Inverted Distal Neck Balloon for Cryoablation Steering
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Solution Overview
Problem
Current cryoablation catheters face challenges in navigating small spaces due to long distal tips, are prone to delamination, and experience warming issues from blood flow, which complicates precise tissue contact and effective ablation procedures.
Innovation Solution
A medical device with a shortened distal tip and a balloon configuration where the distal neck inverts within the balloon chamber, reducing delamination risk and enhancing cooling efficiency by minimizing contact with warm blood.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If the distal tip is extended beyond the balloon to provide adequate attachment strength, then the balloon attachment strength is improved, but the device becomes more difficult to position and steer within small spaces
Solution Approach 1:
The distal tip is retracted within the balloon chamber, nesting the tip inside the balloon structure. This eliminates the protruding distal tip while maintaining attachment strength through the inverted distal neck configuration that secures the balloon to the catheter body without requiring an extended tip.
Solution Approach 2:
The distal neck of the balloon is inverted within the balloon chamber, turning the attachment mechanism inside out. This inversion allows the distal tip to be retracted within the balloon while maintaining secure attachment, resolving the contradiction between attachment strength and steering ease.
2Reliability
If longer necks with more attachment surface area are used to prevent delamination, then the seal reliability is improved, but the balloon length increases making it more difficult to steer
Solution Approach 1:
The distal neck is inverted and nested within the balloon chamber, creating a compact configuration. This nesting provides sufficient attachment surface area through the inverted neck structure while keeping the overall balloon length short, thereby maintaining seal reliability without compromising steering ease.
Solution Approach 2:
The attachment surface is reconfigured from a longitudinal extension (longer necks) to a radial/inverted configuration within the balloon chamber. This dimensional change provides adequate attachment area without increasing the longitudinal length of the balloon, resolving the contradiction between seal reliability and steering ease.
3Temperature
If the balloon is cooled to ablation temperatures, then the ablation effectiveness is improved, but the warm blood flow causes warming of the treatment element increasing coolant demand
Solution Approach 1:
The inverted distal neck configuration preliminarily reduces the surface area exposed to warm blood flow before the cooling process begins. By minimizing the contact between the balloon and warm blood through the inverted neck design, the preliminary anti-action reduces the warming effect and subsequent coolant demand while maintaining effective ablation temperatures.
4Ease of operation
If the distal tip is shortened to improve steering, then the ease of operation is improved, but the attachment strength between balloon and catheter may be compromised
Solution Approach 1:
The distal neck is inverted within the balloon chamber, fundamentally changing the attachment geometry. This inversion allows the distal tip to be shortened or retracted while the inverted neck provides sufficient attachment surface area and mechanical strength to secure the balloon to the catheter body, resolving the contradiction between steering ease and attachment strength.
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 device allows for more precise navigation and effective tissue contact, reducing the risk of delamination and warming effects, thereby improving the accuracy and efficiency of cryoablation procedures.
Implementation Method 1
a cryoballoon is cooled to a temperature sufficient to ablate tissue by the expansion and circulation of a coolant or cryogenic fluid within the cryoballoon
Implementation Method 2
the circulation of warm blood around the cryoballoon may increase the temperature of the cryoballoon
Implementation Method 3
Ablation procedures may also involve the modification of the tissue without removal, such as to stop electrical propagation through the tissue in patients with an arrhythmia
Implementation Method 4
it may also be performed by freezing the tissue with the use of a cryoablation catheter
Data Source
Figure 1A
Figure 1B~2
Figure 3~4
AI summary
A device, method, and system for thermally affecting tissue. The device may generally include an elongate body, an actuation element slidably disposed within the elongate body, a balloon defining an interior chamber, a proximal neck, and a distal neck, the first neck being coupled to the distal portion of the elongate body and the second neck being coupled to the distal portion of the actuation element, retraction of the actuation element within the elongate body causing the treatment element to transition from a first configuration to a second configuration. The distal neck may be located external to the interior chamber in the first configuration and within the interior chamber in the second configuration. The device may also include a fluid injection element that is transitionable to an expanded configuration when the balloon is inflated, thereby enhancing the cooling capacity of the balloon.