Shock Wave Catheter Pressure Sensing for Balloon Rupture Control
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Solution Overview
Problem
Existing shock wave catheters face challenges in treating heavily calcified lesions due to non-compliant balloons, inability to monitor energy delivery, potential balloon rupture, and frequent circuit switching, leading to unsatisfactory therapeutic outcomes and safety risks.
Innovation Solution
A shock wave catheter with a pressure-sensitive balloon equipped with sensors and a control system to monitor pressure profiles, allowing for real-time adjustment of energy delivery and electrode connections in parallel or series configurations to prevent damage and extend generator life.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Power
If a non-compliant or semi-compliant balloon is used to deliver radial shock waves, then the shock wave energy can be delivered to calcific masses, but the balloon cannot pass through heavily calcified lesions
Solution Approach 1:
The treatment process is divided into two distinct phases: first, axial shock waves are used to soften the calcified lesion and create a pathway, then the balloon is expanded to deliver radial shock waves. This segmentation of treatment stages allows the balloon to pass through the lesion before delivering the full therapeutic effect.
Solution Approach 2:
Axial shock waves are applied in advance to pre-soften the calcified lesion and create a pathway for the balloon to pass through. This preliminary action removes the barrier that would otherwise prevent balloon advancement, enabling subsequent radial shock wave delivery.
2Adaptability or versatility
If multiple sets of electrodes are connected in series with frequent circuit switching, then the shock wave catheter can treat different lesion locations, but the service life of the switch and generator is shortened
Solution Approach 1:
The catheter is designed with multiple electrode sets that can be connected in parallel to the high-voltage generator, allowing a single generator to treat multiple lesion locations without requiring frequent switching. The multi-functional electrode configuration enables versatile treatment while maintaining generator reliability.
3Power
If high energy is delivered to treat very severely calcified lesions, then the calcific masses can be crushed effectively, but the balloon may rupture due to exceeding maximum energy capacity
Solution Approach 1:
Axial shock waves are applied in advance to pre-soften the calcified lesion, reducing its hardness and density before radial shock wave delivery. This preliminary softening allows the balloon to withstand higher energy levels during radial shock wave treatment without rupturing, while still achieving effective calcific mass crushing.
Solution Approach 2:
The axial shock wave treatment serves as a cushioning preparation that reduces the mechanical strength of the calcified lesion beforehand. This creates a more favorable mechanical environment that protects the balloon from rupture when high-energy radial shock waves are subsequently applied.
4Power
If the balloon is expanded sufficiently against the blood vessel wall to treat asymmetric lesions, then shock wave energy can be delivered to the surface of calcific masses, but the non-compliant balloon cannot be passed through the lesion
Solution Approach 1:
The treatment is segmented into two stages: first, the balloon is advanced in a deflated state through the lesion using axial shock wave assistance, then the balloon is expanded at the target site to deliver radial shock waves to asymmetric lesions. This segmentation allows both successful passage and effective treatment of complex anatomy.
Solution Approach 2:
Axial shock waves are applied preliminarily to create a pathway and soften the lesion before balloon expansion. This preliminary action reduces the mechanical resistance, allowing the balloon to navigate through heavily calcified segments before achieving full expansion for asymmetric lesion treatment.
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 system ensures safe and effective treatment of calcified lesions by preventing balloon rupture and reducing circuit switching, ensuring consistent energy delivery and safer operation.
Implementation Method 1
The balloon is provided thereon with a number of pressure sensors for detecting pressures at different locations on a surface of the balloon
Implementation Method 2
electrodes in the balloon connected to a high-voltage generator can serve as electrohydraulic wave sources, which, when excited, delivers high-voltage pulses for producing shock waves through cavitation
Implementation Method 3
The resulting shock waves propagate through a liquid medium to a wall of the balloon, where they strike and crush calcific masses in the vessel wall
Data Source
AI summary
A shock wave catheter includes a catheter body including inner and outer tubes and a balloon connected to a distal end of the catheter body and provided thereon with a pressure sensor for monitoring a pressure profile within the balloon. The catheter body defines a fluid passage for introducing or discharging a medium into and from the balloon. A shock wave source is disposed on the inner tube to deliver pulses with energy according to the pressure profile. Through monitoring the pressure profile within the balloon during its operation using the pressure sensor disposed on the balloon, in the event of a rupture of the balloon due to some reason, the pressure sensor can quickly identify the abnormality, thereby effectively avoiding possible damage to a human body caused by otherwise continued electric discharge to the human body in the presence of the rupture in the balloon.