Intravascular laser lithotripsy catheter

Abstract

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

Description

INTRAVASCULAR LASER LITHOTRIPSY CATHETERTECHNICAL FIELD

[0001] The subject matter described herein relates to systems, devices, and methods for generating shockwaves and directing ablative laser light within a body lumen of a patient. The intravascular laser lithotripsy catheter disclosed herein has particular but not exclusive utility for fracturing of calcified vascular stenoses inside of a blood vessel.BACKGROUND

[0002] Many individuals (especially elderly individuals) suffer from progressively enlarging vascular calcium mineral deposits. Such vascular calcification can cause symptoms such as compromised vascular integrity, vascular stenoses, hypertension, enlargement of the heart, ischemia, and congestive heart failure. The severity and extent of mineralization are strong predictors for morbidity and mortality. Vascular calcification may be recognized as a pathobiological process similar in some ways to bone formation. Vascular (e.g., arterial and venous) calcifications can be a persistent problem when treating coronary or peripheral vessels.

[0003] Vascular calcification may in many cases be co-morbid with other vascular diseases such as arterial plaques, which may be treated through combinations of laser atherectomy, balloon angioplasty, and / or stenting. However, vascular calcifications may be rigid enough to resist expansion by a stent or balloon, making such combined stenoses difficult to treat.

[0004] The information included in this Background section of the specification, including any references cited herein and any description or discussion thereof, is included for technical reference purposes only and is not to be regarded as subject matter by which the scope of the disclosure is to be bound.SUMMARY

[0005] Disclosed is an intravascular laser lithotripsy catheter which has particular, but not exclusive, utility for ablating vascular plaques and fracturing calcified vascular stenoses. The intravascular laser lithotripsy catheter has a shockwave functionality for cracking the calcium in the radial direction, without releasing a contrast agent or other photoreactive liquid into the patient’s body. The intravascular laser lithotripsy catheter includes both an optical fiber and a sealed reaction chamber, in acoustical communication with the blood volume inside the vessel, where the photoreaction can take place without release of the photoreactive fluid or its reaction products into the patient’s bloodstream. These structures reside within a telescoping catheter that includes a stationary sheath to be positioned within the patient 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 delivering pressure waves. The intraluminal device includes a flexible elongate member configured for positioning within a body lumen and may include: an outer sheath 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 translated longitudinally within the outer sheath. When the chamber is filled with a photoreactive fluid, a first beam of light emitted by the optical fiber is configured to cause the photoreactive fluid to generate a first set of pressure waves that is delivered to a first location of the body lumen via the sealed acoustic window. The sealed acoustic window and the sealed distal end prevent the photoreactive fluid from entering the body lumen.

[0007] Implementations may include one or more of the following features. In some aspects, the optical fiber is configured to be translated longitudinally within the outer sheath, and, after the optical fiber is moved to a second location of the body lumen, a second beam of light emitted by the optical fiber is configured to cause the photoreactive fluid to generate a second set of pressure waves that is delivered to the second location of the body lumen 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 of a distal end of the optical fiber and proximal of the sealed distal end of the outer sheath. In some aspects, the outer sheath may include a fluidbearing lumen in fluid communication with the chamber, where the chamber is configured to be filled with the photoreactive fluid via the fluid-bearing lumen. In some aspects, thephotoreactive fluid may include an X-ray contrast fluid. In some aspects, the first beam of light 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 intraluminal device may include rapid exchange guidewire lumen disposed distal of the sealed distal end of the outer sheath. In some aspects, the intraluminal 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, a braid, or a hypotube. In some aspects, the intraluminal device may include a plurality of optical fibers. In some aspects, the intraluminal device may include: a telescoping inner member coupled to the optical fiber; and a telescoping outer member coupled to the outer sheath, such that, when the telescoping outer member is stationary and the telescoping inner member is translated longitudinally with respect to the telescoping outer member, the optical fiber is translated longitudinally within the outer sheath. In some aspects, the chamber may be a volume inside the outer sheath where a reaction between the first beam of light and the photoreactive fluid occurs 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 comprising a sealed distal end, a reaction chamber configured to be filled with a photoreactive fluid, and a sealed acoustic window; an optical fiber configured to be coupled to a laser light source; a telescoping inner member coupled to the optical fiber; and a telescoping outer member coupled to the outer sheath, wherein, when the telescoping outer member is stationary and the telescoping inner member is translated longitudinally with respect to the telescoping outer member, the optical fiber is configured to be translated longitudinally within the outer sheath from a first longitudinal location and a second longitudinal location, wherein, when the optical fiber is at the first longitudinal location and when the optical fiber is at the second longitudinal location, laser light emitted by the optical fiber is configured to cause the photoreactive fluid to generate pressure waves that are delivered 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, wherein the sealed acoustic window and the sealed distal end prevent the photoreactive fluid from entering the blood vessel.

[0009] Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium.

[0010] A system of one or more computers can be configured to perform particular operations or actions by virtue of having software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions. One or more computer programs can be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus to perform the 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 methods.

[0011] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. A more extensive presentation of features, details, utilities, and advantages of the intravascular laser lithotripsy catheter, as defined in the claims, is provided in the following written description of various aspects of the disclosure and illustrated in the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Illustrative aspects of the present disclosure will be described with reference to the accompanying drawings, of which:

[0013] Figure 1 is a schematic, diagrammatic representation of an example intravascular treatment system with intravascular laser lithotripsy catheter, in accordance with at least one aspect of the present disclosure.

[0014] Figure l is a diagrammatic, schematic, lateral cross-sectional view of at least a portion of an example intravascular laser lithotripsy catheter, in accordance with at least one aspect of the present disclosure.

[0015] Figure 3A is a diagrammatic, schematic, lateral cross-sectional view of at least a portion of an example intravascular laser lithotripsy catheter, in accordance with at least one aspect of the present disclosure.

[0016] Figure 3B is a diagrammatic, schematic, lateral cross-sectional view of at least a portion of an example intravascular laser lithotripsy catheter, in accordance with at least one aspect of the present disclosure.

[0017] Figure 4 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of an example intravascular laser lithotripsy catheter, in accordance with at least one aspect of the present disclosure.

[0018] Figure 5 is a diagrammatic, schematic, lateral cross-sectional view of at least a portion of the flexible elongate member of an example intravascular laser lithotripsy catheter, in accordance with at least one aspect of the present disclosure.

[0019] Figure 6 is a diagrammatic, schematic, lateral cross-sectional view of at least a portion of the flexible elongate member of an example intravascular laser lithotripsy catheter, in accordance with at least one aspect of the present disclosure.

[0020] Figure 7 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of an example intravascular laser lithotripsy catheter, in accordance with at least one aspect of the present disclosure.

[0021] Figure 8 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of an example intravascular laser lithotripsy catheter, in accordance with at least one aspect of the present disclosure.

[0022] Figure 9 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of an example intravascular laser lithotripsy catheter, in accordance with at least one aspect of the present disclosure.

[0023] Figure 10 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of an example intravascular laser lithotripsy catheter, in accordance with at least one aspect of the present disclosure.

[0024] Figure 11 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of an example intravascular laser lithotripsy catheter, in accordance with at least one aspect of the present disclosure.

[0025] Figure 12 shows a flow diagram of an example calcified stenosis fracturing method 1100, in accordance with at least one aspect of the present disclosure.

[0026] Figure 13 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of blood vessel undergoing treatment by an example intravascular laser lithotripsy catheter, in accordance with at least one aspect of the present disclosure.

[0027] Figure 14 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of blood vessel undergoing treatment by an example intravascular laser lithotripsy catheter, in accordance with at least one aspect of the present disclosure.

[0028] Figure 15 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of blood vessel after treatment by an intravascular laser lithotripsy catheter, in accordance with at least one aspect of the present disclosure.

[0029] Figure 16 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of blood vessel after treatment by an intravascular laser lithotripsy catheter, in accordance with at least one aspect of the present disclosure.

[0030] Figure 17 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of blood vessel after treatment by an intravascular laser lithotripsy catheter and a balloon catheter, in accordance with at least one aspect of the present disclosure.

[0031] Figure 18 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of blood vessel undergoing treatment by an example intravascular laser lithotripsy catheter, in accordance with at least one aspect of the present disclosure.

[0032] Figure 19 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of blood vessel undergoing treatment by an example intravascular laser lithotripsy catheter, in accordance with at least one aspect of the present disclosure.

[0033] Figure 20 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of blood vessel undergoing treatment by an example intravascular laser lithotripsy catheter, in accordance with at least one aspect of the present disclosure.

[0034] Figure 21 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of blood vessel undergoing treatment by an example intravascular laser lithotripsy catheter, in accordance with at least one aspect of the present disclosure.

[0035] Figure 22 is a schematic diagram of a processor circuit, in accordance with at least one aspect of the present disclosure.DETAILED DESCRIPTION

[0036] Intravascular lithotripsy (IVL) is already used in coronary and vascular disease to disrupt calcium within diseased vessels, allowing administration of therapies such as balloon angioplasty and stenting. IVL involves creating ultrasonic waves that, when propagated into hard materials such as large calcium deposits in a vessel wall, create fractures and fissures in the deposit. Fracturing these calcium deposits allows the ability to apply percutaneous coronary intervention (PCI) therapies such as balloon angioplasty and the implantation of stents.

[0037] There are various ways to create the ultrasonic waves for lithotripsy. One current device on the market is in the form of an angioplasty balloon incorporating electrodes within the inner shaft at the location of the balloon. Energy is delivered across the electrodes which, when interacting with the medium inside the balloon, generates ultrasonic waves providing the lithotripsy effect (shockwaves). Other devices release X-ray contrast fluids into the patient’s bloodstream, with potentially deleterious effects.

[0038] The present disclosure describes a laser-based lithotripsy device that addresses concerns with exposure to contrast agents and improves deliverability of the lithotripsy function to desired locations in the vasculature. This technology leverages the configuration of a sealed intravascular catheter containing optical fiber(s). This configuration of a laserbased lithotripsy device addresses concerns with deliverability, lasing-medium containment and limited-length therapy application.

[0039] The leading IVL device on the market (manufactured by Shockwave Medical) has several limitations. The distance over which the shockwaves are applied are limited to the length of the balloon on the device. For vessels with long stretches of calcium, the balloon would need to be repositioned and re-deployed a multitude of times to cover the desired therapy area. Repositioning of devices within the vasculature increases procedure time, as well as increased risk of damage to vasculature. Also, due to the balloon catheter configuration of the device, bulk / rigidity / profile of certain areas of the catheter, and other design elements (potentially also being an over-the-wire design), the device deliverability (i.e. the ability to navigate the balloon through the vasculature and position it where needed) is limited.

[0040] Other design concepts (some, laser-based) address deliverability (via smaller profile or no balloon) or application area of therapy (via variable positioning of the laser tip), but none adequately address all constraints simultaneously. Concepts which contain thelasing medium usually incorporate a balloon, limiting deliverability and therapy location. Concepts improving deliverability and flexibility in therapy application distance usually involve microcatheter configurations in conjunction with an open-ended sheath, allowing flow of lasing medium / contrast into the vasculature. As stated above, the present disclosure provides a laser-based lithotripsy device that addresses concerns with exposure to contrast agents, deliverability, and delivery of the therapy to (perhaps multiple) desired locations in the vasculature.

[0041] More particularly, the present disclosure provides a intravascular laser lithotripsy catheter for a intravascular treatment system. The intravascular laser lithotripsy catheter is configured to subject vascular calcifications to fatigue fracture, and thus help to enable dilation of the stenosis. Calcifications tend to be well rooted into soft tissue, or even completely encapsulated by soft tissue, such that fracturing the calcification does not generally release the calcified material into the bloodstream. The fracturing process may for example be analogous to breaking up a bag of frozen-together ice cubes, without opening the bag.

[0042] The present disclosure may for example be applicable to treating calcified chronic total occlusions (CTOs) with a catheter device capable of producing shockwaves to modify the calcium in or surround the CTO. The presence of calcium lesions in and surrounding the total occlusion may preclude typical catheter-based treatments (e.g., inflating a balloon or placing a stent). Devices such as electrically induced shockwave balloon catheters (e.g., to modify the calcium through fracturing) can be used, such that ballooning or stenting becomes possible. However, such an electrically actuated shockwave balloon catheter may only be effective when it can enter the stenosis. In the case of a calcified CTOs, this may be difficult or impossible.

[0043] As described for example in US Patent No. 11,058,492, incorporated by reference as though fully set forth herein, such calcified CTOs may be treatable with a device that is capable of penetrating a calcified and / or fibrous vascular occlusion, particularly a calcified cap(s), and disrupting at least a portion of the vascular occlusion as the device penetrates and traverses the total occlusion. The device may be able to produce laser induced pressure waves to the vascular occlusion to disrupt the calcified and / or fibrous portions.

[0044] the laser can be used to initiate an exothermic reaction in the photoreactive fluid that generates shockwaves (also known as pressure waves, acoustic waves, acoustic shock, or hydraulic shock). These shockwaves can fracture the calcified tissue embedded in the vesselwall, without damaging the soft tissue of the vessel wall itself. However, existing systems allow photoreactive fluid (e.g., X-ray contrast fluid) to flow into the patient’s vasculature.

[0045] In some aspects, US Patent No. 11,058,492 (see FIG. 33 therein), describes the combination of first performing an atherectomy procedure on the vascular obstruction with the laser catheter beyond the distal end of the surrounding sheath, then followed by a pressure wave procedure. In this second procedure, the laser catheter and the sheath are positioned such that a pressure wave reflective element within the sheath is adjacent an occlusion with the vessel and the distal end of the laser catheter is disposed within the pressure wave reflective element and the sheath. Photoreactive liquid is introduced and the laser is activated to disrupt the obstruction. Hence, this reference discloses a laser catheter and a sheath where during the atherectomy the laser is beyond the end of the sheath and during the pressure wave procedure the laser catheter is completely inside the sheath.

[0046] However, some patients may be allergic to the photoreactive liquid or the photoreaction products. Even in cases where an allergy is not present, the photoreactive liquid or its reaction products may cause unwanted side effects (e.g., in patients with kidney failure or other vulnerabilities). Such side effect may include, but are not limited to, acute kidney injury, exacerbation of chronic kidney disease, or an anaphylactic response to the materials.

[0047] Thus, the present disclosure provides a device that has a highly localized shockwave functionality for cracking the calcium in the radial direction without releasing a contrast agent or other photoreactive liquid into the patient’s body.

[0048] In some aspects, the intravascular laser lithotripsy catheter includes a reaction chamber, in acoustical communication with the blood volume inside the vessel, where the photoreaction can take place without release of the photoreactive fluid or its reaction products into the environment surrounding the device. Depending on the implementation, the intravascular laser lithotripsy catheter may produce a sudden pressure wave (e.g., a shockwave) in the blood vessel, or may produce repeated shocks, or may produce a timevarying (e.g., sinusoidal) pressure. A shockwave may for example occur when the expansion of a fluid, or motion of an object through the fluid, exceeds the fluid’s local speed of sound, resulting in a sudden pressure change or series of sudden pressure changes.

[0049] The present disclosure provides a system including an optical fiber (whether single-stranded or multi-stranded), a sheath around the optical fiber and sealed at its distal end, a reaction chamber occupying the space between the laser catheter and the sealed distal end, and a fluid-bearing lumen surrounding the optical fiber and in fluid communication withthe reaction chamber. The liquid in the reaction chamber can be an opaque, photoreactive liquid (e.g., X-ray contrast liquid) that is able to generate shockwaves as part of the reaction with laser light. Furthermore, the sheath includes acoustic windows (e.g., one or more portions made from an acoustically transparent polymer or hydrogel that has a similar speed of sound to the surrounding medium to allow shockwaves to pass from the interior to the exterior of the device, while the liquid remains confined inside the reaction chamber. The system can produce shockwaves that can pass radially outward through the acoustic windows of the sheath.

[0050] In some aspects, a guidewire lumen or rapid exchange port is present, and is in fluid communication with the patient’s bloodstream but not with the fluid-bearing lumen or the reaction chamber.

[0051] Once the intravascular laser lithotripsy catheter has been positioned within a vessel of interest (e.g., a vessel containing one or more calcified stenoses), the optical fiber can be advanced or pulled back within the sheath, thus moving the distal end of the optical fiber and this the location of the photoreaction, without the need to move the sheath itself. The intravascular laser lithotripsy catheter is thus capable of treating multiple calcified stenoses along a working length of a blood vessel of potentially up to 15 centimeters (although other working lengths both larger and smaller may be used instead or in addition), without the need to repeatedly reposition the sheath. Thus, lithotripsy procedures can be performed more rapidly and with less risk of injury to the blood vessel than would be possible with present systems, and also without the risk of photoreactive fluid entering the patient’s bloodstream. The telescoping function of the intravascular laser lithotripsy catheter may be related in some respects to telescoping catheter mechanisms described for example in U.S. Patent No 10,993,694 and U.S. Patent No. 10,448,922, each of which is incorporated by reference as though fully set forth herein.

[0052] The intravascular laser lithotripsy catheter contains a laser-based IVL incorporating laser fiber (or fiber bundle) and lasing material (e.g., X-ray contrast material) housed within a closed outer tube (e.g., a sealed distal section of the catheter). The laser fiber / bundle is able to translate axially within the enclosed outer tube such that the tip can traverse at least but not limited to 15cm within the closed outer tube (“telescoping feature”). This feature thus provides flexibility to place the laser fiber bundle at any or multiple sections within the length of the enclosed outer tube to apply the therapy. The annular space between the laser fiber / bundle can be filled with contrast fluid or other photoreactive medium through a fill port at the proximal end of the catheter. The photoreactive fluid is contained within anannular space between the fiber optic bundle and the outer sheath. The sealed outer sheath acts as a fluid barrier and acoustic window, or else includes multiple acoustic windows along its length. The catheter can also have a “rapid exchange” guidewire port within the tip of the catheter distal end to the distal end of the enclosed outer tube section. This allows for a low profile of the distal section of the catheter enclosing the fiber / bundle and lasing medium. In an example, the outer profile of the distal portions of the intravascular laser lithotripsy catheter is approximately 3 French (3Fr, or 1 mm), although other diameters both larger and smaller may be used instead or in addition. This configuration allows for improved deliverability, similar to that of rotational IVUS catheters.

[0053] The present disclosure aids substantially in the treatment of calcified stenoses, by improving a clinician’s ability to deliver high pressures to the calcification without introducing chemicals into the patient’s bloodstream. In acoustic communication with blood in the vessel, the intravascular laser lithotripsy catheter disclosed herein provides a practical ability to deliver pressure waves, shockwaves, or vibrations to a calcified stenosis, without introducing contrast fluid or other reactive materials into the patient’s bloodstream. Indeed, the distal, portion of the device may be completely sealed, and may not need to be relocated in order to treat multiple calcified locations within a vessel. This improved intravascular therapy technique transforms a solid calcification into a number of tissue-bound fragments, without the normally routine need to ablate or cut the calcified tissue or disturb the soft tissue around it. This unconventional approach improves the functioning of the intravascular treatment system, by permitting pressure waves or shockwaves to be delivered to multiple locations by a single, sealed device.

[0054] The intravascular laser lithotripsy catheter may be controlled manually, or through an automated process at least partially viewable on a display and executing on a processor that accepts user inputs from a keyboard, mouse, touchscreen interface, or other user interface. In that regard, 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 systems are known in the art, while others are recited herein to enable novel features or aspects of the present disclosure with particularity.

[0055] These descriptions are provided for exemplary purposes only and should not be considered to limit the scope of the intravascular laser lithotripsy catheter. Certain features may be added, removed, or modified without departing from the spirit of the claimed subject matter.

[0056] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the aspects illustrated in the drawings, and specific language will be used to describe the same. It is nevertheless understood that no limitation to the scope of the disclosure is intended. Any alterations and further modifications to the described devices, systems, and methods, and any further application of the principles of the present disclosure are fully contemplated and included within the present disclosure as would normally occur to one skilled in the art to which the disclosure relates. In particular, it is fully contemplated that the features, components, and / or steps described with respect to one aspect may be combined with the features, components, and / or steps described with respect to other aspects of the present disclosure. For the sake of brevity, however, the numerous iterations of these combinations will not be described separately.

[0057] Figure l is a schematic, diagrammatic representation, in block diagram form, of an example intravascular treatment system 100 with intravascular laser lithotripsy catheter 102, in accordance with at least one aspect of the present disclosure. The intravascular treatment system 100 includes a console or workstation 130 and an intravascular laser lithotripsy catheter 102.

[0058] The console 130 of an unsealed laser-induced pressure wave emitting catheter and sheath is described for example in US Patent No. 11,058,492 and US Patent No. 11,246,659, each of which is incorporated by reference as though fully set forth herein, along with background information relating to the problems addressed by the present disclosure. In the example shown in Figure 1, the console 130 includes a housing 135, a display 108 (e.g., a touchscreen display), a user interface 137 (which may for example include virtual controls on the touchscreen display and / or physical knobs, buttons, etc.), a processor circuit 106, and a light source 140, such as a UV laser light source emitting within the range of 100-400 nm.

[0059] Components shown as being inside the console 130 may be in separate housings (e.g., different consoles). For example, there could be a separate light source console. The light source console can be a housing with the light source, a processor circuit, display, user interface for control of the light source. The console 130 interfaces with an intravascular laser lithotripsy catheter 102 (also known as an intravascular telescoping pressure wave device). In the example shown in Figure 1, the intravascular laser lithotripsy catheter 102 includes a flexible elongate member 115 comprising a guidewire lumen or rapid exchange port 236, optical fiber 105, and an outer sheath 103. In some aspects, the flexible elongate member is guided through the vasculature of the patient by a guidewire 118. In an example, the guidewire 118 is stationary within the patient’s vasculature, and the flexible elongatemember 115 is slid over the guidewire via the guidewire lumen or rapid exchange port 236 until the distal end of the flexible elongate member has reached the stenosis within the vessel of interest.

[0060] The intravascular laser lithotripsy catheter includes an intravascular pressure wave generating device, but with a sealed distal end such that no photoreactive liquid is introduced into the bloodstream of the patient. The composition and structure of the optical fiber 105 and sheath 103 may for example be similar to those described in US Patent No. 11,058,492 and US Patent No. 11,246,659.

[0061] In the example shown in Figure 1, the light source 140 is in optical communication with the optical fiber 105 by an optical communication line 145, such as an optical fiber or bundle of optical fibers. Similarly, a pressure wave fluid source 170 (e.g., a syringe) is in fluid communication with the sheath via a fluid channels 180. Depending on the implementation, the photoreactive pressure wave fluid may be a liquid, a gas, or combinations thereof.

[0062] In order to provide the benefits pressure wave generation, without the need for precise repositioning of the sheath and without introducing the pressure wave fluid or photoreactive fluid into the bloodstream of the patient, the intravascular laser lithotripsy catheter 102 provides a optical fiber 105 and sheath 103 that are movable relative to one another. Furthermore, the distal end of the intravascular laser lithotripsy catheter 102 is sealed, such that the fluids used by the device (e.g., the pressure wave fluid) remain inside the distal end of the device (although, depending on the implementation, they may exit at or near the proximal end of the sheath).

[0063] In other cases, the optical fiber 105 of the intravascular laser lithotripsy catheter 102 may be pulled back or advanced manually by a clinician. In some implementations, the optical fiber 105 may be pulled back within the stationary sheath by a pullback device 199, which may or may not be under the control of the console 130. A pullback device 199 is not required. The pullback device 199 can be a separate accessory that attaches to a feature on the proximal end of the catheter.

[0064] It is understood that block diagrams are provided herein for exemplary purposes; a person of ordinary skill in the art will recognize myriad variations that nonetheless fall within the scope of the present disclosure. For example, block diagrams may show a particular arrangement of components, modules, services, steps, processes, or layers, resulting in a particular flow of data, light, fluids, etc. It is understood that some embodiments of the systems disclosed herein may include additional components, that some components shownmay be absent from some aspects, and that the arrangement of components may be different than shown, resulting in different data flows while still performing the methods described herein.

[0065] Before continuing, it should be noted that the examples described above are provided for purposes of illustration and are not intended to be limiting. Other devices and / or device configurations may be utilized to carry out the operations described herein.

[0066] Figure l is a diagrammatic, schematic, lateral cross-sectional view of at least a portion of an example intravascular laser lithotripsy catheter 102, in accordance with at least one aspect of the present disclosure. The intravascular laser lithotripsy catheter 102 includes a proximal connector 210 that serves as a connector for both the optical fiber 105 and the optional pullback device 199 (see Figure 1). The intravascular laser lithotripsy catheter 102 also includes a photoreactive fluid fill port or pressure wave fluid fill port 230, to which a pressure wave fluid source 170 (e.g., a syringe - see Figure 1) can be attached, to inject the photoreactive fluid into the sheath. The intravascular laser lithotripsy catheter 102 also includes an optical fiber 220, which may comprise a single optical fiber or multiple optical fibers, and which carries the laser energy from the light source 140 (see Figure 1). The intravascular laser lithotripsy catheter 102 also includes a telescoping inner member 240, which is a flexible elongate member such as a catheter which encloses the optical fiber 105. The telescoping inner member 240 fits slidably within a lumen of a telescoping outer member 250, such that when the telescoping inner member 240 is pulled back, the length L of the intravascular laser lithotripsy catheter 102 increases by an amount AL. In an example, AL can be up to a working length of 150 mm, although other working distances both larger and smaller may be used instead or in addition. The sheath 260, telescoping inner member 240, telescoping outer member 250, and optical fiber 105 collectively form a flexible elongate member 115.

[0067] Distal of the telescoping outer member 250 is the sheath 260, through which the optical fiber 105 can translate as the telescoping inner member 240 is pulled back or advanced. A 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 sealed end 280, which also forms the sealed end of a reaction chamber 290. Distal of the sealed end 290 is a monorail or rapid exchange track 295, which includes the guidewire lumen or rapid exchange port 236 (see Figure 1).

[0068] Two longitudinal directions, proximal and distal, are marked in Figure 2. It is understood that radial directions relative to the intravascular laser lithotripsy catheter 102 are orthogonal to these longitudinal directions.

[0069] Figure 3A is a diagrammatic, schematic, lateral cross-sectional view of at least a portion of an example intravascular laser lithotripsy catheter 102, in accordance with at least one aspect of the present disclosure. Visible are the telescoping outer member 250, telescoping inner member 240, fill port 230, and optical fiber 105. In the example shown in Figure 3A, the proximal connector 210 has been replaced with a proximal connector 302, that serves as a connector for only the optical fiber 105. The connector 302 is also spaced from the fill port 230 by an extra length 308 of catheter, which may be useful for example in positioning equipment around the workstation and / or the patient.

[0070] Figure 3B is a diagrammatic, schematic, lateral cross-sectional view of at least a portion of an example intravascular laser lithotripsy catheter 102, in accordance with at least one aspect of the present disclosure. Visible are the telescoping outer member 250, telescoping inner member 240, fill port 230, and optical fiber 105. In the example shown in Figure 3A, the proximal connector 210 has been replaced with a proximal connector 304, for the optical fiber 105 and a proximal connector 306 for the pullback device 199 (see Figure 1). The connectors 304, 306 are also spaced from the fill port 230 by an extra length 308 of catheter, which may be useful for example in positioning equipment around the workstation and / or the patient.

[0071] Figure 4 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of an example intravascular laser lithotripsy catheter 102, in accordance with at least one aspect of the present disclosure. Visible is the flexible elongate member 115, including the sheath 103, optical fiber 105, guidewire lumen or rapid exchange port 236, and fluid-bearing lumen 215. The fluid-bearing lumen 215 is an annular space within the sheath and surrounding the optical fiber 105 that is filled with a photoreactive fluid such as X-ray contrast material.

[0072] The distal portion 310 of the sheath 103 is delivered to the desired location within the vasculature over the guidewire 118 (in an example, a .014” guidewire). The optical fiber 105 is placed in the desired therapy location within the length of the sheath, and the laser is activated to lase the contrast media and apply the therapy at that location. Alternatively, the tip of the laser can be positioned in one location of the desired therapy and translated while the laser is activated to apply the therapy over a desired distance within the enclosed tube

[0073] The distal portion 310 of the sheath 103 includes a sealed end 340. The sheath 103 surrounding the optical fiber 105 includes a fluid-bearing lumen 315 that allows fluid to enter a cavity or reaction chamber 320 between the exit or distal end 350 of the optical fiber 105 and the sealed end 340. When this reaction chamber 320 is filled with a photoreactive fluid (e.g., X-ray contrast liquid), activation of the optical fiber 105 can generate shockwaves (e.g., pressure waves of 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 for example be made of an acoustically transparent material such as Pebax, polyethylene, etc., to allow shockwaves to pass through, while preventing vapor bubbles, photoreactive liquid, or reaction products from exiting the flexible elongate member 115. The acoustic windows 330 extend for a distance Dw along the sheath 103, which may in some cases be the entire length of the sheath 130 or the entire working distance AL of the intravascular laser lithotripsy catheter 102, but may also be a shorter distance, depending on the implementation.

[0074] As a result, the system functions as a shockwave generation device when the photoreactive liquid is in the cavity. No mechanical movements of the laser optical fiber 105 with respect to the sheath 103 is required for this. However, translation (e.g., pullback) of the laser optical fiber 105 within the sheath 103 can allow treatment over a larger area, or multiple areas, without requiring any movement of the sheath itself. To avoid blood entering the sheath 103, the distal portion 310 of the sheath 103 is sealed by the acoustic windows 330 and the sealed end 340. Thus, the fluid is completely sealed within volume inside sheath 103 (e.g., within the fluid-bearing lumen 315 and reaction chamber 320). No fluid enters the ambient environment (e.g., the blood vessel, the blood inside the blood vessel). This is advantageous because some patients can have adverse reactions to fluids like radiopaque contrast.

[0075] In some aspects, radiopaque markers 370 may be used to mark the location of the monorail or rapid exchange track 295, such that its location can be seen on X-ray fluoroscopy. In an example, the radiopaque markers 370 are separated from a distal end of the acoustic windows by a known distance DRW, which can help the user (e.g., a vascular surgeon) to align the acoustic windows with a calcified stenosis, as described below.

[0076] For maneuverability within the tortuous vasculature of the patient, and for navigation through the narrowing of a stenosis (particularly a calcified stenosis), it is desirable for the outer diameter OD of the sheath 103 to be as small as possible. In anexample, OD is between 0.66 mm and 1.33 mm, although other values both larger and smaller may be used instead or in addition. The diameter DL of the laser optical fiber 105 should be large enough to carry sufficient laser energy to carry out the lithotripsy portion of the procedure, while still leaving adequate room in the fluid-bearing lumen 215 to transport photoreactive fluid to the reaction chamber 320. In an example, the diameter of the laser optical fiber is between 50 microns and 1000 microns.

[0077] Figure 5 is a diagrammatic, schematic, lateral cross-sectional view of at least a portion of the flexible elongate member 115 of an example intravascular laser lithotripsy catheter 102, in accordance with at least one aspect of the present disclosure. Visible are the sheath 103, optical fiber 105, and fluid-bearing lumen 215. In the example shown in Figure 5, the optical fiber 105 includes a single optical fiber core 205 (e.g., made of silica) surrounded by a layer of cladding 510 (e.g., also silica), and an outer layer of polymer 520. In some instances, the core 205, the cladding 510, and the polymer 520 (or the optical fiber 105) can be referred to as a fiber optic cable. The optical fiber 105 is surrounded by the fluid-bearing lumen 215 of the sheath 103. During the pressure wave generation portion of the procedure, the fluid-bearing lumen is filled with a photoreactive pressure wave fluid (e.g., X-ray contrast fluid or other photoreactive fluid) from the pressure wave fluid source 170, which can be used to generate shockwaves as described below.

[0078] Figure 6 is a diagrammatic, schematic, lateral cross-sectional view of at least a portion of the flexible elongate member 115 of an example intravascular laser lithotripsy catheter 102, in accordance with at least one aspect of the present disclosure. Visible are the sheath 103, optical fiber 105, and fluid-bearing lumen 215. In the example shown in Figure 5, the optical fiber 105 includes multiple optical fiber cores 205 (e.g., made of silica, surrounded by a layer of silica cladding and an outer layer of polymer). The optical fiber 105 is surrounded by the fluid-bearing lumen 215 of the sheath 103. During the pressure wave generation portion of the procedure, the fluid-bearing lumen is filled with a photoreactive pressure wave fluid (e.g., X-ray contrast fluid or other photoreactive fluid) from the pressure wave fluid source 170, which can be used to generate shockwaves as described below.

[0079] Figure 7 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of an example intravascular laser lithotripsy catheter 102, in accordance with at least one aspect of the present disclosure. Visible are the sheath 103, optical fiber 105, sealed end 340, fluid-bearing lumen 215, reaction chamber 320, and acoustic windows 330. The chamber or reaction chamber 320 can be the volume inside the outer sheath 103 wherethe reaction between the light emitted by the optical fiber 105 and the photoreactive fluid 410 occurs to generate pressure waves 440.

[0080] In the example shown in Figure 7, the fluid-bearing lumen 215 and reaction chamber 320 are filled with a photoreactive liquid or pressure wave fluid 410. In a nonlimiting example, some X-ray contrast fluids such as loversol, loxilan, or other commercially available iodine-containing injectable X-ray contrasts produce an exothermic reaction when struck by ultraviolet light, and can thus serve as a photoreactive liquid 410. Thus, when the optical fiber 105 emits laser light 420 into the photoreactive liquid 410, the laser light produces chemical or physical reactions 430 that can generate shockwaves or pressure waves 440 by, for example, producing rapidly expanding gas bubbles. The shockwaves or pressure waves 440 can then pass from the reaction chamber 320 into the exterior environment (e.g., the blood moving within a blood vessel) via the acoustically transparent windows 330. It is noted that in the example shown in Figure 7, shockwaves or pressure waves 440 are being emitted laterally, in a radial direction relative to the sheath 103. Depending on the configuration of the acoustic windows 330, the shockwaves or pressure waves may be emitted on one side only, on one side and another side (whether opposite or otherwise), through an annular ring fully encircling the sheath 103, or combinations thereof. The laser light 420 can be one pulse or beam (e.g., a continuous pulse / beam) or a series of pulses or beams (e.g., multiple separate pulses / beams). In some instances the pressure waves 440 are generated by a portion of the light emitted by the optical fiber 105.

[0081] Examples of contrast fluids can be found in US Patent No. 11,058,492 and US Patent No. 11,246,659.

[0082] Figure 8 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of an example intravascular laser lithotripsy catheter 102, in accordance with at least one aspect of the present disclosure. Visible are the sheath 103, optical fiber 105, sealed end 340, fluid-bearing lumen 215, reaction chamber 320, and acoustic windows 330. In the example shown in Figure 8, the acoustic windows 330 include reinforcements 810. The reinforcements 810 may for example include a coil, a braid, a laser-cut hypotube, or other structure embedded in the polymer of the acoustic windows in order to add mechanical strength. This may for example be necessary where the acoustically transparent polymer of the acoustic windows 330 is less mechanically strong than the polymer(s) from which other portions of the sheath 103 are made, and / or because the shockwaves generated by the laser put high mechanical stress on the acoustic windows 330.

[0083] Figure 9 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of an example intravascular laser lithotripsy catheter 102, in accordance with at least one aspect of the present disclosure. Visible are the sheath 103, optical fiber 105, sealed end 340, fluid-bearing lumen 215, reaction chamber 320, and acoustic windows 330. Figure 9 is similar to Figure 8. However, in the example shown in Figure 9, the acoustic reinforcements 810 extend through not only the polymer of the acoustic windows 330 but also that of the sheath 103. This may for example be necessary where enhanced mechanical strength is desired for the sheath 103, including the acoustic windows 330.

[0084] Figure 10 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of an example intravascular laser lithotripsy catheter 102, in accordance with at least one aspect of the present disclosure. Visible are the telescoping inner member 240, telescoping outer member 250, sheath 103, and optical fiber 105, including its laser-emitting distal end 350.

[0085] The intravascular laser lithotripsy catheter 102 is formed from a first portion or telescoping portion 4 and a second portion 5. The telescoping portion 4 is operably associated with a proximal housing 1009 that may for example include the fill port 230 and connector 210 of Figure 2. The proximal housing 1009 can be translated manually or be coupled to a system (such a pullback device) that facilitates the movement of the proximal housing 1009. The optical fiber 105 terminates at an emissive distal end 350. As may be appreciated, the emissive distal end 350 could include an optical lens or mirror, depending on the intended use of the catheter. When the optical fiber 105 is translated within the sheath or catheter body 103, the emissive distal end 350 is able to generate calcium-cracking shockwaves along a length of a body lumen (such as a blood vessel).

[0086] The sheath or catheter body 103 includes a distal portion 5 and a proximal portion 3. The distal portion 5 is a portion of the sheath or catheter body 103 that is not disposed within the telescoping section 4. The distal portion 5 is the portion 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 telescoping portion 4 of the intravascular laser lithotripsy catheter 102. Thus, the sheath or catheter body 103 extends over the optical fiber 105 within the telescoping portion 4 such that the sheath or catheter body 103 provides additional support to the optical fiber 105. The sheath or catheter body 103 can be formed from a single material or multiple materials. In addition, the sheath or catheter body 103 may be segmented (e.g. of variable flexibility along its length). For example, the proximal portion 3 of the sheath or catheter body 103 within the telescopingportion 4 may be stiffer than the distal portion 5 of the sheath or catheter body 103, which may itself have a stiff proximal section and a more flexible distal section 310, depending on the implementation. Catheter bodies with variable thickness are described in more detail in U.S. Publication No. 2009 / 0018393, incorporated by reference as though fully set forth herein.

[0087] The telescoping section 4 includes an outer telescoping member 250, an inner telescoping member 240 that slides into the outer telescoping member 250, and an anchor housing unit 1010 with an optional fluid seal 1020. Although telescoping members 240 and 250 are described as tubular, it is understood that these members can have other shapes. The outer telescoping member 250 may be coupled to the sheath or catheter body 103 via catheter coupling 1030. The anchor housing unit 1010 is coupled to the outer telescoping member 250 and the sheath or catheter body 103. The anchor housing unit 1010 can be held, either manually or by a system (such as pullback device), in a fixed position, thereby also maintaining the positioning of the outer telescoping member 250 and the sheath or catheter body 103. The inner telescoping member 240 and the optical fiber 105 is operably associated with the proximal housing such that translation of the proximal housing 1009 causes the inner telescoping member 240 and the optical fiber 105 to likewise translate.

[0088] The proximal housing 1009 can likewise be associated with the system (such as a pullback device) that causes the proximal housing, the inner telescoping member 240, and optical fiber 105 to translate. It is important to note that optical fiber 105 is of a fixed length, so that when the inner telescoping member 240 of the telescoping section 4 is translated relative to the outer telescoping member 250 and sheath or catheter body 103, the laseremitting distal end 350 of the optical fiber 105 is likewise translated.

[0089] In addition to optical fiber 105, the outer telescoping member 250 is configured to receive the inner telescoping member 240 and the sheath or catheter body 103. The inner telescoping member 240 is configured to receive the sheath or catheter body 103 and the optical fiber 105. That is, the inner telescoping member 240 is sized to fit the outer diameter of the proximal section 3 of the sheath or catheter body 103. These configurations allow the inner telescoping member 240 and the optical fiber 105 to slideably translate relative to the outer telescoping member 250 and sheath or catheter body 103.

[0090] Figures 10 and 11 illustrate translation of the telescoping portion 104 during a treatment pullback. A treatment pullback is the translation of the laser-emitting distal end 350 of the giber optic cable 105 within a length of the sheath catheter body 103. During thepullback, the laser-emitting distal end 350 is able to generate shockwaves along a length of the vessel in which the catheter is disposed.

[0091] Figure 10 illustrates the intravascular laser lithotripsy catheter 102 in a fully nonextended position. In a fully non-extended position, the outer telescoping member 250, the inner telescoping member 240, and the proximal section 3 of the sheath or catheter body 103 are substantially concentrically aligned. When in the fully nonextended position, the emissive distal end 350 of the optical fiber 105 is at the distal end of the sheath or catheter body 103. Typically, shockwave-generating lithotripsy treatment is initiated when the emissive distal end 350 is at or the distal portion 310 of the sheath or catheter body 103, and then imaging transducer is pulled back (proximally) within the catheter body to generate shockwaves along a length of the sheath 103, such that telescoping section 4 transitions from a non-extended position to an extended position. In order to transition into an extended position, the inner telescoping member 240 and optical fiber 105 are moved in the proximal direction relative to the sheath or catheter body 103 and outer telescoping member 250.

[0092] Figure 11 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of an example intravascular laser lithotripsy catheter 102, in accordance with at least one aspect of the present disclosure. Visible are the telescoping inner member 240, telescoping outer member 250, sheath 103, optical fiber 105, including its laser-emitting distal end 350. Also visible are the anchor housing unit 1010, fluid seal 1020, proximal housing 1009, and catheter coupling 1030.

[0093] Figure 11 illustrates intravascular laser lithotripsy catheter 102 in a fully extended position. As shown in Figure 11, the inner telescoping member 240, optical fiber 105, and proximal housing 1009 have moved a length L in the distal direction. In an example, L can be up to 15 cm, although other working lengths both larger and smaller may be used instead or in addition. At the same time, the outer telescoping member 250, the anchor housing 1010 and the sheath or catheter body 103 maintain their positions within the body of the patient. This causes the emissive distal end 350 of the optical fiber 105 to likewise translate a distance L within the sheath or catheter body 103.

[0094] In an example, the distal portion 5 of the intravascular laser lithotripsy catheter 102 may range from 125 cm to 200 cm in length, although other lengths both larger and smaller may be used instead or in addition. As an alternative to pullback treatment, the intravascular laser lithotripsy catheter 102 is also configured to treat using a push-forward. For this imaging, the telescoping portion 4 of the catheter 100 transitions from an extended position to a non-extended position. In certain embodiments and as shown in FIG. 4, theinner telescoping member 240 may include stoppers 1033 that act to stop the proximal translation of the inner telescoping member 240 at a certain point. For example, the stoppers 1033 can be configured to prevent the inner telescoping member 240 from exiting a proximal end of the telescoping outer member 250.

[0095] In other cases, the telescoping inner member 240 may be pulled back or advanced manually by a clinician. In some implementations, the telescoping inner member 240 may be pulled back within the stationary sheath by the pullback device 199, which may or may not be under the control of the console 130.

[0096] Figure 12 shows a flow diagram of an example calcified stenosis fracturing method 1100, in accordance with at least one aspect of the present disclosure. It is understood that the steps of method 1100 may be performed in a different order than shown in Figure 12, additional steps can be provided before, during, and after the steps, and / or some of the steps described can be replaced or eliminated in other aspects. One or more of steps of the method 1100 can be carried out at least in part by one or more devices and / or systems described herein, such as components of the intravascular treatment system 100, processor circuit 106, and / or processor circuit 2250.

[0097] In step 1110, the method 1100 includes inserting the guidewire into the target blood vessel and advancing it to, or through, the target stenosis.

[0098] In step 1115, the method 1100 includes inserting the intravascular intravascular laser lithotripsy catheter into the target blood vessel over the guidewire, and advancing it until it is in proximity to the calcified stenosis at a first location.

[0099] In step 1120, the method 1100 includes using the pressure wave fluid source to provide pressure wave fluid (e.g., photoreactive liquid or X-ray contrast fluid) to the distal portion of the sheath via the fluid-bearing lumen.

[0100] In step 1125, the method 1100 includes controlling the light source to provide light (e.g., ultraviolet laser light) to the optical fiber.

[0101] In step 1130, the method 1100 includes emitting shockwaves or pressure waves into the walls of the blood vessel. These shockwaves are a consequence of the laser light interacting with the pressure wave fluid or photoreactive fluid, and are transmitted laterally / radially from the sheath via the acoustically transparent windows. The shockwaves or pressure waves can be used to fracture calcifications embedded in the vessel wall.

[0102] In step 1135, the method 1100 includes moving the optical fiber within the fluidbearing lumen of the sealed sheath or catheter, while the sealed sheath or catheter isstationary within the blood vessel. The optical fiber can be relocated within the sheath such that it aligns with unfractured, calcified vascular tissue at a second location.

[0103] In step 1140, the method 1100 controlling the light source to provide light (e.g., UV laser light) to the laser catheter.

[0104] In step 1145, the method 1100 includes emitting shockwaves or pressure waves into the walls of the blood vessel. These shockwaves are a consequence of the laser light interacting with the pressure wave fluid or photoreactive fluid, and are transmitted laterally / radially from the sheath via the acoustically transparent windows. The shockwaves or pressure waves can be used to fracture calcifications embedded in the vessel wall at the second location.

[0105] In step 1150, the method 1100 includes removing the intravascular laser lithotripsy catheter from the blood vessel by moving the guidewire in the opposite direction (relative to the direction of movement in step 1110) over the guidewire.

[0106] In step 1155, the method 1100 includes inserting additional therapy device(s) inserted into the blood vessel by guiding them over the guidewire. Such additional therapy devices may for example include balloon catheters or stents.

[0107] In step 1170, the method 1100 includes performing additional therapy using the additional therapy device(s). Such additional therapy may for example include balloon angioplasty and / or stent placement to dilate the vessel at the location of the fractured calcifications.

[0108] In step 1165, the method 1100 includes removing the additional therapy device(s) from the blood vessel, along with the guidewire. The method is now complete.

[0109] It is noted that steps 1125 and 1140 are, or can be, performed automatically by the console 130 (see Figure 1), whereas steps 1110, 1115, 1120, 1130, 1135 1145, 1150, 1155, 1160, and 1165 are consequences of the automatic steps or are at least partially manual steps that are performed by a clinician operating the intravascular treatment system 100 and intravascular laser lithotripsy catheter 102.

[0110] It is noted that flow diagrams are provided herein for exemplary purposes; a person of ordinary skill in the art will recognize myriad variations that nonetheless fall within the scope of the present disclosure. For example, the logic of flow diagrams may be shown as sequential. However, similar logic could be parallel, massively parallel, object oriented, real-time, event-driven, cellular automaton, or otherwise, while accomplishing the same or similar functions. In order to perform the methods described herein, a processor may divide one or more of the steps described herein into a plurality of machine instructions and mayexecute these instructions at the rate of several hundred, several thousand, several million, or several billion per second, in a single processor or across a plurality of processors.

[0111] Figure 13 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of blood vessel 1200 undergoing treatment by an example intravascular laser lithotripsy catheter 102, in accordance with at least one aspect of the present disclosure. Visible are the flexible elongate member 115, guidewire 118, photoreactive fluid 410, reaction chamber 320, optical fiber 105, acoustic windows 330, and calcifications 1260. In the example shown in Figure 13, the intravascular laser lithotripsy catheter 102 is emitting shockwaves or pressure waves 440 in a radial direction, toward the vessel walls 1210. These shockwaves or pressure waves 440 can fracture the calcifications 1260 that are embedded in the soft tissue of the vessel walls 1210, without damaging the soft tissue of the vessel walls 1210.

[0112] Figure 14 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of blood vessel 1200 undergoing treatment by an example intravascular laser lithotripsy catheter 102, in accordance with at least one aspect of the present disclosure. Visible are the flexible elongate member 115, guidewire 118, photoreactive fluid 410, reaction chamber 320, optical fiber 105, acoustic windows 330, and calcifications 1260. In the example shown in Figure 14, the solid calcification 1260 has been partially converted to fractured calcification 1460 by the shockwaves or pressure waves 440 as the optical fiber 105 is pulled back (e.g., pulled in a proximal direction) through the stenosis. Solid calcifications 1260 are generally resistant to dilation by balloon catheters or stents. However, fractured calcifications 1560 tend to be well retained by the soft tissue of the vessel wall, and yet capable of dilation.

[0113] Figure 15 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of blood vessel 1200 after treatment by an intravascular laser lithotripsy catheter, in accordance with at least one aspect of the present disclosure. Visible are the vessel walls 1210, lumen 1220, and a normal diameter Dnormai. Following treatment by the intravascular laser lithotripsy catheter, the stenosis 1240 now has a diameter Dtreated, which is leSS than Dnormai.

[0114] Figure 16 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of blood vessel 1200 after treatment by an intravascular laser lithotripsy catheter, in accordance with at least one aspect of the present disclosure. In the example shown in Figure 16, a balloon catheter 1620 has been advanced along the guidewire and then inserted into the stenosis 1240 in order to dilate the blood vessel 1200 at the location of thestenosis 1240. Since the solid calcification has been converted into fractured calcification 1560, the stenosis 1240 is now capable of being dilated / expanded by treatment devices such as the balloon catheter 1620.

[0115] Figure 17 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of blood vessel 1200 after treatment by an intravascular laser lithotripsy catheter and a balloon catheter, in accordance with at least one aspect of the present disclosure. Following treatment with the balloon catheter, the stenosis 1240 has been expanded to a diameter DeXpanded, which is greater than the diameter Dtreated (see Figure 15), and may be equal to or comparable to DnOrmai. In some cases, treatment of the stenosis may now be complete. In other cases, a stent may be placed, or other interventions may be taken, to ensure the blood vessel 1200 maintains a healthy diameter.

[0116] Figure 18 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of blood vessel 1200 undergoing treatment by an example intravascular laser lithotripsy catheter 102, in accordance with at least one aspect of the present disclosure. Visible are the flexible elongate member 115, guidewire 118, photoreactive fluid 410, reaction chamber 320, optical fiber 105, acoustic windows 330, and multiple calcifications 1260. In the example shown in Figure 18, the intravascular laser lithotripsy catheter 102 is emitting shockwaves or pressure waves 440 in a radial direction, toward the vessel walls 1210.

[0117] Figure 19 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of blood vessel 1200 undergoing treatment by an example intravascular laser lithotripsy catheter 102, in accordance with at least one aspect of the present disclosure. Visible are the flexible elongate member 115, guidewire 118, photoreactive fluid 410, reaction chamber 320, optical fiber 105, acoustic windows 330, and calcifications 1260. In the example shown in Figure 19, a first region of solid calcifications 1260 has been converted to fractured calcification 1460 by the shockwaves or pressure waves 440 as the optical fiber 105 is pulled back (e.g., pulled in a proximal direction 1270) through the stenosis. The optical fiber 105 is now being pulled further in the proximal direction 1270 toward an untreated region of solid calcification 1260.

[0118] Figure 20 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of blood vessel 1200 undergoing treatment by an example intravascular laser lithotripsy catheter 102, in accordance with at least one aspect of the present disclosure. Visible are the flexible elongate member 115, guidewire 118, photoreactive fluid 410, reaction chamber 320, optical fiber 105, acoustic windows 330, fractured calcifications 1460,and solid calcifications 1260. In the example shown in Figure 20, the intravascular laser lithotripsy catheter 102 is emitting shockwaves or pressure waves 440 in a radial direction, toward the vessel walls 1210 at the location of the untreated, solid calcifications 1260, while being pulled backward in the proximal direction 1270.

[0119] Figure 21 is a schematic, diagrammatic, longitudinal cross-sectional view of at least a portion of blood vessel 1200 undergoing treatment by an example intravascular laser lithotripsy catheter 102, in accordance with at least one aspect of the present disclosure. Visible are the flexible elongate member 115, guidewire 118, photoreactive fluid 410, reaction chamber 320, optical fiber 105, acoustic windows 330, and fractured calcifications 1460. In the example shown in Figure 21, both regions of solid calcifications have now been converted to fractured calcification 1460 by the shockwaves or pressure waves 440 as the optical fiber 105 is pulled back (e.g., pulled in a proximal direction 1270) through the stenosis. If necessary, the optical fiber 105 can now be pulled further in the proximal direction 1270 to treat additional regions of solid calcification 1260, or else the entire intravascular laser lithotripsy catheter 102 can be removed from the patient if the lithotripsy portion of the procedure is complete.

[0120] In some aspects, the intravascular laser lithotripsy catheter can emit one pulse or beam (e.g., a continuous pulse / beam) or a series of pulses or beams (e.g., multiple separate pulses / beams) while the optical fiber is moving (e.g., from the position shown in Fig. 13 to the position shown in Fig. 14). In some aspects, the intravascular laser lithotripsy catheter can emit one pulse or beam (e.g., a continuous pulse / beam) or a series of pulses or beams (e.g., multiple separate pulses / beams) while positioned at discrete locations (e.g., the position shown in Fig. 18, the position shown in Fig. 20, etc.).

[0121] The shockwaves or pressure waves 440 are generated based on light emitted by the optical fiber. The light emitted by the optical fiber at a given location can be referred to as beam(s) or pulse(s) of light. For example, a first beam can be the light emitted by the optical fiber to cause the shockwaves or pressure waves 440 at the location shown in Figure13 or Figure 18. For example, a second beam can be the portion of light emitted by the optical fiber to cause the shockwaves or pressure waves 440 at the locations shown in Figure14 or Figure 20. In general, the beam(s) or pulse(s) of light can refer to the portion of light emitted by the optical fiber, e.g., at a given location or at a given time, whether a continuous pulse / beam is emitted or multiple separate pulses / beams are emitted.

[0122] Figure 22 is a schematic diagram of a processor circuit 2250, in accordance with at least one aspect of the present disclosure. The processor circuit 2250 may be implementedin the intravascular treatment system 100, the 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, as necessary to implement the method. As shown, the processor circuit 2250 may include a processor 2260, a memory 2264, and a communication module 2268. These elements may be in direct or indirect communication with each other, for example via one or more buses.

[0123] The processor 2260 may include a central processing unit (CPU), a digital signal processor (DSP), an ASIC, a controller, or any combination of general-purpose computing devices, reduced instruction set computing (RISC) devices, application-specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or other related logic devices, including mechanical and quantum computers. The processor 2260 may also comprise another hardware device, a firmware device, or any combination thereof configured to perform the operations described herein. The processor 2260 may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[0124] The memory 2264 may include a cache memory (e.g., a cache memory of the processor 2260), random access memory (RAM), magnetoresistive RAM (MRAM), readonly 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 device, hard disk drives, other forms of volatile and non-volatile memory, or a combination of different types of memory. In an aspect, the memory 2264 includes a non-transitory computer-readable medium. The memory 2264 may store instructions 2266. The instructions 2266 may include instructions that, when executed by the processor 2260, cause the processor 2260 to perform the operations described herein. Instructions 2266 may also be referred to as code. The terms “instructions” and “code” should be interpreted broadly to include any type of computer-readable statement(s). For example, the terms “instructions” and “code” may refer to one or more programs, routines, sub-routines, functions, procedures, etc. “Instructions” and “code” may include a single computer-readable statement or many computer-readable statements.

[0125] The communication module 2268 can include any electronic circuitry and / or logic circuitry to facilitate direct or indirect communication of data between the processor circuit 2250, and other processors or devices. In that regard, the communication module 2268 can be an input / output (I / O) device. In some instances, the communication module 2268facilitates direct or indirect communication between various elements of the processor circuit 2250 and / or the system 100. The communication module 2268 may communicate within the processor circuit 2250 through numerous methods or protocols. Serial communication protocols may include but are not limited to United States Serial Protocol Interface (US SPI), Inter-Integrated Circuit (I2C), Recommended Standard 232 (RS-232), RS-485, Controller Area Network (CAN), Ethernet, Aeronautical Radio, Incorporated 429 (ARINC 429), MODBUS, Military Standard 1553 (MIL-STD-1553), or any other suitable method or protocol. Parallel protocols include but are not limited to Industry Standard Architecture (ISA), Advanced Technology Attachment (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 communications may be bridged by a Universal Asynchronous Receiver Transmitter (UART), Universal Synchronous Receiver Transmitter (USART), or other appropriate subsystem.

[0126] External communication (including but not limited to software updates, firmware updates, preset sharing between the processor and central server, or readings from the pressure gauge) may be accomplished using any suitable wireless or wired communication technology, such as a cable interface such as a universal serial bus (USB), micro USB, Lightning, or FireWire interface, Bluetooth, Wi-Fi, ZigBee, Li-Fi, or cellular data connections such as 2G / GSM (global system for mobiles) , 3G / UMTS (universal mobile telecommunications system), 4G, long term evolution (LTE), WiMax, or 5G. For example, a Bluetooth Low Energy (BLE) radio can be used to establish connectivity with a cloud service, for transmission of data, and for receipt of software patches. The controller may be configured to communicate with a remote server, or a local device such as a laptop, tablet, or handheld device, or may include a display capable of showing status variables and other information. Information may also be transferred on physical media such as a USB flash drive or memory stick.

[0127] As will be readily appreciated by those having ordinary skill in the art after becoming familiar with the teachings herein, the intravascular laser lithotripsy catheter advantageously provides a capability to both perform laser atherectomy and also fracture calcified vascular stenoses (including those in peripheral and coronary veins and arteries), without requiring a laser catheter to be moved 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. Theintravascular laser lithotripsy catheter can be used in the field of cardiovascular procedures to treat chronic total occlusions (CTOs) with moderate to severe calcified lesions.

[0128] In some aspects, the optical fiber of the intravascular laser lithotripsy catheter can be seen through the acoustic window is detectable.

[0129] A number of variations are possible on the examples and aspects described above. For example, the intravascular laser lithotripsy catheter could be used not only in arteries, but also in veins and other body lumens, including without limitation those of the liver, kidneys, stomach, gall bladder, lymphatic system, or otherwise. The system may employ other types of lenses, light sources, or fluids than those described herein, without departing from the spirit of the present disclosure. The intravascular laser lithotripsy catheter could be used in other body lumens where there is clinical benefit in a shockwave, pressure wave, or vibration.

[0130] Accordingly, the logical operations making up the aspects of the technology described herein are referred to variously as operations, steps, objects, elements, components, or modules. Furthermore, it should be understood that these may occur, or be performed or arranged, in any order, unless explicitly claimed otherwise or a specific order is inherently necessitated by the claim language.

[0131] All directional references e.g., upper, lower, inner, outer, upward, downward, left, right, lateral, front, back, top, bottom, above, below, vertical, horizontal, clockwise, counterclockwise, proximal, and distal are only used for identification purposes to aid the reader’s understanding of the claimed subject matter, and do not create limitations, particularly as to the position, orientation, or use of the intravascular laser lithotripsy catheter. Connection references, e.g., attached, coupled, connected, joined, or “in communication with” are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily imply that two elements are directly connected and in fixed relation to each other. The term “or” shall be interpreted to mean “and / or” rather than “exclusive or.” The word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. Unless otherwise noted in the claims, stated values shall be interpreted as illustrative only and shall not be taken to be limiting.

[0132] The above 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 certain degree of particularity, or with reference to one or moreindividual aspects, those skilled in the art could make numerous alterations to the disclosed aspects without departing from the spirit or scope of the claimed subject matter. Still other aspects are contemplated. It is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative only of particular aspects and not limiting. Changes in detail or structure may be made without departing from the basic elements of the subject matter as defined in the following claims.

Claims

CLAIMSWhat is claimed is:

1. An intraluminal device for delivering pressure waves, the device comprising: a flexible elongate member configured for positioning within a body lumen 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 translated longitudinally within the outer sheath; wherein, when the chamber is filled with a photoreactive fluid, a first beam of light emitted by the optical fiber is configured to cause the photoreactive fluid to generate a first set of pressure waves that is delivered to a first location of the body lumen via the sealed acoustic window, wherein the sealed acoustic window and the sealed distal end prevent the photoreactive fluid from entering the body lumen.

2. The intraluminal device of claim 1, wherein, after the optical fiber is moved to a second location of the body lumen, a second beam of light emitted by the optical fiber is configured to cause the photoreactive fluid to generate a second set of pressure waves that is delivered to the second location of the body lumen via the sealed acoustic window.

3. The intraluminal device of 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 intraluminal device of claim 1, wherein the sealed acoustic window is disposed radially outward from the chamber.

5. The intraluminal device of claim 1, wherein the chamber is disposed distal of a distal end of the optical fiber and proximal of the sealed distal end of the outer sheath.

6. The intraluminal device of claim 1,wherein the outer sheath comprises a fluid-bearing lumen in fluid communication with the chamber, and wherein the chamber is configured to be filled with the photoreactive fluid via the fluid-bearing lumen.

7. The intraluminal device of claim 1, wherein the photoreactive fluid comprising an X- ray contrast fluid.

8. The intraluminal device of claim 1, wherein the first beam of light comprises ultraviolet light.

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

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

11. The intraluminal device of claim 1, further comprising a reinforcement disposed within at least one of the sealed acoustic window or the outer sheath.

12. The intraluminal device of claim 11, wherein the reinforcement comprises a coil, a braid, or a hypotube.

13. The intraluminal device of claim 1, further comprising a plurality of optical fibers.

14. The intraluminal device of claim 1, further comprising: a telescoping inner member coupled to the optical fiber; and a telescoping outer member coupled to the outer sheath, such that, when the telescoping outer member is stationary and the telescoping inner member is translated longitudinally with respect to the telescoping outer member, the optical fiber is translated longitudinally within the outer sheath.

15. The intraluminal device of claim 1, wherein the chamber comprises a volume inside the outer sheath where a reaction between the first beam of light and the photoreactive fluid occurs to generate the first set of pressure waves.

16. An apparatus, comprising: an intravascular lithotripsy catheter configured to be positioned within a blood vessel and comprising: an outer sheath comprising a sealed distal end, a reaction chamber configured to be filled with a photoreactive fluid, and a sealed acoustic window; an optical fiber configured to be coupled to a laser light source; a telescoping inner member coupled to the optical fiber; and a telescoping outer member coupled to the outer sheath, wherein, when the telescoping outer member is stationary and the telescoping inner member is translated longitudinally with respect to the telescoping outer member, the optical fiber is configured to be translated longitudinally within the outer sheath from a first longitudinal location and a second longitudinal location, wherein, when the optical fiber is at the first longitudinal location and when the optical fiber is at the second longitudinal location, laser light emitted by the optical fiber is configured to cause the photoreactive fluid to generate pressure waves that are delivered 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.

Images