Radially Expandable Dilator Tip for Minimally Invasive Sheath Insertion
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Solution Overview
Problem
Minimally invasive medical procedures, such as transcatheter aortic valve replacement, face challenges with the insertion profile of delivery sheaths due to the need for a solid dilator tip to pass through the prosthetic valve, limiting their use in smaller diameter vessels.
Innovation Solution
A percutaneous assembly featuring a radially expandable dilator tip and an elongated control member that adjusts between expanded and contracted configurations, allowing for conformability to the sheath and enabling passage through smaller vessels while accommodating medical devices like heart pumps.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a solid dilator tip is used to pass through the prosthetic valve, then the valve can be deployed, but the insertion profile of the delivery sheath increases, limiting use in smaller vessels
Solution Approach 1:
The dilator tip is designed with a radially expandable member that can dynamically change its configuration between contracted and expanded states. In the contracted state, the dilator has a small profile for insertion through the puncture site. In the expanded state, the dilator provides sufficient structural support to push the prosthetic valve through the vessel and into position, thereby resolving the contradiction between insertion profile and deployment capability
Solution Approach 2:
The radially expandable member changes its physical parameters (radial dimension, structural rigidity) from a compressed low-profile state during insertion to an expanded high-support state during valve deployment. This parameter transformation allows the same device to satisfy both the small insertion profile requirement and the structural support requirement for valve delivery
2Reliability
If nested sheaths are used to deliver the prosthetic valve, then the valve can be delivered, but the insertion profile increases, limiting use in smaller diameter vessels
Solution Approach 1:
The invention extracts and removes the traditional nested sheath structure from the delivery system. Instead of using multiple nested sheaths, the design employs a single sheath with a radially expandable dilator tip that provides the necessary structural support without requiring additional nested layers, thereby reducing the overall insertion profile while maintaining valve delivery capability
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
Enables the deployment of medical devices in smaller vessels by reducing the insertion profile and facilitating the passage of the dilator tip through the prosthetic valve, enhancing the applicability of minimally invasive procedures.
Implementation Method 1
the radially expandable member being adjustable in an expanded configuration in which the expandable end portion is configured to conform to the distal end portion of the tubular wall when engaged thereto, and a contracted configuration in which the expandable end portion has a contracted outer diameter that is smaller than the inner diameter of the lumen of the tubular wall
Data Source
AI summary
A percutaneous assembly is provided with a percutaneous sheath and a percutaneous dilator tip. The percutaneous sheath has a tubular wall extending to a distal end portion thereof and defines a lumen having an inner diameter. The percutaneous dilator tip includes a radially expandable member and an elongated control member. The radially expandable member is either removably engageable or fixedly attached to the distal end portion of the tubular wall and is also adjustable in an expanded and a contracted configurations. The elongated control member is disposed longitudinally along the tubular wall, positioned eccentrically relative to the lumen, and is operatively coupled to the radially expandable member for adjusting same in at least one of the expanded and the contracted configurations. A percutaneous sheath is also provided as kits.