Intravascular laser lithotripsy catheter

Abstract

An intraluminal device for transmitting pressure waves includes a flexible elongate member configured for positioning within a body lumen. The flexible elongate member includes an outer sheath having a sealed distal end, a reaction chamber, and a sealed acoustic window. The flexible elongate member also includes an optical fiber configured to be coupled to a light source and translate longitudinally within the outer sheath. When the reaction chamber is filled with a photoreactive fluid, the light beam emitted by the optical fiber causes the photoreactive fluid to generate a set of pressure waves that are delivered to a location of the body cavity via the sealed acoustic window. The sealed acoustic window and the sealed distal end prevent photoreactive fluid from entering the body cavity.

Description

Technical Field

[0001] The subject matter described herein relates to systems, devices, and methods for generating shock waves within a patient's body cavity and guiding ablation lasers. The intravascular laser lithotripsy catheter disclosed herein has specific, but not exclusive, efficacy for the rupture of intravascular calcified vascular stenosis. Background Technology

[0002] Many people, especially older adults, suffer from the gradual increase in calcium mineral deposits in their blood vessels. This vascular calcification can lead to impaired vascular integrity, narrowing of blood vessels, high blood pressure, enlarged heart, ischemia, and congestive heart failure. The severity and extent of mineralization are strong predictors of morbidity and mortality. Vascular calcification can be considered in some ways similar to the pathobiological process of bone formation. Vascular calcification (such as arteries and veins) can be a persistent problem when treating coronary or peripheral vascular diseases.

[0003] In many cases, vascular calcification may coexist with other vascular diseases, such as arterial plaques, which can be treated with a combination of laser plaque ablation, balloon angioplasty, and / or stent placement. However, vascular calcification may be rigid enough to resist the expansion of a stent or balloon, making this combination of stenosis difficult to treat.

[0004] The information contained in the background section of this specification (including any references cited herein and any descriptions or discussions thereof) is for technical reference purposes only and should not be considered as a subject matter limiting the scope of this disclosure. Summary of the Invention

[0005] An intravascular laser lithotripsy catheter is disclosed, possessing specific but non-exclusive utility for ablating vascular plaques and rupturing calcified vascular stenosis. The intravascular laser lithotripsy catheter has a shockwave function for radially dissolving calcium without releasing contrast agents or other photoreactive fluids into the patient's body. The intravascular laser lithotripsy catheter includes an optical fiber and a sealed reaction chamber acoustically in communication with the blood volume within the vessel, wherein a photoreaction can occur without releasing photoreactive fluids or their reaction products into the patient's bloodstream. These structures reside within a telescopic catheter comprising a stationary sheath located within the patient's body and a movable portion coupled to the optical fiber and configured to move the optical fiber longitudinally within the sheath.

[0006] One general aspect includes an intraluminal device for transmitting pressure waves. The intraluminal device includes a flexible, elongated member configured for positioning within a body cavity and may include: an outer sheath that may include a sealed distal end, a chamber, and a sealed acoustic window; and an optical fiber configured to be coupled to a light source and longitudinally translated within the outer sheath. When the chamber is filled with a photoreactive fluid, a first light beam emitted from the optical fiber is configured to cause the photoreactive fluid to generate a first set of pressure waves, which are transmitted via the sealed acoustic window to a first location within the body cavity. The sealed acoustic window and the sealed distal end prevent the photoreactive fluid from entering the body cavity.

[0007] Implementations may include one or more of the following features. In some aspects, the optical fiber is configured to be longitudinally translated within the outer sheath, and after the optical fiber has moved to a second position in the body cavity, a second beam emitted by the optical fiber is configured to generate a second set of pressure waves in the photoreactive fluid, the second set of pressure waves being transmitted to the second position in the body cavity via the sealed acoustic window. In some aspects, the first set of pressure waves and the second set of pressure waves are transmitted radially outward from the outer sheath. In some aspects, the sealed acoustic window is disposed radially outward from the chamber. In some aspects, the chamber is disposed distal to the distal end of the optical fiber and proximal to the sealed distal end of the outer sheath. In some aspects, the outer sheath may include a flow-carrying cavity in fluid communication with the chamber, wherein the chamber is configured to be filled with the photoreactive fluid via the flow-carrying cavity. In some aspects, the photoreactive fluid may include an X-ray contrast fluid. In some aspects, the first beam may include ultraviolet light. In some aspects, the intraluminal device may include a radiopaque marker positioned on a distal portion of the outer sheath. In some aspects, the in-lumen device may include a fast-exchange guidewire lumen disposed distal to the sealed distal end of the outer sheath. In some aspects, the in-lumen device may include a reinforcement disposed within at least one of the sealed acoustic window or the outer sheath. In some aspects, the reinforcement may include a coil, braid, or hypotube. In some aspects, the in-lumen device may include multiple optical fibers. In some aspects, the in-lumen device may include: a telescopic internal member coupled to the optical fiber; and a telescopic external member coupled to the outer sheath such that when the telescopic external member is stationary and the telescopic internal member is longitudinally translated relative to the telescopic external member, the optical fiber is longitudinally translated within the outer sheath. In some aspects, the chamber may be a volume within the outer sheath in which the first beam reacts with the photoreactive fluid to generate the first set of pressure waves.

[0008] One general aspect includes an apparatus comprising an intravascular lithotripsy catheter configured to be positioned within a blood vessel and comprising: an outer sheath including a sealed distal end, a reaction chamber, and a sealed acoustic window, the reaction chamber being configured to be filled with a photoreactive fluid; an optical fiber configured to be coupled to a laser source; a telescopic internal component coupled to the optical fiber; and a telescopic external member coupled to the outer sheath, wherein, when the telescopic external member is stationary and the telescopic internal member is longitudinally translated relative to the telescopic external member, the optical fiber is configured to longitudinally translate within the outer sheath from a first longitudinal position and a second longitudinal position, wherein, when the optical fiber is in the first longitudinal position and when the optical fiber is in the second longitudinal position, a laser emitted by the optical fiber is configured to cause the photoreactive fluid to generate a pressure wave, the pressure wave being transmitted to the blood vessel via the sealed acoustic window, wherein the sealed acoustic window and the sealed distal end prevent the photoreactive fluid from entering the blood vessel.

[0009] Implementations of the technology may include hardware, methods or processes, or computer software on a computer-accessible medium.

[0010] A system of one or more computers may be configured to perform specific operations or actions by installing software, firmware, hardware, or a combination thereof on the system, which, in operation, causes the system to perform actions. One or more computer programs may be configured to perform specific operations or actions by including instructions that, when run by a data processing device, cause the device to perform actions. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the method.

[0011] This synopsis is provided to introduce, in a simplified form, a series of concepts further described below in the detailed description. This synopsis is not intended to identify key or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. A broader description of the features, details, efficacy, and advantages of the intravascular laser lithotripsy catheter as defined in the claims is provided in the following written description of various aspects of this disclosure and is illustrated in the accompanying drawings. Attached Figure Description

[0012] The illustrative aspects of this disclosure will be described with reference to the accompanying drawings, in which: Figure 1 This is a schematic diagram of an exemplary endovascular treatment system having an endovascular laser lithotripsy catheter according to at least one aspect of the present disclosure.

[0013] Figure 2 This is a schematic lateral cross-sectional view of at least a portion of an exemplary intravascular laser lithotripsy catheter according to at least one aspect of this disclosure.

[0014] Figure 3A This is a schematic lateral cross-sectional view of at least a portion of an exemplary intravascular laser lithotripsy catheter according to at least one aspect of this disclosure.

[0015] Figure 3B This is a schematic lateral cross-sectional view of at least a portion of an exemplary intravascular laser lithotripsy catheter according to at least one aspect of this disclosure.

[0016] Figure 4 This is a schematic longitudinal sectional view of at least a portion of an exemplary intravascular laser lithotripsy catheter according to at least one aspect of this disclosure.

[0017] Figure 5 This is a schematic side cross-sectional view of at least a portion of a flexible elongated member of an exemplary intravascular laser lithotripsy catheter according to at least one aspect of this disclosure.

[0018] Figure 6 This is a schematic side cross-sectional view of at least a portion of a flexible elongated member of an exemplary intravascular laser lithotripsy catheter according to at least one aspect of this disclosure.

[0019] Figure 7 This is a schematic longitudinal sectional view of at least a portion of an exemplary intravascular laser lithotripsy catheter according to at least one aspect of this disclosure.

[0020] Figure 8 This is a schematic longitudinal sectional view of at least a portion of an exemplary intravascular laser lithotripsy catheter according to at least one aspect of this disclosure.

[0021] Figure 9 This is a schematic longitudinal sectional view of at least a portion of an exemplary intravascular laser lithotripsy catheter according to at least one aspect of this disclosure.

[0022] Figure 10 This is a schematic longitudinal sectional view of at least a portion of an exemplary intravascular laser lithotripsy catheter according to at least one aspect of this disclosure.

[0023] Figure 11 This is a schematic longitudinal sectional view of at least a portion of an exemplary intravascular laser lithotripsy catheter according to at least one aspect of this disclosure.

[0024] Figure 12 A flowchart of an example calcified stenosis rupture method 1100 according to at least one aspect of this disclosure is shown.

[0025] Figure 13 This is a schematic longitudinal sectional view of at least a portion of a blood vessel treated by an exemplary intravascular laser lithotripsy catheter according to at least one aspect of this disclosure.

[0026] Figure 14 This is a schematic longitudinal sectional view of at least a portion of a blood vessel treated by an exemplary intravascular laser lithotripsy catheter according to at least one aspect of this disclosure.

[0027] Figure 15 It is a schematic longitudinal sectional view of at least a portion of a blood vessel after treatment via an intravascular laser lithotripsy catheter, according to at least one aspect of this disclosure.

[0028] Figure 16 It is a schematic longitudinal sectional view of at least a portion of a blood vessel after treatment via an intravascular laser lithotripsy catheter, according to at least one aspect of this disclosure.

[0029] Figure 17 It is a schematic longitudinal sectional view of at least a portion of a blood vessel after treatment by an intravascular laser lithotripsy catheter and a balloon catheter, according to at least one aspect of this disclosure.

[0030] Figure 18 This is a schematic longitudinal sectional view of at least a portion of a blood vessel treated by an exemplary intravascular laser lithotripsy catheter according to at least one aspect of this disclosure.

[0031] Figure 19 This is a schematic longitudinal sectional view of at least a portion of a blood vessel treated by an exemplary intravascular laser lithotripsy catheter according to at least one aspect of this disclosure.

[0032] Figure 20 This is a schematic longitudinal sectional view of at least a portion of a blood vessel treated by an exemplary intravascular laser lithotripsy catheter according to at least one aspect of this disclosure.

[0033] Figure 21 This is a schematic longitudinal sectional view of at least a portion of a blood vessel treated by an exemplary intravascular laser lithotripsy catheter according to at least one aspect of this disclosure.

[0034] Figure 22 It is a schematic diagram of a processor circuit according to at least one aspect of the present disclosure. Detailed Implementation

[0035] Intravascular lithotripsy (IVL) has been used for coronary artery and vascular disease to break down calcium deposits within diseased blood vessels, thus allowing for treatments such as balloon angioplasty and stent placement. IVL involves generating ultrasound waves that, when propagating through hard materials such as large calcium deposits in the vessel wall, create cracks and fissures within the deposits. Ruptling these calcium deposits allows for the application of percutaneous coronary intervention (PCI) procedures, such as balloon angioplasty and stent placement.

[0036] There are several ways to generate ultrasound waves for lithotripsy. One device currently on the market is an angioplasty balloon, which contains electrodes within its inner axis at the balloon's location. Energy is transferred through the electrodes, which generate ultrasound waves (shock waves) that provide the lithotripsy effect when they interact with the medium inside the balloon. Other devices release X-ray contrast fluid into the patient's bloodstream, which can have harmful effects.

[0037] This disclosure describes a laser-based lithotripsy device that addresses issues related to contrast agent exposure and improves the transferability of lithotripsy functionality to desired locations within the vascular system. The technique utilizes a configuration of a sealed intravascular catheter incorporating optical fibers. This configuration of the laser-based lithotripsy device resolves issues related to transferability, laser media containment, and limited-length treatment applications.

[0038] The leading IVL device on the market (manufactured by Shockwave Medical) has several limitations. The distance at which the shockwave can be applied is limited by the length of the balloon on the device. For vessels with long calcified lesions, the balloon needs to be repositioned and re-inflated multiple times to cover the required treatment area. Repositioning the device within the vascular system increases procedure time and the risk of damage to the vascular system. Furthermore, the device's passability (i.e., the ability to navigate the balloon through the vascular system and position it where needed) is limited due to the device's balloon catheter configuration, the volume / stiffness / profile of certain areas of the catheter, and other design factors (potentially also in-line design).

[0039] Other design concepts (some laser-based) address deliverability (via a smaller profile or without a balloon) or treatment application area (via variable positioning of the laser tip), but none adequately address all constraints simultaneously. Concepts incorporating the laser medium typically include a balloon, limiting delivery capability and treatment location. Concepts improving deliverability and flexibility in treatment application distance often involve microcatheter configurations and open sheaths, allowing the laser medium / contrast agent to flow into the vascular system. As described above, this disclosure provides a laser-based lithotripsy device that addresses problems related to exposure to contrast agents, delivery capability, and the (potentially multiple) desired locations for delivering treatment into the vascular system.

[0040] More specifically, this disclosure provides an endovascular laser lithotripsy catheter for use in an endovascular treatment system. The endovascular laser lithotripsy catheter is configured to cause fatigue rupture of vascular calcifications, thus facilitating the dilation of stenosis. Calcifications are often well-rooted in soft tissue, or even completely encapsulated by soft tissue, so that rupture of the calcifications typically does not release calcified material into the bloodstream. The rupture process can be analogous, for example, to breaking a bag of frozen ice without opening the bag.

[0041] This disclosure can, for example, be applied to the treatment of CTO using catheter devices capable of generating shock waves to alter calcium in or around calcified chronic total occlusion (CTO). Calcium damage within and around the total occlusion can hinder typical catheter-based treatments (e.g., balloon dilation or stent placement). Devices such as electrically induced shockwave balloon catheters (e.g., altering calcium by rupture) can be used to enable balloon dilation or stent implantation. However, such electrically induced shockwave balloon catheters may only be effective if access to the stenosis is possible. In the case of calcified CTO, this may be difficult or impossible.

[0042] For example, as described in U.S. Patent US11,058,492, which is incorporated herein by reference, as fully set forth herein, such calcified CTO can be treated with a device capable of penetrating calcified and / or fibrous vascular occlusions (particularly one or more calcified caps) and destroying at least a portion of the vascular occlusion as the device penetrates and passes through the entire occlusion. The device may be able to generate laser-induced pressure waves toward the vascular occlusion to destroy the calcified and / or fibrous portions.

[0043] Lasers can be used to induce an exothermic reaction in photoreactive fluids, which generate shock waves (also known as pressure waves, acoustic waves, acoustic shocks, or hydraulic shocks). These shock waves can rupture calcified tissue embedded in the blood vessel wall without damaging the soft tissue of the vessel wall itself. However, existing systems allow photoreactive fluids (e.g., X-ray contrast fluids) to flow into a patient's vascular system.

[0044] In some aspects, U.S. Patent US11,058,492 (see Figure 33 therein) describes a combination of: first, plaque ablation of a vascular occlusion using a laser catheter distal to a surrounding sheath, followed by pressure wave surgery. In this second procedure, the laser catheter and sheath are positioned such that a pressure wave reflecting element within the sheath is adjacent to the vascular occlusion, and the distal end of the laser catheter is positioned within the pressure wave reflecting element and the sheath. A photoreactive liquid is introduced and the laser is activated to destroy the occlusion. Thus, this reference discloses a laser catheter and sheath wherein, during plaque ablation, the laser extends beyond the end of the sheath, and during pressure wave surgery, the laser catheter is completely within the sheath.

[0045] However, some patients may be allergic to photoreactive liquids or photoreactive products. Even in the absence of allergy, photoreactive liquids or their reaction products may cause undesirable side effects (e.g., in patients with kidney failure or other vulnerabilities). Such side effects may include, but are not limited to, acute kidney injury, exacerbation of chronic kidney disease, or allergic reactions to the material.

[0046] Therefore, this disclosure provides a device with highly localized shock wave capability for cleaving calcium in the radial direction without releasing contrast agents or other photoreactive liquids into the patient.

[0047] In some aspects, the intravascular laser lithotripsy catheter includes a reaction chamber acoustically in communication with the intravascular blood volume, wherein a photoreaction can occur without releasing the photoreactive fluid or its reaction products into the surrounding environment. According to embodiments, the intravascular laser lithotripsy catheter can generate sudden pressure waves (e.g., shock waves) in the blood vessel, or it can generate repetitive shocks, or it can generate time-varying (e.g., sinusoidal) pressure. For example, shock waves may occur when the expansion of a fluid or the movement of an object through a fluid exceeds the local speed of sound of the fluid, resulting in sudden pressure changes or a series of sudden pressure changes.

[0048] This disclosure provides a system comprising an optical fiber (whether single-stranded or multi-stranded), a sheath surrounding the optical fiber and sealing its distal end, a reaction chamber occupying the space between a laser conduit and the sealed distal end, and a flow-carrying cavity surrounding the optical fiber and in fluid communication with the reaction chamber. The liquid in the reaction chamber may be an opaque photoreactive liquid (e.g., an X-ray imaging liquid) capable of generating a shock wave in reaction with a laser. Furthermore, the sheath includes acoustic windows (e.g., one or more portions made of an acoustically transparent polymer or hydrogel, with a sound velocity similar to the surrounding medium) to allow the shock wave to propagate from the interior of the device to the exterior while the liquid remains confined within the reaction chamber. The system can generate a shock wave that can pass radially outward through the acoustic windows of the sheath.

[0049] In some cases, there is a guidewire lumen or rapid exchange port that is in fluid communication with the patient's blood flow, but not with the flow-carrying cavity or reaction chamber.

[0050] Once the endovascular laser lithotripsy catheter is placed within the vessel of interest (e.g., a vessel containing one or more calcified stenosis), the optical fiber can be advanced or retracted within the sheath, thereby moving the distal end of the fiber and the location of the photoreactive fluid without moving the sheath itself. Therefore, the endovascular laser lithotripsy catheter can treat multiple calcified stenosis along a working length of up to 15 cm (although other working lengths, both larger and smaller, can be used alternatively or otherwise) without requiring repeated sheath repositioning. Consequently, lithotripsy can be performed more quickly with a lower risk of vascular injury and without the risk of photoreactive fluid entering the patient's bloodstream compared to current systems. The telescoping capability of the endovascular laser lithotripsy catheter can be related in some respects to the telescoping catheter mechanisms described, for example, in U.S. Patent US10,993,694 and U.S. Patent US10,448,922, each of which is incorporated herein by reference as if fully set forth herein.

[0051] Intravascular laser lithotripsy catheters comprise a laser-based IVL containing laser fibers (or bundles of fibers) and laser material (e.g., X-ray contrast material) housed within a sealed outer tube (e.g., the sealed distal end of the catheter). The laser fibers / bundle are axially translational within the sealed outer tube, allowing the tip to traverse at least, but not limited to, 15 cm within the tube (“telescopic feature”). This feature thus provides flexibility in placing the laser fiber bundle at any or more segments within the length of the sealed outer tube for therapeutic application. The annular space between the laser fibers / bundle can be filled with contrast fluid or other photoreactive media via a filling port at the proximal end of the catheter. The photoreactive fluid is contained within the annular space between the fiber bundle and the outer sheath. The sealed outer sheath serves as a fluid barrier and acoustic window, or may include multiple acoustic windows along its length. The catheter may also have a “rapid-exchange” guidewire port at the distal end of the sealed outer tube segment within the tip of the catheter. This allows the low profile of the distal segment of the catheter to surround the fiber / bundle and the laser medium. In one example, the outer contour of the distal portion of the intravascular laser lithotripsy catheter is approximately 3 French (3 Fr or 1 mm), but alternatively or additionally, other diameters of larger and smaller can be used. This configuration allows for improved delivery capabilities, similar to those of rotating IVUS catheters.

[0052] This disclosure significantly improves the treatment of calcified stenosis by enhancing clinicians' ability to deliver high pressure to calcifications without introducing chemicals into the patient's bloodstream. The endovascular laser lithotripsy catheter disclosed herein provides the practical ability to deliver pressure waves, shock waves, or vibrations to calcified stenosis in acoustic communication with the blood in the vessel without introducing contrast agents or other reactive materials into the patient's bloodstream. In fact, the distal portion of the device can be completely sealed, and repositioning to treat multiple calcified sites within the vessel may not be necessary. This improved endovascular treatment technique transforms solid calcifications into numerous tissue-bound fragments without the need for conventional ablation or cutting of the calcified tissue or interference with the surrounding soft tissue. This unconventional approach enhances the functionality of endovascular treatment systems by allowing pressure waves or shock waves to be delivered from a single sealed device to multiple sites.

[0053] The intravascular laser lithotripsy catheter can be manually controlled or controlled via an automated process that is at least partially viewable on a display and executed on a processor that accepts user input from a keyboard, mouse, touchscreen interface, or other user interface. In this respect, the control process performs certain specific operations in response to different inputs or selections made at different times. Certain structures, functions, and operations of the processor, display, sensors, and user input system are known in the art, while other structures, functions, and operations are described herein to achieve novel features or aspects specific to this disclosure.

[0054] These descriptions are for illustrative purposes only and should not be construed as limiting the scope of intravascular laser lithotripsy catheters. Certain features may be added, removed, or modified without departing from the spirit of the subject matter for which protection is claimed.

[0055] To facilitate understanding of the principles of this disclosure, reference will now be made to the aspects illustrated in the accompanying drawings, and these aspects will be described using specific language. However, it should be understood that this is not intended to limit the scope of this disclosure. Any changes and further modifications to the described apparatus, systems, and methods, as well as any further application of the principles of this disclosure, are fully contemplated and included within this disclosure, as would normally occur to those skilled in the art as per the scope of this disclosure. In particular, it is fully contemplated that features, components, and / or steps described with respect to one aspect may be combined with features, components, and / or steps described with respect to other aspects of this disclosure. However, for the sake of brevity, multiple iterations of these combinations will not be described separately.

[0056] Figure 1 This is a schematic diagram in block form of an exemplary endovascular treatment system 100 having an endovascular laser lithotripsy catheter 102 according to at least one aspect of this disclosure. The endovascular treatment system 100 includes a console or workstation 130 and an endovascular laser lithotripsy catheter 102.

[0057] The unsealed laser-induced pressure wave emitting conduit and sheath console 130 are described, for example, in U.S. Patent 11,058,492 and U.S. Patent 11,246,659, each of which is incorporated herein by reference as fully set forth herein, along with background information relating to the problems addressed by this disclosure. Figure 1 In the example shown, the console 130 includes a housing 135, a display 108 (e.g., a touchscreen display), a user interface 137 (which may include, for example, virtual controls and / or physical knobs, buttons, etc. on the touchscreen display), a processor circuit 106, and a light source 140, such as a UV laser light source emitting in the 100-400 nm range.

[0058] Components displayed within console 130 may be housed in separate enclosures (e.g., different consoles). For example, a separate light source console may exist. The light source console may consist of a enclosure with a light source, processor circuitry, a display, and a user interface for controlling the light source. Console 130 interfaces with an intravascular laser lithotripsy catheter 102 (also known as an intravascular telescopic pressure wave device). Figure 1 In the example shown, the intravascular laser lithotripsy catheter 102 includes a flexible elongated member 115 comprising a guidewire lumen or quick-exchange port 236, an optical fiber 105, and an outer sheath 103. In some aspects, the flexible elongated member is guided by a guidewire 118 through the patient's vascular system. In one example, the guidewire 118 is stationary within the patient's vascular system, and the flexible elongated member 115 slides on the guidewire via the guidewire lumen or quick-exchange port 236 until the distal end of the flexible elongated member reaches the stenosis within the vessel of interest.

[0059] The intravascular laser lithotripsy catheter includes an intravascular pressure wave generating device but has a sealed distal end to prevent the introduction of photoreactive fluid into the patient's bloodstream. The composition and structure of the fiber optic cable 105 and the sheath 103 can be, for example, similar to those described in U.S. Patents US11058492 and US11246659.

[0060] exist Figure 1 In the example shown, the light source 140 communicates optically with the optical fiber 105 via an optical communication line 145 (such as an optical fiber or fiber bundle). Similarly, the pressure wave fluid source 170 (e.g., a syringe) is in fluid communication with the sheath via a fluid channel 180. According to embodiments, the photoreactive pressure wave fluid can be a liquid, a gas, or a combination thereof.

[0061] To provide the benefits of pressure wave generation without requiring precise repositioning of the sheath and without introducing pressure wave fluid or photoreactive fluid into the patient's bloodstream, the intravascular laser lithotripsy catheter 102 is provided with an optical fiber 105 and a sheath 103 that are movable relative to each other. Furthermore, the distal end of the intravascular laser lithotripsy catheter 102 is sealed, allowing the fluids used by the device (e.g., pressure wave fluid) to remain within the distal end of the device (although, according to embodiments, they may drain at or near the proximal end of the sheath).

[0062] In other cases, the fiber optic cable 105 of the intravascular laser lithotripsy catheter 102 can be manually pulled back or advanced by a clinician. In some embodiments, the fiber optic cable 105 can be pulled back within a stationary sheath via a pull-back device 199, which may or may not be under the control of the console 130. The pull-back device 199 is not required. The pull-back device 199 may be a separate accessory attached to a feature on the proximal end of the catheter.

[0063] It should be understood that the block diagrams provided herein are for illustrative purposes; those skilled in the art will recognize numerous variations that still fall within the scope of this disclosure. For example, the block diagrams may illustrate a particular arrangement of components, modules, services, steps, processes, or layers, resulting in specific flows of data, light, fluids, etc. It should be understood that some embodiments of the systems disclosed herein may include additional components, some components shown may be absent in some respects, and the arrangement of components may differ from that shown, resulting in different data flows, while still performing the methods described herein.

[0064] Before proceeding, it should be noted that the examples above are provided for illustrative purposes and are not intended to be restrictive. Other devices and / or device configurations can be used to perform the operations described herein.

[0065] Figure 2 This is a schematic lateral cross-sectional view of at least a portion of an exemplary intravascular laser lithotripsy catheter 102 according to at least one aspect of this disclosure. The intravascular laser lithotripsy catheter 102 includes a proximal connector 210, which serves as an optical fiber 105 and an optional pull-back device 199 (see [link to original text]). Figure 1 The connector for the intravascular laser lithotripsy catheter 102 also includes a photoreactive fluid-filled port or a pressure wave fluid-filled port 230, and a pressure wave fluid source 170 (e.g., a syringe, see...). Figure 1 The photoreactive fluid filling port or the pressure wave fluid filling port can be attached to inject photoreactive fluid into the sheath. The intravascular laser lithotripsy catheter 102 also includes an optical fiber 220, which may include a single fiber or multiple fibers and carries laser energy from the light source 140 (see [link to catheter]). Figure 1The intravascular laser lithotripsy catheter 102 also includes a telescopic inner member 240, which is a flexible, elongated member, such as the catheter surrounding the optical fiber 105. The telescopic inner member 240 is slidably fitted within the lumen of the telescopic outer member 250 such that when the telescopic inner member 240 is retracted, the length L of the intravascular laser lithotripsy catheter 102 increases by a certain amount ΔL. In this example, ΔL can be a working length of up to 150 mm, but other working distances of greater and smaller can be used alternatively or additionally. The sheath 260, the telescopic inner member 240, the telescopic outer member 250, and the optical fiber 105 together form the flexible, elongated member 115.

[0066] The distal end of the telescopic outer member 250 is a sheath 260 through which the optical fiber 105 can be translated when the telescopic inner member 240 is pulled back or pushed forward. The distal portion 270 of the sheath 260 includes one or more acoustic windows, as described below. At the distal end of the sheath 260 is a sealing end 280, which also forms the sealing end of the reaction chamber 290. Distal from the sealing end 290 is a single-rail or high-speed switching track 295, which includes a guidewire lumen or high-speed switching port 236 (see...). Figure 1 ).

[0067] Figure 2 Two longitudinal directions, proximal and distal, are marked. It should be understood that the radial direction relative to the intravascular laser lithotripsy catheter 102 is orthogonal to these longitudinal directions.

[0068] Figure 3A This is a schematic side sectional view of at least a portion of an exemplary intravascular laser lithotripsy catheter 102 according to at least one aspect of this disclosure. A telescopic outer member 250, a telescopic inner member 240, a filling port 230, and an optical fiber 105 are visible in the figure. Figure 3A In the example shown, proximal connector 210 has been replaced by proximal connector 302, which serves only as a connector for fiber optic 105. Connector 302 also provides an additional length 308 of catheter spaced apart from filling port 230, which can be used, for example, to position the device around a workstation and / or patient.

[0069] Figure 3B This is a schematic side sectional view of at least a portion of an exemplary intravascular laser lithotripsy catheter 102 according to at least one aspect of this disclosure. A telescopic outer member 250, a telescopic inner member 240, a filling port 230, and an optical fiber 105 are visible in the figure. Figure 3A In the example shown, the proximal connector 210 has been connected to the proximal connector 304 of the fiber optic cable 105 and the pullback device 199 (see Figure 1The proximal connector 306 is replaced. Connectors 304 and 306 also have an additional length 308 of the catheter spaced apart from the filling port 230, which can be used, for example, to position the device around a workstation and / or patient.

[0070] Figure 4 This is a schematic longitudinal sectional view of at least a portion of an exemplary intravascular laser lithotripsy catheter 102 according to at least one aspect of this disclosure. A flexible, elongated member 115 is visible in the figure, including a sheath 103, an optical fiber 105, a guidewire lumen or quick-exchange port 236, and a flow-carrying cavity 215. The flow-carrying cavity 215 is an annular space within the sheath and surrounding the optical fiber 105, filled with a photoreactive fluid such as an X-ray contrast material.

[0071] The distal portion 310 of the sheath 103 is delivered via a guidewire 118 (in one example, a .014-inch guidewire) to the desired location within the vascular system. An optical fiber 105 is positioned at the desired treatment location within the length of the sheath, and a laser is activated to irradiate a contrast agent and apply treatment at that location. Alternatively, the tip of the laser may be positioned at a desired treatment location and translated when the laser is activated to apply treatment at a desired distance within the closed tube. The distal portion 310 of the sheath 103 includes a sealed end 340. The sheath 103 surrounding the optical fiber 105 includes a flow-carrying cavity 315 that allows fluid to enter the cavity or reaction chamber 320 between the outlet or distal end 350 of the optical fiber 105 and the sealed end 340. When the reaction chamber 320 is filled with a photoreactive fluid (e.g., X-ray contrast fluid), activation of the optical fiber 105 can generate a shock wave (e.g., a pressure wave with highly variable pressure) within the reaction chamber 320. The sheath 103 includes one or more acoustic windows 330 adjacent to the reaction chamber 320. These acoustic windows 330 may be made, for example, of an acoustically permeable material (such as Pebax, polyethylene, etc.) to allow the shock wave to pass through while preventing bubbles, photoreactive fluids, or reaction products from leaving the flexible elongated member 115. The acoustic window 330 extends along the sheath 103 by a distance DW, which in some cases can be the entire length of the sheath 130 or the entire working distance ΔL of the intravascular laser lithotripsy catheter 102, but may also be a shorter distance, depending on the specific implementation.

[0072] As a result, when the photoreactive fluid is within the cavity, the system functions as a shock wave generating device. For this purpose, mechanical movement of the laser fiber 105 relative to the sheath 103 is unnecessary. However, translation (e.g., pull-back) of the laser fiber 105 within the sheath 103 allows for treatment over a larger area or multiple areas without any movement of the sheath itself. To prevent blood from entering the sheath 103, the distal portion 310 of the sheath 103 is sealed by an acoustic window 330 and a sealing end 340. Therefore, the fluid is completely sealed within the volume within the sheath 103 (e.g., within the flow-carrying cavity 315 and the reaction chamber 320). No fluid enters the surrounding environment (e.g., blood vessels, blood within blood vessels). This is advantageous because some patients may have adverse reactions to fluids such as radiopaque contrast agents.

[0073] In some respects, the radiopaque marker 370 can be used to mark the position of the monorail or rapid-change track 295 so that its position can be seen on X-ray fluoroscopy. In one example, the radiopaque marker 370 is separated from the distal end of the acoustic window by a known distance DRW, which helps the user (e.g., a vascular surgeon) to align the acoustic window with calcified stenosis, as described below.

[0074] To operate within the patient's tortuous vascular system and to navigate through narrowings (especially calcified stenosis), it is desirable that the outer diameter OD of the sheath 103 be as small as possible. In the example, OD is between 0.66 mm and 1.33 mm, but other larger and smaller values ​​may be used alternatively or additionally. The diameter DL of the laser fiber 105 should be large enough to carry sufficient laser energy to perform the lithotripsy portion of the procedure, while still leaving enough space in the flow-carrying cavity 215 to transfer the photoreactive fluid to the reaction chamber 320. In one example, the diameter of the laser fiber is between 50 micrometers and 1000 micrometers.

[0075] Figure 5 This is a schematic side cross-sectional view of at least a portion of the flexible elongated member 115 of an exemplary intravascular laser lithotripsy catheter 102 according to at least one aspect of this disclosure. The sheath 103, optical fiber 105, and flow-carrying cavity 215 are visible in the figure. Figure 5 In the example shown, optical fiber 105 comprises a single optical fiber core 205 (e.g., made of silica), an outer cladding 510 (e.g., also silica), and an outer polymer 520. In some cases, core 205, cladding 510, and polymer 520 (or optical fiber 105) may be collectively referred to as an optical fiber cable. Optical fiber 105 is surrounded by a current-carrying cavity 215 of sheath 103. During the pressure wave generation portion of the procedure, the current-carrying cavity is filled with a photoreactive pressure wave fluid (e.g., X-ray contrast fluid or other photoreactive fluid) from pressure wave fluid source 170, which can be used to generate a shock wave, as described below.

[0076] Figure 6 This is a schematic side cross-sectional view of at least a portion of the flexible elongated member 115 of an exemplary intravascular laser lithotripsy catheter 102 according to at least one aspect of this disclosure. The sheath 103, optical fiber 105, and flow-carrying cavity 215 are visible in the figure. Figure 5 In the example shown, optical fiber 105 comprises multiple fiber cores 205 (e.g., made of silica, with an outer silica cladding and a polymer outer layer). Optical fiber 105 is surrounded by a current-carrying cavity 215 of sheath 103. During the pressure wave generation portion of the procedure, the current-carrying cavity is filled with a photoreactive pressure wave fluid (e.g., X-ray contrast fluid or other photoreactive fluid) from a pressure wave fluid source 170, which can be used to generate a shock wave, as described below.

[0077] Figure 7 This is a schematic longitudinal sectional view of at least a portion of an exemplary intravascular laser lithotripsy catheter 102 according to at least one aspect of this disclosure. The sheath 103, optical fiber 105, sealing end 340, flow-carrying cavity 215, reaction chamber 320, and acoustic window 330 are visible in the figure. The cavity or reaction chamber 320 may be a volume within the outer sheath 103 in which a reaction occurs between light emitted by the optical fiber 105 and a photoreactive fluid 410 to generate a pressure wave 440.

[0078] exist Figure 7 In the example shown, the flow-carrying cavity 215 and the reaction chamber 320 are filled with a photoreactive liquid or pressure wave fluid 410. In a non-limiting example, some X-ray contrast fluids (such as Ioversol, Ixilan, or other commercially available iodine-containing injectable X-ray contrast agents) produce an exothermic reaction when irradiated with ultraviolet light, and therefore can be used as the photoreactive liquid 410. Thus, when the fiber optic cable 105 emits a laser 420 into the photoreactive liquid 410, the laser generates a chemical or physical reaction 430, which can generate a shock wave or pressure wave 440, for example, by producing rapidly expanding bubbles. The shock wave or pressure wave 440 can then enter the external environment (e.g., blood moving within a blood vessel) from the reaction chamber 320 through the acoustic window 330. Note that in Figure 7 In the example shown, the shock wave or pressure wave 440 is emitted laterally in the radial direction relative to the sheath 103. Depending on the configuration of the acoustic window 330, the shock wave or pressure wave can be emitted only on one side, on one side and the other (whether opposite or otherwise), through an annular ring completely surrounding the sheath 103, or a combination thereof. The laser 420 can be a single pulse or beam (e.g., a continuous pulse / beam) or a series of pulses or beams (e.g., multiple individual pulses / beams). In some cases, the pressure wave 440 is generated by a portion of the light emitted by the optical fiber 105.

[0079] Examples of contrast fluids can be found in U.S. Patent 11058492 and U.S. Patent 11246659.

[0080] Figure 8 This is a schematic longitudinal sectional view of at least a portion of an exemplary intravascular laser lithotripsy catheter 102 according to at least one aspect of this disclosure. The sheath 103, optical fiber 105, sealing end 340, flow-carrying cavity 215, reaction chamber 320, and acoustic window 330 are visible in the figure. Figure 8 In the example shown, the acoustic window 330 includes a reinforcement 810. The reinforcement 810 may include, for example, a coil, braid, laser-cut hyaluronic acid tube, or other structures embedded in the polymer of the acoustic window to increase mechanical strength. This may be necessary, for example, when the mechanical strength of the acoustically transparent polymer of the acoustic window 330 is lower than that of the polymer(s) used to manufacture other parts of the sheath 103, and / or because the shock wave generated by the laser exerts high mechanical stress on the acoustic window 330.

[0081] Figure 9 This is a schematic longitudinal sectional view of at least a portion of an exemplary intravascular laser lithotripsy catheter 102 according to at least one aspect of this disclosure. The sheath 103, optical fiber 105, sealing end 340, flow-carrying cavity 215, reaction chamber 320, and acoustic window 330 are visible in the figure. Figure 9 Similar to Figure 8 However, in Figure 9 In the example shown, the acoustic reinforcement 810 extends not only through the polymer of the acoustic window 330, but also through the polymer of the sheath 103. This may be necessary, for example, where it is necessary to enhance the mechanical strength of the sheath 103 (including the acoustic window 330).

[0082] Figure 10 This is a schematic longitudinal sectional view of at least a portion of an exemplary intravascular laser lithotripsy catheter 102 according to at least one aspect of this disclosure. A telescopic internal component 240, a telescopic external component 250, a sheath 103, and an optical fiber 105, including its laser-emitting distal end 350, are visible in the figure.

[0083] The intravascular laser lithotripsy catheter 102 is formed of a first portion or telescopic portion 4 and a second portion 5. The telescopic portion 4 is operatively associated with a proximal housing 1009, which may include, for example, […]. Figure 2The filling port 230 and connector 210 are included. The proximal housing 1009 can be manually translated or coupled to a system that facilitates the movement of the proximal housing 1009 (such as a pull-back device). The optical fiber 105 terminates at the transmitting distal end 350. As will be understood, depending on the intended use of the catheter, the transmitting distal end 350 may include an optical lens or a reflector. When the optical fiber 105 is translated within the sheath or catheter body 103, the transmitting distal end 350 can generate a calcium rupture shock wave along the length of a body cavity (e.g., a blood vessel).

[0084] The sheath or catheter body 103 includes a distal portion 5 and a proximal portion 3. The distal portion 5 is the part of the sheath or catheter body 103 that is not located within the telescopic segment 4. The distal portion 5 is the part of the sheath or catheter body 103 that is introduced into the patient's body. The proximal portion 3 of the sheath or catheter body 103 is the portion that extends into the telescopic portion 4 of the intravascular laser lithotripsy catheter 102. Therefore, the sheath or catheter body 103 extends over the optical fiber 105 within the telescopic portion 4, such that the sheath or catheter body 103 provides additional support for the optical fiber 105. The sheath or catheter body 103 may be formed from a single material or multiple materials. Furthermore, the sheath or catheter body 103 may be segmented (e.g., having variable flexibility along its length). For example, the proximal portion 3 of the sheath or catheter body 103 within the telescopic portion 4 may be more rigid than the distal portion 5 of the sheath or catheter body 103. According to embodiments, the distal portion 5 of the sheath or catheter body 103 may itself have a rigid proximal portion and a more flexible distal portion 310. Catheter bodies with variable thickness are described in more detail in U.S. Publication No. US2009 / 0018393, which is incorporated herein by reference as if fully set forth herein.

[0085] The telescopic section 4 includes an outer telescopic member 250, an inner telescopic member 240 that slides into the outer telescopic member 250, and an anchoring housing unit 1010 with an optional fluid seal 1020. Although the telescopic members 240 and 250 are described as tubular, it should be understood that these members can have other shapes. The outer telescopic member 250 can be coupled to the sheath or conduit body 103 via a conduit coupler 1030. The anchoring housing unit 1010 is coupled to the outer telescopic member 250 and the sheath or conduit body 103. The anchoring housing unit 1010 can be held in a fixed position manually or by a system (e.g., a pull-back device), thereby also maintaining the positioning of the outer telescopic member 250 and the sheath or conduit body 103. The inner telescopic member 240 and the fiber optic cable 105 are operatively associated with the proximal housing such that translation of the proximal housing 1009 causes the inner telescopic member 240 and the fiber optic cable 105 to translate in the same way.

[0086] The proximal housing 1009 can also be associated with a system (such as a pull-back device) that translates the proximal housing, the internal telescopic member 240, and the optical fiber 105. It is important to note that the optical fiber 105 has a fixed length such that when the internal telescopic member 240 of the telescopic section 4 translates relative to the external telescopic member 250 and the sheath or conduit body 103, the laser-emitting distal end 350 of the optical fiber 105 also translates.

[0087] In addition to the optical fiber 105, the external telescopic member 250 is configured to receive the internal telescopic member 240 and the sheath or catheter body 103. The internal telescopic member 240 is configured to receive the sheath or catheter body 103 and the optical fiber 105. That is, the internal telescopic member 240 is sized to fit the outer diameter of the proximal portion 3 of the sheath or catheter body 103. These configurations allow the internal telescopic member 240 and the optical fiber 105 to be slidably translated relative to the external telescopic member 250 and the sheath or catheter body 103.

[0088] Figure 10 and Figure 11 The translation of the telescopic portion 104 during treatment pull-back is shown. Treatment pull-back is the translation of the laser-emitting distal end 350 of the fiber optic cable 105 within the length of the sheathed catheter body 103. During pull-back, the laser-emitting distal end 350 is capable of generating a shock wave along the length of the blood vessel containing the catheter.

[0089] Figure 10 An intravascular laser lithotripsy catheter 102 in its fully unextended position is shown. In the fully unextended position, the outer telescopic member 250, the inner telescopic member 240, and the proximal portion 3 of the sheath or catheter body 103 are substantially concentrically aligned. When in the fully unextended position, the distal emitting end 350 of the fiber optic cable 105 is located distal to the sheath or catheter body 103. Typically, when the distal emitting end 350 is at the distal portion 310 of the sheath or catheter body 103, a shock wave generation lithotripsy procedure is initiated, and then the imaging transducer is pulled back (proximal) within the catheter body to generate a shock wave along the length of the sheath 103, causing the telescopic portion 4 to transition from the unextended position to the extended position. To transition to the extended position, the inner telescopic member 240 and the fiber optic cable 105 move proximal to relative to the sheath or catheter body 103 and the outer telescopic member 250.

[0090] Figure 11 This is a schematic longitudinal sectional view of at least a portion of an exemplary intravascular laser lithotripsy catheter 102 according to at least one aspect of this disclosure. A telescopic internal component 240, a telescopic external component 250, a sheath 103, and an optical fiber 105, including its laser-emitting distal end 350, are visible in the figure. Anchoring housing unit 1010, a fluid seal 1020, a proximal housing 1009, and a catheter coupling 1030 are also visible.

[0091] Figure 11 An intravascular laser lithotripsy catheter 102 in its fully extended position is shown. Figure 11 As shown, the internal telescopic member 240, fiber optic cable 105, and proximal housing 1009 have been moved by a length L in the distal direction. In this example, L can be up to 15 cm, but other working lengths of greater and smaller can be used alternatively or additionally. Meanwhile, the external telescopic member 250, anchoring housing 1010, and sheath or catheter body 103 maintain their position within the patient's body. This allows the distal emitting end 350 of the fiber optic cable 105 to also translate a distance L within the sheath or catheter body 103.

[0092] In the example, the length of the distal portion 5 of the endovascular laser lithotripsy catheter 102 can range from 125 cm to 200 cm, but alternatively or additionally, larger and smaller lengths can be used. As an alternative to pull-back treatment, the endovascular laser lithotripsy catheter 102 is also configured to use forward push treatment. For this imaging, the telescopic portion 4 of the catheter 100 transitions from an extended position to an unextended position. In some embodiments, such as Figure 4 As shown, the internal telescopic member 240 may include a stop 1033 for stopping proximal translation of the internal telescopic member 240 at a certain point. For example, the stop 1033 may be configured to prevent the internal telescopic member 240 from leaving the proximal end of the telescopic external member 250.

[0093] In other cases, the telescopic internal component 240 can be manually pulled back or pushed forward by a clinician. In some embodiments, the telescopic internal component 240 can be pulled back within a stationary sheath via a pull-back device 199, which may or may not be under the control of the console 130.

[0094] Figure 12 A flowchart of an example method 1100 for rupture of calcified stenosis according to at least one aspect of this disclosure is shown. It should be understood that the steps of method 1100 can be combined with... Figure 12 The different sequences of execution shown may provide additional steps before, during, and after the steps, and / or may otherwise replace or eliminate some of the described steps. One or more steps of method 1100 may be performed at least in part by one or more devices and / or systems described herein (such as components of endovascular treatment system 100, processor circuitry 106, and / or processor circuitry 2250).

[0095] In step 1110, method 1100 includes inserting a guidewire into the target blood vessel and advancing or passing through the target stenosis.

[0096] In step 1115, method 1100 includes inserting an intravascular laser lithotripsy catheter through a guidewire into the target blood vessel and advancing it until it approaches the calcified stenosis at a first position.

[0097] In step 1120, method 1100 includes using a pressure wave fluid source to supply pressure wave fluid (such as a photoreactive liquid or X-ray imaging fluid) to a distal portion of the sheath through a flow-carrying cavity.

[0098] In step 1125, method 1100 includes controlling a light source to provide light (e.g., ultraviolet laser) to an optical fiber.

[0099] In step 1130, method 1100 includes emitting shock waves or pressure waves into the vessel wall. These shock waves are the result of the interaction between a laser and a pressure-wave fluid or photoreactive fluid, and are transmitted laterally / radially from the sheath through an acoustic window. Shock waves or pressure waves can be used to rupture calcifications embedded in the vessel wall.

[0100] In step 1135, method 1100 includes moving an optical fiber within the flow-carrying cavity of the sealing sheath or catheter while the sheath or catheter remains stationary within the blood vessel. The optical fiber can be repositioned within the sheath to align it with the unruptured calcified vascular tissue in a second location.

[0101] In step 1140, method 1100 controls the light source to provide light (e.g., UV laser) to the laser conduit.

[0102] In step 1145, method 1100 includes emitting shock waves or pressure waves into the vessel wall. These shock waves are the result of the interaction between a laser and a pressure-wave fluid or photoreactive fluid, and are transmitted laterally / radially from the sheath through an acoustic window. The shock waves or pressure waves can be used to treat calcifications embedded in the vessel wall at a ruptured second location.

[0103] In step 1150, method 1100 includes removing an intravascular laser lithotripsy catheter from a blood vessel by moving the guidewire in the opposite direction (relative to the direction of movement in step 1110) over the guidewire.

[0104] In step 1155, method 1100 includes inserting an additional treatment device (one or more) onto a guidewire to a blood vessel. Such an additional treatment device may include, for example, a balloon catheter or a stent.

[0105] In step 1170, method 1100 includes performing additional treatment using one or more additional treatment devices. Such additional treatment may include, for example, balloon angioplasty and / or stent placement to dilate the blood vessel at the ruptured calcification site.

[0106] In step 1165, method 1100 includes removing one or more additional treatment devices and guidewires from the blood vessel. The method is now complete.

[0107] It should be noted that steps 1125 and 1140 are or can be performed by console 130 (see [link]). Figure 1 The steps 1110, 1115, 1120, 1130, 1135, 1145, 1150, 1155, 1160 and 1165 are either the result of the automatic steps or, at least in part, manual steps performed by the clinician operating the endovascular treatment system 100 and the endovascular laser lithotripsy catheter 102.

[0108] Note that the flowcharts provided herein are for illustrative purposes only; those skilled in the art will recognize that numerous variations still fall within the scope of this disclosure. For example, the logic of the flowcharts may be shown sequentially. However, similar logic may be parallel, massively parallel, object-oriented, real-time, event-driven, cellular automata, or otherwise, while implementing the same or similar functionality. To perform the methods described herein, a processor may divide one or more steps described herein into a plurality of machine instructions, and may execute these instructions in a single processor or across multiple processors at a rate of hundreds, thousands, millions, or billions per second.

[0109] Figure 13 This is a schematic longitudinal sectional view of at least a portion of a blood vessel 1200 treated by an exemplary intravascular laser lithotripsy catheter 102 according to at least one aspect of this disclosure. The figure shows a flexible elongated member 115, a guidewire 118, a photoreactive fluid 410, a reaction chamber 320, an optical fiber 105, an acoustic window 330, and a calcification 1260. Figure 13 In the example shown, the intravascular laser lithotripsy catheter 102 emits shock waves or pressure waves 440 radially toward the vessel wall 1210. These shock waves or pressure waves 440 can rupture calcifications 1260 embedded in the soft tissue of the vessel wall 1210 without damaging the soft tissue of the vessel wall 1210.

[0110] Figure 14 This is a schematic longitudinal sectional view of at least a portion of a blood vessel 1200 treated via an exemplary intravascular laser lithotripsy catheter 102 according to at least one aspect of this disclosure. The figure shows a flexible elongated member 115, a guidewire 118, a photoreactive fluid 410, a reaction chamber 320, an optical fiber 105, an acoustic window 330, and calcification 1260. Figure 14In the example shown, when fiber 105 is pulled back (e.g., pulled proximally) through the stenosis, solid calcification 1260 has been partially converted into ruptured calcification 1460 by the shock wave or pressure wave 440. Solid calcification 1260 typically resists expansion by balloon catheters or stents. However, ruptured calcification 1560 tends to be well preserved by the soft tissue of the vessel wall but is still capable of expansion.

[0111] Figure 15 This is a schematic longitudinal sectional view of at least a portion of a blood vessel 1200 after treatment via an intravascular laser lithotripsy catheter, according to at least one aspect of this disclosure. The vessel wall 1210, lumen 1220, and normal diameter D are visible in the figure. 正常 After treatment via an intravascular laser lithotripsy catheter, the stenosis was 1240 mm in diameter (D). 处置 Now less than D 正常 .

[0112] Figure 16 This is a schematic longitudinal sectional view of at least a portion of a blood vessel 1200 after treatment via an intravascular laser lithotripsy catheter, according to at least one aspect of this disclosure. Figure 16 In the example shown, balloon catheter 1620 has been advanced along the guidewire and then inserted into stenosis 1240 to dilate vessel 1200 at the location of stenosis 1240. Since the solid calcification has been converted into ruptured calcification 1560, stenosis 1240 can now be dilated / expanded by a treatment device such as balloon catheter 1620.

[0113] Figure 17 This is a schematic longitudinal sectional view of at least a portion of a blood vessel 1200 after treatment with an intravascular laser lithotripsy catheter and a balloon catheter, according to at least one aspect of this disclosure. Following treatment with the balloon catheter, the stenosis 1240 has dilated to a diameter D. 扩张 It is larger than the diameter D 处置 (see Figure 15 ), and can be equal to or equivalent to D 正常 In some cases, the stenosis can now be treated. In others, a stent may be placed, or other interventions may be performed to ensure the blood vessel maintains a healthy diameter.

[0114] Figure 18 This is a schematic longitudinal sectional view of at least a portion of a blood vessel 1200 treated via an exemplary intravascular laser lithotripsy catheter 102 according to at least one aspect of this disclosure. The figure shows a flexible elongated member 115, a guidewire 118, a photoreactive fluid 410, a reaction chamber 320, an optical fiber 105, an acoustic window 330, and multiple calcifications 1260. Figure 18In the example shown, the intravascular laser lithotripsy catheter 102 emits a shock wave or pressure wave 440 toward the vessel wall 1210 in the radial direction.

[0115] Figure 19 This is a schematic longitudinal sectional view of at least a portion of a blood vessel 1200 treated via an exemplary intravascular laser lithotripsy catheter 102 according to at least one aspect of this disclosure. The figure shows a flexible elongated member 115, a guidewire 118, a photoreactive fluid 410, a reaction chamber 320, an optical fiber 105, an acoustic window 330, and calcification 1260. Figure 19 In the example shown, as the fiber 105 is pulled back (e.g., pulled in the proximal direction 1270) through the narrow passage, the first region of the solid calcification 1260 has been converted into ruptured calcification 1460 by the shock wave or pressure wave 440. The fiber 105 is now further pulled in the proximal direction 1270 toward the untreated region of the solid calcification 1260.

[0116] Figure 20 This is a schematic longitudinal sectional view of at least a portion of a blood vessel 1200 treated via an exemplary intravascular laser lithotripsy catheter 102 according to at least one aspect of this disclosure. The figure shows a flexible elongated member 115, a guidewire 118, a photoreactive fluid 410, a reaction chamber 320, an optical fiber 105, an acoustic window 330, ruptured calcification 1460, and solid calcification 1260. Figure 20 In the example shown, the intravascular laser lithotripsy catheter 102 emits a shock wave or pressure wave 440 in the radial direction toward the vessel wall 1210 at the location of the untreated solid calcification 1260, while being pulled backward in the proximal direction 1270.

[0117] Figure 21 This is a schematic longitudinal sectional view of at least a portion of a blood vessel 1200 treated via an exemplary intravascular laser lithotripsy catheter 102 according to at least one aspect of this disclosure. The figure shows a flexible elongated member 115, a guidewire 118, a photoreactive fluid 410, a reaction chamber 320, an optical fiber 105, an acoustic window 330, and a ruptured calcification 1460. Figure 21 In the example shown, as the fiber 105 is pulled back (e.g., pulled proximally 1270) through the stenosis, the two areas of solid calcification have now been converted into ruptured calcification 1460 by the shock wave or pressure wave 440. If needed, the fiber 105 can now be further pulled proximally 1270 to treat additional areas of solid calcification 1260, or if the lithotripsy portion of the procedure is completed, the entire intravascular laser lithotripsy catheter 102 can be removed from the patient.

[0118] In some respects, when optical fibers move (e.g., from...) Figure 13 Move to the position shownFigure 14 When positioned as shown, the intravascular laser lithotripsy catheter can emit a single pulse or beam (e.g., continuous pulse / beam) or a series of pulses or beams (e.g., multiple individual pulses / beams). In some aspects, the intravascular laser lithotripsy catheter can be positioned at discrete locations (e.g., Figure 18 The location shown Figure 20 When the position shown is reached, a pulse or beam (e.g., a continuous pulse / beam) or a series of pulses or beams (e.g., multiple individual pulses / beams) is emitted.

[0119] Shock waves or pressure waves 440 are generated based on light emitted from optical fibers. The light emitted by an optical fiber at a given location can be referred to as one or more beams or pulses. For example, the first beam could be light emitted by an optical fiber to... Figure 13 or Figure 18 The location shown induces a shock wave or pressure wave 440. For example, the second beam could be a portion of the light emitted by an optical fiber, to... Figure 14 or Figure 20 The location shown causes a shock wave or pressure wave 440. Typically, (one or more) beams or pulses of light can refer to portions of light emitted by an optical fiber, for example, at a given location or at a given time, whether emitting a continuous pulse / beam or emitting multiple individual pulses / beams.

[0120] Figure 22 This is a schematic diagram of processor circuitry 2250 according to at least one aspect of this disclosure. Processor circuitry 2250 can be implemented as needed in the intravascular treatment system 100, console 130, or other devices or workstations (e.g., third-party workstations, network routers, etc.), or on a cloud processor or other remote processing unit to implement the method. As shown, processor circuitry 2250 may include processor 2260, memory 2264, and communication module 2268. These components can communicate directly or indirectly with each other, for example, via one or more buses.

[0121] Processor 2260 may include any combination of a central processing unit (CPU), digital signal processor (DSP), ASIC, controller or general-purpose computing device, reduced instruction set computing (RISC) device, application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), or other related logic devices (including mechanical and quantum computers). Processor 2260 may also include another hardware device, firmware device, or any combination thereof configured to perform the operations described herein. Processor 2260 may also be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors combined with a DSP core, or any other such configuration.

[0122] Memory 2264 may include cache memory (e.g., the cache memory of processor 2260), random access memory (RAM), magnetoresistive RAM (MRAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, solid-state memory devices, hard disk drives, other forms of volatile and non-volatile memory, or combinations of different types of memory. In one aspect, memory 2264 includes a non-transitory computer-readable medium. Memory 2264 may store instructions 2266. Instructions 2266 may include instructions that, when executed by processor 2260, cause processor 2260 to perform the operations described herein. Instructions 2266 may also be referred to as code. The terms “instruction” and “code” should be interpreted broadly to include any type of computer-readable statement(s). For example, the terms “instruction” and “code” may refer to one or more programs, routines, subroutines, functions, procedures, etc., and “instruction” and “code” may include a single computer-readable statement or a number of computer-readable statements.

[0123] Communication module 2268 may include any electronic circuitry and / or logic circuitry to facilitate direct or indirect data communication between processor circuitry 2250 and other processors or devices. In this regard, communication module 2268 may be an input / output (I / O) device. In some cases, communication module 2268 facilitates direct or indirect communication between processor circuitry 2250 and / or various components of system 100. Communication module 2268 can communicate within processor circuitry 2250 via a variety of methods or protocols. Serial communication protocols may include, but are not limited to, US Serial Protocol Interface (US SPI), Internal Integrated Circuit (I2C), RS-232, RS-485, Controller Area Network (CAN), Ethernet, ARINC 429, MODBUS, MIL-STD-1553, or any other suitable method or protocol. Parallel protocols include, but are not limited to, Industry Standard Architecture (ISA), Advanced Technology Annex (ATA), Small Computer System Interface (SCSI), Peripheral Component Interconnect (PCI), Institute of Electrical and Electronics Engineers 488 (IEEE-488), IEEE-1284, and other suitable protocols. Where appropriate, serial and parallel communication can be bridged via Universal Asynchronous Receiver Transmitter (UART), Universal Synchronous Receiver Transmitter (USART), or other suitable subsystems.

[0124] External communication (including but not limited to software updates, firmware updates, preset sharing between the processor and the central server, or readings from the pressure gauge) can be implemented using any suitable wireless or wired communication technology, such as cable interfaces (e.g., Universal Serial Bus (USB), Micro USB, Lightning, or FireWire interfaces), Bluetooth, Wi-Fi, ZigBee, Li-Fi, or cellular data connections (e.g., 2G / GSM (Global System for Mobile Communications), 3G / UMTS (Universal Mobile Telecommunications System), 4G, LTE, WiMax, or 5G). For example, Bluetooth Low Energy (BLE) radios can be used to establish connections to cloud services, transmit data, and receive software patches. The controller can be configured to communicate with remote servers or local devices such as laptops, tablets, or handheld devices, or may include a display capable of showing status variables and other information. Information can also be transmitted on physical media such as USB flash drives or memory sticks.

[0125] As will be readily understood by those skilled in the art upon familiarity with the teachings herein, endovascular laser lithotripsy catheters advantageously provide the ability to perform both laser plaque ablation and rupture calcified vascular stenosis (including stenosis in peripheral and coronary veins and arteries) without requiring movement of the laser catheter relative to its surrounding sheath and without introducing photoreactive materials, bubbles, or other reaction products (e.g., carbon monoxide, carbon dioxide, methane, water vapor, etc.) into the patient's bloodstream. Endovascular laser lithotripsy catheters can be used in cardiovascular surgery to treat chronic total occlusion (CTO) with moderate to severe calcification.

[0126] In some aspects, the optical fiber of the intravascular laser lithotripsy catheter can be detected through the acoustic window.

[0127] Many variations are possible with respect to the examples and aspects described above. For example, endovascular laser lithotripsy catheters can be used not only in arteries but also in veins and other body cavities, including but not limited to the liver, kidneys, stomach, gallbladder, lymphatic system, or others. Without departing from the spirit of this disclosure, the system may employ other types of lenses, light sources, or fluids besides those described herein. Endovascular laser lithotripsy catheters can be used in other body cavities where there is clinical benefit in shock waves, pressure waves, or vibrations.

[0128] Therefore, the logical operations constituting the aspects of the technology described herein are referred to differently as operations, steps, objects, elements, components, or modules. Furthermore, it should be understood that these can occur, be performed, or be arranged in any order unless otherwise expressly required or the language of the claims inherently necessitates a specific order.

[0129] All directional references, such as up, down, inside, outside, upward, downward, left, right, lateral, front, back, top, bottom, above, below, vertical, horizontal, clockwise, counterclockwise, proximal, and distal, are used for identification purposes only to help the reader understand the claimed subject matter and do not constitute a limitation, particularly concerning the location, orientation, or use of intravascular laser lithotripsy catheters. Unless otherwise stated, connection references (e.g., attachment, coupling, connection, engagement, or “connection”) should be interpreted broadly and may include intermediate members between sets of elements and relative movement between elements. Therefore, a connection reference does not necessarily mean that two elements are directly connected and fixed to each other. The term “or” should be interpreted as “and / or”, not “exclusive or”. The word “comprising” does not exclude other elements or steps, and the quantifiers “a” or “an” do not exclude a plurality. Unless otherwise stated in the claims, the values ​​stated should be interpreted only as illustrative and not as limiting.

[0130] The foregoing specification, examples, and data provide a complete description of the structure and use of exemplary aspects of the intravascular laser lithotripsy catheter as defined in the claims. Although various aspects of the claimed subject matter have been described above with a degree of specificity or by reference to one or more individual aspects, many changes can be made to the disclosed aspects by those skilled in the art without departing from the spirit or scope of the claimed subject matter. Other aspects are also contemplated. It is intended that everything contained in the foregoing description and shown in the accompanying drawings should be interpreted as illustrative of specific aspects only and not as limiting. Changes in detail or structure may be made without departing from the essential elements of the subject matter as defined in the claims.

Claims

1. An intracavitary device for transmitting pressure waves, the device comprising: A flexible, elongated member configured for positioning within a body cavity and comprising: An outer sheath, comprising a sealed distal end, a chamber, and a sealed acoustic window; and An optical fiber, configured to be coupled to a light source and longitudinally translated within the outer sheath; When the chamber is filled with a photoreactive fluid, a first light beam emitted by the optical fiber is configured to cause the photoreactive fluid to generate a first set of pressure waves. These pressure waves are transmitted to a first location within the body cavity via the sealed acoustic window. The sealed acoustic window and the sealed distal end prevent the photoreactive fluid from entering the body cavity.

2. The intra-cavity device according to claim 1, wherein, After the optical fiber moves to the second position in the body cavity, the second beam emitted by the optical fiber is configured to cause the photoreactive fluid to generate a second set of pressure waves, which are transmitted to the second position in the body cavity via the sealed acoustic window.

3. The intra-cavity device according to claim 2, wherein, The first set of pressure waves and the second set of pressure waves are transmitted radially outward from the outer sheath.

4. The intra-cavity device according to claim 1, wherein, The sealed acoustic window is arranged radially outward from the chamber.

5. The intra-cavity device according to claim 1, wherein, The chamber is located on the distal side of the distal end of the optical fiber and on the proximal side of the sealed distal end of the outer sheath.

6. The intra-cavity device according to claim 1, in, The outer sheath includes a flow-carrying cavity in fluid communication with the chamber, and The chamber is configured to be filled with the photoreactive fluid via the flow-carrying cavity.

7. The intra-cavity device according to claim 1, wherein, The photoreactive fluid includes X-ray imaging fluid.

8. The intra-cavity device according to claim 1, wherein, The first beam includes ultraviolet light.

9. The intraluminal device of claim 1, further comprising a radiopaque marking located on the distal portion of the outer sheath.

10. The intraluminal device according to claim 1, further comprising a rapid exchange guidewire lumen disposed distal to the sealed distal end of the outer sheath.

11. The intracavitary device according to claim 1, further comprising a reinforcing member disposed within at least one of the sealed acoustic window or the outer sheath.

12. The intraluminal device according to claim 11, wherein, The reinforcing element includes a coil, braid, or hysteresis tube.

13. The intracavitary device according to claim 1 further includes multiple optical fibers.

14. The intraluminal device according to claim 1, further comprising: A telescopic internal component coupled to the optical fiber; as well as A telescopic external component coupled to the outer sheath. This allows the optical fiber to translate longitudinally within the outer sheath when the telescopic outer component is stationary and the telescopic inner component is longitudinally translated relative to the telescopic outer component.

15. The intra-cavity device according to claim 1, wherein, The chamber includes a volume within the outer sheath, in which the first light beam reacts with the photoreactive fluid to generate the first set of pressure waves.

16. An apparatus comprising: An intravascular lithotripsy catheter, configured for intravascular positioning and comprising: An outer sheath includes a sealed distal end, a reaction chamber, and a sealed acoustic window, the reaction chamber being configured to be filled with a photoreactive fluid; Optical fiber, which is configured to couple to a laser source; Telescopic internal components, which are coupled to the optical fiber; and A telescopic external component, which is coupled to the outer sheath. Specifically, when the telescopic outer component is stationary and the telescopic inner component is longitudinally translated relative to the telescopic outer component, the optical fiber is configured to longitudinally translate within the outer sheath from a first longitudinal position and a second longitudinal position. Specifically, when the optical fiber is in the first longitudinal position and when the optical fiber is in the second longitudinal position, the laser emitted by the optical fiber is configured to cause the photoreactive fluid to generate a pressure wave, which is transmitted to the blood vessel via the sealed acoustic window. The sealed acoustic window and the sealed distal end prevent the photoreactive fluid from entering the blood vessel.

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