Balloon Electrocautery Leaflet Excision for Coronary Ostia Access
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Solution Overview
Problem
Existing medical devices face challenges in effectively excising cardiac valve leaflets to prevent them from blocking coronary ostia during artificial heart valve implantation, which can complicate procedures like balloon angioplasty or stent placement.
Innovation Solution
A medical device with an elongate shaft and inflatable balloon, equipped with an electrocautery electrode, is used to excise valve leaflets by applying RF energy, with optional features like vacuum capture and adhesive layers to facilitate removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing medical devices are used to excise cardiac valve leaflets, then the procedure can be performed, but the devices fail to effectively prevent ostial blockage and complicate subsequent procedures
Solution Approach 1:
The patent extracts and removes the problematic valve leaflet tissue from the coronary ostia region using a specialized excision device. The device includes a cutting element that selectively removes leaflet material that could cause blockage, while preserving the functional valve structure. This extraction principle directly addresses the harmful effect of ostial blockage by removing the causative tissue.
Solution Approach 2:
The patent introduces an intermediary device that facilitates safe leaflet excision. The device includes a protective shielding structure and a controlled cutting mechanism that acts as an intermediary between the surgeon's intent and the tissue manipulation. This intermediary structure enables precise removal of problematic leaflet tissue while protecting surrounding structures and minimizing harm.
2Ease of operation
If valve leaflets are not excised, then the procedure is simpler, but coronary ostia become blocked during artificial heart valve implantation
Solution Approach 1:
The patent performs preliminary excision of valve leaflets before artificial heart valve implantation. By removing problematic leaflet tissue in advance, the procedure prevents future ostial blockage complications. This preliminary action simplifies the subsequent implantation procedure by eliminating the need for complex maneuvers to avoid blocked ostia, thereby resolving the contradiction between procedural simplicity and preventing harm.
3Productivity
If traditional excision methods are used, then the procedure can be completed, but subsequent balloon angioplasty or stent placement becomes complicated
Solution Approach 1:
The patent thoroughly extracts problematic leaflet tissue from the coronary ostia region using a specialized excision device. By completely removing the obstructive tissue rather than partially trimming it, the procedure eliminates the source of future complications. This thorough extraction simplifies subsequent balloon angioplasty or stent placement by ensuring clear access to the coronary ostia, thereby reducing device complexity requirements for follow-up procedures.
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 device efficiently excises valve leaflets, preventing ostial blockage and enabling smoother implantation of artificial heart valves and subsequent procedures.
Implementation Method 1
when RF energy is applied to the electrocautery electrode and the inflatable balloon is in the inflated configuration
Implementation Method 2
A source of vacuum may be fluidly coupled with the space defined between the inner balloon wall and the outer balloon wall
Data Source
AI summary
A medical device that is adapted for excising a valve leaflet portion of a valve leaflet from a heart valve includes an elongate shaft including a distal region and an inflatable balloon that is secured to the distal region and that is adapted to extend through the heart valve. The inflatable balloon has an outer surface and includes a deflated configuration and an inflated configuration. An electrocautery electrode is disposed relative to the inflatable balloon such that the electrocautery electrode is positioned to excise the valve leaflet portion when RF energy is applied to the electrocautery electrode and the inflatable balloon is in the inflated configuration. In some cases, the heart valve includes an artificial heart valve. In some cases, the valve leaflet includes an artificial valve leaflet.