Low-Pressure Marker Balloon for Accurate Stent Bifurcation Placement
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Solution Overview
Problem
Accurate stent placement at bifurcation sites in blood vessels is challenging due to complexity and risk of stent malposition, leading to prolonged procedures, increased radiation exposure, and higher complications, with existing methods like torus stop balloons temporarily occluding blood flow and blocking contrast media.
Innovation Solution
A guide catheter with a low-pressure arcuate marker balloon segment at its distal end allows for accurate stent positioning using angiography and tactile feedback, enabling free blood flow and reduced contrast media use, while maintaining blood flow and allowing continuous pressure monitoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a torus stop balloon is used to prevent stent malposition at bifurcation sites, then stent placement accuracy is improved, but blood flow is temporarily occluded and contrast media delivery is blocked
Solution Approach 1:
The catheter is divided into distinct functional segments: a guide catheter portion for navigation, a separate low-pressure marker balloon segment for positioning, and a high-pressure stent balloon for stent deployment. This segmentation allows the marker balloon to perform positioning without the harmful occlusion effects of traditional torus balloons, while the stent balloon handles the actual stent placement.
Solution Approach 2:
The invention changes the pressure parameter from high pressure (torus balloon) to low pressure (marker balloon segment). The low-pressure marker balloon provides sufficient tactile feedback for accurate positioning at the bifurcation site without generating enough pressure to occlude blood flow or block contrast media delivery, thus resolving the contradiction between positioning accuracy and blood flow maintenance.
2Manufacturing precision
If a torus stop balloon is used to mark bifurcation sites, then stent positioning precision is improved, but contrast media use increases due to blocking
Solution Approach 1:
By changing the pressure parameter from high to low, the marker balloon segment allows contrast media to flow freely past it during angiography, enabling accurate visualization of the bifurcation site and stent position without the need for excessive contrast media injection that would be required to overcome the blocking effect of a torus balloon.
Solution Approach 2:
The low-pressure marker balloon acts as an intermediary that provides tactile feedback for positioning without interfering with the flow of contrast media. It marks the bifurcation site effectively while allowing contrast media to pass through, thus reducing the total quantity of contrast media needed compared to traditional methods.
3Force
If traditional high-pressure methods are used for stent positioning, then stent deployment force is sufficient, but procedural complexity and radiation exposure increase
Solution Approach 1:
The catheter system is segmented into distinct functional components with specialized pressure capabilities. The low-pressure marker balloon handles positioning with simple tactile feedback, reducing procedural complexity and radiation exposure. The high-pressure stent balloon is then used only for the final stent deployment where sufficient force is required, optimizing the balance between deployment force and procedural simplicity.
Solution Approach 2:
The low-pressure marker balloon performs the preliminary action of positioning and marking the bifurcation site with simple tactile feedback, eliminating the need for complex high-pressure maneuvers during positioning. This preliminary low-pressure action reduces procedural complexity and radiation exposure, while the subsequent high-pressure stent deployment ensures adequate stent deployment force.
Data Source
AI summary
An angioplasty apparatus for facilitating accurate placement of a lumen stent for dilating a stenosis, the apparatus includes arcuate low pressure balloon segment(s) connected at a distal end of a guiding catheter with gap(s) to facilitate blood flow during a stenting procedure. Optimal positioning of a stent at a lumen bifurcation is facilitated to obviate any tendency of a stent to miss a proximal end of a stenosis branch lumen while concomitantly preventing the stent from protruding into an original lumen, such as a patient's aorta.