Pre-shaped Catheter Arc Navigation
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Solution Overview
Problem
Intravascular catheters face difficulties in navigating tortuous vascular pathways with extreme turning or bending dimensions, making access to target locations within the body challenging due to lack of sufficient flexibility and steerability.
Innovation Solution
The development of pre-shaped vascular devices with specific geometric configurations that transition under load, featuring arcs of 180 degrees with varying radii and cut patterns, allowing for increased flexibility and steerability to access tortuous pathways, including radiopaque segments for improved imaging.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a catheter is made more flexible to navigate tortuous pathways, then steerability and access to target locations improve, but structural stability and support for therapeutic devices deteriorate
Solution Approach 1:
The catheter body is divided into multiple segments with different flexibility characteristics. The pre-shaped segment is separated from the proximal and distal segments, allowing each segment to have optimized properties. The pre-shaped segment provides flexibility for navigation, while other segments maintain structural stability.
Solution Approach 2:
Different segments of the catheter are assigned different mechanical properties. The pre-shaped segment has specific geometric configuration (180-degree arc with radius ≥1mm) optimized for flexibility and steerability, while maintaining adequate radial strength to support therapeutic devices at the target location.
2Ease of operation
If the pre-shaped segment has a small radius arc for better access to tight pathways, then flexibility improves, but the ability to maintain geometric configuration under load deteriorates
Solution Approach 1:
The patent specifies precise geometric parameters for the pre-shaped segment, including a 180-degree arc with radius of at least 1mm (preferably at least 2mm). These parameter ranges optimize the balance between flexibility for navigation and shape retention under operational loads of 6-14 gF.
Solution Approach 2:
The pre-shaped segment incorporates a controlled curvature (180-degree arc) that provides the necessary flexibility to navigate tortuous vasculature while maintaining a predictable geometric configuration. The specific curvature parameters ensure the segment can bend to access side branches while retaining its shape when deployed.
3Ease of operation
If the arc center is laterally offset from the longitudinal axis for improved steering capability, then steerability improves, but device complexity increases
Solution Approach 1:
The pre-shaped segment features an asymmetric geometric configuration where the arc center is laterally offset from the longitudinal axis of the proximal segment. This asymmetric design provides inherent steering capability, allowing the catheter to naturally navigate curves without requiring complex active control mechanisms.
Data Source
Figure 1A~1B
Figure 2A~2B
Figure 3A~3B
AI summary
A medical device (10), including a catheter body (12) defining a proximal segment (14), a distal segment (16) , and a lumen (18) therethrough, where the distal segment (16) includes a pre-shaped segment having a first geometric configuration in an unloaded state, and a second geometric configuration in a loaded state; where in the first geometric configuration, the pre-shaped segment (16) includes an arc of 180 degrees having a radius of at least 1 mm, and where a center of the arc is laterally offset from a longitudinal axis (20) of the proximal segment (14) of the catheter body (12).