Heart Valve Tissue Cutter with Guided Blade for Precise Slicing
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Solution Overview
Problem
Existing transcatheter procedures for modifying heart valve leaflets, such as those used in BASILICA and LAMPOON, often cause damage to neighboring tissues and are inefficient in cutting or splitting heart valve tissues without causing collateral harm.
Innovation Solution
A heart valve tissue cutting device with a housing, cutting guide arm, and a cutting element comprising a cutting blade and stabbing element, where the stabbing element is tilted relative to the cutting blade, allowing precise tissue acquisition and slicing, and a four-hinge mechanism for deployment, ensuring controlled tissue modification.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If existing transcatheter procedures use cutting devices to modify heart valve leaflets, then tissue modification is achieved, but damage to neighboring tissues occurs
Solution Approach 1:
The cutting device is divided into separate functional components: a stabbing element for initial tissue penetration and a cutting blade for subsequent slicing. This segmentation allows each element to perform its specific function optimally while reducing unintended tissue damage. The stabbing element creates a controlled entry point, and the cutting blade follows a predetermined path through the guide arm, ensuring precise tissue modification without affecting neighboring structures.
Solution Approach 2:
A guide arm with a guide slot serves as an intermediary structure that directs the cutting blade along a predetermined safe path. This guide arm acts as a mediator between the cutting blade and the tissue, ensuring that the blade follows only the intended cutting trajectory and prevents deviation that could cause damage to neighboring tissues. The guide slot physically constrains the blade movement to the desired path.
2Productivity
If a cutting device is designed with both stabbing and cutting functions, then cutting efficiency is improved, but device complexity increases
Solution Approach 1:
The stabbing element and cutting blade are merged into a single integrated cutting element assembly that performs both functions sequentially. The stabbing element is positioned at the distal end to create initial penetration, while the cutting blade is attached to extend from the stabbing element. This merging of functions into one assembly improves cutting efficiency by eliminating the need for separate devices or steps, while the overall complexity is managed through the unified design.
Solution Approach 2:
The cutting element is designed with dynamic deployment characteristics. The stabbing element and cutting blade can be deployed and retracted along the delivery catheter, allowing the device to transition from a compact delivery state to an active cutting state. This dynamic capability enables the complex multi-function device to be delivered through standard catheter routes while providing both stabbing and cutting functions when deployed.
Data Source
AI summary
A heart valve tissue cutting device includes a housing formed with an elongate opening, a cutting guide arm pivoted to the housing by a hinge assembly, and a cutting element including a cutting blade and a stabbing element. The cutting guide arm is formed with a guide slot. The cutting element is arranged to move on a track structure in the housing. A sharp pointed end of the stabbing element is tilted with respect to the cutting blade and points towards the cutting guide arm. The cutting blade is arranged, when in a deployed position, to pass through the guide slot.