Manifold system for applying pulsatile intravascular lithotripsy, device and method thereof

Abstract

Disclosed herein are systems, devices, and methods for treating diseased blood vessels through the use of pulsatile endovascular lithotripsy. In particular, an amplifier assembly is provided; a handle assembly for controllably delivering potential energy is also provided; a system for applying pulsatile energy is provided, where such system includes the amplifier assembly and the handle assembly; and a method for applying pulsatile energy to tissue is provided.

Description

Cross-references to related applications

[0001] Pursuant to 35 USC §119(e), this application claims priority to U.S. Provisional Patent Application Serial No. 63 / 545,060, filed October 20, 2023, the disclosure of which is incorporated herein by reference in its entirety. Background Technology

[0002] Ischemic heart disease is the leading cause of death worldwide, caused by the buildup of atherosclerotic plaques in the blood vessels of the body. Globally, these diseases account for 84.5% of cardiovascular deaths and 28.2% of all deaths. Ischemic heart disease develops through a mechanism called atherosclerosis, which is the accumulation of fatty and calcified material that leads to narrowing of the arterial lumen. Both the coronary and peripheral arteries can suffer from atherosclerotic plaque buildup. The plaque buildup caused by atherosclerosis restricts blood flow through these arteries and can lead to major 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 as the disease progresses, these plaques physically harden or calcify. Calcified plaques (CPs), or lesions, most commonly occur in the innermost layer of the arterial wall. These CPs are caused by the deposition and remodeling of calcium hydroxyapatite, a process that mimics bone formation. Blood vessels burdened with CPs have reduced vascular elasticity and impaired vascular perfusion. Due to this reduced compliance and perfusion, CP is associated with an increased risk of death and other adverse events.

[0003] While many patients with plaque-loaded vessels (CP) are asymptomatic, a significant proportion develop ischemia-related symptoms and signs and undergo endovascular or surgical repair. Given its lower incidence, endovascular approaches are generally preferred. However, CP-loaded vessels present unique challenges for effective endovascular treatment. A series of devices are typically used to treat CP-loaded vessels. Pre-dilation of the CP lesion is first performed using balloon angioplasty (BA). During BA, a balloon is advanced into the affected artery and dilates it to widen the plaque-loaded vessel, thereby restoring normal blood flow. This pre-dilation step must be successful before successful use of adjunctive therapies such as drug-eluting balloons or stents. For successful pre-dilation, BA must mechanically rupture the CP to ensure long-term patency and restore the elasticity of the surrounding healthy vessels. High-pressure, non-compliant balloons are often used to achieve success. However, due to the strength of the CP, complete balloon dilation is often limited, and the CP remains undisturbed. Insufficient balloon dilation and CP rupture leave residual stenosis in the vessel, restricting downstream blood flow, indicating a high risk of poor outcomes, immediate or long-term failure, and the need for additional surgery. To ensure the patency of the diseased blood vessel, the high rupture strength of the CP must be overcome.

[0004] In standard BA procedures, a pressure-bearing catheter balloon is used to break up atherosclerotic plaques and expand them into the arterial wall to restore normal blood flow in the narrowed artery. Typically, the balloon is inflated via a manually driven screw-driven syringe, which converts rotation of the handle facing the physician into displacement of the syringe piston. The clinician rotates the syringe handle until the pressure within the system reaches the desired level, or the physician feels the calcified plaque break up. During treatment, the physician can sense whether the calcified plaque has broken up in two ways: (1) by fluoroscopic visualization of the balloon's outline, a medical imaging technique commonly used in cardiovascular surgery, and (2) by a decrease in pressure within the hydraulic system indicated by a pressure gauge. During angioplasty, a radiopaque dye (i.e., a contrast agent) is introduced into the balloon, which, under fluoroscopy, illuminates the outline of the balloon and the arterial wall. When the plaque is intact and the balloon is inflated, the balloon exhibits a characteristic "dog bone" shape, where the proximal and distal edges expand unrestricted, but the central portion is blocked by the plaque. The shape of the "dog bone" informs the clinician about the severity and distribution of the plaque. A more uniformly expanding balloon indicates to the physician that the plaque has been treated. A second method for sensing plaque rupture is indicated by a pressure gauge attached to the balloon. When treating severe and / or circumferentially distributed plaques, the pressure in the balloon increases until the plaque ruptures. Before plaque ruptures, the balloon retains the previously described "dog bone" shape. After rupture, the plaque no longer restricts balloon expansion, and the balloon expands the plaque into an elastic artery. With this balloon expansion, the balloon's volume increases, transforming it from a "dog bone" shape into a fully expanded cylinder. This increase in volume causes a drop in pressure within the balloon, a change that can be seen or felt on the attached pressure gauge.

[0005] To overcome the rupture strength of CP (capillary vascular fragmentation), angioplasty balloons are typically used to aggressively dilate vessels loaded with CP. In these cases, the balloon is inflated beyond its rated burst pressure (i.e., >20–40 ATM) to achieve adequate arterial dilation. These aggressive procedures expose patients to increased risks, such as balloon rupture in 21% of cases, vessel dissection in 76% of cases, and restenosis (i.e., postoperative restenosis) in 20–30% of cases. Other treatment strategies attempting to break CP include cutting and scoring balloons (BA) and lithotripsy balloons (BA). Cutting balloons (balloons surrounded by sharp metal blades) and scoring balloons (balloons constrained by metal cages) are designed to create stress concentrations for CP rupture. Intravascular lithotripsy uses a low-pressure balloon with a lithotripter embedded within to generate shock waves. Another method commonly used to treat CP is rotary cutting, a technique that uses grinding to reduce the volume of CP. The risks of these treatments may include vessel dissection and perforation, damage to healthy tissue surrounding the lesion, and an increased risk of restenosis.

[0006] There remains a need for improved balloon angioplasty devices and methods of use, such as devices and systems for intravascular lithotripsy and their methods of use. Summary of the Invention

[0007] This document discloses systems, apparatus, and methods for treating diseased blood vessels using pulsatile intravascular lithotripsy. Specifically, an amplifier assembly is provided; a handle assembly for controllably delivering energy is provided; a system for applying pulsatile energy is provided, wherein such a system includes the amplifier assembly and the handle assembly; and a method for applying pulsatile energy to tissue using the components and systems of the present invention is also provided.

[0008] Aspects of the amplifier assembly include: a proximal nose including a distal face; a distal waveguide including a proximal face; and a diaphragm sealing 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 an embodiment, the diaphragm is configured to translate between the distal face of the proximal nose and the proximal face of the distal waveguide. In an embodiment, the diaphragm is configured to translate between the distal face of the proximal nose and the proximal face of the distal waveguide without inducing strain on the diaphragm.

[0009] Aspects of the handle assembly for controllably transferring energy include: a connector assembly operably connected to an energy source; a manifold operably connected to the energy source via the connector assembly and configured to controllably transfer energy to a remote interface; and a remote interface operably connected to the output of the manifold and configured to transfer energy received from the manifold.

[0010] According to the present invention, the system for applying pulsating energy includes an amplifier assembly and a handle assembly.

[0011] Methods for applying pulsating energy to tissues utilize the components and / or systems disclosed herein.

[0012] In addition, kits are provided that include components such as the amplifier assembly, handle assembly, and / or system described herein.

[0013] The components, systems, methods, and kits can be used in a variety of different applications, including balloon angioplasty applications. Attached Figure Description

[0014] The invention can be best understood from the following detailed description when read in conjunction with the accompanying drawings. The drawings include the following illustrations:

[0015] Figure 1AA system according to an embodiment of the invention is described, having an amplifier assembly connected to a handle assembly, both of which are according to an embodiment of the invention; Figure 1B An isometric view of an amplifier assembly according to an embodiment of the present invention is depicted; Figure 1C A view of an amplifier assembly and a handle assembly according to an embodiment of the present invention is depicted.

[0016] Figure 2A-2B An amplifier assembly according to an embodiment of the present invention is described. Figure 2A An internal view of an amplifier assembly according to an embodiment of the present invention is depicted. Figure 2B An embodiment of an amplifier assembly is depicted, wherein a clamp is used to securely hold the diaphragm in a sealed position.

[0017] Figures 3A-3B A schematic diagram of the proximal nose of an amplifier assembly according to an embodiment of the present invention is depicted.

[0018] Figures 4A-4B A schematic diagram of the distal waveguide of an amplifier assembly according to an embodiment of the present invention is depicted.

[0019] Figures 5A-5C A schematic diagram of the diaphragm of an amplifier assembly according to an embodiment of the present invention is depicted.

[0020] Figures 6A-6C A schematic diagram of the housing of an amplifier assembly according to an embodiment of the present invention is depicted.

[0021] Figures 7A-7B Exemplary steps for assembling an amplifier assembly embodiment are shown.

[0022] Figures 8A-8F Different views of aspects of the handle assembly according to embodiments of the present invention are depicted.

[0023] Figures 9A-9F Different views of aspects of the handle assembly according to embodiments of the present invention are depicted.

[0024] Figures 10A-10B An overview of embodiments of the control software functions of a system according to embodiments of the present invention is presented; Figure 10C An example graphical user interface for controlling and receiving information about a system according to an embodiment of the present invention is presented.

[0025] Figure 11 Aspects of a system according to embodiments of the present invention are described.

[0026] Figure 12 A system for applying pulsating energy according to an embodiment of the present invention is shown.

[0027] Figure 13 The proximal nose portion according to an embodiment of the present invention is depicted.

[0028] Figure 14 A remote waveguide according to an embodiment of the present invention is depicted.

[0029] Figures 15A-15B A diaphragm according to an embodiment of the present invention is depicted.

[0030] Figure 16 The proximal nose portion according to an embodiment of the present invention is depicted.

[0031] Figures 17A-17D An amplifier assembly according to an embodiment of the present invention is described.

[0032] In the accompanying drawings, unless otherwise expressly stated, elements with the same or similar reference numerals have the same or similar features. Detailed Implementation

[0033] A system for applying pulsating energy according to embodiments of the present invention, such as Figure 1A As shown. System 102 includes a control console 103, a carbon dioxide tank 104, an amplifier assembly 100, a handle assembly 101, a catheter assembly 105, and a distal balloon 107. Figure 1A In this design, amplifier assembly 100 and handle assembly 101 are depicted as operatively connected; however, amplifier assembly 100 and handle assembly 101 are configured to be detachable from each other. For example, in some cases, handle assembly 101 is reusable while amplifier assembly 100 is disposable, allowing handle assembly 101 and amplifier assembly 100 to be detached so that handle assembly 101 can be operatively connected to another amplifier assembly.

[0034] Figure 1A The system 102 in use is shown. An amplifier assembly 100 is operatively connected to a catheter assembly 105 at its relatively distal end. The catheter assembly 105 includes a tissue engagement element in a relatively distal region. The tissue engagement element of the catheter assembly 105 includes a distal balloon 107, i.e., a balloon configured to receive pressure pulses removed from the amplifier assembly 100.

[0035] Handle assembly 101 is operably connected to console 103 on its proximal side. Console 103 receives energy in the form of pressurized carbon dioxide from carbon dioxide tank 104 and transmits this energy to handle assembly 101. For ease of use, console 103 is mounted on IV lever 106.

[0036] As described herein, the handle assembly 101 of system 102 is configured to receive energy from a pressure source (i.e., carbon dioxide canister 104 and console 103) and transmit this energy to amplifier 100. Amplifier assembly 100 of system 102 is configured to convert the energy received from handle 101 and ultimately from the pressure source (i.e., carbon dioxide canister 104 and console 103) into energy that is transmitted to catheter assembly 105 and ultimately to tissue bonding element (e.g., its distal balloon 107) for repeated pressurization and inflation of such balloon 107. This repeated pressurization and inflation of the distal balloon 107 enables safe and controlled fatigue fracture of CP lesions.

[0037] Amplifier components are provided. (See reference) Figure 2A The amplifier assembly includes: a proximal nose 210 including a distal facet 211; a distal waveguide 260 including a proximal facet 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 an embodiment, the diaphragm 270 is configured to translate between the distal facet 211 of the proximal nose 210 and the proximal facet 261 of the distal waveguide 260 without inducing strain on the diaphragm 270.

[0038] A handle assembly for controlled energy transfer is also provided. For example... Figures 8A-8F and Figures 9A-9C As best shown, aspects of the handle assembly include: a connector assembly 850 operatively connected to an energy source; a manifold 830 operatively connected to the energy source via the connector assembly 850 and configured to controllably deliver energy to a remote interface 810; and a remote interface 810 operatively connected to the output of the manifold 830 and configured to deliver energy received from the manifold 830. As described herein, the handle assembly 800 is operatively connected to the amplifier assembly 200 via the remote interface 810, for example, the handle assembly 800 is connected to the amplifier assembly 200 via a port 820. Figure 2A The connection between the high-voltage connectors 223 shown is operatively connected to the amplifier assembly 200.

[0039] Systems for applying pulsating energy are also provided, wherein such systems include an amplifier assembly and a handle assembly according to the invention. Methods for applying pulsating energy to tissue are also provided. Furthermore, kits comprising components including the amplifier assembly, handle assembly, and / or system described herein are provided. These components, systems, and kits can be used in a variety of different applications, including balloon angioplasty applications.

[0040] The systems, components, and apparatus of the present invention, which together or individually provide the integrated manifold system of embodiments of the invention, can be configured to provide or be operatively connected to one or more tissue-attaching elements, such as a distal balloon 107 or a cardiac tissue-attaching element, which apply pulsating energy to internal tissue in contact with it (e.g., luminal vascular tissue, such as the inner wall of an artery). The energy transmitted from amplifier assembly 200 to balloon 107 is applied to the internal tissue in contact with it in the form of increasing and decreasing pressures applied at a desired frequency and / or displacement, duty cycle, and amplitude. As used herein, frequency is the number of full pressure pulse cycles (peak-to-peak) per unit time; displacement is the total cyclic change in the volume and / or diameter of the balloon; duty cycle is the percentage of time allocated to the high-pressure segment in a single pressure cycle; amplitude is the difference between the maximum and minimum pressures. Because the energy applied by the balloon to the internal tissue is pulsating, it varies (e.g., increases and decreases) at a defined or determined frequency and duty cycle. During balloon angioplasty (BA) treatment, distal blood flow to the distal balloon may be obstructed, which may limit treatment time. For successful treatment to occur within this timeframe, the pulse frequency and amplitude must deliver sufficient energy to the tissue for treatment. While the frequency of the pulsating energy delivered by the balloon to its associated tissue can vary, in some cases the frequency is high, ranging from 0 to 100 Hz in some instances, such as 0 to 25 Hz. Similarly, the duty cycle of the pulsating energy delivered by the balloon to the tissue can vary, ranging from 10% to 100% in some instances, such as 60% to 80%. Variations in volume or balloon diameter depend on the patient's anatomy and / or the specific balloon size used in the procedure. The amplitude of the pulsating energy delivered by the balloon to the tissue can vary, ranging from 0 to 100 atmospheres (ATM) in some instances, such as 0 to 30 atmospheres during a given procedure, and the frequency can vary during the procedure, i.e., it is not kept constant as needed.

[0041] Pulsating energy, when exposed to diseased vascular tissue, can effectively treat diseased tissue, such as calcified plaques (CP), while reducing and / or eliminating adverse effects on surrounding healthy tissue. Key characteristics of the pulsating energy required for successful treatment include the frequency and amplitude of the delivered pulsating energy. In this embodiment, such pulsating energy enables safe and controlled fatigue fracture of calcified plaque lesions. Fatigue fracture is the process of cyclically loading a structure to pressures below those that cause the instantaneous fragmentation and / or crack propagation of CP lesions. Conventional treatments apply dangerously high-pressure pulses to the vessel, potentially causing dissection and perforation in surrounding healthy tissue, while pulsatile angioplasty uses low-pressure, high-frequency oscillations within a balloon to initiate low-pressure fatigue fracture of CP lesions.

[0042] Generating pulsatile intravascular lithotripsy energy in a catheterization lab or clinic requires a system that connects, monitors, and maintains various pressures with minimal or no fluid and / or gas leakage. Furthermore, the system and its components must be efficiently manufactured. Moreover, the system must be capable, reliable, and functionally sound for the end user.

[0043] Before describing the invention in more detail, it should be understood that the invention is not limited to the specific embodiments described, as such embodiments can certainly be varied. It should also be understood that the terminology used herein is for the purpose of describing specific embodiments only and is not intended to be limiting, as the scope of the invention is limited only by the appended claims.

[0044] Where a numerical range is provided, it should be understood that, unless the context explicitly specifies otherwise, every intermediate value between the upper and lower limits of the range (to one-tenth of the lower limit unit), as well as any other stated or intermediate value within the range, is included within the invention. The upper and lower limits of these smaller ranges may be independently included within the smaller range and also within the invention, subject to any explicitly excluded limitations within the range. Where the range includes one or both limitations, the range excluding any one or both of those included limitations is also included in the invention.

[0045] Certain ranges in this document are presented with the term "approximately" preceding the numerical value. The term "approximately" is used in this document to provide textual support for the exact number preceding it, as well as for numbers that are close to or approximate to the number preceding the term. In determining whether a number is close to or approximate to a particular enumerated number, the unenumerated number that is close to or approximate can be a number that provides a substantial equivalence to the particular enumerated number in its presented context.

[0046] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Although any methods and materials similar to or equivalent to those described herein may also be used in the practice or testing of this invention, representative illustrative methods and materials are described hereafter.

[0047] All publications and patents referenced in this specification are incorporated herein by reference as if each individual publication or patent were specifically and individually indicated to be incorporated by reference, and are incorporated herein by reference to disclose and describe the methods and / or materials relating to the referenced publications. Any reference to a publication refers to its disclosure prior to the filing date and should not be construed as an admission that the invention is not entitled to a prior art invention prior to such publication. Furthermore, the publication dates provided may differ from the actual publication dates and may require independent verification.

[0048] It should be noted that, as used herein and in the appended claims, an element without a defined number includes a plurality of that element unless the context clearly indicates otherwise. Further note that claims may be drafted to exclude any optional element. Therefore, this statement is intended as a premise for the use of exclusive terms such as "merely" or "only" in relation to the statement of a claim element, or for the use of a negative limitation.

[0049] As will be apparent to those skilled in the art upon reading this disclosure, each individual embodiment described and illustrated herein has discrete components and features that can be readily separated from or combined with features of any other several embodiments without departing from the scope or spirit of the invention. Any described methods may be performed in the order of the described events or in any other logically possible order.

[0050] While the apparatus and method and their functional interpretation have been or will be described for grammatical fluency purposes, it should be clearly understood that, unless expressly set forth in 35 USC §112, the claims should not be construed as necessarily being limited in any way to the construction of “means” or “steps”, but rather should be given the full scope of the definitions provided by the claims and their equivalents in accordance with the judicial principle of equivalents, and where the claims are expressly set forth in 35 USC §112, they should be given all legal equivalents in accordance with 35 USC §112.

[0051] In further describing various aspects of the invention, the amplifier assembly and its components are first described in more detail. Following this, the handle assembly and its components are described. Next, a system for applying pulsating energy, comprising the amplifier assembly and the handle assembly, is described. Following this, methods for using the amplifier assembly, the handle assembly, and the system, as well as kits for practicing the methods of the invention, are described.

[0052] Amplifier components

[0053] Aspects of the amplifier assembly include: a proximal nose including a distal face; a distal waveguide including a proximal face; and a diaphragm sealing 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 face of the proximal nose and the proximal face of the distal waveguide. In some embodiments, the diaphragm is configured to translate between the distal face of the proximal nose and the proximal face of the distal waveguide without inducing strain on the diaphragm.

[0054] For illustration, in an embodiment, the amplifier assembly may be configured to operatively connect a tissue bonding element, such as a distal balloon or cardiac tissue bonding element (i.e., a catheter operatively connected to a distal waveguide of the amplifier assembly), to an energy source, such as a pressure source (i.e., a handle assembly operatively connected to the amplifier assembly). In such embodiments, the amplifier assembly is configured to convert energy derived from, for example, such a pressure source into energy transmitted to such a catheter and tissue bonding element for applying energy (e.g., pressure) to, for example, a distal balloon or cardiac tissue bonding element present in a distal region of such a catheter; that is, repeatedly pressurizing and inflating aspects of such a balloon or cardiac tissue bonding element.

[0055] In one embodiment, the amplifier assembly includes a diaphragm sealed between a proximal nose and a distal waveguide. In another embodiment, the amplifier assembly includes a diaphragm compressed and held between the proximal nose and the distal waveguide. In another embodiment, the diaphragm separates a proximal chamber present in the proximal nose from a distal chamber present in the distal waveguide. In another embodiment, the proximal chamber is defined by a first volume between the diaphragm and the distal facet of the proximal nose. In another embodiment, the distal chamber is defined by a second volume between the diaphragm and the proximal facet of the distal waveguide.

[0056] The amplifier assembly according to the invention is configured to receive a first pulsating energy from an energy source (e.g., a potential energy source, such as a pulse generator), convert it into a second pulsating energy, which can propagate along the length of the amplifier assembly, for example, along its fluid (e.g., liquid) channels, and ultimately to, for example, a distal balloon or other tissue-attached element. When the amplifier assembly converts the first pulsating energy into the second pulsating energy, it changes the form of the pulsating energy in some way. Examples of energy form changes that can be made by the amplifier assembly include, but are not limited to: gas pressure and / or flow rate to liquid pressure and / or flow rate, mechanical potential energy and / or kinetic energy to fluid pressure and / or flow rate, optical potential energy and / or kinetic energy to fluid pressure and / or flow rate, electric potential energy and / or kinetic energy to fluid pressure and / or flow rate, magnetic potential energy and / or kinetic energy to fluid pressure and / or flow rate, etc. For example, when the first pulsating energy is pneumatic first pulsating energy, the amplifier assembly can be configured to convert the pneumatic first pulsating energy into a second hydraulic pulsating energy, which can propagate from the proximal end to the distal end of the amplifier assembly; this is a gas-to-liquid conversion of the pulsating energy. In some cases, the amplifier assembly propagates the second pulsating energy from the proximal end to the distal end with minimal attenuation (if any), wherein any amount of attenuation (if present) does not exceed a reduction of 30%, and in some cases, for example, does not exceed 5%.

[0057] Similarly, the amplifier assembly according to the invention is further configured to receive a first static energy from an energy source (e.g., a potential energy source) and convert it into a second static energy, which can propagate along the length of the amplifier assembly, for example, along its fluid (e.g., liquid) channels, and ultimately to the distal balloon. Static energy refers to, for example, the application of a first pressure, or the application of pneumatic energy sustained for a specified period of time. That is, the amplifier assembly can be configured to receive a first pressure applied to the amplifier assembly for a sustained specified period of time.

[0058] An amplifier assembly according to an embodiment of the invention is configured to be operatively connected to a handle assembly, the handle assembly ultimately including or being connected itself to an energy source for providing a first pulsating energy or a first static energy. The amplifier assembly can be operatively connected to the handle assembly using any of a variety of standard connectors known in the art to achieve a quick, reliable, and repeatable connection from 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-in connectors, Yor-lock connectors, claw clip connectors, gasket connectors, receptacle connectors, flange connectors, cam-slot receptacles, quick connectors, etc., wherein aligners or notches may be used as needed to provide a connection capable of repeatably and accurately positioning the amplifier assembly relative to the handle assembly and / or the electrical connector (i.e., the electrical connector of the handle assembly).

[0059] Amplifier assemblies can be configured as reusable or disposable as needed. In cases where the amplifier assembly (or aspects thereof) is reusable and may come into contact with patient areas, such assemblies can be configured to be covered in a disposable sterile sleeve or bag, allowing the amplifier assembly to be used without contaminating the sterile area of ​​the operating room.

[0060] diaphragm

[0061] As described above, the amplifier assembly of embodiments of the present invention includes 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 embodiments of the present invention includes a diaphragm compressed between the proximal nose and the distal waveguide to seal the proximal chamber from the distal chamber. In embodiments, 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 facet of the proximal nose is substantially opposite the proximal facet of the distal waveguide. In embodiments, the proximal chamber is defined by a first volume between the diaphragm and the distal facet of the proximal nose. In embodiments, the distal chamber is defined by a second volume between the diaphragm and the proximal facet of the distal waveguide. The diaphragm is configured to translate between the distal facet of the proximal nose and the proximal facet of the distal waveguide. As described herein, the diaphragm is configured to translate in such a way that strain is introduced on the diaphragm.

[0062] As described above, the diaphragm can be sealed between the proximal nose and the distal waveguide, separating the proximal and distal chambers. In some cases, the diaphragm can be compressed between the proximal nose and the distal waveguide, thereby sealing the proximal and distal chambers. In embodiments, the diaphragm may include an outer ring or retaining feature configured to seal the interface between the proximal nose and the distal waveguide. In some cases, this outer ring or retaining feature is an O-ring, such as a polymer O-ring, attached to or molded onto the diaphragm. In other embodiments, this interface can be sealed using clips.

[0063] In other embodiments, the diaphragm includes an outer ring or retaining feature, which is a circumferential protrusion attached to or molded onto the diaphragm and, as described above, configured to maintain its seal when the diaphragm translates between the distal face of the proximal nose and the proximal face of the distal waveguide. That is, the diaphragm may include a circumferential protrusion shaped such that, when the diaphragm translates in a proximal or distal direction, the protrusion reinforces the diaphragm seal, for example, on the side opposite to the direction of translation. In some cases, the circumferential protrusion is a T-shaped edge or a wedge shape.

[0064] In embodiments, the outer ring or retaining feature or circumferential protrusion may be separable from or co-molded with the rest of the diaphragm. This outer ring or retaining feature or circumferential protrusion can have any convenient geometry as needed, such as a circumferential protrusion located at an external position on the diaphragm that is substantially T-shaped, circular, or wedge-shaped, or has a cross-sectional geometry sufficient to withstand mechanical, pneumatic, or hydraulic stresses, such as a gasket or annular seal for mechanical retention. In embodiments, the outer ring or retaining feature or circumferential protrusion is shaped to fit corresponding grooves in the proximal nose and distal waveguide. Each of these grooves may include a lip that compresses a relatively soft diaphragm material. The interaction between the groove and the outer ring or retaining feature or circumferential protrusion of the diaphragm creates both an axial seal and a radial support region to prevent the diaphragm from being pulled out during pulses (i.e., translation of the diaphragm in the proximal and distal directions).

[0065] To further reduce pull-out forces during pulses, the diaphragm can be configured to translate between the distal face of the proximal nose and the proximal face of the distal waveguide without inducing strain on the diaphragm. For example, in an embodiment, to further reduce pull-out forces during pulses, additional material can be incorporated into the diaphragm to enable axial movement (i.e., translation in both the distal and proximal directions) without generating significant pull-out forces at the sealing edges of the diaphragm (e.g., the outer periphery of the diaphragm). As described herein, this additional material can be incorporated into the diaphragm via an accordion-shaped bellows, such that the bending and folding of the bellows provides material to the center of the diaphragm for translation without significantly increasing radial forces, for example, on the outside of the diaphragm. That is, the diaphragm is configured to translate between the distal face of the proximal nose and the proximal face of the distal waveguide without generating significant strain on the diaphragm. Due to this reduction in radial stress, the force pulling the diaphragm at the diaphragm edges (i.e., the outer periphery) is reduced, thereby mitigating leakage (e.g., disruption of the seal of the proximal or distal chamber) or pull-out.

[0066] It is conceivable that some embodiments utilize diaphragms configured to translate proximal and distally without inducing strain on the diaphragm, such as diaphragms with additional material (e.g., folds or bellows) acting as movable hinges. The diaphragm shape can be generated, for example, by mass production techniques, or created by stamping, molding, or hot stamping. Residual stress can be incorporated into the diaphragm design such that when the diaphragm is axially translated due to an incoming pressure pulse, it is stretched to a specified desired degree, causing, for example, the diaphragm to return to its initial state, such as a neutral or central position. This residual stress in the diaphragm forces 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.

[0067] Furthermore, configuring the diaphragm to translate proximally and distally without inducing strain on the diaphragm (e.g., using a bellows-like construction) allows the diaphragm to expand continuously to meet the volume requirements of, for example, an expanding distal balloon operatively connected to an amplifier assembly, which receives fluid, for example, removed from the distal chamber by the diaphragm. In embodiments, the diaphragm is configured with a movable hinge (i.e., the diaphragm is configured to translate proximally and distally without inducing strain or substantial strain on the diaphragm), operating within the low elasticity range of the diaphragm material, rather than utilizing a flat plate as the diaphragm, in which case relatively significant radial stress would be applied to the diaphragm wall. In embodiments, the diaphragm materials are selected such that they operate within the low elasticity range when formed into the desired diaphragm configuration. This configuration of the diaphragm in the present invention increases the reliability of the diaphragm when exposed to high-pressure fluids.

[0068] As described above, in this embodiment, the diaphragm is configured to occupy different positions between the distal face of the proximal nose and the proximal face of the distal waveguide. In this embodiment, the diaphragm is further configured to translate between the different positions without inducing strain on the diaphragm material. As the diaphragm translates back and forth between the distal face of the proximal nose and the proximal face of the distal waveguide, the diaphragm can take on different shapes to accommodate the different positions; for example, it can unfold itself, allowing additional diaphragm material to be used to accommodate the different positions without inducing strain on the diaphragm. The diaphragm can be configured such that at the proximal position, it can conform to (i.e., cover or flatten) the distal face of the proximal nose, and at the distal position, it conforms to the proximal face of the distal waveguide. In this embodiment, the diaphragm includes a shape that conforms to the distal face of the proximal nose at the proximal position and conforms to the proximal face of the distal waveguide at the distal position. For example, in some cases, the diaphragm includes folds, corrugations, or corrugated bellows. In other words, the diaphragm can be shaped or otherwise configured such that additional material becomes available (i.e., unfolded) when the diaphragm extends to a relatively proximal or distal position. This diaphragm can be further configured such that this additional material refolds back onto itself when the diaphragm returns to a relatively neutral position.

[0069] In some embodiments, the diaphragm includes a shape that, when substantially fully extended, adapts to a recess within the distal facet of the proximal nose and a recess within the proximal facet of the distal waveguide. For example, the diaphragm may include folds on the diaphragm such that additional material unfolds into a corresponding bend or other shape in the distal facet of the proximal nose or the proximal facet of the distal waveguide, in each case configured to receive this additional material of the diaphragm. That is, the linear length of the diaphragm is configured such that, in its extended position (whether proximal or distal), it conforms to the surface of the distal facet of the proximal nose or the proximal facet of the distal waveguide, resulting in minimal unused space or trapped gas that would otherwise lead to a reduction in maximum pulse delivery efficiency.

[0070] As described above, the diaphragm is configured to translate between the distal face of the proximal nose and the proximal face of the distal waveguide without generating strain on the diaphragm. "Without generating strain on the diaphragm" means, for example, that no tension is generated on the diaphragm, no stretching of the diaphragm material, no resistance from the diaphragm material, and no stress is applied to the diaphragm material. In the embodiments, "without generating strain on the diaphragm" means that no substantial or material, significant, undesirable, or unexpected strain is generated on the diaphragm, for example, strain sufficient to cause leakage or pull-out of the diaphragm from its location between the proximal nose and the distal waveguide.

[0071] As described above, the diaphragm separates the proximal and distal chambers and is configured to translate in response to a first pulsating energy, thereby generating a second pulsating energy in the distal chamber of the amplifier assembly. The size of the diaphragm can vary, with some cases having an area ranging from 100 mm² to 5000 mm², for example, 500 mm² to 2000 mm², or 400 mm² to 800 mm². The diameter of the diaphragm in its fully neutral or folded state can vary, with some cases having a diameter in its folded state ranging from 10 mm² to 75 mm, for example, 20 mm² to 50 mm, or 10 mm² to 40 mm. The diaphragm can be made of any convenient material, some of which is substantially inelastic, i.e., non-flexible. In some cases, the material has a hardness ranging from Shore 10A to Shore 90A, or Shore 30A to Shore 90A, such as Shore 50A, and a thickness between 0.5 mm and 5 mm, such as 1.0 mm to 2.5 mm. Examples of suitable diaphragm materials include, but are not limited to: silicone, rubber, polyurethane, synthetic or natural polymers, elastomers, fabrics, woven and nonwoven fibers, etc. In some cases, the diaphragm material can 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, such as additional layers of material. Where necessary, biasing components, such as springs, can be provided to provide a default or baseline diaphragm position and / or shape and / or configuration. For example, a spring can 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 diaphragm.

[0072] As described above, in this embodiment, the diaphragm is a flexible, impermeable membrane that converts pulsating pneumatic pulses (i.e., those of the proximal chamber) into pulsating fluid pulses (i.e., those of the distal chamber). In this 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 chambers and the atmosphere.

[0073] In an embodiment, applying pulsating energy between the proximal and distal chambers requires longitudinal movement of the diaphragm from a proximal position to a distal position (i.e., translation of the diaphragm in both distal and proximal directions). The diaphragm of the present invention is configured such that this longitudinal movement causes at least two effects: (1) applying a “water hammer” effect of the pulsating energy to the fluid in the distal chamber and ultimately to a tissue-bonding element operatively connected to an amplifier assembly, such as a distal balloon operatively connected to an amplifier assembly, and to the surrounding tissue; and (2) continuously increasing the volume delivered to such a distal tissue-bonding element, such as increasing the volume in the distal balloon, because the tissue surrounding the tissue-bonding element (e.g., the distal balloon) is softened (i.e., with fatigue and / or rupture of calcium deposits).

[0074] proximal nasal

[0075] As described above, the amplifier assembly of this embodiment includes a proximal nose, which includes a distal facet. In an embodiment, the amplifier assembly is configured such that a diaphragm is sealed between the proximal nose and the distal waveguide, separating the proximal chamber from the distal chamber, and is further configured such that the diaphragm translates between the distal facet of the proximal nose and the proximal facet of the distal waveguide. In an embodiment, the diaphragm is compressed between the proximal nose and the distal waveguide, thereby sealing the proximal chamber from the distal chamber. In an embodiment, the diaphragm translates between the distal facet of the proximal nose and the proximal facet of the distal waveguide without inducing strain on the diaphragm.

[0076] The proximal nose can vary in shape. In some cases, the proximal nose is substantially cylindrical. In others, the shape of the proximal nose includes a collar on the opposite proximal side and / or another collar on the opposite distal side. In some cases, the proximal nose includes a central region shaped to form a proximal chamber on one side (i.e., the opposite distal side) and a proximal interface with a high-voltage connector on the other side (i.e., the opposite side, the opposite proximal side). In embodiments, the proximal nose can have any convenient diameter, such as a diameter ranging from 2.5 mm to 100 mm, for example, 5 mm or 50 mm, and any convenient length (i.e., the length along the long axis of the amplifier assembly), such as a length ranging from 50 mm to 500 mm, for example, 100 mm or 250 mm. In embodiments, the proximal nose can be formed of any convenient material; for example, the proximal nose can be molded plastic, rubber, ceramic, or metal. In some cases, dissimilar materials are molded, mechanically attached, or adhered to the proximal nose material, such as plastic, metal, or rubber ends molded, mechanically attached, or adhered to. When present, the dissimilar material can be overmolded to associate, join, or bond the dissimilar material to the material of the proximal nose. For example, the dissimilar material can be overmolded such that a cooled plastic element shrinks onto a metal insert, regardless of the cooling direction.

[0077] In this embodiment, the proximal nose is shaped to form a proximal chamber, which is a geometric cavity within the proximal nose in which a high-pressure pneumatic fluid, such as a high-pressure gas like air or carbon dioxide, expands as it exits the high-pressure connector (as described herein) and impacts the proximal side of the diaphragm. This interaction causes the diaphragm to displace distally and generate a pneumatic pulse. The shape of the proximal chamber (also referred to in this embodiment as a pneumatic amplifier cavity) minimizes the volume of the pneumatic pulse, allowing the pressure to rise rapidly, while maximizing the area that can withstand the pressure pulse (i.e., the area of ​​the diaphragm). This enables the achievement of an effective pulse with minimal fluid (e.g., high-pressure gas) waste. Furthermore, the geometry of the proximal chamber prevents oversaturation and maintains linear output from the frequency and displacement sensors during use of the amplifier assembly.

[0078] In embodiments, the proximal nose is shaped to include a groove, such as a ring (i.e., a ring around the outer periphery), which is an annular groove capable of receiving the circumferential protrusions of the diaphragm described herein (e.g., in some cases, such a groove is configured to receive an O-ring attached to the diaphragm). The groove may have a radially arranged recess-retaining geometry that controls the position and deformation / compression of the circumferential protrusions of the diaphragm (e.g., the O-rings attached thereto). Once the circumferential protrusions of the diaphragm are in place, the groove restrains the diaphragm from being pulled out of the groove and maintains a seal as the diaphragm cycles under various pressures and displacements.

[0079] In some cases, the proximal nose includes a proximal interface located in the proximal region of the proximal nose. The term "proximal interface" refers to the proximal side or face of the proximal nose. In some cases, the proximal interface is configured to mate with a handle assembly. In embodiments, the proximal interface includes a high-voltage connector; that is, a connector fluidly connected to the proximal chamber, allowing the amplifier assembly to receive energy, such as high-pressure fluid, like high-pressure air or carbon dioxide, or first pulse energy, pneumatic or static energy, generated by an energy source operatively connected to the amplifier assembly via a handle assembly that mates with the amplifier assembly at the proximal interface via the high-voltage connector.

[0080] In 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, either manufactured as part of the proximal nose or added to the proximal nose as a separate component. When the high-voltage connector is added to the manufacturing of the proximal nose, the high-voltage connector material can be metal, i.e., a metal component 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 materials. While the dimensions of the high-voltage connector can vary as needed, in some cases, the outer diameter ranges from 1 mm to 30 mm, for example, 3 mm to 8 mm, and the inner diameter ranges from 1 mm to 30 mm, for example, 2 mm to 7 mm. When the proximal nose has a high-voltage connector, the length of the high-voltage connector can range from 1 mm to 50 mm, for example, 3 mm to 10 mm.

[0081] In cases where the proximal nose includes a high-pressure connector, the proximal chamber of the proximal nose is fluidly coupled to the high-pressure connector. In this case, the connection between the high-pressure connector and the proximal chamber may include a nozzle and / or a diffuser, which in some cases may be geometrically formed by the proximal nose. In this case, the nozzle or diffuser can be used to increase or decrease the flow rate of the fluid (e.g., high-pressure gas), but at the cost of fluid pressure. By increasing or decreasing the fluid flow rate, the characteristics of energy conversion (i.e., between a first energy applied to the proximal chamber and a second energy applied to the distal chamber; from a first pulse energy to a second pulse energy) can be improved, such as rise time or the smoothness of energy conversion. In the case of pneumatic flow, the gas velocity may be high enough to cause compressible fluid phenomena, such as in sonic or supersonic flows. In this case, specialized flow nozzles, such as convergent-diffuser nozzles, can be used to optimize the flow rate.

[0082] In an embodiment, the high-voltage connector includes an O-ring groove configured to receive an O-ring. Such a groove and an associated O-ring may be included to create a reliable seal on the high-voltage connector, i.e., between the high-voltage connector and the handle assembly. The O-ring groove may be present in the proximal region of the high-voltage connector and may include a grooved retention feature for one or more O-rings. This groove may be present in the proximal region of the high-voltage connector and may have any convenient dimensions, i.e., any convenient depth and width, and these can vary. Therefore, any convenient O-ring, such as a polymer O-ring, can be installed based on the corresponding dimensions of the O-ring groove. In an embodiment, the high-voltage connector and the O-ring retained on or inside the high-voltage connector are inserted into a mating receptacle, i.e., a receptacle of the handle assembly, thereby creating a reliable high-voltage seal.

[0083] In other embodiments, this reliable high-pressure seal is achieved through an end-face seal, wherein a sealing gasket is pushed against a smooth surface (e.g., the surface of a handle assembly) to produce a reliable seal. Additional embodiments may include non-polymer O-rings or washers, tubes or tube compression / expansion fittings, push-in pneumatic plugs and socket receivers, medical Luer connectors or other connectors and / or combinations thereof.

[0084] In some embodiments, the proximal interface includes alignment features, such as bonding surfaces. These alignment features, such as bonding surfaces, are used to align the proximal interface of the proximal nose with the handle assembly when both are operably connected. For example, the bonding surface can control the rotational, axial, and radial position of the amplifier assembly relative to the mating reception portion of the handle assembly. Furthermore, the term "bonding surface" means that the proximal interface includes one or more features that, in some cases, have rotational asymmetry, such that the bonding surface allows the proximal interface to mate with the handle assembly in only one rotational orientation (i.e., about the major axis of the amplifier assembly or perpendicular to the axis of the handle assembly). The bonding surface can be used to align the proximal nose with the handle assembly so that the elements of each component are aligned when operably connected. For example, the amplifier and handle assembly may need to be aligned so that the electrical connectors on each component are correctly aligned with each other. Any convenient bonding mechanism can be used on the proximal interface of the proximal nose, such as recessed positioning, asymmetric channels, elliptical shapes, and rectangular prisms. These elements can include any convenient dimensions as needed. Furthermore, internal features (such as slots or grooves) can be used to further constrain the position of the interlocking features of the amplifier assembly. A stop element can be used to set the axial depth of the amplifier assembly within the receiving portion of the handle assembly. These features can act individually or in combination to constrain the rotational, axial, and radial position of the amplifier assembly within the receiving portion of the handle assembly.

[0085] In some embodiments, the handle assembly and amplifier assembly may include one or more sensors configured to confirm 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 operatively 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 confirm that the distance and / or orientation between the handle assembly and amplifier assembly is expected or specified. The handle assembly and amplifier assembly may include Hall sensors configured to function as a connection / disconnect switch. In some cases, the Hall sensor may include a magnet located on the handle assembly and a probe located on the amplifier assembly, or vice versa. In other cases, the magnet may be located on each of the handle assembly and amplifier assembly, while the probe may be located on either the handle assembly or the amplifier assembly. When present, the Hall sensor may be calibrated to measure the distance between aspects 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 one embodiment, the handle assembly is configured with one or more interlocking devices such that energy cannot be transferred (e.g., to the remote interface of the handle assembly) when the Hall sensor fails to confirm that the handle assembly and the amplifier assembly are operatively connected.

[0086] In embodiments, the proximal nose is shaped to include a flexible electronics compartment on which aspects of the electrical components described herein are mounted. In some cases, the proximal nose is further shaped to include guides for attaching aspects of the electronic components. That is, in embodiments, the flexible electronics compartment and the guides position the electronic components or aspects thereof, such as flexible printed circuit boards, such that a repeatable connection can be established between the electrical connectors of the amplifier assembly (i.e., the electrical connectors) and the corresponding connectors of the handle assembly. This guide segment of the proximal nose can be used to position and connect aspects of the electronic components, such as flexible printed circuit boards, during assembly and use, so that, for example, the flexible circuit board or other components are not pinched or damaged.

[0087] In embodiments, the proximal nose may be shaped to include a housing retaining feature. This feature positions one or more aspects of the housing (as described herein) relative to the proximal nose. This feature may also be used to lock (i.e., retain) the housing in a final position. In some embodiments, the housing retaining feature may be a mating groove or ridge, a bump, a gap, a press fit, or a pin / screw hole, etc. In other embodiments, the proximal nose is configured to include a distal waveguide positioning guide. When present, the distal waveguide positioning guide is a feature of the proximal nose (e.g., the proximal nose is shaped to include such a positioning guide) that positions the distal waveguide during assembly and ensures that the distal waveguide is assembled relative to the proximal nose in the desired position and orientation.

[0088] In some cases, the proximal nose is further configured to include a distal waveguide retaining region or retaining features. When included, this retaining region is a set of features that ensure proper compression loading of the distal waveguide and diaphragm relative to the proximal nose during assembly. These features further secure the distal waveguide once positioned and / or oriented as desired. In some embodiments, the distal waveguide retaining region is a set of holes that receive hardware, such as pins, screws, bolts, etc., configured to control and lock the compression distance of the amplifier assembly, i.e., control and lock the position of the proximal nose, the distal waveguide, and the diaphragm compressed therein. In other embodiments, the distal waveguide retaining region is a set of deflection and interlocking features that, once engaged, prevent the distal waveguide from being removed from the proximal nose (and the diaphragm compressed therein). Such other features may include, for example, a cable tie mechanism or other one-way ratchet mechanism. In other embodiments, the distal waveguide retaining region represents a location for thermal riveting, thermal deformation, laser welding, or ultrasonic welding, i.e., securing the distal waveguide in a position relative to the proximal nose with the diaphragm compressed therein. In other embodiments, the retaining feature may include a feature located at a selected position on the proximal nose, corresponding to a specific position of the distal waveguide when the proximal nose and distal waveguide are brought together, such as a position corresponding to a relative distal position of the distal waveguide or a relative proximal position of the distal waveguide, or a combination thereof. This retaining feature may include, for example, any convenient adhesive, such that the retaining feature distributes compressive loads from the distal waveguide to the proximal nose. In some embodiments, the retaining feature includes a region of the assembly, such as a distal region or a proximal region, potted with an adhesive. Such adhesive potting may partially distribute compressive loads from the distal waveguide to the proximal nose.

[0089] As described herein, the proximal nose of interest and the handle assembly operably connected thereto are capable of receiving fluid, particularly fluid subjected to pressure oscillations during use. In embodiments, a fluid (e.g., a gas) is introduced into the proximal nose through the handle assembly, and this fluid is subjected to pressure oscillations. Any readily available fluid, or a purged fluidless / gase, such as a vacuum or a very low-pressure fluid, can be applied, and these can vary. When the fluid is a gas, gases of interest include air or carbon dioxide or nitrogen, helium, nitrous oxide, argon, water vapor, phase change refrigerants, and coolants; in each case, the gas can be sterile.

[0090] remote waveguide

[0091] As described above, the amplifier assembly of this embodiment includes a distal waveguide including a proximal end face. In one embodiment, the amplifier assembly is configured such that a diaphragm is sealed between the proximal nose and the distal waveguide, separating the proximal chamber from the distal chamber. In other embodiments, the amplifier assembly is configured such that a diaphragm is compressed between the proximal nose and the distal waveguide to seal the proximal chamber from the distal chamber, and is further configured such that the diaphragm translates between the distal end face of the proximal nose and the proximal end face of the distal waveguide.

[0092] The form of the distal waveguide can vary in embodiments, where in some cases it is substantially conical or substantially cylindrical. In some cases, the distal waveguide shape includes a relatively proximal portion (substantially conical) and a relatively distal portion (substantially cylindrical). In some cases, the distal waveguide includes a region shaped to form a distal chamber on the relatively proximal side, which is opposite to and fluidly connected to a conduit interface located on the relatively distal side. In embodiments, the distal waveguide can have any convenient diameter, i.e., a maximum diameter, for example, ranging from 10 mm to 100 mm, such as 25 mm or 50 mm, and any convenient length (i.e., the length along the long axis of the amplifier assembly), for example, ranging from 25 mm to 250 mm, such as 50 mm or 75 mm. In embodiments, the distal waveguide can be formed of any convenient material; for example, the distal waveguide can be molded plastic, rubber, ceramic or metal, and in some cases, dissimilar materials are molded, mechanically attached or adhered to the distal waveguide material, such as molded, mechanically attached or adhered to the plastic, metal or rubber end of the distal waveguide.

[0093] Embodiments of the distal waveguide are shaped to include a fluid pathway originating at the distal end of the diaphragm and comprising a distal chamber of the distal waveguide and a catheter interface (as described herein). This fluid pathway, after exiting the distal waveguide, can continue through a flexible tube, Y-joint, catheter, and ultimately to a balloon. This fluid pathway is filled with fluid (e.g., saline, a saline-contrast mixture, or other fluids or fluid mixtures commonly used in interventional practice (i.e., interventional cardiology)) to form a fluid column. This fluid column is pulsed by a hydraulic shock or water hammer effect, where the fluid transmits pressure waves from the distal end of the distal waveguide to a tissue-attached element, such as a distal balloon, which is operatively connected to the amplifier assembly via a catheter. Subsequent volume changes occur within this distal balloon to produce a pulsating effect. As calcification ruptures and the diseased vessel becomes more compliant, the diaphragm of the amplifier assembly delivers a greater volume of fluid to the tissue-attached element, such as the distal balloon.

[0094] In some embodiments, the distal waveguide includes a funnel-shaped geometry configured to guide pressure waves into the fluid channel. This configuration of the distal waveguide also helps to ensure support for the distal side of the diaphragm and prevent rupture in the event of rapid expansion or rupture of the balloon operatively connected to the amplifier assembly. In embodiments, the internal bell shape of the distal waveguide provides structured maximum volumetric expansion, limiting diaphragm displacement and elastic stress. The distal waveguide can be configured, for example, to include an internal shape that helps ensure smooth flow vector transmission from the diaphragm to the fluid channel (i.e., the conduit interface) and minimizes turbulence in this flow.

[0095] Similar to the description herein regarding the proximal nose, the distal waveguide may include or be shaped to include a groove, which is a ring (i.e., a ring around the outer periphery) that receives the circumferential protrusions of the diaphragm described herein (in some cases, such a groove is configured to receive an O-ring attached to the diaphragm). The groove has a radially arranged recess-retaining geometry that controls the position and deformation / compression of the circumferential protrusions of the diaphragm (e.g., the O-rings attached thereto). Once the circumferential protrusions of the diaphragm are in place in such a groove in the distal waveguide (and the corresponding groove in the proximal nose), the groove constrains the diaphragm from being pulled out of its compressed position and configuration between the distal waveguide and the proximal nose, and maintains a seal as the diaphragm cycles under various pressures and displacements.

[0096] In one embodiment, the distal waveguide includes a portion with a funnel-shaped geometry that guides pressure waves into the fluid channel. The distal waveguide also ensures support for the distal portion of the diaphragm in the event of rapid balloon expansion or rupture, and prevents bursting. The shape of the distal waveguide ensures smooth flow vector transmission from the diaphragm to the fluid channel and minimizes turbulence in this flow.

[0097] In an embodiment, the distal waveguide includes a catheter interface located in a distal region of the distal waveguide. A catheter interface is an interface that provides fluid connection to the distal waveguide and is configured to attach to, for example, a catheter (i.e., a catheter assembly). The distal waveguide is configured such that fluid present in the distal chamber (e.g., saline) can be propelled by a diaphragm through the catheter interface to, for example, a distal balloon or other tissue-attached element operatively connected to the output of an amplifier assembly. That is, when the amplifier assembly receives energy (e.g., first pulse energy, pneumatic or static energy) generated by an energy source operatively connected to the amplifier assembly and converts this energy into second pulse energy or static energy within the distal chamber, this second energy or second pulse energy (e.g., a high-pressure fluid, such as a high-pressure fluid containing saline) can be transferred from the distal chamber to the catheter interface. In an embodiment, the catheter interface is fluidly connected to the distal chamber. In some cases, the catheter interface includes a Luer lock, such as a floating Luer lock. While the size of the conduit interface can vary as needed, in some cases, the outer diameter of the conduit interface ranges from 2 mm to 20 mm, for example, 5 mm to 10 mm, and the inner diameter ranges from 1 mm to 10 mm, for example, 4 mm to 8 mm. When the distal waveguide has a conduit interface, the length of the conduit interface can range from 2.5 mm to 25 mm, for example, 4 mm to 12 mm.

[0098] Embodiments of the distal waveguide also include (i.e., can be shaped to include) a retaining region, which is, for example, a region on the distal area of ​​the distal waveguide, configured to retain the distal waveguide relative to the proximal nose (e.g., inside it or against it) after an appropriate compression depth has been established (i.e., appropriate compression of the diaphragm between the proximal nose and the distal waveguide). In some embodiments, the retaining region serves to distribute the load of pulsating pressure waves from the amplifier assembly across the entire distal surface of the distal waveguide. In other embodiments, the retaining region is the location of thermal riveting, ultrasonic welding, potting, or other techniques used to combine the proximal connector nose and the distal waveguide.

[0099] In some embodiments, the amplifier assembly further includes a pin, such as a steel pin, which is a retaining pin configured to maintain a sealed engagement between the distal waveguide and the diaphragm and the proximal nose. In embodiments, the distal waveguide is shaped such that the pin can be placed on the distal side of the distal waveguide to apply force in a direction relative to the proximal end. In embodiments, such a pin can be placed through a hole or slot in the distal region of the proximal nose (i.e., the distal collar of the proximal nose) such that the pin abuts against the distal side of the distal waveguide.

[0100] In embodiments, the distal waveguide is shaped to include a guide for attaching electronic components. That is, in embodiments, the flexible electronic guide positions and / or protects electronic components or aspects thereof, such as flexible printed circuit boards, such that connections can be made to different parts of the amplifier assembly and / or repeatable connections can be established between the electrical connectors of the amplifier assembly and corresponding connectors of the handle assembly. This guiding segment of the distal waveguide can be used to position and connect and / or protect aspects of electronic components, such as flexible electronic devices, during assembly and use, so that, for example, flexible circuit boards or other components are not clamped or damaged.

[0101] As described herein, the distal waveguide can be operatively connected, ultimately to a distal balloon or other tissue bonding element via, for example, a Luer lock connected to a flexible tube, a Y-connector, and one or more catheters. In an embodiment, the Luer lock segment is connected to a flexible tube, which is connected to a Y-connector on the catheter. These components partially function as stress relief elements between the amplifier assembly and the catheter. These components are configured to transmit pulsating pressure waves between the amplifier assembly and the catheter, and ultimately to the distal balloon or other tissue bonding element.

[0102] As described herein, the distal waveguide of interest, and the conduit operatively connected thereto, are capable of receiving fluids, particularly fluids subjected to pressure oscillations during use. In embodiments, a fluid (e.g., a liquid) is introduced into the distal waveguide, for example, via a microcatheter or other component fluidly connected to the distal waveguide, and this liquid is subjected to pressure oscillations. Any convenient fluid can be applied, and these can be varied. When this fluid is a liquid, liquids of interest include water or saline solutions (with or without contrast agents or other radiopaque fluids or fluorocarbons or perfluorocarbons), in which case the liquid may be sterile. Other liquids of interest include iodine-based fluids, barium sulfate, gadolinium, or other radiopaque contrast agents, in which case the liquid may be sterile.

[0103] Electrical components

[0104] In embodiments, the amplifier assembly further includes electrical components (also referred to as electronic components) integrated into one or more of the proximal nose, distal waveguide, and diaphragm. The electrical components can be configured to perform various functions as needed, including, for example, powering various sensors of the entire amplifier assembly or external to it, controlling such sensors, receiving data from such sensors, recording and / or transmitting (e.g., wirelessly) such data to another location, controlling various aspects of the amplifier assembly or aspects external to the amplifier assembly, and / or storing information about the amplifier assembly or its connected handle assembly or other aspects of the system to which the amplifier assembly is connected.

[0105] In some cases, the electrical component includes a controller programmed to perform self-test and / or self-diagnostic procedures to verify the safety of the amplifier assembly, for example. In one embodiment, the electrical component is a flexible printed circuit board configured to perform several functions, including, for example, establishing an electrical connection to the handle assembly, measuring the pressure of fluid in the distal chamber using sensor readings, measuring the position of the diaphragm center using sensor readings, and storing or retrieving such information from memory for the catheter, balloon (or other tissue-attached element) and / or other treatment-specific information.

[0106] Electrical components may vary and, in some cases, may include circuitry and / or memory. When present, memory may store various types of information, including but not limited to: information about the amplifier assembly and / or its components or operatively connected components (e.g., the handle assembly or, for example, the distal balloon (or other tissue-attaching element)), or related information such as expiration date, batch number, balloon size (e.g., balloon diameter and length), balloon rated burst pressure and nominal pressure, cycle limits (e.g., the rated number of permissible cycles for the balloon), and the number of cycles used, permissible pulse frequency or duration, previous use, balloon reference pressure-volume curve, and / or indications for use, etc.

[0107] Electrical components can be present in any convenient configuration, such as printed circuit boards, including flexible printed circuit boards. In some cases, electronic components can transmit data wirelessly, for example via Bluetooth RF. In some cases, electrical components include one or more microprocessors, such as one or more microcontrollers. Microprocessors of interest include commercially available processors, such as general-purpose or other special-purpose processors, controllers, microcontrollers, application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), special-purpose digital and / or analog circuits, or other logic circuits. Such microprocessors may include one or more memories. Memories of interest include commercially available memories, such as volatile and non-volatile memory chips, devices, or systems. Electrical components can be mounted on other aspects of the near-nose or far-end waveguide or amplifier assembly as needed.

[0108] When present, the electrical component may further include connectors for operatively connecting the electrical component to the handle assembly. In embodiments, the electrical component includes multiple electrical connectors integrated into the proximal interface. The number of electrical connectors can vary as needed. Electrical connectors of any convenient form can be used. For example, the proximal interface can 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 connectors include multiple plates configured to mate with multiple ball connectors (i.e., the ball connectors of the handle assembly). The electrical connectors may include a ground plane that spans the entire length of the multiple electrical connectors, i.e., such that a ground connection is the first electrical connection made with, for example, the corresponding electrical connector of the handle assembly, and the last electrical connection disconnected with, for example, the corresponding electrical connector of the handle interface. The electrical connectors can be used in any convenient manner, and these can vary, including, for example, power connections, ground connections, connections for transmitting and / or receiving data and / or control signals, etc.

[0109] pressure sensor

[0110] Embodiments of the amplifier assembly further include a pressure sensor configured to sense fluid pressure within a distal waveguide. The pressure sensor can be configured to sense the pressure ultimately output by the amplifier assembly, such as the pressure ultimately output through a conduit interface of the distal waveguide. The pressure sensor can also be configured to sense pressure applied to, for example, a distal balloon operatively connected to the amplifier assembly. In some cases, the amplifier assembly includes a pressure sensor operatively coupled to a distal chamber. In this case, the pressure sensor can detect the pressure of the liquid in the distal chamber and changes therein. When included, any convenient type of pressure sensor can be present, examples of which include, but are not limited to, resistive, capacitive, piezoelectric, optical, and MEMS-based pressure sensors.

[0111] In one embodiment, the pressure sensor is integrated into a distal waveguide. For example, the distal waveguide may be shaped to include a fluid connection and / or mounting for the pressure sensor at a location distal to the distal chamber. In another embodiment, the pressure sensor is electrically connected to electrical components, wherein such connection, for example, powers the pressure sensor, receives an output signal from the pressure sensor, or controls the pressure sensor.

[0112] Some embodiments of the remote waveguide include a pressure sensor housing for accommodating a pressure sensor. The pressure sensor can be secured to the remote waveguide by adhesives, thermal riveting, ultrasonic welding, internal O-ring seals or O-ring end face seals, fixing screws with interference fits, or other sealing methods.

[0113] In other embodiments, the pressure sensor can be attached to a remote Luer lock operatively connected to a remote waveguide via a T-connector on the Luer lock.

[0114] Position / volume sensor

[0115] Embodiments of the amplifier assembly further include a sensor configured to sense the position of the diaphragm. The term "diaphragm position" refers to the location of the diaphragm relative to its neutral, central position in a direction relative to the distal or proximal end. The term "diaphragm position" also refers to the location of the central region of the diaphragm. Furthermore, the term "diaphragm position" refers to the location where the diaphragm is indicated to be extended from the output of the amplifier assembly (e.g., from a conduit interface of a distal waveguide) and into a fluid volume, such as a distal balloon or other tissue-connecting element operatively connected to the output of the amplifier assembly.

[0116] In other words, in some cases, the amplifier assembly includes a position sensor configured to provide spatial data about the position of the diaphragm at a given time, such as during use of the amplifier assembly or the system formed therefrom. Any convenient position sensor can be used, where applicable. In some cases, the diaphragm position sensor is a Hall sensor, which, for example, can be used in conjunction with a magnet (e.g., a permanent magnet or electromagnet) or two or more magnets present at one or more fixed positions relative to the diaphragm (e.g., fixed positions of the amplifier assembly or handle assembly, etc.), such that the fixed magnet is positioned to modulate the voltage of the Hall sensor when the diaphragm moves (i.e., translation of the diaphragm in the proximal and distal directions).

[0117] For example, a position sensor may include 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 this case, the electrical probe is configured such that movement of the diaphragm relative to the first and second magnets causes a detectable change in current or voltage, for example, in a probe located in the central region of the diaphragm, this change indicates the position of the diaphragm.

[0118] In some cases, the proximal nose includes a first container configured to hold a first magnet in a fixed position, and / or the distal waveguide includes a second container configured to hold a second magnet in a fixed position. In embodiments, the first and second magnet containers provide a location for securing the magnet in a desired position. Deformation features molded into the proximal nose and distal waveguide can be used to hold the magnet without additional holding mechanisms or processes. Deformation features may include, for example, clamping ribs or other protrusions designed to hold the magnet in a fixed position. Furthermore, a rear stop limiting feature can be used to position the depth of the magnet relative to other elements, such as displacement and frequency sensors. That is, embodiments may include features, such as specific shapes, to constrain or otherwise precisely position one or more magnets relative to other elements of the system. In embodiments, the magnetic field of one or more magnets induces electrical activity or characteristics, such as changes in current and / or voltage, on a Hall sensor or probe. Such changes in electrical activity or characteristics are directly related to the distance from the magnetic poles of the magnetic field to the Hall sensor or probe. This electrical activity or characteristic can be calibrated to directly measure diaphragm displacement and indirectly measure volume changes (e.g., changes in the volume of fluid removed; e.g., changes in the volume of proximal and / or distal chambers).

[0119] In some cases, the proximal nose and / or distal waveguide are shaped such that the first and second containers include clamping ribs, i.e., protrusions or bumps that can be compressed to hold the magnet under tension within the container. In one embodiment, an electrical probe located in the central region of the diaphragm is electrically connected to electrical components, such as powering and / or receiving data from and / or controlling the sensor. In other embodiments, the position sensor includes integrating the magnet into the central region of the diaphragm.

[0120] In other cases, the position sensor can be an optical sensor, an electric field / potential sensor, a resistive sensor, a magnetic sensor, an angle sensor, or an accelerometer. Furthermore, any combination of these sensors can be used to collect diaphragm position data. When employing a combination of diaphragm position sensors, for example, to ensure that the sensors provide correct data at various frequencies, the sensor data can be combined using techniques known in the art, such as "sensor fusion." When present, the position sensor can be used for a variety of different purposes, such as assessing vascular compliance and treatment efficacy, evaluating the proper inflation of a balloon operatively connected to the output of an amplifier assembly, providing a method for assessing whether the diaphragm has been stretched beyond a desired threshold, etc. Methods of manufacturing the position sensor may include, but are not limited to, adhesive bonding, direct printing, welding, embedding, etc.

[0121] As described above, regarding the inclusion of a position sensor (e.g., a Hall sensor) in embodiments of the amplifier assembly, the diaphragm can be configured to include flexible electronic guides and a position sensor holding region, wherein these aspects interact with electrical components. In some embodiments, an aspect of the position sensor (e.g., a Hall sensor or Hall sensor probe) is attached to the center of the diaphragm, providing an electronic output (e.g., a voltage output) corresponding to the center position of the diaphragm. The center position of the diaphragm corresponds to the volumetric output of the amplifier assembly provided by the sensor.

[0122] Aspects of the position sensor and / or electrical components (e.g., flexible circuit boards) may include thin, rigid plates that are difficult to seal, making it difficult to prevent fluid from escaping from the proximal and / or distal chambers. To create a seal without damaging the aspects of the electrical components (e.g., flexible circuit boards), while also creating a seal between the proximal nose and the distal waveguide, the diaphragm may include a flexible electronic guidance region. This region may include creating a small slit in the diaphragm (e.g., a circumferential protrusion of the diaphragm; an external circumferential O-ring of the diaphragm), sized and configured such that aspects of the position sensor and / or electrical components (e.g., one or more electrical connections to the electrical components or flexible circuit boards) can be transferred from the central region of the diaphragm to a space outside the proximal or distal chamber (e.g., allowing a probe or other aspect of the position sensor, such as a Hall sensor, to be electrically connected to the electrical components while still maintaining the seal of the diaphragm to the proximal and distal chambers). The flexible electronic guidance region of the diaphragm may include a flexible circuit board co-molded with the diaphragm. This region may include thermal riveting to embed such a flexible circuit board within the diaphragm. In an embodiment, the end of the flexible electronic guiding region may include creating multiple sealing surfaces within the diaphragm (e.g., between the proximal side of the groove at the proximal nose (as described herein) and the proximal side of the circumferential protrusion (e.g., an O-ring) of the diaphragm, between the inner side of the circumferential protrusion and the flexible circuit board, and / or between the distal side of the circumferential protrusion and the groove at the distal waveguide (as described herein).

[0123] In embodiments, to reliably hold a position sensor, such as a Hall sensor, on or near the diaphragm during proximal and distal translation of the diaphragm or during pulsatile intravascular lithotripsy, features can be molded into the diaphragm to accommodate aspects of the position sensor, such as a Hall sensor. For example, bumps or ridges can be molded onto the diaphragm, including a recess such that an aspect of the position sensor (e.g., a Hall sensor) can be accommodated therein. This recess can accommodate the position sensor (e.g., a Hall sensor) alone, or it can include an adhesive or very high-strength tape. Adhesives of interest include cyanoacrylates, UV-curable adhesives, or multi-component adhesives. In other cases, the position sensor can be completely co-molded and embedded within the diaphragm. In some embodiments, it is advantageous for aspects of the position sensor and / or electrical connections and / or electrical components (e.g., flexible circuit boards) to include grooves or ridges configured to hook or grip the diaphragm to form an interlocking groove. In other cases, aspects of the position sensor can be thermally riveted or ultrasonically welded to the diaphragm.

[0124] case

[0125] Different components of each of the handle assembly and amplifier assembly may reside within a housing, including, in some cases, within a single housing. This housing encloses the various components of the handle assembly and amplifier assembly to protect internal components. This housing may substantially cover the proximal nose, distal waveguide, and diaphragm, as well as other components of the amplifier assembly, as needed. In embodiments, the housing is configured to cover and protect the components housed therein, i.e., to protect internal components from environmental exposure and / or abrasion caused by the introduction of foreign objects. While the form of the housing may vary, in some cases, the housing of the handle assembly and amplifier assembly includes one or more snap-fit ​​shells configured to substantially enclose internal components, such as the proximal nose, distal waveguide, and diaphragm. In embodiments, the housing includes a shell, snap-fit, and an outlet port (i.e., a port for connecting the output to the amplifier assembly; i.e., a space configured to allow ductwork or other aspects to be operatively connected, for example, to a duct 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 employed, allowing the handle assembly and amplifier assembly to be operatively connected in a safe and efficient manner during use. In this embodiment, the user can easily disconnect the amplifier assembly and the handle assembly by releasing the latch and engaging the lock.

[0126] When present, the housing may also cover electrical components; however, the shape of the housing may allow electrical connectors of the electrical components to be exposed or made available for connection with other components or systems, such as handle assemblies.

[0127] In embodiments, the housing may also be configured to hold the amplifier system to the handle assembly, for example, during use. In some cases, the housing includes one or more flexible arms for mating with the handle assembly. These one or more flexible arms may be configured to hold the proximal interface of the proximal nose in place relative to the handle assembly. In embodiments, the flexible arms are "click-fit" and are bilaterally oriented to provide "quick-connect" retaining features that, when properly oriented and positioned, "click" into a mating receptacle (e.g., a receptacle of the handle assembly). These click-fit features may bend outwards such that they are compressed during insertion (i.e., insertion into the mating receptacle of the handle assembly) and then return to their original position while in their mating receptacle. Once the flexible arms (i.e., the click-fits) return to their original position, the retaining features lock into their respective receptacles (i.e., the receptacles of the handle assembly) to prevent longitudinal movement (i.e., disengagement of the amplifier assembly from the handle assembly). To release the amplifier assembly, the flexible arms (i.e., the click-fit arms) may be compressed inwards to release the retaining features from their respective receptacles. Once the latch engagement lock is released, the amplifier assembly can be disconnected from, for example, the handle assembly.

[0128] In embodiments, the housing may be configured to provide a unit configured for handheld use. In this case, the handheld component, such as a handheld amplifier assembly, is designed to be held and operated with a single adult hand. When present in embodiments, one or more flexible arms may be configured to provide tactile feedback for docking with the handle assembly.

[0129] One or more flexible arms may include aspects of a snap-fit ​​groove mechanism for the amplifier assembly. In an embodiment, the snap-fit ​​groove allows flexible interlocking retention features 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.

[0130] In some cases, the housing includes one or more recessed segments or grip points configured for manual gripping of the amplifier assembly. In particular, such recessed segments or grip points may be configured to facilitate operation of the amplifier assembly while wearing gloves, as this may be necessary in the operating environment.

[0131] Although the shape factor of such a housing can vary as needed, in some cases, the typical diameter and / or length of such a housing ranges from 25 mm to 100 mm, for example 40 mm to 50 mm, and the length ranges from 50 mm to 150 mm, for example 75 mm to 100 mm.

[0132] Additional details regarding aspects or related components of amplifier assemblies that may be incorporated into or used in conjunction with embodiments of the present invention are provided in the following patents: U.S. Patent No. 11,464,949; Pending PCT Application Serial No. PCT / US2020 / 055458; U.S. Application Serial No. 63 / 274,832; Pending PCT Application Serial No. PCT / US2022 / 014785; U.S. Application Serial No. 63 / 238,381; Pending PCT Application Serial No. PCT / US2022 / 040586; U.S. Application Serial No. 63 / 346,703; Pending PCT Application Serial No. PCT / US23 / 23533; U.S. Application Serial No. 63 / 346,704; Pending PCT Application Serial No. PCT / US23 / 22685; and U.S. Application Serial No. 63 / 444,414; the disclosure of each of these is incorporated herein by reference.

[0133] The various aspects of the amplifier assembly of the present invention have been generally described above. Now, the elements of the amplifier assembly will be further reviewed in the context of specific embodiments. Specific Implementation

[0134] Amplifier components according to embodiments of the present invention, such as Figure 1B As shown. Figure 1B An isometric view of amplifier assembly 100 is shown, with the relatively proximal region of amplifier assembly 100 appearing on the right side of the figure and the relatively distal region of amplifier assembly 100 appearing on the left side of the figure.

[0135] Amplifier assembly 100 includes a proximal nose 110 visible in a relatively proximal region of amplifier assembly 100. Proximal nose 110 includes a proximal interface 120. As described herein, the amplifier assembly of interest is associated with handle assembly 101 (e.g., Figure 1C The proximal interface 120 of the proximal nose 110 is mated with the corresponding interface of the handle assembly, and operatively connected. A high-pressure connector 123 is located at the center of the proximal interface 120 and is configured to receive high-pressure fluid (e.g., high-pressure fluid pulses) from a pressure source via a handle assembly operatively connected to the proximal interface 120 of the amplifier assembly 100. The high-pressure connector 123 is configured to provide an interface for high-pressure fluid (e.g., high-pressure fluid pulses), such as high-pressure gas (e.g., compressed air or compressed carbon dioxide), into the proximal chamber within the amplifier assembly 100, thereby facilitating translation of a diaphragm present within the amplifier assembly, thereby pressurizing the distal chamber of the amplifier assembly 100. The high-pressure connector 123 partially seals the high-pressure fluid within the amplifier assembly 100 via an O-ring present in an O-ring groove 125 of the high-pressure connector 123. In the amplifier assembly 100, the high-pressure connector 123 is a metal component molded into the plastic of the proximal interface 120 of the proximal nose 110.

[0136] The proximal interface 120 of the proximal nose 110 can be aligned with the handle assembly 101 using alignment elements or bonding elements 127 (e.g., keyways present on the proximal interface 120). Alignment or bonding elements 127, i.e., bonding surfaces, include recesses 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 operatively connected with a specific, desired alignment (e.g., rotational alignment). For example, alignment elements 127 can mat with corresponding elements of the handle assembly 101 such that the high-voltage connector 123 is properly aligned with a hole on the handle assembly (i.e., operatively aligned or aligned to maintain fluid connection), or the electrical connector 130 of an electrical component is properly aligned with a corresponding electrical connector on the handle assembly (i.e., to establish an electrical connection), maintaining both fluid and electrical connections between the handle assembly 101 and the amplifier assembly 100.

[0137] Electrical connectors 130 of the electrical components of amplifier assembly 100 are located in the upper and outer regions of the proximal interface 120 of the proximal nose 110. Electrical connectors 130 of the electrical components comprise plates made of a conductive material, such as a corrosion-resistant metal. Electrical connectors 130 of the electrical components include plates that are positioned, shaped, set, and otherwise configured to mate with the ball connectors (also called pin connectors) of the handle assembly (i.e., substantially circular electrical connectors positioned by spring bias to physically contact and electrically connect the circular ends of the ball connectors to the plate) when the handle assembly is operably connected to the amplifier assembly. Pin connectors are well known in the art and comprise substantially circular electrical connectors positioned by spring bias to physically contact and electrically connect the circular ends of the ball connectors to the plate. This plate-ball (i.e., plate-pin) connection establishes an electrical connection between components (e.g., the plate of electrical connector 130 and the ball connector of the handle assembly) in a direction perpendicular to the long axis of amplifier assembly 100.

[0138] As described, embodiments of the amplifier assembly are configured to releasably engage with the handle assembly of the present invention, such that the amplifier assembly is operatively connected to the handle assembly. Amplifier assemblies according to embodiments of the present invention (e.g.) Figure 1B The amplifier assembly 100 and the handle assembly 101 according to embodiments of the present invention, such as Figure 1C As shown, the general direction in which the amplifier assembly 100 can be operatively connected to the handle assembly 101 is illustrated, such that the proximal interface of the amplifier assembly 100 can contact the distal interface of the handle assembly 101, such that the two assemblies can be releasably engaged to form an operative connection between them.

[0139] Electrical connectors 130 of the electrical components are arranged in a pattern on the outer region of the proximal interface 120 such that when the amplifier assembly 100 is engaged with the handle assembly, the corresponding electrical connectors (e.g., ball connectors) of the handle assembly are connected to... Figure 1B The electrical connectors 130 of the illustrated electrical components are mated together. The amplifier assembly 100 has nine individual electrical connectors, which are rectangular plates with an extended (i.e., relatively elongated) plate in the center. The central plate corresponds to a ground connection, and its shape and position are such that when an electrical connection is established between the electrical components 130 of the amplifier assembly 100 and the handle assembly, the ground connection is the first electrical connection established, and similarly, when these components are disconnected, the ground connection is the last connection disconnected. This configuration of the electrical components 130, such that the ground connection is the first connection and the last connection is disconnected, is a safety feature of the amplifier assembly 100 and the corresponding handle assembly, designed to help ensure that any accidental charge, such as in the amplifier assembly 100 or the operatively connected handle assembly, is safely released.

[0140] The electrical connector 130 of the electrical component can electrically connect to the output of a sensor present on the amplifier assembly 100. For example, a sensor can be integrated into the amplifier assembly 100 that detects the position of the diaphragm within the proximal and distal chambers (e.g., a Hall effect-based sensor, i.e., a Hall sensor), and the output of such a sensor can ultimately be output to the electrical connector of the electrical component (i.e.,...). Figure 1B (One or more boards of the electrical connector 130). Similarly, a sensor can be integrated into the amplifier assembly 100 to detect pressure within the distal chamber of the amplifier assembly 100, and the output of such a sensor can ultimately be output to another electrical connector of the electrical assembly. Other types of sensors may be present in the amplifier assembly 100.

[0141] Electrical connectors 130 are electrically connected to electrical components that further include electronic circuitry configured to, for example, receive electrical signals output from sensors or other electrical elements of amplifier assembly 100, modulate these signals as needed, and output them to one or more electrical connectors 130. In some cases, the electrical components include memory configured as needed, for example, recording sensor readings over time. Such electronic circuitry may be present, for example, on a circuit board (e.g., a printed circuit board, such as a flexible printed circuit board) located within amplifier assembly 100, such that these aspects are not visible when viewing amplifier assembly 100 from the outside. Electrical connectors 130 may also be used to receive signals transmitted from handle assembly, such as control signals for one or more sensors or control signals for power supply to one or more sensors.

[0142] Typically, the electrical connector 130 can be configured to provide electrical connections to various components of the amplifier assembly 100 as needed. For example, the electrical connector 130 of an electrical component can be used to transmit data about diaphragm position, memory, and / or pressure, and to provide power to sensors as needed.

[0143] The distal waveguide 160 is located in a relatively distal region of the amplifier assembly 100. The output of the distal waveguide 160 (i.e., the output transmitted in the relatively distal direction within the amplifier assembly 100) is connected to a conduit assembly 165, which includes or is ultimately connected to one or more conduits for transmitting energy (e.g., pressure, such as a pressure pulse or static pressure) output from the distal waveguide 160. In other words, the conduit assembly 165 receives energy, such as pressure, such as a pressure pulse or static pressure, which has been received and transmitted by the amplifier assembly 100 and is ultimately output by the distal waveguide 160 of the amplifier assembly. The conduit assembly 165 may include one or more conduits and a housing (e.g., a tube) to enclose such conduits. The conduit assembly 165 may also include one or more stress-relieving aspects, such as flexible tubes or reinforcing tubes (e.g., flexible tubes externally wound with metal springs, etc.), to support the amplifier assembly 100 and associated or interconnected components, such as a handle assembly (e.g., when the amplifier assembly is operatively connected to the handle assembly), a console, etc., relative to the operating environment (e.g., an operating room with a patient).

[0144] The housing 190 provides a durable cover for the internal components of the amplifier assembly 100, such as the proximal nose 110 and the distal waveguide 160, so that the proximal nose 110 and the distal waveguide 160 are substantially enclosed within the housing 190. The housing 190 is formed of one or more elements (e.g., covers) that, when combined as needed, enclose aspects of the amplifier assembly 100. The housing 190 is configured to protect the internal components of the amplifier assembly from wear during use and provides a connector interface for operatively connecting the amplifier assembly 100 to the handle assembly. In the amplifier assembly 100, this interface includes a flexible arm 193. The flexible arm 193 includes a ratchet element for insertion into a receptacle of the handle assembly, holding the amplifier assembly 100 in place relative to the handle assembly and maintaining the operative connection between the amplifier assembly and the handle assembly during treatment. When operably connected to the handle assembly, such a ratchet element of the flexible arm 193 engages when the amplifier assembly 100 (particularly the proximal interface 120 of the proximal nose 110) is operably connected to the handle assembly, providing tactile feedback, such as a "click." The corresponding receptacles on the flexible arm 193 and the handle assembly serve the additional function of aligning the amplifier assembly 100 and the handle assembly when the two components are operably mated, for example, aligning the electrical connector 130 of the electrical component with the corresponding connector of the handle assembly. The flexible arm 193 can be manually manipulated, for example, by manually pressing, to disconnect the amplifier assembly 100 from the handle assembly. The flexible arm 193 may be made of hardened plastic with sufficient strength and rigidity to hold the amplifier assembly 100 in place when mated to the handle assembly. Other mechanisms for reversibly attaching the amplifier assembly 100 to the handle assembly are contemplated.

[0145] The outer surface of the housing 190 is formed with gripping sections 195, which have grooves, treads or other shapes or textures to facilitate manual holding and / or manipulation of the amplifier assembly 100 without causing it to slide or rotate in an undesirable or accidental manner, even when held by a gloved hand.

[0146] Figure 2A This shows an internal view, i.e., a cross-sectional view, of an amplifier assembly 200 according to an embodiment of the present invention. The amplifier assembly 200 may be, for example... Figure 1B The amplifier assembly 100 is shown. Figure 2A In the figures, elements with the same or similar reference numerals have the same... Figure 1A -C has the same or similar features as the corresponding components, unless otherwise explicitly stated.

[0147] In amplifier assembly 200, diaphragm 270 is held within amplifier assembly 200 between proximal nose 210 and distal waveguide 260 by retaining pin 267. In an embodiment, pin 267 is a metal pin, but any material known in the art is contemplated. The metal pin 267 (i.e., retaining pin) present within the amplifier assembly serves to hold diaphragm 270 in place, i.e., by compressing distal waveguide 260 against end nose 210. Metal pin 267 may be inserted into or molded therein (e.g.) such that they contact and abut distal surface of distal waveguide 260. Other techniques may also be employed for holding distal waveguide 260 against end nose 210 when diaphragm 270 is present therebetween.

[0148] In such Figure 2B In another embodiment shown, the diaphragm 270 is held in place within the amplifier assembly 200 between the proximal nose 210 and the distal waveguide 260 by a clip 299. Figure 2B An amplifier assembly 200 without housing 190 is shown. Clip 299 is configured to snap onto the proximal nose 210 and distal waveguide 260 to securely hold diaphragm 270 in a sealed position. Clip 299 further includes tab 298 on the proximal end of clip 299 to further secure diaphragm 270. Tab 298 may bend radially inward at hinge 297, or tab 297 may be rotated inward. In this embodiment, clip 299 is a metal clip, but any material known in the art, such as metals and polymers, is contemplated.

[0149] 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 opposite proximal side of the diaphragm 270, and the distal chamber 262 is sealed on the opposite distal side of the diaphragm 270. The diaphragm 270 is configured to translate back and forth within the proximal chamber 212 and the distal chamber 262 (i.e., relative proximal and relative distal). More specifically, the diaphragm 270 is configured to translate back and forth between the distal face 211 of the (proximal nose 210) and the proximal face 261 of the (distal waveguide 260) (i.e., relative proximal and relative distal). The diaphragm 270 is configured to do so without generating strain on the diaphragm 270. That is, the diaphragm 270 is configured to do so without generating tension on the diaphragm 270 or stretching the material of the diaphragm 270 or being subjected to resistance or stress by the material of the diaphragm 270.

[0150] exist Figure 2A In this configuration, diaphragm 270 is in a neutral, relaxed state, approximately midway between the distal face 211 and the proximal face 261. This state corresponds to relatively equal pressures in the proximal chamber 212 and the distal chamber 262.

[0151] In amplifier assembly 200, diaphragm 270 includes pleats 273 whose shape allows diaphragm 270 to translate between the distal end face 211 of the proximal nose 210 and the proximal end face 261 of the distal waveguide 260. According to diaphragm 270 from... Figure 2A As shown by the distance of translation to the neutral position, the diaphragm 270 is prompted to unfold the pleats 273, thereby presenting a new shape that allows the diaphragm 270 to occupy the new position without inducing strain on the diaphragm 270. For example, the pleats 273 of the diaphragm 270 are positioned and shaped such that when the diaphragm 270 is fully translated to the distal end face 211, these pleats unfold and substantially seamlessly contact or cover the distal end face 211. Similarly, the pleats 273 of the diaphragm 270 are positioned and shaped such that when the diaphragm 270 is fully translated to the proximal end face 261, these pleats unfold and substantially seamlessly contact or cover the proximal end face 261. The diaphragm 270 includes pleats 273 whose shape and positioning allow the diaphragm 270 to adapt within the recesses or bends of the distal end face 211 and the proximal end face 261 when translated to the fully proximal and distal ends, respectively.

[0152] As described above, the proximal nose 210 includes a distal face 211 present on the inner distal surface of the proximal nose 210. The volume between the distal face 211 of the proximal nose 210 and the diaphragm 270 forms a proximal chamber 212. In an embodiment, the proximal chamber 212 receives energy (e.g., pressure, such as a pressure pulse or static pressure) from a fluid (e.g., carbon dioxide) entering the amplifier assembly 200, for example via a high-voltage connector 223 of the proximal interface 220. Such energy (e.g., pressure, such as a pressure pulse or static pressure) from the fluid (e.g., carbon dioxide) entering the amplifier assembly 200, for example via the high-voltage connector 223, is sealed within the high-voltage connector 223 and the proximal chamber 212 by an O-ring present in an O-ring groove 225 of the high-voltage connector 223. The distal face 211 of the proximal nose 210 is shaped such that when the diaphragm 270 is translated in the fully proximal position, the diaphragm 270 itself is positioned on the distal face 211 of the proximal nose 210, that is, the folds 273 or the diaphragm 270 unfold or expand to follow the shape of the distal face 211, so that the diaphragm 270 translates without generating strain on the diaphragm 270.

[0153] As described above, the distal waveguide 260 includes a proximal face 261 present on its internal proximal surface. The volume between the proximal face 261 of the distal waveguide 260 and the diaphragm 270 forms a distal cavity 262. The proximal face 261 of the distal waveguide 260 is shaped such that when the diaphragm 270 is translated in its fully distal position, the diaphragm 270 itself is positioned on the proximal face 261 of the distal waveguide 260; that is, the folds 273 of the diaphragm 270 unfold or expand to follow the shape of the proximal face 261, such that the diaphragm 270 translates without generating strain on the diaphragm 270.

[0154] The distal chamber 262 receives energy, such as pressure, like a pressure pulse or static pressure, as the diaphragm 270 is translated due to the energy (such as pressure, like a pressure pulse or static pressure) applied to the proximal chamber 212. This energy, such as pressure, like a pressure pulse or static pressure, is transmitted along the distal waveguide 260 and ultimately outputs to the 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 a floating Luer lock, or other operable connectors as needed). This catheter interface 264 is fluidly connected to the distal chamber 262 of the distal waveguide 260. This catheter interface 264 receives high-pressure fluid from the distal chamber 262, i.e., high-pressure pulses and / or static pressure. This pressure can be transmitted via fluid (such as saline) in the distal chamber 262.

[0155] In part, to seal the proximal chamber 212 and the distal chamber 262 (i.e., to fluid seal these chambers), the diaphragm 270 includes a generally T-shaped protrusion 275 at the outer periphery of the diaphragm 270. This protrusion is shaped to seal the connection between the proximal nose 210 and the distal waveguide 260, such that even when relatively high pressures (including high-pressure pulses) are applied to the fluid present in either chamber and / or even when the diaphragm 270 is fully translated in the proximal or distal direction, fluid will not escape between these elements.

[0156] As described above, the proximal nose 210 includes a proximal interface 220 for mating with the handle assembly. The proximal interface 220 includes a high-pressure connector 223 for receiving energy (e.g., fluid, such as a fluid pressure pulse or static fluid pressure), where such fluid can be, for example, a gas, such as carbon dioxide or air. This high-pressure connector 223 is fluidly connected to the proximal chamber 212. That is, the high-pressure connector 223 is configured to receive high-pressure fluid, i.e., from the handle assembly, and transmit this pressure to the proximal chamber 212. The high-pressure connector 223 may be made of metal and / or may be molded into a material of the proximal nose 210, such as plastic molded into 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 alignment elements 227, i.e., bonding elements, such as keyways, grooves, or multiple grooves, configured to align the amplifier assembly 200 with the handle assembly.

[0157] Electrical connector 230 of electrical component 235 is shown at a relatively upper position on the proximal nose 210. Electrical component 235 includes a flexible printed circuit board electrically connected to electrical connector 230 and the outputs of various sensors described herein.

[0158] The distal waveguide 260 is shaped to allow access to the distal region of the distal chamber 262, such that a pressure sensor 269 can be located on the distal waveguide 260, allowing readings of the pressure of the fluid (e.g., saline) present in the distal chamber 262. Any pressure sensor 269 capable of measuring fluid and generating an electrical signal based on such readings can be used. The pressure sensor 269 is integrated into the distal waveguide 260 in any convenient manner, such as via a threaded interface. The pressure sensor 269 is used to sense the pressure within the distal chamber 262, including pressure changes, i.e., pressure changes caused by pressure pulses, and thus senses the pressure transmitted or being transmitted through the catheter interface 264 and catheter assembly 265, ultimately transmitted to the distal balloon operatively connected to the amplifier assembly 200. In other words, the pressure reading obtained by the pressure sensor 269 reflects the pressure applied by the amplifier assembly 200 to, for example, the distal balloon or other tissue-attachment element, and therefore (where applicable) reflects the pressure applied to a lesion proximal to such balloon or other tissue-attachment element. The output of pressure sensor 269 is electrically connected to electrical component 235, such that the readings of pressure sensor 269 can be processed, stored and / or transmitted by electrical component 235 (e.g., via electrical connector 230).

[0159] The amplifier assembly 200 also includes one or more sensors for sensing the position of the diaphragm 270, specifically the degree of translation of the diaphragm 270 between its distal surface 211 and proximal surface 261. Many commonly used sensors are conceivable. Figure 2A In the illustrated embodiment, amplifier 200 includes a Hall sensor for this position sensing, specifically for sensing the position of diaphragm 270. This Hall sensor includes a first magnet 276 integrated into the proximal nose 210 and a second magnet 266 integrated into the distal waveguide 260. These magnets are positioned such that they maintain a fixed distance from each other and are located in fixed positions (if applicable) within the proximal nose 210 and distal waveguide 260. These magnets can be oriented in any convenient orientation relative to magnetic polarity. The Hall sensor further includes an electrical probe 275 present in the central region of diaphragm 270. The electrical probe 275 is electrically connected to electronics 235 via a "pigeon" connector (i.e., a connector with sufficient slack built into its length so that it can move back and forth with diaphragm 270 toward proximal face 261 and distal face 211). This electrical probe can be attached to the diaphragm 270 in any convenient way, such as by adhesive techniques or glues, like epoxy resin or adhesives, as long as the electrical probe 270 moves with the diaphragm 270 and reaches the same extent, the movement being caused by pressure (e.g., pressure pulses or static pressure) applied to the amplifier assembly 200.

[0160] The position of the diaphragm 270 corresponds to the volume (or volume change) of the distal chamber 262, which in turn corresponds to the volume change of the balloon or other tissue-attached element operatively connected to the amplifier assembly 200 via the catheter interface 264 and the catheter assembly 265. This volume change of the balloon or other tissue-attached element provides information, for example, related to lesion treatment, such as potentially indicating changes in balloon volume when the same or different pressures are applied to the balloon, i.e., information related to vascular compliance. The proximal nose 210 includes a first container for holding a first magnet in a fixed position. The distal waveguide 260 includes a second container for holding a second magnet in a fixed position. Such containers can include any convenient techniques or mechanisms for holding the magnet in a fixed position, such as adhesives, glues, mechanical configurations, etc. For example, the first and second containers include compression ribs, meaning protrusions (i.e., ribs) surrounding the outer periphery of the container, between which the magnet is positioned, thereby compressing (i.e., crushing) these ribs, such that the magnet is tensioned and held between these ribs.

[0161] In one embodiment, the position sensor may be configured such that a magnet may be present in the central region of the diaphragm 270, and one or more electrical probes may be located at fixed positions on the distal waveguide 260 and / or the proximal nose 210. This configuration may represent easier manufacturing or a longer lifespan for the amplifier assembly 200 because the magnet present on the diaphragm 270 does not require an electrical connection to the electronics assembly 235.

[0162] A housing 290 is present around the external periphery of the proximal nose 210, the distal waveguide 260, and the diaphragm 270, such that these components are substantially enclosed by the housing 290. The housing 290 is shaped to expose the proximal interface 220 for mating with the handle assembly and to expose the output of the conduit interface 264, such that the output of the amplifier assembly 200 is transmitted to the conduit assembly 265.

[0163] Figure 3A -B depicts the proximal nose of an amplifier assembly according to an embodiment of the present invention. Figure 3A In Figure B, elements with the same or similar reference numerals have the same or similar features as the corresponding elements in Figures 1-2, unless otherwise explicitly stated.

[0164] Figure 3A The amplifier components (e.g.) are described Figure 1B The amplifier assembly 100 shown or Figure 2A An external view of the proximal nose 310 of the amplifier assembly 200 shown. The proximal side of the proximal nose 310 is shown on the right side of the figure, and this side of the proximal nose includes a chamfered edge circumference. This side of the proximal nose 310 is chamfered to facilitate alignment with the handle assembly and to form an operable connection. A hole 368 is included for inserting a pin, such as a metal (e.g., steel) pin, i.e., a retaining pin, such as... Figure 2AThe pin 267 shown is used to hold the proximal nose 310 together with the distal waveguide 260 (e.g., to hold the proximal nose 210 against the distal waveguide 260 and seal the diaphragm 270 between the proximal nose 210 and the distal waveguide 260; e.g., to compress the diaphragm 270 between the proximal nose 210 and the distal waveguide 260).

[0165] The proximal side or proximal region of the proximal nose 310 (shown on the right side of the figure) is configured to substantially cover or close the proximal interface 320 including the high-voltage connector 323 (i.e., the high-voltage connector 323 does not protrude or extend beyond the proximal nose 310), thus protecting these components from accidental damage or wear.

[0166] Figure 3B A cross-section, i.e., sectional view, of the proximal nose 310 is depicted. The distal face 311 of the proximal nose 310 defines a proximal chamber 312 (which is sealed when a diaphragm is present). The shape of the distal face 311, i.e., the bend, is selected to correspond to a fold or pleat of the diaphragm, such that the diaphragm abuts against the distal face 311 at its proximal position. The proximal interface 320 includes a high-voltage connector 323 fluidly connected to the proximal chamber 312, having an O-ring groove 325 for accommodating an O-ring that seals the interior 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, such that energy received via the high-voltage connector 323 (e.g., pressure pulses or static pressure, such as pneumatic pressure pulses or static pneumatic pressure) is transmitted to the proximal chamber 312 and a diaphragm present in and sealing the distal region of the proximal chamber 312. The high-voltage connector 323 is made of metal integrated into a material (e.g., plastic) of the proximal nose 310.

[0167] The proximal nose portion 310 includes a first magnet compartment or container 378 for receiving a first magnet (not shown), the first magnet including a portion of a position sensor (e.g., a Hall sensor) for sensing the position of the diaphragm as it translates between the distal end face 311 of the proximal chamber 312 and the proximal end face of the distal chamber. The first magnet compartment or container 378 includes clamping 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 container 378 by squeezing or crushing the magnet therebetween.

[0168] Figure 4A -B depicts the distal waveguide of an amplifier assembly according to an embodiment of the present invention. Figure 4A In Figure B, elements with the same or similar reference numerals have the same or similar features as the corresponding elements in Figures 1-3, unless otherwise explicitly stated.

[0169] Figure 4A The amplifier components (e.g.) are described Figure 1B The amplifier assembly 100 shown or Figure 2A An external view of the distal waveguide 260 of the amplifier assembly 200 shown. 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 is shaped to mate with the diaphragm.

[0170] The proximal periphery includes a rounded chamfer or shoulder 463, which is configured to correspond with a protrusion on the periphery of the diaphragm (e.g., Figure 2A The elements 275 of the diaphragm 270 are mated so that the diaphragm can be sealed between the proximal nose and the distal waveguide 460, thereby sealing the distal chamber 462.

[0171] The remote waveguide 460 is shaped to include a pressure sensor interface 471, which accommodates a pressure sensor (e.g., Figure 2A (Pressure sensor 269). This interface 471 allows the pressure sensor to be integrated into the distal waveguide 460 in any convenient manner, such as via a threaded interface. The pressure sensor interface 471 is fluidly connected to the output of the distal chamber 462, such that the pressure sensor located in the interface 471 can sense the pressure within the distal chamber 462, including pressure changes, i.e., pressure changes caused by pressure pulses. Therefore, this pressure reading corresponds to the pressure transmitted through the conduit interface 464, ultimately transmitted to the distal balloon operatively connected to the distal waveguide 460. The pressure sensor interface 471 is positioned such that the pressure sensor present in this interface can be electrically connected to the electrical components of the amplifier assembly.

[0172] The catheter interface 464 includes any convenient mechanism for attaching the catheter to receive output energy (e.g., pressure pulses or static pressure, such as the pressure of a fluid like saline) transmitted from the distal chamber 462 to the catheter interface 464. Such a mechanism may include, for example, a Luer lock or a floating Luer lock. Figure 4A In the diagram, conduit interface 464 is shown as including threads for threaded mating with the output conduit assembly.

[0173] The shape of the far-end waveguide 460 includes a receiving pin (i.e., a retaining pin, such as a steel pin). Figure 2A The circular surface 472 of the pin 267 shown, through which the pin passes (as shown) Figure 3A -B indicates hole 368) which crosses the proximal nose (as shown in Figure 368) Figure 2A The width of the proximal nose 210 shown is such that the distal waveguide 460 is held against the proximal nose and the diaphragm is sealed therebetween.

[0174] Figure 4BA cross-sectional view of the distal waveguide 460 is depicted. The proximal face 461 of the distal waveguide 460, together with the diaphragm, defines a distal chamber 462. The proximal face 461 is shaped such that folds or wrinkles of the diaphragm can unfold to meet the surface of the proximal face 461 (i.e., at the farthest position of such diaphragm) without generating strain on such diaphragm.

[0175] The second magnet compartment or container 478 is located in the distal region of the distal chamber 461 and is shaped to accommodate a magnet (not shown) that includes part of a position sensor (e.g., a Hall sensor) for sensing the position of the diaphragm as it translates between the proximal face 461 of the distal chamber 462 and the distal face of the proximal chamber. The second magnet compartment or container 478 includes clamping ribs 477 (i.e., protrusions extending outward from the surface of the second magnet compartment or container 478) for holding the magnet in a fixed position within the second magnet compartment or container 478 by squeezing or crushing the magnet therebetween.

[0176] Figure 5A -C depicts a schematic diagram of the diaphragm of an amplifier assembly according to an embodiment of the present invention. Figure 5A In Figures C, elements with the same or similar reference numerals have the same or similar features as the corresponding elements in Figures 1-4, unless otherwise explicitly stated.

[0177] Figure 5A A diaphragm 570 is depicted, showing its distal surface. The term "distal surface" refers to the side of the diaphragm 570 facing the distal region of the amplifier assembly when the diaphragm 570 is mounted within the amplifier assembly. This distal surface faces and can contact the proximal surface of the distal chamber (e.g., ...). Figure 4B The proximal end face 461 of the distal chamber 462 shown. Figure 5B Diaphragm 570 is depicted, and a cross-sectional view of diaphragm 570 is shown. Figure 5C A diaphragm 570 is depicted, showing its proximal surface. The term "proximal surface" refers to the side of the diaphragm 570 facing the proximal region of the amplifier assembly when the diaphragm 570 is mounted in the amplifier assembly. This proximal surface faces and can contact the distal surface of the proximal nose (e.g., Figure 3B The distal end face 311 of the proximal chamber 462 shown.

[0178] The diaphragm 570 includes a fold 573. The fold 573 is shaped such that, when mounted in an amplifier assembly between the proximal nose and the distal waveguide, the diaphragm 570 can be displaced between the distal face of the proximal nose and the proximal face of the distal waveguide by unfolding the fold 573, thereby preventing strain on the diaphragm 570, or preventing substantial strain, i.e., preventing strain or tension on the diaphragm material, or preventing stretching or resistance to the diaphragm material, or preventing stress on the diaphragm material. In other words, the diaphragm 570 unfolds itself, taking on a new shape, and ultimately conforms to the distal face of the proximal nose at its closest point and to the proximal face of the distal waveguide at its furthest point. The diaphragm 570 includes circumferential protrusions 575 in its outer peripheral region. A protrusion 575 is present on the diaphragm 570 to enable the diaphragm 570 to maintain its seal relative to the proximal and distal chambers, even during translation between the distal face of the proximal nose and the proximal face of the distal waveguide. The protrusion 575 is shaped to, for example... Figure 4A -B shows the shoulder or chamfer of the far-end waveguide at 463.

[0179] Figure 6A -C depicts a schematic diagram of the housing of an amplifier assembly according to an embodiment of the present invention. Figure 6A In Figures C, elements with the same or similar reference numerals have the same or similar features as the corresponding elements in Figures 1-5, unless otherwise explicitly stated.

[0180] Figure 6A The housing 690 is depicted in 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 when viewed from the bottom upwards. Figure 6B A cross-sectional view of housing 690 is depicted, showing the shape of the internal cavity 691 of housing 690. The internal cavity 691 is shaped such that housing 690 can substantially cover the distal waveguide, diaphragm, and proximal nose, as well as other components such as electrical assemblies. Figure 6C An isometric view of housing 690 is depicted.

[0181] The housing 690 provides a durable cover for the internal components of the amplifier assembly housed therein. The housing 690 is shaped to include a flexible arm 693 for operatively connecting the amplifier assembly enclosed within the housing 690 to a handle assembly. The exterior of the housing 690 is formed with gripping sections 695 having grooves, treads, or other shapes or textures to facilitate manual holding and / or manipulation of the amplifier assembly housed within the housing 690 without causing it to slide or rotate in an undesirable or accidental manner.

[0182] One embodiment of the amplifier assembly can be according to Figure 7AThe assembly steps 1 through 12 shown illustrate the interconnections between the components of this embodiment. Another amplifier assembly can be assembled according to... Figure 7B The steps 1 to 13 shown illustrate the assembly, and these assembly instructions demonstrate the interconnection between the components of this embodiment.

[0183] Handle component:

[0184] As described above, a handle assembly for controllably transferring energy is provided. In an embodiment, the handle assembly controls the transfer of a first pulse of energy to be transferred to an amplifier assembly. Figures 8A-8F As shown, aspects of the handle assembly 800 include: a connector assembly 850 operatively connected to an energy source; a manifold 830 operatively connected to the energy source via the connector assembly 850 and configured to controllably transfer energy to a remote interface 810; and a remote interface 810 operatively connected to the output of the manifold 830 and configured to transfer energy received from the manifold 830. In an embodiment, the handle assembly is configured to be operatively connected to an amplifier assembly, such as those described herein, and to transfer energy from the energy source to the amplifier assembly.

[0185] Embodiments of the handle assembly are configured to operatively interface with an amplifier assembly (such as the embodiment of the amplifier assembly described herein). In one embodiment, the handle assembly 800 is configured to releasably engage with the amplifier assembly 200, such that the two assemblies form an operative connection. When engaged and operated, the handle assembly delivers a first energy to the amplifier assembly. This operative connection may, for example, be configured to facilitate energy transfer from the handle assembly to the amplifier assembly. This operative connection may also, for example, be configured to facilitate certain electrical connections between the handle assembly 800 and the amplifier assembly 200, such as power connections, data connections, control connections, or common ground connections. In one embodiment, the handle assembly 800 may include alignment features, such as bonding elements 815, or a particular shape, such as an asymmetrical shape, that allows the handle assembly and the amplifier assembly to releasably engage with each other only in a single designated orientation (i.e., an orientation that aligns, for example, the high-voltage connector 223 of the amplifier assembly 200 with the hole 820 of the handle assembly 800), such that energy can be safely transferred from the handle assembly 800 to the amplifier assembly 200. In some cases, this alignment feature further ensures the interconnection of certain electrical connectors on the handle assembly with certain electrical connectors on the amplifier, as described herein.

[0186] In one embodiment, the handle assembly includes a distal interface configured to operatively mate with the proximal nose of the amplifier assembly. In some cases, alignment features of the distal interface are configured to mate with corresponding alignment features of the proximal nose of the amplifier assembly. For example, the alignment features of the distal interface may include a bonding surface, and the proximal nose of the amplifier assembly includes a corresponding bonding surface.

[0187] Handle components can be configured as reusable or disposable as needed. In cases where the handle component (or aspects thereof) is reusable and may come into contact with the patient area, such components can be configured to be covered in a disposable sterile sleeve or bag, allowing the handle component to be used without contaminating the sterile area of ​​the operating room.

[0188] Remote interface:

[0189] Embodiments of the handle assembly are configured to be operatively connected to an amplifier assembly (such as the amplifier assembly described herein). Embodiments of the handle assembly and amplifier assembly are configured such that the two components can be manually aligned and connected, i.e., by hand or a gloved hand (as may be required in the operating environment). In embodiments, the distal interface of the handle assembly includes one or more alignment features configured to achieve such alignment and operative connection with the amplifier assembly. In some cases, the alignment features include bonding protrusions configured to align the handle assembly with an external component (e.g., the amplifier assembly), such as the bonding surface or keyway of the amplifier assembly.

[0190] Embodiments of the remote interface are configured to operatively mate with the proximal nose of the amplifier assembly. When present, alignment features of the remote interface can be configured to mate with corresponding alignment features of the proximal nose of the amplifier assembly. In embodiments, alignment features of the handle assembly and corresponding alignment features of the amplifier assembly can be used to align the electrical connectors of the electrical components of the handle assembly with the electrical connectors of the electrical components of the amplifier assembly.

[0191] In embodiments, the distal interface of the handle assembly (which may be referred to as the receiving portion of the handle assembly) holds and secures the amplifier assembly during use and prevents improper use of the assembly. The distal interface can be configured to mate with the proximal interface of the proximal nose of the amplifier assembly using a keyway as described herein, which controls the rotational, axial, and radial position of the amplifier assembly relative to the distal interface of the handle assembly. In some cases, the distal interface of the handle assembly comprises a generally circular keyway shape with a slotted notch. However, other configurations can be employed to control the position and orientation of the handle assembly relative to the amplifier assembly.

[0192] In some embodiments, a key present 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 metal, such as steel, stainless steel, aluminum, brass, or other metals, as required. When present, the key on the distal interface may be substantially straight, with uniform (no draft) walls or sides. Embodiments of the corresponding proximal interface of the amplifier assembly may be injection molded, a process configured to produce walls with draft angles. This drafting serves to guide the key of the distal interface of the handle assembly into a locating keyway in the proximal interface of the amplifier assembly, which ensures alignment of the amplifier assembly when inserted into the distal interface of the handle assembly.

[0193] In other embodiments, however, different bonding mechanisms may be used on the handle assembly and the corresponding amplifier assembly, for example, 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 alignment features within the keyway that receive corresponding features on the key of the amplifier assembly.

[0194] In embodiments, the distal interface of the handle assembly can be configured to facilitate docking with the amplifier assembly. In embodiments, openings (e.g., two, three, four, five, or more openings) on the distal interface can be configured to receive, as needed, mating and locking arms or snap-fit ​​or bonding interfaces of the amplifier assembly. These openings can be through-holes or blind holes, and can be circular or elliptical. These openings can have recesses that compress the snap-fit ​​or snap-fit ​​or flexible arm of the amplifier assembly during insertion of the amplifier assembly into the receiving portion. The edges of these openings can retain the snap-fit ​​or snap-fit ​​or flexible arm when operating the handle assembly and the amplifier assembly (e.g., during pulsed energy transfer). In some embodiments, maintaining the orientation and operable connection of the handle assembly relative to the amplifier assembly can include one or more screws, mechanical, magnetic, or electromechanical latches, push-in connectors, etc., which may be present on the distal interface of the handle assembly.

[0195] As described above, in this embodiment, the distal interface of the handle assembly is configured to transmit energy received from the manifold. In this embodiment, the distal interface is configured to transfer this energy from the handle assembly to an amplifier assembly operatively connected thereto. In some embodiments, the handle assembly includes an outlet port for transferring 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 an aperture configured to mate with the amplifier assembly, for example, for receiving and abutting with a high-voltage connector (i.e., the connector nose of the high-voltage connector) of the amplifier assembly. This aperture may include an outlet port of the manifold (e.g., the output port of an oscillator (e.g., a solenoid valve) of the manifold) and may be appropriately sized to form a seal with, for example, the connector nose of a high-voltage connector (e.g., an O-ring present on the connector nose of the high-voltage connector). In one embodiment, partly to prevent misalignment between the aperture 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 lead to, for example, O-ring eccentricity and / or leakage of high-pressure fluid (e.g., gas) during treatment—the distal interface and its alignment features (e.g., alignment keys) are used to align the amplifier assembly such that the desired alignment is achieved when the connector nose of the high-pressure connector enters the aperture. In other embodiments, the aperture is configured only to form a seal with the connector nose of the high-pressure connector of the amplifier assembly, rather than to position the proximal connector within a receptacle.

[0196] Connector assembly

[0197] As described above, the handle assembly of the present invention includes a connector assembly operatively connected to an energy source. That is, the connector assembly is configured to receive energy from the energy source and transfer such energy within the handle assembly to a manifold. In embodiments, the connector assembly is operatively connected to a manifold of the handle assembly. For example, the manifold may be operatively connected to the energy source via an input connector of the connector assembly. In some embodiments, the connector assembly includes input and exhaust connectors, wherein the input connector is operatively connected to the energy source and the exhaust connector is configured to discharge energy from the energy source. In one embodiment, the connector assembly includes pipes, such as an input pipe and an exhaust pipe. When present, the input pipe may be operatively connected to the energy source, and the exhaust pipe may be configured to discharge energy from the energy source.

[0198] In embodiments, the handle assembly includes a connector assembly that includes an inlet port. In some cases, the connector assembly (or its inlet port) can receive energy (e.g., high-pressure gas) from an energy source via a tube or hose (in some cases with high-pressure fittings, as known in the art). The connector assembly (or its inlet port) can be connected to one or more pressure sensors and solenoid valves. To simplify the manufacturing process involved in the handle assembly embodiments and reduce the need for, for example, plug fittings, an orifice can be created between the pressure sensor (if present), the connector assembly (or its inlet port), and the manifold's oscillator (e.g., a solenoid valve) through a single hole (in a region referred to as the pressure sensor port area). Such an inlet port can include a filter, such as a particulate filter, to minimize the possibility of particles entering the manifold or its oscillator or fluid passage (i.e., gas passage).

[0199] In some cases, the handle assembly is configured such that the connector 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, where present, the orifice of the handle assembly) in order to minimize the number of sharp turns that the high-pressure gas must undergo, which reduces the energy stored in the fluid (e.g., gas).

[0200] In one embodiment, the connector assembly includes a relatively long flexible tube configured to interface with an energy source such that it can carry high-pressure fluid (e.g., high-pressure gas) to and / or carry exhaust gas out of the handle assembly and / or carry electrical signals and / or communications to and from the handle assembly and / or deliver power to the handle assembly. The connector assembly may be configured to have protective seals, for example, around the exterior of one side of the connector assembly, to protect it from external abrasion in the operating environment.

[0201] Manifold:

[0202] The handle assembly of the present invention further includes a manifold. In an embodiment, the manifold is operatively connected to an energy source via a connector assembly and is configured to controllably deliver energy to a distal interface of the handle assembly. In an embodiment, the manifold is configured to receive a high-pressure fluid, such as high-pressure gas, and controllably deliver such high-pressure fluid to the distal interface of the handle assembly.

[0203] In some embodiments, the manifold includes an oscillator operatively connected to an energy source. When present, the oscillator can be configured to deliver energy through the manifold in a first position and discharge energy in a second position. That is, the oscillator can be configured to deliver energy pulses to a remote interface of the handle assembly.

[0204] In some cases, a manifold can receive energy from one or more energy sources (e.g., one or more console units comprising 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 the oscillators in the manifold. In other cases, a single energy source can deliver energy to one or more oscillators. In still other cases, one or more energy sources can deliver energy to a single oscillator, for example, such that the energy from one or more energy sources is combined in a single oscillator.

[0205] In embodiments, the energy transmitted to the oscillator comprises regulated or unregulated pressurized fluid. The oscillator can be actuated to output pulsating and / or static pressure outputs. In some embodiments where the energy transmitted by the energy source is regulated or unregulated pressurized fluid, the oscillator may include a solenoid valve. Such a solenoid valve may include, for example, a two-position, three-position normally closed solenoid valve. In this case, the solenoid valve is configured to receive high-pressure regulated or unregulated fluid. Such a solenoid valve may be configured to have two modes, an "on" mode and a "off" mode. Such a solenoid valve may be configured to have three ports: a port operably connected to the high-pressure regulated or unregulated fluid (i.e., the input port), a port ultimately operably connected to the amplifier assembly (i.e., via a remote interface), and an exhaust port (i.e., a second output port). The solenoid valve may be configured such that when open (i.e., in the "on" mode), the valve allows the high-pressure regulated or unregulated fluid to be transmitted, i.e., downstream in the handle assembly, for example, to the amplifier assembly operably connected to the handle assembly. The valve can be further configured such that when closed (i.e., in "closed" mode), the solenoid valve changes (i.e. reverses) the connected port, causing venting (e.g., venting to the atmosphere or vacuum) to the distal end of the valve. In other words, in "closed" mode, the first output port can be connected to the second output port to discharge high-pressure fluid present on the distal end of the solenoid valve.

[0206] In some embodiments, the frequency and / or duty cycle of the oscillator can be adjusted to produce a desired output, such as an appropriate output for treatment, and an appropriate output for an amplifier assembly, including, for example, a tissue-attaching element (e.g., a distal balloon) operatively connected thereto. In various embodiments, one or more oscillators in the manifold can be configured to oscillate at one or more frequencies and / or duty cycles. In some cases, an oscillator configured, for example, to deliver pulsatile endovascular lithotripsy to cardiovascular tissue can be configured to oscillate at a frequency between 0 and 50 Hz, such as 1-10 Hz, 10-20 Hz, 21-30 Hz, 31-40 Hz, or 41-50 Hz, and a duty cycle between 10% and 90%, such as 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90%. In cases where the oscillator is configured to use fluid pressure to deliver pulsating pressure pulses for treatment involving achieving vascular perfusion of cardiovascular tissue, the oscillator may oscillate at a frequency between 0.25 Hz and 5 Hz, such as 1 Hz, 2 Hz, 3 Hz, 4 Hz, or 5 Hz, and a duty cycle between 10% and 90%, such as 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90%. In cases where the oscillator is configured to deliver pulsed energy including optical or high-voltage sources, the oscillator can oscillate at frequencies from 0.1 Hz to 1 GHz, such as 1 Hz, 2 Hz, 3 Hz, 4 Hz, 5 Hz, or higher, and at duty cycles between 0.0001% and 90%, such as 0.001%, 0.01%, 0.1%, 1%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90%.

[0207] In some embodiments, the output from the manifold oscillator, or, in embodiments having more than one oscillator, the output from each oscillator, can be transmitted to one or more locations. In other embodiments including more than one oscillator, the oscillators can be synchronized with each other, for example, such that the pulsating energy transmitted from each oscillator is synchronized as needed, such as in amplitude, frequency, phase, duty cycle, etc. In other embodiments, the oscillators can be synchronized with external factors or systems or sensors, for example, with the results of an electrocardiogram (ECG), or can be adjusted based on feedback from other aspects of the handpiece assembly, the amplifier assembly, or other aspects of the system in which such components are part (e.g., volume or pressure measurements, such as volume or pressure measurements detected by sensors present on tissue-attached elements (e.g., distal balloons) operably connected to the amplifier assembly).

[0208] As described above, when present, the oscillator can be a solenoid valve, and such a solenoid valve can be attached to other aspects of the handle assembly in any convenient configuration. In some cases, the solenoid valve (sometimes referred to as a solenoid valve) can be a normally closed solenoid valve (i.e., a solenoid valve configured to open the outlet port to the exhaust port for venting when in the "closed" position, and to pressurize the outlet port (e.g., an orifice of the distal interface) when in the "open" or "open" position). In some cases, the solenoid valve is configured to employ linear movement of a plunger when switching between the "open" and "closed" positions. In some cases, this linear movement is achieved by the action of a spring and a solenoid coil. In other embodiments, lateral or rotational movement of the plunger produces the opening and closing of the solenoid valve (i.e., the opening and closing of the solenoid valve).

[0209] In embodiments, aspects of the handle assembly, including, for example, a manifold, can be shaped to fit and be secured within a surrounding housing (i.e., the casing), as described below. Embodiments of the handle assembly, including, for example, a manifold, can be machined from a solid metal block (e.g., stainless steel, aluminum, brass, or other metals as desired), or cast using processes such as lost-wax casting (using materials such as brass (or other materials as desired)), or can be injection molded from a thermoplastic material (e.g., nylon-12, PEEK, or ABS, which may be glass or fiber-filled).

[0210] Electrical components:

[0211] Embodiments of the handle assembly further include electrical components (also referred to as electronic components). The electrical components may be operatively connected to any other aspect of the handle assembly, such as a manifold, and / or configured to be operatively connected to an external device. The electrical components may be configured to perform various functions as needed, including, for example, powering various sensors internal or external to the handle assembly, controlling such sensors, receiving data from such sensors, recording and / or transmitting (e.g., wirelessly) such data to another location, controlling various aspects of the handle assembly or aspects external to the handle assembly, and / or storing information about the handle assembly or an amplifier assembly to which it is connected, or other aspects of the system to which the handle assembly is connected.

[0212] In some cases, the electrical component includes a controller programmed to perform self-test and / or self-diagnostic procedures to verify the safety of the amplifier assembly, for example. In embodiments, the electrical component is a flexible printed circuit board and is configured to perform several functions, including, for example, creating electrical connections to the amplifier assembly and / or storing or retrieving such information from memory for catheters, balloons, and / or other treatment-specific information.

[0213] In this embodiment, the electrical component is configured to control an oscillator. When configured this way, the electrical component can be configured to move the oscillator from a first position to a second position, such as from an "off" position to an "on" position. In some cases, the electrical component is configured to interface with external components as needed, such as an amplifier assembly or one or more power sources, a user console, or other external components. In some cases, the electrical component is electrically connected to multiple pin connectors; for example, a handle assembly may include pin connectors configured to interface with a board connector of an amplifier assembly.

[0214] In some embodiments, the handle assembly includes an electronics compartment configured to house electronic components (or aspects thereof, such as a printed circuit board). This electronics compartment can be configured such that electrical contacts (e.g., pins, sliding contacts, rolling contacts, flexible contacts, etc., configured for electrical contact, which may be present on the printed circuit board) are positioned and / or oriented and / or horizontal relative to an external component (e.g., an amplifier assembly) with which the contacts establish a connection. In embodiments, a seal can be created between the aspect of the electronic component (e.g., the printed circuit board) and the electronics compartment. This seal can be configured to limit (partially or completely) the amount of fluid that can enter the handle assembly.

[0215] In embodiments, the electrical components include multiple electrical connectors, comparators, logic gates, and power management areas, and these may be at least partially present on, for example, a printed circuit board. When present on a printed circuit board, the connectors on the printed circuit board may be oriented within the handle assembly such that the connectors are positioned at desired locations within the handle assembly or its electronics compartment, for example, to establish an operative connection with an amplifier assembly. In some cases, the electronic components or their printed circuit boards include one or more protective features configured to protect connectors mating with and from external components, such as amplifier assemblies that slide into and out of a distal interface of the handle assembly (or other receptacle of the handle assembly, as applicable). In embodiments, electrical components 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 the light-emitting diode, oscillator (e.g., solenoid valve), and / or amplifier assembly; (3) comparing sensor readings, for example, comparing a handle pressure sensor reading with the maximum pressure assigned to the amplifier assembly; (4) detecting the detection of a position sensor (e.g., a Hall sensor) limit switch (i.e., as may be present on the amplifier assembly); and / or (5) safety limit detection and power cut-off.

[0216] As described herein, embodiments of the handle assembly include multiple electrical connectors. These connectors can be configured to mate with the handle assembly (as described herein) and to transmit any desired data or control signals, or to transmit power or connect to a common ground, in each case between such components. In some cases, the multiple connectors present on the handle assembly are pin connectors (also known as ball connectors). A pin connector is a cylinder made of a conductive material (e.g., any convenient metal) operably connected to a spring that longitudinally pushes the cylinder toward, for example, a complementary connector on an amplifier assembly. The spring or other biasing element is configured to ensure a consistent physical connection between the electrical connectors, and thus maintain the electrical connection. In embodiments, the complementary connector of the amplifier assembly includes a plate connector, i.e., a planar surface comprising a conductive material (e.g., any convenient metal). In embodiments, the ends of the pin connectors of the handle assembly are pushed to physically and thus electrically connect to the corresponding plate connectors of the amplifier assembly. Embodiments of the handle assembly and amplifier assembly include any number of electrical connectors, such as any number of pin connectors or board connectors (as the case may be), such as one or more, such as five or more, such as ten or more, such as twenty or more, such as 2, 5, 10, 12, 16, 32 or 64 or more pins.

[0217] When present, the pin connectors of the handle assembly can be arranged substantially in a V-shape. In this embodiment, the apex or tip of the V-shape can be electrically connected to ground. When this arrangement is used for operatively connecting to an amplifier assembly including a board connector, the board connector can be arranged to receive the V-shape of the pin connector and configured accordingly. In this case, the pins and boards can be arranged such that when the amplifier assembly is operatively connected to the handle assembly, the electrical connection to ground is the initial electrical connection established. For example, when the pin connectors are connected in a V-shape and have a ground connection at the apex or tip of the V, the first electrical connection established when the handle assembly is operatively connected to the amplifier assembly is a ground connection. This is because the position of the connector located at the apex or tip of the V-shape arrangement makes it closest to the amplifier assembly when the two assemblies are operatively connected (i.e., the pin is located at the farthest end of the pins). In this case, the pins and boards are arranged such that when the amplifier assembly is operatively connected to the handle assembly, an electrical connection to ground is established before other electrical connections are established. Similarly, in the embodiments, multiple pins and plates are arranged such that when the amplifier assembly is disconnected from the handle assembly, the electrical connection to ground is the last electrical connection to be disconnected. That is, in the embodiments, multiple pins and plates are arranged such that when the amplifier assembly is disconnected from the handle assembly, the electrical connection to ground is disconnected after other electrical connections are disconnected. This arrangement improves device safety because it reduces the possibility of static buildup or accidental circuit closure, since the ground connection remains available until other electrical connections between the handle assembly and the amplifier assembly are disconnected.

[0218] System check:

[0219] In embodiments, the handle assembly is configured to perform one or more system self-tests. In some cases, the system self-test is performed before activating the oscillator. For example, when the user initiates engagement or activates the oscillator, the handle assembly is configured to automatically perform a self-test first. System self-tests of interest include, for example, detecting leaks from the energy source; for example, determining whether there are leaks in one or more components inside or outside the handle assembly. Embodiments of the handle assembly are configured to perform system checks associated with confirming the presence of correct or expected voltage and current; confirming that the voltage or current is within acceptable ranges; confirming the presence of electrical grounding; confirming that the pre-programmed memory chip response is as expected or specified; confirming zero or maximum cycle count confirmation; confirming that the pressure sensor feedback is as expected or specified; confirming that the occurrence of changes in displacement and / or voltage and / or current (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 or removed to the diaphragm). In embodiments, the handle assembly may be configured to perform system checks independently, or it may be configured to be combined with an amplifier assembly to perform or facilitate such system checks, the amplifier assembly itself being configured to perform or facilitate such system checks. In some embodiments, the amplifier assembly may be configured to perform system checks independently and transmit the results of such system tests to the handle assembly or other aspects of the system, such as an operatively connected computing device or computer tablet.

[0220] As described above, embodiments of the handle assembly are configured to releasably engage with embodiments of the amplifier assembly, such that the handle assembly is operatively connected to the amplifier assembly. This operative connection allows energy to be transferred from the handle assembly to the amplifier assembly. In some cases, this operative connection further allows electrical connection between the handle assembly and the amplifier assembly, i.e., engagement 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 proper connection of the system and to prevent operation when the handle assembly and the amplifier assembly are not properly connected, or one or more other safety aspects may be configured to prevent certain behaviors of the handle assembly and / or the amplifier assembly and / or other aspects of the system of the present invention. In particular, such safety aspects may be configured to prevent operation of the handle assembly and / or the amplifier assembly when the handle assembly is not releasably engaged or operatively connected to the amplifier assembly, i.e., not connected in a specified orientation that enables safe energy transfer from the handle assembly to the amplifier assembly. Such safety features may include, for example, an interlocking mechanism. In embodiments, the handle assembly may include an interlocking mechanism configured such that the handle assembly cannot transfer energy when the amplifier assembly is not properly connected or attached to the handle assembly. When present, this interlock mechanism can be configured to prevent the handle assembly embodiment from transmitting energy to the amplifier assembly, for example, if the amplifier assembly appears to be malfunctioning. For instance, the handle assembly can be configured to expect a specified output from a displacement sensor (e.g., a Hall sensor) of the diaphragm attached to the amplifier assembly when a specified amount of energy is transmitted by the handle assembly. When this specified displacement of the diaphragm does not occur, the handle assembly can be configured to indicate an error state and stop transmitting energy to the amplifier assembly.

[0221] In some embodiments, such an interlocking mechanism is configured such that energy cannot be 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 broken, or when the common ground is not connected or is unavailable.

[0222] In other embodiments, the handle assembly includes an interlocking mechanism comprising directional elements, such as bonding elements, configured such that the amplifier assembly and the handle assembly are releasably engaged with each other only in a designated orientation that facilitates connections between, for example, hydraulic systems (e.g., pressurized gas) and electrical connections.

[0223] user interface:

[0224] The handle assembly may include user interface features, for example, for use by an operator of the handle assembly and / or a system in which the handle assembly is part. These features may include input and / or output features; that is, features for receiving or transmitting information to or from a user (e.g., an operator).

[0225] In some cases, the user interface of the handpiece assembly includes input devices or operator controls to facilitate treatment, such as one or more buttons, i.e., operator controls. For example, the user interface of the handpiece assembly may include operator controls for activating the oscillator of the handpiece assembly. When present, the input device may include a single button or multiple buttons configured to receive / read / detect user (e.g., operator) feedback or control information. Input features, such as one or more buttons, may be located in any convenient location outside the handpiece assembly, for example, in a location chosen to facilitate the correct use of such input features, or in a hard-to-reach location (e.g., buttons for uncommon situations and / or to avoid accidental button presses).

[0226] In embodiments, the user interface of the handle assembly includes output devices, such as one or more lights, such as LED lights. Embodiments of the output devices may include any visual or tactile element to convey information to an operator, such as any type of lighting or light, such as LED lights. In embodiments, the lights, such as LEDs, may be used to convey information to a user (e.g., an operator), or to illuminate (i.e., highlight) certain portions of the amplifier assembly, or otherwise convey information about the state of the handle assembly or the amplifier assembly or other aspects of the system in which the handle assembly is part. In some embodiments, as described above, one or more lights (e.g., LEDs) may be integrated into one or more input devices (e.g., buttons). In other embodiments, one or more lights (e.g., LEDs) may be multi-colored (i.e., different current inputs produce different colors). When different colored lights are used, the different colors can be used to provide information to a user (e.g., an operator), such as indicating various conditions or information. In other embodiments, one or more lights may emit various colors to indicate various conditions or information, and / or one or more lights (e.g., light-emitting diodes) may be integrated into the remote interface of the handle assembly and / or into an aspect of the amplifier assembly; for example, the handle assembly and the amplifier assembly may include lights configured for use in conjunction with the two components for orientation or positioning relative to each other or for signaling the correct connection of operation.

[0227] case:

[0228] Embodiments of the handle assembly also include a housing in which the manifold is located, and when present, other aspects of the handle assembly allow different components of the handle assembly to reside within a single housing. This housing can substantially cover the manifold and other components of the handle assembly as needed. In embodiments, the housing is configured to cover and protect the components housed therein, i.e., to protect the internal components from environmental exposure and / or abrasion caused by the introduction of foreign objects. While the form of the housing can vary, in some cases, the housing comprises one or more snap-fit ​​housings configured to substantially enclose the manifold and other components of the handle assembly as needed.

[0229] In one embodiment, the housing includes a clamshell shape, configured to close the manifold and other aspects as needed, and to provide mechanical, electromagnetic, electrical, debris, and fluid protection for components within the housing of the handle assembly.

[0230] In one embodiment, the housing may be configured to provide a unit configured for handheld use. In this case, the handheld component, such as a handheld handle assembly, is designed to be held and operated by a single adult hand. In another embodiment, the housing may also be configured to improve the grip of a user (e.g., an operator).

[0231] In other embodiments, the housing is configured to act as a stress reliever to ensure that the connection point between the handle and the connector assembly, or, for example, elements of the connector assembly configured to operatively connect the handle assembly and an energy source, are not damaged.

[0232] In some cases, the housing may be injection molded from rigid, high-impact thermoplastic to prevent damage to the handle assembly or its internal components.

[0233] The housing can be configured to hold it in a specific "original" position. The housing may include one or more features for storing the handle assembly when not in use. For example, in some embodiments, the handle assembly may include one or more features for storing the handle assembly in a slot, such as on a console to which the handle assembly is attached, 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, wherein a ferromagnetic plate is integrated into the handle assembly housing, and a corresponding magnetic plate and a shaped slot are integrated into a positioning feature. When such a handle assembly embodiment and such a storage feature are in close contact, the magnetic plate and the slot align the handle assembly and / or its housing in its proper position and hold the handle assembly in place when not in use.

[0234] As described herein, the housing and / or the distal interface and / or other aspects of the handle assembly may be configured to facilitate mating with the amplifier assembly. In embodiments, 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 configured to receive mating and locking arms or snap-fit ​​or other elements of the amplifier assembly's mating and locking interface, as appropriate. These openings may be through-holes or blind holes, and may be circular or elliptical. These openings may have recesses that compress the amplifier assembly's snap-fit ​​or snap-fit ​​or flexible arm during insertion of the amplifier assembly into the receiving portion. The edges of these openings may retain the snap-fit ​​or snap-fit ​​or flexible arm when operating the handle assembly and the amplifier assembly (e.g., during pulsed energy transfer). In some embodiments, maintaining the orientation and operable connection of the handle assembly relative to the amplifier assembly may include one or more screws, mechanical, magnetic, or electromechanical latches, push-in connectors, etc., which may be present on the distal interface of the handle and / or the housing and / or other aspects of the handle assembly.

[0235] Additional details regarding aspects or related components of handle assemblies that may be incorporated into or used in conjunction with embodiments of the present invention are provided in the following patents: U.S. Patent No. 11,464,949; Pending PCT Application Serial No. PCT / US2020 / 055458; U.S. Application Serial No. 63 / 274,832; Pending PCT Application Serial No. PCT / US2022 / 014785; U.S. Application Serial No. 63 / 238,381; Pending PCT Application Serial No. PCT / US2022 / 040586; U.S. Application Serial No. 63 / 346,703; Pending PCT Application Serial No. PCT / US23 / 23533; U.S. Application Serial No. 63 / 346,704; Pending PCT Application Serial No. PCT / US23 / 22685; and U.S. Application Serial No. 63 / 444,414; the disclosure of each of these is incorporated herein by reference.

[0236] The various aspects of the handle assembly of the present invention have been generally described above. Now, the elements of the handle assembly will be reviewed further in the context of specific embodiments. Specific Implementation

[0237] Handle assembly according to embodiments of the present invention, such as Figure 8A -F is shown. Figure 8A -F depicts an embodiment without a housing, making it easier to see the internal components.

[0238] Figure 8AAn isometric view of the handle assembly 800 is shown, with the relatively distal region of the handle assembly 800 appearing on the left side of the figure and the relatively proximal region of the handle assembly 800 appearing on the right side of the figure.

[0239] The handle assembly 800 includes a remote interface 810. As described herein, the handle assembly of interest is mated with an amplifier assembly such that the remote interface 810 is mated with a corresponding interface of the amplifier assembly (i.e., the near-end interface of the amplifier assembly) (e.g., Figure 2A The proximal nose portion 210 shown meets and is operatively connected.

[0240] The bonding element 815 is positioned and shaped to connect the handle assembly 800 with Figure 2A The corresponding bonding elements 227 (i.e., keyways) of the amplifier assembly 200 shown are aligned. This bonding feature facilitates the operative connection of the handle assembly 800 to the amplifier assembly and the circumferential, radial, and longitudinal alignment of such assemblies.

[0241] Also located within the internal region of the remote interface 810 is the port 820. The port 820 is the output of the handle assembly 800, configured to output energy, such as pulsating or static energy, in the form of, for example, high-pressure gas. The port 820 is configured to mate with and be operatively connected to an amplifier assembly (specifically, the high-voltage connector 223 of the amplifier assembly 200).

[0242] The manifold 830 of the handle assembly 800 is operatively connected to an energy source via a connector assembly 850. The manifold 830 is configured to controllably deliver energy to the distal interface 810, specifically its orifice 820. The connector assembly 850 is located in a relatively proximal region of the handle assembly 800 and is configured to be operatively connected to the energy source. As shown in the handle assembly 800, the path from the connector assembly 850 to the orifice 820 is substantially linear, a configuration that reduces energy dissipation compared to a relatively circuitous path. Reception portions 825, configured to receive the snap-fit ​​flexible arm of the amplifier assembly, are located on opposite sides of the distal interface 810.

[0243] Figure 8B A distal view of the handle assembly 800 is depicted. The distal interface 810 includes a hole 820 over which a bonding element 815 (i.e., a key) is positioned. The bonding element 815 has a rounded outer edge, a feature that facilitates alignment of the bonding element 815 (as well as the distal interface 810 and the hole 820) with corresponding bonding elements 227 and high-voltage connectors 223 of the amplifier assembly 200. Reception portions 825 are present on both sides of the distal interface 810.

[0244] Figure 8CA top view of the handle assembly 800 is depicted. The length of the remote interface 810 is shown in this view. In this view, a manifold 830 is shown above and connected to the remote interface 810. Above the manifold 830 is the connector assembly 850. The connector assembly is operatively connected to an energy source (not shown). This view illustrates a substantially direct line from the energy input to the connector assembly 850 of the handle assembly 800 to the remote interface 810 from which energy is output from the handle assembly 800.

[0245] Figure 8D A sectional top view of the handle assembly 800 is depicted. The depth of the central region of the distal interface 810 is shown in this view. The orifice 820 is located in the relatively central region of the distal interface 810. The manifold 830 includes an oscillator, which in the handle assembly 800 is a solenoid valve 835 comprising a plunger movable between two positions: a first position connecting the output of the connector assembly 850 to the orifice 820, and a second position in which the output of the connector assembly 850 is not connected to the orifice 820. That is, in the first position of the solenoid valve 835, energy received from the energy source through the connector assembly 850 is transmitted through the handle assembly 800 such that it is output to the connected amplifier assembly at the orifice 820, and in the second position of the solenoid valve 835, energy received from the energy source through the connector assembly 850 is discharged without being output to the connected amplifier assembly at the orifice 820.

[0246] Figure 8E A side view of the handle assembly 800 is depicted. The remote interface 810 is shown at the bottom of the figure, the manifold 830 is shown above the remote interface 810, and the connector assembly 850 is shown above the manifold 830.

[0247] Figure 8F A sectional side view of the handle assembly 800 is depicted. A bonding element 815 (i.e., a key) is located within the distal interface 810. A bore 820 is also located within the distal interface 810. The fluid connection between the bore 820 and the output of the solenoid valve 835 of the manifold 830 is shown in this sectional view. The fluid connection between the solenoid valve 835 of the manifold 830 and the output of the connector assembly 850 is also shown in this sectional view.

[0248] Figure 9A -F depicts a handle assembly according to an embodiment of the present invention. Figure 9A In -F, elements with the same or similar reference numerals have the same... Figure 8A -F has the same or similar characteristics as the corresponding elements, unless otherwise explicitly stated.

[0249] Figure 9A A distal side view of the handle assembly 900 is depicted. Figure 9B-C depicts a view of the handle assembly 900 as viewed along its long axis. The handle assembly 900 is depicted as a housing 990 mounted on the handle assembly 900. Figure 9D -E depicts an isometric view of the handle assembly 900, with the relatively distal side of the handle assembly 900 shown on the left and the relatively proximal side of the handle assembly 900 shown on the right. Figure 9F A sectional side view of the handle assembly 900 is depicted.

[0250] A remote interface 910 is present on the distal surface of the handle assembly 900. Receiving portions 925 for retaining clips of the flexible arm of the amplifier assembly are present on both sides of the remote interface 910. A hole 920 is present in the central region of the remote interface 920 and is configured to engage with the high-voltage connector of the amplifier assembly. A bonding feature 915 is also present within the remote interface 910 and is configured to engage with a corresponding bonding feature of the amplifier assembly.

[0251] The housing 990 substantially covers the handle assembly 900, with aspects of the remote interface 910 and channels of the connector assembly 950 exposed. Grip points 992 comprise the textured surfaces of the housing 990, configured for manual operation of the handle assembly 900, and are present on both sides of the handle assembly 900. A button 996 is located in the central region of the handle assembly for controlling, for example, the solenoid valve 935 of the engagement manifold 930. The button 996 is surrounded by LEDs 994 for providing output to the user (e.g., a green light indicates the handle assembly 900 is operating without errors, while a red light indicates the handle assembly 900 is in an error state, and the light is off when the handle assembly 900 is closed).

[0252] Figure 9E -F shows an additional aspect of the handle assembly 900. The connector assembly 950 includes an inlet pipe and an outlet pipe 955 located in the distal region of the handle assembly 900. The inlet pipe and outlet pipe 955 are operatively connected to an energy source (not shown) and an exhaust mechanism for safely receiving exhaust gas. The manifold 930 includes an oscillator, which is a solenoid valve 935 that discharges energy when in the "closed" position. When the solenoid valve 935 is in the "open" position, energy is transmitted through the manifold 930 of the handle assembly 900 and output at the orifice 920 of the distal interface 910. A connector 957 is located at the proximal end of the inlet pipe and outlet pipe 955.

[0253] System for applying pulsating energy

[0254] As described above, a system for applying pulsating energy is provided. Aspects 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 also include a console assembly comprising an energy source operatively connected to the handle assembly.

[0255] The system or components thereof of the present invention may be configured as reusable or disposable as needed. In cases where the system (or aspects thereof) of the present invention is reusable and may come into contact with patient areas, such embodiments may be configured to be covered in a disposable sterile sheath or bag, allowing the system to be used without contaminating the sterile area of ​​the operating room.

[0256] Console components:

[0257] In an embodiment, the system of the present invention includes a console component. The console component, also referred to as a console unit or console subsystem, is used in the system of this embodiment to generate the power and control required for treatment (e.g., cardiovascular tissue) using the system.

[0258] Embodiments of the console assembly of the system according to the invention include an energy source. The energy source of embodiments of the invention is configured to provide energy that can be regulated as needed by a regulator. Any convenient energy source can be employed, examples of which include voltage sources, pressure sources, electromagnetic sources, electric field sources, chemical sources, etc. In some embodiments, the energy source is a pressure source, examples of suitable pressure sources including, but not limited to, compressed gas cylinders, compressors, etc. Where needed, the energy source can be operatively coupled to a regulator for regulating the energy from the energy source to a suitable form so that it can be further acted upon, for example, by an oscillator of the manifold assembly. For example, in the case where the energy source is a high-pressure gas source, the regulator can be used to regulate the gas pressure to a suitable value that can be input to the oscillator. In addition to positive energy sources (e.g., high-pressure gas), energy sources of interest may also include negative potentials compared to a reference or standard potential, such as energy sources configured to provide a vacuum potential compared to standard atmospheric conditions.

[0259] In some embodiments, the console component includes more than one energy source. In embodiments including more than one energy source, each energy source may provide the same type of energy or 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 while another energy source may be a voltage source.

[0260] In embodiments, the console component may further include one or more regulators (i.e., power regulators), output ports, and a controller. Regarding the power regulator, as described above, in embodiments, the energy source's energy can be adjusted from a first input energy to a second energy, such as energy suitable for transmission to an oscillator in the manifold assembly and ultimately used for treatment (e.g., cardiovascular tissue). The energy source's energy can be adjusted to a predetermined value, a user-defined value, or based on various feedback inputs occurring during treatment. In some cases, the energy source's energy can be dynamically adjusted, at least in part, based on conditions related to treatment involving the application of pulsating energy to tissue (e.g., cardiovascular tissue) (e.g., based on changes in tissue compliance during treatment, as described herein). In some cases, the energy source's energy can be adjusted in real-time or substantially in real-time. In some embodiments, the energy source's energy can be optimized for a specific treatment. For example, the energy source's energy can be optimized for the treatment of diseased cardiovascular tissue versus the treatment of diseased peripheral tissue. In some cases, one or more inputs from the console assembly, amplifier assembly, handle assembly, or from external sources (such as other measurements about the subject, such as imaging of the subject) can be used to determine the optimal treatment conditions, such as the output energy of the energy source suitable for the desired treatment, and then adjust to those conditions.

[0261] In embodiments that include a regulator (i.e., a power regulator or potential regulator) configured to regulate the energy of an energy source, such a regulator can be a passive regulator (i.e., a preset or user-adjusted regulator) or an active regulator (i.e., a regulator controlled by, for example, electrical pulses or other dynamic signals from a controller). Regulators of interest may include regulators commonly used for fluid regulation, such as directional valves or diaphragm valves, and electrical regulators such as voltage regulators, optical power regulators, etc. In embodiments that include more than one energy source, the potentials of the various energy sources can be regulated together or separately.

[0262] In this embodiment, regulated and / or unregulated energy (e.g., potential energy) from an energy source is output through an output port of a manifold operatively coupled to the handle assembly of the system. Any convenient output port, such as a commercially available connector, like a pneumatic, hydraulic, electrical, or optical connector, may be used in this embodiment. In some cases, unregulated or regulated potential energy may be converted into another form of energy before or after the energy is transferred or otherwise transmitted to the manifold of the handle assembly (in some cases).

[0263] In some cases, a console assembly may include more than one physically separate or connected unit, i.e., each unit is a console unit that can be operatively interconnected (e.g., electrical connection, fluid connection, use of radio frequency (RF), etc.). In other words, a console assembly may include a single component or two or more distinct, operatively connected units.

[0264] In some cases, at least some console component parts are present in a unit configured for hand-held or manipulated (e.g., moved by hand). While the shape factor of such a unit can vary as needed, in some cases, such a unit can be configured essentially as a rectangular box with a height ranging from 10 to 100 cm, for example 20 to 30 cm, a width ranging from 5 to 100 cm, for example 10 to 20 cm, a depth ranging from 10 to 100 cm, for example 20 to 30 cm, and a mass ranging from 1 to 20 kg, for example 5 to 8 kg.

[0265] In one embodiment, the console assembly may include a first console component housing an energy source (e.g., a pressure source) and regulators and actuators (e.g., operable buttons) for the pressure source. The console assembly may include electrical connectors for providing electrical connections to various other components of the system as needed. For example, the electrical connectors may be used to receive data, such as balloon pressure or volume measurements, and to supply power to sensors configured to collect relevant data for treatment using the system.

[0266] In some cases, at least some components of the console assembly are housed in a mountable unit configured to be positioned or secured on or near the operating table, allowing the operator (e.g., a physician) to treat the subject without physical interaction with the console assembly (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 device). In this scenario, the mountable unit is designed to be easily clamped, secured, or independently stable on or near the operating table and can be operated by a remote control unit. In this case, the mountable unit may include a communicator that provides communication between the console assembly and other controllers present within or outside the system. This can be achieved through any desired hardware and / or software configuration and can be configured to communicate using wired or wireless protocols.

[0267] The console components and / or their power sources used in the system of this invention can be configured as reusable or disposable as needed. The console components used in the system of this invention can be configured to receive sterile covers, allowing the console components to be used without contaminating the sterile area of ​​the operating room.

[0268] Controller:

[0269] Embodiments of the console assembly of the system according to the invention include a control subsystem, also referred to as a controller or control assembly. Embodiments of the system may utilize the controller to control the amount and duration of energy delivered to tissues (e.g., cardiovascular tissue). In some cases, embodiments of the system may utilize the controller to measure the effects of treatment on cardiovascular tissues, such as the degree of damage to calcified tissues, or cardiovascular tissue compliance, as described herein. In embodiments, the control assembly may be present in other components of the system, such as a handle assembly, or may be distributed across multiple components of the system, such as a console assembly and a handle assembly.

[0270] In embodiments, the control subsystem may be connected to, receive information from, and / or adjust (i.e., control) aspects thereof from one or more of the following: a console assembly (e.g., a pressure source or regulator), a handle assembly (e.g., an oscillator), or an amplifier assembly. The control subsystem may also be configured to receive information from and / or control external systems, such as electrocardiogram (ECG), intravascular or external pressure monitors, blood volume sensors, patient vital signs sensors, or imaging systems (e.g., imaging systems utilizing fluoroscopy, intravascular ultrasound (IVUS), or optical coherence tomography (OCT)). Furthermore, the control subsystem may include multiple interconnected control units, such that one or more units are synchronized and communicate with each other.

[0271] In some cases, the control subsystem (or the control unit constituting the control subsystem) can be configured to communicate with the components of the system such that the energy transmitted through the amplifier assembly is appropriate, i.e., suitable for a specific treatment involving the application of pulsatile energy to tissues such as cardiovascular tissues.

[0272] In one embodiment, the controller is configured to receive a treatment plan, i.e., control instructions related to a specific treatment for the subject. The treatment plan may include, for example, a specified potential energy, frequency, or duty cycle of an oscillator for the handpiece assembly. Furthermore, the treatment plan may include information about the type, such as size or orientation, of the pulse balloon or other tissue-attaching element to be used. Further details regarding the treatment plan, the control system, and the behavior of updating the catheter-based procedure based on collected data about the procedure are described in U.S. Application Serial No. 63 / 346,704 and Pending PCT Application Serial No. PCT / US23 / 22685; the disclosure of which is incorporated herein by reference.

[0273] In embodiments, the controller can be configured to provide feedback to the operator of the system of the invention in any convenient manner. In some cases, the controller is configured to provide tactile feedback to the operator, for example, through vibration. For example, the controller can be configured to vibrate the handle or other interface with the system operator upon relevant changes or determinations (e.g., sensor measurements, such as changes in cardiovascular tissue compliance). This tactile feedback can be used to instruct the operator of the system embodiment to change the configuration of the system.

[0274] In this embodiment, the control component is configured to implement a system workflow, namely, to interact with an operator so that the system can be used to deliver pulsating energy specified by the operator for, for example, during surgery. The control component may include hardware devices, such as one or more processors operatively connected to one or more memories storing instructions that, when executed by the processors, cause the processors to implement such a system workflow. Processors and memory devices of interest include commercially available general-purpose processors, controllers, microcontrollers, or application-specific integrated circuits (ASICs).

[0275] Figure 10A A flowchart 1000 is depicted, comprising a system activity diagram illustrating the software states of control components of a system according to an embodiment of the present invention. The workflow 1000 depicts system controller states and the transitions between them, from a startup state 1010 through a not-ready state 1020 to a ready state 1030. These system controller states and transitions are associated with certain specified interactions by the user (i.e., the operator), such as when the operator turns on the system under certain conditions within startup state 1010. These system controller states and transitions are also associated with system functions and system behaviors, such as the system performing a prime check under certain conditions within ready state 1030.

[0276] Specifically, flowchart 1000 illustrates how a system according to an embodiment of the invention interacts with its various components. Upon startup, corresponding to startup state 1010, the user interacts with the system by connecting a power source and turning it on. The system's console and handle (if / when attached) each perform internal safety checks. These safety checks may include, for example, electrical and signal integrity checks; display integrity checks; pneumatic input, output, exhaust, and connection tests; and / or maintenance checks. During or after such checks, an operation screen may be displayed to provide the user with feedback on the system's operational status. One request the system may make to the user is to connect an energy source (in this case, a carbon dioxide canister) to the system and pressurize it. Once pressurized, the system senses the pressure through continuous checks to ensure pressure input integrity. Additionally, the user is prompted to prepare the catheter, place the handle in a sterile sleeve, and then install the catheter when ready. These actions are part of the unready state 1020 of flowchart 1000, corresponding to the system controller state, where the system is not ready to initiate pulsed energy or otherwise use the system for surgery.

[0277] When the system has amplifier and / or catheter assemblies operatively connected to or otherwise attached to the system (e.g., an operative connection between the handpiece assembly and the amplifier assembly as described herein), the system is configured to identify the amplifier and / or catheter assemblies and perform pre-treatment safety checks. That is, control components can be configured (e.g., including software programmed to perform) to perform such safety checks relevant to the system. Where the system is configured to reuse certain components (e.g., handpiece or console assemblies) but not reuse (i.e., discard) such amplifier and / or catheter assemblies between uses or procedures performed by the system, these amplifier and / or catheter assemblies may be referred to as disposable or single-use components.

[0278] Such safety checks associated with disposable components (i.e., amplifier assemblies and / or conduit assemblies) include, for example: electrical integrity checks; minimum or maximum pressure checks; pneumatic integrity checks, including inlet, outlet, and exhaust; lifecycle and prior use and / or connection tests; precharge checks; indication or usage checks; and / or burst pressure rating checks.

[0279] Once the controller receives feedback (e.g., sensor data) consistent with confirmation that the amplifier assembly and / or catheter assembly have passed such safety checks, flowchart 1000 transitions to a ready state 1030, in which the system prompts the user to precharge the catheter and press a button (e.g., a button present on the handle assembly) when ready for treatment (i.e., ready to begin treatment). When such a button is pressed or when the system receives other input from the user indicating that the procedure should begin, flowchart 1000 continues to perform additional checks, including, for example: electrical integrity checks; minimum or maximum pressure checks; pneumatic integrity checks, including inlet, outlet, and exhaust; lifecycle and prior use and / or connection tests; precharge checks; indication or usage checks; burst pressure rating checks; and / or initial pressure tests. The control components may be configured to perform such checks simultaneously or substantially simultaneously or continuously or persistently.

[0280] Furthermore, the control components can be configured to enable the system to track and record various system states and sensor values ​​before, during, or after treatment using the system, for continuous learning, maintenance checks, data tagging, etc. This data can be stored locally or in a distributed storage system, or it can be transferred to an external computing device (e.g., a computer tablet) or uploaded to a cloud-based storage system, for example.

[0281] Figure 10B A flowchart 1000B depicts another embodiment of the software control of the system according to the present invention.

[0282] Exemplary graphical user interface screens according to embodiments of the present invention, such as Figure 10C As shown. In system embodiments of the invention, one or more elements may include a display screen. In some embodiments, the console unit includes a display screen and associated hardware and software configured to present a graphical user interface 1050. The graphical user interface 1050 is divided into multiple boxes or panes. The treatment pane 1054 of the graphical user interface 1050 includes a countdown timer for providing treatment deployment and timeout information (e.g., forced pause of treatment deployment). When the system is able to treat, i.e., when performing surgery, i.e., when generating and transmitting pulsating energy, the text in the treatment pane 1054 is displayed in a specific color, such as white; when the system is unable to treat, the text in the treatment pane 1054 is displayed in a different color, such as gray (but still visible). When the system engages to deploy treatment, a countdown from the maximum allowed continuous treatment time to zero is displayed in the treatment pane 1054; in the treatment pane 1054, the countdown timer has 45 seconds remaining. After the maximum allowed treatment time has been reached, the treatment pane 1054 displays a countdown timer to reflect the system timeout during which treatment could not be deployed. The top of the treatment pane 1054 displays the text "Run," which can be updated to reflect the timeout count.

[0283] When the system instructs the operator or user to precharge the system's conduit assembly, the precharge pane 1053 of the graphical user interface 1050 is highlighted. When the system does not instruct the operator to precharge the conduit assembly, the gauges and associated text displayed in the precharge pane 1053 are displayed in a different color or intensity, such as graying out, and in some cases, the precharge pressure value text is replaced by another symbol (such as "--").

[0284] The system status pane 1051 of the graphical user interface 1050 is updated to provide information on system status and / or software status and / or controller status. The graphical user interface 1050 can also be configured to display a logo in the system status pane 1051.

[0285] The total catheter life pane 1055 of the graphical user interface 1050 includes an accumulation bar from zero to the total permissible therapeutic life of the system catheters. In an embodiment of the graphical user interface 1050, the bar is filled with a specified color (e.g., yellow), and dots of that color (e.g., yellow) move from left to right until the dots reach the vertical line to the right of the total catheter life pane 1055.

[0286] When the system's catheter is used without being unloaded, the total catheter life pane 1055 will display the gaps between pulse cycles. In an embodiment, a pulse cycle is the interval between consecutive deployments of treatment (i.e., the time interval between the operator pressing a button (i.e., a button on the system's handle assembly configured to initiate treatment) before release). In an embodiment, the maximum pulse cycle time is the maximum permissible continuous treatment time (this corresponds to 45 seconds as indicated in the treatment pane 1054). If the operator unloads and reinstalls the pulsed catheter assembly, this gap will not exist, but the bar in the catheter life pane 1055 will be displayed in a designated color (e.g., yellow), and the dot will be positioned at a designated location. In an embodiment, the system can be configured not to record the time from the occurrence of a pulse cycle to the catheter assembly software, but rather to record the total number of pulses applied by the system.

[0287] The notification pane 1056 of the graphical user interface 1050 provides the operator (i.e., the user) with additional information about system usage, status, or condition. In an embodiment, the color of the notification pane 1056 reflects the system status; that is, the color of the notification pane 1056 can change according to the system status. In an embodiment, the color of the notification pane 1056 can be selected to match the color of the light-emitting diodes of the buttons on the handle assembly (when present).

[0288] The subsystem status pane 1052 of the graphical user interface 1050 provides a single location for all information about each subsystem of the system (e.g., the operational and / or error status of different subsystems of the system). This information is distributed across the duct subpane, handle subpane, console subpane, and CO2 tank pane.

[0289] In the catheter sub-pane of subsystem status pane 1052, the color of the catheter icon indicates the catheter's status. For example, in an embodiment, a catheter may be displayed as gray to indicate an unconnected catheter; green to indicate an operable catheter; and orange to indicate an error and / or to indicate that the operator (i.e., the user) should replace the catheter. In an embodiment, the catheter sub-pane of subsystem status pane 1052 may indicate connected / disconnected based on the installation status of the system's catheter assembly. In an embodiment, balloon length and / or diameter information may be updated based on information retrieved from the catheter assembly (i.e., the system's amplifier assembly has memory that can be read by the system). In an embodiment, the balloon status may have three states (i.e., not pre-filled, pre-filled, or treatment being delivered), and this may be reflected in this aspect of the graphical user interface 1050. In an embodiment, when the system is deploying treatment, the pulse count value is updated, and this value may be consistent with the value displayed in the total catheter life pane 1055.

[0290] In the handle subpane of subsystem status pane 1052, the color of the handle icon indicates the status of the system's handle assembly. For example, the handle may be displayed in a specific color (e.g., green) to indicate that the conduit is operable, or another color (e.g., orange) to indicate that an error has occurred or that the handle assembly should not disconnect during normal use, or yet another color (e.g., red) to indicate that an internal error has occurred and the operator should contact service for support. The handle subpane of subsystem status pane 1052 may further provide the connection status of the handle assembly.

[0291] In the console subpane of the subsystem status pane 1052, the color of the console icon indicates the status of the system's console components. For example, the console may be displayed in a specific color (e.g., green) to indicate that the console is operable, or another color (e.g., orange) to indicate that an error has occurred, or yet another color (e.g., red) to indicate that an internal error has occurred and the operator should contact service for support. The console subpane of the subsystem status pane 1052 may further provide the connectivity status of the console components.

[0292] In the CO2 tank pane of subsystem status pane 1052, the graphical user interface 1050 is configured such that the tank icon fill level reflects the tank pressure. In embodiments of the tank pane of subsystem status pane 1052, a designated color (e.g., green) indicates that the pressure is at a sufficient level; another designated color (e.g., orange) indicates that the pressure is low, allowing the operator (i.e., the user) to continue using the system, but requiring immediate replacement of the energy source (e.g., the CO2 tank). Yet another color (e.g., red) indicates that the pressure is too low, requiring replacement of the energy source (e.g., the CO2 tank).

[0293] The graphical user interface 1050 is further configured or designed such that error states are displayed as pop-up windows, such as pop-up boxes on a display. In embodiments, the color of the pop-up window reflects the urgency of the notification. For example, in embodiments, a pop-up window / notification of a specific color (e.g., blue) is associated with a normal work item that guides the user to perform a task; another color (e.g., orange) is associated with a requirement that requires user action; text may be presented in the pop-up window to provide the operator with guidance on correcting the error state. Yet another color (e.g., red) indicates that an internal error has occurred and the operator should contact service for support. In embodiments, the notification pane 1056 reflects a color associated with the system status; for example, a green notification pane 1056 indicates that the system status is ready to deploy treatment and / or is being deployed.

[0294] Figure 11 Aspects of a system according to embodiments of the present invention are described. Figure 11 In the figures, elements with the same or similar reference numerals have the same... Figure 1A The corresponding elements in -D have the same or similar characteristics, unless otherwise explicitly stated.

[0295] System 1102 includes a handle assembly 1101 shown in a transparent isometric view. The handle 1101 is shown oriented relative to amplifier assembly 1100 to illustrate how the handle assembly 1101 is operatively connected to amplifier assembly 1100. Amplifier assembly 1100 is also shown in a transparent and sectional isometric view, such that the distal region of amplifier assembly 1100 is depicted on the right side of the figure. A console assembly 1103 is shown in a sectional isometric view. Console assembly 1103 is operatively connected to handle assembly 1101 such that pulsating energy (e.g., pressurized fluid) is transferred from console assembly 1103 to handle assembly 1101. Console assembly 1103 is also connected to carbon dioxide tank 1104, which is the energy source for system 1102.

[0296] Figure 11Aspects of system 1102 configured to enable and / or perform system safety checks are also described. These safety checks are designed to ensure that system 1102 does not damage downstream components. System 1102 is configured to perform safety checks related to: ensuring the use of appropriately rated can-to-console connector hoses to prevent connection to other gas / canister types by utilizing built-in connectors, and the presence of pressure check valves to prevent user exposure to gas during accidental or intentional disconnection of canisters or other energy sources; preventing pneumatic system contamination by utilizing check valve inlets; ensuring correct inlet and outlet pressures by utilizing mechanical regulators with preset inlet, canister, and / or outlet pressure sensors; and allowing system 1102 to control outlet pressure by utilizing electronic regulators / proportional control valves (in some embodiments, mechanical and electronic regulators may be combined into a single unit / manifold). A handle pressure sensor is used to ensure that the output of the electronic regulator matches the pressure in the handle; the solenoid valve opening pressure is considered so that even if extremely high-pressure fluid passes downstream, the solenoid valve of the console assembly 1103 will not output pressure downstream, but will instead discharge fluid like a pressure relief valve; solenoid valve control is used so that if the handle pressure sensor is out of range, i.e., beyond the expected or acceptable range, the sensor prevents the solenoid valve from activating; the amplifier 1100 is configured to signal or otherwise inform the system 1102 (i.e., the controller of the system 1102) of the normal treatment pressure, the maximum permissible pressure, and the lifespan of disposable components (e.g., amplifier assembly 1100 and / or catheter assembly). In the event of balloon rupture, a Hall sensor integrated into the diaphragm of the amplifier 1100 is configured to detect the rupture and cause hardware in the handle 1101 (e.g., a comparator with a known voltage) to prevent further treatment, i.e., to prevent further energy transfer to the amplifier assembly 1100.

[0297] A system for applying pulsating energy according to embodiments of the present invention, such as Figure 12 As shown. System 1202 includes an amplifier subsystem or component 1200 and a handle subsystem or component 1201. The amplifier subsystem or component 1200 and the handle subsystem or component 1201 are connected to allow the transmission of electrical signals, power or grounding, and pneumatic energy between these components.

[0298] The amplifier subsystem 1200 is operatively connected to the catheter subsystem or assembly 1205. The catheter subsystem 1205 includes tissue bonding elements (not shown), such as a distal balloon or cardiac tissue bonding element.

[0299] The handle subsystem or component 1201 is operatively connected to the control console 1203, allowing the transfer of electrical signals, power or grounding, and pneumatic energy between these components. The control console subsystem 1203 receives energy in the form of pressurized gas from the gas tank 1204. The control console subsystem 1203 is also operatively connected to a power source 1206.

[0300] System 1202 is shown in schematic form to illustrate system deployment. 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 and, together with an external power source 1206 and an energy source 1204 (in this case, pressurized gas), produce a pulsating intravascular lithotripsy effect.

[0301] The console subsystem 1203 is configured to manage the regulation and setting of power, electrical signals, and energy output. The handle subsystem 1201 is configured to manage energy output and discharge, 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 it into hydraulic shocks, and directs the shocks to the catheter subsystem 1205. The amplifier subsystem 1200 also manages and reads multiple sensors to ensure safe treatment. The catheter subsystem 1205 receives the shocks from the amplifier 1200, transmits them through the catheter tube, and delivers energy from the distal balloon to calcifications (e.g., lesions) while minimizing input signal attenuation.

[0302] Additional details regarding aspects or related components of systems for applying pulsating energy that can be incorporated into or used in conjunction with embodiments of the present invention, including, for example, further details regarding console units, energy sources, oscillators, regulators, etc., are provided in the following patents: U.S. Patent No. 11,464,949; Pending PCT Application Serial No. PCT / US2020 / 055458; U.S. Application Serial No. 63 / 274,832; Pending PCT Application Serial No. PCT / US2022 / 0147 85; U.S. Application Serial No. 63 / 238,381; Pending PCT Application Serial No. PCT / US2022 / 040586; U.S. Application Serial No. 63 / 346,703; Pending PCT Application Serial No. PCT / US23 / 23533; U.S. Application Serial No. 63 / 346,704; Pending PCT Application Serial No. PCT / US23 / 22685; and U.S. Application Serial No. 63 / 444,414; the disclosure of each of these items is incorporated herein by reference.

[0303] method

[0304] The systems of this invention can be used in a variety of applications. In some cases, these systems can be used to break up hardened material embedded within an elastic catheter. For the embodiments presented herein, this disclosure describes applications related to treating atherosclerotic calcification within arterial catheters (e.g., coronary or peripheral arteries). However, the systems and teachings are not limited to atherosclerotic calcification or arterial catheters and can be generally applied to other applications identified by those skilled in the art. This is particularly true for cases involving altered arterial compliance (i.e., the vascular compliance of an artery) or involving medical interventions (e.g., the presence of a prior stent followed by occlusion). Vascular compliance is altered by the intraluminal placement of a prior stent. Data and feedback from vascular compliance curves can be used for future treatments and predictive techniques, such as machine learning techniques.

[0305] In some cases, various embodiments of the system described herein are used in methods of dynamic balloon angioplasty (DBA), where the technique uses pressure oscillations with a generalized waveform (in some embodiments, harmonics or pressure waveform oscillations of a specific frequency) to effectively and safely rupture calcified lesions during angioplasty. In some cases, various embodiments of the system described herein are used in methods of assessing in vivo vascular compliance, where vascular compliance is a measurable characteristic of a blood vessel, calculated as the ratio of vascular volume change under a given pressure change. The system according to the invention can be configured to assess vascular compliance by obtaining in vivo measurements of volume change under different pressures (or pressure changes) applied to the blood vessel. For example, such vascular compliance measurements can be performed during treatment.

[0306] Methods for applying pulsating energy to tissue are also provided, and similar benefits are found in the applications described herein. The method according to the invention includes deploying a system comprising an amplifier assembly and a handpiece assembly (as described herein) such that a tissue-attaching element operatively connected to the system is adjacent to the tissue. The components of the system, amplifier assembly, and handpiece assembly are described in detail above. The term "tissue-attaching element" refers to any treatment-related element capable of receiving pulsating or static energy in the form delivered by the amplifier assembly. The tissue-attaching element is configured for treating diseased tissue. Tissue-attaching elements of interest include, for example, distal balloons, such as compliant or non-compliant distal balloons or modifications thereof, or cardiac tissue-attaching elements.

[0307] The method according to the invention further includes engaging the system in a manner that applies energy to the tissue. For example, such a method may include applying pulsating energy to the tissue or applying static energy to the tissue (i.e., by inflating a distal balloon to a static pressure or volume for a period of time). In embodiments, applying pulsating energy means repeatedly pressurizing a distal region (e.g., a distal chamber) of the amplifier assembly; for example, the distal chamber of a 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. These pressure oscillations originate from the handle assembly and are thereby transmitted to the amplifier assembly, as described in detail above in embodiments of the engaging system, amplifier assembly, and handle assembly. Any suitable amplitude, frequency, duty cycle, and duration of pressure oscillations can be used, and these can be varied.

[0308] This method can be used to apply pulsatile energy to tissue locations in any number of different subjects. In some cases, the subjects are “mammals” or “mammal-like,” terms widely used to describe organisms belonging to the class Mammalia, including 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.

[0309] Further details regarding the methods applicable to embodiments of the present invention, including further details regarding dynamic balloon angioplasty (DBA) and vascular compliance, are found in U.S. Patent No. 11,464,949; Pending PCT Serial No. PCT / US2020 / 055458; U.S. Application Serial No. 63 / 274,832; Pending PCT Serial No. PCT / US2022 / 014785; U.S. Application Serial No. 63 / 238,381; Pending PCT Serial No. PCT / US2022 / 040586; U.S. Application Serial No. 63 / 346,703; Pending PCT Serial No. PCT / US23 / 23533; U.S. Application Serial No. 63 / 346,704; Pending PCT Serial No. PCT / US23 / 22685; and U.S. Application Serial No. 63 / 444,414; the disclosure of each of these is incorporated herein by reference.

[0310] kit

[0311] Kits are also provided that include components or systems or one or more of their parts (e.g., as described above). Therefore, in some cases, a kit may include one or more amplifier components or handpiece components, or systems including amplifier components and handpiece components, in each case, with or without a console and / or energy source (e.g., a pressure source) or components thereof. Kit components may be contained in a package, which may be sterile if desired. Kit components may be disposable or reusable if needed. In some cases, a kit may include multiple components, including multiple versions of the same component in different sizes, for example, multiple amplifier assemblies or multiple catheters in different sizes.

[0312] The kit may also contain instruction manuals for using the kit components. These manuals may be recorded on a suitable recording medium. For example, they may be printed on a substrate such as paper or plastic. Therefore, the manuals may exist as packaging inserts within the kit, on labels on the kit's container or its components (i.e., associated with the packaging or sub-packaging), etc. In other embodiments, the manuals may exist as electronic storage data files on a suitable computer-readable storage medium (e.g., a portable flash drive, DVD, or CD-ROM). The manuals may take any form, including complete instructions on how to use the device or website addresses for instructions published on the World Wide Web.

[0313] The following exemplary embodiments are provided in an illustrative manner, not in a limiting manner.

[0314] Additional exemplary embodiments

[0315] Figure 13 An exemplary prototype of a proximal nose 1300 of an amplifier assembly according to the present invention is shown. The proximal nose 1300 includes a high-voltage connector 1301. The proximal nose 1300 and the high-voltage connector are formed of dissimilar materials (plastic and metal, respectively).

[0316] Figure 14 An exemplary prototype of a distal waveguide 1400 of an amplifier assembly according to the present invention is shown. The distal waveguide 1400 includes a generally bell-shaped form, with a proximal facet 1401 present on the proximal side of the distal waveguide 1400.

[0317] Figure 15A-B illustrates a prototype exemplary embodiment of a diaphragm 1500 of an amplifier assembly according to the present invention. The diaphragm 1500 is integrated with a Hall sensor and associated electronic components 1501. The Hall sensor 1500 includes a probe 1502 located near the center of the diaphragm 1500. The diaphragm 1500 includes a shape having pleats or folds 1503 such that the diaphragm is configured to translate between the distal end face of the proximal nose and the proximal end face of the distal waveguide without generating strain on the diaphragm 1500.

[0318] Figure 16 A prototype exemplary embodiment of the proximal nose 1600 of the amplifier assembly according to the present invention is shown. The proximal nose 1600 is integrated with the electronic assembly 1602 of the diaphragm 1601.

[0319] Figure 17A -D illustrates an assembly of an amplifier assembly 1700 according to the present invention. The amplifier assembly 1700 includes an electronic assembly 1702. The electronic assembly 1702 includes a connector plate 1703 oriented on the outer surface of the amplifier assembly 1700 such that the amplifier assembly 1700 can be reliably associated with a handle assembly (not shown), and this electrical connector interconnects with a 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 with an O-ring 1705.

[0320] Notwithstanding the appended claims, this disclosure is also defined by the following provisions:

[0321] 1. An amplifier assembly, the assembly comprising:

[0322] The proximal nasal region, including the distal face;

[0323] The distal waveguide, including the near-end face; and

[0324] A diaphragm is compressed between the proximal nose and the distal waveguide, thereby sealing the proximal chamber and the distal chamber.

[0325] The diaphragm is configured to translate between the distal face of the proximal nose and the proximal face of the distal waveguide without generating strain on the diaphragm.

[0326] 2. The amplifier assembly according to Clause 1, wherein the proximal chamber is defined by a first volume between the diaphragm and the distal face of the proximal nose.

[0327] 3. The amplifier assembly according to any of the preceding clauses, wherein the distal chamber is defined by a second volume between the diaphragm and the proximal face of the distal waveguide.

[0328] 4. The amplifier assembly according to any of the preceding clauses, wherein the diaphragm is configured to occupy a different position between the distal face of the proximal nose and the proximal face of the distal waveguide.

[0329] 5. The amplifier assembly according to any of the preceding clauses, wherein the diaphragm is configured to occupy a different position between the distal face of the proximal nose and the proximal face of the distal waveguide without generating strain on the diaphragm material.

[0330] 6. The amplifier assembly according to any of the preceding clauses, wherein the diaphragm is configured to conform to a new shape, thereby occupying a different position between the distal end face of the proximal nose and the proximal end face of the distal waveguide.

[0331] 7. The amplifier assembly according to any of the preceding clauses, wherein the diaphragm is configured to adhere to the distal end face of the proximal nose at a proximal position of the diaphragm and to adhere to the proximal end face of the distal waveguide at a distal position of the diaphragm.

[0332] 8. The amplifier assembly according to Clause 7, wherein the diaphragm includes a shape that conforms to the distal face of the proximal nose at a proximal position of the diaphragm and conforms to the proximal face of the distal waveguide at a distal position of the diaphragm.

[0333] 9. The amplifier assembly according to any of the preceding clauses, wherein the diaphragm includes folds.

[0334] 10. The amplifier assembly according to any of the preceding clauses, wherein the diaphragm includes pleats.

[0335] 11. The amplifier assembly according to any of the preceding clauses, wherein the diaphragm comprises a corrugated tube.

[0336] 12. The amplifier assembly according to any of the preceding clauses, wherein the diaphragm includes a shape adapted to fit within a recess in the distal face of the proximal nose and a shape adapted to fit within a recess in the proximal face of the distal waveguide.

[0337] 13. The amplifier assembly according to any of the preceding clauses, wherein not generating strain on the diaphragm includes not generating tension on the diaphragm.

[0338] 14. The amplifier assembly according to any of the preceding clauses, wherein not generating strain on the diaphragm includes not stretching the diaphragm material.

[0339] 15. The amplifier assembly according to any of the preceding clauses, wherein the diaphragm is configured to translate without resistance from the diaphragm material.

[0340] 16. The amplifier assembly according to any of the preceding clauses, wherein the diaphragm is configured to translate without applying stress to the diaphragm material.

[0341] 17. The amplifier assembly according to any of the preceding clauses, wherein the outer ring of the diaphragm seals the interface between the proximal nose and the distal waveguide.

[0342] 18. The amplifier assembly according to any of the preceding clauses, wherein the diaphragm includes a circumferential protrusion configured such that the diaphragm can maintain its seal while translating between the distal end face of the proximal nose and the proximal end face of the distal waveguide.

[0343] 19. The amplifier assembly as described in Clause 18, wherein the circumferential protrusion is a T-shaped edge.

[0344] 20. The amplifier assembly according to any of the preceding clauses, wherein the proximal nose includes a proximal interface located at a proximal region of the proximal nose.

[0345] 21. The amplifier assembly as described in Clause 20, wherein the near-end interface includes a high-voltage connector.

[0346] 22. The amplifier assembly according to Clause 21, wherein the high-voltage connector is in fluid communication with the proximal chamber.

[0347] 23. The amplifier assembly according to Clause 21, wherein the high-voltage connector is configured to receive high-voltage fluid.

[0348] 24. The amplifier assembly according to Clause 21, wherein the high-voltage connector is configured to receive a high-voltage fluid pulse.

[0349] 25. The amplifier assembly according to any one of clauses 23 to 24, wherein the high-pressure fluid comprises a gas.

[0350] 26. The amplifier assembly according to any one of clauses 23 to 25, wherein the high-pressure fluid includes air.

[0351] 27. The amplifier assembly according to any one of clauses 21 to 26, wherein the high-voltage connector comprises metal.

[0352] 28. The amplifier assembly according to Clause 27, wherein the metal of the high-voltage connector is molded into the plastic of the proximal interface.

[0353] 29. The amplifier assembly according to any one of clauses 21 to 28, wherein the high-voltage connector includes an O-ring groove configured to receive an O-ring.

[0354] 30. The amplifier assembly according to Clause 29, wherein the high-voltage connector includes an O-ring disposed on the O-ring groove.

[0355] 31. The amplifier assembly according to any of the preceding clauses, wherein the near-end interface includes a bonding surface.

[0356] 32. The amplifier assembly according to Clause 31, wherein the bonding surface comprises one or more of the following: a slotted notch, an asymmetric channel, an elliptical shape, and a rectangular prism.

[0357] 33. The amplifier assembly according to any of the preceding clauses further includes electrical components integrated into one or more of the proximal nose, the distal waveguide, and the diaphragm.

[0358] 34. The amplifier assembly as described in Clause 33, wherein the electrical assembly includes a plurality of electrical connectors integrated into the near-end interface.

[0359] 35. An amplifier assembly according to any one of clauses 33 to 34, wherein the near-end interface is configured such that the electrical connector establishes an electrical connection perpendicular to the long axis of the amplifier assembly.

[0360] 36. The amplifier assembly according to any one of clauses 33 to 35, wherein the electrical connector comprises a plurality of plates configured to mate with a plurality of ball connectors.

[0361] 37. The amplifier assembly according to any one of clauses 33 to 36, wherein the electrical connectors include a ground plane spanning the entire length of the plurality of electrical connectors.

[0362] 38. The amplifier assembly described in any of clauses 33 to 37, wherein the electrical assembly includes circuitry.

[0363] 39. The amplifier assembly described in any of clauses 33 to 38, wherein the electrical assembly includes a memory.

[0364] 40. The amplifier assembly according to Clause 39, wherein the memory includes one or more of the following: position sensor readings and pressure sensor readings.

[0365] 41. The amplifier assembly according to any of the preceding clauses, wherein the distal waveguide includes a conduit interface located in the distal region of the distal waveguide.

[0366] 42. The amplifier assembly according to clause 41, wherein the catheter interface is in fluid communication with the distal chamber.

[0367] 43. The amplifier assembly according to any one of clauses 41 to 42, wherein the conduit interface includes a Luer lock.

[0368] 44. The amplifier assembly as described in Clause 43, wherein the Luer lock is a floating Luer lock.

[0369] 45. The amplifier assembly according to any one of clauses 41 to 44, wherein the conduit interface is configured to receive high-pressure fluid.

[0370] 46. ​​The amplifier assembly according to any one of clauses 41 to 45, wherein the conduit interface is configured to receive high-pressure fluid pulses.

[0371] 47. The amplifier assembly as described in Clause 46, wherein the high-pressure fluid comprises physiological saline.

[0372] 48. The amplifier assembly according to any of the preceding clauses further includes a pin configured to hold the distal waveguide against the compression of the diaphragm and the proximal nose.

[0373] 49. The amplifier assembly as described in Clause 48, wherein the pin is a steel pin.

[0374] 50. The amplifier assembly according to any of the preceding clauses further includes a pressure sensor configured to sense fluid pressure within the distal waveguide.

[0375] 51. The amplifier assembly according to Clause 50, wherein the pressure sensor is integrated into the distal waveguide.

[0376] 52. The amplifier assembly according to any one of clauses 50 to 51, wherein the pressure sensor is configured to sense the pressure within the distal chamber.

[0377] 53. The amplifier assembly according to any one of clauses 50 to 52, wherein the pressure sensor is electrically connected to the electrical assembly.

[0378] 54. The amplifier assembly according to any of the preceding clauses further includes a sensor configured to sense the position of the diaphragm.

[0379] 55. The amplifier assembly as described in Clause 54, wherein the sensor is a Hall sensor.

[0380] 56. The amplifier assembly according to any one of clauses 54 to 55, wherein said sensor comprises:

[0381] A first magnet integrated into the proximal nose portion;

[0382] A second magnet integrated into the distal waveguide and located at a specified distance from the first magnet; and

[0383] An electrical probe located in the central region of the diaphragm.

[0384] 57. The amplifier assembly according to Clause 56, wherein the proximal nose includes a first container configured to hold the first magnet in a fixed position.

[0385] 58. The amplifier assembly according to any of the preceding clauses, wherein the distal waveguide includes a second container configured to hold the second magnet in a fixed position.

[0386] 59. The amplifier assembly as described in Clause 58, wherein the first container and the second container include compression ribs.

[0387] 60. The amplifier assembly according to any one of clauses 56 to 59, wherein the electrical probe is electrically connected to the electrical assembly.

[0388] 61. The amplifier assembly according to any of the preceding clauses further includes a magnet integrated into the central region of the diaphragm.

[0389] 62. The amplifier assembly according to any of the preceding clauses further includes:

[0390] A housing, wherein the proximal nose, the distal waveguide, and the diaphragm are located within the housing.

[0391] 63. The amplifier assembly according to Clause 62, wherein the housing includes one or more snap-fit ​​housings configured to substantially enclose the proximal nose, the distal waveguide, and the diaphragm.

[0392] 64. The amplifier assembly according to any one of clauses 61 to 63, wherein the housing includes one or more flexible arms for mating with the handle assembly.

[0393] 65. The 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.

[0394] 66. The amplifier assembly according to any one of clauses 64 to 65, wherein the one or more flexible arms are configured to provide tactile feedback for docking with the handle assembly.

[0395] 67. An amplifier assembly according to any one of clauses 62 to 66, wherein the housing includes one or more recessed segments configured for manual gripping of the amplifier assembly.

[0396] 68. A handle assembly for controllably transmitting energy, the assembly comprising:

[0397] A connector assembly that is operatively connected to an energy source;

[0398] A manifold, operably connected to the energy source via the connector assembly, and configured to controllably deliver energy to a remote interface; and

[0399] The remote interface is operatively connected to the output of the manifold and is configured to transmit energy received from the manifold.

[0400] 69. The handle assembly according to Clause 68, wherein the manifold includes an oscillator operatively connected to the energy source.

[0401] 70. The handle assembly according to Clause 69, wherein the oscillator is configured to transmit energy through the manifold in a first position and discharge energy in a second position.

[0402] 71. The handle assembly according to any one of clauses 69 to 70, wherein the oscillator is a solenoid valve.

[0403] 72. The handle assembly according to any one of clauses 68 to 71, wherein the connector assembly includes an input connector and an exhaust connector, wherein the input connector is operatively connected to an energy source and the exhaust connector is configured to exhaust energy from the energy source.

[0404] 73. The handle assembly according to any one of clauses 68 to 72, wherein the connector assembly includes a tube.

[0405] 74. The handle assembly as described in Clause 73, wherein the connector assembly includes an inlet pipe and an exhaust pipe.

[0406] 75. The handle assembly according to Clause 74, wherein the input pipe is operatively connected to an energy source, and the exhaust pipe is configured to discharge energy from the energy source.

[0407] 76. The handle assembly according to any one of clauses 68 to 75, wherein the manifold is operatively connected to the energy source via an input connector of the connector assembly.

[0408] 77. The handle assembly according to any one of clauses 68 to 76 further includes electrical components electrically connected to an aspect of the manifold.

[0409] 78. The handle assembly as described in Clause 77, wherein the electrical component is configured to control the oscillator.

[0410] 79. The handle assembly according to Clause 78, wherein the electrical component is configured to move the oscillator from a first position to a second position.

[0411] 80. A handle assembly according to any one of clauses 77 to 79, wherein the electrical component is configured to interface with an external component.

[0412] 81. The handle assembly according to any one of clauses 77 to 80, wherein the electrical component is configured to receive input from an external component.

[0413] 82. The handle assembly according to any one of the clauses 77 to 81, wherein the electrical component is electrically connected to a plurality of pin connectors.

[0414] 83. The handle assembly according to any one of clauses 68 to 82, wherein the handle is configured to be held by an operator.

[0415] 84. The handle assembly as described in Clause 83, wherein the handle is configured to be held by an operator during use.

[0416] 85. The handle assembly described in any of the clauses 68 to 84, wherein the weight of the handle is between 0.5 lbs and 2.5 lbs.

[0417] 86. The handle assembly described in any of Clauses 68 to 85, wherein the circumference of the handle is between 1.5 inches and 5.0 inches.

[0418] 87. The handle assembly described in any of Clauses 68 to 86, wherein the length of the handle is between 4.0 inches and 8.0 inches.

[0419] 88. A handle assembly according to any one of clauses 68 to 87, wherein the handle includes one or more tactile features.

[0420] 89. The handle assembly as described in Clause 88, wherein the tactile feature includes a groove or recess.

[0421] 90. The handle assembly according to any one of clauses 68 to 89 further includes a housing, wherein the manifold is present in the housing.

[0422] 91. The handle assembly described in any of the clauses 68 to 90 further includes operator controls.

[0423] 92. The handle assembly as described in Clause 91, wherein the operator control includes buttons.

[0424] 93. The handle assembly according to any one of clauses 91 to 92, wherein the operator control is configured to activate the oscillator.

[0425] 94. The handle assembly according to any one of clauses 91 to 93, wherein the operator controls include output elements.

[0426] 95. The handle assembly as described in Clause 94, wherein the output element indicates the handle status.

[0427] 96. The handle assembly according to any one of clauses 94 to 95, wherein the output element comprises one or more lights.

[0428] 97. The handle assembly according to any one of clauses 94 to 96, wherein the output element is integrated into the button.

[0429] 98. The handle assembly described in any of Clauses 68 to 97 is configured to perform a system self-test.

[0430] 99. The handle assembly as described in Clause 98, wherein the system self-test is performed before the oscillator is activated.

[0431] 100. The handle assembly according to any one of Clauses 98 to 99, wherein the system self-test detects leakage from the energy source.

[0432] 101. A handle assembly according to any one of the clauses 98 to 100, wherein the system self-test detects leakage from the energy source in one or more external components operatively connected to the handle.

[0433] 102. A handle assembly according to any one of the clauses 98 to 101, wherein the system self-test evaluates whether the amplifier assembly according to any one of the clauses 1 to 67 is operatively connected to the handle assembly.

[0434] 103. A handle assembly according to any one of the clauses 98 to 102, wherein the system self-test evaluates whether an amplifier assembly operatively connected to the handle assembly according to any one of the clauses 1 to 67 is operating in the specified manner.

[0435] 104. A handle assembly according to any one of the clauses 98 to 103, wherein the system self-test evaluates whether the amplifier assembly according to any one of the clauses 1 to 67 is operating in the specified manner.

[0436] 105. A handle assembly according to any one of the clauses 98 to 104, wherein the system self-test assesses whether the diaphragm of the amplifier assembly according to any one of the clauses 1 to 67 is displaced in response to the transfer of energy from the handle assembly to the amplifier assembly.

[0437] 106. The handle assembly according to clause 105, wherein the diaphragm is displaced by a specified amount.

[0438] 107. The handle assembly according to any one of clauses 68 to 106, wherein the remote interface includes one or more alignment features.

[0439] 108. The handle assembly as described in Clause 107, wherein the alignment feature includes a bonding protrusion.

[0440] 109. The handle assembly according to any one of clauses 68 to 108, wherein the remote interface is configured to operatively interface with an external component.

[0441] 110. The handle assembly described in any of the clauses 68 to 109 is configured to operatively dock with the amplifier assembly described in any of the clauses 1 to 67.

[0442] 111. A handle assembly according to any one of the provisions 68 to 110, wherein the handle assembly includes one or more aspects configured to operatively interface with an amplifier assembly according to any one of the provisions 1 to 67.

[0443] 112. The handle assembly according to any one of the clauses 68 to 111, wherein the handle assembly includes a shape configured to be releasably associated with the amplifier assembly according to any one of the clauses 1 to 67.

[0444] 113. A handle assembly according to any one of the clauses 68 to 112, wherein the handle assembly includes one or more aspects configured to be operatively connected to an amplifier assembly according to any one of the clauses 1 to 67.

[0445] 114. The handle assembly according to any one of the clauses 68 to 113, wherein the handle assembly includes a fluid connection to the amplifier assembly according to any one of the clauses 1 to 67.

[0446] 115. The handle assembly according to any one of the clauses 68 to 114, wherein the handle assembly includes an electrical connection to the amplifier assembly according to any one of the clauses 1 to 67.

[0447] 116. The handle assembly according to any one of clauses 68 to 115, wherein the handle assembly includes an interlocking device.

[0448] 117. The handle assembly as described in Clause 116, wherein the interlocking device is configured to disable power transfer when the handle assembly cannot detect the amplifier assembly.

[0449] 118. The handle assembly according to any one of clauses 116 to 117, wherein the interlocking device is configured to ensure that the amplifier is operatively connected to the handle assembly.

[0450] 119. A handle assembly according to any one of clauses 116 to 118, wherein the interlocking device is configured to allow the handle assembly to transfer energy to the amplifier assembly when the amplifier assembly is operatively connected to the handle assembly.

[0451] 120. A handle assembly according to any one of clauses 116 to 119, wherein the interlocking device is configured to prevent the handle assembly from transmitting energy to the amplifier assembly when the amplifier assembly is not operatively connected to the handle assembly.

[0452] 121. The handle assembly according to any one of clauses 68 to 120, wherein the distal interface is configured to operatively dock with the proximal nose of the amplifier assembly.

[0453] 122. The handle assembly according to any one of clauses 68 to 121, wherein the alignment feature of the distal interface is configured to mate with a corresponding alignment feature of the proximal nose of the amplifier assembly.

[0454] 123. The handle assembly as described in Clause 122, wherein the alignment features of the proximal nose of the amplifier assembly include a bonding surface.

[0455] 124. The handle assembly according to any one of the clauses 68 to 123, wherein the electrical components of the handle assembly are configured to be electrically connected to the electrical components of the amplifier assembly.

[0456] 125. The handle assembly as described in Clause 124, wherein the electrical components of the handle assembly include a plurality of electrical connectors.

[0457] 126. The handle assembly as described in Clause 125, wherein the electrical connector comprises a plurality of pins.

[0458] 127. The handle assembly as described in Clause 126, wherein the electrical components of the handle assembly include 2 to 25 pins.

[0459] 128. The handle assembly according to any one of clauses 126 to 127, wherein the plurality of pins are electrically connected to a plurality of boards of electrical components of the amplifier assembly.

[0460] 129. The handle assembly according to any one of clauses 126 to 128, wherein the plurality of pins are arranged on the handle assembly.

[0461] 130. The handle assembly according to any one of clauses 126 to 129, wherein the plurality of pins are configured in a V-shaped arrangement.

[0462] 131. The handle assembly according to clause 130, wherein the pins located at the apex of the plurality of V-shaped pins are electrically connected to ground.

[0463] 132. The handle assembly according to any one of clauses 128 to 131, wherein the plurality of pins and the plurality of plates are arranged such that an electrical connection to ground is first established when the amplifier assembly is operatively connected to the handle assembly.

[0464] 133. The handle assembly according to any one of clauses 128 to 132, wherein the plurality of pins and the plurality of plates are arranged such that when the amplifier assembly is operatively connected to the handle assembly, an electrical connection to ground is established prior to the establishment of other electrical connections.

[0465] 134. The handle assembly according to any one of clauses 128 to 133, wherein the plurality of pins and the plurality of plates are arranged such that when the amplifier assembly is disconnected from the handle assembly, the electrical connection to ground is the last electrical connection to be disconnected.

[0466] 135. The handle assembly according to any one of clauses 128 to 134, wherein the plurality of pins and the plurality of plates are arranged such that when the amplifier assembly is disconnected from the handle assembly, the electrical connection to ground is disconnected after other electrical connections are disconnected.

[0467] 136. A system for applying pulsating energy, the system comprising:

[0468] Amplifier components as described in any of Clauses 1 to 67; and

[0469] Handle assembly as described in any of Clauses 68 to 135.

[0470] 137. The system according to Clause 136 further includes:

[0471] The console component includes a power source operatively connected to the handle component.

[0472] 138. The system according to Clause 137, wherein the console component further includes a regulator.

[0473] 139. The system described in any of Clauses 137 to 138, wherein the energy source of the control console component is a voltage potential, an electromagnetic potential, or a pressure potential.

[0474] 140. The system according to any one of the provisions 137 to 139, wherein the console component includes a regulator configured to regulate a first energy source from the energy source to a second energy source.

[0475] 141. The system according to Clause 140, wherein the regulator is an active regulator configured to be controlled by an electrical signal.

[0476] 142. The system according to Clause 141, wherein the regulator is a passive regulator configured to preset to a specific output.

[0477] 143. The system according to any one of clauses 137 to 142, wherein the console component further includes a controller configured to:

[0478] Receives input from at least one of the console component, the handle component, and the amplifier component, and

[0479] The configuration of the console component is adjusted at least in part based on the input received.

[0480] 144. The system according to Clause 143, wherein the controller is further configured to receive input from a source outside the system.

[0481] 145. The system according to any one of clauses 143 to 144, wherein the controller is configured to receive input from at least one of: electrocardiogram results, intravascular pressure monitor, blood volume monitor, or imaging system.

[0482] 146. The system according to any one of the provisions 143 to 145, wherein the console component is a first console component, and the system includes a plurality of console components operatively connected.

[0483] 147. A method for applying pulsating energy to tissue, the method comprising:

[0484] Deploy a pulsating balloon catheter system as described in any of clauses 136 to 146, such that it is operatively connected to a tissue-intercepting element of the system adjacent to tissue; and

[0485] The system is engaged by applying energy to the tissue.

[0486] 148. The method according to Clause 147, wherein the tissue-attaching element comprises a distal balloon.

[0487] 149. The method according to any one of the provisions of 147 to 148, wherein the tissue bonding element includes a cardiac tissue bonding element.

[0488] 150. The method according to any one of clauses 147 to 149, wherein the tissue bonding element is operatively connected to the output of the distal waveguide of the amplifier assembly of the system.

[0489] 151. The method of any one of the provisions 147 to 150, wherein the method is a method of performing dynamic balloon angioplasty.

[0490] 152. The method described in any of the provisions 147 to 151, wherein the method is a method for assessing vascular compliance.

[0491] 153. A kit comprising an amplifier assembly as described in any one of clauses 1 to 68.

[0492] 154. The kit as described in Clause 153 also includes the handle assembly as described in any of Clauses 68 to 135.

[0493] 155. The kit described in any of Clauses 153 to 154 also includes the console component described in any of Clauses 137 to 146.

[0494] 156. A kit as described in any of Clauses 153 to 155, wherein one or more components of the kit are reusable.

[0495] 157. The kit as described in Clause 156, wherein the handle assembly is reusable.

[0496] 158. A kit as described in any of Clauses 153 to 157, wherein one or more components of the kit are sterile.

[0497] 159. The kit described in any of the clauses 153 to 158 also includes packaging.

[0498] In at least some of the foregoing embodiments, one or more elements used in the embodiments may be used interchangeably in another embodiment, unless such substitution is technically not feasible. Those skilled in the art will understand that various other omissions, additions, and modifications can be made to the above methods and structures without departing from the scope of the claimed subject matter. All such modifications and variations are intended to fall within the scope of the subject matter defined by the appended claims.

[0499] Those skilled in the art will understand that, in general, the terminology used herein, particularly in the appended claims (e.g., the body of the appended claims), is typically intended as “open-ended” terms (e.g., the term “comprising” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “including” should be interpreted as “including but not limited to,” etc.). Those skilled in the art will further understand that if there is an intent to introduce a specific number of claim statements, that intent will be explicitly stated in the claims, and where such statements are absent, that intent does not exist. For example, to aid understanding, the appended claims below may contain the use of the introductory phrases “at least one” and “one or more” to introduce claim statements. However, the use of such phrases should not be construed as implying that any particular claim containing such introduced claim statements is limited to containing only one embodiment of such a statement by an undefined number of claim statements, even when the same claim includes the introductory phrases “one or more” or “at least one” and phrases such as “undefined number” (e.g., an element of an undefined number should be interpreted as meaning “at least one” or “one or more”); the same applies to the use of references introducing claim statements. Furthermore, even if a specific number of claims is explicitly stated, those skilled in the art will recognize that such a statement should be interpreted as meaning at least the number of claims (e.g., a simple statement of "two statements" without other modifiers means at least two statements, or two or more statements). Additionally, when using conventions such as "at least one of A, B, and C," this construction is generally intended to allow those skilled in the art to understand the meaning of the convention (e.g., "a system having at least one of A, B, and C" will include, but is not limited to, systems having only A, only B, only C, both A and B, both A and C, both B and C, and / or both A, B, and C). When using conventions such as "at least one of A, B, or C," this construction is generally intended to allow those skilled in the art to understand the meaning of the convention (e.g., "a system having at least one of A, B, or C" will include, but is not limited to, systems having only A, only B, only C, both A and B, both A and C, both B and C, and / or both A, B, and C). Those skilled in the art will further understand that any transition words and / or phrases presenting two or more alternative terms, whether in the specification, claims, or drawings, should be understood to include the possibility of including one, any, or both terms. For example, the phrase "A or B" will be understood to include the possibility of including "A" or "B" or "A and B".

[0500] Furthermore, where features or aspects of this disclosure are described in terms of the Markush group, those skilled in the art will recognize that this disclosure is therefore also described in terms of any single member or subgroup of the Markush group.

[0501] As those skilled in the art will understand, for any and all purposes, such as for providing a written description, all scopes disclosed herein also encompass any and all possible subscopes and combinations thereof. Any listed scope can be readily identified as sufficiently descriptive and such that the same scope can be decomposed into at least equal halves, thirds, quarters, fifths, tenths, etc. As a non-limiting example, each scope discussed herein can be readily decomposed into lower thirds, middle thirds, and upper thirds, etc. As those skilled in the art will also understand, all language such as “up to,” “at least,” “greater than,” “less than,” etc., includes the stated number and refers to a scope that can subsequently be decomposed into subscopes as described above. Finally, as those skilled in the art will understand, a scope includes each individual member. Thus, for example, a group having 1-3 items means a group having 1, 2, or 3 items. Similarly, a group having 1-5 items means a group having 1, 2, 3, 4, or 5 items, and so on.

[0502] Although the foregoing invention has been described in some detail by way of illustration and example for the purpose of clarity, it will be apparent to those skilled in the art, based on the teachings of the present invention, that certain changes and modifications may be made thereto without departing from the spirit or scope of the appended claims.

[0503] Therefore, the foregoing only illustrates the principles of the invention. It should be understood that those skilled in the art will be able to design various arrangements, which, although not explicitly described or shown herein, embody the principles of the invention and are included within its spirit and scope. Furthermore, all examples and conditional language described herein are primarily intended to aid the reader in understanding the principles of the invention and the concepts contributed by the inventors to the field, and should be interpreted as not being limited to these specific examples and conditions. Moreover, all statements herein describing the principles, aspects, and embodiments of the invention, as well as specific examples thereof, are intended to cover their structural and functional equivalents. Additionally, it is intended that such equivalents include both currently known equivalents and those developed in the future, i.e., any element developed to perform the same function, regardless of its structure. Furthermore, nothing disclosed herein is intended to be offered to the public, whether or not such disclosure is expressly stated in the claims.

[0504] Therefore, the scope of the invention is not intended to be limited to the exemplary embodiments shown and described herein. Rather, the scope and spirit of the invention are embodied in the appended claims. In the claims, 35 USC §112(f) or 35 USC §112(6) is explicitly defined as being invoked only if the exact phrase “means for…” or the exact phrase “steps for…” is recited at the beginning of such limitation in the claim; if such an exact phrase is not used in the limitation of the claim, then 35 USC §112(f) or 35 USC §112(6) is not invoked.

Claims

1. An amplifier assembly, the assembly comprising: The proximal nasal region, including the distal face; The distal waveguide, including the near-end face; and A diaphragm, sealing between the proximal nose and the distal waveguide, separates the proximal chamber from the distal chamber. The diaphragm is configured as follows: Translation between the distal end face of the proximal nose and the proximal end face of the distal waveguide. The distal surface of the proximal nose portion is attached to the proximal end of the diaphragm, and The near end face of the distal waveguide is attached to the distal end of the diaphragm.

2. The amplifier assembly of claim 1, wherein the diaphragm comprises a shape that conforms to the distal end face of the proximal nose at the proximal end position of the diaphragm and conforms to the proximal end face of the distal waveguide at the distal end position of the diaphragm.

3. The amplifier assembly according to any of the preceding claims, wherein the diaphragm comprises one or more of the following: folds, corrugations, and corrugated bellows.

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

5. The amplifier assembly according to any of the preceding claims, wherein the distal waveguide includes a shape configured to reduce turbulence in the distal region of the diaphragm to the distal waveguide.

6. The amplifier assembly according to any of the preceding claims, wherein the distal waveguide comprises a funnel-shaped geometry.

7. The amplifier assembly according to any of the preceding claims, wherein the proximal nose includes a proximal interface located at a proximal region of the proximal nose.

8. The amplifier assembly of claim 7, wherein the near-end interface includes a high-voltage connector.

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

10. The amplifier assembly according to any of the preceding claims further includes a pressure sensor configured to sense fluid pressure within the distal waveguide.

11. The amplifier assembly of claim 10, wherein the pressure sensor is integrated into the distal waveguide.

12. The amplifier assembly according to any of the preceding claims further includes a sensor configured to sense the position of the diaphragm.

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

14. The amplifier assembly according to any of the preceding claims, wherein the amplifier assembly further comprises a balloon catheter operatively connected to the distal waveguide.

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

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

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

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

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

20. A method comprising operatively connecting an amplifier assembly according to claim 14 to an energy source.

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

22. The method according to any one of claims 17 to 18, wherein the method further comprises positioning the balloon of the balloon catheter near the tissue.

23. The method of claim 19, wherein the method further comprises applying energy to the tissue.

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