Dilator Sheath Valve with Bridged Slot and Tear Removal
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Solution Overview
Problem
Existing dilator and sheath assemblies for catheterization are prone to disengagement during insertion, leading to blood loss and contamination risks, and lack effective sealing mechanisms.
Innovation Solution
A releasably locking dilator and sheath assembly with a valve that includes a bisecting slot and a locking mechanism, ensuring secure engagement and sealing, along with tear seams for easy removal without disrupting the catheter.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a dilator and sheath assembly is used for catheterization, then the catheter can be inserted into the blood vessel, but the assembly is prone to disengagement during insertion causing blood loss and contamination risks
Solution Approach 1:
The sheath hub is divided into two separable halves that can be torn apart along predetermined tear seams. This segmentation allows the sheath to be easily removed from the patient after catheter insertion while preventing premature disengagement during the procedure, as the two halves remain connected through the bridge structure until intentionally separated.
Solution Approach 2:
The dilator is pre-locked to the sheath assembly using a locking mechanism (such as a bayonet lock or friction fit) before insertion. This preliminary locking action ensures the components remain securely connected during the catheterization procedure, preventing disengagement and associated harmful effects.
2Ease of operation
If a sheath hub is designed to be torn apart for removal, then easy removal without disrupting catheter is achieved, but the hub lacks effective sealing mechanisms
Solution Approach 1:
The valve body is designed with a bridge structure that provides different properties in different locations: the bridge area is weakened to allow easy tearing for removal, while the sealing surface areas maintain full strength and integrity to ensure effective sealing when the valve is in the closed position.
Solution Approach 2:
The valve is designed with a resilient bridge structure that anticipates the need for both sealing and easy removal. The bridge is pre-configured with a weakened section that will fail in a controlled manner during removal, while the sealing surfaces are reinforced to maintain integrity during normal use.
3Reliability
If a valve with continuous body is used for sealing, then sealing effectiveness is improved, but the valve cannot be easily separated for sheath removal
Solution Approach 1:
The valve body is segmented into two halves connected by a bridge structure. This segmentation allows the valve to maintain sealing effectiveness when closed (as the bridge keeps the halves together) while enabling easy separation when needed for sheath removal (by tearing along predetermined seams in the bridge).
Solution Approach 2:
Different portions of the valve body have different structural properties: the bridge connection is intentionally weakened to allow easy separation, while the sealing surfaces maintain full strength and continuity to ensure effective sealing during normal operation.
Data Source
AI summary
A valve for sealing the hub of a sheath assembly is provided. The valve includes a valve body having a solid thickness extending between a proximal surface and a distal surface. A bisecting slot extends across the proximal surface of the valve body and terminates at a depth less than the thickness of the valve body such that a portion of the valve body distally of the slot defines a bridge extending between opposed halves of the valve body such that the distal surface of the valve body is substantially continuous and a central portion of the proximal surface of the valve body is concave and defines a concave proximal portion.