Transapical Valve Clip Removal Device
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Solution Overview
Problem
Current methods for removing valve clips from the mitral valve, especially those with larger device profiles, are invasive and pose risks such as bleeding and healing issues due to the need for larger catheters, and there is a need for minimally invasive systems to facilitate the removal of these clips.
Innovation Solution
A transapical removal device comprising a delivery catheter with a grasping tool that can manipulate the valve clip from an implanted condition to an elongated condition, allowing for removal through a smaller diameter, and a removal tool that can surround and extract the clip, potentially using ablation to assist in tissue removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical removal of valve clip is performed, then complete removal can be achieved, but morbidity and mortality are elevated
Solution Approach 1:
The patent replaces the mechanical surgical removal system with a catheter-based delivery system that uses controlled mechanical expansion and tissue interaction to achieve clip removal, thereby reducing the harmful effects associated with open surgery while maintaining removal effectiveness
Solution Approach 2:
The patent introduces a delivery catheter and deployment tool as intermediary devices between the operator and the valve clip, enabling minimally invasive access to the heart valve through transapical or transvenous routes, thus reducing morbidity and mortality compared to direct surgical approaches
2Ease of operation
If larger diameter catheter is used for minimally invasive removal, then minimally invasive access is achieved, but risk of bleeding and healing issues increases
Solution Approach 1:
The patent employs a delivery catheter with a collapsible or expandable distal end that can transition between compressed and expanded states, allowing the device to pass through small access sites in a compressed state and then expand at the target location to perform the removal function, thereby minimizing access site size and associated bleeding risks
Solution Approach 2:
The patent divides the removal device into multiple functional components including a delivery catheter, grasping tool, and removal tool that can be deployed sequentially through a small access site, allowing each component to perform its specific function while maintaining minimal catheter diameter for safe patient access
3Strength
If valve clip with larger device profile is used, then initial clipping function is improved, but removal difficulty increases
Solution Approach 1:
The patent incorporates a grasping tool that is deployed first to engage and secure the valve clip before the actual removal process begins, allowing the operator to control and manipulate the clip's position and orientation, thereby simplifying the subsequent removal of larger-profile clips through staged manipulation
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 minimally invasive removal of valve clips with reduced risk of bleeding and healing issues by allowing the clip to be elongated and removed through a smaller catheter, improving the efficiency and safety of the procedure.
Implementation Method 1
removal tool which is extendable relative to the distal end portion of the delivery catheter, and which is configured to at least partially surround the valve clip in the elongated condition and to remove the valve clip from the heart valve leaflet
Data Source
AI summary
Devices and methods for removing a valve clip which is pre-positioned on a heart leaflet, the valve clip including a delivery catheter having a distal end portion configured to be positioned near a heart valve; a grasping tool deployable from the distal end portion of the delivery catheter, the grasping tool configured to grasp and manipulate a valve clip from an implanted condition to an elongated condition, wherein the valve clip in the elongated condition has an elongated width less than an implanted width of the valve clip in the implanted condition; and a removal tool extendable relative to the distal end portion of the delivery catheter, the removal tool configured to at least partially surround the valve clip in the elongated condition and to remove the valve clip from the heart valve leaflet.