Hubless Dilator for Vascular Sheath Exchange
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Solution Overview
Problem
Existing methods for exchanging vascular sheaths during procedures risk losing the original vessel access point and cause excessive patient blood loss due to the lack of stiffness in guidewires and the potential for vessel perforation when using stiff guide rods.
Innovation Solution
A method involving a hubless or removable-hub dilator with a lumen to receive a guidewire, which is used to facilitate the exchange of sheaths by maintaining the access point and preventing vessel perforation, utilizing a dilator with a tapered portion and radiopaque elements to ensure precise placement and visibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a guidewire is used to channel the second introducer sheath, then the exchange process is simpler, but the risk of losing the original vessel access point increases due to insufficient stiffness
Solution Approach 1:
The patent combines a guidewire and a dilator into a single integrated assembly. The dilator is positioned over the guidewire, creating a composite structure that leverages the flexibility and vessel-tracking capability of the guidewire while adding the stiffness and structural support of the dilator. This merged assembly maintains the vessel access point reliably during sheath exchange without requiring complex separate maneuvers.
2Reliability
If a stiff guide rod is used to facilitate sheath exchange, then the access point is maintained better, but the risk of vessel perforation increases
Solution Approach 1:
The dilator assembly incorporates a tapered distal end with a gradually increasing diameter. This local variation in geometry allows the distal tip to navigate the vessel tract safely with minimal risk of perforation, while the proximal portion provides sufficient stiffness to maintain the access point. The radiopaque band at the distal end enhances local visibility for precise positioning without requiring excessive stiffness throughout the entire assembly.
3Reliability
If manual pressure is applied to seal the puncture hole, then sealing can be achieved, but the procedure time increases and patient comfort decreases
Solution Approach 1:
The dilator assembly is designed to maintain the puncture hole in a controlled, patent state throughout the sheath exchange procedure. By keeping the hole open and properly positioned with the dilator in place, the system prepares the access site for immediate sealing after device removal, eliminating the need for prolonged manual compression and reducing overall procedure time.
Data Source
AI summary
A method for replacing a first sheath, whose distal end is positioned inside a vessel and whose proximal end is positioned outside the skin of a patient, with a second sheath may involve inserting a dilator over a guidewire and into the first sheath until a distal end of the dilator and a distal end of the guidewire are positioned inside the vessel. The dilator may be hubless or include a removable hub, and may define an external channel configured to receive a second guidewire. The method may further involve removing the first sheath, thereby leaving the dilator and the guidewire in place. After removing the first sheath, a second sheath may be passed over the dilator and the guidewire until the distal end of the second sheath is positioned inside the vessel. The method may further involve removing the dilator and the guidewire, leaving the second sheath in place.