Endovascular lithotripsy

Abstract

The medical device may include an elongated body having a distal elongated body portion and a central longitudinal axis. The medical device may include a balloon positioned along the distal elongated body portion. The balloon may be configured to receive fluid for inflating the balloon so that the outer balloon surface contacts a calcified lesion in the patient's vascular system. The medical device may include one or more pressure wave emitters positioned along the central longitudinal axis of the elongated body. One or more pressure wave emitters may be configured to propagate at least one pressure wave through the fluid to fragment the calcified lesion. At least one pressure wave emitter may include an optical fiber configured to transmit laser energy into the balloon. The laser energy may be configured to generate cavitation bubbles in the fluid.

Description

Technical Field

[0001] (Cross - reference to related applications) The entire content of the following application is incorporated herein by reference. U.S. Patent Application No. 18 / 322,562, titled "INTRAVASCULAR LITHOTRIPSY", filed on May 23, 2023.

Background Art

[0002] Technical Field This disclosure relates to the treatment of calcified plaque lesions in a patient's vascular system.

[0003] Description of Related Art During an intravascular lithotripsy (IVL) procedure, a clinician uses a catheter configured to disrupt calcified plaque lesions within a patient's vascular system. Some such methods involve creating and rapidly collapsing cavitation bubbles to create shock waves that cause this disruption of the calcification.

Summary of the Invention

[0004] This disclosure describes systems and techniques for generating and directing energy to create cavitation bubbles to fragment and / or disrupt calcified lesions within a patient's vascular system. For illustrative purposes, the techniques herein are mainly described with respect to laser - based systems and their respective uses, such as coronary vascular uses. However, it should be understood that the techniques described herein are equally applicable to similar systems based on other forms of energy, such as electrically - based systems, and their respective uses, such as peripheral treatment uses, except as explicitly stated below.

[0005] In some embodiments, the medical device (see, for example, medical device 12 shown in Figure 1) includes an elongated body (see, for example, elongated body 302 shown in Figure 3) having a distal elongated body portion (see, for example, distal elongated body portion 306 shown in Figure 3) and a central longitudinal axis (see, for example, central longitudinal axis 308 shown in Figure 3). According to some embodiments, the medical device includes a balloon (see, for example, balloon 204 shown in Figure 2) positioned along the distal elongated body portion, the balloon having an internal balloon surface (see, for example, internal balloon surface 702 shown in Figure 7A) and an external balloon surface (see, for example, external balloon surface 704 shown in Figure 7B), and is configured to receive a fluid (see, for example, fluid 212 shown in Figure 2) to inflate the balloon, thereby causing the external balloon surface to contact a calcified lesion (see, for example, calcified lesion 50 shown in Figure 1) in the vascular system of a patient (see, for example, patient 20 shown in Figure 1). The medical device may include one or more pressure wave emitters (see, for example, pressure wave emitter 206 as shown in Figure 2) positioned along the central longitudinal axis of an elongated body within a balloon, and the one or more pressure wave emitters are configured to propagate at least one pressure wave through the fluid to fragment calcified lesions. In some embodiments, at least one of the pressure wave emitters includes an optical fiber (see, for example, optical fiber 802 as shown in Figure 8) configured to transmit laser energy into the balloon. According to some embodiments, the laser energy is configured to generate at least one pressure wave by creating cavitation bubbles in the fluid upon contact with the fluid.

[0006] The features and advantages of the present invention described herein, as well as other features and advantages, will become apparent from the following more specific description relating to preferred embodiments of the invention, the accompanying drawings, and the claims. [Brief explanation of the drawing]

[0007] These and other features, embodiments, and advantages are described below with reference to the drawings, which are intended to illustrate the invention and not limit it. In the drawings, similar letters consistently indicate corresponding features throughout similar embodiments. [Figure 1] This diagram illustrates an example of an endovascular lithotripsy (IVL) system that may appear when inserted into a patient's vascular system. [Figure 2A] Two diagrams illustrating medical devices within or near calcified lesions in blood vessels are presented as examples. [Figure 2B] Two diagrams illustrating medical devices within or near calcified lesions in blood vessels are presented as examples. [Figure 3] This is a diagram illustrating the IVL system. [Figure 4] This section illustrates an example of the IVL system shown in Figure 3, which may appear in the usage scenario. [Figure 5] We will illustrate block diagrams of laser energy source systems, such as the generator shown in Figure 1, based on several embodiments. [Figure 6] An illustrative side view of an exemplary IVL catheter is shown, including an IVL balloon at the distal end and a connector for connecting the IVL catheter to a generator. [Figure 7A] Let's illustrate this with two cross-sectional views of the medical device shown in Figure 6. [Figure 7B] Let's illustrate this with two cross-sectional views of the medical device shown in Figure 6. [Figure 8] Figure 6 illustrates the position of the distal fiber end of the optical fiber using an IVL catheter, along with a perspective view of the IVL balloon. [Figure 9A] Several examples illustrate perspective views of a portion of an IVL catheter at the distal fiber ends of two optical fibers. [Figure 9B] Several examples illustrate perspective views of a portion of an IVL catheter at the distal fiber ends of two optical fibers. [Figure 10A] The diagram illustrates an IVL device in which the distal fiber end of an optical fiber is held in place with or without the use of targets of various profile shapes. [Figure 10B] The diagram illustrates an IVL device in which the distal fiber end of an optical fiber is held in place with or without the use of targets of various profile shapes. [Figure 10C] The diagram illustrates an IVL device in which the distal fiber end of an optical fiber is held in place with or without the use of targets of various profile shapes. [Figure 10D] The diagram illustrates an IVL device in which the distal fiber end of an optical fiber is held in place with or without the use of targets of various profile shapes. [Figure 11A] As illustrated in Figures 10A to 10D, profile diagrams of three possible configurations of a fiber positioner for holding an optical fiber in place are illustrated. [Figure 11B] As illustrated in Figures 10A to 10D, profile diagrams of three possible configurations of a fiber positioner for holding an optical fiber in place are illustrated. [Figure 11C] As illustrated in Figures 10A to 10D, profile diagrams of three possible configurations of a fiber positioner for holding an optical fiber in place are illustrated. [Figure 11D] As illustrated in Figures 10A to 10D, profile diagrams of three possible configurations of a fiber positioner for holding an optical fiber in place are illustrated. [Figure 12] The diagram illustrates, in several embodiments, two optical fibers that traverse the IVL catheter along the lumen of a guidewire and terminate inside the IVL balloon. [Figure 13] This example illustrates a profile diagram of a shroud designed to protect a balloon from optical fibers. [Figure 14A] An example illustrates a perspective view of a single optical fiber moving along an IVL catheter and the cavitation bubbles formed at the distal fiber end. [Figure 14B] An example illustrates a perspective view of a single optical fiber moving along an IVL catheter and the cavitation bubbles formed at the distal fiber end. [Figure 15] Illustrate cross-sectional views of the elongated body and the optical fiber of FIGS. 14A and 14B. [Figure 16A] Illustrate a perspective view of a single optical fiber moving along an IVL catheter having a notch cut into the optical fiber. [Figure 16B] Illustrate a perspective view of a single optical fiber moving along an IVL catheter having a notch cut into the optical fiber. [Figure 17] Illustrate cross-sectional views of the elongated body and the optical fiber of FIGS. 16A and 16B. [Figure 18A] Illustrate various perspective views of an embodiment of a plurality of optical fibers of an IVL catheter. [Figure 18B] Illustrate various perspective views of an embodiment of a plurality of optical fibers of an IVL catheter. [Figure 18C] Illustrate various perspective views of an embodiment of a plurality of optical fibers of an IVL catheter. [Figure 19A] Illustrate side views of various distal fiber ends of an optical fiber as may be provided on an IVL catheter. [Figure 19B] Illustrate side views of various distal fiber ends of an optical fiber as may be provided on an IVL catheter. [Figure 19C] Illustrate side views of various distal fiber ends of an optical fiber as may be provided on an IVL catheter. [Figure 19D] Illustrate side views of various distal fiber ends of an optical fiber as may be provided on an IVL catheter. [Figure 19E] Illustrate side views of various distal fiber ends of an optical fiber as may be provided on an IVL catheter. [Figure 19F] Illustrate side views of various distal fiber ends of an optical fiber as may be provided on an IVL catheter. [Figure 19G] Illustrate side views of various distal fiber ends of an optical fiber as may be provided on an IVL catheter. [Figure 19H]This illustrates side views of various distal fiber ends of optical fibers, which may be used in IVL catheters. [Figure 20] This example illustrates a flowchart showing how to generate cavitation bubbles within a balloon catheter. [Figure 21] This example illustrates a flowchart showing how to generate cavitation bubbles within blood vessels. [Figure 22] Let's illustrate another side view of an exemplary IVL system. [Figure 23A] Diagrams illustrating IVL devices including a movable fiber positioner, based on several embodiments, are provided. [Figure 23B] Diagrams illustrating IVL devices including a movable fiber positioner, based on several embodiments, are provided. [Figure 23C] Diagrams illustrating IVL devices including a movable fiber positioner, based on several embodiments, are provided. [Figure 24] Let's illustrate this with a cross-sectional view of the IVL device shown in Figure 23A. [Figure 25] Figures 23B and 23C illustrate the cross-sectional views of the IVL device. [Figure 26] An example diagram of an IVL device in which the distal fiber end of an optical fiber is held in place is provided. [Figure 27A] Various examples of cross-sections of the IVL device shown in Figure 26 are illustrated. [Figure 27B] Various examples of cross-sections of the IVL device shown in Figure 26 are illustrated. [Figure 27C] Various examples of cross-sections of the IVL device shown in Figure 26 are illustrated. [Figure 27D] Various examples of cross-sections of the IVL device shown in Figure 26 are illustrated. [Figure 27E] Various examples of cross-sections of the IVL device shown in Figure 26 are illustrated. [Figure 28A] An example diagram of an IVL device including the fiber positioner lumen is provided. [Figure 28B] An example diagram of an IVL device including the fiber positioner lumen is provided. [Figure 29]Figures 28A and 28B illustrate the cross-sectional views of the IVL device. [Figure 30] An example diagram of an IVL device including a track is provided. [Figure 31] Figure 30 illustrates the cross-sectional view of the IVL device. [Figure 32] Perspective views of the controller are illustrated in several embodiments. [Figure 33] An additional illustrative perspective view of a controller is provided. [Figure 34] This section illustrates various exemplary controller bottom views, including those with optical fiber mobility capabilities. [Figure 35] This section illustrates various exemplary controller bottom views, including those with optical fiber mobility capabilities. [Figure 36] This section illustrates various exemplary controller bottom views, including those with optical fiber mobility capabilities. [Figure 37] This section illustrates various exemplary controller bottom views, including those with optical fiber mobility capabilities. [Figure 38] This section illustrates various exemplary controller bottom views, including those with optical fiber mobility capabilities. [Modes for carrying out the invention]

[0008] Specific embodiments are disclosed below, but the subject matter of the present invention extends beyond the specifically disclosed embodiments to alternative embodiments and / or uses, as well as their modifications and equivalents. Therefore, the claims appended herein are not limited by any of the specific examples described below. For example, in any method or process disclosed herein, the action or operation of the method or process may be performed in any preferred order, and is not necessarily limited to any specific disclosed order. Various operations may be described sequentially as a number of separate operations in a manner that may be helpful in understanding the specific embodiments, but the order of description should not be interpreted as implying that these operations are order-dependent. Additionally, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components.

[0009] For the purpose of comparing various examples, certain aspects and advantages of these examples are described. Not all such aspects or advantages are necessarily achieved by any particular example. Therefore, for example, various examples may be performed in a manner that achieves or optimizes one advantage or group of advantages taught herein, without necessarily achieving other aspects or advantages that may be taught or suggested herein.

[0010] During endovascular lithotripsy (IVL) procedures, clinicians use the formation and subsequent rupture of cavitation bubbles to generate high-energy pressure waves, which then fragment calcified plaque lesions within the patient's vascular system. Typical IVL procedures involve generating shock waves through an electrode emitter or electrode pair. Such systems have a larger crossover profile and can increase manufacturing complexity.

[0011] Conventional IVL catheters also lack the ability to finely control the directionality of the delivered energy. The use of optical fibers to create cavitation bubbles can help correct these disadvantages of prior art devices, as well as increase the power delivered, which can improve the effectiveness of treatment, improve the consistency of energy delivery, increase the overall durability of the IVL catheter, and reduce manufacturing costs due to its lower complexity.

[0012] This disclosure describes systems and techniques for generating and directing high-energy intravascular pressure waves for fragmentation and / or decomposition of calcified lesions within a patient's vascular system. For illustrative purposes, the techniques described herein are primarily described in relation to optical (e.g., laser) based systems and their respective applications, such as coronary vascular applications. However, it is understood that the techniques described herein may also be assumed to be applicable to similar systems based on other forms of energy, such as electrical based systems, and their respective applications, such as peripheral therapeutic applications, unless explicitly stated below. Additionally, while the treatment site is described throughout this specification as including calcified lesions, it is understood that this disclosure also enables the treatment of restenotic lesions.

[0013] The systems described herein generally include an energy source, an IVL catheter having a distal IVL device, and an optical fiber. In some embodiments, the system includes an intervention balloon. During a lesion disruption procedure, the clinician may advance the intervention balloon to a targeted treatment site within the patient's vascular system and inflate the balloon with an expansion fluid, such as a saline / contrast fluid mixture, until the balloon makes contact with at least a portion of the local vessel wall. It is understood that the saline / contrast fluid mixture has a viscosity suitable for creating cavitation bubbles through the introduction of electrical or optical energy. Since the saline / contrast fluid mixture is often mixed at the time of treatment, the ratio between saline and contrast fluid may vary. Nevertheless, laser-based energy delivery may be relatively insensitive to these variations. The clinician may then activate an energy generator and instruct the catheter to generate cavitation bubbles in the fluid-filled balloon and propagate a high-energy pressure wave through the balloon and the calcified lesion. A second pressure wave may also arise from the subsequent disruption of fluid cavitation, further destabilizing the internal structure of the lesion.

[0014] In embodiments that do not include an intervention balloon, the saline / contrast fluid mixture is released into the patient's vascular system near the treatment site, replacing the blood in the local area. Once this saline / contrast fluid mixture has at least partially replaced the blood in this area, the clinician may activate an energy generator to cause cavitation bubbles in the area of ​​the saline / contrast fluid mixture via a catheter, propagating a high-energy pressure wave through this area into the calcified lesion.

[0015] Additional embodiments, both with and without an intervention balloon, involve introducing a photosensitive agent into a saline / contrast fluid mixture. This photosensitive agent may provide a target for the energy source and allow for better control over where cavitation bubbles form within the intervention balloon and / or within the saline / contrast fluid mixture replacing blood in the local area.

[0016] As used herein, “superheating” means heating a liquid to a temperature above its boiling point under pressure without vaporization. In some embodiments, the devices disclosed herein do not superheat the fluid in the balloon to form cavitation bubbles. In alternative embodiments, the devices disclosed herein superheat the fluid in the balloon to form these cavitation bubbles.

[0017] Figure 1 illustrates a diagram of an endovascular lithotripsy (IVL) system 10 as it may appear when inserted into the patient's vascular system. The IVL system 10 may include a medical device 12, possibly including an intervention balloon, as depicted in later figures. During the lesion decomposition procedure, the clinician may advance the medical device through an access point 14 in the patient 20, such as the femoral artery or common femoral artery, as depicted in Figure 1. Other access points may include the radial artery, tibial artery, pedal artery, axial artery, and peroneal artery. The medical device 12 may then be advanced through the patient 20's vascular system until it reaches a vessel 30 encompassing the treatment area 40. For IVL, the treatment area may include a calcified lesion 50. Figures 2A and 2B show enlarged views of two embodiments of the IVL system located within or adjacent to the treatment area 40, which includes the calcified lesion 50.

[0018] Figure 2A illustrates a diagram of a medical device 12 within a treatment area 40 containing a calcified lesion 50 within a blood vessel 30. In this embodiment, the medical device 12 includes a balloon 204. During IVL treatment, the clinician may inflate the balloon 204 to make physical contact with at least a portion of the calcified lesion 50 within the treatment area 40 and the wall of the blood vessel 30. This inflation of the balloon 204 may involve using a saline / contrast fluid mixture to propagate a pressure wave or “shock wave” when heated by the laser. This saline / contrast fluid solution may be any percentage ratio, as no discernible difference was observed during testing. While any saline / contrast fluid solution may be used, it may be desirable to include at least a small percentage of contrast fluid in the aforementioned solution, as saline does not appear under fluoroscopy and therefore does not cause inflation or inflation-related problems to the operator. As discussed in Figures 10A and 10B, laser energies of certain wavelengths may be capable of overheating the saline / contrast fluid mixture without assistance (Figure 10A). Furthermore, other wavelengths may require a target block that is less absorbent in the saline / contrast fluid mixture and overheats to cause the development of a pressure wave.

[0019] Figure 2A also shows a central lumen 208 located within an elongated body (hereinafter 302). Along the elongated body 302 are pressure wave emitters 206. As shown in Figures 2A and 2B, five pressure wave emitters (206a, 206b, 206c, 206d, and 206e) are present within the medical device 12. Although five pressure wave emitters 206 are illustrated in Figures 2A and 2B, the array of emitters 206 in the medical device 12 can include from just one individual emitter unit 206 to the maximum number of emitter units 206 that can be reasonably fitted within the balloon 204. Note that an individual emitter unit 206 is also referred to as “emitter” 206 throughout this disclosure (for example, referring to the entire emitter unit 206).

[0020] Figure 2B illustrates a diagram of a medical device 12 adjacent to a treatment area 40 containing a calcified lesion 50 within a blood vessel 30. The medical device 12, balloon 204, and pressure wave emitter 206 may be similar to those described in Figure 2A. However, the central lumen 208 of the elongated body 302 in Figure 2B is shown as a place for deploying or injecting a fluid 212 into the treatment area 40. This fluid 212 can replace the blood in the treatment area 40 before inserting the medical device 12 into the treatment area 40, facilitating the expansion of the balloon 204 and increasing the effectiveness of the IVL procedure.

[0021] Figure 3 illustrates an IVL system 10. As shown in Figure 3, the IVL system 10 may include at least an energy generator 310 and an elongated body 302 detachably coupled to the energy generator 310 via an electrical connector 312 or the like. The elongated body 302 may include a medical device 12 positioned at a distal elongated body portion 306. In some embodiments, the elongated body 302 is configured to travel through the patient's 20 winding vascular system toward a target treatment site 40, for example, a calcified plaque lesion 50 within a blood vessel 30.

[0022] Although the term “elongated body” is used throughout this specification, it is understood that the elongated body may refer to a catheter, such as an IVL catheter. Additionally, in the description of Figure 3, connector 312 is described as an electrical connector 312, but it is understood that connector 312 may be an optical connector 312. In fact, in some embodiments, the IVL system 10 may not require an electrical connector 312. In these embodiments, the therapy button may be located on the console, and there may be no electrical query for the catheter itself. While an electrical connector 312 may not be required in all embodiments, an optical connector 312 is required to supply laser energy to the catheter.

[0023] As shown in Figure 3, the medical device 12 may include a fluid-inflatable intervention balloon 204 and an array of pressure wave emitters 206, shown but unlabeled due to size constraints, positioned within the balloon 204. The emitter array 206 may include one or more individual emitter units 206. For example, the intervention balloon 204, or a distal elongated body portion 306 passing through it, may define a central longitudinal axis 308, and the emitter units 206 may be distributed longitudinally along the central longitudinal axis 308.

[0024] Each emitter unit 206 is configured to receive energy from the energy generator 310, use the received energy to generate a high-energy pressure wave, and transmit it through the balloon 204 and across the treatment site. As will be further detailed below, the energy generator 310 may generate and transmit energy in the form of electrical energy, optical energy, or a combination thereof. For example, the emitter unit 206 may use the received energy to generate cavitation bubbles 1404 in the fluid inside the balloon 204, and propagate one or more high-energy pressure waves radially outward through the balloon and the calcified lesion.

[0025] In some cases, though not all, a secondary set of high-energy pressure waves may occur following the collapse of the fluid cavitation bubbles 1404 (as shown in Figure 14), further destabilizing the internal structure of the calcified plaque lesion. In some embodiments, one or more emitters 206 include optical-based emitters 206 configured to receive high-energy optical (e.g., optical) signals from the generator 310, such as via one or more optical fibers 802 (as shown in Figure 8), and the optical signals can be directed to trigger initial cavitation. Additionally, one or more emitters 206 may include electrical-based emitters 206 configured to receive electrical energy from the generator 310, such as via one or more conductive wires, generating a spark between a pair of electrodes, thereby triggering initial cavitation.

[0026] In some embodiments, the cooling mechanism functions in conjunction with the energy generator 310. However, the flash lamp system may provide energy to the optical fiber 802 without requiring the aforementioned cooling mechanism. Additionally, a diode system may be used as an alternative to the flash lamp system, which may also not require a cooling mechanism.

[0027] Figure 4 illustrates an embodiment of the IVL system 10 of Figure 3 that may appear in use. A medical post may be provided, if necessary, to facilitate movement of the IVL system 10 between rooms. A power supply 402 may be located near the base of the medical post and connected to a power cord 408 for receiving power from wall power or a generator 310, as well as to an umbilicus for electrical connection to a console 404. As shown in Figure 4, the console 404 allows a user, such as a clinician, to operate the IVL system 10. The elongated body 302 may be connected to the console 404 via a power cable to receive energy from the power supply 402 and transmit that energy to the emitter 206 in the IVL balloon 204. A separate line dedicated to inflating the IVL balloon 204 may also be present.

[0028] According to some embodiments, a detection line 406 is present. The detection line 406 may provide several ways of providing feedback regarding the integrity of individual components within the IVL balloon 204. For example, a safety pressure sensor may be provided. If a sudden drop in pressure is detected, a malfunction such as rupture of the IVL balloon 204 may have occurred. This suggests to the clinician that the procedure should be stopped and the IVL balloon 204 should be immediately and safely retrieved from the patient's vascular system. According to some embodiments, if the pressure sensor within the IVL balloon 204 detects a rupture of the balloon 204, the release of energy through the elongated body 302 may be immediately stopped. It should be understood that the term “stop” may be used to issue an error code to the operator for manual shutdown or automatic system shutdown.

[0029] Additionally, the pressure sensor may be located anywhere within the pressure path, which defines a path starting from the generator and ending at the balloon 204. In some embodiments, the pressure sensor may be located within the generator 310. According to some embodiments, the pressure sensor may be located within a hub, which is an intermediate component connecting the elongated body 302 to the generator 310 (in embodiments including a separate generator 310). The pressure sensor may be located within the elongated body 302. In some embodiments, it is the IVL balloon 204, as described in the previous paragraph. The pressure sensor may be located outside these separate components (generator 310, hub, elongated body 302) but within the pressure path.

[0030] Furthermore, in some embodiments, the pressure sensor may be located anywhere within the IVL system 10, including outside the pressure path described above. This may include a separate device outside the medical device 12, such as an inflation device which is either part of the hub connector or attached to the hub connector. This inflation device may be adjacent to, but outside, the guidewire lumen 208. The pressure sensor may be part of such an inflation device or attached to such an inflation device.

[0031] Additionally, a fiber query mechanism may be present. According to some embodiments, the purpose of the fiber query mechanism is to detect or determine whether at least one of the optical fibers, or optical fiber 802 (see Figure 8), is broken or otherwise severed. This can be achieved by reflecting at least a portion of the energy back to optical fiber 802 when a pulse is emitted, and if this return pulse is disrupted, it indicates to the clinician that something is wrong and that the IVL balloon 204 needs to be retrieved and the problem resolved.

[0032] Figure 5 illustrates block diagrams of laser energy source systems 502 according to several embodiments. As can be seen by the dotted lines enclosing most of the components, the laser energy source system 502 includes an energy source. Power, such as power from a wall, as indicated by the arrow through 120V(IN), can be supplied to a power supply 402 within the energy source. Power supply 402 powers a flash lamp power supply 504 and a central processing unit (CPU) 518. The flash lamp power supply 504 can be controlled by the CPU 518.

[0033] The CPU 518 includes a user interface, which may include tactile buttons and switches, or other means of user communication such as a touchscreen. A power switch 516 is indicated to communicate electronically with the CPU 518, and a push button 520 is also indicated to reset the CPU 518 and initiate therapy when the elongated body 302 is in place. The CPU 518 also controls lamps 514 (On, RDY (Ready), E (Emission), and F (Fault)). The On lamp 514 indicates that the system 502 is turned on. The RDY lamp 514 indicates that the system 502 is connected and ready to activate the laser energy. The E lamp 514 indicates that the laser energy is currently active. The F lamp 514 indicates that a fault has occurred and the system 502 needs to be reset. In the IVL system 10, which includes safety features such as safety pressure sensors as described above, the CPU 518 is located inside the IVL balloon 204 and therefore receives this feedback from a pressure sensor 522 that is located outside the energy source.

[0034] The flash lamp power supply 504 includes a lamp lead 506 that electrically couples the flash lamp power supply 504 to the laser head 508. The laser head 508 communicates electronically with the CPU 518 and is directed to a shutter 510 controlled by it. The shutter 510 is an additional safety device to prevent premature emission of the laser through the elongated body 302. The shutter 510 is commanded by the CPU 518 immediately before triggering the flash lamp that initiates the laser energy. In the case of a laser source such as an excimer laser, the trigger for the shutter 510 may be a high-voltage switch instead of a flash lamp. The shutter 510 separates the laser head 508 from the optical fiber 802, as indicated by the fiber out 512. The optical fiber 802 then travels the length of the elongated body 302 to the treatment site. In the IVL system 10, which includes safety features such as the fiber query mechanism described above, the CPU 518 receives feedback from the optical fiber 802 through the fiber query mechanism 524, as shown in the figure. Since the fiber query mechanism can operate from anywhere along the fiber line (a break somewhere in the line can be detected from anywhere else along the line, as long as detection is performed before the break), the fiber query mechanism 524 is shown as being conveniently located within the energy source.

[0035] Figure 6 illustrates an exemplary side view of an elongated body 302, including an IVL balloon 204 in the distal elongated body portion 306 and a connector 312 for connecting the elongated body 302 to a generator 310. In some embodiments, the elongated body 302 includes an inner shaft and an outer shaft surrounding the inner shaft. The inner shaft may include a guidewire lumen 208 or another type of lumen 208, depending on the clinician's needs.

[0036] As shown in Figure 6, an IVL balloon 204 may be present. The IVL balloon 204 may be inflated with a saline / contrast fluid mixture when the elongated body 302 is advanced to the treatment site. There is at least one emitter inside the IVL balloon 204. As previously described, there may be only a single emitter 206 (as described in Figures 14A, 14B, 16A, and 16B), or there may be multiple emitters 206 (as shown in more detail in Figures 18A, 18B, and 18C).

[0037] In some embodiments, a single emitter, such as an optical fiber, may be cut to create multiple locations for light or signal emission for a laser, allowing a single optical fiber 802 to function as multiple emitters 206. Such embodiments are discussed in more detail in Figures 14A and 14B.

[0038] In the proximal elongated body portion 304, a connection point between the elongated body 302 and the generator 310 can be seen. This connection point may be created by direct coupling of the elongated body 302 to the generator 310, or through an adapter suitable for coupling one end to the elongated body 302 and the other end to the generator 310. In this proximal elongated body portion 304, in embodiments where multiple fibers 802 are used as emitters 206, a fiber bundle may also be present. This fiber bundle is in optical communication with or optically coupled to the generator 310 to provide the laser energy emitted into the fluid-filled IVL balloon 204 to the optical fibers 802.

[0039] As previously disclosed, in some embodiments, the IVL balloon 204 may be absent or unnecessary relative to the elongated body 302. In these embodiments, the inner shaft may include a lumen 208 configured to deliver a saline / contrast fluid mixture to a treatment area of ​​the vascular system. By introducing this saline / contrast fluid mixture, the local blood in this vascular system may be replaced, and thus the energy released by the optical fiber 802 can generate cavitation bubbles 1404 without requiring an external structure such as the IVL balloon 204.

[0040] Figures 7A and 7B illustrate two cross-sectional views of the medical device 12 of Figure 6. Specifically, Figure 7A illustrates a balloon 204 having a metallized coating 706 on its internal balloon surface 702, and Figure 7B illustrates a balloon 204 having a metallized coating 706 on its external balloon surface 704. Both Figures 7A and 7B also show an elongated body 302 and a central lumen 208. The radii and proportions of each feature have been exaggerated to simplify the representation of each independent structure in the drawings.

[0041] The metallized coating 706 may be configured to increase the damage threshold of the balloon 204 due to laser energy. That is, the presence of the metallized coating 706 on either the internal balloon surface 702 or the external balloon surface 704 may increase the balloon 204's resistance to perforation and rupture caused by excessive laser energy. The metallized coating 706 may also provide additional safety in case of balloon failure or deflation. This metallized coating 706 may prevent the optical fiber (802 below) from coming into contact with or penetrating the balloon 204. Without additional safety measures, if the balloon is perforated during the procedure, balloon fragments may be unintentionally left in place and then travel through the patient's blood vessels. Furthermore, this additional measure may facilitate the prevention of undesirable balloon deflation.

[0042] The metallized coating 706 can be produced from aluminum, nickel, chromium, gold, alloys, dielectric reflective coatings, and similar materials. This list of metallized coatings 706 is not exhaustive, and it should be understood that equivalent metallized coatings 706 may be used even if they are not named herein. The metallized coating 706 can be deposited in extremely thin layers. These layers can be as thin as a few microns, making the metallized coating 706 nearly transparent and allowing the thickness of the balloon 204 to be reduced as much as possible while still achieving the advantages listed herein.

[0043] In both Figures 7A and 7B, the metallized coating does not significantly alter the fit or any other balloon properties. The additional thickness added to the balloon 204 may depend on whether the metallized coating 706 is on the internal balloon surface 702 or on the external balloon surface 704. For example, in Figure 7A, the metallized coating 706 can be folded, which can increase the thickness of the balloon 204 by up to twofold. In Figure 7B, the additional layer may be located outside the metallized coating 706 on the external balloon surface 704 to prevent particle migration. This can suggest that the thickness of the balloon 204 can increase by up to sixfold.

[0044] Figure 8 illustrates a perspective view of the IVL balloon 204 and an inset illustrating the position of the distal fiber end (hereinafter referred to as 1402) of the optical fiber 802 by the elongated body 302 of Figure 6. In this embodiment and the following embodiments, any existing optical fiber 802 functions as a pressure wave emitter 206 as detailed in the previous figure. According to the embodiment of Figure 8, the protective sleeve may enclose the inner shaft and / or any existing lumen 208 and protect these surfaces from any energy emission from the distal fiber end 1402 of the optical fiber 802. Although not shown in the figure, the optical fiber 802 may include a toe or blunt feature at its end to prevent accidental perforation of the balloon 204 by the optical fiber 802. It is understood that such a toe or blunt feature does not obstruct the passage of laser energy from the distal fiber end 1402.

[0045] Figures 9A and 9B illustrate perspective views of portions of the elongated body 302 at the distal fiber ends 1402 of two optical fibers 802 in several embodiments. At least one optical fiber 802 may be terminated adjacent to the target 902, at least partially. In the case of shorter wavelength radiation, such as Nd:YAG lasers, the target 902 may provide safety features and components in the formation of cavitation bubbles 1404.

[0046] Regarding safety, the high energy provided by the Nd:YAG laser can cause cavitation, which, if left untreated, can progress into the patient's vascular system. In such a situation, and if the energy level is sufficiently high, this can be harmful to the patient. Target 902 can prevent the energy from exceeding the boundaries of the IVL balloon 204 and / or the effective treatment area when the IVL balloon 204 is not provided.

[0047] With regard to the formation of cavitation bubbles 1404, the target 902 may receive the energy emitted by the optical fiber 802 and begin to heat up. As the target 902 heats up further, cavitation bubbles 1404 may form on the target 902. In this scenario, the wavelength of the laser is not absorbed by the saline / contrast fluid mixture, nor is it intended to be absorbed, but all of the energy is supplied to the target 902, which, due to the subsequent heating of the surrounding saline / contrast fluid mixture, may promote the generation of superheated cavitation bubbles 1404 on the surface of the target 902.

[0048] Figures 10A, 10B, 10C, and 10D show a medical device 12 having an IVL balloon 204 directed toward a target 902, with the distal fiber end 1402 of an optical fiber 802 held in place by a fiber positioner 1002.

[0049] Figure 10A illustrates a side view of a medical device 12 without a target. In this embodiment, the wavelength of energy from the laser is such that the saline / contrast fluid mixture is heated by the laser itself, causing cavitation bubbles to propagate without the need for additional components in the form of a target. In Figures 10B-10D, the saline / contrast fluid mixture is not the intended recipient of the energy, and the target 902 is used to receive the laser energy and heat up, sequentially heating the surrounding saline / contrast fluid mixture and subsequently inducing the propagation of cavitation bubbles; therefore, various other wavelengths of laser energy may be used.

[0050] Figure 10B illustrates a side view of target 902a as a trapezoid with its flat side facing the distal fiber end 1402. Figure 10C shows a side view of target 902b as an elongated octagon, where an angled or inclined surface may be in the path of the optical signal. Figure 10D shows an embodiment of target 902c having a surface facing the fiber that is inclined or angled with respect to the propagation angle of the laser energy. This angled surface may allow cavitation bubbles 1404 to be emitted substantially perpendicular to this propagation angle of the laser energy and toward the calcified lesion.

[0051] In the elongated body 302 shown in Figures 10A, 10B, 10C, and 10D, the optical fiber 802 is locked in place by the fiber positioner 1002. The fiber positioner 1002 ensures that the relationship between the optical fiber 802 and the target 902 is consistent in terms of both the distance from each other and the distance of the distal fiber end 1402 from the central lumen 208.

[0052] According to some embodiments, the fiber can be repositioned within the balloon 204, and thus the distance to the target 902 can be adjusted by the clinician. As illustrated in other figures, this ability to reposition the optical fiber 802 is independent of the target 902 located within the elongated body 302. A sliding mechanism may be included in a handle or control interface coupled to the optical fiber 802, enabling the aforementioned axial movement and control of the optical fiber 802. If the clinician wishes to control each optical fiber 802 located within the elongated body 302 independently, a separate sliding mechanism may be included. If only a single optical fiber 802 is located within the elongated body 302, only a single sliding mechanism may be required. Fiber positioners are shown and illustrated in Figures 11A, 11B, 11C, and 11D.

[0053] Figures 11A, 11B, 11C, and 11D illustrate profile diagrams of three possible configurations of a fiber positioner for holding an optical fiber in place, as depicted in Figures 10A to 10D. Specifically, Figure 11A illustrates a marker band 1102 having an upper component fiber positioner 1002a that holds an optical fiber 802 and has a chamfer at the end where the tip of the optical fiber may seat but not touch. Such a fiber positioner 1002 may be injection molded or extruded.

[0054] Figure 11B illustrates the fiber positioner 1002 of Figure 11A, but without the marker band 1102. This fiber positioner 1002b can also be extruded or injection molded, but because it lacks the marker band 1102, the fiber positioner 1002b can be attached to a pre-fabricated marker band 1102 or another component using an adhesive or the like. The fiber positioner 1002b has a rounded bottom to allow attachment to a circular mechanism such as an elongated body 302, a marker band 1102, or another component.

[0055] Figure 11C illustrates another embodiment of the fiber positioner 1002c. This fiber positioner 1002c has a simpler structure than the fiber positioners in Figures 11A and 11B and does not include multiple holes or a rounded bottom portion. This fiber positioner 1002c may be held in place on the elongated body 302 or may have laser-cut slits in its flared section to allow it to be crimped onto the elongated body 302, the marker band 1102, or another component. Additional implementations include attaching the fiber positioner 1102c to an internal mechanism (i.e., the elongated body 302, the marker band 1102, etc.) via ultraviolet (UV) adhesive, heat shrink, or a shrunk marker band. It is understood that these implementations of attachment may be used in conjunction with the fiber positioner 1002b in Figure 11B. These mountings are not required for the fiber positioner 1002a in Figure 11A, in which case the fiber positioner 1002a and the marker band 1102 are molded together.

[0056] Figure 11D illustrates another embodiment of the fiber positioner 1002, indicated as marker band 1102b. In this embodiment, there are two marker bands 1102, an inner marker band 1102a around the guidewire lumen 208 and an outer marker band 1102b surrounding the inner marker band 1102a, as well as an optional present optical fiber 802. In this way, the inner marker band 1102a separates the optical fiber 802 from the guidewire lumen 208 by a predetermined distance, and the outer marker band 1102b keeps the optical fiber 802 in place.

[0057] Although not shown in Figures 11A to 11D, a flare similar to the shroud shown and described in Figure 13 below may exist in any of Figures 11A to 11D. This flare acts as a safety feature and can help prevent any laser energy from coming into contact with either the balloon surface or the guidewire lumen.

[0058] Figure 12 illustrates, in several embodiments, two optical fibers 802, represented as optical fibers 802a and 802b, which traverse an elongated body 302 along the guidewire lumen 208 and terminate inside the IVL balloon 204. As seen in Figure 12, the optical fiber 802a, shown above the guidewire lumen 208, exhibits an angled distal end. In some embodiments, this angled distal end is angled greater than 114 degrees with respect to the longitudinal axis of the guidewire lumen 208. In other words, if the distal fiber end 1402 moves substantially parallel to the moving vascular system within it, the distal end can be angled greater than 24 degrees with respect to a plane perpendicular to the longitudinal axis of the lumen 208. This angled distal end can facilitate the avoidance of laser energy impacting the outer surface of the guidewire lumen 208. This may help ensure the safety of the guidewire lumen 208, or ensure that all of the laser energy is delivered to the target 902, or both.

[0059] As can be seen in the optical fiber 802b beneath the guidewire lumen 208, the optical fiber 802b may also terminate radially off-center from the guidewire lumen 208. Similar to an angled distal tip, this radially off-center termination of the optical fiber 802b can facilitate the avoidance of laser energy impacting the outer surface of the guidewire lumen 208. The distance at which the optical fiber 802b can exist radially off-center from the guidewire lumen 208 depends on the diameter of the optical fiber, as well as where the optical fiber 802b is able to begin bending. Greater bending of the optical fiber 802b may require a larger balloon 204, which can be problematic for smaller diameter vascular systems.

[0060] Figure 13 illustrates a profile diagram of a shroud 1302 for protecting balloon 204 from optical fiber 802. The shroud 1302 may be a laser-cut nitinol structure coupled to a skirt made of a material such as cloth, polymer, or any other flexible material. The skirt may expand when balloon 204 is inflated. The nitinol structure may include tines with curved ends to provide smooth contact points with balloon 204 and prevent accidental perforation of the aforementioned balloon 204. The skirt may also expand using different mechanisms in a proximal handle of the elongated body 302.

[0061] As used in conjunction with the embodiments in Figures 11A, 11B, 11C, and 11D, the shroud 1302 may be used to protect the balloon 204 from the tip of the optical fiber 802 and prevent accidental puncture of the balloon 204. The shroud 1302 may be used with any of the fiber positioners 1002.

[0062] The solid portion of the shroud 1302 may be crimped or potted onto the optical fiber 802, so that the optical fiber 802 extends to a point just inside the portion of the shroud 1302 where the skirt begins. This may allow the nitinol structure ("arms") and the skirt to fold around and beyond the tip of the optical fiber 802. Although the shroud 1302 is presented as a 180-degree structure, it is understood that the shroud 1302 may present any amount of circumferential covering between 0 degrees (no covering) and 360 degrees (full circumferential covering).

[0063] Figures 14A and 14B illustrate perspective views of a single optical fiber 802 moving along an elongated body 302, and an elongated cavitation bubble 1404 generated at the distal fiber end 1402. Specifically, Figure 14A illustrates the distal elongated body portion 306, while Figure 14B illustrates a magnified view of the distal fiber end 1402 of the optical fiber.

[0064] Elongated cavitation bubbles 1404 are shown in Figures 14A and 14B, but in some embodiments, smaller cavitation bubbles 1404 may be generated. In any case, a single optical fiber 802 may travel the length of the elongated body 302 and terminate near the distal elongated body portion 306. In embodiments including an IVL balloon 204, the optical fiber 802 may terminate within the IVL balloon 204. When small cavitation bubbles 1404 are used, the distal fiber end 1402 may be located at least partially concentric with the treatment site. Here, the cavitation bubble 1404 is formed through energy generation and subsequent direction of energy along the optical fiber. This energy dissipates from the distal fiber end 1402 and then interacts with the saline / contrast fluid mixture to generate the cavitation bubble. When these cavitation bubbles 1404 burst, the shock wave is propelled radially away from the point of rupture, impacting or penetrating the treatment site and damaging any existing calcification.

[0065] In the case of elongated cavitation bubbles as shown in Figures 14A and 14B, the process is very similar. However, the difference lies in the pulse width and frequency generated to produce the Moses effect. The Moses effect is the propagation of the cavitation bubble. The forming cavitation bubble 1404 allows subsequent laser energy to travel through the forming cavitation bubble and deposit the laser energy at the most distal end of the cavitation bubble 1404, i.e., the end of the cavitation bubble 1404 furthest from the distal fiber end 1402. The cavitation bubble 1404 continues to propagate and rupture through the length of the treatment site (the area of ​​the saline / contrast fluid mixture, e.g., the vascular portion replaced by blood or the area up to the length of the IVL balloon 204), enabling treatment of lesions longer than a single cavitation bubble.

[0066] Targets 902, as described in Figures 9B, 10B, 10C, and 10D, are unlikely to be used in conjunction with the elongated body 302 that implements the Moses effect, as they significantly limit the distance that cavitation bubbles 1404 can propagate. In some embodiments, longer wavelength energy sources such as Ho:YAG or CTH:YAG may be utilized.

[0067] Figure 15 illustrates the cross-sectional views of the elongated body 302 and optical fiber 802 shown in Figures 14A and 14B. As can be seen in Figure 15, the optical fiber 802 includes a core 1502 and a cladding 1504. The cladding 1504 prevents laser energy from leaving the core 1502 and exiting the optical fiber 802. Not shown in Figure 15, but shown and described in Figures 16A to 18C, are notches in the cladding 1504 to allow laser energy to exit the optical fiber 802 to the distal fiber end 1402, and in some embodiments, such as the embodiments in Figures 14A, 14B, and 15, the system may prevent this laser energy from exiting the optical fiber 802 prematurely. Not shown, but according to some embodiments, the core may also have very small notches. As with Figures 7A and 7B, the radii and proportions of each feature are exaggerated to simplify the representation of each independent structure in the drawings.

[0068] Figures 16A and 16B show perspective views of a single optical fiber 802 moving along an elongated body 302 having notches 1602 cut into the optical fiber. Specifically, Figure 16A illustrates the distal elongated body portion 306, while Figure 16B illustrates magnified views of two of the notches 1602 in the optical fiber 802. Both Figures 16A and 16B show cavitation bubbles 1404 beginning at the notches 1602 in the optical fiber 802.

[0069] As shown in Figures 16A and 16B, each notch 1602 presents an energy exit point. This allows a single optical fiber 802 to be transformed into a multi-emitter laser fiber. In these embodiments, the energy is reflected within the optical fiber 802 until it finds a natural termination point through which it can emit energy, such as each of the notches 1602. As shown in Figure 16B, in addition to the notches 1602, energy can also be released through the opening at the distal fiber end 1402.

[0070] Similar to the single optical fiber 802 embodiment in Figures 14A and 14B, when energy is released from the incision, it reacts with the saline / contrast fluid mixture to generate cavitation bubbles. These cavitation bubbles 1404 then rupture, generating shock waves that collide with or penetrate the treatment area, damaging any existing calcifications. Similar to the Moses effect described above, the presence of multiple incisions 1602 allows for multiple cavitation bubbles 1404 throughout the treatment area, thus extending the length of applicable treatment.

[0071] As shown in Figure 16B, the distal fiber end 1402 can be used as an exit point, similar to the embodiments shown in Figures 14A and 14B. This distal fiber end 1402 can function similarly to the distal fiber end 1402 of a single optical fiber 802, in that cavitation bubbles 1404 can be formed there. Depending on the generator settings, such as pulse width and frequency, the Moses effect can be utilized at this distal fiber end 1402.

[0072] Figure 16A shows five notches 1602, and Figure 16B shows the two most distal notches 1602. There may be just one notch, or multiple notches 1602 (for example, in embodiments including an IVL balloon 204, the same number of notches 1602 that can fit within the IVL balloon 204).

[0073] Figure 17 illustrates the cross-sectional views of the elongated body and optical fiber shown in Figures 16A and 16B. Similar to Figure 15, the optical fiber 802 includes a core 1502 and a cladding 1504. The cladding prevents laser energy from leaving the core 1502 and exiting the optical fiber 802 at undesirable locations. Unlike in Figure 15, the cladding 1504 is depicted in Figure 17 as including a notch 1602. As shown and explained in Figures 16A and 16B, and later described in Figures 18A, 18B, and 18C, the notch 1602 allows laser energy to exit the optical fiber 802 before the distal fiber end 1402. This early exit allows for the formation of multiple cavitation bubbles 1404 along the body of the optical fiber 802, which can increase the effective length of treatment along the calcified lesion 50 within the treatment area 40. Similar to Figures 7A, 7B, and 15, the radii and proportions of each feature are exaggerated to simplify the representation of each independent structure in the drawings.

[0074] Figures 18A, 18B, and 18C illustrate various perspective views of multiple embodiments of optical fibers 802 with an elongated body 302. In each of Figures 18A to 18C, the termination point at the distal fiber end 1402 of each optical fiber 802 depicts the initiation of cavitation bubbles.

[0075] According to the elongated body 302 in Figures 18A-18C, each optical fiber 802 operates similarly to the elongated body 302 in Figures 14A and 14B. Energy is transmitted from the generator 310 through each optical fiber. As the energy is released from each distal fiber end 1402a, 1402b, 1402c, and 1402d, it interacts with the saline / contrast fluid mixture, as shown, and can create cavitation bubbles 1404. When the cavitation bubbles 1404 burst, shock waves are propelled substantially radially away from each point of rupture, impacting and penetrating the treatment site and damaging any existing calcifications. Because there are multiple optical fibers 802 and the distal fiber ends 1402 are positioned at a distance from each other longitudinally, multiple cavitation bubbles 1404 can be formed along the length of the treatment area, thus increasing the size of the treatable lesion.

[0076] By controlling the pulse width and frequency of the delivered energy, the operator can also achieve the Moses effect from each optical fiber 802. However, the advantage of achieving this with multiple laser emitters 206 may be less effective than with a single laser emitter, since multiple laser emitters 206 already achieve the goal of lengthening the treatment area.

[0077] Depending on the energy source used, the target 902 or multiple targets 902 may also be fitted with a distal elongated body portion 306 to absorb the energy provided by the optical fiber 802. Similar to the exemplary targets 902 in Figures 9B, 10B, 10C, and 10D, the target 902 may be heated as a result of absorbing this energy. As the target 902 continues to heat, cavitation bubbles 1404 may form on the target 902 as a result of the target heating the surrounding saline / contrast solution. In this case, the wavelength of the energy may not be intended to be directly absorbed by the saline / contrast fluid mixture. All of the energy is delivered to the target 902 and may promote the generation of superheated cavitation bubbles 1404 on the surface of the target 902 through the absorption of this generated heat by the saline / contrast fluid mixture.

[0078] Although not shown in Figures 18A to 18C, the optical fiber 802 can be locked in place by the fiber positioner 1002. The fiber positioner 1002 ensures that the relationship between each distal fiber end 1402 and its associated target 902 remains consistent, and that the distance at which each optical fiber 802 is offset from the central lumen 208 remains consistent.

[0079] Each of Figures 18A to 18C shows five optical fibers 802. There may be only one optical fiber 802 (as shown in Figures 14A and 14B), or a number of optical fibers 802 that can fit inside the IVL balloon 204 (in embodiments including the IVL balloon 204), or the maximum number of optical fibers 802 that can fit inside the vascular system being treated.

[0080] The exemplary elongated bodies 302 in Figures 18A-18C represent optical fibers 802 surrounding a central lumen 208, with distal fiber ends 1402 terminating at different points along the central lumen 208. For example, the optical fibers 802 may be further spaced apart from each other, or they may be provided to be arranged symmetrically around the central lumen 208. Any configuration may be utilized.

[0081] Although cross-sectional views are not illustrated in Figures 18A to 18C, it is understood that the cross-section may look similar to the uncut cross-section in Figure 15 or the cross-section with the notch 1602 in Figure 17. In either case, the only difference is the number of optical fibers 802 surrounding the elongated body 302.

[0082] In all of Figures 14A to 18C, it is understood that the cavitation bubbles 1404 formed by any means disclosed herein are thought to radiate outward from the essentially central part of the elongated body 302, despite the short radius in which each optical fiber 802 exists. The central lumen 208 does not interfere with the cavitation bubbles 1404 in any meaningful way. Therefore, it is understood that each cavitation bubble 1404 provided radiates completely or nearly completely around the vessel wall in a 360-degree range. In embodiments in which the central lumen 208 generates some shading, the cavitation bubbles 1404 still radiate in a 360-degree range around the vessel wall, although some variability in the magnitude of bubble intensity around this periphery may be observed.

[0083] Figures 19A to 19H illustrate side views of various distal fiber ends 1402 of an optical fiber 802, which may be provided within an elongated body 302. In embodiments of distal fiber ends 1402 intended for collecting light or optical signals (e.g., Figures 19A, 19C, 19D, 19E, and 19H), the shape of the fiber tip in the distal fiber end 1402 can improve the capability of the aforementioned fiber querying mechanism 524. By increasing the probability that light or optical signals reflected back from the optical fiber 802 are captured by the distal fiber end 1402 through the use of these various fiber tips, it becomes less likely that false negatives of fiber-related problems such as breakage will be reported. Therefore, clinicians will not prematurely remove the elongated body 302 due to poor data reporting fiber-related problems.

[0084] In embodiments of the distal fiber end 1402 intended for emission of light or laser energy in a specific direction (Figures 19B, 19C, 19D, 19F, and 19G), the shape of the fiber tip in the distal fiber end 1402 can influence the amount of energy delivered to a point by facilitating directional emission of the laser, redirection of the laser without bending the optical fiber, or narrowing or widening of the light beam or optical signal.

[0085] Furthermore, the embodiments illustrated in Figures 19C and 19D can facilitate the collection of light or optical signals from a laser, as well as the emission of light or optical signals from a laser. The fiber tip includes functionality to improve both of these operations and, therefore, can assist both as a means of delivering the laser and as a safety measure in the form of sensing the reflected laser, depending on the user's needs.

[0086] Figure 19A shows a distal fiber end 1402 with a frustocone 1902 (increased radial dimension) in several embodiments. The frustocone 1902 can increase the laser spot size and decrease the power density at the interface between the distal fiber end 1402 and the saline / contrast fluid mixture or target 902. Figure 19B illustrates a distal fiber end 1402 with a taper 1904 (decreased radial dimension). The tapered 1904 profile can decrease the laser spot size and increase the laser fluence or energy density.

[0087] Figure 19C shows an optical fiber 802 having a distal fiber end 1402 including a convex lens 1906. The convex lens 1906 can increase the collection of light or optical signal from the laser while reducing divergence. Figure 19D illustrates a distal fiber end 1402 including a concave lens 1908 in some embodiments. The concave lens 1908 can increase the divergence of light or optical signal from the laser.

[0088] Figure 19E illustrates an optical fiber 802 having a distal fiber end 1402 including a spherical ball lens 1910. The spherical ball lens 1910 can increase the angle of potential light collection by the optical fiber. Figure 19F shows the distal fiber end 1402 including a diffuser tip 1912. The diffuser tip 1912 can enable full peripheral illumination through all sides of the distal fiber end 1402.

[0089] Figure 19G shows an optical fiber 802 with a distal fiber end 1402 that includes a lateral emission tip 1914. The angle of the lateral emission tip 1914 redirects the laser at least partially with respect to the transverse angle of the elongated body 302 passing through the vascular system. This redirection can be any angle, including substantially perpendicular angles, as well as a 180-degree redirection of the laser. Figure 19H illustrates a distal fiber end 1402 that includes an angled end 1916. The angled end 1916 can reduce back reflection when collecting light or laser energy.

[0090] In all of Figures 19A to 19H, when the IVL balloon 204 is located on the elongated body 302, the polished distal fiber end 1402 terminates within the IVL balloon 204. The polished distal fiber end 1402 may be cleaved, shaped, or flame polished. In all embodiments including the balloon 204, the rough edges of the distal fiber end 1402 may be undesirable as they can generate abrasion and cracking on the inner wall of the balloon 204, potentially reducing the average lifespan of the balloon 204. However, it is understood that polishing the distal fiber end 1402 is never necessary without affecting the overall capabilities of the IVL system 10.

[0091] Any suitable energy source for providing energy through the optical fiber 802 to generate cavitation bubbles through interaction with either the saline / contrast fluid mixture or the target 902 may be used in conjunction with any of the exemplary IVL systems 10 and features depicted in Figures 1 to 19H. Some embodiments involve the use of laser media such as Nd:YAG (neodymium-doped:yttrium aluminum garnet), Ho:YAG (holmium), or CTH:YAG (chromium, thulium, holmium). Laser oscillating media such as Nd:YAG with a short wavelength (about 3124 nanometers in the case of Nd:YAG) may offer advantages over the use of the target 902 described in Figures 9B, 10B, 10C, and 10D. Laser-emitting media with longer wavelengths (approximately 2.1 microns for CTH:YAG, for example) such as CTH:YAG may benefit from the IVL system 10, and cavitation bubbles 1404 are formed through interaction with the saline / contrast fluid mixture. In addition, different types of excitation lasers, such as discharge-excited excimer lasers or flashlamp-excited lasers, may be used in any of the exemplary IVL systems 10 and features depicted in Figures 1 to 19H.

[0092] The dimensions of the lasers offered include wavelengths in the range of 308 nanometers to 2.1 microns (examples include a 308 nanometer excimer laser and a 355 nanometer 3x Nd:YAG laser), but any suitable wavelength may be used. The pulse width may be "long" (about 300 to 600 microseconds) or short (less than 100 nanoseconds). The pulse repetition rate may be about 1 to 2 hertz (Hz), and any pulse repetition rate may be used. The diameter of the optical fiber 802 includes 150 micrometers, 175 micrometers, and 200 micrometers. In this case as well, any diameter of functional optical fiber 802 may be used. The energy levels offered may be 40 to 1500 millijoules (mJ) and similar.

[0093] Figure 20 illustrates a flowchart illustrating a method for generating cavitation bubbles within a balloon catheter. In some embodiments, the method includes providing a medical device in accordance with the description and drawings herein (step 2000). The medical device may be one of the medical devices illustrated and described in Figures 1 to 19H, or any combination of these embodiments. According to some embodiments, the method includes deploying a balloon within the patient's vascular system adjacent to a calcified lesion (step 2002). The balloon may surround or partially surround the distal end of the catheter.

[0094] The method may include inflating a balloon using a fluid (step 2004). This inflation may serve multiple purposes. For example, inflating the balloon with a fluid may bring the balloon into contact with a calcified lesion in the treatment area. In addition, the fluid used to inflate the balloon may act as a receptacle for energy incident from a laser source, if a laser source is provided. In this case, the fluid may be a saline / contrast fluid mixture of any proportions. In some embodiments, the method includes transmitting laser energy through an optical fiber (in step 2006). This laser energy is delivered through a catheter toward the distal end of the catheter. The laser energy is intended to heat a target, which is either a physical target (as described in step 2008b) or the fluid in the balloon (as described in step 2008a).

[0095] According to several embodiments, the method includes heating a fluid (in step 2008a). Laser energy is absorbed by a fluid such as a saline / contrast fluid mixture, and the absorbed energy subsequently heats the fluid. The method may include generating cavitation bubbles (in step 2010). As a result of the fluid becoming hot, cavitation bubbles are formed and can then be ruptured. These cavitation bubbles can generate high-energy pressure waves, which can be used to break up calcified lesions within the treatment area.

[0096] Alternatively, in some embodiments, the method includes heating a target (in step 2008b). This physical target may act as a receptacle for laser energy in this case. When the target is heated, its heat may be transferred to the surrounding fluid, and thus the surrounding fluid is also heated. According to some embodiments, the method includes generating cavitation bubbles (in step 2010). As described above, cavitation bubbles may be formed as a result of the fluid becoming hot, and then burst. Again, these cavitation bubbles may then generate high-energy pressure waves, which can be used to break up calcified lesions in the treatment area.

[0097] Figure 21 illustrates a flowchart illustrating a method for generating cavitation bubbles in a blood vessel. In some embodiments, the method includes (in step 2100) providing a medical device in accordance with the description and drawings herein. In this case as well, the medical device may be the medical devices shown and described in Figures 1 to 19H, or any combination of these embodiments. According to some embodiments, the method includes (in step 2102) transmitting a fluid through a central lumen. The provided fluid may be used to inflate a balloon, if one is present, as described in Figure 20. The provided fluid may also be used as a receptacle for energy incident from a laser source, if one is provided. In this case, the fluid may be a saline / contrast fluid mixture of any proportions.

[0098] The method may include (in step 2104) releasing fluid into the treatment area through the distal elongated body portion of the central lumen. In this case, there is no balloon; instead, the fluid is injected directly into the patient's vascular system. In some embodiments, the method includes (in step 2106) replacing blood in the treatment area. This blood replacement may facilitate better contact between the fluid and the walls of the treatment area, allowing pressure waves released from the disrupted cavitation bubbles to better fragment any existing calcified lesions. By removing blood from the treatment area, the fluid may fill all or substantial portions of the treatment area.

[0099] According to some embodiments, the method includes transmitting laser energy through an optical fiber (in step 2108). This laser energy can be delivered through a catheter toward the distal end of the aforementioned catheter. In some embodiments, the laser energy is intended to heat a target, which is a physical target (as described in step 2108b) or a fluid in a balloon (as described in step 2108a).

[0100] The method may include heating the fluid (in step 2110a). Laser energy may be absorbed by a fluid such as a saline / contrast fluid mixture, and the absorbed energy subsequently heats the fluid. In some embodiments, the method includes generating cavitation bubbles (in step 2112). As a result of the fluid becoming hot, cavitation bubbles may be formed and then burst. These cavitation bubbles may generate high-energy pressure waves, which can be used to break up calcified lesions within the treatment area.

[0101] Alternatively, according to some embodiments, the method includes heating a target (in step 2110b). This physical target may act as a receptacle for laser energy in this case. As the target is heated, its heat may be transferred to the surrounding fluid, and thus the surrounding fluid is also heated. The method may include generating cavitation bubbles (in step 2112). As described above, cavitation bubbles may be formed as a result of the fluid becoming hot, and then burst. Again, these cavitation bubbles may then generate high-energy pressure waves, which can be used to break up calcified lesions within the treatment area.

[0102] The disclosure includes a medical device 12 comprising an elongated body 302 having a distal elongated body portion 306 and a central longitudinal axis 308. According to some embodiments, the medical device 12 includes a balloon 204 positioned along the distal elongated body portion 306, the balloon 12 having an internal balloon surface 702 and an external balloon surface 704, and configured to receive a fluid 212 to inflate the balloon 204 so that the external balloon surface 704 contacts a calcified lesion 50 in the vascular system of a patient 20. The medical device 12 may include one or more pressure wave emitters 206 positioned along the central longitudinal axis 308 of the elongated body 302 within the balloon 204, the one or more pressure wave emitters 206 configured to propagate at least one pressure wave through the fluid 212 to fragment the calcified lesion 50. In some embodiments, at least one of the pressure wave emitters 206 includes an optical fiber 802 configured to transmit laser energy into the balloon 204. According to some embodiments, the laser energy is configured to generate cavitation bubbles 1404 within the fluid 212 upon contact with the fluid 212, thereby generating at least one pressure wave.

[0103] The optical fiber 802 may be terminated near the distal elongated body portion 306. In some embodiments, the medical device 12 further includes a laser energy generator 310, which is configured to selectively pulse laser energy. According to some embodiments, the pulsed laser energy is configured to generate a Moses effect.

[0104] The medical device 12 may further include a plurality of optical fibers 802, each optical fiber 802 configured to transmit laser energy and terminated at a distal fiber end 1402 at different distances along a distal elongated body portion 306. In some embodiments, the laser energy is emitted from the distal fiber end 1402.

[0105] According to some embodiments, the optical fiber 802 includes a core and a cladding. In some embodiments, the cladding is arranged around the core, and laser energy is emitted from the core through notches located within the cladding. The medical device 12 may further include a plurality of optical fibers 802 arranged around a distal elongated body portion 306.

[0106] In some embodiments, the laser energy is configured to have a wavelength of approximately 1900 nanometers (nm) to 2100 nm. According to some embodiments, the wavelength is approximately 2000 nm. The isotopes of the doping element may cause some small broadening of the wavelength, and the doping concentration in the crystal may similarly shift the wavelength slightly. For this reason, "approximately" as used herein in conjunction with "wavelength" is intended to mean plus or minus 30 nm. In some embodiments, the wavelength is 1970 nm to 2030 nm. In embodiments using a CTH:YAG laser, the wavelength may be selected from the group consisting of 1970 nm, 2030 nm, 2080 nm, 2091 nm, 2097 nm, and 2121 nm. In embodiments using a Ho:YAG laser, the wavelength may be approximately 2100 nm.

[0107] In some embodiments, the laser energy is configured to have an energy of approximately 40 mJ to approximately 1500 mJ. According to some embodiments, the laser energy has a pulse width of approximately 10 nanoseconds to approximately 600 microseconds. The laser energy may have a pulse repetition rate of approximately 1 Hz to approximately 2 Hz.

[0108] In some embodiments, the medical device 12 further includes an Nd-YAG laser configured to provide laser energy. According to some embodiments, the medical device 12 further includes a holmium laser selected from the group consisting of Ho:YAG and CTH:YAG, the holmium laser configured to provide laser energy. The medical device 12 may further include an excimer laser configured to provide laser energy.

[0109] In some embodiments, the medical device 12 further includes a pressure sensor 522 configured to detect the rupture of the balloon 204, the pressure sensor 522 being configured to stop the laser energy when it detects the rupture of the balloon. This detection may also occur due to any loss of pressure above a certain threshold. According to some embodiments, the medical device 12 further includes a fiber query mechanism 524 configured to detect damage to the optical fiber 802.

[0110] The medical device 12 may further include a target 902 disposed distal to the optical fiber 802. In some embodiments, at least one of the pressure wave emitters 206 includes an optical fiber 802 configured to transmit laser energy into a balloon 204 and collide with the target 902. According to some embodiments, the target 902 is configured to heat up when collided with by the laser energy, and the heat from the target 902 is configured to heat the fluid 212, causing the emission of a pressure wave. The medical device 12 may further include an optical fiber 802 having a distal fiber end 1402 and a fiber positioner 1002 that maintains a constant distance between the distal fiber end 1402 and the target 902, thereby ensuring that the laser energy transmitted to the balloon 204 collide with the target 902.

[0111] In some embodiments, the medical device 12 defines a central lumen 208 extending through an elongated body 302, the central lumen 208 having a proximal luminal end and a distal luminal end opposite the proximal luminal end. In some embodiments, the central lumen 208 is configured to carry a fluid 212 to replace blood in a treatment area 40 adjacent to a calcified lesion 50 in the vascular system of a patient 20.

[0112] According to some embodiments, a balloon surface selected from the group consisting of an internal balloon surface 702, an external balloon surface 704, and combinations thereof, further includes a metallized coating 706 configured to increase the damage threshold of the balloon 204.

[0113] Figure 22 illustrates another side view of an exemplary IVL system including a medical device 12. As shown, the medical device 12 extends from a proximal end 2204 to a distal end 2206. An elongated body 302, such as a catheter, is mounted within the medical device 12 and may extend along the length of the medical device 12. A portion of the elongated body 302 near the distal end 2206 is referred here to as the distal elongated body portion 2202. The distal elongated body portion 2202 may extend all the way from where the elongated body 302 enters the balloon 204 to the distal end 2206, as seen in Figure 22. In some embodiments, the distal elongated body portion 2202 may extend proximal to the balloon 204 or terminate at the same point where the balloon 204 comes into contact with the elongated body 302 at its distal end.

[0114] In either case, the distal elongated body portion 2202 may have a different cross-sectional size from the rest of the elongated body 302. This may offer advantages such as reducing the cross-profile of the medical device 12 due to components added along this distal elongated body portion 2202, such as a balloon 204 or a fiber positioner, as illustrated and described in this disclosure and further illustrated and described. In addition, the distal elongated body portion 2202 may have a different cross-sectional shape from the rest of the elongated body 302.

[0115] One of the problems seen in the prior art is how to manipulate and move the optical fiber longitudinally. It is desirable to move the optical fiber relative to the catheter, as it becomes more difficult to move the entire device once the balloon is filled. In particular, if the balloon is intended to come into contact with a blood vessel, or in this case, a calcified lesion within a blood vessel, it may be necessary to deflate or partially deflate the balloon to reposition the entire device. Therefore, this problem can be improved by moving the optical fiber within the balloon. Although devices capable of moving the optical fiber longitudinally are known, one of the problems that remains unresolved in the prior art is how to achieve this longitudinal movement, and this disclosure seeks to solve this problem.

[0116] Figures 23A, 23B, and 23C illustrate diagrams of IVL devices including a movable fiber positioner according to several embodiments. Specifically, Figure 23A shows an IVL device including a spring 2308a attached to the fiber positioner 2302 proximal to the fiber positioner 2302. This spring 2308a may be attached to a permanently or semi-permanently fixed component of the IVL device, such as a marker band 2306a or other components (as shown). The marker band 2306a may assist the operator in locating the IVL device within the patient's vascular system.

[0117] In this embodiment, the fiber positioner 2302 can be stationary at a nominal position relative to the IVL device. The operator can achieve longitudinal movement relative to the fiber positioner 2302 by either manipulating the fiber positioner 2302 itself or by manipulating an optical fiber 802 that is fixedly coupled to the fiber positioner 2302. When the fiber positioner 2302 is moved distally, the fiber positioner places the spring 2308a under tension, causing the spring 2308a to attempt to return to its nominal position. The operator can then lock the fiber positioner 2302 or the spring 2308a in place while performing the procedure. The operator can then unlock the fiber positioner 2302 or the spring 2308a once the procedure is complete, allowing the spring 2308a to return to its nominal position before retracting the IVL device.

[0118] Similarly, when the fiber positioner 2302 is moved proximal, the fiber positioner compresses the spring 2308a, causing the spring 2308a to attempt to return to its nominal position. Again, the operator may then lock the fiber positioner 2302 or the spring 2308a in place while performing the procedure. The operator may then again unlock the fiber positioner 2302 or the spring 2308a once the procedure is complete, allowing the spring 2308a to return to its nominal position before retracting the IVL device.

[0119] In some embodiments, the nominal position of the spring 2308a may be a fully compressed state. In such embodiments, the operator can only push the fiber positioner 2302 distally, and thus the spring 2308a is placed under tension.

[0120] Figure 23B illustrates a similar IVL device, but in this embodiment, the spring 2308b is distal to the fiber positioner 2302. Also in this embodiment, a fixed component, in this case the marker band 2306b, is distal to the fiber positioner 2302. Here again, the marker band 2306b can assist the operator in locating the IVL device within the patient's vascular system.

[0121] This means that when the fiber positioner 2302 is moved distally, the spring 2308b is placed under compression. Alternatively, when the fiber positioner 2302 is moved proximal, the spring 2308b is placed under tension. In both cases, the spring 2308b is expected to return to its nominal position, but the operator may lock the spring 2308b and / or the fiber positioner 2302 in place during the procedure.

[0122] As can be considered with reference to Figure 23A, the nominal position of spring 2308b may be in a fully compressed state. However, due to the different position of spring 2308b compared to spring 2308a, the operator can only pull the fiber positioner 2302 proximal, and therefore spring 2308b can be placed under tension.

[0123] In either case, whether the spring 2308 is compressed or under tension, when the operator releases the spring 2308 (or the component holding the spring 2308 in place), the compressive force or tension will be released, returning the spring 2308 to its nominal position. This can assist in returning the fiber positioner 2302 and the optical fiber 802 to this nominal position. In the case of spring 2308a, the tension is formed by moving the fiber positioner 2302 distally, and this tension can facilitate the return of the fiber positioner 2302 and the optical fiber 802 to their proximal nominal position. In the case of spring 2308b, the tension is formed by moving the fiber positioner 2302 proximal, and this tension can facilitate the distal return of the fiber positioner 2302 and the optical fiber 802 to their nominal position.

[0124] Figure 23C combines the features of Figures 23A and 23B. In this embodiment, both the proximal spring 2308a and the distal spring 2308b are coupled to the fiber positioner 2302. Again, the permanent or semi-permanent fixture to which these springs 2308 are coupled is the marker band 2306, in this case the proximal marker band 2306a and the distal marker band 2306b.

[0125] In this embodiment, by moving the fiber positioner 2302 proximal, spring 2308a is placed under compression and spring 2308b is placed under tension. This can cause greater resistance, and springs 2308 will attempt to return to their nominal positions. Alternatively, by moving the fiber positioner distal, spring 2308a is placed under tension and spring 2308b is placed under compression.

[0126] In other embodiments, due to this additional resistance, springs with lower spring constants may be used. Since springs with lower spring constants can be smaller, this may facilitate the creation of a smaller crossover profile for the IVL device.

[0127] In the embodiment shown in Figure 23C, the nominal position of the fiber positioner 2302 can be seen when either spring 2308a is fully compressed or spring 2308b is fully compressed, but not both. If the nominal position of the fiber positioner 2302 has both spring 2308a and spring 2308b under full compression, the fiber positioner is likely unable to move longitudinally.

[0128] Figure 24 illustrates a cross-sectional view of the IVL device shown in Figure 23A. In this embodiment, the spring 2308a and marker band 2306a are located near the fiber positioner 2302 and are therefore not visible.

[0129] Figure 25 illustrates the cross-sectional view of the medical device shown in Figures 23B and 23C. In this embodiment, the spring 2308b and marker band 2306b are located distal to the fiber positioner 2302 and are therefore not visible.

[0130] Another problem seen in prior art solutions for longitudinal movement of optical fibers is that the optical fiber may attempt to move rotationally relative to the guidewire lumen (or central axis, or the entire IVL device, etc.). Particularly in cases where the optical fiber itself is manipulated by an operator, the optical fiber may attempt to "kick," which is to move not only longitudinally but also at an angle. This is problematic because the more radially offline the optical fiber is, i.e., rotationally offset from its nominal position relative to the central axis, the greater the longitudinal translational resistance of the optical fiber, which can make it more difficult for the operator to displace the optical fiber longitudinally. Allowing the optical fiber to move rotationally can also increase wear and breakage of the optical fiber, potentially leading to problems with the durability of the optical fiber.

[0131] This disclosure also seeks to improve upon this drawback in prior art solutions. Through the following disclosure, a fiber positioner can be rotationally fixed to a catheter. The provided optical fiber extends through the fiber positioner or is otherwise coupled to the fiber positioner, thus preventing the optical fiber from rotating relative to the catheter. Therefore, by knowing the position of the catheter through means such as a provided marker band, the operator can know the precise position of the optical fiber longitudinally and axially in order to deliver the most effective treatment.

[0132] Figure 26 illustrates an IVL device in which the distal fiber end of optical fiber 802 is held in place. The purpose of Figure 26 is to direct the viewer to the location of the cross-sectional view of the fiber positioner 2602, as seen in Figures 27A, 27B, 27C, 27D, and 27E. However, it will be understood that perspective views of the fiber positioner 2602, such as the fiber positioner shown in Figures 11A, 11B, 11C, and 11D, may also be used in conjunction with this disclosure.

[0133] Figures 27A, 27B, 27C, 27D, and 27E illustrate various embodiments of the cross-section of the IVL device of Figure 26. Specifically, Figure 27A illustrates a circular fiber positioner 2602a including a circular distal elongated body portion 2604a. In this embodiment, the fiber positioner 2602a includes a projection 2702a for receiving the optical fiber 802. Both this exemplary fiber positioner 2602a and the distal elongated body portion 2604a are shown to have zero eccentricity, which may allow the aforementioned rotation of the optical fiber 802.

[0134] Figure 27B illustrates an elliptical fiber positioner 2602b surrounding an elliptical distal elongated body portion 2604b. The specific shapes of the ellipses in both the fiber positioner 2602b and the distal elongated body portion 2604b are not important, as long as their respective eccentricities are greater than zero and less than 1. This is because, when the eccentricity is greater than zero and less than 1, the fiber positioner 2602b cannot rotate around the distal elongated body portion 2604b, and thus the axial position of the optical fiber 802 relative to the distal elongated body portion 2604b is maintained. Figure 27B also shows a projection 2702b for receiving the optical fiber 802 within the fiber positioner 2602b.

[0135] Figure 27C illustrates a distal elongated body portion 2604c including a longitudinal groove 2706. In this embodiment, the fiber positioner 2602c includes an indentation 2708 configured to be received by the longitudinal groove 2706. In this way, the fiber positioner 2602c is prevented from rotating around the distal elongated body portion 2604c, and thus the axial position of the optical fiber 802 relative to the distal elongated body portion 2604c is maintained. In addition, the longitudinal groove 2706 may extend along the entire length of the distal elongated body portion 2604c or may extend only over a portion of the distal elongated body portion 2604c. In embodiments where the longitudinal recess 2706 does not extend along the entire length of the distal elongated body portion, the longitudinal recess 2706 can prevent the fiber positioner 2602c from moving further longitudinally than the length of the longitudinal recess 2706.

[0136] Figure 27C shows a projection 2702c for receiving the optical fiber 802 within the fiber positioner 2602c. In all of Figures 27A, 27B, and 27C, it is understood that these projections 2702 are merely embodiments, and other solutions for maintaining the optical fiber 802 within the fiber positioner 2602 are equally functional.

[0137] For example, Figure 27D illustrates another distal elongated body portion 2604d, which includes a longitudinal indentation 2706, along with another fiber positioner 2602d, which includes an indentation 2708 configured to be received by a longitudinal indentation 2706. However, in this case, the optical fiber 802 may be nested within the indentation 2708 of the fiber positioner 2602d on the opposite side of the longitudinal indentation 2706 of the distal elongated body portion 2604d. Although the illustration in Figure 27D is simplified, it is understood that the indentation 2708 may further surround the optical fiber 802 to prevent it from separating from the fiber positioner 2602d. In this context, “separation” is intended to be interpreted as one object becoming unconnected to another object, either actively or passively.

[0138] Figure 27E illustrates a distal elongated body portion 2604e that includes a longitudinal recess 2706, but in this embodiment, the surrounding fiber positioner 2602e does not include indentation. Instead, the optical fiber 802 extends through the fiber positioner 2602e near the longitudinal recess 2706. In this embodiment, the longitudinal recess 2706 prevents the optical fiber 802 itself from rotating, so the fiber positioner 2602e is prevented from rotating around the distal elongated body portion 2604e. This is another way in which the axial position of the optical fiber 802 relative to the distal elongated body portion 2604e can be preserved.

[0139] Figures 28A and 28B illustrate diagrams of an IVL device including a fiber positioner lumen. In both Figures 28A and 28B, the fiber positioner 2802 is shown coupled to a distal elongated body portion 2808. However, in these embodiments, the fiber positioner 2802 does not surround the distal elongated body portion 2808. Instead, multiple lumens extend through the catheter, one being the guidewire lumen 2804 and the other the fiber positioner lumen 2806.

[0140] Specifically, in Figure 28A, the fiber positioner lumen 2806a terminates proximal to the distal end 2206. This termination point can prevent the fiber positioner 2802 from moving further distally. In Figure 28B, the fiber positioner lumen 2806b extends along the length of the distal elongated body portion 2808. In both the fiber positioner lumen 2806a and the fiber positioner lumen 2806b, a slit may be present to fluidly connect the inner portion of the fiber positioner lumen 2806 to the outside of the distal elongated body portion 2808. This is illustrated in Figure 29, a cross-sectional view of the IVL device in Figures 28A and 28B.

[0141] As seen in Figure 29, a slit 2902 is present, through which a portion of the fiber positioner 2802 may extend. The purpose of this is to ensure that the optical fiber 802 is outside the distal elongated body portion 2808, thereby preventing the emitted laser energy from being interfered with by the distal elongated body portion 2808. As can also be seen in Figure 29, a portion of the fiber positioner 2802 may be shaped to align at least partially with the fiber positioner lumen 2806. This is another configuration in which the fiber positioner 2802 can be rotationally fixed, if not completely, to the distal elongated body portion 2808, thereby maintaining the axial position of the optical fiber 802 relative to the distal elongated body portion 2808.

[0142] Furthermore, the slit 2902 may extend for a specific distance along the distal elongated body portion 2808. In this way, the proximal and distal endpoints of the slit 2902 can act as stopping points for the longitudinal movement of the fiber positioner 2802. That is, the proximal endpoint of the slit 2902 can prevent the fiber positioner 2802 from moving further proximal in the longitudinal direction, and the distal endpoint of the slit 2902 can prevent the fiber positioner 2802 from moving further distal in the longitudinal direction.

[0143] Figure 30 illustrates a diagram of an IVL device including track 3006. Track 3006 may share some similarities with the fiber positioner lumen 2806, but unlike the lumen, it does not extend proximally to return to the controller. Track 3006 includes proximal and distal endpoints and thus controls how far the fiber positioner 3002 can travel longitudinally in both the proximal and distal directions.

[0144] Figure 31 illustrates a cross-sectional view of the IVL device shown in Figure 30. From this viewpoint, one embodiment can be seen of how the fiber positioner 3002 is rotationally fixed to the distal elongated body portion 3008. The slit 3108, which extends either a portion of the length of the track 3006 or the entire length of the track 3006, allows the fiber positioner 3002 to extend from the inside of the track 3006 to the outside of the distal elongated body portion 3008.

[0145] In this embodiment, the fiber positioner 3002 includes an upper portion 3102, an intermediate portion 3104, and a bottom portion 3106. The upper portion 3102 can be seen as surrounding the optical fiber 802 and thus keeping the optical fiber 802 fixed to the fiber positioner 3002. The bottom portion 3106 can be seen as seated within the track. The intermediate portion 3104 is shown to have a width smaller than the widths of the upper portion 3102 and the bottom portion 3106, and this intermediate portion 3104 is positioned where the slit 3108 may be present. By having a width larger than the intermediate portion 3104, the bottom portion 3106 is prevented from sliding out of the track 3006, and the upper portion 3102 is prevented from sliding into the track 3006. The fiber positioner 3002 cannot rotate within the track 3006, and therefore the axial position of the optical fiber 802 relative to the distal elongated body portion 3008 is maintained.

[0146] In any or all of the foregoing disclosures relating to fiber positioners, it is understood that the optical fiber 802 may be fixedly coupled to the fiber positioner or slidably coupled to it.

[0147] Figure 32 illustrates a perspective view of an exemplary controller 3202, and Figure 33 illustrates a perspective view of another exemplary controller 3302. Specifically, Figure 32 shows a controller 3202 including a slider 3204. The slider 3204 may be coupled to a catheter, an elongated body 302, and / or an optical fiber 802. The slider 3204 may allow longitudinal translation of any or all of these elements. In some cases, the slider 3204 may be used to reposition the elongated body 302 when it is at or near the treatment site. In additional cases, the slider 3204 may be used to reposition the optical fiber 802 within the elongated body 302, thereby eliminating the need to frequently or never move the elongated body 302 during treatment.

[0148] Figure 33 specifically illustrates a controller 3302 including a rack 3306 and a pinion 3304. The rack 3306 and pinion 3304, in an additional manner, achieve longitudinal translation of the catheter, the elongated body 302, and / or the optical fiber 802. Instead of moving the slider 3204, the operator may rotate the pinion 3304 to produce longitudinal movement on the rack 3306. Any additional methods, not shown in Figure 32 or 33, for giving longitudinal movement to the catheter, the elongated body 302, and / or the optical fiber 802 are considered to be operable with the remainder of this disclosure.

[0149] Figures 34–38 illustrate bottom views of various exemplary controllers, including the ability to move the optical fiber 802. These controllers may feature a slider 3204 in Figure 32 and / or a rack 3306 and pinion 3304 in Figure 33 to give movement to the optical fiber 802. These are in a form that can be located outside the catheter, which is a solution to the prior art problems referred to with reference to Figures 23A, 23B, and 23C.

[0150] Specifically, Figure 34 shows a controller 3402 including an expansion joint 3404. The expansion joint 3404 may include an inner tube slidably coupled to an outer tube. Either or both of the outer and inner tubes may be stainless steel hypotubes. In such embodiments, the outer tube may be fixedly coupled to the controller 3402 or to the lumen of the optical fiber. The inner tube may be fixedly coupled to the optical fiber 802. In such embodiments, as the inner tube slides through the outer tube, this longitudinal movement is imparted to the optical fiber 802. The purpose of such an expansion joint 3404 is to allow the optical fiber 802 to be pushed longitudinally without causing it to buckle.

[0151] Figures 35, 36, and 37 illustrate possible embodiments of a controller that includes a mechanism for passively managing slack that may occur in an optical fiber as it moves longitudinally. Specifically, Figure 35 illustrates a controller 3502 including a pin 3504. As shown in Figure 35, the pin 3504 may be oriented longitudinally with respect to the controller 3502. In such embodiments, the optical fiber 802 is wrapped around the pin 3504 so that any slack in the optical fiber 802 is taken up by the pin 3504. Rotation of the pin 3504 can cause the optical fiber 802 to wrap around or unwound, thereby giving the optical fiber 802 longitudinal movement.

[0152] Figure 36 illustrates a controller 3602 including a spring 3604. According to such an embodiment, the spring 3604 can be extended or retracted through an actuator on the controller 3602 accessible to an operator. When the spring 3604 is extended or retracted, the optical fiber 802 can be moved accordingly, thus providing the optical fiber 802 with longitudinal movement. In some embodiments, the spring 3604 is directly coupled to the optical fiber 802. In other embodiments, an intermediate material, such as a movable pin, is coupled to the spring 3604. In such embodiments, the optical fiber 802 can be wrapped around the pin (multiple times or once) to convert the movement of the spring 3604 into the optical fiber 802.

[0153] Although only a single spring 3604 is illustrated in Figure 36, it is possible to use multiple springs, and these springs can be additionally isolated throughout the controller housing, thereby absorbing further slack from the optical fiber 802.

[0154] Additionally, while spring 3604 is specifically named, it is understood that equivalent mechanisms may be used to achieve the same result. These include, but are not limited to, conventional springs, braided shafts (either metal or polymer), elastic bands, nitinol bands, and nitinol stent-like structures.

[0155] Figure 37 illustrates a controller 3702 including pin 3704. Unlike pin 3504 in Figure 35, this pin 3704 may be positioned perpendicular to the controller 3702. The optical fiber 802 may be wrapped around this pin 3704 so that slack is introduced. As the optical fiber 802 is moved from proximal to distal, the slack is reduced until the optical fiber 802 is finally stopped moving by pin 3704.

[0156] Figure 38 illustrates a controller 3802 that includes another modification of the expansion tube, similar to that shown in Figure 34. In Figure 38, a small hypotube 3806 is slidably coupled to a large hypotube 3804. Additionally, a spring 3808 may be coupled to each of the small hypotube 3806 and the large hypotube 3804. This spring 3808 may assist in the longitudinal movement of the small hypotube 3806. In some embodiments, the spring 3808 returns the small hypotube 3806 to its initial position. According to some embodiments, an optical fiber 802 is coupled to the small hypotube 3806, thereby imparting the longitudinal movement of the small hypotube 3806 to the optical fiber 802.

[0157] Additionally, while spring 3808 is specifically named, it is understood that equivalent mechanisms may be used to achieve the same result. These include, but are not limited to, conventional springs, braided shafts (either metal or polymer), elastic bands, nitinol bands, and nitinol stent-like structures.

[0158] In any or all of the exemplary controllers shown in Figures 34 to 38, a locking mechanism may be included within or on the controller. For example, this may include a ball retaining pin or a notch in the housing, which will hold the optical fiber 802 in place after it has been moved longitudinally to a predetermined position until it is moved by an operator.

[0159] Additionally, in Figures 34–38, optical fiber 802 is designated and numbered in more than one location. This is to facilitate understanding that it is the same component, as it is shown separated by other features, and should not be interpreted as meaning that there must be more than one optical fiber 802 in this specification. However, this does not mean that more than one optical fiber 802 cannot exist if desired.

[0160] The disclosure includes a device comprising an elongated body having a proximal end and a distal end opposite the proximal end, the elongated body extending along a central longitudinal axis. In some embodiments, the device includes a distal elongated body portion extending distally from the elongated body along the central longitudinal axis, the distal elongated body portion being located adjacent to the distal end. According to some embodiments, the device includes an optical fiber spaced apart from the central longitudinal axis and extending from the proximal end to the distal elongated body portion, the optical fiber configured to transmit laser energy to a fluid and propagate pressure waves to cavitation bubbles. The device may include a fiber positioner that at least partially surrounds an optical fiber in the circumferential direction and surrounds a distal elongated body portion in the circumferential direction, wherein the fiber positioner is translationally coupled to the distal elongated body portion so that the fiber positioner can move between a first position and a second position located distal to the first position, and the fiber positioner is rotationally fixedly coupled to the distal elongated body portion so that the fiber positioner maintains a fixed angle with respect to the distal elongated body portion.

[0161] In some embodiments, the optical fiber is fixedly coupled to the fiber positioner such that both the optical fiber and the fiber positioner are translatedly coupled to a distal elongated body portion and then rotated and fixed in place. According to some embodiments, the distal elongated body portion has an elliptical cross-sectional profile.

[0162] The distal elongated body portion may include a longitudinal recess configured to rotatably fix and couple the fiber positioner to the distal elongated body portion. In some embodiments, the fiber positioner includes an indentation configured to correspond to the longitudinal recess, thereby the longitudinal recess receiving the indentation. The indentation may partially surround the optical fiber. In some embodiments, the longitudinal recess partially surrounds the optical fiber. According to some embodiments, the fiber positioner includes a projection that at least partially surrounds the optical fiber circumferentially.

[0163] The disclosure also includes a device comprising an elongated body having a proximal end and a distal end opposite the proximal end, the elongated body extending along a central longitudinal axis. In some embodiments, the device includes a distal elongated body portion extending distally from the elongated body along the central longitudinal axis, the distal elongated body portion being located adjacent to the distal end. According to some embodiments, the device includes an optical fiber spaced apart from the central longitudinal axis and extending from the proximal end to the distal elongated body portion, the optical fiber configured to transmit laser energy to a fluid and propagate pressure waves to cavitation bubbles. The device may include a fiber positioner that at least partially surrounds an optical fiber in the circumferential direction and partially surrounds a distal elongated body portion, the fiber positioner being translationally coupled to the distal elongated body portion so that the fiber positioner can move between a first position and a second position located distal to the first position, and the fiber positioner being rotationally fixedly coupled to the distal elongated body portion so that the fiber positioner maintains a fixed angle with respect to the distal elongated body portion.

[0164] In some embodiments, the distal elongated body portion includes a longitudinal track. According to some embodiments, the fiber positioner comprises an upper portion, a bottom portion opposite the upper portion, and an intermediate portion between them, the upper portion partially surrounding the optical fiber in a circumferential direction. The intermediate portion may define a width smaller than the width of each of the upper portion and the bottom portion. In some embodiments, the longitudinal track comprises a proximal track end and a distal track end opposite the proximal track end, the proximal and distal track ends each configured to stop the movement of the fiber positioner.

[0165] In some embodiments, the distal elongated body portion comprises a guidewire lumen and a fiber positioner lumen. The distal elongated body portion may include a slit configured to fluidly couple the fiber positioner lumen to the outer edge of the distal elongated body portion. In some embodiments, the fiber positioner includes a projection configured to extend from the fiber positioner lumen through the slit beyond the outer edge of the distal elongated body portion, the projection at least partially surrounding the optical fiber.

[0166] According to some embodiments, the fiber positioner lumen comprises a proximal fiber positioner lumen end starting from the proximal end and a distal fiber positioner lumen end opposite to the proximal fiber positioner lumen end, the distal fiber positioner lumen end being located proximal to the distal end of the elongated body, and the distal fiber positioner lumen end being configured to stop the movement of the fiber positioner.

[0167] The disclosure also includes a device comprising an elongated body having a proximal end and a distal end opposite the proximal end, the elongated body extending along a central longitudinal axis. In some embodiments, the device includes a distal elongated body portion extending distally from the elongated body along the central longitudinal axis, the distal elongated body portion being located adjacent to the distal end. According to some embodiments, the device includes a balloon positioned along the distal elongated body portion, the balloon having an internal balloon surface and an external balloon surface, the balloon being configured to receive an inflation fluid for inflating the balloon such that the external balloon surface contacts a calcified lesion in the patient's vascular system. The device may include an optical fiber spaced away from the central longitudinal axis and extending from the proximal end to the distal elongated body portion, the optical fiber being configured to transmit laser energy to the inflation fluid and propagate a pressure wave to the cavitation bubble. In some embodiments, the device includes a fiber positioner that at least partially surrounds an optical fiber in the circumferential direction, the fiber positioner being translationally coupled to a distal elongated body portion so that the fiber positioner can move between a first position and a second position located distal to the first position, and the fiber positioner being rotationally fixedly coupled to the distal elongated body portion so that the fiber positioner maintains a fixed angle with respect to the distal elongated body portion.

[0168] According to some embodiments, the fiber positioner comprises a distal surface and a proximal surface opposite to the distal surface, and the proximal and distal surfaces of the fiber positioner are located longitudinally within the balloon. The fiber positioner may include a distal surface and a proximal surface opposite to the distal surface, with the proximal surface of the fiber positioner being distal to the proximal end of the balloon and the distal surface of the fiber positioner being proximal to the distal end of the balloon.

[0169] None of the steps described herein are essential or indispensable. Any of the steps can be adjusted or modified. Other or additional steps can be used. Any part of the steps, processes, structures, and / or devices disclosed or illustrated in one embodiment, flowchart, or example herein can be combined with, together with, or substituted for, any other part of the steps, processes, structures, and / or devices disclosed or illustrated in a different embodiment, flowchart, or example herein. The embodiments and examples provided herein are distinct from and are not intended to be separate from one another.

[0170] The section headings and subheadings provided herein are not limiting. They do not represent or limit the entire scope of the embodiments described in the section to which they relate. For example, a section titled “Topic 1” may include embodiments not related to Topic 1, and embodiments described in other sections may apply to and be combined with embodiments described within the “Topic 1” section.

[0171] The various features and processes described above may be used independently of each other or combined in various ways. All possible combinations and partial combinations are intended to fall within the scope of this disclosure. In addition, certain methods, events, states, or process blocks may be omitted in some embodiments. The methods, steps, and processes described herein are also not limited to any particular order, and the blocks, steps, or states associated therewith may be performed in other appropriate orders. For example, the described tasks or events may be performed in an order other than the specifically disclosed order. Multiple steps may be combined into a single block or state. Exemplary tasks or events may be performed in series, in parallel, or in any other way. Tasks or events may be added to or removed from the disclosed exemplary embodiments. Exemplary systems and components described herein may be configured differently from those described. For example, elements may be added to, removed from, or reconfigured in comparison to the disclosed exemplary embodiments.

[0172] Conditional language used herein, in particular "can," "could," "might," "may," and "e.g.," is generally intended to convey that a particular embodiment includes certain features, elements, and / or steps, while other embodiments do not, unless otherwise specifically stated or understood in a different context. Therefore, such conditional language does not generally imply that features, elements, and / or steps are required in any way for one or more embodiments, or that one or more embodiments necessarily involve logic for determining, with or without input or prompting from the author, whether these features, elements, and / or steps are included or should be implemented in any particular embodiment. Terms such as "comprising," "including," and "having" are synonymous and used non-restrictively and comprehensively, without excluding additional elements, features, actions, or behaviors. Furthermore, the term "or" is used in its inclusive sense (rather than its exclusive sense), and therefore, for example, when used to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Connecting phrases such as "at least one of X, Y, and Z" are understood differently in contexts in which they are commonly used to convey that an item, term, etc., may be any of X, Y, or Z, unless otherwise specifically stated. Thus, such connecting phrases do not generally imply that a particular embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z, respectively.

[0173] The term "and / or" means that "and" applies to some embodiments and "or" applies to some embodiments. Thus, A, B, and / or C can be replaced by A, B, and C as stated in one sentence and by A, B, or C as stated in another sentence. A, B, and / or C means that some embodiments may include A and B, some embodiments may include A and C, some embodiments may include B and C, some embodiments may include A only, some embodiments may include B only, some embodiments may include C only, and some embodiments may include A, B, and C. The term "and / or" is used to avoid unnecessary redundancy.

Claims

1. An elongated body having a proximal end and a distal end opposite to the proximal end, wherein the elongated body extends along the central longitudinal axis, A distal elongated body portion extending distally from the elongated body along the central longitudinal axis, wherein the distal elongated body portion comprises a distal elongated body portion located adjacent to the distal end, An optical fiber spaced apart from the central longitudinal axis and extending from the proximal end to the distal elongated body portion, wherein the optical fiber is configured to transmit laser energy to a fluid and propagate pressure waves to cavitation bubbles, A fiber positioner that surrounds the optical fiber at least partially in a circumferential direction and surrounds the distal elongated body portion in a circumferential direction, wherein the fiber positioner is translationally coupled to the distal elongated body portion so that the fiber positioner can move between a first position and a second position located distal to the first position, and the fiber positioner is rotationally fixed and coupled to the distal elongated body portion so that the fiber positioner maintains a fixed angle with respect to the distal elongated body portion.

2. The device according to claim 1, wherein the optical fiber is fixedly coupled to the fiber positioner such that each of the optical fiber and the fiber positioner is translatedly coupled to the distal elongated body portion and rotationally fixed and coupled.

3. The device according to claim 1, wherein the distal elongated body portion has an elliptical cross-sectional profile.

4. The device according to claim 1, wherein the distal elongated body portion has a longitudinal recess configured to rotately fix and connect the fiber positioner to the distal elongated body portion.

5. The device according to claim 4, wherein the fiber positioner includes an indentation configured to correspond to the longitudinal recess, so that the longitudinal recess receives the indentation.

6. The device according to claim 5, wherein the indentation partially surrounds the optical fiber.

7. The device according to claim 4, wherein the longitudinal recess partially surrounds the optical fiber.

8. The device according to claim 1, wherein the fiber positioner comprises a projection that at least partially surrounds the optical fiber in the circumferential direction.

9. An elongated body having a proximal end and a distal end opposite to the proximal end, wherein the elongated body extends along the central longitudinal axis, A distal elongated body portion extending distally from the elongated body along the central longitudinal axis, wherein the distal elongated body portion comprises a distal elongated body portion located adjacent to the distal end, An optical fiber spaced apart from the central longitudinal axis and extending from the proximal end to the distal elongated body portion, wherein the optical fiber is configured to transmit laser energy to a fluid and propagate pressure waves to cavitation bubbles, A fiber positioner that at least partially surrounds the optical fiber in a circumferential direction and partially surrounds the distal elongated body portion, wherein the fiber positioner is translationally coupled to the distal elongated body portion so that the fiber positioner can move between a first position and a second position located distal to the first position, and the fiber positioner is rotationally fixed and coupled to the distal elongated body portion so that the fiber positioner maintains a fixed angle with respect to the distal elongated body portion.

10. The device according to claim 9, wherein the distal elongated body portion is provided with a longitudinal track.

11. The device according to claim 10, wherein the fiber positioner comprises an upper portion, a bottom portion opposite to the upper portion, and an intermediate portion between them, the upper portion partially surrounding the optical fiber in a circumferential direction.

12. The device according to claim 11, wherein the intermediate portion defines a width smaller than the width of the upper portion and the width of the bottom portion, respectively.

13. The device according to claim 10, wherein the longitudinal track comprises a proximal track end and a distal track end opposite to the proximal track end, and the proximal track end and the distal track end are configured to stop the movement of the fiber positioner, respectively.

14. The device according to claim 9, wherein the distal elongated body portion comprises a guidewire lumen and a fiber positioner lumen.

15. The device according to claim 14, wherein the distal elongated body portion includes a slit configured to fluidly couple the fiber positioner lumen to the outer edge of the distal elongated body portion.

16. The device according to claim 15, wherein the fiber positioner includes a projection configured to protrude from the lumen of the fiber positioner through the slit beyond the outer edge of the distal elongated body portion, and the projection at least partially surrounds the optical fiber.

17. The device according to claim 14, wherein the fiber positioner lumen comprises a proximal fiber positioner lumen end beginning from the proximal end and a distal fiber positioner lumen end opposite to the proximal fiber positioner lumen end, the distal fiber positioner lumen end is located proximal to the distal end of the elongated body, and the distal fiber positioner lumen end is configured to stop the movement of the fiber positioner.

18. An elongated body having a proximal end and a distal end opposite to the proximal end, wherein the elongated body extends along the central longitudinal axis, A distal elongated body portion extending distally from the elongated body along the central longitudinal axis, wherein the distal elongated body portion comprises a distal elongated body portion located adjacent to the distal end, A balloon positioned along the distal elongated body portion, wherein the balloon has an inner balloon surface and an outer balloon surface, and the balloon is configured to receive an inflation fluid for inflating the balloon such that the outer balloon surface contacts a calcified lesion in the patient's vascular system, An optical fiber spaced apart from the central longitudinal axis and extending from the proximal end to the distal elongated body portion, wherein the optical fiber is configured to transmit laser energy to the expanding fluid and propagate pressure waves to the cavitation bubbles, A device comprising: a fiber positioner that at least partially surrounds the optical fiber in the circumferential direction, wherein the fiber positioner is translationally coupled to a distal elongated body portion so that the fiber positioner can move between a first position and a second position located distal to the first position, and the fiber positioner is rotationally fixed and coupled to the distal elongated body portion so that the fiber positioner maintains a fixed angle with respect to the distal elongated body portion.

19. The device according to claim 18, wherein the fiber positioner comprises a distal surface and a proximal surface opposite to the distal surface, and the proximal surface and the distal surface of the fiber positioner are located longitudinally within the balloon.

20. The device according to claim 18, wherein the fiber positioner comprises a distal surface and a proximal surface opposite to the distal surface, the proximal surface of the fiber positioner is distal to the proximal end of the balloon, and the distal surface of the fiber positioner is proximal to the distal end of the balloon.

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