Dilator Tip Transition Strain Relief
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Solution Overview
Problem
Introducer sheath assemblies with stiffener tubes often experience kinking or buckling during insertion due to the transition between the stiffening tube and the dilator tip, leading to increased procedure time and cost as multiple assemblies may be needed to complete a procedure without causing tissue damage.
Innovation Solution
A dilator with a stiffened shaft and a flexible tip, where the transition between the stiffener and the tip is positioned within the catheter sheath, providing strain relief and minimizing kinking, and a sleeve that flows back to form a contact surface with the stiffener tube for additional strength.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a stiffener tube is used to provide rigidity to the dilator, then the dilator can be inserted into the patient, but the transition between the stiffening tube and the dilator tip causes kinking or buckling
Solution Approach 1:
The patent applies local quality by creating a flow back region with different material properties than the rest of the dilator. This localized area has increased material density and structural reinforcement specifically at the transition zone, providing enhanced kinking resistance where needed while maintaining the overall flexibility and rigidity of the dilator shaft.
Solution Approach 2:
The patent employs composite materials by combining the base dilator material with a flow back region that has different physical properties. The flow back region creates a composite structure where materials with different characteristics are integrated to provide both the rigidity needed for insertion and the kinking resistance required at the transition point.
2Object-affected harmful factors
If the dilator tip is made resilient to prevent tissue damage, then patient safety is improved, but the transition zone becomes more prone to kinking during insertion
Solution Approach 1:
The flow back region creates a localized area with enhanced structural properties specifically at the vulnerable transition zone. This local reinforcement allows the dilator tip to remain resilient for patient safety while the flow back region provides the necessary strength to prevent kinking during insertion.
Solution Approach 2:
The flow back region acts as a pre-reinforced cushioning zone that anticipates and prevents kinking before it can occur. By strengthening the transition area in advance, the design protects against the harmful effect of kinking while maintaining the resilient properties needed for safe tissue interaction.
3Reliability
If multiple introducer sheath assemblies are used to complete a procedure, then the risk of tissue damage is reduced, but procedure time and cost increase
Solution Approach 1:
The patent extracts and eliminates the weak transition zone that causes kinking and procedure failure. By removing this vulnerability through the flow back region design, the dilator can complete the entire procedure in a single insertion, eliminating the need to switch between multiple assemblies and thereby reducing procedure time.
Solution Approach 2:
The flow back region enables continuous successful insertion by preventing kinking throughout the entire procedure. This ensures the dilator maintains its functionality from initial insertion through to the completion of the procedure, eliminating interruptions and the need for replacement assemblies.
Data Source
AI summary
The present invention is directed to a dilator having a stiffened shaft for use as part of an introducer sheath assembly. The dilator includes a stiffener tube and a tip of the dilator which extends distally to the dilator stiffener tube. The transition between the stiffener tube and the tip of the dilator is positioned such that when the dilator is positioned within the catheter sheath, the transition is also positioned within the catheter sheath. By positioning the transition between the stiffener tube of the dilator and the tip of the dilator inside the catheter sheath, the catheter sheath can provide strain relief subsequent to lateral movement of the tip of the dilator in a manner that can prevent kinking of the dilator tip at the transition between the stiffener tip and the tip of the dilator.