movement is interfered with
Solution Approach 1:
The prosthesis implements local quality by providing targeted closure assistance only at specific segments of the valve annulus where regurgitation occurs, rather than uniformly covering the entire annulus. The closure assisting pieces are positioned locally at prolapse sites, and the connection pieces are configured to support leaflet coaptation only in affected regions, thereby preventing regurgitation while preserving normal movement in healthy valve segments.
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 prosthesis effectively prevents valve regurgitation with reduced implant volume, improved blood dynamics, and lower complication rates, while adapting to different annulus sizes and prolapse locations, maintaining normal valve function and reducing the risk of adhesion and regurgitation.
Implementation Method 1
the frame structure is made of shape memory material
Data Source
Figure 1A~1B
Figure 2A~2D
Figure 3A~3D
AI summary
A prosthesis (100) for preventing a valve regurgitation, comprising a fixation unit (110), a connection piece (120) and a closure assisting piece (130); the fixation unit (110) comprises a fixation piece (111) and an anchor (112); the connection piece (120) is flexible, and a distal section thereof is connected to a proximal section of the fixation piece (111), and a proximal section thereof is connected to a distal section of the closure assisting piece (130); the fixation piece (111) is fixed on the atrial wall or a valve ring of a patient via the anchor (112); the deployed width of the fixation piece (111) is less than two-thirds of the circumference of a valve tissue annulus; the closure assisting piece (130) is located between autologous valve leaflets of the patient when in a free state; the maximum width of the closure assisting piece (130) is less than the maximum deployed width of a single autologous valve leaflet; and the proximal end of the anchor (112) is provided with an anti-disengagement end (1120). The position of the prosthesis (100) can be adjusted, and the prosthesis (100) is accurately positioned and firmly anchored, and does not readily adhere to tissue adjacent to the valve annulus of the patient.