Dynamic Dilator Sheath System for Accurate Vessel Access
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Solution Overview
Problem
Current medical device introducers for body vessels face challenges with the removal of dilators, which can alter the position of guidewires and sheaths, leading to inaccuracy and increased complexity in procedures, requiring additional navigation and imaging to correct the placement.
Innovation Solution
The introduction of a sheath and dilator system where the dilator is moveable between closed and open configurations, with lateral portions that radially move relative to the sheath axis, allowing for proximal movement of the sheath to transition the dilator from closed to open configurations without altering the guidewire or sheath position, facilitating accurate and efficient access.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the dilator is removed from the sheath, then the puncture site is dilated to allow sheath advancement, but the position of the guidewire and sheath distal ends changes, leading to placement inaccuracy
Solution Approach 1:
The dilator is designed with dynamic lateral portions that can transition between closed and open configurations. During sheath advancement, the lateral portions remain in closed configuration to maintain guidewire position. After sheath insertion, the lateral portions open to dilate the puncture site, achieving both accurate placement and effective dilation without removing the dilator.
Solution Approach 2:
The dilator with movable lateral portions is nested within the sheath lumen. The lateral portions can radially expand outward from the sheath while remaining contained within the sheath structure, allowing in-place dilation without disrupting the established guidewire-sheath-dilator nested configuration.
2Ease of operation
If the dilator is removed to dilate the puncture site, then dilation is achieved, but procedural time and complexity increase due to additional navigation and imaging requirements
Solution Approach 1:
The dynamic lateral portions allow the dilator to perform both positioning and dilation functions without removal. The transition from closed to open configuration occurs in-place after sheath advancement, eliminating the time-consuming steps of dilator removal, re-navigation, and re-positioning that would otherwise be required.
Solution Approach 2:
The invention merges the positioning function (performed by the dilator during sheath advancement) with the dilation function (performed by the lateral portions after advancement). This consolidation of functions into a single device that remains in place eliminates multiple procedural steps and reduces overall procedure time.
3Ease of operation
If the dilator is removed from the sheath, then the puncture site can be dilated, but the device complexity and procedural steps increase
Solution Approach 1:
The movable lateral portions provide a dynamic solution that maintains procedural simplicity. Instead of requiring separate dilator removal and dilation steps, the dynamic structure allows the single dilator device to perform both functions sequentially in-place, reducing procedural complexity while maintaining ease of operation.
Solution Approach 2:
The nested configuration of the dilator within the sheath, with lateral portions that can radially expand, creates an integrated system that simplifies the introduction procedure. The nested design allows the dilator to remain in place throughout the procedure, eliminating the need for multiple device manipulations and reducing overall procedural complexity.
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
This solution reduces procedural complexity and time by maintaining the accuracy of device placement, minimizing the need for additional navigation and imaging, and allowing for dilation in place, thereby enhancing the precision and efficiency of medical device insertion.
Implementation Method 1
Proximally-directed movement of the sheath along the sheath longitudinal axis relative to the dilator results in movement of the dilator from the closed configuration to the open configuration and radially-outward movement of the first and second lateral portions relative to the sheath longitudinal axis
Data Source
AI summary
Medical devices and methods of using medical devices are described herein. More particularly, the disclosure relates to introducers suitable for providing access to a body vessel and methods of using introducers. An example introducer comprises a sheath and a dilator moveably disposed within the sheath. The distal end of the dilator has a closed configuration and an open configuration and movement between the open and closed configurations can be accomplished by applying a proximally-directed force on the sheath such that the sheath moves in a proximal direction relative to the dilator.