Independent Valve Leaflet Electrodes for Controlled Laceration
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing medical devices for lacerating cardiac valve leaflets face challenges in efficiently and selectively cutting native or artificial valve leaflets to prevent obstruction of coronary arteries during artificial heart valve implantation, particularly when existing leaflets are displaced by the expandable frame of the artificial valve.
Innovation Solution
A medical device with an elongate shaft featuring a deflectable distal region and independently energized piercing and lacerating electrodes, allowing precise and controlled laceration of valve leaflets, either native or artificial, by selectively energizing one electrode at a time and using a deflection actuation mechanism to adjust the electrode position.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single electrode is used for both piercing and lacerating, then the device structure is simplified, but the ability to selectively lacerate valve leaflets without piercing is lost
Solution Approach 1:
The single electrode is divided into two separate electrodes: a piercing electrode and a lacerating electrode. This segmentation allows each electrode to be independently controlled and energized, enabling selective laceration of valve leaflets without piercing, while maintaining a relatively simple overall device structure.
2Stability of the object's composition
If the distal region is made rigid for stable electrode positioning, then electrode positioning stability is improved, but the ability to deflect and reposition electrodes is lost
Solution Approach 1:
The distal region is designed with flexible or deflectable portions that allow the electrodes to be repositioned by applying force through the elongate shaft. This dynamic design enables the distal region to deflect and reposition electrodes while maintaining sufficient stability during electrode engagement with valve leaflets.
3Productivity
If both electrodes are always energized, then the laceration process is continuous, but the risk of unintended tissue damage increases
Solution Approach 1:
The control system enables selective energization of either the piercing electrode or the lacerating electrode based on the procedural requirements. This feedback-based control allows the operator to activate only the necessary electrode at any given time, preventing unintended tissue damage while maintaining efficient laceration capability when needed.
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 effective laceration of valve leaflets to prevent coronary artery ostium obstruction, facilitating smoother implantation of artificial heart valves and reducing complications in subsequent procedures like angioplasty or stent placement.
Implementation Method 1
A piercing electrode is disposed relative to the distal end and is adapted to pierce through a valve leaflet
Implementation Method 2
A lacerating electrode is spaced and electrically insulated from the piercing electrode and is adapted to lacerate the valve leaflet subsequent to the piercing electrode piercing the valve leaflet
Data Source
AI summary
A medical device for cutting valve leaflets includes an elongate shaft that extends proximally from a deflectable distal region, where the deflectable distal region includes a distal end and the deflectable distal region includes a biased configuration. A piercing is electrode disposed relative to the distal end and is adapted to pierce through a valve leaflet. A lacerating electrode is spaced from the piercing electrode and is adapted to lacerate the valve leaflet subsequent to the piercing electrode piercing the valve leaflet. The piercing electrode and the lacerating electrode are independently energized.