Parameter monitoring for an intravascular lithotripsy system

Abstract

Included in the present disclosure is a system, including an elongated body including an inner elongated structure including a guidewire lumen. The system may include a pressure wave emitter disposed about the elongated body and including a first electrode and a second electrode, arranged to define a spark gap between the first electrode and the second electrode. The first electrode may be configured to transmit electricity across the spark gap to the second electrode to cause a spark configured to enable a pressure wave to be generated. The system may include a generator configured to couple to the pressure wave emitter and deliver the electricity thereto via an electrical pathway. The system may include a detector configured to detect an aspect of i) the electricity along the electrical pathway, ii) an aspect of the pressure wave emitter, iii) an aspect of the generator, or iv) combinations thereof.

Description

PARAMETER MONITORING FOR AN INTRAVASCULAR LITHOTRIPSYSYSTEM

[0001] The entire contents of the following application are incorporated herein: U.S. Provisional Patent Application No. 63 / 631,409; filed April 8, 2024; and entitled PARAMETER MONITORING FOR AN INTRAVASCULAR LITHOTRIPSY SYSTEM.Background

[0002] During an intravascular lithotripsy (IVL) procedure, a clinician uses a catheter configured to break apart calcified-plaque lesions within a patient’s vasculature. Some such methods include the creation and rapid collapse of cavitation bubbles to create a shock wave which causes this calcification break-up.SUMMARY

[0003] Included in the present disclosure is a system, including an elongated body including an inner elongated structure including a guidewire lumen. In some embodiments, the system includes a pressure wave emitter disposed about the elongated body and including a first electrode and a second electrode. According to some embodiments, the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode. The first electrode may be configured to transmit electricity across the spark gap to the second electrode to cause a spark, such that the spark is configured to enable a pressure wave to be generated. In some embodiments, the system includes a generator configured to couple to the pressure wave emitter and deliver the electricity thereto via an electrical pathway. According to some embodiments, the system includes a detector configured to detect an aspect of i) the electricity along the electrical pathway, ii) an aspect of the pressure wave emitter, iii) an aspect of the generator, or iv) combinations thereof.

[0004] The elongated body may include an inner elongated structure, the inner elongated structure including the guidewire lumen. In some embodiments, the pressure wave emitter is positioned along a central longitudinal axis of the elongated body.

[0005] According to some embodiments, the aspect is a voltage. The detector may be configured to monitor voltage rails along the electrical pathway. In some embodiments, the detector is configured to monitor a high voltage output. According to some embodiments, the system further includes a direct current (DC) / DC converter, wherein the DC / DC converter provides the high voltage output.

[0006] The detector may be configured to detect if the voltage i) exceeds a high voltage value, ii) is less than a low voltage value, or iii) combinations thereof. In some embodiments, the high voltage value is indicative of i) voltage too high to exceed creepage, ii) voltage too high for clearance, iii) electrical isolation, or iv) combinations thereof. According to some embodiments, the low voltage value is indicative of voltage too low to cross the spark gap.

[0007] The aspect may be a current. In some embodiments, the detector is configured to monitor a current transformer along the electrical pathway. According to some embodiments, the detector is configured to detect if the current i) exceeds a high current value, ii) is lower than a low current value, or iii) combinations thereof. The high current value may be indicative of a power that is too high. In some embodiments, the low current value is indicative of i) a power that is too low to deliver a pulse to the emitter, ii) a false firing, or iii) combinations thereof.

[0008] According to some embodiments, the aspect is an impedance. The generator may be configured to provide a low-voltage pulse to the pressure wave emitter. In some embodiments, the low-voltage pulse is insufficient to cross the spark gap. According to some embodiments, the impedance is measured at a junction of the electrical pathway. The impedance may be indicative of a health of the elongated body. In some embodiments, the detector is configured to detect when the impedance is outside of a nominal impedance range.

[0009] According to some embodiments, the aspect is an internal load. The generator may be configured to deliver a pulse. In some embodiments, the pulse is confined within the generator. According to some embodiments, the system further includes a relay electrically isolated from the electrical pathway. The relay may be configured to deliver the pulse to the internal load. In some embodiments, the internal load is configured to represent a nominal load of the pressure wave emitter. According to some embodiments, the electricity is prevented from flowing when the pulse is outside of the nominal load.

[0010] The electricity may be prevented from flowing when i) the voltage exceeds the high voltage value, ii) the voltage is lower than the low voltage value, iii) the current exceeds the high current value, iv) the current is lower than the low current value, v) the impedance is outside of the nominal impedance range, vi) the pulse is outside of the nominal load, or vii) combinations thereof.

[0011] In some embodiments, the system further includes a delay flip-flop electrically coupled to the electrical pathway, wherein the delay flip-flop is configured to perpetually latch when i) the voltage exceeds the high voltage value, ii) the voltage is lower than the low voltage value, iii) the current exceeds the high current value, iv) the current is lower than the low currentvalue, v) the impedance is outside of the nominal impedance range, vi) the pulse is outside of the nominal load, or vii) combinations thereof. According to some embodiments, a perpetually latched delay flip-flop is indicative of a non-recoverable fault state. The non-recoverable fault state may be recoverable through a reboot of the system.

[0012] In some embodiments, the system further includes an insulated-gate bipolar transistor (IGBT) electrically coupled to the electrical pathway, wherein the IGBT is configured to open and thereby electrically isolate the pressure wave emitter from the electrical pathway when i) the voltage exceeds the high voltage value, ii) the voltage is lower than the low voltage value, iii) the current exceeds the high current value, iv) the current is lower than the low current value, v) the impedance is outside of the nominal impedance range, vi) the pulse is outside of the nominal load, or vii) combinations thereof.

[0013] According to some embodiments, the system provides information to a user when i) the voltage exceeds the high voltage value, ii) the voltage is lower than the low voltage value, iii) the current exceeds the high current value, iv) the current is lower than the low current value, v) the impedance is outside of the nominal impedance range, vi) the pulse is outside of the nominal load, or vii) combinations thereof. The information may be i) permissible or ii) impermissible by the user.

[0014] In some embodiments, the system is configured to self-test i) when the voltage exceeds the high voltage value, ii) when the voltage is lower than the low voltage value, iii) the current exceeds the high current value, iv) the current is lower than the low current value, v) the impedance is outside of the nominal impedance range, vi) the pulse is outside of the nominal load, vii) during a rest period, or viii) combinations thereof.

[0015] According to some embodiments, a pulse cycle is configured to end immediately when i) the voltage exceeds the high voltage value, ii) the voltage is lower than the low voltage value, iii) the current exceeds the high current value, iv) the current is lower than the low current value, v) the impedance is outside of the nominal impedance range, vi) the pulse is outside of the nominal load, or vii) combinations thereof. The pulse cycle may be configured to continue indefinitely.

[0016] In some embodiments, a number of pulses in a cycle is adjusted when i) the voltage exceeds the high voltage value, ii) the voltage is lower than the low voltage value, iii) the current exceeds the high current value, iv) the current is lower than the low current value, v) the impedance is outside of the nominal impedance range, vi) the pulse is outside of the nominal load, or vii) combinations thereof.

[0017] According to some embodiments, a length of a rest period is adjusted when i) the voltage exceeds the high voltage value, ii) the voltage is lower than the low voltage value, iii) the current exceeds the high current value, iv) the current is lower than the low current value, v) the impedance is outside of the nominal impedance range, vi) the pulse is outside of the nominal load, or vii) combinations thereof. The length of the rest period may be configured to permit a capacitor to be fully discharged and recharged.

[0018] In some embodiments, i) the voltage exceeding the high voltage value, ii) the voltage falling lower than the low voltage value, iii) the current exceeding the high current value, iv) the current falling lower than the low current value, v) the impedance falling outside of the nominal impedance range, vi) the pulse falling outside of the nominal load, or vii) combinations thereof is indicative of a manufacturing defect. According to some embodiments, the manufacturing defect is the first electrode being i) too close to the second electrode or ii) too far from the second electrode.

[0019] i) The voltage exceeding the high voltage value, ii) the voltage falling lower than the low voltage value, iii) the current exceeding the high current value, iv) the current falling lower than the low current value, v) the impedance falling outside of the nominal impedance range, vi) the pulse falling outside of the nominal load, or vii) combinations thereof may be indicative of wear and tear on a component of the system.

[0020] In some embodiments, the pressure wave emitter is a first pressure wave emitter and the spark gap is a first spark gap, the system further comprising a second pressure wave emitter comprising a third electrode and a fourth electrode arranged to define a second spark gap between the third electrode and the fourth electrode. According to some embodiments, the detector is configured to individually detect i) the voltage, ii) the current, iii) the impedance, iv) the internal load, or v) combinations thereof of the first pressure wave emitter and the second pressure wave emitter. The manufacturing defect may be the first pressure wave emitter being i) too close to the second pressure wave emitter or ii) too far from the second pressure wave emitter.

[0021] In some embodiments, the detector is located within the generator. According to some embodiments, the generator is configured to prevent the electricity from flowing. The system may further include a microcontroller communicatively coupled to the electrical pathway. In some embodiments, the microcontroller is configured to prevent the electricity from flowing when the voltage is outside of a nominal voltage range.

[0022] Also included in the present disclosure is an elongated body including a guidewire lumen. In some embodiments, the system includes a balloon positioned at a first end of theelongated body, the balloon configured to receive an inflation fluid to inflate the balloon. According to some embodiments, the system includes an inflation lumen extending from a second end of the elongated body into the balloon, thereby forming a fluid pathway therebetween. The system may include a pressure wave emitter disposed about the elongated body and including a first electrode and a second electrode. In some embodiments, the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode. According to some embodiments, the first electrode is configured to transmit electricity across the spark gap to the second electrode to cause a spark, such that the spark is configured to enable a pressure wave to be generated. The system may include a generator configured to couple to the pressure wave emitter and deliver the electricity thereto via an electrical pathway. In some embodiments, the system includes a detector configured to detect an aspect of i) the inflation fluid along the fluid pathway, ii) the balloon, or iii) combinations thereof.

[0023] According to some embodiments, the elongated body includes an inner elongated structure, the inner elongated structure comprising the guidewire lumen. The pressure wave emitter may be positioned along a central longitudinal axis of the elongated body.

[0024] In some embodiments, the aspect of the balloon is a balloon pressure. According to some embodiments, the detector includes a pressure sensor configured to measure the balloon pressure. The pressure sensor may be located along the fluid pathway. In some embodiments, the system further includes i) a handle, ii) a hub, or iii) a sled, i) the handle, ii) the hub, or iii) the sled coupled to one or more of the generator and the elongated body, wherein the pressure sensor is disposed on or about i) the handle, ii) the hub, or iii) the sled.

[0025] According to some embodiments, the detector is configured to detect an external temperature or a temperature relating to the system. The external temperature may be indicative of an ambient temperature. In some embodiments, the detector includes a thermocouple, a resistance temperature detector (RTD), a thermistor, or any combination thereof, each configured to measure the external temperature. According to some embodiments, the detector includes the thermocouple, the thermocouple being disposed on an interior surface of the balloon, on an exterior surface of the balloon, or within the balloon.

[0026] The aspect of the inflation fluid may be a temperature of the inflation fluid. In some embodiments, the detector includes an infrared sensor configured to measure the temperature of the inflation fluid, corresponding to the external temperature. According to some embodiments, the balloon includes the infrared sensor. The detector may include an infrared sensor configured to measure the temperature of the inflation lumen.

[0027] Also included in the present disclosure is a system, including an elongated body including a guidewire lumen. In some embodiments, the system includes a pressure wave emitter disposed about the elongated body and comprising a first electrode and a second electrode. According to some embodiments, the system the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode. The first electrode may be configured to transmit electricity across the spark gap to the second electrode to cause a spark, such that the spark is configured to enable a pressure wave to be generated. In some embodiments, the system includes a generator configured to couple to the emitter and deliver the electricity thereto via an electrical pathway. According to some embodiments, the system includes an optical fiber extending at least partially along a length of the elongated body, the optical fiber defining an optical pathway. The system may include a detector configured to detect an aspect of i) the spark, ii) the pressure wave, or iii) both.

[0028] In some embodiments, the elongated body includes an inner elongated structure, the inner elongated structure including the guidewire lumen. According to some embodiments, the pressure wave emitter is positioned along a central longitudinal axis of the elongated body.

[0029] The aspect of the pressure wave may be an ultrasound intensity. In some embodiments, the ultrasound intensity is indicative of a pressure of each pulse associated with the pressure wave. According to some embodiments, the detector includes a hydrophone configured to measure i) the ultrasound intensity, ii) a refractive index change as a function of time, or iii) both. Measuring the ultrasound intensity may provide a feedback on whether the pressure wave being generated is appropriate for a treatment.

[0030] Also included in the present disclosure is a system, including an elongated body including a guidewire lumen. In some embodiments, the system includes a pressure wave emitter disposed about the elongated body and comprising a first electrode and a second electrode. According to some embodiments, the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode. The first electrode may be configured to transmit electricity across the spark gap to the second electrode to cause a spark, such that the spark is configured to enable a pressure wave to be generated. In some embodiments, the system includes a generator configured to couple to the emitter and deliver the electricity thereto via an electrical pathway. According to some embodiments, the system includes a detector configured to determine a humidity of an ambient environment i) about the system, ii) within the generator, or iii) both.

[0031] The detector may include a hygrometer configured to measure the humidity.

[0032] Also included in the present disclosure is a system, including an elongated body including a guidewire lumen. In some embodiments, the system includes a pressure wave emitter disposed about the elongated body and comprising a first electrode and a second electrode. According to some embodiments, the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode. The first electrode may be configured to transmit electricity across the spark gap to the second electrode to cause a spark, such that the spark is configured to enable a pressure wave to be generated. In some embodiments, the system includes a generator configured to couple to the emitter and deliver the electricity thereto via an electrical pathway. According to some embodiments, the system includes a detector configured to determine an elastic modulus of a vessel wall within a subject.

[0033] The detector may be further configured to perform an intravascular ultrasound (IVUS) configured to map a treatment segment, so as to map a calcified lesion on the vessel wall.

[0034] In some embodiments, the system further includes a first imaging electrode proximal to the pressure wave emitter. According to some embodiments, the system further includes a second imaging electrode distal to the pressure wave emitter. The first imaging electrode and the second imaging electrode may be configured to map the treatment segment.

[0035] In some embodiments, the system further includes a camera at a distal end of the elongated body configured to map a calcified lesion. According to some embodiments, the generator is configured to deliver an amount of electricity to the pressure wave emitter based on the mapped treatment segment.

[0036] The pressure wave emitter may be a first pressure wave emitter and the spark gap may be a first spark gap. In some embodiments, the system further includes a second pressure wave emitter including a third electrode and a fourth electrode arranged to define a second spark gap between the third electrode and the fourth electrode. According to some embodiments, the generator is configured to deliver electricity to the first pressure wave emitter and the second pressure wave emitter in a sequence based on the mapped treatment segment.

[0037] The pressure wave emitter may be a first pressure wave emitter and the spark gap may be a first spark gap. In some embodiments, the system further includes a second pressure wave emitter including a third electrode and a fourth electrode arranged to define a second spark gap between the third electrode and the fourth electrode. According to some embodiments, the generator is configured to deliver a different amount of electricity to the first pressure wave emitter and the second pressure wave emitter based on the mapped treatment segment.

[0038] Also included in the present disclosure is a system, including an elongated body including a guidewire lumen. In some embodiments, the system includes a pressure wave emitter disposed about the elongated body and comprising a first electrode and a second electrode. According to some embodiments, the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode. The first electrode may be configured to transmit electricity across the spark gap to the second electrode to cause a spark, such that the spark is configured to enable a pressure wave to be generated. In some embodiments, the system includes a generator configured to couple to the emitter and deliver the electricity thereto via an electrical pathway. According to some embodiments, the system includes a detector configured to determine a maximum acceleration experienced by the generator, the elongated body, the detector, the pressure wave emitter, or any combination thereof.

[0039] The detector may include a gravity -force sensor, an accelerometer, or both.

[0040] Also included in the present disclosure is an elongated body including a guidewire lumen. In some embodiments, the system includes a balloon positioned at a first end of the elongated body, the balloon configured to receive an inflation fluid to inflate the balloon. According to some embodiments, the system includes an inflation lumen extending from a second end of the elongated body into the balloon, thereby forming a fluid pathway therebetween. The system may include a pressure wave emitter disposed about the elongated body and including a first electrode and a second electrode. In some embodiments, the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode. According to some embodiments, the first electrode is configured to transmit electricity across the spark gap to the second electrode to cause a spark, such that the spark is configured to enable a pressure wave to be generated. The system may include a generator configured to couple to the pressure wave emitter and deliver the electricity thereto via an electrical pathway. In some embodiments, the system includes a detector configured to determine a bubble formation within the fluid.

[0041] According to some embodiments, the bubble formation is indicative of an increased amount of gas in the fluid. The detector may include i) an x-ray device configured to measure the bubble formation, ii) an optical fiber configured to measure the bubble formation, or iii) both.

[0042] In some embodiments, the detector includes an array of photodiodes configured to detect light, thereby enabling detection of the bubble formation. According to some embodiments, the array of photodiodes is configured to receive a back reflection from a distalend of an optical fiber. The back reflection from the distal end of the optical fiber may include a Fresnel reflection.

[0043] In some embodiments, the detector includes an ultrasound device configured to measure an ultrasound intensity, and wherein the ultrasound intensity is indicative of the bubble formation. According to some embodiments, the ultrasound intensity is indicative of a pressure of each pulse of the pressure wave. The detector may include a hydrophone configured to measure the ultrasound intensity, such that a change thereof is indicative of the bubble formation.

[0044] Also included in the present disclosure is a system, including an elongated body including a guidewire lumen. In some embodiments, the system includes a pressure wave emitter disposed about the elongated body and comprising a first electrode and a second electrode. According to some embodiments, the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode. The first electrode may be configured to transmit electricity across the spark gap to the second electrode to cause a spark, such that the spark is configured to enable a pressure wave to be generated. In some embodiments, the system includes a generator configured to couple to the emitter and deliver the electricity thereto via an electrical pathway. According to some embodiments, the system includes a first detector of any detector as described above. The system may include a second detector of any detector as described above. In some embodiments, the first detector is different from the second detector.

[0045] Also included in the present disclosure is an elongated body including a guidewire lumen. In some embodiments, the system includes a balloon positioned at a first end of the elongated body, the balloon configured to receive an inflation fluid to inflate the balloon. According to some embodiments, the system includes an inflation lumen extending from a second end of the elongated body into the balloon, thereby forming a fluid pathway therebetween. The system may include a pressure wave emitter disposed about the elongated body and including a first electrode and a second electrode. In some embodiments, the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode. According to some embodiments, the first electrode is configured to transmit electricity across the spark gap to the second electrode to cause a spark, such that the spark is configured to enable a pressure wave to be generated. The system may include a generator configured to couple to the pressure wave emitter and deliver the electricity thereto via an electrical pathway. In some embodiments, the system includes a first detector of any detector as described above, According to some embodiments, the system includes a seconddetector of any detector as described above. The first detector may be different from the second detector

[0046] In some embodiments, the detector is in communication with a processor configured to output a respective detection by the detector. According to some embodiments, the output includes a visual output depicted on a display that is in communication with the processor, an audio output, a communication sent to an interested party, an automatic shutdown of one or more components of the system, or any combination thereof.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] These and other features, aspects, and advantages are described below with reference to the drawings, which are intended to illustrate, but not to limit, the invention. In the drawings, like characters denote corresponding features consistently throughout similar embodiments.

[0009] FIG. 1 illustrates a diagrammatic view of an intravascular lithotripsy (IVL) system as it may appear inserted into a patient’s vasculature.

[0010] FIG. 2 illustrates a conceptual diagram of an example IVL system, including an energy generator and a catheter having a pressure-wave-emitter array within an interventional balloon.

[0011] FIG. 3. illustrates a conceptual block diagram illustrating some example components of the energy generator of FIG. 2.

[0012] FIG. 4 illustrates a conceptual block diagram of example components of the energy generator of FIG. 2 and their operative connection to the catheter of FIG. 2.

[0013] FIG. 5 illustrates a conceptual block diagram of example parameters detected by a pulse monitor.

[0014] FIG. 6 illustrates a conceptual block diagram of example parameters detected by a voltage monitor.

[0015] FIG. 7 illustrates a diagrammatic view of a circuit, according to some embodiments.

[0016] FIGS. 8A, 8B, and 8C illustrate diagrammatic views of wiring configurations, according to some embodiments.DETAILED DESCRIPTION

[0073] Although specific examples are disclosed below, inventive subject matter extends beyond the specifically disclosed examples to alternative examples and / or uses and modifications and equivalents thereof. Thus, the scope of the claims appended hereto is not limited by any of the particular examples described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed inany suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations, in turn, in a manner that may be helpful in understanding specific examples; however, the order of description should not be construed to imply that these operations are order-dependent. Additionally, the structures, systems, and / or devices described herein may be embodied as integrated or separate components.

[0074] For purposes of comparing various examples, certain aspects and advantages of these examples are described. Not necessarily all such aspects or advantages are achieved by any particular example. Thus, for example, various examples may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

[0075] Throughout the present disclosure, the terms “parameter” and “aspect” are used interchangeably and understood to mean the same thing. In either case, the parameter or aspect relates to a condition, either of a component of the system, the system as a whole, the treatment site within the patient, or the environment in which the operation is taking place, which is capable of being monitored in a meaningful way.

[0076] The systems as disclosed herein pertain to detecting and monitoring parameters

[0077] (e.g., aspects) of the system, individual components of the system, a treatment site within a patient, and / or the environment in which an operation is taking place. These include but are not limited to electrical aspects (e.g., voltage, current, etc.), fluidic aspects (e.g., bubble formation, fluid temperature, etc.), treatment site aspects (e.g., locations of greater calcification, vessel mapping, etc.), as well as miscellaneous aspects (e.g., maximum acceleration experienced by the system, humidity of the room, etc.).

[0078] Additionally, the systems as disclosed herein may be capable of reacting to these parameters when they fall outside of a nominal or expected range. For example, the systems herein may send an alert or other type of message to the operator to let the operator know that a value has fallen out of range. At this point, the operator may immediately stop the operation or review the message to find what parameter is outside of the nominal range in order to decide whether continuation of the operation is possible (i.e., a permissible error) or not (i.e., an impermissible error).

[0079] In additional or alternative embodiments, the systems as disclosed herein can automatically shut down the system or parts of the system in response to parameters falling outside of the nominal range. In systems including multiple electrodes, this may include preventing electricity from flowing to all of the electrodes at once or selecting specificelectrodes that are falling outside of the nominal range to cut off electrical flow in order to permit completion of the operation, when only shutting off one or more electrodes rather than the entire system is possible.

[0080] Degradation of individual electrodes may be monitored. The systems as described herein may perform self-checks for such degradation in order to deactivate specific electrodes, if needed. In this way, the pulse lifetime of the system may be extended through identifying and deactivating electrodes that are too degraded.

[0081] Additionally, or alternatively, an impedance check may be performed between emitters to ensure this impedance is not too high. Internal impedance checks may be performed between adjacent emitters before the treatment begins, and then additional measurements performed during rest periods may be performed in order to see if these impedance values are changing more than expected. The conductivity of the saline, or inflation fluid, may be characterized in order to optimize these measurements and / or provide a better baseline dynamic range.

[0082] During an intravascular lithotripsy (IVL) procedure, a clinician uses the formation and subsequent collapse of cavitation bubbles to generate high-energy pressure waves to disrupt calcified-plaque lesions within a patient’s vasculature. Some such IVL procedures include the generation of shock waves through electrode emitters or pairs of electrodes.

[0083] FIG. 1 illustrates a diagrammatic view of an IVL system 10 as it may appear inserted into a patient’s vasculature. The IVL system 10 may include an IVL device 20, perhaps including an interventional balloon. During a lesion-disintegration procedure, a clinician may advance the medical device through an access point 12 in the patient 30, such as the femoral or common femoral arteries, as depicted in FIG. 1. Other access points may include the radial artery, tibial artery, pedal artery, axial artery, peroneal artery, etc. The IVL device 20 may then be advanced through the vasculature of the patient 30 until it reaches the vessel 40 containing the treatment area 50. For IVL, the treatment area may include a calcified lesion 60.

[0084] As shown in FIG. 2, IVL device 20 includes a fluid-inflatable interventional balloon 208 and a pressure-wave emitter array 210 positioned within the balloon 208. The emitter array 210 may include one or more individual emitter 212a-212e. For example, interventional balloon 208, or a distal portion of elongated body 206 passing therethrough, may define a central longitudinal axis 214, and emitters 212a-212e may be distributed longitudinally along central longitudinal axis 214.

[0085] In particular, the example emitter array 210 shown in FIG. 2 includes a first emitter 212a, a second emitter 212b, a third emitter 212c, a fourth emitter 212d, and a fifth emitter 212e. While five emitters 212 are illustrated in FIG. 2, emitter array 210 of IVL device 20 mayinclude as few as one individual emitter and up to as many emitters as could reasonably fit within balloon 208. Each emitter 212 is configured to receive energy from energy generator 202 and use the received energy to generate and transmit high-energy pressure waves through balloon 208 and across the target treatment site. Emitters 212 may use the received energy to generate a cavitation bubble within the fluid inside balloon 208, propagating one or more high- energy pressure waves radially outward through balloon 208 and the calcified lesion. In some cases, but not all cases, a secondary set of high-energy pressure waves can subsequently result from the collapse of the fluid cavitation, further destabilizing the internal structure of the calcified-plaque lesion. In some examples, one or more of emitters 212 can include an electrical-based emitter configured to receive electrical energy from generator 202, such as via one or more conductive wires, and generate a spark between a pair of electrodes, thereby triggering the initial cavitation.

[0086] FIG. 3 is a block diagram illustrating some example components of energy generator 202 of FIG. 2. A power input 302 (e.g., for conductively coupling to a wall port or another electricity source) connects to power module 324 and an internal power supply 308. As shown in FIG. 3, power module 324 can include, as various, non-limiting examples, a high-voltage DC-DC converter 310, a high-voltage capacitor and transistor switch 312, a voltage and / or current measurement unit 316, and a device identification unit 322, configured to determine whether catheter 204 is an authorized device while catheter 204 is connected via catheter connector 304. For instance, energy generator 202 may be configured to disable energy output to catheter connector 304 when an unidentified device is connected.

[0087] Generator 202 can include a memory and one or more processors, such as processor 318 and / or user-interface-control processor 326. UI control processor 326 is configured to provide functionality for the user interface 334 of energy generator 202, such as a display screen, touch screen, buttons, or other manual controls enabling a user (e.g., a clinician) to operate the energy generator 202.

[0088] FIG. 4 is a block diagram illustrating some example components of an energy generator, such as energy generator 202 of FIG. 2. Some such components include a processor (such as processor 318) communicatively coupled to a display 404, a catheter detect 406, a button press detect 408, a programmable read-only memory (PROM) 410, and a trigger and emitter select 412. The catheter detect 406, button press detect 408, and PROM 410 components of the generator may be operatively coupled to a button handpiece and PROM 430 on the catheter 204. Although the PROM 410 has separate reference characters with respect to its applicationto the generator and catheter, it is understood that PROM 410 and the PROM involved in the button handpiece and PROM 430 may be the same.

[0089] While disclosed as a PROM above, it is understood that the system is capable of utilizing any type of read-only memory (ROM), including but not limited to masked read-only memory (MROM) (for instances where new information does not need to be written to the ROM), erasable programmable read-only memory (EPROM) (for instances where the user wants to be able to overwrite already existing or previously written instructions), Flash EPROM, and electrically erasable programmable read-only memory (EEPROM) (for increased speed of erasing and writing to the memory).

[0090] The trigger and emitter select 412 may be coupled to circuitry 414 which in turn may be coupled to a capacitor 416 which receives and stores electrical energy from a voltage supply 418. The circuitry 414 operatively couples to a pulse detect 420 and a pulse monitor 422. The pulse monitor 422 is configured to activate a voltage shut off 426, which is also operatively coupled to a voltage monitor 424.

[0091] In some examples, the circuitry 414 electrically couples to an emitter output 428 by way of a switch. This switch is further electrically coupled to the voltage shut off 426. In some examples, this means that the voltage shut off 426 may control the switch between the circuitry 414 and the emitter output 428, thereby preventing electricity from flowing between these components should an issue arise.

[0092] Stated another way, the capacitor 416 may be configured to provide electricity through any provided circuitry 414, while a trigger and emitter select 412 may permit an operator to allow electricity to flow through the circuitry to other listed components. The circuitry may electrically couple to a pulse detect 420 and pulse monitor 422, which monitors the pulses to ensure that there are no issues during operation. At the same time, a voltage monitor 424 may monitor the voltage to the same effect. If either of the pulse monitor 422 and voltage monitor 424 detect an issue during operation, they may cause the voltage shut off 426 to trigger a switch between the circuitry 414 and the emitter output 428 to prevent any emitters from receiving any further electricity until the problem has been resolved.

[0093] FIG. 5 illustrates a conceptual block diagram of example parameters detected by a pulse monitor, such as the pulse monitor 422 of FIG. 4. In some examples, the pulse monitor 422 detects a temperature 502 of the emitters 212, and is capable of preventing electricity from continuing to flow if this temperature 502 is outside of a nominal range, or too high. According to some examples, the pulse monitor 422 detects a pulse duration 504 of each pulse delivered through the catheter 204, and prevent electricity from flowing after this pulse duration 504 haspassed, thus causing pulses of a specific time interval.

[0094] The pulse monitor 422 may detect a pulse count 506. Perhaps the user wants a specific number of pulses to be delivered at a time, or the device has a life expectancy based on how many pulses occur. In such examples, the pulse monitor 422 prevents electricity from continuing to flow after the pulse count 506 has achieved the number of expected or desired pulses. In some examples, the pulse monitor 422 detects a pressure 508, such as the pressure 508 of a balloon 208 at the distal end of the catheter 204. In such examples, the pulse monitor 422 prevents electricity from flowing to the emitters 212 when this pressure 508 is outside of a nominal range, perhaps indicating overexpansion of the balloon 208 (pressure 508 is too high) or balloon 208 burst (pressure 508 is too low).

[0095] FIG. 6 illustrates a conceptual block diagram of example parameters detected by a voltage monitor, such as the voltage monitor 424 of FIG. 4. In some examples, the voltage monitor 424 detects a voltage 602 being delivered from the generator 202 to the emitters 212, and prevents electricity from flowing when this voltage 602 is outside of a nominal range. According to some examples, the voltage monitor 424 detects a current 604 passing through the circuitry 414, and prevents electricity from flowing when this current is outside of a nominal range. In examples where the voltage monitor 424 detects both a voltage 602 and a current 604, the voltage monitor is capable of calculating a power 614 running through the system, and prevent electricity from flowing when this power 614 is outside of a nominal range. While the example of voltage 602 and current 604 being used to calculate power 614 is used here, it is understood that other methods of calculating power 614 (such as energy delivered over time) may be implemented as well.

[0096] The voltage monitor 424 may detect an impedance 606 of the circuitry 414 or emitters 212 and prevent electricity from flowing when this impedance 606 is outside of a nominal range. In some examples, the voltage monitor 424 detects an energy 608 of the system and prevents electricity from flowing when this energy 608 is outside of a nominal range.

[0097] According to some examples, the voltage monitor 424 detects an internal load 610 on the system and prevents electricity from flowing when the internal load 610 is outside of a nominal range. The voltage monitor 424 may also detect a voltage recovery time 612 of the capacitor(s) 416, and prevent electricity from flowing when this voltage recovery time 612 is outside of a nominal range.

[0098] An additional aspect that may be monitored by the system is ultrasound intensity, which may correlate with a pressure of the pressure wave generated by the cavitation bubble when the electricity arcs from one electrode to another. Said pressure may be indicative of an aspectof the shock wave generated, particularly indicative of whether the pressure wave is appropriate for treatment. For example, too little or small of a pressure wave, may not be able to crack calcium within the vessel, whereas too much or large of a pressure wave may result in collateral damage about the vessel or treatment region of the patent.

[0099] The generator may include a detector configured to detect the ultrasound intensity of the pressure of the pressure wave generated. The detector may include a hydrophone configured to measure the ultrasound intensity of the pressure wave, a change in refractive index as a function of time, or both. The hydrophone and / or a sensor associated with a hydrophone may be disposed within, on, or otherwise about the balloon (as described herein about the elongated tube). For example, the hydrophone and / or a sensor associated with a hydrophone may be disposed within the inflation fluid to detect changes in ultrasound intensity thereabout.

[0100] Force sensors may also be implemented, such as via a ceramic element that produces a voltage based upon an intensity of the pulse and monitored from inside the generator. The pressure emitted by one emitter, or electrode pair, may be compared to the pressure emitter by adjacent emitters in order to infer the amount of energy transferred to the lesion, and / or the pulse current relative to the measured force. Good or bad lesion contact may be monitored through calculations related to these pressure measurements. Additionally, or alternatively, changes in the force over subsequent pulses may be used to determine if the therapeutic treatment has plateaued, needs to be adjusted, or has been completed.

[0101] Another aspect that may be monitored by the system relates to a humidity of an ambient environment surrounding the IVL system, a humidity within a housing of the generator, or both. Moisture in the generator may pose a risk for superheating water or other liquid, for example. The detector may include a hygrometer configured to measure the humidity. The hygrometer may be located outside, inside, or both, of the housing of the generator.

[0102] A further aspect that may be monitored by the system relates to a maximum acceleration experienced by the generator, the elongated body, the pressure wave emitter, other components of the IVL system, or any combination thereof. As such, the aspect may not necessarily be limited to a generator related aspect, but relate to structural and / or functional integrity of the IVL system components. For example, a maximum acceleration detected to exceed a certain threshold may result in the detector sending a communication to the processor (as described herein) to check for any faults and / or damage to components of the IVL system. This may have resulted if, for example, the IVL system or components thereof was dropped during transport, or movement otherwise (e.g., across a room, to a different room, etc.).

[0103] The detector may include a gravity-force sensor and / or an accelerometer, which maybe communicatively coupled to the generator (in addition or alternate to being communicatively coupled to the processor). The gravity-force sensor and / or an accelerometer may be configured to be read at time of power-up of the generator (for example).

[0104] An additional aspect that may be monitored by the system relates to a mapping of the treatment area with respect to the calcific lesion. This may be accomplished in multiple ways. One such manner includes coupling a camera to a distal end of the elongated body such that the camera can show an operator the state of the treatment site as the elongated body is inserted therethrough.

[0105] Sensing of the calcific status of the treatment site may be performed through complex impedance, providing information about the integrity of the calcific lesion. Measurements, such as density change via impedance over time, may be performed during rest periods in the treatment, and inform the user (e.g., operator) the “level” of integrity of the calcific lesion to inform the user how much more treatment may be needed. The user may also confirm this through fluorescence.

[0106] Another manner of mapping the treatment area includes the use of mapping electrodes. For example, a first mapping electrode may be placed proximal to the first pressure wave emitter (or proximal to the balloon), and a second mapping electrode may be placed distal to the last pressure wave emitter (or distal to the balloon). These mapping electrodes, together, may illustrate the state of the vessel between them, thereby describing the state of the effective treatment area.

[0107] An additional manner of mapping the treatment area includes the use intravascular ultrasound (IVUS) in order to determine an elastic modulus of the surrounding vessel wall - the elastic modulus indicative of a build up of calcification, or lack thereof. Such detection of decreased elastic modulus (indicative of higher calcification levels) may also provide feedback for the system regarding placement of the pressure wave emitters, such that a pressure wave emitter is located closest to the highest area of calcific build up.

[0108] Further aspects that may be monitored by the system relate to the fluid pathway, and may include an aspect of the inflation fluid and / or the balloon. These aspects may be monitored through detectors which are disposed within or about the balloon, within or about the elongated body, within or about the hub, and / or within or about a portion of the fluid pathway. As described herein, the inflation fluid may be delivered using a syringe to the fluid pathway (which may be via the hub for example), and wherein inflation fluid travels within the elongated body to inflate the balloon.

[0109] One such aspect may be a balloon pressure, wherein the detector includes a pressuresensor configured to measure the balloon pressure. A sudden decrease of a pressure of the balloon pressure and / or pressure within the fluid pathway may correspond to a rupture of the balloon or other fault. The detector may include a pressure sensor for detecting the pressure of the balloon and / or fluid pathway.

[0110] The pressure sensor may be located anywhere within the pressure pathway, wherein the pressure pathway defines a path beginning at the generator and ending at the balloon. In some examples, the pressure sensor may be within the generator. According to some examples, the pressure sensor may be within the handle, sled, and / or hub, the intermediary component connecting the elongated body to the generator (in examples including a separate generator). The pressure sensor may be present within the elongated body. In some examples, the pressure sensor may be located about the balloon. The pressure sensor may be present outside of these distinct components (generator, hub, elongated body) but within the pressure pathway.[OHl] Furthermore, in some examples, the pressure sensor may be present anywhere within the IVL system, including outside of the previously described pressure pathway. This could include a separate device outside of the medical device, such as an inflation device which is either a part of, or attached to, a hub connector. This inflation device may be adjacent, but outside of, the guidewire lumen. The pressure sensor may be a part of or attached to, such an inflation device.

[0112] Another such aspect may be a temperature of the inflation fluid. In some cases, a high temperature of the inflation fluid may result in at least partial vaporization of the inflation fluid, which may result in gas bubbles in the inflation fluid within the bubble (which may interfere with the pressure wave generation by the electrical arc, as described herein), and / or the vaporization may result in condensation upstream, such as within the generator.

[0113] The detector may be configured to measure a temperature of the inflation fluid, a temperature along the elongated body, a temperature of the balloon, and / or an external temperature (external to the IVL system for example), such as an ambient temperature. The detector may include a thermocouple, a resistance temperature detector (RTD), at thermistor, or any combination thereof. In one example, the detector as a thermocouple may be disposed on an interior surface of the balloon, on an exterior surface of the balloon, within the balloon, or a combination thereof.

[0114] A desired temperature of the inflation fluid may vary depending on the inflation fluid make-up. In some cases, a desired temperature of the inflation fluid is less than 30°C, less than 40°C, less than 45°C, less than 50°C, less than 60°C, or less than 75°C. The desired temperaturemay correlate to reducing or preventing the formation of bubbles and / or trapping gas within the inflation fluid. The desired temperature may be to reduce risk of injury and / or discomfort for a patient.

[0115] The detector may include an infrared sensor, configured to measure the temperature of the inflation fluid. The infrared sensor may be disposed about the elongated tube, and / or about the balloon.

[0116] The detector may also include a device to measure a direct current (DC) output. For example, the detector may be a multimeter. The DC current output may be correlated with a refractive index, which may be correlated with the temperature of the inflation fluid. For example, an increasing refractive index may be correlated with a decreasing inflation fluid (e.g., saline) temperature.

[0117] An additional such aspect may be a bubble formation within the inflation fluid within the balloon, as described herein (e.g., bubbles not formed through intentional cavitation). Bubbles within the inflation fluid may disrupt the formation of pressure waves by the electrical arcing. Accordingly, such bubble formation detection may be indicative of an amount, and / or an increased amount of gas in the fluid. The detector may include i) an x-ray device configured to measure the bubble formation and / or ii) an optical fiber configured to measure the bubble formation. In embodiments including an optical fiber, a hydrophone may additionally be located within the generator and configured to measure the ultrasound intensity of the pressure wave, a change in refractive index as a function of time, or both through the optical fiber.

[0118] Additionally, or alternatively, the detector may include an ultrasound device configured to measure an ultrasound intensity, which may be correlated with formation of a bubble within the fluid. For example, the ultrasound intensity may correlate with a pressure of each arc of electricity from electrode to another. The detector may also or alternatively include a hydrophone to measure the ultrasound intensity, to detect for bubble formation within the fluid.

[0119] In some embodiments, each detector is communicatively coupled with a processor such that the processor receives a communication if a given aspect is detected. In other embodiments, each detector may couple to a respective individual processor, or two or more of the detectors may be coupled to a common processor.

[0120] The processor may be configured to output a notification of a detection of an aspect. For example, the notification may be an alarm or other audible notification, a visual representation depicted on a display, an action by the IVL system (e.g., automatically preventing further electrical pulses), or any combination thereof.

[0121] The processor may be similar to the processor 318 depicted in FIG. 3 above, wherein the processor may also be configured to enable and / or control operation of the IVL system. The processor may also be different from processor 318, and may or may not be in communication with the processor 318.

[0122] The system may be capable of reacting to aspects and / or parameters being outside of nominal zones. For example, if a voltage is too high (indicative of voltage too high to exceed creepage, voltage that is too high for creepage, electrical isolation, etc.) or too low (e.g., too low to cross the spark gap between two electrodes), if a current is too high (indicative of a power being provided by the generator that is too high) or too low (indicative of a power that is too low to deliver a pulse to the emitter, a false firing, etc.), if an impedance is too low (indicative of a health of the elongated body), etc. All parameters and aspects as described and detailed above may cause the system to perform an action to prevent, or facilitate prevention, of damage to the treatment site and the medical device.

[0123] For example, the system may include a delay flip-flop, designed to permanently latch upon an aspect or parameter falling outside of a nominal range. This means that any present capacitor is able to finish its discharge for a current pulse of electricity to the pressure wave emitters, but after the pulse is completed (either successfully or as a failed pulse), the latched delay flip-flop may prevent a subsequent pulse from being sent. The delay flip-flop may affect the entire medical device, preventing electricity from being delivered to any present pressure wave emitter.

[0124] In some embodiments, but not all embodiments, the delay flip-flop interacts with a high voltage rail. The high voltage rail may be recoverable, indicating that the only concern is voltage that is in an indefinite state of being either too high or too low. A perpetually latched delay flip-flop is indicative of a non-recoverable fault state and the non-recoverable fault state is recoverable through a reboot of the system.

[0125] By way of another example, the delay flip-flop may come off of a current transformer which translates to a voltage value (i.e., two hundred amperes relates to four volts, or one hundred amperes relates to two volts, etc.). The high voltage rail may not directly interact with the delay flip-flop.

[0126] In additional or alternate embodiments, the system includes one or more insulated-gate bipolar transistors (IGBTs) electrically coupled to individual pressure wave emitters. FIG. 7 illustrates a diagrammatic view of a circuit, including such IGBTs, according to some embodiments. The diagram of FIG. 7 may be broken into three sections - the generator output 700, the catheter emitters 702, and the generator return 704.

[0127] The generator output 700 may include the high voltage 706 output for providing electricity to the pressure wave emitters 708a, 708b, 708c, 708d, and 708e, each of which is shown in the catheter emitters 702 section.

[0128] At the generator return 704, IGBTs 710 are shown, each individually coupled to a pressure wave emitter 708. E.g., IGBT 710a is electrically coupled to pressure wave emitter 708a, IGBT 710b is electrically coupled to pressure wave emitter 708b, IGBT 710c is electrically coupled to pressure wave emitter 708c, IGBT 710d is electrically coupled to pressure wave emitter 708d, and IGBT 710e is electrically coupled to pressure wave emitter 708e.

[0129] In some embodiments, the parameters and aspects with respect to the flow of electricity as described above may be individually monitored for each pressure wave emitter 708, independently. This may occur via a microcontroller 712 electrically coupled to the IGBT 710. When a parameter or aspect falls outside of a nominal range, the IGBT 710 may be configured to open and thereby electrically isolate the pressure wave emitter 708 from the electrical pathway. In this way, if only a single pressure wave emitter 708 is not performing properly, an operator may choose to continue the procedure with that pressure wave emitter 708 removed. This may bypass the need for the operator to stop operation if there are still enough pressure wave emitters 708 that fall within a nominal range of the parameters and aspects to finish the procedure.

[0130] FIGS. 8 A, 8B, and 8C illustrate diagrammatic views of wiring configurations for individually pairing emitters with IGBTs, according to some embodiments. Specifically, FIG. 8A illustrates an independent emitter (electrodes 802a and 804a) wired independently, and four emitters (electrodes 802b and 804b, 802c and 804c, 802d and 804d, and 802e and 804e) wired with shared pairs. The generator may control a “high” side (806a, 806b, and 806c) and a “low” side (808a, 808b, and 808c) for each emitter pair. The incoming electrode and outgoing electrode may be selected, or chosen, by the generator in order to control a unique emitter pair. As used herein, an incoming electrode is defined as the electrode that receives a voltage, such as a high voltage, and / or a power line, and an outgoing electrode is a reference ground electrode. Electrodes 802a and 804a form an isolated emitter in this configuration, and thus cannot be a part of an emitter pair, leaving two options for the high side electrode selection (806a and 806b) and two options for the low side electrode selection (808a and 808b), providing four unique combinations of selectable emitter pairs.

[0131] FIG. 8B illustrates five emitter pairs (electrodes 802a and 804a, 802b and 804b, 802c and 804c, 802d and 804d, and 802e and 804e) controlled by five wire electrically coupled tothe generator. Three of these wires (806a, 806b, 806c) control the high side electrode selection. The other two wires (808a, 808b) control the low side electrode selection. The incoming electrode and outgoing electrode may be selected, or chosen, by the generator in order to control a unique emitter pair. The wiring as shown ensures that the activation of a high side wire and low side wire results in a unique combination of selected electrodes and activates only a single emitter pair.

[0132] FIG. 8C also illustrates five emitter pairs (electrodes 802a and 804a, 802b and 804b, 802c and 804c, 802d and 804d, and 802e and 804e) controlled by five wire electrically coupled to the generator. However, in FIG. 8C, two of these wires (806a, 806b) control the high side electrode selection. The other three wires (808a, 808b, 808c) control the low side electrode selection. The incoming electrode and outgoing electrode may be selected, or chosen, by the generator in order to control a unique emitter pair. The wiring as shown ensures that the activation of a high side wire and low side wire results in a unique combination of selected electrodes and activates only a single emitter pair.

[0133]

[0134] Included in the present disclosure is a system, including an elongated body having an inner elongated structure including a guidewire lumen. In some examples, the system includes an emitter positioned along the elongated body, the emitter configured to emit pressure waves to fragment a buildup in an organ, the emitter having a first electrode and a second electrode. According to some examples, the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode. The system may include a generator configured to provide electricity to the emitter. In some examples, the elongated body is configured to couple to the generator, thereby forming an electrical pathway between the generator and the emitter. According to some examples, the system includes a detector configured to detect a parameter along the electrical pathway. The system may be capable of communicating information about the parameter to an operator and / or automatically taking action when the parameter falls outside of a nominal range.

[0135] The forthcoming are example embodiments of the system as described herein.

[0136] The parameter may be a voltage. In some examples, the detector monitors voltage rails along the electrical pathway. According to some examples, the detector monitors a high voltage output. The system may further include a direct current (DC) / DC converter, which may provide the high voltage output.

[0137] In some examples, the voltage is configured to cross the spark gap from the first electrode to the second electrode. According to some examples, the detector is configured todetect if the voltage exceeds a high voltage value. The high voltage value may be indicative of the voltage too high to exceed creepage. In some examples, the high voltage value is indicative of the voltage too high for clearance. According to some examples, the high voltage value is indicative of electrical isolation. The electricity may be prevented from flowing when the voltage exceeds the high voltage value.

[0138] In some examples, the system further includes a delay flip-flop electrically coupled to the electrical pathway, the delay flip-flop configured to perpetually latch when the voltage exceeds the high voltage value. According to some examples, the delay flip-flop interacts with a high voltage rail. In other examples, the delay flip-flop does not interact with the high voltage rail. The high voltage rail may be recoverable, indicating that the only concern is voltage that is in an indefinite state of being too high or too low. In some examples, the delay flip-flops purpose is to latch after a failed current pulse. According to some examples, a perpetually latched delay flip-flop is indicative of a non-recoverable fault state and the non-recoverable fault state is recoverable through a reboot of the system.

[0139] By way of example, the delay flip-flop may come off of a current transformer which translates to a voltage value (i.e., two hundred amperes relates to four volts, or one hundred amperes relates to two volts, etc.). In some examples, the high voltage rail does not directly interact with the delay flip-flop. The high voltage rail may be recoverable, meaning the only necessary information is whether the voltage is too high or too low, indefinitely. According to some examples, the purpose of the delay flip-flop is to latch after a failed current pulse. This description may additionally apply to forthcoming disclosure with respect to the delay flipflop.

[0140] In some examples, the system provides information to a user when the voltage exceeds the high voltage value, the information at least one of permissible and impermissible by the user. The system may be configured to self-test when the voltage exceeds the high voltage value. The system may also be configured to self-test during a rest period.

[0141] According to some examples, a pulse cycle is configured to end immediately when the voltage exceeds the high voltage value. In some examples, the pulse cycle is configured to continue indefinitely for 30 pulses per pulse cycle.

[0142] The system may include a first emitter and a first spark gap as well as a second emitter including a third electrode and a fourth electrode arranged to define a second spark gap between the third and the fourth electrode. In some examples, the detector individually detects the voltage of the first emitter and the second emitter. The system may be configured for electricity to flow to the first emitter and prevented from flowing to the second emitter when the voltageto the second emitter exceeds the high voltage value. In some examples, a number of pulses in a cycle is adjusted when the voltage exceeds the high voltage value. In some examples, a length of a rest period is adjusted when the voltage exceeds the high voltage value. In some examples, the length of the rest period is configured to permit a capacitor to be fully discharged and recharged.

[0143] According to some examples, the voltage exceeding the high voltage value is indicative of a manufacturing defect. In some examples, the manufacturing defect is the first electrode being too close to the second electrode. In some examples, the manufacturing defect is the first electrode being too far from the second electrode.

[0144] According to some examples, the first emitter is a first emitter and the spark gap is a first spark gap, the system further including a second emitter including a third electrode and a fourth electrode arranged to define a second spark gap between the third electrode and the fourth electrode. In some examples, the manufacturing defect is the first emitter being too close to the second emitter. In some examples, the manufacturing defect is the first emitter being too far from the second emitter. According to some examples, the voltage exceeding the high voltage value is indicative of wear and tear on a component of the system.

[0145] The system may include a detector located within the generator, the detector configured to detect if the voltage is less than a low voltage value. In some examples, the low voltage value is indicative of the voltage too low to cross the spark gap. In some examples, the electricity is prevented from flowing when the voltage is less than the low voltage value.

[0146] In some examples, the system further includes a delay flip-flop electrically coupled to the electrical pathway, the delay flip-flop configured to perpetually latch when the voltage is lower than the low voltage value. According to some examples, a perpetually latched delay flip-flop is indicative of a non-recoverable fault state and the non-recoverable fault state is recoverable through a reboot of the system.

[0147] In some examples, the system provides information to a user when the voltage is less than the low voltage value, the information at least one of permissible and impermissible by the user. The system may be configured to self-test when the voltage is less than the low voltage value. The system may also be configured to self-test during a rest period.

[0148] According to some examples, a pulse cycle is configured to end immediately when the voltage is less than the low voltage value. In some examples, the pulse cycle is configured to continue indefinitely. In other examples, the pulse cycle is configured to continue for a course of 30 pulses per pulse cycle.

[0149] The system may include a first emitter and a first spark gap as well as a second emitter including a third electrode and a fourth electrode arranged to define a second spark gap between the third and the fourth electrode. In some examples, the detector individually detects the voltage of the first emitter and the second emitter. The system may be configured for electricity to flow to the first emitter and prevented from flowing to the second emitter when the voltage to the second emitter is less than the high voltage value. In some examples, a number of pulses in a cycle is adjusted when the voltage is less than the low voltage value. In some examples, a length of a rest period is adjusted when the voltage is less than the low voltage value. In some examples, the length of the rest period is configured to permit a capacitor to be fully discharged and recharged.

[0150] According to some examples, the voltage lower than the low voltage value is indicative of a manufacturing defect. In some examples, the manufacturing defect is the first electrode being too close to the second electrode. In some examples, the manufacturing defect is the first electrode being too far from the second electrode.

[0151] According to some examples, the first emitter is a first emitter and the spark gap is a first spark gap, the system further contains a second emitter including a third electrode and a fourth electrode arranged to define a second spark gap between the third electrode and the fourth electrode. In some examples, the manufacturing defect is the first emitter being too close to the second emitter. In some examples, the manufacturing defect is the first emitter being too far from the second emitter. According to some examples, the voltage less than the low voltage value is indicative of wear and tear on a component of the system.

[0152] According to some examples, the generator is configured to prevent the electricity from flowing. In some examples, the system has a microcontroller communicatively coupled to the electrical pathway, the microcontroller configured to prevent the electricity from flowing the voltage is outside of a nominal voltage range.

[0144] The parameter may be a current. In some examples, the detector monitors a current transformer along the electrical pathway and is configured to detect if the current exceeds a high current value. In some examples, the high current value is indicative of a power that is too high, (i.e., where power is defined as work (energy expenditure) over a set time interval, too much work is occurring during said time interval). Stated another way, the power may be defined as the voltage multiplied by the current. Thus, monitoring the voltage and the current may permit a nominal power level to be achieved. In some examples, the electricity is prevented from flowing when the current exceeds the high current value.

[0145] In some examples, the system further includes a delay flip-flop electrically coupled to the electrical pathway, the delay flip-flop configured to perpetually latch when the current exceeds the high current value. According to some examples, a perpetually latched delay flipflop is indicative of a non-recoverable fault state and the non-recoverable fault state is recoverable through a reboot of the system.

[0146] In some examples, the system provides information to a user when the current exceeds the high current value, the information at least one of permissible and impermissible by the user. The system may be configured to self-test when the current exceeds the high current value. The system may also be configured to self-test during a rest period.

[0147] According to some examples, a pulse cycle is configured to end immediately when the current exceeds the high current value. In some examples, the pulse cycle is configured to continue indefinitely. In other examples, the pulse cycle is configured to continue for a course of 30 pulses per pulse cycle.

[0148] The system may include a first emitter and a first spark gap as well as a second emitter including a third electrode and a fourth electrode arranged to define a second spark gap between the third and the fourth electrode. In some examples, the detector individually detects the current of the first emitter and the second emitter. The system may be configured for electricity to flow to the first emitter and prevented from flowing to the second emitter when the current to the second emitter is exceeds the high current value. In some examples, a number of pulses in a cycle is adjusted when the current exceeds the high current value. In some examples, a length of a rest period is adjusted when the current exceeds the high current value. In some examples, the length of the rest period is configured to permit a capacitor to be fully discharged and recharged.

[0149] According to some examples, the current exceeding the high current value is indicative of a manufacturing defect. In some examples, the manufacturing defect is the first electrode being too close to the second electrode. In some examples, the manufacturing defect is the first electrode being too far from the second electrode.

[0150] According to some examples, the first emitter is a first emitter and the spark gap is a first spark gap, the system further contains a second emitter including a third electrode and a fourth electrode arranged to define a second spark gap between the third electrode and the fourth electrode. In some examples, the manufacturing defect is the first emitter being too close to the second emitter. In some examples, the manufacturing defect is the first emitter being too far from the second emitter. According to some examples, the current exceeding the high current value is indicative of wear and tear on a component of the system.

[0151] The system may include a detector located within the generator, wherein the detector is configured to detect if the current is less than a low current value. In some examples, the low current value is indicative of a power too low to deliver a pulse to the emitter. In some examples, the low current value is indicative of a false firing. In some examples, the current less than the low current value informs a user of an issue and the number of pulses in a cycle is adjusted when the current is less than the low current value. In some examples, a length of a rest period is adjusted when the current is less than the low current value. In some examples, the length of the rest period is configured to permit a capacitor to be fully discharged and recharged.

[0152] According to some examples, the current less than the low current value is indicative of a manufacturing defect. In some examples, the manufacturing defect is the first electrode being too close to the second electrode; in others, the manufacturing defect is the first electrode being too far from the second electrode.

[0153] According to some examples, the first emitter is a first emitter and the spark gap is a first spark gap, the system further contains a second emitter including a third electrode and a fourth electrode arranged to define a second spark gap between the third electrode and the fourth electrode. In some examples, the manufacturing defect is the first emitter being too close to the second emitter. In some examples, the manufacturing defect is the first emitter being too far from the second emitter. According to some examples, the current lower than the low current value is indicative of wear and tear on a component of the system.

[0154] The parameter may be an impedance measured at a junction of the electrical pathway and is indicative of a health of the elongated body. In some examples, the detector detects when the impedance is outside of a nominal impedance range. According to some examples, the generator is configured to provide a low-voltage pulse to the emitter, the low-voltage pulse insufficient to cross the spark gap.

[0155] In some examples, the system further includes a delay flip-flop electrically coupled to the electrical pathway, the delay flip-flop configured to perpetually latch when the impedance is outside of the nominal impedance range. According to some examples, a perpetually latched delay flip-flop is indicative of a non-recoverable fault state and the non-recoverable fault state is recoverable through a reboot of the system.

[0156] In some examples, the system provides information to a user when the impedance is outside of the nominal impedance range, the information at least one of permissible and impermissible by the user. The system may be configured to self-test when the impedance is outside of the nominal impedance range. They system may also be configured to self-testduring a rest period. In some examples, a pulse cycle is configured to end immediately when the impedance is outside of the nominal impedance range. In some examples, the pulse cycle is configured to continue indefinitely. In other examples, the pulse cycle is configured to continue for a course of 30 pulses per pulse cycle.

[0157] The system may include a first emitter and a first spark gap as well as a second emitter including a third electrode and a fourth electrode arranged to define a second spark gap between the third and the fourth electrode. In some examples, the detector individually detects the impedance of the first emitter and the second emitter. According to some examples, the generator is configured to prevent electricity from flowing if either of the first emitter and the second emitter is outside of a nominal impedance range. According to some examples, the generator is configured to allow electricity to flow to the first emitter and prevent electricity from flowing to the second emitter when the second emitter is outside of a nominal impedance range. In some examples, a number of pulses in a cycle is adjusted when either of the first emitter and the second emitter is outside of a nominal impedance range. In some examples, a length of a rest period is adjusted when either of the first emitter and the second emitter is outside of a nominal impedance range. In some examples, the length of the rest period is configured to permit a capacitor to be fully discharged and recharged.

[0158] According to some examples, either of the first emitter and the second emitter outside of a nominal impedance range is indicative of a manufacturing defect. In some examples, the manufacturing defect is the first emitter being too close to the second emitter; in others, the manufacturing defect is the first emitter being too far from the second emitter. In some examples, either of the first emitter and the second emitter outside of a nominal impedance range is indicative of wear and tear on a component of the system.

[0159] According to some examples, the detector detects the impedance of the first emitter and the second emitter simultaneously. In some examples, the generator is configured to prevent electricity from flowing if either of the first emitter and the second emitter is outside of a nominal impedance range. In some examples, the generator is configured to allow electricity to flow to the first emitter and prevent electricity from flowing to the second emitter when the second emitter is outside of a nominal impedance range. In some examples, the detector detects the impedance during a rest period of a treatment. In some examples, a number of pulses in a cycle is adjusted when either of the first emitter and the second emitter is outside of a nominal impedance range. In some examples, a length of a rest period is adjusted when either of the first emitter and the second emitter is outside of a nominal impedance range. In some examples,the length of the rest period is configured to permit a capacitor to be fully discharged and recharged.

[0160] According to some examples, either of the first emitter and the second emitter outside of a nominal impedance range is indicative of a manufacturing defect. In some examples, the manufacturing defect is the first emitter being too close to the second emitter; in others, the manufacturing defect is the first emitter being too far from the second emitter. In some examples, either of the first emitter and the second emitter outside of a nominal impedance range is indicative of wear and tear on a component of the system.

[0161] According to some examples, the detector is configured to detect the impedance when the elongated body is coupled to the generator. In some examples, the electrical pathway is a first electrical pathway, the system contains a second electrical pathway. In some examples the detector is configured to detect the impedance along the second electrical pathway. In some examples, the system further contains an analog to digital converter.

[0162] The parameter may be an energy. The system may include the detector located within the generator and measures a power at a plurality of times. In some examples, the energy is determined from a change in the power of the plurality of times. In some examples, the detector is configured to detect if the energy exceeds a high energy value and electricity is prevented from flowing when the energy exceeds the high energy value.

[0163] In some examples, the system further includes a delay flip-flop electrically coupled to the electrical pathway, the delay flip-flop configured to perpetually latch when the energy exceeds the high energy value. According to some examples, a perpetually latched delay flipflop is indicative of a non-recoverable fault state and the non-recoverable fault state is recoverable through a reboot of the system.

[0164] In some examples, the system provides information to a user when the energy exceeds the high energy value, the information at least one of permissible and impermissible by the user. The system may be configured to self-test when the energy exceeds the high energy value. They system may also be configured to self-test during a rest period. In some examples, a pulse cycle is configured to end immediately when the energy exceeds the high energy value. In some examples, the pulse cycle is configured to continue indefinitely. In other examples, the pulse cycle is configured to continue for a course of 30 pulses per pulse cycle.

[0165] The system may include a first emitter and a first spark gap as well as a second emitter including a third electrode and a fourth electrode arranged to define a second spark gap between the third and the fourth electrode. In some examples, the detector individually detects the energy of the first emitter and the second emitter. According to some examples, electricity isconfigured to flow to the first emitter and the electricity is prevented from flowing to the second emitter when the energy to the second emitter exceeds the high energy value. In some examples, a number of pulses in a cycle is adjusted when the energy exceeds the high energy value. In some examples, a length of a rest period is adjusted when the energy exceeds the high energy value. In some examples, the length of the rest period is configured to permit a capacitor to be fully discharged and recharged.

[0166] According to some examples, the energy exceeding the high energy value is indicative of a manufacturing defect. In some examples, the manufacturing defect is the first electrode being too close to the second electrode; in others, the manufacturing defect is the first electrode being too far from the second electrode. In some examples, the manufacturing defect is the first emitter being too close to the second emitter; in others, the manufacturing defect is the first emitter being too far from the second emitter. In some examples, the energy exceeding the high energy value is indicative of wear and tear on a component of the system.

[0167] The parameter may be a temperature. The system may include the detector located within the generator configured to directly and / or indirectly measure the temperature. The system may include a thermocouple configured to measure the temperature. In some examples, the detector further includes a thermocouple. In some examples, the temperature is used to calculate a power output and the detector is configured to detect if the power output exceeds a high power output value and electricity is prevented from flowing when the power output exceeds the high power output value.

[0168] In some examples, the system further includes a delay flip-flop electrically coupled to the electrical pathway, the delay flip-flop configured to perpetually latch when the power output exceeds the high power output value. According to some examples, a perpetually latched delay flip-flop is indicative of a non-recoverable fault state and the non-recoverable fault state is recoverable through a reboot of the system.

[0169] In some examples, the system provides information to a user when the power output exceeds the high power output value, the information at least one of permissible and impermissible by the user. The system may be configured to self-test when the power output exceeds the high power output value. The system may also be configured to self-test during a rest period. In some examples, a pulse cycle is configured to end immediately when the power output exceeds the high power output value. In some examples, the pulse cycle is configured to continue indefinitely. In other examples, the pulse cycle is configured to continue for a course of 30 pulses per pulse cycle.

[0170] The system may include a first emitter and a first spark gap as well as a second emitter including a third electrode and a fourth electrode arranged to define a second spark gap between the third and the fourth electrode. In some examples, the detector individually detects the power output of the first emitter and the second emitter. According to some examples, electricity is configured to flow to the first emitter and the electricity is prevented from flowing to the second emitter when the power output to the second emitter exceeds the high power output value. In some examples, a number of pulses in a cycle is adjusted when the power output exceeds the high power output value. In some examples, a length of a rest period is adjusted when the power output exceeds the high power output value. In some examples, the length of the rest period is configured to permit a capacitor to be fully discharged and recharged.

[0171] According to some examples, the power output exceeding the high power output value is indicative of a manufacturing defect. In some examples, the manufacturing defect is the first electrode being too close to the second electrode; in others, the manufacturing defect is the first electrode being too far from the second electrode.

[0172] The system may include a first emitter and a first spark gap as well as a second emitter including a third electrode and a fourth electrode arranged to define a second spark gap between the third and the fourth electrode. In some examples, the manufacturing defect is the first emitter being too close to the second emitter; in others, the manufacturing defect is the first emitter being too far from the second emitter. In some examples, the power output exceeding the high power output value is indicative of wear and tear on a component of the system.

[0173] The parameter may be an internal load. The system may include the detector located within the generator, the generator configured to deliver a pulse confined within the generator. The system may include a relay separate from the electrical pathway, the relay configured to deliver the pulse to the internal load. In some examples, the internal load is configured to represent a nominal load of the emitter. In some examples, the electricity is prevented from flowing when the pulse is outside of the nominal load.

[0174] In some examples, the system further includes a delay flip-flop electrically coupled to the electrical pathway, the delay flip-flop configured to perpetually latch when the pulse is outside of the nominal load. According to some examples, a perpetually latched delay flip-flop is indicative of a non-recoverable fault state and the non-recoverable fault state is recoverable through a reboot of the system.

[0175] In some examples, the system provides information to a user when the pulse is outside of the nominal load, the information at least one of permissible and impermissible by the user. The system may be configured to self-test when the pulse is outside of the nominal load. Thesystem may also be configured to self-test during a rest period. In some examples, a pulse cycle is configured to end immediately when the pulse is outside of the nominal load. In some examples, the pulse cycle is configured to continue indefinitely. In other examples, the pulse cycle is configured to continue for a course of 30 pulses per pulse cycle.

[0176] According to some examples, a number of pulses in a cycle is adjusted when the pulse is outside of the nominal load. In some examples, a length of a rest period is adjusted when the pulse is outside of the nominal load. In some examples, the length of the rest period is configured to permit a capacitor to be fully discharged and recharged.

[0177] According to some examples, the pulse outside of the nominal load is indicative of a manufacturing defect. In some examples, the manufacturing defect is the first electrode being too close to the second electrode; in others, the manufacturing defect is the first electrode being too far from the second electrode.

[0178] The system may include a first emitter and a first spark gap as well as a second emitter including a third electrode and a fourth electrode arranged to define a second spark gap between the third and the fourth electrode. In some examples, the manufacturing defect is the first emitter being too close to the second emitter; in others, the manufacturing defect is the first emitter being too far from the second emitter. In some examples, the pulse outside of the nominal load is indicative of wear and tear on a component of the system.

[0179] The parameter may be a pulse duration. The system may include the detector located within the generator. The parameter may be a voltage recovery time. The system may be configured so the voltage recovery time is indicative of a time until a capacitor is fully charged. In some examples, the voltage recovery time is configured to indicate a direct current (DC) / DC returning to an original time period.

[0180] In some examples, the voltage recovery time is configured to indicate that an insulated- gate bipolar transistor (IBGT) is fully opening or fully closing. In some examples, the voltage recovery time is configured to indicate that a pulse is occurring. In some examples, the voltage recovery time is configured to indicate an acceptable health of the elongated body. According to some examples, the detector is configured to determine if the voltage recovery time falls within a nominal voltage recovery time range.

[0181] In some examples, the system further includes a delay flip-flop electrically coupled to the electrical pathway, the delay flip-flop configured to perpetually latch when the voltage recovery time is outside of the nominal voltage recovery time range. According to some examples, a perpetually latched delay flip-flop is indicative of a non-recoverable fault state and the non-recoverable fault state is recoverable through a reboot of the system.

[0182] In some examples, the system provides information to a user when the voltage recovery time falls within the nominal voltage recovery time range, the information at least one of permissible and impermissible by the user. The system may be configured to self-test when the voltage recovery time falls within the nominal voltage recovery time range. They system may also be configured to self-test during a rest period. In some examples, a pulse cycle is configured to end immediately when the voltage recovery time falls within the nominal voltage recovery time range. In some examples, the pulse cycle is configured to continue indefinitely. In other examples, the pulse cycle is configured to continue for a course of 30 pulses per pulse cycle.

[0183] According to some examples, the voltage recovery time falling outside of the nominal voltage recovery time range indicates a need for maintenance. In some examples, the voltage recovery time falling outside of the nominal voltage recovery time range indicates a need for a retirement of the elongated body.

[0184] According to some examples, a number of pulses in a cycle is adjusted when the voltage recovery time falls outside of the nominal voltage recovery time range. In some examples, a length of a rest period is adjusted when the voltage recovery time falls outside of the nominal voltage recovery time range. In some examples, the length of the rest period is configured to permit a capacitor to be fully discharged and recharged.

[0185] According to some examples, the voltage recovery time falling outside of the nominal voltage recovery time range is indicative of a manufacturing defect. In some examples, the manufacturing defect is the first electrode being too close to the second electrode; in others, the manufacturing defect is the first electrode being too far from the second electrode.

[0186] The system may include a first emitter and a first spark gap as well as a second emitter including a third electrode and a fourth electrode arranged to define a second spark gap between the third and the fourth electrode. In some examples, the manufacturing defect is the first emitter being too close to the second emitter; in others, the manufacturing defect is the first emitter being too far from the second emitter. In some examples, voltage recovery time falling outside of the nominal voltage recovery time range is indicative of wear and tear on a component of the system.

[0187] The system may include the detector located within the generator. The system may further contain a PROM housed within the catheter and configured to receive information relating to any parameter described herein, which may be obtained via any detector described herein. In some examples, the PROM retains a minimum and maximum datum for the parameter. In some examples, the PROM retains a calibration datum. According to someexamples, the detector monitors the parameter to determine a detected value and compares the detected value with the calibration datum.

[0188] The parameter may be a pulse count. In some examples, the pulse count begins from an initial value and decrements to a final value. According to some examples, the system is inoperable when the pulse count reaches the final value. In some examples, the system further includes a delay flip-flop electrically coupled to the electrical pathway, the delay flip-flop configured to perpetually latch when the pulse count reaches the final value. According to some examples, a perpetually latched delay flip-flop is indicative of a non-recoverable fault state. In some examples, the system provides information to a user when the pulse count reaches the final value. In some examples, a pulse cycle is configured to end immediately when the pulse count reaches the final value.

[0189] According to some examples, the PROM is extracted for harvesting and analyzing a datum of the parameter once the elongated body is no longer usable. In some examples, the elongated body includes a proximal elongated end and a distal elongated end opposite the proximal elongated end and a fluid pathway extending therethrough. The system may further include an expandable member located near the distal elongated end, the expandable member configured to receive a fluid through the pathway.

[0190] The parameter may be a pressure. In some examples, the detector is configured to detect if the pressure is less than a low-pressure value and electricity is prevented from flowing when the pressure is less than the low-pressure value. In some examples, the system further includes a delay flip-flop electrically coupled to the electrical pathway, the delay flip-flop configured to perpetually latch when the pressure is less than the low-pressure value. According to some examples, a perpetually latched delay flip-flop is indicative of a non-recoverable fault state and the non-recoverable fault state is recoverable through a reboot of the system.

[0191] In some examples, the system provides information to a user when the pressure is less than the low-pressure value, the information at least one of permissible and impermissible by the user. In some examples, a pulse cycle is configured to end immediately when the pressure is less than the low-pressure value. In some examples, the pulse cycle is configured to continue indefinitely. In other examples, the pulse cycle is configured to continue for a course of 30 pulses per pulse cycle.

[0192] According to some examples, the pressure less than the low-pressure value is indicative of a manufacturing defect. In some examples, the pressure less than the low-pressure value is indicative of wear and tear on the system.

[0193] The system may include the detector located within the generator. The system may include the detector located within the fluid pathway. The system may further include a first capacitor housed within the generator, the first capacitor configured to deliver the electricity to the emitter; the bank size of and power draw from the first capacitor is based upon the parameter. The system may further include a second capacitor. In some examples, the first capacitor pulses at a first pulse rate and the second capacitor pulses at a second pulse rate, the respective pulse rates being different. According to some examples, the first capacitor defines a first volume and the second capacitor defines a second volume, the respective volumes being different. According to some examples, the first capacitor includes a first bank capacity and the second capacitor includes a second bank capacity, the respective bank capacities being different.

[0194] None of the steps described herein is essential or indispensable. Any of the steps can be adjusted or modified. Other or additional steps can be used. Any portion of any of the steps, processes, structures, and / or devices disclosed or illustrated in one embodiment, flowchart, or example in this specification can be combined or used with or instead of any other portion of any of the steps, processes, structures, and / or devices disclosed or illustrated in a different embodiment, flowchart, or example. The embodiments and examples provided herein are not intended to be discrete and separate from each other.

[0195] The section headings and subheadings provided herein are nonlimiting. The section headings and subheadings do not represent or limit the full scope of the embodiments described in the sections to which the headings and subheadings pertain. For example, a section titled “Topic 1” may include embodiments that do not pertain to Topic 1, and embodiments described in other sections may apply to and be combined with embodiments described within the “Topic 1” section.

[0196] To increase the clarity of various features, other features are not labeled in each figure.

[0197] The various features and processes described above may be used independently of one another or may be combined in various ways. All possible combinations and subcombinations are intended to fall within the scope of this disclosure. In addition, certain method, event, state, or process blocks may be omitted in some implementations. The methods, steps, and processes described herein are also not limited to any particular sequence, and the blocks, steps, or states relating thereto can be performed in other sequences that are appropriate. For example, described tasks or events may be performed in an order other than the order specifically disclosed. Multiple steps may be combined in a single block or state. The example tasks or events may be performed in serial, parallel, or some other manner. Tasks or events may beadded to or removed from the disclosed example embodiments. The example systems and components described herein may be configured differently than described. For example, elements may be added to, removed from, or rearranged compared to the disclosed example embodiments.

[0198] Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless expressly stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and / or steps. Thus, such conditional language is not generally intended to imply that features, elements, and / or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and / or steps are included or are to be performed in any particular embodiment. The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless expressly stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y, and at least one of Z to each be present.

[0199] The term “and / or” means that “and” applies to some embodiments and “or” applies to some embodiments. Thus, A, B, and / or C can be replaced with A, B, and C written in one sentence and A, B, or C written in another sentence. A, B, and / or C means that some embodiments can include A and B, some embodiments can include A and C, some embodiments can include B and C, some embodiments can only include A, some embodiments can include only B, some embodiments can include only C, and some embodiments can include A, B, and C. The term “and / or” is used to avoid unnecessary redundancy.

[0200] While certain example embodiments have been described, these embodiments have been presented by way of example only and are not intended to limit the scope of the inventions disclosed herein. Thus, nothing in the foregoing description implies that any particular feature, characteristic, step, module, or block is necessary or indispensable. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms; furthermore,various omissions, substitutions, and changes in the form of the methods and systems described herein may be made without departing from the spirit of the inventions disclosed herein.

Claims

We Claim:

1. A system, comprising: an elongated body comprising a guidewire lumen; a pressure wave emitter disposed about the elongated body and comprising a first electrode and a second electrode, wherein the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode, and wherein the first electrode is configured to transmit electricity across the spark gap to the second electrode to cause a spark, such that the spark is configured to enable a pressure wave to be generated; a generator configured to couple to the pressure wave emitter and deliver the electricity thereto via an electrical pathway; and a detector configured to detect an aspect of i) the electricity along the electrical pathway, ii) an aspect of the pressure wave emitter, iii) an aspect of the generator, or iv) combinations thereof.

2. The system of Claim 1, wherein the elongated body comprises an inner elongated structure, the inner elongated structure comprising the guidewire lumen.

3. The system of Claim 1 or 2, wherein the pressure wave emitter is positioned along a central longitudinal axis of the elongated body.

4. The system of any of Claims 1-3, wherein the aspect is a voltage.

5. The system of Claim 4, wherein the detector is configured to monitor voltage rails along the electrical pathway.

6. The system of Claim 4, wherein the detector is configured to monitor a high voltage output.

7. The system of Claim 6, further comprising a direct current (DC) / DC converter, wherein the DC / DC converter provides the high voltage output.

8. The system of any of Claims 4-7, wherein the detector is configured to detect if the voltage i) exceeds a high voltage value, ii) is less than a low voltage value, or iii) combinations thereof.

9. The system of Claim 8, wherein the high voltage value is indicative of i) voltage too high to exceed creepage, ii) voltage too high for clearance, iii) electrical isolation, or iv) combinations thereof.

10. The system of Claim 8 or 9, wherein the low voltage value is indicative of voltage too low to cross the spark gap.

11. The system of any of Claims 1-10, wherein the aspect is a current.

12. The system of Claim 11, wherein the detector is configured to monitor a current transformer along the electrical pathway.

13. The system of Claim 11 or 12, wherein the detector is configured to detect if the current i) exceeds a high current value, ii) is lower than a low current value, or iii) combinations thereof.

14. The system of Claim 13, wherein the high current value is indicative of a power that is too high.

15. The system of Claim 13 or 14, wherein the low current value is indicative of i) a power that is too low to deliver a pulse to the emitter, ii) a false firing, or iii) combinations thereof.

16. The system of Claims 1-15, wherein the aspect is an impedance.

17. The system of Claim 16, wherein the generator is configured to provide a low-voltage pulse to the pressure wave emitter.

18. The system of Claim 17, wherein the low-voltage pulse is insufficient to cross the spark gap-19. The system of any of Claims 16-18, wherein the impedance is measured at a junction of the electrical pathway.

20. The system of any of Claims 16-19, wherein the impedance is indicative of a health of the elongated body.

21. The system of any of Claims 16-20, wherein the detector is configured to detect when the impedance is outside of a nominal impedance range.

22. The system of any of Claims 1-21, wherein the aspect is an internal load.

23. The system of Claim 22, wherein the generator is configured to deliver a pulse.

24. The system of Claim 23, wherein the pulse is confined within the generator.

25. The system of Claim 23 or 24, further comprising a relay electrically isolated from the electrical pathway.

26. The system of Claim 25, wherein the relay is configured to deliver the pulse to the internal load.

27. The system of any of Claims 22-26, wherein the internal load is configured to represent a nominal load of the pressure wave emitter.

28. The system of any of Claims 22-27, wherein the electricity is prevented from flowing when the pulse is outside of the nominal load.

29. The system of any of Claims 8-28 wherein the electricity is prevented from flowing when i) the voltage exceeds the high voltage value, ii) the voltage is lower than the low voltage value, iii) the current exceeds the high current value, iv) the current is lower than the low current value, v) the impedance is outside of the nominal impedance range, vi) the pulse is outside of the nominal load, or vii) combinations thereof.

30. The system of any of Claims 8-28, further comprising a delay flip-flop electrically coupled to the electrical pathway, wherein the delay flip-flop is configured to perpetually latch when i) the voltage exceeds the high voltage value, ii) the voltage is lower than the low voltage value, iii) the current exceeds the high current value, iv) the current is lower than the low current value, v) the impedance is outside of the nominal impedance range, vi) the pulse is outside of the nominal load, or vii) combinations thereof.

31. The system of Claim 30, wherein a perpetually latched delay flip-flop is indicative of a non-recoverable fault state.

32. The system of Claim 31, wherein the non-recoverable fault state is recoverable through a reboot of the system.

33. The system of any of Claims 8-32, further comprising an insulated-gate bipolar transistor (IGBT) electrically coupled to the electrical pathway, wherein the IGBT is configured to open and thereby electrically isolate the pressure wave emitter from the electrical pathway when i) the voltage exceeds the high voltage value, ii) the voltage is lower than the low voltage value, iii) the current exceeds the high current value, iv) the current is lower than the low current value, v) the impedance is outside of the nominal impedance range, vi) the pulse is outside of the nominal load, or vii) combinations thereof.

34. The system of any of Claims 8-33, wherein the system provides information to a user when i) the voltage exceeds the high voltage value, ii) the voltage is lower than the low voltage value, iii) the current exceeds the high current value, iv) the current is lower than the low current value, v) the impedance is outside of the nominal impedance range, vi) the pulse is outside of the nominal load, or vii) combinations thereof.

35. The system of Claim 34, wherein the information is i) permissible or ii) impermissible by the user.

36. The system of any of Claims 8-35, wherein the system is configured to self-test i) when the voltage exceeds the high voltage value, ii) when the voltage is lower than the low voltage value, iii) the current exceeds the high current value, iv) the current is lower than the low current value, v) the impedance is outside of the nominal impedance range, vi) the pulse is outside of the nominal load, vii) during a rest period, or viii) combinations thereof.

37. The system of any of Claims 8-36, wherein a pulse cycle is configured to end immediately when i) the voltage exceeds the high voltage value, ii) the voltage is lower than the low voltage value, iii) the current exceeds the high current value, iv) the current is lower than the low current value, v) the impedance is outside of the nominal impedance range, vi) the pulse is outside of the nominal load, or vii) combinations thereof.

38. The system of Claim 37, wherein the pulse cycle is configured to continue indefinitely.

39. The system of any of Claims 8-38, wherein a number of pulses in a cycle is adjusted when i) the voltage exceeds the high voltage value, ii) the voltage is lower than the low voltage value, iii) the current exceeds the high current value, iv) the current is lower than the low current value, v) the impedance is outside of the nominal impedance range, vi) the pulse is outside of the nominal load, or vii) combinations thereof.

40. The system of any of Claims 8-39, wherein a length of a rest period is adjusted when i) the voltage exceeds the high voltage value, ii) the voltage is lower than the low voltage value, iii) the current exceeds the high current value, iv) the current is lower than the low current value, v) the impedance is outside of the nominal impedance range, vi) the pulse is outside of the nominal load, or vii) combinations thereof.

41. The system of Claim 40, wherein the length of the rest period is configured to permit a capacitor to be fully discharged and recharged.

42. The system of any of Claims 8-41, wherein i) the voltage exceeding the high voltage value, ii) the voltage falling lower than the low voltage value, iii) the current exceeding the high current value, iv) the current falling lower than the low current value, v) the impedance falling outside of the nominal impedance range, vi) the pulse falling outside of the nominal load, or vii) combinations thereof is indicative of a manufacturing defect.

43. The system of Claim 42, wherein the manufacturing defect is the first electrode being i) too close to the second electrode or ii) too far from the second electrode.

44. The system of any of Claims 8-43, wherein i) the voltage exceeding the high voltage value, ii) the voltage falling lower than the low voltage value, iii) the current exceeding the high current value, iv) the current falling lower than the low current value, v) the impedance falling outside of the nominal impedance range, vi) the pulse falling outside of the nominal load, or vii) combinations thereof is indicative of wear and tear on a component of the system.

45. The system of any of Claims 8-44, wherein the pressure wave emitter is a first pressure wave emitter and the spark gap is a first spark gap, the system further comprising a second pressure wave emitter comprising a third electrode and a fourth electrode arranged to define a second spark gap between the third electrode and the fourth electrode,wherein the detector is configured to individually detect i) the voltage, ii) the current, iii) the impedance, iv) the internal load, or v) combinations thereof of the first pressure wave emitter and the second pressure wave emitter.

46. The system of Claim 45, wherein the manufacturing defect is the first pressure wave emitter being i) too close to the second pressure wave emitter or ii) too far from the second pressure wave emitter.

47. The system of any of Claims 1-46, wherein the detector is located within the generator.

48. The system of any of Claims 1-47, wherein the generator is configured to prevent the electricity from flowing.

49. The system of any of Claims 1-48, further comprising a microcontroller communicatively coupled to the electrical pathway.

50. The system of Claim 49, wherein the microcontroller is configured to prevent the electricity from flowing when the voltage is outside of a nominal voltage range.

51. A system, comprising: an elongated body comprising a guidewire lumen; a balloon positioned at a first end of the elongated body, the balloon configured to receive an inflation fluid to inflate the balloon; an inflation lumen extending from a second end of the elongated body into the balloon, thereby forming a fluid pathway therebetween; a pressure wave emitter disposed about the elongated body and comprising a first electrode and a second electrode, wherein the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode, and wherein the first electrode is configured to transmit electricity across the spark gap to the second electrode to cause a spark, such that the spark is configured to enable a pressure wave to be generated; a generator configured to couple to the pressure wave emitter and deliver the electricity thereto via an electrical pathway; anda detector configured to detect an aspect of i) the inflation fluid along the fluid pathway, ii) the balloon, or iii) combinations thereof.

52. The system of Claim 51, wherein the elongated body comprises an inner elongated structure, the inner elongated structure comprising the guidewire lumen.

53. The system of Claim 51 or 52, wherein the pressure wave emitter is positioned along a central longitudinal axis of the elongated body.

54. The system of any of Claims 51-53, wherein the aspect of the balloon is a balloon pressure.

55. The system of Claim 54, wherein the detector comprises a pressure sensor configured to measure the balloon pressure.

56. The system of Claim 55, wherein the pressure sensor is located along the fluid pathway.

57. The system of Claim 55, further comprising i) a handle, ii) a hub, or iii) a sled, i) the handle, ii) the hub, or iii) the sled coupled to one or more of the generator and the elongated body, wherein the pressure sensor is disposed on or about i) the handle, ii) the hub, or iii) the sled.

58. The system of any of Claims 51-57, wherein the detector is configured to detect an external temperature or a temperature relating to the system.

59. The system of Claim 58, wherein the external temperature is indicative of an ambient temperature.

60. The system of Claim 58 or 59, wherein the detector comprises a thermocouple, a resistance temperature detector (RTD), a thermistor, or any combination thereof, each configured to measure the external temperature.

61. The system of Claim 60, wherein the detector comprises the thermocouple, the thermocouple being disposed on an interior surface of the balloon, on an exterior surface of the balloon, or within the balloon.

62. The system of any of Claims 51-61, wherein the aspect of the inflation fluid is a temperature of the inflation fluid.

63. The system of Claim 62, wherein the detector comprises an infrared sensor configured to measure the temperature of the inflation fluid, corresponding to the external temperature.

64. The system of Claim 63, wherein the balloon comprises the infrared sensor.

65. The system of any of Claims 62-64, wherein the detector comprises an infrared sensor configured to measure the temperature of the inflation lumen.

66. A system, comprising: an elongated body comprising a guidewire lumen; a pressure wave emitter disposed about the elongated body and comprising a first electrode and a second electrode, wherein the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode, and wherein the first electrode is configured to transmit electricity across the spark gap to the second electrode to cause a spark, such that the spark is configured to enable a pressure wave to be generated; a generator configured to couple to the emitter and deliver the electricity thereto via an electrical pathway; an optical fiber extending at least partially along a length of the elongated body, the optical fiber defining an optical pathway; and a detector configured to detect an aspect of i) the spark, ii) the pressure wave, or iii) both.

67. The system of Claim 66, wherein the elongated body comprises an inner elongated structure, the inner elongated structure comprising the guidewire lumen.

68. The system of Claim 66 or 67, wherein the pressure wave emitter is positioned along a central longitudinal axis of the elongated body.

69. The system of any of Claims 66-68, wherein the aspect of the pressure wave is an ultrasound intensity.

70. The system of Claim 69, wherein the ultrasound intensity is indicative of a pressure of each pulse associated with the pressure wave.

71. The system of Claim 70, wherein the detector comprises a hydrophone configured to measure i) the ultrasound intensity, ii) a refractive index change as a function of time, or iii) both.

72. The system of Claim 70 or 71, wherein measuring the ultrasound intensity provides a feedback on whether the pressure wave being generated is appropriate for a treatment.

73. A system, comprising: an elongated body comprising a guidewire lumen; a pressure wave emitter disposed about the elongated body and comprising a first electrode and a second electrode, wherein the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode, and wherein the first electrode is configured to transmit electricity across the spark gap to the second electrode to cause a spark, such that the spark is configured to enable a pressure wave to be generated; a generator configured to couple to the emitter and deliver the electricity thereto via an electrical pathway; and a detector configured to determine a humidity of an ambient environment i) about the system, ii) within the generator, or iii) both.

74. The system of Claim 73, wherein the detector comprises a hygrometer configured to measure the humidity.

75. A system, comprising: an elongated body comprising a guidewire lumen; a pressure wave emitter disposed about the elongated body and comprising a first electrode and a second electrode, wherein the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode, andwherein the first electrode is configured to transmit electricity across the spark gap to the second electrode to cause a spark, such that the spark is configured to enable a pressure wave to be generated; a generator configured to couple to the emitter and deliver the electricity thereto via an electrical pathway; and a detector configured to determine an elastic modulus of a vessel wall within a subject.

76. The system of Claim 75, wherein the detector is further configured to perform an intravascular ultrasound (IVUS) configured to map a treatment segment, so as to map a calcified lesion on the vessel wall.

77. The system of Claim 75 or 76, further comprising: a first imaging electrode proximal to the pressure wave emitter; and a second imaging electrode distal to the pressure wave emitter, wherein the first imaging electrode and the second imaging electrode are configured to map the treatment segment.

78. The system of any of Claims 75-77, further comprising a camera at a distal end of the elongated body configured to map a calcified lesion.

79. The system of any of Claims 75-78, wherein the generator is configured to deliver an amount of electricity to the pressure wave emitter based on the mapped treatment segment.

80. The system of any of Claims 75-79, wherein the pressure wave emitter is a first pressure wave emitter and the spark gap is a first spark gap, the system further comprising a second pressure wave emitter comprising a third electrode and a fourth electrode arranged to define a second spark gap between the third electrode and the fourth electrode, and wherein the generator is configured to deliver electricity to the first pressure wave emitter and the second pressure wave emitter in a sequence based on the mapped treatment segment.

81. The system of any of Claim 75-80, wherein the pressure wave emitter is a first pressure wave emitter and the spark gap is a first spark gap, the system further comprising a secondpressure wave emitter comprising a third electrode and a fourth electrode arranged to define a second spark gap between the third electrode and the fourth electrode, and wherein the generator is configured to deliver a different amount of electricity to the first pressure wave emitter and the second pressure wave emitter based on the mapped treatment segment.

82. A system, comprising: an elongated body comprising a guidewire lumen; a pressure wave emitter disposed about the elongated body and comprising a first electrode and a second electrode, wherein the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode, and wherein the first electrode is configured to transmit electricity across the spark gap to the second electrode to cause a spark, such that the spark is configured to enable a pressure wave to be generated; a generator configured to couple to the emitter and deliver the electricity thereto via an electrical pathway; and a detector configured to determine a maximum acceleration experienced by the generator, the elongated body, the detector, the pressure wave emitter, or any combination thereof.

83. The system of Claim 82, wherein the detector comprises a gravity-force sensor, an accelerometer, or both.

84. A system, comprising: an elongated body comprising a guidewire lumen; a balloon positioned at a first end of the elongated body, the balloon configured to receive a fluid to inflate the balloon; an inflation lumen extending from a second end of the elongated body into the balloon, thereby forming a fluid pathway therebetween; a pressure wave emitter disposed about the elongated body and comprising a first electrode and a second electrode, wherein the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode, andwherein the first electrode is configured to transmit electricity across the spark gap to the second electrode to cause a spark, such that the spark is configured to enable a pressure wave to be generated; a generator configured to couple to the emitter and deliver the electricity thereto via an electrical pathway; and a detector configured to determine a bubble formation within the fluid.

85. The system of Claim 84, wherein the bubble formation is indicative of an increased amount of gas in the fluid.

86. The system of Claim 84 or 85, wherein the detector comprises i) an x-ray device configured to measure the bubble formation, ii) an optical fiber configured to measure the bubble formation, or iii) both.

87. The system of any of Claims 84-86, wherein the detector comprises an array of photodiodes configured to detect light, thereby enabling detection of the bubble formation.

88. The system of Claim 87, wherein the array of photodiodes is configured to receive a back reflection from a distal end of an optical fiber.

89. The system of Claim 88, wherein the back reflection from the distal end of the optical fiber comprises a Fresnel reflection.

90. The system of any of Claims 84-89, wherein the detector comprises an ultrasound device configured to measure an ultrasound intensity, and wherein the ultrasound intensity is indicative of the bubble formation.

91. The system of Claim 90, wherein the ultrasound intensity is indicative of a pressure of each pulse of the pressure wave.

92. The system of Claim 90 or 91 , wherein the detector comprises a hydrophone configured to measure the ultrasound intensity, such that a change thereof is indicative of the bubble formation.

93. A system, comprising: an elongated body comprising a guidewire lumen;a pressure wave emitter disposed about the elongated body and comprising a first electrode and a second electrode, wherein the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode, and wherein the first electrode is configured to transmit electricity across the spark gap to the second electrode to cause a spark, such that the spark is configured to enable a pressure wave to be generated; a generator configured to couple to the emitter and deliver the electricity thereto via an electrical pathway; a first detector of any detector of Claims 1-92; and a second detector of any detector of Claims 1-92, wherein the first detector is different from the second detector.

94. A system, comprising: an elongated body comprising a guidewire lumen; a balloon positioned at a first end of the elongated body, the balloon configured to receive a fluid to inflate the balloon; an inflation lumen extending from a second end of the elongated body into the balloon, thereby forming a fluid pathway therebetween; a pressure wave emitter disposed about the elongated body and comprising a first electrode and a second electrode, wherein the first electrode and the second electrode are arranged to define a spark gap between the first electrode and the second electrode, and wherein the first electrode is configured to transmit electricity across the spark gap to the second electrode to cause a spark, such that the spark is configured to enable a pressure wave to be generated; a generator configured to couple to the emitter and deliver the electricity thereto via an electrical pathway; a first detector of any detector of Claims 1-92; and a second detector of any detector of Claims 1-92, wherein the first detector is different from the second detector.

95. The system of any of Claims 1-94, wherein the detector is in communication with a processor configured to output a respective detection by the detector.

96. The system of Claim 95, wherein the output comprises a visual output depicted on a display that is in communication with the processor, an audio output, a communication sent to an interested party, an automatic shutdown of one or more components of the system, or any combination thereof.

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