Endovascular lithotripsy catheter with laterally movable and positionable emitter

Abstract

A shock wave catheter for performing endovascular lithotripsy (IVL) is provided. The catheter includes an elongation tube having a central longitudinal axis, an inclusion sealed at the distal end of the elongation tube, and an adjustable emitter assembly disposed within the inclusion. The emitter assembly includes, in a first configuration, a shock wave generating emitter that is closer to the central longitudinal axis of the catheter, and in a second configuration, a shock wave generating emitter that is further from the central longitudinal axis than in the first position and is at least one laterally movable or positionable. Various embodiments include support structures for the emitter, multiple balloons for positioning the emitter, spiral ribbons, angled emitter ports, and other exemplary features for moving and / or positioning the emitter. Systems and methods for treating lesions in body luminals are also provided herein.

Description

Technical Field

[0001] (Cross - reference to related applications) This application claims priority to U.S. Provisional Patent Application No. 63 / 534,711, filed Aug. 25, 2023, and U.S. Non - Provisional Patent Application No. 18 / 810,877, filed Aug. 21, 2024, the entire contents of each of which are incorporated herein by reference.

[0002] The present disclosure generally relates to the field of medical devices and methods, and more specifically to shock wave catheter devices for treating lesions within a body lumen.

Background Art

[0003] A variety of catheters have been developed for treating calcified lesions such as intravascular calcified lesions associated with arterial diseases. For example, treatment systems for percutaneous coronary angioplasty or peripheral angioplasty use an angioplasty balloon to dilate the calcified lesion and restore normal blood flow within the blood vessel. In these types of procedures, the catheter carrying the balloon is advanced into the blood vessel along a guide wire until the balloon is aligned with the calcified plaque. The balloon is then pressurized (usually up to above 10 atm) to expand the balloon within the blood vessel, pushing the calcified plaque back into the vessel wall and expanding the occluded region of the blood vessel.

[0004] More recently, intravascular lithotripsy (IVL) techniques and therapies have been developed, which are invasive procedures for modifying calcified plaques within diseased arteries. The mechanism of plaque modification is through the use of a catheter having one or more acoustic shock wave generation sources located within a liquid that can generate acoustic shock waves to modify the calcified plaque. IVL devices vary in design with respect to the energy source used to generate the acoustic shock waves, and two exemplary energy sources are electrohydraulic generation and laser generation.

[0005] Regarding the electrohydraulic generation of acoustic shock waves, a conductive solution (e.g., saline solution) may be contained within an enclosure surrounding the electrode or flushed through a tube surrounding the electrode. Calcification plaque correction is achieved by generating acoustic shock waves within the catheter by a discharge traversing the electrode. This discharge generates one or more rapidly expanding vapor bubbles that produce acoustic shock waves. These shock waves propagate rapidly outward, correcting calcified plaque within the blood vessel. Regarding the laser generation of acoustic shock waves, a laser pulse is transmitted into a fluid within the catheter and thereby absorbed. This absorption process rapidly heats and vaporizes the fluid, thereby generating rapidly expanding vapor bubbles and acoustic shock waves that propagate outward and correct calcified plaque. The intensity of the acoustic shock waves is higher when a fluid exhibiting strong absorption at the employed laser wavelength is selected. These embodiments of IVL devices are not intended to be a comprehensive list of potential energy sources for generating IVL shock waves.

[0006] The IVL process can be considered different from standard atherosclerosis techniques in that it breaks down calcium but does not release the broken-down calcium from the tissue. Therefore, generally speaking, IVL should not require aspiration or embolic protection. Furthermore, due to the responsiveness of normal blood vessels and non-calcified plaque, the shock waves produced by IVL do not correct normal blood vessels or non-calcified plaque.

[0007] More specifically, catheters have been developed for delivering IVL therapy that include a pair of electrodes for electrohydraulically generating shock waves inside an angioplasty balloon. Shock wave devices may be particularly effective for treating calcified plaque lesions because the acoustic pressure from the shock waves can fragment and pulverize lesions near the angioplasty balloon without damaging surrounding tissue. In these devices, the catheter is advanced through the patient's blood vessels over a guidewire until it is positioned proximal to and / or aligned with the calcified lesion in the body lumen. The balloon is then inflated with a fluid (e.g., a conductive fluid such as saline solution in relation to electrohydraulically generated acoustic shock waves), so that the balloon expands (e.g., to a relatively low pressure of 2-4 atm) to contact the lesion, but not to a pressure that substantially displaces the lesion. A voltage pulse is then supplied to the emitter (for example, by applying voltage across one or more electrode pairs of the emitter) to produce an acoustic shock wave that propagates through the wall of the angioplasty balloon into the lesion. Once the lesion is fractured by the acoustic shock wave, the balloon can be further expanded to increase the cross-sectional area of ​​the lumen and improve blood flow through the lumen. Alternative devices for delivering IVL therapy may be within a closed volume other than the angioplasty balloon, such as a cap, a variable-response balloon, or other inclusions.

[0008] However, conventional shock wave catheters may not be very effective for treating lesions in large blood vessels and valves. The catheter should be small enough to maneuver through the vessels to reach the larger blood vessels and valves. Once inside the larger blood vessels and valves, the catheter balloon inflates to a relatively large diameter, which moves the balloon wall further away from the emitter inside the balloon, typically along the central canal that extends along the longitudinal axis of the catheter. Therefore, when shock waves are emitted, they may need to propagate further to reach the lesion in larger blood vessels than in smaller blood vessels, which can reduce the force applied to break up the lesion. To cope with the reduced force output from the emitter inside the large angioplasty balloon, some catheters increase the power supplied to the emitter, producing larger shock waves inside the balloon. However, increasing the magnitude of the shock waves requires increased power and can lead to other problems such as increased wear on the device's emitter and the risk of rupturing the balloon wall with high-voltage shock waves. Other treatment protocols for larger blood vessels and valves may require longer shock wave therapy sessions, which carries a risk of ischemia and other complications during angioplasty procedures. [Overview of the project] [Means for solving the problem]

[0009] Considering the above, there is a need to position the emitter for the IVL device closer to lesions in relatively large blood vessels or other body lumens and chambers (e.g., heart valve chambers). Embodiments of the present disclosure generally achieve such positioning through mechanical and structural techniques. According to one aspect of the present disclosure, a shock wave catheter includes at least one shock wave emitter configured to move laterally with respect to the central longitudinal axis of the catheter, thereby reducing the distance between at least one emitter and a lesion in a body lumen. The emitter may be movably connected to the extension tube of the catheter such that, in a first configuration, the emitter is in a first position, and in a second configuration, the emitter is in a second position further from the central longitudinal axis than the first position. The emitter may be supported by an expandable support structure that can expand laterally to move the emitter further from the central longitudinal axis of the catheter and closer to the lesion. The support structure can then be collapsed to return to a flattened external state, allowing the catheter to be maneuvered through smaller body lumens if required. The emitter can be positioned within one or more laterally expandable inclusions. The inclusions may be configured such that the lumen is not obstructed when the inclusion is laterally expanded (for example, to maintain blood flow during treatment). The emitter can be positioned within one or more balloons of a multi-balloon configuration, which, when inflated, can move the emitter closer to the lesion. The emitter can be positioned within multiple inclusions (e.g., balloons or non-inflatable inclusions) that are movable closer to the lesion using a movable shaft that moves the multiple inclusions into an expansion configuration. Alternatively, the emitter can be positioned on the inner wall of a balloon such that balloon expansion moves the emitter closer to the lesion.

[0010] Reducing the distance between the emitter and the lesion in the body lumen can result in increased force delivery to the lesion during shock wave therapy without the need for longer treatment times or higher power applied to the emitter. Such catheters can facilitate the treatment of larger body lumens, such as large blood vessels and valves, as well as irregular lesions, such as non-concentric and / or nodular calcification lesions. Advantageously, according to one or more embodiments, a single-size expandable catheter may be employed to optimally treat lesions of relatively wide vascular sizes and / or wide vascular occlusion.

[0011] In some embodiments, a catheter is provided for treating lesions in a body lumen, the catheter comprising an extension tube, an inclusion sealed at the distal end of the extension tube, and an emitter assembly disposed within the inclusion. In some embodiments, the emitter assembly comprises at least one emitter configured to generate a shock wave inside the inclusion when power is supplied to at least one emitter. In some embodiments, the catheter further comprises a support structure that supports at least one emitter. In some embodiments, the support structure expands outward with respect to the central longitudinal axis of the extension tube and is configured to move at least one emitter further away from the central longitudinal axis.

[0012] In some embodiments, the support structure includes multiple compartments connected by individual joints.

[0013] In some embodiments, at least one emitter is mounted on a support structure in close proximity to one or more of the joints.

[0014] In some embodiments, at least one emitter includes a first emitter mounted in close proximity to a first joint of the support structure and a second emitter mounted in close proximity to a second joint of the support structure.

[0015] In some embodiments, the joint of the support structure is configured to hinge in alternating directions such that a first emitter moves outward from the longitudinal axis in a first direction, and a second emitter moves outward from the longitudinal axis in a second direction opposite to the first direction.

[0016] In some embodiments, at least one emitter includes a first electrode mounted on a first compartment and a second electrode mounted on a second compartment, such that the spark gap between the electrodes is between a first compartment and a second compartment.

[0017] In some embodiments, one or more of the joints are living hinges.

[0018] In some embodiments, at least one emitter includes a first emitter and a second emitter, and the extension of the support structure moves the first emitter outward from the longitudinal axis in a first direction and the second emitter outward from the longitudinal axis in a second direction lateral to the first direction.

[0019] In some embodiments, at least one emitter further includes a third emitter, and the extension of the support structure moves the third emitter outward from the longitudinal axis in a third direction that is lateral to the first and second directions.

[0020] In some embodiments, at least one emitter includes a first emitter and a second emitter, and the lateral extension of the support structure moves the first emitter and the second emitter along a first plane intersecting the longitudinal axis, so as to move laterally away from the longitudinal axis in opposing directions.

[0021] In some embodiments, at least one emitter includes a first emitter and a second emitter, and the lateral expansion of the support structure moves the first emitter away from the longitudinal axis along a first plane that is coplanar with the longitudinal axis, and moves the second emitter away from the longitudinal axis along a second plane that is coplanar with the longitudinal axis and is transverse to the first plane.

[0022] In some embodiments, the first and second planes are perpendicular to each other.

[0023] In some embodiments, at least one emitter further includes a third emitter, and the expansion of the support structure moves the third emitter away from the longitudinal axis along a third plane that is coplanar with the longitudinal axis and is transverse to the first and second planes.

[0024] In some embodiments, at least one emitter further includes a third emitter and a fourth emitter, and the expansion of the support structure moves the first emitter and the third emitter away from the longitudinal axis in opposite directions along the first plane, and the expansion of the support structure moves the second emitter and the fourth emitter away from the longitudinal axis in opposite directions along the second plane.

[0025] In some embodiments, the emitter assembly further includes an extension member that extends along the longitudinal axis through at least a portion of the expandable support structure.

[0026] In some embodiments, the support structure includes one or more openings, and the extension member extends through one or more of the openings.

[0027] In some embodiments, movement of the extension member in the proximal or distal direction causes expansion of the support structure.

[0028] In some embodiments, the expansion diameter of the support structure is controllable by moving the extension member in the proximal or distal direction.

[0029] In some embodiments, the extension member includes one or more markings that indicate to the user the amount of movement of the extension member associated with one or more expansion diameters of the support structure.

[0030] In some embodiments, the support structure includes a first stop and a second stop that are spaced apart in the collapsed state of the support structure and abut in the expanded state of the support structure.

[0031] In some embodiments, the extension member is operably coupled to at least one of the first stop and the second stop such that movement of the extension member moves the first stop relative to the second stop.

[0032] In some embodiments, the extension member includes a wire, and movement of the wire in the proximal direction causes expansion of the support structure.

[0033] In some embodiments, the extension member includes a first tube and a second tube that surrounds at least a portion of the first tube, and movement of the first tube relative to the second tube causes expansion of the support structure.

[0034] In some embodiments, moving the extension member a predetermined distance reversibly locks the support structure in the expanded state.

[0035] In some embodiments, in the collapsed state, the support structure has a diameter of less than 1 mm.

[0036] In some embodiments, the support structure is expandable to a diameter of at least 5 millimeters (5 mm).

[0037] In some embodiments, the support structure is expandable to a diameter of at least 1 centimeter (1 cm).

[0038] In some embodiments, the inclusion body is an angioplasty balloon.

[0039] In some embodiments, the inclusion body has an expanded diameter of 8 mm to 12 mm.

[0040] In some embodiments, the inclusion body has an expanded diameter greater than 20 millimeters (20 mm).

[0041] In some embodiments, the body lumen is a blood vessel or a valve.

[0042] In some embodiments, the support structure is formed from an elastic material selected from the group including metals or polymer materials.

[0043] In some embodiments, after expansion of the support structure, the structure can return to substantially the same configuration in the compressed state.

[0044] In some embodiments, the material properties of the support structure bias the support structure into a crushed state.

[0045] In some embodiments, the material properties of the support structure bias the support structure into an expanded state.

[0046] In some embodiments, the catheter further includes one or more springs connected to the proximal or distal end of the support structure.

[0047] In some embodiments, one or more springs are configured to bias the support structure into a compressed state.

[0048] In some embodiments, one or more springs are configured to bias the support structure into an extended state.

[0049] In some embodiments, the emitter assembly further comprises a first wire and a second wire, the first and second wires extending along at least a portion of the extension tube and configured to apply a voltage to one or more of the at least one emitters such that a current is transmitted across at least one electrode pair of at least one emitter.

[0050] In some embodiments, at least a portion of the support structure is conductive and configured to provide a voltage to at least one emitter.

[0051] In some embodiments, at least one emitter is oriented to generate shock waves outward from the longitudinal axis.

[0052] In some embodiments, the support structure comprises a flexible ribbon, in a first configuration the ribbon is substantially unwound, and in a second configuration the ribbon is wound in a spiral shape, with at least one emitter located at least 1 mm away from the central longitudinal axis of the encapsulation.

[0053] In some embodiments, in the second configuration, at least one emitter is located approximately 3 mm to 6 mm away from the central longitudinal axis of the inclusion.

[0054] In some embodiments, in the second configuration, at least one emitter is less than 1 mm away from the wall of the inclusion.

[0055] In some embodiments, the inclusion body is an angioplasty balloon, and in a second configuration, the balloon is filled to a pressure of approximately 1 atm to approximately 6 atm.

[0056] In some embodiments, the ribbon is configured to be in a first configuration when the inclusion is not expanded, and to automatically change to a second configuration when the inclusion expands.

[0057] In some embodiments, the support structure is connected to a rotatable proximal handle, and rotation of the proximal handle changes the ribbon from a first configuration to a second configuration.

[0058] In some embodiments, a catheter is provided for treating lesions in body tubules, the catheter comprising an extension tube, at least one emitter configured to generate shock waves when power is supplied to at least one emitter, a first encapsulation body surrounding a first emitter of at least one emitter and being fillable with fluid, and a second encapsulation body being fillable with fluid to expand the second encapsulation body. In some embodiments, expansion of the second encapsulation body while the catheter is positioned in a body tubule moves at least one emitter closer to the lesion in the body tubule.

[0059] In some embodiments, the first and second encapsulants can be independently filled using a fluid.

[0060] In some embodiments, the extension tube includes a first channel for introducing fluid into a first encapsulation body and a second channel for introducing fluid into a second encapsulation body.

[0061] In some embodiments, the first inclusion is sealed to the extension tube at one end.

[0062] In some embodiments, the first emitter is mounted on an extension tube inside the first enclosure.

[0063] In some embodiments, the first emitter is located on the inner surface of the first inclusion.

[0064] In some embodiments, the second encapsulation surrounds the second emitter of at least one emitter.

[0065] In some embodiments, the catheter includes a second extension tube, and a second inclusion is sealed in a region of the second extension tube.

[0066] In some embodiments, the second extension tube includes a fluid lumen for introducing fluid into the second encasing.

[0067] In some embodiments, the second emitter is mounted on a second extension tube.

[0068] In some embodiments, the catheter further includes a third encapsulation body, the third encapsulation body surrounding the third emitter of at least one emitter.

[0069] In some embodiments, the second inclusion is a central inclusion, and the first and third inclusions are positioned adjacent to and around the central inclusion when the catheter is placed in a body lumen.

[0070] In some embodiments, the first emitter of the first encapsulation and the third emitter of the third encapsulation are configured to selectively generate shock waves.

[0071] In some embodiments, the central encapsulation does not surround the emitter.

[0072] In some embodiments, the fluid is a conductive fluid.

[0073] In some embodiments, a catheter is provided for treating lesions in a body lumen, the catheter comprising an extension tube, an insulator sealed in the extension tube and fillable with fluid, and at least one emitter positioned on the inner surface of the insulator and configured to generate shock waves inside the insulator when power is supplied to at least one emitter. In some embodiments, the expansion of the insulator while the catheter is positioned in a body lumen causes at least one emitter to move closer to the wall of the body lumen.

[0074] In some embodiments, at least one emitter is attached to the inner surface of the balloon by adhesive bonding.

[0075] In some embodiments, at least one emitter includes multiple emitters.

[0076] In some embodiments, multiple emitters are arranged on the inner surface of the balloon in a spiral pattern or grid pattern.

[0077] In some embodiments, at least one emitter is oriented to generate shock waves outward from the longitudinal axis of the catheter.

[0078] In some embodiments, each emitter includes a pair of electrodes that form a spark gap between the electrodes, the spark gap being at least one-tenth of a millimeter (0.1 mm) away from the inner surface of the encapsulation.

[0079] In some embodiments, at least one emitter includes a spacer, each configured to maintain a spark gap so as to be at least one-tenth of a millimeter (0.1 mm) away from the inner surface of the encapsulation.

[0080] In some embodiments, the catheter further includes a first wire and a second wire, the first and second wires extending along at least a portion of the extension tube and configured to supply power to one or more of at least one emitter.

[0081] In some embodiments, the fluid is a conductive fluid.

[0082] In some embodiments, a system is provided for treating lesions in body tubules, the system comprising a catheter and a power supply configured to power at least one emitter and generate shock waves for treating the lesion.

[0083] In some embodiments, a method is provided for treating a lesion in a body lumen, the method comprising advancing a catheter to a position close to the lesion within the body lumen. In some embodiments, the method comprises inflating the catheter's encapsulation so that the outer surface of the encapsulation contacts the body lumen. In some embodiments, the method comprises expanding a support structure inside the encapsulation to position at least one emitter positioned on the support structure closer to the lesion in the body lumen. In some embodiments, the method comprises supplying power to at least one emitter to generate one or more shock waves inside the encapsulation to treat the lesion.

[0084] In some embodiments, extending the support structure moves the first emitter outward from the longitudinal axis of the catheter in a first direction and the second emitter outward from the longitudinal axis in a second direction.

[0085] In some embodiments, the first direction is opposite to the second direction.

[0086] In some embodiments, the support structure includes a first stop and a second stop, which are spaced apart in the compressed state of the support structure and come into contact in the expanded state of the support structure, and expanding the support structure includes moving the second stop toward the first stop.

[0087] In some embodiments, extending the support structure involves moving an extension member in a proximal or distal direction, the extension member extending between a first stop and a second stop and operably coupled to at least one of them.

[0088] In some embodiments, the extension member includes a first tube and a second tube surrounding at least a portion of the first tube, and the movement of the second tube relative to the first tube causes expansion of the support structure.

[0089] In some embodiments, extending the support structure involves pulling a wire that is operably coupled to at least one of a first stop and a second stop.

[0090] In some embodiments, the method further includes rotating the support structure to position at least one emitter closer to the lesion within the body lumen.

[0091] In some embodiments, the encapsulant is folded when the catheter is advanced through the body lumen.

[0092] In some embodiments, the diameter of the support structure is less than 1 mm when the catheter is advanced through the body lumen.

[0093] In some embodiments, expanding the support structure includes expanding the support structure to a diameter of 8 mm to 12 mm.

[0094] In some embodiments, expanding the support structure includes expanding the support structure to a diameter greater than 1 centimeter (1 cm).

[0095] In some embodiments, the catheter further includes supplying power to one or more emitters, generating one or more shock waves, and then further expanding the support structure.

[0096] In some embodiments, a method is provided for treating a lesion in a body lumen, the method comprising advancing a catheter to a position close to the lesion within the body lumen. In some embodiments, the method comprises inflating a first inclusion of the catheter, the first inclusion surrounding a first emitter. In some embodiments, the method comprises inflating a second inclusion of the catheter, the inflation of the second inclusion while the catheter is positioned in the body lumen moves the first emitter closer to the lesion within the body lumen. In some embodiments, the method comprises supplying power to the first emitter to generate one or more shock waves inside the first inclusion to treat the lesion.

[0097] In some embodiments, the second encapsulation surrounds the second emitter, and the method further includes supplying power to the second emitter and generating one or more shock waves inside the second encapsulation.

[0098] In some embodiments, inflating the first and second inclusions involves filling the inclusions with a conductive fluid.

[0099] In some embodiments, inflating the first inclusion includes filling the first inclusion with a conductive fluid through a first fluid lumen, and inflating the second inclusion includes filling the second inclusion with a conductive fluid through a second fluid lumen.

[0100] In some embodiments, the first and second encapsulants are folded when the catheter is advanced through the body lumen.

[0101] In some embodiments, the method further includes rotating the first and second inclusions around the longitudinal axis of the catheter to move the first emitter closer to the occlusion within the body lumen.

[0102] In some embodiments, the method further includes inflating a third inclusion of the catheter, and inflating the third inclusion while the catheter is positioned in a body lumen moves the first emitter closer to the lesion in the body lumen.

[0103] In some embodiments, the third encapsulation surrounds the third emitter, and the method further includes supplying power to the third emitter and generating one or more shock waves inside the third encapsulation.

[0104] In some embodiments, a method is provided for treating a lesion in a body lumen, the method comprising advancing a catheter to a position close to the lesion within the body lumen. In some embodiments, the method comprises inflating a catheter enclosure so that a plurality of emitters, positioned on the inner surface of the enclosure, move closer to the lesion in the body lumen. In some embodiments, the method comprises supplying power to the plurality of emitters to generate one or more shock waves to treat the lesion.

[0105] In some embodiments, a shock wave catheter is provided, comprising an extension tube having a central longitudinal axis, an encasing sealed at the distal end of the extension tube, and an adjustable emitter assembly disposed within the encasing. In some embodiments, the emitter assembly includes at least one shock wave generating emitter movably connected to the extension tube, such that in a first configuration, at least one emitter is in a first position, and in a second configuration, at least one emitter is in a second position, which is more than 3 mm further from the central longitudinal axis than the first position.

[0106] In some embodiments, a shock wave catheter is provided, comprising an extension tube having an emitter port and defining a central longitudinal axis; an insulator sealed at the distal end of the extension tube; and a shock wave generating emitter positioned along an emitter axis not parallel to the central longitudinal axis. In some embodiments, the emitter axis extends from the central longitudinal axis through the emitter port.

[0107] In some embodiments, in a first configuration, the shock wave generating emitter is located inside the emitter port, and in a second configuration, the shock wave generating emitter is located at least half a millimeter (0.5 mm) outside the emitter port.

[0108] In some embodiments, the catheter further includes a second shock wave generating emitter located along a second emitter axis not parallel to the central longitudinal axis, the extension tube having a second emitter port, and the second emitter axis extending through the second emitter port.

[0109] In some embodiments, a method is provided for treating a lesion in a body lumen, the method comprising advancing a catheter having a distal end and a proximal end in a body lumen to a position close to the lesion, such that a first shock wave emitter of the catheter is located distal to the lesion and a second shock wave emitter of the catheter is located proximal to the lesion. In some embodiments, the method further comprises inflating the catheter's encasing using a fluid, the encasing surrounding the first and second shock wave emitters. In some embodiments, the method further comprises moving the first and second shock wave emitters laterally away from the catheter's extension tube. In some embodiments, the method further comprises supplying power to the first and second shock wave emitters, generating at least one shock wave from each of the first and second shock wave emitters, and treating the lesion.

[0110] In some embodiments, the first and second shock wave generating emitters are powered such that shock waves are generated substantially simultaneously from the first and second emitters.

[0111] In some embodiments, the first and second shock wave generating emitters each comprise a pair of electrodes, and supplying power to the emitters involves applying a voltage across each pair of electrodes.

[0112] In some embodiments, a method is provided for treating a lesion in a body lumen, the method comprising advancing a catheter in a body lumen to a position close to the lesion. In some embodiments, the catheter includes an extension tube, an inclusion sealed at the distal end of the extension tube, and a shock wave generating emitter assembly disposed within the inclusion. In some embodiments, the emitter assembly includes a first emitter, a second emitter circumferentially aligned with the first emitter, a third emitter axially aligned with the first emitter and circumferentially offset from the second emitter, a fourth emitter circumferentially aligned with the third emitter and axially aligned with the second emitter, and a support structure supporting the first, second, third, and fourth emitters. In some embodiments, the support structure is configured to expand laterally with respect to the central longitudinal axis of the extension tube, moving the first, second, third, and fourth emitters further away from the central longitudinal axis. In some embodiments, the method further includes inflating the catheter's containment using a fluid, which surrounds the first, second, third, and fourth shock wave generating emitters. In some embodiments, the method further includes moving the first, second, third, and fourth emitters laterally away from the extension tube. In some embodiments, the method further includes supplying power to the emitter assembly to generate one or more shock waves from at least one of the first, second, third, and fourth shock wave generating emitters.

[0113] In some embodiments, the method further includes positioning the catheter such that the first emitter is located distal to the lesion and the second emitter is located proximal to the lesion, and powering the emitter assembly includes powering the first and second emitters.

[0114] In some embodiments, moving the first and second emitters laterally away from the extension tube moves the first and second emitters closer to each other.

[0115] In some embodiments, a shock wave catheter is provided, comprising an extension tube, a sealing body sealed in the extension tube and fillable with fluid through the lumen of the extension tube, and a flexible ribbon including at least one emitter configured to generate shock waves when powered. In some embodiments, in a first configuration, the ribbon is substantially unwound, and in a second configuration, the ribbon is wound in a spiral shape, with at least one emitter located at least 1 mm from the central longitudinal axis of the balloon.

[0116] In some embodiments, in the second configuration, at least one emitter is located approximately 3 to 6 millimeters (3 mm to 6 mm) away from the central longitudinal axis of the balloon.

[0117] In some embodiments, in the second configuration, at least one emitter is less than 1 mm away from the wall of the inclusion.

[0118] In some embodiments, the inclusion body is an angioplasty balloon, and in a second configuration, the balloon is filled to a pressure of approximately 2 atmospheres (2 atm) to approximately 6 atmospheres (6 atm).

[0119] According to one aspect, an exemplary catheter for treating lesions in body lumens comprises a catheter body having multiple lumens, a distal tip, a movable shaft extending from the proximal portion of the catheter to the distal tip and movable longitudinally within a first lumen of the multiple lumens of the proximal shaft, and a laterally expandable structure comprising at least one emitter support fixedly positioned within a second lumen of the multiple lumens of the proximal shaft and extending to the distal tip, wherein the at least one emitter support comprises an outer extension member, an inner extension member, and a shock wave emitter assembly positioned on the inner extension member, wherein in a lateral collapse configuration of the expandable structure, the movable shaft is in a proximal position, and in a lateral expansion configuration of the expandable structure, the movable shaft is in a distal position, and in the lateral expansion configuration, the catheter is configured to allow the passage of fluid around the lateral expansion structure.

[0120] In some embodiments, in a lateral expansion configuration, the catheter has an expanded maximum width w, and the catheter has an expanded occupied area FP, where FP = π(w / 2). 2 Therefore, the distal end of the catheter body has a cross-sectional area of ​​less than 50% of the FP in the laterally expandable structure.

[0121] In some embodiments, the laterally expandable structure includes a plurality of emitter supports that are laterally expandable.

[0122] In some embodiments, each of the multiple emitter supports comprises an emitter assembly, and each emitter assembly is separately connected to an energy source.

[0123] In some embodiments, each of the multiple emitter supports is fluidly connected to a fluid source.

[0124] In some embodiments, each of the multiple emitter supports extends proximal through the individual lumens of multiple lumens of the proximal shaft.

[0125] In some embodiments, multiple emitter supports extend proximal together within a single lumen of the catheter body.

[0126] In some embodiments, the laterally expandable structure includes three emitter supports.

[0127] In some embodiments, the emitter support comprises multiple hinges.

[0128] In some embodiments, the emitter support includes a shape memory material.

[0129] In some embodiments, in the extended configuration, the emitter support is in contact with the wall of the body lumen.

[0130] In some embodiments, the emitter assembly includes at least one shock wave emitter having at least one electrode pair.

[0131] In some embodiments, the catheter body includes a guidewire lumen.

[0132] In some embodiments, the emitter assembly is located further from the central longitudinal axis of the catheter in a lateral expansion configuration than in a lateral collapse configuration.

[0133] In some embodiments, the emitter support comprises a proximal region extending from the proximal shaft, a distal region extending to the distal tip, a central region located between the proximal and distal regions, and a transitional region between the central region and the proximal and distal regions, wherein the central region is parallel to the central longitudinal axis of the catheter in both the lateral collapse configuration and the lateral expansion configuration.

[0134] In some embodiments, the emitter support further comprises bent regions at the proximal and distal ends of each transition region.

[0135] In some embodiments, the bending region includes an outer extension member that is thinner than the central region.

[0136] In some embodiments, the movable shaft is slidable longitudinally with respect to the emitter support.

[0137] In some embodiments, the proximal shaft has a proximal outer diameter, and the expandable structure has a maximum width less than or equal to the proximal outer diameter in the collapse configuration.

[0138] In some embodiments, the distal tip has a distal outer diameter, and the expandable structure has a maximum width less than or equal to the proximal outer diameter in the collapse configuration.

[0139] According to one aspect, an exemplary method for treating a lesion in a body lumen comprises advancing an IVL catheter having a laterally expandable structure including a shock wave emitter assembly through a body lumen, wherein the laterally expandable structure is in a lateral collapse configuration, positioning the emitter assembly adjacent to the lesion, moving the emitter assembly closer to the lesion by laterally expanding the laterally expandable structure, introducing a solution into the emitter assembly through the fluid lumen of the laterally expandable structure, supplying energy to the emitter assembly from an energy source connected to the emitter assembly by an energy guide to generate one or more shock waves, and laterally compressing the expandable structure, wherein the catheter comprises a movable shaft and a catheter body having a plurality of lumens, the movable shaft being in a more proximal position in the first lumen of the plurality of lumens than in the lateral expansion configuration.

[0140] In some embodiments, extending a laterally expandable structure laterally includes moving a movable shaft connected to the expandable structure from a distal position to a proximal position.

[0141] In some embodiments, laterally expanding a laterally expandable structure creates at least one gap for blood to flow beyond the laterally expandable structure within a body lumen.

[0142] In some embodiments, introducing a solution involves creating a vacuum over the fluid lumen at the proximal end of the fluid lumen, replacing the fluid source with the vacuum, and filling the laterally expandable structure with the solution.

[0143] In some embodiments, introducing a solution fills a laterally expandable inclusion, which is configured not to expand when filled with the solution.

[0144] According to one aspect, an exemplary method for treating a lesion in a body lumen includes advancing an IVL catheter having a laterally expandable structure including a shock wave emitter assembly through a body lumen, wherein the laterally expandable structure is in a laterally compressible configuration, positioning the emitter assembly adjacent to the lesion, moving the emitter assembly closer to the lesion by laterally expanding the laterally expandable structure so that the outer extension member of the laterally expandable structure contacts the lesion, introducing a solution into the emitter assembly through the fluid lumen of the laterally expandable structure, supplying energy to the emitter assembly from an energy source connected to the emitter assembly by an energy guide to generate one or more shock waves, and laterally compressing the expandable structure.

[0145] In some embodiments, the outer extension member includes a fluid lumen.

[0146] In some embodiments, the outer extension member is configured not to expand when it is filled with a solution.

[0147] In some embodiments, laterally expanding the laterally expandable structure so that its outer extension member contacts the lesion allows blood to flow beyond the laterally expandable structure within the lumen. [Brief explanation of the drawing]

[0148] The illustrative aspects of this disclosure are described in detail below with reference to the following figures. The embodiments and figures disclosed herein are intended to be illustrative, not restrictive.

[0149] [Figure 1] Figure 1 illustrates an exemplary system comprising a shock wave catheter and a power supply, depicting a catheter for treating stenosis in a blood body lumen according to one or more aspects of the present disclosure.

[0150] [Figure 2]Figures 2A and 2B illustrate the distal end of an exemplary shock wave catheter equipped with a first expandable support structure, according to one or more aspects of the present disclosure. Figure 2A illustrates the expandable support structure in a collapsed state. Figure 2B illustrates the expandable support structure in an expanded state.

[0151] [Figure 3] Figures 3A and 3B illustrate the distal end of an exemplary shock wave catheter, comprising a second expandable support structure, as shown in one or more aspects of the present disclosure. Figure 3A illustrates the expandable support structure in a collapsed state. Figure 3B illustrates the expandable support structure in an expanded state.

[0152] [Figure 4] Figures 4A–4C illustrate cross-sectional views of the distal end of an exemplary shock wave catheter, including an expandable support structure, from one or more aspects of the present disclosure. Figure 4A illustrates an expandable support structure including at least two emitters configured to move outward from the longitudinal axis of the catheter in opposing directions. Figure 4B illustrates an expandable support structure including at least three emitters configured to move outward from the longitudinal axis of the catheter in three transverse directions. Figure 4C illustrates an expandable support structure including at least four emitters configured to move outward from the longitudinal axis in at least two planes intersecting the longitudinal axis.

[0153] [Figure 5]Figures 5A–5C illustrate the distal end of an exemplary shock wave catheter, including a first stop and a second stop, according to one or more aspects of the present disclosure. Figure 5A illustrates the first stop, positioned away from the second stop (for example, when the expandable support structure of the catheter is in a collapsed state for catheter insertion and / or advancement). Figure 5B illustrates the first stop, in contact with the second stop (for example, when the expandable support structure of the catheter is in an expanded state). Figure 5C illustrates the second stop, positioned away from the first stop (for example, when the expandable support structure of the catheter is in a collapsed state for catheter removal).

[0154] [Figure 6] Figures 6A–6C illustrate cross-sectional views of the distal end of various exemplary shock wave catheters, including two or more inclusions, from one or more aspects of the present disclosure. Figure 6A illustrates an arrangement of a first and second inclusion. Figure 6B illustrates a four-balloon arrangement having a first balloon, a second balloon, a third balloon, and a fourth balloon (two of the balloons are visible in the figure). Figure 6C illustrates an arrangement having a central balloon and a plurality of peripheral balloons.

[0155] [Figure 7] Figures 7A–7C illustrate cross-sectional views of the distal end of various exemplary shock wave catheters, including two or more inclusions, from one or more aspects of the present disclosure. Figure 7A illustrates an arrangement of a first and second inclusion. Figure 7B illustrates a four-balloon arrangement having a first balloon, a second balloon, a third balloon, and a fourth balloon (two of the balloons are visible in the figure). Figure 7C illustrates an arrangement having a central balloon and a plurality of peripheral balloons.

[0156] [Figure 8] Figure 8 illustrates the distal end of an exemplary shock wave catheter, including at least one emitter positioned on the inner surface of an inclusion, according to one or more aspects of the present disclosure.

[0157] [Figure 9] Figure 9 illustrates a cross-sectional view of an exemplary catheter extension tube from one or more aspects of the present disclosure.

[0158] [Figure 10] Figure 10 illustrates a flowchart of an exemplary method for treating intraluminal lesions in a body lumen using a shock wave catheter having an expandable support structure, according to one or more aspects of the present disclosure.

[0159] [Figure 11] Figure 11 illustrates a flowchart of an exemplary method for treating intraluminal lesions in a body lumen using a shock wave catheter having two or more inclusions, according to one or more aspects of the present disclosure.

[0160] [Figure 12] Figure 12 illustrates a flowchart of an exemplary method for treating a lesion in a body lumen using a shock wave catheter having at least one emitter positioned on the inner surface of an inclusion body, according to one or more aspects of the present disclosure.

[0161] [Figure 13] Figure 13 illustrates a flowchart of an exemplary method using a shock wave catheter.

[0162] [Figure 14] Figures 14A and 14B illustrate exemplary shock wave catheters having a flexible ribbon at their distal end. Figure 14A illustrates a first configuration of the catheter in which the ribbon is substantially linear (e.g., substantially unwound). Figure 14B illustrates a second embodiment of the catheter in which the ribbon is spirally wound and substantially centered on the central longitudinal axis of the inclusion body.

[0163] [Figure 15]Figures 15A–15D illustrate the distal region of another exemplary shock wave catheter having one or more movable shock wave emission regions, such as an angled port for housing an emitter. Figures 15A and 15B illustrate the shock wave generating region, at least partially housed within the angled port. Figures 15C and 15D illustrate the shock wave generating region, which is moved outward from the angled port so that it is further away from the central axis of the catheter.

[0164] [Figure 16] Figure 16 illustrates a flowchart of an exemplary method for treating an occlusion using a shock wave catheter having an outwardly movable shock wave generating region.

[0165] [Figure 17] Figure 17 illustrates a flowchart of another exemplary method for treating an occlusion using a shock wave catheter having an outwardly movable shock wave generating region.

[0166] [Figure 18A] Figure 18A illustrates exemplary shock wave catheters having a laterally expandable structure in an expanded configuration, according to several embodiments.

[0167] [Figure 18B] Figure 18B illustrates the exemplary shock wave catheter of Figure 18A in a collapse configuration according to several embodiments.

[0168] [Figure 19] Figure 19 shows front cross-sectional views of the catheter in Figures 18A-18B in an extended configuration according to several embodiments.

[0169] [Figure 20] Figure 20 illustrates detailed diagrams of exemplary shock wave emitter assemblies in several embodiments.

[0170] [Figure 21]Figure 21 illustrates a flowchart of an exemplary method for using a shock wave catheter having a laterally expandable structure.

[0171] [Figure 22] Figure 22 illustrates a flowchart of another exemplary method for using a shock wave catheter having a laterally expandable structure. [Modes for carrying out the invention]

[0172] Detailed explanation The following descriptions are provided to enable those skilled in the art to construct and use the various embodiments and aspects disclosed herein. Descriptions of specific catheters, systems, methods, and applications are provided only as examples. Various modifications to the embodiments described herein will be readily apparent to those skilled in the art, and the general principles described herein may be applied to other embodiments and applications without departing from the spirit and scope of the various embodiments and aspects. Accordingly, the various embodiments and aspects are not intended to be limited to the embodiments described and shown herein, but are given a scope consistent with the claims.

[0173] Described herein is a shock wave catheter incorporating at least one emitter inside an inclusion at the distal end of the catheter, such as an inflatable angioplasty balloon or a non-inflatable cap. The at least one emitter is moved outward from the central longitudinal axis of the catheter, allowing the emitter to be positioned further from the central longitudinal axis of the catheter and closer to the inclusion wall, and therefore closer to the body lumen containing the lesion to be targeted for treatment by the catheter. As used herein, the terms “outward,” “radial,” or “lateral” refer to a direction that is transverse to the central longitudinal axis of the catheter (e.g., including a component that is normal). Therefore, moving the emitter "outward," "radially," or "laterally" from the central longitudinal axis of the catheter indicates that the emitter is moving from a first position closer to the longitudinal axis in a direction normal to the central longitudinal axis to a second position further from the longitudinal axis (and / or closer to the lesion in the body lumen).

[0174] Advantageously, these catheters can be inserted and advanced through body lumens in a relatively thinner external form, and the emitter can be moved outward after the catheter is positioned within the body lumen requiring treatment. Therefore, outward movement of the emitter in situ does not prevent the catheter from being inserted into a relatively smaller area of ​​the body lumen, advancing through it, and treating it. When the catheter is positioned within a body lumen such as a blood vessel or valve, moving the emitter closer to the lesion within the body lumen reduces the distance the shock wave needs to travel between the emitter and the lesion compared to shock waves emitted from a more central location within the inclusion body, thereby resulting in less reduction of the force of the shock wave when they reach the lesion, improving the speed and efficacy of treatment with shock wave catheters. Such catheters may be particularly useful for treating large body lumens such as large blood vessels and valves in blood vessels, as well as eccentric and nodular calcium and other irregular lesions within body lumens.

[0175] The emitter can be moved closer to the body lumen in several ways. For example, in some embodiments, the emitter is movably connected to an extension tube so that the emitter can be moved from a first configuration to a second configuration and positioned further away from the central longitudinal axis of the catheter. In some embodiments, the emitter is positioned on a laterally expandable support structure within the inclusion body, which expands outward from the longitudinal axis of the catheter within the inclusion body, allowing one or more of the emitters mounted on the support structure to be positioned closer to the body lumen. In another embodiment, the catheter includes a plurality of adjacent inclusion bodies, at least one of which is inflatable, and at least one of which includes at least one emitter. Inflation of one or more of the inflatable inclusion bodies moves at least one emitter closer to the wall of the body lumen. In some embodiments, the plurality of inclusion bodies are not inflatable or are minimally inflatable to reduce the amount of blood flow obstruction. In further embodiments, the catheter includes an inclusion body having at least one emitter positioned on the inner surface of the inclusion body such that the expansion of the inclusion body within the body lumen causes the emitter to move away from the longitudinal axis of the catheter and toward the body lumen.

[0176] As used herein, the term “electrode” refers to a conductive element (typically made of metal) that receives an electric current and subsequently discharges it to another conductive element. In the context of this disclosure, electrodes are often positioned relative to each other, such as in an inner and outer electrode arrangement. Thus, as used herein, the term “electrode pair” refers to two electrodes positioned adjacent to each other such that the application of a sufficiently high voltage to the electrode pair will cause an electric current to be transmitted across the gap between the two electrodes (also called the “spark gap”) (for example, from the inner electrode to the outer electrode, or vice versa, and optionally, the electricity passes through a conductive fluid or gas between them). In some contexts, one or more electrode pairs may also be referred to as an electrode assembly. In the context of this disclosure, the term “emitter” broadly refers to the region of the electrode assembly through which the electric current is transmitted, generating a shock wave. Emitters can be singular, paired, or arranged together in different ways. During shock wave therapy, shock waves can be generated in all emitters or in only a specific subset of emitters. Emitters can be wired in series to generate shock waves together. Emitters can be on separate circuits or separate circuit branches and operate independently. The term “emitter sheath” refers to a sheath of conductive material that can form one or more electrodes of one or more electrode pairs, thereby forming the location of one or more emitters. One or more of the emitters, emitter sheaths, emitter assemblies, and / or electrodes may be formed from metals such as stainless steel, copper, tungsten, platinum, palladium, molybdenum, cobalt, chromium, iridium, or alloys or multiple alloys thereof such as cobalt-chromium, platinum-chromium, cobalt-chromium-platinum-palladium-iridium, or platinum-iridium, or mixtures of such materials.

[0177] As used herein, the term “shock wave generating region” refers to a structure on a catheter capable of generating shock waves. For example, a shock wave generating region may encompass an emitter or emitter sheath. In an electrohydraulic IVL catheter, the shock wave generating region may include one or more electrode pairs that emit shock waves in response to current being transmitted across a spark gap. In other embodiments, a high-energy laser is used to generate shock waves by pulsing laser light inside an enclosure. In such embodiments, the catheter may include one or more optical fibers, the output end of which is the shock wave generating region. Other types of shock wave sources, such as piezoelectric and / or electromagnetic-based sources, are also possible. For example, a shock wave generating region may include a piezoelectric transducer.

[0178] It should be understood that any disclosure of numerical ranges describing dimensions or measurements such as thickness, length, weight, time, frequency, temperature, voltage, current, and angle, as provided herein, encompasses any numerical increment or gradient within the range described for a given dimension or measurement. Furthermore, numerical specifiers such as “first,” “second,” “third,” and “fourth” are merely descriptive and do not indicate the relative order, location, or identification of the elements or features described by the specifier. For example, a “first” shock wave may be immediately followed by a “third” shock wave, and then a “second” shock wave. In another embodiment, a “third” emitter may be used to generate a “first” shock wave, and vice versa. Thus, the numerical specifiers for various elements and features are not intended to limit this disclosure and may be modified and replaced.

[0179] Figure 1 depicts an exemplary system 10, comprising a shock wave catheter 100, according to one or more embodiments. The shock wave catheter 100 comprises an extension tube 12 and at least one inclusion body (e.g., an inflatable angioplasty balloon or a non-inflatable cap) that encloses one or more shock wave emitters (not shown) that emit shock waves inside the inclusion body for treating lesions in body lumens, such as stenotic lesions as depicted in Figure 1. In various embodiments, the lesion may be a calcified area of ​​a vascular, a thrombus or occlusion in a vascular, an arteriosclerotic plaque, or other lesions in body lumens, such as kidney stones in the ureter.

[0180] The extension tube 12 generally extends along the central longitudinal axis of the catheter 100 between the handle 22 of the catheter 100 at its proximal end and the distal end 14 of the catheter. As will be described in more detail below, the distal end 14 includes a shock wave emitter and an inclusion and is configured to be inserted into a patient's body lumen, such as a blood vessel, valve, ureter, or some other body lumen. The extension tube 12 may include various lumens and / or channels that are sized to carry fluid, conductive wires, and other aspects of the catheter 100 between its proximal handle 22 and distal end 14, such as a fluid lumen for carrying fluid introduced through a fluid port 26 and various conductive wires entering through one or more wire ports 24. In some embodiments, the handle 22 is configured to receive a guidewire through a guidewire lumen in the extension tube 12 and to assist in the insertion and positioning of the distal end 14 of the catheter 100. In such embodiments, the guidewire may be inserted inside the stretching tube 12 to position the inclusion body at the distal end 14 of the catheter in close proximity to the lesion in the body lumen. However, in some embodiments, the stretching tube 12 does not include a guidewire lumen.

[0181] In some aspects, the encapsulant of the catheter 100 may be wrapped circumferentially around a portion of the stretch tube 12 and sealed to a region of the stretch tube, for example, via a seal. In the retracted state, the encapsulant may be positioned in close proximity to the stretch tube 12 and optionally in a folded state, which improves the maneuverability of the catheter 100 during insertion and positioning. The encapsulant may be filled with a conductive fluid, such as saline, so that the encapsulant expands (i.e., inflates) and comes into contact with a body lumen (such as the wall of an artery proximal to a calcified lesion). When expanded, the encapsulant provides an annular channel around the stretch tube 12 and creates a space between the emitter of the assembly and the inner surface of the encapsulant. In one or more embodiments, the conductive fluid may also contain an X-ray contrast fluid to allow fluoroscopic visualization of the catheter 100 by the surgeon during use.

[0182] System 10 also includes a power supply 28 (e.g., a high-voltage pulse generator or laser, shown in Figure 1 as an endovascular lithotripsy "IVL generator") configured to power a shock wave emitter and generate shock waves during treatment using the catheter 100. For electrohydraulic generation of acoustic shock waves, a conductive solution (e.g., saline solution) may be contained within an enclosure surrounding the electrode or flushed through a tube surrounding the electrode. A voltage pulse may be delivered from the power supply 28 to the emitter, resulting in a discharge across the electrode. This discharge generates one or more rapidly expanding vapor bubbles that produce acoustic shock waves. These shock waves propagate rapidly outward, correcting calcified plaque within the blood vessel. For treatment of intravascular occlusion, the voltage pulse applied by the power supply 28 is typically in the range of approximately 500–3,000 volts (500V–3,000V). In some implementations, the voltage pulses applied by the voltage source are up to approximately 10,000 volts (10,000 V), or may be higher than 10,000 volts (10,000 V). The pulse width of the applied voltage pulses ranges from 2 microseconds to 6 microseconds (2 to 6 μseconds). The repetition rate or frequency of the applied voltage pulses may be approximately 1 Hz to 10 Hz. The total number of pulses applied by the power supply 28 may be, for example, 60 (60) pulses, 80 (80) pulses, 120 (120) pulses, 300 (300) pulses, or up to 500 (500) pulses, or other increments of pulses within this range. Alternatively, or in addition, in some embodiments, the power supply 28 may be configured to deliver packets of micropulses having sub-frequencies of approximately 100 Hz to 10 kHz. The preferred voltage, repetition rate, and number of pulses may vary depending, for example, the size of the lesion, the degree of calcification, the size of the blood vessel, the patient's attributes, or the stage of treatment. For example, a physician may start with a low-energy shock wave and increase the energy as needed during the procedure, or vice versa. The magnitude of the shock wave can be controlled by controlling the voltage, current, duration, and repetition rate of the pulsed voltage from the power supply 28.

[0183] In alternative implementations, for laser generation of acoustic shock waves, power supply 28 generates laser pulses that are transmitted into the fluid within the catheter and thereby absorbed. This absorption process rapidly heats and vaporizes the fluid, thereby generating rapidly expanding vapor bubbles and acoustic shock waves that propagate outward and correct calcified plaque. The intensity of the acoustic shock wave is higher when a fluid exhibiting strong absorption at the employed laser wavelength is selected. Therefore, while some shock wave devices described herein generate shock waves based on high-voltage pulses applied to electrodes, it should be understood that shock wave devices may, in addition to or alternatively, use laser pulses transmitted through optical fibers to generate shock waves, and the “emitters” and “shock wave generating regions” described herein may include the output ends of the optical fibers. These embodiments are not intended to be a comprehensive list of potential energy sources for generating shock waves in shock wave catheters.

[0184] To operate the catheter 100, the physician optionally inserts a guidewire into a body lumen. The physician then positions the stretcher 12 along the proximal end of the guidewire so that the guidewire extends through the stretcher 12, and uses the guidewire to guide the stretcher 12 to a position close to a lesion in the body lumen, such as a lesion in a blood vessel or valve. Once positioned, the inclusion can optionally be filled with conductive fluid through the filling port 26 so that the inclusion expands and makes contact with the wall of the body lumen. As further described below, at least one of the emitters inside the inclusion can be moved outward with respect to the longitudinal axis of the catheter to reduce the distance between the emitter and the lesion. The power supply 28 is then used to deliver one or more high-voltage pulses to the emitter to generate one or more shock waves within the inclusion and within the body lumen being treated. Generally, shock waves propagate outward toward the inner surface of the inclusion body, through the material of the inclusion body, into the lesion in the adjacent body lumen, where the shock wave energy destroys the hardened plaque.

[0185] In some embodiments, the magnitude of the shock wave can be controlled by controlling the magnitude, current, duration, and repetition rate of the pulsed voltage supplied by the power supply 28. Furthermore, in embodiments where one or more emitters are wired on separate circuits or separate circuit branches and operate independently, the user of the catheter 100 may selectively emit shock waves only in that subset of the emitters of the catheter by applying a voltage to generate shock waves only in a particular subset of the emitters. The physician may start with low-energy shock waves and increase the energy as needed to break up lesions and calcified plaques. In some embodiments, the physician may initially generate shock waves in a first subset of the emitters (e.g., a distal subset of the emitters) and continue treatment by generating shock waves in a second subset of the emitters (e.g., a central or proximal subset of the emitters). Repeated shock waves can be delivered, and the catheter 100 may be repositioned or further advanced in the body lumen to continue treatment. Once the shock wave therapy is complete, the inclusion body shrinks, and the distal end 14 of the catheter 100 can be removed from the body lumen.

[0186] Figures 2A-2B, 3A-3B, and 4A-4C illustrate the distal end of various embodiments of catheter 100, which include an expandable support structure for positioning at least one emitter closer to a lesion in a body lumen. The exemplary catheters 200A-D in Figures 2A-2B, 3A-3B, and 4A-4C each include an extension tube 202 and an inclusion body 252 which is optionally sealed in a region of the extension tube near its distal end in a seal 253. The inclusion body 252 includes a distal end 254 and a proximal end 256 opposite the distal end. Catheters 200A-D include an expandable support structure 210A-D, various embodiments of which are shown in Figures 2A-2B, 3A-3B, and 4A-4C. In some embodiments, the catheter 200A-D also includes a distal end tube 203 that is aligned with the longitudinal axis of the extension tube 202 and connects to the distal end of the support structure 210A-D (for example, a portion of the distal end tube 203 is visible in Figures 2A-2B). The distal end tube 203 may anchor the expandable support structure along the central longitudinal axis and, in some embodiments, may include a stop mechanism for controlling the expansion of the support structure, such as the stop mechanism shown in Figures 5A-5B. At least one emitter (e.g., a first emitter 222, a second emitter 224, and a third emitter 226) is supported by the expandable support structure 210A-D. In the collapsed state, the expandable support structure 210A-D may have a relatively thin profile. The expandable support structure 210A-D may be in a collapsed state during the insertion and positioning of the catheter 200A-D within the body lumen. Once the catheter 200A-D is positioned within the body lumen near the lesion and the inclusion is expanded using a conductive fluid, the expandable support structure 210A-D can expand to a diameter exceeding the diameter of the support structure in the collapsed state. For example, the expandable support structure 210A-D may be expandable from a collapsed diameter of approximately 1 millimeter (1 mm) or less to a diameter of at least 5 millimeters (5 mm), at least 8 millimeters (8 mm), or at least 1 centimeter (1 cm).In some embodiments, the expanded diameter of the support structure is approximately 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 10 mm, or 12 mm. In some embodiments, the expanded diameter of the support structure is less than the expanded diameter of the inclusion body 252, for example, to prevent contact between the inner surface of the inclusion body and the emitters 222, 224, and 226. In one or more embodiments, when the support structure is expanded within the inclusion body, the support structure is at least 3 / 4 mm (0.75 mm) away from the wall of the inclusion body. In some embodiments, when the support structure is expanded, the support structure is at least 3 / 4 mm (0.75 mm) away from the wall of the inclusion body, or at least 1 cm (1 cm) away from the wall of the inclusion body. In other embodiments, one or more emitters are movably connected to the extension tube such that, in the first configuration, at least one emitter is in a first position, and in the second configuration, at least one emitter is in a second position. The second position may be at least 3 millimeters (3 mm) further from the central longitudinal axis than the first position. In other embodiments, the second position is at least 6 millimeters (6 mm) or 1 centimeter (1 cm) further from the central longitudinal axis than the first position.

[0187] Figures 2A-2B illustrate the distal end of an exemplary catheter 200A, including an embodiment of the expandable support structure 210A. Figure 2A illustrates the expandable support structure 210A in a collapsed state, and Figure 2B illustrates the expandable support structure 210A in an expanded state, in which the emitters 222, 224, and 226 are positioned further from the central longitudinal axis and closer to the body lumen. The expandable support structure 210A includes a plurality of compartments (e.g., a first compartment 212, a second compartment 215, and a third joint 217) connected by individual joints (e.g., a first joint 213, a second joint 215, and a third joint 217), and at least one emitter positioned on the support structure.

[0188] When the support structure 210A is extended, one or more of the individual joints 213, 215, and 217 are configured to hinge, moving the joint and a portion of the adjacent section outward with respect to the longitudinal axis of the extension tube. In a more specific embodiment, the joints of the support structure may be configured to hinge in alternating directions such that the support structure extends in a zigzag or accordion shape, and the successive sections of the support structure fold toward each other, pushing the joint outward from the central longitudinal axis. For example, as seen in Figure 2B, a first joint (e.g., 213) may move laterally in a first direction with respect to the central longitudinal axis, while a second joint (e.g., 215) may move laterally in a second direction opposite to the first direction. In such embodiments, a first emitter (e.g., 222) mounted in close proximity to the first joint 213 may move laterally from the central longitudinal axis in a first direction, and a second emitter (e.g., 224) mounted in close proximity to the second joint 215 may move laterally from the central longitudinal axis in a second direction opposite to the first direction.

[0189] The expandable support structure may be formed from a rigid material such as metal (e.g., stainless steel) or a rigid polymer. In some embodiments, at least a portion of the expandable support structure is formed from a flexible or semi-flexible material such as a flexible polymer. For example, each of joints 213, 215, and 217, a portion of the joint, and / or a region adjacent to the joint may be relatively flexible than the section (e.g., formed from a relatively more flexible material, or otherwise modified to be more flexible), and thus the support structure 210A is configured to bend at each of the joints when the structure is in an expanded state. In another embodiment, each joint is a mechanical hinge connecting to an adjacent section of the support structure. In certain embodiments, one or more of the joints may be living hinges, i.e., thin flexible hinges made from the same material as the adjacent section, and optionally, thinned regions of the same material. In some embodiments, sections 212, 214, 216, and 218 may be formed from a material that is relatively more rigid than the joint.

[0190] In some embodiments, one or more of compartments 212, 214, 216, and 218 include individual openings 219 extending through the compartment. The openings 219 may be positioned approximately in the center of the compartment such that, when the support structure 210A is in an expanded state, the openings align with the central longitudinal axis of the catheter 200A. In one embodiment, the expandable support structure 210A includes a series of openings 219 on a plurality of compartments, each opening 219 positioned on an individual compartment such that the central longitudinal axis of the catheter 200A (e.g., the central longitudinal axis of the extension tube) extends through each of the openings. In some embodiments, an extension member 242, such as a wire, may extend through one or more of the openings and be used to control the expansion of the support structure, as will be described in more detail below. In some embodiments, the extension member 242 extends along the longitudinal axis.

[0191] In some embodiments, one or more emitters (e.g., emitter 222) are located on the support structure 210A in close proximity to or adjacent to one or more joints (e.g., mounted on one of the compartments in close proximity to a joint, or on or adjacent to the joint itself). For example, in the embodiment of Figures 2A-2B, the first emitter 222 is located in close proximity to the first joint 213 of the support structure 210A, the second emitter 224 is located in close proximity to the second joint 215 of the support structure 210A, and the third emitter 226 is located in close proximity to the third joint 217 of the support structure 210A. In some embodiments, two or more emitters are located on each side of individual joints of the support structure. In some embodiments, the first electrode of the emitter is located on a first section of the support structure, and the second electrode of the emitter is located on a second section of the support structure, so that the spark gap between the electrodes is near the joint of the support structure 210A. In some embodiments, the emitter is located on a region of the support structure that is furthest from the longitudinal axis and / or closest to the wall of the inclusion body 252 when the support structure is expanded. The emitter may be oriented such that when the support structure 210A is expanded, shock waves generated from one or more of the emitters propagate outward from the central longitudinal axis of the catheter.

[0192] The catheter 200A is illustrated with three emitters 222, 224, and 226 located adjacent to three joints 213, 215, and 217 of the support structure 210A. However, this is provided for illustrative purposes only, and the catheter may include any number of emitters located within the inclusion body. In some embodiments, for example, additional emitters may be included within the distal portion of the inclusion body and oriented for forward deflection emission of shock waves.

[0193] Figures 3A–3B illustrate the distal end of another exemplary catheter 200B, including a second embodiment of the expandable support structure 210B. Figure 3A illustrates the expandable support structures 210A–D in a collapsed state, and Figure 3B illustrates the expandable support structures 210A–D in an expanded state. The support structure 210B within the catheter 200B expands laterally from the central longitudinal axis 201 of the catheter, moving the emitters (e.g., a first emitter 222, a second emitter 224, a third emitter 226, and a fourth emitter 228) positioned on the support structure laterally from the central longitudinal axis. In some embodiments, expanding the support structure 210B moves the emitters three-dimensionally along one or more planes that intersect and are coplanar with the longitudinal axis.

[0194] The exemplary expandable support structure 210B optionally includes multiple expansion regions (e.g., a first expansion region 262, a second expansion region 264, and a third expansion region 266) connected by separate nodes between each of the individual expansion regions (e.g., a first node 263 and a second node 265). However, the expandable support structure may include any number of expansion regions, such as a single expansion region, two expansion regions, three expansion regions, four expansion regions, or more than four expansion regions. Each expansion region of the support structure may have one or more emitters positioned on that region. When the support structure 210B is in a collapsed state, the expansion regions and nodes may each be substantially aligned with the central longitudinal axis of the catheter. When the support structures 210A-D expand, the nodes may each move further together, causing the expansion regions to expand outward from the central longitudinal axis. In some embodiments, as shown in Figure 3B, the extension regions 262, 264, and 266 are each configured to extend laterally in at least one transverse direction with respect to the longitudinal axis. In some embodiments, the extension regions are each configured to extend laterally in multiple transverse directions with respect to the central longitudinal axis.

[0195] In some embodiments, the expansion regions 262, 264, and 266 each include flexible joints (e.g., a first joint 272, a second joint 274, and a third joint 276) configured to hinge when the support structure 210B is in an expanded state. In some embodiments, one or more of the flexible joints are living hinges, i.e., thin flexible hinges made from the same material as the expansion region, and optionally, thinned regions of the same material. In some embodiments, portions of the expansion regions 262, 264, and 266 near nodes 263 and 265 are formed from a material that is relatively more rigid than portions of the expansion region near the joints. When the support structure 210B is expanded, the expansion regions 262, 264, and 266 each are configured to bend inward at the individual joints 272, 274, and 276, causing at least one emitter located on the joint and the expandable support structure to move outward with respect to the longitudinal axis of the extension tube.

[0196] The support structure 210B may be formed from a flexible and resilient material that can be maneuvered through the blood vessels to the site of shock wave therapy and can maintain its shape after multiple expansions. For example, the material of the support structure may be selected such that, after the support structure has been expanded, it can return to substantially the same configuration in a collapsed state. In some embodiments, the material of the support structure can be repeatedly expanded and collapsed without deforming the shape of the material in the expanded or collapsed state. The expandable support structure may be formed from a flexible or semi-flexible material such as a thin metal (e.g., stainless steel) or a flexible polymer. In some embodiments, at least a portion of the expandable support structure is formed from a flexible material such as a flexible polymer.

[0197] In some embodiments, the material properties of the expandable support structure 210B bias the structure to either an expanded or collapsed state. For example, the material of the expandable support structure may be biased such that the support structure is either expanded or collapsed in its natural or relaxed state, i.e., when no external force is applied to the support structure. Changing the state of the support structure (i.e., expanding or collapsing the support structure) may therefore involve applying a force to the support structure. In some embodiments, collapsing or expanding the support structure involves applying an axial force to the support structure in either the proximal or distal direction.

[0198] Optionally, the expandable support structure 210B includes one or more springs (e.g., 269) configured to bias the support structure into a collapsed or expanded state. The springs may apply axial tension to the support structure to maintain it in a collapsed or expanded state (e.g., by applying tension on one or more ends of the support structure in either the proximal or distal direction). In such embodiments, the user applies force to the springs to expand the support structure and move the emitter toward the balloon wall, or alternatively, compress the support structure into a longitudinally compressed state. In some embodiments, an extension member 242, operably coupled to a portion of the support structure, may be used to apply axial force to the support structure and control the expansion and compression of the support structure. In one or more embodiments, the springs are connected to the proximal end of the support structure to bias the support structure into a lateral collapsed state. In this configuration, the user applies force to the springs to change the configuration to a laterally expanded state. After treatment, the springs facilitate the return of the support structure to a collapsed state.

[0199] At least one emitter (e.g., a first emitter 222, a second emitter 224, a third emitter 226, and a fourth emitter 228) is located within the encapsulation body 252. One or more of the at least one emitter is supported by the support structure 210B (i.e., it is located on and / or mounted on it). Any number of emitters located on the support structure 210B may be configured to move outward from the central longitudinal axis 201 when the support structure is extended. The emitters 222, 224, 226, and 228 may optionally be located on the extended regions 262, 264, and 266 of the support structure, in close proximity to the flexible joints 272, 274, and 276. In some embodiments, emitters 222, 224, 226, and 228 are located on the region of the support structure that is furthest from the longitudinal axis and / or closest to the wall of the encapsulation when the support structure 210B is in an extended state.

[0200] In some embodiments, one or more emitters are located on adjacent extension regions of the support structure (e.g., extension regions 262, 264) and are configured to move outward in the same direction along a plane that intersects and is coplanar with the central longitudinal axis, for example, the first emitter 222 and the third emitter 226 extend laterally in the same direction (as depicted upward in Figures 2A, 2B, 3A, and 3B). In some embodiments, one or more emitters are located on the same extension region (e.g., 262) and are configured to move laterally in opposite directions along a plane that intersects the central longitudinal axis (for example, the first emitter 222 and the second emitter 224 extend laterally in opposite directions and are shown in the drawings as extending upward and downward, respectively).

[0201] In some embodiments, emitters 222, 224, 226, and 228 are positioned on support structures 210A-D such that they move laterally from the central longitudinal axis 201 along multiple planes that intersect and are coplanar with the longitudinal axis (for example, to move multiple emitters outward from the central longitudinal axis in three dimensions). Advantageously, such a configuration would allow the catheter 200B to target lesions located around the circumference of a body lumen, or a larger circumferential area of ​​a body lumen than could be targeted using a support structure that expands two-dimensionally. In some embodiments, the emitters are configured to move outward from the central longitudinal axis such that they are evenly spaced around the circumference of the inclusion body and / or body lumen. For example, the emitters may be spaced about 30, 45, 60, 90, or 120 degrees around the circumference when the support structure 210B is in an expanded configuration. In such embodiments, the emitter is configured to move along a plurality of planes that intersect each other along the longitudinal axis, and the individual planes may be oriented at 30 degrees, 45 degrees, 60 degrees, 90 degrees, or 120 degrees away from the central longitudinal axis of the catheter.

[0202] The catheter 200B in Figures 3A-3B is illustrated with six emitters located on a support structure, having three expansion regions that move outward when the catheter is expanded, with one pair of emitters positioned above each of the expansion regions. However, the catheter may have fewer than six emitters or more than six emitters within the inclusion. For example, in some embodiments, each expansion region 262, 264, 266 may contain one emitter, three emitters, four emitters, six emitters, eight emitters, or more than eight emitters. In some embodiments, the catheter includes one or more additional emitters located near the distal tip of the expandable support structure.

[0203] Figures 4A–4C illustrate various cross-sections of the distal end of an exemplary catheter, viewed along the central longitudinal axis 201 of the catheter, showing various support structures 210A, 210C, and 210D in the expanded state. Figure 4A illustrates the support structure 210A of catheter 200A in Figures 2A and 2B, including at least two emitters (e.g., a first emitter 222 and a second emitter 224), with the emitters spaced 180 degrees around the circumference of the inclusion body 252. Figure 4B illustrates the support structure 210C of catheter 200C, including at least three emitters (e.g., a first emitter 222, a second emitter 224, and a third emitter 226), with the emitters spaced 120 degrees around the circumference of the inclusion body 252. Figure 4C illustrates a support structure 210D for the catheter 200D, which includes at least four emitters (e.g., a first emitter 222, a second emitter 224, a third emitter 226, and a fourth emitter 228), the emitters spaced 90 degrees apart around the circumference of the inclusion body 252. However, as mentioned above, the catheter may include any number of emitters, and the emitters may be configured to expand outward in any desired direction with respect to the central longitudinal axis, positioning the emitters closer to the inner wall of the inclusion body 252 and / or the lesion in the body lumen.

[0204] In catheter 200A shown in Figure 4A, expansion of the support structure 210A moves emitters 222, 224 outward from the longitudinal axis in two opposing directions, positioning the emitters close to the opposite side of the wall of the encapsulation body 252. In some embodiments, the emitters move along the two-dimensional plane when the support structure is expanded (for example, in two opposing directions along the same two-dimensional plane). In exemplary catheter 200C in Figure 4B, expansion of the support structure 210C moves three emitters 222, 224, and 226 outward from the central longitudinal axis 201 in three directions that are relative to each other and transverse to the central longitudinal axis 201. In exemplary catheter 200D in Figure 4C, expansion of the support structure 210D moves four emitters 222, 224, 226, and 228 outward from the longitudinal axis 201 in four directions. For example, expansion of the support structure may move the first emitter 222 outward from the central longitudinal axis 201 along the first plane, and the second emitter 224 outward from the longitudinal axis along the second plane which is transverse to the first plane. In some embodiments, the first plane is perpendicular to the second plane, and therefore, when the support structure 210A-D is expanded, the first emitter 222 and the second emitter 224 are positioned about 90 degrees apart from each other around the circumference of the encapsulation body 252 or body lumen. However, in alternative embodiments, the planes may intersect at some other angle (e.g., 30 degrees, 45 degrees, 60 degrees, or 120 degrees), so that the first emitter 222 and the second emitter are positioned about 30, 45, 60, or 120 degrees apart from each other around the circumference of the encasing or body lumen. In some embodiments, two or more of the emitters may move in the same or opposite directions along the same two-dimensional plane intersecting the longitudinal axis 201. For example, in certain embodiments, expansion of the support structure moves the first emitter 222 and the third emitter 226 in opposite directions along the first plane, and the second emitter 224 and the fourth emitter 228 in opposite directions along a second plane that is transverse to the first plane. In some embodiments, the first and second planes are perpendicular.Additional or alternative emitter configurations are also anticipated.

[0205] In some embodiments, it may be advantageous to position one or more emitters closer to the lesion by rotating the distal end of the catheter within the body lumen. As shown in Figures 4A-4C, in some embodiments, the emitters are arranged such that expanding the support structure 210A-D moves the emitters closer to only a portion of the body lumen wall (e.g., only a specific side of the lumen or two opposing sides). In some embodiments, during use, the physician may sequentially treat portions of the body lumen by rotating the extension tube 202 or extension member 242, rotating the support structure 210A-D within the body lumen, and positioning at least one emitter near a new portion of the body lumen wall. For example, the physician may incrementally rotate the support structure 210A-D and the emitters in a clockwise direction to treat the entire circumference of the body lumen during shock wave therapy.

[0206] Power (e.g., voltage) can be supplied to any of the emitters in catheters 200A-D using one or more conductive wires (e.g., insulated copper wires) that are electrically connected to at least one of the emitters inside the containment. However, as mentioned above, in other embodiments, power may be supplied to the emitters by one or more optical fibers connected to at least one of the emitters. Turning back to Figures 2A-2B, one or more conductive wires (e.g., a first wire 232 and a second wire 234) may extend into the interior of the containment 252 along at least a portion of the extension tube 202 and provide an electrical connection between an external power source and one or more of the emitters located on the support structure 210A-D. In some embodiments, the conductive wires 232, 234 may fold within the containment as the containment is inserted and advanced through the body lumen.

[0207] In some embodiments, conductive wires 232, 234 extend along at least a portion of the expandable support structure 210A-D (e.g., along sections and / or individual joints of the support structure in Figures 2A-2B, or along expansion regions, joints, and / or nodes of the support structure in Figures 3A-3B). In some embodiments, conductive wires 232, 234 are fixed to the expandable support structure at one or more points, for example, via adhesive. Conductive wires 232, 234 may optionally include some degree of flexure so that the wires do not provide physical resistance when the support structure 210A-D is expanded and compressed. Wires 232, 234 may have flexure when the support structure 210A-D is compressed and relatively more tension when the support structure is expanded. For example, wires 232, 234 may include additional lengths adjacent to each of the joints of the support structure.

[0208] In other embodiments, the conductive wires 232, 234 extend freely within the encapsulation 252 between one or more emitters and are not bonded or fixed to the support structure. In further embodiments, one or more of the conductive wires 232, 234 may be bonded to the inner surface of the encapsulation 252. For example, the conductive wires 232, 234 extend along the inner wall of the encapsulation and may optionally be bonded to the inner surface of the encapsulation at one or more points along the inner surface, for example, via an adhesive. In yet another embodiment, at least a portion of the expandable support structure 210A-D may be conductive and configured to supply voltage to one or more emitters. For example, the support structure 210A-D may be formed from one or more conductive wires or a conductive mesh covered with an insulating layer, the portion of which is removed from the support structure and provides one or more conductive portions that act as paired electrodes of the emitters.

[0209] In some embodiments, the emitters are connected in series, and therefore, as current flows across the spark gap between the individual electrodes of the series-connected emitters, a voltage pulse from the power supply generates shock waves in all of the emitters. The emitters may be connected in series in a particular order that is advantageous for shock wave therapy. For example, in some embodiments, a voltage pulse from a voltage source first causes current to flow through the emitters in the more distal region of the inclusion body, generating shock waves to treat the more distal portion of the lesion in the body lumen, and then causes current to flow through the emitters in the more proximal region of the inclusion body, generating shock waves to treat the more proximal region of the body lumen.

[0210] In another embodiment, one or more emitters may be wired on a separate circuit or separate circuit branch so that a voltage pulse can be selectively applied to only a desired subset of the emitters, thereby generating a shock wave in the desired subset. For example, in one embodiment, one or more distal emitters may be wired together (i.e., wired in series) in a separate circuit or circuit branch from another subset of emitters so that a shock wave can be selectively generated in the more distal portion of the balloon. In another embodiment, emitters moving in the same direction with respect to the longitudinal axis 201 or along the same plane may be wired together in a circuit or circuit branch so that a shock wave can be selectively generated on a certain side of the balloon, i.e., to treat a non-concentric lesion located on a specific side of a body lumen. The emitters may be wired in a separate circuit or circuit branch from one or more further emitters configured to move outward in different directions or along different planes.

[0211] In some embodiments, the catheter includes an extension member 242 which can be actuated by the catheter user to expand and collapse a support structure, for example, one of the support structures shown in Figures 2A-2B, 3A-3B, and 4A-4C and described herein. After positioning the catheter 200A-D in a body lumen and inflating the inclusion body 252, the catheter user can move the extension member 242 in a proximal or distal direction to expand the support structure 210A-D to its expanded diameter and position the emitter closer to the lesion in the body lumen. After completing shock wave therapy, the user can move the extension member 242 in either a proximal or distal direction to collapse the support structure 210A-D, and the catheter 200A-D can be removed from the body lumen.

[0212] An exemplary extension member 242 is shown in Figures 2A-2B; however, extension members may be used to extend any of the support structures shown in Figures 2A-2B, 3A-3B, and 4A-4C and described herein. The extension member 242 optionally extends along the longitudinal axis 201 of the catheter extension tube through at least a portion of the encapsulation body 252 and / or support structure 210. In some embodiments, such as the catheter 200A shown in Figures 2A-2B, the support structure 210A includes one or more openings 219, and the extension member 242 extends through one or more of these openings. The extension member 242 may extend substantially coincide with the longitudinal axis 201 of the catheter so that movement of the extension member by the catheter user in the proximal or distal direction does not produce a moment arm relative to the longitudinal axis 201.

[0213] The extension member 242 may be any suitable extension component extending along the length of the catheter 200A-D between the support structure 210A-D near the distal end of the catheter and the proximal end of the catheter outside the body lumen, where the extension member can be actuated by the user of the catheter. For example, in some embodiments, the extension member 242 includes a flexible tube or shaft, and moving the flexible tube or shaft in the proximal or distal direction expands or contracts the support structure. The flexible tube or shaft may surround at least a portion of the extension tube such that movement of the flexible tube or shaft in the proximal or distal direction relative to the extension tube causes expansion of the support structure. In certain embodiments, the extension member 242 includes an inner shaft and an outer shaft concentric with the inner shaft and at least partially surrounding it. In such embodiments, movement of the outer shaft in the proximal or distal direction relative to the inner shaft expands or contracts the support structure 210A-D. In further embodiments, as shown in Figures 2A-2B, the extension member 242 may include a wire, and pulling the wire in the proximal direction causes the support structure 210A-D to expand.

[0214] In some embodiments, the expanded diameter of the support structure 210A-D can be controlled by moving the extension member 242 by a variable amount in the proximal or distal direction. For example, moving the extension member 242 by a first amount can expand the support structure 210A-D to a first expanded diameter, and moving the extension member by a second amount can expand the diameter to a second expanded diameter. In such embodiments, a visual indicator may be provided on the extension member 242 or another part of the catheter 200A-D to assist the user in expanding the support structure 210A-D to a desired diameter by moving the extension member according to the visual indicator. In some embodiments, for example, the extension member 242 includes one or more markings that indicate to the user the amount of movement of the extension member associated with one or more expanded diameters of the support structure 210.

[0215] Advantageously, controlling the expansion diameter of the support structure 210A-D may allow the catheter 200A-D to access and / or treat areas of body lumens having relatively larger or smaller diameters. For example, the catheter 200A-D may be advanced through a relatively narrower vessel before being positioned in close proximity to a relatively larger vessel or valve, and the support structure 210A-D may then be expanded to the desired size for treating the vessel or valve. In some cases, a single shock wave treatment may involve treating body lumens having different diameters or different morphologies of lesions. For example, adjusting the diameter of the support structure may be advantageous for treating eccentric or nodular calcified lesions or more completely occluded areas of a vessel. In such situations, the expansion diameter of the support structure may be controlled during the shock wave treatment (i.e., when the catheter is positioned in the body lumen) to control the position of the emitter closer to the lesion in the body lumen. Providing a support structure with a controllable diameter is also advantageous, as it allows the support structure to be adapted to catheters with various different diameters of inclusions (e.g., angioplasty balloons). Additional advantages are also anticipated.

[0216] In embodiments where the expansion diameter of the support structure 210A-D is controllable or adjustable, the support structure may nevertheless have a maximum expansion diameter. Over-expansion of the support structure may pose a risk of rupturing the inclusion or damaging the wall of the body lumen when the catheter is positioned in its original location. To mitigate the risk of over-expansion, in some embodiments, expanding the support structure to a specific expansion diameter is reversibly locked in the expanded state. For example, in the exemplary catheter 200B of Figures 3A-3B, one or more of the compartments may include an upper arm that prevents over-expansion of the support structure 210. The user of the catheter 200B can then, for example, press a button or actuate the extension member 242 in the proximal or distal direction to release the expandable support structure 210B, collapse the support structure, and subsequently remove it from the body lumen.

[0217] In some embodiments, the catheter includes a first stop and a second stop, and expanding the support structure includes moving the first stop relative to the second stop. Figures 5A-5C illustrate an exemplary configuration of a first stop 282 and a second stop 284 for controlling the expansion and collapse of the catheter support structure. For example, moving the first stop toward the second stop may expand the support structure outward with respect to the longitudinal axis of the catheter, and moving the first stop toward the second stop may collapse the support structure closer to the longitudinal axis. The first and second stop 282, 284 may be configured to move axially along the longitudinal axis of the catheter and may be controllable via the axial movement of an extension member (e.g., an extension member 242 shown in Figures 2A-2B).

[0218] In some embodiments, the first stop 282 and the second stop 284 are separated when the support structure 210A-D is in a collapsed state and are in contact when the support structure is in an expanded state. However, in other embodiments, as shown in Figures 5A-5C, the first stop 282 and the second stop 284 are separated by the separating element 286 such that one or more of the first stop 282 and the second stop 284 are separated from the separating element when the support structure is in a collapsed state, and both the first stop 282 and the second stop 284 are in contact with the separating element 286 when the support structure is in an expanded state. Figure 5A shows the first stop 282 separated from the separating element 286 and the second stop 284 in contact with the separating element 286 while the support structure is in a collapsed state. Expanding the support structure 210A-D may therefore involve moving the first stop 282 to contact the separation element 286 and / or moving the first stop 282 closer to the second stop 284. As seen in Figure 5B, when the first stop 282 is in contact with the separation element 286, the support structure 210A-D is fully expanded. However, it should be noted that either the first stop 282 or the second stop 284 may be moved relative to the other stop and the separation element 286 (and in either the proximal or distal direction) to expand or contract the support structure 210A-D. As mentioned above, the degree of expansion of the support structure 210A-D (i.e., the expanded diameter of the support structure) may be controlled by moving the first stop 282 and the second stop 284 by relatively greater or lesser amounts relative to each other. In some embodiments, the second stopper 284 is moved further away from the first stopper 282 and / or the separating element 286 in order to crush the support structure 210A-D.

[0219] In such embodiments, the extension member 242 is operably coupled to at least one of the first stop 282 and the second stop 284 such that movement of the extension member 242 causes the first stop to move relative to the second stop, thereby expanding and / or collapsing the support structure. For example, in embodiments where the extension member 242 is a wire, the wire may extend between the first stop 282 and the second stop 284 and be operably coupled to at least one of them. Movement of the wire in the proximal direction (e.g., pulling the wire) can cause expansion of the support structure by moving, for example, the first stop 282 operably coupled to the wire closer to the second stop 284 or separating element 286 which remain stationary on the catheter. In another embodiment, the extension member 242 may be a flexible tube or shaft that is operably coupled to at least one of the first and second stoppers, such that moving the flexible tube or shaft in a proximal or distal direction moves the first stopper 282 relative to the second stopper 284 and expands the support structure 210A-D. In another embodiment, the first shaft is operably coupled to the first stopper 282, and the second shaft, which at least partially surrounds the first shaft, is operably coupled to the second stopper 284, such that moving the first shaft relative to the second shaft moves the first stopper relative to the second stopper and expands the support structure.

[0220] In some embodiments, one or more of the first stopper 282 and the second stopper 284 are contained within a portion of the support structure 210. For example, the first stopper 282 may be a first joint of the support structure, and the second stopper 284 may be a second joint of the support structure 210, so that the support structure can be expanded by pulling the first joint of the support structure closer to the second joint of the structure. Alternatively, the first stopper 282 and the second stopper 284 may be contained within a portion of a catheter located proximal or distal to the encapsulant and expandable support structure. For example, the first stopper 282 and the second stopper 284 may be contained within a portion of the extension tube or within another part of the catheter (e.g., the handle).

[0221] In some embodiments, the shock wave catheter includes multiple inclusions at its distal end, and the inflation of various inclusions can be used to position a desired emitter or cluster of emitters closer to a body lumen. Figures 6A-6C and 7A-7C illustrate the distal ends of various exemplary shock wave balloon catheters 300A-C, which have various multi-balloon arrangements for positioning at least one emitter closer to a lesion in a body lumen. Catheter 300A-C is an embodiment of catheter 100 shown in Figure 1.

[0222] Once the catheter 300A-C is advanced through the body lumen and positioned in close proximity to the lesion within the body lumen, one or more of the inclusions can be inflated using a conductive fluid so that at least one of the inclusions is in contact with the body lumen. The relative expansion of the inclusions can be used to modulate the distance between the emitter and the body lumen and to position at least one emitter in close proximity to the lesion within the body lumen. After the inclusions have been inflated, one or more shock waves can be generated at the emitter to treat the lesion. Once the shock wave therapy is complete, each inclusion is deflated, and the distal end of the catheter 300A-C can be removed from the body lumen.

[0223] Figures 6A-6C illustrate side cross-sectional views of various exemplary multi-balloon shock wave catheters 300A-C, and Figures 7A-7C illustrate axial or longitudinal cross-sectional views of exemplary catheters 300A-C. The catheter 300A-C comprises at least one stretcher tube and a plurality of inclusions, e.g., a first inclusion 352 and at least one further inclusion, which optionally have one or more inclusions sealed in a region of the first stretcher tube 302 or a further stretcher tube (e.g., a second stretcher tube 304 or a third stretcher tube 306). In some embodiments, the first stretcher tube 302 defines the central longitudinal axis 301 of the catheter 300. However, in other embodiments, the first stretcher tube 302 is offset from the longitudinal axis 301 of the catheter. As described below, in some embodiments, the catheter 300A-C includes two or more extension tubes (e.g., a second extension tube 304, a third extension tube 306, and / or a fourth extension tube 308), and the multiple extension tubes provide, for example, a fluid inlet, a conductive wire, and other connections to each of the multiple encapsulations. In such embodiments, one or more of the tubes may be aligned with the longitudinal axis 301 of the catheter. In the distal region of the catheter 300, one or more of the extension tubes 302, 304, 306, and 308 may be offset from the longitudinal axis 301 and extend into encapsulations that are offset from the axis. In further embodiments, as shown in Figures 6A-6B, the catheter extension tube may branch at its distal end and form one or more further extension tubes (e.g., a first extension tube 302, a second extension tube 304, a third extension tube 306, and a fourth extension tube 308) extending into one or more inclusions provided at the distal end of the catheter.

[0224] The first inclusion body 352 surrounds at least one emitter 222 located within the inclusion body and is fillable with a conductive fluid, forming an annular channel around the extension tube, where at least one emitter can generate shock waves in the conductive fluid. Optionally, the first inclusion body 352 is sealed in a region of the first extension tube 302. The first inclusion body 352 (and any further inclusion bodies such as the second inclusion body 354, the third inclusion body 356, and / or the fourth inclusion body 358) may be an angioplasty balloon, as described above, and may be configured to inflate and contact the wall of a body lumen. However, in other embodiments, the material of the first and / or further inclusion bodies may be thicker than conventional angioplasty balloons or may expand in a relatively smaller amount than conventional angioplasty balloons.

[0225] At least one emitter 322 is configured to generate a shock wave inside the first encapsulation body 352 when power is supplied to at least one emitter. Each emitter includes at least one electrode pair, the electrodes of each pair may be spaced apart from each other to form a spark gap between the electrodes, through which a shock wave can be generated. However, as described above, the emitter may also include an optical fiber configured to transmit energy from a laser source and generate a shock wave. Optionally, at least one emitter may be located in a region of the first extension tube 302 and attached to the tube by adhesion using an adhesive such as a glue or some other adhesive material. In one or more embodiments, at least one emitter is oriented to generate a shock wave outward from the longitudinal axis 301 of the catheter in the direction toward the inner surface of the encapsulation body and toward the lesion in the body lumen.

[0226] The catheters 300A-C shown in Figures 6A-6C and 7A-7C include at least three pairs of emitters (e.g., emitters arranged as a proximal pair, a central pair, and a distal emitter pair) located on separate elongation tubes, however such catheters may include any number of emitters placed within the inclusion and optionally located on the elongation tubes. In one or more embodiments, the emitters include more than three or fewer than three emitters, or more than six or fewer than six emitters. However, even larger numbers of emitters are also expected (e.g., eight emitters or ten emitters). Furthermore, as mentioned above, the catheter includes one or more further extension tubes (e.g., a second extension tube 304, a third extension tube 306, and / or a fourth extension tube 308) extending into one or more further encapsulations, and at least one further emitter may be located inside one or more further encapsulations and on one or more further extension tubes.

[0227] In various embodiments, the exemplary multi-balloon shock wave catheter 300A-C may include one or more further inclusions, such as a second inclusion 354, a third inclusion 356, and / or a fourth inclusion 358. For example, Figures 6A-6C and 7A-7C illustrate the distal end of an exemplary shock wave catheter including a first inclusion 352 and at least one further inclusion (e.g., a second inclusion 354, a third inclusion 356, and / or a fourth inclusion 358). The multiple inclusions of the catheter may be arranged so that when the catheter 300A-C is positioned in a body lumen, the first inclusion 352 and any further inclusions extend laterally to each other and abut against each other in the body lumen. Each of the inclusions 352, 354, 356, and 358 can be filled with a conductive fluid such that the inclusion expands and provides an annular channel between the inner surface of the inclusion and the emitter contained within it. When the first inclusion 352 and the further inclusions expand within the body lumen, at least a portion of the first inclusion (i.e., the first emitter-containing inclusion) comes into contact with the wall of the body lumen. The expansion of the further inclusions within the body lumen applies a force to the first inclusion 352, which pushes the first inclusion (and at least one emitter 322 within the first inclusion) toward the wall of the body lumen. Therefore, the relative expansion of the first inclusion body 352 and further inclusion bodies (e.g., a second inclusion body 354, a third inclusion body 356, a fourth inclusion body 358, and / or further inclusion bodies) can be used to modulate the distance between the emitter within the inclusion body and the lesion in the body lumen.

[0228] The catheter 300A-C may be configured such that, when the inclusions are inflated, at least one of the inclusions contacts a body lumen and / or an occluded area of ​​the body lumen. In some embodiments, the inclusions may be configured such that, when the inclusions are inflated, a channel is provided between two or more of the inclusions, maintaining a certain amount of fluid flow through the body lumen (e.g., maintaining a level of blood flow through the vessel in which the catheter is positioned). Advantageously, maintaining a certain amount of fluid flow through the body lumen can, for example, allow for longer duration shock wave therapy without the risk of ischemia. For example, when the inclusions are inflated, the fluid flow rate through the channel may be about 50% of the fluid flow rate through the body lumen when the catheter 600 is not positioned in the body lumen (i.e., the "normal flow rate"). In one or more embodiments, the fluid flow rate through the channel may be less than 50% of the normal flow rate, such as 10%, 15%, or 20% of the normal flow rate. In one or more embodiments, the fluid flow rate through the channel may exceed 50% of the normal flow rate, such as 70%, 80%, or 90% of the normal flow rate.

[0229] The volumes of the various inclusions in the catheter 300A-C may be separate from each other (i.e., not fluid-connected) so that the inclusions can be expanded and contracted independently, for example, by flowing conductive fluid into one or more of the inclusions using a fluid lumen extending within the inclusions. However, in other embodiments, one or more channels or orifices may allow fluid to flow between the inclusions so that the volumes of the inclusions are fluid-connected and the inclusions can be expanded together by flowing conductive fluid into a single inclusion. In one or more related embodiments, the multi-balloon catheter 300A-C may instead incorporate a single inclusion sealed in the extension tube and comprising multiple lobes, e.g., a two-lobe, three-lobe, or four-lobe configuration. In such embodiments, the expansion of the lobes of the inclusion can position the emitter within the inclusion closer to the lesion in the lumen. Optionally, the emitter is contained within two or more parts of a single inclusion, for example, located on two or more tubes extending within two or more parts of a single inclusion, or located at two axially spaced positions along a single extension tube.

[0230] The first inclusion 352 and further inclusions (e.g., a second inclusion 354, a third inclusion 356, a fourth inclusion 358, or further inclusions) may be independently filled with conductive fluid such that the degree of expansion of each inclusion can be independently controlled to position the desired emitter closer to the lesion in the body lumen. For example, to position the emitter in the first inclusion 352 closer to the emitter, the second inclusion 354 or further inclusions may be expanded with a relatively larger amount of conductive fluid to expand and push the first inclusion 354 and the emitter 322 contained therein closer to the body lumen.

[0231] To enable the independent inflation of each inclusion using a conductive fluid, in some embodiments, the extension tube of the catheter 300A-C provides multiple channels (i.e., one or more fluid lumens) for transporting the conductive fluid, with each of the multiple channels being for filling different inclusions using the conductive fluid. In such embodiments, each inclusion may be sealed in a region of the extension tube that fluidizes with at least one of the channels. For example, in some embodiments, the extension tube of the catheter includes a first channel for introducing conductive fluid into a first inclusion and a second channel for introducing conductive fluid into a second inclusion. However, any number of channels can be provided within the extension tube for filling any number of inclusions at the distal end of the catheter.

[0232] In addition, or alternatively, the exemplary catheter 300A-C includes two or more extension tubes (e.g., extension tube 302 and a second extension tube 304, a third extension tube 306, and / or a fourth extension tube 308, etc.), and each of the multiple inclusions may be sealed to a different extension tube, each providing an independent fluid lumen for introducing conductive fluid to inflate each of the individual inclusions. For example, the catheter 300A-C may include a first extension tube 302 and a second extension tube 304, offset from the longitudinal axis of the catheter. The first extension tube 302 may be sealed to a first inclusion 352 and configured to introduce fluid into the first inclusion, while the second extension tube 304 may be sealed to a second inclusion 354 and configured to introduce fluid into the second inclusion. In some embodiments, the first and / or further extension tubes extend outward from the central longitudinal axis of the catheter near the distal end of the catheter 300A-C before extending into one or more inclusions offset from the central longitudinal axis. In embodiments including a central inclusion and one or more peripheral inclusions, the central extension tube may extend into the central inclusion, and one or more peripheral extension tubes may extend into one or more of the peripheral inclusions. In embodiments without a central inclusion, the extension tube of the catheter may branch into multiple extension tubes near the distal end of the catheter before extending into inclusions. In some embodiments, the branched distal regions forming multiple extension tubes share one or more sides of the proximal region of the extension tubes (i.e., one or more of the lumens or channels of the extension tubes continue into the branched regions), and these sides extend into various inclusions at the distal end.

[0233] In some embodiments, at least one emitter is contained within one or more of the catheter's further inclusions. For example, a first inclusion 352 may surround a first emitter 322 of at least one emitter, while a second inclusion 354 surrounds a second emitter 324 of at least one emitter. A third inclusion 356 may surround a third emitter 326 of at least one emitter, and a fourth inclusion 358 or further inclusion may surround a fourth emitter 328 or further emitter of at least one emitter. Such a configuration is advantageous because it allows the multi-balloon shock wave catheter to generate shock waves in more than one of the inclusions, enabling the treatment of lesions located in various parts of the circumference of the body lumen. Like the first emitter 322 of the first inclusion body 352, the second emitter 324, the third emitter 326, the fourth emitter 328, and / or further emitters are located on the extension tube and can be moved closer to the lesion in the body lumen by controlling the relative expansion of the first inclusion body 352, the second inclusion body 354, the third inclusion body 356, the fourth inclusion body 358, and / or any further inclusion bodies. Similarly, the first, second, third, fourth, and further emitters may each consist of a single emitter or multiple emitters positioned within one or more of the first, second, third, fourth, and / or further inclusion bodies.

[0234] In some embodiments, at least one emitter is positioned on one or more extension tubes that extend into further (e.g., second, third, fourth, or further) inclusions of the catheter. For example, the first emitter 322 of the at least one emitter may be located on the first extension tube 302 extending into the first inclusion 352, and the second emitter 324 of the at least one emitter may be located on the second extension tube 304 extending into the second inclusion 354. The third emitter 326 of the at least one emitter may be mounted on the third extension tube 306 extending into the third inclusion 356, and the fourth emitter 328 of the at least one emitter may be mounted on the fourth extension tube 308 extending into the fourth inclusion 358. Additional configurations for positioning one or more emitters within multiple encapsulations of the catheter are also anticipated.

[0235] Figures 6A–6C illustrate the distal ends of various exemplary multi-balloon shock wave catheters, each having two, four, and multiple encapsulations, respectively. Figures 7A–7C provide cross-sections of the distal ends to show the encapsulation configurations of individual catheters.

[0236] Figures 6A and 7A illustrate the distal end of a first exemplary shock wave catheter 300A positioned within a body lumen. The exemplary catheter includes a first inclusion 352 and a second inclusion 354. The first inclusion 352 is sealed within a first extension tube 302 and surrounds at least one emitter 322. The first extension tube 302 extends into the first inclusion 352, and at least one emitter 322 is positioned on the first extension tube and configured to generate shock waves inside the first inclusion. In some embodiments, the first extension tube 302 includes a fluid lumen for inflating the first inclusion 352 using a conductive fluid. The second inclusion 354 does not surround any emitter. In some embodiments, the second encapsulation 354 is sealed into a second extension tube 304 which includes a separate fluid lumen for inflating the second encapsulation 354 using a conductive fluid.

[0237] As the distal end of the catheter 300A is advanced through the body lumen and positioned near the lesion within the body lumen, the first inclusion 352 and the second inclusion 354 are inflated using a conductive fluid, expanding the inclusions and allowing them to contact a portion of the body lumen. As shown in Figure 6A, once the catheter 300A is positioned within the body lumen, the second inclusion 354 extends laterally relative to the first inclusion 352 and abuts against it. Therefore, the expansion of the second inclusion applies force to the first inclusion, pushing it toward the wall of the body lumen. In the catheter shown in Figure 6A, the expansion of the second inclusion 354 while the catheter 300A is positioned in the body lumen causes at least one emitter 322 in the first inclusion 352 to move further away from the central longitudinal axis 301 and closer to one side of the body lumen than before the expansion.

[0238] Figure 7A provides a cross-sectional view of the first exemplary shock wave catheter 300A shown in Figure 6A. As seen in Figure 7A, expansion of the second inclusion 354 in the body lumen imparts force to the first inclusion 352, causing the first inclusion (and the extension tube 302 and emitter 322 contained therein) to move away from the longitudinal axis of the catheter 300 and toward the wall of the body lumen. Thus, a relatively larger expansion of the second inclusion 354 (and / or a relatively smaller expansion of the first inclusion 352) can position at least one emitter 322 further away from the central longitudinal axis and closer to the body lumen, while a relatively larger expansion of the first inclusion 352 (and / or a relatively smaller expansion of the second inclusion 354) can position at least one emitter 322 further away from the body lumen. A shock wave is generated in at least one emitter 322 within the first inclusion 352, allowing for selective treatment of a region of the body lumen adjacent to the first inclusion.

[0239] Figures 6B and 7B illustrate the distal end of a second exemplary shock wave catheter 300B positioned within a body lumen. The exemplary catheter 300B includes a first inclusion 352, a second inclusion 354, a third inclusion 356, and a fourth inclusion 358. Each of the first, second, third, and fourth inclusions surrounds at least one emitter, which is sealed in a separate extension tube and configured to generate shock waves within the inclusion. More specifically, the first encapsulation body 352 is sealed in a region of the first extension tube 302 and surrounds the first emitter 322; the second encapsulation body is sealed in a region of the second extension tube 304 and surrounds the second emitter 324; the third encapsulation body 356 is sealed in a region of the third extension tube 306 and surrounds the third emitter 326; and the fourth encapsulation body 358 is sealed in a region of the fourth extension tube 308 and surrounds the fourth emitter 328.

[0240] The first extension tube 302 extends into the first enclosure 352, and the first emitter 322 is mounted on the extension tube and configured to generate a shock wave inside the first enclosure. The second extension tube 304 extends into the second enclosure 354, and the second emitter 324 is mounted on the second extension tube and configured to generate a shock wave inside the second enclosure. The third extension tube 306 extends into the third enclosure 356, and the third emitter 326 is mounted on the third extension tube and configured to generate a shock wave inside the third enclosure. The fourth extension tube 308 extends into the fourth enclosure 358, and the fourth emitter 328 is mounted on the fourth extension tube and configured to generate a shock wave inside the fourth enclosure. Each of the first, second, third, and fourth extension tubes optionally includes a separate first, second, third, or fourth fluid lumen for independently inflating the individual first, second, third, and fourth inclusions using a conductive fluid.

[0241] As the distal end of the catheter 300B is advanced through the body lumen and positioned near the lesion within the body lumen, the first inclusion 352, the second inclusion 354, the third inclusion 356, and the fourth inclusion 358 are inflated using a conductive fluid, expanding the inclusions and allowing them to contact a portion of the body lumen. As shown in Figure 7B, once the catheter 300B is positioned within the body lumen, the first, second, third, and fourth inclusions extend laterally within the body lumen, contacting at least one adjacent inclusion; therefore, the expansion of one of the inclusions applies force to the adjacent inclusion, pushing it toward the wall of the body lumen. In the catheter 300B shown in Figure 7B, the expansion of any one of the inclusions while the catheter is positioned within the body lumen will move at least one emitter located within the other inclusions closer to the lesion.

[0242] Figure 7B provides a cross-sectional view of the second exemplary shock wave catheter 300C shown in Figure 6B. As seen in Figure 7B, expansion of any of the first, second, third, or fourth inclusions 352, second, third, or fourth inclusions 358 within the body lumen will impart force to the other inclusions, causing them to move away from the central longitudinal axis of the catheter 300C and toward the wall of the body lumen. For example, expanding the second inclusion 354 using a conductive fluid will cause the first, third, and fourth inclusions 352, third, and fourth inclusions 358 (and the extension tubes and emitters associated with each individual inclusion) to move away from the longitudinal axis of the catheter 300C and toward the wall of the body lumen. Therefore, a relatively larger dilation of one or more of the inclusion bodies (and / or a relatively smaller dilation of some other inclusion bodies) can position at least one emitter contained within the less dilated inclusion body closer to the body lumen. After the inclusion bodies have been dilated to the desired amount to position one or more of the emitters closer to the lesion in the body lumen, a shock wave can be generated at the emitter to selectively treat the area of ​​the body lumen adjacent to the emitter.

[0243] Figures 6C and 7C illustrate the distal end of a third exemplary shock wave catheter 300, positioned within a body lumen. The exemplary catheter 300C includes a first inclusion 352 configured as a central inclusion and at least one further inclusion configured as a peripheral inclusion. In some embodiments, the catheter 300C includes a single peripheral inclusion. However, as shown in Figure 6C, the catheter 300C may include multiple peripheral inclusions positioned adjacent to and periphery of the central inclusion. In various embodiments, the catheter 300C may include four, five, six, seven, eight, or more than eight peripheral inclusions adjacent to and abutting the central inclusion of the catheter when the catheter is positioned within a body lumen and the inclusions are inflated. Each peripheral inclusion surrounds at least one emitter, which is sealed to the extension tube and configured to generate shock waves within the individual inclusions of the multiple peripheral inclusions. Each extension tube extends into individual encapsulations of multiple peripheral encapsulations and optionally includes a fluid lumen for independently inflating multiple individual encapsulations using a conductive fluid. As shown in Figure 6C, in some embodiments, the central encapsulation does not include an emitter.

[0244] As the distal end of catheter 300C is advanced through the body lumen and positioned near the lesion within the body lumen, the central and peripheral inclusions are inflated using conductive fluid, expanding the inclusions and positioning the peripheral inclusions to contact a portion of the body lumen. As shown in Figure 6C, once catheter 300C is positioned within the body lumen, the peripheral inclusions extend laterally relative to the central inclusion and abut against it; therefore, the expansion of the central inclusion applies force to the peripheral inclusions, pushing them toward the wall of the body lumen. In catheter 300C shown in Figure 7C, the expansion of the central inclusion while the catheter is positioned within the body lumen will move the emitters located within all peripheral inclusions closer to the lesion within the body lumen. A relatively larger expansion of any of the peripheral inclusions may move the emitters located within other, smaller expanding peripheral inclusions closer to the lesion within the body lumen.

[0245] Figure 7C provides a cross-sectional view of a third exemplary shock wave catheter 300C shown in Figure 6C. As seen in Figure 7C, expansion of the central inclusion will impart an outward force over each of the peripheral inclusions, moving the inclusions (and the extension tubes and emitters associated with each of the individual inclusions) away from the longitudinal axis of the catheter 300C and toward the wall of the body lumen. Relative expansion of the peripheral inclusions may also be used to modulate the distance between various emitters and the wall of the body lumen. For example, expanding a peripheral inclusion closest to one side of the body lumen may move a peripheral inclusion (and the extension tubes and emitters associated with the inclusions) closest to the opposite side of the body lumen closer to the opposite side of the body lumen. Therefore, a relatively larger dilation of one or more peripheral inclusions on one side of the body lumen (and / or a relatively smaller dilation of peripheral inclusions on the opposite side of the body lumen) can position at least one emitter contained within the less dilated inclusion closer to the body lumen. After the inclusions are dilated to the desired amount to position one or more of the emitters closer to the lesion in the body lumen, a shock wave can be generated at the emitter to selectively treat the area of ​​the body lumen adjacent to the emitter.

[0246] As shown in Figures 6A-6C and 7A-7C, each emitter is enclosed within an inclusion body, and optionally, at least three pairs of emitters are located on the extension tube within the inclusion body. However, this is provided for illustrative purposes only, and the catheter may include a single emitter in one or more of the inclusion bodies, two emitters in one or more of the inclusion bodies, four emitters in one or more of the inclusion bodies, six emitters in one or more of the inclusion bodies, or more than six emitters in one or more of the inclusion bodies. In other embodiments, the catheter may include different numbers of emitters in different inclusion bodies (e.g., one pair of emitters in a first inclusion body and two pairs of emitters in a second inclusion body). In some embodiments, each peripheral inclusion body may include one or more emitters, as shown in Figure 7C. In other embodiments, the emitter may be supplied only to selected peripheral inclusions, such as alternating peripheral inclusions or peripheral inclusions along one circumferential side of the catheter, so that the sound wave output from the emitter is concentrated on one side. In some embodiments, power is supplied to the emitter in each inclusion by using one or more conductive wires (e.g., insulated copper wires) or optical fibers that are electrically or optically connected to at least one of the emitters inside each emitter-containing inclusion. The conductive wires or optical fibers may extend along at least a portion of the extension tube. For example, the conductive wires or optical fibers may extend through a wire lumen contained within the extension tube.

[0247] In some embodiments, one or more emitters are connected in series, and therefore, power supplied by a power source generates a shock wave in each of the series-connected emitters as, for example, current flows across the spark gap between the individual electrodes of the series-connected emitters. For example, emitters contained within a single inclusion of a catheter may be connected in series, and therefore, all emitters within a particular inclusion can be emitted together by applying a voltage pulse across the emitters. The emitters may be connected in series in a particular order that is advantageous for shock wave therapy. For example, in some embodiments, a voltage pulse from a voltage source first causes current to flow through the emitters in the more distal region of the inclusion to treat the more distal portion of the lesion in the body lumen, and then causes current to flow through the emitters in the more proximal region of the inclusion to treat the more proximal portion of the lesion in the body lumen.

[0248] In another embodiment, one or more emitters may be wired on a separate circuit or separate circuit branch so that power is selectively supplied to only a desired subset of the emitters, and shock waves can be generated in the desired subset. For example, in one embodiment, emitters contained in each of the individual inclusions may be wired on a separate circuit or circuit branch from emitters contained in different inclusions so that shock waves can be selectively generated in a particular inclusion of the catheter to selectively treat, for example, a region of the body lumen adjacent to one of the first, second, third, fourth, or further inclusions. During shock wave therapy, the user may first generate a shock wave in the first inclusion to treat a region of the body lumen adjacent to the first inclusion, and then continue to treat additional regions of the body lumen by generating shock waves in the second, third, fourth, or further inclusions. Additional or alternative wiring of emitters is also anticipated.

[0249] In some embodiments, it may be advantageous to rotate the distal end of the catheter 300 in its original position to position one or more of the emitters closer to the lesion in the body lumen. For example, as shown in Figure 7A, in some embodiments, the emitters are arranged such that the expansion of various inclusions moves the emitters closer to only a portion of the body lumen wall (e.g., only a specific side of the lumen). In such embodiments, during use, the physician may sequentially treat portions of the body lumen by rotating the extension tube, rotating the inclusions within the body lumen, and positioning at least one emitter closer to a new portion of the body lumen wall. For example, the physician may incrementally rotate the extension tube clockwise to treat the entire circumference of the body lumen.

[0250] Figure 8 illustrates an embodiment of a shock wave catheter 400, which includes one or more emitters 422 positioned on the inner surface of an inclusion body 452 near the distal tip of the catheter, such that the expansion of the inclusion body while the catheter is positioned in a body lumen moves at least one emitter further away from the central axis 401 and closer to the wall of the body lumen. Catheter 400 is an embodiment of catheter 100 in Figure 1. Once catheter 400 has advanced through a body lumen and is positioned close to a lesion in the body lumen, the inclusion body 452 is expanded using a conductive fluid to contact the body lumen and position at least one emitter 422 close to the lesion in the body lumen. After the inclusion body 452 has expanded, one or more shock waves can be generated at at least one emitter 422 to treat the lesion. Once the shock wave therapy is complete, the inclusion body 452 is reduced, and the distal end of the catheter 400 can be removed from the body lumen.

[0251] An exemplary catheter 400 includes an extension tube 402 defining the central longitudinal axis 401 of the catheter. An inclusion body 452, having a distal end 454 and a proximal end 456, is sealed in a region of the extension tube 402 surrounding at least one emitter 422 and is fillable with a conductive fluid, forming an annular channel around the extension tube where at least one emitter can generate shock waves in the conductive fluid. When inflated, the inclusion body 452 expands, filling a space in a body lumen and contacting the wall of the body lumen containing the lesion. The inclusion body 452 may be an angioplasty balloon configured to inflate to a certain diameter as described above. In some embodiments, the material of the inclusion body is configured to be thicker and / or to inflate in a relatively smaller amount than a conventional angioplasty balloon.

[0252] The incubator 452 surrounds at least one emitter 422, which is positioned on the inner surface of the incubator and configured to generate a shock wave inside the incubator when a voltage is applied to at least one emitter. Optionally, at least one emitter 422 is attached to the inner surface of the incubator 452 by adhesive, such as a glue or some other adhesive material. Such a catheter 400 may include any number of emitters positioned on the inner surface of the inflatable incubator. In one or more embodiments, the emitter 422 includes more than two or less than two emitters, or more than six or less than six emitters. However, even larger numbers of emitters are also expected. For example, as seen in Figure 8, at least one emitter 422 includes multiple emitters (e.g., 10 emitters). As described above, each emitter includes at least one electrode pair, the electrodes of each pair may be spaced apart from each other to form a spark gap between the electrodes. However, in alternative embodiments, the emitters may each be formed by the distal end of the optical fiber.

[0253] As shown in Figure 8, the emitters 422 are positioned on the inner surface of the inclusion body 452. In some embodiments, the emitters 422 are arranged substantially evenly across the surface of the inclusion body, for example, the emitters may be arranged on the inner surface of the inclusion body 452 in a spiral pattern or a grid pattern. However, the emitters 422 may be arranged on the inner surface of the inclusion body 452 in any desired pattern. In other embodiments, the emitters 422 may be arranged with more or fewer emitters on a particular side of the inclusion body 452, i.e., to selectively target a certain area of ​​the body lumen. In another embodiment, a larger number of emitters may be positioned toward the distal end of the inclusion body 452, which may prevent the advancement of the entire width of the inclusion body through the lesion and body lumen, and may facilitate the treatment of other lesions that are more effectively treated by shock waves through the distal end of the inclusion body. Additional arrangements of emitters are also anticipated.

[0254] When a shock wave is generated from the emitter 422, the shock wave can propagate substantially outward (i.e., outward with respect to the central longitudinal axis of the catheter 400). In one or more embodiments, at least one emitter 422 is oriented to generate a shock wave outward from the longitudinal axis of the catheter 400 in a direction toward the inner surface of the inclusion body 452 and toward the lesion in the body lumen. In another embodiment, to minimize the risk of rupturing the inclusion body 452 during shock wave generation, the emitter 422 may be arranged to propagate the shock wave in a direction substantially perpendicular to the inner wall of the inclusion body 452 (for example, with one or more forward-emitting emitters) or toward the longitudinal axis of the catheter 400. Alternatively, or in addition, the emitter 422 may be oriented to generate shock waves outward from the extension tube 402 in various directions, for example, with one or more forward-emitting emitters, one or more outward-emitting emitters, and / or one or more emitters emitting perpendicular to the inner wall of the encapsulation body 452. In some embodiments, a relatively lower power is applied to the emitter 422 on the surface of the encapsulation body 452 to produce relatively smaller shock waves that are less likely to rupture the material of the encapsulation body.

[0255] In some embodiments, the shock wave generating region of one or more of the emitters 422 (e.g., the spark gap between pairs of electrodes of the emitter) is maintained at a certain distance from the surface of the containment 452. As mentioned above, positioning the emitters 422 close to the walls of the containment 452 may pose a risk of rupturing the containment when a shock wave is emitted from the emitters 422 in close proximity to the material of the containment. Therefore, in some embodiments, the spark gap of at least one of the emitters is at least 1 / 10 of a millimeter (0.1 mm) away from the inner surface of the containment, at least 1 / 15 of a millimeter (0.15 mm) away from the inner surface of the containment, at least 1 / 5 of a millimeter (0.2 mm) away from the inner surface of the containment, at least 1 / 4 of a millimeter (0.25 mm) away from the inner surface of the containment, or at least 1 / 2 of a millimeter (0.5 mm) away from the inner surface of the containment.

[0256] To further reduce the risk of rupturing the wall of the containment 452, in some embodiments, one or more of the emitters 422 are spaced away from the inner wall of the balloon using one or more spacers 429. Beneficially, the spacers 429 may maintain the spark gap of the emitter 422 so that, typically, a voltage applied across the emitter prevents a shock wave from rupturing the containment 452. In various embodiments, the spacers 429 may be configured to maintain the spark gap of the emitter so as to be at least 1 / 10th of a millimeter (0.1 mm) away from the inner surface of the containment, at least 1 / 15th of a millimeter (0.15 mm) away from the inner surface of the containment, at least 1 / 5th of a millimeter (0.2 mm) away from the inner surface of the containment, at least 1 / 4th of a millimeter (0.25 mm) away from the inner surface of the containment, or at least 1 / 2th of a millimeter (0.5 mm) away from the inner surface of the containment. For example, the spacer 429 may have a height of at least 1 / 10th of a millimeter (0.1 mm), at least 1 / 5th of a millimeter (0.2 mm), at least 1 / 4th of a millimeter (0.25 mm), or at least 1 / 2th of a millimeter (0.5 mm). In some embodiments, the spacer may be molded into a cylindrical shape. The spacer 429 may be positioned between the emitter 422 and the wall of the inclusion body 452 and may optionally be attached to the emitter and / or balloon using an adhesive. The spacer 429 may be configured to orient the emitter 422 in a desired direction with respect to the central longitudinal axis 401 of the wall of the catheter 400 and / or inclusion body (for example, to position the emitter so that they are fired toward the inner surface of the balloon and toward a lesion in the lumen of the body).

[0257] The emitter 422 of the catheter 400 can be connected to a power source (e.g., a pulsed voltage source) such as a power supply 28 for supplying power to the emitter 422 within the encapsulation body 452 and generating shock waves. In some embodiments, power is supplied to the emitter 422 using one or more conductive wires (e.g., insulated copper wires) extending between the power supply and at least one emitter located on the inner surface of the encapsulation body. For example, in some embodiments, a first wire 432 and a second wire 434 extend along at least a portion of the extension tube 402 and provide electrical connections to various emitters 422 mounted on the inner surface of the encapsulation body 452. In some embodiments, one or more of the wires 432, 434 extend through a wire lumen inside the extension tube 402 or within a channel or protrusion extending along the outside of the extension tube. In some embodiments, wires 432, 434 may extend beyond the distal end of the extension tube into the inclusion and be electrically connected to at least one of the emitters. In some embodiments, wires 432, 434 extend along at least a portion of the inner surface of the inclusion 452 (e.g., along the inner surface between each of the electrodes positioned on the inner surface). In some embodiments, wires 432, 434 are fixed or bonded to the surface of the inclusion 452 at one or more points. The conductive wires 432, 434 may optionally include some degree of flexure in the portion of the wire inside the inclusion 452 so that the wire can bend and conform during the expansion of the inclusion without providing physical resistance that would impede the expansion of the inclusion. When the inclusion 452 is in a retracted state, for example, during the insertion and advancement of the catheter 400, wires 432, 434 may fold within the inclusion 452. However, in other embodiments, as shown in Figure 8, the conductive wires 432, 434 extend freely within the encapsulation 452 between one or more emitters 422 and are not adhered to or fixed to the inner surface of the encapsulation. In other embodiments, laser energy may be used to generate a shock wave, and power may be supplied to the emitter 422 through optical fibers configured similarly to the wires 432, 434.

[0258] In some embodiments, the emitters 422 are connected in series, and as current flows across each spark gap between the electrodes of the emitters, the power supplied by the power source (e.g., a voltage pulse) generates a shock wave in each of the emitters within the inclusion 452. The emitters 422 may be connected in an order that is more convenient for shock wave therapy (for example, in order to treat a more distal portion of a lesion in a body lumen, the current flows first through the more distal emitters, generating a shock wave in the more distal portion of the inclusion).

[0259] In another embodiment, one or more of the emitters 422 may be wired on a separate circuit or circuit branch so that a voltage pulse can be selectively applied only to a desired subset of the emitters. For example, distal groupings of emitters, central groupings of emitters, and / or proximal groupings of emitters may be wired in a separate circuit or branch (with the emitters in each grouping wired in series and configured to emit together) so that shock waves can be selectively generated on any of the individual distal, central, and proximal groupings of emitters. In another embodiment, emitters attached to various parts or sides of an inclusion may be wired in a separate circuit or branch so that shock waves can be selectively generated on a certain side of the inclusion, i.e., to treat a non-concentric lesion located on a specific side of a body lumen. Additional or alternative wiring of emitters is also conceivable.

[0260] One or more of the inclusions in the catheter described above may, individually or collectively, have an expanded diameter approximately equal to the diameter of the body lumen (i.e., the diameter of the body lumen, or a smaller diameter representing the diameter when partially occluded by a lesion) when inflated. In various embodiments, the inclusions in the expanded state may have expanded diameters of at least 4 mm, at least 5 mm, at least 8 mm, at least 10 mm, or greater than 20 mm. In more specific embodiments, the inclusions may have expanded diameters of 9 mm to 12 mm or 20 mm to 25 mm. However, the exemplary catheter may include one or more inclusions configured to expand to any expanded diameter. In some embodiments, the catheter comprises two or more inclusions, each inclusion having a certain expansion diameter, for example, a central inclusion having a larger diameter than one or more peripheral inclusions, or a first inclusion having a larger diameter than a second inclusion.

[0261] The inclusion body may be formed from an elastomerous material so that it can be repeatedly inflated and deflated without damaging or deforming the balloon material. For example, the inclusion body can be formed from a polymer material. In some embodiments, the inclusion body comprises one or more inflatable angioplasty balloons. However, in other embodiments, the inclusion body is formed from a relatively more rigid material or has a relatively larger wall thickness so that the inclusion body inflates in a relatively smaller amount than conventional angioplasty balloons. In another aspect, the inclusion body may be formed from a thicker material than the material of conventional angioplasty balloons. In some embodiments, the inclusion body is configured so that when it is inflated, it comes into contact with the body lumen and / or the occluded area of ​​the body lumen. However, in other embodiments, for example, multi-balloon embodiments, the inclusion body may be inflated to a relatively smaller diameter (i.e., inflated to less than the fully inflated state) so that the combined inflation of the multiple inclusion bodies causes more than one inclusion body to come into contact with the surface of the body lumen and / or the lesion. In other embodiments of the multi-inclusion catheter, one or more of the inclusions may be made from a different material and / or have a different wall thickness from the other inclusions in order to allow the inclusions to expand to different sizes.

[0262] In some embodiments, the insulator is configured to tolerate an inflation pressure of up to approximately 4 atmospheres (4 atm) (i.e., formed from a flexible material that allows the insulator to inflate to 4 atmospheres (4 atm) without rupturing or deforming the balloon material). In one or more embodiments, the insulator may be sufficiently flexible to tolerate inflation pressures exceeding 4 atmospheres (4 atm), such as an inflation pressure of up to 6 atmospheres (6 atm) or up to 10 atmospheres (10 atm).

[0263] The inclusion body may be configured to take on a circular shape (when viewed from a cross-sectional perspective) while being inflated. However, in other embodiments, the inclusion body may be configured to take on an elliptical shape or any other preferred shape. In embodiments including multiple inclusion bodies (see, for example, Figures 6A-6C and 7A-7C), the shape of the first inclusion body may be compressed by the inflation of a second or further inclusion body adjacent to and / or in contact with the first inclusion body. Similarly, the position of the first inclusion body within the body lumen may be moved (e.g., pushed outward from the central longitudinal axis of the catheter) by the inflation of a second or further inclusion body adjacent to and / or in contact with the first inclusion body.

[0264] The inclusion body surrounds an emitter assembly, which includes at least one emitter configured to generate shock waves inside the inclusion body to treat lesions in the body lumen. As will be described in more detail with reference to Figures 2A-2B, 3A-3B, 4A-4B, 5A-5C, 6A-6C, 7A-7C, and 8, at least one emitter is configured to move outward relative to the longitudinal axis of the stretcher tube 12 to a position closer to the inner surface of the balloon and / or the lesion in the body lumen. In some embodiments, the emitter is configured to expand outward by at least 1 mm, at least 2 mm, at least 3 mm, at least 4 mm, or at least 5 mm from the central longitudinal axis of the catheter 100 (i.e., the central longitudinal axis of the stretcher tube 12 of the catheter). However, in other embodiments, the emitter is configured to expand even further, for example, at least 1 cm from the central longitudinal axis of the catheter.

[0265] A cross-section of an exemplary extension tube 30 is illustrated in Figure 9. The extension tube 30 includes at least one fluid lumen 32 for introducing conductive fluid into an inclusion at the distal end of the catheter. In some embodiments, as shown in Figure 9, the extension tube 30 may include at least a second fluid lumen 33 for introducing conductive fluid into a second or further inclusion at the distal end of the catheter. The extension tube 30 also includes one or more wire lumens, channels, or external grooves for carrying conductive wires or optical fibers that supply power from an external power source, for example, voltage pulses from an endovascular lithotripsy (IVL) generator 28 shown in Figure 1, to one or more emitters in the inclusion at the distal end of the catheter. For example, the extension tube 30 includes a first wire lumen 34 for carrying a first wire and a second wire lumen 35 for carrying a second wire (or, in an alternative embodiment, a first optical fiber and a second optical fiber). In addition, or alternatively, the extension tube 30 may include one or more channels or external grooves on the outer edge of the extension tube, and one or more wires (or optical fibers) extend within the channel between the external power source and the emitter. In some aspects, the extension member optionally extends through the central lumen 36 of the extension tube 30, extending along the longitudinal axis of the extension tube 30, and the extension member is used to actuate an expandable support structure to position one or more emitters closer to a lesion (for example, by moving the extension member in a proximal or distal direction relative to the extension tube). The extension tube 30 also optionally includes a guidewire lumen for receiving a guidewire to facilitate the insertion and advancement of a catheter through a body lumen. The extension tube has a diameter d that can be, for example, less than 1 millimeter (1 mm), 1 millimeter (1 mm) to 2 millimeters (2 mm) to 3 millimeters (3 mm), 3 millimeters (3 mm) to 4 millimeters (4 mm), or greater than 4 millimeters (4 mm).

[0266] The stretching tube 30 in Figure 9 may be used as the stretching tube for any of the catheters shown in Figures 2A-2B, 3A-3B, 4A-4B, 5A-5C, 6A-6C, 7A-7C, and 8. The specific channels, lumens, and other aspects of the stretching tube may vary when applied to the specific exemplary catheters described herein. For example, the stretching tubes used in the catheters of Figures 2A-2B, 3A-3B, 4A-4B, 5A-5C, 6A-6C, 7A-7C, and 8 may contain more or fewer channels and lumens than the stretching tube. For example, some exemplary catheters may lack a guidewire lumen, or lack a wire lumen or fluid lumen. Alternatively, any of the channels and lumens of the stretching tube may be located outside the stretching tube (e.g., within a side tube or channel on the outer surface of the stretching tube). Furthermore, a channel or lumen may be combined to serve two purposes, for example, the lumen may be configured to receive both a guidewire and an extension member, or the lumen may be configured to transport the wire and allow a conductive fluid to flow within the enclosure.

[0267] In multi-balloon embodiments of a catheter (e.g., the exemplary catheters shown in Figures 6A-6C and 7A-7C), the stretching tube may include a number of fluid lumens equal to the number of inclusions of the catheter, each fluid lumen configured to enter and inflate an individual inclusion of the catheter. In addition, or alternatively, some exemplary catheters may include two or more stretching tubes (e.g., a first stretching tube and a second stretching tube, or a stretching tube and a side tube), each tube extending into a different inclusion of the catheter. In such embodiments, the features of the stretching tube may be divided or duplicated between the various stretching tubes and / or side tubes, providing parallel fluid lumens, wire lumens, and other features to the various inclusions. In further embodiments, the stretching tube of the catheter may branch near the distal end of the catheter and extend into two or more inclusions at the distal end of the catheter. In such embodiments, the distal end of the stretching tube may be configured as two or more stretching tubes. Therefore, the extension tube in Figure 9 is provided simply as an example, and other extension tubes described herein may incorporate more, fewer, or different features than the extension tube.

[0268] In some embodiments, the shock wave catheter includes a shock wave emitter assembly having one or more emitters on an adjustable support structure, such that the longitudinal spacing (i.e., spacing along the longitudinal axis of the catheter) or circumferential spacing (i.e., spacing around the central longitudinal axis of the catheter) is adjustable by adjusting the support structure (e.g., by crushing or expanding the support structure) to optimize the interference pattern of shock waves generated by one or more emitters. For example, the longitudinal spacing of two adjacent emitters may be adjusted to less than about 4 millimeters (4 mm), allowing the shock waves generated from the two emitters to interfere substantially constructively and impart more force to the occlusion than would be possible from non-interfering waves from the same emitters. The same catheter may also be used to treat another occlusion requiring less force by adjusting the longitudinal spacing to reduce the amount of constructive interference. Endovascular lithotripsy using interfering shock waves is described in detail in U.S. Patent Application No. 17 / 967,544 (the full contents of which are incorporated herein by reference).

[0269] Figure 10 illustrates an exemplary method for treating a lesion in a body lumen. This method can be used in conjunction with a catheter, which includes an expandable support structure such as one of the catheters shown in Figures 2A-2B, 3A-3B, and 4A-4C described above.

[0270] Step 1001 of Method 1000 includes advancing the catheter within a body lumen to a position close to the lesion. In some embodiments, the inclusion is folded when the catheter is advanced through the body lumen. In some embodiments, the diameter of the support structure is less than 1 mm, less than 2 mm, less than 3 mm, less than 4 mm, or less than 5 mm when the catheter is advanced through the body lumen. In some embodiments, the diameter of the support structure is 1 mm to 2 mm, 2 mm to 4 mm, or 4 mm to 6 mm when the catheter is advanced through the body lumen. Step 1002 of Method 1000 includes inflating the catheter inclusion so that the outer surface of the inclusion is in contact with the body lumen.

[0271] Step 1003 includes expanding the support structure inside the inclusion body to position at least one emitter located on the support structure further away from the central longitudinal axis of the catheter and / or closer to the body lumen. In some embodiments, the step of expanding the support structure includes expanding the support structure to a diameter of 8 mm to 12 mm. In some embodiments, the step of expanding the support structure includes expanding the support structure to a diameter of more than 1 cm. In some embodiments, the step of expanding the support structure moves the first emitter outward from the longitudinal axis of the catheter in a first direction and the second emitter outward from the longitudinal axis in a second direction. In some embodiments, the first direction is opposite to the second direction. In some embodiments, the support structure comprises a first stop and a second stop, which are spaced apart in the compressed state of the support structure and come into contact in the expanded state of the support structure, and the step of expanding the support structure includes moving the second stop toward the first stop. In some embodiments, the step of expanding the support structure includes moving an extension member in a proximal or distal direction, the extension member extending between the first stop and the second stop and operably coupled to at least one of them. In some embodiments, the step of expanding the support structure includes pulling a wire, which is operably coupled to at least one of the first stop and the second stop. In some embodiments, the extension member comprises a first tube and a second tube surrounding at least a portion of the first tube, and the movement of the second tube relative to the first tube causes the support structure to expand.

[0272] Step 1004 includes the step of supplying power to at least one emitter (for example, by applying a voltage across the electrode pair of at least one emitter) to generate one or more shock waves inside the inclusion to treat the lesion. In some embodiments, the method further includes the step of rotating the support structure to position at least one emitter closer to the lesion in the body lumen.

[0273] Figure 11 illustrates another exemplary method 1100 for treating an obstruction in a body lumen. This method can be applied to a catheter containing multiple inclusions, such as one of the multi-balloon catheters shown in Figures 6A-6C and 7A-7C described above. In step 1101, method 1100 includes advancing the catheter in a body lumen to a position close to the lesion. In some embodiments, the first and second inclusions are folded when the catheter is advanced through the body lumen. In step 1102, method 1100 includes inflating the first inclusion of the catheter, which surrounds the first emitter.

[0274] In step 1103, method 1100 includes the step of inflating a second inclusion of the catheter, the step of inflating the second inclusion while the catheter is positioned in a body lumen, moves the first emitter closer to the lesion in the body lumen. In some embodiments, the steps of inflating the first and second inclusions include the step of filling the inclusions with a conductive fluid. In some embodiments, the step of inflating the first inclusion includes the step of filling the first inclusion with a conductive fluid through a first fluid lumen, and the step of inflating the second inclusion includes the step of filling the second inclusion with a conductive fluid through a second fluid lumen.

[0275] In step 1104, method 1100 includes the step of applying a voltage to a first emitter to generate one or more shock waves inside the first inclusion to treat a lesion. In some embodiments, a second inclusion surrounds a second emitter, and the method further includes the step of applying a voltage to the second emitter to generate one or more shock waves inside the second inclusion. In some embodiments, the method includes the step of inflating a third inclusion of the catheter, and the step of inflating the third inclusion while the catheter is positioned in a body lumen moves the first emitter closer to the lesion in the body lumen. In some embodiments, a third inclusion surrounds a third emitter, and the method further includes the step of applying a voltage to the third emitter to generate one or more shock waves inside the third inclusion.

[0276] In some embodiments, the method further includes the step of rotating the first and second inclusions around the longitudinal axis of the catheter to move the first emitter closer to the lesion in the body lumen.

[0277] Figure 12 illustrates another exemplary method 1200 using a shock wave catheter. Method 1200 can be applied to a catheter having emitters positioned on the inner surface of a catheter encapsulation, such as the catheter shown in Figure 8, as described above. Step 1201 includes advancing the catheter in a body lumen to a position close to a lesion. Step 1202 includes inflating the catheter encapsulation so that the multiple emitters positioned on the inner surface of the encapsulation move closer to the lesion in the body lumen. Step 1203 includes supplying power to the multiple emitters (e.g., by applying a voltage) to generate one or more shock waves to treat the lesion.

[0278] Figure 13 illustrates another exemplary method 1300 of using a shock wave catheter. In this method, a single catheter (e.g., any of the catheters described above) having an emitter assembly with one or more emitters is used to treat a plurality of lesions within a patient's body. Step 1301 includes advancing the catheter within a body lumen to a first location proximate to a first lesion. The catheter has an enclosure at its distal end and an expandable emitter assembly within the enclosure having a collapse diameter in a collapsed configuration. One or more emitters of the emitter assembly may be located on a laterally expandable support structure within a plurality of enclosures or adhered to the inner wall of an enclosure as described above. Step 1302 includes expanding the enclosure at the distal end of the catheter. Step 1303 includes laterally expanding the support structure such that the support structure has an expanded first diameter. Step 1304 includes generating one or more shock waves to treat the first lesion. Step 1305 includes collapsing the emitter assembly and reducing the enclosure. Step 1306 includes advancing the catheter within the body lumen to a second location proximate to a second lesion. Step 1307 includes expanding the enclosure at the distal end of the catheter. Step 1308 includes laterally expanding the support structure such that the emitter assembly has a second expanded diameter different from the first diameter. Step 1309 includes generating one or more shock waves to treat the second lesion.

[0279] In an alternative implementation of method 1300, one of steps 1303 and 1308 is an optional step such that the support structure is not expanded prior to generating the shock waves in steps 1304 and 1309. The method may be implemented to accommodate relatively smaller sized blood vessels at the first or second location.

[0280] Figures 14A and 14B illustrate another exemplary shock wave catheter 1400 having a flexible ribbon 1401 in its distal region surrounded by an inclusion 1450 that can be filled with fluid. In one or more embodiments, the inclusion 1450 is an angioplasty balloon. In various embodiments, at least one shock wave emitting region (e.g., regions 1411, 1413, 1415) is mounted on the ribbon and configured to generate shock waves (e.g., by electric wire or optical fiber) when powered (e.g., by voltage application or laser). In other words, the ribbon may be a support structure for at least one shock wave emitting region. In one or more embodiments, at least one shock wave emitting region includes an electrode pair as described above. In some embodiments, at least one shock wave emitting region includes one or more light emitting regions (e.g., unclad regions) of an optical fiber or optical fiber bundle. The ribbon 1401 may be connected proximal to an extension tube similar to the extension tube described above.

[0281] FIG. 14A illustrates a first configuration of a catheter 1400 that allows for a thinner outer profile when the ribbon 1401 is substantially linear (e.g., substantially unwound) and the catheter is navigated to a target lesion. FIG. 14B illustrates a second embodiment of the catheter 1400 in which the ribbon 1401 is wound in a spiral and substantially centered about the central longitudinal axis 1420 of the enclosure 1450. In this second configuration, one or more of the shock wave emission regions 1411, 1413, 1415 are further lateral from the central longitudinal axis 1420 than in the unwound configuration. In one or more embodiments, the enclosure is filled to a pressure of about 2 atmospheres (2 atm) to about 6 atmospheres (6 atm) in the second configuration. In one or more embodiments, the enclosure is filled to a pressure of about 1 atmosphere (1 atm) to about 4 atmospheres (4 atm) in the second configuration. In one or more embodiments, the enclosure is filled to a pressure of about 1 atmosphere (1 atm) to about 6 atmospheres (6 atm) in the second configuration. In one or more embodiments, at least one of the shock wave emission regions is more than 1 millimeter (1 mm) away from the central longitudinal axis in the second configuration. In one or more embodiments, at least one of the shock wave emission regions is about 3 millimeters (3 mm) to about 6 millimeters (6 mm) away from the central longitudinal axis (e.g., the longitudinal axis of the balloon of the catheter) in the second configuration. In one or more embodiments, at least one of the shock wave emission regions is closer to the wall of the enclosure than the central longitudinal axis in the second configuration. In one embodiment, at least one shock wave generation region is more than 1 millimeter (1 mm) away from the wall of the enclosure in the second configuration. In some embodiments, at least one emitter is less than 1 millimeter (1 mm) away from the wall of the enclosure in the second configuration.

[0282] According to one embodiment, the position of one or more shock wave generating regions is adjusted by rotating the ribbon about a central longitudinal axis. This can be accomplished by rotating a ribbon or extension tube attached to the tube at a location closer to the catheter. For example, the support structure may be connected to a rotatable proximal handle. Rotation of the proximal handle can change the ribbon from a first configuration to a second configuration.

[0283] In some embodiments, the ribbon 1401 may be formed from a shape memory material (e.g., nitinol) or an elastic material (e.g., an elastic polymer) that substantially unwinds when the inclusion body 1450 is not filled with fluid, such that at least one shock wave generating region is close to the central axis of the inclusion body 1450. When the inclusion body 1450 is filled with fluid, the ribbon 1401 may be configured to become more wound up so that at least one shock wave generating region moves laterally away from the central axis of the inclusion body 1450. In embodiments in which the ribbon 1401 is made from a shape memory material, the ribbon may automatically become wound up in response to environmental stimuli (e.g., changes in temperature, pH, or pressure) when the distal region is positioned at the treatment site and the inclusion body is filled with fluid. In some embodiments, the ribbon 1401 may be elastically wound up in response to the expansion of the encapsulation body 1450 (when filled with fluid), causing at least one shock wave generating region to move laterally outward.

[0284] Figures 15A–15D illustrate the distal region of another exemplary shock wave catheter 1500 having one or more movable shock wave emitting regions 1511, 1513. The catheter 1500 includes one or more angled ports (e.g., ports 1531, 1533) branching from the outer tube 1502. Each port is associated with a shock wave generating region (e.g., shock wave generating regions 1511, 1513). As shown in Figures 15A and 15B, the shock wave generating regions may be at least partially housed within the angled ports, which allows for a narrower profile when the catheter is being navigated to a target lesion. In one or more embodiments, at least one shock wave generating region is connected to a hinged region 1543, which may be formed from an elastic material, which can improve maneuverability and further reduce the catheter's profile. The shock wave generating regions 1511, 1513 each branch from an inner extension member 1541.

[0285] As shown in Figures 15C and 15D, at the site of treatment, the inclusion body (e.g., an angioplasty balloon) may be inflated, and the shock wave generating regions 1511, 1513 (e.g., shock wave generating emitters) (housed within the inclusion body) may be moved outward from the angled port so that the shock wave generating regions 1511, 1513 are further away from the central axis 1520 of the catheter 1500. For example, a first shock wave generating emitter may be configured to be located along and extend along a first emitter axis through a first emitter port, and a second shock wave generating emitter may be configured to be located along and extend along a second emitter axis through a second emitter port. In some embodiments, the first and / or second emitter axes are not parallel to the central longitudinal axis. In the first configuration, the shock wave generation region may be located within the emitter port, and in the second configuration (e.g., an extended configuration), the shock wave generation region may be located at least 0.5 millimeters (0.5 mm) outside the emitter port. The angled ports 1531 and 1533 induce outward movement of the shock wave generation region along the emitter axis which is non-parallel to the central longitudinal axis. This outward movement of the shock wave generation region may be approximately equal to the port angle 1561, which may be 10 degrees or more. In one or more embodiments, the port angle 1561 is about 15 degrees to about 85 degrees. In one or more embodiments, the port angle 1561 is about 45 degrees to about 60 degrees. In one or more embodiments, at least one of the shock wave emission regions is located about 3 millimeters (3 mm) to about 6 millimeters (6 mm) from the central longitudinal axis in the extended configuration. In one or more embodiments, at least one of the shock wave emission regions is closer to the wall of the encapsulation body than to the central longitudinal axis in the extended configuration. In one embodiment, at least one shock wave generation region is at least 1 millimeter (1 mm) away from the wall of the encapsulation body in the extended configuration.

[0286] In some embodiments, the shock wave catheter includes at least one shock wave generating emitter movably connected to the extension tube. In some embodiments, the at least one shock wave generating emitter is movably connected to the extension tube such that, in a first configuration, at least one emitter is in a first position, and in a second configuration, at least one emitter is in a second position further from the central longitudinal axis than in the first position. In some embodiments, the at least one emitter in the second position is at least 3 millimeters (3 mm) further from the central longitudinal axis than in the first position. In other embodiments, the at least one emitter in the second position is at least 6 millimeters (6 mm) further from the central longitudinal axis in the second position, or at least 10 millimeters (10 mm) further from the central longitudinal axis in the second position.

[0287] Figure 16 illustrates an exemplary method of using a shock wave catheter having outwardly movable shock wave generating regions to treat an occlusion, such as catheters 200B and 300A-C shown in separate Figures 3A-3B and 6A-6C. In step 1601, the catheter is advanced within a body lumen. The catheter includes multiple shock wave generating regions (e.g., emitters) located along an adjustable support structure and surrounded by an inclusion body at its distal end. In step 1602, the catheter is positioned such that a first emitter is located distal to the occlusion (i.e., between the occlusion and the distal end of the catheter) and a second emitter is located proximal to the occlusion (i.e., between the occlusion and the proximal end of the catheter). In step 1603, the inclusion body is filled and pressurized (e.g., to a pressure of approximately 2 to 6 atm or up to approximately 4 atm). In step 1604, the support structure is expanded so that the first and second emitters of the plurality of emitters are positioned laterally away from the catheter extension tube and closer to the occlusion. In some embodiments, the step of expanding the support structure also moves the first and second emitters closer longitudinally to (and relative to) the occlusion. In step 1605, power is supplied to the plurality of emitters so that the first and second emitters emit shock waves and treat the occlusion from both the distal and proximal sides. In some embodiments, the first and second shock wave generating emitters are supplied with power so that shock waves are generated substantially simultaneously from the first and second emitters. In some embodiments, the first and second shock wave generating emitters each include a pair of electrodes, and the step of supplying power to the emitters includes the step of applying a voltage across each pair of electrodes. Method 1600 may be particularly useful for treating eccentric lesions. Method 1600 may be implemented by embodiments shown, for example, in Figures 3A and 3B and Figures 6A, 6B, and 6C, as described above.

[0288] Figure 17 illustrates another exemplary method of using a shock wave catheter having outwardly movable shock wave generating regions to treat an occlusion, such as catheters 200B and 300A-C shown in separate Figures 3A-3B and 6A-6C. In step 1701, a catheter having multiple shock wave generating regions, with first, second, third, and fourth shock wave generating regions at its distal end, is advanced within a body lumen. The catheter may be advanced such that the first emitter is located distal to the lesion and the second emitter is located proximal to the lesion. The shock wave generating regions are located on an adjustable support structure and may be surrounded by an inclusion body (e.g., an angioplasty balloon). The support structure may expand laterally with respect to the central longitudinal axis of the extension tube, and may be configured to move the first, second, third, and fourth emitters further away from the central longitudinal axis. The first and second shock wave generating regions are aligned circumferentially and spaced apart axially. The first and third shock wave generating regions are aligned axially. The third emitter is offset circumferentially from the second emitter. The third and fourth shock wave generating regions are aligned circumferentially. The fourth shock wave emitter is aligned axially with the second emitter. In step 1702, the inclusion is filled with a fluid (for example, to a pressure of about 2 atm to 6 atm or about 4 atm). In some embodiments, the inclusion is expanded with a fluid such as a conductive fluid. In step 1703, the support structure is expanded so that the shock wave generating regions are moved laterally away from the central longitudinal axis of the catheter. In some embodiments, the step of moving the first and second emitters laterally away from the extension tube moves the first and second emitters closer to each other (for example, to promote constructive interference between shock waves generated at the emitters in order to increase the shock wave energy delivered to the lesion). In step 1704, power is supplied to a plurality of shock wave generating regions. When power is supplied, the shock wave generating regions are configured to either (a) generate shock waves from one of a pair of circumferentially aligned shock wave generating regions or (b) generate shock waves from one of a pair of axially aligned shock wave generating regions.To treat eccentric lesions (i.e., from the distal and proximal sides of the lesion), it may be advantageous to synchronize the pulsing of circumferentially aligned shock wave generating regions. To treat relatively large vessels (e.g., carotid arteries), it may be advantageous to synchronize the pulsing of axially aligned shock wave generating regions. In some embodiments, the step of supplying power to the emitter assembly includes supplying power to first and second emitters and generating shock waves substantially simultaneously in the first and second emitters.

[0289] Figures 18A and 18B illustrate an exemplary catheter 1800 having a laterally movable shock wave emitter configured to allow the user to vary the distance between the shock wave emitter and the lesion. The catheter 1800 is further configured to allow a fluid (e.g., blood) to flow around the catheter 1800 during shock wave therapy. The catheter 1800 includes a catheter body 1801 and a laterally (e.g., radially) expandable structure 1820 located in the distal emitter region 1805 of the catheter 1800. Figure 18A illustrates the expandable structure 1820 in an expanded configuration, and Figure 18B illustrates the expandable structure 1820 in a collapsed position. During therapy, the catheter 1800 may be advanced through a body lumen to a lesion within the body lumen. The expandable structure 1820 may be expanded into an expanded configuration such that multiple shock wave emitter assemblies 1824a-1824c, positioned on multiple expandable emitter supports 1822a-1822c, are positioned closer to the lesion than when the expandable structure 1820 is in a collapsed configuration. Gaps (e.g., channels) may be maintained between each of the individual expandable emitter supports 1822a-1822c in the expanded configuration so that fluid can flow around the catheter 1800 beyond the emitter supports 1822a-1822c. Figures 18A and 18B depict an embodiment of the expandable structure 1820 having three emitter supports 1822a-1822c, but it should be understood that the expandable structure 1820 may contain any number of emitter supports 1822a-1822c.

[0290] The expandable structure 1820 may be movable between the expansion configuration shown in Figure 18A and the compression configuration shown in Figure 18B, using a movable shaft 1810 connected to the expandable structure 1820. In some embodiments, moving the movable shaft 1810 proximal to the expandable structure 1820, toward the proximal portion of the catheter, can expand the expandable structure 1820 laterally, and moving the movable shaft 1810 distal to the expandable structure 1820, toward the distal portion of the catheter, can compress the expandable structure 1820 laterally, as shown in Figure 18B. Thus, in the lateral compression configuration of the expandable structure 1820, the movable shaft 1810 can be in a proximal position. In the lateral expansion configuration of the expandable structure, the movable shaft can be in a distal position. It should be understood that other structures for enabling lateral expansion or compression of the expandable structure 1820 are also possible. For example, the flexible region of the expandable structure may be formed from a shape-memory material such as nitinol and configured to flex when exposed to external stimuli such as temperature changes or pH changes within a body lumen. In addition, although the emitter supports 1822a-1822c are shown in Figures 18A and 18B as extending into separate lumens 1812a-1812c, in some embodiments the expandable emitter supports 1822a-1822c may extend together through a single lumen of the catheter body 1801.

[0291] In some embodiments, the catheter body 1801 may have a central lumen 1818 extending along the catheter body 1801. The movable shaft 1810 may extend proximal through the catheter body 1801 from a distal end member 1803 positioned distal to the distal emitter region 1805 via the central lumen 1801 to the proximal portion of the catheter 1800. The movable shaft 1810 may define a central longitudinal axis in the distal emitter region, and the distance of the emitter supports 1822a-1822c from the central axis may be adjustable to move the shock wave emitter assembly 1824a-1824c closer to the site of the lesion. For example, the movable shaft 1810 may be movable (e.g., longitudinally slidable distally and proximal) relative to the expandable emitter supports 1822a-1822c within the central lumen 1818. The movable shaft 1810 may be connected to the distal end member 1803 such that proximal or distal movement of the movable shaft 1810 results in corresponding proximal or distal movement of the distal end member 1803. The expandable emitter support 1822a-1822c may extend from the distal emitter region 1805 distal to the distal end member 1803 and proximal through the catheter body 1801 to the proximal portion of the catheter (e.g., to the hub or handle) via a plurality of lumens 1812a-1812c. The expandable emitter support 1822a-1822c may be fixedly connected to both the distal end member 1803 and the plurality of lumens 1812a-1812c of the catheter body 1801. Applying an axial force to the movable shaft 1810 can cause the expandable structure 1820 to be crushed and expanded as the movable shaft 1810 and distal end member 1803 move, for the connection between the expandable emitter support 1822a-1822c and the distal end member 1803 and the multiple lumens 1812a-1812c of the catheter body 1801.

[0292] In some embodiments, the expandable emitter supports 1822a-1822c may each include an outer extension member 1852a-1852c and an inner extension member 1804a-1804c. The outer extension members 1852a-1852c may be encapsulants that enclose one or more shock wave emitter assemblies 1824a-1824c positioned on the expandable emitter supports 1822a-1822c. In some embodiments, the outer extension members 1852a-1852c may be flexible (but not inflatable) tubes configured to bend when the expansion structure 1820 is positioned in the expansion configuration. In some embodiments, the outer extension members 1852a-1852c may be inflatable balloons. The expandable structure 1820 and emitter supports 1822a-1822c may be configured to expand so that the outer extension members 1852a-1852c come into contact with the inner wall of the body lumen and / or a lesion within the lumen.

[0293] In some embodiments, when in the expanded configuration, portions of the emitter supports 1822a-1822c are positioned such that a gap is formed between each of the outer extension members 1852a-1852c, allowing blood to flow through the expandable structure 1820 and enabling longer treatment procedures than would be possible with conventional angioplasty balloons that completely occlude the vessel being treated. In some embodiments, the expandable structure 1820 may be biased toward the collapsed position shown in Figure 18B. The catheter 1800 may advance within the body lumen while the expandable structure 1820 is in the collapsed state. Once the catheter is positioned so that the shock wave emitter assembly 1824a-1824c is in the desired location (e.g., adjacent to the lesion), the expandable support structure 1820 may be expanded to move the shock wave emitter assembly 1824a-1824c relatively closer to the lesion.

[0294] One or more shock wave emitter assemblies 1824a-1824c may be positioned on each of the inner extension members 1804a-1804c. The inner extension members may be extension shafts (e.g., tubes). In some embodiments, each of the inner extension members 1804a-1804c may include a lumen extending along the length of the individual inner extension member 1804a-1804c. In some embodiments, individual core extension members 1842a-1842c may be positioned within the lumen of each of the inner extension members 1804a-1804c. The core extension members 1842a-1842c may consist of a shape memory material (e.g., nitinol) and may extend from the distal end member 1803 to the catheter body 1801.

[0295] In some embodiments, the outer extension members 1852a-1852c may contain thermoplastic polyurethane having a Shore A hardness of 80-100. The inner extension members 1804a-1804c may contain high-density polyethylene having a density greater than 0.9 g / cc. The core extension members 1842a-1842c may contain thermoplastic elastomer and / or polyether block amide.

[0296] In some embodiments, the expandable emitter supports 1822a-1822c each include a proximal region 1868 that extends distally from the catheter body 1801 to a first transition region 1866. The transition region 1866 may extend distally from the proximal region 1868 to a central region 1864, which may extend distally to a second transition region 1862. The second transition region 1862 may extend distally from the central region 1864 to a distal region 1860, which extends from the transition region 1862 to a distal end member 1803. The central region 1864 may be configured to remain parallel to the central longitudinal axis defined by the movable shaft 1810 in both the collapsed configuration (shown in Figure 18B) and the expanded configuration (shown in Figure 18A).

[0297] In some embodiments, the first and second transition regions 1866 and 1862 include bending or hinge operating regions that allow the expandable emitter supports 1822a-1822c to expand outward away from the central longitudinal axis. The bending or hinge operating regions may be configured to bend in response to the movable shaft 1810 being pushed proximal or distally. In some embodiments, the bending or hinge operating regions include a plurality of hinges (e.g., living hinges). In some embodiments, the transition region 1866 includes a first bending region at the proximal end portion of the transition region 1866 and a second bending region at the distal end portion of the transition region 1866. In some embodiments, the transition region 1862 includes a first bending region at the proximal end portion of the transition region 1862 and a second bending region at the distal end portion of the transition region 1862. In the expanded configuration, the first and second bending regions (both the first transition region 1866 and the second transition region 1862) may form an arc shape, oriented in opposing directions and connected by the central portions of the individual transition regions. Thus, in some embodiments, the transition regions 1866 and 1862 may form an "S" or "zigzag" shape in the expanded configuration. In some embodiments, the outer extension members 1852a-1852c may be relatively thinner in the individual bending regions compared to the central region. The relatively thinner portions of the outer extension members 1852a-1852c in the bending regions may allow the expandable support structure to transition more easily between a compressed configuration and an expanded configuration with respect to a structure having a constant thickness. The bending regions may contain a superelastic material such as nickel-titanium (nitinol). The bending regions may be treated (e.g., by heat treatment) to conform to a bending configuration in response to the application of a longitudinal force and return to a substantially linear configuration when the longitudinal force is removed. In some embodiments, one or more of the expandable emitter supports 1822a-1822c may instead form a continuous arc shape when in the expanded configuration. In such embodiments, one or more expandable emitter supports 1822a-1822c may not include discrete bending or hinge operating regions.

[0298] The outer extension members 1852a-1852c may each be configured to be fluidically connected to a fluid source and filled with a conductive fluid. When filled with a conductive fluid, the outer extension members 1852a-1852c may be configured not to expand, or to expand only minimally, and therefore the size of the gap between each of the outer extension members 1852a-1852c may remain relatively constant in the expanded configuration, regardless of whether the outer extension members 1852a-1852c are filled or not. In some embodiments, when filled with a conductive fluid, the outer diameter of the outer extension members 1852a-1852c may expand by up to 1 mm when filled and pressurized to a maximum working pressure of 4 atm.

[0299] In some embodiments, the outer diameter of the outer extension members 1852a-1852c is constant along the entire length of the outer extension members 1852a-1852c. In some embodiments, the outer diameter of the outer extension members 1852a-1852c is constant along the length of the outer extension members 1852a-1852c within the distal emitter region 1805. In some embodiments, each emitter support 1822a-1822c may have an outer diameter of 0.03 inches to 0.06 inches (e.g., 0.048 inches) in the distal emitter region 1805. In some embodiments, each outer extension member may have a wall thickness of 0.001 inches to 0.005 inches (e.g., 0.002 inches). As shown in the collapse configuration depicted in Figure 18B, the catheter body may have a proximal outer diameter 1802 that is equal to or greater than the maximum width of the expandable structure 1820 when the expandable structure 1820 is in the collapse configuration. The distal end member 1803 may include a distal outer diameter 1807. The expandable structure 1820 may have a maximum width less than or equal to the proximal outer diameter 1807 in the collapse configuration. However, when in the expanded configuration, the expandable structure 1820 may have a maximum width exceeding both the proximal diameter 1802 and the distal diameter 1803. In the distal emitter region 1805, the catheter 1800 may have a maximum expanded diameter in the lateral expanded configuration and a collapsed diameter in the lateral collapse configuration. The maximum expanded diameter may exceed the collapsed diameter by 0.2 inches to 1.0 inch (e.g., 0.7 inches).

[0300] Figure 19 shows a cross-sectional front view of the distal emitter region 1805 of catheter 1800 as depicted in Figures 18A and 18B in the expanded configuration. In the expanded configuration depicted in Figure 19, catheter 1800 has an expanded maximum width w, labeled 1830. In the expanded configuration, catheter 1800 is given by the following equation, i.e., FP = π(w / 2) 2 It has an expanded area occupancy FP, labeled as 1820, which can be determined according to [the relevant standard]. The proximal diameter 1802 of the catheter 1800 described above may have a cross-sectional area equal to less than 50% of the expanded area occupancy FP. In some embodiments, the expanded configuration is sized to treat iliac artery disease and / or structural heart disease.

[0301] Looking again at Figures 18A and 18B, the shock wave emitter assemblies 1824a-1824c may include at least one shock wave emitter, each including at least one electrode pair. The shock wave emitter assemblies 1824a-1824c include a shock wave emitter including the distal end of an optical fiber. In the case of electrohydraulically generated shock waves, each emitter includes an electrode pair having a first electrode and a second electrode separated by a spark gap, and each electrode of the electrode pair is electrically connected to a power source (for example, by a wire extending along the length of the catheter body). The electrode pairs along the emitter shaft may be connected in series with each other. With respect to embodiments including multiple emitter supports (e.g., 1822a-1822c), the electrode pairs along each emitter support 1822, 1822b, and 1822c may be connected in series to a single channel of a power generator. In some embodiments, electrode pairs along emitter supports 1822, 1822b, and 1822c may be connected to different channels of a power generator. In other embodiments, electrode pairs of different emitter supports 1822, 1822b, and 1822c may be connected in parallel from one another. In the case of an optical energy generation shock wave, the optical fiber extends from the light source (e.g., a laser) to the distal emitter region 1805, and the optical energy pulse generates a shock wave at the distal end of the optical fiber.

[0302] FIG. 20 illustrates a detailed view of a shock wave emitter assembly 2024 that can be used as any one of the emitter supports 1822a - 1822c of FIGS. 18A and 18B and that is positioned on an emitter support 2022 of a catheter 2000 that can be used as any one of the shock wave emitter assemblies 1824a - 1824c of FIGS. 18A and 18B. As shown, a plurality of shock wave emitter assemblies 2024 may be positioned on emitter support 2022. Each emitter assembly may include an outer electrode 2027 and an inner electrode 2029 separated by a spark gap 2005. The outer electrode 2027 of each emitter assembly 2024 may be a conductive cylinder positioned on an extended inner member 2004 of emitter support 2022. In some embodiments, an insulating layer 2032 may be positioned between an individual outer electrode 2027 and inner extension member 2004. In some embodiments, the inner electrode 2029 of each emitter assembly 2024 may be an exposed conductive portion of an energy guide 2030. In some embodiments, one or more of the energy guides 2030 may be wires that extend along at least a portion of the inner extension member 2004. One or more of the energy guides 2030 may extend from an energy source connected to a proximal portion of the catheter 2000 to the shock wave emitter assembly 2024.

[0303] An outer extension member 2052 may enclose the shock wave emitter assembly 2024. The outer extension member 2052 may be an extended cylindrical tube configured to be filled with a conductive fluid prior to and / or subsequent to shock wave generation. Unlike the balloon enclosure described above, the outer extension member 2052 does not expand to conform to the diameter of the body lumen into which the catheter is inserted. The outer diameter of the outer extension member 2052 remains constant or expands only minimally when filled with a conductive fluid. The shock wave emitter assembly 2024 may be positioned relatively closer to a lesion within a body lumen as compared to conventional shock wave catheter configurations that utilize an inflatable balloon enclosure.

[0304] In some embodiments, the emitter assemblies 2024 are connected in series, and as current flows across each spark gap 2005 between the inner electrode 2029 and outer electrode 2027 of the individual emitter assemblies 2024, the power supplied by the power supply (e.g., a voltage pulse) generates a shock wave in each of the emitter assemblies 2024. In some embodiments, one or more of the emitter assemblies 2024 may be routed on a separate circuit or circuit branch so that the voltage pulse can be selectively applied to only a desired subset of the emitters.

[0305] Various components and layers of the shock wave catheter may include polymer materials. The polymer materials may include one or more of thermoplastic polyurethane (TPU), polyimide (PI), polytetrafluoroethane (PTFE), polyether block amide (PEBA), and polyamide. Components configured to slide longitudinally relative to each other (e.g., movable shafts 1810) may include relatively more lubricating materials such as PTFE or PTFE-containing composite materials (e.g., PI and PTFE composite materials).

[0306] Figure 21 illustrates an exemplary method for treating a lesion in a body lumen. Block 2102 describes the method, which includes advancing an IVL catheter having a laterally expandable structure, including a shock wave emitter assembly, through a body lumen. The laterally expandable structure may be in a laterally collapsed configuration while the catheter is advanced within the body lumen. The catheter may include any of the features described with respect to the exemplary catheter disclosed herein. Block 2104 describes the method, which includes positioning the emitter assembly adjacent to the lesion. The emitter assembly may be advanced within the body lumen until one or more shock wave emitters are positioned in a location within the body lumen that is longitudinally aligned with the lesion.

[0307] In block 2106, the method includes moving the emitter assembly closer to the lesion by laterally expanding a laterally expandable structure. The laterally expandable structure may be expanded according to any of the methods described herein. In some embodiments, laterally expanding the laterally expandable structure includes moving a movable shaft connected to the laterally expandable structure from a distal to a proximal position, or moving the movable shaft from a proximal to a distal position. In some embodiments, moving the emitter assembly closer to the lesion by laterally expanding the laterally expandable structure creates multiple gaps between multiple components of the laterally expandable structure (e.g., emitter supports 1822a-1822c). The multiple gaps allow blood to flow beyond the IVL catheter when the laterally expandable structure is expanded.

[0308] In Block 2108, the method includes introducing a solution into an emitter assembly through a fluid lumen of a laterally expandable structure. In some embodiments, introducing the solution includes drawing a vacuum over the fluid lumen at the proximal end of the fluid lumen, replacing the vacuum with a fluid source, and filling the laterally expandable structure with the solution to expel air from the laterally expandable structure. The solution may be a conductive fluid such as saline or a contrast agent solution. The solution may fill an inclusion of the laterally expandable structure. The inclusion may be pressurized by the solution to a pressure of 5 atm or less. In some embodiments, the pressure of the inclusion may be 1 atm to 4 atm. The inclusion may enclose an emitter assembly positioned on a laterally expandable support structure. The inclusion may have a uniform outer diameter and may be configured not to expand, or to expand only minimally in a uniform manner along the length of the inclusion, when filled with the solution. In some embodiments, introducing a solution through a fluid lumen causes the inclusion to expand by up to 1 millimeter (1 mm) when filled and pressurized to a working pressure of up to 4 atmospheres (4 atm).

[0309] In block 2110, the method includes supplying energy to the emitter assembly from an energy source connected to the emitter assembly by an energy guide, thereby generating one or more shock waves. The energy source may be a voltage generator or a laser. In embodiments where the emitter assembly includes a pair of electrodes, the energy guide may be a wire or other conductive member for transmitting current to the emitter assembly. In embodiments where the emitter assembly includes the end (e.g., distal end) of an optical fiber, the energy guide may be an optical fiber for transmitting laser pulses from a laser to the distal end of the optical fiber. In block 2112, the method may include laterally crushing the expandable structure. The method may also include further advancing the catheter in the lumen, expanding the expandable structure again, and generating one or more additional shock waves.

[0310] Figure 22 illustrates another exemplary method for treating a lesion in a body lumen, in which the expandable structure is expanded so that the outer extension member of the laterally expandable structure contacts the lesion. Block 2202 describes the method, which includes advancing an IVL catheter having a laterally expandable structure, including a shock wave emitter assembly, through a body lumen. The laterally expandable structure may be in a laterally collapsed configuration while the catheter is advanced within the body lumen. The catheter may include any of the features described with respect to the exemplary catheter disclosed herein. Block 2204 describes the method, which includes positioning the emitter assembly adjacent to the lesion. The emitter assembly may be advanced within the body lumen until one or more shock wave emitters are positioned in a location within the body lumen that is longitudinally aligned with the lesion.

[0311] In block 2206, the method includes moving the emitter assembly closer to the lesion by laterally expanding the laterally expandable structure such that the outer extension member of the laterally expandable structure contacts the lesion. The laterally expandable structure may be expanded according to any of the methods described herein. In some embodiments, laterally expanding the expandable structure includes moving a movable shaft connected to the expandable structure from a distal to a proximal position, or moving the movable shaft from a proximal to a distal position. In some embodiments, moving the emitter assembly closer to the lesion by laterally expanding the laterally expandable structure creates multiple gaps between multiple components of the laterally expandable structure (e.g., emitter supports 1822a-1822c). The multiple gaps allow blood to flow beyond the IVL catheter when the laterally expandable structure is expanded.

[0312] In Block 2208, the method involves introducing a solution into an emitter assembly through a fluid lumen of a laterally expandable structure. In some embodiments, introducing the solution involves drawing a vacuum over the fluid lumen at the proximal end of the fluid lumen, replacing the vacuum with a fluid source, and filling the laterally expandable structure with the solution to expel air from the laterally expandable structure. The solution may be a conductive fluid such as saline or a contrast agent solution. The solution may fill an inclusion of the laterally expandable structure. The inclusion may enclose an emitter assembly positioned on the laterally expandable structure. The inclusion may have a uniform outer diameter and may be configured not to expand, or to expand only minimally in a uniform manner along the length of the inclusion, when filled with the solution. In some embodiments, introducing the solution through the fluid lumen expands the inclusion by up to 1 mm when filled and pressurized to a maximum working pressure of 4 atm.

[0313] In block 2210, the method includes supplying energy to the emitter assembly from an energy source connected to the emitter assembly by an energy guide, thereby generating one or more shock waves. The energy source may be a voltage generator or a laser. In embodiments where the emitter assembly includes a pair of electrodes, the energy guide may be a wire or other conductive member for transmitting current to the emitter assembly. In embodiments where the emitter assembly includes the end (e.g., distal end) of an optical fiber, the energy guide may be an optical fiber for transmitting laser pulses from a laser to the distal end of the optical fiber. In block 2212, the method may include laterally crushing the expandable structure. The method may also include further advancing the catheter in the lumen, expanding the expandable structure again, and generating one or more additional shock waves.

[0314] While the catheter devices and methods described herein are primarily discussed in the context of treating coronary artery indications such as intravascular lesions, the catheter devices described herein can be used for a variety of indications. For example, similar designs and methods may be used to treat soft tissues such as cancer and tumors (i.e., non-thermal ablation methods), blood clots, uterine fibroids, cysts, organs, scars and fibrous tissue removal, or other tissue destruction and removal treatments. Catheter devices and methods may be used for nerve stimulation therapy, targeted drug delivery, treatment of tumors in body lumens (e.g., tumors in blood vessels, esophagus, intestines, stomach, or vagina), wound treatment, non-surgical removal, and tissue destruction, or as an alternative to thermal treatment or cauterization for venous insufficiency and tubal ligation (i.e., permanent female contraception). In some embodiments, the catheters disclosed herein may be used to treat sclerotic tissue in the esophagus. The catheters described herein may be used to treat lumens in the ear or nose, such as narrowed areas of lumens in the ear or nose. The catheters disclosed herein can generate shock waves to disrupt bone structures within a stenotic area while minimizing damage to soft tissue, thereby restoring adequate drainage. Furthermore, the catheter devices and methods described herein can also be used for tissue engineering methods, for example, for mechanical tissue decellularization to generate a bioactive scaffold in which new cells (e.g., extrinsic and endogenous cells) can replace old cells, i.e., by introducing porosity to a site, improving cell retention, cell invasion / migration, and the diffusion of nutrients and signaling molecules, thereby promoting angiogenesis, cell proliferation, and tissue regeneration, as well as cell replacement therapy. Such tissue engineering methods may be useful for treating ischemic heart disease, fibrotic liver, fibrotic intestine, and traumatic spinal cord injury (SCI). For example, with respect to the treatment of spinal cord injury, the devices and assemblies described herein can facilitate the removal of scarred spinal cord tissue, acting as a barrier to neuronal reconnection, before the injection of an anti-inflammatory hydrogel loaded with lentiviruses to genetically manipulate and regenerate spinal cord nerve cells.

[0315] It should be noted that the elements and features of the exemplary catheters illustrated throughout this specification and drawings may be rearranged, recombined, and modified without departing from the disclosure. For example, while this specification and drawings describe and illustrate catheters having several exemplary balloon designs, the disclosure is intended to include catheters having a variety of balloon configurations. Without departing from the disclosure, the number, placement, and spacing of electrode pairs in a shock wave emitter may be modified, and the number, placement, and spacing of catheter encapsulants may be modified.

[0316] It should be understood that the foregoing is merely illustrative, and various modifications, alterations, and combinations can be made by those skilled in the art without departing from the scope and spirit of this disclosure. Any of the various catheter modifications disclosed herein may include features described by any other catheter or combination of catheters herein. Furthermore, any of the methods may be used in combination with any of the disclosed catheters. Therefore, the systems, catheters, and methods described herein are not intended to be limited except by the appended claims.

Claims

1. A catheter for treating lesions in the body's tubular lumen, wherein the catheter is Extension tube and A sealing body is sealed at the distal end of the extension tube, An emitter assembly disposed within the aforementioned enclosure, wherein the emitter assembly is At least one emitter is configured to generate a shock wave inside the encapsulation when power is supplied to at least one emitter, A support structure for supporting the at least one emitter, wherein the support structure extends outward with respect to the central longitudinal axis of the extension tube and is configured to move the at least one emitter further away from the central longitudinal axis, and The emitter assembly includes A catheter equipped with [a specific feature / equipment].

2. The catheter according to claim 1, wherein the support structure comprises a plurality of compartments connected by individual joints.

3. The catheter according to claim 2, wherein the at least one emitter is mounted on the support structure in proximity to one or more of the joints.

4. The catheter according to claim 3, wherein the at least one emitter comprises a first emitter mounted in proximity to a first joint of the support structure and a second emitter mounted in proximity to a second joint of the support structure.

5. The catheter according to claim 2, wherein the joint of the support structure is configured to hinge in alternating directions such that the first emitter moves outward from the longitudinal axis in a first direction and the second emitter moves outward from the longitudinal axis in a second direction opposite to the first direction.

6. The catheter according to claim 2, wherein the at least one emitter comprises a first electrode mounted on a first compartment and a second electrode mounted on a second compartment, so that the spark gap between the electrodes is between the first compartment and the second compartment.

7. The catheter according to claim 2, wherein one or more of the joints are living hinges.

8. The catheter according to claim 1, wherein the at least one emitter comprises a first emitter and a second emitter, and the expansion of the support structure moves the first emitter outward from the longitudinal axis in a first direction and the second emitter outward from the longitudinal axis in a second direction lateral to the first direction.

9. The catheter according to claim 8, wherein the at least one emitter further comprises a third emitter, and the extension of the support structure moves the third emitter outward from the longitudinal axis in a third direction lateral to the first and second directions.

10. The catheter according to claim 1, wherein the at least one emitter comprises a first emitter and a second emitter, and the lateral expansion of the support structure moves the first emitter and the second emitter along a first plane intersecting the longitudinal axis, so as to move laterally away from the longitudinal axis in opposing directions.

11. The catheter according to claim 1, wherein the at least one emitter comprises a first emitter and a second emitter, and the lateral expansion of the support structure moves the first emitter laterally away from the longitudinal axis along a first plane that is coplanar with the longitudinal axis, and moves the second emitter outward from the longitudinal axis along a second plane that is coplanar with the longitudinal axis and transverse to the first plane.

12. The catheter according to claim 11, wherein the first and second planes are perpendicular to each other.

13. The catheter according to claim 11, wherein the at least one emitter further comprises a third emitter, and the extension of the support structure moves the third emitter outward from the longitudinal axis along a third plane that is coplanar with the longitudinal axis and transverse to the first and second planes.

14. The catheter according to claim 12, wherein the at least one emitter further comprises a third emitter and a fourth emitter, and the expansion of the support structure moves the first emitter and the third emitter outward from the longitudinal axis in opposing directions along the first plane, and the expansion of the support structure moves the second emitter and the fourth emitter outward from the longitudinal axis in opposing directions along the second plane.

15. The catheter according to claim 1, wherein the emitter assembly further comprises an extension member extending along the longitudinal axis through at least a portion of the expandable support structure.

16. The catheter according to claim 15, wherein the support structure comprises one or more openings, and the extension member extends through one or more of the openings.

17. The catheter according to claim 15, wherein movement of the extension member in the proximal or distal direction causes expansion of the support structure.

18. The catheter according to claim 17, wherein the expanded diameter of the support structure can be controlled by moving the extension member in the proximal or distal direction.

19. The catheter according to claim 18, wherein the extension member includes one or more markings that indicate to the user the amount of movement of the extension member associated with one or more expanded diameters of the support structure.

20. The catheter according to claim 17, wherein the support structure comprises a first stop portion and a second stop portion, which are separated when the support structure is in a compressed state and come into contact when the support structure is in an expanded state.

21. The catheter according to claim 20, wherein the extension member is operably coupled to at least one of the first stop portion and the second stop portion such that the movement of the extension member causes the first stop portion to move relative to the second stop portion.

22. The catheter according to claim 17, wherein the extension member comprises a wire, and the movement of the wire in the proximal direction causes expansion of the support structure.

23. The catheter according to claim 17, wherein the extension member comprises a first tube and a second tube surrounding at least a portion of the first tube, and movement of the first tube relative to the second tube causes expansion of the support structure.

24. The catheter according to claim 17, wherein moving the extension member by a predetermined distance causes the support structure to be reversibly locked in the extended state.

25. The catheter according to claim 1, wherein in a collapsed state, the support structure has a diameter of less than 1 mm.

26. The catheter according to claim 1, wherein the support structure is expandable to a diameter of at least 5 mm.

27. The catheter according to claim 1, wherein the support structure is expandable to a diameter of at least 1 cm.

28. The catheter according to claim 1, wherein the inclusion body is an angioplasty balloon.

29. The catheter according to claim 1, wherein the encapsulant has an expansion diameter of 8 mm to 12 mm.

30. The catheter according to claim 1, wherein the encapsulating body has an expansion diameter greater than 20 mm.

31. The catheter according to claim 1, wherein the body lumen is a blood vessel or a valve.

32. The catheter according to claim 1, wherein the support structure is formed from an elastic material selected from the group consisting of metals or polymer materials.

33. The catheter according to claim 1, wherein, after expansion of the support structure, the structure can return to substantially the same configuration as in the collapsed state.

34. The catheter according to claim 1, wherein the material properties of the support structure bias the support structure into a compressed state.

35. The catheter according to claim 1, wherein the material properties of the support structure bias the support structure into an expanded state.

36. The catheter according to claim 1, further comprising one or more springs connected to the proximal or distal end of the support structure.

37. The catheter according to claim 36, wherein the one or more springs are configured to bias the support structure into a compressed state.

38. The catheter according to claim 36, wherein the one or more springs are configured to bias the support structure into an expanded state.

39. The catheter according to claim 1, wherein the emitter assembly further comprises a first wire and a second wire, the first and second wires extending along at least a portion of the extension tube and configured to apply a voltage to one or more of the at least one emitter, thereby transmitting a current across at least one electrode pair of the at least one emitter.

40. The catheter according to claim 1, wherein at least a portion of the support structure is conductive and configured to provide a voltage to the at least one emitter.

41. The catheter according to claim 1, wherein the at least one emitter is oriented to generate shock waves outward from the longitudinal axis.

42. The support structure comprises a flexible ribbon, In the first configuration, the ribbon is substantially unwound, In the second configuration, the ribbon is wound in a spiral shape, and the at least one emitter is located at least 1 mm away from the central longitudinal axis of the encapsulation body. The catheter according to claim 1.

43. The shock wave catheter according to claim 42, wherein in the second configuration, the at least one emitter is located about 3 mm to 6 mm away from the central longitudinal axis of the encapsulation body.

44. The shock wave catheter according to claim 42, wherein the second configuration is such that the at least one emitter is less than 1 mm away from the wall of the encapsulation body.

45. The shock wave catheter according to claim 42, wherein the encapsulant is an angioplasty balloon, and in the second configuration, the balloon is filled to a pressure of about 1 atm to about 6 atm.

46. The shock wave catheter according to claim 42, wherein the ribbon is configured to be in the first configuration when the encapsulating body is not expanded, and to automatically change to the second configuration when the encapsulating body is expanded.

47. The shock wave catheter according to claim 42, wherein the support structure is connected to a rotatable proximal handle, and the rotation of the proximal handle changes the ribbon from the first configuration to the second configuration.

48. A catheter for treating lesions in the body's tubular lumen, wherein the catheter is Extension tube and At least one emitter configured to generate a shock wave when power is supplied to at least one emitter, A first encapsulation body surrounding the first emitter of at least one emitter, wherein the first encapsulation body is fillable with a fluid, A second inclusion body, wherein the second inclusion body is fillable with the fluid to expand the second inclusion body, and the expansion of the second inclusion body while the catheter is positioned in a body lumen moves the at least one emitter closer to the lesion in the body lumen, and A catheter equipped with [a specific feature / equipment].

49. The catheter according to claim 48, wherein the first and second encapsulants can be independently filled using the fluid.

50. The catheter according to claim 48, wherein the extension tube comprises a first channel for introducing the fluid into the first sealing body and a second channel for introducing the fluid into the second sealing body.

51. The catheter according to claim 48, wherein the first encapsulant is sealed to the extension tube at one end.

52. The catheter according to claim 48, wherein the first emitter is mounted on the extension tube inside the first encapsulation body.

53. The catheter according to claim 48, wherein the first emitter is positioned on the inner surface of the first encapsulation body.

54. The catheter according to claim 48, wherein the second encapsulant surrounds the second emitter of at least one emitter.

55. The catheter according to claim 54, further comprising a second extension tube, wherein the second encapsulant is sealed in a region of the second extension tube.

56. The catheter according to claim 55, wherein the second extension tube comprises a fluid lumen for introducing fluid into the second sealing body.

57. The catheter according to claim 55, wherein the second emitter is mounted on the second extension tube.

58. The catheter according to claim 54, further comprising a third encapsulation body, the third encapsulation body surrounding the third emitter of at least one emitter.

59. The catheter according to claim 58, wherein the second inclusion is a central inclusion, and the first and third inclusions are positioned adjacent to and around the central inclusion when the catheter is placed in a body lumen.

60. The catheter according to claim 58, wherein the emitter of the first encapsulation body and the emitter of the third encapsulation body are configured to selectively generate shock waves.

61. The catheter according to claim 59, wherein the central encapsulant does not surround the emitter.

62. The catheter according to claim 48, wherein the fluid is a conductive fluid.

63. A catheter for treating lesions in the body's tubular lumen, wherein the catheter is Extension tube and A sealing body that is sealed in the extension tube, wherein the sealing body is fillable with a fluid, At least one emitter is positioned on the inner surface of the encapsulation body and configured to generate a shock wave inside the encapsulation body when power is supplied to at least one emitter, wherein the expansion of the encapsulation body while the catheter is positioned in the body lumen causes the at least one emitter to move closer to the wall of the body lumen, and A catheter equipped with [a specific feature / equipment].

64. The catheter according to claim 63, wherein the at least one emitter is attached to the inner surface of the balloon by adhesion.

65. The catheter according to claim 63, wherein the at least one emitter comprises a plurality of emitters.

66. The catheter according to claim 65, wherein the plurality of emitters are arranged on the inner surface of the balloon in a spiral pattern or grid pattern.

67. The catheter according to claim 63, wherein the at least one emitter is oriented to generate a shock wave outward from the longitudinal axis of the catheter.

68. The catheter according to claim 63, wherein each of the at least one emitters comprises a pair of electrodes forming a spark gap between the electrodes, the spark gap being at least 0.1 mm away from the inner surface of the encapsulation body.

69. The catheter according to claim 68, wherein each of the at least one emitters is configured to maintain the spark gap at least 0.1 mm away from the inner surface of the encapsulation body, and includes a spacer.

70. The catheter according to claim 63, further comprising a first wire and a second wire, wherein the first and second wires extend along at least a portion of the extension tube and are configured to supply power to one or more of the at least one emitters.

71. The catheter according to claim 63, wherein the fluid is a conductive fluid.

72. A system for treating lesions within the body's tubular lumen, wherein the system is The catheter according to claim 1, A power supply configured to supply power to at least one emitter and generate shock waves for treating the lesion, A system that includes these features.

73. A method for treating lesions within the body's tubular lumen, wherein the method is The catheter is advanced within the body lumen to a position close to the lesion. The outer surface of the encapsulation body is inflated so that it contacts the body lumen, Expanding the support structure inside the inclusion body, and positioning at least one emitter placed on the support structure closer to the lesion in the body lumen, To supply power to at least one emitter, generate one or more shock waves inside the inclusion, and treat the lesion. Methods that include...

74. The method according to claim 73, wherein the support structure is extended to move the first emitter outward from the longitudinal axis of the catheter in a first direction, and the second emitter outward from the longitudinal axis in a second direction different from the first direction.

75. The method according to claim 73, wherein the first direction is opposite to the second direction.

76. The method according to claim 73, wherein the support structure comprises a first stop portion and a second stop portion, which are separated when the support structure is in a compressed state and come into contact when the support structure is in an expanded state, and expanding the support structure includes moving the second stop portion toward the first stop portion.

77. The method according to claim 76, wherein extending the support structure includes moving an extension member in a proximal or distal direction, the extension member extending between a first stop and a second stop and being operably coupled to at least one of them.

78. The method according to claim 77, wherein the extension member comprises a first pipe and a second pipe surrounding at least a portion of the first pipe, and the movement of the second pipe relative to the first pipe causes expansion of the support structure.

79. The method according to claim 76, wherein extending the support structure includes pulling a wire operably coupled to at least one of the first stop and the second stop.

80. The method according to claim 73, further comprising rotating the support structure to position the at least one emitter closer to the lesion in the body lumen.

81. The method according to claim 73, wherein the encapsulating body is in a folded state when the catheter is advanced through the body lumen.

82. The method according to claim 73, wherein the diameter of the support structure is less than 1 mm when the catheter is advanced through the body lumen.

83. The method according to claim 73, wherein expanding the support structure includes expanding the support structure to a diameter of 8 mm to 12 mm.

84. The method according to claim 73, wherein expanding the support structure includes expanding the support structure to a diameter greater than 1 cm.

85. The method according to claim 73, further comprising supplying power to one or more emitters, generating one or more shock waves, and then further expanding the support structure.

86. A method for treating lesions within the body's tubular lumen, wherein the method is The catheter is advanced within the body lumen to a position close to the lesion. The first encapsulation body of the catheter is inflated, wherein the first encapsulation body surrounds the first emitter. Inflating the second inclusion of the catheter, while the catheter is positioned within the body lumen, moves the first emitter closer to the lesion within the body lumen. The method involves supplying power to the first emitter, generating one or more shock waves inside the first inclusion, and treating the lesion. Methods that include...

87. The second encapsulation surrounds the second emitter, and the method further, The method according to claim 86, comprising supplying power to the second emitter and generating one or more shock waves inside the second encapsulation.

88. The method according to claim 86, wherein expanding the first and second encapsulants comprises filling the encapsulants with a conductive fluid.

89. The method according to claim 86, wherein expanding the first insulator comprises filling the first insulator with a conductive fluid through a first fluid lumen, and expanding the second insulator comprises filling the second insulator with a conductive fluid through a second fluid lumen.

90. The method according to claim 86, wherein the first and second encapsulants are in a folded state when the catheter is advanced through the body lumen.

91. The method according to claim 86, further comprising rotating the first and second encapsulants around the longitudinal axis of the catheter to move the first emitter closer to the occlusion within the body lumen.

92. The method according to claim 86, further comprising inflating a third inclusion of the catheter, wherein inflating the third inclusion while the catheter is positioned in the body lumen moves the first emitter closer to the lesion in the body lumen.

93. The third encapsulation surrounds the third emitter, and the method further, The method according to claim 92, comprising supplying power to the third emitter and generating one or more shock waves inside the third encapsulation.

94. A method for treating lesions within the body's tubular lumen, The catheter is advanced within the body lumen to a position close to the lesion. The catheter's encapsulation is inflated so that multiple emitters positioned on the inner surface of the encapsulation move closer to the lesion within the body lumen. The process involves supplying power to the plurality of emitters, generating one or more shock waves, and treating the lesion. Methods that include...

95. It is a shock wave catheter, An extension tube having a central longitudinal axis, A sealing body is sealed at the distal end of the extension tube, An adjustable emitter assembly disposed within the aforementioned enclosure, wherein the emitter assembly is An emitter assembly comprising at least one shock wave generating emitter, wherein in a first configuration, at least one emitter is located in a first position, and in a second configuration, the at least one emitter is movably connected to the extension tube such that it is located in a second position which is more than 3 mm further from the central longitudinal axis than the first position, and A shock wave catheter equipped with [a specific feature].

96. It is a shock wave catheter, An extension tube having an emitter port and defining a central longitudinal axis, A sealing body is sealed at the distal end of the extension tube, A shock wave generating emitter located along an emitter axis not parallel to the central longitudinal axis, wherein the emitter axis extends from the central longitudinal axis through the emitter port and A shock wave catheter equipped with [a specific feature].

97. The shock wave catheter according to claim 96, wherein in the first configuration, the shock wave generating emitter is located within the emitter port, and in the second configuration, the shock wave generating emitter is located at least 0.5 mm outside the emitter port.

98. The shock wave catheter according to claim 96, further comprising a second shock wave generating emitter positioned along a second emitter axis not parallel to the central longitudinal axis, wherein the extension tube has a second emitter port, and the second emitter axis extends through the second emitter port.

99. A method for treating lesions within the body's tubular lumen, wherein the method is The catheter, having both a distal and a proximal end, is advanced within the body lumen to a position close to the lesion such that the first shock wave emitter of the catheter is located distal to the lesion and the second shock wave emitter of the catheter is located proximal to the lesion. The method involves using a fluid to inflate the catheter's containment, wherein the containment surrounds the first and second shock wave generating emitters. Moving the first and second shock wave emitters so as to move laterally away from the extension tube of the catheter, Power is supplied to the first and second shock wave emitters, and at least one shock wave is generated from each of the first and second shock wave emitters to treat the lesion. Methods that include...

100. The method according to claim 99, wherein the first and second shock wave generating emitters are powered such that shock waves are generated substantially simultaneously from the first and second emitters.

101. The method according to claim 99, wherein the first and second shock wave generating emitters each comprise a pair of electrodes, and supplying power to the emitters includes applying a voltage across each pair of electrodes.

102. A method for treating lesions within the body's tubular lumen, wherein the method is The procedure involves advancing the catheter within the body lumen to a position close to the lesion, wherein the catheter is Extension tube and A sealing body is sealed at the distal end of the extension tube, A shock wave generating emitter assembly disposed within the aforementioned enclosure, wherein the emitter assembly comprises: The first emitter and The first emitter and the second emitter which are aligned in the circumferential direction, A third emitter is axially aligned with the first emitter and circumferentially offset from the second emitter, A fourth emitter is aligned circumferentially with the third emitter and axially with the second emitter, A support structure for supporting the first, second, third, and fourth emitters, wherein the support structure extends laterally with respect to the central longitudinal axis of the extension tube, and is configured to move the first, second, third, and fourth emitters further away from the central longitudinal axis. The emitter assembly includes To be equipped with, The method involves inflating the catheter's containment using a fluid, wherein the containment surrounds the first, second, third, and fourth shock wave generating emitters. Moving the first, second, third, and fourth emitters so as to move laterally away from the extension tube, To supply power to the emitter assembly and generate one or more shock waves from at least one of the first, second, third, and fourth shock wave generating emitters. Methods that include...

103. The method according to claim 95, further comprising positioning the catheter such that the first emitter is located distal to the lesion and the second emitter is located proximal to the lesion, and powering the emitter assembly includes powering the first and second emitters.

104. The method according to claim 95, wherein moving the first and second emitters toward a lateral distance from the extension tube moves the first and second emitters toward a closer proximity to each other.

105. It is a shock wave catheter, Extension tube and A sealing body that is sealed in the extension tube, wherein the sealing body can be filled with a fluid through the lumen of the extension tube, A flexible ribbon having at least one emitter configured to generate a shock wave when powered, Equipped with, In the first configuration, the ribbon is substantially unwound, In the second configuration, the ribbon is wound in a spiral shape, and the at least one emitter is located at least 1 mm away from the central longitudinal axis of the balloon. Shock wave catheter.

106. The shock wave catheter according to claim 98, wherein in the second configuration, the at least one emitter is located about 3 mm to 6 mm away from the central longitudinal axis of the balloon.

107. The shock wave catheter according to claim 98, wherein the second configuration is such that the at least one emitter is located less than 1 mm away from the wall of the encapsulation body.

108. The shock wave catheter according to claim 98, wherein the encapsulant is an angioplasty balloon, and in the second configuration, the balloon is filled to a pressure of about 2 atm to about 6 atm.

109. A catheter for treating lesions in the body's tubular lumen, wherein the catheter is A catheter body having multiple lumens, The distal tip and A movable shaft extending from the proximal portion of the catheter to the distal tip and movable longitudinally within the first lumen of the multiple lumens of the proximal shaft, A laterally expandable structure comprising at least one emitter support, wherein the at least one emitter support is fixedly positioned within a second lumen of a plurality of lumens of the proximal shaft and extends to the distal end, and the at least one emitter support is Outer extension member and Inner extension member, A shock wave emitter assembly positioned on the inner extension member and A laterally expandable structure is provided. Equipped with, In the lateral compression configuration of the expandable structure, the movable shaft is located in a proximal position. In the lateral expansion configuration of the expandable structure, the movable shaft is located in the distal position. In the lateral expansion configuration, the catheter is configured to allow the passage of fluid around the lateral expansion structure. catheter.

110. In the aforementioned lateral expansion configuration, the catheter has a maximum expansion width w, The catheter has an expanded occupied area FP, FP = π(w / 2) ２ And, The distal end of the catheter body has a cross-sectional area of ​​less than 50% of the FP in the laterally expandable structure. The catheter according to claim 109.

111. The catheter according to claim 109, wherein the laterally expandable structure includes a plurality of emitter supports that are laterally expandable.

112. The catheter according to claim 111, wherein each of the plurality of emitter supports comprises an emitter assembly, and each emitter assembly is separately connected to the energy source.

113. The catheter according to claim 111, wherein each of the plurality of emitter supports is fluidly connected to a fluid source.

114. The catheter according to claim 111, wherein each of the plurality of emitter supports extends proximal through the individual lumens of the plurality of lumens of the proximal shaft.

115. The catheter according to claim 111, wherein the plurality of emitter supports extend proximal together within one lumen of the catheter body.

116. The catheter according to claim 109, wherein the laterally expandable structure includes three emitter supports.

117. The catheter according to claim 109, wherein the emitter support comprises a plurality of hinges.

118. The catheter according to claim 109, wherein the emitter support comprises a shape memory material.

119. The catheter according to claim 109, wherein the emitter support is in contact with the wall of the body lumen in the extended configuration.

120. The catheter according to claim 109, wherein the emitter assembly includes at least one shock wave emitter having at least one electrode pair.

121. The catheter according to claim 109, wherein the catheter body comprises a guidewire lumen.

122. The catheter according to claim 109, wherein the emitter assembly is located further from the central longitudinal axis of the catheter in the lateral expansion configuration than in the lateral collapse configuration.

123. The emitter support is A proximal region extending from the aforementioned proximal shaft, The distal region extends to the distal tip, A central region located between the proximal region and the distal region, The transition region between the central region and the proximal and distal regions. Equipped with, The central region is parallel to the central longitudinal axis of the catheter in both the lateral compression configuration and the lateral expansion configuration. The catheter according to claim 109.

124. The catheter according to claim 123, wherein the emitter support further comprises a bent region at the proximal and distal ends of each transition region.

125. The catheter according to claim 124, wherein the bending region comprises an outer extension member that is thinner than the central region.

126. The catheter according to claim 125, wherein the movable shaft is slidable in the longitudinal direction relative to the emitter support.

127. The catheter according to claim 109, wherein the proximal shaft has a proximal outer diameter, and the expandable structure has a maximum width in the collapse configuration that is less than or equal to the proximal outer diameter.

128. The catheter according to claim 109, wherein the distal tip has a distal outer diameter, and the expandable structure has a maximum width in the collapse configuration that is less than or equal to the proximal outer diameter.

129. A method for treating lesions within the body's tubular lumen, wherein the method is The procedure involves advancing an IVL catheter having a laterally expandable structure including a shock wave emitter assembly through the body lumen, wherein the laterally expandable structure is in a lateral collapse configuration. Positioning the emitter assembly adjacent to the lesion, By extending the laterally expandable structure laterally, the emitter assembly is moved closer to the lesion, The solution is introduced into the emitter assembly through the fluid lumen of the laterally expandable structure, Energy is supplied to the emitter assembly from an energy source connected to the emitter assembly by an energy guide, thereby generating one or more shock waves. Compressing the expandable structure laterally Includes, The catheter comprises a movable shaft and a catheter body having a plurality of lumens, wherein in the lateral expansion configuration, the movable shaft is located more proximal within the first lumen of the plurality of lumens than in the lateral collapse configuration.

130. The method according to claim 129, wherein extending the laterally expandable structure laterally includes moving a movable shaft connected to the expandable structure from a distal position to a proximal position.

131. The method according to claim 129, wherein expanding the laterally expandable structure laterally forms at least one gap for blood to flow beyond the laterally expandable structure within the body lumen.

132. The method according to claim 129, wherein introducing the solution comprises creating a vacuum over the fluid lumen at the proximal end of the fluid lumen, replacing the vacuum with a fluid source, and filling the laterally expandable structure with the solution.

133. The method according to claim 129, wherein introducing the solution fills the laterally expandable inclusion, and the inclusion is configured not to expand when the inclusion is filled with the solution.

134. A method for treating lesions within the body's tubular lumen, wherein the method is The procedure involves advancing an IVL catheter having a laterally expandable structure including a shock wave emitter assembly through the body lumen, wherein the laterally expandable structure is in a lateral collapse configuration. Positioning the emitter assembly adjacent to the lesion, By expanding the laterally expandable structure laterally so that the outer extension member of the laterally expandable structure contacts the lesion, the emitter assembly is moved closer to the lesion. The solution is introduced into the emitter assembly through the fluid lumen of the laterally expandable structure, Energy is supplied to the emitter assembly from an energy source connected to the emitter assembly by an energy guide, thereby generating one or more shock waves. Compressing the expandable structure laterally Methods that include...

135. The method according to claim 134, wherein the outer extension member comprises the fluid tube lumen.

136. The method according to claim 135, wherein the outer extension member is configured not to expand when the outer extension member is filled with the solution.

137. The method according to claim 136, wherein the laterally expandable structure is expanded laterally so that the outer extension member of the laterally expandable structure contacts the lesion, thereby allowing blood to flow beyond the laterally expandable structure within the lumen.

138. A system for treating lesions within the body's tubular lumen, wherein the system is The catheter according to claim 48, A power supply configured to supply power to at least one emitter and generate shock waves for treating the lesion, A system that includes these features.

139. A system for treating lesions within the body's tubular lumen, The catheter according to claim 63, A power supply configured to supply power to at least one emitter and generate shock waves for treating the lesion, A system that includes these features.

140. A system for treating lesions within the body's tubular lumen, The catheter according to claim 95, A power supply configured to supply power to at least one emitter and generate shock waves for treating the lesion, A system that includes these features.

141. A system for treating lesions within the body's tubular lumen, The catheter according to claim 105, A power supply configured to supply power to at least one emitter and generate shock waves for treating the lesion, A system that includes these features.

142. A system for treating lesions within the body's tubular lumen, A catheter according to claim 109, A power supply configured to supply power to at least one emitter and generate shock waves for treating the lesion, A system that includes these features.

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