Catheter Propulsion System for Vascular Lesion Disruption
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Solution Overview
Problem
Current treatments for vascular lesions within blood vessels, such as drug therapy, balloon angioplasty, and stent placement, often require subsequent interventions and may not effectively achieve patency, posing a risk for major adverse events like myocardial infarction and stroke.
Innovation Solution
A catheter system with a propulsion system that advances to a vascular lesion location, featuring a balloon and orifices for fluid jet propulsion, creating an inertial impulse to fracture the lesion by directing a fluid jet at velocities of at least 1 m/s towards the balloon wall, utilizing various propulsion mechanisms including external fluid sources, actuation valves, pistons, and explosive charges.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional treatments (drug therapy, balloon angioplasty, stent placement) are used for vascular lesions, then the treatment can be performed with existing methods, but the treatment may not effectively achieve patency and may require subsequent interventions
Solution Approach 1:
The patent replaces conventional mechanical interventions (balloon angioplasty, stent placement) with a fluid jet propulsion system that uses hydraulic shock to fracture vascular lesions. The propulsion system directs high-velocity fluid jets through orifices in the balloon wall to deliver mechanical energy directly to the lesion, substituting traditional mechanical compression and stenting with fluid-driven mechanical disruption.
Solution Approach 2:
The patent changes the physical parameters of fluid delivery by propelling fluid at high velocities (at least 1 m/s) through controlled orifices. This parameter change in fluid velocity and pressure delivery enables the hydraulic shock mechanism to effectively fracture lesions, achieving patency with a single intervention rather than requiring multiple procedures with conventional methods.
2Reliability
If high velocity fluid jet is used to fracture the lesion, then the momentum transfer effectively disrupts the vascular lesion, but the system complexity increases with propulsion mechanisms
Solution Approach 1:
The balloon serves multiple functions: it provides the structural platform for fluid delivery, acts as the propulsion chamber, and delivers the therapeutic fluid jets through its orifices. This multi-functionality reduces overall system complexity by eliminating the need for separate delivery and treatment components, while still achieving effective lesion disruption through high-velocity fluid jets.
Solution Approach 2:
The propulsion system is self-contained within the catheter assembly, with the fluid propulsion mechanism integrated into the balloon structure. The system uses its own internal fluid pressure and propulsion mechanisms (piston, spring, or explosive charge) to generate the high-velocity jets without requiring external complex machinery, enabling the device to perform both delivery and treatment functions autonomously.
3Reliability
If multiple orifices are used for fluid propulsion, then the momentum transfer to the lesion is enhanced, but the manufacturing complexity of the catheter increases
Solution Approach 1:
The fluid delivery system is segmented into multiple discrete orifices distributed across the balloon surface. This segmentation allows the fluid jet propulsion to target different portions of the lesion simultaneously, enhancing momentum transfer efficiency. The segmented orifice design can be fabricated using standard medical device manufacturing techniques such as laser drilling or injection molding, balancing improved performance with manufacturability.
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 disrupts vascular lesions by transferring momentum through hydraulic shock, reducing the risk of adverse events and potentially eliminating the need for subsequent treatments by directly fracturing and disrupting the lesions.
Implementation Method 1
propel a fluid from the orifice toward the balloon wall to create an inertial impulse in a vessel wall to transfer momentum to the vascular lesion
Implementation Method 2
create an inertial impulse in a vessel wall to transfer momentum to the vascular lesion
Implementation Method 3
disrupts vascular lesions by transferring momentum through hydraulic shock
Data Source
AI summary
Embodiments herein relate to systems and methods for intravascular lesion disruption. In an embodiment, a catheter system for imparting pressure to induce fractures upon a vascular lesion within or adjacent a blood vessel wall is included. The system includes a catheter configured to advance to a vascular lesion, the catheter including an elongate shaft that defines at least a first orifice for fluid flow; a balloon, coupled to the elongate shaft, that surrounds the first orifice where the balloon can expand from a collapsed configuration suitable for advancing the catheter through a patient's vasculature to a first expanded configuration suitable for anchoring the catheter in position relative to a treatment site; and a propulsion system configured to propel a fluid from the first orifice toward the balloon wall to create an inertial impulse in a vessel wall to transfer momentum to the vascular lesion. Other embodiments are also included herein.