Low-Pressure Anchor Balloon for Accurate Stent Placement
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Solution Overview
Problem
Accurate stent placement at bifurcation sites in the vascular system is challenging due to complexity, leading to prolonged procedures, increased radiation exposure, and higher risks of complications, with existing methods often occluding blood flow and requiring excessive contrast media.
Innovation Solution
A low-pressure arcuate anchor and/or marker balloon segment is used at the proximal end of the stent balloon, allowing free blood and contrast media flow, facilitating accurate stent positioning using angiography and tactile feedback, and reducing the need for high-pressure inflation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a high-pressure balloon is used to deploy the stent, then the stent can be effectively expanded to open the stenosis, but the blood flow and contrast media flow are occluded during the procedure
Solution Approach 1:
The balloon catheter is divided into two separate balloons: a low-pressure anchor/marker balloon and a high-pressure stent deployment balloon. The anchor balloon is inflated first to secure positioning and allow blood flow, then the deployment balloon is inflated to expand the stent. This segmentation allows the two functions to be performed independently without interfering with each other's harmful effects.
Solution Approach 2:
The low-pressure anchor balloon acts as an intermediary that facilitates accurate stent positioning without occluding blood flow. It provides tactile feedback and radiographic markers to guide the deployment balloon to the correct location, enabling precise stent placement while maintaining continuous blood flow through the vessel.
2Measurement precision
If traditional angiography methods are used to confirm stent position, then the stent can be positioned accurately, but excessive contrast media is required
Solution Approach 1:
The anchor balloon serves as a radiopaque intermediary that provides visible markers under fluoroscopy to confirm stent positioning. These markers eliminate the need for extensive contrast media injection, as the balloon's radiopaque elements provide clear visual confirmation of the stent's location and orientation.
Solution Approach 2:
The patent replaces the traditional contrast media-based visualization system with a mechanical/radiopaque marker system integrated into the anchor balloon. This substitution provides more reliable and clearer positioning information with minimal or no contrast media, reducing the quantity of substance required.
3Reliability
If the procedure is performed at bifurcation sites using conventional methods, then the stenosis can be treated, but the procedural complexity and time are increased
Solution Approach 1:
The patent combines multiple functions into a single integrated catheter system: the anchor balloon provides both positioning and marking functions, while the deployment balloon handles stent expansion. This merging of functions into one device reduces procedural complexity compared to using separate devices for each function, while maintaining reliability at complex bifurcation sites.
Data Source
AI summary
An angioplasty apparatus and method including a balloon stent, for facilitating accurate placement of a lumen stent for dilating a stenotic site, the apparatus includes arcuate, low pressure, anchor and/or marker and guide balloon segment(s) connected to a stent deployment catheter at at least one of a proximal and distal end of a wire mesh stent with circumferential gaps in the anchor and/or marker balloon segment or segments to facilitate blood flow and contrast media during a stenting procedure. Optimal positioning of a stent at a stenotic lumen site is facilitated by selective injection of marker fluid into one or more low pressure, anchor and/or marker balloon segment(s).