Apparatus for centering a pressure wave generator within a segmented balloon

Abstract

A catheter and segmented balloon system for a lithotripsy system with improved adaptability for curved configurations so as to minimize or prevent damage to the balloon during the generation of lithotripsy shock waves (e.g., damage caused by arcing of an electrode pair or use of a laser). Embodiments of the catheter include an elongated member with alternating regions of flexibility, where regions of higher rigidity are configured to support at least one lithotripsy emitter, and where regions of higher flexibility are disposed on either side of each region of higher rigidity. This configuration minimizes the risk that segments with lithotripsy emitter(s) will tend to bend in a manner that positions the emitters close to the balloon wall. Embodiments of the segmented balloon system include balloon segments with intervening segments between each segmented balloon, where the outer diameter of the inflated balloon segments is greater than the outer diameter of the intervening segments.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 650,044, filed May 21, 2024, entitled “CENTERPOSITIONING SEGMENTED FULID-FILLABLE ENCLOSURE AND ELONGATE MEMBER WITHALTERNATING FLEXIBLITY REGIONS FOR IVL SYSTEMS, DEVICES, AND METHODS”, entitled “CENTERPOSITIONING SEGMENTED FULID-FILLABLE ENCLOSURE AND ELONGATE MEMBER WITHALTERNATING FLEXIBLITY REGIONS FOR IVL SYSTEMS, DEVICES, AND METHODS”, filed May 19, 2025, entitled “DEVICES AND METHODS TO CENTER PRESSURE WAVE GENERATORS WITHIN A SEGMENTED BALLOON”, the entire contents of which are expressly incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to intravascular lithotripsy systems and other lithotripsy systems. More specifically, this disclosure relates to a fluid-fillable housing of an intravascular lithotripsy system and other lithotripsy systems, and an elongated member associated with the fluid-fillable housing. Background Technology

[0004] A wide variety of techniques and instruments have been developed to remove or repair tissue in arteries and similar body channels, including removing and / or fragmenting calcified lesions that form within and / or within the walls of defined channels. A common purpose of these techniques and instruments is to remove atherosclerotic plaques from a patient's arteries. Atherosclerosis is characterized by the accumulation of fatty deposits (atherosclerotic plaques) in the intima of a patient's blood vessels (i.e., under the endothelium). Often, over time, the material initially deposited as relatively soft, cholesterol-rich atherosclerotic material hardens within the vessel wall into calcified atherosclerotic plaques. These plaques restrict blood flow, causing the vessel to become less compliant than normal, and are therefore often referred to as stenotic lesions or stenosis, with the blocking material called stenotic material. If left untreated, such stenosis can lead to angina, high blood pressure, myocardial infarction, stroke, and other conditions.

[0005] Angioplasty, or balloon angioplasty, is an endovascular treatment procedure that widens narrowed or blocked arteries or veins (typically for treating atherosclerosis). Typically, a collapsed balloon is passed through a pre-positioned catheter and fitted with a guidewire to the narrowed occlusion, and then inflated to a fixed pressure.

[0006] The balloon forces the occlusion within the blood vessel and the surrounding muscular wall to expand until the occlusion yields under the radial force applied by the expanding balloon, opening the vessel with an internal diameter similar to that of the natural vessel in the occluded area, thereby improving blood flow. Generally, known IVL devices further include a voltage pulse generator operatively connected to one or more pairs of electrodes mounted on a catheter and within an inflatable balloon. These electrodes generate acoustic shock waves within the balloon, which are then transmitted to the surrounding vessel to be treated. These shock waves assist in the breakdown of calcified lesion tissue to improve blood flow. Such IVL devices can exhibit higher efficacy compared to conventional balloon angioplasty, which may not include the generation of any such shock waves.

[0007] The applicant has described intravascular lithotripsy systems, devices, and methods, for example, see PCT / 2022 / 074607 filed August 5, 2022, entitled “INTRAVASCULAR LITHOTRIPSY BALLOON SYSTEMS, DEVICES AND METHODS” and PCT / US2023 / 085868 filed December 23, 2023, entitled “INTRAVASCULAR LITHOTRIPSY SYSTEM WITH IMPROVED DURABILITY, EFFICIENCY ANDPRESSURE OUTPUT VARIABILITY”, the entire contents of which are hereby incorporated herein by reference.

[0008] like Figure 1The illustration provides a schematic or schematic layout of various parts of an exemplary and known IVL system 12. The exemplary IVL system 12 includes a catheter assembly 14 comprising an elongated body and a fluid-filled member 16. The elongated body is implemented as a catheter having a guidewire 15. An example of the fluid-filled member 16 is an inflatable balloon configured to contain conductive fluid therein. The fluid-filled member 16 is disposed near one end of the body and arranged to receive fluid for inflating to facilitate IVL treatment. A set of dischargeable, spaced-apart electrodes or other lithotripsy emitters 18 is shown arranged within the exemplary balloon 16, wherein the electrodes 18 are spaced apart from each other by gaps 17 to generate a spark or arc between these spaced-apart electrodes 18.

[0009] The IVL system embodiments described herein can be used in conjunction with electrodes within a fluid-filled member 16, which is configured to contain a fluid (e.g., a conductive fluid). Figure 1 As shown, the fluid filling member 16 may include an inflatable balloon, which may be compliant or non-compliant, and is used to contain fluid such that the spaced-apart electrodes 18 are preferably completely immersed in the contained fluid. Furthermore, the fluid filling member 16 may include at least partially rigid and / or non-flexible fillable members. In other embodiments, the fluid filling member 16 may contain fluid therein, and wherein the set of spaced-apart electrodes or other emitters 18 is most typically completely immersed in the contained fluid.

[0010] Alternatively, the IVL system control embodiments of this disclosure can be used in conjunction with electrodes not positioned or surrounded by a fluid-filled member or fluid-fillable member 16. In these embodiments, the IVL system may include one or more sets of spaced-apart electrodes or emitters 18 that may be continuously or periodically exposed to saline or other fluids, and during exposure, the IVL system may generate an electric arc between the spaced-apart electrodes or emitters 18. In all embodiments discussed herein, one or more sets of spaced-apart electrodes or emitters 18 may be provided. While electrode emitters may be described generally, other types of lithotripsy emitters are also possible (e.g., lasers).

[0011] Figure 1Each of the spaced-apart electrodes is arranged in communication with an electrical pulse generating system or voltage pulse generator 20 (as shown by the dashed conductor) to receive high-voltage electrical energy for generating a spark, thereby producing a pressure shock wave for IVL treatment. In an exemplary embodiment, one electrode may be grounded, and the other electrode may be supplied with a high voltage from the electrical pulse generating system 20; however, in some embodiments, any suitable voltage difference may be applied. The electrical pulse generating system 20 includes an IVL control system 22, which includes a processor 24 configured to execute instructions stored in a memory 26 and communication signals via circuitry 28 for IVL operation under processor control. The processor 24, memory 26, and circuitry 28 are arranged in communication with each other (as shown by the dashed line) to facilitate the disclosed operations.

[0012] Figure 2 An exemplary known IVL system is schematically illustrated, illustrating a method of applying voltage pulses to the system so that current flows through the exemplary system to each set of spaced electrodes 18, wherein the illustrated transmitters 18 are connected in series. Figure 2 Two sets of spaced-apart electrodes or emitters 18 are illustrated, each defined within a support SB. Voltage pulses from an electrical pulse generating system 20 are applied with sufficient amplitude and / or duration to the sets of series-connected, spaced-apart electrodes 18, resulting in the continuous generation of arcs across the spark gap 17 in a sequence consistent with the connection configuration of the electrodes and the electrical pulse generating system 20. In the illustrated example, the connection configuration is series-connected.

[0013] Targeted treatment areas such as calcifications, occlusions, and / or lesions within blood vessels or other bodily channels may appear within the curvilinear space. Figure 3 An example of a known IVL device 10, simulated within a curved blood vessel or conduit, is illustrated. As shown, the inner electrode support member 13 is bent within the balloon 14 to contact or nearly contact the balloon material on a portion of the outer radius of the bent inner electrode support member 13. This configuration causes the pairs of spaced-apart electrodes E to contact or be very close to the balloon material, offsetting the inner electrode support member 13 and the spaced-apart electrode pairs E in position towards the sides of the balloon 14. When the IVL system is activated to generate an arc between the spaced-apart electrodes E as discussed above, the resulting heat and energy from the generated arc can damage the balloon material, leading to undesirable weakening of the balloon 14 and potentially dangerous rupture. In addition, fluid contaminated with byproducts of the arcing process within the balloon 14 can be released into the patient's circulatory system. Furthermore, such rupture is unacceptable because it requires the practitioner to remove the ruptured balloon and replace it with another balloon to continue the treatment procedure. For various reasons, such rupture is unacceptable.

[0014] To reduce the incidence of such rupture, it would be beneficial to provide a lithotripsy system that minimizes or eliminates the possibility of electrodes or other lithotripsy emitters being misplaced to very close to the wall of a fluid-filled balloon when treating occlusions or lesions in curvilinear or tortuous blood vessels or channels (e.g., peripheral vessels). Various embodiments of this disclosure address at least some of these problems. Summary of the Invention

[0015] This summary is provided to introduce several concepts in a simplified form, which will be further described in the following detailed description. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to serve as an indication of the scope of the claimed subject matter.

[0016] One embodiment of this disclosure relates to a catheter for an intravascular lithotripsy (“IVL”) system or other lithotripsy system. Such a catheter may include an elongated member comprising a fluid-inflatable balloon, wherein alternating flexible regions are located along the elongated member within the fluid-inflatable balloon. The alternating flexible regions may include at least one region configured to support at least one lithotripsy emitter (e.g., a pair of electrodes, a laser, or other emitter), wherein the flexibility of at least one region is less than the flexibility of the remaining alternating flexible regions.

[0017] Another embodiment relates to a catheter for an intravascular lithotripsy (“IVL”) system or other lithotripsy system, the catheter comprising an elongated member having a distal region and one or more pairs of regions, the distal region being disposed along the distal portion of the elongated member, the one or more pairs of regions being longitudinally spaced from each other and disposed along a portion of the elongated member proximal to the distal region, wherein each pair of regions in the one or more pairs of regions is longitudinally spaced from each other by an intermediate region. The distal region and the intermediate region are more flexible than the one or more pairs of regions.

[0018] Another embodiment relates to a segmented balloon system for intravascular lithotripsy (“IVL”) systems or other lithotripsy systems, comprising an elongated member and two or more segmented balloons configured to surround a portion of the elongated member in a watertight manner. Each of the two or more segmented balloons is longitudinally spaced from adjacent segmented balloons or the outer shell by an insertion segment having an outer diameter upon inflatation. Each segmented balloon may include a conical proximal segment, a central cylindrical segment, and a conical distal segment. When the balloon inflates, the outer diameter of the central segment is larger than the outer diameter of the insertion segment.

[0019] Another embodiment relates to a segmented balloon system for intravascular lithotripsy (“IVL”) systems or other lithotripsy systems, including an elongated member and an outer member, the outer member including a lumen configured to receive the elongated member therein. Two or more segmented balloons are disposed, configured to surround a portion of the elongated member in a watertight manner with respect to the elongated member distally and to the outer member proximally. Each of the two or more segmented balloons is longitudinally spaced from adjacent segmented balloons or outer shells by an insertion segment having an outer diameter upon inflatation, wherein each segmented balloon includes a conical proximal segment, a central cylindrical segment, and a conical distal segment. When inflated, the outer diameter of the central segment is larger than the outer diameter of the insertion segment.

[0020] In any of the embodiments described, at least one gravel emitter may include at least a pair of spaced-apart electrodes, or a laser.

[0021] In any of the embodiments described, at least one region may be disposed along the elongated member at a location distal to and adjacent to an alternating flexible region having a flexibility greater than that of at least one region. Furthermore, at least one region may be disposed along the elongated member at a location proximal to and adjacent to an alternating flexible region having a flexibility greater than that of at least one region. In other words, at least one region may be situated between alternating flexible regions having a higher flexibility than at least one region.

[0022] In any of the embodiments described, at least one region may include 2, 3, 4 or 5 regions, which are longitudinally spaced apart from each other by alternating flexible regions with a flexibility greater than that of the 2, 3, 4 or 5 regions.

[0023] In any of the embodiments described, the catheter may further include a fluid-inflatable balloon surrounding at least 2, 3, 4 or 5 regions.

[0024] In any of the embodiments described, the fluid-inflatable balloon can be configured to surround at least a portion of the remaining alternating flexible regions.

[0025] In any of the embodiments described, the conduit may include one or more lithotripters disposed along an elongated member in each of one or more pairs of regions.

[0026] In any of the embodiments described, the catheter may include a fluid-inflatable balloon configured to surround one or more pairs of regions and each intermediate region.

[0027] In any of the embodiments described, the fluid-inflatable balloon surrounds at least a portion of one or more pairs of regions located proximal to the distal region.

[0028] In any of the embodiments of the segmented balloon system, two or more segmented balloons may be configured to be in fluid communication with each other.

[0029] In any of the embodiments of the segmented balloon system, when the segmented balloon system is bent or flexed, the elongated member can engage or contact at least one insertion segment.

[0030] In any of the embodiments of the segmented balloon system, the insertion segment that engages with the elongated member can be configured to space the elongated member from the inner surfaces of two or more segmented balloons.

[0031] In any of the embodiments of the segmented balloon system, the system may include one or more pairs of spaced-apart electrodes or other lithotripsy emitters associated with an elongated member and located within each of two or more segmented balloons.

[0032] In any of the described embodiments of the segmented balloon system, any of the described catheter systems may be included, wherein two or more segmented balloons are configured to surround a portion of an elongated member in a watertight manner, each of the two or more segmented balloons being longitudinally spaced from adjacent segmented balloons or the outer shell by an insertion segment having an outer diameter upon inflatation. Each segmented balloon may include a conical proximal segment, a central cylindrical segment, and a conical distal segment. Once inflated, the outer diameter of the central segment may be larger than the outer diameter of the insertion segment.

[0033] In any of the embodiments of the segmented balloon system, each of the two or more segmented balloons may be configured to surround at least one region configured to support at least one lithotripter.

[0034] In any of the embodiments of the segmented balloon system, the elongated member may include a flexible region that is more flexible than at least one region configured to support at least one lithotripter, wherein the flexible region is surrounded by the insertion segment.

[0035] In any of the embodiments of the segmented balloon system, two or more segmented balloons may be configured to be in fluid communication with each other.

[0036] In any of the embodiments of the segmented balloon system, when the segmented balloon system is bent or flexed, the elongated member can engage or contact at least one insertion segment.

[0037] In any of the embodiments of the segmented balloon system, each insertion segment engaging with the elongated member can be configured to space the elongated member from the inner surfaces of two or more segmented balloons.

[0038] Related usage methods may include using any of the systems described for IVL or other lithotripsy procedures.

[0039] This device differs from various previously disclosed configurations. For example, US2024 / 0226512 discloses a cone-shaped balloon configuration, but does not include the insertion section between adjacent balloon segments.

[0040] CN113730768A discloses an expandable balloon and a balloon expansion catheter, wherein a limiting portion or structure is disposed outside the balloon body to restrict the radial expansion at the location of the external limiting structure. In the embodiments of the presently described configuration, there is no external limiting structure placed on the balloon body as in this reference.

[0041] US2022 / 0313359 discloses an intravascular lithotripsy balloon comprising a proximal region diameter, a distal region diameter, and a transition region between the two, wherein the diameter of the transition region varies. Unlike at least some currently disclosed embodiments, it does not include regions of varying rigidity or insertion segments between adjacent balloon segments.

[0042] US11,583,339 discloses an asymmetric balloon for an intravascular lithotripsy device, the balloon including an energy guide that receives and directs energy from an energy source into the balloon interior. The energy guide includes a distal end positioned on the central axis of the balloon when the balloon inflates. This configuration provides maximum distance between the generated plasma and the balloon wall to reduce balloon rupture. No segmented balloon with an insertion section is provided, nor are the problems encountered when the balloon bends around bends within the vascular system, which tend to position the generated plasma closer to the balloon wall than in a straight configuration.

[0043] US11,484,327 discloses an intravascular lithotripsy device comprising multiple protective structures (such as cages) positioned outside a balloon, designed to reduce physical contact between the balloon's exterior and calcified plaque lesions attached to the vessel wall, thereby reducing the risk of balloon rupture or damage to the balloon wall. As noted above regarding CN113730768A, in the embodiment of the currently described configuration, there is no such external cage-like structure placed on the balloon body.

[0044] The entire contents of each of the foregoing references are incorporated herein by reference. While the foregoing references attempt to address various problems, they do not necessarily recognize or resolve problems associated with bending, and the tendency of the internal components supporting the lithotripter to bend toward the balloon wall when in a bent configuration, which are addressed by at least some embodiments of the present disclosure.

[0045] Additional features and advantages of exemplary implementations of the invention will be set forth in the following description and will be apparent in part from the description, or may be learned by practicing these exemplary implementations. The features and advantages of such implementations can be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features will become more apparent from the following description and the appended claims, or may be learned by practicing the exemplary implementations described below. Attached Figure Description

[0046] Various aspects and features of the invention will be described with reference to the various representative embodiments illustrated in the accompanying drawings. It should be understood that these drawings depict only exemplary embodiments of the invention and should not be construed as limiting its scope.

[0047] Figure 1 A schematic diagram of an IVL system is shown.

[0048] Figure 2 A schematic diagram of a portion of an IVL system is shown.

[0049] Figure 3 A side sectional view of a portion of a prior art IVL system is shown.

[0050] Figure 4 A side sectional view of an embodiment of the present disclosure is shown.

[0051] Figure 5 A side sectional view illustrating another embodiment of the present disclosure is shown.

[0052] Figure 6 A side sectional view illustrating another embodiment of the present disclosure is shown.

[0053] Figure 7 A side sectional view illustrating another embodiment of the present disclosure is shown.

[0054] Figure 8 A side sectional view illustrating another embodiment of the present disclosure is shown. Detailed Implementation

[0055] The following describes one or more specific embodiments of this disclosure. To provide a brief description of these embodiments, some features of actual embodiments are described in the specification. It should be understood that, in the development of any such actual embodiment, as in any engineering or design project, many embodiment-specific decisions will be made to achieve the developer's specific goals, such as compliance with system-related and business-related constraints, which may vary from embodiment to embodiment. It should be further understood that such development work may be complex and time-consuming, but will still be a routine design, manufacturing, and production effort for those skilled in the art who benefit from this disclosure.

[0056] While this disclosure will describe various specific implementations, it should be understood that the apparatuses, systems, and methods described herein can be adapted to other environments and other uses. Furthermore, elements described in connection with any embodiment depicted and / or described herein can be combined with elements described in connection with any other embodiment depicted and / or described herein.

[0057] Figure 4 An embodiment of the present disclosure is illustrated, and includes a segmented lithotripsy balloon system 100 having: a series of segmented balloons B1, B2, B3, B4; an outer member 102 operatively associated with a proximal cylindrical end segment 101 of the balloon system 100 in a watertight connection; and an inner member 103 extending through the lumen of the outer member 102 and further distally through the interior space of the balloon system 100 beyond the distal end of the outer member 102 to operatively engage the distal cylindrical end 110 of the segmented balloon system 100. Although primarily described as cylindrical, it should be understood that other shapes are also possible (e.g., oval cross-sections or other shapes).

[0058] Various embodiments are described herein as comprising a “balloon” or a series of balloon structures that are always in fluid communication. However, it should be understood that the term “balloon” is not limiting but should be interpreted broadly. Thus, any suitable watertight shell structure is within the scope of this disclosure.

[0059] The first segmented balloon B1 is shown as including a proximal cylindrical end segment 101 operatively associated with the outer surface of the outer member 102 to provide a watertight connection, a proximal conical segment 120 adjacent to the proximal cylindrical end segment 101, a central cylindrical segment 122 adjacent to the proximal conical segment 120, and a distal conical segment 124 adjacent to the central cylindrical segment 122.

[0060] The second segmental balloon B2 is shown as including a proximal conical segment 128, a central cylindrical segment 130 adjacent to the proximal conical segment 128, and a distal conical segment 132 adjacent to the central cylindrical segment 130.

[0061] The third segment balloon B3 is shown as including a proximal conical segment 136, a central cylindrical segment 138 adjacent to the proximal conical segment 136, and a distal conical segment 140 adjacent to the central cylindrical segment 138.

[0062] The fourth segment balloon B4 is shown as including a proximal conical segment 144, a central cylindrical segment 146 adjacent to the proximal conical segment 144, a distal conical segment 148 adjacent to the central cylindrical segment 146, and a distal cylindrical segment 110 adjacent to the distal conical segment 148, the distal cylindrical segment 110 being operatively associated with the outer surface of the inner member 103 to provide a watertight connection.

[0063] In the illustrated embodiment, the proximal cylindrical end segment 101 surrounds the distal portion of the outer member 102, and the distal cylindrical end segment 110 surrounds a portion of the inner member 103. The illustrated system 100 includes an inner member 103 disposed within and extending distally from the outer member 102. Consequently, the outer diameter of the outer member 102 will be larger than the outer diameter of the inner member 103. Therefore, the outer diameter of the proximal cylindrical segment 101 will be larger than the outer diameter of the distal cylindrical segment 110 in the illustrated embodiment. Those skilled in the art will recognize that this arrangement or configuration is not limiting, and, for example, a single elongated member having a substantially constant outer diameter can be used to establish an operatively watertight connection with the proximal cylindrical end segment 101 and the distal cylindrical end segment 110. In this embodiment, the outer diameters of the proximal cylindrical end segment 101 and the distal cylindrical end segment 110 can be substantially equal.

[0064] The first insertion cylindrical section 126 is shown positioned between the distal conical section 124 of the first segmented balloon B1 and the proximal conical section 128 of the second segmented balloon B2. The outer diameter of the first insertion cylindrical section 126 is smaller than the outer diameter of the middle cylindrical sections 122 and 130 of the first segmented balloon B1 and the second segmented balloon B2.

[0065] The second insertion cylindrical section 134 is shown positioned between the distal conical section 132 of the second segmented balloon B2 and the proximal conical section 136 of the third segmented balloon B3. The outer diameter of the second insertion cylindrical section 134 is smaller than the outer diameter of the middle cylindrical sections 130 and 138 of the second segmented balloon B2 and the third segmented balloon B3.

[0066] The third insertion cylindrical section 142 is positioned between the distal conical section 140 of the third segment balloon B3 and the proximal conical section 144 of the fourth segment balloon B4. The outer diameter of the third insertion cylindrical section 142 is smaller than the outer diameter of the middle cylindrical sections 138 and 146 of the third segment balloon B3 and the fourth segment balloon B4.

[0067] The segmented balloons B1 to B4 are in fluid communication with each other and with an external fluid reservoir (not shown, but will be familiar to those skilled in the art based on this disclosure), allowing the balloon system 100 to be inflated or deflated as a whole system 100 using fluid. In other embodiments, each segmented balloon B1 to B4 can be inflated independently to allow for customized inflating / deflation and actuation of spaced-apart electrodes or other lithotripsy emitters(s) within the inflated segmented balloons B1 to B4.

[0068] In the illustrated embodiments, the central cylindrical segments 122, 130, 138, and 146 may all include substantially equal outer diameters upon inflating. In other embodiments, the outer diameters 122, 130, 138, and 146 may include outer diameters that differ from each other upon inflating. In some embodiments, the outer diameters of the central cylindrical segments 122, 130, 138, and 146 may increase in the proximal direction, such that the outer diameter of the most distal central cylindrical segment 146 is the smallest, and the outer diameter of the most proximal central cylindrical segment 122 is the largest. Reverse arrangements are also possible (e.g., where balloon segment 146 has the largest outer diameter, and balloon segment 122 has the smallest outer diameter). Other configurations are also possible (e.g., balloon segments 130 and / or 138 may have larger diameters than the other balloon segments). All combinations of the outer diameters of the central cylindrical segments 122, 130, 138, and 146 upon inflating are within the scope of this disclosure.

[0069] Similarly, the outer diameters of the inserted cylindrical segments 126, 134, and 142 may include substantially the same outer diameter during expansion, or they may include different outer diameters during expansion.

[0070] In some embodiments, the axial lengths of the inserted cylindrical segments 126, 134, and 142 may be substantially equal. In other embodiments, the axial lengths of the inserted cylindrical segments may differ from one another. All combinations of the lengths of the inserted cylindrical segments are within the scope of this disclosure.

[0071] Similarly, the axial lengths of the segmented balloons B1 to B4 (i.e., in the case of segmented balloon B1, the distance between the proximal end of the proximal conical segment and the distal end of the distal conical segment) can be substantially equal. In other embodiments, the axial lengths of the segmented balloons B1 to B4 can be unequal. Similarly, the central cylindrical segments 122, 130, 138, and 146 can have substantially equal lengths. In other embodiments, the central cylindrical segments 122, 130, 138, and 146 can have unequal lengths. For example, the length of the most distal central cylindrical segment 122 can be less than the lengths of the other central cylindrical segments. All combinations of the lengths of the central cylindrical segments are within the scope of this disclosure.

[0072] Figure 4 Further examples illustrate the use of balloon systems, such as 100 Figure 4 The internal component 103, arranged along the longitudinal axis A through the segmented balloon system 100 in a straight line, is shown. Furthermore, each balloon B1, B2, B3, and B4 is shown as including at least one pair of spaced-apart electrodes, respectively designated as E1, E2, E3, and E4 as illustrated. It will be understood that alternative lithotripter emitters are also possible and within the scope of this disclosure. For example, similar to the electrode pairs, a laser can be used to generate plasma. For example, such a laser can be used to heat a metal target, which, upon heating, generates plasma accompanied by cavitation bubbles, etc. In either case, one or more lithotripter emitters E1 to E4 may be provided. Electrodes E1 to E4 are illustratively located within the central cylindrical segments 122, 130, 138, and 146. However, those skilled in the art will recognize that the number of spaced-apart electrode pairs or other lithotripter emitters within the balloon structures B1 to B4 may be one or more. Furthermore, those skilled in the art will recognize that the location of one or more pairs of electrodes or other lithotripsy emitters within each balloon structure B1 to B4 can be within the corresponding central cylindrical section, the corresponding proximal conical section, and / or the corresponding distal conical section. All such combinations are within the scope of this disclosure.

[0073] One advantage of the smaller outer diameter of the insertion cylindrical sections 126, 134, and 142 compared to the larger outer diameter of the central cylindrical sections 122, 130, 138, and 146 is that the distance between the inner member 103 and the balloon material within the insertion cylindrical sections 126, 134, and 142 is smaller than the distance between the inner member 103 and the balloon material within the central cylindrical sections 122, 130, 138, and 146. This difference allows for control of the radial position of the inner member 103 and the electrodes E1 to E4 during bending of the system 100.

[0074] like Figure 5 As shown, Figure 4 The segmented balloon system 100 is now illustrated as curved to mimic a curved blood vessel or tube. Return to Reference Figure 3 In existing devices, this bending causes an undesirable positional shift of the inner support member 13 relative to the balloon 14, resulting in... Figure 3 The individual electrode pairs or other emitters E are undesirably positioned close to the surface of the balloon 14.

[0075] In contrast, Figure 5In one embodiment, the inserting cylindrical segments 126, 134, and 142, with their smaller outer diameters relative to the larger outer diameters of the central cylindrical segments 122, 130, 138, and 146, provide a barrier or physical constraint on the radial extension of the inner member 103 and provide a surface against which the inner member 103 is pressed, causing additional bending of the inner member 103. In one embodiment, to maximize such control, the inner diameters associated with the inserting segments 126, 134, and 142 may be similar to the outer diameters of the inner member 103. For example, any gap between the inner member 103 and the inner diameters of the inserting segments 126, 134, and / or 142 may be less than 100%, less than 75%, less than 50%, less than 25%, less than 20%, or less than 10% relative to the outer diameter of the inner member 103 or relative to the inner diameters of the inserting segments.

[0076] In some bent configurations, a portion of the inner member 103 may contact one or more inserted cylindrical segments 126. However, the inner member 103 is prevented from further radial movement toward the material (e.g., the balloon material) of the segmented balloons B1, B2, B3, and B4, and is instead pushed into a more compact, more curvature bent configuration than when the inserted cylindrical segments 126, 134, and 142 are not present. Thus, the inserted cylindrical segments 126, 134, and 142 function to, when the segmented balloon system 100 is in a bent configuration, to space the electrode pairs (multiples) from the balloon material by preventing or limiting the positional displacement of the inner member 103 and the associated electrode pairs or other lithotripsy emitters E1 to E4 relative to the balloon material, and to prevent one or more electrode pairs or other lithotripsy emitters E1 to E4 from damaging the segmented balloons B1 to B4 during arc discharge or other acoustic shock wave generation.

[0077] As technicians will understand Figure 4 and Figure 5 The segmented balloon system 100 is not limited to the illustrated four-segment balloon system. For example, in combination with... Figure 4 and Figure 5 The described system can be readily implemented using a segmented balloon system comprising two or more segmented balloons (e.g., 2, 3, 4, 5, 6 or more). For example, as Figure 6 As shown, the segmented balloon system 200 has two segmented balloons, a proximal segmented balloon B1' and a distal segmented balloon B2', separated by a single inserted cylindrical segment 126'. An internal component 103 is configured to pass through the system 200 and support at least one electrode or other lithotripsy emitter E1', E2' within each segmented balloon B1' and B2'. The structure, features, and functions of the elements indicated by apostrophes following the numbers are related to their combination. Figure 4 and Figure 5The components with the corresponding numbers described are identical. Therefore, the segmented balloon system of the above embodiments may include at least two segmented balloons and at least one inserted cylindrical segment.

[0078] In some embodiments, the inserted cylindrical segments may include a balloon material that is more rigid than adjacent segmented balloons to further help prevent the inner member 103 and associated electrodes or other lithotripsy emitters from shifting to one side of the segmented balloon when in a bent configuration. For example, the inserted segments may include a material that is harder than adjacent balloon segments (e.g., having a higher Shore A hardness). In one embodiment, they may include a rigid material (e.g., instead of an elastomeric material).

[0079] Now go to Figure 7 and Figure 8 The present invention provides an exemplary embodiment of a specific embodiment of the inner member 103. The function of the segmented balloon system discussed above is to prevent or minimize positional displacement of the inner member 103 toward one or more segments of the balloon when in a flexed configuration.

[0080] Figure 7 and Figure 8 An additional positional displacement prevention mechanism is provided within the structure of the inner member 103 by using regions of relative increase and decrease in flexibility within the segmented balloon(s). Figure 7 and Figure 8 A non-limiting example of the internal component 103 is illustrated, comprising a two-electrode pair structure (or other lithotripter). The principles discussed below apply at least to internal components 103 comprising two or more electrode pairs or other lithotripters spaced longitudinally apart from each other, and / or including such... Figure 3 The illustrated balloon may be one or more balloons comprising two or more segmented balloon structures disclosed herein.

[0081] Figure 7 An exemplary internal component 103' is provided, which can be used to improve, for example... Figure 3 The balloon shown, or related to Figures 4 to 6Any of the exemplary segmented balloon embodiments shown are used in combination. Thus, a first region 150 comprising a relatively flexible material is provided along the inner member 103' from proximal to distal, and the first region 150 is formed of, for example, a polyether block amide (PEBAX) thermoplastic elastomer material. A marking band is located within the first region 150 of the relatively flexible material. Adjacent distally to the first region 150 of the relatively flexible material is a second region 152 comprising a material with higher rigidity (relative to the first region 150), which may include polyimide or other similar materials that are more rigid and less flexible than the material of the first region 150. Adjacent distally to the second region 152 is a third region 154 (e.g., an intermediate region) comprising a material with higher relative flexibility and lower rigidity, which may include the same material as the first region 150. Adjacent distally to the third region is a fourth region 156 comprising a material with higher relative rigidity and lower flexibility, and which may include the same material as the second region 152. Adjacent to the distal side of the fourth region 156 is a fifth region 158, which is a material with relatively higher flexibility and lower rigidity. This fifth region may comprise the same material as the first region 150 and / or the third (e.g., intermediate) region 154. The Shore A hardness values ​​of the materials in the more rigid regions 152 and 156 may be greater than those of the materials in the less rigid, more flexible regions 150, 154, and 158. In another embodiment, the Young's modulus values ​​of the materials in the more rigid regions 152 and 156 may be greater than those of the materials in the less rigid, more flexible regions 150, 154, and 158.

[0082] The first electrode or other lithotripter E1' is shown as located on the inner member 103' within a second region 152 with higher rigidity. The second electrode or other lithotripter E2' is shown as located on the inner member 103' within a fourth region 156 with higher rigidity. A third region of material with relatively high flexibility and low rigidity is interposed between the two electrodes or other lithotripter E1' and E2'. If the lithotripter includes a laser, only a single lithotripter may exist (e.g., while if the lithotripter is an electrode, there are typically at least two spaced electrodes to generate a plasma arc between the two spaced electrodes).

[0083] Therefore, in Figure 6In the two segmented balloon embodiments, mounting or positioning the electrodes or other lithotripsy emitters E1' and E2' within the second region 152 and the fourth region 156, respectively, helps to eliminate the positional displacement of the inner member 103 within the regions 152, 156 where the electrodes E1' and E2' are located when the inner member is in a bent position by making the second region 152 and the fourth region 156 less prone to buckling. Therefore, the radial movement of the electrodes E1' and E2' is restricted, and they are thus better held or spaced apart from the surface of the balloon.

[0084] Generally, the radius of the curved inner member 103 and the segmented balloon structure described above can be configured in a curved manner, wherein the radius of the inner member 103 and the radius of the segmented balloon structure surrounding the inner member 103 are substantially the same. This is consistent with... Figure 3 In contrast to known devices, in which the radius of the balloon is typically larger than the radius of the inner member 13, causing the inner member 12 and the associated electrode pair E to bend radially outward toward the balloon material.

[0085] Figure 8 Another embodiment of the inner component 103'' is illustrated, which can be used to improve existing balloons (such as...) Figure 3 The system, or embodiments thereof including segmented balloon systems described herein, is used to minimize and / or prevent positional displacement of the inner member and associated electrodes relative to the surrounding balloon surface when in a bent configuration. Thus, a first region 160 with increased flexibility is provided along the inner member 103'' from the proximal direction to the distal direction, and the first region 160 may comprise a PEBAX material. Adjacent distally to the first region 160 is a second region 162 with relatively lower flexibility and increased rigidity relative to the first region 160. Adjacent distally to the second region 162 is a third region 164 with increased flexibility, which may comprise the same or similar flexible material as the first region 160.

[0086] The inner member 103'' is shown as including at least two electrode pairs E1'' and E2'' (or other rock-blasting emitters) located along the inner member 103'' within a second region 162 of increased rigidity.

[0087] and Figure 7 Similarly, placing electrode pairs E1'' and E2'' or other lithotripter(s) in a more rigid second region 162 helps to eliminate the positional displacement of the inner member 103 in the second region 162 when the inner member is in a bent position by making the second region 162 less prone to buckling. Therefore, the radial movement of electrodes E1'' and E2'' (or other lithotripter(s) in this region) is restricted and better kept away from the surface of the balloon.

[0088] Because the second region 162 holds two pairs of electrodes E1'' and E2'' (or includes any other type of lithotripsy emitter that may be used), a single balloon can be used, for example, any one of the various IVL balloons that a person skilled in the art will understand in accordance with this disclosure. Alternatively, a two-segment balloon system as described above can also be used, wherein each electrode E1'' and E2'' (or other lithotripsy emitter) is located within a segmented balloon positioned adjacent to itself, and has as described above in, for example Figures 4 to 6 The inserted cylindrical segment described in any of the diagrams.

[0089] Figure 7 and Figure 8 The inner components 103' and 103'' can be implemented individually, for example, together with any desired lithotripsy balloon, or in combination with embodiments of the segmented balloon described herein, to minimize and / or prevent positional displacement of the inner components and associated electrodes relative to the surrounding balloon surface when in a flexural configuration. The better the electrodes are spaced from the balloon surface, the less likely the balloon surface will be damaged by the generated plasma arc. Similar benefits are achieved when using other lithotripsy emitters (e.g., lasers) configured to generate shock waves, because the plasma generated by the laser and the accompanying shock wave can damage the balloon surface in a manner similar to that caused by a plasma arc discharge and associated shock wave generated by a pair of spaced-apart electrodes.

[0090] As for the above combination Figure 7 In the described embodiment, the Shore A hardness value of the material in the higher rigidity region 162 can be greater than the Shore A hardness value of the material in the lower rigidity and higher flexibility regions 160 and 164. In another embodiment, the Young's modulus value of the material in the higher rigidity region 162 can be greater than the Young's modulus value of the material in the lower rigidity and higher flexibility regions 160 and 164.

[0091] Figure 7 and Figure 8 The elongated members 103' and 103'' may include at least the following non-limiting examples 1 and 2.

[0092] Example 1 (for example, such as) Figure 7 (As shown): A catheter for use in an intravascular lithotripsy (“IVL”) system or other lithotripsy systems, comprising:

[0093] An elongated member, the elongated member comprising:

[0094] A distal region, the distal region being disposed along the distal portion of the elongated member, and

[0095] One or more pairs of regions, which are longitudinally spaced from each other and disposed along a portion of the elongated member proximal to the distal region, wherein each pair of regions is longitudinally spaced from each other by an intermediate region.

[0096] The distal region and the intermediate region are more flexible than the pair or more pairs of regions.

[0097] Example 2 (for example, such as) Figure 8 (As shown): A catheter for use in an intravascular lithotripsy (“IVL”) system or other lithotripsy systems, comprising:

[0098] An elongated member, the elongated member comprising a fluid-inflatable balloon, and

[0099] Alternating flexible regions, which are located within the fluid-inflatable balloon along the elongated member.

[0100] The alternating flexible regions include at least one region configured to support at least a pair of spaced-apart electrodes or another rock-crushing emitter, wherein the flexibility of the at least one region is less than the flexibility of the remaining alternating flexible regions.

[0101] Furthermore, embodiments of the elongated members 103' and 103'' can be combined with embodiments described herein that include segmented balloons, for example, as in the following non-limiting exemplary example 3.

[0102] Example 3: A segmented balloon system for use in an intravascular lithotripsy (“IVL”) system or other lithotripsy systems, comprising:

[0103] The catheter in Example 1 or 2;

[0104] Two or more segmented balloons are configured to surround a portion of the elongated member in a watertight manner, each of the two or more segmented balloons being longitudinally spaced from adjacent segmented balloons or shells by an insertion segment having an outer diameter upon inflatation;

[0105] Each segmented balloon in the segmented balloon includes a conical proximal segment, a central cylindrical segment, and a conical distal segment. The outer diameter of the central cylindrical segment during inflation is larger than the outer diameter of the insertion segment during inflation.

[0106] Non-limiting segmented balloon embodiments may also include non-limiting exemplary examples 4 and 5:

[0107] Example 4: A segmented balloon system for use in an intravascular lithotripsy (“IVL”) system or other lithotripsy system, comprising:

[0108] Slender components;

[0109] Two or more segmented balloons are configured to surround a portion of the elongated member in a watertight manner, each of the two or more segmented balloons being longitudinally spaced from adjacent segmented balloons or shells by an insertion segment having an outer diameter upon inflatation;

[0110] Each segmented balloon in the segmented balloon includes a conical proximal segment, a central cylindrical segment, and a conical distal segment. The outer diameter of the central cylindrical segment during inflation is larger than the outer diameter of the insertion segment during inflation.

[0111] Example 5: A segmented balloon system for use in an intravascular lithotripsy (“IVL”) system or other lithotripsy systems, comprising:

[0112] Slender components;

[0113] An outer member, the outer member including a lumen and configured to receive the elongated member therein;

[0114] Two or more segmented balloons are configured to surround a portion of the elongated member in a watertight manner at the distal end and at the proximal end, each of the two or more segmented balloons being longitudinally spaced from the adjacent segmented balloon or shell by an insertion segment having an outer diameter upon inflatation;

[0115] Each segmented balloon in the segmented balloon includes a conical proximal segment, a central cylindrical segment, and a conical distal segment. The outer diameter of the central cylindrical segment during inflation is larger than the outer diameter of the insertion segment during inflation.

[0116] The articles “a,” “an,” and “the” are intended to mean the presence of one or more of the elements described above. The terms “comprising,” “including,” and “having” are intended to be inclusive and mean that additional elements may be present in addition to those listed. Furthermore, it should be understood that references to “one embodiment” or “an embodiment” in this disclosure are not intended to exclude the existence of additional embodiments that also include the described features. The numbers, percentages, ratios, or other values ​​stated herein are intended to include those values ​​as well as other values ​​that are “about” or “approximate” to the stated values, as will be understood by one of ordinary skill in the art to which embodiments of this disclosure are covered. Therefore, the stated values ​​should be interpreted broadly enough to cover values ​​that are at least close enough to the stated values ​​to perform the desired function or achieve the desired result. The stated values ​​include at least the variations expected in a suitable manufacturing or production process and may include values ​​within 5%, 1%, 0.1%, or 0.01% of the stated values.

[0117] Those skilled in the art will recognize from this disclosure that equivalent constructions do not depart from the spirit and scope of this disclosure, and that various modifications, substitutions, and variations can be made to the embodiments disclosed herein without departing from the spirit and scope of this disclosure. Equivalent constructions including functional "means-plus-function" clauses are intended to cover structures described herein that perform the recited functions, including structural equivalents that operate in the same manner and equivalent structures that provide the same functionality. The applicant's explicit intent is that no means-plus-function or other functional claims are invoked against any claim except those claims where the phrase "means for..." appears with the associated function. Any additions, deletions, and modifications to the embodiments will be included in the claims as long as they fall within the meaning and scope of the claims.

[0118] As used herein, the terms “approximately,” “about,” and “substantially” mean a quantity that is close to the stated quantity, but which still performs the desired function or achieves the desired result. For example, the terms “approximately,” “about,” and “substantially” can refer to a quantity that is less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated quantity. Furthermore, it should be understood that any direction or frame of reference described above is only relative direction or motion. For example, any reference to “up” and “down,” or “above” or “below”, is only a description of the relative position or motion of the relevant element.

[0119] Any scope disclosed herein includes any and all overlapping portions, subscopes, and combinations thereof. Additional scopes may be defined within any values ​​provided herein, and such additional scopes are within the scope of this disclosure. Words such as “up to,” “at least,” “greater than,” “less than,” “between,” etc., include the numbers(s) recorded.

[0120] The following are some other exemplary embodiments of the present invention. These other exemplary embodiments are presented merely as examples and are not intended to limit the scope of the invention in any way. Furthermore, any exemplary embodiment may be combined with one or more exemplary embodiments.

[0121] Example 1. A catheter for use in an intravascular lithotripsy (“IVL”) system or other lithotripsy systems, comprising:

[0122] An elongated member, the elongated member comprising a fluid-inflatable balloon; and

[0123] Alternating flexible regions, which are located within the fluid-inflatable balloon along the elongated member;

[0124] The alternating flexible regions include at least one region configured to support at least one gravel launcher, wherein the flexibility of the at least one region is less than the flexibility of the remaining alternating flexible regions.

[0125] Example 2. The catheter according to Example 1, wherein the at least one lithotripter includes at least a pair of spaced-apart electrodes, or a laser.

[0126] Example 3. The catheter according to Example 1, wherein the at least one region is disposed along the elongated member at a position distal to and adjacent to an alternating flexible region having a greater flexibility than the at least one region, and wherein the at least one region is disposed along the elongated member at a position proximal to and adjacent to an alternating flexible region having a greater flexibility than the at least one region.

[0127] Example 4. The catheter according to Example 3, wherein the at least one region comprises two regions, the two regions being longitudinally spaced apart from each other by alternating flexible regions, the flexibility of the alternating flexible regions being greater than the flexibility of the two regions.

[0128] Example 5. The catheter according to Example 3, wherein the at least one region comprises three regions, each of the three regions being longitudinally spaced apart from each other by alternating flexible regions, the flexibility of the alternating flexible regions being greater than the flexibility of the three regions.

[0129] Example 6. The catheter according to Example 3, wherein the at least one region comprises four regions, each of the four regions being longitudinally spaced apart from each other by alternating flexible regions, the flexibility of the alternating flexible regions being greater than the flexibility of the four regions.

[0130] Example 7. The catheter according to Example 3, wherein the at least one region comprises five regions, each of the five regions being longitudinally spaced from each other by alternating flexible regions, the flexibility of the alternating flexible regions being greater than the flexibility of the five regions.

[0131] Example 8. The catheter according to Example 4, wherein the fluid-inflatable balloon surrounds at least the two regions.

[0132] Example 9. The catheter according to Example 5, wherein the fluid-inflatable balloon surrounds at least the three regions.

[0133] Example 10. The catheter according to Example 6, wherein the fluid-inflatable balloon surrounds at least the four regions.

[0134] Example 11. The catheter according to Example 7, wherein the fluid-inflatable balloon surrounds at least the five regions.

[0135] Example 12. The catheter according to Example 8, wherein the fluid-inflatable balloon is configured to surround at least a portion of the remaining alternating flexible regions.

[0136] Example 13. A catheter for use in an intravascular lithotripsy (“IVL”) system or other lithotripsy system, comprising:

[0137] An elongated member, the elongated member comprising:

[0138] A distal region, the distal region being disposed along the distal portion of the elongated member, and

[0139] One or more pairs of regions, the one or more pairs of regions being longitudinally spaced apart from each other and disposed along a portion of the elongated member proximal to the distal region, wherein each pair of regions is longitudinally spaced apart from each other by an intermediate region.

[0140] The distal region and the intermediate region are more flexible than the pair or more pairs of regions.

[0141] Example 14. The catheter according to Example 13 further includes one or more lithotripsy emitters disposed along the elongated member in each of the one or more pairs of regions.

[0142] Example 15. The catheter according to Example 14, wherein the one or more lithotripsy emitters comprise one or more pairs of spaced-apart electrodes, or lasers.

[0143] Example 16. The catheter according to Example 13 further includes a fluid-inflatable balloon configured to surround the pair or more pairs of regions and each intermediate region.

[0144] Example 17. The catheter according to Example 16, wherein the fluid-inflatable balloon surrounds at least a portion of the one or more pairs of regions located proximal to the distal region.

[0145] Example 18. A segmented balloon system for use in an intravascular lithotripsy (“IVL”) system or other lithotripsy systems, comprising:

[0146] Slender components; and

[0147] Two or more segmented balloons are configured to surround a portion of the elongated member in a watertight manner, each of the two or more segmented balloons being longitudinally spaced from adjacent segmented balloons or shells by an insertion segment having an outer diameter upon inflatation;

[0148] Each segmented balloon in the segmented balloon includes a conical proximal segment, a central cylindrical segment, and a conical distal segment. The outer diameter of the central cylindrical segment during inflation is larger than the outer diameter of the insertion segment during inflation.

[0149] Example 19. The segmented balloon system according to Example 18, wherein the two or more segmented balloons are configured to be in fluid communication with each other.

[0150] Example 20. The segmented balloon system according to Example 19, wherein when the segmented balloon system is bent or folded, the elongated member engages or contacts at least one insertion segment.

[0151] Example 21. A segmented balloon system according to Example 20, wherein each insertion segment engaging with the elongated member is configured to space the elongated member from the inner surfaces of the two or more segmented balloons.

[0152] Example 22. The segmented balloon system according to Example 21 further includes (i) one or more pairs of spaced-apart electrodes, or (ii) other lithotripsy emitters, associated with the elongated member and located within each of the two or more segmented balloons.

[0153] Example 23. A segmented balloon system for use in an intravascular lithotripsy (“IVL”) system or other lithotripsy systems, comprising:

[0154] The catheter according to any one of Examples 1 to 17; and

[0155] Two or more segmented balloons are configured to surround a portion of the elongated member in a watertight manner, each of the two or more segmented balloons being longitudinally spaced from adjacent segmented balloons or shells by an insertion segment having an outer diameter upon inflatation;

[0156] Each segmented balloon in the segmented balloon includes a conical proximal segment, a central cylindrical segment, and a conical distal segment. The outer diameter of the central cylindrical segment during inflation is larger than the outer diameter of the insertion segment during inflation.

[0157] Example 24. The segmented balloon system according to Example 23, wherein each of the two or more segmented balloons is configured to surround the at least one region configured to support at least one lithotripter.

[0158] Example 25. The segmented balloon system according to Example 24, wherein the elongated member further includes a flexible region, the flexibility of which is greater than the flexibility of the at least one region configured to support at least one lithotripter, wherein the flexible region is surrounded by the insertion segment.

[0159] Example 26. A segmented balloon system for use in an intravascular lithotripsy (“IVL”) system or other lithotripsy systems, comprising:

[0160] Slender components;

[0161] An outer member, the outer member including a lumen and configured to receive the elongated member therein; and

[0162] Two or more segmented balloons are configured to surround a portion of the elongated member in a watertight manner at the distal end and at the proximal end, each of the two or more segmented balloons being longitudinally spaced from the adjacent segmented balloon or shell by an insertion segment having an outer diameter upon inflatation;

[0163] Each segmented balloon in the segmented balloon includes a conical proximal segment, a central cylindrical segment, and a conical distal segment. The outer diameter of the central cylindrical segment during inflation is larger than the outer diameter of the insertion segment during inflation.

[0164] Example 27. The segmented balloon system according to Example 26, wherein the two or more segmented balloons are configured to be in fluid communication with each other.

[0165] Example 28. The segmented balloon system according to Example 26, wherein when the segmented balloon system is bent or folded, the elongated member engages or contacts at least one insertion segment.

[0166] Example 29. The segmented balloon system according to Example 28, wherein each insertion segment engaging with the elongated member is configured to space the elongated member from the inner surfaces of the two or more segmented balloons.

[0167] Example 30. A method for treating intravascular lesions using a catheter according to one or more of Examples 1 to 17.

[0168] Example 31. A method for treating intravascular lesions using a segmented balloon system according to one or more of Examples 18 to 29.

[0169] The invention may be implemented in other specific forms without departing from the spirit or essential characteristics thereof. The described embodiments are to be regarded in all respects as illustrative rather than restrictive. Therefore, the scope of the invention is indicated by the appended claims, not by the foregoing description. All modifications falling within the equivalent meaning and scope of the claims are to be included within the scope of the claims.

Claims

1. A catheter for use in an intravascular lithotripsy ("IVL") system or other lithotripsy system, comprising: An elongated member, said elongated member comprising a fluid-inflatable balloon; as well as Alternating flexible regions, which are located within the fluid-inflatable balloon along the elongated member; The alternating flexible regions include at least one region configured to support at least one gravel launcher, wherein the flexibility of the at least one region is less than the flexibility of the remaining alternating flexible regions.

2. The catheter of claim 1, wherein, The at least one rock-crushing emitter includes at least a pair of spaced-apart electrodes, or a laser.

3. The catheter of claim 1, wherein, The at least one region is disposed along the elongated member at a position distal to and adjacent to an alternating flexible region having a greater flexibility than the at least one region, and wherein the at least one region is disposed along the elongated member at a position proximal to and adjacent to an alternating flexible region having a greater flexibility than the at least one region.

4. The catheter of claim 3, wherein, The at least one region includes two regions that are longitudinally separated from each other by alternating flexible regions, wherein the flexibility of the alternating flexible regions is greater than the flexibility of the two regions.

5. The catheter of claim 3, wherein, The at least one region comprises three regions, each of which is longitudinally spaced from each other by alternating flexible regions, the flexibility of which is greater than that of the three regions.

6. The catheter of claim 3, wherein, The at least one region comprises four regions, each of which is longitudinally spaced from each other by alternating flexible regions, the flexibility of which is greater than that of the four regions.

7. The catheter of claim 3, wherein, The at least one region comprises five regions, each of which is longitudinally spaced from each other by alternating flexible regions, the flexibility of which is greater than that of the five regions.

8. The catheter of claim 4, wherein, The fluid-inflatable balloon surrounds at least the two regions.

9. The catheter of claim 5, wherein, The fluid-inflatable balloon surrounds at least the three regions.

10. The catheter of claim 6, wherein, The fluid-inflatable balloon surrounds at least the four regions.

11. The catheter of claim 7, wherein, The fluid-inflatable balloon surrounds at least the five regions.

12. The catheter of claim 8, wherein, The fluid-inflatable balloon is configured to surround at least a portion of the remaining alternating flexible regions.

13. A catheter for use in an intravascular lithotripsy ("IVL") system or other lithotripsy system, comprising: An elongated member, the elongated member comprising: A distal region, the distal region being disposed along the distal portion of the elongated member, and One or more pairs of regions, the one or more pairs of regions being longitudinally spaced apart from each other and disposed along a portion of the elongated member proximal to the distal region, wherein each pair of regions is longitudinally spaced apart from each other by an intermediate region. The distal region and the intermediate region are more flexible than the pair or more pairs of regions.

14. The catheter of claim 13, further comprising one or more lithotripsy emitters disposed along the elongated member in each of the one or more pairs of regions.

15. The catheter of claim 14, wherein, The one or more rock-crushing emitters include one or more pairs of spaced-apart electrodes, or lasers.

16. The catheter of claim 13, further comprising a fluid-inflatable balloon configured to surround the one or more pairs of regions and each intermediate region.

17. The catheter of claim 16, wherein, The fluid-inflatable balloon surrounds at least a portion of the one or more pairs of regions proximal to the distal end region.

18. A segmented balloon system for an intravascular lithotripsy ("IVL") system or other lithotripsy system, comprising: an elongated member; and two or more segmented balloons configured to surround a portion of the elongated member in watertight association with the elongated member, each of the two or more segmented balloons being longitudinally spaced from an adjacent segmented balloon or housing by an interposed segment having an outer diameter when inflated; wherein each of the segmented balloons comprises a tapered proximal segment, a central cylindrical segment, and a tapered distal segment, the central cylindrical segment having an outer diameter when inflated that is greater than the outer diameter of the interposed segment when inflated.

19. The segmented balloon system of claim 18, wherein, The two or more segmented balloons are configured to be in fluid communication with each other.

20. The segmented balloon system of claim 19, wherein, The elongated member engages or contacts at least one interposed segment when the segmented balloon system is bent or kinked.

21. The segmented balloon system of claim 20, wherein, Each interposed segment that engages the elongated member is configured to space the elongated member from an inner surface of the two or more segmented balloons.

22. The segmented balloon system of claim 21, further comprising (i) one or more pairs of spaced-apart electrodes, or (ii) other lithotripsy emitters, associated with the elongated member and within each of the two or more segmented balloons.

23. A segmented balloon system for an intravascular lithotripsy ("IVL") system or other lithotripsy system, comprising: the catheter of any one of claims 1-17; and two or more segmented balloons configured to surround a portion of the elongated member in watertight association with the elongated member, each of the two or more segmented balloons being longitudinally spaced from an adjacent segmented balloon or housing by an interposed segment having an outer diameter when inflated; wherein each of the segmented balloons comprises a tapered proximal segment, a central cylindrical segment, and a tapered distal segment, the central cylindrical segment having an outer diameter when inflated that is greater than the outer diameter of the interposed segment when inflated.

24. The segmented balloon system of claim 23, wherein, Each of the two or more segmented balloons is configured to surround the at least one region configured to support at least one lithotripsy emitter.

25. The segmented balloon system of claim 24, wherein, The elongated member further comprises a flexible region having a flexibility that is greater than a flexibility of the at least one region configured to support at least one lithotripsy emitter, wherein the flexible region is surrounded by the interposed segment.

26. A segmented balloon system for an intravascular lithotripsy ("IVL") system or other lithotripsy system, comprising: an elongated member; an outer member comprising a lumen and configured to receive the elongated member therein; and two or more segmented balloons configured to surround a portion of the elongated member in watertight association with the elongated member at a distal end and with the outer member at a proximal end, each of the two or more segmented balloons being longitudinally spaced from an adjacent segmented balloon or outer shell by an interposed segment having an outer diameter when inflated; wherein each of the segmented balloons includes a tapered proximal segment, a central cylindrical segment, and a tapered distal segment, the central cylindrical segment having an outer diameter when inflated that is greater than the outer diameter of the interposed segment when inflated.

27. The segmented balloon system of claim 26, wherein, the two or more segmented balloons are configured to be in fluid communication with one another.

28. The segmented balloon system of claim 26, wherein, the elongated member engages or contacts at least one interposed segment when the segmented balloon system is bent or kinked.

29. The segmented balloon system of claim 28, wherein, each interposed segment that engages the elongated member is configured to space the elongated member from an inner surface of the two or more segmented balloons.

30. A method of treating an endovascular lesion using the catheter of one or more of claims 1 to 17.

31. A method of treating an endovascular lesion using the segmented balloon system of one or more of claims 18 to 29.

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