US-12616490-B2 - Systems, devices, and methods for treatment of target material in a body lumen with shock waves

US12616490B2US 12616490 B2US12616490 B2US 12616490B2US-12616490-B2

Abstract

A catheter includes a catheter body; at least one shock wave emitter disposed on the catheter body; and a moveable shield extending at least partially around the catheter body and configured for translating along the catheter body. Exemplary catheters are configured to modify lesions, including fibrotic and calcified tissue buildup within the body.

Inventors

Rainier Betelia
Thomas Charles Hasenberg
Daryl Wong
Thu Anh Ho
Robert Zelenka

Assignees

SHOCKWAVE MEDICAL, INC.

Dates

Publication Date: 20260505
Application Date: 20241126

Claims (20)

1 . A catheter comprising: a catheter body; at least one shock wave emitter disposed on the catheter body; and a moveable shield extending at least partially around the catheter body and configured for translating along the catheter body.
2 . The catheter of claim 1 , wherein the shield is positionable so that the shield covers the at least one shock wave emitter.
3 . The catheter of claim 2 , wherein the shield is positionable so that a distal end of the shield does not cover the at least one shock wave emitter.
4 . The catheter of claim 1 , wherein the catheter body further comprises a central lumen configured to receive at least one of a guidewire and a pacemaker lead.
5 . The catheter of claim 1 , wherein the shield comprises a tapered distal end.
6 . The catheter of claim 5 , wherein the at least one shock wave emitter comprises a plurality of shock wave emitters, and wherein the shield is positionable with respect to the catheter body such that the tapered distal end of the shield covers at least one but not all of the plurality of shock wave emitters.
7 . The catheter of claim 5 , wherein the tapered distal end is configured to be extended distally of the distal end of the catheter body for piercing tissue.
8 . The catheter of claim 1 , comprising at least one forward firing shock wave emitter positioned at the distal end of the catheter body distally of the at least one shock wave emitter and configured to generate at least one forward propagating shock wave.
9 . The catheter of claim 1 , wherein the at least one shock wave emitter comprises a radially firing shock wave emitter.
10 . A catheter for use in a body lumen, the catheter comprising: a catheter body comprising a central lumen; at least one shock wave emitter disposed at a distal portion of the catheter body and configured to generate at least one shock wave that propagates distally of the catheter body; and a cutter configured to be translated relative to the catheter body to an extended position in which a distal end of the cutter is distal of a distal end of the catheter body for cutting tissue located distally of the distal end of the catheter body.
11 . The catheter of claim 10 , wherein the cutter is configured to be retracted so that a distal end of the cutter is proximal of the distal end of the catheter body.
12 . The catheter of claim 10 , wherein the cutter comprises a tube having a distal end configured for cutting the tissue.
13 . The catheter of claim 12 , wherein the distal end of the tube comprises at least one of a beveled end, a serrated end, a scalloped end, and a double beveled end.
14 . The catheter of claim 12 , wherein the tube is configured to extend up to 10 millimeters beyond a distal most surface of the catheter body.
15 . The catheter of claim 14 , wherein the catheter body comprises a nozzle and a distal end of the nozzle comprises the distal-most surface of the catheter body.
16 . The catheter of claim 15 , wherein the nozzle is configured to concentrate the at least one shock wave generated by the at least one shock wave emitter at the outlet of the nozzle.
17 . The catheter of claim 10 , wherein the cutter comprises a lumen configured to receive a pacemaker lead.
18 . The catheter of claim 10 , wherein the cutter is operatively connected to a user-engageable sliding component configured to enable a user to translate the cutter relative to the catheter body.
19 . The catheter of claim 10 , wherein the cutter is biased toward a retracted position.
20 . The catheter of claim 10 , wherein the cutter is rotatable relative to the catheter body, and the rotatable cutter is operatively connected to a user-engageable rotational component to enable a user to rotate the cutter.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application claims priority benefit of U.S. Provisional Application No. 63/604,359, filed on Nov. 30, 2023, the entire contents of which are incorporated herein by reference. FIELD The present disclosure relates generally to the field of medical devices and methods, and more specifically to shock wave catheter devices for treating target material in body lumens, such as calcified lesions and fibrotic tissue. 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 2-4 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