Intravascular lithotripsy catheter

Abstract

The medical device catheter includes a catheter shaft having a proximal end for remaining outside the patient's body, a distal end for insertion into the body, and a first longitudinal centerline axis. At the distal end, a cavitation bubble chamber is located along a second longitudinal centerline axis. The catheter includes a cavitation solution lumen at the proximal end, which communicates with the cavitation bubble chamber and a corresponding solution fitting. Additionally, a conductor and electrode gap within the cavitation bubble chamber and a guidewire lumen having a third longitudinal centerline axis are located, where each of the first, second, and third longitudinal centerline axes are offset from one another to enable targeted medical procedures, such as lithotripsy, while ensuring a compact catheter design and robust performance, even at high voltages.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of U.S. Patent Application No. 18 / 241,720, filed September 1, 2023, which is a continuation-in-part of U.S. Patent Application No. 18 / 144,208, filed May 7, 2023, which is a continuation-in-part of U.S. Patent Application No. 18 / 095,992, filed January 11, 2023 (which claims the benefit of U.S. Provisional Patent Application No. 63 / 298,282, filed January 11, 2022), the entire contents of which are hereby incorporated by reference herein. [Background technology]

[0002] The present disclosure relates generally to the design of medical devices for use within the body, and more particularly to catheters such as intravascular lithotripsy catheters.

[0003] Catheter-type devices are typically long, tubular structures with a lumen suitable for a guidewire used to navigate the vasculature, inject contrast or therapeutic materials, aspirate blood clots, or provide a means for delivering other devices or therapies to a target site within the vasculature or other body cavity. Catheter-type devices are typically inserted through a small opening in the skin or another opening under visual guidance and tracked to a target location within the body. Catheters for minimally invasive procedures are typically integrated, unitary structures that combine structural, therapeutic, and diagnostic elements at the distal end of the catheter.

[0004] U.S. Patent Application Publication No. 2007 / 0244440 discloses a medical device including a catheter with an expandable tip for use with at least two different sized wire guides. The catheter includes a wire guide lumen sized to receive a first wire guide of a first diameter. The catheter may also include a tip lumen extending distally from a first opening to a second opening that communicates with the wire guide lumen. The first opening is sized to receive the first wire guide, and the second opening is sized to receive a second wire guide of a smaller diameter than the first wire guide. The catheter also includes one or more longitudinal expansion features that can radially expand the tip lumen to receive a wire guide of a diameter up to the first diameter through the second opening.

[0005] U.S. Patent No. 8,100,884 discloses an adapter assembly for connecting a catheter assembly to a tunneler having a generally tubular body having a first end, a second end, and a longitudinal axis extending therethrough. The first end of the adapter is configured to engage with the proximal end of a trocar. The second end of the adapter is configured to releasably engage with at least one catheter lumen. A slider is disposed around the adapter and is longitudinally slidable along the adapter. When the slider slides toward the second end of the adapter, the slider engages with multiple legs on the adapter, deflecting the multiple legs toward each other and toward the longitudinal axis of the adapter.

[0006] U.S. Patent No. 8,523,840 discloses a coupler assembly for use with a catheter to connect the proximal end of the catheter to an extracorporeal medical device. An exemplary coupler assembly includes a spherical linkage coupler for a catheter. The coupler includes a first cylindrical portion for connecting to a structure and a second cylindrical portion for connecting to the distal end of the catheter body. The coupler also includes a spherical linkage including at least two link arms. Each of the two link arms is connected on one end to the first cylindrical portion and on the other end to the second cylindrical portion. The two link arms connect a portion of the structure to the distal end of the catheter and allow the structure to move relative to the distal end of the catheter in response to an external force applied to the structure.

[0007] U.S. Patent Nos. 9,282,991, 9,808,276, 7,976,557, and U.S. Patent Application Publication No. 2006 / 0259005 describe variations on methods for delivering therapeutic agents, such as drugs, using cutting balloons in which the cutting or galling members may include a therapeutic agent coated thereon, the cutting or galling members being integrated into the structure of the balloon and catheter system itself.

[0008] U.S. Patent Application Publication No. 2008 / 0275427 describes a catheter connection system for connecting catheter tubes together to form a secure, leak-tight connection. As described, the connection system includes a threaded connector inserted into the end of a catheter lumen, with the interior portion of the catheter lumen resiliently conforming to match the threaded configuration of the connector.

[0009] U.S. Patent No. 8,956,371 describes a shock wave balloon catheter system that uses shock waves generated inside the inflatable balloon of an angioplasty balloon catheter to help treat vascular lesions that block blood vessels. The shock waves can help destroy calcium deposits in these vascular lesions. Similar shock wave technology is used in lithotripsy medical devices to help break up kidney stones within the body, as described, for example, in U.S. Patent No. 5,047,685.

[0010] It would be desirable to provide improved adapters and modular systems designed with features that extend, enhance, or modify the configuration or intended use of a medical device or parent module, such as by providing lithotripsy functionality, where the adapter includes geometric, mechanical, and / or thermal properties for rapid attachment to a medical device, such as a catheter.

[0011] Alternatively, it would be desirable to provide an improved catheter designed with useful features, including lithotripsy functionality, whether as part of a modular system or as a unitary design, for example. Summary of the Invention

[0012] This Summary is provided to introduce a selection of concepts that are further described below in the Detailed Description of the Invention. This Summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used as an aid in limiting the scope of the claimed subject matter.

[0013] In one aspect, a medical device catheter includes a cavitation bubble chamber configured to contain a cavitation solution, and at least two electrodes positioned within the cavitation bubble chamber to contact the cavitation solution and form an electrode gap. The proximal end of the medical device catheter is adapted to remain outside the patient's body during use of the catheter, and a first lumen is in fluid communication with the cavitation bubble chamber and the proximal end and configured to deliver the cavitation solution from the proximal end of the medical device catheter to the cavitation bubble chamber. The at least two electrodes are configured to generate a spark or arc across the electrodes when energized by a high-voltage pulse generator, creating shock waves and cavitation bubbles.

[0014] In another aspect, a medical device catheter includes a first tube including a first cavitation solution lumen having a distal opening, a second tube containing the first tube and including a cavitation bubble chamber, a second cavitation solution lumen in fluid communication with the first cavitation solution lumen through the distal opening, and a distal plug at the distal end of the cavitation bubble chamber to create a distal boundary of the cavitation bubble chamber. A proximal rapid-exchange guidewire outlet is positioned distal to the distal boundary of the cavitation bubble chamber and in communication with the guidewire lumen, and a first powered electrode extends through the first tube and first cavitation solution lumen and the cavitation bubble chamber, and into the distal plug beyond the distal boundary of the cavitation bubble chamber.

[0015] In another aspect, a medical device catheter includes a proximal end for remaining outside a patient's body, a distal end for insertion, and a catheter shaft having a first longitudinal centerline axis. At the distal end, a cavitation bubble chamber is present along a second longitudinal centerline axis. The catheter includes a cavitation solution lumen in communication with the cavitation bubble chamber and a corresponding solution fitting at the proximal end. Additionally, the cavitation bubble chamber includes a conductor and electrode gap, and a guidewire lumen having a third longitudinal centerline axis, where each of the first, second, and third longitudinal centerline axes are offset from one another to enable targeted medical procedures, such as lithotripsy, while ensuring a compact catheter design and robust performance at high voltages. [Brief explanation of the drawings]

[0016] [Figure 1] 1 is a schematic perspective view of an adapter according to the present disclosure; [Figure 2] 1, showing a portion of the distal portion of the adapter, the attachment mechanism, and other features. [Figure 3] 1 showing the proximal end of the adapter, including the electrical connector; [Figure 4] FIG. 2 is a partial schematic cross-sectional view CS1 of the adapter of FIG. [Figure 5] CS2 is a partial schematic cross-sectional view of the adapter of FIG. 1. [Figure 6A] 1 is a partial schematic perspective view of a parent balloon catheter before an adapter is attached to the distal end of the parent balloon catheter, the inflatable balloon being shown as inflated for illustrative purposes. FIG. [Figure 6B] 1 is a partial schematic perspective view of an adapter according to the present disclosure attached to the distal end of a balloon catheter, the inflatable balloon being shown as inflated for illustrative purposes; FIG. [Figure 7]1 is a schematic perspective view of an adapter according to the present disclosure attached to the distal end of a balloon catheter and a proximal electrical modular interface attached to the proximal end to form an electrical modular catheter system, the balloon being shown as inflated for illustrative purposes; [Figure 8] 1 is a schematic perspective view of an adapter according to the present disclosure; [Figure 9] 9 is an enlarged detail view of FIG. 8 showing a portion of the distal portion of the adapter, the attachment mechanism, and other features. [Figure 10] FIG. 9 is an enlarged detail view of FIG. 8 showing the internal features and elements of the distal portion of the adapter. [Figure 11] 1 is a partial schematic longitudinal cross-sectional view of an adapter according to the present disclosure;Break line marks are utilized to reduce the size of the drawings for clarity; [Figure 12] FIG. 12 is a partial schematic cross-sectional view CS3 of the adapter of FIG. 11. [Figure 13] FIG. 12 is a partial schematic cross-sectional view CS4 of the adapter of FIG. 11. [Figure 14] FIG. 12 is a partial schematic cross-sectional view CS5 of the adapter of FIG. 11. [Figure 15] FIG. 9 is an enlarged detail view of FIG. 8 showing the internal features and elements of the distal portion of the adapter. [Figure 16] FIG. 1 is a schematic perspective view of an adapter according to one embodiment of the present disclosure. [Figure 17] FIG. 17 is an enlarged detail view of FIG. 16 showing a portion of the distal portion of the adapter, the attachment mechanism, and other features. [Figure 18] 1 is a partial schematic perspective view of an adapter according to the present disclosure attached to the distal end of a balloon catheter, the balloon being shown as inflated for illustrative purposes; [Figure 19] 1 is a partial schematic longitudinal cross-sectional view of an adapter according to the present disclosure;Break line marks are utilized to reduce the size of the drawings for clarity; [Figure 20] FIG. 20 is a partial schematic cross-sectional view CS6 of the adapter of FIG. 19. [Figure 21]FIG. 20 is a partial schematic cross-sectional view CS7 of the adapter of FIG. 19. [Figure 22] 1 is an example of a wiring schematic for use with an adapter according to the present disclosure. [Figure 23] 10 is an example of another wiring schematic for use with an adapter according to the present disclosure. [Figure 24] 1 is an alternative electrode configuration according to the present disclosure. [Figure 25] FIG. 25 is a partial schematic cross-sectional view CS8 of the adapter of FIG. 24. [Figure 26] 1 is a partial schematic perspective view of an adapter according to the present disclosure; [Figure 27] 1 is a partial schematic longitudinal cross-sectional view with partial cutaway of an alternative electrode configuration according to the present disclosure; [Figure 28] 1 is a partial schematic longitudinal cross-sectional view with partial cutaway of an alternative electrode configuration according to the present disclosure; [Figure 29] 1 is a schematic perspective view of a medical device balloon catheter according to the present disclosure; [Figure 30] FIG. 29 is an enlarged detail view of a portion of the distal portion of the catheter. [Figure 31] 1 is a partial schematic longitudinal cross-sectional view of the distal end of a medical device balloon catheter according to the present disclosure. [Figure 32] FIG. 32 is a partial schematic cross-sectional view CS9 of the medical device balloon catheter of FIG. 31. [Figure 33] 1 is a partial schematic longitudinal cross-sectional view of the distal end of a medical device balloon catheter according to the present disclosure. [Figure 34] FIG. 34 is a partial schematic cross-sectional view CS10 of the medical device balloon catheter of FIG. 33. [Figure 35] 1 is a partial schematic longitudinal cross-sectional view of the distal end of a medical device balloon catheter according to the present disclosure. [Figure 36] FIG. 36 is a partial schematic cross-sectional view CS11 of the medical device balloon catheter of FIG. 35. [Figure 37] 1 is a schematic perspective view of a medical device catheter according to the present disclosure; [Figure 38] 1 is a partial schematic longitudinal cross-sectional view of a distal end of a medical device catheter according to the present disclosure. [Figure 39] FIG. 39 is a partial schematic cross-sectional view CS12 of the medical device catheter of FIG. 38. [Figure 40] 1 is a schematic perspective view of a medical device catheter according to the present disclosure; [Figure 41] FIG. 41 is an enlarged detail view of FIG. 40 showing a portion of the distal portion of the catheter and the internal features and elements of the distal portion of the adapter. [Figure 42] 1 is a partial schematic longitudinal cross-sectional view of a distal end of a medical device catheter according to the present disclosure. [Figure 43a] FIG. 43 is a partial schematic cross-sectional view CS13 of the medical device catheter of FIG. 42. [Figure 43b] FIG. 43 is a partial schematic cross-sectional view CS13 of the medical device catheter of FIG. 42. [Figure 44] 1 is a partial schematic longitudinal top view of the distal end of a medical device catheter according to the present disclosure, showing internal features and elements of the distal portion of the medical device catheter; [Figure 45] 1 is a partial schematic longitudinal top view of the distal end of a medical device catheter according to the present disclosure, showing internal features and elements of the distal portion of the medical device catheter; [Figure 46] 1 is a partial schematic longitudinal cross-sectional view of a cavitation bubble chamber and a proximal portion of a guidewire lumen of a medical device catheter according to the present disclosure. [Figure 47] 1 is a partial schematic longitudinal top view of a medical device catheter according to the present disclosure, showing the internal features and elements of the cavitation bubble chamber and the proximal portion of the guidewire lumen of the medical device catheter; [Figure 48] 1 is a partial schematic longitudinal cross-sectional view of a cavitation bubble chamber and a proximal portion of a guidewire lumen of a medical device catheter according to the present disclosure. [Figure 49] FIG. 49 is a partial schematic cross-sectional view CS14 of the medical device catheter of FIG. 48. [Figure 50] 1 is a partial schematic longitudinal cross-sectional view of a cavitation bubble chamber and a proximal portion of a guidewire lumen of a medical device catheter according to the present disclosure. [Figure 51a]1 is a partial schematic longitudinal cross-sectional view of a cavitation bubble chamber and a proximal portion of a guidewire lumen of a medical device catheter according to the present disclosure. [Figure 51b] 1 is a partial schematic longitudinal side view of a cavitation bubble chamber and a proximal portion of a guidewire lumen of a medical device catheter according to the present disclosure, showing internal features and elements of the medical device catheter; FIG. [Figure 52] 1 is a partial schematic longitudinal cross-sectional view of a medical device catheter according to the present disclosure; [Figure 53] 1 is a partial schematic longitudinal cross-sectional view of a tube forming a portion of a cavitation bubble chamber of a medical device catheter according to the present disclosure. FIG. [Figure 54] 1 is a partial schematic longitudinal cross-sectional view of a tube forming a first cavitation solution lumen of a medical device catheter according to the present disclosure. FIG. [Figure 55] FIG. 1 is an enlarged detail view of a distal portion of a medical device catheter. [Figure 56] FIG. 56 is a partial schematic cross-sectional view of the medical device catheter of FIG. 55. [Figure 57] FIG. 1 is an enlarged detail view of a distal portion of a medical device catheter. [Figure 58] FIG. 58 is a partial schematic cross-sectional view of the medical device catheter illustrated in FIG. 57. [Figure 59] FIG. 58 is another partial schematic cross-sectional view of the medical device catheter illustrated in FIG. 57. [Figure 60] FIG. 58 is another partial schematic cross-sectional view of the medical device catheter illustrated in FIG. 57. [Figure 61] FIG. 61 is an enlarged detail view of an alternative embodiment of the medical device catheter illustrated in FIGS. 57-60. [Figure 62] FIG. 62 is a partial schematic cross-sectional view of the medical device catheter illustrated in FIG. 61. [Figure 63] 62 is another partial schematic cross-sectional view of the medical device catheter illustrated in FIG. 61. [Figure 64] 1 illustrates an example of a cavitation solution fluid management assembly suitable for use with a medical device catheter, according to one aspect of the present disclosure. [Figure 65] 1 illustrates an example of a cavitation solution fluid management assembly suitable for use with a medical device catheter, according to one aspect of the present disclosure. [Figure 66] 1 illustrates an example of a cavitation solution fluid management assembly suitable for use with a medical device catheter, according to one aspect of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0017] According to the present disclosure, in one aspect, an adapter can be configured with a proximal portion that interfaces with a medical device or parent module and a distal portion that modifies, enhances, or expands the configuration or intended use of the medical device. As an example, the medical device can be a catheter. An adapter or adapter module can also be considered a medical device and an accessory to the parent module medical device that enhances performance or functionality. In another aspect, an attachment mechanism on the adapter can secure the adapter to the distal end of the medical device catheter during use. The distal portion of the adapter can extend distally from the distal end of the catheter and be designed with features that extend, enhance, or modify the configuration or intended use of the medical device catheter, such as lithotripsy functionality, as further described herein.

[0018] The proximal portion of the adapter may be designed to mate with the lumen of the medical device, such as via an interference fit, so that the adapter remains securely attached during subsequent use. The proximal portion may additionally be designed for easy insertion into the lumen of the medical device. The proximal portion of the adapter may include an attachment mechanism, described more fully below, that provides fixation between the adapter and the medical device. The adapter and medical device comprise two modules of a modular medical device catheter system. The attachment mechanism allows the adapter module and the medical device module, also referred to as the parent module, to be combined as needed by a physician or physician staff in the operating room during a medical procedure to create a modular medical device catheter system. Various combinations of adapter modules or adapters with parent modules or parents allow for the flexibility of creating multiple variations of medical device catheters depending on the dynamic needs and challenges of each patient and procedure. A modular medical device catheter system according to the present disclosure provides physicians with the advantage of flexibility to build the medical device catheter of their choice, combining structural, therapeutic, and diagnostic elements at the distal end for specific procedural needs. It also provides hospitals with inventory advantages, ie, more medical device catheter variants from fewer inventory items or modules.

[0019] A medical device or parent module typically has a proximal end that remains outside the patient's body and a distal end that enters the patient's body. Examples of parent modules include, but are not limited to, balloon catheters, stent delivery system catheters, transcatheter exchange valves and related delivery catheters, stent graft delivery catheters, dissection repair catheters, atherectomy catheters, ablation catheters, aspiration catheters, and thrombectomy catheters.

[0020] An example of a suitable modular catheter system for use with the present disclosure is described in U.S. Patent No. 11,660,439 B2, issued May 30, 2023, to the present inventor, the entire contents of which are hereby incorporated by reference herein.

[0021] If an adapter module of a modular medical device catheter system includes a lumen, additional adapter modules can be added using this lumen to add further features, creating an enhanced modular medical device catheter, such as a parent + multiple adapters. The modular approach allows a parent and adapter combination to become a parent in a new parent and adapter combination.

[0022] The adapter may also include conductors for transmitting electrical signals from outside the patient's body to the distal end of the parent device. One application of this could be an adapter with a distal portion containing electrodes that are energized or activated in a manner similar to an electrophysiology catheter. The conductors in electrophysiology catheters are sometimes fine-scale copper magnet wire, e.g., 35 gauge, or other polymer-coated wire conductors, and similar conductors can be used in electrophysiology adapters. The conductors can be housed inside a central tube and electrically connect the distal portion of the adapter to the outside of the patient. A tube, wire, or mandrel can extend proximally to the proximal end of the target catheter or device.

[0023] In another aspect of the present disclosure, medical device catheters are provided that have improved functionality, such as through the incorporation of lithotripsy elements and functions, as further described herein. The catheters may be utilized either as part of a modular catheter system, as described with reference to Figures 1-28, for example, or as a single catheter design, as described with reference to Figures 29-66, among other related disclosures. In some embodiments, the single catheter may be a balloon catheter incorporating lithotripsy elements and functions.

[0024] In another aspect, a medical device catheter may include a first tube including a first cavitation solution lumen having a distal opening, a second tube containing the first tube and including a cavitation bubble chamber, a second cavitation solution lumen in fluid communication with the first cavitation solution lumen through the distal opening, and a distal plug at the distal end of the cavitation bubble chamber to create a distal boundary of the cavitation bubble chamber.

[0025] In another aspect, a proximal rapid-exchange guidewire exit port can be positioned distal to the distal boundary of the cavitation bubble chamber and in communication with the guidewire lumen.

[0026] In another aspect, the first energized electrode can extend through the first tube and first cavitation solution lumen and the cavitation bubble chamber, and beyond the distal boundary of the cavitation bubble chamber into the distal plug.

[0027] In another embodiment, a portion of the second tube can overlap a portion of the guidewire lumen.

[0028] In another embodiment, the distal end of the second tube may include a distal edge that extends beyond the proximal end of the second tube, and the distal edge may overlap a portion of the guidewire lumen.

[0029] In another embodiment, the first powered electrode can overlap a portion of the guidewire lumen.

[0030] In another embodiment, the distal opening of the first cavitation solution lumen can be proximal to the distal boundary of the cavitation bubble chamber.

[0031] In another embodiment, at least a portion of the second cavitation solution lumen can be disposed around the outside of the first tube.

[0032] In another aspect, at least a portion of the second tube can form a cavitation bubble chamber and at least a portion of the second cavitation solution lumen.

[0033] In another embodiment, the distal end of the first tube may include a distal edge that extends beyond the proximal end of the tube.

[0034] In another embodiment, the first tube can be deflected off-axis relative to the second tube.

[0035] In another embodiment, the first powered electrode can be biased off-axis relative to the first tube or the second tube.

[0036] In another embodiment, a portion of the second tube can be disposed between a portion of the first powered electrode and a portion of the guidewire lumen.

[0037] In another embodiment, a portion of the first powered electrode can be disposed between a portion of the second tube and a portion of the guidewire lumen.

[0038] In another embodiment, the second powered electrode can be disposed on the outside of the first tube.

[0039] In another aspect, the at least one intermediate electrode may be disposed outside the first tube to create a first electrode gap between the at least one intermediate electrode and the first powered electrode and a second electrode gap between the at least one intermediate electrode and the second powered electrode.

[0040] In another embodiment, at least one intermediate electrode comprises a semicircular cylinder.

[0041] In another embodiment, the at least one intermediate electrode can be coaxial with the first cavitation solution lumen.

[0042] In another embodiment, the first powered electrode does not include an insulating coating in the region of the cavitation bubble chamber.

[0043] In another embodiment, the polymer jacket may form at least a portion of the second tube and the cavitation bubble chamber.

[0044] In another aspect, the inflatable balloon can be positioned proximal to the cavitation bubble chamber.

[0045] In another embodiment, a portion of the guidewire lumen may comprise a third tube.

[0046] In another embodiment, the second tube may comprise an elongate element of an IVL adapter for use with a modular medical device catheter system, including, for example, the adapter features described with reference to Figures 1-28, including, but not limited to, elongate element 462, further described below with reference to the Figures.

[0047] In another aspect, a medical device catheter may include a proximal end configured to remain outside the patient's body, a distal end configured to enter the patient's body, and a catheter shaft including a first longitudinal centerline axis.

[0048] In another aspect, the cavitation bubble chamber can be at the distal end of the medical device catheter, include a proximal portion and a distal portion, and extend along the second longitudinal centerline axis.

[0049] In another aspect, the first cavitation solution lumen can extend into the cavitation bubble chamber and have a first distal opening positioned at a distal portion of the cavitation bubble chamber.

[0050] In another embodiment, the second cavitation solution lumen can have a second distal opening positioned at a proximal portion of the cavitation bubble chamber.

[0051] In another aspect, a first cavitation solution fitting at the proximal end of the medical device catheter can be in fluid communication with the first cavitation solution lumen, and a second cavitation solution fitting at the proximal end of the medical device catheter can be in fluid communication with the second cavitation solution lumen.

[0052] In another aspect, the catheter may include a first conductor and a second conductor and at least one electrode gap therebetween, the first conductor in electrical communication with a proximal end of the electrode gap and the second conductor in electrical communication with a distal end of the electrode gap.

[0053] In another embodiment, the catheter can include a guidewire lumen that includes a third longitudinal centerline axis.

[0054] In another aspect, the first longitudinal centerline axis, the second longitudinal centerline axis, and the third longitudinal centerline axis can each be offset from one another.

[0055] In another embodiment, the electrode gap can be positioned within the cavitation bubble chamber but outside the first cavitation solution lumen.

[0056] In another embodiment, the electrode gap can be positionally biased offset from the second longitudinal centerline axis.

[0057] In another embodiment, the electrode gap can be further positionally biased toward the third longitudinal centerline axis.

[0058] In another aspect, the electrode gap can be positionally biased within the cavitation bubble chamber by a tube that forms at least a portion of the first cavitation solution lumen.

[0059] In another aspect, the electrode gap can be positionally biased within the cavitation bubble chamber by an elongated element positioned within the cavitation bubble chamber but outside of the first cavitation solution lumen.

[0060] In another aspect, the elongate element may span the area adjacent to the electrode gap.

[0061] In another aspect, the tube forms at least a portion of the first cavitation solution lumen and may further comprise a fastening element for fastening the tube and elongate element together within the cavitation bubble chamber.

[0062] In another aspect, the cavitation bubble chamber may be formed by the outer jacket of the catheter shaft and may have a non-uniform wall thickness such that the wall thickness on one side of the cavitation bubble chamber is thicker than the wall thickness on another side of the cavitation bubble chamber, and the electrode gap is positionally biased toward the side with the thicker wall thickness.

[0063] In another aspect, the cavitation bubble chamber may include an oblong cross-sectional shape.

[0064] In another aspect, the second longitudinal centerline axis can be offset from the plane formed by the first longitudinal centerline axis and the third longitudinal centerline axis.

[0065] In another embodiment, the first conductor can extend through at least a portion of the first cavitation solution lumen and exit into the cavitation bubble chamber at a first distal opening.

[0066] In another embodiment, the second conductor can extend through at least a portion of the second cavitation solution lumen.

[0067] In another embodiment, the second conductor can be external to the second cavitation solution lumen at the proximal end of the cavitation bubble chamber.

[0068] In another aspect, the medical device catheter can be configured to flow cavitation solution from a first cavitation solution fitting, through a first cavitation solution lumen, a first distal opening, a cavitation bubble chamber, a second distal opening, a second cavitation solution lumen, and a second cavitation solution fitting.

[0069] In another aspect, the medical device catheter can be configured to flow the cavitation solution through the cavitation bubble chamber at a preferred average fluid velocity that is greater than the product of the length of the cavitation bubble chamber and the electrical pulse frequency used to create the arc discharge across the electrode gap.

[0070] In another embodiment, the medical device catheter can be configured to operate at a voltage greater than about 3000 volts, or alternatively, between about 3000 volts and about 7000 volts, or preferably about 5000 volts, to create an arc discharge across the electrode gap.

[0071] In another aspect, the cross-sectional profile of the catheter in the region of the cavitation bubble chamber may have a generally triangular geometry, and the cavitation bubble chamber may occupy a larger portion of the triangular geometry than the guidewire lumen.

[0072] The electrodes referenced throughout this disclosure may be positioned or otherwise configured to create shock waves and cavitation bubbles in a cavitation solution, for example, for intravascular lithotripsy therapy. The positioning, operation, and function of the electrodes will become clear with reference to the figures and description provided further herein.

[0073] 1 is a schematic perspective view of an electrical adapter 500 according to an embodiment of the present disclosure. The electrical adapter 500 includes a distal portion 501 that includes an electrically active element 294 and a runway 474. The electrical adapter 500 includes a distal end 477 and a proximal end 478. The electrical adapter 500 includes a proximal portion 504 that incorporates an attachment mechanism 467 and an elongated body 460. The electrical adapter 500 also includes a tubular extension 471 and an electrical connector 472.

[0074] 2 is an enlarged detailed view of the proximal portion 504 of the electrical adapter 500, the distal portion 501 of the electrical adapter 500, the attachment mechanism 467, and the elongated body 460. The attachment mechanism 467 includes an elongated element or central tube 462 and an interface element 470. The elongated body 460 includes a tubular extension 471 extending from the proximal end 466 of the central tube 462. The distal portion 501 includes a distal outlet 468 for the central lumen 465 at the distal end 477 of the adapter 500.

[0075] FIG. 3 is an enlarged detailed view of the proximal end 478 of the electrical adapter 500, showing the proximal outlet 469 for the central lumen 465 at the proximal end 478 of the adapter 500, the tubular extension 471, and the electrical connector 472 including the ring electrical contact 473.

[0076] FIG. 4 is a partial schematic cross-sectional view of the electrical adapter 500 in CS1 as illustrated in FIG. 1, showing the electrical conductor 461 and the second central tube 464 creating a central lumen 465 within the lumen 463 of the elongated element 462, as well as the interface element 470 joined to the outside of the elongated element 462.

[0077] FIG. 5 is a partial schematic cross-sectional view of the electrical adapter 500 at CS2 as illustrated in FIG. 1, showing the tubular extension 471 of the elongated body 460, which provides a lumen or conduit for both the electrical conductor 461 and the second central tube 464, which creates the central lumen 465.

[0078] 1-5 illustrate an electrical adapter 500 including a distal portion 501, which may include an electrically active element 294, such as, for example, an intravascular ultrasound (IVUS) transducer, a lithotripsy electrode, a pressure sensor, an imaging sensor, a thermocouple, an ablation electrode, and other features requiring electrical signal transmission or power. The electrical adapter 500 may also include a proximal portion 504, which incorporates an attachment mechanism 467 and an elongated body 460. The elongated body 460 of the electrical adapter 500 includes electrical conductors 461 for facilitating electrical communication between, for example, an electrical connector 472 and electrodes, as described further herein. In this configuration, the conductors 461 extend proximally from the distal portion 501 of the adapter 500 through a lumen 463 of a central tube or elongated element 462, but extend outside a lumen 465 of a second central tube 464 within the central tube 462. The second central tube 464 may be used as a guidewire lumen by the physician for over the wire techniques after the electro-medical device catheter system 600 is assembled.

[0079] The second central tube 464 may also be omitted from the design, for example, if a guidewire lumen is not needed, which may be the case in a rapid-exchange style configuration of the adapter 500. If the central tube lumen 463 is not needed for a guidewire, the central tube lumen 463 may be used as an inflation lumen as well as a passageway for conductors, for example, in an alternative configuration of the distal portion 501 of the adapter 500 where the adapter 500 includes a balloon that is inflated in vivo. In either case, the second central tube 464 may extend proximally to or beyond the proximal end 219 of the medical device catheter 201 (e.g., as shown in FIGS. 6 and 7 ). It may be advantageous for the proximal end 466 of the central tube 462 to extend a sufficient distance for the attachment mechanism 467 to incorporate a compressible interface element 470 to ensure a secure connection between the adapter 500 and the medical device catheter 201. The compressible interface elements 470 are designed to compress to interface with the lumen 211 at the distal end 213 of the medical device catheter 201 to secure the electrical adapter 500 at the distal end 213 of the medical device catheter 201. These compressible interface elements 470 are also described with reference to the inventor's U.S. Pat. No. 11,660,439 B2, referenced above and incorporated by reference in its entirety.

[0080] In an alternative embodiment, the proximal end 466 of the central tube 462 can extend to a position proximal to the proximal end 219 of the medical device catheter 201. Bonding or attaching the conductors 461 to the outer surface of the second central tube 464 can be advantageous when using the adapter 500. Alternatively, heat shrink tubing, such as thin-walled polyester heat shrink tubing, can be used to hold the conductors 461 against the outer surface of the second central tube 462 in the area proximal to the proximal end 466 of the central tube 462, creating a cohesive structure. Another alternative is to flow a polymer jacket around the conductor 461 and second central tube 464 configuration in a manner similar to other catheter manufacturing techniques, such as guide catheter manufacturing. Another alternative is to incorporate a metal or polymer helix or coil around the length of the conductor 461, second central tube 464, and central tube 462 configuration to provide buckling stability to the guidewire in a manner similar to conventional 0.035 inch guidewires.

[0081] 4 is a cross-sectional view at location "CS1" of FIGS. 1 and 2, illustrating an example of a nine (9) conductor 461 configuration. The electrical conductors 461 may comprise, for example, standard round 42 AWG magnet wire. It can be appreciated that the configuration, geometry, and number of electrical conductors can be tailored to suit the requirements of the electrically active elements of the adapter 500.

[0082] 5 is a cross-sectional view at location "CS2" in FIG. 1 and illustrates elongate body 460 for adapter 500, including tubular extension 471 extending from proximal end 466 of central tube 462. Tubular extension 471 provides a conduit for both electrical conductor 461 and second central tube 464.

[0083] The electrical conductor 461 may extend proximally from any electrically active element 294 in the distal portion 501 to a position proximal to the proximal end 219 of the medical device catheter 201, and the central tube 462, the second central tube 464, or the tubular extension 471 may or may not also extend to a position proximal to the proximal end 219 of the medical device catheter 201.

[0084] In an alternative embodiment of the electrical adapter 500 , the electrically active element may be located proximally relative to the attachment mechanism 467 rather than in the distal portion 501 .

[0085] 1-5, the proximal end 478 of the adapter 500 may include an electrical connector 472 in electrical communication with the electrodes described further in this disclosure. The connector 472 may include a ring electrical contact 473 for each conductor 461 used, e.g., nine (9) ring electrical contacts 473 for each of the nine (9) electrical conductors 461. The second central tube 464 may include a distal outlet 468 for the lumen 465 at the distal end 477 of the adapter 500 and a proximal outlet 469 at the proximal end 478 of the adapter 500.

[0086] FIG. 6A is a partial schematic perspective view of a balloon catheter or parent module 201, which is a medical device catheter including a lumen 211 at a distal end 213 before an electrical adapter 500 is attached to the distal end 213 of the balloon catheter 201, with an inflatable balloon 202 shown as inflated for illustrative purposes.

[0087] 6B is a partial schematic perspective view of an electrical adapter 500 according to one embodiment of the present disclosure attached to the distal end 213 of a balloon catheter 201, with the inflatable balloon 202 depicted as inflated for illustrative purposes. As shown, the electrically active element 294 of the distal portion 501 is distal to the distal end 213 of the balloon catheter 201. The proximal end 478 of the electrical adapter 500 and the electrical connector 472 are proximal to the proximal end 219 of the balloon catheter 201. The balloon catheter 201 includes a catheter shaft 203 for connecting the inflatable balloon 202 to a coupling assembly 215.

[0088] 7 is a schematic perspective view of an assembled electrical modular catheter system 600 according to one embodiment of the present disclosure. The assembled electrical modular catheter system 600 is a combination of a medical device catheter 201 (also known as a parent module), an electrical adapter 500, and a proximal module 502. The proximal module 502 includes an electrical connector interface 503 and is attached to the proximal end 219 of the coupling assembly 215 at the proximal end of the balloon catheter 201. The inflatable balloon 202 of the balloon catheter 201 is shown as inflated for illustrative purposes.

[0089] 6A and 6B illustrate features of a medical device balloon catheter 201, including a distal end 213 and a proximal end 219. The balloon catheter 201 includes an inflatable balloon 202 positioned near the distal end 213. The inflatable balloon 202 is connected by a catheter shaft 203 to a coupling assembly 215 near the proximal end 219 of the medical device balloon catheter 201. The catheter shaft 203 is typically a long tube with one or more lumens, at least one lumen 211 having an opening near the distal end 213.

[0090] 6B also illustrates the electrical adapter 500 after it has been secured to the medical device balloon catheter 201. The electrical adapter 500 is attached to the medical device balloon catheter 201 by inserting the proximal end of the adapter 478 into the distal end 213 of the lumen 211 of the balloon catheter 201 until the attachment mechanism 467 secures the adapter 500 to the balloon catheter 201. The interface element 470 of the attachment mechanism 467 is attached or otherwise joined to the elongate element 462 and is configured to secure the electrical adapter 500 to the medical device catheter. For purposes of illustration, the balloon catheter 201 is shown with the inflatable balloon 202 in an inflated state, but will typically be in a deflated state during attachment of the adapter 500 to the balloon catheter 201. Alternatively, the electrical adapter 500 can be attached to any other suitable medical device catheter 201, such as a stent delivery system. The balloon catheter 201 may also include a coupling assembly 215 near the proximal end 219 of the medical device balloon catheter 201 that includes a port for inflating the balloon and a port for "over-the-wire" guidewire access. The lumen 211 of the balloon catheter 201 is typically useful for use with a guidewire during minimally invasive medical procedures. As mentioned above, the distal portion 501 of the electrical adapter 500 may include an electrically active element 294, for example, near the distal end 213 of the parent medical device catheter 201.

[0091] 7 illustrates the electrical adapter 500 after it has been secured to the medical device balloon catheter 201, and after the proximal module 502 has been attached to the proximal end 219 of the balloon catheter 201 and the proximal end 478 of the electrical adapter 500. The proximal module 502 may include an electrical connector interface 503 for providing an electrical connection between the ring electrical contact 473 of the electrical connector 472 and a user interface or device for the electrically active adapter 500.

[0092] 8 is a schematic perspective view of an over-the-wire (OTW) intravascular lithotripsy (IVL) adapter 505 according to an embodiment of the present disclosure. The OTW IVL adapter 505 includes a distal portion 506 including a distal outlet 468 for a central lumen 465 at a distal end 480. The OTW IVL adapter 505 also includes an attachment mechanism 467, an elongated body 482, a proximal end 479, and a proximal electrical connector 481 including a ring electrical contact 47. The OTW IVL adapter 505 also includes a proximal outlet 469 at the proximal end 478 of the OTW IVL adapter 505.

[0093] Figure 9 is an enlarged detail view showing, among other features, the distal portion 506, attachment mechanism 467, and tubular extension 471 of an over-the-wire (OTW) intravascular lithotripsy (IVL) adapter 505. The distal portion 506 has a distal end 480 and includes a runway 474, an outer tube 484, and proximal and distal jackets, or covers, 492 and 493 at the ends of the outer tube 484. The attachment mechanism 467 includes an elongated element 462 and an interface element 470. The elongated element 462 has a proximal end 466. Figure 9 also shows the elongated body 482.

[0094] FIG. 10 is an enlarged detail view showing the distal portion 506 of the over-the-wire (OTW) intravascular lithotripsy (IVL) adapter 505, similar to FIG. 9, but the outer tube 484 is not shown to illustrate the cavitation bubble chamber 491, first electrode 486, second electrode 487, intermediate electrode 485, chamber separator 490, proximal plug 488, and distal plug 489.

[0095] 11 is a partial schematic longitudinal cross-sectional view of an over-the-wire (OTW) intravascular lithotripsy (IVL) adapter 505 according to one embodiment of the present disclosure. The OTW IVL adapter 505 includes a distal portion 506, which includes a distal outlet 468 for a central lumen 465 at a distal end 480, a runway 474, an outer tube 484, and proximal and distal jackets or covers 492 and 493 at the ends of the outer tube 484. The OTW IVL adapter 505 also includes an attachment mechanism 467 and an elongated body 482. FIG. 11 also illustrates a major or longitudinal axis 498 of the adapter 505 and the cavitation bubble chamber 491.

[0096] 12 is a partial schematic cross-sectional view of the OTW IVL adapter 505 at CS3 as illustrated in FIG. 11, showing the elongated body 482 including the first electrode 486, the second electrode 487, and the second central tube 464 creating the central lumen 465 within the lumen 463 of the elongated element 462. Also shown is the interface element 470 joined to the exterior of the elongated element 462 and the runway 474.

[0097] FIG. 13 is a partial schematic cross-sectional view of the OTW IVL adapter 505 in CS4 as illustrated in FIG. 11, showing the outer tube 484, the first electrode 486, the second electrode 487, the intermediate electrode 485, the second central tube 464, the cavitation bubble chamber 491, the proximal plug 488, and the proximal jacket or cover 492.

[0098] FIG. 14 is a partial schematic cross-sectional view of the OTW IVL adapter 505 in CS5 as illustrated in FIG. 11, showing the outer tube 484, second electrode 487, intermediate electrode 485, second central tube 464, cavitation bubble chamber 491, chamber separator 490, and proximal jacket or cover 492.

[0099] 15 is an enlarged detailed view of the distal portion 506 of an OTW IVL adapter 505 as in FIG. 9 , except that the outer tube 484, proximal jacket or cover 492, and distal jacket or cover 493 are not shown in order to illustrate the cavitation bubble chamber 491, chamber separator 490, proximal plug 488, and distal plug 489. FIG. 15 also illustrates two needles 494A and B, which can be used to puncture the proximal plug 488 and distal plug 489, forming the boundaries of the cavitation bubble chamber 491 together with the outer tube 484 (not shown) and the sharp tips of needles 494At and / or 494Bt, penetrating and penetrating the cavitation bubble chamber 491.

[0100] 8-10 illustrate an example of an over-the-wire (OTW) intravascular lithotripsy (IVL) adapter 505 having a distal end 480 and a proximal end 479. The OTW IVL adapter 505 is similar to the previously described electrical adapter 500 in that it includes an elongated body 482 similar to elongated body 460 and an attachment mechanism 467. The OTW IVL adapter 505 also includes a distal portion 506 having a cavitation bubble chamber 491 within the body of the distal portion 506 for containing a cavitation solution. In one example, the cavitation bubble chamber 491 is filled with a cavitation solution during the manufacturing process, typically a solution with a conductivity of less than 20 microsiemens per centimeter (μS / cm). A workable cavitation solution may include, for example, a 0.8 M sucrose solution or deionized water. Instead of filling the cavitation bubble chamber 491 during manufacturing, in an alternative embodiment, the cavitation bubble chamber 491 can be filled with a cavitation solution during a minimally invasive or endovascular procedure, for example, tableside in an operating room, prior to inserting the adapter 505 and parent catheter 201 or combined modular system into a patient. If the cavitation bubble chamber is filled during the procedure, the cavitation solution can be, by way of non-limiting example, saline or a mixture with saline.

[0101] As shown with further reference to the features of Figures 11 and 12, the lumen 463 of the central tube 462 of the elongate body 482 can be used to fill the cavitation bubble chamber 491 with a suitable solution during the procedure.

[0102] As illustrated in FIGS. 9-11 and 13-15, cavitation bubble chamber 491 is formed by outer tube 484 located at distal portion 506. (Note that FIG. 10 illustrates distal portion 506 of adapter 505 without outer tube 484 to show the internal features and elements associated with cavitation bubble chamber 491.) Additionally, outer tube 484 is sealed by proximal plug 488 and distal plug 489. Proximal plug 488 and distal plug 489 may typically be fabricated from a polymer via a molding or extrusion process, with a secondary reflow or bonding process used to seal the proximal and distal ends of outer tube 484, thereby creating cavitation bubble chamber 491. Additionally, inside the outer tube 484 is a central chamber separator 490 to separate the chamber into two spaces where cavitation bubbles can be created between two separate sets of electrodes: between the first electrode 486 and the intermediate electrode 485, and between the second electrode 487 and the intermediate electrode 485. The chamber separator 490 can also serve to support the center of the intermediate electrode 485, while the proximal plug 488 and the distal plug 489 can also serve to support the ends of the intermediate electrode 485.

[0103] In the example illustrated in FIG. 11 and in the cross-sectional views of FIGS. 12-14, the first electrode 486, the intermediate electrode 485, and the second electrode 487 are illustrated as wires of various cross sections running parallel to one another along the major or longitudinal axis 498 of the adapter 505 and the cavitation bubble chamber 491. The second electrode 487 and the first electrode 486 may be configured as flat wires with rectangular cross sections, where the intermediate electrode 485 may be configured as a round wire with a circular cross section. Other cross-sectional shapes, such as electrode wires with triangular cross sections, may be useful. The advantage of this parallel electrode configuration is that arcing or spark generation between the electrodes and the generated shock waves can occur anywhere along the parallel lengths where the electrodes are exposed to one another (the electrodes do not have an electrically insulating coating or cover). This may allow for more cycles of arcing or spark generation because, as the electrodes wear with repeated arcing cycles, the arcing can migrate to fresh wire locations further along the length of the parallel electrode wire set. These electrodes may be suitably fabricated from copper, graphite, tungsten, stainless steel, or other suitable conductive material. If the cavitation bubble chamber 491 will be filled with a cavitation solution during the manufacturing process and will come into contact with the electrodes 487, 486, or 485, it may be advantageous to coat the conductive material with gold or other protective coating to minimize oxidation during long-term storage, such as during the product's shelf life. If a conductive wire is used as the electrodes 487 and 486, the wire may extend through the elongated body 482 to the ring electrical contacts 473 in the electrical connector 481 of the electrical adapter 505, providing electrical continuity for communication with the high-voltage pulse generator 457 (as shown with respect to FIG. 22 ). Alternatively, electrodes 487 and 486 can be electrically connected to other electrical conductors 461 within or proximal to cavitation bubble chamber 491, as shown, for example, in FIG. 8, which in turn is electrically connected to an appropriate ring electrical contact 473 within electrical connector 481 of adapter 505.

[0104] One method for filling the cavitation bubble chamber 491 with a cavitation solution is illustrated in FIG. 15. Note that FIG. 15 illustrates the distal portion 506 of the OTW IVL adapter 505 without the outer tube 484 or the proximal and distal jackets or covers 492 and 493 as shown in FIG. 10. This is done to show the internal features and elements associated with the cavitation bubble chamber 491. As shown in the figure, two needles 494A and 494B can be used to puncture the proximal and distal plugs 488 and 489 that form the boundaries of the cavitation bubble chamber 491, along with the outer tube 484 (not shown), using the sharp tips of the needles 494At and / or 494Bt to penetrate and penetrate the cavitation bubble chamber 491. A cavitation solution can then be injected through the lumen of one or both of the needles 494A, B to fill the cavitation bubble chamber 491. It may be advantageous to inject the cavitation solution through one of the lumens of needle 494A or B, while the other needle allows trapped air to escape, more completely filling cavitation bubble chamber 491. After cavitation bubble chamber 491 is filled with cavitation solution, it may be appropriate or necessary to cover the puncture site in proximal plug 488 and distal plug 489 with proximal jacket or cover 492 and distal jacket or cover 493, sealing the puncture site (as also shown in FIGS. 9 and 10 ) to ensure that the cavitation solution does not leak from cavitation bubble chamber 491. Proximal jacket 492 and distal jacket 493 may be formed from a polymer and bonded, welded, or attached to distal portion 506. Alternatively, it may be advantageous to laser weld the puncture site to seal cavitation bubble chamber 491, among other techniques as would be understood in the art.

[0105] 16 is a schematic perspective view of a rapid exchange (RX) intravascular lithotripsy (IVL) adapter 510 according to one embodiment of the present disclosure. The RX IVL adapter 510 includes a distal portion 511. The RX IVL adapter 510 includes a distal end 475 and a proximal end 476. The RX IVL adapter 510 incorporates an attachment mechanism 467 and an elongated body 495. The RX IVL adapter 510 also includes a tubular extension 471 and an electrical connector 496 including tab electrical contacts 497.

[0106] 17 is an enlarged detailed view of a rapid exchange (RX) intravascular lithotripsy (IVL) adapter 510 according to one embodiment of the present disclosure illustrated in FIG. 16 , showing the distal portion 511 of the RX IVL adapter 510, the attachment mechanism 467, the elongated body 495, the distal end 475, and the proximal end 466 of the elongated element, also known as the central tube 462. The distal portion 511 includes a rapid exchange lumen 513 having a distal end 514 and a proximal end 515, and a runway 474. The attachment mechanism 467 includes an interface element 470 and the elongated element 462.

[0107] 18 is a partial schematic perspective view of a rapid-exchange (RX) intravascular lithotripsy (IVL) adapter 510 according to one embodiment of the present disclosure attached to the distal end 213 of a balloon catheter 201, where an inflatable balloon 202 is shown as inflated for illustrative purposes, and a guidewire 516 passes through the distal end 514 and proximal end 515 of the rapid-exchange lumen 513 (illustrated in FIGS. 17 and 21 ). Also illustrated in FIG. 18 is a junction 524 between the distal portion 511 of the balloon catheter, also known as the parent module 201, and the distal end 213. The distal portion 511 of the RX IVL adapter 510 includes a cavitation bubble chamber 520 (illustrated in FIG. 21 ) having a distal end 528 and a proximal end 527.

[0108] 19 is a partial schematic longitudinal cross-sectional view of a rapid exchange (RX) intravascular lithotripsy (IVL) adapter 510 according to the embodiment of the present disclosure illustrated in FIG. 16 , showing a distal portion 511 of the RX IVL adapter 510, the distal portion 511 including a rapid exchange lumen 513 (illustrated in FIGS. 17 and 21 ) having a distal end 514 and a proximal end 515, a runway 474, a cavitation bubble chamber 520 (illustrated in FIG. 21 ) having a distal end 528 and a proximal end 527. FIG. 19 also shows a longitudinal or major axis 509 of the RX IVL adapter 510.

[0109] Figure 20 is a partial schematic cross-sectional view of the RX IVL adapter 510 in CS6 as illustrated in Figure 19, showing the lumen 463 of the elongate element 462, the first current-carrying electrode 518, the second current-carrying electrode 519, and the ground electrode 517. Also shown are the interface element 470 and the runway 474.

[0110] 21 is a partial schematic cross-sectional view of the RX IVL adapter 510 in CS7 as illustrated in FIG. 19 showing the cavitation bubble chamber 520, which is also the lumen of the cavitation bubble tube 521, the first powered electrode 518, the second powered electrode 519, the ground electrode 517, the electrode gap 522 between the electrodes, and the rapid exchange lumen 513 formed by the rapid exchange tube 512 surrounded by the polymer body 523. Also shown is the interface element 470.

[0111] 16-21 illustrate another exemplary intravascular lithotripsy (IVL) adapter 510 according to the present disclosure. The adapter 510 includes a distal portion 511, an elongated body 495 similar to 460 described above, an attachment mechanism 467, and an electrical connector 496 having tab electrical contacts 497. An electrical conductor 461 electrically connects the three (3) tab contacts 497 on the electrical connector 496 with three (3) electrodes within the cavitation bubble chamber 520: a first energized electrode 518, a second energized electrode 519, and a ground electrode 517. The rapid exchange (RX) intravascular lithotripsy (IVL) adapter 510 has a distal end 475 and a proximal end 476. The distal portion 511 of the RX IVL adapter 510 includes a rapid exchange lumen 513 (shown in FIG. 21 ) having a distal end 514 and a proximal end 515, the proximal end 515 being distal to the distal end 213 (as shown in FIG. 18 ) of the parent medical device catheter 201 after the RX IVL adapter 510 is attached to the distal end of the medical device catheter 201 by inserting the proximal end 476 of the adapter 510 into the lumen 211 at the distal end 213 of the medical device catheter 201. The distal portion 511 of the RX IVL adapter 510 includes a runway 474 (also shown with reference to FIGS. 9-11 and 17-19 ). After the RX IVL adapter 510 is attached to the parent module (balloon catheter) 201, a portion of the runway 474 fits within the lumen 211 at the distal end 213 of the parent module 201. Typically, the runway 474 is smaller than the lumen 211 at the distal end 213 of the parent module 201 and is composed of a polymer bonded or attached to the central tube 462. The purpose of the runway 474 is to provide a robust transition or junction 524 between the distal portion 511 of the RX IVL adapter 510 and the distal end 213 of the parent module (balloon catheter) 201. The runway 474 is designed to minimize twisting or buckling at the junction 524 between the distal portion 511 and the distal end 213 of the parent module 201. The design of the runway 474 can include, for example, stainless steel braid or a higher durometer polymer to help provide a stable junction 524.

[0112] The rapid-exchange lumen 513 shown in Figure 21 is designed through geometry and material selection to function as a rapid-exchange lumen 513 for a guidewire 516 (shown in Figure 18) used during a medical procedure. The rapid-exchange lumen 513 can be formed by a separate rapid-exchange tube 512 surrounded by a polymer body 523 (e.g., as shown in Figure 21). For example, a suitable rapid-exchange tube 512 can be a thin-walled polyimide tubing, approximately 0.002 inch to 0.001 inch.

[0113] As shown in FIGS. 17-21 , the distal portion 511 of the RX IVL adapter 510 also includes a cavitation bubble chamber 520, which is also the lumen of a cavitation bubble tube 521. The cavitation bubble chamber 520 can be filled with a cavitation solution similar to the cavitation bubble chamber 491 described above. As illustrated, the cavitation bubble chamber 520 has a distal end 528 and a proximal end 527. The cavitation bubble chamber 520 can also include an opening at the distal end 528 to allow any trapped air or vapor bubbles to escape, thereby facilitating filling of the cavitation bubble chamber 520 with the cavitation solution. Within the cavitation bubble chamber 520 are three (3) electrodes, including a first powered electrode 518, a second powered electrode 519, and a ground electrode 517. The three (3) electrodes 517, 518, and 519 are illustrated as round cross-section wires running parallel to one another along the longitudinal or major axis 509 of the adapter 510 and the cavitation bubble chamber 520. The proximal end 515 of the rapid exchange lumen 513 is just proximal to the proximal end 527 of the cavitation bubble chamber 520. Alternatively, the proximal end 515 of the rapid exchange lumen 513 can be located anywhere between the distal end 528 of the cavitation bubble chamber 520 and the proximal end 527 of the cavitation bubble chamber 520. It may be advantageous to construct the distal portion 511 of the RX IVL adapter 510 configured with the proximal end 515 of the rapid exchange lumen 513 distal to the distal end 528 of the cavitation bubble chamber 520. In this configuration, the rapid exchange lumen 513 does not have a portion that runs parallel or alongside the cavitation bubble chamber 520, as shown in FIG. 21 , but can be characterized as a continuous configuration, meaning that the rapid exchange lumen 513 is more along the line of the cavitation bubble chamber 520. The advantage of the continuous configuration would be a smaller profile distal portion 511, with the disadvantage or tradeoff of a potentially longer distal portion 511.

[0114] The first and second powered electrodes 518, 519 may also have an insulating coating selectively removed or selectively applied so that the sparks that generate the shock waves and cavitation plasma bubbles 526 are created across the electrode gap 522, particularly, or across controlled non-insulated edge portions or locations along the length of the cavitation bubble chamber 520.

[0115] 22 illustrates an example wiring circuit schematic suitable for use with an over-the-wire (OTW) intravascular lithotripsy (IVL) adapter 505, according to one embodiment of the present disclosure. FIG. 22 shows a high-voltage pulse generator 457 that generates sparks and shock waves that create cavitation bubbles 458 and 459 by applying a high-voltage potential difference in series between a first electrode set 551, a first electrode 486, and an intermediate electrode 485, and between a second electrode set 552, an intermediate electrode 485, and a second electrode 487.

[0116] 23 illustrates an example of a wiring circuit schematic suitable for use with a rapid exchange (RX) intravascular lithotripsy (IVL) adapter 510, according to one embodiment of the present disclosure. As shown in FIG. 23, a high-voltage pulse generator 525 creates arcs or sparks that generate shock waves in the cavitation solution at an electrode gap 522 between the parallel lengths of a first energized electrode 518 and a ground electrode 517 and a second energized electrode 519 and a ground electrode 517 within a cavitation bubble chamber 520, which in turn create cavitation bubbles 526 by applying parallel high-voltage potential differences between a first electrode set 553, i.e., between the first energized electrode 518 and the ground electrode 517, and a second electrode set 554, i.e., between the second energized electrode 519 and the ground electrode 517.

[0117] 24 illustrates a tubular electrode assembly 540 that can be incorporated into an intravascular lithotripsy adapter according to one embodiment of the present disclosure. The tubular electrode assembly 540 includes a series of tubular electrode elements 541 having proximal ends 544 and distal ends 545 arranged in an end-to-end manner, where the tubular electrode assembly 540 has a distal end 543 and a proximal end 542.

[0118] Figure 25 is a partial schematic cross-sectional view of an RX IVL adapter similar to RX IVL adapter 510. The cross-sectional view is similar to the cross-sectional view of Figure 21 showing cross-section CS7 as illustrated in Figure 19, but shows a cross-section of an RX IVL adapter with a tubular electrode assembly 540 at location CS8 of Figure 24. Figure 25 illustrates tubular electrode elements 541 assembled within cavitation bubble tubes 521 forming cavitation bubble chambers 520 and electrode gaps 546 between adjacent tubular electrode elements 541. Figure 25 illustrates, among other features, a rapid exchange lumen 513 formed by a rapid exchange tube 512 surrounded by a polymer body 523 and an interface element 470.

[0119] 24 and 25 illustrate one example of a suitable electrode configuration according to the present disclosure. In this example, series tubular electrode elements 541 are arranged end-to-end within a tubular electrode assembly 540. As shown in the example of FIG. 24, nine (9) tubular electrode elements 541 are arranged in series to form a tubular electrode assembly 540 having eight (8) electrode gaps 546. In this example, the tubular electrode elements 541 can be manufactured by laser cutting a spiral shape from tubular stock of a suitable material having the required diameter and wall thickness. The electrode gaps 546 are formed between the proximal end 544 of one tubular electrode element 541 and the distal end 545 of an adjacent tubular electrode element. As an alternative to the spiral shape of the tubular electrode elements 541, the shape can be a circumferential ring with suitable electrode gaps defined between adjacent circumferential ring electrode elements. The tubular electrode element 541 at the proximal end 542 of the tubular electrode assembly 540 is electrically connected to one side of a high-voltage pulse generator 457 (as shown in FIG. 22 ), and the other electrical side of the high-voltage pulse generator is electrically connected to the tubular electrode element 541 at the distal end 543 of the tubular electrode assembly 540. Upon application of an appropriate high-voltage pulse, sparks, shock waves, and cavitation bubbles will be created in each of the eight (8) electrode gaps 546. The tubular electrode assembly 540 can be incorporated into the distal portion of an adapter similar to the distal portion 511 of the adapter 510 described above, except that the tubular electrode assembly 540 forms the cavitation bubble chamber 520. Cross section CS8 in Figure 25 illustrates an adapter incorporating a tubular electrode assembly 540 similar to the RX IVL adapter 510 and cross section CS7 in Figure 21 above, where the cross section arrow in Figure 24 indicates the general location of cross section CS8 of the adapter 510 incorporating the tubular electrode assembly 540. An electrode pair configuration or electrode set can include pairing a tubular electrode element with a wire or other electrode element.

[0120] 26 is a partial schematic view of an intravascular lithotripsy (IVL) adapter 530 according to one embodiment of the present disclosure, showing the distal and proximal portions 531 and 529 of the IVL adapter 530, an attachment mechanism 467, and the proximal end 466 of the elongated element, also known as the central tube 462. The distal portion 531 includes an opening 539 at the distal end to facilitate filling with a cavitation solution by allowing any trapped air or vapor bubbles to escape. The proximal portion 529 includes the attachment mechanism 467, which includes the interface element 470 and the elongated element 462, three (3) electrodes, a first current-carrying electrode 518, a second current-carrying electrode 519, and a ground electrode 517, and a tubular extension 471. Three (3) electrodes, a first powered electrode 518 , a second powered electrode 519 , and a ground electrode 517 are proximal to the proximal end 466 of the elongated element, also known as the central tube 462 .

[0121] In another example, as illustrated in FIG. 26 , an electrode configuration similar to that illustrated in adapters 505 and 510 described above can be positioned proximal to attachment mechanism 467 instead of in distal portion 506 or distal portion 511. In this case, cavitation bubble tube 521 or outer tube 484 can be omitted, such that lumen 211 of balloon catheter 201 functions as cavitation bubble chambers 520 and 491. As shown in FIG. 26 , adapter 530 includes distal portion 531 and proximal portion 529. Distal portion 531 includes a rapid exchange lumen for guidewire functionality without requiring the distal lumen of the medical device catheter. As shown in FIG. 26 , electrodes 517, 518, and 519 are positioned in proximal portion 529, just proximal to attachment mechanism 467 and just distal to tubular extension 471. In this configuration, the shockwave-generating electrodes can be positioned at the inflatable balloon 202 of the angioplasty balloon catheter parent module 201 instead of at the distal portion 531 distal to the balloon of the angioplasty balloon catheter parent module. The cavitation bubble chamber region, in this case the region of the lumen 211 of the balloon catheter 201 where the electrode sets 517, 518, and 519 are located, can be filled with a cavitation solution similar to the cavitation bubble chamber 520 described above. The distal portion 531 can also include an opening 539 at its distal end to facilitate filling with the cavitation solution by allowing any trapped air or vapor bubbles to escape.

[0122] 27 is a partial schematic diagram of an intravascular lithotripsy (IVL) adapter according to one embodiment of the present disclosure, showing a cutaway view of distal portion 532A. Distal portion 532A includes cavitation bubble chamber 520 having distal end 528 and proximal end 527, runway 474, and collinear end-to-end electrodes 536 and 537 within cavitation bubble chamber 520.

[0123] FIG. 28 is a partial schematic diagram of an intravascular lithotripsy (IVL) adapter according to one embodiment of the present disclosure, showing a cutaway view of distal portion 532B. Distal portion 532B includes a cavitation bubble chamber 520 having a distal end 528 and a proximal end 527, a runway 474, and parallel end-to-end electrodes 533 and 534 within cavitation bubble chamber 520. Instead of mostly parallel wire electrodes as shown in examples of adapters 505 and 510 of the present disclosure, the electrodes of distal portions 506 and 511, respectively, can be configured in an end-to-end configuration of distal portion 532A and distal portion 532B, as shown in FIGS. 27 and 28. A parallel electrode configuration such as that shown in adapters 505 and 510 has the advantage of being easy to manufacture, but the disadvantage of there being no specific location along the length of the electrode where an arc or spark will occur, which can be problematic if shock wave energy needs to be focused or precisely located. An end-to-end configuration such as that illustrated in Figures 27 and 28 can be arranged to provide a more precise arc or spark location.

[0124] 27 and 28 are longitudinal cross-sectional views with partial cutaways of distal portions 532A and 532B to illustrate the interior of cavitation bubble chamber 520 and alternative electrode configurations. FIG. 27 illustrates a pair of collinear end-to-end electrodes 536 and 537 in cavitation bubble chamber 520. Application of a sufficiently high voltage potential difference between the pair of electrodes 536 and 537 induces an arc or spark that generates a shock wave in electrode gap 538 between the ends of electrodes 537 and 536 within the cavitation solution, creating associated cavitation bubbles. FIG. 28 illustrates a pair of parallel end-to-end electrodes 533 and 534 in cavitation bubble chamber 520. Application of a sufficiently high voltage potential difference between the pair of electrodes 533 and 534 induces an arc or spark that generates a shock wave in electrode gap 535 between the ends of electrodes 534 and 533 within the cavitation solution, creating associated cavitation bubbles.

[0125] 29 and 30 illustrate features of a medical device balloon catheter 700, including a distal end 713 and a proximal end 719. The balloon catheter 700 includes an inflatable balloon 702 positioned near the distal end 713. The inflatable balloon 702 is connected to a fitting assembly 715 near the proximal end 719 of the medical device balloon catheter 700 by a catheter shaft 703. The catheter shaft 703 is typically a long tube having one or more lumens, at least one of which is used to inflate the inflatable balloon 702. This inflation lumen is typically connected, for example, at an inflation fitting 716, to an inflation device for pressurizing the inflatable balloon 702, typically with a saline solution. The fitting assembly 715 also includes a first cavitation solution fitting 717 and a second cavitation solution fitting 718, which are connected to the first and second cavitation solution lumens or cavities, which create fluid flow paths or connections extending between the cavitation bubble chamber and the first and second cavitation solution fittings 717, 718. The fitting assembly 715 also includes an electrical connector 714, which includes at least two electrical connector pins, a first electrical connector pin 707 and a second electrical connector pin 708. The electrical connector 714 and the first and second electrical connector pins 707, 708 are adapted to electrically couple or connect a high-voltage pulse generator to an electrode pair within the cavitation bubble chamber, respectively.

[0126] The medical device balloon catheter 700 of Figures 29-36 is a balloon catheter that can be conceptualized as an integrated, single, or "one-piece" design version of the assembled modular catheter system that includes an intravascular lithotripsy (IVL) adapter attached to the medical device balloon catheter described with reference to Figures 1-28. Instead of two modules attached together to combine an inflatable balloon feature with a cavitation bubble chamber at the distal end for delivering shockwave energy, the medical device balloon catheter 700 can integrate the IVL feature and the inflatable balloon feature in a "non-modular" or single design. The distal end 713 of the medical device catheter 700 is intended to be inserted into a body cavity, such as a blood vessel, artery, vein, or duct, to deliver shockwave energy and angioplasty in the form of an inflatable and pressurized balloon 702. The proximal end 719 is intended to remain outside the patient's body and is where the user interfaces with the medical device catheter 700, such as connecting a high voltage pulse generator, pressurizing the inflatable balloon 702, and circulating the cavitation solution to the distal end 713.

[0127] 31 is a partial schematic longitudinal cross-sectional view of a medical device balloon catheter 700 according to one embodiment of the present disclosure, showing a cross-sectional view of a portion of the medical device catheter 700 including features at its distal end 713. The medical device balloon catheter 700 includes a guidewire lumen 711 formed by a guidewire tube 704, which extends coaxially through a cavitation bubble chamber 720, an intermediate electrode 725, and an inflatable balloon 702. The cavitation bubble chamber 720 is formed by a tube, a cavitation bubble chamber tube 721. The medical device balloon catheter 700 may also include a first electrode 726, a second electrode 727, and a single cavitation solution cavity 722 that extends from the cavitation bubble chamber 720 at the distal end 713 through the inflatable balloon 702 to a location outside the patient's body, for example, at a fitting assembly 715 near the proximal end 719 of the medical device balloon catheter 700. If only a single cavitation solution cavity 722 is needed, then only one of the cavitation solution fittings is needed, for example, the first cavitation solution fitting 717 as shown in FIG. 29. In this case, the single cavitation solution cavity 722 creates a fluid flow path or connection extending between the cavitation bubble chamber 725 and the first cavitation solution fitting 717. The medical device balloon catheter 700 may also include an inflatable balloon 702 that transitions to a distal balloon tail 705 that seals the distal end of the inflatable balloon 702 near its distal end 713. The distal balloon tail 705 may be composed of the same polymer as the inflatable balloon 702 and forms the outer surface of this portion of the balloon catheter 700, where a similar or compatible polymer may be tapered at the distal end 713, where the distal exit of the guidewire lumen 711 is typically located. FIG. 31 also shows an electrode gap 728 between the first electrode 726 and the intermediate electrode 725 , and an electrode gap 729 between the second electrode 727 and the intermediate electrode 725 .The medical device balloon catheter 700 may also include an opening 723, such as a hole, slit, or passageway, near the cavitation bubble chamber 720 through the distal balloon tail 705 and the cavitation bubble chamber tube 721. A suitable cavitation solution, such as saline, may be moved to create a unidirectional flow of solution from the first cavitation solution fitting 717, through the cavitation solution cavity 722, and out of the cavitation bubble chamber 725 at the opening 723. A syringe or similar device may be connected to the cavitation solution fitting 717 and the cavitation solution may be injected to achieve this unidirectional fluid movement.

[0128] FIG. 32 is a partial schematic cross-sectional view of the cavitation bubble chamber 720, or medical device balloon catheter 700 at CS9 as illustrated in FIG. 31, showing the guidewire tube 704, guidewire lumen 711, first electrode 726, second electrode 727, cavitation bubble chamber tube 721, distal balloon tail 705, and single luminal cavity, cavitation solution cavity 722.

[0129] 31 and 32 is similar to the configuration of intermediate electrode 485, first electrode 486, and second electrode 487 as shown in FIG. 22, where a spark and associated shock wave can be generated by serially applying a high voltage potential difference between first electrode 726 and intermediate electrode 725 and between intermediate electrode 725 and second electrode 727 using high voltage pulse generator 457. Electrical communication or connection between first electrode 726 and second electrode 727 and high voltage pulse generator 457 can be established by electrically coupling or connecting first electrode 726 to first electrical connector pin 707 and second electrode 727 to second electrical connector pin 708 at electrical connector 714. The electrical connector 714 may be adapted to be electrically connected to the pulse generator 457 to deliver the necessary high voltage pulses across the electrode gaps 728 and 729 .

[0130] As illustrated in FIG. 31 , the intermediate electrode 725 may include, by way of non-limiting example, a metal or conductive tube, such as a radiopaque marker band constructed of a platinum alloy, a platinum-iridium alloy, or a tungsten alloy. In this manner, the intermediate electrode 725 provides both an electrical path for the required spark or arc discharge between the electrodes as well as a visible marker under fluoroscopy. Alternatively, the intermediate electrode may be made of a non-radiopaque conductive material, such as stainless steel or copper. The cavitation solution cavity 722 provides a lumen for adding or refreshing an appropriate cavitation solution, such as phosphate-buffered saline, to the cavitation bubble chamber 720. The cavitation solution cavity 722 lumen may extend to the proximal end 719 of the medical device balloon catheter 700 to allow a user to add an appropriate cavitation solution to the cavitation bubble chamber 720, for example, using a syringe filled with the cavitation solution attached to the first cavitation solution fitting 717. An opening 723 connecting the cavitation bubble chamber 720 to the environment distal to the inflatable balloon 702, such as a hole, slit, or passageway through the cavitation bubble chamber tube 721 and distal balloon tail 705 near or at the cavitation bubble chamber 720, can be added to add an appropriate cavitation solution to the cavitation bubble chamber 720 or to refresh the cavitation solution after arcing occurs across the electrodes. The slit, hole, or passageway 723 serves as a vent, allowing trapped gases and liquids to escape so that new cavitation solution can be added to the cavitation bubble chamber 720 via the cavitation solution cavity lumen 722. This is similar to flushing the catheter 700 with saline and pre-filling the cavitation bubble chamber 725 with cavitation solution prior to a procedure to remove trapped air.

[0131] 33 is a partial schematic longitudinal cross-sectional view of a medical device balloon catheter 701 according to one embodiment of the present disclosure, showing a cross-sectional view of a portion of the medical device balloon catheter 701, including features at its distal end 713. The medical device catheter 701 is similar to the medical device catheter 700 and includes a cavitation bubble chamber 730, an intermediate electrode 725, and a guidewire lumen 711 formed by a guidewire tube 704 that extends coaxially through the inflatable balloon 702. The cavitation bubble chamber 730 is formed by a polymer body 731. The medical device catheter 701 may also include a first electrode 726, a second electrode 727, and two cavitation solution cavities or lumens 734 and 736 that extend from the cavitation bubble chamber 730 at the distal end 713 through the inflatable balloon 702 to a location outside the patient's body, for example, to a fitting assembly 715 near the proximal end 719 of the medical device balloon catheter 701. For example, first cavitation solution lumen 734 may be connected to first cavitation solution fitting 717, and second cavitation solution lumen 736 may be connected to second cavitation solution fitting 718, so that cavitation solution fluid can circulate from a syringe connected to first cavitation solution fitting 717, through first cavitation solution lumen 734, to cavitation solution lumen 730, then back through second cavitation solution lumen 736, and out second cavitation solution fitting 718. Cavitation solution lumens 734 and 736 create a fluid transfer flow path between cavitation bubble chamber 730 and proximal end 719 of medical device balloon catheter 701, allowing fluid communication or connection therebetween.

[0132] Cavitation solution cavities or lumens 734 and 736 are formed by cavitation solution tubes 735 and 737, which are also included in the medical device balloon catheter 701. The medical device balloon catheter 701 may also include an inflatable balloon 702 that transitions to a distal balloon tail 705 that seals the distal end of the inflatable balloon 702 near its distal end 713. The distal balloon tail 705 may typically be constructed of the same polymer as the inflatable balloon 702 and forms the outer surface of this portion of the balloon catheter 701, where a similar or generic polymer is typically tapered at the distal end 713, where the distal exit of the guidewire lumen 711 is located. FIG. 33 also shows an electrode gap 728 between the first electrode 726 and the intermediate electrode 725, and an electrode gap 729 between the second electrode 727 and the intermediate electrode 725.

[0133] FIG. 34 is a partial schematic cross-sectional view of the medical device balloon catheter 701 in the cavitation bubble chamber 730 or CS10 as illustrated in FIG. 33, showing the guidewire tube 704, guidewire lumen 711, first electrode 726, second electrode 727, polymer body 731, distal balloon tail 705, and cavitation solution cavities or lumens 734 and 736 formed by cavitation solution tubes 735 and 737.

[0134] The electrode configurations of the intermediate electrode 725, first electrode 726, and second electrode 727 shown in Figures 33 and 34 are the same as those shown in Figures 31 and 32. Cavitation solution cavities or lumens 734 and 736 may extend to the proximal end 719 of the medical device catheter 701 to allow a user to add an appropriate cavitation solution to the cavitation bubble chamber 730. The cavitation solution lumens 734 and 736 provide a way to add or refresh an appropriate cavitation solution, such as phosphate buffered saline, to the cavitation bubble chamber 730. An advantage of two cavitation solution lumens, such as 734 and 736, is that one of the two lumens may be used to add fresh cavitation solution, while the other lumen may allow the liquid or gaseous components of the cavitation solution to be removed from the closed fluid circuit. For example, a user can pressurize the first cavitation solution lumen 734 at the first cavitation solution fitting 717 at the proximal end 719 with a syringe filled with fresh cavitation solution and expel the cavitation solution circulated through the cavitation bubble chamber 730 via the second cavitation solution lumen 736 at the second cavitation solution fitting 718 at the proximal end 719. This would allow the cavitation solution exposed to the high-voltage electrical pulse and trapped gas formed during the spark event to exit the closed fluid circuit. The first cavitation lumen 734 and the second cavitation lumen 736 create a fluid flow path between the cavitation bubble chamber 730 and the proximal end 719 of the medical device balloon catheter 701, enabling fluid communication or connection therebetween. This set of features and embodiments eliminates the need for openings 723, such as holes, slits, or passages, at the distal end 713 near the cavitation bubble chamber 720, as described with reference to FIG. 31, to allow for the addition or removal of cavitation solution.

[0135] The distal ends of first electrode 726 and second electrode 727 terminate at or within the proximal ends of cavitation bubble chambers 720 and 730. Intermediate electrode 725, which may be a tubular metal band coaxial with guidewire tube 704, is positioned an appropriate distance from the distal ends of first electrode 726 and second electrode 727 to ensure consistent sparking across electrode gaps 728 and 729 and the generation of the required shock wave energy. This gap spacing may typically range from about 100 to about 500 micrometers.

[0136] 35 is a partial schematic longitudinal cross-sectional view of a medical device balloon catheter 740 according to an embodiment of the present disclosure, showing a cross-sectional view of a portion of the medical device balloon catheter 740, including features at the distal end 713. The medical device catheter 740 is similar to the previously described medical device catheters 700 and 701, and includes a cavitation bubble chamber 745, an intermediate electrode 725, and a guidewire lumen 711 formed by a guidewire tube 704 extending coaxially through the inflatable balloon 702. The cavitation bubble chamber 745 is formed by a tube, the cavitation bubble chamber tube 721. The medical device catheter 740 may also include a first electrode tube 741 and a second electrode tube 743. The first electrode 741 and the second electrode 743 also form two cavitation solution cavities or lumens, first cavitation solution cavity or lumen 742 and second cavitation solution cavity or lumen 744, which extend from a cavitation bubble chamber 745 at the distal end 713, through the inflatable balloon 702, to a location outside the patient's body, such as a fitting assembly 715 near the proximal end 719 of the medical device balloon catheter 740. The first cavitation solution lumen 742 may be fluidly connected to a cavitation solution fitting 717, and the second cavitation solution lumen 744 may be fluidly connected to a cavitation solution fitting 718. The cavitation solution cavities or lumens 742 and 744 are formed in part by conductive tubing of an oval cross section, which also functions as the first electrode 741 and the second electrode 743. The medical device balloon catheter 740 may also include an inflatable balloon 702 that transitions to a distal balloon tail 705 that seals the distal end of the inflatable balloon 702 near its distal end 713. The distal balloon tail 705 may typically be constructed from the same polymer as the inflatable balloon 702 and forms the outer surface of this portion of the balloon catheter 740, where a similar or generic polymer is typically tapered at the distal end 713 where the distal exit of the guidewire lumen 711 is located.FIG. 35 also shows an electrode gap 728 between the first electrode 741 and the intermediate electrode 725, and an electrode gap 729 between the second electrode 743 and the intermediate electrode 725.

[0137] Figure 36 is a partial schematic cross-sectional view of a medical device catheter 740 at the cavitation bubble chamber 745 or CS11 as illustrated in Figure 35, showing the guidewire tube 704, guidewire lumen 711, first electrode tube 741, second electrode tube 743, cavitation bubble tube 721, distal balloon tail 705, and cavitation solution cavities or lumens 742 and 744 formed by electrode tubes 741 and 743.

[0138] 35 and 36, tubes 741 and 743 may suitably comprise a conductive material such as copper or stainless steel, where tubes 741 and 743 may serve the dual function of acting as electrodes and creating cavitation solution lumens 742 and 744. This is advantageous because combining both functions into a single feature, i.e., a pair of conductive electrode tubes 741 and 743 that both fluidly and electrically connect cavitation bubble chamber 745 to proximal end 719 of medical device balloon catheter 740 outside the patient's body, eliminates the need for a separate electrode and lumen for the cavitation solution, thus allowing for a smaller profile medical device catheter 740. Cavitation solution lumens 742 and 744 create a fluid flow path between cavitation bubble chamber 745 and proximal end 719 of medical device balloon catheter 740, allowing fluid communication or connection therebetween in the same manner as cavitation solution lumens 734 and 736, see Figures 33 and 34, which illustrate medical device balloon catheter 701. Electrode tubes 741 and 743 are shown as oval in cross section rather than round, which may further reduce the profile of the medical device catheter, although round tubes may also be suitable depending on the needs of the medical device and procedure.

[0139] In another embodiment, a catheter having a one-piece design is provided without a balloon mechanism or feature, but with an IVL feature as described above. Figure 37 illustrates features of a medical device catheter 750 including a distal end 713 and a proximal end 719 with a catheter shaft 751 therebetween. The medical device catheter 750 also includes a coupling assembly 753 near the proximal end 719 of the medical device catheter 700. The catheter shaft 751 is typically a long tube including one or more lumens and one or more electrical conductors having a longitudinal centerline axis 748. The longitudinal centerline axis 748 of the catheter shaft 751 can be conceptualized as a line tracing the center of a cross-section of the catheter shaft 751 along the length of the catheter shaft 751. The fitting assembly 753 also includes a first cavitation solution fitting 717 and a second cavitation solution fitting 718, which connect the first cavitation solution lumen 742 or cavity and the second cavitation solution lumen 744 or cavity, which create a fluid flow path or connection extending between the cavitation bubble chamber 745 and the first cavitation solution fitting 717 and the second cavitation solution fitting 718. The fitting assembly 753 also includes an electrical connector 714, which includes at least two electrical connector pins, a first electrical connector pin 707 and a second electrical connector pin 708. The electrical connector 714 and the first electrical connector pin 707 and the second electrical connector pin 708, respectively, are adapted to electrically couple or connect a high-voltage pulse generator to the electrode pair 741 and 743 within the cavitation bubble chamber 745.

[0140] The medical device catheter 750 of Figures 37-39 is a catheter that can be conceptualized as an integrated, single, or "one-piece" design version of an assembled modular catheter system, comprising an intravascular lithotripsy (IVL) adapter attached to the medical device catheter. Instead of two modules being attached together to combine catheter features with a cavitation bubble chamber at the distal end to deliver shockwave energy, the medical device catheter 750 may integrate IVL features in a "non-modular" or one-piece design. The distal end 713 of the medical device catheter 750 is intended to be inserted into a body cavity, such as a blood vessel, artery, vein, or duct, to deliver shockwave energy. The proximal end 719 is intended to remain outside the patient's body and is where the user interfaces with the medical device catheter 750, such as connecting a high-voltage pulse generator and circulating cavitation solution to the distal end 713.

[0141] 38 is a partial schematic longitudinal cross-sectional view of a medical device catheter 750 according to one embodiment of the present disclosure, showing a cross-sectional view of a portion of the medical device catheter 750, including features at the distal end 713. The medical device catheter 750 is similar to the previously described medical device catheter 740, including a guidewire lumen 711 formed by a guidewire tube 704 that extends coaxially through a cavitation bubble chamber 745 and an intermediate electrode 725, but excluding the inflatable balloon 702 feature. The catheter shaft 751 includes lumens and conductors connecting the distal end 713 and the cavitation bubble chamber 745 to the proximal end 719 therebetween. The cavitation bubble chamber 745 is formed by a tube, the cavitation bubble chamber tube 721. The medical device catheter 750 may also include a first electrode tube 741 and a second electrode tube 743. The first electrode 741 and the second electrode 743 also form two cavitation solution cavities or lumens, first cavitation solution cavity or lumen 742 and second cavitation solution cavity or lumen 744, which extend from a cavitation bubble chamber 745 at the distal end 713 to a location outside the patient's body, for example, at a fitting assembly 715 near the proximal end 719 of the medical device catheter 740. The first cavitation solution lumen 742 may be fluidly connected to a cavitation solution fitting 717, and the second cavitation solution lumen 744 may be connected to a cavitation solution fitting 718. The cavitation solution cavities or lumens 742 and 744 are formed in part by conductive tubes of oval cross-section that also function as the first electrode 741 and the second electrode 743. The catheter shaft 751 may typically be constructed of a polymer covering 755 that forms the exterior surface of this portion of the catheter 750, where the same or a compatible polymer is typically tapered at the distal end 713 where the distal exit of the guidewire lumen 711 is located. Figure 38 also shows the electrode gap 728 between the first electrode 741 and the intermediate electrode 725, and the electrode gap 729 between the second electrode 743 and the intermediate electrode 725.

[0142] Figure 39 is a partial schematic cross-sectional view of a medical device catheter 750 at a cavitation bubble chamber 745 or CS12 as illustrated in Figure 38, showing the guidewire tube 704, guidewire lumen 711, first electrode tube 741, second electrode tube 743, cavitation bubble tube 721, polymer cover 755, and cavitation solution cavities or lumens 742 and 744 formed by electrode tubes 741 and 743.

[0143] 38 and 39, tubes 741 and 743 may suitably comprise a conductive material such as copper or stainless steel, where tubes 741 and 743 may serve the dual function of acting as electrodes and creating cavitation solution lumens 742 and 744. This is advantageous because combining both functions into a single feature, i.e., a pair of conductive electrode tubes 741 and 743 that fluidly and electrically connect cavitation bubble chamber 745 to proximal end 719 of medical device catheter 750 outside the patient's body, eliminates the need for a separate electrode and lumen for the cavitation solution, thus allowing for a smaller profile medical device catheter 750. Cavitation liquid lumens 742 and 744 create a fluid flow path between cavitation bubble chamber 745 and proximal end 719 of medical device catheter 750, allowing fluid communication or connection therebetween, in the same manner as cavitation liquid lumens 734 and 736 function with reference to Figures 33 and 34 illustrating medical device balloon catheter 701. Electrode tubes 741 and 743 are shown as oval in cross section rather than round to further reduce the profile of the medical device catheter, although round tubes may also be suitable depending on the needs of the medical device and procedure.

[0144] In another aspect of the present disclosure, a medical device catheter having a unitary design is provided without the balloon mechanism or features, but with the IVL features as described above. FIG. 40 illustrates the features of a medical device catheter 760 including a distal end 713 and a proximal end 719 with a catheter shaft 761 therebetween. The medical device catheter 760 also includes a proximal coupling assembly 753 near the proximal end 719 of the medical device catheter 760. The catheter shaft 761 is typically a long tube including one or more lumens and one or more electrical conductors having a longitudinal centerline axis 748. The longitudinal centerline axis 748 of the catheter shaft 761, like the catheter shaft 751, can be conceptualized as a line tracing a central cross-section of the catheter shaft 761 along its length. Fitting assembly 753 also includes a first cavitation solution fitting 717 and a second cavitation solution fitting 718, which are connected to a first cavitation solution lumen or cavity 763 and a second cavitation solution lumen or cavity 767, which create a fluid flow path or connection extending between cavitation bubble chamber 765 and first cavitation solution fitting 717 and second cavitation solution fitting 718, as described in further detail below, for example, with reference to Figures 41-43. Fitting assembly 753 also includes an electrical connector 714 that includes at least two electrical connector pins, i.e., a first electrical connector pin 707 and a second electrical connector pin 708. The electrical connector 714 and the first and second electrical connector pins 707, 708 are each adapted to electrically couple or connect a high voltage pulse generator to an electrode pair within a cavitation bubble chamber, for example, as further described below with reference to Figures 41-43. The catheter shaft 761 includes an outer tube 766 that forms at least a portion of a cavitation bubble chamber 765 and at least a portion of a second cavitation solution lumen or cavity 767 to create a fluid flow path extending between the cavitation bubble chamber 765 and the second cavitation solution fitting 718.In the region of the cavitation bubble chamber 765, the cavity or lumen forming the second cavitation solution lumen or cavity 767 is the same as the cavitation bubble chamber 765. The catheter shaft 761 also includes a tapered transition 759 to a smaller diameter at the distal end 713 to facilitate the use of a guidewire via the guidewire lumen 757.

[0145] 41 is an enlarged detailed view of the distal portion of a medical device catheter 760 and catheter shaft 761, illustrating the distal end 713 with the outer tube 766 and tapered transition 759 hidden as dotted lines so that the internal features of the distal end 713 of the catheter shaft 761 can be illustrated. The medical device catheter 760 and catheter shaft 761 include a guidewire tube 756 having a distal end 758 and a lumen 757 sized to accommodate a guidewire for use during an interventional procedure. The medical device catheter 760 and catheter shaft 761 also include a first cavitation solution tube 764 having a distal end 778 and forming a first cavitation solution lumen or cavity 763. The catheter shaft 761 also includes a series of electrodes for the purpose of creating a series of shock waves that generate sparks, arcs, or plasma channels across an electrode gap formed therein. 41 illustrates a second conducting electrode 769 that includes an insulating covering or coating 782 such that an exposed or uninsulated edge portion 783 is at the distal end of the electrode 769. Similarly, a fourth intermediate electrode 772 is illustrated that includes an insulating covering or coating 790 such that a proximal end 792 and a distal end 791 are exposed or uninsulated. A third intermediate electrode 771 is illustrated that includes an insulating covering or coating 787 such that a proximal end 789 and a distal end 788 are exposed or uninsulated. A second intermediate electrode 762 is illustrated that is positioned with a portion distal to the distal end 778 of the lumen 763 of the first cavitation solution tube 764. As illustrated, the positioning of the second intermediate electrode 762 is such that an insulating covering is not required. 41 illustrates a third electrode gap 775 formed between the second intermediate electrode 762 and the distal un-insulated end 788 of the third intermediate electrode 771, a fourth electrode gap 776 formed between the proximal un-insulated end 789 of the third intermediate electrode 771 and the distal un-insulated end 791 of the fourth intermediate electrode 772, and a fifth electrode gap 777 formed between the proximal un-insulated end 792 of the fourth intermediate electrode 772 and the distal un-insulated end 783 of the second powered electrode 769. The first electrode gap 773 and the second electrode gap 774 are shown and described with respect to FIG. 44 below.

[0146] 42 is a partial schematic longitudinal cross-sectional view of a medical device catheter 760 according to one embodiment of the present disclosure, showing a cross-sectional view of the medical device catheter 760 and a portion of the catheter shaft 761, including features at the distal end 713 and the second intermediate electrode 762. The catheter shaft 761 includes a guidewire lumen 757 formed by a guidewire tube 756 and a cavity 754 within a tapered transition 759 to a smaller diameter at the distal end 713, where the cavity 754 is distal to the distal end 758 of the guidewire tube 756. The guidewire tube 756 extends through a cavitation bubble chamber 765 and at least a portion of a second cavitation solution lumen or cavity 767. The cavitation bubble chamber 765 and the second cavitation solution lumen or cavity 767 are formed by an outer tube 766. Within outer tube 766 and cavitation bubble chamber 765 is a distal end 778 of a first cavitation solution lumen or cavity 763 formed in part by first cavitation solution tube 764 .

[0147] Figure 43a is a partial schematic cross-sectional view of a portion of the cavitation bubble chamber 765 or medical device catheter 760 through CS13 as illustrated in Figure 42, showing the guidewire tube 756, the guidewire lumen 757, the uninsulated distal end 788 of the third intermediate electrode 771 (shown in Figure 41), the second intermediate electrode 762, the outer tube 766, the cavitation bubble chamber 765, the second cavitation solution lumen or cavity 767, and the first cavitation solution lumen or cavity 763 formed by the first cavitation solution tube 764.

[0148] Figure 43b is a partial schematic cross-sectional view of medical device catheter 760 through a portion of cavitation bubble chamber 765 or CS13 as illustrated in Figure 42, showing guidewire lumen 757, uninsulated distal end 788 of third intermediate electrode 771 (shown in Figure 41), second intermediate electrode 762, outer tube 766, cavitation bubble chamber 765, second cavitation solution lumen or cavity 767, and first cavitation solution lumen or cavity 763 formed by first cavitation solution tube 764. In this illustrative view, outer tube 766 is a dual lumen extrusion, one lumen forming guidewire lumen 757 and the other lumen forming cavitation bubble chamber 765 and second cavitation solution lumen or cavity 767.

[0149] FIG. 44 is a partial schematic longitudinal top view of the distal end 713 of the medical device catheter 760 and catheter shaft 761 shown with reference to FIGS. 40-43 , with the outer tube 766 and tapered transition section 759 hidden as dotted lines to further illustrate the internal features and electrode configuration of the distal end 713 of the catheter shaft 761. For reference, FIG. 44 can be conceptualized as a top view projection, with FIG. 42 being a side cross-sectional view projection. With reference to FIG. 44 , in addition to the shared features described with reference to the previous FIGS. 40-43 , the medical device catheter 760 and catheter shaft 761 include a guidewire tube 756 having a distal end 758 and a lumen 757 sized to accommodate a guidewire for use during an interventional procedure. The medical device catheter 760 and catheter shaft 761 also include a first cavitation solution tube 764 having a distal end 778 and forming a first cavitation solution lumen or cavity 763. The catheter shaft 761 also includes a series of electrodes for the purpose of creating a series of shock waves that generate a spark, arc, or plasma channel across an electrode gap formed therein. FIG. 44 illustrates a first current-carrying electrode 768, which includes an insulated covering or coating 780 such that an exposed or uninsulated edge portion 781 is present at the distal end of the electrode 768. Similarly, a first intermediate electrode 770 is illustrated, which includes an insulated covering or coating 784 such that a proximal end 786 and a distal end 785 are exposed or uninsulated. A second intermediate electrode 762 is illustrated, which is positioned with a distal portion 793 distal to the distal end 778 of the lumen 763 of the first cavitation solution tube 764 (see FIGS. 41-43 ) and distal to the distal boundary 752 of the cavitation bubble chamber 765. As illustrated, the second intermediate electrode 762 has an uninsulated proximal end 779 and is positioned such that an insulated covering is not required. The third intermediate electrode 771 is illustrated and includes an insulating covering or coating 787 such that the proximal end 789 and distal end 788 are exposed or uninsulated.A fourth intermediate electrode 772 is illustrated and includes an insulating covering or coating 790 such that a proximal end 792 and a distal end 791 are exposed or uninsulated. A second current-carrying electrode 769 includes an insulating covering or coating 782 such that an exposed or uninsulated edge portion 783 is at the distal end of the electrode 769.

[0150] FIG. 44 illustrates a first electrode gap 773 formed between the distal end of the first powered electrode 768 and the proximal un-insulated end 786 of the first intermediate electrode 770, a second electrode gap 774 formed between the distal un-insulated end 785 of the first intermediate electrode 770 and the proximal un-insulated end 779 of the second intermediate electrode 762, a third electrode gap 775 formed between the second intermediate electrode 762 and the distal un-insulated end 788 of the third intermediate electrode 771, a fourth electrode gap 776 formed between the proximal un-insulated end 789 of the third intermediate electrode 771 and the distal un-insulated end 791 of the fourth intermediate electrode 772, and a fifth electrode gap 777 formed between the proximal un-insulated end 792 of the fourth intermediate electrode 772 and the distal un-insulated end 783 of the second powered electrode 769.

[0151] The medical device catheter 760 of FIGS. 40-44 is a catheter that can be conceptualized as an integrated, single, or "one-piece" design version of an assembled modular catheter system, including an intravascular lithotripsy (IVL) adapter attached to the medical device catheter. Instead of two modules attached together to combine catheter features with a cavitation bubble chamber at the distal end to deliver shockwave energy, the medical device catheter 760 may integrate IVL features in a "non-modular" or one-piece design. The distal end 713 of the medical device catheter 760 is intended to be inserted into a body cavity, such as a blood vessel, artery, vein, or duct, to deliver shockwave energy. The proximal end 719 is intended to remain outside the patient's body and is where the user interfaces with the medical device catheter 760, such as connecting a high-voltage pulse generator and circulating cavitation solution to the distal end 713.

[0152] 40-44, the cavitation bubble chamber 765 is formed by the medical device catheter 760 and an outer tube 766 at the distal end 713 of the catheter shaft 761. In one embodiment, the cavitation bubble chamber 765 may contain therein two (2) powered electrodes, i.e., a first powered electrode 768 (shown with respect to FIG. 44) and a second powered electrode 769, four (4) intermediate electrodes, including a first intermediate electrode 770, a second intermediate electrode 762, a third intermediate electrode 771, and a fourth intermediate electrode 772, and a first cavitation solution tube 764, for example, forming a first cavitation solution lumen 763. Electrodes may be positioned along the length of the cavitation bubble chamber 765 to create five (5) electrode gaps, such as a first electrode gap 773, a second electrode gap 774, a third electrode gap 775, a fourth electrode gap 776, and a fifth electrode gap 777. In this example, a second cavitation solution lumen or cavity 767 is formed by the external tubing 766 so that a cavitation solution, such as saline solution, can circulate from the first cavitation solution fitting 717, through the first cavitation solution lumen 763, through the cavitation bubble chamber 765 and second cavitation solution lumen 767, and out via the second cavitation solution fitting 718. In this manner, the cavitation solution can circulate through the cavitation bubble chamber 765 on a continuous or semi-continuous basis during the intravascular lithotripsy process. In an alternative example, the guidewire tube 756 may exit the catheter shaft 761 at a location between the distal end 713 and the proximal coupling assembly 753, which may be useful in a rapid-exchange (RX) catheter version. An example of this type of rapid-exchange (RX) is illustrated in the rapid-exchange (RX) intravascular lithotripsy (IVL) adapter 510, as shown with reference to Figures 17-20.In this rapid exchange (RX) example, the guidewire 516 exits at a position 515 proximal to the proximal end 527 of the cavitation bubble chamber so that the cavitation solution can be returned through the lumen 463 of the central tube 462, where the lumen 463 is fluidly connected to the cavitation bubble chamber, as illustrated by the cavitation bubble chamber 765.

[0153] In the example illustrated in Figures 40-44, when a first energized electrode 768 is connected to the positive channel of a high-voltage pulse generator 457 (as shown and described with respect to Figure 22) and a second energized electrode 769 is connected to the negative channel of the pulse generator 457, and a sufficiently high voltage pulse is applied between the energized electrodes, then, provided that the electrode gaps are strategically staggered as illustrated so that electrical arcs or sparks occur only in the electrode gaps to complete the high-voltage pulse circuit, each electrical arc or spark across each electrode gap will create an individual shock wave and may also create associated cavitation bubbles. Continuous or semi-continuous circulation of the cavitation solution as described will facilitate sufficient removal of the generated cavitation bubbles to allow subsequent arcing and shock wave generation at the frequency required for the intravascular lithotripsy process. For the purpose of intravascular lithotripsy, a shock wave generating frequency of 1 to 10 Hz may be suitable.

[0154] In the example illustrated in Figures 40-44, the first powered electrode 768, the second powered electrode 769, the first intermediate electrode 770, the third intermediate electrode 771, and the fourth intermediate electrode 772 each include an electrically insulating covering or coating 780, 782, 784, 787, and 790 such that only selected portions of the electrodes are uninsulated or exposed, i.e., the distal end 781 of the first powered electrode 768, the proximal end 786 and the distal end 785 of the first intermediate electrode 770, the distal end 788 and the proximal end 789 of the third intermediate electrode 771, the distal end 791 and the proximal end 792 of the fourth intermediate electrode 772, and the distal end 783 of the second powered electrode 769. In this example, the second intermediate electrode 762 is the most electrically positive distal electrode in the electrode chain, positioned to allow electrical arcing only in electrode gaps 774 and 775 without the need for an optional electrically insulating cover or coating. Furthermore, the uninsulated portions of the other electrodes are strategically staggered and positioned so that electrical arcing occurs only in electrode gaps 773, 776, and 777. The electrodes can be made of a conductive material, such as graphite or a metal such as copper, stainless steel, tungsten, platinum, platinum alloys, nitinol, or other metal alloys. Examples of insulating coatings or covers include enamel, polyurethane, polyamideimide, and polyimide. An example of a suitable conductive wire for the electrodes is magnet wire, which includes a copper core with a polymer coating as an insulating cover. While the electrodes are shown as round wires, they can also be, by way of non-limiting example, flat wires or stranded, small, or fine wires bundled together to form a conductor.

[0155] In the example illustrated in Figures 40-44, the distal end 778 of the first cavitation solution lumen 763 is near or at the distal end of the cavitation bubble chamber 765, so that filling the cavitation chamber 765 with cavitation solution through the first cavitation solution lumen 763 will help facilitate removing any generated cavitation bubbles by draining the cavitation solution through the second cavitation solution lumen 767 and any lumen proximal to and fluidly connected to the second cavitation solution lumen 767.

[0156] An advantage of the electrode configuration illustrated in FIG. 44 is that the electrode gaps are distributed along the length of the cavitation bubble chamber 765 and on either side of the catheter shaft 761, producing more evenly distributed shock waves.

[0157] In an alternative configuration of the example illustrated in Figures 40-44, the uninsulated distal end 788 of the third intermediate electrode 771 can extend distally beyond the distal boundary 752 of the cavitation bubble chamber 765 in a manner similar to that of the second intermediate electrode 762.

[0158] 40-44, Figure 45 is a partial schematic longitudinal top view of a medical device catheter 760 and the distal end 713 of the catheter shaft 761, with the outer tube 766 and tapered transition section 759 hidden as dotted lines so as to illustrate the internal features of the cavitation bubble chamber 765, a portion of the second cavitation solution lumen 767, and an alternative electrode configuration. In other words, Figure 45 is similar to Figure 44, but shows an example of an alternative electrode configuration.

[0159] FIG. 45 illustrates a first energized electrode 768 including an insulating covering or coating 780 with an exposed or uninsulated portion 781 at the distal end of the electrode 768, a first intermediate electrode 794, a second intermediate electrode 795, a third intermediate electrode 796, a fourth intermediate electrode 797, and a second energized electrode 769 including an insulating covering or coating 782 with an exposed or uninsulated portion 783 at the distal end of the electrode 769. FIG. 45 illustrates a first electrode gap 798 formed between the distal end 781 of the first powered electrode 768 and the distal end of the first intermediate electrode 794, a second electrode gap 799 formed between the proximal end of the first intermediate electrode 794 and the distal end of the second intermediate electrode 795, a third electrode gap 800 formed between the proximal end of the second intermediate electrode 795 and the distal end of the third intermediate electrode 796, a fourth electrode gap 801 formed between the proximal end of the third intermediate electrode 796 and the distal end of the fourth intermediate electrode 797, and a fifth electrode gap 802 formed between the proximal end of the fourth intermediate electrode 797 and the distal uninsulated end 783 of the second powered electrode 769.

[0160] 45 can be conceptualized as a chain of electrodes and electrode gaps, where a first powered electrode 768 extends near the distal end of the cavitation bubble chamber 765, creating a first electrode gap 798 beginning at the distal end of the first intermediate electrode 794, with subsequent electrode gaps (i.e., a second electrode gap 799, a third electrode gap 800, a fourth electrode gap 801, and a fifth electrode gap 802) being created by subsequent adjacent electrodes in the electrode chain, terminating at the proximally located second powered electrode 769. As illustrated, an uninsulated distal end 781 of the first powered electrode 768 extends distally beyond the distal boundary 752 of the cavitation bubble chamber 765.

[0161] In the example electrode configuration shown in FIG. 45 , when the first powered electrode 768 is connected to the positive channel of the high-voltage pulse generator 457 (as shown and described with respect to FIG. 22 ), the second powered electrode 769 is connected to the negative channel of the pulse generator 457, and a sufficiently high voltage pulse is applied between the powered electrodes, an electrical arc or spark across each electrode gap will create individual shock waves and may also create associated cavitation bubbles. An advantage of this electrode chain configuration is that the intermediate electrodes 794, 795, 796, 797 do not require an insulating coating or cover. Another advantage of this electrode chain configuration is that the first powered electrode 768 can be formed from a conductive tube similar to the first electrode tube 741, as described with reference to FIGS. 38 and 39 , to function as both the first powered electrode 768 and the first cavitation solution lumen 763.

[0162] 45, the intermediate electrode is depicted as a round wire of a given length, but the intermediate electrode could also comprise a ring electrode similar to intermediate electrode 725 or a tubular electrode element such as tubular electrode element 541 described above. In this alternative, the intermediate ring or tubular electrode similar to 725 or 541 described above is preferably coaxial with guidewire lumen 757 and guidewire tube 756, or coaxial with first cavitational solution lumen or cavity 763 and first cavitational solution tube 764. The combination of intermediate electrodes coaxial with guidewire tube 756 and first cavitational solution tube 764 may have advantages; for example, the most distal intermediate electrode may be coaxial with guidewire tube 756 and constructed of a radiopaque material such as tungsten or platinum alloy to provide a location marker under fluoroscopy during an interventional procedure, while the more proximal intermediate electrodes may be smaller and coaxial with first cavitational solution tube 764 and constructed of a less expensive material such as stainless steel. The intermediate electrode may suitably comprise a partial ring, such as a semicircular cylinder, or a flat wire wound in a spiral to facilitate positioning the intermediate electrode during manufacture.

[0163] FIG. 46 is a partial schematic longitudinal cross-sectional view of a medical device catheter 810 according to one embodiment of the present disclosure, which includes a cavitation bubble chamber 815, a first tube 813 forming a first cavitation solution lumen 812, a distal opening 814 of the first cavitation solution lumen 812, a second cavitation solution lumen 817, a tube 816 forming at least a portion of the cavitation bubble chamber 815 and the second cavitation solution lumen 817, a first powered electrode 819, a second powered electrode 820, a first intermediate electrode 821, a second intermediate electrode 822, a first electrode gap 823, a second electrode 824, a first electrode gap 825, a second electrode 826, a first electrode gap 827, a second electrode 828, a second electrode 829, a first electrode gap 830, a second electrode 831, a second electrode 832, a first electrode gap 833, a second electrode 834, a second electrode 835, a first electrode gap 836, a second electrode 837, a first electrode gap 838, a second electrode 839, a second electrode 840, a first electrode gap 841, a second electrode 842, a first electrode gap 843, a second electrode 844, a second electrode 845, a first electrode gap 846, a second electrode 847, a second electrode 848, a first electrode gap 849, a second electrode 850, a second electrode 851, a first electrode gap 852, a second electrode 853, a second electrode 854, a first electrode gap 855, a second electrode 856, a second electrode 857, a first electrode gap 858, a second electrode 859, a second electrode 860, a first electrode gap 861, a second electrode 862, a second 40 shows a cross-sectional view of a portion of a medical device catheter 810 and catheter shaft 811 illustrating features of a second electrode gap 824, a third electrode gap 825, a distal cavitation bubble chamber plug 826, a rapid-exchange (RX) guidewire tube 827, a rapid-exchange (RX) guidewire lumen 828, a proximal exit 829 for the rapid-exchange guidewire lumen 828, a reinforcing element 830 at the proximal guidewire lumen exit 829, and a jacket 818 that covers or encases tubular exterior features such as tube 816, the rapid-exchange guidewire tube 827, and the reinforcing element 830. In this example, the features are located near the distal end (not shown) of the medical device catheter 810 and catheter shaft 811, such as the distal end 713 shown with reference to FIG. 40 for the medical device catheter 760. A distal exit (not shown) for the rapid-exchange guidewire lumen 828 is also located at the distal end (not shown) of the medical device catheter 810. Suitable examples of such RX guidewire features are also shown and described, for example, with reference to Figures 17-21, which illustrate a rapid exchange lumen 513 with a distal end 514 that serves as a distal exit for the guidewire.

[0164] Figure 47 is a partial schematic longitudinal top view of the distal end of medical device catheter 810 and catheter shaft 811, with outer jacket 818 hidden as a dotted line and tubing 816 not shown so as to further illustrate the internal features and electrode configuration of medical device catheter 810 and catheter shaft 811. For reference, Figure 47 can be conceptualized as a top view projection, with Figure 46 being a side cross-sectional view projection. Figure 47 illustrates a distal opening 814 of first tube 813, a portion of first powered electrode 819, a portion of second powered electrode 820, first intermediate electrode 821, second intermediate electrode 822, first electrode gap 823, second electrode gap 824, third electrode gap 825, a portion of distal plug 826, rapid exchange guidewire tube 827, and stiffening element 830.

[0165] 46 and 47 is a rapid-exchange medical device catheter 810 capable of delivering shock waves generated by electrohydraulic lithotripsy to a target calcified artery in a manner similar to that described with reference to the aforementioned medical device catheter 760. The medical device catheter 810 also incorporates similar features to the medical device catheter 760, including a coupling assembly 715 including a first cavitation solution coupling 717 and a first cavitation solution lumen or cavity 812 and a second cavitation solution coupling 718 connected to the second cavitation solution lumen or cavity 817 creating a fluid flow path or connection extending between a cavitation bubble chamber 815 and the first cavitation solution coupling 717 and the second cavitation solution coupling 718. The coupling assembly 715 also includes an electrical connector 714 including at least two electrical connector pins, i.e., a first electrical connector pin 707 and a second electrical connector pin 708. The electrical connector 714 and the first and second electrical connector pins 707, 708 are adapted to electrically couple or connect the high voltage pulse generator to the first and second energized electrodes 819, 820, respectively, within the cavitation bubble chamber 815. The rapid-exchange guidewire lumen 828, formed in part by the rapid-exchange guidewire tube 827, is similar to the rapid-exchange guidewire lumen 513 of the rapid-exchange (RX) intravascular lithotripsy (IVL) adapter 510 described above.

[0166] One difference between the rapid-exchange guide lumen of medical device catheter 810 and rapid-exchange (RX) intravascular lithotripsy (IVL) adapter 510 is that a portion of rapid-exchange guidewire lumen 513 overlaps and is parallel to cavitation bubble chamber 520, as illustrated in FIGS. 17-20, and rapid-exchange guidewire lumen 828 is distal to and non-overlapping with cavitation bubble chamber 815, as illustrated in FIGS. 46 and 47. Rapid-exchange guidewire lumen 828 and cavitation bubble chamber 815 can be characterized as being substantially collinear with one another, with cavitation bubble chamber 815 being proximal to tubing 827 forming rapid-exchange guidewire lumen 828. This configuration is advantageous because the smaller and lower profile of the non-overlapping configuration improves tracking through severely stenosed arterial segments during the procedure. The rapid-exchange guidewire lumen 828 has a proximal exit 829 through an opening in the sidewall of the RX guidewire tube 827, a reinforcing element 830, and a jacket 818 covering the distal end of the catheter shaft 811. The jacket 818 also covers at least a portion of the tube 816 forming the cavitation bubble chamber 815 and at least a portion of the second cavitation solution lumen 817. The opening in the sidewall of the catheter shaft 811 forming the proximal exit 829 may create a weak point that can cause kinking during use. As illustrated, the reinforcing element 830 is coaxial with a portion of the catheter shaft 811 and reinforces the catheter shaft 811 in the region of the proximal exit 829 to minimize the possibility of kinking during use. The reinforcing element 830 may be fabricated from a metal alloy, such as stainless steel or nitinol, laser cut from a tube to form an opening in the sidewall in the region of the proximal exit 829.

[0167] The tube 816 forming the cavitation bubble chamber 815 and at least a portion of the second cavitation solution lumen 817 may be manufactured with a known diameter or size and are preferably not otherwise expandable. In one embodiment, the tube 816 may be manufactured from a thermosetting plastic such as a thin-walled polyimide on the order of about 0.001 to 0.003 inches thick. In other embodiments, the tube 816 may be manufactured from common thermoplastic catheter materials such as PEBAX or nylon to create a sufficiently rigid tubular substrate necessary to form the cavitation bubble chamber 815. The tube 816 may also comprise a composite or laminate structure, including a combination of a polymer substrate with braided or coiled metallic or polymeric wire or fiber for additional reinforcement.

[0168] The jacket 818 can comprise a polymer such as PEBAX or nylon and can be fabricated to cover the distal end of the catheter shaft 811 using a thermal reflow process common in catheter manufacturing. The features of the medical device catheter 810 can be incorporated into an adapter design similar to the rapid exchange (RX) intravascular lithotripsy (IVL) adapter 510 described above by further utilizing the tube 816 forming the cavitation bubble chamber 815 and at least a portion of the second cavitation solution lumen 817 as an elongated element or central tube, such as the central tube 462 of the attachment mechanism 467 of the adapter 510.

[0169] 46 and 47 further illustrate a distal plug 826 occluding the lumen of the tube 816, forming the distal boundary 752 of the cavitation bubble chamber 815. The distal plug 826 also secures the distal end of the first energized electrode 819, which extends beyond the distal boundary 752 of the cavitation bubble chamber 815. Furthermore, in this configuration, the proximal exit 829 of the rapid-exchange guidewire lumen 828 and associated features are positioned distal to the distal boundary 752 of the cavitation bubble chamber 815, which may allow for a smaller overall profile of the medical device catheter 810, as opposed to designs that require the guidewire lumen to extend through the cavitation bubble chamber 815 and associated electrodes, as well as other IVL features. As illustrated, the first energized electrode 819 may comprise a round, elongated member, such as a wire or mandrel, and does not require an insulating coating on the portion exposed to the illustrated cavitation bubble chamber 815. A portion of first powered electrode 819 may be within and coaxial with tube 813 forming a portion of first cavitation solution lumen 812 and may extend distally from a distal opening 814 of first cavitation solution lumen 812 formed by tube 813. Tube 813 forming at least a portion of first cavitation solution lumen 812 may be constructed from an insulating material, such as polyimide or polyurethane, to electrically insulate the first powered electrode from second powered electrode 820 and first intermediate electrode 821, thereby ensuring that electrical arcing or sparking occurs only in first electrode gap 823 between first powered electrode 819 and second intermediate electrode 822. Furthermore, the electrode spacing of first intermediate electrode 821 and second powered electrode 820 is configured to allow electrical arcing or sparking to occur in electrode gaps 824 and 825 without the need for insulating electrode covers or coatings. Intermediate electrodes 821 and 822 are illustrated as rings or sections of tubing that are coaxial with the exterior surface of tubing 813 that forms at least a portion of first cavitation solution lumen 812 .The second energized electrode 820 is also illustrated as a ring or tube coaxial with and surrounding a portion of the exterior surface of the tube 813 that forms at least a portion of the first cavitation solution lumen 812, but may also be formed from a wire, a partial tube, a spring such as a coil, or a combination of features. The electrode may be constructed from a conductive material such as, by way of non-limiting example, stainless steel, copper, tungsten, platinum alloy, or nitinol.

[0170] FIG. 48 is a partial schematic longitudinal cross-sectional view of a medical device catheter 840 according to one embodiment of the present disclosure, which includes a cavitation bubble chamber 815, a first cavitation solution lumen 812, a first tube 813 forming the first cavitation solution lumen 812, a distal opening 814 of the first cavitation solution lumen 812, a second cavitation solution lumen 817, a tube 833 forming the cavitation bubble chamber 815 with a distal boundary 752 and at least a portion of the second cavitation solution lumen 817, a first powered electrode 819, a second powered electrode 820, a first intermediate electrode 821, a second intermediate electrode 822, a third intermediate electrode 823, a fourth intermediate electrode 824, a fifth intermediate electrode 825, a fifth intermediate electrode 826, a sixth intermediate electrode 827, a fifth intermediate electrode 828, a sixth intermediate electrode 829, a sixth intermediate electrode 830, a sixth intermediate electrode 831, a seventh intermediate electrode 832, a seventh intermediate electrode 833, a fifth intermediate electrode 834, a sixth intermediate electrode 835, a seventh intermediate electrode 836, a seventh intermediate electrode 837, a seventh intermediate electrode 838, a seventh intermediate electrode 839, a seventh intermediate electrode 840, a seventh intermediate electrode 841, a seventh intermediate electrode 842, a seventh intermediate electrode 843, a seventh intermediate electrode 844, a seventh intermediate electrode 845, a seventh intermediate electrode 846, a seventh intermediate electrode 847, a seventh intermediate electrode 848, a seventh intermediate electrode 849, a seventh intermediate electrode 850, a seventh intermediate electrode 851, a seventh intermediate electrode 852, a seventh intermediate electrode 853, a seventh intermediate electrode 854, a seventh intermediate electrode 8 8 shows a cross-sectional view of a portion of a medical device catheter 840 and catheter shaft 841 illustrating features of a jacket 818 covering or encasing tubular exterior features such as an inter-electrode 822, a first electrode gap 823, a second electrode gap 824, a third electrode gap 825, a distal cavitation bubble chamber plug 826, a rapid-exchange (RX) guidewire tube 827, a rapid-exchange (RX) guidewire lumen 828, a proximal exit 829 for the rapid-exchange guidewire lumen 828, and at least a portion of the tubing 833, the rapid-exchange guidewire tube 827, and first current-carrying electrode 819. The tubing 833 can be manufactured such that a top distal edge 831 extends distally relative to a bottom proximal edge 832. This feature can be manufactured by cutting the end of the tubing 833 at an angle such that the proximal edge 832 is proximal to the distal edge 831. Alternatively, tube 833 can be notched, cut, or machined to allow upper distal edge 831 to extend distally beyond edge 832. In this example, the feature may be located near the distal end (not shown) of medical device catheter 840 and catheter shaft 841, such as distal end 713 shown with reference to FIG. 40 for medical device catheter 760. A distal exit port (not shown) for rapid exchange guidewire lumen 828 is also present at the distal end (not shown) of medical device catheter 840. Suitable examples of such RX guidewire features are also shown and described with reference to FIGS. 17-21 , which illustrate, for example, rapid exchange lumen 513 with distal end 514 serving as a distal exit port for the guidewire.

[0171] Figure 49 is a partial schematic cross-sectional view of a medical device catheter 840 through a portion of the catheter shaft 841 at the location of the cavitation bubble chamber 815 or distal boundary 752 of the cavitation bubble chamber 815 forming CS14 as shown in Figure 48 and the proximal exit 829 for the rapid-exchange guidewire lumen 828, distal to the tube 833, showing the first energized electrode 819, a portion of the distal cavitation bubble chamber plug 826, and the jacket 818 (which also functions to cover or encase tubular external features such as the tube 833, the rapid-exchange guidewire tube 827, and at least a portion of the first energized electrode 819 illustrated in Figure 48).

[0172] 48 and 49 is a rapid-exchange medical device catheter 840 capable of delivering shock waves generated by electrohydraulic lithotripsy to a target calcified artery in a manner as described with reference to medical device catheter 760 above, which has similar features to medical device catheter 810, including tubing 827 forming a rapid-exchange guidewire lumen 828 distal to cavitation bubble chamber 815. However, medical device catheter 840 incorporates a rapid-exchange lumen 828 that is not substantially collinear with cavitation bubble chamber 815, or tubing 833 that forms cavitation bubble chamber 815 and at least a portion of second cavitation solution lumen 817.

[0173] Distal plug 826 also secures distal end 809 of first energized electrode 819, which extends beyond distal boundary 752 of cavitation bubble chamber 815. In this configuration, proximal exit 829 of rapid-exchange guidewire lumen 828 and associated features are positioned distal to distal boundary 752 of cavitation bubble chamber 815, which may allow for a smaller overall profile of medical device catheter 810, as opposed to designs requiring the guidewire lumen to extend through cavitation bubble chamber 815 and associated electrodes, as well as other IVL features. As illustrated, to further allow for a smaller profile, rapid-exchange lumen 828 and cavitation bubble chamber 815 are still substantially parallel but have offset axes to accommodate the overlap of first energized electrode 819 with rapid-exchange lumen 828 formed by tubing 827. By overlapping in this manner, the first powered electrode spans the portion of the catheter shaft 841 at the proximal exit 829 for the rapid-exchange guidewire lumen 828. By spanning the proximal exit 829 in this manner, the first powered electrode 819 can function as a reinforcing element in this area, which may otherwise be potentially weakened or pose a risk of kinking due to the opening of the proximal exit 829. If the first powered electrode 819 is fabricated from, for example, stainless steel or nitinol, it may function as both a conductive electrode and a reinforcing feature, although other conductors with sufficient strength characteristics may be suitable, including, but not limited to, tungsten and tungsten alloys, and nickel and nickel alloys.

[0174] 48, tube 833 can be manufactured such that top distal edge 831 extends distally relative to bottom proximal edge 832. This feature can be manufactured by cutting the end of tube 833 at an angle such that edge 832 is proximal to edge 831. Alternatively, tube 833 can be notched, cut, or machined to allow top edge 831 to extend distally beyond edge 832.

[0175] 48 and 49 further illustrate how, in this configuration, the distal cavitation bubble chamber plug 826 and jacket 818 can be manufactured to be integral into a single polymer body in the area of ​​the catheter shaft 841. This integration can be achieved via a reflow heating process in which two polymer components are fastened together in a desired location and heated until both melt and flow together into a single component or body.

[0176] Figure 49 also illustrates the first powered electrode 819 having a round cross-section, but it can have a rectangular, oblong, square, or other geometric cross-section as desired, for example, to reduce the overall profile of the catheter shaft 841. Figure 48 also illustrates how biasing or positioning the first powered electrode 819 to one side of the cavitation bubble chamber 815 allows for a reduction in the overall profile or cross-sectional size of the catheter shaft 841. The second powered electrode 820, the tube 813 forming the first cavitation solution lumen 812, and the intermediate electrodes 821 and 822 can also be biased to one side as shown in the figure to achieve a smaller overall profile of the catheter shaft 841.

[0177] FIG. 50 is a partial schematic longitudinal cross-sectional view of a medical device catheter 845 according to one embodiment of the present disclosure, which includes a cavitation bubble chamber 815 having a distal boundary 752, a first cavitation solution lumen 812, a first tube 813 forming the first cavitation solution lumen 812, a distal opening 814 of the first cavitation solution lumen 812, a second cavitation solution lumen 817, a tube 833 forming at least a portion of the cavitation bubble chamber 815 and the second cavitation solution lumen 817, a first powered electrode 819, a second powered electrode 820, a first intermediate electrode 821, a second intermediate electrode 822, a first electrode gap 833, a second powered electrode 833, a first electrode gap 833, a second electrode gap ... 8 shows a cross-sectional view of a portion of a medical device catheter 845 and catheter shaft 846 illustrating features of jacket 818 covering or encasing tubular exterior features such as 823, second electrode gap 824, third electrode gap 825, distal cavitation bubble chamber plug 826, rapid exchange (RX) guidewire tube 827, rapid exchange (RX) guidewire lumen 828 (shown occupied by guidewire 834), proximal exit 829 for rapid exchange guidewire lumen 828, and tubing 833, proximal end 835, and at least a portion of rapid exchange guidewire tube 827 having first energized electrode 819.

[0178] FIG. 50 also illustrates top edge 831 of tube 833 extending distally beyond bottom edge 832 such that edge 832 of tube 833 is proximal to edge 831 of tube 833. Also illustrated is a guidewire 834 passing through a rapid-exchange (RX) guidewire lumen 828 of rapid-exchange guidewire tube 827. These features may be located near the distal end (not shown) of medical device catheter 845 and catheter shaft 846, such as distal end 713 shown with reference to FIG. 40 for medical device catheter 760. A distal exit port (not shown) for rapid-exchange guidewire lumen 828 is also present at the distal end (not shown) of medical device catheter 845. Suitable examples of such RX guidewire features are also shown and described with reference to FIGS. 17-21 , which describe, for example, a rapid-exchange lumen 513 with distal end 514 that serves as a distal exit port for the guidewire.

[0179] 50 illustrates another suitable configuration in which both the first powered electrode 819 and the portion of the tube 833 forming the cavitation bubble chamber 815 overlap the rapid-exchange guidewire tube 827 in a portion distal to the proximal guidewire exit port 829 and the proximal end 835 of the rapid-exchange guidewire tube 827. This can be conceptualized as when, in this overlap region, the first powered electrode 819 is positioned or located between a portion of the inner surface of the tube 833 and a portion of the outer surface of the rapid-exchange guidewire tube 827. As illustrated, in this region, the tube 833 has been cut, notched, or otherwise fabricated with an edge 831 extending distally beyond the distal end 809 of the first powered electrode 819 such that the tube 833 also has a proximal edge 835 of the rapid-exchange guidewire tube 827 and an edge 832 proximal to the proximal guidewire exit port 829. Overlapping a portion of the tube 833, the first current-carrying electrode 819, and the rapid-exchange guidewire tube 827 in the region between the proximal end 835 of the rapid-exchange guidewire tube 827 and the edge 832 of the tube 833 where the proximal guidewire exit 829 is formed provides additional structural support in this region while maintaining a low transmission cross-sectional profile. As previously mentioned, further adding to the low or small profile is the cavitation bubble chamber 815 and associated electrode and IVL features positioned proximally relative to the separate guidewire lumen 828 and proximal exit 829, such that the guidewire 834 and lumens do not need to pass through those IVL features. As shown, the rapid-exchange guidewire lumen 828 is formed by the tube 827; however, it can be appreciated that, as an alternative, the lumen 828 could be formed by the jacket or polymer body 818 of the catheter shaft 851 in that portion without the need for a separate tube.

[0180] 50 further illustrates distal cavitation bubble chamber plug 826 as a distinct feature that is not necessarily integral with jacket 818, which covers or encases tubular external features such as tubing 833 and rapid-exchange guidewire tubing 827. Distal cavitation bubble chamber plug 826 seals the distal portion of tubing 833, enclosing and securing a portion of first powered electrode 819, as well as defining distal boundary 752 of cavitation bubble chamber 815 and holding it proximal to guidewire proximal exit 829, as will be described. Additionally, distal cavitation bubble chamber plug 826 biases first powered electrode 819 to an off-axis position relative to the axis of cavitation bubble chamber 815 such that at least a portion of the axis of first powered electrode 819 is not coaxial with cavitation bubble chamber 815. Similarly, first cavitation solution tube 813 and first cavitation solution lumen 813 are biased to be positioned off-axis relative to the cavitation bubble chamber 815 axis.

[0181] 50 further illustrates first intermediate electrode 821 and second intermediate electrode 822 as rings or portions of tubes that do not form a complete circle. For example, first intermediate electrode 821 and second intermediate electrode 822 can be semicircular cylinders having a cross-sectional arc of 180 degrees, or more preferably, an arc that is greater than 180 degrees but less than 360 degrees. This configuration will deflect the arc discharge toward the bottom of cavitation bubble chamber 815 as illustrated.

[0182] FIG. 51a is a partial schematic longitudinal cross-sectional view of a medical device catheter 850 according to one embodiment of the present disclosure, showing a cross-sectional view of the medical device catheter 850 and a portion of the catheter shaft 851, and FIG. 51b is a partial schematic longitudinal cross-sectional view of a medical device catheter 850 according to one embodiment of the present disclosure, showing a cross-sectional view of the medical device catheter 850 and a portion of the catheter shaft 851 with an outer polymer jacket shown as a hidden dotted line. 51a and 51b show a cavitation bubble chamber 815 having a distal boundary 752 (also partially hidden by a dotted line in FIG. 51b), a first tube 813 forming a first cavitation solution lumen 812 (not shown in FIG. 51b but illustrated in FIG. 51a), a distal opening 814 of the first cavitation solution lumen 812, a second cavitation solution lumen 817, a tube 852 forming a portion of the cavitation bubble chamber 815 and at least a portion of the second cavitation solution lumen 817, a first powered electrode 819, a second powered electrode 820, a first intermediate electrode 821, Illustrated are features of a jacket 818 (illustrated with hidden lines to show internal features) that covers or encases tubular external features such as second intermediate electrode 822, first electrode gap 823, second electrode gap 824, third electrode gap 825, distal cavitation bubble chamber plug 826, rapid exchange (RX) guidewire tube 827, rapid exchange (RX) guidewire lumen 828, proximal exit 829 for rapid exchange guidewire lumen 828, as well as tube 852, rapid exchange guidewire tube 827 having proximal end 835, and at least a portion of first current-carrying electrode 819.51a and 51b also illustrate a bottom distal edge 831 of tube 852 extending distally beyond a top proximal edge 832 such that edge 832 of tube 852 is proximal to edge 831 of tube 852, electrode gap 825, and cavitation bubble chamber 815; similarly, first tube 813 forming at least a portion of first cavitation solution lumen 812 includes a top proximal edge 805 at a distal opening 814 of first cavitation solution lumen 812 and a bottom distal edge 804 that extends distally beyond distal boundary 752 of cavitation bubble chamber 815. These features may be located near the distal end (not shown) of medical device catheter 850 and catheter shaft 851, such as distal end 713 shown with reference to FIG. 40 for medical device catheter 760. A distal exit (not shown) for the rapid-exchange guidewire lumen 828 is also at the distal end (not shown) of the medical device catheter 850. Suitable examples of such RX guidewire features are also shown and described with reference to, for example, Figures 17-21, which illustrate a rapid-exchange lumen 513 with a distal end 514 that serves as a distal exit for the guidewire.

[0183] 51a and 51b illustrate another preferred configuration in which both the first powered electrode 819 and the portion of the tube 852 forming the bottom portion of the cavitation bubble chamber 815 overlap with the rapid-exchange guidewire tube 827 at a portion distal to the proximal guidewire exit port 829 and the proximal end 835 of the rapid-exchange guidewire tube 827. This can be conceptualized as where, in this overlap region, the first powered electrode 819 is positioned adjacent to or located adjacent to a portion of the inner surface of the tube 852, and a portion of the outer surface of the rapid-exchange guidewire tube 827 is positioned adjacent to or adjacent to the outer surface of the tube 852. This can be further conceptualized as where the first powered electrode 819, the portion of the tube 852, and the portion of the rapid-exchange guidewire tube 827 form a structure in which a portion of the tube 852 is disposed between a portion of the first powered electrode 819 and a portion of the rapid-exchange guidewire tube 827. As illustrated, in this region, tube 852 is cut, notched, or otherwise fabricated at an edge 831 that extends distally beyond distal end 809 of first powered electrode 819 such that tube 852 also has an edge 832 that is proximal to third electrode gap 825. As illustrated, cavitation bubble chamber 815 is formed by tube 852 and a portion of outer jacket 818. The overlap of portion of first powered electrode 819, portion of tube 852, and rapid-exchange guidewire tube 827 in the region between proximal end 835 of rapid-exchange guidewire tube 827 provides additional structural support in this region and further enables a smaller overall profile of medical device catheter 850. An advantage of this configuration is that the guidewire does not need to bend significantly at the proximal guidewire exit 852 during use, as the proximal guidewire exit 829 and guidewire tube 827 follow a path that is generally parallel to the tube 852 and catheter shaft 851. This is in contrast to the path of the guidewire 834 illustrated in FIG. 50, which requires an "S" bend as it exits the proximal guidewire exit 829.

[0184] 51a and 51b also illustrate that the axis of the first powered electrode 819 is not coaxial with the cavitation bubble chamber 815, but rather the first powered electrode 819 is biased to have an axis, with a portion of it being deflected off-axis, or away from the axis of the cavitation bubble chamber 815, toward the side of the cavitation bubble chamber 815 closer to the rapid-exchange guidewire tube 827. The second powered electrode 820, the tube 813 forming the first cavitation solution lumen 812, and the intermediate electrodes 821 and 822 are also similarly deflected to one side as shown. As shown, the rapid-exchange guidewire lumen 828 is formed in part by the jacket 818 and the tube 827, although it can be understood that, as an alternative example, the lumen 828 could be formed by the jacket or polymer body 818 of the catheter shaft 851 in that portion without the need for a separate tube. In this example, first powered electrode 819 and a portion of tubing 852 overlap with lumen 828 in a region just distal to proximal guidewire exit port 829, strengthening the region of catheter shaft 851 just proximal to proximal guidewire exit port 829. Additionally, in this example, a portion of the outer surface of tubing 852 in the overlap region can form part of the wall of lumen 828.

[0185] 51a and 51b further illustrate a portion of the distal opening 814 of the first cavitation solution lumen 812 proximal to the distal boundary 752 of the cavitation bubble chamber 815, providing a fluid communication path between the first cavitation solution lumen 812, the cavitation bubble chamber 815, and the second cavitation solution lumen 817.

[0186] 51a and 51b further illustrate the first intermediate electrode 821 and the second intermediate electrode 822 as rings or portions of tubes that do not form a complete circle. For example, the first intermediate electrode 821 and the second intermediate electrode 822 can be semi-cylinders having a 180-degree cross-sectional arc. This configuration deflects the arc discharge toward the upper side of the cavitation bubble chamber 815 as illustrated. Furthermore, it can be appreciated that the first powered electrode 819 does not require any insulating coating in the area of ​​the cavitation bubble chamber 815 or in the first cavitation solution lumen 812 because the first cavitation solution tube 813 acts as an electrical barrier separating the first powered electrode 819 from the intermediate bodies 821, 822, and the second powered electrode 820.

[0187] 51a and 51b also illustrate that the first cavitational solution tube 813 is cut, notched, or otherwise fabricated with a distal edge 804 that extends distally beyond the distal boundary 752 of the cavitational bubble chamber 815 and a proximal edge 805 that is at the distal opening 814 of the first cavitational solution lumen 812. As illustrated, the distal edge 804 of the first cavitational solution tube 813 is secured to and oriented relative to the first powered electrode 819 via a distal plug 826. This configuration ensures the desired orientation of the intermediate electrodes 821 and 822 relative to the first powered electrode 819, which includes deflecting the spark gap 823 to occur between the top of the first powered electrode 819 as illustrated and the nearest intermediate electrode 822 where the cavitational solution volume is greater.

[0188] FIG. 52 is a partial schematic longitudinal cross-sectional view of a portion of the catheter shaft 811, showing the internal features in the section proximal to the cavitation bubble chamber. FIG. 52 illustrates a first current-carrying electrode 819, a second current-carrying electrode 820, a tube 813 forming a portion of a first cavitation solution lumen 812, a tube 816 forming a portion of a second cavitation solution lumen 817, an intermediate second current-carrying conductor 854 formed in a coil or spiral and coaxial with the tube 813 and electrically connected or coupled to the second current-carrying electrode 820, a proximal second current-carrying conductor 855 electrically connected or coupled to the intermediate second conductor 854, a proximal first cavitation solution lumen 857 forming a proximal first cavitation solution lumen 859 fluidly connected to the first cavitation solution lumen 812, and a proximal second cavitation solution lumen 856 forming a proximal second cavitation solution lumen 858 fluidly connected to the second cavitation solution lumen 817. Any jacket or outer polymer body, such as jacket 818 shown in the previous figure, is not illustrated for clarity.

[0189] FIG. 52 illustrates a transition at a location proximal to a cavitation bubble chamber, such as cavitation bubble chamber 815 in catheter shaft 811 shown and described with reference to the previous figures and embodiments, in which the effective size of first cavitation solution lumen 812 and second cavitation solution lumen 817 is increased to increase the net capacity for cavitation solution fluid flow. The effective annular space or lumen size in lumens 858 and 859 is larger than the effective annular space or lumen size in lumens 817 and 812, respectively. As illustrated, tube 856 is coaxial with and overlaps tube 816 and is bonded together through either an adhesive bonding operation or a reflowed polymer jacket over both, creating a continuous structure. Similarly, tube 857 is coaxial with and overlaps tube 813. Also illustrated is an electrically continuous configuration of the second energized electrode circuit, which includes a second energized electrode 820 beginning at the proximal end of the cavitation bubble chamber 815, transitioning to an intermediate second energized conductor 854, and then transitioning to a further proximal second energized conductor 855. The proximal end of the second energized electrode 820 may be welded, soldered, brazed, or otherwise electrically connected to the distal end of the electrical conductor 854, which may also be welded, soldered, brazed, or otherwise electrically connected to the distal end of the electrical conductor 855. The electrical conductor 854 is illustrated as a coil or helix coaxial with the tube 813. This coil configuration creates a more flexible catheter shaft 811 structure while still maintaining the necessary electrical continuity. Where space permits, the electrical conductor 854 may comprise a straight electrical conductor wire, such as a flat wire of copper or stainless steel. An alternative configuration may comprise a continuous conductive wire, for example a flat wire of copper or stainless steel, spanning the entire length required for the second current-carrying electrode 820, the intermediate electrical conductor 854, and a portion of the proximal electrical conductor 855.

[0190] FIG. 53 is a partial schematic longitudinal cross-sectional view of a tube 833 suitable for use in the medical device catheter 845 configuration shown and described with reference to, for example, FIG. 50 , forming at least a portion of a cavitation bubble chamber 815 (not shown) and a second cavitation solution lumen 817 (not shown) according to one embodiment of the present disclosure. FIG. 53 illustrates a notch or cut 838 formed or made in the distal end of the tube 833, forming a distal edge 831 at the top of the tube 833 and a proximal edge 832 at the bottom of the tube 833. FIG. 53 further illustrates that the tube 833 has an inner or interior surface 836 and an outer or exterior surface 837. It will be understood that if the tube 833 as illustrated in FIG. 53 were mirrored about its longitudinal axis, the distal edge 831 would be at the bottom and the proximal edge 832 would be at the top, and thus would be suitable for use as a tube 852 as illustrated and described with reference to, for example, FIG. 51 .

[0191] Figure 54 is a partial schematic longitudinal cross-sectional view of a tube 813 suitable for use in the medical device catheter 850 configuration shown and described with reference to Figures 51a and 51b, for example, forming a first cavitation solution lumen 812 having a distal opening 814 according to another embodiment of the present disclosure. Figure 54 illustrates a notch or cut 806 formed or made in the distal end of the tube 813 forming a distal edge 804 at the bottom of the tube 813 that extends beyond a proximal edge 805 at the top of the tube 813 around the distal opening 814.

[0192] FIG. 55 is an enlarged detailed view of the distal portion of the medical device catheter 860 and catheter shaft 861, illustrating the distal end 862 with an outer jacket 864 and tapered transition 865 shown fictitiously as dotted lines so that the internal features of the distal end 862 of the catheter shaft 861 can be illustrated. Medical device catheter 860 is similar to medical device catheter 760 and includes the same features at the first longitudinal centerline axis 748 and proximal end 719 of catheter shaft 861 as shown with reference to FIG. 40 for medical device catheter 760, including a proximal coupling assembly 753, which includes a first cavitation solution coupling 717 and a second cavitation solution coupling 718, which are connected to a first cavitation solution lumen or cavity 872 and a second cavitation solution lumen or cavity 875, which creates a fluid flow path or connection extending between cavitation bubble chamber 867 and first cavitation solution coupling 717 and second cavitation solution coupling 718, as described in further detail below. The fitting assembly 753 also includes an electrical connector 714 that includes at least two electrical connector pins, a first electrical connector pin 707 and a second electrical connector pin 708. The catheter shaft 861 includes a cavitation bubble chamber 867 having a distal end 868 and a proximal end 869 formed by an outer jacket 864, also shown in phantom using dotted (dashed) lines so that the internal features can be illustrated.Catheter shaft 861 includes a first cavitational solution tube 870 having a distal end 871 and forming a portion of a first cavitational solution lumen or cavity 872, a second cavitational solution tube 873 having a distal end 874 and forming a portion of a second cavitational solution lumen or cavity 875, a guidewire lumen 878 sized to accommodate a guidewire for use during an interventional procedure, a guidewire tube 879 having a distal end 880 and forming a portion of lumen 878, a first conductor 881 positioned partially within lumen 872 of first cavitational solution tube 870, a distal end 882 of first conductor 881, and a second conductor 883 positioned partially within lumen 875 of second cavitational solution tube 873. Catheter shaft 861 also includes a series of electrodes for the purpose of creating shock waves that generate a spark, arc, or plasma channel across an electrode gap formed therein. Catheter shaft 861 includes distal electrode 886, intermediate electrode 861, and proximal electrode 888, where electrode gap 889 is formed between distal electrode 886 and intermediate electrode 887, where electrode gap 890 is formed between intermediate electrode 887 and proximal electrode 888, where distal electrode 886 is electrically connected to first conductor 881 via crimp connector 891, and proximal electrode 888 is electrically connected to second conductor 883 via crimp connector 892. Catheter shaft 861 includes elongate element 894, distal electrode fixation element 895, intermediate electrode fixation element 896, and proximal electrode fixation element 897, which help position and fix electrodes 886, 887, and 888 within cavitation bubble chamber 867 adjacent the length of first cavitation solution tube 870. The catheter shaft 861 includes a first cavitation solution tube proximal extension 876 and a second cavitation solution proximal extension 877, which are connected to the first cavitation solution tube 870 and the second cavitation solution tube 873 at a location proximal to the cavitation bubble chamber 867.The lumen of first cavitation solution tube proximal extension 876 also forms a portion of first cavitation solution lumen 872 when first cavitation solution lumen 872 extends proximally, and the lumen of second cavitation solution tube proximal extension 877 also forms a portion of second cavitation solution lumen 875 when second cavitation solution lumen 875 extends proximally.

[0193] Figure 56 is a partial schematic cross-sectional view of a medical device catheter 860 through a portion of the cavitation bubble chamber 867 or CS15 as illustrated in Figure 55, showing the guidewire tube 879, the guidewire lumen 878, the first conductor 881, the second conductor 883, the first cavitation solution tube 870, the first cavitation solution lumen 872, the second cavitation solution tube 873, the second cavitation solution lumen 875, the distal end of the second cavitation solution tube 874, and the outer jacket 864 of the catheter shaft 861, the first longitudinal centerline axis 748 of the catheter shaft 861, the second longitudinal centerline axis 863 of the cavitation bubble chamber 867, and the third longitudinal centerline axis 866 of the guidewire lumen 878. The catheter shaft 861 is typically a long tube containing one or more lumens and one or more electrical conductors, and the shaft has a first longitudinal centerline axis 748. The first longitudinal centerline axis 748 of the catheter shaft 861 can be conceptualized as a line tracing the center of a cross-section of the catheter shaft 861 along the length of the catheter shaft 861. The second longitudinal centerline axis 863 of the cavitation bubble chamber 867 can be conceptualized as a line tracing the center of a cross-section of the cavitation bubble chamber 867 along the length of the cavitation bubble chamber 867. The third longitudinal centerline axis 866 of the guidewire lumen 878 can be conceptualized as a line tracing the center of a cross-section of the guidewire lumen 878 along the length of the guidewire lumen 878.

[0194] The medical device catheter 860 of FIGS. 55-56 is a catheter similar to the previously described medical device catheter 760 and functions in a similar manner; it can also be conceptualized as an integrated, single, or "one-piece" design version of an assembled modular catheter system that includes an intravascular lithotripsy (IVL) adapter attached to the medical device catheter. Instead of two modules attached together to combine catheter features with a cavitation bubble chamber at the distal end to deliver shockwave energy, the medical device catheter 860 may integrate IVL features in a "non-modular" or one-piece design. The distal end 862 of the medical device catheter 860 is intended to be inserted into a body cavity, such as a blood vessel, artery, vein, or duct, to deliver shockwave energy. The proximal end 719 is intended to remain outside the patient's body and is where the user interfaces with the medical device catheter 860, such as connecting a high-voltage pulse generator and circulating cavitation solution to the distal end 862.

[0195] 55-56 , cavitation bubble chamber 867 is formed by medical device catheter 860 and outer jacket 864 at distal end 862 of catheter shaft 861. In one embodiment, cavitation bubble chamber 867 has a distal end 868 and a proximal end 869 and may house distal electrode 886, intermediate electrode 887, proximal electrode 888, and a portion of first cavitation solution tube 870, for example, forming part of first cavitation solution lumen 872. Electrodes may be positioned along the length of cavitation bubble chamber 867 to create two (2) electrode gaps, such as first electrode gap 889 and second electrode gap 890. In this example, a portion of second cavitation solution lumen or cavity 875 is formed by second cavitation solution tube 873 such that cavitation solution, such as saline solution, can circulate from first cavitation solution fitting 717, through first cavitation solution lumen 872, through cavitation bubble chamber 867 and second cavitation solution lumen 875, and exit via second cavitation solution fitting 718. In this manner, cavitation solution can circulate through cavitation bubble chamber 867 on a continuous or semi-continuous basis during the intravascular lithotripsy process.

[0196] In the example illustrated in Figures 55-56, when first conductor 881 is electrically connected to the positive channel of high-voltage pulse generator 457 (as shown and described with respect to Figure 22) and second conductor 883 is electrically connected to the negative channel of pulse generator 457, and a sufficiently high voltage pulse is applied across the electrode gaps to complete the high-voltage pulse circuit, electrical arcing or sparking across each electrode gap can create individual shock waves and associated cavitation bubbles. Continuous or semi-continuous circulation of the cavitation solution as described facilitates sufficient removal of the generated cavitation bubbles to allow subsequent arcing and shock wave generation at the frequency required for the intravascular lithotripsy process. For the purposes of intravascular lithotripsy, a shock wave generation frequency of 1 to 10 Hz is preferred. The first conductor 881 is electrically connected at its proximal end 719 to a first electrical connector pin 707 and to a distal electrode 886 via an electrical connector 891, which is an intermediate conductor element attached to portions of both the first conductor 881 and the distal electrode 886, providing electrical continuity. A similar electrical connector 892 electrically connects a portion of the proximal electrode 888 to a second conductor 883. The second conductor 883 is also electrically connected at its proximal end 719 to a second pin 708 of the electrical connector 714. Non-limiting examples of electrical connectors 891 and 892 include metal bands that can be mechanically attached to create electrical connectivity or continuity, such as by a crimping or swaging process. Alternatively, brazing or soldering can be used to create electrical connectivity or continuity. Examples of suitable materials for the electrical connectors 891 and 892 include copper, stainless steel, aluminum, gold and gold alloys, and platinum and platinum alloys. An advantage of gold, platinum, or alloys thereof is that electrical connectors 891 and 892 also serve as radiopaque landmarks for cavitation bubble chamber 867 during use. The electrodes are shown as round wires, but may also be, by way of non-limiting example, flat wires, or stranded wires, or tubular extrusions, small or fine wires bundled together to form a conductor.

[0197] 55-56, first cavitation solution lumen 872, created in part by first cavitation solution tube 870, is fluidly continued through a larger lumen created by first cavitation solution tube proximal extension 876 at a location proximal to cavitation bubble chamber 867. Similarly, second cavitation solution lumen 873, created in part by second cavitation solution tube 873, is fluidly continued through a larger lumen created by second cavitation solution tube proximal extension 877 at a location proximal to cavitation bubble chamber 867. Transitioning to a larger lumen proximal to cavitation bubble chamber 867 has the advantage of reducing cavitation solution fluid flow resistance during use, such that a lower pressure is required for an equivalent fluid velocity through cavitation bubble chamber 867. The distal ends 871 and 874 of the first cavitation solution tube 870 and the second cavitation solution tube 873 are respectively a first distal opening of the first cavitation solution lumen 872 and a second distal opening of the second cavitation solution lumen 875, which terminate within the cavitation bubble chamber 867. The distal end 871 of the first cavitation solution tube 870 is near or at the distal end of the cavitation bubble chamber 867, and the distal end 874 of the second cavitation solution tube 873 is at or near the proximal end of the cavitation bubble chamber 867, at a position proximal to the most proximal electrode gap 890, so that filling the cavitation bubble chamber 867 with cavitation solution via the first cavitation solution lumen 872 will help to facilitate removal of any generated cavitation bubbles by discharging the cavitation solution through the second cavitation solution lumen 875 and any lumen proximally and fluidly connected to the second cavitation solution lumen 875, such as the lumen created by the second cavitation solution tube proximal extension 877.

[0198] 55-56, first conductor 881 is positioned within a portion of lumen 872, which portion is formed by first cavitation solution tube 870 and at least a portion of the lumen of first cavitation solution tube proximal extension 876. For example, first conductor 881 can exit first cavitation solution tube proximal extension 876 at a location between the proximal end of cavitation bubble chamber 867 and proximal end 219 of medical device catheter 860. Similarly, as shown in the figures, second conductor 883 is positioned within a portion of lumen 875, which portion is formed by second cavitation solution tube 873 and at least a portion of the lumen of second cavitation solution tube proximal extension 877. By separating the first conductor 881 and the second conductor 883, either or both of the conductors can be constructed of an uninsulated conductive material, sometimes referred to as a bus wire, such as uninsulated bare copper wire or tinned copper wire. Alternatively, either the first conductor 881 or the second conductor 883 can include an insulated wire, sometimes referred to as a magnet wire, such as an insulated copper wire.

[0199] In the example illustrated in FIGS. 55-56 , the outer jacket 864 of the catheter shaft 861 has a “triangular” cross-sectional shape in the region of the cavitation bubble chamber 867, transitioning to a more rounded cross-sectional shape proximal to the cavitation bubble chamber 867. The catheter cross-section is more typically uniformly round along the length of the catheter shaft. An advantage of this configuration is that it minimizes the cross-sectional area of ​​the catheter shaft 861 in the region of the cavitation bubble chamber 867. A smaller cross-section is typically easier to navigate through narrow stenoses during vascular interventional surgical procedures using a catheter device such as the one illustrated in FIGS. 55-56 . The “triangular” cross-sectional shape in the region of the cavitation bubble chamber 867 accommodates both the guidewire tube 879 and the cavitation bubble chamber 867. As illustrated, the outer jacket 864 of the catheter shaft 861 transitions 865 from a "triangular" cross-sectional shape near the distal end 868 of the cavitation bubble chamber 867 to a smaller profile that matches the size of the guidewire lumen 878 at the distal tip of the catheter shaft 861. Furthermore, the "triangular" cross-sectional shape of the outer jacket 864 accommodates the "oblong" cross-sectional shape of the cavitation bubble chamber 867, in which the width dimension of the cross-sectional profile shape of the cavitation bubble chamber 867 is greater than the height dimension. For example, the width dimension may be 0.034 inches and the height dimension may be 0.019 inches. In the illustrated example, the width of the outer jacket 864, which forms the "triangular" cross-sectional shape of the catheter shaft 861, may be 0.042 inches, while the height may be 0.053 inches. These dimensions accommodate a cavitation bubble chamber 867 and guidewire lumen 878 suitable for, for example, a 0.018-inch guidewire. If the guidewire lumen 878 is suitable for a 0.014 inch guidewire, the height of the "triangular" cross-sectional shape may be 0.049 inches.The "oblong" cross-sectional shape of cavitation bubble chamber 867 is designed to accommodate first cavitation solution tube 870 and second cavitation solution tube 873, as illustrated, in a "side-by-side," or parallel, configuration, in which first conductor 881 and second conductor 883 are within first cavitation solution lumen 872 and second cavitation solution lumen 875. The "triangular" geometry of the cross-sectional profile shape of outer jacket 864 in the region of cavitation bubble chamber 867 has or occupies a larger dimension of the triangular geometry across cavitation bubble chamber 867 than the portion of the triangular geometry in guidewire lumen 878. As illustrated, the second longitudinal centerline axis 863 of the cavitation bubble chamber 867 is offset from the first longitudinal centerline axis 748 of the catheter shaft 861, which is also offset from the third longitudinal centerline axis 866 of the guidewire lumen 878, such that the three (3) longitudinal centerline axes 748, 863, and 866 are offset in the elevation or vertical direction, as illustrated. The outer jacket 864 may comprise a thermoplastic polymer such as PEBAX or nylon.

[0200] 55-56, distal electrode 886, intermediate electrode 887, and proximal electrode 888 are positioned parallel to first cavitation solution tube 870 and biased toward the bottom side of cavitation bubble chamber 867, or the side closest to guidewire tube 879. As illustrated, this biased positioning is provided by elongated element 894, which is also positioned parallel to both first cavitation solution tube 870 and electrodes 886, 887, and 888. As illustrated, elongated element 894 is above electrodes 886, 887, 888 and is positioned closer to the side of cavitation bubble chamber 867 that is farther from guidewire tube 879. As a non-limiting example, elongate element 894 is typically a long, narrow fiber or filament constructed from a non-conductive material such as a polymer, e.g., PEEK, PET, PEBAX, nylon, or PVDF. Elongate element 894, electrodes 886, 887, 888, and first cavitation solution tube 870 are positioned and secured together by three (3) fixation elements: distal electrode fixation element 895, middle electrode fixation element 896, and proximal electrode fixation element 897. A non-limiting example of a fixation element is a thin-walled polyester (PET) heat shrink extrusion that is cut to length, positioned as shown, and heated to restore the heat shrink to a smaller size and hold the components together as positioned. Alternatively, fixation elements 895, 896, and 897 may be constructed of a thermoplastic polymer such as PEBAX that, via a reflow heating process using FEP heat shrink, encases electrodes 886, 887, and 888 and the required portions of elongated element 894. Alternatively, fixation elements 895, 896, and 897 may be constructed of a suitable adhesive, where first cavitation solution tube 870, electrodes 886, 887, and 888, and elongated element 894 are secured in the required positions and held in place while the adhesive or glue is applied and cured.As an alternative configuration, instead of a single elongated element 894 spanning all three (3) electrodes, three (3) individual elongated elements 894 can be individually positioned next to electrodes 886, 887, 888.

[0201] In an alternative example, the guidewire lumen 879 may exit the catheter shaft 861 at a location between the distal end 862 and the proximal coupling assembly 753, which may be useful in a rapid-exchange (RX) catheter version. An example of this type of rapid-exchange (RX) is illustrated in the rapid-exchange (RX) intravascular lithotripsy (IVL) adapter 510, as shown with reference to FIGS. 17-20. In this rapid-exchange (RX) example, the guidewire 516 exits at a location 515 proximal to the proximal end 527 of the cavitation bubble chamber, so that the cavitation solution can be returned via the lumen 463 of the central tube 462, where the lumen 463 is fluidly connected to the cavitation bubble chamber, as illustrated by the cavitation bubble chamber 867.

[0202] FIG. 57 is an enlarged detailed view of the distal portion of the medical device catheter 900 and catheter shaft 901, illustrating the distal end 862 having an outer jacket 864 and tapered transition 865 shown fictitiously as a dotted line so that the internal features of the distal end 862 of the catheter shaft 861 can be illustrated. Medical device catheter 900 is similar to medical device catheter 860 and includes the same features at the first longitudinal centerline axis 748 of the catheter shaft 901 and proximal end 719 as shown with reference to FIG. 40 for medical device catheter 760, and a proximal coupling assembly 753 includes a first cavitation solution coupling 717 and a second cavitation solution coupling 718 connected to a first cavitation solution lumen or cavity 872 and a second cavitation solution lumen or cavity 875 that, as described in further detail below, creates a fluid flow path or connection extending between a cavitation bubble chamber 867 and the first cavitation solution coupling 717 and the second cavitation solution coupling 718. Coupling assembly 753 also includes an electrical connector 714 that includes at least two electrical connector pins, i.e., a first electrical connector pin 707 and a second electrical connector pin 708. The catheter shaft 901 includes a cavitation bubble chamber 867 having a distal end 868 and a proximal end 869 formed by an outer jacket 864, also shown in phantom with dotted (dashed) lines so that its internal features can be illustrated. Similarly, a portion of a second cavitation solution lumen or cavity 875 is formed by the outer jacket 864 and also shown in phantom with dotted (dashed) lines.Catheter shaft 901 includes a first cavitational solution tube 870 having a distal end 871 and forming a portion of a first cavitational solution lumen or cavity 872, a second cavitational solution tube 873 having a distal end 874 and forming a portion of a second cavitational solution lumen or cavity 875, a guidewire lumen 878 sized to accommodate a guidewire for use during an interventional procedure, a guidewire tube 879 having a distal end 880 and forming a portion of lumen 878, a first conductor 881 positioned partially within first cavitational solution lumen 872, a second conductor 883 positioned adjacent a portion of second cavitational solution tube 873, and a distal end 884 of second conductor 883. Catheter shaft 901 also includes a series of electrodes for the purpose of creating shock waves that generate a spark, arc, or plasma channel across an electrode gap formed therein. The catheter shaft 901 includes a distal electrode 905, two (2) intermediate electrodes 861, and a proximal electrode 906, wherein an electrode gap 908 is formed between the distal electrode 905 and the distal intermediate electrode 887, an electrode gap 909 is formed between the distal intermediate electrode 887 and a more proximal intermediate electrode 887, and an electrode gap 910 is formed between the more proximal intermediate electrode 887 and the proximal electrode 906, and wherein the distal electrode 905 is electrically connected to a first conductor 881 and the proximal electrode 906 is electrically connected to a second conductor 883. The catheter shaft 901 includes an elongated element 894 spanning two (2) intermediate electrodes 887, a distal electrode fixation element 895, two (2) intermediate electrode fixation elements 896, and a proximal electrode fixation element 897, which serves to position and fix the distal electrode 905, both intermediate electrodes 887, and the proximal electrode 906 within the cavitation bubble chamber 867 and adjacent the length of the first cavitation solution tube 870.The catheter shaft 901 includes a first cavitation solution tube proximal extension 876 and a second cavitation solution proximal extension 877, and is fluidly connected to the first cavitation solution tube 870 and the second cavitation solution tube 873 at a location proximal to the cavitation bubble chamber 867.

[0203] Figure 58 is a partial schematic cross-sectional view of a medical device catheter 900 through a portion of the cavitation bubble chamber 867 or CS16 as illustrated in Figure 57, showing the guidewire tube 879, the guidewire lumen 878, the first conductor 881, the second conductor 883, the first cavitation solution tube 870, the first cavitation solution lumen 872, the second cavitation solution lumen 875, the outer jacket 864 of the catheter shaft 901, the first longitudinal centerline axis 748 of the catheter shaft 901, the second longitudinal centerline axis 863 of the cavitation bubble chamber 867, and the third longitudinal centerline axis 866 of the guidewire lumen 878. The catheter shaft 901 is typically a long tube containing one or more lumens and one or more electrical conductors, and the shaft has the first longitudinal centerline axis 748. The first longitudinal centerline axis 748 of the catheter shaft 901 can be conceptualized as a line tracing the center of a cross-section of the catheter shaft 901 along the length of the catheter shaft 901. The second longitudinal centerline axis 863 of the cavitation bubble chamber 867 can be conceptualized as a line tracing the center of a cross-section of the cavitation bubble chamber 867 along the length of the cavitation bubble chamber 867. The third longitudinal centerline axis 866 of the guidewire lumen 878 can be conceptualized as a line tracing the center of a cross-section of the guidewire lumen 878 along the length of the guidewire lumen 878.

[0204] Figure 59 is a partial schematic cross-sectional view of a medical device catheter 900 through a portion of the cavitation bubble chamber 867 or CS17 as illustrated in Figure 57, showing the guidewire tube 879, the guidewire lumen 878, the first conductor 881, the first cavitation solution tube 870, the first cavitation solution lumen 872, the intermediate electrode 887, the elongated element 894, the intermediate electrode fixation element 896, the outer jacket 864 of the catheter shaft 901, the first longitudinal centerline axis 748 of the catheter shaft 901, the second longitudinal centerline axis 863 of the cavitation bubble chamber 867, and the third longitudinal centerline axis 866 of the guidewire lumen 878.

[0205] Figure 60 is a partial schematic cross-sectional view of a medical device catheter 900 through a portion of the cavitation bubble chamber 867 or CS17 as illustrated in Figure 57, showing the guidewire tube 879, the guidewire lumen 878, the first conductor 881, the first cavitation solution tube 870, the first cavitation solution lumen 872, the intermediate electrode 887, the elongated element 894, an alternative version of the intermediate electrode fixation element 896, the outer jacket 864 of the catheter shaft 901, the first longitudinal centerline axis 748 of the catheter shaft 901, the second longitudinal centerline axis 863 of the cavitation bubble chamber 867, and the third longitudinal centerline axis 866 of the guidewire lumen 878.

[0206] The medical device catheter 900 of Figures 57-60 is a catheter similar to the medical device catheter 860, functions in a similar manner, and shares many of the same features as that described with reference to Figures 55-56. The distal end 862 of the medical device catheter 900 is intended to be inserted into a body cavity, such as a blood vessel, artery, vein, or duct, to deliver shockwave energy. The proximal end 719 is intended to remain outside the patient's body and is where a user interfaces with the medical device catheter 900, such as connecting a high-voltage pulse generator and circulating cavitation solution to the distal end 862.

[0207] 57-60 , cavitation bubble chamber 867 is formed by medical device catheter 900 and outer jacket 864 at distal end 862 of catheter shaft 901. In one embodiment, cavitation bubble chamber 867 has a distal end 868 and a proximal end 869 and may house therein a distal electrode 905, two (2) intermediate electrodes 887, a proximal electrode 906, and a portion of first cavitation solution tube 870, which forms part of, for example, first cavitation solution lumen 872. Electrodes may be positioned along the length of cavitation bubble chamber 867 to create three (3) electrode gaps, such as a distal or first electrode gap 908, a middle or second electrode gap 909, and a proximal or third electrode gap 910. As illustrated, the intermediate electrode 887 is shown as a round wire, but by way of non-limiting examples, it may be a flat wire, or stranded wire, or a tubular extrusion, or small or thin wires bundled together to form a conductive electrode. The distal electrode 905 and the proximal electrode 906 are comprised of a tubular conductive element 903 electrically connected to portions of the first conductor 881 and the second conductor 883, respectively. Electrical connectivity between the tubular conductive element 903 and the first conductor 881 and the second conductor 883 can be achieved through means such as, by way of non-limiting examples, crimping, swaging, brazing, soldering, or bonding. For example, as illustrated, the distal end 884 of the second conductor 883 is flush with the distal end surface of the tubular conductive element 903 of the proximal electrode 906; thus, arcing may occur between either the second conductor 883 or the tubular conductive element 903 and the intermediate electrode 887 in the electrode gap 910.For example, if the second conductor 883 is constructed of copper and the tubular conducting element 903 of the proximal electrode 906 is constructed of a metal alloy having a higher melting temperature than copper, such as platinum / iridium, arcing may be initiated between the distal end 884 of the second copper conductor 883 and the intermediate electrode 887, but because the melting temperature of copper is lower than that of platinum / iridium, this may change to arcing between the platinum / iridium tubular conducting element 903 as the number of arcing events increases due to wear or erosion at the distal end 884 of the copper second conductor 883. In an alternative example, the distal end 884 of the second conductor 883 can be positioned proximally relative to the distal end face of the tubular conducting element 903 of the proximal electrode 906, so that arcing will only occur between the tubular conducting element 903 of the proximal electrode 906 and the intermediate electrode 887 in the electrode gap 910. In this alternative example, the distal portion of the tubular conducting element 903 of the proximal electrode 906 may be plastically compressed to change shape at the distal end from a circular tubular shape to an oblong tubular shape, with the walls of the tubular conducting element 883 locally touching or approaching one another, which may be advantageous by restricting the arc discharge to occur over a smaller cross-sectional area.

[0208] In the example illustrated in Figures 57-60, the first conductor 881 exits the distal end 871 of the first cavitation solution tube 870 and is bent or curved in the opposite direction so that the end face of the distal electrode 905 is positioned facing the end face of the intermediate electrode 887, as illustrated, to form an electrode gap 908.

[0209] In the example illustrated in Figures 57-60, the second conductor 883 and second cavitation solution lumen 875 exit the proximal end 869 of the cavitation bubble chamber 867 as a "side-by-side" or parallel pair, where the second cavitation solution lumen 875 is formed by a cavity in the outer jacket 864 located just proximal to the proximal end 869 of the cavitation bubble chamber 867 and then transitions into the lumen of the second cavitation solution tube 873, instead of a coaxial configuration as illustrated in Figures 56-56. As illustrated, at proximal end 869 of cavitation bubble chamber 867, second cavitation solution lumen 875 has a second distal opening into cavitation bubble chamber 867, and first cavitation solution lumen 872, formed in part by first cavitation solution tube 870, has a first distal opening at a distal portion of cavitation bubble chamber 867 near distal end 868 of cavitation bubble chamber 867. Second conductor 883 runs proximally along second cavitation solution tube 873 and second cavitation solution tube proximal extension 877. 57-59 is that it allows for a sufficiently large effective fluid flow lumen 875 size for the required cavitation solution fluid flow while minimizing the size of the second cavitation solution tube 873, where the effective lumen size is the size of the unobstructed cross section, e.g., the effective fluid flow lumen size of the first cavitation solution tube 870 is the cross-sectional area of ​​the lumen of the first cavitation solution tube 870 minus the cross-sectional area of ​​the first conductor 881. For the contemplated medical device catheters 860 and 900, the minimum effective fluid flow lumen size expected to allow sufficient cavitation solution fluid flow is approximately 0.05 mm 2The size or cross-sectional area corresponds to a square millimeter (millimeters squared). The configuration of the second cavitation solution tube 873 and second conductor 883 illustrated in Figures 57-59 allows for the width dimension of the "oblong" cross-sectional shape of the cavitation bubble chamber 867 to be minimized, allowing the wall thickness of the outer jacket 864 to be thicker closer to the electrode gaps 908, 909, and 910. Shock waves are characterized by a high peak shock front of very short duration. The magnitude of the peak pressure is typically proportional to the inverse of the distance from the origin of the shock wave. In the illustrated exemplary configuration, the peak pressure is higher closer to the electrode gaps 908, 909, and 910; therefore, features closer to the electrode gaps must be designed through material and geometry selection to withstand these peak pressures. 57-60 allow for thicker walls immediately adjacent the electrode gap and gradually thinner walls less adjacent the electrode gap, e.g., where the walls of cavitation bubble chamber 867 formed by outer jacket 864 are adjacent first cavitation solution tube 870 and first cavitation solution lumen 872. As illustrated, this is accomplished by offsetting second longitudinal centerline 863 of cavitation bubble chamber 867 away from the plane formed by first longitudinal centerline 748 of catheter shaft 901 and third longitudinal centerline 866 of guidewire lumen 878 to a position closer to first cavitation solution lumen 872 formed by first cavitation solution tube 870, and by reducing the width dimension of the "oblong" cross-sectional shape of cavitation bubble chamber 867.As a result, the walls of the cavitation bubble chamber 867 formed by the outer jacket 864 are parallel to the plane formed by the first longitudinal centerline 748 of the catheter shaft 901 and the third longitudinal centerline 866 of the guidewire lumen 878 and closer to the electrode gaps 908, 909, and 910, and have a wall thickness ranging from approximately 0.008 inches to 0.011 inches, and the opposite wall of the cavitation bubble chamber 867 formed by the outer jacket 864 is parallel to the plane formed by the first longitudinal centerline 748 of the catheter shaft 901 and the third longitudinal centerline 866 of the guidewire lumen 878, but is further away from the electrode gaps 908, 909, and 910 and has a wall thickness ranging from approximately 0.004 inches to 0.006 inches. 59 , the thicker wall of cavitation bubble chamber 867 is the curved wall of cavitation bubble chamber 867 on the left side of cavitation bubble chamber 867, and the thinner wall of cavitation bubble chamber 867 is the curved wall of cavitation bubble chamber 867 on the right side, which is also the side of first cavitation solution lumen 872 formed in part by first cavitation solution tube 870. Electrode gaps 908, 909, and 910 are biased closer to the thicker wall illustrated on the left side and are positioned next to first cavitation solution lumen 872 formed in part by first cavitation solution tube 870, which is positioned closer to the bottom surface of the cavitation bubble chamber closest to guidewire lumen 878. Because the peak pressure of the shock wave front decreases as it moves away from the electrode gaps, it is advantageous to position the electrode gaps 908, 909, and 910 farther away from the thinner wall portions of the cavitation bubble chamber 867 and closer to the thicker wall portions of the cavitation bubble chamber 867, where the electrode gaps are also the locations of shock wave origin.By configuring the location of the electrode gap to be biased closer to the thicker wall portion of the cavitation bubble chamber 867, the high voltage pulse generator 457 (as shown with respect to FIG. 22) can be operated at peak voltages greater than about 3000 volts, or between about 3000 volts and about 7000 volts, preferably about 5000 volts, to maximize performance. The thinner walls of the cavitation bubble chamber 867 that are too close to the electrode gap are at risk of rupturing at peak voltages greater than about 3000 volts.

[0210] 59, the "oblong" cross-sectional shape of the cavitation bubble chamber 867 formed by the outer jacket 867 has a width dimension of the shape that is greater than its height dimension. For example, the width dimension may be 0.029 inches and the height dimension may be 0.019 inches.

[0211] 57-60, the configuration of intermediate electrode 887, elongated element 894, first cavitation solution tube 870, and intermediate electrode fixation element 896 positions the electrode gap 909 closer to the thicker wall cross section of outer jacket 864 and the bottom of cavitation bubble chamber 867. An example of a suitable electrode fixation element 896 is polyester (PET) heat shrink extrusion or tubing cut to length and having a wall thickness on the order of 0.0005 inches. Cut-to-length PET heat shrink tubing is advantageous because the three elements, i.e., intermediate electrode 887, elongated element 894, and first cavitation solution tube 870, can be positioned as desired within the length of PET heat shrink tubing (electrode fixation element 896) as they are manufactured (not retrieved) and then heated to a temperature that restores or shrinks the PET shrink tubing to a smaller diameter that holds the intermediate electrode 887, elongated element 894, and first cavitation solution tube 870 in the desired relative positions. In one variation, the elongated element 894 can be manufactured from a polymer, such as PEEK (Polyether ether ketone), that has a melting temperature higher than the temperature for shrinking PET heat shrink extrusions and higher than the melting temperature of PET (electrode fixation element 896), so that the geometry of the elongated element 894 remains substantially unchanged after the described assembly process. Alternative variations include reflowing the elongated element 894 from a polymer having a melting temperature between the recovery temperature of the PET heat shrink extrusion (electrode fixation element 896) and the melting temperature of the PET heat shrink extrusion (electrode fixation element 896), resulting in a portion of the elongated element 894 melting and providing a better bond between the electrode 887, the first cavitation solution tube 870, and the electrode fixation element 896; for example, the elongated element 894 can be constructed from PEBAX, nylon, or PVDF (polyvinylidene fluoride).While FIG. 57 illustrates an elongated element 894 spanning both intermediate electrodes 887, an equally effective configuration includes two individual elongated elements 894 on each individual intermediate electrode 887 to position the intermediate electrodes 887 as needed.

[0212] 60, an alternative to this configuration is where the electrode fixation element 896 only fixes the elongated element 894 to the electrode 887, but the elongated element 894 and electrode 887 are positioned within the cavitation bubble chamber 867 adjacent to the first cavitation solution tube 870, but are not fixed directly to the first cavitation solution tube 870. In this alternative configuration, the elongated element 894 spans the distal electrode 905, two (2) intermediate electrodes 861, and the proximal electrode 906, in a manner similar to the configuration illustrated in FIG. 55. This configuration may be advantageous when assembling the elements within the cavitation bubble chamber 867.

[0213] An alternative configuration similar to that illustrated in Figures 57-60 is one in which the second conductor 883 exits the proximal end 869 of the cavitation bubble chamber 867 next to the second cavitation solution tube 873 as illustrated, but re-enters the second cavitation solution tube proximal extension 877, where the second cavitation solution tube 873 enters the lumen of the second cavitation solution tube proximal extension 877, meaning that the second conductor enters the second cavitation solution lumen 875 at the second cavitation solution tube proximal extension 877. This can be advantageous because the width of the cavitation bubble chamber 867 can be minimized for the reasons explained above, but the second conductor 883 is protected by the additional barrier of the second cavitation solution tube proximal extension 877, as illustrated in Figures 55-56.

[0214] FIG. 61 is an enlarged detailed view of an alternative configuration of the intermediate electrode 887 of the distal portion of the medical device catheter 900 and catheter shaft 901 as illustrated in FIGS. 57-60, with like reference numbers referring to common features.

[0215] Figure 62 is a partial schematic cross-sectional view of a medical device catheter 900 through a portion of the cavitation bubble chamber 867 or CS18 as illustrated in Figure 61, showing the first conductor 881, the first cavitation solution tube 870, the first cavitation solution lumen 872, the intermediate electrode 887 of the alternative configuration shown in Figure 61, the intermediate electrode fixation element 896, the outer jacket 864 of the catheter shaft 901, the first longitudinal centerline axis 748 of the catheter shaft 901, and the second longitudinal centerline axis 863 of the cavitation bubble chamber 867.

[0216] Figure 63 is a partial schematic cross-sectional view of a medical device catheter 900 through a portion of the cavitation bubble chamber 867 or CS18 as illustrated in Figure 61, showing the first conductor 881, an alternative configuration of the first cavitation solution tube 870, the first cavitation solution lumen 872, another alternative configuration of the intermediate electrode 887, the intermediate electrode fixation element 896, the outer jacket 864 of the catheter shaft 901, the first longitudinal centerline axis 748 of the catheter shaft 901, and the second longitudinal centerline axis 863 of the cavitation bubble chamber 867.

[0217] The medical device catheter 900 of FIGS. 61-63 illustrates an alternative intermediate electrode 887 configuration in which the elongated element 894 is not required to position the electrode gaps 908, 909, and 910 within the cavitation bubble chamber 867 at the locations illustrated in FIG. 59 . The intermediate electrode 887 is configured with a narrow portion 911 for creating an electrode gap within the cavitation bubble chamber 867 where the wall of the outer jacket 864 has a desired thickness. As illustrated in the partial schematic cross-sectional view of FIG. 62 , the intermediate electrode 867 has a curved cross-section to match the outer diameter of the first cavitation solution tube 870. As an alternative to this configuration, FIG. 63 illustrates an alternative non-circular cross-section of the first cavitation solution tube 870, which can be characterized as having a “D” shape. FIG. 63 also illustrates an alternative shape for the intermediate electrode 887, where the cross-section can be characterized as having a flat or rectangular shape. 64-66 illustrate one example of a cavitation solution fluid management assembly 915 suitable for use with a medical device catheter, according to one embodiment of the present disclosure.64-66 illustrate a first cavitation fluid fitting 717, a second cavitation fluid fitting 718, a first 3-way stopcock 916 fluidly connected to the first cavitation fluid fitting 717 via a section of tubing 925, a second 3-way stopcock 918 fluidly connected to the second cavitation fluid fitting 718 via a section of tubing 925, a third 3-way stopcock 920 fluidly connected to the first 3-way stopcock 916 by a section of tubing 925, and a third 3-way stopcock 920 fluidly connected to the second 3-way stopcock 918 by a section of tubing 925. 9A schematically illustrates a first syringe 917 fluidly connected to a third 3-way stopcock 920 via a section of tubing 925, a second syringe 919 fluidly connected to the fourth 3-way stopcock 922 via a section of tubing 925, a section of tubing 925 fluidly connecting the first 3-way stopcock 916 and the second 3-way stopcock 918, a third syringe 921 fluidly connected to the third 3-way stopcock 920, and a fourth syringe 923 fluidly connected to the fourth stopcock 922. Three-way stopcocks are a type of three-way valve commonly used in managing fluid connections during catheter-based interventional surgical procedures. An example of a three-way stopcock suitable for use with embodiments of the present disclosure is described in U.S. Patent No. 5,074,334 to Onodera. 64-66 further schematically illustrate medical device catheter 900, including first and second cavitational solution lumens 872, 875, and cavitational bubble chamber 867. As shown in FIG.

[0218] 64 is suitable for fluidly connecting a first syringe 917 to a first cavitation solution fitting 717 and simultaneously fluidly connecting a second syringe 919 to a second cavitation solution fitting 718. As illustrated in FIG. 64, stopcocks 916 and 918 are closed to tubing 925 between the first stopcock 916 and the second stopcock 918 such that the first three-way stopcock 916 is fluidly connected only to the second three-way stopcock 918 via the catheter 900. As illustrated, third and fourth three-way stopcocks 920 and 922 are configured to fluidly connect a first syringe 917 to first three-way stopcock 916 via tubing 925, and to fluidly connect a second syringe 919 to second three-way stopcock 918 via tubing 925. This configuration is suitable for circulating cavitation solution from first syringe 917 through first cavitation solution lumen 872, through cavitation bubble chamber 867 of medical device catheter 900, and then back to second syringe 919 through second cavitation solution lumen 875. Third and fourth syringes 921 and 923 are bypassed.

[0219] The cavitation solution fluid management assembly 915 as configured in FIG. 65 is suitable for fluidly connecting the first syringe 917 to the second syringe 919 while bypassing the medical device catheter 900, and the third syringe 921 and fourth syringe 923.

[0220] The cavitation solution fluid management assembly 915 as configured in FIG. 66 is suitable for fluidly connecting the third syringe 921 to the fourth syringe 923 via the medical device catheter 900 while blocking or bypassing the first syringe 917 and the second syringe 919.

[0221] The medical device catheter 900 and fluid management system 915 of Figures 64-66 schematically represent the entire fluid system. To prepare the entire fluid system for use, the cavitation bubble chamber 867, the internal cavitation solution lumens of the medical device catheters 872 and 875, and the lumens of the cavitation solution fluid management assembly 915 are flushed with air and filled with cavitation solution, while simultaneously filling the syringe 917 with cavitation solution and retaining only minimal cavitation solution in the second syringe 919, as configured in Figure 64. An exemplary use scenario as illustrated involves using a first syringe 917 and a second syringe 919 of the same size, e.g., 10 milliliter syringes. During use, the first syringe 917 plunger advances (creating pressure) at a given speed while the second syringe 919 plunger is retracted (creating a vacuum) at the same speed. This forward and backward movement of the syringe plunger can be accomplished via a pair of syringe pumps (dual-acting syringe pump module) designed to operate simultaneously but in opposite directions. The average fluid velocity of the cavitation solution through the cavitation bubble chamber 867 is preferably greater than approximately 80 mm / s. To evacuate the chamber of cavitation solution between high-voltage electrical pulses, the preferred average fluid velocity through the cavitation bubble chamber should be greater than the length of the cavitation bubble chamber 867 times the pulse frequency; thus, for a 40 mm length and a 2 Hz pulse frequency, for example, the fluid velocity should be greater than 80 mm / s. This ensures that most cavitation bubbles are removed between pulses.Because these procedures occur in an operating room within a sterile field, a preferred procedure for setting up the cavitation solution fluid management assembly 915 is for the operator to fill the system with cavitation solution within the sterile field while also flushing or purging the system with air while ensuring that the first syringe 917 is near its capacity and the second syringe 919 is nearly empty of cavitation solution but purged of air, and then the first syringe 917 and second syringe 919 can be handed from the sterile field to a technician operating outside the sterile field so that the first syringe 917 and second syringe 919 can be loaded into associated syringe pumps designed to operate in the manner described above. If during use the first syringe 917 becomes empty or nearly empty, meaning the syringe plunger is fully depressed, or the second syringe 919 becomes full of cavitation solution, the cavitation solution fluid management assembly 915 can be configured as shown in FIG. 65, where the first three-way stopcock and the second three-way stopcock are configured to fluidly connect the first syringe 917 and the second syringe 919 while bypassing the medical device catheter 900. In the configuration of FIG. 65, the plunger of the second syringe 919 can be advanced while the plunger of the first syringe 917 is retracted at the same rate to "refill" the first syringe 917 with cavitation solution. "Refilling" the first syringe 917 in this manner can be advantageous, for example, if a second medical device catheter is intended to be used during the procedure, allowing the operator to prepare the cavitation solution fluid management assembly 915 for the new medical device catheter without risking the sterile field.Also, during use, it may be advantageous to be able to flush the internal cavity or lumen of the medical device catheter 900 but maintain the first syringe 917 and second syringe 919 outside of the sterile field within the dual acting syringe pump module, in which case the fluid management system 915 may be configured as illustrated in Figure 66, where the third and fourth syringes are maintained inside the sterile field as shown but are fluidly connected. During use, it may be advantageous to have syringes 921 and 923 available to flush or prepare a new medical device catheter 900 for use or to add / remove cavitation solution from the system.

[0222] As previously mentioned, during use, the fluid movement of the cavitation solution is from the first syringe 917, through the medical device catheter 900, and back to the second syringe 919, such that the fluid movement of the cavitation solution flows from the distal end to the proximal end of the cavitation bubble chamber 867. The medical device catheter 900 can also be effective if the fluid movement of the cavitation solution is reversed, from the second syringe 919, through the medical device catheter 900, and back to the first syringe 917.

[0223] In the embodiments of Figures 46-66, cavitation solution can be circulated by pressurizing the first cavitation solution lumen 812 or 872 with a syringe filled with fresh cavitation solution at the first cavitation solution fitting 717 at the proximal end 719 and applying suction at the second cavitation solution fitting 718 to help evacuate the cavitation solution within the cavitation bubble chamber 815 or 867 via the second cavitation solution lumen 817 or 875. A syringe or similar vacuum generating device can be attached to achieve suction. Sufficient cavitation solution circulation can be achieved by simultaneously pressurizing the first cavitation solution fitting 717 and applying suction at the second cavitation solution fitting 718, as well as applying only pressure or only suction if there is a sufficient reservoir of cavitation solution connected to the first cavitation solution fitting 717.

[0224] In the exemplary electrode configurations illustrated in Figures 44-51, the electrodes can be secured or positioned using a suitable adhesive or polymer, via a reflow heating process or heat shrink tubing similar to that described in Figures 55-63. Additionally, the tubes 816, 833, and 852 forming the cavitation bubble chamber 815 can include circular or non-circular cross sections and can be fabricated from suitable polymers such as, by way of non-limiting example, polyimide, PEBAX, or nylon.

[0225] It will be understood that any of the IVL adapter structures, elements, configurations, features, or functions disclosed and discussed above with respect to FIGS. 1-28 may similarly be incorporated into or utilized in single or "one-piece" catheter designs, including and beyond those expressly discussed with reference to FIGS. 29-66. In other words, the embodiments described with reference to FIGS. 29-66 are non-limiting examples of how IVL features and functions may be incorporated into such single catheter designs. Similarly, the embodiments described with reference to FIGS. 29-66 may also be incorporated into modular catheter systems such as those described above and are not limited to the specific examples discussed with reference to FIGS. 1-28. It will also be understood that any common or shared elements, functions, or features of any particular embodiment or aspect described with reference to FIGS. 1-54 may likewise be used and can be used in combination or conjunction with any of the other embodiments or aspects described herein, and that some shared elements, while not sharing the same reference number or designation, may nevertheless be the same, similar, or functionally equivalent and may be similarly effective for the same or similar applications.

[0226] A potential advantage of the single design embodiments of the present disclosure is that they can be configured to have a smaller profile, thereby allowing medical device catheters to be used for certain procedures where a modular system may not be suitable depending on the location of treatment and patient vasculature considerations.

[0227] Additionally, other alternatives may be understood regarding the specific structure, configuration, and function of the medical device catheter modular system or unitary design with respect to any of the above-described embodiments with reference to Figures 1-66. For example, other suitable electrode set configurations include electrode configurations including end-to-end and parallel electrode configurations, or combinations of end-to-end and parallel electrodes. This may include, for example, electrode ends positioned or configured to create an electrode gap with parallel electrodes. Electrodes may be formed from wire, tubing, formed or cut conductive material, sheet metal, or many other materials and forms. For example, one or more of the electrodes may include one or more "tooth-like," "pointed," sharp, laser-cut, shaped, or thread-type features along their length or at their ends that can concentrate current density for targeted or optimized electrical arc discharge.

[0228] Furthermore, it will be understood by those skilled in the art that any suitable electrode gap or spacing between the electrodes can be configured to generate sufficient arcs, shock waves, and cavitation bubbles for a lithotripsy procedure, and is not limited to about 100 to about 500 micrometers. The relative surface areas (including their ratios) and geometric shapes of the electrodes can also be configured to generate sufficient arcs, shock waves, and cavitation bubbles.

[0229] Calcium-rich lesions within the vasculature are a problem that affects the cardiovascular health of many people. Lithotripsy, specifically the use of shock waves to break up calcium, can be an effective method for altering vascular calcium structure and improving outcomes during angioplasty procedures. In accordance with the present disclosure, novel modular catheter systems and adapters, as well as a single design option, are provided to allow physicians to perform lithotripsy procedures more effectively and flexibly.

[0230] While the present invention has been described with reference to exemplary embodiment(s), those skilled in the art will recognize that various modifications may be made without departing from the scope of the invention and that equivalents may be substituted for elements thereof. In addition, modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is not intended that the invention be limited to the particular embodiment(s) disclosed, but rather, the invention is intended to include all embodiments falling within the scope of the appended claims.

Claims

1. A medical device catheter, a catheter shaft including a proximal end configured to remain outside a patient's body and a distal end configured to enter the patient's body, and a first longitudinal centerline axis; a cavitation bubble chamber at the distal end of the medical device catheter, the cavitation bubble chamber including a proximal portion and a distal portion and extending along a second longitudinal centerline axis; a first cavitation solution lumen extending into the cavitation bubble chamber and having a first distal opening positioned at the distal portion of the cavitation bubble chamber; a second cavitation solution lumen having a second distal opening positioned in the proximal portion of the cavitation bubble chamber; a first cavitation solution fitting at the proximal end of the medical device catheter and in fluid communication with the first cavitation solution lumen; a second cavitation solution fitting at the proximal end of the medical device catheter and in fluid communication with the second cavitation solution lumen; a first conductor and a second conductor and at least one electrode gap therebetween, the first conductor being in electrical communication with a proximal end of the electrode gap and the second conductor being in electrical communication with a distal end of the electrode gap; a guidewire lumen including a third longitudinal centerline axis; The medical device catheter, wherein the first longitudinal centerline axis, the second longitudinal centerline axis, and the third longitudinal centerline axis are each offset from one another.

2. The medical device catheter of claim 1 , wherein the electrode gap is positioned within the cavitation bubble chamber but outside the first cavitation solution lumen.

3. The medical device catheter of claim 2 , wherein the electrode gap is positionally biased and offset from the second longitudinal centerline axis.

4. The medical device catheter of claim 3 , wherein the electrode gap is further positionally biased toward the third longitudinal centerline axis.

5. The medical device catheter of claim 3 , wherein the electrode gap is positionally biased within the cavitation bubble chamber by a tube that forms at least a portion of the first cavitation solution lumen.

6. 4. The medical device catheter of claim 3, wherein the electrode gap is positionally biased within the cavitation bubble chamber by an elongated element positioned inside the cavitation bubble chamber but outside the first cavitation solution lumen.

7. The medical device catheter of claim 6 , wherein the elongate element spans an area adjacent the electrode gap.

8. The medical device catheter of claim 6 , wherein a tube forms at least a portion of the first cavitation solution lumen and further comprises a fixation element for fixing the tube and the elongate element together within the cavitation bubble chamber.

9. 4. The medical device catheter of claim 3, wherein the cavitation bubble chamber is formed by an outer jacket of the catheter shaft and includes a non-uniform wall thickness such that the wall thickness on one side of the cavitation bubble chamber is thicker than the wall thickness on another side of the cavitation bubble chamber, and the electrode gap is positionally biased toward the side having the thicker wall thickness.

10. The medical device catheter of claim 3 , wherein the cavitation bubble chamber comprises an oblong cross-sectional shape.

11. The medical device catheter of claim 10 , wherein the second longitudinal centerline axis is offset from a plane formed by the first longitudinal centerline axis and the third longitudinal centerline axis.

12. The medical device catheter of claim 1 , wherein the first conductor extends through at least a portion of the first cavitation solution lumen and exits the first distal opening into the cavitation bubble chamber.

13. The medical device catheter of claim 1 , wherein the second conductor extends through at least a portion of the second cavitation solution lumen.

14. The medical device catheter of claim 1 , wherein the second conductor is outside the second cavitation solution lumen at the proximal end of the cavitation bubble chamber.

15. 10. The medical device catheter of claim 1, configured to flow cavitation solution from the first cavitation solution fitting through the first cavitation solution lumen, the first distal opening, the cavitation bubble chamber, the second distal opening, the second cavitation solution lumen, and the second cavitation solution fitting.

16. 16. The medical device catheter of claim 15, further configured to flow the cavitation solution through the cavitation bubble chamber at a preferred average fluid velocity greater than the product of the length of the cavitation bubble chamber and the electrical pulse frequency used to create an arc discharge across the electrode gap.

17. 10. The medical device catheter of claim 1, configured to operate at a voltage greater than about 3000 volts to create an arc discharge across the electrode gap.

18. 10. The medical device catheter of claim 1, configured to operate at a voltage greater than about 3000 volts and less than about 7000 volts to create an arc discharge across the electrode gap.

19. 10. The medical device catheter of claim 1, wherein the cross-sectional profile of the catheter in the region of the cavitation bubble chamber has a generally triangular geometric shape, and the cavitation bubble chamber occupies a portion of the triangular geometric shape that is larger than the guidewire lumen.

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