US-20260123993-A1 - SYSTEMS AND METHODS FOR MACHINE-LEARNING-BASED OPTIMIZATION OF INTRAVASCULAR LITHOTRIPSY

US20260123993A1US 20260123993 A1US20260123993 A1US 20260123993A1US-20260123993-A1

Abstract

Provided herein are methods and systems for treating a target area of a body lumen using an intravascular lithotripsy catheter, the method comprising: receiving, at a computing system, patient-specific information for a patient that has the at least partially occluded body lumen; determining, by the computing system, at least one parameter of a treatment of the at least partially occluded body lumen with the intravascular lithotripsy catheter, wherein the at least one parameter is determined by processing the patient-specific information with at least one machine learning model; and displaying, by the computing system, guidance for treating the at least partially occluded body lumen with the intravascular lithotripsy catheter based on the at least one parameter, wherein treating the at least partially occluded body lumen with the intravascular lithotripsy catheter comprises the intravascular lithotripsy catheter generating at least one shock wave.

Inventors

Carlos H. Lima
Peter Nabil COSTANDI
Qing He
Hadar Cadouri

Assignees

SHOCKWAVE MEDICAL, INC.

Dates

Publication Date: 20260507
Application Date: 20241107

Claims (20)

1 . A method for treating a target area of a body lumen using an intravascular lithotripsy catheter, the method comprising: receiving, at a computing system, patient-specific information for a patient that has the at least partially occluded body lumen; determining, by the computing system, at least one parameter of a treatment of the at least partially occluded body lumen with the intravascular lithotripsy catheter, wherein the at least one parameter is determined by processing the patient-specific information with at least one machine learning model; and displaying, by the computing system, guidance for treating the at least partially occluded body lumen with the intravascular lithotripsy catheter based on the at least one parameter, wherein treating the at least partially occluded body lumen with the intravascular lithotripsy catheter comprises the intravascular lithotripsy catheter generating at least one shock wave.
2 . The method of claim 1 , wherein the patient-specific information comprises imaging data capturing the at least partially occluded body lumen.
3 . The method of claim 1 , wherein the patient-specific information comprises measurements of the body lumen and/or an occlusion in the body lumen.
4 . The method of claim 1 , wherein the at least one parameter comprises a type of the intravascular lithotripsy catheter or a size of the intravascular lithotripsy catheter.
5 . The method of claim 1 , wherein the at least one parameter comprises at least one parameter for operating the intravascular lithotripsy catheter.
6 . The method of claim 5 , wherein the at least one parameter for operating the intravascular lithotripsy catheter comprises a fluid filling pressure of an enclosure of the intravascular lithotripsy catheter, or at least one parameter of at least one pulse of energy provided to the intravascular lithotripsy catheter for generating shock waves.
7 . The method of claim 6 , wherein the at least one parameter of the at least one pulse of energy comprises a pulse frequency, a pulse amplitude, and a total number of pulses.
8 . The method of claim 6 , wherein the at least one parameter comprises a number of cycles of pulses.
9 . The method of claim 6 , wherein the at least one pulse of energy is at least one electrical pulse or at least one laser pulse.
10 . A system for treating a target area of a body lumen using an intravascular lithotripsy catheter, the system comprising one or more processors and memory storing one or more programs for execution by the one or more processors, the one or more programs including instructions that when executed by the one or more processors cause the system to perform the method of claim 1 .
11 . A method for treating a target area of a body lumen using an intravascular lithotripsy catheter, the method comprising: receiving, at a computing system, data generated during treatment of the at least partially occluded body lumen by the intravascular lithotripsy catheter; determining, by the computing system, at least one parameter for operating the intravascular lithotripsy catheter by processing the data generated during the treatment of the at least partially occluded body lumen with at least one machine learning model; and providing guidance to a treatment provider for operating the intravascular lithotripsy catheter in accordance with the at least one parameter for operating the intravascular lithotripsy catheter.
12 . The method of claim 11 , wherein the data generated during the treatment of the at least partially occluded body lumen by the intravascular lithotripsy catheter comprises imaging data capturing the at least partially occluded body lumen.
13 . The method of claim 11 , wherein the data generated during the treatment of the at least partially occluded body lumen by the intravascular lithotripsy catheter comprises measurements of the body lumen and/or an occlusion in the body lumen.
14 . The method of claim 11 , wherein the at least one parameter comprises at least one parameter for operating the intravascular lithotripsy catheter.
15 . The method of claim 14 , wherein the at least one parameter for operating the intravascular lithotripsy catheter comprises a fluid filling pressure of an enclosure of the intravascular lithotripsy catheter, or at least one parameter of at least one pulse of energy provided to the intravascular lithotripsy catheter for generating shock waves.
16 . The method of claim 15 , wherein the at least one parameter of the at least one pulse of energy comprises a pulse frequency, a pulse amplitude, and a total number of pulses.
17 . The method of claim 16 , wherein the at least one parameter comprises a number of cycles of pulses.
18 . The method of claim 16 , wherein the at least one pulse of energy is at least one electrical pulse or at least one laser pulse.
19 . The method of claim 11 , wherein the at least one parameter for operating the intravascular lithotripsy catheter is determined by processing patient-specific data received by the computing system prior to the treatment.
20 . A system for treating a target area of a body lumen using an intravascular lithotripsy catheter, the system comprising one or more processors and memory storing one or more programs for execution by the one or more processors, the one or more programs including instructions that when executed by the one or more processors cause the system to perform the method of claim 11 .

Description

FIELD OF THE DISCLOSURE The present disclosure relates generally to the field of medical devices and methods, and more specifically to shock wave catheter devices for treating calcified lesions in body lumens, such as calcified lesions and occlusions in vasculature and kidney stones in the urinary system. BACKGROUND A wide variety of catheters have been developed for treating calcified lesions, such as calcified lesions in vasculature associated with arterial disease. For example, treatment systems for percutaneous coronary angioplasty or peripheral angioplasty use angioplasty balloons to dilate a calcified lesion and restore normal blood flow in a vessel. In these types of procedures, a catheter carrying a balloon is advanced into the vasculature along a guide wire until the balloon is aligned with calcified plaques. The balloon is then pressurized (normally to greater than 10 atm), causing the balloon to expand in a vessel to push calcified plaques back into the vessel wall and dilate occluded regions of vasculature. More recently, the technique and treatment of intravascular lithotripsy (IVL) has been developed, which is an interventional procedure to modify calcified plaque in diseased arteries. The mechanism of plaque modification is through use of a catheter having one or more acoustic shock wave-generating sources located within a liquid that can generate acoustic shock waves that modify the calcified plaque. IVL devices vary in design with respect to the energy source used to generate the acoustic shock waves, with two exemplary energy sources being electrohydraulic generation and laser generation. 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. The energy from this electrical discharge enters the surrounding fluid faster than the speed of sound, generating an acoustic shock wave. In addition, the energy creates one or more rapidly expanding and collapsing vapor bubbles that generate secondary shock waves. The shock waves propagate radially outward and modify calcified plaque within the blood vessels. 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 and collapsing vapor bubble, as well as the acoustic shock waves that propagate outward and modify the calcified plaque. The acoustic shock wave intensity is higher if a fluid is chosen that exhibits strong absorption at the laser wavelength that is employed. These examples of IVL devices are not intended to be a comprehensive list of potential energy sources to create IVL shock waves. The IVL process may be considered different from standard atherectomy procedures in that it cracks calcium but does not liberate the cracked calcium from the tissue. Hence, generally speaking, IVL should not require aspiration nor embolic protection. Further, due to the compliance of a normal blood vessel and non-calcified plaque, the shock waves produced by IVL do not modify the normal vessel tissue or non-calcified plaque. Moreover, IVL does not carry the same degree of risk of perforation, dissection, or other damage to vasculature as atherectomy procedures or angioplasty procedures using cutting or scoring balloons. More specifically, catheters to deliver IVL therapy have been developed that include pairs of electrodes for electrohydraulically generating shock waves inside an angioplasty balloon. Shock wave devices can be particularly effective for treating calcified plaque lesions because the acoustic pressure from the shock waves can crack and disrupt lesions near the angioplasty balloon without harming the surrounding tissue. In these devices, the catheter is advanced over a guidewire through a patient's vasculature until it is positioned proximal to and/or aligned with a calcified plaque lesion in a body lumen. The balloon is then inflated with conductive fluid (using a relatively low pressure of 1-4 atm) so that the balloon expands to contact the lesion but is not an inflation pressure that substantively displaces the lesion. Voltage pulses can then be applied across the electrodes of the electrode pairs to produce acoustic shock waves that propagate through the walls of the angioplasty balloon and into the lesions. Once the lesions have been cracked by the acoustic shock waves, the balloon can be expanded further to increase the cross-sectional area of the lumen and improve blood flow through the lumen. Alternative devices to deliver IVL therapy can be within a closed volume other than an angioplasty balloon, such as a cap, balloons of variable compliancy, or other enclo