Bumped Dilator Tip Sheath Insertion
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
The introduction of dilator-sheath assemblies into patients often results in trauma due to damage at the transition point between the dilator and sheath, leading to resistance and snagging during insertion, and potential deformation of the sheath tip, which can cause further tissue trauma during removal.
Innovation Solution
A dilator-sheath combination featuring a radially enlarged dilation member with a proximal taper that increases in radius and a distal taper that decreases, allowing for a maximal radius at a point between the tapers, which reduces deformation and trauma by minimizing contact with the sheath tip during insertion and withdrawal.
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 performs preliminary action by pre-dilating the tissue and vessel wall before the sheath insertion. The bumped dilator tip creates a pilot path and enlarges the insertion site in advance, allowing the sheath to pass through without buckling while maintaining structural integrity
Solution Approach 2:
The bumped dilator tip acts as an intermediary between the operator and the tissue/sheath system. It mediates the insertion process by first enlarging the tissue aperture and creating a guide path, enabling the sheath to follow smoothly without direct force application that would cause buckling
2Speed
If force is applied to insert the dilator-sheath assembly, then insertion speed increases, but damage occurs at the transition point between dilator and sheath
Solution Approach 1:
The bumped dilator tip performs preliminary dilation of the tissue and vessel wall before sheath insertion. This pre-enlargement of the insertion path allows faster sheath insertion without concentrating force at the vulnerable transition point, preventing both sheath damage and tissue trauma
Solution Approach 2:
The bump changes the geometric parameters of the dilator tip, creating a radially enlarged section with specific proximal and distal tapers. This parameter modification distributes insertion forces more favorably, enabling faster insertion while preventing damage at the transition region
3Device complexity
If the transition region between dilator and sheath is made sharper, then device profile is reduced, but resistance and snagging increase during insertion
Solution Approach 1:
The bumped dilator tip performs preliminary action by creating an enlarged pilot path through tissue dilation. This pre-prepared path allows the sheath to follow with minimal resistance, enabling a sharper transition region without increasing snagging during insertion
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 design minimizes trauma and tissue damage by reducing resistance and deformation of the sheath tip, enabling smoother insertion and removal while maintaining the elastic limit of the sheath material, thus preventing permanent expansion or breakage.
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
Data Source
AI summary
A method for inserting at least a portion of a dilator and sheath assembly into a patient and for removing the dilator from the patient is disclosed. Initially, the dilator and sheath assembly is received. The dilator includes a radially enlarged dilator bump. At least the distal ends of the dilator and the sheath are inserted in an incision in the patient. A vector force is exerted to the dilator and sheath assembly to push the dilator and sheath assembly further within the patient. The dilator hub is decoupled from the sheath hub. The dilator is removed from the patient through the sheath, where the dilator bump radially stretches at least the circumferentially continuous sheath distal end during removal of the dilator from the patient.