Anterior Mitral Leaflet Laceration Device for SAM Prevention
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Solution Overview
Problem
Current procedures for mitral valve replacement, such as LAMPOON and BASILICA, are complex, invasive, and often unsuccessful in preventing systolic anterior motion (SAM) and left ventricular outflow tract (LVOT) obstruction due to the need for precise and unpredictable leaflet laceration, which can be time-consuming and risky, especially for inexperienced operators.
Innovation Solution
A leaflet laceration device with an elongated shaft, a moveable arm, and a cutting element, allowing for precise and flexible laceration of anterior mitral leaflets via various approaches (transapical, transeptal, or transaortic) to minimize SAM and LVOT obstruction, enabling safer and more efficient valve implantation procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional LAMPOON or BASILICA procedures are used for anterior mitral leaflet laceration, then the procedure can be performed to prevent SAM and LVOT obstruction, but the procedure becomes complex, time-consuming, and requires high operator skill
Solution Approach 1:
The procedure is segmented into distinct functional components: the elongated shaft for access, the moveable arm for positioning, and the cutting element for laceration. This segmentation allows each component to be optimized independently and simplifies the overall procedural steps.
Solution Approach 2:
The device allows preliminary positioning and confirmation of the cutting element at the desired laceration site before actual cutting occurs. The moveable arm can be adjusted to position the cutting element precisely, and the procedure can be paused to verify correct placement before committing to the laceration.
2Reliability
If traditional LAMPOON or BASILICA procedures are used for anterior mitral leaflet laceration, then the procedure can be performed to prevent SAM and LVOT obstruction, but the procedural time increases and operator inexperience becomes a risk factor
Solution Approach 1:
The moveable arm provides dynamic adjustability during the procedure, allowing real-time positioning corrections without requiring complete procedural restart. This dynamic capability reduces procedural time by enabling quick adjustments rather than requiring fixed, pre-planned positions that may need correction.
Solution Approach 2:
The device design enables self-alignment and self-positioning features that reduce dependence on operator skill for critical positioning steps. The elongated shaft and moveable arm configuration allows the device to guide itself to the target location with minimal manual manipulation.
3Reliability
If precise and unpredictable leaflet laceration is performed using traditional methods, then SAM and LVOT obstruction can be addressed, but the procedure becomes risky especially for inexperienced operators
Solution Approach 1:
The moveable arm acts as an intermediary between the operator and the cutting element, providing a controlled interface that mediates the precision required for safe laceration. This intermediary mechanism translates gross operator movements into fine positional adjustments, reducing the skill gap and procedural risk.
Solution Approach 2:
The device replaces complex manual manipulation techniques with a standardized mechanical system consisting of the elongated shaft and moveable arm mechanism. This mechanical substitution provides consistent, repeatable positioning that is less dependent on operator experience and reduces procedural variability and risk.
Data Source
AI summary
In some embodiments, a leaflet laceration device, includes an elongated shaft, a moveable arm coupled to the elongated shaft and pivotable relative thereto between an open condition and a closed condition, and a cutting element coupled to at least one of the elongated shaft and the moveable arm, the cutting element being configured and arranged to contact a first surface of an anterior mitral leaflet.