Endovascular lithotripsy device and system including sizing measurement

Abstract

A system and method for performing both endovascular lithotripsy (IVL) and sizing procedures within a target vascular system. The system may comprise an inflatable balloon and a catheter having a distal end with multiple electrodes within the balloon, wherein at least a first electrode is provided as a component of a first radiator and is electrically connected to both a high-voltage pulse generator for performing IVL procedures and a conductance excitation module for performing sizing procedures. The method may include the steps of: exciting the first electrode and sensing conductance or admittance with a second electrode in order to perform a sizing procedure within a balloon placed in a target vascular system; and generating a spark between a first electrode, provided as one electrode component of an electrode pair of the first radiator, and another electrode component of the electrode pair of the first radiator by applying a high-voltage pulse from a high-voltage pulse generator in order to perform an IVL procedure.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims priority and the benefit thereof to U.S. Provisional Patent Application No. 63 / 461,085, filed on April 21, 2023.

[0002] The present invention is directed to a catheter system for treating vascular thrombi or calcified lesions, etc., by utilizing energy waves that can be generated by electrodes within a conductive fluid medium.

Background Art

[0003] Catheter systems having angioplasty balloons are generally used to apply a physical force by inflating the balloon against calcified lesions in the vasculature to push the calcification back into the vessel wall and press against the vessel wall. Certain such calcified lesions and thrombi are not effectively disrupted by the use of only an angioplasty balloon.

[0004] More recently, catheter systems have been developed that include balloons similar to angioplasty balloons filled with a conductive liquid medium, such as physiological saline solution, to inflate the balloon at a predetermined position in a lesion or thrombus. The catheter system includes one or more pairs of electrodes operably disposed within the conductive liquid medium. The electrodes are pulsed with a high - voltage direct - current current to generate a spark across the gap between the two electrodes in each pulse. The spark within the conductive medium generates an energy wave that propagates through the liquid medium and causes the balloon to physically exert a force against the lesion or thrombus. The propagation of energy also includes the generation of microbubbles that facilitate a physical force. Such devices are known to impart an energy wave acting on a lesion or thrombus for the purpose of disrupting calcification or coagulation.

[0005] Current catheter systems include a treatment sequence that includes the maximum number of consecutive pulses, the minimum delay time following them, and the exact maximum value of the total pulses associated with a particular catheter. One such product specifies the following:

[0006] [Table 1]

[0007] If treatment is not completed after the maximum total pulses per catheter, the doctor must replace the catheter, which involves undesirable costs, delays, and distractions.

[0008] Intravascular lithotripsy (IVL) devices are available for several calcification patterns. Disposable IVL balloon devices are offered in different designs and dimensions for peripheral vascular or coronary artery applications. All designs utilize reusable power sources such as IVL generators. One reusable DC generator has the following specifications:

[0009] [Table 2]

[0010] One such disposable device consists of a fluid-filled balloon angioplasty catheter fitted to a 0.014-inch guidewire, which has two lithotomy dischargers incorporated into a 12 mm long balloon compartment shaft. The fluid-filled balloon (e.g., 50 / 50 saline contrast agent) is inflated to approximately 4 atmospheres, and then an electrical pulse is applied to the dischargers, which generate high-voltage sparks to perform the treatment. Acoustic waves are generated, and calcium is broken down.

[0011] Sizing balloons that utilize conductance are known for measuring the dimensions of parts of a patient's vascular system, and in particular for determining the dimensions of an appropriate stent to be implanted. A known sizing balloon is shown in Figure 1. In this example, an inflated balloon A is shown, filled with saline solution and positioned at the distal end of catheter C. Four electrodes (E1, E2, E3, and E4) are provided at controlled intervals along the catheter within the balloon. In a DC connection, a positive voltage of approximately tens of volts or less is applied to electrodes E1 and E4, and the electrical conductance is measured at electrodes E2 and E3, which are connected with a negative voltage. In an AC connection, the hot side is supplied to electrodes E1 and E4, and electrodes E2 and E3 are connected to neutral. The electrical conductance is determined based on the current / voltage drop ratio, which is directly related to the cross-sectional area of ​​the balloon through Ohm's law. In the measurement, the two outer electrodes E1 and E4 are excited, and the two inner electrodes E2 and E3 sense and measure the voltage signal. This system can be excited with an AC and / or DC power supply to determine the difference between liquid and tissue. For details on such a sizing balloon and sizing determination, see the paper by Svendsen et al., entitled "Conductance sizing balloon for measurement of peripheral artery minimal stent area" (Journal of Vascular Surgery, September 2014), which is incorporated herein by reference in its entirety.

[0012] This paper describes a method for accurately measuring the minimum stent area (MSA) in peripheral arteries using a conductance sizing balloon (CSB). The CSB measures the electrical conductance of the artery to determine its diameter and, consequently, its MSA. Other methods for measuring peripheral artery MSA, such as intravascular ultrasound and angiography, are compared to CSB, but both have limitations and may not yield accurate measurements. CSB offers several advantages over these methods, including its ability to measure MSA in real time without the need for contrast agents. This paper discusses a study evaluating the performance of CSB in measuring peripheral artery MSA. CSB was found to yield accurate and reliable measurements of MSA, with a correlation coefficient of 0.96 compared to intravascular ultrasound measurements. [Overview of the project]

[0013] In one aspect of the present invention, a system for performing both endovascular lithotripsy (IVL) and sizing procedures within a target vascular system is disclosed. The system may comprise an inflatable balloon and a catheter having a distal end with multiple electrodes provided within the balloon, wherein at least a first electrode is provided as a component of a first radiator and is electrically connected to both a high-voltage pulse generator for performing IVL procedures and a conductance excitation module for performing sizing procedures.

[0014] Preferably, the sizing operation includes a conductance sizing operation using at least a first electrode operably connected to a conductance excitation module, and a separated second electrode operably connected to a conductance sensor for determining at least one of the cross-sectional area or internal volume of a balloon inflated in the vascular system. The first electrode may be one of a pair of electrodes comprising a first radiator for IVL operations, and when a high-voltage pulse is generated, a spark is generated across the electrode pair through a conductive medium in the balloon.

[0015] A third electrode may be provided as a component of a second radiator, electrically connected to a high-voltage pulse generator for IVL operation in parallel with the first radiator. Furthermore, the third electrode may be operably connected to a conductance excitation module for sizing operation, and the second radiator is electrically in parallel with the first radiator.

[0016] The fourth electrode, along with the third electrode which can be connected to a conductance excitation module, can be operably connected to a conductance sensor for sizing operations.

[0017] The system may preferably include a control system in which two electrodes (e.g., first and third) are electrically connected and can be excited in parallel by a conductance excitation module by a sizing excitation and sensing control module, and second and fourth electrodes are electrically connected and can provide feedback information to the sizing excitation and sensing control module to determine at least one of the cross-sectional area or internal volume of a balloon inflated in the vascular system.

[0018] In another embodiment of the present invention, the sizing excitation and sensing control module may further comprise an AC power supply so as admittance is sensed and a DC power supply so as conductance is sensed, each for providing information about the fluids and tissues of the vascular system.

[0019] Preferably, the high-voltage pulse generator can be operably connected to a control system and at least first and second radiators, so that the IVL operation can be controlled independently of the sizing operation. In one embodiment, at least one electrode in the electrode pair used to generate sparks and radiate acoustic waves may also function as an excitation or sensing electrode for a sizing excitation and sensing control module.

[0020] In another embodiment of the present invention, a method for performing an endovascular lithotripsy (IVL) and sizing procedure within a target vascular system may include an inflatable balloon and a catheter having a distal end with a plurality of electrodes provided within the balloon, the method may include the steps of: exciting a first electrode and sensing conductance or admittance with a second electrode in order to perform a sizing procedure within the balloon placed in the target vascular system; and generating a spark between a first electrode, provided as one electrode component of a pair of electrodes of a first radiator, and another electrode component of a pair of electrodes of a first radiator by applying a high-voltage pulse from a high-voltage pulse generator in order to perform an IVL procedure.

[0021] Sizing operations may be performed before any sparks occur for IVL operations to provide initial sizing information. Similarly, one or more sizing operations may be performed after at least one IVL cycle or pulse cycle to provide progress information or confirmation of the IVL operation. Furthermore, sizing operations may be performed after the completion of IVL operations to provide or confirm dimensional information for implantation of stents or the like.

[0022] The sizing operation may include, at a minimum, a conductance sizing operation using a first electrode operably connected to a conductance excitation module and a second, separated electrode operably connected to a conductance sensor, and the method may further include the step of determining at least one of the cross-sectional area or internal volume of a balloon inflated in the vascular system.

[0023] A third electrode may be provided as a component of a second radiator electrically connected to a high-voltage pulse generator, and the method may further include the step of performing an IVL operation in parallel with the first radiator. The third electrode may be operably connected to a conductance excitation module, and the method may further include the step of performing a sizing operation in a second radiator electrically in parallel with the first radiator.

[0024] The fourth electrode can be operably connected to a conductance sensor, and the method may further include the step of sizing with a third electrode connected to a conductance excitation module.

[0025] Preferably, such a method includes the use of a control system, wherein the first and third electrodes are electrically connected and can be excited by a conductance excitation module in parallel with each other by a sizing excitation and sensing control module, and the second and fourth electrodes are electrically connected and can provide feedback information to the sizing excitation and sensing control module, and the method may further include the step of determining at least one of the cross-sectional area or the internal volume of the balloon inflated within the vascular system.

[0026] The method can further include both the step of exciting with an AC power source so that admittance is sensed and the step of exciting with a DC power source so that conductance is sensed, each for providing information regarding the fluid and tissue of the vascular system.

[0027] Preferably, the high voltage pulse generator can be operably connected to a control system and at least the first and second emitters, and the IVL operation can be controllably performed independently of the sizing operation.

Brief Description of the Drawings

[0028] [Figure 1] FIG. shows a sizing balloon including a plurality of electrodes for conductance excitation and sensing for sizing the cross-section of a balloon. [Figure 2] FIG. illustrates a system for performing intravascular lithotripsy according to one aspect of the present invention. [Figure 3] FIG. illustrates an inflated balloon in a blood vessel for performing intravascular lithotripsy according to one aspect of the present invention. [Figure 4]This figure schematically illustrates the dual-purpose IVL and balloon sizing system of the present invention, which includes at least one electrode that is part of the radiator for spark generation and is electrically connected to a conductance excitation module. [Figure 5] This is a schematic diagram of an alternative circuit for IVL operation of the system of the present invention. [Figure 6] This is a schematic diagram of a circuit for a sizing operation that utilizes conductance excitation and sensing. [Figure 7] This is a graphical representation of an exemplary method for performing sizing operations along with IVL (intravenous levitation) procedures for lesion treatment. [Modes for carrying out the invention]

[0029] The present invention relates to an IVL device of the type that comprises electrodes or crushing radiators that generate acoustic waves by arc discharge between electrode components, but may also include a device that generates acoustic energy in a balloon via a laser energy source. Examples of such laser systems are described in U.S. Patent Nos. 11,058,492 and 11,246,569 (their entire contents incorporated by reference). Examples of electrically induced systems are described in U.S. Patent Nos. 8,728,091, 9,642,673 and 10,850,078, and U.S. Patent Application Publication No. 2022-0054194 (their entire contents incorporated by reference).

[0030] Referring to the figures, Figures 2 and 3 show a system 10 according to the present invention, comprising a console or power source 12 (in the form of a generator, or alternatively in the form of a laser system), a handle 14 having a treatment delivery control unit 15, and a catheter 20 having two lithotomy emitters 22 (shown in the form of a pair of arc electrodes, but alternatively they may be provided as light or laser emitters), and a fluid-filled balloon 24. An optional marker band B may be provided. The catheter 20 preferably includes a central tube 26 defining a guidewire lumen 27 through which a guidewire G passes to deliver the balloon 24 to a desired position along the guidewire G. A sheath 28 surrounds the central tube 26 and defines a delivery lumen 29 through which saline can be controlledly delivered for inflation of the balloon 24. Lumen 29 provides a concentric space around the central tube 26, within which an electrode wire (not shown) can extend from the control unit 15 to the radiator 22, in particular among several components according to the present invention and discussed below. The sheath 28 is connected at its proximal end to a hub 17, which may include any number of ports that allow the electrode wire to pass into lumen 29, along with saline solution for expansion, a guide wire G, and any number of other components as desired.

[0031] The balloon 24 may be placed in a deflated position to more easily pass through the patient's vascular system and reach the site of calcification. In use, the balloon 24 is inflated to a pressure common in angioplasty (e.g., 4 atmospheres), and the treatment is initiated via the delivery control unit 15.

[0032] Figure 3 shows a balloon 24 inflated to a treatment delivery state, from which a lithotomy radiator 22 can be "fired" to break up vascular calcification C. An optional indicator band B may be provided so that it can be visualized and properly positioned using known imaging techniques. The balloon 24 can be inflated to a typical angioplasty pressure (e.g., 4 atmospheres) to deliver the treatment. The balloon 24 may deflate spontaneously during or immediately after the treatment is delivered and the vessel is cleared for blood passage. Two pairs of electrode-pair radiators 22 are shown in Figures 2 and 3, but in alternative embodiments, the number of electrode-pair radiators may include only one pair, or four, five, six, or even more pairs of radiators to address longer lesions, such as those encountered in the peripheral vascular system.

[0033] The control unit 15 is used to generate one or a series of voltage pulses according to the treatment scheme. The high-voltage pulse is successively applied to one of the radiators 22, each having a pair of separated electrodes, and, according to the exemplary embodiment, then to a second radiator 22, each having a similar pair of separated electrodes. The high-voltage pulse sequentially causes sparks in the balloon 24, across the first electrode pair, and then similarly across the second electrode pair. The somewhat conductive saline solution in the balloon 24 enables the high-voltage sparks across each electrode pair, thus generating energy waves that propagate within the balloon toward vascular calcification.

[0034] Sparks generated within balloon 24, which is placed within the patient's vascular system, also generate visible or detectable light events. Such light events may be detectable at wavelengths other than those of visible light. Furthermore, it is understood that visible or detectable light readers may be emitted from the grounded electrode of any electrode pair when a high-voltage pulse is initiated at the hot electrode pair before the actual spark event. Such readers are similar to those seen emanating from a conductive object before a lightning strike. Monitoring of detectable light for visualizing the timing of sparks is the subject of jointly owned pending U.S. Provisional Patent Application No. 63 / 434912, filed December 22, 2022, the entire contents of which are incorporated herein by reference.

[0035] It is also intended that catheters without balloons may be used in the present invention. Such catheters preferably include a lumen 29 for delivering saline solution to a controlled volume containing one or more radiators 22. Such a controlled volume may be created by the structure of the patient's vascular system, along with the distal end of the catheter in the region of the radiators. Saline solution may be supplied to fill such a controlled volume, or may flow in and out of such a controlled volume at a controlled flow rate. Partial balloons are also intended, from which a fluid flow of saline solution may flow out from the open distal end of the partial balloon. Such partial or open balloon designs may be useful in forward-facing electrode systems, such as those disclosed in pending U.S. Provisional Patent Application No. 63 / 416,231, filed October 14, 2022, the entire contents of which are incorporated herein by reference. In the case of a catheter 20 having a balloon 24, the controlled volume is provided within the volume of the balloon 24.

[0036] A schematic diagram of the combined IVL and sizing system according to the present invention is shown in Figure 4. Specifically, a catheter 120 extends to an inflatable balloon 124, as described above. Four or more electrodes, such as those indicated by E1, E2, E3, and E4, are preferably provided within the balloon 124. According to one embodiment of the present invention, two electrodes E1 and E4 may comprise two radiators 122, used as described above for the purpose of generating multiple high-voltage sparks within the balloon 124 to generate energy waves for destroying lesions in the vascular system. Specifically, each radiator 122 includes an electrode pair having a pair of wires extending from a control system (discussed below) to each radiator 122, with one wire to each of the electrode pairs for generating high-voltage sparks as discussed above. The schematically illustrated wires 134 each represent such a pair of electrical wires for connection to the radiators 122 comprising electrodes E1 and E4. As described in the examples within the background technology section, such high-voltage pulses can be applied at voltages of 3,000 volts or more, or even 10,000 volts or more.

[0037] To perform sizing techniques and determinations from elements within the balloon 124, a pair of conductive sensing electrodes 132 may be provided at the distal end of the catheter 120, similar to the radiator 122. As shown, the conductive sensing electrodes 132 comprises electrodes E2 and E3, each spaced inward from the radiator electrodes E1 and E4. Such spacing is controlled based on the determination of the cross-sectional area of ​​the balloon 124, and further based on calculations using Ohm's law. These electrodes E2 and E3 are spaced apart from each other based on the desired measurement of the sizing balloon. In the measurement of the cross-sectional area, they are closer to each other than in the measurement of the internal volume. The determination of the balloon's cross-sectional area, including the calculations performed for such a determination, is also discussed in the background art section. Each of the conductive sensing electrodes 132 is electrically connected via wire 136 to the control system discussed below.

[0038] According to the present invention, such a balloon catheter system can be used as an IVL device for generating energy waves to destroy lesions in combination with a sizing device such as a conductance sizing balloon "CSB". As part of this combination, the pair of electrodes of the radiator 122 can not only provide functionality for generating high-voltage sparks and energy waves, but such electrodes can also provide conductance excitation for sizing. Each electrode of the radiator 122 can also function as an excitation electrode for sizing, as each electrode of the radiator 122 requires a very high voltage to generate a spark across the electrode pair, as discussed above. The generation of energy wave pulses takes place in a voltage range different from that of conductance excitation for sizing, and therefore there is no possibility of spark generation when performing the sizing operation. These dual-use electrodes allow for sizing and energy wave generation by the same dual-use system without the need to remove one system and replace it with another. Advantageously, the dual-use system of the present invention allows sizing decisions to be made sequentially with energy wave pulses, either before or after a predetermined number or series of energy wave pulses. Such a system, therefore, allows for monitoring of lesion destruction by performing a sizing operation between IVL treatments. The final sizing step can indicate to the system operator that such lesions have been successfully destroyed. It should be noted that the sizing operation using a CSB may include both energizing the CSB system with DC and / or AC power. With DC power, conductance is sensed at electrode 132. With AC power, admittance is sensed at electrode 132. A combination of DC and AC power provides both fluid and tissue measurement information, and excitation with such DC and AC power may be performed separately or together, as is known. Where used herein, the term conductance also includes admittance in the same sense as that sensed for sizing determination.Furthermore, by using the same device to provide both treatment and sizing examinations, the need for two separate devices is eliminated, as well as the delays associated with threading to and removing two separate devices in the patient's vascular system.

[0039] A control system 200 is provided to perform both sizing and high-voltage sparking using at least one pair of electrically connected electrodes in each operation. As schematically illustrated in Figure 4, the control system 200 may include a pair of switches 202 for operating either the IVL system or the sizing system. Preferably, the switches 202 are arranged in parallel so that each system can be controlled independently of the others, and more preferably, the operation of one switch 202 deactivates the other switches so that only one system can operate at any given time. The two systems are preferably electrically isolated from each other. Specifically, the CSB system is electrically isolated from the IVL control unit to prevent damage to the sensing sensors used in the CSB system to measure conductance during the generation of high-voltage pulses and sparks.

[0040] The portion of the control system 200 shown in 204 comprises a wire bundle including two pairs of wires 134 for spark generation and two wires 136 for conductance sensing. As described above, one wire from each pair of wires 134 is also used for excitation for the sizing operation. This wire bundle 204 includes a split in a certain portion of the wire between the sizing excitation and sensing module 206 and the high-voltage pulse generator 212. Specifically, both wires 136 are electrically wired to the sizing excitation and sensing module 206 to provide a sensing signal from electrode 132 to the module. The two pairs of wires 134 are wired from electrode 122 to the high-voltage pulse generator 212 for spark generation, while one wire from each pair of wires 134 is also wired to the sizing excitation and sensing module 206 to enable excitation of electrode 122 during the sizing operation.

[0041] Control of each system may be performed by manual operations by an operator, such as switching from IVL operations to sizing operations and vice versa. Alternatively, some or all of the steps of each operation and / or switching from one operation to another may be automated. Such a control system 200 may include any number of control modules for switching from one operation to another, or for controlling some or all of each sizing and / or IVL system operation, such as utilizing an electronic switch for switch 202. Such a control system may include any number of data processors, memory, and programming provided as software or firmware.

[0042] In some embodiments, certain actions or events of any of the methods described herein may be performed in a different order, and may be added, merged, or completely excluded (for example, not all described actions or events are necessary for the practice of the method). Furthermore, in certain embodiments, actions or events may be performed not sequentially, but simultaneously, for example, through multithreading, interrupt handling, or multiple processors. In addition, while certain aspects of this disclosure are described for clarity as being performed by a single circuit or unit, it should be understood that the techniques of this disclosure may be performed by combinations of units or circuits, for example, in relation to medical devices.

[0043] In one or more embodiments, the functions described may be implemented in hardware, software, firmware, or any combination thereof. When implemented in software, the functions are stored as one or more instructions or codes in a computer-readable medium and executed by a hardware-based processing unit. The computer-readable medium may include computer-readable storage media corresponding to tangible media such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and can be accessed by a computer).

[0044] Accordingly, instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general-purpose microprocessors, application-specific integrated circuits (ASICs), field-programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuits. Therefore, the terms “microprocessor” or “processor” as used herein may refer to either the aforementioned structures or any other structure suitable for carrying out the technology described herein. Furthermore, the technology may be fully implemented by one or more circuits or logic elements.

[0045] Figure 5 schematically illustrates another circuit for IVL operation. Electrodes 302, 304, 306, and 308 may be arranged in that order along the distal portion of the catheter 310 at controlled intervals as discussed above. Instead of using the two outermost electrodes 302 and 308 for spark generation and energy wave generation, one or more of the other electrodes may be used. When firing two radiators, one electrode from any two electrode pairs may be used. For example, as illustrated, a pair of electrodes may consist of radiators in 302 and 304 having a pair of wires that electrically connect the radiators to a high-voltage pulse generator 312. It is intended that one, two, or more of electrodes 302, 304, 306, and 308 may be used for spark generation and IVL operation.

[0046] In Figure 6, it is schematically illustrated that the two outermost electrodes 302 and 308 are preferably used for excitation during the sizing operation, and the two innermost electrodes 304 and 306 are preferably used for sensing conductance. Electrodes 302 and 308 are electrically connected to an AC or DC excitation module 314, while electrodes 304 and 306 are electrically connected to a sensing module 316. Modules 314 and 316 may be integrated together as described above, or as separate functions. In either case, Figures 5 and 6 illustrate another embodiment of a dual-use system for IVL and sizing operations.

[0047] Figure 7 is an exemplary graph 400 plotting the cross-sectional dimensions of an inflated balloon within a lesion for IVL procedures. In an example of operation of this system of the present invention, an initial sizing operation can determine the cross-sectional dimensions of the balloon when it is first introduced into the lesion and inflated. Such an initial sizing operation may result in a determination of the level of occlusion of such a lesion, as shown at point 402. Part 404 of this graph shows the performance of a sizing operation between IVL operations. For example, a sizing operation may be performed after one or more similar or different series of high-voltage pulses at predetermined intervals. Figure 7 illustrates a sizing operation at equal intervals between IVL operations, where the open cross-sectional area of ​​the balloon increases substantially uniformly. In other embodiments, a sizing operation may exhibit a significantly different behavior of increasing balloon cross-sectional area from the IVL operations. In any case, the operator is given real-time feedback information regarding the progress and success of the IVL procedure. If applicable, the dimensions of a particular stent may also be given on the Y-axis for the physician's convenience to confirm the dimensions of the stent for implantation at that site.

[0048] The sensing of admittance can be achieved in a manner similar to the conductance sensing method using the four electrodes discussed above. The admittance can be measured to determine the volume of the cardiac chamber, as described in U.S. Patent Application Publication No. 2022 / 0339428, published on 27 October 2022, whose entire subject matter is incorporated herein by reference. The four electrodes can be spaced along the catheter to measure the volume. The electrodes can be placed on the balloon itself (e.g., by ink-printing the electrodes), along the catheter shaft itself, or in a combination thereof. Excitation of the selective electrode and sensing in the other selective electrodes are performed in a manner similar to the method discussed above to sense conductance and determine sizing in the CSB. [Explanation of Symbols]

[0049] 10 Systems 12 Console or power source 14 handles 15 Treatment Delivery Control Unit 17 Hubs 20 Catheters 22 Electrode-to-Radiator 24 Fluid-filled balloons 26 Central tube 28 Sheath 29 delivery lumens 120 catheters 122 Radiators, electrodes 124 Balloons 134 wires 136 wires 200 Control Systems 202 Switch 204 Wire Bundle 206 Sensing Module 212 High-voltage pulse generator 302 Electrode 304 Electrode 306 Electrode 308 Electrode 310 Catheter 312 High-voltage pulse generator 314 AC or DC Excitation Module 316 Sensing Module 400 Graphs and Charts 402 points 404 Graph section A inflated balloon B Marker band, indicator band C catheter E1 electrode E2 electrode E3 electrode E4 electrode G guidewire

Claims

1. A system for performing both endovascular lithotripsy (IVL) and sizing procedures within a target vascular system, comprising an inflatable balloon and a catheter having a distal end with multiple electrodes provided within the balloon, wherein at least a first electrode is provided as a component of a first radiator and is electrically connected to both a high-voltage pulse generator for performing IVL and a conductance excitation module for performing the sizing procedure.

2. The system according to claim 1, wherein the sizing operation includes a conductance sizing operation using at least a first electrode operably connected to the conductance excitation module, and a separated second electrode operably connected to a conductance sensor for determining at least one of the cross-sectional area or internal volume of the balloon inflated in a vascular system.

3. The system according to any one of claims 1 to 2, wherein the first electrode is one of a pair of electrodes comprising the first radiator for IVL operation, and when a high-voltage pulse is generated, a spark is generated across the electrode pair through a conductive medium in the balloon.

4. The system according to any one of claims 1 to 3, further comprising a third electrode as a component of a second radiator electrically connected to the high-voltage pulse generator for performing IVL operation in parallel with the first radiator.

5. The system according to any one of claims 1 to 4, wherein the third electrode is operably connected to a conductance excitation module for performing the sizing operation, and the second radiator is electrically in parallel with the first radiator.

6. The system according to any one of claims 1 to 5, further comprising a fourth electrode operably connected to the conductance sensor for performing the sizing operation, together with the third electrode connected to the conductance excitation module.

7. The system according to any one of claims 1 to 6, further comprising a control system wherein the first and third electrodes are electrically connected and excited in parallel with each other by the conductance excitation module by the sizing excitation and sensing control module, and the second and fourth electrodes are electrically connected and provide feedback information to the sizing excitation and sensing control module to determine at least one of the cross-sectional area or internal volume of the balloon inflated in the vascular system.

8. The system according to any one of claims 1 to 7, wherein the sizing excitation and sensing control module further comprises an AC power supply so as admittance is sensed and a DC power supply so as as conductance is sensed, each for providing information about the fluid and tissue of the vascular system.

9. The system according to any one of claims 1 to 8, wherein the high-voltage pulse generator is operably connected to the control system and at least the first and second radiators, and the IVL operation can be controlled independently of the sizing operation.

10. A method for performing endovascular lithotripsy (IVL) and sizing procedures within a target vascular system, comprising an inflatable balloon and a catheter having a distal end equipped with multiple electrodes inside the balloon, The steps include: exciting a first electrode and sensing conductance or admittance with a second electrode in order to perform a sizing operation within the balloon placed in the target vascular system; The step of performing an IVL operation involves applying a high-voltage pulse from a high-voltage pulse generator to generate a spark between a first electrode, which is provided as one electrode component of the electrode pair of the first radiator, and another electrode component of the electrode pair of the first radiator. Methods that include...

11. The method according to claim 10, wherein the sizing operation is performed before any occurrence of a spark for the IVL operation in order to provide initial sizing information.

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

13. The method according to any one of claims 10 to 12, wherein the sizing operation is performed after the completion of the IVL operation to provide dimensional information for the implantation of a stent or the like.

14. The method according to any one of claims 10 to 13, wherein the sizing operation includes a conductance sizing operation using at least a first electrode operably connected to the conductance excitation module and a separated second electrode operably connected to a conductance sensor, and the method further includes the step of determining at least one of the cross-sectional area or internal volume of the balloon inflated in 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 radiator electrically connected to the high-voltage pulse generator, wherein the method further includes the step of performing an IVL operation in parallel with the first radiator.

16. The method according to any one of claims 10 to 15, wherein the third electrode is operably connected to a conductance excitation module, and the method further comprises the step of performing the sizing operation with the second radiator electrically in parallel with the first radiator.

17. The method according to any one of claims 10 to 16, further comprising a fourth electrode operably connected to the conductance sensor, wherein the method further includes the step of performing the sizing operation together with the third electrode connected to the conductance excitation module.

18. The method according to any one of claims 10 to 17, comprising a control system, wherein the first and third electrodes are electrically connected and excited in parallel with each other by a conductance excitation module by a sizing excitation and sensing control module, the second and fourth electrodes are electrically connected and provide feedback information to the sizing excitation and sensing control module, and the method further comprises the step of determining at least one of the cross-sectional area or internal volume of the balloon inflated in the vascular system.

19. The method according to any one of claims 10 to 18, wherein the sizing excitation and sensing control module and the method further comprises the steps of exciting with an AC power supply so that admittance is sensed and exciting with a DC power supply so that conductance is sensed, each for providing information relating to 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 operably connected to the control system and at least the first and second radiators, and the IVL operation can be controlled independently of the sizing operation.

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