Catheter system with multiple energy sources

Abstract

A catheter system for treating a stenosis in a body lumen includes a first energy source, a second energy source, and a catheter. The catheter includes an elongate member navigable through a body cavity; a first acoustic energy emitter connected to the first energy source and configured to emit acoustic energy when receiving energy from the first energy source; and a second acoustic energy emitter connected to the second energy source and configured to emit acoustic energy when receiving energy from the second energy source.

Description

Cross-reference to related applications

[0001] This patent application claims the benefit of U.S. Provisional Patent Application No. 63 / 535,302, filed August 29, 2023, and U.S. Provisional Patent Application No. 18 / 817,910, filed August 28, 2024, the entire contents of each of which are hereby incorporated herein by reference. Technical Field

[0002] This disclosure generally relates to the field of medical devices and methods, and more specifically to acoustic energy generating components for inclusion in catheter devices for treating lesions in body cavities, such as calcified lesions and occlusions in the vascular system. Background Technology

[0003] Calcifications in body cavities can adversely affect a patient's health. For example, when calcium accumulates in the walls of coronary arteries, calcification can restrict blood flow to the heart muscle, which can ultimately lead to a heart attack. Catheter devices are one type of device that can be used to treat calcifications in body cavities. When treating lesions with catheter devices, it is important to minimize damage to surrounding soft tissues while still destroying the lesion as much as possible.

[0004] Various catheters have been developed for treating calcified lesions, such as those in the vascular system associated with arterial disease. For example, treatment systems used in percutaneous coronary angioplasty or peripheral angioplasty use an angioplasty balloon to dilate the calcified lesion and restore normal blood flow to the vessel. In these types of procedures, a catheter carrying a balloon is advanced along a guidewire into the vascular system until the balloon is aligned with the calcified plaque. The balloon is then inflated (typically greater than 10 atm) to push the calcified plaque back into the vessel wall and dilate the occluded area of ​​the vascular system.

[0005] Recently, techniques and treatments for intravascular lithotripsy (IVL) have been developed, which is an interventional procedure used to improve calcified plaques in diseased arteries. The mechanism of plaque improvement is achieved through the use of a catheter with one or more acoustic shock wave generators located within a fluid that can generate acoustic shock waves to improve the calcified plaques. IVL devices vary in design regarding the energy source used to generate the acoustic shock waves, with two exemplary energy sources being electrohydraulic generation and laser generation.

[0006] For electrohydraulic generation of acoustic shock waves, a conductive solution (e.g., saline) can be contained within a shell surrounding the electrodes or flushed through a tube surrounding the electrodes. Improvement of calcified plaques is achieved by generating acoustic shock waves within the catheter through transelectrode discharge. This discharge generates one or more rapidly expanding vapor bubbles, thus producing acoustic shock waves. These shock waves propagate radially outward and improve calcified plaques within the blood vessel. For laser-generated acoustic shock waves, a laser pulse is transmitted into the fluid within the catheter and absorbed by the fluid. This absorption process rapidly heats the fluid and causes it to evaporate, generating rapidly expanding vapor bubbles and acoustic shock waves that propagate outward and improve calcified plaques. The intensity of the acoustic shock waves is higher if a fluid exhibiting strong absorption at the laser wavelength used is selected. These examples of IVL devices are not intended to comprehensively list all potential energy sources for generating IVL shock waves.

[0007] IVL (intravascular coagulation) can be considered different from standard atherosclerotic plaque resection because it breaks down calcium deposits but does not release them from the tissue. Therefore, IVL generally should not require aspiration or embolization protection. Furthermore, due to the compliance of normal vessels and non-calcified plaques, the shockwave generated by IVL does not alter normal vascular tissue or non-calcified plaques. In addition, IVL does not carry the same risk of perforation, anatomical changes, or other damage to the vascular system as atherosclerotic resection or angioplasty using cutting or scribing balloons.

[0008] More specifically, catheters for delivering IVL treatments have been developed that include electrode pairs for electrohydraulically generating shock waves within an angioplasty balloon. Shock wave devices can be particularly effective for treating calcified plaque lesions because the acoustic pressure from the shock waves can rupture or destroy the lesion near the angioplasty balloon without damaging surrounding tissue. In these devices, the catheter is advanced over a guidewire through the patient's vascular system until it is positioned proximal to and / or aligned with the calcified plaque lesion in the body cavity. The balloon is then inflated with a conductive fluid (e.g., using a relatively low pressure of 2 atm to 4 atm) to inflate it to contact the lesion, but not to the extent that it substantially displaces the lesion. Voltage pulses can then be applied across the electrodes in the electrode pair to generate an acoustic shock wave that propagates through the wall of the angioplasty balloon into the lesion. Once the acoustic shock wave ruptures the lesion, the balloon can be further inflated to increase the cross-sectional area of ​​the lumen and improve blood flow within the lumen. Alternative devices for delivering IVL therapy may include electrodes positioned within a closed volume other than an angioplasty balloon (such as a cap, a variable compliance balloon, or other types of shell). However, while known IVL techniques have shown great effectiveness in treating concentric calcium as well as intimal and subintimal calcium, they may not be particularly effective in treating eccentric calcified lesions or chronic total occlusion (CTO).

[0009] Laser atherosclerosis (LASIK) is an endovascular technique used to remove plaque from blood vessels within the body. Generally, this procedure uses a catheter with forward-guided (distal) ultraviolet energy to break up plaque buildup. However, existing LASIK devices have several drawbacks and may be ineffective for certain types of lesions, including intimal and subintimal stone deposits, which is increasingly concerning in the aging population.

[0010] Furthermore, treating relatively long lesions presents challenges to known IVL techniques. Currently available IVL catheters work by first inflating and securing an angioplasty balloon at the lesion site, then generating a series of shockwave pulses electrohydraulically. For relatively long lesions, after the first round of shockwave pulses, the angioplasty balloon can be deflated, advanced further down the lesion, and then re-inflated / secured for a second round of shockwave pulses. While longer balloons with five or more shockwave generation zones (each zone including one or more electrode pairs) are available, constructing even longer balloons and electrode assemblies presents manufacturing challenges, making such devices impractical.

[0011] Therefore, improved IVL devices are needed to treat cardiovascular diseases. Summary of the Invention

[0012] According to various embodiments, the catheter system includes a catheter having multiple acoustic energy emitters and one or more energy sources connected to the acoustic energy emitters. According to various embodiments, the catheter system includes acoustic energy emitters that emit acoustic energy with different acoustic characteristics for targeting different types of lesions and / or tissues. The catheters and catheter systems described herein can provide versatility in treating stenotic lesions of complex morphology, such as those involving multiple tissue types or lesions within very long and / or narrow body cavities.

[0013] According to various embodiments, a catheter for treating stenosis in a body cavity includes: an elongated member; a housing sealed to a distal region of the elongated member and capable of being filled with fluid; a forward-firing acoustic emitter located on the elongated member, at least partially outside the housing at a distal end of the housing; and a radially-firing acoustic emitter located on the elongated member, at least partially inside the housing.

[0014] A forward-firing acoustic transmitter can be optically connected to a light energy source. For example, a forward-firing acoustic transmitter can be optically connected to a light energy source via optical fiber.

[0015] The optical energy source may include a laser, and the forward-firing transmitter may include the distal end of an optical fiber.

[0016] A light source can emit infrared light. In some implementations, the light source can emit near-infrared light.

[0017] The radially fired acoustic emitter can be electrically connected to a voltage pulse generator.

[0018] Radial firing acoustic emitters may include electrode pairs.

[0019] The first electrode of the electrode pair may include a conductive surface of a strip, and the second electrode of the electrode pair may include a conductive portion of an elongated conductive member.

[0020] In some examples, radially fired acoustic emitters include more than one electrode pair.

[0021] The forward-firing acoustic transmitter can be electrically connected to a voltage pulse generator.

[0022] A forward-firing acoustic emitter may include a pair of electrodes.

[0023] A forward-firing acoustic energy transmitter may include both an electrode pair electrically connected to a voltage pulse generator and a light-emitting region optically connected to an optical fiber of light energy source.

[0024] A radially fired acoustic emitter can be optically connected to a light energy source.

[0025] Light energy sources can emit infrared lasers.

[0026] The light energy source can emit near-infrared lasers.

[0027] The light energy source can emit ultraviolet light. In some examples, the fluid may include a contrast agent with a high absorption rate for ultraviolet light.

[0028] The conduit may include a first radially fired acoustic emitter and a second radially fired acoustic emitter.

[0029] The first radially fired acoustic emitter can be electrically connected to a voltage pulse generator, and the second radially fired acoustic emitter can be optically connected to a light energy source.

[0030] Forward-firing and radial-firing acoustic emitters can be connected to different types of energy sources.

[0031] Forward-firing and radial-firing acoustic emitters can be connected to a single energy source.

[0032] Forward-firing and radial-firing acoustic emitters can be connected to a single energy source and connected in series.

[0033] Forward-firing acoustic emitters and radial-firing acoustic emitters can be connected to separate channels of the high-voltage generator.

[0034] According to various aspects of this disclosure, a catheter for treating stenosis in a body cavity includes an elongated member; a housing sealed to a distal region of the elongated member; a longitudinally movable member mounted at least partially around the elongated member and located inside the housing; a forward-firing acoustic emitter located on the elongated member, at least partially outside the housing and on the distal side of the housing; and a radially firing acoustic emitter located on the longitudinally movable member, at least partially inside the housing.

[0035] A forward-firing acoustic energy emitter may include the distal end of an optical fiber extending from a laser source.

[0036] A radially fired acoustic energy emitter may include the distal end of an optical fiber extending from a laser source.

[0037] Laser sources can generate lasers with wavelengths suitable for treating calcified lesions.

[0038] Laser sources can generate lasers with wavelengths suitable for treating tissues softer than calcium.

[0039] A laser source can generate laser light with a wavelength suitable for absorption by the target tissue.

[0040] Laser sources can generate laser light with wavelengths suitable for absorption by water.

[0041] According to various aspects of this disclosure, a catheter for treating stenosis in a body cavity includes: an elongated member; a housing sealed to a distal region of the elongated member and having a length of not less than 30 mm; and an emitter assembly movable along the longitudinal direction of the housing, the emitter assembly being at least partially located within the housing and including one or more light output regions.

[0042] According to various aspects of this disclosure, a method of treating a lesion in a blood vessel includes: advancing a catheter into the blood vessel until a distal end of the catheter is positioned close to the lesion; delivering energy to a distal acoustic emitter of the catheter; advancing the catheter such that a closed radially emitting acoustic emitter of the catheter is adjacent to the lesion; delivering energy to the closed radially emitting acoustic emitter to generate acoustic energy for further treatment of the lesion; and generating one or more pressure waves from the closed radially emitting acoustic emitter.

[0043] A radially fired acoustic emitter may include one of an electrode pair and the distal end of an optical fiber.

[0044] The method may further include expanding the outer shell of the conduit before delivering energy to the closed radially emitting acoustic emitter; moving the closed radially emitting acoustic emitter in the longitudinal direction of the conduit after delivering energy to the closed radially emitting acoustic emitter; and repeatedly generating one or more pressure waves from the radially emitting acoustic emitter.

[0045] Sound energy can be a shock wave.

[0046] The lesion can be a chronic total occlusion.

[0047] This method may include the step of imaging the lesion. Imaging can be performed, for example, by fluoroscopy, intravascular ultrasound, or optical coherence tomography.

[0048] The method may also include the step of tuning the acoustic characteristics of a distally fired acoustic emitter. For example, the acoustic wave output of the distally fired acoustic emitter may be adjusted. The acoustic characteristics can be tuned to match the physical properties of the target tissue.

[0049] According to various aspects of this disclosure, a catheter system for treating stenosis in a body cavity includes: a first energy source; a second energy source; and a catheter including: an elongated member configured to navigate through the body cavity; a first acoustic emitter connected to the first energy source and configured to emit acoustic energy when receiving energy from the first energy source; and a second acoustic emitter connected to the second energy source and configured to emit acoustic energy when receiving energy from the second energy source.

[0050] The conduit may include a housing, and the first and second acoustic emitters may be enclosed within the housing.

[0051] The first energy source can be a voltage pulse generator, and the second energy source can be a laser source.

[0052] The first energy source may be a first voltage pulse generator, and the second energy source may be a second voltage pulse generator configured to generate voltage pulses having electrical characteristics different from those generated by the first voltage pulse generator.

[0053] Both the first and second acoustic energy emitters can be open-cell.

[0054] The first energy source can be a first laser source, and the second energy source can be a second laser source that generates light with different light energy characteristics than the light generated by the first laser source.

[0055] The conduit may also include a third energy source, wherein the conduit includes a third acoustic energy transmitter connected to the third energy source. Attached Figure Description

[0056] The illustrative aspects of this disclosure are described in detail below with reference to the accompanying drawings. The embodiments and drawings disclosed herein are intended to be illustrative and exemplary, and not restrictive.

[0057] Figure 1 A catheter system for treating stenotic lesions in body cavities is shown according to various aspects of this disclosure.

[0058] Figure 2A The distal region of a conduit connected to more than one energy source is shown according to various aspects of this disclosure.

[0059] Figure 2B It shows Figure 2A A cross-sectional view of the conduit.

[0060] Figure 2C It shows Figure 2A and Figure 2B An enlarged cross-sectional view of the transmitter of the conduit.

[0061] Figure 3A The distal region of a conduit including both enclosed and unenclosed light-based acoustic energy emitters according to various aspects of this disclosure is shown.

[0062] Figure 3B A cross-sectional view of the catheter of claim 3A is shown.

[0063] Figure 4A and Figure 4B A conduit with a longitudinally translatable closed transmitter is shown according to various aspects of this disclosure.

[0064] Figure 4C and Figure 4D Another conduit with a longitudinally translatable closed transmitter is shown according to aspects of this disclosure.

[0065] Figure 5 A cross-sectional view of a conduit including an optical fiber as an energy conductor is shown according to various aspects of this disclosure.

[0066] Figure 6 A closed electro-hydraulic transmitter according to various aspects of this disclosure is shown.

[0067] Figure 7 A non-exposed electro-hydraulic emitter according to various aspects of this disclosure is shown.

[0068] Figure 8 A computing system for use with a catheter system is shown according to various aspects of this disclosure.

[0069] Figure 9Methods for treating stenotic lesions according to various aspects of this disclosure are shown.

[0070] Figure 10 Another method for treating stenotic lesions according to various aspects of this disclosure is shown. Detailed Implementation

[0071] The following description is intended to enable those skilled in the art to make and use the various embodiments and aspects disclosed herein. Descriptions of specific conduits, systems, methods, and applications are provided by way of example only. Various modifications to the examples described herein will be apparent to those skilled in the art, and the general principles described herein can be applied to other examples and applications without departing from the spirit and scope of its various embodiments and aspects. Therefore, its various embodiments and aspects are not intended to be limited to the examples described and illustrated herein, but are consistent with the scope of the claims.

[0072] As provided herein, it should be understood that any disclosure describing numerical ranges of dimensions or measurement results such as thickness, length, weight, time, frequency, temperature, voltage, current, angle, etc., includes any numerical increments or gradients relative to the range stated for a given dimension or measurement result. Furthermore, numerical indicators such as “first,” “second,” “third,” “fourth,” etc., are merely descriptive and do not indicate the relative order, position, or identity of the elements or features described by the indicator. For example, a “first” shock wave may be immediately followed by a “third” shock wave, and then a “second” shock wave. As another example, a “third” transmitter may be used to generate a “first” shock wave, and vice versa. Therefore, the numerical indicators of various elements and features are not intended to limit this disclosure and can be modified and interchanged.

[0073] Furthermore, in the following description, it should be understood that, unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the / described” used in the following description are intended to also include the plural forms. It should also be understood that, as used herein, the term “and / or” refers to and covers any and all possible combinations of one or more of the associated listed items. It should also be understood that, when used herein, the terms “comprising” and / or “including” specify the presence of the stated feature, integer, step, operation, element, component, and / or unit, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, units, and / or groups thereof. As provided herein, it should be understood that any disclosure describing a range of values ​​for dimensions or measurements such as thickness, length, weight, time, frequency, temperature, voltage, current, angle, etc., includes any numerical increments or gradients relative to the range stated for a given dimension or measurement.

[0074] As used herein, the term "electrode" refers to a conductive element (typically made of metal) that receives current and subsequently releases it to another conductive element. In the context of this disclosure, electrodes are typically positioned relative to each other, such as in an arrangement of inner and outer electrodes. Thus, as used herein, the term "electrode pair" refers to two electrodes positioned adjacent to each other such that applying a sufficiently high voltage to the electrode pair will cause current to be transmitted across the gap between the two electrodes (also known as a "spark gap") (e.g., from the inner electrode to the outer electrode and vice versa; optionally, electricity is transmitted through a conductive fluid or gas between them). In some contexts, one or more electrode pairs may also be referred to as an electrode assembly. In the context of this disclosure, the term "emitter" broadly refers to the region of the electrode assembly in which current is transmitted across the electrode pair, thereby generating a shock wave. The terms "emitter sheath" or "emitter strip" (these are used interchangeably) refer to a sheath / strip of conductive material that may form one or more electrodes in one or more electrode pairs, thereby forming one or more emitters.

[0075] The transmitter components, including electrodes and transmitter sheaths / bands, may be formed of metals such as stainless steel, copper, tungsten, platinum, palladium, molybdenum, cobalt, chromium, iridium, one or more alloys thereof, such as cobalt-chromium, platinum-chromium, cobalt-chromium-platinum-palladium-iridium, or platinum-iridium, or mixtures of such materials.

[0076] In some embodiments, the IVL catheter is a so-called "rapid-exchange" ("Rx") catheter, which has an opening through which a guidewire is guided (e.g., through the middle portion of the central tube in the longitudinal direction). In other embodiments, the IVL catheter may be an "integral guidewire" ("OTW") catheter, wherein the guidewire lumen is formed throughout the entire length of the catheter, and the guidewire is guided through the proximal end of the hub.

[0077] As provided herein, it should be understood that any disclosure describing a range of values ​​for dimensions or measurements such as thickness, length, weight, time, frequency, temperature, voltage, current, angle, etc. includes any numerical increments or gradients relative to the range stated for a given dimension or measurement.

[0078] In the following description of various implementation schemes, reference is made to the accompanying drawings, which illustrate specific implementation schemes that can be practiced. It should be understood that other implementation schemes and examples, and modifications, may be made without departing from the scope of this disclosure.

[0079] Efforts have been made to improve the design of electrode assemblies included in shock wave and directional cavitation catheters. For example, low-profile electrode assemblies have been developed that reduce the cross-sectional profile of the catheter and allow the catheter to more easily navigate calcified vessels to deliver shock waves in more severely occluded areas of the vascular system. Examples of low-profile electrode designs can be found in U.S. Patent Nos. 8,888,788, 9,433,428, and 10,709,462, U.S. Patent Publication No. 2021 / 0085383, and U.S. Patent Application No. 18 / 586,299, all of which are incorporated herein by reference in their entirety. Other catheter designs have improved shock wave delivery, for example, by specifically constructing and configuring the electrode to guide the shock wave in an anterior direction to disrupt tighter and more difficult-to-penetrate occlusions in the vascular system. Examples of forward-biased or firing-firing conduit designs can be found in U.S. Patent Nos. 10,966,737, 11,478,261, and 11,596,423, U.S. Patent Publications Nos. 2023 / 0107690 and 2023 / 0165598, and U.S. Patent Applications Nos. 18 / 524,575 and 18 / 680,853, the entire contents of which are incorporated herein by reference.

[0080] Figure 1 A shock wave duct system 10 with multiple energy sources according to aspects of this disclosure is shown. System 10 includes a shock wave duct 100 connected to a first energy source 152 and a second energy source 154. The shock wave duct 100 includes a housing 102, and acoustic energy emitters may be located inside and / or outside the housing 102. For example, one or more acoustic energy emitters may be located near the distal end 104 of the duct. The duct 100 is configured to emit acoustic energy generated by delivering energy from one or both of the first energy source 152 and the second energy source 154 to the emitters inside or outside the housing 102. Thus, the acoustic energy may be emitted distally (which may be referred to herein as “forward firing”) and / or radially (which may be referred to herein as “radial firing” or “lateral firing”). The shock wave duct system 10 may include a fluid supply source 130 connected to the duct 100 via a hub 120. The fluid supply source 130 may supply a conductive fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent).

[0081] Acoustic emitters can emit shock waves. In some implementations, the acoustic emitter generates cavitation bubbles, the collapse of which produces sound pressure waves and / or microjets.

[0082] The first energy source 152 and the second energy source 154 may include a high-voltage pulse generator, a laser source, or another energy source. Acoustic energy (e.g., shock waves and / or cavitation bubbles) may be generated from an electrohydraulic emitter (e.g., one or more electrode pairs that generate acoustic energy), a light emitter, a piezoelectric emitter, or an electromagnetic emitter (e.g., an acoustic energy generator that uses electromagnetic force to move fluid to generate shock waves and / or cavitation bubbles). In some embodiments, the first energy source 152 is connected to one or more unclosed emitters of the conduit 100 (those at or near the distal end 104), and the second energy source 154 is connected to one or more emitters enclosed within the housing 102. For example, if one of the energy sources is a high-voltage pulse generator, the energy source may be electrically connected to the electrode pairs of the acoustic energy emitter via a conductive member (e.g., a conductive wire). If one of the energy sources is a laser source, the energy source may be optically connected to the acoustic energy emitter via an optical transmission member (e.g., an optical fiber), which may include a light-emitting region of the optical transmission member. The first energy source 152 and the second energy source 154 may be part of an energy source subsystem 150, which includes various processors and software, as described below. Figure 8 Further description.

[0083] In some embodiments, the acoustic conduit system may include more than two energy sources (e.g., three, four, five, or more). Such systems are suitable for treating larger body cavities because including additional elongated energy guides can significantly increase the cross-sectional profile of the conduit. In some embodiments, an acoustic conduit system including a conduit with forward-firing and radial-firing transmitters has a single energy source that supplies energy to both the open (e.g., forward-firing) and closed (e.g., radial-firing) transmitters.

[0084] When power is supplied by a high-voltage pulse generator, a voltage pulse applied by the energy source can generate one or more shock waves at the transmitter via an electro-hydraulic mechanism. The voltage pulse from the high-voltage pulse generator (also referred to herein as a voltage source or voltage pulse generator) is typically in the range of approximately 500 volts to 3,000 volts (500V to 3,000V). In some specific implementations, the voltage pulse applied by the voltage source can be up to approximately 10,000 volts (10,000V) or higher. The pulse width of the applied voltage pulse is in the range of two microseconds to six microseconds (2μs to 6μs). The repetition rate or frequency of the applied voltage pulse can be between approximately 1 Hz and 10 Hz. The total number of pulses applied by the energy source can be, for example, sixty (60) pulses, eighty (80) pulses, one hundred and twenty (120) pulses, three hundred (300) pulses, or up to five hundred (500) pulses, or any pulse increment within that range. Alternatively or otherwise, in some examples, the energy source may be configured to deliver a group of micropulses having sub-frequency ranges from about 100 Hz to 10 Hz (100 Hz - 10 kHz). Preferred voltage, repetition rate, and number of pulses can vary depending on, for example, the size of the lesion, the degree of calcification, the size of the blood vessel, the patient's attributes, or the stage of treatment. For example, a physician may begin with a low-energy shockwave and increase the energy as needed during the procedure, or vice versa. The amplitude of the shockwave can be controlled by adjusting the voltage, current, duration, and repetition rate of the pulses from the energy source.

[0085] For implementations using light energy, in one or more embodiments, the energy source is selected from lasers having wavelengths from 100 nm to 10,000 nm. Certain light energy sources may be advantageous for generating sound pressure from the light energy. For example, neodymium-doped yttrium aluminum garnet (Nd:YAG) lasers, thulium:yttrium aluminum garnet (Tm:YAG) lasers, holmium:yttrium aluminum garnet (Ho:YAG) lasers, or erbium:yttrium aluminum garnet (Er:YAG) lasers can be used, but other lasers are also possible. For example, Er:YAG can be chosen because of its high water absorption.

[0086] In one or more embodiments, the catheter system 10, having forward-firing and radial-firing emitters, includes an ultraviolet laser as the energy source for the forward-firing emitter. In some embodiments, the system 10 includes an excimer laser as the energy source for one or more forward-firing emitters. Such lasers may have wavelengths from 126 nm to 351 nm. In some embodiments, the wavelength is about 308 nm. The wavelength may be selected based on the type of tissue to be ablated.

[0087] In some embodiments, the laser wavelength is tunable to be optimized for a specific tissue type. In some embodiments, one or both of energy sources 152, 154 include wavelength-switchable optical energy sources. Wavelength-switchable optical energy sources may, for example, include multiple optical energy sources emitting light of different wavelengths. Depending on the type (e.g., blood, saline, contrast solution), size, or composition of the fluid (e.g., fibrosis, coagulation, or calcification), the optimal wavelength of light from the multiple optical energy sources can be selected for the procedure. In some embodiments, if tissue modification is desired primarily through acoustic effects, a first optical energy source emitting light with a first wavelength can be selected, and if tissue modification is desired through direct tissue ablation by tissue absorption of light, a second optical energy source emitting light with a second wavelength can be selected. Once selected, the optical energy source emitting the selected wavelength can be optically coupled to an optical energy guide (e.g., an optical fiber or fiber bundle) to deliver the optical energy to one or more transmitters.

[0088] For soft tissue modification via direct tissue ablation, water can be used as a chromophore for light absorption. In some examples, light with wavelengths of 1400 nm–1520 nm or 1900 nm–2100 nm is used to modify soft tissue (to target the water absorption peak at 1470 nm or 2000 nm). For vascular tissue, oxyhemoglobin can be used as a chromophore for light absorption. In some examples, light with wavelengths of 410 nm–470 nm or 500 nm–560 nm is used to modify vascular tissue. In some examples, light with wavelengths of 480 nm–500 nm, 610 nm–650 nm, or 800 nm–900 nm is used to target calcified tissue. In some examples, light with wavelengths from approximately 405 nm to 1064 nm, 1470 nm, 1950 nm, 2000 nm, 2020 nm, 2120 nm, 2940 nm, or 9300 nm to 10,600 nm is used to modify soft tissues (e.g., tissues containing proteins and water). In some examples, light with wavelengths from approximately 2940 nm or 9000 nm to 10000 nm is used to modify denser tissues (e.g., tissues containing calcium minerals).

[0089] In some implementations, one or both of the energy sources 152 and 154 are infrared or visible laser sources, such as Tm:YAG lasers, InGaAs diode lasers, Nd:YAG lasers, pulsed dye lasers, holmium YAG lasers, or thulium fiber lasers or any other suitable laser. The light transmitted from one or both optical energy sources into the optical fiber of the conduit may have a near-infrared wavelength, i.e., a wavelength between about 760 nm and about 1500 nm. For example, the light transmitted from the light energy source 106 to the optical fiber in the conduit 102 may have a wavelength of approximately 800 nm, 820 nm, 840 nm, 860 nm, 880 nm, 900 nm, 920 nm, 940 nm, 960 nm, 980 nm, 1000 nm, 1020 nm, 1040 nm, 1060 nm, 1080 nm, 1100 nm, 1120 nm, 1140 nm, 1160 nm, 1180 nm, 1200 nm, 1220 nm, 1240 nm, 1260 nm, 1280 nm, 1300 nm, 1320 nm, 1340 nm, 1360 nm, 1380 nm, 1400 nm, 1420 nm, 1440 nm, 1460 nm, 1480 nm, or 2200 nm. In some embodiments, one or both of energy sources 152 and 154 are laser sources emitting light with a wavelength of about 1064 nm. In some embodiments, one or both of energy sources 152 and 154 are laser sources emitting light with a wavelength of about 1470 nm. Advantageously, near-infrared light exhibits strong absorption in water and is therefore suitable for use with aqueous solutions (such as salt water) to generate acoustic energy. However, other wavelengths of light can be selected; for example, ultraviolet energy sources, such as those described above, can be selected in combination with contrast agents.

[0090] The light energy source can be configured to provide light pulses. For a closed emitter, if the fluid is free (e.g., unclosed), the width of each light pulse can be less than the time required for a bubble to reach equilibrium in the fluid contained within the housing. In some embodiments, the width of each pulse is between 1 ns and 30 ns, between 5 ns and 25 ns, between 10 ns and 25 ns, or between 15 ns and 20 ns, for example, about 16 ns, about 17 ns, about 18 ns, about 19 ns, or about 20 ns. In other embodiments, the width of each pulse is between 50 ns and 500 μs, for example, 100 ns, 500 ns, 1 μs, 50 μs, 75 μs, 100 μs, 150 μs, 200 μs, 250 μs, 300 μs, 350 μs, 400 μs, or 450 μs. The peak power of each optical pulse can be between 100W and 500W, for example, approximately 150W, 200W, 250W, 300W, 350W, 400W, or 450W. The pulse repetition rate can be between approximately 100Hz and 1kHz, for example, approximately 150Hz, 200Hz, 250Hz, 300Hz, 350Hz, 400Hz, 450Hz, 500Hz, 550Hz, 600Hz, 650Hz, 700Hz, 710Hz, 720Hz, 730Hz, 740Hz, 750Hz, 760Hz, 770Hz, 780Hz, 790Hz, 800Hz, 810Hz, 820Hz, 830Hz, 840Hz, 850Hz, 900Hz, or 950Hz. Compared to the electro-hydraulic acoustic transmitters described above, acoustic transmitters powered by a light energy source can emit a significantly higher number of acoustic pulses before the transmitter and device deteriorate. In some embodiments, the light energy source can provide the device with up to 100,000 (100,000) light pulses. In some embodiments, the light energy source can provide the device with more than 100,000 (100,000) light pulses.

[0091] In some embodiments, the conduit 100 may include multiple forward-firing and / or radially firing transmitters optically connected to two or more light energy sources. The two or more light energy sources may generate light of different wavelengths. In some embodiments, a first light energy source may generate light pulses suitable for ablating tissue, and a second light energy source may generate light pulses suitable for generating acoustic energy. For example, the first light energy source may emit light with wavelengths absorbed by the target tissue, and the second light source may emit light with different wavelengths absorbed by a medium surrounding the transmitter (e.g., saline, plasma).

[0092] In some embodiments, the IVL catheter is a so-called "rapid-exchange" ("Rx") catheter, which has an opening through which a guidewire is guided (e.g., through the middle portion of the central tube in the longitudinal direction). In other embodiments, the IVL catheter may be an "integral guidewire" ("OTW") catheter, wherein the guidewire lumen is formed throughout the entire length of the catheter, and the guidewire is guided through the proximal end of the hub.

[0093] Based on all aspects of this disclosure, Figure 2A A perspective view of the distal end of catheter 200 is shown. Figure 2B A longitudinal sectional view is shown, and Figure 2C An enlarged longitudinal sectional view is shown. The conduit 200 may be included as part of a system (such as...). Figure 1 As part of the acoustic energy emission conduit system 10 shown, it includes one or more acoustic energy emitters 220 located on the distal end of the housing 210 and at least partially outside the housing. The acoustic energy emitters 220 can emit forward-guided acoustic energy generated by laser light energy (e.g., the aforementioned near-infrared or infrared wavelength light energy) at the distal end of the conduit 200 to open relatively tight (e.g., more occluded) calcified lesions. In some embodiments, the acoustic energy emitters 220 generate one or more cavitation bubbles propagating distally, the collapse of which emits acoustic energy (e.g., from shock waves and / or microjets) that can disrupt lesions located distal to the housing 210.

[0094] Optical fibers 222 and 224, which deliver laser energy from a laser source, are located inside or near the elongated axis 202 of the catheter 200. Each optical fiber 222 and 224 may be a flexible optical fiber or a bundle of optical fibers comprising multiple flexible optical fibers. Additional optical fibers may be included within the catheter 200 and distributed circumferentially around the central guidewire lumen 203. Optical fibers 222 and 224 may extend distally from the laser source to a distal emitter 220, which includes optical fiber ends 221 and 223 for distally emitting light energy. In such embodiments, optical fiber ends 221 and 223 may emit light energy to generate acoustic waves upon absorption by the surrounding medium and / or for ablation of target tissue.

[0095] like Figure 2A , Figure 2B and Figure 2CAs shown, catheter 200 includes multiple acoustic emitters 232, 234, 236 (e.g., shock wave generating regions) mounted on a fixed or longitudinally movable elongated shaft 202 and enclosed within a housing 210 to target calcified lesions in a body cavity. When inflated, the diameter of housing 210 (e.g., balloon) can range from 2 mm to 5 mm; housing 110 can be longer than those used with existing commercially available IVL devices. In some embodiments, housing may include an angioplasty balloon with a working length greater than 80 mm. In some embodiments, housing may include an angioplasty balloon with a working length greater than 10 cm. In one or more embodiments, the working length of housing (e.g., the generally tubular region of the angioplasty balloon) can be up to 300 mm. In some embodiments, the working length of housing is up to 200 mm. In one or more embodiments, the working length is not less than 30 mm. In other embodiments, the working length is not less than 50 mm.

[0096] like Figure 2C As shown in the enlarged cross-sectional view, the electro-hydraulic acoustic energy transmitter (such as transmitters 232, 234, 236) located inside the housing 210 may include one or more electrode pairs 231, 233. The first electrode of the electrode pairs 231, 233 may include an outer electrode formed by conductive surfaces 2312, 2314 with a band 2300. Figure 2C As shown, conductive surfaces 2312 and 2314 may be located on the vias of strip 2300. In other embodiments, the conductive surfaces may be located on other regions, such as the distal or proximal edge of strip 2300. Additional vias may be provided in strip 2300 to form additional conductive surfaces and electrode pairs.

[0097] The second electrode of electrode pair 231, 233 may include conductive regions 2322, 2324 of elongated conductive members 2321, 2323, and may be provided as an internal electrode of electrode pair 231, 233. In some examples, conductive regions 2322, 2324 include exposed (non-insulated) regions of elongated conductive members 2321, 2323. In other examples, one or both internal electrodes of electrode pair 231, 233 may be formed by other conductive members (such as stainless steel sheaths) directly and electrically connected to elongated conductive members 2321, 2323. Elongated conductive members 2321, 2323 may then be electrically connected to the positive and negative terminals of a high-voltage pulse generator. In various embodiments, elongated conductive members 2321, 2323 are insulated wires.

[0098] In an electro-hydraulic example of the acoustic wave transmitter, each electrode pair includes a gap separating the two electrodes. When a high-voltage pulse (up to 10 kV) is delivered to the elongated conductive members 2321, 2323, current can (a) flow from the first inner electrode (e.g., conductive region 2322), (b) flow across the gap of the first electrode pair (e.g., electrode pair 231), (c) flow to the first outer electrode (e.g., conductive surface 2312 of strip 2300), (d) flow along strip 2300 to the second outer electrode (e.g., conductive surface 2314 of strip 2300), and (e) flow across the gap of the second electrode pair (e.g., conductive region 2324). An insulating sleeve 2340 can be positioned between the elongated shaft 202 and the strip 2300. The insulating sleeve 2340 can be provided with a hole aligned with the hole in the strip 2300 and is formed of an insulating polymer (such as polyimide or polyurethane). At each electrode pair 231, 233, a shock wave can be generated when current is delivered through the corresponding gap. Therefore, each acoustic transmitter 232, 234, 236 may include more than one electrode pair connected in series with each other. Furthermore, two or more acoustic transmitters 233, 234, 236 may be connected in series with each other, such that a single high-voltage pulse generates a shock wave at each electrically connected electrode pair and transmitter.

[0099] Figure 6 A transmitter 600, such as transmitters 232, 234, and 236, is shown as a transmitter that can form a closed transmitter assembly, wherein transmitter 600 is electrically connected in series with one or more transmitters. Transmitter assembly 600 includes electrode pairs 610. Electrode pairs 610 may include a first electrode 612 and a second electrode 614. The first electrode 612 may be formed from the surface of a conductive outer member 620. In some embodiments, the conductive outer member may be a conductive strip with a hole on the surface of which the first electrode 612 is formed. The second electrode 614 may be formed from a conductive inner member 615 electrically connected to a high-voltage generator. A wire 617 may electrically connect the conductive outer member 620 to another adjacent conductive outer member. For example, wire 617 may form an inner electrode at an adjacent conductive member. A wire 630 may be insulated from and extend below the conductive outer member 620 to serve as a return wire from the adjacent conductive outer member to the high-voltage generator.

[0100] Other electrode pair configurations for the enclosed transmitter are possible. In some examples, the electrode pair may be formed from non-insulated portions of conductive wires separated by a gap, wherein the conductive wires are connected to the positive and negative terminals of the high-voltage generator. In other examples, the electrode pair may be formed from adjacent conductive edges of spaced-out strips or loops.

[0101] Figure 2A , Figure 2B and Figure 2CMultiple enclosed acoustic energy emitters 232, 234, 236 are depicted as electro-hydraulic shock wave emitters, but in other embodiments, and as described in more detail below, these acoustic energy generating regions can generate shock waves (or pressure pulses) from an optical energy source (e.g., a laser), which may be the same as or different from the optical energy source optically connected to the shock wave emitter 220.

[0102] The elongated shaft 202 includes a guidewire lumen 203 for the guidewire 205, through which the catheter can be delivered to the treatment site. In one or more embodiments, the catheter 200 includes an additional lumen for delivering fluid (e.g., a conductive fluid) to fill or expand the outer shell. In one or more embodiments, the catheter 200 includes an additional lumen extending proximal to the distal transmitter 220 to inject fluid into the distal transmitter 220 and / or aspirate the treatment site during or after treatment.

[0103] Components of an electro-hydraulic transmitter, including electrodes and transmitter sheaths / bands, may be formed of metals such as stainless steel, copper, tungsten, platinum, palladium, molybdenum, cobalt, chromium, iridium, one or more alloys thereof, such as cobalt-chromium, platinum-chromium, cobalt-chromium-platinum-palladium-iridium, or platinum-iridium, or mixtures of such materials.

[0104] In other embodiments, the emitter type can be varied, such that an electrohydraulic emitter fires forward-guided cavitation bubbles (e.g., using the electrode design described in U.S. Patent Publication No. 2023 / 0165598), and radial pressure waves (e.g., shock waves) are generated by a laser within the housing. Other combinations are possible (such as both forward-firing and radially-firing electrohydraulic emitters, or both forward-firing and radially-firing laser emitters). Other embodiments include other types of pressure wave generating emitters, such as those employing piezoelectric elements.

[0105] In some embodiments, the acoustic conduit includes a distally unsealed electrohydraulic emitter. Such conduits may include... Figure 7 The transmitter 700 shown serves as a remote transmitter. The transmitter 700 includes a conductive region 712 of a conductive elongated member 710 serving as the first electrode of an electrode pair. The elongated member 710 can be electrically connected to a high-voltage generator. The conductive edge 722 of the strip 720 can form the second electrode of the electrode pair. A return wire 740 can electrically connect the strip 720 to the high-voltage generator. An insulating layer 740 ensures that the electrodes do not contact each other. Although Figure 7A conductive region 712 serving as the inner electrode and a conductive edge 722 serving as the outer electrode are shown, but other configurations are possible. In some embodiments, the conductive region of the elongated member 710 may form the outer electrode, and the strip 720 may form the inner electrode. In some embodiments, the strip 720 may include a slit or slot, and the elongated member 710 may be positioned within the slit or slot. Furthermore, the distal emitter 700 may include more than one electrode pair. In some embodiments, the distal emitter may include two electrode pairs connected in series.

[0106] In some embodiments, wires 710 and 730 extend along or through a dedicated lumen of an elongated shaft (e.g., shaft 202 mentioned above) to the high-voltage generator. Conduits with distally unsealed and sealed electro-hydraulic transmitters can be used with a high-voltage generator having separate dedicated channels for the unsealed and sealed transmitters. In some embodiments, the unsealed transmitter can be connected to a first high-voltage generator, and the sealed transmitter can be connected to a second high-voltage generator. Such systems can allow for separate control of the unsealed and sealed transmitters and may require adaptation to different power or safety requirements of these methods of operation. In some embodiments, the unsealed transmitter is provided with a lower amplitude voltage pulse than the sealed transmitter. In some embodiments, the unsealed transmitter is provided with a different pulse frequency than the sealed transmitter. In some embodiments, the unsealed transmitter is provided with a higher frequency and lower amplitude pulse than the sealed transmitter.

[0107] In some embodiments, the unenclosed distal transmitter 700 is electrically connected to one or more enclosed transmitters via wires 710, 730. In such embodiments, a high-voltage pulse can generate acoustic energy (e.g., from a shock wave or the collapse of a cavitation bubble) at the electrode pairs of the unenclosed distal transmitter 700 and the enclosed transmitters. The unenclosed distal transmitter 700 can be electrically connected in series to one or more enclosed transmitters via wires 710, 730.

[0108] Figure 3A A perspective view of the acoustic energy emitting conduit 300 according to various aspects of this disclosure is shown, and Figure 3BA perspective cross-sectional view of the device is shown. Similar to conduit 200, conduit 300 includes one or more unclosed acoustic emitters 320 and closed acoustic emitters 332, 334, 336, and 338 enclosed within a fluid-filled housing 310. Compared to conduit 200, each of the closed acoustic emitters of conduit 300 is formed by one or more luminescent regions of an optical fiber. For example, emitter 332 includes the distal end of optical fiber 331; emitter 334 includes the distal end of optical fiber 333; emitter 336 includes the distal end of optical fiber 335; and emitter 338 includes the distal end of optical fiber 337. In other embodiments, one or more of the closed emitters may be formed by a fading portion of an optical fiber, which is not necessarily the distal end of the optical fiber (e.g., a portion of an optical fiber with a thinning cladding region). In some embodiments, each emitter may include luminescent regions of multiple optical fibers (e.g., the distal ends of a bundle of optical fibers).

[0109] Optical fibers 331, 333, 335, and 337 may extend substantially longitudinally along the length of the conduit 300, parallel to the elongated axis 302. Each optical fiber 331, 333, 335, and 337 may have a bend near its distal end, such that the distal end of each optical fiber 331, 333, 335, and 337 is angled away from the distal end of the conduit 300. In some embodiments, each optical fiber 331, 333, 335, and 337 includes a bend near its distal end, such that the distal end of each optical fiber 331, 333, 335, and 337 is angled away from the distal end of the conduit 300 by 5 to 90 degrees. In some embodiments, this angle is less than 90 degrees. In some embodiments, the distal end of one or more of the optical fibers 331, 333, 335, and 337 is positioned such that light is emitted from the distal end from the elongated axis 302 in the transverse direction (radially outward). In some implementations, the distal ends of one or more of the optical fibers 331, 333, 335, and 337 are positioned such that light emitted from the distal ends is biased in the distal direction of the conduit 300.

[0110] In the proximal region of conduit 300, enclosed transmitters 332, 334, 336, and 338 can be optically coupled to one or more optical energy sources via optical fibers 331, 333, 335, and 337. In some embodiments, each of the enclosed transmitters is coupled to the same optical energy source.

[0111] For light energy to be absorbed by the fluid within the housing to generate acoustic energy (e.g., from a shock wave), it may be important that the enclosed emitters 332, 334, 336, 338 are spaced from the housing 310 at a distance equal to or greater than the depth of light absorption in the fluid. In some embodiments, during use (e.g., during expansion), the housing 310 is spaced from the enclosed emitters 332, 334, 336, 338 at a distance of not less than 1.0 mm. In some embodiments, when the depth of light absorption is short due to the characteristics of one or both of the light or the fluid, the enclosed emitters may be spaced less than 1.0 mm from the housing. In some embodiments, the enclosed emitters may be spaced close to 0.1 mm from the housing. The enclosed emitters may be spaced no more than 5.0 mm from the housing to ensure sufficient sound pressure reaches the therapeutic target.

[0112] The elongated shaft 302 includes a guidewire lumen 303 through which the catheter can be delivered to the treatment site. In one or more embodiments, the catheter 300 includes an additional lumen for delivering fluid (e.g., a conductive fluid) to fill or expand the outer shell. In one or more embodiments, the catheter 300 includes an additional lumen extending near the distal transmitter 320 for delivering fluid and / or aspirating the distal treatment area.

[0113] like Figure 3B As shown, enclosed radially firing (or laterally firing) transmitters 332, 334, 336, 338 and optical fibers 331, 333, 335, 337 are embedded or mounted on an outer shaft 340 positioned around the elongated member 302. In some embodiments, the outer shaft 340 may be integrally formed with the elongated member 302. In some embodiments, the outer shaft 340 is made of a polymeric material. For example, the outer shaft 340 may be at least partially made of polycarbonate, acrylonitrile butadiene styrene, polybutylene terephthalate, polyetheretherketone, combinations of such polymers, or another material with similar properties.

[0114] According to one or more embodiments, a dual-source catheter including a photoelectric energy source can selectively emit laser energy from a laser having a specific wavelength to most effectively ablate hard and long calcified lesions, as well as remove soft plaque lesions. In other words, the laser wavelength can be selected based on the type of tissue to be ablated. In some embodiments, where the lesion has been at least partially opened by laser ablation from a non-closed distal emitter (e.g., distal emitter 220 or 320), the catheter can be further inserted to allow an electrohydraulic emitter (or another type of radially fired emitter) to rupture the calcified lesion.

[0115] The wavelength of the laser used for both closed and open-type emitters can be selected to target one or more types of lesions. For example, a forward-firing laser wavelength can be selected to optimally target fibrotic tissue for ablation, and a radially-firing laser wavelength can be selected to generate acoustic pressure in saline to optimally target calcified lesions. Alternatively, a forward-firing laser wavelength can be selected to generate acoustic pressure (instead of photoablation) to target the lesion of interest. In such embodiments, the catheter may include a photoacoustic transducer for converting light energy into mechanical energy.

[0116] In some implementations, the catheter may include an electrohydraulic acoustic emitter and a light-based acoustic emitter within a housing (such as an angioplasty balloon). Such catheters may include emitter bands and conductive elongated members forming electrode pairs for the electrohydraulic emitter and light-emitting portions of one or more optical fibers for the light-based acoustic emitter. Combining two types of acoustic emission sources within the housing allows the catheter to generate acoustic energy with a wider range of acoustic properties to treat, for example, different types of lesions. Additionally, including a light-based emitter can help reduce the cross-sectional profile of catheters with only an electrohydraulic emitter.

[0117] In some embodiments, the catheter may include an electrohydraulic acoustic energy emitter and a light-based acoustic energy emitter outside the outer casing. Such catheters may include one or more electrode pairs (such as any of the unencapsulated electrode pairs described herein) and one or more light-emitting regions of one or more optical fibers at the distal end of the catheter. In one embodiment, one or more optical fibers are optically connected to a light energy source that emits light with wavelengths suitable for absorption by a first target tissue. The one or more electrode pairs may be configured to emit acoustic energy tuned to disrupt a second target tissue. In this way, catheter systems with multiple energy sources can be used to treat lesions of various tissue types.

[0118] Figure 4A and Figure 4B A cross-sectional view is depicted of the distal end of an acoustic conduit 400 having longitudinally translatable closed acoustic emitters according to one or more embodiments. The conduit 400 includes one or more forward-firing light emitters 420 at its distal end for disrupting occluded body cavities. The conduit 400 includes closed acoustic emitters 432, 434, 436, 438 that are longitudinally (in a distal to proximal direction) movable within a housing 410 (e.g., an angioplasty balloon) to treat relatively long lesions. Importantly, this mobility of the acoustic emitters 432, 434, 436, 438 allows treatment of long lesions without requiring the housing 410 to deflate, move, and re-inflate.

[0119] Optical fibers 431, 433, 435, and 437 can be flexible optical fibers or fiber bundles. Transmitters 432, 434, 436, and 438 can each include a light-emitting region of optical fiber 431, 433, 435, or 437. For example, a transmitter can be formed at the distal end of the optical fiber. In some embodiments, one or more evanescent regions of an optical fiber with a thinned cladding can form one or more transmitters.

[0120] One or more acoustic emitters can be mounted on a longitudinally movable outer shaft 440 to target long lesions (e.g., lesions longer than 10 mm). According to these embodiments, the balloon size is in the range of 2.5 mm to 12 mm in diameter, and using these movable emitters, longer balloons can be made up to 200 mm in length.

[0121] In one or more embodiments, the acoustic conduit 400 includes a guidewire lumen 403 defining the central axis of the conduit 400 and multiple optical fibers 421 located all or part of the guidewire lumen (e.g., Figure 4A and Figure 4B (As shown). Fiber 421 can be optically connected at its proximal end to the same or different optical energy source as fibers 431, 433, 435, and 437. In some examples, conduit 400 is configured such that transmitter 420 has different laser energy characteristics than transmitters 432, 434, 436, and 438. Transmitter 420 can, for example, be configured with optical energy of different wavelengths, power densities, or pulse widths.

[0122] Figure 4C and Figure 4D A cross-sectional view is depicted of the distal end of an acoustic conduit 400' with longitudinally translatable closed acoustic emitters according to one or more embodiments. The conduit 400' includes one or more forward-firing light emitters 420' at its distal end for disrupting occluded body cavities. The conduit 400' includes closed electrohydraulic acoustic emitters 432', 434', 436', 438' that are longitudinally (in a distal to proximal direction) movable within a housing 410' (e.g., an angioplasty balloon) to treat relatively long lesions. Similar to the conduit 400, the mobility of the acoustic emitters 432', 434', 436', 438' allows treatment of long lesions without requiring the housing 410' to deflate, move, and re-inflate. The acoustic energy conduit 400' includes a guidewire lumen 403' that defines the central axis of the conduit 400, and acoustic energy emitters 432', 434', 436', and 438' that can move along the central axis.

[0123] Each electro-hydraulic acoustic energy transmitter in conduit 400' includes one or more electrode pairs that emit shock waves when a high-voltage pulse is delivered across the spark gap of one or more electrode pairs. The electrode pairs can be electrically connected such that a single high-voltage pulse from a high-voltage generator produces a shock wave from each electrode pair.

[0124] One or more acoustic emitters can be assembled on a longitudinally movable outer axis 440' to target long lesions (e.g., lesions longer than 10 mm). According to these embodiments, the balloon size has a diameter ranging from 2.5 mm to 12 mm, and using these movable emitters, longer balloons up to 200 mm in length can be achieved. Advantageously, the electrohydraulic acoustic emitter can be electrically connected to a high-voltage source via a wire, which can be more easily integrated into the movable emitter catheter compared to light-based acoustic emitters that require coupling a light guide to a light energy source.

[0125] Figure 5 A cross-sectional view of a catheter 500 at a proximal location (i.e., proximal to the transmitter and any housing) according to various aspects of this disclosure is shown. The catheter 500 includes a guidewire lumen 503 for receiving a guidewire 505, through which the catheter 500 is delivered to the treatment site. The catheter 500 includes multiple optical fibers 510 (e.g., a single fiber or a bundle of fibers). In a distal region, these optical fibers may be positioned such that the luminescent region of the fiber forms an acoustic emitter of the catheter 500, such as a distally unclosed emitter and a closed emitter. In some embodiments, the guidewire lumen 503 may be centered within the catheter, or in other embodiments, the guidewire lumen may be offset from the axial center. The guidewire lumen may range from 0.01 inches to 0.05 inches. In some examples, the guidewire lumen is 0.014 inches. In some examples, the guidewire lumen is 0.018 inches. In some examples, the guidewire lumen is 0.035 inches. The catheter diameter may range from less than 1 mm to a maximum of 5 mm.

[0126] Figure 8 An example of a computing system 800 is shown, which can be used for Figure 1The system 800 may include one or more components of the catheter 100 system, such as a subsystem 150 for controlling the delivery of energy to the catheter 100. The system 800 may be a computer connected to a network, such as one or more networks of a hospital, including local area networks within rooms of the medical facility and networks linking different parts of the medical facility, or a wide area network accessed via the Internet or other means. The system 800 may be a client or a server. The system 800 may be any suitable type of processor-based system, such as a personal computer, workstation, server, handheld computing device (portable electronic device), such as a telephone or tablet, or a dedicated device. The system 800 may include, for example, one or more of an input device 820, an output device 830, one or more processors 810, a storage device 840, and a communication device 860. The input device 820 and the output device 830 may generally correspond to those devices described above and may be connected to or integrated with a computer.

[0127] Input device 820 can be any suitable device that provides input, such as a touchscreen, keyboard or keypad, mouse, gesture recognition component of a virtual / augmented reality system, or voice recognition device. Output device 830 can be or includes any suitable device that provides output, such as a display, touchscreen, haptic device, virtual / augmented reality display, or speaker.

[0128] Storage device 840 can be any suitable device providing storage, such as electrical, magnetic, or optical memory including RAM, cache, hard disk drive, removable storage disk, or other non-transitory computer-readable media. Communication device 860 can include any suitable device capable of transmitting and receiving signals over a network, such as a network interface chip or device. Components of computing system 800 can be connected in any suitable manner, such as via a physical bus or wirelessly.

[0129] Processor 810 can be any suitable processor or combination of processors, including any or any combination of a central processing unit (CPU), a field-programmable gate array (FPGA), and an application-specific integrated circuit (ASIC). Software 850, which can be stored in storage device 840 and executed by one or more processors 810, may include, for example, programming embodying the functionality or features of this disclosure (e.g., as embodied in the apparatus described above), such as programming for performing one or more steps of method 200, method 300, and / or method 600.

[0130] Software 850 may also be stored and / or transmitted in any non-transitory computer-readable storage medium for use by or in conjunction with an instruction execution system, device, or apparatus (such as those described above), from which the instruction execution system, device, or apparatus may retrieve and execute instructions associated with the software. In the context of this disclosure, a computer-readable storage medium may be any medium, such as storage device 840, which may contain or store programs for use by or in conjunction with an instruction execution system, device, or apparatus.

[0131] The software 850 can also be propagated within any transmission medium for use by or in conjunction with an instruction execution system, device, or apparatus (such as those described above), from which the system, device, or apparatus may retrieve and execute instructions associated with the software. In the context of this disclosure, the transmission medium can be any medium capable of communicating, propagating, or transmitting a program for use by or in conjunction with an instruction execution system, device, or apparatus. Transmission computer-readable media can include, but are not limited to, electronic, magnetic, optical, electromagnetic, or infrared wired or wireless propagation media.

[0132] System 800 may include sensor device 870, which provides sensor data for processing by processor 810. In some embodiments, sensor device 870 may be an imaging sensor that provides imaging data for the lesion being treated. In some embodiments, sensor device 870 may be a voltage sensor, current sensor, pressure sensor, temperature sensor, electromagnetic sensor, or optical sensor for providing data on the state of the catheter or lesion. Depending on the type of sensor used, sensor device 870 may be physically located on the catheter along the area configured to enter the patient, or may be incorporated into a portion of the catheter system that remains outside the patient during treatment. In some embodiments, sensor device 870 may include one or more of the sensor types identified herein in any combination. In some specific embodiments, data collected by sensor device 870 may be displayed on output device 830, modified or corrected via input device 820, saved to storage device 840, transmitted via communication device 860 to a separate system, or any combination thereof.

[0133] System 800 can be connected to a network, which can be any suitable type of interconnected communication system. The network can implement any suitable communication protocol and can be protected by any suitable security protocol. The network can include any suitable network link that can implement the transmission and reception of network signals, such as wireless network connections, T1 or T3 lines, cable networks, DSL, or telephone lines.

[0134] System 800 can implement any operating system suitable for operation on a network. Software 850 can be written in any suitable programming language, such as C, C++, Java, or Python. In various examples, application software embodying the functionality of this disclosure can be deployed in different configurations, such as client / server deployment, or deployed as a web-based application or web service via a web browser.

[0135] System 800 can be configured to selectively control energy delivery from one or more energy sources (e.g., voltage pulse generators or light energy sources) to one or more acoustic transmitters (e.g., forward-firing transmitters, radial-firing transmitters, unclosed transmitters, or closed transmitters) based on input from input device 820.

[0136] System 800 can be configured to tune the energy characteristics of one or more of the energy delivered to the aforementioned transmitters based on tissue characteristics received from sensor device 870. Tissue characteristics may include lesion tissue type (e.g., calcification, coagulation, fibrosis) and lesion morphology (e.g., thickness, length, eccentricity).

[0137] How to use

[0138] Figure 9 An exemplary method for treating a stenotic lesion according to one or more aspects of the present invention is illustrated. In one or more embodiments, the method for treating a stenotic lesion includes one or more of the following steps: at step 901, imaging the lesion (e.g., by one or more of angiography, intravascular ultrasound, optical coherence tomography); at step 902, advancing the distal end of a dual-energy-source catheter to the lesion; optionally, at step 903, tuning the energy characteristics of the distal emitter (e.g., selecting a laser wavelength or adjusting the electrical characteristics (amplitude, frequency, pulse width) of a high-voltage pulse to ablate the lesion and / or generating cavitation bubbles at the distally unclosed emitter); at step 904, Energy is delivered to a distal emitter (e.g., by firing light energy in a forward direction (distal to the distal end of the catheter) or by delivering current across one or more electrode pairs) to generate acoustic energy for destroying the lesion; at step 905, the catheter is further advanced into the body cavity to locate one or more enclosed shock wave emitters adjacent to the lesion; at step 906, the outer shell of the catheter is filled with fluid (e.g., expanded with saline to 1 atm to 4 atm); at step 907, a shock wave is generated from one or more enclosed shock wave emitters by delivering energy pulses (e.g., from a laser pulse or a high-voltage pulse).

[0139] Figure 10An exemplary method for treating a stenotic lesion according to one or more aspects of the present invention is illustrated. In one or more embodiments, the method for treating a stenotic lesion includes one or more of the following steps: at step 1001, imaging the lesion (e.g., by one or more of angiography, intravascular ultrasound, optical coherence tomography); at step 1002, advancing the distal end of a dual-energy-source catheter to the lesion; optionally, at step 1003, tuning the energy characteristics of the distal transmitter (e.g., selecting a laser wavelength or adjusting the electrical characteristics (amplitude, frequency, pulse width) of a high-voltage pulse to ablate the lesion and / or generating cavitation bubbles at the distally unclosed transmitter); at step 1004, delivering energy to the distal transmitter (e.g., in an anterior direction (away from the distal end of the catheter) towards the distal end). (Side) emitting light energy or delivering current across one or more electrode pairs to generate acoustic energy for destroying the lesion; at step 1005, the catheter is further advanced into the body cavity to position one or more radial shock wave emitters adjacent to the lesion; at step 1006, the outer shell of the catheter is filled with fluid (e.g., expanded to 1 atm to 4 atm with saline); at step 1007, a shock wave is generated from one or more enclosed shock wave emitters by delivering energy pulses (e.g., from laser pulses or high-voltage pulses); at step 1008, the enclosed shock wave emitters are translated to different positions within the outer shell; at step 1009, a shock wave is generated from one or more enclosed shock wave emitters by delivering energy pulses.

[0140] Without departing from this disclosure, the elements and features of the exemplary conduits and conduit systems shown throughout this specification and accompanying drawings may be rearranged, recombined, and modified. For example, without departing from this disclosure, the number, placement, and spacing of shock wave generating regions or emitters may be modified, as may the number, placement, and spacing of conduit housings.

[0141] Although the catheter devices described herein are primarily discussed in the context of treating coronary artery occlusions (such as lesions in the vascular system), they can be used for various occlusions, such as those in the peripheral vascular system (e.g., above the knee, below the knee, iliac bone, carotid artery, etc.). For additional examples, various implementations can be used to treat soft tissues, such as cancers and tumors (i.e., non-thermal ablation methods), blood clots, fibromas, cysts, organs, scars, and fibrotic tissue removal, or other tissue destruction and removal treatments. Electrode assemblies and catheter designs can also be used for neurostimulation therapy, targeted drug delivery, treatment of tumors in body cavities (e.g., tumors in blood vessels, esophagus, intestines, stomach, or vagina), wound management, non-surgical resection and tissue destruction, or as an alternative to thermal treatment or cauterization for venous insufficiency and tubal ligation (i.e., for permanent female contraception).

[0142] In one or more examples, the electrode assemblies and catheters described herein can also be used in tissue engineering approaches, such as for mechanical tissue decellularization to produce bioactive scaffolds in which new cells (e.g., exogenous and endogenous cells) replace old cells; and for introducing porosity to sites to improve cell retention, cell infiltration / migration, and diffusion of nutrients and signaling molecules, thereby promoting angiogenesis, cell proliferation, and tissue regeneration, similar to cell replacement therapy. Such tissue engineering approaches can be used to treat ischemic heart disease, fibrotic liver, fibrotic intestine, and traumatic spinal cord injury (SCI). For example, for treating spinal cord injury, the devices and assemblies described herein can facilitate the removal of scarred spinal cord tissue prior to the injection of an anti-inflammatory hydrogel loaded with lentiviruses to genetically engineer spinal cord neuronal regeneration, acting as a barrier to neuronal reconnection.

[0143] It should be understood that the foregoing is illustrative only, and various modifications, alterations, and combinations can be made by those skilled in the art without departing from the scope and spirit of this disclosure. Any variation of the various catheters disclosed herein may include features described by any other catheter or combination of catheters herein. Furthermore, any method may be used with any of the disclosed catheters. Therefore, this invention is not intended to be limited to the systems, catheters, and methods described herein, except as provided in the appended claims.

Claims

1. A catheter for treating stenosis in a body cavity, the catheter comprising: Slender components; A housing that is sealed to the distal region of the elongated member and is capable of being filled with fluid; A forward-firing acoustic emitter, the forward-firing acoustic emitter being located on the elongated member, at least partially outside the housing on the distal side of the housing; and A radially fired acoustic emitter, the radially fired acoustic emitter being located on the elongated member, at least partially inside the housing.

2. The conduit of claim 1, wherein the forward-firing acoustic emitter is optically connected to an optical energy source, the optical energy source comprising a laser, and the forward-firing emitter comprising the distal end of an optical fiber.

3. The conduit according to claim 2, wherein the light energy source emits infrared light.

4. The conduit of claim 1, wherein the radially fired acoustic transmitter is electrically connected to a voltage pulse generator and includes an electrode pair.

5. The catheter of claim 4, wherein the first electrode of the electrode pair comprises a conductive surface of a strip, and the second electrode of the electrode pair comprises a conductive portion of an elongated conductive member.

6. The conduit of claim 1, wherein the forward-firing acoustic transmitter is electrically connected to a voltage pulse generator and includes an electrode pair.

7. The conduit according to claim 1, wherein the radially fired acoustic energy emitter is optically connected to a light energy source that emits infrared laser light.

8. The conduit according to claim 1, wherein the conduit comprises a first radially fired acoustic emitter and a second radially fired acoustic emitter.

9. The conduit of claim 8, wherein the first radially fired acoustic transmitter is electrically connected to a voltage pulse generator, and the second radially fired acoustic transmitter is optically connected to a light energy source.

10. The conduit of claim 1, wherein the forward-firing acoustic emitter and the radially-firing acoustic emitter are connected to different types of energy sources.

11. The conduit of claim 1, wherein the forward-firing acoustic emitter and the radially-firing acoustic emitter are connected to a single energy source.

12. The conduit of claim 11, wherein the forward-firing acoustic emitter and the radially-firing acoustic emitter are connected in series.

13. The conduit of claim 11, wherein the forward-firing acoustic emitter and the radially-firing acoustic emitter are connected to a separate channel of the high-voltage generator.

14. A catheter for treating stenosis in a body cavity, the catheter comprising: Slender components; A housing that is sealed to the distal region of the elongated member; A longitudinally movable member, which is at least partially mounted around the elongated member and located inside the housing; A forward-firing acoustic emitter, the forward-firing acoustic emitter being located on the elongated member, at least partially outside the housing at the distal end of the housing; and A radially fired acoustic emitter, the radially fired acoustic emitter being located on the longitudinally movable member, at least partially located inside the housing.

15. The conduit of claim 14, wherein the forward-firing acoustic emitter includes the distal end of an optical fiber extending from a laser source.

16. The conduit of claim 14, wherein the radially fired acoustic emitter includes the distal end of an optical fiber extending from a laser source.

17. The catheter of claim 16, wherein the laser source generates a laser having a wavelength suitable for treating calcified lesions.

18. The catheter of claim 16, wherein the laser source generates a laser with a wavelength suitable for treating tissues softer than calcium.

19. The conduit of claim 14, wherein the housing has a working length of at least 30 mm.

20. A method for treating lesions in blood vessels, the method comprising: The catheter is advanced into the blood vessel until the distal end of the catheter is positioned close to the lesion; Energy is delivered to the distal acoustic emitter of the conduit; Advance the catheter so that the closed radially fired acoustic emitter of the catheter is adjacent to the lesion; Energy is delivered to the enclosed, radially ignited acoustic emitter to generate acoustic energy for further treatment of the lesion; and One or more pressure waves are generated from the closed, radially blasted acoustic emitter.

21. The method of claim 20, wherein the closed radially fired acoustic emitter comprises one of an electrode pair and a distal end of an optical fiber.

22. The method according to claim 20, further comprising: The outer shell of the conduit is expanded prior to the step of delivering energy to the closed radially blasting acoustic emitter; After the step of delivering energy to the closed radially fired acoustic emitter, the radially fired emitter is moved in the longitudinal direction of the conduit; The steps of generating one or more pressure waves from the closed radially fired acoustic emitter are repeated.

23. The method of claim 20, further comprising the step of tuning the acoustic characteristics of the closed radially fired acoustic emitter.

24. A catheter system for treating stenosis in a body cavity, the catheter system comprising: The primary energy source; Second energy source; and The catheter includes: An elongated member configured to be navigated through the body cavity; A first acoustic energy transmitter, the first acoustic energy transmitter being connected to the first energy source and configured to emit acoustic energy when receiving energy from the first energy source; and A second acoustic transmitter is connected to the second energy source and configured to emit acoustic energy when receiving energy from the second energy source.

25. The conduit system of claim 24, wherein the conduit further comprises a housing, and the first acoustic emitter and the second acoustic emitter are enclosed within the housing.

26. The catheter system of claim 24, wherein the first energy source is a voltage pulse generator and the second energy source is a laser source.

27. The catheter system of claim 24, wherein the first energy source is a first voltage pulse generator and the second energy source is a second voltage pulse generator, the second voltage pulse generator being configured to generate voltage pulses having electrical characteristics different from those generated by the first voltage pulse generator.

28. The conduit system of claim 24, wherein neither the first acoustic emitter nor the second acoustic emitter is sealed.

29. The catheter system of claim 24, wherein the first energy source is a first laser source and the second energy source is a second laser source, the second laser source generating light having light energy characteristics different from the light generated by the first laser source.

30. The conduit system of claim 24, further comprising a third energy source, wherein the conduit includes a third acoustic transmitter connected to the third energy source.

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