Patent ID: 12220141

DETAILED DESCRIPTION

The following description is presented to enable a person of ordinary skill in the art to make and use the various embodiments disclosed herein. Descriptions of specific devices, assemblies, techniques, and applications are provided only as examples. Various modifications to the examples described herein will be readily apparent to those of ordinary skill in the art, and the general principles described herein may be applied to other examples and applications without departing from the spirit and scope of the various embodiments. Thus, the various embodiments are not intended to be limited to the examples described herein and shown, but rather are to be accorded the scope consistent with the claims.

Described herein are systems and methods for implementing a power source for a shock wave catheter system. The power source includes separate voltage sources: a bubble generation voltage source and an arc generation voltage source. The bubble generation voltage source can provide a lower voltage to a pair of electrodes of a shock wave catheter system. The lower voltage can be configured to induce electrolysis of a fluid that surrounds the pair of electrodes of the shock wave catheter system for generating and growing a bubble. Once a bubble has formed, the arc generation voltage source can then be engaged to provide a high-voltage electrical pulse to the electrodes of the shock wave catheter system, thereby generating an electrical arc (i.e., spark) across the electrodes. In one or more examples, the bubble generation voltage source and the arc generation voltage source can be placed together in a single circuit but configured such that they are independently controllable. In one or more examples, both voltage sources can be electrically separated from one another using one or more electrical components, such as inductors and diodes, so that the operation of one voltage source does not impact the operation of the other voltage source.

As used herein, the term “electrode” refers to an electrically conducting element (e.g., made of metal) that receives electrical current and subsequently releases the electrical current to another electrically conducting element. In the context of the present disclosure, electrodes are often positioned adjacent to each other, such as in an arrangement of an inner electrode and an outer electrode. Accordingly, as used herein, the term “electrode pair” refers to two electrodes that are positioned adjacent to each other such that application of a sufficiently high voltage to the electrode pair may cause an electrical current to transmit across the gap (also referred to as a “spark gap”) between the two electrodes (e.g., from an inner electrode to an outer electrode, or vice versa, optionally with the electricity passing through a conductive fluid or gas therebetween). In some contexts, one or more electrode pairs may also be referred to as an electrode assembly. In the context of the present disclosure, the terms “shock wave emitter” and “shock wave generator” broadly refer to the region of an electrode assembly where the current travels across the electrode pair, generating a shock wave. In the context of the present disclosure, the term “emitter” broadly refers to the region of an electrode assembly where the current transmits across the electrode pair, generating a shock wave. The term “emitter sheath” refers to a sheath of conductive material that may form one or more electrodes of one or more electrode pairs, thereby forming a location of one or more emitters. The term “emitter band” refers to a band of conductive material that may form one or more electrodes of one or more electrode pairs, thereby forming a location of one or more emitters.

As provided herein, it should be appreciated that any disclosure of a numerical range describing dimensions or measurements such as thicknesses, length, weight, time, frequency, temperature, voltage, current, angle, etc. is inclusive of any numerical increment or gradient within the ranges set forth relative to the given dimension or measurement. Furthermore, numerical designators such as “first”, “second”, “third”, “fourth”, etc. are merely descriptive and do not indicate a relative order, location, or identity of elements or features described by the designators. For instance, a “first” shock wave may be immediately succeeded by a “third” shock wave, which is then succeeded by a “second” shock wave. As another example, a “third” emitter may be used to generate a “first” shock wave, and vice versa. Accordingly, numerical designators of various elements and features are not intended to limit the disclosure and may be modified and interchanged without departing from the subject invention.

FIG.1illustrates a simplified view of a shock wave catheter system, according to examples of the disclosure. The system100ofFIG.1is meant to provide an exemplary context to the pulse generator described below and should not be seen as limiting to the disclosure. The systems and methods described below could be applied to various shock wave catheter systems that may be implemented in a manner that is different from the system100ofFIG.1.

In one or more examples, the shock wave catheter100can include an elongated tube104and a balloon102. In the example of system100, the balloon102wraps circumferentially around a portion of the elongated tube104in a sealed configuration via, for example, a seal122. The balloon102forms an annular channel124around the elongated tube104through which a conductive fluid, such as saline, may be admitted to the balloon102via fill ports126. The balloon102can be filled with a conductive fluid such that the balloon102can be inflated and be in apposition along, or in contact with, the walls of a body lumen (such as the walls of an artery proximate to a calcified lesion). Unlike traditional angioplasty balloons which are often inflated to a pressure where the exterior of such balloons is frictionally fit to the vessel walls, the balloon102can be inflated to a relatively lower pressure sufficient to position the exterior of balloon102at a target location within a body lumen, thereby forming gentle contact with the walls of a body lumen. In one or more examples, the conductive fluid may also contain an x-ray contrast fluid to permit fluoroscopic viewing of the catheter by a surgeon during use.

In one or more examples, the elongated tube104can include a number of longitudinal grooves or channels configured for retaining wires, fiber optic cables, and/or inner electrodes. The elongated tube104, for instance, can include a plurality of (e.g., four) grooves that extend along the length of the elongated tube104for receiving insulated wires130,132,134, and136(which may be fiber optic cables in other embodiments). The distal ends of the insulated wires can be coupled to a number of shock wave generators106located within the balloon102and circumferentially wrapped around the elongated tube104. Each of the shock wave generators106includes at least one electrode pair, with the electrodes of each pair spaced apart from one another by a distance, creating a gap. The gap (distance between the electrodes of an electrode pair) may vary according to the magnitude of the high voltage pulse applied to the shock wave generator106. For example, a gap of about 0.004 inches (101.6 μm) to about 0.006 inches (152.4 μm) may be effective for shock wave generation using voltage pulses of about 3,000 V.

The system10includes a pulse generator150that is coupled to the proximal ends of the insulated wire130and the insulated wire136. The insulated wires provide one or more voltages to the shock wave generators106. As a voltage is applied across the insulated wires by the pulse generator150, each pulse initially ionizes the conductive fluid inside the balloon102to generate small gas bubbles around the shock wave generators106that insulate the electrodes. Subsequently, a plasma arc forms across a gap between the electrodes of the electrode pairs, generating a low impedance path where current flows freely. The heat from the plasma arc heats the conductive fluid to generate a rapidly expanding vapor bubble. The expansion and collapse of the vapor bubble generates a shock wave that radiates outwardly though the balloon102and then through the blood to the calcified lesion proximate to the balloon102.

As shown inFIG.1, the catheter100has three shock wave generators106where an emitter band constitutes the outer electrode for each shock wave generator. However, this is provided for example only and should not be construed as limiting in any manner as the catheter100could include one shock wave generator, two shock wave generators, or more than three shock wave generators. When the catheter100includes multiple shock wave generators, the shock wave generators106may be located within close proximity to one another such that the shock waves generators106can constructively interfere with one another. For instance, the shock wave generators106can be spaced apart longitudinally less than 6 mm (0.2362 inches) from one another, such as spaced apart by a distance between 1 mm (0.0393 inches) and 4 mm (0.1574 inches) (or at increments of distance therebetween), such that the shock waves generated at a first shock wave generator and a second shock wave generator constructively interfere to produce a combined shock wave. This distance that the shock wave generators106are spaced apart can be measured either from edge-to-edge or from centerpoint-to-centerpoint of two proximate or adjacent shock wave generators106.

The elongated tube104includes a lumen through which a guidewire120is inserted. In operation, a physician uses the guidewire120to guide the elongated tube104into position proximate to a calcified lesion in a body lumen. Once positioned, the pulse generator150is used to deliver a series of pulses to generate a series of shock waves at the shock wave generators106within the balloon102and within the body lumen being treated. The magnitude of the shock waves can be controlled by controlling the magnitude of the pulsed voltage, the current, the duration, and the repetition rate of the voltage supplied by the pulse generator150. The physician may start with low energy shock waves and increase the energy as needed to crack calcified plaques. Such shock waves may travel through the conductive fluid within the balloon102, through the blood to the calcified lesion where the energy may break apart or crack the hardened plaques.

In one or more examples, the pulse generator150can generate voltages at the electrodes for multiple distinct and specific purposes. First, the pulse generator can be configured to generate and apply a first voltage at the electrodes for priming an aqueous environment and/or generating one or more bubbles in the fluid. In some examples, the first voltage is applied across the electrodes. Second, the pulse generator can be also configured to generate and apply a second voltage at the electrodes for generating an arc at the electrodes. In some examples, the second voltage is applied across the electrodes. The arc may generate the shock wave that is used to break apart calcified lesion or other abnormality in the body lumen. In one or more examples, the two voltages can be generated by the same voltage source, but as discussed in detail below, having a single voltage source generate both voltages (e.g., a first voltage for generating a bubble, and a second voltage for generating an arc) can be inefficient and lead to a device with an unnecessarily large footprint/size for the voltage source.

Although shock wave devices described herein generate shock waves based on high voltage applied to electrodes, it should be understood that a shock wave device additionally or alternatively may comprise a laser and optical fibers as a shock wave emitter system whereby the laser source delivers energy through an optical fiber and into a fluid to form shock waves and/or cavitation bubbles.

FIGS.2A and2Billustrate pulse generator configurations that use the same voltage source to generate the voltages for bubble generation and arc generation. The pulse generators200and214ofFIGS.2A and2B, respectively, can be configured to generate both a bubble and an arc at electrodes of a shock wave generator. The pulse generator200ofFIG.2Acan operate in a charging mode202, wherein the voltage source206(labeled as V1 in the figure) can charge a capacitor210(labeled as C1 in the figure) through a resistor208(labeled as R1 in the figure). In a discharge mode204, the electrodes212can be selectively electrically coupled to the capacitor210by, e.g., closing a switch (not shown), thereby causing the energy stored in the capacitor (e.g., in the form of accumulated electrical charge) to discharge onto the electrodes212. The electrodes212can be electrically coupled to the capacitor210via a variable resistor (not shown) that can be used to limit the amount of current supplied by the capacitor210to the electrodes212. The amount of current can be adjusted based on whether the catheter system is generating a bubble or generating an arc. For instance, to prime an aqueous environment and/or generate a bubble, the resistance of the variable resistor can be set relatively high such that a smaller potential difference between the electrodes212is generated. When the bubble has grown, to generate an arc, the variable resistor can have its resistance lowered to near zero, thereby allowing the full charge stored at the capacitor210to be discharged onto the electrodes212. The electrical arc at the electrodes212can cause the shock wave catheter system to generate a shock wave. Additional details of bubble generation and arc generation using the same voltage source are provided in U.S. Pat. No. 9,138,249, which is incorporated by reference.

The pulse generator214ofFIG.2Bcan operate in substantially the same manner as the pulse generator200ofFIG.2Adescribed above. The pulse generator214ofFIG.2Bcan be configured as a Marx generator. During the charging mode216, a voltage source220(labeled as V1 in the figure) can charge a plurality of capacitors222that are coupled to the voltage source220in parallel. In one or more examples, when the circuit is operated in the charging mode216, the electrodes212can be decoupled from the rest of the circuit such that the capacitors222charge without discharging any of their energy onto the electrodes212. During the discharge mode218, the capacitors222can be coupled in series with one another thereby allowing for a high voltage pulse to be discharged at the electrodes212, which are also electrically coupled to the capacitors222. Similar to the example system200ofFIG.2A, the electrodes212can be electrically coupled to the capacitors222via a variable resistor (not shown) that can be used to limit the amount of current supplied by the capacitors222to the electrodes212. For instance, to prime an aqueous environment and/or generate a bubble, the resistance of the variable resistor can be set relatively high so as to generate a smaller potential difference between the electrodes212. When the bubble has grown, to generate an electrical arc, the variable resistor can have its resistance lowered to near zero, thereby allowing the full charge stored at capacitors222to be discharged onto the electrodes212, which in turn can cause the shock wave catheter system to generate a shock wave. Additional details of Marx generators are provided in U.S. Pat. No. 7,855,904, which is incorporated by reference.

The use of the same power source (the capacitor210and voltage source206in system200ofFIG.2A, or the set of capacitors222and voltage source220in system214ofFIG.2B) to supply both the voltage needed to generate a bubble and the voltage needed to generate an electrical arc can present some disadvantages. For instance, by sharing a single voltage source between the bubble generation mode of operation and the arc generation mode, the pulse generator is not independently controllable; generating the bubble and generating the arc are dependent processes. Furthermore, using a single voltage source can require that the voltage source be large enough to support both bubble generation and arc generation modes, since a portion of the energy generated by the voltage source must be discharged to grow a bubble, but the capacitors must also preserve ample energy to generate an electrical arc. The variable resistor used to limit the amount of charge provided to the electrodes during bubble generation mode may convert some of the energy to heat, wasting some of the energy generated by the single voltage source. A voltage source used for both bubble generation and arc generation may have to be larger than otherwise necessary in order to account for these inefficiencies.

In one or more examples of the present disclosure, a pulse generator that utilizes separate bubble generation and arc generation voltage sources may provide overall benefits to the pulse generator that can mitigate the inefficiencies described above. By utilizing separate voltage sources, the bubble generation voltage source can be independently controlled from the arc generation voltage source. This can lead to more efficient use of each voltage source since, unlike a single voltage source system, energy is not wasted in a resistor that has to be used to limit the current being applied to the electrodes during the bubble generation mode of operation. However, configuring the pulse generator with two separate voltage sources can present various challenges. For instance, a pulse generator with two separate voltage sources may need to be configured to offer a high degree of controllability such that the first and second voltage sources can be operated independently from one another, without the operation of one voltage source affecting the operation of the other voltage source.

FIG.3illustrates an exemplary pulse generator configuration with separate bubble generation and arc generation voltage sources, according to examples of the disclosure. In one or more examples, the pulse generator300ofFIG.3can include multiple (e.g., two) separate and independently controllable voltage sources302and304(both coupled to the reference potential316). The first voltage source, referred to as bubble generation voltage source302(labeled as V2 in the figure), can be configured to generate a voltage at electrodes314(discussed in further detail below) that can allow for the electrodes314to generate a bubble in a fluid surrounding the electrodes. The second voltage source, referred to as arc generation voltage source304(labeled as V1 in the figure), can be configured to generate a voltage at electrodes314that can allow for the electrodes314to generate an electric arc in a formed bubble that may generate a shock wave similar to the manner described above. In one or more examples, the arc generation voltage source304can be implemented as a Marx generator (similar to the example described above with respect toFIG.2B). Additionally or alternatively, the arc generation voltage source304can be implemented as a cap charger (similar to the example described above with respect toFIG.2A).

In one or more examples, the bubble generation voltage source302can generate a voltage that is less than the voltage generated by arc generation voltage source304. For instance, in one or more examples, the bubble generation voltage source302can generate a voltage in the range of fifty to two hundred fifty volts (50-250 V), and the arc generation voltage source304can generate a voltage in the range of two thousand to ten thousand volts (2,000-10,000 V), inclusive of increments or gradients of voltages within each of these ranges. The voltage generated may be based on one or more factors, such as application, bubble size, etc. For example, the voltage generated may be based on the number, size, properties, etc. of electrodes in the catheter system, where a certain amount of energy may be needed in order to form a bubble around the electrodes. As another non-limiting example, the time that the bubble generation voltage source302and/or arc generation voltage source304are on and the energy generated may be based on bubble size. The bubble size may be such that one bubble fills the hole of a shock wave generator106, for example.

In one or more examples, the pulse generator300ofFIG.3can include one or more separation components that are configured to electrically separate the bubble generation voltage source302from the arc generation voltage source304. For instance, in one or more examples, the separation components can include an inductor310and a diode318. In one or more examples, the inductor310can be configured to provide separation between the bubble generation voltage source302and the arc generation voltage source304. Similarly, diode318can serve as a protection diode that can provide a current path for the arc generation voltage source304and protect bubble generation voltage source302from the negative voltage associated with the operation of the arc generation voltage source304.

In one or more examples, one or more (e.g., each) of the bubble generation voltage source302and the arc generation voltage source304can be coupled to a switch306and a switch308, respectively, that are independently controllable (described in detail below). When closed, switch306can be configured to selectively electrically couple bubble generation voltage source302to the one or more electrodes314. Similarly, when closed, switch308can be configured to selectively electrically couple arc generation voltage source304to the one or more electrodes314. In one or more examples, switches306and308can be independently closed and open by one or more controllers309that are coupled to the inputs of the switches. In one or more examples, the switches306and308can be controlled by common controller, or alternatively, by separate controllers. Additionally, switches306and308can be implemented as insulated bi-polar gate (IGBT) switches, Metal Oxide Semiconductor Field Effect Transistor (MOSFET) switches, or any other suitable switch types known in the art. In one or more examples, the one or more controllers309used to control the switch can be configured to receive an external input and, based on the received input, control the switches306and308to generate shock waves. Examples of the external inputs to the controller can include receiving an indication that a mechanical or electronic button of a user interface311has been pushed by a user of the device. In response to the indication that the mechanical or electronic button has been pushed, the controller(s)309can transmit a signal to each of the switches306and308so as to close or open the switches. As will be described in further detail below, upon a determination that a user of the device has pushed a mechanical or electronic button (indicating that they wish to have the system generate one or more shock waves), the controller(s)309can control the switches in an ordered manner so as to cause a shock wave to be generated and can continue generating shock waves at a pre-determined interval until the user releases the mechanical or electronic button.

Note that inFIG.3, inductor312represents the inductance of the wire that couples the pulse generator components (described above) to the electrodes314, and resistor320represents the initial resistance of the fluids around the electrodes314. The inductor312and the resistor320are not implemented as actual components in the pulse generator, but instead represent effects caused by the wiring associated with the pulse generator, as well as the fluid surrounding the electrodes314.

The pulse generator300can be configured to operate in a plurality of modes. For example, in a bubble generation mode, the bubble generation voltage source302is electrically coupled to the electrodes314, and generates and applies a voltage at (including across) the electrodes314to induce electrolysis in the fluid surrounding the electrodes314. The pulse generator, upon determining that a bubble has formed (described in detail below) can then operate in an arc generation mode. In the arc generation mode, the arc generation voltage source304can be electrically coupled to the electrodes314, and generates and applies a voltage at (including across) the electrodes314to generate an electrical arc at the electrodes314.

FIG.4illustrates an exemplary pulse generator configuration when the pulse generator is operating in a bubble generation mode, according to examples of the disclosure. In one or more examples, during bubble generation mode, the bubble generation voltage302can be electrically coupled to the electrodes314by closing the switch306. Also, during bubble generation mode, the switch308(associated with the arc generation voltage source304) can remain open such that the arc generation voltage source304is electrically decoupled from the electrodes314, thereby not providing any current of its own to the electrodes314. As illustrated inFIG.4, when operating in bubble generation mode, closing the switch306generates a current pathway402, allowing current from the bubble generation voltage source302to reach the electrodes314.

In one or more examples, the current along the current pathway402can flow through inductor312before reaching the electrode314. In one or more examples, in bubble generation mode, the bubble generation voltage source302can be on for a duration such that the initially high impedance of inductor312is lowered to a low value, where it acts as a wire that allows current to flow to the electrodes314.

The bubble generation mode is configured to prime an aqueous environment and/or generate one or more bubbles at the electrodes314when surrounded by a fluid (e.g., saline). In one or more examples, generating a bubble is a prerequisite for generating an electrical arc, which can generate a shock wave. Without a sufficiently large bubble, the arc generating voltage source304may not be able to generate an arc despite its high voltage. In one or more examples, the bubble generation mode can be terminated based on the size of the bubble. Examples of the disclosure include determining that the size of a bubble meets a certain threshold size, and then terminating the bubble generation mode. In one or more examples, the determination of the bubble size relative to the threshold size can comprise monitoring the amount of time the bubble generation mode has been active and terminating the bubble generation mode once a threshold amount of time has passed.

Additionally or alternatively, the size of the bubble may be determined through the use of a feedback loop that can measure the amount of current, along current pathway402, that is being delivered to the electrodes314. The bubble generation mode can be terminated once the measured amount of current meets a threshold amount of current. In one or more examples, the bubble generation mode can be terminated when the current delivered to the electrodes314is below one hundred microampere (<100 μA). In one or more examples, terminating the bubble generation mode can include opening switch306to electrically decouple the bubble generation voltage source302from the electrodes314. Additionally or alternatively, terminating the bubble generation mode can include initiating the arc generation mode including, but not limited to, leaving the bubble generation voltage source302electrically coupled to the electrodes314via keeping switch306closed.

FIG.5illustrates an exemplary pulse generator configuration when the pulse generator is operating in an arc generation mode, according to examples of the disclosure. In one or more examples, the arc generation mode of the pulse generator can be initiated by closing switch308, thereby electrically coupling the arc generation voltage source304with the electrodes314. In one or more examples, the switch306can remain closed during the arc generation mode, causing the bubble generation voltage source302to also be electrically coupled to the electrodes314. Since the bubble generation voltage source302is independently controllable from the arc generation voltage source304, switch306can be opened at any point during the arc generation mode including at any time during the arc generation mode or even when the arc generation mode is terminated.

In one or more examples, closing switch308at the initialization of the arc generation mode as described can generate a current along current pathway502from the arc generation voltage source304to the electrodes314. The impedance of the inductor310may restrict the current from the arc generation source304, reducing or preventing current flow towards the bubble generation voltage source302, thereby electrically separating the arc generation voltage source304from the bubble generation voltage source302. Additionally or alternatively, a diode or other electronic component can be used to restrict current flow from the arc generation voltage source304to the bubble generation voltage source302.

In one or more examples, and as illustrated inFIGS.3,4, and5, the arc generation voltage source304can be arranged in the pulse generator500such that its polarity is opposite that of the bubble generation voltage source302(opposite polarity arrangement). Arranging the arc generation voltage source304such that its polarity is opposite to that of the polarity of the bubble generation voltage source302can provide some advantages. For instance, the opposite polarity arrangement can allow for diode318to have a lower break down voltage than the same polarity arrangement, since the diode318may need to withstand the high voltage being generated by the arc generation voltage source304in addition to withstanding the voltage generated by the bubble generation voltage302. Additionally, by arranging the arc generation voltage source304so that it is of opposite polarity to the bubble generation voltage source302, current can reach the electrodes314from the opposite direction. In one or more examples, during the bubble generation mode, the current can reach the top electrode314T (with respect to the orientation of the figure), as shown inFIG.3. During the arc generation mode, the current can reach the bottom electrode314B. Allowing electrons to be inserted from different ends can preserve the life of the electrodes314. Alternatively, the arc generation voltage source304can be arranged to have the same polarity as the bubble generation voltage source302same (polarity arrangement, not shown in the figure).

In one or more examples, the arc generation mode can be terminated when it has been determined that the amount of current delivered to electrodes314meets a threshold amount of current. In some examples, the threshold amount of current can be the current needed to generate an electrical arc at the electrodes314. The system can determine that the threshold amount of current has been delivered to the electrodes314based on, e.g., a threshold amount of time passing from the initialization of the arc generation mode (e.g., when switch308has been closed) before opening switch308to terminate the arc generation mode. Additionally or alternatively, the arc generation mode can be terminated based on measuring the amount of current flowing via current pathway502from the arc generation voltage source304to the electrodes314, and determining that a threshold amount of current has been delivered to the electrodes314. For example, if the current is measured to be at or above a minimum threshold of fifty amperes (≥50 A), this can be taken as an indicator that an arc has formed and further delivery of current can be terminated for the given cycle of arc generation.

In one or more examples, the timing relationships between the bubble generation mode and the arc generation mode can be controlled by controlling the switches. The catheter system can operate in bubble generation mode for a longer period of time than in the arc generation mode, and as such, the switch306can be closed for longer period of time than the switch308. This can be because it may take a longer time to form a bubble than it can be to generate an arc to thereby generate a shock wave.

FIG.6illustrates an exemplary switch timing diagram for a pulse generator with separated bubble generation and arc generation voltage sources, according to examples of the disclosure. In one or more examples, the timing diagram600can represent the timing relationships between the bubble generation mode and the arc generation mode, and specifically the timing relationships between the various switches used to initiate each mode, as described above. In one or more examples, the pulse generator described above with respect toFIGS.3-5can operate in an initialization mode602such that both switches306and308are open and the electrodes314are not receiving any current or voltage from the bubble generation voltage source302or the arc generation voltage source304.

In one or more examples, the pulse generator can operate in the bubble generation mode604by closing the switch306(shown in the figure as a change from low to high), electrically coupling the bubble generation voltage source302with the electrodes314. In one or more examples, the arc generation mode606can be initialized by closing the switch308(shown in the figure as a change from low to high), electrically coupling the arc generation voltage source304with the electrodes314. In one or more examples, when switch308is closed at the initialization of the arc generation mode606, switch306can be opened (shown in the figure as a change from high to low). Alternatively, switch306can be left closed even when switch308is closed.

In one or more examples, once it has been determined that a sufficient arc has been generated (as discussed above), switch308can be opened (thereby terminating the electrical coupling between the arc generation voltage source304and the electrodes314) and causing the pulse generator to enter a charge mode608. In charge mode608, the fluid can be allowed to surround the electrodes, and any capacitors that store charge in the arc generation voltage source304can be allowed to charge. In one or more examples, during the charge mode608, both switches306and308can be opened. In one or more examples, if switch306has not already been opened during arc generation mode606, then it can be opened when the pulse generator enters the charge mode608. Furthermore, the charge mode608, with a suitable combination of electrode material and metal ions present in the fluid (e.g., saline solution), can be used to plate the electrodes with fresh material, counteracting any damage to the electrodes incurred during the arc generation mode606.

As demonstrated by the timing diagram600ofFIG.6, the bubble generation mode604can be longer than the arc generation mode606, meaning that switch306can be closed for a longer period of time than switch308and/or the bubble generation voltage source302may be on for a longer period of time than the arc generation voltage source304. By separating the voltage sources (e.g., bubble generation voltage source302separate from an arc generation source304), the timing of the pulse generator can be made more efficient since the operation of the switches do not have to be coordinated.

FIG.7illustrates an exemplary process for operating a pulse generator with separate bubble generation and arc generation voltage sources, according to examples of the disclosure. In one or more examples, process700can begin at step702, where an indication (such as a determination that user has pushed a button) can be received. Once the indication has been received at step702, the process700can move to step704, where the one or more controllers309of the catheter system operate to close the switch306(bubble generation voltage switch), initiating the bubble generation mode of the pulse generator. Once the switch306has been closed at step704, the process700can move to step706, where a determination can be made as to whether a sufficient bubble (e.g., the size of the bubble meets a threshold size) has been formed in the fluid, according to the examples described above.

In one or more examples, once a determination has been made at step706that a bubble of sufficient, threshold size has been grown, the process700can move to step708, where the arc generation switch308can be closed to initiate the arc generation mode of the pulse generator. Once the switch308has been closed at step708, the process700can move to step710, where a determination can be made as to whether an arc has been generated in accordance with the examples described above. Once a determination has been made at step710that an arc has been generated, the process moves to step712, where the arc generation switch308is opened. Additionally, at step712, the bubble generation switch can be opened (if it has not already been opened) to thereby operate the pulse generator in the charge mode described above.

In one or more examples, the process700can repeated so long as the indication to initiate a shock wave is present. In one or more examples, the process700can repeat itself so long as the mechanical button pushed by a user of the shock wave catheter system engages the switch. In one or more examples, the process700can repeat at a frequency of 1 Hz so long as the user pushes the mechanical button, generating a shock wave at a frequency of once every second. In some examples, the process700can repeat at a frequency of 2 Hz, 3 Hz, 4 Hz, ½ Hz, ¼ Hz, or the like. In further examples, the process700can repeat at a rate that is alternatively synchronized to a patient heart beat—in other words, the heart beat of a patient drives the frequency of process and the implementation of the process does not pace the heart.

Although the pulse generator disclosed herein is discussed in the context of a shock wave catheter system, examples of the disclosure include a pulse generator that can be used with other types of medical devices. The properties of the pulse generator, as shown in any one ofFIGS.3-5, may be adjusted based on the medical device. For example, the amount of time that the first switch and/or second switch electrically couples a voltage source to the electrodes, the amount of voltage generated by a voltage source, etc., may be changed. In some examples, the properties of the pulse generator may be changed by changing a program stored in memory and executed by a processor (e.g., controller309).

In some examples, the pulse generator may be operated for backplating the electrodes, according to examples of the disclosure. The arc generation (discussed above) may cause erosion to the electrodes due to, e.g., current discharge between the electrodes removing material. Erosion of the material reduces the lifetime of the electrodes. Backplating the electrodes can reduce the amount of erosion and/or reverse the amount of material degradation on the surfaces of the electrodes by causing metal to be deposited on the electrode(s).

FIG.8Aillustrates a top view of an example electrode assembly800comprising a first inner electrode804, an insulating layer or sheath806disposed over the first inner electrode804and circumferentially wrapped around an elongate member802(e.g., a catheter with a guidewire lumen), and an outer electrode sheath808disposed over the insulating sheath806. The inner electrode804and the outer electrode808may each be connected to a high voltage pulse generator via a plurality of wires810that may be located within a plurality of longitudinal grooves801along the outer surface of the elongate member802(e.g., a catheter having a guidewire lumen) of the shockwave device. The insulating sheath806may have a first opening807athat is coaxially aligned over the first inner electrode804, and the outer electrode sheath808may have a first opening809athat is coaxially aligned over the first opening of the insulating sheath. Erosion of the electrodes may occur at the edges of the outer electrode808and/or in the corners of the inner electrode804.

FIGS.8B and8Cillustrate cross-sectional views taken along A-A of the example electrode assembly800ofFIG.8A.FIG.8Aillustrates the electrode assembly800when a positive polarity is applied to the backplating operation, andFIG.8Billustrates the electrode assembly800when a negative polarity is applied. A fluid may surround the electrodes804and808, where the fluid may be compatible with the backplating operation. Example fluids may include, but are not limited to, iron salts that are water soluble (e.g., ferrous sulfate solutions), noble metal salts, titanium in salt solution, etc. In some examples, the fluid may comprise two or more biocompatible metals (e.g., silver citrate). In some examples, the fluid is suitable for the backplating operation and bubble generation and additionally does not impede radiographic imaging during IVL procedures. In some examples, one or more parameters (e.g., pH, salt concentrations) of the fluid is adjusted to optimize backplating conditions for the material being plated. Additionally or alternatively, the fluid surrounding the electrodes may comprise a fluid that is compatible with the backplating operation and a fluid that is compatible with the bubble generation. For example, the volume of the fluid surrounding the electrodes may comprise 10-25% of a fluid compatible with backplating and 75-90% of a fluid compatible with bubble generation. In some examples, the fluid is a mixture of one or both of a commercially available biocompatible electroplating solution and a saline solution.

FIG.9Aillustrates an exemplary process for backplating operation when a positive polarity (FIG.8B) is applied for the backplating operation, according to examples of the disclosure. Process900can begin at step902, where a voltage source (e.g., the bubble generation voltage source302, the arc generation voltage source304, or a different voltage source) applies a backplating voltage (e.g., μV) to the electrodes. In some examples, the backplating voltage may be applied across the electrodes. The backplating voltage may be lower than the bubble generation voltage and/or the arc generation voltage. Applying the backplating voltage may generate a spark that jumps from the first wire810A (ofFIG.8B) across a first spark gap812A (ofFIG.8B) (step904). The spark may jump across a second spark gap812B (ofFIG.8B) (step906), and then jumps to the second wire810B (step908). At step910, material deposits on the electrode(s).

In some examples, the backplating operation may deposit metal on both electrodes by switching the polarity of the applied backplating voltage.FIG.9Billustrates an exemplary process for the backplating operation when a negative polarity (FIG.8C) is applied, according to examples of the disclosure. Process950can begin at step952, where a voltage source (e.g., the bubble generation voltage source302, the arc generation voltage source304, or a different voltage source) applies a backplating voltage to the electrodes. Applying the backplating voltage may generate a spark that jumps from the second wire810B (ofFIG.8C) across a second spark gap812B (ofFIG.8C) (step954). At step956, the spark may jump to the first spark gap812A (ofFIG.8C), and at step958, may jump from the first spark gap812A to the first wire810A. At step960, material deposits on the electrode(s).

FIG.10illustrates an example of a computing system1000, in accordance with some examples of the disclosure. System1000can be a client or a server. As shown inFIG.10, system1000can be any suitable type of processor-based system, such as a personal computer, workstation, server, handheld computing device (portable electronic device) such as a phone or tablet, or dedicated device. The system1000can include, for example, one or more of input device1020, output device1030, one or more processors1010, storage1040, and communication device1060. Input device1020and output device1030can generally correspond to those described above and can either be connectable or integrated with the computer.

Input device1020can be any suitable device that provides input, such as a touch screen, keyboard or keypad, mouse, gesture recognition component of a virtual/augmented reality system, or voice-recognition device. Output device1030can be or include any suitable device that provides output, such as a display, touch screen, haptics device, virtual/augmented reality display, or speaker.

Storage1040can be any suitable device that provides storage, such as an electrical, magnetic, or optical memory including a RAM, cache, hard drive, removable storage disk, or other non-transitory computer readable medium. Communication device1060can include any suitable device capable of transmitting and receiving signals over a network, such as a network interface chip or device. The components of the computing system1000can be connected in any suitable manner, such as via a physical bus or wirelessly.

Processor(s)1010can be any suitable processor or combination of processors, including any of, or any combination of, a central processing unit (CPU), graphics processing unit (GPU), field programmable gate array (FPGA), programmable system on chip (PSOC), and application-specific integrated circuit (ASIC). Software1050, which can be stored in storage1040and executed by one or more processors1010, can include, for example, the programming that embodies the functionality or portions of the functionality of the present disclosure (e.g., as embodied in the devices as described above)

Software1050can also be stored and/or transported within any non-transitory computer-readable storage medium for use by or in connection with an instruction execution system, apparatus, or device, such as those described above, that can fetch instructions associated with the software from the instruction execution system, apparatus, or device and execute the instructions. In the context of this disclosure, a computer-readable storage medium can be any medium, such as storage1040, that can contain or store programming for use by or in connection with an instruction execution system, apparatus, or device.

Software1050can also be propagated within any transport medium for use by or in connection with an instruction execution system, apparatus, or device, such as those described above, that can fetch instructions associated with the software from the instruction execution system, apparatus, or device and execute the instructions. In the context of this disclosure, a transport medium can be any medium that can communicate, propagate or transport programming for use by or in connection with an instruction execution system, apparatus, or device. The transport computer readable medium can include, but is not limited to, an electronic, magnetic, optical, electromagnetic, or infrared wired or wireless propagation medium.

System1000may be connected to a network, which can be any suitable type of interconnected communication system. The network can implement any suitable communications protocol and can be secured by any suitable security protocol. The network can comprise network links of any suitable arrangement that can implement the transmission and reception of network signals, such as wireless network connections, T1 or T3 lines, cable networks, DSL, or telephone lines.

System1000can implement any operating system suitable for operating on the network. Software1050can be written in any suitable programming language, such as C, C++, Java, or Python. In various embodiments, application software embodying the functionality of the present disclosure can be deployed in different configurations, such as in a client/server arrangement or through a Web browser as a Web-based application or Web service, for example.

The foregoing description, for the purpose of explanation, has been described with reference to specific embodiments. However, the illustrative discussions above are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations are possible in view of the above teachings. The embodiments were chosen and described in order to best explain the principles of the techniques and their practical applications. Others skilled in the art are thereby enabled to best utilize the techniques and various embodiments with various modifications as are suited to the particular use contemplated. For the purpose of clarity and a concise description, features are described herein as part of the same or separate embodiments; however, it will be appreciated that the scope of the disclosure includes embodiments having combinations of all or some of the features described.

Although the disclosure and examples have been fully described with reference to the accompanying figures, it is to be noted that various changes and modifications will become apparent to those skilled in the art. Such changes and modifications are to be understood as being included within the scope of the disclosure and examples as defined by the claims. Finally, the entire disclosure of the patents and publications referred to in this application are hereby incorporated herein by reference.

It should be noted that the elements and features of the example catheters illustrated throughout this specification and drawings may be rearranged, recombined, and modified without departing from the present invention. For instance, while this specification and drawings describe and illustrate several example electrode assemblies, the present disclosure is intended to include catheters having a variety of electrode configurations. Further, the number, placement, and spacing of the electrode pairs and assemblies can modified without departing from the subject invention.

It will be understood that the foregoing is only illustrative of the principles of the invention, and that various modifications, alterations and combinations can be made by those skilled in the art without departing from the scope and spirit of the invention. Any of the variations of the various catheters disclosed herein can include features described by any other catheters or combination of catheters herein. Furthermore, any of the methods can be used with any of the catheters disclosed. Accordingly, it is not intended that the invention be limited, except as by the appended claims.