Shaped Catheter Tip with Durometer Gradient for Guidewire Tracking
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Solution Overview
Problem
Existing catheters face challenges in navigating through tortuous vasculature due to the need for a flexible distal section that can follow vessel twists and turns while maintaining torque transmission and support for longitudinal advancement, particularly when using shaped catheter tips to direct guidewires into branch vessels.
Innovation Solution
A vascular catheter system with a flexible main body and a shaped tip, comprising multiple sections with varying durometers and materials, including a polymer and tungsten, designed to deviate from and align with the longitudinal axis when a guidewire is inserted, allowing for smoother navigation through tortuous vasculature.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a catheter uses a shaped tip to navigate tortuous vasculature, then maneuverability through turns is improved, but the catheter may kink or fail to track smoothly over the guidewire
Solution Approach 1:
The catheter tip is constructed with multiple sections having different durometers (hardness values). The intermediate section has a durometer between the softer distal tip section and the harder proximal section, creating a gradient structure. This local variation in material properties allows the tip to be flexible enough to navigate turns while maintaining structural integrity to prevent kinking during guidewire tracking.
Solution Approach 2:
The catheter tip employs a composite construction with multiple materials of varying durometers bonded together in sequential sections. This composite structure combines the flexibility needed for maneuverability with the rigidity required for stable guidewire tracking, resolving the contradiction between ease of operation and reliability.
2Adaptability or versatility
If a catheter has a flexible distal section to follow vessel twists and turns, then adaptability to tortuous anatomy is improved, but torque transmission and support for longitudinal advancement deteriorate
Solution Approach 1:
The catheter shaft is divided into multiple segmented sections with progressively varying durometers from distal to proximal. This segmentation allows each section to contribute differently to the overall performance - distal sections provide flexibility for adaptability while proximal sections provide rigidity for torque transmission, eliminating the need for a single compromise design.
Solution Approach 2:
The durometer parameter is systematically changed across different sections of the catheter tip. By creating a gradient of stiffness values, the catheter achieves both high adaptability in the flexible distal regions and adequate torque transmission in the stiffer proximal regions, resolving the contradiction between these two requirements.
3Ease of manufacture
If a catheter uses a single-material construction, then manufacturing simplicity is maintained, but the ability to provide gradient flexibility from rigid to flexible sections deteriorates
Solution Approach 1:
Instead of using a single material throughout, the catheter employs local quality variations with different materials at different locations along the catheter tip. This allows precise control over the flexibility gradient while using standard bonding techniques that maintain manufacturing feasibility despite the increased material diversity.
Data Source
Figure 1~2
Figure 3A~3B
Figure 4A~4E
AI summary
A vascular catheter system is provided with a flexible main body and a flexible shaped tip. The tip is located at the distal end of the main body and has at least a portion configured to deviate from a longitudinal axis when in a relaxed state and towards alignment with the longitudinal axis when a guidewire is extended through a lumen of the shaped tip. The shaped tip is no longer than 1 cm and includes at least three sections. The second section is located distally from the first section, and the third section is located distally from the second section. The second section includes a first material having a first durometer and a second material having a second durometer lower than the first durometer. The first section includes the first material without the second material, and the third section includes the second material without the first material.