Balloon Catheter Monolithic Distal Member Skive Design
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Solution Overview
Problem
Conventional balloon catheters face challenges in balancing strength and flexibility, often resulting in kinking and failure at the transitions between different material sections, which complicates their use in tortuous anatomy and increases manufacturing costs.
Innovation Solution
A balloon catheter design featuring a monolithic single-layer distal outer member with a skive defined by angled cuts, necked to a reduced diameter, and a hypotube with a skive, providing improved pushability and resistance to kinking, while maintaining flexibility and ease of manufacture.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If conventional balloon catheters use multiple material sections with transitions to balance strength and flexibility, then the catheter can navigate tortuous anatomy, but kinking and failure occur at the transitions between different material sections
Solution Approach 1:
The patent merges the transition zone functionality into the distal outer member itself by creating a monolithic structure with a skive (gradual diameter reduction) along its entire length. This eliminates the need for separate transition sections and bonding interfaces, combining the functions of flexibility, strength, and diameter reduction into a single continuous component made from one material, thereby preventing kinking at transitions while maintaining the ability to navigate tortuous anatomy.
2Ease of operation
If conventional balloon catheters use multiple material sections and bonding to create transition zones, then flexibility and pushability can be balanced, but manufacturing complexity and costs increase
Solution Approach 1:
The invention combines multiple functions (flexibility, pushability, transition zone) into a single monolithic distal outer member with a skive, eliminating the need for multiple material sections and bonding processes. This single-component approach simplifies manufacturing while maintaining the desired balance of flexibility and pushability through the gradual diameter reduction design.
Solution Approach 2:
The patent achieves the balance of flexibility and pushability by changing the geometric parameter of the distal outer member through a skive - a gradual reduction in diameter along its length. This parameter change allows the single component to provide both flexibility (through reduced diameter) and pushability (through maintained wall strength) without requiring multiple materials or complex assembly.
Data Source
Figure 1~9
Figure 2
Figure 3A~3B
AI summary
Balloon catheter (100) includes an outer shaft having a hypotube (220) and a monolithic single-layer distal outer member (230), a balloon (140) in fluid communication with an inflation lumen (200,201,202), and an inner tubular member (240) having a guidewire lumen (210,211) defined therethrough. The outer shaft has the inflation lumen defined therethrough. The monolithic single-layer distal outer member is necked to a reduced diameter along an entire length thereof. A proximal end of the monolithic single-layer distal outer member is coupled to the hypotube. A distal section (222) of the hypotube comprises a skive defined by a first angled cut, an axial cut, and a second angled cut. The balloon has a proximal balloon shaft (145) coupled to a distal end of the monolithic single-layer distal outer member. The inner tubular member extends distally from a proximal port (210) in the monolithic single-layer distal outer member through at least a portion of the balloon.