Mitral Valve Cinching Apparatus with Adjustable Tensioning
Solution Overview
Problem
Current methods for treating mitral valve regurgitation, such as small ring annuloplasty and conventional septal-lateral annular cinching, often alter the normal function of the mitral valve, leading to loss of annular flexibility and transvalvular gradients, and lack minimally invasive solutions capable of incremental adjustments on a beating heart.
Innovation Solution
A minimally invasive apparatus and method that involves attaching anchoring and locking components to tissue components of the heart valve, with a tension member adjusting the distance between these components, allowing incremental reduction of the septal-lateral diameter of the mitral valve, enabling the method to be implemented on a beating heart and repeated as needed.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional annular cinching methods are used to reduce mitral valve diameter, then valve regurgitation is treated, but the normal function of the mitral valve is altered, leading to loss of annular flexibility and transvalvular gradients
Solution Approach 1:
The invention employs a dynamic, adjustable tensioning system that allows the mitral valve annulus to maintain flexibility while providing controlled reduction. The apparatus includes adjustable tensioning elements that can be modified post-implantation, enabling the annulus to adapt dynamically to physiological conditions while treating regurgitation, thus preserving normal valve function.
Solution Approach 2:
The invention changes the parameter of annular dimension in a controlled and reversible manner. By using adjustable tensioning mechanisms, the system allows for incremental modification of the annular diameter without permanently altering the structural properties of the valve, thereby maintaining annular flexibility while improving valve competence.
2Manufacturing precision
If rigid annuloplasty rings are used to correct mitral valve regurgitation, then valve dimension is controlled, but transvalvular gradients are created and normal valve dynamics are disrupted
Solution Approach 1:
The invention replaces rigid annuloplasty rings with flexible tensioning elements that can conform to the natural geometry of the mitral annulus. These flexible elements provide dimensional control while allowing the annulus to maintain its natural dynamics, thereby preventing the creation of transvalvular gradients and preserving normal valve function.
Solution Approach 2:
The adjustable and flexible nature of the tensioning system allows it to adapt to the dynamic motion of the mitral valve during the cardiac cycle, preventing the formation of fixed gradients that would occur with rigid structures.
3Reliability
If traditional surgical methods are used for mitral valve repair, then valve competence is improved, but the procedures are invasive and cannot be easily repeated for incremental adjustments
Solution Approach 1:
The invention divides the valve repair function into separate, independently adjustable components. The tensioning elements can be adjusted incrementally and individually, allowing for staged repair procedures that can be performed through minimally invasive access, reducing surgical trauma and enabling repeat procedures if needed.
Solution Approach 2:
The apparatus is designed to be universally applicable through minimally invasive delivery methods while providing the capability for incremental adjustments. The same device can be used for both initial repair and subsequent refinements, eliminating the need for different surgical approaches for different stages of treatment.
4Length of stationary object
If fixed-dimensional annuloplasty is performed, then valve dimension is reduced, but the ability to make incremental adjustments is lost
Solution Approach 1:
The invention transforms the fixed-dimensional annuloplasty into a dynamic system with adjustable tensioning elements. These elements can be modified incrementally after implantation, allowing the mitral valve diameter to be adjusted in stages to achieve optimal valve competence while minimizing trauma to the valve structure.
Solution Approach 2:
The adjustable design allows for feedback-based optimization of valve dimension. The tensioning elements can be modified based on post-implantation assessment of valve function, enabling incremental adjustments until optimal competence is achieved without overtreatment.
Data Source
AI summary
The cinching apparatus (800) comprising: an anchoring component having a distal end a proximal end; the distal end of the anchoring component having an engaging member (805). A locking component (815) and a tension member (820) wherein the anchoring component is enabled to be positioned on a first target site of a tissue component and the locking component (815) is enabled to be positioned on a second target site of a tissue component of the heart, and the tension member (820) can be coupled to both the anchoring component and the locking component (815) to adjust the distance between the first and second target sites.