WO2025132535A1

WO2025132535A1 - Translational laser-based device to generate sonic pressure waves in a balloon catheter

Info

Publication number: WO2025132535A1
Application number: PCT/EP2024/087036
Authority: WO
Inventors: Arjen VAN DER HORST; James David CEZO; Chad Perrin; Elodie Delassus
Original assignee: Koninklijke Philips NV
Current assignee: Koninklijke Philips NV
Priority date: 2023-12-21
Filing date: 2024-12-18
Publication date: 2025-06-26
Anticipated expiration: 2026-06-21

Abstract

A medical device includes an inflatable balloon adapted to be deployed in a balloon catheter. The inflatable balloon is disposed along an axis and is adapted to receive a contrast agent therein. The medical device also includes an inflation lumen adapted to inflate and deflate the balloon. The inflation lumen is disposed in a direction substantially parallel to the axis. An optical fiber is disposed in the inflation lumen and has a distal end. The optical fiber is adapted to translate along in the direction. When light of a selected wavelength from a laser is emitted from the distal end of the optical fiber, a photochemical reaction occurs in the contrast agent and creates a shock wave adapted to break a lesion comprising calcium in a blood vessel.

Description

TRANSLATIONAL LASER-BASED DEVICE TO GENERATE SONIC PRESSURE WAVES IN A BALLOON CATHETER

BACKGROUND

[0001] Angioplasty is ubiquitous in many medical treatments today and involves deploying a balloon in an artery or vein that is diseased, and inflating the balloon. In one common application, angioplasty is a procedure used to open blocked arteries, such as blocked coronary arteries caused by coronary artery disease. The deployed balloon may be used restore blood flow to the heart muscle without open-heart surgery, and allows for components, such as stents, to be deployed after the artery is open.

[0002] Calcification in blood vessels and other vessels of the body can cause blockages, which if not addressed, can have catastrophic effects. As such, removal of calcification in endovascular recanalization procedures a goal in improving vascular health. There are currently several devices for calcium modification in preparation for stenting.

[0003] One known method includes use of a balloon catheter a balloon catheter with electrodes elements at fixed locations inside the balloon. Upon application of an electrical voltage across the electrodes, a spark is created and a sonic pressure wave is generated to crack calcium. The balloon has reduced deliverability compared to a regular balloon. Atherectomy to clear a channel in the lesion is often performed prior to Intravascular lithotripsy (IVL). Because the electrodes are disposed at fixed locations, the spark gaps are also at fixed locations preventing the delivery at multiple calcium spots without repositioning the balloon. Moreover, this method requires the removal of an initially deployed known compliant or non-compliant balloon prior to the introduction of the specialized IVL balloon with the fixed electrodes needed to carry out the procedure. As will be appreciated, in addition to the limited applicability because of the fixed location of the electrodes and the need for a specialty balloon to carry out the treatment on calcification sites, this known method stifles good work-flow because of the need to remove and introduce multiple balloons to complete the treatment session.

[0004] What is needed, therefore, is a system and method for angioplasty of calcified lesions that overcomes at least the noted drawbacks of the known approaches described above. SUMMARY

[0005] In accordance with a representative embodiment, a medical device, comprises an inflatable balloon adapted to be deployed in a balloon catheter. The inflatable balloon is disposed along an axis and is adapted to receive a contrast agent therein. The medical device also comprises an inflation lumen adapted to inflate and deflate the balloon. The inflation lumen is disposed in a direction substantially parallel to the axis. An optical fiber is disposed in the inflation lumen and has a distal end. The optical fiber is adapted to translate along in the direction. When light of a selected wavelength from a laser is emitted from the distal end of the optical fiber, a photochemical reaction occurs in the contrast agent and creates a shock wave adapted to break a lesion comprising calcium in a blood vessel.

[0006] In accordance with another representative embodiment, a medical device comprises an inflatable balloon adapted to be deployed in a balloon catheter. The inflatable balloon is disposed along an axis and is adapted to receive a contrast agent therein. The medical device also comprises an inflation lumen adapted to inflate and deflate the balloon. The inflation lumen is disposed in a direction substantially parallel to the axis. The medical device also comprises an optical fiber disposed in a guidewire lumen. The optical fiber has a distal end, and the optical fiber is adapted to translate along in the direction. When light of a selected wavelength from a laser is emitted from the distal end of the optical fiber, a photochemical reaction occurs in the contrast agent and creates a shock wave adapted to break a lesion comprising calcium in a blood vessel.

BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The example embodiments are best understood from the following detailed description when read with the accompanying drawing figures. It is emphasized that the various features are not necessarily drawn to scale. In fact, the dimensions may be arbitrarily increased or decreased for clarity of discussion. Wherever applicable and practical, like reference numerals refer to like elements.

[0008] Fig. 1 is a simplified block diagram of a system for thermal balloon angioplasty, in accordance with a representative embodiment.

[0009] Fig. 2A is a simplified block diagram a medical system adapted to incorporate a medical device in accordance with a representative embodiment.

[0010] Fig. 2B is a perspective view of a medical device in accordance with a representative embodiment.

[0011] Fig. 2C is a conceptual view of a medical device deployed for treatment of a patient in accordance with a representative embodiment.

[0012] Fig. 2D is a close-up view of the portions of the medical device of Fig. 2C in accordance with a representative embodiment.

[0013] Fig. 2E is a close-up view of the portions of a medical device in accordance with another representative embodiment.

[0014] Fig. 3 is a partial cut-away of a medical device deployed in a scoring balloon in accordance with another representative embodiment.

[0015] Fig. 4 is a method of generating shock waves to disintegrate calcification in a vessel in accordance with a representative embodiment.

DETAILED DESCRIPTION

[0016] In the following detailed description, for the purposes of explanation and not limitation, representative embodiments disclosing specific details are set forth in order to provide a thorough understanding of embodiments according to the present teachings. However, other embodiments consistent with the present disclosure that depart from specific details disclosed herein remain within the scope of the appended claims. Descriptions of known systems, devices, materials, methods of operation and methods of manufacture may be omitted so as to avoid obscuring the description of the representative embodiments. Nonetheless, systems, devices, materials and methods that are within the purview of one of ordinary skill in the art are within the scope of the present teachings and may be used in accordance with the representative embodiments. It is to be understood that the terminology used herein is for purposes of describing particular embodiments only and is not intended to be limiting. Definitions and explanations for terms herein are in addition to the technical and scientific meanings of the terms as commonly understood and accepted in the technical field of the present teachings. [0017] It will be understood that, although the terms first, second, third etc. may be used herein to describe various elements or components, these elements or components should not be limited by these terms. These terms are only used to distinguish one element or component from another element or component. Thus, a first element or component discussed below could be termed a second element or component without departing from the teachings of the inventive concept. [0018] As used in the specification and appended claims, the singular forms of terms ‘a’, ‘an’ and ‘the’ are intended to include both singular and plural forms, unless the context clearly dictates otherwise. Additionally, the terms “comprises,” and/or “comprising,” and/or similar terms when used in this specification, specify the presence of stated features, elements, and/or components, but do not preclude the presence or addition of one or more other features, elements, components, and/or groups thereof. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

[0019] Unless otherwise noted, when an element or component is said to be “connected to”, “coupled to”, or “adjacent to” another element or component, it will be understood that the element or component can be directly connected or coupled to the other element or component, or intervening elements or components may be present. That is, these and similar terms encompass cases where one or more intermediate elements or components may be employed to connect two elements or components. However, when an element or component is said to be “directly connected” or “immediately adjacent” to another element or component, this encompasses only cases where the two elements or components are connected or disposed immediately adjacent to each other without any intermediate or intervening elements or components.

[0020] As described herein in connection with various representative embodiments, a medical device and a method for breaking up (cracking) calcium deposits in a vessel are described. As described more fully below, an optical fiber is inserted into a compliant or non-compliant balloon. The optical fiber is adapted to be translated so that its distal end can be located at various locations in the vessel, and in proximity to a lesion. A contrast agent (e.g., an iodine- containing contrast medium or gadolinium contrast medium) is also introduced into the balloon, and upon emission of a specific wavelength of light from the distal end of the optical fiber, a photochemical reaction occurs that creates a shock wave in the balloon. The sonic energy created by the shock wave that causes the calcification to break up/disintegrate. Further details of the creation of sonic energy by inducing a photochemical reaction and resulting sonic pressure can be found in commonly owned U.S. Patent 10,201,387 to Grace, et al. and entitled “Laser- Induced Fluid Filled Balloon Catheter.” The entire disclosure of U.S. Patent 10,201,387 is specifically incorporated herein by reference.

[0021] As will be appreciated as the present description continues, the ability to translate the distal end of the optical fiber allows it to be moved to the locations where calcification is present while the balloon is being pressurized. As described more fully below, the optical fiber of medical devices of various representative embodiments can be inserted into a contrast/inflation port, translated/moved within the catheter down to the balloon into the location with calcium to apply the therapy, moved again to another location to apply the therapy without the need to move/replace the balloon. By locating the distal end of the optical fiber to be sufficiently proximate to calcifications at various locations, the medical devices of various representative embodiments allow for multiple applications of shock waves in the same medical procedure, using the same balloon that is used to carry out the remainder of the procedure. By contrast to other known methods, the medical devices of the present teachings enable to translating of the optical fiber to move the location of the treatment to crack various calcifications in a vessel in the same workflow. In addition to the enabling the treatment of calcifications in selected locations in a vessel, in contrast to a known device, the present teachings do not require the initially deployed balloon to be removed, a specialty balloon to be inserted to carry out the treatment, the specialty balloon to be removed, and another balloon to be reintroduced to carry on further treatment. As will be appreciated, in addition to reducing both the labor and component costs, the medical devices of the present teachings improve workflow of the treatment of calcifications in vessels.

[0022] It is noted that while representative embodiments focus on applications of the present teachings to diagnosis and treatment of diseased peripheral arteries having calcification deposits therein, this is merely illustrative. More generally, the medical devices methods of the representative embodiments may be used in the diagnosis and treatment of diseased arteries (e.g., coronary arteries) and other vessels in a body. Just by way of illustration, the present teachings contemplate applications to disintegrate kidney stones in renal vessels in the body where they can occur.

[0023] Fig. 1 illustrates a medical system 100 is a simplified block diagram of a system for balloon angioplasty in calcified vessels in accordance with a representative embodiment.

[0024] The medical system 100 comprises a medical device 101 comprising a balloon catheter (not shown in Fig. 1) adapted to be expanded in a vessel. The medical device 101 also comprises a translatable optical fiber (not shown in Fig. 1) having a distal end adapted to emit light from a laser (not shown in Fig. 1) at specific locations along a balloon in which it is deployed. The emission of light causes a photochemical reaction with a contrast agent in the balloon that results in a shock wave that breaks up calcium deposits in the vessel.

[0025] The system further comprises a controller 150. The controller 150 comprises a processor 153. The controller 150 also comprises a memory 151 that store computer-executable instructions (code) and medical data. Notably, the use of separate memories is merely illustrative, and fewer or more memories are contemplated. In accordance with representative embodiments described more fully below, these instructions, when executed by the processor 153 carry out various functions of representative embodiments described herein. As such, the memory 151 may store a set of software instructions that can be executed to cause the medical system 100 to perform some or all aspects of certain methods or computer-based functions.

[0026] The controller 150 may be implemented by a computer that includes more elements than the controller 150 in Fig. 1. Notably, in accordance with a representative embodiment, the controller 150 is remote to the medical system 100, and is adapted to control various aspects of the medical system 100 remotely via connections including both wired and wireless connections and protocols. In this sense, the controller 150, at least in part is a specialty or particular computer useful in controlling the medical system 100.

[0027] The controller 150 may operate as a standalone device or may be connected, for example, using a network to other computer systems or peripheral devices. In representative embodiments, the medical system 100 performs logical processing based on digital signals received via an analog-to-digital converter. The controller 150 can also be implemented as or incorporated into various devices, such as a workstation that includes a controller, a stationary computer, a mobile computer, a personal computer (PC), a laptop computer, a tablet computer, or any other machine capable of executing a set of software instructions (sequential or otherwise) that specify actions to be taken by that machine. The controller 150 can be incorporated as or in a device that in turn is in an integrated system that includes additional devices. In an embodiment, the controller 150 can be implemented in a device that also provides video or data communication. Moreover, the controller 150 may be connected to components of the system via a local wired interface such as an Ethernet cable or via a local wireless interface such as a Wi-Fi connection.

[0028] The processor 153 may be considered a representative example of a processor of the controller 150 and executes instructions to implement some or all aspects of methods and processes described herein. The processor 153 is tangible and non-transitory. As used herein, the term “non-transitory” is to be interpreted not as an eternal characteristic of a state, but as a characteristic of a state that will last for a period. The term “non-transitory” specifically disavows fleeting characteristics such as characteristics of a carrier wave or signal or other forms that exist only transitorily in any place at any time. The processor 153 is an article of manufacture and/or a machine component. The processor 153 is configured to execute software instructions to perform functions as described in the various embodiments herein. The processor 153 may be a general-purpose processor or may be part of an application specific integrated circuit (ASIC). The processor 153 may also be a microprocessor, a microcomputer, a processor chip, a controller, a microcontroller, a digital signal processor (DSP), a state machine, or a programmable logic device. The processor 153 may also be a logical circuit, including a programmable gate array (PGA), such as a field programmable gate array (FPGA), or another type of circuit that includes discrete gate and/or transistor logic. The processor 153 may be a central processing unit (CPU), a graphics processing unit (GPU), or both. Additionally, any processor described herein may include multiple processors, parallel processors, or both. Multiple processors may be included in, or coupled to, a single device or multiple devices.

[0029] The term “processor” as used herein encompasses an electronic component able to execute a program or machine executable instruction. References to a processor should be interpreted to include more than one processor or processing core, as in a multi-core processor. A processor may also refer to a collection of processors within a single computer system or distributed among multiple computer systems.

[0030] The memory 151 and may include a main memory and/or a static memory, where memories in the medical system 100 communicate with each other and the processor 153 via a bus. The memory 151 may be considered a representative example of a memory of the controller 150, and store instructions used to implement some or all aspects of methods and processes described herein. Memories described herein are tangible storage mediums for storing data and executable software instructions and are non-transitory during the time software instructions are stored therein. As used herein, the term “non-transitory” is to be interpreted not as an eternal characteristic of a state, but as a characteristic of a state that will last for a period. The term “non- transitory” specifically disavows fleeting characteristics such as characteristics of a carrier wave or signal or other forms that exist only transitorily in any place at any time. The memory 151 is an article of manufacture and/or machine components. The memory 151 is a computer-readable medium from which data and executable software instructions can be read by a computer (e.g., by the processor 153 of the controller 150). The memory 151 may be implemented as one or more of random access memory (RAM), read only memory (ROM), flash memory, electrically programmable read only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), registers, a hard disk, a removable disk, tape, compact disk read only memory (CD-ROM), digital versatile disk (DVD), floppy disk, blu-ray disk, or any other form of storage medium known in the art. The memory may be volatile or non-volatile, secure and/or encrypted, unsecure and/or unencrypted. The inventive concepts also encompass a computer readable medium that stores instructions that cause a data processing system (such as the DSP of an NVA) to execute the methods described herein. Finally, a computer readable medium is defined herein to be any medium that constitutes patentable subject matter under 35 U.S.C. §101 and excludes any medium that does not constitute patentable subject matter under 35 U.S.C. §101. Examples of such media include non-transitory media such as computer memory devices that store information in a format that is readable by a computer or data processing system. More specific examples of non-transitory media include computer disks and non-volatile memories.

[0031] Additionally, the memory 151 is an example of a computer-readable storage medium. Computer memory is any memory which is directly accessible to a processor. Examples of computer memory include, but are not limited to RAM memory, registers, and register files. References to “memory” should be interpreted as possibly being multiple memories. The memory may for instance be multiple memories within the same computer system. The memory may also be multiple memories distributed amongst multiple computer systems or computing devices. Software instructions, when executed by the processor 153, perform one or more steps of the methods and processes as described herein. In an embodiment, the software instructions may reside all or in part within the memory 151 and/or the processor 153 during execution by the controller 150.

[0032] The console 180 is local to the controller 150. In certain representative embodiments, the console 180 comprises a GUI and is connected to the controller 150 via a local wired interface such as an Ethernet cable or via a local wireless interface such as a Wi-Fi connection. As described more fully below, the console 180 may comprise a display, and through the GUI enables a user (e.g., a clinician/user) to provide inputs via the controller 150 to the medical device 101. Moreover, the console 180 be interfaced with other user input devices by which users can input instructions, including mouses, keyboards, thumbwheels and so on. The display of the console 180 may be a monitor such as a computer monitor, a display on a mobile device, an augmented reality display, a television, an electronic whiteboard, or another screen configured to display electronic imagery. The console 180 may also include one or more input interface(s) such as those noted above that may connect to other elements or components, as well as an interactive touch screen configured to display prompts to users and collect touch input from users. These interfaces may also be icons (not shown) on a display (not shown in Fig. 1) via the GUI.

[0033] The controller 150 may perform some of the operations described herein directly and may implement other operations described herein indirectly. For example, the controller 150 may indirectly control operations such as by generating and transmitting content to be displayed on the display 140. The controller 150 may directly control other operations such as logical operations performed by the processor 153 executing instructions from the memory 151 based on input received from electronic elements and/or users via the interfaces. Accordingly, the processes implemented by the controller 150 when the processor 153 executes instructions from the memory 151 may include steps not directly performed by the controller 150.

[0034] The medical system 100 also comprises and a console 180. As described more fully herein, the console 180 is a laser console comprising a laser (e.g., an Excimer laser) adapted to provide light of a particular wavelength, which when absorbed by a particular contrast agent in a balloon, causes a photochemical reaction. The photochemical reaction results in the release of sonic energy (e.g., a shock wave) that in turn breaks up calcium deposits in the vessel. As noted above, this phenomenon may be referred to as photoablation.

[0035] The medical system 100 also comprises an imaging system 160. As described more fully below, the imaging system is adapted to provide real-time images of the various components of the medical device 101 when deployed in a vessel. The imaging system comprises an imaging device (not shown) adapted to allow a clinician to view not only the components of the medical device 101, but also anatomical elements of the vessel in which the medical device 101 is disposed. In various representative embodiments, the imaging system 160 is a known fluoroscopic imaging device. This is merely illustrative, and other imaging systems are contemplated for use in the medical system 100. Generally, the imaging system selected enables the imaging of components of the medical device 101, and anatomical features where the medical device is deployed. For example, the imaging system may comprise an ultrasound (e.g., echography) imaging system or a magnetic resonance imaging system.

[0036] Among other functions, the imaging system 160 is adapted to show the positions of calcium deposits (calcifications) in the vessel, the optical fiber disposed in the balloon catheter, and the location of the distal end of the optical fiber. As alluded to above and described more fully below, the imaging system 160 allows a clinician to view the moving (translating) of the optical fiber (and thus its distal end) in the vessel, allowing the clinician to move the distal end of the optical fiber in proximity to calcifications in the vessel where the balloon is deployed before application of laser energy to cause the photochemical reaction and the desired sonic energy (e.g., shock wave) to be created to break up the calcification near the distal end of the optical fiber. As will be appreciated, the imaging system 160 is used to provide real-time images at other locations where the medical device 101 is deployed.

[0037] Fig. 2A is a simplified block diagram a medical system 200 adapted to incorporate a medical device in accordance with a representative embodiment. Various aspects and details of the medical system 100 described above in connection with the representative embodiments of Fig. 1 may be common to those of the presently described representative embodiment. These common aspects and details may not be repeated to avoid obscuring the presently described representative embodiments. [0038] The medical system comprises a structure 202 comprising a C-arm 204. An imaging device 205 is connected to the C-arm 204. The imaging device 205 is used to provide images of a portion of the anatomy of a patient 206 on a display 220 for the clinician to review during a procedure involving a medical device (not shown in Fig. 2A) inserted into the patient 206 via a catheter, as described more fully below. As noted above, the imaging device 205 may be a fluoroscope, an ultrasound imaging device, or other suitable device useful for providing images of the selected portion of the anatomy where the medical device is disposed. Just by way of illustration, the imaging device may be part of an Azurion Image Guided Therapy System commercially available from Koninklijke Philips N.V.

[0039] The medical system 200 also comprises a console 280 comprising an Excimer laser or similar source of optical energy used to cause the photochemical reaction that results in the shock wave for breaking up or disintegrating calcium deposits in the vessel of interest, as described more fully below. Just by way of example, the console may be Philips Nexcimer laser system commercially available from Koninklijke Philips N.V. The console 280 comprises an excimer laser system.

[0040] More generally, and in addition to the lasers described in the above-incorporated U.S. Patent to Grace, et al., the present teachings contemplate the use of excimer lasers or solid-state lasers capable of UV light generation having a wavelength in the range of 126nm-355nm. In certain embodiments the laser emits light having a wavelength in the range of approximately 300 nm-360 nm.

[0041] In certain embodiments, the pulse widths provided by excimer lasers are beneficially in the range of approximately Ins to approximately 150ns, with some embodiments providing pulses with widths in the range of approximately 100 ns to approximately 150 ns (e.g., via the above-noted commercially available Philips laser system). Furthermore, the repetition rate of the pulses is in the range of approximately 1 Hz to approximately 250 Hz.

[0042] Notably, the energy of the laser pulse should be greater than approximately 2.5 mJ. [0043] An alternative set of wavelengths contemplated by the present teachings in the nearinfrared (NIR) -infrared (IR) spectrum having a wavelength in the range of 750nm-2.3 pm. Pulse widths for this type of laser would be in the range of approximately Inm to approximately 25ns range with repetition rates from approximately! Hz to approximately 3000Hz. Notably, laser photons in these alternate wavelengths can produce a shockwave from interaction with water and do not need contrast agent in the balloon 232.

[0044] The display 220 of the imaging device 205 shows an image of a vessel 222 of the patient 206. As shown, the image on the display 220 shows a balloon catheter 230 with guidewire lumen 224 with a guidewire 228 disposed therein and extending past a balloon 225, which is shown being inflated with saline, or contrast agent, or both (not shown in Fig. 2A). An optical fiber 226 is provided in an inflation lumen (sometimes referred to as a contrast lumen) and has a distal end 227 disposed in the balloon 225.

[0045] The display 220 shows a lesion 229 in the vessel 222, which causes the balloon not to inflate to its full shape. This lesion 229 may contain calcifications. Notably, other lesions (not shown) may exist at other locations of the vessel 222. As alluded to above, and as described more fully below, the optical fiber 226 is adapted to translate in a direction (e.g., parallel to the x-axis of the coordinate system of Fig. 2A) in the vessel 222 so the distal end 227 is disposed near a lesion. Beneficially, the optical fiber 226 is disposed in a “regular” (known) compliant or non-compliant balloon, and is adapted to move so that multiple treatments with sonic energy can be carried out at the desired location near a calcified lesion without the need to replace the regular balloon with a “specialty” balloon required of certain known medical devices. Moreover, the optical fiber 226 may be introduced into the balloon 225 after initial deployment of the balloon 225 when a lesion is found in the vessel 222 via the imaging device 205. This allows a treatment to be carried out in-situ without having to terminate a procedure, remove the “typical” balloon, introduce a specialty balloon, perform the procedure, and reintroduce the “typical” balloon. Among improvements to work-flow, this reduces the cost of both materials/devices needed to treat a patient and reduces labor costs because of the ease of adaptability.

[0046] Fig. 2B is a perspective view of a medical device 201 in accordance with a representative embodiment. Various aspects and details of the medical devices described above in connection with the representative embodiments of Figs. 1 and 2 A may be common to those of the presently described representative embodiment. These common aspects and details may not be repeated to avoid obscuring the presently described representative embodiments.

[0047] The medical device 201 comprises the balloon catheter 230 and a guidewire 233. The medical device 201 further comprises a balloon hub 234 and hemostat valves 235, 238 and a flush syringe 236. As described more fully below, the hemostat valve 238 is a known device, and is used to insert the optical fiber and enable translation during balloon inflation.

[0048] An endoinflator 239 is used to inflate the balloon 232 once deployed, and may be used to inject a contrast agent useful in generation of the shock wave from the photochemical reaction noted above. Notably, the endoinflator 239 may be a known device such as Encore™ inflator from Boston Scientific Corporation or a pumping system that automatically maintains a set pressure (i.e. a simplified version of an intra-aortic balloon pump such as AC3 Optimus™ Intra- Aortic Balloon Pump from Teleflex), or some other known device used to inflate the balloon 232. More generally, the component used to inflate the balloon 232, and provide saline, or contrast agent, or both, may be referred to herein as a pressure source.

[0049] The medical device 201 further comprises a hemostat valve 231 used to translate an optical fiber 240 into the balloon once the balloon is deployed. This translation is carried out manually by a clinician. This translation was described above, and is described more fully below, and enables the locating of the distal end (not shown) of the optical fiber 240 in the deployed balloon proximate a lesion (e.g., a calcium deposit in a vessel). The medical device 201 also comprises a laser catheter proximal hub 237 and a laser catheter 242. The laser catheter proximal hub 237 is connected to the laser, which for example, may be disposed in the console 280. The balloon catheter 230 contains the optical fiber 240 with a thicker coating to protect it. [0050] The optical fiber 240 that is inserted into the balloon 232 may also comprise a thin coating around the optical fiber, having an illustrative thickness of approximately 10 pm.

[0051] The diameter of the optical fiber 240 plays a role in the effectiveness of the medical device 201. Specifically, there is a trade-off between the amount of energy that can be transferred over the optical fiber 240 and still being able to insert the optical fiber 240 via the inflation lumen 253. While a comparatively large diameter optical fiber transmits more light energy than a comparatively small diameter optical fiber, there is a limit to the magnitude of the diameter of the optical fiber 240 as too large of a diameter may not be practically inserted via the inflation lumen 253. Moreover, and as noted above, the laser energy from the distal end 252 is illustratively great than approximately 2.5 mJ. Applicants have discovered that optical fibers having a diameter of approximately 200 pm enable the transfer of sufficient laser energy while at the same time being comparatively easy to insert via the inflation lumen 253. Moreover, optical fibers having a diameter of approximately 300 pm enable the transfer of sufficient laser energy more easily, but a bit more difficult to insert through the inflation lumen 253. More generally, the diameter of the optical fiber in the range of 100 pm to approximately 400 pm is contemplated with the optics of the transmission between the laser source in the console 280 and the distal end 252 of the optical fiber also a consideration in ensuring the transfer of sufficient laser energy to impact the lesion with an optical fiber that is not too difficult to insert via the inflation lumen 253.

[0052] Fig. 2C is a conceptual view of a medical device 201 deployed for treatment of a patient in accordance with a representative embodiment. Various aspects and details of the medical devices described above in connection with the representative embodiments of Figs. 1-2B may be common to those of the presently described representative embodiment. These common aspects and details may not be repeated to avoid obscuring the presently described representative embodiments.

[0053] Medical device 201 is disposed in a vessel 251 as shown. As alluded to above, the vessel may be a blood vessel (i.e., an artery or vein) or other vessel in the body where lesions (e.g., calcite formations) may form. During a procedure, a clinician introduces the guidewire 233 via the guidewire lumen 224 through the balloon catheter 230, which is disposed over the guidewire 233. This balloon catheter 230 can be an over-the-wire or a rapid-exchange type. As shown, the guidewire 233 extends beyond the distal end of the balloon 232. The guidewire 233 illustratively extends past the distal end of the balloon catheter 230 as it is advanced first and acts as rail over which the catheter is advanced to the desired location. Typically, the guidewire 233 is then advanced beyond the lesion 229.

[0054] The balloon 232 is then deployed and inflated by the endoinflator 239 as alluded to above. In this sequence, fluid is introduced through the balloon 232 may be inflated with a fluid (e.g., saline), or a contrast agent, or both.

[0055] In accordance with a representative embodiment, the optical fiber 240 is introduced to the balloon 232 via an inflation lumen 253 using hemostat valve 238 or similar device. The hemostat valve 238 enables the translation of the optical fiber in a direction (e.g., parallel to the x-direction in the coordinate system of Fig. 2C) in the vessel 251 so that its distal end 252 in a location proximate to a lesion that is desirably broken up by the shock wave created by the photochemical reaction of the contrast agent.

[0056] As shown, the lesion 229 impedes the full inflation of the balloon 232, and as a result, the balloon 232 does not reach its fully-inflated shape.

[0057] As noted above, in accordance with various representative embodiments, when illuminated by laser light generated in the console 280 and emanating from the distal end 252 of the optical fiber 240, a photochemical reaction occurs in the contrast agent and causes sonic energy (e.g., a shock wave) to be created in the balloon 232. The distal end 252 of the optical fiber 240 is disposed in a location proximate to the lesion 229 that the resultant shockwave breaks up or disintegrates the lesion 229. As such, the calcium in the lesion 229 is cracked by the shock wave created in the photochemical reaction induced by the laser light’s interaction with the contrast agent.

[0058] As noted above, among other benefits, the medical device 201 is adapted to carry out to treat other lesions (not shown) that exist elsewhere in the vessel 251. Specifically, the locations of the lesions are identified using an imaging system (e.g., imaging device 205 and display 220) by the clinician and the distal end 252 of the optical fiber 240 is translated through the vessel 251 to a location proximate to the lesion. Illustrative, a marker 254 (e.g., a marker that is radiopaque in a fluoroscopic image) may be disposed near to or at the distal end 252 of the optical fiber 240 to aid the clinician in locating the distal end 252 of the optical fiber 240 for its proper placement proximate to a lesion to be broken up by the shock wave created in the photochemical reaction described above. In accordance with a representative embodiment, two or more markings on the outside optical fiber may be provided that indicate when distal end 252 of the optical fiber is entering the balloon 232 and when the distal end 252 is near the distal end of the balloon 232.

The markers may be placed such that when the most distal marking enters the hemostat valve the distal end 252 of the optical fiber 240 enters the balloon and when the most proximal marking enters the hemostat valve the distal end 252 of the optical fiber 240 is near the distal end of the balloon. Using the imaging device 205, the clinician has a visualization on the x-ray of the optical fiber 240 where the approximate location of the distal end 252 should be, and to aid in preventing the distal end 252 from contacting the distal end of the balloon 232.

[0059] An illustrative workflow for locating the distal end 252 of the optical fiber 240 comprises moving the balloon catheter 230 over the guidewire 233 to the desired location proximate a lesion in the vessel 251 under guidance of the imaging device 205. The balloon 232 is inflated to push the lesion 229 into the wall of the vessel 251. In the event the clinician determined the lesion 229 is not sufficiently pushed into the wall (by seeing on the display 220 that the balloon 232 is not able to fully expand at a location and thus is distorted as shown in Fig. 2C) the optical fiber 240 is inserted via the hemostat valve 238into the inflation lumen 253 towards the balloon 232. The balloon 232 is inflated and the distal end 252 of the optical fiber 240 is then moved to the location of the lesion. Once the distal end 252 is properly located, laser pulses are generated and emitted from the distal end of the optical fiber to initiate cracking the calcium via the shock waves. When the calcium is sufficiently cracked the balloon will be able to push the lesion to the side. Notably, the hardness of the lesion 229 determines the amount of laser energy and resultant shock waves are required to sufficiently break up the lesion 229 so it can be moved by the balloon 232. Just by way of example, the number of pulses provided from the laser (and thus the number of shock waves) may be as few as approximately 10, and may be as many as approximately 500.

[0060] Notably, based on images on the display 220, when another lesion that is also already covered by the balloon 232 (i.e., is distorting the balloon in its initial location), and the balloon 232 is also not able to push the lesion sufficiently to the wall of the vessel 251 , the optical fiber 240 may be moved within the balloon 232 proximate to the other lesion. The laser energy is then provided as described above to generate the shock wave(s) to break up the lesion. In the event another lesion is shown in images on the display, and is located in a portion of the vessel 251 that is not covered by the balloon (e.g., farther down the length of the vessel 251), the balloon is deflated and the balloon catheter 230 is then moved to that location. The optical fiber 240 remains in the balloon catheter 230 during this translation of the balloon catheter 230 (i.e., is not removed from the balloon catheter). Once the distal end 252 of the optical fiber 240 is located proximate to the lesion, laser energy is then provided as described above to generate the shock wave(s) to break up the lesion in the case that lesion can also not be pushed in to the wall with just inflating the balloon.

[0061] This procedure can be repeated for other lesions (not shown) in other locations in the vessel 251 without disrupting the work flow of the procedure. Moreover, as noted above, the balloon 232 is a “typical” or “regular” balloon, and is not a “specialty” balloon required by certain known devices. As such, once the optical fiber 240 is initially introduced into the balloon 232 via the inflation lumen 253, its distal end 252 can be readily moved with the balloon 232 to other locations where lesions are identified by the clinician. By contrast to a known device used to break up lesions that require the removal of a the “typical” balloon, the introduction of a “specialty” balloon to carry out the breaking up of the lesion, and the reintroduction of another “typical” to continue the procedure, in accordance with certain representative embodiments, the “typical” or “regular” balloon 232 is introduced and treatment of lesions can proceed without disrupting the work flow. This reduction in the labor required, as well as the dispensing with the need for a “specialty” balloon required by a known device to carry out the breaking up of the lesion, and the introduction of another “typical” balloon to continue the procedure, also results in a reduction in the cost of the procedure compared to the noted known device.

[0062] Fig. 2D is a close-up view of the portions of the medical device of Fig. 2C in accordance with a representative embodiment. Various aspects and details of the medical devices described above in connection with the representative embodiments of Figs. 1-2C may be common to those of the presently described representative embodiment. These common aspects and details may not be repeated to avoid obscuring the presently described representative embodiments.

[0063] During a procedure, a clinician introduces the guidewire 233 via the guidewire lumen 224 through the balloon catheter 230. As shown, the guidewire 233 extends beyond the distal end of the balloon 232.

[0064] The balloon 232 is then deployed and inflated by the endoinflator 239 as alluded to above. In this sequence, fluid is introduced through the balloon 232 may be inflated with a fluid (e.g., saline), or a contrast agent, or both.

[0065] In accordance with a representative embodiment, the optical fiber 240 is introduced to the balloon 232 via an inflation lumen 253 using hemostat valve 238 or similar device. The hemostat valve (not shown in Fig. 2D) enables the translation of the optical fiber in a direction (e.g., parallel to the x-direction in the coordinate system of Fig. 2C) of the vessel 251 so that its distal end 252 in a location proximate to a lesion that is desirably broken up by the shock wave created by the photochemical reaction of the contrast agent.

[0066] As shown, the lesion 229 impedes the full inflation of the balloon 232, and as a result, the balloon 232 does not reach its fully-inflated shape. [0067] As noted above, in accordance with various representative embodiments, when illuminated by laser light generated in the console 280 and emanating from the distal end 252 of the optical fiber 240, a photochemical reaction occurs in the contrast agent and causes sonic energy (e.g., a shock wave) to be created in the balloon 232. The distal end 252 of the optical fiber 240 is disposed in a location proximate to the lesion 229 that the resultant shockwave breaks up or disintegrates the lesion 229. As such, the calcium in the lesion 229 is cracked by the shock wave created in the photochemical reaction induced by the laser light’s interaction with the contrast agent.

[0068] As noted above, among other benefits, the medical device 201 is adapted to carry out the treatment of other lesions (not shown) that exist elsewhere in the vessel 251. Specifically, as described more fully below, the locations of the lesions are identified using an imaging system (e.g., imaging device 205 and display 220) by the clinician and the distal end 252 of the optical fiber 240 is translated through the vessel 251 to a location proximate to the lesion. Illustrative, a marker 254 (e.g., a marker that is radiopaque in a fluoroscopic image) may be disposed near to or at the distal end 252 of the optical fiber 240 to aid the clinician in locating the distal end 252 of the optical fiber 240 for its proper placement proximate to a lesion to be broken up/cracked by the shock wave created in the photochemical reaction described above. This procedure can be repeated for other lesions (not shown) in other locations in the vessel 251 without disrupting the work flow of the procedure. Moreover, as noted above, the balloon 232 is a “typical” or “regular” balloon, and is not a “specialty” balloon required by certain known devices. As such, once the optical fiber 240 is initially introduced into the balloon 232 via the inflation lumen 253, its distal end 252 can be readily moved with the balloon 232 to other locations where lesions are identified by the clinician. By contrast to a known device used to break up lesions that require the removal of a the “typical” balloon, the introduction of a “specialty” balloon to carry out the breaking up of the lesion, and the reintroduction of another “typical” to continue the procedure, in accordance with certain representative embodiments, the “typical” or “regular” balloon 232 is introduced and treatment of lesions can proceed without disrupting the work flow. This reduction in the labor required, as well as the dispensing with the need for a “specialty” balloon required by a known device to carry out the breaking up of the lesion, and the introduction of another “typical” balloon to continue the procedure, also results in a reduction in the cost of the procedure compared to the noted known device.

[0069] Fig. 2E is a close-up view of the portions of a medical device in accordance with a representative embodiment. Various aspects and details of the medical devices described above in connection with the representative embodiments of Figs. 1-2D may be common to those of the presently described representative embodiment. These common aspects and details may not be repeated to avoid obscuring the presently described representative embodiments.

[0070] During a procedure, a clinician introduces the guidewire (not shown in Fig. 2E) via the guidewire lumen 224 through the balloon catheter 230. As shown, the guidewire 233 extends beyond the distal end of the balloon 232.

[0071] The balloon 232 is then deployed and inflated by the endoinflator (not shown in Fig. 2E) as described above. In this sequence, fluid is introduced through the balloon 232 may be inflated with a fluid (e.g., saline), or a contrast agent, or both.

[0072] In accordance with a representative embodiment, the guidewire 233 is removed from the guidewire lumen 224, and the optical fiber 240 is introduced to the balloon 232. The hemostat valve (not shown in Fig. 2D) enables the translation of the optical fiber in a direction (e.g., parallel to the x-direction in the coordinate system of Fig. 2C) of the vessel 251 so that its distal end 252 in a location proximate to a lesion that is desirably broken up by the shock wave created by the photochemical reaction of the contrast agent. As such, in accordance with the presently described representative embodiment, the optical fiber 240 is not introduced via the inflation lumen 253, but rather via the guidewire lumen 224 after the guidewire is removed. To function as a guidewire the optical fiber can then also be incorporated into a guide wire form factor (i.e. with the appropriate shape, size and mechanics and coating).

[0073] As noted above, in accordance with various representative embodiments, when illuminated by laser light generated in the console (not shown in Fig. 2E) and emanating from the distal end 252 of the optical fiber 240, a photochemical reaction occurs in the contrast agent and causes sonic energy (e.g., a shock wave) to be created in the balloon 232. The distal end 252 of the optical fiber 240 is disposed in a location proximate to the lesion 229 that the resultant shockwave breaks up or disintegrates the lesion 229. As such, the calcium in lesion 229 is cracked by the shock wave created in the photochemical reaction induced by the laser light’s interaction with the contrast agent. The contrast agent is introduced in the guidewire lumen 244 via a syringe (e.g.., flush syringe 236 in Fig. 2B).

[0074] As noted above, among other benefits, the medical device 201 is adapted to carry out the cracking of other lesions (not shown) that exist elsewhere in the vessel 251. Specifically, the locations of the lesions are identified using an imaging system (e.g., imaging device 205 and display 220) by the clinician and the distal end 252 of the optical fiber 240 is translated through the vessel 251 to a location proximate to the lesion. Illustrative, a marker 254 (e.g., a marker that is radiopaque in a fluoroscopic image) may be disposed near to or at the distal end 252 of the optical fiber 240 to aid the clinician in locating the distal end 252 of the optical fiber 240 for its proper placement proximate to a lesion to be broken up/cracked by the shock wave created in the photochemical reaction described above. This procedure can be repeated for other lesions (not shown) in other locations in the vessel 251 without disrupting the work flow of the procedure. Moreover, as noted above, the balloon 232 is a “typical” or “regular” balloon, and is not a “specialty” balloon required by certain known devices. As such, once the optical fiber 240 is initially introduced into the balloon 232 via the inflation lumen 253, its distal end 252 can be readily moved with the balloon 232 to other locations where lesions are identified by the clinician. By contrast to a known device used to break up lesions that require the removal of a the “typical” balloon, the introduction of a “specialty” balloon to carry out the breaking up of the lesion, and the reintroduction of another “typical” to continue the procedure, in accordance with certain representative embodiments, the “typical” or “regular” balloon 232 is introduced and treatment of lesions can proceed without disrupting the work flow. This reduction in the labor required, as well as the dispensing with the need for a “specialty” balloon required by a known device to carry out the breaking up of the lesion, and the introduction of another “typical” balloon to continue the procedure, also results in a reduction in the cost of the procedure compared to the noted known device.

[0075] Fig. 3 is a partial cut-away of a medical device deployed in a scoring balloon in accordance with another representative embodiment. Various aspects and details of the medical devices described above in connection with the representative embodiments of Figs. 1-2E may be common to those of the presently described representative embodiment. These common aspects and details may not be repeated to avoid obscuring the presently described representative embodiments. [0076] As shown in Fig. 3, a balloon 332 is deployed in a vessel 351. The balloon 332 comprises a plurality of ribs 302 disposed on an outer surface of the balloon 332. As will be appreciated by one of ordinary skill in the art, the balloon 332 of the structure shown is a scoring or cutting balloon.

[0077] The balloon 332 is deployed with a guidewire 333 that extends through the balloon 332 via a balloon catheter 330. An optical fiber 340 is deployed in the balloon 332, and comprises a distal end 352 from which laser light emanates to cause the photochemical reaction and a resultant shock wave 304 that breaks up or disintegrates a lesion near the distal end 352. As described above, the optical fiber 340 is adapted to translate in a forward or rearward direction as with the balloon 332 as shown with arrow 306, so the distal end 352 of the optical fiber 340 can be moved to be sufficiently proximate to other lesions in the vessel 351. Once the distal end 352 is properly located relative to other lesions located using the imaging device used by the clinician, laser light is emitted from the distal end 353 of the optical fiber 340 to crack the lesion. The combination of the scoring/cutting elements on the balloon 332 with generated shockwave fosters and improved ability to crack the calcium in the lesion.

[0078] Fig. 4 is a method 400 of generating shock waves to crack calcification in a vessel in accordance with a representative embodiment. Various aspects and details of the medical devices described above in connection with the representative embodiments of Figs. 1-3 may be common to those of the presently described representative embodiment. These common aspects and details may not be repeated to avoid obscuring the presently described representative embodiments.

[0079] At 401, the method 400 begins with the insertion of a balloon catheter and the inflation of the balloon. As described above, the balloon is a “typical” or “regular” balloon and not a “specialty” balloon that must be deployed in certain known medical devices to break apart calcium deposits.

[0080] At 404, the method 400 continues with the identification of locations with lesions (e.g., calcium deposits) in the vessel. As described above, this identification procedure is done using the imaging device 205 to provide images of a portion of the anatomy and the components of the medical device according to various embodiments. As such, lesions can be identified readily upon deployment of the balloon, which is deformed by a lesion (e.g., lesion 229) once inflated. [0081] At 406, the method continues with the introduction of the optical fiber via the inflation lumen of the balloon catheter using a hemostat valve. Notably, and as described above, the medical devices of the present teachings offer flexibility in the deployment of the optical fiber used to provide laser energy to cause the photochemical reactions that create shock waves to break up lesions. Specifically, the optical fiber can be introduced via the inflation lumen when the balloon is deployed, or at a later time after locations of lesions are identified. Still alternatively, the optical fiber may be introduced via the guidewire lumen after the guidewire is removed, as described in connection with the representative embodiments of Fig. 2E.

[0082] At 408, the distal end of the optical fiber is moved (translated) in the vessel to be proximate to a lesion identified by the clinician using the imaging device.

[0083] At 410, laser light is provided (e.g., from a laser disposed in console 280) to the optical fiber and emanates from its distal end. This generates a shock wave that breaks up the lesion as described above. Notably, this light is continually applied (i.e., pulsed) until the balloon has expanded sufficiently. Stated somewhat differently, laser light is pulsed with each pulse generating a shock wave. These shock waves continually break the lesion until the balloon pressure is adapted to push the lesion outwards into the vessel wall, for example as shown in Figs. 2C-2E where the lesion 229 clearly deforms balloon 232.

[0084] At 412, the method 400 continues with moving/translating the optical fiber so its [0085] distal end is proximate another lesion identified and located by the clinician using the imaging device. During this step, the laser energy may continue to be provided to the optical fiber, or may be terminated until the balloon is properly located at the other lesion. The procedure then continues at 410 with providing laser light to the optical fiber in a continual manner until the lesion is broken up by the shock wave(s) sufficiently that the balloon again is expanded sufficiently. The cycle of 410, 412 may be repeated until the clinician decides to terminate the procedure (e.g., when lesions are sufficiently cracked), and at 414, the laser energy application via the optical fiber is terminated and the optical fiber is removed. At 416, the method 400 is completed with removal of the balloon catheter.

[0086] The illustrations of the embodiments described herein are intended to provide a general understanding of the structure of the various embodiments. The illustrations are not intended to serve as a complete description of all of the elements and features of the disclosure described herein. Many other embodiments may be apparent to those of skill in the art upon reviewing the disclosure. Other embodiments may be utilized and derived from the disclosure, such that structural and logical substitutions and changes may be made without departing from the scope of the disclosure. Additionally, the illustrations are merely representational and may not be drawn to scale. Certain proportions within the illustrations may be exaggerated, while other proportions may be minimized. Accordingly, the disclosure and the figures are to be regarded as illustrative rather than restrictive.

[0087] One or more embodiments of the disclosure may be referred to herein, individually and/or collectively, by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any particular invention or inventive concept. Moreover, although specific embodiments have been illustrated and described herein, it should be appreciated that any subsequent arrangement designed to achieve the same or similar purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all subsequent adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the description.

[0088] The Abstract of the Disclosure is provided to comply with 37 C.F.R. § 1.72(b) and is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, in the foregoing Detailed Description, various features may be grouped together or described in a single embodiment for the purpose of streamlining the disclosure. This disclosure is not to be interpreted as reflecting an intention that the claimed embodiments require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter may be directed to less than all of the features of any of the disclosed embodiments. Thus, the following claims are incorporated into the Detailed Description, with each claim standing on its own as defining separately claimed subject matter.

[0089] The preceding description of the disclosed embodiments is provided to enable any person skilled in the art to practice the concepts described in the present disclosure. As such, the above disclosed subject matter is to be considered illustrative, and not restrictive, and the appended claims are intended to cover all such modifications, enhancements, and other embodiments which fall within the true spirit and scope of the present disclosure. Thus, to the maximum extent allowed by law, the scope of the present disclosure is to be determined by the broadest permissible interpretation of the following claims and their equivalents and shall not be restricted or limited by the foregoing detailed description.

Claims

CLAIMS:

1. A medical device, comprising: an inflatable balloon adapted to be deployed in a balloon catheter, wherein the inflatable balloon is disposed along an axis and is adapted to receive a contrast agent therein; an inflation lumen adapted to inflate and deflate the balloon, wherein the inflation lumen is disposed in a direction substantially parallel to the axis; and an optical fiber disposed in the inflation lumen, the optical fiber having a distal end, wherein the optical fiber is adapted to translate along in the direction: wherein when light of a selected wavelength from a laser is emitted from the distal end of the optical fiber, a photochemical reaction occurs in the contrast agent and creates a shock wave adapted to break a lesion comprising calcium in a blood vessel.

2. The medical device of claim 1 , wherein the translation of the optical fiber causes the locating of the distal end of the optical fiber in a region where another lesion is located in the blood vessel.

3. The medical device of claim 1, further comprising a hemostat valve adapted to connect an endo-inflator so that the optical fiber can be disposed in the balloon after the balloon is inflated.

4. The medical device of claim 1 , wherein the optical fiber is adapted to be introduced into the balloon catheter at a time after the balloon is deployed.

5. The medical device of claim 1, wherein the balloon is a scoring or cutting balloon.

6. The medical device of claim 1 , wherein a sheath is disposed in the inflation lumen and the optical fiber is inserted into the inflation lumen via the sheath.

7. The medical device of claim 1, further comprising radiopaque markers disposed on the optical fiber, the radiopaque markers being adapted to locate the optical fiber inside the balloon.

8. The medical device of claim 1, further comprising markers disposed on the outside of the proximal side the optical fiber so that a location of the distal end of the optical fiber can be determined visually without the use of an imaging device.

9. A medical device, comprising: an inflatable balloon adapted to be deployed in a balloon catheter, wherein the inflatable balloon is disposed along an axis and is adapted to receive a contrast agent therein; an inflation lumen adapted to inflate and deflate the balloon, wherein the inflation lumen is disposed in a direction substantially parallel to the axis, wherein the contrast agent is provided through the guidewire lumen; and an optical fiber disposed in a guidewire lumen, the optical fiber having a distal end, the optical fiber being adapted to translate along in the direction, wherein when light of a selected wavelength from a laser is emitted from the distal end of the optical fiber, a photochemical reaction occurs in the contrast agent and creates a shock wave adapted to break a lesion comprising calcium in a blood vessel.

10. The medical device of claim 9, wherein the translation of the optical fiber varies to locate the distal end of the optical fiber in a region where another lesion is located in the blood vessel.

11. The medical device of claim 9, wherein the optical fiber is adapted to be introduced into the balloon catheter at a time after the balloon is deployed.

12. The medical device of claim 9, wherein the balloon is a scoring or cutting balloon.

13. A medical system, comprising: a console; an imaging device comprising a display; a pressure source; and a medical device comprising: an inflatable balloon adapted to be deployed in a balloon catheter, wherein the inflatable balloon is disposed along an axis and is adapted to receive a contrast agent therein; an inflation lumen and adapted to provide or remove saline and/or the contrast agent to inflate or deflate the balloon, the inflation lumen being disposed in a direction substantially parallel to the axis; and an optical fiber disposed on the inflation lumen, the optical fiber having a distal end, wherein the optical fiber is adapted to translate along in the direction wherein when light of a selected wavelength from a laser is emitted from the distal end of the optical fiber, a photochemical reaction occurs in the contrast agent and creates a shock wave adapted to break a lesion comprising calcium in a blood vessel.

14. The medical system of claim 13, wherein the imaging device is adapted to show the location of the distal end of the optical fiber.

15. The medical system of claim 14, wherein the translation of the optical fiber is shown on the imaging device, and the translation varies to locate the distal end of the optical fiber in a region where another lesion is located in the blood vessel.

16. The medical system of claim 14, wherein the imaging device comprises a fluoroscope or an ultrasound imaging device.