Steerable Leaflet Grasper for Transcatheter Valve Cutting
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Solution Overview
Problem
Current minimally invasive heart valve replacement techniques, such as TAVR and TMVR, can cause complications like coronary artery obstruction and LVOT obstruction, requiring complex and expertise-dependent procedures like BASILICA and LAMPOON to address these issues, which are not accessible to all patients due to technical complexity and the need for specialized skills.
Innovation Solution
Development of steerable leaflet grasper and catheter systems that allow for minimally invasive cutting and resection of heart valve leaflets, enabling the devices to grab, lacerate, and resect leaflet tissue, facilitating the implantation of transcatheter valves by restoring normal valve function and preventing obstructions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If existing guiding catheters and wires are used to lacerate native leaflets using radiofrequency energy (BASILICA technique), then coronary artery obstruction is prevented, but the procedure requires a high level of expertise and specialized skills
Solution Approach 1:
The device divides the leaflet modification function into separate components: a grasping mechanism for positioning and a cutting mechanism for laceration. This segmentation allows each component to be optimized independently, making the overall procedure more manageable and less expertise-dependent while still achieving the goal of preventing coronary obstruction
Solution Approach 2:
The patent introduces an intermediary cutting element that can be delivered through a catheter system, serving as a mediator between the operator and the leaflet tissue. This intermediary tool simplifies the procedure by providing a standardized, easier-to-use cutting mechanism rather than requiring direct manipulation with complex guiding catheters and wires
2Object-affected harmful factors
If catheters and wires are used to lacerate the anterior mitral leaflet (LAMPOON technique), then LVOT obstruction is prevented, but the procedure is technically complicated and requires specialized expertise
Solution Approach 1:
The device incorporates a steerable, deflectable catheter shaft that can dynamically adjust its position and orientation. This dynamic capability allows the catheter to adapt to different anatomical configurations and access the anterior mitral leaflet more easily, reducing the technical complexity and increasing procedure accessibility
Solution Approach 2:
The catheter system is designed with multi-functionality, combining grasping, cutting, and positioning capabilities in a single device. This universal design eliminates the need for multiple specialized tools and procedures, making the LAMPOON technique more accessible and easier to perform while still preventing LVOT obstruction
3Object-affected harmful factors
If standard BASILICA technique is used for TAVR procedures, then coronary obstruction is addressed, but it is insufficient for patients requiring more extensive cutting or resection
Solution Approach 1:
The device allows for segmented, controlled cutting of the leaflet through the use of a grasper that can position itself at different locations along the leaflet length. This enables extensive cutting or resection when needed, while still maintaining the ability to address coronary obstruction with minimal intervention
Solution Approach 2:
The device enables parameter changes in terms of cutting depth, location, and extent by allowing the operator to adjust the grasper position and cutting element engagement. This flexibility adapts the procedure to individual patient needs, whether minimal laceration or extensive resection is required
4Reliability
If TEER devices are implanted to reduce valvular regurgitation, then valve function is improved, but regurgitation may recur or insufficient reduction is achieved, requiring surgical excision
Solution Approach 1:
The device enables preliminary cutting or resection of the leaflet before TEER implantation, creating a more favorable anatomical configuration. This preliminary action can prevent regurgitation recurrence or insufficient reduction, thereby improving the durability of the valve repair and reducing the need for complex surgical excision in revision cases
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 steerable leaflet grasper and catheter systems provide a more accessible, reproducible, and robust method for modifying heart valve leaflets, reducing the complexity of procedures like BASILICA and LAMPOON, allowing for safer and more effective transcatheter valve implantations by preventing obstructions and improving valve function.
Implementation Method 1
catheters and wires are used to lacerate one or more native aortic leaflets using radiofrequency energy
Data Source
AI summary
A minimally invasive and steerable leaflet grasper for intracardiac implantation into a heart chamber for grasping a heart leaflet and modifying the leaflet. The leaflet grasper includes a proximal control knob for controlling the distal grasping end of the leaflet grasper having a grasping arm, gripper, and laceration element for securing the leaflet and modifying the leaflet. The method includes using a single leaflet grasper to secure and lacerate the leaflet.