Integrated Lithotripsy Handle Manifold for Consistent Lesion Fracture
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing intravascular lithotripsy methods face challenges in effectively treating severe vascular lesions like calcified lesions, with a need for enhanced vessel patency and optimized therapy delivery parameters that are easy to control and consistently manufacturable.
Innovation Solution
A catheter system with a handle assembly and source manifold, incorporating a pressure sensor, energy activator, and energy guide, which uses plasma bubble dynamics to generate pressure waves for fracturing vascular lesions, controlled by a system console and GUI.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If intravascular lithotripsy is used to break up vascular lesions, then calcified lesions can be fractured, but the device complexity and manufacturing consistency become challenging
Solution Approach 1:
The source manifold is integrated directly into the handle assembly housing, merging multiple components (manifold, handle, control mechanisms) into a single unified structure. This integration reduces the number of separate parts, simplifies the overall device architecture, and improves manufacturing consistency while maintaining the capability to generate controlled pressure waves for lesion fracture
Solution Approach 2:
The handle assembly is designed to perform multiple functions: it houses the source manifold for pressure wave generation, contains the energy activator for plasma bubble creation, integrates the pressure sensor for real-time monitoring, and provides the energy guide for delivering catheter fluid. This multi-functionality reduces device complexity by eliminating the need for separate dedicated components for each function
2Reliability
If severe vascular lesions are treated with traditional methods, then some lesions can be addressed, but vessel patency optimization and therapy delivery control are insufficient
Solution Approach 1:
A pressure sensor is integrated into the handle assembly to provide real-time feedback on the pressure within the catheter system. This feedback mechanism allows the operator to monitor and adjust therapy delivery parameters dynamically, ensuring optimal vessel patency while maintaining ease of control through immediate information about system state
Solution Approach 2:
The system employs dynamic control of pressure wave generation through the energy activator, which can be selectively triggered to create plasma bubbles at controlled intervals. The pressure sensor provides real-time data that enables dynamic adjustment of therapy parameters, allowing adaptive optimization of vessel patency during the procedure
3Reliability
If plasma bubble dynamics are used to generate pressure waves, then vascular lesions can be fractured, but the manufacturing precision and consistency become difficult to achieve
Solution Approach 1:
By integrating the source manifold directly into the handle assembly housing, the patent creates a unified structure that simplifies manufacturing processes. The integrated design reduces alignment tolerances and assembly variations, improving manufacturing precision and consistency while maintaining the plasma bubble dynamics capability for reliable lesion fracture
Solution Approach 2:
The handle assembly is pre-configured with the source manifold, pressure sensor, and energy activator in fixed, predetermined positions during manufacturing. This preliminary arrangement of components ensures consistent geometric relationships and reduces variability in the plasma bubble generation process, thereby improving manufacturing precision and treatment reliability
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 fractures vascular lesions by generating controlled pressure waves, improving vessel patency and therapy delivery, reducing major adverse events such as myocardial infarction and embolism.
Implementation Method 1
Intravascular lithotripsy utilizes a combination of pressure waves and bubble dynamics that are generated intravascularly in a fluid-filled balloon catheter. In particular, during an intravascular lithotripsy treatment, a high energy source is used to generate plasma and ultimately pressure waves as well as a rapid bubble expansion within a fluid-filled balloon to crack calcification at a treatment site within the vasculature
Implementation Method 2
The rapid change in fluid momentum upon hitting the balloon wall is known as hydraulic shock, or water hammer
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).