Intravascular lithotripsy system

Abstract

An endovascular lithotripsy system having an angioplasty-like balloon capable of being filled with a fluid, such as including brine, which may be mixed with or otherwise provided with known other fluid components, such as contrast agents. The system may include at least one emitter or electrode pair for generating therapy. For example, energy waves or high-pressure acoustic energy waves within a balloon having a fluid inside may provide treatment. The system also includes a sensor for detecting damage to the balloon, such as a rupture. The system also includes a control module having a processor for receiving information about balloon injury or rupture and the ability of the system to prevent energy supply to the emitter or electrode upon detection of balloon injury or unacceptable degradation or impending predicted failure.

Description

[0001] Cross-references to related applications

[0002] This application claims priority and benefit to U.S. Provisional Patent Application No. 63 / 460,344, filed April 19, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] Catheters and systems used in endovascular medical procedures to treat conditions such as calcified lesions. Background Technology

[0004] Vascular calcification obstructs normal blood flow and is associated with adverse health consequences, including severe blood flow restriction. Calcification can range from mild to severe, and its patterns can vary significantly.

[0005] Intravascular lithotripsy (IVL) is a medical procedure that uses shock waves or high-energy sound waves to break up calcified plaques inside blood vessels. This procedure is commonly used to treat conditions such as peripheral artery disease, which can lead to poor circulation and increase the risk of heart attack or stroke. IVL is also used for cardiac applications. However, traditional IVL systems have some limitations, including the risk of damaging the balloon used in conjunction with shock waves. In some cases, the balloon may rupture, leading to complications for the patient.

[0006] One successful approach to mitigating the adverse effects of calcification is orbital atherectomy. While highly successful and considered the gold standard for treating challenging calcifications, physicians can choose other less challenging modalities.

[0007] Intravascular lithotripsy (IVL) devices can be used for several calcification patterns. Disposable IVL balloon devices are available in different designs and sizes for peripheral or coronary indications. Commercially available designs utilize reusable power sources, such as IVL generators. A reusable generator includes the following specifications:

[0008]

[0009] The generator is used in conjunction with a disposable catheter. One such disposable device consists of a 0.014-inch guidewire-compatible, fluid-filled angioplasty-like balloon catheter, with two lithotripsy emitters integrated into the axis of a 12 mm long balloon segment. The fluid-filled angioplasty-like balloon (e.g., 50 / 50 saline contrast agent) is inflated to approximately 4 atmospheres, and then an electrical pulse is supplied to the emitter, which generates a high-voltage spark to deliver the treatment. Sound waves are generated, and then the calcium breaks. Figure 6 The report details a known IVL balloon.

[0010] An example of existing IVL treatment includes this treatment sequence:

[0011]

[0012] Balloon lifespan is a known issue associated with currently available IVL devices. The maximum pulse count is design-specific, with one device limiting pulses to 300 pulses and another limiting it to 160 pulses per balloon. IVL generators are designed to automatically stop if a user attempts to deliver more than the maximum allowed number of consecutive pulses. To resume pulses, the user must wait at least a minimum pause before resuming treatment. Treatment must be resumed by releasing and pressing the treatment button again. After multiple pulses well below the limit, harmful substances may be found inside the saline-filled balloon due to the electrical pulses and the energy generated (bubble generation, collapse, heat, shock waves).

[0013] If the balloon ruptures or otherwise fails during the treatment pulse, the IVL device of the currently available system is under the control of a human operator to identify the balloon failure and stop treatment. If the current system experiences a failure at the start of the pulse cycle, the system will continue to deliver the treatment course unless the failure is identified and intervened by a human.

[0014] An example of a balloon integrity monitoring system is disclosed in U.S. Patent Application Publication No. 20210378743, published on December 9, 2021. However, this system is complex and includes designs that can negatively impact the system's cross-profile, as well as its stiffness and cost. Summary of the Invention

[0015] This invention relates to an intravascular lithotripsy system having an angioplasty-like balloon capable of being filled with a fluid, such as saline. It is known to provide and use saline as the inflation fluid, thus saline can be a component of the fluid. It is also known to mix or provide other fluids, such as contrast agents, with or with the saline. The system may include at least one transmitter or electrode pair for generating treatment. For example, energy waves or high-pressure acoustic waves within the balloon containing fluid can provide treatment. The system also includes sensors for detecting damage to the balloon, such as rupture. The system further includes a control module with a processor for receiving information about balloon damage or rupture, and the ability to prevent the system from supplying energy to the transmitter or electrodes once balloon damage, unacceptable degradation, or impending predicted failure is detected.

[0016] In another embodiment, the intravascular lithotripsy system described herein includes an angioplasty-like balloon capable of being filled with fluid, at least one transmitter or electrode pair for generating energy waves or high-pressure acoustic waves within the balloon, a sensor located in the proximal region of the catheter assembly for detecting damage or other failures or impending failures of the balloon, and a control module having a microprocessor for receiving information about balloon damage, rupture, or failure and preventing the system from supplying energy to the transmitter or electrodes. The system may optionally help physicians avoid unintended balloon rupture by automatically communicating the potential impending failure of the balloon.

[0017] In one aspect of the invention, an intravascular lithotripsy (IVL) system includes a catheter, sensors, and a control system. The catheter has a distal end with an inflatable balloon and at least one transmitter disposed therefrom. The at least one transmitter is used to generate an energy wave within the balloon to perform IVL operations and to treat lesions in the subject's vascular system. The sensors are operatively associated with the balloon for monitoring the balloon's condition and for detecting unwanted levels of damage to the balloon. The control system is operatively connected to the sensors and transmitter for preventing the transmitter from generating further energy waves and further IVL operations when the sensors determine unwanted levels of damage to the balloon.

[0018] The sensor may include a pressure sensor that monitors the fluid pressure within either the balloon or the pressure fluid lumen of the catheter, which supplies inflation fluid to the balloon to directly or indirectly monitor the fluid pressure within the balloon. The pressure sensor may be positioned on the catheter shaft portion of the IVL system within the balloon for direct monitoring of the fluid pressure within the balloon. Alternatively, the pressure sensor may be positioned on a portion of the catheter located outside the subject's vascular system and indirectly connected to the balloon via the pressure fluid lumen of the catheter for balloon inflation.

[0019] The system may also include a high-voltage pulse generator electrically connected to the transmitter and used to generate a spark at the transmitter inside the balloon when a high-voltage pulse is generated by the treatment initiation control module.

[0020] The system may further include an indicator feature that, upon detection of unwanted damage to the balloon, provides the user with information about at least the unwanted damage to the balloon.

[0021] The system may include multiple sensors for monitoring the balloon and determining unwanted levels of damage to it. A control module including a processor and memory may also be provided, the memory containing programming for controlling the failure detection algorithm.

[0022] At least one sensor may alternatively include an optical sensor that senses harmful materials within the inflation fluid, the presence of which is associated with impending balloon failure. At least one sensor may also include a MEMS pressure sensor.

[0023] In another aspect of the invention, a method of using an intravascular lithotripsy (IVL) system with a firing-stop feature may include: inserting an angioplasty-like balloon into the region of an intravascular lesion in a subject's vascular system; at least partially inflating the balloon; firing the IVL system to generate an energy wave within the angioplasty-like balloon to deliver treatment to the lesion; monitoring the condition of the angioplasty balloon; detecting an unwanted level of damage to the balloon; and subsequently stopping the firing of the system after an unwanted level of damage to the balloon has been detected.

[0024] The method may also include steps of providing the user with a signal indicating that the IVL system is preventing further treatment using the IVL system and generating energy waves within the balloon.

[0025] The inventions disclosed in this article specifically address these problems. Attached Figure Description

[0026] These accompanying drawings are exemplary illustrations of certain embodiments and are therefore not intended to limit this disclosure.

[0027] Figure 1 A system including a sensor according to the present invention is illustrated schematically.

[0028] Figure 2 An inflatable balloon with sensors in a blood vessel for providing intravascular lithotripsy is schematically shown according to one aspect of the invention.

[0029] Figure 3 This is a schematic flowchart illustrating a method according to another aspect of the present invention.

[0030] Figure 4 This is a schematic cross-section of a conduit connector according to an embodiment of the present invention.

[0031] Figure 5 This is a schematic diagram of another embodiment of the present invention, which illustrates a system having multiple wave-generating electrode pairs.

[0032] Figure 6 This is an illustration of the characteristics of certain IVL catheters, showing the working length of such IVL catheters, the energy profile of IVL catheters, and details of providing an optimized overlap area within such IVL catheter designs. Detailed Implementation

[0033] Unless the context otherwise requires, the following terms or phrases shall have the following meanings (singular and plural forms):

[0034] The terms "conductor," "conductive," and "conductive" refer to materials that can easily allow electric current to flow through them. In some examples, conductive materials can be thermally conductive, but this is not always the case. Materials such as carbon black, gold, and metals are representative examples of conductive materials.

[0035] The phrase "conductive path" refers to a feasible path along which an electric current flows, and can refer, for example, to the entire surface of a balloon coated with a conductive material on its components, or only a portion of the surface or layer of the balloon coated with a conductive material such as a conductive strip or a predetermined (e.g., rectangular) shape. Examples of ink-printed medical devices are described in U.S. Patent Nos. 5,836,874, 7,379,767, 9,763,624, 9,913,594, and 10,751,000.

[0036] The phrase "intravascular lithotripsy device" includes a device that generates sound waves through a spark or arc discharge between electrode components, but may also include a device that generates acoustic energy within a balloon using a laser energy source. Examples of such laser systems are described in U.S. Patent Nos. 11,058,492 and 11,246,569 (the entire contents of which are incorporated herein by reference). Examples of inductive systems are described in U.S. Patent Nos. 8,728,091, 9,642,673, and 10,850,07, and published U.S. Patent Application No. 2022-0054194 (the entire contents of which are incorporated herein by reference). Any suitable energy source can be used to generate shock waves or sound waves. Examples include laser-based systems, spark-generating systems, ultrasound systems, high-intensity focused ultrasound (HIFU) systems, etc.

[0037] The phrase “lithograph emitter” refers to an electrode-based system and may also include laser or optical systems.

[0038] The phrase "angioplasty balloon material" refers to any material previously used for angioplasty balloons, including compliant, semi-compliant, and non-compliant balloons. Such materials include materials with composite or multilayer structures. Compliant materials include silicone, polyurethane, or nitinol. In some embodiments, the angioplasty balloon material may include a balloon-within-a-balloon design, and the fluid filling the inner balloon may differ from the fluid filling the outer balloon to take advantage of differences in the insulating properties and sound velocity of the materials. Compliant, semi-compliant, and non-compliant materials may include nylon, polyurethane, silicone, polyethylene terephthalate (PET), and other biocompatible materials. Recommended burst pressures for angioplasty balloons are typically between 4 atmospheres and 20 atmospheres, more preferably between 8 atmospheres and 12 atmospheres, and one example is nylon 12 material having a rated burst pressure between approximately 9 atmospheres and 12 atmospheres.

[0039] Refer to the attached diagram. Figure 1 A system 10 according to the invention is shown, comprising a power source 12 (in the form of a generator, but alternatively in the form of a laser or ultrasound system), an optional handle H, a treatment delivery controller 15, and a guidewire G-type catheter 20 (e.g., a disposable guidewire G-type catheter 20) having two lithotripsy emitters 22 (shown in the form of arc electrodes, but alternatively, they may comprise optical or laser emitters or ultrasound emitters), and a fluid-fillable balloon 24. The housing of the power source 12 may also house a control module with a microprocessor, as described in more detail below. An optional imaging marker band B may be provided. The system also includes a sensor S for detecting balloon 24 failure. In this embodiment, the sensor is shown mounted on the axis of a catheter assembly that includes a passage or lumen for the guidewire G.

[0040] The transmitter or electrode 22 is capable of generating shock waves or high-energy sound waves within the balloon 24. The transmitter or electrode can be positioned within the balloon along an axial member used to hold the energy delivery component. They can be positioned linearly along the longitudinal axis of the system or at different radial angles to provide more effective 360-degree treatment. In another embodiment, the shock wave can be generated externally, and the balloon may include energy deflection or focusing elements for receiving energy and directing it toward the lesion.

[0041] The balloon 24 can be positioned in a retracted position for easier access to the calcified site via the patient's vascular system. When used in vivo, the balloon 24 is advanced to the treatment site and then inflated to a pressure commonly used for angioplasty procedures (e.g., 4 atmospheres), and treatment is actuated by user activation (e.g., pressing a button) of the delivery controller 15. Several treatment sessions (e.g., 8 or more) are typically performed before exceeding the maximum permissible number of treatment sessions.

[0042] Figure 2 A balloon 24 inflated to a treatment delivery state is shown, wherein a lithotripsy launcher 24 can be “fired” to destroy calcium C. An optional marker band B may be provided to provide visualization and proper positioning using known imaging techniques. The balloon 24 is inflated to a typical angioplasty pressure (e.g., 4 atmospheres) and the treatment is delivered. The balloon 24 may spontaneously expand due to its internal pressure during or after treatment delivery (as the calcium blockage is broken or ruptured) to clear the blood vessel for blood flow.

[0043] The material of the balloon 24 is inflated at a pressure far below its burst pressure (e.g., 10 atmospheres) to prevent balloon failure. The system also includes a sensor S for detecting damage to the balloon, such as rupture. In different embodiments, the location of the sensor S can vary. It can be located as follows: Figure 1 The sensor S can be located on the catheter axis shown, or it can be on the balloon material itself. For example, the conductive path to the sensor mounted on the balloon can be provided by ink-printed circuit components. Alternatively, the sensor S can be located near the proximal portion of the disposable catheter 20, as described below. Figure 5 The subject of discussion.

[0044] Sensor S should be located in a position where it will not be excessively interfered with by the treatment energy program. A shield or baffle can be used to protect some of the pressure sensors located in balloon 24 from the treatment energy, which could otherwise damage the sensors.

[0045] The sensor S can be a pressure sensor that detects a sudden drop in pressure or a decrease in balloon pressure below a predetermined level. Other types of sensors, such as strain gauges or temperature sensors, can also be used.

[0046] The pressure sensor can optionally be correlated with the pressure measured by the expansion of the flexible tube into the pressure sensor. Mounting the pressure sensor on the flexible tube section and / or on a flexible diaphragm mounted on the tube section allows for both indirect and direct measurement of viscous substances (contrast agent / saline mixture) within the lumen, relative to direct immersion in the liquid. This tube expansion for the pressure sensor will not allow direct fluid transfer and / or contact between the sensor and the fluid medium within the sensor, nor will it allow for electrical signals within the electrically connected balloon. This type of measurement can be seen in diaphragm sensors:

[0047]

[0048] Some contrast agent media resemble sugar water and can contaminate pressure sensors. This tubular expansion of the pressure sensor will prevent direct fluid transfer and / or contact between the sensor and the fluid medium within the sensor, as well as the electrical signal within the electrically connected balloon. The pressure signal within the lumen can be monitored to detect unacceptable or predictably poor attenuation rates, which indicate loss of binding or balloon perforation / rupture.

[0049] The pressure within the balloon can also be monitored to measure the fluid volume in the system. When the IVL system is activated and the balloon inflates, the volume in the system increases as the pressure decreases. By observing changes in the pressure curve, it is possible to distinguish between sustained decay / rupture and pressure increases / decreases caused by changes in balloon volume.

[0050] Pressure sensors can detect failures in angioplasty-like balloon systems, for example, by:

[0051] Overinflation: One of the most common failures of angioplasty balloons is overinflation, which can cause the balloon to rupture. Pressure sensors placed inside the balloon can directly detect the pressure within the balloon and alert the medical team if the pressure exceeds a predetermined level. This helps prevent balloon rupture and harm to the patient.

[0052] Leakage: Another potential failure mode of angioplasty balloons is leakage, which can occur if the balloon material is defective or the balloon is not properly inflated. Pressure sensors can detect the rate of pressure drop or a decrease in intraballoon pressure to a threshold, indicating a leak, and alert the medical team. This helps ensure the balloon is replaced before the procedure continues, reducing the risk of complications.

[0053] Overall, pressure sensors can play a role in ensuring the safety and effectiveness of lithotripsy procedures by detecting potential failures in the balloon and alerting the medical team to take appropriate action.

[0054] Sensor S is preferably connected to a microprocessor that receives information about balloon damage or rupture. System 10 may include a control module that may include a hardware microprocessor and memory operatively connected together. The memory includes programming, which may include software or firmware for controlling any number of failure detection algorithms or tests, such as those described herein, when executed by the processor. Processor P may be programmed to prevent system 10 from supplying energy to the transmitter or electrodes if there is a risk of further damage to the balloon, balloon failure, or impending balloon failure. For example, if sensor S detects a sudden pressure drop, the microprocessor may automatically stop the delivery of shock waves or high-energy sound waves to prevent further damage to the balloon and any undesirable consequences for the patient. In addition to rapid drops, pressure in the system (catheter and balloon) may be monitored to detect high-pressure spikes indicating kinks or occlusion, or to preemptively indicate a possible balloon leak and reduce pressure. The processor may be located partially or entirely in the power control console, or alternatively, the handle H or alternatively partially may be located in the catheter itself for possible response time advantages.

[0055] Alternatively, the microprocessor can be programmed to temporarily shut down the pressure monitoring system during the very short duration of the therapeutic energy pulse. This strategy can be used to help filter out interference from the system.

[0056] The position of sensor S may vary. (Reference) Figure 5 The system 10' is shown, which has multiple (5) transmitters 22', a slightly different guidewire G system, a balloon 24', and sensors S near the proximal and distal portions of the catheter. Figure 4 A cross-section of a catheter connector is shown, illustrating one embodiment of the transmitter and guidewire for a pressure sensor, as well as the location of fluid for a balloon. Such a guidewire includes a portion of a conductive path for transferring energy to the transmitter.

[0057] Figure 5 An optional or alternative sensor S'' in the proximal portion of the catheter assembly in the form of a pressure sensor is also shown.

[0058] In one embodiment, the pressure sensor is located in the hub of the catheter assembly 20' (outside the body). Assuming the balloon can be semi-rigid / rigid and the fluid is incompressible (excluding air), the pressure outside the body will be the same as the pressure inside the body. This location has the advantage of allowing the pressure sensor to be reused. It also allows the sensor S to be relatively unaffected by electrical signals and high-energy pulses that may occur during treatment activation.

[0059] The sensor may include MEMS or optical thin-film fibers, such as a handle pressure sensor for monitoring the PVAD pressure lumen. This embodiment of the pressure sensing element S will operate in series with the device's pressure inflation lumen, utilizing a commercially available inflation device. The inflation of the balloon and adjustments to the inflation can still be controlled and managed using a commercially available inflation device.

[0060] In another embodiment, sensor S may include an optical sensor for detecting the presence of corrosive material and other harmful substances from the electrodes, the presence of which may be associated with impending balloon failure.

[0061] It should be noted that the processor or microprocessor can be programmed to identify balloon failure or impending balloon failure by processing information from various sources. For example, the system can count the number of treatment pulses delivered to a particular balloon; it can also have optical detectors for detecting electrode wear and the presence of harmful substances within the balloon, and the system's processor can also receive information from a pressure sensor S. If the device approaches (but does not exceed) the maximum number of pulses per balloon, but also detects harmful substances within the balloon and a drop in balloon pressure, the system can automatically shut down, albeit below the treatment limit, as an additional protection beyond simple pulse counting.

[0062] Commercially available IVL devices operate at voltages slightly below 3000 volts and include currents between 20 and 300 amps. This invention allows for the use of higher voltages and / or currents or power while ensuring patient safety. The control module can provide higher-energy treatment signals and correspondingly reduce the balloon's lifespan. This invention also reduces physician fatigue by providing less distraction during the procedure.

[0063] Now for reference Figure 3 In another aspect of the invention, the invention includes a method of using an endovascular system with therapeutic delivery and preventative features, the method comprising: inserting an angioplasty-like balloon into the lesion region of the endovascular space; at least partially inflating the balloon 24 (e.g., see...). Figure 2 In step 101, treatment is provided to the system to generate a shock wave or high-energy sound wave within the angioplasty-like balloon to treat the lesion; in step 103, the status of the angioplasty-like balloon is monitored; in step 105, an unwanted level of damage to the balloon is detected; and in step 107, firing of the system is prevented after an unwanted level of damage to the balloon is detected. Optionally, the system may notify the user of an interruption in treatment energy availability in step 109. If no balloon failure is detected, the system 10 may continue to enable treatment energy delivery in step 111.

[0064] The intravascular lithotripsy system and method described in this article can help physicians avoid unwanted balloon rupture by automatically communicating potential balloon failure. This feature can provide an increased level of safety for patients undergoing intravascular lithotripsy.

[0065] The apparatus shown in the accompanying drawings illustrates an exemplary system using the present invention. Note that the present invention can also be used with the systems described in the following patent applications (the entire contents of which are incorporated herein by reference):

[0066] 1. U.S. Provisional Patent Application No. 63 / 434,912; INTRAVASCULAR LITHOTRIPSY DEVICES AND SYSTEMS HAVING SPARK MONITORING FEEDBACK; Application Date: December 22, 2022; or

[0067] 2. U.S. Provisional Patent Application No. 63 / 425,169; Intravascular Lithotripsy Devices and Systems, Application Date: November 14, 2022

[0068] 3. U.S. Provisional Patent Application No. 63 / 416,231; CATHER SYSTEM WITH FORWARD FACINGELECTRODES FOR CREATING ENERGY WAVES; Application Date: October 14, 2022.

[0069] 4. U.S. Provisional Patent Application No. 63 / 458,728; INTRAVASCULAR LITHOTRIPSY DEVICES AND SYSTEMS WITH ENERGY WAVE DETECTION; Application Date: April 12, 2023.

[0070] The present invention is also particularly applicable to forward firing (e.g., axial) systems as described in the aforementioned patent application.

[0071] It should be understood that, based on the examples, certain actions or events in any method described herein may be performed in a different order, and may be added, combined, or omitted entirely (e.g., not all described behaviors or events are necessary to practice the method). Furthermore, in some examples, actions or events may be performed, for example, through multithreaded processing, interrupt handling, or simultaneous execution by multiple processors, rather than sequentially. Moreover, although some aspects of this disclosure are described for clarity as being performed by a single circuit or unit, it should be understood that the techniques of this disclosure can be performed by a combination of units or circuits associated with, for example, a medical device.

[0072] In one or more examples, the described functionality can be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functionality can be stored as one or more instructions or codes on a computer-readable medium and executed by a hardware-based processing unit. A computer-readable medium can include a computer-readable storage medium, which corresponds to a tangible medium such as a data storage medium (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store the required program code in the form of instructions or data structures and can be accessed by a computer).

[0073] Therefore, instructions can be executed by one or more processors, such as one or more digital signal processors (DSPs), general-purpose microprocessors, application-specific integrated circuits (ASICs), field-programmable arrays (FPGAs), or other equivalent integrated or discrete logic circuits. Thus, the terms "microprocessor" or "processor" as used herein can refer to any of the foregoing structures or any other structure suitable for implementing the techniques described herein. Furthermore, the techniques can be implemented entirely within one or more circuit or logic elements.

[0074] Therefore, specific examples of medical devices or systems have been presented in the foregoing description. It should be understood that the various aspects disclosed herein can be combined in combinations different from the specific combinations presented in the accompanying drawings. It should be understood that various modifications can be made to the cited examples without departing from the scope of this disclosure and the appended claims.

[0075] The description of the invention and its applications set forth herein is illustrative and not intended to limit the scope of the invention. Features of the various embodiments may be combined with other embodiments contemplated by the invention. Variations and modifications to the embodiments disclosed herein are possible, and practical substitutions and equivalents of various elements of the embodiments will be understood by those skilled in the art upon studying this patent document. These and other variations and modifications may be made to the embodiments disclosed herein without departing from the scope and spirit of the invention.

Claims

1. An intravascular lithotripsy (IVL) system comprising a catheter having a distal end, the distal end provided with an inflatable balloon and at least one emitter for generating energy waves within the balloon for performing IVL operations and providing treatment to a lesion of a subject's vasculature, a sensor operatively associated with the balloon for monitoring a condition of the balloon and for detecting an undesired level of damage to the balloon, a control system operatively connected with the sensor and the emitter for preventing the emitter from generating further energy waves and further IVL operations when the sensor determines an undesired level of damage to the balloon.

2. The system of claim 1, wherein, the sensor comprises a pressure sensor that monitors fluid pressure within one of the balloon or a pressure fluid lumen of the catheter that provides inflation fluid to the balloon to directly or indirectly monitor fluid pressure within the balloon.

3. The system of any of the preceding claims, wherein, the pressure sensor is disposed to a catheter shaft portion of the IVL system within the balloon for directly monitoring fluid pressure within the balloon.

4. The system of any of the preceding claims, wherein, the pressure sensor is disposed at a component of the catheter to be positioned outside of the subject's vasculature and is indirectly connected with the balloon by way of the pressure fluid lumen of the catheter for inflation of the balloon.

5. The system of any of the preceding claims, further comprising a high voltage pulse generator electrically connected with the emitter and for generating a spark at the emitter within the balloon when a high voltage pulse is generated by a treatment initiation control module.

6. The system of any of the preceding claims, further comprising an indication feature that provides information to a user of at least the undesired level of damage to the balloon when detected.

7. The system of any of the preceding claims, comprising a plurality of sensors for monitoring the balloon and for determining the undesired level of damage to the balloon.

8. The system of claim 1, wherein, the control module comprises a processor and a memory including programming for controlling a failure detection algorithm.

9. The system of any of the preceding claims, wherein, the sensor comprises an optical sensor that senses deleterious material within the inflation fluid, the presence of such deleterious material being correlated with an impending balloon failure.

10. The system of any of the preceding claims, wherein, the sensor comprises a MEMS pressure sensor.

11. A method of using an intravascular lithotripsy (IVL) system having a fire block feature, the method comprising: inserting an angioplasty-like balloon within a vessel of a subject's vasculature at a region of a lesion; at least partially expanding the balloon; firing the IVL system to generate energy waves within the angioplasty-like balloon to provide treatment to the lesion; monitoring a condition of the angioplasty balloon; detecting an undesired level of damage to the balloon; and thereafter preventing firing of the system after detecting the undesired level of damage to the balloon.

12. The method of claim 11, further comprising providing a user with a sign indicating that the IVL system is preventing further treatment using the IVL system and generating energy waves within the balloon.

13. The method of any one of claims 11-12, wherein, the sensor comprises a pressure sensor that monitors fluid pressure within one of the balloon or a pressure fluid lumen of the catheter, the pressure fluid lumen providing inflation fluid to the balloon to directly or indirectly monitor fluid pressure within the balloon.

14. The method of any one of claims 11 to 13, wherein, the pressure sensor is disposed to a catheter shaft portion of the IVL system within the balloon for direct monitoring of fluid pressure within the balloon.

15. The method of any one of claims 11 to 14, wherein, the pressure sensor is disposed at a component of the catheter to be positioned outside the subject's vasculature and is indirectly connected to the balloon by way of the pressure fluid lumen of the catheter for inflation of the balloon.

16. The method of any one of claims 11 to 15, further comprising a high voltage pulse generator in electrical connection with the emitter and for generating a spark at the emitter within the balloon when a high voltage pulse is generated by a treatment initiation control module.

17. The method of any one of claims 11 to 16, comprising a plurality of sensors for monitoring the balloon and for determining the undesired level of damage to the balloon.

18. The method of any one of claims 11 to 17, wherein, the control module comprises a processor and a memory, the memory comprising programming for controlling a failure detection algorithm.

19. The method of any one of claims 11 to 18, wherein, the sensor comprises an optical sensor that senses deleterious substances within the inflation fluid, the presence of such deleterious substances being correlated with an impending balloon failure.

20. The method of any one of claims 11 to 19, wherein, the sensor comprises a MEMS pressure sensor.

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