Shock Wave Catheter With Retractable Enclosure for Mixed Tissue Treatment
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Solution Overview
Problem
Existing IVL catheters are limited in their ability to effectively treat tissue types other than calcified lesions, such as fibrotic or thrombotic masses, and may not be suitable for lesions with multiple tissue types, as they often require an angioplasty balloon or similar enclosure.
Innovation Solution
A retractable enclosure shock wave catheter design that allows the shock wave emitter assembly to be enclosed or exposed, with perfusion capabilities for fluid circulation, enabling adjustable sonic output and configuration for various tissue types.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If an angioplasty balloon or similar enclosure is used to deliver shock waves, then the shock wave emitter is protected and contained, but the device cannot effectively treat tissue types other than calcified lesions and lacks flexibility for diverse tissue types
Solution Approach 1:
The patent applies the dynamics principle by making the enclosure retractable rather than fixed. The enclosure can be extended to enclose the shock wave emitter assembly during delivery and retracted during treatment, allowing the device to adapt between different operational states. This dynamic configuration enables treatment of diverse tissue types including fibrotic or thrombotic masses while maintaining manageable device complexity through a single movable component rather than multiple fixed structures
Solution Approach 2:
The patent implements universality by designing a shock wave catheter that can treat multiple tissue types (calcified lesions, fibrotic masses, thrombotic masses) using the same device platform. The retractable enclosure combined with adjustable shock wave emitter assembly creates a universal treatment system that adapts to different tissue characteristics without requiring separate specialized devices for each tissue type
2Power
If the shock wave emitter assembly is exposed to the vasculature, then higher sonic output can be achieved for treating diverse tissue types, but surrounding tissue may be damaged
Solution Approach 1:
The patent applies preliminary action by extending the enclosure before delivering high-power shock waves. The enclosure is positioned and secured in place prior to shock wave emission, creating a protective barrier that will contain the high sonic output. This preliminary protective action allows the system to deliver the necessary high power for treating diverse tissue types while preventing damage to surrounding healthy tissue through pre-established containment
Solution Approach 2:
The retractable enclosure serves as an intermediary between the shock wave emitter assembly and the surrounding vasculature. When extended, it mediates the interaction by containing the high sonic output within a controlled environment, allowing high power treatment while protecting surrounding tissues. The enclosure acts as a buffer that enables high power delivery without direct exposure of the emitter to vulnerable surrounding structures
3Adaptability or versatility
If a retractable enclosure is used to enable flexibility for various tissue types, then adaptability is improved, but the device structure becomes more complex
Solution Approach 1:
The patent resolves this contradiction by implementing a single-degree-of-freedom retractable mechanism that provides configuration flexibility through one primary motion (extension/retraction). This dynamic design achieves adaptability for various tissue types without requiring multiple complex mechanisms, maintaining relatively simple device structure while enabling the enclosure to transition between enclosed and exposed states as needed for different treatment scenarios
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 retractable enclosure design enhances treatment efficacy by allowing higher sonic output and flexibility in treating diverse tissue types, including fibrotic or thrombotic masses, while minimizing damage to surrounding tissue.
Implementation Method 1
For electrohydraulic generation of acoustic shock waves, a conductive solution (e.g., saline) may be contained within an enclosure that surrounds electrodes or can be flushed through a tube that surrounds the electrodes. The calcified plaque modification is achieved by creating acoustic shock waves within the catheter by an electrical discharge across the electrodes. This discharge creates one or more rapidly expanding vapor bubbles that generate the acoustic shock waves.
Implementation Method 2
For laser generation of acoustic shock waves, a laser pulse is transmitted into and absorbed by a fluid within the catheter. This absorption process rapidly heats and vaporizes the fluid, thereby generating the rapidly expanding vapor bubble, as well as the acoustic shock waves that propagate outward and modify the calcified plaque.
Implementation Method 3
These shock waves propagate radially outward and modify calcified plaque within the blood vessels. The acoustic pressure from the shock waves can crack and disrupt lesions near the angioplasty balloon without harming the surrounding tissue.
Data Source
AI summary
A shock wave catheter for treating a lesion in a body lumen includes a shock wave emitter assembly and a retractable enclosure. In a first configuration of the catheter, the retractable enclosure is sealed to a distal member of the catheter and the lesion is treated by shock waves propagating through the enclosure wall. In a second configuration of the catheter, the retractable enclosure is retracted from the distal member of the catheter and the lesion is treated directly by shock waves emitted from the shock wave emitter assembly.