Endovascular lithotripsy system

Abstract

An endovascular lithotripsy system having a balloon, such as one used for angioplasty, which can be filled with a fluid, such as saline, which may be mixed with other fluid components, such as known contrast agents, or provided in other ways. The system may include at least one emitter or a pair of electrodes for generating treatment. For example, an energy wave or high-pressure acoustic energy wave in a balloon having fluid inside may provide treatment. The system also includes a sensor for detecting damage to the balloon, such as rupture. The system further includes a processor for receiving information on balloon damage or rupture, and a control module having the ability to prevent the system from energizing the emitter or electrodes when balloon damage or unacceptable degradation or anticipated imminent failure is detected.

Description

Technical Field

[0001] Cross - reference to related applications This application claims priority and benefit to U.S. Provisional Patent Application No. 63 / 460,344, filed on April 19, 2023.

[0002] A catheter and system for use in intravascular medical procedures for treating lesions such as calcified lesions.

Background Art

[0003] Vascular calcification impedes proper blood flow and is associated with adverse health effects, including severe blood flow restriction. Calcification can range from mild to severe, and the patterns of calcification can also vary widely.

[0004] Intravascular lithotripsy is a medical procedure that uses shock waves or high - energy acoustic waves to break up calcified plaques within blood vessels. This procedure is commonly used to treat conditions such as peripheral artery disease that can lead to poor blood circulation and an increased risk of heart attack or stroke. Intravascular lithotripsy is also used in heart - related applications. However, conventional intravascular lithotripsy systems have several limitations, including the risk of damage to the balloon used in conjunction with the shock waves. In some cases, the balloon can rupture, leading to patient complications.

[0005] One technique with a high success rate in reducing the adverse effects of calcification is orbital atherectomy. This treatment has a high success rate and is considered an absolute standard for treating difficult calcification problems. However, for less difficult calcification patterns, other options are also available to physicians.

[0006] Intravascular lithotripsy (IVL) devices are available for several calcification patterns. Disposable IVL balloon devices are available in various designs and dimensions to suit peripheral or coronary artery applications. Commercial designs utilize reusable power sources such as IVL generators. Some reusable generators include the following specifications:

[0007] [Table 1]

[0008] The generator is used in conjunction with a disposable catheter. One such disposable device consists of a fluid-filled angioplasty-like balloon catheter that fits a 0.014-inch guidewire, with two lithotripsy emitters incorporated into the shaft of a 12 mm long balloon segment. To deliver the treatment, the fluid-filled angioplasty-like balloon (e.g., 50 / 50 saline contrast agent) is inflated to approximately 4 atm, and then an electrical pulse is supplied to the emitter, which generates a high-voltage spark. An acoustic wave is generated, and calcium is fragmented. Reported details regarding known IVL balloons are shown in Figure 6.

[0009] An example of an existing IVL treatment includes this treatment sequence. Treatment frequency: 1 pulse per second Maximum number of continuous pulses (1 cycle): 20 pulses Minimum pause time: 10 seconds Maximum total pulse count per catheter: 160 (8 cycles)

[0010] Balloon lifespan is a known issue associated with currently available IVL devices. The maximum number of pulses is associated with specific designs; some devices limit the number of pulses to 300, while others limit it to 160 pulses per balloon. The IVL generator is designed to automatically stop if the user attempts to deliver more pulses than the maximum allowable continuous number of pulses. To resume pulse generation, the user must wait at least a minimum pause time before resuming treatment. To resume treatment, the treatment button must be released and then pressed again. After a number of pulses far below the limit, harmful substances may be found inside a saline-filled balloon, caused by the electrical pulses and the energy generated (bubble formation, deflation, heat, shock waves).

[0011] If the balloon ruptures or otherwise malfunctions during the generation of a treatment pulse, in currently available IVL devices, identifying the balloon failure and stopping treatment is under the control of a human operator. If the current system experiences a failure at the start of a pulse cycle, the system will continue to provide treatment sessions unless a human identifies and intervenes in the failure.

[0012] An example of a balloon integrity monitoring system is disclosed in U.S. Patent Publication No. 20210378743, published on December 9, 2021. However, this system is complex and involves a design with increased cross-profiles, which can negatively impact not only the system's cross-profiles but also its rigidity and cost. [Overview of the Initiative]

[0013] The present invention relates to an endovascular lithotripsy system having a balloon, such as one used for angioplasty, which can be filled with a fluid such as saline solution. It is known that saline solution is provided and used as the inflation fluid, and therefore saline solution can be a component of the fluid. It is also known that other fluids, such as contrast agents, are mixed with or provided with saline solution. The system may include at least one emitter or a pair of electrodes for generating treatment. For example, an energy wave or high-pressure acoustic energy wave in a balloon having fluid inside may provide treatment. The system also includes a sensor for detecting damage to the balloon, such as rupture. The system further includes a processor for receiving information on balloon damage or rupture, and a control module having the ability to prevent the system from energizing the emitter or electrodes when balloon damage or unacceptable degradation or anticipated imminent failure is detected.

[0014] In another embodiment, the endovascular lithotripsy system described herein includes a balloon, such as one used for angioplasty, which can be filled with fluid; at least one emitter or a pair of electrodes for generating energy waves or high-pressure acoustic energy waves within the fluid-filled balloon; a sensor located in the proximal region of the catheter assembly for detecting damage or other malfunction or impending failure of the balloon; and a control module having a microprocessor for receiving information about damage, rupture or failure of the balloon and for preventing the system from energizing the emitter or electrodes. The system can optionally assist a physician in avoiding an undesirable balloon rupture by automatically notifying of an impending malfunction of the balloon.

[0015] In one aspect of the present invention, an endovascular lithotripsy (IVL) system includes a catheter having a distal end, provided with an inflatable balloon and at least one emitter for generating energy waves within the balloon for conduction and IVL action to provide treatment to a lesion in the vascular system of a subject; a sensor operably associated with the balloon for monitoring the condition of the balloon and detecting an undesirable level of damage to the balloon; and a control system operably connected to the sensor and emitter to prevent further generation of energy waves and further IVL action by the emitter if the sensor determines an undesirable level of damage to the balloon.

[0016] The sensor may include a pressure sensor that monitors the fluid pressure in either the balloon or the pressure fluid lumen of the catheter that provides the inflation fluid to the balloon, in order to directly or indirectly monitor the fluid pressure within the balloon. To directly monitor the fluid pressure within the balloon, the pressure sensor may be located on the catheter shaft portion of the IVL system within the balloon. Alternatively, the pressure sensor may be located on a component of the catheter that is positioned outside the patient's vascular system and indirectly connected to the balloon by the pressure fluid lumen of the catheter for balloon inflation.

[0017] The system may further include a high-voltage pulse generator that is electrically connected to the emitter and generates a spark in the balloon at the emitter when a high-voltage pulse is generated by the treatment initiation control module.

[0018] The system may further include an indicator function that provides the user with information about undesirable damage, at least when undesirable damage to the balloon is detected.

[0019] The system can include a plurality of sensors for monitoring the balloon and determining an undesirable level of damage to the balloon. A control module including a processor and a memory can also be provided, and the memory includes a program for controlling a fault detection algorithm.

[0020] Alternatively, at least one sensor can include an optical sensor for detecting harmful substances in the inflation fluid, and the presence of such harmful substances is correlated with an impending failure of the balloon. At least one sensor can include a MEMS pressure sensor.

[0021] In another aspect of the invention, a method of using an intravascular (IVL) system having an anti - activation function includes inserting a balloon, such as for angioplasty, into a blood vessel in the region of a lesion in a subject's vasculature, expanding the balloon at least partially, activating the IVL system to generate an energy wave within, such as for an angioplasty balloon, to provide treatment to the lesion, monitoring the condition of the angioplasty balloon, detecting an undesirable level of damage to the balloon, and then preventing activation of the system after an undesirable level of damage to the balloon is detected.

[0022] The method can further include providing the user with an indication that the IVL system is preventing further treatment using the IVL system and generation of energy waves within the balloon.

[0023] The various inventions disclosed herein address these problems, among others.

[0024] These drawings are illustrative of particular embodiments and, accordingly, are not intended to limit the present disclosure.

Brief Description of the Drawings

[0025] [Figure 1]A diagram schematically showing a system including a sensor according to the present invention. [Figure 2] A diagram schematically showing an intravascular balloon with a sensor for providing intravascular lithotripsy according to one aspect of the present invention. [Figure 3] A schematic flowchart showing a method according to another aspect of the present invention. [Figure 4] A schematic cross-sectional view of a catheter connector according to an embodiment of the present invention. [Figure 5] A schematic diagram of another embodiment of the present invention showing a system having a plurality of wave generation electrode pairs. [Figure 6] A diagram of the features of a particular IVL catheter, showing details of the working length of such an IVL catheter, the energy profile of the IVL catheter, and the provision of an optimized overlap zone within such an IVL catheter design.

Mode for Carrying Out the Invention

[0026] Unless otherwise defined in context, the following terms or phrases shall have the following meanings (in both their singular and plural forms).

[0027] The terms "conductor", "conductive", and "conduct" mean electrically conductive and refer to materials through which an electric current can flow easily. In some examples, a conductive material may be a thermally conductive material, but not necessarily so. Materials such as carbon black, gold, and metals are representative conductive materials.

[0028] The term “conductive path” refers to an effective path along which electric current flows, and may refer to, for example, the entire surface of a balloon on a component of the balloon coated with conductive material, or only a portion of the surface coated with conductive material, such as conductive stripes or a predetermined (e.g., rectangular) shape on the surface or layer of the balloon. Examples of ink-printed medical devices are described in U.S. Patents No. 5,836,874, No. 7,379,767, No. 9,7636,24, No. 9,913,594, and No. 10,751,000.

[0029] The term “endovascular lithotripsy device” includes devices that generate acoustic waves by spark or arc discharge between electrode components, but may also include devices that generate acoustic energy within a balloon via a laser energy source. Examples of such laser systems are described in U.S. Patent Nos. 11,058,492 and 11,246,569. Examples of electrically inductive systems are described in U.S. Patent Nos. 8,728,091, 9,642,673 and 10,850,078, and published U.S. Patent Application No. 2022-0054194. Any suitable energy source may be used to generate shock waves or acoustic waves. Examples include laser-based systems, spark-generating systems, ultrasonic systems, and high-intensity focused ultrasound (HIFU) systems.

[0030] The term "lithotripsy emitter" refers to an electrode-based system, and may also include laser or optical systems.

[0031] The term "angioplasty balloon material" refers to any material conventionally used for angioplasty balloons, including compliant balloons, semi-compliant balloons, and non-compliant balloons. Such materials include composite or multilayer materials. Compliant materials include silicone materials, polyurethane materials, or nitinol materials. In some embodiments, the angioplasty balloon material may include a balloon-in-balloon design, where the fluid filling the inner balloon is different from the fluid filling the outer balloon to take advantage of the insulating properties and sound velocity differences of the materials. Compliant, semi-compliant, and non-compliant materials may include nylon, polyurethane, silicone, polyethylene terephthalate (PET), and other biocompatible materials. The recommended burst pressure for angioplasty balloons is typically 4 to 20 atmospheres, more preferably 8 to 12 atmospheres, with one example being nylon 12 material with a rated burst pressure of approximately 9 to 12 atmospheres.

[0032] Referring to the figure, Figure 1 shows a system 10 according to the present invention, comprising a power supply 12 (in the form of a generator, but may alternatively be in the form of a laser or ultrasonic system), an optional handle H, a treatment delivery control unit 15, and an overwire G catheter 20 (e.g., disposable) having two lithotomy emitters 22 (shown in the form of arc electrodes, but may alternatively include optical emitters, laser emitters, or ultrasonic emitters) and a fluid-fillable balloon 24. The housing of the power supply 12 may also house a control module having a microprocessor, as will be described in more detail below. Optionally, an imaging marker band B may be provided. The system also includes a sensor S for detecting a malfunction of the balloon 24. In this embodiment, the sensor is shown mounted on the shaft of a catheter member including a passage or lumen for the guidewire G.

[0033] The emitter or electrode 22 is capable of generating shock waves or high-energy acoustic waves within the balloon 24. The emitter or electrode can be positioned within the balloon along a shaft member for holding the energy delivery component. The emitter or electrode may be positioned linearly along the longitudinal axis of the system or at different radial angles to provide more 360-degree effective treatment. In another embodiment, the shock wave can be generated outside the body, and the balloon may include an energy deflection or focusing element to receive the energy and direct it toward the lesion.

[0034] The balloon 24 may be placed in a deflated position to allow it to pass more easily through the patient's vascular system and reach the site of calcification. When used in the body, the balloon 24 is advanced to the treatment site and then inflated to a general pressure for angioplasty procedures (e.g., 4 atm), and treatment is initiated by the user activating the delivery control unit 15 (e.g., by pressing a button). In many cases, multiple treatment sessions (e.g., 8 or more) are performed before exceeding the maximum number of treatment sessions allowed.

[0035] Figure 2 shows the balloon 24 inflated to the treatment delivery state, in which state the lithotomy emitter 24 is "activated" to break up calcium (C). An optional indicator band B may be provided to enable visualization and proper positioning by using known imaging techniques. The balloon 24 is inflated to a typical angioplasty pressure (e.g., 4 atm) and the treatment is delivered. The balloon 24 may spontaneously expand due to its internal pressure during or immediately after treatment delivery (as the calcium block is broken or fragmented), opening the vessel for blood passage.

[0036] The material of the balloon 24 is inflated to a pressure well below its rupture pressure (e.g., 10 atm) to avoid balloon failure. The system also includes a sensor S for detecting damage to the balloon, such as rupture. The location of the sensor S may vary depending on the embodiment. The sensor S can be located on the catheter shaft, as shown in Figure 1, or on the balloon material itself. For example, a conductive path to the sensor attached to the balloon may be provided by an ink-printed circuit component. Alternatively, the sensor S can be located near the proximal end of the disposable catheter 20, as described later in conjunction with Figure 5.

[0037] Sensor S should be located in a place where it will not be excessively interfered with by therapeutic energy therapy. Shields or baffles may be employed to protect some of the pressure sensors located within the balloon 24 from therapeutic energy that could normally damage the sensors.

[0038] Sensor S can be a pressure sensor that detects a sudden drop in pressure or when the balloon pressure falls below a predetermined level. Other types of sensors, such as strain gauges or temperature sensors, can also be used.

[0039] The pressure sensor may optionally be correlated to measure the pressure on the sensor due to the expansion of a flexible tube. By attaching the pressure sensor to a flexible tube section and / or a flexible diaphragm attached to the tube section, and by attaching it directly to the fluid, direct and indirect measurement of the viscous fluid (contrast agent / saline mixture) within the lumen becomes possible. This correlation between tube expansion and the pressure sensor eliminates direct fluid movement and / or contact between the sensor S and the fluid medium within the sensor S, as well as electrical signals within electrically coupled balloons. This type of measurement is seen in diaphragm sensors. JPEG2026517691000003.jpg40107

[0040] Some contrast agents are similar to sugar water and may contaminate the pressure sensor. The correlation between the expansion of this tube and the pressure sensor prevents direct fluid movement and / or contact between the sensor S and the fluid medium within the sensor, as well as electrical signals within the electrically coupled balloon. The pressure signal within the lumen may be monitored for an unacceptable or concerning rate of attenuation that suggests loss of adhesion or a hole / rupture of the balloon.

[0041] The pressure inside the balloon may also be monitored to measure the amount of fluid in the system. When the IVL system is activated and the balloon expands, the volume in the system increases and the pressure inside the system decreases. Continuous decay / rupture and the pressure increase / decrease due to changes in balloon volume may be distinguished by changes in the pressure profile.

[0042] The pressure sensor may detect malfunctions in balloon systems, such as those used in angioplasty, by means of:

[0043] Overinflation: One of the most common malfunctions in angioplasty balloons is overinflation, which can cause the balloon to rupture. A pressure sensor placed inside the balloon can directly detect the pressure inside the balloon and alert the medical team if the pressure exceeds a predetermined level. This pressure sensor can help prevent the balloon from rupturing and causing injury to the patient.

[0044] Leakage: Another potential failure mode for angioplasty balloons is leakage, which can occur if the balloon material is defective or the balloon is not properly inflated. Pressure sensors can detect a percentage drop in pressure within the balloon or a pressure drop to a threshold that suggests a leak and alert the medical team. This can help ensure the balloon is replaced before continuing the procedure, reducing the risk of complications.

[0045] Overall, pressure sensors can play a role in ensuring the safety and effectiveness of lithotomy procedures by detecting potential balloon malfunctions and alerting the medical team to take appropriate action.

[0046] The sensor S is preferably connected to a microprocessor that receives information about balloon damage or rupture. The system 10 may include a control module which may include a hardware microprocessor and memory operably connected together, the memory including programming which may include software or firmware for controlling any number of fault detection algorithms or tests when executed by the processor as described herein. The processor P may be programmed to prevent the system 10 from energizing the emitter or electrodes if there is a risk of further damage to the balloon, balloon failure, or imminent balloon failure. For example, if the sensor S detects a sudden pressure drop, the microprocessor may automatically stop the transmission of shock waves or high-energy acoustic waves to prevent further damage to the balloon or undesirable effects on the patient. In addition to sudden pressure drops, the pressure within the system (catheter and balloon) may be monitored for high-pressure spikes suggesting torsion or occlusion, or gradual leaks suggesting a problem with the balloon and a pressure drop. The processor may be partially or completely located in the power console or, alternatively, in the handle H, or, alternatively, partly located in the catheter itself for the advantage of possible response time.

[0047] Optionally, the microprocessor may be programmed to temporarily shut down the pressure monitoring system during the very short duration of the therapeutic energy pulse. This strategy may be employed to help filter out interference from the system.

[0048] The position of the sensor S may vary. Referring to Figure 5, a system 10' is shown having multiple (5) emitters 22', a slightly different guidewire G system, a balloon 24', and a sensor S located near the proximal-distal end of the catheter. Figure 4 shows a cross-sectional view of a catheter connector showing one embodiment of the location of the wire for the emitter and the passage for the fluid for the pressure sensor and balloon. Such a wire includes part of a conductive path for delivering energy to the emitter.

[0049] Figure 5 also shows an optional or alternative sensor S'' of the pressure sensor configuration in the proximal portion of the catheter assembly.

[0050] In one embodiment, the pressure sensor is located inside (outside the body) the hub of the catheter assembly 20'. Considering that the balloon may be semi-rigid / rigid and the fluid is incompressible (except air), the extracorporeal pressure will be the same as the internal pressure. This position has the advantage of making the pressure sensor reusable. This also makes the sensor S relatively less susceptible to interference from electrical signals and high-energy pulses that may occur during treatment initiation.

[0051] The sensor S may be composed of a MEMS or optical fiber, such as a handle pressure sensor for monitoring the pressure lumen of the PVAD. The pressure sensing element S in this embodiment operates in series with the pressure expansion lumen of a device that contains a commercially available indefler. Furthermore, balloon inflation and inflation regulation may be controlled and managed using a commercially available indefler.

[0052] In another embodiment, the sensor S may include an optical sensor for detecting corrosive material from the electrode and other harmful substances whose presence may correlate with an impending failure of the balloon.

[0053] It should be noted that the processor or microprocessor may be programmed to identify balloon failure or impending balloon failure by processing information from various sources. For example, the system may count the number of therapeutic pulses delivered to a particular balloon, the system may also have an optical detector to detect the presence of harmful substances in the balloon due to electrode wear, and finally, the system's processor may 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 in the balloon and a decrease in balloon pressure, the system may automatically shut down as an additional safety measure beyond simple pulse counting, even though it is below the therapeutic limit.

[0054] Commercial IVL devices operate at voltages slightly below 3000 volts and include currents of 20-300 amperes. This invention can enable the use of higher voltages and / or currents or power while safely protecting the patient. The control module can provide higher energy therapeutic signals, thereby adjusting the balloon's lifespan downwards. This invention also reduces the burden on the physician operator by minimizing distractions during the procedure.

[0055] Referring here to Figure 3, in another embodiment of the present invention, the present invention includes a method for using an intravascular system having a therapeutic delivery prevention function, comprising the steps of: inserting a balloon, such as one used for angioplasty, into a blood vessel in the region of a lesion; inflating the balloon 24 at least partially (see, for example, Figure 2); providing treatment to the system in step 101 to generate shock waves or high-energy acoustic waves in the balloon, such as one used for angioplasty, in order to provide treatment to the lesion; monitoring the condition of the balloon, such as one used for angioplasty, 103; detecting an undesirable level of damage to the balloon in step 105; and stopping the operation of the system in step 107 after an undesirable level of damage to the balloon has been detected. Optionally, the system may notify the user in step 109 of the interruption of therapeutic energy utilization. If no balloon failure is detected, the system 10 may continue to deliver therapeutic energy in step 111.

[0056] The endovascular lithotripsy systems and methods described herein assist physicians in avoiding undesirable balloon ruptures by automatically notifying them of impending balloon failures. This feature can improve the level of safety for patients undergoing endovascular lithotripsy procedures.

[0057] The devices shown in the drawings illustrate exemplary systems for using the present invention. Note that the present invention may also be used in conjunction with systems described in the following patent applications (their entire contents incorporated herein by reference). 1. U.S. Provisional Patent Application No. 63 / 434,912, “INTRAVASCULAR LITHOTRIPSY DEVICES AND SYSTEMS HAVING SPARK MONITORING FEEDBACK,” Filing Date: December 22, 2022, or 2. U.S. Provisional Patent Application No. 63 / 425,169, “INTRAVASCULAR LITHOTRIPSY DEVICES AND SYSTEM,” Filing Date: November 14, 2022 3. U.S. Provisional Patent Application No. 63 / 416,231, "CATHETER SYSTEM WITH FORWARD FACING ELECTRODES FOR CREATING ENERGY WAVES," Filing Date: October 14, 2022 4. U.S. Provisional Patent Application No. 63 / 458,728, "INTRAVASCULAR LITHOTRIPSY DEVICES AND SYSTEMS WITH ENERGY WAVE DETECTION," Filing Date: April 12, 2023

[0058] The present invention is particularly suitable for use in forward-acting (e.g., axial) systems, as described in the above patent application.

[0059] Depending on the example, it should be understood that any particular act or event of any of the methods described herein may be performed in a different order, and may be added, combined, or omitted entirely (for example, not all described acts or events are necessarily required for the practice of the method). Furthermore, in certain examples, acts or events may be performed not sequentially, but concurrently, for example, through multithreading, interrupt handling, or multiple processors. In addition, although certain 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 may be performed by a combination of units or circuits associated with, for example, a medical device.

[0060] In one or more examples, the functions described may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored on a computer-readable medium as one or more instructions or codes and executed by a hardware-based processing unit. Computer-readable mediums may include computer-readable storage media corresponding to tangible media such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium accessible by a computer that can be used to store desired program code in the form of instructions or data structures).

[0061] Therefore, instructions may 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 logic arrays (FPGAs), or other equivalent integrated circuits or discrete logic circuits. Accordingly, the terms “microprocessor” or “processor” as used herein may refer to any of the aforementioned structures or any other structure suitable for implementing the technique described herein. Furthermore, this technique can be fully implemented in one or more circuits or logic elements.

[0062] Accordingly, medical devices or systems have been presented in the foregoing description with reference to specific examples. It should be understood that the various embodiments disclosed herein may be combined in combinations other than those specific to those presented in the accompanying drawings. It is recognized that various modifications may be made to the examples referenced without departing from the scope of this disclosure and the following claims.

[0063] The descriptions of the present invention and its applications described herein are illustrative and are not intended to limit the scope of the invention. Within the scope of the invention, features of various embodiments may be combined with other embodiments. The embodiments disclosed herein are modifiable and can be modified, and those skilled in the art will be able to understand practical alternatives and equivalents of various elements of the embodiments by examining this patent document. These and other modifications of the embodiments disclosed herein may be made without departing from the scope and spirit of the invention. [Explanation of Symbols]

[0064] 10 Systems 12 Power supply 15 Treatment Delivery Control Unit 20 Catheters 22 Emitter 24 Balloons

Claims

1. An endovascular lithotripsy (IVL) system comprising: a catheter having an inflatable balloon and a distal end provided with at least one emitter for generating energy waves within the balloon for conduction and IVL action to provide treatment to a lesion in the vascular system of a subject; a sensor operably associated with the balloon for monitoring the state of the balloon and detecting an undesirable level of damage to the balloon; and a control system operably connected to the sensor and the emitter to prevent further generation of energy waves and further IVL action by the emitter if the sensor determines an undesirable level of damage to the balloon.

2. The system according to claim 1, wherein the sensor includes a pressure sensor that monitors the fluid pressure in either the balloon or the pressure fluid lumen of the catheter that provides the inflation fluid to the balloon, in order to directly or indirectly monitor the fluid pressure in the balloon.

3. The system according to any one of claims 1 to 2, wherein the pressure sensor is provided on the catheter shaft portion of the IVL system within the balloon in order to directly monitor the fluid pressure within the balloon.

4. The system according to any one of claims 1 to 3, wherein the pressure sensor is provided on a component of the catheter positioned outside the vascular system of the subject and is indirectly connected to the balloon by the pressure fluid lumen of the catheter for the inflation of the balloon.

5. The system according to any one of claims 1 to 4, further comprising a high-voltage pulse generator electrically connected to the emitter for generating a spark in the balloon at the emitter when a high-voltage pulse is generated by a treatment initiation control module.

6. The system according to any one of claims 1 to 5, further comprising an indicator function that provides the user with at least information regarding the undesirable damage to the balloon when such undesirable damage is detected.

7. The system according to any one of claims 1 to 6, further comprising a plurality of sensors for monitoring the balloon and determining the undesirable level of damage to the balloon.

8. The system according to any one of claims 1 to 7, wherein the control module includes a processor and memory, and the memory includes programming for controlling a fault detection algorithm.

9. The system according to any one of claims 1 to 8, wherein the sensor includes an optical sensor for detecting harmful substances in the expanding fluid, and the presence of the harmful substances correlates with an impending failure of the balloon.

10. The system according to any one of claims 1 to 9, wherein the sensor includes a MEMS pressure sensor.

11. A method for using an intravascular (IVL) system having an activation prevention function, comprising the steps of: inserting a balloon, such as one used for angioplasty, into a blood vessel in the region of a lesion in the vascular system of a subject; at least partially inflating the balloon; activating the IVL system to generate an energy wave in the balloon, such as one used for angioplasty, in order to provide treatment to the lesion; monitoring the condition of the angioplasty balloon; detecting an undesirable level of damage to the balloon; and subsequently preventing the activation of the system after the detection of the undesirable level of damage to the balloon.

12. The method according to claim 11, further comprising the step of providing the user with an indication that the IVL system is preventing further treatment using the IVL system and that the IVL system is preventing the generation of energy waves within the balloon.

13. The method according to any one of claims 11 to 12, wherein the sensor includes a pressure sensor that monitors the fluid pressure in either the balloon or the pressure fluid lumen of the catheter that provides the inflation fluid to the balloon, in order to directly or indirectly monitor the fluid pressure in the balloon.

14. The method according to any one of claims 11 to 13, wherein the pressure sensor is provided on the catheter shaft portion of the IVL system within the balloon in order to directly monitor the fluid pressure within the balloon.

15. The method according to any one of claims 11 to 14, wherein the pressure sensor is provided on a component of the catheter positioned outside the vascular system of the subject and is indirectly connected to the balloon by the pressure fluid lumen of the catheter for the inflation of the balloon.

16. The method according to any one of claims 11 to 15, further comprising a high-voltage pulse generator electrically connected to the emitter for generating a spark in the balloon at the emitter when a high-voltage pulse is generated by a treatment initiation control module.

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

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

19. The method according to any one of claims 11 to 18, wherein the sensor includes an optical sensor for detecting harmful substances in the expanding fluid, and the presence of the harmful substances correlates with an impending failure of the balloon.

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

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