Tissue Treatment System

Abstract

A system for administering a medical procedure to a patient is provided. The system includes at least one of an energy delivery apparatus, a long-term energy delivery device, and / or a force supply apparatus. In particular, the system may be configured to treat and / or diagnose a patient 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 No. USD-004-PR1), entitled "Tissue Interface System," filed June 1, 2021, the contents of which are incorporated by reference in their entirety herein for all purposes.

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 286,161 (Docket No. USD-008-PR1), entitled “Capacitive Micromachined Ultrasonic Transducer,” filed on December 6, 2021, the contents of which are incorporated by reference in their entirety herein for all purposes.

[0003] This application is related to U.S. Provisional Patent Application No. 62 / 728,616, entitled “Medical Device with CMUT Array and Solid State Cooling, and Associated Methods and Systems-with Thermal Analysis,” filed September 7, 2018 (Docket No. USD-001-PR), the contents of which are incorporated by reference in their entirety for all purposes.

[0004] This application is related to U.S. Application No. 16 / 130,896 (Docket No. USD-001-US), filed September 13, 2018, entitled “Medical Device with CMUT Array and Solid State Cooling, and Associated Methods and Systems,” and U.S. Patent No. 11,154,730, issued October 26, 2021, the contents of which are incorporated by reference in their entirety for all purposes.

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

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

[0007] This application is related to U.S. Provisional Patent Application No. 63 / 126,078 (Docket No. USD-003-PR1), entitled "Tissue Interface System," filed on December 16, 2020, the contents of which are incorporated by reference in their entirety into this specification for all purposes.

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

[0009] Technical Field FIELD OF THE DISCLOSURE The embodiments disclosed herein relate generally to systems for performing medical procedures on a patient, and more particularly to systems for delivering ultrasound energy to perform diagnostic and / or therapeutic procedures on tissue of a patient. [Background technology]

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

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

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

[0015] In some embodiments, the system is configured to diagnose and / or treat a patient suffering from sleep apnea. The system may include two or more of an energy delivery device, a long-term energy delivery device, and / or a force supply device.

[0016] In some embodiments, the system is configured to ablate target tissue of the patient and avoid damaging non-target tissue of the patient.

[0017] In some embodiments, the system includes an ultrasonic transducer array having one, two, or more ultrasonic transducers. The ultrasonic transducer array 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 identify target tissue for ablation by the system. The algorithm may be configured to distinguish between target tissue and non-target tissue.

[0019] The technology described herein, together with its attributes and attendant advantages, will best be appreciated and understood by considering the following detailed description in conjunction with the accompanying drawings, in which representative embodiments are illustrated by way of example.

[0020] Incorporation by Reference All publications, patents, and patent applications mentioned in this specification are incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. [Brief description of the drawings]

[0021] [Figure 1] 1 illustrates a system for treating and / or diagnosing tissue consistent with the concepts of the present invention. [Diagram 2] 1 is a flow chart of a method of providing therapy in a closed loop configuration consistent with the concepts of the present invention. [Diagram 3]1 is a flow chart of a method for treating a patient consistent with the concepts of the present invention. [Figure 4] 1 shows a side cross-sectional anatomical view of a chronic energy delivery device implanted in a patient for nerve stimulation consistent with the concepts of the present invention. [Diagram 5] 1 shows a side cross-sectional anatomical view of a chronic energy delivery device implanted in a patient for nerve stimulation consistent with the concepts of the present invention. [Figure 6A] 1 shows a side cross-sectional anatomical view of a force delivery device implanted in a patient to apply force to tissue, consistent with the concepts of the present invention. [Figure 6B] 1 shows a side cross-sectional anatomical view of a force delivery device implanted in a patient to apply force to tissue, consistent with the concepts of the present invention. [Figure 7] 1 shows a partially transparent anatomical view of a force delivery device implanted in a patient to apply force to tissue consistent with the concepts of the present invention. [Figure 8] 1 shows a cross-sectional anatomical view of an energy delivery device for delivering energy to tissue consistent with the concepts of the present invention. [Figure 9] 1 shows a side view of an energy delivery device delivering energy to tissue captured by the device, consistent with the concepts of the present invention. [Figure 10] 1 shows a perspective view of an energy delivery device delivering energy to tissue captured by the device consistent with the concepts of the present invention. [Figure 11] 1 shows a perspective view of an energy delivery device delivering energy to tissue captured by the device consistent with the concepts of the present invention. [Figure 12] 1 illustrates a side cross-sectional anatomical view of an energy delivery device positioned on the skin under a patient's chin and delivering energy to tongue tissue, consistent with the concepts of the present invention. [Figure 13] 1 illustrates a side cross-sectional anatomical view of an energy delivery device being advanced transnasally to position a transducer within a patient's airway consistent with the concepts of the present invention. [Figure 14] 1 illustrates a frontal anatomical view of an energy delivery device positioned on a patient's face consistent with the concepts of the present invention. [Figure 15]1 shows a perspective view of a system including an energy delivery device with a shaft and a transducer disposed distally and having a diameter close to that of the shaft, consistent with the concepts of the present invention. [Figure 16] 1 shows a perspective view of a system including an energy delivery device with a shaft and a transducer disposed distally and having a diameter larger than the diameter of the shaft, consistent with the concepts of the present invention. [Figure 17] 1 illustrates a side cross-sectional anatomical view of an energy delivery device including an energy delivery module and a mirror, consistent with the concepts of the present invention. [Figure 18A] 1 shows a top view of an energy delivery device consistent with the concepts of the present invention. [Figure 18B] 1 shows a side cross-sectional anatomical view of an energy delivery device consistent with the concepts of the present invention. [Figure 19] 1 shows a side cross-sectional anatomical view of an energy delivery device inserted transnasally into a patient consistent with the concepts of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] Reference will now be made in detail to the present embodiments of the present technology, examples of which are illustrated in the accompanying drawings. Like reference numerals are used to refer to like elements. However, this description is not intended to limit the disclosure to the particular embodiments, but should be construed as including various modifications, equivalents, and / or alternatives to the embodiments described herein.

[0023] It will be understood that certain features of the invention, which are for clarity described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are for brevity described in the context of a single embodiment, may also be provided separately or in any suitable subcombination. For example, it will be understood that all features recited in any claim (whether independent or dependent) may be combined in any given manner.

[0024] At least some of the drawings and descriptions of the present invention have been simplified to focus on elements relevant for a clear understanding of the present invention, but it should be understood that for the sake of clarity, the omission of other elements that one of ordinary skill in the art would understand may also be part of the present invention. However, because such elements are well known in the art and because they do not necessarily facilitate an understanding of the invention, descriptions of such elements are not provided herein.

[0025] The terms defined in this disclosure are used only to describe certain 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 the context clearly indicates otherwise. All terms used herein, including technical or scientific terms, have the same meaning as commonly understood by those skilled in the relevant field, unless otherwise defined herein. Terms defined in commonly used dictionaries should be interpreted as having the same or similar meaning as the meaning in the context of the relevant technology, and should not be interpreted as having an ideal or exaggerated meaning unless explicitly defined herein. In some cases, the terms defined in this disclosure should not be interpreted as excluding embodiments of the disclosure.

[0026] As 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") should be understood to specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0027] It will be further understood that, although terms such as first, second, third, etc. may be used herein to describe various limits, elements, components, regions, layers, and / or sections, these limits, elements, components, regions, layers, and / or sections should not be limited by these terms. These terms are used only to distinguish one limit, element, component, region, layer, or section from another limit, element, component, region, layer, or section. Thus, a first limit, element, component, region, layer, or section described below may be referred to as a second limit, element, component, region, layer, or section without departing from the disclosure of this application.

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

[0029] It will be further understood that when a first element is referred to as being "in," "on," and / or "within" a second element, the first element may be disposed within an interior space of the second element, within a portion of the second element (e.g., within a wall of the second element), disposed on an exterior and / or interior surface of the second element, and combinations of two or more of these.

[0030] As used herein, the term "proximate," when used to describe the proximity of a first component or location to a second component or location, should be interpreted to include one or more locations near the second component or location, as well as in, on, and / or within the second component or location. For example, a component that is positioned proximate to an anatomical site (e.g., a target tissue location) is intended to include a component that is positioned near the anatomical site, as well as a component that is positioned in, on, and / or within the anatomical site.

[0031] Spatially relative terms, such as "below," "lower," "bottom," "upper," "top," may be used to describe the relationship of an element and / or feature to another element(s) and / or feature(s), for example, as shown in the drawings. It will be further understood that the spatially 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 drawings is turned over, elements described as "below" and / or "below" the other elements or features may then be oriented "above" the other elements or features. The device may be otherwise oriented (e.g., rotated 90 degrees, or to other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0032] As used herein, the terms "reduce," "reducing," "reduction," and the like are intended to include a reduction in amount, including a reduction to zero. Reducing the likelihood of occurrence is intended to include prevention of occurrence. Similarly, as used herein, the terms "prevent," "preventing," "prevention," and the like are intended to include the acts of "reduce," "reducing," and "reducing," respectively.

[0033] The term "and / or" as used herein should be construed as a specific disclosure of each of the two specified features or components, regardless of the presence or absence of the other. For example, "A and / or B" should be construed as a specific disclosure of (i) A, (ii) B, and (iii) each of A and B, as if each were individually set forth herein.

[0034] As used herein, the term "one or more" can mean 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more, up to any number.

[0035] The terms "and combinations thereof" and "and combinations thereof," respectively, may be used herein following a list of items that are included singly or collectively. For example, components, processes, and / or other items selected from the group consisting of A, B, C, and combinations thereof, shall include a set of one or more components that includes 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] As used herein, unless otherwise stated, "and" can mean "or" and vice versa. For example, if a feature is described as having A, B, or C, the feature can 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, the feature can have only one or two of A, B, or C.

[0037] As used in this disclosure, the phrase "configured for" may be used interchangeably with, for example, "suitable for," "capable of," "designed for," "adapted for," "made for," and "capable of," depending on the context. The phrase "configured for" does not only mean "specially designed for" in hardware. Alternatively, depending on the context, the phrase "apparatus configured for" may mean that an apparatus is "capable of" operating in conjunction with another apparatus or component.

[0038] As used herein, the term "threshold" refers to a maximum level, a minimum level, and / or a range of values ​​that correlate to a desired or undesirable state. In some embodiments, a system parameter is maintained above a minimum threshold, below a maximum threshold, within a threshold range of values, and / or outside a threshold range of values, e.g., to provide a desired effect (e.g., effective treatment) and / or prevent or otherwise reduce (hereinafter "prevent") an undesirable event (e.g., adverse device and / or clinical events). In some embodiments, a system parameter is maintained above a first threshold (e.g., above a first temperature threshold to provide 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, the thresholds are determined to include a safety margin, e.g., taking into account patient variability, system variability, tolerances, 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, "room pressure" is intended to mean the pressure of the environment surrounding the systems and devices of the inventive concept. "Positive pressure" includes pressure above room pressure, or simply a pressure greater than another pressure, such as a positive pressure differential across a fluid path component such as a valve. "Negative pressure" includes pressure below room pressure, or a pressure less than another pressure, such as a negative pressure differential across a fluid path component such as a valve. Negative pressure may include a vacuum, but does not mean a pressure less than a vacuum. As used herein, the term "vacuum" may be used to refer to a full vacuum or 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 an imaginary circle that approximates the geometric shape being described. For example, when describing a cross-section, such as a cross-section of a component, the term "diameter" is interpreted as representing the diameter of an imaginary 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 are the length and diameter, respectively, of an imaginary cylinder of smallest volume that could completely enclose the component.

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

[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 construed to include any component or combination of components that receives energy or any input and generates an output. For example, a transducer may include an electrode that receives electrical energy and distributes the electrical energy to tissue (e.g., based on the size of the electrode). In some configurations, a transducer converts an electrical signal into any output, such as light (such as a transducer including a light emitting diode or a light bulb), sound (such as a transducer including one or more piezoelectric transducers and / or a CMUT transducer configured to deliver and / or receive ultrasonic energy), pressure (such as an applied pressure or force), thermal energy, cryogenic energy, chemical energy, mechanical energy (such as a transducer including a motor or a 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 (such as a change in a physical quantity) into an electrical signal. A transducer may include any component that delivers energy and / or an agent to tissue, such as a transducer configured to deliver thermal energy to tissue, cryogenic energy to tissue, electrical energy to tissue (such as a transducer including one or more electrodes), optical energy to tissue (such as a transducer including a laser, a light emitting diode, and / or an optical component such as a lens or prism), mechanical energy to tissue (such as a transducer including a tissue manipulation element), acoustic energy to tissue (such as a transducer including one or more piezoelectric and / or CMUT transducers), chemical energy, electromagnetic energy, magnetic energy, and combinations of two or more thereof. Alternatively or additionally, a transducer may include a mechanism, such as a valve, a grasping element, a fixation mechanism, an electrically actuated mechanism, a mechanically actuated mechanism, and / or a thermally activated mechanism.

[0045] As used herein, the term "functional element" should be interpreted to include 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 (such as 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, such as patient physiological parameters, patient anatomical parameters (such as tissue parameters), patient environmental parameters, and / or system parameters (such as temperature and / or pressure within the system). In some embodiments, a sensor or other functional element is configured to perform a diagnostic function (e.g., collect data used to perform a diagnosis). In some embodiments, a functional element is configured to perform a therapeutic function (e.g., deliver therapeutic energy and / or a therapeutic agent). In some embodiments, the functional element includes one or more elements constructed and arranged to perform a function selected from the group consisting of: delivering energy, extracting energy (e.g., to cool a component), delivering a drug or other agent, manipulating a system component or patient tissue, recording or sensing a parameter, such as a patient physiological parameter or a patient anatomical parameter, and combinations of two or more thereof. A "functional assembly" may include an assembly constructed and arranged to perform a function as described above. In some embodiments, the functional assembly is configured to deliver energy and / or treat tissue (such as a functional assembly configured as a treatment assembly). Alternatively or additionally, the functional assembly may be configured to record one or more parameters, such as a patient physiological parameter, a patient anatomical parameter, a patient environmental parameter, and / or a system parameter. The functional assembly may include an expandable assembly. The functional assembly may include one or more functional elements.

[0046] As used herein, the term "active agent" is intended to include, but is not limited to, one or more active agents selected from the group consisting of 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 tissue in a patient to be diagnosed and / or treated. Similarly, a "treatment target" or "tissue target" includes one or more volumes of tissue to be diagnosed and / or treated. A "safety margin tissue" includes tissue whose treatment (e.g., receiving ablative energy) will not result in significant adverse effects to the patient. A "non-target tissue" includes tissue that is not intended to receive treatment (e.g., not intended to receive energy). In some embodiments, a "target tissue," "treatment target," and / or "tissue target" includes non-tissue material, e.g., pigment particles used in tattoos, debris such as wood or metal pieces, and / or other undesirable material present in the patient's body.

[0048] As used herein, the term "system parameters" includes one or more parameters of the system of the inventive concept. The system parameters may include one or more "energy delivery parameters" (also referred to as "energy delivery settings"), such as one, two, or more energy delivery parameters selected from the group consisting of energy form (e.g., ultrasound, light, electromagnetic, etc.), amplitude, frequency, waveform shape, pulse width modulation parameters, time division multiplexing parameters, pulse width, pulse rate, duty cycle, area of ​​the energy beam (e.g., ultrasound beam and / or light beam), location of energy delivery, tissue temperature, such as the starting temperature of the tissue before treatment, other energy delivery parameters, and combinations thereof. The system parameters may include parameters selected from the group consisting of energy delivery parameters, pressure levels, temperature levels, energy levels, frequency levels, amplitude levels, battery levels, and combinations thereof. The system parameters may include one or more tissue targets identified for treatment (e.g., tissue volumes intended to be ablated and / or stimulated), such as tissue targets identified for treatment by the algorithms of the system.

[0049] As used herein, the term "patient parameters" includes one or more parameters associated with a patient. The patient parameters may include patient physiological parameters, such as physiological parameters selected from the group consisting of temperature (such as tissue temperature), pressure, such as blood pressure or other body fluid pressure, pH, blood gas parameters, blood glucose levels, hormone levels, heart rate, respiratory rate, and combinations thereof. Alternatively or additionally, the patient parameters may include patient environmental parameters, such as environmental parameters selected from the group consisting of the patient's geographic location, temperature, pressure, humidity level, light level, time of day, and combinations thereof.

[0050] As used herein, the term "image data" includes data generated by one or more imaging devices. Image data may include data related to target tissue, safety margin tissue, and non-target tissue. Image data may also include data related to any implants or other non-tissue objects proximate the tissue being imaged. Image data may be processed by one or more algorithms of the inventive concepts to, for example, determine one or more locations to treat (e.g., target tissue identified to be ablated or receive energy) and / or determine one or more locations to avoid energy delivery (e.g., non-target tissue). 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 are intended to refer to the transmission of power and / or data in any direction between two or more components.

[0052] As used herein, the term "patient usage data" refers to data relating to the use of a tissue interface system of the present concepts with a patient (e.g., the use of the system in a diagnostic and / or therapeutic procedure performed on a patient). The data may include, but is not limited to, energy delivery parameters, operational parameters such as duration of energy delivery, target tissue parameters such as target tissue location and / or target tissue volume, patient parameters such as patient physiological parameters and / or patient location or other patient environmental parameters, clinician parameters, clinical site parameters, and combinations thereof. Patient usage data may include data from multiple patients, e.g., data collected from multiple patients interfaced with one or more systems of the present concepts. In some embodiments, algorithms of the present concepts use patient usage data from one or more patients to determine system parameters to be used in performing a medical procedure on a patient.

[0053] As used herein, the term "conduit" or "conduit(s)" can refer to an elongated component that may include one or more flexible and / or inflexible filaments selected from the group consisting of one, two or more wires or other electrical conductors (e.g., including outer insulation), one or more waveguides, one, two or more hollow tubes, such as hydraulic, pneumatic, and / or other fluid delivery tubes, one or more optical fibers, one, two or more control cables and / or other mechanical links, one, two or more flex circuits, and combinations thereof. A conduit can include a tube that includes multiple conduits disposed within the tube. A conduit can be configured to electrically, fluidically, acoustically, optically, mechanically, and / or otherwise operatively connect one component to another.

[0054] As used herein, a component shall be considered an "implantable" component or a component "implanted" in a patient if it is disposed anywhere beneath the patient's skin (e.g., within the patient's tissue, within and / or at the patient's airway, as well as other internal locations). An implantable device may be implanted in a patient via a surgical procedure (e.g., a procedure in which an incision is made in the patient's skin) and / or the device may be implanted via delivery through a natural orifice (such as the mouth, eyes, nostrils, ear canal, anal opening, urethral opening, vagina, and / or skin pores).

[0055] As used herein, an "ultrasonic transducer" (also referred to as an "ultrasonic element") may refer to one or more components configured to transmit ultrasonic energy (e.g., based on a delivered electrical signal) and / or one or more components configured to receive ultrasonic energy (and, e.g., convert it into an electrical signal). An ultrasonic transducer may include a set of one or more ultrasonic transducers, e.g., a 1D or 2D array of ultrasonic transducers. An ultrasonic transducer may refer to a set of one or more piezoelectric transducers (also referred to as "piezo" transducers or elements), a set of one or more capacitive micromachined ultrasonic transducers (CMUT), or one or more sets of both.

[0056] As used herein, an "optical transducer" (also referred to as an "optical element") may refer to 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 passage of light (e.g., a lens, a prism, an optical fiber, etc.).

[0057] The systems of the present concepts 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. The energy delivery modules of the present concepts may include modules configured to deliver and / or receive various forms of energy, such as ultrasonic energy. In some embodiments, one, two, or more arrays of piezoelectric transducers and / or one, two, or more arrays of CMUTs are included to deliver ultrasonic energy (e.g., to stimulate, ablate, and / or affect tissue) and / or receive reflections of ultrasonic energy (e.g., to image tissue, such as when the same and / or different elements deliver reflected and received energy).

[0058] Referring now to FIG. 1, a schematic diagram of a tissue interface system consistent with the concepts of the present invention is shown. The system 10 may be configured to perform a medical procedure on a patient. The medical procedure performed using the system 10 may include performing one or more clinical procedures (also referred to herein as "medical procedures"), such as one or more diagnostic procedures and / or one or more therapeutic procedures performed on a patient. The system 10 may be configured to diagnose and / or treat one or more medical conditions (such as diseases and / or disorders) of the patient. The system 10 may be configured to treat and / or diagnose one or more portions (e.g., volumes) of the patient tissue, herein "target tissue." In some embodiments, the system 10 includes one or more devices configured to deliver one or more forms of energy to the target tissue, e.g., to stimulate, condition, ablate, and / or otherwise treat the target tissue. Alternatively or additionally, the system 10 may include one or more devices configured to generate image data, image data ID, which may include image data of the tissue and / or one or more objects proximate the tissue. The image data ID may include tissue or other object image data used in determining a diagnosis and / or prognosis (either or both are referred to herein as "diagnosis"). Alternatively or additionally, the image data ID may include tissue or other object image data used in a tissue treatment procedure (e.g., to guide or otherwise affect stimulation, ablation, and / or other tissue treatment procedure). The image data ID may include image data related to target tissue, safety margin tissue, non-target tissue, implantable diagnostic and / or therapeutic devices, foreign bodies (e.g., debris, tattoos, etc.), and combinations thereof. The system 10 may be configured to generate the image data ID through delivery of energy, e.g., delivered sound energy and / or light energy, and collect reflections thereof to generate the image data ID, as described herein. In some embodiments, the image data ID includes data related to tissue containing blood, e.g., where the image data ID includes 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, the terms "tissue diagnostic procedure," "tissue diagnosis," and derivatives thereof include, but are not limited to, the delivery of energy to collect image data ID (e.g., when system 10 records the reflection of the delivered ultrasound, light, or other energy and converts these records into image data ID), the delivery of energy to tissue to characterize the tissue (e.g., when system 10 records one or more effects on the tissue from the energy delivery, such as using spectroscopy), and / or the recording of one or more tissue properties using one or more sensors of system 10. In some embodiments, the tissue diagnosis performed by system 10 includes a diagnosis of the tissue, such as a diagnosis that evaluates the level of tissue ablation (e.g., the 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 within a 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 evaluate the level of tissue ablation).

[0060] As used herein, "tissue treatment procedure," "tissue therapy," and derivatives thereof include, but are not limited to, ablation of tissue, removal of tissue, causing necrosis of tissue, reducing the volume of tissue (e.g., debulking of tissue), stimulation of tissue, increasing the strength of tissue (e.g., muscle tissue), scaffolding of tissue and / or airways, manipulating and / or otherwise applying force to tissue, hardening of tissue, and / or otherwise causing a therapeutic effect on tissue. As used herein, "tissue reduction procedure" or "tissue reduction," and derivatives thereof, include tissue treatment procedures that reduce the volume of a portion of tissue (e.g., a target tissue), including, for example, ablation of tissue, lithotripsy of tissue, histotripsy of tissue, removal of tissue, liquefaction of tissue (e.g., liquefaction of adipose tissue), causing necrosis of tissue, debulking of tissue, and / or otherwise causing a reduction in the volume of tissue (e.g., reduction within one day, one week, and / or one month of treatment). In some embodiments, tissue reduction procedures include procedures that alter tissue (e.g., alter the geometry of the tissue volume), e.g., to reduce 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 derivatives thereof include tissue treatment procedures in which a portion of tissue (such as muscle tissue or other tissue) is augmented, hardened, tightened, toned, moved (e.g., to a better position), and / or otherwise augmented, such as augmentation used to reduce one or more deleterious effects of a patient's disease or disorder (such as sleep apnea) and / or augmentation used for cosmetic procedures (e.g., to reduce wrinkles and / or improve the patient's aesthetics). Tissue augmentation procedures may include delivery of energy (such as ultrasound energy) to perform neuromodulation. Tissue augmentation procedures may include delivery of energy (such as ultrasound energy) configured to ablate specific tissue (such as tongue tissue) to augment adjacent muscle tissue (e.g., to augment tongue muscle tissue).

[0061] As used herein, a "treatment plan" includes a set of parameters to be used in treating a target tissue of a patient with the system 10. The treatment plan may include a set of energy delivery settings, e.g., levels or forms of energy delivery, locations of energy delivery, and / or other energy delivery parameters defined herein. The treatment plan may include a set of different medical procedures (e.g., one or more various medical procedures, such as tissue reduction procedures, tissue augmentation procedures, tissue force delivery procedures, drug therapy, CPAP therapy, and / or other procedures). The treatment plan may include a desired and / or recommended order for performing a set of multiple medical procedures (e.g., when a treatment plan provides for multiple procedures to be performed in a particular order, in some instances, sufficient efficacy is achieved when a subset of the medical procedures is performed). In some embodiments, the system 10 is configured to automatically and / or semi-automatically (herein "automatically") generate a treatment plan (e.g., one or more treatment plans available to a clinician). The system 10 may generate a treatment plan using an algorithm, such as the algorithm 50 described herein. The treatment plan may be developed by the algorithm 50 using at least the image data ID, for example, by using image data ID 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-ray). Alternatively or additionally, the algorithm 50 may develop a proposed treatment plan based on parameters selected from the following group: patient age, volume of target tissue to be resected, reduced in volume, and / or otherwise treated (e.g., where the target tissue includes tumor tissue, adenoid tissue, tongue tissue, tonsil tissue, and / or other tissue), fat content of the target tissue, geometry of the target tissue, tissue type, geometry, and / or other characteristics of non-target tissue adjacent to the target tissue, geometry of airways 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 (e.g., via the algorithm 50) is configured to generate a prediction of an outcome (e.g., an estimate of the likelihood of efficacy and / or an assessment of risk) associated with one or more treatment plans. For example, the algorithm 50 may be configured to analyze data from a population of patients, such as patients with similar tissue configurations (e.g., similar tissue geometries associated with impact on sleep apnea events).

[0062] System 10 may include an EDD 100, which includes one, two, or more energy delivery devices that are used by a doctor, nurse, and / or medical technician (herein a "clinician") to diagnose and / or treat a patient via the delivery of energy in a medical procedure. System 10 may include multiple energy delivery devices, such as the illustrated EDDs 100, 100', and / or 100" (generally EDD 100). During its medical use (such as diagnostic and / or therapeutic use), one or more energy delivery portions of the EDD 100 are placed at one or more locations on the patient or at a location proximate to the patient, herein at location L100, and target tissue proximate to location L100 may be diagnosed and / or treated by the EDD 100 via delivery of one or more forms of energy as described herein. In some embodiments, the EDD 100 is configured to receive one or more forms of energy, e.g., reflected energy used to generate image data ID, and / or energy representing control signals or other data transmitted (e.g., wirelessly transmitted) to the EDD 100. The EDD 100 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 controller. In some embodiments, the EDD 100 includes multiple individual components. The EDD 100 includes one or more housings, illustrated as housing 101, e.g., one or more housings enclose one or more components of the EDD 100.

[0063] The system 10 may include a CEDD 200, which may include one, two or more Chromic Energy Delivery Devices, that may be implanted, placed, and / or provided to a patient to perform diagnosis and / or treatment of the patient on an ongoing basis (e.g., for a period of at least one week, at least one month, at least three months, and / or at least six months). System 10 may include multiple chronic energy delivery devices, such as the illustrated CEDD 200, 200', and / or 200" (generally CEDD 200). During medical use, one or more energy delivery portions of CEDD 200 are placed in one or more locations, here location L200, within, on, and / or proximate to a patient, such that target tissue proximate location L200 may be diagnosed and / or treated by CEDD 200 via delivery of one or more forms of energy, as described herein. Energy may be delivered relatively continuously and / or intermittently by CEDD 200, also as described herein. In some embodiments, CEDD 200 is configured to receive one or more forms of energy, for example reflected energy used to generate image data ID, or energy representing control signals and / or other data transmitted (e.g., wirelessly transmitted) to CEDD 200. CEDD 200 includes one or more housings, shown as housing 201, e.g., one or more housings enclose one or more components of CEDD 200.

[0064] The CEDD 200 may include one or more separate components, for example, one or more components that are positioned external to but proximate to the patient's skin during use, and / or one or more components that are implanted within the patient (e.g., within the airway). In some embodiments, the CEDD 200 includes a first component that includes the EDM 250 to deliver energy to tissue (e.g., to perform an imaging procedure and / or a therapeutic treatment), and a second component configured to provide power to the first component, for example, via a wired or wireless connection. For example, the CEDD 200 may include a first component that is implanted within the patient and a second component that is positioned (during use) on the patient's skin proximate to the implantation location of the first component (e.g., as described herein with reference to FIG. 4). In some embodiments, the CEDD 200 may include a first component implanted in the patient, the first component comprising the EDM 250 and configured to deliver energy to tissue (e.g., to perform an imaging procedure and / or a therapeutic treatment), and a second component also implanted in the patient and configured to provide power to the first component, e.g., via a wired or wireless connection (e.g., as described with reference to FIG. 5 herein). In these embodiments, the CEDD 200 may include a third component disposed outside the patient's body, e.g., the third component provides power to the first component and / or the second component (e.g., via wireless energy transfer). CEDD200 includes components arranged as a flexible sheet and / or tubular structure that can be wrapped around and / or positioned along the nerve, such as 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 (such as from a second component of CEDD200), convert the ultrasonic energy into electrical energy that is delivered to tissue (e.g., via one or more electrodes as described herein with reference to Figures 4-5).In these embodiments, the array of ultrasonic transducers that receive the ultrasonic energy may be configured as a relatively omnidirectional assembly such that ultrasonic energy may be successfully delivered from multiple locations (e.g., sensitivity to the location of the component delivering the ultrasonic energy is greatly reduced).

[0065] In some embodiments, the CEDD 200 is configured to deliver energy (such as ultrasound energy) via the EDM 250 and collect image data ID associated with a target tissue that also receives energy (such as stimulation energy) from the EDM 250. The energy delivered by the EDM 250 to generate the image data ID (e.g., via reflection of the delivered energy received by the EDM 250) and the stimulation energy delivered by the EDM 250 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 (e.g., the EDM 250 switches continuously between an imaging mode and a stimulation mode) based on the collected image data ID. This closed-loop configuration can increase the effectiveness of the stimulation, e.g., when stimulating airway tissue to treat sleep apnea, adjustments in the trajectory of the stimulation energy delivery are made when the patient moves during sleep. In some embodiments, a first portion of the EDM 250 generates at least image data ID (e.g., and optionally delivers stimulation energy) and a second portion of the EDM 250 delivers at least stimulation energy (e.g., and optionally collects image data ID). In some embodiments, the first and second portions of the EDM 250 deliver stimulation energy to at least the same target tissue (so that, for example, the total amount of stimulation energy delivered to the target tissue exceeds the maximum amount delivered by any portion of the EDM 250).

[0066] System 10 can include a FAD 300, which can include one, two or more force-applying devices that are implanted, positioned, and / or provided to a patient to apply one or more forces to a target tissue of the patient (e.g., forces applied to the tissue relatively continuously and / or intermittently over a period of at least one week, at least one month, at least three months, and / or at least six months). System 10 may include multiple force-delivery devices, such as the illustrated FADs 300, 300', and / or 300" (generally FAD 300). During medical application, one or more force-delivery portions of FAD 300 are positioned at one or more locations, here location L300, within, on, and / or near a patient, such that target tissue proximate location L300 can receive a force applied by FAD 300. FAD 300 can be used to apply a force to patient tissue (e.g., muscle tissue) to produce a therapeutic effect on the tissue (e.g., to cause continuous and / or intermittent movement of muscle tissue, such as to strengthen the muscle). Alternatively or additionally, FAD 300 can apply a force to patient tissue to compress and / or ameliorate the tissue. or scaffolding (e.g., scaffolding an airway), for example, to increase the opening (e.g., cross-sectional area) of the airway (e.g., to push tissue out of the patient's airway and treat sleep apnea). In some embodiments, the FAD 300 is configured to apply a force to tissue in a passageway (e.g., a blood vessel, a conduit, a tissue tract, and / or a valve), for example, to close the passageway (e.g., to close a valve). The FAD 300 may include one or more portions that attach to tissue (e.g., attach to bone or other tissue), as described with reference to Figures 6A-6B and / or 7 herein. The FAD 300 may include an arch-like structure (e.g., including two actuator portions), as described with reference to Figure 7 herein.

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

[0068] In some embodiments, the console 500 includes one, two, or more energy delivery assemblies, e.g., the controller 510 includes one, two, or more energy delivery assemblies. In these embodiments, the controller 510 may include an assembly configured to deliver one or more forms of energy, e.g., energy selected from the group consisting of ultrasound energy, radio frequency and / or other electromagnetic energy, light 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 provide light to the EDD 100, the CEDD 200, the FAD 300, and / or another component of the system 10. The light source may be configured to perform an imaging procedure (such as OCT or other light-based imaging procedure) and / or a tissue elastography analysis. In some embodiments, functional element 599 includes a light source, which is configured to deliver light to tissue and / or to deliver light to an agent to affect the tissue and / or the agent (e.g., to stimulate the tissue and / or activate the agent, respectively). In some embodiments, controller 510 includes one or more algorithms, such as algorithm 50 described below. In these embodiments, energy delivery and / or other functions provided by controller 510 and / or other components of console 500 may be controlled by the algorithm.

[0069] System 10 may include the illustrated algorithm 50, which may include one or more algorithms. All or a portion of algorithm 50 may be integrated into one, two or more of the various components of system 10, such as EDD 100, CEDD 200, FAD 300, and / or console 500. Algorithm 50 may include one or more machine learning, neural network, and / or other artificial intelligence algorithms (herein "AI algorithms").

[0070] Algorithm 50 can be configured to determine and / or modify one or more energy delivery parameters defined herein, for example, to effectively treat (e.g., ablate) targeted tissue while avoiding damage to non-targeted tissue.

[0071] In some embodiments, the algorithm 50 (e.g., an AI algorithm) may be configured to determine a volume of the target tissue to be treated and to effectively provide a therapeutic effect to the patient while avoiding or at least minimizing damage to non-target tissue. In these embodiments, the algorithm 50 may be further configured to determine and / or modify one or more energy delivery parameters (e.g., based at least on the determined volume) to, e.g., 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 ablation 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] The algorithm 50 may be configured to perform a tissue classification analysis, including a "tissue ablation analysis" that includes the use of one or more types of information analyzed by the algorithm 50 to assess the level of ablation (e.g., current ablation level) of the target tissue (e.g., ultrasound or MRI-based elastography analysis to distinguish between living and dead tissue and / or ablated and non-ablated tissue). The results of this analysis may be used by the system 10 to deliver energy in a closed-loop mode as described herein. The tissue ablation data generated in the tissue ablation analysis may be stored as image data ID (e.g., in association with one or more tissue locations). In some embodiments, the system 10 delivers and / or receives energy (e.g., ultrasound energy) to and / or from the tissue, and the 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 geometry of a volume of tissue) of the ablated (e.g., ablated sufficiently to provide the patient with the intended benefit).

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

[0075] The algorithm 50 may be configured to adjust energy delivery parameters based on the sensor signal, for example, where the sleep sensor signal is used to modify the delivery of energy to a sleep apnea patient while sleeping (such as to optimize therapy provided to the sleep apnea patient). Adjustments in energy delivery may occur during delivery of ablation energy and / or during delivery of stimulation energy.

[0076] In some embodiments, algorithm 50 is configured to verify that signals generated by sensors of system 10, as described herein, are associated with a patient being treated by system 10. For example, algorithm 50 may be configured to identify, differentiate, 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, pets, or other people in the same room as the patient while the patient is sleeping).

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

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

[0079] In some embodiments, system 10 collects image data ID (e.g., using ultrasound as described herein) and algorithm 50 analyzes the collected image data ID to generate a treatment plan (e.g., as described herein), including one or more treatment plans that are provided to a clinician as suggestions for treating the patient for whom the image data ID was collected. In these embodiments, algorithm 50 may generate the treatment plan based on additional data, such as data related to any physiological, genetic, and / or other patient information.

[0080] Each of the EDD 100, CEDD 200, and / or FAD 300 (singly or collectively herein "devices 100 / 200 / 300") may include a control module, controller 110, 210, and / or 310, respectively, as shown. Each of the controllers 110, 210, and / or 310 (singly or collectively controllers 110 / 210 / 310) may include one or more central processing units (CPUs), microprocessors, and / or other microcontrollers, memory (such as volatile or non-volatile memory), signal processing and other electronic circuitry, analog-to-digital circuitry, digital-to-analog circuitry, and / or other components configured to control or interface with one or more components of the system 10, such as the EDD 100, CEDD 200, and / or FAD 300, respectively. The controller 110 / 210 / 310 may include one or more electronic elements, electronic assemblies, and / or other electronic components, such as components selected from the group consisting of memory storage components, analog-to-digital converters, rectifier circuits, state machines, microprocessors, microcontrollers, filters and other signal conditioners, sensor interface circuits, transducer interface circuits, and combinations thereof. In some embodiments, the controller 110 / 210 / 310 includes a memory storage component that includes instructions, such as instructions used by the controller 110 / 210 / 310 to execute algorithms, each 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 capacitor). In some embodiments, at least a portion of the controller 110 / 210 / 310 is implanted in the patient and adjusts and / or controls (e.g., automatically via algorithm 50) the energy delivered by the implanted portion of the associated EDM 150 / 250 / 350 (e.g., without the need for control signals sent by external components of system 10).Alternatively or additionally, the controller 110 / 210 / 310 may include at least a portion disposed outside the patient's body and wirelessly transmits control signals to an implanted portion of the EDD 100 / 200 / 300. In some embodiments, energy is wirelessly transferred to a battery, capacitor, and / or other energy storage element of the implanted portion of the controller 110 / 210 / 310, for example, via transfer of electrical energy (such as via inductive coupling and / or radio frequency signals) and / or via transmission of ultrasonic energy (such as ultrasonic energy received by one or more ultrasonic transducers and converted to electrical energy, as described herein). In these embodiments, energy may be transferred from another implanted portion of the controller 110 / 210 / 310 and / or from an externally disposed portion of the controller 110 / 210 / 310. In these embodiments, the energy delivered to treat tissue (e.g., stimulate and / or ablate tissue) may be delivered by the implantable portion of the EDM 150 / 250 / 350 at an energy setting (e.g., frequency, amplitude, waveform shape, etc.) that is independent of (e.g., different from) the energy setting of the 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 frequency of the energy delivery used to treat tissue.

[0081] The controller 110 / 210 / 310 may include one or more energy storage components, such as batteries, capacitors, and / or other energy storage components. These one or more energy storage components may be located in the external and / or implantable portions of the device 100 / 200 / 300, respectively. The energy storage components of the controller 110 / 210 / 310 may be configured to be charged via a wireless power transmission sent to the controller 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 an energy storage component of another device. In some embodiments, the device 100 / 200 / 300 includes a charging assembly (such as a wireless charger integrated into the external portion of the device 100 / 200 / 300). In some embodiments, the wireless power transmission includes electromagnetic energy that is received and stored by the controller 110 / 210 / 310 (e.g., received via the patient's tissue by a portion of the implantable controller 210 and / or 310). Alternatively or additionally, wireless power transmission may include transmission of acoustic energy (such as ultrasonic energy), light energy, and / or other non-electromagnetic energy, which is received by the controller 110 / 210 / 310 (e.g., received by a portion of the implantable controller 210 and / or 310 through the patient's tissue), converted to electrical energy (e.g., by an array of one or more ultrasonic and / or light transducers of the CEDD 200 and / or FAD 300), and stored in an embedded energy storage component of the controller 110 / 210 / 310. In some embodiments, the embedded energy storage component of the controller 210 and / or 310 is periodically charged prior to a period of use (e.g., delivery of therapy to tissue). In some embodiments, after recharging of the CEDD 200 or FAD 300 has occurred, the EDM 250 may deliver therapeutic energy (such as stimulation energy) to the tissue, or a force delivery assembly, as shown, the FAA 360, may apply a therapeutic force to the tissue, respectively.In these embodiments, recharging may occur prior to therapy delivery (eg, recharging may occur prior to delivery of therapy to a sleep apnea patient each night, as described herein).

[0082] The controller 110 / 210 / 310 may be configured in an automatic mode, for example, where the energy delivered and / or force applied by the devices 100, 200, and / or 300 is automatically adjusted (turned on, turned off, and / or changed in intensity and / or configuration, etc.). For example, system 10 may be configured to treat a patient with sleep apnea, and controller 110 / 210 / 310 may be configured to automatically perform functions selected from the following group: turning on energy delivery and / or force delivery when the patient falls asleep (e.g., as determined by the sensors and / or algorithms 50 of system 10); turning off energy delivery and / or force delivery when the patient wakes up (e.g., as determined by the sensors and / or algorithms 50 of system 10); modifying 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., becomes worse and / or more frequent, as determined by the sensors and / or algorithms 50 of system 10); and combinations thereof. In some embodiments, system 10 is configured in a manual mode (e.g., with or without an automatic mode) where the patient may simply turn on, off, and / or change the energy delivery and / or force delivery of system 10 (singly or collectively, herein, "energy delivery" or "force delivery"), for example, via voice control and / or the simple tap of a switch (such as via a user interface of system 10 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 (e.g., fallen asleep again), system 10 may automatically resume energy and / or force delivery (e.g., to prevent the occurrence of a sleep apnea event).

[0083] The console 500 may include a user interface 590, each as shown. The user interface 590 may include various controls configured to receive input from an operator of the system 10 (such as a clinician or other user of the system 10) 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 the group consisting of buttons, switches, foot pedals, levers, keyboards, mice, touch screens, microphones, and combinations thereof. The user interface 590 may include one or more user output components selected from the group consisting of displays, touch screens, lights, speakers, tactile transducers, and combinations thereof.

[0084] Similarly, EDD 100, CEDD 200, and / or FAD 300 may each include a user interface, user interfaces 190, 290, and / or 390, respectively, as shown, each including 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 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 prior to implanting the associated device 200 and / or 300 into a patient (e.g., the user interface components include sealed components and / or are otherwise configured to be implanted into a patient after first use). User interfaces 190, 290, and / or 390 (singly or collectively herein "user interfaces 190 / 290 / 390") may include one or more switches or other controls to allow a patient or other operator of system 10 to turn on, off, and / or adjust the delivery of force and / or energy delivered by 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 ID and / or other patient information collected by system 10). For example, the energy delivery options and / or other treatment parameters provided by the user interface may be altered (e.g., limited and / or expanded from a standard set of settings) based on data collected during a medical procedure performed using 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 system 10 as described herein).

[0085] System 10 may include one or more functional elements, for example, functional element 199 of EDD 100, functional element 299 of CEDD 200, functional element 399 of FAD 300, functional element 599 of console 500, and / or functional element 999, as shown. 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, e.g., wireless sensors capable of receiving power wirelessly and / or transmitting signals wirelessly.

[0086] In some embodiments, the functional elements 199, 299, 399, 599, and / or 999 include one or more sensors selected from the group consisting of an accelerometer, a gravity-based sensor, a strain gauge, an acoustic sensor (e.g., a microphone or other acoustic sensor), an electromagnetic sensor (such as a Hall Effect sensor), a pressure sensor, a vibration sensor, a temperature sensor, a vacuum sensor, a GPS sensor, a humidity sensor, a flow sensor (e.g., an air flow sensor), 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, each as defined below).

[0088] Functional elements 199, 299, 399, 599, and / or 999 may include a patient "physiological sensor" including one, two, or more sensors configured to measure a patient's "physiological parameters", such as sleep parameters (e.g., as defined below), heart rate, blood pressure, respiratory rate, sweat rate, blood gas levels, blood glucose levels, brain and / or other neural activity measured, for example, by electroencephalography (EEG), local field potentials (LFP), and / or neuronal firing (such as single neuron firing activity), eye movement, positive end-expiratory pressure (PEEP) sensors, physiological parameters measured by bone-placed sensors (such as sensors placed on the jaw, e.g., sensors 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 the patient, for example parameters selected from the group consisting of snoring parameters (e.g., snore amplitude, snore frequency, snore waveform shape, snore type, and / or other snore parameters), occurrence of sleep apnea events, sleep states (stage 1, stage 2, stage 3, REM sleep, etc.), respiratory parameters (such as breathing type such as nasal breathing and / or mouth breathing, respiratory rate, and / or other respiratory parameters), patient position during sleep (such as left side, right side, supine, and / or prone), 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 a patient's wearable device, such as a smart watch, an activity tracker (such as one worn on the patient's wrist), and / or other portable device.

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

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

[0092] In some embodiments, functional elements 199, 299, 399, 599, and / or 999 include one or more transducers selected from the 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 agent delivery assemblies, and combinations thereof.

[0093] In some embodiments, functional elements 199, 299, 399, 599, and / or 999 include an assembly or other component configured to provide a vacuum to another component of system 10. For example, functional elements 199, 299, and / or 399 may include a tissue engagement port configured to receive vacuum (e.g., from controllers 110, 210, and / or 310 and / or from console 500) and stabilize tissue, capture tissue (e.g., pull tissue toward the port), and / or otherwise engage tissue, whereupon the vacuum is applied to the port. Functional elements 199, 299, 399, 599, and / or 999 may include a vacuum source, such as a vacuum, that may be applied to such tissue engagement port. In some embodiments, functional elements 199, 299, 399, 599, and / or 999 include components configured to provide vacuum to manipulate tissue, e.g., to move tissue relative to EDM 150 / 250 / 350, e.g., to modify energy and / or force delivery to the tissue based on the tissue manipulation. Alternatively or additionally, the vacuum provided can be configured to position (e.g., and maintain the position of) the tissue relative to EDM 150 / 250 / 350.

[0094] In some embodiments, functional elements 199, 299, 399, 599, and / or 999 include a machine manipulation assembly configured to manipulate (e.g., robotically) one or more components of system 10, e.g., to manipulate the position, configuration, and / or orientation of EDM 150 / 250 / 350 relative to the patient. For example, the functional elements may include a frame positioned proximate to the patient tissue and an XY manipulator to move EDM 150 / 250 / 350 in at least two dimensions relative to the patient tissue, e.g., 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 an adhesive and / or adhesive dispensing component, for example, where an 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 a component of system 10 (e.g., a portion of device 100 / 200 / 300) to the patient's tissue and / or to another component of system 10.

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

[0097] In some embodiments, functional elements 199, 299, 399, 599, and / or 999 include assemblies or other components configured to apply a force to tissue (e.g., a gripping component configured to apply tension to the tissue and / or a pushing element configured to provide a compressive force to the tissue), e.g., to provide a force (such as a tension and / or compression force) to tissue (such as a target tissue) while energy is 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 position of components of system 10 (such as EDM 150 / 250 / 350) and / or the patient (such as a target tissue of the patient). In these embodiments, the position information of the patient and / or system 10 can be used to deliver energy and / or force in a closed loop configuration, e.g., to vary delivery based on movement of the patient and / or components of system 10 (e.g., redirect and / or adjust delivery to compensate for movement, such as via algorithm 50).

[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) that are configured to deliver a substance (such as a fluid and / or other flowable substance), for example, to a location proximate to a target tissue during energy delivery to the target tissue (such as to cool and / or warm the tissue). In some embodiments, the substance delivered includes an agent 920 (such as a pharmaceutical or other agent delivered to a patient) as described herein.

[0100] In some embodiments, the functional element 299 includes a sensor configured to be placed on the patient's skin and / or implanted within the patient's body, for example to measure a sleep parameter of the patient. 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, for example to measure the patient's snoring level or other sleep parameter.

[0101] In some embodiments, the functional element 999 includes a mobile phone, a tablet, a computer (such as a laptop computer), an alarm clock, a bed shaker, an alarm device, and combinations thereof. The functional element 999 may include a mobile phone, a laptop, a tablet, a camera, and / or a patient support device including one, two, or more sensors, for example sensors configured to measure a patient physiological parameter (such as a sleep parameter) and / or a patient environmental parameter, each as described herein. In some embodiments, the functional element 999 includes one, two, or more of these sensors (such as a patient physiological sensor and / or a patient environmental sensor) located in the imaging device 910, the treatment device 930, the consumption device 940, and / or the tool 950, each as described herein.

[0102] System 10 may include one or more accessory devices used to treat and / or diagnose a patient, which may include accessory device 900 as shown. In some embodiments, accessory device 900 includes one or more imaging devices, as shown, imaging device 910. 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, fluoroscopic imaging devices or other x-ray based imaging devices, and combinations thereof. In some embodiments, imaging device 910 provides image data ID to system 10 such that one or more of devices 100 / 200 / 300 may be navigated via the provided image data ID. For example, the imaging device 910 may include an MRI or ultrasound imaging device that provides image data ID that is configured to direct (e.g., automatically and / or manually) energy delivery (such as focused ultrasound and / or other energy delivery) to tissue by the EDM 150 and / or EDM 250 and / or direct (e.g., automatically and / or manually) the delivery of force to tissue by the FAA 360. In some embodiments, the imaging device 910 includes an ultrasound imaging device that provides positive end-expiratory pressure (PEEP) measurements to quantify and / or monitor the effectiveness of treatment provided by the system 10 described herein. In some embodiments, the device 100 / 200 / 300 is constructed and arranged to include the imaging device 910 (e.g., the device 100 / 200 / 300 includes an array of ultrasound elements and / or optical elements that are configured to generate image data ID via transmission and / or reception of ultrasound energy and / or light energy, respectively, as described herein).

[0103] In some embodiments, the accessory device 900 includes one or more active agents, illustrated as active agent 920. The active agent 920 may include one, two, or more active agents selected from the group consisting of a pharmaceutical agent, a cooling agent, a warming agent, a lubricant, a conductive agent, such as an acoustically, electrically, and / or thermally conductive gel, a magnetic agent, a visibility agent, such as a radiolucent agent, a magnetic reflective agent, and / or an ultrasound reflective agent, and combinations thereof.

[0104] In some embodiments, the accessory device 900 includes one or more treatment devices, such as the illustrated treatment device 930. In some embodiments, the treatment device 930 includes an implant configured to be inserted into the patient's soft palate or other airway tissue to stiffen and / or dampen the tissue and / or deflect, compress, and / or cause the tissue to reposition out of the airway (such as to reduce the likelihood of a sleep apnea event). In some embodiments, the treatment device 930 includes a stent, such as a temporary or permanent stent, that is placed in a segment of the nasal cavity and / or other patient airway segment to affect the shape of the segment (such as after a treatment of the system 10 has been performed on or near the segment, as described above). In some embodiments, the treatment device 930 includes a distraction device, such as a jaw distraction device. In some embodiments, the treatment device 930 includes a surgical tool, such as a scalpel, an electrosurgical cutting and / or hemostatic device (also referred to as a "bobby"), a retractor, a clamp, a fastening device, such as sutures, staples, adhesives, etc., and combinations thereof. In some embodiments, the algorithm 50 is configured to automatically or semi-automatically (herein "automatically") control the treatment device 930. For example, the energy delivery and / or other treatments delivered by the treatment device 930 may be delivered in a closed loop configuration via the algorithm 50. In some embodiments, the algorithm 50 controls the operation of the treatment device 930 based on an analysis of image data ID (such as ultrasound-based image data ID described herein) collected by the system 10. The image data ID used by the algorithm 50 to control the treatment device 930 may provide control of the treatment device 930 immediately after it is collected by the system 10, for example, the image data ID is collected (e.g., at least a portion is collected) within 5 minutes, within 3 minutes, and / or within 1 minute of control of the treatment device 930 by the algorithm 50.

[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 the group consisting of a mobile phone (such as a cell phone), a watch (such as a smart watch), a camera, an alarm clock, a computer, such as a laptop computer or a tablet, a bed, such as a motorized adjustable bed, a nightstand device, such as a clock and / or a lamp, and combinations thereof.

[0106] In some embodiments, the accessory device 900 includes one or more tools, as illustrated, tool 950. Tool 950 may include one, two, or more components selected from the group consisting of a bed, such as a powered 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 (such as an adjustable bed or other tool) that adjusts the patient's position to reduce the patient's snoring and / or reduce the likelihood of an apnea event, for example, the adjustment is initiated and / or otherwise controlled 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, ultrasonic, light, and / or other energy to a separate device to charge the device. In these embodiments, the device 100 / 200 / 300 may include a tool 950 (e.g., 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 (e.g., to allow some patient movement during energy delivery while preventing undesired energy delivery to non-target tissue). In these embodiments, the tool 950 may include a tool that may be attached to the patient's jaw and / or that may maintain the patient's jaw in a particular 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, tool 950 is customized for a particular patient, for example, where tool 950 is manufactured and / or otherwise configured based on photographs of the patient and / or medical images of the patient's tissue (such as ultrasound images, x-rays, or other medical images, e.g., 2D or 3D images generated by a scanning device, etc.).The tool 950 may include a manipulation tool, which may be configured to manipulate the EDM 150 / 250 / 350 relative to a patient's tissue, as described herein. In some embodiments, the tool 950 is configured to position the EDM 150 / 250 / 350 in one, two, or three dimensions relative to a target tissue, such as a target tissue of the tongue.

[0107] The accessory device 900 may include a functional element 999 as described above and elsewhere herein. In some embodiments, the consuming device 940 includes the functional element 999, such as when the consuming device 940 includes a bed or other device that is placed in proximity to a patient during sleep, and the functional element 999 includes one or more sensors configured to measure patient parameters, such as sleep parameters of the patient.

[0108] System 10 may include network 600 as shown, which may include one, two, or more wired and / or wireless computer networks, such as the Internet, local area networks, cellular networks, and / or other data sharing, storage, and / or transmission platforms. Network 600 may be configured to transfer data between two or more system 10 components, 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 system 10 components when system 10 is configured to transfer information in a cloud-based configuration. Network 600 may be used to transfer and / or store patient information and / or system 10 usage information, such as when algorithm 50 (such as an AI algorithm) is configured to analyze information from one patient and / or a group of patients to tailor use of system 10 for these or other patients (e.g., via the creation of a treatment plan, as described herein).

[0109] The EDD 100 and / or CEDD 200 (single or collectively referred to herein as “Devices 100 / 200”) may each include an Energy Delivery Module, EDM 150 and / or EDM 250, respectively, as shown. In some embodiments, the FAD 300 includes an Energy Delivery Module, as shown as EDM 350, such that the FAD 300 can both apply forces to tissue and deliver energy to tissue (e.g., deliver energy to image and / or ablate tissue). The EDMs 150, 250, and / or 350 (single or collectively referred to herein as “EDM 150 / 250 / 350”) may be configured to deliver one, two, or more forms of energy to tissue to perform tissue diagnostic and / or tissue therapeutic procedures, as described above and herein. The EDM 150 / 250 / 350 may be configured to deliver and / or receive energy to and / or from tissue and generate image data ID of the tissue, for example, where energy (such as ultrasound energy and / or light energy) is delivered by at least a portion of the EDM 150 / 250 / 350 and reflected energy (such as reflected ultrasound energy and / or light energy, respectively) is received by a similar and / or different portion of the EDM 150 / 250 / 350, such that image data ID may be created based on the transmitted and received energy. In some embodiments, the system 10 is configured to generate image data ID including 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, as also described herein, may be configured to determine tissue temperature information and / or tissue ablation information based on other image data ID generated via energy delivered and / or received by EDM 150 / 250 / 350.In some embodiments, the EDM 150, 250, and / or 350 includes an array of energy delivery and / or energy receiving components, energy delivery elements 159, 259, and / or 359, respectively, such as 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, the EDM 150 / 250 / 350 is configured to be controlled (such as in a closed loop or other automated configuration) via an algorithm 50 (such as an AI or other algorithm configured to control the EDM 150 / 250 / 350 based on image data ID and / or other data collected by the system 10). In some embodiments, the EDM 150 / 250 / 350 is of a similar structure and arrangement to Applicant's co-pending International PCT Patent Application No. PCT / US2021 / 063743, entitled "Tissue Interface System," filed on December 16, 2021 [Docket No. USD-003-PCT].

[0110] The EDD 100 and / or CEDD 200 may each include a component configured to reflect energy, such as mirrors 155 and / or 255, respectively, as shown. The mirrors 155 and / or 255 (singly or collectively referred to herein as "mirrors 155 / 255") may each include one or more mirrors, such as one or more acoustic mirrors (such as mirrors configured to reflect and redirect ultrasonic energy to a target tissue). In some embodiments, the mirrors 155 / 255 include mirrors configured to reflect optical energy and / or another form of energy. The mirrors 155 / 255 may be constructed, placed, and / or positioned at the location of the tissue such that the delivered energy is directed (or redirected) to the target tissue. The mirrors 155 / 255 may be placed within the patient's body temporarily (such as for less than a day) and / or chronically (such as for at least one week, one month, or three months).

[0111] The FAD 300 may include a Force-Applying Assembly, FAA 360, as shown. The FAA 360 may include one, two, three, or more controllable actuator portions (herein "actuators"), such as actuators that bend, curl, cantilever, rotate, and / or otherwise adjust their shape based on applied voltage and / or current, temperature changes, and / or other drive signals of the FAD 300. In some embodiments, the FAA 360 includes a first actuator that applies a force to a first tissue location (e.g., a location including a first tissue type, such as muscle), and at least a second actuator that applies a force to a second tissue location (e.g., a location including the same type of tissue and / or a different type of tissue). The FAA 360 may include three or more actuators. In some embodiments, the FAA 360 includes multiple actuators that are independently deployable (e.g., controlled by the controller 310) and are deployed in different manners (e.g., different shapes and / or different forces applied to tissue) to optimize treatment (e.g., via an optimization procedure in which the deployment of the actuators is titrated or otherwise optimized for a particular patient's anatomy and / or other physiological parameters specific to that patient).

[0112] The FAA 360 may include a piezoelectric-based actuator that changes shape based on a drive signal (e.g., an applied voltage). The FAA 360 may include a shape memory alloy and / or a shape memory polymer that causes the FAA 360 to change shape when its temperature changes (e.g., via heating with an applied current and / or cooling with a thermoelectric cooler and / or other cooling element). The FAA 360 may include an electromechanical assembly that includes motors, gears, actuators, cams, and / or other components that may be remotely controlled (e.g., via the controller 310) to transition between a non-deployed state and a deployed (e.g., force-delivery) state.

[0113] In some embodiments, the FAA 360 includes one, two, or more bimorph actuators, such as a piezoelectric bimorph actuator that includes a first layer that contracts and a second layer that expands when a voltage is applied to the actuator. Alternatively or additionally, the FAA 360 may include one, two, or more unimorph actuators (e.g., a piezoelectric actuator configured as a cantilever that includes one active layer and one inactive layer).

[0114] The FAD 300, via the controller 310, may provide a drive signal to the FAA 360, including an alternating current (AC) and / or direct current (DC) drive signal. The AC drive signal may be sent to the FAA 360 (e.g., to a piezoelectric actuator as described above) to cause a back and forth movement, to provide a function selected from the group consisting of, for example, providing a varying force to tissue to tone, strengthen, and / or augment muscle tissue (e.g., muscle tissue of a patient's airway), and to apply a force to tissue of the airway to accommodate the patient's breathing (e.g., an AC signal synchronized with the patient's breathing). The amplitude of the AC drive signal may correlate to a deflection distance and / or force applied to the tissue by the FAD 300. The DC drive signal may be sent to the FAA 360, for example, the DC signal is applied continuously, intermittently, or both. Similarly, the magnitude (e.g., voltage level) of the DC signal may correlate to a deflection distance and / or force applied to the tissue by the FAD 300. A DC signal may be applied to generate a fixed force applied to tissue and / or a fixed geometric adjustment (such as a fixed distance of actuation).

[0115] The FAA 360 may be configured to provide an adjustable force (e.g., by adjusting the magnitude of an AC or DC signal) such that the force may be adjusted in a procedure configured to optimize patient treatment, such as 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 FAA 360 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 FAA 360 are adjusted independently and / or as a set.

[0116] The FAA 360 (and / or other portions of the FAD 300) may include one or more portions disposed on and / or within tissue, such as airway tissue, muscle tissue, and / or other tissue to be scaffolded and / or augmented (e.g., strengthened). The FAA 360 may be secured to bone or other tissue, such as in one, two, or more locations. The FAA 360 may be secured to bone or other tissue using screws, staples, sutures, and / or other fixation elements. In some embodiments, the FAA 360 and / or FAD 300 includes an arch-like structure (shown in FIG. 7) that may be secured to tissue by its shape without the need for a separate fixation element. In these embodiments, the FAA 360 and / or FAD 300 may be inserted and removed multiple times (e.g., periodically).

[0117] The FAA 360 may be driven by a relatively low frequency AC drive signal and / or a DC signal and may have a thickness of several millimeters. The FAD 300 may include a first portion 300a that is implanted and includes the FAA 360, and the first implanted portion 300a receives power from a second portion 300b (e.g., a second implanted portion or a portion disposed on the patient's skin in close proximity to the first implanted portion). The power delivered by portion 300b may include ultrasonic energy transmitted at a frequency of several MHz (e.g., a resonant frequency of the FAD 300, which is several millimeters thick). The first implanted portion of the FAD 300 may obtain the received ultrasonic energy (e.g., via one or more piezoelectric transducers and / or CMUTs) and convert it to 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 FAA 360, the FAA 360 may be "directional" at the frequency of the power supply. In some embodiments, the second portion 300b includes ultrasonic elements arranged as a focused array (such as a large aperture) configured to deliver focused ultrasonic waves to a receiving set of ultrasonic elements in the first portion 300a. The ultrasonic elements in the second portion 300b may include a 2D array of ultrasonic elements that power the first portion 300a.

[0118] In some embodiments, the FAA 360 is constructed and arranged as described with reference to Figures 2, 6A-6B, and / or 7 herein.

[0119] In some embodiments, the EDD 100 and / or the CEDD 200 include a force delivery assembly, not shown, of similar construction and arrangement to assembly 360 of the FAD 300 described herein.

[0120] For example, the EDD 100, CEDD 200, and / or FAD 300, respectively via EDM 150 (e.g., via an array of one, two, or more elements 159), EDM 250 (e.g., via an array of one, two, or more elements 259), and / or EDM 350 (e.g., via an array of one, two, or more elements 359), and / or other components of system 10 may be configured to deliver energy in one, two, or more forms of energy, e.g., the one, two, or more forms of energy selected from the group consisting of acoustic energy, such as high intensity focused ultrasound (HIFU) energy, other focused ultrasound energy, plane wave ultrasound energy, and / or other ultrasound energy; light 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 (e.g., to the EDD 100 when the EDD 100 is operably attached 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 another form of energy) to perform a tissue reduction procedure (e.g., a tissue ablation procedure, a lithotripsy procedure, and / or a histotripsy procedure) and / or to perform a tissue augmentation procedure (e.g., a nerve or muscle stimulation procedure) to a patient.

[0121] EDM 150 / 250 / 350 may include one or more energy delivery elements 159, 259, and / or 359, respectively, that are used to collect image data, for example, by receiving reflected energy (such as energy reflected from energy delivered by the same or other elements). Elements 159, 259, and / or 359 (singly or collectively elements 159 / 259 / 359) may include a 1D or 2D array of elements (such as ultrasound elements). Elements 159 / 259 / 359 may include horizontal and / or vertical arrangements of elements. Elements 159 / 259 / 359 may include an array of elements (such as ultrasonic elements) configured in an arrangement selected from the group consisting of a plurality of 1D arrays of elements, a flat array of elements, a curvilinear array of elements, an arrangement of elements in the form of a flexible wrap (such as described with reference to Figures 4 and / or 5 herein), an array of elements disposed at the end of an elongated probe and including a diameter approximating the diameter of the probe (such as described with reference to Figure 15 herein), an array of elements disposed at the end of an elongated probe and including a diameter larger than the diameter of the probe (such as described with reference to Figure 16 herein), an array having a spoon shape or other convex and / or concave shape (for sufficient contact with the surface of the patient's tongue to deliver energy, for example, to sub-surface tissue of the tongue, as described with reference to Figures 18A-18B herein), a tubular array of elements (such as a solid or hollow tubular structure), a partially circumferential array of elements, and combinations thereof. In some embodiments, the EDM 150 / 250 / 350 can include a geometry (such as a geometry including elements 159 / 259 / 359) configured to hold and / or stabilize tissue that will receive energy from elements 159 / 259 / 359, for example, the arrangement has a cup (such as described with reference to FIG. 9 herein), a cone (such as described with reference to FIG. 10 herein), and / or a cylinder (such as a full or partial circumferential cylinder, as described with reference to FIG. 11 herein).Alternatively or additionally, EDM 150 / 250 / 350 may include one or more vacuum ports (e.g., functional elements 199, 299, and / or 399 each including one or more vacuum ports) configured to stabilize tissue (as described with reference to FIGS. 9, 10, and / or 11 herein). In some embodiments, device 100 / 200 / 300 may be configured to compress tissue receiving energy (such as energy for ablation and / or stimulation), such as when device 100 is manipulated by an operator and / or a component of system 10 (such as a robotic manipulator) to compress tissue prior to and / or during delivery of energy to the tissue by EDM 150 / 250 / 350.

[0122] In some embodiments, the EDM 150 / 250 / 350 and / or another portion of the device 100 / 200 / 300 includes an adjustable geometry, such as an adjustable diameter of the cups, cones, and / or cylinders of the array of elements 159 / 259 / 359 (e.g., as described with reference to FIGS. 9, 10, and 11 below). In these embodiments, an operator may adjust the geometry to suit the characteristics of the tissue to be treated (e.g., to accommodate the dimensional characteristics of the patient's tonsils, tongue, and / or other tissue to be treated). In some embodiments, one or more portions of the device 100 / 200 / 300 include a geometry (e.g., an adjustable geometry) such that a force (e.g., an adjustable force) can be applied to the target tissue, such as a tensile force and / or a compressive force being applied to the target tissue (e.g., the target tissue to be ablated). In some embodiments, the system 10 includes a kit of multiple devices 100 / 200 / 300 and / or EDM components 150 / 250 / 350 (such as attachable versions), which may have different geometries (e.g., different dimensions of the tissue contacting portions of these components, e.g., to apply a desired force and / or to accommodate the geometry of the tissue to be treated). In these embodiments, the clinician may select from the kit of components a component that optimizes the treatment (e.g., optimizes tissue imaging and / or energy delivery in the treatment).

[0123] The EDM150 / 250 / 350 includes an array of ultrasound transducers that delivers ultrasound energy (e.g., via all or a portion of the set of ultrasound transducers) at a minimum frequency or higher (e.g., a frequency of 10 MHz or higher, a frequency between 10 MHz and 20 MHz, etc.) to create image data ID (image tissue and / or other objects on and / or within the patient) while delivering ultrasound energy (e.g., via the same or a different set of ultrasound transducers) at a maximum frequency or lower (e.g., a frequency of 10 MHz or lower, or 5 MHz or lower) to ablate tissue. For example, the EDM150 / 250 / 350 may image tissue using ultrasound delivered at 10 MHz or higher and ablate tissue via HIFU energy delivery at a frequency less than 10 MHz, e.g., less than 5 MHz.

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

[0125] The EDM 150 / 250 / 350 may include one or more energy delivery elements 159, 259, and / or 359, respectively, that are used to collect image data, for example, by receiving reflected energy (such as energy reflected from energy delivered by the same or other elements). The elements 159, 259, and / or 359 (singly or collectively elements 159 / 259 / 359) may include a 1D or 2D array of elements (such as ultrasound elements). The elements 159 / 259 / 359 may include an array of elements (such as ultrasound elements) configured in an arrangement selected from the group consisting of multiple 1D arrays of elements, a flat array of elements, a curved array of elements, an arrangement of elements in the form of a flexible wrap (such as those described with reference to Figures 4 and / or 5 herein).

[0126] The EDM150 / 250 / 350 may include one, two, or more arrays of ultrasound transducers that cause thermal ablation via delivery of focused ultrasound (such as HIFU). The EDM150 / 250 / 350 may include one, two, or more arrays of ultrasound transducers configured to perform lithotripsy and / or histotripsy. The EDM150 / 250 / 350 may include one, two, or more arrays of ultrasound transducers that deliver ultrasound energy to heat tissue to a non-ablative 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 2 minutes or less). In these non-ablative 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 EDM 150 / 250 / 350 may be configured to deliver ultrasonic energy at non-ablative levels that provide a "thermal massage effect" to tissue to tighten and / or augment tissue, such as muscle tissue.

[0127] The EDM 150 / 250 / 350 may include an array of ultrasonic transducers configured to deliver ultrasonic energy at a frequency that may be adjusted (e.g., by a clinician and / or automatically by the system 10). For example, the EDM 150 / 250 / 350 may be configured to deliver ultrasonic energy (e.g., plane wave delivery of ultrasonic energy) to a target tissue including a tissue volume with a particular thickness, and ablate from a tissue surface proximate to the ultrasonic array to a maximum depth from the array, where the depth of ablation is dependent on the frequency of the delivered ultrasonic energy (e.g., ablation of a controlled depth of tissue).

[0128] The EDM150 / 250 / 350 may include an array of ultrasound transducers (such as a 2D array of ultrasound introducers) configured to deliver focused ultrasound energy to ablate multiple tissue locations (e.g., simultaneously or sequentially), e.g., 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 ablated 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 that deliver HIFU and / or other focused ultrasound at a frequency between 5-10 MHz. The multiple tissue locations may each include a relatively small volume of tissue, e.g., a volume of tissue approximately 0.5 mm by 3.0 mm, or 1 mm by 6.0 mm in length and width. In some embodiments, multiple relatively small volumes of tissue are ablated to avoid significant swelling that would occur if a larger volume of tissue were ablated.

[0129] The EDM150 / 250 / 350 may include an array of ultrasonic transducers configured to deliver ablative ultrasonic energy to ablate tissue while avoiding the formation of scabs, for example, as described herein, when ultrasonic energy is delivered to subsurface tissue while avoiding adverse effects on superficial tissue.

[0130] The EDM 150 / 250 / 350 and / or imaging device 910 may collect image data ID including data related to target and / or non-target tissue (e.g., data that may be used to distinguish between target and non-target tissue and / or tissue types such as muscle, fat, nerve, etc.). The image data ID including these two forms of data may be used manually by an operator of the system 10 and / or automatically by the algorithm 50 to determine one or more energy delivery settings, as described herein, e.g., energy delivery settings that cause ablation of the target tissue without damaging the non-target tissue. In some embodiments, the image data ID may include data related to a level of ablation or other damage to the tissue, as described herein. In these embodiments, the algorithm 50 may be configured to stop the delivery of energy when sufficient ablation of the target tissue is confirmed (e.g., to avoid damage to adjacent tissue) and / or when damage to the non-target tissue (e.g., any damage) is detected. In some embodiments, the algorithm includes a bias, for example, a bias that tends to avoid damage to non-target tissue (such as a bias that may result in a portion of the target tissue being unablated or untreated) or a bias that tends to ensure that all of the target tissue is ablated or otherwise treated (such as a bias that may result in a portion of the non-target tissue being ablated or damaged).

[0131] The EDM 150 / 250 / 350 and / or imaging device 910 may collect image data ID including data related to the patient's blood conduits, such as arteries, veins, and / or heart chambers. The image data ID including blood conduit data may be used to avoid (e.g., manually by an operator and / or automatically via algorithm 50) delivery of ablative energy to the blood conduit (e.g., the blood conduit and blood therein are non-target tissue). Alternatively or additionally, the image data ID including blood conduit data may be used to cause (e.g., manually by an operator and / or automatically via algorithm 50) ablation of the blood conduit (e.g., causing subsequent tissue death supplied by that particular blood conduit). In some embodiments, the image data ID includes data related to air or other gas pockets within the patient, for example, gas pockets (e.g., identified by algorithm 50 and / or operator) that should be avoided in the delivery of energy (such as ultrasound energy) by the EDM 150 / 250 / 350. For example, in some embodiments, the trajectory of energy delivery from the EDM 150 / 250 / 350 to the target tissue to be ablated must avoid gas pockets. Avoidance of gas pockets using image data ID can be performed manually by an operator of the system 10 and / or automatically by the algorithm 50.

[0132] In some embodiments, the EDM 150, 250, and / or 350 are configured to deliver ultrasound energy to tissue, such as focused ultrasound (such as HIFU or other focused ultrasound) and / or unfocused ultrasound energy delivery. In these embodiments, the EDM 150 / 250 / 350 may include an array of energy delivery elements (such as element 159 for EDM 150, element 259 for EDM 250, and / or element 359 for EDM 350), including 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 EDM 150 / 250 / 350 includes an ultrasound-based array including 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 the one or more piezoelectric transducers and the one or more CMUT transducers. The algorithm 50 is configured to compare results of functions (e.g., imaging functions) performed by both the piezoelectric transducers and the CMUT transducers, distinguish between the two results (e.g., utilize one result with the other), and / or combine the results to generate a new set of results based on both the piezoelectric data and the CMUT data. In some embodiments, ultrasound imaging is performed, where the piezoelectric transducer emits ultrasound waves and the CMUT transducer receives reflections of the emitted waves (e.g., reflections from various surfaces of tissue or other objects). The ultrasound 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 EDM 150 / 250 / 350 may be received by a separate component of the system 10 (such as an implanted or other portion of the EDM 150 / 250 / 350), where the separate component converts the received ultrasonic energy into electrical energy that is delivered (e.g., via a voltage applied by one or more electrodes, as described herein with reference to Figures 4-5) to stimulate and / or treat tissue.

[0133] The EDM 150, 250, and / or 350 may be configured to deliver energy (such as ultrasonic energy) at a relatively low power density and stimulate the tissue without adversely affecting the tissue (e.g., avoid cell death and stimulate the tissue without adversely affecting the cells of the tissue). Alternatively or additionally, the EDM 150 / 250 / 350 may be configured to deliver energy (such as ultrasonic energy) at an energy delivery setting that causes cell death, for example, via 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 device 100, 200, and / or 300 described herein may be configured to allow an operator of the system 10 (e.g., via a user interface of the system 10) to transition between the device delivering a tissue augmentation treatment (such as stimulation) and the device performing a tissue reduction treatment (such as thermal ablation and / or tissue destruction). The system 10 may be configured to allow adjustment (eg, manual or automatic) between continuous and pulsed delivery of energy, as well as adjustment of the frequency of energy delivery (eg, the frequency of the delivered ultrasonic energy).

[0134] The EDMs 150, 250, and / or 350 can be configured to deliver ultrasonic energy to tissue as described herein. Ultrasonic energy can be delivered by the EDMs 150 / 250 / 350 to stimulate tissue (such as neural tissue), and ultrasonic energy can be greater than 50 W / cm2. 2For example, ultrasonic energy may be delivered at a power density of at least 100 W / cm 2 may be delivered by the EDM 150 / 250 / 350 in a HIFU configuration when delivered at a power density of 100 MPa. In some embodiments, the EDM 150 / 250 / 350 is configured to perform tissue ablation on tissue when a pressure level of 50 MPa is delivered.

[0135] EDM 150, 250, and / or 350 can include an assembly including one or more Peltier elements configured to heat and cool target tissue (e.g., tissue on one side of the Peltier element is cooled and tissue on the other side of the Peltier element is heated), move tissue, strengthen tissue, and / or massage tissue.

[0136] The EDD 100 and / or CEDD 200 may each include a spacer element, spacer 151 and / or spacer 251, respectively. In some embodiments, the FAD 300 includes a spacer element, not shown, of a similar structure and arrangement to the spacers 151 and / or 152 described herein. The spacers 151 and / or 251 (singly or collectively referred to herein as "spacers 151 / 251") may include an element configured to be positioned between the EDM 150 and / or EDM 250 and a tissue surface when the EDD 100 and / or CEDD 200 are delivering energy to the target tissue, respectively. The spacers 151 / 251 may include balloons, reservoirs, and / or other fluid-containing structures configured to expand and / or contract when fluid is added and / or removed, respectively. In some embodiments, the spacer 151 / 251 includes water or other acoustically conductive material (e.g., having an impedance close to that of tissue) such that ultrasound waves delivered from the EDM 150 and / or EDM 250 (singly or collectively, “EDM 150 / 250”) pass through the spacer 151 / 251 into the patient's body in a predictable manner. In some embodiments, the spacer 151 / 251 has an adjustable thickness to allow an operator to adjust (e.g., manually adjust) the distance between the EDM 150 / 250 and the tissue surface and / or to allow the EDD 100, CEDD 200 and / or another component of the system 10 to adjust (e.g., automatically adjust) the distance between the EDM 150 / 250 and the tissue surface. The system 10 may be configured to automatically adjust the thickness of the spacer 151 / 251, such as via an AI-based algorithm 50. The spacer 151 / 251 may be temporarily or permanently attached to the housing of the device 100 and / or 200. In some embodiments, the spacer 151 / 251 is configured to be removably attached (e.g., adhesively attached) to the patient's skin (e.g., on one side of the spacer 151 / 251) and / or to the housing of the device 100 and / or 200 (e.g., on the other side of the spacer).The spacer 151 / 251 may include a visual grid on a surface to guide mounting of the housing of the device 100 and / or 200 in multiple positions. In some embodiments, the spacer 151 / 251 may be configured to provide cooling functionality to extract heat from the EDM 150 / 250 and / or from the patient's tissue. In some embodiments, the spacer 151 / 251 includes an electrode, for example, a return electrode used to enable delivery of monopolar electrical energy by an electrode of the device 100 and / or 200 (such as electrode 2120 described below).

[0137] In some embodiments, one or more components of the system 10 include at least a "resorbable" portion, i.e., a portion configured to be implanted in the patient and safely degrade over time. In some embodiments, at least a portion of the CEDD 200, the FAD 300 (such as at least a portion of the FAA 360), and / or the treatment device 930 (such as a stent-type or other scaffold-type device) is resorbable. In some embodiments, one or more components of the system 10 include a resorbable polymer and / or resorbable magnesium. In some embodiments, a component of the system 10 configured to apply a force to tissue and / or stabilize another component of the system 10 within the tissue includes a resorbable material (e.g., the force and / or stabilization provided is temporary).

[0138] The system 10 may be configured to identify treated (e.g., ablated) tissue to appropriately treat adjacent tissue (e.g., perform sequential treatment of a volume of tissue) and / or avoid undesired treatment of already treated tissue. In some embodiments, the algorithm 50 analyzes the image data ID collected by the system 10, and the algorithm 50 records the treated (e.g., ablated) tissue, for example, by identifying and recording one or more anatomical landmarks for the tissue receiving energy (and recording the information as the image data ID, etc.). Alternatively or additionally, the algorithm 50 may identify the treated tissue by analyzing the image data ID and identifying treatment features visible in the tissue after treatment (e.g., after ablation). In some embodiments, the algorithm 50 is configured to perform elasticity analysis and / or other tissue property analysis to identify the treated tissue or to locate markers of the treated tissue, as described immediately below. In some embodiments, the system 10 is configured to provide one, two, or more markers (e.g., one or more markers located within, on the periphery of, and / or adjacent to the treated tissue) that are used to "mark" tissue (e.g., permanently and / or temporarily mark tissue) and identify tissue that has been ablated or otherwise treated by the system 10. The EDM 150 / 250 / 350 may be configured to deliver energy (e.g., HIFU energy) at a particular level (e.g., a higher energy level than the remainder of the treated tissue) that causes an identifiable characteristic in the treated tissue (e.g., the energy delivery causes cavitation in the treated tissue, which may later be identified by the system 10). In some embodiments, a clinician using the device 100 may create one or more markers in the patient's tissue (e.g., near one or more tissue targets), and the clinician (e.g., manually) and / or the algorithm 50 (e.g., in an automated or semi-automated manner) may use the markers to complete a tissue treatment procedure based on the previously created markers.

[0139] In some embodiments, the system 10 may be configured to classify tissue (e.g., via the algorithm 50), e.g., to distinguish treated tissue from untreated tissue and / or one type of tissue from another type of tissue. For example, the system 10 may be configured to perform tissue elastography to classify tissue, e.g., where the EDM 150 / 250 / 350 (e.g., configured to deliver ultrasonic energy) and / or the imaging device 910 (e.g., MRI) delivers low frequency vibrations configured to measure the elasticity (e.g., stiffness) of the tissue. In some embodiments, the system 10 is configured to measure the elasticity of a portion of the tissue to determine a level of tissue ablation (e.g., ablation delivered by the system 10) and / or whether the tissue portion requires treatment (e.g., to be treated depending on the current elasticity level). Alternatively or additionally, the system 10 may be configured to track energy delivery (e.g., as a correlation with the image data ID) to track treated and untreated tissue. Identification and / or tracking of treated and untreated tissues can be very important, for example, to avoid undesired multiple treatments to a single tissue location and / or to prevent "missing" treatments to certain tissue locations associated with improved efficacy of the overall procedure. Identification and / or tracking of treated and untreated tissues can be particularly important when the treatment procedure includes treatment of multiple (such as at least 5, 10, 25, or 50) different tissue targets with individual ablative energy delivery (e.g., to treat multiple targets within a patient's tongue or other airway tissue location). In some embodiments, the tissue targets treated and / or to be treated include anatomical locations (such as multiple tongue and / or other airway locations that are treated in a non-contiguous manner) where tracking of treated and untreated tissues is desired to prevent undesired multiple energy delivery 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 a "marking energy," which includes energy (such as ultrasound energy) delivered at a set of energy delivery settings that are different from those used simply to ablate tissue (e.g., energy delivered at a higher level than standard ablation energy to cause a detectable change in the marked tissue). In some embodiments, system 10 is configured to deliver the marking energy in a specific pattern to mark tissue (such as two, three or more lines of HIFU or other energy delivery), a pattern that can be detected, for example, via algorithm 50 using a pattern recognition algorithm. System 10 may be configured to deliver the marking energy along various locations along the periphery of a volume of tissue that has been ablated (and / or is to be ablated) by system 10 to create an identifiable (e.g., via algorithm 50) "treatment border." In some embodiments, algorithm 50 is configured to identify specific tissue types and / or combinations of tissue types (herein either or both "tissue types") and identify these specific tissue types in the image data ID. The tissue type data ("data TTD") may be used in planning a treatment procedure (e.g., defined as reference points), where certain tissue types are to be avoided for treatment (e.g., used as treatment boundaries), and / or certain tissue types may be treated (e.g., receive ablation energy). In some embodiments, the tissue type data TTD includes nerve location data, bone location data, vessel wall location data, and / or blood location data, such as where identified tissue includes tissue that is to be preserved (e.g., characterized as non-target tissue and not ablated).In some embodiments, the system 10 (e.g., algorithm 50) is configured to provide a treatment plan using (e.g., based on) two or more of tissue type data TTD information, marked tissue information (e.g., tissue marked by EDM 150 / 250 / 350 described herein, e.g., tissue identifiable by image analysis, elastography, and / or other analysis performed by algorithm 50), and / or clinician-provided information (e.g., including clinician confirmation information). In some embodiments, the algorithm 50 includes an AI algorithm configured to perform an elastography analysis that distinguishes between treated and untreated tissue (e.g., and further records the results in the image data ID and / or registration data RD). In these embodiments, the treatment plan (e.g., created by the clinician, the system 10, or both) can safely include energy delivery to multiple targets in a non-sequential manner, avoiding, for example, adverse effects on non-target tissue (e.g., high temperatures that may result from 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 at least identify (and, such as enter a warning mode) patient movement and / or undesirable movement of the EDM 150 / 250 / 350 relative to the patient.

[0140] The system 10 may be configured to generate a temperature map of a target tissue being treated, e.g., 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 proximate to the location of the target tissue. The temperature map generated by the system 10 may be generated during energy delivery (e.g., in real-time), e.g., where the temperature map is used to adjust energy delivery by the EDM 150 / 250 / 350 and / or to identify ablated tissue zones (e.g., from non-ablated zones, as described herein). In some embodiments, the imaging device 910 comprises an MRI, and the system 10 is configured (e.g., via the algorithm 50) to generate the temperature map based on MR thermometry.

[0141] In some embodiments, the system 10 is configured to deliver energy (e.g., ablation energy, marking energy, and / or other energy) to a first set of one or more specific volumes of the target tissue using a first set of energy delivery settings, and deliver energy (e.g., ablation energy, marking energy, and / or other energy) to a second set of one or more specific volumes of the target tissue using a second set of energy delivery settings. The first and second sets of treated target tissues may include multiple separate 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 ablated in sleep apnea treatment procedures), hair follicles or other hair segment tissue (such as those ablated in hair removal procedures), tumor tissue (such as those ablated in cancer or other tumor treatment procedures), prostate tissue (such as those ablated in BPH treatments), and / or brain tissue (such as those treated in epileptic foci or other brain tissue treatment procedures). In these embodiments, there can be differences in the first and second energy delivery settings, for example, differences configured to compensate for differences in the target tissue (e.g., different volumes of target tissue, types of tissue within the target tissue, etc.) and / or to avoid damage to certain non-target tissues proximate the target tissue (e.g., avoid adverse effects on nerves, blood vessels, and other potential non-target tissues). The differences in the first and second energy delivery settings can include one or more differences in the type of energy delivered (e.g., ultrasound energy versus electromagnetic, light, chemical, and / or other forms of energy), 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, modulation of energy delivery, control of energy delivery, focusing of energy delivery, and combinations thereof. In some embodiments, the system 10 delivers HIFU, focused ultrasound, and / or other ultrasound energy at a first frequency to a first volume of tissue and at a second frequency higher than the first frequency to a second volume of tissue smaller than the first volume of tissue.Higher frequencies may be used to selectively avoid adverse effects on non-target tissue near the target tissue, for example, nerves and / or blood vessels near the target tissue being ablated.

[0142] In some embodiments, all or a portion of the EDD 100 and / or another component of the system 10 are configured to be robotically manipulated by the algorithm 50, for example, where the algorithm 50 includes an AI algorithm configured to cause micro-movement of the EDM 150 during tissue treatment and / or diagnostic procedures. In some embodiments, the algorithm 50 is configured to move the EDM 150 (e.g., to prevent damage to the non-target tissue) based on an analysis of the anatomical location of non-target tissue (e.g., nerves) proximate to one or more tissue targets to be treated. For example, during ablation energy delivery, the algorithm 50 may be configured to fine-tune the position of the EDM 150 to avoid undesired tissue damage. In these embodiments, the identification of the non-target tissue (as recorded in the image data ID) can be performed by the clinician, automatically determined by the system 10 (e.g., via the AI-based algorithm 50), and / or identified via a combination of the algorithm 50 identification and clinician confirmation. In some embodiments, the system 10 is configured to stop energy delivery when an undesirable condition is detected by the algorithm 50, such as when the algorithm 50 determines that ablation energy is being delivered to non-target tissue and / or that non-target tissue is being adversely affected.

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

[0144] The system 10 may be configured to treat various patient conditions, such as one, two or more conditions selected from the group consisting of sleep apnea, the presence of tumors and / or cysts, ovarian conditions, cosmetic concerns, epilepsy, cognitive disorders, and / or other neurological disorders, pain, prostate problems (such as benign prostatic hyperplasia), cardiac conditions such as atrial fibrillation and / or other arrhythmias, conditions in which ablation of neural tissue provides a therapeutic benefit, 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 a medical procedure on the patient. As discussed above, system 10 may include one, two, three, or more energy delivery devices for use in the medical procedure, such as the illustrated EDD100, EDD100', and / or EDD100" (singly or collectively EDD100). Similarly, system 10 may include one, two, three, or more chronic energy delivery devices, such as the illustrated CEDD200, CEDD200', and / or CEDD200" (singly or collectively CEDD200), one, two, three, or more The force delivery devices may include the above force delivery devices, such as the illustrated FAD 300, FAD 300', and / or FAD 300" (singly or collectively FAD 300), and / or one, two, or more treatment devices 930. In some embodiments, system 10 includes multiple devices 100, 200, 300, and / or 930 that are used in a single clinical procedure to diagnose and / or treat a patient having an undesirable medical condition (such as a disease or disorder). In some embodiments, system 10 includes a patient The present invention also 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 a medical condition. 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. The one or more clinical procedures may include tissue stimulation (e.g., performed by the EDD 100 and / or the CEDD 200), tissue ablation (e.g., performed by the EDD 100), and tissue stimulation (e.g., performed by the EDD 100). The treatment may include one, two, or more tissue treatments selected from the group consisting of tissue debulking (e.g., performed by the EDD 100), tissue debulking (e.g., performed by the EDD 100, the CEDD 200, and / or the FAD 300), muscle strengthening (e.g., performed by the EDD 100, the CEDD 200, and / or the FAD 300), tissue scaffold formation (e.g., scaffold formation by one or more forces applied by the FAD 300 and / or the treatment device 930), treatments provided by the treatment device 930, and combinations thereof, each of which is described herein.

[0146] The system 10 may be configured to treat target tissue in various anatomical locations of a patient, such as where the target tissue includes 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 a portion of a hair shaft, hair root, hair follicle, hair bulb, and / or a segment of a blood vessel supplying blood to the hair bulb tissue), heart tissue, brain tissue, liver tissue, kidney tissue, pancreatic tissue, organ tissue, blood, and combinations thereof. In some embodiments, the target tissue comprises one, two, or more types of "airway tissue", such as one or more tissues (e.g., muscle, fat, and / or nerve tissue) selected from the group consisting of adenoid tissue (e.g., also referred to as pharyngeal tonsil tissue or nasopharyngeal tonsil tissue), cartilage tissue adjacent to the airway, epiglottis tissue, facial bones adjacent to the airway, genioglossus muscle tissue, geniohyoid tissue (e.g., the C1 branch of the geniohyoid muscle), glossopharyngeal tissue, sublingual tissue, lymphatic tissue adjacent to the airway, nasal septum tissue, tectoglossal tissue, pharyngeal wall tissue (e.g., lateral pharyngeal wall tissue), soft palate tissue, stylopharyngeal tissue, tensor veli palatini muscle tissue, tongue tissue (e.g., including adipose tissue and other fat cells of the tongue and the intrinsic or extrinsic muscles of the tongue), tonsil tissue (e.g., palatine tonsil and / or lingual tonsil tissue), nasal turbinate tissue (e.g., inferior turbinate tissue), vagus nerve tissue, and combinations thereof.

[0147] The EDD 100 and / or CEDD 200 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 of operation), for example, when one or more sensors (such as sensor-based functional elements 199, 299, 399, 599, and / or 999) of the system 10 provide patient and / or system information used to adjust the energy delivered by the device 100 / 200. Energy delivery by the EDM 150 / 250 may be adjusted in a closed-loop mode based on system 10 parameters and / or based on patient parameters (such as patient physiological parameters and / or patient environmental parameters, respectively, as described herein). Energy delivery by the EDM 150 / 250 may be adjusted based on the image data ID described herein, for example, to change the direction of energy delivery (e.g., due to detected patient movement and / or undesired EDM 150 / 250 movement) and / or to change one or more energy delivery settings (e.g., due to an ablation level or other treatment level determined by the algorithm 50 using the image data ID). In some embodiments, the image data ID is used to determine when a treatment (such as an ablation) is sufficient, for example, when the algorithm 50 analyzes ultrasound-based image data to confirm that a sufficient change in tissue characteristics has occurred. In some embodiments, the image data ID includes blood flow data (e.g., obtained via Doppler ultrasound), and energy delivery for treatment is based on levels and / or changes in blood flow including in the target tissue and / or non-target tissue.

[0148] The FAD 300 may be configured to apply a force in a closed-loop mode (i.e., a force-applying closed-loop mode and / or other closed-loop mode of operation), for example, when one or more sensors of the 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 being delivered by the FAD 300. The force applied by the FAD 300 may be adjusted in a closed-loop mode based on parameters of the system 10 and / or based on patient parameters (e.g., patient physiological parameters and / or patient environmental parameters, each of which are described herein). The force applied by the FAD 300 may be adjusted in a force adjustment procedure, as described herein. The force applied by the FAD 300 may be adjusted intermittently and / or continuously. The force applied by the FAD 300 may be adjusted based on the time of day and / or on patient physiological parameters (such as sleep parameters such as snoring). The force applied by the FAD 300 may be adjusted to compensate for patient respiration (e.g., as determined via a signal provided by a respiration sensor of the system 10). The force applied by the FAD 300 may be adjusted based on the image data ID described herein, for example, adjusting the applied force due to detected patient movement and / or undesired FAD 300 movement (as determined by the 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 (e.g., a sufficient level of force and / or a sufficient duration that the force has been applied), for example, when the algorithm 50 analyzes the ultrasound-based image data to determine that a sufficient change has occurred in tissue properties.

[0149] In some embodiments, energy delivery by one or more components of system 10 (e.g., devices 100, 200, and / or 300) is configured to be manually activated (e.g., "turned on" or simply capable of initiating energy and / or force delivery, and / or "turned off" or disabling energy and / or force delivery) by an operator, e.g., 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 delivery of therapeutic energy should commence. Alternatively or additionally, system 10 may be configured to be automatically activated. For example, system 10 may initiate or enable energy delivery (e.g., via CEDD 200) and / or force delivery (e.g., via FAD 300) at particular times of the day (e.g., at times during the night when the patient typically goes to sleep) and / or when evaluation of the patient's physiological parameters indicates that energy should be delivered (e.g., when system 10 determines, e.g., via sensors and algorithms 50, that the patient is asleep and / or snoring). Alternatively, system 10 may stop delivering energy and / or force automatically, for example, based on a particular time of day and / or based on a patient's physiological parameters (e.g., algorithm 50 determines that the patient is awake, has stopped snoring, and / or does not otherwise need to receive energy delivery). In some embodiments, system 10 is configured to deliver energy (e.g., via CEDD 200) and / or apply force (e.g., via FAD 300) during certain patient activities, such as while speaking and / or singing, to activate muscles used during speaking and / or singing.

[0150] System 10 may be operated in a closed loop mode, where modifications of energy delivery (e.g., modifications of frequency, amplitude, waveform, selection of energy delivery element delivering energy, and / or other energy delivery parameters) are implemented when undesirable energy delivery conditions are encountered, including, but not limited to, tissue temperature and / or temperature of a portion of a component of system 10 outside a desired temperature range (e.g., above a maximum temperature and / or below a minimum temperature), an amount of tissue ablated per unit time at an unacceptable rate, an amount of time delivering energy (e.g., to a single location) above a threshold, tissue condition and / or change in condition (e.g., elastic state) at an undesirable level, and combinations thereof.

[0151] The FAD 300 may be configured to operate in a closed-loop mode, such as where one or more sensors of the system 10 provide patient and / or system information that is used to adjust the FAD 300, e.g., adjust the force applied by the FAD 300 to the target tissue, as described herein. In some embodiments, the system 10 is configured to detect and / or predict undesirable sleep conditions, such as snoring and / or apnea events, and the system 10 is configured to adjust the FAD 300 (e.g., via the algorithm 50) to stop, limit, and / or prevent the undesirable sleep conditions. As described above, the FAD 300 may include an EDM 350, which may be configured to operate in a closed-loop mode of energy delivery, similar to that described above with reference to the EDM 150 and the EDM 250.

[0152] In some embodiments, energy delivery by the EDD 100 and / or CEDD 200 while performing the tissue reduction procedure is provided in a closed loop mode based on measurement (e.g., by one, two, or more sensors of the system 10) of a parameter selected from the group consisting of temperature, such as tissue temperature and / or temperature of a portion of the components of the system 10 (such as a portion of the EDD 100 and / or CEDD 200), patient movement and / or patient position (such as when the source and / or direction of energy delivery is changed to compensate for patient movement), patient physiological parameters, patient environmental parameters, parameters of the system 10, and combinations thereof. In some embodiments, energy delivery by the EDD 100 and / or CEDD 200 is delivered in a closed loop mode based on tissue ablation analysis, as described herein. For example, the system 10 can be configured to stop energy delivery when a sufficient level of tissue ablation has been achieved (such as recognized by the algorithm 50, e.g., by using image data ID collected by one or more components of the system 10, such as the EDM 150 and / or EDM 250 described herein).

[0153] In some embodiments, energy delivery by the EDD100 and / or CEDD200 while performing the tissue augmentation procedure is provided in a closed loop mode based on measurement (e.g., by one, two or more sensors of the system 10) of parameters selected from the group consisting of temperature, such as tissue temperature and / or temperature of a portion of a component 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 position during sleep, and / or other sleep parameters described herein), parameters of the system 10, and combinations thereof.

[0154] The EDD 100 may be configured to both image tissue and perform tissue reduction or other tissue treatment procedures (such as tissue treatment procedures performed on at least a portion of the imaged tissue) as described herein. Image data ID generated during imaging may be used by an operator (e.g., manually) and / or automatically by the system 10 (e.g., via the algorithm 50) to distinguish between target tissue to be treated and non-target tissue to avoid adverse effects (e.g., avoid delivery of sufficient energy to cause necrosis or other volumetric reduction effects). For example, target tissue to undergo tissue reduction procedures may include adipose tissue (such as adipose tissue of the tongue or other airway tissue), and non-target tissue to avoid being damaged may include vascular tissue, nervous tissue, and / or muscle tissue (such as non-target tissue adjacent to the adipose tissue being reduced and / or otherwise treated). The image data ID is used to generate a treatment plan (e.g., by the system 10 via the AI-based or other type of algorithm 50) that delivers a pattern of energy (such as relatively short bursts of ultrasound energy) that liquefies fat cells in the target tissue while avoiding damage to adjacent non-target tissue. In some embodiments, both adipose tissue and a small portion of muscle tissue are treated (e.g., causing coagulative necrosis of muscle tissue), for example, where additional treatment to muscle tissue enhances the therapeutic effect on a patient (e.g., a sleep apnea patient). In some embodiments, the non-target tissue includes vascular tissue, neural tissue, and / or mucosal tissue (e.g., mucosal tissue of the airways), and system 10 is configured to analyze the image data ID to generate a treatment plan that ablates the intended target tissue (e.g., adipose tissue and / or muscle tissue) while avoiding damage to these types of non-target tissue.

[0155] The EDM 150 of the EDD 100 may be configured to be placed at a location L100 accessed through a patient's mouth (e.g., as shown in FIG. 18B ) and / or nose (e.g., as shown in FIGS. 13 and 19 ). For example, the EDM 150 (including an array of ultrasound transducers, etc.) may be advanced through the patient's mouth and / or nostrils so that tissue treatment (e.g., ablation and / or stimulation treatment) may be performed on the patient's tongue, soft palate, tonsils, airway musculature, and / or other airway tissue. Alternatively or additionally, the EDM 150 may be positioned on the patient's skin, e.g., when positioned on skin located under the patient's chin (e.g., as shown in FIG. 12 ), to deliver treatment energy to tongue and / or genioglossus tissue (e.g., without the need to hold the patient's mouth open during the procedure).

[0156] In some embodiments, the system 10 is configured to perform a medical procedure to treat sleep apnea in a patient, such as when the target tissue includes airway tissue as defined herein. In these embodiments, the target tissue may be treated with a tissue reduction procedure (e.g., a procedure in which airway tissue is ablated using the EDD 100 and / or the CEDD 200), a tissue augmentation procedure (e.g., a procedure in which airway tissue is stimulated using the EDD 100 and / or the CEDD 200), and / or a procedure in which a force is applied to the tissue (e.g., using the FAD 300). In some embodiments, at least two of the EDD 100, the CEDD 200, or the FAD 300 are used to treat a patient with sleep apnea in a single clinical procedure or multiple clinical procedures. In some embodiments, at least one EDD 100, at least one CEDD 200, and at least one FAD 300 are used to treat a patient with sleep apnea in a single clinical procedure or multiple clinical procedures.

[0157] As described herein, the system 10 may be configured to perform a series of clinical procedures on a patient, such as a sleep apnea patient. In some embodiments, the system 10 is configured to perform a first procedure to reduce at least the volume of tonsillar tissue (such as by ablation or other tissue reduction procedure using the EDD 100 described herein) and then perform a second procedure (e.g., subsequent to the first procedure) in which muscle strengthening is performed (such as muscle strengthening performed by delivery of stimulation energy or 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 expansion procedure is performed, and then a second procedure (e.g., subsequent to the first procedure) in which the system 10 is used to ablate airway tissue (e.g., tongue, tonsils, and / or other airway tissue is ablated using the EDD 100), stimulate airway tissue (e.g., via the CEDD 200), and / or apply force to 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) to reduce a volume of at least the patient's tongue, and then a second procedure (e.g., subsequent to the first procedure) in which a force is applied to at least the patient's tongue (e.g., via the FAD 300). In some embodiments, the system 10 is configured to perform a first treatment to reduce the volume of airway tissue (e.g., reducing the volume of the tongue, tonsils, and / or other airway tissue using the EDD 100), then a second treatment (e.g., following the first treatment) in which tissue in the upper airway is tensioned or otherwise augmented (e.g., tensioning or otherwise augmenting upper airway muscles associated with the upper jaw, performed using the EDD 100), and then a third treatment (e.g., following the first treatment and / or the second treatment) in which stimulation energy is delivered and / or force is applied to the airway tissue (e.g., via the CEDD 200 and / or the FAD 300, respectively).In some embodiments, the system 10 is configured to perform a first procedure in which at least the volume of tonsillar tissue is reduced (e.g., by reducing the volume by ablation or other tissue reduction procedure using the EDD 100 described herein), and then perform a second procedure (e.g., subsequent to the first procedure) in which a force is applied to the airway tissue (e.g., via the FAD 300).

[0158] In some embodiments, the system 10 is configured to treat a patient with sleep apnea using a treatment device 930, such as a CPAP and / or a treatment device including an oral appliance. In these embodiments, the system 10 may utilize one or more of the EDD 100, CEDD 200, and / or FAD 300 to improve the effectiveness of the treatment device 930. For example, a patient using a CPAP at a first level (e.g., a first pressure level or airflow level) may undergo treatment (e.g., airway tissue ablation or other procedure described herein) using the system 10, after which the patient may avoid using a CPAP (e.g., further avoiding significant side effects of sleep apnea) or may use their CPAP at a second level reduced from the first level (e.g., a pressure level and / or airflow level reduced from the level used prior to treatment using the system 10). In some embodiments, the patient is taking one or more medications before treatment is performed by the system 10, and the patient's use of the medications is reduced or avoided after one or more treatments are performed using the system 10 as described herein.

[0159] The EDD 100 may be used to perform a tissue reduction procedure on a patient's airway tissue, such as tonsil tissue, of a patient (such as a sleep apnea patient) via energy (such as HIFU or other ultrasound energy) delivered by the EDM 150. In some embodiments, the system 10 is configured to reduce a significant portion of the tonsil tissue volume, such as by removing at least 50% of the pre-treatment tonsil volume, but not more than 90 or 95% of the pre-treatment volume. In other embodiments, the system 10 is used to reduce the tonsil volume while leaving at least 20%, 30%, 40%, 50%, and / or 80% of the pre-treatment tonsil volume while providing an improvement in the patient's condition (e.g., improvement in sleep apnea that may occur due to shrinkage of tonsil tissue over time, as described herein). In these embodiments, the actual reduction in tonsil volume may occur over time, such as over a period of at least one day, at least one week, and / or up to one month. In some embodiments, all of the treated (e.g., reduced) tissue includes the sub-surface tissue of the tonsil, in other words, the superficial tissue of the tonsil is left untreated and treatment (e.g., ablation and / or liquefaction) of the sub-surface tissue results in an overall reduction in the volume of the tonsil. In these embodiments, the EDD 100 may include cooling elements (e.g., the functional element 199 and / or the spacer 251 include cooling elements) to allow ablation of the sub-surface tissue while leaving the superficial tissue unaffected (e.g., cooled before, during, and / or after delivery of energy). In some embodiments, the tonsil is treated using an EDM 150 that includes a capture portion, and the tonsil is drawn and / or positioned within the capture portion (e.g., as described with reference to Figures 9, 10, and / or 11 herein). In some embodiments, a vacuum (e.g., provided by the console 500 and / or the functional element 199 of the EDD 100) is applied to the capture portion of the EDM 150 to draw the tissue to be treated into the capture portion. In some embodiments, the target tissue to be treated includes tonsil tissue, which is drawn (such as via vacuum) into the capturing portion of the EDM 150, and the tissue moves to separate the tonsil tissue from the muscle tissue.In other embodiments, the target tissue, including tonsillar tissue, is left in place (e.g., not pulled away from the non-target tissue) and the non-target tissue (such as muscle tissue adjacent to the target tonsillar tissue) is avoided from ablation due to the precision of the energy delivery (e.g., delivery of HIFU is performed while simultaneously imaging the target and non-target tissue).

[0160] In some embodiments, the EDD 100 is configured to reduce the volume of airway tissue located in close proximity to muscle tissue that will not be adversely affected (such as tonsillar tissue undergoing volume reduction that is located in front of muscle tissue that should not be ablated). In these embodiments, the EDD 100 may include an array of ultrasound transducers (such as CMUT and / or piezoelectric transducers) that deliver ultrasound energy (such as plane wave ultrasound energy) at a target frequency (such as about 6 MHz) configured to ablate a particular thickness of tissue (such as a thickness of 8-10 mm) while avoiding adverse effects on deeper tissue. In some embodiments, the target tissue has a particular thickness and the non-target tissue is located behind the target tissue. In these embodiments, the EDD 100 may be configured to ablate an inner portion of the thickness of the target tissue (such as 80% or less of the total thickness), for example, to avoid adverse effects on non-target tissue (such as muscle tissue and / or nerve tissue) underlying the target tissue being treated (e.g., reduced in volume). In some embodiments, the EDD 100 is configured to ablate target tissue (such as tonsillar tissue) while avoiding damage to non-target tissue (such as the muscle bed beneath the tonsil) using image data ID (such as real-time image data) collected by the EDD 100. In these embodiments, the EDD 100 may include an array of ultrasound transducers (such as CMUT and / or piezoelectric transducers) that deliver focused ultrasound energy (such as HIFU) to the target tissue while avoiding undesirable temperature rise in the non-target tissue (e.g., using geometric information in the image data ID and / or tissue temperature information in the image data ID).

[0161] The EDD 100 may be used by an operator to reduce the volume of adipose tissue as described herein, for example, adipose tissue proximate to a patient's airway that contributes to the patient's sleep apnea. For example, adipose tissue in the tongue, tonsils, and / or luminal walls of the airway may be reduced by energy delivered via the EDM 150. The adipose tissue treated may include fat behind the tongue, fat in the walls of the patient's airway (such as along the lateral pharyngeal wall), and / or fat in the soft palate. In some embodiments, the energy delivered by the EDM 150 (such as ultrasonic energy) may be configured to liquefy adipose tissue as described herein, for example, by delivering the energy in a manner that avoids ablation of tissue (e.g., avoiding use of high temperatures for significant periods of time, such as by avoiding exposure to temperatures above 43° C. for extended periods of time, or above 60° C.).

[0162] The system 10 may be configured to modify the shape of a segment of a patient's nasal airway, such as through delivery of energy by the EDD 100 and / or CEDD 200. For example, the EDM 150 of the EDD 100 may be positioned at a location within and / or near the surface of the nasal tissue to perform a therapeutic procedure or the like on the nasal tissue (e.g., as described with reference to FIGS. 13 and 19 herein). The energy delivered by the EDM 150 (e.g., HIFU and / or other ultrasonic energy) may be delivered to form holes in the nasal septum, soften the nasal septum, or both, such that the nasal septum may be reshaped (e.g., over time) to increase the volume of the patient's airway proximate the nasal septum. In some embodiments, the EDM 150 is configured to perform tissue modifications selected from the group consisting of forming one or more holes in the nasal septum, thinning or reducing the volume of cartilage proximate the nasal passage, softening and / or otherwise reducing the stiffness of bone and / or cartilage proximate the nasal passage, and combinations thereof. In some embodiments, the EDM 150 is configured to deliver energy to form holes in and / or soften the nasal septum, e.g., to reshape and / or otherwise facilitate reshaping (herein "reshape") the nasal passages to improve sleep apnea symptoms. In some embodiments, after the therapeutic energy is delivered by the EDM 150, a treatment 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 treated portion of the airway to reshape the portion and maintain the new shape. In some embodiments, after the therapeutic energy is delivered by the EDM 150, a treatment device 930 including one or more stents (such as temporary stents) is placed in and / or near the treated segment of the airway to reshape the portion and maintain the new shape. In these embodiments, the stent-based treatment device 930 may be removed after a period of three months, one month, and / or one week or less.In some embodiments, energy delivery is performed by a pair of devices positioned on either side of the nasal septum, for example, where an EDM 150a is positioned on one side of the septum and a mirror 155 is positioned on the other side of the septum (e.g., as described with reference to FIG. 19 herein), or where a first EDM 150a and a second EDM 150b are positioned on either side of the septum, either or both of which can deliver energy (e.g., ultrasonic energy) to the septum.

[0163] In some embodiments, at least the FAD 300 is used to treat a patient with sleep apnea (e.g., when the EDD 100 and / or the CEDD 200 are also used to treat the patient). The FAD 300 may be positioned proximate to airway tissue such that the FAA 360 can scaffold the airway (e.g., move tissue out of the airway) and / or the FAA 360 can tone, strengthen, and / or otherwise augment airway tissue (e.g., airway musculature). In some embodiments, the FAD 300 is attached to the pterygoid uncus such that when activated, the FAA 360 can rotate to tone airway musculature (e.g., treat soft palate-based sleep apnea). The FAA 360 may be positioned to apply force to tissue of the tensor veli palatini, for example, to move the tissue back and forth. In some embodiments, the FAA 360 is positioned to apply force to tissue in one, two, three, or more directions. In some embodiments, the FAA 360 is positioned to apply a force to one, two, three, or more tissues selected from the group consisting of tensor veli palatini muscle tissue, levator veli palatini muscle tissue, genioglossus muscle tissue (e.g., to pull the tongue forward), internal nasal valve tissue, tongue tissue (e.g., to cause contraction when force is applied), and combinations thereof.

[0164] The system 10 may be configured to perform transfacial energy delivery through the patient's skin surface to tissue beneath the skin, for example, via delivery of energy by the EDD 100 and / or CEDD 200, as described with reference to FIG. 14 herein. In these embodiments, the system 10 may be configured to deliver energy to the patient's facial muscles, fat, and / or bone. In some embodiments, the EDM 150 of the EDD 100 delivers energy to reduce the volume of bone tissue and / or at least weaken bone tissue, for example, for a sleep apnea patient following a distraction osteogenesis maxillary expansion (DOME) procedure.

[0165] System 10 may be configured to perform therapy on a patient (e.g., a sleep apnea patient), including the execution of multiple successive therapy plans, e.g., a series of therapy plans, each of which may use one, two or more of the components of system 10 (e.g., one, two or more of devices 100, 200, and / or 300) used to perform one or more diagnostic procedures and / or one or more therapeutic procedures. In some embodiments, system 10 is configured to execute a therapy plan as described with reference to FIG. 3 herein. The execution of an "initial therapy plan" performed using system 10 may be configured based on the patient's current physiological state (e.g., current sleep apnea symptoms) and any previous therapy performed (e.g., using system 10 or other methods). Each "subsequent therapy plan" may also be based on the current physiological state and any previously performed therapy.

[0166] In some embodiments, the initial treatment plan may include using 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, the initial treatment plan may include one, two, or more of tissue resection procedures performed on soft tissues, such as the adenoids, palatine tonsils, lingual tonsils, inferior turbinates, and / or tongue fatty tissue, tissue modification procedures performed on hard tissues, such as an anterior septum formation procedure performed using EDD100 or other methods, and / or a distraction procedure performed on the maxilla (such as the piriform border 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 a uvulopalatopharyngoplasty (UPPP) performed on upper airway tissues (such as the tensor veli palatini, levator palatini, palatopharyngeal muscles, palatoglossus muscles, geniohyoid, and / or geniohyoid tissue).

[0167] The second treatment plan (such as a plan determined after the first treatment plan described immediately above is performed) may include a treatment plan that includes a tissue strengthening procedure (such as one performed using the device 100 / 200 / 300). For example, the second treatment plan may include a muscle strengthening procedure, such as a nerve stimulation procedure (e.g., via energy delivery from the CEDD 200), in which the trigeminal nerve (cranial nerve 5, CN V), the hypoglossal nerve (cranial nerve 12, CN XII), and / or the vagus nerve (cranial nerve 10, CN X) are stimulated (unilaterally and / or bilaterally, such as via an intraoral and / or cervical approach). Alternatively or additionally, the muscle strengthening procedure of the second treatment plan may be performed by applying force to one or more muscles (such as muscles associated with the nerves described immediately above), for example, via one or more forces applied by the FAD 300, as described herein.

[0168] A third treatment plan (such as one determined after the second treatment plan just described is performed) may include tissue stabilization and / or expansion procedures. In some embodiments, the FAD 300 or treatment device 930 (including, for example, 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 includes placing the FAD 300 in and / or near the airway tissue to form an airway scaffold, strengthen and / or augment the airway musculature, and / or provide another therapeutic benefit, etc. In some embodiments, all or a portion of the implanted FAD 300 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 a portion of the implanted FAD 300 is configured to be resorbed, e.g., 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 immediately above are administered in any order, hi some embodiments, one of the first, second, or third treatment plans is not administered to the patient.

[0170] In some embodiments, the system 10 includes a functional element 999, which includes a sensor configured to be implanted in the patient and detect the patient's respiration, such as a sensor located adjacent to the lungs, in the external and internal intercostal muscles (e.g., between the external and internal intercostal muscles), and / or other locations under the patient's skin. In some embodiments, the functional element 999 includes a sensor located external to the patient, such as on or adjacent to the patient's skin, and configured to detect the patient's respiration. In these embodiments, the CEDD 200 and / or the FAD 300 may be configured in a closed-loop mode and 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 (such as to cause tongue protrusion).

[0171] In some embodiments, the EDD 100 and / or CEDD 200 are configured to deliver ultrasonic energy to interact with a pharmaceutical agent (such as an active agent 920) delivered to the patient, as described herein. The interaction may include release (such as from a carrier) and / or other activation of the drug, and / or the interaction may include enhancement of the effect of the drug. In some embodiments, the drug includes one or more visualizeable components (such as a radiolucent component and / or an ultrasound reflective component) that the system 10 uses to locate the drug and then precisely deliver ultrasonic energy to cause the interaction.

[0172] In some embodiments, the EDD 100 and / or CEDD 200 are configured to deliver energy to treat a cyst in a patient. In some embodiments, energy is delivered to a relatively small cyst, for example to image and / or treat the cyst (such as by removing the entire cyst or at least reducing the volume of the cyst). In some embodiments, a larger cyst is treated, fluid from the cyst is drained (e.g., via treatment device 930), and then energy is delivered to image and / or treat the cyst.

[0173] In some embodiments, the FAD 300 includes at least a portion (such as the FAA 360) that is implanted into a patient at an implant location (such as the L300 described herein) that is selected to treat a subglottic stenosis (such as a stenosis occurring as a complication of a previous intubation of the patient). In these embodiments, the FAA 360 can be anchored to laryngeal cartilage such that one or more actuators of the FAA 360 apply a force to the stenosis (e.g., scaffolding the stenosis).

[0174] The FAD 300 may include at least a portion (e.g., FAA 360) that is implanted within a patient at an implant location (e.g., L 300 described herein) selected to treat pelvic organ prolapse and / or urinary incontinence. One or more actuators of the FAA 360 may be configured to apply a force to one or more tissue locations (e.g., one or more volumes of target tissue) to treat pelvic organ prolapse and / or treat urinary incontinence. The FAA 360 may be configured (e.g., resiliently biased) in a normally deployed state (e.g., energy is minimal or not consumed during application of force to tissue, and energy is applied to transition to a non-deployed state). Alternatively or additionally, the FAA 360 may be configured (e.g., resiliently biased) in a normally non-deployed state (e.g., energy is applied to the FAA 360 to transition to a deployed state). In some embodiments, one or more actuators of the FAA 360 may be positioned to apply a force to tissue (e.g., urethral tissue) to prevent undesired leakage of urine. In these embodiments, the FAA 360 may be configured (e.g., resiliently biased or otherwise configured) normally in a deployed state (e.g., actuators extended to apply force to tissue), and the patient may (via the externally positioned user interface 390 and / or other user interfaces described herein) transition the FAA 360 to a non-deployed state (e.g., retract one or more actuators of the FAA 360 to cease applying force to tissue) to enable urination.

[0175] The system 10 may be configured to provide therapy to the patient's lungs, for example, to improve airflow through one or both of the patient's lungs. In some embodiments, the 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, the PEEP may be measured via the EDD 100 and / or an imaging device 910 including an ultrasound imaging device. For example, the EDM 150 may include an array of ultrasound transducers configured to generate image data ID from which the PEEP measurement may be determined (e.g., via the algorithm 50). The PEEP measurement may be used to generate a treatment plan, as defined herein, for example, to set and / or change (herein "set") one or more energy delivery settings of the EDM 150, for example, one or more energy delivery settings associated with a tissue reduction procedure (such as a tissue ablation procedure) and / or a tissue augmentation procedure (such as a tissue stimulation procedure). Alternatively or additionally, the PEEP measurements may be used to prognose treatment by the system 10 (e.g., the algorithm 50 may predict the outcome of a treatment before, during, and / or after the treatment is completed).

[0176] Referring now to Figure 2, a flow chart of a method of providing therapy in a closed loop configuration consistent with the inventive concepts is shown. Method 2000 includes a number of steps that may be executed automatically and / or semi-automatically (herein "automatically") to deliver energy (such as stimulation energy) and / or provide therapy in a form that varies based on one or more measured patient physiological parameters, patient environmental parameters, and / or other parameters. Method 2000 of Figure 2 is described using system 10 and its components of the inventive concepts.

[0177] In step 2010, the EDD 100 and / or CEDD 200 (singly or collectively referred to herein as "device 100 / 200") are placed in proximity to a 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., stimulate and / or treat the target tissue). The device 100 / 200 may be implanted within the patient's tissue and / or may be placed on a tissue surface (such as the patient's skin and / or the lining of the patient's airway). In step 2010, the device 100 / 200 may be delivering energy to the patient or may be in a "standby" mode where no energy is being delivered.

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

[0179] In step 2030, one or more patient parameters recorded by the system 10 may be analyzed (e.g., by the algorithm 50), such as to determine whether a threshold has been exceeded. The threshold may include a 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 a level of one, two, or more patient parameters that correlates to an ineffective or undesirable level of stimulation or other energy currently being delivered by the device 100 / 200 (such as an energy delivery level that should be altered or discontinued).

[0180] If the threshold is not exceeded, method 2000 continues monitoring the patient parameters (eg, does not change the current energy delivery or other treatment settings) in step 2020. 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 are determined, for example, automatically by system 10 and / or manually by an operator of system 10 (e.g., the patient and / or the patient's medical professional). In some embodiments, the modified set of treatment settings includes ceasing delivery of energy by device 100 / 200 (e.g., turning off stimulation). In some embodiments, the new modified 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., for the current patient and / or other patient populations) collected using system 10. For example, algorithm 50 (e.g., an AI algorithm) may determine a new set of treatment settings based on parameters selected from the group consisting of current patient parameters, previous patient parameters (e.g., parameters from the same patient and / or one, two, or more different patients treated using system 10), changes in patient parameters (e.g., magnitude of change in patient parameters), current energy delivery settings, previous energy delivery settings (e.g., 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 (e.g., energy is delivered at those settings) and method 2000 continues monitoring the patient parameters in step 2020, with method 2000 periodically repeating.

[0182] In some embodiments, in method 2000, delivery of energy by device 100 / 200 can be stopped at any time (e.g., by the patient via a control on the user interface of system 10 and / or by system 10, such as when a system parameter or patient parameter exceeds a threshold value).

[0183] In some embodiments, the system 10 is configured to change therapy settings, including non-energy delivery settings, if a threshold is exceeded as determined in step 2030, for example by performing an action selected from the following group: waking the patient (e.g., via an audio or tactile alert provided by functional elements 999 and / or consumer devices 940, including mobile phones, tablets, computers, alarm clocks, bed shakers, and / or other alarm functional devices), changing the patient's position (e.g., via an adjustable bed and / or other robotic patient manipulators), changing the patient environment (adjusting shades, 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, the algorithm 50 is configured to analyze sounds (such as snoring and / or other breathing sounds) produced by the patient while sleeping via one or more sensors of the system 10. In these embodiments, the algorithm 50 is configured to distinguish the patient's sounds (such as snoring) from other sounds in the room that may also be recorded by the sensors (e.g., sounds from humans or other animals in the room, or sounds from a television), e.g., the comparison to the threshold performed in step 2030 may be based on the snore signal received only from the patient using the system 10. In some embodiments, the system 10 includes two or more sensors used to record sounds made by the patient, and the algorithm 50 distinguishes between particular patient sounds based on the location of each sensor, the timing of the received signal (e.g., if the same snoring or other audio 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 the 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 devices capable of recording audio. In some embodiments, the algorithm 50 is configured to perform various signal processing techniques on the recordings, such as noise canceling.

[0185] In some embodiments, the system 10 includes a set of multiple similar components (such as multiple devices 100 / 200 and / or multiple functional elements 999 configured to record sleep sounds), and the system 10 is configured for use in treating multiple patients (e.g., at least while asleep) residing in a room (such as a bedroom, hospital room, and / or barracks). For example, each patient of the multiple patients may have a device 100 / 200 implanted therein or otherwise arranged to deliver energy (such as stimulation energy) while asleep. In these embodiments, the algorithm 50 may be configured to differentiate patient parameters (such as sleep sounds) based on the patient to which the parameters apply, for example, to differentiate sounds based on the use of multiple sensors as described above.

[0186] Referring now to Figure 3, there is shown a flow chart of a method for treating a patient consistent with the inventive concepts. Method 3000 includes multiple steps of treating a patient, including, for example, performing a diagnostic procedure and / or a therapeutic treatment. Method 3000 of Figure 3 will be described using system 10 and its components of the inventive concepts.

[0187] In step 3010, a patient diagnostic procedure is performed, e.g., a diagnostic procedure performed with one or more devices of system 10 and 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 (e.g., an operator of system 10) and / or via an algorithm 50 of system 10, e.g., an AI algorithm that utilizes the diagnostic data collected in step 3010. The diagnostic procedure may include obtaining a medical history of the patient. The diagnostic data may include data collected through performance of a procedure selected from the group consisting of a polysomnography procedure and a procedure for determining weight and / or body mass index.

[0188] In step 3020, a first patient treatment procedure is performed, the first treatment being part of the treatment plan determined in step 3010. The first patient treatment procedure may include a tissue reduction procedure and / or a tissue augmentation procedure, each as described herein. The first patient treatment procedure may include one or more treatments performed using the system 10 or other methods, such as a nasal procedure (e.g., an adenoidectomy, turbinate reduction, septoplasty, and / or a DOME procedure), a soft palate procedure (such as a tonsillectomy or tonsil volume reduction, pharyngoplasty, tissue stimulation via the EDD 100 and / or the CEDD 200, and / or implantation of an implant, such as a treatment device 930 including a soft palate implant and / or a FAD 300, each as described herein), and / or a tongue procedure (such as a lingual tonsillectomy, advancement of the genioglossus or other tongue muscles, tissue stimulation via the EDD 100 and / or the CEDD 200, a force delivery procedure via the FAD 300, etc.).

[0189] In step 3030, an optional step may be performed to perform 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 (e.g., based on additional diagnostic data collected in step 3030, e.g., diagnostic data based on the treatment performed in step 3020).

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

[0191] In some embodiments, the method 3000 of FIG. 3 is performed on a sleep apnea patient and includes performing at least two, at least three, or all four of the following tissue treatment procedures: reducing the volume of tonsil tissue, reducing the volume of tongue tissue, tightening, strengthening, and / or toning the muscles of the airway, and stimulating one or more nerves and / or muscles of the patient's airway. In some embodiments, the patient's adenoid tissue is treated. The tissue treatment procedures may be performed using one, two, or more of each of devices 100, 200, and / or 300.

[0192] In some embodiments, method 3000 includes a third, fourth, etc. additional treatment, for example the additional treatment including implantation and subsequent use of a CEDD200 (e.g., for stimulation of airway tissue) and / or a FAD300 (e.g., for application of force to airway tissue), each as described herein.

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

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

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

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

[0197] In some embodiments, the second treatment of step 3040 includes a DOME treatment (such as a DOME treatment performed using the EDD 100 of system 10). In these embodiments, the third treatment may be performed, such as a treatment that includes implantation and subsequent use of a CEDD 200 (e.g., for stimulation of airway tissue) and / or a FAD 300 (e.g., for application of force to airway tissue), each as described herein.

[0198] In some embodiments, the first treatment of step 3020 includes at least a volume reduction of tonsillar tissue, and the second treatment of step 3040 includes stimulation of airway tissue (eg, using an implanted CEDD 200).

[0199] In some embodiments, after the patient has been treated with CPAP, the patient undergoes administration of a first therapeutic treatment in step 3020, and a subsequent therapeutic treatment (such as a second therapeutic treatment in step 3040) involves the patient avoiding the need for CPAP or using CPAP at a lower pressure and / or rate level than the patient used prior to administration of the initial therapeutic treatment (e.g., the first or other previous therapeutic treatment). In other words, CPAP is avoided or reduced due to airway improvement and / or other therapeutic benefit provided in the previous therapeutic treatment. In some embodiments, the use of CEDD 200 (e.g., to stimulate airway tissue) and / or FAD 300 (e.g., to apply a scaffolding force to airway tissue) results in the patient avoiding and / or reducing the level of CPAP.

[0200] Referring now to FIG. 4, a side cross-sectional anatomical view of a chronic energy delivery device implanted in a patient for stimulating nerves is shown, consistent with the concepts of the present invention. The CEDD 200 of FIG. 4 is of similar construction and arrangement to the CEDD 200 described with reference to FIG. 1 and / or this specification, and may include similar components. The CEDD 200 of FIG. 4 includes an implantable portion 2100 implanted in the patient and an external portion 2500 disposed (e.g., removably disposed) on the patient's skin proximate to the implantation location of the implantable portion 2100. 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 are shown disposed on the wrap 2110). The implantable portion 2100 further includes one, two, or more ultrasound transducers UST2199 (three are shown disposed on the wrap 2110). The 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 with the UST2199 integrated therewith. The UST2199 includes an array of multiple piezoelectric and / or other ultrasound transducers, which are positioned to allow reception of ultrasound energy from multiple directions (such as an omnidirectional arrangement of transducers).

[0201] The external portion 2500 includes a housing, or housing 2501, that encloses an energy delivery module EDM 2510. The EDM 2510 may be of similar construction and arrangement as the EDM 250 described herein. The EDM 2510 may include an array of one, two, or more ultrasonic transducers UST2599 (26 elements shown in two arrays of 13 elements) configured to deliver ultrasonic energy to the UST2199 of the implantable 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 therapy delivery, the EDM 2510 delivers ultrasonic energy to the UST 2199, which converts it to electrical energy. The electrode 2120 receives the electrical energy from the UST 2199 via the conduit 2121 shown, which the electrode 2120 delivers (e.g., via an applied voltage) to the target tissue (e.g., nerve N1 as shown). In this configuration, the waveform of the electrical energy delivered to the target tissue depends on the energy delivery waveform provided by the EDM 2510. In some embodiments, the implantable portion 2100 may include a controller (e.g., not shown, but of similar structure and arrangement to the controller 210 of the CEDD 200) to use the electrical energy generated by the UST 2199 to generate one or more different stimulation waveforms (e.g., stimulation waveforms independent of the energy delivery pattern provided by the external portion 2500 to the implantable portion 2100) for delivery to the target tissue by the electrode 2120.

[0203] In some embodiments, the external portion 2500 includes a spacer 251 as shown, e.g., a spacer 251 described herein. In some embodiments, the implantable portion 2100 includes at least two separate implantable portions, e.g., the implantable portion 2100 as shown (positioned proximate to nerve N1) and a second implantable portion 2100', not shown, positioned proximate to a different segment of nerve N1 or positioned proximate to a different nerve (e.g., a different nerve performing a similar role or function) as described with reference to FIG. 5 herein.

[0204] In some embodiments, the CEDD 200 of FIG. 4 is configured to operate in a closed-loop mode, as described with reference to FIGS. 1, 2, and elsewhere herein. For example, the controller 210 (e.g., including the algorithm 50) may regulate energy delivery in a closed-loop mode. In some embodiments, at least a portion of the controller 210 is included in the implantable portion 2100, such that the energy delivered by the implantable portion 2100 may be regulated in a closed-loop mode without control signals being transmitted from an external component of the system 10. The controller 210 may include a battery, a capacitor, and / or other energy storage element such that electrical energy may be stored by the implantable portion 2100. In some embodiments, energy is transferred to the implanted energy storage element via transmission of electrical energy (e.g., via inductive coupling, capacitive coupling, delivery of radio frequency energy, etc.) and / or transmission of ultrasonic energy (e.g., ultrasonic energy received by one or more ultrasonic transducers and converted to electrical energy, as described herein). The controller 210 may include a voltage controlled oscillator that controls the voltage of the electrostimulation energy delivered by the electrodes 2120.

[0205] Referring now to FIG. 5, a side cross-sectional anatomical view of a chronic energy delivery device implanted in a patient for stimulating nerves is shown, consistent with the concepts of the present invention. The CEDD 200 of FIG. 5 is of similar structure and arrangement to the CEDD 200 of FIG. 1 and / or described herein and may include similar components. The CEDD 200 of FIG. 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 (e.g., removably positioned) on the patient's skin proximate to the second implantable portion 2100b. The first implantable portion 2100a includes a wrap 2110 that is implanted to surround (e.g., partially surround as shown) the nerve N1. Alternatively, the wrap 2110 may simply be positioned near and along the nerve N1 (such as when the wrap 2110 includes a tubular structure, e.g., a flexible tubular structure including an array of ultrasound transducers). The first implantable portion 2100a further includes one, two, or more electrodes, i.e., electrodes 2120 (six are shown disposed on the wrap 2110). The second implantable portion 2100b includes one, two, or more ultrasound transducers UST2199, shown housed within a housing, i.e., housing 2101. The 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 with an integrated UST2199. The UST2199 is electrically connected to the electrodes 2120 via a conduit 2121 (e.g., one, two, or more wires). The UST2199 may include an array of multiple piezoelectric and / or other ultrasound transducers arranged to allow for receipt of ultrasound energy from multiple directions (such as an omnidirectional arrangement of transducers).

[0206] The outer portion 2500 of FIG. 5 is of similar construction and arrangement, and may include similar components, as the outer portion 2500 of FIG. 4 described above.

[0207] During therapy delivery, the EDM 2510 delivers ultrasonic energy to the UST 2199, which converts it to electrical energy. The electrode 2120 receives electrical energy from the UST 2199 via a conduit 2121, which the electrode 2120 delivers to the target tissue (such as nerve N1 as shown). In this configuration, the waveform of the electrical energy delivered to the target tissue depends on the energy delivery waveform provided by the EDM 2510. In some embodiments, the implantable portion 2100 may include a controller (e.g., not shown, but of similar structure and arrangement to the controller 210 of the CEDD 200) to use the electrical energy generated by the UST 2199 to generate one or more different stimulation waveforms (e.g., stimulation waveforms independent of the energy delivery pattern provided by the external portion 2500 to the implantable portion 2100) for delivery to the target tissue by the electrode 2120.

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

[0209] In some embodiments, the CEDD 200 of FIG. 5 is configured to operate in a closed-loop mode as described herein with reference to FIGS. 1, 2, and others. For example, the controller 210 (e.g., including the algorithm 50) may regulate the energy delivery in a closed-loop mode. In some embodiments, at least a portion of the controller 210 is included in the implantable portion 2100a and / or 2100b, such that the energy delivered by the implantable portion 2100a may be regulated in a closed-loop mode without a control signal transmitted from an external component of the system 10. The controller 210 may include a battery, a capacitor, and / or other energy storage element such that electrical energy may be stored by the implantable portion 2100. The controller 210 may include a voltage controlled oscillator to control the voltage of the electrical stimulation energy delivered by the electrodes 2120.

[0210] 6A-6B, side cross-sectional anatomical views of a force delivery device implanted in a patient for applying a force to tissue are shown consistent with the concepts of the present invention. The FAD 300 of FIGS. 6A-6B is of similar construction and arrangement, and may include similar components, as the FAD 300 described with reference to FIG. 1 and / or elsewhere herein. The FAD 300 of FIGS. 6A-6B is anchored to a first tissue location (such as bone B1 as shown) and applies a force to a second tissue location (e.g., a target tissue such as muscle M1 as shown). The FAD 300 includes a substrate 3110 having a first portion 3110a that is anchored to tissue using a fixation element 3111 (e.g., a bone anchor, suture, staple, etc.). The substrate 3110 includes a second portion 3110b that is configured to deflect to apply a force to the target tissue. In Figure 6A, the second portion 3110b is shown in an undeflected state, and in Figure 6B, the second portion 3110b is shown in a deflected state (e.g., angularly deflected as compared to the state in Figure 6A). As described herein, the FAD 300 may be configured to apply a force to a target tissue to alter a property of the tissue (e.g., to strengthen muscle tissue) and / or may apply a force to cause an increase in a cross-sectional area of ​​the airway.

[0211] The substrate 3110 may include an electromechanical assembly that is configured to change shape, such as when supplied with a voltage, a temperature change, and / or other drive signal. The substrate 3110 may include an electromechanical assembly that includes piezoelectric films (such as bimorph and / or unimorph), shape memory metals and / or shape memory polymers, and / or motors, gears, actuators, cams, and / or other components that may be remotely controlled to transition between a non-deployed state and a deployed (e.g., force-applying) state. In some embodiments, the substrate 3110 may include a Peltier element.

[0212] Referring now to FIG. 7, there is shown a partially transparent anatomical view of a force delivery device implanted in a patient for applying a force to tissue consistent with the concepts of the present invention. The FAD 300 of FIG. 7 is of similar construction and arrangement, and may include similar components, as the FAD 300 described herein with reference to FIG. 1 and / or elsewhere. The FAD 300 of FIG. 7 includes a substrate 3110 implanted in a patient's airway as shown, including a middle portion 3110d and end portions 3110c and 3110e. Either or both of portions 3110c and 3110e may be configured to apply a force (e.g., alone or in combination) to the opposing side of the airway, as shown in FIG. 7. The force may be applied by the FAD 300 to the tissue continuously and / or intermittently, at constant and / or varying levels of force. The force may be applied to strengthen adjacent muscles and / or to form a scaffold for the airway.

[0213]

[0031] Referring now to Figure 8, a cross-sectional anatomical view of an energy delivery device for delivering energy to tissue consistent with the concepts of the present invention is shown. The EDD 100 of Figure 8 is of similar construction and arrangement, and may include similar components, as the EDD 100 described herein with reference to Figure 1 and / or elsewhere. The EDD 100 of Figure 8 includes a housing 101 that surrounds an EDM 150 as shown. The EDM 150 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 shown) in the patient's tonsils (e.g., tonsils embedded in other tissue), while avoiding delivery of energy to tissue below and / or to the side of the tonsils (e.g., muscle tissue below and / or to the side of the tonsils).

[0214] 9, a side view of an energy delivery device is shown delivering energy to tissue captured by the device consistent with the concepts of the present invention. The EDD 100 of FIG. 9 is of similar construction and arrangement to the EDD 100 described herein with reference to FIG. 1 and / or others and may include similar components. The EDD 100 of FIG. 9 includes a housing 101 that includes a cup-shaped capturing portion 102 that is fluidly attached to a channel, shown as channel 103. The housing 101 may include a full (as shown) or partial circumferential geometry. The EDD 100 is configured to be operatively attached to a console 500 (not shown, but as described herein) via a cable 501 such that the console 500 can apply a vacuum via the cable 501 (such as a vacuum lumen of the cable 501) and the channel 103 to draw the tissue adjacent portion 102 into the portion 102 (tissue T1 as shown). The EDD 100 further includes an EDM 150, which may include an array of energy delivery elements (such as a curvilinear array of energy delivery elements as shown in FIG. 9 ). The EDM 150 may receive energy (such as electrical energy) from the console 500 via a cable 501 (e.g., via one or more wires of the cable 501) and then deliver energy (such as HIFU or other ultrasound energy) to tissue T1 captured within the portion 102. The tissue T1 may include tissue located within the patient's airway, such as tonsillar tissue and / or other tissue that comprises the patient's airway (e.g., and is causing a sleep apnea event in the patient).

[0215] 10, a perspective view of an energy delivery device is shown that delivers energy to tissue captured by the device consistent with the concepts of the present invention. The EDD 100 of FIG. 10 is of similar construction and arrangement to the EDD 100 described herein with reference to FIG. 1 and / or others, and may include similar components. The EDD 100 of FIG. 10 includes a housing 101, which includes a cone-shaped capturing portion 102 that is fluidly attached to a channel, shown as channel 103. The housing 101 may include a full (as shown) or partial circumferential geometry. In some embodiments, the capturing portion 102 includes a tubular capturing portion. The EDD 100 is configured to be operably attached to a console 500 (not shown, but as described herein) via a cable 501, such that the console 500 may apply a vacuum via the cable 501 (such as a vacuum lumen of the cable 501) and the channel 103 to draw the tissue adjacent portion 102 into the cone-shaped geometry of the portion 102. The EDD 100 further includes an EDM 150, which may include an array of energy delivery elements (e.g., a partial as shown, or a complete circumferential array of energy delivery elements). The EDM 150 may 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 captured within portion 102. In some embodiments, the EDM 150 includes a full or near full circumferential (e.g., greater than 270°) array of energy delivery elements such that energy (such as HIFU or other ultrasound energy) may be delivered to tissue captured within portion 102 from a full or near full circumferential set of energy delivery directions. The tissue captured within portion 102 may include tissue located within the patient's airway, such as tonsillar tissue and / or other airway tissue (e.g., tissue causing a sleep apnea event 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 now to FIG. 11, a perspective view of an energy delivery device is shown that delivers energy to tissue captured by the device in accordance with the concepts of the present invention. The EDD 100 of FIG. 11 is of similar construction and arrangement to the EDD 100 described herein with reference to FIG. 1 and / or elsewhere, and may include similar components. The EDD 100 of FIG. 11 includes a housing 101 that includes a cylindrical capture portion 102. The housing 101 may include a full (as shown) or partial circumferential geometry. The EDD 100 is configured to be operably attached to a console 500 (not shown, but as described herein) via a cable 501. The capture portion 102 may be slid over the tissue to be treated (such as the tonsils or other tissue). The EDD 100 further includes an EDM 150, which may include an array of energy delivery elements (e.g., a partial as shown, or a full circumferential array of energy delivery elements). The EDM 150 may receive energy (such as electrical energy) from the console 500 via the cable 501 (e.g., via one or more wires of the cable 501) and then deliver energy (such as HIFU or other ultrasound energy) to tissue captured within the portion 102. In some embodiments, the EDM 150 includes a full or near full (e.g., greater than 270°) array of energy delivery elements such that energy (such as HIFU or other ultrasound energy) may be delivered to the captured tissue from a full or near full set of energy delivery directions. Tissue captured within the portion 102 and subsequently treated by the EDM 150 may include tissue located within the patient's airway, such as tonsillar tissue and / or other airway tissue (e.g., tissue causing a sleep apnea event in the patient). Tissue drawn into the portion 102 may include tissue from one or more various anatomical locations, such as tissue that is part of an organ or other body tissue.

[0217] Referring now to FIG. 12, a side cross-sectional anatomical view of an energy delivery device positioned on the skin under a patient's chin and delivering energy to tongue tissue is shown consistent with the concepts of the present invention. The EDD 100 of FIG. 12 is of similar construction and arrangement to the EDD 100 described herein with reference to FIG. 1 and / or elsewhere and may include similar components. The EDD 100 of FIG. 12 includes an EDM 150 that may include an array of energy delivery elements configured to deliver energy to tissue. In some embodiments, the EDD 100 is configured to be positioned on the skin under the patient's chin at location L100 while delivering energy (such as HIFU and / or other ultrasonic energy) to the patient's tongue and / or other airway tissue of the patient. The EDM 150 may be configured to deliver energy to the tongue to reduce tongue volume and / or administer another tissue treatment as described herein. The EDM 150 may be configured to be operably attached to an energy source (e.g., attached to a console 500 via cable 501, both not shown but described in detail herein). In some embodiments, the EDM 150 may include an internal power source (such as a functional element 199 that includes a battery and / or other power components) and / or a controller (such as the controller 110 described herein) for providing a drive signal to the EDM 150. In some embodiments, a tool 950 including a stabilizing device is included, such as for attaching the EDD 100 to a patient during energy delivery. In some embodiments, the EDD 100 includes a spacer disposed between the EDM 150 and the patient's skin, such as the spacer 151 described herein.

[0218] In some embodiments, the EDD 100 of FIG. 12 is placed on the skin under the patient's chin and configured to image the patient's tongue tissue and / or other airway tissue of the patient (e.g., if also performing an ablation procedure as described above, or simply to generate image data ID of the patient's tongue or other airway tissue).

[0219] Referring now to FIG. 13, there is shown a side cross-sectional anatomical view of an energy delivery device advanced transnasally to position a transducer within a patient's airway consistent with the concepts of the present invention. The EDD 100 of FIG. 13 is of similar construction and arrangement, and may include similar components, as the EDD 100 described herein with reference to FIG. 1 and / or elsewhere. The EDD 100 of FIG. 13 includes a catheter-like geometry, as shown, which may be configured to introduce the EDM 150 through the patient's nares and into the patient's airway (i.e., an intranasal approach). The EDM 150 may be configured to deliver energy (such as ultrasonic energy) to tissue to treat (e.g., reduce volume and / or stiffen) the patient's tongue, soft palate tissue, tonsillar tissue, and / or other airway tissue.

[0220] Referring now to Figure 14, a frontal anatomical view of an energy delivery device positioned on a patient's face is shown, consistent with the concepts of the present invention. The EDD 100 of Figure 14 is of similar construction and arrangement, and may include similar components, as the EDD 100 described herein with reference to Figure 1 and / or elsewhere. The EDD 100 of Figure 14 includes multiple devices, a first device 100a and a second device 100b. The device 100a may include a tissue contacting geometry (such as a rectangle with an aspect ratio of about 1) that is different from the tissue contacting geometry of the device 100b (such as a rectangle with an aspect ratio of greater than 1.5 as shown), for example, when the EDD 100 includes multiple devices having different tissue contacting geometries configured to accommodate different locations on the patient (e.g., different locations on the patient's face as shown).

[0221] In some embodiments, the EDD 100 is configured to enable an operator to perform maxillofacial surgery on a patient.

[0222] Referring now to FIG. 15, a perspective view of a system including an energy delivery device with a shaft and a distally disposed transducer having a diameter approximating that of the shaft is shown, consistent with the concepts of the present invention. The EDD 100 of FIG. 15 is of similar construction and arrangement to the EDD 100 described herein with reference to FIG. 1 and / or others, and may include similar components. The EDD 100 of FIG. 15 includes an EDM 150 disposed at a distal end of an elongated housing 101 (such as pencil-shaped as shown). The diameter of the EDM 150 is approximately the same as the diameter of the housing 101 (diameter D1 as shown), such that the EDM 150 may be introduced through a passageway as small as diameter D1. The diameter of the EDM 150 may be configured for insertion of the EDM 150 through a patient's nostril (e.g., a diameter of less than 10 mm, or less than 6 mm). The EDD 100 may include a functional element 199 including one or more controls, such as a button as shown (e.g., configured as an on-off control). The EDD 100 is operatively attached to a console 500 via cable 501 as shown. The console 500 includes a user interface 590, functional elements 599, and algorithms 50, each as described herein.

[0223] Referring now to FIG. 16, there is shown a perspective view of a system including an energy delivery device with a shaft and a distally disposed transducer having a diameter larger than the diameter of the shaft, consistent with the concepts of the present invention. The EDD 100 of FIG. 16 is of similar construction and arrangement to the EDD 100 described herein with reference to FIG. 1 and / or others, and may include similar components. The EDD 100 of FIG. 16 includes an EDM 150 disposed at a distal end of an elongated housing 101 (e.g., pencil-shaped as shown). The diameter of the EDM 150 (diameter D2 as shown) is larger than the diameter of the housing 101 (diameter D1 as shown), such that the EDM 150 may include a large array of energy delivery elements (e.g., a large array of piezoelectric and / or CMUT ultrasonic energy delivery elements). The EDD 100 may include a functional element 199 including one or more controls, such as a button as shown (e.g., configured as an on-off control). The EDD 100 is operably attached to a console 500 via a cable 501 as shown. The console 500 includes a user interface 590, functional elements 599, and algorithms 50, each as described herein.

[0224]

[00136] Referring now to Figure 17, there is shown a side cross-sectional anatomical view of an energy delivery device including an energy delivery module and a mirror consistent with the concepts of the present invention. The energy delivery device of Figure 17 may include an EDD 100 (such as a clinical medical device used in a clinical procedure) and / or a CEDD 200 (such as an implant or an extracorporeally placed device for chronic use in a patient, as described herein). The EDD 100 and / or CEDD 200 of Figure 17 may be similar in structure and arrangement and include similar components as the EDD 100 and / or CEDD 200, respectively, described herein with reference to Figure 1 and / or others. The EDD 100 and / or CEDD 200 of FIG. 17 (singly or collectively referred to herein as “device 100 / 200”) may include an energy delivery module, EDM 150 / 250 (not shown, but integrated into EDM 150 / 250), which includes one or more energy delivery elements, such as one or more piezoelectric transducers and / or CMUTs configured to deliver ultrasound energy (such as HIFU or other ultrasound energy) to a target tissue. Device 100 / 200 may include a mirror 155 / 255 as shown and described herein. The mirror 155 / 255 (such as an acoustic mirror) may be positioned (e.g., embedded) in proximity to the target tissue (such as nerve N1 as shown). The mirror 155 / 255 and EDM 150 / 250 are positioned on either side of the target tissue (as shown), and energy delivered by EDM 150 / 250 that reaches mirror 155 / 255 is reflected toward the target tissue. In some embodiments, the EDM 150 / 250 is placed on the skin and the mirror 155 / 255 is implanted under the target tissue (e.g., under nerve N1, with N1 positioned between the EDM 150 / 250 and the mirror 155 / 255). In other embodiments, both the EDM 150 / 250 and the mirror 155 / 255 are implanted in the patient (e.g., on either side of the target tissue to be treated).

[0225] 18A-18B, there are shown top and side cross-sectional anatomical views of an energy delivery device consistent with the concepts of the present invention. The EDD 100 of FIGS. 18A-18B is of similar construction and arrangement, and may include similar components, as the EDD 100 described herein with reference to FIG. 1 and / or others. The EDD 100 of FIGS. 18A-18B includes an energy delivery module, EDM 150, with a spoon-like geometry. The EDM 150 may include a curved geometry along one axis (as shown in FIG. 18B) or along multiple axes. The EDM 150 may include one or more piezoelectric transducers and / or one or more CMUTs configured to deliver ultrasonic energy. In FIGS. 18A-18B, the EDM 150 is inserted through a patient's mouth and positioned on the patient's tongue, for example, as described herein, to deliver energy to ablate and / or treat tissue of the tongue thereafter.

[0226]

[0013] Referring now to Figure 19, there is shown a side cross-sectional anatomical view of an energy delivery device inserted transnasally into a patient consistent with the concepts of the present invention. The EDD 100 of Figure 19 is of similar construction and arrangement, and may include similar components, as the EDD 100 described herein with reference to Figure 1 and / or elsewhere. The EDD 100 of Figure 19 includes a first portion 100a including an energy delivery module EDM 150 at a distal portion, and a second portion 100b including a mirror 155 at a distal portion that is an acoustic mirror, all as shown. The EDM 150a includes one or more piezoelectric transducers and / or one or more CMUTs configured to deliver ultrasound energy (such as HIFU and / or other ultrasound energy). As shown in FIG. 19, a distal portion of EDD 100a is inserted into the patient's nasal passage through a first nostril, and a distal portion of EDD 100b is inserted into the patient's nasal passage through the other nostril, with EDM 150 and mirror 155 positioned on either side of a portion of the patient's nasal septum S1 at location L100 as shown. EDM 150 may deliver energy to tissue at location L100 to ablate, soften, and / or otherwise treat tissue of the nasal septum (e.g., as described herein). Mirror 155 is configured and arranged to reflect ultrasonic energy passing through tissue at L100 back to the tissue. In some embodiments, EDD 100b includes another energy delivery module (such as EDM 150b) positioned at (e.g., in place of) mirror 155. In some embodiments, EDD 100 includes only EDD 100a and does not include EDD 100b. Delivery of ultrasonic energy to the L100 may allow for subsequent reshaping of the patient's nasal passages, for example, reshaping facilitated by softening or other treatment caused by delivery of ultrasonic energy to that tissue by the EDD 100. In some embodiments, reshaping of the patient's nasal passages is performed via surgery and / or a catheter device that includes a balloon configured to apply a reshaping force to the patient's nasal passages.

[0227] It should be understood that the above-described embodiments serve only as examples, and further embodiments are envisioned. Any feature described herein in relation to any one embodiment may be used alone or in combination with other features described, and may also be used in combination with one or more features of any other embodiment, or in any combination of any other embodiment. Moreover, 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 a medical procedure on a patient, comprising: Delivering ultrasound energy to generate image data; an array of ultrasound transducers configured to deliver focused ultrasound energy to ablate a plurality of target tissue locations; the plurality of target tissue locations are disposed within a tissue volume having a heterogeneous structure; the image data includes data associated with the plurality of target tissue locations and data associated with one or more non-target tissue locations; the system is configured to distinguish between target and non-target tissue locations based on the image data; The system is further configured to avoid delivery of the focused ultrasound energy to non-target tissue locations based on the image data.

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

3. The system described in claim 1 or 2, wherein the focused ultrasound energy includes high intensity focused ultrasound (HIFU) energy.

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

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

6. The system described in claim 1 or 2, wherein the system is configured to avoid scab formation.

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

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

9. The system described in claim 1 or 2, further comprising a spacer element configured to be positioned between the array of ultrasonic transducers and a tissue surface proximate the multiple target tissue locations.

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

11. The system of claim 1 or 2, wherein the system is further configured to identify and / or track resected and non-resected tissue based on the image data.

12. The system described in claim 1 or 2, wherein the array of ultrasonic transducers is further configured to deliver marking energy comprising ultrasonic energy configured to cause a detectable change in tissue.

13. The system described in claim 12, 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, and the first set of energy delivery settings is different from the second set of energy delivery settings.

14. The system of claim 12, further configured to deliver the marking energy in a specific pattern to mark tissue and to identify the specific pattern based on the image data.

15. The system described in claim 1 or 2, wherein the focused energy is delivered to the multiple target tissue locations in a discontinuous manner.

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