Stepped Lead Wire Balloon Catheter for Tortuous Arteries
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Solution Overview
Problem
Conventional balloon catheters are inadequate for effectively accessing and dilating lower extremity arteries due to their lack of flexibility and inappropriate size for navigating tortuous and thinner arteries, which is a challenge in treating Critical Limb Ischemia.
Innovation Solution
A balloon dilatation medical device with a stepped lead wire that allows for a low-profile, flexible design, enabling navigation through lower extremity arteries, featuring a catheter shaft with a balloon mounted on the lead wire, where the balloon is axially fixed to the lead wire, providing a smooth transition and support while reducing to a smaller diameter than the catheter shaft.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a conventional balloon catheter is used, then the catheter can be manufactured with standard design, but it cannot effectively navigate through tortuous and thinner lower extremity arteries
Solution Approach 1:
The catheter is divided into multiple sections with varying flexibility characteristics. The distal portion contains the balloon and is designed to be more flexible, while the proximal portion provides structural support. This segmentation allows the catheter to navigate tortuous lower extremity arteries while maintaining operational control.
Solution Approach 2:
Different portions of the catheter have different structural properties tailored to their specific functions. The distal section has a smaller profile and higher flexibility for navigating narrow, tortuous arteries, while the proximal section has a larger profile and higher rigidity for operator control and force transmission.
2Ease of operation
If the catheter is made flexible to navigate tortuous arteries, then navigation capability improves, but the catheter becomes too large and cannot effectively access thinner arteries
Solution Approach 1:
The catheter employs a dynamic structure where the flexibility and profile can adapt to different physiological conditions. The material composition and structural design allow the catheter to be flexible enough for navigation while maintaining an appropriately sized profile for the specific artery being treated.
Solution Approach 2:
The catheter design incorporates parameter changes along its length, with the distal portion having smaller dimensions and higher flexibility, while the proximal portion has larger dimensions and higher rigidity. This gradient approach allows the catheter to navigate tortuous pathways while maintaining an appropriate profile for thinner arteries.
3Strength
If the balloon is mounted on the catheter shaft, then structural support is provided, but the device cannot reduce to a smaller diameter for low-profile navigation
Solution Approach 1:
The balloon is nested within the catheter shaft in a collapsed state during navigation, allowing the device to maintain a small profile. When inflated at the target site, the balloon expands to provide the necessary structural support and dilation function, effectively nesting the support structure within the navigation profile.
Data Source
AI summary
A medical device includes a catheter shaft extending along a longitudinal axis and having a shaft lumen. A balloon includes a proximal balloon end coupled to the catheter shaft, an interior in fluid communication with the shaft lumen, and a distal balloon end. A lead wire extends from a proximal wire end through the shaft lumen and the interior to a distal wire end. The lead wire includes a stepped portion between a proximal wire surface and a distal wire surface. The distal balloon end is axially fixed to the proximal wire surface. The proximal wire surface is narrower than the distal wire surface. Other embodiments are described and claimed.