Radial Balloon Catheter Hypotube Openings for Priming Flow
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Solution Overview
Problem
Balloon catheters face challenges with fluid stagnation and trapped air during inflation and deflation due to the 'floating' hypotube design, which complicates priming and evacuation procedures, especially in radial access catheters used for vascular procedures.
Innovation Solution
Incorporation of flow openings in the hypotube wall at specific zones to facilitate fluid movement and reduce stagnation, allowing for efficient inflation, deflation, and priming of the balloon.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If the catheter is made longer to reach from radial access site to distant treatment locations, then the ability to reach distant stenosed regions is improved, but the flexibility and navigation capability through tight bends deteriorates
Solution Approach 1:
The catheter shaft is divided into multiple segments with different stiffness characteristics. The proximal portion has higher stiffness for pushability, while the distal portion has lower stiffness for flexibility. This segmentation allows the long catheter to navigate tortuous anatomy effectively despite its extended length.
Solution Approach 2:
Different regions of the catheter shaft are assigned different mechanical properties. The proximal region is designed with higher stiffness to facilitate pushing through the vasculature, while the distal region is designed with lower stiffness to navigate tight bends and tortuous anatomy. This local differentiation resolves the contradiction between length and navigation capability.
2Ease of operation
If the catheter shaft is made stiffer to improve pushability and navigation, then the ease of navigation is improved, but the ability to navigate tight bends deteriorates
Solution Approach 1:
The catheter shaft is segmented into proximal and distal portions with different stiffness levels. The proximal segment provides the necessary stiffness for pushability, while the distal segment provides the flexibility needed for navigating tight bends, thus resolving the contradiction between ease of operation and adaptability.
Solution Approach 2:
The catheter employs local quality by assigning different mechanical properties to different regions. The proximal portion has higher stiffness for pushability, while the distal portion has lower stiffness for flexibility, allowing the catheter to simultaneously achieve ease of operation and adaptability to tortuous anatomy.
3Stability of the object's composition
If the hypotube is fixed along its entire length to the outer shaft, then the structural stability is improved, but the flexibility to navigate tight bends deteriorates
Solution Approach 1:
The hypotube attachment is segmented into discrete bond sites rather than continuous fixation. The hypotube is bonded to the outer shaft at specific locations (proximal and distal bond sites) but remains unbonded in between, creating floating segments that provide flexibility while maintaining structural stability through the bonded regions.
Solution Approach 2:
The hypotube attachment transitions from a static continuous bond to a dynamic configuration with floating segments. These floating segments can move relative to the outer shaft, allowing the catheter to adapt its shape for navigating tight bends while the bonded regions provide structural stability.
4Adaptability or versatility
If the hypotube is detached from the outer shaft to increase flexibility, then the flexibility for navigation is improved, but the structural stability and pushability deteriorates
Solution Approach 1:
The hypotube attachment is segmented into discrete bond sites rather than continuous fixation. The hypotube is bonded to the outer shaft at specific locations (proximal and distal bond sites) but remains unbonded in between, creating floating segments that provide flexibility while maintaining structural stability through the bonded regions.
Solution Approach 2:
The catheter employs local quality by assigning different attachment characteristics to different regions. The proximal and distal regions have bonded hypotube for structural stability, while the intermediate regions have floating hypotube for flexibility, allowing the catheter to simultaneously achieve both stability and adaptability.
5Reliability
If the hypotube is continuously bonded to the outer shaft, then the structural integrity is improved, but fluid stagnation and air trapping increase
Solution Approach 1:
The continuous bond between hypotube and outer shaft is segmented into discrete bond sites. This segmentation creates floating segments that allow fluid to move freely between the hypotube lumen and the space between the hypotube and outer shaft, preventing stagnation and air trapping while maintaining structural integrity through the bonded regions.
Solution Approach 2:
The continuous bond is extracted and replaced with discrete bond sites. This removal of the continuous constraint allows fluid to access the previously sealed space between the hypotube and outer shaft, eliminating stagnation zones and air pockets while preserving structural integrity where needed.
6Reliability
If multiple priming and evacuation procedures are performed to eliminate trapped air and fluid, then the completeness of fluid delivery is improved, but the time and labor required increases
Solution Approach 1:
The continuous bond between hypotube and outer shaft is extracted and replaced with discrete bond sites. This removal of the continuous constraint allows fluid to access the previously sealed space between the hypotube and outer shaft, eliminating stagnation zones and air pockets while preserving structural integrity where needed.
Solution Approach 2:
The catheter design incorporates floating segments and flow openings that prevent air and fluid stagnation before the priming process begins. This preliminary design feature eliminates the need for repeated priming and evacuation procedures, saving time and labor while ensuring complete fluid delivery.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The flow openings enhance fluid flow through the catheter assembly, minimizing bubble formation and reducing the need for repeated priming and evacuation procedures, thereby improving operational efficiency and reducing procedural time.
Implementation Method 1
The floating construction allows the outer shaft to deflect further than the stiffer hypotube thereby allowing a higher effective bend radius for the catheter shaft
Implementation Method 2
The inflation fluid, such as a liquid, is pushed distally along the lumen of the hypotube toward the balloon to initiate inflation. The fluid is moved proximally along the catheter assembly, such as along the hypotube lumen, to deflate the balloon
Data Source
AI summary
Discussed herein are various embodiments related to a catheter assembly. The catheter assembly can include a catheter body extending between a proximal portion and a distal portion. The catheter body can include a sleeve and a hypotube, connected by at least one bond site, and separated by a floating gap. The hypotube can include at least one flow opening extending from the hypotube lumen to a stagnation zone, configured to permit flow between the stagnation zone and the hypotube lumen.