Vascular Access Device for Subintimal Angioplasty
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Solution Overview
Problem
Current methods for treating occluded peripheral arteries are limited in their ability to effectively access and bypass occlusions in vascular disease, particularly in providing a second entry point remote from the first entry point to restore blood flow.
Innovation Solution
The development of an access device comprising a vascular catheter with a guide tube and stylet, where the guide tube has a preformed curve and a stylet actuator, allowing for subintimal angioplasty by creating a blood flow lumen through the subintimal space along the occlusion, facilitating access beyond the occlusion and forming a new lumen.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If conventional methods are used to access occluded arteries, then the procedure is simple, but the ability to provide a second entry point remote from the first entry point is limited
Solution Approach 1:
The access device is divided into distinct functional segments: a guide tube for navigating to the occlusion, a stylet for creating the subintimal space, and a balloon for angioplasty. This segmentation allows each component to perform its specific function independently, enabling the complex capability of providing a second entry point while keeping individual components relatively simple.
Solution Approach 2:
The stylet is nested within the guide tube, and both are contained within the vascular catheter. This nested arrangement allows the device to achieve complex functionality (creating subintimal access) while maintaining a compact structure that can be delivered through conventional vascular access routes.
2Reliability
If subintimal angioplasty is performed to bypass occlusion, then blood flow is restored, but the difficulty of detecting and measuring the occlusion increases
Solution Approach 1:
The guide tube acts as an intermediary that navigates to the occlusion and provides a controlled entry point into the subintimal space. This intermediary structure allows the operator to precisely target the occlusion and create a reliable bypass while using fluoroscopic imaging to detect and measure the occlusion location and characteristics.
Solution Approach 2:
Contrast dye is injected to visualize the occlusion and the newly created blood flow pathway under fluoroscopy. The contrast material changes the radiographic appearance, making the occlusion and the restored flow path detectable and measurable, thereby enabling reliable guidance of the subintimal angioplasty procedure.
3Ease of operation
If a stylet is used to create subintimal space, then access beyond occlusion is facilitated, but the force required to pierce vascular tissue increases
Solution Approach 1:
The guide tube is advanced first to establish a controlled pathway and positioning before the stylet is deployed to create the subintimal space. This preliminary action of guide tube advancement reduces the force required for the subsequent stylet puncture by pre-establishing the anatomical trajectory and providing a target for the stylet tip.
Solution Approach 2:
The guide tube serves as a mediator that facilitates the stylet's interaction with the vascular tissue. It provides a protected pathway and precise positioning, allowing the stylet to create the subintimal space with controlled force rather than requiring high force to blindly pierce the vessel wall.
Data Source
AI summary
Methods and devices for treating occlusive peripheral vascular diseases are described. The devices can include an access catheter having a guidewire lumen and stylet lumen, a guide tube having a curved distal end, a stylet, and an actuator handle. The methods describe techniques for using the described devices for performing vascular procedures, such as subintimal angioplasty.