Heart valve treatment members with changeable orientation
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Solution Overview
Problem
Existing transcatheter aortic valve replacement (TAVR) procedures face challenges due to calcifications on bicuspid aortic valve (BAV) leaflets and raphes, which impair valve functionality and complicate the implantation process.
Innovation Solution
A device with two heart valve treatment members, one with a scoring portion and the other with a counterforce member, is used to fracture calcifications by applying forces in various orientations to increase leaflet pliability, either as standalone treatment or to prepare the 'landing zone' for valve implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a fixed orientation scoring device is used to fracture calcifications, then the device structure is simple, but it cannot adapt to different calcification patterns and valve anatomies
Solution Approach 1:
The scoring portion is made movable relative to the shaft, allowing it to change orientation from parallel to perpendicular to the commissure. This dynamic adjustment capability enables the device to adapt to different calcification patterns without requiring multiple fixed-orientation devices, thus improving versatility while maintaining reasonable structural complexity.
Solution Approach 2:
The device is divided into distinct functional components: the shaft, the scoring portion, and the counterforce member. The scoring portion can be independently positioned and oriented, allowing it to be segmented from the main shaft structure. This segmentation enables flexible orientation changes while keeping the overall device structure manageable.
2Adaptability or versatility
If multiple fixed-orientation devices are used to cover all calcification patterns, then all calcification patterns can be treated, but the device complexity and procedure time increase
Solution Approach 1:
A single device with a movable scoring portion is designed to perform multiple functions by adjusting the orientation of the scoring portion to different angles. This universal device can treat all calcification patterns (parallel, perpendicular, and intermediate orientations) that would otherwise require multiple specialized devices, thereby reducing procedure time and simplifying the overall treatment process.
3Reliability
If the scoring portion orientation is fixed, then the device is easier to manufacture and control, but it cannot optimize fracture effectiveness for different calcification orientations
Solution Approach 1:
The scoring portion is designed with dynamic orientation adjustment capability, allowing it to be positioned at different angles relative to the commissure based on the specific calcification pattern. This dynamic feature optimizes fracture effectiveness for each case while the adjustment mechanism is designed to be simple enough to maintain manufacturing feasibility and operational control.
Data Source
AI summary
A device (30) for fracturing calcifications in heart valves includes a first heart valve treatment member (12) that extends from a first shaft (20) and which includes a scoring portion (16). A second heart valve treatment member (32) extends from a second shaft (36) and has a counterforce member (34). The second heart valve treatment member (32) and counterforce member (34) are coupled to the second shaft (36) with a brace (35) arranged to bear a force applied by scoring portion (16) to the counterforce member (34).