Tensioned Prosthetic Valve Implant for Precise Percutaneous Positioning
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Solution Overview
Problem
Existing heart valve replacement procedures, such as those for tricuspid regurgitation, are invasive and risky, requiring complex open-heart surgeries with significant recovery challenges, and there is a need for a simpler and easier solution.
Innovation Solution
A prosthetic implant with an anchor member, resilient tethering struts, and a tensioning unit comprising a flexible hollow tubing and tensioning wire, along with a delivery apparatus that allows for precise control and deployment of the implant using a control handle and tensioning rod to adjust the position and orientation of the coaptation structure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open-heart procedures are used for valve replacement, then reliable valve replacement is achieved, but surgical risk and recovery difficulty increase significantly
Solution Approach 1:
The patent replaces the mechanical open-heart surgical system with a percutaneous delivery system that uses catheter-based delivery and balloon expansion to implant the valve prosthesis through a blood vessel, eliminating the need for sternotomy and cardiopulmonary bypass
Solution Approach 2:
The patent introduces a delivery catheter and balloon as intermediary tools to deliver and deploy the valve prosthesis through the bloodstream to the target location, avoiding direct surgical access to the heart
2Object-affected harmful factors
If percutaneous transluminal valve replacement is used, then surgical risk is reduced, but control precision over implant positioning and orientation becomes challenging
Solution Approach 1:
The patent employs a delivery system with adjustable and repositionable components, including the ability to adjust the orientation of the valve prosthesis during deployment and to retract or reposition the implant before final deployment, providing dynamic control over positioning and orientation
Solution Approach 2:
The patent allows for preliminary positioning and orientation adjustments of the valve prosthesis before final deployment, enabling the operator to optimize the implant position and orientation prior to committing to the final placement
3Manufacturing precision
If complex delivery systems are used to achieve precise control, then positioning accuracy improves, but device complexity increases
Solution Approach 1:
The patent integrates multiple functions into a unified delivery system, where the delivery catheter serves both as the delivery conduit and the deployment mechanism, and the balloon serves both as an expansion tool and a positioning reference, reducing the number of separate components
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
Enables a less invasive and more efficient heart valve replacement procedure by providing fine control and adjustment of the prosthetic implant's position and orientation, reducing surgical risks and improving recovery.
Implementation Method 1
at least one resilient tethering strut extending from the anchor member
Data Source
AI summary
A prosthetic implant including an anchor member; at least one resilient tethering strut extending from the anchor member; a coaptation structure coupled to an end of the at least one resilient tethering strut; and a tensioning unit extending between the anchor member and the coaptation structure. The tensioning unit including a flexible hollow tubing, and a tensioning wire extending therethrough with a first end of the tensioning wire fixed at a junction between a first end of the flexible hollow tubing and the coaptation structure and with a second end of the tensioning wire extending out from a second end of the flexible hollow tubing. The second end of the tensioning wire being pullable away from the second end of the flexible hollow tubing to bend the flexible hollow tubing and the at least one resilient tethering strut to move the coaptation structure relative to the anchor member.