Tissue treatment system

Abstract

A system for administering medical procedures to patients is provided. [Solution] The system includes at least one of an energy delivery device, a long-term energy delivery device, and / or a power supply device. In particular, the system may be configured to treat and / or diagnose patients suffering from sleep apnea. Methods and apparatus for treating sleep apnea and other medical conditions are also provided.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 195,292 ( docket number USD - 004 - PR1) titled "Tissue Interface System", filed on June 1, 2021, the content of which is hereby incorporated by reference in its entirety for all purposes.

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 286,161 ( docket number USD - 008 - PR1) titled "Capacitive Micromachined Ultrasonic Transducer", filed on December 6, 2021, the content of which is hereby incorporated by reference in its entirety for all purposes.

[0003] This application is related to U.S. Provisional Patent Application No. 62 / 728,616 ( docket number USD - 001 - PR) titled "Medical Device with CMUT Array and Solid State Cooling, and Associated Methods and Systems - with Thermal Analysis", filed on September 7, 2018, the content of which is hereby incorporated by reference in its entirety for all purposes.

[0004] This application is related to U.S. Application No. 16 / 130,896 ( docket number USD - 001 - US) titled "Medical Device with CMUT Array and Solid State Cooling, and Associated Methods and Systems", filed on September 13, 2018, and U.S. Patent No. 11,154,730, issued on October 26, 2021, the content of which is hereby incorporated by reference in its entirety for all purposes.

[0005] This application relates to U.S. Patent Application No. 17 / 479,011 (reference number USD-001-US-CON1), filed on September 20, 2021, entitled "Medical Device with CMUT Array and Solid State Cooling, And Associated Methods and Systems," and to U.S. Publication No. US2022 / 0072338, published on March 10, 2022, the contents of which are incorporated herein by reference in their entirety for all purposes.

[0006] This application relates to International PCT Patent Application No. PCT / US2018 / 050943 (Reference Number USD-001-PCT), filed on 13 September 2018, entitled "Medical Device with CMUT Array and Solid State Cooling, and Associated Methods and Systems," and Publication No. WO2019 / 055699, published on 21 March 2019, the contents of which are incorporated by reference in their entirety for all purposes.

[0007] This application relates to U.S. Provisional Patent Application No. 63 / 126,078 (reference number USD-003-PR1) filed on 16 December 2020, entitled “Tissue Interface System,” the contents of which are incorporated herein by reference in their entirety for all purposes.

[0008] This application is International PCT Patent Application No. PCT / US2021 / 063743 (Reference Number USD-003-PCT), filed on 16 December 2021, entitled "Tissue Interface System," relating to International Publication No. 2022 / 133054, published on 23 June 2022, the contents of which are incorporated herein by reference in their entirety for all purposes.

[0009] Technical field Embodiments disclosed herein generally relate to systems for performing medical procedures on patients, and more particularly to systems for delivering ultrasonic energy to the patient's tissues to perform diagnostic and / or therapeutic procedures. [Background technology]

[0010] Many medical devices require the delivery of energy to a patient to collect imaging data or to treat tissue. Improved systems, devices, and methods are needed for delivering energy to diagnose or treat a patient's illnesses and ailments. [Prior art documents] [Patent Documents]

[0011] [Patent Document 1] International Publication No. 2018 / 005511 [Overview of the Initiative] [Means for solving the problem]

[0012] According to one aspect of the concept of the present invention, a system for performing a medical procedure on a patient includes at least one of an energy delivery device, a long-term energy delivery device, and / or a power supply device.

[0013] In some embodiments, the medical procedure includes a diagnostic procedure, a therapeutic procedure, or both a diagnostic procedure and a therapeutic procedure.

[0014] In some embodiments, the system includes two or more of the following: an energy delivery device, a long-term energy delivery device, and / or a power supply device.

[0015] In some embodiments, the system is configured to diagnose and / or treat patients with sleep apnea. The system may include two or more of the following: an energy delivery device, a long-term energy delivery device, and / or a power supply device.

[0016] In some embodiments, the system is configured to excise the patient's target tissue while avoiding damage to the patient's non-target tissue.

[0017] In some embodiments, the system includes an array of ultrasonic transducers having one, two, or more ultrasonic transducers. The array of ultrasonic transducers may include at least one piezoelectric element, at least one CMUT element, and / or at least one piezoelectric element and at least one CMUT element.

[0018] In some embodiments, the system further includes a controller and a memory storage component coupled to the controller, the memory storage component storing instructions for executing an algorithm. The algorithm may include an artificial intelligence algorithm. The algorithm may be configured to allow the system to identify target tissue for ablation. The algorithm may be configured to distinguish between target and non-target tissue.

[0019] The technologies described herein, along with their attributes and associated advantages, will be best recognized and understood by considering the following detailed description in conjunction with the accompanying drawings, which illustrate representative embodiments.

[0020] Reference All publications, patents, and patent applications referenced in this specification are referred to by reference to the same extent as each individual publication, patent, or patent application is specifically and individually referred to. [Brief explanation of the drawing]

[0021] [Figure 1] This invention presents a system for treating and / or diagnosing tissue, consistent with the concept of the present invention. [Figure 2] This is a flowchart of a method for providing treatment in a closed-loop configuration, consistent with the concept of the present invention. [Figure 3]A flowchart of a method for treating a patient that is consistent with the concepts of the present invention. [Figure 4] A side cross-sectional anatomical view of a long-term energy delivery device implanted in a patient for stimulating a nerve, which is consistent with the concepts of the present invention. [Figure 5] A side cross-sectional anatomical view of a long-term energy delivery device implanted in a patient for stimulating a nerve, which is consistent with the concepts of the present invention. [Figure 6A] A side cross-sectional anatomical view of a force supply device implanted in a patient for applying force to tissue, which is consistent with the concepts of the present invention. [Figure 6B] A side cross-sectional anatomical view of a force supply device implanted in a patient for applying force to tissue, which is consistent with the concepts of the present invention. [Figure 7] A partially transparent anatomical view of a force supply device implanted in a patient for applying force to tissue, which is consistent with the concepts of the present invention. [Figure 8] A cross-sectional anatomical view of an energy delivery device for delivering energy to tissue, which is consistent with the concepts of the present invention. [Figure 9] A side view of an energy delivery device for delivering energy to tissue captured by the device, which is consistent with the concepts of the present invention. [Figure 10] A perspective view of an energy delivery device for delivering energy to tissue captured by the device, which is consistent with the concepts of the present invention. [Figure 11] A perspective view of an energy delivery device for delivering energy to tissue captured by the device, which is consistent with the concepts of the present invention. [Figure 12] A side cross-sectional anatomical view of an energy delivery device disposed on the skin under the patient's jaw for delivering energy to tongue tissue, which is consistent with the concepts of the present invention. [Figure 13] A side cross-sectional anatomical view of an energy delivery device advanced nasally for placing a transducer within the patient's airway, which is consistent with the concepts of the present invention. [Figure 14] A front anatomical view of an energy delivery device disposed on the patient's face, which is consistent with the concepts of the present invention. [Figure 15]A perspective view is shown of a system including an energy delivery device, consistent with the concept of the present invention, which comprises a shaft and a transducer located distal to the shaft and having a diameter close to the diameter of the shaft. [Figure 16] A perspective view is shown of a system including an energy delivery device, consistent with the concept of the present invention, which comprises a shaft and a transducer located distal to the shaft and having a diameter larger than the diameter of the shaft. [Figure 17] A side cross-sectional anatomical view of an energy delivery device, including an energy delivery module and mirrors, consistent with the concept of the present invention, is shown. [Figure 18A] A top view of an energy delivery device consistent with the concept of the present invention is shown. [Figure 18B] A cross-sectional anatomical diagram of an energy delivery device, consistent with the concept of the present invention, is shown. [Figure 19] This diagram shows a lateral cross-sectional anatomical view of an energy delivery device inserted transnasally into a patient, consistent with the concept of the present invention. [Modes for carrying out the invention]

[0022] Next, embodiments of the present technology will be referred to in detail, and examples thereof will be shown in the accompanying drawings. Similar reference numerals will be used to refer to similar components. However, this description is not intended to limit the present disclosure to any particular embodiment, but should be construed as including various modifications, equivalents, and / or substitutes of the embodiments described herein.

[0023] Certain features of the present invention are described in the context of separate embodiments for clarity, but it will be understood that they may also be provided in combination in a single embodiment. Conversely, various features of the present invention are described in the context of a single embodiment for brevity, but they may also be provided separately or in any suitable subcombination. For example, it will be understood that all features described in any of the claims (whether independent or dependent) may be combined in any given way.

[0024] At least portions of the drawings and description of this invention have been simplified to focus on elements relevant to a clear understanding of the invention, but it should be understood that, for clarity, the omission of other elements that would be understood by those skilled in the art may also be part of the invention. However, since such elements are well known in the art and do not necessarily facilitate the understanding of the invention, a description of such elements is not provided herein.

[0025] The terms defined herein are used solely to describe specific embodiments of the disclosure and are not intended to limit the scope of the disclosure. Terms provided in the singular form are intended to include the plural form unless explicitly indicated otherwise in the context. All terms used herein, including technical or scientific terms, have the same meaning as commonly understood by those skilled in the art unless otherwise defined herein. Terms defined in commonly used dictionaries should be interpreted as having the same or similar meaning as their meaning in the context of the relevant technology, and not as having an ideal or exaggerated meaning unless expressly defined herein. In some cases, terms defined herein should not be interpreted as precluding embodiments of the disclosure.

[0026] Where used herein, “comprising” (and any form of “comprising,” e.g., “comprise” and “comprises”), “having” (and any form of “having,” e.g., “have” and “has”), “including” (and any form of “including,” e.g., “includes” and “include”), and / or “containing” (and any form of “containing,” e.g., “contains” and “contain”) identify the presence of a described feature, integer, step, operation, element, and / or component, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0027] The terms First, Second, Third, etc., may be used herein to describe various limitations, elements, components, areas, layers, and / or sections, but it will be further understood that these limitations, elements, components, areas, layers, and / or sections should not be limited by these terms. These terms are used solely to distinguish one limitation, element, component, area, layer, or section from another limitation, element, component, area, layer, or section. Accordingly, the First limitation, element, component, area, layer, or section described below may be referred to as the Second limitation, element, component, area, layer, or section without departing from the disclosure of this application.

[0028] When an element is described as being "on top of," "attached," "connected," or "joined" to another element, it will be further understood that it may be directly on top of or above the other element, or connected to or joined to the other element, or that one or more intervening elements may be present. In contrast, when an element is described as being "directly on top of," "directly attached," "directly connected," or "directly joined" to another element, there are no intervening elements. Other words used to describe the relationship between elements should be interpreted similarly (e.g., "between" and "directly between," "adjacent" and "directly adjacent").

[0029] When the first element is referred to as being "inside," "on top of," and / or "inside" the second element, it will be further understood that the first element may be located within the internal space of the second element, within a portion of the second element (e.g., within the walls of the second element), on the outer surface and / or inner surface of the second element, and two or more combinations thereof.

[0030] As used herein, the term “proximity” should be interpreted as including one or more locations close to the second component or location, as well as locations within, above, and / or within the second component or location, when used to describe the proximity between a first component or location and a second component or location. For example, a component located in proximity to an anatomical site (e.g., a target tissue location) includes components located near the anatomical site, as well as components located within, above, and / or within the anatomical site.

[0031] Spatial relative terms, such as “down,” “below,” “bottom,” “up,” and “top,” may be used to describe the relationship of an element and / or feature to another element and / or feature, as shown in the drawings, for example. It will be further understood that spatial relative terms are intended to encompass different orientations of the device in use and / or operation, in addition to the orientation shown in the drawings. For example, if the device in the drawing is turned over, an element described as “below” and / or “below” another element or feature may then be oriented “up” the other element or feature. The device may be oriented in other ways (e.g., rotated 90° or to another orientation), and the spatial relative descriptors used herein will be interpreted accordingly.

[0032] As used herein, terms such as “reduce,” “decrease,” and “decrease” include reductions in quantity, including reductions to zero. Reducing the likelihood of occurrence includes prevention of occurrence. Similarly, as used herein, terms such as “prevent,” “prevent,” and “reduction” include the actions of “reduce,” “decrease,” and “mitigation,” respectively.

[0033] As used herein, the terms “and / or” should be interpreted as specific disclosures of each of the two designated features or components, with or without the other. For example, “A and / or B” should be interpreted as specific disclosures of (i) A, (ii) B, and (iii) A and B, as if each were described separately herein.

[0034] As used herein, the term “one or more” may mean any number, from one, two, three, four, five, six, seven, eight, nine, ten, or more.

[0035] The terms “and their combinations” and “and these combinations” may, in this specification, be used after a list of items that are included individually or collectively. For example, a combination of a component, process, and / or other item selected from the group consisting of A, B, and C shall include one, two, three or more of item A, one, two, three or more of item B, and / or one, two, three or more of item C.

[0036] In this specification, unless otherwise specified, “and” may mean “or,” and “or” may mean “and.” For example, if a feature is described as having A, B, or C, that feature may have A, B, and C, or any combination of A, B, and C. Similarly, if a feature is described as having A, B, and C, that feature may have only one or two of A, B, or C.

[0037] As used in this disclosure, the expression “configured (or set up)” may be used interchangeably, depending on the context, with expressions such as “suitable for,” “capable of,” “designed for,” “adapted for,” “made for,” and “capable of.” The expression “configured (or set up)” does not mean that the hardware is “specifically designed for.” Alternatively, depending on the context, the expression “device configured for” may mean that the device “can” operate with another device or component.

[0038] As used herein, the term “threshold” refers to the maximum level, minimum level, and / or range of values ​​that correlate to a desired or undesirable state. In some embodiments, system parameters are maintained above a minimum threshold, below a maximum threshold, within a threshold range of values, and / or outside a threshold range of values ​​to produce, for example, a desired effect (e.g., effective treatment) and / or prevent or otherwise reduce (hereinafter, “prevent”) an undesirable event (e.g., device and / or clinical adverse event). In some embodiments, system parameters are maintained above a first threshold (e.g., above a first temperature threshold to produce a desired therapeutic effect on tissue) and below a second threshold (e.g., below a second temperature threshold to prevent undesirable tissue damage). In some embodiments, thresholds are determined to include a safety margin, for example, patient variability, system variability, tolerance, etc. As used herein, “above a threshold” means that the parameter is above a maximum threshold, below a minimum threshold, within a threshold range, and / or outside a threshold range.

[0039] As used herein, “chamber pressure” means the pressure of the environment surrounding the system and apparatus of the concept of the present invention. “Positive pressure” includes pressure above the chamber pressure, or simply pressure greater than another pressure, such as a positive differential pressure across fluid path components such as valves. “Negative pressure” includes pressure below the chamber pressure, or pressure less than another pressure, such as a negative differential pressure across fluid path components such as valves. Negative pressure may include a vacuum, but does not mean pressure below a vacuum. As used herein, the term “vacuum” may be used to mean a complete vacuum, a partial vacuum, or any negative pressure as described above.

[0040] The term “diameter” is used herein to describe non-circular geometric shapes and should be interpreted as the diameter of a hypothetical circle approximating the geometric shape being described. For example, when describing a cross-section, such as the cross-section of a component, the term “diameter” is interpreted to represent the diameter of a hypothetical circle having the same cross-sectional area as the cross-section of the component being described.

[0041] As used herein, the terms “major axis” and “minor axis” of a component refer to the length and diameter of a hypothetical cylinder with the smallest volume that can completely enclose the component, respectively.

[0042] As used herein, the term “fluid” may refer to a liquid, gas, gel, or any fluid substance, such as a substance that can be propelled through a lumen and / or opening.

[0043] As used herein, the term “substance” may refer to a single substance or a combination of two, three, four, or more substances.

[0044] As used herein, the term “transducer” should be interpreted to include any component or combination of components that receive energy or any input and produce an output. For example, a transducer may include electrodes that receive electrical energy and distribute that electrical energy to tissue (e.g., based on the size of the electrodes). In some configurations, a transducer converts an electrical signal into any output, such as light (e.g., a transducer including a light-emitting diode or light bulb), sound (e.g., a transducer including one or more piezoelectric transducers and / or a CMUT transducer configured to transmit and / or receive ultrasonic energy), pressure (e.g., applied pressure or force), thermal energy, cryogenic energy, chemical energy, mechanical energy (e.g., a transducer including a motor or solenoid), magnetic energy, and / or a different electrical signal (e.g., different from the input signal to the transducer). Alternatively or additionally, a transducer may convert a physical quantity (e.g., a change in a physical quantity) into an electrical signal. A transducer may include any components that deliver energy and / or activators to tissue, and is configured to deliver, for example, thermal energy, cryogenic energy, electrical energy (such as a transducer including one or more electrodes), optical energy (such as a transducer including a laser, light-emitting diode, and / or optical components such as a lens or prism), mechanical energy (such as a transducer including a tissue manipulating element), sound energy (such as a transducer including one or more piezoelectric transducers and / or CMUT transducers), chemical energy, electromagnetic energy, magnetic energy, and two or more combinations thereof. Alternatively or additionally, a transducer may include mechanisms, for example, valves, gripping elements, fixing mechanisms, electrically actuated mechanisms, mechanically actuated mechanisms, and / or thermally activated mechanisms.

[0045] As used herein, the term “functional element” should be interpreted as comprising one or more elements constructed and arranged to perform a function. A functional element may include one or more sensors and / or one or more transducers. In some embodiments, a functional element is configured to deliver energy and / or treat tissue (e.g., a functional element configured as a therapeutic element). Alternatively or additionally, a functional element (e.g., including one or more sensors) may be configured to record one or more parameters, e.g., a patient’s physiological parameters, a patient’s anatomical parameters (e.g., tissue parameters), a patient’s environmental parameters, and / or system parameters (e.g., temperature and / or pressure within a system). In some embodiments, a sensor or other functional element is configured to perform a diagnostic function (e.g., to collect data used to perform a diagnosis). In some embodiments, a functional element is configured to perform a therapeutic function (e.g., to deliver therapeutic energy and / or therapeutic drugs). In some embodiments, a functional element comprises one or more elements constructed and arranged to perform a function selected from the following groups: delivering energy, extracting energy (e.g., to cool components), delivering drugs or other agents, manipulating system components or patient tissue, recording or sensing parameters such as patient physiological parameters or patient anatomical parameters, and two or more combinations thereof. A “functional assembly” may include an assembly constructed and arranged to perform the functions described above. In some embodiments, a functional assembly is configured to deliver energy and / or treat tissue (e.g., a functional assembly configured as a therapeutic assembly). Alternatively or additionally, a functional assembly may be configured to record one or more parameters such as patient physiological parameters, patient anatomical parameters, patient environmental parameters, and / or system parameters. A functional assembly may include an expandable assembly. A functional assembly may include one or more functional elements.

[0046] As used herein, the term “Agent” includes, but is not limited to, one or more agents selected from the following groups, which are agents, drugs (e.g., pharmaceuticals), hormones, proteins, protein derivatives, small molecules, antibodies, antibody derivatives, excipients, reagents, buffers, vitamins, dietary supplements, and combinations thereof, configured to improve and / or maintain the health of a patient.

[0047] As used herein, the term “target tissue” includes one or more volumes of the tissue of the patient being diagnosed and / or treated. Similarly, “therapeutic target” or “tissue target” includes one or more volumes of the tissue being diagnosed and / or treated. “Safety margin tissue” includes tissue whose treatment (e.g., receiving excision energy) will not have a significant adverse effect on the patient. “Non-target tissue” includes tissue that is not intended to be treated (e.g., not intended to receive energy). In some embodiments, “target tissue,” “therapeutic target,” and / or “tissue target” include non-tissue material, such as pigment particles used in tattoos, fragments such as wood or metal pieces, and / or other undesirable material present in the patient’s body.

[0048] As used herein, the term “system parameter” includes one or more parameters of the system of the concept of the present invention. A system parameter may include one or more “energy delivery parameters” (also referred to as “energy delivery settings”), one, two or more energy delivery parameters selected from a group consisting of, for example, energy form (e.g., ultrasound, light, electromagnetic waves), amplitude, frequency, waveform shape, pulse width modulation parameter, time division multiplexing parameter, pulse width, pulse velocity, duty cycle, energy beam region (e.g., ultrasound beam and / or light beam), energy delivery location, tissue temperature such as the starting temperature of the tissue before treatment, other energy delivery parameters, and combinations thereof. A system parameter may include parameters selected from a group consisting of energy delivery parameters, pressure level, temperature level, energy level, frequency level, amplitude level, battery level, and combinations thereof. A system parameter may include one or more tissue targets identified as targets for treatment (e.g., the volume of tissue intended to be excised and / or stimulated), such as tissue targets identified for treatment by the system’s algorithm.

[0049] As used herein, the term “patient parameter” includes one or more parameters related to a patient. Patient parameters may include physiological parameters of the patient, such as temperature (e.g., tissue temperature), pressure (e.g., blood pressure or other fluid pressures), pH, blood gas parameters, blood glucose levels, hormone levels, heart rate, respiratory rate, and combinations thereof, selected from a group. Alternatively or additionally, patient parameters may include environmental parameters of the patient, such as the patient’s geographical location, temperature, pressure, humidity level, light level, time of day, and combinations thereof, selected from a group.

[0050] As used herein, the term “image data” includes data produced by one or more imaging devices. Image data may include data relating to target tissue, safety margin tissue, and non-target tissue. Image data may also include data relating to any implants or other non-tissue objects adjacent to the tissue being imaged. Image data can be processed by one or more algorithms of the concept of the present invention to determine, for example, one or more locations to be treated (e.g., target tissue identified to be excised or to receive energy) and / or one or more locations (e.g., non-target tissue) to which energy delivery should be avoided. Image data may include data generated by a single imaging component or from multiple imaging components.

[0051] As used herein, the term “transmit a signal” and its derivatives refer to the transmission of power and / or data in any direction between two or more components.

[0052] As used herein, the term “patient use data” refers to data relating to the use of the tissue interface system of the Concept of the Invention on a patient (e.g., the use of the system in a diagnostic and / or therapeutic procedure performed on the patient). The data may include, but is not limited to, operational parameters such as energy delivery parameters and the duration of energy delivery; target tissue parameters such as the location and / or volume of target tissue; patient parameters such as the patient’s physiological parameters and / or the patient’s location or other patient environment parameters; clinician parameters; clinical setting parameters; and combinations thereof. Patient use data may include data from multiple patients, for example, data collected from multiple patients interface with one or more systems of the Concept of the Invention. In some embodiments, the algorithm of the Concept of the Invention uses patient use data from one or more patients to determine system parameters to be used when performing a medical procedure on a patient.

[0053] As used herein, the term “conduit” or “conduit”(plural) can mean an elongated component which may include one or more flexible and / or nonflexible filaments selected from the following groups: one or more wires or other conductors (e.g., including an outer insulator), one or more waveguides, one, two or more hollow tubes, e.g., hydraulic, pneumatic and / or other fluid delivery tubes, one or more optical fibers, one or more control cables and / or other mechanical links, one or more flexible circuits, and combinations thereof. A conduit may include a tube which contains multiple conduits arranged inside the tube. A conduit may be configured to connect one component to another electrically, fluidly, acoustically, optically, mechanically and / or otherwise operably.

[0054] As used herein, a component is considered an “implantable” component, or a component “implanted” in the patient, if it is located at any location beneath the patient’s skin (e.g., within the patient’s tissue, within the patient’s airway, and / or within the patient’s airway, and other internal locations). Implantable devices may be implanted in the patient via a surgical procedure (e.g., a procedure involving an incision in the patient’s skin), and / or devices may be implanted via delivery through a natural opening (e.g., mouth, eyes, nostrils, external auditory canal, anal opening, urethral opening, vagina, and / or pores of the skin).

[0055] As used herein, “ultrasonic transducer” (also called “ultrasonic element”) may mean one or more components configured to transmit ultrasonic energy (for example, based on a transmitted electrical signal), and / or one or more components configured to receive ultrasonic energy (and for example to convert it into an electrical signal). An ultrasonic transducer may include one or more sets of ultrasonic transducers, e.g., a 1D or 2D array of ultrasonic transducers. An ultrasonic transducer may mean one or more sets of piezoelectric transducers (also called “piezo” transducers or elements), one or more sets of capacitive micromachined ultrasonic transducers (CMUTs), or one or more sets of both.

[0056] As used herein, “optical transducer” (also called “optical element”) may mean one or more components configured to transmit light (e.g., a diode such as a laser diode) and / or one or more components configured to receive and / or facilitate the propagation of light (e.g., a lens, a prism, an optical fiber, etc.).

[0057] A system of the concept of the present invention may be configured to deliver energy to treat and / or diagnose one or more medical conditions in a patient using one or more energy delivery modules. Energy delivery modules of the concept of the present invention may include modules configured to deliver and / or receive various forms of energy, such as ultrasonic energy. In some embodiments, an array of one, two or more piezoelectric transducers and / or an array of one, two or more CMUTs may be included to deliver ultrasonic energy (e.g., to stimulate, excise, and / or affect tissue) and / or to receive reflected ultrasonic energy (e.g., to image tissue, such as when the same and / or different elements deliver the energy that is reflected and received).

[0058] Referring here to Figure 1, a schematic diagram of a tissue interface system consistent with the concept of the present invention is shown. System 10 may be configured to perform medical procedures on a patient. Medical procedures performed using System 10 may include one or more clinical procedures (also referred to herein as “medical procedures”), e.g., the performance of one or more diagnostic procedures and / or one or more therapeutic procedures performed on a patient. System 10 may be configured to diagnose and / or treat one or more medical conditions (such as diseases and / or disorders) of a patient. System 10 may be configured to treat and / or diagnose one or more portions (e.g., volumes) of patient tissue, referred herein as “target tissue”. In some embodiments, System 10 includes one or more devices configured to deliver one or more forms of energy to the target tissue, e.g., to stimulate, modulate, excise, and / or otherwise treat the target tissue. Alternatively or additionally, System 10 may include one or more devices configured to generate image data IDs which may include image data, image data of tissue and / or one or more objects adjacent to the tissue. Image data IDs may include tissue or other object image data used in determining a diagnosis and / or prognosis (either or both of which are "diagnosis" in this specification). Alternatively or additionally, image data IDs may include tissue or other object image data used in tissue therapeutic procedures (e.g., stimulation, excision, and / or other tissue therapeutic procedures to guide or otherwise influence them). Image data IDs may include image data related to target tissue, safety margin tissue, non-target tissue, implantable diagnostic and / or therapeutic devices, foreign bodies (e.g., fragments, tattoos, etc.), and combinations thereof. System 10 may be configured to generate image data IDs through the delivery of energy, e.g., delivered sound energy and / or light energy, and to collect the reflection thereof to generate image data IDs, as described herein. In some embodiments, image data IDs may include data related to tissue, including blood, for example, when image data IDs include blood flow data (e.g., obtained using Doppler ultrasound).In some embodiments, the image data ID includes tissue temperature information (e.g., one or more temperature readings for one or more volumes of tissue) and / or tissue ablation information (e.g., completion of ablation information for one or more volumes of tissue).

[0059] As used herein, “tissue diagnostic procedure,” “tissue diagnostic,” and their derivatives include, but are not limited to, the delivery of energy for collecting image data IDs (e.g., when System 10 records the reflection of delivered ultrasound, light, or other energy and converts these recordings into image data IDs), the delivery of energy to tissue for characterizing the tissue (e.g., when System 10 records one or more effects on the tissue by energy delivery, such as using spectroscopy), and / or the recording of one or more tissue characteristics using one or more sensors of System 10. In some embodiments, the tissue diagnostic performed by System 10 includes a diagnosis of tissue, e.g., the level of tissue ablation (e.g., volume of target and / or non-target tissue), tissue temperature, tissue elasticity, tissue density, and / or tissue type (e.g., fat, nerve, muscle, and / or other tissue types in a given volume of tissue). In some embodiments, System 10 utilizes machine learning or other AI algorithms (e.g., as described herein) to perform the tissue diagnostic procedure (e.g., to assess the level of tissue ablation).

[0060] As used herein, “tissue therapeutic procedure,” “tissue therapy,” and their derivatives include, but are not limited to, tissue ablation, tissue removal, induction of tissue necrosis, reduction of tissue volume (e.g., tissue weight loss), tissue stimulation, improvement of the strength of tissue (e.g., muscle tissue), scaffolding of tissue and / or airways, manipulation and / or supply of force to tissue, tissue hardening, and / or otherwise providing a therapeutic effect to tissue. As used herein, “tissue reduction procedure” or “tissue reduction,” and their derivatives include tissue therapeutic procedures that reduce the volume of a portion of tissue (e.g., target tissue), which include, for example, tissue ablation, tissue lithotripsy, tissue lithotripsy, tissue removal, tissue liquefaction (e.g., liquefaction of adipose tissue), induction of tissue necrosis, tissue weight loss, and / or otherwise causing a reduction in tissue volume (e.g., within a day, a week, and / or a month of treatment). In some embodiments, tissue reduction procedures include procedures that deform tissue (e.g., deform the geometric shape of the tissue volume), for example, reducing the volume of tissue present in the airway without necessarily reducing the overall volume of the tissue. As used herein, “tissue augmentation procedures” or “tissue augmentation,” and their derivatives, include tissue treatment procedures in which a portion of tissue (such as muscle tissue or other tissue) is strengthened, hardened, tightened, tensed, moved (e.g., to a better position), and / or otherwise augmented, for example, augmentation used to mitigate one or more adverse effects of a patient’s illness or disorder (such as sleep apnea), and / or augmentation used in cosmetic procedures (e.g., to reduce wrinkles and / or to improve a patient’s appearance). Tissue augmentation procedures may include the delivery of energy (such as ultrasound energy) for nerve modulation. Tissue augmentation procedures may include the delivery of energy (such as ultrasound energy) configured to excise specific tissue (such as tongue tissue) in order to strengthen adjacent muscle tissue (e.g., to strengthen the muscle tissue of the tongue).

[0061] Where used herein, “treatment plan” includes a set of parameters used when treating a patient’s target tissue using System 10. A treatment plan may include a set of energy delivery settings, e.g., the level or form of energy delivery, the location of energy delivery, and / or other energy delivery parameters as defined herein. A treatment plan may include a set of different medical procedures (e.g., one or more different medical procedures such as tissue reduction, tissue augmentation, tissue force supply, drug therapy, CPAP therapy, and / or other procedures). A treatment plan may include a desired and / or recommended sequence for performing a set of multiple medical procedures (e.g., where the treatment plan provides multiple procedures to be performed in a specific order, in some examples where sufficient efficacy is achieved when a subset of the medical procedures are performed). In some embodiments, System 10 is configured to generate treatment plans (e.g., one or more treatment plans available to a clinician) automatically and / or semi-automatically ("automatically" as used herein). System 10 may generate treatment plans using algorithms such as algorithm 50 described herein. The treatment plan may be developed by algorithm 50 using image data IDs, for example, by using image data IDs including ultrasound-based image data (such as Doppler data and / or other image data generated using ultrasound), CT-based image data, MRI-based image data, and / or X-ray-based image data (such as fluoroscopy data and / or other image data generated using X-rays). Alternatively or additionally, algorithm 50 may develop the proposed treatment plan based on parameters selected from the following groups: the patient's age, the volume of the target tissue to be resected, reduced in volume, and / or otherwise treated (e.g., if the target tissue includes tumor tissue, adenoid tissue, tongue tissue, tonsil tissue, and / or other tissue), the fat content of the target tissue, the geometric shape of the target tissue, the tissue type, geometric shape, and / or other characteristics of non-target tissue adjacent to the target tissue, the geometric shape of the airway adjacent to the target tissue, and combinations thereof.In some embodiments, the treatment plan includes a methodology for ensuring treatment of the target tissue while avoiding damage to adjacent non-target tissue. In some embodiments, the system 10 is configured (e.g., via algorithm 50) to generate predictions of outcomes associated with one or more treatment plans (e.g., estimates of potential effectiveness and / or assessments of risks). For example, algorithm 50 may be configured to analyze data from multiple patient populations, e.g., patients with similar tissue configurations (e.g., similar tissue geometric shapes related to the impact on sleep apnea events).

[0062] System 10 may include EDD100, which includes one, two, or more energy delivery devices used by physicians, nurses, and / or medical technicians (hereinafter referred to as “clinicians”) to diagnose and / or treat patients through the delivery of energy in medical procedures. System 10 includes multiple energy delivery devices such as EDD100, 100', and / or 100” (generally EDD100) as shown in the illustration. The EDD100 may include a device. During its medical use (such as a diagnostic and / or therapeutic use), one or more energy delivery portions of the EDD100 are positioned at one or more locations on the patient, or at a location close to the patient, in this specification at location L100, and target tissue close to location L100 can be diagnosed and / or treated by the EDD100 via delivery of one or more forms of energy as described herein. In some embodiments, the EDD100 is configured to receive one or more forms of energy, e.g., reflected energy used to generate image data IDs, and / or energy representing control signals or other data transmitted to the EDD100 (e.g., wirelessly). The EDD100 may include a handheld device, a catheter, a probe (e.g., a probe configured to be inserted through a laparoscopic port), and / or a robotic control device. In some embodiments, the EDD100 includes a plurality of separate components. The EDD100 includes one or more housings, housing 101 in the illustration, for example, one or more housings surrounding one or more components of the EDD100.

[0063] System 10 may include CEDD200, which may include one, two or more Chromic Energy Delivery Devices, which may be implanted in, positioned, and / or provided to the patient, so that the patient's diagnosis and / or treatment can be performed continuously (for example, for periods of at least one week, at least one month, at least three months, and / or at least six months). System 10 may include a plurality of long-term energy delivery devices, such as CEDD200, 200', and / or 200” (generally CEDD200) as shown in the illustration. In a medical application, one or more energy delivery portions of CEDD200 are located inside, on, and / or in close proximity to a patient, in this specification, at location L200, so that target tissue in close proximity to location L200 can be diagnosed and / or treated by CEDD200 via delivery of one or more forms of energy, as described herein. The energy may be delivered by CEDD200 relatively continuously and / or intermittently, also as described herein. In some embodiments, CEDD200 is configured to receive one or more forms of energy, e.g., reflected energy used to generate image data IDs, or energy representing control signals and / or other data transmitted to CEDD200 (e.g., wirelessly). CEDD200 includes one or more housings, in the illustration, housing 201, for example, one or more housings surrounding one or more components of CEDD200.

[0064] The CEDD200 may include one or more distinct components, for example, one or more components positioned outside but in close proximity to the patient's skin during use, and / or one or more components implanted within the patient (e.g., in the airway). In some embodiments, the CEDD200 includes a first component containing an EDM250 to deliver energy to tissue (e.g., to perform imaging procedures and / or therapeutic actions), and a second component configured to supply power to the first component, for example, via a wired or wireless connection. For example, the CEDD200 may include a first component implanted in the patient and a second component positioned on the patient's skin in close proximity to the implantation site of the first component (during use) (as illustrated, for example, with reference to Figure 4). In some embodiments, the CEDD200 may include a first component implanted in the patient, the first component comprising an EDM250 configured to deliver energy to tissue (e.g., to perform imaging procedures and / or therapeutic actions), and a second component also implanted in the patient and configured to supply power to the first component, for example, via a wired or wireless connection (as illustrated, for example, with reference to Figure 5 of this specification). In these embodiments, the CEDD200 may include a third component located outside the patient's body, for example, the third component supplying power to the first component and / or the second component (e.g., via wireless energy transfer). CEDD200 includes components arranged as flexible sheets and / or tubular structures that can be wrapped around a nerve and / or positioned along a nerve, for example, components including an array of piezoelectric transducers and / or CMUTs (such as tubes and / or wraps of piezoelectric transducers and / or CMUTs) that can receive ultrasonic energy (from a second component of CEDD200, for example), convert the ultrasonic energy into electrical energy, which is then delivered to the tissue (for example, via one or more electrodes as described herein with reference to Figures 4-5).In these embodiments, the array of ultrasonic transducers receiving ultrasonic energy can be configured as a relatively omnidirectional assembly, so that the ultrasonic energy can be successfully delivered from multiple locations (for example, sensitivity to the location of the components delivering the ultrasonic energy is significantly reduced).

[0065] In some embodiments, the CEDD200 is configured to deliver energy (such as ultrasound energy) via the EDM250 and collect image data IDs associated with target tissue that further receives energy (such as stimulation energy) from the EDM250. The energy delivered by the EDM250 to generate the image data IDs (e.g., via reflection of delivered energy received by the EDM250) and the stimulation energy delivered by the EDM250 can take the same path (e.g., the same path of ultrasound or other energy through the tissue). In these embodiments, the stimulation energy can be delivered in a closed-loop configuration based on the collected image data IDs (e.g., the EDM250 continuously switches between imaging mode and stimulation mode). This closed-loop configuration can enhance the effectiveness of the stimulation, for example, when stimulating airway tissue to treat sleep apnea, adjustments in the trajectory of stimulation energy delivery are made when the patient moves during sleep. In some embodiments, a first portion of the EDM250 generates image data IDs (e.g., also optionally delivers stimulation energy), and a second portion of the EDM250 delivers stimulation energy (e.g., also optionally collects image data IDs). In some embodiments, the first and second portions of the EDM250 deliver stimulation energy to at least the same target tissue (resulting in, for example, the total amount of stimulation energy delivered to the target tissue exceeding the maximum amount delivered by either portion of the EDM250).

[0066] System 10 may include an FAD300 which may include one, two or more force-applying devices which are implanted in, positioned, and / or provided to the patient to supply one or more forces (e.g., forces applied to the patient's target tissue relatively continuously and / or intermittently over periods of at least one week, at least one month, at least three months, and / or at least six months). System 10 may include a plurality of force supply devices such as FAD300, 300', and / or 300” (generally FAD300) as shown in the illustration. In medical applications, one or more force supply portions of FAD300 are positioned at one or more locations inside, on, and / or near the patient, in this specification at location L300, so that target tissue adjacent to location L300 can receive the force applied by FAD300. Using FAD300, force can be applied to patient tissue (e.g., muscle tissue) to produce a therapeutic effect on that tissue (e.g., to strengthen muscles, or to exercise muscle tissue continuously and / or intermittently). Alternatively or additionally, FAD300 can apply force to patient tissue, compressing and / or / Alternatively, it may be used to form a scaffold (e.g., to form a scaffold for an airway), and may increase the opening (e.g., cross-sectional area) of an airway (e.g., to push tissue out of a patient's airway to treat sleep apnea). In some embodiments, the FAD300 is configured to apply force to tissue in a passage (e.g., blood vessels, conduits, tissue tubes, and / or valves) to close the passage (e.g., to close a valve). The FAD300 may include one or more parts that attach to tissue (e.g., to bone or other tissue), as described with reference to Figures 6A-6B and / or Figure 7 of this specification. The FAD300 may include an arched structure (e.g., including two actuator parts), as described with reference to Figure 7 of this specification.

[0067] System 10 may include a console 500 as shown in the figure, which includes one or more separate components that operably interface with one or more other components of System 10 and can provide and / or receive energy and / or data (such as control signals). In some embodiments, the console 500 includes one or more components configured to be operably attached to the EDD 100, for example, via a conduit, cable 501 in the figure, and / or via a wireless connection. In some embodiments, the console 500 includes one or more components configured to wirelessly communicate with other components of System 10, transmitting and / or receiving data between the EDD 100 (during use by a clinician in a medical procedure), the CEDD 200 (e.g., when implanted or placed in a patient), and / or the FAD 300 (e.g., when implanted or placed in a patient). Console 500 may include a controller 510, which may include one or more central processing units (CPUs), microprocessors, and / or other microcontrollers; memory storage components (such as volatile memory or non-volatile memory); signal processing and other electronic circuits, oscillator circuits such as voltage-controlled oscillator (VCO) circuits; analog-to-digital circuits; digital-to-analog circuits; and / or other components configured to control or interface with one or more components of System 10, such as EDD 100. Controller 510 may include a power supply and / or energy storage components (such as batteries and / or accumulators). Controller 510 may include one or more electronic elements, electronic assemblies, and / or other electronic components, for example, components selected from a group consisting of memory storage components, analog-to-digital converters, rectifier circuits, state machines, microprocessors, microcontrollers, filters and other signal modifiers, sensor interface circuits, transducer interface circuits, and combinations thereof.In some embodiments, the controller 510 includes a memory storage component (for example, coupled to the controller 510), which includes instructions, for example, instructions used by the controller 510 to generate an energy delivery waveform and / or to execute an algorithm, as described herein.

[0068] In some embodiments, the console 500 includes one, two, or more energy delivery assemblies, for example, the controller 510 includes one or more energy delivery assemblies. In these embodiments, the controller 510 may include assemblies configured to deliver one or more forms of energy, for example, selected from a group consisting of ultrasonic energy, radio frequency and / or other electromagnetic energy, optical energy (e.g., laser light energy), mechanical energy, chemical energy, thermal energy (such as thermal energy and / or cryogenic energy), and combinations thereof. In some embodiments, the console 500 includes a light source (such as a functional element 599 including a laser or other light source). The light source may be configured to supply light to the EDD100, CEDD200, FAD300, and / or other components of the system 10. The light source may be configured to perform imaging procedures (such as OCT or other light-based imaging procedures) and / or tissue elastography analysis. In some embodiments, the functional element 599 includes a light source, which is configured to deliver light to tissue and / or to an agonist, thereby affecting the tissue and / or the agonist (e.g., stimulating the tissue and / or activating the agonist, respectively). In some embodiments, the controller 510 includes one or more algorithms, such as algorithm 50 described below. In these embodiments, energy delivery and / or other functions supplied by the controller 510 and / or other components of the console 500 may be controlled by the algorithms.

[0069] System 10 may include the illustrated algorithm 50, which may include one or more algorithms. All or part of algorithm 50 may be integrated into one, two or more of the various components of System 10, such as EDD100, CEDD200, FAD300, and / or console 500. Algorithm 50 may include one or more machine learning, neural network, and / or other artificial intelligence algorithms (hereinafter referred to as "AI algorithms").

[0070] The algorithm 50 may be configured to determine and / or modify one or more energy delivery parameters as defined herein, for example, to effectively treat (e.g., excise) target tissue and avoid damage to non-target tissue.

[0071] In some embodiments, algorithm 50 (e.g., an AI algorithm) may be configured to determine the volume of target tissue to be treated and to effectively deliver a therapeutic effect to the patient while avoiding or at least minimizing damage to non-target tissue. In these embodiments, algorithm 50 may be further configured to determine and / or modify one or more energy delivery parameters (e.g., based on at least the determined volume) to effectively treat the determined target tissue volume while avoiding damage to non-target tissue, as described above.

[0072] In some embodiments, algorithm 50 is configured to perform a “tissue classification analysis,” which includes a tissue excision analysis (described below), a tissue type analysis (e.g., to distinguish between fat, nerve, muscle, and other tissue types), and / or another form of tissue classification analysis. In these embodiments, the tissue classification analysis performed by algorithm 50 may be based on tissue elastography data, such as tissue elastography data collected by system 10, as described herein.

[0073] Algorithm 50 may be configured to perform a tissue classification analysis, including a “tissue ablation analysis,” which involves the use of one or more types of information analyzed by Algorithm 50, to assess the level of ablation of the target tissue (e.g., the current ablation level) (e.g., ultrasound or MRI-based elastography analysis that distinguishes between living tissue and dead tissue, and / or excised and unexcised tissue). The results of this analysis may be used by System 10 to deliver energy in a closed-loop mode, as described herein. The tissue ablation data generated by the tissue ablation analysis may be stored as image data IDs (e.g., associated with one or more tissue locations). In some embodiments, System 10 delivers and / or receives energy (e.g., ultrasound energy) to the tissue, and Algorithm 50 performs a tissue ablation analysis based on the delivered and / or received energy. The tissue ablation analysis may be configured to determine the size (e.g., the geometric shape of the tissue volume) of the excised tissue (e.g., sufficiently excised to provide the intended benefit to the patient).

[0074] Algorithm 50 may be configured to perform a “tissue temperature analysis” which involves using one or more types of information analyzed by algorithm 50 to assess the temperature of the tissue (e.g., current temperature). The results of this analysis may be used by system 10 to deliver energy in a closed-loop mode, as described herein. The tissue temperature data generated by the tissue temperature analysis may be stored as image data IDs (e.g., associated with one or more tissue locations). In some embodiments, system 10 delivers and / or receives energy (e.g., ultrasonic energy) to the tissue, and algorithm 50 performs a tissue temperature analysis based on the delivered and / or received energy. In some embodiments, system 10 includes an infrared camera assembly. For example, functional elements 199, 299, 399, 599, and / or 999 may include an infrared camera assembly configured to measure the temperature of tissue (e.g., tissue to be excised), for example, when system 10 is configured to perform closed-loop energy delivery based on the measured tissue temperature.

[0075] Algorithm 50 may be configured to adjust energy delivery parameters based on sensor signals, for example, by using sleep sensor signals to modify energy delivery to a sleep apnea patient during sleep (to optimize the treatment provided to that sleep apnea patient). Energy delivery adjustments may be made during the delivery of ablation energy and / or stimulation energy.

[0076] In some embodiments, algorithm 50 is configured to verify that signals generated by sensors in system 10 are associated with the patient being treated by system 10, as described herein. For example, algorithm 50 may be configured to identify, distinguish, and / or verify that snoring or other sounds recorded by system 10 are associated with the patient and not with another person or other sound source (e.g., a television, a pet, or someone else in the same room as the patient while the patient is sleeping).

[0077] In some embodiments, the algorithm 50 is configured to receive signals from one or more sensors of the system 10 and identify whether the patient is breathing through their mouth or nose, allowing the system 10 to adjust energy delivery accordingly.

[0078] In some embodiments, the system 10 uses ultrasound (as described herein, for example) to collect image data IDs, such as B-mode acquired ultrasound image data IDs, and the algorithm 50 may include an AI algorithm (e.g., a machine learning algorithm) configured to evaluate the image data IDs to determine the level of tissue ablation (e.g., whether a sufficient volume of target tissue has been excised).

[0079] In some embodiments, System 10 collects image data IDs (e.g., using ultrasound as described herein), and Algorithm 50 analyzes the collected image data IDs to create a treatment plan (e.g., as described herein), the treatment plan including one or more treatment plans provided to the clinician as suggestions for the treatment of the patient from whom the image data IDs were collected. In these embodiments, Algorithm 50 may create the treatment plan based on further data, e.g., data relating to any physiological, genetic, and / or other patient information.

[0080] Each of the EDD100, CEDD200, and / or FAD300 (individually or collectively referred to herein as "Apparatus 100 / 200 / 300") may include, as illustrated, control modules, controllers 110, 210, and / or 310, respectively. Each of the controllers 110, 210, and / or 310 (individually or collectively referred to as controllers 110 / 210 / 310) may include one or more central processing units (CPUs), microprocessors, and / or other microcontrollers, memory (such as volatile memory or non-volatile memory), signal processing and other electronic circuits, analog-to-digital circuits, digital-to-analog circuits, and / or other components configured to control or interface with one or more components of System 10, such as EDD100, CEDD200, and / or FAD300, respectively. The controller 110 / 210 / 310 may include one or more electronic elements, electronic assemblies, and / or other electronic components, selected from a group consisting of, for example, memory storage components, analog-to-digital converters, rectifier circuits, state machines, microprocessors, microcontrollers, filters and other signal modifiers, sensor interface circuits, transducer interface circuits, and combinations thereof. In some embodiments, the controller 110 / 210 / 310 includes a memory storage component, which includes instructions, for example, instructions used by the controller 110 / 210 / 310 to execute algorithms, as described herein. The controller 110 / 210 / 310 may include a power source, such as an energy storage component (e.g., a rechargeable battery and / or a stoichiometer). In some embodiments, at least a portion of the controller 110 / 210 / 310 is implanted in the patient to adjust and / or control the energy delivered by the implanted portion of the associated EDM 150 / 250 / 350 (e.g., automatically adjusted via algorithm 50) (without requiring control signals sent by external components of system 10).Alternatively or additionally, the controller 110 / 210 / 310 may include at least one portion located outside the patient's body to wirelessly transmit control signals to the implanted portion of the EDD 100 / 200 / 300. In some embodiments, energy is wirelessly transmitted to a battery, accumulator, and / or other energy storage element in the implanted portion of the controller 110 / 210 / 310, for example, via the transmission of electrical energy (e.g., via inductive coupling and / or high-frequency signals) and / or via the transmission of ultrasonic energy (e.g., ultrasonic energy received by one or more ultrasonic transducers and converted into electrical energy, as described herein). In these embodiments, energy may be transmitted from another implanted portion of the controller 110 / 210 / 310 and / or from a portion located outside the controller 110 / 210 / 310. In these embodiments, the energy delivered to treat tissue (e.g., stimulate and / or excise tissue) may be delivered by the implantable portion of the EDM150 / 250 / 350 at a certain energy setting (e.g., frequency, amplitude, waveform shape, etc.), and this energy setting is independent of (e.g., different from) the energy setting for energy delivery to the energy storage element of the controller 110 / 210 / 310. For example, the energy delivery to the implant may be at a higher frequency than the energy delivery used to treat the tissue.

[0081] The controllers 110 / 210 / 310 may include one or more energy storage components, e.g., a battery, a capacitor, and / or other energy storage components. Each of these one or more energy storage components may be located in the external and / or implantable portions of the device 100 / 200 / 300. The energy storage components of the controllers 110 / 210 / 310 may be configured to be charged via wireless power transmission transmitted to the controllers 110 / 210 / 310, for example, via a charging assembly (e.g., a tool 950 described below that includes a charging assembly) configured to wirelessly charge energy storage components of another device. In some embodiments, the device 100 / 200 / 300 includes a charging assembly (e.g., a wireless charger integrated into the external portion of the device 100 / 200 / 300). In some embodiments, the wireless power transmission includes electromagnetic energy received and stored by the controllers 110 / 210 / 310 (e.g., received via patient tissue by portions of implantable controllers 210 and / or 310). Alternatively or additionally, wireless power transmission may include the transmission of sound energy (such as ultrasonic energy), light energy, and / or other non-electromagnetic energy, which is received by the controllers 110 / 210 / 310 (e.g., through patient tissue, by a portion of the implanted controllers 210 and / or 310), converted into electrical energy (e.g., by an array of one or more ultrasonic transducers and / or optical transducers in the CEDD200 and / or FAD300), and stored in the implanted energy storage components of the controllers 110 / 210 / 310. In some embodiments, the implanted energy storage components of the controllers 210 and / or 310 are periodically recharged before the period of use (e.g., delivery of treatment to tissue). In some embodiments, after recharging of the CEDD200 or FAD300, the EDM250 may deliver therapeutic energy (such as stimulating energy) to the tissue, or a force supply assembly, FAA360 in the illustration, may apply therapeutic force to the tissue.In these embodiments, recharging may occur before treatment delivery (for example, as described herein, treatment is delivered nightly to a sleep apnea patient after recharging has occurred).

[0082] Controllers 110 / 210 / 310 may be configured in automatic mode, for example, so that the energy and / or force delivered by devices 100, 200, and / or 300 is automatically adjusted (turned on, turned off, and / or its intensity and / or form is changed). For example, System 10 may be configured to treat a patient with sleep apnea, and the controllers 110 / 210 / 310 may be configured to automatically perform functions selected from the following groups, which include turning on energy delivery and / or force delivery when the patient falls asleep (e.g., determined by the sensors and / or algorithm 50 of System 10); turning off energy delivery and / or force delivery when the patient wakes up (e.g., determined by the sensors and / or algorithm 50 of System 10); changing energy delivery and / or force delivery (e.g., increasing and / or decreasing energy delivery and / or force delivery) when the occurrence of sleep apnea events changes (e.g., worsening and / or becoming more frequent, as determined by the sensors and / or algorithm 50 of System 10); and combinations thereof. In some embodiments, System 10 is configured in manual mode (e.g., with or without automatic mode), and the patient can easily turn on, off, and / or change the energy delivery and / or force delivery of System 10 (hereinafter, individually or collectively, “energy delivery” or “force delivery”), for example, via voice control and / or a simple tap of a switch (e.g., via the user interface of System 10 as described herein). In some embodiments, if the patient manually turns off the energy and / or force delivery (e.g., when the patient wakes up), and then System 10 determines that the patient has fallen asleep again (e.g., fallen asleep again), System 10 may automatically restart the energy and / or force delivery (e.g., to prevent the occurrence of a sleep apnea event).

[0083] Each console 500 may include a user interface 590 as shown in the figure. The user interface 590 may include various controls configured to receive input from the operator of system 10 (such as a clinician of system 10 or another user), and may also include various output devices configured to provide information to the operator. The user interface 590 may include one or more user input components selected from a group consisting of buttons, switches, foot pedals, levers, keyboards, mice, touchscreens, microphones, and combinations thereof. The user interface 590 may include one or more user output components selected from a group consisting of displays, touchscreens, lights, speakers, haptic transducers, and combinations thereof.

[0084] Similarly, EDD100, CEDD200, and / or FAD300 may each include a user interface, user interfaces 190, 290, and / or 390, respectively, as shown in the figure, each of which may include similar user input and / or user output components, as described above with reference to user interface 590. In some embodiments, at least a portion of the user interface 590 of console 500 is integrated into one or more of user interfaces 190, 290, and / or 390. In some embodiments, user interfaces 290 and / or 390 are configured to be used by an implant clinician before the associated devices 200 and / or 300 are implanted in a patient (for example, the user interface components include sealed components and / or are otherwise configured to be implanted in a patient after initial use). User interfaces 190, 290, and / or 390 (referred to herein individually or collectively as "User Interfaces 190 / 290 / 390") may include one or more switches or other controls that enable a patient or other operator of System 10 to turn on, turn off, and / or adjust the delivery of force and / or energy delivered by the devices 100 / 200 / 300 of System 10. In some embodiments, User Interfaces 190 / 290 / 390, and / or 590 include user interfaces that adapt (e.g., dynamically adapt) based on information collected by System 10 (e.g., image data IDs and / or other patient information collected by System 10). For example, energy delivery options and / or other therapeutic parameters provided by the user interface may be modified (e.g., limited and / or expanded from a standard set of settings) based on data collected during medical procedures performed using the system 10 (e.g., energy delivery data, tissue ablation and / or other tissue characteristic data, and / or other data collected by one or more sensors of the system 10, as described herein).

[0085] System 10 may include one or more functional elements, for example, functional element 199 of EDD100, functional element 299 of CEDD200, functional element 399 of FAD300, functional element 599 of console 500, and / or functional element 999, as shown respectively. Functional elements 199, 299, 399, 599, and / or 999 may each include one or more sensors and / or one or more transducers, as described herein. Functional elements 199, 299, 399, 599, and / or 999 may include wireless elements, for example, wireless sensors capable of receiving power wirelessly and / or transmitting signals wirelessly.

[0086] In some embodiments, functional elements 199, 299, 399, 599, and / or 999 include one or more sensors selected from a group consisting of accelerometers, gravity-based sensors, strain gauges, acoustic sensors (e.g., microphones or other acoustic sensors), electromagnetic sensors (e.g., Hall effect sensors), pressure sensors, vibration sensors, temperature sensors, vacuum sensors, GPS sensors, humidity sensors, flow sensors (e.g., airflow sensors), and combinations thereof.

[0087] In some embodiments, functional elements 199, 299, 399, 599, and / or 999 may include one, two, or more sensors configured to measure “patient parameters” (e.g., patient sleep parameters or other patient physiological parameters, and / or patient environmental parameters, as defined below, respectively).

[0088] Functional elements 199, 299, 399, 599, and / or 999 may include a patient's "physiological sensor" comprising one, two, or more sensors configured to measure the patient's "physiological parameters," which are sleep parameters (e.g., defined below), heart rate, blood pressure, respiratory rate, sweating, blood gas levels, blood glucose levels, brain and / or other neural activity measured by, for example, electroencephalography (EEG), local electric field potential (LFP), and / or neuronal firing (e.g., single neuron firing activity), eye movements, positive end-expiratory pressure (PEEP) sensors, bone-placed sensors (e.g., sensors placed in the jaw, configured to measure snoring and / or other dyspnea, sleep levels such as REM sleep levels, presence of apnea events, and / or other sleep parameters), and combinations thereof.

[0089] Functional elements 199, 299, 399, 599, and / or 999 may include a “sleep sensor” having one, two, or more sensors configured to measure one or more “sleep parameters” of a patient, for example, the parameters being selected from a group consisting of snoring parameters (e.g., snoring amplitude, snoring frequency, snoring waveform shape, snoring type, and / or other snoring parameters), occurrence of sleep apnea events, sleep states (stage 1, stage 2, stage 3, REM sleep, etc.), respiratory parameters (breathing type such as nasal breathing and / or mouth breathing, respiratory rate, and / or other respiratory parameters, etc.), patient’s sleeping position (left-facing, right-facing, supine, and / or prone, etc.), heart rate and / or cardiac variability, and combinations thereof. In some embodiments, the sleep parameters include one, two, or more parameters that may be recorded (e.g., measured by one, two, or more sensors) and / or provided by the patient's wearable devices, such as a smartwatch, an activity recorder (such as one worn on the patient's wrist), and / or other portable devices.

[0090] Functional elements 199, 299, 399, 599, and / or 999 may include a patient “environmental sensor” comprising one, two, or more sensors configured to measure the patient’s “environmental parameters,” such as room temperature, room pressure, room brightness level, ambient noise level, room volume, and combinations thereof.

[0091] In some embodiments, functional elements 199, 299, 399, 599, and / or 999 include one or more sensors configured to measure parameters of system 10, for example, system parameters selected from a group consisting of temperature (such as the temperature of a portion of the components of system 10), velocity and / or acceleration, position, strain, energy delivery level, force delivery level, and combinations thereof. In some embodiments, functional elements 199, 299, 399, 599, and / or 999 include one or more sensors configured to measure system parameters from multiple procedures performed using system 10 (such as multiple procedures performed on one patient and / or multiple patients). In these embodiments, algorithm 50 may be configured to analyze recorded parameters (such as recorded levels of recorded parameters) and adjust system 10 based on the analysis of multiple procedure data (e.g., adjust one or more settings of system 10).

[0092] In some embodiments, functional elements 199, 299, 399, 599, and / or 999 include one or more transducers selected from a group consisting of cooling elements such as Peltier elements, heating elements such as Peltier elements or heat pumps, vibration transducers, light-emitting elements (such as diodes, lasers, and / or other light-emitting elements), light-receiving elements (such as photodetectors, lenses, filters, beam splitters, and / or other light-receiving elements), magnetic field generating elements, vacuum generating elements, mechanical manipulators (such as tissue manipulators and / or component manipulators of system 10), solenoids or other rotary or linear actuators, motors, drug or other pharmacokinetic delivery assemblies, and combinations thereof.

[0093] In some embodiments, functional elements 199, 299, 399, 599, and / or 999 include assemblies or other components configured to supply vacuum to other components of system 10. For example, functional elements 199, 299, and / or 399 may include tissue engagement ports configured to receive vacuum (e.g., from controllers 110, 210, and / or 310, and / or console 500) to stabilize tissue, capture tissue (e.g., pull tissue toward the port), and / or engage tissue in other ways, at which point vacuum is applied to the ports. Functional elements 199, 299, 399, 599, and / or 999 may include vacuum sources, such as vacuum, that can be applied to such tissue engagement ports. In some embodiments, functional elements 199, 299, 399, 599, and / or 999 include components configured to supply vacuum to manipulate tissue, for example, to move tissue relative to the EDM 150 / 250 / 350, and to modify energy and / or force delivery to the tissue based on the tissue manipulation. Alternatively or additionally, the supplied vacuum may be configured to position (for example, and maintain the position of the tissue) the tissue relative to the EDM 150 / 250 / 350.

[0094] In some embodiments, functional elements 199, 299, 399, 599, and / or 999 include a mechanical operation assembly configured to operate one or more components of the system 10 (such as robotic operation), for example, to operate the position, configuration, and / or orientation of the EDM 150 / 250 / 350 relative to the patient. For example, a functional element may include a frame positioned in close proximity to patient tissue and an XY manipulator that moves the EDM 150 / 250 / 350 relative to the patient tissue in at least two dimensions, for example, to deliver energy from multiple positions based on positioning performed by the manipulator within the frame.

[0095] In some embodiments, functional elements 199, 299, 399, 599, and / or 999 include adhesives and / or adhesive dispensing components, for example, in which the adhesive is used to temporarily (e.g., less than one day) and / or chronically (e.g., at least one week, one month, or three months) attach components of system 10 (e.g., a portion of device 100 / 200 / 300) to the patient's tissue and / or another component of system 10.

[0096] In some embodiments, functional elements 199, 299, 399, 599, and / or 999 include a cooling fluid or a cooling component (e.g., a thermoelectric cooling element) and / or an assembly configured to cool (e.g., to cool components of system 10). In some embodiments, system 10 is configured to cool tissue and / or components of system 10 during the delivery of energy (e.g., excision energy) to avoid, for example, damage to non-target tissue and / or degradation of components of system 10. For example, system 10 may include a functional element that includes a cooling element disposed within spacers 151 and / or 251 as described herein. Alternatively or additionally, system 10 may include a functional element having an assembly configured to supply a cooling fluid to spacers 151 and / or 251 (e.g., in a recirculation arrangement). In some embodiments, a cooling element is provided and disposed on the tissue surface to allow ablation of target tissue, including subsurface tissue, while avoiding damage to surface tissue adjacent to the subsurface tissue to be excised.

[0097] In some embodiments, functional elements 199, 299, 399, 599, and / or 999 include assemblies or other components configured to apply force to tissue (e.g., gripping components configured to apply tension to tissue, and / or pressing elements configured to supply compressive force to tissue), for example, supplying force (tension and / or compressive force, etc.) to tissue (such as target tissue) while energy is being delivered to the target tissue by another component of system 10.

[0098] In some embodiments, functional elements 199, 299, 399, 599, and / or 999 include position sensors (such as accelerometers) configured to track the positions of components of system 10 (such as EDM 150 / 250 / 350) and / or the patient (such as the patient's target tissue). In these embodiments, the positional information of the patient and / or system 10 is used to deliver energy and / or force in a closed-loop configuration, and the delivery can be modified based on the movement of the patient and / or components of system 10 (for example, correcting the direction of delivery and / or adjusting the delivery to compensate for the movement via algorithm 50, etc.).

[0099] In some embodiments, functional elements 199, 299, 399, 599, and / or 999 include one or more fluid delivery elements (such as one or more needles) configured to deliver a substance (such as a fluid and / or other fluid material) to a location close to the target tissue, for example, during energy delivery to the target tissue (for cooling and / or heating the tissue, etc.). In some embodiments, the substance to be delivered includes an activator 920 described herein (such as a drug or other activator delivered to a patient).

[0100] In some embodiments, the functional element 299 includes a sensor that is placed on the patient's skin and / or implanted in the patient's body and configured to measure, for example, the patient's sleep parameters. In some embodiments, the functional element 299 includes a vibration sensor, an accelerometer, and / or another sensor placed on or near the patient's chin to measure, for example, the patient's snoring level or other sleep parameters.

[0101] In some embodiments, the functional element 999 includes mobile phones, tablets, computers (such as laptop computers), alarm clocks, bed shakers, alarm devices, and combinations thereof. The functional element 999 may include mobile phones, laptops, tablets, cameras, and / or patient maintenance devices, each including one, two, or more sensors, for example, sensors configured to measure the patient's physiological parameters (such as sleep parameters) and / or patient environmental parameters, as described herein. In some embodiments, the functional element 999 includes one, two, or more of these sensors (such as patient physiological sensors and / or patient environmental sensors) located within the imaging device 910, the treatment device 930, the consumption device 940, and / or the tool 950, as described herein.

[0102] System 10 may include an accessory 900 shown in the illustration, which may include one or more accessories used to treat and / or diagnose a patient. In some embodiments, the accessory 900 includes one or more imaging devices, imaging device 910 shown in the illustration. Imaging device 910 may include one, two or more imaging devices selected from the group consisting of magnetic resonance imaging (MRI), CT scanners, ultrasound imaging devices, OCT and / or other laser-based imaging devices, fluoroscopy imaging devices or other X-ray-based imaging devices, and combinations thereof. In some embodiments, imaging device 910 provides image data IDs to System 10, and as a result, one or more of the devices 100 / 200 / 300 may be guided via the provided image data IDs. For example, the imaging device 910 may include an MRI or ultrasound imaging device that provides image data IDs, which are configured to direct (e.g., automatically and / or manually) energy delivery to tissue by the EDM 150 and / or EDM 250 (such as focused ultrasound and / or other energy delivery) and / or force delivery to tissue by the FAA 360 (e.g., automatically and / or manually). In some embodiments, the imaging device 910 includes an ultrasound imaging device that provides positive end-expiratory pressure (PEEP) measurement to quantify and / or monitor the therapeutic effect provided by the system 10 described herein. In some embodiments, the device 100 / 200 / 300 is constructed and configured to include the imaging device 910 (for example, the device 100 / 200 / 300 includes an array of ultrasound elements and / or optical elements, which are configured to generate image data IDs via the transmission and / or reception of ultrasound energy and / or optical energy, respectively, as described herein).

[0103] In some embodiments, the accessory device 900 includes one or more activators, activator 920 in the illustration. The activator 920 may include one, two or more activators selected from the group consisting of pharmaceuticals, coolants, warming agents, lubricants, conductive agents such as acoustic, electrical, and / or thermally conductive gels, magnetic agents, visible agents such as radioluminescent agents, magnetic reflectors, and / or ultrasonic reflectors, and combinations thereof.

[0104] In some embodiments, the accessory device 900 includes one or more therapeutic devices, such as the illustrated therapeutic device 930. In some embodiments, the therapeutic device 930 includes an implant that is inserted into the patient's soft palate or other airway tissue and configured to harden and / or reduce vibration of the tissue and / or cause deflection, compression and / or repositioning of the tissue outside the airway (such as to reduce the likelihood of sleep apnea events). In some embodiments, the therapeutic device 930 includes a stent, for example, a temporary or permanent stent that is placed in a segment of the nasal cavity and / or other airway segment of the patient and affects the shape of the segment (such as after treatment of the system 10 is performed on or near the segment, as described above). In some embodiments, the therapeutic device 930 includes an extension device, such as a jaw extension device. In some embodiments, the treatment device 930 includes surgical tools, which are selected from a group consisting of scalpels, electrosurgical incisions and / or hemostatic devices (also known as “Bobbies”), retractors, clamps, fastening devices such as sutures, staples, adhesives, etc., and combinations thereof. In some embodiments, algorithm 50 is configured to control the treatment device 930 automatically or semi-automatically (“automatically” as herein). For example, energy delivery and / or other treatments supplied by the treatment device 930 may be supplied via algorithm 50 in a closed-loop configuration. In some embodiments, algorithm 50 controls the operation of the treatment device 930 based on an analysis of image data IDs (such as ultrasound-based image data IDs as described herein) collected by system 10. The image data IDs used by algorithm 50 to control the treatment device 930 may be collected immediately after being collected by system 10, for example, the image data IDs may be collected within 5 minutes, 3 minutes, and / or 1 minute of control of the treatment device 930 by algorithm 50 (for example, at least a portion of them may be collected).

[0105] In some embodiments, the accessory device 900 includes one or more customized or standard consumer electronic devices, such as the illustrated consumer device 940. In some embodiments, the consumer device 940 includes one, two or more devices selected from a group consisting of a mobile phone (such as a cell phone), a watch (such as a smartwatch), a camera, an alarm clock, a computer such as a laptop computer or tablet, a bed such as an electrically adjustable bed, a nightstand device such as a clock and / or lamp, and combinations thereof.

[0106] In some embodiments, the accessory device 900 includes one or more tools, tool 950 in the illustration. Tool 950 may include one, two or more components selected from a group consisting of a bed such as an electrically adjustable bed, a bed shaker, an alarm clock or other bedside device (e.g., configured to wirelessly communicate with device 100 / 200 / 300), and combinations thereof. In some embodiments, tool 950 includes a tool that adjusts the patient's position (e.g., an adjustable bed or other tool) to reduce the patient's snoring and / or the likelihood of apnea events, for example, the adjustment is initiated and / or controlled in any other way via a signal provided by algorithm 50 (e.g., algorithm 50 configured to detect and / or predict snoring and / or apnea events). In some embodiments, tool 950 includes a charging device, such as a wireless charging device configured to deliver electromagnetic energy, ultrasonic energy, light energy, and / or other energy to a separate device to charge that device. In these embodiments, the device 100 / 200 / 300 may include a tool 950 (for example, a charging device is integrated into the device 100 / 200 / 300). In some embodiments, the tool 950 may include an assembly configured to stabilize one or more components of the system 10 to maintain the position of the EDM 150 of the EDD 100 relative to the patient's tissue (for example, to allow some patient movement during energy delivery while preventing undesirable energy delivery to non-target tissue). In these embodiments, the tool 950 may include a tool that can be attached to the patient's jaw, and / or a tool that can maintain the patient's jaw in a specific position, and / or prevent movement of the patient's jaw. The tool 950 may include a face mask assembly, a retainer, or both. In some embodiments, the tool 950 is customized for a specific patient, for example, the tool 950 is manufactured and / or otherwise constructed based on a photograph of the patient and / or a medical image of the patient's tissue (such as an ultrasound image, X-ray, or other medical image, e.g., a 2D or 3D image generated by a scanning device).Tool 950 may include an operating tool which may be configured to operate the EDM150 / 250 / 350 on patient tissue as described herein. In some embodiments, Tool 950 is configured to position the EDM150 / 250 / 350 on target tissue (such as target tissue of the tongue) in one, two, or three dimensions.

[0107] The accessory device 900 may include a functional element 999 as described above and separately herein. In some embodiments, the consumer device 940 includes a functional element 999, for example, if the consumer device 940 includes a bed or other device that is placed in close proximity to the patient during sleep, and the functional element 999 includes one or more sensors configured to measure patient parameters, such as the patient's sleep parameters.

[0108] System 10 may include a network 600, as shown, which may include one, two, or more wired and / or wireless computer networks, such as the Internet, a local area network, a cellular network, and / or other data sharing, storage, and / or transmission platforms. Network 600 may be configured to transfer data between two or more components of System 10 and / or between System 10 at a first location (such as a first hospital or other clinical facility) and System 10 at a second location (such as a second hospital or other clinical facility). Network 600 may include a network accessed by components of System 10 when System 10 is configured to transfer information in a cloud-based configuration. Patient information and / or System 10 usage information can be transferred and / or stored using Network 600, for example, when an algorithm 50 (such as an AI algorithm) is configured to analyze information from one patient and / or a group of patients to coordinate the use of System 10 for these or other patients (for example, through the creation of treatment plans, as described herein).

[0109] EDD100 and / or CEDD200 (referred to herein individually or collectively as “Apparatus 100 / 200”) may each include an Energy Delivery Module, EDM150 and / or EDM250, as shown in the illustration. In some embodiments, FAD300 includes an Energy Delivery Module, EDM350 as shown, and as a result, FAD300 can perform both applying force to tissue and delivering energy to tissue (e.g., delivering energy to image and / or excise tissue). EDM150, 250, and / or 350 (referred to herein individually or collectively as “EDM150 / 250 / 350”) may be configured to deliver one, two, or more forms of energy to be delivered to tissue in order to perform tissue diagnostic procedures and / or tissue therapeutic procedures, as described above and herein. The EDM150 / 250 / 350 may be configured to deliver and / or receive energy to and / or from tissue and generate tissue image data IDs, for example, when energy (such as ultrasonic energy and / or light energy) is delivered by at least a portion of the EDM150 / 250 / 350 and reflected energy (such as reflected ultrasonic energy and / or light energy, respectively) is received by similar and / or different portions of the EDM150 / 250 / 350, and as a result, image data may be created based on the transmitted and received energy. In some embodiments, the system 10 is configured to generate image data IDs that include tissue temperature information (e.g., one or more temperature readings for one or more volumes of tissue) and / or tissue ablation information (e.g., completion of ablation information for one or more volumes of tissue), as described herein. For example, algorithm 50 may be configured to determine tissue temperature information and / or tissue ablation information based on other image data IDs generated via energy delivered and / or received by EDM150 / 250 / 350, as also described herein.In some embodiments, EDM150, 250, and / or 350 include energy delivery and / or energy receiving components, each comprising an array of energy delivery elements 159, 259, and / or 359, for example, one or more piezoelectric elements and / or an array of one or more CMUTs configured to deliver and / or receive ultrasonic energy. In some embodiments, EDM150 / 250 / 350 is configured to be controlled via algorithm 50 (such as an AI or other algorithm configured to control EDM150 / 250 / 350 based on image data ID and / or other data collected by system 10) (in a closed-loop or other automated configuration, etc.). In some embodiments, EDM150 / 250 / 350 has a similar structure and arrangement to the applicant's concurrently pending international PCT patent application PCT / US2021 / 063743, titled “Tissue Interface System,” filed on 16 December 2021 [Reference No. USD-003-PCT].

[0110] EDD100 and / or CEDD200 may each include components configured to reflect energy, for example, mirrors 155 and / or 255, as shown in the figures. Each of the mirrors 155 and / or 255 (individually or collectively referred to herein as "mirrors 155 / 255") may include one or more mirrors, for example, one or more acoustic mirrors (such as mirrors configured to reflect ultrasonic energy and redirect the ultrasonic energy to target tissue). In some embodiments, mirrors 155 / 255 include mirrors configured to reflect light energy and / or other forms of energy. Mirrors 155 / 255 may be constructed, placed, and / or positioned at the location of tissue, so that the delivered energy is directed (or redirected) to target tissue. Mirrors 155 / 255 may be placed in the patient's body temporarily (e.g., less than one day) and / or long-term (e.g., at least one week, one month, or three months).

[0111] FAD300 may include a Force-Applying Assembly, FAA360, as shown in the figure. FAA360 may include one, two, three, or more controllable actuator parts (hereinafter referred to as “actuators”) that adjust their shape, for example, bending, curling, cantilevering, rotating, and / or otherwise, based on applied voltage and / or current, temperature changes, and / or other drive signals of FAD300. In some embodiments, FAA360 includes a first actuator that applies force to a first tissue location (such as a location containing a first type of tissue, such as muscle) and at least a second actuator that applies force to a second tissue location (such as a location containing the same type of tissue and / or a different type of tissue). FAA360 may include three or more actuators. In some embodiments, the FAA360 includes a plurality of independently deployable actuators (e.g., controlled by a controller 310) that are deployed in different ways to optimize treatment (e.g., different shapes and / or different forces applied to tissue) (e.g., the deployment of the actuators is tilted for the anatomical structure and / or other physiological parameters specific to that patient, or through an optimization procedure that is otherwise optimized).

[0112] The FAA360 may include a piezoelectric-based actuator that changes shape based on a drive signal (such as an applied voltage). The FAA360 may include a shape memory alloy and / or a shape memory polymer that causes a shape change in the FAA360 when its temperature changes (e.g., through heating by a supplied current and / or cooling by a thermoelectric cooler and / or other cooling element). The FAA360 may include an electromechanical assembly which includes a motor, gears, actuators, cams and / or other components that can be remotely controlled (e.g., via a controller 310) to transition between a non-deployed state and a deployed (power supply, etc.) state.

[0113] In some embodiments, the FAA360 includes one, two, or more bimorph actuators, for example, a piezoelectric bimorph actuator having a first layer that contracts and a second layer that expands when a voltage is applied to the actuator. Alternatively or additionally, the FAA360 may include one, two, or more unimorph actuators (for example, a piezoelectric actuator configured as a cantilever having one active layer and one inactive layer).

[0114] The FAD300 may supply drive signals, including alternating current (AC) and / or direct current (DC) drive signals, to the FAA360 via the controller 310. AC drive signals may be transmitted to the FAA360 (e.g., to the piezoelectric actuator as described above) to cause forward and backward movement, providing a function selected from a group consisting of, for example, supplying a changing force to tissue to tense, strengthen, and / or increase muscle tissue (e.g., the muscle tissue of the patient's airway) and applying force to the airway tissue to adapt to the patient's respiration (e.g., an AC signal synchronized with the patient's respiration). The amplitude of the AC drive signal may correlate with the deflection distance and / or force applied to the tissue by the FAD300. DC drive signals may be transmitted to the FAA360, for example, the DC signal may be applied continuously, intermittently, or both. Similarly, the magnitude of the DC signal (e.g., voltage level) may correlate with the deflection distance and / or force applied to the tissue by the FAD300. A DC signal can be supplied to generate the fixing force applied to the tissue, and / or adjustment of the fixing shape (such as the fixing distance of the action).

[0115] The FAA360 may be configured to supply adjustable force (e.g., by adjusting the magnitude of an AC or DC signal), and as a result, the force may be adjusted in a procedure configured to optimize patient treatment, for example, a force titration procedure performed when patient feedback (e.g., comfort feedback) is collected and / or one or more patient physiological parameters are monitored and analyzed (e.g., manually by a clinician and / or automatically by algorithm 50). The force applied by the FAA360 may be adjusted continuously and / or intermittently, such as in a closed-loop mode as described herein. In some embodiments, the forces applied by multiple actuators of the FAA360 are adjusted independently and / or as a set.

[0116] FAA360 (and / or other parts of FAD300) may include one or more parts positioned on and / or within tissue, for example, airway tissue, muscle tissue, and / or other tissues that form a scaffold and / or are reinforced (e.g., strengthened). FAA360 may be fixed to bone or other tissue at one, two, or more locations, etc. FAA360 may be fixed to bone or other tissue using screws, staples, sutures, and / or other fixation elements. In some embodiments, FAA360 and / or FAD300 include an arched structure (shown in Figure 7) that can be fixed to tissue by its shape without requiring separate fixation elements. In these embodiments, FAA360 and / or FAD300 may be inserted and removed multiple times (e.g., periodically).

[0117] The FAA360 may be driven by a relatively low-frequency AC drive signal and / or DC signal and may have a thickness of several millimeters. The FAD300 may be implanted and include a first portion 300a containing the FAA360, the implanted first portion 300a receiving power from a second portion 300b (e.g., a second implanted portion, or a portion placed on the patient's skin adjacent to the implanted first portion). The power delivered by portion 300b may include ultrasonic energy transmitted at a frequency of several MHz (e.g., the resonant frequency of an FAD300 several millimeters thick). The first implanted portion of the FAD300 may take the received ultrasonic energy (e.g., via one or more piezoelectric transducers and / or CMUTs), convert it into a DC signal (e.g., DC power for immediate use), and / or store it in a capacitor and / or other energy storage element. Due to the relatively large size of the FAA360, the FAA360 may be "directional" in terms of the frequency of power supply. In some embodiments, the second portion 300b includes an ultrasonic element, which is arranged as a focusing array (such as a large aperture) configured to deliver focused ultrasound to the receiving set of ultrasonic elements in the first portion 300a. The ultrasonic element in the second portion 300b may include a 2D array of ultrasonic elements that supply power to the first portion 300a.

[0118] In some embodiments, the FAA360 is constructed and arranged as described with reference to Figures 2, 6A-6B, and / or 7 of this specification.

[0119] In some embodiments, the EDD100 and / or CEDD200 include a power supply assembly having a structure and arrangement similar to the FAD300 assembly 360 described herein, although not shown.

[0120] For example, EDD100, CEDD200, and / or FAD300, and / or other components of system 10, may be configured to deliver energy in one, two, or more energy forms, for example, one, two, or more energy forms selected from a group consisting of acoustic energy such as high-density focused ultrasound (HIFU) energy, other focused ultrasound energy, plane wave ultrasound energy, and / or other ultrasound energy; optical energy such as laser light energy; electromagnetic energy such as radio frequency (RF) energy and / or microwave energy; thermal energy such as thermal energy and / or cryogenic energy; mechanical energy; chemical energy; and combinations thereof. In some embodiments, the console 500 delivers one or more of these forms of energy to components of the system 10 (for example, to the EDD 100 if the EDD 100 is operably mounted to the console 500). The EDM 150 / 250 / 350 may be configured to deliver energy (such as ultrasound and / or other acoustic energy, light energy, electrical energy, and / or other forms of energy) to perform tissue reduction procedures (e.g., tissue ablation, lithotripsy, and / or tissue fracturing) and / or tissue augmentation procedures (e.g., nerve or muscle stimulation) to a patient.

[0121] The EDM150 / 250 / 350 may each include one or more energy delivery elements 159, 259, and / or 359, which are used to collect image data by receiving, for example, reflected energy (such as energy reflection from energy delivered by the same or other elements). Elements 159, 259, and / or 359 (individually or collectively as elements 159 / 259 / 359) may include 1D or 2D arrays of elements (such as ultrasonic elements). Elements 159 / 259 / 359 may include horizontal and / or vertical arrangements of elements. Element 159 / 259 / 359 may include arrays of elements (such as ultrasonic elements) configured in arrangements selected from the following groups: multiple 1D arrays of elements, flat arrays of elements, curved arrays of elements, arrangements of elements in the form of a flexible wrap (as illustrated with reference to Figures 4 and / or 5 herein), arrays of elements positioned at the end of an elongated probe and having a diameter approximating the diameter of the probe (as illustrated with reference to Figure 15 herein), arrays of elements positioned at the end of an elongated probe and having a diameter greater than the diameter of the probe (as illustrated with reference to Figure 16 herein), arrays having a spoon shape or other convex and / or concave shape (as illustrated with reference to Figures 18A to 18B herein, for making sufficient contact with the surface of the patient's tongue to deliver energy, for example, to the subcutaneous tissue of the tongue), tubular arrays of elements (such as solid or hollow tubular structures), partial circumferential arrays of elements, and combinations thereof. In some embodiments, the EDM150 / 250 / 350 may include geometric shapes (such as geometric shapes containing elements 159 / 259 / 359) configured to hold and / or stabilize tissue that will receive energy from elements 159 / 259 / 359, for example, arrangements having cups (such as those described with reference to Figure 9 of this specification), cones (such as those described with reference to Figure 10 of this specification), and / or cylinders (such as full-circumferential or partial-circumferential cylinders, as described with reference to Figure 11 of this specification).Alternatively or additionally, the EDM150 / 250 / 350 may include one or more vacuum ports configured to stabilize tissue (e.g., functional elements 199, 299, and / or 399, each containing one or more vacuum ports) (as described with reference to Figures 9, 10, and / or 11 of this specification). In some embodiments, the device 100 / 200 / 300 may be configured to compress tissue receiving energy (such as energy intended for excision and / or stimulation), for example, when the device 100 is operated by an operator and / or a component of system 10 (such as a robotic manipulator) to compress the tissue before and / or during energy delivery to the tissue by the EDM150 / 250 / 350.

[0122] In some embodiments, the EDM150 / 250 / 350 and / or another part of the device 100 / 200 / 300 includes an adjustable geometric shape, for example, an adjustable diameter of the cups, cones, and / or cylinders of the array of elements 159 / 259 / 359 (as illustrated, for example, with reference to Figures 9, 10, and 11 below). In these embodiments, the operator can adjust the geometric shape to suit the characteristics of the tissue being treated (e.g., to adapt to the dimensional characteristics of the patient's tonsils, tongue, and / or other tissues being treated). In some embodiments, one or more parts of the device 100 / 200 / 300 include a geometric shape (such as an adjustable geometric shape) that can consequently apply forces (such as adjustable forces) to the target tissue, for example, tensile and / or compressive forces applied to the target tissue (such as the target tissue to be excised). In some embodiments, the system 10 includes a kit of multiple devices 100 / 200 / 300 and / or components EDM150 / 250 / 350 (such as mountable versions), which may have various geometric shapes (e.g., various dimensions of the tissue contact portions of these components, e.g., to apply a desired force and / or to adapt to the geometric shape of the tissue being treated). In these embodiments, a clinician may select components from the kit of components to optimize the treatment (e.g., to optimize tissue imaging and / or energy delivery in the treatment).

[0123] The EDM150 / 250 / 350 includes an array of ultrasound transducers that deliver ultrasound energy (e.g., via all or part of a set of ultrasound transducers) at a minimum frequency (e.g., frequencies above 10 MHz, frequencies between 10 MHz and 20 MHz, etc.) to create image data IDs (images of tissue and / or other objects on and / or within the patient), while delivering ultrasound energy (e.g., via the same or different sets of ultrasound transducers) at a maximum frequency (e.g., below 10 MHz, or frequencies below 5 MHz, etc.) to excise tissue. For example, the EDM150 / 250 / 350 may image tissue using ultrasound delivered at 10 MHz or higher and excise tissue via HIFU energy delivery at frequencies below 10 MHz, e.g., below 5 MHz.

[0124] The EDM150 / 250 / 350 may include an array of ultrasound transducers (such as CMUT transducers) that receive (e.g., and deliver) ultrasound energy in a "folded state" during the creation of image data IDs, and deliver energy at the excision level using ultrasound transducers in an "unfolded state" (e.g., all or some of the transducers used to create the image data IDs).

[0125] The EDM150 / 250 / 350 may each include one or more energy delivery elements 159, 259, and / or 359, which are used to collect image data by receiving, for example, reflected energy (such as energy reflection from energy delivered by the same or other elements). Elements 159, 259, and / or 359 (individually or collectively as elements 159 / 259 / 359) may include 1D or 2D arrays of elements (such as ultrasonic elements). Elements 159 / 259 / 359 may include arrays of elements (such as ultrasonic elements) consisting of arrangements selected from a group consisting of multiple 1D arrays of elements, flat arrays of elements, curved arrays of elements, and arrangements of elements in the form of flexible wraps (as described with reference to Figures 4 and / or 5 herein).

[0126] The EDM150 / 250 / 350 may include an array of one, two, or more ultrasound transducers that induce thermal ablation via the delivery of focused ultrasound (such as HIFU). The EDM150 / 250 / 350 may include an array of one, two, or more ultrasound transducers configured to perform lithotripsy and / or tissue lithotripsy. The EDM150 / 250 / 350 may include an array of one, two, or more ultrasound transducers that deliver ultrasound energy to heat tissue to a non-ablationary level, causing a temperature rise of less than 50°C, or causing a temperature rise of 43°C to 50°C for a limited duration (such as a duration of less than 2 minutes). With these non-ablationary ultrasound energy deliveries, the EDM / 150 / 250 / 350 may be configured to liquefy certain types of tissue (such as adipose tissue) while avoiding damage to other tissue types (such as muscle and / or nerve tissue). Alternatively or additionally, the EDM150 / 250 / 350 may be configured to deliver ultrasonic energy at a non-ablation level that provides a “thermal massage effect” to tissue, thereby tightening and / or increasing tissue such as muscle tissue.

[0127] The EDM150 / 250 / 350 may include an array of ultrasound transducers configured to deliver ultrasound energy at frequencies that can be adjusted (e.g., by a clinician and / or automatically by System 10). For example, the EDM150 / 250 / 350 may be configured to deliver ultrasound energy to a target tissue containing a tissue volume having a specific thickness (e.g., plane wave delivery of ultrasound energy) and to excise from the tissue surface near the ultrasound array to a maximum depth from the array, where the depth of ablation depends on the frequency of the delivered ultrasound energy (e.g., controlled depth ablation of tissue).

[0128] The EDM150 / 250 / 350 may include an array of ultrasound transducers (such as a 2D array of ultrasound transmitters) configured to deliver focused ultrasound energy to excise multiple tissue locations (e.g., simultaneously or sequentially), where the multiple tissue locations are located within a tissue volume having heterogeneous structure (e.g., different tissue properties such as tissue type, tissue echogenicity, tissue cooling, and / or other thermal properties). The multiple tissue locations to be excised may include multiple locations within the tongue, tonsils, and / or other airway locations. In these embodiments, the EDM150 / 250 / 350 may include an array of ultrasound transducers delivering HIFU and / or other focused ultrasound at frequencies between 5 and 10 MHz. Each of the multiple tissue locations may include a relatively small volume of tissue, e.g., a volume with a length and width of approximately 0.5 mm × 3.0 mm, or 1 mm × 6.0 mm. In some embodiments, multiple relatively small volumes of tissue are excised to avoid significant swelling that may occur if a larger volume of tissue were excised.

[0129] The EDM150 / 250 / 350 may include an array of ultrasonic transducers configured to deliver excision ultrasonic energy to excise tissue while avoiding scab formation, for example, as described herein, where ultrasonic energy is delivered to the subsurface tissue while avoiding adverse effects on the surface tissue.

[0130] The EDM150 / 250 / 350 and / or imaging device 910 may collect image data IDs that include data related to target tissue and / or non-target tissue (e.g., data that can be used to distinguish between target and non-target tissue, and / or to distinguish between tissue types such as muscle, fat, and nerve). Image data IDs that include these two forms of data can be used manually by the operator of system 10 and / or automatically by algorithm 50 to determine one or more energy delivery settings, e.g., energy delivery settings that cause ablation of target tissue without damaging non-target tissue, as described herein. In some embodiments, image data IDs may include data related to the level of ablation or other damage to the tissue, as described herein. In these embodiments, algorithm 50 may be configured to stop energy delivery when sufficient ablation of the target tissue is confirmed (e.g., to avoid damage to adjacent tissue) and / or when damage to non-target tissue (e.g., any damage) is detected. In some embodiments, the algorithm includes biases, such as a bias that tends to avoid damage to non-target tissue (e.g., a bias that suggests a portion of the target tissue may not be excised or treated), or a bias that tends to ensure that all target tissue is excised or otherwise treated (e.g., a bias that suggests a portion of the non-target tissue may be excised or damaged).

[0131] The EDM150 / 250 / 350 and / or imaging device 910 may collect image data IDs that include data related to the patient's blood conduits, such as arteries, veins, and / or cardiac chambers. Using image data IDs that include blood conduit data, the delivery of ablation energy to blood conduits (e.g., blood conduits and the blood within them are non-target tissues) can be avoided (e.g., manually by the operator and / or automatically via algorithm 50). Alternatively or additionally, using image data IDs that include blood conduit data, ablation of blood conduits can be induced (e.g., manually by the operator and / or automatically via algorithm 50) (e.g., causing subsequent tissue death supplied by that particular blood conduit). In some embodiments, the image data IDs may include data related to air or other gas pockets in the patient, for example, gas pockets (e.g., identified by algorithm 50 and / or the operator) that should be avoided in the delivery of energy (e.g., ultrasound energy) by the EDM150 / 250 / 350. For example, in some embodiments, the energy delivery trajectory from the EDM150 / 250 / 350 to the target tissue being excised needs to avoid gas pockets. Avoiding gas pockets using image data IDs can be done manually by the operator of system 10 and / or automatically by algorithm 50.

[0132] In some embodiments, the EDM150, 250, and / or 350 are configured to deliver ultrasonic energy to tissue, such as focused ultrasound (HIFU or other focused ultrasound) and / or unfocused ultrasonic energy delivery. In these embodiments, the EDM150 / 250 / 350 may include an array of energy delivery elements (such as element 159 for the EDM150, element 259 for the EDM250, and / or element 359 for the EDM350), which include one, two, or more piezoelectric transducers, one, two, or more CMUTs, and / or an array of at least one piezoelectric transducer and at least one CMUT (such as a 1D or 2D array). In some embodiments, the EDM150 / 250 / 350 includes an ultrasonic-based array that includes both one or more piezoelectric transducers and one or more CMUT transducers. In these embodiments, the piezoelectric transducer may perform one or more functions not performed by the CMUT transducer, or the CMUT transducer may perform one or more functions not performed by the piezoelectric transducer. Certain one or more other functions may be performed by both one or more piezoelectric transducers and one or more CMUT transducers. Algorithm 50 is configured to compare the results of functions performed by both the piezoelectric transducer and the CMUT transducer (such as imaging functions), distinguish the two results (and utilize one result from the other, etc.), and / or combine the results to generate a new set of results based on both piezoelectric data and CMUT data. In some embodiments, ultrasonic imaging is performed, in which the piezoelectric transducer emits ultrasound and the CMUT transducer receives reflections of the emitted waves (such as reflections from various surfaces of tissue or other objects). The ultrasonic energy delivered by the EDM150 / 250 / 350 may be configured to perform tissue reduction and / or tissue augmentation procedures as described herein.In some embodiments, the ultrasonic energy delivered by the EDM150 / 250 / 350 may be received by a separate component of the system 10 (such as an implanted portion or other portion of the EDM150 / 250 / 350), where the separate component converts the received ultrasonic energy into electrical energy, which is then delivered, for example, to stimulate and / or treat tissue (e.g., via a voltage applied by one or more electrodes, as described herein with reference to Figures 4-5).

[0133] The EDM150, 250, and / or 350 may be configured to deliver energy (such as ultrasonic energy) at a relatively low power density to stimulate tissue without adversely affecting it (e.g., stimulating tissue without causing cell death and adversely affecting the cells of the tissue). Alternatively or additionally, the EDM150 / 250 / 350 may be configured to deliver energy (such as ultrasonic energy) in an energy delivery setting that causes cell death, for example, through heating at a level and duration that causes cell death, or at a level that causes tissue destruction (such as controlled cavitation of tissue). For example, each of the devices 100, 200, and / or 300 described herein may be configured to allow the operator of System 10 (via the user interface of System 10, etc.) to switch between a device that delivers tissue augmentation therapy (such as stimulation) and a device that performs tissue reduction therapy (such as thermal ablation and / or tissue destruction). System 10 may be configured to allow adjustment between continuous and pulsed energy delivery (manual or automatic, for example), as well as adjustment of the energy delivery frequency (such as the frequency of the delivered ultrasonic energy).

[0134] The EDM150, 250, and / or 350 may be configured to deliver ultrasonic energy to tissue as described herein. The ultrasonic energy delivered by the EDM150 / 250 / 350 can stimulate tissue (such as nerve tissue) with an ultrasonic energy of 50 W / cm². 2This is the case when the power density is less than 100 W / cm². The ultrasonic energy is, for example, at least 100 W / cm². 2 When delivered at a power density, it can be delivered by the EDM150 / 250 / 350 in a HIFU configuration. In some embodiments, the EDM150 / 250 / 350 is configured to perform tissue ablative surgery on tissue when a pressure level of 50 MPa is delivered.

[0135] The EDM150, 250, and / or 350 include an assembly comprising one or more Peltier elements configured to heat and cool target tissue (for example, tissue on one side of the Peltier element is cooled and tissue on the opposite side of the Peltier element is heated), which can move, strengthen, and / or massage the tissue.

[0136] EDD100 and / or CEDD200 may each include spacer elements, which are spacer 151 and / or spacer 251, respectively. In some embodiments, FAD300 includes spacer elements, not shown, having a similar structure and arrangement to spacer 151 and / or 152 described herein. Spacer 151 and / or 251 (referred to herein individually or collectively as “spacer 151 / 251”) may each include elements configured to be positioned between EDM150 and / or EDM250 and the tissue surface when EDD100 and / or CEDD200 are delivering energy to the target tissue. Spacer 151 / 251 may include balloons, reservoirs, and / or other fluid-containing structures configured to expand and / or contract, respectively, when fluid is added and / or removed. In some embodiments, the spacers 151 / 251 contain water or other acoustically conductive material (e.g., having an impedance close to that of tissue) so that ultrasound delivered from the EDM 150 and / or EDM 250 (individually or collectively “EDM 150 / 250”) passes through the spacers 151 / 251 into the patient’s body in a predictable manner. In some embodiments, the spacers 151 / 251 have an adjustable thickness so that an operator can adjust the distance between the EDM 150 / 250 and the tissue surface (e.g., manually), and / or another component of the EDD 100, CEDD 200 and / or system 10 can adjust the distance between the EDM 150 / 250 and the tissue surface (e.g., automatically). System 10 may be configured to automatically adjust the thickness of the spacers 151 / 251 via an AI-based algorithm 50, etc. The spacers 151 / 251 may be temporarily or permanently mounted in the housing of the device 100 and / or 200. In some embodiments, the spacers 151 / 251 are configured to be removably attached (e.g., by adhesive) to the patient's skin (e.g., one side of the spacers 151 / 251) and / or to the housing of the device 100 and / or 200 (e.g., the opposite side of the spacers) (e.g., by adhesive).The spacers 151 / 251 include a visual grid on their surface and can guide the mounting of the housings of the device 100 and / or 200 at multiple positions. In some embodiments, the spacers 151 / 251 may be configured to provide a cooling function to extract heat from the EDM 150 / 250 and / or from patient tissue. In some embodiments, the spacers 151 / 251 include electrodes, for example, return electrodes used to enable the delivery of unipolar electrical energy by electrodes of the device 100 and / or 200 (such as electrode 2120 described below).

[0137] In some embodiments, one or more components of System 10 include at least a “reabsorbable” portion, in other words, a portion that is implanted in the patient and configured to safely decompose over time. In some embodiments, CEDD200, FAD300 (such as at least a portion of FAA360), and / or at least a portion of the treatment device 930 (such as a stent or other scaffold-type device) are reabsorbable. In some embodiments, one or more components of System 10 include a reabsorbable polymer and / or reabsorbable magnesium. In some embodiments, components of System 10 configured to apply force to tissue and / or stabilize another component of System 10 within the tissue include a reabsorbable material (e.g., the applied force and / or stabilization is temporary).

[0138] System 10 is configured to identify treated (e.g., excised) tissue so that adjacent tissue can be treated appropriately (e.g., sequentially, a certain volume of tissue) and / or undesirable treatment of already treated tissue can be avoided. In some embodiments, algorithm 50 analyzes image data IDs collected by system 10 and records treated (e.g., excised) tissue by identifying and recording one or more anatomical landmarks with respect to the energy-receiving tissue (and recording the information as image data IDs, etc.). Alternatively or additionally, algorithm 50 may identify treated tissue by analyzing image data IDs and identifying treatment features that can be seen in post-treatment (e.g., post-ablation) tissue. In some embodiments, algorithm 50 is configured to identify treated tissue or position markers of treated tissue by performing elastic analysis and / or other tissue characterization analysis, as will be described shortly thereafter. In some embodiments, System 10 is configured to “mark” tissue (e.g., permanently and / or temporarily) and supply one, two, or more markers (such as one or more markers placed within the treated tissue, on the periphery of the treated tissue, and / or in close proximity to the treated tissue) used to identify the tissue excised or otherwise treated by System 10. EDM150 / 250 / 350 may be configured to deliver energy (such as HIFU energy) at a specific level (such as a higher energy level than the rest of the treated tissue) that causes identifiable features in the treated tissue (e.g., energy delivery causes cavitation within the treated tissue, which can later be identified by System 10). In some embodiments, a clinician using the device 100 may create one or more markers in the patient’s tissue (such as near one or more tissue targets), and the clinician (such as manually) and / or algorithm 50 (such as in an automated or semi-automated manner) may use the markers to complete a tissue treatment procedure based on previously created markers.

[0139] In some embodiments, System 10 is configured to classify tissue (e.g., via algorithm 50) to, for example, distinguish treated tissue from untreated tissue and / or distinguish one type of tissue from another type of tissue. For example, System 10 may be configured to classify tissue by performing tissue elastography, for example, when EDM 150 / 250 / 350 (e.g., configured to deliver ultrasound energy) and / or imaging device 910 (e.g., MRI) deliver low-frequency vibrations configured to measure the elasticity (e.g., stiffness) of the tissue. In some embodiments, System 10 is configured to measure the elasticity of a portion of the tissue to determine the level of tissue ablation (e.g., ablation delivered by System 10) and / or whether the portion of the tissue requires treatment (e.g., to be treated according to its current elasticity level). Alternatively or additionally, System 10 may be configured to track energy delivery (e.g., correlated with image data IDs) to track treated and untreated tissue. Identifying and / or tracking treated and / or untreated tissues is crucial, for example, to avoid multiple undesirable treatments to a single tissue location and / or to prevent "missed" treatments to specific tissue locations, which would improve the overall effectiveness of the procedure. Identifying and / or tracking treated and / or untreated tissues may be particularly important when a therapeutic procedure involves treating a number of different tissue targets (at least 5, 10, 25, or 50, etc.) by individual excision energy delivery (e.g., to treat multiple targets within a patient's tongue or other airway tissue location). In some embodiments, treated and / or to be treated tissue targets include anatomical locations (such as multiple tongue and / or other airway locations treated in a discontinuous manner), where tracking treated and / or untreated tissues is desired to prevent multiple undesirable energy deliveries to the same tissue.As described herein, System 10 may be configured to create markers in tissue that can be used to track energy delivery, such as by delivering “marking energy,” which includes energy (such as ultrasound energy) delivered in a set of energy delivery settings different from those used simply to excise tissue (e.g., energy delivered at a higher level than standard excision energy to cause a detectable change in the marked tissue). In some embodiments, System 10 may be configured to deliver marking energy in a specific pattern to mark tissue (e.g., two, three or more lines of HIFU or other energy delivery), which is a pattern that can be detected via algorithm 50 using, for example, a pattern recognition algorithm. System 10 may be configured to deliver marking energy along various locations around the volume of tissue excised (and / or to be excised) by System 10 to create an identifiable “treatment boundary” (e.g., via algorithm 50). In some embodiments, algorithm 50 may be configured to identify specific tissue types and / or combinations of tissue types (either or both “tissue types” as described herein) and to identify these specific tissue types in image data IDs. Tissue type data ("Data TTD") may be used to plan treatment procedures (e.g., defined as reference points) where certain tissue types are to be avoided for treatment (e.g., used as treatment boundaries), and / or where certain tissue types are to be treated (e.g., receive resection energy). In some embodiments, tissue type data TTD may include nerve location data, bone location data, vascular wall location data, and / or blood location data, for example, including identified tissues to be preserved (e.g., characterized as non-target tissue and not resected).In some embodiments, System 10 (such as Algorithm 50) is configured to provide a treatment plan using two or more of the following (e.g., based on the analysis): tissue type data (TTD) information, marked tissue information (tissues marked by EDM 150 / 250 / 350 as described herein, e.g., tissues identifiable by image analysis, elastography, and / or other analysis performed by Algorithm 50), and / or information provided by the clinician (e.g., including clinician confirmation information). In some embodiments, Algorithm 50 includes an AI algorithm configured to perform elastographic analysis that distinguishes treated tissue from untreated tissue (e.g., further recording the results in image data ID and / or registration data RD). In these embodiments, the treatment plan (e.g., created by the clinician, System 10, or both) safely includes energy delivery to multiple targets in a discontinuous manner, thus avoiding adverse effects on non-target tissues (e.g., high temperatures that may occur due to sequential treatment of multiple tissue targets in close proximity to each other). In some embodiments, the algorithm 50 is configured to compensate for and / or undesirable movements of the patient and / or EDM150 / 250 / 350 relative to the patient (and to at least identify them, such as entering a warning mode).

[0140] System 10 may be configured to create a temperature map of the target tissue to be treated, for example, a temperature map included in the image data ID that includes both the location of the target tissue and the location of non-target tissue adjacent to the location of the target tissue. The temperature map created by System 10 may be created during energy delivery (e.g., in real time) and, for example, the temperature map may be used to adjust energy delivery by EDM 150 / 250 / 350 and / or to identify excised tissue zones (e.g., unexcised zones, as described herein). In some embodiments, the imaging device 910 includes an MRI, and System 10 is configured to create a temperature map based on MR temperature measurements (e.g., via algorithm 50).

[0141] In some embodiments, the system 10 is configured to deliver energy (such as excision energy, marking energy, and / or other energy) to a first set of one or more specific volumes of target tissue using a first set of energy delivery settings, and to deliver energy (such as excision energy, marking energy, and / or other energy) to a second set of one or more specific volumes of target tissue using a second set of energy delivery settings. The first and second sets of target tissue to be treated may include a plurality of distinct tissue targets, such as at least 5, 10, 25, and / or 50 tissue targets, and may include tissue types selected from the group consisting of tongue tissue or other airway locations (such as those excised in sleep apnea treatment procedures), hair follicle or other hair segment tissue (such as those excised in alopecia treatment procedures), tumor tissue (such as those excised in cancer or other tumor treatment procedures), prostate tissue (such as those excised in BPH treatment procedures), and / or brain tissue (such as those treated in epileptic lesions or other brain tissue treatment procedures). In these embodiments, there may be differences between the first and second energy delivery settings, for example, the differences are configured to compensate for differences in the target tissue (e.g., different volumes of the target tissue, types of tissue within the target tissue) and / or to avoid damage to certain non-target tissues adjacent to the target tissue (e.g., to avoid adverse effects on nerves, blood vessels, and other potentially non-target tissues). Differences between the first and second energy delivery settings may include one or more differences in the type of energy delivered (e.g., ultrasonic energy versus electromagnetic, optical, chemical, and / or other energy forms), the amplitude of energy delivery, the frequency of energy delivery, the waveform of energy delivery (e.g., waveform shape), the duty cycle of energy delivery, the adjustment of energy delivery, the control of energy delivery, the focusing of energy delivery, and combinations thereof. In some embodiments, system 10 delivers HIFU, focused ultrasound, and / or other ultrasonic energy to a first volume of tissue at a first frequency and to a second volume of tissue smaller than the first volume at a second frequency higher than the first frequency.By using higher frequencies, adverse effects on non-target tissues near the target tissue, such as nerves and / or blood vessels near the target tissue to be resected, can be selectively avoided.

[0142] In some embodiments, all or part of the EDD100 and / or another component of the system 10 are configured to be robotically operated by an algorithm 50, for example, the algorithm 50 may include an AI algorithm configured to cause micromovements of the EDM150 during tissue treatment and / or diagnostic procedures. In some embodiments, the algorithm 50 is configured to move the EDM150 based on an analysis of the anatomical location of non-target tissues (such as nerves) adjacent to one or more tissue targets to be treated (e.g., to prevent damage to non-target tissues). For example, during resection energy delivery, the algorithm 50 may be configured to fine-tune the position of the EDM150 to avoid undesirable tissue damage. In these embodiments, the identification of non-target tissues (such as being recorded in image data IDs) is performed by a clinician, automatically determined by the system 10 (e.g., via an AI-based algorithm 50), and / or identified through a combination of identification by the algorithm 50 and confirmation by the clinician. In some embodiments, the system 10 is configured to stop energy delivery when an undesirable condition is detected by the algorithm 50, for example, when the algorithm 50 determines that resection energy is being delivered to non-target tissue and / or that the non-target tissue is being adversely affected.

[0143] In some embodiments, the system 10 is configured to treat blood vessels with a diameter less than the maximum diameter (such as one or more blood vessels supplying blood to a target tissue) (e.g., blood vessels with a diameter greater than the maximum diameter are not treated), for example, the maximum diameter being 2 mm, 1 mm, and / or 0.5 mm. In some embodiments, the system 10 is configured to deliver energy (such as ultrasonic energy) to treat the blood vessels, where the frequency of the delivered energy is based on the diameter of the segment of the blood vessel to be treated, and / or the distance between the blood vessel segment and the EDM 150 (such as the distance between the blood vessel segment and the energy delivery element 159).

[0144] System 10 may be configured to treat one, two, or more conditions selected from a group consisting of various medical conditions of the patient, such as sleep apnea, the presence of tumors and / or cysts, ovarian conditions, cosmetic problems, epilepsy, cognitive impairment and / or other neurological disorders, pain, prostate problems (such as benign prostatic hyperplasia), heart diseases such as atrial fibrillation and / or other arrhythmias, medical conditions for which the removal of nerve tissue is therapeutically effective, and combinations thereof.

[0145] System 10 may be configured to allow one or more operators (such as clinicians, nurses, technicians, and / or other healthcare providers of the patient) to perform medical procedures on the patient. As described above, System 10 may include one, two, three, or more energy delivery devices used in medical procedures, e.g., EDD100, EDD100', and / or EDD100” (individually or collectively EDD100) as shown. Similarly, System 10 may include one, two, three, or more long-term energy delivery devices, e.g., CEDD200, CEDD200', and / or CEDD200” (individually or collectively CEDD200), one, two, three, or more The system may include the above-mentioned power supply devices, for example, FAD300, FAD300', and / or FAD300” (individually or collectively as FAD300), and / or one, two, or more treatment devices 930. In some embodiments, the system 10 includes a plurality of devices 100, 200, 300, and / or 930, which are used in a single clinical procedure to diagnose and / or treat a patient with an undesirable medical condition (such as a disease or disorder). In some embodiments, the system 10 is used in a patient The system includes multiple devices 100, 200, 300, and / or 930 used in two or more separate clinical procedures (e.g., performed on separate days) to treat the condition of the patient. For example, multiple devices 100, 200, 300, and / or 930 may be used in one, two, or more clinical procedures performed to treat sleep apnea. One or more clinical procedures may include tissue stimulation (e.g., performed by EDD100 and / or CEDD200), tissue excision (e.g., performed by EDD100) This may include one, two, or more tissue treatments selected from a group consisting of (performed by) tissue reduction (e.g., performed by EDD100), muscle strengthening (e.g., performed by EDD100, CEDD200, and / or FAD300), tissue scaffold formation (e.g., scaffold formation by one or more forces applied by FAD300 and / or treatment device 930), treatments provided by treatment device 930, and combinations thereof, each of which is described herein.

[0146] System 10 may be configured to treat target tissues at various anatomical locations in the patient, where the target tissues include one, two, or more tissue types selected from the group consisting of airway tissue, bone (such as facial bones), cartilage, tumor tissue, hair segment tissue (e.g., all or part of the hair shaft, hair root, hair follicle, hair bulb, and / or segments of blood vessels supplying blood to the hair bulb tissue), cardiac tissue, brain tissue, liver tissue, kidney tissue, pancreatic tissue, organ tissue, blood, and combinations thereof. In some embodiments, the target tissue includes one or more types of “airway tissues,” such as adenoid tissue (e.g., also called pharyngeal tonsil tissue or nasopharyngeal tonsil tissue), cartilaginous tissue adjacent to the airway, epiglottic tissue, facial bones adjacent to the airway, genioglossal muscle tissue, geniohyoid bone tissue (e.g., C1 branch of the geniohyoid muscle), glossopharynx tissue, sublingual tissue, lymphoid tissue adjacent to the airway, nasal septum tissue, palatine tissue, pharyngeal wall tissue (e.g., lateral pharyngeal wall tissue), soft palate tissue, stylopharynx tissue, tensor veli palatine muscle tissue, tongue tissue (e.g., adipocytes and other fats of the tongue and intrinsic or extrinsic muscles of the tongue), tonsil tissue (e.g., palatine tonsil and / or lingual tonsil tissue), turbinate tissue (e.g., inferior turbinate tissue), vagus nerve tissue, and one or more tissues selected from a group consisting of combinations thereof (e.g., muscle, fat, and / or nerve tissue).

[0147] EDD100 and / or CEDD200 may be configured to deliver energy in a closed-loop mode (i.e., a closed-loop mode of energy delivery and / or other closed-loop mode operation), for example, when one or more sensors of system 10 (such as sensor-based functional elements 199, 299, 399, 599, and / or 999) provide patient and / or system information used to adjust the energy delivered by the device 100 / 200. Energy delivery by EDM150 / 250 may be adjusted in a closed-loop mode based on parameters of system 10 and / or patient parameters (such as the patient's physiological parameters and / or patient environmental parameters described herein, respectively). Energy delivery by EDM150 / 250 may be adjusted based on image data IDs described herein, for example, to change the direction of energy delivery (e.g., for detected patient movement and / or undesirable EDM150 / 250 movement) and / or to change one or more energy delivery settings (e.g., for an ablation level or other treatment level determined by algorithm 50 using image data IDs). In some embodiments, an image data ID is used to determine when the treatment (such as ablation) is sufficient, for example, when algorithm 50 analyzes ultrasound-based image data to confirm that sufficient changes have occurred in tissue properties. In some embodiments, the image data ID includes blood flow data (e.g., acquired via Doppler ultrasound), and energy delivery for treatment is based on the level and / or changes in blood flow, including in the target tissue and / or non-target tissue.

[0148] The FAD300 may be configured to apply force in closed-loop mode (i.e., a closed-loop mode for applying force and / or other closed-loop mode operation), for example, when one or more sensors of system 10 (such as sensor-based functional elements 199, 299, 399, 599, and / or 999) provide patient and / or system information used to adjust the energy delivered by the FAD300. The force applied by the FAD300 may be adjusted in closed-loop mode based on parameters of system 10 and / or patient parameters (e.g., the patient's physiological parameters and / or patient-environmental parameters as described herein, respectively). The force applied by the FAD300 may be adjusted by force adjustment procedures as described herein. The force applied by the FAD300 may be adjusted intermittently and / or continuously. The force applied by the FAD300 may be adjusted based on time and / or the patient's physiological parameters (such as sleep parameters like snoring). The force applied by the FAD300 can be adjusted to compensate for the patient's respiration (determined, for example, via signals provided by the respiratory sensor of System 10). The force applied by the FAD300 is adjusted based on the image data ID described herein, and the force applied can be adjusted, for example, by detected patient movement and / or undesirable movement of the FAD300 (determined by algorithm 50 using the image data ID). In some embodiments, the image data ID is used to determine when the applied force has reached a sufficient level (such as a sufficient level of force and / or a sufficient duration for the force to be applied), for example, when algorithm 50 analyzes ultrasound-based image data to confirm that a sufficient change has occurred in the tissue properties.

[0149] In some embodiments, energy delivery by one or more components of System 10 (such as devices 100, 200, and / or 300) is configured to be manually activated by an operator (e.g., "turned on" or simply able to start energy and / or force delivery, and / or "turned off" or disabled energy and / or force delivery), for example, System 10 is activated by the patient before the patient goes to sleep and / or by the patient's clinician when it is determined that therapeutic energy delivery should be started. Alternatively or additionally, System 10 may be configured to be automatically activated. For example, System 10 can start or enable energy delivery (e.g. by CEDD200) and / or force delivery (e.g. by FAD300) at a specific time of day (such as at night when the patient usually goes to sleep) and / or when an assessment of the patient's physiological parameters indicates that energy delivery is needed (for example, when System 10 determines, via sensors and algorithms 50, etc., that the patient is asleep and / or snoring). Alternatively, the system 10 may automatically stop the delivery of energy and / or force based on, for example, specific times of day and / or the patient's physiological parameters (e.g., algorithm 50 determines whether the patient is awake, has stopped snoring, and / or otherwise does not need to receive energy delivery). In some embodiments, the system 10 is configured to deliver energy (e.g., by CEDD200) and / or apply force (e.g., by FAD300) during specific patient activities, for example, while speaking and / or singing, to move the muscles used while speaking and / or singing.

[0150] System 10 may operate in a closed-loop mode in which changes to energy delivery (e.g., frequency, amplitude, waveform, selection of energy delivery elements to deliver energy, and / or changes to other energy delivery parameters) are made when undesirable energy delivery conditions are encountered. Undesirable energy delivery conditions include, but are not limited to, tissue temperatures and / or the temperatures of parts of System 10 components outside the desired temperature range (e.g., above the maximum temperature and / or below the minimum temperature), the amount of tissue excised per unit time at an unacceptable rate, the amount of time energy is delivered (e.g., to a single location) above a threshold, tissue states and / or changes in states at undesirable levels (e.g., elastic states), and combinations thereof.

[0151] The FAD300 may be configured to operate in a closed-loop mode, as described herein, such as when one or more sensors in system 10 provide patient and / or system information and use it to adjust the FAD300, for example, to adjust the force applied by the FAD300 to a target tissue. In some embodiments, system 10 is configured to detect and / or predict undesirable sleep conditions, such as snoring and / or apnea events, and system 10 is configured to adjust the FAD300 (e.g., via algorithm 50) to stop, limit, and / or prevent undesirable sleep conditions. As described above, the FAD300 may include an EDM350, which may be configured to operate in a closed-loop mode of energy delivery, similar to those described above with reference to EDM150 and EDM250.

[0152] In some embodiments, energy delivery by EDD100 and / or CEDD200 during a tissue reduction procedure is provided in a closed-loop mode based on measurements of parameters (e.g., by one, two, or more sensors of System 10), the parameters being selected from a group consisting of temperature, for example, tissue temperature and / or temperature of a portion of the components of System 10 (such as a portion of EDD100 and / or CEDD200), patient movement and / or patient position (e.g., when the source and / or direction of energy delivery is changed to compensate for patient movement), patient physiological parameters, patient environmental parameters, parameters of System 10, and combinations thereof. In some embodiments, energy delivery by EDD100 and / or CEDD200 is provided in a closed-loop mode based on tissue ablation analysis, as described herein. For example, System 10 may be configured to stop energy delivery when a sufficient level of tissue ablation has been achieved (e.g., when recognized by algorithm 50, for example, by using image data IDs collected by one or more components of System 10, such as EDM150 and / or EDM250 described herein).

[0153] In some embodiments, energy delivery by the EDD100 and / or CEDD200 during tissue augmentation procedures is provided in a closed-loop mode based on measurements of parameters (e.g., by one, two, or more sensors of the system 10), the parameters being selected from a group consisting of temperature, such as tissue temperature and / or the temperature of a portion of the components of the system 10 (such as a portion of the EDD100 and / or CEDD200), patient movement (such as when the direction of energy delivery is changed to compensate for patient movement), patient physiological parameters, such as blood pressure, heart rate, and / or respiratory rate, patient sleep parameters (such as snoring level, patient posture during sleep, and / or other sleep parameters described herein), parameters of the system 10, and combinations thereof.

[0154] The EDD100 may be configured to both image tissue and perform tissue reduction or other tissue therapeutic procedures (such as tissue therapeutic procedures performed on at least a portion of the imaged tissue) as described herein. Image data IDs generated during imaging may be used by the operator (e.g., manually) and / or automatically by the system 10 (e.g., via algorithm 50) to distinguish between target tissue to be treated and non-target tissue to be avoided (e.g., to avoid delivery of sufficient energy to cause necrosis or other volume reduction effects). For example, target tissue to be treated with a tissue reduction procedure may include adipose tissue (such as adipose tissue of the tongue or other airway tissue), and non-target tissue to be avoided may include vascular tissue, nerve tissue, and / or muscle tissue (such as non-target tissue adjacent to adipose tissue being treated by reduction and / or other methods). A treatment plan may be generated using the image data IDs (e.g., by the system 10 via AI-based or other form of algorithm 50) that delivers an energy pattern (such as relatively short bursts of ultrasound energy) to liquefy the adipocytes of the target tissue while avoiding damage to adjacent non-target tissue. In some embodiments, both adipose tissue and small portions of muscle tissue are treated (e.g., causing coagulative necrosis of muscle tissue), for example, when additional treatment of muscle tissue enhances the therapeutic effect on the patient (e.g., a patient with sleep apnea). In some embodiments, non-target tissues include vascular tissue, nerve tissue, and / or mucosal tissue (e.g., mucosal tissue of the airway), and the system 10 is configured to analyze image data IDs to create a treatment plan that excises the intended target tissue (e.g., adipose tissue and / or muscle tissue) while avoiding damage to these types of non-target tissues.

[0155] The EDM150 of the EDD100 may be configured to be positioned at location L100, accessible through the patient's mouth (e.g., as shown in Figure 18B) and / or nose (e.g., as shown in Figures 13 and 19). For example, the EDM150 (including an array of ultrasound transducers, etc.) may be advanced through the patient's mouth and / or nostrils so that tissue treatment (such as ablation and / or stimulation treatment) can be performed on the patient's tongue, soft palate, tonsils, airway muscle tissue, and / or other airway tissues. Alternatively or additionally, the EDM150 may be positioned on the patient's skin, for example, on the skin located under the patient's jaw (e.g., as shown in Figure 12), to deliver therapeutic energy to the tongue and / or geniolingus tissue (without requiring the patient's mouth to be kept open during the procedure, etc.).

[0156] In some embodiments, System 10 is configured to perform medical procedures to treat a patient's sleep apnea, such as when the target tissue includes airway tissue as defined herein. In these embodiments, the target tissue may be treated using tissue reduction procedures (e.g., procedures in which airway tissue is excised using EDD100 and / or CEDD200), tissue augmentation procedures (e.g., procedures in which airway tissue is stimulated using EDD100 and / or CEDD200), and / or procedures in which force is applied to the tissue (e.g., using FAD300). In some embodiments, at least two of EDD100, CEDD200, or FAD300 are used to treat a patient with sleep apnea in a single clinical procedure or multiple clinical procedures. In some embodiments, at least one EDD100, at least one CEDD200, and at least one FAD300 are used to treat a patient with sleep apnea in a single clinical procedure or multiple clinical procedures.

[0157] As described herein, System 10 may be configured to perform a series of clinical procedures on patients such as those with sleep apnea. In some embodiments, System 10 is configured to perform a first procedure that reduces the volume of at least the tonsil tissue (such as by ablation using the EDD100 described herein or by other tissue reduction procedures), and a second procedure (e.g., following the first procedure) in which muscle strengthening is performed (such as muscle strengthening performed by delivery of stimulating energy or by other tissue augmentation procedures described herein). In some embodiments, the system 10 is configured to perform a first procedure (such as a surgical procedure and / or a procedure in which bone is removed and / or weakened using energy delivered by the EDD 100) in which a jaw extension procedure is performed, and then a second procedure (e.g., following the first procedure) in which the system 10 is used to excise airway tissue (e.g., the tongue, tonsils, and / or other airway tissue is excised using the EDD 100), stimulate the airway tissue (e.g., via the CEDD 200), and / or apply force to the airway tissue (e.g., via the FAD 300). In some embodiments, the system 10 is configured to perform a first procedure (e.g., via ablation and / or other energy delivery by the EDD 100) in which at least the volume of the patient's tongue is reduced, and then a second procedure (e.g., following the first procedure) in which at least the patient's tongue is applied (e.g., via the FAD 300). In some embodiments, the system 10 is configured to perform a first action to reduce the volume of airway tissue (e.g., reducing the tongue, tonsils, and / or other airway tissue using the EDD 100), a second action (e.g., following the first action) in which the upper airway tissue is tensed or otherwise strengthened (e.g., tensing or other strengthening of the upper airway muscles related to the maxilla, performed using the EDD 100), and a third action (e.g., following the first and / or second action) in which stimulating energy is delivered to the airway tissue and / or force is applied (e.g., via the CEDD 200 and / or FAD 300, respectively).In some embodiments, the system 10 is configured to perform a first procedure in which the volume of at least the tonsil tissue is reduced (for example, by ablation using the EDD 100 described herein or by other tissue reduction procedures), and then a second procedure (for example, following the first procedure) in which force is applied to the airway tissue (for example, via the FAD 300).

[0158] In some embodiments, System 10 is configured to treat patients with sleep apnea using a treatment device 930, such as a CPAP machine and / or an oral appliance. In these embodiments, System 10 may enhance the effectiveness of the treatment device 930 by utilizing one or more of the EDD100, CEDD200, and / or FAD300. For example, a patient using CPAP at a first level (e.g., a first pressure level or airflow level) may receive treatment using System 10 (e.g., airway tissue ablation or other procedures described herein), after which the patient may avoid using CPAP (e.g., to avoid further serious side effects of sleep apnea) or use their CPAP at a second level lower than the first level (e.g., a pressure level and / or airflow level lower than the level used before treatment using System 10). In some embodiments, the patient is taking one or more medications before treatment with System 10 is performed, and the patient's use of medications is reduced or avoided after one or more treatments using System 10 are performed, as described herein.

[0159] The EDD100 can be used to perform tissue reduction procedures on a patient's airway tissue, such as the tonsil tissue of a patient (e.g., a patient with sleep apnea), via energy delivered by the EDM150 (such as HIFU or other ultrasound energy). In some embodiments, the system 10 is configured to reduce a significant portion of the tonsil tissue volume by removing, for example, at least 50% of the pre-treatment tonsil volume, but not exceeding 90% or 95% of the pre-treatment volume. In other embodiments, the system 10 is used to reduce the tonsil volume, leaving at least 20%, 30%, 40%, 50%, and / or 80% of the pre-treatment tonsil volume, while providing improvement in the patient's symptoms (e.g., improvement in sleep apnea, which may occur due to tonsil tissue contraction over time, as described herein). In these embodiments, the actual reduction in tonsil volume may occur over time, for example, over a period of at least one day, at least one week, and / or less than one month. In some embodiments, all treated (e.g., reduced) tissue includes the subcutaneous tissue of the tonsil, in other words, the surface tissue of the tonsil is left untreated, and treatment of the subcutaneous tissue (e.g., excision and / or liquefaction) results in a reduction in the overall volume of the tonsil. In these embodiments, the EDD100 may include a cooling element (e.g., functional element 199 and / or spacer 251 include the cooling element) so that the subcutaneous tissue can be excised, while the surface tissue (e.g., cooled before, during, and / or after energy delivery) is not adversely affected. In some embodiments, the tonsil is treated using an EDM150 which includes a capture portion, and the tonsil is drawn into and / or positioned within the capture portion (e.g., as described with reference to Figures 9, 10 and / or 11 of this specification). In some embodiments, a vacuum (e.g., supplied by console 500 and / or functional element 199 of the EDD100) is applied to the capture portion of the EDM150 to draw the tissue to be treated into the capture portion. In some embodiments, the target tissue to be treated includes tonsil tissue that is drawn into the capture portion of the EDM150 (for example, via a vacuum), and the tonsil tissue is separated from the muscle tissue by the movement of the tissue.In other embodiments, the target tissue, including the tonsils, is left in place (e.g., not separated from the non-target tissue), and the non-target tissue (such as muscle tissue adjacent to the target tonsils) is avoided by the precision of energy delivery (e.g., HIFU delivery is performed while simultaneously imaging the target and non-target tissues).

[0160] In some embodiments, the EDD100 is configured to reduce the volume of airway tissue located in close proximity to muscle tissue that will not be adversely affected (such as tonsil tissue, which will be subjected to volume reduction and is located in front of muscle tissue that should not be resected). In these embodiments, the EDD100 may include an array of ultrasonic transducers (such as CMUT and / or piezoelectric transducers) that deliver ultrasonic energy (such as plane-wave ultrasonic energy) at a target frequency (such as about 6 MHz) configured to resect a specific thickness of tissue (such as 8-10 mm) while avoiding adverse effects on deeper tissues. In some embodiments, the target tissue has a specific thickness, and the non-target tissue is located behind the target tissue. In these embodiments, the EDD100 may be configured to resect the inner portion of the target tissue thickness (such as 80% or less of the total thickness) to avoid adverse effects on non-target tissue (such as muscle tissue and / or nerve tissue) located beneath the target tissue being treated (e.g., having its volume reduced). In some embodiments, the EDD100 is configured to excise target tissue (such as tonsil tissue) while using image data IDs (such as real-time image data) collected by the EDD100 to avoid damage to non-target tissue (such as the muscular bed beneath the tonsils). In these embodiments, the EDD100 may include an array of ultrasonic transducers (such as CMUTs and / or piezoelectric transducers) that deliver focused ultrasonic energy (such as HIFU) to the target tissue while avoiding undesirable temperature increases in the non-target tissue (e.g., using geometric information and / or tissue temperature information in the image data IDs).

[0161] The EDD100 can be used by an operator to reduce the volume of adipose tissue as described herein, for example, adipose tissue adjacent to the patient's airway that contributes to the patient's sleep apnea. For example, adipose tissue of the tongue, tonsils, and / or the luminal walls of the airways can be reduced by energy delivered via the EDM150. The adipose tissue to be treated may include fat at the back of the tongue, fat in the walls of the patient's airways (such as along the pharyngeal walls), and / or fat of the soft palate. In some embodiments, the energy delivered by the EDM150 (such as ultrasonic energy) may be configured to liquefy the adipose tissue by delivering the energy in a manner that avoids tissue excision (for example, by avoiding use at high temperatures for a considerable period of time, such as by avoiding prolonged exposure to temperatures above 43°C or exposure above 60°C).

[0162] System 10 may be configured to modify the shape of the airway segments in the patient's nasal cavity, for example, through the delivery of energy by EDD100 and / or CEDD200. For example, EDM150 of EDD100 is positioned in and / or near the surface of the nasal tissue and can perform therapeutic procedures on the nasal tissue (as described, for example, with reference to Figures 13 and 19 of this specification). The energy delivered by EDM150 (such as HIFU and / or other ultrasonic energy) may be delivered to create holes in the nasal septum, soften the nasal septum, or both, so that the nasal septum may be reshaped (for example, over time) to increase the volume of the patient's airway near the nasal septum. In some embodiments, EDM150 is configured to perform tissue modifications selected from a group consisting of creating one or more holes in the nasal septum, thinning or reducing the volume of cartilage adjacent to the nasal cavity, softening and / or reducing the hardness of bone and / or cartilage near the nasal passage, and combinations thereof. In some embodiments, the EDM 150 is configured to improve sleep apnea symptoms by creating a hole in the nasal septum and / or delivering energy to soften the nasal septum, for example, to reshape the nasal passages and / or otherwise facilitate reshaping ("reshape" as used herein). In some embodiments, after therapeutic energy is delivered by the EDM 150, a therapeutic device 930 including an expandable structure (e.g., a balloon filled with room temperature and / or heated fluid, and / or another structure that can be expanded and / or deliver heat) is inserted near the therapeutic segment of the airway to reshape that segment and maintain its new shape. In some embodiments, after therapeutic energy is delivered by the EDM 150, a therapeutic device 930 including one or more stents (e.g., temporary stents) is positioned within and / or near the therapeutic segment of the airway to reshape that segment and maintain its new shape. In these embodiments, the stent-based therapeutic device 930 may be removed after periods of up to three months, one month, and / or one week.In some embodiments, energy delivery is performed by a pair of devices positioned on both sides of the nasal septum, for example, when an EDM 150a is positioned on one side of the septum and a mirror 155 is positioned on the other side of the septum (as illustrated, for example, with reference to Figure 19 of this specification), or when a first EDM 150a and a second EDM 150b are positioned on both sides of the septum, and either or both are capable of delivering energy (e.g., ultrasonic energy) to the septum.

[0163] In some embodiments, at least the FAD300 is used to treat patients with sleep apnea (for example, the EDD100 and / or CEDD200 may also be used to treat patients). The FAD300 may be positioned close to the airway tissue so that the FAA360 can scaffold the airway (e.g., move the tissue out of the airway) and / or the FAA360 can tense, strengthen, and / or otherwise enhance the airway tissue (e.g., the muscular tissue of the airway tissue). In some embodiments, the FAD300 may be attached to a pterygoid hook so that, when activated, the FAA360 rotates to tense the muscular tissue of the airway (e.g., to treat sleep apnea based on the soft palate). The FAA360 may be positioned to apply force to the tissue of the tensor veli palatini muscle, for example, to move the tissue back and forth. In some embodiments, the FAA360 may be positioned to apply force to the tissue in one, two, three, or more directions. In some embodiments, the FAA360 is positioned to apply force to one, two, three, or more tissues selected from a group consisting of the tensor veli palatini muscle tissue, the levator veli palatini muscle tissue, the genioglossus muscle tissue (e.g., for pulling the tongue forward), the internal nasal flap tissue, the tongue tissue (e.g., for causing contraction when force is applied), and combinations thereof.

[0164] System 10 may be configured to deliver transfacial energy to the tissues beneath the skin through the patient's skin surface, for example, via energy delivery by EDD100 and / or CEDD200, as illustrated with reference to Figure 14 of this specification. In these embodiments, System 10 may be configured to deliver energy to the facial muscles, fat, and / or bones of the patient. In some embodiments, EDD100's EDM150 delivers energy to reduce the volume of bone tissue and / or at least weaken it, for example, to perform a subsequent stretching osteoplasty maxillary expansion (DOME) procedure in patients with sleep apnea.

[0165] System 10 may be configured to perform treatment on a patient (such as a patient with sleep apnea) and may include the execution of a series of treatment plans, each of which may use one or more components of System 10 (e.g., one or more of devices 100, 200, and / or 300) used to perform one or more diagnostic procedures and / or one or more therapeutic actions. In some embodiments, System 10 is configured to perform treatment plans as described with reference to Figure 3 of this specification. An execution of an “initial treatment plan” performed using System 10 may be based on the patient’s current physiological state (e.g., current sleep apnea symptoms) and any previous treatments performed (e.g., using System 10 or other methods). Each “subsequent treatment plan” may also be based on the current physiological state and all previously performed treatments.

[0166] In some embodiments, the initial treatment plan may include using the system 10 to perform one or more tissue reduction procedures, one or more tissue augmentation procedures, or at least one tissue reduction procedure and at least one tissue augmentation procedure. For example, an initial treatment plan may include one, two, or more of the following: tissue resection procedures performed on soft tissues, such as the adenoids, palatine tonsils, lingual tonsils, inferior turbinates, and / or lingual adipose tissue; tissue deformities performed on hard tissues, such as anterior septoplasty performed using EDD100 or other methods, and / or deformities (such as distraction procedures) performed on the maxilla (such as the piriform margin of the maxilla and / or the lateral buttress of the maxilla) using EDD100 or other methods; and strengthening procedures performed on the muscles of the tongue (such as the intrinsic muscles of the tongue) and / or muscle strengthening procedures such as uvulopalatopharyngoplasty (UPPP) performed on upper airway tissues (such as the tensor veli palatini, levator palatini, palatopharyngeal, palatoglossus, geniohyoid bone, and / or geniohyoid bone tissue).

[0167] A second treatment plan (such as one determined after the first treatment plan described above has been performed) may include a treatment plan that includes tissue strengthening procedures (such as those performed using devices 100 / 200 / 300). For example, the second treatment plan may include muscle strengthening procedures such as nerve stimulation procedures (e.g., via energy delivery from CEDD200) in which the trigeminal nerve (cranial nerve V, CN V), hypoglossal nerve (cranial nerve XII, CN XII), and / or vagus nerve (cranial nerve X, CN X) are stimulated (unilateral and / or bilateral, e.g., via intraoral and / or cervical approaches). Alternatively or additionally, the muscle strengthening procedures of the second treatment plan may be performed by applying force to one or more muscles (such as the nerve-related muscles described above) via one or more forces applied by FAD300, for example, as described herein.

[0168] A third treatment plan (such as one determined after the second treatment plan described immediately above has been performed) may include tissue stabilization and / or dilation procedures. In some embodiments, the FAD300 or treatment device 930 (e.g., including a vibration reduction implant) may be placed in or at least near the soft palate or other airway location. In some embodiments, the third treatment plan may include placing the FAD300 in and / or near airway tissue to form an airway scaffold, strengthen and / or enhance airway muscle tissue, and / or provide other therapeutic benefits. In some embodiments, all or part of the implanted FAD300 is configured to remain in the patient's body for at least one week, one month, and / or three months. In some embodiments, all or part of the implanted FAD300 is configured to be reabsorbed, for example, components are configured to be absorbed after at least one week, one month, and / or three months.

[0169] In some embodiments, the first, second, and / or third treatment plans described above are performed in any order. In some embodiments, one of the first, second, or third treatment plans is not performed on the patient.

[0170] In some embodiments, the system 10 includes a functional element 999 which includes sensors implanted in the patient and configured to detect the patient's respiration, for example, sensors located near the lungs, in the external and internal intercostal muscles (e.g., between the external and internal intercostal muscles), and / or other locations beneath the patient's skin. In some embodiments, the functional element 999 includes sensors located outside the patient, for example, on or near the patient's skin, and configured to detect the patient's respiration. In these embodiments, the CEDD 200 and / or FAD 300 are configured in a closed-loop mode and can adjust the delivery of energy and / or force, respectively, based on the patient's respiration via the algorithm 50 described herein. For example, the CEDD 200 via the EDM 250 may be configured to deliver adjustable energy to the hypoglossal nerve (for example, to cause tongue protrusion).

[0171] In some embodiments, the EDD100 and / or CEDD200 are configured to deliver ultrasonic energy to interact with a drug (such as the agonist 920) delivered to a patient, as described herein. The interaction may include drug release (such as from a carrier) and / or other activation, and / or the interaction may include enhancement of the drug's effect. In some embodiments, the drug includes one or more visible components (such as radiolucent components and / or ultrasonic reflective components) which the system 10 uses to locate the drug and then precisely deliver ultrasonic energy to induce the interaction.

[0172] In some embodiments, the EDD100 and / or CEDD200 are configured to deliver energy to treat a patient's cyst. In some embodiments, energy is delivered to relatively small cysts to image and / or treat them (e.g., excise the entire cyst or at least reduce its volume). In some embodiments, larger cysts are treated to drain fluid from the cyst (e.g., via the treatment device 930), after which energy is delivered to image and / or treat the cyst.

[0173] In some embodiments, the FAD300 includes at least one portion (such as the FAA360) that is implanted in the patient's implant site (such as the L300 described herein) and selected to treat subglottic stenosis (such as stenosis resulting as a complication of the patient's previous intubation). In these embodiments, the FAA360 may be fixed to the laryngeal cartilage (e.g., scaffolding of the stenosis) such that one or more actuators of the FAA360 apply force to the stenosis.

[0174] The FAD300 may include at least one portion (such as the FAA360) that is implanted in the patient at an implant site selected to treat pelvic organ prolapse and / or urinary incontinence (such as the L300 described herein). One or more actuators of the FAA360 may be configured to apply force to one or more tissue sites (such as one or more volumes of target tissue) to treat pelvic organ prolapse and / or urinary incontinence. The FAA360 may typically be configured in an unfolded state (e.g., elastically biased) (e.g., energy is minimal or not consumed at all while applying force to the tissue, and energy is added to transition to an unfolded state). Alternatively or additionally, the FAA360 may typically be configured in an unfolded state (e.g., elastically biased) (e.g., energy is added to the FAA360 to transition to an unfolded state). In some embodiments, one or more actuators of the FAA360 may be positioned to apply force to tissue (such as urethral tissue) to prevent unwanted urine leakage. In these embodiments, the FAA360 can typically be configured (e.g., elastically biased or otherwise configured) in an extended state (e.g., with actuators extended to apply force to tissue), and the patient can transition the FAA360 to an unextended state (e.g., by retracting one or more actuators of the FAA360 to stop applying force to tissue) (via the externally located user interface 390 and / or other user interfaces described herein) to allow urination.

[0175] System 10 may be configured to provide treatment to the patient's lungs, for example, by improving airflow through one or both of the patient's lungs. In some embodiments, System 10 is configured to measure positive end-expiratory pressure (PEEP) before, during, and / or after treatment of the patient's lungs. In these embodiments, PEEP may be measured via an imaging device 910 including an EDD 100 and / or an ultrasound imaging device. For example, EDM 150 may include an array of ultrasound transducers configured to generate image data IDs, from which PEEP measurements can be determined (for example, via algorithm 50). Using the PEEP measurements, a treatment plan can be created as defined herein, and for example, one or more energy delivery settings of EDM 150, e.g., one or more energy delivery settings related to tissue reduction procedures (such as tissue resection procedures) and / or tissue augmentation procedures (such as tissue stimulation procedures), can be set and / or modified ("set" as herein). Alternatively or additionally, PEEP measurements can be used to predict the outcome of treatment by System 10 (for example, Algorithm 50 can predict the outcome of the treatment before, during, and / or after the treatment is completed).

[0176] Referring here to Figure 2, a flowchart of a method for providing treatment in a closed-loop configuration consistent with the concept of the present invention is shown. Method 2000 may comprise several steps, which are performed automatically and / or semi-automatically ("automatically" as herein) to deliver energy (such as stimulating energy) and / or provide treatment in a form that varies based on one or more measured patient physiological parameters, patient environmental parameters, and / or other parameters. Method 2000 in Figure 2 is illustrated using System 10 and its components of the concept of the present invention.

[0177] In step 2010, the EDD100 and / or CEDD200 (referred to herein individually or collectively as “Device 100 / 200”) are positioned in close proximity to target tissue (such as one or more volumes of patient tissue), and the Device 100 / 200 is configured to deliver energy to the target tissue (e.g., to stimulate and / or treat the target tissue). The Device 100 / 200 may be implanted in the patient’s tissue and / or placed on a tissue surface (such as the patient’s skin and / or the inner layer of the patient’s airway). In step 2010, the Device 100 / 200 may be delivering energy to the patient or may be in “standby” mode, not delivering energy.

[0178] In step 2020, the device 100 / 200 and / or another component of system 10 monitors one or more patient parameters. Patient parameters may be recorded by sensor-based functional elements, e.g., functional elements 199, 299, 599, and / or 999 described herein. In some embodiments, patient parameters include one, two, or more parameters selected from a group consisting of blood pressure, heart rate, respiratory rate, snoring parameters (e.g., snoring level), sweat, patient posture (e.g., supine, lateral, and / or prone while sleeping), blood gas levels, blood glucose levels, and combinations thereof. In some embodiments, patient parameters may include parameters that can be recorded (e.g., measured by one, two, or more sensors) and / or provided by the patient's wearable devices, e.g., smartwatches, activity recorders (e.g., worn on the patient's wrist), and / or other portable devices. In some embodiments, the patient's respiratory rate is measured by a sensor including wired or wireless sensors (such as sensor-based functional elements 299, 399, and / or 999).

[0179] In step 2030, one or more patient parameters recorded by system 10 may be analyzed (e.g., by algorithm 50) to determine whether they exceed a threshold. The threshold may include the minimum or maximum level of one or more patient parameters. Alternatively or additionally, the threshold may be associated with a mathematical combination of two or more patient parameters. The threshold used in step 2030 may be associated with the levels of one, two, or more patient parameters that correlate with an ineffective or undesirable level of stimulus or other energy currently being delivered by device 100 / 200 (e.g., an energy delivery level that should be changed or discontinued).

[0180] If the threshold is not exceeded, method 2000 continues monitoring the patient parameters in step 2020 (without changing, for example, the current energy delivery or other treatment settings). If the threshold is exceeded, method 2000 proceeds to step 2040.

[0181] In step 2040, the modified set of energy delivery settings and / or other treatment settings is determined, for example, automatically by system 10 and / or manually by the operator of system 10 (e.g., the patient and / or the patient's healthcare professional). In some embodiments, the modified set of treatment settings includes stopping energy delivery by device 100 / 200 (e.g., turning off stimulation). In some embodiments, the modified new set of energy delivery settings and / or other treatment settings is determined based on one or more patient parameters recorded in step 2020 and / or previous data (e.g., about the current patient and / or other patient populations) collected using system 10. For example, algorithm 50 (such as an AI algorithm) may determine a new set of treatment settings based on parameters selected from the following groups, which consist of current patient parameters, previous patient parameters (such as parameters from the same patient and / or one, two, or more different patients treated using system 10), changes in patient parameters (such as the magnitude of changes in patient parameters), current energy delivery settings, previous energy delivery settings (such as previous energy delivery parameters used for the same patient and / or one, two, or more different patients treated using system 10), and combinations thereof. Once new energy delivery settings and / or other treatment settings are determined, treatment is provided with those settings (e.g., energy is delivered with those settings), method 2000 continues monitoring the patient parameters in step 2020, and method 2000 is repeated periodically.

[0182] In some embodiments, the delivery of energy by the device 100 / 200 in method 2000 can be stopped at any time (for example, by the patient via control on the user interface of system 10, and / or by system 10 when system parameters or patient parameters exceed a threshold).

[0183] In some embodiments, the system 10 is configured to change the treatment settings, including non-energy delivery settings, if a threshold is exceeded when determined in step 2030 by performing an action selected from the following groups, which include waking the patient (e.g., via an audible or tactile alarm provided by a functional element 999 and / or a consumer device 940, including a mobile phone, tablet, computer, alarm clock, bed shaker, and / or other alarm function device), changing the patient's position (e.g., via an adjustable bed and / or other robotic patient manipulator), changing the patient environment (adjusting sunshades, air conditioning, heating, and / or sound devices), and combinations thereof. One or more of these actions may be performed in step 2030 (e.g., with or without a change in energy delivery settings).

[0184] In some embodiments, algorithm 50 is configured to analyze sounds produced by the patient during sleep (such as snoring and / or other breathing sounds) via one or more sensors of system 10. In these embodiments, algorithm 50 is configured to distinguish the patient's sounds (such as snoring) from other sounds in the room (e.g., sounds from people or other animals in the room, or sounds from the television) that may be further recorded by the sensors, and the comparison with a threshold performed, for example, in step 2030, may be based on snoring signals received only from the patient using system 10. In some embodiments, system 10 includes two or more sensors used to record sounds emitted by the patient, and algorithm 50 distinguishes sounds from a particular patient based on the location of each sensor, the timing of the received signals (e.g., if the same snoring or other voice signal is received by two sensors at different times, the sensor that first received the signal is closer to the source of the sound), and / or other parameters of the multiple sensors recording snoring or other sleep sounds. In some embodiments, the sensor includes a sensor included in a functional element 999 having one, two, or more mobile phones and / or other consumer electronics capable of recording audio. In some embodiments, the algorithm 50 is configured to perform various signal processing techniques for recording, such as noise cancellation.

[0185] In some embodiments, the system 10 includes a set of multiple similar components (such as multiple devices 100 / 200 configured to record sleep sounds and / or multiple functional elements 999), and the system 10 is configured to be used to treat multiple patients (e.g., at least while sleeping) residing in a single room (such as a bedroom, hospital room, and / or barracks). For example, each of the multiple patients may have a device 100 / 200 implanted in their body or positioned to deliver energy (such as stimulating energy) during sleep. In these embodiments, the algorithm 50 may be configured to distinguish patient parameters (such as sleep sounds) based on the patient to whom the parameters apply, for example, based on the use of multiple sensors as described above.

[0186] Referring now to Figure 3, a flowchart of a method for treating a patient is shown, consistent with the concept of the present invention. Method 3000 includes multiple steps of treating a patient, such as steps including the performance of diagnostic procedures and / or therapeutic actions. Method 3000 in Figure 3 is illustrated using System 10 and its components of the concept of the present invention.

[0187] Step 3010 is performed, for example, a patient diagnostic procedure, which is performed using one or more devices of System 10 and is configured to determine a treatment plan for a patient having sleep apnea and / or another medical condition. The treatment plan may be determined by a clinician (such as an operator of System 10) and / or via an algorithm 50 of System 10, for example, an AI algorithm that utilizes the diagnostic data collected in step 3010. The diagnostic procedure may include obtaining the patient's medical history. The diagnostic data may include data collected through the performance of a procedure selected from a group consisting of a polysomnography procedure and a procedure for determining body weight and / or body mass index.

[0188] Step 3020 is performed, and the first treatment is part of the treatment plan determined in Step 3010. The first patient treatment may include tissue reduction and / or tissue augmentation procedures as described herein. The first patient treatment may include one or more treatments performed using System 10 or other methods, e.g., nasal treatment (e.g., adenoidectomy, turbinate reduction, septoplasty, and / or DOME treatment), soft palate treatment (e.g., tonsillectomy or tonsillar reduction, pharyngoplasty, tissue stimulation via EDD100 and / or CEDD200, and / or implantation of implants such as a treatment device 930 including a soft palate implant and / or FAD300, as described herein), and / or tongue treatment (e.g., lingual tonsillectomy, advancement of the genioglossus muscle or other tongue muscles, tissue stimulation via EDD100 and / or CEDD200, force supply treatment via FAD300).

[0189] In step 3030, an optional step may be performed to carry out a second patient diagnostic procedure. In embodiments in which step 3030 is performed, the treatment plan determined in step 3010 may be confirmed or modified (for example, based on additional diagnostic data collected in step 3030, for example, based on the treatment performed in step 3020).

[0190] In step 3040, the second patient treatment procedure is performed based on the treatment plan from step 3010 and / or the modified treatment plan from step 3030.

[0191] In some embodiments, the method 3000 shown in Figure 3 is performed on a patient with sleep apnea and includes the execution of at least two, at least three, or four of the following tissue therapy procedures: reduction of tonsil tissue volume, reduction of tongue tissue volume, tightening, strengthening, and / or tensioning of airway muscles, and stimulation of one or more nerves and / or muscles of the patient's airway. In some embodiments, the patient's adenoid tissue is treated. The tissue therapy procedures may be performed using one, two, or more of each of the devices 100, 200, and / or 300.

[0192] In some embodiments, Method 3000 includes additional treatments such as a third, fourth, etc., for example, the additional treatments include the implantation and subsequent use of CEDD200 (for irritation of airway tissue, etc.) and / or FAD300 (for application of force to airway tissue, etc.), as described herein, respectively.

[0193] In some embodiments, method 3000 includes introducing the EDM 150, 250, and / or 350 of device 100 / 200 / 300 through the patient's nostrils to treat the patient's adenoid tissue and / or other airway tissue, for example, as described herein.

[0194] In some embodiments, method 3000 includes treating adipocytes and / or other tissues of the tongue using, for example, an oral approach and / or access via the submental space.

[0195] In some embodiments, method 3000 includes transfacial energy delivery as described herein, for example, performing a DOME treatment without lifting the facial skin.

[0196] In some embodiments, the first treatment in step 3020 is performed in a first type of hospital setting (such as a "clinic"), and the second treatment in step 3040 is performed in a second type of hospital setting different from the first setting (such as an outpatient or other hospital setting).

[0197] In some embodiments, the second treatment in step 3040 includes a DOME procedure (such as a DOME procedure performed using the EDD100 of system 10). In these embodiments, the third treatment may include procedures such as those described herein, which include the implantation and subsequent use of the CEDD200 (e.g., for stimulating airway tissue) and / or the FAD300 (e.g., for applying force to airway tissue).

[0198] In some embodiments, the first treatment in step 3020 includes at least a reduction in the volume of tonsil tissue, and the second treatment in step 3040 includes stimulation of airway tissue (e.g., using an implanted CEDD200).

[0199] In some embodiments, after being treated with CPAP, the patient undergoes a first therapeutic procedure in step 3020, and subsequent therapeutic procedures (such as a second therapeutic procedure in step 3040) include the patient avoiding the need for CPAP or using CPAP at a lower pressure and / or rate level than that the patient was using before the initial therapeutic procedure (e.g., the first or other prior therapeutic procedure). In other words, CPAP is avoided or reduced by airway improvement and / or other therapeutic benefits provided by the prior therapeutic procedure. In some embodiments, the use of CEDD200 (e.g., to stimulate airway tissue) and / or FAD300 (e.g., to apply scaffolding force to airway tissue) results in the patient avoiding and / or reducing the level of CPAP.

[0200] Referring here to Figure 4, a lateral cross-sectional anatomical view of a long-term energy delivery device implanted in a patient to stimulate a nerve, consistent with the concept of the present invention, is shown. The CEDD200 in Figure 4 has a similar structure and arrangement to the CEDD200 described with reference to Figure 1 and / or this specification, and may include similar components. The CEDD200 in Figure 4 includes an implantable portion 2100 implanted in the patient, and an external portion 2500 positioned on the patient's skin adjacent to the implantation site of the implantable portion 2100 (e.g., positioned to be removable). The implantable portion 2100 includes a wrap 2110 (such as a flexible sheet and / or tubular structure) implanted to surround (e.g., partially surround as shown) the nerve N1. The wrap 2110 may include a flexible material such as polyvinylidene fluoride and / or polyvinylidene difluoride. The implantable portion 2100 further includes one, two, or more electrodes, i.e., electrodes 2120 (six of which are shown arranged on the wrap 2110). The implantable portion 2100 further includes one, two, or more ultrasonic transducers UST2199 (three of which are shown arranged on the wrap 2110). UST2199 may include one or more piezoelectric transducers, one or more CMUTs, and / or at least one piezoelectric transducer and at least one CMUT. In some embodiments, the wrap 2110 includes a piezoelectric film into which UST2199 is integrated. UST2199 includes an array of multiple piezoelectric transducers and / or other ultrasonic transducers, which are arranged to allow reception of ultrasonic energy from multiple directions (e.g., omnidirectional arrangement of transducers).

[0201] The external portion 2500 includes a housing, i.e., housing 2501, that surrounds the energy delivery module EDM2510. The EDM2510 may have a similar structure and arrangement to the EDM250 described herein. The EDM2510 may include an array of one, two, or more ultrasonic transducers UST2599 (26 elements shown as two arrays of 13 elements each) configured to deliver ultrasonic energy to the UST2199 of the embeddable portion 2100. The UST2599 may include one or more piezoelectric transducers, one or more CMUTs, and / or at least one piezoelectric transducer and at least one CMUT.

[0202] During treatment delivery, the EDM2510 delivers ultrasonic energy to the UST2199, which converts the ultrasonic energy into electrical energy. The electrode 2120 receives electrical energy from the UST2199 via the indicated conduit 2121, and the electrode 2120 delivers this electrical energy to the target tissue (e.g., nerve N1 in the illustration) (e.g., via an applied voltage). In this configuration, the waveform of the electrical energy delivered to the target tissue depends on the energy delivery waveform supplied by the EDM2510. In some embodiments, the implantable portion 2100 may include a controller (e.g., not shown, but similar in structure and arrangement to the controller 210 of the CEDD200) to use the electrical energy generated by the UST2199 to generate one or more different stimulation waveforms (e.g., stimulation waveforms independent of the energy delivery pattern supplied to the implantable portion 2100 by the external portion 2500) for delivery to the target tissue by the electrode 2120.

[0203] In some embodiments, the external portion 2500 includes a spacer 251 as shown in the illustration, for example, the spacer 251 described herein. In some embodiments, the implantable portion 2100 includes at least two separate implantable portions, for example, an implantable portion 2100 as shown in the illustration (located in close proximity to nerve N1) and a second implantable portion 2100', which is not shown but is located in close proximity to a different segment of nerve N1, or to a different nerve (such as a different nerve that performs a similar role or function) as described with reference to Figure 5 herein.

[0204] In some embodiments, the CEDD200 in Figure 4 is configured to operate in a closed-loop mode, as described with reference to Figures 1, 2, and other parts of this specification. For example, a controller 210 (including, for example, algorithm 50) may coordinate energy delivery in a closed-loop mode. In some embodiments, at least a portion of the controller 210 is included in an embeddable portion 2100, and as a result, the energy delivered by the embeddable portion 2100 can be coordinated in a closed-loop mode without control signals being transmitted from external components of the system 10. The controller 210 may include a battery, a saturator, and / or other energy storage elements so that electrical energy can be stored in the embeddable portion 2100. In some embodiments, energy is transferred to the embedded energy storage element via the transmission of electrical energy (e.g., via inductive coupling, capacitive coupling, delivery of high-frequency energy, etc.) and / or via the transmission of ultrasonic energy (e.g., ultrasonic energy received by one or more ultrasonic transducers and converted into electrical energy, as described herein). The controller 210 may include a voltage-controlled oscillator that controls the voltage of the electrical stimulation energy delivered by the electrodes 2120.

[0205] Referring here to Figure 5, a lateral cross-sectional anatomical view of a long-term energy delivery device implanted in a patient to stimulate a nerve, consistent with the concept of the present invention, is shown. The CEDD200 in Figure 5 has a similar structure and arrangement to the CEDD200 described in Figure 1 and / or herein, and may include similar components. The CEDD200 in Figure 5 includes a first implantable portion 2100a implanted in the patient, a second implantable portion 2100b also implanted in the patient, and an external portion 2500 positioned on the patient's skin adjacent to the second implantable portion 2100b (e.g., positioned to be removable). The first implantable portion 2100a includes a wrap 2110 implanted to surround (e.g., partially surround as shown) the nerve N1. Alternatively, the wrap 2110 may simply be positioned near or along the nerve N1 (for example, if the wrap 2110 includes a tubular structure, e.g., a flexible tubular structure including an array of ultrasonic transducers). The first embeddable portion 2100a further includes one, two, or more electrodes, i.e., electrode 2120 (six of which are shown arranged on the wrap 2110). The second embeddable portion 2100b includes one, two, or more ultrasonic transducers UST2199, i.e., housed within the housing 2101. UST2199 may include one or more piezoelectric transducers, one or more CMUTs, and / or at least one piezoelectric transducer and at least one CMUT. In some embodiments, the wrap 2110 includes a piezoelectric film into which UST2199 is integrated. UST2199 is electrically connected to electrode 2120 via a conduit 2121 (e.g., one, two, or more wires). UST2199 may include an array of multiple piezoelectric transducers and / or other ultrasonic transducers arranged to allow reception of ultrasonic energy from multiple directions (e.g., omnidirectional arrangement of transducers).

[0206] The external portion 2500 in Figure 5 has a similar structure and arrangement to the external portion 2500 in Figure 4 described above, and may include similar components.

[0207] During therapeutic delivery, the EDM2510 delivers ultrasonic energy to the UST2199, which converts the ultrasonic energy into electrical energy. The electrode 2120 receives the electrical energy from the UST2199 via the conduit 2121 and delivers this electrical energy to the target tissue (e.g., nerve N1 in the illustration). In this configuration, the waveform of the electrical energy delivered to the target tissue depends on the energy delivery waveform supplied by the EDM2510. In some embodiments, the implantable portion 2100 may include a controller (e.g., not shown, but similar in structure and arrangement to the controller 210 of the CEDD200) to use the electrical energy generated by the UST2199 to generate one or more different stimulation waveforms (e.g., stimulation waveforms independent of the energy delivery pattern supplied to the implantable portion 2100 by the external portion 2500) for delivery to the target tissue by the electrode 2120.

[0208] In some embodiments, the external portion 2500 includes an illustrated spacer 251. The spacer 251 may have a similar structure and arrangement to the spacer 251 described herein with reference to Figure 4 and elsewhere. In some embodiments, the CEDD 200 includes a third implantable portion, i.e., the illustrated portion 2100a', which may have a similar structure and arrangement to the first implantable portion 2100a. The third implantable portion 2100a' may include a wrap 2110' embedded to surround (e.g., partially surround as shown) the nerve N2 (for example, if the wrap 2110' includes a tubular structure, such as a flexible tubular structure including an array of ultrasonic transducers). The third implantable portion 2100a' may similarly include one, two, or more electrodes, i.e., electrodes 2120' (six of which are shown arranged on the wrap 2110). In some embodiments, the wraps 2110 and / or 2110' include a piezoelectric film into which the UST 2199 is integrated (e.g., in one or both of the wraps 2110 and 2110'). Similar to the electrode 2120 of the first implantable portion 2100a, during treatment, the electrode 2120' of the third implantable portion 2100a' can receive electrical energy from the UST 2199 via the conduit 2121, and these electrodes 2120' can deliver this electrical energy to tissue such as the illustrated nerve N2. Nerve N2 may include a nerve that performs a similar role or function to nerve N1. In some embodiments, nerve N2 includes a different segment of the same nerve N1.

[0209] In some embodiments, the CEDD200 in Figure 5 is configured to operate in a closed-loop mode as described herein with reference to Figures 1, 2, and others. For example, a controller 210 (including, for example, algorithm 50) can regulate energy delivery in a closed-loop mode. In some embodiments, at least a portion of the controller 210 is included in implantable portions 2100a and / or 2100b, so that the energy delivered by the implantable portion 2100a can be regulated in a closed-loop mode without control signals transmitted from external components of the system 10. Electrical energy can be stored in the implantable portion 2100 by including a battery, a saturator, and / or other energy storage element in the controller 210. The controller 210 may include a voltage-controlled oscillator to control the voltage of the electrical stimulation energy delivered by the electrodes 2120.

[0210] Referring here to Figures 6A and 6B, anatomical side-sections of a force supply device implanted in a patient to apply force to tissue are shown, consistent with the concept of the present invention. The FAD300 in Figures 6A and 6B has a similar structure and arrangement to the FAD300 described with reference to Figure 1 and / or elsewhere in this specification, and may include similar components. The FAD300 in Figures 6A and 6B is fixed to a first tissue location (e.g., bone B1 shown) and applies force to a second tissue location (e.g., target tissue such as muscle M1 shown). The FAD300 includes a substrate 3110, which has a first portion 3110a fixed to the tissue using fixing elements 3111 (e.g., bone anchors, sutures, staples, etc.). The substrate 3110 includes a second portion 3110b, which is configured to deflect and apply force to the target tissue. In Figure 6A, the second portion 3110b is shown in a non-deflected state, and in Figure 6B, the second portion 3110b is shown in a deflected state (e.g., angularly deflected compared to the state in Figure 6A). As described herein, the FAD300 may be configured to apply force to target tissue to alter the properties of the tissue (e.g., to strengthen muscle tissue) and / or to apply force to cause an increase in the cross-sectional area of ​​the airway.

[0211] The substrate 3110 may include an electromechanical assembly configured to change shape when voltage, temperature changes, and / or other drive signals are supplied. The substrate 3110 may include an electromechanical assembly comprising a piezoelectric film (such as a bimorph and / or unimorph), a shape memory metal and / or a shape memory polymer, and / or other components that can be remotely controlled to transition between a non-deployed state and a deployed (e.g., under applied force) state. In some embodiments, the substrate 3110 may include a Peltier element.

[0212] Referring here to Figure 7, a partially transparent anatomical diagram of a force supply device implanted in a patient to apply force to tissue is shown, consistent with the concept of the present invention. The FAD300 in Figure 7 has a similar structure and arrangement to the FAD300 described herein with reference to Figure 1 and / or elsewhere, and may include similar components. The FAD300 in Figure 7 includes a substrate 3110 implanted in the patient's airway as shown, and includes an intermediate portion 3110d and end portions 3110c and 3110e. Either or both of portions 3110c and 3110e may be configured to apply force (e.g., individually or in combination) to the opposite side of the airway, as shown in Figure 7. Force can be applied by the FAD300 to tissue continuously and / or intermittently, at constant and / or variable levels of force. Force can be applied to reinforce adjacent muscles and / or to form a scaffold for the airway.

[0213] Referring here to Figure 8, a cross-sectional anatomical diagram of an energy delivery device for delivering energy to tissue is shown, consistent with the concept of the present invention. The EDD100 in Figure 8 has a similar structure and arrangement to the EDD100 described herein with reference to Figure 1 and / or elsewhere, and may include similar components. The EDD100 in Figure 8 includes a housing 101 surrounding the EDM150 as shown. The EDM150 may include an array of ultrasound-based energy delivery elements (such as CMUT elements) and be configured to deliver focused ultrasound (such as HIFU) to one or more tissue targets (three in the illustration) of a patient's tonsils (e.g., tonsils implanted in other tissue), while avoiding energy delivery to tissues below and / or next to the tonsils (e.g., muscle tissue below and / or next to the tonsils).

[0214] Referring here to Figure 9, a side view of an energy delivery device for delivering energy to tissue captured by the device is shown, consistent with the concept of the present invention. The EDD100 in Figure 9 has a similar structure and arrangement to the EDD100 described herein with reference to Figure 1 and / or elsewhere, and may include similar components. The EDD100 in Figure 9 includes a housing 101 containing a channel, a cup-shaped capture portion 102 which is fluidly attached to the channel 103 in the illustration. The housing 101 may include a complete (as shown) or partial circumferential geometric shape. The EDD100 is configured to be operably mounted to a console 500 (not shown, but such as described herein) via a cable 501, so that the console 500 can apply vacuum via the cable 501 (such as the vacuum lumen of the cable 501) and the channel 103 to draw the tissue-proximity portion 102 into portion 102 (tissue T1 in the illustration). The EDD100 further includes an EDM150, which may include an array of energy delivery elements (such as a curved array of energy delivery elements as shown in Figure 9). The EDM150 can receive energy (such as electrical energy) from the console 500 via cable 501 (e.g., via one or more wires of cable 501) and then deliver energy (such as HIFU or other ultrasound energy) to tissue T1 trapped within section 102. Tissue T1 may include tissue located within the patient's airway, e.g., tonsil tissue and / or other tissues that constitute the patient's airway (e.g., also causing sleep apnea events in the patient).

[0215] Referring here to Figure 10, a perspective view of an energy delivery device for delivering energy to tissue captured by the device is shown, consistent with the concept of the present invention. The EDD100 in Figure 10 has a similar structure and arrangement to the EDD100 described herein with reference to Figure 1 and / or elsewhere, and may include similar components. The EDD100 in Figure 10 includes a housing 101, which includes a cone-shaped capture portion 102 that is fluidly attached to a channel, in the illustration, channel 103. The housing 101 may include a complete (as shown) or partial circumferential geometric shape. In some embodiments, the capture portion 102 includes a tubular capture portion. The EDD100 is configured to be operably attached to a console 500 (not shown, but as described herein) via a cable 501, so that the console 500 can apply vacuum via the cable 501 (e.g., a vacuum lumen of the cable 501) and channel 103 to draw the tissue-proximity portion 102 into the cone-shaped geometric shape of portion 102. The EDD100 further includes an EDM150, which may include an array of energy delivery elements (e.g., a partial or complete circumferential array of energy delivery elements as illustrated). The EDM150 can receive energy (e.g., electrical energy) from the console 500 via cable 501 (e.g., via one or more wires of cable 501) and then deliver energy (e.g., HIFU or other ultrasound energy) to the tissue trapped within section 102. In some embodiments, the EDM150 includes a full-circumferential or nearly full-circumferential (e.g., more than 270°) array of energy delivery elements, so that energy (e.g., HIFU or other ultrasound energy) can be delivered to the tissue trapped within section 102 from a full-circumferential or nearly full-circumferential set of energy delivery elements. The tissue trapped within section 102 may include tissue located within the patient's airway, e.g., tonsil tissue and / or other airway tissue (e.g., tissue causing sleep apnea events in the patient). The tissue captured within portion 102 may include tissue from one or more different anatomical locations, for example, tissue that is part of an organ or other body tissue.

[0216] Referring here to Figure 11, a perspective view of an energy delivery device for delivering energy to tissue captured by the device is shown, consistent with the concept of the present invention. The EDD100 in Figure 11 has a similar structure and arrangement to the EDD100 described herein with reference to Figure 1 and / or elsewhere, and may include similar components. The EDD100 in Figure 11 includes a housing 101 containing a cylindrical capture portion 102. The housing 101 may include a complete (as shown) or partial circumferential geometric shape. The EDD100 is configured to be operably mounted to a console 500 (not shown, but as described herein) via a cable 501. The capture portion 102 may slide over the tissue to be treated (such as the tonsils or other tissue). The EDD100 further includes an EDM150, which may include an array of energy delivery elements (e.g., a partial or complete circumferential array of energy delivery elements as shown). The EDM150 can receive energy (such as electrical energy) from the console 500 via cable 501 (e.g., via one or more wires of cable 501) and then deliver energy (such as HIFU or other ultrasound energy) to the tissue trapped within section 102. In some embodiments, the EDM150 includes a circumferential or nearly circumferential (e.g., greater than 270°) array of energy delivery elements, so that energy (such as HIFU or other ultrasound energy) can be delivered to the trapped tissue from a circumferential or nearly circumferential set of energy delivery directions. The tissue trapped within section 102 and subsequently treated by the EDM150 may include tissue located within the patient's airway, e.g., tonsil tissue and / or other airway tissue (e.g., tissue causing sleep apnea events in the patient). The tissue drawn into section 102 may include tissue from one or more different anatomical locations, e.g., tissue that is part of an organ or other body tissue.

[0217] Referring here to Figure 12, a lateral cross-sectional anatomical view of an energy delivery device positioned on the skin under a patient's jaw to deliver energy to tongue tissue is shown, consistent with the concept of the present invention. The EDD100 in Figure 12 has a similar structure and arrangement to the EDD100 described herein with reference to Figure 1 and / or elsewhere, and may include similar components. The EDD100 in Figure 12 includes an EDM150 which may include an array of energy delivery elements configured to deliver energy to tissue. In some embodiments, the EDD100 is positioned at location L100 on the skin under a patient's jaw and configured to deliver energy (such as HIFU and / or other ultrasound energy) to the patient's tongue and / or other airway tissues. The EDM150 may be configured to deliver energy to the tongue to reduce its volume and / or to perform other tissue treatments described herein. The EDM150 may be configured to be operably mounted to an energy source (e.g., mounted to a console 500 via cable 501, both not shown but described in detail herein). In some embodiments, the EDM150 may include an internal power source (such as a functional element 199 including a battery and / or other power components) and / or a controller (controller 110 as described herein) for supplying drive signals to the EDM150. In some embodiments, a tool 950 including a stabilization device is included to attach, for example, the EDD100 to the patient during energy delivery. In some embodiments, the EDD100 includes a spacer placed between the EDM150 and the patient's skin, for example, a spacer 151 as described herein.

[0218] In some embodiments, the EDD100 shown in Figure 12 is placed on the skin under the patient's jaw and is configured to image the patient's tongue tissue and / or other airway tissues (for example, when performing ablation procedures as described above, or simply to create image data IDs of the patient's tongue or other airway tissues).

[0219] Referring here to Figure 13, a lateral cross-sectional anatomical view of an energy delivery device advanced transnasally to position a transducer within the patient's airway is shown, consistent with the concept of the present invention. The EDD100 in Figure 13 has a similar structure and arrangement to the EDD100 described herein with reference to Figure 1 and / or elsewhere, and may include similar components. The EDD100 in Figure 13 includes a catheter-like geometric shape as illustrated, and may be configured to introduce the EDM150 into the patient's airway through the patient's nostril (i.e., an intranasal approach). The EDM150 may be configured to deliver energy (such as ultrasonic energy) to tissue to treat (e.g., reduce volume and / or harden) the patient's tongue, soft palate tissue, tonsil tissue, and / or other airway tissues.

[0220] Referring here to Figure 14, a frontal anatomical view of an energy delivery device positioned on a patient's face, consistent with the concept of the present invention, is shown. The EDD100 in Figure 14 has a similar structure and arrangement to the EDD100 described herein with reference to Figure 1 and / or others, and may include similar components. The EDD100 in Figure 14 includes a plurality of devices, namely a first device 100a and a second device 100b. Device 100a may include a tissue contact geometric shape different from that of device 100b (e.g., a rectangle with an aspect ratio greater than 1.5 as shown), for example, if the EDD100 includes a plurality of devices having different tissue contact geometric shapes configured to adapt to different locations on the patient (e.g., different locations on the patient's face as shown).

[0221] In some embodiments, the EDD100 is configured to allow an operator to perform maxillofacial surgery on a patient.

[0222] Referring here to Figure 15, a perspective view is shown of a system including an energy delivery device comprising a shaft and a distally positioned transducer having a diameter close to the diameter of the shaft, consistent with the concept of the present invention. The EDD100 in Figure 15 has a similar structure and arrangement to the EDD100 described herein with reference to Figure 1 and / or elsewhere, and may include similar components. The EDD100 in Figure 15 includes an EDM150 positioned at the distal end of an elongated housing 101 (such as pencil-shaped as shown). The diameter of the EDM150 is approximately the same as the diameter of the housing 101 (diameter D1 shown), so that the EDM150 can be introduced through a passage as small as diameter D1. The diameter of the EDM150 may be configured for insertion of the EDM150 through the patient's nostril (e.g., less than 10 mm or less than 6 mm in diameter). The EDD100 may include a functional element 199 including one or more controls, e.g., a button as shown (e.g., configured as an on / off control). The EDD100 is operably mounted to the console 500 via cable 501 as shown in the figure. The console 500 includes a user interface 590, a functional element 599, and an algorithm 50, as described herein.

[0223] Referring here to Figure 16, a perspective view is shown of a system including an energy delivery device comprising a shaft and a distally positioned transducer having a diameter larger than the diameter of the shaft, consistent with the concept of the present invention. The EDD100 in Figure 16 has a similar structure and arrangement to the EDD100 described herein with reference to Figure 1 and / or elsewhere, and may include similar components. The EDD100 in Figure 16 includes an EDM150 positioned at the distal end of an elongated housing 101 (such as pencil-shaped as shown). The diameter of the EDM150 (diameter D2 in the illustration) is larger than the diameter of the housing 101 (diameter D1 in the illustration), so the EDM150 may include a large array of energy delivery elements (e.g., a large array of piezoelectric and / or CMUT ultrasonic energy delivery elements). The EDD100 may include a functional element 199 including one or more controls, e.g., a button as shown (e.g., configured as an on / off control). The EDD100 is operably mounted to a console 500 via a cable 501 as shown. The console 500 includes a user interface 590, a functional element 599, and an algorithm 50, as described herein.

[0224] Referring here to Figure 17, a lateral cross-sectional anatomical view of an energy delivery device including an energy delivery module and a mirror, consistent with the concept of the present invention, is shown. The energy delivery device in Figure 17 may include an EDD100 (such as a clinical medical device used in clinical procedures) and / or a CEDD200 (such as an implant or extracorporeal device used in a patient for an extended period, as described herein). The EDD100 and / or CEDD200 in Figure 17 have a similar structure and arrangement and may include similar components to the EDD100 and / or CEDD200 described herein with reference to Figure 1 and / or elsewhere. The EDD100 and / or CEDD200 in Figure 17 (referred to herein individually or collectively as “Apparatus 100 / 200”) may include an energy delivery module, EDM150 / 250 (not shown, but integrated into EDM150 / 250), which includes one or more energy delivery elements, e.g., one or more piezoelectric transducers and / or CMUTs configured to deliver ultrasonic energy (such as HIFU or other ultrasonic energy) to a target tissue. Apparatus 100 / 200 may include a mirror 155 / 255 as illustrated and described herein. The mirror 155 / 255 (such as an acoustic mirror) may be positioned in close proximity to the target tissue (such as nerve N1 in the illustration) (e.g., implanted). The mirror 155 / 255 and EDM150 / 250 are positioned on either side of the target tissue (as shown), and the energy delivered by EDM150 / 250 and reaching the mirror 155 / 255 is reflected toward the target tissue. In some embodiments, the EDM150 / 250 is placed on the skin and the mirror 155 / 255 is implanted beneath the target tissue (e.g., beneath nerve N1, where N1 is located between the EDM150 / 250 and the mirror 155 / 255). In other embodiments, both the EDM150 / 250 and the mirror 155 / 255 are implanted in the patient (e.g., on both sides of the target tissue to be treated).

[0225] Referring here to Figures 18A-18B, top and side cross-sectional anatomical views of an energy delivery device consistent with the concept of the present invention are shown. The EDD100 in Figures 18A-18B has a similar structure and arrangement to the EDD100 described herein with reference to Figure 1 and / or elsewhere, and may include similar components. The EDD100 in Figures 18A-18B includes an energy delivery module, EDM150, having a spoon-shaped geometric form. The EDM150 may include a curved geometric form along one axis or multiple axes (as shown in Figure 18B). The EDM150 may include one or more piezoelectric transducers and / or one or more CMUTs configured to deliver ultrasonic energy. In Figures 18A-18B, the EDM150 is inserted through the patient's mouth and positioned on the patient's tongue to deliver energy for excision and / or treatment of tongue tissue, for example, as described herein.

[0226] Referring here to Figure 19, a lateral cross-sectional anatomical view of an energy delivery device inserted transnasally into a patient is shown, consistent with the concept of the present invention. The EDD100 in Figure 19 has a similar structure and arrangement to the EDD100 described herein with reference to Figure 1 and / or elsewhere, and may include similar components. The EDD100 in Figure 19 includes, as all illustrated, a first part 100a containing an energy delivery module EDM150 in its distal portion, and a second part 100b containing a mirror 155, which is an acoustic mirror, in its distal portion. The EDM150a includes one or more piezoelectric transducers and / or one or more CMUTs configured to deliver ultrasonic energy (such as HIFU and / or other ultrasonic energy). As shown in Figure 19, the distal portion of EDD100a is inserted into the patient's nasal passage through a first nostril, and the distal portion of EDD100b is inserted into the patient's nasal passage through the other nostril, with EDM150 and mirror155 positioned on either side of the portion of the patient's nasal septum S1 at position L100 as shown. EDM150 delivers energy to the tissue at position L100 to excise, soften, and / or otherwise treat the tissue of the nasal septum (e.g., as described herein). Mirror155 is configured and positioned to reflect back the ultrasonic energy passing through the tissue at L100 to that tissue. In some embodiments, EDD100b includes another energy delivery module (such as EDM150b) positioned in the location of mirror155 (e.g., instead of mirror155). In some embodiments, EDD100 includes only EDD100a and does not include EDD100b. The delivery of ultrasonic energy to L100 may enable subsequent reshaping of the patient's nasal passage, for example, reshaping facilitated by softening caused by the delivery of ultrasonic energy to the tissue by EDD100 or by other treatments. In some embodiments, the reshaping of the patient's nasal passage is performed via a catheter device including a balloon configured to apply reshaping force to the patient's nasal passage.

[0227] It should be understood that the embodiments described above are illustrative only, and further embodiments are conceivable. Any feature described herein in relation to any one embodiment may be used alone or in combination with other features described, or in combination with one or more features of any other embodiment, or any combination of any other embodiment. Furthermore, equivalents and variations not described above may also be used, without departing from the scope of the invention as defined in the appended claims.

Claims

1. A system for performing medical procedures on patients, By delivering ultrasonic energy to generate image data, It includes an array of ultrasonic transducers configured to deliver focused ultrasonic energy to excise multiple target tissue locations, The aforementioned multiple target tissue locations are arranged within a tissue volume having a heterogeneous structure. The image data includes data related to the multiple target tissue locations and data related to one or more non-target tissue locations. The system is configured to distinguish between target tissue locations and non-target tissue locations based on the image data. The system is further configured to avoid delivering the focused ultrasonic energy to non-target tissue locations based on the image data, A system wherein the array of ultrasonic transducers is further configured to deliver marking energy, including ultrasonic energy configured to induce a detectable change in tissue.

2. The system according to claim 1, wherein the plurality of target tissue locations include locations within the tongue, tonsils, and / or other airway locations.

3. The system according to claim 1 or 2, wherein the focused ultrasonic energy includes high-density focused ultrasound (HIFU) energy.

4. The system according to claim 3, wherein the HIFU energy is delivered at a frequency between 5 MHz and 10 MHz.

5. The system according to claim 1 or 2, wherein each of the plurality of target tissue locations includes tissue with a volume having a length of less than 0.5 mm and a width of less than 3.0 mm.

6. The system according to claim 1 or 2, wherein the system is configured to avoid the formation of scabs.

7. The system according to claim 6, wherein each of the plurality of target tissue locations includes a subsurface tissue location, and one or more non-target tissue locations include a surface tissue location.

8. The system according to claim 1 or 2, wherein one or more non-target tissue locations include a blood conduit.

9. The system according to claim 1 or 2, further comprising spacer elements configured to be positioned between the array of ultrasonic transducers and tissue surfaces adjacent to the plurality of target tissue locations.

10. The system according to claim 9, wherein the spacer element includes a fluid-containing structure, and the fluid-containing structure is configured to expand and / or contract when fluid is added and / or removed.

11. The system according to claim 1 or 2, further configured to identify and / or track excised and unexcised tissue based on the image data.

12. The system according to claim 1, wherein the focused ultrasonic energy has a first set of energy delivery settings, and the marking energy has a second set of energy delivery settings, wherein the first set of energy delivery settings is different from the second set of energy delivery settings.

13. The system according to claim 1, further configured to mark tissue by delivering the marking energy in a specific pattern and to identify the specific pattern based on the image data.

14. The system according to claim 1 or 2, wherein the focused ultrasonic energy is delivered to the plurality of target tissue locations in a discontinuous manner.

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