Pleatless delivery intravascular lithotripsy system

Abstract

Included in the present disclosure is a medical device, including an elongated body, a balloon positioned at a distal portion of the elongated body configured to receive a fluid to inflate such that an exterior surface of the balloon is configured to contact an interior surface of a treatment site within a vasculature of a patient, and configured to transition between an uninflated state and an inflated state. When the balloon is in the uninflated state, the balloon may be pleatless. The medical device may include one or more pressure-wave emitters positioned along a central longitudinal axis of the elongated body within the balloonconfigured to propagate pressure waves radially outward through the fluid. At least one of the pressure-wave emitters may include an optical fiber configured to transmit laser energy into the balloon, the laser energy configured to create a cavitation bubble in the fluid to generate the pressure waves.

Description

PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCTPLEATLESS DELIVERY INTRAVASCULAR LITHOTRIPSY SYSTEMCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The entire contents of the following application are incorporated herein: U.S. Provisional Patent Application No. 63 / 679,562; filed on August 5, 2024; and entitled INTRAVASCULAR LITHOTRIPSY SYSTEM WITH COMPLIANT BALLOON.TECHNICAL FIELD

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

[0003] During an intravascular lithotripsy (IVL) procedure, a clinician uses a catheter configured to break apart calcified-plaque lesions within a patient’s vasculature. Some such methods include the creation and rapid collapse of cavitation bubbles to create a shock wave, which causes this calcification break-up.SUMMARY

[0004] Included in the present disclosure is a medical device, including an elongated body. In some embodiments, the medical device includes a balloon positioned at a distal portion of the elongated body, the balloon configured to receive a fluid to inflate such that an exterior surface of the balloon is configured to contact an interior surface of a treatment site within a vasculature of a patient, the balloon configured to transition between an uninflated state and an inflated state. According to some embodiments, when the balloon is in the uninflated state, the balloon is pleatless. The medical device may include one or more pressure-wave emitters positioned along a central longitudinal axis of the elongated body within the balloon, the one or more pressure-wave emitters configured to propagate pressure waves radially outward through the fluid to fragment a calcified lesion at the treatment site. In some embodiments, at least one of the pressure-wave emitters includes an optical fiber configured to transmit laser energy into the balloon. According to some embodiments, the laser energy is configured to create a cavitation bubble in the fluid to generate the pressure waves.

[0005] The balloon may be a first balloon, and the medical device may further include a second balloon positioned proximal to the first balloon and on or about the elongated body, the secondPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT balloon configured to receive a fluid to inflate such that an exterior surface of the second balloon is configured to increase dilation of the vasculature at the treatment site.

[0006] In some embodiments, the first balloon is a compliant balloon. According to some embodiments, the second balloon is either i) a semi-compliant balloon or ii) a non-compliant balloon.

[0007] Also included in the present disclosure is a medical device, including an elongated body. In some embodiments, the medical device includes a balloon positioned at a distal portion of the elongated body, the balloon containing a fluid prior to being delivered to a treatment site within a vasculature of a patient, the balloon configured to transition between an untensioned state and a tensioned state such that, when the balloon is in the untensioned state, an exterior surface of the balloon is configured to contact an interior surface of the treatment site. According to some embodiments, the medical device includes one or more pressure-wave emitters positioned along a central longitudinal axis of the elongated body within the balloon, the one or more pressure-wave emitters configured to propagate pressure waves radially outward through the fluid to fragment a calcified lesion at the treatment site. At least one of the pressure-wave emitters may include an optical fiber configured to transmit laser energy into the balloon. In some embodiments, the laser energy is configured to create a cavitation bubble in the fluid to generate the pressure waves.

[0008] According to some embodiments, when the balloon is in the tensioned state, an outer diameter of the balloon is less than an outer diameter of the balloon in the untensioned state.

[0009] The medical device may further include a wire positioned along the elongated body and attached to a proximal portion of the balloon. In some embodiments, pulling on the wire causes the balloon to be in the tensioned state. According to some embodiments, pushing on the wire causes the balloon to be in the untensioned state. An absence of force on the wire may cause the balloon to be in the untensioned state.

[0010] In some embodiments, the medical device further includes a wire positioned along the elongated body and attached to a distal portion of the balloon. According to some embodiments, pushing on the wire causes the balloon to be in the tensioned state. Pulling on the wire may cause the balloon to be in the untensioned state. In some embodiments, an absence of force on the wire causes the balloon to be in the untensioned state.

[0011] According to some embodiments, the balloon is a first balloon. The medical device may further include a second balloon positioned proximal to the first balloon and on or about the elongated body, the second balloon configured to receive a fluid to inflate such that an exteriorPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT surface of the second balloon is configured to increase dilation of the vasculature at the treatment site.

[0012] Also included in the present disclosure is a medical device, including an elongated body. In some embodiments, the medical device includes a balloon positioned at a distal portion of the elongated body, the balloon configured to permit ingress of blood disposed within a vasculature of a patient, so as to inflate an exterior surface of the balloon, the exterior surface thereby configured to contact an interior surface of a treatment site within the vasculature of the patient. According to some embodiments, the medical device includes one or more pressure-wave emitters positioned along a central longitudinal axis of the elongated body within the balloon, the one or more pressure-wave emitters configured to propagate pressure waves radially outward through the blood to fragment a calcified lesion at the treatment site. At least one of the pressure-wave emitters may include an optical fiber configured to transmit laser energy into the balloon. In some embodiments, the laser energy is configured to create a cavitation bubble in the blood to generate the pressure waves.

[0013] According to some embodiments, the balloon is a first balloon. The medical device may further include a second balloon positioned proximal to the first balloon and on the elongated body, the second balloon configured to receive a fluid to inflate such that an exterior surface of the second balloon is configured to increase dilation of the vasculature at the treatment site. In some embodiments, the first balloon is a compliant balloon. According to some embodiments, the second balloon is either i) a semi-compliant balloon or ii) a non-compliant balloon.

[0014] Also included in the present disclosure is a medical device, including an elongated body. In some embodiments, the medical device includes a balloon wound about a distal portion of the elongated body, the balloon configured to receive a fluid to inflate such that an exterior surface of the balloon is configured to contact an interior surface of a treatment site within a vasculature of a patient in a helical manner. According to some embodiments, the medical device includes one or more pressure-wave emitters positioned along a central longitudinal axis of the elongated body within the balloon, the one or more pressure-wave emitters configured to propagate pressure waves radially outward through the fluid to fragment a calcified lesion at the treatment site. At least one of the pressure-wave emitters may include an optical fiber configured to transmit laser energy into the balloon. In some embodiments, the optical fiber is configured to wind about the distal portion of the elongated body within the balloon. According to some embodiments, the laser energy is configured to create a cavitation bubble in the fluid to generate the pressure waves.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT

[0015] The balloon may be a compliant balloon. In some embodiments, a distal end of the balloon includes a bull nose. According to some embodiments, the bull nose extends distally with respect to a distal end of the elongated body.

[0016] The balloon may include a through lumen extending longitudinally through the balloon, the through lumen configured to permit a passage of a fluid through the balloon separate from an interior of the balloon while the balloon is in an expanded state. In some embodiments, the fluid is blood. According to some embodiments, the through lumen is configured to permit blood to at least partially flow through the balloon separate from the interior of the balloon while the balloon is in the expanded state. The through lumen may be one of a plurality of through lumens extending through the balloon.

[0017] In some embodiments, the medical device further includes a constraining feature located on an exterior surface of the balloon, the constraining feature configured to prevent a portion of the balloon from expanding beyond the constraining feature. According to some embodiments, the portion of the balloon prevented from expanding beyond the constraining feature is configured to permit blood to flow past the balloon through the vasculature. The constraining feature may be one of a plurality of constraining features of the medical device.

[0018] In some embodiments, the balloon is pleatless when in an unexpanded state. According to some embodiments, the unexpanded state is i) a state of deflation or ii) a state of longitudinal tension.

[0019] Also included in the present disclosure is a method, including inserting a first medical device including a first balloon into a treatment site within a vasculature of a patient. In some embodiments, the method includes inflating the first balloon such that an exterior surface of the first balloon contacts an interior surface of the treatment site. According to some embodiments, the method includes forming pressure waves inside the first balloon. The method may include removing the first medical device from the treatment site. In some embodiments, the method includes inserting a second medical device including a second balloon into the treatment site. According to some embodiments, the method includes inflating the second balloon such that an exterior surface of the second balloon causes increased dilation of the vasculature at the treatment site. The method may include removing the second medical device from the treatment site.

[0020] In some embodiments, the first balloon includes a compliant material. According to some embodiments, the second balloon includes either i) a semi-compliant material or a ii) non-compliant material.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT

[0021] The first balloon may be configured to be delivered to the treatment site in a pleatless configuration. In some embodiments, inflating the first balloon includes permitting ingress of blood into the first balloon.

[0022] Also included in the present disclosure is a method, including inserting a first medical device including a first balloon into a treatment site within a vasculature of a patient. In some embodiments, the first balloon contains a fluid. According to some embodiments, the method includes transitioning the first balloon from a tensioned state to an untensioned state such that an exterior surface of the first balloon contacts an interior surface of the treatment site. The method may include forming pressure waves inside the first balloon. In some embodiments, the method includes removing the first medical device from the treatment site. According to some embodiments, the method includes removing inserting a second medical device including a second balloon into the treatment site. The method may include inflating the second balloon such that an exterior surface of the second balloon causes increased dilation of the vasculature at the treatment site. In some embodiments, the method includes removing the second medical device from the treatment site.

[0023] According to some embodiments, transitioning the first balloon from the tensioned state to the untensioned state includes releasing a tension at a proximal portion of the first balloon. Releasing the tension at the proximal portion of the first balloon may include releasing a wire attached to the proximal portion of the first balloon. In some embodiments, releasing the tension at the proximal portion of the first balloon includes pushing on a wire attached to the proximal portion of the first balloon.

[0024] According to some embodiments, transitioning the first balloon from the tensioned state to the untensioned state includes releasing a tension at a distal portion of the first balloon. Releasing the tension at the distal portion of the first balloon may include releasing a wire attached to the distal portion of the first balloon. In some embodiments, releasing the tension at the distal portion of the first balloon includes pulling on a wire attached to the distal portion of the first balloon.

[0025] According to some embodiments, the method further includes transitioning the first balloon from the untensioned state to the tensioned state prior to removing the first medical device from the treatment site. Transitioning the first balloon from the untensioned state to the tensioned state may include applying a tension at a proximal portion of the first balloon. In some embodiments, applying the tension at the proximal portion of the first balloon includes pulling on a wire attached to the proximal portion of the first balloon.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT

[0026] According to some embodiments, transitioning the first balloon from the untensioned state to the tensioned state includes applying a tension at a distal portion of the first balloon. Applying the tension at the distal portion of the first balloon may include pushing on a wire attached to the distal portion of the first balloon.

[0027] Also included in the present disclosure is a method, including inserting a medical device including a first balloon and a second balloon proximal to the first balloon into a treatment site within a vasculature of a patient. In some embodiments, the first balloon is disposed adjacent to the treatment site. According to some embodiments, the method includes inflating the first balloon such that an exterior surface of the first balloon contacts an interior surface of the treatment site. The method may include forming pressure waves inside the first balloon. In some embodiments, the method includes inserting the medical device further into the vasculature such that the second balloon is adjacent to the treatment site. According to some embodiments, the method includes inflating the second balloon such that an exterior surface of the second balloon causes increased dilation of the vasculature at the treatment site. The method may include removing the medical device from the treatment site.

[0028] In some embodiments, inflating the first balloon includes transitioning the first balloon from a tensioned state to an untensioned state. According to some embodiments, transitioning the first balloon from the tensioned state to the untensioned state includes releasing a tension at a proximal portion of the first balloon. Releasing the tension at the proximal portion of the first balloon may include releasing a wire attached to the proximal portion of the first balloon. In some embodiments, releasing the tension at the proximal portion of the first balloon includes pushing on a wire attached to the proximal portion of the first balloon.

[0029] According to some embodiments, transitioning the first balloon from the tensioned state to the untensioned state includes releasing a tension at a distal portion of the first balloon. Releasing the tension at the distal portion of the first balloon may include releasing a wire attached to the distal portion of the first balloon. In some embodiments, releasing the tension at the distal portion of the first balloon includes pulling on a wire attached to the distal portion of the first balloon.

[0030] According to some embodiments, the method further includes transitioning the first balloon from the untensioned state to the tensioned state prior to removing the medical device from the treatment site.

[0031] Transitioning the first balloon from the untensioned state to the tensioned state may include applying a tension at a proximal portion of the first balloon. In some embodiments, applying the tension at the proximal portion of the first balloon includes pulling on a wirePCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT attached to the proximal portion of the first balloon. According to some embodiments, transitioning the first balloon from the untensioned state to the tensioned state includes applying a tension at a distal portion of the first balloon. Applying the tension at the distal portion of the first balloon may include pushing on a wire attached to the distal portion of the first balloon.

[0032] The foregoing, and other features and advantages of the invention, will be apparent from the following, more particular description of the preferred embodiments of the invention, the accompanying drawings, and the claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0033] 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.

[0034] FIG. 1 illustrates a diagrammatic view of an intravascular lithotripsy (IVL) system as it may appear inserted into a patient’s vasculature.

[0035] FIG. 2 is a diagram illustrating an IVL system.

[0036] FIG. 3 illustrates an embodiment of the IVL system of FIG. 2 as it may appear in a usecase scenario.

[0037] FIG. 4 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.

[0038] FIG. 5 illustrates a block diagram of the laser energy source system, such as the generator of FIG. 3, according to some examples.

[0039] FIG. 6A illustrates a cross-sectional view of a semi-compliant or non-compliant balloon, according to some embodiments.

[0040] FIG. 6B illustrates a cross-sectional view of the semi-compliant or non-compliant balloon of FIG. 6A as it unfolds, according to some embodiments.

[0041] FIG. 6C illustrates a cross-sectional view of the semi-compliant or non-compliant balloon of FIG. 6A as it may appear fully inflated.

[0042] FIG. 7A illustrates a cross-sectional view of a compliant balloon in an unexpanded state, according to some embodiments.

[0043] FIG. 7B illustrates a cross-sectional view of the compliant balloon of FIG. 7A as it may appear fully inflated.

[0044] FIG. 8 A illustrates a side view of a compliant balloon in an unexpanded state, accordingPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT to some examples.

[0045] FIG. 8B illustrates a side view of the compliant balloon of FIG. 8A as it may appear fully inflated.

[0046] FIG. 8C illustrates an additional side view of the compliant balloon of FIG. 8A as it may appear fully inflated.

[0047] FIG. 8D illustrates a third side view of the compliant balloon of FIG. 8A as it may appear fully inflated.

[0048] FIG. 9A illustrates a side view of a compliant balloon in an unexpanded state, according to some embodiments.

[0049] FIG. 9B illustrates a side view of the compliant balloon of FIG. 9A as it may appear fully inflated.

[0050] FIG. 10 illustrates a side view of a rotating optical fiber, according to some embodiments.

[0051] FIG. 11 illustrates a side view of an angled optical fiber, according to some embodiments.

[0052] FIG. 12 illustrates a side view of a combination of the rotating optical fiber of FIG. 10 and the angled optical fiber of FIG. 11, according to some embodiments.

[0053] FIG. 13 A illustrates a side view of a balloon including a blood flow lumen, according to some embodiments.

[0054] FIG. 13B illustrates a cross-sectional view of the balloon of FIG. 13 A.

[0055] FIG. 14A illustrates a side view of a balloon including features to permit blood flow, according to some embodiments.

[0056] FIG. 14B illustrates a cross-sectional view of the balloon of FIG. 14 A.

[0057] FIG. 15A illustrates a side view of another balloon including features to permit blood flow, according to some embodiments.

[0058] FIG. 15B illustrates a cross-sectional view of the balloon of FIG. 15 A.

[0059] FIG. 16 illustrates a side view of a medical device with multiple balloons, according to some embodiments.

[0060] FIG. 17A illustrates a side view of a balloon in a tensioned state, according to some embodiments.

[0061] FIG. 17B illustrates a side view of the balloon of FIG. 17A in an untensioned state, according to some embodiments.

[0062] FIG. 18A illustrates a side view of a balloon in a tensioned state, according to some embodiments.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT

[0063] FIG. 18B illustrates a side view of the balloon of FIG. 18A in an untensioned state, according to some embodiments.

[0064] FIG. 19A illustrates a side view of a balloon in a tensioned state, according to some embodiments.

[0065] FIG. 19B illustrates a side view of the balloon of FIG. 19A in an untensioned state, according to some embodiments.

[0066] FIG. 20A illustrates a side view of a balloon in a tensioned state, according to some embodiments.

[0067] FIG. 20B illustrates a side view of the balloon of FIG. 20A in an untensioned state, according to some embodiments.

[0068] FIG. 21 illustrates a side view of a spiral balloon, according to some embodiments.

[0069] FIG. 22 illustrates a flowchart depicting a method of treating a vessel using two balloons, according to some embodiments.

[0070] FIG. 23 illustrates a flowchart depicting another method of treating a vessel using two balloons, according to some embodiments.

[0071] FIG. 24 illustrates a flowchart depicting another method of treating a vessel using two balloons, according to some embodiments.DETAILED DESCRIPTION

[0072] During an intravascular lithotripsy (IVL) procedure, a clinician uses a catheter configured to break apart calcified-plaque lesions within a patient’s vasculature. Some such methods include the creation and rapid collapse of cavitation bubbles to create a shock wave which causes this calcification break-up.

[0073] 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.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT

[0074] 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.

[0075] During an intravascular lithotripsy (IVL) procedure, a clinician uses the formation and subsequent collapse of cavitation bubbles to generate high-energy pressure waves to disrupt calcified-plaque lesions within a patient’s vasculature. Some such IVL procedures include the generation of shock waves through the providing of laser energy, such as via an optical fiber.

[0076] 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.

[0077] FIG. 2 is a diagram illustrating an IVL system 10. As shown in FIG. 2, IVL system 10 may include at least an energy generator 210 and an elongated body 202 removably coupled to the energy generator 210, such as via an electrical connector 212. The elongated body 202 may include a medical device 12 positioned at a distal elongated body portion. 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.

[0078] While the term “elongated body” is used throughout the present specification, it is understood that an elongated body 202 may refer to a catheter, such as an IVL catheter. Additionally, while the connector 212 is described as an electrical connector 212 in the description of FIG. 2, it is understood that the connector 212 may also be an optical connector. In fact, in some examples, the IVL system 10 may not necessitate an electrical connector 212. 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 212 may not be necessary in all examples, an optical connector is necessary in order to provide the laser energy to the catheter.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT

[0079] As shown in FIG. 2, the medical device 12 may include a fluid-inflatable interventional balloon 102 and a pressure wave emitter positioned within the balloon 102. The pressure wave emitter may include one or more individual emitter units. For instance, the interventional balloon 102, or a distal elongated body portion passing therethrough, may define a central longitudinal axis 208, and emitter units may be distributed longitudinally along the central longitudinal axis 208.

[0080] Each emitter unit is configured to receive energy from the energy generator 210 and use the received energy to generate and transmit high-energy pressure waves through the balloon 102 and across a treatment site. As detailed further below, the energy generator 210 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 a cavitation bubble within the fluid inside the balloon 102, propagating one or more high- energy pressure waves radially outward through the balloon 102 and the calcified lesion 50.

[0081] 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, 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) signal from the generator 210, such as via one or more optical fibers, and direct the optical signal to trigger the initial cavitation. Additionally, one or more emitters can include an electrical-based emitter configured to receive electrical energy from the generator 210, such as via one or more conductive wires, and generate a spark between a pair of electrodes, thereby triggering the initial cavitation.

[0082] According to some examples, a cooling mechanism functions in tandem with the energy generator 210. However, flashlamp systems may provide energy to the optical fibers 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.

[0083] FIG. 3 illustrates an embodiment of the IVL system 10 of FIG. 2 as it may appear in use. A medical post may be provided to facilitate movement of the IVL system 10 between rooms as necessary. A power supply 302 may be situated near the base of the medical post, coupled to a power cord 308 for receiving wall power or power from a generator 210, as well as an umbilicus for electrically coupling to a console 304. As shown in FIG. 3, the console 304 allows a user, such as a clinician, to operate the IVL system 10. The elongated body 202 may be coupled to the console 304 via a power cable for receiving energy from the power supplyPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT302 to transmit energy to the emitters within the IVL balloon 102. A separate line dedicated to the inflation of the IVL balloon 102 may also be present.

[0084] According to some examples, a detection line 306 is present. The detection line 306 may offer a few methods of providing feedback about the integrity of the individual components within the IVL balloon 102. For instance, a safety pressure sensor (perhaps the pressure sensor 422 as seen in FIG. 4) may be provided. If a sudden pressure drop is detected, a failure may have occurred, such as a rupture of the IVL balloon 102. This suggests to the clinician that the procedure should be halted, and the IVL balloon 102 should be retrieved immediately and safely from the patient’s vasculature. According to some examples, once a pressure sensor in the IVL balloon 102 detects a balloon 102 rupture, energy emission through the elongated body 202 may be halted immediately. It is understood that the term “halted” may be used to issue an error code to the operator for a manual shutdown or an auto-system shutoff.

[0085] Additionally, the pressure sensor may be present anywhere within the pressure pathway, wherein the pressure pathway defines a path beginning at the generator 210 and ending at the balloon 102. In some examples, the pressure sensor may be within the generator 210. According to some examples, the pressure sensor may be within a hub 214, which is the intermediary component connecting the elongated body 202 to the generator 210 (in examples including a separate generator 210). The pressure sensor may be present within the elongated body 202. In some examples, as described in the preceding paragraph, the IVL balloon 102. The pressure sensor may be present outside of these distinct components (generator 210, hub 214, elongated body 202) but within the pressure pathway.

[0086] 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.

[0087] Additionally, a fiber interrogation mechanism may be present. According to some examples, the purpose of the fiber interrogation mechanism is to sense or detect if the optical fiber, or at least one of the optical fibers, has broken, or in other ways become disconnected. This may be achieved by reflecting at least a portion of the energy back down the optical fiber once a pulse has been emitted, and any obstruction of this return pulse would indicate to thePCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT clinician that something has gone awry, and the IVL balloon 102 should be retrieved, and the issue fixed.

[0088] FIG. 4 illustrates a perspective view of the IVL balloon 204 and an inset view illustrating a position for the distal fiber end of an optical fiber 404. In this example, and the examples following, any present optical fibers 404 act as pressure wave emitters 402. According to the example of FIG. 4, 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 404. While not shown in the figures, the optical fiber 404 may include a toe or blunt feature on its terminal portion to prevent accidental perforation of the balloon 102 by the optical fiber 404. It is understood that such a toe or blunt feature would not impede the passage of laser energy from the distal fiber end.

[0089] FIG. 5 illustrates a 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.

[0090] 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 lamp 514 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.

[0091] 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.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCTThe 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 above, 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.

[0092] Traditional IVL makes use of semi -compliant or non-compliant balloons. These semi- compliant or non-compliant balloons present a number of complications due to the manner in which they must be folded in order to achieve a crossing profile suitable for insertion into the vessels of a patient. For example, semi-compliant or non-compliant balloons cannot be sized for tapered vessels, as this would cause the balloon to either be sized too small for the larger diameter portion of the vessel, or sized too large such that the balloon cannot expand to its full size, causing voids in the treatment of the smaller diameter portions of the vessel. Additionally, after being inflated once, it is difficult to rewrap a semi-compliant or non-compliant balloon.

[0093] FIG. 6A illustrates a cross-sectional view of a semi-compliant or non-compliant balloon 602, according to some embodiments. In this illustration, the semi-compliant or non-compliant balloon 602 is shown in a folded configuration. Within the semi-compliant or non-compliant balloon 602 is shown the elongated body 202 along with the optical fiber 404. In such a folded configuration, the semi-compliant or non-compliant balloon 602 would fold down in such a manner as to ensure there is still room for the elongated body 202 and optical fiber 404, while trying to maintain a minimal cross-profile for insertion into the vessel of a patient.

[0094] FIG. 6B illustrates a cross-sectional view of the semi-compliant or non-compliant balloon 602 of FIG. 6A as it unfolds, according to some embodiments. Still shown near the center of the semi-compliant or non-compliant balloon 602 are the elongated body 202 and the optical fiber 404. As inflation fluid is injected into the semi-compliant or non-compliant balloon 602, it begins to expand, and the areas of higher stress (areas where the semi-compliant or non-compliant balloon 602 was pleated) begin to appear as areas where the semi-compliant or non-compliant balloon 602 is no longer perfectly circular in cross-section.

[0095] FIG. 6C illustrates a cross-sectional view of the semi-compliant or non-compliantPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT balloon 602 of FIG. 6A as it may appear fully inflated. Still shown near the center of the semi- compliant or non-compliant balloon 602 are the elongated body 202 and the optical fiber 404. As shown in FIG. 6C, the areas of higher stress now indicate an inward bias on the surface of the semi-compliant or non-compliant balloon 602. These points of bias create small treatment voids where the semi-compliant or non-compliant balloon 602 does not make contact with the vessel of the patient (or treatment site, such as a calcified lesion). This may lead to undertreatment of the area, or, in some cases, non-treatment of the area.

[0096] Additionally, it is understood that, while FIGS. 6A, 6B, and 6C each show three “pleats,” “folds,” and thereby areas of higher stress, any number of these features may be used as desired to create a set folded diameter and expanded diameter to facilitate passage through the vessel of a patient.

[0097] FIG. 7A illustrates a cross-sectional view of a compliant balloon 702 in an unexpanded state, according to some embodiments. Also shown in FIG. 7A are the elongated body 202 and the optical fiber 404. The compliant balloon 702 is shown tightly hugging both the elongated body 202 and the optical fiber 404, thereby minimizing the crossing profile of the device as a whole. Stated another way, in some embodiments, the balloon 702 is pleatless when in its unexpanded state.

[0098] FIG. 7B illustrates a cross-sectional view of the compliant balloon 702 of FIG. 7A as it may appear fully inflated. Still shown near the center of the compliant balloon 702 are the elongated body 202 and the optical fiber 404. Because of the elastic nature of compliant balloons, once injected with an inflation fluid, the compliant balloon 702 would achieve nearperfect, or perfect, restoration to its circumferential shape (outside of external forces, as will be discussed in FIGS. 8C and 8D below).

[0099] Benefits of using a compliant balloon 702 include the fact that there are no folds when the compliant balloon 702 is in an uninflated state. This means that there is less risk of damaging the optical fiber, and there is no need to rewrap the compliant balloon 702 after it has been inflated once. Compliant balloons are more flexible and trackable than semi- compliant or non-compliant balloons. Compliant balloons also require less material, and thus the crossing profile of the catheter is smaller in comparison to a catheter using a semi-compliant or non-compliant balloon.

[0100] Additionally, compliant balloons have a greater ability to conform to the vessel for better apposition (as shown in FIG. 8C below), as well as the ability to treat variable vessel diameters (as shown in FIG. 8D below). Furthermore, a single compliant balloon may be able to cover all vessel sizes due to the expandable nature of compliant balloons. An operator wouldPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT not need multiple balloon diameters for different locations of treatments, as a compliant balloon may be able to serve as a “one-size-fits-all” balloon.

[0101] FIG. 8A illustrates a side view of a compliant balloon 702 in an unexpanded state, according to some examples. However, it may be more accurate to say that compliant balloon 702 is partially expanded in FIG. 8A in order to distinguish between the compliant balloon 702, the elongated body 202, and the optical fiber 404, as in a truly unexpanded state the compliant balloon 702 may more tightly hug these components. In any case, when the compliant balloon 702 is partially expanded or unexpanded, it has a smaller crossing profile, facilitating tracking of the catheter through the vessel 30 of the patient.

[0102] FIG. 8B illustrates a side view of the compliant balloon 702 of FIG. 8A as it may appear fully inflated. Still shown in FIG. 8B are the elongated body 202 and the optical fiber 404. Because a compliant balloon 702 will expand to fill the volume of that in which it is placed, the compliant balloon 702 will make full circumferential contact with the vessel 30 of the patient (in this figure, a healthy vessel). This full circumferential contact facilitates full treatment of the area.

[0103] FIG. 8C illustrates an additional side view of the compliant balloon 702 of FIG. 8 A as it may appear fully inflated. Still shown in FIG. 8C are the elongated body 202 and the optical fiber 404. In this figure, the vessel 30 is unhealthy and includes calcified lesions 50. In order to increase the efficacy of an intravascular lithotripsy treatment, direct contact between the wall of the balloon and the calcification is desired. In this figure, the compliant balloon 702 will expand until at least some portions of the compliant balloon 702 are in contact with the calcified lesions 50 about the wall of the vessel 30, thus facilitating full treatment in this area. A compliant balloon 702 may make contact with a greater amount of the wall of the vessel 30 than a similar length semi-compliant or non-compliant balloon.

[0104] FIG. 8D illustrates a third side view of the compliant balloon 702 of FIG. 8 A as it may appear fully inflated. Still shown in FIG. 8D are the elongated body 202 and the optical fiber 404. In this figure, the vessel 30 is tapered, meaning there are regions of smaller diameter and larger diameter. Because of the elastic nature of compliant balloons, compliant balloon 702 may expand to make full contact with the wall of the vessel 30, both in the smaller and larger diameter regions simultaneously, thus facilitating full treatment in this area.

[0105] FIG. 9A illustrates a side view of a compliant balloon 702 in an unexpanded state, according to some embodiments. Once again, similar to FIG. 8A, it may be more accurate to say that the compliant balloon 702 is in a partially expanded state in order to distinguish between the compliant balloon 702, the elongated body 202, and the optical fiber 404, as in aPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT truly unexpanded state the compliant balloon 702 may more tightly hug these components. In this figure, the distal tail end of the compliant balloon 702 is secured within the balloon body, rather than extending into a tapered tip, as is conventional with semi-compliant or non- compliant balloons, and shown in the preceding figures as a possible configuration for this distal tail end.

[0106] In either case, the elongated body 202 may be embedded within the balloon as shown in FIG. 9A, or extend past the distal tail end of the compliant balloon 702 (not shown) by simply extending the elongated body 202 further, or tucking the distal tail end of the compliant balloon 702 further back.

[0107] FIG. 9B illustrates a side view of the compliant balloon 702 of FIG. 9A as it may appear fully inflated. Still shown in FIG. 9B are the elongated body 202 and the optical fiber 404. In this inflated state, the distal end of the compliant balloon 702 shows a bull nose 902. Such a bull nose 902 may protect the vessel from any contact with the elongated body 202 or optical fiber 404 in the distal direction.

[0108] The compliant balloon 702 also permits the bull nose 902 to track and be inflated, allowing energy delivery to occur in the distal tip of the balloon. This may facilitate the expansion of the vessel in the distal direction for the purposes of catheter delivery and / or treatment of the entire lesion.

[0109] FIG. 10 illustrates a side view of a rotating optical fiber 404 within a compliant balloon 702, according to some embodiments. Permitting the optical fiber 404 to rotate, in combination with various embodiments disclosed herein, such as the bull nose 902, may allow for delivery of energy both within and outside of the compliant balloon 702, while also permitting radial and circumferential energy delivery.

[0110] FIG. 11 illustrates a side view of an angled optical fiber 404, according to some embodiments. Shock waves perpetrated by an angled optical fiber 404 may be projected perpendicular to the angle of termination of such an optical fiber 404. In FIG. 11, this angle appears as approximately ninety degrees, which would result in a near-perfect or perfectly distal traversal of shock wave energy.[OHl] It is understood, however, that a ninety-degree angle is by way of example only, and any other possible angle for the distal end of the optical fiber 404 may likewise be realized, thus allowing the operator control of the direction of traversal of the shock waves. In some embodiments, the operator may be able to control the angle of the distal end of the optical fiber during a procedure, thus granting even further control over the shock wave transmissions.

[0112] In the case of a semi -compliant or non-compliant balloon, such an angled distal end ofPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT the optical fiber may cause friction and general wear and tear on the balloon while the balloon is in a non-expanded or less than fully expanded state. Through the use of a compliant balloon 702, the inherent elasticity of the material selected may prevent and / or reduce a risk of any such wear and tear and permit the optical fiber 404 to achieve otherwise perilous angles of transmission.

[0113] FIG. 12 illustrates a side view of a combination of the rotating optical fiber 404b of FIG. 10 and the angled optical fiber 404a of FIG. 11, according to some embodiments. In this embodiment, even further control of the angle of transmission may be actuated for an operator. The angled optical fiber 404a, now present alongside a rotating optical fiber 404b, may likewise be rotated about the central axis of the catheter. This may permit a full sphere of coverage, as the angle of the optical fiber may now also be spun three hundred and sixty degrees about treatment area, ensuring no calcification goes untreated.

[0114] As disclosed above with respect to FIG. 11, the ninety-degree angle is by way of example only, and any other possible angle for the distal end of the optical fiber 404a may likewise be realized, thus allowing the operator control of the direction of traversal of the shock waves. In some embodiments, the operator may be able to control the angle of the distal end of the optical fiber during a procedure, thus granting even further control over the shock wave transmissions.

[0115] Additionally, as disclosed in FIG. 10 above, permitting the optical fiber 404b to rotate, in combination with various embodiments disclosed herein, such as the bull nose 902, may allow for delivery of energy both within and outside of the compliant balloon 702, while also permitting radial and circumferential energy delivery.

[0116] Also included in the present disclosure are methods by which blood may flow through and / or past a balloon while it is inflated within a vessel in order to deliver treatment. During treatments where a balloon is inflated in a vessel, the balloon may become an occluding member, preventing blood from flowing through the vessel and thus limiting the amount of time treatment may be delivered while not causing undue harm to the vessel do to prolonged occlusion. By permitting blood to flow through and / or around the balloon while it is inflated, the balloon may be able to be inflated for a prolonged period of time, thus increasing the amount of time a treatment may be safely applied.

[0117] Additionally, by changing the profile of the balloon on the outside, or by having a lumen pass through the balloon, the amount of time needed to inflate the balloon may decrease, due to the smaller volume within the balloon. This may mean that the time needed to locate a treatment location to the time of actually providing the treatment may likewise decrease, duePCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT to this inflation step being shorter.

[0118] FIG. 13A illustrates a side view of a balloon 1302 including a blood flow lumen 1304, and FIG. 13B illustrates a cross-sectional view thereof. Still shown in FIGS. 13A and 13B are the elongated body 202 and the optical fiber 404. As shown in FIG. 13B, the balloon 1302 is not making contact with the vessel 30, but this is only to differentiate between the two components for explanation purposes, and it is understood that in practice the balloon 1302 would make contact with the vessel 30 for treatment.

[0119] The embodiment shown in FIGS. 13A and 13B may be suitable for application over a range of balloon 1302 compliances, including fully compliant, semi-compliant, and non- compliant. The blood flow lumen 1304 may be a lumen extending through the balloon 1302, including an opening near both the proximal and distal ends of the balloon 1302. When the balloon 1302 is in an inflated, or expanded, state, blood may be able to flow through the blood flow lumen 1304, thus permitting treatment of the location without fully occluding the vessel.

[0120] Additionally, while the blood flow lumen 1304 is shown above the elongated body 202 in FIGS. 13A and 13B, this is understood to be by way of example only, and the blood flow lumen 1304 may rotate about the central axis of the elongated body 202 as the elongated body 202 is turned.

[0121] FIG. 14A illustrates a side view of a balloon 1402 including features to permit blood flow, and FIG. 14B illustrates a cross-sectional view thereof. Still shown in FIGS. 14A and 14B are the elongated body 202 and the optical fiber 404. In this embodiment, constraining features 1404 are included. These constraining features 1404 may be located on an exterior surface of the balloon 1402, and prevent the balloon 1402 from expanding to the wall of the vessel 30 in these locations. While not shown in FIGS. 14A and 14B, the constraining features 1404 may also be present on an interior surface of the balloon 1402. Through prevention of full contact between the balloon 1402 and the vessel 30, blood may flow about the balloon 1402 while it is fully expanded, thus preventing full occlusion of the vessel 30 during treatment. The constraining features may be made of nitinol, or any other material that is safe for intracorporeal use.

[0122] These constraining features 1404 may be utilized with a balloon of any compliance, including fully compliant, semi-compliant, and non-compliant. However, in the case of semi- compliant and non-compliant balloons, it is possible that the constraining features 1404 may not be needed at all. As mentioned above with respect to semi-compliant and non-compliant balloons, the manner in which such balloons must be folded may cause “pleats” to form on the exterior surface of the balloon. This property of semi-compliant or non-compliant balloons mayPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT be intentionally amplified in order to cause locations for blood to flow about the expanded balloon.

[0123] Additionally, while five constraining features are illustrated in FIGS. 14A and 14B, it is understood that this number of constraining features 1404 is by way of example only and that any number of constraining features 1404 (or locations permissive of blood flow about the balloon in the absence of constraining features as described in the preceding paragraph) may be included in the device.

[0124] FIG. 15A illustrates a side view of another balloon 1502 including features to permit blood flow, and FIG. 15B illustrates a cross-sectional view thereof. Still shown in FIGS. 15 A and 15B are the elongated body 202 and the optical fiber 404. As shown in FIG. 15B, the balloon 1502 is not making contact with the vessel 30, but this is only to differentiate between the two components for explanation purposes, and it is understood that in practice the balloon 1502 would make contact with the vessel 30 for treatment.

[0125] Similar to FIGS. 14A and 14B above, the feature may be a constraining feature 1504. This constraining feature 1504 may be located on an exterior surface of the balloon 1502, and prevent the balloon 1502 from expanding to the wall of the vessel 30 in this location. While not shown in FIGS. 15A and 15B, the constraining feature 1504 may also be present on an interior surface of the balloon 1502. Through prevention of full contact between the balloon 1502 and the vessel 30 in this location, blood may flow about the balloon 1502 while it is fully expanded, thus preventing full occlusion of the vessel 30 during treatment.

[0126] While the constraining feature 1504 is shown above the elongated body 202 in FIGS. 15A and 15B, this is understood to be by way of example only, and the constraining feature 1504 may rotate about the central axis of the elongated body 202 as the elongated body 202 is turned.

[0127] The constraining feature 1504 may be utilized with a balloon of any compliance, including fully compliant, semi-compliant, and non-compliant. However, in the case of semi- compliant and non-compliant balloons, as detailed above, it is possible that the constraining feature 1504 may not be needed at all. Again, as mentioned above with respect to semi- compliant and non-compliant balloons, the manner in which such balloons must be folded may cause “pleats” to form on the exterior surface of the balloon. This property of semi-compliant or non-compliant balloons may be intentionally amplified in order to cause locations for blood to flow about the expanded balloon.

[0128] In additional or alternative embodiments, any combination of perfusion embodiments from FIGS. 13A, 13B, 14A, 14B, 15A, and 15B may be used in conjunction with one another,PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT or with any other embodiment as explored throughout the present disclosure.

[0129] FIG. 16 illustrates a side view of a medical device with multiple balloons, according to some embodiments. As shown, located on the elongated body 202, a first balloon 1602 may be present distal to a second balloon 1604. Inside the first balloon, optical fiber 404 is shown.

[0130] The first balloon 1602 and the second balloon 1604 may be made from the same material. In some embodiments, the first balloon 1602 is compliant, and the second balloon 1604 is semi-compliant or non-compliant. The first balloon 1602 and the second balloon 1604 may share an inflation lumen. In additional or alternative embodiments, the first balloon 1602 and the second balloon 1604 each include their own, distinct, inflation lumen.

[0131] In any embodiment, the first balloon 1602 may be provided to a target treatment area, such as near or adjacent a calcified lesion in a vasculature of a patient. The first balloon 1602 may then be inflated, such as via an inflation lumen. In embodiments where the first balloon 1602 is compliant, the first balloon 1602 may include any or all of the benefits as shown and illustrated in the preceding figures and paragraphs pertaining to compliant balloons. Once the first balloon 1602 is inflated, energy flowing through the optical fiber 404 may provide pressure waves to fracture the calcific lesion.

[0132] After pressure waves have been delivered, the first balloon 1602 may be deflated, and the medical device may be inserted further into the vasculature of the patient, such that the second balloon 1604 is near or adjacent the now fractured calcific lesion. Once in position, the second balloon 1604 may be inflated such as to further dilate, or post-dilate, the vessel. In embodiments where the second balloon 1604 is semi-compliant or non-compliant, the second balloon 1604 may expand to a diameter that is greater than the natural diameter of the vessel being treated. This may help further open the vessel with low risk of damage due to the inherent elasticity of vessel walls.

[0133] In FIGS. 17A-20B, reference is made to a wire (wire 1706, 1802, 1906, and 2006). The term “wire” is intended to mean any structure that may run alongside the elongated body 202 and attach to the balloon to effect an external force on the balloon, such as a thread.

[0134] FIG. 17A illustrates a side view of a balloon 1702 in a tensioned state 1708, and FIG. 17B illustrates the balloon 1702 in an untensioned state 1710, according to some embodiments. The balloon 1702 may be located on an elongated body 202, and optical fiber 404 may also be located along the elongated body 202 within the balloon 1702. The balloon 1702 may be compliant.

[0135] The balloon 1702 may be primed with a fluid 1704 that causes the balloon 1702 to inflate outside of an external force. Stated another way, the balloon 1702 may include a naturalPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT state of expansion when provided with a specific quantity of fluid, and the primed fluid may be of enough quantity to cause such a natural state of expansion. The natural state of expansion may be selected based on the needs of the target area to be treated, and in turn, the quantity of primed fluid may be determined. Thus, the natural state of expansion may include a partially inflated balloon, and / or a fully inflated balloon.

[0136] A wire 1706 may be provided and attached to a proximal portion of the balloon 1702. The wire 1706 may be pulled proximally in order to exert a force on the balloon 1702, and effectively decrease the diameter of the balloon 1702 through increasing the length of the balloon 1702 (e.g., placing the balloon in a tensioned state 1708). While not equivalent to an uninflated state, the decreased diameter state of the balloon 1702 may facilitate passage through a vasculature to a target treatment area.

[0137] Once the medical device is delivered to the target treatment area, the wire 1706 may either be released, allowing the balloon 1702 to return to its natural state of expansion absent outside force, or the wire 1706 may be pushed distally, forcing the balloon 1702 into a state of shortened length and thus increased diameter (e.g., placing the balloon in an untensioned state 1710). Once the treatment is completed, the wire 1706 may once again be pulled to decrease the effective diameter of the balloon for removal from the vasculature.

[0138] FIG. 18A illustrates a side view of a balloon 1702 in a tensioned state 1708, and FIG. 18B illustrates a side view of the balloon 1702 in an untensioned state 1710, according to some embodiments. The balloon 1702 may be located on an elongated body 202, and optical fiber 404 may also be located along the elongated body 202 within the balloon 1702. The balloon 1702 may be compliant.

[0139] The balloon 1702 may be primed with a fluid 1704 that causes the balloon 1702 to inflate outside of an external force. Stated another way, the balloon 1702 may include a natural state of expansion when provided with a specific quantity of fluid, and the primed fluid may be of enough quantity to cause such a natural state of expansion. The natural state of expansion may be selected based on the needs of the target area to be treated, and in turn, the quantity of primed fluid. Thus, the natural state of expansion may include a partially inflated balloon, and / or a fully inflated balloon.

[0140] A wire 1802 may be provided and attached to a distal portion of the balloon 1702. The wire 1802 may be pushed distally in order to exert a force on the balloon 1702, and effectively decrease the diameter of the balloon 1702 through increasing the length of the balloon 1702 (e.g., placing the balloon in a tensioned state 1708). While not equivalent to an uninflated state, the decreased diameter state of the balloon 1702 may facilitate passage through a vasculaturePCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT to a target treatment area.

[0141] Once the medical device is delivered to the target treatment area, the wire 1802 may either be released, allowing the balloon 1702 to return to its natural state of expansion absent outside force, or the wire 1802 may be pulled proximally, forcing the balloon 1702 into a state of shortened length and thus increased diameter (e.g., placing the balloon in an untensioned state 1710). Once the treatment is completed, the wire 1802 may once again be pushed to decrease the effective diameter of the balloon for removal from the vasculature.

[0142] FIG. 19A illustrates a side view of a balloon 1902 in a tensioned state, and FIG. 19B illustrates a side view of the balloon 1902 in an untensioned state according to some embodiments. The balloon 1902 may be located on an elongated body 202, and optical fiber 404 may also be located along the elongated body 202 within the balloon 1902. The balloon 1902 may be compliant.

[0143] The balloon 1902 may be coupled to the elongated body 202 at a distal end, and at least partially, or completely, uncoupled from the elongated body 202 at a proximal end. This partial, or complete, disconnect between the balloon 1902 and the elongated body 202 at a proximal end may permit the ingress of blood 1904 in the vasculature of the patient into the balloon 1902. In this way, blood 1904 may be used to inflate, or expand, the balloon 1902, eliminating the need for additional fluid, such as the primed fluid balloons of FIGS. 17A-18B, or inflation lumens.

[0144] A wire 1906 may be provided and attached to a proximal portion of the balloon 1902. The wire 1906 may be pulled proximally in order to exert a force on the balloon 1902, and prevent the blood 1904 from fully expanding the balloon 1902. While not equivalent to an uninflated state, the decreased diameter state of the balloon 1902 may facilitate passage through a vasculature to a target treatment area.

[0145] Once the medical device is delivered to the target treatment area, the wire 1906 may be released, allowing blood to fully ingress the balloon 1902 and effectively inflate the balloon 1902 until contact is made with the vessel walls (or calcific lesions about the vessel walls). In additional or alternative embodiments, the wire may be pushed in order to expand and permit the ingress of blood. Once the treatment is completed, the wire 1906 may once again be pulled to decrease the effective diameter of the balloon 1902 for removal from the vasculature.

[0146] FIG. 20A illustrates a side view of a balloon 2002 in a tensioned state and FIG. 20B illustrates a side view of the balloon 2002 in an untensioned state, according to some embodiments. The balloon 2002 may be located on an elongated body 202, and optical fiber 404 may also be located along the elongated body 202 within the balloon 2002. The balloonPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT2002 may be compliant.

[0147] The balloon 2002 may be coupled to the elongated body 202 at a proximal end, and at least partially, or completely, uncoupled from the elongated body 202 at a distal end. This partial, or complete, disconnect between the balloon 2002 and the elongated body 202 at a distal end may permit the ingress of blood 2004 in the vasculature of the patient into the balloon 2002. In this way, blood 2004 may be used to inflate, or expand, the balloon 2002, eliminating the need for additional fluid, such as the primed fluid balloons of FIGS. 17A-18B, or inflation lumens.

[0148] A wire 2006 may be provided and attached to a distal portion of the balloon 2002. The wire 2006 may be pushed proximally in order to exert a force on the balloon 2002, and prevent the blood 2004 from fully expanding the balloon 2002. While not equivalent to an uninflated state, the decreased diameter state of the balloon 2002 may facilitate passage through a vasculature to a target treatment area.

[0149] Once the medical device is delivered to the target treatment area, the wire 2006 may be released, allowing blood to fully ingress the balloon 2002 and effectively inflate the balloon 2002 until contact is made with the vessel walls (or calcific lesions about the vessel walls). Once the treatment is completed, the wire 2006 may once again be pushed to decrease the effective diameter of the balloon 2002 for removal from the vasculature.

[0150] The medical devices of FIGS. 19A-20B may be selected based on the direction of blood flow through the vessel to be treated. For example, if blood is flowing with the direction of insertion of the medical device, the medical device of FIGS. 19A and 19B may better facilitate the ingress of blood 1904 into the balloon 1902. If blood is flowing contra to the direction of insertion of the medical device, the medical device of FIGS. 20A and 20B may better facilitate the ingress of blood 2004 into the balloon 2002.

[0151] FIG. 21 illustrates a side view of a spiral balloon 2102, according to some embodiments. The balloon 2102 may be located on an elongated body 202, and optical fiber 2104 may also be located along the elongated body 202 within the balloon 2102. The balloon 2102 may be compliant. In this embodiment, the flexibility of an optical fiber 2104 permits the optical fiber 2104 to spiral about the elongated body 202 along with the balloon 2102. While called a “balloon” throughout this disclosure, the spiral balloon 2102 may also be considered an elastic tube.

[0152] The balloon 2102 may be wound, or “wrapped” around the elongated body 202, while the optical fiber 2104, within the balloon 2102, winds, or wraps, around the elongated body 202 at or substantially at the same rate of rotation per length as the balloon 2102. As illustratedPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT in FIG. 21, the balloon 2102 and the optical fiber 2104 wrap three hundred and sixty degrees around the elongated body 202. In additional or alternative embodiments, the balloon 2102 and the optical fiber 2104 may wrap around the elongated body 202 multiple times.

[0153] Benefits of a spiral balloon 2102 may include creating additional space while the balloon is in an inflated state, and / or directing energy based on what side of the elongated body 202 a terminal end of the optical fiber 2104 is located (i.e., a resultant pressure wave created via delivered energy through the optical fiber 2104 will be more efficacious on the side of the elongated member that the terminal end of the optical fiber 2104 is located, as the pressure wave would need to travel further through the balloon 2102 in order to reach locations not in the immediate vicinity and / or adjacent of the terminal end of the optical fiber 2104, diminishing the force of the pressure waves in these further away locations, effectively directing the energy based on the rotational position of the balloon 2102 at the time energy is delivered through the optical fiber 2104).

[0154] FIG. 22 illustrates a flowchart depicting a method of treating a vessel using two balloons, according to some embodiments. In some embodiments, the method includes inserting a first medical device into a target treatment site (at step 2200). The medical device may be any of the single balloon medical devices as illustrated and disclosed in the preceding figures and paragraphs. The target treatment site may be within a vasculature of a patient.

[0155] According to some embodiments, the method includes inflating a first balloon (at step 2202). The first balloon may be inflated such that an exterior surface of the first balloon makes contact with an interior surface of the target treatment site, and / or any present calcific lesions within the target treatment site. The first balloon may be compliant. The first balloon may be delivered to the target treatment site in a pleatless configuration. In some embodiments, inflating the first balloon includes permitting ingress of blood into the first balloon.

[0156] The method may include forming pressure waves (at step 2204). The pressure waves may be induced through an optical fiber(s). The pressure waves may be strong enough to travel through any present inflation fluid (or blood) and fracture any present calcific lesion in the target treatment site.

[0157] In some embodiments, the method includes removing the first medical device (at step 2206). The first balloon may be deflated, or transitioned to an unexpanded state, prior to removal of the first medical device.

[0158] According to some embodiments, the method includes inserting a second medical device into the target treatment site (at step 2208). The method may include inflating a second balloon (at step 2210). The second balloon may be inflated such that an exterior surface of thePCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT second balloon makes contact with an interior surface of the target treatment site, and / or any present fractured calcific lesions within the target treatment site. The second balloon may have a maximum inflation diameter that is greater than the natural diameter of the vessel at the target treatment site, and inflation of the second balloon may cause further dilation, or post-dilation of the vessel. The second balloon may be semi-compliant or non-compliant.

[0159] In some embodiments, the method includes removing the second medical device (at step 2212). The second balloon may be deflated, or otherwise transitioned to an unexpanded state, prior to removal of the second medical device.

[0160] FIG. 23 illustrates a flowchart depicting another method of treating a vessel using two balloons, according to some embodiments. In some embodiments, the method includes inserting a first medical device into a target treatment site (at step 2300). The medical device may be any of the single balloon medical devices as illustrated and disclosed in FIGS. 17A- 20B above. The target treatment site may be within a vasculature of a patient.

[0161] According to some embodiments, the method includes transitioning a first balloon from a tensioned state to an untensioned state (at step 2302). As described above with respect to FIGS. 17A-18B, the first balloon may be primed with fluid which causes the first balloon to have a natural diameter of expansion outside an external force. A force may be exerted on the balloon, either proximally or distally, in order to prevent the first balloon from achieving its natural diameter of expansion during delivery to the target treatment site. Once the first balloon has been delivered to the target treatment site, the force may be withdrawn, causing the first balloon to enter its rest state (e.g., untensioned state) including the natural diameter of expansion, or an opposing force may be presented, achieving an increased diameter of the first balloon.

[0162] The first balloon may be inflated such that an exterior surface of the first balloon makes contact with an interior surface of the target treatment site, and / or any present calcific lesions within the target treatment site. The first balloon may be compliant. The first balloon may be delivered to the target treatment site in a pleatless configuration.

[0163] The method may include forming pressure waves (at step 2304). The pressure waves may be induced through an optical fiber(s). The pressure waves may be strong enough to travel through the primed fluid and fracture any present calcific lesion in the target treatment site.

[0164] In some embodiments, the method includes removing the first medical device (at step 2306). The first balloon may be transitioned to an tensioned state, prior to removal of the first medical device. This transition to the tensioned state may include reapplying the external force, either proximally or distally, to the first balloon.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT

[0165] According to some embodiments, the method includes inserting a second medical device into the target treatment site (at step 2308). The method may include inflating a second balloon (at step 2310). The second balloon may be inflated such that an exterior surface of the second balloon makes contact with an interior surface of the target treatment site, and / or any present fractured calcific lesions within the target treatment site. The second balloon may have a maximum inflation diameter that is greater than the natural diameter of the vessel at the target treatment site, and inflation of the second balloon may cause further dilation, or post-dilation of the vessel. The second balloon may be semi-compliant or non-compliant.

[0166] In some embodiments, the method includes removing the second medical device (at step 2312). The second balloon may be deflated, or otherwise transitioned to an unexpanded state, prior to removal of the second medical device.

[0167] FIG. 24 illustrates a flowchart depicting another method of treating a vessel using two balloons, according to some embodiments. In some embodiments, the method includes inserting a medical device into a target treatment site (at step 2400). The medical device may be the two balloon medical device as illustrated and disclosed in FIG. 16 above. The target treatment site may be within a vasculature of a patient.

[0168] According to some embodiments, the method includes inflating a first balloon (at step 2402). The first balloon may be any of the balloons as described in above with respect to single balloon medical devices. The first balloon may be primed with fluid which causes the first balloon to have a natural diameter of expansion outside an external force. A force may be exerted on the balloon, either proximally or distally, in order to prevent the first balloon from achieving its natural diameter of expansion during delivery to the target treatment site. Once the first balloon has been delivered to the target treatment site, the force may be withdrawn, causing the first balloon to enter its rest state (e.g., untensioned state) including the natural diameter of expansion, or an opposing force may be presented, achieving an increased diameter of the first balloon.

[0169] The first balloon may be inflated such that an exterior surface of the first balloon makes contact with an interior surface of the target treatment site, and / or any present calcific lesions within the target treatment site. The first balloon may be compliant. The first balloon may be delivered to the target treatment site in a pleatless configuration. In some embodiments, inflating the first balloon includes permitting ingress of blood into the first balloon.

[0170] The method may include forming pressure waves (at step 2404). The pressure waves may be induced through an optical fiber(s). The pressure waves may be strong enough to travel through any present inflation fluid (or blood) and fracture any present calcific lesion in thePCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT target treatment site.

[0171] In some embodiments, the method includes inserting the medical device further into a vasculature of a patient (at step 2406). The first balloon may move past the target treatment segment until a second balloon is located near or adjacent to the treatment segment.

[0172] According to some embodiments, the method includes inflating a second balloon (at step 2408). The second balloon may be inflated such that an exterior surface of the second balloon makes contact with an interior surface of the target treatment site, and / or any present fractured calcific lesions within the target treatment site. The second balloon may have a maximum inflation diameter that is greater than the natural diameter of the vessel at the target treatment site, and inflation of the second balloon may cause further dilation, or post-dilation of the vessel. The second balloon may be semi-compliant or non-compliant.

[0173] The method may include removing the medical device (at step 2410). The second balloon may be deflated, or otherwise transitioned to an unexpanded state, prior to removal of the second medical device. In some embodiments, the first balloon and the second balloon share a single inflation lumen, and thus are inflated and deflated in tandem. In alternate embodiments, the first balloon and the second balloon each have their own respective inflation lumen, and can be inflated and deflated independently with respect to one another. In still additional embodiments, either the first balloon, the second balloon, or both, may be the balloons as disclosed above with respect to FIGS. 17A-21 above, and do not need an inflation lumen at all.

[0174] Also included in the present disclosure is a method of treating a vessel. In some examples, the method includes providing a medical device within a compliant balloon to a treatment site. The treatment site may be a location of calcified lesions, or other sites needing treatment through the providing of energy, such as a shock wave. According to some examples, the method includes inflating the compliant balloon such that it makes contact with the point of treatment. This point of treatment may be the vessel wall itself, calcified plaque on the surface of the vessel wall, or other substances that may line the wall of the vessel.

[0175] The method may include providing energy (such as that provided by the use of laser energy to form a shock wave) to the treatment site. This energy may be used to break up calcific lesions in the treatment site. In some embodiments, the method includes deflating the compliant balloon after the energy has been provided. According to some examples, the method includes removing the medical device from the treatment site.

[0176] The method may include following up this initial treatment with a semi-compliant or non-compliant balloon. The semi-compliant or non-compliant balloon may or may not includePCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT additional implements for administration of energy to the treatment site. In some embodiments, the method includes inflating the semi-compliant or non-compliant balloon within the treatment site. This may provide dilatation to the calcified lesion and / or the vessel wall itself where necessary.

[0177] Also included in the present disclosure is a medical device including an elongated body having a distal elongated body portion and a central longitudinal axis. According to some embodiments, the medical device includes a compliant balloon positioned along the distal elongated body portion, the compliant balloon having an interior balloon surface and an exterior balloon and configured to receive a fluid to inflate the compliant balloon such that the exterior balloon surface contacts a calcified lesion within a vasculature of a patient. The medical device may include one or more pressure wave emitters positioned along the central longitudinal axis of the elongated body within the compliant balloon, the one or more pressure wave emitters configured to propagate at least one pressure wave through the fluid to fragment the calcified lesion. In some embodiments, at least one of the pressure wave emitters includes an optical fiber configured to transmit laser energy into the compliant balloon. According to some embodiments, the laser energy is configured to create a cavitation bubble in the fluid upon contact with the fluid to generate the at least one pressure wave.

[0178] Considerations for use of a compliant balloon with a procedure such as intravascular lithotripsy include the lubricity and rupture resistance of the material. Therapy delivery and optimization for the laser energy provided through the optical fiber must also be considered in order to ensure cavitation formation over a large range of pressures, as the compliant balloon may not need to be fully pressurized in the case of smaller vessels or areas of small diameter entrance because of calcific build-up.

[0179] Additionally, control of the growth of the compliant balloon at given pressures is desired, specifically through the use of compliance controls. This may permit for repeat treatments using the same compliant balloons while maintaining consistency in the treatment delivered.

[0180] 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.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT

[0181] 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.

[0182] To increase the clarity of various features, other features are not labeled in each figure.

[0183] 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, elements may be added to, removed from, or rearranged compared to the disclosed example embodiments.

[0184] 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 thePCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT 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.

[0185] 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.

[0186] 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 APPLICA TION DOCKET NO. FASTWAVE-015PCTCLAIMSWe Claim:

1. A medical device, comprising: an elongated body; a balloon positioned at a distal portion of the elongated body, the balloon configured to receive a fluid to inflate such that an exterior surface of the balloon is configured to contact an interior surface of a treatment site within a vasculature of a patient, the balloon configured to transition between an uninflated state and an inflated state, wherein, when the balloon is in the uninflated state, the balloon is pleatless; and one or more pressure-wave emitters positioned along a central longitudinal axis of the elongated body within the balloon, the one or more pressure-wave emitters configured to propagate pressure waves radially outward through the fluid to fragment a calcified lesion at the treatment site, wherein at least one of the pressure-wave emitters comprises an optical fiber configured to transmit laser energy into the balloon, and wherein the laser energy is configured to create a cavitation bubble in the fluid to generate the pressure waves.

2. The medical device of Claim 1, wherein the balloon is a first balloon, the medical device further comprising a second balloon positioned proximal to the first balloon and on or about the elongated body, the second balloon configured to receive a fluid to inflate such that an exterior surface of the second balloon is configured to increase dilation of the vasculature at the treatment site.

3. The medical device of Claim 2, wherein the first balloon is a compliant balloon, and wherein the second balloon is either i) a semi-compliant balloon or ii) a non-compliant balloon.

4. A medical device, comprising: an elongated body; a balloon positioned at a distal portion of the elongated body, the balloon containing a fluid prior to being delivered to a treatment site within a vasculature of a patient, the balloon configured to transition between an untensioned state and a tensioned state such that, when thePCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT balloon is in the untensioned state, an exterior surface of the balloon is configured to contact an interior surface of the treatment site; and one or more pressure-wave emitters positioned along a central longitudinal axis of the elongated body within the balloon, the one or more pressure-wave emitters configured to propagate pressure waves radially outward through the fluid to fragment a calcified lesion at the treatment site, wherein at least one of the pressure-wave emitters comprises an optical fiber configured to transmit laser energy into the balloon, and wherein the laser energy is configured to create a cavitation bubble in the fluid to generate the pressure waves.

5. The medical device of Claim 4, wherein, when the balloon is in the tensioned state, an outer diameter of the balloon is less than an outer diameter of the balloon in the untensioned state.

6. The medical device of Claim 4 or 5, further comprising a wire positioned along the elongated body and attached to a proximal portion of the balloon.

7. The medical device of Claim 6, wherein pulling on the wire causes the balloon to be in the tensioned state.

8. The medical device of Claim 6 or 7, wherein pushing on the wire causes the balloon to be in the untensioned state.

9. The medical device of any of Claims 6-8, wherein an absence of force on the wire causes the balloon to be in the untensioned state.

10. The medical device of Claim 4 or 5, further comprising a wire positioned along the elongated body and attached to a distal portion of the balloon.

11. The medical device of Claim 10, wherein pushing on the wire causes the balloon to be in the tensioned state.

12. The medical device of Claim 10 or 11, wherein pulling on the wire causes the balloon to be in the untensioned state.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT13. The medical device of any of Claims 10-12, wherein an absence of force on the wire causes the balloon to be in the untensioned state.

14. The medical device of any of Claims 4-13, wherein the balloon is a first balloon, the medical device further comprising a second balloon positioned proximal to the first balloon and on or about the elongated body, the second balloon configured to receive a fluid to inflate such that an exterior surface of the second balloon is configured to increase dilation of the vasculature at the treatment site.

15. A medical device, comprising: an elongated body; a balloon positioned at a distal portion of the elongated body, the balloon configured to permit ingress of blood disposed within a vasculature of a patient, so as to inflate an exterior surface of the balloon, the exterior surface thereby configured to contact an interior surface of a treatment site within the vasculature of the patient; and one or more pressure-wave emitters positioned along a central longitudinal axis of the elongated body within the balloon, the one or more pressure-wave emitters configured to propagate pressure waves radially outward through the blood to fragment a calcified lesion at the treatment site, wherein at least one of the pressure-wave emitters comprises an optical fiber configured to transmit laser energy into the balloon, and wherein the laser energy is configured to create a cavitation bubble in the blood to generate the pressure waves.

16. The medical device of Claim 15, wherein the balloon is a first balloon, the medical device further comprising a second balloon positioned proximal to the first balloon and on the elongated body, the second balloon configured to receive a fluid to inflate such that an exterior surface of the second balloon is configured to increase dilation of the vasculature at the treatment site.

17. The medical device of Claim 16, wherein the first balloon is a compliant balloon, and wherein the second balloon is either i) a semi-compliant balloon or ii) a non-compliant balloon.

18. A medical device, comprising: an elongated body;PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT a balloon wound about a distal portion of the elongated body, the balloon configured to receive a fluid to inflate such that an exterior surface of the balloon is configured to contact an interior surface of a treatment site within a vasculature of a patient in a helical manner; and one or more pressure-wave emitters positioned along a central longitudinal axis of the elongated body within the balloon, the one or more pressure-wave emitters configured to propagate pressure waves radially outward through the fluid to fragment a calcified lesion at the treatment site, wherein at least one of the pressure-wave emitters comprises an optical fiber configured to transmit laser energy into the balloon, wherein the optical fiber is configured to wind about the distal portion of the elongated body within the balloon, and wherein the laser energy is configured to create a cavitation bubble in the fluid to generate the pressure waves.

19. The medical device of any of Claims 1-18, wherein the balloon is a compliant balloon.

20. The medical device of any of Claims 1-19, wherein a distal end of the balloon comprises a bull nose.

21. The medical device of Claim 20, wherein the bull nose extends distally with respect to a distal end of the elongated body.

22. The medical device of any of Claims 1-21, wherein the balloon comprises a through lumen extending longitudinally through the balloon, the through lumen configured to permit a passage of a fluid through the balloon separate from an interior of the balloon while the balloon is in an expanded state.

23. The medical device of Claim 22, wherein the fluid is blood, and wherein the through lumen is configured to permit blood to at least partially flow through the balloon separate from the interior of the balloon while the balloon is in the expanded state.

24. The medical device of Claim 22 or 23, wherein the through lumen is one of a plurality of through lumens extending through the balloon.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT25. The medical device of any of Claims 1-24, further comprising a constraining feature located on an exterior surface of the balloon, the constraining feature configured to prevent a portion of the balloon from expanding beyond the constraining feature.

26. The medical device of Claim 25, wherein the portion of the balloon prevented from expanding beyond the constraining feature is configured to permit blood to flow past the balloon through the vasculature.

27. The medical device of Claim 25 or 26, wherein the constraining feature is one of a plurality of constraining features of the medical device.

28. The medical device of any of Claims 1-27, wherein the balloon is pleatless when in an unexpanded state.

29. The medical device of Claim 28, wherein the unexpanded state is i) a state of deflation or ii) a state of longitudinal tension.

30. A method, comprising: inserting a first medical device including a first balloon into a treatment site within a vasculature of a patient; inflating the first balloon such that an exterior surface of the first balloon contacts an interior surface of the treatment site; forming pressure waves inside the first balloon; removing the first medical device from the treatment site; inserting a second medical device including a second balloon into the treatment site; inflating the second balloon such that an exterior surface of the second balloon causes increased dilation of the vasculature at the treatment site; and removing the second medical device from the treatment site.

31. The method of Claim 30, wherein the first balloon comprises a compliant material, and wherein the second balloon comprises either i) a semi-compliant material or a ii) non-compliant material.

32. The method of Claim 30 or 31, wherein the first balloon is configured to be delivered to the treatment site in a pleatless configuration.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT33. The method of any of Claims 30-32, wherein inflating the first balloon comprises permitting ingress of blood into the first balloon.

34. A method, comprising: inserting a first medical device including a first balloon into a treatment site within a vasculature of a patient, wherein the first balloon contains a fluid; transitioning the first balloon from a tensioned state to an untensioned state such that an exterior surface of the first balloon contacts an interior surface of the treatment site; forming pressure waves inside the first balloon; removing the first medical device from the treatment site; inserting a second medical device including a second balloon into the treatment site; inflating the second balloon such that an exterior surface of the second balloon causes increased dilation of the vasculature at the treatment site; and removing the second medical device from the treatment site.

35. The method of Claim 34, wherein transitioning the first balloon from the tensioned state to the untensioned state comprises releasing a tension at a proximal portion of the first balloon.

36. The method of Claim 35, wherein releasing the tension at the proximal portion of the first balloon comprises releasing a wire attached to the proximal portion of the first balloon.

37. The method of Claim 35, wherein releasing the tension at the proximal portion of the first balloon comprises pushing on a wire attached to the proximal portion of the first balloon.

38. The method of Claim 34, wherein transitioning the first balloon from the tensioned state to the untensioned state comprises releasing a tension at a distal portion of the first balloon.

39. The method of Claim 38, wherein releasing the tension at the distal portion of the first balloon comprises releasing a wire attached to the distal portion of the first balloon.

40. The method of Claim 38, wherein releasing the tension at the distal portion of the first balloon comprises pulling on a wire attached to the distal portion of the first balloon.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT41. The method of any of Claims 34-40, further comprising transitioning the first balloon from the untensioned state to the tensioned state prior to removing the first medical device from the treatment site.

42. The method of Claim 41, wherein transitioning the first balloon from the untensioned state to the tensioned state comprises applying a tension at a proximal portion of the first balloon.

43. The method of Claim 42, wherein applying the tension at the proximal portion of the first balloon comprises pulling on a wire attached to the proximal portion of the first balloon.

44. The method of Claim 41, wherein transitioning the first balloon from the untensioned state to the tensioned state comprises applying a tension at a distal portion of the first balloon.

45. The method of Claim 44, wherein applying the tension at the distal portion of the first balloon comprises pushing on a wire attached to the distal portion of the first balloon.

46. A method, comprising: inserting a medical device including a first balloon and a second balloon proximal to the first balloon into a treatment site within a vasculature of a patient, wherein the first balloon is disposed adjacent to the treatment site; inflating the first balloon such that an exterior surface of the first balloon contacts an interior surface of the treatment site; forming pressure waves inside the first balloon; inserting the medical device further into the vasculature such that the second balloon is adjacent to the treatment site; inflating the second balloon such that an exterior surface of the second balloon causes increased dilation of the vasculature at the treatment site; and removing the medical device from the treatment site.

47. The method of Claim 46, wherein inflating the first balloon comprises transitioning the first balloon from a tensioned state to an untensioned state.

48. The method of Claim 47, wherein transitioning the first balloon from the tensioned state to the untensioned state comprises releasing a tension at a proximal portion of the first balloon.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-015PCT49. The method of Claim 48, wherein releasing the tension at the proximal portion of the first balloon comprises releasing a wire attached to the proximal portion of the first balloon.

50. The method of Claim 48, wherein releasing the tension at the proximal portion of the first balloon comprises pushing on a wire attached to the proximal portion of the first balloon.

51. The method of Claim 47, wherein transitioning the first balloon from the tensioned state to the untensioned state comprises releasing a tension at a distal portion of the first balloon.

52. The method of Claim 51, wherein releasing the tension at the distal portion of the first balloon comprises releasing a wire attached to the distal portion of the first balloon.

53. The method of Claim 51, wherein releasing the tension at the distal portion of the first balloon comprises pulling on a wire attached to the distal portion of the first balloon.

54. The method of any of Claims 47-53, further comprising transitioning the first balloon from the untensioned state to the tensioned state prior to removing the medical device from the treatment site.

55. The method of any of Claims 47-54, wherein transitioning the first balloon from the untensioned state to the tensioned state comprises applying a tension at a proximal portion of the first balloon.

56. The method of Claim 55, wherein applying the tension at the proximal portion of the first balloon comprises pulling on a wire attached to the proximal portion of the first balloon.

57. The method of Claim 54, wherein transitioning the first balloon from the untensioned state to the tensioned state comprises applying a tension at a distal portion of the first balloon.

58. The method of Claim 57, wherein applying the tension at the distal portion of the first balloon comprises pushing on a wire attached to the distal portion of the first balloon.

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