Intravascular lithotripsy devices and systems including sizing measurements

Abstract

Systems and methods for performing an intravascular lithotripsy (IVL) procedure and a sizing procedure within a vasculature of a subject. A system may include a catheter having a distal end provided with an inflatable balloon and a plurality of electrodes within the balloon, where at least one first electrode is provided as a component of a first emitter and electrically connected to both a high voltage pulse generator for performing IVL operations and a conductive excitation module for performing sizing operations. A method may include energizing a first electrode and sensing conductance or admittance at a second electrode for performing a sizing operation within a balloon positioned in a vasculature of a subject; and generating a spark between the first electrode provided as one electrode part of the first emitter electrode pair and the other electrode part of the first emitter electrode pair by providing a high-voltage pulse from the high-voltage pulse generator for performing an IVL operation.

Description

[0001] Cross-references to related applications

[0002] This application claims priority and benefit to U.S. Provisional Patent Application US63 / 461,085, filed April 21, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This invention relates to a catheter system that utilizes energy waves generated by electrodes within a conductive fluid medium to treat vascular thrombosis or calcification. Background Technology

[0004] Catheter systems equipped with angioplasty balloons are often used to apply physical force by pushing the balloon against the expansion of calcified lesions within the vascular system, thereby forcing the calcification back into and against the vessel wall. Some such calcified lesions and thrombi cannot be effectively broken up by using angioplasty balloons alone.

[0005] Recently, catheter systems have been developed that include a balloon similar to an angioplasty balloon, filled with a conductive liquid medium such as saline solution, for inflating the balloon to the appropriate position at the lesion or thrombus. The catheter system includes one or more pairs of electrodes operatively positioned within the conductive liquid medium. A high-voltage direct current is used to apply pulses to the electrodes to generate sparks that skip across the gap between the two electrodes with each pulse. The sparks within the conductive medium generate energy waves that propagate through the liquid medium, causing the balloon to physically exert a force on the lesion or thrombus. This energy propagation includes the generation of microbubbles, which also contribute to the physical force. Such devices are known to provide energy waves to act on lesions or thrombi with the aim of breaking up calcifications or clumps.

[0006] Current catheter systems include treatment sequences comprising a maximum number of consecutive pulses, followed by a minimum delay and a hard maximum total pulse associated with a specific catheter. One such product specifies:

[0007]

[0008] If treatment is not completed after the maximum total pulse count per catheter, the physician must replace the catheter, accompanied by undesirable consequences, costs, delays, and disruptions.

[0009] Intravascular lithotripsy (IVL) devices are available for some calcification patterns. Disposable IVL balloon devices are offered in different designs and sizes for peripheral or coronary indications. All designs utilize reusable power sources, such as IVL generators. A reusable DC generator is available in the following specifications:

[0010]

[0011] One such disposable device consists of a 0.014 inch guidewire compatible, fluid-filled balloon angioplasty catheter with two lithotripsy emitters incorporated into the shaft of a 12 mm long balloon segment. The fluid-filled balloon (e.g., 50 / 50 saline contrast) is inflated to about 4 atm (atmospheres), and then the emitters are provided with an electrical pulse, which generates a high voltage spark to provide therapy. Sound waves are generated, and the calcifications are broken up.

[0012] Known sizing balloons utilize electrical conductance to measure the size of a portion of a patient's vasculature, particularly for determining the proper stent size to be implanted. Figure 1 A known sizing balloon is shown in FIG. 1. In this example, inflated balloon A is shown filled with saline and positioned at the distal end of catheter C. Four electrodes (El, E2, E3, and E4) are disposed at a controlled spacing along the catheter within the balloon. For DC connections, a positive voltage in the order of tens of volts or lower is provided to electrodes El and E4, and the conductance is measured at electrodes E2 and E3, which are connected to a negative voltage. For AC connections, the hot side is provided to electrodes El and E4, and electrodes E2 and E3 are connected to the neutral. The conductivity is determined based on the ratio of current / voltage drop, which is directly related to the balloon cross-sectional area by Ohm's law. For the measurement, the two outer electrodes El and E4 are excited, while the two inner electrodes E2 and E3 sense and measure the voltage signal. The system can be excited with AC and / or DC electricity for determining the difference between the liquid and the tissue. For more details on such sizing balloons and sizing, see the paper by Svendsen et al., entitled "Conductance sizing balloon for measurement of peripheral artery minimal stent area," published in the Journal of Vascular Surgery, September 2014, which is incorporated by reference in its entirety.

[0013] This paper describes a method of using a conductance sizing balloon (CSB) to accurately measure the minimum stent area (MSA) in peripheral arteries. The CSB measures the electrical conductivity of the artery to determine its diameter and thus the MSA. The CSB is compared to other methods for measuring MSA in peripheral arteries, such as intravascular ultrasound and angiography, both of which have limitations and can not provide accurate measurements. In comparison to these methods, the CSB has several advantages, including its ability to measure MSA in real-time and without the need for contrast agents. The paper discusses a study that evaluated the performance of the CSB in measuring MSA in peripheral arteries. They found that the CSB provided accurate and reliable MSA measurements with a correlation coefficient of 0.96 compared to intravascular ultrasound measurements. SUMMARY

[0014] According to an aspect of the present invention, a system for performing both intravascular lithotripsy (IVL) operation and sizing operation within a vasculature of a subject is disclosed. A system can include a catheter having a distal end provided with an inflatable balloon and a plurality of electrodes within the balloon, wherein at least one first electrode is provided as a component of a first emitter and is electrically connected to both a high-voltage pulse generator for performing the IVL operation and a conductance excitation module for performing the sizing operation.

[0015] Preferably, the sizing operation includes a conductance sizing operation using the at least one first electrode operably connected to the conductance excitation module and a spaced apart second electrode operably connected to a conductance sensor for determining at least one of a cross-sectional area or an internal volume of the inflated balloon within the vasculature. The first electrode can be one of a pair of electrodes comprising the first emitter for the IVL operation, such that when the high-voltage pulse is generated, a spark will be generated across the pair of electrodes through a conductive medium within the balloon.

[0016] A third electrode can be provided as a component of a second emitter electrically connected to the high-voltage pulse generator for performing the IVL operation in parallel with the first emitter. Also, the third electrode can be operably connected to the conductance excitation module for performing the sizing operation, and the second emitter is electrically connected in parallel with the first emitter.

[0017] A fourth electrode can be operably connected to the conductance sensor for performing the sizing operation along with the third electrode which can be connected to the conductance excitation module.

[0018] The system preferably can include a control system, wherein two electrodes (e.g., the first electrode and the third electrode) can be electrically connected so as to be excited by the conductance excitation module in parallel with each other to the gauge excitation and sensing control module, and the second electrode and the fourth electrode can be electrically connected so as to provide feedback information to the gauge excitation and sensing control module for determining at least one of a cross-sectional area or an internal volume of the inflated balloon within the vasculature.

[0019] In another aspect of the application, the gauge excitation and sensing control module can further include an AC power source for sensing admittance and a DC power source for sensing conductance, each of the AC power source and the DC power source for providing information about fluids and tissue of the vasculature.

[0020] Preferably, the high voltage pulse generator can be operatively connected with the control system and at least the first emitter and the second emitter, such that the IVL operation can be controllably performed independently of the gauge operation. In one embodiment, at least one electrode of the electrode pair used to generate the spark to emit the acoustic waves can also be used as an excitation or sensing electrode of the gauge excitation and sensing control module.

[0021] In another aspect of the application, a method of performing an intravascular lithotripsy (IVL) operation and a gauge operation within a vasculature of a subject can include a catheter having a distal end provided with an inflatable balloon and a plurality of electrodes within the balloon, and the method can include exciting a first electrode and sensing a conductance or an admittance at a second electrode for performing the gauge operation within the balloon positioned in the vasculature of the subject, and generating a spark between the first electrode provided as one electrode member of a first emitter electrode pair and another electrode member of the first emitter electrode pair by providing a high voltage pulse from a high voltage pulse generator for performing the IVL operation.

[0022] The gauge operation can be performed prior to generating any spark for the IVL operation to provide initial gauge information. Also, one or more gauge operations can be performed after at least one IVL cycle or pulse to provide progress information or confirmation of the IVL operation. Moreover, a gauge operation can be performed after the IVL operation is completed to provide or confirm size information of an implant such as a stent.

[0023] The gauge operation can include a conductance gauge operation using at least one first electrode operatively connected with a conductance excitation module and a spaced apart second electrode operatively connected with a conductance sensor, and the method can further include determining at least one of a cross-sectional area or an internal volume of the inflated balloon within the vasculature.

[0024] The third electrode can be provided as a component of a second transmitter, which is electrically connected with the high-voltage pulse generator, and the method can further comprise performing the IVL operation in parallel with the first transmitter. The third electrode can be operatively connected with the conductance excitation module, and the method can further comprise performing the sizing operation with the second transmitter electrically in parallel with the first transmitter.

[0025] The fourth electrode can be operatively connected with the conductance sensor, and the method can further comprise performing the sizing operation together with the third electrode connected with the conductance excitation module.

[0026] Preferably, such a method comprises using a control system, wherein the first electrode and the third electrode can be electrically connected so as to be excited by the conductance excitation module in parallel with each other by the sizing excitation and sensing control module, and the second electrode and the fourth electrode can be electrically connected so as to provide feedback information to the sizing excitation and sensing control module, and the method can further comprise determining at least one of a cross-sectional area or an internal volume of the inflated balloon within the vasculature.

[0027] The method can further comprise exciting with an AC power source so as to sense admittance and exciting with a DC power source so as to sense conductance, each for providing information about fluids and tissue of the vasculature.

[0028] Preferably, the high-voltage pulse generator can be operatively connected with the control system and at least the first transmitter and the second transmitter, such that the IVL operation can be controllably performed independently of the sizing operation. BRIEF DESCRIPTION OF DRAWINGS

[0029] Figure 1 A sizing balloon is shown, which comprises a plurality of electrodes for exciting and sensing conductance for cross-sectional sizing of the balloon.

[0030] Figure 2 A system for providing intravascular lithotripsy is illustrated in accordance with an aspect of the present invention.

[0031] Figure 3 An inflated balloon for providing intravascular lithotripsy in a blood vessel is illustrated in accordance with an aspect of the present invention.

[0032] Figure 4 An IVL and balloon sizing dual-purpose system of the present invention is schematically illustrated, which comprises at least one electrode, which is part of a transmitter for generating a spark and is also electrically connected with a conductance excitation module.

[0033] Figure 5 is a schematic illustration of an alternative circuit for IVL operation of the system of the present invention.

[0034] Figure 6 is a schematic illustration of circuitry for performing sizing operations using electrical conduction excitation and sensing.

[0035] Figure 7 is a graphical representation of an exemplary manner of performing sizing operations in conjunction with IVL operations for IVL treatment of a lesion. DETAILED DESCRIPTION

[0036] The present invention relates to IVL devices of the type that include electrodes or lithotripsy emitters that produce acoustic waves through electrical arc discharges between electrode components, but can also include devices that produce acoustic energy via a laser energy source within a balloon. Examples of such laser systems are described in U.S. Patents US 11,058,492 and US 11,246,569 (the entire contents of which are incorporated by reference). Examples of electrical induction systems are described in U.S. Patents US 8,728,091, US 9,642,673, and US 10,850,078, and published U.S. Patent Application US 2022-0054194 (the entire contents of which are incorporated by reference).

[0037] Referring to the drawings, Figure 2 and Figure 3 A system 10 according to the present invention is shown, including a console or power source 12 (in the form of a generator, but alternatively in the form of a laser system), a handle 14 with a treatment delivery controller 15, and a catheter 20 with two lithotripsy emitters 22 (shown in the form of a pair of arc electrodes, but alternatively they can include optical or laser emitters) and a fluid-filled balloon 24. An optional marker band B can be provided. The catheter 20 preferably includes a central tube 26 that defines a guide wire lumen 27 through which a guide wire G passes for delivery of the balloon 24 at a desired location along the guide wire G. A sheath 28 surrounds the central tube 26 and defines a delivery lumen 29 through which saline can be controllably delivered for balloon 24 inflation. The lumen 29 provides a concentric space around the central tube 26 within which electrode wires (not shown) can extend from the controller 15 to the emitters 22 and other components according to the present invention and discussed below. The sheath 28 is connected at a proximal end to a hub 17 that can include any number of ports that allow electrode wires to enter into the lumen 29 along with saline for inflation, the guide wire G, and any number of other components as desired.

[0038] Balloon 24 can be placed in a retracted position to more easily pass through a patient’s vasculature to a calcified site. In use, balloon 24 will be inflated to a typical angioplasty pressure (e.g., 4 atm) and treatment initiated via delivery controller 15.

[0039] Figure 3 Balloon 24 is shown inflated to a treatment delivery state, where lithotripsy emitters 22 can be “fired” to break up vascular calcification C. An optional indicator band B can be provided to enable visualization and proper positioning through use of known imaging techniques. Balloon 24 is inflated to a typical angioplasty pressure (e.g., 4 atm) and treatment is initiated. Balloon 24 can naturally expand during or immediately after treatment is initiated to clear the vessel for blood flow. While Figure 2 and Figure 3 Two pairs of electrode pairs emitters 22 are shown in FIGS. 1 and 2, but in alternative embodiments, the number of electrode pair emitters can include only 1 pair, or include 4, 5, 6, or more emitter pairs to treat longer lesions, such as encountered in the peripheral vasculature.

[0040] Controller 15 is used to generate one or a series of voltage pulses according to a treatment protocol. The high voltage pulses are provided to one of emitters 22, which includes a pair of spaced apart electrodes, and then in series to a second emitter 22, which also includes a pair of spaced apart electrodes, according to the illustrated embodiment. The high voltage pulses produce a spark across the first pair of electrodes in succession, and then or again across the second pair of electrodes, within balloon 24. The slightly conductive saline solution within balloon 24 permits the high voltage spark to cross over each pair of electrodes, thereby generating a wave of energy within the balloon that propagates toward the vascular calcification.

[0041] Any spark produced within balloon 24, which is located within a patient’s vasculature, also produces a visible or detectable light event. Such a light event can be detected at wavelengths other than those of visible light. Also, it should be appreciated that a visible or detectable light leader can emanate from the grounded electrode of any electrode pair when a high voltage pulse is initiated on the hot electrode pair prior to the actual spark event. Such a leader is similar to the leader seen to emanate from a conductive object prior to a lightning strike. Monitoring for detectable light to observe the timing of the spark is the subject of co-owned pending U.S. Provisional Patent Application US 63 / 434,912, filed December 22, 2022, the entire contents of which are incorporated herein by reference.

[0042] It is also contemplated that a catheter not including a balloon can be utilized in accordance with the present application. Such a catheter would preferably include a lumen 29 that delivers saline to a controlled volume that includes one or more emitters 22. Such a controlled volume can be created by the structure of the patient's vasculature in conjunction with the catheter distal end in the emitter region. Saline can be provided to fill such a controlled volume, or saline can flow into or out of such a controlled volume at a controlled flow rate. A partial balloon is also contemplated from which saline fluid flow can seep from the open distal end of the partial balloon. Such a partial balloon design or open balloon design can be used with a forward electrode system such as disclosed in pending U.S. Provisional Patent Application US 63 / 416,231 filed October 14, 2022, the entirety of which is incorporated herein by reference. In the case of catheter 20 having a balloon 24, the controlled volume is disposed within the volume of balloon 24.

[0043] Figure 4 A schematic diagram of an IVL and sizing combination system in accordance with the present application is shown in FIG. 12. Specifically, catheter 120 extends to inflatable balloon 124 in a similar manner as described above. Within balloon 124, preferably four or more electrodes are disposed, such as El, E2, E3, and E4 as shown. In accordance with one example of the present application, two of the electrodes, El and E4, can include two emitters 122 that are used to create a plurality of high voltage sparks within balloon 124 to create energy waves for breaking up a lesion within the vasculature, as described above. Specifically, each emitter 122 will include an electrode pair with a pair of wires extending from a control system (as discussed below) to each emitter 122, with one wire connected to each electrode in the electrode pair for creating high voltage sparks as discussed above. The schematically illustrated wires 134 each represent such a pair of electrical wires for connection with emitters 122 including electrodes El and E4. As explained in one example in the Background section, such high voltage pulses can be provided at voltages of three thousand volts or higher, or even up to ten thousand volts or higher.

[0044] To also perform sizing techniques and determinations in accordance with elements within the balloon 124, a pair of conductive sensing electrodes 132 can be provided at the distal end of the catheter 120 similar to the emitters 122. As shown, the conductive sensing electrodes 132 include electrodes E2 and E3, which are each spaced inwardly from the emitter electrodes El and E4. Such spacing is controlled based on determinations of the cross-sectional area of the balloon 124, which are further based on calculations using Ohm's Law. These electrodes E2 and E3 are spaced relative to one another based on the desired measurements of the sizing balloon. For measurements of cross-sectional area, they are closer to one another than for measurements of internal volume. Determinations of the cross-sectional area of the balloon are also discussed in the BACKGROUND section, including calculations made to achieve such determinations. Each of the conductive sensing electrodes 132 is electrically connected by a wire 136 to a control system discussed below.

[0045] According to the present application, such a balloon catheter system can be used as an IVL device to produce energy waves for breaking up a lesion in combination with a sizing device, such as a conductance sizing balloon "CSB". As part of this combination, the electrodes of the pair of emitters 122 can provide not only the functional set for producing high voltage sparks and energy waves, but such electrodes can also provide the conductance excitation for sizing. Since the electrodes of each emitter 122 require a much higher voltage to produce a spark across the electrode pair, as discussed above, the electrodes of each emitter 122 can also be used as the excitation electrodes for sizing. Energy wave pulse production is at a different voltage state than the conductive excitation for sizing, so there is no opportunity to produce a spark when sizing operations are being performed. These dual purpose electrodes allow sizing and energy wave production to be performed by the same dual purpose system without the need to remove one system to replace with another. Advantageously, the dual purpose system of the present application allows for sizing to be performed sequentially with energy wave pulses before or after a determined number or series of energy wave pulses. Thereby, such a system allows for monitoring of lesion break up by performing sizing operations at intervals within the IVL procedure. The final sizing step can indicate to the operator of the system that such a lesion has been successfully broken up. It should be noted that the sizing operation performed with the CSB can include energizing the CSB system with DC and / or AC electricity. With DC electricity, conductance is sensed at the electrodes 132. With AC electricity, admittance is sensed at the electrodes 132. A combination of DC and AC electricity provides measurement information of both fluid and tissue, and as known, such excitation with DC and AC electricity can be done separately or together. As used throughout this specification, the term "conductance" also includes admittance in the same sense as sensed for sizing. Moreover, using the same device to provide both therapy and sizing testing eliminates the need to use two devices, and the attendant delay of threading and removing two separate devices in the patient's vasculature.

[0046] To perform sizing and high voltage spark generation using at least one pair of electrodes for each operation electrical connection, a control system 200 is provided. As Figure 4 As schematically illustrated in FIG. 2, the control system 200 can include a pair of switches 202 for activating the IVL system or the sizing system. Preferably, the switches 202 are arranged in parallel, such that each system can be controlled independently of the other, and more preferably, activation of one switch 202 will deactivate the other, such that only one system can be run at any given time. It is preferred that the two systems are electrically isolated from one another. In particular, during high voltage pulsing and spark generation, the CSB system is electrically isolated from the IVL control to prevent damage to sensitive sensors within the CSB system for measuring conductance.

[0047] The portion of the control system 200 indicated at 204 includes a wire harness that includes two pairs of wires 134 for spark generation and two wires 136 for conductance sensing. As described above, one wire in each pair of wires 134 will also be used for excitation for sizing operations. This wire harness 204 includes splitting certain wires between a sizing excitation and sensing module 206 and a high voltage pulse generator 212. In particular, the wires 136 will each be electrically routed to the sizing excitation and sensing module 206 to provide sensing signals from the electrodes 132 to the module. The two pairs of wires 134 will be routed from the electrodes 122 to the high voltage pulse generator 212 for generating sparks, while one wire in each pair of wires 134 will also be routed to the sizing excitation and sensing module 206 to allow for excitation of the electrodes 122 during sizing operations.

[0048] Control of each system can be accomplished by manual manipulation by an operator, such as switching from IVL operation to sizing operation, or vice versa. Alternatively, some or all of the steps of each operation and / or switching from one operation to another can be automated. Such a control system 200 can include any number of control modules for switching from one operation to another, such as with electronic switches as the switches 202, or for controlling some or all of each sizing operation and / or IVL system operation. Such a control system can include any number of data processors, memory, and programs provided as software or firmware.

[0049] It should be understood that, depending on the example, certain acts or events of any of the methods described herein can be performed in a different sequence, can be added, merged, or omitted altogether (e.g., all described acts or events can not be necessary for the practice of the method). Moreover, in certain examples, acts or events can be performed concurrently, e.g., through multi-threaded processing, interrupt processing, or multiple processors, rather than sequentially. In addition, while certain aspects of this disclosure are described as being performed by a single circuit or unit for purposes of clarity, it can be appreciated that the techniques of this disclosure can be performed by a combination of units or circuits associated with, for example, a medical device.

[0050] In one or more examples, the functions described can be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions can be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media can include computer-readable storage media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0051] Accordingly, as used herein the term "microprecessor" or "processor" can refer to any of the foregoing structure or any other structure suitable for implementation of the techniques described herein. In addition, in some examples, the techniques can be implemented in one or more circuits or logic elements. Furthermore, the described technology can be implemented in software, hardware, firmware or any combination thereof.

[0052] Figure 5 Another circuit for IVL operation is schematically illustrated. Electrodes 302, 304, 306, and 308 can be arranged in that order along a distal portion of catheter 310 at the controlled spacing discussed above. In addition to using the outermost two electrodes 302 and 308 for spark generation and energy wave generation, one or more other electrodes can be used. In the case of firing two emitters, one electrode from any pair of two electrodes can be used. For example, as illustrated, a pair of electrodes can include emitters at 302 and 304 with a pair of wires electrically connecting the emitters to high voltage pulse generator 312. It is contemplated that any one, two, or more of electrodes 302, 304, 306, and 308 can be used for spark generation and IVL operation.

[0053] In Figure 6In this case, the outer two electrodes 302 and 308 are preferably used for excitation during the sizing operation, and the inner two electrodes 304 and 306 are used for sensing conductance. The electrodes 302 and 308 can be electrically connected with an AC or DC excitation module 314, while the electrodes 304 and 306 can be electrically connected with a sensing module 316. The modules 314 and 316 can be integrated together as described above, or as separate functions. In any case, Figure 5 and Figure 6 both illustrate another example of a dual-purpose system for IVL operation and sizing operation.

[0054] Figure 7 is an exemplary plot 400 that plots the cross-sectional dimension of an inflated balloon, such as within a lesion, versus IVL treatment. In this system operation example of the present invention, an initial sizing operation can determine the cross-sectional dimension of the balloon when first introduced into a lesion and expanded. Such an initial sizing operation can provide a determination of the degree of obstruction of a lesion, such as indicated at point 402. Part 404 of the plot illustrates a sizing operation performed during intervals of the IVL operation. For example, the sizing operation can be performed after one or more series of similar or different high pressure pulses at determined intervals. Figure 7 illustrates a sizing operation at uniform intervals of the IVL operation, where the open cross-sectional area of the balloon is increased in a substantially uniform manner. In other examples, the sizing operation can indicate a very different manner of cross-sectional increase of the balloon compared to the IVL operation. In any case, the operator is provided with feedback information in real time regarding the progress and success of the IVL treatment. Optionally, to facilitate the physician’s confirmation of the stent size for implantation at the site, the specific stent size can also be provided on the Y-axis.

[0055] Sensing admittance can be accomplished in a similar manner as sensing conductance with four electrodes as described above. As described in U.S. Published Patent Application US 2022 / 0339428, published October 27, 2022, the entire subject matter of which is incorporated herein by reference, admittance can be measured to determine the volume of a heart chamber. Four electrodes can be spaced apart for measuring volume along a catheter. The electrodes can be placed on the balloon itself (e.g., by ink printing the electrodes), along the catheter shaft itself, or a combination thereof. Excitation of the selected electrodes and sensing at the other selected electrodes is accomplished in a similar manner as discussed above for sensing conductance and determining sizing with the CSB.

Claims

1. A system for performing both intravascular lithotripsy (IVL) and diameter determination procedures within the vascular system of a subject, the system comprising a catheter having a distal end with an inflatable balloon and a plurality of electrodes within the balloon, wherein, At least one first electrode is configured as a component of the first transmitter and is electrically connected to both a high-voltage pulse generator for performing IVL operation and a conductivity excitation module for performing the sizing operation.

2. The system according to claim 1, wherein, The sizing operation includes a conductivity sizing operation, which uses the at least one first electrode operably connected to the conductivity excitation module and a spaced-apart second electrode operably connected to the conductivity sensor to determine at least one of the cross-sectional area or internal volume of the inflated balloon within the vascular system.

3. The system according to any one of the preceding claims, wherein, The first electrode is one of a pair of electrodes of the first transmitter used for IVL operation, such that when a high-voltage pulse is generated, a spark will be generated across the electrode pair through the conductive medium within the balloon.

4. The system according to any one of the preceding claims, further comprising a third electrode, the third electrode serving as a component of a second transmitter electrically connected to the high-voltage pulse generator for performing IVL operation in parallel with the first transmitter.

5. The system according to any one of the preceding claims, wherein, The third electrode is operably connected to the conductivity excitation module for performing the sizing operation, and the second transmitter is electrically connected in parallel with the first transmitter.

6. The system according to any one of the preceding claims, further comprising a fourth electrode operatively connected to the conductivity sensor for performing the sizing operation together with the third electrode connected to the conductivity excitation module.

7. The system according to any one of the preceding claims, further comprising a control system, wherein, The first electrode and the third electrode are electrically connected so that they can be excited by the conductivity excitation module in parallel with each other through the sizing excitation and sensing control module, and the second electrode and the fourth electrode are electrically connected so as to provide feedback information to the sizing excitation and sensing control module for determining at least one of the cross-sectional area or internal volume of the inflated balloon within the vascular system.

8. The system according to any one of the preceding claims, wherein, The calibrating excitation and sensing control module further includes: an AC power supply for sensing admittance; and a DC power supply for sensing conductance, wherein the AC power supply and the DC power supply are respectively used to provide information about the fluid and tissue of the vascular system.

9. The system according to any one of the preceding claims, wherein, The high-voltage pulse generator is operatively connected to the control system and the at least one first transmitter and the second transmitter, enabling the IVL operation to be performed controllably independently of the sizing operation.

10. A method for performing intravascular lithotripsy (IVL) and sizing procedures within the vascular system of a subject, comprising a catheter having a distal end disposed of an inflatable balloon and a plurality of electrodes within the balloon, the method comprising: Excite the first electrode and sense conductance or admittance at the second electrode for performing a diameter determination within the balloon when positioned within the subject's vascular system, and A high-voltage pulse is supplied from a high-voltage pulse generator to generate a spark between a first electrode of an electrode component in a first transmitter electrode pair and another electrode component in the first transmitter electrode pair, for performing IVL operation.

11. The method according to claim 10, wherein, The sizing operation is performed before any spark is generated for the IVL operation to provide initial sizing information.

12. The method according to any one of claims 10 to 11, wherein, A sizing operation is performed after at least one IVL operation to provide progress information for the IVL operation.

13. The method according to any one of claims 10 to 12, wherein, After the IVL operation is completed, a sizing operation is performed to provide size information for implants such as stents.

14. The method according to any one of claims 10 to 13, wherein, The sizing operation includes a conductivity sizing operation, which uses the at least one first electrode operably connected to the conductivity excitation module and a spaced-apart second electrode operably connected to the conductivity sensor, and the method further includes determining at least one of the cross-sectional area or internal volume of the inflated balloon within the vascular system.

15. The method according to any one of claims 10 to 14, further comprising a third electrode as a component of a second transmitter electrically connected to the high-voltage pulse generator, and the method further comprising performing IVL operation in parallel with the first transmitter.

16. The method according to any one of claims 10 to 15, wherein, The third electrode is operatively connected to the conductivity excitation module, and the method further includes performing the calibrating operation using a second transmitter electrically connected in parallel with the first transmitter.

17. The method of any one of claims 10 to 16, further comprising a fourth electrode operatively connected to the conductivity sensor, and the method further comprising performing the sizing operation together with the third electrode when connected to the conductivity excitation module.

18. The method according to any one of claims 10 to 17, comprising a control system, wherein, The first electrode and the third electrode are electrically connected so as to be excited by the conductivity excitation module in parallel with each other through the calibrating excitation and sensing control module, and the second electrode and the fourth electrode are electrically connected so as to provide feedback information to the calibrating excitation and sensing control module, and the method further includes determining at least one of the cross-sectional area or internal volume of the inflated balloon within the vascular system.

19. The method according to any one of claims 10 to 18, wherein, The calibrating excitation and sensing control module, and the method further include: excitation with an AC power supply to sense admittance; and excitation with a DC power supply to sense conductance, wherein excitation with the AC power supply and excitation with the DC power supply are respectively used to provide information about the fluid and tissue of the vascular system.

20. The method according to any one of claims 10 to 19, wherein, The high-voltage pulse generator is operatively connected to the control system and the at least one first transmitter and the second transmitter, enabling the IVL operation to be performed controllably independently of the sizing operation.

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