Tissue Cutting Elements for Mitral Valve Obstruction Prevention
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Solution Overview
Problem
Transcatheter techniques for prosthetic valve deployment face challenges in accessing and positioning the valve correctly within the anatomy, and the interaction between the prosthetic valve and surrounding tissue can impact performance, leading to potential health issues for patients.
Innovation Solution
A prosthetic valve design incorporating a support structure with a tissue cutting element that can be transitioned from an inactive to an active state, allowing for precise cutting and positioning of native leaflet tissue, such as the anterior leaflet of a mitral valve, to avoid left ventricular output tract obstruction, using a tissue cutting element that can be configured as electrosurgical or bioresorbable, with cutting edges that are sharp or dull for immediate or gradual tissue cutting.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If transcatheter techniques are used for prosthetic valve deployment, then patient trauma is minimized, but proper positioning and access to treatment regions become more difficult
Solution Approach 1:
The tissue cutting element is deployed before the prosthetic valve to pre-shape the annulus and create optimal positioning conditions. This preliminary action facilitates subsequent valve deployment and positioning by removing tissue obstacles and creating favorable anatomical conditions in advance.
Solution Approach 2:
The tissue cutting element acts as an intermediary tool that modifies the tissue environment between the delivery system and the final valve position. By cutting and reshaping tissue, it mediates the interaction between the prosthetic valve and native anatomy, enabling proper valve placement without requiring more invasive surgical access.
2Reliability
If the tissue cutting element is kept inactive during delivery, then device safety is improved, but the ability to cut tissue during deployment is delayed
Solution Approach 1:
The tissue cutting element transitions from an inactive, retracted state during delivery to an active, extended state during deployment. This dynamic configuration allows the element to remain safe and contained during transit while becoming functional when needed, optimizing both safety and operational effectiveness through state changes.
Solution Approach 2:
The tissue cutting element is nested within or retracted against the prosthetic valve frame during delivery, containing it in a safe, inactive position. Upon deployment, the element extends outward from its nested position to perform tissue cutting, allowing compact delivery while maintaining cutting capability.
3Productivity
If sharp cutting edges are used, then cutting speed is improved, but the risk of uncontrolled tissue damage increases
Solution Approach 1:
The cutting element's parameters (sharpness, geometry, material properties) are optimized to achieve effective tissue cutting while controlling damage. The element may feature specialized geometries or materials that allow cutting at lower forces, reducing the risk of uncontrolled tissue damage while maintaining adequate cutting speed for the application.
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 precise cutting and positioning of native leaflet tissue, improving the deployment and performance of prosthetic valves by minimizing obstruction and enhancing patient health outcomes.
Implementation Method 1
the tissue cutting element is configured as an electrosurgical cutting element
Data Source
AI summary
Prosthetic valves and associated methods and systems are disclosed, including a prosthetic valve with a support structure and a leaflet construct coupled to the support structure, and a tissue cutting element coupled to a portion of the prosthetic valve.