Heart Valve Leaflet Laceration Guided by Coronary Wire Alignment
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Solution Overview
Problem
Existing medical procedures for accessing and modifying heart valve leaflets to ensure unobstructed coronary ostia are challenging due to irregular patient anatomy, making precise alignment of initial puncture points difficult and potentially life-threatening.
Innovation Solution
A system comprising a coronary guidewire and a laceration device with an ablative cutting element, which can be aligned with the nadir of the heart valve leaflet, optionally with an expandable structure for anchoring and a bifurcated catheter design to facilitate precise laceration of the leaflet, ensuring accurate access to the coronary ostia.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a basilica procedure is performed to modify heart valve leaflets for accessing coronary ostia, then access to coronary ostia is improved, but the risk of obstructing coronary ostia increases due to difficulty in precisely locating the initial penetration point
Solution Approach 1:
The patent introduces a guidewire as an intermediary device that is first positioned in the coronary artery to establish a safe reference path. The laceration device then uses this guidewire as a mediator to align its cutting element precisely, ensuring the leaflet is cut at the correct location without obstructing the coronary ostia. This intermediary approach eliminates the need to directly locate the penetration point without reference.
Solution Approach 2:
The patent performs preliminary action by first advancing the guidewire into the coronary artery and positioning it correctly before performing the leaflet laceration. This preliminary positioning establishes a safe reference that guides subsequent cutting actions, ensuring that the coronary ostia are not obstructed during the basilica procedure.
2Manufacturing precision
If the laceration device is aligned with the nadir of the heart valve leaflet using a guidewire, then manufacturing precision of the cut location is improved, but device complexity increases due to multiple components
Solution Approach 1:
The patent applies nesting by placing the laceration device within a catheter, which in turn is advanced over the guidewire. This nested configuration allows multiple functional components (guidewire for positioning, catheter for containment and delivery, laceration device for cutting) to be integrated in a space-efficient manner while maintaining precise alignment capabilities through the guidewire-catheter-laceration device hierarchy.
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 system enables precise and safe laceration of heart valve leaflets, improving access to coronary ostia and reducing the risk of obstruction, thereby enhancing the safety and efficacy of heart valve replacement procedures.
Implementation Method 1
a laceration device with an ablative cutting element, which can be aligned with the nadir of the heart valve leaflet
Implementation Method 2
the distal end of the coronary guidewire comprises an expandable structure configured to anchor the coronary guidewire within the coronary artery in an expanded configuration
Data Source
AI summary
A system for lacerating heart valve leaflets includes a coronary guidewire and a laceration device including an ablative cutting element. A system may include a first guidewire for insertion into a left ventricle and a guide catheter configured to translate along the first guidewire. The guide catheter may include a steering element configured to direct the coronary guidewire toward the coronary artery. The laceration device cooperates with the coronary guidewire to align the ablative cutting element with a nadir of a heart valve leaflet. A method of lacerating heart valve leaflets includes advancing the coronary guidewire into a coronary artery, translating the laceration device along the coronary guidewire to a position adjacent a heart valve leaflet, positioning the ablative cutting element in contact with a nadir of the heart valve leaflet, and lacerating the heart valve leaflet from the nadir to a free edge of the heart valve leaflet.