Bumped Dilator Tip for Sheath Insertion
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Solution Overview
Problem
The introduction of dilator-sheath assemblies into patients often results in trauma due to deformation of the sheath tip during insertion and removal, leading to resistance and snagging issues, particularly at the transition point between the dilator and sheath, which can cause tissue damage and complications.
Innovation Solution
A dilator-sheath combination featuring a radially enlarged dilation member (dilator bump) with a proximal taper that increases in radius and a distal taper that decreases, allowing for pre-dilation of tissue and reducing resistance during insertion, and spontaneous reversion to prevent damage during withdrawal, utilizing a polytetramethylene glycol-based polyurethane elastomer sheath and high-density polyethylene resin dilator.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the distal tip of the sheath is made thinner to improve insertion, then insertion resistance is reduced, but the sheath tip buckles or deforms during insertion
Solution Approach 1:
The dilator bump performs pre-dilation of the tissue and vessel wall before the sheath tip passes through. This preliminary action enlarges the insertion pathway in advance, allowing the sheath to pass through with reduced resistance without requiring the distal tip to be excessively thin, thereby preventing buckling and deformation
Solution Approach 2:
The dilator bump acts as an intermediary element between the dilator and the sheath tip. It temporarily occupies the insertion site and performs the dilation function, allowing the sheath tip to follow through the pre-created pathway without direct contact with the undilated tissue, thus avoiding deformation
2Productivity
If force is applied to insert the dilator-sheath assembly, then insertion is achieved, but the sheath transitions deform and cause trauma to the patient
Solution Approach 1:
The dilator bump performs pre-dilation of the tissue and vessel wall before the sheath passes through. This preliminary enlargement of the insertion pathway reduces the force required for sheath insertion and prevents tissue trauma that would otherwise occur during forced insertion
Solution Approach 2:
The dilator bump acts as a cushioning element that absorbs insertion forces and distributes them over a larger area of tissue. By pre-enlarging the pathway and providing a tapered transition, it cushions the sheath tip against direct impact with tissue, preventing deformation and trauma
3Ease of operation
If the transition region is made sharper to reduce resistance, then insertion smoothness is improved, but snagging occurs at the transition point
Solution Approach 1:
The dilator bump features a curved, rounded surface geometry rather than a sharp angular transition. This curvature allows the sheath tip to smoothly follow the contour of the bump, eliminating snagging points while maintaining insertion smoothness through the transition region
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution minimizes trauma and tissue damage by reducing resistance during insertion and ensuring smooth withdrawal, maintaining the elastic limit of the sheath and preventing deformation, thus enhancing the safety and efficacy of vascular access procedures.
Implementation Method 1
The bumped dilator of the present disclosure functions through pre-dilation of the tissue and vessel wall so that the transition at the distal sheath tip encounters less resistance upon insertion
Implementation Method 2
utilizing a polytetramethylene glycol-based polyurethane elastomer sheath
Data Source
Figure 1A~1B
Figure 1C~1D
Figure 2A~2C
AI summary
The disclosure provides a dilator with a tip that has a bump, an assembly comprising the dilator and a sheath, and methods of use, where the bump on the tip is configured to reduce or minimize damage to the sheath, and to prevent trauma to a patient during insertion or removal.