US-12622718-B2 - Intravascular lithoplasty balloon systems, devices and methods

US12622718B2US 12622718 B2US12622718 B2US 12622718B2US-12622718-B2

Abstract

Various embodiments of the systems, methods and devices are provided for breaking up calcified lesions in an anatomical conduit. More specifically, an electrical arc is generated between two spaced-apart electrodes disposed within a fluid-filled balloon, creating flow and pressure waves. In some embodiments, the electrodes are spaced apart across relatively long distances to create a stronger shock. In some embodiments, the saline ionically conducting between the electrodes is confined to reduce parasitic heating. In some embodiments, the balloon is partially deflated during arc generation.

Inventors

J. Samuel Batchelder
John R. Ballard
Michael P. Brenzel
Alexander P. Thome

Assignees

CARDIOVASCULAR SYSTEMS, INC.

Dates

Publication Date: 20260512
Application Date: 20220805

Claims (20)

1 . An intravascular lithotripsy system comprising: an elongate member defining a lumen; a first set of two spaced-apart electrodes with a gap therebetween attached to the elongate member; a voltage pulse generator in electrical communication with the first set of two spaced-apart electrodes; an inflatable sleeve surrounding the at least one of the two spaced-apart electrodes and comprising a proximal end, a distal end, at least one inflated volume and at least one inflated diameter, the proximal end and the distal end of the sleeve both operatively attached to the elongate member, the inflatable sleeve being configured to be inflated with a fluid; an inflatable balloon that is configured to surround the inflatable sleeve, wherein the inflatable balloon is configured to be inflated with the fluid and comprising at least one inflated volume, wherein an inflated volume of the inflatable balloon comprises a volume that is at least two times greater than the at least one inflated volume of the inflatable sleeve that is surrounded by the balloon, wherein the inflatable sleeve is surrounded by the fluid within the inflatable balloon; and a fluid reservoir comprising the fluid and in fluid communication with an interior of the inflatable sleeve, wherein the interior of the inflatable sleeve is in fluid communication with the fluid within the inflated balloon and is configured to be inflated by passive or diffusive inflation with fluid from within the inflatable balloon, or by active inflation with the fluid from the fluid reservoir.
2 . The system of claim 1 , wherein the inflatable balloon comprises at least one inflated diameter and wherein the inflatable sleeve comprises at least one inflated diameter, wherein an inflated diameter of the inflatable balloon is at least two times greater than an inflated diameter of the inflated diameter of the inflatable sleeve.
3 . The system of claim 1 , further comprising: a fluid reservoir comprising the fluid and in fluid communication with an interior of the inflatable balloon, wherein the inflatable balloon is configured to be inflated and/or deflated by active inflation from, or deflation of the fluid into, the fluid reservoir.
4 . The system of claim 1 , wherein the inflatable sleeve comprises at least one flow channel disposed between an outer surface of the elongate member and the proximal end and/or distal end of the sleeve for fluid communication of the fluid between the interior of the inflatable balloon and the interior of the inflatable sleeve.
5 . The system of claim 1 , wherein the inflatable sleeve comprises one or more apertures through the sleeve.
6 . The system of claim 1 , wherein the inflatable sleeve constrains the volume of the fluid within the inflatable sleeve to a channel that fills the gap between the two spaced-apart electrodes, and wherein the inflatable sleeve does not touch the inflatable balloon when the inflatable sleeve and inflatable balloon are both inflated with the fluid.
7 . The system of claim 1 , wherein the gap between the first set of the two spaced-apart electrodes comprises a first gap between a first electrode and a second electrode; and a third electrode spaced away from the first electrode and in electrical communication with the voltage pulse generator, and comprising a second gap between the first electrode and the third electrode, and wherein the inflatable sleeve constrains the volume of fluid to a channel that fills the first and second gaps.
8 . The system of claim 7 , wherein the first gap between the first electrode and the second electrodes is within a range of 0.1 mm to 15 mm.
9 . The system of claim 1 , wherein the gap between the electrodes is within a range of 0.1 mm to 15 mm.
10 . The system of claim 1 , wherein the sleeve comprises a polymer.
11 . The system of claim 1 , wherein the sleeve comprises silicone.
12 . The system of claim 1 , further comprising a second set of two spaced-apart electrodes in electrical communication with the voltage pulse generator.
13 . The system of claim 12 , wherein the two spaced-apart electrodes are disposed within the inflatable sleeve.
14 . The system of claim 12 , further comprising another inflatable sleeve, each of the inflatable sleeve and the another inflatable sleeves defining a channel of fluid located within the inflatable balloon and operatively attached to the elongate member, and wherein the first set of two spaced-apart electrodes is disposed within the inflatable sleeve and wherein the second set of the two spaced-apart electrodes is disposed within the another inflatable sleeve, wherein the first and second sets of two spaced-apart electrodes are spaced longitudinally apart from each other.
15 . The system of claim 1 , wherein the inflatable sleeve is disposed against an insulated outer surface of each electrode of the first set of two spaced-apart electrodes.
16 . The system of claim 1 , wherein the sleeve is configured to be actively inflated with fluid from a fluid reservoir.
17 . An intravascular lithotripsy system comprising: an elongate member defining a lumen; two spaced-apart electrodes configured to be in electrical communication with a voltage pulse generator that is configured to apply voltage to one of the two spaced-apart electrodes and generate an arc therebetween, the arc launching a shock wave with a high peak wave pressure and a low tensile wave pressure and maximize electrical energy expended when the arc is initiated; a first fluid fillable member surrounding the two spaced-apart electrodes, the first fluid fillable member comprising a proximal end and a distal end, wherein the proximal end and the distal end is sealed to an outer surface of the elongate member, configured such that a fluid within the first fluid fillable member in an inflated configuration is constrained to a channel surrounding the two spaced-apart electrodes; and a fluid reservoir in fluid communication with an interior of the first fluid fillable member.
18 . The system of claim 17 , wherein the first fluid fillable member constrains a volume of fluid to the channel that fills a gap between the two spaced-apart electrodes, the channel being a narrow channel.
19 . The system of claim 18 , wherein the gap between the electrodes is within a range of 0.1 mm to 15 mm.
20 . The system of claim 17 , further comprising a third spaced-apart electrodes with a first gap between a first electrode of the two spaced-apart electrodes and a second electrode of the two spaced-apart electrodes and a second gap between the first electrode and a third electrode, and wherein the first fluid fillable member constrains a volume of fluid to the channel that fills the first and second gaps.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This is a 371 application based on PCT/US2022074607, filed Aug. 22, 2022, entitled INTRAVASCULAR LITHOPLASTY BALLOON SYSTEMS, DEVICES AND METHODS and claims the benefit of U.S. Provisional Patent Application Ser. No. 63/229,737, filed Aug. 5, 2021, entitled SYSTEMS, DEVICES AND METHODS FOR GENERATING SUBSONIC PRESSURE WAVES IN INTRAVASCULAR LITHOTRIPSY, U.S. Utility patent application Ser. No. 17/449,883, filed Oct. 4, 2021, entitled SYSTEMS, DEVICES AND METHODS FOR GENERATING SUBSONIC PRESSURE WAVES IN INTRAVASCULAR LITHOTRIPSY, U.S. Utility patent application Ser. No. 17/454,574, filed Nov. 11, 2021, entitled SYSTEMS, DEVICES AND METHODS FOR GENERATING SUBSONIC PRESSURE WAVES IN INTRAVASCULAR LITHOTRIPSY, U.S. Utility patent application Ser. No. 17/454,587, filed Nov. 11, 2021, entitled SYSTEMS, DEVICES AND METHODS FOR GENERATING SUBSONIC PRESSURE WAVES IN INTRAVASCULAR LITHOTRIPSY, U.S. Utility patent application Ser. No. 17/454,667, filed Nov. 12, 2021, entitled METHODS, SYSTEMS AND DEVICES FOR GENERATING SUBSONIC PRESSURE WAVES IN INTRAVASCULAR LITHOTRIPSY, U.S. Utility patent application Ser. No. 17/454,668, filed Nov. 12, 2021, entitled METHODS FOR GENERATING SUBSONIC PRESSURE WAVES IN INTRAVASCULAR LITHOTRIPSY WITH MORE THAN SPARK GAP, U.S. Utility patent application Ser. No. 17/454,718, filed Nov. 12, 2021, entitled SYSTEMS, DEVICES AND METHODS FOR SELECTION OF ARC LOCATION WITHIN A LITHOPLASTY BALLOON SPARK GAP, U.S. Utility patent application Ser. No. 17/454,721, filed Nov. 12, 2021, entitled SYSTEMS, DEVICES AND METHODS FOR MONITORING VOLTAGE AND CURRENT AND CONTROLLING VOLTAGE OF INTRAVASCULAR SUBSONIC LITHOTRIPSY SYSTEMS, and U.S. Utility patent application Ser. No. 17/644,173, filed Dec. 14, 2021, entitled LITHOPLASTY BALLOON SYSTEMS, DEVICES AND METHODS WITH ELECTRODE PAIRS HAVING MULTIPLE SPARK GAPS, the entire contents of which are incorporated herein by reference. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT None BACKGROUND OF THE INVENTION Field of the Invention The invention relates to systems, devices and methods for breaking up calcified lesions in an anatomical conduit. More specifically, an electrical arc is generated between two spaced-apart electrodes disposed within a fluid-filled member, creating flow and pressure waves. Description of the Related Art A variety of techniques and instruments have been developed for use in the removal or repair of tissue in arteries and similar body passageways, including removal and/or cracking of calcified lesions within the passageway and/or formed within the wall defining the passageway. A frequent objective of such techniques and instruments is the removal of atherosclerotic plaque in a patient's arteries. Atherosclerosis is characterized by the buildup of fatty deposits (atheromas) in the intimal layer (i.e., under the endothelium) of a patient's blood vessels. Very often over time what initially is deposited as relatively soft, cholesterol-rich atheromatous material hardens into a calcified atherosclerotic plaque, often within the vessel wall. Such atheromas restrict the flow of blood, cause the vessel to be less compliant than normal, and therefore often are referred to as stenotic lesions or stenoses, the blocking material being referred to as stenotic material. If left untreated, such stenoses can cause angina, hypertension, myocardial infarction, strokes and the like. Angioplasty, or balloon angioplasty, is an endovascular procedure to treat by widening narrowed or obstructed arteries or veins, typically to treat arterial atherosclerosis. A collapsed balloon is typically passed through a pre-positioned catheter and over a guide wire into the narrowed occlusion and then inflated to a fixed pressure. The balloon forces expansion of the occlusion within the vessel and the surrounding muscular wall until the occlusion yields from the radial force applied by the expanding balloon, opening up the blood vessel with a lumen inner diameter that is similar to the native vessel in the occlusion area and, thereby, improving blood flow. The angioplasty procedure presents some risks and complications, including but not limited to: arterial rupture or other damage to the vessel wall tissue from over-inflation of the balloon catheter, the use of an inappropriately large or stiff balloon, the presence of a calcified target vessel; and/or hematoma or pseudoaneurysm formation at the access site. Generally, the pressures produced by traditional balloon angioplasty systems is in the range of 10-15 atm, but pressures may at times be higher. As described above, the primary problem with known angioplasty systems and methods is that the occlusion yields over a relatively short time period at high stress and strain rate, often resulting in damage or dissection of the conduit, e.g., blood vessel, wall tissue. Shockwave Medical, Inc., markets an alternative to traditional relatively high pressure balloon a