Transcatheter Handle Locking Arm for Stable Valve Positioning
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Solution Overview
Problem
Existing transcatheter delivery systems face challenges in maintaining the axial position of a prosthetic valve at the target implantation site during retraction of the outer shaft, leading to unwanted displacement of the prosthetic valve due to axial movement of the handle, which requires manual readjustment.
Innovation Solution
A locking mechanism is introduced that couples the handle of the delivery apparatus to the introducer sheath, locking the axial position of the handle relative to the sheath, preventing axial movement during capsule retraction, thus maintaining the prosthetic valve's position at the target site.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If the outer shaft is retracted to uncover the prosthetic valve, then the prosthetic valve is exposed for implantation, but axial movement of the handle causes displacement of the prosthetic valve from its intended position
Solution Approach 1:
The locking mechanism is engaged before capsule retraction to pre-prevent handle movement. The locking arm is positioned and secured to the handle in advance, so that when the capsule is retracted, the handle cannot move axially, thereby preventing prosthetic valve displacement.
Solution Approach 2:
The locking arm acts as an intermediary mechanical element between the handle and the delivery system. It physically connects to the handle and engages with the delivery system structure, serving as a mediator that transfers and constrains axial forces, preventing handle movement during capsule retraction.
2Adaptability or versatility
If the handle is allowed to move axially during capsule retraction, then the operator can adjust the position, but the prosthetic valve may shift from its original position requiring readjustment
Solution Approach 1:
The locking mechanism provides dynamic control of handle movement. Before locking, the handle is free to move for positioning; after locking, the handle position is fixed for stability during capsule retraction. This dynamic transition between free movement and constrained movement resolves the contradiction between adjustability and stability.
Solution Approach 2:
The handle is positioned and adjusted to the desired location before the locking mechanism is engaged. This preliminary positioning ensures the prosthetic valve is at the correct location, and subsequent locking maintains this position without requiring readjustment.
3Manufacturing precision
If a locking mechanism is introduced to fix the handle position, then axial movement is prevented, but the device complexity increases
Solution Approach 1:
The locking mechanism is segmented into distinct functional components: a locking arm for engagement, a fixing member for attachment to the handle, and a release mechanism. This segmentation allows each component to perform its specific function efficiently while keeping the overall structure manageable and not excessively complex.
Solution Approach 2:
The locking mechanism is designed to be self-contained and self-operating to the extent possible. The locking arm automatically engages with the handle structure, and the release mechanism can be actuated by the operator without requiring additional external devices or complex control systems, thereby minimizing added complexity.
Data Source
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AI summary
A locking mechanism for a transcatheter delivery system is disclosed. As one example, the locking mechanism may comprise a first fixing member configured to be coupled to an introducer sheath, a second fixing member configured to be coupled to a handle of a delivery apparatus, and a locking arm configured to be removably coupled at a first end to one of the first fixing member and the second fixing member and fixedly or removably coupled at a second end to another one of the first fixing member and the second fixing member, wherein the locking arm is moveable between a first position where an axial position of the second fixing member is not fixed relative to the first fixing member via the locking arm and a second position where the axial position of the second fixing member is fixed relative to the first fixing member via the locking arm.