Conical Balloon Catheter for Subintimal Re-entry
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Solution Overview
Problem
Chronic total occlusions (CTOs) in blood vessels pose challenges for recanalization, as it is difficult or impossible to pass through the occlusion with medical devices in an antegrade direction, and re-entering the true lumen from the subintimal space can be problematic.
Innovation Solution
A balloon catheter with a conical inflatable balloon, secured to a catheter shaft, is advanced into a subintimal space distal to the occlusion, inflated to orient the guidewire lumen towards the true lumen, allowing a penetration member to re-enter the vessel lumen, facilitating recanalization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a conventional catheter is used to navigate the subintimal space, then the catheter can be advanced around the occlusion, but the guidewire lumen cannot be properly oriented towards the true lumen for re-entry
Solution Approach 1:
The balloon is designed with a conical shape that allows it to dynamically orient the guidewire lumen towards the true lumen when inflated in the subintimal space. The conical geometry creates an automatic directional alignment function that simplifies the re-entry maneuver without requiring complex active control mechanisms
Solution Approach 2:
The conical balloon shape with its curved surface provides the necessary geometry to deflect and orient the guidewire lumen towards the true lumen. The curved conical surface naturally guides the penetration member in the desired direction, eliminating the need for complex angular adjustment mechanisms
2Productivity
If a penetration member is advanced to re-enter the true lumen from the subintimal space, then recanalization can be achieved, but the procedure becomes difficult and time-consuming
Solution Approach 1:
The catheter is pre-positioned in the subintimal space with the conical balloon ready for inflation. The balloon is inflated in advance to create the oriented guidewire lumen configuration before the penetration member is advanced, thereby simplifying the re-entry action and reducing procedural time
Solution Approach 2:
The conical balloon acts as an intermediary device that facilitates the transition from subintimal space to true lumen. By inflating the balloon, the guidewire lumen is oriented towards the true lumen, making the penetration and re-entry process more efficient and less difficult
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
The balloon catheter effectively navigates the subintimal space to re-enter the true lumen of the blood vessel, enabling recanalization of occluded vessels by deflecting the guidewire lumen towards the vessel lumen, thus overcoming the difficulties of CTOs.
Implementation Method 1
an inflatable balloon having a proximal waist secured to the catheter shaft and a distal waist secured to the catheter shaft
Data Source
Figure 1
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AI summary
A balloon catheter 10 including a catheter shaft 12 and an inflatable balloon 20 secured to a distal end region of the catheter shaft. The inflatable balloon has a generally conical shape in a fully inflated configuration having a proximal conical portion 42 that tapers away from the central longitudinal axis in a distal direction from a proximal waist of the balloon and a distal conical portion 46 that tapers toward the central longitudinal axis in a distal direction toward a distal waist of the balloon, with a radially outermost extent 44 of the balloon located between the proximal conical portion and the distal conical portion. The proximal conical portion, the distal conical portion and/ or the radially outermost extent of the balloon has an elliptical cross- section taken in a plane perpendicular to the central longitudinal axis of the catheter shaft.