Systems for atherectomy and pulsed endovascular atherectomy and methods of using the systems

Abstract

Systems configured to perform atherectomy and pulsed endovascular disruption are provided. Aspects of the systems include a console and a handle, the handle configured to be interchangeably and operably connected to the atherectomy subsystem and the pulsed endovascular disruption subsystem. System elements comprising the console and handle are also provided. The systems and assemblies are used in a variety of different applications, including combined atherectomy and pulsed endovascular disruption procedures, and in balloon angioplasty applications.

Description

[Background technology]

[0001] Ischemic heart disease, the world's leading cause of death, is caused by the buildup of atherosclerotic plaque within the human vascular system. Globally, these diseases account for 84.5% of cardiovascular deaths and 28.2% of all deaths. Ischemic heart disease develops through a mechanism called atherosclerosis, which is the accumulation of fatty and calcified material, leading to stenosis (narrowing of the arterial lumen). Atherosclerotic plaque can accumulate in both coronary and peripheral arteries. Atherosclerotic plaque buildup restricts blood flow through these arteries and can lead to serious adverse cardiovascular events, such as myocardial infarction, limb amputation, and death. In the early stages of atherosclerosis, plaques are soft and fatty; however, over time, as the disease progresses, these plaques physically harden, or calcify. Calcified plaque (CP), which forms in the innermost layer of the arterial wall, is the most frequent cause. CP results from the deposition and remodeling of calcium hydroxyapatite, a process that mimics bone formation. Blood vessels with CP have reduced vascular elasticity, which impairs vascular perfusion. Due to this reduced compliance and perfusion, the presence of CP in the vasculature increases the risk of mortality and other adverse events. Summary of the Invention [Problem to be solved by the invention]

[0002] While many patients with CP are asymptomatic, a significant number experience ischemia-related symptoms and signs and undergo endovascular or surgical repair. Endovascular methods are generally preferred over surgical procedures due to their minimal invasiveness. However, the strength of calcified plaque often poses special challenges for effective endovascular treatment. There are many common endovascular procedures used to treat CP. One such method is balloon angioplasty (BA), which involves pre-dilation of the CP lesion. During BA, a balloon is advanced to the affected lesion and inflated, dilating the plaque-compressed vessel and restoring normal blood flow. If successful, the pre-dilation step is followed by a secondary treatment, such as the application of a drug-coated balloon or stent. For pre-dilation to be successful, BA requires mechanical disruption of the CP to ensure long-term vessel patency and reestablish the elasticity of the surrounding healthy vessel. To be successful, a high-pressure, non-compliant balloon is often used. However, the strength of the CP often limits sufficient balloon expansion, leaving the CP undisrupted.

[0003] Another treatment method for disrupting the CP is cutting and scoring balloon angioplasty. Cutting balloons, which are balloons surrounded by sharp metal blades at their tips, and scoring balloons, which are balloons constrained within a metal cage, are intended to generate stress concentrations for CP disruption. During balloon pressurization, the metal blades or cages can penetrate the soft tissue or CP, potentially causing serious procedural problems. These balloons have been associated with poor outcomes, including restenosis in 20–30% of cases and serious adverse events such as vessel perforation, myocardial infarction, or death in 6% of cases.

[0004] Shock wave endovascular therapy uses a low-pressure balloon with an embedded disruptor that generates shock waves. Although clinical trials have demonstrated the short-term efficacy and safety of disruption devices, recent case reports have shown that cavitation explosions above 50 ATM can lead to dangerous arterial dissection and perforation.

[0005] Another commonly used treatment for CP is atherectomy, a technique that uses grinding, for example, to adjust or debulk the CP. However, atherectomy is technically more challenging and may grind surrounding healthy tissue in addition to the CP, potentially causing long-term vascular damage.

[0006] Other treatments combine standard treatments to overcome the limitations of CP. One such clinician-developed procedure, called Rota-Shock (McLaughlin et al., "First United States Experience with Rota-Shock: A Case Series," Cardiovascular Revascularization Medicine (2022) 40: 209-213), combines Boston Scientific's Rotablator™ rotational atherectomy system with Shockwave Medical's endovascular atherectomy platform. Using the Rotablator™ rotational atherectomy system, a small abrasive burr is used to create a channel in a narrow or completely closed blockage. Once the channel is created, Shockwave Medical's endovascular atherectomy balloon is passed through the channel and transects the lesion. The endovascular atherectomy energy is transferred to the surrounding tissue, causing radial disruption of calcium, allowing the vessel to expand. Although the Rota-Shock technique may have advantages in certain circumstances, the method is bulky, time-consuming, and requires the insertion and removal of numerous mechanical systems into the vasculature. Aspects of the present invention address these drawbacks. [Means for solving the problem]

[0007] A system for performing atherectomy and pulsed endovascular disruption is provided. Aspects of the system include a console and a handle, the handle configured to be interchangeably and operably connected to the atherectomy subsystem and the pulsed endovascular disruption subsystem. In some embodiments, the handle is operably connected to the atherectomy subsystem. In other embodiments, the handle is operably connected to the pulsed endovascular disruption subsystem. In embodiments, the atherectomy subsystem and the pulsed endovascular disruption subsystem each have an interface configured to operably connect to an interface on the handle. In some embodiments, the atherectomy subsystem includes an atherectomy tool that is a rotational atherectomy tool, an orbital atherectomy tool, an orbital atherectomy tool, a laser tool, an ultrasonic tool, an electrohydrolysis (EHL) cavitation emitter tool, or a mechanotransduction tool.

[0008] Embodiments of the systems of the present invention further 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 transmit rotational energy from the rotation assembly to the atherectomy tool. In other embodiments, the atherectomy subsystem includes sensors configured to sense one or more of electrical current, rotational position, velocity, acceleration, temperature, linear position, torque, pressure, or flow.

[0009] An embodiment of the system of the present invention includes a pulsed endovascular ablation subsystem having a proximal connector configured for operably connecting to a handle, a distal balloon, and a catheter, the distal balloon being operably connected to the catheter, and the catheter being operably connected to the proximal connector. In one such embodiment, the proximal connector and the atherectomy subsystem connector each have the same handle interface.

[0010] Embodiments of the present system further include an integrated atherectomy and pulsed endovascular disruption subsystem having an atherectomy subsystem and a pulsed endovascular disruption subsystem. In some embodiments, the pulsed endovascular disruption subsystem has a guidewire lumen, and the atherectomy subsystem has a lateral delivery assembly having a guidewire disposed within the guidewire lumen. In some such cases, an atherectomy tool is disposed on a distal region of the guidewire.

[0011] A method for treating a diseased vessel is provided, comprising: deploying a system according to an embodiment of the present invention so that an atherectomy tool of the system is adjacent to an occluded portion of the diseased vessel; activating the system so that the atherectomy tool forms a channel in the occluded portion of the diseased vessel; directing a distal balloon of the system through the channel; and activating the system to deliver pulsed energy to the diseased vessel. Another embodiment of the present invention also includes introducing a guidewire into luminal tissue, using the guidewire to introduce an atherectomy tool of an atherectomy subsystem of a system according to an embodiment of the present invention into the luminal tissue, removing the atherectomy subsystem from the luminal tissue, and using the guidewire to introduce a distal balloon of a pulsed endovascular disruption subsystem of the system into the luminal tissue. [Brief explanation of the drawings]

[0012] [Figure 1A] 1 is a schematic diagram illustrating aspects of a system according to an embodiment of the present invention. [Figure 1B] FIG. 1 is a schematic diagram illustrating aspects of an atherectomy subsystem of a system according to an embodiment of the present invention. [Figure 1C] FIG. 1 is a schematic diagram illustrating aspects of a pulsed intravascular disruption subsystem of a system according to an embodiment of the present invention. [Figure 2A] 1 is a schematic diagram illustrating aspects of another system according to an embodiment of the present invention including a composite tool. [Figure 2B] 1 is a schematic diagram illustrating aspects of an atherectomy subsystem and a pulsed endovascular subsystem comprising a composite tool according to an embodiment of the present invention. [Figure 3A] FIG. 2 illustrates a console according to an embodiment of the present invention. [Figure 3B] FIG. 10 illustrates another console according to another embodiment of the present invention. [Figure 4A] 1 is a diagram showing a handle according to an embodiment of the present invention; [Figure 4B] 10A-10C show a handle according to another embodiment of the present invention and a connector according to an embodiment of the present invention, illustrating a releasable and operable interconnection between such elements. [Figure 5A] 1 is a schematic diagram illustrating an elastic conduit (e.g., an artery) embedded with hardened material (e.g., calcified plaque) being treated by a dynamic balloon angioplasty (DBA) technique and device according to some embodiments of the present teachings. [Figure 5B] FIG. 5B is a schematic diagram showing the elastic conduit of FIG. 5A guided to the diseased site and with a pre-pressurized DBA angioplasty balloon. [Figure 5C] FIG. 5B is a schematic diagram showing the elastic conduit of FIG. 5A with a DBA angioplasty balloon cycled to low pressure. [Figure 5D] FIG. 5B is a schematic diagram showing the elastic conduit of FIG. 5A with a DBA angioplasty balloon cycled to high pressure. [Figure 5E] 5B is a schematic diagram illustrating the elastic conduit of FIG. 5A having hardened material fractured in accordance with the principles of the present teachings. [Figure 6] 1 is a diagram illustrating a pulsed treatment regimen according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0013] Disclosed herein are systems and methods for combining two procedures, atherectomy and pulsed endovascular ablation, into a single procedure. In embodiments, the system includes a console and a handle, the handle configured to be interchangeably and operably connected to an atherectomy subsystem and a pulsed endovascular ablation subsystem. In some embodiments, the handle is operably connected to the atherectomy subsystem. In other embodiments, the handle is operably connected to the pulsed endovascular ablation subsystem. Aspects of the invention further include methods of performing atherectomy followed by pulsed endovascular ablation to treat CP. The methods include operably connecting the handle to the atherectomy subsystem and activating the atherectomy subsystem to perform the atherectomy procedure, and operably connecting the handle to the pulsed endovascular ablation subsystem and activating the pulsed endovascular ablation subsystem to perform the pulsed endovascular ablation procedure. In further describing various aspects of the invention, the system and its components will first be described in more detail, followed by a method of using the system.

[0014] As described, the systems of the present invention include a console and a handle, the handle configured to be interchangeably and operably connected to the atherectomy subsystem and the pulsed endovascular disruption subsystem. Furthermore, in some embodiments, the handle is operably connected to the atherectomy subsystem, while in other embodiments, the handle is operably connected to the pulsed endovascular disruption subsystem. "Interchangeably and operably connected" means, for example, that in embodiments of the handle of the present invention, an interface is provided that is configured so that the same handle interface can be connected to either the atherectomy subsystem or the pulsed endovascular disruption subsystem. That is, in embodiments, "interchangeably and operably connected" means that the handle may first be operably connected to the atherectomy subsystem so that the system may be used to perform an atherectomy procedure, and after performing the atherectomy procedure, the handle may be detached from such subsystem and then operably connected to the pulsed endovascular disruption subsystem so that the system may be used to perform a pulsed endovascular disruption procedure. In embodiments, the handle interface may include one or more structural elements, such as shape or depth or other volumetric features, connector elements, such as an O-ring and / or a pneumatic connector including a seat for the O-ring, alignment elements, keying elements, electrical connections, etc., such that the arrangement and shape of such elements of the interface align with corresponding elements of each of the atherectomy subsystem and the pulsed endovascular subsystem. That is, in embodiments, the atherectomy subsystem and the pulsed endovascular subsystem each have an interface with alignment features or other connection features, as described above and herein, that correspond to similar features of the handle interface. The handle and each of the subsystem interfaces are arranged or otherwise configured such that when the handle is connected to either subsystem, potential energy may be transferred from the handle to the connected subsystem, as described in detail herein.

[0015] 1A-1C illustrate system 100, which illustrates a combined atherectomy and pulsed endovascular atherectomy platform with separate tools. System 100 may further be referred to as a combined atherectomy and pulsed endovascular atherectomy 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 catheter 154 or lateral transmission assembly 164 or guidewire 167 or guidewire 157 or another mechanism is within vessel wall 199, distal balloon 159 and atherectomy tool 169 are not directly connected to each other, for example, via catheter 154 or lateral transmission assembly 164 or guidewire 167 or guidewire 157 or another mechanism. The lateral transmission assembly may further be referred to as a lateral transmission element.

[0016] As described herein, the atherectomy subsystem 160 and the pulsed endovascular disruption subsystem 150 are configured such that each subsystem can be interchangeably and operably connected to the handle 111. That is, the system may be configured such that the atherectomy subsystem 160 may be connected to the handle 111 first, followed by the pulsed endovascular disruption subsystem 150. The handle 111, the atherectomy subsystem 160, and the pulsed endovascular disruption subsystem 150 are configured such that the handle and each subsystem can be operably connected, subsequently released, and then operably connected. The handle 111 has an interface, e.g., shape and / or other interlocking elements, e.g., keyed surfaces or alignment features, an electrical connector arranged such that when the handle 111 interfaces with the atherectomy subsystem 160, the handle 111 provides potential energy to the atherectomy subsystem 160, and any control or data interconnections, e.g., electrical connectors, for providing electrical potential to power circuitry, e.g., a controller, or for receiving or transmitting sensor data, etc. Similarly, the shape and / or any other interlocking elements of the handle 111 are arranged such that the handle 111 further interfaces with the pulsed intravascular ablation subsystem 150, such that the handle 111 can provide potential energy to the pulsed intravascular ablation subsystem 150 and any control or data interconnections, etc. In an embodiment, the handle 111 (and console 110) interfaces with a connector 113 of the atherectomy subsystem 160 and a proximal connector 151 of the pulsed endovascular disruption subsystem 150 such that the handle 111 may be used to supply potential energy to the tools of the atherectomy subsystem 160 and the pulsed endovascular disruption subsystem 150, respectively. The connector 113 and the connector 151 may be referred to interchangeably as amplifiers or amplifier assemblies.

[0017] 1A-1C schematically illustrate an atherectomy subsystem 160 and a pulsed intravascular disruption subsystem 150, respectively, connected to a common handle 111 and console 110, according to an embodiment of the present invention. As shown in FIG. 1A, the system 100 includes a console 110 having a potential source 121 configured to provide a potential energy output 122, which may be various, such as a predetermined output, a user-defined output, or a feedback / feedforward control output. The console 110 may also be referred to as a console assembly or a console subsystem.

[0018] The potential source 121 can be a variety of potential sources, examples of which include, but are not limited to, electromagnetic, e.g., a voltage or current potential source, or a high-pressure gas, e.g., nitrogen, carbon dioxide, compressed air, or a gas mixture. The output 122 of the potential source can be set to one potential output 122, e.g., a voltage or pressure, or another output, e.g., a current or flow rate. This output 122 can be regulated, for example, by a regulator (as described herein), between minimum and maximum levels (e.g., minimum and maximum levels of pressure, voltage, or current, etc.) that may or may not exceed the level of the input potential source 121.

[0019] In some cases, multiple potential sources may be used at the same time or at different times. For example, multiple potential sources may be used via one console, multiple consoles, and / or one handle, or multiple handles. As shown, the potential output 122 is routed to the handle 111, which includes a switch 141, such as an electronic and / or mechanical switch, solenoid, or the like. The switch 141 is located within the handle 111. The handle 111 may have multiple output connections, such as an output to a pulsed endovascular disruption subsystem 150 having a distal balloon 159 and / or an output to an atherectomy subsystem 160 having an atherectomy tool 169, or the handle 111 may have a single output connection configured to be operably connected to each of the pulsed endovascular disruption subsystem 150 and the atherectomy subsystem 160. That is, the output of the handle 111 having the switch 141 may first be operably connected to the atherectomy subsystem 160, and then, upon disconnection of the atherectomy subsystem 160, may be operably connected to the pulsed intravascular disruption subsystem 150; that is, the handle 111 is configured (e.g., shaped and / or has an interlocking portion) such that the handle 111 may be interchangeably and operably connected to each of the atherectomy subsystem 160 and the pulsed intravascular disruption subsystem 150.

[0020] The handle 111 may further be referred to as a handle assembly. The handle 111 includes a switch 141 and may be operably connected to amplifier assemblies, e.g., amplifier assemblies 113, 151, corresponding to each of the atherectomy subsystem 160 and the pulsed intravascular disruption subsystem 150, respectively. The amplifier assemblies 113, 151 may further 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 have interlocking and / or standardized shapes and interconnections) such that the handle assembly 111 can be releasably engaged with each amplifier assembly 151, 113 (i.e., operably connected so that potential energy is transferred from the handle to the amplifier assembly, and then disengaged). In some cases, the handle assembly 111 is reusable (e.g., for different patients and / or different procedures), while the atherectomy subsystem 160 including the amplifier assembly 113 and the pulsed intravascular disruption subsystem 150 including the amplifier assembly 151 are disposable.

[0021] In embodiments, the handle assembly 111 may then be detached from, for example, the amplifier assembly 113 to 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, the 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 111 and the console 110 to perform an atherectomy procedure. Thereafter, the operator may detach the handle assembly 111 from the atherectomy amplifier assembly 113 and operably connect the pulsed intravascular ablation subsystem 150 to the handle 111 and the console 110 to perform a pulsed intravascular ablation procedure. That is, although system 100 includes separate atherectomy and pulsed endovascular disruption subsystems, such subsystems each connect to a common potential source (i.e., handle 111 itself is operably connected to console 110), thereby improving operator ease of use and reducing time during combined atherectomy and pulsed endovascular disruption procedures.

[0022] As described herein, embodiments of the system of the present invention may further include a handle assembly 111, an amplifier assembly 151 configured for the pulsed intravascular disruption subsystem 150, and an amplifier assembly 113 configured for the atherectomy subsystem 160. In such embodiments, the handle assembly 111 and the amplifier assembly 113 may then be disconnected from one another to operably connect the handle assembly 111 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 the lesion 198, then disconnect the atherectomy subsystem 160 from the handle 111, and then connect the pulsed intravascular disruption amplifier 151 to the handle 111 and treat the lesion 198. These steps may be repeated as necessary during a combined atherectomy and pulsed intravascular disruption procedure.

[0023] The console 110 may also be referred to as a console assembly or a console subsystem. In some embodiments, as shown schematically in FIG. 1A , the system 100 includes a console 110, which may include one or more console units 120; a handle 111 having a switch 141; an atherectomy subsystem 160 having a connector 113, a rotation assembly 161, a lateral transmission assembly 164, and an atherectomy tool 169; and a pulsed endovascular disruption subsystem 150 having a proximal connector 151, a catheter 154 having a fluid passageway connecting a distal region and a proximal region of the catheter 154, and a distal balloon 159. The switch may also be referred to as an oscillator 141. In embodiments, the switch 141 is located within the handle 111. In an embodiment, the atherectomy subsystem 160 includes a rotation assembly 161 operably connected to a connector 113 configured to transfer potential energy from the handle 111 to the rotation assembly 161 .

[0024] The handle 111 having the generator 141 is connected to the atherectomy subsystem 160 for delivering pulsed energy (i.e., second pulse energy) or static energy to the atherectomy tool 169 via the connector 113, the rotation assembly 161, and the lateral transmission assembly 164. The atherectomy subsystem 160 is further configured to translate distally and proximally, as indicated by arrow 168. The handle 111 having the generator 141 is connected to the pulsed endovascular disruption subsystem 150 for delivering pulsed energy (i.e., second pulse energy) or static energy to the distal balloon 159 via the proximal connector 151 and the catheter 154 to pressurize the distal balloon 159.

[0025] The console assembly 110 of the system 100 includes a single console 120. The console 120 may further be referred to as a console unit. However, in embodiments of the present system, one or more console units may be provided. When multiple console units are used, such console units may be combined into a single physical element (i.e., a housing) or may be separated into multiple housings, e.g., one housing per console unit. In such cases, the console units are configured to operate independently of one another, i.e., may be independently controlled, regardless of whether the console units are in a single housing or multiple housings. In some cases, a first console unit may be used in connection with supplying potential energy to the atherectomy subsystem 160, and a second console unit may be used in connection with supplying potential energy to the pulsed intravascular disruption subsystem 150.

[0026] The console unit 120 includes a potential source 121 for generating or providing energy for transfer to the handle 111 having a switch 141 via a potential regulator 122 for modulating the transferred potential energy. In some embodiments, the potential source 121 may be separate from the console unit 120 and the console assembly 110. That is, the potential source 121 may be operably connected to the console assembly 110 but may not be housed within the same housing as the console assembly 110. The output from the potential source 121 may include regulated or unregulated potential energy 122, such as energy from high-pressure fluid or voltage or current. The potential regulator 122 may be used to modify the potential energy output from the potential source 121 into a form that can be transferred and further manipulated by the switch 141. The switch 141 may further be referred to as an oscillator. The switch 141 may generate pulsed energy from the energy transferred from the potential source 121 for output to a subsystem.

[0027] In some embodiments, multiple console units can be included in the console assembly 110 and can operate substantially in parallel (i.e., independently) to generate multiple potential outputs 122 for delivery to multiple handles, each having an oscillator, or to a single handle that is otherwise provided with multiple oscillators. In some embodiments, when providing different configurations of energy, e.g., pulsed energy, to tissue during treatment, such as treatment of cardiovascular tissue or treatment of tissue containing calcified plaque deposits, multiple console units 120 can be configured to generate multiple potential outputs 122, e.g., when the atherectomy subsystem and the pulsed endovascular ablation subsystem are configured to receive potential energy in different forms (e.g., electrical potential and high-pressure gas, respectively) and / or at different frequencies, duty cycles, and / or amplitudes. In such cases, the different potential outputs 122 can be applied to tissue, e.g., cardiovascular tissue, separately, e.g., via the atherectomy subsystem or the pulsed endovascular ablation subsystem, or at different times. That is, one potential source may be operably connected to system 100 at a first time for use in an atherectomy procedure, and then another potential source may be operably connected to system 100 at a second time for use in a pulsed intravascular disruption procedure. In other cases, potential outputs from multiple console units may be combined, for example, at a single handle. In still other cases, where treatment of tissue such as cardiovascular tissue, e.g., treatment of tissue containing calcified plaque deposits, requires the application of different forms of energy, multiple console units may be configured to generate multiple potential outputs comprising different forms of potential energy (e.g., high-pressure fluid or voltage potential energy). For example, in embodiments, an atherectomy subsystem may be provided that utilizes a rotary tool and one or more of a laser tool, an ultrasonic tool, an electrohydraulic (EHL) cavitation emitter tool, a mechanotransduction tool, or the like.

[0028] The console assembly 110 further includes controllers 130a, 130b, each configured to receive inputs, e.g., control signals and / or data input signals, e.g., sensor data signals, from at least one of the console assembly 110, the potential source 121, the handle 111, the switch 141, the atherectomy subsystem 160, the amplifier 113, the pulsed intravascular ablation subsystem 150, the proximal connector 151, or other aspects of the system 100. In the illustrated embodiment, the controller 130a receives inputs from the pulsed intravascular ablation subsystem 150. That is, the controller 130a receives input signals from sensors 152, 153 of the pulsed intravascular ablation subsystem 150 via the electrical connector 155. The sensors 152, 153 may include any sensors configured to sense any relevant detectable characteristic of the pulsed intravascular ablation subsystem 150. For example, sensor 152 may include a pressure transducer configured to measure pressure within pulsed intravascular disruption subsystem 150, such as the pressure in a fluid channel of catheter 154, or the pressure of an aspect of distal balloon 159, such as an angioplasty balloon, and sensor 153 may include a volume sensor (e.g., a displacement sensor, e.g., a Hall sensor, integrated into proximal connector 151) configured to measure the volume of fluid within or displaced into distal balloon 159. That is, in such an embodiment, movement of proximal connector 151 displaces fluid into catheter 154 and / or distal balloon 159.

[0029] Similarly, controller 130b receives input from atherectomy subsystem 160. That is, controller 130b receives input signals from sensors 162, 163 of atherectomy subsystem 160 via electrical connector 165. Sensors 162, 163 may include any convenient sensors configured to sense any relevant characteristic of atherectomy subsystem 160 that is detectable. For example, sensors 162, 163 may include sensors configured to sense rotational position, velocity, acceleration, temperature, linear position, torque, or pressure of aspects of lateral transmission assembly 164 or atherectomy tool 169, and / or may include sensors configured to sense electrical current associated with atherectomy subsystem 160 contacting or penetrating an occluded lesion 198, and / or sensors 162, 163 may be configured to sense one or more of rotational position, velocity, acceleration, temperature, linear position, torque, or pressure associated with rotational assembly 161 or atherectomy tool 169. In some cases, sensors 162, 163 may include optical or rotary encoders or other mechanisms configured to ascertain rotational movement or displacement, such as position, velocity, acceleration, or jerk, of aspects of the atherectomy subsystem.

[0030] In some cases, one or both of sensors 162 and 163 are configured to measure torque, such as the torque applied by atherectomy tool 169 to lesion 198. For example, such a torque sensor may be configured to detect how much resistance the atherectomy tool encounters as it engages lesion 198 or as it advances into lesion 198. Changes in torque measured by such a sensor may indicate how much the atherectomy tool 169 has penetrated lesion 198. For example, a sudden drop in the amount of applied torque may indicate that the atherectomy tool 169 may no longer grind against the aspects of lesion 198 (e.g., no longer grind against calcified plaque in lesion 198).

[0031] Input from sensors, such as sensors 162 and 163, may be utilized in connection with controlling aspects of system 100, such as aspects of atherectomy subsystem 160. For example, in embodiments, the acceleration and / or rotational velocity of atherectomy tool 169, as detected by one or more sensors, may be utilized in connection with establishing a control loop to control a configurable aspect of the subsystem, such as the rotational velocity of the atherectomy tool or the lateral movement (e.g., distal advancement) of the atherectomy tool. Such control may take the form of feedback or feedforward control techniques. In some cases, a PID control loop mechanism is applied based on data detected by one or more sensors, such as sensors 162 and 163. If rotating assembly 161 operates based on an electrical potential, control methods, such as the control loops described above, may be utilized in connection with controlling the voltage or current applied to rotating assembly 161. In some cases, system 100 includes a sensor configured to detect lateral movement of lateral transmission assembly 164, for example, along arrow 168. Any convenient position sensor may be applied for this purpose, such as an optical encoder. In some cases, the sensor of interest comprises a sensor configured to detect fluid pressure, for example, to sense pressure within the system 100 or to sense pressure within the blood vessel 199.

[0032] In some cases, controllers 130a, 130b may be configured to receive input from multiple sensors, including sensors (e.g., pressure sensors, temperature sensors, volume sensors, displacement sensors, etc.) configured to measure any relevant aspect of system 100 or the environment to which system 100 is applied, and may be configured to capture data from any location throughout system 100, including, for example, one or more locations of system 100, such as atherectomy tool 169, lateral transmission assembly 164, connector 113, rotation assembly 161, distal balloon 159, catheter 154, proximal connector 151, handle 111, oscillator 141, console unit 120, or console assembly 110. Controllers 130a, 130b are located within console assembly 110. However, in other embodiments, controls 130a, 130b may be located, for example, in handle 111, or in pulsed intravascular disruption subsystem 150, or in proximal connector 151, or in atherectomy subsystem 160, or in amplifier 113, or in rotation assembly 161. System embodiments may include one or more controls, e.g., 1, 2, 3, 4, 5, or more controls, and such controls may be located within the same aspect or subsystem of the system or may be distributed in different locations throughout the system.

[0033] In general, in embodiments, sensors may be configured at any desired location on system 100 to collect any desired information regarding the use of system 100, for example, in connection with a treatment procedure. In other cases, controls 130a, 130b may be configured to receive input from a user input, such as a button or switch, for specifying treatment options, such as system pressure, frequency, duty cycle, etc.

[0034] Controller 130a receives inputs from pressure transducer 152 of pulsed intravascular disruption subsystem 150 and, based at least in part on such inputs, generates control signals to control aspects of console assembly 110, such as the magnitude of potential output 122, i.e., via an active regulator used to adjust the magnitude (e.g., output pressure) of potential output 122. Similarly, controller 130b receives inputs from sensors 162 of atherectomy subsystem 160 and, based at least in part on such inputs, generates control signals to control aspects of console assembly 110, such as the magnitude of potential output 122, i.e., via an active regulator used to adjust the magnitude (e.g., output pressure) of potential output 122. In embodiments, controllers 130a, 130b may be integrated into a single controller 130, i.e., controller 130 has logically distinct (but not physically distinct) controllers 130a, 130b.

[0035] The output of the console assembly 110 is operably connected to the handle 111, which includes an oscillator 141, such that energy transmitted from the potential output 121 of the console unit 120 (i.e., the regulated potential output 122) is transmitted to the oscillator 141 of the handle 111. The oscillator 141 is configured to generate pulsed or static energy (e.g., energy whose magnitude varies over a period of time or whose magnitude does not change over a period of time) from the energy transmitted from the potential source 121 (i.e., the regulated potential output 122). In some cases, the oscillator 141 may include a solenoid valve configured to enable or block energy transmission to the pulsed intravascular disruption subsystem 150 and / or the atherectomy subsystem 160. In other cases, the oscillator 141 may include any applicable electrical switch, such as an electrical solenoid, an optical switch, or a mechanical switch, as known in the art. As described herein, the behavior of oscillator 141 may be controlled, for example, by controllers 130a, 130b, based on any desired feedback, for example, feedback from system 100, or an external signal, for example, input from an operator of system 100, e.g., a clinician.

[0036] The controls 130a, 130b are shown connected to an oscillator 141 within the handle 111. In some cases, the oscillator 141 may be configured such that aspects of the behavior of the oscillator 141, such as the oscillation frequency and / or duty cycle, may be controlled by the controls 130a, 130b. For example, the controls 130a, 130b may control the position (e.g., open or closed position) or other aspects of the behavior of the solenoid of the oscillator 141, such as the frequency or duty cycle.

[0037] FIG. 1B illustrates in more detail certain aspects of an atherectomy subsystem 160 including an amplifier 113 and a rotation assembly 161, as seen in the system 100 of FIG. 1A. Referring to FIGS. 1A and 1B, the atherectomy subsystem 160 is configured to remove or destroy an occlusion 198, such as a calcified plaque deposit or a chronic total occlusion (CTO), within a blood vessel 199. The atherectomy subsystem 160 includes a lateral transmission assembly 164 having a distal end and a proximal end, the distal end configured for insertion into the blood vessel 199. In some cases, the system of the present invention is used to address calcified plaque deposits where calcification prevents or inhibits compaction of the plaque deposits. The atherectomy subsystem 160 further includes an atherectomy tool 169 having a rotational cutting mechanism disposed at the distal end of the lateral transmission assembly 164 for severing and removing the occlusion 198 from the blood vessel 199. The atherectomy tool 169 may include, for example, a burr. The atherectomy subsystem 160 further includes an amplifier 113 and a rotation assembly 161 configured to be operably connected to the handle 111 and the potential source 121 of the console 110. The connector 113 may further be referred to as an amplifier or a proximal connector. The connector 113 physically connects to the output of the handle 111 and is configured to transfer potential energy received from the output of the handle 111 to the rotation assembly 161. In some cases, the connector 113 is simply a pass-through device configured to transfer potential energy received from the handle 111 to the rotation assembly 161. The rotation assembly 161 is configured to operably connect to the proximal end of the lateral transmission assembly 164 to provide rotational force to the atherectomy tool 169.

[0038] The atherectomy subsystem 160 has a connector 113 that connects to the handle 111. In embodiments, the connector 113 may include a pass-through device. That is, the connector 113 may be configured to allow potential energy, such as pressurized gas or electrical potential, to pass through the connector 113 and reach the rotation assembly 161. In some cases, the connector 113 is configured to allow pressurized gas to pass through the connector 113 and enter the rotation assembly 161, where the pressurized gas is used to power rotation and / or rotation and / or lateral translation of the atherectomy tool 169 via the rotation assembly 161. In other cases, the connector 113 is configured to allow electrical potential energy to pass through the connector 113 and enter the rotation assembly 161, again to power movement, such as rotation and / or rotation and / or lateral translation, of the atherectomy tool 169. In some cases, the connector 113 is used to provide an interface, such as a standard, uniform, or modular interface, between the rotation assembly 161 and the output of the handle 111. For example, the handle 111 may be configured with only one output for transmitting potential energy to a distal aspect of the system 100, and such an output of the handle 111 may be configured with, for example, shape and / or other interlocking features, such that it can be operably connected to the connector 113 and the proximal connector 151 of the pulsed intravascular disruption subsystem 150. In some cases, the handle and connector have an interface that allows for use such that the connector 113 of the atherectomy subsystem 160 is first operably connected to the output of the handle 111, then detached from the handle 111, and thereafter the proximal connector 151 of the pulsed intravascular disruption subsystem 150 is operably connected to the output of the handle 111.

[0039] Embodiments of the present invention are advantageous over conventional approaches to atherectomy and / or pulsed endovascular disruption insofar as at least each of the atherectomy subsystem 160 and pulsed endovascular disruption subsystem 150 may be operably connected to a single handle 111. That is, the use of a single handle 111 and console 120 to which each of the atherectomy subsystem 160 and pulsed endovascular disruption subsystem 150 are separately operably connected simplifies and streamlines the performance of combined atherectomy and pulsed endovascular disruption procedures.

[0040] The atherectomy subsystem 160 further includes a rotating assembly 161 operably connected to an atherectomy tool 169 having, for example, a rotary cutting mechanism via a lateral transmission element 164, and configured to control the rotational speed and / or orbital speed, direction, acceleration, etc. of the rotary cutting mechanism 169 and to collect exhaust gases.

[0041] Atherectomy subsystem 160 may further include a visualization mechanism, such as a fluoroscope-based mechanism or an ultrasound-based mechanism, connected to a control unit, e.g., an external control unit or a unit configured to visualize aspects of system 100, or to a console having a display (e.g., display 330a of console 300a in FIG. 3A ) for visualizing the distal end of lateral transmission element 164 or atherectomy tool 169 during the atherectomy procedure, i.e., for visualizing aspects of lesion 198 or vessel 199 and the position of atherectomy tool 169 relative to aspects of lesion 198 or vessel 199. Lateral transmission element 164 and / or atherectomy tool 169 may include radiopaque markers at any convenient location, e.g., at the distal region or distal end, configured to facilitate such visualization. In embodiments, an operator of the system may be able to view x-ray images while performing an atherectomy procedure using an embodiment of the system to visualize the atherectomy tool and the treatment effect on the lesion. In some cases, the operator may be provided with feedback, such as visual, audio, or tactile feedback (e.g., a vibration in the handle), to indicate a treatment characteristic, such as whether the atherectomy tool has engaged or crossed the lesion.

[0042] As described herein, the lateral transfer element 164 may comprise, for example, a catheter or a guidewire, or a combination thereof. The rotation assembly 161 may be attached to the proximal end of the lateral transfer element 164 and may be further configured to control the position and orientation of the distal end of the catheter 164 within the blood vessel, for example, to translate the atherectomy tool 169 distally to further engage the occlusion 198. The lateral transfer element 164 of the atherectomy subsystem 160 has a lumen 166 extending therethrough from a proximal region to a distal region thereof for aspirating any removed fragments of the occlusion 198 from the blood vessel 199, for example, by applying vacuum pressure to aspirate the removed fragments of the occlusion 198. 1B , views A and B show cross sections of the lateral transfer element 164 and the atherectomy tool 169 at positions A and B of the lateral transfer element 164. In views A and B, the lateral transfer element 164 of the atherectomy subsystem 160 is illustrated as a braided shaft having a lumen 166. In other embodiments, the lateral transfer element 164 need not be braided and may or may not include multiple constituent fibers. If a lumen 166 is provided, a support member, such as a guidewire, may be provided within the lumen 166 along all or part of the length of the lateral transfer assembly to provide additional support to the atherectomy tool 169. In some embodiments, the lateral transfer assembly 164 may be a solid shaft, in which case the lumen 166 is not present.

[0043] The atherectomy subsystem 160 further includes a mechanism for detecting and reporting the progress of the atherectomy procedure. Such a mechanism may include one or more pressure, torque, occlusion, or current sensors connected to the controller and may be configured to detect how far the atherectomy tool 169 has penetrated a lesion 198, such as a chronic total occlusion.

[0044] As described herein, cross-sections A and B show cross-sections of lateral transfer element 164 at the cross-sections indicated by A and B. In cross-section A, lateral transfer element 164 and lumen 166 are shown. In cross-section B, lateral transfer element 164 with lumen 166 is shown, along with a cross-section of abrasive and / or bonding material 169a extending radially outward from lateral transfer element 164 to form an atherectomy tool 169, in this case a rotating abrasive burr configured to puncture and enlarge the diameter of a lesion, such as lesion 198 in blood vessel 199.

[0045] The atherectomy subsystem 160 operates by inserting the distal end of the atherectomy subsystem 160 (i.e., the distal end of the lateral transfer element 164 and the atherectomy tool 169) into the blood vessel 199, and the atherectomy tool 169 cuts and removes occlusive material 198, such as calcified plaque, from the blood vessel 199. The removed material may be aspirated from the blood vessel 199 through the lumen 166 and expelled from the subject's body, while the progress of the atherectomy procedure may be monitored and reported by the control unit. A visualization mechanism, such as a fluoroscopy-based mechanism or an ultrasound-based mechanism, allows an operator, e.g., a clinician or physician, or other operator, to view the distal end of the lateral transfer 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 transfer element 164 or the atherectomy tool 169. For example, embodiments of the atherectomy subsystem may include radiopaque markers.

[0046] The amplifier 113 of the atherectomy subsystem 160 is releasably connected to the handle 111 having the oscillator 141 and the console 110 having the potential source 121, which provides the appropriate energy for the rotation assembly 161 to rotate the atherectomy tool 169 via the lateral transmission element 164. The connector 113 receives regulated potential energy, such as voltage or pressure, or otherwise current or flow, from the handle 111 and transmits such energy to the rotation assembly 161. In some cases, the atherectomy control unit converts the energy to rotational energy. In some cases, for example, when the handle 111 transmits potential energy in the form of pressurized gas, the amplifier 113 receives exhaust gas from the rotation assembly 161 and transmits it back to the console 110 for release to atmosphere. In some cases, the amplifier 113 connects to various sensors provided in the atherectomy control unit.

[0047] The rotation assembly 161 of the atherectomy subsystem 160 is an integral component of the overall system configuration and may be configured to allow precise control of the position and orientation of the distal end of the lateral transfer element 164, and therefore the position and orientation of the atherectomy tool 169 within the blood vessel 199 and relative to the occlusion 198. The rotation assembly 161 may be configured to allow both manual and / or automatic control of a linear stage or advancer responsible for positioning and orienting the distal end of the lateral transfer element 164 or the lateral position of the atherectomy tool 169, i.e., its position along arrow 168.

[0048] A linear stage within the rotation assembly 161 may be powered by a motor and / or air pressure and / or manual control by the operator of the system 100 to smoothly and precisely move the distal end of the lateral transfer element 164 or the atherectomy tool 169. Such a linear stage may be programmed with limits to ensure that the distal end of the lateral transfer element 164 or the atherectomy tool 169 does not extend beyond a certain range, helping to maintain the safety and effectiveness of the atherectomy procedure. Such a linear stage may have one or more sensors to detect the linear movement of the atherectomy tool 169 or one or more visual fiducials to indicate the linear movement of the atherectomy tool 169. In embodiments, the linear movement of the atherectomy tool 169 measured or indicated by the linear stage may be evaluated or compared against visualization or measurement of the appearance of the lesion 198, possibly in real time during the procedure. Such a comparison can detect whether the distance the atherectomy tool 169 is translated by the linear stage is equal to or exceeds the visualized or measured depth of the lesion 198. Such a measurement or reference distance may be used to determine whether the atherectomy tool 169 has moved across the lesion 198. In embodiments, the linear stage may be configured to move the rotating assembly 161. In some embodiments, the linear stage may be configured to drive a motor of the rotating assembly 161, which is responsible for generating rotation of the lateral transfer element 164, and is itself fixed to the lateral transfer element 164. The rotating assembly 161 may be configured to grasp or be fixed to the lateral transfer element 164, such that the linear stage moves both the rotating assembly 161 and the lateral transfer element 164 together to advance the atherectomy tool 169.If the linear stage is configured to allow manual control of lateral (i.e., longitudinal) movement of the atherectomy tool, the manual linear stage may take the form of a syringe-like structure, with the rotating assembly 161 being urged forward relative to the outer housing, for example, when a manual force is applied.

[0049] To ensure that the distal ends of the lateral transfer elements 164 or the atherectomy tool 169 are accurately positioned, various feedback sensors may be provided on the rotation assembly 161 and other aspects of the atherectomy subsystem 160. Such sensors provide real-time information regarding the position, orientation, and movement of the distal ends of the lateral transfer elements 164 or the atherectomy tool 169, allowing the control unit to make any necessary adjustments to the position and orientation of the distal ends of the lateral transfer elements 164 or the atherectomy tool 169.

[0050] The position of the atherectomy tool 169 may be guided using various parameters, such as absolute or relative changes in vascular flow or pressure, or may be guided based on the rotational characteristics, such as torque, velocity, position, and acceleration, of the lateral transmission element 164. This information can be used by the control unit to optimize the performance of the atherectomy subsystem 160 to ensure that the occlusion is removed from the vessel as effectively, efficiently, and safely as possible.

[0051] The atherectomy tool 169 is an abrasive burr having a diameter ranging from 0.1 mm to 5 mm and a length ranging from 1 mm to 50 mm. When the atherectomy tool 169 includes an abrasive burr, such abrasive burr may be eccentric or concentric with a substantially circular cross-section, as shown in cross-section B of the atherectomy tool 169 in FIG. 1B. In embodiments used to treat traversable but narrow lesions, the atherectomy tool 169 may include a burr positioned or attached 1 mm to 15 cm from the distal end of the lateral transfer element 164. In embodiments used to treat non-traversable lesions, the atherectomy tool 169 may include a burr positioned or attached 0 mm to 20 mm from the distal end of the lateral transfer element 164.

[0052] Other aspects of the atherectomy tool 169 and atherectomy subsystem 160, such as the rotation assembly 161, may be configured to rotate the atherectomy tool 169 in an orbital and / or rotational motion. In some cases, the rotation mechanism is based on the speed, direction, pulsation, i.e., pulse or acceleration, the configuration of the drive shaft, an internal mandrel or guidewire, or the position, orientation, mass, or offset of the atherectomy tool 169. As described herein, the atherectomy tool 169 may be, for example, an abrasive burr. In embodiments, the mechanism of the atherectomy subsystem 160 or atherectomy tool 169 can be controlled to optimize the cutting behavior for the atherectomy procedure. In embodiments, the combination of both rotation and orbit of the atherectomy tool provides a safeguard in that the atherectomy tool is used to destroy only diseased tissue and not healthy tissue. In such cases, the rotational and orbital speeds or other mechanical properties (e.g., orbital diameter, etc.) may be selected or otherwise configured so that the movement of the abrasive surface of the tool can engage diseased tissue, including relatively hard calcified plaque. However, if such an abrasive surface inadvertently contacts healthy tissue, such as lumen wall tissue, the abrasive surface of the atherectomy tool may be unable to engage such tissue, e.g., due to the relative elasticity of such healthy tissue, minimizing any inadvertent damage to the healthy tissue. Such a combination of rotational and orbital motion of the atherectomy tool provides advantages of embodiments of the present invention over the prior art, at least insofar as embodiments of the present invention provide such safeguards as described above with respect to preventing damage to healthy tissue, such as the vessel wall 199.

[0053] In embodiments, atherectomy tool 169 includes any abrasive material, binder, or mixture for producing an abrasive material. Abrasive materials of interest include diamond, quartz, aluminum oxide, silicon carbide, zirconia, alumina ceramic, and the like. Binder materials of interest include any vitreous or resin binder. In embodiments, the abrasive material used to form atherectomy tool 169 is present at a diameter sufficient to provide abrasive effect on calcified tissue, such as lesion 198, for example, the particular diameter of atherectomy tool 169 shown in cross-section B of FIG. 1B .

[0054] In embodiments, the lateral transfer elements 164 configured to deliver energy to the atherectomy tool 169 include a suitable braided material, such as nitinol, stainless steel, titanium, platinum, or aluminum. The lateral transfer elements of interest may be fabricated with or without a core and may include an outer and / or inner lubricious coating, such as a silicone coating or a biocompatible lubricious coating. The lateral transfer elements of interest may be unifiler (comprising one filament, e.g., a single-filament configuration) or multifilar (comprising multiple filaments, e.g., a multifilament braid). The lateral transfer elements of interest may be configured to transmit rotational energy from a relatively proximal position of the lateral transfer element to a relatively distal position of the lateral transfer element. For example, the lateral transfer elements may be configured to avoid or resist twisting or kinking as the lateral transfer element rotates. That is, the lateral transfer elements may be configured such that they do not twist, tangle, or kink when rotated. In other words, the lateral transfer elements may be configured with sufficient stiffness to be able to transfer rotational energy from a relatively proximal region of the lateral transfer element to a relatively distal region of the lateral transfer element.

[0055] The lateral transfer assemblies of interest may have any convenient length, diameter, and shape, such as, for example, an outer diameter of 0.002 inches to 0.032 inches. In some cases, the length of the lateral transfer assembly is in the range of 10 cm to 5 m, e.g., 100 cm to 300 cm. The lateral transfer assembly may also be referred to as a lateral transfer element. In embodiments where the lateral transfer element includes an internal lumen, e.g., for passage of a guidewire, the internal diameter of the lateral transfer element may be in the range of 0.003 inches to 0.087 inches. As described, the lateral transfer elements of interest, such as lateral transfer element 164, may be configured to form an eccentric or concentric atherectomy tool 169. In some cases, the atherectomy tool is formed by coating regions of the lateral transfer element 164 with an abrasive material and / or a bonding material and / or an abrasive material and / or a mixture thereof. In lateral transfer element embodiments, metal particles may be electroplated at one or more selected locations on the exterior of the lateral transfer element 164, for example, at or around the distal region of the lateral transfer element 164.

[0056] As described herein, the atherectomy subsystem 160 includes an atherectomy tool 169. The atherectomy tool 169 may be any convenient tool for use in preparing or creating a hole in the lesion 198 so that the pulsed endovascular disruption subsystem 150 can be used to create a crack in the lesion 198, for example, along the length of the lesion 198. That is, the atherectomy tool 169 may be any convenient tool for modifying the lesion 198 so that the distal balloon 159 of the pulsed endovascular disruption subsystem 150 can be positioned within the lesion 198 to perform the pulsed endovascular disruption procedure.

[0057] Examples of atherectomy tools include rotational, circular, laser, ultrasonic, electrohydraulic (EHL) cavitation emitter, or mechanotransduction tools, etc. In some cases, the atherectomy subsystem 160 includes a guidewire 167 and utilizes mechanotransduction of the guidewire 167 to drill a hole through the occlusion, lesion, or chronic total occlusion 198.

[0058] Depending on the type of occlusion 198 and the type of atherectomy tool 169 used, the atherectomy tool may be configured to grind within or traverse the lesion. In some cases, the atherectomy tool is configured to create a new channel or drill a hole within the occlusion. In embodiments, the atherectomy tool 169 is a burr, such as an abrasive burr. As described, the atherectomy subsystem 160 may be used to create a channel, hole, or other space within a lesion of vascular or luminal tissue, or an occlusion, or a lesion containing other blockages, such as calcified plaque, so that the distal balloon 159 of the pulsed endovascular disruption subsystem 150 may be positioned within the new channel to further disrupt the lesion 198. That is, the atherectomy subsystem 160 may be used to create a space within the lesion into which the distal balloon 159 may fit to perform a pulsed endovascular disruption procedure and further disrupt the lesion.

[0059] Referring again to FIG. 1A , two views of the same vessel wall 199 with the same occlusion or lesion 198 are shown on the right side of FIG. 1A . This vessel wall 199 with the occlusion or lesion 198 is identical in the upper and lower views and is replicated to illustrate how the atherectomy subsystem 160 and the pulsed intravascular disruption subsystem 150 each interact with the same vessel wall 199 with the same occlusion or lesion 198. As discussed herein, the occlusion or lesion 198, for example, a 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, configured to detect an electrical change, such as current or potential, caused by the atherectomy tool 169 penetrating the occlusion 198, or a mechanical change, such as a change in speed or torque applied by the atherectomy tool.

[0060] 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 potential energy 122 transmitted from the console unit 120. That is, the rotation assembly 161 is configured to convert energy transmitted from the console unit 120 via the handle 111 and the connector 113 into rotational energy for use by the atherectomy tool 169. The rotation assembly 161 may include a motor, such as an air motor or a turbine-based 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 electrical potential from the handle 111 via the connector 113.

[0061] 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 deliver rotational energy from the rotation assembly 161 to the atherectomy tool 169 so that the atherectomy tool 169 can be used to create a hole, aperture, or otherwise disrupt the occlusion 198, after which the distal balloon 159 of the pulsed endovascular disruption subsystem 150 may be inserted into the lesion 198. The lateral transmission assembly 164 includes a flexible drive shaft for use in delivering the rotational energy to the atherectomy tool 169. The lateral transmission assembly 164 may be configured to be sufficiently flexible to traverse the blood vessel to reach the occlusion, while at the same time being sufficiently rigid so that the lateral transmission assembly can deliver the rotational energy without twisting or kinking. The lateral transmission assembly 164 is disposed distal to the rotation assembly 161 and proximal to the atherectomy tool 169. The lateral transmission assembly 164 has a guidewire lumen through which a guidewire 167 is disposed, in part to guide the atherectomy tool 169 to the occlusion 198 within the blood vessel 199 and in part to provide stability to the lateral transmission assembly 164 while transmitting rotational energy to the atherectomy tool 169.

[0062] In some cases, the lateral transfer assembly may include a fluid bearing configured to partially dissipate heat generated by, for example, rotation of one or more aspects of the lateral transfer assembly, such as rotation of a guidewire present in a fluid, or rotation of a catheter around a guidewire present in a fluid.

[0063] In embodiments of the atherectomy subsystem 160, an advancer is provided that is integrated as part of the rotation assembly 161 and configured to advance and retract the atherectomy tool 169 distally and proximally. Such distal and proximal advancement and retraction is indicated by arrows 168, which show how the distal tool 169 may be advanced toward and retracted from the occlusion 198. In some cases, the advancer is configured to pulse the atherectomy tool 169 in and out of the occluded lesion 198, i.e., to poke one or more surfaces of the occlusion 198.

[0064] 1C, which illustrates in more detail certain aspects of the pulsed intravascular disruption subsystem 150 of the system 100. Referring to FIGS. 1A and 1C, the pulsed intravascular disruption subsystem 150 includes a proximal connector 151 having a proximal port 151a for operably connecting to a pneumatic output of the handle 111, the proximal connector 151 having a proximal flexible tube 151c coupled to a distal port 151b of the proximal connector 151, a distal catheter shaft 154 having an angioplasty balloon 159, e.g., a composite balloon, disposed at the distal end of the distal catheter shaft 154, and a Y-connector 156 connecting 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 amplifier. Also shown is an optional valve 156a located between the distal end of proximal flexible tubing 151c and Y-connector 156.

[0065] If present, the proximal flexible tube 151c acts as a strain relief element between the proximal connector 151 and the Y-connector 156, the distal catheter shaft 154, and the angioplasty balloon 159. If present, the valve 156a may be used to introduce fluid into one or more fluid passageways of the pulsed intravascular ablation subsystem 150. In some cases, the valve 156a is not present. For example, as described herein, the pulsed intravascular ablation subsystem 150 may be a closed or sealed system that is provided to the user pre-filled with a suitable contrast agent containing liquid. In such cases, the valve 156a may not be present because fluid priming is not required to use the pulsed intravascular ablation subsystem 150. In other cases, the valve 156a is a T-connector with a one-way valve protruding from one of the T-connectors. Such a one-way valve 156a facilitates priming of the catheter 154 and the balloon 159. In other embodiments where a T-connector is provided, the connection between the proximal flexible tubing 151c and the Y-connector 156 is made using a rotating luer to facilitate easy positioning of the catheter 154 and valve 156a relative to other aspects of the system 100.

[0066] Further details regarding pulsed intravascular disruption subsystems that may be incorporated into embodiments of the present invention are described in U.S. Pat. No. 1,464,949, U.S. Patent Application Publication No. 2020 / 0046949, pending International Application No. PCT / US2020 / 055458, and pending International Application No. PCT / US2022 / 014785, the disclosures of which are incorporated herein by reference.

[0067] As described herein, the output of the handle 111, including the oscillator 141, is operably connected to the pulsed intravascular disruption 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 potential energy, such as, for example, pneumatic pressure (i.e., first pulse energy), generated by the oscillator 141 into a second potential energy, such as, for example, hydraulic pressure (i.e., second pulse energy). In certain embodiments, the system may include multiple connectors, with individual connectors corresponding to each of the multiple handles. In embodiments, the proximal connector 151 has an interface for releasably and operably connecting to an interface of the handle 111 having the same shape and / or connecting portions and / or interlocking elements as the connector 113 of the atherectomy subsystem 160, such that each of the connector 113 and the proximal connector 151 can be interchangeably and operably connected to the handle 111.

[0068] The output of the proximal connector 151 is operatively connected to the catheter 154 so that the potential energy output from the proximal connector 151 (i.e., the second pulse energy) can be input to the catheter 154 (e.g., one or more fluid channels within the catheter 154 such that the space within the proximal connector 151 is in fluid communication with the catheter 154). In some cases, the pulsed intravascular disruption subsystem 150 may include more than one catheter 154, or the catheter 154 may have more than one fluid channel within or external to the catheter 154, in either case, the distal balloon 159 or various portions of the catheter 154 may operate independently. For example, the distal balloon 159 may include multiple different balloons, each of which is independently pressurized or inflated and deflated, e.g., different embodiments of a cardiac tissue matching element.

[0069] 1A, in the pulsed intravascular disruption subsystem 150 of the system 100, the catheter 154 has a dedicated lumen for the guidewire 157, so that the catheter 154 can be guided to the cardiovascular tissue treatment site 198 using standard over-the-wire (OTW) guidewire techniques. Alternatively, in embodiments, the catheter 154 has one or more guidewire ports for the guidewire 157, so that the catheter 154 and balloon 159 can be guided to the cardiovascular tissue treatment site 198 using standard rapid exchange (RX) guidewire techniques. In other embodiments, the pulsed intravascular disruption subsystem 150 is configured for use in a monorail technique.

[0070] The pulsed intravascular disruption subsystem 150 may be configured with a guidewire entry port 157a for a proximal region of a guidewire 157 passing through a lumen or guidewire channel or ring or loop of the catheter 154. The pulsed intravascular disruption subsystem 150 has a guidewire exit port 157b opposite the guidewire entry port, the guidewire exit port 157b being located in a relatively distal region of the pulsed intravascular disruption subsystem 150, e.g., distal to the distal balloon 159. In embodiments, the guidewire exit port 157b may be oriented substantially parallel to the longitudinal axis of the catheter 154, and thus 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 may be configured with a guidewire 157 and pulsed intravascular disruption subsystem 150 such as an over-the-wire (OTW) system, a rapid exchange (RX) system, or a monorail system.

[0071] In some cases, the atherectomy subsystem and the pulsed endovascular ablation subsystem may share the same guidewire. That is, referring to Figures 1A-1C, guidewire 157 and guidewire 167 may be the same guidewire. In such cases, guidewire 167 is first inserted into blood vessel 199 and used to guide atherectomy subsystem 160 to a desired location so that the atherectomy procedure can be performed. Subsequently, atherectomy subsystem 160 is removed from blood vessel 199 while guidewire 167 remains in place within blood vessel 199, and guidewire 167 is used to guide pulsed endovascular ablation subsystem 150 to a desired location so that the pulsed endovascular ablation procedure can then be performed. In such cases, guidewire 167 is inserted into blood vessel 199 once and used by each of atherectomy subsystem 160 and pulsed endovascular ablation subsystem 150. Embodiments of the present invention have advantages over conventional approaches in that at least one guidewire, such as guidewire 167, can be used in both the atherectomy subsystem 160 and the pulsed intravascular disruption subsystem 150, allowing for a simplified and streamlined process for treating the lesion 198 with each subsystem.

[0072] In an embodiment such as that illustrated schematically in FIG. 1A , a distal balloon 159 is provided at a distal region of the catheter 154. In the system 100, the distal balloon 159 is configured to engage a lesion 198 present in the vessel wall 199 such that application of pressure to the distal balloon 159 causes fissures or other disruption of the calcific deposits at the lesion 198 within the vessel 199. The distal balloon 159 may comprise a non-compliant / compliant material as described herein. In an embodiment, a space within the lesion 198 in which the distal balloon 159 is positioned is formed using an atherectomy tool 169 of the atherectomy subsystem 160. Any convenient balloon may be used for the distal balloon 159, such as multiple balloons or a cardiac tissue-compatible element. Suitable balloons include, but are not limited to, standard angioplasty balloons, such as compliant angioplasty balloons and non-compliant angioplasty balloons. In one embodiment, the balloon is a composite balloon comprising two distinct layers, including a non-compliant layer and a compliant layer.

[0073] In some embodiments, the distal balloon 159 may include two or more balloons, each configured to be independently operable, i.e., independently pressurized and depressurized, for example, by being pressurized by hydraulic pressure transmitted through separate fluid channels in the catheter 154.

[0074] In embodiments, the distal balloon 159 is repeatedly pressurized and depressurized so that fluid, e.g., blood, can perfuse through the distal balloon 159 even as pulsed energy is applied to 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 pulsed cycle when the balloon is substantially deflated). Such a configuration allows blood flow through the distal balloon 159, allowing for extended treatment times.

[0075] Embodiments of the pulsed intravascular disruption subsystem 150 may be further configured to isolate, suspend, or otherwise filter fluid perfusing through the distal balloon 159, for example, to protect the surrounding vasculature from distal embolization. In some cases, the pulsed intravascular disruption subsystem 150 includes a filter disposed distal to the distal balloon 159, which may be attached to the distal balloon 159 and / or the catheter 154 and / or the guidewire 157.

[0076] In embodiments, one or more filters may be attached to a region such as the distal region or distal end of the guidewire 157, 167 or the microcatheter 154 or lateral delivery assembly 164. As lesions 198, e.g., calcified plaque, are removed or disrupted during operation of the atherectomy subsystem or pulsed endovascular disruption subsystem, such filters may include any convenient filter configured to receive and collect removed or fractured portions, e.g., embolic portions, of lesions 198, e.g., calcified plaque, and to immobilize such removed or fractured portions to prevent such removed or fractured portions from traveling throughout the vasculature. 1A-1C illustrate combined atherectomy and pulsed endovascular ablation systems with separate tools, and FIGURES 2A-2B illustrate combined atherectomy and pulsed endovascular ablation systems with integrated tools, as described herein, although the distal filter(s) are not limited to one or the other of these types of embodiments, nor are they limited to one or the other of the atherectomy subsystem and pulsed endovascular ablation subsystem embodiments. Similarly, embodiments of the present invention may be configured such that distal regions of the atherectomy subsystem and / or pulsed endovascular ablation subsystem are configured to aspirate fluid, thereby preventing lesions, e.g., removed pieces of calcified plaque or fragmented portions, e.g., emboli, from being aspirated and removed from the vasculature and traveling throughout the vasculature.

[0077] In some cases, aspects of system 100, such as aspects of console assembly 110 (e.g., controls 130a, 130b or potential source 121), handle 111, oscillator 141, pulsed intravascular disruption subsystem 150 (e.g., proximal connector 151 or distal balloon 159), or atherectomy subsystem 160 (e.g., rotation assembly 161, or connector 113, or lateral transmission assembly 164, or atherectomy tool 169), may be configured to be reusable. For example, aspects of system 100, such as catheter 154, distal balloon 159, lateral transmission assembly 164, or atherectomy tool 169, may be configured to be used only once; that is, such elements may be disposable. The terms "reusable" and "disposable," as used herein and elsewhere throughout this specification, are used for convenience in describing embodiments of the invention as shown in Figures 1A-1C and 2A-2B, described in detail below. However, the invention is not so limited. As such, any part of the system may be configured for single use or multiple use, as desired.

[0078] 2A-2B, another combined atherectomy and pulsed endovascular laser platform is described according to another embodiment, in this case with a combined tool. In FIGURES 2A-2B, elements having the same or similar reference numbers have the same or similar features as corresponding elements in FIGURES 1A-1C, unless explicitly stated otherwise. Descriptions of elements already described above in connection with FIGURES 1A-1C will not be repeated below.

[0079] System 200 includes an integrated atherectomy subsystem 260 and pulsed endovascular disruption subsystem 250 having a combined tool 297 (shown in FIG. 2B ), which are integrated at a region relatively distal to connection 258. This integrated embodiment allows a user, e.g., an operator or clinician, to insert one catheter assembly into a blood vessel, connect atherectomy subsystem 260 to handle 211, perform an atherectomy procedure using the integrated atherectomy subsystem 260, disconnect atherectomy subsystem 260 from handle 211, connect pulsed endovascular disruption subsystem 250 to handle 211, and perform a pulsed endovascular disruption procedure. That is, by using such an embodiment with an integrated tool, a user can insert the integrated atherectomy subsystem 260 and pulsed endovascular disruption subsystem 250 catheter assembly (i.e., combined tool 297) into a vessel only once during the course of an atherectomy and pulsed endovascular disruption procedure, which has the advantage of reducing procedure time and complications by avoiding inserting multiple assemblies or catheters or guidewires into the vessel.

[0080] In some cases, as described in more detail herein, the atherectomy tool 269 is combined with a guidewire 257 used for pulsed endovascular ablation. That is, the atherectomy tool 269 may be provided on a guidewire 257 that is operably connected to the distal balloon 259 of the pulsed endovascular ablation subsystem 250. In such cases, the guidewire 257 may be referred to as an atherectomy wire. Similar to a conventional guidewire, the atherectomy wire 257 has a proximal end (i.e., relatively close to the connector 251 and the rotating assembly 261) and a distal end (i.e., relatively close to the distal balloon 259 and the atherectomy tool 269). In embodiments, the distal end of the guidewire 257 may be coated with an abrasive material to form a burr that forms the atherectomy tool 269. In other cases, the burr that forms the atherectomy tool 269 may be assembled to the shaft of the guidewire 257.

[0081] Depending on the axial position of the atherectomy tool 269, the tool can be used in two ways: (1) to cross a narrow lesion 298 in a blood vessel 299 and then grind within the lesion, or (2) to create a new channel by butting and grinding or drilling a hole in the narrow or occluded blood vessel 299. The proximal end of the guidewire 257 can be backloaded onto the pulsed endovascular ablation catheter 254 or a region thereof to support the pulsed endovascular ablation catheter 254. The pulsed endovascular ablation catheter 254 then supports the atherectomy tool 269 during rotation or orbital movement of the atherectomy tool 269 and provides a receiving area for the guidewire 257 to rotate. The lateral transmission assembly 264 includes the guidewire 257 and the catheter 254. That is, in the region distal to the connection 258, the lateral transmission assembly 264 has a guidewire 257 present within the catheter 254, and in the region proximal to the connection 258, the lateral transmission assembly 264 has a guidewire 257 that is separate from the catheter 254 or is not sealed within the catheter 254.

[0082] Relatively distal from the connection 258, the lateral transmission assembly 264 has a guidewire 257 that is integrated with the catheter 254 so that the guidewire 257 can support the catheter 254, and the catheter 254 can support the atherectomy tool 269 and provide a storage area for the lateral transmission assembly 264 to rotate or rotate.

[0083] Because aspects of both the pulsed endovascular disruption subsystem 250 and the atherectomy subsystem 260 are integrated at and distal to the junction 258, the system 200 is an embodiment of a combined atherectomy and pulsed endovascular disruption platform with a partially combined tool. As shown, relatively distal to the junction 258, the catheter 254, lateral transmission assembly 264, and guidewire 257 are integrated such that the guidewire 257 may reside within the catheter 254 or may be otherwise attached to the catheter 254. In some embodiments, the lateral transmission assembly 264 includes the guidewire 257, which is configured to rotate, thereby transmitting energy from the rotation assembly 261 to the atherectomy tool 269 within the catheter 254. That is, the rotation assembly 261 rotates the guidewire 257 within the catheter 254. In some cases, catheter 254 and guidewire 257 are configured to form a fluid bearing to facilitate rotation of guidewire 257, and particularly to facilitate heat dissipation associated with rotation of guidewire 257.

[0084] 2A-2B, similar to FIGS. 1A-1C, the atherectomy lateral transmission assembly 264 is connected to a rotational assembly 261 that provides rotational motion for the atherectomy tool 269. As described herein, the rotational assembly 261 may include a motor, e.g., a motor configured to rotate the lateral transmission assembly 264. This rotational motion is used to perforate areas of the lumen 299 that are too narrow for the pulsed endovascular ablation catheter 254 and distal balloon 259 to traverse. Such perforation is performed to expand the lumen 299 within a lesion 298, such as an occlusion and / or calcification, so that pulsed endovascular ablation can be performed on the calcification 298 using the distal balloon 259 of the pulsed endovascular ablation subsystem 250. In an embodiment of a combined atherectomy and pulsed intravascular atherectomy platform with a combined tool, such as system 200, after a hole is drilled or dilated in lesion 298, distal balloon 259 is positioned relative to lesion 298, and the combined tool, including atherectomy tool 269, distal balloon 259, guidewire 257, catheter 254, and lateral transmission assembly 264, can be advanced by moving along longitudinal axis 268 so that pulsed energy can be applied to lesion 298 through the hole drilled or dilated by atherectomy tool 269 to fracture or otherwise fragment or destroy calcified plaque within the lesion. In such cases, the distal balloon 259 may be positioned to deliver pulsed energy to the lesion 298 through a hole drilled or enlarged by the atherectomy tool 269, without the need to remove the atherectomy subsystem 260 from the lumen 299. Instead, the distal balloon 259 may be positioned within or near the lesion 298, for example, by moving the catheter 254 with the distal balloon 259 in a relatively distal direction within the vessel 299, and the pulsed endovascular disruption subsystem 250 may be engaged to deliver pulsed energy to the lesion 298.

[0085] In embodiments, the atherectomy subsystem 260 is removed from the handle 211 and the pulsed endovascular disruption subsystem 250 is attached to the handle 211 without the need to reinsert an additional or different tool into the lumen 299. That is, because the pulsed endovascular disruption subsystem 250 and the atherectomy subsystem 260 are both integrated at the distal region of the connection 258, no additional tool needs to be inserted into the vessel 299 when transitioning from an atherectomy procedure to a pulsed endovascular disruption procedure.

[0086] 2B is a schematic diagram of a combined tool 297 of system 200 including aspects of atherectomy subsystem 260 and pulsed endovascular disruption subsystem 250, according to an embodiment of the present invention. Atherectomy tool 269 resides at a distal region of guidewire 257 and is configured to receive power from rotation assembly 261 so that atherectomy tool 269 can puncture a lesion 298 within blood vessel 299. In the illustrated embodiment, the lateral transmission assembly includes guidewire 257. Rotation assembly 261 is operably connected to connector 213, which is itself operably connected to handle 211. As described herein with respect to connector 113 of FIGS. 1A-1C, connector 213 may also be a pass-through device configured to transfer potential energy from the output of handle 211 to rotation assembly 261.

[0087] In the combined tool 297, the atherectomy tool 269 is directly connected to the distal balloon 259 of the pulsed endovascular disruption subsystem 250 and the catheter 254 such that the guidewire 257 may be housed within the catheter 254 over a portion of the lateral extent of the guidewire 257. The distal balloon 259 receives power transmitted from the proximal connector 251 through the catheter 254 to perform the pulsed endovascular disruption procedure. When using the combined tool 297, the atherectomy tool 269 of the atherectomy subsystem 260 may be used to create a hole or dilate an opening in a lesion 298 of the blood vessel 299. Upon creating or dilating such a hole, the catheter 254 of the pulsed endovascular disruption subsystem 250 may be advanced distally within the blood vessel 299 such that the distal balloon 259 interacts with the lesion 298 through the newly created or dilated hole. Once the distal balloon 259 can be positioned at the desired location of such an opening in the lesion 298, pulsed endovascular ablation can be initiated by transmitting pulsed energy from the proximal connector 251 to the distal balloon 259. That is, a key feature of the combined tool 297 is that the atherectomy tool 269 resides on the guidewire 257, which itself is connected to the distal balloon 259, such that the atherectomy subsystem 260 does not need to be removed from the blood vessel 299 before initiating the pulsed endovascular ablation procedure using the pulsed endovascular ablation subsystem 250, instead of the atherectomy tool 269 utilizing a separate wire or catheter mechanism. In such an embodiment, the guidewire 257 supports the catheter 254 and balloon 259, along with the atherectomy tool 269, and vice versa.

[0088] In embodiments having a combined tool, such as combined tool 297, system 200 is an integrated atherectomy and pulsed endovascular disruption system. In embodiments, atherectomy subsystem 260 and pulsed endovascular disruption subsystem 250 have a combined tool 297. For example, atherectomy subsystem 260 and pulsed endovascular disruption subsystem 250 may have a common distal region, such as a region of system 200 distal to junction 258. In some cases, both atherectomy subsystem 260 and pulsed endovascular disruption subsystem 250 have a common guidewire 257. In system 200, the lateral transmission assembly is guidewire 257.

[0089] System 200 may be configured to be an over-the-wire (OTW) system. For example, in some cases, a guidewire extends over a substantial length of atherectomy subsystem 260 and pulsed endovascular disruption subsystem 250. In other cases, system 200 may be configured to be a rapid exchange (RX) system. For example, in some cases, a guidewire 257 extends over only the distal regions of atherectomy subsystem 260 and pulsed endovascular disruption subsystem 250. In still other cases, system embodiments may be configured as monorail systems. That is, system embodiments may utilize a guidewire in a monorail technique.

[0090] In embodiments of a system including a composite tool with a common guidewire shared between the atherectomy subsystem and the pulsed endovascular disruption subsystem, a distal region of the guidewire may be coated with an abrasive material, and such a coating of abrasive material may include an atherectomy tool, e.g., a distal burr. In some cases, the coated portion of the abrasive material has a predetermined diameter selected based on the treatment effect. In other cases, the coated portion of the abrasive material has a predetermined diameter selected based on the diameter of the distal balloon of the pulsed endovascular disruption subsystem. In embodiments, such predetermined diameter is selected so that the distal balloon of the pulsed endovascular disruption subsystem can be inserted into the hole created by the abrasive material.

[0091] In other cases of systems including a combined tool with a common guidewire shared between the atherectomy subsystem and the pulsed endovascular ablation subsystem, the pulsed endovascular ablation subsystem has a guidewire lumen. In such cases, the common guidewire may be disposed within the guidewire lumen of the pulsed endovascular ablation subsystem. In some embodiments, the system may further include a filter, e.g., filter-containing region 296, disposed on the guidewire distal to the atherectomy tool. In embodiments, such a filter is configured to protect the vasculature from distal embolization, for example, in connection with lesion perforation and / or application of pulsed energy to the lesion.

[0092] In other embodiments of the invention that do not include a composite tool or a composite distal region, the atherectomy subsystem and the pulsed endovascular disruption subsystem have separate distal regions, and in such embodiments that do not include a composite tool, the catheter element of the pulsed endovascular disruption subsystem is separate from the atherectomy subsystem.

[0093] In an embodiment of a method for using a system of the present invention including a composite tool, such as system 200, a sheath / guide catheter is inserted into blood vessel 299, guidewire 257 is inserted into blood vessel 299 along with atherectomy tool 269, pulsed intravascular disruption balloon 259 and catheter 254 are loaded onto guidewire 257 so that guidewire 257 provides stability to catheter 254, guidewire 257 is loaded onto rotating assembly 261, which is an atherectomy motor, guidewire 257 is secured to rotating assembly 261, connector 213 is connected to handle 211, and a handle button or the like is held to advance guidewire 257, which in turn advances atherectomy tool 269, thereby performing a treatment including an atherectomy procedure, generating sufficient luminal gain to allow pulsed intravascular disruption balloon 259 to enter lesion portion 298, and atherectomy tool 269 is inserted into blood vessel 299. The guidewire 257 is pushed distally further into the lesion 298 so that the atherectomy tool advances beyond the treatment site, i.e., to a position where an atherectomy tool has been used to dilate the lesion, the pulsed endovascular disruption balloon 259 is advanced across such treatment site, the atherectomy connector 213 is detached from the handle 211, the pulsed endovascular disruption proximal connector 251 is connected to the handle 211, and the pulsed endovascular disruption subsystem 250 is used to treat, i.e., to deliver pulsed energy to the lesion 298 via the distal balloon 259. The atherectomy connector 213 can be detached from the handle 211 and the proximal connector 251 can be connected to the handle 211 because each of such elements has an interface having a feature, such as a shape or interlocking portion or connector or other alignment feature, that allows each of the atherectomy connector 213 and the proximal connector 251 to be interchangeably and operably connected to the handle 211.

[0094] console Console devices according to embodiments of the present invention may vary. In some cases, the console device is a compact, stand-alone unit configured for ease of use and versatility. The console device may have an enclosure that protects internal components and provides a secure, stable base for operation. The enclosure may be configured to be durable and resistant to damage from handling and environmental factors such as dust and moisture. The console device may be configured to attach to an IV pole, for example, using clamps, such as two clamps that securely hold the console device in place. In such embodiments, the clamps can be adjusted to fit various IV pole sizes, ensuring compatibility with a wide range of equipment. Additionally, the console device may have a table stand that provides stability when the console device is used on a flat surface.

[0095] In some cases, the console device has a gas inlet port that allows for the connection of high-pressure gas, such as compressed gas, carbon dioxide, or nitrogen. The gas inlet port may be configured to ensure a safe and leak-free connection to a gas source. The console device may have a pressure-reducing regulator that regulates the incoming high-pressure gas to a desired output pressure. The pressure-reducing regulator may be configured to accurately and consistently regulate the pressure to ensure safe and effective delivery of the regulated gas. The console device of embodiments of the present invention may have a proportional or electronically controlled valve that outputs either the desired pressure or flow rate. The valve may be configured to accurately and precisely control the output pressure or flow rate to ensure safe and effective delivery of the regulated gas.

[0096] Since electrical power is used to operate the console device, electrical power may be supplied through a power inlet cable connector. The cable connector may be configured to be safe and resistant to damage from handling and environmental factors. The console device may have a harness that provides connectivity to the internal components to ensure a safe and reliable electrical connection. If desired, the console device may have a voltage converter that converts the input power to a voltage required by the internal components. The voltage converter may be configured to be efficient, reliable, and ensure stable operation of the console device.

[0097] In embodiments, the console device may have fluid management elements for handling fluid output, for example, of pressurized sterile saline. The fluid management elements may include a reservoir of sterile saline, a pump for pressurizing the sterile saline, and tubing for directing the sterile saline to the treatment area. The fluid management elements may be configured to ensure sterile and safe delivery of the pressurized saline, ensuring the overall safety and effectiveness of the treatment process. The fluid management system may be further configured for ease of use and maintenance, ensuring efficient operation and maintenance of the console device.

[0098] The console device may utilize various sensors to monitor its performance and ensure the safe delivery of potential energy, such as, for example, high-pressure gas. For example, pressure transducers may be used to measure the pressure within the system and may be used to measure the remaining amount of gas. Optical or other types of flow sensors may be used to detect changes in gas flow, and temperature sensors monitor the temperature of components to prevent overheating or cold environments. For example, humidity sensors located inside and / or outside the console may be used to ensure humidity levels are within acceptable ranges, detect leaks, and / or detect condensation buildup due to exhaust gases. Additionally, connection sensors may be used to detect when a tether, such as those described herein, is properly connected to the console and when the tether is disconnected. In embodiments, this information may be important to ensure the console is operating as intended and can stop the flow of gas if a disconnection is detected. Using a combination of these sensors, in embodiments, the console can monitor its own performance and make adjustments to ensure the safe and effective delivery of potential energy, such as, for example, high-pressure gas. The sensors may be configured to provide valuable feedback to the system, allowing it to operate more efficiently and effectively while further protecting the user and patient from potential risks.

[0099] The console device may have a display screen that provides real-time information to the user, such as pressure and flow measurements, treatment time, and other relevant information. The display screen may be easy to read and provide clear and concise information to the user. In embodiments, the console device has a display screen that presents information to the user, including, for example, the type, intensity, and duration of the current treatment. The console device may further include software that executes a program that determines the type, intensity, and duration of treatment, which can be pre-set, user-adjusted, based on sensor input, or based on artificial intelligence, machine learning, etc.

[0100] The console device may further include an adjustment element that can change device settings based on user feedback or other sensor input, and may be configured to allow the console device to continuously monitor and adjust its own performance to ensure that the regulated gas output is maintained within safe and effective parameters.

[0101] The software of the console device may be configured to receive various sensor inputs and adjust treatment settings in real time. The software may be configured to continuously monitor inputs from various sensors, such as sensors measuring gas pressure, flow rate, images, vascular pressure and / or flow rate, and patient vital signs. The software then uses this input to adjust treatment settings, such as the intensity and duration of the adjusted gas output. The software can be programmed with various presets for different types of treatments, which can be changed by the user or based on artificial intelligence algorithms. Such artificial intelligence algorithms can analyze the sensor inputs to determine whether treatment settings need to be adjusted to ensure the adjusted gas output is maintained within safe and effective parameters. In addition, the software can incorporate user feedback, such as manual adjustments by a caregiver or patient, to further refine the treatment settings. The software incorporates this feedback and adjusts the treatment settings accordingly to provide the most effective and efficient treatment.

[0102] The console device may be configured to self-adjust based on a feedback model or a feedforward model, providing a highly adaptive and responsive system for supplying potential energy, e.g., providing 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 may monitor gas pressure and adjust regulating elements to maintain the gas pressure within a safe and effective range. Software further analyzes the sensor inputs to adjust treatment settings, such as the intensity and duration of regulated gas output, in real time. A feedforward model refers to adjustments made by the console device based on predicted future inputs or performance results. For example, the software may be programmed with artificial intelligence algorithms that analyze sensor data and predict likely future changes in the patient's condition. Based on these predictions, the console device can proactively adjust treatment settings to ensure that regulated gas output is maintained within safe and effective parameters.

[0103] In embodiments, the console device may communicate with a cloud-based server, or cloud-based data, or other previously stored data to improve or recommend treatment profiles. This communication allows the console device to access a wealth of information and knowledge to provide a more personalized and effective treatment experience for the patient. In embodiments, the console device may communicate with a cloud-based database or electronic medical record system to access a patient's past treatment history and other relevant information, such as the patient's medical history, current medications, and vital signs. This information may then be used to tailor treatment settings to the individual patient, providing a more personalized and effective treatment experience. The console device may also be configured to access previously stored data to improve the performance of the console device over time. For example, the console device may analyze past treatment data to identify trends and patterns and use this information to improve the accuracy and efficiency of future treatments.

[0104] In some cases, the console device may be configured to communicate with other devices, such as remote monitoring devices, to access additional information that can be used to improve treatment profiles. For example, the console device may be configured to receive data from a wearable device that measures a patient's vital signs and use this information to adjust treatment settings and ensure that regulated gas output is maintained within safe and effective parameters. In embodiments, the console device may communicate with a wide range of external devices to be programmed, receive information from, or provide information to. This communication is supported via a variety of wired and wireless communication protocols, including RS232, USB, Ethernet, Wi-Fi, and Bluetooth®. Additionally, the console device may support other communication platforms, such as ZigBee, Near Field Communication (NFC), Message Queue Telemetry Transport (MQTT), MODBUS, and Controller Area Network (CAN), depending on the specific needs and requirements of the console device. These communication protocols allow the console device to be highly flexible and adaptable, ensuring compatibility and communication with a wide range of external devices.

[0105] The console device may have a connector, such as a pair of mating connectors, that allows for a secure and reliable connection between the console device and the tether. In such a case, one connector may be fixed to the outside of the console while the other connector is connected to the tether. The connector may mate with two gas ports (intake and exhaust) and an electrical connector that provides power and communications.

[0106] 3A-3B illustrate console devices 300a, 300b according to an embodiment of the present invention. The console devices 300a, 300b are configured to provide potential energy in the form of high-pressure gas, for example, from a tank 321b. Connectors 310a, 310b are configured to connect the console devices 300a, 300b to a high-pressure gas source 321b. Input / output connectors and controls 320a may be used to provide regulated high-pressure gas to other aspects of the system (e.g., the atherectomy subsystem and the pulsed intravascular disruption subsystem, in each case via a handle) and may include a console input / output port, which may optionally include an HDMI® port or a USB port for transmitting data to and from the console devices 300a, 300b. A display 330a may be used to provide real-time information, such as pressure and flow measurements, treatment times, and other relevant information, to a user or operator, such as a clinician. The console 300a includes a console input 340a for inputting to controls located within the console 300a to adjust system behavior. The console input 340a includes buttons or controls for selecting treatment intensity and mode, and an emergency shut-off button for enabling or disabling the console assembly 300a. The console assemblies 300a, 300b further include console housings 390a, 390b configured to form a housing and protect the console elements, for example, during accidental dropping or packaging. The console housings 390a, 390b, if present, may be made of a suitable rigid material, such as a polymeric material, and may be transparent or opaque as desired. The 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 being output at the handle connection 320b.

[0107] As discussed, the systems of the present invention include a console, also referred to as a console unit, console subsystem, or console assembly, which in embodiments of the systems of the present invention is used to generate the power and control necessary to treat biological tissue, such as cardiovascular tissue, using the system.

[0108] In embodiments of the console according to the present invention, the console includes or is operably connected to a potential source. The potential source of embodiments of the present invention is configured to provide energy that may be regulated as desired by a regulator. Any convenient potential source may be used, and examples of potential sources include voltage sources, pressure sources, electromagnetic sources, electric field sources, chemical sources, etc. In some embodiments, the potential source is a pressure source, and examples of suitable pressure sources include, but are not limited to, compressed gas cylinders, compressors, etc. If desired, the potential source may be operably coupled to a regulator, which functions to modulate the energy from the potential source into an appropriate form that may be further acted upon, for example, by an oscillator or other aspect of the manifold assembly. For example, if the potential source is a high-pressure gas source, the regulator may function to adjust the pressure of the gas to an appropriate value that may be input to the oscillator. In addition to positive potential sources (e.g., high-pressure gas), potential sources of interest may also have a negative potential relative to a reference or standard potential, for example, a potential source configured to provide a vacuum potential relative to standard atmospheric conditions.

[0109] In some embodiments, the console includes two or more potential sources. In embodiments with two or more potential sources, the potential energy provided by each potential source may all be of the same type, or may be a combination of different potential types. For example, each potential source may be a pressure source (of the same or different potential levels), or alternatively, one potential source may be a pressure source and another potential source may be a voltage source.

[0110] In embodiments, the console assembly may further include one or more regulators (i.e., power regulators), output ports, and controls. As described above with respect to the power regulator, in embodiments, the potential of the potential source may be adjusted from a first input potential to a second potential, e.g., a potential suitable for ultimately transmitting to the oscillator or another aspect of the manifold assembly or to the atherectomy subsystem or pulsed intravascular disruption subsystem for treatment of biological tissue, such as cardiovascular tissue. The potential of the potential source may be adjusted to a predetermined value, a user-set value, or may be adjusted in response to various feedback inputs that occur during a procedure. In some cases, the potential of the potential source may be dynamically adjusted based at least in part on conditions associated with a procedure involving the application of pulsed energy to biological tissue, such as cardiovascular tissue, e.g., based on changes in tissue compliance during a procedure. In some cases, the potential of the potential source may be adjusted in real time or substantially in real time. In some embodiments, the potential of the potential source may be adjusted to an optimal value for a given procedure. For example, the potential of the potential source may be adjusted to an optimal value for treating diseased cardiac tissue, such as cardiac tissue having calcified deposits or occlusions, or for example, the potential of the potential source may be adjusted to an optimal value for treating diseased cardiac tissue using the atherectomy subsystem and the pulsed endovascular ablation subsystem. In some cases, one or more inputs from one or more of the console, the handle, the atherectomy subsystem, the pulsed endovascular ablation subsystem, the user, or the generator, or from a source external to the system (e.g., other measurements of the subject, such as images of the subject), may be used to determine and then adjust to optimal treatment conditions, such as the output potential of the potential source appropriate for the desired treatment (e.g., treatment using the atherectomy subsystem and treatment using the pulsed endovascular ablation subsystem of a combined system).

[0111] In embodiments including a regulator (i.e., a power regulator or potential regulator) configured to adjust the potential of a potential source, such regulator may be a passive regulator (i.e., a preset regulator or a user-adjusted regulator) or an active regulator (i.e., a regulator controlled using, for example, an electrical impulse or other dynamic signal, e.g., from a controller). Regulators of interest may include regulators typically used for fluid regulation, such as directional or diaphragm valves, electrical regulation, such as voltage regulators, optical power regulation, etc. In embodiments including two or more potential sources, the potentials of the various potential sources may be regulated together or separately.

[0112] In embodiments, the regulated and / or unregulated potential (i.e., potential energy) from the potential source is output via an output port operably coupled to the handle for transmission to the atherectomy subsystem and / or pulsed intravascular disruption subsystem. In embodiments, any convenient output port may be used, such as a commercially available connector, such as a pneumatic, hydraulic, electrical, or optical connector. In some cases, the unregulated or regulated potential energy may be converted to another form of energy before being output from the console, or in some cases after being output from the console, i.e., before being passed or otherwise transmitted to other aspects of the system, or in some cases after being passed or otherwise transmitted to other aspects of the system.

[0113] In some cases, a console may include two or more physically separate or connected units, i.e., console units, that may be operably interconnected (e.g., electrically, fluidly, using radio frequency (RF)), i.e., the console may have an integral assembly or two or more separate, operably connected units.

[0114] In some cases, at least some of the console elements are provided within a unit that is configured to be hand-held or hand-operated, e.g., moved by hand. The form factor of such a unit may vary as desired, but in some cases, such a unit may be configured substantially as a rectangular box having a height in the range of 10-100 cm, e.g., 20-30 cm, a width in the range of 5-100 cm, e.g., 10-20 cm, a depth in the range of 10-100 cm, e.g., 20-30 cm, and a mass in the range of 1-20 kg, e.g., 5-8 kg.

[0115] In embodiments, the console may have a first console element housing the potential source and regulators and actuators for the pressure source, e.g., operable buttons. The console may also have electrical connectors for electrically connecting to various other components of the system, as desired. For example, the electrical connectors may be used to power sensors configured to receive data regarding the position and / or configuration of the distal balloon or atherectomy tool, e.g., its position or orientation relative to the tissue being treated, e.g., cardiovascular tissue, or a lesion, e.g., a chronic total occlusion, or pressure or volume measurements, and to collect such data regarding the treatment using the system.

[0116] In some cases, at least some of the console elements are provided in an attachable unit configured to be placed or secured on or near an operating table near a subject, i.e., a patient, so that an operator, e.g., a physician, does not need to physically interact with the console assembly to treat the subject (e.g., the operator does not need to be physically present in an operating or treatment room but can communicate with the system remotely from a remote location). In such cases, the attachable unit is configured to be easily clamped, secured, or independently stabilized on or near the operating table and can be operated by a distal control unit. In such cases, the attachable unit may have a communicator providing communication between the console assembly and the distal control unit, which may be implemented by any desired hardware and / or software configuration and may be configured to communicate using a wired or wireless protocol.

[0117] The console and / or its potential source used in the systems of the present invention may be configured to be reusable or single-use, as desired. The console assembly used in the systems of the present invention may be configured to receive a sterile sleeve so that it may be used without contaminating the sterile field of the operating room. Further details regarding aspects of the console unit, potential source, regulator, etc. that may be used in embodiments of the present invention are described in U.S. Pat. No. 1,464,949, U.S. Patent Application Publication No. 2020 / 0046949, pending International Application No. PCT / US2020 / 055458, and U.S. Application No. 63,274,832, the disclosures of which are incorporated herein by reference.

[0118] Control unit An embodiment of a console of a system of the present invention includes one or more controls, also referred to as a control unit, control assembly, or control subsystem. System embodiments may utilize a first logic control operably connected to the atherectomy subsystem and a second logic control operably connected to the pulsed intravascular disruption subsystem. In embodiments, such first and second logic controls may be referred to as controllers. In embodiments, such first and second logic controls specifically control the amount and duration of energy delivered to tissue, e.g., cardiovascular tissue, by each of the atherectomy subsystem and the pulsed intravascular disruption subsystem.

[0119] In some cases, system embodiments may utilize the controller to measure the effect of a treatment on cardiovascular tissue, such as the extent to which an atherectomy tool penetrates a lesion containing calcified tissue or the extent of destruction of a lesion containing calcified tissue. For example, the controller may be configured to measure the extent to which a treatment causes a change in the compliance of the cardiovascular tissue. In still other cases, system embodiments may utilize the controller to control the distal and proximal movement of the atherectomy tool as it penetrates an occlusion.

[0120] In embodiments, the controller may be connected to receive information from and / or regulate or control one or more aspects of the system, including the system's console, e.g., the pressure source or its regulator, the handle, the oscillator, the atherectomy subsystem, or the pulsed intravascular disruption subsystem. The controller may be further configured to receive information from and / or control external systems, such as an electrocardiogram (ECG), an intravascular or external pressure monitor, a blood volume sensor, a patient vitals sensor, or an imaging system, such as an imaging system utilizing fluoroscopy, intravascular ultrasound (IVUS), or optical coherence tomography (OCT). Additionally, the controller may include multiple control units, e.g., the first and second logic controllers described above, interconnected such that one or more of the units communicate synchronously with each other.

[0121] In some cases, the controller or a control unit with the controller may be configured to communicate with elements of the system so that the energy delivered via the atherectomy subsystem with an atherectomy tool or the pulsed endovascular disruption subsystem with a distal balloon is appropriate in each case, i.e., appropriate for the particular procedure involving the use of an atherectomy tool and / or the application of pulsed energy to tissue. In other embodiments, the controller may receive information, e.g., data signals, regarding the status of the cardiovascular tissue treatment, e.g., an atherectomy treatment, from a sensor that provides information regarding, e.g., the position of the atherectomy tool relative to the occlusion, the extent to which the occlusion has been perforated, the extent to which the lesion or occlusion has been dilated, etc.

[0122] In embodiments, the controller may be configured to provide feedback to an operator of a system of the present invention in any convenient manner. In some cases, the controller may be configured to provide tactile feedback to the operator, such as by vibration. For example, the controller may be configured to vibrate a handle or vibrate another interface upon a relevant change or determination of a sensor measurement, such as penetration of a hole through an occlusion, or a related change in cardiovascular tissue compliance. Such tactile feedback may be used in connection with instructing an operator of an embodiment of the system to change a configuration of the system.

[0123] Manifold assembly, oscillator, or switch An embodiment of the system of the present invention includes a manifold assembly. The manifold assembly, also referred to as a manifold unit or manifold subsystem, may be used in embodiments of the system of the present invention to receive energy transmitted from a potential source of a console and to transmit such energy to the atherectomy subsystem and the pulsed endovascular disruption subsystem. In embodiments, the manifold assembly includes an oscillator configured to generate pulsed energy from the energy transmitted from the potential source. In such cases, the oscillator is used to modulate the magnitude and / or timing and / or frequency of potential energy from the potential energy source to provide a desired energy for use in delivering pulsed energy to biological tissue, such as cardiovascular tissue, via the atherectomy tool and / or distal balloon. Pulsed energy may be utilized by the atherectomy subsystem, for example, in conjunction with rotation or orbital movement of the atherectomy tool, and possibly distal and proximal movement of the atherectomy tool, to poke in and out of a lesion, such as a chronic total occlusion. In embodiments, the manifold assembly may be disposed within a handle, such a handle including an oscillator as described herein and configured to be manually manipulated by an operator.

[0124] In embodiments, the manifold subsystem has an input connection operably connected to the output of the console, one or more oscillators, and an output connection for use in ultimately delivering energy to the atherectomy subsystem and / or the pulsed endovascular disruption subsystem. In embodiments of the handle, the handle may be configured for use with each of the atherectomy subsystem and / or the pulsed endovascular disruption subsystem, or may be configured to have separate outputs for each such subsystem. In some embodiments in which the console includes one or more console subunits, the manifold input connection includes an input connection to one or more of the console subunits of the console, as described herein. As described above, in embodiments, the manifold subsystem is configured to receive energy delivered from the console and ultimately output energy to the atherectomy subsystem and the pulsed endovascular disruption subsystem. The manifold subsystem may be configured to receive various forms of potential energy (e.g., voltage potential, electromagnetic potential, pressure potential, etc.) from one or more consoles and distribute that energy to one or more oscillators of the manifold assembly. In embodiments, any convenient input / output connection may be used, such as commercially available connectors, for example pneumatic, hydraulic, electrical, or optical connectors.

[0125] In some cases, the manifold assembly or handle may receive potential energy from one or more console subunits of the console and distribute that potential energy to one or more oscillators of the manifold assembly or handle. In some cases, there is a one-to-one correspondence between console subunits and oscillators of the manifold subunits or handle. In other cases, one console subunit may provide energy to one or more oscillators. In still other cases, one or more console subunits may provide energy to one oscillator, i.e., the potential energy of one or more console subunits is combined in one oscillator.

[0126] In embodiments, the energy imparted to the oscillator includes a regulated or unregulated fluid under pressure. The oscillator may be operable to output a pulsed pressure output and / or a static pressure output. In embodiments in which the potential energy imparted by the console is a regulated or unregulated fluid under pressure, the oscillator may include a solenoid valve. Such a solenoid valve may include, for example, a two-position, three-way, normally closed solenoid valve. In such cases, the solenoid valve is configured to receive the regulated or unregulated fluid at high pressure. Such a solenoid valve may be configured to have two modes: an "on" mode and an "off" mode. Such a solenoid valve may be configured to have three ports: a port operably connected to the regulated or unregulated fluid at high pressure (i.e., an input port), a port operably connected ultimately to the catheter assembly (i.e., a first output port), and an exhaust port (i.e., a second output port). The solenoid valve may be configured such that when turned on (i.e., in "on" mode), the solenoid valve allows high-pressure regulated or unregulated fluid to be delivered, i.e., delivered downstream in the system, for example, to the atherectomy subsystem and / or the pulsed intravascular disruption subsystem. The solenoid valve may be further configured such that when turned off (i.e., in "off" mode), the solenoid changes or reverses the port to which it is connected, and the distal side of the solenoid valve is vented (e.g., vented to atmosphere or vacuum). That is, in the "off" mode, the first output port may be connected to the second output port, thereby venting the high-pressure fluid distal to the solenoid valve.

[0127] In some embodiments, the frequency and / or duty cycle of the oscillator may be adjusted to generate appropriate output for the procedure and the atherectomy subsystem, including the atherectomy tool, or the pulsed endovascular disruption subsystem, including the distal balloon. In various embodiments, one or more oscillators may be configured to oscillate at one or more frequencies and / or duty cycles. In some cases, the oscillator is configured to oscillate at a frequency in the range of 0-50 Hz, e.g., 1-10 Hz, or 10-20 Hz, or 21-30 Hz, or 31-40 Hz, or 41-50 Hz, and at a duty cycle in the range of 10%-90%, e.g., 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90%. In other cases, for example when the oscillator is configured to deliver pulsed pressure pulses using fluid pressure for procedures including application of an atherectomy subsystem to cardiovascular tissue, the oscillator may be configured or controlled to oscillate at a frequency within a range of 0.25 Hz to 5 Hz, e.g., 1 Hz or 2 Hz or 3 Hz or 4 Hz or 5 Hz, and with a duty cycle within a range of 10% to 90%, e.g., 10% or 20% or 30% or 40% or 50% or 60% or 70% or 80% or 90%. If the oscillator is configured to deliver pulsed energy, including a light source or high voltage source, the oscillator may oscillate at a frequency in the range of 0.1 Hz to 1 GHz, e.g., 1 Hz or 2 Hz or 3 Hz or 4 Hz or 5 Hz or higher, and with a duty cycle in the range of 0.0001% to 90%, e.g., 0.001%, 0.01%, 0.1%, 1%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90%.

[0128] Further details regarding aspects of manifold assemblies, handles, oscillators, etc., and elements thereof that may be used in embodiments of the present invention are described in U.S. Pat. No. 1,464,949, U.S. Patent Application Publication No. 2020 / 0046949, pending International Application No. PCT / US2020 / 055458, U.S. Application No. 63,274,832, and U.S. Application No. 63,545,060, the disclosures of which are incorporated herein by reference.

[0129] In some embodiments, the output from the oscillator, or in embodiments having two or more oscillators, the outputs from the various oscillators, may be delivered to one or more locations. In other embodiments having two or more oscillators, the oscillators may be synchronized with one another, e.g., so that the pulsed energy delivered by each oscillator is synchronized as desired, e.g., in terms of magnitude, frequency, phase, duty cycle, etc. In other embodiments having one or more oscillators, the oscillators may be synchronized with an external source, system, or sensor, e.g., electrocardiogram (ECG) results, or may be adjusted based on feedback from the controller or other subsystems (e.g., volume or pressure measurements from the atherectomy subsystem or pulsed endovascular disruption subsystem). In other embodiments, one or more oscillators may be controlled based on data regarding the position of the atherectomy tool, i.e., data regarding the occlusion, e.g., data regarding whether the atherectomy tool has punctured a lesion such as a chronic total occlusion. That is, the controller may be configured to adjust the behavior of the oscillators based at least in part on such data.

[0130] In embodiments, the manifold assembly or handle may further include multiple inlet sources (e.g., connections to a console unit), a housing (e.g., a manifold or handle housing for the manifold assembly or handle), multiple oscillators, oscillator connection points (e.g., for transmitting energy from the oscillators to the catheter assembly), controller connection points (e.g., for transmitting input from sensors within and / or external to the system), and user feedback and / or control areas (e.g., for a user to adjust the operation of the system). In embodiments, the manifold assembly may be located wholly or partially within the handle of a system as described herein. In other embodiments, the manifold assembly may be located wholly or partially within the console of a system as described herein.

[0131] In various embodiments, the manifold assembly or handle, like other aspects of the systems of the present invention, may be configured to be disposable or reusable. If the manifold assembly or handle assembly is reusable and may contact an area of ​​a patient, such assembly may be configured to be covered with a disposable sterile sleeve or bag. In certain embodiments, the manifold assembly may be configured as part of a console (i.e., such that the console and manifold assembly elements are disposed within a common housing). In other embodiments, the manifold assembly may be configured in the form of a handle, i.e., in the form of a handle for a system embodiment, so that an operator of the system may hold the manifold assembly during use or a procedure.

[0132] In some embodiments, elements of the control subsystem or controls may be located within the manifold assembly housing and / or the console housing and / or the handle, as described above. In some cases, the manifold assembly and / or the console and / or the handle include a user interface configured to allow an operator of the system to access the manifold assembly or console to start or stop treatment, adjust treatment intensity, adjust treatment mode, or adjust other relevant aspects or configurations of the system.

[0133] Handle and tether Embodiments of the systems of the present invention further include a handle, which may be configured to operably connect to the console, e.g., via a tether, as described above. As described herein, in some embodiments, the handle or handle assembly includes a manifold assembly and / or oscillator, as described above. In some cases, the handle, e.g., its tether, includes a connector for connecting to, e.g., a console device. The connector may be configured for easy connection and disconnection, ensuring a safe and secure connection between the console and the handle. The connector may also be configured to provide feedback to the user indicating proper connection. This feedback may include an audible or visual signal, such as a click or light indicator, or a tactile signal, such as a vibration, indicating that the connectors are properly mated and the system is ready for use. In embodiments, any convenient connector may be used, e.g., a commercially available connector, such as a pneumatic connector, a hydraulic connector, an electrical connector, or an optical connector. In other embodiments, the handle may be operably connected to or include a manifold assembly or aspects of a manifold assembly, as described herein.

[0134] In embodiments in which the console includes a pneumatic system, the console's pneumatic system may be configured to maintain pressure without leaks, ensuring safe and effective delivery of the regulated gas. Such configuration may be achieved using O-ring seals, compression fittings, or other pneumatic sealing methods. The pneumatic system may be configured to be reliable and efficient, ensuring a steady supply of regulated gas without interruptions.

[0135] The electrical connector of the console may be configured to provide power and communication between the console and the handle, for example, via the tether (i.e., the handle may be powered by and communicate with the console via such electrical connector). Such a configuration may be achieved 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 configured to provide reliable and efficient power and communication, ensuring that the console and handle can effectively communicate, for example, via the tether, and that the console and / or handle and / or manifold assembly, if provided, can receive power as needed.

[0136] The console device and / or handle may be configured to detect when one or more connectors are disconnected from one another or otherwise form an open circuit. Such configuration may be achieved using physical interlocking mechanisms, pressure sensors, or other techniques. If a connector is disconnected, the console and / or handle may be configured such that the console immediately stops delivery of energy, such as delivery of regulated gas, and provides a visual or audible alarm to a user, i.e., operator, indicating that a connection has been lost. In such a case, the console and / or handle may also be configured to record the disconnection event and provide information to a user or external device via the electrical connector.

[0137] In embodiments, the handle, e.g., a tether aspect thereof, is configured to connect the console device to the handle. The tether may be configured to be flexible, durable, and reliable, allowing for easy maneuverability of the handle while maintaining a secure connection between the console and the handle and elements operably connected to the handle. The tether may vary, but in some cases has a length ranging from 10 inches to 20 feet, allowing for a wide range of movement and positioning of the handle. In embodiments, the tether typically has a length ranging from 10 inches to 20 feet, providing a wide range of movement and positioning for the handle, which in turn provides a wide range of movement and direction available for the atherectomy subsystem and pulsed endovascular disruption subsystem.

[0138] In embodiments, the tether includes two pneumatic lines, including a high-pressure intake hose and an exhaust hose, as well as a bend-and-stay wire and an electrical cable. The pneumatic hoses may be configured to carry or transmit regulated gas from the console to the handle, while the bend-and-stay wires may be configured to provide stability and support for the tether. The electrical cable provides power and communications, i.e., communication of data and / or control signals, between the console and the handle.

[0139] The tether may be assembled using methods that ensure a secure and reliable connection between the various elements. Such assembly may include crimping, welding, or other methods to secure the pneumatic hose and electrical cable in place. The tether may be further covered with a protective layer, such as a polyurethane or silicone coating, to protect against wear and tear and ensure the tether remains flexible and durable.

[0140] In embodiments, the handle may be configured to receive tether elements, including high-pressure intake hoses, exhaust hoses, bend-and-stay wires, and electrical cables. The handle may have several important functions, including controlling gas flow output and providing a physical connection point between the console and medical devices, i.e., the atherectomy subsystem, e.g., the atherectomy tool, and / or the pulsed endovascular disruption subsystem, e.g., the pulsed endovascular disruption catheter and / or distal balloon. The handle may be configured with a forward (i.e., distal) connector configured to physically receive a medical device connector (i.e., a connector connecting the handle to the atherectomy subsystem and / or the pulsed endovascular disruption subsystem), allowing the system to regulate gas, power, and communications supplied to the medical devices (i.e., the atherectomy subsystem and / or the pulsed endovascular disruption subsystem).

[0141] If desired, in handle embodiments, the handle may have one or more user interface features, such as buttons for user feedback, that allow a user (i.e., operator) to provide feedback regarding the status of the system. Such a handle can be used to start or end a treatment, adjust the intensity or duration of a treatment, for example, or adjust the type of treatment being applied, i.e., treatment via the atherectomy subsystem versus the pulsed endovascular spallation subsystem. The handle may also have LEDs, for example, to provide feedback to the user, allowing the operator to quickly and easily determine the status of the system.

[0142] The handle may have a pneumatic outlet that supplies regulated gas to the medical device (i.e., the atherectomy subsystem and / or the pulsed endovascular disruption subsystem). The handle may also have an electrical connection to a medical device connector to allow communication between the console and the medical device. The handle may be configured with strain relief at the back end (i.e., proximal end) to ensure that the connection remains secure when the handle is moved, handled, or otherwise manipulated during the procedure.

[0143] In addition to the physical elements, the handle may also include an electronic assembly (i.e., an electronic board, such as a printed circuit board) for controlling the treatment and receiving feedback. This electronic assembly may run a software program that determines the type, intensity, and duration of treatment, which may be preset based on sensor input or artificial intelligence, or adjusted by the user. The handle may be configured in either a handheld or tabletop configuration, and the length of the tether, for example, as described above, may vary between 10 inches and 20 feet, in some cases, depending on the particular needs of the medical facility.

[0144] In embodiments, the handle is operably connected to the atherectomy subsystem and the pulsed endovascular disruption subsystem. In some cases, the handle includes a single unit configured to house a switch, oscillator, or other aspect of the manifold assembly described above, and is configured to deliver energy to the pulsed endovascular disruption subsystem and the atherectomy subsystem. In embodiments, the handle is configured to be easily connected and disconnected from each of the pulsed endovascular disruption subsystem and the atherectomy subsystem. That is, in embodiments, a user of the system may first connect the atherectomy subsystem to the handle, perform an atherectomy procedure, and then disconnect the atherectomy subsystem and connect the pulsed endovascular disruption subsystem to perform the pulsed endovascular procedure; that is, one handle (and console and potential source) may be used with each of the atherectomy subsystem and the pulsed endovascular disruption subsystem.

[0145] In embodiments, the handle is configured to be held by an operator, for example, during use. Handles of interest may have any convenient shape, for example, a substantially cylindrical or substantially rectangular shape, and may have, for example, a height in the range of 10-100 cm, e.g., 20-30 cm, a width in the range of 5-100 cm, e.g., 10-20 cm, and a depth in the range of 10-100 cm, e.g., 20-30 cm, and a mass in the range of 1-20 kg, e.g., 5-8 kg. In embodiments, the handle has one or more tactile features to facilitate gripping the handle by hand, for example, with a gloved hand. Such tactile features may include grooves or indentations.

[0146] 4A is a schematic diagram of a handle 400 having a tether 450 according to an embodiment of the present invention. The handle tether assembly 450 includes a handheld body 410 and a tether 450. The handheld body 410 is located in a relatively distal region of the handle 400. The handle 400 includes a button 420 for receiving user feedback. The button 420 also includes an LED for providing feedback to the user, i.e., operator. The output connector 430 of the handheld body 410 of the handle 400 is located at a relatively distal end of the handle 400 and is configured to interface with each of the atherectomy subsystem and the pulsed endovascular disruption subsystem, i.e., when each of the atherectomy subsystem and the pulsed endovascular disruption subsystem is connected to the handle 400, regulated pressurized fluid, e.g., gas, is transmitted through the output connector 430 of the handle 400 to provide energy to each of the atherectomy subsystem and the pulsed endovascular disruption subsystem. The input connector 460 is located at a relatively proximal end of the tether 450 of the handle 400 and is configured to interface with a console, i.e., the input connector 460 is configured to receive pressurized fluid, e.g., gas, and power, e.g., electrical power, from the console via the input connector 460, and further includes an exhaust connection. The input connector 460 is further configured to transmit and receive electrical signals, including data and / or control signals.

[0147] As described, embodiments of the handle according to the present invention are configured to releasably engage with embodiments of the atherectomy subsystem connector and the pulsed endovascular disruption subsystem connector, such that either the atherectomy subsystem connector or the pulsed endovascular disruption subsystem connector can be operably connected to the handle. FIG. 4B shows a handle assembly 400 and connector 401 according to embodiments of the present invention. Connector 401 can be an atherectomy connector (e.g., connector 113 of atherectomy subsystem 160 or connector 213 of atherectomy subsystem 260) or a proximal connector (e.g., proximal connector 151 of pulsed endovascular subsystem 150 or proximal connector 251 of pulsed endovascular subsystem 250). In either case, the atherectomy subsystem connector and the pulsed endovascular disruption subsystem connector have the same proximal interface for interfacing with the distal interface of the handle. The connector and handle interface may include, for example, complementary shapes, operative connections (e.g., high-pressure fluid connections), electrical connectors, other interlocking mechanisms, etc., and such aspects may be identical between the atherectomy connector of the atherectomy subsystem and the proximal connector of the pulsed endovascular disruption subsystem. Figure 4B illustrates a general orientation of how the connector 401 may be operatively connected to the handle 400, i.e., the proximal interface of the connector 401 may abut the distal interface of the handle 400, the handle and connector may releasably engage to form an operative connection between the handle and connector, and how each of the atherectomy subsystem and the pulsed endovascular disruption subsystem may be interchangeably and operatively connected to the handle. Figure 4B further illustrates how the shapes, alignment features, latching features, and connectors of the handle 400 and connector 401 align when the handle 400 and connector 401 abut, i.e., are operatively connected to one another. Further details regarding the interface between the handle and connector embodiments are provided in US Patent Application No. 63545060.

[0148] Atherectomy Subsystem The atherectomy element (i.e., atherectomy subsystem) is a catheter-based system configured to remove plaque deposits within a blood vessel. The atherectomy element may be configured to perform any type of suitable atherectomy procedure. Atherectomy procedures of interest that may be performed by embodiments of the inventive system include, but are not limited to, excision atherectomy, laser ablation atherectomy, orbital atherectomy, and rotational atherectomy, or other means utilizing ultrasound, electrohydrolysis (EHL) cavitation emitters, and / or guidewire mechanotransduction to create holes through plaque deposits, such as chronic total occlusions.

[0149] In some cases, the atherectomy tool includes a rotational device, e.g., a rotational assembly, that converts the oscillator output (e.g., voltage, current, pressure, or flow) provided by the handle into rotational motion. This rotational motion is transmitted to a flexible drive shaft, e.g., a lateral transmission assembly, having both a proximal end and a distal end. A portion of the proximal end is attached to a rotational motor, and a portion of the distal end carries an abrasive burr. As the motor rotates, it transmits its rotational motion through the drive shaft to the attached abrasive burr. A guidewire can be passed through the drive shaft and the abrasive burr for stability. Additionally, an advancer can be provided to advance or retract the abrasive burr through the lesion. The atherectomy portion of the system can include multiple sensors, including current sensing, rotational position, velocity and / or acceleration sensing, heat and / or temperature sensing, linear position sensing, torque sensing, and pressure and / or flow sensing. In other cases, the atherectomy tool has a rotational device, e.g., a rotational assembly, that converts the output of a switch (e.g., voltage, current, pressure, or flow) provided, for example, by a handle and ultimately from a console, into rotational motion so that the atherectomy tool rotates and grinds through the lesion.

[0150] Rotational or orbital atherectomy tools / subsystems that may be components of the systems of the present invention include those disclosed in U.S. Pat. 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, 11,0 ... Nos. 65030, 10893882, 10729460, 10441311, 10405879, 10405878, 9084627, 9554823, and U.S. Patent Application Publication Nos. 2022 / 0387074, 2022 / 0240975, 2022 / 0142667, 2022 / 0133347, U.S. Patent No. Publication No. 2022 / 0133346, U.S. Patent Application Publication No. 2022 / 0061879, U.S. Patent Application Publication No. 2021 / 0322052, U.S. Patent Application Publication No. 2021 / 0251653, U.S. Patent Application Publication No. 2021 / 0145474, U.S. Patent Application Publication No. 2021 / 0077143, U.S. Patent Application Publication No. 2020 / 0397464, U.S. Patent Application Publication No. 2020 / 0397463, U.S. Patent Application Publication No. 2020 / 0315653, U.S. Patent Application Publication No. 2020 / 02 No. 29844, U.S. Patent Application Publication No. 2020 / 0222075, U.S. Patent Application Publication No. 2020 / 0214735, U.S. Patent Application Publication No. 2019 / 0365412, U.S. Patent Application Publication No. 2019 / 0343551, U.S. Patent Application Publication No. 2019 / 0307483, U.S. Patent Application Publication No. 2019 / 0262034, U.S. Patent Application Publication No. 2019 / 0262032, U.S. Patent Application Publication No. 2019 / 02602022, U.S. Patent Application Publication No. 2019 / 0201052,Examples of such patent applications include, but are not limited to, U.S. Patent Application Publication No. 2019 / 0201051, U.S. Patent Application Publication No. 2017 / 0135719, U.S. Patent Application Publication No. 2016 / 157886, U.S. Patent Application Publication No. 2016 / 0022307, U.S. Patent Application Publication No. 2014 / 0277010, U.S. Patent Application Publication No. 2014 / 0005699, and U.S. Patent Application Publication No. 2013 / 0086588.

[0151] In some embodiments, the atherectomy subsystem includes an atherectomy tool. Such an atherectomy tool may include a rotational atherectomy tool, an orbital atherectomy tool, a laser tool, an ultrasound tool, an electrohydraulic fragmentation (EHL) cavitation emitter tool, or one or more of a mechanotransduction tool. In embodiments, the atherectomy tool is located in a distal region of the system and may be configured to grind within a lesion. In some cases, the atherectomy tool is configured to traverse a lesion, such as an occluded lesion or a chronic total occlusion (CTO). In other cases, the atherectomy tool is configured to form a new channel within the occlusion. For example, the atherectomy tool may be configured to drill a hole within the occlusion. As described, the atherectomy tool may be a burr, such as an abrasive burr.

[0152] As described, the atherectomy subsystem may include a rotational assembly configured to generate rotational energy, such as a rotational motor. In embodiments, the rotational assembly is operably connected to the console or a potential source of the console, for example, via a handle and a tether. In embodiments, the rotational assembly is configured to convert energy transmitted from the console into rotational energy.

[0153] The atherectomy subsystem may further include a lateral transmission assembly configured to transmit rotational energy from the rotation assembly to the atherectomy tool. Such a lateral rotation assembly may be located distal to the rotation assembly and proximal to the atherectomy tool. In embodiments, the lateral transmission assembly includes a rotational drive shaft, such as a flexible drive shaft. The lateral transmission assembly may be configured to receive a guidewire, for example, via a guidewire lumen. Such a guidewire and guidewire lumen may include a fluid bearing of the atherectomy subsystem configured to dissipate heat, i.e., a fluid may reside within the guidewire lumen. The guidewire, if present, may be configured to provide stability to the lateral transmission assembly while transmitting rotational energy from the rotation assembly to the atherectomy tool. The guidewire, if present, may further be configured to include an atherectomy tool, where the atherectomy subsystem is configured to utilize guidewire mechanotransduction to drill through a lesion.

[0154] In some cases, the atherectomy subsystem includes an advancer configured to advance and retract the atherectomy tool distally and proximally toward and away from a lesion, e.g., a chronic total occlusion. The advancer may be configured to pulse the atherectomy tool in and out of the occluded lesion. Such advancer movement may utilize pulsed energy delivered from the handle. In embodiments, the atherectomy subsystem further includes a filter disposed distal to the atherectomy tool, the filter configured to protect the vasculature from distal emboli.

[0155] As described, embodiments of the atherectomy subsystem further include sensors, which may be configured to sense one or more of electrical current, rotational position, velocity, acceleration, temperature, linear position, torque, pressure, or flow. In embodiments, the sensors are configured to sense electrical current associated with the atherectomy subsystem in contact with an occluded lesion. That is, the sensors may sense a current response associated with the atherectomy subsystem penetrating a lesion, e.g., an occlusion containing calcified plaque.

[0156] Pulsed intravascular disruption subsystem The pulsed intravascular ablation subsystems of the systems of the present invention are configured to apply pulsed energy to calcified tissue, e.g., calcified vascular tissue. In embodiments, these subsystems may include a proximal connector configured to operably connect the balloon catheter assembly to a pulse generator and convert a first pulsed energy generated by the pulse generator into a second pulsed energy. In embodiments, the pulse generator may include a potential source, a console, and a handle, e.g., as described herein. The pulsed intravascular ablation subsystem further includes a distal balloon and a catheter element, the catheter element having a fluid passageway operably disposed between the proximal connector and the distal balloon, the fluid passageway configured to propagate the second pulsed energy from the proximal connector along the fluid passageway to the distal balloon.

[0157] As used herein, frequency refers to the number of total pressure pulse cycles (peak-to-peak) per unit time, duty cycle refers to the percentage of time allocated to the high-pressure segment of one pressure cycle, and amplitude refers to the difference between the maximum and minimum pressures. Because the energy delivered by the balloon to the internal tissue is pulsed, the energy varies (e.g., increases or decreases) at a defined or determined frequency and duty cycle. During pulsed intravascular ablation procedures, treatment time may be limited because blood flow distal to the distal balloon may be occluded. To successfully perform the procedure within this time, the pulse frequency and amplitude must deliver sufficient energy to the tissue to treat it. The frequency of the pulsed energy delivered by the balloon to the tissue associated with the balloon may vary; in some cases, the frequency is high frequency, in some cases within a range of 0-100 Hz, e.g., 0-25 Hz. Similarly, the duty cycle of the pulsed energy delivered by the balloon to the tissue may vary in some cases within a range of 10%-100%, e.g., 60%-80%. The amplitude of the pulsed energy delivered to the tissue by the balloon may optionally be varied within an internal balloon pressure range of 0-100 ATM, e.g., 0-30 ATM. In some cases, during a given treatment, the frequency may be varied over the course of the treatment, i.e., may not remain constant, as desired.

[0158] When applied to diseased luminal vascular tissue, pulsed energy is effective in treating diseased tissue, such as CP tissue, while reducing adverse effects on surrounding healthy tissue. Key characteristics of the pulsed energy for successful treatment may include the frequency and amplitude of the delivered pulsed energy. In embodiments, such pulsed energy may enable safe, controlled fatigue failure of the CP lesion. Fatigue failure is a process that cyclically loads a structure at pressures below those that result in instantaneous failure. While conventional treatments apply dangerous high-pressure bursts to the vessel, potentially causing dissection and perforation, pulsed endovascular laser ablation may use low-pressure, high-frequency vibrations within a balloon to initiate low-pressure fatigue failure of the CP lesion.

[0159] The described embodiments are dynamic physical systems whose output (e.g., actual frequency, duty cycle, and amplitude) is controlled by system inputs (e.g., desired frequency, duty cycle, and amplitude) and system characteristics (e.g., catheter length, friction, and channel lumen diameter). In system embodiments, the system is configured to generate controlled mechanical disruption pulses within an angioplasty balloon such that the system output follows a commanded or desired input signal, possibly with minimal attenuation. Signal attenuation is the reduction in amplitude of the system output relative to the input due to the characteristics of the physical system. For a successful procedure, minimal attenuation is required in that the output pulsed energy remains substantially similar to the input pulsed energy, e.g., in terms of frequency, duty cycle, and / or amplitude, as the pulsed energy 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 between the proximal connector and the distal balloon is, if at all, 30% or less, e.g., 5% or less. In some cases, any variation in the amplitude of the pulsed energy between the proximal connector and the distal balloon is 30% or less, e.g., 5% or less, if any. In some cases, any variation in the duty cycle of the pulsed energy between the proximal connector and the distal balloon is 30% or less, e.g., 5%, if any.

[0160] As summarized above, a pulsed intravascular ablation subsystem, representing a mechanical system according to an embodiment of the present invention, is operably connected to a pulse generator. In an embodiment, the pulse generator includes, for example, a potential source, a console, and a handle, as described herein. The pulse generator includes an element configured to generate a first pulsed energy that can be converted to a second pulsed energy by a proximal connector, as described in more detail below. The proximal connector is configured to receive the first pulsed energy provided by the pulse generator and convert it to a second pulsed energy that can be received by the distal balloon to provide the pulsed energy to an internal tissue location, for example, for use in DBA or pulsed intravascular ablation applications, and for use after final dilation of the vessel, for example, in a procedure that includes both applications. That is, embodiments of the present invention may be used to first apply pressure pulses to luminal tissue, such as a blood vessel, to create fissures in calcium (i.e., tissue affected by CP), and then dilate the vessel using a conventional non-compliant balloon after dilation. Considering embodiments of aspects of the pulsed intravascular ablation subsystem in more detail,

[0161] The first pulsed energy may be varied as desired; examples of the first pulsed energy include, but are not limited to, pulsed pressure energy, pulsed mechanical energy, pulsed electromagnetic energy, etc. Because the first pulsed energy is pulsed, the magnitude of the first energy varies or modulates over time, for example, according to a determined or known frequency, e.g., a predetermined frequency, according to the user, and / or according to the progress of the treatment. The frequency of the first pulsed energy may be varied, but in some cases, the frequency is high frequency, in some cases within a range of 0-100 Hz, e.g., 2-25 Hz. As described below, during a given treatment, the frequency, amplitude, and / or duty cycle may be varied, i.e., not remain constant, over the course of the treatment, as desired (e.g., as described in conjunction with FIG. 6 below). The frequency, amplitude, and / or duty cycle may also be varied depending on the type of catheter and distal balloon (e.g., balloon length and / or diameter, shaft length), type of procedure, lesion hardness, lesion density (e.g., as obtained by computed tomography or intravascular imaging), lesion morphology, etc. The frequency, amplitude, and / or duty cycle may also be varied depending on user input, negative feedback from measurements, and / or positive feedback from system modeling.

[0162] As described herein, the pulse generator of embodiments of the present invention includes a potential source configured to provide energy that may be adjusted as desired by a regulator and oscillator to provide the pulsed aspect of the first pulsed energy. Any convenient potential source may be used, and examples of potential sources include voltage sources, pressure sources, electromagnetic sources, electric field sources, chemical sources, laser sources, etc. In some embodiments, the potential source is a pressure source, and examples of suitable pressure sources include, but are not limited to, compressed gas cylinders, compressors, etc. If desired, the potential source may be operably coupled to a regulator, which functions to modulate the energy into an appropriate form that may be further acted upon by the oscillator. For example, if the potential source is a high-pressure gas source, such as may be used in a pneumatic pulse generator, the regulator may function to adjust the pressure of the gas to an appropriate value that can be input to the oscillator. In addition to the potential source and regulator, the pulse generator may include an oscillator. In such cases, the oscillator is used to modulate the magnitude and timing of the potential energy from the potential source to provide the desired first pulsed energy.

[0163] The different elements of the pulse generator may be provided within a single housing or may be provided as two or more separate, operably connected units. In some cases, at least some of the elements of the pulse generator are provided within a unit configured to be handheld, e.g., a handle. In such cases, the handheld element, e.g., the handle, is configured to be held and operated by one adult human hand. The form factor of such handheld units may vary as desired; in some cases, such units have a typical diameter and / or width in the range of 20-150 mm, e.g., 50-80 mm, a length in the range of 50-300 mm, e.g., 100-200 mm, and a mass in the range of 100-2000 g, e.g., 500-750 g. For example, the pulse generator may have a first console element, e.g., a console, as described herein, that houses or is operably connected to the potential source and houses a regulator, and a second handheld actuator, i.e., a handle, as described herein, that includes an oscillator and an actuator for the oscillator, e.g., an operable button. The handheld actuator may have electrical connectors for making electrical connections to various elements of the pulsed intravascular disruption subsystem, as desired, For example, the electrical connectors may be used to receive data regarding diaphragm position, memory, and / or pressure, and to provide power to these sensors, examples of which are described further herein.

[0164] In some cases, at least some of the pulse generator elements are provided in an attachable unit configured to be placed or secured on an operating table near the patient, so that a physician need not be physically present to treat the patient. In such cases, the attachable unit is configured to be easily clamped or secured to the operating table or independently stabilized and can be operated by a remote control unit. In such cases, the attachable unit may have a communicator that provides communication between the unit and a distal control unit; the communicator may be implemented with any desired hardware and / or software configuration and may be configured to communicate using wired or wireless (e.g., Bluetooth or radio frequency) protocols. Pulse generators used in the systems of the invention may be configured to be reusable or single-use, as desired. Pulse generators used in the systems of the invention may be configured to receive a sterile sleeve so that the pulse generator may be used without contaminating the sterile field of the operating room. Further details regarding pulse generators and their components, such as potential sources, oscillators, regulators, etc., that may be used in embodiments of the present invention are described in U.S. Pat. No. 1,464,949, U.S. Patent Application Publication No. 2020 / 0046949, pending International Application No. PCT / US2020 / 055458, and pending International Application No. PCT / US2022 / 014785, the disclosures of which are incorporated herein by reference.

[0165] As summarized above, the pulsed intravascular disruption 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 the first pulsed energy into a second pulsed energy, which may be transmitted along the length of the catheter, e.g., along a fluid, e.g., liquid, passageway of the catheter, to the distal balloon. When converting the first pulsed energy into the second pulsed energy, the proximal connector changes the form of the pulsed energy in some manner. Examples of changes in the form of energy that may be performed by the proximal connector include, but are not limited to, changing the pressure and / or flow rate of a gas to the pressure and / or flow rate of a liquid, changing mechanical potential and / or kinetic energy to the pressure and / or flow rate of a fluid, changing optical potential and / or kinetic energy to the pressure and / or flow rate of a fluid, changing electric field potential and / or kinetic energy to the pressure and / or flow rate of a fluid, changing magnetic potential and / or kinetic energy to the pressure and / or flow rate of a fluid, etc. For example, if the first pulsed energy is first pulsed pneumatic energy, the proximal connector may be configured to convert the first pulsed pneumatic energy to second pulsed hydraulic energy, which may be propagated from the proximal end to the distal end of the pulsed intravascular disruption subsystem, an example of converting pulsed energy from gas to liquid. In some cases, the pulsed intravascular disruption subsystem propagates the second pulsed energy from the proximal end to the distal end with little, if any, attenuation, and if there is attenuation, the magnitude of any attenuation does not exceed a 30% reduction, for example, as described above, and in some cases does not exceed 5%.

[0166] In some cases, the pulsed intravascular disruption subsystem includes (i) a proximal connector operatively connecting the pulsed intravascular disruption subsystem to a pulse generator and configured to convert first pulse energy generated by the pulse generator into second pulse energy, (ii) a distal balloon, and (iii) a catheter element including a fluid passageway operatively disposed between the proximal connector and the distal balloon.

[0167] The proximal connector is an element of the assembly located proximal to the pulsed intravascular disruption subsystem, e.g., at or near the proximal end, e.g., within 1 cm or more of the proximal end, and is configured to operably connect the pulsed intravascular disruption subsystem to a pulse generator, e.g., as described above, and convert a first pulsed energy into a second pulsed energy. The manner in which the proximal connector operably connects to the pulse generator (i.e., the manner in which the proximal connector operably connects to the handle) can vary as desired, and a given type of connector can be a press-fit connector, latch connector, screw connector, threaded connector, magnetic connector, push-together connector, yor-lock connector, claw clamp connector, gasket connector, socket connector, flanged connector, cam groove socket, quick connect connector, etc., and aligners or detents can be used as desired to achieve a connection that repeatedly and accurately aligns the proximal connector with the pressure generator and / or electrical connector. As described, such an operable connection between the proximal connector and the handle is configured to be the same operable connection as the connection used to connect the atherectomy subsystem connector to the handle. For example, both the proximal connector and the atherectomy subsystem connector may have the same shape and the same latching mechanism to hold such connector in place relative to the handle. That is, the system of the present invention utilizes a uniform interface for the atherectomy subsystem and the pulsed endovascular ablation subsystem so that each may be interchangeably and operably connected to the handle.

[0168] As discussed above, in some cases, the conversion is fluid-to-fluid energy conversion, e.g., the first pulsed energy is pulsed pneumatic energy and the second pulsed energy is pulsed hydraulic energy. In such cases, the proximal connector may have a proximal chamber and a distal chamber separated by a membrane, e.g., the membrane seals the distal chamber from the proximal chamber. The proximal chamber may be configured to receive pulsed pneumatic energy from a pulse generator. The volume of the proximal chamber may vary, in some cases, from 0.1 mL to 100 mL, e.g., from 1 mL to 4 mL, and in some cases, the proximal chamber is filled with a gas. In some cases, the proximal chamber forms a chamber with a minimum volume while still being large enough to accommodate the volume change required to fill the distal balloon. In this case, the time to fill this minimum volume chamber to a certain pressure is minimized, allowing for increased frequency of pulsed intravascular disruption procedures. The distal chamber is fluidly coupled to a fluid passageway of the catheter element. The volume of the distal chamber may optionally vary between 0.1 mL and 100 mL, for example between 1 mL and 4 mL, and optionally the distal chamber is filled with a liquid.

[0169] The membrane separating the proximal and distal chambers is configured to move in response to the first pulse of energy and, upon movement, generate a second pulse of energy within the distal chamber of the connector. The membrane may have a variety of dimensions, and in some cases, the membrane has an area of ​​100 mm 2 ~5000 mm 2 , e.g., 500 mm 2 ~2000 mm 2The membrane may be fabricated from any convenient elastic (e.g., flexible) material, and in some cases, the material has a hardness in the range of Shore 10A to Shore 90A, e.g., Shore 50A, and a thickness in the range of 0.5 mm to 5 mm, e.g., 1.0 mm to 2.5 mm. Examples of suitable membrane materials include, but are not limited to, silicone, rubber, and the like, and in some cases, may be strengthened by adding a reinforcing element such as braiding. If desired, a biasing element such as a spring may be provided for a default or baseline position of the membrane. For example, a spring may be provided on the distal chamber side of the membrane, which biases the membrane back to its initial position when force is removed from the proximal chamber side of the membrane. In other cases, the system may be controlled so that the pulse generator applies a constant pressure (but low, e.g., 0.1 to 2 atm) to the proximal chamber to counter the priming pressure. This counterforce allows the diaphragm to be positioned appropriately to initiate the pulsed intravascular lysis procedure and begin measurements.

[0170] The configuration of the proximal connector of embodiments may vary, but in some cases, the proximal chamber may be defined by a proximal flange, the distal chamber may be defined by a distal flange, the proximal and distal flanges may be disposed on opposite sides of a membrane to define the proximal and distal chambers, and the proximal and distal chambers may be sealed (e.g., hermetically sealed) from one another by a separating membrane. In such cases, the proximal flange may have a proximal port perpendicular (e.g., axial) to the proximal flange that is configured to receive a first pulse of energy, e.g., pulsed pneumatic energy, generated by the pulse generator. The dimensions of the proximal port may vary as desired, and in some cases, the port has an outer diameter in the range of 1 mm to 30 mm, e.g., 3 mm to 8 mm, and an inner diameter in the range of 1 mm to 30 mm, e.g., 2 mm to 7 mm. In such cases where the proximal flange has a proximal port, the length of the proximal port may be in the range of 1 mm to 50 mm, e.g., 3 mm to 10 mm. In such cases, the distal flange may have a distal port that fluidly couples the distal chamber with the fluid passageway of the catheter. The dimensions of the distal port may vary as desired, and in some cases the lumen diameter of the distal port may be in the range of 0.1 mm to 10 mm, e.g., 1 mm to 3 mm.

[0171] When the proximal chamber has a proximal port, the proximal chamber is fluidly coupled to the port. In such cases, the junction between the proximal port and the proximal chamber may have a nozzle and / or diffuser, which may be geometrically formed by a proximal flange. In such cases, the nozzle or diffuser may act to increase or decrease the flow rate at the expense of fluid pressure. Such an increase or decrease in flow rate may improve the characteristics of energy conversion, such as rise time or smoothness of energy conversion. In the case of airflow, the gas velocity may be high enough to induce compressible fluid phenomena, such as sonic or supersonic flow. In such cases, specialized flow nozzles, such as converging-diverging nozzles, may be used to optimize the flow rate.

[0172] If desired, the proximal connector may include one or more sensors configured to provide data regarding, for example, one or more elements of the connector and / or balloon catheter assembly. Any convenient 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 cases, the proximal connector includes a pressure sensor operably coupled to the distal chamber. In such cases, the pressure sensor may detect pressure and pressure changes of the fluid in the distal chamber. If a pressure sensor is included, any convenient type of pressure sensor may be provided, and examples of pressure sensors that may be provided include, but are not limited to, resistive sensors, capacitive sensors, piezoelectric sensors, optical sensors, and MEMS-based pressure sensors. In some cases, these pressure sensors may measure pressure at the proximal connector; in other cases, pressure may be read at or along the length of the catheter and / or distal balloon. For example, a fiber optic-based sensor may be used to measure such pressure at the distal balloon. In some cases, the proximal connector includes a membrane position sensor configured to provide spatial data regarding the position of the membrane at a given time, e.g., during use of the subsystem. If a membrane position sensor is provided, any convenient membrane position sensor may be used. In some cases, the membrane position sensor is a Hall sensor, and the Hall sensor may be used in conjunction with one or more magnets (e.g., permanent magnets or electromagnets) that are provided in a fixed position relative to the membrane, e.g., in a fixed position on the proximal connector, such that, for example, the one or more fixed magnets are arranged to modulate the voltage of the Hall sensor upon movement of the membrane. In other cases, the membrane position sensor may be an optical sensor, a field potential sensor, a resistive sensor, a magnetic sensor, an angle sensor, or an acceleration sensor. Furthermore, any combination of these sensors may be used to collect membrane or diaphragm position data.For example, if a combination of membrane position sensors is used to ensure the sensors provide accurate data across a variety of frequencies, the sensor data may be combined using "sensor fusion" techniques as known in the art. When present, membrane position sensors may be used for a variety of different purposes, such as to assess vessel compliance and treatment (as described below), to assess proper filling of the proximal connector, catheter, and / or distal balloon, to provide a method for assessing whether the membrane has stretched beyond a desired threshold, etc. Fabrication methods for membrane sensors may include, but are not limited to, adhesives, direct printing, welding, embedding, etc.

[0173] If desired, the proximal connector may further include an electrical assembly. The electrical assembly may be configured to perform multiple 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, and writing and / or reading data. The electrical assembly may vary and, in some cases, include circuitry and / or memory. If present, the memory may store a variety of 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, batch number, balloon size (e.g., balloon diameter and length), rated burst pressure and nominal pressure of the balloon, cycle limits (e.g., rated allowable number of cycles for the balloon), and cycles used, allowable pulse frequency or duration, previous use, balloon baseline pressure-volume curve, and / or instructions for use. If present, the electrical assembly may further include a connector, for example, for operably connecting the electrical assembly to a pulse generator. The electrical assembly may be provided in any convenient configuration, such as a printed circuit board, including a flexible printed circuit board. In some cases, the sensor may transmit data wirelessly, such as via Bluetooth RF.

[0174] For example, various elements of the proximal connector as described above may be provided within a housing or overmold configured to protect the elements of the proximal connector, for example, during accidental dropping or packaging. The housing, if provided, may be fabricated from a suitable rigid material, for example, a polymeric material, and may be transparent or opaque as desired.

[0175] As summarized above, the pulsed intravascular disruption subsystem may include a catheter element disposed between the proximal connector and the distal balloon. The catheter element is configured to propagate or transmit the second pulse of energy from the proximal connector to the distal balloon, e.g., with minimal, if any, attenuation, as described above. The catheter element has a portion, e.g., a shaft, configured for use as a catheter so that it may be introduced into a lumen of a human or another animal, e.g., a mammal. The dimensions of this portion may vary, and in some cases, the outer diameter (OD) of this catheter portion is in the range of 1.50 mm to 2.50 mm, e.g., 1.75 mm to 2.20 mm.

[0176] The catheter element may have a variety of configurations, including a proximal flexible tube, a distal catheter shaft (e.g., a catheter portion as described above), and a connector connecting the distal end of the proximal flexible tube to the proximal end of the distal catheter shaft. The proximal flexible tube is formed of a flexible material, such as braided or non-braided polyvinyl chloride (PVC), silicone, or polycarbonate (PC), and the dimensions of the proximal flexible tube may vary. In some cases, the proximal flexible tube has a lumen with a diameter ranging from 0.1 mm to 10 mm, e.g., from 1 mm to 3 mm, and a wall thickness ranging from 0.1 mm to 5 mm, e.g., from 0.5 mm to 2 mm. The length of the proximal flexible tube may also vary, and in some cases may be between 1 cm and 100 cm, e.g., between 5 cm and 20 cm.

[0177] The distal catheter shaft may also vary. The distal catheter shaft may be made of any suitable physiologically acceptable material, including, but not limited to, polyimide, such as polyimide braid, or a polyimide-type material. In some cases, the length of the distal catheter shaft may range from 10 cm to 5 m, e.g., 100 cm to 300 cm. The outer diameter of the distal catheter shaft may also vary, in some cases ranging from 1.50 mm to 2.50 mm, e.g., 1.75 mm to 2.20 mm. The distal catheter shaft may have a first fluid passage lumen, and the dimensions of this first fluid passage lumen may vary. In some cases, the diameter of this first fluid passage lumen is in the range of 1.3 mm to 2.2 mm, e.g., 1.6 mm to 2.1 mm. The first fluid passage may have one or more openings at its distal end for establishing fluid communication between the interior of the fluid passage lumen and the interior of the distal balloon. The one or more openings, if present, are configured to substantially not attenuate, and in some cases not attenuate at all, the second pulsed energy as it enters the balloon from the fluid passage. In some cases, these openings may be configured as nozzles and / or diffusers. In such cases, the nozzles or diffusers may act to increase or decrease the flow rate at the expense of fluid pressure. Such an increase or decrease in flow rate may alter the balloon expansion characteristics, such as rise time, impulse, and force. The distal catheter shaft may further include a second guidewire lumen. If a second guidewire lumen is present, the dimensions of this second guidewire lumen may vary; in some cases, the diameter of the guidewire lumen is within the range of 0.25-0.5 mm, e.g., 0.37-0.42 mm. The distal catheter shaft may be configured to traverse the entire length of the distal balloon or terminate at the proximal connection portion of the distal balloon. If the distal catheter shaft spans the entire length of the balloon, the distal catheter shaft may be provided with a port to allow fluid communication between the interior of the distal catheter shaft and the distal balloon. The port may be formed using laser machining or other specialized machining processes.The pattern or distribution of ports on the catheter shaft can be arranged to ensure that the distal catheter shaft has the necessary stiffness to navigate narrow, calcified lesions and prevent kinking, yet flexibility to traverse long, tortuous lesions. The diameter of the port holes can range from 0.05 to 1 mm, for example, 0.2 mm. The holes can be formed in a helical or linear pattern, or along the internal braid of the material. The number of holes can range from 100 to 500, for example, 200. The total area of ​​the holes should exceed the cross-sectional area of ​​the flow passage lumen. By forming 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 pulsed energy during the procedure. This configuration ensures that when one portion of the balloon is deflated, that portion and the other portions of the balloon receive an equal amount of energy. The disadvantage of this configuration is that the cross-sectional profile (i.e., the overall diameter of the distal catheter shaft) is larger, making it more difficult to pass through narrow lesions or the narrow, perforated volumes associated with atherectomy procedures. To narrow the distal catheter shaft, the distal catheter shaft may terminate at the proximal balloon junction. In this case, only the guidewire lumen traverses the length of the balloon. The balloon may have a proximal neck diameter that matches the distal catheter shaft and a distal neck diameter that matches the guidewire lumen. Because the guidewire lumen has a smaller diameter than the distal catheter shaft, the transverse profile of this configuration may be improved compared to, for example, the previously described configuration. However, because there is only one port for delivering fluid from the distal catheter shaft to the balloon, this may result in uneven energy distribution at the balloon wall and calcified lesions. These two configurations may be used for different indications, anatomical locations, etc.

[0178] The catheter element of these embodiments further includes a connector connecting the distal end of the proximal flexible tube to the proximal end of the distal catheter shaft. The connector may vary as desired. In some cases, the connector has a first branch configured to provide guidewire access to the guidewire channel of the catheter shaft and a second branch configured to fluidly couple the lumen of the proximal flexible tube and the fluid passage lumen of the distal catheter shaft. Examples of suitable connectors include a Y-connector or similar connector, which in some embodiments have a sufficient number of ports through which the lateral transmission assembly of the atherectomy subsystem may be coupled to the catheter of the pulsed endovascular ablation subsystem. In such embodiments, the catheter of the pulsed endovascular ablation subsystem may have one or more channels, e.g., lumens, to accommodate aspects of the lateral transmission assembly of the atherectomy subsystem. For example, the catheter may have a channel or lumen to accommodate a guidewire operably connected to the rotation assembly and the atherectomy tool. For example, such a configuration may include a fluid bearing for the lateral transmission assembly of the atherectomy subsystem.

[0179] As discussed above, the pulsed intravascular disruption subsystem further includes a distal balloon. Any convenient balloon may be used. Suitable balloons include, but are not limited to, standard angioplasty balloons, such as compliant angioplasty balloons and non-compliant angioplasty balloons. In one embodiment, the balloon is a composite balloon including two distinct layers, including a non-compliant layer and a compliant layer. To describe the improvements of the current composite balloon design over the prior art, the two layers of the composite balloon are described as individual units. Non-compliant angioplasty balloons are typically used in percutaneous procedures because their set diameter allows them to distribute force evenly to the surrounding vessel without inflating into the less stiff healthy tissue surrounding the stenosis. When the material of the non-compliant balloon is pressurized, the non-compliant balloon fills first, creating a low-pressure, high-distensibility state. Once the non-compliant balloon reaches its nominal diameter, the pressure in the non-compliant balloon increases significantly, and the distensibility rate decreases accordingly. When pressure within a non-compliant balloon is released, it remains at its nominal distension rate due to its lack of elasticity. This lack of elasticity is problematic for three reasons: (1) Unless a vacuum is created, the deflated balloon remains filled, potentially occluding blood flow; (2) After the procedure, it can be difficult to remove the balloon catheter through the sheath; and (3) During pulsed procedures, the balloon does not expel fluid during the low-pressure phase, preventing necessary stress relaxation in the surrounding tissue. Thus, while non-compliant balloons are useful at high pressures, they are limited at lower pressures. Compliant angioplasty balloons typically have a linear pressure-distension curve. The use of these balloons is limited in percutaneous procedures because the balloon may distend unevenly around the hardened portion of the artery, potentially causing damage to the healthy soft tissue surrounding the hardened, diseased tissue. With a compliant balloon, the balloon pressure typically increases linearly. Compared to a non-compliant balloon, a compliant balloon has a "short" initial fill region, so that when pressure within the compliant balloon is released, the compliant balloon returns to its initial distended state without the need for additional vacuum.Returning to the initial distended state is beneficial for pulsed angioplasty procedures because it immediately restores blood flow and allows the balloon to be more easily retracted through the sheath. Furthermore, during pulsed angioplasty, balloon compliance is necessary to act as a driving force to expel fluid from the balloon and allow the surrounding tissue to relax with less stress during the low-pressure phase. Thus, while compliant balloons are useful at lower pressures, they limit their ability to perform procedures at higher pressures. Non-compliant and compliant angioplasty balloons alone are not optimal for the various phases of pulsed and standard percutaneous transluminal angioplasty. However, when used together as a composite, non-compliant and compliant angioplasty balloons can fulfill important needs for both procedures. In one embodiment of a composite angioplasty balloon, a non-compliant balloon is covered with a compliant sleeve to achieve an "arrow-like" pressure-distension, as further described, for example, in pending International Application No. PCT / US2020 / 055458, the disclosure of which is incorporated herein by reference. The compliant layer may be a rubber, silicone, polyurethane, nitinol, or another material that can stretch 100-500% before failure, can withstand thousands of cycles before failure, and minimizes, if any, plastic deformation during expansion. During use, the exemplary composite balloon functions as follows: During the low-pressure phase, the compliant material dominates the response. The composite balloon follows the curve of the compliant material until the composite balloon's distension intersects with that of the non-compliant balloon. At this intersection and higher pressures, the non-compliant material dominates the balloon response. Upon pressure release, the balloon returns along the arrow-like response to its initial or zero distension state. 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, with other advantages including automatic folding and deflating of the balloon, reduced tearing and pinholes, increased vibration frequency during pulsed angioplasty, and an improved ability to withstand being pushed or otherwise compressed in directions such as longitudinally while the balloon is traversing a lesion.Further details regarding composite angioplasty balloons and the like used in embodiments of the present invention may be found in U.S. Pat. No. 1,464,949, U.S. Patent Application Publication No. 2020 / 0046949, pending International Application No. PCT / US2020 / 055458, and pending International Application No. PCT / US2022 / 014785, the disclosures of which are incorporated herein by reference.

[0180] In other cases, the balloon may have external features that create pulse-like stress concentrations in the surrounding material. These features may be incorporated into the general balloon shape (i.e., the balloon assumes its original shape when pressurized) or may be incorporated via additional elements (e.g., strips or cages) around the balloon. In some cases, the additional elements traverse the length of the balloon (i.e., from the proximal to the distal end of the balloon). In this case, stress concentrations are created in the surrounding material such that radial fractures occur in the calcium structure. In other cases, the additional elements traverse circumferentially around the balloon such that longitudinal fractures occur in the calcium structure as the balloon stretches during each pulse. Furthermore, the additional elements may be distributed orthogonally to create both radial and longitudinal stress concentrations in the surrounding material. Thus, both longitudinal and radial fractures can occur to completely fracture the calcium.

[0181] The pulsed intravascular disruption subsystem may or may not be "sealed." In some cases, the pulsed intravascular disruption subsystem is not sealed, such that during use, a fluid, e.g., a liquid, may be introduced into one or more liquid passages of the assembly and / or gas may be removed from the subsystem (e.g., by debubbling). In still other cases, the pulsed intravascular disruption subsystem is a sealed or closed assembly, such that the liquid passages and distal balloon are pre-filled with liquid prior to use, sealing the liquid within the assembly. In either case, the liquid introduced into one or more lumens and the distal balloon may vary; in some cases, the liquid is saline. If desired, the liquid may include a suitable contrast agent, examples of which include, but are not limited to, radiocontrast agents, such as, but not limited to, iodine contrast agents, barium contrast agents, etc.

[0182] In some cases, the above-described embodiments may be configured so that the pulsed intravascular spallation procedure may be performed fully autonomously and / or remotely. In these cases, the catheter and distal balloon may be inserted into the patient manually or using a robotic catheter placement system (such as that described in International Publication No. WO 2010 / 025338, the disclosure of which is incorporated herein by reference). Using such a subsystem, devices such as a guidewire, catheter, and distal balloon may be advanced to the lesion site, and the distal balloon may be inflated or deflated once the lesion site is reached. In the embodiments described above, the balloon may be pre-filled with fluid so that the user does not need to fill the balloon before pressurization. In other cases, composite balloon embodiments may be used to ensure that the balloon is deflated and rolled up after the procedure so that the composite balloon may be easily removed. In such cases, an operator may be present at the console to control the procedure, including pressure, frequency, and / or duty cycle. Simultaneously, the operator may be able to view an X-ray image to simultaneously visualize the inflated balloon and the effectiveness of the procedure. In some cases, feedback, e.g., visual, audio, tactile, etc., may be provided to the operator to indicate characteristics of the treatment, such as volume and / or pressure changes in the balloon, frequency, duty cycle, balloon expansion, balloon position, etc.

[0183] The pulsed intravascular disruption subsystem may be configured for single use, i.e., one-time use, so as to be disposable. Prior to use, the pulsed intravascular disruption subsystem may be sterilized, if desired.

[0184] Further details regarding aspects of or elements related to the systems of the present invention, including consoles, regulators, potential sources, handles, manifold assemblies, oscillators, pulse generators, balloon catheter assemblies, atherectomy subsystems, pulsed endovascular disruption subsystems, distal balloons, composite angioplasty balloons, and the like, which may be incorporated into or used in conjunction with embodiments of the present invention, can be found in U.S. Pat. No. 1,464,949; U.S. Patent Application Publication No. 2020 / 0046949; U.S. Patent Application No. 1,789,760; the disclosures of each of which are incorporated herein by reference. 4, pending International Application No. PCT / US2019 / 027139, pending International Application No. PCT / US2020 / 055458, U.S. Application No. 63274832, U.S. Application No. 17827169, pending International Application No. PCT / US2022 / 014785, U.S. Application No. 63238381, pending International Application No. PCT / US2022 / 040586, U.S. Application No. 63346703, pending International Application No. PCT / US23 / 23533, U.S. Application No. 63346704, pending International Application No. PCT / US23 / 22685, U.S. Application No. 63444414, and U.S. Application No. 63545060.

[0185] Some additional features Some embodiments of the present system include an internal guidewire lumen disposed within a pulsed intravascular ablation catheter (e.g., guidewire 257 disposed within the guidewire lumen of catheter 254 in FIG. 2B). Such embodiments may be configured to allow for low-friction rotation of the guidewire even at high speeds, i.e., high frequency rotations. An example technique involves the use of a fluid bearing (e.g., using a pressurized fluid, such as saline, contrast agent, or other lubricant) to provide fluid within such a guidewire lumen. In embodiments, such a fluid bearing may further function to dissipate heat generated by the rotation of the guidewire within the catheter's guidewire lumen. Another technique involves the use of a self-lubricating material on the inner surface of the catheter's guidewire lumen.

[0186] If desired, to prevent winding or lashing of aspects of the system during atherectomy grinding, i.e., while the atherectomy tool is rotated via the lateral transmission assembly with the guidewire (i.e., while the atherectomy tool 269 is rotated by rotation of the guidewire 257), a Y-hub or similar hub (e.g., connection 258 in FIG. 2B) of the pulsed intravascular disruption catheter may be connected to the atherectomy subsystem, e.g., ultimately to the atherectomy tool.

[0187] If desired, the gas used to power the atherectomy subsystem and / or pulsed endovascular disruption subsystem can be vented back to the console, e.g., from a switch located within the system. Such a configuration may help ensure, for example, that the gas is vented to a desired volume and does not enter the sterile field. This vent gas path may be achieved, for example, by including exhaust tubing within the handle and / or tether and / or the atherectomy subsystem and / or pulsed endovascular disruption subsystem.

[0188] In embodiments, the atherectomy subsystem utilizes rotational motion to drill or grind the lesion by rotating or orbiting the atherectomy tool. In some cases, such rotational motion is generated by compressed gas turning a turbine. Such a turbine may be operatively connected to a lateral transmission assembly, for example, carrying a guidewire. In other cases, such rotational motion is generated by a motor and motor control, e.g., an electromagnetic motor. The motor, if provided, may be located in the atherectomy subsystem, handle, console, or another aspect of the system embodiment. The motor control may be located in any of these locations, but need not be directly adjacent to the motor. The motor, if provided, may be directly connected to the lateral transmission assembly or its guidewire. Alternatively, the motor may be connected to the lateral transmission assembly or its guidewire, which may be coupled to the atherectomy subsystem via a rotor connection or gear set. That is, the lateral transmission assembly may have gearing or other techniques to adjust or regulate the rotation of the drive shaft so that the atherectomy tool rotates as desired.

[0189] Embodiments of the systems of the invention may be provided with one or more sensors configured to determine an aspect of rotation of the lateral transmission assembly and / or the atherectomy tool, such as the rotation of a guidewire operably connected to the grinding burr. Sensors of interest include optical rotation sensors; a flow meter operably connected to the rotating assembly, e.g., a motor, e.g., operably connected to the outlet of the turbine of the rotating assembly; a current sensor on the rotating assembly, e.g., on a motor (i.e., generator) attached to the outlet of the rotating assembly; a Hall sensor configured to sense the distance of an aspect of the atherectomy subsystem, e.g., the position of the atherectomy tool or the lateral transmission assembly; etc.

[0190] Embodiments may be further configured to ascertain compliance measurements before, during, or after treatment with the pulsed intravascular disruption subsystem. Such compliance measurements may be generated by combining treatment with the atherectomy subsystem with pre- and post-treatment compliance measurements with pulsed intravascular disruption therapy.

[0191] method The systems of the present invention have a variety of uses. In some cases, the systems are used to fracture hardened material embedded within elastic conduits. For the embodiments presented herein, the disclosure describes applications related to the treatment of atherosclerotic calcification in arterial conduits, such as coronary or peripheral arteries. However, the systems and teachings are not limited to atherosclerotic calcification or arterial conduits alone and may be generally applicable to other applications as determined by one skilled in the art. For example, this is particularly true in situations involving medical interventions that alter arterial compliance (arterial vascular compliance as described herein) or where a subsequent occlusion occurs due to the prior presence of a stent. Vascular compliance changes with the intraluminal placement of a previous stent. Data and feedback on the vascular compliance curves can be used in connection with future treatments and for predictive techniques, such as the machine learning techniques described herein.

[0192] In some cases, various embodiments of the systems described herein are used in pulsed endovascular ablation, a technique that uses pressure oscillations with a generalized waveform (in some embodiments, harmonic or frequency-specific pressure waveform oscillations) to effectively and safely disrupt calcified lesions during angioplasty. After a system has been used to perform an atherectomy procedure, such a system may be used in a pulsed endovascular ablation method, which allows aspects of the pulsed endovascular ablation subsystem to access the lesion by puncturing or abrading the lesion. The concept of DBA for treating calcified arterial plaque is illustrated in Figures 5A-5E. In DBA, a catheter 516 having a balloon 502 is deployed into a blood vessel 500 containing calcified deposits 550 (Figure 5B), for example, using a guidewire using any convenient protocol known in the art.

[0193] In embodiments of the invention, the atherectomy subsystem of the system is first used to create or dilate a pathway through the occlusion 550. In such cases, an atherectomy tool may be utilized to create or dilate a pathway through the occlusion 550. As described herein, the atherectomy tool may have an abrasive burr such that the atherectomy tool rotates to abrade aspects of the lesion 550, allowing the balloon 502 to access the vessel 500 through the lesion 550. In embodiments of the invention systems that include a composite tool, the atherectomy tool may be operably connected to the balloon 502, e.g., positioned distal to the balloon 502; for example, such elements may be connected via a guidewire.

[0194] The plaque is subjected to high-frequency pressure oscillations through the angioplasty balloon (Figures 5C-5D). During the low-pressure phase of oscillation (Figure 5C), the balloon pressure drops to near the minimum pressure required to achieve balloon inflation (typically 1-2 atm). During the high-pressure phase of oscillation (Figure 5D), the balloon is inflated to a peak pressure, which can be set by an operator, e.g., a physician, or automatically determined and set by the system. Typical peak inflation pressures may exceed the low-pressure range and be up to the balloon's maximum rated pressure, which may be 25 atm or higher. Such balloon pressure cycling imposes cyclic loading on the calcified plaque 550, which is below the plaque's burst stress but is in the plastic deformation zone. The internal heterogeneity of the calcified plaque is composed of many microfractures with sharp corners. Due to the spallation mechanism described herein, the cyclic loading shown in Figures 5A-5E generates cyclic stresses at these sharp corners near the plaque microfractures and irregular surfaces. Cyclic stress creates and grows these sharp corners, expanding microfractures into larger macrofractures. The growth of these microfractures results in more complete plaque fragmentation at lower inflation pressures compared to static pressures. It is predicted that the effectiveness of this fracture growth mechanism increases with increasing frequency of pressure cycles and the pressure differential between cycles. By generating controlled, high-frequency pressure cycles within angioplasty balloons, DBA reduces the balloon pressure required to fracture calcified plaque (e.g., by 1-50%, e.g., 20-30%, in some cases compared to suitable non-DBA controls), improves stent deployment, improves and controls drug delivery in drug-coated balloons, relieves stress on soft, lipid-core atherosclerotic plaque, dilates calcified in-stent restenosis, fractures calcified deposits on diseased cardiac valve leaflets, and improves balloon-based dilatation and deployment of prostheses and devices.Further details regarding embodiments of DBA methods in which the systems described herein may be used are provided in U.S. Pat. No. 11,464,949, U.S. Patent Application Publication No. 2020 / 0046949, pending International Application No. PCT / US2020 / 055458, and pending International Application No. PCT / US2022 / 014785, the disclosures of which are incorporated herein by reference.

[0195] In some cases, the system of the present invention, as described above, may be used in a sufficient manner to achieve a four-part pulsed treatment plan, as shown in FIG. 6, which provides safe and controlled expansion of the CP and surrounding healthy soft tissue. To treat these multi-component vessels, a four-part treatment algorithm may be used, including: (1) a low-stress soft tissue expansion phase 680 via the Mullins effect; (2) a plastic deformation phase 670 in the calcified plaque until plaque fractures; (3) an immediate pressure reduction phase 660 to detect plaque fracture and reduce surrounding tissue stress; and (4) a low-stress soft tissue expansion phase 635 via the Mullins effect to expand the soft tissue after calcium fractures. An embodiment of this four-part algorithm applying force to the vessel over time is shown in FIG. 6. Due to significant attenuation throughout the catheter and the lack of pressure control in prior art approaches, the input pressure to the catheter is not properly transmitted to the balloon (system output). Thus, tissue stress in prior art systems does not return to a low state during high-frequency oscillations (i.e., there is no tissue relaxation period), limiting the effectiveness of Mullins stress cycles. With damping minimization and pressure control, embodiments of the present system produce pressure oscillations in the distal balloon (system output) that track pressure input from a proximal source, with pressure oscillations ranging from 0 to 50 ATM, frequencies ranging from 0 to 25 Hz, and duty cycles ranging from 60 to 80%. This advance is significant for two reasons: (1) it allows the tissue to relax during the decompression cycles (in accordance with the Mullins effect), and (2) it allows sufficient oscillations to be applied to the vessel within the limited time that the artery is occluded during the procedure. Further details regarding how embodiments of the present invention may be used are provided in U.S. Pat. No. 1,464,949, U.S. Patent Application Publication No. 2020 / 0046949, pending International Application No. PCT / US2020 / 055458, and pending International Application No. PCT / US2022 / 014785, the disclosures of which are incorporated herein by reference.

[0196] In some cases, embodiments of the present invention may be applied to assess vascular compliance. Blood vessels are inherently compliant and elastic structures. Vascular compliance is necessary to convert pulsatile flow from the heart into steady flow within capillaries. However, over time, aging and the process of atherosclerosis can decrease vascular compliance, reduce luminal area, create flow mismatches, and place additional stress on the vasculature. Vascular compliance is particularly reduced during and after the formation of intimal and medial calcified plaques in the vessel wall.

[0197] Improving vascular compliance is a prerequisite for more definitive treatment of atherosclerosis. 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. See http: / / www.ncbi.nlm.nih.gov / pubmed / 25091093. To maximize vessel wall compliance after calcium buildup, angioplasty or pulsed intravascular tribolithography treatment can be used to disrupt the intimal and medial calcium rings, exposing more elastic elements of the tubular vessel and freeing them from mummified calcium. As described above, after an atherectomy procedure is performed using the atherectomy subsystem to access the lesion in either case, embodiments of the present invention may be used to apply pulsed endovascular ablation, which allows for both creating a fissure in the calcium (i.e., creating a fissure in the CP tissue as shown in FIGS. 5A-5E ) and applying a final post-dilation of the vessel. In some cases, embodiments of the present invention may achieve both fissure creation in the CP tissue and a final post-dilation of the tissue in a single procedure. That is, embodiments of the present invention may also be used to first apply DBA to pulse the vessel to create a fissure in the CP tissue, and then dilate the vessel using, for example, a conventional non-compliant balloon post-dilation.

[0198] By vascular compliance is meant a measurable quantity defined by the following relationship: C=△V / △P where ΔV is the change in volume of the vessel for a given change in pressure ΔP. Due to the incompressibility of tissue, vessel volume can be converted to area by dividing by the length of the vessel. Because the relationship between pressure and volume in arteries is nonlinear, distensibility is often determined at a given pressure or volume.

[0199] Obtaining vascular compliance can be challenging because simultaneous in vivo measurement of pressure change ΔP and vascular cross-sectional area change ΔA or volume change ΔV can be difficult. The system of the present invention, as described below, is used to address this challenge by accurately assessing vascular compliance in vivo.

[0200] As discussed above, the proximal connector of the pulsed intravascular disruption subsystem may include a membrane position sensor, such as a Hall sensor, that provides data regarding the spatial position of the membrane at any given time, and a pressure gauge for measuring the pressure within the fluid passageway and distal balloon of the balloon catheter assembly. In such a case, the system may be used to assess the volumetric expansion of the balloon in real time and / or assess the compliance of the vessel at the location of the balloon.

[0201] As a result of measuring the diaphragm position, changes in volume within the distal balloon can be assessed in real time, and the corresponding balloon pressure can be measured. That is, the system is configured to pressurize the distal balloon while simultaneously reading the pressure and volume within the pulsed endovascular disruption subsystem. As described above, because vessel compliance is the ratio of changes in vessel volume to changes in pressure, this pressure-volume relationship can provide a measure of vessel compliance. To enable this measurement, the relationship between balloon volume and pressure can be measured when the distal balloon is unhindered by the surrounding vessel. When placed within a stiff vessel, the balloon requires higher pressure for an equivalent balloon volume in an unhindered baseline state. Thus, the balloon may be used to measure vessel compliance. Because diaphragm position (a surrogate measure of balloon volume) and balloon pressure are accurately recorded, vessel compliance can be easily measured in vivo. This compliance measure can be used as a measure of procedural success, with lower compliance indicating adequate or therapeutic balloon dilation and procedural success. In some cases, the system is used in a manner similar to that described in U.S. Patent Application Publication No. 2015 / 0080747 (the disclosure of which is incorporated herein by reference), which uses membrane displacement as a measure of balloon volume.

[0202] Systems and methods for measuring vascular compliance according to the present invention may be configured to obtain pressure-volume measurements before, during, and after treatment. Data obtained during these measurements can be used to obtain changes in vascular compliance and determine treatment effectiveness. Changes in vascular compliance may further be used to adjust treatment intensity and / or duration.

[0203] Additionally, embodiments of the present invention may be used to generate pressure-volume (i.e., compliance curves) at various times during treatment. Relative changes in compliance before and after treatment may be obtained. These changes may be compared between similar vessel segments to understand the appropriate level of compliance change.

[0204] Additionally, methods of the present invention may further utilize other available measurement techniques, such as ultrasound, cine angiography, computed tomography, intravascular ultrasound (IVUS), and / or optical coherence tomography (OCT), to obtain indirect measurements of arterial cross-sections. In some cases, systems of the present invention may be configured to incorporate information derived from such measurements, i.e., sensor fusion techniques. Volume and / or area measurements obtained from such visualization techniques may be combined with pressure and volume readings (i.e., measurements of relative volume and / or pressure changes) from embodiments of the pulsed intravascular disruption subsystem of the present invention to generate absolute vascular compliance measurements with greater accuracy. Such absolute compliance measurements may then be used to compare treatments between vascular beds to optimize treatments for both short-term and long-term success. Additionally, absolute measurements of vascular compliance curves may be obtained and compared between treatment groups.

[0205] Although the systems and methods for measuring vascular compliance are described in the context of the system of the present invention, such systems and methods for measuring vascular compliance may likewise be applied to other systems, such as systems configured to perform static balloon angioplasty, pulsed endovascular atherectomy, cavitation-based endovascular atherectomy, and / or externally applied disruption pulses, and / or atherectomy-based procedures, alone or in conjunction with any such procedures. Further details regarding how the systems of the present invention may be used include those described in U.S. Pat. No. 1,464,949, U.S. Patent Application Publication No. 2020 / 0046949, pending International Application No. PCT / US2020 / 055458, and pending International Application No. PCT / US2022 / 014785, the disclosures of which are incorporated herein by reference.

[0206] As described, methods of embodiments of the present invention use embodiments of the system of the present invention as described herein to perform atherectomy, i.e., an atherectomy procedure. Methods of embodiments of the present invention use embodiments of the system of the present invention as described herein to perform pulsed endovascular ablation, i.e., a pulsed endovascular ablation procedure. Methods of embodiments of the present invention use embodiments of the system of the present invention as described herein to perform atherectomy and pulsed endovascular ablation, i.e., atherectomy and pulsed endovascular ablation procedures. Method embodiments of the present invention perform atherectomy using the atherectomy subsystem of systems of embodiments of the present invention and perform pulsed endovascular ablation using the pulsed endovascular ablation subsystem of systems of embodiments of the present invention.

[0207] In another embodiment of the method of the present invention, a system according to an embodiment of the present invention is deployed so that an atherectomy tool of the system is adjacent to an occlusion in the diseased vessel, the system is actuated so that the atherectomy tool forms a channel in the occlusion in the diseased vessel, a balloon of the system is guided through the channel, and the system is actuated to deliver pulsed energy to the diseased vessel. In some cases, the balloon is guided to an area adjacent to the channel. In other cases, the balloon is guided to an interior area of ​​the channel. In some embodiments, the system is actuated so that the atherectomy tool forms the channel by grinding the channel with the atherectomy tool. In other embodiments, the atherectomy tool is rotated or orbited when the system is actuated so that the atherectomy tool forms the channel. In some cases, forming the channel involves creating a new channel, such as by drilling a hole, or dilating an existing channel, and in either case, a balloon of a pulsed endovascular disruption subsystem can be directed into the channel as desired to perform pulsed endovascular disruption within the channel.

[0208] Further details regarding how embodiments of the present invention may be used, including further details regarding pulsed intravascular disruption, dynamic balloon angioplasty (DBA), vessel compliance, and the like, utilizing embodiments of the present system, are described in U.S. Pat. No. 11,464,949, U.S. Patent Application Publication No. 2020 / 0046949, U.S. Application No. 17,897,604, pending International Application No. PCT / US2019 / 027139, pending International Application No. PCT / US2020 / 055458, U.S. Application No. 6,327,483, the disclosures of each of which are incorporated herein by reference. 2, U.S. Application No. 17827169, pending International Application No. PCT / US2022 / 014785, U.S. Application No. 63238381, pending International Application No. PCT / US2022 / 040586, U.S. Application No. 63346703, pending International Application No. PCT / US23 / 23533, U.S. Application No. 63346704, pending International Application No. PCT / US23 / 22685, U.S. Application No. 63444414, and U.S. Application No. 63545060.

[0209] Regardless of the scope of the appended claims, the present disclosure is also defined by the following appendix.

[0210] Appendix 1. Console, handle, an atherectomy subsystem; and Pulsed intravascular disruption subsystem A system comprising:

[0211] Appendix 2. Console and a handle configured to be interchangeably and operably connectable to the atherectomy subsystem and the pulsed endovascular disruption subsystem; A system comprising:

[0212] Clause 3. The system of clause 2, wherein the handle is operably connected to the atherectomy subsystem.

[0213] Clause 4. The system of clause 2, wherein the handle is operably connected to a pulsed intravascular disruption subsystem.

[0214] Appendix 5. The system of any one of Appendixes 1 to 4, wherein the atherectomy subsystem and the pulsed intravascular disruption subsystem each have an interface configured to operably connect to an interface of the handle.

[0215] Appendix 6. The system of Appendix 5, wherein the atherectomy subsystem interface and the pulsed intravascular disruption subsystem interface each have a linkage configured to link with the handle interface.

[0216] Appendix 7. The system of any one of appendices 1 to 6, wherein the atherectomy subsystem includes an atherectomy tool.

[0217] Clause 8. The system of clause 7, wherein the atherectomy tool comprises a rotational atherectomy tool.

[0218] Appendix 9. The system of any one of Appendixes 7 to 8, wherein the atherectomy tool comprises an orbital atherectomy tool.

[0219] Clause 10. The system of any one of clauses 7-9, wherein the atherectomy tool comprises one or more of a laser tool, an ultrasonic tool, an electrohydraulic fracturing (EHL) cavitation emitter tool, or a mechanotransduction tool.

[0220] Appendix 11. The system of any one of appendices 7 to 10, wherein the atherectomy tool is configured to grind within the lesion.

[0221] Appendix 12. A system according to any one of appendices 7 to 11, wherein the atherectomy tool is provided in a distal region of the system.

[0222] Appendix 13. The system of any one of appendices 7 to 12, wherein the atherectomy tool is configured to traverse the lesion.

[0223] Appendix 14. The system of any one of appendices 7 to 13, wherein the atherectomy tool is configured to cross the occluded lesion.

[0224] Addendum 15. The system of any one of Addendums 7 to 14, wherein the atherectomy tool is configured to cross a chronic total occlusion (CTO).

[0225] Addendum 16. The system of any one of Addendums 7 to 15, wherein the atherectomy tool is configured to form a new channel within the lesion.

[0226] Addendum 17. The system of any one of Addendums 7 to 16, wherein the atherectomy tool is configured to create a hole within the lesion.

[0227] Appendix 18. The system of any one of appendices 7 to 17, wherein the atherectomy tool is a burr.

[0228] Clause 19. The system of clause 18, wherein the bur is a grinding bur.

[0229] Addendum 20. The system of any one of Addendums 1 to 19, wherein the atherectomy subsystem includes a rotational assembly configured to generate rotational energy.

[0230] Clause 21. The system of clause 20, wherein the rotating assembly is operably connected to the console.

[0231] Clause 22. The system of clause 20 or 21, wherein the rotational assembly is configured to convert energy transmitted from the console into rotational energy.

[0232] Addendum 23. The system of any one of Addendums 20-22, wherein the rotating assembly is operably connected to a console potential source.

[0233] Addendum 24. The system of any one of Addendums 20 to 23, wherein the rotating assembly is a motor.

[0234] Addendum 25. The system of any one of Addendums 1 to 24, configured to rotate the atherectomy tool.

[0235] Addendum 26. The system of any one of Addendums 1 to 25, configured to orbit the atherectomy tool.

[0236] Appendix 27. The system of any one of appendices 1 to 26, configured to both rotate and orbit the atherectomy tool.

[0237] Addendum 28. The system of any one of Addendums 1 to 27, wherein the atherectomy subsystem includes a lateral transmission assembly configured to transmit rotational energy from the rotation assembly to the atherectomy tool.

[0238] Item 29. The system of item 28, wherein the lateral transmission assembly is positioned distal to the rotation assembly and proximal to the atherectomy tool.

[0239] Addendum 30. The system of any one of Addendums 28 to 29, wherein the lateral transmission assembly includes a rotary drive shaft.

[0240] Clause 31. The system of clause 30, wherein the rotary drive shaft is a flexible drive shaft.

[0241] Addendum 32. The system of any one of Addendums 28 to 31, wherein the lateral transmission assembly is configured to receive a guidewire.

[0242] Addendum 33. A system described in any one of Addendums 28 to 32, wherein the lateral transmission assembly has a guidewire lumen.

[0243] Addendum 34. The system of any one of Addendums 28 to 33, wherein the lateral transmission assembly includes a guidewire.

[0244] Addendum 35. The system of any one of Addendums 28 to 34, wherein the lateral transmission assembly has a fluid bearing.

[0245] Addendum 36. The system of Addendum 35, wherein the fluid bearing is configured to dissipate heat.

[0246] Addendum 37. The system of Addendum 35 or 36, wherein the fluid bearing has a fluid within the guidewire lumen.

[0247] Item 38. The system of item 34, wherein the guidewire is configured to provide stability to the lateral transmission assembly while transmitting rotational energy from the rotation assembly to the atherectomy tool.

[0248] Addendum 39. The system of any one of Addendums 1 to 38, wherein the atherectomy subsystem has an atherectomy tool configured to utilize mechanotransduction of the guidewire to create a hole through the lesion.

[0249] Addendum 40. The system of any one of Addendums 1 to 39, wherein the atherectomy subsystem has an advancer configured to advance and retract the atherectomy tool distally and proximally.

[0250] Addendum 41. The system of Addendum 40, wherein the advancer is configured to pulse the atherectomy tool in and out of the lesion.

[0251] Addendum 42. The system of any one of Addendums 1 to 41, wherein the atherectomy subsystem includes a filter positioned distal to the atherectomy tool.

[0252] Clause 43. The system of clause 42, wherein the filter is configured to protect the vasculature from distal embolism.

[0253] Addendum 44. The system of any one of Addendums 1 to 43, wherein the atherectomy subsystem includes a sensor.

[0254] Clause 45. The system of clause 44, wherein the sensor is configured to sense one or more of current, rotational position, velocity, acceleration, temperature, linear position, torque, pressure, or flow rate.

[0255] Addendum 46. The system of Addendum 44 or 45, wherein the sensor is configured to detect electrical current associated with the atherectomy subsystem in contact with the lesion.

[0256] Addendum 47. A system described in any one of Addendums 44 to 46, wherein the sensor is configured to detect a current response to the atherectomy subsystem penetrating the lesion.

[0257] Addendum 48. The system of any one of Addendums 1 to 47, wherein the lesion portion includes a calcified plaque.

[0258] Item 49. The system of any one of Items 1-48, wherein the pulsed intravascular disruption subsystem includes a balloon catheter assembly.

[0259] Appendix 50. A balloon catheter assembly comprising: (a) a proximal connector operatively connecting the balloon catheter assembly to the handle and configured to convert first pulse energy generated by the pulse generator into second pulse energy; (b) a distal balloon; (c) a catheter element having a fluid passageway operably disposed between the proximal connector and the distal balloon, the catheter element being configured to propagate the second pulsed energy from the proximal connector along the fluid passageway to the distal balloon; 49. The system of claim 49, comprising:

[0260] Appendix 51. The pulsed intravascular disruption subsystem is Proximal connector, a distal balloon, and catheter It has 51. The system of any one of claims 1 to 50, wherein the distal balloon is operably connected to the catheter, and the catheter is operably connected to the proximal connector.

[0261] Addendum 52. The system of any one of Addendums 50 to 51, wherein the proximal connector is configured to be operably connected to the handle.

[0262] Addendum 53. The system of any one of Addendums 50-52, wherein the proximal connector and the connector of the atherectomy subsystem each have the same handle interface.

[0263] Item 54. The system of any one of items 50-53, wherein the atherectomy subsystem and the pulsed intravascular disruption subsystem are integrated together.

[0264] Appendix 55. Atherectomy subsystem, and Pulsed intravascular disruption subsystem 55. The system of any one of claims 1-54, further comprising an integrated atherectomy and pulsed endovascular laser (PELA) laser sub-system,

[0265] Item 56. The system of any one of items 1 to 55, which is an integrated atherectomy and pulsed endovascular atherectomy system.

[0266] Addendum 57. The system of any one of Addendums 1 to 56, wherein the atherectomy subsystem and the pulsed intravascular disruption subsystem comprise an integrated tool.

[0267] Addendum 58. The system of any one of Addendums 1 to 57, wherein the atherectomy subsystem and the pulsed intravascular disruption subsystem have a common distal region.

[0268] Addendum 59. The system of any one of Addendums 1 to 58, wherein the pulsed intravascular disruption subsystem has a guidewire lumen, and the atherectomy subsystem has a lateral transmission assembly having a guidewire, the guidewire being disposed within the guidewire lumen.

[0269] Addendum 60. The system of Addendum 59, wherein the atherectomy tool is provided in a distal region of the guidewire.

[0270] Appendix 61. The atherectomy subsystem has a guidewire; 61. The system of any one of claims 1-60, wherein the pulsed intravascular disruption subsystem comprises a guidewire.

[0271] Appendix 62. The system of any one of appendices 1 to 61, which is an OTW (over the wire) system.

[0272] Item 63. The system of item 62, wherein a guidewire is provided along the majority of the length of the atherectomy subsystem and the pulsed intravascular disruption subsystem.

[0273] Appendix 64. The system of any one of appendices 1 to 63, which is an RX (rapid exchange) system.

[0274] Item 65. The system of item 64, wherein the guidewire is provided only in the distal regions of the atherectomy subsystem and the pulsed intravascular disruption subsystem.

[0275] Item 66. The system of any one of items 1 to 65, comprising a guidewire, wherein a distal region of the guidewire is coated with an abrasive material.

[0276] Item 67. The system of item 66, wherein the abrasive material coating comprises an atherectomy tool.

[0277] Addendum 68. The system of any one of Addendums 66 to 67, wherein the abrasive material coating comprises a distal burr.

[0278] Addendum 69. The system of any one of Addendums 66-68, wherein the abrasive material coating has a predetermined diameter selected based on treatment efficacy.

[0279] Addendum 70. The system of any one of Addendums 66-69, wherein the abrasive material coating has a predetermined diameter selected based on the diameter of the distal balloon of the pulsed intravascular disruption subsystem.

[0280] Item 71. The system of item 70, wherein the predetermined diameter is selected so that the distal balloon of the pulsed intravascular fracturing subsystem can be inserted into the hole created by the abrasive material.

[0281] Item 72. The system of any one of Items 1-71, wherein the pulsed intravascular disruption subsystem has a guidewire lumen.

[0282] Item 73. The system of item 72, wherein the guidewire is disposed within the guidewire lumen of the pulsed intravascular disruption subsystem.

[0283] Clause 74. The system of any one of clauses 1 to 73, further comprising a filter disposed on the guidewire distal to the atherectomy tool.

[0284] 75. The system of claim 74, wherein the filter is configured to protect the vasculature from distal embolism.

[0285] Addendum 76. The system of any one of Addendums 1 to 75, wherein the atherectomy subsystem and the pulsed intravascular disruption subsystem have separate distal regions.

[0286] Item 77. The system of any one of items 1 to 76, wherein the catheter element of the pulsed intravascular disruption subsystem is separate from the atherectomy subsystem.

[0287] Addendum 78. The system of any one of Addendums 76 and 77, wherein separate distal regions of the atherectomy subsystem and the pulsed intravascular disruption subsystem are configured to interact with a guidewire.

[0288] Clause 79. The system of any one of clauses 1-78, further comprising a console operably connected to a potential source operably connected to the handle assembly.

[0289] Clause 80. The system of any one of clauses 1-79, further comprising a controller configured to receive input from a source external to the system.

[0290] Addendum 81. The system of any one of Addendums 1-80, further comprising a controller configured to receive input from at least one of an electrocardiogram, an intravascular pressure monitor, a blood volume monitor, or results from an imaging system.

[0291] Addendum 82. The system of any one of Addendums 79-81, wherein the console is a first console and the system comprises a plurality of operably connected consoles.

[0292] Addendum 83. The system of any one of Addendums 79 to 82, wherein the console has a pulse generator.

[0293] 84. The system of claim 83, wherein the pulse generator is configured to generate pneumatic pulse energy.

[0294] Addendum 85. The system of any one of Addendums 83 and 84, wherein the pulse generator is configured to generate pressure pulses having an amplitude selected based on treatment efficacy.

[0295] Addendum 86. The system of any one of Addendums 83 to 85, wherein the pulse generator is configured to generate static pneumatic energy.

[0296] Addendum 87. The system of any one of Addendums 1 to 86, further comprising a potential source.

[0297] Addendum 88. The system of Addendum 87, wherein the potential source is a voltage potential, an electromagnetic potential, or a pressure potential.

[0298] Addendum 89. The system of any one of Addendums 79-88, wherein the console has a regulator configured to adjust the first energy from the potential source to the second energy.

[0299] Addendum 90. The system of Addendum 89, wherein the regulator is an active regulator configured to be controlled by an electrical signal.

[0300] Addendum 91. The system of any one of Addendums 89 to 90, wherein the regulator is a passive regulator configured to be pre-set to a particular output.

[0301] Addendum 92. The system of any one of Addendums 1 to 91, comprising a control unit configured to control the console.

[0302] Addendum 93. The system of Addendum 92, wherein the console has a control unit.

[0303] Supplementary Note 94. The control unit is receiving input from at least one of a console, a handle, an atherectomy subsystem, or a pulsed endovascular disruption subsystem; adjusting a configuration of at least one of the console, the handle, the atherectomy subsystem, or the pulsed endovascular disruption subsystem based at least in part on the received input; 94. The system of claim 92 or 93, configured as follows:

[0304] Addendum 95. The system of any one of Addendums 92-94, wherein the control unit is configured to receive input from a source external to the system.

[0305] Addendum 96. The system of any one of Addendums 92-95, wherein the control unit is configured to receive input from at least one of an electrocardiogram, an intravascular pressure monitor, a blood volume monitor, or results from an imaging system.

[0306] Addendum 97. The system of any one of Addendums 92-96, wherein the console is a first console and the system comprises a plurality of operably connected consoles.

[0307] Clause 98. The system of clause 97, wherein the plurality of consoles are operably connected to the switch.

[0308] Addendum 99. The system of any one of Addendums 1 to 98, further comprising a switch.

[0309] Clause 100. The system of clause 99, wherein the switch is operably connected to the output of the potential source.

[0310] Clause 101. The system of any one of clauses 99 to 100, wherein the switch is configured to controllably transfer energy received from the potential source to one or more outputs.

[0311] Addendum 102. The system of any one of Addendums 99-101, wherein the switch is configured to output energy of an oscillatory magnitude.

[0312] Addendum 103. The system of any one of Addendums 99-102, wherein the switch is configured to output an oscillating output pressure.

[0313] Addendum 104. The system of any one of Addendums 99 to 103, wherein the switch is an oscillator.

[0314] Addendum 105. The system of any one of Addendums 99-104, wherein the switch is configured to output energy of a static magnitude.

[0315] Addendum 106. The system of any one of Addendums 99 to 105, wherein the switch is configured to output a static output pressure.

[0316] Addendum 107. A system described in any one of Addendums 104 to 106, wherein the oscillator is configured to synchronize the oscillator's vibration frequency with the electrocardiogram results.

[0317] Addendum 108. The system of any one of Addendums 99 to 107, wherein the switch comprises a mechanical switch or an electrical switch.

[0318] Addendum 109. The system of any one of Addendums 99-108, wherein the switch has a solenoid.

[0319] Addendum 110. The system of any one of Addendums 1 to 109, further configured to detect a system state.

[0320] Addendum 111. The system of any one of Addendums 1 to 110, wherein the handle is operably connected to the console.

[0321] Addendum 112. The system of any one of Addendums 1 to 111, wherein the handle is configured to be operably connected to each of the atherectomy subsystem and the pulsed intravascular disruption subsystem.

[0322] Addendum 113. The system of any one of Addendums 1 to 112, wherein the handle is configured to be operably connected to (a) a first connector of the atherectomy subsystem and (b) a second connector of the pulsed intravascular disruption subsystem.

[0323] Addendum 114. The system of any one of Addendums 1 to 113, wherein the handle is configured to be releasably connected to each of the atherectomy subsystem and the pulsed intravascular disruption subsystem.

[0324] Addendum 115. The system of any one of Addendums 1 to 114, wherein the handle is operably connected to the atherectomy subsystem and the pulsed intravascular disruption subsystem.

[0325] Addendum 116. A system described in any one of Addendums 1 to 115, wherein the handle has a linkage configured to link with each of the atherectomy subsystem and the pulsed intravascular disruption subsystem.

[0326] Addendum 117. The system of any one of Addendums 1 to 116, wherein the handle has one unit housing a switch configured to transmit energy to a subsystem connected to the handle.

[0327] Addendum 118. The system of any one of Addendums 1 to 117, further comprising a rotational assembly configured to generate rotational energy for the atherectomy subsystem.

[0328] Addendum 119. The system of any one of Addendums 1 to 118, wherein the handle is configured to be held by an operator.

[0329] Addendum 120. The system of any one of Addendums 1 to 119, wherein the handle is configured to be held by an operator during use.

[0330] Addendum 121. The system of any one of Addendums 1 to 120, wherein the handle weight is within the range of 0.5 pounds to 2.5 pounds.

[0331] Addendum 122. The system of any one of Addendums 1 to 121, wherein the handle circumference is within the range of 1.5 inches to 5.0 inches.

[0332] Addendum 123. The system of any one of Addendums 1 to 122, wherein the handle length is within the range of 4.0 inches to 8.0 inches.

[0333] Addendum 124. The system of any one of Addendums 1 to 123, wherein the handle has one or more tactile features.

[0334] Clause 125. The system of clause 124, wherein the tactile features include grooves or depressions.

[0335] Appendix 126. Console and The handle and an integrated atherectomy and pulsed endovascular disruption subsystem having an atherectomy subsystem and a pulsed endovascular disruption subsystem; A system comprising:

[0336] Appendix 127. A console according to any one of appendices 1 to 126.

[0337] Appendix 128. A handle according to any one of Appendixes 1 to 127.

[0338] Addendum 129. The atherectomy subsystem of the system of any one of Addendums 1-126.

[0339] Attachment 130. A pulsed intravascular disruption subsystem of the system of any one of attachments 1-126.

[0340] Appendix 131. A method of performing pulsed intravascular lithotripsy using the system of any one of appendices 1-126.

[0341] Appendix 132. A method of performing atherectomy using a system according to any one of appendices 1-126.

[0342] Appendix 133. A method of performing atherectomy and pulsed endovascular atherectomy using the system of any one of appendices 1-126.

[0343] Attachment 134. Performing an atherectomy procedure using the atherectomy subsystem of the system of any one of attachments 1-126; A method of performing pulsed endovascular disruption using a pulsed endovascular disruption subsystem of the system.

[0344] Item 135. Introducing a combined atherectomy subsystem and pulsed endovascular subsystem tool of the system of any one of items 1 to 126 into luminal tissue; performing an atherectomy procedure using the atherectomy subsystem; A method for performing pulsed endovascular disruption using a pulsed endovascular disruption subsystem.

[0345] Appendix 136. A guidewire is introduced into the luminal tissue; introducing an atherectomy tool of the atherectomy subsystem of the system of any one of claims 1 to 126 into the luminal tissue using a guidewire; Remove the atherectomy subsystem from the luminal tissue. The method includes using a guidewire to introduce a distal balloon of a pulsed endovascular disruption subsystem of the system into the luminal tissue.

[0346] Appendix 137. A method for treating a diseased blood vessel, comprising: deploying the atherectomy tool of the system of any one of claims 1 to 126 adjacent to the occlusion of the affected blood vessel; activating the system so that the atherectomy tool forms a channel at the occlusion of the diseased blood vessel; Guide the balloon of the system through the channel, The method includes activating the system to deliver pulsed energy to the affected vessel.

[0347] Addendum 138. The method of Addendum 137, wherein when guiding the balloon, the balloon is guided into a region adjacent to the channel.

[0348] Addendum 139. The method of Addendum 137 or 138, wherein when guiding the balloon, the balloon is guided into an interior region of the channel.

[0349] Addendum 140. The method of any one of Addendums 137-139, wherein the channel is ground using an atherectomy tool when the system is actuated so that the atherectomy tool forms the channel.

[0350] Addendum 141. The method of any one of Addendums 137-140, wherein the atherectomy tool is rotated or orbited when the system is actuated so that the atherectomy tool forms the channel.

[0351] Clause 142. A kit comprising one or more elements of the system described in any one of clauses 1 to 126.

[0352] Clause 143. The kit of clause 142, further comprising packaging for one or more components.

[0353] Addendum 144. The kit of any one of Addendums 142 and 143, wherein one or more components of the kit are reusable.

[0354] Item 145. The kit of any one of items 142 to 144, wherein one or more components of the kit are sterile.

[0355] It is to be understood that the invention is not limited to the particular embodiments described, as such may, of course, vary. The scope of the present invention will be limited only by the appended claims, and it is to be further understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

[0356] In at least some of the described embodiments, one or more elements used in an embodiment may be used interchangeably in another embodiment, unless the substitution is technically infeasible. It will be understood by those skilled in the art that various other omissions, additions, and modifications may be made to the methods and structures described herein without departing from the scope of the claimed subject matter. All such modifications and variations are intended to fall within the scope of the subject matter defined by the appended claims.

[0357] When a range of values ​​is given, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly indicates otherwise, between the upper and lower limits of that range, and any other stated or intervening value in that stated range, is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also encompassed within the invention.

[0358] Certain ranges are presented herein, and numerical values ​​are preceded by the term "about." The term "about" is used herein to provide literal support for the exact number preceded by the term, as well as for a number that is close to or approximately the number preceded by the term. When determining whether a number is close to or approximately a specifically stated number, the unstated number that is close or approximately the number may be a number that, in the context in which the specifically stated number is presented, provides a substantial equivalent to the specifically stated number.

[0359] As will be understood by those skilled in the art, for all purposes, including those described in the specification, all ranges disclosed herein further encompass any and all possible subranges and combinations of these subranges. Any recited range can be readily recognized as being sufficiently descriptive to allow that same range to be divided into at least equal halves, thirds, quarters, fifths, tenths, etc. As a non-limiting example, each range described herein can be readily divided into a lower third, middle third, upper third, etc. As will be further understood by those skilled in the art, all terms such as "up to," "at least," "greater than," "less than," etc., refer to ranges that are inclusive of the recited number and that can subsequently be divided into subranges as previously described. Finally, as will be understood by those skilled in the art, ranges include each individual member. Thus, for example, a group having 1 to 3 elements refers to groups having 1, 2, or 3 elements. Similarly, a group having 1 to 5 elements refers to groups having 1, 2, 3, 4, or 5 elements, etc.

[0360] 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 described.

[0361] All publications and patents cited herein are incorporated by reference as if each individual publication or patent was specifically and individually indicated to be incorporated by reference, and are incorporated by reference herein for any purpose, including, but not limited to, disclosing and describing the methods and / or materials in connection with which the publications are cited. 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 prior invention. Further, the dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed.

[0362] It should be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. It should be further noted that the claims may be drafted to exclude any optional element. Accordingly, this statement is intended to serve as a predicate for use of exclusive terminology such as "solely," "only," and the like, or for use of a "negative" limitation in connection with the recitation of claim elements.

[0363] As will be apparent to those skilled in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein comprises separate components and features which may be readily separated from or combined with any of the features of the other multiple embodiments without departing from the scope or spirit of the invention. Any recited method may be carried out in the order of events recited or in any other order which is logically possible.

[0364] Those skilled in the art will understand that the terms used in this specification generally, and in the appended claims in particular (e.g., the body of the appended claims), are generally intended as "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," and the term "includes" should be interpreted as "including, but not limited to"). Those skilled in the art will further understand that where a specific number of introduced claim recitations are intended, such intention will be explicitly set forth in the claim, and that in the absence of such recitation, no such intention exists. For example, the following appended claims may include the use of the introductory phrases "at least one" and "one or more" to introduce the claim recitations as an aid to understanding. However, the use of such introductory phrases should not be construed as meaning that introducing a claim recitation with the indefinite article "a" or "an" limits any particular claim that includes the claim recitation so introduced to embodiments that include only one such recitation, even if the same claim also includes the introductory phrase "one or more" or "at least one" and an indefinite article, e.g., "a" or "an" (e.g., "a" and / or "an" should be construed to mean "at least one" or "one or more"). The same applies to the use of definite articles used to introduce claim recitations. Additionally, even if a specific number of recitations in an introduced claim is explicitly stated, those skilled in the art will recognize that such recitation should be construed to mean at least the recited number (e.g., the literal recitation "two recitations" means at least two recitations or more than two recitations, without any other modifier).Furthermore, when a convention similar to "at least one of A, B, and C, etc." is used, such a configuration is generally intended in the sense that one of ordinary skill in the art would understand this convention (e.g., "a system comprising at least one of A, B, and C" includes, but is not limited to, systems with A only, B only, C only, both A and B, both A and C, both B and C, and / or both A, B, and C, etc.). When a convention similar to "at least one of A, B, or C, etc." is used, such a configuration is generally intended in the sense that one of ordinary skill in the art would understand this convention (e.g., "a system comprising at least one of A, B, or C" includes, but is not limited to, systems with A only, B only, C only, both A and B, both A and C, both B and C, and / or both A, B, and C, etc.). Those of ordinary skill in the art will further appreciate that virtually any disjunctive word and / or disjunctive phrase expressing two or more alternative terms, whether in the specification, claims, or drawings, should be understood to contemplate the possibility of including one of the terms, either of the terms, or both terms. For example, the phrase "A or B" is understood to include the possibilities of "A" or "B" or "A and B."

[0365] Additionally, when features or aspects of the disclosure are described in Markush format, those skilled in the art will recognize that the disclosure is further described with respect to every individual member or subgroup member of the Markush group.

[0366] Although the present invention has been described in some detail by way of illustration and example for clarity of understanding, it will be readily apparent to those skilled in the art in view of the teachings of the present invention that certain changes and modifications may be made thereto without departing from the spirit or scope of the appended claims.

[0367] Accordingly, the disclosure of the present invention merely illustrates the principles of the invention. Those skilled in the art will understand that, although not explicitly described or shown herein, they may devise various configurations which embody the principles of the invention and are within the spirit and scope of the invention. Furthermore, all examples and conditional language set forth herein are intended essentially to aid the reader in understanding the essence of the invention and the concepts provided by the inventors to advance the art, and should not be construed as limiting to the examples and conditions specifically set forth. Furthermore, all statements herein reciting the essence, aspects, and embodiments of the invention, as well as specific examples of the invention, are intended to encompass both structural and functional equivalents of the invention. Additionally, such equivalents are intended to include both currently known equivalents and future-developed equivalents, i.e., all elements developed that perform the same function, regardless of structure. Furthermore, the descriptions disclosed herein are not intended to be publicly disclosed, regardless of whether such disclosure is explicitly set forth in the claims.

[0368] Although the systems, devices, methods, and kits have been or will be described for grammatical fluidity with functional descriptions, it should be clearly understood that the claims, unless expressly recited under 35 U.S.C. 112, should not be construed as necessarily limited in any way by limitations of "means" or "step" construction, but should be accorded the full scope of the meaning and equivalents of the definition given by the claims under the judicial theory of equivalents, and that if a claim is expressly recited under 35 U.S.C. 112, it should be accorded the full legal equivalents under 35 U.S.C. 112.

[0369] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority under 35 U.S.C. §119(e) of the filing date of U.S. Provisional Patent Application No. 63 / 444,414, filed February 9, 2023, the entire disclosure of which is incorporated herein by reference.

Claims

1. The console and a handle configured to be interchangeably and operably connectable to the atherectomy subsystem and the pulsed endovascular disruption subsystem; A system comprising:

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

3. The system of claim 1 , wherein the handle is operably connected to the pulsed intravascular disruption subsystem.

4. The system of any one of claims 1 to 3, wherein the atherectomy subsystem and the pulsed intravascular disruption subsystem each have an interface configured to operably connect to an interface of the handle.

5. 5. The system of claim 1, wherein the atherectomy subsystem comprises an atherectomy tool that is a rotational atherectomy tool, or an orbital atherectomy tool, or a laser tool, or an ultrasonic tool, or an electrohydraulic fragmentation (EHL) cavitation emitter tool, or a mechanotransduction tool.

6. The system of any one of claims 1 to 5, wherein the atherectomy subsystem includes a rotational assembly configured to convert energy transmitted from the console into rotational energy.

7. The system of any one of claims 1 to 6, wherein the atherectomy subsystem includes a lateral transmission assembly configured to transmit rotational energy from the rotation assembly to an atherectomy tool.

8. 8. The system of claim 1, wherein the atherectomy subsystem comprises a sensor configured to sense one or more of: current, rotational position, velocity, acceleration, temperature, linear position, torque, pressure, or flow.

9. The pulsed intravascular disruption subsystem comprises: a proximal connector configured to operably connect to the handle; a distal balloon, and catheter It has The system of any one of claims 1 to 8, wherein the distal balloon is operably connected to the catheter, and the catheter is operably connected to the proximal connector.

10. The system of claim 9 , wherein the proximal connector and the atherectomy subsystem connector each have the same handle interface.

11. 11. The system of claim 1, further comprising an integrated atherectomy and pulsed endovascular disruption subsystem having the atherectomy subsystem and the pulsed endovascular disruption subsystem.

12. 12. The system of claim 1, wherein the pulsed intravascular disruption subsystem has a guidewire lumen, and the atherectomy subsystem has a lateral delivery assembly having a guidewire, the guidewire being disposed within the guidewire lumen.

13. The system of claim 12 , wherein the atherectomy tool is disposed on a distal region of the guidewire.

14. 1. A method of treating a diseased blood vessel, comprising: Deploying the atherectomy tool of the system according to any one of claims 1 to 13 so that the atherectomy tool is adjacent to the occlusion of the diseased blood vessel; activating the system so that the atherectomy tool forms a channel at the occluded portion of the diseased blood vessel; directing a distal balloon of the system through the channel; activating the system to deliver pulsed energy to the affected blood vessel.

15. A guidewire is introduced into the luminal tissue; using the guidewire to introduce an atherectomy tool of an 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; The method further comprises using the guidewire to introduce a distal balloon of a pulsed intravascular disruption subsystem of the system into luminal tissue.

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