Balloon Pressure-Wave Emitters for Calcified Lesion Fragmentation
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Solution Overview
Problem
Existing intravascular lithotripsy procedures face challenges in effectively fragmenting and disintegrating calcified lesions within a patient's vasculature using high-energy pressure waves, particularly due to the limitations of current energy delivery systems and catheter designs.
Innovation Solution
A catheter system with an array of pressure-wave emitters distributed within an interventional balloon, which generates and directs high-energy pressure waves through a fluid-filled balloon to fragment calcified lesions, utilizing an electronic emitter configuration with spark gaps and independent actuation capabilities, and includes sensors for energy control based on sensor data.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single pressure-wave emitter is used in the balloon, then the device complexity is reduced, but the treatment efficacy and energy distribution uniformity deteriorate
Solution Approach 1:
The pressure-wave emission system is divided into multiple independent emitters distributed around the balloon circumference. Each emitter can be independently controlled to generate pressure waves, allowing targeted treatment of different lesion locations and improved energy distribution uniformity throughout the vasculature.
Solution Approach 2:
Multiple pressure-wave emitters are integrated into a single balloon catheter system, combining their functions to achieve comprehensive lesion coverage. The emitters work together to deliver energy uniformly across the entire treatment site, improving overall treatment efficacy while maintaining a unified device structure.
2Reliability
If real-time sensor monitoring and energy adjustment are implemented, then treatment safety and precision are improved, but the device complexity and control system requirements increase
Solution Approach 1:
Sensors are integrated into the balloon to detect pressure, temperature, or other treatment parameters in real-time. This feedback is transmitted to the control system, which automatically adjusts the energy delivery of the pressure-wave emitters to maintain optimal treatment conditions and prevent adverse events, thereby improving treatment safety and precision.
3Power
If multiple electrodes with spark gaps are used, then the pressure wave generation capability is improved, but the manufacturing precision and assembly difficulty increase
Solution Approach 1:
The electrodes are designed with asymmetric spark gap configurations optimized for specific pressure wave generation requirements. This asymmetric design allows for controlled energy delivery while simplifying the manufacturing process by reducing the need for precise symmetric alignment of multiple electrode components.
Data Source
AI summary
A medical device may include an elongated body, a balloon positioned at a distal portion of the elongated body, and one or more pressure-wave emitters positioned along a central longitudinal axis of the elongated body within the balloon. The one or more pressure-wave emitters may be configured to propagate pressure waves radially outward through the fluid to fragment a calcified lesion at the target treatment site. The at least one of the one or more pressure-wave emitters may comprise an electronic emitter including a first electrode and a second electrode. The first electrode and the second electrode may be arranged to define a spark gap between the first electrode and the second electrode, and the second electrode may comprise a portion of a hypotube.