Parameter monitoring for an intravascular lithotripsy system

Abstract

Included in the present disclosure is a system, including an elongated body having a guidewire lumen. In some embodiments, the system includes a pressure wave emitter disposed about the elongated body and having an optical fiber configured to transmit laser energy into a fluid to create plasma, a cavitation, or both, in the fluid, such that the laser energy is configured to enable a pressure wave to be generated. According to some embodiments, the system includes a generator configured to couple with the pressure wave emitter and deliver the laser energy thereto via an optical pathway. The system may include a detector configured to detect i) an aspect of the laser energy along the optical pathway, ii) an aspect of the optical fiber, or iii) both.

Description

PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTPARAMETER MONITORING FOR AN INTRAVASCULAR LITHOTRIPSY SYSTEMCROSS REFERENCE TO RELATED APPLICATIONS

[0001] The entire contents of the following application are incorporated herein by reference: U.S. Provisional Patent Application No. 63 / 742,092; filed January 6, 2025; and entitled PARAMETER MONITORING FOR AN INTRAVASCULAR LITHOTRIPSY SYSTEM.Technical Field

[0002] The present disclosure relates to treatments for a calcified-plaque lesion in a patient’s vasculature.SUMMARY

[0003] 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.

[0004] Included in the present disclosure is a system, including an elongated body having a guidewire lumen. In some embodiments, the system includes a pressure wave emitter disposed about the elongated body and having an optical fiber configured to transmit laser energy into a fluid to create plasma, a cavitation, or both, in the fluid, such that the laser energy is configured to enable a pressure wave to be generated. According to some embodiments, the system includes a generator configured to couple with the pressure wave emitter and deliver the laser energy thereto via an optical pathway. The system may include a detector configured to detect i) an aspect of the laser energy along the optical pathway, ii) an aspect of the optical fiber, or iii) both.

[0005] In some embodiments, the elongated body includes an inner elongated structure, the inner elongated structure including the guidewire lumen. According to some embodiments, the pressure wave emitter is positioned along a central longitudinal axis of the elongated body. The aspect of the optical fiber may be a shattering of the optical fiber or a crack in the optical fiber.

[0006] In some embodiments, the detector includes an array of photodiodes located along the optical pathway configured to detect a change in photon radiation in the optical pathway that corresponds to the shattering of the optical fiber or the crack in the optical fiber. According to some embodiments, the system further includes a blast shield configured to protect thePCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTgenerator from debris, laser blast, or both, resulting from the shattering of the optical fiber or the crack in the optical fiber.

[0007] The system may further include a partial reflector located along the optical pathway, the partial reflector configured to reflect a portion of the laser energy. In some embodiments, the detector includes a power meter configured to receive the portion of the laser energy and measure an amount of the optical power thereof, so as to detect for a change in the detected amount of optical power from an expected amount, a previous amount, or both, by a predetermined tolerance. According to some embodiments, the power meter is disposed within a housing of the generator. The detector may include an array of photodiodes configured to receive the portion of the laser energy and measure an intensity thereof, so as to detect for a change in the detected amount of optical power from an expected amount, a previous amount, or both, by a predetermined tolerance.

[0008] In some embodiments, the system further includes a high reflector along the optical pathway. According to some embodiments, the detector includes a power meter, an array of photodiodes, or both. The power meter, the array of photodiodes, or both may be configured to receive leakage of the laser energy from a side of the high reflector opposite to where at least some of the laser energy is configured to be reflected from, wherein the optical pathway extends distally from the high reflector to the pressure wave emitter.

[0009] In some embodiments, the aspect of the laser energy is a pulse width. According to some embodiments, the detector includes an oscilloscope, the oscilloscope in communication with an array of photodiodes, so as to be configured to measure a pulse width of the laser energy via light intensity measurement by the array of photodiodes.

[0010] The aspect of the optical fiber may be a fiber interrogation. In some embodiments, the detector includes an ultrasonic device configured to determine a break in the optical fiber. According to some embodiments, the ultrasonic device includes a hydrophone. The detector may include an array of photodiodes configured to receive a back reflection of the laser energy from a distal end of the optical fiber, the back reflection indicative of the fiber interrogation. In some embodiments, the back reflection from the distal end of the optical fiber includes a Fresnel reflection.

[0011] According to some embodiments, the generator includes a laser head configured to generate the laser energy. The detector may be configured to determine an aspect of the laser head. In some embodiments, the aspect of the laser head is a temperature of the laser head. According to some embodiments, the detector includes a thermocouple, a resistancePCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTtemperature detector (RTD), a thermistor, or any combination thereof, each configured to measure the temperature of the laser head.

[0012] The aspect of the laser energy may be an ultrasound intensity. In some embodiments, the ultrasound intensity is indicative of a pressure of each pulse associated with the laser energy. According to some embodiments, the detector includes a hydrophone configured to measure i) the ultrasound intensity, ii) a refractive index change as a function of time, or iii) both. Measuring the pressure of each pulse may provide a feedback on whether the pressure wave being generated is appropriate for a treatment.

[0013] In some embodiments, the detector is configured to determine a humidity of an ambient environment i) about the system, ii) within the generator, or iii) both. According to some embodiments, the detector includes a hygrometer configured to measure the humidity.

[0014] The detector may be configured to determine an elastic modulus of a vessel wall within a subject. In some embodiments, the aspect of the optical fiber is a pressure on a distal end of the optical fiber that correlates with the elastic modulus of the vessel wall. According to some embodiments, the distal end of the optical fiber is configured to be positioned based on the elastic modulus of the vessel wall. The detector may be further configured to perform an intravascular ultrasound (IVUS) configured to map a treatment segment, so as to map a calcified lesion on the vessel wall.

[0015] In some embodiments, the detector is configured to determine a maximum acceleration experienced by the generator, the elongated body, the detector, the pressure wave emitter, or any combination thereof. According to some embodiments, the detector includes a gravityforce sensor, an accelerometer, or both.

[0016] The detector may be configured to determine a bubble formation within the fluid. In some embodiments, the bubble formation is indicative of an increased amount of gas in the fluid. According to some embodiments, the detector includes i) an x-ray device configured to measure the bubble formation, ii) an additional optical fiber configured to measure the bubble formation, or iii) both. The detector may include an array of photodiodes configured to detect light, thereby enabling detection of the bubble formation. In some embodiments, the array of photodiodes is configured to receive a back reflection from a distal end of the optical fiber. According to some embodiments, the back reflection from the distal end of the optical fiber includes a Fresnel reflection.

[0017] The detector may include an ultrasound device configured to measure an ultrasound intensity, and wherein the ultrasound intensity is indicative of the bubble formation. In some embodiments, the ultrasound intensity is indicative of a pressure of each pulse of the laserPCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTenergy. According to some embodiments, the detector includes a hydrophone configured to measure the ultrasound intensity, such that a change thereof is indicative of the bubble formation.

[0018] The optical fiber may be translatable along the elongated body. In some embodiments, the aspect of the optical fiber is a longitudinal position of a distal end of the optical fiber. According to some embodiments, the detector includes an encoder configured to measure the longitudinal position of the distal end of the optical fiber.

[0019] The system may further include a handle coupled to one or more of the generator and the elongated body, wherein the handle includes the encoder. In some embodiments, the system further includes a hub coupled to one or more of the generator and the elongated body, wherein the hub includes the encoder. According to some embodiments, the system further includes a sled coupled to one or more of the generator and the elongated body, wherein the sled includes the encoder.

[0020] The optical fiber may be rotatable with respect to a central longitudinal axis of the elongated body. In some embodiments, the aspect of the optical fiber is a rotational position of a distal end of the optical fiber. According to some embodiments, the detector includes an encoder configured to measure the rotational position of the distal end of the optical fiber.

[0021] The system may further include a handle coupled to one or more of the generator and the elongated body, wherein the handle includes the encoder. In some embodiments, the system further includes a hub coupled to one or more of the generator and the elongated body, wherein the hub includes the encoder. According to some embodiments, the system further includes a sled coupled to one or more of the generator and the elongated body, wherein the sled includes the encoder.

[0022] The optical fiber may be deflectable with respect to a central longitudinal axis of the elongated body. In some embodiments, the aspect of the optical fiber is an angle of deflection of a distal end of the optical fiber. According to some embodiments, the detector includes a rotational encoder configured to measure the angle of deflection of the distal end of the optical fiber.

[0023] The system may further include a handle coupled to one or more of the generator and the elongated body, wherein the handle includes the rotational encoder. In some embodiments, the system further includes a hub coupled to one or more of the generator and the elongated body, wherein the hub includes the rotational encoder. According to some embodiments, the system further includes a sled coupled to one or more of the generator and the elongated body, wherein the sled includes the rotational encoder.PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCT

[0024] The system may further include a marker band located on the distal end of the optical fiber or adjacent the distal end of the optical fiber. In some embodiments, the detector includes a fluoroscopic device configured to measure i) the longitudinal position of the distal end of the optical fiber, ii) the rotational position of the distal end of the optical fiber, iii) the angle of deflection of the distal end of the optical fiber, or iv) any combination thereof, using the marker band.

[0025] According to some embodiments, the aspect of the laser energy is a pulse energy. The detector may include a photodetector configured to receive the laser energy and output a signal, the signal indicative of the pulse energy. In some embodiments, the detector further includes a pyroelectric detector configured to measure the pulse energy. According to some embodiments, the pyroelectric detector is configured to measure a temperature increase corresponding to a change in the pulse energy of the laser energy. The temperature increase may be a transient temperature increase.

[0026] The aspect of the laser energy may be a peak power. In some embodiments, the peak power is measured through obtaining a pulse energy and a pulse width, the peak power being measured by dividing the pulse energy by the pulse width. According to some embodiments, the detector is configured to measure the pulse energy, the pulse width, or both, of the laser energy.

[0027] Also included in the present disclosure is a system, including an elongated body having a guidewire lumen. In some embodiments, the system includes a pressure wave emitter disposed about the elongated body and having an optical fiber configured to transmit laser energy into a fluid to create plasma, a cavitation bubble, or both in the fluid, such that the laser energy is configured to enable a pressure wave to be generated. According to some embodiments, the system includes a generator coupled with the pressure wave emitter. The system may include a power supply coupled to the generator and configured to supply electrical power to the generator. In some embodiments, the system includes a detector configured to detect an aspect of the power supply, the electrical power supplied by the power supply, or the generator.

[0028] According to some embodiments, the elongated body includes an inner elongated structure, the inner elongated structure including the guidewire lumen. The pressure wave emitter may be positioned along a central longitudinal axis of the elongated body. In some embodiments, the aspect of the electrical power is a voltage. According to some embodiments, the detector includes a voltmeter configured to measure the voltage.PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCT

[0029] Also included in the present disclosure is a system, including an elongated body having a guidewire lumen. In some embodiments, the system includes a balloon positioned at a first end of the elongated body, the balloon configured to receive an inflation fluid to inflate the balloon. According to some embodiments, the system includes an inflation lumen extending from a second end of the elongated body into the balloon, thereby forming a fluid pathway. The system may include a pressure wave emitter disposed about the elongated body and having an optical fiber configured to transmit laser energy into the inflation fluid to create plasma, a cavitation bubble, or both, in the inflation fluid, such that the laser energy is configured to enable a pressure wave to be generated. In some embodiments, the system includes a detector configured to detect an aspect of the inflation fluid along the fluid pathway or an aspect of the balloon.

[0030] According to some embodiments, the elongated body includes an inner elongated structure, the inner elongated structure including the guidewire lumen. The pressure wave emitter may be positioned along a central longitudinal axis of the elongated body. In some embodiments, the aspect of the balloon is a balloon pressure. According to some embodiments, the detector includes a pressure sensor configured to measure the balloon pressure. The pressure sensor may be located along the fluid pathway.

[0031] In some embodiments, the system further includes a handle located along the fluid pathway, the handle coupled to one or more of the generator and the elongated body, wherein the pressure sensor is disposed on or about the handle. According to some embodiments, the system further includes a hub located along the fluid pathway, the hub coupled to one or more of the generator and the elongated body, wherein the pressure sensor is disposed on or about the hub. The system may further include a sled located along the fluid pathway, the sled coupled to one or more of the generator and the elongated body, wherein the pressure sensor is disposed on or about the sled.

[0032] In some embodiments, the detector is configured to detect an external temperature or a temperature relating to the system. According to some embodiments, the external temperature is indicative of an ambient temperature. The detector may include a thermocouple, a resistance temperature detector (RTD), at thermistor, or any combination thereof, each configured to measure the external temperature. In some embodiments, the detector includes the thermocouple, the thermocouple being disposed on an interior surface of the balloon, on an exterior surface of the balloon, or within the balloon.

[0033] According to some embodiments, the aspect of the inflation fluid is a temperature of the inflation fluid. The detector may include an infrared sensor configured to measure thePCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTtemperature of the inflation fluid, corresponding to the external temperature. In some embodiments, the balloon includes the infrared sensor.

[0034] According to some embodiments, the detector includes an infrared sensor configured to measure the temperature of the inflation lumen. A refractive index may be measured, the refractive index indicative of the temperature of the inflation fluid. In some embodiments, the refractive index is measured as a direct current (DC) output.

[0035] According to some embodiments, the system further includes an optical fiber connector configured to couple the optical fiber to the generator. The detector may be configured to detect a temperature of the optical fiber connector. In some embodiments, the detector includes a thermocouple, a resistance temperature detector (RTD), a thermistor, or any combination thereof, each configured to measure the temperature of the optical fiber connector. According to some embodiments, the detector includes the thermocouple, thermocouple being located on an interior surface of the balloon, on an exterior surface of the balloon, or within the balloon. The detector may include an infrared sensor configured to measure the temperature of the optical fiber connector.

[0036] Also included in the present disclosure is a system, including an elongated body having a guidewire lumen. In some embodiments, the system includes a pressure wave emitter disposed about the elongated body and having an optical fiber configured to transmit laser energy into a fluid to create plasma, a cavitation bubble, or both, in the fluid, such that the laser energy is configured to enable a pressure wave to be generated. According to some embodiments, the system includes a generator coupled with the pressure wave emitter. The generator may include a coolant flow pathway configured to deliver coolant to one or more components of the generator. In some embodiments, the system includes a detector configured to detect an aspect of the coolant or the coolant flow pathway.

[0037] According to some embodiments, the elongated body includes an inner elongated structure, the inner elongated structure including the guidewire lumen. The pressure wave emitter may be positioned along a central longitudinal axis of the elongated body.

[0038] In some embodiments, the aspect of the coolant is a flow rate of the coolant. According to some embodiments, the detector includes a flow meter configured to measure the flow rate of the coolant. The flow meter may be configured to spin in response to a coolant flow and thereby convert a rotation to an electrical current. In some embodiments, the system further includes a hose pipe located along the coolant flow pathway, wherein the flow meter is located in line with the hose pipe.PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCT

[0039] According to some embodiments, the detector includes an ultrasonic device configured to measure the flow rate of the coolant. The ultrasonic device may include a hydrophone. In some embodiments, the detector includes a calorimeter configured to measure the flow rate of the coolant.

[0040] According to some embodiments, the aspect of the coolant is a conductivity of the coolant. The detector may include a conductivity sensor configured to measure the conductivity of the coolant. In some embodiments, the conductivity sensor is located along the coolant flow pathway.

[0041] According to some embodiments, the aspect of the coolant is a temperature of the coolant. The detector may include a thermocouple configured to measure the temperature of the coolant. In some embodiments, the thermocouple is located along the coolant flow pathway.

[0042] According to some embodiments, the aspect of the coolant is a pressure of the coolant. The detector may include a pressure sensor configured to measure the pressure of the coolant. In some embodiments, the pressure sensor is located along the coolant flow pathway.

[0043] According to some embodiments, the detector is in communication with a processor configured to output a respective detection by the detector. The output may include a visual output depicted on a display that is in communication with the processor, an audio output, a communication sent to an interested party, an automatic shutdown of one or more components of the system, or any combination thereof.

[0044] In some embodiments, the system further includes a connector located along the optical fiber pathway proximal to the pressure wave emitter. According to some embodiments, the connector is i) a subminiature version A (SMA) connector, ii) a ferrule connector (FC), iii) a subscriber connector (SC), iv) a straight tip (ST) connector, v) an FC angled physical contact (FC-APC) connector, or vi) an SC physical contact (SC-PC) connector. The connector may have an angled face from about 0.5 degrees to about 15 degrees.

[0045] In some embodiments, the system further includes a position sensitive detector configured to detect a position of returning laser energy with respect to a nominal position. According to some embodiments, the system further includes a polarization diversity detector configured to detect an overall intensity of laser energy via a polarization of outgoing laser energy and returning laser energy.PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTBRIEF DESCRIPTION OF THE DRAWINGS

[0046] These and other features, aspects, and advantages are described below with reference to the drawings, which are intended to illustrate, but not to limit, the invention. In the drawings, like characters denote corresponding features consistently throughout similar embodiments.

[0047] FIG. 1 illustrates a diagrammatic view of an intravascular lithotripsy (IVL) system as it may appear inserted into a patient’s vasculature, according to some embodiments.

[0048] FIG. 2 illustrates a perspective view of an IVL balloon, along with an inset view illustrating a position for the distal fiber end of an optical fiber according to an IVL catheter, according to some embodiments.

[0049] FIG. 3 illustrates an IVL system, according to some embodiments.

[0050] FIG. 4 illustrates an exemplary block flow diagram of the electrical, fluid, and optical pathways of the IVL system, according to some embodiments.

[0051] FIG. 5 illustrates a block diagram of the laser energy source system, such as the control and operational aspects, according to some embodiments.

[0052] FIG. 6 illustrates an exemplary block diagram of components within a generator, according to some embodiments.

[0053] FIG. 7 illustrates another exemplary block diagram of components within the generator, according to some embodiments.

[0054] FIGS. 8A-8E illustrate exemplary block diagrams of the components from FIG. 7, according to some embodiments.

[0055] FIGS. 9A-9B illustrate exemplary block diagrams of the laser generator and a testing diode, according to some embodiments.

[0056] FIG. 10 illustrates an exemplary block diagram of components within a generator leading toward an optical fiber with additional detection features, according to some embodiments.

[0057] FIG. 11 illustrates a subminiature version A (SMA) connector optically coupled to an optical fiber, according to some embodiments.

[0058] FIG. 12 illustrates another exemplary block diagram of components within a generator leading toward an optical fiber with additional detection features, according to some embodiments.

[0059] FIG. 13 illustrates an exemplary block diagram of the detector system, according to some embodiments.

[0060] FIG. 14 illustrates an exemplary block diagram of generator related aspects detected by the detector system, according to some embodiments.PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCT

[0061] FIG. 15 illustrates an exemplary block diagram of optical fiber related aspects detected by the detector system, according to some embodiments.

[0062] FIG. 16 illustrates an exemplary block diagram of injection fluid and / or balloon related aspects detected by the detector system, according to some embodiments.

[0063] FIG. 17 illustrates an exemplary block diagram of electrical related aspects detected by the detector system, according to some embodiments.

[0064] FIG. 18 illustrates an exemplary block diagram of coolant related aspects detected by the detector system, according to some embodiments.DETAILED DESCRIPTION

[0065] During an intravascular lithotripsy (IVL) procedure, a clinician may use a catheter that enables breaking apart calcified-plaque lesions within a patient’s vasculature. Some such methods for breaking apart the lesions include the creation and rapid collapse of cavitation bubbles to create a shock wave, which causes this calcification break-up. In additional or alternative embodiments, some such methods include creating a plasma, wherein the sudden expansion and compression creates a shock wave, which causes the calcification break-up. Additionally or alternatively, shock waves may be created as a result of stress-confinement imposed within the bubble.

[0066] Although specific examples are disclosed below, inventive subject matter extends beyond the specifically disclosed examples to alternative examples and / or uses and modifications and equivalents thereof. Thus, the scope of the claims appended hereto is not limited by any of the particular examples described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations, in turn, in a manner that may be helpful in understanding specific examples; however, the order of description should not be construed to imply that these operations are order-dependent. Additionally, the structures, systems, and / or devices described herein may be embodied as integrated or separate components.

[0067] For purposes of comparing various examples, certain aspects and advantages of these examples are described. Not necessarily all such aspects or advantages are achieved by any particular example. Thus, for example, various examples may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCT

[0068] During an intravascular lithotripsy (IVL) procedure, a clinician uses the formation and subsequent collapse of cavitation bubbles (and / or creation of plasma, and / or by stress-confined heating of a volume of saline) to generate high-energy pressure waves to disrupt calcified-plaque lesions within a patient’s vasculature. The pressure waves may be shock waves. Some such IVL procedures include the generation of shock waves through the providing of laser energy, such as via an optical fiber. The laser energy may be emitted within fluid contained by a balloon, as described herein.

[0069] FIG. 1 illustrates a diagrammatic view of an intravascular lithotripsy (IVL) system 10 as it may appear inserted into a patient’ s vasculature. The IVL system 10 may include a medical device 12, perhaps including an interventional balloon, as depicted in later figures. During a lesion-disintegration procedure, a clinician may advance the medical device 12 through an access point 14 in the patient 20, such as the femoral or common femoral arteries, as depicted in FIG. 1. Other access points may include the radial artery, tibial artery, pedal artery, axial artery, peroneal artery, etc. The medical device 12 may then be advanced through the vasculature of the patient 20 until it reaches the vessel 30 containing the treatment area 40. For IVL, the treatment area may include a calcified lesion 50.

[0070] FIG. 2 illustrates a perspective view of the medical device 12, disposed within an elongated body 202 (as described herein), wherein the medical device 12 includes a fluid-inflatable interventional balloon 102. FIG. 2 further includes an inset view illustrating a position for the distal fiber end of an optical fiber 210. In this example, and the examples following, any present optical fibers 210 act as pressure wave emitters 204. According to the example of FIG. 2, a protective sleeve may contain the inner shaft and / or any present lumens and protect these surfaces from any energy emissions from a distal fiber end of the optical fibers 210. While not shown in the figures, the optical fiber 210 may include a rounded or blunt feature on its terminal portion to prevent accidental perforation of the balloon 208 by the optical fiber 210. It is understood that such a toe or blunt feature would not impede the passage of laser energy from the distal fiber end.

[0071] The balloon 208 may be in fluidic communication with a fluid pathway, configured to receive an inflation fluid, so that the balloon may expand.

[0072] FIG. 3 is a diagram illustrating an IVL system 10. As shown in FIG. 3, IVL system 10 may include at least a generator 304 and the elongated body 202 removably coupled to the energy generator 304, such as via an optical connector 306. As described herein, the generator 304 may be configured to generate the laser energy delivered to the elongated body 202 (e.g., optical fibers within the elongated tube). The elongated body 202 may include a medical devicePCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCT12 positioned at a distal portion of the elongated body (e.g., distal elongated body portion 206). In some examples, the elongated body 202 is configured to navigate a tortuous vasculature of a patient 20 toward a target treatment site 40, e.g., a calcified-plaque lesion 50 within a vessel 30. As used throughout the present disclosure, the term generator is used synonymously with a laser console or any other device capable of providing laser energy to any present optical fiber.

[0073] Additionally, while the connector 306 is described as an optical connector 306 in the description of FIG. 3, it is understood that the connector 306 may also be an electrical connector. In fact, in some examples, the IVL system 10 may not necessitate an electrical connector. In these examples, a therapy button may be present on the console, and there may be no electrical interrogation of the catheter itself. While an electrical connector may not be necessary in all examples, an optical connector 306 is necessary in order to provide the laser energy to the catheter (e.g., elongated body 202).

[0074] As shown in FIG. 3, the medical device 12 may include the fluid-inflatable interventional balloon 102 and the pressure wave emitter array, shown but not labeled due to size constraints, positioned within the balloon 102. The emitter array may include one or more individual emitter units. For instance, the interventional balloon 102, or a distal elongated body portion 206 passing therethrough, may define a central longitudinal axis 314, and emitter units may be distributed longitudinally along the central longitudinal axis 314.

[0075] Each emitter unit is configured to receive the laser energy from the generator 304 and use the received energy to generate and transmit high-energy pressure waves through the balloon 208 (e.g., via the inflation fluid within the balloon) and across a treatment site. As detailed further below, the generator 304 may generate and transmit energy in the form of electrical energy, optical energy, or a combination thereof. For instance, the emitter unit(s) may use the received energy to generate plasma, a cavitation bubble, or both, within the fluid inside the balloon 208, thereby enabling the propagation of one or more high-energy pressure waves radially outward through the balloon 208, and or in a forward direction out of the balloon 208, and towards the calcified lesion 50.

[0076] In some cases, but not all cases, a secondary set of high-energy pressure waves can subsequently result from the collapse of the fluid cavitation bubble, compression of the plasma, or both, further destabilizing the internal structure of the calcified-plaque lesion. In some examples, one or more emitters can include an optical-based emitter configured to receive a high-energy optical (e.g., light, laser energy, etc.) signal from the generator 304, such as via one or more optical fibers, and direct the optical signal to trigger the initial cavitation, plasmaPCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTgeneration, or both, within the fluid that is disposed within the balloon (for example). Additionally, or alternatively, one or more emitters can include an electrical-based emitter configured to receive electrical energy from the generator 304, such as via one or more conductive wires, and generate a spark between a pair of electrodes, thereby triggering the initial cavitation (and / or plasma generation).

[0077] According to some examples, a cooling mechanism functions in tandem with the generator 304. Flashlamp systems may provide energy to the optical fibers with or without necessitating said cooling mechanism. Additionally, diode systems may be used as an alternative to flashlamp systems, which may also not require a cooling mechanism.

[0078] A medical post may be provided to facilitate movement of the IVL system 10 between rooms as necessary. The IVL system may include a power supply 302 separate from the generator 304. The power supply 302 may be situated near the base of the medical post. The power supply may be configured to receive electrical power using a power cord 308 for receiving wall power, as well as an umbilicus for electrically coupling to a console. Alternatively or additionally, the power supply may include one or more batteries (and / or an uninterruptible power supply) to supply power to the generator 304. As shown in FIG. 3, the generator 304 allows a user, such as a clinician, to operate the IVL system 10. The elongated body 202 may be coupled to the generator 304 via a power cable for receiving electrical power from the power supply 302 to generate and transmit laser energy to the emitters within the IVL balloon 102. A separate line dedicated for delivering fluid and / or inflating the IVL balloon 208 may also be present.

[0079] The IVL system 10 disclosed herein may include any component and any operational method as described in U.S. patent application 18 / 595,031 and U.S. provisional application 63 / 618,763, each of which the entirety is incorporated herein by reference.

[0080] FIG. 4 illustrates an exemplary block diagram of the electrical pathway 402, the optical pathway 404, and the fluid pathway 406 of the IVL system 10. An optional coolant flow pathway 408 is also illustrated, which may be part of the generator 304. The electrical pathway 402 may include the power supply 302 supplying power to the generator 304 for generating the laser energy. The generator 304 may also be configured to provide power to an actuator 410 configured to cause the generator 304 to generate and deliver laser energy. For example, the actuator 410 may be in communication with the hub 214, and be configured to initiate one or both of i) the laser generation and delivery (e.g., from the generator 304) of laser energy via an optical pathway 404, and ii) the inflation of the balloon 208 by initiating a syringe 416 to introduce inflation fluid to the hub 214 via a fluid pathway 406. The actuator 410 may includePCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTa handle 412 and / or a sled 414 configured to initiate, stop, pause, and / or resume delivery of the inflation fluid and / or laser energy. As described herein, the medical device 12 is in communication with the optical pathway 404 and / or fluid pathway 406 to receive the laser energy and / or inflation fluid respectively.

[0081] Stated another way, the IVL system 10 may include an electrical pathway 402 originating at the power supply 302. The power supply 302 may provide electricity to the generator 304, which in turn traverses to a hub 214. The electrical pathway 402 may also branch from the generator 304 to an actuator 410, which may include a handle 412 and / or a sled 414, before leading back to / through the hub 214. In this way, an operator may control the flow of electricity to the hub 214 external from the generator 304. The generator 304 may include coolant for cooling portions of the generator, including a laser source system as described below, and thus a coolant flow pathway 408 as well.

[0082] The IVL system 10 may further include an optical pathway 404 originating from the generator 304, such as through a laser source system, which extends through the hub 214 and terminates at the medical device 12. The medical device 12 may include a balloon 208, and in some embodiments, the optical pathway 404 terminates within the balloon 208. The IVL system 10 may also include a fluid pathway 406, extending through the hub 214 and to the balloon 208 to inflate the balloon 208, as well as provide a medium for the laser energy through the optical pathway 404 to create cavitation bubbles. One manner of providing fluid through the fluid pathway 406 is via a syringe 416, and in some embodiments, the fluid pathway 406 originates at this syringe 416.

[0083] FIG. 5 illustrates an exemplary block diagram of the laser energy source system 502, according to some examples. As can be seen by the dotted line surrounding a majority of the components, the laser energy source system 502 includes an energy source. Power, such as power from a wall, as shown by the arrow leading through the 120 V (IN), may be provided to the power supply 302 within the energy source. The power supply 302 provides power to a flashlamp power supply 504 and a central processing unit (CPU) 518. The flashlamp power supply 504 may be controlled by the CPU 518.

[0084] The CPU 518 includes a user interface, which may involve tactile buttons and switches or other means of user communication, such as a touch screen. A power on switch 516 is shown in electronic communication with the CPU 518, as well as push buttons 520 for resetting the CPU 518 (reset) and initiating the treatment once the elongated body 202 is in place (therapy). The CPU 518 also controls the lamps 514 (On, RDY (Ready), E (Emission), and F (Fault)). The on lamp 514 indicates that the laser energy source system 502 is turned on. The RDY lampPCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCT514 indicates that the laser energy source system 502 is connected and ready to actuate 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 laser energy source system 502 needs to be reset. In IVL systems 10, including safety features such as a safety pressure sensor 522 as described above, the CPU 518 receives this feedback from the pressure sensor 522, which, as it is located in the IVL balloon 102, exists outside of the energy source.

[0085] The flashlamp power supply 504 includes lamp leads 506 that electrically couple the flashlamp power supply 504 to a laser head 508. The laser head 508 is aimed at a shutter 510, which is in electronic communication with and controlled by the CPU 518. The shutter 510 is an additional safety to prevent premature emission of the laser through the elongated body 202. The shutter 510 is commanded by the CPU 518 just prior to triggering the flashlamp, 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 and not a flashlamp. The shutter 510 separates the laser head 508 from the optical fibers, as indicated by the fiber out 512. The optical fibers then travel the length of the elongated body 202 to the treatment site. In IVL systems 10, including safety features such as a fiber interrogation mechanism 524 described herein, the CPU 518 receives feedback from the optical fiber through the fiber interrogation mechanism 524, as shown. Because the fiber interrogation mechanism 524 may operate from anywhere along the fiber line (a break anywhere in the line can be detected anywhere else along the line, as long as the detection is occurring prior to the break), the fiber interrogation mechanism 524 is shown as being conveniently located within the energy source.

[0086] FIG. 6 illustrates certain components for an exemplary laser generator 600 (e.g., see generator 304 from FIG. 3) configured to generate and deliver laser energy to one or more pressure wave emitters, so as to create a plasma, a cavitation bubble, or both within a fluid, and thereby enable a pressure wave to be generated, as described herein. The exemplary components illustrated for the generator 600 define at least a portion of an optical pathway for the laser energy prior to entering the optical fiber 210 for delivery to the distal portion of the elongated tube (as described herein). The generator 600 may include a rod 606 configured to act as a gain medium, thereby generating the laser energy (e.g., via a pump source, such as a flash lamp, or an electrical current). The generator 600 may include a high reflector 602 and an output coupler 608, between which the laser energy generated via the rod 606 is configured to reflect back and forth to help achieve gain or amplification in the laser energy. One or more pinholes 604 may be disposed between the rod 606 and the high reflector 602, and / or between the rod 606 and the output coupler 608, wherein each pinhole 604 may be configured to act asPCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTa mode volume restricting element to change the beam quality of the laser, or as alignment aids (e.g., during manufacturing) and / or during any servicing.

[0087] The output coupler 608 may be a partial reflector, configured to pass only a certain portion of the laser energy therethrough (while at least some of the remaining laser energy is reflected back towards the rod 606). The laser energy that passes through the output coupler 608 may then be directed through the optical pathway to an optical fiber 210. The laser energy may be directed using one or more reflectors, each of which may have high reflectivity and / or be a partial reflector. The optical pathway may include collimating lens 610 to help make the laser energy parallel (e.g., the laser beam rays) and minimize or eliminate divergence of the laser energy as it travels through the optical pathway and / or through the optical fiber 210. The optical pathway may also include a partial reflector 614 configured to reflect at least a portion of the laser energy towards a power meter 616, configured to detect an amount of laser energy power in the optical pathway (as described herein, see FIG. 8D for example). The optical pathway may further include one or more numerical aperture limiting pinholes 618, which may be configured to protect the delivery fiber against the launch of laser energy at inappropriately large angles of incidence.

[0088] The generator 600 may further include an alignment laser 612 configured to help align the laser energy along the optical pathway. The alignment laser 612 may be used with one or more reflectors (e.g., a reflective mirror), any of which may be a partial reflector. The alignment laser 612 may also be configured to indicate to a user that the IVL system (as described herein) is in operation and / or operational. For example, if the fiber on the catheter is fractured by inappropriate handling, the break point may glow through the catheter wall where the visible laser impinges on the break and is no longer optically guided by the fiber.

[0089] FIGS. 7-8E illustrates an example of the components of another generator 700, as described herein. The generator 700 may include a laser resonator laser cavity 702 configured to generate the laser energy, a Galilean telescope 704 configured to operate as a beam expander, one or more safety features 706 configured to act as a safeguard for the patient, user, generator and / or IVL system from any faults therein, a fiber focus assembly 708 configured direct the laser energy from the optical pathway in the generator 700 to the optical fiber 210, an alignment laser 714 configured to align the laser energy along the optical pathway 718, one or more mirrors 710 configured to at least partially reflect the laser energy, one or more pinholes 712 configured to act as alignment aids for both manufacturing and field service purposes, or any combination thereof.PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCT

[0090] As described herein, an optical pathway 718 may be defined from within the laser resonator laser cavity 702, through which the laser energy travels, and the optical pathway may extend from the laser resonator laser cavity 702 to the relay mirror 710, through the Galilean telescope 704, the relay mirror 710, through the pinholes 712, through the safety features 706, and through at least a portion of the fiber focus assembly 708.

[0091] Any one or more of the components of the generator 700 may be disposed within a housing, such as depicted for generator 304 in FIG. 3.

[0092] FIG. 8A illustrates an exemplary embodiment of the laser resonator cavity 702, which may include a high reflector 802, a Q-switch module 804, one or more quarter-wave plates 806 configured to suppress spatial hole burning which may round out the mode in the rod, which is better for fiber face survivability and may provide more energy, a rod 808, an output coupler 810, or any combination thereof. Similar to as described for the generator 304 in FIG. 6, the rod 808 may be configured to act as a gain medium, thereby generating the laser energy (e.g., via an optical pump source, such as a flash lamp, one or more diode lasers, a fiber laser, or an electrical pump source, such as diode lasers or vertical cavity surface emitting lasers), wherein the generated laser energy may be reflected between the high reflector 802 (which may be similar to high reflector 602) and the output coupler 810 (which may be similar to output coupler 608), to help achieve gain or amplification in the laser energy. In some embodiments, the laser resonator laser cavity 702 includes a Q-switch module 804 configured to enable the laser energy to be generated in a pulsed output configuration. FIG. 8B depicts an exemplary embodiment of the Q-switch module 804, which may include a quarter-wave plate 806, one or more Pockels cells 812, a polarizer 814, or any combination thereof. The quarter-wave plate 806 may be configured to alter a polarization state of a light wave (e.g., light energy) traveling therethrough. The laser resonator laser cavity 702 may also include a quarter-wave plate (see FIG. 8A for example). The laser resonator laser cavity 702, or at least a portion thereof, may be referred to as the laser head. In other embodiments, an Acousto-optic modulator may be used instead of a Q-switch, wherein a quarter-wave plate may then not be needed inside the Q-switch module. The quarter-wave plates for spatial hole burning suppression may work with either an acousto-optic (AO) or electro-optic (EO) Q-switch.

[0093] FIG. 8C depicts the Galilean telescope 704 including a concave telescope lens 816 and a convex telescope lens 820, either of which may be substituted or removed. An all-reflective telescope may be constructed using sequential convex and concave high-reflector mirrors to achieve a larger (collimated) beam. FIG. 8D depicts the safety features 706, which may include a wedged beam splitter 822, a main photodetector 824, a safety photodetector 826, a safetyPCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTshutter 828, and a dichroic reflector 830. The wedged beam splitter 822 may act as a partial reflector, so as to reflect some of the laser energy in the optical pathway 718 to the main photodetector 824, which may act as a power meter, and may be configured to measure an optical power of the light energy. The wedge may ensure that the two Fresnel reflections (beams) from each of the two surfaces diverge, thereby ensuring that only one source of energy impinges on the detector, and that no confounding interference effects between the two beams adversely affect the ability of the sensor to accurately monitor the power to the patient. As described herein, the main photodetector 824, may be configured as a detector for a fault in the laser energy and / or in the optical pathway. The safety features 706 may further include a safety photodetector 826, configured to act as a safeguard and prevent operation of the IVL system if the same laser energy is not detected on both cells simultaneously. The main photodetector 824 and safety photodetector 826 may provide a redundant means of protection, such that the failure of one photodetector would not compromise the safeguard provided by the second photodetector. A single photocell may fail in a way that might appear as normal operation to the CPU, but the chances of both cells failing in the same manner simultaneously are vastly reduced.

[0094] The safety features 706 may further include a safety shutter 828 configured to prevent the laser energy from being transmitted to the fiber focus assembly. The safety shutter 828 may be similar to shutter 510 described herein, which acts as an additional safety to prevent premature emission of the laser through the elongated body. The safety shutter 828 may also be configured to receive a command to shut, or may be in communication with another device, either directly or indirectly. For example, the safety shutter may be in communication with the safety photodetector 826, such that if no or incorrect laser energy is directed at the safety photodetector 826, the safety shutter will automatically shut and prevent or substantially prevent light to be transmitted therethrough. The safety shutter may be positioned such that the laser module can emit energy, which is measured by the photocells, but where the launch of energy into the therapeutic fiber is stopped by the shutter. This may permit the laser to safely self-test and self-calibrate without emission of radiation that might harm the patient and any present operators.

[0095] The safety features 706 may further include one or more dichroic reflectors 830 configured to pass the laser energy (generated from the laser resonator laser cavity 702) and / or reflect laser energy received from the alignment laser 714 (that may be reflected via the alignment mirror 716), such that laser energy from either source is directed towards the fiber focus assembly 708.PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCT

[0096] FIG. 8E illustrates an exemplary embodiment of the fiber focus assembly 708, which may include one or more numerical aperture limiting pinholes 832, a fiber focus lens 836, and / or a blast shield 834, and wherein the optical pathway 718 in the generator 700 couples with the optical fiber 210. The fiber focus lens 836 may help focus the received laser energy down to be delivered through the fiber. The blast shield may provide at least some protection for the components in the generator 700 from a laser blast, which may result from a failure in the optical fiber 210. The blast shield may include a position sensor (as described herein). The fiber focus assembly 708 may further include a photodiode to monitor any scattered laser energy to correlate with fiber interrogation, for example.

[0097] FIG. 9A illustrates an embodiment where a testing laser diode 902 is used to confirm alignment and operational integrity of the optical pathway, within the generator 700 and / or the optical fiber. The testing laser diode 902 may emit a laser with a distinct identifier, e.g., a red light (e.g., via a red diode), wherein a reflection as measured using a photodiode 906 may be used to check the integrity for laser emitted through the generator and / or optical fiber. The laser energy from the testing laser diode 902 may be different from the therapeutic laser beam 918, wherein the therapeutic laser beam may be generated for example via the laser resonator laser cavity (as described herein).

[0098] The outgoing laser energy from the testing laser diode 902 may be split into 2 beams via a 50:50 beam splitter 908, where half of the laser energy from the testing laser diode 902 goes to the main optical pathway (e.g., 718), optionally via a reflector 910, while the other half of the laser energy from the testing laser diode 902 goes to a low-return loss termination to eliminate or reduce back-reflection that may swamp the rest of the signal.

[0099] With continued reference to FIG. 9A, the laser energy from the testing laser diode 902 may go to the distal tip of the optical fiber to help indicate an operational generator and / or optical fiber. In some embodiments, there will be some back-reflections from all the intermediate elements (e.g., fiber focus lens, fiber launch face, distal tip, etc.), wherein such back-reflections may be constant. In some embodiments, the reflections all add up and go back to the beam splitter 908 where half is sent to the photodiode 906, and half goes back into the testing laser diode 902. The photodiode 906 monitors the intensity of all the reflections, so if there are variations along the optical pathway and / or optical fiber of the laser energy from the testing laser diode, this intensity may also change, which may correlate to a fault in the generator and / or optical fiber.

[0100] In some embodiments, if the fiber face detonates (or, stated another way, catastrophic optical damage may cause material to be ejected from the fiber face (e.g., spallation), and thisPCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTejecta may be or may approximately be Lambertian, which is a cosine dependence in angle from normal from the surface) the blast shield may prevent the debris from coating the lens which may trigger a service call or an increase in signal from scattering. A second photodiode 916 in the fiber focus assembly 912 is illustrated and configured to monitor the laser energy within the fiber focus assembly 912, which may generally be constant except possibly for when the lamps (for producing the therapeutic laser energy, for example) fire and / or due to a fault. If the fiber breaks in the device, the photodiode 916 may detect a change in the laser energy. In some cases, a break in the optical fiber may result in a Fresnel reflection (e.g., around 3 - 4.5% of the forward energy) to add to the total (of the laser energy detected by the second photodiode 916). This may also occur if a bubble settles on the end of the fiber if and / or when the inflation fluid (e.g., saline) outgasses when heated.

[0101] In some embodiments, the photodiode 906 and photodiode 916 may be used with reference to each other to help identify a potential location for a fault. For example, if the signal for only the photodiode 906 rises or changes compared to the photodiode 916 in the fiber focus assembly 912, this may suggest a fault in the optical fiber (e.g., within the catheter). If however, the signal for both the photodiode 906 and photodiode 916 rise or change, this may suggest a fault in the fiber focus assembly 912 itself.

[0102] FIG. 9B depicts another embodiment of the testing laser diode 902 system and laser energy delivery, where the difference from the system FIG. 9A is the auto balancing receiver 920 and reflector 922 depicted. Here, the auto balancing receiver 920 may take the unused 50% of the energy from the beam splitter (shown going to the low return-loss termination 904 in FIG. 9A) and uses it (with attenuation) as a reference beam for both intensity and frequency noise for the laser energy from the testing diode that is reflected back (e.g., similar to laser energy reflected back in to photodiode 906 in FIG. 9A). Accordingly, a comparison between the laser energy from the testing laser diode (that does not go to the optical fiber), and the reflected laser diode (that goes to the optical fiber) can be made. The auto balancing receiver 920 may have two photodiodes, one for receiving the “unused” laser energy from FIG. 9A as a “reference” value, and one for receiving the reflected laser energy from the fiber focus assembly and delivery fiber - (i.e., “the signal”). There may be allowances for common mode noise rejection so the output from the auto balancing receiver 920 as detecting the two laser energy beams can vary (and it may for most red multi-mode diode lasers), but the receiver 920 will cancel out this noise up to the bandwidth of the cancelling circuit. For example, the ultrasound pulse created when the shock front is generated from the stress-confined laser pulse,PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTand the second pulse when the bubble collapses, may show up at RF frequencies homodyned on the DC signal. The noise reduction may help tease this out.

[0103] FIG. 10 illustrates an additional system including components of a generator leading to an optical fiber for laser output. Here, three optical pathways are illustrated. An incoming horizontally polarized therapeutic beam (hereafter “incoming optical pathway 1002”), an alignment pathway 1004, and a return pathway from the lens, blast shield, fiber face, and bulk fiber (hereafter “return optical pathway 1006”).

[0104] The incoming optical pathway 1002 illustrates the path that the beam takes from the source within the generator through to the optical fiber 1022. The incoming optical pathway 1002 first partially passes through and partially reflects from a wedged beam splitter 1008, such as a wedged anti -reflection (AR) coated beam splitter. The portion of light that is reflected from this first wedged beam splitter 1008 then partially passes through and partially reflects from a second wedged beam splitter 1030, such as a wedged uncoated beam splitter. The light reflected from the wedged beam splitter 1030 may reflect some of the laser energy toward a main photocell 1032 and a safety photocell 1034. The main photocell 1032 may act as a power meter, and may be configured to measure an optical power of the light energy. As described with respect to FIG. 8C above, the wedged beam splitter 1030 may ensure that the two Fresnel reflections (beams) from each of the two surfaces diverge, thereby ensuring that only one source of energy impinges on the photocell, and that no confounding interference effects between the two beams adversely affect the ability of the sensor to accurately monitor the power to the patient. The main photocell 1032 may be configured as a detector for a fault in the laser energy and / or in the optical pathway.

[0105] The safety photocell 1034 may be configured to act as a safeguard and prevent operation of the IVL system if the same laser energy is not detected on both the main photocell and the safety photocell simultaneously. The main photocell 1032 and safety photocell 1034 may provide a redundant means of protection, such that the failure of one photocell would not compromise the safeguard provided by the other photodetector. A single photocell may fail in a way that might appear as normal operation to the CPU, but the chances of both cells failing in the same manner simultaneously are vastly reduced.

[0106] The portion of laser energy in the incoming optical pathway 1002 that passes through the first wedged beam splitter 1008 may then progress toward a safety shutter 1010. Similar to the safety shutter 828 of FIG. 8C but reiterated here, the safety shutter 1010 may be configured to prevent the laser energy from being transmitted to the fiber focus assembly. The safety shutter 1010 may act as an additional safety to prevent premature emission of the laser throughPCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTthe elongated body. The safety shutter 1010 may also be configured to receive a command to shut, or may be in communication with another device, either directly or indirectly. For example, the safety shutter 1010 may be in communication with the safety photocell 1034, such that if no or incorrect laser energy is directed at and / or detected by the safety photocell 1034, the safety shutter 1010 will automatically shut and prevent or substantially prevent light to be transmitted therethrough. The safety shutter 1010 may be positioned such that the laser module can emit energy, which is measured by the main photocell 1032 and the safety photocell 1034, but where the launch of energy into the therapeutic fiber is stopped by the safety shutter 1010. This may permit the laser to safely self-test and self-calibrate without emission of radiation that might harm the patient and any present operators.

[0107] After the safety shutter 1010, the incoming optical pathway 1002 may pass through a quarter-wave plate 1012. As with the quarter-wave plate of FIG. 8B above, the quarter-wave plate 1012 may be configured to alter a polarization state of a light wave (e.g., light energy) traveling therethrough.

[0108] Next, the incoming optical pathway 1002 may pass through a dichroic mirror 1014, which is used in conjunction with visible light passing through the alignment pathway 1004 as described in further detail below.

[0109] Finally, the laser energy enters into a fiber focus assembly, including numerical aperture limiting pinhole 1016, a fiber focus lens 1018, and / or a blast shield 1020, before optically coupling with the optical fiber 1022. As with FIG. 8E above but discussed here with respect to the current embodiment, the fiber focus lens 1018 may help focus the received laser energy down to be delivered through the optical fiber 1022. The blast shield 1020 may provide at least some protection for the components in the generator from a laser blast, which may result from a failure in the optical fiber 1022. The blast shield 1020 may include a position sensor (as described herein).

[0110] A visible laser source 1026 may provide a visible source of light that reflects off of a reflector 1028 and subsequently reflects off of the dichroic mirror 1014, as shown by the alignment pathway 1004. The visible source of light as provided by the visible laser source 1026 may align with the laser energy traveling on the incoming optical pathway 1002, thereby facilitating the alignment of said laser energy into the optical fiber 1022.

[0111] When the laser energy reaches an end of the optical fiber 1022, it may reflect back along the optical fiber 1022, and back through the blast shield 1020 (if present), the fiber focus lens 1018, the numerical aperture limiting pinhole 1016, the dichroic mirror 1014, the quarter- wave plate 1012, and the safety shutter 1010, before returning to the first wedged beam splitter 1008,PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTas shown by the return optical pathway 1006. Here, the returning laser energy may reflect, at least partially, toward a position sensitive detector 1024. The position sensitive detector 1024 may include sensors, including one nominal sensor, as well as additional sensors for detecting the laser energy. The nominal sensor, when struck by the laser energy, may indicate that the optical pathway is intact, indicating that there is likely no break or other fault with the optical fiber, or the system as a whole. The additional sensors, when struck by the laser energy, may indicate that the returning laser energy is on an unintended pathway, and as such, there is some issue with the system, such as a break in the optical fiber. Return optical pathway 1006 is generalized in FIG. 10 until reaching the wedged beam splitter 1008, at which point the emphasis in the distinction between a nominal return optical pathway 1006a and an incorrect return optical pathway 1006b is shown. A more specific illustration of the return optical pathway 1006 is illustrated in FIG. 11 below.

[0112] In some embodiments, a subminiature version A (SMA) connector 1102, such as an SMA connector with an angle-polished ferrule, is placed along the optical pathway between the blast shield 1020 and the optical fiber 1022 in order to amplify any potential deviation in laser energy traveling along the return optical pathway 1006 versus the incoming optical pathway 1002. Such amplified deviation may be expressed in the reflected angle of light coming from the wedged beam splitter 1008 toward the position sensitive detector 1024.

[0113] In additional or alternative embodiments, instead of an SMA connector, a ferrule connector (FC), a subscriber connector (SC), a straight tip (ST) connector, an FC angled physical contact (FC-APC) connector, an SC physical contact (SC-PC) connector, or likewise may be implemented and angled per the needs of the device.

[0114] FIG. 11 illustrates this in greater detail, showing the light traveling toward the SMA connector 1102 along the incoming pathway 1002, as well as light traveling away from the SMA connector 1102 along a nominal return optical pathway 1006a, and an incorrect return optical pathway 1006b. The deviation between return optical pathway 1006a and return optical pathway 1006b is intentionally amplified for illustration purposes. In practice, it is likely that the nominal return optical pathway 1006a would be parallel / along the same pathway as incoming optical pathway 1002, and any angle of deviation from such a nominal return optical pathway 1006a would result in an incorrect return optical pathway 1006b, resulting in the laser energy being detected by an additional sensor (e.g., other than the nominal sensor) in the position sensitive detector 1024 that indicates that there is an issue with the system as a whole, or with the optical fiber 1022.PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCT

[0115] The angle on the face of the SMA connector 1102 may be about two degrees relative to a plane perpendicular to the incoming pathway 1002. In additional or alternative embodiments, the angle on the face of the SMA connector 1102 is from about 0.5 degrees to about 15 degrees to a plane perpendicular to the incoming pathway 1002. Smaller angles may not affect the optical coupling into the optical fiber 1022 in terms of the beam profile or divergence. However, in additional or alternative embodiments, the same effect may be accomplished with a zero-degree face angle SMA connector by simply slightly angling the entirety of the SMA connector itself. On the return optical pathway 1006, the magnitude of reflection may change further if there is any damage to the blast shield 1020 or the face of the optical fiber 1022, or to any present AR coating on the wedged beam splitter 1008. Additionally, if the optical fiber 1022 has a breakage, Fresnel reflection from such a break would be refracted from an angled SMA connector 1102. As such, a position sensitive detector 1024 may see three separate light sources - the reflection from the fiber face of the optical fiber 1022, on-axis component reflections, and the refracted beam from the bulk fiber (e.g., on the return optical pathway 1006).

[0116] Analyzing these ratiometrically may pin down failures within the system. A large increase in the Fresnel reflection magnitude, or blooming of the beam (meaning more sensors in the 1024 are activated) may indicate a damaged face. A roughly constant face reflection intensity, but an increase in the bulk refracted signal may indicate a break in the catheter. A transient increase in the bulk signal may indicate a bubble on the end of the optical fiber 1022 within the catheter. An increase in on-axis component intensity and a drop in Fresnel reflection may indicate a damaged lens coating or a crazed blast shield 1020.

[0117] FIG. 12 illustrates an additional system including components of a generator leading to an optical fiber for laser output. Here, the incoming optical pathway 1202 and the alignment pathway 1204 are the same, or nearly the same, as the incoming optical pathway 1002 and the alignment pathway 1004 as shown and described in FIG. 10 above. As such, the pathway will be detailed here, but it is understood that the manner in which the laser energy and the visible light interact with the components is similar or the same as described and detailed above.

[0118] With respect to the incoming optical pathway 1202, the laser energy passes through a wedged beam splitter 1208 (such as a wedged AR coated beam splitter), a safety shutter 1210, a quarter-wave plate 1212, and a dichroic mirror 1214 before entering a fiber focus assembly. Within the fiber focus assembly, the laser energy passes through a numerical aperture limiting pinhole 1216, a fiber focus lens 1218, and a blast shield 1220 (if present) before passing into an optical fiber 1222. While not labeled in FIG. 12, an SMA connector may be present betweenPCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTthe fiber focus lens 1218 (and blast shield 1220 if present) and the optical fiber 1222. This SMA connector may be the same SMA connector as detailed in FIG. 11 above, or a different SMA connector.

[0119] Along the incoming optical pathway 1202, when the laser energy hits the wedged beam splitter 1208, a portion of the energy may be reflected back, at an angle, towards another wedged beam splitter 1230 (such as a wedged uncoated beam splitter). The light reflected from the wedged beam splitter 1230 may reflect some of the laser energy toward a main photocell 1232 and a safety photocell 1234, the potential benefits of which are described above with respect to FIG. 10 and corresponding photocell (1032, 1034).

[0120] A visible laser source 1226 may provide a visible source of light that reflects off of a reflector 1228 and subsequently reflects off the dichroic mirror 1214, as shown by the alignment pathway 1204. The visible source of light as provided by the visible laser source 1226 may align with the laser energy traveling on the incoming optical pathway, thereby facilitating the alignment of said laser energy into the optical fiber 1222.

[0121] When the laser energy reaches an end of the optical fiber 1222, it may reflect back along the optical fiber 1222, and back through the blast shield 1220 (if present), the fiber focus lens 1218, the numerical aperture limiting pinhole 1216, the dichroic mirror 1214, the quarter- wave plate 1212, and the safety shutter 1210, before returning to the first wedged beam splitter 1008, as shown by the return optical pathway 1206. Here is the primary difference between the embodiment as shown in FIG. 10 and the present embodiment of FIG. 12 (though this is not to say these embodiments cannot be combined). Here (FIG. 12), the returning laser energy may reflect, at least partially, toward a polarization diversity sensor 1224.

[0122] When a plane (linearly) polarized beam traverses a quarter- wavepl ate and is converted to circularly polarized light, and is subsequently reflected back and traverses through the same quarter- wavepl ate, the beam is converted to linearly polarized light that is rotated in polarity ninety degrees with respect to the incoming light. This is called cross-polarized light. This means that the fiber face, lens, and bulk fiber returns may be separated using such polarization of the beam.

[0123] In operation, the Fresnel reflection from the fiber face (assuming a zero-degree SMA polish (e.g., planar face of the SMA is perpendicular to the incoming optical pathway of the beam)) may come back in the orthogonal polarization to the outgoing therapeutic beam, so a cross-polarized light coming from a power monitor pickoff may be searched for / detected by the polarization diversity sensor 1224. If this value increases suddenly, it may indicate a damaged fiber face. This may also be the case for the lens back-reflection - an increase inPCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTcross-polarized light may be indicative of a damaged lens or coating. Similarly, a damaged blast shield may be indicated via a decrease in the apparent magnitude of the fiber face reflection.

[0124] Stated another way, when laser energy passes through a wedged beam splitter while on both the outgoing and returning optical pathways, the beam becomes cross-polarized. Through directing this cross-polarized beam toward a polarization diversity sensor, one can compare the resultant ratio of cross-polarized light to polarized light that is returning from the optical fiber. This ratio can then be considered in light of an expected ratio to determine whether something has gone wrong with the system (as described in the preceding paragraph), creating either a lack of or a surplus of cross-polarized light.

[0125] Also, while in operation, a multimode optical fiber 1222 may scramble the relative polarization of incoming and returning light based on factors such as the length of the fiber, the number of bends, and / or the bend radii of all bends in the optical fiber when laser energy is sent through the optical fiber 1222. However, while the ratio between the “horizontally” and “vertically” polarized light (read as: orthogonally distinct polarized light) may move around as the catheter is manipulated by an operator, the sum of the two channels may remain approximately constant. However, if there is a break in the catheter, the intensity on both detectors (here, photocells 1236a and 1236b) will suddenly increase. Likewise, if the distal face of the optical fiber 1222 becomes damaged, the total return will also increase, but likely not to the same extent as would be indicated as a bulk break, because the distal face of the optical fiber 1222 would be situated in liquid, which may provide an effective index matching.

[0126] Detector System

[0127] As described herein, the IVL system 10 may include one or more detectors configured to detect for an aspect relating to the IVL system 10, wherein the aspect may be a fault, or other feedback relating to the IVL system performance 10. The detectors may correspond to one or more aspects relating to i) the generator, ii) the optical fiber, iii) the injection fluid and / or balloon, iv) the power supply and / or a component along the electrical pathway, v) coolant and / or coolant pathway, or vi) any combination thereof.

[0128] FIG. 13 illustrates an exemplary block diagram of a detector system 1301, depicting communicative coupling between detectors for various components of the IVL system 10, and a processor 1302. In some embodiments, each detector is communicatively coupled with a processor 1302, such that the processor 1302 receives a communication if a given aspect is detected. In other embodiments, each detector may couple to a respective individual processor, or two or more of the detectors may be coupled to a common processor. For simplicity, FIG.PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCT13 illustrates a single communication line between the processor and a detector from a given source (e.g., generator, optical fiber, etc.), but each source may include multiple detectors, each of which may have a dedicated communication coupling with the processor 1302.

[0129] The processor 1302 may be configured to output 1314 a notification of a detection of an aspect. For example, the notification may be an alarm or other audible notification, a visual representation depicted on a display, an action by the IVL system 10 (e.g., automatically preventing further laser energy generation, closing shutters, etc.), or any combination thereof.

[0130] The processor 1302 may be similar to the CPU 518 depicted in FIG. 5 herein, wherein the processor may also be configured to enable and / or control operation of the IVL system 10. The processor 1302 also may be different from CPU 518, and may or may not be in communication with the CPU 518.

[0131] As illustrated in FIG. 13, the detector system 1301 may include detectors for detecting a respective aspect. For example, the detector system 1301 may include generator detector(s) 1304 for detecting aspects relating to the generator (see FIG. 14), optical fiber detector(s) for detecting aspects relating to the optical fiber (see FIG. 15), inflation fluid and balloon detector(s) 1308 for detecting aspects relating to the inflation fluid and / or balloon (see FIG.16), electrical detector(s) 1310 for detecting electrical related aspects 1701 (see FIG. 17), and / or coolant detector(s) 1312 for detecting coolant related aspects 1801 (see FIG. 18). There may be one or more detectors for detecting each aspect.

[0132] FIG. 14 illustrates exemplary generator related aspects 1401, wherein the generator detector(s) 1304 may include one or more detectors, each of which may be configured to detect one or more of the listed generator related aspects 1401 in FIG. 14. Each aspect may correspond to an event located within or outside the generator 304 housing. Similarly, each detector 1304 may be disposed within or outside the generator 304 housing (e.g., it may be disposed about the elongated body 202 and / or optical fiber 210, about the hub 214, etc.).

[0133] A first generator related aspect includes laser power 1402. Accordingly, a first exemplary generator detector includes the use of a power meter in optical communication with the optical pathway 718 within the generator 304, configured to measure the laser power. For example, the power meter may correspond to the main photodetector 824 and / or the safety photodetector 826 illustrated in FIG. 8D. As described herein, the main photodetector 824 and / or safety photodetector 826 is configured to receive a portion of the laser energy reflected by a partial reflector, such as wedged beam splitter 822, and measure an amount of optical power of the laser beam. Accordingly, the detector, as a power meter, may be configured to determine whether an optical power of the laser energy generated is greater than a thresholdPCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTvalue, less than a threshold value, and / or a change in the optical power of the laser energy is greater than a threshold. In some embodiments, an exemplary threshold includes a range that covers an estimated lower limit and / or upper limit of the laser power. For example, the threshold may include laser energy power being detected as + / - 5%, 10%, 15%, 20%, 25%, 30%, 50%, or 75% of a lower and / or upper limit of laser power. Upon said determination, the detector (e.g., power meter) may be configured to send a communication to the processor 1302 to output said detection of laser power being outside a desired range. The lower limit of laser energy power may be estimated as to the limit at which a shock wave will not be generated, or a weak shock wave is generated that may not crack calcium (for example) about the targeted region. The upper limit of laser energy may correspond to an estimate that correlates with risking collateral damage, for example due to the shock wave being too powerful. Each lower and / or upper limit for laser energy power may be determined empirically, for example optionally using cadaver tissue and / or imaging before and / or after.

[0134] Additionally or alternatively to a detector being a power meter disposed in the safety features 706 (e.g., main photodetector 824, safety photodetector 826), a detector as a power meter may be configured to measure any laser energy leakage elsewhere within the generator (for example). For example, another exemplary generator detector 1304 includes being able to detect for leakage 1404 of laser energy through the high reflector 802 (see FIG. 8A). For example, a power meter, which may be similar to main photodetector 824 and / or safety photodetector 826, may be disposed so as to be in optical communication with a side of the high reflector 802 opposite to the side facing the rod 808. Accordingly, the power meter (e.g., exemplary generator detector 1304) may be configured to detect for laser energy therethrough. The power meter may further be configured to detect whether an optical power of the laser energy leaking through the high reflector 802 is greater than a threshold value, less than a threshold value, and / or a change in the optical power of the laser energy greater than a threshold, in the case an expected leakage rate through the high reflector (which may be none). Upon said detection, the power meter may be configured to send a communication to the processor to output said detection.

[0135] Another exemplary generator related aspect includes a light intensity 1406 of the laser energy generator. The light intensity 1406 may correlate with the laser power 1402. The light intensity may correlate with an amount of laser energy per a unit area (at a given moment for example). The generator detector 1304 may include one or more photodiodes, such as an array of photodiodes, configured to detect for an intensity of the laser energy. The photodiodes may determine whether the measured light intensity is greater than a threshold value, less than aPCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTthreshold value, and / or a change in the intensity of the laser energy is greater than a threshold. Said photodiodes may be used in place and / or in addition to the power meter for detecting laser power 1402 and / or laser energy leakage 1404. While herein described as photodiodes, any sensor that converts optical energy to electrical energy may be used, such as pyro-electric detectors.

[0136] Another exemplary generator related aspect may be a pulse width 1408 of the laser energy. The generator detector 1304 may be an oscilloscope configured to determine the pulse width 1408 of the laser energy. In some cases, the oscilloscope is in communication with one or more photodiodes (e.g., an array of photodiodes), such that the oscilloscope is configured to measure a pulse width based on a light intensity measurement by the photodiodes. The photodiodes may be disposed anywhere along the optical pathway 718 within the generator 304, for example. The photodiodes may be the same aforementioned photodiodes used to measure a light intensity 1406 of the laser energy.

[0137] Another exemplary generator related aspect may be a pulse energy 1416 of the laser energy. The pulse energy may correlate with a total amount of energy within a single pulse of the laser energy. Accordingly, the generator detector 1304 may include a photodetector configured to receive the laser energy and output a signal (which may be modified and / or relayed to the processor), wherein such signal corresponds to the pulse energy. The generator related detector 1304 may also or alternatively include a pyroelectric detector configured to measure the pulse energy. The pyroelectric detector may be configured to measure a temperature increase corresponding to a change in the pulse energy. The pyroelectric detector may include a surface in it that converts the incoming light energy to heat in a sensitive and deterministic manner (e.g., X Joules or light quanta in, Y milliKelvin rise out). The heat being measured and / or change in heat correlates with the transient change in the pyroelectric detector temperature caused by the conversion of laser energy to heat, which may be used to correlate with the original light intensity.

[0138] Another exemplary generator related aspect relates to a peak power of the laser energy, wherein the peak power is based on dividing the pulse energy by the pulse width. The processor 1302 may be configured to use the generator detectors 1304 used to determine a pulse energy and pulse width of the laser energy to obtain the pulse peak. This would, for example, allow the system to distinguish between Q-switched and free-running laser pulses, which have different pulse widths and lead to different clinical outcomes.

[0139] Another exemplary generator related aspect relates to a lamp health, wherein the lamp is used to generate the laser energy. The lamp health may be monitored as a ratio between aPCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTlamp energy (for producing the laser energy) and laser power output (e.g., laser energy generated). An instrument, such as a wattmeter or Joule meter may be used to determine how much power was supplied (e.g., via a power supply as described herein) to the lamp for producing the laser energy. A photodetector, such as main and safety photodetectors (824, 826) may be used to determine the laser power output. A computing device (e.g., processor 1302) may be used to monitor the ratio, such that above a certain threshold, a fault may be indicated. For example, an increasing ratio, may suggest an increasing amount of power needed to be supplied to the lamp to generate a given laser power, thereby indicating a potential deteriorating health with the lamp and / or another fault (e.g., misalignment of the laser, burnt out optic, etc.).

[0140] Another exemplary generator related aspect may be related to a laser head, such as the laser resonator laser cavity 702. For example, the aspect related to a temperature of the laser head 1410. Accordingly, the generator detector 1304 may be configured to detect a temperature of the laser head. The detector may include a thermocouple, a resistance temperature detector (RTD), a thermistor, or any combination thereof, each configured to measure the temperature of the laser head 1410.

[0141] Another exemplary generator related aspect relates to an ultrasound intensity 1412, which may correlate with a pressure of the pressure wave generated by each pulse of the laser energy. Said pressure may be indicative of an aspect of the shock wave generated, particularly indicative of whether the pressure wave is appropriate for treatment. For example, too little or small of a pressure wave, may not be able to crack calcium within the vessel (for example), whereas too much or large of a pressure wave may result in collateral damage about the vessel or treatment region of the patent. The generator detector 1304 may be configured to detect the ultrasound intensity of the pressure of the pressure wave generated. The detector may include a hydrophone configured to measure the ultrasound intensity of the pressure wave, a change in refractive index as a function of time, or both. The hydrophone and / or a sensor associated with a hydrophone may be disposed within, on, or otherwise about the balloon (as described herein about the elongated tube). For example, the hydrophone and / or a sensor associated with a hydrophone may be disposed within the inflation fluid to detect changes in ultrasound intensity thereabout (for example).

[0142] Another exemplary generator related aspect relates to a humidity 1414 of an ambient environment surrounding the IVL system 10, a humidity within a housing of the generator 304, or both. Moisture in the generator, including the optical pathway may pose a risk for superheating water or other liquid, for example. The detector may include a hygrometerPCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTconfigured to measure the humidity. The hygrometer may be located outside, inside, or both, of the housing of the generator.

[0143] Another exemplary generator related aspect 1401 relates to a maximum acceleration 1418 experienced by the generator 304, the elongated body 202, the pressure wave emitter, other components of the IVL system 10, or any combination thereof. As such, the aspect may not necessarily be limited to a generator related aspect, but relate to structural and / or functional integrity of the IVL system components. For example, a maximum acceleration detected to exceed a certain threshold may result in the detector 1304 sending a communication to the processor (as described herein) to check for any faults and / or damage to components of the IVL system. This may have resulted if, for example, the IVL system or components thereof was dropped during transport, or movement otherwise (e.g., across a room, to a different room, etc.). The detector may include a gravity -force sensor and / or an accelerometer, which may be communicatively coupled to the generator 304 (in addition or alternate to being communicatively coupled to the processor). The gravity-force sensor and / or an accelerometer may be configured to be read at time of power-up of the generator (for example).

[0144] FIG. 15 illustrates exemplary aspects 1501 related to the optical fiber (e.g., 210), wherein the optical fiber detector(s) 1306 may include one or more detectors, each of which may be configured to detect one or more of the listed optical fiber related aspects 1501 in FIG.15. Each aspect may correspond to an event located within or about the optical fiber 210, and / or about an optical fiber connector (e.g., 306 in FIG. 3). Similarly, each detector 1306 may be disposed within or about the optical fiber 210, within or about the elongated body 202, within or about the hub 214, and / or within or about a housing of the generator 304. As described herein, the optical fiber 210 may be disposed within the elongated body 202, through which the laser energy travels to the pressure wave emitters within the treatment area 40.

[0145] An exemplary aspect relates to optical fiber interrogation 1502, relating to if the optical fiber 210, or at least one of the optical fibers, has broken, shattered, has a crack, fault or in other ways become disconnected. The optical fiber detector 1306 may include one or more photodiode (e.g., an array of photodiodes) configured to receive a back reflection of the laser energy from a distal end of the optical fiber, wherein the back reflection is indicative of the fiber interrogation. The back reflection may include a Fresnel reflection. The photodiodes may be configured to detect and measure an intensity of the reflected light. Any obstruction of this return pulse (e.g., via reflected light intensity) would correspond to a fault. Thus, the photodiodes may detect for an intensity of reflected laser energy greater than a threshold value, less than a threshold value, and / or a change in the intensity of the reflected laser energy greaterPCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTthan a threshold. The photodiodes may be disposed about the optical pathway, for e.g., within the housing of the generator 304, about the optical fiber connector 306, the hub 214, the optical fiber 210, and / or about the elongated tube.

[0146] One or more of the photodiodes may also be configured to detect for photon radiation, such as about the elongated tube, resulting from a shattering or crack in the optical fiber 210. Such an aspect to the optical fiber may result in the laser to be released to portion along the elongated tube that is in an unintended area of the patient, such as for example outside the treatment area 40 (as described herein). This release may result in harm or other injury to the patient. Such an aspect to the optical fiber may also result in a laser blast which may cause harm to the components within the generator 304, for example that may be disposed along the optical pathway within the generator.

[0147] Another exemplary detector 1306 for detecting fiber interrogation (i.e., an aspect of the optical fiber) includes an ultrasonic device configured to determine a break in the optical fiber. Yet another exemplary detector 1306 for detecting fiber interrogation may include a hydrophone. For example, the hydrophone may detect changes in ultrasound intensity, and / or an ultrasound intensity, either of which may correlate with a deviation from an expected value and further correlate with fiber interrogation. For example, if the laser energy is not effectively delivered, this may correlate with a shock wave having a reduced intensity.

[0148] Another exemplary optical fiber aspect includes a pressure 1504 of the optical fiber about a distal portion thereof, which may be used to correlate with an elastic modulus of surrounding vessel wall. The optical fiber detector 1306 may be an intravascular ultrasound (IVUS) configured to perform an ultrasound. Such detection of the fiber pressure may also provide feedback for the system regarding placement of the distal portion (e.g., distal end) of the optical fiber 210, such that the distal portion of the optical fiber is positioned based on the elastic modulus of the vessel wall. The detector 1306 may be configured to perform an intravascular ultrasound (IVUS) so as to map a treatment segment, thereby being able to map a calcified lesion on or about the vessel wall. For example, a reduced elasticity may represent an area of calcified lesion.

[0149] Another exemplary optical fiber aspect 1501 includes an aspect 1506 relating to the optical fiber connector 306. As described herein, the optical fiber connector 306 is configured to couple the optical fiber 210 to the generator 304. An aspect 1506 of the optical fiber connector may include a temperature of the optical fiber connector 512. The detector 1306 may include a thermocouple, a resistance temperature detector (RTD), at thermistor, an infraredPCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTsensor, or any combination thereof, each configured to measure a temperature of the optical fiber connector 306.

[0150] Another exemplary aspect of the optical fiber relates to a longitudinal position 1508 of the optical fiber 210 along the elongated body 202. For example, the optical fiber may be translatable along the elongated body, wherein the aspect relates to a longitudinal position of the distal end of the optical fiber (e.g., with respect to the elongated body). The detector 1306 may include an encoder configured to measure or determine the longitudinal position of the distal end of the optical fiber (e.g., with respect to the elongated body). The encoder may be disposed on or about i) a handle 412, ii) a hub 214, and / or iii) a sled 414, each of which may be coupled to the generator 304 and / or the elongated body 202. Alternatively or additionally, the detector may include a fluoroscopic device configured to measure the longitudinal position of the distal end of the optical fiber 210 using a marker band located on the distal end of the optical fiber or adjacent the distal end of the optical fiber.

[0151] Another exemplary aspect of the optical fiber relates to a rotational position 1510 of the optical fiber 210 about a central longitudinal axis 314 of the elongated body 202. For example, the optical fiber may be rotatable about the central longitudinal axis 314 of the elongated body 202, wherein the aspect relates to a rotational position of the distal end of the optical fiber (e.g., with respect to the elongated body). The detector 1306 may include an encoder configured to measure or determine the rotational position of the distal end of the optical fiber (e.g., with respect to the elongated body). The encoder may be disposed on or about i) a handle 412, ii) a hub 214, and / or iii) a sled 414, each of which may be coupled to the generator 304 and / or the elongated body 202. Alternatively or additionally, the detector may include a fluoroscopic device configured to measure the rotational position of the distal end of the optical fiber 210 using a marker band located on the distal end of the optical fiber or adjacent the distal end of the optical fiber.

[0152] Another exemplary aspect of the optical fiber relates to an angle of deflection 1512 of the optical fiber 210 with respect to a central longitudinal axis 314 of the elongated body 202. For example, the optical fiber may be deflectable about the central longitudinal axis 314 of the elongated body 202, wherein the aspect relates to an angle of deflection of the distal end of the optical fiber (e.g., with respect to the elongated body). The detector 1306 may include an encoder configured to measure or determine the angle of deflection of the distal end of the optical fiber (e.g., with respect to the elongated body). The encoder may be disposed on or about i) a handle 412, ii) a hub 214, and / or iii) a sled 414, each of which may be coupled to the generator 304 and / or the elongated body 202. Alternatively or additionally, the detector mayPCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTinclude a fluoroscopic device configured to measure the angle of deflection of the distal end of the optical fiber 210 using a marker band located on the distal end of the optical fiber or adjacent the distal end of the optical fiber.

[0153] Another exemplary aspect of the optical fiber relates to a blast shield position sensor 1514 configured to ensure a blast shield is inserted and / or properly inserted within the device (e.g., generator). The detector includes a sensor that detects for the blast shield being in place, for example, before operation of the device.

[0154] Another exemplary aspect of the optical fiber relates to a blast shield scattering 1516 of laser energy due to, for example, a break in the fiber, which may include fiber interrogation. The detector 1306 may include a photodiode (similar to photodiode 916 in FIGS. 9A / 9B for example) configured to detect for laser energy and laser energy scattering within the fiber focus assembly. For example, the photodiode within the fiber focus assembly may detect for a high scattering value of laser energy (e.g., higher than a threshold, or a change that exceeds a threshold).

[0155] FIG. 16 illustrates exemplary aspects 1601 related to the fluid pathway, which may include an aspect of the inflation fluid and / or the balloon, and wherein the inflation fluid and / or balloon (IFB) detector(s) 1308 may include one or more detectors, each of which may be configured to detect one or more of the listed IFB related aspects 1601 in FIG. 16. Each aspect may correspond to an event located within or about the balloon 208, elongated body 202, and / or about the fluid pathway. Similarly, each detector 1308 may be disposed within or about the balloon, within or about the elongated body 202, within or about the hub 214, and / or within or about a portion of the fluid pathway. As described herein, the inflation fluid may be delivered using a syringe to the fluid pathway (which may be via the hub, for example), and wherein inflation fluid travels within the elongated body 202, to inflate the balloon 208.

[0156] An exemplary aspect of the balloon may be a balloon pressure 1602, wherein the detector includes a pressure sensor configured to measure the balloon pressure. A sudden decrease of a pressure of the balloon pressure and / or pressure within the fluid pathway may correspond to a rupture of the balloon or other fault. The detector 1308 may include a pressure sensor for detecting the pressure of the balloon and / or fluid pathway. The pressure sensor may anywhere within the pressure pathway, wherein the pressure pathway defines a path beginning at the generator 304 and ending at the balloon 208. In some examples, the pressure sensor may be within the generator 304. According to some examples, the pressure sensor may be within the handle, sled, and / or hub 214, the intermediary component connecting the elongated body 202 to the generator 304 (in examples including a separate generator 304). The pressure sensorPCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTmay be present within the elongated body 202. In some examples, the pressure sensor may be located about the balloon 208. The pressure sensor may be present outside of these distinct components (generator 304, hub 214, elongated body 202) but within the pressure pathway.

[0157] Furthermore, in some examples, the pressure sensor may be present anywhere within the IVL system 10, including outside of the previously described pressure pathway. This could include a separate device outside of the medical device 12, such as an inflation device which is either a part of, or attached to, a hub connector. This inflation device may be adjacent, but outside of, the guidewire lumen. The pressure sensor may be a part of, or attached to, such an inflation device.

[0158] Another exemplary IFB aspect 1601 includes a temperature 1604 of the inflation fluid. In some cases, a high temperature of the inflation fluid may result in at least partial vaporization of the inflation fluid, which may result in gas bubbles in the inflation fluid within the bubble (which may interfere with the pressure wave generation by the laser energy, as described herein), and / or the vaporization may result in condensation upstream, such as within the generator 304. The detector 1308 may be configured to measure a temperature of the inflation fluid, a temperature along the elongated body 202, a temperature of the balloon, and / or an external temperature (external to the IVL system for example), such as an ambient temperature. The detector 1308 may include a thermocouple, a resistance temperature detector (RTD), at thermistor, or any combination thereof. In one example, the detector as a thermocouple may be disposed on an interior surface of the balloon, on an exterior surface of the balloon, within the balloon, or a combination thereof. A desired temperature of the inflation fluid may vary depending on the inflation fluid make-up. In some cases, a desired temperature of the inflation fluid is less than 30°C, less than 40°C, less than 45°C, less than 50°C, less than 60°C, or less than 75°C. The desired temperature may correlate to reducing or preventing the formation of bubbles and / or trapping gas within the inflation fluid. The desired temperature may be to reduce risk of injury and / or discomfort for a patient.

[0159] The detector 1308 may include an infrared sensor, configured to measure the temperature of the inflation fluid. The infrared sensor may be disposed about the elongated tube, and / or about the balloon.

[0160] The detector 1308 may also include a device to measure a direct current (DC) output. For example, the detector 1308 may be a multimeter. The DC current output may be correlated with a refractive index, which may be correlated with the temperature of the inflation fluid. ForPCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTexample, an increasing refractive index may be correlated with a decreasing inflation fluid (e.g., saline) temperature.

[0161] Another exemplary IFB aspect 1601 includes bubble formation within the inflation fluid within the balloon, as described herein (e.g., bubble not formed via the laser energy). Bubbles within the inflation fluid may disrupt the formation of pressure waves by the laser energy. Accordingly, such bubble formation 1606 detection may be indicative of an amount, and / or an increased amount of gas trapped in the balloon 1608. The detector 1308 may include i) an x-ray device configured to measure the bubble formation 1606 and / or ii) an additional optical fiber configured to measure the bubble formation 1606.

[0162] Additionally or alternatively, the detector 1308 may include one or more photodiodes (e.g., an array of photodiodes) configured to detect light, wherein such detection of light may be used to determine whether there has been bubble formation. For example, the photodiodes may be configured to receive a back reflection, of the laser energy, from a distal portion (e.g., distal end) of the optical fiber, wherein the light intensity measured from the back reflection may be indicative of bubble formation and / or fiber interrogation. The back reflection may correspond to a Fresnel reflection.

[0163] Additionally or alternatively, the detector 1308 may include an ultrasound device configured to measure an ultrasound intensity, which may be correlated with formation of a bubble within the fluid. For example, the ultrasound intensity may correlate with a pressure of each pulse of the laser energy. The detector 1308 may also or alternatively include a hydrophone to measure the ultrasound intensity, to detect for bubble formation within the fluid.

[0164] FIG. 17 illustrates exemplary aspects related to the electrical pathway and certain electrical related components of the IVL system 10, and wherein the electrical detector(s) 1310 may include one or more detectors, each of which may be configured to detect one or more of the listed electrical related aspects 1701 in FIG. 17. Each aspect may correspond to an event located within or about the power supply 302, the generator 304, the hub 214, and / or a component about the electrical pathway. Similarly, each detector 1310 may be disposed within or about the power supply, within or about the generator 304, within or about the hub 214, and / or within or about a portion of the electrical pathway. As described herein, and illustrated in, for example, FIG. 3, a power supply 302 may be configured to couple with an external power source (such as via a power outlet and using a power cord 308), and / or may be included with a battery. The power supply 302 may be configured to be electrically coupled with the generator 304 so as to deliver electrical power thereto and / or other components of the IVL system 10 (which may include, for example, creating the laser energy).PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCT

[0165] An electrical related aspect 1701 may include an aspect relating to the power supply 302, the electrical power supplied by the power supply 302, and / or the voltage 1704 supplied to the generator 304 and / or other components of the IVL system. For example, too high of a voltage supplied may damage the downstream user. The detector 1310 may include a voltmeter configured to measure the voltage supplied by the power supply and / or electrical power delivered to the generator. In another example, too low of voltage may not provide sufficient power for the desired pulse energy of the laser to be generated, thereby potentially impacting the effectiveness in breaking up calcified lesions.

[0166] FIG. 18 illustrates exemplary aspects related to the coolant flow pathway and coolant system, and wherein the coolant detector(s) 1312 may include one or more detectors, each of which may be configured to detect one or more of the listed coolant related aspects 1801 in FIG. 18. Each aspect may correspond to an event located within or about the coolant flow pathway and / or coolant system. Similarly, each detector 1312 may be disposed within or about the coolant flow system, including pathway, and / or generator 304. As described herein, a coolant may flow through a coolant flow pathway (e.g., within the generator 304) so as to keep components (e.g., within the generator 304) cool during operation, thereby helping reduce a risk of overheating of the equipment and / or potentially the inflation fluid.

[0167] An exemplary coolant related aspect 1801 includes a flow rate 1802 of the coolant. The detector 1312 may include a flow meter, an ultrasonic device, and / or a calorimeter for measuring the flow rate of the coolant. The flow meter may be configured to spin in response to a coolant flow, and thereby convert said rotation to an electrical current. The ultrasonic device may include a hydrophone. The flow meter, ultrasonic device, and / or calorimeter may be located along the coolant flow pathway. The coolant flow system may include a hose pipe that is a part of or in fluid communication of the coolant flow pathway, wherein the flowmeter, ultrasonic device, and / or calorimeter are located in line with the hose pipe.

[0168] Another exemplary coolant related aspect 1801 may include a conductivity 1804 of the coolant. The detector 1312 may include a conductivity sensor configured to measure a conductivity of the coolant (another exemplary aspect of the coolant). The conductivity sensor may be located along the coolant flow pathway.

[0169] Another exemplary coolant related aspect 1801 may include the temperature 1806 of the coolant. The detector 1312 may include being configured to measure of a temperature of the coolant (aspect of the coolant). The detector 1312 may be a thermocouple, and may be disposed along the coolant flow pathway and / or about a coolant reservoir that is a part of the IVL system.PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCT

[0170] Another exemplary coolant related aspect 1801 may include the pressure 1808 of the coolant. The detector 1312 may be configured to measure a pressure of the coolant (an aspect of the coolant). The detector may be a pressure sensor, which may be located along or about the coolant flow pathway.

[0171] Another exemplary coolant related aspect 1801 may include the coolant reservoir level of the coolant, reservoir volume 1810. The detector 1312 may be configured to measure a level of the coolant in the reservoir, which may correlate with an amount of the coolant within the system (an aspect of the coolant). The detector may be a level sensor, which may be located along or about a coolant reservoir in fluid communication with the coolant flow pathway.

[0172] None of the steps described herein is essential or indispensable. Any of the steps can be adjusted or modified. Other or additional steps can be used. Any portion of any of the steps, processes, structures, and / or devices disclosed or illustrated in one embodiment, flowchart, or example in this specification can be combined or used with or instead of any other portion of any of the steps, processes, structures, and / or devices disclosed or illustrated in a different embodiment, flowchart, or example. The embodiments and examples provided herein are not intended to be discrete and separate from each other.

[0173] The section headings and subheadings provided herein are nonlimiting. The section headings and subheadings do not represent or limit the full scope of the embodiments described in the sections to which the headings and subheadings pertain. For example, a section titled “Topic 1” may include embodiments that do not pertain to Topic 1, and embodiments described in other sections may apply to and be combined with embodiments described within the “Topic 1” section.

[0174] To increase the clarity of various features, other features are not labeled in each figure.

[0175] The various features and processes described above may be used independently of one another or may be combined in various ways. All possible combinations and subcombinations are intended to fall within the scope of this disclosure. In addition, certain method, event, state, or process blocks may be omitted in some implementations. The methods, steps, and processes described herein are also not limited to any particular sequence, and the blocks, steps, or states relating thereto can be performed in other sequences that are appropriate. For example, described tasks or events may be performed in an order other than the order specifically disclosed. Multiple steps may be combined in a single block or state. The example tasks or events may be performed in serial, parallel, or some other manner. Tasks or events may be added to or removed from the disclosed example embodiments. The example systems and components described herein may be configured differently than described. For example,PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTelements may be added to, removed from, or rearranged compared to the disclosed example embodiments.

[0176] Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless expressly stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and / or steps. Thus, such conditional language is not generally 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 deciding, with or without author input or prompting, whether these features, elements and / or steps are included or are to be performed in any particular embodiment. The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless expressly stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y, and at least one of Z to each be present.

[0177] 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 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 can include A and B, some embodiments can include A and C, some embodiments can include B and C, some embodiments can only include A, some embodiments can include only B, some embodiments can include only C, and some embodiments can include A, B, and C. The term “and / or” is used to avoid unnecessary redundancy.

[0178] While certain example embodiments have been described, these embodiments have been presented by way of example only and are not intended to limit the scope of the inventions disclosed herein. Thus, nothing in the foregoing description implies that any particular feature, characteristic, step, module, or block is necessary or indispensable. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms; furthermore, various omissions, substitutions, and changes in the form of the methods and systems described herein may be made without departing from the spirit of the inventions disclosed herein.

Claims

PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTCLAIMSWe Claim:

1. A system, comprising:an elongated body comprising a guidewire lumen;a pressure wave emitter disposed about the elongated body and comprising an optical fiber configured to transmit laser energy into a fluid to create plasma, a cavitation, or both, in the fluid, such that the laser energy is configured to enable a pressure wave to be generated;a generator configured to couple with the pressure wave emitter and deliver the laser energy thereto via an optical pathway; anda detector configured to detect i) an aspect of the laser energy along the optical pathway, ii) an aspect of the optical fiber, or iii) both.

2. The system of Claim 1, wherein the elongated body comprises an inner elongated structure, the inner elongated structure comprising the guidewire lumen.

3. The system of Claim 1 or 2, wherein the pressure wave emitter is positioned along a central longitudinal axis of the elongated body.

4. The system of any one of Claims 1-3, wherein the aspect of the optical fiber is a shattering of the optical fiber or a crack in the optical fiber.

5. The system of Claim 4, wherein the detector comprises an array of photodiodes located along the optical pathway configured to detect a change in photon radiation in the optical pathway that corresponds to the shattering of the optical fiber or the crack in the optical fiber.

6. The system of Claim 4 or 5, further comprising a blast shield configured to protect the generator from debris, laser blast, or both, resulting from the shattering of the optical fiber or the crack in the optical fiber.

7. The system of any one of Claims 1-6, further comprising a partial reflector located along the optical pathway, the partial reflector configured to reflect a portion of the laser energy.PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCT8. The system of Claim 7, wherein the detector comprises a power meter configured to receive the portion of the laser energy and measure an amount of an optical power thereof, so as to detect for a change in the detected amount of optical power from an expected amount, a previous amount, or both, by a predetermined tolerance.

9. The system of Claim 8, wherein the power meter is disposed within a housing of the generator.

10. The system of Claim 7, wherein the detector comprises an array of photodiodes configured to receive the portion of the laser energy and measure an intensity thereof, so as to detect for a change in a detected amount of optical power from an expected amount, a previous amount, or both, by a predetermined tolerance.

11. The system of any one of Claims 1-10, further comprising a high reflector along the optical pathway.

12. The system of Claim 11, wherein the detector comprises a power meter, an array of photodiodes, or both.

13. The system of Claim 12, wherein the power meter, the array of photodiodes, or both is configured to receive leakage of the laser energy from a side of the high reflector opposite to where at least some of the laser energy is configured to be reflected from, wherein the optical pathway extends distally from the high reflector to the pressure wave emitter.

14. The system of any one of Claims 1-13, wherein the aspect of the laser energy is a pulse width.

15. The system of Claim 14, wherein the detector comprises an oscilloscope, the oscilloscope in communication with an array of photodiodes, so as to be configured to measure a pulse width of the laser energy via light intensity measurement by the array of photodiodes.

16. The system of any one of Claims 1-15, wherein the aspect of the optical fiber is a fiber interrogation.

17. The system of Claim 16, wherein the detector comprises an ultrasonic device configured to determine a break in the optical fiber.PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCT18. The system of Claim 17, wherein the ultrasonic device comprises a hydrophone.

19. The system of any one of Claims 16-18, wherein the detector comprises an array of photodiodes configured to receive a back reflection of the laser energy from a distal end of the optical fiber, the back reflection indicative of the fiber interrogation.

20. The system of Claim 19, wherein the back reflection from the distal end of the optical fiber comprises a Fresnel reflection.

21. The system of any one of Claims 1-20, wherein the generator comprises a laser head configured to generate the laser energy.

22. The system of Claim 21, wherein the detector is configured to determine an aspect of the laser head.

23. The system of Claim 22, wherein the aspect of the laser head is a temperature of the laser head.

24. The system of Claim 23, wherein the detector comprises a thermocouple, a resistance temperature detector (RTD), a thermistor, or any combination thereof, each configured to measure the temperature of the laser head.

25. The system of any one of Claims 1-24, wherein the aspect of the laser energy is an ultrasound intensity.

26. The system of Claim 25, wherein the ultrasound intensity is indicative of a pressure of each pulse associated with the laser energy.

27. The system of Claim 26, wherein the detector comprises a hydrophone configured to measure i) the ultrasound intensity, ii) a refractive index change as a function of time, or iii) both.

28. The system of Claim 26 or 27, wherein measuring the pressure of each pulse provides a feedback on whether the pressure wave being generated is appropriate for a treatment.

29. The system of any one of Claims 1-28, wherein the detector is configured to determine a humidity of an ambient environment i) about the system, ii) within the generator, or iii) both.PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCT30. The system of Claim 29, wherein the detector comprises a hygrometer configured to measure the humidity.

31. The system of any one of Claims 1-30, wherein the detector is configured to determine an elastic modulus of a vessel wall within a subject.

32. The system of Claim 31, wherein the aspect of the optical fiber is a pressure on a distal end of the optical fiber that correlates with the elastic modulus of the vessel wall.

33. The system of Claim 32, wherein the distal end of the optical fiber is configured to be positioned based on the elastic modulus of the vessel wall.

34. The system of Claim 32 or 33, wherein the detector is further configured to perform an intravascular ultrasound (IVUS) configured to map a treatment segment, so as to map a calcified lesion on the vessel wall.

35. The system of any one of Claims 1-34, wherein the detector is configured to determine a maximum acceleration experienced by the generator, the elongated body, the detector, the pressure wave emitter, or any combination thereof.

36. The system of Claim 35, wherein the detector comprises a gravity-force sensor, an accelerometer, or both.

37. The system of any one of Claims 1-36, wherein the detector is configured to determine a bubble formation within the fluid.

38. The system of Claim 37, wherein the bubble formation is indicative of an increased amount of gas in the fluid.

39. The system of Claim 37 or 38, wherein the detector comprises i) an x-ray device configured to measure the bubble formation, ii) an additional optical fiber configured to measure the bubble formation, or iii) both.

40. The system of any one of Claims 37-39, wherein the detector comprises an array of photodiodes configured to detect light, thereby enabling detection of the bubble formation.PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCT41. The system of Claim 40, wherein the array of photodiodes is configured to receive a back reflection from a distal end of the optical fiber.

42. The system of Claim 41, wherein the back reflection from the distal end of the optical fiber comprises a Fresnel reflection.

43. The system of any one of Claims 37-42, wherein the detector comprises an ultrasound device configured to measure an ultrasound intensity, and wherein the ultrasound intensity is indicative of the bubble formation.

44. The system of Claim 43, wherein the ultrasound intensity is indicative of a pressure of each pulse of the laser energy.

45. The system of Claim 43 or 44, wherein the detector comprises a hydrophone configured to measure the ultrasound intensity, such that a change thereof is indicative of the bubble formation.

46. The system of any one of Claims 1-45, wherein the optical fiber is translatable along the elongated body.

47. The system of Claim 46, wherein the aspect of the optical fiber is a longitudinal position of a distal end of the optical fiber.

48. The system of Claim 47, wherein the detector comprises an encoder configured to measure the longitudinal position of the distal end of the optical fiber.

49. The system of Claim 48, further comprising a handle coupled to one or more of the generator and the elongated body, wherein the handle comprises the encoder.

50. The system of Claim 48, further comprising a hub coupled to one or more of the generator and the elongated body, wherein the hub comprises the encoder.

51. The system of Claim 48, further comprising a sled coupled to one or more of the generator and the elongated body, wherein the sled comprises the encoder.

52. The system of any one of Claims 1-51, wherein the optical fiber is rotatable with respect to a central longitudinal axis of the elongated body.PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCT53. The system of Claim 52, wherein the aspect of the optical fiber is a rotational position of a distal end of the optical fiber.

54. The system of Claim 53, wherein the detector comprises an encoder configured to measure the rotational position of the distal end of the optical fiber.

55. The system of Claim 54, further comprising a handle coupled to one or more of the generator and the elongated body, wherein the handle comprises the encoder.

56. The system of Claim 54, further comprising a hub coupled to one or more of the generator and the elongated body, wherein the hub comprises the encoder.

57. The system of Claim 54, further comprising a sled coupled to one or more of the generator and the elongated body, wherein the sled comprises the encoder.

58. The system of any one of Claims 1-57, wherein the optical fiber is deflectable with respect to a central longitudinal axis of the elongated body.

59. The system of Claim 58, wherein the aspect of the optical fiber is an angle of deflection of a distal end of the optical fiber.

60. The system of Claim 59, wherein the detector comprises a rotational encoder configured to measure the angle of deflection of the distal end of the optical fiber.

61. The system of Claim 60, further comprising a handle coupled to one or more of the generator and the elongated body, wherein the handle comprises the rotational encoder.

62. The system of Claim 60, further comprising a hub coupled to one or more of the generator and the elongated body, wherein the hub comprises the rotational encoder.

63. The system of Claim 60, further comprising a sled coupled to one or more of the generator and the elongated body, wherein the sled comprises the rotational encoder.

64. The system of any one of Claims 46-63, further comprising a marker band located on a distal end of the optical fiber or adjacent the distal end of the optical fiber.PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCT65. The system of Claim 64, wherein the detector comprises a fluoroscopic device configured to measure i) a longitudinal position of the distal end of the optical fiber, ii) a rotational position of the distal end of the optical fiber, iii) an angle of deflection of the distal end of the optical fiber, or iv) any combination thereof, using the marker band.

66. The system of any one of Claims 1-65, wherein the aspect of the laser energy is a pulse energy.

67. The system of Claim 66, wherein the detector comprises a photodetector configured to receive the laser energy and output a signal, the signal indicative of the pulse energy.

68. The system of Claim 66 or 67, wherein the detector further comprises a pyroelectric detector configured to measure the pulse energy.

69. The system of Claim 68, wherein the pyroelectric detector is configured to measure a temperature increase corresponding to a change in the pulse energy of the laser energy.

70. The system of any one of Claims 1-69, wherein the aspect of the laser energy is a peak power.

71. The system of Claim 70, wherein the peak power is measured through obtaining a pulse energy and a pulse width, the peak power being measured by dividing the pulse energy by the pulse width.

72. The system of Claim 71 , wherein the detector is configured to measure the pulse energy, the pulse width, or both, of the laser energy.

73. A system, comprising:an elongated body comprising a guidewire lumen;a pressure wave emitter disposed about the elongated body and comprising an optical fiber configured to transmit laser energy into a fluid to create plasma, a cavitation bubble, or both in the fluid, such that the laser energy is configured to enable a pressure wave to be generated;a generator coupled with the pressure wave emitter;a power supply coupled to the generator and configured to supply electrical power to the generator; andPCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTa detector configured to detect an aspect of the power supply, the electrical power supplied by the power supply, or the generator.

74. The system of Claim 73, wherein the elongated body comprises an inner elongated structure, the inner elongated structure comprising the guidewire lumen.

75. The system of Claim 73 or 74, wherein the pressure wave emitter is positioned along a central longitudinal axis of the elongated body.

76. The system of any one of Claims 73-75, wherein the aspect of the electrical power is a voltage.

77. The system of Claim 76, wherein the detector comprises a voltmeter configured to measure the voltage.

78. A system, comprising:an elongated body comprising a guidewire lumen;a balloon positioned at a first end of the elongated body, the balloon configured to receive an inflation fluid to inflate the balloon;an inflation lumen extending from a second end of the elongated body into the balloon, thereby forming a fluid pathway;a pressure wave emitter disposed about the elongated body and comprising an optical fiber configured to transmit laser energy into the inflation fluid to create plasma, a cavitation bubble, or both, in the inflation fluid, such that the laser energy is configured to enable a pressure wave to be generated; anda detector configured to detect an aspect of the inflation fluid along the fluid pathway or an aspect of the balloon.

79. The system of Claim 78, wherein the elongated body comprises an inner elongated structure, the inner elongated structure comprising the guidewire lumen.

80. The system of Claim 78 or 79, wherein the pressure wave emitter is positioned along a central longitudinal axis of the elongated body.PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCT81. The system of any one of Claims 78-80, wherein the aspect of the balloon is a balloon pressure.

82. The system of Claim 81, wherein the detector comprises a pressure sensor configured to measure the balloon pressure.

83. The system of Claim 82, wherein the pressure sensor is located along the fluid pathway.

84. The system of Claim 82, further comprising a handle located along the fluid pathway, the handle coupled to one or more of the generator and the elongated body, wherein the pressure sensor is disposed on or about the handle.

85. The system of Claim 82, further comprising a hub located along the fluid pathway, the hub coupled to one or more of the generator and the elongated body, wherein the pressure sensor is disposed on or about the hub.

86. The system of Claim 82, further comprising a sled located along the fluid pathway, the sled coupled to one or more of the generator and the elongated body, wherein the pressure sensor is disposed on or about the sled.

87. The system of any one of Claims 78-86 wherein the detector is configured to detect an external temperature or a temperature relating to the system.

88. The system of Claim 87, wherein the external temperature is indicative of an ambient temperature.

89. The system of Claim 87 or 88, wherein the detector comprises a thermocouple, a resistance temperature detector (RTD), a thermistor, or any combination thereof, each configured to measure the external temperature.

90. The system of Claim 89, wherein the detector comprises the thermocouple, the thermocouple being disposed on an interior surface of the balloon, on an exterior surface of the balloon, or within the balloon.

91. The system of any one of Claims 78-90, wherein the aspect of the inflation fluid is a temperature of the inflation fluid.PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCT92. The system of Claim 91, wherein the detector comprises an infrared sensor configured to measure the temperature of the inflation fluid, corresponding to an external temperature.

93. The system of Claim 92, wherein the balloon comprises the infrared sensor.

94. The system of any one of Claims 91-93, wherein the detector comprises an infrared sensor configured to measure the temperature of the inflation lumen.

95. The system of Claim 94, wherein a refractive index is measured, the refractive index indicative of the temperature of the inflation fluid.

96. The system of Claim 95, wherein the refractive index is measured as a direct current (DC) output.

97. The system of any one of Claims 78-96, further comprising an optical fiber connector configured to couple the optical fiber to the generator.

98. The system of Claim 97, wherein the detector is configured to detect a temperature of the optical fiber connector.

99. The system of Claim 98, wherein the detector comprises a thermocouple, a resistance temperature detector (RTD), a thermistor, or any combination thereof, each configured to measure the temperature of the optical fiber connector.

100. The system of Claim 99, wherein the detector comprises the thermocouple, thermocouple being located on an interior surface of the balloon, on an exterior surface of the balloon, or within the balloon.

101. The system of any one of Claims 98-100, wherein the detector comprises an infrared sensor configured to measure the temperature of the optical fiber connector.

102. A system, comprising:an elongated body comprising a guidewire lumen;a pressure wave emitter disposed about the elongated body and comprising an optical fiber configured to transmit laser energy into a fluid to create plasma, a cavitation bubble, orPCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTboth, in the fluid, such that the laser energy is configured to enable a pressure wave to be generated;a generator coupled with the pressure wave emitter,wherein the generator comprises a coolant flow pathway configured to deliver coolant to one or more components of the generator; anda detector configured to detect an aspect of the coolant or the coolant flow pathway.

103. The system of Claim 102, wherein the elongated body comprises an inner elongated structure, the inner elongated structure comprising the guidewire lumen.

104. The system of Claim 102 or 103, wherein the pressure wave emitter is positioned along a central longitudinal axis of the elongated body.

105. The system of any one of Claims 102-104, wherein the aspect of the coolant is a flow rate of the coolant.

106. The system of Claim 105, wherein the detector comprises a flow meter configured to measure the flow rate of the coolant.

107. The system of Claim 106, wherein the flow meter is configured to spin in response to a coolant flow and thereby convert a rotation to an electrical current.

108. The system of Claim 106 or 107, further comprising a hose pipe located along the coolant flow pathway, wherein the flow meter is located in line with the hose pipe.

109. The system of any one of Claims 102-108, wherein the detector comprises an ultrasonic device configured to measure a flow rate of the coolant.

110. The system of Claim 109, wherein the ultrasonic device comprises a hydrophone.

111. The system of any one of Claims 102- 110, wherein the detector comprises a calorimeter configured to measure the flow rate of the coolant.

112. The system of any one of Claims 102-111, wherein the aspect of the coolant is a conductivity of the coolant.PCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCT113. The system of Claim 112, wherein the detector comprises a conductivity sensor configured to measure the conductivity of the coolant.

114. The system of Claim 113, wherein the conductivity sensor is located along the coolant flow pathway.

115. The system of any one of Claims 102-114, wherein the aspect of the coolant is a temperature of the coolant.

116. The system of Claim 115, wherein the detector comprises a thermocouple configured to measure the temperature of the coolant.

117. The system of Claim 116, wherein the thermocouple is located along the coolant flow pathway.

118. The system of any one of Claims 102-117, wherein the aspect of the coolant is a pressure of the coolant.

119. The system of Claim 118, wherein the detector comprises a pressure sensor configured to measure the pressure of the coolant.

120. The system of Claim 118 or 119, wherein the pressure sensor is located along the coolant flow pathway.

121. The system of any one of Claims 1-120, wherein the detector is in communication with a processor configured to output a respective detection by the detector.

122. The system of Claim 121, wherein the output comprises a visual output depicted on a display that is in communication with the processor, an audio output, a communication sent to an interested party, an automatic shutdown of one or more components of the system, or any combination thereof.

123. The system of any one of Claims 1-122, further comprising a connector located along the optical fiber pathway proximal to the pressure wave emitter.

124. The system of Claim 123, wherein the connector comprises i) a subminiature version A (SMA) connector, ii) a ferrule connector (FC), iii) a subscriber connector (SC), iv) a straightPCT UTILITY APPLICATION DOCKET NO. FASTWAVE-012PCTtip (ST) connector, v) an FC angled physical contact (FC-APC) connector, or vi) an SC physical contact (SC-PC) connector.

125. The system of Claim 123 or 124, wherein the connector comprises an angled face of from about 0.5 degrees to about 15 degrees.

126. The system of Claim 125, wherein the connector comprises an angled face from about 6 degrees to about 9 degrees.

127. The system of Claim 125, wherein the connector comprises an angled face of 2 degrees.

128. The system of any of Claims 1-127, further comprising a position sensitive detector configured to detect a position of returning laser energy with respect to a nominal position.

129. The system of any of Claims 1-128, further comprising a polarization diversity detector configured to detect an overall intensity of laser energy via a polarization of outgoing laser energy and returning laser energy.

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