Manifold systems and devices for applying pulsed endovascular lithotripsy, and methods thereof.

Abstract

Systems, devices, and methods for treating diseased blood vessels using pulsed endovascular lithotripsy are disclosed herein. In particular, an amplifier assembly is provided. A handle assembly for controllably transmitting potential energy is also provided. A system for delivering pulsed energy is provided, such a system including an amplifier assembly and a handle assembly. A method for delivering pulsed energy to tissue is provided.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] Pursuant to 35 U.S.C. § 119(e), this application claims priority to the filing date of U.S. Provisional Patent Application No. 63,545,060 filed on October 20, 2023, the disclosure of which is hereby incorporated by reference in its entirety herein. BACKGROUND ART

[0002] Ischemic heart disease, the leading cause of death worldwide, is caused by the accumulation of atherosclerotic plaques within the human vasculature. Globally, these diseases account for 84.5% of cardiovascular deaths and 28.2% of all deaths. Ischemic heart disease develops via a mechanism called atherosclerosis, which is the accumulation of fatty and calcified substances that cause stenosis, the narrowing of the arterial lumen. Both coronary arteries and peripheral arteries can suffer from atherosclerotic plaque accumulation. Plaque buildup due to atherosclerosis 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, but over time and with disease progression, these plaques physically harden or calcify. Calcified plaques (CP), i.e., lesions that develop in the innermost layer of the arterial wall, occur most frequently. These CPs result from the deposition and remodeling of calcium hydroxyapatite, a process that resembles bone formation. Vessels with CP have reduced vascular elasticity and impaired vascular perfusion. Due to this reduced compliance and perfusion, CPs are associated with an increased risk of death and other adverse events.

[0003] Many patients with CP are asymptomatic, but a significant number develop ischemia-related symptoms and signs and undergo endovascular or surgical repair. Endovascular treatment is generally preferred due to its low complication rate. However, vessels with CP present unique challenges to effective endovascular treatment. A range of devices are often used to treat vessels with CP. CP lesions are first pre-dilated using balloon angioplasty (BA). In BA, a balloon is advanced to the affected artery and inflated to dilate the plaque-containing vessel and restore normal blood flow. This pre-dilation step must be successful for secondary therapies, such as drug-coated balloons or stents, to be properly used. For successful pre-dilation, BA must mechanically break up the CP to ensure long-term openness, i.e., patency, of the vessel and restore elasticity to the surrounding healthy vessel. Often, high-pressure non-compliant balloons are used to achieve success. However, the strength of the CP often limits full balloon inflation, leaving the CP unbroken. Without sufficient balloon inflation and CP rupture, residual stenosis remains in the vessel, restricting downstream blood flow. This suggests a poor prognosis, a high risk of immediate or long-term failure, and the need for additional treatment. To ensure patency of the affected vessel, the high rupture strength of the CP must be overcome.

[0004] In standard BA (vascular angioplasty), a pressurized catheter balloon is used to break up atherosclerotic plaque and push it into the arterial wall to restore normal blood flow in the narrowed artery. Typically, the balloon is pressurized via a manually operated screw-driven syringe, which translates the rotation of a handle operated by the physician into the displacement of a syringe piston. The syringe handle is rotated by the physician until the pressure in the system reaches the desired pressure or until the physician senses that the calcified plaque has been broken up. During the procedure, the physician can sense whether the calcified plaque has been broken up in two ways: (1) from the balloon's contour under fluoroscopy, a medical imaging technique commonly used in cardiovascular procedures, and (2) from a drop in pressure in the hydraulic system indicated by a pressure gauge. In angioplasty, a radiopaque dye (i.e., contrast agent) is introduced into the balloon, which visualizes the balloon and the arterial wall contour under fluoroscopy. When the plaque is intact and the balloon is pressurized, the balloon takes on a characteristic dogbone shape, such that the proximal and distal ends are not constrained to inflate, but the center is occluded by the plaque. The dogbone shape informs the physician of the severity and distribution of the plaque. A more uniformly inflated balloon indicates to the physician that the plaque has been treated. A second method used to sense plaque fragmentation is indicated by a pressure gauge attached to the balloon. When treating severe and / or circumferentially distributed plaque, the pressure inside the balloon increases until the plaque is fragmented. Before plaque fragmentation, the balloon maintains the aforementioned dogbone shape. Once fragmented, the plaque no longer constrains balloon inflation, and the balloon expands the plaque into the elastic artery. This balloon inflation increases the volume of the balloon, deforming it from a dogbone shape to a fully inflated cylindrical shape. This volume increase decreases the pressure inside the balloon, causing a change that can be visualized or sensed from a connected pressure gauge.

[0005] To overcome the rupture strength of CP, vessels containing CP are often aggressively inflated using angioplasty balloons. In these cases, the balloons are pressurized beyond their rated rupture pressure (i.e., pressures exceeding 20–40 ATM) to achieve sufficient balloon inflation to dilate the artery. These aggressive procedures expose patients to increased risks, including balloon rupture in 21% of cases, vascular dissection in 76% of cases, and restenosis (i.e., re-narrowing of the vessel after the procedure) in 20–30% of cases. Other treatment strategies that attempt to break up CP include cutting BA, scoring BA, and lithotripsy BA. Cutting balloons, which are balloons surrounded by a sharp metal blade at the tip, and scoring balloons, which are balloons constrained to a metal cage, are intended to create stress concentration for CP breakup. Endovascular lithotripsy uses a low-pressure balloon with an embedded shock wave lithotripsy device. Another treatment commonly used for CP is atherectomy, a technique that uses grinding to reduce the volume of the CP. Risks from these treatments may include vascular dissection and perforation, damage to healthy tissue surrounding the lesion, and an increased risk of restenosis.

[0006] Improved techniques and methods of use for balloon angioplasty devices, including devices and systems for endovascular lithotripsy and methods of use, are still needed. [Overview of the project]

[0007] Systems, devices, and methods for treating diseased blood vessels using pulsed endovascular lithotripsy are disclosed herein. In particular, an amplifier assembly is provided. A handle assembly for controllably transmitting energy is provided. A system for delivering pulsed energy is provided, such a system including the amplifier assembly and the handle assembly. Methods for delivering pulsed energy to tissue using the assemblies and systems of the present invention are also provided.

[0008] The amplifier assembly comprises a proximal nose having a distal surface, a distal waveguide having a proximal surface, and a diaphragm sealed between the proximal nose and the distal waveguide, separating the proximal chamber from the distal chamber. In some cases, the diaphragm is compressed between the proximal nose and the distal waveguide, thereby sealing the proximal chamber from the distal chamber. In embodiments, the diaphragm is configured to translate between the distal surface of the proximal nose and the proximal surface of the distal waveguide. In embodiments, the diaphragm is configured to translate between the distal surface of the proximal nose and the proximal surface of the distal waveguide without causing distortion of the diaphragm.

[0009] The handle assembly portion for controllable energy transmission includes a coupler assembly operably connected to an energy source, a manifold operably connected to the energy source via the coupler assembly and configured to controllably transmit energy to a distal interface, and a distal interface operably connected to the output of the manifold and configured to transmit energy received from the manifold.

[0010] The system for supplying pulsed energy includes, in any case, an amplifier assembly and a handle assembly according to the present invention.

[0011] Methods for applying pulsed energy to tissue utilize assemblies and / or systems disclosed herein.

[0012] Furthermore, kits comprising amplifier assemblies, handle assemblies, and / or system components described herein are provided.

[0013] The assemblies, systems, methods, and kits are used in a variety of different applications, including balloon angioplasty.

[0014] This invention will be best understood by reading the following detailed description in conjunction with the accompanying drawings. The drawings include the following figures. [Brief explanation of the drawing]

[0015] [Figure 1A] In either case, the diagram shows a system according to one embodiment of the present invention, having an amplifier assembly connected to a handle assembly. [Figure 1B] This is an isometric view of an amplifier assembly according to one embodiment of the present invention. [Figure 1C] In both cases, the diagrams show an amplifier assembly and a handle assembly according to one embodiment of the present invention. [Figure 2A] This is an internal diagram of an amplifier assembly according to one embodiment of the present invention. [Figure 2B] This figure shows one embodiment of an amplifier assembly in which a clip is used to securely hold the diaphragm in the sealed position. [Figure 3A] This is a schematic diagram of the proximal nose of an amplifier assembly according to one embodiment of the present invention. [Figure 3B] This is a schematic diagram of the proximal nose of an amplifier assembly according to one embodiment of the present invention. [Figure 4A] This is a schematic diagram of the distal waveguide of an amplifier assembly according to one embodiment of the present invention. [Figure 4B] This is a schematic diagram of the distal waveguide of an amplifier assembly according to one embodiment of the present invention. [Figure 5A] This is a schematic diagram of the diaphragm of an amplifier assembly according to one embodiment of the present invention. [Figure 5B] This is a schematic diagram of the diaphragm of an amplifier assembly according to one embodiment of the present invention. [Figure 5C] This is a schematic diagram of the diaphragm of an amplifier assembly according to one embodiment of the present invention. [Figure 6A] This is a schematic diagram of the housing of an amplifier assembly according to one embodiment of the present invention. [Figure 6B] This is a schematic diagram of the housing of an amplifier assembly according to one embodiment of the present invention. [Figure 6C]is a schematic diagram of a housing of an amplifier assembly according to an embodiment of the present invention. [Figure 7A] is a diagram showing exemplary steps for assembling an embodiment of an amplifier assembly. [Figure 7B] is a diagram showing exemplary steps for assembling an embodiment of an amplifier assembly. [Figure 8A] is a diagram of a portion of a handle assembly according to an embodiment of the present invention. [Figure 8B] is another diagram of a portion of a handle assembly according to an embodiment of the present invention. [Figure 8C] is another diagram of a portion of a handle assembly according to an embodiment of the present invention. [Figure 8D] is another diagram of a portion of a handle assembly according to an embodiment of the present invention. [Figure 8E] is another diagram of a portion of a handle assembly according to an embodiment of the present invention. [Figure 8F] is another diagram of a portion of a handle assembly according to an embodiment of the present invention. [Figure 9A] is a diagram of a portion of a handle assembly according to an embodiment of the present invention. [Figure 9B] is another diagram of a portion of a handle assembly according to an embodiment of the present invention. [Figure 9C] is another diagram of a portion of a handle assembly according to an embodiment of the present invention. [Figure 9D] is another diagram of a portion of a handle assembly according to an embodiment of the present invention. [Figure 9E] is another diagram of a portion of a handle assembly according to an embodiment of the present invention. [Figure 9F] is another diagram of a portion of a handle assembly according to an embodiment of the present invention. [Figure 10A] is a diagram showing an overview of an embodiment of controlling software functions for a system. [Figure 10B-1]This figure shows an overview of an embodiment of controlling software functions for a system according to one embodiment of the present invention. [Figure 10B-2] This figure shows an overview of an embodiment of controlling software functions for a system according to one embodiment of the present invention. [Figure 10B-3] This figure shows an overview of an embodiment of controlling software functions for a system according to one embodiment of the present invention. [Figure 10B-4] This figure shows an overview of an embodiment of controlling software functions for a system according to one embodiment of the present invention. [Figure 10B-5] This figure shows an overview of an embodiment of controlling software functions for a system according to one embodiment of the present invention. [Figure 10C] This figure shows an exemplary graphical user interface for controlling and receiving information about a system, according to one embodiment of the present invention. [Figure 11] This figure shows the components of a system according to one embodiment of the present invention. [Figure 12-1] This figure shows a system for supplying pulsed energy according to one embodiment of the present invention. [Figure 12-2] This figure shows a system for supplying pulsed energy according to one embodiment of the present invention. [Figure 13] This figure shows the proximal nose according to one embodiment of the present invention. [Figure 14] This figure shows a distal waveguide according to one embodiment of the present invention. [Figure 15A] This figure shows a diaphragm according to one embodiment of the present invention. [Figure 15B] This figure shows a diaphragm according to one embodiment of the present invention. [Figure 16] This figure shows the proximal nose according to one embodiment of the present invention. [Figure 17A] This figure shows an amplifier assembly according to one embodiment of the present invention. [Figure 17B]This figure shows an amplifier assembly according to one embodiment of the present invention. [Figure 17C] This figure shows an amplifier assembly according to one embodiment of the present invention. [Figure 17D] This figure shows an amplifier assembly according to one embodiment of the present invention.

[0016] In drawings, elements with the same or similar reference number have the same or similar characteristics unless otherwise specified. [Modes for carrying out the invention]

[0017] A system for delivering pulsed energy according to one embodiment of the present invention is shown in Figure 1A. The system 102 includes a console 103, a CO2 tank 104, an amplifier assembly 100, a handle assembly 101, a catheter assembly 105, and a distal balloon 107. The amplifier assembly 100 and the handle assembly 101 are shown in Figure 1A as operably connected. However, the amplifier assembly 100 and the handle assembly 101 are configured to be separable from each other. For example, in certain cases, the handle assembly 101 is reusable, but the amplifier assembly 100 is disposable, so the handle assembly 101 and the amplifier assembly 100 can be separated in order to operably connect the handle assembly 101 to another amplifier assembly.

[0018] Figure 1A shows the system 102 in use. The amplifier assembly 100 is operably connected to the catheter assembly 105 relatively distal to the amplifier assembly 100. The catheter assembly 105 includes a tissue engagement element in a relatively distal region of the catheter assembly 105. The tissue engagement element of the catheter assembly 105 includes a distal balloon 107, i.e., a balloon configured to receive pressure pulses delivered from the amplifier assembly 100.

[0019] The handle assembly 101 is operably connected to the console 103 relatively proximal to the handle assembly 101. The console 103 receives energy in the form of pressurized CO2 from the CO2 tank 104 and transmits such energy to the handle assembly 101. For ease of use, the console 103 is mounted on the IV pole 106.

[0020] As described herein, the handle assembly 101 of system 102 is configured to receive energy from a pressure source, namely the CO2 tank 104 and console 103, and to transmit such energy to the amplifier 100. The amplifier assembly 100 of system 102 is configured to convert the energy received from the handle 101 and ultimately obtained from the pressure source, namely the CO2 tank 104 and console 103, into energy that is transmitted to tissue engagement elements such as the catheter assembly 105 and ultimately its distal balloon 107, thereby repeatedly pressurizing and inflating such balloon 107. Such repeated pressurization and inflation of the distal balloon 107 allows for safe and controlled fatigue fracture of the CP lesion.

[0021] An amplifier assembly is provided. Referring to Figure 2A, the amplifier assembly comprises a proximal nose 210 having a distal surface 211, a distal waveguide 260 having a proximal surface 261, and a diaphragm 270 sealed between the proximal nose 210 and the distal waveguide 260, separating the proximal chamber from the distal chamber. In the embodiment, the diaphragm 270 is configured to translate between the distal surface 211 of the proximal nose 210 and the proximal surface 261 of the distal waveguide 260 without causing distortion in the diaphragm 270.

[0022] A handle assembly for controllable energy transmission is also provided. As best shown in Figures 8A–8F and 9A–9C, the handle assembly comprises a coupler assembly 850 operably connected to an energy source; a manifold 830 operably connected to the energy source via the coupler assembly 850 and configured to controllably transmit energy to a distal interface 810; and a distal interface 810 operably connected to the output of the manifold 830 and configured to transmit energy received from the manifold 830. As described herein, the handle assembly 800 is operably connected to the amplifier assembly 200 via the distal interface 810, such as the connection between the bore 820 and the high-voltage connector 223 shown in Figure 2A.

[0023] Systems for delivering pulsed energy are also provided, and such systems in any case include an amplifier assembly and a handle assembly according to the present invention. Methods for delivering pulsed energy to tissue are also provided. Furthermore, kits comprising the components of the amplifier assembly, handle assembly, and / or system described herein are provided. The assemblies, systems, and kits are used in a variety of different applications, including balloon angioplasty applications.

[0024] The systems, assemblies, and devices of the present invention, which provide an integrated manifold system of embodiments of the present invention together or individually, may provide, or be configured to operably connect to, one or more tissue engagement elements that impart pulsed energy to internal tissue in contact with it (e.g., luminal vascular tissue such as the inner wall location of an artery), such as a distal end balloon 107 or a cardiac tissue fitting element. The energy transmitted from the amplifier assembly 200 to the balloon 107 is in the form of increasing or decreasing the pressure applied to the internal tissue in contact with it at a desired frequency and / or displacement, duty cycle, and amplitude. As used herein, frequency is the number of complete pressure pulse cycles (between peaks) per unit time, displacement is the total periodic change in the volume and / or diameter of the balloon, duty cycle is the percentage of time allocated to the high-pressure portion of a single pressure cycle, and amplitude is the difference between the maximum and minimum pressures. Since the energy imparted to the internal tissue by the balloon is pulsed, it varies (e.g., increases or decreases) at a defined or determined frequency and duty cycle. In balloon angioplasty (BA) treatment, distal blood flow may be obstructed at the distal end of the balloon, which can limit the treatment time. To ensure successful treatment 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 associated tissue can vary, sometimes being high-frequency, and sometimes in the range of 0 to 100 Hz, such as 0 to 25 Hz. Similarly, the duty cycle of the pulsed energy delivered by the balloon to the tissue may vary in some cases, in the range of 10% to 100%, for example, 60% to 80%. Changes in volume or balloon diameter depend on the patient's anatomical structure and / or the specific balloon size used in the surgery. The amplitude of the pulsed energy delivered by the balloon to the tissue may vary in some cases, in the range of 0 to 100 ATM from the balloon pressure, such as 0 to 30 ATM, during a given procedure, and the frequency may vary during the procedure, i.e., it may not be constant as desired.

[0025] Pulsed energy, when exposed to affected luminal vascular tissue, is effective in treating affected tissues such as calcified plaque (CP) tissue while reducing and / or eliminating undesirable effects on surrounding healthy tissue. Key characteristics of pulsed energy for successful treatment may include the frequency and amplitude of the pulsed energy delivered. In embodiments, such pulsed energy may enable safe and controlled fatigue fracturing of CP lesions. Fatigue fracturing is the process of periodically loading a structure at a pressure below which instantaneous shattering and / or crack propagation through the CP lesion occurs. Conventional treatments apply dangerous high-pressure bursts to blood vessels that can cause dissection and perforation of surrounding healthy tissue, whereas pulsed angioplasty uses low-pressure high-frequency vibrations within a balloon to initiate low-pressure fatigue fracturing of CP lesions.

[0026] To generate pulsed endovascular lithotripsy energy in a catheterization laboratory or clinic, a system is required to connect, monitor, and maintain various pressures with minimal or no fluid and / or gas leakage. Furthermore, the system and its assemblies must be efficiently manufacturable. In addition, the system must be sufficiently capable, reliable, and operationally functional for the end user.

[0027] Before describing the present invention in detail, it should be understood that the present invention is not limited to the specific embodiments described and can therefore vary. It should also be understood that the scope of the present invention is limited only by the appended claims, and that the terms used herein are intended solely to describe specific embodiments and are not intended to limit them.

[0028] Where a range of values ​​is provided, unless otherwise explicitly stated in the context, it is understood that each value between the upper and lower limits of that range, up to one-tenth of the lower limit, and any other listed or intermediate values ​​within that range are included in the invention. The upper and lower limits of these smaller ranges may be independently included within the smaller range, and are also included in the invention, subject to any specifically excluded limits within the listed range. If the listed range includes one or both limits, the range excluding one or both of those limits is also included in the invention.

[0029] In this specification, a specific range is presented by a number preceded by the term “approximately.” The term “approximately” is used herein to provide a literal basis for the exact number that follows, as well as for any number that is close to or approximates the number following the term. In determining whether a number is close to or approximates a specifically stated number, any number not described as close to or approximated may, in the context in which it is presented, represent a substantial equivalent of the specifically stated number.

[0030] Unless otherwise defined, all scientific and technical terms used herein have the same meaning as those generally understood by those skilled in the art to which the present invention pertains. Any methods and materials similar or equivalent to those described herein may also be used in carrying out or testing the present invention, but representative exemplary methods and materials are described herein.

[0031] All publications and patents referenced herein are incorporated herein by reference in such a way as to specifically and individually indicate that each individual publication or patent is incorporated by reference, and are incorporated herein by reference to disclose and describe the manner and / or material by which the publications are referenced. Any reference to a publication is for its disclosure prior to the filing date and should not be construed as an acknowledgment that the present invention has no prior rights to such publication by prior art. Furthermore, the publication dates presented may differ from the actual publication dates and may need to be independently verified.

[0032] It should be noted that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” refer to multiple subjects unless the context clearly indicates otherwise. It should also be noted that claims may be drafted to exclude optional elements. Therefore, this statement is intended to serve as a basis for prior art when using exclusive terms such as “alone” and “only” in connection with the enumeration of elements in the claims or the use of “negative” limitations.

[0033] As will be obvious to those skilled in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has separate components and features that can be readily separated or combined with features of any of several other embodiments without departing from the scope or spirit of the invention. Any of the listed methods may be performed in the order of the listed events, or in any other logically possible order.

[0034] Apparatus and methods are described, or will be described, using functional descriptions for the sake of fluency; however, claims should not necessarily be interpreted as being limited by constructing a limitation of “means” or “steps” unless explicitly formulated under Section 112 of the United States Patent Act, and should be given the meaning of the definitions and the full scope of equivalents provided by the claims under the doctrine of equivalents; and if the claims are explicitly formulated under Section 112 of the United States Patent Act, it should be clearly understood that a full set of statutory equivalents should be given under Section 112 of the United States Patent Act.

[0035] In further describing various aspects of the present invention, the amplifier assembly and its components are first described in more detail. Subsequently, the handle assembly and its components are described. Following this, a system for supplying pulsed energy, comprising the amplifier assembly and the handle assembly, is described. Following this, a method for using the amplifier assembly, the handle assembly, and the system, as well as an overview of a kit for practicing the subject matter, are described.

[0036] Amplifier assembly The amplifier assembly comprises a proximal nose having a distal surface, a distal waveguide having a proximal surface, and a diaphragm sealed between the proximal nose and the distal waveguide, separating the proximal chamber from the distal chamber. In some cases, the diaphragm is compressed between the proximal nose and the distal waveguide, thereby sealing the proximal chamber from the distal chamber. In some embodiments, the diaphragm is configured to translate between the distal surface of the proximal nose and the proximal surface of the distal waveguide. In some embodiments, the diaphragm is configured to translate between the distal surface of the proximal nose and the proximal surface of the distal waveguide without causing distortion of the diaphragm.

[0037] For example, in an embodiment, the amplifier assembly may be configured to operably connect a tissue engagement element, such as a distal balloon or cardiac tissue fitting element (i.e., operably connected to a catheter connected to the distal waveguide of the amplifier assembly), to an energy source, such as a pressure source (i.e., operably connected to a handle assembly connected to the amplifier assembly). In such an embodiment, the amplifier assembly is configured to convert energy originating from such a pressure source into energy to be transmitted to such a catheter and tissue engagement element, for example, in order to apply energy (e.g., pressure) to a distal balloon or cardiac tissue fitting element located in the distal region of such a catheter, i.e., to repeatedly pressurize and inflate a portion of such a balloon or cardiac tissue fitting element.

[0038] In one embodiment, the amplifier assembly comprises a diaphragm sealed between the proximal nose and the distal waveguide. In another embodiment, the amplifier assembly comprises a diaphragm held in a compressed state between the proximal nose and the distal waveguide. In one embodiment, the diaphragm separates the proximal chamber, which is located in the proximal nose, from the distal chamber, which is located in the distal waveguide. In one embodiment, the proximal chamber is defined by a first volume between the diaphragm and the distal surface of the proximal nose. In another embodiment, the distal chamber is defined by a second volume between the diaphragm and the proximal surface of the distal waveguide.

[0039] The amplifier assembly according to the present invention is configured to receive first pulsed energy from an energy source such as a potential source, e.g., a pulse generator, and convert it into second pulsed energy that can be propagated along the length of the amplifier assembly, e.g., along a fluid, e.g., a liquid, along its flow path, and ultimately to, e.g., a distal balloon or other tissue engagement element. When the amplifier assembly converts the first pulsed energy to the second pulsed energy, it changes the form of the pulsed energy in some way. Examples of changes in the form of energy that can be made by the amplifier assembly include, but are not limited to, gas pressure and / or flow to liquid pressure and / or flow, mechanical potential energy and / or kinetic energy to fluid pressure and / or flow, optical potential energy and / or kinetic energy to fluid pressure and / or flow, electrical potential energy and / or kinetic energy to fluid pressure and / or flow, magnetic potential energy and / or kinetic energy to fluid pressure and / or flow, etc. For example, if the first pulsed energy is a first pulsed energy of pneumatic pressure, the amplifier assembly may be configured to convert the first pulsed energy of pneumatic pressure into a second pulsed energy of hydraulic pressure that can propagate from the proximal end to the distal end of the amplifier assembly, which is an example of the conversion of pulsed energy from gas to liquid. In some cases, the amplifier assembly propagates the second pulsed energy from the proximal end to the distal end of the amplifier assembly with little or no attenuation, and if there is attenuation, the magnitude of that attenuation does not exceed a 30% decrease, and in some cases does not exceed, for example, 5%.

[0040] Similarly, the amplifier assembly according to the present invention is further configured to receive a first static energy from an energy source such as a potential source and convert it into a second static energy that can be propagated along the length of the amplifier assembly, for example, along the flow path of a fluid, such as a liquid, and ultimately to a distal balloon. Static energy means the application of a first pressure, such as the application of pneumatic energy maintained for a specified period of time. That is, the amplifier assembly may be configured to receive a first pressure applied to the amplifier assembly over a specified period of time.

[0041] An amplifier assembly according to an embodiment of the present invention is configured to be operably connected to a handle assembly, the handle assembly ultimately comprising an energy source for supplying a first pulsed energy or a first static energy, or being connected to an energy source itself. The amplifier assembly may be operably connected to the handle assembly using any of the various standard connectors known in the art to achieve a quick, reliable, and repeatable connection of the handle assembly to the amplifier assembly. Examples of such standard connectors include, for example, press-fit connectors, latch connectors, screw connectors, threaded connectors, magnetic connectors, push-connect connectors, yaw-lock connectors, claw-clamp connectors, gasket connectors, socket connectors, flanged connectors, cam-and-groove sockets, quick-connect connectors, etc., and optionally, aligners or stoppers may be used to provide a connection that repeatedly and accurately positions the amplifier assembly relative to the handle assembly and / or electrical connectors, i.e., the electrical connectors of the handle assembly.

[0042] The amplifier assembly may be configured to be reusable or disposable, as desired. If the amplifier assembly (or a part thereof) is reusable and may come into contact with the patient area, such an assembly may be configured to be covered with a disposable sterile sleeve or bag so that the amplifier assembly can be used without contaminating the sterile field of the operating room.

[0043] Diaphragm: As described above, the amplifier assembly of an embodiment of the present invention comprises a diaphragm sealed between a proximal nose and a distal waveguide, separating the proximal chamber from the distal chamber. In some cases, the amplifier assembly of an embodiment of the present invention comprises a diaphragm compressed between the proximal nose and the distal waveguide, thereby sealing the proximal chamber from the distal chamber. In the embodiment, the proximal nose is located in a relatively proximal region of the amplifier assembly, and the distal waveguide is located in a relatively distal region of the amplifier assembly such that the distal surface of the proximal nose substantially faces the proximal surface of the distal waveguide. In the embodiment, the proximal chamber is defined by a first volume between the diaphragm and the distal surface of the proximal nose. In the embodiment, the distal chamber is defined by a second volume between the diaphragm and the proximal surface of the distal waveguide. The diaphragm is configured to translate between the distal surface of the proximal nose and the proximal surface of the distal waveguide. As described herein, the diaphragm is configured to translate without causing any distortion to the diaphragm.

[0044] As described above, the diaphragm may be sealed between the proximal nose and the distal waveguide, separating the proximal chamber from the distal chamber. In some cases, the diaphragm may be compressed between the proximal nose and the distal waveguide, thereby sealing the proximal chamber from the distal chamber. In some embodiments, the diaphragm may include an outer ring or retaining structure configured to seal the interface between the proximal nose and the distal waveguide. In some cases, such an outer ring or retaining structure is an O-ring, such as a polymer O-ring, attached to or molded on the diaphragm. In other embodiments, such an interface may be sealed by using a clip.

[0045] In other embodiments, the diaphragm comprises an outer ring or retaining structure, which is a circumferential projection attached to or molded on the diaphragm, configured to allow the diaphragm to maintain its seal while translating between the distal surface of the proximal nose and the proximal surface of the distal waveguide, as outlined above. That is, the diaphragm may have a circumferential projection such that, as the diaphragm translates in either the proximal or distal direction, the circumferential projection is shaped to reinforce the diaphragm seal, for example, on the opposite side of the direction in which the diaphragm is translating. In some cases, the circumferential projection is a T-shaped edge or wedge.

[0046] In embodiments, the outer ring or retaining structure or circumferential projection may be separate from or molded together with the rest of the diaphragm. Such outer ring or retaining structure or circumferential projection of the diaphragm may, if desired, have any convenient geometric shape, such as a circumferential projection located on the outer circumference of the diaphragm that is substantially T-shaped, circular, or wedge-shaped, or have a geometric cross-sectional shape sufficient for mechanical retention of a gasket or ring seal subject to mechanical, pneumatic, or hydraulic stress. In embodiments, the outer ring or retaining structure or circumferential projection is shaped to fit into corresponding grooves in the proximal nose and distal waveguide. Each of these grooves may have a lip for compressing the relatively soft diaphragm material. The interaction between the grooves and the outer ring or retaining structure or circumferential projection of the diaphragm forms both an axial seal and a radial support zone to prevent diaphragm pull-out during pulsed operation, i.e., translation of the diaphragm in the proximal and distal directions.

[0047] To further reduce the pull-out force during pulsed operation, the diaphragm may be configured to translate between the distal surface of the proximal nose and the proximal surface of the distal waveguide without causing distortion to the diaphragm. For example, in embodiments, additional material may be incorporated into the diaphragm to further reduce the pull-out force during pulsed operation, allowing the diaphragm to move axially (i.e., translate distally and proximally) without forming a large pull-out force at the sealing edge of the diaphragm (e.g., the outer circumference of the diaphragm). As described herein, such additional material may be incorporated into the diaphragm via a bellows such that the bending and folding of the bellows provides material for the center of the diaphragm to translate without significantly increasing, for example, the radial force at the outer circumference of the diaphragm. In other words, the diaphragm is configured to translate between the distal surface of the proximal nose and the proximal surface of the distal waveguide without causing large distortion to the diaphragm. This reduction in radial stress reduces the tensile force on the diaphragm at its edges, i.e., its outer circumference, thereby suppressing leakage (e.g., rupture of the seal in the proximal or distal chamber) or pull-out conditions.

[0048] Some embodiments may utilize a diaphragm configured to translate proximal and distally without causing strain on the diaphragm, for example, a diaphragm with additional material such as a folding or bellows, and function as a living hinge. The diaphragm shape can be produced, for example, by conventional molding techniques, or formed by stamping, molding, or hot stamping. As the diaphragm is translated axially by an incoming pressure pulse, residual stress can be incorporated into the diaphragm design such that the diaphragm is stretched to a specified desired degree, and as a result, the diaphragm returns to its initial state, for example, a neutral or centered position. This residual stress within the diaphragm pushes the diaphragm back to its initial position, thereby creating a vacuum or negative pressure in the distal chamber during the "off" portion of the cycle.

[0049] Furthermore, by configuring the diaphragm to translate proximal and distal without causing strain to the diaphragm (for example, by utilizing a bellows configuration), the diaphragm can be operably connected to, for example, an amplifier assembly and can continuously expand to fill the required volume of an expanding distal balloon that receives the fluid delivered by the diaphragm from the distal chamber. In embodiments, in contrast to utilizing a sheet flat to the diaphragm such that relatively large radial stresses are applied to the diaphragm wall, the diaphragm is configured to be a living hinge operating within the low elastic range of the diaphragm material (i.e., the diaphragm is configured to translate proximal and distal without causing strain or substantial strain to the diaphragm). In embodiments, the diaphragm material is selected to operate within the low elastic range when shaped into the desired diaphragm configuration. Such configurations of the diaphragm in the present invention enhance the reliability of the diaphragm when exposed to high-pressure fluids.

[0050] As described above, in the embodiment, the diaphragm is configured to occupy various positions between the distal surface of the proximal nose and the proximal surface of the distal waveguide. In the embodiment, the diaphragm is further configured to translate between such various positions without causing strain on the diaphragm material. As the diaphragm translates back and forth between the distal surface of the proximal nose and the proximal surface of the distal waveguide, the diaphragm may take on different shapes to accommodate the various positions, for example, by unfolding itself to make additional diaphragm material available to accommodate the various positions without causing strain on the diaphragm. The diaphragm may be configured to fit the distal surface of the proximal nose at the proximal position of the diaphragm and the proximal surface of the distal waveguide at the distal position of the diaphragm, that is, to cover them or to cover them and lie flat. In embodiments, the diaphragm has a shape that conforms to the distal surface of the proximal nose at the proximal position of the diaphragm and to the proximal surface of the distal waveguide at the distal position of the diaphragm. For example, in some cases, the diaphragm includes a fold or pleat or pleated bellows. That is, the diaphragm has a shape such that additional material becomes available (i.e., unfolded) when the diaphragm is extended to a relatively more proximal or more distal position, or it may be otherwise configured in this way. Such a diaphragm may be further configured such that such additional material folds back over itself when the diaphragm returns to a relatively neutral position.

[0051] In some embodiments, the diaphragm has a shape that fits into recesses on the distal surface of the proximal nose and recesses on the proximal surface of the distal waveguide when the diaphragm is substantially fully extended. For example, the diaphragm may have folds located on the diaphragm such that additional material unfolds into corresponding curves or other shapes on the distal surface of the proximal nose or the proximal surface of the distal waveguide, both of which are configured to receive such additional material of the diaphragm. That is, the straight length of the diaphragm is configured such that, in its extended position, the diaphragm fits into the surface of the distal surface of the proximal nose or the surface of the proximal surface of the distal waveguide at either the proximal or distal end, thereby minimizing unused space or residual gas that could lead to a decrease in the efficiency of maximum pulse transmission.

[0052] As described above, the diaphragm is configured to translate between the distal surface of the proximal nose and the proximal surface of the distal waveguide without causing strain to the diaphragm. Not causing strain to the diaphragm means, for example, not causing tension to the diaphragm, or stretching the diaphragm material, or there is no resistance from the diaphragm material, or no stress is applied to the diaphragm material. In embodiments, not causing strain to the diaphragm means not causing a substantial, significant, substantial, undesirable, or unexpected amount of strain to the diaphragm, for example, strain that may be sufficient to cause the diaphragm to leak from between the proximal nose and the distal waveguide, or to move out of its position.

[0053] As described above, the diaphragm is configured to separate the proximal and distal chambers, to translate in response to the first pulsed energy, and thereby generate a second pulsed energy in the distal chamber of the amplifier assembly. The dimensions of the diaphragm may vary, and in some cases, the diaphragm may be 500 mm 2 ~2000mm 2 , or 400mm 2 ~800mm 2such as 100mm 2 ~5000mm 2 The diaphragm has an area within the range of . The diameter of the diaphragm when in a fully neutral or folded state may vary, and in some cases the diaphragm has a folded diameter in the range of 10 mm to 75 mm, such as 20 mm to 50 mm, or 10 mm to 40 mm. The diaphragm may be manufactured from any convenient material, and in some cases the material is substantially non-elastic, i.e., not flexible. In some cases the material has a hardness in the range of Shore 10A to Shore 90A, or Shore 30A to Shore 90A, such as Shore 50A, and a thickness of 0.5 mm to 5 mm, such as 1.0 mm to 2.5 mm. Examples of suitable diaphragm materials include, but are not limited to, silicone, rubber, urethane, synthetic or natural polymers, elastomers, fabrics, woven fibers, and nonwoven fibers. In some cases, the diaphragm material may be reinforced by adding reinforcing components such as embedded fibers, surface coatings, adhesives, internal or external structures, hardware, hinges, wires, cables, or additional layers of the same composition, e.g., additional layers of material. If necessary, biasing components such as springs may be provided to provide a default or reference diaphragm position and / or shape and / or configuration. For example, a spring may be provided on the distal chamber side of the diaphragm, which pushes the diaphragm back to its initial position and / or shape and / or configuration when the force is removed from the proximal chamber side of the membrane.

[0054] As outlined above, in the embodiment, the diaphragm is a flexible, impermeable membrane that converts pulsed pneumatic pulses (i.e., from the proximal chamber) into pulsed fluid pulses (i.e., from the distal chamber). In one embodiment, the diaphragm also separates the proximal chamber (i.e., the pneumatic chamber) from the distal chamber (i.e., the distal fluid chamber). Furthermore, the diaphragm is configured to ensure a proper and reliable seal between the internal chamber and the atmosphere.

[0055] In the embodiments, applying pulsed energy between the proximal and distal chambers requires longitudinal motion of the diaphragm from the proximal to the distal position (i.e., translating the diaphragm distally and proximally). The diaphragm of the present invention is configured such that such longitudinal motion produces at least two effects: (1) a “water hammer” effect of pulsed energy applied to the fluid in the distal chamber and, ultimately, to tissue engagement elements operably connected to the amplifier assembly, such as a distal balloon that is ultimately operably connected to the amplifier assembly, and also to the surrounding tissue; and (2) a continuous increase in the volume supplied to such distal tissue engagement elements, such as increasing the volume in the distal balloon as the tissue surrounding the tissue engagement element, for example, the distal balloon, softens (i.e., as calcium deposits fatigue and / or crack).

[0056] proximal nose As outlined above, the amplifier assembly of an embodiment of the present invention comprises a proximal nose having a distal surface. In the embodiment, the amplifier assembly is configured such that a diaphragm separating a proximal chamber from a distal chamber is sealed between the proximal nose and the distal waveguide, and the diaphragm is further configured to translate between the distal surface of the proximal nose and the proximal surface of the distal waveguide. In the embodiment, the diaphragm is compressed between the proximal nose and the distal waveguide, thereby sealing the proximal chamber from the distal chamber. In the embodiment, the diaphragm translates between the distal surface of the proximal nose and the proximal surface of the distal waveguide without causing distortion of the diaphragm.

[0057] The morphology of the proximal nose may vary in shape. In some cases, the proximal nose is substantially cylindrical. In some cases, the shape of the proximal nose includes a collar on a relatively proximal side and / or another collar on a relatively distal side. In certain cases, the proximal nose has a central region on one relatively distal side that forms a proximal chamber and on the opposite, other relatively proximal side that forms a proximal interface with the high-voltage connector. In embodiments, the proximal nose may have any convenient diameter, such as a diameter in the range of 2.5 mm to 100 mm, such as 5 mm or 50 mm, and any convenient length, such as a length in the range of 50 mm to 500 mm, such as 100 mm or 250 mm (i.e., length along the long axis of the amplifier assembly). In embodiments, the proximal nose may be formed from any convenient material. For example, the proximal nose may be molded plastic, rubber, ceramic, or metal, and in some cases a dissimilar material may be molded, mechanically attached, or bonded to the proximal nose material, for example, molded, mechanically attached, or bonded to the end of the plastic, metal, or rubber proximal nose. Where present, the dissimilar material may be overmolded to associate, bond, or combine with the proximal nose material. For example, a dissimilar material may be overmolded so that a cooling plastic element shrinks onto a metal insert regardless of the direction of cooling.

[0058] In the embodiment, the proximal nose is shaped to form a proximal chamber, which is a geometric cavity within the proximal nose, where a high-pressure pneumatic fluid, such as air or a high-pressure gas such as CO2, expands as it exits the high-pressure connector (as described herein) and collides with the proximal side of the diaphragm. This interaction displaces the diaphragm distally, forming a pneumatic pulse. The shape of the proximal chamber (also referred to in the embodiment as the pneumatic amplifier cavity) minimizes the volume of the pneumatic pulse so that the pressure can be rapidly increased while maximizing the area receiving the pressure pulse (i.e., the area of ​​the diaphragm). This allows for the generation of efficient pulses with minimal waste of fluid (e.g., high-pressure gas). Furthermore, the geometric shape of the proximal chamber prevents oversaturation and maintains the linear output of the frequency and displacement sensors during use of the amplifier assembly.

[0059] In embodiments, the proximal nose is shaped to include a groove such as a ring (i.e., a ring around the outer circumference) which is a toroidal groove (for example, in some cases, such a groove is configured to receive an O-ring attached to the diaphragm) capable of receiving the circumferential projection of the diaphragm described herein. The groove may have radially arranged concave geometric retaining structures that control the position and deformation / compression of the circumferential projection of the diaphragm (e.g., an O-ring attached thereto). Once the circumferential projection of the diaphragm is seated, the groove maintains the seal by preventing the diaphragm from coming out of the groove as the diaphragm is periodically subjected to various pressures and displacements.

[0060] In some cases, the proximal nose includes a proximal interface located in the proximal region of the proximal nose. The proximal interface means the proximal side or proximal surface of the proximal nose. In some cases, the proximal interface is configured to interface with the handle assembly. In embodiments, the proximal interface includes a high-voltage connector, i.e., a connector fluidized to the proximal chamber, so that the amplifier assembly can receive energy generated by an energy source operably connected to the amplifier assembly via the handle assembly, such as high-pressure air or a high-pressure fluid such as CO2, or a first pulsed energy or pneumatic pulsed energy or static energy, and the handle assembly interfaces with the amplifier assembly at the proximal interface via the high-voltage connector.

[0061] In some embodiments, the high-voltage connector is substantially cylindrical. In some embodiments, the connection between the amplifier assembly and the handle assembly is achieved via a high-voltage connector, which is a connector tube or nozzle, that is either part of the manufactured proximal nose or added to the proximal nose, i.e., a separate component. When the high-voltage connector is added to the manufacture of the proximal nose, the high-voltage connector material may be a metal, i.e., a metal part molded into the plastic of the proximal nose, such as stainless steel, coated or uncoated aluminum, plated or unplated brass, copper, or similar corrosion-resistant material. The dimensions of the high-voltage connector may vary as desired, but in some cases, the high-voltage connector has an outer diameter in the range of 1 mm to 30 mm, such as 3 mm to 8 mm, and an inner diameter in the range of 1 mm to 30 mm, such as 2 mm to 7 mm. When the proximal nose has a high-voltage connector, the high-voltage connector may have a length in the range of 1 mm to 50 mm, such as 3 mm to 10 mm.

[0062] If the proximal nose includes a high-pressure connector, the proximal chamber of the proximal nose is fluidically coupled to the high-pressure connector. In such cases, the junction between the high-pressure connector and the proximal chamber may include a nozzle and / or diffuser, which may optionally be geometrically shaped by the proximal nose. In such cases, the nozzle or diffuser may act to increase or decrease the flow velocity of the fluid (e.g., high-pressure gas) within it at the expense of fluid pressure. Such increases or decreases in fluid velocity may improve the characteristics of energy conversion (i.e., from a first pulse energy to a second pulse energy, between a first energy applied to the proximal chamber and a second energy applied to the distal chamber), such as the rise time or smoothness of the energy conversion. In the case of airflow, the gas velocity may be high enough to cause compressible fluid phenomena such as sonic or supersonic flow. In such cases, special flow nozzles, such as convergent-divergent nozzles, may be used to optimize the flow velocity.

[0063] In the embodiment, the high-voltage connector includes an O-ring groove configured to receive an O-ring. Such a groove and associated O-ring may be included on the high-voltage connector, i.e., between the high-voltage connector and the handle assembly, to form a reliable seal. The O-ring groove may be located in the proximal region of the high-voltage connector and may include a grooved retaining structure for one or more O-rings. Such a groove may be located in the proximal region of the high-voltage connector and may have any convenient dimensions, i.e., any convenient depth and width, which may vary. Thus, any convenient O-ring, such as a polymer O-ring, can be installed based on the corresponding dimensions of the O-ring groove. In the embodiment, the high-voltage connector and the O-ring held on or within the high-voltage connector are inserted into a mating socket, i.e., a mating socket of the handle assembly, which forms a reliable high-voltage seal.

[0064] In other embodiments, such reliable high-pressure seals are formed via face seals, for example, where a sealing gasket is pressed against a smooth surface of a handle assembly to form a secure seal. Additional embodiments may include non-polymer O-rings or gaskets, compression / expansion fittings for tubes or pipes, push-connect pneumatic plugs and socket receptacles, medical Luer-type connectors or other connectors, and / or combinations thereof.

[0065] In some embodiments, the proximal interface includes an alignment structure, such as a keyed facet. Such an alignment structure, such as a keyed facet, may be used to align the proximal interface of the proximal nose with the handle assembly when operably connecting them. For example, the keyed facet may control the rotational, axial, and radial positions of the amplifier assembly relative to the mating receptacle of the handle assembly. Furthermore, a keyed facet means that the proximal interface includes one or more structures that are possibly rotationally asymmetrical, such that the keyed facet allows the proximal interface to interface with the handle assembly in only one rotational orientation (i.e., around the long axis of the amplifier assembly or an axis perpendicular to the handle assembly). The keyed facet may be used to align the proximal nose with the handle assembly so that the elements of each assembly are aligned when operably connected. For example, the amplifier and handle assemblies may require alignment so that the electrical connectors on each assembly are properly aligned with each other. For example, any convenient keying mechanism, such as a grooved stopper, an asymmetric channel, an elongated shape, and a rectangular prism, may be used on the proximal interface of the proximal nose. Such elements may have any convenient dimensions as desired. Furthermore, internal structures such as slots or grooves may be used to further restrict the position of the interlock structure of the amplifier assembly. A backstop element may be used to set the axial depth of the amplifier assembly within the receptacle of the handle assembly. These structures may act alone or in cooperation to restrict the rotational, axial, and radial positions of the amplifier assembly within the receptacle of the handle assembly.

[0066] In certain embodiments, the handle assembly and amplifier assembly may include one or more sensors configured to verify that the amplifier assembly and handle assembly are connected. In some cases, such sensors are configured to indicate that the handle assembly and amplifier assembly are operably connected or connected in an expected or specified orientation or configuration. In some cases, the handle assembly and amplifier assembly may be configured to include displacement sensors configured to verify that the distance between the handle assembly and the amplifier assembly and / or their orientations are as expected or specified. The handle assembly and amplifier assembly may also include a Hall sensor configured to function as a connect / disconnect switch. In certain cases, the Hall sensor may include a magnet located on the handle assembly and a probe located on the amplifier assembly, or a probe located on the handle assembly and a magnet located on the amplifier assembly. In other cases, the magnet may be located on each of the handle assembly and amplifier assembly, and the probe may be located on either the handle or the amplifier assembly. If present, the Hall sensor may be calibrated to measure distances between parts of the handle assembly and amplifier assembly, such as the distance between the distal interface of the handle assembly and the proximal face of the amplifier assembly. In the embodiment, the handle assembly is configured with one or more interlocks to prevent the Hall sensor from transferring energy (for example, to the distal interface of the handle assembly) when it cannot confirm that the handle assembly and the amplifier assembly are operably connected.

[0067] In embodiments, the proximal nose is shaped to include a flexible electronics housing to which a portion of an electrical assembly, as described herein, is mounted. In some cases, the proximal nose is shaped to further include a guide for mounting the portion of the electronics assembly. That is, in embodiments, the flexible electronics housing and guide position the electronics assembly or portion, such as a flexible printed circuit board, so that a repeatable connection can be made between the electronic connector (i.e., electrical connector) of the amplifier assembly and the corresponding connector of the handle assembly. Such guide portions of the proximal nose may be used to position and connect portions of the electronics assembly, such as a flexible printed circuit board, during assembly and use, for example, to prevent the flexible circuit board or other components from being pinched or damaged.

[0068] In some embodiments, the proximal nose may be shaped to include a housing retention structure. Such a structure positions one or more portions of the housing (as described herein) relative to the proximal nose. Such a structure may also be used to lock, i.e., hold, the housing in its final position. In some embodiments, the housing retention structure may be a fitting groove or ridge, a nub, or a clearance, press-fit, or pin / screw hole, etc. In other embodiments, the proximal nose is configured to include a distal waveguide positioning guide. If present, the distal waveguide positioning guide is a structure of the proximal nose that positions the distal waveguide during assembly to ensure that the distal waveguide is assembled relative to the proximal nose in a desired position and orientation (for example, the proximal nose is shaped to include such a positioning guide).

[0069] In some cases, the proximal nose is further configured to include a distal waveguide holding zone or holding structure. If included, such a holding zone is a set of structures that ensure proper compressive loads on the distal waveguide and diaphragm during assembly with the proximal nose. Such structures further fix the distal waveguide in place once positioned and / or oriented as desired. In some embodiments, the distal waveguide holding zone is a set of holes for receiving hardware such as pins, screws, bolts, configured to control and lock the compressed distance of the amplifier assembly, i.e., to control and lock the positions of the proximal nose, distal waveguide, and the diaphragm compressed between them. In other embodiments, the distal waveguide holding zone is a set of deflection and interlocking structures that, once fitted, prevent the distal waveguide from coming out of the proximal nose (and with the diaphragm compressed between the proximal nose and the distal waveguide). Such other structures may include, for example, a cable tie-like mechanism or other unidirectional ratchet mechanism. In other embodiments, the distal waveguide holding zone represents a location for thermal crimping, thermal deformation, laser welding, or ultrasonic welding, i.e., a location for fixing the distal waveguide to a certain location relative to the proximal nose, with the diaphragm compressed between them. In other embodiments, the holding structure may comprise a structure positioned at a selected location on the proximal nose corresponding to a specific location on the distal waveguide when the proximal nose and distal waveguide are brought out together, for example, a relatively distal location on the distal waveguide or a relatively proximal location on the distal waveguide or a combination thereof. Such a holding structure may comprise any convenient adhesive, for example, so that the holding structure distributes the compressive load from the distal waveguide to the proximal nose. In certain embodiments, the holding structure comprises potting an area such as the distal or proximal region of the assembly with adhesive. Such adhesive potting may partially distribute the compressive load from the distal waveguide to the proximal nose.

[0070] As described herein, the proximal nose of the subject, and the handle assembly operably connected thereto, can receive a fluid, in particular a fluid that is subject to pressure oscillations during use. In embodiments, the fluid (e.g., a gas) is introduced into the proximal nose via the handle assembly, and such a fluid is subject to pressure oscillations. Any suitable fluid, or conditions in which the fluid / gas is evacuated and absent, such as a vacuum or a fluid at very low pressure, may be applied, and these may vary. If such a fluid is a gas, the gas of the subject may include air or CO2 or nitrogen, helium, nitrous oxide, argon, water vapor, phase change refrigerant, or coolant, and in each case, the gas may be sterile.

[0071] distal waveguide As outlined above, the amplifier assembly of the embodiment of the present invention comprises a distal waveguide having a proximal surface. In the embodiment, the amplifier assembly is configured such that a diaphragm separating the proximal chamber from the distal chamber is sealed between the proximal nose and the distal waveguide. In other embodiments, the amplifier assembly is configured such that the diaphragm is compressed between the proximal nose and the distal waveguide, thereby sealing the proximal chamber from the distal chamber, and the diaphragm is further configured to translate between the distal surface of the proximal nose and the proximal surface of the distal waveguide.

[0072] The shape of the distal waveguide may vary depending on the embodiment, and in some examples the distal waveguide is substantially conical or substantially cylindrical. In some cases the shape of the distal waveguide comprises a relatively proximal portion that is substantially conical and a relatively distal portion that is substantially cylindrical. In certain cases the distal waveguide comprises a region that forms a distal chamber on the relatively proximal side opposite the relatively distal catheter interface and is fluidly connected to the relatively distal catheter interface. In embodiments, the distal waveguide may have any convenient diameter, i.e., a maximum diameter such as a diameter in the range of 10 mm to 100 mm, such as 25 mm or 50 mm, and any convenient length such as a length in the range of 25 mm to 250 mm, such as 50 mm or 75 mm (i.e., length along the long axis of the amplifier assembly). In embodiments, the distal waveguide may be formed from any convenient material. For example, the distal waveguide may be molded plastic, rubber, ceramic, or metal, and in some cases, a dissimilar material may be molded, mechanically attached, or bonded to the material of the distal waveguide, for example, molded, mechanically attached, or bonded to the end of the plastic, metal, or rubber of the distal waveguide.

[0073] Embodiments of the distal waveguide are shaped to include a fluid path that begins distal to the diaphragm and includes the distal chamber of the distal waveguide as well as a catheter interface (as described herein). Such a fluid path may, after exiting the distal waveguide, continue through a flexible tube, a Y-hub, a catheter, and ultimately to a balloon. This fluid path is filled with fluid (e.g., saline, a mixture of saline and contrast agent, or other fluids or fluid mixtures commonly used in interventional procedures, i.e., cardiovascular interventions) to form a fluid column. This fluid column is pulsed by a hydrostatic shock or hydro hammer effect, which transmits pressure waves from the distal end of the distal waveguide to a tissue engagement element, such as a distal balloon operably connected to the amplifier assembly via a catheter. Subsequently, a volume change occurs in such a distal balloon, resulting in a pulsed effect. As the calcium cracks and the affected vessel becomes more compliant, the diaphragm of the amplifier assembly delivers more fluid volume to the tissue engagement element, e.g., the distal balloon.

[0074] In some embodiments, the distal waveguide has a funnel-shaped geometry configured to guide pressure waves into the fluid channel. Such a configuration of the distal waveguide also helps to ensure that the distal side of the diaphragm is supported and prevents rupture in the event of rapid inflation or rupture of a balloon operably connected to the amplifier assembly. In embodiments, the internal bell shape of the distal waveguide provides a defined maximum volumetric expansion that limits displacement and elastic stress on the diaphragm. The distal waveguide may also be configured to help ensure a smooth transfer of flow vectors from the diaphragm to the fluid channel, for example, by having an internal shape that helps to ensure a smooth transfer of flow vectors from the diaphragm to the fluid channel, i.e., the catheter interface, while minimizing such flow turbulence.

[0075] Similar to the proximal nose described herein, the distal waveguide may be shaped to include a groove that is a ring (i.e., a ring around the outer circumference) which is a toroidal groove (in some cases, such a groove is configured to receive an O-ring attached to the diaphragm) capable of receiving the circumferential projection of the diaphragm described herein. The groove has a radially arranged concave geometric retaining structure that controls the position and deformation / compression of the circumferential projection of the diaphragm (e.g., an O-ring attached thereto). When the circumferential projection of the diaphragm is seated in such a groove of the distal waveguide (and the corresponding groove of the proximal nose), the groove maintains the seal by preventing the diaphragm from coming out of its compressed position and configuration between the distal waveguide and the proximal nose as the diaphragm is periodically subjected to various pressures and displacements.

[0076] In one embodiment, the distal waveguide includes a portion having a funnel-shaped geometric form that guides the pressure wave into the fluid channel. The distal waveguide also ensures that the distal portion of the diaphragm is supported in the event of rapid balloon expansion or rupture, thereby preventing rupture. The shape of this distal waveguide ensures a smooth transmission of the flow vector from the diaphragm to the fluid channel while minimizing flow turbulence.

[0077] In embodiments, the distal waveguide includes a catheter interface located in the distal region of the distal waveguide. A catheter interface means an interface that provides fluid connectivity to the distal waveguide and is configured to be attached, for example, to a catheter, i.e., a catheter assembly. The distal waveguide is configured such that a fluid present in the distal chamber, such as saline, can be biased via the catheter interface by a diaphragm to, for example, a distal balloon or other tissue engagement element operably connected to the output of an amplifier assembly. That is, when the amplifier assembly receives energy generated by an energy source operably connected to the amplifier assembly, such as a first pulsed energy or pneumatic pulsed energy or static energy, and converts such energy into a second pulsed energy or static energy in the distal chamber, such second energy or second pulsed energy (e.g., a high-pressure fluid such as a high-pressure fluid containing saline) can be transmitted from the distal chamber to the catheter interface. In embodiments, the catheter interface is in fluid communication with the distal chamber. In some cases, the catheter interface includes a Luer lock, such as a floating Luer lock. The dimensions of the catheter interface may vary as desired, but in some cases, the catheter interface has an outer diameter in the range of 2 mm to 20 mm, such as 5 mm to 10 mm, and an inner diameter in the range of 1 mm to 10 mm, such as 4 mm to 8 mm. In such cases where the distal waveguide has a catheter interface, the catheter interface may have a length in the range of 2.5 mm to 25 mm, such as 4 mm to 12 mm.

[0078] Embodiments of the distal waveguide further include a holding zone, which is a zone on the distal region of the distal waveguide configured to hold the distal waveguide against the proximal nose (e.g., hold it inside or be compressed against it) after a suitable compression depth (i.e., suitable compression of the diaphragm between the proximal nose and the distal waveguide) has been established (i.e., may be shaped to include it). In some embodiments, the holding zone is used to distribute the load from pulsed pressure waves of the amplifier assembly across the entire distal surface of the distal waveguide. In other embodiments, the holding zone is the location for thermal crimping, ultrasonic welding, potting, or other techniques for joining the proximal connector nose and the distal waveguide.

[0079] In some embodiments, the amplifier assembly further comprises a pin, such as a steel pin, which is a retaining pin configured to hold the distal waveguide in a sealed engaged state with the diaphragm and proximal nose. In embodiments, the distal waveguide is shaped such that a pin can be positioned on the distal side of the distal waveguide to apply force in a relatively proximal direction. In embodiments, such a pin may be positioned through a hole or slot in the distal collar of the proximal nose, i.e., the distal side of the distal waveguide, so that the pin abuts the distal side of the distal waveguide.

[0080] In embodiments, the distal waveguide is shaped to include a guide for mounting a part of an electronic equipment assembly. That is, in embodiments, the flexible electronic equipment guide positions and / or protects an electronic equipment assembly or part of it, such as a flexible printed circuit board, so that it can be connected to various components of an amplifier assembly and / or so that a repeatable connection can be made between the electrical connector of the amplifier assembly and the corresponding connector of the handle assembly. Such a guide portion of the distal waveguide may be used to position, connect and / or protect a part of an electronic equipment assembly, such as a flexible electronic device, during assembly and use, for example, to prevent the flexible circuit board or other components from being pinched or damaged.

[0081] As described herein, the distal waveguide may ultimately be operably connected to a distal balloon or other tissue engagement element via, for example, a Luer lock connected to a flexible tube, a Y-hub connector, and one or more catheters. In embodiments, the Luer lock portion is connected to a flexible tube that connects to the Y-hub of the catheter. Such components partially function as strain relief between the amplifier assembly and the catheter. Such components are configured to transmit pulsed pressure waves between the amplifier assembly and the catheter, ultimately to the distal balloon or other tissue engagement element.

[0082] As described herein, the distal waveguide of interest, and the catheter operably connected thereto, can accept a fluid, in particular a fluid that is subject to pressure oscillations during use. In embodiments, the fluid (e.g., a liquid) is introduced into the distal waveguide, for example, via a microcatheter or other assembly fluid-connected to the distal waveguide, and such liquid is subject to pressure oscillations. Any convenient fluid may be applied, and such fluids may vary. If such fluid is a liquid, the fluid of interest comprises water or saline, with or without contrast agents or other radiopaque liquids or fluorocarbons or perfluorocarbons, and in each case, the liquid may be sterile. Other fluids of interest include iodine-based fluids, barium sulfate, gadolinium, or other radiocontrast agents, and in each case, the liquid may be sterile.

[0083] Electrical Assembly In embodiments, the amplifier assembly further comprises an electrical assembly (also called an electronics assembly) integrated with one or more of the proximal nose, distal waveguide, and diaphragm. The electrical assembly may be configured to perform a variety of functions as desired, including, for example, supplying power to various sensors in or outside the amplifier assembly, controlling such sensors, receiving data from such sensors, recording and / or transmitting such data to another location, e.g., wirelessly, controlling various parts of the amplifier assembly or parts outside the amplifier assembly, and / or storing information about the amplifier assembly or the handle assembly to which it is connected or other parts of the system to which the amplifier assembly is connected.

[0084] In some cases, the electrical assembly includes a controller programmed to perform, for example, self-check routines and / or self-diagnostic routines to verify the safety of the amplifier assembly. In one embodiment, the electrical assembly is a flexible printed circuit board and is configured to perform several functions, for example, forming electrical connections to a handle assembly, measuring the pressure of fluid in a distal chamber using sensor readings, measuring the position of the center of a diaphragm using sensor readings, storing catheter, balloon (or other tissue engagement element), and / or other treatment-specific information in memory, or reading such information from memory.

[0085] The electrical assembly may vary and may include circuits and / or memory. If present, the memory may store various different types of information, including, but not limited to, information about the amplifier assembly and / or its components, or components to which it is operably connected, such as a handle assembly, or, for example, a distal balloon (or other tissue engagement element), or related information, such as expiration date, batch number, balloon size (e.g., balloon diameter and length), balloon rated burst and nominal pressure, cycle limit (e.g., allowable number of cycles for the balloon rating), and number of cycles used, allowable pulse frequency or duration, previous use, balloon reference pressure-volume curve, and / or usage adaptation.

[0086] The electrical assembly may exist in any convenient configuration, such as a printed circuit board including a flexible printed circuit board. In some cases, the electronic assembly may transmit data wirelessly, such as via Bluetooth® RF. In the example, the electrical assembly comprises one or more microprocessors, such as one or more microcontrollers. The microprocessors in question include commercially available processors, such as general-purpose or other dedicated processors, controllers, microcontrollers, application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), dedicated digital circuits, and / or analog circuits or other logic circuits. Such microprocessors may comprise one or more memories. The memories in question include commercially available memories, such as volatile and non-volatile memory storage chips, devices, or systems. The electrical assembly may be mounted, as desired, on a proximal nose or distal waveguide or other part of the amplifier assembly.

[0087] The electrical assembly, if present, may further include connectors for operably connecting the electrical assembly to the handle assembly. In embodiments, the electrical assembly comprises a plurality of electrical connectors integrated into the proximal interface. The number of electrical connectors may vary as desired. Any convenient form of electrical connector may be used. For example, the proximal interface may be configured such that the electrical connectors make electrical connections by connecting elements oriented perpendicular to the long axis of the amplifier assembly. In some cases, the electrical connector comprises a plurality of ball connectors, i.e., a plurality of plates configured to interface with the ball connectors of the handle assembly. The electrical connector may also comprise a ground plate extending along the entire length of the plurality of electrical connectors, i.e., the ground connection is consequently the first electrical connection made, for example, with the corresponding electrical connector of the handle assembly, and the last electrical connection to be disconnected, for example, from the corresponding electrical connector of the handle interface. The electrical connectors may be used in any convenient manner, which may vary, including, for example, power connections, ground connections, and connections for transmitting and / or receiving data and / or control signals.

[0088] pressure sensor Embodiments of the amplifier assembly further include a pressure sensor configured to sense the fluid pressure in the distal waveguide. The pressure sensor may be configured to sense the pressure ultimately output by the amplifier assembly, for example, via a catheter interface in the distal waveguide. The pressure sensor may be configured to sense the pressure applied to a distal balloon operably connected to the amplifier assembly, for example. In some cases, the amplifier assembly includes a pressure sensor operably coupled to the distal chamber. In such cases, the pressure sensor may detect the pressure in the fluid in the distal chamber and any changes thereto. Any convenient type of pressure sensor may be present, if included, and examples of pressure sensors that may be present include, but are not limited to, resistive, capacitive, piezoelectric, optical, and MEMS-based pressure sensors.

[0089] In the embodiment, the pressure sensor is integrated into the distal waveguide. For example, the distal waveguide may be shaped to include a fluid connection and / or mounting for the pressure sensor at a position relatively distal to the distal chamber. In the embodiment, the pressure sensor is electrically connected to an electrical assembly, such connection performs functions such as supplying power to the pressure sensor, receiving output signals from the pressure sensor, or controlling the pressure sensor.

[0090] Some embodiments of the distal waveguide include a pressure sensor receptacle used to house a pressure sensor. The pressure sensor may be fixed to the distal waveguide by adhesive, heat crimping, ultrasonic welding, internal O-ring seal or O-ring face seal, set screw with interference fitting, or other sealing method.

[0091] In other embodiments, the pressure sensor may be mounted on a distal Luer lock that is operably connected to a distal waveguide via a T-junction on the Luer lock.

[0092] Position / Volume Sensor Embodiments of the amplifier assembly further include a sensor configured to sense the position of the diaphragm. The diaphragm position means the position of the diaphragm in a relatively distal or proximal direction relative to the neutral center of the diaphragm. The diaphragm position also means the position of the central region of the diaphragm. Furthermore, the diaphragm position means the position of the diaphragm indicating the amount of fluid biased from the output of the amplifier assembly (e.g., from the catheter interface of the distal waveguide) and, for example, to a distal balloon or other tissue engagement element operably connected to the output of the amplifier assembly.

[0093] In other words, in some cases, the amplifier assembly includes a position sensor configured to provide spatial data relating to the position of the diaphragm at a given time, for example, while the amplifier assembly is in use or while the system in which the amplifier assembly is part is in use. Any convenient position sensor, if present, may be used. In some cases, the diaphragm position sensor is a Hall sensor and may be used in combination with one or more magnets (e.g., permanent magnets or electromagnets) or two or more magnets located at fixed positions relative to the diaphragm, such as at fixed positions on the amplifier assembly or handle assembly, so that the fixed magnets are positioned to modulate the voltage of the Hall sensor as the diaphragm moves (i.e., translation of the diaphragm in the proximal and distal directions).

[0094] For example, the position sensor may comprise a first magnet integrated into the proximal nose, a second magnet integrated into the distal waveguide at a specified distance from the first magnet, and an electrical probe located in the central region of the diaphragm. In such a case, the electrical probe is configured such that the movement of the diaphragm relative to the first and second magnets causes a detectable change in current or voltage in the probe located in the central region of the diaphragm, for example, indicating the position of the diaphragm.

[0095] In some cases, the proximal nose comprises a first receptacle configured to hold a first magnet in a fixed position, and / or the distal waveguide comprises a second receptacle for holding a second magnet in a fixed position. In embodiments, the first and second magnet receptacles provide positions for fixing the magnets in desired positions. To hold the magnets without requiring additional holding mechanisms or processes, deformation structures molded into the proximal nose and distal waveguide may be used. The deformation structure may comprise, for example, crush ribs or other protrusions designed to hold the magnets in a fixed position. Furthermore, a rear stop limiting structure may be used to position the depth of the magnets relative to other elements (e.g., displacement and frequency sensors). That is, embodiments may include structures such as specific shapes for constraining the position of one or more magnets relative to other elements of the system, or for otherwise precise positioning. In embodiments, the magnetic field of one or more magnets induces electrical activity or characteristics on a Hall sensor or probe, such as current and / or voltage changes. One or more such changes in electrical activity or characteristics are directly related to the distance from the magnetic field pole to the Hall sensor or probe. Such electrical activity or characteristics can be calibrated to directly measure diaphragm displacement and indirectly measure volume changes (e.g., changes in the volume of the fluid being delivered, e.g., changes in the volume of the proximal and / or distal chambers).

[0096] In some cases, the proximal nose and / or distal waveguide are shaped such that the first and second receptacles have crush ribs, i.e., compressible protrusions or projections, which in turn hold the magnet within the receptacle under tension. In some embodiments, an electrical probe located in the central region of the diaphragm is electrically connected to an electrical assembly, for example, to power the sensor and / or receive data from the sensor and / or control the sensor. In other embodiments, the position sensor comprises integrating the magnet into the central region of the diaphragm.

[0097] In other examples, the position sensor may be an optical sensor, a potential sensor, a resistance sensor, a magnetic sensor, an angle sensor, or an acceleration sensor. Furthermore, any combination of these sensors may be used to collect position data of the diaphragm. For example, if a combination of membrane position sensors is used to ensure that the sensors provide accurate data over various frequencies, the sensor data may be combined via a “sensor fusion” technique, such as those known in the art. Where present, the position sensor may be used for a variety of different purposes, such as evaluating vascular compliance and treatment, evaluating proper filling of a balloon operably connected to the output section of an amplifier assembly, or providing a method for evaluating whether the diaphragm has stretched beyond a desired threshold. Methods for manufacturing the position sensor may include, but are not limited to, bonding, direct printing, welding, and embedding.

[0098] As described above, in relation to the inclusion of a position sensor (e.g., a Hall sensor) in one embodiment of the amplifier assembly, the diaphragm may be configured to include a flexible electronic guide and a position sensor holding zone in which such a portion interacts with the electronic assembly. In some embodiments, the portion of the position sensor (e.g., a Hall sensor or Hall sensor probe) is mounted at the center of the diaphragm and provides an electronic output (e.g., a voltage output) corresponding to the position at the center of the diaphragm. The position at the center of the diaphragm corresponds to the volume output of the amplifier assembly provided by the sensor.

[0099] Parts of the position sensor and / or electronic assembly (e.g., a flexible circuit board) may have thin, rigid plates that are difficult to seal, making it difficult to prevent fluid from escaping from the proximal and / or distal chambers. To form a seal without damaging the parts of the electronic assembly (e.g., a flexible circuit board) while also forming a seal between the proximal nose and the distal waveguide, the diaphragm may have a flexible electronic guide zone. Such a zone may involve forming a small slit in the diaphragm (e.g., a circumferential projection of the diaphragm, an outer O-ring of the diaphragm) that is sized and configured such that parts of the position sensor and / or electrical assembly (e.g., one or more electrical connections to the electronic assembly or flexible circuit board) can pass from the central region of the diaphragm to the space outside the proximal or distal chamber (e.g., other parts of the position sensor, such as a probe or Hall sensor, can be electrically connected to the electronic assembly while still maintaining the sealing of the diaphragm in the proximal and distal chambers). The flexible electronic guide zone of the diaphragm may include a flexible circuit board molded together with the diaphragm. Such zones may include thermal crimping for embedding such flexible circuit boards within the diaphragm. In embodiments, the ends of the flexible electronic equipment guide zones may comprise the formation of multiple sealing surfaces within the diaphragm (for example, between the groove of the proximal nose and the proximal side of the circumferential projection of the diaphragm (e.g., an O-ring), between the inside of the circumferential projection and the flexible circuit board, and / or between the distal side of the circumferential projection and the groove of the distal waveguide, as described herein).

[0100] In some embodiments, a structure for housing a position sensor, such as a Hall sensor, on or near the diaphragm may be molded into the diaphragm to ensure that the position sensor is securely held on or near the diaphragm while the diaphragm is translating proximal and distally, or during pulsed endovascular lithotripsy. For example, a projection or ridge with a pocket may be molded onto the diaphragm so that a portion of the position sensor (e.g., a Hall sensor) can be housed inside. Such a pocket may hold the position sensor (e.g., a Hall sensor) on its own, or it may be provided with an adhesive or a tape with very high adhesive strength. Adhesives of interest include cyanoacrylate, UV-curing adhesives, or multi-component adhesives. In other cases, the position sensor may be molded together and completely embedded within the diaphragm. In some embodiments, it is beneficial for the portion of the position sensor and / or the portion of the electronic connection and / or electronic assembly (e.g., a flexible circuit board) to have grooves or ridges configured to lock or grip the diaphragm and form an interlock. In other cases, the portion of the position sensor may be heat-crimped or ultrasonically welded to the diaphragm.

[0101] housing The distinct components of the handle assembly and the amplifier assembly may, in some cases, reside within a housing that includes a single housing. Such a housing surrounds the various components of the handle assembly and the amplifier assembly to protect the internal components. Such a housing may, if desired, substantially cover the proximal nose, distal waveguide, and diaphragm, as well as other components of the amplifier assembly. In embodiments, the housing is configured to cover and protect the components held therein, i.e., to protect the internal components from exposure to the environment and / or from wear and deterioration caused by the ingress of foreign matter. The form of the housing may vary, but in some cases, the housing of the handle assembly and the amplifier assembly comprises one or more snap-fit ​​shells configured to substantially surround the internal components, e.g., the proximal nose, distal waveguide, and diaphragm. In one embodiment, the housing comprises a shell, a snap-fit, and an exit port (i.e., a port for attaching the output to the amplifier assembly, i.e., configured to provide space for a catheter or other part to be operably connected, for example, to a catheter interface, to receive pulsed energy). The housing may be configured to securely connect the amplifier assembly and the handle assembly during use. Any connection system known in the art may be used that enables the handle assembly and the amplifier assembly to be connected in a safe and efficient manner during use. In embodiments, the amplifier assembly and the handle assembly are easily separated by the user releasing a snap-fit ​​lock.

[0102] If present, the housing may also cover the electrical assembly. However, the housing may be shaped such that the electrical connectors of the electrical assembly are exposed or can be exposed in order to form connections with other assemblies or systems, such as the handle assembly.

[0103] In embodiments, the housing may also be configured to hold the amplifier system in place in the handle assembly, for example, during use. In some cases, the housing includes one or more flexible arms for interface with the handle assembly. Such one or more flexible arms may be configured to hold the proximal interface of the proximal nose in a fixed position relative to the handle assembly. In embodiments, the flexible arms are double-sided "snap-fits" to provide a "quick-connect" retaining structure that "snaps" into a mating receptacle (e.g., of the handle assembly) when correctly oriented and positioned. These snap-fit ​​structures may be curved outward so as to compress during insertion (i.e., into the mating receptacle of the handle assembly) and return to their original position while inside the mating receptacle. Once the flexible arms (i.e., snap-fits) return to their original position, the retaining structures lock into their respective receptacles (i.e., of the handle assembly) to prevent longitudinal movement (i.e., the amplifier assembly being detached from the handle assembly). To release the amplifier assembly, the flexible arms (i.e., the snap-fit ​​arms) can be compressed inward, freeing the retaining structure from its respective receptacle. Once the snap-fit ​​lock is released, the amplifier assembly can be detached, for example, from the handle assembly.

[0104] In some embodiments, the housing may be configured to provide a portable unit. In such cases, the portable component, such as a portable amplifier assembly, is designed to be held and operated in one hand by an adult. If present in the embodiment, one or more flexible arms may be configured to provide tactile feedback for interface with the handle assembly.

[0105] One or more flexible arms may comprise portions of a snap-fit ​​groove structure in the amplifier assembly. In embodiments, the snap-fit ​​groove allows a flexible interlock retaining structure on the housing to be compressed during engagement and disengagement with the handle assembly. The depth of the snap-fit ​​groove (i.e., its length along the long axis of the amplifier assembly) ensures sufficient travel distance for this purpose.

[0106] In some cases, the housing includes one or more grooved portions or gripping points configured for gripping the amplifier assembly by hand. In particular, such grooved portions or gripping points may be configured to assist in handling the amplifier assembly while wearing gloves, as may be required in the operating environment.

[0107] The form factor of such housings may vary as desired, but in some cases, such housings have a diameter and / or length in the range of 25mm to 100mm, such as 40mm to 50mm, and a length in the range of 50mm to 150mm, such as 75mm to 100mm.

[0108] Further details regarding embodiments of amplifier assemblies or related components that may be incorporated into or used in conjunction with embodiments of the present invention are provided in U.S. Patent No. 11,464,949, pending PCT application PCT / US2020 / 055458, U.S. Patent Application No. 63274832, pending PCT application PCT / US2022 / 014785, U.S. Patent Application No. 63238381, pending PCT application PCT / US2022 / 040586, U.S. Patent Application No. 63346703, pending PCT application PCT / US23 / 23533, U.S. Patent Application No. 63346704, pending PCT application PCT / US23 / 22685, and U.S. Patent Application No. 63444414, the disclosures of which are incorporated herein by reference.

[0109] Various parts of the amplifier assembly of the present invention have been described in general above, and here the elements of the amplifier assembly will be further considered in the context of a particular embodiment. Specific Embodiments

[0110] An amplifier assembly according to one embodiment of the present invention is shown in Figure 1B. Figure 1B shows an isometric view of the amplifier assembly 100, with the relatively proximal region of the amplifier assembly 100 on the right side of the figure and the relatively distal region of the amplifier assembly 100 on the left side of the figure.

[0111] The amplifier assembly 100 includes a proximal nose 110 located in a relatively proximal region of the amplifier assembly 100. The proximal nose 110 includes a proximal interface 120. As described herein, the amplifier assembly in question interfaces with a handle assembly 101 (shown in Figure 1C) such that the proximal interface 120 of the proximal nose 110 contacts and operably connects with a corresponding interface of the handle assembly. A high-pressure connector 123 is located at the center of the proximal interface 120 and is configured to receive a high-pressure fluid (e.g., a pulse of high-pressure fluid) from a pressure source via the handle assembly operably connected to the proximal interface 120 of the amplifier assembly 100. The high-pressure connector 123 is configured to provide an interface for a high-pressure fluid (e.g., a pulse of high-pressure fluid), such as a high-pressure gas (e.g., compressed air or compressed CO2), to access the proximal chamber inside the amplifier assembly 100, facilitating the translation of the diaphragm present within the amplifier assembly so that the diaphragm exerts pressure in the distal chamber of the amplifier assembly 100. The high-pressure connector 123 seals the high-pressure fluid within the amplifier assembly 100, in part, by an O-ring present in the O-ring groove 125 of the high-pressure connector 123. In the amplifier assembly 100, the high-pressure connector 123 is a plastic-molded metal component of the proximal interface 120 of the proximal nose 110.

[0112] The proximal interface 120 of the proximal nose 110 may be aligned with the handle assembly 101, in part using alignment or keying elements 127, such as keyways, that are present on the proximal interface 120. The alignment or keying elements, i.e., keyed surfaces 127, include grooves located near the circumference of the proximal interface 120, such that corresponding alignment elements present on the handle assembly allow the amplifier assembly 100 and the handle assembly to be operably connected in a particular desired alignment, such as a rotational alignment. For example, the alignment element 127 may interface with corresponding elements of the handle assembly 101 so that the high-voltage connector 123 is properly aligned with a bore on the handle assembly (i.e., operably aligned or aligned so that a fluid connection is maintained), or so that the electrical connector 130 of the electrical assembly is properly aligned with a corresponding electrical connector on the handle assembly (i.e., so that an electrical connection is made), thereby maintaining fluid and electrical connections between the handle assembly 101 and the amplifier assembly 100.

[0113] The electrical connector 130 of the electrical assembly of the amplifier assembly 100 is located in the upper and outer region of the proximal interface 120 of the proximal nose 110. The electrical connector 130 of the electrical assembly comprises a flat plate made of a conductive material, such as a corrosion-resistant metal. The electrical connector 130 of the electrical assembly comprises a flat plate that is positioned to interface with the ball connector (also called a pin connector) of the handle assembly (i.e., a substantially round electrical connector whose position is spring-driven to physically contact the round end of the ball connector with the plate for electrical connection) when the handle assembly is operably connected to the amplifier assembly, and is of such shape, arranged in such manner, and otherwise configured in such manner. The pin connector is well known in the art and comprises a substantially round electrical connector whose position is spring-driven to physically contact the round end of the ball connector with the plate for electrical connection. Such plate-ball (i.e., plate-pin) connections provide electrical connections between components (for example, between the plate of the electrical connector 130 and the ball connector of the handle assembly) in an orientation perpendicular to the long axis of the amplifier assembly 100.

[0114] As described, embodiments of amplifier assemblies are configured to releasably engage with embodiments of handle assemblies according to the present invention so that the amplifier assembly is operably connected to a handle assembly. Amplifier assemblies, such as the amplifier assembly 100 in Figure 1B according to one embodiment of the present invention, are shown in Figure 1C and the handle assembly 101 according to one embodiment of the present invention, illustrating the general orientation of how the amplifier assembly 100 may be operably connected to the handle assembly 101, namely, that the proximal interface of the amplifier assembly 100 can be brought into contact with the distal interface of the handle assembly 101, and that these two assemblies releasably engage to form an operable connection between them.

[0115] The electrical connector 130 of the electrical assembly is arranged in a pattern in the outer region of the proximal interface 120 such that when the amplifier assembly 100 engages with the handle assembly, the corresponding electrical connector of the handle assembly (e.g., a ball connector) interfaces with the individual plate connectors of the electrical connector 130 of the electrical assembly shown in Figure 1B. The amplifier assembly 100 has nine individual electrical connectors, which is a rectangular plate with an extended, i.e., relatively elongated plate in the center. The central plate corresponds to the ground connection and has a shape and position such that the ground connection is the first electrical connection made when making an electrical connection between the electrical assembly 130 of the amplifier assembly 100 and the handle assembly, and similarly, the ground connection is the last connection to be released when disconnecting such an assembly. Configuring the electrical assembly 130 such that the ground connection is the first connection made and the last connection to be released is a safety feature of the amplifier assembly 100 and the corresponding handle assembly, intended to help ensure, for example, that any unexpected charges in the amplifier assembly 100 or the operably connected handle assembly are safely discharged.

[0116] The electrical connector 130 of the electrical assembly can electrically connect to outputs from sensors present on the amplifier assembly 100. For example, sensors that detect the position of diaphragms in the proximal and distal chambers (e.g., Hall effect-based sensors, i.e., Hall sensors) may be integrated into the amplifier assembly 100, and the output of such sensors may ultimately be output to an electrical connector on the electrical assembly (i.e., one or more of the plates of the electrical connector 130 in Figure 1B). Similarly, sensors that detect the pressure in the distal chamber of the amplifier assembly 100 may be integrated into the amplifier assembly 100, and the output of such sensors may ultimately be output to another electrical connector on the electrical assembly. Other types of sensors may be present in the amplifier assembly 100.

[0117] The electrical assembly to which the electrical connector 130 is electrically connected further comprises electronic circuits configured to receive electrical signals output from sensors or other electrical elements of the amplifier assembly 100, modulate such electrical signals as desired, and output them to one or more electrical connectors 130. In some cases, the electrical assembly comprises a memory optionally configured to record sensor readings over time. Such electrical circuits may reside on a circuit board, such as a flexible printed circuit board located within the amplifier assembly 100, such that such components are not visible when the amplifier assembly 100 is viewed from the outside. The electrical connector 130 may also be used to receive signals transmitted from the handle assembly, such as control signals for one or more sensors or power supplies for one or more sensors.

[0118] Generally, the electrical connector 130 may be configured to provide electrical connections to various components of the amplifier assembly 100, as desired. For example, the electrical connector of the electrical assembly 130 may be used to transmit data regarding the position, memory, and / or pressure of a diaphragm, and to supply power to a sensor, as desired.

[0119] The distal waveguide 160 is located in its relatively distal region within the amplifier assembly 100. The output of the distal waveguide 160 (i.e., such output is transmitted relatively distally within the amplifier assembly 100) is connected to a catheter assembly 165 which comprises or is ultimately connected to one or more catheters used to transmit the energy output by the distal waveguide 160, such as pressure pulses or static pressure. That is, the catheter assembly 165 receives the energy output by the distal waveguide 160 of the amplifier assembly, such as pressure pulses or static pressure, which is received and transmitted by the amplifier assembly 100 and ultimately transmitted. The catheter assembly 165 may comprise one or more catheters and housings, such as tubes, to surround such catheters. The catheter assembly 165 may further include one or more strain relief sections, such as a flexible tube or reinforced tube, or a flexible tube with a metal spring wound on the outside, to assist in the placement of the amplifier assembly 100 and related or interconnected components such as the handle assembly (for example, when the amplifier assembly is operably connected to the handle assembly) and the console in a surgical environment such as an operating room where the patient is located.

[0120] The housing 190 provides a durable cover for internal elements of the amplifier assembly 100, such as the proximal nose 110 and the distal waveguide 160, such that the proximal nose 110 and the distal waveguide 160 are substantially surrounded by the housing 190. The housing 190 is formed by one or more elements, such as a cover, which are combined to surround a portion of the amplifier assembly 100, as desired. The housing 190 is configured to protect the internal elements of the amplifier assembly from wear and deterioration due to use and to provide a connector interface used to operably connect the amplifier assembly 100 to the handle assembly. In the amplifier assembly 100, such an interface comprises a flexible arm 193. The flexible arm 193 includes a ratchet element for insertion into the receptacle of the handle assembly, which holds the amplifier assembly 100 in place relative to the handle assembly and maintains an operable connection between the amplifier assembly and the handle assembly during treatment. Such a ratchet element of the flexible arm 193 snaps into position when operably connected to the handle assembly, thereby providing tactile feedback, e.g., a “snap” or “click,” when the amplifier assembly 100 (particularly the proximal interface 120 of the proximal nose 110) is operably connected to the handle assembly. The flexible arm 193 and the corresponding receptacles on the handle assembly serve the additional purpose of aligning the two parts when operably interfaced the amplifier assembly 100 and the handle assembly, for example, so that the electrical connector 130 of the electrical assembly aligns with the corresponding connector on the handle assembly. The flexible arm 193 can be operated by hand, for example, by being pushed down by hand, to detach the amplifier assembly 100 from the handle assembly. The flexible arm 193 may be made of a hardened plastic having sufficient strength and hardness to hold the amplifier assembly 100 in position when interfaced with the handle assembly. Other mechanisms can be considered for reversibly mounting the amplifier assembly 100 to the handle assembly.

[0121] The exterior of the housing 190 is shaped to include a gripping portion 195 having grooves, treads, or other shapes or textures, facilitating the handholding and / or manipulation of the amplifier assembly 100 without it slipping or rotating in an undesirable or unexpected manner, even when held by a gloved hand.

[0122] Figure 2A shows an internal, or cross-sectional, view of an amplifier assembly 200 according to one embodiment of the present invention. The amplifier assembly 200 may be, for example, the amplifier assembly 100 shown in Figure 1B. In Figure 2A, elements having the same or similar reference numerals have the same or similar characteristics as the corresponding elements in Figures 1A to 1C unless otherwise specified.

[0123] In the amplifier assembly 200, the diaphragm 270 is held in place within the amplifier assembly 200 between the proximal nose 210 and the distal waveguide 260 by retaining pins 267. In this embodiment, the pins 267 are metal pins, but any material known in the art is assumed. The metal pins 267, i.e., retaining pins, present in the amplifier assembly are used to hold the diaphragm 270 in place, i.e., by compressing the distal waveguide 260 against the proximal nose 210. The metal pins 267 may be inserted into a hole in the proximal nose 210, for example, or molded to contact and abut the distal surface of the distal waveguide 260. Other techniques may also be used to hold the distal waveguide 260 against the proximal nose 210 with the diaphragm 270 in between.

[0124] In another embodiment shown in Figure 2B, the diaphragm 270 is held in place within the amplifier assembly 200 between the proximal nose 210 and the distal waveguide 260 using a clip 299. Figure 2B shows the amplifier assembly 200 without the housing 190. The clip 299 is configured to snap onto the proximal nose 210 and the distal waveguide 260 to firmly hold the diaphragm 270 in a sealed position. The clip 299 further comprises a tab 298 at its proximal end for further securing the diaphragm 270. The tab 298 may be bent radially inward at a hinge 297, or the tab 297 may rotate inward. In this embodiment, the clip 299 is a metal clip, but any material known in the art, such as metals and polymers, is conceivable.

[0125] The diaphragm 270 is held between the proximal nose 210 and the distal waveguide 260 such that the proximal chamber 212 is sealed on the relatively proximal side of the diaphragm 270 and the distal chamber 262 is sealed on the relatively distal side of the diaphragm 270. The diaphragm 270 is configured to translate back and forth (i.e., relatively proximal and relatively distal) within the proximal chamber 212 and the distal chamber 262. More specifically, the diaphragm 270 is configured to translate back and forth (i.e., relatively proximal and relatively distal) between the distal surface 211 (of the proximal nose 210) and the proximal surface 261 (of the distal waveguide 260). The diaphragm 270 is configured to do so without causing strain on the diaphragm 270. In other words, the diaphragm 270 is configured to do so without generating tension in the diaphragm 270, without stretching the material of the diaphragm 270, without resistance from the material of the diaphragm 270, or without applying stress to the material of the diaphragm 270.

[0126] In Figure 2A, the diaphragm 270 is shown in a neutral state, i.e., relaxed state, approximately midway between the distal surface 211 and the proximal surface 261. Such a state corresponds to the presence of relatively equal pressure within the proximal chamber 212 and the distal chamber 262.

[0127] In the amplifier assembly 200, the diaphragm 270 includes pleats 273 shaped to allow the diaphragm 270 to translate between the distal surface 211 of the proximal nose 210 and the proximal surface 262 of the distal waveguide 260. Depending on the distance the diaphragm 270 translates away from the neutral position shown in Figure 2A, the diaphragm 270 is biased to unfold the pleats 273, thereby taking on a new shape that allows the diaphragm 270 to occupy the new position without causing distortion to the diaphragm 270. For example, the pleats 273 of the diaphragm 270 are shaped such that when the diaphragm 270 is fully translated into the distal surface 211, such pleats unfold to be in a position to contact or surround the distal surface 211 substantially seamlessly. Similarly, the pleats 273 of the diaphragm 270 are shaped and positioned such that when the diaphragm 270 is fully translated into the proximal surface 261, such pleats unfold and contact or surround the proximal surface 261 substantially seamlessly. The diaphragm 270 includes pleats 273 that are shaped and positioned such that when the diaphragm 270 is fully translated into its proximal and distal positions, it can fit into recesses or curves in the distal surface 211 and recesses or curves in the proximal surface 261.

[0128] As described above, the proximal nose 210 includes a distal surface 211 located on the inner distal surface of the proximal nose 210. The volume between the distal surface 211 of the proximal nose 210 and the diaphragm 270 forms the proximal chamber 212. In the embodiment, the proximal chamber 212 receives energy, such as pressure pulses or static pressure, from a fluid, such as CO2, entering the amplifier assembly 200 via the high-pressure connector 223 of the proximal interface 220. Such energy, such as pressure pulses or static pressure, from a fluid, such as CO2, entering the amplifier assembly 200 via the high-pressure connector 223 is sealed within the high-pressure connector 223 and the proximal chamber 212 by an O-ring located in the O-ring groove 225 of the high-pressure connector 223. The distal surface 211 of the proximal nose 210 is shaped such that when the diaphragm 270 is fully translated to its proximal position, it will sit on the distal surface 211 of the proximal nose 210, that is, the pleats 273 or the diaphragm 270 will unfold or spread to follow the shape of the distal surface 211, and as a result the diaphragm 270 will translate without causing any distortion to the diaphragm 270.

[0129] As described above, the distal waveguide 260 includes a proximal surface 261 located on the internal proximal surface of the distal waveguide 260. The volume between the proximal surface 261 of the distal waveguide 260 and the diaphragm 270 forms the distal chamber 262. The proximal surface 261 of the distal waveguide 260 is shaped such that when the diaphragm 270 is fully translated to its distal position, it seats itself on the proximal surface 261 of the distal waveguide 260. That is, the pleats 273 of the diaphragm 270 unfold or spread out in accordance with the shape of the proximal surface 261, and as a result, the diaphragm 270 is translated without causing distortion to the diaphragm 270.

[0130] The distal chamber 262 receives energy, such as pressure pulses or static pressure, as the diaphragm 270 is translated as a result of energy applied to the proximal chamber 212, such as pressure pulses or static pressure. Such energy, such as pressure pulses or static pressure, is transmitted along the distal waveguide 260 and ultimately output to a catheter assembly 265, which is fluidly connected to the output of the distal waveguide 260, via a catheter interface 264, such as a threaded connector or a Luer lock mechanism such as a Luer lock or floating Luer lock, or optionally another operable connector. Such a catheter interface 264 is in fluid communication with the distal chamber 262 of the distal waveguide 260. In any case, such a catheter interface 264 receives high-pressure fluid, i.e., pulses of high pressure and / or static pressure, from the distal chamber 262. Such pressure may be transmitted via fluid in the distal chamber 262, such as saline solution.

[0131] Partially to seal the proximal chamber 212 and the distal chamber 262 (i.e., to fluidly seal such chambers), the diaphragm 270 is provided with substantially T-shaped projections 275 on its outer circumference. Such projections are shaped to seal the connection between the proximal nose 210 and the distal waveguide 260 so that the fluid cannot escape from between these elements even when relatively high pressures, including high-pressure pulses, are applied to the fluid present in either chamber, and / or when the diaphragm 270 is fully translated in the proximal or distal direction.

[0132] As described above, the proximal nose 210 includes a proximal interface 220 for interface with the handle assembly. The proximal interface 220 includes a high-pressure connector 223 for receiving energy, such as fluids, such as fluid pressure pulses or static fluid pressure, and such fluids may be gases, such as CO2 or air. Such a high-pressure connector 223 is in fluid communication with the proximal chamber 212. That is, the high-pressure connector 223 is configured to receive a high-pressure fluid, i.e., from the handle assembly, and to transmit such pressure to the proximal chamber 212. The high-pressure connector 223 may be made of metal and / or molded into the material of the proximal nose 210, for example, molded into the plastic of the proximal nose 210. The high-pressure connector 223 further includes an O-ring groove 225 configured to receive an O-ring. Also as described above, the proximal interface 220 includes a alignment element 227, i.e., a keying element such as a keyway, such as a groove or a set of grooves, configured to align the amplifier assembly 200 with the handle assembly.

[0133] The electrical connector 230 of the electrical assembly 235 is located relatively above the proximal nose 210. The electrical assembly 235 comprises a flexible printed circuit board electrically connected to the electrical connector 230 and the outputs of various sensors described herein.

[0134] The distal waveguide 260 is shaped to allow access to the distal region of the distal chamber 262, and as a result, the pressure sensor 269 can be positioned on the distal waveguide 260, enabling pressure readings of a fluid present in the distal chamber 262, such as saline solution. Any convenient pressure sensor 269 capable of measuring the pressure of a fluid and generating an electrical signal based on such readings may be used. The pressure sensor 269 is integrated with the distal waveguide 260 in any convenient way, for example, via a threaded interface. The pressure sensor 269 is used to sense pressure, including pressure changes, within the distal chamber 262, i.e., caused by pressure pulses, and therefore transmitted or delivered to the distal balloon, which is ultimately operably connected to the amplifier assembly 200 via the catheter interface 264 and catheter assembly 265. That is, the pressure readings obtained by the pressure sensor 269 reflect the pressure applied by the amplifier assembly 200 to, for example, the distal balloon or other tissue engagement element, and therefore, where applicable, to a lesion proximal to such balloon or other tissue engagement element. The output of the pressure sensor 269 is electrically connected to the electrical assembly 235 so that the readings of the pressure sensor 269 can be processed, stored, and / or transmitted by the electrical assembly 235 (for example, via the electrical connector 230).

[0135] The amplifier assembly 200 further comprises one or more sensors for sensing the position of the diaphragm 270, i.e., how far the diaphragm 270 has translated between the distal surface 211 and the proximal surface 261. Many commonly available sensors are assumed. In the embodiment shown in Figure 2A, the amplifier 200 comprises a Hall sensor for such a position sensor, i.e., for sensing the position of the diaphragm 270. Such a Hall sensor comprises a first magnet 276 integrated with the proximal nose 210 and a second magnet 266 integrated with the distal waveguide 260. Such magnets remain a certain distance apart from each other and, where applicable, are arranged to remain in fixed positions on the proximal nose 210 and the distal waveguide 260. Such magnets may be oriented in any convenient orientation with respect to magnetic polarity. The Hall sensor further comprises an electrical probe 275 located in the central region of the diaphragm 270. The electrical probe 275 is electrically connected to the electronics assembly 235 via a "pigtail" connector, i.e., a connector with sufficient slack in the length of the connector to follow the movement of the diaphragm 270 back and forth toward the proximal surface 261 and distal surface 211. Such an electrical probe may be fixed to the diaphragm 270 using any convenient means such as bonding techniques or glue, such as epoxy or adhesive, as long as the electrical probe 270 moves together with the diaphragm 270 as a result of pressure, such as pressure pulses or static pressure, being applied to the amplifier assembly 200, and to the same extent as it moves.

[0136] The position of the diaphragm 270 corresponds to the volume (or change in volume) of the distal chamber 262, which corresponds to the volume change of the balloon or other tissue engagement element operably connected to the amplifier assembly 200 via the catheter interface 264 and catheter assembly 265. Such volume changes of the balloon or other tissue engagement element provide information related to the treatment of a lesion, for example, information that may indicate a change in balloon volume when the same or different pressure is applied to the balloon, i.e., information related to vascular compliance. The proximal nose 210 comprises a first receptacle for holding a first magnet in a fixed position. The distal waveguide 260 comprises a second receptacle for holding a second magnet in a fixed position. Such a receptacle may incorporate any convenient technique or mechanism for holding the magnet in a fixed position, such as a joint, adhesive, glue, or mechanical configuration. For example, the first and second receptacles are provided with crush ribs, which mean protrusions (i.e., ribs) around the outer circumference of the receptacle in which the magnet is placed between them, thereby compressing (i.e., crushing) such ribs so that the magnet is held in place by the tension between such ribs.

[0137] In some embodiments, the position sensor may be configured such that a magnet may be located in the central region of the diaphragm 270, and one or more electrical probes may be positioned at fixed locations on the distal waveguide 260 and / or the proximal nose 210. Such a configuration may result in ease of manufacture or a longer service life for the amplifier assembly 200, as the magnet located on the diaphragm 270 does not require an electrical connection to the electronics assembly 235.

[0138] The housing 290 is located around the outside of the proximal nose 210, the distal waveguide 260, and the diaphragm 270, and such elements are substantially surrounded by the housing 290. The housing 290 is shaped to expose the proximal interface 220 for interface with the handle assembly and the output of the catheter interface 264, so that the output of the amplifier assembly 200 is transmitted to the catheter assembly 265.

[0139] Figures 3A and 3B show the proximal nose of an amplifier assembly according to one embodiment of the present invention. In Figures 3A and 3B, elements having the same or similar reference numerals have the same or similar characteristics as the corresponding elements in Figures 1 and 2, unless otherwise specified.

[0140] Figure 3A shows an external view of the proximal nose 310 of an amplifier assembly, such as the amplifier assembly 100 shown in Figure 1B or the amplifier assembly 200 shown in Figure 2A. The most proximal side of the proximal nose 310 is shown on the right side of the figure, and this side of the proximal nose has a chamfered outer edge. This side of the proximal nose 310 is chamfered to facilitate alignment and to form an operable connection with the handle assembly. Hole 368 is included for inserting a retaining pin, such as pin 267 shown in Figure 2A, for holding the proximal nose 310 together with the distal waveguide 260 (for example, holding the proximal nose 210 relative to the distal waveguide 260 and sealing the diaphragm 270 between the proximal nose 210 and the distal waveguide 260, for example, compressing the diaphragm 270 between the proximal nose 210 and the distal waveguide 2600).

[0141] The proximal side or proximal region (shown on the right side of the figure) of the proximal nose 310 is configured to substantially cover or surround the proximal interface 320, including the high-voltage connector 323 (i.e., the high-voltage connector 323 does not protrude or extend proximal beyond the proximal nose 310), thereby partially protecting these elements from accidental damage or wear and deterioration.

[0142] Figure 3B shows a cross-sectional view, or cutout, of the proximal nose 310. The distal surface 311 of the proximal nose 310 defines the proximal chamber 312 (which is sealed when a diaphragm is present). The shape, i.e., curvature, of the distal surface 311 is selected to correspond to the pleats or folds of the diaphragm, and the diaphragm interfaces with the distal surface 311 at its most proximal position. The proximal interface 320 includes a high-voltage connector 323 fluidly connected to the proximal chamber 312 and has an O-ring groove 325 for seating an O-ring that seals the inside of the high-voltage connector 323 when the handle assembly is operably connected to the proximal nose 310 at the proximal interface 320. The high-voltage connector 323 is fluidly connected to the proximal chamber 312, and as a result, energy received through the high-voltage connector 323, such as pressure pulses, pneumatic pulses, or static pressure such as static pneumatic pressure, is transmitted to the proximal chamber 312 and to the diaphragm located in the distal region of the proximal chamber 312 that seals the proximal chamber 312. The high-voltage connector 323 is made of metal integrated into the material (e.g., plastic) of the proximal nose 310.

[0143] The proximal nose 310 includes a first magnet compartment or receptacle 378 for receiving a first magnet (not shown) which includes a position sensor, such as part of a Hall sensor, for sensing the position of the diaphragm as it translates between the distal surface 311 of the proximal chamber 312 and the proximal surface of the distal chamber. The first magnet compartment or receptacle 378 includes crush ribs 377 (i.e., portions of the first magnet compartment 378 extending from its surface) for holding the magnet in a fixed position within the first magnet compartment or receptacle 378 by compressing or crushing the magnet between them.

[0144] Figures 4A to 4B show the distal waveguide of an amplifier assembly according to one embodiment of the present invention. In Figures 4A to 4B, elements having the same or similar reference numerals have the same or similar characteristics as the corresponding elements in Figures 1 to 3 unless otherwise specified.

[0145] Figure 4A shows an external view of the distal waveguide 460 of an amplifier assembly, such as the amplifier assembly 100 shown in Figure 1B or the amplifier assembly 200 shown in Figure 2A. The distal waveguide 460 is oriented such that the proximal side is shown on the right side of the figure and the distal side is shown on the left side. The proximal side of the distal waveguide 460 has a shape that interfaces with the diaphragm.

[0146] The proximal outer circumference is provided with a rounded chamfer or stepped portion 463 configured to interface with a projection on the outer circumference of the diaphragm (e.g., element 275 of the diaphragm 270 shown in Figure 2A) so that the diaphragm can be sealed between the proximal nose and the distal waveguide 460, thereby sealing the distal chamber 462.

[0147] The distal waveguide 460 is shaped to include a pressure sensor interface 471 that accepts a pressure sensor (e.g., pressure sensor 269 in Figure 2A). Such an interface 471 allows the pressure sensor to be integrated into the distal waveguide 460 in any convenient manner, for example, via a threaded interface. The pressure sensor interface 471 is fluidly connected to the output of the distal chamber 462 so that a pressure sensor located within the interface 471 can sense the pressure in the distal chamber 462, i.e., pressure changes caused by pressure pulses. Thus, such pressure readings correspond to the pressure transmitted through the catheter interface 464 to the distal balloon, which is ultimately operably connected to the distal waveguide 460. The pressure sensor interface 471 is positioned such that a pressure sensor present in such an interface can be electrically connected to the electrical assembly of the amplifier assembly.

[0148] The catheter interface 464 includes any convenient mechanism for attaching a catheter to receive output energy transmitted from the distal chamber 462 to the catheter interface 464, such as a fluid, such as saline solution, for example, a pressure pulse or static pressure. Such a mechanism may include, for example, a Luer lock or a floating Luer lock. Figure 4A shows the catheter interface 464 with threads for a threaded interface to an output catheter assembly.

[0149] The external shape of the distal waveguide 460 includes a rounded surface 472 shaped to receive a retaining pin, such as a steel pin (such as the pin 267 shown in Figure 2A), extending across the width of the proximal nose (such as the proximal nose 210 shown in Figure 2A), through a hole (for example, hole 368 shown in Figures 3A to 3B), thereby holding the distal waveguide 460 relative to the proximal nose and sealing the diaphragm between them.

[0150] Figure 4B shows a cross-sectional view of the distal waveguide 460. The proximal surface 461 of the distal waveguide 460 defines the distal chamber 462 together with the diaphragm. The proximal surface 461 is shaped such that the folding or pleating of the diaphragm can unfold to conform to the surface of the proximal surface 461 without causing distortion to such diaphragm (i.e., at the most distal position of such diaphragm).

[0151] The second magnet compartment or receptacle 478 is located in the distal region of the distal chamber 461 and is shaped to receive a magnet (not shown) which includes a position sensor, such as part of a Hall sensor, for sensing the diaphragm position as it translates between the proximal surface 461 of the distal chamber 462 and the distal surface of the proximal chamber. The second magnet compartment or receptacle 478 includes crush ribs 477 (i.e., projections of the second magnet compartment 478 extending from its surface) for holding the magnet in a fixed position within the second magnet compartment 478 by compressing or crushing the magnet between them.

[0152] Figures 5A to 5C are schematic diagrams of a diaphragm of an amplifier assembly according to one embodiment of the present invention. In Figures 5A to 5C, elements having the same or similar reference numerals have the same or similar characteristics as the corresponding elements in Figures 1 to 4 unless otherwise specified.

[0153] Figure 5A shows the diaphragm 570 with its distal surface. The distal surface refers to the side of the diaphragm 570 that faces the distal region of the amplifier assembly when the diaphragm 570 is installed therein. Such a distal surface faces the proximal surface of the distal chamber (e.g., the proximal surface 461 of the distal chamber 462 shown in Figure 4B) and can contact it. Figure 5B shows the diaphragm 570 with a cross-sectional view. Figure 5C shows the diaphragm 570 with its proximal surface. The proximal surface refers to the side of the diaphragm 570 that faces the proximal region of the amplifier assembly when the diaphragm 570 is installed therein. Such a proximal surface faces the distal surface of the proximal nose (e.g., the distal surface 311 of the proximal chamber 462 shown in Figure 3B) and can contact it.

[0154] The diaphragm 570 includes a fold 573. The fold 573 is such that, when installed in the amplifier assembly between the proximal nose and the distal waveguide, the diaphragm 570 can be translated between the distal surface of the proximal nose and the proximal surface of the distal waveguide by unfolding the fold 573, thereby causing no strain or substantial strain on the diaphragm 570; that is, it does not cause strain on the diaphragm material, nor does it create tension in the diaphragm material, nor does it stretch the diaphragm material, nor does it exert resistance from the diaphragm material, nor does it apply stress to the diaphragm material. In other words, the diaphragm 570 unfolds itself, takes on a new shape, and ultimately fits to the distal surface of the proximal nose at its most proximal position and to the proximal surface of the distal waveguide at its most distal position. The diaphragm 570 includes a circumferential projection 575 in the region of the outer circumference of the diaphragm 570. The projection 575 is present on the diaphragm 570 to allow the diaphragm 570 to maintain its sealing to the proximal and distal chambers even while translating between the distal surface of the proximal nose and the proximal surface of the distal waveguide. The projection 575 is shaped to interface with, for example, the stepped portion or chamfer 463 of the distal waveguide shown in Figures 4A and 4B.

[0155] Figures 6A to 6C show schematic diagrams of an amplifier assembly housing according to one embodiment of the present invention. In Figures 6A to 6C, elements having the same or similar reference numerals have the same or similar characteristics as the corresponding elements in Figures 1 to 5, unless otherwise specified.

[0156] Figure 6A shows the housing 690 from a bottom view, with the relatively proximal side of the housing 690 at the top of the figure and the relatively distal side of the housing 690 at the bottom of the figure. Figure 6B shows a cross-sectional view of the housing 690, showing the shape of the internal cavity 691 of the housing 690. The internal cavity 691 is shaped so that the housing 690 can substantially enclose the distal waveguide, diaphragm, and proximal nose, as well as other components such as the electrical assembly. Figure 6C shows an isometric view of the housing 690.

[0157] The housing 690 provides a durable cover for the internal elements of the amplifier assembly contained therein. The housing 690 is shaped to include a flexible arm 693 for operably connecting the amplifier assembly housed within the housing 690 to the handle assembly. The exterior of the housing 690 is shaped to include a gripping section 695 having grooves or treads or other shapes or tactile features, facilitating the hand-holding and / or manipulation of the amplifier assembly contained within the housing 690 without slipping or rotating in an undesirable or unexpected manner.

[0158] One embodiment of the amplifier assembly may be assembled by the following steps 1 to 12 shown in Figure 7A, and these assembly instructions illustrate the interconnections between the elements of such an embodiment. Another amplifier assembly may be assembled by the following steps 1 to 13 shown in Figure 7B, and these assembly instructions illustrate the interconnections between the elements of such an embodiment.

[0159] Handle assembly As outlined above, a handle assembly is provided for controllably transmitting energy. In an embodiment, the handle assembly controls the transmission of a first pulse of energy delivered to an amplifier assembly. As shown in Figures 8A to 8F, the portion of the handle assembly 800 comprises a coupler assembly 850 operably connected to an energy source, a manifold 830 operably connected to the energy source via the coupler assembly 850 and configured to controllably transmit energy to a distal interface 810, and a distal interface 810 operably connected to the output of the manifold 830 and configured to transmit energy received from the manifold 830. In an embodiment, the handle assembly is operably connected to an amplifier assembly, such as one described herein, and configured to transmit energy from the energy source to the amplifier assembly.

[0160] Embodiments of a handle assembly are configured to operably interface with an amplifier assembly, for example, an embodiment of an amplifier assembly described herein. In embodiments, the handle assembly 800 is configured to detachably engage with the amplifier assembly 200 such that the two assemblies form an operable connection. When engaged and operating, the handle assembly delivers a first energy to the amplifier assembly. Such an operable connection may be configured to facilitate, for example, the transfer of energy from the handle assembly to the amplifier assembly. Such an operable connection may also be configured to facilitate certain electrical connections between the handle assembly 800 and the amplifier assembly 200, such as electrically connecting power connections, data connections, control connections, or common ground connections. In embodiments, the handle assembly 800 may have a keying element 815 or a specific shape, such as an asymmetrical shape, that allows the handle assembly and the amplifier assembly to engage releasably with each other only in a single designated orientation, i.e., an orientation in which the high-voltage connector 223 of the amplifier assembly 200 aligns with the bore 820 of the handle assembly 800, so that energy can be safely transferred from the handle assembly 800 to the amplifier assembly 200. In particular cases, such a keying element 815 or a specific shape, such as an asymmetrical shape, may further ensure interconnection between a particular electrical connector on the handle assembly and a particular electrical connector on the amplifier, as described herein.

[0161] In some embodiments, the handle assembly includes a distal interface configured to operably interface with the proximal nose of the amplifier assembly. In some cases, the alignment structure of the distal interface is configured to interface with a corresponding alignment structure of the proximal nose of the amplifier assembly. For example, the alignment structure of the distal interface may include a keyed surface, and the proximal nose of the amplifier assembly includes a corresponding keyed surface.

[0162] The handle assembly may be configured to be reusable or disposable, as desired. If the handle assembly (or part thereof) is reusable and may come into contact with the patient area, such assembly may be configured to be covered with a disposable sterile sleeve or bag so that the handle assembly can be used without contaminating the sterile field of the operating room.

[0163] Distal interface Embodiments of a handle assembly are configured to operably connect to an amplifier assembly, such as an amplifier assembly, as described herein. Embodiments of the handle assembly and amplifier assembly are configured so that these two assemblies can be aligned and connected by hand (as may be required in the operating environment), i.e., by hand or with a gloved hand. In embodiments, the distal interface of the handle assembly comprises one or more alignment structures configured to enable such alignment and operable connection with the amplifier assembly. In some cases, the alignment structure comprises a keyed projection configured to align the handle assembly with an external component such as the amplifier assembly, such as a keyed face or keyway of the amplifier assembly.

[0164] Embodiments of the distal interface are configured to interface operably with the proximal nose of the amplifier assembly. If present, the alignment structure of the distal interface may be configured to interface with the corresponding alignment structure of the proximal nose of the amplifier assembly. In embodiments, an alignment structure of the handle assembly and the corresponding alignment structure of the amplifier assembly may be used to align the electrical connector of the electrical assembly of the handle assembly with the electrical connector of the electrical assembly of the amplifier assembly.

[0165] In one embodiment, the distal interface of the handle assembly (sometimes called the receptacle of the handle assembly) holds and secures the amplifier assembly during use, preventing misuse of the assembly. The distal interface may be configured to mate with the proximal interface of the proximal nose of the amplifier assembly using a keyway that controls the rotational, axial, and radial position of the amplifier assembly relative to the distal interface of the handle assembly, as described herein. In some cases, the distal interface of the handle assembly has a substantially circular keyway shape with a grooved retaining element. However, other configurations may be used to control the position and orientation of the handle assembly relative to the amplifier assembly.

[0166] In some embodiments, a key located on the distal interface of the handle assembly is configured to slide into a corresponding keyway in the proximal interface of the amplifier assembly. In some cases, the distal interface of the handle assembly is machined from a metal such as steel, stainless steel, aluminum, brass, or other metals, as desired. If present, the key on the distal interface may be substantially linear in shape with uniform (non-draft) walls or sides. Embodiments of the corresponding proximal interface of the amplifier assembly may be injection molded, and this process may be configured to produce walls at a certain draft angle. Such a draft angle may be used to guide the key of the distal interface of the handle assembly into the positioning keyway of the proximal interface of the amplifier assembly, thereby ensuring alignment of the amplifier assembly when inserted into the distal interface of the handle assembly.

[0167] However, in other embodiments, different keying mechanisms may be utilized on the handle assembly and the corresponding amplifier assembly, such as having an additional keyway on the distal interface of the handle assembly and a key on the proximal interface of the amplifier assembly. In yet another embodiment, the distal interface may have an alignment structure within the keyway that accepts a corresponding structure on the key of the amplifier assembly.

[0168] In some embodiments, the distal interface of the handle assembly may be configured to facilitate interfacing with the amplifier assembly. In one embodiment, structural openings (e.g., two, three, four, five or more openings) of the distal interface may, for convenience, be configured to receive the mating and locking arms or snaps or other elements of the keyed interface of the amplifier assembly. Such openings may be circular or oval through holes or blind holes. Such openings may have grooves for compressing the snaps or snap mating or flexible arms of the amplifier assembly while inserting the amplifier assembly into the receptacle. The edges of such openings may hold the snaps or snap mating or flexible arms while operating the handle assembly and amplifier assembly, for example, during the transmission of pulsed energy. In some embodiments, the orientation of the handle assembly and the operable connection to the amplifier assembly may be maintained by one or more of the following: screws, mechanical, magnetic, or electromechanical latches, push connections, etc., and these elements may be located on the distal interface of the handle assembly.

[0169] As outlined above, in the embodiments, the distal interface of the handle assembly is configured to transmit energy received from the manifold. In the embodiments, the distal interface is configured to transmit such energy from the handle assembly to an amplifier assembly operably connected thereto. In some embodiments, the handle assembly includes an outlet port for transmitting energy (e.g., high-pressure gas) from the handle assembly to the amplifier assembly. In some cases, the distal interface of the handle assembly includes a bore configured to interface with the amplifier assembly, for example, to receive and interface with the high-pressure connector of the amplifier assembly (i.e., the connector nose of the high-pressure connector). Such a bore may include an outlet port of the manifold (e.g., an oscillator of the manifold, e.g., an output port of a solenoid valve) and may be of an appropriate size to form a seal with, for example, the connector nose of the high-pressure connector, e.g., an O-ring present on the connector nose of the high-pressure connector. In some embodiments, the distal interface and its alignment structure (e.g., alignment key) are used to align the amplifier assembly so that a desired alignment is achieved when the connector nose of the high-pressure connector enters the bore, in order to prevent misalignment between such a bore of the distal interface of the handle assembly and the connector nose of the high-pressure connector of the proximal interface of the amplifier assembly, which could in part result in, for example, eccentricity of the O-ring and / or leakage of high-pressure fluid (e.g., gas leakage) during treatment. In other embodiments, the bore is configured solely to form a seal with the connector nose of the high-pressure connector of the amplifier assembly and is not configured to position the proximal connector within the receptacle.

[0170] Coupler Assembly As outlined above, the handle assembly of the present invention comprises a coupler assembly operably connected to an energy source. That is, the coupler assembly is configured to receive energy from the energy source and transmit such energy in the handle assembly to a manifold. In embodiments, the coupler assembly is operably connected to the manifold of the handle assembly. For example, the manifold may be operably connected to the energy source via an input coupler of the coupler assembly. In some embodiments, the coupler assembly comprises an input coupler and a discharge coupler, the input coupler being operably connected to the energy source and the discharge coupler being configured to discharge energy from the energy source. In one embodiment, the coupler assembly comprises tubes, such as an input tube and a discharge tube. If present, the input tube may be operably connected to the energy source and the discharge tube may be configured to discharge energy from the energy source.

[0171] In embodiments, the handle assembly comprises a coupler assembly having an inlet port. In some cases, the coupler assembly (or its inlet port) may receive energy (e.g., high-pressure gas) from an energy source via a tube or hose, possibly having a high-pressure fitting, as is known in the art. The coupler assembly (or its inlet port) may be connected to one or more of a pressure sensor and a solenoid. To simplify the machining process relating to embodiments of the manufacture of the handle assembly and, for example, to reduce the need for plug fittings, a single bore can be formed between the pressure sensor, if present, the coupler assembly (or its inlet port), and the manifold oscillator (e.g., a solenoid) (in a region called the pressure sensor support zone). Such an inlet port may be equipped with a filter, such as a particle filter, to minimize the possibility of particles entering the manifold or its oscillator or fluid path (i.e., gas path).

[0172] In some cases, the handle assembly is configured such that the coupler assembly (or its inlet port) is directly aligned (e.g., substantially linearly aligned) with the outlet port of the handle assembly (e.g., the distal interface of the handle assembly, and / or the bore of the handle assembly, if present) to minimize the number of sharp turns that the high-pressure gas must make, thereby reducing the energy stored in the fluid (e.g., gas).

[0173] In one embodiment, the coupler assembly comprises a relatively long, flexible tube configured to interface with an energy source, for example, to transport a high-pressure fluid (e.g., a high-pressure gas) to the handle assembly, and / or to transport discharges from the handle assembly, and / or to transport electrical signals and / or communications to and from the handle assembly, and / or to transmit power to the handle assembly. The coupler assembly may be configured to have protective seals around the outside of parts of the coupler assembly, for example, to protect the coupler assembly from external wear and degradation in the operating environment.

[0174] manifold The handle assembly of the present invention further comprises a manifold. In embodiments, the manifold is operably connected to an energy source via a coupler assembly and configured to controllably transmit energy to the distal interface of the handle assembly. In embodiments, the manifold is configured to receive a high-pressure fluid, such as a high-pressure gas, and to controllably deliver such a high-pressure fluid to the distal interface of the handle assembly.

[0175] In some embodiments, the manifold includes an oscillator operably connected to an energy source. If present, the oscillator may be configured to transmit energy through the manifold in a first position and discharge energy in a second position. That is, the oscillator may be configured to send pulses of energy to the distal interface of the handle assembly.

[0176] In certain cases, a manifold may receive energy from one or more energy sources (for example, one or more console units each having one or more energy sources) and distribute that energy to one or more oscillators within the manifold. In some cases, there is a one-to-one correspondence between the energy sources and oscillators within the manifold. In other cases, a single energy source may supply energy to one or more oscillators. In yet another case, one or more energy sources may supply energy to a single oscillator, resulting in, for example, the energy of one or more energy sources being combined in a single oscillator.

[0177] In some embodiments, the energy transmitted to the oscillator comprises a fluid that is conditioned or unconditioned under pressure. The oscillator may be operated to output a pulsed pressure output and / or a static pressure output. In certain embodiments where the energy transmitted by the energy source is a fluid that is conditioned or unconditioned under pressure, the oscillator may comprise a solenoid valve. Such a solenoid valve may comprise, for example, a 3-port, 2-position normally closed solenoid valve. In such a case, the solenoid valve is configured to accept a conditioned or unconditioned 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 conditioned or unconditioned fluid at high pressure (i.e., an input port), a port operably connected ultimately to an amplifier assembly (i.e., via a distal interface), and a discharge port (i.e., a second output port). When the solenoid valve is turned on (i.e., in "on" mode), the valve may be configured to allow delivery of high-pressure regulated or unregulated fluid downstream of the handle assembly, such as delivery to an amplifier assembly operably connected to the handle assembly. When the valve is turned off (i.e., in "off" mode), the valve may be further configured to change, i.e., reverse, the port to which the solenoid is connected, so that the distal side of the valve is discharged (e.g., to the atmosphere or a vacuum). That is, in "off" mode, the first output port may be connected to the second output port to discharge the high-pressure fluid present on the distal side of the solenoid valve.

[0178] In certain embodiments, the oscillator frequency and / or duty cycle may be adjusted to produce a desired output, e.g., a suitable output for treatment, and a suitable output for an amplifier assembly operably connected thereto, e.g., a tissue engagement element, e.g., a distal balloon. In various embodiments, one or more oscillators in the manifold may be configured to oscillate at one or more frequencies and / or duty cycles. In a particular example, for example, an oscillator configured to perform pulsed endovascular lithotripsy on cardiovascular tissue may be configured to oscillate at frequencies of 0 to 50 Hz, such as 1 to 10 Hz or 10 to 20 Hz or 21 to 30 Hz or 31 to 40 Hz or 41 to 50 Hz, and at duty cycles of 10% to 90%, such as 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 pressure pulses using fluid pressure for therapies involving the perfusion of cardiovascular tissue, the oscillator may be oscillated with frequencies from 0.25 Hz to 5 Hz, such as 1 Hz or 2 Hz or 3 Hz or 4 Hz or 5 Hz, and duty cycles from 10 to 90%, such as 10% or 20% or 30% or 40% or 50% or 60% or 70% or 80% or 90%. In examples where the oscillator is configured to deliver pulsed energy with a light source or high voltage source, the oscillator may be oscillated with frequencies from 0.1 Hz to 1 GHz, such as 1 Hz or 2 Hz or 3 Hz or 4 Hz or 5 Hz or higher, and duty cycles from 0.0001% to 90%, such as 0.001% or 0.01% or 0.1% or 1% or 10% or 20% or 30% or 40% or 50% or 60% or 70% or 80% or 90%.

[0179] In certain embodiments, the output from the manifold oscillator, or in embodiments having two or more oscillators, the outputs from various oscillators, can be transmitted to one or more locations. In other embodiments with two or more oscillators, the oscillators can be synchronized with each other so that the pulsed energy transmitted from each oscillator is synchronized as desired, for example, with respect to magnitude, frequency, phase, duty cycle, etc. In other embodiments, the oscillators can be synchronized with external factors or systems or sensors, such as the results of an electrocardiogram (ECG), or can be adjusted based on volumetric or pressure measurements, such as volumetric or pressure measurements detected by a sensor located on a distal balloon operably connected to a tissue engagement element, for example, an amplifier assembly, or other parts of the system in which such an assembly is part.

[0180] As outlined above, if present, the oscillator may be a solenoid, and such a solenoid valve may be mounted to other parts of the handle assembly in any convenient configuration. In some cases, the solenoid (sometimes called a solenoid valve) may be a normally off solenoid (i.e., a solenoid configured to open the outlet port for exhaust when in the "off" position and pressurize the outlet port, e.g., the bore of the distal interface, when in the "on" or "open" position). In some cases, the solenoid is configured to use the linear motion of a plunger in relation to the transition between the "on" and "off" positions. In some cases, such linear motion is achieved by the action of a spring and an electromagnetic coil. In other embodiments, the lateral or rotational movement of the plunger produces the opening and closing of the solenoid (i.e., the opening and closing of the solenoid valve).

[0181] In embodiments, for example, a portion of the handle assembly including a manifold may be shaped to fit and secure within a surrounding enclosure, i.e., housing, as described below. For example, embodiments of a portion of the handle assembly including a manifold may be machined or cast from a solid metal block (e.g., stainless steel, aluminum, brass, or other metals, as desired) using a process such as lost-wax casting with a material such as brass (or other material as desired), or injection molded from a thermoplastic material such as nylon-12, PEEK, or ABS, which may be filled with glass or fiber. Electrical Assembly

[0182] Embodiments of a handle assembly further comprise an electrical assembly (also called an electronics assembly). The electrical assembly may be operably connected to any other part of the handle assembly, e.g., a manifold, and / or may be configured to be operably connected to an external device. The electrical assembly may be configured to perform a variety of functions as desired, including, for example, supplying power to various sensors in or outside the handle assembly, controlling such sensors, receiving data from such sensors, recording and / or transmitting such data to another location, e.g., wirelessly, controlling various parts of the handle assembly or parts outside the handle assembly, and / or storing information about the handle assembly or an amplifier assembly to which it is connected or other parts of the system to which the handle assembly is connected.

[0183] In some cases, the electrical assembly includes a controller programmed to perform, for example, self-check routines and / or self-diagnostic routines to verify the safety of the amplifier assembly. In one embodiment, the electrical assembly is a flexible printed circuit board and is configured to perform several functions, for example, forming electrical connections to the amplifier assembly, and / or storing catheter, balloon, and / or other treatment-specific information in memory, or reading such information from there.

[0184] In some embodiments, the electrical assembly is configured to control an oscillator. When configured in this way, the electrical assembly may be configured to move the oscillator from a first position to a second position, for example, from an "off" position to an "on" position. In some cases, the electrical assembly is configured to interface with external components, as desired, such as an amplifier assembly or one or more energy sources or a user console or other external components. In some cases, the electrical assembly is electrically connected to a plurality of pin connectors. For example, the handle assembly may have a pin connector configured to interface with a plate connector of an amplifier assembly.

[0185] In certain embodiments, the handle assembly includes an electronics bay configured to house an electronics assembly (or a part thereof, e.g., a printed circuit board). Such an electronics bay may be configured such that electrical contacts (e.g., pins, sliding contacts, rotary contacts, flexible contacts, etc., configured for electrical contact, the elements of which may reside on the printed circuit board) are positioned and / or oriented and / or at a certain height relative to an external component to which such contacts connect, e.g., an amplifier assembly. In embodiments, a seal can be formed between the part of the electronics assembly (e.g., the printed circuit board) and the electronics bay. Such a seal may be configured to partially or completely limit the amount of fluid that can enter the handle assembly.

[0186] In one embodiment, the electrical assembly comprises a plurality of electrical connectors, comparators, logic gates, and power management zones, which may be at least partially located on, for example, a printed circuit board. If located on a printed circuit board, the connectors on the printed circuit board may be oriented within the handle assembly so that they are positioned at a desired location in the handle assembly or its electronics bay, for example, to make an operational connection with an amplifier assembly. In some cases, the electronics assembly or its printed circuit board includes one or more protective features configured to protect connectors interface with the amplifier assembly that slide in and out of the distal interface of the handle assembly (other receptacles of the handle assembly, if applicable). In embodiments, the electrical assembly may be configured to perform several specific functions, including, for example, (1) detecting and / or disconnecting from the amplifier assembly, (2) supplying power or energy to an oscillator such as an LED or solenoid, and / or the amplifier assembly, (3) comparing sensor readings, e.g., comparing a handle pressure sensor reading with the maximum pressure assigned to the amplifier assembly, (4) detecting a position sensor (e.g., a Hall sensor) limit switch (i.e., if such one may be present in the amplifier assembly), and / or (5) detecting a safety limit and shutting off the power supply.

[0187] As described herein, embodiments of a handle assembly include a plurality of electrical connectors. Such connectors may be configured to interface with a handle assembly, communicate any desired data or control signals, be used to transmit power, or, in each case, be used to connect a common ground between such assemblies. In some cases, the plurality of connectors present on a handle assembly are pin connectors (also called ball connectors). A pin connector means a cylinder made of any convenient conductive material, such as metal, operably connected to a spring that biases the cylinder longitudinally toward a complementary connector on an amplifier assembly, for example. The spring or other biasing element is configured to ensure that the electrical connector maintains a consistent physical, and therefore electrical, connection. In embodiments, the complementary connector on an amplifier assembly includes a plate connector, i.e., a plane made of any convenient conductive material, such as metal. In embodiments, the ends of the pin connectors on the handle assembly are biased to connect physically, and therefore electrically, to the corresponding plate connectors on the amplifier assembly. Embodiments of the handle assembly and amplifier assembly include any number of electrical connectors, for example, any number of pin connectors or plate connectors, where applicable, for example, one or more, for example five or more, for example ten or more, for example twenty or more, for example two, five, ten, twelve, sixteen, thirty-two, or sixty-four or more pins.

[0188] If present, the pin connectors of the handle assembly may be arranged in a substantially V-shaped pattern. In such embodiments, the tip or apex of the V-shaped pattern may be electrically connected to ground. When such arrangement is used to operably connect to an amplifier assembly having a plate connector, the plate connector may be arranged and configured to accept the V-shaped pattern of the pin connector. In such cases, the pins and plates may be arranged such that the electrical connection to ground is the initial electrical connection made when the amplifier assembly is operably connected to the handle assembly. For example, when the pin connector is connected in a V-shaped pattern with a ground connection at the tip or apex of the V, the first electrical connection made when the handle assembly is operably connected to the amplifier assembly is the ground connection. This is because the connector at the tip or apex of the V-shaped arrangement is positioned closest to the amplifier assembly when the two assemblies are operably connected (i.e., such pins are at the most distal position of the pins). In such cases, the pins and plates are arranged such that the electrical connection to ground is made before any other electrical connections are made when the amplifier assembly is operably connected to the handle assembly. Similarly, in the embodiment, the pins and plates are arranged such that the electrical connection to ground is the last electrical connection to be disconnected when the amplifier assembly is disconnected from the handle assembly. That is, in the embodiment, the pins and plates are arranged such that the electrical connection to ground is disconnected after all other electrical connections are disconnected when the amplifier assembly is disconnected from the handle assembly. Such an arrangement improves the safety of the device because the possibility of static electricity buildup or unintentional closed circuits is reduced, since the ground connection remains available until all other electrical connections between the handle assembly and the amplifier assembly are opened. System check

[0189] In some embodiments, the handle assembly is configured to perform one or more system self-checks. In some cases, the system self-check is performed before the oscillator is activated. For example, when the user initiates engagement or activation of the oscillator, the handle assembly is configured to automatically perform a self-check first. The system self-check in question may include, for example, detecting leaks from an energy source, such as determining whether a leak exists within or outside the handle assembly in one or more components. Embodiments of the handle assembly are configured to perform system checks relating to verifying the presence of correct or expected voltages and currents, verifying that voltages or currents are within acceptable limits, verifying the presence of electrical grounding, verifying that pre-programmed memory chip responses are as expected or specified, verifying that the cycle count is 0 or maximum, verifying that pressure sensor feedback is as expected or specified, and verifying that the occurrence of displacement and / or voltage and / or current changes (e.g., from displacement sensors such as Hall sensors) when fluid (gas or liquid) pressure is applied or removed is as expected or specified (i.e., whether the expected response is observed on the displacement sensor such as a Hall sensor when pressure is applied to or removed from the diaphragm). In embodiments, the handle assembly may be configured to perform system checks on its own, or to perform system checks together with an amplifier assembly itself that is configured to perform or facilitate such system checks. In certain embodiments, the amplifier assembly may be configured to perform system checks on its own and transmit the results of such system tests to the handle assembly or to other parts of the system such as an operablely connected computing device or computer tablet.

[0190] As described, embodiments of the handle assembly are configured to releasably engage with embodiments of the amplifier assembly so that the handle assembly is operably connected to the amplifier assembly. Such an operable connection allows for the transfer of energy from the handle assembly to the amplifier assembly. In some cases, such an operable connection further allows for an electrical connection between the handle assembly and the amplifier assembly, i.e., the joining of electrical connectors on the handle assembly and the amplifier assembly. Embodiments of the handle assembly of the present invention may include one or more safety features to ensure that proper connection of the system is established and to prevent operation when the handle assembly and the amplifier assembly are not properly connected, or one or more other safety features configured to prevent specific behavior of the handle assembly and / or the amplifier assembly and / or other parts of the system of the present invention. In particular, such safety features may be configured to prevent operation of the handle assembly and / or the amplifier assembly when the handle assembly is not releasably engaged with or operably connected to the amplifier assembly, i.e., not connected in a specified orientation that allows for the safe transfer of energy from the handle assembly to the amplifier assembly. Such safety features may include, for example, an interlock mechanism. In some embodiments, the handle assembly may include an interlock mechanism configured to prevent the handle assembly from transmitting energy when the amplifier assembly is not properly connected to or mounted to the handle assembly. If present, such an interlock mechanism may be configured to prevent one embodiment of the handle assembly from transmitting energy to the amplifier assembly, for example, if the amplifier assembly appears to be malfunctioning. For example, the handle assembly may be configured to anticipate a specified output from a displacement sensor (e.g., a Hall sensor) mounted on the diaphragm of the amplifier assembly when a specified amount of energy is transmitted by the handle assembly.When such a specified displacement of the diaphragm does not occur, the handle assembly may be configured to indicate an error condition and stop the transfer of energy to the amplifier assembly.

[0191] In some embodiments, such an interlock mechanism is configured to prevent energy from being transferred from the handle assembly to the amplifier assembly when the electrical connection between the handle assembly and the amplifier assembly is not connected, for example, when a designated circuit is open, or when a common ground is not connected or available.

[0192] In other embodiments, the handle assembly includes an interlock mechanism comprising an orientation element, such as a keying element, configured such that the amplifier assembly and the handle assembly can engage with each other in a manner that allows them to be released from each other only in a specified orientation, for example, to facilitate connections to a hydraulic system, for example, to a pressurized gas, and electrical connections.

[0193] User Interface The handle assembly may include, for example, user interface functions for use by the operator of the handle assembly and / or the system in which the handle assembly is part. Such functions may include input and / or output functions for receiving and transmitting information with the user, such as the operator.

[0194] In some cases, the user interface of the handle assembly may include an input device or operator control unit to facilitate treatment, such as one or more buttons, i.e., an operator control unit. For example, the user interface of the handle assembly may include an operator control unit for starting the oscillator of the handle assembly. If present, the input device may include one or more buttons configured to receive / read / detect user, e.g., operator, feedback or control information. The input function, e.g., one or more buttons, may be located in any convenient location outside the handle assembly, e.g., in a location selected to encourage the proper use of such input function, or in a location that is difficult to access, e.g., if the button is intended for use in rare situations and / or to avoid accidental pressing of such button.

[0195] In embodiments, the user interface of the handle assembly includes an output device, such as one or more lights, such as LED lights. Embodiments of the output device may include any visual or tactile elements for conveying information to the operator, such as any type of illumination or light, such as LED lights. In embodiments, lights such as LEDs may be used to convey information to a user, such as an operator, or to illuminate, i.e., highlight, a particular part of an amplifier assembly, or to convey information about the state of the handle assembly or the amplifier assembly or other parts of the system in which the handle assembly is part. In certain embodiments, one or more lights (e.g., LEDs) may be integrated with one or more input devices, such as buttons, as described above. In other embodiments, one or more lights (e.g., LEDs) may be multicolored (i.e., different current inputs produce different colors). When different colored lights are used, different colors may be used to provide information to the user, such as an operator, such as indicating different states or information. In other embodiments, one or more lights may emit different colors to indicate different states or information, and / or one or more lights (e.g., LEDs) may be integrated into the distal interface of the handle assembly and / or into a portion of the amplifier assembly. For example, the handle assembly and the amplifier assembly may include lights configured to be used in connection with oriented or positioning the two assemblies relative to each other, or in connection with signaling appropriate connections for operation. housing

[0196] Embodiments of the handle assembly further include a housing, where the manifold resides within the housing, and where other parts of the handle assembly reside within the housing, as well as different components of the handle assembly, may reside within a single housing. Such a housing may, if desired, substantially enclose the manifold and other components of the handle assembly. In embodiments, the housing is configured to enclose and protect the components held therein, i.e., to protect the internal components from exposure to the environment and / or from wear and deterioration caused by the ingress of foreign matter. The form of the housing may vary, but in some cases, the housing comprises one or more snap-fit ​​shells configured to substantially enclose the manifold and other components of the handle assembly, if desired.

[0197] In the embodiment, the housing optionally has a clamshell shape configured to enclose the manifold and other parts, and to provide protection to the components of the handle assembly within the housing from mechanical, electromagnetic, electrical, foreign matter, and fluids.

[0198] In some embodiments, the housing may be configured to provide a handheld unit. In such cases, the portable component, such as a portable handle assembly, is designed to be held and operated in one hand by an adult. In some embodiments, the housing may also be configured to improve the grip of the user, such as an operator.

[0199] In other embodiments, the housing is configured to act as a strain relief to ensure that the joint between the handle and the coupler assembly, or elements of the coupler assembly configured to operably connect, for example, the handle assembly and an energy source, are not damaged.

[0200] In certain cases, the housing may be injection-molded using a rigid, high-impact-strength thermoplastic resin to prevent damage to the handle assembly or its internal components.

[0201] The housing may be configured to fix the handle assembly in a specific “home” position. The housing may have one or more features to facilitate the storage of the handle assembly when not in use. For example, in some embodiments, the handle assembly may have one or more features to facilitate the storage of the handle assembly in, for example, a slot in the console to which the handle assembly is connected, so that the handle assembly can be protected when not in use. In other embodiments, the handle assembly or its housing includes a magnetic latch in which a ferromagnetic plate is integrated into the housing of the handle assembly, and a corresponding magnetic plate and molded slot are integrated into the positioning structure. When such embodiments of the handle assembly and such storage structure are in contact, the magnetic plate and slot align the handle assembly and / or its housing to its proper position and hold the handle assembly in place when not in use.

[0202] As described herein, the housing of the handle assembly and / or the distal interface of the handle assembly and / or other parts of the handle assembly may be configured to facilitate interface with the amplifier assembly. In one embodiment, openings (e.g., two, three, four, five or more openings) on the surface of the distal interface (e.g., a surface substantially perpendicular to the long axis of the handle assembly) or on the housing of the handle assembly may be conveniently configured to receive the mating and locking arms or snaps or other elements of the keyed interface of the amplifier assembly. Such openings may be circular or oval through holes or blind holes. Such openings may have grooves that compress the snaps or snap mating or flexible arms of the amplifier assembly while the amplifier assembly is inserted into the receptacle. The edges of such openings may hold the snaps or snap mating or flexible arms while the handle assembly and amplifier assembly are operating, for example, during the transmission of pulsed energy. In some embodiments, the orientation of the handle assembly and the operable connection to the amplifier assembly may be maintained by one or more of the following: screws, mechanical, magnetic, or electromechanical latches, push connections, etc., and these elements may be present in the distal interface of the handle and / or the housing of the handle assembly and / or other parts of the handle assembly.

[0203] Further details relating to parts of a handle assembly or related components that may be incorporated into or used in embodiments of the present invention are provided in U.S. Patent No. 11,464,949, pending PCT application PCT / US2020 / 055458, U.S. Patent Application No. 63274832, pending PCT application PCT / US2022 / 014785, U.S. Patent Application No. 63238381, pending PCT application PCT / US2022 / 040586, U.S. Patent Application No. 63346703, pending PCT application PCT / US23 / 23533, U.S. Patent Application No. 63346704, pending PCT application PCT / US23 / 22685, and U.S. Patent Application No. 63444414, the disclosures of which are incorporated herein by reference.

[0204] Various parts of the handle assembly of the present invention have been described in general above, and here the elements of the handle assembly will be further considered in the context of specific embodiments.

[0205] Specific Embodiments A handle assembly according to one embodiment of the present invention is shown in Figures 8A to 8F. Figures 8A to 8F show embodiments in which the housing is not in a fixed position so that the internal components can be visualized more easily.

[0206] Figure 8A shows an isometric view of the handle assembly 800, with the relatively distal region of the handle assembly 800 on the left side of the figure and the relatively proximal region of the handle assembly 800 on the right side of the figure.

[0207] The handle assembly 800 includes a distal interface 810. As described herein, the handle assembly in question interfaces with the amplifier assembly such that the distal interface 810 contacts and operably connects with the corresponding interface of the amplifier assembly (i.e., the proximal interface of the amplifier assembly), for example, the proximal nose 210 shown in Figure 2A.

[0208] The keying element 815 is positioned and shaped to align the handle assembly 800 with the corresponding keying element 227 (i.e., keyway) of the amplifier assembly 200 shown in Figure 2A. Such a keying structure operably connects the handle assembly 800 to the amplifier assembly and facilitates the circumferential, radial, and longitudinal alignment of such assemblies.

[0209] Furthermore, a bore 820 is located within the internal region of the distal interface 810. Bore 820 is the output of the handle assembly 800 and is configured to output energy, for example, pulsed energy or static energy in the form of, for example, high-pressure gas. Bore 820 is configured to interface with and operably connect to the high-voltage connector 223 of the amplifier assembly, in particular amplifier assembly 200.

[0210] The manifold 830 of the handle assembly 800 is operably connected to an energy source via a coupler assembly 850. The manifold 830 is configured to controllly transmit energy to the distal interface 810, i.e., its bore 820. The coupler assembly 850 is located in a relatively proximal region of the handle assembly 800 and is configured to operably connect to the energy source. As seen in the handle assembly 800, the path from the coupler assembly 850 to the bore 820 is substantially linear, and this configuration reduces energy dissipation compared to a relatively roundabout path. The receptacle 825, configured to accept the flexible snap-fit ​​arm of the amplifier assembly, is located on the opposite side of the distal interface 810.

[0211] Figure 8B shows a distal view of the handle assembly 800. The distal interface 810 comprises a bore 820 having a keying element 815 (i.e., a key) above it. The keying element 815 has a rounded outer edge, and this structure facilitates the alignment of the keying element 815 (as well as the distal interface 810 and bore 820) with the corresponding keying element 227 and high-voltage connector 223 of the amplifier assembly 200. Receptacles 825 are located on both sides of the distal interface 810.

[0212] Figure 8C shows a top view of the handle assembly 800. The length of the distal interface 810 is shown in this figure. The manifold 830 is shown above and is connected to the distal interface 810 in this figure. Above the manifold 830 is the coupler assembly 850. The coupler assembly is operably connected to an energy source (not shown). A substantially direct line is shown in this figure from the coupler assembly 850, where energy is input to the handle assembly 800, to the distal interface 810, where energy is output from the handle assembly 800.

[0213] Figure 8D shows a top cross-sectional view of the handle assembly 800. The depth of the central region of the distal interface 810 is shown in this figure. The bore 820 is located in a relatively central region of the distal interface 810. The manifold 830 is equipped with an oscillator, which is a solenoid 835 with a plunger that moves between two positions in the handle assembly 800. The first position is where the output of the coupler assembly 850 is connected to the bore 820, and the second position is where the output of the coupler assembly 850 is not connected to the bore 820. That is, in the first position of the solenoid 835, energy received from the energy source via the coupler assembly 850 is transmitted through the handle assembly 800 so that it is output at the bore 820 to the connected amplifier assembly, and in the second position of the solenoid 835, the energy received from the energy source via the coupler assembly 850 is discharged and is not output at the bore 820 to the connected amplifier assembly.

[0214] Figure 8E shows a side view of the handle assembly 800. The distal interface 810 is shown at the bottom of the figure, the manifold 830 is shown above the distal interface 810, and the coupler assembly 850 is shown above the manifold 830.

[0215] Figure 8F shows a side cross-sectional view of the handle assembly 800. The keying element 815 (i.e., the key) is located within the distal interface 810. The bore 820 is also located within the distal interface 810. The fluid connection between the bore 820 and the output of the solenoid 835 of the manifold 830 is shown in this cross-sectional view. The fluid connection between the solenoid 835 of the manifold 830 and the output of the coupler assembly 850 is also shown in this cross-sectional view.

[0216] Figures 9A to 9F show a handle assembly according to one embodiment of the present invention. In Figures 9A to 9F, elements having the same or similar reference numerals have the same or similar characteristics as the corresponding elements in Figures 8A to 8F unless otherwise specified.

[0217] Figure 9A shows a distal view of the handle assembly 900. Figures 9B to 9C show views of the handle assembly 900 from a viewpoint along the long axis of the handle assembly 900. The handle assembly 900 is shown with the housing 990 in its fixed position on the handle assembly 900. Figures 9D to 9E show isometric views of the handle assembly 900, with the relatively distal side of the handle assembly 900 shown on the left side of the figure and the relatively proximal side of the handle assembly 900 shown on the right side of the figure. Figure 9F shows a side cross-sectional view of the handle assembly 900.

[0218] The distal interface 910 is located on the distal surface of the handle assembly 900. Receptacles 925 for the holding snap of the flexible arm of the amplifier assembly are located on both sides of the distal interface 910. A bore 920 is located in the central region of the distal interface 920 and is configured so that the high-voltage connector of the amplifier assembly can engage with it. A keying mechanism 915 is also located within the distal interface 910 and is configured to engage with the corresponding keying mechanism of the amplifier assembly.

[0219] The housing 990 substantially covers the handle assembly 900 with the portion of the distal interface 910 and the pathway for the coupler assembly 950 exposed. Gripping points 992 are located on both sides of the handle assembly 900, with textured surfaces of the housing 990 configured for hand-operation of the handle assembly 900. A button 996 is located in the central region of the handle assembly for use in controlling the handle assembly, for example, engaging a solenoid 935 of the manifold 930. The button 996 is surrounded by an LED light 994 to provide output to the user (for example, a green light indicates that the handle assembly 900 is operating without error, a red light indicates that the handle assembly 900 is in an error state, and no light indicates that the handle assembly 900 is off).

[0220] Figures 9E to 9F show additional parts of the handle assembly 900. The coupler assembly 950 includes an input and discharge tube 955 located in the distal region of the handle assembly 900. The input and discharge tube 955 is operably connected to an energy source (not shown) and a discharge mechanism for safely receiving discharges. The manifold 930 includes an oscillator, which is a solenoid 935 that discharges energy when the solenoid 935 is in the "off" position. When the solenoid 935 is in the "on" position, energy is carried through the manifold 930 of the handle assembly 900 and output at the bore 920 of the distal interface 910. The connector 957 is located at the proximal end of the input and discharge tube 955. A system for supplying pulsed energy

[0221] As outlined above, a system for supplying pulsed energy is provided. Parts of the system include an amplifier assembly, such as the amplifier assembly described herein, and a handle assembly, such as the amplifier assembly described herein. Some embodiments of the system further include a console assembly having an energy source operably connected to the handle assembly.

[0222] The system or components of the present invention may be configured to be reusable or disposable, as desired. If the system (or part thereof) of the present invention is reusable and may come into contact with a patient area, such embodiments may be configured to be covered with a disposable sterile sleeve or bag so that the system can be used without contaminating the sterile field of the operating room.

[0223] Console Assembly In embodiments, the system of the present invention includes a console assembly. The console assembly, also called a console unit or console subsystem, is used in embodiments of the system according to the present invention to generate the power and control necessary for, for example, the treatment of cardiovascular tissue.

[0224] Embodiments of the console assembly of the system according to the present invention include an energy source. The energy source of the embodiment of the present invention is configured to provide energy which can be adjusted as desired by a regulator. Any convenient energy source may be used, and examples of energy sources include voltage sources, pressure sources, electromagnetic sources, electric field sources, chemical sources, etc. In some embodiments, the energy source is a pressure source, and examples of suitable pressure sources include, but are not limited to, compressed gas cylinders, compressors, etc. Optionally, the energy source may be operably coupled to a regulator which plays a role in converting the energy from the energy source into a suitable form so that it can be further acted upon by, for example, an oscillator in a manifold assembly. For example, if the energy source is a high-pressure gas source, the regulator may play a role in adjusting the gas pressure to a suitable value which can be input to the oscillator. In addition to positive energy sources (e.g., high-pressure gas), the energy source of interest may also include an energy source configured to provide a negative potential compared to a reference or standard potential, for example, a vacuum potential compared to standard atmospheric conditions.

[0225] In some embodiments, the console assembly comprises two or more energy sources. In embodiments comprising two or more energy sources, the energy supplied by each energy source may all be of the same type, or it may be a combination of different energy types. For example, each energy source may be a pressure source (at the same or different potential levels), or one energy source may be a pressure source and another may be a voltage source.

[0226] In embodiments, the console assembly may further comprise one or more regulators (i.e., power regulators), an output port, and a controller. With respect to the power regulator, as described above, in embodiments, the energy of the energy source may be adjusted from a first input energy to a second energy, e.g., the transfer of energy to the oscillator of the manifold assembly, and ultimately to an energy suitable for treating, for example, cardiovascular tissue. The energy of the energy source may be adjusted to a predetermined value, a user-defined value, or to a variety of feedback inputs that occur during treatment. In some cases, the energy of the energy source may be adjusted dynamically, at least in part, based on conditions related to treatment involving the delivery of pulsed energy to tissue, e.g., cardiovascular tissue, based on, for example, changes in tissue compliance during treatment, as described herein. In some cases, the energy of the energy source may be adjusted in real time or substantially in real time. In certain embodiments, the energy of the energy source may be adjusted to an optimal value for a particular treatment. For example, the energy of the energy source may be adjusted to an optimal value for treating diseased cardiovascular tissue and for treating diseased peripheral tissue. In some cases, one or more inputs from the console assembly, amplifier assembly, or handle assembly, or from an external source of the system (e.g., other measurements of the subject, such as imaging of the subject), may be used to determine and then adjust to optimal treatment conditions, such as the output energy of an energy source suitable for the desired treatment.

[0227] In embodiments comprising a regulator configured to adjust the energy of an energy source (i.e., a power regulator or a potential regulator), such a regulator may be a passive regulator (i.e., a regulator that is pre-set or adjusted by the user) or an active regulator (i.e., a regulator that is controlled by, for example, an electrical impulse or other dynamic signal from a controller). The regulator in question may include regulators typically used for fluid regulation, such as directional valves or diaphragm valves; regulators typically used for electrical regulation, such as voltage regulators; regulators typically used for optical output regulation, and the like. In embodiments comprising two or more energy sources, the potentials of the various energy sources may be adjusted together or separately.

[0228] In the embodiment, regulated and / or unregulated energy (e.g., potential energy) from an energy source is output through an output port operably coupled to the manifold of the system's handle assembly. Any convenient output port, such as commercially available connectors, including pneumatic, hydraulic, electrical, or optical connectors, may be used in the embodiment. In certain examples, the unregulated or regulated potential energy may be converted to another energy form before or possibly after the energy is passed to or otherwise transmitted to the manifold of the handle assembly.

[0229] In some cases, a console assembly may include two or more physically separate or connected units, i.e., each console unit, that can be operably interconnected (e.g., electrically, fluidly, using radio frequency (RF), etc.). That is, a console assembly may comprise a single assembly or two or more separate operably connected units.

[0230] In some cases, at least some of the console assembly components reside in a unit configured to be handheld or operable, for example, to be moved by hand. The form factor of such a unit may vary as desired, but in some cases, such a unit may be substantially configured as a rectangular box having a height in the range of 10 cm to 100 cm, such as 20 cm to 30 cm; a width in the range of 5 cm to 100 cm, such as 10 cm to 20 cm; a depth in the range of 10 cm to 100 cm, such as 20 cm to 30 cm; and a mass in the range of 1 kg to 20 kg, such as 5 kg to 8 kg.

[0231] In one embodiment, the console assembly may include a first console component that houses an energy source, such as a pressure source, and a regulator and actuator for the pressure source, such as an operable button. The console assembly may optionally include electrical connectors for providing electrical connections to various other components of the system. For example, electrical connectors may be used to power sensors configured to receive data, for example, regarding balloon pressure or volume measurement, and to collect such data during treatment using the system.

[0232] In some cases, at least some of the console assembly components reside in a mountable unit configured to be positioned or fixed on or near an operating table close to the subject, i.e., the patient, so that the 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 the operating room and can communicate with the system remotely via a remote control). In such examples, the mountable unit is designed to be easily clamped, fixed, or independently stable on or near the operating table and can be operated by a remote control unit. In such examples, the mountable unit may include a communicator that provides communication between the console assembly and other controllers located within or outside the system, the communicator may be implemented by any desired hardware and / or software configuration and may be configured to communicate using wired or wireless protocols.

[0233] The console assembly and / or its energy source used in the system of the present invention may be configured to be reusable or disposable, as desired. The console assembly used in the system of the present invention may be configured to accept a sterile sleeve so that the console assembly can be used without contaminating the sterile field of the operating room.

[0234] controller Embodiments of the console assembly of the system according to the present invention include a control subsystem, also called a controller or control assembly. Embodiments of the system may utilize a controller to control the amount and duration of energy delivered to tissue, such as cardiovascular tissue. In some cases, embodiments of the system may utilize a controller to measure the therapeutic effect on cardiovascular tissue, such as the degree of calcification of the tissue, such as cardiovascular tissue compliance, as described herein. In embodiments, the control assembly may reside in other components of the system, such as a handle assembly, or may be distributed among multiple components of the system, such as a console assembly and a handle assembly.

[0235] In embodiments, the control subsystem may be connected to one or more parts of a console assembly (such as a pressure source or regulator), a handle assembly (such as an oscillator), or an amplifier assembly, to receive information from there and / or adjust (i.e., control) it. The control subsystem may also be configured to receive information from and / or control external systems such as an electrocardiograph (ECG), intravascular or external pressure monitor, blood volume sensor, patient vital sensor, or imaging system such as an imaging system utilizing fluoroscopy, intravascular ultrasound (IVUS), or optical coherence tomography (OCT). Furthermore, the control subsystem may comprise a plurality of control units interconnected so that one or more of the units communicate synchronously with one another.

[0236] In some cases, the control subsystem (or a control unit comprising the control subsystem) may be configured to communicate with components of the system so that the energy transmitted through the amplifier assembly is appropriate, i.e., appropriate for a particular treatment involving the application of pulsed energy to a tissue, such as cardiovascular tissue.

[0237] In one embodiment, the controller is configured to receive a treatment plan, i.e., control instructions related to a specific treatment for a particular treatment of a subject. The treatment plan may include, for example, a specified potential amount, the frequency or duty cycle of the oscillator of the handle assembly. Furthermore, the treatment plan may include information about the type of pulsed balloon or other tissue engagement element to be used, such as its size or orientation. Further details regarding the treatment plan, the control system, and updating the behavior of the catheter-based procedure based on data collected about the procedure are described in U.S. Patent Application No. 63346704 and pending PCT Application No. PCT / US23 / 22685, the disclosures of which are incorporated herein by reference.

[0238] In some embodiments, the controller may be configured to provide feedback to the operator of the system of the present invention in any convenient manner. In some cases, the controller may be configured to provide tactile feedback to the operator, for example, by vibration. For example, the controller may be configured to vibrate a handle or other interface with the system operator in response to important changes or decisions, such as sensor measurements, for example, changes in cardiovascular tissue compliance. Such tactile feedback may be used in connection with indicating to the operator of one embodiment of the system that the system configuration should be changed.

[0239] In embodiments, the control assembly is configured to perform a system workflow, i.e., to interact with the operator, so that the system can be used, for example, to deliver pulsed energy specified by the operator for use in a procedure. The control assembly may include hardware devices such as one or more processors, each operably connected to one or more memories containing instructions to cause the processors to perform such a system workflow when executed by the processors. The processors and memory devices in question may include commercially available general-purpose processors or controllers or microcontrollers or application-specific integrated circuits.

[0240] Figure 10A shows a flowchart 1000 comprising a system activity diagram showing the software state of the system control assembly in each case according to embodiments of the present invention. The workflow 1000 shows the states of the system controller and the transitions between them, from the startup state 1010 through the unprepared state 1020 to the ready state 1030. Such system controller states and the transitions between them are related to specific designated interactions with the user, i.e., the operator, such as when the operator turns on the system under specific circumstances within the startup state 1010. Such system controller states and the transitions between them are also related to system functions and system behaviors, such as the system performing a prime check under specific circumstances within the ready state 1030.

[0241] In particular, flowchart 1000 illustrates how a system according to one embodiment of the present invention interacts with its various components. During startup, corresponding to the startup state 1010, the user interacts with the system by connecting the power supply and turning on the system. The console and handle (if installed) perform internal safety checks in each case of the system. These safety checks may include, for example, electrical and signal integrity checks, display integrity checks, pneumatic input, output, discharge, and connection tests, and / or maintenance checks. While such checks are being performed or afterward, an operation screen may be displayed to provide the user with feedback on the operating status of the system. One requirement the system may provide to the user is to connect an energy source (in this case, a CO2 tank) to the system and pressurize it. Once pressurized, the system senses the pressure by continuous checks to ensure the integrity of the pressure input. Furthermore, the user is prompted to prepare the catheter, cover the handle with a sterile sleeve, and, when ready, install the catheter. These actions are part of the unready state 1020 in flowchart 1000, which corresponds to a system controller state in which the system is not ready to initiate pulsed energy or is not ready to perform any other action using the system.

[0242] When the system has amplifier assemblies and / or catheter assemblies operably connected to or otherwise attached to the system (for example, an operable connection between a handle assembly and an amplifier assembly, as described herein), the system is configured to recognize the amplifier assemblies and / or catheter assemblies and perform pre-treatment safety checks. That is, a control assembly may be configured to perform such safety checks related to a part of the system (for example, it may have software programmed to do so). Such amplifier assemblies and / or catheter assemblies may be called disposable or disposable components if the system is configured not to reuse such amplifier assemblies and / or catheter assemblies between uses or between procedures performed by the system (i.e., discard them).

[0243] Such safety checks relating to disposable components, i.e., amplifier assemblies and / or catheter assemblies, include, for example, electrical integrity checks, minimum or maximum pressure checks, pneumatic integrity checks including inlet, outlet, and discharge ports, lifecycle and previous use and / or connection tests, prime checks, adaptation or use case checks, and / or burst pressure rating checks.

[0244] When the controller receives feedback such as sensor data, and this coincides with confirmation that the amplifier assembly and / or catheter assembly have passed such safety checks, flowchart 1000 transitions to a ready state 1030, where the system prompts the user to prime the catheter and press a button, for example, located on the handle assembly, when the system is ready to perform treatment, i.e., when it is ready to begin treatment. Once such a button is pressed or other input is received from the user indicating that the procedure should be started, the system proceeds through flowchart 1000 and performs additional checks, for example, electrical integrity checks, minimum or maximum pressure checks, pneumatic integrity checks including inlet, outlet and discharge ports, lifecycle and previous use and / or connection tests, priming checks, adaptation or use case checks, burst pressure rating checks, and / or initial pressure tests. The control assembly may be configured to perform such checks simultaneously or substantially simultaneously or sequentially or continuously iteratively.

[0245] Furthermore, the control assembly may be configured to allow the system to track and record various system states and sensor values ​​before, during, or after treatment using the system, for purposes such as continuous learning, maintenance checks, and data tagging. Such data may be stored in local or distributed memory, transferred to an external computing device such as a computer table, or uploaded to cloud-based storage.

[0246] Figures 10B-1 to 10B-5 show flowchart 1000B of another embodiment of software control of the system according to the present invention.

[0247] An exemplary graphical user interface screen according to an embodiment of the present invention is shown in Figure 10C. In embodiments of the system of the present invention, one or more elements may comprise a display screen. In a particular embodiment, the console unit comprises a display screen and associated hardware and software configured to present the graphical user interface 1050. The graphical user interface 1050 is separated into a plurality of boxes or panes. The treatment pane 1054 of the graphical user interface 1050 is included to provide countdown and timeout information until the execution of a treatment (e.g., forced pause of the execution of a treatment). When the system is able to treat, i.e., perform a procedure, i.e., generate and transmit pulsed energy, the text in the treatment pane 1054 appears in a specific color, e.g., white. When the system is unable to treat, the text in the treatment pane 1054 appears in a different color, e.g., gray (but is still visible). When the system is engaged to perform a treatment, a countdown from the maximum allowable continuous treatment time to zero is displayed in the treatment pane 1054. In the treatment pane 1054, 45 seconds remain in the countdown time. After treating for the maximum allowable treatment time, the treatment pane 1054 displays a countdown to reflect the system timeout that prevented the treatment from being performed. The top of the treatment pane 1054 displays the text "Execute," which may also be updated to reflect the number of timeouts.

[0248] The priming pane 1053 of the graphical user interface 1050 is highlighted when the system instructs the operator or user to prime the system's catheter assembly. When the system is not instructing the operator to prime the catheter assembly, the displayed gauges and associated text in the priming pane 1053 are displayed in different colors or intensities, for example, grayed out, and in some cases, the text of the priming pressure value is replaced with another symbol, for example, "--".

[0249] The system status pane 1051 of the graphical user interface 1050 is updated to provide information on the system status and / or software status and / or controller status. The graphical user interface 1050 may also be configured to display a logo in the system status pane 1051.

[0250] The total catheter life pane 1055 of the graphical user interface 1050 includes a count-up bar from zero to the allowable total therapeutic life of the catheter in the system. In embodiments of the graphical user interface 1050, such a bar is filled with a specified color, for example yellow, and moves from left to right until a dot of such color, for example yellow, reaches the vertical line on the right side of the total catheter life pane 1055.

[0251] If the system's catheter is used without being removed, the total catheter life pane 1055 displays the interval between pulse cycles. In embodiments, a pulse cycle is the duration of continuous treatment (i.e., the length of time from when the operator presses a button (i.e., a button on the system's handle assembly configured to initiate treatment) until they release it). In embodiments, the maximum pulse cycle time is the maximum allowable continuous treatment time (the amount of which corresponds to 45 seconds, as shown in the treatment pane 1054). If the operator removes and reinstalls the pulsed catheter assembly, no such interval exists, but the bar in the catheter life pane 1055 is displayed in a specified color, e.g., yellow, and the dot is in a specified position. In embodiments, the system may be configured not to record when pulse cycles occurred in the catheter assembly software, but instead to record the total number of pulses applied by the system.

[0252] The notification pane 1056 of the graphical user interface 1050 provides additional information about the use, state, or status of the system for the operator, i.e., the user. In embodiments, the color of the notification pane 1056 reflects the system status; that is, the color of the notification pane 1056 may change based on the system status or state. In embodiments, the color of the notification pane 1056 may be selected to match the color of the LEDs of the buttons on the handle assembly, if present.

[0253] The subsystem status pane 1052 of the graphical user interface 1050 provides a single location for all information on each subsystem of the system (e.g., the operational status and / or error status of different subsystems of the system). Such information is distributed across the catheter subpane, handle subpane, console subpane, and CO2 tank subpane.

[0254] In the Catheter subpane of the subsystem status pane 1052, the color of the catheter icon indicates the status of the catheter. For example, in an embodiment, a catheter may appear gray to indicate that the catheter is not connected, green to indicate that the catheter is operational, and orange to indicate that an error has occurred and / or to instruct the operator, i.e., the user, to replace the catheter. In an embodiment, the Catheter subpane of the subsystem status pane 1052 may indicate connected / disconnected based on the mounting status of the catheter assembly in the system. In an embodiment, balloon length and / or diameter information may be updated based on which information is retrieved from the catheter assembly (i.e., the amplifier assembly in the system has memory that can be read by the system). In an embodiment, the balloon status may have three states (i.e., not primed, primed, or in treatment) and may be reflected in this part of the graphical user interface 1050. In an embodiment, the pulse count value is updated when the system is performing treatment, and this value may match the value displayed in the total catheter life pane 1055.

[0255] In the Handle subpane of the subsystem status pane 1052, the color of the handle icon indicates the status of the system's handle assembly. For example, a handle may be displayed in a specified color, such as green to indicate that the catheter is operational, or in another color, such as orange, to indicate that an error has occurred or that the handle assembly is not intended to be detached under normal use, or in yet another color, such as red, to indicate that an internal error has occurred and the operator should contact support. The Handle subpane of the subsystem status pane 1052 may further provide the connection status of the handle assembly.

[0256] In the console sub-pane of the subsystem status pane 1052, the color of the console icon indicates the status of the console assembly of the system. For example, the console may be displayed in a specified color, for example, in green to indicate that the console is operational, or in another color, such as orange, to indicate that an error has occurred, or in yet another color, such as red, to indicate that an internal error has occurred and the operator should contact the support desk. The console sub-pane of the subsystem status pane 1052 may further provide the connection status of the console assembly.

[0257] In the CO2 tank sub-pane of the subsystem status pane 1052, the graphical user interface 1050 is configured such that the tank icon fill level reflects the tank pressure. In an embodiment of the tank sub-pane of the subsystem status pane 1052, a specified color, for example green, indicates that the pressure is at a sufficient level. Another specified color, for example orange, indicates that the pressure is low, so that the operator, i.e., the user, can proceed to use the system but needs to replace the energy source, for example the CO2 tank, soon. Yet another color, for example red, indicates that the pressure is too low and the energy source, for example the CO2 tank, needs to be replaced.

[0258] Graphical user interface 1050 is further configured or designed such that an error state is displayed as a pop-up, for example, a pop-up box on a display. In embodiments, the color of the pop-up reflects the urgency level of the notification. For example, in an embodiment, a pop-up / notification of a designated color, such as blue, is associated with a normal work item that instructs a user to perform a task. A pop-up / notification of another color, such as orange, is associated with the need for user response. Text may be presented in the pop-up to provide guidance for the operator to correct the error state. Yet another color, such as red, indicates that an internal error has occurred and the operator should contact the support desk. In embodiments, the notification pane 1056 reflects a color associated with the system state. For example, a green notification pane 1056 indicates a system state that is ready to perform a treatment and / or is performing a treatment.

[0259] Figure 11 shows a portion of a system according to an embodiment of the present invention. In Figure 11, elements having the same or similar reference numerals have the same or similar features as the corresponding elements in Figures 1A to 1D, unless otherwise specified.

[0260] The system 1102 includes a handle assembly 1101 shown in a perspective isometric view. The handle 1101 is oriented relative to the amplifier assembly 1100 to show how the handle assembly 1101 can be operatively connected to the amplifier assembly 1100. The amplifier assembly 1100 is also shown in a perspective cross-sectional isometric view, such that the distal region of the amplifier assembly 1100 is shown on the right side of the drawing. The console assembly 1103 is shown in a cross-sectional isometric view. The console assembly 1103 may be operatively connected to the handle assembly 1101 such that pulsed energy, for example pressurized fluid, is transmitted from the console assembly 1103 to the handle assembly 1101. The console assembly 1103 is also connected to a CO2 tank 1104 which is the energy source of the system 1102.

[0261] Figure 11 also shows an embodiment of system 1102 configured to enable and / or perform system safety checks. Such safety checks are designed to ensure that system 1102 does not damage downstream components. System 1102 is configured to perform safety checks relating to: that system 1102 has appropriate ratings and that a connector hose from the tank to the console is secured by utilizing an internal connector to prevent connection to other gas / tank styles; that a pressure check valve is present to prevent user exposure to gas in the event of accidental or intentional disconnection of the tank or other energy source; that the check valve inlet is utilized to prevent contamination of the pneumatic system; that a mechanical regulator with preset inlet, tank, and / or outlet pressure sensors is utilized to ensure appropriate inlet and outlet pressures; that an electronic regulator / proportional control valve is utilized to allow system 1102 to control the outlet pressure (in certain embodiments, the mechanical and electronic regulators may be combined in a single unit / manifold); and that the output of the electronic regulator is the pressure in the handle and The system has built-in safety checks, including the use of a handle pressure sensor to ensure matching, solenoid cracking pressure being taken into account so that even if a very high-pressure fluid flows downstream, the solenoid of the console assembly 1103 will not output pressure downstream, but instead discharge the fluid as a pressure relief valve, a solenoid control unit is used so that the sensor prevents the solenoid from operating if the handle pressure sensor is out of range, i.e., outside the expected or acceptable range, and the amplifier 1100 is configured to signal or notify the system 1102 (i.e., the controller for the system 1102) of the normal therapeutic pressure, the maximum acceptable pressure, and the lifecycle of disposable components (e.g., amplifier assembly 1100 and / or catheter assembly).In the event of a balloon burst, a Hall sensor integrated into the diaphragm of the amplifier 1100 is configured to detect the burst, preventing further treatment by the hardware in the handle 1101 (e.g., a comparator for known voltages), i.e., preventing further energy transfer to the amplifier assembly 1100.

[0262] A system for supplying pulsed energy according to one embodiment of the present invention is shown in Figure 12. System 1202 includes an amplifier subsystem or assembly 1200 and a handle subsystem or assembly 1201. The amplifier subsystem or assembly 1200 and the handle subsystem or assembly 1201 are connected so that electrical signals, power, or ground, as well as pneumatic energy, can be transmitted between such assemblies.

[0263] The amplifier subsystem 1200 is operably connected to the catheter subsystem or assembly 1205. The catheter subsystem 1205 includes tissue engagement elements (not shown), such as a distal balloon or cardiac tissue fitting element.

[0264] The handle subsystem or assembly 1201 is operably connected to the console 1203 so that electrical signals, power, or ground and pneumatic energy can be transmitted between such components. The console subsystem 1203 receives energy in the form of pressurized gas from the gas tank 1204. The console subsystem 1203 is also operably connected to the power supply 1206.

[0265] System 1202 is shown in a schematic form to illustrate the system's exploded view. As described, system 1202 has four main subsystems: (1) console subsystem 1203, (2) handle subsystem 1201, (3) amplifier subsystem 1200, and (4) catheter subsystem 1205. These subsystems work together with an external power supply 1206 and an energy source 1204 (in this case, pressurized gas) to produce a pulsed intravascular lithotripsy effect.

[0266] The console subsystem 1203 is configured to manage the adjustment and setting of power, electrical signals, and energy output. The handle subsystem 1201 is configured to manage the output and discharge of energy, as well as the reading of user input to the system 1202. The amplifier subsystem 1200 receives output energy from the handle subsystem 1201, converts that energy into a hydraulic shock, and directs that shock to the catheter subsystem 1205. The amplifier subsystem 1200 also manages and reads several sensors to ensure safe treatment. The catheter subsystem 1205 receives the shock from the amplifier 1200, transmits it through the catheter tube, and delivers energy from the distal balloon to calcium, for example, the lesion, while minimizing attenuation of the input signal.

[0267] For example, further details regarding parts of a system for providing pulsed energy or related components that may be incorporated into or used in embodiments of the present invention, including further details regarding parts such as console units, energy sources, oscillators, and regulators, can be found in U.S. Patent No. 11,464,949, pending PCT application PCT / US2020 / 055458, U.S. Patent Application No. 63274832, pending PCT application The disclosures provided in PCT / US2022 / 014785, U.S. Patent Application No. 63238381, Pending PCT Application No. PCT / US2022 / 040586, U.S. Patent Application No. 63346703, Pending PCT Application No. PCT / US23 / 23533, U.S. Patent Application No. 63346704, Pending PCT Application No. PCT / US23 / 22685, and U.S. Patent Application No. 63444414 are incorporated herein by reference.

[0268] method The system of the present invention has a variety of applications. In some cases, the system is used to break up hardened material embedded in elastic conduits. With respect to the embodiments presented herein, this disclosure describes applications related to treating atherosclerotic calcification in arterial conduits such as coronary or peripheral arteries. However, the system and teachings are not limited to atherosclerotic calcification or arterial conduits and may be applied to other applications as determined by those skilled in the art. For example, this is particularly true in situations involving medical interventions such as altering arterial compliance (i.e., vascular compliance of an artery) or when occlusion occurs after the placement of a previous stent. Vascular compliance is altered by the intraluminal placement of a previous stent. Data and feedback from vascular compliance curves may be used in relation to future treatments, as well as for predictive techniques such as machine learning techniques.

[0269] In some cases, various embodiments of the systems described herein are used in methods of dynamic balloon angioplasty (DBA), i.e., techniques that use generalized waveform pressure oscillations (in some embodiments, harmonic or frequency-specific pressure waveform oscillations) to effectively and safely fragment calcified lesions during angioplasty. In some cases, various embodiments of the systems described herein are used in vivo in assessment methods of vascular compliance, which is a measurable characteristic of a vessel calculated based on the ratio of the change in vascular volume to a given change in pressure. The system according to the present invention may be configured to assess vascular compliance by obtaining in vivo measurements of volume change at different pressures (or changes in pressure) applied to a vessel. Such measurements of vascular compliance can be performed, for example, during treatment.

[0270] Methods for delivering pulsed energy to tissue are also provided and are equally useful in the applications described herein. The method according to the present invention comprises deploying a system comprising an amplifier assembly and a handle assembly, as described herein, such that a tissue engagement element operably connected to the system is adjacent to the tissue. The components of the system, amplifier assembly, and handle assembly are described in detail above. A tissue engagement element means any therapeutic element capable of receiving pulsed or static energy in a form delivered by the amplifier assembly. The tissue engagement element is configured for use in the treatment of affected tissue. Examples of tissue engagement elements include distal balloons such as compliant or non-compliant distal balloons or variations thereof, or cardiac tissue-fitting elements.

[0271] The method according to the present invention further comprises engaging the system to energize tissue. For example, such a method may comprise imparting pulsed energy to the tissue or imparting static energy to the tissue (i.e., by inflating the distal balloon to static pressure or static volume over a period of time). In embodiments, imparting pulsed energy means repeatedly pressurizing the distal region of the amplifier assembly (e.g., the distal chamber). For example, the distal chamber of the distal waveguide is repeatedly subjected to pressure oscillations transmitted from the handle assembly through the amplifier assembly at any convenient amplitude, frequency, duty cycle, and duration. Such pressure oscillations originate from the handle assembly and are transmitted thereto to the amplifier assembly, as described in detail above in relation to embodiments of the system and the amplifier and handle assemblies. Any suitable amplitude, frequency, duty cycle, and duration of the pressure oscillations may be used and may vary.

[0272] These methods may be used to deliver pulsed energy to tissue locations in any number of different subjects. In some cases, the subjects are “mammals” or “mammals,” terms widely used to describe organisms belonging to the class Mammalia, which includes Carnivora (e.g., dogs and cats), Rodentia (e.g., mice, guinea pigs and rats), and Primates (e.g., humans, chimpanzees and monkeys). In some cases, the subjects are humans.

[0273] Further details regarding the methods by which embodiments of the present invention may be used, including further details relating to dynamic balloon angioplasty (DBA) and vascular compliance, are provided in U.S. Patent No. 11,464,949, pending PCT application PCT / US2020 / 055458, U.S. Patent Application No. 63274832, pending PCT application PCT / US2022 / 014785, U.S. Patent Application No. 63238381, pending PCT application PCT / US2022 / 040586, U.S. Patent Application No. 63346703, pending PCT application PCT / US23 / 23533, U.S. Patent Application No. 63346704, pending PCT application PCT / US23 / 22685, and U.S. Patent Application No. 63444414, the disclosures of which are incorporated herein by reference.

[0274] kit Furthermore, kits are also provided that include assemblies or systems or one or more of their components, such as those described above. Thus, a kit may, in some cases, include one or more of an amplifier assembly or a handle assembly or a system comprising an amplifier assembly and a handle assembly, each of which may or may not include a console and / or an energy source, such as a pressure source, or its components. Kit components may, if desired, be present in sterile packaging. Kit components may, if desired, be disposable or reusable. In some cases, a kit may comprise multiple components, including multiple versions of the same component in different sizes, such as multiple amplifier assemblies or multiple catheters of various sizes.

[0275] The kit may also include instructions for using the kit components. The instructions may be recorded on a suitable recording medium. For example, the instructions may be printed on a substrate such as paper or plastic. Accordingly, the instructions may be present in the kit as a package insert, on a label of the kit's container or a component thereof (i.e., associated with the package or sub-package). In other embodiments, the instructions exist as an electronically stored data file present on a suitable computer-readable storage medium, such as a portable flash drive, DVD, or CD-ROM. The instructions may take any form, including complete instructions on how to use the device, or as a website address by which instructions posted on the World Wide Web can be accessed.

[0276] The following exemplary embodiments are provided by way of illustration and not limitation. Additional Exemplary Embodiments

[0277] Figure 13 shows an exemplary embodiment of a prototype of a proximal nose 1300 of an amplifier assembly according to the present invention. The proximal nose 1300 includes a high-pressure connector 1301. The proximal nose 1300 and the high-pressure connector are formed from different materials (plastic and metal, respectively).

[0278] Figure 14 shows an exemplary embodiment of a prototype of a distal waveguide 1400 of an amplifier assembly according to the present invention. The distal waveguide 1400 has a substantially bell-jar shape with a proximal face 1401 present on the proximal side of the distal waveguide 1400.

[0279] Figures 15A and 15B show exemplary embodiments of a prototype diaphragm 1500 of an amplifier assembly according to the present invention. The diaphragm 1500 is integrated with a Hall sensor and associated electronics assembly 1501. The Hall sensor 1500 includes a probe 1502 located near the center of the diaphragm 1500. The diaphragm 1500 has a shape with pleats or folds 1503 so as to be configured to translate between the distal surface of the proximal nose and the proximal surface of the distal waveguide without causing distortion to the diaphragm 1500.

[0280] Figure 16 shows an exemplary embodiment of a prototype proximal nose 1600 of an amplifier assembly according to the present invention. The proximal nose 1600 is integrated with the electronics package 1602 of the diaphragm 1601.

[0281] Figures 17A to 17D show an assembly of the amplifier assembly 1700 according to the present invention. The amplifier assembly 1700 includes an electronics assembly 1702. The electronics assembly 1702 includes a connector plate 1703 facing the outer surface of the amplifier assembly 1700 so that the amplifier assembly 1700 can be securely associated with a handle assembly (not shown), and such an electrical connector interconnected with the corresponding connector of the handle assembly. The amplifier assembly 1700 also includes a pin 1704 inserted through the amplifier assembly 1700 to compress a diaphragm (not shown) between the proximal nose and the distal waveguide, thereby sealing the proximal chamber from the distal chamber. The amplifier assembly 1700 includes a high-voltage connector having an O-ring 1705.

[0282] Notwithstanding the attached claims, this disclosure is also defined by the following clauses: 1. A proximal nose with a distal surface, A distal waveguide having a proximal surface, It comprises a diaphragm that is compressed between the proximal nose and the distal waveguide, thereby sealing the proximal chamber from the distal chamber, An amplifier assembly in which the diaphragm is configured to translate between the distal surface of the proximal nose and the proximal surface of the distal waveguide without causing distortion to the diaphragm. 2. The amplifier assembly of clause 1, wherein the proximal chamber is defined by a first volume between the diaphragm and the distal surface of the proximal nose. 3. An amplifier assembly of any of the preceding clauses, wherein the distal chamber is defined by a second volume between the diaphragm and the proximal surface of the distal waveguide. 4. An amplifier assembly of any of the preceding clauses, wherein the diaphragm is configured to occupy different positions between the distal surface of the proximal nose and the proximal surface of the distal waveguide. 5. An amplifier assembly of any of the preceding clauses, wherein the diaphragm is configured to occupy different positions between the distal surface of the proximal nose and the proximal surface of the distal waveguide without causing distortion in the diaphragm material. 6. An amplifier assembly of any of the preceding clauses, wherein the diaphragm is adapted to a new shape and is configured to occupy different positions between the distal surface of the proximal nose and the proximal surface of the distal waveguide. 7. An amplifier assembly according to any of the preceding clauses, wherein the diaphragm is configured to fit the distal surface of the proximal nose at the proximal position of the diaphragm and to fit the proximal surface of the distal waveguide at the distal position of the diaphragm. 8. The amplifier assembly of Clause 7, having a shape such that the diaphragm fits the distal surface of the proximal nose at the proximal position of the diaphragm and the proximal surface of the distal waveguide at the distal position of the diaphragm. 9. An amplifier assembly of any of the preceding clauses, wherein the diaphragm is foldable. 10. An amplifier assembly of any of the preceding clauses, wherein the diaphragm is pleated. 11. An amplifier assembly of any of the preceding clauses, wherein the diaphragm is equipped with a pleated bellows. 12. An amplifier assembly according to any of the preceding clauses, wherein the diaphragm has a shape that fits into a recess on the distal surface of the proximal nose and a recess on the proximal surface of the distal waveguide. 13. An amplifier assembly according to any of the preceding clauses, wherein the diaphragm is not subjected to distortion and is not subjected to tension. 14. An amplifier assembly according to any of the preceding clauses, wherein the diaphragm is not subjected to distortion and the diaphragm material is not stretched. 15. An amplifier assembly of any of the preceding clauses, wherein the diaphragm is configured to translate without resistance from the diaphragm material. 16. An amplifier assembly according to any of the preceding clauses, wherein the diaphragm is configured to translate without applying stress to the diaphragm material. 17. An amplifier assembly of any of the preceding clauses, in which the outer ring of the diaphragm seals the interface between the proximal nose and the distal waveguide. 18. An amplifier assembly according to any of the preceding clauses, comprising a circumferential projection configured such that the diaphragm maintains its sealing while translating between the distal surface of the proximal nose and the proximal surface of the distal waveguide. 19. The amplifier assembly according to clause 18, wherein the circumferential projection is a T-shaped edge. 20. An amplifier assembly of any of the preceding clauses, wherein the proximal nose has a proximal interface located in the proximal region of the proximal nose. 21. An amplifier assembly according to clause 20, wherein the proximal interface is equipped with a high-voltage connector. 22. Amplifier assembly according to clause 21, wherein the high-voltage connector is in fluid communication with the proximal chamber. 23. Amplifier assembly of Clause 21, wherein the high-voltage connector is configured to accept high-pressure fluid. 24. An amplifier assembly of Clause 21, wherein the high-voltage connector is configured to accept pulses of high-pressure fluid. 25. An amplifier assembly of any of the clauses 23 to 24, wherein the high-pressure fluid is a gas. 26. An amplifier assembly according to any of the clauses 23 to 25, wherein the high-pressure fluid is air. 27. An amplifier assembly according to any of the clauses 21 to 26, wherein the high-voltage connector is made of metal. 28. The amplifier assembly of clause 27, in which the metal of the high-voltage connector is molded into the plastic of the proximal interface. 29. An amplifier assembly according to any of the clauses 21 to 28, wherein the high-voltage connector has an O-ring groove configured to accept an O-ring. 30. The amplifier assembly according to Clause 29, wherein the high-voltage connector comprises an O-ring disposed in an O-ring groove. 31. An amplifier assembly of any of the preceding clauses, wherein the proximal interface has a keyed surface. 32. An amplifier assembly according to Clause 31, wherein the keyed surface comprises one or more of the following: a grooved retaining element, an asymmetrical channel, an elongated shape, and a rectangular prism. 33. An amplifier assembly of any of the preceding clauses, further comprising an electrical assembly integrated into one or more of the proximal nose, distal waveguide, and diaphragm. 34. An amplifier assembly according to clause 33, wherein the electrical assembly comprises multiple electrical connectors integrated into the proximal interface. 35. An amplifier assembly according to any of the clauses 33 to 34, wherein the proximal interface is configured such that the electrical connector makes an electrical connection perpendicular to the long axis of the amplifier assembly. 36. An amplifier assembly according to any of the clauses 33 to 35, comprising multiple plates configured to interface with multiple ball connectors. 37. An amplifier assembly according to any of the clauses 33 to 36, wherein the electrical connectors include a ground plate that extends along the entire length of multiple electrical connectors. 38. An amplifier assembly according to any of the clauses 33 to 37, wherein the electrical assembly comprises a circuit. 39. An amplifier assembly according to any of the clauses 33 to 38, wherein the electrical assembly includes memory. 40. An amplifier assembly according to Clause 39, wherein the memory comprises one or more of the position sensor readings and pressure sensor readings. 41. An amplifier assembly of any of the preceding clauses, wherein the distal waveguide has a catheter interface located in the distal region of the distal waveguide. 42. Amplifier assembly of Clause 41, with a catheter interface in fluid communication with the distal chamber. 43. An amplifier assembly of any of the clauses 41 to 42, wherein the catheter interface is equipped with a Luer lock. 44. An amplifier assembly of Clause 43, wherein the Luer lock is a floating Luer lock. 45. An amplifier assembly of any of the clauses 41 to 44, wherein the catheter interface is configured to accept high-pressure fluid. 46. ​​An amplifier assembly of any of the clauses 41 to 45, wherein the catheter interface is configured to accept pulses of high-pressure fluid. 47. Amplifier assembly of Clause 46, wherein the high-pressure fluid is physiological saline. 48. An amplifier assembly of any of the preceding clauses, further comprising a pin configured to compress and hold the distal waveguide relative to the diaphragm and proximal nose. 49. Amplifier assembly of Clause 48, where the pins are steel pins. 50. An amplifier assembly of any of the preceding clauses, further comprising a pressure sensor configured to sense fluid pressure in a distal waveguide. 51. Amplifier assembly of Clause 50, in which a pressure sensor is integrated into the distal waveguide. 52. An amplifier assembly according to any of the clauses 50 to 51, wherein a pressure sensor is configured to sense the pressure in the distal chamber. 53. An amplifier assembly of any of the clauses 50 to 52, in which a pressure sensor is electrically connected to an electrical assembly. 54. An amplifier assembly of any of the preceding clauses, further comprising a sensor configured to sense the position of a diaphragm. 55. An amplifier assembly of Clause 54, wherein the sensor is a Hall sensor. 56. The sensor, A first magnet integrated into the proximal nose, A second magnet integrated into the distal waveguide at a specified distance from the first magnet, An amplifier assembly according to any of the clauses 54 to 55, comprising an electrical probe located in the central region of the diaphragm. 57. An amplifier assembly according to clause 56, wherein the proximal nose comprises a first receptacle configured to hold a first magnet in a fixed position. 58. An amplifier assembly of any of the preceding clauses, wherein the distal waveguide comprises a second receptacle for holding a second magnet in a fixed position. 59. Amplifier assembly of Clause 58, wherein the first and second receptacles are equipped with crush ribs. 60. An amplifier assembly of any of the clauses 56 to 59, in which an electrical probe is electrically connected to an electrical assembly. 61. An amplifier assembly of any of the preceding clauses, further comprising a magnet integrated into the central region of the diaphragm. 62. An amplifier assembly of any of the preceding clauses, further comprising a housing, wherein the proximal nose, distal waveguide, and diaphragm are located within the housing. 63. An amplifier assembly according to Clause 62, comprising one or more snap-fit ​​shells configured such that the housing substantially surrounds a proximal nose, a distal waveguide, and a diaphragm. 64. An amplifier assembly according to any of the clauses 61 to 63, wherein the housing comprises one or more flexible arms for interface with a handle assembly. 65. An amplifier assembly according to Clause 64, wherein one or more flexible arms are configured to hold the proximal interface of the proximal nose in place relative to the handle assembly. 66. An amplifier assembly according to any of the clauses 64 to 65, wherein one or more flexible arms are configured to provide haptic feedback for interface with the handle assembly. 67. An amplifier assembly according to any of the clauses 62 to 66, wherein the housing comprises one or more grooved portions configured for gripping the amplifier assembly by hand. 68. A handle assembly for controllably transmitting energy, A coupler assembly operably connected to an energy source, A manifold configured to be operably connected to an energy source via a coupler assembly and to controllably transmit energy to a distal interface, A handle assembly comprising a distal interface operably connected to the output of a manifold and configured to transmit energy received from the manifold. 69. A handle assembly of Clause 68, the manifold comprising an oscillator operably connected to an energy source. 70. A handle assembly of Clause 69, wherein the oscillator is configured to transmit energy through a manifold in a first position and discharge energy in a second position. 71. A handle assembly of any of the clauses 69 to 70, in which the oscillator is a solenoid. 72. A handle assembly according to any of the clauses 68 to 71, wherein the coupler assembly comprises an input coupler and an exhaust coupler, the input coupler being operably connected to an energy source and the exhaust coupler being configured to discharge energy from the energy source. 73. A handle assembly according to any of the clauses 68 to 72, wherein the coupler assembly comprises a tube. 74. A handle assembly of Clause 73, wherein the coupler assembly comprises an input tube and an output tube. 75. A handle assembly according to Clause 74, wherein the input tube is operably connected to an energy source and the discharge tube is configured to discharge energy from the energy source. 76. A handle assembly of any of the clauses 68 to 75, wherein the manifold is operably connected to an energy source via the input coupler of the coupler assembly. 77. A handle assembly according to any of the clauses 68 to 76, further comprising an electrical assembly electrically connected to a portion of the manifold. 78. A handle assembly of Clause 77, in which the electrical assembly is configured to control the oscillator. 79. A handle assembly of Clause 78, wherein the electrical assembly is configured to move the oscillator from a first position to a second position. 80. A handle assembly of any of the clauses 77 to 79, in which the electrical assembly is configured to interface with an external component. 81. A handle assembly of any of the clauses 77 to 80, wherein the electrical assembly is configured to accept input from an external component. 82. A handle assembly of any of the clauses 77 to 81, in which the electrical assembly is electrically connected to multiple pin connectors. 83. A handle assembly according to any of the clauses 68 to 82, wherein the handle is configured to be held by an operator. 84. A handle assembly of Clause 83, wherein the handle is configured to be held by an operator during use. 85. A handle assembly from any of clauses 68 through 84, with a handle weight of 0.5 lbs to 2.5 lbs. 86. A handle assembly according to any of the clauses 68 to 85, wherein the handle has a circumference of 1.5 inches to 5.0 inches. 87. A handle assembly of any of the clauses 68 to 86, with a handle having a length of 4.0 inches to 8.0 inches. 88. A handle assembly according to any of the clauses 68 to 87, wherein the handle has one or more tactile structures. 89. A handle assembly of Clause 88, wherein the tactile structure comprises a groove or a recess. 90. A handle assembly from any of the clauses 68 to 89, further comprising a housing, with the manifold located within the housing. 91. A handle assembly according to any of the clauses 68 to 90, further comprising an operator control unit. 92. A handle assembly according to Clause 91, wherein the operator control unit is equipped with buttons. 93. A handle assembly according to any of the clauses 91 to 92, wherein the operator control unit is configured to actuate the oscillator. 94. A handle assembly according to any of the clauses 91 to 93, wherein the operator control unit comprises an output element. 95. A handle assembly according to Clause 94, wherein the output element indicates the handle state. 96. A handle assembly of any of the clauses 94 to 95, wherein the output element comprises one or more lights. 97. A handle assembly according to any of the clauses 94 to 96, in which the output element is integrated into a button. 98. A handle assembly configured to perform a system self-check, as specified in any of clauses 68 through 97. 99. The handle assembly of Clause 98, in which a system self-check is performed before the oscillator is activated. 100. A system self-check that detects leaks from the energy source, as specified in any of clauses 98 to 99 of the handle assembly. 101. A handle assembly in any of the clauses 98 to 100, in which a system self-check detects leakage from an energy source in one or more external components to which the handle is operably connected. 102. A system self-check evaluates whether an amplifier assembly is operably connected to a handle assembly according to any of the clauses 1 through 67, or any of the handle assemblies according to any of the clauses 98 through 101. 103. A system self-check evaluates whether an amplifier assembly operably connected to a handle assembly according to any of clauses 1 to 67 functions as specified in any of clauses 98 to 102. 104. A system self-check evaluates whether the amplifier assembly functions as specified in any of the clauses 1 through 67, or any of the handle assemblies in any of the clauses 98 through 103. 105. A handle assembly according to any of clauses 98 to 104, in which a system self-check evaluates whether the diaphragm of the amplifier assembly is displaced in connection with the transfer of energy from the handle assembly to the amplifier assembly according to any of clauses 1 to 67. 106. A handle assembly according to clause 105, wherein the diaphragm is displaced by a specified amount. 107. A handle assembly according to any of the clauses 68 to 106, wherein the distal interface comprises one or more alignment structures. 108. A handle assembly according to Clause 107, wherein the alignment structure includes a keyed projection. 109. A handle assembly from any of the clauses 68 to 108, wherein the distal interface is configured to interface operably with an external component. 110. A handle assembly from any of the clauses 68 to 109, configured to interface operably with any amplifier assembly from any of the clauses 1 to 67. 111. A handle assembly from any of the clauses 68 to 110, wherein the handle assembly comprises one or more parts configured to interface operably with an amplifier assembly from any of the clauses 1 to 67. 112. Any handle assembly from any of the clauses 68 to 111, including a shape configured to be releasably coupled to any amplifier assembly from any of the clauses 1 to 67. 113. A handle assembly according to any of the clauses 68 to 112, wherein the handle assembly comprises one or more parts configured to operably connect to any of the amplifier assemblies according to any of the clauses 1 to 67. 114. A handle assembly comprising a fluid connection to an amplifier assembly of any of the provisions 68 to 113, wherein the handle assembly comprises a fluid connection to an amplifier assembly of any of the provisions 1 to 67. 115. A handle assembly from any of the clauses 68 to 114, wherein the handle assembly has an electrical connection to an amplifier assembly from any of the clauses 1 to 67. 116. A handle assembly having an interlock, as specified in any of clauses 68 to 115. 117. A handle assembly of Clause 116, wherein the interlock is configured to disable energy transfer if the handle assembly cannot detect the amplifier assembly. 118. Any handle assembly of clauses 116 to 117, wherein the interlock is configured to ensure that the amplifier is operably connected to the handle assembly. 119. A handle assembly of any of the clauses 116 to 118, wherein the interlock is configured to allow the handle assembly to transfer energy to the amplifier assembly when the amplifier assembly is operably connected to the handle assembly. 120. Any handle assembly of clauses 116 to 119, wherein the interlock is configured to prevent the handle assembly from transferring energy to the amplifier assembly when the amplifier assembly is not operably connected to the handle assembly. 121. A handle assembly of any of the clauses 68 to 120, wherein the distal interface is configured to interface operably with the proximal nose of the amplifier assembly. 122. A handle assembly of any of the clauses 68 to 121, wherein the distal interface alignment structure is configured to interface with the corresponding alignment structure of the proximal nose of the amplifier assembly. 123. A handle assembly of clause 122, wherein the alignment structure of the proximal nose of the amplifier assembly has a keyed surface. 124. Any handle assembly in any of the clauses 68 to 123, wherein the electrical assembly of the handle assembly is configured to be electrically connected to the electrical assembly of the amplifier assembly. 125. A handle assembly according to Clause 124, wherein the electrical assembly of the handle assembly is provided with multiple electrical connectors. 126. A handle assembly of Clause 125, wherein the electrical connector has multiple pins. 127. A handle assembly according to Clause 126, wherein the electrical assembly of the handle assembly comprises 2 to 25 pins. 128. A handle assembly of any of the clauses 126 to 127, in which multiple pins electrically connect to multiple plates of the electrical assembly of the amplifier assembly. 129. A handle assembly of any of the clauses 126 to 128, wherein multiple pins are located on the handle assembly. 130. A handle assembly according to any of the clauses 126 to 129, comprising multiple pins arranged in a V-shape. 131. A handle assembly of Clause 130, wherein the pins at the vertices of a V-shaped arrangement of multiple pins are electrically connected to ground. 132. A handle assembly of any of the clauses 128 to 131, wherein multiple pins and multiple plates are arranged such that the first electrical connection to ground is made when the amplifier assembly is operably connected to the handle assembly. 133. Any handle assembly of clauses 128 to 132, wherein multiple pins and multiple plates are arranged such that an electrical connection to ground is made before any other electrical connections are made when operably connecting the amplifier assembly to the handle assembly. 134. Any handle assembly of clauses 128 to 133, wherein multiple pins and multiple plates are arranged such that the electrical connection to ground is the last electrical connection to be disconnected when the amplifier assembly is disconnected from the handle assembly. 135. Any handle assembly of clauses 128 to 134, wherein multiple pins and multiple plates are arranged such that the electrical connection to ground is disconnected after other electrical connections are disconnected when the amplifier assembly is disconnected from the handle assembly. 136. A system for supplying pulsed energy, An amplifier assembly according to any of clauses 1 through 67, A system comprising a handle assembly from any of the clauses 68 to 135. 137. The system of Clause 136, further comprising a console assembly having an energy source operably connected to the handle assembly. 138. The system of Clause 137, wherein the console assembly further includes a regulator. 139. A system of any of the clauses 137 to 138 in which the energy source of the console assembly is a voltage potential, an electromagnetic potential, or a pressure potential. 140. Any system of clauses 137 to 139, wherein the console assembly comprises a regulator configured to adjust a first energy from an energy source to a second energy. 141. A system of Clause 140, wherein the regulator is an active regulator configured to be controlled by an electrical signal. 142. A system of Clause 141 in which the regulator is a passive regulator configured to be pre-set to a specific output. 143. The console assembly is It receives input from at least one of the console assembly, handle assembly, and amplifier assembly, Adjust the console assembly configuration based at least partially on the received input. A system further comprising a controller configured as described in any of the provisions of 137 to 142. 144. The system of Clause 143, wherein the controller is further configured to receive input from an input source located outside the system. 145. Any system of clauses 143 to 144, wherein the controller is configured to receive input from at least one of the following: electrocardiogram results, intravascular pressure monitor, blood volume monitor, or imaging system. 146. Any system of clauses 143 to 145, wherein the console assembly is the first console assembly, and the system comprises multiple operablely connected console assemblies. 147. A method for applying pulsed energy to tissue, The steps include deploying a pulsed balloon catheter system according to any of clauses 136 to 146 such that a tissue engagement element operably connected to the system is adjacent to the tissue, A method comprising the steps of engaging a system to energize an organization. 148. The method of Clause 147, wherein the tissue engagement element comprises a distal balloon. 149. Any method of clauses 147 to 148, wherein the tissue engagement element comprises a cardiac tissue compatibility element. 150. The tissue engagement element is operably connected to the output of the distal waveguide of the amplifier assembly of the system, in any manner described in any of the methods of Clauses 147 to 149. 151. A method according to any of the provisions 147 to 150, in which the method is to perform dynamic balloon angioplasty. 152. A method according to any of clauses 147 to 151, wherein the method is a method for evaluating vascular compliance. 153. A kit comprising any amplifier assembly from clauses 1 through 68. 154. A kit according to Clause 153, further comprising any handle assembly from Clauses 68 to 135. 155. A kit according to any of clauses 153 to 154, further comprising a console assembly according to any of clauses 137 to 146. 156. A kit in which one or more components are reusable, according to any of clauses 153 to 155. 157. The handle assembly is reusable, as per Clause 156 of the kit. 158. A kit in which one or more components are sterile, according to any of clauses 153 to 157. 159. A kit further comprising packaging as per any of clauses 153 to 158.

[0283] In at least some of the embodiments described above, one or more elements used in the embodiments may be interchangeably used in other embodiments unless such substitution is technically impractical. Those skilled in the art will understand that various other omissions, additions, and modifications may be made to the above methods and structures without departing from the scope of the claimed subject matter. All such modifications and changes are intended to fall within the scope of the subject matter as defined by the appended claims.

[0284] In general, the terms used herein, and in particular in the appended claims (e.g., the text of the appended claims), will be understood by those skilled in the art to be generally intended as “open” terms (for example, “including” should be interpreted as “including but not limited to,” “having” as “having at least,” and “includes” as “includes but not limited to,” and so on). Where a certain number of introduced claims are intended, such intention will be explicitly stated in the claims, and where there is no such statement, such intention will not be present, will be understood by those skilled in the art to be further understood. For example, to aid understanding, the following appended claims may include the use of the introductory phrases “at least one” and “one or more” to introduce the claims. However, the use of such phrases should not be interpreted as meaning that the introduction of a claim description by the indefinite article "a" or "an" limits any particular claim containing such introduced claim description to only one embodiment containing such description, even if the same claim contains the introduction phrase "one or more" or "at least one" and an indefinite article such as "a" or "an" (for example, "a" and / or "an" should be interpreted as meaning "at least one" or "one or more"). The same applies to the use of definite articles used to introduce claim descriptions. Furthermore, even if a particular number of introduced claim descriptions is explicitly stated, a person skilled in the art will recognize that such a statement should be interpreted as meaning at least the number stated (for example, the mere statement "two descriptions" without other modifiers means at least two descriptions or two or more descriptions).Furthermore, when a convention similar to "at least one of A, B, and C" is used, it is generally intended to be constructed in a way that a person skilled in the art would understand the convention (for example, "a system having at least one of A, B, and C" includes, but is not limited to, a system having only A, a system having only B, a system having only C, a system having both A and B, a system having both A and C, a system having both B and C, and / or a system having both A, B, and C). It will be further understood by those skilled in the art that substantially any disjunctive word and / or phrase presenting two or more alternative terms should be understood as construing the possibility of including one of the terms, either of the terms, or both of the terms, whether in the specification, claims, or drawings. For example, the phrase “A or B” is understood to include the possibilities of “A” or “B” or “A and B.”

[0285] Furthermore, where any feature or aspect of the present disclosure is described in relation to the Markush group, a person skilled in the art will recognize that the present disclosure also describes any individual member or subgroup of a member of the Markush group.

[0286] As will be understood by those skilled in the art, for any and all purposes, for providing, for example, written explanations, all scopes disclosed herein also encompass any and all possible subscopes and combinations thereof. Any enumerated scope can be readily recognized as sufficiently explainable and enable the division of the same scope into at least equal halves, thirds, quarters, fifths, tenths, etc. As a non-limiting example, each scope described herein can be readily decomposed into a lower third, a middle third, an upper third, etc. Also, as will be understood by those skilled in the art, all language such as “up to,” “at least,” “greater than,” and “less than” includes the enumerated numbers and refers to scopes that can be decomposed into subscopes as described above. Finally, as will be understood by those skilled in the art, a scope includes each individual member. Thus, for example, a group having 1 to 3 articles refers to a group having 1, 2, or 3 articles. Similarly, a group having 1 to 5 articles refers to a group having 1, 2, 3, 4, or 5 articles, and so on.

[0287] While the invention described above is illustrated and illustrated in some detail for clarity, it will be readily apparent to those skilled in the art that certain changes and modifications may be made in light of the teachings of the present invention without departing from the spirit or scope of the appended claims.

[0288] Therefore, the above merely illustrates the principles of the present invention. Those skilled in the art will understand that various configurations embodying the principles of the present invention and falling within its spirit and scope can be devised, even if not expressly described or shown herein. Furthermore, all examples and conditional statements enumerated herein are intended primarily to help the reader understand the principles of the present invention and the concepts to which the inventors have contributed to advancing the art, and should be construed as not being limited to such specifically enumerated examples and conditions. Moreover, all descriptions herein enumerating the principles, aspects, and embodiments of the present invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents. In addition, such equivalents are intended to include both currently known equivalents and equivalents to be developed in the future, i.e., any developed elements that perform the same function regardless of their structure. Furthermore, nothing disclosed herein is intended to be made available to the public, whether such disclosure is expressly stated in the claims or not.

[0289] Accordingly, the scope of the present invention is not intended to be limited to the exemplary embodiments illustrated and described herein. Rather, the scope and spirit of the present invention are embodied in the appended claims. In the claims, § 112(f) or § 112(6) of the U.S. Patent Act is expressly defined as being invoked for limitation in the claims only if the exact wording “means for” or the exact wording “step for” is placed at the beginning of such limitation in the claims. Where such exact wording is not used in limitation of the claims, § 112(f) or § 112(6) of the U.S. Patent Act is not invoked.

Claims

1. A proximal nose with a distal surface, A distal waveguide having a proximal surface, The system includes a diaphragm that seals between the proximal nose and the distal waveguide, separating the proximal chamber from the distal chamber, The diaphragm, The distal surface of the proximal nose and the proximal surface of the distal waveguide are translated, The diaphragm fits the distal surface of the proximal nose at its proximal position, At the distal position of the diaphragm, it fits the proximal surface of the distal waveguide. An amplifier assembly configured in such a way.

2. The amplifier assembly according to claim 1, wherein the diaphragm has a shape that fits the distal surface of the proximal nose at a proximal position of the diaphragm and fits the proximal surface of the distal waveguide at a distal position of the diaphragm.

3. The amplifier assembly according to any one of claims 1 to 2, wherein the diaphragm comprises one or more of the following: folding, pleating, and pleated bellows.

4. The amplifier assembly according to any one of claims 1 to 3, wherein the distal waveguide is configured to generate a smooth fluid flow from the diaphragm to the distal region of the distal waveguide.

5. The amplifier assembly according to any one of claims 1 to 4, wherein the distal waveguide has a shape configured to reduce turbulence in the fluid flow from the diaphragm to the distal region of the distal waveguide.

6. The amplifier assembly according to any one of claims 1 to 5, wherein the distal waveguide has a funnel-shaped geometric form.

7. The amplifier assembly according to any one of claims 1 to 6, wherein the proximal nose comprises a proximal interface located in the proximal region of the proximal nose.

8. The amplifier assembly according to claim 7, wherein the proximal interface comprises a high-voltage connector.

9. The amplifier assembly according to any one of claims 1 to 8, further comprising an electrical assembly integrated into one or more of the proximal nose, the distal waveguide, and the diaphragm.

10. The amplifier assembly according to any one of claims 1 to 9, further comprising a pressure sensor configured to sense the fluid pressure in the distal waveguide.

11. The amplifier assembly according to claim 10, wherein the pressure sensor is integrated with the distal waveguide.

12. The amplifier assembly according to any one of claims 1 to 11, further comprising a sensor configured to sense the position of the diaphragm.

13. The amplifier assembly according to claim 12, wherein the sensor is a Hall sensor.

14. The amplifier assembly according to any one of claims 1 to 13, further comprising a balloon catheter operably connected to the distal waveguide.

15. The amplifier assembly according to claim 14, wherein the amplifier assembly is operably connected to an energy source.

16. The amplifier assembly according to claim 15, wherein the energy source comprises a pulse generator.

17. A system comprising an energy source operably coupled to the amplifier assembly according to claim 14.

18. The system according to claim 17, wherein the energy source comprises a pulse generator.

19. The system according to claim 18, wherein the pulse generator comprises a console and a handle.

20. A method comprising the step of operably connecting the amplifier assembly according to claim 14 to an energy source.

21. The method according to claim 17, wherein the energy source comprises a pulse generator.

22. The method according to any one of claims 17 to 18, further comprising the step of positioning the balloon of the balloon catheter adjacent to the tissue.

23. The method according to claim 19, further comprising the step of providing energy to the tissue.

Images