Medical Device Lock Preventing Premature Advancement
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Solution Overview
Problem
Current medical device systems for transseptal perforation lack effective mechanisms to prevent premature advancement of the perforating tip from the shrouded to the in-use position, potentially causing inadvertent damage, and fail to securely fix the rotational position of the transseptal perforation device relative to the sheath and dilator.
Innovation Solution
A lock system comprising an elongate spacer and a clip that positions between the dilator hub and the handle of the transseptal perforation device, preventing advancement to the in-use position until manually unlocked, and a rotary stop that fixes the rotational alignment of the device with the sheath, ensuring the perforating tip remains shrouded until intended use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If no lock mechanism is provided, then the device is simpler and easier to operate, but the perforating tip may be prematurely advanced causing inadvertent damage
Solution Approach 1:
The lock mechanism is engaged in advance during device assembly, preventing premature advancement of the perforating tip. The spacer is positioned to block the handle's proximal movement before the procedure begins, ensuring safety without requiring complex active control systems during operation.
Solution Approach 2:
The spacer acts as an intermediary mechanical element between the handle and dilator hub. It physically blocks the handle's movement toward the dilator hub, preventing the perforating tip from advancing prematurely while allowing controlled advancement when intentionally unlocked.
2Reliability
If no rotational fixation is provided, then the device has greater freedom of movement, but the rotational position cannot be securely fixed relative to the sheath and dilator
Solution Approach 1:
The rotary stop is configured to engage with the sheath or dilator at a predetermined rotational position during device insertion. This preliminary engagement ensures correct rotational alignment is established before the perforation procedure begins, eliminating the need for complex active rotational control during the procedure.
3Reliability
If the lock mechanism restricts handle movement, then the perforating tip remains shrouded for safety, but the handle cannot be moved towards the dilator hub for advancement
Solution Approach 1:
The lock mechanism transitions from a static blocking state during device insertion to a dynamic unlocked state during the procedure. The spacer remains in place to maintain safety, but the handle can be intentionally advanced when needed, providing dynamic control over the perforating tip's exposure.
Data Source
AI summary
A lock for positioning a first medical device with respect to a second medical device includes a spacer for preventing advancement of the first medical device towards the second medical device. The spacer is movable between a lock position and an unlock position. In the lock position, the spacer is moved transverse to the longitudinal axis with respect to the unlock position. The lock further includes a rotary stop integral with the spacer for fixing the rotational position of the first medical device with respect to the second medical device. The lock further includes a clip integral with the spacer and removably securable to the first medical device in a first position to secure the spacer in the unlock position, and removably securable to the first medical device in a second position to secure the spacer in the lock position.