Helical Balloon Catheter Support for Rapid Deflation
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Solution Overview
Problem
Current single lumen balloon catheters face issues with inadequate seal between the balloon distal tip and guidewire, leading to poor balloon visibility and potential clot formation, which can result in vessel damage and complications during procedures due to inadequate rapid deflation capabilities.
Innovation Solution
A tubular support member for balloon catheters is designed with a plurality of annular segments and beams that form a helix structure, allowing for isotropic bending and rapid deflation, along with a polymer jacket and balloon configuration that fluidly seals slots for improved inflation and deflation times, tensile strength, kink resistance, tracking, and stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional single lumen balloon catheter with punched or laser drilled ports is used, then the structure is simple and easy to manufacture, but the seal between the balloon distal tip and guidewire is inadequate leading to poor balloon visibility and clot formation
Solution Approach 1:
The catheter shaft is divided into multiple segments (first shaft segment, second shaft segment, third shaft segment) with different functions. The first segment contains inflation/deflation ports, the second segment contains slots for rapid deflation, and the third segment is a flexible distal tip. This segmentation allows each segment to be optimized for its specific function while working together to solve the sealing problem.
Solution Approach 2:
A polymer jacket is introduced as an intermediary component that extends over the support member and fluidly seals the slots. This polymer jacket acts as a mediator between the guidewire seal and the slots, preventing blood from entering through the slots while maintaining the rapid deflation capability. The polymer jacket specifically addresses the inadequate seal problem by creating a fluid barrier.
2Productivity
If inflation/deflation ports are punched or laser drilled in the polymeric shaft, then manufacturing is simplified, but rapid deflation capability is compromised due to inadequate seal and clot formation
Solution Approach 1:
The catheter is segmented into functional zones: the first shaft segment with traditional punched/laser drilled inflation/deflation ports for normal operation, and the second shaft segment with slots covered by a polymer jacket for rapid deflation. This segmentation allows the system to provide both rapid deflation capability through the slots and reliable sealing through the polymer jacket, while maintaining compatibility with simplified manufacturing methods for the ports.
Solution Approach 2:
The polymer jacket serves as an intermediary that enables the slots to function as effective deflation pathways. By fluidly sealing the slots, the polymer jacket prevents blood from entering and forming clots, thereby enabling rapid deflation without compromising reliability. This intermediary component transforms the slots from potential sources of clot formation into reliable rapid deflation channels.
3Strength
If the balloon catheter uses a traditional support structure, then manufacturing is easier, but the catheter lacks resistance to bowing/buckling and isotropic bending capability
Solution Approach 1:
The support member is designed with a dynamic helical structure consisting of multiple windings of wire or rod material. This helical configuration provides isotropic bending capability, allowing the catheter to bend equally well in any direction without kinking or buckling. The dynamic nature of the helix allows it to flex and adapt to various routing requirements while maintaining structural integrity and resistance to bowing/buckling.
Solution Approach 2:
The support member is constructed as a composite structure combining the helical wire/rod framework with the polymeric shaft segments and polymer jacket. This composite construction provides both the mechanical strength needed for kink resistance and the flexibility required for isotropic bending. The combination of rigid helical support and flexible polymeric materials creates a structure that is both strong and manufacturable.
Data Source
Figure 1~2C
Figure 3A~3B
Figure 4
AI summary
A tubular catheter support member (26) comprises a plurality of annular segments (32) stacked along a longitudinal axis of the catheter, and a plurality of beams (34) connecting respective annular segments in the stack, wherein the beams meet the respective annular segments at oblique angles, and wherein the beams collectively form a helix around the longitudinal axis of the catheter.