Anchored Dilator Cuff for Sheathless Vascular Access
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Solution Overview
Problem
Existing vascular access and delivery methods, such as the Seldinger technique, require multiple instruments and steps, leading to increased labor, time, infection risk, and vessel trauma, particularly in smaller vessels like the wrist, due to the use of introducer sheaths and guide catheters that occupy valuable vessel space and create sharp edges.
Innovation Solution
An anchored dilator system that integrates a dilator with a medical device, like a guide catheter, using an anchor cuff that transitions between configurations to provide a smooth, unified profile, minimizing the need for separate introducer sheaths and reducing vessel trauma by concealing sharp edges.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple instruments (needle, guidewire, dilator, introducer sheath) are used in successive steps for vascular access, then vascular access can be achieved, but the procedure increases labor, time, infection risk, and vessel trauma
Solution Approach 1:
The patent combines the dilator and guide catheter into a single integrated device with a dilator tip that includes both the dilating element and the guide catheter portion as unified components, eliminating the need for separate introducer sheaths and reducing the number of procedural steps
Solution Approach 2:
The dilator tip serves multiple functions: it penetrates the vessel wall, dilates the access site, and guides the catheter through the vessel, combining functions that traditionally required separate instruments into a single multi-functional device
2Ease of operation
If introducer sheaths and guide catheters are used to provide access through vasculature, then catheter delivery is enabled, but valuable vessel space is occupied and sharp edges create vessel trauma
Solution Approach 1:
The dilator tip features a tapered, curved design that replaces sharp edges with gradual transitions, reducing mechanical trauma to the vessel wall during insertion and navigation through the vasculature
Solution Approach 2:
The guide catheter portion of the dilator tip is designed with flexible materials and a streamlined profile that conforms to the vessel wall, minimizing disruption to blood flow and reducing trauma compared to rigid introducer sheaths
3Reliability
If separate dilator and guide catheter are delivered in sequential steps, then vascular access is established, but procedure time and labor increase
Solution Approach 1:
The dilator and guide catheter are merged into a single integrated dilator tip device that performs both dilating and guiding functions simultaneously, eliminating the time required for sequential insertion of separate instruments
Solution Approach 2:
The guide catheter is pre-integrated onto the dilator tip before the procedure, so that when the dilator is inserted and deployed, the guide catheter is already in position ready for immediate catheter delivery, eliminating setup time
4Ease of operation
If introducer sheath is used as intermediate passage, then catheter delivery is facilitated, but the profile available for medical devices is reduced
Solution Approach 1:
The patent extracts and eliminates the intermediate introducer sheath from the system by integrating the guide catheter directly onto the dilator tip, thereby removing the space-consuming intermediate component and maximizing the profile available for therapeutic devices
Data Source
Figure 1
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Figure 3A~3B
AI summary
An anchored dilator includes a push tube having proximal and distal push tube portions. A dilator tip is coupled with the distal push tube portion and is configured for selectable coupling with a catheter. The dilator tip includes an anchor cuff having a cuff interface. The anchor cuff is configured to transition between a shuttle configuration having a shuttle profile and an anchored configuration having an anchored profile larger than the shuttle profile. A cuff operator assembly is configured to transition the anchor cuff between the anchored and shuttle configurations. The cuff operator assembly includes a cuff operator movably coupled with the dilator tip, and an operator shaft coupled with the cuff operator. The operator shaft extends toward the proximal push tube portion. Actuation of the cuff operator with the operator shaft transitions the anchor cuff between the shuttle configuration and the anchored configuration.