Intravascular lithotripsy

Abstract

A medical device may include an elongate body having a distal elongate body portion and a central longitudinal axis. The medical device may include a balloon positioned along the distal elongate body portion. The balloon may be configured to receive a fluid to inflate the balloon such that the outer balloon surface contacts a calcification lesion within the patient's vasculature. The medical device may include one or more pressure wave emitters positioned along a central longitudinal axis of the elongate body. The one or more pressure wave emitters may be configured to propagate at least one pressure wave through the fluid to crush the calcification lesion. The 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

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] The entire contents of the following application are incorporated herein by reference: U.S. Provisional Patent Application No. 63 / 347,981, filed on June 1, 2022 and entitled INTRAVASCRULAR LITHOTRIPSY.

[0003] The entire contents of the following application are incorporated herein by reference: U.S. Provisional Patent Application No. 63 / 381,487, filed on October 28, 2022 and entitled INTRAVASCRULAR LITHOTRIPSY.

[0004] The entire contents of the following application are incorporated herein by reference: U.S. Provisional Patent Application No. 63 / 482,547, filed on January 31, 2023 and entitled INTRAVASCRULAR LITHOTRIPSY. Technical Field

[0005] The present disclosure relates to the treatment of calcified plaque lesions in the vasculature of a patient. Background Art

[0006] In an intravascular lithotripsy (IVL) procedure, clinicians use a catheter configured to break up calcified plaque lesions within a patient's vasculature. Some such methods include the creation and rapid collapse of cavitation bubbles to generate shock waves that cause such calcification disruption. Summary of the invention

[0007] The present disclosure describes systems and techniques for generating and directing energy to produce cavitation bubbles that are used to fragment and / or disintegrate calcified lesions within the vasculature of a patient. For purposes of illustration, the techniques herein are primarily described with respect to laser-based systems and corresponding applications thereof (such as coronary vascular applications, etc.). However, it should be understood that it can be assumed that the techniques described herein are equally applicable to similar systems based on other forms of energy (such as electrical-based systems, etc.) and corresponding applications (such as peripheral therapy applications, etc.), unless otherwise expressly noted below.

[0008] In some examples, a medical device (e.g., see Figure 1 The medical device 12 shown in FIG. 1 includes an elongated body (see, for example, Figure 3 The elongated body 302 shown in FIG. 1 has a distal elongated body portion (e.g., see FIG. Figure 3 The distal elongated body portion 306 shown in FIG. Figure 3According to some examples, the medical device includes a balloon positioned along the distal elongated body portion (e.g., see balloon 204 shown in FIG. 2 ), the balloon having an inner balloon surface (e.g., see Fig. 7A The inner balloon surface 702 shown) and the outer balloon surface (e.g., see Figure 7B 2) and is configured to receive a fluid (e.g., see fluid 212 shown in FIG. 2) to inflate the balloon so that the outer balloon surface contacts the patient (e.g., see Figure 1 Calcified lesions in the vasculature of the patient 20) (see, for example, Figure 1 calcified lesion 50 shown). The medical device may include one or more pressure wave transmitters (e.g., see pressure wave transmitter 206 shown in FIG. 2 ) positioned along the central longitudinal axis of the elongated body within the balloon, the one or more pressure wave transmitters being configured to propagate at least one pressure wave through the fluid to disrupt the calcified lesion. In some examples, at least one of the pressure wave transmitters includes an optical fiber configured to transmit laser energy into the balloon (e.g., see Figure 8 According to some examples, the laser energy is configured to generate cavitation bubbles in the fluid upon contact with the fluid to generate at least one pressure wave.

[0009] The foregoing and other features and advantages of the invention will be apparent from the following more particular description of the preferred embodiments of the invention, the accompanying drawings, and the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] These and other features, aspects and advantages are described below with reference to the accompanying drawings, which are intended to illustrate rather than limit the present invention. In the accompanying drawings, like characters consistently denote corresponding features throughout like embodiments.

[0011] Figure 1 Illustrated is a diagrammatic view of an intravascular lithotripsy system (IVL) as it may appear inserted into a patient's vasculature.

[0012] Figure 2A and Figure 2B Two diagrammatic views of a medical device in or near a calcified lesion in a blood vessel are illustrated.

[0013] Figure 3 is a diagram illustrating an IVL system.

[0014] Figure 4 Pictured Figure 3 An embodiment of an IVL system as it might appear in a use case scenario.

[0015] Figure 5 A laser energy source system (such as Figure 1 generator, etc.) block diagram.

[0016] Figure 6 Illustrated is a side view of an exemplary IVL catheter including an IVL balloon at the distal end and a connector for coupling the IVL catheter to a generator.

[0017] Fig. 7A and Figure 7B Pictured Figure 6 Two cross-sectional views of a medical device in FIG.

[0018] Figure 8 Together with the diagram according to Figure 6 Insertion of the distal fiber tip of the IVL catheter Figure 1 The figure shows a stereoscopic view of an IVL balloon.

[0019] Fig.9A and Fig. 9B Illustrated is a perspective view of a portion of an IVL catheter at the distal fiber ends of two optical fibers, according to some examples.

[0020] Fig. 10A , Fig. 10B , Fig. 10C as well as Fig. 10D Illustrations of an IVL device wherein the distal fiber end of an optical fiber is held in place with or without a target having differently shaped profiles.

[0021] Fig.11A , Fig. 11B , Fig. 11C as well as Fig.11D Figure 1 shows an outline view of three possible configurations of a fiber positioner for holding an optical fiber in place. Figures 10A-10D As depicted in .

[0022] Fig.12 Illustrated is a diagram of two optical fibers traversing an IVL catheter along a guidewire lumen and terminating inside an IVL balloon, according to some examples.

[0023] Fig.13 An outline view of a shield used to protect the balloon from the optical fiber is shown.

[0024] Fig.14A and Fig. 14B Shown is a perspective view of a single optical fiber traveling along an IVL catheter and the cavitation bubble formed at the distal optical fiber tip.

[0025] Fig.15 Pictured Fig.14A and Fig. 14B A cross-sectional view of the elongated body and optical fiber.

[0026] Fig.16A and Fig. 16B A perspective view of a single optical fiber running along an IVL catheter is shown with scores cut into the optical fiber.

[0027] Fig.17 Pictured Fig.16A and Fig. 16B A cross-sectional view of the elongated body and optical fiber.

[0028] Fig.18A , Fig.18B as well as Fig.18C Different perspective views of a multi-fiber embodiment of an IVL catheter are illustrated.

[0029] Figures 19A-19H Illustrated are side views of different distal fiber ends of an optical fiber as may be provided in an IVL catheter.

[0030] Fig. 20 A flow chart depicting a method of generating cavitation bubbles in a balloon catheter is illustrated.

[0031] Fig.21 A flow chart depicting a method of generating cavitation bubbles within a container is illustrated.

[0032] Parts Index

[0033] 10-Intravascular Lithotripsy (IVL) System

[0034] 12-Medical Devices

[0035] 14-Access Point

[0036] 20-Patient

[0037] 30-Container

[0038] 40- Treatment Area

[0039] 50-Calcified lesions

[0040] 204-Balloon

[0041] 206-Pressure Wave Transmitter

[0042] 206a-Pressure Wave Transmitter

[0043] 206b-Pressure Wave Transmitter

[0044] 206c-Pressure Wave Transmitter

[0045] 206d-Pressure Wave Transmitter

[0046] 206e-Pressure Wave Transmitter

[0047] 208-Central Lumen

[0048] 212-Fluid

[0049] 302-Slender body

[0050] 304-proximal elongated body portion

[0051] 306-distal elongated body portion

[0052] 308-Central longitudinal axis

[0053] 310-Generator

[0054] 312-Connector

[0055] 402-Power Supply

[0056] 404-Console

[0057] 406-Test line

[0058] 408-Power Cord

[0059] 502-Laser Energy Source System

[0060] 504-Flashlight Power Supply

[0061] 506-Lamp lead

[0062] 508-Laser Head

[0063] 510-Opener

[0064] 512-Fiber Output

[0065] 514-Light

[0066] 516 Power on

[0067] 518 - Central Processing Unit (CPU)

[0068] 520-Button

[0069] 522-Pressure Sensor

[0070] 524-Fiber Optic Inquiry Agency

[0071] 702-Inner balloon surface

[0072] 704-External balloon surface

[0073] 706-Metallic coating

[0074] 802-Fiber

[0075] 802a-Fiber

[0076] 802b-Fiber

[0077] 902-Target

[0078] 902a-Target

[0079] 902b-Target

[0080] 902c-Target

[0081] 1002-Fiber Optic Positioner

[0082] 1002a-Fiber Optic Positioner

[0083] 1002b-Fiber Optic Positioner

[0084] 1002c-Fiber Optic Positioner

[0085] 1102-Marking tape

[0086] 1102a-Marking tape

[0087] 1102b-Marking tape

[0088] 1302-Shield

[0089] 1402- Distal fiber end

[0090] 1404-Cavitation bubbles

[0091] 1502-core

[0092] 1504-Clad

[0093] 1602-Scratched

[0094] 1902-Frustum of cone

[0095] 1904-conical parts

[0096] 1906-Convex lens

[0097] 1908-Concave lens

[0098] 1910-Spherical ball lens

[0099] 1912 - Diffuser Tip

[0100] 1914 - Side-Firing Tip

[0101] 1916 - Angled Ends DETAILED DESCRIPTION

[0102] Although specific examples are disclosed below, the subject matter of the invention extends beyond these specifically disclosed examples to alternative examples and / or their uses and modifications and equivalents. Therefore, the scope of the appended claims is not limited by any specific examples described below. For example, in any method or process disclosed herein, the actions or operations of the method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Different operations may be described as multiple discrete operations in sequence in a manner that may help understand the specific examples; however, the order of description should not be interpreted as implying that the operations are order-dependent. In addition, the structures, systems, and / or devices described herein may be implemented as integrated or separate components.

[0103] For the purpose of comparing different examples, certain aspects and advantages of these examples are described. Not all such aspects or advantages must be achieved by any particular example. Thus, for example, various examples may be performed in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages that may also be taught or suggested herein.

[0104] In an intravascular lithotripsy (IVL) procedure, clinicians use the formation and subsequent collapse of cavitation bubbles to generate high energy pressure waves to destroy calcified plaque lesions within a patient's vasculature. A typical IVL procedure involves generating shock waves via an electrode transmitter or electrode pair. Such systems can have a large cross-profile and increased manufacturing complexity.

[0105] Conventional IVL catheters also lack the ability to finely control the directionality of delivered energy. Using optical fibers to generate cavitation bubbles can help correct these shortcomings of prior art devices and increase delivered power, which can enhance treatment efficacy, improve consistency of energy delivery, increase durability of the IVL catheter as a whole, and reduce manufacturing costs due to its lower complexity.

[0106] The present disclosure describes systems and techniques for generating and directing high energy intravascular pressure waves for fragmentation and / or disintegration of calcified lesions within a patient's vasculature. For purposes of illustration, the techniques herein are primarily described with respect to optical (e.g., laser) based systems and their respective applications (such as coronary vascular applications, etc.). However, it should be understood that it can be assumed that the techniques described herein are equally applicable to similar systems based on other forms of energy (such as electrical based systems, etc.) and corresponding applications (such as peripheral therapy applications, etc.), unless expressly noted below. In addition, although treatment sites are described throughout this specification as including calcified lesions, it should be understood that the present disclosure also enables the treatment of restenotic lesions.

[0107] The system described herein generally includes an energy source, an IVL catheter with a distal IVL device, and an optical fiber. In some examples, the system includes an interventional balloon. During the lesion-disintegration operation, the clinician can advance the interventional balloon to the target treatment site in the patient's vascular system and inflate the balloon with an inflation fluid (such as a saline / contrast agent-fluid mixture, etc.) until the balloon contacts at least a portion of the local vessel wall. The saline / contrast agent-fluid mixture should be understood to include a viscosity suitable for forming cavitation bubbles by introducing electrical energy or light energy. Because the saline / contrast agent-fluid mixture often mixes during treatment, the ratio between saline and the contrast agent may fluctuate. Nevertheless, laser-based energy delivery may be relatively insensitive to these changes. The clinician can then actuate the energy generator so that the catheter produces cavitation bubbles in the fluid-filled balloon, causing high-energy pressure waves to propagate through the balloon and calcified lesions. The second pressure wave can also be caused by the subsequent collapse of the fluid cavitation, further destabilizing the internal structure of the lesion.

[0108] In an example that does not include an interventional balloon, a saline / contrast-fluid mixture is discharged into the patient's vasculature near the treatment site to displace the blood in the local area. Once the saline / contrast-fluid mixture has at least partially displaced the blood in this area, the clinician can actuate the energy generator, causing the catheter to generate cavitation bubbles in the area of ​​the saline / contrast-fluid mixture, thereby propagating high-energy pressure waves through this area and into the calcified lesion.

[0109] Additional examples with and without an interventional balloon include the introduction of a photosensitizer into the saline / contrast-fluid mixture. The photosensitizer can provide a target for the energy source to aim at, allowing for better control of where cavitation bubbles form within the interventional balloon and / or the saline / contrast-fluid mixture that has displaced blood in the local area.

[0110] As used herein, "superheating" refers to heating a liquid under pressure to above its boiling point without evaporating. In some examples, the devices as disclosed in the present application do not superheat the fluid within the balloon to form cavitation bubbles. In alternative examples, the devices of the present disclosure superheat the fluid within the balloon in order to form these cavitation bubbles.

[0111] Figure 1 A diagrammatic view of an intravascular lithotripsy system (IVL) 10 is illustrated as it may appear to be inserted into the vasculature of a patient. The IVL system 10 may include a medical device 12, which may include an interventional balloon, as shown in the following figures. During a lesion disintegration procedure, a clinician may advance the medical device through an access point 14 in a patient 20, such as a femoral artery or common femoral artery, as shown in the following figures. Figure 1Other access points may include the radial artery, tibial artery, pedal artery, axial artery, celiac artery, etc. The medical device 12 may then be advanced through the vasculature of the patient 20 until it reaches the blood vessel 30 containing the treatment area 40. For IVL, the treatment area may include a calcified lesion 50. Figure 2A and Figure 2B Close-up views of two examples of an IVL system positioned in or near a treatment area 40 including a calcified lesion 50 are shown.

[0112] Figure 2A A schematic diagram of a medical device 12 within a treatment area 40 including a calcified lesion 50 in a blood vessel 30 is illustrated. In this example, the medical device 12 includes a balloon 204. During an IVL procedure, the clinician can inflate the balloon 204 so that it physically contacts at least a portion of the calcified lesion 50 and the wall of the blood vessel 30 in the treatment area 40. Such inflation of the balloon 204 can include the use of a saline / contrast-fluid mixture for propagating a pressure wave or "shock wave" when superheated by the laser. Such a saline / contrast-fluid solution can be any percentage ratio as no discernible differences were observed during testing. Although any saline / contrast-fluid solution can be used, it may be desirable to include at least a small percentage of contrast-fluid in the solution as saline does not show up under fluoroscopic guidance and, therefore, does not indicate inflation or inflation-related problems to the operator. As will be described in detail below, the present invention relates to a method for performing an IVL procedure in which a saline solution is used. Figure 10A-10B As discussed in , specific wavelengths of laser energy are able to superheat the saline / contrast-fluid mixture without assistance ( Fig. 10A ). Nevertheless, other wavelengths are less absorbed in the saline / contrast-fluid mixture and may require a target stopper that overheats and causes pressure wave deployment.

[0113] Figure 2A Also shown is the central lumen 208 located within the elongated body (302 below). Along the elongated body 302 is the pressure wave transmitter 206. Figure 2A and Figure 2B As shown, five pressure wave transmitters (206a, 206b, 206c, 206d, 206e) are present in the medical device 12. Figure 2A and Figure 2B 206, but the array of emitters 206 of the medical device 12 may include as few as one individual emitter unit 206 and as many emitter units 206 as may reasonably fit within the balloon 204. It should also be noted that throughout this disclosure, individual emitter units 206 are also referred to as "emitters" 206 (e.g., with respect to the emitter unit 206 as a whole).

[0114] Figure 2BA schematic diagram of a medical device 12 is shown adjacent to a treatment area 40 including a calcified lesion 50 in a blood vessel 30. The medical device 12, balloon 204, and pressure wave transmitter 206 may be similar to Figure 2A However, Figure 2B The central lumen 208 of the elongated body 302 is shown for deploying or injecting a fluid 212 into the treatment area 40. The fluid 212 can displace blood in the treatment area 40 prior to inserting the medical device 12 into the treatment area 40, facilitate inflation of the balloon 204 and improve the efficacy of the IVL procedure.

[0115] Figure 3 is a diagram illustrating an IVL system 10. Figure 3 As shown, the IVL system 10 can include at least an energy generator 310 and an elongated body 302 removably coupled to the energy generator 310, for example, via an electrical connector 312. The elongated body 302 can include a medical device 12 positioned at a distal elongated body portion 306. In some examples, the elongated body 302 is configured to navigate the tortuous vasculature of the patient 20 toward a target treatment site 40 (e.g., a calcified plaque lesion 50 within the blood vessel 30).

[0116] Although the term "elongated body" is used throughout this specification, it should be understood that the elongated body may refer to a guiding tube, such as an IVL catheter, etc. Figure 3 The connector 312 is described as an electrical connector 312 in the description of FIG. 1 , but it should be understood that the connector 312 may also be an optical connector 312. In fact, in some examples, the IVL system 10 may not require an electrical connector 312. In these examples, the treatment button may be present on the console, and there may be no electrical interrogation of the catheter itself. Although the electrical connector 312 may not be required in all examples, the optical connector 312 is required in order to provide laser energy to the catheter.

[0117] like Figure 3 As shown, the medical device 12 can include a fluid-inflatable interventional balloon 204 and an array of pressure wave transmitters 206 (shown but not labeled due to size constraints) positioned within the balloon 204. The transmitter 206 array can include one or more individual transmitter units 206. For example, the interventional balloon 204 or a distal elongated body portion 306 through the interventional balloon 204 can define a central longitudinal axis 308, and the transmitter units 206 can be distributed longitudinally along the central longitudinal axis 308.

[0118] Each transmitter unit 206 is configured to receive energy from an energy generator 310 and use the received energy to generate and transmit high energy pressure waves through the balloon 204 and through the treatment site. As described in further detail below, the energy generator 310 can generate and transmit energy in the form of electrical energy, light energy, or a combination thereof. For example, the transmitter unit 206 can use the received energy to generate cavitation bubbles 1404 within the fluid within the balloon 204, thereby propagating one or more high energy pressure waves radially outward through the balloon and the calcified lesion.

[0119] In some cases, but not all, a second set of high energy pressure waves may subsequently be caused by the collapse of the fluid cavitation bubbles 1404 (as shown in FIG. 14 ), further destabilizing the internal structure of the calcified plaque lesion. In some examples, the one or more transmitters 206 may include a light-based transmitter 206 configured to transmit the calcified plaque lesion to the patient, such as via one or more optical fibers 802 (e.g., Figure 8 310) receives a high energy optical (e.g., light) signal from a generator 310 and directs the optical signal to trigger initial cavitation. In addition, one or more emitters 206 may include an electrical-based emitter 206 configured to receive electrical energy from the generator 310, such as via one or more wires, and generate a spark between a pair of electrodes, thereby triggering initial cavitation.

[0120] According to some examples, a cooling mechanism operates in series with the energy generator 310. However, a flash lamp system can provide energy to the optical fiber 802 without the need for such a cooling mechanism. Additionally, a diode system can be used as an alternative to a flash lamp system, which also may not require a cooling mechanism.

[0121] Figure 4 Pictured Figure 3 10 as it might appear in use. A medical station can be provided to facilitate movement of the IVL system 10 between rooms (if necessary). The power supply 402 can be located near the base of the medical station, coupled to a power cord 408 for receiving wall power or power from the generator 310, and an umbilical cord for electrically coupling to the console 404. Figure 4 As shown, the console 404 allows a user (e.g., a clinician) to operate the IVL system 10. The elongated body 302 can be coupled to the console 404 via a power cable for receiving energy from the power source 402 to transmit energy to the transmitter 206 within the IVL balloon 204. There can also be a separate line dedicated to the inflation of the IVL balloon 204.

[0122] According to some examples, there is a detection line 406. The detection line 406 can provide some method of providing feedback on the integrity of the various components within the IVL balloon 204. For example, a safety pressure sensor can be provided. If a sudden pressure drop is detected, a failure may have occurred, such as a rupture of the IVL balloon 204. 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 vasculature. According to some examples, once the pressure sensor in the IVL balloon 204 detects a rupture of the balloon 204, the energy emission through the slender body 302 can be immediately stopped. It should be understood that the term "stop" can be used to issue an error code to the operator for a manual shutdown or an automatic system shutdown.

[0123] Additionally, the pressure sensor may be present anywhere within the pressure pathway, wherein the pressure pathway defines a path that begins at the generator and ends at the balloon 204. In some examples, the pressure sensor may be within the generator 310. According to some examples, the pressure sensor may be within a centerpiece, which is an intermediate component that connects the elongated body 302 to the generator 310 (in examples that include a separate generator 310). The pressure sensor may be present within the elongated body 302. In some examples, as described in the preceding paragraphs, the IVL balloon 204. The pressure sensor may be present outside of these various components (generator 310, hub, elongated body 302) but within the pressure pathway.

[0124] Additionally, in some examples, the pressure sensor may be present anywhere within the IVL system 10, including outside of the previously described pressure pathway. This may include a separate device external to the medical device 12, such as an inflation device that is part of or attached to a centerpiece connector, etc. The inflation device may be adjacent to the guidewire lumen 208 but external to the guidewire lumen 208. The pressure sensor may be part of or attached to such an inflation device.

[0125] In addition, there may be a fiber interrogation mechanism. According to some examples, the purpose of the fiber interrogation mechanism is to sense or detect the fiber or at least one of the fibers 802 (see Figure 8 ) has broken or otherwise become disconnected. This can be accomplished by reflecting at least a portion of the energy back into the optical fiber 802 once the pulse has been emitted, and any obstruction of this return pulse will indicate to the clinician that something has become brittle and the IVL balloon 204 should be retrieved and the problem solved.

[0126] Figure 5A block diagram of a laser energy source system 502 according to some examples is illustrated. As can be seen by the dashed lines surrounding most of the components, the laser energy source system 502 includes an energy source. Power (such as from a wall outlet, as shown by the arrow leading through 120V (IN)) can be provided to a power supply 402 within the energy source. The power supply 402 provides power to 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.

[0127] The CPU 518 includes a user interface that may involve tactile buttons and switches or other user communication means, such as a touch screen, etc. The power on switch 516 is shown in electronic communication with the CPU 518 and a button 520 that is used to reset the CPU 518 (Reset) and begin treatment (Treatment) once the elongated body 302 is in the proper position. The CPU 518 also controls lights 514 (ON, RDY, E, and F). The ON light 514 indicates that the system 502 is turned on. The RDY light 514 indicates that the system 502 is connected and ready to actuate laser energy. The E light 514 indicates that the laser energy is currently active. The F light 514 indicates that a fault has occurred and the system 502 needs to be reset. In an IVL system 10 that includes a safety feature (such as a safety pressure sensor as described above), the CPU 518 receives this feedback from a pressure sensor 522 that is external to the energy source when it is located in the IVL balloon 204.

[0128] 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 is aimed at a shutter 510, which is in electronic communication with and controlled by a CPU 518. The shutter 510 is an additional safety feature that prevents premature emission of laser light through the elongated body 302. The shutter 510 is commanded by the CPU 518 just before the flash lamp is triggered (which 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 spaces the laser head 508 from the optical fiber 802, as indicated by the optical fiber output 512. The optical fiber 802 then travels the length of the elongated body 302 to the treatment site. In the IVL system 10, including safety features such as the optical fiber interrogation mechanism as described above, the CPU 518 receives feedback from the optical fiber 802 through the optical fiber interrogation mechanism 524, as shown. Because the fiber optic interrogation mechanism can be operated from anywhere along the fiber optic line (a break anywhere in the line can be detected anywhere else along the line as long as the detection occurs before the break), the fiber optic interrogation mechanism 524 is shown as being conveniently located within the energy source.

[0129] Figure 6A side view of an example elongated body 302 is illustrated, including an IVL balloon 204 at a distal elongated body portion 306 and a connector 312 for coupling the elongated body 302 to a generator 310. In some examples, the elongated body 302 includes an inner shaft and an outer shaft surrounding the inner shaft. The inner shaft can include a guidewire lumen 208 or another type of lumen 208, depending on the needs of the clinician.

[0130] according to Figure 6 , there may be an IVL balloon 204. When the elongated body 302 has advanced to the treatment site, the IVL balloon 204 may be inflated with a saline / contrast-fluid mixture. Within the IVL balloon 204 is at least one emitter. As previously described, there may be as few as a single emitter 206 (e.g., Fig.14A , Fig. 14B , Fig.16A as well as Fig. 16B ), or there may be multiple transmitters 206 (such as Fig.18A , Fig.18B as well as Fig.18C ).

[0131] According to some examples, a single emitter (such as an optical fiber) may be scored to produce multiple locations for laser light or signal emission, thereby allowing a single optical fiber 802 to functionally act as multiple emitters 206. Fig.14A and Fig. 14B Such embodiments are explored in more detail in .

[0132] At the proximal elongated body portion 304, the connection point between the elongated body 302 and the generator 310 can be seen. This connection point can occur by directly coupling the elongated body 302 to the generator 310 or an adapter adapted to couple one end to the elongated body 302 and the opposite end to the generator 310. At the proximal elongated body portion 304, there can also be a fiber optic bundle in examples where multiple optical fibers 802 are used as the emitter 206. The fiber optic bundle is in optical communication or optically coupled to the generator 310 to provide the optical fibers 802 with laser energy to be emitted into the fluid-filled IVL balloon 204.

[0133] As previously disclosed, in some examples, the IVL balloon 204 may not have an elongated body 302, nor is it necessary. In these embodiments, the inner shaft may include a lumen 208 configured to deliver a saline / contrast-fluid mixture to a treatment region of the vasculature. The introduction of such a saline / contrast-fluid mixture may displace local blood in such vasculature, thereby allowing the energy emitted by the optical fiber 802 to generate cavitation bubbles 1404 without the need for an external structure like the IVL balloon 204.

[0134] Fig. 7A and Figure 7B The figure shows Figure 6 Two cross-sectional views of the medical device 12. Specifically, Fig. 7A The balloon 204 is shown having a metallized coating 706 on the interior balloon surface 702, and Figure 7B The balloon 204 is illustrated having a metallized coating 706 on the outer balloon surface 704 . Fig. 7A and Figure 7B Both also show the elongated body 302 and the central lumen 208. The radii and proportions of each feature are exaggerated to simplify the representation of each individual structure in the figures.

[0135] The metallized coating 706 can be configured to increase the damage threshold of the balloon 204 due to laser energy. That is, due to the presence of the metallized coating 706 on the inner balloon surface 702 or the outer balloon surface 704, the resistance of the balloon 204 to perforation and collapse caused by too much laser energy may be increased. The metallized coating 706 can also provide an additional safety measure in the event that the balloon 204 fails or deflates. The metallized coating 706 can prevent the optical fiber (802 below) from contacting or penetrating the balloon 204. Without additional safety measures, if the balloon is perforated during the procedure, there is a possibility that balloon fragments may be inadvertently left in place, and then these fragments may migrate through the patient's blood vessels. In addition, this additional measure can help prevent unwanted balloon deflation.

[0136] The metallized coating 706 can be produced from aluminum, nickel, chromium, gold, alloys, dielectric reflective coatings, etc. It should be understood that the list of metallized coatings 706 is not comprehensive, and equivalent metallized coatings 706 can be used, although not named herein. The metallized coating 706 can be deposited in extremely thin layers. These layers can be only a few microns thin, making the metallized coating 706 almost transparent and allowing the thinnest possible variation in the thickness of the balloon 204 while still obtaining the benefits listed herein.

[0137] exist Fig. 7A and Figure 7B In both cases, the metallized coating does not significantly change compliance or any other balloon properties. The additional thickness added to the balloon 204 may depend on whether the metallized coating 706 is on the inner balloon surface 702 or the outer balloon surface 704. For example, in Fig. 7A In the embodiment of the present invention, the metallized coating 706 can be folded, which can increase the thickness of the balloon 204 by up to two times. Figure 7B In the embodiment of the present invention, an additional layer can be located outside the metallized coating 706 on the outer balloon surface 704 to prevent particle migration. This can prompt the thickness of the balloon 204 to increase by up to six times.

[0138] Figure 8A perspective view and an insertion view of an IVL balloon 204 are shown, the insertion view illustrating the Figure 6 The distal fiber end (1402 below) of the optical fiber 802 of the slender body 302 is located. In this example and the following examples, any optical fiber 802 of the present invention acts as a pressure wave transmitter 206 as detailed in the previous figures. Figure 8 In an example of a protective sleeve, the protective sleeve can contain 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 can include a toe or blunt feature on its terminal portion to prevent accidental perforation of the balloon 204 by the optical fiber 802. It should be understood that such a toe or blunt feature does not hinder the passage of laser energy from the distal fiber end 1402.

[0139] Fig.9A and Fig. 9B A perspective view of a portion of the elongated body 302 at the distal fiber ends 1402 of two optical fibers 802 is illustrated according to some examples. At least one optical fiber 802 can terminate at least partially adjacent to a target 902. In the case of shorter wavelength emission, such as Nd:YAG lasers, etc., the target 902 can provide a safety feature and a component in the formation of cavitation bubbles 1404.

[0140] In terms of safety, the higher energy provided by the Nd:YAG laser can travel into the patient's vasculature after inducing cavitation (if uninterrupted). In such a case, and at sufficiently high energy levels, this could be harmful to the patient. In the absence of an IVL balloon 204, the target 902 can prevent the energy from exceeding the boundaries of the IVL balloon 204 and / or the effective treatment area.

[0141] With respect to the formation of cavitation bubbles 1404, the target 902 may receive the energy emitted by the optical fiber 802 and begin to heat. As the target 902 further heats, cavitation bubbles 1404 may form on the target 902. In this case, the wavelength of the laser light is neither absorbed by nor intended to be absorbed by the saline / contrast-fluid mixture, because all of the energy may be transferred into the target 902 to promote the generation of superheated cavitation bubbles 1404 on the surface of the target 902, which are generated due to the subsequent heating of the surrounding saline / contrast-fluid mixture.

[0142] Fig. 10A , Fig. 10B , Fig. 10C as well as Fig. 10DA diagram of the medical device 12 with the IVL balloon 204 is shown, wherein the distal fiber end 1402 of the optical fiber 802 is held in place by the fiber positioner 1002 while being aimed at the target 902.

[0143] Fig. 10A A side view of a medical device 12 without a target is shown. In this example, the wavelength of the energy from the laser causes the saline / contrast-fluid mixture to superheat from the laser itself, propagating cavitation bubbles without the need for an additional component in the form of a target. Figure 10B-10D In the present invention, various other wavelengths of laser energy may be used because 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 superheat, causing the surrounding saline / contrast-fluid mixture to heat in turn and subsequently initiate the propagation of cavitation bubbles.

[0144] Fig. 10B A side view of a trapezoidal-shaped target 902a is shown, with the flat side facing the distal fiber end 1402 . Fig. 10C A side view of target 902b is shown as an elongated octagon where angled or sloped surfaces may be in the path of the optical signal. Fig. 10D An example of a target 902c having a fiber-facing surface that is tilted or angled relative to the angle of travel of the laser energy is shown. This angled surface can allow cavitation bubbles 1404 to be emitted substantially perpendicular to the angle of travel of the laser energy and toward the calcified lesion.

[0145] exist Fig. 10A , Fig. 10B , Fig. 10C as well as Fig. 10D In the elongated body 302 of the embodiment of the present invention, the optical fiber 802 is locked in place by the optical fiber positioner 1002. The optical fiber positioner 1002 can ensure that the relationship between the optical fiber 802 and the target 902 is consistent in terms of the distance between each other and the distance between the distal optical fiber end 1402 and the central lumen 208.

[0146] According to some examples, the optical fiber can be repositioned within the balloon 204, and thus the distance to the target 902 can be adjusted by the clinician. As described in other figures, this ability to reposition the optical fiber 802 is independent of the target 902 being present in the slender body 302. A sliding mechanism can be included in a handle or control interface coupled to the optical fiber 802, thereby allowing axial movement and control of the optical fiber 802. If the clinician wants to independently control each optical fiber 802 present in the slender body 302, a separate sliding mechanism can be included. If only a single optical fiber 802 is present in the slender body 302, only a single sliding mechanism may be required. Fig.11A , Fig. 11B , Fig. 11C as well as Fig.11D A fiber optic positioner is shown and described in .

[0147] Fig.11A , Fig. 11B , Fig. 11C as well as Fig.11D Figure 1 shows outline views of three possible configurations of fiber positioners for holding an optical fiber in place. Figures 10A-10D Specifically, Fig.11A Illustrated is a marker tape 1102 having a top component fiber locator 1002a that holds onto the optical fiber 802 and has a bevel at the end where the tip of the optical fiber can rest but not touch.Such a fiber locator 1002 can be injection molded or extruded.

[0148] Fig. 11B Pictured Fig.11A The fiber locator 1002b is a fiber locator 1002 of the embodiment of FIG. 1 , but without the marker band 1102. The fiber locator 1002b may also be extruded or injection molded, but due to the lack of the marker band 1102, the fiber locator 1002b may be attached to a preformed marker band 1102 or another component, such as with an adhesive. The fiber locator 1002b is radiused at the bottom to allow attachment to a circular mechanism, such as the elongated body 302, the marker band 1102, or another component.

[0149] Fig. 11C FIG. 1002 is another example of a fiber locator 1002c. The fiber locator 1002c is structurally similar to Fig.11A and Fig. 11B The fiber locator 1002c is simpler than those of the elongated body 302 because it does not include multiple apertures or rounded bottom portions. The fiber locator 1002c can remain in place relative to the elongated body 302, or can include a laser cut slit in its flared section to allow it to be curled down onto the elongated body 302, the marker tape 1102, or another component. Additional implementations include attaching the fiber locator 1102c to an internal mechanism (i.e., the elongated body 302, the marker tape 1102, etc.) via ultraviolet (UV) adhesive, heat shrink, or shimming the marker tape. It should be understood that these attachment implementations can also be used with Fig. 11B These attachment implementations are in Fig.11A The fiber locator 1002a is not necessary because in such an example the fiber locator 1002a and the marker band 1102 are molded together.

[0150] Fig.11DAnother example of a fiber locator 1002 is illustrated, shown as a marker band 1102b. In this example, there are two marker bands 1102—an inner marker band 1102a surrounding the guidewire lumen 208 and an outer marker band 1102b surrounding the inner marker band 1102a, and any existing optical fiber 802. Thus, the inner marker band 1102a spaces the optical fiber 802 from the guidewire lumen 208 by a predetermined distance, and the outer marker band 1102b holds the optical fiber 802 in place.

[0151] Although not present Figures 11A-11D But as follows Fig.13 A flared member similar to the shroud shown and described may be present Figures 11A-11D Such a horn can act as a safety feature, helping to prevent any laser energy from contacting the surface of the balloon or the guidewire lumen.

[0152] Fig.12 An illustration of two optical fibers 802 (denoted as optical fiber 802a and optical fiber 802b) traversing the elongated body 302 along the guidewire lumen 208 and terminating inside the IVL balloon 204 is shown according to some examples. Fig.12 908. As shown, the optical fiber 802a shown above the guidewire lumen 208 depicts an angled distal tip end. According to some examples, the angled distal tip end is at an angle greater than 114 degrees to the longitudinal axis of the guidewire lumen 208. In other words, if the distal optical fiber end 1402 travels substantially parallel to the vascular system through which it moves, the distal tip end can be at an angle greater than 24 degrees relative to a plane perpendicular to the longitudinal axis of the lumen 208. The angled distal tip end can help avoid laser energy from impinging on the outer surface of the guidewire lumen 208. This can help the safety of the guidewire lumen 208, ensure that all laser energy is delivered to the target 902, or both.

[0153] As can be seen in the optical fiber 802b below the guidewire lumen 208, the optical fiber 802b can also terminate radially eccentrically from the guidewire lumen 208. Similar to the angled distal tip end, the radially off-center termination optical fiber 802b can be convenient for avoiding laser energy impact on the outer surface of the guidewire lumen 208. The distance that the optical fiber 802b can present radially eccentrically from the guidewire lumen 208 depends on the diameter of the optical fiber and the position that allows the optical fiber 802b to begin bending. Larger bends in the optical fiber 802b may require larger balloons 204, which may be problematic for smaller diameter vascular systems.

[0154] Fig.13An outline view of a shield 1302 for protecting the balloon 204 from the optical fiber 802 is shown. The shield 1302 can be a laser cut nitinol structure bonded to a skirt made of any other material such as fabric, polymer, or flexibility. The skirt can inflate when the balloon 204 is inflated. The nitinol structure can include tines with curved ends to provide a smooth contact point with the balloon 204 to prevent accidental perforation of the balloon 204. The skirt can also be expanded using a different mechanism within a handle proximal to the elongated body 302.

[0155] As Fig.11A , Fig. 11B , Fig. 11C as well as Fig.11D , the shield 1302 can be used to protect the balloon 204 from the tip of the optical fiber 802, thereby preventing accidental perforation of the balloon 204. The shield 1302 can also be used with any optical fiber positioner 1002.

[0156] The solid portion of the shroud 1302 may be crimped or wrapped around the optical fiber 802, wherein the optical fiber 802 extends to a point just inside the portion where the skirt of the shroud 1302 begins. This will allow the nitinol structure ("arm") and skirt to collapse down around and past the tip of the optical fiber 802. While the shroud 1302 is presented as a 180 degree structure, it should be understood that the shroud 1302 may present any amount of circumferential coverage between 0 degrees (no coverage) and 360 degrees (full circumferential coverage).

[0157] Fig.14A and Fig. 14B A perspective view of a single optical fiber 802 traveling along an elongated body 302 and an elongated cavitation bubble 1404 generated at a distal optical fiber end 1402 is illustrated. Fig.14A The distal elongated body portion 306 is shown, while Fig. 14B A close-up view of the distal fiber end 1402 of the optical fiber is illustrated.

[0158] Although in Fig.14A and Fig. 14B306 , but in some examples, smaller cavitation bubbles 1404 may be produced. In either 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 examples including an IVL balloon 204, the optical fiber 802 may terminate within the IVL balloon 204. If a small cavitation bubble 1404 is used, the distal optical fiber end 1402 may be positioned at least partially concentric with the treatment site. Here, the cavitation bubble 1404 is formed by energy generation and subsequent energy guidance along the optical fiber. The energy is dissipated from the distal optical fiber end 1402 and then interacts with the saline / contrast agent-fluid mixture to produce a cavitation bubble. Once this cavitation bubble 1404 collapses, the shock wave is pushed radially away from the collapse point, impacting or penetrating the treatment site, and destroying any existing calcification.

[0159] In the case of elongated cavitation bubbles, e.g. Fig.14A and Fig. 14B As shown, the method is very similar. However, the difference lies in the pulse width and frequency that produces the Moses effect. The Moses effect is a spreading cavitation bubble. The shaped cavitation bubble 1404 enables subsequent laser energy to travel through the shaped cavitation bubble to deposit laser energy at the farthest end of the cavitation bubble 1404 (i.e., the end of the cavitation bubble 1404 farthest from the distal fiber end 1402). The cavitation bubble 1404 will continue to propagate and collapse through the length of the treatment site (areas of saline / contrast-fluid mixture, such as areas of the vasculature that have replaced blood or up to the length of the IVL balloon 204, etc.), thereby allowing treatment of lesions that are longer than a single cavitation bubble.

[0160] Target 902 (such as Fig. 9B , Fig. 10B , Fig. 10C as well as Fig. 10D ) will likely not be used in conjunction with an elongated body 302 implementing the Moses effect, as this would significantly limit the distance that the cavitation bubbles 1404 can propagate. In some examples, a longer wavelength energy source, such as Ho:YAG or CTH:Yag, may be used.

[0161] Fig.15 Pictured Fig.14A and Fig. 14B A cross-sectional view of the elongated body 302 and the optical fiber 802. Fig.15 As shown, optical fiber 802 includes core 1502 and cladding 1504. Cladding 1504 prevents laser energy from exiting optical fiber 802 from core 1502. Fig.15 does not exist in , but is in Figures 16A-18CShown and described in FIG. 1 are notches in the cladding 1504 to allow laser energy to flow out of the optical fiber 802 prematurely to the distal optical fiber end 1402, such as in some examples, such as Fig.14A , Fig. 14B as well as Fig.15 In the example of , the system may not allow the laser energy to leave the optical fiber 802 prematurely. Although not shown, according to some examples, the core may also be eventually scored a smaller amount. Similar to the above Fig. 7A and Figure 7B , the radius and scale of each feature are exaggerated to simplify the representation of each independent structure in the drawings.

[0162] Fig.16A and Fig. 16B A perspective view of a single optical fiber 802 is shown traveling along the elongated body 302, wherein a score 1602 is cut into the optical fiber. Specifically, Fig.16A The distal elongated body portion 306 is shown, while Fig. 16B A close-up view of two scores 1602 in optical fiber 802 is illustrated. Fig.16A and Fig. 16B Both show cavitation bubbles 1404 starting at score 1602 of optical fiber 802 .

[0163] like Fig.16A and Fig. 16B As shown, each notch 1602 presents an exit point for energy. This can effectively turn a single optical fiber 802 into a multi-emitter laser fiber. In these examples, the energy is reflected within the optical fiber 802 until it finds a natural end point through which it can be emitted, such as each of the notches 1602. Fig. 16B As shown, in addition to the notches 1602 , energy may also be released through the openings at the distal fiber end 1402 .

[0164] Similar to Fig.14A and Fig. 14B 1602, once the energy is emitted from the score, it reacts with the saline / contrast-fluid mixture to produce a cavitation bubble. This cavitation bubble 1404 will then collapse, resulting in a shock wave that impacts or penetrates the treatment area, thereby causing damage to any existing calcification. Similar to the Moses effect described above, the presence of multiple scores 1602 allows multiple cavitation bubbles 1404 to spread throughout the treatment area, thus extending the length of treatment that can be applied.

[0165] like Fig. 16B As shown, the distal fiber end 1402 can be used as an exit point, similar to Fig.14A and Fig. 14BThe distal fiber end 1402 can operate in the same manner as the distal fiber end 1402 of the single optical fiber 802, in that cavitation bubbles 1404 can be formed therein. Depending on the generator settings, such as pulse width and frequency, the Moses effect can be utilized at the distal fiber end 1402.

[0166] Fig.16A Five notches 1602 are shown, and Fig. 16B The two most distal scores 1602 are shown. There may be as few as one score or multiple scores 1602 (eg, scores 1602 that may fit within an IVL balloon 204, in examples that include an IVL balloon 204).

[0167] Fig.17 Pictured Fig.16A and Fig. 16B A cross-sectional view of the elongated body and optical fiber. Fig.15 , optical fiber 802 includes a core 1502 and a cladding 1504. The cladding prevents laser energy from leaving the optical fiber 802 from the core 1502 at unwanted locations. Fig.15 Different, cladding 1504 in Fig.17 is described as including notch 1602. As described above in Fig.16A and Fig. 16B In and below Fig.18A ,picture Fig.18B as well as Fig.18C The notches 1602 shown and described in the drawings allow the laser energy to exit the optical fiber 802 before the distal optical fiber end 1402. This premature emission can allow a plurality of cavitation bubbles 1404 to form along the body of the optical fiber 802, thereby increasing the length of effective treatment along the calcified lesion 50 in the treatment area 40. Similar to the above Fig. 7A , Figure 7B as well as Fig.15 , the radius and scale of each feature are exaggerated to simplify the representation of each independent structure in the drawings.

[0168] Fig.18A , Fig.18B as well as Fig.18C Various perspective views of embodiments of multiple optical fibers 802 of the elongated body 302 are shown. Figures 18A-18C In each of the figures, the termination point at the distal fiber end 1402 of each of the optical fibers 802 of the present invention depicts the beginning of a cavitation bubble.

[0169] according to 18A to 18C The slender body 302, each optical fiber 802 and Fig.14A and Fig. 14BThe elongated body 302 of the present invention functions similarly. Energy is transmitted from the generator 310 through each optical fiber. When energy is emitted from each distal optical fiber end 1402a, 1402b, 1402c, 1402d, it can interact with the saline / contrast agent-fluid mixture to produce cavitation bubbles 1404, as shown. Once the cavitation bubbles 1404 collapse, the shock waves are pushed substantially radially away from each collapse point, impacting and penetrating the treatment site and damaging any existing calcifications. Because there are multiple optical fibers 802, and the distal optical fiber ends 1402 are positioned at a certain distance from each other in the longitudinal direction, multiple cavitation bubbles 1404 can be formed along the length of the treatment area, thereby extending the size of the lesion that can be treated.

[0170] By controlling the pulse width and frequency of the delivered energy, the operator can also achieve a Moses effect from each optical fiber 802. However, the benefits of achieving this with multiple laser emitters 206 may be less efficient than with a single laser emitter, since multiple laser emitters 206 already achieve the goal of extending the treatment area.

[0171] Depending on the energy source used, a target 902 or multiple targets 902 may also be applied at the distal elongated body portion 306 to absorb the energy provided by the optical fiber 802. Fig. 9B , Fig. 10B , Fig. 10C as well as Fig. 10D 902, the target 902 may heat up due to the absorption of energy. As the target 902 continues to heat, cavitation bubbles 1404 may form on the target 902 due to the target heating the surrounding saline / contrast solution. In this case, the wavelength of energy may not be intended to be directly absorbed by the saline / contrast-fluid mixture. All of the energy may be delivered to the target 902 to promote the generation of superheated cavitation bubbles 1404 on the surface of the target 902 by the heat generated by the absorption of the saline / contrast-fluid mixture.

[0172] Although in Figures 18A-18C 1002. Although not shown, the optical fibers 802 may be locked in place by the optical fiber positioner 1002. The optical fiber positioner 1002 may ensure that the relationship between each distal optical fiber end 1402 and its associated target 902 remains consistent and that the distance each optical fiber 802 is offset from the central lumen 208 remains consistent.

[0173] Figures 18A-18C Each of the figures in FIG. 8 shows five optical fibers 802. There may be as few as one optical fiber 802 (such as Fig.14A and Fig. 14B) or an optical fiber 802 that may be mounted within the IVL balloon 204 (in examples that include the IVL balloon 204) or an optical fiber 802 that may be mounted within the vasculature being treated.

[0174] 18A to 18C The exemplary elongated body 302 of FIG. 1 shows optical fibers 802 surrounding a central lumen 208, wherein distal fiber ends 1402 terminate at different points along the central lumen 208. For example, the optical fibers 802 may be further spaced apart from one another, or the optical fibers 802 may be provided in a symmetrical arrangement around the central lumen 208. Any configuration may be used.

[0175] Although 18A to 18C A cross-sectional view is not shown, but it should be understood that the cross section may look similar to Fig.15 Unscored cross section or Fig.17 1602. In either case, the only change is the number of optical fibers 802 surrounding the elongated body 302.

[0176] In all Figures 14A-18C 802. In the embodiment of the present invention, it should be understood that the cavitation bubbles 1404 formed by any of the methods disclosed herein are considered to radiate substantially outward from the center of the elongated body 302, despite the presence of a short radius away from each optical fiber 802. The central lumen 208 does not interfere with the cavitation bubbles 1404 in any meaningful way. Therefore, each provided cavitation bubble 1404 is understood to radiate with complete or substantially complete 360 ​​degree coverage around the vessel wall. In examples where the central lumen 208 does produce some shadowing, the cavitation bubble 1404 will still radiate with 360 degree coverage around the vessel wall, but some variation in the magnitude of the intensity of the bubble around this perimeter may be observed.

[0177] Figures 19A-19H The diagrams illustrate side views of various distal fiber ends 1402 for optical fibers 802, such as may be disposed in the elongated body 302. In the example of a distal fiber end 1402 intended for collecting light or optical signals (e.g. Fig.19A , Fig.19C , Fig.19D , Fig.19E as well as Fig.19H ), the shape of the fiber tip at the distal fiber end 1402 can improve the capabilities of the aforementioned fiber interrogation mechanism 524. By using these different fiber tips to increase the probability that the light or optical signal reflected back at the optical fiber 802 is captured by the distal fiber end 1402, it becomes more likely that there will be no false negative reports of fiber problems, such as breaks, etc. Therefore, the clinician will not remove the elongated body 302 prematurely due to erroneous data reporting fiber problems.

[0178] In the example of a distal fiber end 1402 intended for emitting light or laser energy in a certain direction ( Fig.19B , Fig.19C , Fig.19D , Fig.19F as well as Figure 19G ), the shape of the fiber tip at the distal fiber end 1402 can facilitate directional discharge of the laser, redirection of the laser without using fiber bending or narrowing or widening the beam or light signal to affect the amount of energy delivered to the point.

[0179] It is worth noting that Fig.19C and Fig.19D The example shown in 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 optic tip includes functionality for improving both of these actions and thus can assist both the means of delivering the laser light and safety in the form of sensing the laser light reflected back, depending on the needs of the user.

[0180] Fig.19A The distal fiber end 1402 is shown including a truncated cone 1902 (increase in radial dimension) according to some examples. The truncated cone 1902 can increase the spot size of the laser to reduce the power density at the interface between the distal fiber end 1402 and the saline / contrast-fluid mixture or target 902. Fig.19B The distal fiber end 1402 is illustrated as having a taper 1904 (reduced radial dimension). The tapered 1904 profile can reduce the spot size of the laser and increase the flux or energy density of the laser.

[0181] Fig.19C An optical fiber 802 is shown having a distal fiber end 1402 including a convex lens 1906. The convex lens 1906 can increase light or optical signal collection from the laser while reducing divergence. Fig.19D The distal fiber end 1402 is illustrated including a concave lens 1908 according to some examples. The concave lens 1908 can increase the light or optical signal divergence of the laser.

[0182] Fig.19E An optical fiber 802 is illustrated having a distal fiber end 1402 that includes a spherical ball lens 1910. The spherical ball lens 1910 can increase the angle of potential light collection by the optical fiber. Fig.19F The distal fiber end 1402 is shown including a diffuser tip 1912. The diffuser tip 1912 can allow for full peripheral illumination through all sides of the distal fiber end 1402.

[0183] Figure 19GFiber 802 is shown wherein distal fiber end 1402 includes a side-firing tip 1914. The angle of side-firing tip 1914 redirects the laser light at least in part relative to the lateral angle of elongated body 302 passing through the vasculature. This redirection can be at any angle, including a substantially perpendicular angle, as well as a 180 degree redirection of the laser light. Fig.19H The distal fiber end 1402 is illustrated as including an angled end 1916. The angled end 1916 can reduce back reflections when collecting light or laser energy.

[0184] exist Figures 19A-19H In any of the figures in the drawings, in which the IVL balloon 204 is present on the elongated body 302, the polished distal fiber end 1402 terminates within the IVL balloon 204. The polished distal fiber end 1402 can be cut, shaped, or flame polished. In all examples (including the balloon 204), the rough edges of the distal fiber end 1402 may be undesirable because they may cause wear and tear on the inner wall of the balloon 204, which may reduce the life expectancy of the balloon 204. However, it should be understood that it is not required to polish the distal fiber end 1402 in any way without affecting the ability of the IVL system 10 as a whole.

[0185] Any energy source suitable for providing energy through the optical fiber 802 to generate cavitation bubbles by interaction with the saline / contrast-fluid mixture or the target 902 may be used with Figure 1-19H The example IVL system 10 depicted in FIG. 1 and any combination of features may be used. Some examples include using a laser medium such as Nd:YAG (neodymium-doped yttrium aluminum garnet), Ho:YAG (holmium), or CTH:YAG (chromium, thulium, holmium). Laser media such as Nd:YAG with a short wavelength (approximately 3124 nanometers for Nd:YAG) may benefit from using Fig. 9B , Fig. 10B , Fig. 10C and Fig. 10D Target 902 as described in. Laser media such as CTH:YAG with a longer wavelength (approximately 2.1 microns for CTH:YAG) can benefit from IVL system 10, where cavitation bubbles 1404 are formed by interaction with the saline / contrast agent-fluid mixture. In addition, different types of pump lasers can be used with Figure 1-19H Any of the example IVL systems 10 and features depicted in the drawings may be used together with a discharge-pumped excimer laser or a flash lamp-pumped laser, among others.

[0186] The sizes of the lasers provided include wavelengths ranging from 308 nanometers to 2.1 microns (examples include 308 nanometer excimer lasers and 355 nanometer tripled Nd:YAG lasers), but any suitable wavelength can be used. The pulse width can be "long" (about 300 to 600 microseconds) or short (less than 100 nanoseconds). The pulse repetition rate can be about 1-2 Hertz (HZ), but any pulse repetition rate can be used. Fiber 802 diameters include 150 microns, 175 microns, and 200 microns. Likewise, any functional fiber 802 diameter can be used. The energy level provided can be between 40 and 1500 millijoules (mJ), etc.

[0187] Fig. 20 A flow chart depicting a method of generating cavitation bubbles in a balloon catheter is illustrated. In some examples, the method includes providing a medical device according to the specification and drawings herein (at step 2000). The medical device may be as in Figure 1-19H The medical device shown and described in or any combination of these examples. According to some examples, the method includes placing a balloon adjacent to a calcified lesion within the vasculature of the patient (at step 2002). The balloon can surround or partially surround the distal end of the catheter.

[0188] The method may include inflating the balloon with a fluid (at step 2004). This inflation can be used for a variety of purposes. For example, inflating the balloon with a fluid can cause the balloon to contact a calcified lesion in the treatment area. In addition, if provided, the fluid used to inflate the balloon can be used as a container for energy entering from a laser source. In this case, the fluid can be a saline / contrast agent-fluid mixture of any percentage composition. In some examples, the method includes transmitting laser energy through an optical fiber (at step 2006). The laser energy is delivered through a catheter and toward the distal end of the catheter. The laser energy is intended to heat a target, which is a physical target (as described in step 2008b) or a fluid within the balloon (as described in step 2008a).

[0189] According to some examples, the method includes heating the fluid (at step 2008a). The laser energy is absorbed by the fluid, such as a saline / contrast agent-fluid mixture, and then the absorbed energy heats the fluid. The method may include generating cavitation bubbles (at step 2010). Due to the fluid heating, cavitation bubbles may form and then collapse. Such cavitation bubbles may generate high energy pressure waves that may be used to destroy calcified lesions in the treatment area.

[0190] Alternatively, in some examples, the method includes heating the target (at step 2008b). In this case, this physical target can act as a container for the laser energy. When the target heats, the target can transfer its heat to the surrounding fluid, causing the surrounding fluid to also heat. According to some examples, the method includes generating cavitation bubbles (at step 2010). In a similar manner as described above, cavitation bubbles can form and subsequently collapse due to fluid heating. To reiterate, the cavitation bubbles can then generate high energy pressure waves that can be used to destroy calcified lesions in the treatment area.

[0191] Fig.21 A flow chart depicting a method of generating cavitation within a container is illustrated. In some examples, the method includes providing a medical device according to the description and drawings herein (at step 2100). Again, the medical device can be as in Figure 1-19H The medical device shown and described in, or any combination of these examples. According to some examples, the method includes delivering a fluid through the central lumen (at step 2102). The provided fluid can be used to inflate the balloon (if present), such as Fig. 20 The provided fluid can also be used as a container for energy entering from a laser source, if provided. In this case, the fluid can be a saline / contrast agent-fluid mixture of any percentage composition.

[0192] The method may include emitting a fluid into the treatment area through the distal elongated body portion of the central lumen (at step 2104). In this case, there is no balloon, and the fluid is injected directly into the patient's vasculature. In some examples, the method includes displacing blood in the treatment area (at step 2106). This blood displacement can promote better contact between the fluid and the walls of the treatment area, allowing the pressure waves emitted from the collapsed cavitation bubbles to better destroy any calcified lesions present. By removing blood from the treatment area, the fluid can fill all or a majority of the treatment area.

[0193] According to some examples, the method includes transmitting laser energy through an optical fiber (at step 2108). Such laser energy can be delivered through a catheter and toward a distal end of the catheter. In some examples, the laser energy is intended to heat a target, which is a physical target (as described in step 2108b) or a fluid within a balloon (as described in step 2108a).

[0194] The method may include heating the fluid (at step 2110a). The laser energy may be absorbed by the fluid (such as a saline / contrast agent-fluid mixture, etc.), and then the absorbed energy heats the fluid. In some examples, the method includes generating cavitation bubbles (at step 2112). Due to the heating of the fluid, cavitation bubbles may form and then collapse. Such cavitation bubbles may generate high energy pressure waves that may be used to destroy calcified lesions in the treatment area.

[0195] Alternatively, according to some examples, the method includes heating the target (at step 2110b). In this case, this physical target can act as a container for the laser energy. When the target heats, the target can transfer its heat to the surrounding fluid, causing the surrounding fluid to also heat. The method can include generating cavitation bubbles (at step 2112). In a similar manner as described above, cavitation bubbles can form and subsequently collapse due to fluid heating. To reiterate - the cavitation bubbles can then generate high energy pressure waves that can be used to destroy calcified lesions in the treatment area.

[0196] Included in the present disclosure is a medical device 12 that includes an elongated body 302 having a distal elongated body portion 306 and a central longitudinal axis 308. According to some examples, the medical device 12 includes a balloon 204 positioned along the distal elongated body portion 306, the balloon 12 having an inner balloon surface 702 and an outer balloon surface 704 and configured to receive a fluid 212 to inflate the balloon 204 so that the outer balloon surface 704 contacts a calcified lesion 50 within the vasculature of the patient 20. The medical device 12 can include one or more pressure wave transmitters 206 positioned within the balloon 204 along the central longitudinal axis 308 of the elongated body 302, the one or more pressure wave transmitters 206 configured to propagate at least one pressure wave through the fluid 212 to fragment the calcified lesion 50. In some examples, at least one of the pressure wave transmitters 206 includes an optical fiber 802 configured to transmit laser energy into the balloon 204. According to some examples, the laser energy is configured to form cavitation bubbles 1404 in the fluid 212 upon contact with the fluid 212 to generate at least one pressure wave.

[0197] The optical fiber 802 can terminate near the distal elongated body portion 306. In some examples, the medical device 12 further includes a laser energy generator 310, wherein the laser energy generator 310 is configured to selectively pulse the laser energy. According to some examples, the pulsed laser energy is configured to produce a Moses effect.

[0198] The medical device 12 can further include a plurality of optical fibers 802, each configured to transmit laser energy and terminating at a distal fiber end 1402 at a different distance along the distal elongated body portion 306. In some examples, the laser energy is emitted from the distal fiber end 1402.

[0199] According to some examples, the optical fiber 802 includes a core and a cladding. In some examples, the cladding is disposed around the core, and the laser energy is emitted from the core through a score placed in the cladding. The medical device 12 may also include a plurality of optical fibers 802 disposed around the distal elongated body portion 306.

[0200] In some examples, the laser energy is configured to have a wavelength between about 1900 nanometers (nm) and 2100nm. According to some examples, the wavelength is about 2000nm. The isotopes of the doping elements may cause some small extensions of the wavelength, and the doping concentration in the crystal may also slightly shift the wavelength. Because of this, "about" as used herein in conjunction with "wavelength" is intended to mean ± 30nm. In some examples, the wavelength is between 1970nm and 2030nm. In the example using a CTH:YAG laser, the wavelength can be selected from 1970nm, 2030nm, 2080nm, 2091nm, 2097nm and 2121nm. In the example using a Ho:YAG laser, the wavelength can be about 2100nm.

[0201] In some examples, the laser energy is configured to have an energy between about 40 mJ and about 1500 mJ. According to some examples, the laser energy has a pulse width between about 10 nanoseconds and about 600 microseconds. The laser energy can have a pulse repetition frequency between about 1 Hz and about 2 Hz.

[0202] In some examples, the medical device 12 further includes a Nd-YAG laser configured to provide laser energy. According to some examples, the medical device 12 further includes a holmium laser selected from Ho:YAG and CTH:YAG, the holmium laser configured to provide laser energy. The medical device 12 may also include an excimer laser configured to provide laser energy.

[0203] In some examples, the medical device 12 further includes a pressure sensor 522 configured to detect a rupture in the balloon 204, wherein the pressure sensor 522 is configured to stop the laser energy when a balloon rupture is detected. Such detection may also occur due to any pressure loss above a certain threshold. According to some examples, the medical device 12 further includes a fiber interrogation mechanism 524 configured to detect a break in the optical fiber 802.

[0204] The medical device 12 can further include a target 902 disposed distal to the optical fiber 802. In some examples, at least one of the pressure wave emitters 206 includes an optical fiber 802 configured to transmit laser energy into the balloon 204 and impact the target 902. According to certain examples, the target 902 is configured to heat when impacted by the laser energy, and the heat from the target 902 is configured to heat the fluid 212 causing the pressure wave emission. The medical device 12 can further include an optical fiber 802 having a distal optical fiber end 1402 and an optical fiber positioner 1002 to maintain a constant distance between the distal optical fiber end 1402 and the target 902 so that the laser energy transmitted into the balloon 204 will impact the target 902.

[0205] In some examples, the medical device 12 defines a central lumen 208 extending through the elongated body 302, the central lumen 208 having a proximal lumen end and a distal lumen end opposite the proximal lumen end. In some examples, the central lumen 208 is configured to deliver a fluid 212 to displace blood in a treatment region 40 adjacent to a calcified lesion 50 within the vasculature of the patient 20.

[0206] According to some examples, the balloon surface is selected from the group consisting of: an inner balloon surface 702 , an outer balloon surface 704 , and combinations thereof, the balloon surface further comprising a metallized coating 706 configured to increase a damage threshold of the balloon 204 .

[0207] None of the steps described herein are necessary or indispensable. Any step may be adjusted or modified. Other or additional steps may be used. Any part of any step, process, structure and / or device disclosed or shown in one embodiment, flow chart or example of this specification may be combined or used together with any other part of any step, process, structure and / or device disclosed or shown in different embodiments, flow charts or examples or replace any other part of any step, process, structure and / or device disclosed or shown in different embodiments, flow charts or examples. The embodiments and examples provided herein are not intended to be discrete and separate from each other.

[0208] The section titles and subtitles provided herein are non-limiting. The section titles and subtitles do not represent or limit the full scope of the embodiments described in the sections to which the titles and subtitles belong. For example, a section named "Topic 1" may include embodiments that do not relate to Topic 1, and embodiments described in other sections may be applied to and combined with the embodiments described in the "Topic 1" section.

[0209] The various features and processes described above can be used independently of each other or can be combined in different ways. All possible combinations and sub-combinations are intended to fall within the scope of the present disclosure. In addition, in some implementations, certain methods, events, states or process blocks may be omitted. 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 tasks or events described may be performed in an order different from the order specifically disclosed. Multiple steps may be combined in a single block or state. Example tasks or events may be performed serially, in parallel or in some other manner. Tasks or events may be added to the disclosed example embodiments or removed from the disclosed example embodiments. The example systems and components described herein may be configured differently from those described. For example, elements may be added, removed or rearranged compared to the disclosed example embodiments.

[0210] Conditional language used herein, such as, among others, "can," "could," "might," "may," "for example," and the like, unless expressly stated otherwise or otherwise understood in the context as used, is generally intended to convey that certain embodiments include (and other embodiments do not include) certain features, elements, and / or steps. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for determining whether such features, elements, and / or steps are included or will be performed in any particular embodiment with or without author input or prompting. The terms "comprising," "including," "having," and the like are synonymous and are used inclusively in an open-ended manner and do not exclude additional elements, features, actions, operations, and the like. Moreover, the term "or" is used in its inclusive sense (rather than in its exclusive sense) such that, for example, when used to connect a list of elements, the term "or" refers to some, all, or all of the elements in the list. Unless specifically stated otherwise, conjunctive language (such as the phrase "at least one of X, Y, and Z") is understood in context as generally used to convey that an item, term, etc. can be X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require that at least one of X, at least one of Y, and at least one of Z each be present.

[0211] The term "and / or" means that "and" applies to some embodiments and "or" applies to some embodiments. Therefore, A, B, and / or C can be replaced with A, B, and C written in one sentence and A, B, or C written 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 only A, some embodiments may include only B, some embodiments may include only C, and some embodiments may include A, B, and C. The term "and / or" is used to avoid unnecessary redundancy.

Claims

1. A medical device comprising: an elongated body having a distal elongated body portion and a central longitudinal axis; a balloon positioned along the distal elongated body portion, the balloon having an inner balloon surface and an outer balloon surface and configured to receive a fluid to inflate the balloon such that the outer balloon surface contacts a calcified lesion within the vasculature of a patient; as well as one or more pressure wave transmitters positioned within the balloon along the central longitudinal axis of the elongated body, the one or more pressure wave transmitters configured to propagate at least one pressure wave through the fluid to disrupt the calcified lesion; wherein at least one of the pressure wave transmitters comprises an optical fiber configured to transmit laser energy into the balloon, and Wherein the laser energy is configured to generate cavitation bubbles in the fluid when in contact with the fluid to generate the at least one pressure wave.

2. The medical device according to claim 1, wherein: The optical fiber terminates adjacent the distal elongated body portion.

3. The medical device according to claim 2, further comprising a laser energy generator, wherein: The laser energy generator is configured to selectively pulse the laser energy.

4. The medical device according to claim 3, wherein: The pulsed laser energy is configured to generate a Moses effect.

5. The medical device of claim 1 , further comprising a plurality of optical fibers, each optical fiber being configured to transmit laser energy and terminating at a distal optical fiber end at a different distance along the distal elongated body portion, in, The laser energy is emitted from the distal optical fiber end.

6. The medical device according to claim 1, wherein: The laser energy is configured to have a wavelength between approximately 2000 nm and 2200 nm.

7. The medical device according to claim 6, wherein: The wavelength is about 2100 nm.

8. The medical device according to claim 1, wherein: The optical fiber includes a core and a cladding, the cladding being disposed around the core, and wherein the laser energy is emitted from the core through scores placed in the cladding.

9. The medical device of claim 1, further comprising a plurality of optical fibers disposed about the distal elongated body portion.

10. The medical device according to claim 1, wherein: The laser energy is configured to have an energy between about 40 mJ and about 1500 mJ.

11. The medical device according to claim 1, wherein: The laser energy has a pulse width between about 10 nanoseconds and about 600 microseconds.

12. The medical device according to claim 1, wherein: The laser energy has a pulse repetition frequency between about 1 Hz and about 2 Hz.

13. The medical device of claim 1, further comprising a Nd-YAG laser configured to provide the laser energy.

14. The medical device of claim 1, further comprising a holmium laser selected from the group consisting of Ho:YAG and CTH:YAG, the holmium laser configured to provide the laser energy.

15. The medical device of claim 1, further comprising an excimer laser configured to provide the laser energy.

16. The medical device of claim 1, further comprising a pressure sensor configured to detect a rupture in the balloon, wherein The pressure sensor is configured to stop the laser energy upon detecting balloon rupture.

17. The medical device of claim 1, further comprising a fiber optic interrogation mechanism configured to detect a break in the optical fiber.

18. The medical device according to claim 1, further comprising a target disposed distally of the optical fiber, in, The optical fiber includes a distal optical fiber end and an optical fiber positioner, the optical fiber positioner is used to maintain a constant distance between the distal optical fiber end and the target so that the laser energy transmitted into the balloon will impact the target, wherein the optical fiber is configured to transmit laser energy into the balloon and impact the target, wherein the target is configured to heat when struck by the laser energy, and Wherein heat from the target is configured to heat a fluid causing emission of the pressure waves.

19. The medical device according to claim 1, wherein: The elongated body defines a central lumen extending therethrough, the central lumen having a proximal lumen end and a distal lumen end opposite the proximal lumen end, the central lumen being configured to transmit fluid to displace blood in a treatment area adjacent to a calcified lesion within the patient's vasculature.

20. The medical device according to claim 1, wherein: A balloon surface selected from the group consisting of the inner balloon surface, the outer balloon surface, and combinations thereof further comprises a metallized coating configured to increase a damage threshold of the balloon.

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