Rotatable Sheath Assembly for Low-Force Vascular Closure
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Solution Overview
Problem
Existing vascular closure devices face challenges in achieving proper orientation of the sheath relative to the vessel, leading to increased insertion force, trauma, and risk of unintended axial displacement during hemostasis procedures.
Innovation Solution
A vascular closure device assembly featuring a sheath with a beveled distal end and a housing that allows the sheath to rotate between configurations, facilitated by a dilator engagement mechanism, enabling the sheath to be oriented parallel to the vessel wall after insertion, reducing insertion force and trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If the sheath is inserted with the beveled distal end at an angle to facilitate penetration, then insertion force is reduced, but the sheath cannot be properly oriented parallel to the vessel wall after insertion
Solution Approach 1:
The sheath is designed with a rotatable mounting portion that allows it to rotate from an initial angled insertion configuration to a final parallel orientation relative to the vessel wall. This dynamic reconfiguration enables the sheath to first penetrate the vessel wall at an optimal angle with reduced insertion force, then rotate to achieve proper parallel orientation for subsequent hemostasis procedures.
2Ease of operation
If the sheath is oriented parallel to the vessel wall for proper anchor placement, then anchor orientation is improved, but insertion force increases and trauma occurs
Solution Approach 1:
The sheath is initially positioned at an angled configuration relative to the vessel wall during insertion, which reduces insertion force and trauma. After successful penetration, the sheath rotates to achieve parallel orientation, ensuring proper anchor placement. This preliminary angled positioning followed by rotation allows both low-force insertion and proper operational orientation.
3Ease of operation
If the sheath is fixed in position during insertion, then insertion control is improved, but rotation after insertion causes unintended axial displacement
Solution Approach 1:
The sheath assembly is segmented into a sheath main body and a rotatable sheath mounting portion. The mounting portion can rotate independently relative to the housing while the sheath main body remains axially constrained. This segmentation allows rotation for orientation adjustment without causing unintended axial displacement, maintaining both insertion control and positional reliability.
4Ease of operation
If the sheath rotates freely in the housing, then orientation adjustment is improved, but axial displacement control deteriorates
Solution Approach 1:
The interaction between the sheath mounting portion and housing is designed with asymmetric constraints: the housing includes features that permit rotation of the mounting portion while preventing axial displacement. This asymmetric mechanical interface allows free orientation adjustment during rotation while maintaining stable axial positioning, resolving the contradiction between rotational freedom and axial stability.
Data Source
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AI summary
A vascular closure device assembly, comprises a sheath comprising: a sheath main body defining a channel therethrough, a sheath engagement portion, and a sheath mounting portion located at a proximal end of the sheath main body. The assembly comprises a housing within which the sheath mounting portion is secured such that the sheath is rotatable relative to the housing, and such that the housing inhibits axial displacement of the sheath relative to the housing. The assembly also includes a dilator comprising a dilator main body, and a dilator engagement portion extending from the dilator main body towards the sheath. The dilator engagement portion is configured to engage the sheath engagement portion such that axial displacement of the dilator relative to the sheath causes the sheath to rotate relative to the housing, and wherein the housing is configured to inhibit axial displacement of the sheath during rotation.