Pleatless delivery intravascular lithotripsy system

Abstract

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 target treatment site within a vasculature of a patient. According to some embodiments, the balloon is configured to transition between an uninflated state and an inflated state. When the balloon is in the uninflated state, the balloon may be pleatless. In 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 target treatment site.

Description

PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCTPLEATLESS 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 / 679,553; 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 target treatment site within a vasculature of a patient. According to some embodiments, the balloon is configured to transition between an uninflated state and an inflated state. When the balloon is in the uninflated state, the balloon may be pleatless. In 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 target treatment site. According to some embodiments, at least one of the one or more pressure-wave emitters includes an electronic emitter including a first electrode and a second electrode. The first electrode and the second electrode may be arranged to define a spark gap between the first electrode and the second electrode.

[0005] In some embodiments, the balloon is a first balloon, and the medical device further includes a second balloon positioned proximal to the first balloon and on the elongated body.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCTAccording to some embodiments, the second balloon is 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 target treatment site. The first balloon may be a compliant balloon. In some embodiments, the second balloon is either i) a semi-compliant balloon or ii) a non-compliant balloon.

[0006] 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. According to some embodiments, the balloon is configured to transition between an untensioned 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. The medical device may include one or more pressure-wave emitters positioned along a central longitudinal axis of the elongated body within the compliant 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 target treatment site. In some embodiments, at least one of the one or more pressure-wave emitters includes an electronic emitter including a first electrode and a second electrode. According to some embodiments, the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode.

[0007] When the balloon is in the tensioned state, an outer diameter of the balloon may be less than an outer diameter of the balloon in the untensioned state.

[0008] In some embodiments, the medical device further includes a wire positioned along the elongated body and attached to a proximal portion of the balloon. According to some embodiments, pulling on the wire causes the balloon to be in the tensioned state. Pushing 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.

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

[0010] The balloon may be a first balloon. In some embodiments, the medical device further includes a second balloon positioned proximal to the first balloon and on the elongated body. According to some embodiments, the second balloon is configured to receive a fluid to inflatePCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT such that an exterior surface of the second balloon is configured to increase dilation of the vasculature at the target treatment site.

[0011] 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 and thereby inflate such that an exterior surface of the balloon is configured to contact an interior surface of a target treatment site within a vasculature of a 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 fluid to fragment a calcified lesion at the target treatment site. At least one of the one or more pressure-wave emitters may include an electronic emitter including a first electrode and a second electrode. In some embodiments, the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode.

[0012] According to some embodiments, the balloon is a compliant balloon. The balloon may be a first balloon. In some embodiments, the medical device further includes a second balloon positioned proximal to the first balloon and on the elongated body. According to some embodiments, the second balloon is 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 target treatment site.

[0013] The first balloon may be a compliant balloon, and the second balloon may be either i) a semi-compliant balloon or ii) a non-compliant balloon.

[0014] In some embodiments, the balloon is a compliant balloon. According to some embodiments, a distal end of the balloon includes a bull nose. The bull nose may extend distally with respect to a distal end of the elongated body.

[0015] In some embodiments, the balloon includes a through lumen extending longitudinally through the balloon. According to some embodiments, the through lumen is configured to permit the passage of a fluid through the balloon separate from an interior of the balloon while the balloon is in an expanded state. The fluid may be blood. In 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. According to some embodiments, the through lumen is one of a plurality of through lumens extending through the balloon.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT

[0016] The medical device may further include a constraining feature located on an exterior surface of the balloon. In some embodiments, the constraining feature is 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.

[0017] 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.

[0018] Also included in the present disclosure is a method, including inserting a first medical device including a first balloon into a target 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 target 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 target treatment site. In some embodiments, the method includes inserting a second medical device including a second balloon into the target 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 target treatment site. The method may include removing the second medical device from the target treatment site.

[0019] 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. The first balloon may be configured to 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.

[0020] Also included in the present disclosure is a method, including inserting a first medical device including a first balloon into a target 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 target 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 target treatment site. According to some embodiments, the method includes inserting a second medical device, including a second balloon into the target treatment site. The method mayPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT include inflating the second balloon such that an exterior surface of the second balloon causes increased dilation of the vasculature at the target treatment site. In some embodiments, the method includes removing the second medical device from the target treatment site.

[0021] 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.

[0022] 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.

[0023] 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 target 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.

[0024] 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.

[0025] 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 target treatment site within a vasculature of a patient. In some embodiments, the first balloon is disposed adjacent to the target 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 target 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 target treatment site. According to some embodiments, the method includes inflating the second balloon such thatPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT an exterior surface of the second balloon causes increased dilation of the vasculature at the target treatment site. The method may include removing the medical device from the target treatment site.

[0026] 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.

[0027] 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.

[0028] In 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 target treatment site. According to some embodiments, transitioning the first balloon from the untensioned state to the tensioned state includes applying a tension at a proximal portion of the first balloon. Applying the tension at the proximal portion of the first balloon may include pulling on a wire attached to the proximal portion of the first balloon.

[0029] In 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. According to some embodiments, applying the tension at the distal portion of the first balloon includes pushing on a wire attached to the distal portion of the first balloon.

[0030] 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.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCTBRIEF DESCRIPTION OF THE DRAWINGS

[0031] 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.

[0032] FIG. 1 illustrates a diagrammatic view of an intravascular lithotripsy (IVL) system as it may appear inserted into a patient’s vasculature.

[0033] FIG. 2 illustrates a conceptual diagram of an example IVL system, including an energy generator and a catheter having a pressure-wave-emitter array within an interventional balloon.

[0034] FIG. 3. illustrates a conceptual block diagram illustrating some example components of the energy generator of FIG. 2.

[0035] FIG. 4A illustrates a cross-sectional view of a semi-compliant or non-compliant balloon, according to some embodiments.

[0036] FIG. 4B illustrates a cross-sectional view of the semi-compliant or non-compliant balloon of FIG. 4A as it unfolds, according to some embodiments.

[0037] FIG. 4C illustrates a cross-sectional view of the semi-compliant or non-compliant balloon of FIG. 4A as it may appear fully inflated.

[0038] FIG. 5A illustrates a cross-sectional view of a compliant balloon in an unexpanded state, according to some embodiments.

[0039] FIG. 5B illustrates a cross-sectional view of the compliant balloon of FIG. 5 A as it may appear fully inflated.

[0040] FIG. 6A illustrates a side view of a compliant balloon in an unexpanded state, according to some examples.

[0041] FIG. 6B illustrates a side view of the compliant balloon of FIG. 6A as it may appear fully inflated.

[0042] FIG. 6C illustrates an additional side view of the compliant balloon of FIG. 6A as it may appear fully inflated.

[0043] FIG. 6D illustrates a third side view of the compliant balloon of FIG. A as it may appear fully inflated.

[0044] FIG. 7A illustrates a side view of a compliant balloon in an unexpanded state, according to some embodiments.

[0045] FIG. 7B illustrates a side view of the compliant balloon of FIG. 9A as it may appear fully inflated.

[0046] FIG. 8A illustrates a side view of a balloon including a blood flow lumen, according to some embodiments.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT

[0047] FIG. 8B illustrates a cross-sectional view of the balloon of FIG. 8 A.

[0048] FIG. 9A illustrates a side view of a balloon including features to permit blood flow, according to some embodiments.

[0049] FIG. 9B illustrates a cross-sectional view of the balloon of FIG. 9A.

[0050] FIG. 10A illustrates a side view of another balloon including features to permit blood flow, according to some embodiments.

[0051] FIG. 10B illustrates a cross-sectional view of the balloon of FIG. 10 A, according to some embodiments.

[0052] FIG. 11 illustrates a side view of a medical device with multiple balloons, according to some embodiments.

[0053] FIG. 12A illustrates a side view of a balloon in a tensioned state, according to some embodiments.

[0054] FIG. 12B illustrates a side view of the balloon of FIG. 12A in an untensioned state, according to some embodiments.

[0055] FIG. 13 A illustrates a side view of a balloon in a tensioned state, according to some embodiments.

[0056] FIG. 13B illustrates a side view of the balloon of FIG. 13B in an untensioned state, according to some embodiments.

[0057] FIG. 14A illustrates a side view of a balloon in a tensioned state, according to some embodiments.

[0058] FIG. 14B illustrates a side view of the balloon of FIG. 14A in an untensioned state, according to some embodiments.

[0059] FIG. 15A illustrates a side view of a balloon in a tensioned state, according to some embodiments.

[0060] FIG. 15B illustrates a side view of the balloon of FIG. 15B in an untensioned state, according to some embodiments.

[0061] FIG. 16 illustrates a flowchart depicting a method of treating a vessel using two balloons, according to some embodiments.

[0062] FIG. 17 illustrates a flowchart depicting another method of treating a vessel using two balloons, according to some embodiments.

[0063] FIG. 18 illustrates a flowchart depicting another method of treating a vessel using two balloons, according to some embodiments.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCTDETAILED DESCRIPTION

[0064] 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.

[0065] 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.

[0066] 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.

[0067] 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 electrode emitters or pairs of electrodes.

[0068] FIG. 1 illustrates a diagrammatic view of an IVL system 10 as it may appear inserted into a patient’s vasculature. The IVL system 10 may include an IVL device 20, perhaps including an interventional balloon. During a lesion-disintegration procedure, a clinician may advance the medical device through an access point 12 in the patient 30, 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 IVL device 20 may then be advanced through the vasculature of the patient 30 until it reaches the vessel 40 containing the treatment area 50. For IVL, the treatment area may include a calcified lesion 60.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT

[0069] As shown in FIG. 2, IVL device 20 includes a fluid-inflatable interventional balloon 208 and a pressure-wave emitter array 210 positioned within the balloon 208. The emitter array 210 may include one or more individual emitter 212a-212e. For example, interventional balloon 208, or a distal portion of elongated body 206 passing therethrough, may define a central longitudinal axis 214, and emitters 212a-212e may be distributed longitudinally along central longitudinal axis 214.

[0070] In particular, the example emitter array 210 shown in FIG. 2 includes a first emitter 212a, a second emitter 212b, a third emitter 212c, a fourth emitter 212d, and a fifth emitter 212e. While five emitters 212 are illustrated in FIG. 2, emitter array 210 of IVL device 20 may include as few as one individual emitter and up to as many emitters as could reasonably fit within balloon 208. Each emitter 212 is configured to receive energy from energy generator 202 and use the received energy to generate and transmit high-energy pressure waves through balloon 208 and across the target treatment site. Emitters 212 may use the received energy to generate a cavitation bubble within the fluid inside balloon 208, propagating one or more high- energy pressure waves radially outward through balloon 208 and the calcified lesion. 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, further destabilizing the internal structure of the calcified-plaque lesion. In some examples, one or more of emitters 212 can include an electrical-based emitter configured to receive electrical energy from generator 202, such as via one or more conductive wires, and generate a spark between a pair of electrodes, thereby triggering the initial cavitation.

[0071] FIG. 3 is a block diagram illustrating some example components of energy generator 202 of FIG. 2. A power input 302 (e.g., for conductively coupling to a wall port or another electricity source) connects to power module 324 and an internal power supply 308. As shown in FIG. 3, power module 324 can include, as various, non-limiting examples, a high-voltage direct current (DC)-DC converter 310, a high-voltage capacitor and transistor switch 312, a voltage and / or current measurement unit 316, and a device identification unit 322, configured to determine whether catheter 204 is an authorized device while catheter 204 is connected via catheter connector 304. For instance, energy generator 202 may be configured to disable energy output to catheter connector 304 when an unidentified device is connected.

[0072] Generator 202 can include a memory and one or more processors, such as processor 318 and / or user-interface-control processor 326. User interface (UI) control processor 326 is configured to provide functionality for the user interface 334 of energy generator 202, such asPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT a display screen, touch screen, buttons, or other manual controls enabling a user (e.g., a clinician) to operate the energy generator 202.

[0073] 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, it is difficult to rewrap a semi-compliant or non-compliant balloon.

[0074] FIG. 4A illustrates a cross-sectional view of a semi-compliant or non-compliant balloon 402, according to some embodiments. In this illustration, the semi-compliant or non-compliant balloon 402 is shown in a folded configuration. Within the semi-compliant or non-compliant balloon 402 is shown the elongated body 206 along with the emitter 212. In such a folded configuration, the semi-compliant or non-compliant balloon 402 would fold down in such a manner as to ensure there is still room for the elongated body 206 and emitter 212, while trying to maintain a minimal cross-profile for insertion into the vessel of a patient.

[0075] FIG. 4B illustrates a cross-sectional view of the semi-compliant or non-compliant balloon 402 of FIG. 4A as it unfolds, according to some embodiments. Still shown near the center of the semi-compliant or non-compliant balloon 402 are the elongated body 206 and the emitter 212. As inflation fluid is injected into the semi-compliant or non-compliant balloon 402, it begins to expand, and the areas of higher stress (areas where the semi-compliant or non- compliant balloon 402 was pleated) begin to appear as areas where the semi-compliant or non- compliant balloon 402 is no longer perfectly circular in cross-section.

[0076] FIG. 4C illustrates a cross-sectional view of the semi-compliant or non-compliant balloon 402 of FIG. 4A as it may appear fully inflated. Still shown near the center of the semi- compliant or non-compliant balloon 402 are the elongated body 206 and the emitter 212. As shown in FIG. 4C, the areas of higher stress now indicate an inward bias on the surface of the semi-compliant or non-compliant balloon 402. These points of bias create small treatment voids where the semi-compliant or non-compliant balloon 402 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.

[0077] While FIGS. 4A, 4B, and 4C each show three “pleats,” “folds,” and thereby areas of higher stress, in additional or alternative embodiments, any number of these features may bePCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT used as desired to create a set folded diameter and expanded diameter to facilitate passage through the vessel of a patient.

[0078] FIG. 5 A illustrates a cross-sectional view of a compliant balloon 502 in an unexpanded state, according to some embodiments. Also shown in FIG. 5A are the elongated body 206 and the emitter 212. The compliant balloon 502 is shown surrounding both the emitter 212 and the elongated body 206, but this is only a stylistic choice. In practice, the compliant balloon 502 would likely tightly hug both the elongated body 206 and the emitter 212, thereby minimizing the crossing profile of the device as a whole. (In this example, the compliant balloon 502 would hug the emitter 212 in locations where the emitter 212 is present, and the compliant balloon 502 would hug the elongated body 206 in locations where the emitter 212 is not present.) Stated another way, in some embodiments, the balloon 502 is pleatless when in its unexpanded state.

[0079] FIG. 5B illustrates a cross-sectional view of the compliant balloon 502 of FIG. 5A as it may appear fully inflated. Still shown near the center of the compliant balloon 502 are the elongated body 206 and the emitter 212. Because of the elastic nature of compliant balloons, once injected with an inflation fluid, the compliant balloon 502 would achieve near-perfect, or perfect, restoration to its circumferential shape (outside of external forces, as will be discussed in FIGS. 6C and 6D below).

[0080] Benefits of using a compliant balloon 502 include the fact that there are no folds when the compliant balloon 502 is in an uninflated state. This means that there is less risk of damaging any present emitters, and there is no need to rewrap the compliant balloon 502 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.

[0081] Additionally, compliant balloons have a greater ability to conform to the vessel for better apposition (as shown in FIG. 6C below), as well as the ability to treat variable vessel diameters (as shown in FIG. 6D below). Furthermore, a single compliant balloon may be able to cover all vessel sizes due to the expandable nature of compliant balloons. An operator would 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.

[0082] FIG. 6A illustrates a side view of a compliant balloon 502 in an unexpanded state, according to some examples. However, it may be more accurate to say that compliant balloon 502 is partially expanded in FIG. 6A in order to distinguish between the compliant balloon 502, the elongated body 206, and the emitters 212a, 212b, 212c, 212d, and 212e, as in a trulyPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT unexpanded state the compliant balloon 502 may more tightly hug these components. In any case, when the compliant balloon 502 is partially expanded or unexpanded, it has a smaller crossing profile, facilitating tracking of the catheter through the vessel 40 of the patient.

[0083] FIG. 6B illustrates a side view of the compliant balloon 502 of FIG. 6A as it may appear fully inflated. Still shown in FIG. 6B are the elongated body 206 and the emitters 212a, 212b, 212c, 212d, and 212e. Because a compliant balloon 502 will expand to fill the volume of that in which it is placed, the compliant balloon 502 will make full circumferential contact with the vessel 40 of the patient (in this figure, a healthy vessel). This full circumferential contact facilitates full treatment of the area.

[0084] FIG. 6C illustrates an additional side view of the compliant balloon 502 of FIG. 6A as it may appear fully inflated. Still shown in FIG. 6C are the elongated body 206 and the emitters 212a, 212b, 212c, 212d, and 212e. In this figure, the vessel 40 is unhealthy and includes calcified lesions 60. 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 502 will expand until at least some portions of the compliant balloon 502 are in contact with the calcified lesions 60 about the wall of the vessel 40, thus facilitating full treatment in this area.

[0085] FIG. 6D illustrates a third side view of the compliant balloon 502 of FIG. 6A as it may appear fully inflated. Still shown in FIG. 6D are the elongated body 206 and the emitters 212a, 212b, 212c, 212d, and 212e. In this figure, the vessel 40 is tapered, meaning there are regions of smaller diameter and larger diameter. Because of the elastic nature of compliant balloons, compliant balloon 502 may expand to make full contact with the wall of the vessel 40, both in the smaller and larger diameter regions simultaneously, thus facilitating full treatment in this area.

[0086] FIG. 7A illustrates a side view of a compliant balloon 502 in an unexpanded state, according to some embodiments. Once again, similar to FIG. 6A, it may be more accurate to say that the compliant balloon 502 is in a partially expanded state in order to distinguish between the compliant balloon 502, the elongated body 206, and the emitters 212a, 212b, 212c, 212d, and 212e, as in a truly unexpanded state the compliant balloon 502 may more tightly hug these components. In this figure, the distal tail end of the compliant balloon 502 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.

[0087] In either case, the elongated body 206 may be embedded within the balloon as shownPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT in FIG. 7A, or extend past the distal tail end of the compliant balloon 502 (not shown) by simply extending the elongated body 206 further, or tucking the distal tail end of the compliant balloon 502 further back.

[0088] FIG. 7B illustrates a side view of the compliant balloon 502 of FIG. 7A as it may appear fully inflated. Still shown in FIG. 7B are the elongated body 206 and the emitters 212a, 212b, 212c, 212d, and 212e. In this inflated state, the distal end of the compliant balloon 502 shows a bull nose 702. Such a bull nose 702 may protect the vessel from any contact with the elongated body 206 (which may include, for example, a distal portion of the body 206) or emitters 212a, 212b, 212c, 212d, and 212e in the distal direction.

[0089] The compliant balloon 502 also permits the bull nose 702 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.

[0090] 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.

[0091] 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, due to this inflation step being shorter.

[0092] FIG. 8A illustrates a side view of a balloon 802 including a blood flow lumen 804, and FIG. 8B illustrates a cross-sectional view thereof. The blood flow lumen may otherwise be called a “through lumen.” Still shown in FIG. 8A are the elongated body 206 and the emitters 212a, 212b, 212c, 212d, and 212e. As shown in FIG. 8B, the balloon 802 is not making contact with the vessel 40, but this is only to differentiate between the two components for explanation purposes, and in some embodiments, the balloon 802 would make contact with the vessel 40 for treatment.

[0093] The embodiment shown in FIGS. 8A and 8B may be suitable for application over aPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT range of balloon 802 compliances, including fully compliant, semi-compliant, and non- compliant. The blood flow lumen 804 may be a lumen extending through the balloon 802, including an opening near both the proximal and distal ends of the balloon 802. When the balloon 802 is in an inflated, or expanded, state, blood may be able to flow through the blood flow lumen 804, thus permitting treatment of the location without fully occluding the vessel.

[0094] Additionally, while the blood flow lumen 804 is shown above the elongated body 206 in FIGS. 8 A and 8B, in additional or alternative embodiments, the blood flow lumen 804 may rotate about the central axis of the elongated body 206 as the elongated body 206 is turned.

[0095] FIG. 9A illustrates a side view of a balloon 902, which may be at least partially or fully inflated, including features to permit blood flow, and FIG. 9B illustrates a cross-sectional view thereof. Still shown in FIG. 9 A are the elongated body 206 and the emitters 212a, 212b, 212c, 212d, and 212e. In this embodiment, constraining features 904 are included. These constraining features 904 may be located on an exterior surface of the balloon 902, and prevent the balloon 902 from expanding to the wall of the vessel 40 in these locations. While not shown in FIGS. 9A and 9B, the constraining features 904 may also be present on an interior surface of the balloon 902. Through prevention of full contact between the balloon 902 and the vessel 40, blood may flow about the balloon 902 while it is fully expanded, thus preventing full occlusion of the vessel 40 during treatment.

[0096] These constraining features 904 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 904 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 may be intentionally amplified in order to cause locations for blood to flow about the expanded balloon.

[0097] Additionally, while five constraining features are illustrated in FIGS. 9 A and 9B, in additional or alternative embodiments, any number of constraining features 904 (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.

[0098] FIG. 10A illustrates a side view of another balloon 1002, which may be at least partially or fully inflated, including features to permit blood flow, and FIG. 10B illustrates a cross- sectional view thereof. Still shown in FIG. 10A are the elongated body 206 and the emitters 212a, 212b, 212c, 212d, and 212e. As shown in FIG. 10B, the balloon 1002 is not makingPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT contact with the vessel 40, but this is only to differentiate between the two components for explanation purposes, and in some embodiments, the balloon 1002 would make contact with the vessel 40 for treatment.

[0099] Similar to FIGS. 9A and 9B above, the feature may be a constraining feature 1004. This constraining feature 1004 may be located on an exterior surface of the balloon 1002, and prevent the balloon 1002 from expanding to the wall of the vessel 40 in this location. While not shown in FIGS. 10A and 10B, the constraining feature 1004 may also be present on an interior surface of the balloon 1002. Through prevention of full contact between the balloon 1002 and the vessel 40 in this location, blood may flow about the balloon 1002 while it is fully expanded, thus preventing full occlusion of the vessel 40 during treatment.

[0100] While the constraining feature 1004 is shown above the elongated body 206 in FIGS. 10A and 10B, in some embodiments, the constraining feature 1004 may rotate about the central axis of the elongated body 206 as the elongated body 206 is turned.

[0101] The constraining feature 1004 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 1004 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.

[0102] In additional or alternative embodiments, any combination of perfusion embodiments from FIGS. 8A, 8B, 9A, 9B, 10A, and 10B may be used in conjunction with one another, or with any other embodiment as explored throughout the present disclosure.

[0103] FIG. 11 illustrates a side view of a medical device with multiple balloons, according to some embodiments. As shown, located on the elongated body 206, a first balloon 1102 may be present distal to a second balloon 1104. Inside the first balloon, emitters 212a, 212b, 212c, 212d, and 212e are shown.

[0104] The first balloon 1102 and the second balloon 1104 may be made from the same material. In some embodiments, the first balloon 1102 is compliant, and the second balloon 1104 is semi-compliant or non-compliant. The first balloon 1102 and the second balloon 1104 may share an inflation lumen. In additional or alternative embodiments, the first balloon 1102 and the second balloon 1104 each include their own, distinct, inflation lumen.

[0105] In any embodiment, the first balloon 1102 may be provided to a target treatment area,PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT such as near or adjacent a calcified lesion in a vasculature of a patient. The first balloon 1102 may then be inflated, such as via an inflation lumen. In embodiments where the first balloon 1102 is compliant, the first balloon 1102 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 1102 is inflated, the emitters 212a, 212b, 212c, 212d, and 212e may provide pressure waves to fracture the calcific lesion.

[0106] After pressure waves have been delivered, the first balloon 1102 may be deflated, and the medical device may be inserted further into the vasculature of the patient, such that the second balloon 1104 is near or adjacent the now fractured calcific lesion. Once in position, the second balloon 1104 may be inflated such as to further dilate, or post-dilate, the vessel. In embodiments where the second balloon 1104 is semi-compliant or non-compliant, the second balloon 1104 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.

[0107] In FIGS. 12A-15B, reference is made to a wire (wire 1206, 1302, 1406, and 1506). The term “wire” is intended to mean any structure that may run alongside the elongated body 206 and attach to the balloon to effect an external force on the balloon, such as a thread.

[0108] FIG. 12A illustrates a side view of a balloon 1202 in a tensioned state 1208, and FIG. 12B illustrates the balloon 1202 in an untensioned state 1210, according to some embodiments. The balloon 1202 may be located on an elongated body 206, and emitters 212a, 212b, 212c, 212d, and 212e may also be located along the elongated body 206 within the balloon 1202. The balloon 1202 may be compliant.

[0109] The balloon 1202 may be primed with a fluid 1204 that causes the balloon 1202 to inflate outside of an external force. Stated another way, the balloon 1202 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.

[0110] A wire 1206 may be provided and attached to a proximal portion of the balloon 1202. The wire 1206 may be pulled proximally in order to exert a force on the balloon 1202, and effectively decrease the diameter of the balloon 1202 through increasing the length of the balloon 1202 (e.g., placing the balloon in a tensioned state 1208). While not equivalent to an uninflated state, the decreased diameter state of the balloon 1202 may facilitate passage throughPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT a vasculature to a target treatment area.[OHl] Once the medical device is delivered to the target treatment area, the wire 1206 may either be released, allowing the balloon 1202 to return to its natural state of expansion absent outside force, or the wire 1206 may be pushed distally, forcing the balloon 1202 into a state of shortened length and thus increased diameter (e.g., placing the balloon in an untensioned state 1210). Once the treatment is completed, the wire 1206 may once again be pulled to decrease the effective diameter of the balloon for removal from the vasculature.

[0112] FIG. 13A illustrates a side view of a balloon 1202 in a tensioned state 1208, and FIG. 13B illustrates a side view of the balloon 1202 in an untensioned state 1210, according to some embodiments. The balloon 1202 may be located on an elongated body 206, and emitters 212a, 212b, 212c, 212d, and 212e may also be located along the elongated body 206 within the balloon 1202. The balloon 1202 may be compliant.

[0113] The balloon 1202 may be primed with a fluid 1204 that causes the balloon 1202 to inflate outside of an external force. Stated another way, the balloon 1202 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.

[0114] A wire 1302 may be provided and attached to a distal portion of the balloon 1202. The wire 1302 may be pushed distally in order to exert a force on the balloon 1202, and effectively decrease the diameter of the balloon 1202 through increasing the length of the balloon 1202 (e.g., placing the balloon in a tensioned state 1208). While not equivalent to an uninflated state, the decreased diameter state of the balloon 1202 may facilitate passage through a vasculature to a target treatment area.

[0115] Once the medical device is delivered to the target treatment area, the wire 1302 may either be released, allowing the balloon 1202 to return to its natural state of expansion absent outside force, or the wire 1302 may be pulled proximally, forcing the balloon 1202 into a state of shortened length and thus increased diameter (e.g., placing the balloon in an untensioned state 1210). Once the treatment is completed, the wire 1302 may once again be pushed to decrease the effective diameter of the balloon for removal from the vasculature.

[0116] FIG. 14A illustrates a side view of a balloon 1402 in a tensioned state, and FIG. 14B illustrates a side view of the balloon 1402 in an untensioned state according to some embodiments. The balloon 1402 may be located on an elongated body 206, and emitters 212a,PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT212b, 212c, 212d, and 212e may also be located along the elongated body 206 within the balloon 1402. The balloon 1402 may be compliant.

[0117] The balloon 1402 may be coupled to the elongated body 206 at a distal end, and at least partially, or completely, uncoupled from the elongated body 206 at a proximal end. This partial, or complete, disconnect between the balloon 1402 and the elongated body 206 at a proximal end may permit the ingress of blood 1404 in the vasculature of the patient into the balloon 1402. In this way, blood 1404 may be used to inflate, or expand, the balloon 1402, eliminating the need for additional fluid, such as the primed fluid balloons of FIGS. 12A-13B, or inflation lumens.

[0118] A wire 1406 may be provided and attached to a proximal portion of the balloon 1402. The wire 1406 may be pulled proximally in order to exert a force on the balloon 1402, and prevent the blood 1404 from fully expanding the balloon 1402. While not equivalent to an uninflated state, the decreased diameter state of the balloon 1402 may facilitate passage through a vasculature to a target treatment area.

[0119] Once the medical device is delivered to the target treatment area, the wire 1406 may be released, allowing blood to fully ingress the balloon 1402 and effectively inflate the balloon 1402 until contact is made with the vessel walls (or calcific lesions about the vessel walls). Once the treatment is completed, the wire 1406 may once again be pulled to decrease the effective diameter of the balloon 1402 for removal from the vasculature.

[0120] FIG. 15A illustrates a side view of a balloon 1502 in a tensioned state and FIG. 15B illustrates a side view of the balloon 1502 in an untensioned state, according to some embodiments. The balloon 1502 may be located on an elongated body 206, and emitters 212a, 212b, 212c, 212d, and 212e may also be located along the elongated body 206 within the balloon 1502. The balloon 1502 may be compliant.

[0121] The balloon 1502 may be coupled to the elongated body 206 at a proximal end, and at least partially, or completely, uncoupled from the elongated body 206 at a distal end. This partial, or complete, disconnect between the balloon 1502 and the elongated body 206 at a distal end may permit the ingress of blood 1504 in the vasculature of the patient into the balloon 1502. In this way, blood 1504 may be used to inflate, or expand, the balloon 1502, eliminating the need for additional fluid, such as the primed fluid balloons of FIGS. 12A-13B, or inflation lumens.

[0122] A wire 1506 may be provided and attached to a distal portion of the balloon 1502. The wire 1506 may be pushed proximally in order to exert a force on the balloon 1502, and prevent the blood 1504 from fully expanding the balloon 1502. While not equivalent to an uninflatedPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT state, the decreased diameter state of the balloon 1502 may facilitate passage through a vasculature to a target treatment area.

[0123] Once the medical device is delivered to the target treatment area, the wire 1506 may be released, allowing blood to fully ingress the balloon 1502 and effectively inflate the balloon 1502 until contact is made with the vessel walls (or calcific lesions about the vessel walls). Once the treatment is completed, the wire 1506 may once again be pushed to decrease the effective diameter of the balloon 1502 for removal from the vasculature.

[0124] The medical devices of FIGS. 14A-15B 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. 14A and 14B may better facilitate the ingress of blood 1404 into the balloon 1402. If blood is flowing contra to the direction of insertion of the medical device, the medical device of FIGS. 15A and 15B may better facilitate the ingress of blood 1504 into the balloon 1502.

[0125] FIG. 16 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 1600). 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.

[0126] According to some embodiments, the method includes inflating a first balloon (at step 1602). 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.

[0127] The method may include forming pressure waves (at step 1604). The pressure waves may be induced through electrical emitters. 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.

[0128] In some embodiments, the method includes removing the first medical device (at step 1606). The first balloon may be deflated, or transitioned to an unexpanded state, prior to removal of the first medical device.

[0129] According to some embodiments, the method includes inserting a second medical device into the target treatment site (at step 1608). The method may include inflating a second balloon (at step 1610). The second balloon may be inflated such that an exterior surface of thePCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT 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.

[0130] In some embodiments, the method includes removing the second medical device (at step 1612). The second balloon may be deflated, or otherwise transitioned to an unexpanded state, prior to removal of the second medical device.

[0131] FIG. 17 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 1700). The medical device may be any of the single balloon medical devices as illustrated and disclosed in FIGS. 12A- 15B above. The target treatment site may be within a vasculature of a patient.

[0132] According to some embodiments, the method includes transitioning a first balloon from a tensioned state to an untensioned state (at step 1702). As described above with respect to FIGS. 12A-13B, 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 including the natural diameter of expansion, or an opposing force may be presented, achieving an increased diameter of the first balloon.

[0133] 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.

[0134] The method may include forming pressure waves (at step 1704). The pressure waves may be induced through electrical emitters. The pressure waves may be strong enough to travel through the primed fluid and fracture any present calcific lesion in the target treatment site.

[0135] In some embodiments, the method includes removing the first medical device (at step 1706). 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.

[0136] According to some embodiments, the method includes inserting a second medicalPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT device into the target treatment site (at step 1708). The method may include inflating a second balloon (at step 1710). 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.

[0137] In some embodiments, the method includes removing the second medical device (at step 1712). The second balloon may be deflated, or otherwise transitioned to an unexpanded state, prior to removal of the second medical device.

[0138] FIG. 18 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 1800). The medical device may be the two balloon medical device as illustrated and disclosed in FIG. 11 above. The target treatment site may be within a vasculature of a patient.

[0139] According to some embodiments, the method includes inflating a first balloon (at step 1802). 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 including the natural diameter of expansion, or an opposing force may be presented, achieving an increased diameter of the first balloon.

[0140] 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.

[0141] The method may include forming pressure waves (at step 1804). The pressure waves may be induced through electrical emitters. 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.

[0142] In some embodiments, the method includes inserting the medical device further into aPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT vasculature of a patient (at step 1806). The first balloon may move past the target treatment segment until a second balloon is located near or adjacent to the treatment segment.

[0143] According to some embodiments, the method includes inflating a second balloon (at step 1808). 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.

[0144] The method may include removing the medical device (at step 1810). 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. 12A-15B above, and do not need an inflation lumen at all.

[0145] 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.

[0146] The method may include providing energy (such as that provided by the use of electrical energy to pass over a spark gap in order 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.

[0147] 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 include 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 thePCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT treatment site. This may provide dilatation to the calcified lesion and / or the vessel wall itself where necessary.

[0148] Also included in the present disclosure is a medical device including an elongated body. According to some embodiments, the medical device includes a compliant balloon positioned at a distal portion of the elongated body. The compliant balloon may be configured to receive a fluid to inflate such that an exterior surface of the compliant balloon contacts an interior surface of a target treatment site within a vasculature of a patient. In some embodiments, the medical device includes one or more pressure-wave emitters positioned along a central longitudinal axis of the elongated body within the compliant balloon. According to some embodiments, the one or more pressure-wave emitters are configured to propagate pressure waves radially outward through the fluid to fragment a calcified lesion at the target treatment site. At least one of the one or more pressure-wave emitters may include an electronic emitter including a first electrode and a second electrode. In some embodiments, the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode.

[0149] 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 electrical energy provided through the emitter(s) 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.

[0150] 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.

[0151] 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.

[0152] 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 describedPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT 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.

[0153] To increase the clarity of various features, other features are not labeled in each figure.

[0154] 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.

[0155] Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless expressly stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and / or steps. Thus, such conditional language is not generally intended to imply that features, elements, and / or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and / or steps are included or are to be performed in any particular embodiment. The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless expressly stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus,PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT 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.

[0156] 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.

[0157] 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-014PCTCLAIMSWe 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 target 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 target treatment site, wherein at least one of the one or more pressure-wave emitters comprises an electronic emitter comprising a first electrode and a second electrode, and wherein the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode.

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 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 target treatment site.

3. The medical device of Claim 1 or 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 balloonPCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT configured to transition between an untensioned 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; and one or more pressure-wave emitters positioned along a central longitudinal axis of the elongated body within the compliant 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 target treatment site, wherein at least one of the one or more pressure-wave emitters comprises an electronic emitter comprising a first electrode and a second electrode, and wherein the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode.

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 any of Claims 4-6, wherein pulling on the wire causes the balloon to be in the tensioned state.

8. The medical device of any of Claims 4-7, wherein pushing on the wire causes the balloon to be in the untensioned state.

9. The medical device of any of Claims 4-8, 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 any of Claims 4, 5, or 10, wherein pushing on the wire causes the balloon to be in the tensioned state.

12. The medical device of any of Claims 4, 5, 10, or 11, wherein pulling on the wire causes the balloon to be in the untensioned state.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT13. The medical device of any of Claims 4, 5, or 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 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 target 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 and thereby inflate such that an exterior surface of the balloon is configured to contact an interior surface of a target treatment site within a vasculature of a 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 fluid to fragment a calcified lesion at the target treatment site, wherein at least one of the one or more pressure-wave emitters comprises an electronic emitter comprising a first electrode and a second electrode, and wherein the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode.

16. The medical device of Claim 15, wherein the balloon is a compliant balloon.

17. The medical device of Claim 15 or 16, 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 target treatment site.

18. The medical device of Claim 17, 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.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT19. 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 the 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.

25. 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.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT30. A method, comprising: inserting a first medical device including a first balloon into a target 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 target treatment site; forming pressure waves inside the first balloon; removing the first medical device from the target treatment site; inserting a second medical device including a second balloon into the target treatment site; inflating the second balloon such that an exterior surface of the second balloon causes increased dilation of the vasculature at the target treatment site; and removing the second medical device from the target 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 target treatment site in a pleatless configuration.

33. 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 target 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 target treatment site; forming pressure waves inside the first balloon; removing the first medical device from the target treatment site; inserting a second medical device including a second balloon into the target treatment site;PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT inflating the second balloon such that an exterior surface of the second balloon causes increased dilation of the vasculature at the target treatment site; and removing the second medical device from the target 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.

41. 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 target 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.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT45. 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 target treatment site within a vasculature of a patient, wherein the first balloon is disposed adjacent to the target treatment site; inflating the first balloon such that an exterior surface of the first balloon contacts an interior surface of the target 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 target treatment site; inflating the second balloon such that an exterior surface of the second balloon causes increased dilation of the vasculature at the target treatment site; and removing the medical device from the target 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.

49. 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.PCT UTILITY APPLICA TION DOCKET NO. FASTWAVE-014PCT53. 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 first medical device from the target 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 any of Claims 47-54, 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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