Segmented Balloon Catheter for Intravascular Lithotripsy
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Solution Overview
Problem
Existing intravascular lithotripsy (IVL) devices face challenges such as trauma during translation, complexity in construction, variable pressure outputs, and limited durability and efficiency, leading to unpredictable outcomes and balloon instability.
Innovation Solution
The development of an IVL system with a reduced crossing profile, a more flexible tip, and a kink-resistant shaft, featuring a controlled spark gap distance and adjustable energy delivery to maintain consistent pressure outputs, and capable of producing up to 500 voltage pulses per catheter.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If existing IVL devices are used, then calcified lesions can be treated, but trauma during translation and balloon instability occur
Solution Approach 1:
The catheter shaft incorporates a kink-resistant construction with dynamic flexibility, allowing the shaft to bend and conform to vascular anatomy without permanent deformation or trauma during translation. The flexible tip section enables adaptive navigation through tortuous vessels while maintaining structural integrity.
Solution Approach 2:
The balloon element utilizes a flexible membrane structure that can inflate and deflate repeatedly without degradation. The thin film construction allows the balloon to conform to vessel walls during inflation while preventing trauma during catheter manipulation and translation.
2Reliability
If existing IVL devices are used, then electrical arcs can be generated, but pressure output variability and limited durability occur
Solution Approach 1:
The voltage pulse generator incorporates feedback control mechanisms that monitor and adjust electrical pulse parameters in real-time. This feedback system maintains consistent pressure outputs across multiple pulses by compensating for variations in electrode spacing, fluid composition, and balloon inflation state, enabling durable operation with up to 500 voltage pulses per catheter.
Solution Approach 2:
The system dynamically adjusts electrical parameters including voltage magnitude, pulse duration, and frequency to optimize pressure wave generation. By changing these parameters based on real-time conditions, the system maintains consistent therapeutic effects while extending catheter durability through controlled energy delivery.
3Ease of operation
If existing IVL devices are used, then treatment can be performed, but device complexity and unpredictable outcomes occur
Solution Approach 1:
The catheter integrates multiple functions into a single device including high-voltage electrical pulse delivery, balloon inflation/deflation, and pressure wave generation. This multi-functional design simplifies the overall system by combining electrode arrays, fluid delivery, and energy delivery capabilities in one integrated catheter structure, reducing procedural complexity while improving predictability.
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 improved IVL system achieves tighter control over pressure outputs, increased durability, and enhanced efficiency, allowing for more predictable and effective treatment with reduced trauma and complexity.
Implementation Method 1
A voltage pulse generator is provided in operative connection with pairs of spaced-apart electrodes disposed within an inflatable enclosure and configured to deliver high voltage electrical pulses to one another to create electrical arcs
Implementation Method 2
Transform Electrical Energy to Mechanical Energy
Implementation Method 3
an inflatable enclosure, such as a balloon, positioned at or near a distal end of the catheter structure and configured to receive fluid for inflation to facilitate IVL therapy
Data Source
AI summary
A catheter and segmented balloon system for an intravascular lithotripsy system having improved accommodation for curved configurations to prevent damage to the balloon during electrical arcing of electrode pairs. The catheter can include an elongate member with alternating flexibility regions wherein stiffer regions are configured to support at least one spaced-apart electrode pair, and wherein more flexible regions are disposed on either side of each stiffer region. This configuration allows the elongate member to curve more easily in the region of the electrodes, which are located within a balloon, or segmented balloon system. The balloon can include balloon segments with interposed sections between each of the segmented balloons wherein the outer diameter of an inflated balloon segment is larger than the outer diameter of the interposed section.