Systems and methods for efficient endovascular lithotripsy

Abstract

An intravascular lithotripsy device is disclosed. The device may include a balloon assembly that expands to provide shock waves for any available lumen. The balloon assembly may be shielded by an outer catheter that provides a smooth surface to facilitate advancement through the lumen. A locking mechanism for securing a double catheter, which may be integrated with any of the devices described, is also described herein.

Description

Technical Field

[0001] Claim of Priority

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 518,864, filed on August 10, 2023, entitled "SYSTEM AND METHOD FOR EFFICIENT INTRAVASCULAR LITHOTRIPSY", the entire content of which is incorporated herein by reference.

[0002] Incorporation by Reference

[0002] All publications and patent applications mentioned in this specification are incorporated herein by reference in their entirety to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference.

[0003]

[0003] The methods and apparatuses described in this specification may relate to intravascular lithotripsy techniques. More specifically, the methods and apparatuses described in this specification may relate to an apparatus that enables a surgeon to efficiently and easily perform a lithotripsy technique.

Background Art

[0004]

[0004] The treatment of obstructive lesions in coronary and peripheral arteries has been the main focus of vascular therapy for decades. Such treatments were initially performed using balloon angioplasty. Eventually, coronary stents and peripheral stents were also used to enhance long-term revascularization of arterial occlusions. One of the major limitations of both angioplasty and stenting relates to the inability to properly expand the device in areas where vascular calcification is present. <0********><0********><0********>

[0005] Numerous devices have been devised to process calcium. These include rotational atherectomy and orbital atherectomy, and more recently, the emergence of endovascular lithotripsy (IVL). IVL procedures generate shock waves within a blood vessel or other lumen as a means of breaking down or "breaking up" calcified areas. The shock waves are typically centrally located within a balloon catheter, which is typically expanded during endovascular lithotripsy to further enhance the effect of the shock waves.

[0006]

[0006] Conventional IVL procedures and techniques use bulky, rigid balloons and electrodes, which can be extremely difficult to deliver to diseased, calcified, and winding coronary and / or peripheral arteries. In addition, the bulkiness and rigidity of conventional IVL techniques limit balloon length, which makes treating longer segments of calcified vessels time-consuming and inefficient. [Overview of the project] [Means for solving the problem]

[0007]

[0007] This specification describes apparatus, systems, and methods for performing endovascular lithotripsy (IVL) on a patient. In some examples, IVL treatment may be performed through a balloon assembly, which may be connected to an internal catheter and selectively covered by an external catheter. In this way, the external catheter can protect and / or shield the balloon assembly from exposure to an artery or vein. This shielding facilitates the insertion and advancement of the balloon assembly. In some cases, the shielding allows for a longer balloon assembly compared to conventional IVL assemblies.

[0008]

[0008] Any device described herein may include an internal catheter and an external catheter. The internal catheter may include a tapered element and a balloon assembly. The tapered element may be a distal element located on the distal end of the internal catheter. The tapered element may be elongated to allow for easy insertion and advancement within the patient's body. The balloon assembly may be located proximal to the tapered element. Generally, the balloon assembly may include one or more pairs of electrodes. The electrodes may receive high-voltage energy pulses used to generate shock waves by emitting an electric arc.

[0009]

[0009] The outer catheter may include a lumen configured to coaxially surround the inner catheter and a tip positioned on the distal end of the outer catheter. The tip is configured to slidably engage with the landing zone of the tapered element. Generally, the tip can be made from any available material. Generally, the material may be flexible and pliable and may seal the tapered element (especially when in contact with the landing zone of the tapered element). The material of the tip may resist fish-mouthing, which can occur when the IVL assembly is advanced through curved blood vessels in the patient's body.

[0010]

[0010] In any of the devices described herein, the balloon assembly may be configured to expand or inflate in the presence of a liquid or gas. Generally, the balloon assembly is expanded after the balloon assembly is exposed by the retraction of the outer catheter (relative to the inner catheter).

[0011]

[0011] In any of the devices described herein, the balloon assembly may be configured to be housed within the outer catheter (e.g., covered, shielded, surrounded, etc., by the outer catheter) when the tip of the outer catheter is in contact with the landing zone of the tapered element.

[0012]

[0012] Furthermore, in any of the devices described herein, the outer catheter may further include an alignment window, while the inner catheter further includes a midshaft marker configured to appear within the alignment window when the tip of the outer catheter is in contact with the landing zone of the tapered element. In this way, the midshaft marker can provide positional information regarding the balloon assembly and the outer catheter when the balloon assembly is inserted into an artery or vein.

[0013]

[0013] Any device described herein may include two or more markers configured to indicate the position of the balloon assembly relative to the outer catheter when the intravascular lithotripsy device is inserted into the patient. These markers may be associated with (marked on) the inner or outer catheter. In some variations, the two or more markers may remain outside the patient's body, particularly when the balloon assembly is advanced within the patient's body.

[0014]

[0014] As described herein, a control axis (such as an outer catheter control axis) may be connected to the proximal end of the outer catheter. The control axis may be used to control the position of the outer catheter. In some examples, the inner catheter may include a set of first marker bands configured to indicate when the balloon assembly is inside the outer catheter. The marker bands may be compared to bands on the control axis. In some other examples, the inner catheter may include a set of second marker bands configured to indicate when the balloon assembly extends beyond the outer catheter.

[0015]

[0015] Any device described herein may include a hub connected to an inner catheter and a locking clip connected to a control shaft. The locking clip may be used to lock the device into a first configuration or a second configuration. In the first configuration, the balloon assembly is located outside the outer catheter, and in the second configuration, the balloon assembly is located inside the outer catheter.

[0016]

[0016] In any of the devices described herein, two or more electrodes (within the balloon assembly) may be formed from a flexible circuit, conductive ink, or a combination thereof. Furthermore, in any example, the tapered element may be about 3 centimeters in length. In any of the devices described herein, the tip of the outer catheter and the tapered element form a smooth outer surface when the tip of the outer catheter is slidably engaged with the landing zone of the tapered element.

[0017]

[0017] Any device described herein may assist in the removal of the inner catheter. For example, the inner catheter may be configured to be removed (pulled out) from the outer catheter. In some modifications, the balloon assembly may have a diameter between 2 and 8 millimeters when expanded or inflated. In some other modifications, the balloon assembly may have a length of at least 20 millimeters.

[0018]

[0018] Methods for treating a patient using shock waves are described herein. Generally, the method may use any of the devices described herein, such as an IVL system including an internal catheter, an external catheter, and a balloon assembly. The method may include the steps of: percutaneously inserting an endovascular lithotripsy device into a patient's blood vessel, wherein the endovascular lithotripsy device includes a balloon assembly connected to an internal catheter and an external catheter configured to surround the balloon assembly; advancing the endovascular lithotripsy device to a treatment area; retracting the external catheter to expose the balloon assembly; and inflating the balloon assembly to deliver shock waves to the treatment area.

[0019]

[0019] In any method described herein, the step of advancing the intravascular lithotripsy device may include locking the inner catheter and the outer catheter together. The catheters may be locked together using any available locking mechanism, including those described herein. In addition, any method described herein may include the steps of unlocking the inner catheter from the outer catheter and moving the outer catheter distally based on one or more markers placed on the inner catheter and the outer catheter. In some examples, the step of retracting the outer catheter may include observing the markers against a transparent alignment window placed on the outer catheter.

[0020]

[0020] Any method described herein may include the step of deflating the balloon assembly to withdraw the inner catheter from the outer catheter.

[0021]

[0021] Locking mechanisms for temporarily locking or restraining two or more catheters or shafts together are described herein. Locking or restraining the shafts together allows the balloon assembly to be shielded by the outer catheter or to be exposed to the outer catheter.

[0022]

[0022] Generally, the locking mechanisms described herein may be called locks or proximal locks. These locks may be configured to be adjustablely positioned above and around two or more shafts. In some cases, these locks may be mounted above the shafts (e.g., fixed above the shafts) without requiring them to slide along the shafts. In some examples, the locks may hold shafts of different diameters in a tandem row. The locks may include separate channels for securing each of the shafts. The channels may be of various sizes to accommodate shafts of various sizes. The channels may be configured to grip or hold the shafts. In some cases, the channels may be lined or include a textured material and / or a gripping surface (e.g., a high-tack surface). In some cases, the channels may include a compressible material (e.g., open-cell foam or closed-cell foam).

[0023]

[0023] A locking mechanism for temporarily holding two or more shafts together may include a cylindrical body configured to receive two or more shafts through a central opening, a flexible grommet configured to hold two or more shafts together in response to a compressive force, and a plunger configured to provide a variable compressive force to the flexible grommet.

[0024]

[0024] In any of the locking mechanisms described herein, the flexible grommet can be configured to receive two or more shafts through a central opening that is concentric with the cylindrical body. In some examples, the plunger can include a button configured to lock the plunger in a position away from the flexible grommet. Any of the locking mechanisms described herein can include a spring configured to provide a biasing force that opposes the plunger. In some variations, the spring can be configured to provide a biasing force that opposes the plunger. In some other variations, the plunger can be configured to provide a compressive force based at least in part on the biasing force. Any of the locking mechanisms described herein can include a slot in the body configured to hold the plunger away from the grommet.

[0025]

[0025] In some examples, the locking mechanism can include a clamp and a body. The clamp can include a positioning pin, a first guide tube, a second guide tube, and an arm connecting the first guide tube to the second guide tube, and the first guide tube and the second guide tube can be configured to receive two or more shafts. The body can be flexibly connected to the clamp and can include a slot movably connected to the pin.

[0026]

[0026] In any of the locking mechanisms described herein, the arm can be further configured to angularly dispose the first guide tube relative to the second guide tube and collectively hold two or more shafts.

[0027]

[0027] In any of the locking mechanisms described herein, the arm is further configured to receive a deflecting force, reduce the angle between the first guide tube and the second guide tube, and allow two or more shafts to slide freely within the first guide tube and the second guide tube. In some examples, the first guide tube and the second guide tube include slots configured to receive two or more shafts.

[0028]

[0028] Yet another locking mechanism is described. This locking mechanism may include a cam and a body. The body may include a slot configured to receive two or more shafts and an opening configured to receive the cam. The cam is configured to contact two or more shafts and hold them against the body. The cam may include a handle and may be configured to rotate by only one-fourth of a full rotation to hold two or more shafts against the body. In any of the locking mechanisms described herein, the cam may include an elastomeric stopper for contacting the shaft.

[0029]

[0029] In any of the locking mechanisms described herein, the elastomeric stopper is at least one of rubber, thermoplastic urethane, or silicon. Further, in any of the locking mechanisms described herein, the cam may be configured to allow the shaft to move freely in a first position and to hold the shafts together in a second position.

[0030]

[0030] Still another locking mechanism is described. This locking mechanism may include a locking clip connected to a first shaft and a locking ring connected to a second shaft and including a groove configured to receive the locking clip. In any of the locking mechanisms described herein, the locking clip may be laser welded to the second shaft. In other examples, the locking clip is nitinol.

[0031]

[0031] In any of the locking mechanisms described herein, the locking clip may be formed by the second shaft. In some examples, the locking ring is at least one of a machined material, a welded material, or an insert molded material. In some other examples, the second shaft is formed from nitinol.

[0032]

[0032] Another locking mechanism is disclosed. This locking mechanism may include a notch feature formed on a first catheter axis and a snap ring connected to a second catheter axis and configured to accept the notch feature. In any locking mechanism described herein, the first catheter axis is formed from nitinol.

[0033]

[0033] A locking mechanism is described. This locking mechanism may include a clamshell body and an elastomer pad. The clamshell body may include a first member, a second member, and a hinge member configured to movably connect the first member to the second member. The elastomer pad may be configured to fit into the first member and to hold two or more axes together.

[0034]

[0034] In any locking mechanism described herein, the second member may include at least one groove configured to receive at least one shaft. In some examples, the clamshell body may be injection molded.

[0035]

[0035] In any locking mechanism described herein, the clamshell body may include a latching section. The latching section may include an inclined ramp member formed on the edge of a first member positioned directly opposite the hinge member, and a beam member formed on the edge of a second member positioned directly opposite the hinge member, configured to engage with and detachably connect to the inclined ramp member. In some examples, the inclined ramp member is configured to deflect the beam member when the first member is rotated relative to the second member. Furthermore, in some cases, the beam member may be configured to engage with the locking surface of the inclined ramp member.

[0036]

[0036] In any locking mechanism described herein, the elastomer pad is at least one of thermoplastic urethane or silicone.

[0037]

[0037] All of the methods and apparatus described herein can be used in any combination to obtain the benefits that are discussed herein and described herein.

[0038]

[0038] Further understanding of the features and advantages of the methods and apparatus described herein will be gained by referring to the following detailed description and accompanying drawings that describe exemplary embodiments. [Brief explanation of the drawing]

[0039] [Figure 1]

[0039] This is a simplified block diagram of an exemplary endovascular lithotripsy (IVL) system. [Figure 2]

[0040] This block diagram shows some exemplary components of the generator shown in Figure 1. [Figure 3A]

[0041] This is an illustrative diagram of the distal portion of a catheter assembly. [Figure 3B]

[0042] This is a simplified block diagram of a catheter assembly configured for shock wave therapy. [Figure 4]

[0043] Figure 4A shows the modes of the catheter assembly in Figure 3. Figure 4B shows the modes of the catheter assembly in Figure 3. [Figure 5]

[0044] Figure 5A shows details regarding the alignment of catheters in a catheter assembly, such as the catheter assembly shown in Figure 3. Figure 5B shows details regarding the alignment of catheters in a catheter assembly, such as the catheter assembly shown in Figure 3. Figure 5C shows details regarding the alignment of catheters in a catheter assembly, such as the catheter assembly shown in Figure 3. [Figure 6]

[0045] Figure 6A is a detailed view of the internal catheter. Figure 6B is a detailed view of the external catheter control axis. [Figure 7A]

[0046] This is a first illustrative diagram of the control axes of the internal and external catheters. [Figure 7B]

[0047] This is a detailed diagram of the inner and outer catheters in the first configuration. [Figure 7C]

[0048] This is a second exemplary diagram of the catheter and the external catheter control axis. [Figure 7D]

[0049] This is a detailed diagram of the inner and outer catheters in the second configuration. [Figure 8]

[0050] Figure 8A shows various components of the catheter assembly arranged in the first configuration. Figure 8B shows various components of the catheter assembly arranged in the first configuration. Figure 8C shows various components of the catheter assembly arranged in the first configuration. [Figure 9]

[0051] Figure 9A shows various components of the catheter assembly arranged in the second configuration. Figure 9B shows various components of the catheter assembly arranged in the second configuration. Figure 9C shows various components of the catheter assembly arranged in the second configuration. [Figure 10]

[0052] Figure 10A shows a hub that can be used in conjunction with the catheter assembly shown in Figure 3. Figure 10B shows a hub that can be used in conjunction with the catheter assembly shown in Figure 3. [Figure 11]

[0053] Figure 11A shows an exemplary embodiment of the latching mechanism. Figure 11B shows an exemplary embodiment of the latching mechanism. [Figure 12A]

[0054] This is a diagram showing the first intermediate axis locking mechanism. [Figure 12B] This is a diagram showing the first intermediate axis locking mechanism. [Figure 12C] This is a diagram showing the first intermediate axis locking mechanism. [Figure 12D] This is a diagram showing the first intermediate axis locking mechanism. [Figure 12E]This is a diagram showing the first intermediate axis locking mechanism. [Figure 12F] This is a diagram showing the first intermediate axis locking mechanism. [Figure 13]

[0055] Figure 13A shows the second intermediate shaft locking mechanism. Figure 13B shows the second intermediate shaft locking mechanism. [Figure 14]

[0056] Figure 14A shows the third intermediate shaft locking mechanism. Figure 14B shows the third intermediate shaft locking mechanism. [Figure 15]

[0057] Figure 15A shows the fourth intermediate shaft locking mechanism. Figure 15B shows the fourth intermediate shaft locking mechanism. Figure 15C shows the fourth intermediate shaft locking mechanism. [Figure 16]

[0058] Figure 16A shows the fifth intermediate shaft locking mechanism. Figure 16B shows the fifth intermediate shaft locking mechanism. [Figure 17]

[0059] Figure 17A shows the sixth intermediate shaft locking mechanism. Figure 17B shows the sixth intermediate shaft locking mechanism. [Figure 18]

[0060] Figure 18A shows the seventh intermediate shaft locking mechanism. Figure 18B shows the seventh intermediate shaft locking mechanism. [Figure 19A]

[0061] This is a diagram showing the eighth intermediate shaft locking mechanism. [Figure 19B] This is a diagram showing the eighth intermediate shaft locking mechanism. [Figure 19C] This is a diagram showing the eighth intermediate shaft locking mechanism. [Figure 19D] This is a diagram showing the eighth intermediate shaft locking mechanism. [Figure 19E] This is a diagram showing the eighth intermediate shaft locking mechanism. [Figure 20]

[0062] This flowchart illustrates an exemplary method for treating a patient using an IVL system. [Modes for carrying out the invention]

[0040]

[0063] In general, intravascular lithotripsy can be used to treat calcified arteries or other lumens. Until now, the length and / or diameter of the lithotripsy balloon used to deliver shock waves have been limited to allow insertion and placement through blocked or twisted arteries.

[0041]

[0064] Endovascular lithotripsy systems that allow the use of longer lithotripsy balloons than conventional lithotripsy balloons are described herein. The increased length (and, in some cases, increased diameter) may be made possible by a unique arrangement of catheters that may be used to insert the lithotripsy balloon and place it at the treatment site or treatment area. In some examples, the lithotripsy balloon may be encased by an outer catheter to allow it to pass through difficult areas when moving into the treatment area. In the treatment area, the outer catheter may be retracted (or the inner catheter may be extended) to expose and deploy the lithotripsy balloon. In addition, several methods for collectively securing two or more catheters or axes that may be used during lithotripsy are described herein.

[0042]

[0065] Figure 1 is a simplified block diagram of an exemplary endovascular lithotripsy (IVL) system 100. The IVL system 100 may include a generator 102, a cable 110, a catheter hub 120, a catheter assembly 130, and a balloon assembly 140. The generator 102 may include systems and devices for controlling one or more aspects of the IVL system 100, including the operation of the balloon assembly 140. For example, the generator 102 may supply energy (voltage and / or current) to the balloon assembly 140. The energy may be used to generate one or more arcs between electrodes enclosed within the balloon assembly 140. The arcs may deliver shock waves (pressure waves) to the treatment area or treatment region. The energy may be supplied from the generator 102 to the balloon assembly 140 through a detachably connected cable 110. The cable 110 may be connected to the catheter hub 120, and the catheter hub 120 may be connected to the balloon assembly 140 through one or more catheters (included in the catheter assembly 130).

[0043]

[0066] Any fluid for inflating the balloon assembly 140 can be administered through the catheter hub 120. In addition, the catheter hub 120 may allow a clinician (internist or other trained personnel) to control and percutaneously introduce the balloon assembly 140 and catheter assembly 130 into the patient. The catheter hub 120, catheter assembly 130, and balloon assembly will be discussed in more detail below with respect to Figures 2-11.

[0044]

[0067] Figure 2 is a block diagram 200 showing some exemplary components of the generator 102 in Figure 1. A power input 202 (for example, for conductive connection to a wall port or another power source) is connected to a power module 224 and an internal power supply 208. As shown in Figure 2, the power module 224 may include a high-voltage DC-DC converter 210, a high-voltage capacitor and transistor switch 212, a voltage and / or current measuring unit 216, and a device identification unit 222 configured to determine whether a connected catheter is an authorized device when the catheter is connected via the catheter connector 204. For example, the generator 102 may be configured to disable the energy output to the catheter connector 204 when an unverified device is connected. In some examples, the catheter connector 204 may be connected to a cable (such as cable 110 in Figure 1) and a balloon assembly (such as balloon assembly 140). In this way, the generator can supply energy to the balloon assembly 140 to generate an electric arc.

[0045]

[0068] The generator 102 may include memory, as well as one or more processors, such as a processor 218 and / or a user interface control processor 226. The UI control processor 226 is configured to provide functionality to the user interface 234 of the energy generator 102, such as a display screen, touch screen, buttons, or other manual control devices, which enable a user (e.g., a clinician) to operate the generator 102.

[0046]

[0069] Figure 3A is an exemplary diagram of the distal portion of the catheter assembly 300. In some examples, the catheter assembly 300 may include a balloon assembly 140 and at least a portion of the catheter assembly 130, both of which are shown in Figure 1. The catheter assembly 300 may include an inner catheter 310 and an outer catheter 320. In addition, a balloon assembly 340 may be connected to the inner catheter 310. The inner catheter 310 may be slidably connected to the outer catheter 320. The outer catheter 320 may have a lumen configured to coaxially surround the inner catheter and to be slidably connected to the inner catheter. In some examples, the inner catheter 310 may be fitted into and surrounded by the outer catheter 320. In some embodiments, the inner catheter 310 may be formed from or include any lubricating material, including a material containing a polytetrafluoroethylene (PTFE) component.

[0047]

[0070] The balloon assembly 340 is shown in its expanded (deployed) configuration in Figure 3A. The catheter assembly 300 can be advanced toward the patient's treatment area as the inner catheter 310 and outer catheter 320 are guided into the patient's body. The inner catheter 310 may include a tapered tip 311, a tapered element 312, and a landing zone 313. Some or all of the inner catheter 310 may include a flexible coiled shaft. The tapered tip 311 is located distally, furthest from the catheter hub (not shown). The tapered tip 311 may be flexible and non-traumatic in shape. In some variants, the tapered tip 311 may be radiopaque to allow for easy and accurate tracking within the patient's body during treatment. A tapered element 312, which may be located between the tapered tip 311 and the landing zone 313, may be the portion of the inner catheter 310 that transitions from a relatively narrow tapered tip to a relatively wide landing zone 313. In some cases, the tapered element 312 may allow the inner catheter 310 to be inserted into a blood vessel or other lumen and guided through any restrictions or obstacles within the blood vessel or other lumen.

[0048]

[0071] The outer catheter 320 may include a tip 321 positioned distally on the outer catheter 320. The tip 321 may be flexible and radiopaque. When the balloon assembly 340 is not deployed, the balloon assembly 340 is housed within the outer catheter 320. For example, the outer catheter 320 may be advanced relative to the inner catheter 310 until the tip 321 coincides with and contacts the landing zone 313. In some variants, the tip 321 and the landing zone 313 may be sized for a tight fit. The tip 321 may be formed of a conforming material and / or elastomer to resist "fish mouthing" as the inner catheter 310 and outer catheter 320 are advanced within the patient's body.

[0049]

[0072] Figure 3B shows a simplified block diagram of a catheter assembly 80 configured for shock wave treatment. The catheter assembly may include a balloon assembly 86, which may be another example of a balloon assembly 340. Electrodes 82 and 84 may be connected to a generator, such as a high-voltage pulse generator 30. The high-voltage pulse generator 30 may be entirely or partially contained within the generator 102 in Figures 1 and 2.

[0050]

[0073] The catheter assembly 80 may further include a sensor 85 for detecting reflected signals. Reflected signals from calcified plaque may be processed by a processor 88 to determine the quality of calcification and pulverization of the lesion.

[0051]

[0074] Figures 4A and 4B show different modes of the catheter assembly in Figure 3. Specifically, Figure 4A shows the first mode of the exemplary catheter assembly 400. Similar to Figure 3, the catheter assembly 400 may include a balloon assembly 410, an outer catheter 420, and an inner catheter 431. When operating in the first mode, the balloon assembly 410 can be expanded. In some variations, fluid may be delivered through the catheter to fill and expand the balloon assembly 410.

[0052]

[0075] The balloon assembly 410 may include one or more conductors and one or more IVL electrodes. For example, the balloon of the balloon assembly 410 may include or surround a first wire 411 and a second wire 412. The first wire 411 and the second wire 412 may deliver a high voltage to one or more connected electrodes. In the exemplary catheter assembly 400, the first wire 411 and the second wire 412 may be connected to IVL electrodes 413-416. Each of the IVL electrodes 413-416 may include a separate conductor (not shown) that can be connected to the first wire 411 and the second wire 412. Although four IVL electrodes 413-416 are shown here, in other embodiments the balloon assembly 410 may include any number of available electrodes. In some examples, the balloon assembly 410 may be approximately 20 millimeters long, 30 millimeters long, or any other available length. Furthermore, the balloon assembly 410 may have an expanded (inflated) diameter of 2 to 8 millimeters, but other diameters are also intended.

[0053]

[0076] When a high-voltage signal (e.g., from generator 102 in Figure 1) is connected to the first wire 411 and the second wire 412, an electric arc may be emitted from the IVL electrodes 413-416. The electric arc can propagate a pressure wave from the IVL electrodes 413-416 through the balloon assembly 410. If the balloon assembly 410 is expanded so that the balloon is in contact with the wall of a blood vessel or other lumen, the associated pressure wave can be transmitted circumferentially through the balloon to the wall of the blood vessel or other lumen. In this way, the pressure wave may collide with or otherwise affect areas of calcification in the lumen. In some cases, the pressure wave may enable better patient outcomes related to subsequent angioplasty and / or stenting procedures.

[0054]

[0077] Figure 4B shows a second mode of an exemplary catheter assembly 450. When operating in the second mode, the balloon assembly 410 can be folded as shown. In the second mode, the balloon assembly 410 can be easily fitted into the outer catheter 420. The balloon assembly 410 may include a distal marker band 417 and a proximal marker band 418. In some variants, the distal marker band 417 and the proximal marker band 418 may be radiopaque, in particular to allow for easy and rapid determination and confirmation of the position of the balloon assembly 410 when the balloon assembly is inserted into the patient's body.

[0055]

[0078] Figures 5A to 5C illustrate details regarding the control of catheter-to-catheter alignment in catheter assemblies, such as the catheter assembly 300 in Figure 3. As described above, a portion of the outer catheter may be positioned on the inner catheter such that the distal tip of the outer catheter engages with the landing zone of the inner catheter. This configuration may allow for smooth and easy insertion and passage into the patient's blood vessels or other lumens.

[0056]

[0079] Figure 5A shows a portion of a catheter assembly 500 including an inner catheter 510 and an outer catheter 520. The inner catheter 510 may include an intermediate axis marker 511, while the outer catheter 520 may include an alignment window 521 and an outer catheter control axis 522. The inner catheter 510 can be inserted into the outer catheter 520 and advanced into it. In some cases, the inner catheter 510 is inserted into the outer catheter 520 before the catheter assembly 500 is inserted into the patient. In some variations, the junction between the inner catheter 510 and the outer catheter 520, as shown in Figure 5A, may be located outside the patient's body even when the catheter assembly 500 is being advanced to the treatment position.

[0057]

[0080] To assist clinicians in obtaining and / or determining proper alignment between the inner catheter 510 and the outer catheter 520, clinicians may use an intermediate axis marker 511 and an alignment window 521. The alignment window 521, which may be transparent, may indicate the intermediate axis marker 511 when the alignment between the inner catheter 510 and the outer catheter 520 is correct, so that the distal tip of the outer catheter 520 engages with the landing zone of the distal tip of the inner catheter 510.

[0058]

[0081] Figure 5B shows a portion of the catheter assembly 500 from Figure 5A when the inner catheter 510 is inserted into the outer catheter 520 such that the distal tip 523 of the outer catheter 520 engages with the landing zone of the inner catheter 510 or is otherwise positioned within the landing zone. As shown, the inner catheter 510 can be advanced so that the intermediate axis marker 511 appears inside the alignment window 521. Figure 5B also shows a detail view of the distal tip 523 of the outer catheter 520. In some variations, when the intermediate axis marker 511 is inside the alignment window 521, the distal tip 523 can be positioned within the landing zone of the tapered element 512 of the inner catheter 510, as shown in detail 530. In some variations, the intermediate axis marker 511 may be radiopaque to allow for a more accurate determination of the relationship between the inner catheter 510 and the outer catheter 520.

[0059]

[0082] Figure 5C shows another view of a portion of the catheter assembly 500 in Figure 5B. The inner catheter 510 is inserted into the outer catheter 520 such that the intermediate axis marker 511 is within the alignment window 521. A guide wire port 513, which can receive a guide wire or other instrument, is also shown.

[0060]

[0083] Figures 6A and 6B show detailed views of the inner catheter 600 and the outer catheter control axis 630. As described above, the outer catheter control axis 630 can be connected to the outer catheter. Both the inner catheter 600 and the outer catheter control axis 630 may include markers, which provide the clinician with positional feedback related to the balloon assembly. For example, Figure 6A shows markings on the inner catheter 600. The inner catheter 600 may include two distal bands 610 and two proximal bands 620. In some variations, the outer catheter control axis 630 may include any number of distal bands and / or proximal bands.

[0061]

[0084] A distal band 610 may be applied to a first position of the inner catheter 600. The distal band 610 may be a laser-marked band, a pad-printed band, or a heat-shrinkable base band. The distal band 610 may be approximately 5 mm wide. In some variations, the distal band 610 may be of any feasible width. A region 611 may be present between the distal bands 610. The region 611 separates the distal bands 610. In some embodiments, the region 611 may be approximately 2 mm wide. In other examples, the region 611 may be of any feasible width. The distal band 610 may be used to indicate when the inner catheter 600 is in a first position relative to the outer catheter. In some examples, the first position may be the position where the distal tip of the outer catheter is positioned on the landing zone of the tapered element of the inner catheter 600, as shown in Figure 5B.

[0062]

[0085] The inner catheter 600 may also include a proximal band 620. In some examples, the proximal band 620 may be approximately 10 millimeters long and wide. In some other examples, the proximal band 620 may be any feasible width. A region 621 can separate the proximal band 620. In some examples, the region 621 may be approximately 10 millimeters wide, but any other feasible width is also intended. The proximal band 620 may be used to indicate when the inner catheter 600 is in a second position relative to the outer catheter. In some examples, the second position may be a position where the distal tip of the outer catheter is positioned away from the landing zone and the balloon assembly is exposed and / or expanded. For example, in the second position, the distal tip 421 may be moved away from the landing zone 430, as shown in Figure 4A, to allow the balloon assembly 410 to be positioned on the landing zone 430 of the tapered element. The distal band 610 and the proximal band 620 may be separated by a balloon unsheathing distance. That is, the distal band 610 may be separated from the proximal band 620 by a distance related to exposing or unsheathing the balloon assembly 410. Notably, the distal band 610 and the proximal band 620 may remain outside the patient's body while the patient is undergoing the procedure.

[0063]

[0086] Figure 6B shows a detailed view of the outer catheter control axis 630. The outer catheter control axis 630 may include a marking band 631. The marking band 631 may be formed by laser ablation, masking, pad printing, labeling, or any other feasible method or operation. In some examples, the marking band 631 may be approximately 2 millimeters wide. The marking band 631 may be used in conjunction with a distal band 610 and / or a proximal band 620 to enable the clinician to determine and control the relative position of the outer catheter and the inner catheter 600. The outer catheter control axis 630 may be coated with a lubricating coating, including but not limited to polytetrafluoroethylene (PTFE).

[0064]

[0087] Figure 7A shows a first exemplary Figure 700 of the inner catheter 710 and the outer catheter control axis 720. The inner catheter 710, which may be an example of the inner catheter 600 in Figure 6, may include a distal band 711 and a proximal band 712. The outer catheter control axis 720, which may be an example of the outer catheter control axis 630, may include a marking band 721.

[0065]

[0088] As described above, the marking band 721, together with the distal band 711 and the proximal band 712, can provide the clinician with positional information. As shown, the marking band 721 can be positioned approximately between the distal bands 711, thereby positioning the catheter assembly in a first position or configuration. For example, if the marking band 721 is positioned approximately between the distal bands 711, the distal tip of the outer catheter may be positioned approximately on the landing zone of the tapered tip of the inner catheter 710.

[0066]

[0089] Figure 7B shows a detailed diagram 740 of the inner catheter 710 and outer catheter 723 in the first configuration. The outer catheter 723, which can be connected to an outer catheter control axis (not shown in Figure 7B), can be positioned such that the marking band 721 is located between the distal bands 711. In the first configuration, the distal tip 722 of the outer catheter 723 can be positioned on the landing zone of the tapered tip 713 of the inner catheter 710. Thus, in this first configuration, the catheter assembly can be configured for smooth insertion into the patient's designated location.

[0067]

[0090] Figure 7C shows a second exemplary figure 750 of the inner catheter 710 and the outer catheter control axis 720. The inner catheter 710 and the outer catheter control axis 720 are shown in a second position or configuration. For example, the marking band 721 may be positioned between the proximal bands 712. When the outer catheter control axis 720 is in this positional relationship with the inner catheter 710, the outer catheter may be positioned to expose the balloon assembly.

[0068]

[0091] For example, Figure 7D shows a detailed diagram 790 of the inner catheter 710 and outer catheter 723 in a second configuration. In the second configuration, the outer catheter 723 may no longer be positioned on the landing zone, but instead may be positioned proximal to the landing zone. In some examples, the proximal position of the distal tip of the outer catheter may allow the balloon assembly to be exposed or pushed out from the outer catheter.

[0069]

[0092] Figures 8A to 8C show various components of the catheter assembly 800 arranged in the first configuration. In the first configuration, the balloon assembly connected to the inner catheter can be placed entirely within the outer catheter. As shown in Figure 8A, in the first configuration, the outer catheter 810 can be positioned on the landing zone of the tapered element 821 connected to the inner catheter. In such a configuration, the distal tip 811 of the outer catheter can be positioned to engage with the tapered element 821 of the inner catheter. The inner catheter may be an example of the inner catheter 510 in Figure 5A, and the outer catheter 810 may be an example of the outer catheter 520 in Figure 5A.

[0070]

[0093] As shown in Figure 8B, the intermediate axis marking band 822 of the inner catheter 820 may be positioned within the window of the outer catheter 810. When the intermediate axis marking band is positioned within the window 823, the relationship between the inner catheter 820 and the outer catheter 810 may be such that the balloon assembly is covered or encased by the outer catheter 810.

[0071]

[0094] Figure 8C shows an inner catheter 820 and an outer catheter control axis 812 connected to an outer catheter (not shown). In the first configuration, the outer catheter control axis 812 may be positioned such that the marking band of the outer catheter control axis 812 is located approximately between the distal bands of the inner catheter. When the inner catheter and outer catheter control axis are positioned as shown in Figure 8C, the associated catheter assembly may be positioned in the first configuration such that the balloon assembly is encased by the outer catheter.

[0072]

[0095] Figures 9A to 9C show various components of the catheter assembly 900 arranged in the second configuration. The catheter assembly 900 may include an inner catheter 910, an outer catheter 920, and a balloon assembly 930. In some examples, the inner catheter 910 may be an example of the inner catheter 310, and the outer catheter 920 may be an example of the outer catheter 320, both from Figure 3. In addition, the balloon assembly 930 may be an example of the balloon assembly 410 in Figure 4.

[0073]

[0096] As described above, the second configuration may position the balloon assembly 930, connected to the inner catheter 910, on the other side of the outer catheter 920 and / or outside the outer catheter 920. As shown in Figure 9A, in the second configuration, the balloon assembly 930 connected to the inner catheter 910 is exposed to or withdrawn from the outer catheter 920. In 901, the balloon assembly 930 is shown in an uninflated or folded state. In 902, the balloon assembly 930 is shown in an inflated state. The balloon assembly 930 may be inflated or expanded by the application of a liquid or gas. In some examples, the balloon assembly 930 may have an expanded diameter of 2 to 8 millimeters. In addition, the balloon assembly 930 may have a length of 20 to 30 millimeters.

[0074]

[0097] Figure 9B shows a detail view of a catheter assembly 900 showing an inner catheter 910 and an outer catheter 920. In a second configuration, the inner catheter 910 may be positioned relative to the outer catheter 920 such that the intermediate axis marking band 940 is located on the far side (e.g., distally) of the window 950 on the outer catheter 920. The intermediate axis marking band 940 may be an example of the intermediate axis marking band shown in Figure 8. As illustrated in Figure 8B, if the intermediate axis marking band 940 is within the window 950, the balloon assembly (not shown) may be located within the outer catheter 920. Conversely, if the intermediate axis marking band 940 is located distally to the window 950, the balloon assembly may be located outside or on the far side of the outer catheter 920. In some variations, the inner catheter 910 may be withdrawn from the outer catheter 920. For example, the balloon assembly 930 may be folded after being used to deliver shock waves into the patient's lumen, and the entire inner catheter 910 may be withdrawn. In such cases, the external catheter 920 may be used to deliver medication or other devices (tools, cameras, etc.) to the treatment area.

[0075]

[0098] Figure 9C shows the relationship between the inner catheter 910 and the outer catheter control axis 921 when the catheter assembly 900 is in a second configuration. The outer catheter control axis 921 may include a marking band 922. As described with respect to Figures 7A and 7C, the inner catheter 910 may include a distal band 911 and a proximal band 912. The distal band 911 may be an example of the distal band 711 in Figure 7A, and the proximal band 912 may be an example of the proximal band 712. The distal band 911 and the proximal band 912 may be used in conjunction with the marking band 922 to indicate the relative position of the balloon assembly with respect to the outer catheter (not shown). In Figure 9C, the marking band 922 is positioned between the proximal bands 912 to indicate that the balloon assembly 930 is exposed or located beyond the outer catheter 920. If the marking band 922 is positioned between the distal bands 911, the balloon assembly 930 may be housed within the outer catheter 920.

[0076]

[0099] Figures 10A and 10B show different diagrams of a hub 1000 that may be used in conjunction with the catheter assembly 300 of Figure 3. Generally, the hub 1000 may provide a control surface that a clinician or other user can use to guide and / or control the catheter assembly 300. As shown in Figure 10A, the hub 1000 may include an inflation port 1010. The inflation port 1010 may accept a liquid or gas to inflate a balloon assembly (not shown). In addition, a first end of cable 1020 may be connected to the hub 1000. A second end of cable 1020 may be connected to a generator (not shown), such as the generator 102 of Figure 2. One or more conductors 1030 may be located within cable 1020. The conductors 1030 may conduct a voltage, including a high voltage, from the generator 102 to one or more electrodes in the balloon assembly.

[0077]

[0100] Figure 10B shows a cross-sectional view of the hub 1000. As described above, the balloon assembly can be controlled by the positional relationship between the outer catheter control axis and the inner catheter. In some examples, the inner catheter can be connected to the hub 1000. The outer catheter control axis may be located outside the hub 1000. In some variations, a locking clip (not shown) can be connected to the outer catheter control axis. Furthermore, the locking clip may be detachably attached (e.g., clipped) to the hub 1000 at either the first latch surface 1040 or the second latch surface 1050. This will be described in more detail below in conjunction with Figures 11A and 11B.

[0078]

[0101] Figures 11A and 11B show exemplary embodiments of the latching mechanism 1100. Figure 11A specifically shows the latching mechanism 1100 in a first configuration. In the first configuration, a balloon assembly (not shown) connected to an inner catheter (not shown) can be enclosed or sealed by an outer catheter (not shown).

[0079]

[0102] The locking mechanism 1100 may include a hub 1110 and a locking clip 1120. The hub 1110 may be an example of the hub 1000 shown in Figures 10A and 10B. The hub 1110 may include a first locking surface 1130 and a second locking surface 1140. The locking clip 1120 may be connected to an external catheter control shaft (not shown).

[0080]

[0103] Figure 11A shows the hub 1110 and locking clip 1120 in the first configuration. For example, Figure 11A shows the locking clip 1120 clipped (removably attached) to the first latching surface 1130. In the first configuration, the locking clip 1120 can position the outer catheter so that the balloon assembly (not shown) can be enclosed and sealed by the outer catheter.

[0081]

[0104] Figure 11B shows the locking mechanism 1100 in the second configuration. The locking clip 1120 can be removably attached to the second locking surface 11140. In the second configuration, the locking clip 1120 can position the outer catheter so that the balloon assembly (not shown) can be withdrawn from the outer catheter and exposed.

[0082]

[0105] Figures 12A–12F show a first intermediate axis locking mechanism 1200. The intermediate axis locking mechanism 1200 can temporarily lock or restrain two (or more) catheters or axes 1210 together. The axes 1210 may include an outer catheter control axis and an inner catheter, as shown in Figure 9C. In other examples, the axes 1210 may include any available catheters or axes that are desired to be locked together (e.g., immobile relative to each other). In some embodiments, the intermediate axis locking mechanism 1200 may perform the locking action provided by the latching mechanism 1100 in Figures 11A and 11B.

[0083]

[0106] Figure 12A shows a perspective view of the intermediate shaft locking mechanism 1200. The intermediate shaft locking mechanism 1200 may include a cylindrical body 1220 and a button 1230. The shaft 1210 can be inserted through a central opening concentric with the body 1220.

[0084]

[0107] Figure 12B shows another perspective view of the intermediate shaft locking mechanism 1200. Figure 12B shows a slot 1240 for a button 1230 and a spring 1250 for biasing the button 1230 by providing a sustained force. Note that the button 1230 may be connected to a plunger 1231 that applies a force (such as a bias force) to a flexible (deformable) grommet 1260. The applied force may vary based on the position of the plunger 1231 and / or the button 1230. The grommet 1260 may hold or lock the shaft 1210 together when deformed or otherwise compressed by the plunger 1231. Note that the shaft 1210 passes through an opening concentric with the grommet 1260 and the body 1220. Figures 12A and 12B show the intermediate shaft locking mechanism 1200 in a first (locked) mode. In the first mode, the intermediate shaft locking mechanism 1200 locks the shafts 1210 together. In some versions, a force from the spring 1250 is used directly or indirectly to lock the shafts 1210 together. As illustrated in Figures 12C and 12D, the slot 1240 may be used to put the intermediate shaft locking mechanism 1200 into a second (unlocked) mode.

[0085]

[0108] Figure 12C shows a cross-sectional view of the intermediate shaft locking mechanism 1200 operating in the first mode. The spring 1250 provides force to the button 1230 and plunger 1231, and the plunger 1231 compresses and / or deforms the grommet 1260. The deformation of the grommet 1260 can provide a force that locks the shafts 1210 together. Note that in the first mode, the button 1230 is not located in the slot 1240.

[0086]

[0109] Figure 12D shows another cross-sectional view of the intermediate shaft locking mechanism 1200. Figure 12D shows a spring 1250 pressing a button 1230 and a plunger 1231, which then presses a grommet 1260. The grommet 1260 may be any material that can deform under pressure (such as an elastomer), such as rubber, silicone, thermoplastic, or any other available material.

[0087]

[0110] Figure 12E shows a perspective view of the intermediate axis locking mechanism 1200 operating in a second (unlocked) mode. In unlocked mode, any axis (not shown) can move freely back and forth within the body 1220. Furthermore, in unlocked mode, the button 1230 and plunger 1231 can be moved away from the grommet 1260.

[0088]

[0111] Figure 12F shows another perspective view of the intermediate axis locking mechanism 1200 operating in a second mode. Button 1230 can be pressed against spring 1250 and moved into slot 1240. In this way, plunger 1231 is held away from grommet 1260, allowing the grommet to recover from deformation and any axis (not shown) to move freely within body 1220.

[0089]

[0112] Figures 13A and 13B show a second intermediate shaft locking mechanism 1300. The intermediate shaft locking mechanism 1300 may include a clamp 1310 and a body 1320. A shaft 1330 can be passed through an opening in the clamp 1310. As the shaft 1330 moves through the clamp 1310, it may bend into an arch shape. The clamp 1310 may include a first tube 1311, a second tube 1312, and a flexible arm 1313 configured to connect the first tube 1311 to the second tube 1312. In some examples, the arm 1313 may hold the first tube 1311 at an angle to the second tube 1312. That is, the arm 1313 may bend the shaft 1330 into an arch shape as it passes between the first tube 1311 and the second tube 1312. The curvature and arch of the shaft 1330 may cause the shaft to interfere with and / or connect with the clamp 1310. In this way, the clamp 1310 can hold the shaft 1330 together. The clamp 1310 may be made of any flexible material, including nylon, or any other elastomer material. The material for the clamp 1310 may allow the arm 1313 to be pushed down, thereby reducing the angle between the first tube 1311 and the second tube 1312. When the angle between the first tube 1311 and the second tube 1312 is reduced, the shaft 1330 can not be held together and can move (slide) freely within the intermediate shaft locking mechanism 1300. The clamp 1310 may include a positioning pin, which moves within a slot located in the body 1320, particularly when the arm 1313 is pushed down.

[0090]

[0113] Figure 13B shows another perspective view of the intermediate shaft locking mechanism 1300. As described with respect to Figure 13A, in order to operate the intermediate shaft locking mechanism 1300 in a second (unlocked) mode, the user may deform the clamp 1310 by pushing the arm 1313 toward the body 1320 to straighten (align) the openings in the first tube 1311 and the second tube 1312 at least partially. In this way, the shaft 1330 may no longer be bent, arched, or coupled with the clamp 1310. Thus, in this mode, the intermediate shaft locking mechanism 1300 can slide to substantially any position on the shaft 1330. Since the first tube 1311 and the second tube 1312 have limited openings, the shaft 1330 must be slid through the clamp 1310 prior to use. Generally, the shaft 1330 is passed through the clamp 1310 during the initial assembly of the associated catheter assembly.

[0091]

[0114] Figures 14A and 14B show a third intermediate shaft locking mechanism 1400. Similar to the intermediate shaft locking mechanism 1300 in Figures 13A and 13B, the intermediate shaft locking mechanism 1400 may include a clamp 1410 and a body 1420. The clamp 1410 may include a first tube 1411, a second tube 1412, and an arm 1413. Similar to the intermediate shaft locking mechanism 1300 in Figures 13A and 13B, the arm 1413 may bend the shaft 1430 into an arch shape as it passes through the first tube 1411 and the second tube 1412. The bending of the shaft 1430 relative to the clamp 1410 may cause the shaft 1430 to be held or locked together.

[0092]

[0115] In some examples, the shaft 1430 may pass through slots in the first tube 1411 and the second tube 1412. Thus, the slots may allow the intermediate shaft locking mechanism 1400 to be easily inserted into or removed from the shaft 1430 (particularly in comparison to the intermediate shaft locking mechanism 1300 in Figures 13A and 13B).

[0093]

[0116] Figure 14B shows another perspective view of the intermediate shaft locking mechanism 1400. As shown, the arm 1413 can be pushed down toward the body 1420 to straighten (align) at least partially the openings in the first tube 1411 and the second tube 1412. The shaft 1430 may no longer be bent, arched, or coupled to the clamp 1410.

[0094]

[0117] Figures 15A to 15C show a fourth intermediate shaft locking mechanism 1500. Figure 15A shows a perspective view of the intermediate shaft locking mechanism 1500, which may include a body 1510 and a cam 1520. The body 1510 may include slots 1511 for receiving two or more shafts 1530.

[0095]

[0118] The cam 1520 can contact the shaft 1530 and tighten it toward the body 1510 in order to secure the shaft 1530 to the body 1510. In some embodiments, the cam 1520 may be designed to rotate only a quarter of a full turn (for example, a quarter turn). Thus, the user can rotate the cam 1520 by a quarter turn to secure or release the shaft 1530 from the body 1510. The first position of the cam 1520 may allow the shaft 1530 to move freely relative to the body 1510. The second position of the cam 1520 may restrain the shaft 1530 relative to the body 1510, thereby locking the shaft 1530 together. Figure 15B shows another perspective view of the intermediate shaft locking mechanism 1500. In this figure, the body 1510, cam 1520, and shaft 1530 are visible, but the slot 1511 is blocked by the body 1510.

[0096]

[0119] Figure 15C shows an exploded assembly view of the intermediate shaft locking mechanism 1500. The intermediate shaft locking mechanism may include a body 1510 and a cam 1520. The cam 1520 may include an elastomer stopper 1521 that can contact the shaft 1530 when the cam 1520 is rotated. The elastomer stopper 1521 protects the shaft 1530 from damage and can also increase the locking force applied by the cam 1520. The elastomer stopper 1521 may be made of rubber, silicone, thermoplastic polyurethane, or other available materials.

[0097]

[0120] Figures 16A and 16B show a fifth intermediate shaft locking mechanism 1600. The intermediate shaft locking mechanism 1600 can lock shafts or catheters together. The intermediate shaft locking mechanism 1600 may include a locking ring 1610 and a locking clip 1620. The locking ring 1610 is shown attached to the first shaft 1630, and the locking clip 1620 is shown attached to the second shaft 1631. In some examples, the locking clip 1620 may be formed from nitinol and welded to the second shaft 1631.

[0098]

[0121] The locking ring 1610 may be formed from any material that can be molded or machined. The locking ring 1610 may include a groove 1611 designed to receive the locking ring 1610. To lock the first shaft 1630 onto the second shaft 1631, a locking clip is snapped into the groove 1611 of the locking ring 1610.

[0099]

[0122] Figure 16B shows the intermediate shaft locking mechanism 1600 when the first shaft 1630 is locked to the second shaft 1631. As shown, the locking clip 1620 is clipped into the groove 1611 of the locking ring 1610.

[0100]

[0123] Figures 17A and 17B show a sixth intermediate shaft locking mechanism 1700. The intermediate shaft locking mechanism 1700 can lock the first shaft 1730 and the second shaft 1731 together. The intermediate shaft locking mechanism 1700 may include a locking ring 1710 and a locking loop 1720. In some modifications, the locking loop 1720 may be formed together with the first shaft 1730. For example, the first shaft 1730 may be formed from nitinol or other similar material.

[0101]

[0124] The locking ring 1710 may be another example of the locking ring 1610 in Figures 16A and 16B. Thus, the locking ring 1710 may include a groove 1711 designed to receive the locking loop 1720.

[0102]

[0125] Figure 17B shows the intermediate shaft locking mechanism 1700 when the first shaft 1730 is locked to the second shaft 1731. As shown, the locking loop 1720 is clipped into the groove 1711 of the locking ring 1710.

[0103]

[0126] Figures 18A and 18B show a seventh intermediate shaft locking mechanism 1800. The intermediate shaft locking mechanism 1800 can lock a first shaft (or catheter) 1830 and a second shaft (or catheter) 1831 together. The intermediate shaft locking mechanism 1800 may include a snap ring 1810 attached to at least one of the shafts. In the exemplary intermediate shaft locking mechanism 1800, the snap ring 1810 is attached to the first shaft 1830, but in other examples, the snap ring 1810 may be attached to any available shaft.

[0104]

[0127] The second shaft 1831 may include a notch 1832 that is bent within the second shaft 1831. The notch 1832 may be configured to snap into a snap ring 1810. In some examples, the snap ring 1810 may be metal or a metallic material such as Nitinol or the like. In other examples, the snap ring 1810 may be an elastomer. The snap ring 1810 may be attached to the first shaft 1830 by welding, adhesive or other available means. Figure 18B shows the intermediate shaft locking mechanism 1800 when the first shaft 1830 is locked onto the second shaft 1831. As shown, the notch 1832 is clipped into the snap ring 1810.

[0105]

[0128] Figures 19A to 19E show the eighth intermediate axis locking mechanism 1900. Figure 19A shows the intermediate axis locking mechanism 1900 open to receive two or more axes 1930. The intermediate axis locking mechanism 1900 can lock the axes (or catheters) 1930 together. The intermediate axis locking mechanism 1900 may include a clamshell body 1910. The clamshell body 1910 may include a first member 1911, a second member 1912, a hinge member 1913, and an elastomer pad 1914.

[0106]

[0129] The first member 1911 can be movably connected to the second member 1912 via the hinge member 1913. The clamshell body 1910 can be molded, including by injection molding. Thus, the hinge member 1913 can have the material properties (flexibility, flexibility, etc.) of the clamshell body 1910.

[0107]

[0130] As shown, the elastomer pad 1914 can be attached to the first member 1911. In other examples, the elastomer pad 1914 can be attached to the second member 1912. The elastomer pad 1914 can lock or restrain the shaft 1930 together by applying pressure and / or friction to the shaft 1930 and the clamshell body 1910. The elastomer pad 1914 may be thermoplastic urethane, silicone, rubber, etc.

[0108]

[0131] Figure 19B shows a perspective view of the intermediate shaft locking mechanism 1900. The first member 1911 includes an elastomer pad 1914, and the second member 1912 includes two or more grooves 1920 for receiving and / or guiding the shaft 1930. In addition, the clamshell body 1910 may include a latching mechanism for latching the first member 1911 to the second member 1912. As shown, the first member 1911 may include an inclined ramp member 1940, and the second member 1912 may include a beam member 1941. The beam member 1941 can interact with the inclined ramp member 1940 to hold the first member 1911 against the second member 1912 so that the elastomer pad 1914 is in contact with the shaft 1930. The inclined ramp member 1940 may be molded on the edge of the first member positioned directly opposite the hinge member 1913. The beam member 1941 may be formed on the edge of a second member 1912 positioned directly opposite the hinge member 1913, in which case the beam member 1941 is configured to engage with and detachably connect to the ramp member 1940.

[0109]

[0132] Figure 19C shows another diagram of the intermediate shaft locking mechanism 1900. The shaft 1930 is located within the second member 1912. In this example, the first member 1911, which includes the elastomer pad 1914, can be closed onto the second member 1912 to lock or restrain the shaft 1930 from each other.

[0110]

[0133] Figure 19D shows the intermediate axis locking mechanism 1900 when the first member 1911 is approaching and beginning to engage with the second member 1912. As shown, the beam member 1941 interacts with the ramp member 1940. In some cases, the ramp member 1940 can deflect or move the beam member 1941.

[0111]

[0134] Figure 19E shows the intermediate shaft locking mechanism 1900 in a locked configuration. The beam member 1941 may contact the locking surface 1942 of the ramp member 1940. In this configuration, the first member 1911 may be held in contact with the second member 1912 by the beam member 1941. Thus, the elastomer pad 1914 may contact the shaft 1930 and lock the shaft 1930 to the second member 1912. To open the intermediate shaft locking mechanism 1900, the user moves the beam member 1941 away from the locking surface 1942.

[0112]

[0135] Figure 20 is a flowchart illustrating an exemplary method 2000 for treating a patient using an IVL system. Several examples may involve performing the actions described herein with additional actions, fewer actions, in different orders, in parallel, or in different ways. Method 2000 is described below with respect to the IVL system 100 of Figure 1, but may be performed with any other suitable system or device.

[0113]

[0136] Method 2000 begins in block 2002 with the insertion of an IVL device into the patient. The IVL device may include a catheter assembly 130 and / or a balloon assembly 140. In some applications, the IVL device is inserted percutaneously into the patient's vein, artery, or other lumen.

[0114]

[0137] Next, in block 2004, the IVL device is advanced into the treatment area. That is, the IVL device is moved to a predetermined position, and in some cases, the position of the IVL device may be verified using available means (e.g., X-ray, sonogram, etc.). In some cases, the radiopaque portions of the catheter assembly 130 and / or balloon assembly 140 may help determine the position of part or all of the IVL system 100. In some examples, the step of advancing the IVL device may include locking two or more catheters or axes together. For example, an outer catheter may be locked together with an inner catheter.

[0115]

[0138] Next, in block 2006, the outer catheter of the catheter assembly 130 may be retracted to expose the balloon assembly 140. The relationship between the outer catheter and the balloon assembly will be described in detail in conjunction with Figures 4 to 9. In some examples, the step of retracting the outer catheter may include unlocking two or more catheters or axes. In some other examples, the step of retracting the outer catheter may include observing or identifying a marker band or ring in an alignment window positioned on the outer catheter.

[0116]

[0139] Next, in block 2008, the balloon contained in the balloon assembly 140 is expanded or inflated, and a shock wave is delivered to the treatment area. For example, a gas or liquid may be introduced into the balloon assembly 140 to expand the balloon. Following the expansion, a high-voltage pulse may be introduced to the electrode to generate a shock wave.

[0117]

[0140] It should be recognized that all combinations of the aforementioned concepts and any additional concepts discussed in more detail below (where such concepts are not contradictory) are intended to be part of the subject matter of the inventions disclosed herein and may be used to obtain the benefits described herein.

[0118]

[0141] The process parameters and sets of steps described and / or illustrated herein are given merely as examples and may be modified as desired. For example, the steps illustrated and / or described herein may be shown or discussed in a particular order, but they do not necessarily have to be performed in the order illustrated or discussed. Various exemplary methods described and / or illustrated herein may omit one or more of the steps described or illustrated herein, or may include additional steps in addition to the disclosed steps.

[0119]

[0142] Where a feature or element is described herein as being "on" another feature or element, such feature or element may be directly on the other feature or element, or there may be intervening features and / or elements. In contrast, where a feature or element is described as being "directly on" another feature or element, there are no intervening features and / or elements. Where a feature or element is described as being "connected," "attached," or "coupled" to another feature or element, it will also be understood that such feature or element may be directly connected, attached, or coupled to the other feature or element, or there may be intervening features or elements. In contrast, where a feature or element is described as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements. Even if described or shown in reference to one embodiment, features and elements described or shown in this way may also apply to other embodiments. It will also be recognized by those skilled in the art that references to structures or features positioned "adjacent" to another feature may have portions that overlap with or lie beneath the adjacent feature.

[0120]

[0143] The terms used herein are for the sole purpose of describing specific embodiments and are not intended to limit the invention. For example, the singular forms “a” (one), “an” (one), and “the” (it) as used herein are intended to include the plural form unless the context explicitly indicates otherwise. It will be further understood that the terms “comprise” and / or “comprising,” as used herein, specify the presence of the described features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. In this specification, terms such as “and / or” include any combination of one or more of the related items described, and may be abbreviated as “ / ”.

[0121]

[0144] Spatially relative terms such as “under,” “below,” “lower,” “over,” and “upper” may be used herein for ease of description to explain the relationship between one element or feature and another, as shown in the diagram. It will be understood that spatially relative terms are intended to encompass various orientations of the device during use or operation, in addition to the orientation shown in the diagram. For example, if the device in the diagram is inverted, an element described as being “under” or “beneath” another element or feature will be oriented “over” the other element or feature. Thus, the exemplary term “under” may encompass both upward and downward orientations. The device may be oriented differently (rotated 90 degrees or in other orientations), and the spatially relative descriptive terms used herein will be interpreted accordingly. Similarly, terms such as “upwardly,” “downwardly,” “vertical,” and “horizontal” are used herein solely for illustrative purposes unless otherwise specifically indicated.

[0122]

[0145] The terms “first” and “second” may be used herein to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another. Thus, without departing from the teachings of the invention, a first feature / element discussed below may be referred to as a second feature / element, and similarly, a second feature / element discussed below may be referred to as a first feature / element.

[0123]

[0146] Throughout this specification and the subsequent claims, unless the context requires otherwise, the term “comprise,” and variations such as “comprises” and “comprising,” mean a variety of components (e.g., configurations and apparatus, including devices and methods) that may be used together in a method and article. For example, the term “comprising” would be understood to imply the inclusion of the element or step described, but not the exclusion of other elements or steps.

[0124]

[0147] Generally, any apparatus or method described herein should be understood as comprehensive; however, all or a subset of its components and / or steps may instead be exclusive, and may be described as "consisting of" or "consisting essentially of" various components, steps, subcomponents, or substeps.

[0125]

[0148] In this specification and in the claims, including the examples, and unless expressly otherwise specified, all numbers may be read as if preceded by the terms “about” or “approximately,” even if not explicitly stated. Expressions such as “about” or “approximately” may be used when describing scale and / or location to indicate that the described value and / or location falls within the expected reasonable range of the value and / or location. For example, a number may have values ​​such as ±0.1% of the stated value (or range of value), ±1% of the stated value (or range of value), ±2% of the stated value (or range of value), ±5% of the stated value (or range of value), ±10% of the stated value (or range of value), and so on. Furthermore, any number described herein should be understood to include about or approximately that value unless the context indicates otherwise. For example, if the value “10” is disclosed, “about 10” is also disclosed. Any numerical range described herein is intended to include all partial ranges encompassed herein. It is understood that, as can be appropriately understood by those skilled in the art, when a value "less than or equal to" is disclosed, "greater than or equal to the value" and possible ranges between values ​​are also disclosed. For example, if a value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (for example, if X is a number) are also disclosed. Throughout this application, it is understood that data is provided in several different forms, and this data also represents endpoints and starting points, as well as ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it is understood that greater than 10 and 15, 10 and 15 or greater, less than 10 and 15, 10 and 15 or less, and equal to 10 and 15 are disclosed as well as between 10 and 15. It is also understood that each unit between two specific units is also disclosed.For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0126]

[0149] While various exemplary embodiments have been described above, any of several modifications may be made to various embodiments without departing from the scope of the invention as described in the claims. For example, the order in which the various method steps described are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be omitted entirely. Optional features of various device and system embodiments may be included in some embodiments but not in others. Therefore, the foregoing description is provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as stated in the claims.

[0127]

[0150] The examples and figures included herein are illustrative, not limiting, of specific embodiments in which the subject matter may be put into practice. As stated, other embodiments may be derived from and utilized therein so that structural and logical substitutions and modifications may be made without departing from the scope of this disclosure. Such embodiments of the subject matter of the present invention may be referred to herein individually or collectively by the term “invention” solely for convenience and without the intention of spontaneously limiting the scope of this application to any single invention or inventive concept if two or more are actually disclosed. Thus, although specific embodiments have been shown and described herein, any configuration estimated to achieve the same objective may be used instead of the specific embodiments shown. This disclosure is intended to encompass all adapted or modified forms of various embodiments. Combinations of the above embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art upon consideration of the above description.

Claims

1. It is an internal catheter, A tapered element connected to the distal end of the aforementioned internal catheter, A balloon assembly located proximal to the tapered element and connected to the inner catheter, the balloon assembly including one or more pairs of electrodes configured to emit an electric arc. Including an internal catheter, It is an external catheter, The inner catheter is coaxially surrounded and configured to be slidably connected to the inner catheter, A tip portion is positioned at the distal end of the lumen and configured to slidably engage with the landing zone of the tapered element. Includes an external catheter and An intravascular lithotripsy device equipped with the necessary components.

2. The intravascular lithotripsy apparatus according to claim 1, wherein the balloon assembly is configured to be inflated by at least one of a liquid or a gas.

3. The intravascular lithotripsy device according to claim 1, wherein the balloon assembly is configured to be housed within the outer catheter when the tip of the outer catheter is in contact with the landing zone of the tapered element.

4. The intravascular lithotripsy apparatus according to claim 1, wherein the outer catheter further comprises an alignment window, and the inner catheter further comprises an intermediate axis marker configured to appear in the alignment window when the tip of the outer catheter is in contact with the landing zone of the tapered element.

5. The intravascular lithotripsy device according to claim 1, further comprising two or more markers configured to indicate the position of the balloon assembly relative to the external catheter when the intravascular lithotripsy device is inserted into a patient.

6. The intravascular lithotripsy device according to claim 5, wherein the two or more markers remain outside the patient's body.

7. The intravascular lithotripsy device according to claim 1, further comprising a control shaft connected to the proximal end of the outer catheter.

8. The intravascular lithotripsy apparatus according to claim 7, comprising a set of first marker bands configured to indicate when the inner catheter is inside the outer catheter.

9. The intravascular lithotripsy apparatus according to claim 7, comprising a set of second marker bands configured to indicate when the balloon assembly extends beyond the outer catheter.

10. A hub connected to the aforementioned internal catheter, A locking clip connected to the control shaft, configured to lock the balloon assembly in a first configuration where the balloon assembly is located outside the outer catheter and a second configuration where the balloon assembly is located inside the outer catheter, and The intravascular lithotripsy apparatus according to claim 7, further comprising:

11. The intravascular lithotripsy apparatus according to claim 1, wherein the two or more electrodes are formed from a flexible circuit, conductive ink, or a combination thereof.

12. The intravascular lithotripsy apparatus according to claim 1, wherein the tapered element has a length of approximately 3 centimeters.

13. The intravascular lithotripsy apparatus according to claim 1, wherein the tip of the outer catheter and the tapered element form a smooth outer surface when the tip of the outer catheter is slidably engaged with the landing zone of the tapered element.

14. The intravascular lithotripsy device according to claim 1, wherein the inner catheter is configured to be withdrawn from the outer catheter.

15. The intravascular lithotripsy device according to claim 1, wherein the balloon assembly has a diameter of 2 to 8 millimeters when inflated.

16. The intravascular lithotripsy apparatus according to claim 1, wherein the balloon assembly has a length of at least 20 millimeters.

17. A step of percutaneously inserting an intravascular lithotripsy device into a patient's blood vessel, wherein the intravascular lithotripsy device includes a balloon assembly connected to an inner catheter and an outer catheter configured to surround the balloon assembly. The steps include advancing the intravascular lithotripsy device into the treatment area, The steps include: retracting the outer catheter to expose the balloon assembly, The steps include: inflating the balloon assembly to deliver a shock wave to the treatment area; Methods that include...

18. The method according to claim 17, wherein the step of advancing the intravascular lithotripsy device includes locking the inner catheter and the outer catheter together.

19. The step of retracting the aforementioned external catheter is Unlocking the inner catheter from the outer catheter, and, Moving the outer catheter distally based on one or more markers placed on the inner catheter and the outer catheter. The method according to claim 17, including the method described in claim 17.

20. The method according to claim 17, wherein the step of retracting the outer catheter includes observing markers with respect to a transparent alignment window positioned on the outer catheter.

21. The method according to claim 17, further comprising the step of deflating the balloon assembly to withdraw the inner catheter from the outer catheter.

22. A locking mechanism for temporarily holding two or more axes together, A cylindrical body configured to receive two or more shafts through a central opening, A flexible grommet configured to collectively restrain the two or more shafts in response to a compressive force, A plunger configured to provide a variable compressive force to the flexible grommet and A locking mechanism equipped with this.

23. The locking mechanism according to claim 22, wherein the flexible grommet is configured to receive the two or more shafts through a central opening concentric with the cylindrical body.

24. The locking mechanism according to claim 22, wherein the plunger includes a button configured to lock the plunger in a position away from the flexible grommet.

25. The locking mechanism according to claim 22, further comprising a spring configured to provide a bias force opposite to the plunger.

26. The locking mechanism according to claim 25, wherein the plunger is configured to provide the compressive force at least partially based on the bias force.

27. The locking mechanism according to claim 22, wherein the cylindrical body comprises a slot configured to hold the plunger away from the flexible grommet.

28. A locking mechanism for temporarily holding two or more axes together, Positioning pin, First guide tube, The second guide tube, and, An arm connecting the first guide tube to the second guide tube, wherein the first guide tube and the second guide tube are configured to accept two or more shafts. Includes clamps and A body flexibly connected to the clamp, including a slot configured to be movably connected to the positioning pin, and A locking mechanism equipped with this.

29. The locking mechanism according to claim 28, wherein the arm is further configured to position the first guide tube at an angle to the second guide tube and to collectively hold the two or more axes.

30. The locking mechanism according to claim 28, wherein the arm is further configured to receive a deflection force, reduce the angle between the first guide tube and the second guide tube, and allow the two or more shafts to slide freely within the first guide tube and the second guide tube.

31. The locking mechanism according to claim 28, wherein the first guide tube and the second guide tube include slots configured to receive the two or more shafts.

32. A locking mechanism for temporarily holding two or more axes together, Cam and, The main body, A slot configured to receive two or more shafts, An opening configured to receive the cam, wherein the cam is configured to contact the two or more shafts and to restrain the two or more shafts relative to the body, and Including the main unit and A locking mechanism equipped with this.

33. The locking mechanism according to claim 32, wherein the cam is configured to rotate by one-quarter of a full rotation in order to secure the two or more shafts to the main body.

34. The locking mechanism according to claim 32, wherein the cam includes an elastomer stopper for contacting the shaft.

35. The locking mechanism according to claim 34, wherein the elastomer stopper is at least one of rubber, thermoplastic urethane, or silicone.

36. The locking mechanism according to claim 32, wherein the cam is configured to allow the shaft to move freely in a first position and to collectively restrain the shaft in a second position.

37. A locking mechanism for temporarily holding two or more axes together, A locking clip connected to the first axis, A locking ring and a groove connected to a second shaft and configured to receive the locking clip A locking mechanism equipped with this.

38. The locking mechanism according to claim 37, wherein the locking clip is laser-welded to the second shaft.

39. The locking mechanism according to claim 37, wherein the locking clip is made of nitinol.

40. The locking mechanism according to claim 37, wherein the locking clip is formed by the second shaft.

41. The locking mechanism according to claim 37, wherein the locking ring is at least one of machined material, welded material, or insert-molded material.

42. The locking mechanism according to claim 37, wherein the second shaft is formed from nitinol.

43. A locking mechanism for temporarily holding two or more axes together, The notch feature formed on the first catheter axis, A snap ring connected to the second catheter axis and configured to accept the notch feature and A locking mechanism equipped with this.

44. The locking mechanism according to claim 43, wherein the first catheter axis is formed from nitinol.

45. A locking mechanism for temporarily holding two or more axes together, First member, The second member, and A hinge member configured to movably connect the first member to the second member. The clamshell body includes, An elastomer pad configured to fit into the first member and to hold the two or more shafts together, A locking mechanism equipped with this.

46. The locking mechanism according to claim 45, wherein the second member includes at least one groove configured to receive at least one shaft.

47. The locking mechanism according to claim 45, wherein the clamshell body is injection molded.

48. The aforementioned clamshell body, An inclined road member formed on the edge of the first member, which is positioned directly opposite the hinge member, A beam member formed on the edge of the second member positioned directly opposite the hinge member, and configured to engage with and detachably connect to the ramp member, and The locking mechanism according to claim 45, comprising a latching portion.

49. The rocking mechanism according to claim 48, wherein the ramp is configured to deflect the beam member when the first member is rotated toward the second member.

50. The rocking mechanism according to claim 48, wherein the beam member is configured to engage with the rocking surface of the ramp member.

51. The locking mechanism according to claim 45, wherein the elastomer pad is at least one of thermoplastic urethane or silicone.

52. An intravascular lithotripsy apparatus according to any one of claims 1 to 6, comprising any one of the locking mechanisms described in claims 22 to 51.

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