Energy delivery system

Abstract

Systems, devices, and methods for performing intravascular lithotripsy on a patient are disclosed herein. A system includes a catheter having: an energy delivery core; an energy emitter coupled to the energy delivery core; and a first connector assembly operably attached to the energy delivery core. The system further includes a console having: an energy pulse generator configured to generate an energy pulse; and a second connector assembly configured to operably couple the energy pulse to the energy delivery core. The energy emitter can deliver the energy pulse to a target location that is located proximate to a target material. The energy pulse can generate a pressure wave within the target material. The pressure wave can treat the target material.

Description

[0001] Attorney Docket No. GYT-027-PCT

[0002] ENERGY DELIVERY SYSTEM

[0003] FIELD

[0004]

[0001] The present disclosure relates generally to systems, devices, and methods for generating a pressure wave proximate a target material to be treated.

[0005] BACKGROUND

[0006]

[0002] Coronary artery calcification (CAC), manifested as calcium deposits in the arterial wall, can complicate coronary interventions (e.g. stent implantations) which are meant to restore blood flow to the heart muscle by re-opening vessels that have become restricted due to the various diseases of the coronary arteries, including CAC. Therapeutic methods for treatment of calcium deposits include intravascular lithotripsy (IVL). Systems, devices, and methods for optically produced bubble generation as a mechanism of IVL are desired.

[0007] SUMMARY

[0008]

[0003] The present disclosure results, in one example, from the realization that conventional intravascular lithotripsy systems (which rely on bulky electrodes or mechanical structures to generate pressure waves) are difficult to implement in narrow, tortuous blood vessels, provide limited control over where the therapeutic pressure waves are formed, and are constrained in how quickly they can be actuated, often producing only a limited number of pulses per second (e g., 2 pulses per second). By instead using an optical core and one or more optical emitter structures located near the end of a small-diameter catheter, short pulses of light can be generated and delivered at much higher repetition rates (e.g., 100Hz) and redirected laterally to generate bubbles in or adjacent the vessel wall at precise locations. The expansion and collapse of these bubbles can produce localized pressure waves that fracture calcified plaque while limiting stress on surrounding soft tissue, and the ability to deliver many lower-energy pulses in rapid succession allows the therapeutic contributions of the pulses to accumulate over time, thereby enabling intravascular lithotripsy in narrow, tortuous vessels with improved control over energy delivery.

[0009]

[0004] According to an aspect of the present inventive concepts, a system for performing intravascular lithotripsy on a patient comprises a catheter comprising: an optical energy delivery Attorney Docket No. GYT-027-PCT core; an optical energy emitter coupled to the energy delivery core; and a first connector assembly operably attached to the energy delivery core. The system further comprises a console comprising: an energy pulse generator configured to generate an energy pulse; and a second connector assembly configured to operably couple the energy pulse to the energy delivery core. The energy emitter is configured to deliver the energy pulse to a target location that is located proximate to a target material. The energy pulse is configured to generate a pressure wave within the target material. The pressure wave is configured to treat the target material.

[0010]

[0005] In some embodiments, the catheter comprises a shaft with a diameter of no more than 0.044 inches. The shaft can comprise a diameter of no more than 0.032 inches. The energy delivery core can comprise a diameter of no more than 0.014 inches.

[0011]

[0006] In some embodiments, the pressure wave is configured to generate a peak therapeutic pressure of at least 200atm.

[0012]

[0007] In some embodiments, the energy delivery core comprises an optical core. The optical core can comprise cladding. The optical core can comprise a multi-mode optical fiber. The optical core can comprise a multi-core arrangement of two or more optical fibers.

[0013]

[0008] In some embodiments, the energy delivery core comprises a tubular element surrounding the energy delivery core. The tubular element can comprise a metallization that can be applied to the energy delivery core. The tubular element can comprise a set of patterned reliefs. The set of patterned reliefs can comprise one or more laser-cut reliefs.

[0014]

[0009] In some embodiments, the energy emitter comprises an optical emitter.

[0015]

[0010] In some embodiments, the energy emitter comprises a wedge-based optical emitter comprising a relief. The relief can comprise one or more machined reliefs. The one or more machined reliefs can comprise one or more laser machined reliefs. The one or more laser machined reliefs can comprise one or more pulsed-laser machined reliefs, such as when the reliefs are created using ultrashort pulsed-laser machining. The relief can comprise a depth and an angle, and the depth and the angle of the relief can be configured to control the deflection of one or more energy pulses delivered by the energy emitter. The relief can comprise a metal coating. The relief can be oriented proximally. The relief can be oriented distally. The relief can be constructed and arranged to cause total internal reflection. The relief can be oriented proximally. The catheter can include a shaft and the relief can be created through a window in the shaft. Attorney Docket No. GYT-027-PCT

[0016]

[0011] In some embodiments, the energy emitter comprises a leaky portion of the energy delivery core. The leaky portion can comprise a portion created using an ablating and / or a machining manufacturing process.

[0017]

[0012] In some embodiments, the energy emitter comprises one or more scattering defects of the energy delivery core.

[0018]

[0013] In some embodiments, the energy emitter comprises a lens configured to focus the energy pulse.

[0019]

[0014] In some embodiments, the energy emitter comprises a Bragg grating portion of the energy delivery core. The Bragg grating portion can comprise a portion created with femtosecond laser processing.

[0020]

[0015] In some embodiments, the energy pulse generator is configured to generate multiple energy pulses and the energy emitter is configured to deliver the multiple energy pulses. The energy emitter can be configured to deliver the multiple energy pulses without translating the energy delivery core and / or without rotating the energy delivery core.

[0021]

[0016] In some embodiments, the energy emitter comprises a tapered portion of the energy delivery core. The tapered portion can comprise a narrow taper configured to create a point emission of the energy pulse. The tapered portion can comprise a long taper configured to create a distributed emission of the energy pulse. The tapered portion can be configured to focus the energy pulse into a ring of light. The ring of light can be configured to create a torus-shaped bubble. The tapered portion can comprise a GRIN portion configured to direct or focus the energy pulse. The GRIN portion can be configured to create a point emission of the energy pulse. The GRIN portion can be configured to create at least one ring of light. The GRIN portion can be configured to create multiple rings of light.

[0022]

[0017] In some embodiments, the energy emitter comprises an optical emitter comprising two or more optical emitters. The system can be configured to create multiple simultaneous pressure waves. The system can be configured to treat a longitudinal portion of the target material without rotation and / or without translation of the energy emitter. The two or more optical emitters can be distributed axially along the energy delivery core. The two or more optical emitters can be distributed radially along the energy delivery core.

[0023]

[0018] In some embodiments, the energy pulse comprises one or more pulses of light. Attorney Docket No. GYT-027-PCT

[0024]

[0019] In some embodiments, the energy pulse is configured to generate one or more bubbles, and the one or more bubbles are configured to generate a pressure wave. The one or more bubbles can comprise one or more spherical bubbles. The pressure wave can comprise at least two pressure waves. A first pressure wave can be generated by bubble expansion and a second pressure wave can be generated by bubble collapse. The first pressure wave can be generated by a first energy level and the second pressure wave can be generated by a second energy level, and the first energy level can be greater than the second energy level. The system can be configured to minimize the second pressure wave.

[0025]

[0020] In some embodiments, the console comprises a translation module configured to cause translation of at least the energy emitter.

[0026]

[0021] In some embodiments, the console comprises a rotation module configured to cause rotation of at least the energy emitter.

[0027]

[0022] In some embodiments, the catheter comprises an expandable balloon, and the console comprises a balloon fill assembly configured to deliver flowable material to the expandable balloon, and the expandable balloon is configured as an energy distributor when filled with the flowable material. The balloon fill assembly can include a first sensor comprising a pressure sensor, a flow sensor, and / or other sensor, and the first sensor can be configured to produce a sensor signal, and the balloon fill assembly can be configured to deliver the flowable material to and / or extract the flowable material from the expandable balloon in a closed loop arrangement based on the sensor signal. The first sensor can be located in the expandable balloon. The first sensor can be located in the console. The fill assembly can be configured to maintain constant pressure in the expandable balloon based on the sensor signal. The fill assembly can be configured to monitor changes in pressure in the expandable balloon. The changes in pressure can comprise changes in pressure that result due to calcium fracture. The console can be configured to monitor the expandable balloon via information received from an imaging device. The console can be configured to monitor the size and / or the shape of the expandable balloon. The information can comprise OCT-based imaging information. The catheter can be configured to produce the OCT-based imaging information.

[0028]

[0023] In some embodiments, the console further comprises a contrast delivery assembly.

[0029]

[0024] In some embodiments, the catheter further comprises an energy distributor, such as an expandable balloon configured to distribute energy. The energy distributor can be configured to Attorney Docket No. GYT-027-PCT receive a flowable material, and the flowable material can receive the energy pulse when the energy distributor is positioned proximate the target material. The flowable material can be selected from the group consisting of: indocyanine green dye (ICG); RO contrast; saline; and combinations thereof. The flowable material can comprise one or more materials that can be selected based on the properties of the energy pulse. The properties of the energy pulse can comprise the wavelength of the energy pulse. The flowable material can comprise multiple materials that are delivered to the energy distributor via multiple syringes and / or multiple reservoirs. The energy emitter can be positioned within the energy distributor. The energy distributor can comprise a balloon, such as a cutting balloon. The energy distributor can comprise a treatment element selected from the group consisting of: balloon; cutting balloon; atherectomy element; sharp blade; laser; rotating device; and combinations thereof. The energy distributor can comprise a balloon that is fdled to a target pressure. The target pressure can comprise a pressure of no more than 4atm.

[0030]

[0025] In some embodiments, the catheter comprises a first catheter, and the system further comprises a second catheter configured to slidingly receive the first catheter. The second catheter can comprise a set of catheters with different dimensions and / or other different properties. The different catheter dimensions can comprise different diameters and / or different lengths. The second catheter can comprise a balloon. The first catheter can comprise a diameter of no more than 0.014 inches. The second catheter can be configured to be transluminally advanced over the first catheter.

[0031]

[0026] In some embodiments, the catheter comprises a marker. The marker can comprise a radiopaque marker. The marker can indicate an emission region of the catheter.

[0032]

[0027] In some embodiments, the first connector assembly comprises a self-cleaning connector assembly. The first connector assembly can be configured to clean a surface of the energy delivery core. The energy delivery core can comprise an optical core, and the first connector assembly can be configured to clean an optical connection. The first connector assembly can comprise a wiper configured to clean a surface of the energy delivery core. The first connector assembly can be configured to perform a cleaning operation using a jet of gas. The jet of gas can be created via connecting of the first connector assembly to the energy delivery core. Attorney Docket No. GYT-027-PCT

[0033]

[0028] In some embodiments, the first connector assembly comprises an identifier. The identifier can comprise an RF identifier. The identifier can be configured to record uses, number of energy pulses delivered, and / or calibration information. The system can be configured to monitor total delivered energy. The system can be configured to provide an alert when use of the energy delivery core exceeds a threshold.

[0034]

[0029] In some embodiments, the first connector assembly is configured to removably attach to the energy delivery core. The first connector assembly can comprise a diameter of no more than 0.014 inches.

[0035]

[0030] According to another aspect of the present inventive concepts, a method of performing intravascular lithotripsy on a patient comprises: selecting a system; and generating a pressure wave that is configured to treat target material of the patient.

[0036]

[0031] In some embodiments, the method further comprises: delivering the catheter through a body lumen; positioning the energy emitter proximate the target material; and delivering an energy pulse to a target location. The delivering of the energy pulse can generate the pressure wave.

[0037]

[0032] In some embodiments, the target material comprises calcific plaque and / or one or more other materials associated with the narrowing of a blood vessel.

[0038]

[0033] In some embodiments, the method further comprises delivering an energy pulse to a target location, and the energy pulse creates a bubble that generates the pressure wave. The bubble can comprise a rapidly expanding and / or rapidly collapsing bubble. The pressure wave can comprise a first pressure wave formed by the bubble expanding and a second pressure wave formed by the bubble collapsing. The first pressure wave can comprise more energy than the second pressure wave. The method can further comprise suppressing the second pressure wave. The bubble can comprise a non-symmetric shape. The bubble can comprise a spherical shape. The method can further comprise removing residual microbubbles between a first energy delivery and a second energy delivery. The method can further comprise delivering a second energy pulse to a second target location, and the second energy pulse can create a second bubble that generates a second pressure wave. The second energy pulse can be delivered to the second target location without rotating and / or translating the energy emitter. Attorney Docket No. GYT-027-PCT

[0039]

[0034] The technology described herein, along with the attributes and attendant advantages thereof, will best be appreciated and understood in view of the following detailed description taken in conjunction with the accompanying drawings in which representative embodiments are described by way of example.

[0040] INCORPORATION BY REFERENCE

[0041]

[0035] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. The content of all publications, patents, and patent applications mentioned in this specification are herein incorporated by reference in their entirety for all purposes.

[0042] BRIEF DESCRIPTION OF THE DRAWINGS

[0043]

[0036] Fig. 1 illustrates a block diagram of an embodiment of a system for generating a pressure wave proximate target material within a patient, consistent with the present inventive concepts.

[0044]

[0037] Fig. 1 A illustrates a block diagram of another embodiment of a system for generating a pressure wave proximate target material within a patient, consistent with the present inventive concepts.

[0045]

[0038] Fig. 2 illustrates a flow chart of a method of treating a target material by providing a therapeutic pressure gradient within the target material, consistent with the present inventive concepts.

[0046]

[0039] Fig. 3 illustrates a schematic view of a distal portion of an embodiment of an energy delivery catheter, consistent with the present inventive concepts.

[0047]

[0040] Fig. 4 illustrates a schematic view of a distal portion of an embodiment of an energy delivery catheter, consistent with the present inventive concepts.

[0048]

[0041] Figs. 5 A and 5B illustrate examples of light emission patterns from various embodiments of emitter assemblies, consistent with the present inventive concepts.

[0049]

[0042] Fig. 6 illustrates a photograph of an embodiment of an energy distribution catheter, consistent with the present inventive concepts. Attorney Docket No. GYT-027-PCT

[0050]

[0043] Figs. 7, 7A and 7B illustrate a perspective view of the distal portion of an embodiment of an energy distribution catheter with an energy delivery catheter slidingly positioned therein, and magnified views of the proximal and distal ends of the energy distributor of the energy distribution catheter, respectively, consistent with the present inventive concepts.

[0044] Figs. 8A and 8B illustrate a perspective view of the distal end of an embodiment of an integrated energy delivery catheter and energy distribution catheter, and a perspective view of the distal portion of the shaft of the catheter, respectively, consistent with the present inventive concepts.

[0051]

[0045] Figs. 9A through 9D illustrate perspective views of the distal end of an embodiment of an energy delivery catheter and an energy distribution catheter, the handle of the energy delivery catheter, and the proximal and distal ends of the energy distributor of the energy distribution catheter, respectively, consistent with the present inventive concepts.

[0052]

[0046] Figs. 10A and 10B illustrate side and perspective views of an embodiment of a fiber cap portion of an emitter assembly, respectively, consistent with the present inventive concepts.

[0047] Figs. 11, 11A and 1 IB illustrate a perspective view of an embodiment of an integrated energy delivery catheter and energy distribution catheter, a perspective view of the distal portion of the energy distributor of the catheter, and a perspective view of a portion of the energy delivery core including an emitter assembly, respectively, consistent with the present inventive concepts.

[0053]

[0048] Fig. 12 illustrates a schematic view of an embodiment of a console including multiple pulse generators and the proximal portion of an energy delivery catheter, consistent with the present inventive concepts.

[0054]

[0049] Figs. 13A through 13F illustrate schematic views of various embodiments of an emitter assembly, respectively, consistent with the present inventive concepts.

[0055]

[0050] Figs. 14A through 14C illustrate various arrangements of fiber bundles and emitter assemblies of the fiber bundles, respectively, consistent with the present inventive concepts.

[0051] Fig. 15 illustrates an optical schematic of an optical pathway of an energy delivery system where the optical pathway includes a circulator, consistent with the present inventive concepts.

[0056]

[0052] Fig. 16 illustrates a perspective view of a fiber cap lens assembly, consistent with the present inventive concepts. Attorney Docket No. GYT-027-PCT

[0057] DETAILED DESCRIPTION

[0058]

[0053] Reference will now be made in detail to the present embodiments of the technology, examples of which are illustrated in the accompanying drawings. Similar reference numbers may be used to refer to similar components. However, the description is not intended to limit the present disclosure to particular embodiments, and it should be construed as including various modifications, equivalents, and / or alternatives of the embodiments described herein.

[0059]

[0054] It will be understood that the words "comprising" (and any form of comprising, such as "comprise" and "comprises"), "having" (and any form of having, such as "have" and "has"), "including" (and any form of including, such as "includes" and "include") or "containing" (and any form of containing, such as "contains" and "contain") when used herein, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0060]

[0055] It will be further understood that, although the terms first, second, third, etc. may be used herein to describe various limitations, elements, components, regions, layers and / or sections, these limitations, elements, components, regions, layers and / or sections should not be limited by these terms. These terms are only used to distinguish one limitation, element, component, region, layer or section from another limitation, element, component, region, layer or section. Thus, a first limitation, element, component, region, layer or section discussed below could be termed a second limitation, element, component, region, layer or section without departing from the teachings of the present application.

[0061]

[0056] It will be further understood that when an element (also referred to as a “component” herein) is described as being "on", "attached", "connected" or "coupled" to another element, it can be directly on or above, or connected or coupled to, the other element, or one or more intervening elements can be present. In contrast, when an element is referred to as being "directly on", "directly attached", "directly connected" or "directly coupled" to another element, there are no intervening elements present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g. "between" versus "directly between," "adjacent" versus "directly adjacent," etc.).

[0062]

[0057] As used herein, the terms “operably attached”, “operably connected”, “operatively coupled” and similar terms related to attachment of components shall refer to attachment of two Attorney Docket No. GYT-027-PCT or more components that results in one, two, or more of electrical attachment; fluid attachment; magnetic attachment; mechanical attachment; optical attachment; sonic attachment; and / or other operable attachment arrangements. The operable attachment of two or more components can facilitate the transmission between the two or more components of: power; signals; electrical energy; fluids or other flowable materials; magnetism; mechanical linkages; light; sound such as ultrasound; and / or other materials and / or components.

[0063]

[0058] It will be further understood that when a first element is referred to as being "in", "on" and / or "within" a second element, the first element can be positioned: within an internal space of the second element, within a portion of the second element (e.g. within a wall of the second element); positioned on an external and / or internal surface of the second element; and combinations of one or more of these.

[0064]

[0059] As used herein, the term “proximate”, when used to describe proximity of a first component or location to a second component or location, is to be taken to include one or more locations near to the second component or location, as well as locations in, on and / or within the second component or location. For example, a component positioned proximate an anatomical site (e.g. a blood or other fluid delivery location), shall include components positioned near to the anatomical site, as well as components positioned in, on and / or within the anatomical site.

[0060] Spatially relative terms, such as "beneath," "below," "lower," "above," "upper", “under” and the like may be used to describe an element and / or feature's relationship to another element(s) and / or feature(s) as, for example, illustrated in the figures. It will be further understood that the spatially relative terms are intended to encompass different orientations of the device in use and / or operation in addition to the orientation depicted in the figures. For example, if the device in a figure is turned over, elements described as "below" and / or "beneath" other elements or features would then be oriented "above" the other elements or features. The device can be otherwise oriented (e.g. rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0065]

[0061] The terms “reduce”, “reducing”, “reduction” and the like, where used herein, are to include a reduction in a quantity, including a reduction to zero. Reducing the likelihood of an occurrence shall include prevention of the occurrence. Correspondingly, the terms “prevent”, “preventing”, and “prevention” shall include the acts of “reduce”, “reducing”, and “reduction”, respectively. Attorney Docket No. GYT-027-PCT

[0066]

[0062] The term "and / or" where used herein is to be taken as specific disclosure of each of the two specified features or components with or without the other. For example "A and / or B" is to be taken as specific disclosure of each of (i) A, (ii) B and (iii) A and B, just as if each is set out individually herein.

[0067]

[0063] The term “one or more”, where used herein can mean one, two, three, four, five, six, seven, eight, nine, ten, or more, up to any number.

[0068]

[0064] The terms “and combinations thereof’ and “and combinations of these” can each be used herein after a list of items that are to be included singly or collectively. For example, a component, process, and / or other item selected from the group consisting of A; B; C; and combinations thereof, shall include a set of one or more components that comprise: one, two, three or more of item A; one, two, three or more of item B; and / or one, two, three, or more of item C.

[0069]

[0065] In this specification, unless explicitly stated otherwise, “and” can mean “or”, and “or” can mean “and”. For example, if a feature is described as having A, B, or C, the feature can have

[0070] A, B, and C, or any combination of A, B, and C. Similarly, if a feature is described as having A,

[0071] B, and C, the feature can have only one or two of A, B, or C.

[0072]

[0066] As used herein, when a quantifiable parameter is described as having a value “between” a first value X and a second value Y, it shall include the parameter having a value of: at least X, no more than Y, and / or at least X and no more than Y. For example, a length of between 1 and 10 shall include a length of at least 1 (including values greater than 10), a length of less than 10 (including values less than 1), and / or values greater than 1 and less than 10.

[0073]

[0067] The expression “configured (or set) to” used in the present disclosure may be used interchangeably with, for example, the expressions “suitable for”, “having the capacity to”, “designed to”, “adapted to”, “made to” and “capable of’ according to a situation. The expression “configured (or set) to” does not mean only “specifically designed to” in hardware.

[0074] Alternatively, in some situations, the expression “a device configured to” may mean that the device “can” operate together with another device or component.

[0075]

[0068] As used herein, the terms “about” or “approximately” shall refer to ± 20% of a stated value.

[0076]

[0069] As used herein, the term “threshold” refers to a maximum level, a minimum level, and / or range of values correlating to a desired or undesired state. In some embodiments, a Attorney Docket No. GYT-027-PCT system parameter is maintained above a minimum threshold, below a maximum threshold, within a threshold range of values, and / or outside a threshold range of values, such as to cause a desired effect (e.g. efficacious therapy) and / or to prevent or otherwise reduce (hereinafter “prevent”) an undesired event (e.g. a device and / or clinical adverse event). In some embodiments, a system parameter is maintained above a first threshold (e.g. above a first temperature threshold to cause a desired therapeutic effect to tissue) and below a second threshold (e.g. below a second temperature threshold to prevent undesired tissue damage). In some embodiments, a threshold value is determined to include a safety margin, such as to account for patient, user, and / or operator variability, system variability, tolerances, and the like. As used herein, “exceeding a threshold” relates to a parameter going above a maximum threshold, below a minimum threshold, within a range of threshold values and / or outside of a range of threshold values.

[0077]

[0070] As described herein, “room pressure” shall mean pressure of the environment surrounding the systems and devices of the present inventive concepts. Positive pressure includes pressure above room pressure or simply a pressure that is greater than another pressure, such as a positive differential pressure across a fluid pathway component such as a valve. Negative pressure includes pressure below room pressure or a pressure that is less than another pressure, such as a negative differential pressure across a fluid component pathway such as a valve. Negative pressure can include a vacuum but does not imply a pressure below a vacuum. As used herein, the term “vacuum” can be used to refer to a full or partial vacuum, or any negative pressure as described hereabove.

[0078]

[0071] The term “diameter” where used herein to describe a non-circular geometry is to be taken as the diameter of a hypothetical circle approximating the geometry being described. For example, when describing a cross section, such as the cross section of a component, the term “diameter” shall be taken to represent the diameter of a hypothetical circle with the same cross sectional area as the cross section of the component being described.

[0079]

[0072] The terms “major axis” and “minor axis” of a component where used herein are the length and diameter, respectively, of the smallest volume hypothetical cylinder which can completely surround the component.

[0080]

[0073] As used herein, the term “functional element” is to be taken to include one or more elements constructed and arranged to perform a function. A functional element can comprise a Attorney Docket No. GYT-027-PCT sensor and / or a transducer. In some embodiments, a functional element is configured to deliver energy. In some embodiments, a functional element is configured to treat tissue (e.g. a functional element configured as a treatment element). Alternatively or additionally, a functional element (e.g. a functional element comprising a sensor) can be configured to record one or more parameters, such as a patient physiologic parameter; a patient anatomical parameter (e.g. a tissue geometry parameter); a patient environment parameter; and / or a system parameter. In some embodiments, a sensor or other functional element is configured to perform a diagnostic function (e g. to gather data used to perform a diagnosis). In some embodiments, a functional element is configured to perform a therapeutic function (e.g. to deliver therapeutic energy and / or a therapeutic agent). In some embodiments, a functional element comprises one or more elements constructed and arranged to perform a function selected from the group consisting of: deliver energy; extract energy (e.g. to cool a component); deliver a drug or other agent; manipulate a system component or patient tissue; record or otherwise sense a parameter such as a patient physiologic parameter or a system parameter; and combinations of one or more of these. A functional element can comprise a fluid and / or a fluid delivery system. A functional element can comprise a reservoir, such as an expandable balloon or other fluid-maintaining reservoir. A “functional assembly” can comprise an assembly constructed and arranged to perform a function, such as a diagnostic and / or therapeutic function. A functional assembly can comprise an expandable assembly. A functional assembly can comprise one or more functional elements.

[0074] The term “transducer” where used herein is to be taken to include any component or combination of components that receives energy or any input, and produces an output. For example, a transducer can include an electrode that receives electrical energy, and distributes the electrical energy to tissue (e.g. based on the size of the electrode). In some configurations, a transducer converts an electrical signal into any output, such as: light (e.g. a transducer comprising a light emitting diode or light bulb), sound (e.g. a transducer comprising a piezo crystal configured to deliver ultrasound energy); pressure (e.g. an applied pressure or force); heat energy; cryogenic energy; chemical energy; mechanical energy (e g. a transducer comprising a motor or a solenoid); magnetic energy; and / or a different electrical signal (e.g. different than the input signal to the transducer). Alternatively or additionally, a transducer can convert a physical quantity (e.g. variations in a physical quantity) into an electrical signal. A transducer can include any component that delivers energy and / or an agent to tissue, such as a transducer configured to Attorney Docket No. GYT-027-PCT deliver one or more of: electrical energy to tissue (e.g. a transducer comprising one or more electrodes); light energy to tissue (e.g. a transducer comprising a laser, light emitting diode and / or optical component such as a lens or prism); mechanical energy to tissue (e.g. a transducer comprising a tissue manipulating element); sound energy to tissue (e.g. a transducer comprising a piezo crystal); chemical energy; electromagnetic energy; magnetic energy; and combinations of one or more of these.

[0081]

[0075] As used herein, the term “fluid” can refer to a liquid, gas, gel, or any flowable material, such as a material which can be propelled through a lumen and / or opening.

[0082]

[0076] As used herein, the term “material” can refer to a single material, or a combination of two, three, four, or more materials.

[0083]

[0077] As used herein, the term “user interface” can comprise one or more interfaces, each interface comprising one or more components configured to receive an input from a user, “user input device” herein, and / or one or more components configured to provide output to a user, “user output device” herein. An input device can comprise one, two, three, or more components selected from the group consisting of keyboard; a mouse; a button; a switch; a lever; a keypad such as a membrane keypad; a joystick; a touchscreen display; a microphone; a brain-machine- interface (e.g., a thought-control device); a camera, such as a camera with eye tracking, motion tracking, gesture identification, and / or other image processing capability configured to identify user input; a motion capture device, such as a camera and / or a device including one or more accelerometers; a virtual input device, such as a virtual device comprising ultrasonic, image capture, and / or motion-based sensing of user inputs; a physiologic input sensor, such as a sensor configured to provide an input signal based on a user action, such as flexure of a muscle proximate the sensor; a scent detector, such as a detector configured to identify a pheromone or other scent produced by the user; other input component; and combinations of these. An output device can comprise one, two, three, or more components selected from the group consisting of: a visual output component such as a light and / or a display such as a touchscreen display; an audible output component such as a buzzer and / or a speaker; a haptic output component such as a vibrational transducer and / or an ultrasonic device configured to produce a tactile output; a brain-machine-interface; an augmented reality (AR) and / or a virtual reality (VR) output device, such as glasses or a headset including a non-transparent display, a transparent display, and / or a “heads up” display where information is presented to the user in an overlay manner; a scent Attorney Docket No. GYT-027-PCT output device configured to produce an aromatic output, such as a computerized scent output; other output component; and combinations of these.

[0084]

[0078] The terms “data” and “information” are used interchangeably herein.

[0085]

[0079] As used herein, the term “access” can refer to providing access to a location within a patient for delivery of fluids or other materials, and / or removal of fluids or other materials.

[0086]

[0080] As used herein, a “blood vessel of an organ” can comprise a blood vessel that supplies blood to the organ, such as an artery that supplies blood to the organ, a blood vessel on or within the organ, such as an artery, vein, and / or capillary within the organ, and / or a blood vessel that receives blood from the organ, such as a vein that receives blood from the organ.

[0087]

[0081] It is appreciated that certain features of the inventive concepts, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the inventive concepts which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. For example, it will be appreciated that all features set out in any of the claims (whether independent or dependent) can be combined in any given way.

[0088]

[0082] It is to be understood that at least some of the figures and descriptions of the inventive concepts have been simplified to focus on elements that are relevant for a clear understanding of the inventive concepts, while eliminating, for purposes of clarity, other elements that those of ordinary skill in the art will appreciate may also comprise a portion of the inventive concepts. However, because such elements are well known in the art, and because they do not necessarily facilitate a better understanding of the inventive concepts, a description of such elements is not provided herein.

[0089]

[0083] Terms defined in the present disclosure are only used for describing specific embodiments of the present disclosure and are not intended to limit the scope of the present disclosure. Terms provided in singular forms are intended to include plural forms as well, unless the context clearly indicates otherwise. All of the terms used herein, including technical or scientific terms, have the same meanings as those generally understood by an ordinary person skilled in the related art, unless otherwise defined herein. Terms defined in a generally used dictionary should be interpreted as having meanings that are the same as or similar to the contextual meanings of the relevant technology and should not be interpreted as having ideal or exaggerated meanings, unless expressly so defined herein. In some cases, terms defined in the Attorney Docket No. GYT-027-PCT present disclosure should not be interpreted to exclude the embodiments of the present disclosure.

[0090]

[0084] Referring now to Fig. 1, a block diagram of an embodiment of a system for generating a pressure wave proximate target material within a patient is illustrated, consistent with the present inventive concepts. System 10 can be configured to generate one or more pressure waves, pressure wave PW, each configured to induce a therapeutic pressure gradient, pressure gradient TPG, within “target material”, where pressure gradient TPG is configured to disrupt, reshape, remove, fracture, pulverize, alter, and / or otherwise treat (“treat” herein) the target material (e.g., calcific plaque and / or one or more other materials associated with the narrowing of a blood vessel). For example, system 10 can be configured to generate a series of pressure waves PW proximate target material comprising a coronary artery calcification (CAC), where the series of pressure waves PW induces one or more pressure gradients TPG within the calcification that are configured to treat the calcification, as described herein. In some embodiments, system 10 is configured to avoid inducing a pressure gradient TPG within and / or proximate “non-target material”, such as non-target tissue or other non-target material to which a pressure gradient TPG could cause an unwanted change (e.g., injure tissue of the non-target material). As used herein, pressure gradient TPG can comprise a pressure gradient that is above a threshold, such as a threshold below which a target material and / or a non-target material is not significantly affected (e.g., not negatively and / or positively affected). As described herein, system 10 can be configured to provide an intravascular lithotripsy (IVL) based treatment of a target material, such as laser-based IVL.

[0091]

[0085] System 10 includes one or more catheters for delivering energy proximate a target material, energy delivery catheter 100 shown. Energy delivery catheter 100 can include one or more energy transmission conduits, energy delivery core 110 shown, that comprises an elongate conduit extending from a proximal end 111 to a distal end 119. Energy delivery core 110 includes distal portion 118 shown. Energy delivery core 110 can include one or more energy output and / or focusing components, emitter assembly 115.

[0092]

[0086] System 10 can include one or more consoles, console 300 shown. Console 300 can be configured to operably connect to energy delivery catheter 100, such as to transfer energy from console 300 to energy delivery catheter 100, as described herein. Console 300 can one or more treatment energy generators, energy pulse generator 310 shown. Energy pulse generator Attorney Docket No. GYT-027-PCT

[0093] 310 can be configured to generate one or more energy pulses, pulse 315 shown, that are configured to cause the formation of a pressure wave PW when delivered to a “target location”, a location that is proximate a target material to be treated. In some embodiments, emitter assembly 115 is configured to focus, emit, and / or otherwise deliver (“deliver” herein) pulse 315 to the target location, such that a pressure wave PW is formed within the target location, as described herein. Pressure wave PW comprises peak pressure PK that is defined as the peak pressure of pressure wave PW at the origination location of pressure wave PW. Pressure wave PW comprises peak therapeutic pressure PKT that is defined as the peak pressure of pressure wave PW where the wave first propagates through a target material. Peak therapeutic pressure PKT also defines the maximum gradient TGP that is generated within a target material by a pressure wave PW. In some embodiments, peak therapeutic pressure PKT comprises a pressure of at least 200atm.

[0094]

[0087] In some embodiments, the target location comprises a location within a natural body lumen of a patient, for example, a vessel, such as an artery or a vein. Target material can comprise tissue and / or other material located within and / or of the body lumen, such as within a vessel wall and / or within the vessel lumen, such as calcification located within an artery (e.g., CAC, as described herein). Energy delivery catheter 100 and / or other devices of system 10 can be introduced through one or more natural body lumens (e.g., introduced intravascularly through a vascular access device) such that emitter assembly 115 can be positioned proximate a target material using standard interventional techniques. Alternatively, or additionally, emitter assembly 115 can be positioned proximate a target material surgically and / or using other invasive or minimally invasive techniques. Alternatively or additionally, emitter assembly 115 can be positioned on the skin of the patient, proximate a target material within the patient (e.g., when pulse 315 is configured to be delivered through the skin of the patient to a target location).

[0088] In some embodiments, pulse 315 is configured to generate one or more bubbles (e.g., one or more vapor bubbles) within a target location, bubble BV or bubbles BV herein. Rapid expansion and / or collapse of these bubbles can induce pressure waves PW within the target location, which result in pressure gradients TPG within the target material proximate the target location (e.g., as the induced pressure waves PW propagate from the bubble location, through the target material). System 10 can include a medium for receiving pulse 315 and the formation of bubbles BV in response to pulse 315, compound 20. Compound 20 can include one or more Attorney Docket No. GYT-027-PCT materials, such as one or more fluids that are positioned within the target location and are configured to absorb or otherwise react to pulse 315, resulting in one or more pressure waves PW, as described herein. As used herein, the generation and / or formation of one or more “bubbles” (e.g., bubbles BV) should be understood to include the generation of one or more rapidly expanding and / or rapidly collapsing bubbles (e.g., vapor bubbles formed within a liquid medium, such as compound 20), where the expansion and / or collapse of the bubbles causes one or more pressure waves PW to be generated. In some embodiments, system 10 is configured to position compound 20 within the target location. System 10 can comprise energy distribution catheter 200, which can be configured to position compound 20 within a target location, such that a pressure wave PW generated by a bubble BV within compound 20 propagates from the target location (e.g., a target location within a portion of energy distribution catheter 200) into the target material. Energy delivery catheter 200 can include one or more energy distribution elements, distributor 210. Distributor 210 can comprise an inflatable balloon, such as a balloon that is configured to receive compound 20 (e.g., to be inflated with compound 20). Pulse 315 can be delivered to a target location within distributor 210 (e.g., to compound 20 within distributor 210), such that bubbles BV formed within compound 20 generate pressure waves PW that propagate through distributor 210 and into a target material.

[0095]

[0089] In some embodiments, console 300 includes an assembly for controlling the inflation and / or deflation of distributor 210, fill assembly 320. Fill assembly 320 can deliver and / or remove compound 20 to and / or from distributor 210, such as to inflate and / or deflate a balloon of distributor 210. In some embodiments, fill assembly 320 is configured to control the pressure of compound 20 within distributor 210 (e.g., in a closed-loop arrangement), as described herein.

[0090] In some embodiments, system 10 is configured to manipulate the position and / or orientation of emitter assembly 115 relative to a target material and / or a target location. System 10 can include kinetic assembly 400 that can be configured to rotate and / or translate emitter assembly 115, such as to rotate and / or retract emitter assembly 115 during a treatment step and / or other step of a process of system 10, as described herein. In some embodiments, one or more portions of kinetic assembly 400 are integrated into console 300, and / or one or more portions of kinetic assembly 400 are separate (e.g., comprise separate housings) from console 300. Attorney Docket No. GYT-027-PCT

[0096]

[0091] System 10 can be configured to treat a medical condition of a patient (e.g., treat a target material of a patient), such as a human, other mammalian, and / or non-mammalian patient, “patient” herein. Additionally, or alternatively, system 10 can be configured to diagnose a medical condition of a patient, for example by imaging a target material and / or a target location, such as when a catheter of system 10 (e.g., energy delivery catheter 100) is configured to perform OCT imaging, as described herein. System 10 can be operated by a doctor, nurse, and / or other healthcare professional, referred to herein as an “operator” of system 10.

[0097]

[0092] System 10 of Fig. 1 can include similar components and can otherwise be of similar construction and arrangement to system 10 described in reference to Fig. 1A and / or other figures described herein.

[0098]

[0093] System 10 can include one or more functional elements, such as functional element 99 shown. One or more components of system 10, such as energy delivery catheter 100, energy distribution catheter 200, console 300, and / or kinetic assembly 400 can each include a functional element 99, such as when functional elements 199, 299, 399, and / or 499, respectively, each shown, comprise a functional element 99, respectively. Singly or collectively, various functional elements described herein can individually or collectively be referred to as “functional element 99”. Functional element 99 (e.g., functional element 99, 199, 299, 399, and / or 499) can comprise one or more sensors, one or more transducers, or both. Functional element 99 can comprise one or more assemblies configured to perform a function (“functional assembly” herein). Functional element 99 can comprise one or more physiologic sensors configured to measure a physiologic parameter of the patient, an operator of system 10, or both. Functional element 99 can comprise one, two, or more physiologic sensors selected from the group consisting of: blood pressure sensor; blood flow sensor; heart rate sensor; blood glucose sensor; blood gas sensor; tissue temperature sensor; and combinations of these. Functional element 99 can comprise a sensor configured to produce a signal related to the environment (e.g., the environment of the patient during a procedure performed using system 10), such as one, two, or more sensors selected from the group consisting of: temperature sensor; humidity sensor; atmospheric pressure sensor; room light sensor; a sound sensor (e.g., a microphone and / or an ultrasound transducer); GPS sensor; and combinations of these. Functional element 99 can comprise one, two, or more sensors selected from the group consisting of: pressure sensor; strain gauge; temperature sensor; flow sensor; accelerometer; and combinations of these. Functional Attorney Docket No. GYT-027-PCT element 99 can comprise one, two, or more transducers selected from the group consisting of: a heating transducer; a cooling transducer; a Peltier element; a thermoelectric element; a vibrational transducer; a vacuum-providing element; a light-producing element; a sound producing element (e.g. a speaker and / or an ultrasound transducer); and combinations of these.

[0099]

[0094] Referring additionally to Fig. 1 A, a block diagram of an embodiment of a system for generating a pressure wave proximate a target material within a patient is illustrated, consistent with the present inventive concepts. In some embodiments, one or more components of system 10 of Fig. 1 A are of similar construction and arrangement to the similar components described in reference to Fig. 1 and / or otherwise herein.

[0100]

[0095] System 10 can include one or more data processing modules, processing unit 50 shown, which can be configured to perform, control, and / or monitor one or more of the functions of system 10 (e.g., as described herein). For example, processing unit 50 can be configured to perform and / or facilitate one or more processes, data collections, data analyses, data transfers, signal processing functions, energy deliveries, positioning of elements, monitoring of one or more patient parameters, and / or other functions of system 10 (“functions of system 10”, “system 10 functions” or simply “system functions” herein). Processing unit 50 can comprise one or more electronic elements, electronic assemblies, and / or other electronic components, such as components selected from the group consisting of: microprocessors; microcontrollers; state machines; memory storage components; analog-to-digital converters; rectification circuitry; filters and other signal conditioners; sensor interface circuitry; transducer interface circuitry; and combinations of one, two, or more of these. For example, processing unit 50 can include at least one processor and at least one memory storage component, such as processor 51 and memory 52, each shown. Memory 52 can be coupled to processor 51, and memory 52 can store one or more sets of computer instructions, instructions 53 shown. Instructions 53 can comprise instructions used by processor 51 to perform one or more algorithms of system 10. For example, system 10 can comprise one or more algorithms, algorithm 55 shown, that are performed by processor 51. Additionally, or alternatively, instructions 53 can comprise instructions for running one or more applications of system 10, for example application 56 shown. Processing unit 50 can be configured to “run” application 56, such that application 56 can initiate, modify, stop, and / or otherwise control the performance of various functions of energy delivery device 100 and / or of Attorney Docket No. GYT-027-PCT other components system 10. In some embodiments, application 56 is configured to receive input from a user of system 10, for example via a user interface (e.g., user interface 60 described herein). In some embodiments, algorithm 55 can comprise one or more machine learning, neural net, and / or other artificial intelligence algorithms (“Al algorithm” herein). All or a portion of one or more processing units 50 can be integrated into one, two, or more of the various components of system 10, such as energy delivery catheter 100, console 300, a server (e.g., server 80 described herein), and / or other components of system 10. Performance of a function of system 10 is described hereabove as being performed by processing unit 50. Alternatively, or additionally, the performance of a function of system 10 can be described herein, interchangeably, as being performed by algorithm 55 and / or system 10. For example, “algorithm 55 being configured to perform an action, a routine, and / or another function” can be interpreted as processing unit 50 and / or system 10 being configured to perform the action, routine, and / or other function, and vice versa.

[0101]

[0096] System 10 can include one or more user interfaces, user interface 60 shown. User interface 60 can provide and / or receive information to and / or from an operator of the system (e g., a doctor and / or other user of system 10). User interface 60 can include one or more user input components and / or output components. For example, user interface 60 can comprise a keyboard, mouse, touchscreen, and / or other human interface and / or other input component (e.g., as described herein), user input device 61. In some embodiments, user interface 60 comprises a speaker, indicator light, haptic transducer and / or other human interface and / or other output component (e.g., as described herein), user output device 62. In some embodiments, user output device 62 comprises a video output component, such as display 63 shown. Display 63 can comprise a touchscreen display, for example when user input device 61 and user output device 62 collectively comprise display 63. In some embodiments, processing unit 50 is configured to provide an interactive graphical interface, GUI 65, such as a graphical user interface provided by application 56. GUI 65 can be displayed (e.g., displayed to a user of system 10) via display 63. In some embodiments, user interface 60 and / or GUI 65 comprise a virtual reality and / or augmented reality interface. One or more components of system 10 can comprise one or more portions of a user interface 60, such as energy delivery catheter 100, energy distribution catheter 200, console 300, kinetic assembly 400, and / or other components of system 10 described herein. Attorney Docket No. GYT-027-PCT

[0102]

[0097] System 10 can include one or more communication modules, communication module 70 shown. One or more devices of system 10 can comprise one or more portions of a communication module 70, such as energy delivery catheter 100, energy distribution catheter 200, console 300, kinetic assembly 400, and / or other components of system 10 described herein. Communication module 70 can be configured to provide communication between (e.g., transfer commands, delivery information, patient information, and / or other data between) two or more components of system 10, such as via wired and / or wireless communication. For example, communication module 70 can include one or more transmitters and / or receivers, transceiver 71 shown. Transceiver 71 can comprise a wireless transceiver, such as a Bluetooth transceiver, a Near Field Communication (NFC) transceiver, a Wi-Fi transceiver, a cellular transceiver, a satellite-connected transceiver, and / or other short-range and / or long-range wireless transceiver. A wireless connection can include a short-range wireless connection, such as an NFC connection and / or a Bluetooth low energy (BLE) connection. In some embodiments, communication module 70 is configured to transfer data via an acoustic signal, such as an acoustic signal that is outside of the auditory range of the user. In some embodiments, communication module 70 is configured to communicate via one or more wired and / or wireless networks, such as network 75 shown. Network 75 can include a wireless network, such as a cellular network, LAN, WAN, VPN, the Internet, and / or other wireless network connecting two or more devices. In some embodiments, network 75 comprises a wired network, and / or a network including wired and wireless devices.

[0103]

[0098] Communication module 70 can be configured to transfer data between at least a first component of system 10 and at least a second component of system 10, as described herein. In some embodiments, the first component of system 10 comprises energy delivery catheter 100. The second component can comprise another component of system 10, for example console 300.

[0099] In some embodiments, console 300 includes at least a portion of processing unit 50, at least a portion of user interface 60, and / or at least a portion of communication module 70, such as when console 300 comprises processing unit 305, user interface 306, and / or communication module 307, respectively, each shown. Console 300 can provide a user interface, user interface 306, for the input of commands and / or other information from an operator of system 10, and / or for the output of information from system 10 to the operator. Console 300 can comprise and / or be operably attached to a display, such as display 63 that is configured to display GUI 65. Attorney Docket No. GYT-027-PCT

[0104] Energy delivery catheter 100, energy distribution catheter 200, and / or kinetic assembly 400 can each include a portion of processing unit 50, user interface 60, and / or communication module 70, for example user interfaces 106, 206, and / or 406, each shown.

[0105]

[0100] In some embodiments, system 10 includes one or more servers, server 80 shown, that can be configured to provide data storage and / or data processing for the providers of system 10 (e.g., the manufacturer and / or distributor of system 10) and / or the users of system 10 (e.g., operators and / or patients of system 10). As used herein, data processing can refer to the receiving of data, processing of data, transmission of data (e.g., transmitting the results of data processing), and / or the storage of data, such as data received from multiple consoles 300 located at multiple clinical sites. Server 80 can comprise one or more processing units 50. Additionally, or alternatively, server 80 can include one or more data storage units for storing data collected by system 10, data 85 shown. In some embodiments, server 80 is configured to process data from various users of system 10, for example when the provider of system 10 maintains one or more servers 80 configured to process data for each (and / or a subset) of the users of system 10 (e.g., each of the patients and / or operators of system 10). Server 80 can comprise an “off-site” server (e.g., remotely located from the users of system 10), such as a server owned, maintained, and / or otherwise provided by the provider of system 10.

[0106] Alternatively, or additionally, server 80 can comprise a cloud-based server.

[0107]

[0101] In some embodiments, at least a portion of system 10 comprises a temporary use component (e.g., limited use component) and / or disposable component (e.g., single use component), either referred to as “disposable” herein. For example, energy delivery catheter 100 can be a disposable device, and / or energy delivery catheter 100 can include one or more disposable portions, each disposable portion configured to be used for a limited number of uses (e.g., for use in a single clinical procedure), and then to be replaced. In some embodiments, system 10 comprises one or more single use disposable components, and / or multi-use (“reusable” and / or “multi-use” herein) disposable components, wherein the multi-use reusable components (e.g., all or a portion of a device, assembly or other component) are transferred at least from a first component of system 10 (e.g., a first energy delivery catheter 100) to a second component of system 10 (e.g., a second energy delivery catheter 100). In some embodiments, a multi-use disposable component is transferred to a third system 10 component (e.g., an energy delivery catheter 100), and so on, but the transfers are limited to a maximum (e.g., two, three, or Attorney Docket No. GYT-027-PCT four transfers). Additionally, or alternatively, system 10 can comprise one or more single and / or multi-use disposable components that are configured to be used for a maximum time period (e.g., as included in one, two, or more energy delivery catheters 100 or other system 10 component), and / or for another maximum usage parameter (e.g., maximum energy delivered via energy delivery catheter 100). For example, energy delivery catheter 100 or other components of system 10 can comprise a first portion that is configured to be used for a first maximum of a usage parameter, and a second portion that is configured to be used for a second maximum of a usage parameter, where the second maximum is less than the first maximum, such as when the first portion is configured to work with two or more second portions (e.g., as the second portion is replaced). In some embodiments, a reusable portion of system 10 comprises at least a portion of a connector assembly (as described herein), kinetic assembly 400, energy distribution catheter 200, and / or console 300. In some embodiments, one or more reusable portions of system 10 can be cleanable and / or sterilizable between uses.

[0108]

[0102] In some embodiments, various components of system 10 are packaged separately, for example higher cost components can be packaged (e.g., and sold) in a first package, and lower cost components can be packaged separately, for example such that lower cost components can be replaced without purchasing additional higher cost components. For example, energy distribution catheter 200 (a low-cost component) can be packaged separately from energy delivery catheter 100 and / or other components of system 10 (such as one or more cables, connectors, and / or compound 20), such that if energy distributor 210 breaks or otherwise fails during a procedure (e.g., if an energy distributor 210 comprising a balloon ruptures during a procedure), the broken catheter can be replaced (e.g., at a lower cost than replacing both energy distribution catheter 200 and energy delivery catheter 100 or a combination catheter comprising both energy delivery catheter 100 and energy distribution catheter 200).

[0109]

[0103] System 10 can include one or more sensors and / or sensor assemblies, such as sensor assembly 30 comprising sensor 35, each shown. All or a portion of one or more sensor assemblies 30 can be integrated into one or more components of system 10, for example sensor assembly 180 of energy delivery catheter 100, sensor assembly 280 of energy distribution catheter 200, and / or sensor assembly 480 of kinetic assembly 400, each including one or more sensors 35. Attorney Docket No. GYT-027-PCT

[0110]

[0104] In some embodiments, processing unit 50 of system 10 can be configured to receive and analyze a signal provided by a sensor 35 and / or sensor assembly 30. For example, processing unit 50 can be configured to analyze a received signal by executing algorithm 55 via processor 51. One or more parameters of system 10 can be adjusted in a closed loop arrangement, as described herein, for example based on the analysis of a sensor signal performed by processing unit 50.

[0111]

[0105] As described herein, energy delivery catheter 100 can comprise energy delivery core 110 shown. Energy delivery core 110 can comprise one or more conduits for transferring energy through energy delivery catheter 100. In some embodiments, for example when pulse 315 comprises one or more pulses of light (as described herein), energy delivery core 110 comprises one or more optical cores, such as one or more optical fibers. For example, energy delivery core 110 can comprise a single-mode optical fiber, multi-mode optical fiber, and / or a multi-core arrangement of two or more optical fibers. In some embodiments, one or more optical fibers of energy delivery core 110 comprise an optical cladding. Energy delivery catheter 100 can include one or more tubular elements surrounding the one or more conduits of energy delivery core 110, shaft 120 shown. In some embodiments, shaft 120 comprises a metallization that is applied onto energy delivery core 110. Shaft 120 can comprise one or more physical relief patterns (e.g., reliefs or other cuts in shaft 120), such as patterned reliefs arranged to improve the flexibility of one or more portions of energy delivery catheter 100. In some embodiments, shaft 120 includes one or more laser-cut reliefs.

[0112]

[0106] Emitter assembly 115 can comprise one or more features of energy delivery core 110 and / or elements coupled to energy delivery core 110 that are configured to direct pulse 315 from energy delivery core 110 to a target location. For example, when pulse 315 comprises one or more pulses of light, emitter assembly 115 can comprise one or more optical lens elements or other “optical emitters” (e.g., one, two, or more optical emitters) that are configured to focus and / or otherwise deliver pulse 315 to the target location. In some embodiments, emitter assembly 115 comprises one or more reliefs (e.g., channels, cuts, recesses, and / or other reliefs) that are formed within energy delivery core 110 and configured to direct pulse 315 toward a target location, for example as described in reference to Fig. 3 and otherwise herein. Attorney Docket No. GYT-027-PCT

[0113]

[0107] In some embodiments, emitter assembly 115 comprises a “leaky” portion of energy delivery core 110, such as a first portion of energy delivery core 110 that is configured to allow at least a portion of pulse 315 to be delivered to a target location via the first portion of energy delivery core 110. In some embodiments, a portion of energy delivery core 110 is treated (e.g., in a manufacturing process, such as a manufacturing process in which a portion of core 110 is ablated or machined) such as to create a leaky portion of emitter assembly 115.

[0114]

[0108] In some embodiments, emitter assembly 115 comprises a portion of energy delivery core 110 that is configured to scatter pulse 315, such as when pulse 315 comprises one or more pulses of light that are scattered by emitter assembly 115 to be delivered to a target location. For example, an energy delivery core 110 comprising one or more optical fibers can comprise one or more scattering features (e.g., defects) that are configured to scatter pulse 315.

[0115]

[0109] In some embodiments, emitter assembly 115 comprises a portion of energy delivery core 110 that is configured to direct pulse 315 toward a target location, for example a portion of an optical fiber including a Bragg grating. In some embodiments, a Bragg grating portion of energy delivery core 110 is created (e.g., in a manufacturing process) with laser processing of an optical fiber, such as femtosecond laser processing.

[0116]

[0110] In some embodiments, emitter assembly 115 comprises a shaped portion of energy delivery core 110, such as a tapered distal portion 118 of energy delivery core 110. For example, energy delivery core 110 can comprise an optical fiber including a tapered distal portion configured to deliver pulse 315 to a target location. Emitter assembly 115 can comprise a tapered portion of energy delivery core 110 as described in reference to Fig. 4 and otherwise herein. In some embodiments, the target location comprises a torus-like volume surrounding a portion of energy delivery core 110.

[0117]

[0111] In some embodiments, emitter assembly 115 comprises an array of two or more emitters, such as two or more emitters configured to each simultaneously deliver a portion of one or more pulses 315 to a unique target location (e.g., to at least a first target location and a second target location). Energy delivery catheter 100 can be configured to generate two or more simultaneous pressure waves PW, such as a first pressure wave PW originating at a first target location and a second pressure wave PW originating at a second target location. The first and second pressure waves PW can create pressure gradients TPG within a longitudinal portion of a target material and / or within a circumferential portion of a target material, such as when emitter Attorney Docket No. GYT-027-PCT assembly 1 15 comprises multiple emitters positioned about a portion of energy delivery core 110 at different axial positions (also referred to as longitudinal orientations) and / or at different angular orientations (also referred to as radial orientations). The emitters of emitter assembly 115 can be configured to deliver pulse 315 to target locations that are located at different angular positions about a portion of energy delivery catheter 100 and / or at different axial locations along a portion of energy delivery catheter 100, such as without translation and / or without rotation of emitter assembly 115. Alternatively, or additionally, kinetic assembly 400 can be configured to rotationally and / or longitudinally (i.e., axially) adjust the position and / or angular orientation of emitter assembly 115, such as to deliver two or more simultaneous and / or sequential pulses 315 to target locations that are located at different angular and / or axial locations about a portion of energy delivery catheter 100. One or more pressure waves PW generated from a longitudinal and / or angular array of target locations (e.g., simultaneously and / or sequentially, as described herein) can generate pressure gradients TPG within longitudinal and / or circumferential segments of a target material, such as to treat longitudinal and / or circumferential segments of a target material, as described herein.

[0118]

[0112] Energy pulse generator 310 of console 300 can be configured to generate pulses 315 that are configured to be delivered to a target location by energy delivery catheter 100, as described herein. Energy pulse generator 310 can be configured to generate pulse 315, where any pulse can comprise optical energy that is delivered to the target location to generate one or more pressure waves PW and / or pressure gradients TPG within a target material proximate the target location. For example, energy pulse generator 310 can comprise a light source, such as a laser light source. Pulse 315 can comprise a pulse of laser light, such as a pulse of laser light that is configured to generate one or more bubbles BV within the target location. In contrast to systems that use electrical signals to generate pressure waves (such as an RF generator) which can deliver only a limited number of pulses per second (e.g., 2 pulses per second), an optical emitter can generate and deliver short pulses of light at much higher repetition rates (e.g., 100Hz).

[0119]

[0113] Energy pulse 315 can be configured to generate pressure wave PW, such as by causing the formation of rapidly expanding and / or collapsing bubbles BV within a target location (e.g., one or more pulses 315 can each generate one or more bubbles BV, that each create one or more pressure waves PW), as described herein. In some embodiments, one or more bubbles BV Attorney Docket No. GYT-027-PCT created by system 10 comprise non-spherical-shaped bubbles, non-symmetric-shaped bubbles, or both. Alternatively, or additionally, one or more bubbles BV created by system 10 comprise spherical and / or near-spherical bubbles. In some embodiments, a pressure wave PW comprises two pressure waves that are generated by at least a first bubble BV1, such as a first pressure wave PW 1 and a second pressure wave PW2. Pressure wave PW 1 can be the result of the rapid expansion of bubble BV1, and pressure wave PW2 can be the result of the rapid collapse of bubble BV1. In some embodiments, pressure wave PW1 comprises a different energy level than pressure wave PW2, such as when pressure wave PW1 comprises a greater energy level than pressure wave PW2. Alternatively, pressure wave PW2 can comprise a greater energy level than pressure wave PW1. In some embodiments, pulse 315, compound 20, emitter assembly 115, and / or another component or parameter of system 10 is configured to maximize and / or minimize the pressure level of a pressure wave, such as pressure wave PW1, and / or to minimize and / or maximize (respectively) the pressure level of a pressure wave, such as pressure wave PW2. For example, system 10 can be configured to suppress and / or otherwise minimize pressure wave PW2 that can be caused by the rapid collapse of bubble BV1. In some embodiments, two or more pressure waves can constructively and / or destructively interact, for example to increase a pressure gradient TPG (e.g., to increase the resultant gradient caused by either of the two or more pressure waves independently) proximate a target material, and / or to decrease a pressure gradient TPG proximate a non-target material (e.g., proximate non-target tissue). In some embodiments, pressure wave PW is created by the rapid collapse of one or more bubbles BV, for example when bubble BV collapses in less than Ips. In some embodiments, bubble BV is generated over a generation time period GTP, and bubble BV collapses over a collapse time period CTP. In some embodiments, time period GTP is greater than time period CTP (e.g., bubble BV takes longer to be generated than to collapse).

[0120]

[0114] Energy distribution catheter 200 includes energy distributor 210 and can be configured to position compound 20 proximate a target material. Energy distribution catheter 200 can include an elongated body, shaft 220, including proximal portion 222 and distal portion 228, with one or more lumens extending therethrough, such as guide lumen 223 and / or fluid lumen 224, each shown. In some embodiments, energy distribution catheter 200 is configured to be delivered to a patient site (e.g., to position energy distributor 210 proximate a target material) in an over-the-wire arrangement, such as when guide lumen 223 is constructed and arranged to Attorney Docket No. GYT-027-PCT slidingly receive a catheter configured as a rail, for example when energy delivery catheter 100 is configured as a rail, such that one or more over-the-wire and / or rapid exchange devices of system 10 can be inserted over and / or use energy delivery catheter 100 as a rail. For example, guide lumen 223 of energy distribution catheter 200 can be configured to slidingly receive shaft 120 and / or energy delivery core 110 of energy delivery catheter 100 (e.g., proximal end 111 of energy delivery core 110 can be inserted into a distal end of guide lumen 223), such that energy distribution catheter 200 can be “delivered over” (e.g., transluminally advanced over) energy delivery catheter 100 (e.g., slidingly advanced and / or retracted over catheter 100, using catheter 100 as a “rail”, as described herein). Energy distribution catheter 200 can be delivered over energy delivery catheter 100 (e.g., by an operator of system 10) to position energy distributor 210 proximate emitter assembly 115, for example, such that emitter assembly 115 and energy distributor 210 are positioned proximate a target material to be treated by system 10.

[0121]

[0115] In some embodiments, energy distributor 210 is located on distal portion 228 of shaft 220. In some embodiments, guide lumen 223 of shaft 220 extends through energy distributor 210. Energy distributor 210 can comprise an inflatable balloon, such as an inflatable balloon configured to receive compound 20 (e.g., a fluid or other flowable material) from fill assembly 320 of console 300, as described herein. In some embodiments, shaft 220 is advanced into the patient (e.g., by an operator, using an over-the-wire method) with energy distributor 210 in an uninflated state, and energy distributor 210 is configured to be inflated (or otherwise expanded) when positioned proximate a target material. Fluid lumen 224 can fluidly connect energy distributor 210 to fill assembly 320 of console 300, for example via one or more connector assemblies, as described herein.

[0122]

[0116] In some embodiments, energy distribution catheter 200 can comprise a set of two or more catheters, such as two or more energy distribution catheters 200, each comprising different configurations. For example, a first energy delivery catheter 200a can comprise an energy distributor 210a comprising a first length LI and that is configured to inflate to a first diameter DI, and a second energy delivery catheter 200b can comprise a second energy distributor 210b comprising a second length L2 that is configured to inflate to a second diameter D2, where lengths LI and L2 comprise different lengths, and / or diameters DI and D2 comprise different diameters. Various energy distribution catheters 200 can comprise other configuration differences, such as differences in parameters selected from the group consisting of the length of Attorney Docket No. GYT-027-PCT shaft 220; the distance from the proximal end of shaft 220 to energy distributor 210; the material of shaft 220; the material of energy distributor 210; the configuration of energy distributor 210; and combinations of these. In some embodiments, the various configurations of energy distribution catheter 200 are each configured to work with one or more configurations of energy delivery catheter 100 (e.g., each energy distribution catheter 200 is configured to operate with at least a single “one-size-fits-all” configuration of energy delivery catheter 100).

[0123]

[0117] In some embodiments, emitter assembly 115 is configured to be positioned within energy distributor 210 (e.g., within a lumen that extends through energy distributor 210), such as when guide lumen 223 extends through energy distributor 210 (e.g., an inflatable balloon with a lumen therethrough). Energy distributor 210 can be filled with compound 20 (e.g., manually and / or automatically), such that emitter assembly 115, when positioned within energy distributor 210, can deliver pulse 315 to a target location within energy distributor 210 (e.g., a target location comprising a volume that is filled with compound 20, such as a volume that is positioned within energy distributor 210). Pulse 315 can be configured to generate bubbles BV within compound 20 and within energy distributor 210, where the rapid expansion and / or contraction of bubbles BV generate pressure waves PW. Pressure waves PW can propagate from the target location, through compound 20, through a portion of energy distributor 210, such as the wall of a balloon of energy distributor 210, and into a target material proximate energy distributor 210. The propagation of pressure waves PW through the target material can generate pressure gradients TPG within the target material that are configured to treat the target material, such as to cause calcifications (e.g., CAC) to fracture or otherwise disrupt or break down.

[0124]

[0118] In some embodiments, energy distributor 210 comprises a balloon, atherectomy element, and / or other treatment element that is configured to treat a target material (e.g., to provide an alternate and / or adjunctive treatment in addition to treatment provided by pressure gradients TPG described herein). For example, energy distributor 210 can comprise a balloon that is constructed and arranged as an angioplasty balloon (e.g., a balloon configured to apply a force to diseased tissue and / or other target material, such as to increase the flow pathway of an artery or other vessel). Alternatively, or additionally, energy distributor 210 can comprise a cutting balloon that is configured to remove diseased tissue and / or other target material (e.g., plaque or other diseased tissue) from an artery or other vessel. Alternatively, or additionally, energy distributor 210 can comprise a treatment element such as: a sharp blade, laser, rotating Attorney Docket No. GYT-027-PCT device, and / or other atherectomy element that is configured to remove diseased tissue and / or other target material.

[0125]

[0119] In some embodiments, compound 20 comprises a mixture of one or more materials (e.g., one or more fluids, fluidic compounds including suspended solid materials, and / or any flowable material), such as one or more flowable materials selected from the group consisting of: a dye, such as indocyanine green dye (ICG); a contrast material, such as a radiopaque contrast; saline; and combinations of these. In some embodiments, compound 20 comprises one or more materials that comprise properties related to the reaction of compound 20 to pulse 315 (e.g., properties which maximize and / or otherwise optimize the formation of bubble BV). The materials of compound 20 can be selected based on these properties and / or based on one or more properties of pulse 315. For example, a material of compound 20 can be selected based on the wavelength of pulse 315, for example a material with a high absorption of light at the wavelength of pulse 315. In some embodiments, compound 20 comprises two or more materials that interact with each other, for example two or more materials that interact over time. For example, compound 20 can comprise two or more materials that, once combined, interact in a manner that limits the “shelf life” of compound 20. Alternatively or additionally, compound 20 can comprise two or more materials that interact in the presence of one or more forms of light, electromagnetic energy, and / or other energy (e.g., as delivered by energy delivery catheter 100). Fill assembly 320 can be configured to deliver two or more materials of compound 20 separately to energy distributor 210, for example when fill assembly 320 comprises two or more syringes and / or two or more reservoirs of material, each configured to hold and deliver a separate material of compound 20. Separate materials of compound 20 that are delivered independently to energy distributor 210 can mix within energy distributor 210, such as to provide a homogeneous volume of compound 20 within energy distributor 210.

[0126]

[0120] One or more catheter devices of system 10, such as energy delivery catheter 100 and / or energy distribution catheter 200, can each include one or more markers, such as marker 198 and / or marker 298, respectively, each shown. Markers 198, 298 can include radiopaque, light-reflective, ultrasonically-reflective, and / or other markers that are configured to be visually identifiable by an imaging device of system 10, for example a fluoroscopic imaging device. In some embodiments, two or more markers 198, 298 are located proximate emitter assembly 115 Attorney Docket No. GYT-027-PCT and / or energy distributor 210, such as to indicate an emission region of energy delivery catheter 100 (e.g., a region between two markers where emitter assembly 115 can direct pulse 315).

[0127]

[0121] One or more catheters of system 10, such as energy delivery catheter 100 and / or energy distribution catheter 200, can comprise an assembly for providing one or more connections to console 300 or other devices of system 10. For example, energy delivery catheter 100 can comprise connector assembly 150, energy distribution catheter 200 can comprise connector assembly 250, and / or console 300 can comprise connector assembly 350. Connector assembly 150 can be configured to removably attach energy delivery catheter 100 to console 300 via connector assembly 350. Connector assemblies 150 and 350 can be configured to make an optical connection between energy delivery core 110 and energy pulse generator 310 (e.g., when energy pulse generator 310 comprises a light source that is configured to provide pulse 315 comprising a laser or other optical pulse). In some embodiments, connector assemblies 150 and / or 350 are configured to prepare a mating portion of energy delivery catheter 100 and / or console 300 prior to and / or during a connection step. For example, connector assemblies 150 and / or 350 can be configured as a self-cleaning connector assembly, such as when configured to clean an optical surface, such as the proximal end of energy delivery core 110 (e.g., energy delivery core 110 comprising an optical fiber), and / or a mating portion of an optical connector of connector assembly 350, such as to remove dust and / or other contaminants from affecting the delivery of pulse 315 from console 300 to energy delivery core 110. Connector assemblies 150 and / or 350 can comprise a mechanical cleaning element, such as a mechanical wiper configured to wipe contaminants from a mating surface of a connector assembly. Alternatively, or additionally, connector assemblies 150 and / or 350 can be configured to direct a jet of gas (e.g., air) towards one or more mating surfaces, where the jet of air is configured to remove contaminants. In some embodiments, connectors assemblies 150 and / or 350 are constructed and arranged to generate a jet of air while the assemblies are connected, such as a jet of air that is generated as two components are brought together, slidingly receive each other, and / or are otherwise moved relative to each other, where the movement of the two elements (e.g., the motion of the connection) can be configured to generate a jet of air.

[0128]

[0122] In some embodiments, a catheter of system 10, such as energy delivery catheter 100 and / or energy distribution catheter 200, can comprise an identifier configured to indicate one or more parameters (e.g., type, configuration, serial number, etc.) of the catheter to another Attorney Docket No. GYT-027-PCT component of system 10, such as console 300. For example, connector assembly 150 and / or connector assembly 250 can include ID element 159 and / or ID element 259, respectively. Console 300 can comprise a sensor that is configured to receive information from ID element 159 and / or ID element 259, such as ID sensor 359 of connector assembly 350 shown. ID sensor 359 can be configured to provide a signal to processing unit 305 of console 300 when a catheter or other device is operably connected to console 300 (e.g., energy delivery catheter 100 attached via connector assembly 350). In some embodiments, ID element 159 and / or ID element 259 comprise an RFID element, and ID sensor 359 can comprise an RFID reader. In some embodiments, console 300 is configured to record data, via ID sensor 359 from an ID element (e.g., ID element 159 comprising an RFID of an attached energy delivery catheter 100). For example, console 300 can record data selected from the group consisting of the number of clinical uses of a catheter; the number of connections and / or disconnections between a catheter and console 300; the number of pulses 315 delivered via energy delivery catheter 100; calibration information; and combinations of these.

[0129]

[0123] In some embodiments, ID sensor 359 is configured to detect the type (e.g., model or configuration) of energy delivery catheter 100 and / or energy distribution catheter 200 that is connected to console 300.

[0130]

[0124] In some embodiments, system 10 is configured to track the total energy (e.g., the total energy of each of pulse 315) that is delivered via an energy delivery catheter 100. In some embodiments, system 10 is configured to alert the operator to “overuse” of an energy delivery core 110, for example if the total energy delivered TED via energy delivery core 110 over a first time period TP1 is above a threshold. Additionally, or alternatively, overuse of an energy delivery core 110 can include the total energy TED via energy delivery core 110 over time (e.g., the lifecycle of the energy delivery core 110) that is above a threshold.

[0131]

[0125] In some embodiments, connector assembly 150 is removably attached to energy delivery catheter 100, and / or connector assembly 150 comprises two or more portions, where a first portion is fixedly attached to energy delivery catheter 100 and a second portion is removably attached. At least a portion of connector assembly 150 can be removably attached to energy delivery catheter 100, such that the largest outer diameter of any portion of energy delivery catheter 100 (e.g., with connector assembly 150 removed) is less than the inner diameter of guide lumen 223 of energy distribution catheter 200, for example, such that energy Attorney Docket No. GYT-027-PCT distribution catheter 200 can be delivered using an over-the-wire method where the proximal end of energy delivery catheter is inserted into the distal end of guide lumen 223, and shaft 220 is delivered over energy delivery catheter 100. Energy delivery core 110 can comprise a diameter of no more than 0.014”. In some embodiments the maximum outer diameter of any portion of energy delivery catheter 100 (e.g., with connector assembly 150 removed) comprises a diameter of no more than 0.014”.

[0132]

[0126] System 10 can be configured to treat a target material within the vasculature or other conduit of a patient, as described herein. In some embodiments, system 10 is configured to treat a target material while at least a portion of system 10 is positioned within a body lumen comprising a minimum diameter LMD. For example, at least distal portion 118 of energy delivery core 110, emitter assembly 115, at least distal portion 228 of shaft 220, and / or energy distributor 210 can be configured to be positioned within a lumen with a minimum diameter LMD (e.g., the OD of these portions of system 10 is no more than minimum diameter LMD). Minimum diameter LMD can comprise a diameter of no more than 0.044”, such as no more than 0.032”. In some embodiments, minimum diameter LMD comprises the inner diameter of a target vessel (e.g., an artery or other vessel comprising a target material to be treated) where a most-distal portion of energy delivery catheter 100 and / or energy distribution catheter 200 is to be positioned during a treatment procedure. Alternatively, or additionally, minimum diameter LMD can comprise the inner diameter of a narrowed portion (e.g., a diseased portion) of a vessel. For example, system 10 can be configured to cross a partially occluded portion of a vessel (e.g., to treat the occlusion), where minimum diameter LMD comprises the inner diameter of the occlusion (e.g., an inner diameter of the target vessel distal to the occlusion may comprise a diameter that is greater than minimum diameter LMD).

[0133]

[0127] System 10 can be configured to treat a segment of a target material comprising a length TTL, and / or to treat a partial and / or full circumferential segment of a target material, such as a target material that surrounds an inner portion of a vessel. Energy delivery catheter 100 can be configured to deliver a series of pulses 315 (sequentially, simultaneously, or both) to multiple target locations to treat a segment of a target material, “distributed target locations” herein, such as one or more locations distributed along length TTL and / or circumferentially distributed about the longitudinal axis of energy delivery core 110 (e.g., the longitudinal axis of the target vessel and / or the target material). In some embodiments, one or more emitter assemblies 115 are Attorney Docket No. GYT-027-PCT configured to deliver pulses 315 to two or more distributed target locations without modifying the location and / or orientation of energy delivery core 110 (e.g., without translating and / or rotating energy delivery core 110). Alternatively, or additionally, kinetic assembly 400 can be configured to axially translate and / or rotate energy delivery core 110 (e.g., including emitter assembly 115), such as to adjust the focal location of emitter assembly 115 to direct pulses 315 toward two or more distributed target locations.

[0134]

[0128] Kinetic assembly 400 can comprise one or more assemblies for rotating (e.g., manually and / or automatically rotating) at least a portion of a device of system 10, rotation module 410 shown. Additionally, or alternatively, kinetic assembly 400 can comprise one or more assemblies for at least retracting (e.g., manually and / or automatically retracting) at least a portion of a device of system 10, translation module 420 shown. In some embodiments, translation module 420 is further configured to advance at least a portion of a device of system 10. Kinetic assembly 400 can include one or more connecting devices that are configured to attach to and / or apply a force to one or more other devices of system 10, such as connector assembly 450 shown. Connector assembly 450 can be operably interconnected to rotation module 410 and / or translation module 420, such that connector assembly 450 can operably attach to a device of system 10 (e.g., attach to energy delivery core 110) and to transfer a force (e.g., a rotating force and / or a translating force) from rotation module 410 and / or translation module 420, respectively. In some embodiments, console 300 comprises at least a portion of kinetic assembly 400. Connector assembly 350 of console 300 can comprise at least a portion of connector assembly 450.

[0135]

[0129] As described herein, fdl assembly 320 can be configured to deliver fluid (e.g., compound 20) to control the inflation and / or pressure of a fluid within energy distributor 210

[0136] (e g., an energy distributor 210 comprising an inflatable balloon). Fill assembly 320 can include one or more fluid handling components, such as one or more pumps, syringes, syringe drive assemblies, reservoirs, and / or other components for providing a fluid to energy distributor 210. Fill assembly 320 can be configured to inflate and / or adjust the pressure of fluid within energy distributor 210 in a closed loop arrangement (e.g., via data processing provided by processing unit 305 of console 300). A functional element of system 10, for example functional element 299 of energy distribution catheter 200 and / or functional element 399 of console 300 (or both), can comprise a sensor configured to provide a signal related to the volume and / or pressure of Attorney Docket No. GYT-027-PCT fluid within energy distributor 210, such as a pressure sensor and / or a flow sensor (“fluid sensor” herein). Functional element 299 can comprise one or more fluid sensors that are positioned within and / or are proximate and fluidly attached to energy distributor 210 and / or a segment of fluid lumen 224. Alternatively, or additionally, functional element 399 can comprise one or more fluid sensors that are positioned within and / or are proximate and fluidly attached to fill assembly 320, a flow conduit of console 300, and / or connector assembly 350. Fill assembly 320 can be configured to deliver compound 20 to, and / or extract compound 20 from, energy distributor 210, in a closed loop arrangement, based on one or more signals from functional element 299 and / or functional element 399. Fill assembly 320 can be configured to maintain a steady pressure (e.g., a relatively constant pressure) of fluid within energy distributor 210, for example in a closed loop arrangement based on one or more signals from functional element 299 and / or functional element 399. In some embodiments, energy distributor 210 is configured to be filled to a target pressure, such as a pressure of no more than 4atm.

[0137]

[0130] In some embodiments, fill assembly 320 is configured to detect pressure changes within energy distributor 210 (e.g., based on one or more sensor signals). System 10 can be configured to analyze treatment data (e.g., data related to an ongoing treatment procedure comprising the delivery of one or more pulses 315) and pressure data from one or more sensors related to the pressure within energy distributor 210, such as to identify and / or predict changes in the compliance of a vessel within which energy distributor 210 is inflated (e.g., inflated within a vessel lumen in which a target material is located). Changes in the vessel compliance can be correlated by system 10 to treatment efficacy, for example when changes in vessel compliance are observed due to calcium fracture (e.g., when system 10 is used to treat CAC or other arterial calcifications). In these embodiments, one or more parameters of a treatment procedure can be adjusted (e.g., manually by a clinician and / or automatically by system 10), based on a measurement of vessel compliance performed by system 10, such as to optimize efficacy, safety, and other outcomes of the treatment procedure performed by system 10.

[0138]

[0131] In some embodiments, console 300 is configured to determine the size and / or shape of energy distributor 210 via one or more images, such as one or more OCT images. Image data can be analyzed by system 10 to determine pressure changes, size changes, and / or other identifiable changes of energy distributor 210 that can be correlated by system 10 to the efficacy of a treatment. In some embodiments, energy delivery catheter 100 (as well as console 300) is Attorney Docket No. GYT-027-PCT constructed and arranged to perform OCT imaging. In these embodiments, one or more parameters of a treatment procedure can be adjusted (e.g., manually by a clinician and / or automatically by system 10), based on these images collected by system 10, such as to optimize efficacy, safety, and other outcomes of the treatment procedure performed by system 10.

[0139]

[0132] In some embodiments, console 300 is configured to deliver an imaging agent to the patient, such as an agent configured to enable and / or enhance imaging, for example a contrast agent. A contrast agent can be delivered by a functional element 299 comprising an imaging agent delivery assembly, such as delivery via guide lumen 223 and / or another lumen of shaft 220 or energy delivery catheter 100. Alternatively, or additionally, in some embodiments, system 10 is configured to be used (e.g., used to treat tissue as described herein) without the injection of contrast agent. For example, energy distributor 210 can comprise marker 298, such as when energy distributor 210 comprises a radiopaque coating. Energy distributor 210 comprising a radiopaque coating can be visualized (e.g., using fluoroscopic imaging) and prevent and / or limit the need for injection of a contrast agent. In some embodiments, energy distributor 210 comprises a balloon configuration, as described herein. In some embodiments, energy distributor 210 comprises a polymer balloon that is doped with a radiopaque material.

[0140]

[0133] Referring now to Fig. 2, a flow chart of a method of treating a target material by providing a therapeutic pressure gradient within the target material is illustrated, consistent with the present inventive concepts. Method 1000 of Fig. 2 can be performed using system 10 described herein in reference to Fig. 1, Fig. 1A, and otherwise herein. Method 1000 can comprise a method of performing lithotripsy, such as intravascular lithotripsy (IVL) using laserbased energy, to treat a target material (e.g., laser-based IVL performed using system 10, as described herein).

[0141]

[0134] In Step 1100, a first catheter is delivered though a body lumen, such as to position an energy emitter proximate a target material. For example, energy delivery catheter 100 can be intravascularly translated (e.g., advanced and / or retracted) through the vasculature of the patient to position emitter assembly 115 proximate a target material, such as a target material comprising CAC.

[0142]

[0135] In an optional Step 1200, a second catheter can be delivered through a body lumen, such as to position an energy distributor proximate the target material. For example, energy distribution catheter 200 can be delivered such as to position energy distributor 210 proximate Attorney Docket No. GYT-027-PCT emitter assembly 115. In some embodiments, distribution catheter 200 is delivered in an over- the-wire arrangement, where energy distribution catheter 200 is delivered over (e.g., slidingly translated over) energy delivery catheter 100, as described herein.

[0143]

[0136] In another optional Step 1250, energy distributor 210 can be expanded proximate a target material. For example, energy distributor 210 can comprise a balloon that is configured to receive a fluid, such as compound 20, from console 300, as described herein. Energy distributor 210 can be expanded to contact a target material and / or tissue or other material proximate the target material.

[0144]

[0137] In Step 1300, a pulse of energy is created, such as a pulse 315 that is created by energy pulse generator 310, as described herein. Energy pulse 315 can be coupled to energy delivery catheter 100, such as coupled into energy delivery core 110 to be delivered to a target location via energy delivery catheter 100.

[0145]

[0138] In Step 1400, energy pulse 315 is delivered to a target location proximate a target material. In some embodiments, the target location is located within energy distributor 210, such as when the target location comprises a volume of compound 20 (e.g., a pre-determined volume of compound 20). Energy pulse 315 can be configured to generate one or more pressure waves PW, such as one or more pressure waves PW that are generated by the rapid expansion and / or rapid collapse of one or more bubbles BV that are formed in response to the delivery of pulse

[0146] 315 to the target location, as described herein. As described herein, system 10 can be configured to suppress and / or otherwise minimize a pressure wave PW2 that can be caused by the rapid collapse of bubble BV1. Method 1000 can comprise minimization of pressure wave PW2, such as with the induction of a subsequent pressure wave PW that is configured to destructively interfere with pressure wave PW2.

[0147]

[0139] In Step 1500, pressure wave PW is coupled into the target material, for example as pressure wave PW propagates from the target location, the wave continues through the medium surrounding the target location (e.g., compound 20) and continues through the target material. The propagation of pressure wave PW through the target material causes one or more therapeutic pressure gradients within the target material, such as pressure gradient TPG described herein. In some embodiments, energy distributor 210 is constructed and arranged to allow the propagation of pressure waves PW through compound 20, through a portion of energy distributor 210, such as a wall of a balloon of energy distributor 210, and into the target material. In some Attorney Docket No. GYT-027-PCT embodiments, energy distributor 210 is expanded, such as in Step 1250, to contact a target material and provide an interface between energy distributor 210 and the tissue, where the interface is configured to minimize pressure loss of pressure wave PW as the wave is coupled to the tissue.

[0148]

[0140] In optional Step 1600, emitter assembly 115 is repositioned, such that a “next” energy pulse 315 can be delivered to a “next” target location, such as to provide a pressure gradient TPG to a “next” target material. In some embodiments, energy distributor 210 can also be repositioned in Step 1600. Energy distributor 210 can be contracted prior to repositioning and expanded when properly positioned in a “next” position.

[0149]

[0141] In some embodiments, Steps 1300 through 1600 can happen in a single process, for example when energy delivery catheter 100 is translated (e.g., retracted) and or rotated (e.g., by kinetic assembly 400) as multiple pulses 315 are delivered to a sequence of target locations, such as to treat multiple portions of a target material and / or to treat multiple target materials. In some embodiments, emitter assembly 115 is retracted and / or rotated within energy distributor 210 (e.g., such that energy distributor 210 does not require retraction).

[0150]

[0142] In optional Step 1700, system 10 can be configured to remove one or more residual “microbubbles”, such as one or more microbubbles that have been generated within compound 20 from the formation and collapse of bubbles BV. In some embodiments, fill assembly 320 is configured to circulate and / or otherwise remove and replace compound 20 from energy distributor 210, such as to remove any existing microbubbles from energy distributor 210. In some embodiments, Step 1700 is performed between each delivery of an energy pulse 315.

[0151]

[0143] Referring now to Fig. 3, a schematic view of a distal portion of an embodiment of an energy delivery catheter is illustrated, consistent with the present inventive concepts. Energy delivery catheter 100 and / or other components of system 10 described in Fig. 3 can be of similar construction and arrangement as the similar components described in reference to Fig. 1, Fig.

[0152] 1A, and otherwise herein. A distal segment of energy delivery catheter 100 is shown, including energy delivery core 110 surrounded by shaft 120. Energy delivery core 110 can comprise an optical conduit, such as one or more optical fibers, as described herein. Energy delivery core 110 can include one or more layers, such as a fiber core, fiber 1101, surrounded by one or more cladding layers, cladding 1102, each shown. Shaft 120 can surround energy delivery core 110, as shown. Attorney Docket No. GYT-027-PCT

[0153]

[0144] Emitter assembly 115 can include one or more optical elements that are constructed and arranged to direct pulse 315 from fiber 1101 toward a location (e.g. a target location that is proximate a target material, as described herein). For example, emitter assembly 115 can include an optical element comprising one or more reliefs, such as wedge 1151 shown, that are manufactured into fiber 1101 (e.g., manufactured via one or more relief cuts or as otherwise described herein). For example, wedge 1151 can comprise a relief that is machined into fiber 1101 (in a manufacturing process), such as via a laser machining process. Laser machining can comprise pulsed laser machining, such as ultrashort pulsed-laser machining.

[0154]

[0145] Wedge 1151 can include angle a and depth DW, as shown. Angle a and / or depth DW can be arranged to control the deflection of pulse 315 from fiber 1101 towards the target location.

[0155]

[0146] In some embodiments, wedge 1151 includes one or more surface modifications and / or coatings, coating 1152 shown. Coating 1152 can comprise a metal coating, and / or other coating that is configured to reflect pulse 315. In some embodiments, wedge 1151 can be oriented proximally (as shown) such that pulse 315 is reflected through fiber 1101 and exits a wall of fiber 1101 opposite wedge 1151. In this arrangement, wedge 1151 can be arranged for total internal reflection of pulse 315, for example when wedge 1151 does not comprise a reflective coating 1152 (e.g., wedge 1151 comprises an air interface that causes total internal reflection of pulse 315). Alternatively, wedge 1151 can be oriented distally (opposite of shown) such that pulse 315 exits a face (e.g., a machined face) of fiber 1101 and reflects off the surface of wedge 1151 to be directed toward a target location. In this arrangement, coating 1152 can comprise a reflective coating.

[0156]

[0147] In some embodiments, shaft 120 includes one or more segments that each include openings where energy delivery core 110 is exposed, window 121 shown. Window 121 can comprise a relief that is manufactured into shaft 120, such as a relief that is machined in a manufacturing process (e.g., a laser machining manufacturing process). Alternatively, or additionally, window 121 can comprise a spacing between two portions of shaft 120, for example two portions of tubing or other covering of energy delivery core 110 that are assembled such that window 121 is created. Window 121 can comprise a circumferential opening or can comprise a partial circumferential opening in shaft 120. In some embodiments, during a manufacturing process, wedge 1151 is machined through window 121, for example when shaft 120 is first Attorney Docket No. GYT-027-PCT positioned surrounding energy delivery core 110, and wedge 1151 is subsequently machined within window 121. In this arrangement, the longitudinal alignment of window 121 can be controlled via the manufacturing of wedge 1151 instead of via longitudinal alignment of shaft 120 to energy delivery core 110 during the manufacturing process.

[0157]

[0148] In some embodiments, emitter assembly 115 includes one or more focusing elements, lens 1153 shown. Lens 1153 can be constructed and arranged to focus pulse 315 to a target location, for example a pulse 315 that has been deflected by wedge 1151 to exit a side portion of fiber 1101, as shown. Alternatively, or additionally, wedge 1151 can comprise a shape (e.g., a concave and / or a convex shape, based on the orientation of wedge 1151) that is arranged to both reflect and focus pulse 315. In some embodiments, the lens 1153 is formed by an additive manufacturing process (e.g., 3D printing).

[0158]

[0149] Referring now to Fig. 4, a schematic view of a distal portion of an embodiment of an energy delivery catheter is illustrated, consistent with the present inventive concepts. Energy delivery catheter 100 and / or other components of system 10 described in Fig. 4 can be of similar construction and arrangement as the similar components described in reference to Fig. 1, Fig.

[0159] 1A, and otherwise herein. A distal segment of energy delivery catheter 100 is shown, including energy delivery core 110 surrounded by shaft 120. Energy delivery core 110 can include fiber 1101 surrounded by cladding 1102, as shown. Energy delivery catheter 100 can include shaft 120 surrounding energy delivery core 110, as shown.

[0160]

[0150] In some embodiments, emitter assembly 115 comprises a tapered portion of energy delivery core 110, such as a tapered distal portion of fiber 1101, taper 1154 shown. Taper 1154 comprises a length TL as shown. In some embodiments, length TL of taper 1154 comprises a length such that taper 1154 comprises a narrow taper that is configured to create a “point emission” of pulse 315 from taper 1154. Alternatively, length TL of taper 1154 can comprise a length such that taper 1154 comprises a long taper configured for “distributed emission” of pulse 315 from taper 1154. In some embodiments, taper 1154 is constructed and arranged to focus pulse 315 into a ring of light, such as a ring of light that is configured to generate a ring-like bubble BV (e.g., a torus-shaped bubble). In some embodiments, emitter assembly 115 comprises two or more emitters each configured to focus portions of a pulse 315 to create two or more simultaneous rings of light, such as to generate two or more simultaneous torus-shaped bubbles BV. Attorney Docket No. GYT-027-PCT

[0161]

[0151] In some embodiments, at least a portion of fiber 1101, such as taper 1154, comprises a GRIN portion and / or a portion including a fiber Bragg grating configured to manipulate pulse 315 to direct and / or focus pulse 315 toward a target location, as described herein. In these embodiments, the GRIN portion and / or the fiber Bragg grating portion can be configured to: create a point emission of the energy pulse; create a ring of light (e.g. a ring of light configured to generate a ring-like bubble BV); and / or create multiple rings of light. In some embodiments, the GRIN portion is formed using an additive manufacturing (e.g., 3D printing) process.

[0162]

[0152] Referring now to Figs. 5 A and 5B, illustrative examples of light emission patterns from various embodiments of emitter assemblies are illustrated, consistent with the present inventive concepts. Energy delivery catheter 100 and / or other components of system 10 described in Figs. 5A and 5B can be of similar construction and arrangement as the similar components described in reference to Fig. 1, Fig. 1A, and otherwise herein. Fig. 5A shows an illustration of an embodiment of energy delivery core 110 including emitter assembly 115 with wedge 1151 for directing pulse 315 toward a target location, for example as described in reference to Fig. 3 and otherwise herein. A photograph of a light emission pattern based on this embodiment is also shown.

[0163]

[0153] Fig. 5B shows a photograph of a light emission pattern based on an embodiment of energy delivery core 110 including emitter assembly 115 with a taper 1154, for example as described in reference to Fig. 4 and otherwise herein.

[0164]

[0154] Referring now to Fig. 6, a photograph of an embodiment of an energy distribution catheter is illustrated, consistent with the present inventive concepts. Energy distribution catheter 200 and / or other components of system 10 described in Fig. 4 can be of similar construction and arrangement as the similar components described in reference to Fig. 1, Fig. 1A, and otherwise herein. Energy distribution catheter 200 comprises energy distributor 210. Energy distributor 210 can comprise an inflatable balloon, balloon 2101 shown. In some embodiments, balloon 2101 comprises a cutting balloon, such as a cutting balloon configured to provide non-energy-based treatment (e.g., via abrasion, cutting, and / or other physical tissue manipulation) to a target material.

[0165]

[0155] Balloon 2101 comprises length BL and diameter BD (e.g., a maximum inflated diameter of balloon 2101). Balloon 2101 can comprise a compliant or a non-compliant balloon. In some embodiments, diameter BD comprises a diameter of at least 2.5mm, such as at least Attorney Docket No. GYT-027-PCT

[0166] 3.56mm, 6.5mm, 8.0mm, or 10.0mm. Additionally, or alternatively, diameter BD can comprise a diameter of no more than 12.0mm, such as no more than 9.0mm, 7.0mm, 6.0mm, or 4.0mm. Length BL can comprise a length of at least 12mm and / or a length of no more than 60mm, such as no more than 40mm or 30mm.

[0167]

[0156] Referring now to Figs. 7, 7A and 7B, a perspective view of the distal portion of an embodiment of an energy distribution catheter with an energy delivery catheter slidingly positioned therein, and magnified views of the proximal and distal ends of the energy distributor of the energy distribution catheter are illustrated, respectively, consistent with the present inventive concepts. Energy distribution catheter 200 and / or other components of system 10 described in reference to Figs. 7, 7A, and 7B can be of similar construction and arrangement as the similar components described in reference to Fig. 1, Fig. 1A, and otherwise herein. Fig. 7 shows a perspective view of the distal portion of an embodiment of energy distribution catheter 200 including energy distributor 210. Energy delivery catheter 100 can include energy delivery core 110, that can be slidingly received within shaft 220 of energy distribution catheter 200. Energy delivery core 110 can include one or more emitter assemblies, such as a proximal emitter assembly, emitter assembly 115a and a distal emitter assembly, emitter assembly 115b, each shown. Emitter assemblies 115 can be positioned within energy distributor 210, such as energy distributor 210 comprising balloon 2101 shown.

[0168]

[0157] In some embodiments, shaft 220 includes shaft distal portion 228, such as an offset distal portion comprising guide lumen 223 therethrough, as shown. Shaft 120 of energy delivery catheter 100 can include one or more shafts, such as spine 1106 shown. In some embodiments, energy delivery core 110 can include one or more sets of one or more optical fibers 1101, such as fiber bundle 1105a and fiber bundle 1105b, each shown. Each fiber bundle 1105 can include one or more optical fibers 1101. Each fiber bundle 1105 can terminate at an emitter assembly 115, such as fibers 1101 of fiber bundle 1105a terminating at emitter assembly 115a positioned in the proximal portion of energy distributor 210, and fibers 1101 of fiber bundle 1105b terminating at emitter assembly 115b positioned in the distal portion of energy distributor 210, as shown. In some embodiments, energy delivery catheter 100 includes one or more markers, such as marker 198a positioned proximate emitter assembly 115a and / or marker 198b positioned proximate emitter assembly 115b, as shown. Shaft 120 can comprise one or more elongate shafts, such as spine 1106 shown, and / or fibers 1101 (e g., fibers 1101 form shaft 120, without other structural Attorney Docket No. GYT-027-PCT elements). In some embodiments, fibers 1101 of fiber bundles 1105a and / or 1105b are oriented about spine 1106, as shown. In some embodiments, markers 198a and / or 198b provide a securing force that binds fibers 1101 to spine 1106.

[0169]

[0158] Fig. 7A shows the proximal portion of energy distributor 210 of Fig. 7. Fig. 7B shows the distal portion of energy distributor 210 of Fig. 7. As shown in Fig. 7A, fibers 1101 of fiber bundle 1105a can terminate at emitter assembly 115a near the proximal end of balloon 2101. One or more pulses or sets of pulses (e.g., pulses 315 described herein) can be delivered via fibers 1101 of fiber bundle 1105a to a location within balloon 2101 proximate emitter assembly 115a. Similarly, one or more pulses or sets of pulses can be delivered via fibers 1101 of fiber bundle 1105b to a location within balloon 2101 proximate emitter assembly 115b.

[0170]

[0159] As shown in Fig. 7B, the distal end of spine 1106 can be positioned within shaft 220 (e g., within a lumen of shaft 220 distal to energy distributor 210). Shaft 220 can receive the distal portion of spine 1106 to align energy delivery core 110 with the central axis of balloon 2101. In some embodiments, spine 1106 comprises a centerless ground spring wire, a tube, and / or a coil construction. In some embodiments, the distal end of spine 1106 comprises a tapered geometry, for example as shown in Fig. 7. Each fiber 1101 can comprise an element configured to emit a light pulse from the fiber toward a focus location, for example reflector 1155. For each fiber bundle 1105, each fiber 1101 can comprise reflector 1155. In some embodiments, reflectors 1155 of a fiber bundle can be aligned axially, such that pulses emitted from each fiber 1101 are focused to locations in a plane. Pulses can be delivered through fibers 1101 in sequence and / or simultaneously from two or more fibers 1101. In some embodiments, pulses are delivered from one or more fibers 1101 of a first fiber bundle 1105 (e.g., fiber bundle 1105a) in sequence and / or simultaneously with two or more fibers 1101 of a second fiber bundle (e.g., fiber bundle 1105b). In some embodiments fibers 1101 are secured to spine 1106, such that spine 1106 and fibers 1101 provide support to each other (e.g., column strength), such as to enhance the deliverability of energy delivery catheter 100 and / or energy distribution catheter 200.

[0171]

[0160] Referring now to Figs. 8A and 8B, a perspective view of the distal end of an embodiment of an integrated energy delivery catheter and energy distribution catheter, and a perspective of the distal portion of the shaft of the catheter are illustrated, respectively, consistent with the present inventive concepts. Catheters 100 and 200 and / or other components of system Attorney Docket No. GYT-027-PCT

[0172] 10 described in reference to Figs. 8A and 8B can be of similar construction and arrangement as the similar components described in reference to Fig. 1, Fig. 1A, and otherwise herein. Fig. 8A shows the distal end of a combination energy delivery catheter and energy distribution catheter, catheter 100 / 200. In some embodiments, energy delivery catheter 100 and energy distribution catheter 200 comprise a single device, catheter 100 / 200, for example where shaft 120 and / or energy delivery core 110 of energy delivery catheter 100 are not removable from shaft 220 of energy distribution catheter 200. In some embodiments, shaft 120 extends the length of catheter 100 / 200, extending to the distal end of shaft 220, as shown in Fig. 8A. Guide lumen 223 can extend through shafts 120 and 220, and / or alongside of shaft 120 within shaft 220 (e.g., when shaft 220 comprises a multi-lumen shaft). In some embodiments, at least a portion of the length of shafts 120 and 220 comprise a single shaft, such as a single shaft comprising a single lumen therethrough. In some embodiments, shafts 120 and 220 comprise a single shaft comprising two portions (e.g., two shaft portions) that are fused in a manufacturing process, such as fused using a reflowing process.

[0173]

[0161] Energy distributor 210 can comprise balloon 2101. Energy delivery core 110 can include one or more emitter assemblies, such as emitter assembly 115a and emitter assembly 115b, shown. Energy delivery core 110 can include one or more sets of fibers 1101, such as fiber bundle 1105a and fiber bundle 1105b shown. In some embodiments, shaft 120 includes spine 1106. Spine 1106 can comprise one or more projections along its length, such that one or more fibers 1101 can be arranged along spine 1106, where the projections separate and maintain the orientation of fibers 1101 about spine 1106. In some embodiments, emitter assemblies 115a and / or 115b can comprise a planar array of reflectors 1155, such as described in reference to Fig. 7 and otherwise herein.

[0174]

[0162] In some embodiments, spine 1106 extends distally from energy distributor 210 and terminates within a distal portion of shaft 220, for example approximately 5cm from the proximal end of energy distributor 210. Proximal to spine 1106, fibers 1101 can be arranged into one or more bundles, extending through one or more lumens of shaft 220 and / or shaft 120, as shown in Fig. 8B. The proximal portion of shaft 120 and / or shaft 220 can comprise a multilumen extrusion, such as lumens including guide lumen 223, fluid lumen 224, and / or one or more lumens through which fibers 1101 of energy delivery core 110 extend. Attorney Docket No. GYT-027-PCT

[0175]

[0163] Referring now to Figs. 9A through 9D, perspective views of the distal end of an embodiment of an energy delivery catheter and an energy distribution catheter, the handle of the energy delivery catheter, and the proximal and distal ends of the energy distributor of the energy distribution catheter are illustrated, respectively, consistent with the present inventive concepts. Catheters 100 and 200 and / or other components of system 10 described in reference to Figs. 9A through 9D can be of similar construction and arrangement as the similar components described in reference to Fig. 1, Fig. 1 A, and otherwise herein. Shaft 120 of energy delivery catheter 100 can be slidingly received within shaft 220 of energy distribution catheter 200. Alternatively, at least a portion of energy delivery catheter 100 can be fixedly positioned within energy distribution catheter 200 (e.g., when energy delivery catheter 100 and energy distribution catheter 200 comprise a combination device, as described herein). Shaft 120 can comprise one or more lumens, such as lumen 125 shown. Energy delivery core 110 can be slidingly positioned within lumen 125, for example such that energy delivery core 110 can be selectively positioned within the distal portion of lumen 125 within energy distributor 210. In some embodiments, energy distributor 210 comprises balloon 2101, as shown. Energy delivery catheter 100 can include a handle positioned on the distal end of shaft 120, handle 130 shown. Handle 130 can include one or more user controls, control 131, also shown. Control 131 can be operably attached to energy delivery core 110, such that actuation (e.g., proximal and distal sliding) of control 131 translates emitter assembly 115 within lumen 125 (e.g., proximally and distally translates within balloon 2101, respectively). Alternatively, or additionally, handle 130 can comprise a motorized assembly configured to translate energy delivery core 110. In some embodiments, handle 130 can be configured to continuously and / or semi-continuously reciprocate emitter assembly 115 within balloon 2101. In some embodiments, emitter assembly 115 can be translated proximally such as to be positioned proximal to balloon 2101. In some embodiments, a portion of shaft 220 is configured to prevent pulses (e.g., pulses 315) from exiting shaft 220 (e.g., when emitter assembly 115 is positioned within this portion of shaft 220). For example, a portion of shaft 220 can comprise a wavelength matched polymer, a metal sleeve, and / or another construction configured to prevent the transmission of pulses 315 through the shaft.

[0176]

[0164] Fig. 9C shows an embodiment of energy delivery core 110. Energy delivery core 110 of Fig. 9C can include fiber bundle 1105 of fibers 1101. Each fiber 1101 can include a reflector Attorney Docket No. GYT-027-PCT

[0177] 1155, as described herein. Fig. 9D shows another embodiment of energy delivery core 110, with energy delivery core 110 comprising a single fiber 1101 including reflector 1155. Emitter assembly 115 of Fig. 9C is shown positioned in the proximal portion of balloon 2101. Emitter assembly 115 of Fig. 9D is shown positioned in the distal portion of balloon 2101. In some embodiments, lumen 125 is configured to frictionally engage energy delivery core 110, such as to prevent unwanted translation of energy delivery core 110 within lumen 125.

[0178]

[0165] Shaft 120 can include distal portion 128 shown. Distal portion 128 can comprise construction that differs from one or more other portions (e.g., proximal portions) of shaft 120. For example, distal portion 128 can comprise a spring coil and / or other reinforcement. Distal portion 128 can comprise a spring coil construction, a braided construction, and / or a monofilament polymer construction. The construction of distal portion 128 can be configured to enhance the deliverability of energy delivery catheter 100 and / or energy distribution catheter 200. In some embodiments, distal portion 128 comprises a different stiffness than other portions of shaft 120. In some embodiments, distal portion 128 is positioned within a lumen of distal portion 228 of shaft 220, for example as shown in Fig. 9D.

[0179]

[0166] In some embodiments, energy delivery core 110 is fixedly attached to control 131, such that translation of control 131 causes the translation of energy delivery core 110, as described here above. In some embodiments, translation of energy delivery core 110 and control 131 are linked in a one-to-one configuration. In some embodiments, when energy distributor 210 is in a radially compact geometry, slack can exist between control 131 and emitter assembly 115 (e.g., a slack portion of energy delivery core 110 can be positioned in handle 130). In some embodiments, the slack of energy delivery core 110 can match the elongation of energy distributor 220 caused by transition to a radially expanded geometry (e.g., balloon dilation length).

[0180]

[0167] Referring now to Figs. 10A and 10B, side and perspective views of an embodiment of a fiber cap portion of an emitter assembly are illustrated, respectively, consistent with the present inventive concepts. Emitter assembly 115 and / or other components of system 10 described in reference to Figs. 10A and 10B can be of similar construction and arrangement as the similar components described in reference to Fig. 1, Fig. 1A, and otherwise herein. In some embodiments, emitter assembly 115 can include an assembly for focusing pulse 315 and / or focusing or concentrating a pressure wave PW, for example fiber cap 116 shown. Fiber cap 116 Attorney Docket No. GYT-027-PCT can be configured to be positioned on the distal end of a fiber 1101 (not shown) of energy delivery core 110. Fiber cap 116 can include body 1161, including a proximal relief, port 1162, that slidingly receives the distal end of a fiber 1101. Port 1162 can include distal face 1163, that can be configured to align with the distal face of fiber 1101 (e.g., to mate with and optically couple to fiber 1101). Distal face 1163 and / or the geometry of the distal end of fiber 1101 can be configured to focus and / or otherwise direct pulse 315 to a target location (e.g., a target location within an energy distributor, such as a balloon 2101, described herein).

[0181]

[0168] Fiber cap 116 can be constructed and arranged to reflect at least a portion of a pressure wave PW, for example pressure wave PW caused by the creation and / or collapse of bubble BV that is created by the delivery of pulse 315 to a target location. For example, fiber cap 116 can comprise a surface for reflecting the pressure wave, reflector 1165. Reflector 1165 can comprise a shape that is configured to reflect and / or focus a portion of pressure wave PW originally travelling away from target material toward the target material (e.g., to increase the pressure gradient TPG generated within the target material as a result of the creation and / or collapse of bubble BV).

[0182]

[0169] In some embodiments, fiber cap 116 is configured to prevent pulse 315 from exiting emitter assembly 115 in unwanted directions, such as distally from fiber cap 116. Fiber cap 116 can include dispersion element 1168 that can be configured to absorb and / or disperse any energy from pulse 315 that reaches the distal end of fiber cap 116.

[0183]

[0170] Referring now to Figs. 11, 11 A and 1 IB, a perspective view of an embodiment of an integrated energy delivery catheter and energy distribution catheter, a perspective view of the distal portion of the energy distributor of the catheter, and a perspective view of a portion of the energy delivery core including an emitter assembly are illustrated, respectively, consistent with the present inventive concepts. Catheters 100 and 200 and / or other components of system 10 described in reference to Fig. 11 and Figs. 11 A and 1 IB can be of similar construction and arrangement as the similar components described in reference to Fig. 1, Fig. 1A, and otherwise herein. Fig. 11 shows a combination energy delivery catheter and energy distribution catheter, catheter 100 / 200. In some embodiments, energy delivery catheter 100 and energy distribution catheter 200 comprise a single device, catheter 100 / 200, for example as described in reference to Fig. 8A and otherwise herein. Integrated catheter 100 / 200 can include shaft 120 and shaft 220, with energy distributor 210 positioned on a distal portion of shaft 220, and the distal portion of Attorney Docket No. GYT-027-PCT energy delivery core 1 10 positioned within energy distributor 210. In some embodiments, energy distributor 210 comprises balloon 2101.

[0184]

[0171] As shown in Fig. 11A, shaft 120 can include lumen 125. Energy delivery core 110 can be positioned within lumen 125. Emitter assembly 115 can be positioned within a portion of lumen 125 that is within energy distributor 210, as shown. Energy delivery core 110 can include one or more fibers 1101, each including a reflector 1155, as described herein. In some embodiments, distal portion 128 of shaft 120 extends beyond distal portion 228 of shaft 220, as shown. As shown in Fig. 1 IB, lumen 125 can comprise a geometric profile configured to orient fibers 1101 along the length of shaft 120. One or more energy pulses (e.g., pulses 315 described herein) can be delivered to a target location through the wall of shaft 120 and / or shaft 220. Alternatively, or additionally, shaft 120 and / or shaft 220 can comprise a window, such as window 121 described in reference to Fig. 3 and otherwise herein.

[0185]

[0172] In some embodiments, energy delivery core 110 comprises multiple fibers 1101, such as four fibers 1101 shown. Fibers 1101 can comprise multimode fibers, such as 105p multimode fibers. Reflectors 1155 can comprise polished metalized emitters, such as emitters polished with a 60° angle. In some embodiments, energy delivery core 110 comprises a single fiber 1101, such as a fiber 1101 comprising a diameter of at approximately 80p. Reflector 1155 can comprise a conical tapered polish (e.g., when energy delivery core 110 comprises a single fiber 1101).

[0186]

[0173] Referring now to Fig. 12, a schematic view of an embodiment of a console including multiple pulse generators and the proximal portion of an energy delivery catheter is illustrated, consistent with the present inventive concepts. Console 300, energy delivery catheter 100, and / or other components of system 10 described in reference to Fig. 12 can be of similar construction and arrangement as the similar components described in reference to Fig. 1, Fig.

[0187] 1A, and otherwise herein. Fig. 12 shows a portion of console 300 including a set of energy pulse generators, comprising energy pulse generators 3 lOa-d. Each energy pulse generator can be operably (e.g., optically) attached to connector assembly 350, such as via a conduit, optical conduits 351a-d shown. Energy delivery catheter 100 can include connector assembly 150 that operably attaches energy delivery catheter 100 to console 300, such as to operably attach each energy pulse generator 310 to one or more fibers 1101 of energy delivery core 110.

[0188]

[0174] In some embodiments, system 10 is configured to deliver one or more energy pulses, pulses 315, to one or more target locations, such as to generate one or more bubbles BV, as Attorney Docket No. GYT-027-PCT described herein. In some embodiments, energy delivery core 1 10 comprises one or more fiber bundles, each comprising one or more fibers 1101, such as fibers 1 lOla-d of fiber bundle 1105. Fiber bundle 1105 can be configured to deliver multiple pulses 315 from multiple energy pulse generators 310 to a target location, such as to deliver a cumulative pulse comprising an energy level greater than a single pulse 315. In some embodiments, the maximum energy that can be provided by a single pulse 315 is limited by the physical limitations of a single fiber 1101 and / or a single energy pulse generator 310. Using multiple fibers 1101 and / or multiple energy pulse generators 310 to simultaneously deliver multiple pulses 315 to a target location can generate a larger bubble BV than can be achieved with a single generator and / or fiber. In some embodiments, a single fiber is no more than 250pm in diameter. In some embodiments, a single energy pulse generator is limited to no more than 400W. In some embodiments, each energy pulse generator 310 comprises a peak power output of approximately 300W. Each energy pulse generator 310 can comprise an NA of approximately 0.22 and / or an optical core of approximately 105p. Fibers 1101 can similarly comprise a core of approximately 105p and / or an NA of approximately 0.22 (e.g., the core size and / or NA of fibers 1101 can match the core size and / or NA of the attached energy pulse generator 310). In some embodiments, connector assemblies 350 and 150 can provide a connection with a power loss (e.g., power loss of pulse 315 due to alignment of optical components or other factors) of no more than 10%, such as no more than 8% power loss.

[0189]

[0175] System 10 can be configured to maximize pressure gradient TPG that is generated within target material by maximizing the potential energy of bubble BV that is created by the delivery of pulse 315 to the target location. The potential energy of bubble BV is limited by the energy delivered (e.g. the percentage of energy of one or more pulses 315 that is effectively delivered) to the target location to cause the formation of bubble BV. In some embodiments, two or more energy pulse generators 310 are optically coupled to one fiber 1101, such as to deliver two or more pulses 315 simultaneously (e.g., one pulse 315 from each pulse generator 310). In some embodiments, system 10 is configured to use wavelength dispersion multiplexing to increase the power that can be delivered by each fiber 1101, for example when two pulses 315 are delivered via a single fiber 1101. Wavelength multiplexed pulses 315 can comprise a wavelength difference of at least 5%. Attorney Docket No. GYT-027-PCT

[0190]

[0176] In some embodiments, system 10 is configured to deliver one or more pulses 315 to generate bubbles BV based on one or more “recipes” of settings and / or configurations. An example of a recipe for a single pulse energy delivery can comprise a 3ps pulse duration with a frequency of 10-100Hz. Delivered from a single emitter assembly 115, this recipe can generate a bubble BV capable of generating a pressure wave between 150atm and 200atm. Delivered from multiple emitters 115, this recipe can generate a bubble BV capable of generating a pressure wave of at least 300atm. An example of a recipe for a burst of pulses 315 can comprise a 4ps to 6ps pulse duration with 5 to 10 pulses per burst, a 25kHz to 45kHz frequency within the burst, and a 10Hz to 50Hz burst repetition frequency. Delivered from a single emitter 115, this recipe can generate a bubble BV capable of generating a pressure wave between 200atm and 230atm.

[0191]

[0177] Referring now to Figs. 13 A through 13F, schematic views of various embodiments of an emitter assembly are illustrated, respectively, consistent with the present inventive concepts. Energy delivery core 110, and / or other components of system 10 described in reference to Figs. 13 A through 13F can be of similar construction and arrangement as the similar components described in reference to Fig. 1, Fig. 1A, and otherwise herein. Figs. 13A through 13F show various embodiments of emitter assembly 115, with pulse 315 extending through fiber 1101 of energy delivery core 110, and extending to a target location where bubble BV forms (e.g., to the center of bubbles BV shown).

[0192]

[0178] Fig. 13A shows an embodiment of emitter assembly 115 including reflector 1155 that comprises an angle grind that is polished into the distal end of fiber 110. Emitter assembly 115 can comprise a housing, housing 1157 shown, that is configured to hold a material (e.g., air) distal to reflector 1155, such as to provide a glass-air interface for reflector 1155 (e.g., for internal reflection of pulse 315.

[0193]

[0179] Fig. 13B shows an embodiment of emitter assembly 115 comprising an angled distal portion of fiber 1101 (e.g., a bent portion configured to orient the distal end of fiber 1101 toward the target location). In some embodiments, the distal end of fiber 1101, face 1156, is configured to emit pulse 315 axially from fiber 1101 (e.g., to focus pulse 315 to a location axially displaced from face 1156, as shown).

[0194]

[0180] Fig. 13C shows an embodiment of emitter assembly 115 including reflector 1155 that comprises an angle grind that is polished into the distal end of fiber 110. Reflector 1155 can Atorney Docket No. GYT-027-PCT comprise a mirrored surface, for example when reflector 1 155 comprises a mirrored coating, coating 1152. Reflector 1155 can comprise an angle of approximately 45°, as shown.

[0195]

[0181] Fig. 13D shows an embodiment of emitter assembly 115 with reflector 1155 comprising a mirrored prism that is fixedly attached to the distal end of fiber 1101.

[0196]

[0182] In some embodiments, energy delivery core 110 is configured to focus pulse 315 proximate the wall of an energy distributor, such as balloon 2101 (e.g., within balloon 2101 proximate the wall), such that bubble BV is generated proximate the wall of balloon 2101, for example as shown in Fig. 13E and Fig. 13F. For example, in Fig. 13E, fiber 1101 of energy delivery core 110 can be positioned along the wall of balloon 2101. Emitter 115 can comprise face 1156 of fiber 1101, that is configured to focus pulse 315 axially distal to fiber 1101, as shown. Fig. 13F shows fiber 1101 positioned along the wall of balloon 2101. Emitter assembly 115 can comprise reflector 1155, comprising an angled polish configured to focus pulse 315 away from the wall of balloon 2101, for example such that bubble BV forms proximate the wall of balloon 2101, but minimally interacts with the wall, as shown.

[0197]

[0183] Referring additionally to Figs. 14A through 14C, various arrangements of fiber bundles and emitter assemblies of the fiber bundles are illustrated, respectively, consistent with the present inventive concepts. Energy delivery core 110, and / or other components of system 10 described in reference to Figs. 14A through 14C can be of similar construction and arrangement as the similar components described in reference to Fig. 1, Fig. 1A, and otherwise herein. Fig. 14A shows side and end views of an embodiment of fiber bundle 1105 of energy delivery core 110. Fiber bundle 1105 can include two fibers 1101, each including reflector 1155. Reflectors 1155 can be aligned and oriented to emit pulses 315 in opposite directions from the central axis of energy delivery core 110 (e.g., 180° apart), at a single axial location, as shown. Fig. 14B shows side and end views of an embodiment of fiber bundle 1105 including four fibers 1101, each including reflector 1155. Reflectors 1155 can be aligned and oriented to emit pulses 315 in a radial pattern, such as a 90° pattern, in a single axial location, as shown. Fig. 14C shows side and end views of an embodiment of fiber bundle 1105 including four fibers 1101, each including reflector 1155. Reflectors 1155 can be aligned and oriented to emit pulses 315 in a radial patter, such as a 90° pattern, where each pulse is axially offset, such as offset distances DI, D2, and D3, as shown. In some embodiments, distances D1-D3 comprise a distance of approximately 3mm. Attorney Docket No. GYT-027-PCT

[0198]

[0184] Referring now to Fig. 15, an optical schematic of an optical pathway of an energy delivery system where the optical pathway includes a circulator is illustrated, consistent with the present inventive concepts. Console 300 and / or other components of system 10 described in reference to Fig. 15 can be of similar construction and arrangement as the similar components described in reference to Fig. 1, Fig. 1A, and otherwise herein. Console 300 can include energy pulse generator 310 that provides pulse 315 to energy delivery core 110 for delivery to a target location as described herein. Console 300 can include one or more optical components operably attached between energy pulse generator 310 and energy delivery core 110, these components comprising an optical path, optical path 311. In some embodiments, optical path 311 comprises one or more components configured to maximize the amount of energy from pulse 315 that is emitted from emitter assembly 115 of energy delivery core 110. For example, optical path 311 can include a splitter, splitter 3111, and an optical circulator, circulator 3112. Fiber 1101 can comprise emitter 115, such as emitter 115 comprising a portion of fiber 1101 with a Bragg grating, Bragg emitter 1158 shown. In some embodiments, fiber 1101 can include a reflector distal to Bragg emitter 1158, reflector 1159. Reflector 1159 can be configured to reflect energy of pulse 315 that is not emitted by emitter 115 (e.g., due to low extraction efficiency of Bragg emitter 1158). In some embodiments, reflector 1159 comprises a Bragg reflector.

[0199]

[0185] Energy reflected by reflector 1159 can return proximally along fiber 1101 to circulator 3112 and can be redirected back toward emitter 115 through splitter 3111. In some embodiments, the total roundtrip length from energy pulse generator 310 to reflector 1159 and back to circulator 3112 is less than 6 meters. In some embodiments, Bragg emitter 1158 is configured to operate bidirectionally, such as to emit a portion of pulse 315 traveling distally and proximally (e.g., after reflection of pulse 315 from reflector 1159). In some embodiments, Bragg emitter 1158 is approximately 10% efficient (e.g., 10% of the energy of a pulse 315 traveling through the emitter in either direction is emitted). In some embodiments, pulse 315 circulates approximately 20 cycles such that at least 99% of pulse 315 has been emitted by emitter assembly 115.

[0200]

[0186] Referring now to Fig. 16, a perspective view of an embodiment of a fiber cap lens assembly is illustrated, consistent with the present inventive concepts. Fiber cap 116 and / or other components of system 10 described in reference to Fig. 16 can be of similar construction and arrangement as the similar components described in reference to Fig. 1, Fig. 1 A, and Attorney Docket No. GYT-027-PCT otherwise herein. Fiber cap 116 can include body 1161, with port 1 162 on the proximal end of body 1161. In some embodiments, fiber cap 116 comprises a portion of emitter assembly 115, for example fiber cap 116 can include one or more energy redirecting and / or focusing elements, lens 1164 shown. In some embodiments, port 1162 comprises a non-circular shape, such as a shape that is configured to align one or more fibers of a fiber bundle (e.g., one or more fibers 1101 of a fiber bundle 1105, described herein). The geometry of port 1162 can be configured to align the distal end of one or more fiber 1101 with lens 1164. In some embodiments, lens 1164 comprises a metalized reflector or other reflector. Lens 1164 can be angled relative to port 1162, for example to direct pulse 315 away from the central axis of fiber 1101 (e.g., a 45° angle to reflect pulse 315 90°). As shown, lens 1164 would reflect pulse 315 “out of the page”.

[0201]

[0187] In any embodiment, all or part of the emitter assembly (e.g., including any lens body, reflector housing, prism, or other structure as described herein) may be formed using one or more of a machining, molding, or additive manufacturing (e.g., 3D printing) processes. In some embodiments, an emitter assembly may be formed as a monolithic 3D printed structure configured to receive the distal end of an optical core and to direct and / or focus light from the optical core toward one or more target locations. In other embodiments, 3D printed features may be used to define internal channels, curved optical surfaces, or alignment structures that position the optical core and associated optical surfaces relative to a balloon or shaft.

[0202]

[0188] The above-described embodiments should be understood to serve only as illustrative examples; further embodiments are envisaged. Any feature described herein in relation to any one embodiment may be used alone, or in combination with other features described, and may also be used in combination with one or more features of any other of the embodiments, or any combination of any other of the embodiments. Furthermore, equivalents and modifications not described above may also be employed without departing from the scope of the inventive concepts, which are defined in the accompanying claims.

Claims

Attorney Docket No. GYT-027-PCTCLAIMS1. A system for performing intravascular lithotripsy on a patient, the system comprising: a catheter comprising: an energy delivery core, comprising an optical core; an optical energy emitter coupled to the energy delivery core; and a first connector assembly operably attached to the energy delivery core; and a console comprising: an energy pulse generator configured to generate an energy pulse; and a second connector assembly configured to operably couple the energy pulse to the energy delivery core, wherein the energy emitter is configured to deliver the energy pulse to a target location that is located proximate to a target material, wherein the energy pulse is configured to generate a pressure wave within the target material, and wherein the pressure wave is configured to treat the target material.

2. The system according to claim 1, wherein the catheter comprises a shaft with a diameter of no more than 0.044 inches.

3. The system according to claim or claim 2, wherein the shaft comprises a diameter of no more than 0.032 inches.

4. The system according to any prior claim, wherein the energy delivery core comprises a diameter of no more than 0.014 inches.

5. The system according to any prior claim, wherein the pressure wave is configured to generate a peak therapeutic pressure of at least 200atm.Attorney Docket No. GYT-027-PCT6. The system according to any prior claim, wherein the optical core comprises cladding.

7. The system according to any prior claim, wherein the optical core comprises a multimode optical fiber.

8. The system according to any prior claim, wherein the optical core comprises a multi-core arrangement of two or more optical fibers.

9. The system according to any prior claim, wherein the energy delivery core comprises a tubular element surrounding the energy delivery core.

10. The system according to claim 9, wherein the tubular element comprises a metallization that is applied to the energy delivery core.

11. The system according to claim 9, wherein the tubular element comprises a set of patterned reliefs.

12. The system according to claim 11, wherein the set of patterned reliefs comprises one or more laser-cut reliefs.

13. The system according to any prior claimn, wherein the optical energy emitter comprises a wedge-based optical emitter comprising a relief.

14. The system according to claim 13, wherein the relief comprises one or more machined reliefs.

15. The system according to claim 14 , wherein the one or more machined reliefs comprise one or more laser machined reliefs.Attorney Docket No. GYT-027-PCT16. The system according to claim 15n, wherein the one or more laser machined reliefs comprise one or more pulsed-laser machine reliefs, such as when the reliefs are created using ultrashort pulsed-laser machining.

17. The system according to any one of claims 13-16, wherein the relief comprises a depth and an angle, and wherein the depth and the angle of the relief are configured to control the deflection of one or more energy pulses delivered by the energy emitter.

18. The system according to any one of claims 3-17, wherein the relief comprises a metal coating.

19. The system according to any one of claims 13-18, wherein the relief is oriented proximally.

20. The system according to any one of claims 13-18, wherein the relief is oriented distally.

21. The system according to any one of claims 13-20, wherein the relief is constructed and arranged to cause total internal reflection.

22. The system according to any one of claims 13-21, wherein the catheter includes a shaft and wherein the relief is created through a window in the shaft.

23. The system according to any prior claim, wherein the optical energy emitter comprises a leaky portion of the energy delivery core.

24. The system according to claim 23, wherein the leaky portion comprises a portion created using an ablating and / or a machining manufacturing process.

25. The system according to any prior claim, wherein the optical energy emitter comprises one or more scattering defects of the energy delivery core.Attorney Docket No. GYT-027-PCT26. The system according to any prior claim, wherein the optical energy emitter comprises a lens configured to focus the energy pulse.

27. The system according to claim 26, wherein the lens is created using an additive manufacturing (e.g., 3D printing) process.

28. The system according to any prior claim, wherein the energy emitter comprises a Bragg grating portion of the energy delivery core.

29. The system according to claim 28, wherein the Bragg grating portion comprises a portion created with femtosecond laser processing.

30. The system according to any prior claim, wherein the energy pulse generator is configured to generate multiple energy pulses and wherein the energy emitter is configured to deliver the multiple energy pulses.

31. The system according to claim 30, wherein the energy emitter is configured to deliver the multiple energy pulses without translating the energy delivery core and / or without rotating the energy delivery core.

32. The system according to any prior claim, wherein the energy emitter comprises a tapered portion of the energy delivery core.

33. The system according to claim 32, wherein the tapered portion comprises a narrow taper configured to create a point emission of the energy pulse.

34. The system according to claim 32, wherein the tapered portion comprises a long taper configured to create a distributed emission of the energy pulse.

35. The system according to any one of claims 32-34, wherein the tapered portion is configured to focus the energy pulse into a ring of light.Attorney Docket No. GYT-027-PCT36. The system according to claim 35 and / or any one or more other claims herein, wherein the ring of light is configured to create a torus-shaped bubble.

37. The system according to any one of claims 32-36, wherein the tapered portion comprises a GRIN portion configured to direct or focus the energy pulse.

38. The system according to claim 37, wherein the GRIN portion is created using an additive manufacturing (e.g., 3D printing) process.

39. The system according to claim 38, wherein the GRIN portion is configured to create a point emission of the energy pulse.

40. The system according to claim 38 or claim 39, wherein the GRIN portion is configured to create at least one ring of light.

41. The system according to claim 40 and / or any one or more other claims herein, wherein the GRIN portion is configured to create multiple rings of light.

42. The system according to any prior claim, wherein the optical energy emitter comprises two or more optical energy emitters.

43. The system according to claim 42, wherein the system is configured to create multiple simultaneous pressure waves.

44. The system according to claim 43, wherein the system is configured to treat a longitudinal portion of the target material without rotation and / or without translation of the energy emitter.

45. The system according to any one of claims 42-44, wherein the two or more optical emitters are distributed axially along the energy delivery core.Attorney Docket No. GYT-027-PCT46. The system according to any one of claims 42-44, wherein the two or more optical emitters are distributed radially along the energy delivery core.

47. The system according to any prior claim, wherein the energy pulse comprises one or more pulses of light.

48. The system according to any prior claim, wherein the energy pulse is configured to generate one or more bubbles, and wherein the one or more bubbles are configured to generate a pressure wave.

49. The system according to claim 48, wherein the one or more bubbles comprise one or more spherical bubbles.

50. The system according to claim 48 or claim 49, wherein the pressure wave comprises at least two pressure waves.

51. The system according to claim 50, wherein a first pressure wave is generated by bubble expansion and a second pressure wave is generated by bubble collapse.

52. The system according to claim 51, wherein the first pressure wave is generated by a first energy level and the second pressure wave is generated by a second energy level, and wherein the first energy level is greater than the second energy level.

53. The system according to claim 51, wherein the system is configured to minimize the second pressure wave.

54. The system according to any prior claim, wherein the console comprises a translation module configured to cause translation of at least the energy emitter.Attorney Docket No. GYT-027-PCT55. The system according to any prior claim, wherein the console comprises a rotation module configured to cause rotation of at least the energy emitter.

56. The system according to any prior claim, wherein the catheter comprises an expandable balloon, and wherein the console comprises a balloon fill assembly configured to deliver flowable material to the expandable balloon, and wherein the expandable balloon is configured as an energy distributor when filled with the flowable material.

57. The system according to claim 56, wherein the balloon fill assembly includes a first sensor comprising a pressure sensor, a flow sensor, and / or other sensor, wherein the first sensor is configured to produce a sensor signal, and wherein the balloon fill assembly is configured to deliver the flowable material to and / or extract the flowable material from the expandable balloon in a closed loop arrangement based on the sensor signal.

58. The system according to claim 57n, wherein the first sensor is located in the expandable balloon.

59. The system according to claim 57, wherein the first sensor is located in the console.

60. The system according to any one of claims 56-59, wherein the fill assembly is configured to maintain constant pressure in the expandable balloon based on the sensor signal.

61. The system according to any one of claims 56-60, wherein the fill assembly is configured to monitor changes in pressure in the expandable balloon.

62. The system according to claim 61, wherein the changes in pressure comprise changes in pressure that result due to calcium fracture.

63. The system according to any one of claims 56-62, wherein the console is configured to monitor the expandable balloon via information received from an imaging device.Attorney Docket No. GYT-027-PCT64. The system according to any one of claims 56-63, wherein the console is configured to monitor the size and / or the shape of the expandable balloon.

65. The system according to claim 63, wherein the information comprises OCT-based imaging information.

66. The system according to claim 65, wherein the catheter is configured to produce the OCT-based imaging information.

67. The system according to any prior claim, wherein the console further comprises a contrast delivery assembly.

68. The system according to any prior claim, wherein the catheter further comprises an energy distributor, such as an expandable balloon configured to distribute energy.

69. The system according to claim 68, wherein the energy distributor is configured to receive a flowable material, and wherein the flowable material receives the energy pulse when the energy distributor is positioned proximate the target material.

70. The system according to claim 69, wherein the flowable material is selected from the group consisting of: indocyanine green dye (ICG); RO contrast; saline; and combinations thereof.

71. The system according to 69 or claim 70, wherein the flowable material comprises one or more materials that are selected based on the properties of the energy pulse.

74. The system according to claim 71, wherein the properties of the energy pulse comprise the wavelength of the energy pulse.Attorney Docket No. GYT-027-PCT75. The system according to any one of claims 69-74, wherein the flowable material comprises multiple materials that are delivered to the energy distributor via multiple syringes and / or multiple reservoirs.

76. The system according to claim any one of claims 68-75, wherein the energy emitter is positioned within the energy distributor.

77. The system according to any one of claims 68-76, wherein the energy distributor comprises a balloon, such as a cutting balloon.

78. The system according to any one of claims 68-77, wherein the energy distributor comprises a treatment element selected from the group consisting of: balloon; cutting balloon; atherectomy element; sharp blade; laser; rotating device; and combinations thereof.

79. The system according to any one of claims 68-78, wherein the energy distributor comprises a balloon that is fdled to a target pressure.

80. The system according to claim 79, wherein the target pressure comprises a pressure of no more than 4atm.

81. The system according to any prior claim, wherein the catheter comprises a first catheter, and wherein the system further comprises a second catheter configured to slidingly receive the first catheter.

82. The system according to claim 81, wherein the second catheter comprises a set of catheters with different dimensions and / or other different properties.

83. The system according to claim 82, wherein the different dimensions comprise different diameters and / or different lengths.Attorney Docket No. GYT-027-PCT84. The system according to any one of claims 81-83, wherein the second catheter comprises a balloon.

85. The system according to any one of claims 81-84, wherein the first catheter comprises a diameter of no more than 0.014 inches.

86. The system according to any one of claims 81-85, wherein the second catheter is configured to be transluminally advanced over the first catheter.

87. The system according to any prior claim, wherein the catheter comprises a marker.

88. The system according to claim 87, wherein the marker comprises a radiopaque marker.

89. The system according to claim 87 or claim 88, wherein the marker indicates an emission region of the catheter.

90. The system according to any prior claim, wherein the first connector assembly comprises a self-cleaning connector assembly.

91. The system according to claim 90, wherein the first connector assembly is configured to clean a surface of the energy delivery core.

92. The system according to any one of claims 90-92, wherein the first connector assembly is configured to clean an optical connection.

93. The system according to any one of claims 90-92, wherein the first connector assembly comprises a wiper configured to clean a surface of the energy delivery core.

94. The system according to any one of claims 90-93, wherein the first connector assembly is configured to perform a cleaning operation using a jet of gas.Attorney Docket No. GYT-027-PCT95. The system according to claim 94, wherein the jet of gas is created via connecting of the first connector assembly to the energy delivery core.

96. The system according to any prior claim, wherein the first connector assembly comprises an identifier.

97. The system according to claim 96, wherein the identifier comprises an RF identifier.

98. The system according to claim 96 or claim 97, wherein the identifier is configured to record uses, number of energy pulses delivered, and / or calibration information.

99. The system according to claim 98, wherein the system is configured to monitor total delivered energy.

100. The system according to claim 98 or claim 99, wherein the system is configured to provide an alert when use of the energy delivery core exceeds a threshold.

101. The system according to any prior claim, wherein the first connector assembly is configured to removably attach to the energy delivery core.

102. The system according to claim 101, wherein the first connector assembly comprises a diameter of no more than 0.014 inches.

103. A method of performing intravascular lithotripsy on a patient, comprising generating a pressure wave that is configured to treat target material of the patient, using a system as described in any prior claim.

104. The method according to claim 103, further comprising: delivering the catheter through a body lumen; positioning the optical energy emitter proximate the target material; and delivering an energy pulse to a target location,Attorney Docket No. GYT-027-PCT wherein the delivering of the energy pulse generates the pressure wave.

105. The method according to claim 104 or claim 105, wherein the target material comprises calcific plaque and / or one or more other materials associated with the narrowing of a blood vessel.

106. The method according to any one of claims 103-105, further comprising delivering an energy pulse to a target location, wherein the energy pulse creates a bubble that generates the pressure wave.

107. The method according to claim 106, wherein the bubble comprises a rapidly expanding and / or rapidly collapsing bubble.

108. The method according to claim 107, wherein the pressure wave comprises a first pressure wave formed by the bubble expanding and a second pressure wave formed by the bubble collapsing.

109. The method according to claim 108, wherein the first pressure wave comprises more energy than the second pressure wave.

110. The method according to claim claim 108 or claim 109, further comprising suppressing the second pressure wave.

111. The method according to any one of claims 106-110, wherein the bubble comprises a non-symmetric shape.

112. The method according to any one of claims 106-110, wherein the bubble comprises a spherical shape.Attorney Docket No. GYT-027-PCT113. The method according to any one of claims 104-112 and / or any one or more other claims herein, further comprising removing residual microbubbles between a first energy delivery and a second energy delivery.

114. The method according to any one of claims 104-113, further comprising delivering a second energy pulse to a second target location, wherein the second energy pulse creates a second bubble that generates a second pressure wave.

115. The method according to claim 114 and / or any one or more other claims herein, wherein the second energy pulse is delivered to the second target location without rotating and / or translating the energy emitter.

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