Systems for plaque resection and pulsed endovascular lithotripsy and methods of use thereof

Abstract

A system configured to perform plaque resection and pulsed endovascular lithotripsy is provided. Aspects of the system include a console; and a handle, wherein the handle is configured to be interchangeably operably connected to: an atherectomy subsystem and a pulsed endovascular lithotripsy subsystem. The invention further provides a component comprising the system and the subsystem. The system and assembly are suitable for use in a variety of different applications, including combined procedures of plaque resection and pulsed endovascular lithotripsy, as well as balloon angioplasty applications.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of the filing date of U.S. Provisional Patent Application Serial No. 63 / 444,414, filed Feb. 9, 2023, under 35 U.S.C. § 119(e), the disclosure of which is incorporated herein by reference in its entirety. Background of the Invention

[0003] Ischemic heart disease is the leading cause of death globally and is caused by the buildup of atherosclerotic plaques within the human vasculature. Worldwide, these diseases account for 84.5% of cardiovascular deaths and 28.2% of total mortality. Ischemic heart disease develops from a mechanism known as atherosclerosis, which is the accumulation of lipids and calcified substances that leads to stenosis (narrowing) of the arterial lumen. Atherosclerotic plaque buildup can occur in both the coronary arteries and the peripheral arteries. The plaque buildup caused by atherosclerosis restricts blood flow through these arteries and can lead to serious adverse cardiovascular events such as myocardial infarction, amputation, and death. In the early stages of atherosclerosis, the plaques are soft lipids, but over time and with disease progression, these plaques physically harden or calcify. Calcified plaques (CPs) that develop in the innermost layer of the arterial wall are the most common. CPs are caused by the deposition and remodeling of calcium hydroxyapatite, which is a process that mimics bone formation. Blood vessels with CPs exhibit reduced vascular elasticity and impaired vascular perfusion. Due to this reduction in compliance and perfusion, the presence of CPs in the vasculature is associated with an increased risk of death and other adverse events.

[0004] While many patients with CPs are asymptomatic, a significant number of patients develop ischemia-related symptoms and signs and undergo endovascular or surgical repair. Endovascular methods are generally preferred over surgical treatment due to their minimally invasive nature. However, the strength of calcified plaques often poses special challenges to effective endovascular treatment. There are many common endovascular treatment methods for treating CPs. One such method is balloon angioplasty (BA), in which the CP lesion is pre-dilated. During BA, a balloon is advanced to the affected site and inflated to dilate the artery loaded with plaque, thereby restoring normal blood flow. If successful, the pre-dilation step is followed by secondary treatment, such as the application of a drug-coated balloon or stent. For successful pre-dilation, BA must mechanically fracture the CPs to ensure long-term patency or openness of the artery and to restore the elasticity of the surrounding healthy blood vessels. High-pressure, non-compliant balloons are typically used to achieve success. However, due to the strength of the CPs, global balloon inflation is often limited and the CPs remain unbroken.

[0005] Another treatment strategy for fracturing CPs is cutting and scoring balloon angioplasty. Cutting balloons (i.e., balloons surrounded by sharp-tipped metal blades) and scoring balloons (i.e., balloons constrained within a metal cage) are designed to create stress concentrations that rupture the CPs. During balloon inflation, the metal blades or cage can embed in the soft tissue or CPs, leading to serious procedural problems. Adverse outcomes associated with these balloons include restenosis in 20 - 30% of cases and serious adverse events such as vascular perforation, myocardial infarction, or death in 6% of cases.

[0006] Intravascular shock wave therapy uses a low-pressure balloon with a lithotripter embedded that generates shock waves. Clinical trials have demonstrated the short-term efficacy and safety of the lithotripsy device; however, recent case reports have shown that these cavitation explosions >50ATM can lead to dangerous arterial dissections and perforations.

[0007] Another commonly used CP treatment method is atherectomy, which is a technique that uses abrasion, for example, to condition or ablate the CPs. However, atherectomy is more technically challenging and can abrade surrounding healthy tissue in addition to the CPs, potentially leading to long-term vascular damage.

[0008] Other treatment methods combine standard treatment methods to overcome the difficulties of CP strength. One such procedure developed by clinicians is called Rota-Shock (McLaughlin et al., “First United States Experience with Rota-Shock: A Case Series”, Cardiovascular Revascularization Medicine (2022) 40:209 - 213), which is a combination of Boston Scientific's Rotablator TM atherectomy system and Shockwave Medical's intravascular lithotripsy platform. When using the Rotablator TM atherectomy system, a small abrasive burr is first used to create a channel through the stenosis or complete occlusion. Once the channel is created, Shockwave Medical's intravascular lithotripsy balloon is passed through the channel and across the lesion site. The energy of the intravascular lithotripsy is delivered to the surrounding tissue, creating radial fractures in the calcium and enabling the vessel to dilate. While the Rota-Shock method may provide benefits in some cases, this method is cumbersome, time-consuming, and requires the insertion and removal of multiple mechanical systems in the vasculature. Aspects of the present invention address these drawbacks. Summary of the Invention

[0009] A system for performing atherectomy and pulsed intravascular lithotripsy is provided. Aspects of such systems include a console; and a handle, where the handle is configured to be interchangeably operably connected to: an atherectomy subsystem and a pulsed intravascular lithotripsy subsystem. In some embodiments, the handle is operably connected to the atherectomy subsystem. In other embodiments, the handle is operably connected to the pulsed intravascular lithotripsy subsystem. In embodiments, the atherectomy subsystem and the pulsed intravascular lithotripsy subsystem each include an interface configured to be operably connected to an interface of the handle. In some embodiments, the atherectomy subsystem includes: an atherectomy tool, which is a rotational atherectomy tool or an orbital atherectomy tool or a laser tool or an ultrasonic tool or an electrohydraulic lithotripsy (EHL) cavitation emitter tool or a mechanical conduction tool.

[0010] Embodiments of the inventive system also include a rotation assembly configured to convert energy transmitted from the console into rotational energy. In some embodiments, the atherectomy subsystem includes: a lateral transmission assembly configured to propagate the rotational energy from the rotation assembly to the atherectomy tool. In other embodiments, the atherectomy subsystem includes: a sensor configured to sense one or more of current, rotational position, speed, acceleration, temperature, linear position, torque, pressure, or flow.

[0011] Embodiments of the inventive system include a pulsed intravascular lithotripsy subsystem that includes: a proximal connector configured to be operably connected to the handle, a distal balloon, and a catheter, where the distal balloon is operably connected to the catheter and the catheter is operably coupled to the proximal connector. In certain such embodiments, the proximal connector and the connector of the atherectomy subsystem each include the same handle interface.

[0012] Embodiments of the inventive system also include an integrated atherectomy and pulsed intravascular lithotripsy subsystem that includes: an atherectomy subsystem and a pulsed intravascular lithotripsy subsystem. In some embodiments, the pulsed intravascular lithotripsy subsystem includes a guidewire lumen, the atherectomy subsystem includes a lateral transmission assembly that includes a guidewire, and the guidewire is present within the guidewire lumen. In certain such cases, the atherectomy tool is present on the distal region of the guidewire.

[0013] A method for treating diseased blood vessels. The method according to an embodiment of the present invention includes deploying a system according to an embodiment of the present invention such that the atherectomy tool of the system is close to the occlusion of the diseased blood vessel, actuating the system such that the atherectomy tool creates a channel in the occlusion of the diseased blood vessel, guiding the distal balloon of the system through the channel, and actuating the system to impart pulsed energy to the diseased blood vessel. The method according to other embodiments of the present invention includes: introducing a guide wire into the luminal tissue; using the guide wire to introduce the atherectomy tool of the atherectomy subsystem of the system according to an embodiment of the present invention into the luminal tissue; removing the atherectomy subsystem from the luminal tissue; and using the guide wire to introduce the distal balloon of the intravascular pulsed lithotripsy subsystem of the system into the luminal tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1A A schematic diagram of an aspect of a system according to an embodiment of the present invention is provided. Figure 1B A schematic diagram of an aspect of the atherectomy subsystem of a system according to an embodiment of the present invention is provided. Figure 1C A schematic diagram of an aspect of the intravascular pulsed lithotripsy subsystem of a system according to an embodiment of the present invention is provided.

[0015] Figure 2A A schematic diagram of an aspect of another system with a combined tool according to an embodiment of the present invention is provided. Figure 2B A schematic diagram of an aspect of the atherectomy subsystem and the intravascular pulsed subsystem with a combined tool according to an embodiment of the present invention is provided.

[0016] Figure 3A A view of a console according to an embodiment of the present invention is provided. Figure 3B A view of another console according to other embodiments of the present invention is provided.

[0017] Figure 4A A view of a handle according to an embodiment of the present invention is provided; Figure 4B A view of a handle according to another embodiment of the present invention and a view of a connector according to an embodiment of the present invention are provided, showing the releasable and operable interconnection between these elements.

[0018] Figure 5A is a schematic diagram of an elastic conduit (such as an artery) embedded with a hardening material (such as calcified plaque) to be treated by a dynamic balloon angioplasty (DBA) technique and device according to some embodiments of the present teachings. Figure 5B is of an Figure 5A elastic catheter with a DBA angioplasty balloon navigated to the diseased site and pre-pressurized. Figure 5C is a schematic diagram of an Figure 5A elastic conduit with a DBA angioplasty balloon cycled to a low pressure.Figure 5D is a schematic diagram of an elastic conduit having a DBA angioplasty balloon cycled to high pressure Figure 5A . Figure 5E is a schematic diagram of an elastic conduit having a hardened material ruptured according to the principles of the present teachings Figure 5A .

[0019] Figure 6 A description of a pulsed treatment plan according to an embodiment of the present invention is provided DETAILED DESCRIPTION

[0020] Systems and methods for combining two procedures, atherectomy and pulsed intravascular lithotripsy, into a single treatment modality are disclosed herein. In an embodiment, the system of the present invention includes a console; and a handle, wherein the handle is configured to be interchangeably and operably connected to: an atherectomy subsystem and a pulsed intravascular lithotripsy subsystem. In some embodiments, the handle is operably connected to the atherectomy subsystem. In other embodiments, the handle is operably connected to the pulsed intravascular lithotripsy subsystem. Aspects of the present invention also include a method of treating CP by first performing atherectomy and subsequently performing pulsed intravascular lithotripsy. The method of the present invention includes: operably connecting the handle to the atherectomy subsystem and engaging the atherectomy subsystem to perform an atherectomy procedure, and operably connecting the handle to the pulsed intravascular lithotripsy subsystem and engaging the pulsed intravascular lithotripsy subsystem to perform a pulsed intravascular lithotripsy procedure. In further describing aspects of the present invention, its systems and components are first described in more detail and then the methods of using these systems are reviewed

[0021] As described above, the system of the present invention includes a console; and a handle, wherein the handle is configured to be interchangeably operably connected to: an atherectomy subsystem and an intravascular pulsed lithotripsy subsystem. Additionally, in certain embodiments, the handle is operably connected to the atherectomy subsystem, and in other embodiments, the handle is operably connected to the intravascular pulsed lithotripsy subsystem. "Interchangeably operably connected" means that, for example, embodiments of the handle of the present invention include a single interface that is configured such that the same handle interface can be connected to the atherectomy subsystem or can be connected to the intravascular pulsed lithotripsy subsystem. That is, in an embodiment, "interchangeably operably connected" means that the handle can first be operably connected to the atherectomy subsystem such that the system can be used to perform an atherectomy procedure, and after performing that procedure, the handle can be disengaged from that subsystem and then operably connected to the intravascular pulsed lithotripsy subsystem such that the system can be used to perform an intravascular pulsed lithotripsy procedure. In an embodiment, the handle interface can include one or more structural elements (such as shape or depth or other volumetric features), connector elements (such as pneumatic connectors, including for example O-rings and / or bases for O-rings), alignment elements, keying elements, electrical connection elements, etc., wherein the arrangement and shape of these elements of the interface are such that these elements can be aligned with corresponding elements of each of the atherectomy subsystem and the intravascular pulsed lithotripsy subsystem. That is, in an embodiment, each of the atherectomy subsystem and the intravascular pulsed subsystem includes an interface having alignment or other connection features, such as those described above and herein, that correspond to similar features of the handle interface. The interfaces of the handle and each of the subsystems are arranged or otherwise configured such that when the handle is connected to either subsystem, potential energy can be transferred from the handle to the connected subsystem, as described in detail herein.

[0022] Figures 1A through 1C System 100 is depicted, showing a combined atherectomy and intravascular pulsed lithotripsy platform with separate tools. System 100 can also be referred to as a combined atherectomy and intravascular pulsed lithotripsy platform with non-integrated tools. System 100 includes separate tools in part because distal balloon 159 is separate from atherectomy tool 169. That is, when distal balloon 159 and atherectomy tool 169 are present within vessel wall 199, they are not directly connected to each other, such as via catheter 154 or lateral transfer assembly 164 or guidewire 167 or guidewire 157 or other means. The lateral transfer assembly can also be referred to as a lateral transfer element.

[0023] As described herein, the atherectomy subsystem 160 and the intravascular pulsed lithotripsy subsystem 150 are configured such that each subsystem is interchangeably and operably connectable to the handle 111. That is, the system can be configured such that the atherectomy subsystem 160 can be first connected to the handle 111, and then, the intravascular pulsed lithotripsy subsystem 150 can be connected to the handle 111. The handle 111 and the atherectomy subsystem 160 and the intravascular pulsed lithotripsy subsystem 150 are configured such that the handle and each subsystem can be operably connected, subsequently released, and subsequently operably connected. The handle 111 includes interfaces (such as shape interfaces and / or other interlocking element interfaces), such as keying surfaces or alignment features and electrical connectors, which are positioned such that when the handle 111 interfaces with the atherectomy subsystem 160, the handle 111 provides potential energy to the atherectomy subsystem 160, as well as any control or data interconnections, such as electrical connectors, for providing electrical potential to a power circuit (such as a controller), or for sending / receiving sensor data, etc. Similarly, the shape and / or any other interlocking elements of the handle 111 are positioned such that the handle 111 can also interface with the intravascular pulsed lithotripsy subsystem 150, such that the handle 111 can provide potential energy to the intravascular pulsed lithotripsy subsystem 150, as well as any control or data interconnections, etc. In an embodiment, the handle interfaces with the connector 113 of the atherectomy subsystem 160 and the proximal connector 151 of the intravascular pulsed lithotripsy subsystem 150 such that the same handle 111 (and the same console 110) can be used to provide potential energy to each tool of the atherectomy subsystem 160 and the intravascular pulsed lithotripsy subsystem 150. The connectors 113 and 151 can be interchangeably referred to as amplifiers or amplifier assemblies.

[0024] Figures 1A - 1C Schematic diagrams of an atherectomy subsystem 160 and an intravascular pulsed lithotripsy subsystem 150 according to embodiments of the present invention are provided, each connected to a common handle 111 and console 110. As Figure 1A shown, the system 100 includes a console 110 having a potential energy source 121 that is arranged to provide a potential energy output 122 that can vary, such as a predetermined output, a user-set output, or an output controlled by feedback / feedforward. The console 110 can also be referred to as a console assembly or a console subsystem.

[0025] The potential energy source 121 can vary, and examples of potential energy sources include, but are not limited to, electromagnetic (such as voltage or current) potential energy sources or high-pressure gases (such as nitrogen, carbon dioxide, compressed air, or gas mixtures, etc.). The potential energy output 122 can be set to a specific potential energy output 122 (such as voltage or pressure), or another output (such as current or flow rate). This output 122 can be adjusted, for example, by a regulator (as described herein) between minimum and maximum levels (such as, minimum and maximum levels of pressure or voltage or current, etc.), and these levels can be greater than or not greater than the level of the input potential energy source 121.

[0026] In some cases, multiple potential energy sources can be used simultaneously or at different times. For example, multiple potential energy sources can be used through a single console or multiple consoles and / or a single handle or multiple handles. As shown, the potential energy output 122 is transmitted to a handle 111 that includes a switch 141 (such as an electronic and / or mechanical switch, solenoid, etc.). The switch 141 is located within the handle 111. The handle 111 can include multiple output connections, such as connections to an output of a pulsed intravascular lithotripsy subsystem 150 having a distal balloon 159, and / or connections to an output of an atherectomy subsystem 160 having an atherectomy tool 169; or the handle 111 can include a single output connection that is configured such that this single output connection can be operably connected to each of the pulsed intravascular lithotripsy subsystem 150 and the atherectomy subsystem 160. That is, the output of the handle 111 including the switch 141 can first be operably connected to the atherectomy subsystem 160, and when disconnected from the atherectomy subsystem 160, can subsequently be operably connected to the pulsed intravascular lithotripsy subsystem 150; that is, the handle 111 is configured (such as, shaped and / or includes an interlocking device) such that the handle 111 can be interchangeably and operably connected to each of the atherectomy subsystem 160 and the pulsed intravascular lithotripsy subsystem 150.

[0027] The handle 111 may also be referred to as a handle assembly. The handle 111 includes a switch 141 and may be operably connected to amplifier assemblies, such as amplifier assemblies 113, 151 each corresponding to the atherectomy subsystem 160 and the intravascular pulsed lithotripsy subsystem 150, respectively. The amplifier assemblies 113, 151 may also be referred to as amplifiers or proximal connectors or connectors. The amplifier assemblies 151, 113 and the handle assembly 111 are each configured (e.g., shaped and / or include interlocking devices and / or standardized shapes and interconnections) such that the handle assembly 111 can releasably engage with each amplifier assembly 151, 113 (i.e., can be operably connected such that potential energy is transferred from the handle to the amplifier assembly and then disengaged). In some cases, the handle assembly 111 may be reusable (e.g., reused in different patients and / or different procedures), while the atherectomy subsystem 160 and the intravascular pulsed lithotripsy subsystem 150, including the amplifier assemblies 151, 113, are disposable.

[0028] In an embodiment, the handle assembly 111 may be disengaged from, for example, the amplifier assembly 113 so as to subsequently operably connect the handle assembly 111 to, for example, the amplifier assembly 151. For example, the handle assembly 111 may first be operably connected to the atherectomy amplifier assembly 113. That is, an operator of the system 100 may first connect the atherectomy subsystem 160 to the handle 111 such that the atherectomy subsystem 160 is operably connected to the handle 110 and the console 110 to perform an atherectomy procedure. Then, the operator may disengage the handle assembly 111 from the atherectomy amplifier assembly 113 and operably connect the handle assembly 110 to the intravascular pulsed lithotripsy amplifier 151 such that the intravascular pulsed lithotripsy subsystem 150 is operably connected to the handle 111 and the console 110 to perform an intravascular pulsed lithotripsy procedure. That is, although the system 100 includes separate atherectomy and intravascular pulsed lithotripsy subsystems, these subsystems are each connected to a common source of potential energy (i.e., the handle 111, which is itself operably connected to the console 110), providing ease of use for the operator and saving time for combined procedures of atherectomy and intravascular pulsed lithotripsy.

[0029] As described herein, embodiments of the system of the present invention may also include a handle assembly 111, an amplifier assembly 151 configured for the intravascular pulsed lithotripsy subsystem 150, and an amplifier assembly 113 configured for the atherectomy subsystem 160. In these embodiments, the handle assembly 111 and the amplifier assembly 113 may be disengaged from each other so that the handle assembly 111 can subsequently be operably connected to another amplifier assembly, such as the amplifier assembly 151. For example, a clinician may first insert the atherectomy subsystem 160 into a blood vessel 199, connect the atherectomy amplifier 113 to the handle 111, treat a lesion 198, then disconnect the atherectomy subsystem 160 from the handle 11, and then connect the intravascular pulsed lithotripsy amplifier 151 to the handle 111 and treat the lesion 198. In a combined procedure of atherectomy and intravascular pulsed lithotripsy, these steps may be repeated as needed.

[0030] The console 110 may be referred to as a console assembly or a console subsystem. In some embodiments schematically illustrated as Figure 1A in, the system 100 includes a console 110, which may include one or more console units 120; a handle 111, which includes a switch 141; an atherectomy subsystem 160, which includes a connector 113, a rotation assembly 161, a lateral transfer assembly 164, and an atherectomy tool 169; and an intravascular pulsed lithotripsy subsystem 150, which includes a proximal connector 151 and a catheter 154 having a fluid passage connecting the distal and proximal regions of the catheter 154 to a distal balloon 159. The switch may be referred to as an oscillator 141. In an embodiment, the switch 141 is located in the handle 111. In an embodiment, the atherectomy subsystem 160 includes a rotation assembly 161 operably connected to the connector 113, and the connector 113 is configured to transfer potential energy from the handle 111 to the rotation assembly 161.

[0031] The handle 111 including the oscillator 141 is connected to the atherectomy subsystem 160 for transmitting pulsed energy (i.e., second pulsed energy) or static energy to the atherectomy tool 169 via the connector 113, the rotation assembly 161, and the lateral transfer assembly 164. As shown by arrow 168, the atherectomy subsystem 160 is also configured to translate in the distal and proximal directions. The handle 111 including the oscillator 141 is connected to the intravascular pulsed lithotripsy subsystem 150 for transmitting pulsed energy (i.e., second pulsed energy) or static energy to the distal balloon 159 via the proximal connector 151 and the catheter 154 to pressurize the balloon 159.

[0032] The console component 110 of system 100 includes a single console 120. The console 120 may also be referred to as a console unit. However, embodiments of the system of the present invention may include one or more console units. When multiple console units are employed, these console units may be combined into a single physical component (i.e., a housing) or divided into multiple housings, such as one housing for each console unit. In some such cases, the console units are configured to operate independently of each other, i.e., they can be independently controlled regardless of whether the console units are present in a single housing or multiple housings. In some cases, a first console unit may be used to provide potential energy to the atherectomy subsystem 160, and a second console unit may be used to provide potential energy to the intravascular pulsed lithotripsy subsystem 150.

[0033] The console unit 120 includes a potential energy source 121 for generating or providing energy that is transmitted through a potential energy regulator 122 for modulating the transmitted potential energy to a handle 111 that includes a switch 141. In some embodiments, the potential energy source 121 may be separate from the console unit 120 and the console component 110. That is, the potential energy source 121 may be operatively connected to the console component 110 but not enclosed within the same housing as the console component 110. The output of the potential energy source 121 may include regulated potential energy 122 or unregulated potential energy, such as potential energy from a high-pressure fluid or voltage or current. The potential energy regulator 122 may be used to modify the potential energy output from the potential energy source 121 into a form that can be transmitted and further manipulated by the switch 141. The switch 141 may also be referred to as an oscillator. The switch 141 is capable of generating pulsed energy from the energy transmitted by the potential energy source 121 for output to the subsystem.

[0034] In some embodiments, multiple console units can be included in console assembly 110 and can operate substantially in parallel (i.e., independently) to generate multiple potential energy outputs 122 for transmission to multiple handles each including an oscillator, or in other cases, to a single handle having multiple oscillators. In some embodiments, in the treatment of tissue (such as treatment of cardiovascular tissue, such as tissue having calcified plaque deposits) that involves applying energy in different configurations (such as pulsed energy), multiple console units 120 can be configured to generate multiple potential energy outputs 122, for example, where the atherectomy subsystem and the pulsed intravascular lithotripsy subsystem are configured to receive potential energy in different forms (such as electrical potential and high-pressure gas, respectively) and / or different frequencies, duty cycles, and / or amplitudes. In these cases, the different potential energy outputs 122 can be applied to the tissue (such as cardiovascular tissue) individually, or at different times, for example, via the atherectomy subsystem or the pulsed intravascular lithotripsy subsystem. That is, one potential energy source can be operably connected to system 100 at a first time for an atherectomy procedure, and subsequently, another potential energy source can be operably connected to system 100 at a second time for a pulsed intravascular lithotripsy procedure. In other cases, the potential energy outputs from multiple console units are combined together, for example, at a single handle. In still other cases, in the treatment of tissue (such as cardiovascular tissue) (such as treatment of tissue having calcified plaque deposits) that requires applying different forms of energy, multiple console units are configured to generate multiple potential energy outputs including different forms of potential energy (such as high-pressure fluid or voltage potential). For example, embodiments can include an atherectomy subsystem that utilizes a rotational tool and one or more of a laser tool, an ultrasonic tool, a shock wave lithotripsy (EHL) cavitation emitter tool, or a mechanical conduction tool, etc.

[0035] The console assembly 110 also includes controllers 130a, 130b, which in each case are configured to receive inputs, such as control and / or data input signals, such as sensor data signals, from at least one of the console assembly 110, the energy source 121, the handle 111, the switch 141, the atherectomy subsystem 160, the amplifier 113, the intravascular pulsed lithotripsy subsystem 150, the proximal connector 151, or other aspects of the system 100. In the depicted embodiment, controller 130a receives inputs from the intravascular pulsed lithotripsy subsystem 150. That is, controller 130a receives input signals from sensors 152, 153 of the intravascular pulsed lithotripsy subsystem 150 via electrical connector 155. Sensors 152, 153 can include any sensors configured to sense any relevant characteristics of the intravascular pulsed lithotripsy subsystem 150 that can be detected. For example, sensor 152 can include a pressure sensor configured to measure the pressure within the intravascular pulsed lithotripsy subsystem 150, such as the pressure in the fluid passage of catheter 154 or the pressure of aspects of the distal balloon 159 (such as an angioplasty balloon), and sensor 153 can include a volume sensor (e.g., a displacement sensor integrated into the proximal connector 151, such as a Hall sensor) configured to measure the volume of fluid present in or displaced into, for example, the distal balloon 159. That is, in this embodiment, operation of the proximal connector 151 displaces fluid into the catheter 154 and / or the distal balloon 159.

[0036] Similarly, the controller 130b receives inputs from the atherectomy subsystem 160. That is, the controller 130b receives input signals from sensors 162, 163 of the atherectomy subsystem 160 via the electrical connector 165. The sensors 162, 163 can include any suitable sensors configured to sense any relevant characteristics of the atherectomy subsystem 160 that can be detected. For example, the sensors 162, 163 can include sensors configured to sense the rotational position, speed, acceleration, temperature, linear position, torque, or pressure of aspects of the lateral transmission assembly 164 or the atherectomy tool 169, and / or can include sensors configured to sense the current associated with interfacing the atherectomy subsystem 160 with the occlusive lesion 198, or to sense the current response of the atherectomy subsystem 160 penetrating into the occlusive lesion 198; and / or the sensors 162, 163 can be configured to sense one or more of the rotational position, speed, acceleration, temperature, linear position, torque, pressure associated with the rotational assembly 161 or the atherectomy tool 169. In some cases, the sensors 162, 163 can include optical encoders or rotary encoders or other mechanisms configured to detect rotational motion or rotational displacement (such as position, speed, acceleration, or jerk) of aspects of the atherectomy subsystem.

[0037] In some cases, one or both of the sensors 162, 163 are configured to measure torque, such as the torque applied by the atherectomy tool 169 to the lesion 198. For example, such a torque sensor can be configured to sense the magnitude of the resistance encountered by the atherectomy tool when engaging or advancing into the lesion 198. The change in torque measured by such a sensor can indicate the degree to which the atherectomy tool 169 has penetrated into the lesion 198. For example, a sudden drop in the amount of torque applied indicates that the atherectomy tool 169 may no longer be abrading aspects of the lesion 198 (e.g., no longer abrading the calcified plaque of the lesion 198).

[0038] Inputs from sensors, such as sensors 162, 163, can be used to control various aspects of system 100, such as various aspects of atherectomy system 160. For example, in an embodiment, the acceleration and / or rotational speed of the atherectomy tool 169, detected by one or more sensors, can be used to establish a control loop to control configurable aspects of the subsystem, such as the rotational speed of the atherectomy tool or the lateral movement (e.g., distal advancement) of the atherectomy tool. Such control can take the form of feedback or feedforward control techniques. In some examples, a PID control loop mechanism is applied based on data detected by one or more sensors, such as sensors 162, 163. When the rotation assembly 161 operates based on electric potential, control strategies of a control loop such as the above can be used in combination with controlling the voltage or current applied to the rotation assembly 161. In some cases, there is a sensor in system 100 that is configured to detect the lateral movement of the lateral transfer assembly 164 (e.g., in the direction of arrow 168). Any suitable position sensor can be used for this purpose, such as an optical encoder. In some cases, sensors of interest include sensors configured to detect fluid pressure, such as for sensing the pressure within system 100 or within blood vessel 199.

[0039] In some examples, controllers 130a, 130b can be configured to receive inputs from multiple sensors, including sensors configured to measure any relevant aspects of system 100 or the application environment of system 100 (such as pressure sensors, temperature sensors, volume sensors, displacement sensors, etc.), and controllers 130a, 130b can be configured to collect data from any location throughout system 100, including, for example, one or more locations of system 100, such as the atherectomy tool 169, the lateral transfer assembly 164, the connector 113, the rotation assembly 161, the distal balloon 159, the catheter 154, the proximal connector 151, the handle 111, the oscillator 141, the console unit 120, or the console assembly 110. Controllers 130a, 130b are located within the console assembly 110. However, in other embodiments, for example, controllers 130a, 130b can be present within the handle 111 or within the intravascular lithotripsy subsystem 150 or within the proximal connector 151 or within the atherectomy subsystem 160 or within the amplifier 113 or within the rotation assembly 161. Embodiments of the system can include one or more controllers, such as one, two, three, four, five, or more controllers, and these controllers can be located in the same aspect or subsystem of the system or can be distributed at different locations throughout the system.

[0040] Generally, in embodiments, the sensors can be configured at any desired location of the system 100 to collect any desired information regarding the use of the system 100, such as information related to a treatment procedure. In other cases, the controllers 130a, 130b are configured to receive inputs from user inputs (such as buttons or switches for specifying treatment options), such as system pressure, frequency, duty cycle, and the like.

[0041] The controller 130a receives an input from the pressure sensor 152 of the pulsed intravascular lithotripsy subsystem 150 and, at least in part based on the input, generates a control signal for controlling aspects of the console assembly 110, such as the amplitude of the potential energy output 122, i.e., via an active regulator for adjusting the amplitude of the potential energy output 122 (e.g., the output pressure). Similarly, the controller 130b receives an input from the sensor 162 of the atherectomy subsystem 160 and, at least in part based on the input, generates a control signal for controlling aspects of the console assembly 110, such as the amplitude of the potential energy output 122, i.e., via an active regulator for adjusting the amplitude of the potential energy output 122 (e.g., the output pressure). In an embodiment, the controllers 130a, 130b can be combined into a single controller 130; that is, such that the controller 130 includes logically distinct (but not physically distinct) controllers 130a, 130b.

[0042] The output of the console assembly 110 is operatively connected to the handpiece 111 that includes the oscillator 141 such that the energy transmitted from the potential energy source 121 of the console unit 120 (i.e., the regulated potential energy output 122) is transmitted to the oscillator 141 of the handpiece 111. The oscillator 141 is configured to generate pulsed or static energy (e.g., energy with a varying amplitude over a period of time or energy with a constant amplitude over a period of time) based on the energy transmitted from the potential energy source 121 (i.e., the regulated potential energy output 122). In some cases, the oscillator 141 can include a solenoid valve that is configured to either allow or interrupt the transmission of energy to the pulsed intravascular lithotripsy subsystem 150 and / or the atherectomy subsystem 160. In other cases, the oscillator 141 can include any suitable electrical switch (such as an electric solenoid), optical switch, or mechanical switch known in the art. As described herein, the behavior of the oscillator 141 can be controlled by, for example, the controllers 130a, 130b, based on any desired feedback, such as feedback from the system 100 or an external signal, such as an input from an operator (e.g., a clinician) of the system 100.

[0043] Controllers 130a, 130b are shown as being connected to oscillator 141 within handle 111. In some cases, oscillator 141 may be configured such that aspects of the behavior of oscillator 141 (such as oscillation frequency and / or duty cycle) may be controlled by controllers 130a, 130b. For example, controllers 130a, 130b may control the position (such as open or closed position) or other aspects of the behavior (such as frequency or duty cycle) of the solenoid of oscillator 141.

[0044] Figure 1B There is provided Figure 1A a more detailed view of certain aspects of the atherectomy subsystem 160 of system 100 that includes amplifier 113 and rotational assembly 161. Now referring Figure 1A and 1B , atherectomy subsystem 160 is configured to remove or disrupt occlusion 198 in blood vessel 199, such as a calcified plaque deposit or a chronic total occlusion (CTO), and the subsystem includes a lateral transmission assembly 164 having a distal end and a proximal end, the distal end being configured to be inserted into blood vessel 199. In some cases, the systems of the present invention are capable of treating calcified plaque deposits in which calcification prevents or inhibits compression of the plaque deposit. Atherectomy subsystem 160 also includes an atherectomy tool 169 that includes a rotational cutting mechanism located at the distal end of lateral transmission assembly 164 for cutting and removing occlusion 198 of blood vessel 199. Atherectomy tool 169 may include, for example, a grinding head. Atherectomy subsystem 160 also includes amplifier 113 and rotational assembly 161, which are configured to be operatively connected to the potential energy source 121 of handle 111 and console 110. Connector 113 may also be referred to as an amplifier or a proximal connector. Connector 113 is configured to physically connect to the output of handle 111 and transmit the potential energy received therefrom to rotational assembly 161. In some cases, connector 113 is merely a through device that is configured to transmit the potential energy received from handle 111 to rotational assembly 161. Rotational assembly 161 is configured to be operatively connected to the proximal end of lateral transmission assembly 164 to provide rotational power to atherectomy tool 169.

[0045] The atherectomy subsystem 160 includes a connector 113 connected to the handle 111. In an embodiment, the connector 113 may include a through device. That is, the connector 113 may be configured to allow potential energy (such as pressurized gas or electric potential, etc.) to be transmitted through the connector 113 to the rotating assembly 113. In some examples, the connector 113 is configured to allow pressurized gas to enter the rotating assembly 161 through the connector 113, so that the pressurized gas is used to power the rotation and / or orbital motion and / or lateral translation of the atherectomy tool 169 via the rotating assembly 161. In other cases, the connector 113 is configured to allow electric potential energy to enter the rotating assembly 161 through the connector 113 and to power the motion (such as rotation and / or orbital motion and / or lateral translation) of the atherectomy tool 169 again. In certain cases, the connector 113 is used to provide an interface (such as a standard or unified or modular interface) between the rotating assembly 161 and the output of the handle 111. For example, the handle 111 may be configured to include only a single output for transmitting potential energy to the distal aspect of the system 100, and the output of the handle 111 may be configured to, for example, include a shape and / or other interlocking features that enable it to be operably connected to the rotating assembly 161 and the proximal connector 151 of the intravascular pulsed lithotripsy subsystem 150. In certain cases, the handle and the connector include an interface that enables their use such that: the connector 113 of the atherectomy subsystem 160 is first operably connected to the output of the handle 111, then disconnected from the handle 111, and then the proximal connector 151 of the intravascular pulsed lithotripsy subsystem 150 is operably connected to the output of the handle 111.

[0046] Advantages of embodiments of the present invention over conventional methods of atherectomy and / or lithotripsy are at least reflected in that each of the atherectomy subsystem 160 and the intravascular pulsed lithotripsy subsystem 150 can be operably connected to a single handle 111. That is, using a single handle 111 and the console 120, each of the atherectomy subsystem 160 and the intravascular pulsed lithotripsy subsystem 150 is respectively operably connected to the single handle 111 and the console 120, simplifying and streamlining the performance of the combined procedure of atherectomy and intravascular pulsed lithotripsy.

[0047] The atherectomy subsystem 160 further includes a rotating assembly 161, which is operably connected to the atherectomy tool 169 via a lateral transmission element 164. The rotating assembly includes, for example, a rotary cutting mechanism and is configured to control the rotation and / or orbital speed, direction, acceleration, etc. of the rotary cutting mechanism 169, as well as to recover exhaust gas.

[0048] The atherectomy subsystem 160 may also include a visualization mechanism, such as a fluoroscopy-based or ultrasound-based mechanism, which is connected to a control unit (such as an external control unit or a unit configured to visualize aspects of the system 100), or connected to a console having a display (such as Figure 3A the display 330a of the console 300a as shown), for visualizing the distal end of the lateral transmission element 164 or the atherectomy tool 169 during an atherectomy procedure, i.e., for visualizing aspects of the lesion 198 or the blood vessel 199, and for visualizing the position of the atherectomy tool 169 relative to aspects of the lesion 198 or the blood vessel 199. The lateral transmission element 164 and / or the atherectomy tool 169 may include radiopaque markers at any suitable location (such as in the distal region or at the distal end) configured to facilitate such visualization. In an embodiment, the operator of the system can observe X-ray imaging when performing an atherectomy procedure using the system embodiment to visualize the atherectomy tool relative to the lesion and the efficacy of the procedure. In some cases, feedback, such as visual, auditory, tactile, etc. (such as vibration of the handle), may be provided to the operator to indicate surgical features, such as whether the atherectomy tool has engaged or passed through the lesion.

[0049] As described herein, the lateral transmission element 164 may include, for example, a catheter or a guide wire or a combination thereof. The rotation assembly 161 may be attached to the proximal end of the lateral transmission element 164 and is also configured to control the position and orientation of the distal end of the catheter 164 within the blood vessel, e.g., configured to translate the atherectomy tool 169 in the distal direction to further engage the occlusion 198. The lateral transmission element 164 of the atherectomy subsystem 160 includes a lumen 166 that extends through the lateral transmission element 164 from the proximal region to the distal region of the lateral transmission element 164 for aspirating any debris of the occlusion 198 removed from the blood vessel 199, e.g., by applying a vacuum pressure to aspirate such debris. Figure 1B Cross-sections A and B as shown illustrate the cross-sections of the lateral transmission element 164 and the atherectomy tool 169 at positions A and B of the lateral transmission element 164. In cross-sections A and B, the lateral transmission element 164 of the atherectomy subsystem 160 is depicted as a braided shaft with a lumen 166. In other embodiments, the lateral transmission element 164 need not be braided and may or may not include multiple constituent fibers. When the lumen 166 is present, a support member (such as a guide wire, etc.) may be present within the lumen 166 over all or part of the length of the lateral transmission assembly to provide further support for the atherectomy tool 169. Some embodiments may include a solid shaft for the lateral transmission assembly 164, in which case there is no lumen 166.

[0050] The atherectomy subsystem 160 also includes means for detecting and reporting the progress of the atherectomy procedure. Such means can include one or more pressure sensors or torque sensors or occlusion sensors or current sensors, which are connected to a controller, where such means can be configured to detect the degree to which the atherectomy tool 169 penetrates the lesion 198 (such as a chronic total occlusion).

[0051] As described herein, cross-sectional views A and B depict cross-sections of the lateral transmission element 164 at the cross-sections labeled A and B. At cross-section A, the lateral transmission element 164 and the lumen 166 are shown. At cross-section B, the lateral transmission element 164 with the lumen 166 is shown, as well as a cross-section of the abrasive and / or adhesive material 169a that extends radially outward from the lateral transmission element 164 to form the atherectomy tool 169. In this case, the rotating abrasive head is configured to drill into the lesion and expand the diameter of the lesion, such as the lesion 198 within the blood vessel 199.

[0052] The atherectomy subsystem 160 is operated by inserting the distal end of the atherectomy subsystem 160 (i.e., the distal end of the lateral transmission element 164 and the atherectomy tool 169) into the blood vessel 199, where the atherectomy tool 169 cuts and removes the occlusive material 198, such as calcified plaque, from the blood vessel 199. The removed material can be aspirated through the lumen 166, discharged from the blood vessel 199, and discharged outside the subject's body, while the progress of the atherectomy procedure can be monitored and reported by the control unit. Visualization means, such as a fluoroscopy-based means or an ultrasound-based means, allows an operator (such as a clinician, physician, or other operator) to observe the distal end of the lateral transmission element 164 or the atherectomy tool 169 during the procedure, and the rotation assembly 161 allows the operator to control the position and orientation of the distal end of the lateral transmission element 164 or the atherectomy tool 169. For example, aspects of the atherectomy subsystem can include radiopaque markers.

[0053] The amplifier 113 of the atherectomy subsystem 160 is releasably connected to a handle 111 including an oscillator 141 and a console 110 having a potential energy source 121. The potential energy source 121 provides appropriate energy for a rotating assembly 161 to rotate an atherectomy tool 169 by means of an essential oil lateral transmission element 164. The connector 113 receives the regulated potential energy, such as voltage, pressure, or in other cases, current or flow rate, from the handle 111 and transfers the energy to the rotating assembly 161. In some cases, the atherectomy control unit converts this energy into rotational energy. In some cases, for example, when the handle 111 transfers potential energy in the form of pressurized gas, the amplifier 113 receives the exhaust gas from the rotating assembly 161 and conveys it back to the console 110 for release into the atmosphere. In some cases, the amplifier 113 is connected to various sensors present on the atherectomy control unit.

[0054] The rotating assembly 161 of the atherectomy subsystem 160 is an integral part of the overall system design and can be configured to be capable of precisely controlling the position and orientation of the distal end of the lateral transmission element 164 within the blood vessel 199 and relative to the occlusion 198, that is, precisely controlling the position and orientation of the atherectomy tool 169 within the blood vessel 199 and relative to the occlusion 198. The rotating assembly 161 can be designed to allow manual and / or automatic control of a linear platform or a thruster that is responsible for positioning and orienting the distal end of the lateral transmission element 164 or the lateral position of the atherectomy tool 169 (i.e., in the direction of arrow 168).

[0055] The linear platform within the rotation assembly 161 can be powered by a motor and / or a pneumatic device and / or manually controlled by an operator of the system 100 to provide smooth and precise movement to the distal end of the lateral transfer element 164 or the atherectomy tool 169. The linear platform can be programmed in a limited manner to ensure that the distal end of the lateral transfer element 164 or the atherectomy tool 169 does not extend beyond a certain range, thereby helping to maintain the safety and efficacy of the atherectomy procedure. Such a linear platform can include one or more sensors for detecting the linear movement of the atherectomy tool 169 or can include one or more visual references for indicating the linear movement of the atherectomy tool 169. In embodiments, in some cases, the linear movement of the atherectomy tool 169 measured or indicated on the linear platform can be evaluated or compared in real time with the visualization or measurement results of aspects of the lesion 198 during the procedure. Such a comparison enables detection of whether the distance by which the atherectomy tool 169 is translated by the linear platform is equal to or exceeds the visualized or measured depth of the lesion 198. Such a measurement result or reference distance can be used to determine whether the atherectomy tool 169 has penetrated the lesion 198. In embodiments, the linear platform can be configured such that the linear platform moves the rotation assembly 161. In some embodiments, the linear platform can be configured such that the linear platform moves the motor of the rotation assembly 161 responsible for rotating the lateral transfer element 164, and the motor itself is fixed to the lateral transfer element 164. The rotation assembly 161 can be configured to clamp or be fixed to the lateral transfer element 164 such that the linear platform moves both the rotation assembly 161 and the lateral transfer element 164 simultaneously to advance the atherectomy tool 169. In cases where the linear platform is configured to allow manual control of the lateral (i.e., longitudinal) movement of the atherectomy tool, the manual linear platform can take the form of a syringe-like structure, where, for example, once manual force is applied, the rotation assembly 161 is advanced forward relative to the outer housing.

[0056] To ensure accurate positioning of the distal end of the lateral transfer element 164 or the atherectomy tool 169, the rotation assembly 161 and other aspects of the atherectomy subsystem 160 can be equipped with various feedback sensors. These sensors provide real-time information on the position, orientation, and movement of the distal end of the lateral transfer element 164 or the atherectomy tool 169, enabling the control unit to make any necessary adjustments to the position and orientation of the distal end of the lateral transfer element 164 or the atherectomy tool 169.

[0057] The position of the atherectomy tool 169 can be guided using various parameters, such as absolute or relative changes in blood vessel flow or pressure, or based on the rotational characteristics of the lateral transmission element 164, such as torque, speed, position, and acceleration. The control unit can utilize this information to optimize the performance of the atherectomy subsystem 160, ensuring that the occlusion is removed from the blood vessel as effectively, efficiently, and safely as possible.

[0058] The atherectomy tool 169 is a grinding head with a diameter of 0.1 mm to 5 mm and a length of 1 mm to 50 mm. In cases where the atherectomy tool 169 includes a grinding head, it can be eccentric or concentric and have a substantially circular cross-section, as Figure 1B shown by cross-section B of tool 169 therein. In embodiments for treating passable but stenotic lesions, the atherectomy tool 169 can include a grinding head located or mounted 1 mm to 15 mm from the distal end of the lateral transmission element 164. In embodiments for treating non-passable lesions, the atherectomy tool 169 can include a grinding head located or mounted 0 mm to 20 mm from the distal end of the lateral transmission element 164.

[0059] The atherectomy tool 169 and other aspects of the atherectomy subsystem 160 (such as the rotation assembly 161) can be configured such that the atherectomy tool 169 rotates in an orbital motion and / or a rotational motion. In some cases, the mechanics of the rotation are based on speed, direction, pulsatility (i.e., pulse), or rotational acceleration, drive shaft configuration, internal mandrel, or guide wire, or the position, orientation, mass, or bias of the atherectomy tool 169. As described herein, the atherectomy tool 169 can be, for example, a grinding head. In embodiments, the mechanical structure of the atherectomy subsystem 160 or the atherectomy tool 169 can be controlled to optimize the cutting aspect of the atherectomy procedure. In embodiments, the combination of both the rotational and orbital motion of the atherectomy tool has the effect of providing protection in terms of only disrupting the lesion tissue and preventing the disruption of healthy tissue when using the atherectomy tool. In these cases, the rotational and orbital speeds or other mechanical characteristics (such as orbital diameter, etc.) can be selected or otherwise configured such that the grinding aspect of the tool can engage the lesion tissue, which includes relatively hard calcified plaque; however, when this grinding aspect accidentally contacts healthy tissue (such as lumen wall tissue), for example, due to the relative elasticity of this healthy tissue, the grinding aspect of the atherectomy tool cannot engage this tissue, thereby minimizing accidental damage to healthy tissue. This combination of the rotational and orbital motion of the atherectomy tool provides an advantage of the embodiments of the present invention over the prior art, at least in terms of providing the above-mentioned safeguard in preventing damage to healthy tissue (such as the blood vessel wall 199) in the embodiments of the present invention.

[0060] In an embodiment, the atherectomy tool 169 includes any abrasive, binder, or mixture for generating an abrasive material. Abrasives of interest include diamond, quartz, alumina, silicon carbide, zirconia, ceramic alumina, etc. Binder materials of interest include any vitreous or resinous binder. In an embodiment, the abrasive used to form the atherectomy tool 169 is present in a specific diameter that produces a successful abrasive effect on calcified tissue, such as lesion 198, as Figure 1B the specified diameter of the atherectomy tool 169 shown in cross-section B.

[0061] In an embodiment, the lateral transmission element 164 configured to transmit energy to the atherectomy tool 169 includes a suitable braided material (such as nitinol, stainless steel, titanium, platinum, aluminum, etc.). Lateral transmission elements of interest can be produced with or without a core and can include external and / or internal lubricating coatings, such as a silicone rubber coating or a biocompatible lubricating coating. Lateral transmission elements of interest can be single filet (including a single wire, e.g., an arrangement including a single wire) or multi-filet (including multiple wires, e.g., a braid including multiple wires). Lateral transmission elements of interest can be configured to transfer rotational energy from a relatively proximal position of the lateral transmission element to its relatively distal position. For example, the lateral transmission element can be configured to avoid or resist twisting or kinking when it rotates. That is, the lateral transmission element can be configured to resist its own twisting or winding or kinking when it rotates. In other words, the lateral transmission element can be configured to have sufficient rigidity such that it can transfer rotational energy from a relatively proximal region of the lateral transmission element to a relatively distal region.

[0062] Lateral transmission assemblies of interest can have any suitable length, diameter, and shape, for example, having an outer diameter of 0.002 inches to 0.032 inches. In some cases, the length of the lateral transmission assembly is 10 cm to 5 m, such as 100 cm to 300 cm. The lateral transmission assembly can also be referred to as a lateral transmission element. In embodiments where there are lumens (such as for delivering a guide wire) present within the lateral transmission element, the inner diameter of embodiments of the lateral transmission element can be 0.003 inches to 0.087 inches. As described above, lateral transmission elements of interest (such as the lateral transmission element 164) can be configured to produce an eccentric or concentric atherectomy tool 169. In some cases, the atherectomy tool is formed by coating regions of the lateral transmission element 164 with an abrasive material and / or a binder material and / or an abrasive and / or a mixture thereof. In embodiments of the lateral transmission element, metal particles can be electroplated at one or more selective locations outside the lateral transmission element 164 (such as at or around the distal region of the lateral transmission element 164).

[0063] As described herein, the atherectomy subsystem 160 includes an atherectomy tool 169. The atherectomy tool 169 can be any suitable tool for conditioning the lesion 198 or drilling into the lesion 198 such that the intravascular pulsed lithotripsy subsystem 150 can be used to create a fissure (e.g., along the length of the lesion 198) in the lesion 198. That is, the atherectomy tool 169 can be any suitable tool for shaping the lesion 198 such that the distal balloon 169 of the intravascular pulsed lithotripsy subsystem 150 can be positioned within the lesion 198 to enable the provision of intravascular pulsed lithotripsy treatment.

[0064] Examples of atherectomy tools include rotational, orbital, laser, ultrasonic, electrohydraulic lithotripsy (EHL) cavitation emitters, or mechanical conduction tools, among others. In some cases, the atherectomy subsystem 160 includes a guidewire 167 and utilizes the mechanical conduction of the guidewire 167 to create a hole through the occlusion or lesion or chronic total occlusion 198.

[0065] Depending on the type of occlusion 198 and the type of atherectomy tool 169 employed, the atherectomy tool can be configured to grind within the lesion or through the lesion. In some cases, the atherectomy tool is configured to create a new passage within the occlusion or drill into the occlusion. In an embodiment, the atherectomy tool 169 is a grinding head, such as a milling grinding head. As described above, the atherectomy subsystem 160 can be used to create a passage, hole, or other space within a lesion, occlusion, or other obstruction (such as a lesion including a calcified plaque) of vascular or luminal tissue such that the distal balloon 159 of the intravascular pulsed lithotripsy subsystem 150 can be positioned within the new passage to further disrupt the lesion 198. That is, the atherectomy subsystem 160 can be employed to create a volume in which the distal balloon 159 can be accommodated within the lesion to provide intravascular pulsed lithotripsy treatment to further disrupt the lesion.

[0066] Referring again to Figure 1A, on the right hand side of the figure, two representations of the same vessel wall 199 with the same occlusion or lesion 198 are depicted. The vessel wall 199 with the occlusion or lesion 198 is the same in the top and bottom representations and is duplicated to show how each of the atherectomy subsystem 160 and the intravascular pulsed lithotripsy subsystem 150 interfaces with the same vessel wall 199 with the same occlusion and lesion 198. As described herein, the occlusion or lesion 198 (e.g., chronic total occlusion) may include calcified plaque (CP). In some embodiments, the atherectomy subsystem 160 further includes one or more sensors, such as sensor 162, which is configured to sense electrical changes (e.g., current or electric potential), or sense mechanical changes, such as changes in the speed or the applied torque of the atherectomy tool due to penetration of the atherectomy tool 169 into the occlusion 198.

[0067] As described herein, the atherectomy subsystem 160 of the system 100 includes a connector 113 and a rotation assembly 161. The rotation assembly 161 is operably connected to the console unit 120 via the connector 113 and the handle 111 and is configured to generate rotational energy using the potential energy 122 transmitted from the console unit 120. That is, the rotation assembly 161 is configured to convert the energy transmitted from the console unit 120 into rotational energy for use by the atherectomy tool 169 via the handle 111 and the connector 113. The rotation assembly 161 may include a motor (e.g., a pneumatic motor or a turbine motor, or an electric motor). In some cases, the rotation assembly 161 and the connector 113 are configured such that the rotation assembly 161 draws electric potential from the handle 111 via the connector 113.

[0068] As described herein, the atherectomy subsystem 160 of the system 100 includes a lateral transmission assembly 164. The lateral transmission assembly 164 is configured to propagate rotational energy from the rotational assembly 161 to the atherectomy tool 169 such that the atherectomy tool 169 can be used to create a hole or bore or otherwise disrupt the occlusion 198 such that the distal balloon 159 of the intravascular lithotripsy subsystem 150 can then be inserted into the lesion 198. The lateral transmission assembly 164 includes a flexible drive shaft for propagating rotational energy to the atherectomy tool 169. The lateral transmission assembly 164 can be configured to be flexible enough to pass through a blood vessel to the occlusion while also being rigid enough to transmit rotational energy without causing the lateral transmission assembly to distort or kink. The lateral transmission assembly 164 is located distal to the rotational assembly 161 and proximal to the atherectomy tool 169. The lateral transmission assembly 164 includes a guidewire lumen in which there is a guidewire 167, which is used in part to guide the atherectomy tool 169 into the occlusion 198 within the blood vessel 199 and in part to provide stability to the lateral transmission assembly 164 while propagating rotational energy to the atherectomy tool 169.

[0069] In some cases, the lateral transmission assembly can include a fluid bearing that is configured in part to dissipate heat, e.g., heat caused by rotation of one or more aspects of the lateral transmission assembly 164, e.g., rotation of a guidewire present in a fluid, or rotation of a catheter about a guidewire present in a fluid, etc.

[0070] An embodiment of the atherectomy subsystem 160 includes a pusher integrated as part of the rotational assembly 161 that is configured to advance and retract the atherectomy tool 169 in distal and proximal directions. This distal and proximal advancement and retraction is represented by arrow 168, which shows how the distal tool 169 is advanced toward and retracted from the occlusion 198. In some cases, the pusher is configured to drive the atherectomy tool 169 into and out of the occlusive lesion 198 in a pulsed manner; i.e., to peck at one or more surfaces of the occlusion 198 with the atherectomy tool 169.

[0071] Now refer to Figure 1C , which provides a more detailed view of certain aspects of the intravascular lithotripsy subsystem 150 of the system 100. Now refer to Figure 1A and Figure 1C, the intravascular pulsed lithotripsy subsystem 150 includes a proximal connector 151 having a proximal port 151a for operably connecting to the pneumatic output of the handle 111, a proximal flexible tube 151c coupled to the distal port 151b of the proximal connector 151; a distal catheter shaft 154 having an angioplasty balloon 159, such as a composite balloon, at its distal end; and a Y-connector 156 that connects the distal end of the proximal flexible tube 151c to the proximal end of the distal catheter shaft 154. The proximal connector 151 may also be referred to as a connector or an amplifier. An optional valve 156a located between the distal end of the proximal flexible tube 151c and the Y-connector 156 is also shown.

[0072] When present, the proximal flexible tube 151c serves as a stress buffer between the proximal connector 151 and the Y-connector 156, the distal catheter shaft 154, and the angioplasty balloon 159. When present, the valve 156a can be used to introduce fluid into one or more liquid passages of the intravascular pulsed lithotripsy subsystem 150. In some cases, the valve 156a is absent. For example, as described herein, the intravascular pulsed lithotripsy subsystem 150 can be a closed or sealed system that provides pre-filled liquid to the user, in some cases, a liquid with a suitable contrast agent. In these cases, the valve 156a may not be provided because the use of the intravascular pulsed lithotripsy subsystem 150 will not require liquid perfusion. In other cases, the valve 156a is a three-way connector having a one-way valve protruding from one of the three-way connectors. This one-way valve 156a allows for simple perfusion of the catheter 154 and the balloon 159. In other embodiments including a three-way connector, the connection to the proximal flexible tube 151c and the Y-connector 156 uses a rotary Luer fitting to facilitate easy positioning of the catheter 154 and the valve 156a relative to other aspects of the system 100.

[0073] U.S. Patent No. 11464949, U.S. Published Patent Application Publication No. 20200046949, and pending PCT Application Serial No. PCT / US2020 / 055458 and pending PCT Application Serial No. PCT / US2022 / 014785 provide additional details regarding intravascular pulsed lithotripsy subsystems that can be incorporated into embodiments of the present invention; their disclosures are incorporated herein by reference.

[0074] As described herein, the output of the handle 111, including the oscillator 141, is operably connected to the intravascular pulsed lithotripsy subsystem 150. In particular, the output of the handle 111 is connected to the input of the proximal connector 151. The proximal connector 151 is configured to convert the potential energy (e.g., pneumatic pressure, i.e., the first pulse energy) generated by the oscillator 141 into a second potential energy (e.g., hydraulic pressure, i.e., the second pulse energy). In some embodiments, the system may include multiple connectors, each corresponding to each of the multiple handles. In an embodiment, the proximal connector 151 includes an interface for releasably and operably connecting to the interface of the handle 111, and the shape and / or connection and / or interlocking elements of the interface are the same as those of the connector 113 of the atherectomy subsystem 160, such that each of the connector 113 and the proximal connector 151 can be operably connected to the handle 111 interchangeably.

[0075] The output of the proximal connector 151 is operably connected to the catheter 154 to allow the potential energy (i.e., the second pulse energy) output from the proximal connector 151 to be input into the catheter 154 (e.g., one or more fluid channels within the catheter 154 such that the volume within the proximal connector 151 is in fluid communication with the catheter 154). In some cases, the intravascular pulsed lithotripsy subsystem 150 includes more than one catheter 154, or the catheter 154 includes more than one fluid channel inside or outside the catheter 154, such that in either case, the distal balloon 159 or different parts of the catheter 154 can be operated independently. For example, the distal balloon 159 may include multiple different balloons, each of which can be independently pressurized or inflated and deflated, e.g., different aspects of the cardiac tissue compliance element.

[0076] Referring again to Figure 1A , in the intravascular pulsed lithotripsy subsystem 150 of the system 100, the catheter 154 includes a lumen dedicated to the guidewire 157, such that the catheter 154 can be guided to the cardiovascular tissue treatment site 198 via a standard over-the-wire (OTW) guidewire method. Alternatively, in an embodiment, the catheter 154 includes one or more guidewire ports for the guidewire 157, such that the catheter 154 and the balloon 159 can be guided to the cardiovascular tissue treatment site 198 via a standard rapid exchange (RX) guidewire method. In other embodiments, the intravascular pulsed lithotripsy subsystem 150 is configured to be used with a monorail method.

[0077] The intravascular pulsed lithotripsy subsystem 150 can be configured to include a guidewire exit port 157a for the proximal region of the guidewire 157, the proximal region of the guidewire 157 passing through the lumen, guidewire channel, loop or circuit of the catheter 154. The intravascular pulsed lithotripsy subsystem 150 can include a guidewire exit port 157b opposite the guidewire entry port, which is present in the relatively distal region of the intravascular pulsed lithotripsy subsystem 150, such as at the distal end of the distal balloon 159. In an embodiment, the guidewire exit port 157b can be oriented substantially parallel to the longitudinal axis of the catheter 154 and thus also parallel to the longitudinal axis of the guidewire channel within the catheter 154 to avoid any unnecessary bending of the guidewire 157. As described herein, the system 100 can be configured relative to the guidewire 157 and the intravascular pulsed lithotripsy subsystem 150 such that the system 100 is an over-the-wire (OTW) or rapid exchange (RX) or monorail system or the like.

[0078] In some cases, the atherectomy subsystem and the intravascular pulsed lithotripsy subsystem can include the same guidewire. That is, referring to Figures 1A - 1C , the guidewire 157 and the guidewire 167 can be the same guidewire. In this case, the guidewire 167 is first inserted into the blood vessel 199 and used to guide the atherectomy subsystem 160 to the desired location such that an atherectomy procedure can be performed; subsequently, the atherectomy subsystem 160 is removed from the blood vessel 199 while the guidewire 167 remains in position within the blood vessel 199; then, the guidewire 167 is used to guide the intravascular pulsed lithotripsy subsystem 150 to the desired location such that an intravascular pulsed lithotripsy procedure can be performed. In this case, the guidewire 167 is inserted into the blood vessel 199 once and used by each of the atherectomy subsystem 160 and the intravascular pulsed lithotripsy subsystem 150. Embodiments of the present invention provide advantages over conventional methods in that at least a single guidewire (such as the guidewire 167) can be used for both the atherectomy subsystem 160 and the intravascular pulsed lithotripsy subsystem 150, thus simplifying and streamlining the process of treating the lesion 198 using each subsystem.

[0079] In such as Figure 1AIn the illustrated embodiment, the distal balloon 159 is present in the distal region of the catheter 154. In system 100, the distal balloon 159 is configured to engage a lesion 198 present within the vessel wall 199 such that applying pressure to the distal balloon 159 causes calcium deposits of the lesion 198 to break or otherwise be disrupted within the vessel 199. As described herein, the distal balloon 159 may comprise a non-compliant / compliant material. In an embodiment, a space is created within the lesion 198 where the distal balloon 159 is positioned using the atherectomy tool 169 of the atherectomy subsystem 160. For example, any suitable balloon or balloons or cardiac tissue compliant element may be used for the distal balloon 159. Suitable balloons include, but are not limited to, standard angioplasty balloons such as compliant and non-compliant angioplasty balloons. In one embodiment, the balloon is a composite balloon comprising two different layers, the layers comprising a non-compliant layer and a compliant layer.

[0080] In some embodiments, the distal balloon 159 may comprise more than one balloon, each balloon configured to be independently operable, i.e., independently pressurized and depressurized, e.g., by hydraulic pressurization transmitted via a separate fluid channel of the catheter 154.

[0081] In an embodiment, when the distal balloon 159 is repeatedly pressurized and depressurized, fluid (e.g., blood) is allowed to perfuse through the distal balloon 159 even when pulsed energy is applied to the tissue (e.g., cardiovascular tissue) at the treatment site 198 (i.e., pulsed inflation allows fluid to perfuse through the balloon during portions of the pulse cycle when the balloon is substantially deflated). This configuration enables blood to flow through the distal balloon 159, thereby allowing for an extended treatment time.

[0082] Embodiments of the pulsed intravascular lithotripsy subsystem 150 may also be configured to isolate, suspend, or otherwise filter the fluid perfusing through the distal balloon 159, e.g., to protect the surrounding vasculature from distal embolization. In some cases, the pulsed intravascular lithotripsy subsystem 150 includes a filter located distal to the distal balloon 159, which filter may be attached to the distal balloon 159 and / or the catheter 154 and / or the guidewire 157.

[0083] In an embodiment, one or more filters may be attached to the distal region or distal end of, for example, the guidewires 157, 167 or the microcatheter 154 or the lateral delivery assembly 164. Such filters may comprise any suitable filter configured to receive and collect debris or broken-off portions (e.g., emboli) of the lesion 198 (such as calcified plaque) that break off or are disrupted during operation of the atherectomy subsystem or the pulsed intravascular lithotripsy subsystem, thereby securing and preventing such debris or emboli from traveling within the vasculature. Although as described herein, Figures 1A - 1CShows a combined atherectomy subsystem and a pulsed intravascular lithotripsy subsystem with separate tools, Figures 2A - 2B Shows a combined atherectomy subsystem and a pulsed intravascular lithotripsy subsystem with integrated tools. However, as described below, one or more distal filters are not limited to one or the other of such embodiments, nor to one or the other of the atherectomy subsystem or the pulsed intravascular lithotripsy subsystem. Similarly, embodiments of the present invention can be configured such that the distal regions of the atherectomy subsystem and / or the pulsed intravascular lithotripsy subsystem are configured to aspirate fluid such that shed debris or ruptured portions (such as emboli) of a lesion (such as a calcified plaque) are aspirated, thereby removing them from the blood vessel and preventing them from traveling within the vasculature.

[0084] In some cases, aspects of system 100, such as aspects of the console assembly 110 (e.g., the controllers 130a, 130b or the power source 121), the handle 111, the oscillator 141, the pulsed intravascular lithotripsy subsystem 150 (e.g., the proximal connector 151 or the distal balloon 159), or the atherectomy subsystem 160 (e.g., the rotating assembly 161 or the connector 113 or the lateral transfer assembly 164 or the atherectomy tool 169) can be configured to be reusable. In some cases, aspects of system 100 (e.g., the catheter 154 or the distal balloon 159 or the lateral transfer assembly 164 or the atherectomy tool 169) can be configured to be single-use. That is, these elements can be disposable. The terms "reusable" and "disposable" herein and in other parts of the specification are used for convenience of description (e.g., Figures 1A - 1C shown in and shown in 2A-B) of the embodiments of the present invention described in detail below. However, the present invention is not limited thereto. Thus, any part of the system can be configured to be single-use or multi-use as needed.

[0085] Now referring to Figure 2A -B, according to another embodiment, another combined atherectomy and pulsed intravascular lithotripsy platform is described. In this case, the platform has a combined tool. In Figures 2A - 2B wherever not otherwise explicitly stated, elements having the same or similar reference numerals have the same or similar characteristics as the corresponding elements in Figures 1A - 1C The description of the elements already described above in connection with Figures 1A - 1C will not be repeated below.

[0086] System 200 includes a combined tool 297( Figure 2BIntegrated atherectomy subsystem 260 and pulsed intravascular lithotripsy subsystem 250 (in the figures). These subsystems are integrated in a region relatively distal to connection 258. Such an integrated embodiment enables a user (e.g., an operator or clinician) to insert a single catheter assembly into a blood vessel, connect the atherectomy subsystem 260 to the handle 211, perform an atherectomy procedure using the integrated atherectomy subsystem 260, disconnect the atherectomy subsystem 260 from the handle 211, connect the pulsed intravascular lithotripsy subsystem 250 to the handle 211, and perform a pulsed intravascular lithotripsy procedure. That is, using such an embodiment with integrated tools, the user can insert the catheter assemblies (i.e., the combined tool 297) of the integrated atherectomy subsystem 260 and the pulsed intravascular lithotripsy subsystem 250 into the blood vessel only once during atherectomy and pulsed intravascular lithotripsy treatments. Avoiding inserting multiple components or catheters or guidewires into the blood vessel provides the advantages of reducing the surgical time and complications.

[0087] In some cases, as described in more detail herein, the atherectomy tool 269 is combined with the guidewire 257 for pulsed intravascular lithotripsy. That is, the atherectomy tool 269 can be present on the guidewire 257 operably connected to the distal balloon 259 of the pulsed intravascular lithotripsy subsystem 250. In this case, the guidewire 257 can be referred to as an atherectomy guidewire. Similar to a conventional guidewire, the atherectomy guidewire 257 has a proximal end (i.e., relatively close to the connector 251 and the rotary assembly 261) and a distal end (i.e., relatively close to the distal balloon 259 and the atherectomy tool 269). In an embodiment, the distal end of the guidewire 257 can be coated with an abrasive material to produce the grinding head that forms the atherectomy tool 269. In other cases, the grinding head that forms the atherectomy tool 269 can be assembled onto the shaft of the guidewire 257.

[0088] Depending on the axial position of the atherectomy tool 269, the tool can be used in two ways: (1) passing through the stenosis lesion 298 within the blood vessel 299 and then abrading within the lesion, or (2) creating a new passage by pressing tightly against the stenosed or occluded blood vessel 299 and abrading or drilling. The proximal end of the guide wire 257 can be back-loaded onto the intravascular pulsed lithotripsy catheter 254 or an area thereof to provide support for the catheter 254. Subsequently, the intravascular pulsed lithotripsy catheter 254 provides support for the atherectomy tool 269 during its rotation or orbital movement and provides an accommodation area for the rotation of the guide wire 257. The lateral transfer assembly 264 includes the guide wire 257 and the catheter 254. That is, in the distal region of the connection 258, the lateral transfer assembly 264 includes the guide wire 257 present within the catheter 254, and in the proximal region of the connection 258, the lateral transfer assembly 264 includes the guide wire 257 separated from or not within the catheter 254.

[0089] In a direction relatively distal from the connection 258, the lateral transfer assembly 264 includes the guide wire 257 integrated into the catheter 254 such that the guide wire 257 can provide support for the catheter 254 and the catheter 254 can provide support for the atherectomy tool 269 and an accommodation area for the rotation or orbital movement of the lateral transfer assembly 264.

[0090] The system 200 is an example of a combined atherectomy and intravascular pulsed lithotripsy platform with a combined tool, in part because aspects of the intravascular pulsed lithotripsy subsystem 250 and the atherectomy subsystem 260 are integrated together at the connection 258 and distal to the connection 258. As described, in a direction relatively distal from the connection 258, the catheter 254, the lateral transfer assembly 264, and the guide wire 257 are integrated such that the guide wire 257 can be present within the catheter 254 or otherwise attached to the catheter 254. In some embodiments, the lateral transfer assembly 264 includes the guide wire 257, and such a guide wire is configured to rotate to transfer energy from the rotation assembly 261 to the atherectomy tool 269 within the catheter 254. That is, the rotation assembly 261 rotates the guide wire 257 within the catheter 254. In some cases, the catheter 254 and the guide wire 257 are configured to form a fluid bearing to facilitate the rotation of the guide wire 257, particularly to facilitate heat dissipation associated with the rotation of the guide wire 257.

[0091] As Figures 2A - 2B shown, similar to Figures 1A - 1C, the atherectomy lateral transfer assembly 264 is connected to a rotation assembly 261 that provides rotational movement of the atherectomy tool 269. As described herein, the rotation assembly 261 can include a motor, for example, configured to rotate the lateral transfer assembly 264. This rotational movement is used to drill through areas in the lumen 299 that are too narrow for the pulsed intravascular lithotripsy catheter 254 and the distal balloon 259 to pass through. This drilling operation is performed to dilate the lumen 299 within the lesion 298 (e.g., occlusion and / or calcification) so that pulsed intravascular lithotripsy can be performed on the calcification 298 using the distal balloon 259 of the pulsed intravascular lithotripsy subsystem 250. In embodiments of a combined atherectomy and pulsed intravascular lithotripsy platform (such as system 200) with a combined tool, after drilling or dilating a hole in the lesion 298, the combined tool including the atherectomy tool 269, the distal balloon 259, the guide wire 257, the catheter 254, and the lateral transfer assembly 264 can be advanced by moving the combined tool along the longitudinal axis 268 such that the distal balloon 259 can be positioned relative to the lesion 298 to apply pulsed energy to the lesion 298, causing the calcified plaque in the lesion 298 to rupture or otherwise fragment or be disrupted from the hole drilled or dilated by the atherectomy tool 269. In such cases, the distal balloon 259 can be positioned to apply pulsed energy to the lesion 298 from the hole drilled or dilated by the atherectomy tool 269 without removing the atherectomy subsystem 260 from the lumen 299. Instead, by, for example, moving the catheter 254 with the distal balloon 259 in a relatively distal direction within the vessel 299, the distal balloon 259 is positioned into or near the lesion 298, and the pulsed intravascular lithotripsy subsystem 250 begins to apply pulsed energy to the lesion 298.

[0092] In an embodiment, the atherectomy subsystem 260 is separated from the handle 211, and the pulsed intravascular lithotripsy subsystem 250 is attached to the handle 211 without reinserting additional or different tools into the lumen 299. That is, since the pulsed intravascular lithotripsy subsystem 250 and the atherectomy subsystem 260 are integrated together in the distal region of the connection 258, no additional tools need to be inserted into the vessel 299 when transitioning from an atherectomy procedure to a pulsed intravascular lithotripsy procedure.

[0093] Figure 2BSchematic illustration of a combined tool 297 of a system 200 according to an embodiment of the present invention, the system including aspects of an atherectomy subsystem 260 and aspects of an intravascular pulsed lithotripsy subsystem 250. The atherectomy tool 269 is present in the distal region of the guidewire 257 and is configured to receive power from the rotation assembly 261 such that the atherectomy tool 269 can drill into the lesion 298 within the blood vessel 299. In the depicted embodiment, the lateral transmission assembly includes the guidewire 257. The rotation assembly 261 is operably connected to the connector 213, which itself is operably connected to the handle 211. As described herein with respect to Figures 1A - 1C connector 113, similarly, the connector 213 can be a through device configured to transfer potential energy from the output of the handle 211 to the rotation assembly 261.

[0094] In the combined tool 297, the atherectomy tool 269 is directly connected to the distal balloon 259 and the catheter 254 of the intravascular pulsed lithotripsy subsystem 250 such that the guidewire 257 can be received within the catheter 254 in a portion of its lateral extent. The distal balloon 259 receives energy transmitted from the proximal connector 251 via the catheter 254 for performing intravascular pulsed lithotripsy. Use of the combined tool 297 may involve using the atherectomy tool 269 of the atherectomy subsystem 260 to drill or dilate an opening in the lesion 298 within the blood vessel 299. Once such a hole has been drilled or dilated, the catheter 254 of the intravascular pulsed lithotripsy subsystem 250 can be advanced distally within the blood vessel 299 to engage the distal balloon 259 with the lesion 298 via the newly drilled or dilated hole. Once the distal balloon 259 can be positioned at a desired location within such a hole in the lesion 298, intravascular pulsed lithotripsy can be initiated by transmitting pulsed energy from the proximal connector 251 to the distal balloon 259. That is, an important feature of the combined tool 297 is that the atherectomy tool 269 does not use a separate guidewire or catheter mechanism but is present on the guidewire 257, which itself is connected to the distal balloon 259 such that it is not necessary to remove the atherectomy subsystem 260 from the blood vessel 299 before initiating an intravascular pulsed lithotripsy procedure using the intravascular pulsed lithotripsy subsystem 250. In this embodiment, the guidewire 257 with the atherectomy tool 269 provides support for the catheter 254 and the balloon 259, and the catheter 254 and the balloon 259 also provide support for the guidewire 257 with the atherectomy tool 269.

[0095] In embodiments having a combined tool, such as combined tool 297, system 200 is an integrated atherectomy and intravascular pulsed lithotripsy system. In an embodiment, the atherectomy subsystem 260 and the intravascular pulsed lithotripsy subsystem 250 include the integrated tool 297. For example, the atherectomy subsystem 260 and the intravascular pulsed lithotripsy subsystem 250 may include a common distal region, such as the region distal to connection 258 in system 200. In some cases, both the atherectomy subsystem 260 and the intravascular pulsed lithotripsy subsystem 250 include a shared guidewire 257. In system 200, the lateral transfer assembly is the guidewire 257.

[0096] System 200 may be configured such that system 200 is an over-the-wire (OTW) system. For example, in some cases, the guidewire is present along most of the length of the atherectomy subsystem 260 and the intravascular pulsed lithotripsy subsystem 250. In other cases, system 200 may be configured such that system 200 is a rapid exchange (RX) system. For example, in certain cases, the guidewire 257 is present only in the distal regions of the atherectomy subsystem 260 and the intravascular pulsed lithotripsy subsystem 250. In still other cases, embodiments of the system may be configured as a monorail system. That is, embodiments of the system may use a guidewire with monorail technology.

[0097] In embodiments of a system having a combined tool with a guidewire shared between the atherectomy subsystem and the intravascular pulsed lithotripsy subsystem, the distal region of the guidewire may be coated with an abrasive material, and such an abrasive material coating may include an atherectomy tool, such as a distal burr. In some cases, the abrasive material coating has a predetermined diameter selected based on the treatment effect. In other cases, the abrasive material coating has a predetermined diameter selected based on the diameter of the distal balloon of the intravascular pulsed lithotripsy subsystem. In an embodiment, such a predetermined diameter is selected such that the distal balloon of the intravascular pulsed lithotripsy subsystem can be inserted into the hole created by the abrasive material.

[0098] In other cases of a system having a combined tool with a guidewire shared between the atherectomy subsystem and the intravascular pulsed lithotripsy subsystem, the intravascular pulsed lithotripsy subsystem includes a guidewire lumen. In such a case, the shared guidewire may be present within the guidewire lumen of the intravascular pulsed lithotripsy subsystem. In some embodiments, the system may further include a filter on the guidewire distal to the atherectomy tool, such as region 296 including the filter. In an embodiment, such a filter is configured to protect the vasculature from distal embolization, such as embolization associated with drilling the lesion and / or applying pulsed energy to the lesion.

[0099] In other embodiments of the present invention that do not include a combined tool or a combined distal region, the atherectomy subsystem and the intravascular pulsed lithotripsy subsystem have separate distal regions. In such embodiments that do not include a combined tool, the catheter component of the intravascular pulsed lithotripsy subsystem is separate from the atherectomy subsystem.

[0100] An embodiment of a method of using a system of the present invention having a combined tool (such as system 200) includes: inserting a sheath / guide catheter into blood vessel 299; inserting a guide wire 257 having an atherectomy tool 269 into blood vessel 299; loading an intravascular pulsed lithotripsy balloon 259 and a catheter 254 onto guide wire 257 such that guide wire 257 provides stability for catheter 254; loading guide wire 257 into a rotation assembly 261 (i.e., an atherectomy motor); locking guide wire 257 to rotation assembly 261; connecting a connector 213 to a handle 211; advancing atherectomy tool 269 by holding a handle button or the like and advancing guide wire 257 to run a treatment including an atherectomy procedure; generating sufficient lumen gain to allow intravascular pulsed lithotripsy balloon 259 to enter a lesion 298; further advancing guide wire 257 in a distal direction into lesion 298 such that atherectomy tool 269 advances beyond the treatment site; that is, into the position where the atherectomy tool was previously used to dilate the lesion; advancing intravascular pulsed lithotripsy balloon 259 through the treatment site; disconnecting atherectomy connector 213 from handle 211 and connecting an intravascular pulsed lithotripsy proximal connector 251 to handle 211; and treating using intravascular pulsed lithotripsy subsystem 250, i.e., transmitting pulsed energy to lesion 298 via distal balloon 259. Atherectomy connector 213 can be disconnected from handle 211, and proximal connector 251 can be connected to handle 211 because each such element includes an interface having, for example, a shape or interlock or connector or other alignment features that enable each of connector 213 and proximal connector 251 to be interchangeably and operably connected to handle 211.

[0101] Console:

[0102] The console device of the embodiments of the present invention can vary. In some examples, the console device is a compact, self - contained unit that is designed for ease of use and versatility. The device can include a housing for protecting internal components and providing a safe and stable base for operation. The housing can be designed to be rugged and resistant to damage caused by operation and environmental factors such as dust and moisture. The console device can be configured to be attached to an intravenous infusion pole, for example, using clamps, such as using two clamps to firmly secure the device in place. In these embodiments, the clamps can be adjusted to accommodate various sizes of intravenous infusion poles, ensuring compatibility with various equipment. Additionally, the console device can include a table stand that provides stability when the device is used on a flat surface.

[0103] In some cases, the console device includes a gas inlet port that allows connection to high - pressure gases such as compressed gas, carbon dioxide, nitrogen, etc. The gas inlet port can be designed to ensure a safe and leak - free connection to the gas source. The console device can include a pressure - reducing regulator that regulates the input high - pressure gas to the required output pressure. The regulator can be designed to provide precise and consistent pressure regulation, ensuring the safe and effective delivery of the regulated gas. The console device of the embodiments of the present invention can include a proportional valve or an electronic control valve for outputting the required pressure or flow rate. The valve can be designed to provide precise control of the output pressure or flow rate, ensuring the safe and effective delivery of the regulated gas.

[0104] Since the console device operates using electricity, power can be provided through a power inlet cable connector. The cable connector can be designed to be safe and resistant to damage caused by operation and environmental factors. The console device can include a wire harness that provides connections to internal components to ensure safe and reliable electrical connections. If needed, the console device can include a voltage converter that converts the input power to the voltage required by the internal components. The voltage converter can be designed to be efficient and reliable, ensuring the continuous operation of the console device.

[0105] In an embodiment, the console device can include fluid management components for handling the output of fluid (such as pressurized sterile normal saline). It can include a sterile normal saline reservoir, a pump for pressurizing the normal saline, and a pipeline for guiding the normal saline to the treatment area. The fluid management components can be designed to ensure the sterile and safe delivery of the pressurized normal saline, ensuring the overall safety and effectiveness of the treatment process. The fluid management system can also be designed to be easy to use and maintain, ensuring the effective operation and maintenance of the console device.

[0106] The console device can use various sensors to monitor the performance of the console device and ensure the safe delivery of potential energy, such as high-pressure gas. For example, pressure sensors can be used to measure the pressure within the system and can be used to measure the remaining amount of gas. Optical or other types of flow sensors can be used to detect changes in gas flow, and temperature sensors can be used to monitor the temperature of components to prevent overheating or overcooling environments. Humidity sensors, such as humidity sensors inside and / or outside the console, can be used to ensure that the humidity level remains within an acceptable range, detect leaks, and / or detect the accumulation of condensation due to exhaust gases. Additionally, connection sensors can be used to detect when the connection cables (as described herein) are correctly connected to the console and when they are disconnected. In an embodiment, this information can be crucial for ensuring that the console operates as expected and for stopping the gas flow if a disconnection is detected. By using a combination of these sensors, in an embodiment, the console is able to monitor its own performance and make adjustments to ensure the safe and efficient delivery of potential energy, such as high-pressure gas. The sensors can be configured to provide valuable feedback to the system, enabling the system to operate more efficiently and effectively while also protecting the user and patient from potential risks.

[0107] The console device can include a display screen that provides real-time information to the user, such as pressure and flow readings, the duration of the treatment, and other relevant information. The display screen can be easy to read and provide clear and concise information to the user. In an embodiment, the console device is equipped with a display screen that presents information to the user, including, for example, the current treatment type, intensity, and duration. The console device can also be equipped with software that runs programs to determine the treatment type, intensity, and treatment duration and can be preset and user-adjusted based on sensor input or based on artificial intelligence, machine learning, etc.

[0108] The console device can also be equipped with an adjustment component that can change the settings of the device based on user feedback or other sensor input. This component can be configured to allow the console device to continuously monitor and adjust its performance to ensure that the regulated gas output remains within safe and effective parameter ranges.

[0109] The software of the console device can be designed to receive various sensor inputs and adjust the treatment settings in real time. The software can be configured to continuously monitor inputs from various sensors, such as sensors that measure gas pressure, flow, imaging, vascular pressure and / or blood flow, as well as patient vital signs. The software then uses this input to adjust the treatment settings, such as the intensity and duration of the regulated gas output. The software can be programmed with various presets for different types of treatments, and these presets can be modified by the user or based on artificial intelligence algorithms. Such artificial intelligence algorithms are capable of analyzing the sensor input to determine whether the treatment settings need to be adjusted to ensure that the regulated gas output remains within safe and effective parameter ranges. In addition, the software can integrate user feedback, such as manual adjustments made by caregivers or patients, to further optimize the treatment settings. The software will integrate this feedback and adjust the treatment settings accordingly to provide the most effective and efficient treatment.

[0110] The console device can be configured to self-adjust based on feedback or feedforward models, providing a highly adaptable and responsive system for delivering potential energy, such as delivering regulated gas. A feedback model refers to adjustments made by the console device based on actual sensor inputs and performance results. For example, the console device can monitor gas pressure and adjust the regulating component to keep the pressure within a safe and effective range. The software can also analyze the sensor input and make real-time adjustments to the treatment settings, such as the intensity and duration of the regulated gas output. A feedforward model refers to adjustments made by the console device based on predicted future inputs or performance results. For example, the software can be programmed with artificial intelligence algorithms that are capable of analyzing sensor data and predicting potential future changes in the patient's condition. Based on these predictions, the console device can pre-adjust the treatment settings to ensure that the regulated gas output remains within safe and effective parameter ranges.

[0111] In an embodiment, the console device can communicate with a cloud-based server or cloud-based data, or otherwise previously stored data, to improve or recommend treatment regimens. Such communication allows the device to access a wealth of information and knowledge, providing a more personalized and effective treatment experience for the patient. In an embodiment, the console device is capable of communicating with a cloud-based database or an electronic medical record system to access the patient's previous treatment history and other relevant information, such as their medical history, current medications, and vital signs. This information can then be used to tailor the treatment settings for each patient, providing a more personalized and effective treatment experience. The console device can be configured to access previously stored data to improve its performance over time. For example, the device can analyze past treatment data to identify trends and patterns, and this information can be used to improve the accuracy and efficiency of future treatments.

[0112] In some cases, the console device can be configured to communicate with other devices (such as remote monitoring devices) to access additional information that can be used to improve the treatment protocol. For example, the console device can be configured to receive data from a wearable device that measures a patient's vital signs, and this information can be used to adjust the treatment settings to ensure that the output of the regulated gas remains within safe and effective parameter ranges. In an embodiment, the console device can communicate with various external devices to be programmed by these devices, receive information from these devices, or provide information to these devices. This communication is supported by various wired and wireless communication protocols, including RS232, USB, Ethernet, Wi-Fi, and Bluetooth. Additionally, depending on the specific needs and requirements of the device, the console device can support other communication platforms such as Zigbee, NFC (Near Field Communication), MQTT (Message Queuing Telemetry Transport), MODBUS, and CAN (Controller Area Network). These communication protocols allow the console device to have a high degree of flexibility and adaptability, ensuring compatibility and communication with various external devices.

[0113] The console device can include connectors, such as a pair of mating connectors, that allow for a secure and reliable connection between the console device and the connecting cable. In this case, one connector can be fixed to the outside of the console, while the other connector is connected to the connecting cable. These connectors can be paired with two gas ports (an inlet and an outlet) and an electrical connector that provides power and communication.

[0114] Figure 3A-Figure B provides an illustration of console devices 300a, 300b according to embodiments of the present invention. The console devices 300a, 300b are configured to provide potential energy in the form of high-pressure gas (e.g., high-pressure gas from tank 321b). Connectors 310a, 310b are configured to connect the console devices 300a, 300b to a high-pressure gas source 321b. The input / output connector and control device 320a can be used to forward the regulated high-pressure gas to other aspects of the system (e.g., the atherectomy subsystem and the pulsed intravascular lithotripsy subsystem, in each case via a handle), and can include console input / output ports, which in some cases can include HDMI ports or USB ports for transmitting data to or from the consoles 300a, 300b. The display screen 330a can be used to provide real-time information to a user or operator (such as a clinician), such as pressure and flow readings, treatment duration, and other relevant information. Console 300a includes a console input 340a for inputting information into a controller within console 300a to adjust the behavior of the system. Input 340a includes buttons or controls for selecting treatment intensity and mode, as well as an emergency shutdown button for enabling and disabling console components 300a. Consoles 300a, 300b also include console enclosures 390a, 390b, which are configured to form a housing, e.g., a housing configured to protect console components during an accidental drop or packaging. Console enclosures 390a, 390b (if any) can be made of a suitable rigid material (e.g., polymeric material) and can be transparent or opaque as needed. Console 300b also includes a mechanical regulator 322b1 and an electronic regulator 322b2 for adjusting the potential energy received from the pressure source 321b via the inlet 310b before outputting the potential energy at the handle connection 320b.

[0115] As described above, the system of the present invention includes a console. The console, also referred to as a console unit or a console subsystem or a console component, in embodiments of the system according to the present invention, is used to generate the power and control required to use the system to treat biological tissue (such as cardiovascular tissue).

[0116] An embodiment of a console according to the present invention includes a potential energy source, or is operably connected to a potential energy source. The potential energy source of an embodiment of the present invention is configured to provide energy, which can be regulated by a regulator as needed. Any suitable potential energy source can be employed, examples of potential energy sources including a voltage source, a pressure source, an electromagnetic source, an electric field source, a chemical source, etc. In some embodiments, the potential energy source is a pressure source, examples of suitable pressure sources including, but not limited to: a compressed cylinder, a compressor, etc. If needed, the potential energy source can be operably coupled to a regulator that is configured to regulate the energy from the potential energy source into a suitable form such that, for example, an oscillator or a manifold assembly can further act thereon. For example, when the potential energy source is a high-pressure gas source, the regulator can be used to regulate the pressure of the gas to a suitable value that can be input into the oscillator. In addition to a positive potential energy source (such as high-pressure gas), potential energy sources of interest can also include a negative potential compared to a reference potential or a standard potential, for example, a potential energy source configured to provide a vacuum potential compared to standard atmospheric conditions.

[0117] In some embodiments, the console includes more than one potential energy source. In embodiments including more than one potential energy source, the potential energy provided by each potential energy source can be of the same type, or can be a combination of different potential types. For example, each potential energy source can be a pressure source (at the same or different potential levels), or alternatively, one potential energy source can be a pressure source while the other potential energy source can be a voltage source.

[0118] In an embodiment, the console component may further include one or more regulators (i.e., power regulators), output ports, and a controller. Regarding the power regulator, as described above, in an embodiment, the potential of the potential energy source may be regulated from a first input potential to a second potential, e.g., a potential suitable for transmission to another aspect of the oscillator or manifold assembly or the atherectomy subsystem or the pulsed intravascular lithotripsy subsystem, and ultimately for treating biological tissue, such as cardiovascular tissue. The potential of the potential energy source may be regulated to a predetermined value, a user-set value, or may be regulated according to various feedback inputs that occur during treatment. In some cases, the potential of the potential energy source may be dynamically regulated at least in part based on conditions related to a treatment involving delivering pulsed energy to biological tissue, such as cardiovascular tissue, e.g., based on changes in tissue compliance during treatment. In some cases, the potential of the potential energy source may be regulated in real time or substantially in real time. In certain embodiments, the potential of the potential energy source may be adjusted to an optimal value for a particular treatment. For example, the potential of the potential energy source may be adjusted to an optimal value for treating diseased heart tissue (e.g., heart tissue having calcification or occlusion), or, e.g., the potential of the potential energy source may be adjusted to an optimal value for treating diseased heart tissue using the atherectomy subsystem or the pulsed intravascular lithotripsy subsystem. In some examples, one or more inputs from the console, the handle, the atherectomy subsystem, the pulsed intravascular lithotripsy subsystem, the user, or the oscillator, or one or more inputs from a source external to the system (e.g., other measurements of the subject, such as imaging of the subject) may be used to determine optimal treatment conditions, e.g., the output potential of the potential energy source suitable for a desired treatment (e.g., treatment using the atherectomy subsystem or treatment using the pulsed intravascular lithotripsy subsystem of a combined system), and then be used to adjust to accommodate that condition.

[0119] In embodiments including a regulator (i.e., a power regulator or potential regulator) configured to regulate the potential of a potential energy source, such a regulator may be a passive regulator (i.e., a preset or user-adjusted regulator) or an active regulator (i.e., a regulator controlled, e.g., with an electrical pulse or other dynamic signal from, e.g., a controller). Regulators of interest may include regulators commonly used for fluid regulation (such as directional valves or diaphragm valves), regulators for electrical regulation (such as voltage regulators), regulators for optical power regulation, etc. In embodiments including more than one potential energy source, the potentials of the various potential energy sources may be regulated together or separately.

[0120] In an embodiment, the regulated and / or unregulated potential (i.e., potential energy) from the potential energy source is output through an output port operably coupled to the handle for transmission to the atherectomy subsystem and / or the intravascular pulsed lithotripsy subsystem. In an embodiment, any suitable output port may be employed, such as commercially available connectors, such as pneumatic connectors, hydraulic connectors, electrical connectors, or optical connectors. In some cases, the energy may be converted to another form of energy before the unregulated or regulated potential energy is output from the console, or in some cases, after the unregulated or regulated potential energy is output from the console (i.e., transferred or otherwise transmitted to other aspects of the system).

[0121] In some cases, the console may include more than one unit that is physically separate or connected, i.e., each console unit capable of being operably interconnected (e.g., electrically interconnected, fluidly interconnected, using radio frequency (RF) interconnection, etc.). That is, the console may include an integral component or two or more different, operably connected units.

[0122] In some cases, at least some of the console components are present in a unit configured to be held or manipulated by hand (e.g., moved). While the dimensional specifications of such a unit may vary as needed, in some instances, such a unit may be configured as a substantially rectangular box having a height of 10 cm to 100 cm (e.g., 20 cm to 30 cm), a width of 5 cm to 100 cm (e.g., 10 cm to 20 cm), a depth of 10 cm to 100 cm (e.g., 20 cm to 30 cm), and a mass of 1 kg to 20 kg (e.g., 5 kg to 8 kg).

[0123] In an embodiment, the console may include a first console component that houses the potential energy source and regulators and actuators for the pressure source, such as manipulable buttons. The console may include electrical connectors for providing electrical connections to various other components of the system as needed. For example, the electrical connectors may be used to receive data regarding the position and / or configuration of the distal balloon or atherectomy tool (e.g., relative to the tissue being treated (such as cardiovascular tissue) or lesion (such as a chronic total occlusion)), or data regarding pressure or volume measurements, and to provide power to sensors configured to collect such data regarding the treatment using the system.

[0124] In some cases, at least some of the console components are present in an installable unit that is configured to be positioned or secured near or at the proximal end of an operating table of a subject (i.e., a patient) such that an operator (e.g., a doctor) does not need to physically interact with the console assembly to treat the subject (e.g., the operator does not need to physically be present in an operating room or surgical suite and is able to communicate with the system at a distance via remote control). In such cases, the installable unit is designed to be easily clamped, secured, or independently stabilized on or near the operating table and is operable by a remote control unit. In such cases, the installable unit may include a communicator that provides communication between the console assembly and the remote control unit, which communicator may be implemented by any desired hardware and / or software configuration and may be configured to communicate using a wired or wireless protocol.

[0125] As needed, the console and / or its power source employed in the system of the present invention may be configured to be reusable or single-use. The console assembly employed in the system of the present invention may be configured to receive a sterile cover such that the console assembly can be used without contaminating the sterile area of an operating room. Other details regarding console units, power sources, regulators, etc. that may be employed in embodiments of the present invention are provided in U.S. Patent No. 11,464,949, U.S. Published Patent Application Publication No. 2020 / 0046949, and pending PCT Application Serial No. PCT / US2020 / 055458, and U.S. Application No. 63 / 274,832; the disclosures of which are incorporated herein by reference.

[0126] Controller:

[0127] Embodiments of the console of the system according to the present invention include one or more controllers, also referred to as controllers or control components or control subsystems. Embodiments of the system may utilize a first logic controller operably connected to an atherectomy subsystem and a second logic controller operably connected to a pulsed intravascular lithotripsy subsystem. In an embodiment, such first and second controllers may be referred to as controllers. In an embodiment, among other things, such first and second controllers control the amount and duration of energy transmitted by each of the atherectomy subsystem and the pulsed intravascular lithotripsy subsystem to tissue (e.g., cardiovascular tissue).

[0128] In some cases, embodiments of the system can utilize a controller to measure the impact of treatment on cardiovascular tissue, such as the degree to which an atherectomy tool penetrates a lesion including calcified tissue or the degree of disruption of a lesion including calcified tissue. For example, the controller can be configured to measure the degree of change in cardiovascular tissue compliance caused by treatment. In other cases, embodiments of the system can utilize a controller to control the distal and proximal movement of an atherectomy tool when pecking into an occlusion.

[0129] In an embodiment, the controller can be connected to one or more aspects of the system (including its console, such as its pressure source or its regulator, handle, oscillator, atherectomy subsystem or intravascular pulsed lithotripsy subsystem), receive information from it, and / or adjust or control it. The controller can also be configured to receive information from external systems (such as an electrocardiogram (ECG), intravascular or external pressure monitors, blood volume sensors, patient vital sign sensors or imaging systems, such as imaging systems using fluoroscopy, intravascular ultrasound (IVUS) or optical coherence tomography (OCT)), and / or control them. In addition, the controller can include multiple control units, such as the first and second controllers described above, which are interconnected such that one or more of these units are synchronized and communicate with each other.

[0130] In some cases, the controller or the control units that together constitute the controller can be configured to communicate with the components of the system such that in each case, the energy transmitted via the atherectomy subsystem (including via the atherectomy tool) or via the intravascular pulsed lithotripsy subsystem (including via the distal balloon) is appropriate, i.e., suitable for a particular treatment involving the use of an atherectomy tool and / or the application of pulsed energy to tissue. In other embodiments, the controller can receive information about the treatment state of cardiovascular tissue (such as an atherectomy treatment) from sensors, such as data signals, where the sensors provide information about location, such as the position of the atherectomy tool relative to the occlusion, the degree of drilling through the occlusion, the degree of dilation of a lesion or a hole in the occlusion, etc.

[0131] In an embodiment, the controller can be configured to provide feedback to the operator of the system of the present invention in any suitable manner. In certain cases, the controller is configured to provide tactile feedback to the operator, such as by vibration. For example, the controller can be configured to cause the handle or another interface to vibrate once a relevant change or determination occurs (such as a measurement by a sensor), e.g., once a hole is punched through the occlusion or once a relevant change in the compliance of cardiovascular tissue occurs. This tactile feedback can be used to indicate to the operator of the system embodiment to change the configuration of the system.

[0132] Manifold Assembly, Oscillator or Switch:

[0133] Embodiments of the system of the present invention include a manifold assembly. The manifold assembly (also referred to as a manifold unit or a manifold subsystem) can be used in embodiments of the system of the present invention to receive energy transmitted from a potential energy source of the console and transmit the energy to the atherectomy subsystem and to the intravascular pulsed lithotripsy subsystem. In an embodiment, the manifold assembly includes an oscillator configured to generate pulsed energy from the energy transmitted by the potential energy source. In this case, the oscillator is used to regulate the amplitude and / or time and / or frequency of the potential energy from the potential energy source to provide the desired energy for applying pulsed energy to biological tissue (such as cardiovascular tissue) via the atherectomy tool and / or the distal balloon. The pulsed energy can be utilized by the atherectomy subsystem to, for example, rotate or orbit the atherectomy tool, or in some cases, to move the atherectomy tool in the distal and proximal directions such that the atherectomy tool pecks into and out of a lesion (such as a chronic total occlusion). In an embodiment, the manifold assembly can be disposed within a handle, where the handle includes the oscillator as described herein and is configured to be manually manipulated by an operator.

[0134] In an embodiment, the manifold subsystem includes an input connection operably connected to the console output, one or more oscillators, and an output connection for ultimately transmitting energy to the atherectomy subsystem and / or the intravascular pulsed lithotripsy subsystem. Embodiments of the handle can be configured to be used in conjunction with each of the atherectomy subsystem and / or the intravascular pulsed lithotripsy subsystem, or a separate output can be configured for each such subsystem. In some embodiments where the console includes one or more console sub-units, as described herein, the manifold input connection includes one or more input connections to one of the console sub-units of the console. As described above, in an embodiment, the manifold subsystem is configured to receive energy transmitted from the console and ultimately output the energy to the atherectomy subsystem and the intravascular pulsed lithotripsy subsystem. The manifold subsystem can be configured to receive various forms of potential energy (e.g., voltage potential, electromagnetic potential, pressure potential, etc.) from one or more consoles and is configured to distribute the energy to one or more oscillators within the manifold assembly. In an embodiment, any suitable input and output connections can be employed, such as commercially available connectors, such as pneumatic connectors, hydraulic connectors, electrical connectors, or optical connectors.

[0135] In some cases, the manifold assembly or handle can receive potential energy, such as from one or more console sub-units of a console, and distribute the potential energy to one or more oscillators in the manifold assembly or handle. In some cases, there is a one-to-one correspondence between the console sub-units and the oscillators in the manifold subsystem or handle. In other cases, a single console sub-unit can deliver energy to one or more oscillators. In still other cases, one or more console sub-units can deliver energy to a single oscillator; that is, the potential energy of one or more console sub-units is combined in a single oscillator.

[0136] In an embodiment, the energy transmitted to the oscillator includes regulated or unregulated fluid under pressure. The oscillator can be actuated to output a pulse and / or a static pressure output. In some embodiments where the potential energy transmitted by the console is regulated or unregulated fluid under pressure, the oscillator can include a solenoid valve. Such solenoid valves can include, for example, two-way, three-way, normally closed solenoid valves. In such a case, the solenoid valve is configured to receive high-pressure regulated or unregulated fluid. Such solenoid valves can be configured to have two modes, namely an "open" mode and a "closed" mode. Such solenoid valves can be configured to have three ports: a port operatively connected to the high-pressure regulated or unregulated fluid (i.e., the input port), a port operatively ultimately connected to a catheter assembly (i.e., the first output port), and a discharge port (i.e., the second output port). The solenoid valve can be configured such that when open (i.e., in the "open" mode), the valve allows the high-pressure regulated or unregulated fluid to be transmitted, i.e., downstream in the system, such as to an atherectomy subsystem and / or a pulsed intravascular lithotripsy subsystem. The valve can also be configured such that when closed (i.e., in the "closed" mode), the solenoid changes (i.e., reverses) the connected ports such that the distal side of the valve is emptied (e.g., emptied to the atmosphere or a vacuum). That is, in the "closed" mode, the first output port can be connected to the second output port, thereby emptying the high-pressure fluid present on the distal side of the solenoid valve.

[0137] In some embodiments, the frequency and / or duty cycle of the oscillator can be adjusted to produce an appropriate output for therapy and for the atherectomy subsystem, including its atherectomy tool, or for the intravascular lithotripsy subsystem, including its distal balloon. In various embodiments, one or more oscillators can be configured to oscillate at one or more frequencies and / or duty cycles. In certain instances, the oscillator is configured to oscillate at a frequency from 0 to 50 Hz, such as 1 - 10 Hz or 10 - 20 Hz or 21 - 30 Hz or 31 - 40 Hz or 41 - 50 Hz, and at a duty cycle from 10% to 90%, such as 10% or 20% or 30% or 40% or 50% or 60% or 70% or 80% or 90%. In other cases, such as where the oscillator is configured to use fluid pressure to deliver pulsed pressure pulses for a therapy involving the application of the atherectomy subsystem to cardiovascular tissue, the oscillator can be configured or controlled to oscillate at a frequency from 0.25 Hz to 5 Hz, such as 1 Hz or 2 Hz or 3 Hz or 4 Hz or 5 Hz, and at a duty cycle between 10% and 90%, such as 10% or 20% or 30% or 40% or 50% or 60% or 70% or 80% or 90%. In cases where the oscillator is configured to deliver pulsed energy including an optical or high voltage source, the oscillator can oscillate at a frequency from 0.1 Hz to 1 GHz, such as 1 Hz or 2 Hz or 3 Hz or 4 Hz or 5 Hz or higher, and at a duty cycle from 0.0001% to 90%, such as 0.001% or 0.01% or 0.1% or 1% or 10% or 20% or 30% or 40% or 50% or 60% or 70% or 80% or 90%.

[0138] Additional details regarding aspects of the manifold assemblies, handles, oscillators, and their components that can be employed in embodiments of the present invention are provided in U.S. Patent No. 11464949, U.S. Published Patent Application Publication No. 20200046949, and pending PCT Application Serial No. PCT / US2020 / 055458, U.S. Application No. 63274832, and U.S. Application No. 63545060; the disclosures of which are incorporated herein by reference.

[0139] In some embodiments, the output from an oscillator, or in embodiments having more than one oscillator, the output from each oscillator, can be transmitted to one or more locations. In other embodiments that include more than one oscillator, the oscillators may be able to synchronize with each other, such that, for example, the pulse energy transmitted from each oscillator is synchronized as needed, such as in terms of amplitude, frequency, phase, duty cycle, etc. In other embodiments having one or more oscillators, the oscillators can be synchronized with external factors or systems or sensors, such as, for example, synchronized with the results of an electrocardiogram (ECG), or can be adjusted based on feedback from a controller or other subsystem (e.g., such as volume or pressure measurements originating from an atherectomy subsystem or a pulsed intravascular lithotripsy subsystem). In other embodiments, one or more oscillators can be controlled based on data related to the position of the atherectomy tool (i.e., relative to the occlusion), such as data related to whether the atherectomy tool has penetrated the lesion (such as a chronic total occlusion). That is, the controller can be configured to adjust the behavior of the oscillator at least in part based on such data.

[0140] In an embodiment, the manifold assembly or the handle may further include a plurality of inlet sources (e.g., connections to the console), a housing (e.g., the manifold for the manifold assembly or the handle housing for the handle), a plurality of oscillators, oscillator connection points (e.g., for transmitting energy from the oscillators to the catheter assembly), controller connection points (e.g., for transmitting inputs from sensors internal and / or external to the system), and a user feedback and / or control area (e.g., for the user to adjust the operation of the system). In an embodiment, the manifold assembly can be disposed entirely or partially within the handle of the system, as described herein. In other embodiments, the manifold assembly can be disposed entirely or partially within the console of the system, as described herein.

[0141] In various embodiments, the manifold assembly or the handle, similar to other aspects of the system of the present invention, can be configured to be disposable or reusable. In the case where the manifold assembly or the handle assembly is reusable and can come into contact with the patient area, such assemblies can be configured to be covered in a disposable sterile sheath or sterile bag. In some embodiments, the manifold assembly can be configured as part of the console (i.e., such that the components of the console and the manifold assembly are located within a single common housing). In other embodiments, the manifold assembly can be configured in the form of a handle, i.e., in the form of the handle of an embodiment of the present system, such that an operator of the system can hold the manifold assembly during use or therapy.

[0142] In some embodiments, as described above, components of the control subsystem or controller may be located within the manifold assembly housing and / or within the console housing and / or within the handle. In certain cases, the manifold assembly and / or the console and / or the handle include a user interface that is configured to enable an operator of the system to access the manifold assembly or the console to start or stop treatment, adjust treatment intensity, adjust treatment mode, or adjust other relevant aspects or configurations of the system.

[0143] Handle and Connecting Cable

[0144] Embodiments of the system of the present invention further include a handle that may be configured to be operably connected to the console (e.g., as described above) via a connecting cable. As described herein, in some embodiments, the handle or handle assembly includes the manifold assembly and / or the oscillator as described above. In some cases, the handle (e.g., its connecting cable) includes a connector, such as for connecting to a console device. The connector may be designed to be easily connectable and disconnectable, ensuring a secure and reliable connection between the console and the handle. The connector may also be designed to provide feedback to the user indicating a correct connection. Such feedback may include an audible or visual signal (e.g., a click or an indicator light), or a tactile signal (e.g., a vibration), indicating that the connector has been properly engaged and the system is ready for use. In embodiments, any suitable connector may be employed, such as commercially available connectors, such as pneumatic, hydraulic, electrical, or optical connectors. In other embodiments, as described herein, the handle may be operably connected to the manifold assembly or certain aspects of the manifold assembly, or may include the manifold assembly or certain aspects of the manifold assembly.

[0145] In embodiments where the console includes a pneumatic system, the pneumatic system of the console may be designed to maintain pressure without leakage, ensuring safe and effective delivery of the regulated gas. This may be achieved by using O-ring seals, compression fits, or other pneumatic sealing methods. The pneumatic system may be designed to be reliable and efficient, ensuring a stable and uninterrupted delivery of the regulated gas.

[0146] The electrical connector of the console may be designed to provide power and communication between the console and the handle, e.g., via its connecting cable (i.e., such that the handle may be powered by the console and communicate with the console via such electrical connector). This may be achieved by using a wired connection (such as a USB or RS232 cable) or a wireless connection (such as Wi-Fi or Bluetooth). The electrical connector may be designed to provide reliable and efficient power and communication, ensuring that the console and the handle can communicate effectively (e.g., via its connecting cable), and enabling the console and / or the handle and / or the manifold assembly (if present) to receive power as needed.

[0147] The console device and / or the handle can be designed to detect when one or more connectors are disconnected from each other or otherwise form an open circuit. This can be achieved by using a physical interlock mechanism, a pressure sensor, or other techniques. If a connector is disconnected, the console and / or the handle can be configured such that the console immediately stops delivering energy, such as regulated gas, and provides a visual or audible alarm to the user (i.e., the operator), indicating that the connection has been lost. In such a case, the console and / or the handle can also be configured to record the disconnection event and provide information to the user or an external device via an electrical connector.

[0148] In an embodiment, aspects of the handle (such as its connecting cable) are configured to connect the console device to the handle. The connecting cable can be designed to be flexible, durable, and reliable, such that the handle is easy to operate while maintaining a secure connection between the console and the handle and between the handle and components operably connected to the handle. Although the connecting cable may vary, in some cases, the length of the connecting cable is from 10 inches to 20 feet, allowing for a wide range of movement and positioning of the handle. In an embodiment, the connecting cable is typically from 10 inches to 20 feet long, providing a wide range of movement and positioning for the handle and thus a wide range of movement and orientation for the atherectomy subsystem and the pulsed intravascular lithotripsy subsystem.

[0149] In an embodiment, the connecting cable includes two pneumatic lines (including a high-pressure inlet hose and an exhaust hose), as well as a flexure retention wire and a cable. The pneumatic hoses can be configured to carry or transmit regulated gas from the console to the handle, while the flexure retention wire can be configured to provide stability and support for the connecting cable. The cable provides power and communication between the console and the handle, i.e., communication of data and / or control signals.

[0150] Methods for ensuring a secure and reliable connection between various components can be used to assemble the connecting cable. This can include using crimping, welding, or other methods to secure the pneumatic hoses and the cable in place. The connecting cable can also be covered with a protective layer, such as a polyurethane or silicone rubber coating, to prevent wear and tear and ensure that the flexibility and durability of the connecting cable are maintained.

[0151] In an embodiment, the handle can be configured to receive connection cable components, including a high-pressure inlet hose, an exhaust hose, a bending fixation wire, and a cable. The handle can have a variety of important functions, including controlling the airflow output and providing a physical connection point between the console and the medical device (i.e., the atherectomy subsystem, such as an atherectomy tool, and / or the intravascular pulsed lithotripsy subsystem, such as an intravascular pulsed lithotripsy catheter and / or a distal balloon). The handle can be designed to have a front side (i.e., distal) connector that is configured to physically receive a medical device connector (i.e., a connector that connects the handle to the atherectomy subsystem and / or the intravascular pulsed lithotripsy subsystem), allowing the system to regulate the gas, electricity, and communication delivered to the medical device (i.e., the atherectomy subsystem and / or the intravascular pulsed lithotripsy subsystem).

[0152] When needed, embodiments of the handle can include one or more user interface features, such as buttons for user feedback, which allow the user (i.e., the operator) to provide feedback on the system status. For example, this can be used to start or end a procedure, or to adjust the intensity or duration of the treatment, or to adjust the type of treatment applied, i.e., the treatment performed through the atherectomy subsystem or the intravascular pulsed lithotripsy subsystem. Additionally, the handle can include LEDs (e.g., to provide feedback to the user), allowing the operator to quickly and easily determine the status of the system.

[0153] The handle can include a pneumatic outlet that provides regulated gas to the medical device (i.e., the atherectomy subsystem and / or the intravascular pulsed lithotripsy subsystem). It can also have an electrical connection that is connected to the medical device connector, allowing communication between the console and the medical device. The rear end (i.e., the proximal end) of the handle can be designed with a stress relief device to ensure that the connection remains secure even during movement or handling or otherwise manipulating the handle during treatment.

[0154] In addition to physical components, the handle can also include electronic components (i.e., an electronic board, such as a printed circuit board) to control the program and receive feedback. The electronic component can run software programs that determine the type, intensity, and duration of the treatment, and can be preset and user-adjusted based on sensor input or based on artificial intelligence. The handle can be configured in a handheld or desktop configuration, and the length of the connection cable (e.g., as described above) can vary between 10 inches and 20 feet in some embodiments, depending on the specific needs of the medical institution.

[0155] In an embodiment, the handle is operably connected to the atherectomy subsystem and the intravascular pulsed lithotripsy subsystem. In some cases, the handle includes a single unit configured to house a switch (i.e., an oscillator) or other aspects of the manifold assembly described above, and the handle is configured to transmit energy to the intravascular pulsed lithotripsy subsystem and the atherectomy subsystem. In an embodiment, the handle is configured to be easily connected and disconnected from each of the intravascular pulsed lithotripsy subsystem and the atherectomy subsystem. That is, in an embodiment, a user of the system can first connect the atherectomy subsystem to the handle, perform an atherectomy procedure, subsequently disconnect the atherectomy subsystem, and connect the intravascular pulsed lithotripsy subsystem and perform intravascular pulsed lithotripsy; that is, such that a single handle (and console and power source) can be used with each of the atherectomy subsystem and the intravascular pulsed lithotripsy subsystem.

[0156] In an embodiment, the handle is configured to be held by an operator, such as during use. The handle of interest includes any suitable shape (e.g., generally cylindrical or generally rectangular), for example, the height can be from 10 cm to 100 cm, such as from 20 cm to 30 cm, the width can be from 5 cm to 100 cm (e.g., from 10 cm to 20 cm), the depth is from 10 cm to 100 cm (e.g., from 20 cm to 30 cm), and the mass can be from 1 kg to 20 kg (e.g., from 5 kg to 8 kg). In an embodiment, the handle includes one or more tactile features, that is, facilitating the gripping of the handle by a hand (e.g., a gloved hand). Such tactile features can include grooves or indentations.

[0157] Figure 4AA schematic view of a handle 400 with a connection cable 450 in accordance with aspects of the present invention is shown. The handle connection cable assembly 450 includes a handheld body 410 and a connection cable 450. The handheld body 410 is located in the relatively distal region of the handle 400. The handle 400 includes buttons 420 for receiving user feedback. The buttons 420 also include LEDs for providing feedback to the user (i.e., the operator). The output connector 430 of the handheld body 410 of the handle 400 is located at the end of the relatively distal end of the handle 400 and is configured to interface with each of the atherectomy subsystem and the pulsed intravascular lithotripsy subsystem; that is, when each of the atherectomy subsystem and the pulsed intravascular lithotripsy subsystem is connected to the handle 400, regulated pressurized fluid (such as gas) is transmitted through the output connector 430 of the handle 400 to provide energy to each of such systems. An input connector 460 is present at the relatively proximal end of the connection cable 450 of the handle 400 and is configured to connect to a console. That is, the input connector 460 is configured to receive pressurized fluid (such as gas) and power (such as electricity) from the console via the input connector 460, and the input connector 460 also includes an exhaust connection. The input connector 460 is also configured to receive and transmit electrical signals including data and / or control signals.

[0158] As described above, embodiments of the handle according to the present invention are configured to releasably engage with embodiments of the connectors of the atherectomy subsystem and the pulsed intravascular lithotripsy subsystem such that any one of such connectors can be operably connected to the handle. Figure 4B A handle assembly 400 and a connector 401 in accordance with an embodiment of the present invention are shown. The connector 401 can be an atherectomy connector (such as connector 113 of the atherectomy subsystem 160 of the system or connector 213 of the atherectomy subsystem 260) or a proximal connector (such as proximal connector 151 of the pulsed intravascular subsystem 150 or proximal connector 251 of the pulsed intravascular subsystem 250). In each case, the connectors of the atherectomy subsystem and the pulsed intravascular lithotripsy subsystem include the same proximal interface for connection to the distal interface of the handle. For example, the connector and handle interface can include complementary shapes, operable connections (such as high-pressure fluid connections), electrical connectors, other interlocking mechanisms, etc., and these aspects can be the same between the atherectomy connector of the atherectomy subsystem and the proximal connector of the pulsed intravascular lithotripsy subsystem. Figure 4BIllustrates the general orientation in which the connector 401 is operably connected to the handle 400, i.e., such that the proximal interface of the connector 401 can contact the distal interface of the handle 400, such that the handle and the connector are releasably engaged to form an operable connection therebetween, and further such that each of the atherectomy subsystem and the intravascular pulsed lithotripsy subsystem can be operably connected to the handle interchangeably. Figure 4B Also illustrates the shape, alignment features, latching features, and how the connector aligns when the two elements, the handle 400 and the connector 401, are in contact with each other (i.e., operably connected to each other). More details regarding the interface between the embodiments of the handle and the connector are provided in U.S. Application No. 63545060.

[0159] Atherectomy Subsystem:

[0160] The atherectomy component (i.e., the atherectomy subsystem) is a catheter-based system configured to remove plaque accumulations within a blood vessel. The atherectomy component can be configured to perform any type of suitable atherectomy procedure. Atherectomy procedures of interest that can be implemented by embodiments of the system of the present invention can include, but are not limited to: excision atherectomy, laser ablation atherectomy, orbital atherectomy, and rotational atherectomy, or otherwise utilize ultrasound, electrohydraulic lithotripsy (EHL) cavitation emitters, and / or mechanical conduction of a guide wire to create a hole through plaque accumulations such as chronic total occlusions.

[0161] In some cases, the atherectomy tool includes a rotating device (e.g., a rotating assembly) that converts the output (e.g., voltage, current, pressure, or flow) of an oscillator provided by the handle into rotational motion. This rotational motion is transmitted to a flexible drive shaft (e.g., a lateral transmission assembly) having a proximal end and a distal end. A portion of the proximal end is attached to a rotating motor, and a portion of the distal end has an abrasive tip. When the motor rotates, the motor transmits its rotational motion through the drive shaft to the attached abrasive tip. For stability, the drive shaft and the abrasive tip can have a guide wire passing through the drive shaft and the abrasive tip. Additionally, there can be a pusher that advances the abrasive tip through the lesion or retracts the lesion. The atherectomy portion of the system can have multiple sensors, including current sensing, rotational position, speed, and / or acceleration sensing, heat and / or temperature sensing, linear position sensing, torque sensing, pressure, and / or flow sensing. In other cases, the atherectomy tool includes a rotating device (e.g., a rotating assembly) that converts the output (e.g., voltage, current, pressure, or flow) of a switch (e.g., provided by the handle and ultimately by a console) into orbital motion, i.e., such that the atherectomy tool moves in an orbit to grind through the lesion.

[0162] Rotary or orbital atherectomy tools / subsystems that can be components of the system of the present invention include, but are not limited to, those described in U.S. Patent Nos. 11,559,324; 11,478,270; 11,413,063; 11,382,652; 11,331,119; 11,291,468; 11,172,956; 11,096,716; 11,090,079; 11,065,030; 10,893,882; 10,729,460; 10,441,311; 10,405,879; 10,405,878; 9,084,627; 9,554,823; and U.S. Published Patent Application Publication Nos. 2022 / 0387074; 2022 / 0240975; 2022 / 0142667; 2022 / 0133347; 2022 / 0133346; 2022 / 0061879; 2021 / 0322052; 2021 / 0251653; 2021 / 0145474; 2021 / 0077143; 2020 / 0397464; 2020 / 0397463; 2020 / 0315653; 2020 / 0229844; 2020 / 0222075; 2020 / 0214735; 2019 / 0365412; 2019 / 0343551; 2019 / 0307483; 2019 / 0262034; 2019 / 0262032; 2019 / 02602022; 2019 / 0201052; 2019 / 0201051; 2017 / 0135719; 2016 / 157886; 2016 / 0022307; 2014 / 0277010; 2014 / 0005699; 2013 / 0086588; the disclosures of which are incorporated herein by reference.

[0163] In some embodiments, the atherectomy subsystem includes an atherectomy tool. Such an atherectomy tool can include a rotary atherectomy tool or an orbital atherectomy tool, or one or more of a laser tool, an ultrasound tool, a shock wave lithotripsy (EHL) cavitation emitter tool, or a mechanical conduction tool. In an embodiment, the atherectomy tool is present in the distal region of the system and can be configured to grind within the lesion. In some cases, the atherectomy tool is configured to pass through the lesion, such as an occlusive lesion or a chronic total occlusion (CTO). In other cases, the atherectomy tool is configured to create a new channel within the occlusion. For example, the atherectomy tool can be configured to drill a hole at the occlusion. As described above, the atherectomy tool can be a grinding head, such as a grinding abrasive head.

[0164] As described above, the atherectomy subsystem may include a rotating assembly configured to generate rotational energy, such as a rotary motor. In an embodiment, the rotating assembly (e.g., via a handle and a connecting cable) is operatively connected to a console or a potential energy source of the console. In an embodiment, the rotating assembly is configured to convert the energy transmitted from the console into rotational energy.

[0165] The atherectomy subsystem may further include a lateral transmission assembly configured to propagate the rotational energy from the rotating assembly to the atherectomy tool. Such a lateral transmission assembly may be positioned at the distal end of the rotating assembly and the proximal end of the atherectomy tool. In an embodiment, the lateral transmission assembly includes a rotary drive shaft, such as a flexible drive shaft. The lateral transmission assembly may be configured to receive a guide wire, e.g., through a guide wire lumen. Such a guide wire and guide wire lumen may include a fluid bearing, i.e., such that fluid is present within the guide wire lumen of the atherectomy subsystem, and the fluid bearing is configured for heat dissipation. When present, the guide wire may be configured to provide stability to the lateral transmission assembly while propagating the rotational energy from the rotating assembly to the atherectomy tool. When present, the guide wire may also be configured such that the atherectomy subsystem includes an atherectomy tool configured to drill through a lesion using mechanical conduction of the guide wire.

[0166] In some cases, the atherectomy subsystem includes a pusher configured to advance and retract the atherectomy tool in distal and proximal directions (e.g., toward and away from a lesion, such as a chronic total occlusion). The pusher may be configured to pulse the atherectomy tool into and out of an occluded lesion. Such pusher action may utilize pulsed energy transmitted from the handle. In an embodiment, the atherectomy subsystem further includes a filter located at the distal end of the atherectomy tool, and such a filter is configured to protect the vasculature from distal embolization.

[0167] As described above, embodiments of the atherectomy subsystem further include sensors, where such sensors may be configured to sense one or more of current, rotational position, speed, acceleration, temperature, linear position, torque, pressure, or flow. In an embodiment, the sensor is configured to sense a current associated with interfacing the atherectomy subsystem and an occluded lesion. That is, it may sense a current response associated with the atherectomy subsystem penetrating a lesion (e.g., an occlusion including a calcified plaque).

[0168] Intravascular Pulse Lithotripsy Subsystem:

[0169] The intravascular pulsed lithotripsy subsystem of the system of the present invention is configured to apply pulsed energy to calcified tissue, such as calcified vascular tissue. In embodiments, these subsystems can include a proximal connector configured to operably connect a balloon catheter assembly to a pulse generator and convert the first pulsed energy generated by the pulse generator into second pulsed energy. In embodiments, as described herein, for example, the pulse generator includes a potential energy source, a console, and a handle. The intravascular pulsed lithotripsy subsystem further includes a distal balloon and a catheter component, wherein the catheter component includes a fluid passage operably positioned between the proximal connector and the distal balloon, and the passage is configured to propagate the second pulsed energy from the proximal connector along the fluid channel to the distal balloon.

[0170] As used herein, frequency refers to the number of full pressure pulse cycles (peak to peak) per unit time; duty cycle refers to the percentage of time within a single pressure cycle allocated to the high-pressure portion; and amplitude is the difference between the maximum and minimum pressures. Since the energy delivered by the balloon to the internal tissue is pulsed, this energy varies (e.g., increases and decreases) at a specific or determined frequency and duty cycle. During intravascular pulsed lithotripsy treatment, blood flow distal to the distal balloon may be blocked, which may limit the treatment time. To achieve successful treatment within this time, the pulse frequency and amplitude must apply sufficient energy to the tissue to treat it. Although the frequency of the pulsed energy applied by the balloon to the tissue associated with the balloon may vary, in some cases, this frequency is high, for example, from 0 to 100 Hz, such as 0 to 25 Hz in some examples. Similarly, the duty cycle of the pulsed energy applied by the balloon to the tissue can vary from 10% to 100% in some cases, such as 60% to 80%. The amplitude of the pulsed energy applied by the balloon to the tissue can vary within an internal balloon pressure range of 0 - 100 ATM in some cases, such as 0 - 30 ATM. In some cases, during a given procedure, the frequency may vary during the procedure, i.e., not remain constant as expected.

[0171] When pulsed energy is applied to the luminal vascular tissue of a lesion, the pulsed energy can effectively treat the lesion tissue (such as CP tissue) while reducing the negative impact on surrounding healthy tissue. Important characteristics of the pulsed energy for achieving successful treatment may include the frequency and amplitude of the pulsed energy delivered. In embodiments, such pulsed energy can cause safe, controllable, and fatigue fracture of the CP lesion. Fatigue fracture refers to the process of cyclically applying a load to a structure at a pressure below that which causes instantaneous failure. Traditional treatments apply dangerous high-pressure bursts to the blood vessel, which may cause vascular dissection and perforation, while intravascular pulsed lithotripsy can use low-pressure high-frequency oscillations in the balloon to initiate low-pressure fatigue fracture of the CP lesion.

[0172] The above-described embodiments are dynamic physical systems where the output of the system (e.g., actual frequency, duty cycle, and amplitude) is controlled by the system input (e.g., desired frequency, duty cycle, and amplitude) and system characteristics (e.g., catheter length, friction, and flow channel lumen diameter). Embodiments of the present system are configured to generate controlled mechanical lithotripsy pulses in an angioplasty balloon such that the system output tracks the commanded or desired input signal with minimal attenuation in some cases. Signal attenuation refers to the reduction in the amplitude of the system output relative to the input due to the characteristics of the physical system. For successful treatment, minimal attenuation is required, where the output pulse energy remains substantially similar to the input pulse energy in terms of, for example, frequency, duty cycle, and / or amplitude as it propagates from the system input (e.g., proximal connector) to the system output (e.g., distal balloon). Thus, in some cases, any change in frequency (if present) between the proximal connector and the distal balloon will be 30% or less, e.g., 5% or less. In some cases, any change in the amplitude of the pulse energy (if present) between the proximal connector and the distal balloon will be 30% or less, e.g., 5% or less. In some cases, any change in the duty cycle of the pulse energy (if present) between the proximal connector and the distal balloon will be 30% or less, e.g., 5%.

[0173] As described above, according to embodiments of the present invention, a pulsed intravascular lithotripsy subsystem representative of a mechanical system is operably connected to a pulse generator. In an embodiment, as described herein, for example, the pulse generator includes a potential energy source, a console, and a handle. The pulse generator includes components configured to generate a first pulse energy that can be converted by a proximal connector into a second pulse energy, e.g., as described in more detail below. The proximal connector is configured to receive the first pulse energy provided by the pulse generator and convert it into a second pulse energy that can be received by the distal balloon to apply the second pulse energy to an internal tissue location, as described herein, e.g., for DBA or pulsed intravascular lithotripsy applications, and for final post-dilation of a blood vessel, e.g., in a single treatment including both applications. That is, embodiments of the present invention can first be used to apply a pressure pulse to the luminal tissue (such as a blood vessel) to rupture calcium (i.e., tissue affected by CP), and then use a conventional non-compliant balloon post-dilation to dilate the blood vessel. Embodiments of aspects of the pulsed intravascular lithotripsy subsystem are now described in more detail.

[0174] The first pulse energy can vary as needed, and examples of the first pulse energy include, but are not limited to: pulsed pressure energy, pulsed mechanical energy, pulsed electromagnetic energy, etc. Since the first pulse energy is pulsed, the amplitude of the first energy will vary or be adjusted over time, for example, vary or be adjusted according to a determined or known (e.g., predetermined) frequency, according to the user and / or according to the treatment progress. Although the frequency of the first pulse energy can vary, in some cases, the frequency is high, and in some cases the frequency is greater than 0 to 100 Hz, such as 2 Hz to 25 Hz. As described below, as needed, during a given procedure, the frequency amplitude and / or duty cycle can vary during the procedure, i.e., not remain constant (e.g., as described below in connection with Figure 6 ). The frequency, amplitude, and / or duty cycle can also vary according to the type of catheter and distal balloon (e.g., balloon length and / or diameter, shaft length), type of treatment, lesion hardness, lesion density (e.g., acquired by computed tomography or intravascular imaging), or lesion morphology, etc. The frequency, amplitude, and / or duty cycle can also vary according to user input, negative feedback of measurement results, and / or positive feedback of system modeling.

[0175] As described herein, the pulse generator of an embodiment of the present invention includes a potential energy source configured to provide energy, and the energy can be regulated by a regulator and an oscillator as needed to provide the pulsed aspect of the first pulse energy. Any suitable potential energy source can be employed. Examples of potential energy sources include voltage sources, pressure sources, electromagnetic sources, electric field sources, chemical sources, laser sources, etc. In some embodiments, the potential energy source is a pressure source, and examples of suitable pressure sources include, but are not limited to: compressed cylinders, compressors, etc. When needed, the potential energy source can be operably coupled to a regulator that is used to regulate the energy into a suitable form such that the oscillator can further act on the energy. For example, when the potential energy source is a high-pressure gas source (e.g., can be used in a gas pulse generator), the regulator can be used to regulate the pressure of the gas to a suitable value that can be input into the oscillator. In addition to the potential energy source and the regulator, the pulse generator can further include an oscillator. In this case, the oscillator is used to adjust the amplitude and time of the potential energy from the potential energy source to provide the desired first pulse energy.

[0176] The different components of the pulse generator can be present within a single housing or can be provided as two or more distinct, operably connected units. In some cases, at least some of the components of the pulse generator are present in a unit configured to be handheld, such as a handle. In such cases, the handheld component (such as a handle) is designed to be held and operated by an adult's hand. Although the dimensional specifications of such handheld units can vary as needed, in some cases, the overall diameter and / or width of such units is from 20 mm to 150 mm, such as from 50 mm to 80 mm, the length is from 50 mm to 300 mm, such as from 100 mm to 200 mm, and the mass is from 100 g to 2000 g, such as from 500 g to 750 g. For example, the pulse generator can include a first console component (such as the console described herein), which houses or is operably connected to a source of potential energy and houses a regulator; and also includes a second handheld actuator, namely the handle described herein, which includes an oscillator and an actuator for the oscillator (such as a manipulable button). As needed, the handheld actuator can include an electrical connector for providing an electrical connection to various components of the intravascular pulse lithotripsy subsystem. For example, this electrical connector can be used to receive data regarding diaphragm position, memory, and / or pressure and to power these sensors, and such examples will be further described herein.

[0177] In some cases, at least some of the pulse generator portion is present in a mountable unit configured to be positioned or secured on an operating table near a patient such that a doctor can treat the patient without being physically present. In such cases, the mountable unit is designed to be easily clamped, secured, or independently stable on the operating table and can be operated by a remote control unit. In such cases, the mountable unit can include a communicator that provides communication between the unit and the remote control unit, and such communicator can be implemented by any desired hardware and / or software configuration and can be configured to communicate using a wired or wireless (such as Bluetooth or radio frequency) protocol. The pulse generator employed in the system of the present invention can be configured to be reusable or single-use as needed. The pulse generator employed in the system of the present invention can be configured to receive a sterile sheath such that the sterile area of the operating room is not contaminated when using the generator. More details regarding the pulse generator and its components (such as a source of potential energy, an oscillator, a regulator, etc.) that can be used in embodiments of the present invention are provided in U.S. Patent No. 11464949, U.S. Published Patent Application Publication No. 20200046949, and pending PCT Application Serial No. PCT / US2002 / 055458 and pending PCT Application Serial No. PCT / US20022 / 014785; the disclosures of which are incorporated herein by reference.

[0178] As described above, the intravascular pulsed lithotripsy subsystem of the present invention includes a proximal connector, a catheter, and a distal balloon. The proximal connector is configured to receive a first pulsed energy from a pulse generator and convert it into a second pulsed energy, which can propagate along the length of the catheter, for example, along the fluid (e.g., liquid) passageway of the catheter to the distal balloon. When the proximal connector converts the first pulsed energy into the second pulsed energy, it changes the form of the pulsed energy in some way. Examples of the changes that the proximal connector can make to the energy form include, but are not limited to: converting gas pressure and / or gas flow into liquid pressure and / or liquid flow, converting mechanical potential and / or mechanical kinetic energy into fluid pressure and / or fluid flow, converting optical potential and / or optical kinetic energy into fluid pressure and / or fluid flow, converting electric field potential and / or electric field kinetic energy into fluid pressure and / or fluid flow, converting magnetic potential and / or magnetic kinetic energy into fluid pressure and / or fluid flow, etc. For example, when the first pulsed energy is a pneumatic first pulsed energy, the proximal connector can be configured to convert the pneumatic first pulsed energy into a second hydraulic pulsed energy, which can propagate from the proximal end to the distal end of the intravascular pulsed lithotripsy subsystem, which is an example of the conversion of pulsed energy from gas to liquid. In some cases, the intravascular pulsed lithotripsy subsystem propagates the second pulsed energy from the proximal end to the distal end with little or no attenuation, where any attenuation (if any) has an amplitude of no more than 30%, and in some cases no more than 5%, as described above.

[0179] In some cases, the intravascular pulsed lithotripsy subsystem includes: (i) a proximal connector that operably connects the intravascular pulsed lithotripsy subsystem to a pulse generator and is configured to convert a first pulsed energy generated by the pulse generator into a second pulsed energy; (ii) a distal balloon; and (iii) a catheter component that includes a fluid passageway that is operably positioned between the proximal connector and the distal balloon.

[0180] The proximal connector is a component of the components located at the proximal end of the intravascular pulsed lithotripsy subsystem. For example, at or near the proximal end (e.g., within 1 cm of the proximal end or closer), where the proximal connector is configured to operably connect the intravascular pulsed lithotripsy subsystem to a pulse generator and convert the first pulse energy into the second pulse energy, such as as described above. The manner in which the proximal connector is operably connected to the pulse generator (i.e., the manner in which the proximal connector is operably connected to the handle) can vary as needed, where a given type of connector can be a press-fit connector, a latch connector, a screw connector, a threaded connector, a magnetic connector, a push-on connection connector, a Y-lock connector, a claw clip connector, a washer connector, a socket connector, a flange connector, a cam groove socket, a quick-connect connector, etc., where an aligner or a stopper can be used as needed to provide a connection that positions the proximal connector relative to the pressure generator and / or the electrical connector repeatably and accurately. As described above, this operable connection between the proximal connector and the handle is configured to be the same as the operable connection for the connector and the handle used to connect the atherectomy subsystem. For example, both the proximal connector and the connector of the atherectomy subsystem can include the same shape and the same latch mechanism to hold these connectors in place relative to the handle. That is, the system of the present invention utilizes a unified interface in terms of the atherectomy and intravascular pulsed lithotripsy subsystems, such that each subsystem can be operably connected to the handle interchangeably.

[0181] As described above, in some cases, the conversion is a fluid-to-fluid energy conversion. For example, where the first pulse energy is pneumatic pulse energy and the second pulse energy is hydraulic pulse energy. In this case, the proximal connector can include a proximal chamber and a distal chamber separated by a membrane, for example, where the membrane hermetically seals the distal chamber from the proximal chamber. The proximal chamber can be configured to receive the pneumatic pulse energy from the pulse generator. The volume of the proximal chamber can vary, in some cases being from 0.1 mL to 100 mL, such as 1 mL to 4 mL, where in some cases the proximal chamber is occupied by gas. In some cases, the proximal chamber forms a chamber of minimum volume while still being large enough to accommodate the volume change required to fill the distal balloon. In this case, the time required to fill the chamber of this minimum volume to a certain pressure is minimized, which enables an increase in the frequency of intravascular pulsed lithotripsy procedures. The distal chamber is fluid-coupled to the fluid passage of the catheter component. The volume of the distal chamber can vary, in some cases being from 0.1 mL to 100 mL, such as 1 mL to 4 mL, where in some cases the distal chamber is occupied by liquid.

[0182] The membrane separating the proximal chamber and the distal chamber is configured to move in response to a first pulse energy, and in the process, generate a second pulse energy in the distal chamber of the connector. The size of the membrane can vary, where in some cases, the area of the membrane is 100 mm 2 to 5000 mm 2 , such as 500 mm 2 to 2000 mm 2 . The membrane can be made of any suitable elastic (e.g., flexible) material, where in some cases, the hardness of the material is Shore 10A to Shore 90A, such as Shore 50A, and the thickness is 0.5 mm to 5 mm, such as 1.0 mm to 2.5 mm. Examples of suitable membrane materials include, but are not limited to: silicone, rubber, etc., and can be reinforced by adding reinforcing components (such as woven fabrics) in some examples. In cases where needed, a biasing member (such as a spring) can be provided to provide a default or reference membrane position. For example, a spring can be set on the distal chamber side of the membrane, and when the force is removed from the proximal chamber side of the membrane, the spring will push the membrane back to the initial position. In other cases, the system can be controlled such that the pulse generator provides a constant pressure (although very small, such as 0.1 atm to 2 atm) to the proximal chamber to offset the pre-filled pressure. This reaction force will enable the diaphragm to be set in place to initiate pulsed intravascular lithotripsy treatment and start measurements.

[0183] Although the form of the proximal connector of the embodiment can vary, in some cases, the proximal chamber is defined by a proximal flange, and the distal chamber is defined by a distal flange, where the proximal flange and the distal flange are positioned on both sides of the membrane to define the proximal chamber and the distal chamber, and the two chambers can be sealed (e.g., gas-tight) from each other by the separating membrane. In this case, the proximal flange can include a proximal port perpendicular to (e.g., axially to) the proximal flange, and the proximal port is configured to receive the first pulse energy generated by the pulse generator, such as a gas pulse energy. Although the size of the proximal port can vary as needed, in some cases, the outer diameter of the port is 1 mm to 30 mm, such as 3 mm to 8 mm, and the inner diameter is 1 mm - 30 mm, such as 2 mm to 7 mm. When the proximal flange has a proximal port, the length of the port is 1 mm to 50 mm, such as 3 mm to 10 mm. In these cases, the distal flange can include a distal port that fluidly couples the distal chamber to the fluid passage of the catheter. Although the size of the distal port can vary as needed, in some cases, the lumen diameter of the port is 0.1 mm to 10 mm, such as 1 mm to 3 mm.

[0184] In the case where the proximal chamber includes a proximal port, the proximal chamber is fluidly coupled to the port. In such a case, the junction between the proximal port and the proximal chamber may include a nozzle and / or a diffuser, and in some cases, the nozzle and / or the diffuser may be geometrically formed by a proximal flange. In such a case, the nozzle or the diffuser may increase or decrease the flow rate by sacrificing fluid pressure. As the flow rate increases or decreases, the characteristics of energy conversion are improved, such as the rise time or smoothness of energy conversion. In the case of pneumatic flow, the velocity of the gas may be high enough to cause compressible fluid phenomena such as sonic or supersonic flow. In such a case, specialized flow nozzles (such as converging-diverging nozzles) may be used to optimize the flow rate.

[0185] In cases where needed, the proximal connector may include one or more sensors, e.g., configured to provide data regarding one or more components of the connector and / or the balloon catheter assembly. Any suitable type of sensor may be included in the proximal connector, and sensors of interest include but are not limited to: pressure sensors, position sensors, displacement sensors, proximity sensors, flow sensors, temperature sensors, etc. In some examples, the proximal connector includes a pressure sensor operably coupled to the distal chamber. In such a case, the pressure sensor may detect the pressure of the liquid in the distal chamber and changes in the pressure. When a pressure sensor is included, any suitable type of pressure sensor may be employed, and examples of pressure sensors that may be used include but are not limited to: resistive, capacitive, piezoelectric, optical, and MEMS-based pressure sensors, etc. In some cases, these pressure sensors may measure the pressure at the proximal connector, and in other cases, the pressure may be read at or along the length of the catheter and / or the distal balloon. For example, to measure the pressure at the distal balloon, a fiber optic-based sensor may be used. In some examples, the proximal connector includes a membrane position sensor configured to provide spatial data regarding the membrane position at a given time (e.g., during subsystem use). When present, any suitable membrane position sensor may be employed. In some examples, the membrane position sensor is a Hall sensor, e.g., it may be used in combination with one or more magnets (such as permanent magnets or electromagnets) located at a fixed position relative to the membrane (such as a fixed position of the proximal connector), such that the one or more fixed magnets are positioned to modulate the voltage of the Hall sensor once the membrane moves. In other cases, the membrane position sensor may be an optical sensor, an electric field potential sensor, a resistive sensor, a magnetic sensor, an angular sensor, or an acceleration sensor. Additionally, any combination of these sensors may be used to collect position data of the membrane or diaphragm. In cases where a combination of membrane position sensors is employed, e.g., to ensure that the sensors provide correct data at various frequencies, the sensor data may be combined through "sensor fusion" techniques such as those known in the art. When a membrane position sensor is present, it may be used for various different purposes, such as for evaluating vascular compliance and treatment (as described below), evaluating the proper filling of the proximal connector, catheter, and / or distal balloon, providing a method for evaluating whether the membrane has been stretched beyond an expected threshold, etc. Methods of manufacturing the membrane sensor may include but are not limited to: adhesives, direct printing, welding, embedding, etc.

[0186] In cases where needed, the proximal connector may further include electrical components. The electrical components may be configured to perform a variety of functions, such as but not limited to powering one or more sensors, controlling one or more sensors, storing data obtained from one or more sensors, transmitting sensor data from one or more sensors to another location, storing information about the balloon catheter assembly, writing and / or reading data, etc. The electrical components may vary and, in some cases, may include circuitry and / or memory. When memory is present, it may store various different types of information, including but not limited to: information about the balloon catheter assembly and / or its components (such as the distal balloon), such as expiration date, lot number, balloon size (such as balloon diameter and length), balloon rated burst pressure and nominal pressure, cycle limits (such as the number of cycles the balloon is rated to allow), and the number of cycles used, allowable pulse frequency or duration, previous usage, balloon reference pressure-volume curve, and / or usage indication, etc. When the electrical components are present, they may also include connectors, such as for operably connecting the electrical components to a pulse generator. The electrical components may be present in any suitable configuration, such as a printed circuit board, including a flexible printed circuit board. In some cases, the sensors may wirelessly transmit data, such as via Bluetooth RF transmission.

[0187] For example, as described above, the various components of the proximal connector may be present in a housing or overmolded material, such as a housing or overmolded material configured to protect the proximal connector components, for example, during an accidental drop or during packaging. The housing (if present) may be made of a suitable rigid material (such as a polymeric material) and may be transparent or opaque as needed.

[0188] As described above, the intravascular pulsed lithotripsy subsystem may include catheter components positioned between the proximal connector and the distal balloon. The catheter components are configured to propagate or deliver the second pulse energy from the proximal connector to the distal balloon, for example, as described above, with the lowest attenuation (if any attenuation exists) during propagation or delivery. The catheter components include a portion configured to serve as a catheter (such as a shaft) such that this portion can be introduced into the lumen of a human or other animal (such as a mammal). Although the size of this portion may vary, in some cases, the outer diameter (OD) of this catheter portion is from 1.50 mm to 2.50 mm, such as from 1.75 mm to 2.20 mm.

[0189] Although the structure of the catheter component can vary, in some cases, the catheter component includes a proximal flexible tube; a distal catheter shaft (i.e., the catheter portion as described above); and a connector that connects the distal end of the proximal flexible tube to the proximal end of the distal catheter shaft. The proximal flexible tube is made of a flexible material, such as braided or unbraided polyvinyl chloride (PVC), silicone, polycarbonate (PC), etc., where the size of the tube can vary. In some cases, the flexible tube has a lumen with a diameter of 0.1 mm to 10 mm (such as 1 mm to 3 mm) and a wall thickness of 0.1 mm to 5 mm (such as 0.5 mm to 2 mm). The length of the proximal flexible tube can also vary, being 1 cm to 100 cm in some examples, such as 5 cm to 20 cm.

[0190] The distal catheter shaft can also vary. The distal catheter shaft can be made of any suitable physiologically acceptable material, including but not limited to polyimide (such as polyimide braid), or polyimide-based materials, etc. In some cases, the length of the distal catheter shaft is from 10 cm to 5 m, for example, from 100 cm to 300 cm. The outer diameter of the distal catheter shaft can also vary, and in some examples, it is from 1.50 to 2.50, for example, from 1.75 mm to 2.20 mm. The distal catheter shaft can include a first liquid passage lumen, and the size of the first liquid passage lumen can vary. In some cases, the diameter of the first liquid passage lumen is from 1.3 mm to 2.2 mm, for example, from 1.6 mm to 2.1 mm. The first liquid passage can include one or more openings at the distal end for establishing liquid communication between the inside of the liquid passage lumen and the inside of the distal balloon. When there are one or more openings, they are configured to cause substantially no attenuation, and in some cases, no attenuation at all, of the second pulse energy as it enters the balloon from the liquid passage. In some cases, these openings can be configured as nozzles and / or diffusers. In such cases, the nozzle or diffuser can increase or decrease the flow rate by sacrificing fluid pressure. As the flow rate increases or decreases, the characteristics of balloon inflation may change, such as rise time, impact, force, etc. The distal catheter shaft can also include a second guide wire lumen. When there is a second guide wire lumen, its size can vary, and in some cases, the diameter of the guide wire lumen is from 0.25 mm to 0.5 mm, for example, from 0.37 mm to 0.42 mm. The distal catheter shaft can be configured to pass through the entire length of the distal balloon or end at the proximal connection of the distal balloon. In the case where the distal catheter shaft spans the entire length of the balloon, the distal catheter shaft can be provided with ports to achieve fluid communication between the inside of the catheter shaft and the distal balloon. The ports can be made using a laser process or other special processing techniques. The pattern or distribution of the ports in the catheter shaft can be arranged to ensure that the distal catheter shaft has the required stiffness to push through a narrow calcified lesion and prevent kinking, but still has the flexibility to pass through a long and tortuous lesion. The diameter of the port holes can be from 0.05 mm to 1 mm, for example, 0.2 mm. These holes can form a spiral or linear array pattern or be arranged along the internal braiding of the material. The number of holes can be between 100 and 500, for example, 200. The total area of these holes should exceed the cross-sectional area of the flow channel lumen. By providing ports along the entire length of the distal catheter shaft where the distal balloon is located, the entire balloon surface receives an equal amount of pulse energy during treatment. This configuration ensures that if a part of the balloon is compressed, that part and the other parts of the balloon will receive an equal amount of energy. The disadvantage of this configuration is that the profile (i.e., the total diameter of the distal catheter shaft) is larger, making it more difficult to pass through a narrow lesion or drill through the narrow volume during atherectomy. To narrow the distal catheter shaft, the distal catheter shaft can end at the proximal balloon connection.In this case, only the length of the guidewire lumen passes through the balloon. In this case, the proximal neck diameter of the balloon can match the distal catheter shaft, and the distal neck diameter matches the guidewire lumen. Since the diameter of the guidewire lumen is smaller than the diameter of the distal catheter shaft, the passage profile of this configuration can be improved compared to, for example, the previously described configuration. However, there is only one port for delivering fluid from the distal catheter shaft to the balloon, which may result in uneven distribution of energy to the balloon wall and the calcified lesion. These two configurations can be used for different situations, such as for different indications, anatomical locations, etc.

[0191] There are also connectors in the catheter components of these embodiments that connect the distal end of the proximal flexible tube to the proximal end of the distal catheter shaft. The connectors can vary as needed. In some examples, the connector includes a first branch and a second branch, the first branch being configured to provide a guidewire passage to the guidewire channel of the catheter shaft, and the second branch being configured to fluidly couple the lumen of the proximal flexible tube and the fluid passage lumen of the distal catheter shaft. An example of a suitable connector is a Y-connector or a similar connector, and in some embodiments, the connector includes a sufficient number of ports such that the lateral transfer assembly of the atherectomy subsystem can be coupled to the catheter of the intravascular pulsed lithotripsy subsystem. In such an embodiment, the catheter of the intravascular pulsed lithotripsy subsystem can include one or more channels (e.g., lumens) for accommodating aspects of the lateral transfer assembly of the atherectomy subsystem. For example, the catheter can include a channel or lumen that accommodates a guidewire operably connected to a rotational assembly and an atherectomy tool. For example, such a configuration can include a fluid bearing for the lateral transfer assembly of the atherectomy subsystem.

[0192] As described above, the intravascular pulsed lithotripsy subsystem further includes a distal balloon. Any suitable balloon can be used. Suitable balloons include, but are not limited to, standard angioplasty balloons such as compliant and non-compliant angioplasty balloons. In one embodiment, the balloon is a composite balloon including two different layers, which two layers include a non-compliant layer and a compliant layer. To describe the improvement of the structure of the current composite balloon relative to the prior art, these two layers of the composite balloon will be described as separate units. Non-compliant angioplasty balloons are commonly used in percutaneous procedures because the set diameter of the balloon evenly distributes its force over the surrounding blood vessel without bulging into the softer, healthy tissue surrounding the stenosis. When the non-compliant balloon material is pressurized, the balloon first fills, creating a low-pressure and high-stretch state. When the non-compliant balloon reaches its nominal diameter, the balloon pressure significantly increases while the corresponding stretch is lower. When the pressure inside the balloon is released, the balloon remains in its nominal stretched state due to the lack of elasticity of the balloon. This lack of elasticity is problematic for three reasons: (1) the deflated balloon may remain inflated unless a vacuum is created, which may block blood flow; (2) this may make it difficult to withdraw the balloon catheter through the sheath after treatment; (3) during pulsed treatment, the balloon does not force fluid out during the low-pressure phase, which prevents the desired stress relaxation in the surrounding tissue. Thus, non-compliant balloons are useful at high pressure but have limitations at low pressure. Compliant angioplasty balloons typically have a linear pressure-stretch curve. The use of these balloons in percutaneous procedures is limited because the balloons do not stretch evenly around atherosclerotic segments, which may damage the healthy soft tissue surrounding the hardened lesion tissue. With a compliant balloon, the balloon pressure typically increases linearly. Compared to non-compliant balloons, the initial filling region of a compliant balloon is "shorter", and thus, when the pressure in the balloon is released, the balloon returns to its initial stretched state without the need for additional vacuum. This return to the initial state is beneficial for certain intravascular pulsed lithotripsy procedures because once returned to the initial stretched state, blood flow immediately resumes and the balloon can then be more easily withdrawn through the sheath. Additionally, during pulsed angioplasty, the compliance of the balloon serves as a driving force to force fluid out of the balloon, which is necessary to allow the surrounding tissue to relax under low stress during the low-pressure phase. Thus, compliant balloons are helpful at low pressure but have limited ability to treat at high pressure. The use of non-compliant and compliant angioplasty balloons alone is not optimal for all stages of pulsed and standard percutaneous angioplasty. However, together as a composite, they can meet the important requirements of both treatments. In one embodiment of the composite angioplasty balloon, the non-flexible balloon is covered with a flexible sheath to achieve "arrowhead" pressure stretch, for example, as further described in the pending PCT application serial number PCT / US2002 / 055458; the disclosure of which is incorporated herein by reference.The compliant layer can be a rubber, silicone, polyurethane, or nitinol material, or another material that can stretch 100 - 500% before failure, can withstand thousands of cycles before failure, and produces minimal plastic deformation (if any) during inflation. During use, an exemplary composite balloon operates as follows. During the low-pressure phase, the compliant material dominates the balloon's response. The composite balloon follows the curve of the compliant material until the balloon stretch intersects with the non-compliant balloon stretch. At this intersection and higher pressures, the non-compliant material dominates the balloon's response. Once the pressure is released, the balloon immediately returns to the initial or zero-stretch state in response to the arrow. This exemplary composite balloon has the low-pressure advantages of a compliant angioplasty balloon and the high-pressure advantages of a non-compliant angioplasty balloon. Other advantages include self-folding and deflation of the balloon, relief of tears and pinholes, increased oscillation frequency during pulsed angioplasty, and improved ability of the balloon to withstand forces applied in a certain direction (such as longitudinally) or otherwise when passing through lesions. More details regarding composite angioplasty balloons and the like used in embodiments of the present invention can be found in U.S. Patent No. 11464949, U.S. Published Patent Application Publication No. 20200046949, and pending PCT Application Serial No. PCT / US2020 / 055458 and pending PCT Application Serial No. PCT / US2022 / 014785; the disclosures of which are incorporated herein by reference.

[0193] In other cases, the balloon can have external features that create pulsed stress concentrations in the surrounding material. These features can be incorporated into the overall shape of the balloon (i.e., when pressurized, the balloon assumes the shape of the original mold), or can be achieved via additional components (such as strips or cages) around the balloon. In some cases, the additional components traverse the length of the balloon (i.e., from the proximal end to the distal end of the balloon). In such cases, stress concentrations are created in the surrounding material such that radial ruptures are produced in the calcium structure. In other cases, the additional components traverse the balloon circumferentially such that longitudinal ruptures are formed in the calcium structure as the balloon elongates during each pulse. Additionally, the additional components can be orthogonally distributed, thereby creating both radial and longitudinal stress concentrations in the surrounding material. Thus, both longitudinal and radial ruptures can be produced, achieving complete lysis of the calcified material.

[0194] The intravascular pulsed lithotripsy subsystem may or may not be “sealed”. In some cases, the intravascular pulsed lithotripsy subsystem is unsealed, such that during use, fluid (e.g., liquid) can be introduced into the liquid passageways of the assembly, and / or gas can be expelled from the subsystem (e.g., via defoaming). In other cases, the intravascular pulsed lithotripsy subsystem is a sealed or enclosed assembly such that the liquid passageways and the distal balloon are pre-filled with liquid prior to use, and the liquid is sealed within the assembly. In both cases, the liquid introduced into the lumen(s) and the distal balloon can vary, and in some cases, the liquid is saline. Where needed, the liquid can include a suitable contrast agent, examples of which include but are not limited to radiopaque contrast agents such as, but not limited to, iodine contrast agents, barium contrast agents, etc.

[0195] In some cases, the above-described embodiments can be configured such that the intravascular pulsed lithotripsy procedure can be performed fully autonomously and / or remotely. In such cases, the catheter and distal balloon can be inserted into the patient manually or using a robotic catheter system (as described in published application WO 2010 / 025338, the disclosure of which is incorporated herein by reference). Through such a subsystem, devices such as guidewires, catheters, and distal balloons can be advanced to the lesion site, and once at the lesion site, the balloon can be inflated or deflated. Through the above-described embodiments, the balloon can be pre-filled with fluid such that the user does not need to fill the balloon prior to pressurization. In other cases, a composite balloon embodiment can be used to ensure that the balloon deflates and collapses after the procedure for ease of removal. In such cases, the operator can sit at a console and control the procedure, including pressure, frequency, and / or duty cycle. At the same time, the operator is able to visualize the inflated balloon and the surgical effect while simultaneously viewing X-ray imaging. In some cases, feedback (e.g., visual, auditory, sensory, etc.) can be provided to the operator to indicate surgical characteristics such as volume and / or pressure changes in the balloon, frequency, duty cycle, balloon inflation, balloon position, etc.

[0196] The intravascular pulsed lithotripsy subsystem can be configured for single-use or disposable use, such that it is disposable. Prior to use, the intravascular pulsed lithotripsy subsystem can be sterilized as needed.

[0197] U.S. Patent No. 11,464,949; U.S. Published Patent Application Publication No. 2020 / 0046949; U.S. Application Serial No. 17 / 897,604; Pending PCT Application Serial No. PCT / US2019 / 027139; Pending PCT Application Serial No. PCT / US2020 / 055458; U.S. Application Serial No. 63 / 274,832; U.S. Application Serial No. 17 / 827,169; Pending PCT Application Serial No. PCT / US2002 / 014785; U.S. Application Serial No. 63 / 238,381; Pending PCT Application Serial No. PCT / US2022 / 040586; U.S. Application Serial No. 63 / 346,703; Pending PCT Application Serial No. PCT / US23 / 23533; U.S. Application Serial No. 63 / 346,704; Pending PCT Application Serial No. PCT / US23 / 22685; U.S. Application Serial No. 63 / 444,414; U.S. Application Serial No. 63 / 545,060 provide additional details regarding aspects of the systems of the present invention or components related to the systems of the present invention that can be incorporated into or used in conjunction with embodiments of the present invention, including consoles, regulators, potential energy sources, handles, manifold assemblies, oscillators, pulse generators, balloon catheter assemblies, atherectomy subsystems, intravascular pulsed lithotripsy subsystems, distal balloons, composite angioplasty balloons, etc.; the disclosures of each of them are incorporated herein by reference.

[0198] Certain Additional Features:

[0199] Certain embodiments of the systems of the present invention include an internal wire lumen present within an intravascular pulsed lithotripsy catheter (e.g., wherein a wire 257 is present within the wire lumen of a catheter 254). Such embodiments can be configured to achieve low-friction rotation even when the wire is rotating at high speeds (i.e., high-frequency rotation). Example techniques include employing a fluid bearing (using a pressurized fluid such as saline, contrast agent, or other lubricants, etc.) such that, for example, fluid is present within such wire lumens. In an embodiment, such a fluid bearing can also be used to dissipate heat generated by the rotation of the wire within the wire lumen of the catheter. Other techniques include using a self-lubricating material on the inner surface of the wire lumen of the catheter. Figure 2B In cases where needed, a Y-joint or similar joint of the intravascular pulsed lithotripsy catheter (e.g., connection 258 in) can be connected to an atherectomy subsystem, and ultimately to an atherectomy tool, to prevent aspects of the system from becoming entangled or bundled during the atherectomy grinding process, i.e., when the atherectomy tool is rotating via a lateral transfer assembly that includes a wire (i.e., when the atherectomy tool 269 is rotating due to the rotation of the wire 257).

[0200] In cases where needed, a Y-joint or similar joint of the intravascular pulsed lithotripsy catheter (e.g., connection 258 in) can be connected to an atherectomy subsystem, and ultimately to an atherectomy tool, to prevent aspects of the system from becoming entangled or bundled during the atherectomy grinding process, i.e., when the atherectomy tool is rotating via a lateral transfer assembly that includes a wire (i.e., when the atherectomy tool 269 is rotating due to the rotation of the wire 257). Figure 2B In cases where needed, a Y-joint or similar joint of the intravascular pulsed lithotripsy catheter (e.g., connection 258 in) can be connected to an atherectomy subsystem, and ultimately to an atherectomy tool, to prevent aspects of the system from becoming entangled or bundled during the atherectomy grinding process, i.e., when the atherectomy tool is rotating via a lateral transfer assembly that includes a wire (i.e., when the atherectomy tool 269 is rotating due to the rotation of the wire 257).

[0201] When needed, the gas used to supply energy to the atherectomy subsystem and / or the intravascular pulsed lithotripsy subsystem can be discharged from a switch, such as one present within the system, and vented back to the console. For example, such a configuration can help ensure that the gas is discharged into a desired volume and not into a sterile area. This routing of the exhaust gas can be achieved, for example, by including an exhaust pipe within the handle and / or the connecting cable and / or the atherectomy subsystem and / or the intravascular pulsed lithotripsy subsystem.

[0202] In an embodiment, the atherectomy subsystem utilizes rotational motion to rotate or orbit an atherectomy tool to drill or abrade a lesion. In some cases, this rotational motion is generated by a compressed gas turning a turbine. Such a turbine can be operably connected to a lateral transfer assembly that includes, for example, a guide wire. In other cases, this rotational motion is generated via a motor and a motor controller (such as an electromagnetic motor). When a motor is present, it can be located within the atherectomy subsystem, the handle, the console, or other aspects of the system embodiment. The motor controller can be located at any of the above positions but need not be directly adjacent to the motor. When a motor is present, it can be directly connected to the lateral transfer assembly or its guide wire. Alternatively, the motor can be connected to the lateral transfer assembly or its guide wire, which can be coupled to the atherectomy subsystem via a rotor connection or a gear set. That is, the lateral transfer assembly can include gears or other techniques for modulating or adjusting the rotation of a drive shaft to rotate the atherectomy tool as needed.

[0203] Embodiments of the system of the present invention can include one or more sensors configured to determine aspects of the rotation of the lateral transfer assembly and / or the atherectomy tool, such as aspects of the rotation of a guide wire operably connected to an abrading burr. Sensors of interest include optical-based rotation sensors; flow meters operably connected to a rotating component (such as a motor), for example, the outlet of a turbine operably connected to a rotating component; current sensors on a rotating component (such as on a motor (i.e., a generator) attached to the outlet of a rotating component); Hall sensors, for example, configured to sense the distance of a position of an aspect of the atherectomy subsystem (such as the atherectomy tool or the lateral transfer assembly); and so on.

[0204] Embodiments can also be configured to determine compliance measurements before, during, or after treatment using the intravascular pulsed lithotripsy subsystem. Such compliance measurements can be made based on treatment using the atherectomy subsystem, in combination with compliance measurements of the intravascular pulsed lithotripsy treatment before and after treatment.

[0205] Method

[0206] The system of the present invention can be used in a variety of applications. In some cases, the system is capable of breaking up hardened materials embedded within an elastic conduit. For the embodiments presented herein, the present disclosure describes applications related to treating hardened calcifications within arterial conduits (such as coronary or peripheral arteries), for example. However, the system and teachings are not limited to hardened calcifications or arterial conduits and can generally be applied to other applications determined by those skilled in the art. This is particularly true, for example, for cases of altering arterial compliance (such as arterial vessel compliance as described herein) or for cases involving medical interventions (such as where a previously implanted stent has subsequent blockage). The compliance of a blood vessel can be altered due to the placement of a previously implanted stent within the lumen. Data and feedback of the vascular compliance curve can be used in conjunction with future treatment and prediction techniques, such as the machine learning techniques described herein.

[0207] In some cases, various embodiments of the systems described herein are used in methods of pulsed intravascular lithotripsy, for example, using techniques with pressure oscillations having a generalized waveform (in some embodiments, harmonic or specific frequency pressure waveform oscillations) to effectively and safely break up calcified lesions during angioplasty. After performing an atherectomy procedure using the system, the system can be used in methods of pulsed intravascular lithotripsy, where such an atherectomy procedure enables aspects of the pulsed intravascular lithotripsy subsystem to access the lesion by drilling or abrading the lesion. Figures 5A - 5E The concept of DBA for treating arterial calcified plaques is shown. In DBA, for example, a catheter 516 having a balloon 502 is deployed, with the assistance of a guide wire, into a blood vessel 500 having a calcification 550 ([ Figure 5B ) using any suitable protocol (such as those known in the art).

[0208] In an embodiment of the present invention, the atherectomy subsystem of the system is first used to provide or dilate a passage through the occlusion 550. In this case, an atherectomy tool can be used to provide or dilate a passage through the occlusion 550. As described herein, the atherectomy tool can include an abrasive grinding head such that the atherectomy tool rotates to abrade aspects of the lesion 550 such that the balloon 502 can access the blood vessel 500 via the lesion 550. In embodiments of the system of the present invention that include a combined tool, the atherectomy tool can be operably connected to the balloon 502 (such as at the distal end of the balloon 502); for example, these elements can be connected by a guide wire.

[0209] Via an angioplasty balloon, the plaque is subjected to high-frequency pressure oscillations ( Figures 5C - 5D )). During the low-pressure phase of the oscillation ( Figure 5C ), the balloon pressure is reduced to near the minimum pressure required to achieve balloon inflation, typically 1 - 2 atm. During the high-pressure phase of the oscillation ( Figure 5D),The balloon is inflated to a peak pressure, which can be set by an operator (such as a doctor) or automatically determined and set by the system. The typical range of peak inflation pressure can be from above the low-pressure range to the maximum rated pressure of the balloon, which can be 25 atm or higher. The balloon is pressure cycled in this way, resulting in a periodic load on the calcified plaque 550 that is below the rupture stress of the calcified plaque but in the plastic deformation zone. The heterogeneity within the calcified plaque consists of many microcracks with sharp corners. Through the fracture mechanism described herein, Figures 5A - 5E the periodic load applied as described in generates periodic stresses at these sharp corners near the plaque microcracks and irregular surfaces. This periodic stress initiates and promotes these sharp corners, expanding the microcracks into larger macroscopic cracks. Compared with static pressure, the growth of these microcracks results in more complete fracture of the plaque at lower inflation pressures. Higher frequencies of pressure cycling and higher pressure differences between cycles enhance the effectiveness of this crack growth mechanism. By generating controlled high-frequency pressure cycles in an angioplasty balloon, DBA reduces the balloon pressure required to rupture the calcified plaque (e.g., by 1% to 50%, such as 20% to 30% compared to a suitable non-DBA control group in some cases), improves stent deployment, improves and controls the drug delivery of a drug-coated balloon, stress softens the soft lipid core plaque, dilates calcified in-stent restenosis, breaks up the calcium deposits on the leaflets of diseased heart valves, and improves the dilation and deployment of balloon-based prostheses and devices. More details regarding embodiments of DBA methods in which the systems described herein are employed can be found in U.S. Patent No. 11464949, U.S. Published Patent Application Publication No. 20200046949, and pending PCT Application Serial No. PCT / US2020 / 055458 and pending PCT Application Serial No. PCT / US2022 / 014785; their disclosures are incorporated herein by reference.

[0210] In some cases, for example, the system of the present invention as described above is used in a sufficient manner to achieve a four-part pulse treatment plan (such as as Figure 6 shown), which provides safe and controllable dilation of the CP and the surrounding healthy soft tissue. To treat these multi-component blood vessels, a four-part treatment algorithm can be employed, which includes the following steps: (1) a soft tissue low-stress dilation phase 680 through the Mullins effect; (2) a plastic deformation phase 670 in the calcified plaque until the plaque fractures; (3) a plaque rupture detection and immediate pressure reduction phase 660 to relieve the stress on the surrounding tissue; and (4) a soft tissue low-stress dilation phase 635 through the Mullins effect to dilate the soft tissue after the calcified fracture. Figure 6An embodiment of the force applied to a blood vessel over time by this four-part algorithm is shown. Due to significant attenuation on the catheter and lack of pressure control in prior art methods, the pressure input into the catheter cannot be successfully transmitted to the balloon (system output). Thus, during high-frequency oscillations, the tissue stress in prior art systems does not return to a low state (i.e., there is no tissue relaxation period), which limits the effectiveness of the Mullins stress cycle. By minimizing attenuation and controlling pressure, embodiments of the present system cause pressure oscillations in the distal balloon (system output) that follow the pressure input from a proximal source having a pressure oscillation from 0 to 50 ATM, a frequency from 0 to 25 Hz, and a duty cycle from 60 to 80%. This advancement is important for two reasons: (1) it allows the tissue to relax during the decompression cycle (following the Mullins effect), and (2) it allows sufficient oscillations to be applied to the blood vessel during the limited time the artery is occluded during treatment. More details regarding methods of using embodiments of the present invention can be found in U.S. Patent No. 11464949, U.S. Published Patent Application Publication No. 20200046949, and pending PCT Application Serial No. PCT / US2020 / 055458 and pending PCT Application Serial No. PCT / US2022 / 014785; their disclosures are incorporated herein by reference.

[0211] In some cases, embodiments of the present invention can be used to evaluate the compliance of a blood vessel. Blood vessels are naturally compliant elastic structures. Their compliance is necessary to convert the pulsatile flow from the heart into a steady flow in the capillaries. However, with age, the aging and hardening processes reduce the compliance of blood vessels and decrease the lumen area, creating flow mismatches and additional stress in the vascular system. In particular, the compliance of blood vessels decreases during and after the formation of intimal and medial calcified plaques in the vessel wall.

[0212] Improving vascular compliance is a prerequisite for more definitive treatment of sclerosis. See Dattilo R, Himmelstein SI, Cuff RF, The COMPLIANCE 360° Trial: a randomized, prospective, multicenter, pilot study comparing acute and long-term results of orbital atherectomy to balloon angioplasty for calcified femoropopliteal disease. J Invasive Cardiol. 2014;26(8):355-360. http: / / www.ncbi.nlm.nih.gov / pubmed / 25091093. To maximize the compliance of the vessel wall after calcium accumulation, angioplasty or pulsed intravascular lithotripsy treatment can be used to fragment the intimal and medial calcium rings so that the more elastic portions in the tubular vessel are exposed and released from the dessicated calcium. As described above, embodiments of the present invention can be utilized to perform pulsed intravascular lithotripsy such that calcium can be lysed (i.e., fragmentation of CP tissue as shown in Figures 5A - 5E ), and the vessel can be ultimately post-dilated, in each case by performing atherectomy surgery using an atherectomy subsystem to gain access to the lesion. In some cases, embodiments of the present invention can be used for two applications: lysing CP tissue in a single treatment and applying an ultimate post-dilation to the tissue. That is, embodiments of the present invention are also capable of first applying DBA to pulse the vessel to fragment CP tissue and subsequently using, for example, a conventional, non-compliant balloon for post-dilation to dilate the vessel.

[0213] Vascular compliance refers to a measurable quantity defined by the following relationship:

[0214]

[0215] where ΔV is the change in the volume of the blood vessel for a given change in pressure ΔP. Due to the incompressibility of the tissue, it can be converted to an area by dividing the blood vessel volume by the blood vessel length. Since the pressure-volume relationship in arteries is non-linear, compliance is typically defined at a given pressure or volume.

[0216] Since it may be challenging to simultaneously measure in vivo the change in pressure ΔP and the change in cross-sectional area or volume of the blood vessel, which are ΔA or ΔV respectively, it may be difficult to obtain the compliance of the blood vessel. As described below, the system according to the present invention solves this problem by accurately evaluating the vascular compliance in vivo.

[0217] As described above, the proximal connector of the intravascular pulsed lithotripsy subsystem can include a membrane position sensor (such as a Hall sensor) and a pressure gauge. The membrane position sensor provides data on the spatial position of the membrane at any given time, and the pressure gauge is used to measure the pressure in the liquid passage of the balloon catheter assembly and in the distal balloon. In such examples, the system can be used to evaluate the volume expansion of the balloon and / or the vascular compliance at the balloon site in real time.

[0218] As a result of measuring the diaphragm position, the volume change in the distal balloon can be evaluated in real time, and the corresponding balloon pressure can be measured. That is, the system is configured to pressurize the distal balloon while reading the pressure and volume in the intravascular pulsed lithotripsy subsystem. This volume-pressure relationship can provide a measurement of vascular compliance because, as described above, vascular compliance is the ratio of the change in vascular volume to the change in pressure. To achieve this measurement, the volume-pressure relationship of the balloon can be measured when the distal balloon is not inhibited by the surrounding blood vessels. When the balloon is located within a rigid blood vessel, the balloon requires a higher pressure to reach the same balloon volume as it has in its uninhibited baseline state. Therefore, the balloon can be used to measure the compliance of the blood vessel. By virtue of the ability to accurately record the diaphragm position (a surrogate measurement of balloon volume) and the balloon pressure, the vascular compliance can be easily measured in vivo. This compliance measurement can be used as a measure of successful treatment, with lower compliance indicating sufficient or therapeutic balloon dilation and successful treatment. In some examples, the methods employed by the system are similar to those described in U.S. Published Application Publication No. 20150080747, the disclosure of which is incorporated herein by reference, where membrane displacement is used as a measure of balloon volume.

[0219] The system and method for measuring vascular compliance according to the present invention can be configured to obtain pressure-volume measurements before, during, and after treatment. Using the data obtained during these measurements, the change in vascular compliance can be obtained to determine the treatment effect. The change in vascular compliance can also be used to adjust the treatment intensity and / or duration.

[0220] In addition, embodiments of the present invention can be used to generate pressure-volume curves (i.e., compliance curves) under various conditions during treatment. The relative compliance changes before and after treatment can be obtained. These changes can be compared between similar vascular segments to know the appropriate level of compliance change.

[0221] In addition, the method according to the present invention may further include using other available measurement techniques (such as ultrasound, cineangiography, computed tomography, intravascular ultrasound IVUS, and / or optical coherence tomography (OCT)) to obtain concomitant measurements of the arterial cross-section. In some examples, the system according to the present invention may be configured to incorporate information obtained from such measurements (i.e., sensor fusion techniques). The volume and / or area measurements obtained by such visualization techniques may be combined with the pressure and volume readings (i.e., measurements of the relative volume and / or pressure changes) according to the embodiments of the pulsed intravascular lithotripsy subsystem of the present invention to produce an absolute compliance measurement of the blood vessel with higher accuracy. Then, such an absolute compliance measurement may be used to compare treatments across the vascular bed to optimize the treatment for short-term and long-term success. In addition, an absolute measurement of the vascular compliance curve may be obtained and compared between treatment groups.

[0222] Although the systems and methods for measuring vascular compliance have been described in the context of the systems according to the present invention, such systems and methods for measuring vascular compliance may also be applied to other systems, such as systems configured to perform static balloon angioplasty, pulsed intravascular lithotripsy, cavitation-based intravascular lithotripsy, and / or externally applied lithotripsy pulses, as well as systems for performing atherectomy alone or in combination with any such treatment. For more details regarding the methods in which the systems of the present invention may be employed, including those described in U.S. Patent No. 11464949, U.S. Published Patent Application Publication Serial Number 20200046949, and pending PCT Application Serial Number PCT / US2020 / 055458 and pending PCT Application Serial Number PCT / US2022 / 014785; their disclosures are hereby incorporated herein by reference.

[0223] As described above, the methods of the embodiments of the present invention include using the embodiments of the systems of the present invention described herein to perform atherectomy, i.e., the atherectomy procedure. The methods of the embodiments of the present invention include using the embodiments of the systems of the present invention described herein to perform pulsed intravascular lithotripsy, i.e., the pulsed intravascular lithotripsy procedure. The methods of the embodiments of the present invention include using the embodiments of the systems of the present invention described herein to perform atherectomy and pulsed intravascular lithotripsy, i.e., the atherectomy procedure and the pulsed intravascular lithotripsy procedure. Embodiments of the methods of the present invention include using the atherectomy subsystem of the system according to the embodiments of the present invention to perform atherectomy, and using the pulsed intravascular lithotripsy subsystem in the system according to the examples of the present invention to perform pulsed intravascular lithotripsy.

[0224] Other embodiments of the method of the present invention include deploying a system according to an embodiment of the present invention such that the atherectomy tool of the system is adjacent to the occlusion of the diseased blood vessel, actuating the system to create a channel in the occlusion of the diseased blood vessel with the atherectomy tool, guiding a balloon of the system through the channel, and actuating the system to apply pulsed energy to the diseased blood vessel. In some cases, guiding the balloon includes guiding the balloon to an area adjacent to the channel. In other cases, guiding the balloon includes guiding the balloon to an inner area of the channel. In an embodiment, actuating the system such that the atherectomy tool creates a channel includes using the atherectomy tool to grind out a channel. In other embodiments, actuating the system such that the atherectomy tool creates a channel includes rotating or orbiting the atherectomy tool. In some cases, creating a channel includes creating a new channel (e.g., drilling) or dilating an existing channel, in each case enabling the balloon of the intravascular pulsed lithotripsy subsystem to be guided into the channel as needed to perform intravascular pulsed lithotripsy therein.

[0225] Additional details regarding methods of using embodiments of the present invention, including additional details regarding intravascular pulsed lithotripsy, dynamic balloon angioplasty (DBA), vascular compliance, etc. utilizing embodiments of the system of the present invention, are provided in U.S. Patent No. 11464949; U.S. Published Patent Application Publication No. 20200046949; U.S. Application Serial No. 17897604; Pending PCT Application Serial No. PCT / US2019 / 027139; Pending PCT Application Serial No. PCT / US2020 / 055458; U.S. Application Serial No. 63274832; U.S. Application Serial No. 17827169; Pending PCT Application Serial No. PCT / US2002 / 014785; U.S. Application Serial No. 63238381; Pending PCT Application Serial No. PCT / US2022 / 040586; U.S. Application Serial No. 63346703; Pending PCT Application Serial No. PCT / US23 / 23533; U.S. Application Serial No. 63346704; Pending PCT Application Serial No. PCT / US23 / 22685; U.S. Application Serial No. 63444414; U.S. Application Serial No. 63545060; the respective disclosures of which are incorporated herein by reference.

[0226] Notwithstanding the appended claims, the present disclosure is also defined by the following clauses:

[0227] 1. A system, comprising:

[0228] A console;

[0229] A handle;

[0230] An atherectomy subsystem; and

[0231] Intravascular Pulse Lithotripsy Subsystem

[0232] 2. A system comprising:

[0233] A console;

[0234] A handle, wherein the handle is configured to be interchangeably and operably connected to:

[0235] An atherectomy subsystem, and

[0236] An intravascular pulse lithotripsy subsystem.

[0237] 3. The system according to clause 2, wherein the handle is operably connected to the atherectomy subsystem.

[0238] 4. The system according to clause 2, wherein the handle is operably connected to the intravascular pulse lithotripsy subsystem.

[0239] 5. The system according to any one of the preceding clauses, wherein the atherectomy subsystem and the intravascular pulse lithotripsy subsystem each include an interface configured to be operably connected to the interface of the handle.

[0240] 6. The system according to clause 5, wherein the atherectomy subsystem interface and the intravascular pulse lithotripsy subsystem interface each include an interlocking device configured to interlock with the handle interface.

[0241] 7. The system according to any one of the preceding clauses, wherein the atherectomy subsystem includes:

[0242] An atherectomy tool.

[0243] 8. The system according to clause 7, wherein the atherectomy tool includes:

[0244] A rotary atherectomy tool.

[0245] 9. The system according to any one of clauses 7 to 8, wherein the atherectomy tool includes:

[0246] An orbital atherectomy tool.

[0247] 10. The system according to any one of clauses 7 to 9, wherein the atherectomy tool includes one or more of the following:

[0248] A laser tool, an ultrasonic tool, an electrohydraulic lithotripsy (EHL) cavitation emitter tool, or a mechanical conduction tool.

[0249] 11. The system according to any one of clauses 7 to 10, wherein the atherectomy tool is configured to grind within a lesion.

[0250] 12. The system according to any one of clauses 7 to 11, wherein the atherectomy tool is located in the distal region of the system.

[0251] 13. The system according to any one of clauses 7 to 12, wherein the atherectomy tool is configured to pass through the lesion.

[0252] 14. The system according to any one of clauses 7 to 13, wherein the atherectomy tool is configured to pass through an occlusive lesion.

[0253] 15. The system according to any one of clauses 7 to 14, wherein the atherectomy tool is configured to pass through a chronic total occlusion (CTO).

[0254] 16. The system according to any one of clauses 7 to 15, wherein the atherectomy tool is configured to create a new channel within the occlusion.

[0255] 17. The system according to any one of clauses 7 to 16, wherein the atherectomy tool is configured to drill in the occlusion.

[0256] 18. The system according to any one of clauses 7 to 17, wherein the atherectomy tool is a grinding head.

[0257] 19. The system according to clause 18, wherein the grinding head is a grinding bit.

[0258] 20. The system according to any one of the foregoing clauses, wherein the atherectomy subsystem comprises:

[0259] A rotating assembly configured to generate rotational energy.

[0260] 21. The system according to clause 20, wherein the rotating assembly is operably connected to the console.

[0261] 22. The system according to any one of clauses 20 to 21, wherein the rotating assembly is configured to convert the energy transmitted from the console into rotational energy.

[0262] 23. The system according to any one of clauses 20 to 22, wherein the rotating assembly is operably connected to the potential energy source of the console.

[0263] 24. The system according to any one of clauses 20 to 23, wherein the rotating assembly is a motor.

[0264] 25. The system according to any one of the foregoing clauses, wherein the system is configured to rotate the atherectomy tool.

[0265] 26. The system according to any one of the foregoing clauses, wherein the system is configured to move the atherectomy tool in an orbital motion.

[0266] 27. The system according to any one of the preceding clauses, wherein the system is configured to rotate and orbit atherectomy tool simultaneously.

[0267] 28. The system according to any one of the preceding clauses, wherein the atherectomy subsystem comprises:

[0268] A lateral transmission assembly configured to propagate rotational energy from the rotation assembly to the atherectomy tool.

[0269] 29. The system according to clause 28, wherein the lateral transmission assembly is positioned at the distal end of the rotation assembly and the proximal end of the atherectomy tool.

[0270] 30. The system according to any one of clauses 28 to 29, wherein the lateral transmission assembly comprises a rotary drive shaft.

[0271] 31. The system according to clause 30, wherein the rotary drive shaft is a flexible drive shaft.

[0272] 32. The system according to any one of clauses 28 to 31, wherein the lateral transmission assembly is configured to accommodate a guide wire.

[0273] 33. The system according to any one of clauses 28 to 32, wherein the lateral transmission assembly comprises a guide wire lumen.

[0274] 34. The system according to any one of clauses 28 to 33, wherein the lateral transmission assembly comprises a guide wire.

[0275] 35. The system according to any one of clauses 28 to 34, wherein the lateral transmission assembly comprises a fluid bearing.

[0276] 36. The system according to clause 35, wherein the fluid bearing is configured to dissipate heat.

[0277] 37. The system according to any one of clauses 35 to 36, wherein the fluid bearing comprises a fluid present in the guide wire lumen.

[0278] 38. The system according to clause 34, wherein the guide wire is configured to provide stability to the lateral transmission assembly while propagating rotational energy from the rotation assembly to the atherectomy tool.

[0279] 39. The system according to any one of the preceding clauses, wherein the atherectomy subsystem comprises an atherectomy tool configured to drill through a lesion using mechanical conduction of a guide wire.

[0280] 40. The system according to any one of the preceding clauses, wherein the atherectomy subsystem comprises:

[0281] A pusher configured to advance and retract an atherectomy tool in distal and proximal directions.

[0282] 41. The system according to clause 40, wherein the pusher is configured to pulse-advance the atherectomy tool into and out of the lesion.

[0283] 42. The system according to any one of the preceding clauses, wherein the atherectomy subsystem comprises:

[0284] A filter located distally of the atherectomy tool.

[0285] 43. The system according to clause 42, wherein the filter is configured to protect the vasculature from distal embolization.

[0286] 44. The system according to any one of the preceding clauses, wherein the atherectomy subsystem comprises:

[0287] A sensor.

[0288] 45. The system according to clause 44, wherein the sensor is configured to sense one or more of the following: current, rotational position, speed, acceleration, temperature, linear position, torque, pressure, or flow.

[0289] 46. The system according to any one of clauses 44 to 45, wherein the sensor is configured to sense a current associated with the connection of the atherectomy subsystem and the lesion through an interface.

[0290] 47. The system according to any one of clauses 44 to 46, wherein the sensor is configured to sense a current in response to the atherectomy subsystem penetrating the lesion.

[0291] 48. The system according to any one of the preceding clauses, wherein the lesion comprises a calcified plaque.

[0292] 49. The system according to any one of the preceding clauses, wherein the intravascular pulsed lithotripsy subsystem comprises a balloon catheter assembly.

[0293] 50. The system according to clause 49, wherein the balloon catheter assembly comprises:

[0294] (a) A proximal connector operably connecting the balloon catheter assembly to the handle and configured to convert a first pulsed energy generated by a pulse generator into a second pulsed energy;

[0295] (b) A distal balloon; and

[0296] (c) A catheter member including a fluid passageway operably positioned between the proximal connector and the distal balloon and configured to propagate the second pulsed energy along the fluid passageway from the proximal connector to the distal balloon.

[0297] 51. The system according to any one of the preceding clauses, wherein the intravascular pulsed lithotripsy subsystem comprises:

[0298] a proximal connector;

[0299] a distal balloon; and

[0300] a catheter,

[0301] wherein the distal balloon is operably connected to the catheter, and the catheter is operably connected to the proximal connector.

[0302] 52. The system according to any one of clauses 50 to 51, wherein the proximal connector is configured to be operably connected to a handle.

[0303] 53. The system according to any one of clauses 50 to 52, wherein the proximal connector and the connector of the atherectomy subsystem each comprise the same handle interface.

[0304] 54. The system according to any one of clauses 50 to 53, wherein the atherectomy subsystem and the intravascular pulsed lithotripsy subsystem are integrated together.

[0305] 55. The system according to any one of the preceding clauses, further comprising an integrated atherectomy and intravascular pulsed lithotripsy subsystem, which comprises:

[0306] an atherectomy subsystem, and

[0307] an intravascular pulsed lithotripsy subsystem.

[0308] 56. The system according to any one of the preceding clauses, wherein the system is an integrated atherectomy and intravascular pulsed lithotripsy system.

[0309] 57. The system according to any one of the preceding clauses, wherein the atherectomy subsystem and the intravascular pulsed lithotripsy subsystem comprise an integrated tool.

[0310] 58. The system according to any one of the preceding clauses, wherein the atherectomy subsystem and the intravascular pulsed lithotripsy subsystem comprise a common distal region.

[0311] 59. The system according to any one of the preceding clauses,

[0312] wherein the intravascular pulsed lithotripsy subsystem comprises a guide wire lumen, the atherectomy subsystem comprises a lateral transfer assembly, the lateral transfer assembly comprises a guide wire, and the guide wire is present within the guide wire lumen.

[0313] 60. The system according to clause 59, wherein the atherectomy tool is located in the distal region of the guide wire.

[0314] 61. The system according to any one of the preceding clauses,

[0315] wherein the atherectomy subsystem includes a guide wire, and

[0316] wherein the intravascular pulsed lithotripsy subsystem includes a guide wire.

[0317] 62. The system according to any one of the preceding clauses, wherein the system is an over-the-wire (OTW) system.

[0318] 63. The system according to clause 62, wherein the guide wire is present along most of the length of the atherectomy subsystem and the intravascular pulsed lithotripsy subsystem.

[0319] 64. The system according to any one of the preceding clauses, wherein the system is a rapid exchange (RX) system.

[0320] 65. The system according to clause 64, wherein the guide wire is present only in the distal regions of the atherectomy subsystem and the intravascular pulsed lithotripsy subsystem.

[0321] 66. The system according to any one of the preceding clauses, wherein the system includes a guide wire, and the distal region of the guide wire is coated with an abrasive material.

[0322] 67. The system according to clause 66, wherein the abrasive material coating constitutes an atherectomy tool.

[0323] 68. The system according to any one of clauses 66 to 67, wherein the abrasive material coating constitutes a distal grinding head.

[0324] 69. The system according to any one of clauses 66 to 68, wherein the abrasive material coating has a predetermined diameter selected based on the treatment effect.

[0325] 70. The system according to any one of clauses 66 to 69, wherein the abrasive material coating has a predetermined diameter selected based on the distal balloon diameter of the intravascular pulsed lithotripsy subsystem.

[0326] 71. The system according to clause 70, wherein the predetermined diameter is selected such that the distal balloon of the intravascular pulsed lithotripsy subsystem can be inserted into the hole created by the abrasive material.

[0327] 72. The system according to any one of the preceding clauses, wherein the intravascular pulsed lithotripsy subsystem includes a guide wire lumen.

[0328] 73. The system according to clause 72, wherein the guide wire is present within the guide wire lumen of the intravascular pulsed lithotripsy subsystem.

[0329] 74. The system according to any one of the preceding clauses, further comprising:

[0330] A filter present on a guide wire, located distally of the atherectomy tool.

[0331] 75. The system according to clause 74, wherein the filter is configured to protect the vasculature from distal embolization.

[0332] 76. The system according to any one of the preceding clauses, wherein the atherectomy subsystem and the intravascular pulsed lithotripsy subsystem have separate distal regions.

[0333] 77. The system according to any one of the preceding clauses, wherein the catheter component of the intravascular pulsed lithotripsy subsystem is separate from the atherectomy subsystem.

[0334] 78. The system according to any one of clauses 76 to 77, wherein the separate distal regions of the atherectomy subsystem and the intravascular pulsed lithotripsy subsystem are configured to be connected to the guide wire through an interface.

[0335] 79. The system according to any one of the preceding clauses, further comprising:

[0336] A console operably connected to a potential energy source, which is operably connected to a handle assembly.

[0337] 80. The system according to any one of the preceding clauses, further comprising a controller configured to receive an input from a source external to the system.

[0338] 81. The system according to any one of the preceding clauses, further comprising a controller configured to receive an input from at least one of the following: electrocardiogram, intravascular pressure monitor, blood volume monitor, or results of an imaging system.

[0339] 82. The system according to any one of clauses 79 to 81, wherein the console is a first console and the system includes a plurality of operably connected consoles.

[0340] 83. The system according to any one of clauses 79 to 82, wherein the console comprises:

[0341] A pulse generator.

[0342] 84. The system according to clause 83, wherein the pulse generator is configured to generate pneumatic pulse energy.

[0343] 85. The system according to any one of clauses 83 to 84, wherein the pulse generator is configured to generate a pressure pulse having an amplitude selected based on a treatment effect.

[0344] 86. The system according to any one of clauses 83 to 85, wherein the pulse generator is configured to generate static pneumatic energy.

[0345] 87. The system according to any one of the foregoing clauses further includes:

[0346] Potential energy source.

[0347] 88. The system according to clause 87, wherein the potential energy source is a voltage potential or an electromagnetic potential or a pressure potential.

[0348] 89. The system according to any one of clauses 79 to 88, wherein the console includes a regulator configured to regulate a first energy from the potential energy source into a second energy.

[0349] 90. The system according to clause 89, wherein the regulator is an active regulator configured to be controlled by an electrical signal.

[0350] 91. The system according to any one of clauses 89 to 90, wherein the regulator is a passive regulator configured to be preset to a specific output.

[0351] 92. The system according to any one of the foregoing clauses, wherein the system includes:

[0352] A controller configured to control the console.

[0353] 93. The system according to clause 92, wherein the console includes the controller.

[0354] 94. The system according to any one of clauses 92 to 93, wherein the controller is configured to:

[0355] Receive an input from at least one of the console, the handle, the atherectomy subsystem, or the pulsed intravascular lithotripsy subsystem, and

[0356] At least partially based on the received input, adjust the configuration of at least one of the console, the handle, the atherectomy subsystem, or the pulsed intravascular lithotripsy subsystem.

[0357] 95. The system according to any one of clauses 92 to 94, wherein the controller is configured to receive an input from an external source of the system.

[0358] 96. The system according to any one of clauses 92 to 95, wherein the controller is configured to receive an input from at least one of the following: an electrocardiogram, an intravascular pressure monitor, a blood volume monitor, or the result of an imaging system.

[0359] 97. The system according to any one of clauses 92 to 96, wherein the console is a first console and the system includes a plurality of operably connected consoles.

[0360] 98. The system according to clause 97, wherein the plurality of consoles are operably connected to a switch.

[0361] The system according to any one of the preceding clauses further comprises:

[0362] A switch.

[0363] The system according to clause 99, wherein the switch is operably connected to the output of the potential energy source.

[0364] The system according to any one of clauses 99 to 100, wherein the switch is configured to controllably transfer the energy received from the potential energy source to one or more outputs.

[0365] The system according to any one of clauses 99 to 101, wherein the switch is configured to output an oscillating energy amplitude.

[0366] The system according to any one of clauses 99 to 102, wherein the switch is configured to output an oscillating output pressure.

[0367] The system according to any one of clauses 99 to 103, wherein the switch is an oscillator.

[0368] The system according to any one of clauses 99 to 104, wherein the switch is configured to output a static energy amplitude.

[0369] The system according to any one of clauses 99 to 105, wherein the switch is configured to output a static output pressure.

[0370] The system according to any one of clauses 104 to 106, wherein the oscillator is configured such that the oscillation frequency of the oscillator is synchronized with the electrocardiogram result.

[0371] The system according to any one of clauses 99 to 107, wherein the switch comprises a mechanical switch or an electrical switch.

[0372] The system according to any one of clauses 99 to 108, wherein the switch comprises a solenoid.

[0373] The system according to any one of the preceding clauses is further configured to detect the system state.

[0374] The system according to any one of the preceding clauses, wherein the handle is operably connected to the console.

[0375] The system according to any one of the preceding clauses, wherein the handle is configured to be operably connected to each of the atherectomy subsystem and the intravascular pulsed lithotripsy subsystem.

[0376] 113. The system according to any one of the preceding clauses, wherein the handle is configured to be operatively connected to (a) a first connector of the atherectomy subsystem and (b) a second connector of the intravascular pulsed lithotripsy subsystem.

[0377] 114. The system according to any one of the preceding clauses, wherein the handle is configured to be releasably connected to each of the atherectomy subsystem and the intravascular pulsed lithotripsy subsystem.

[0378] 115. The system according to any one of the preceding clauses, wherein the handle is operatively connected to the atherectomy subsystem and the intravascular pulsed lithotripsy subsystem.

[0379] 116. The system according to any one of the preceding clauses, wherein the handle includes an interlocking device configured to interlock with each of the atherectomy subsystem and the intravascular pulsed lithotripsy subsystem.

[0380] 117. The system according to any one of the preceding clauses, wherein the handle includes:

[0381] A single unit that houses a switch configured to transmit energy to the subsystems connected to the handle.

[0382] 118. The system according to any one of the preceding clauses, further comprising:

[0383] A rotary assembly configured to generate rotational energy for the atherectomy subsystem.

[0384] 119. The system according to any one of the preceding clauses, wherein the handle is configured to be held by an operator.

[0385] 120. The system according to any one of the preceding clauses, wherein the handle is configured to be held by an operator during use.

[0386] 121. The system according to any one of the preceding clauses, wherein the weight of the handle is from 0.5 pounds (lbs) to 2.5 pounds.

[0387] 122. The system according to any one of the preceding clauses, wherein the circumference of the handle is from 1.5 inches (in) to 5.0 inches.

[0388] 123. The system according to any one of the preceding clauses, wherein the length of the handle is from 4.0 inches to 8.0 inches.

[0389] 124. The system according to any one of the preceding clauses, wherein the handle includes one or more tactile features.

[0390] 125. The system according to clause 124, wherein the tactile features include grooves or indentations.

[0391] 126. A system, comprising:

[0392] A console;

[0393] A handle; and

[0394] An integrated atherectomy and intravascular pulsed lithotripsy subsystem, comprising:

[0395] An atherectomy subsystem; and

[0396] An intravascular pulsed lithotripsy subsystem.

[0397] 127. A console according to any one of the preceding clauses.

[0398] 128. A handle according to any one of the preceding clauses.

[0399] 129. An atherectomy subsystem of the system according to any one of clauses 1 to 126.

[0400] 130. An intravascular pulsed lithotripsy subsystem of the system according to any one of clauses 1 to 126.

[0401] 131. A method of performing intravascular pulsed lithotripsy using the system according to any one of clauses 1 to 126.

[0402] 132. A method of performing atherectomy using the system according to any one of clauses 1 to 126.

[0403] 133. A method of performing atherectomy and intravascular pulsed lithotripsy using the system according to any one of clauses 1 to 126.

[0404] 134. A method, comprising:

[0405] Performing an atherectomy procedure using the atherectomy subsystem of the system according to any one of clauses 1 to 126; and

[0406] Performing intravascular pulsed lithotripsy using the intravascular pulsed lithotripsy subsystem of the system.

[0407] 135. A method, comprising:

[0408] Introducing a combined tool of the atherectomy subsystem and the intravascular pulsed lithotripsy subsystem of the system according to any one of clauses 1 to 126 into the luminal tissue;

[0409] Performing an atherectomy procedure using the atherectomy subsystem; and

[0410] Performing an intravascular pulsed lithotripsy procedure using the intravascular pulsed lithotripsy subsystem.

[0411] 136. A method, comprising:

[0412] Introducing a guide wire into the luminal tissue;

[0413] Using the guide wire to introduce a plaque removal tool of the plaque removal subsystem of the system according to any one of clauses 1 to 126 into the luminal tissue;

[0414] Removing the plaque removal subsystem from the luminal tissue; and

[0415] Using the guide wire to introduce the distal balloon of the intravascular pulsed lithotripsy subsystem of the system into the luminal tissue.

[0416] 137. A method for treating a diseased blood vessel, the method comprising:

[0417] Deploying the system according to any one of clauses 1 to 126 such that the plaque removal tool of the system is adjacent to the occlusion of the diseased blood vessel;

[0418] Actuating the system such that the plaque removal tool creates a channel in the occlusion of the diseased blood vessel;

[0419] Guiding the balloon of the system through the channel; and

[0420] Actuating the system to apply pulsed energy to the diseased blood vessel.

[0421] 138. The method according to clause 137, wherein guiding the balloon comprises guiding the balloon to an adjacent region of the channel.

[0422] 139. The method according to any one of clauses 137 to 138, wherein guiding the balloon comprises guiding the balloon to an inner region of the channel.

[0423] 140. The method according to any one of clauses 137 to 139, wherein actuating the system such that the plaque removal tool creates a channel comprises using the plaque removal tool to grind out the channel.

[0424] 141. The method according to any one of clauses 137 to 140, wherein actuating the system such that the plaque removal tool creates a channel comprises rotating or orbiting the plaque removal tool.

[0425] 142. A kit comprising one or more components of the system according to any one of clauses 1 to 126.

[0426] 143. The kit according to clause 142, further comprising a package for the one or more components.

[0427] 144. The kit according to any one of clauses 142 to 143, wherein one or more components of the kit are reusable.

[0428] A kit according to any one of clauses 142 to 144, wherein one or more components of the kit are sterile.

[0429] It should be understood that the present invention is not limited to the specific embodiments described, and of course these embodiments can vary. It should also be understood that the terms used herein are for the purpose of describing specific embodiments only and are not intended to be limiting, since the scope of the present invention is limited only by the appended claims.

[0430] In at least some of the described embodiments, one or more elements used in an embodiment can be interchangeably used in another embodiment, unless such substitution is technically infeasible. Those skilled in the art should understand that various other omissions, additions, and modifications can be made to the above methods and structures without departing from the scope of the claimed subject matter. All such modifications and changes are intended to fall within the scope of the subject matter as defined by the appended claims.

[0431] Where a numerical range is provided, it should be understood that, unless the context clearly dictates otherwise, intermediate values between the upper and lower limits of the range, to one-tenth of the unit of the lower limit, and any other well-known or intermediate values within the said range are encompassed within the present invention. The upper and lower limits of these smaller ranges can be independently included in the smaller ranges and are also encompassed within the present invention, subject to any explicit exclusionary bounds within the said range. Where the said range includes one or both of the limits, ranges excluding either or both of the included limits are also included in the present invention.

[0432] Certain ranges are presented herein with numerical values preceded by the term "about". The term "about" is used herein to provide literal support for the exact numerical values that follow it, as well as numbers that are close to or near the numerical values that follow it. When determining whether a number is close to or approximate to a specifically recited number, an unrecited number that is close to or approximate to the specifically recited number can be a number that provides substantially the same functionality as the specifically recited number in the context in which the number is given.

[0433] As will be understood by those skilled in the art, for any and all purposes, such as in terms of providing a written specification, all ranges disclosed herein also cover any and all possible sub-ranges and combinations of sub-ranges thereof. Any listed range can be easily regarded as fully describing and enabling the same range to be broken down into at least halves, thirds, quarters, fifths, tenths, etc. that are equal to each other. As a non-limiting example, each range discussed herein can be easily broken down into a lower third, a middle third, an upper third, etc. Those skilled in the art will understand that all language such as "up to", "at least", "greater than", "less than", etc. includes the recited numbers and refers to ranges that can subsequently be broken down into sub-ranges as described above. Finally, those skilled in the art will understand that a range includes each individual member. Thus, for example, a group having 1 - 3 items refers to a group having 1, 2, or 3 items. Similarly, a group having 1 - 5 items refers to a group having 1, 2, 3, 4, or 5 items, and so on.

[0434] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, representative illustrative methods and materials are now described.

[0435] All publications and patents cited in this specification are incorporated herein by reference as if each individual publication or patent were specifically and individually indicated to be incorporated by reference and incorporated herein by reference, including but not limited to the methods and / or materials disclosed and described in the cited published texts. The citation of any publication is for its disclosure prior to the filing date and should not be construed as an admission that the present invention is not entitled to antedate such publication by virtue of a prior invention. In addition, the provided publication dates may differ from the actual publication dates, which may require separate confirmation.

[0436] It should be noted that, as used herein and in the appended claims, unless the context clearly dictates otherwise, the singular forms "a", "an", and "the" include plural referents. It should also be noted that the claims can be drafted to exclude any optional elements. For this reason, this specification is intended to serve as a basis for the use of exclusive terms such as "solely", "only", etc. in relation to the recitation of claim elements or the use of "negative" limitations.

[0437] Those skilled in the art will appreciate, upon reading this disclosure, that each of the various embodiments described and illustrated herein has discrete components and features that can be readily separated from or combined with the features of any one of several other embodiments without departing from the scope or spirit of the invention. Any recited method may be performed in the order of recited events or in any other order that is logically possible.

[0438] Those skilled in the art will understand that, generally speaking, the terms used herein, particularly the terms used in the appended claims (e.g., the subject matter of the appended claims), are generally intended to be "open" terms (e.g., the term "including" should be interpreted as "including but not limited to", the term "having" should be interpreted as "having at least", the term "includes" should be interpreted as "including but not limited to", etc.). Those skilled in the art will also understand that if the intention is to introduce a specific number in a claim statement, such intention will be explicitly stated in the claim, and in the absence of such a statement, there is no such intention. For example, for the sake of understanding, the following appended claims may include the use of the introductory phrases "at least one" and "one or more" to introduce the recitation of the claims. However, the use of these phrases should not be construed as implying that the recitation of a claim is limited to only including one embodiment of such recited claim by introducing the indefinite article "a / an", even when the same claim includes an introductory phrase such as "one or more" or "at least one" and an indefinite article such as "a / an" (e.g., "a" and / or "an" should generally be interpreted as meaning "at least one" or "one or more"); the same applies to the use of the definite article used to introduce the recitation of a claim. In addition, even if a specific number introduced by a claim reference is explicitly recited, those skilled in the art will recognize that such reference should be interpreted as meaning at least the recited number (e.g., a simple reference to "two recitations" without other modifiers means at least two recitations, or two or more recitations). In addition, in the case of using a convention similar to "at least one of A, B, and C, etc.", generally, those skilled in the art will use such a structure in the sense of understanding the convention (e.g., "a system having at least one of A, B, and C" will include but not be limited to having A alone, having B alone, having C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). In the case of using a convention similar to "at least one of A, B, or C, etc.", generally, those skilled in the art will use such a structure in the sense of understanding the convention (e.g., "a system having at least one of A, B, or C" will include but not be limited to having A alone, having B alone, having C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). Those skilled in the art will also understand that, whether in the specification, the claims, or the drawings, in fact, any disjunctive word and / or phrase presenting two or more alternative terms should be understood as contemplating the possibility of including one of the terms, any one of the terms, or both terms. For example, the phrase "A or B" will be understood as including the possibilities of "A" or "B" or "A and B".

[0439] In addition, where features or aspects of the present disclosure are described in terms of a Markush group, those skilled in the art will recognize that the present disclosure is also thereby described in terms of any individual member or subgroup of members of the Markush group.

[0440] Although the foregoing invention has been described in some detail for purposes of clarity of understanding by way of illustration and example, it will be apparent to those of ordinary skill in the art that certain changes and modifications may be made thereto without departing from the spirit or scope of the appended claims.

[0441] Accordingly, the present disclosure merely illustrates the principles of the invention. It is to be understood that those skilled in the art will be able to devise various arrangements which, although not explicitly described or shown herein, embody the principles of the invention and are included within the spirit and scope of the invention. In addition, all of the examples and conditional language recited herein are principally intended to aid the reader in understanding the principles of the invention and the concepts contributed by the inventor to further the art, and are to be construed as not being limited to such specifically recited examples and conditions. Moreover, all statements herein reciting principles, aspects, and embodiments of the invention and specific examples thereof are intended to cover both structural and functional equivalents thereof. In addition, such equivalents are intended to include both currently known equivalents and equivalents developed in the future, i.e., any elements developed to perform the same function regardless of structure. Further, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.

[0442] Although systems, devices, methods, and kits may have been or will be described for purposes of functional interpretive grammatical fluency, it should be clearly understood that unless expressly recited under 35 U.S.C. § 112, the claims should not be construed as necessarily limited in any way by the limitations of "means" or "step" limitations, but rather should be construed in accordance with the judicial doctrine of equivalents, consistent with the meaning and full scope of the definition provided by the claims, and if the claims are expressly recited under 35 U.S.C. 112, they should be accorded full statutory equivalents under 35 U.S.C. 112.

Claims

1. A system, comprising: Console; as well as A handle, wherein the handle is configured to be interchangeably operably connected to: Atherectomy subsystem, and Pulse Intravascular Lithotripsy Subsystem.

2. The system according to claim 1, wherein: The handle is operably connected to the atherectomy subsystem.

3. The system according to claim 1, wherein: The handle is operably connected to the pulsatile intravascular lithotripsy subsystem.

4. A system according to any one of the preceding claims, wherein: The atherectomy subsystem and the pulsatile intravascular lithotripsy subsystem each include an interface configured to be operably connected to an interface of the handle.

5. A system according to any one of the preceding claims, wherein: The atherectomy subsystem includes: An atherectomy tool, which is a rotary atherectomy tool or an orbital atherectomy tool or a laser tool or an ultrasound tool or an electrohydraulic lithotripsy (EHL) cavitation emitter tool or a mechanotransduction tool.

6. A system according to any one of the preceding claims, wherein: The atherectomy subsystem includes: A rotation assembly is configured to convert energy transmitted from the console into rotational energy.

7. A system according to any one of the preceding claims, wherein: The atherectomy subsystem includes: A lateral transmission assembly is configured to transmit rotational energy from the rotational assembly to the atherectomy tool.

8. A system according to any one of the preceding claims, wherein: The atherectomy subsystem includes: A sensor configured to sense one or more of: current, rotational position, velocity, acceleration, temperature, linear position, torque, pressure, or flow.

9. A system according to any one of the preceding claims, wherein: The pulsed intravascular lithotripsy subsystem includes: a proximal connector configured to be operably connected to the handle; distal balloon; and catheter, Wherein, the distal balloon is operably connected to the catheter, and the catheter is operably connected to the proximal connector.

10. The system according to claim 9, wherein: The proximal connector and the connector of the atherectomy subsystem each include an identical handle interface.

11. The system of any of the preceding claims, further comprising an integrated atherectomy and pulsatile intravascular lithotripsy subsystem, the integrated atherectomy and pulsatile intravascular lithotripsy subsystem comprising: the atherectomy subsystem, and The pulsed intravascular lithotripsy subsystem.

12. A system according to any one of the preceding claims, in, The pulsatile intravascular lithotripsy subsystem includes a guidewire lumen, the atherectomy subsystem includes a lateral transmission assembly, the lateral transmission assembly includes a guidewire, and the guidewire is present in the guidewire lumen.

13. The system according to claim 12, wherein: The atherectomy tool is present at the distal region of the guidewire.

14. A method for treating a diseased blood vessel, the method comprising: deploying the system according to any one of claims 1 to 13 such that an atherectomy tool of the system is proximate to an occlusion of a diseased vessel; actuating the system so that the atherectomy tool creates a passage in the occlusion of the diseased vessel; directing a distal balloon of the system through the passage; as well as The system is actuated to impart pulsed energy to the diseased vessel.

15. A method comprising: introducing a guide wire into the luminal tissue; using the guidewire to introduce an atherectomy tool of the atherectomy subsystem of the system according to any one of claims 1 to 13 into luminal tissue; removing the atherectomy subsystem from the luminal tissue; as well as The guidewire is used to introduce the distal balloon of the pulsatile intravascular lithotripsy subsystem of the system into the luminal tissue.

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