Lithotripsy Balloon Catheter With Dual-Direction Emitters for CTO Crossing
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Solution Overview
Problem
Conventional lithotripsy balloon catheters are unable to treat chronic total occlusions (CTOs) due to their inability to cross hardened masses and deliver high-frequency shock waves effectively.
Innovation Solution
A lithotripsy device with both forward-facing and side-facing emitters that generate pressure waves, allowing for both forward and lateral treatment of calcified lesions using a single device, with independent control of emitters for selective treatment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a conventional lithotripsy balloon catheter is used, then the device can deliver high-frequency shock waves to break up calcified lesions, but the device cannot cross hardened masses of CTOs
Solution Approach 1:
The catheter is divided into distinct functional segments: a navigable distal portion for crossing CTOs and a treatment portion with emitters for delivering pressure waves. This segmentation allows the device to first cross the occlusion and then treat it, resolving the contradiction between crossability and treatment capability.
Solution Approach 2:
The invention adds lateral/emission directions to the conventional forward-only shock wave delivery. By positioning emitters on the side of the catheter shaft, the device can deliver pressure waves laterally to treat calcified lesions from multiple directions, enabling treatment of CTOs that were previously inaccessible.
2Reliability
If conventional lithotripsy devices are used, then they can treat calcified lesions, but they cannot treat CTOs because they cannot cross the hardened mass
Solution Approach 1:
The catheter design allows preliminary navigation to the CTO site and crossing of the hardened mass before treatment is initiated. The distal navigable portion enables the device to reach and cross the occlusion first, establishing position for subsequent treatment with the emitter array.
3Adaptability or versatility
If a single emitter configuration is used, then the device structure is simpler, but it cannot deliver pressure waves in both forward and lateral directions
Solution Approach 1:
Different portions of the catheter have different emitter configurations optimized for their specific functions: the distal tip may have forward-facing emitters for initial treatment, while the lateral surface of the shaft has emitters for side-wall treatment. This local differentiation enables multi-directional treatment without requiring complete redesign of the entire device.
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
Enables the treatment of CTOs by softening the proximal end with forward-facing emitters, allowing the catheter to cross the lesion and then treat it from within with side-facing emitters, effectively breaking up calcified lesions.
Implementation Method 1
at least one emitter positioned at the end surface of the tip portion configured to generate pressure waves in the fluid propagating through the balloon to disintegrate a calcified lesion
Data Source
AI summary
A lithotripsy device includes an elongate body comprising a distal tip portion having an end surface that forms a non-zero angle with a longitudinal axis of the elongate body, a balloon circumferentially around a portion of the elongate body enclosing the end surface of the tip portion defining an interior configured to receive a fluid, and at least one emitter positioned at the end surface of the tip portion of the elongate body. The at least one emitter is configured to generate pressure waves in the fluid propagating through the balloon to disintegrate a calcified lesion. A method of using a lithotripsy device is also provided.