Manifold Integrated Handle for Intravascular Lithotripsy
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Solution Overview
Problem
Current treatments for vascular lesions, such as intravascular lithotripsy, face challenges in consistently achieving vessel patency and optimizing therapy delivery parameters, making it difficult to effectively treat severe calcified or fibrous lesions within blood vessels.
Innovation Solution
A catheter system with a handle assembly, source manifold, and inflatable balloon that uses pressure waves generated by an energy guide, such as optical fibers or high voltage electrodes, to create plasma and impart fracture forces on vascular lesions, incorporating a pressure sensor and energy activator for controlled treatment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If intravascular lithotripsy is used to break up calcified vascular lesions, then vessel patency can be improved, but the device complexity and difficulty of controlling therapy delivery parameters increase
Solution Approach 1:
The source manifold is integrated directly into the handle assembly housing, merging the fluid delivery system with the handle structure. This integration reduces the number of separate components and simplifies the overall device architecture while maintaining the ability to deliver pressure waves for intravascular lithotripsy treatment
Solution Approach 2:
The handle assembly is designed to accommodate multiple catheter configurations and therapy delivery parameters through a single integrated platform. The source manifold can work with different catheter types and the handle assembly can control various therapy parameters, making the device versatile without requiring multiple separate systems
2Reliability
If intravascular lithotripsy is used to treat severe calcified vascular lesions, then treatment efficacy can be improved, but the difficulty of consistently achieving optimal therapy delivery increases
Solution Approach 1:
The system incorporates a pressure sensor that provides feedback on the pressure within the catheter system. This feedback mechanism allows the operator to monitor therapy delivery parameters in real-time and make adjustments to achieve optimal treatment outcomes consistently, rather than relying on fixed or estimated parameters
3Ease of operation
If a separate source manifold is used outside the handle assembly, then accessibility for connection may be improved, but the device complexity and manufacturing difficulty increase
Solution Approach 1:
The source manifold is integrated directly into the handle assembly housing, merging what would otherwise be separate components. This integration simplifies manufacturing by reducing the number of separate parts that need to be produced and assembled, while ensuring consistent assembly through a unified structure that is easier to manufacture as a single unit
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 effectively induces fractures in vascular lesions by transferring mechanical energy through the catheter fluid, improving vessel patency and treatment efficacy while being easy to control and manufacture.
Implementation Method 1
a high energy source is used to generate plasma and ultimately pressure waves
Implementation Method 2
high voltage electrodes
Implementation Method 3
rapid bubble expansion within a fluid-filled balloon
Implementation Method 4
The rapid change in fluid momentum upon hitting the balloon wall is known as hydraulic shock, or water hammer
Implementation Method 5
a pressure sensor and energy activator for controlled treatment
Data Source
AI summary
A catheter system (100) for treating a vascular lesion (106A) within or adjacent to a vessel wall (108A) of a blood vessel (108) within a body (107) of a patient (109) includes a catheter shaft (210); a handle assembly (228); and a source manifold (236). The handle assembly (228) is coupled to the catheter shaft (210). The handle assembly (228) includes an assembly housing (266). The handle assembly (228) is usable by a user to selectively position the catheter shaft (210) near the vascular lesion (106A). The source manifold (236) is coupled to the assembly housing (266). The source manifold (236) includes a manifold housing (282) having a catheter shaft port (264) that is configured to receive a portion of the catheter shaft (210) so that the catheter shaft (210) is coupled to the manifold housing (282).


