Balloon Catheter Distal Neck Inversion for Navigation and Delamination
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Solution Overview
Problem
Cryoablation catheters with long distal tips face challenges in navigating small spaces and are prone to delamination due to pressure exerted by the balloon, making precise tissue contact difficult and increasing the risk of balloon bursting.
Innovation Solution
A balloon catheter design with a shortened distal tip and inverted or everted neck seals that are coterminous with the shaft, reducing the distal length and enhancing resistance to delamination by distributing pressure effectively, allowing for better navigation and sealing.
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 patent inverts the conventional balloon neck configuration by making the distal neck shorter and the proximal neck longer. This inversion allows the balloon to be securely attached to the catheter body without requiring a long distal tip extension, thereby maintaining attachment strength while improving steerability and positioning accuracy within small spaces.
Solution Approach 2:
The patent changes the dimensional parameters of the balloon necks by reducing the distal neck length and increasing the proximal neck length. This parameter modification redistributes the attachment surface area from the distal tip region to the proximal region, achieving both strong attachment and improved device maneuverability.
2Reliability
If longer necks with more attachment surface area are used to prevent delamination, then the resistance to delamination is improved, but the distal length increases making the device more difficult to steer
Solution Approach 1:
The patent applies local quality by concentrating the attachment surface area in the proximal neck region rather than distributing it evenly or extending it distally. This localized concentration of attachment area provides sufficient bonding surface to prevent delamination while keeping the distal tip short for improved steering.
Solution Approach 2:
By inverting the traditional neck length configuration, the patent places the longer neck proximally where additional length provides attachment security without compromising distal steerability, thus resolving the contradiction between delamination resistance and steering ease.
3Reliability
If the balloon pressure is increased to ensure sealing, then the sealing effectiveness is improved, but the tensile stress on the bonding agent increases causing delamination
Solution Approach 1:
The patent uses the balloon pressure itself as a counterweight force by configuring the proximal neck to convert the outward pressure into a compressive force on the bonding agent. This counteracts the tensile stress that would otherwise cause delamination, allowing effective sealing without compromising bond strength.
Solution Approach 2:
The patent modifies the geometric parameters of the proximal neck to optimize the conversion of balloon pressure into compressive force on the bonding agent. By adjusting the neck angle and length, the design ensures that increased balloon pressure enhances sealing while simultaneously increasing compressive rather than tensile stress on the bond.
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 design improves navigation within small spaces, reduces the risk of delamination, and maintains balloon integrity under pressure, facilitating precise tissue contact and effective cryoablation procedures.
Implementation Method 1
The ablation is often performed by passing energy, such as electrical energy, through one or more electrodes causing the tissue in contact with the electrodes to heats up to an ablative temperature
Implementation Method 2
an inflatable element (for example, a balloon) defining a chamber and having a proximal neck coupled to the elongate body and forming a proximal seal, and also having a distal neck coupled to the shaft and forming a distal seal
Data Source
AI summary
A device and system for thermally affecting tissue that includes a balloon catheter with a reduced distal length for ease of navigation and that also includes a balloon that is more resistant to bursting and delamination. The balloon may include a proximal neck generally attached to an elongate body and a distal neck generally attached to a shaft disposed within the elongate body. The distal neck is turned inward to extend within the balloon chamber and the proximal neck may either extend within the chamber or extend proximally away from the balloon chamber. Alternatively, the device may include an inner balloon and an outer balloon, the distal necks of both being turned inward and extending within the inner balloon chamber. The proximal necks may both also be turned inward to extend within the chamber or the proximal neck of the outer balloon may extend away from the balloon chamber.