Adjustable Valve Annulus Support Device for Transcatheter Therapy
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Solution Overview
Problem
Aortic valve dysfunction due to stenosis or regurgitation leads to reduced blood flow and potential complications like atrial fibrillation, blood clots, and heart failure, necessitating a method to support and promote proper valve closure without requiring invasive surgery or replacing the valve.
Innovation Solution
A device comprising multiple support members sutured to the valve annulus with adjustable connecting members and actuation mechanisms to ensure optimal alignment and closure of valve leaflets, allowing for real-time adjustments to accommodate individual anatomy and pathology.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional valve replacement surgery is performed, then valve function is restored, but patient undergoes invasive surgery with associated risks and recovery time
Solution Approach 1:
The patent introduces a transcatheter valve delivery system that acts as an intermediary between the catheter and the native valve. The self-expanding valve is delivered through a catheter and deployed within the native valve structure, providing a less invasive alternative to traditional open-heart surgery while restoring valve function.
Solution Approach 2:
The patent replaces the mechanical surgical intervention (open-heart surgery with direct valve replacement) with a less invasive mechanical system (transcatheter delivery system). The self-expanding valve structure provides the necessary mechanical function without requiring surgical incision and cardiopulmonary bypass.
2Ease of manufacture
If a fixed-size valve prosthesis is used, then manufacturing is simplified, but it cannot accommodate individual patient anatomy variations
Solution Approach 1:
The patent employs a self-expanding valve structure that changes its physical parameters (size, shape) after deployment. The valve is delivered in a compressed state through the catheter and then self-expands to its final configuration, allowing adaptation to the patient's native valve anatomy while maintaining a compact delivery profile.
Solution Approach 2:
The valve prosthesis transitions from a static compressed state during delivery to a dynamic self-expanded state after deployment. This dynamic transformation allows the valve to adapt to varying patient anatomies while maintaining a uniform delivery system, resolving the contradiction between manufacturing simplicity and anatomical adaptability.
3Stability of the object's composition
If the valve support device is made rigid for structural stability, then valve support is improved, but it cannot accommodate tissue movement and growth
Solution Approach 1:
The patent utilizes a self-expanding valve structure that inherently possesses flexibility to accommodate tissue movement and growth while maintaining structural stability. The valve framework is designed to be compliant with surrounding tissues, allowing for physiological motion without compromising support function.
Data Source
AI summary
A device (100) for supporting a valve annulus is described that includes spaced apart support members (105) and a connecting member (110) extending between and connecting the support members. At least one adjustor (115) is also provided that is engaged with the connecting member and can be actuated to modify a length of the connecting member between two adjacent support members. In addition, each support member may include at least two channels extending through the support members at different heights with respect to an overall thickness of the respective support member. Each channel may receive a portion of the connecting member therethrough, and each support member may further include a passageway between the channels to allow selection of one of the channels. In this way, the device may be adjusted in at least two dimensions to support the valve leaflets and promote sufficient closure of the leaflets.