Hypotube Cut Pattern Balloon Catheter Shaft
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Solution Overview
Problem
Existing rapid-exchange balloon catheter systems face challenges in achieving a balance of flexibility, pushability, and low profile while maintaining guidewire stability and ease of exchange during vascular procedures, particularly in navigating tight lesions and small vessels.
Innovation Solution
The design incorporates a hypotube with a cut pattern extending from the proximal hub to the balloon, providing optimized flexibility, torsional strength, and pull strength, along with a lubricious guidewire lumen, which enhances the catheter's ability to track through tortuous vessels and reduces friction, allowing for efficient exchange without the need for additional stiffening wires.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a hypotube with cut pattern is used to improve flexibility and torsional strength, then the catheter can navigate tight lesions better, but the structural integrity may be compromised
Solution Approach 1:
The hypotube is divided into multiple segments through the cut pattern, creating discrete sections that can flex and rotate independently. This segmentation allows the catheter to navigate tight lesions and tortuous vessels while maintaining overall structural integrity through the distributed design.
Solution Approach 2:
The cut pattern creates regions of varying flexibility along the hypotube length, with different sections having different mechanical properties. This local quality variation allows the catheter to be flexible where needed for navigation while maintaining strength in other regions.
2Productivity
If the guidewire lumen is made lubricious to reduce friction, then exchange efficiency improves, but the guidewire stability may be reduced
Solution Approach 1:
The lubricious coating is applied selectively to specific regions of the guidewire lumen rather than the entire length. This creates zones of reduced friction for efficient exchange while maintaining adequate grip and stability in other regions where the coating is absent or less pronounced.
3Strength
If the hypotube extends to the balloon to provide pull strength, then catheter control improves, but the profile size increases
Solution Approach 1:
The hypotube is designed as a thin-walled flexible structure that provides adequate pull strength and torque transmission while maintaining a low profile. The flexibility of the thin-walled design allows it to conform to the catheter assembly without significantly increasing the overall diameter.
Data Source
Figure 1
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Figure 6~9
AI summary
A balloon catheter or stent delivery system for medical treatment of a patient has a proximal hub (12), a balloon (16), and an improved shaft design. The catheter shaft (14) has a rapid-exchange configuration, and a tubular outer body (24) that includes a hypotube (48) extending from the catheter proximal end to a position at or near a proximal leg of the balloon. An inner tubular body (26) defines a guidewire lumen (28) extending from a distal guidewire port (18) at the catheter distal end to a proximal port located at a position between the balloon and the hub. The hypotube has an aperture for accepting the inner body proximal end, and a circumferential cut pattern. The cut pattern adds flexibility, and may extend from the hypotube distal end to a position proximal of the proximal guidewire port.