Introducer Sheath Locking Dilator for Seal-Preserving Fixation
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Solution Overview
Problem
Existing introducer sheath assemblies struggle to lock a surgical implement without disrupting the fluid seal between the introducer sheath valve and the implement, which is crucial for maintaining a leak-proof environment during medical procedures.
Innovation Solution
A locking mechanism is introduced that allows for the releasable axial locking of the introducer sheath and surgical implement, using a lock knob that rotates independently of the hub, ensuring the seal is maintained without causing rotation of the implement relative to the sheath and valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a locking mechanism is added to lock the surgical implement to the introducer sheath, then the reliability of the connection is improved, but the device complexity increases
Solution Approach 1:
The locking mechanism merges the locking function with the existing introducer sheath assembly by integrating the lock knob and locking surface into the valve structure. The lock knob is positioned on the valve body and engages with a locking surface on the surgical implement, creating a unified locking system that does not require separate locking components outside the existing assembly.
Solution Approach 2:
The valve structure serves multiple functions: it controls fluid flow during the procedure and simultaneously provides the locking mechanism through its lock knob and locking surface. This multi-functionality reduces the need for additional dedicated locking components, thereby limiting the increase in device complexity while improving connection reliability.
2Reliability
If the lock knob is rotated to engage the locking mechanism, then the axial locking is achieved, but the surgical implement may rotate relative to the sheath and valve
Solution Approach 1:
The locking mechanism is segmented into two independent rotational elements: the lock knob that rotates on the valve body, and the surgical implement that remains stationary relative to the sheath. The lock knob's rotation is decoupled from the surgical implement's orientation through the locking surface geometry, allowing independent control of locking engagement without causing implement rotation.
Solution Approach 2:
The locking surface acts as an intermediary between the lock knob and the surgical implement. It translates the rotational motion of the lock knob into axial locking force while preventing rotational transmission to the surgical implement. This intermediary mechanism ensures that the implement remains properly oriented while achieving secure locking.
3Strength
If the locking mechanism uses direct mechanical engagement, then the locking strength is improved, but the fluid seal between the valve and surgical implement may be disrupted
Solution Approach 1:
The locking function is extracted from the main fluid sealing path by positioning the lock knob and locking surface at locations that do not interfere with the seal between the valve and surgical implement. The locking mechanism operates independently from the sealing interface, allowing strong mechanical engagement without compromising fluid seal integrity.
Solution Approach 2:
Different regions of the valve and surgical implement assembly have specialized local qualities: the sealing surfaces maintain fluid tightness through precise mating, while the locking surfaces provide mechanical engagement through the lock knob. This local differentiation allows simultaneous achievement of strong locking and reliable sealing without mutual interference.
Data Source
AI summary
An introducer assembly includes a valve having a first end and an opposite second end; a sheath fixedly secured to and extending axially from one of the first and second ends of the valve; a dilator extending through the valve and sheath; and a lock knob rotatable between locked and unlocked positions to releasably axially lock the tool relative to the sheath without causing corresponding rotation of the tool therewith.