System and Method for Alignment Control for a Neuromodulation Delivery System

Abstract

The discussion of the present invention relates to structures and devices that facilitate the application of an ultrasonic treatment beam (106) to a target anatomical site in a repeatable manner. In some aspects, an alignment controller (30) can be used to analyze an image formed by an ultrasonic transducer. The alignment controller (30) can then send a communication indicating that the energy application device is positioned to provide treatment to the target area or indicating that the device needs to be repositioned. Alignment control of the energy application device provides a guided and repeatable targeting of the target anatomical site even in non-clinical environments.

Description

Technical Field

[0001] The subject matter disclosed herein relates to an alignment control system for setting a target and / or administering to an area of interest of a subject via the application of neuromodulation energy to produce a desired physiological result. Specifically, it is a system for determining the position and orientation of an energy application device in a manner such that untrained personnel can also provide treatment to a subject's anatomical treatment target.

Background Art

[0002] Neuromodulation is used to treat a variety of clinical conditions. However, targeting specific tissues via neuromodulation can be difficult. For example, the precise focusing of neuromodulation energy can vary based on the anatomical structure of an individual subject. Some subjects may have variations in the size or position of organs relative to other subjects based on factors such as height, weight, age, gender, and clinical condition, which can affect targeting when using various neuromodulation techniques.

[0003] In the context of neuromodulation using an ultrasonic device, another common problem can be related to the difficulty of repeatedly delivering accurate and consistent ultrasonic treatment at a prescribed dose in the context of a treatment regime that includes multiple repeated treatments of the treatment site. Additionally, such treatments can be difficult for personnel with minimal training, and it may be necessary for the subject to enter a clinical environment for each treatment session and / or be treated by medically trained personnel. Therefore, treatment by the subject themselves, i.e., in a home environment, is typically not considered feasible for treatment regimes involving ultrasonic neuromodulation.

[0004] For example, when a physician performs a conventional ultrasound examination, the physician places a probe on the body surface and operates in all degrees of freedom (DOFs) until the target scanning plane is reached. In contrast, during patient care or self-care in a home setting, untrained users have little to no ability to understand such an ultrasound image and operate a handheld ultrasound probe to find a target even if the ultrasound image is available. Due to such problems, self-care of ultrasound treatment with precisely set targets, especially in a home environment, has been unrealistic using conventional approaches.

SUMMARY OF THE INVENTION

[0005] The disclosed embodiments are not intended to limit the scope of the claimed subject matter, but only to provide a brief summary of possible embodiments. Indeed, the present disclosure may encompass a variety of forms that may be the same as or different from the embodiments described below.

[0006] In one embodiment, a neuromodulation delivery system includes an energy application device and an alignment controller. The alignment controller is configured to perform operations including receiving, from the energy application device, image data including an image of internal tissue based on a current position and orientation of the energy application device with respect to a subject, and determining an alignment score of the energy application device with respect to an anatomical target based on the image data. Further, the alignment controller is configured to provide a control signal for holding or changing one or both of the current position or orientation of the energy application device in response to the alignment score.

[0007] In another embodiment, the method includes receiving, via a processor, time-series image data from an energy application device at a current position and orientation with respect to a subject, the time-series image data including images of the subject's internal tissue at the current position and orientation over time. Additionally, the method includes determining, via a processor, an alignment score of the energy application device with respect to an anatomical target over time based on the image data, and comparing, via a processor, the alignment score over a time interval corresponding to the time-series image data at the current position and orientation to a predicted alignment score for this time interval at one or both of an additional position or orientation. Further, the method includes providing a control signal for holding or changing one or both of the position or orientation of the energy application device based on the comparison.

[0008] In yet another embodiment, a tracking system includes one or more processors and a memory, the one or more processors configured to execute instructions stored in the memory to perform operations including receiving image data from an energy application device including images of internal tissue based on a current position and orientation of the energy application device with respect to a subject. These operations further include receiving target image data corresponding to the subject's internal tissue and including an anatomical target, identifying the anatomical target in an image frame of the image data and tracking the anatomical target in subsequent frames of the image data, and determining, based on the image data, an alignment score of the energy application device with respect to the anatomical target. Additionally, these operations include comparing the alignment score to a threshold with respect to the anatomical target and providing a control signal for holding or changing one or both of the position or orientation of the energy application device based on the comparison of the alignment score to the threshold. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] These and other features, aspects, and advantages of the present invention will be more fully understood upon reading the following detailed description with reference to the accompanying drawings. Throughout the drawings, like numerals represent like parts.

[0010]

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Mode for Carrying Out the Invention

[0011] Hereinafter, one or more specific embodiments will be described. In an attempt to provide a concise description of these embodiments, not all features of the actual implementation forms are described herein. It should be recognized that in the development of any such actual implementation form, as in any engineering project or design project, many decisions specific to the implementation form must be made in order to achieve developer-specific goals such as compliance with system-related constraints and business-related constraints that may vary for each implementation form. Also, although such development efforts are complex and time-consuming, it should be recognized that they are routine operations in design, fabrication, and manufacturing for those skilled in the art who can benefit from the present disclosure.

[0012] None of the examples or illustrations presented in this book, and no matter how these examples or illustrations are used together, should be regarded as imposing constraints, limitations, or explicit definitions on any terms used in conjunction with them. Instead, these examples or illustrations are described in relation to various specific embodiments and should be regarded as for illustrative purposes only. Those skilled in the art should recognize that any terms used together with these examples or illustrations, whether or not these terms are also listed elsewhere in the specification, are intended to encompass other such embodiments, and that all such embodiments are intended to be included within the scope of these terms. Phrases referring to such non-limiting examples and illustrations include, but are not limited to, "for example," "as an example," "such as," "examples," "including," "in some embodiments," "depending on the embodiment," and "in one embodiment."

[0013] As discussed in this book, one problem that can arise with treatment techniques that include goal-setting transcranial ultrasound neuromodulation in multiple sessions (e.g., once daily, three times per week, once per week) is the need to provide consistent and accurate alignment in each session. In treatment situations that can be implemented in non-clinical environments (e.g., at home) by individuals with little or no medical training (including subjects), it is desirable for the guidance for such goal-setting and alignment to be provided in the simplest possible form. For example, it may be desirable to provide goal-setting and / or alignment assistance without using manual guidance, based on the displayed image and / or by removing or minimizing common causes of user error or failure. In addition, while there is the fact that a "one-size-fits-all approach" is not feasible because of the wide variation in anatomical structures inside and outside the subject's body, it would be further useful to use one form of alignment device suitable for use across a wide population of subjects. With this in mind, the approaches, structures, and techniques described in this book include an alignment device for ultrasound treatment that has customizable elements that guide the user and / or automatically position the treatment device. These systems and devices can be customized to address the large variations across the entire population of subjects, while also being suitable for use in non-clinical environments (e.g., home use by the subject).

[0014] The subject can position the treatment device to target an anatomical target (e.g., an anatomical target for a therapeutic procedure) within the subject's tissue, and the treatment device can include alignment control that enables the treatment device to be positioned and oriented at a location and orientation that provides effective treatment to the anatomical target. To account for the uniqueness of the anatomical structures within each subject's body, the alignment device can include angle adjustment and / or orientation adjustment (e.g., rocking, tilt, spin (rotation)), and a settable depth, to focus the treatment beam substantially on the anatomical target region within the body. Further, in some embodiments, after the position of the anatomical target has been determined within one or more image frames, the system can deliver treatment to this position by electronically steering (steering) the treatment beam to the anatomical target when applying the treatment wave. Alternatively, a treatment transducer having appropriate treatment transducer characteristics (e.g., output control, frequency range, and geometry, etc.), and / or a probe cap having appropriate probe cap characteristics (e.g., angle adjustment, attenuation adjustment (e.g., standoff height and / or composition), other geometries, or features, etc. that are useful for focusing, shaping, or targeting the beam, etc.) can be selected and used to direct the treatment beam to the determined position when applying the treatment wave.

[0015] In yet other examples, some of the embodiments discussed in this book enable a user to position an energy application device using the system's alignment controller to direct the energy application device towards a location where an anatomical target of a subject (e.g., an anatomically pre-determined target by a physician) is located. The alignment controller can receive sensor data from a number of sensors that can monitor the movement of the subject over the entire respiratory cycle and / or can collect image frame data of the subject's internal tissues. The alignment controller can send signals to one or more components of the energy application device to steer and / or focus the treatment beam to correspond to the movement of the subject relative to a pre-defined anatomical target for the subject. This can enable the accurate delivery of the treatment wave even during the movement of the subject's body surface and internal movement due to the respiratory cycle of the subject. The alignment controller can use the image data over time to send one or more signals to adjust the position (e.g., two-dimensional plane, three-dimensional position) and orientation (e.g., rocking, tilting, spinning) of the treatment beam of the energy application device over time to correspond to the position of the anatomical target within the subject's body. Alignment may be achieved manually, in which case alignment can be achieved, for example, through the alignment signal being displayed on the display of the device or an electronic device for the subject for the subject to follow in order to reposition the energy application device. Additionally, alignment may be automatic, in which case the alignment controller can send signals to electronically steer and / or focus the energy application device to a desired position and / or orientation. The automation controller can, upon receiving a signal, automatically adjust the probe module position relative to the user (e.g., in contact with the user or external to the user), automatically adjust the internal position of the probe transducer within the probe housing, or both, to improve the alignment with respect to the anatomical target. The automation controller can perform internal and / or external adjustments of the probe module until the alignment meets the alignment target and / or alignment threshold.

[0016] With this in mind, FIG. 1 shows an example of a neuromodulation system that is configured to deliver energy for neuromodulation as part of a treatment protocol and can be used with the apparatus or structure for alignment and / or placement discussed in this document. Specifically, FIG. 1 is a schematic diagram of a system 10 for neuromodulation, where the system 10 achieves a neuromodulation effect such as the release of neurotransmitters and / or the activation of synaptic components (e.g., presynaptic cells, postsynaptic cells) in response to the application of energy. The system 10 includes a pulse generator (as part of the treatment module 12) coupled to an energy application device (one or more therapeutic transducers 24 shown as part of the probe module 14). The energy application device is configured to receive or otherwise generate an energy pulse that is directed to the anatomical target of the subject during use via, for example, a lead connection or a wireless connection, thereby producing the desired physiological result.

[0017] In some embodiments, the energy application device and / or the pulse generator can be wireless and communicate, for example, with a controller, thereby enabling commands to be given to the pulse generator. As discussed herein, the energy application device can be an extracorporeal device and can operate, for example, to apply energy transcutaneously or in a non-invasive manner from a location external to the subject's body. In some embodiments, it can be integrated with the pulse generator and / or the controller. In embodiments where the energy application device is extracorporeal, the energy application device can be operated by a practitioner or by the subject and can be placed in contact with or at a location above the subject's skin so that an energy pulse is delivered transcutaneously to the desired internal tissue. Once placed to apply an energy pulse to the region of interest, the system 10 can initiate neuromodulation of one or more neural pathways to achieve the targeted physiological result or clinical effect. In some embodiments, the system 10 can be embodied such that some or all of the elements can communicate with each other in a wired or wireless manner.

[0018] The system 10 can include an alignment controller 30 that evaluates characteristics indicating the placement and orientation of the energy application device. Based on such evaluation, the delivery of therapeutic ultrasonic energy can be automatically and / or manually changed, modulated, or steered to achieve the prescribed treatment result. By way of example, the treatment beam can be electronically steered to the target location when applying the treatment wave. Additionally or alternatively, indicators or guidance can be provided to the user via auditory, visual, or tactile indicators, etc., to provide guidance regarding the placement and / or orientation of the energy application device.

[0019] An energy application device as described in this book can provide energy pulses according to various modulation parameters as part of a treatment protocol for applying a prescribed amount of energy. For example, the modulation parameters can include various stimulation time patterns ranging from continuous to intermittent. In the case of intermittent stimulation, the energy is delivered at a certain frequency for some time during the signal "on" time. After the signal "on" time, a time called the signal "off" time follows during which no energy delivery occurs. The modulation parameters can also include the frequency and duration of the stimulation application. The application frequency can be continuous or, for example, delivered at various times within a day or within a week. Further, the treatment protocol can also specify the time of day to apply the energy, or the time relative to a meal or other activity. The treatment time to produce the desired physiological result can continue over various times, including but not limited to several minutes to several hours. In some embodiments, the treatment time with the specified stimulation pattern can continue for 1 hour and be repeated at intervals, for example, at 72-hour intervals. In some embodiments, the energy can be delivered at a relatively high frequency for a relatively short duration, for example, 30 minutes, every 3 hours. The application of energy according to modulation parameters such as treatment time, frequency, and amplitude can be adjusted and controlled to achieve the desired physiological or therapeutic result.

[0020] With the above-described situation in mind, other features shown in FIG. 1 will be described in more detail. Specifically, each aspect and component of the implementation form of system 10 is shown corresponding to several of the above actions. As described above, the block diagram of FIG. 1 shows a treatment module 12 and a probe module 14 that can be used to perform the treatment actions described in this book. An imaging module 16 is also shown, although it will be appreciated that in some embodiments such an imaging module 16 may not be present. In such alternative embodiments, the analysis performed on the imaging data may be performed on the pre-reconstruction (i.e., raw) imaging data, or on the reconstructed but un-displayed image data. By way of example, the administration and / or control of treatment based on data obtained using an imaging transducer or in the imaging module 16 may be based on the reconstructed image (e.g., the signature within the reconstructed image data), or on ultrasonic features present in the non-reconstructed image data.

[0021] First, regarding the probe module 14, in the illustrated example, the probe module 14 includes a transducer 20. As used in this document, the term "transducer" refers to a compartmentalized physical structure of any dimension for converting between a first energy source (i.e., electrical, mechanical, magnetic, etc.) and ultrasonic energy, and the probe module 14 includes a set of one or more transducers. As discussed in this document, the geometric shape of the set of transducers may be a linear (1D) array, an area (2D) array, or any other suitable geometric shape of any dimension, and the imaging transducer and the therapeutic transducer as described in this document may be independent (i.e., separate distinct structures), may be partially shared (i.e., having a partial overlap between the structures used to generate therapeutic ultrasonic energy and imaging ultrasonic energy), or may be completely shared (i.e., having a complete overlap between the structures used to generate therapeutic ultrasonic energy and imaging ultrasonic energy). In some contexts, the terms "imaging transducer" or "therapeutic transducer" may be used to refer to a set of one or more transducers used for the associated imaging or therapeutic action. In other contexts, there may be a discussion about an "imaging beam" or a "therapeutic beam" generated from a set of one or more transducers, in which case the set of transducers used to generate the imaging beam and the therapeutic beam may be independent, partially shared, or completely shared.

[0022] With this in mind, in the illustrated example, the transducer 20 includes both an imaging transducer 22 and a treatment transducer 24. In one embodiment, the treatment transducer 24 may operate at a frequency within the range of 0.2 MHz to 2 MHz (such as 0.5 MHz or 2 MHz). The probe module 14 and / or the transducer 20 may be selectable or interchangeable in some embodiments, allowing a physician to select a probe module 14 and / or a transducer 20 having appropriate nominal depth, axial focus position characteristics, output control, frequency range, angle adjustment, attenuation adjustment, etc., so that the physician can select an appropriate model or type of probe module that is most suitable for the situation of the subject or the target area. Further, in a multi-transducer embodiment, the probe module 14 can be customized by the physician selecting a subset of the transducers for activation to enable coherent addition of the treatment beam in the target area of the anatomical structure with minimal interference by blocking the anatomical structure (such as ribs, etc.).

[0023] In an alternative embodiment, the transducer 20 may instead be a type of transducer capable of operating at both respective imaging frequencies and treatment frequencies (e.g., from 0.2 MHz to 2 MHz during a treatment operation and from 2 MHz to 12 MHz during an imaging operation), including a form in which there is no separately provided transducer for each respective form of operation. In such an embodiment, a single transducer or a single type of transducer can be operated to perform both providing treatment and acquiring data in an imaging modality. Such a single transducer type approach may be suitable in situations where the target area is shallow and / or high power is not required. The probe module 14 and / or the transducer 20 may be selectable or replaceable in some embodiments, enabling a physician to select an appropriate model or type of probe module most suitable for the situation of the subject or target area, such as by allowing the physician to select a probe module 14 and / or transducer 20 having appropriate nominal depth, axial focus position characteristics, output control, frequency range, angle adjustment, and attenuation adjustment, etc.

[0024] In the illustrated example, the probe module 14 includes a microcontroller (MCU) 32 that communicates with the main controller (e.g., a processor) 80 of the treatment module 12, and a field programmable gate array (FPGA) 34 that communicates with the MCU 32 and communicates with sensors 40 and / or actuators 50 that may be present and attached together with the probe module 14. In this configuration, the MCU 32 and the FPGA 34 communicate bidirectionally with components of the main controller 80 to adjust and / or record the operation of various aspects of the probe module 14, or, if present, components directly or indirectly attached to the probe module 14 such as the actuator 50 and / or the sensor 40. With regard to the sensor 40, various types of sensors can be integrated with the probe module 14 or, if separate, made to communicate with the probe module 14. By way of example, the sensor 40 can include one or more inertial measurement units (IMUs) (which can act as attitude sensors), and the IMU can include one or more of an accelerometer, a gyroscope, and a magnetometer. As shown in FIG. 1, if present, one or more sensors 40 can be communicatively coupled to the FPGA 34 or, in other cases, a hardware controller 98. In some embodiments, the main controller 80 can include an alignment controller 30 that determines an alignment score based on the orientation and position of the energy application device and the ability to treat an anatomical target or site at these orientations and positions. In other embodiments, the alignment of the energy application device may be determined through the software-implemented, firmware-implemented, and / or hardware-implemented actions of the alignment controller 30. Additionally, the alignment controller 30 can communicate with an automation controller 31 that can automatically adjust the orientation and / or position of the probe 14, the treatment transducer 24, or any other element of the energy application device. It should be understood that although the alignment controller 30 and the automation controller 31 are shown to be within the main controller 80, the alignment controller 30 and / or the automation controller 31 may be located at any suitable position within the energy application device (i.e., in some embodiments these controllers may be embodied as separate, distinct controllers).In addition, the alignment controller 30 may include any suitable hardware, firmware, and / or software for determining the alignment of the energy application device. One or more controllers (e.g., alignment controller 30, automation controller 31) shown inside the energy application device may be software modules and / or routines executed or implemented by a dedicated circuit provided in the main controller 80, or may be separated as various hardware blocks (e.g., together with additional processing units).

[0025] Regarding the treatment module 12, as described above, the embodiment of the treatment module 12 may include a main controller (e.g., a processor) 80, and the main controller 80 itself may include or execute various subordinate modules or routines that can be stored in the memory structure 84. For example, the main controller 80 may include or execute modules or routines that provide functions such as image streaming and remote control, alignment control, recognition and tracking of anatomical structures by artificial intelligence (AI), dose integration, user interface, assisted analysis, system guidance and automation, and data recording.

[0026] Similar to the case of the probe module 14, in some embodiments, the treatment module 12 can include a hardware controller 86, and the hardware controller 86 can include its own MCU 88 and FPGA 90. Although illustrated as separate modules for purposes of illustration and description, practically, the probe module 14 and the treatment module 12 can actually be one and the same (i.e., an integrated structure or device configured to perform the functions of both the treatment module and the probe module discussed in this document). With this in mind, although discussed separately in this document, practically, the hardware controllers 86 and 98 can be implemented as a single hardware controller. In the illustrated example, the MCU 88 is shown as communicating with the main controller 80 and the components and modules of the main controller 80. The FPGA 90 communicates with and / or controls other components of the treatment module 12, such as the treatment pulsar / receiver 92 (shown as communicating with the treatment transducer 24 of the probe module 14), the safety circuit 94, and / or the output management circuit 96. Practically, the combination of the main controller 80 and the hardware controllers 86, 98 can control the operations of the treatment module 12 and the probe module 14 to perform treatment applications, etc., according to the processes and structures described in this document. In some embodiments, the hardware controllers 86, 98 may not have the MCU 88 and / or the FPGA 90. Additionally, the system 10 may include a single hardware controller and / or may include multiple hardware controllers. That is, each function discussed in this document corresponding to various controllers may be combined as a single controller, divided into multiple controllers, or otherwise associated with any number of controllers or controller configurations without changing the respective functions discussed in this document. That is, the discussions and examples here are intended to illustrate and facilitate the explanation, and are not intended to limit the functions discussed to the described components or component configurations.Furthermore, the hardware controllers 86, 98 may include any programmable logic device and / or processor, and / or the hardware controllers 86, 98 and the main controller 80 as described above may be coupled as a single main processor device. Additionally, as shown in FIG. 1, one or both of the main controller 80 and / or the hardware controller 86 may communicate with one or more memory structures 84 (such as volatile or non-volatile memory, firmware structures, and mass data storage, etc.). As can be appreciated, code or executable routines for performing operations (such as treatment procedures or protocols) may be stored in the memory 84 for use by other components. Additionally, one or more adjustable parameters (such as system settings, imager settings, and sensor settings or thresholds, etc.) may be stored in the memory structure 84 by users or the like who configure or calibrate the system 10 for use by a given subject for each treatment protocol. Additionally, the memory structure 84 may be used to store data (such as image data) acquired or generated as part of a treatment procedure for later reading and evaluation, etc.

[0027] In the illustrated example, imaging module 16 is also shown as a component of the overall system. Such a module, if present, can control or monitor the operation of transducer 20 (e.g., imaging transducer 22) to control the generation, collection, and / or processing (e.g., reconstruction) of imaging data. In the illustrated example, imaging module 16 is also shown as communicating with the main controller 80 of treatment module 12, and the main controller 80 can control the operation of imaging module 16 or respond to feedback and data from imaging module 16. Similar to the probe module 14 and treatment module 12 discussed above, imaging module 16 is shown as a separate module in FIG. 1 to facilitate illustration and description of the concepts of operation. However, as in each of the above examples, imaging module 16 may actually be one and the same as one or both of probe module 14 and treatment module 12 (i.e., an integrated structure or device configured to perform the combined operations of the imaging module discussed herein, as well as one or both of the treatment module and probe module).

[0028] With the above description of the system in mind and against this backdrop, the techniques of the present invention relate to an ultrasound-guided therapy system with image (or un-reconstructed image data) guidance. In some embodiments, the alignment controller 30 internal to system 10 can provide target setting and / or alignment assistance for use with the energy application device discussed with respect to FIG. 1.

[0029] Herein, various example embodiments of tracking and alignment methods, collectively referred to as tracking devices or tracking structures, are described. These tracking devices, when used, can facilitate the safe and effective application of ultrasound neuromodulation therapy, including when operated by non-clinical environments and / or users who have not received training (e.g., the subject themselves, or other individuals who have not received clinical or medical training). As such, some of the embodiments described herein are designed or configured to be user-friendly for the end user.

[0030] To describe the background, in conventional ultrasonic scanning, there is a high degree of variation across the subject population. A trained ultrasonic technician adapts to such subject variation by adjusting the placement of the probe on the body surface, the probe angle, and the system settings to reach the target diagnostic image. As described in this book, the tracking method of the present invention helps to avoid such manual operations (thereby facilitating placement and use by individuals who have not received training), and enables easy tracking of the subject's region of interest and hands-free operation tailored to the individual during the treatment session. The energy application device may be attached using body-worn equipment of the subject, or may be freely handled around the body of the subject. In other embodiments, the energy application device may initially be freely handled and / or its position and orientation adjusted, and later fixed using body-worn equipment.

[0031] As discussed in the previous section, the energy application device can be automatically and / or manually steered with respect to the anatomical target for treatment of the subject. The treatment module 12 of the system 10 can include an alignment controller 30, which can analyze the current treatment area of the energy application device (e.g., the area within the ultrasonic image data where the treatment transducer 24 can perform treatment) based on the ultrasonic image data of the subject, and can evaluate the alignment of the current treatment area of the probe module 14 with respect to the anatomical target for subject treatment. Based on such evaluation, the delivery of therapeutic ultrasonic energy can be automatically and / or manually changed, modulated, or steered to achieve the prescribed treatment result. By way of example, the treatment beam can be electronically and / or manually steered to the anatomical target when applying the treatment wave.

[0032] With the above in mind, FIG. 2 is a schematic diagram of the probe module 14 of the system 10 according to an embodiment of the present disclosure. The probe 14 (e.g., an energy application device) can include one or more transducers 20 (e.g., a treatment transducer 22, an imaging transducer 24), and one or more position sensors 40 (e.g., an inertial measurement unit (IMU) sensor, an optical tracking sensor). The ultrasonic probe module 14 can be arranged along the subject's body 100 and can include a transducer 20 that forms one or more images of the internal tissue of the subject's body 100 corresponding to the anatomical target 104 (e.g., an organ, a tissue) for a treatment procedure. Based on image tracking and analysis via an alignment controller 30 based on the subject ultrasonic image and the determined treatment area 102 (e.g., the area within the ultrasonic image data where the treatment transducer can perform treatment) for the desired anatomical target 104 of the subject, the probe module 14 can be automatically steered and / or manually steered (e.g., in real time).

[0033] First, the alignment controller 30 can receive ultrasonic image data (e.g., static image data and / or time-series image data corresponding to the respiratory cycle of the subject). In addition, the alignment controller 30 can receive additional data including sensor data 40 (e.g., inertial measurement unit (IMU) data, optical tracking data). The image data received by the alignment controller 30 can include two-dimensional planar image data, three-dimensional volume image data, A-line image data, Doppler image data, or other ultrasonic image data. The alignment controller 30 can receive initial subject data (e.g., image data) related to the anatomical target 104 for treatment wave administration. The initial subject data can be determined based on past subject data or population data, etc. The initial subject data can include ultrasonic images and / or other image data of the anatomical structure and tissue of the subject, or image data based on the population related to the desired anatomical target 104. The initial subject data can include the anatomical target 104 identified by the physician for treatment wave administration and / or other subject image data. In addition, the anatomical target 104 can be determined based on an AI model trained using population data, specific subject data, or both. The AI model can be for a specific anatomical structure, and multiple models can correspond to different anatomical sites. The AI model for a specific subject can learn the observed trajectory of the anatomical target 104 of the subject or utilize time-series images to feed forward one or more pre-detections of the anatomical target 104 as additional input for determining the position of the anatomical target 104 in the image frame. The AI model can also track the overall cumulative and / or average alignment metric during the administration session and supply this metric to a continuous learning algorithm that optimizes the device for the subject to maximize the subject metric over time.

[0034] The probe module 14 can be moved relative to the subject's body 100, and the alignment controller 30 can receive ultrasonic image data via the imaging transducer 24 of the probe module 14. The imaging transducer 24 can generate image data corresponding to the two-dimensional image plane 108 in an unreconstructed form or in any other suitable image format. The alignment controller 30 can determine the position of the anatomical target 104 within this image data by comparing the received ultrasonic image data with pre-acquired image data of the anatomical target 104 and / or pre-acquired image data of the anatomical regions surrounding the anatomical target 104, where the pre-acquired image data may be of a specific subject, population-based, or both. The alignment controller 30 can extract the position of the anatomical target 104 within the ultrasonic image data using the image data and determine the position of the image data relative to the anatomical target 104. Note that since the ultrasonic image data received by the alignment controller may or may not completely contain, partially contain, or contain the anatomical target 104, in some embodiments, it should be understood that the alignment controller 30 may not be able to determine the position of the anatomical target 104 within the image data. The alignment controller 30 can also determine the position of the center point within the anatomical target 104 and / or within the volume of the subject corresponding to the anatomical target 104.

[0035] Based on the received image data, the alignment controller 30 can determine the level of alignment of the treatment area 102 to the positioned anatomical target 104 and / or an alignment score indicating the alignment (e.g., a percentage alignment score, an average percentage alignment score, an indicator of alignment by yes and / or no). The alignment score can be calculated based on determining the treatment area of the probe module 14 (e.g., the area within the ultrasonic image data where the treatment transducer can perform treatment), and determining whether the anatomical target 104 is within an appropriate range of the treatment area 102. The alignment score can also be calculated based on whether the anatomical target 104 is within the surrounding area 110 (e.g., an area of a specific subject defined by a physician and associated with the position of the anatomical target), to ensure a highly reliable alignment and prevent false positives based on the detection of inaccurate anatomical targets 104 by the alignment controller 30. It should be understood that the alignment score can be calculated using the alignment controller 30 based on any suitable criteria, based on the received image data, past subject data, population-based data, and / or based on the surrounding area 110 defined by the physician within the subject image data.

[0036] In some embodiments, the alignment score may be determined by the alignment controller 30 for each ultrasonic image frame (e.g., a time-series image) taken over a predetermined time, as discussed above. Additionally, within a set of time-series image data, a cumulative alignment score may be determined based on determining the average and / or weighted average of the alignment scores of each image frame. The cumulative alignment score may be calculated by averaging the alignment scores of each image frame for the image data collected over some time (e.g., 5 seconds, 10 seconds, 15 seconds), and / or may be calculated by determining an average alignment score based on one or more alignment scores associated with the image frames collected over the respiratory cycle of the subject.

[0037] The alignment controller 30 can analyze the image data (e.g., time-series image data) to determine whether the alignment score determined for the energy application device is within a predetermined threshold range (e.g., percentage alignment range) of the anatomical target 104. The alignment score may correspond to an instantaneous score based on the percentage overlap of the position of the identified anatomical target within the image frame data for the treatment area 102 and / or the surrounding area 110 in the image frame, or may correspond to an integrated score based on the percentage alignment over time in the image series frame data (e.g., based on the percentage overlap of the anatomical target for the treatment area and / or the surrounding area in each image that is aligned / not aligned in each image frame), or may correspond to a combination of both methods. The predetermined threshold range may correspond to a set threshold for effective treatment wave administration based on the subject data. For example, while the alignment score is within the predetermined threshold range of 90% alignment to 100% alignment, the alignment score corresponding to the predetermined threshold range of 90% alignment to 100% alignment corresponds to the application of treatment wave administration for 5 minutes, and while the alignment score is within the predetermined threshold range of 50% alignment to 80% alignment, the alignment score corresponding to the predetermined threshold range of 50% alignment to 80% alignment may correspond to the application of treatment wave administration for 10 minutes. Since the treatment wave administration time can be dynamically adjusted based on the alignment score threshold range, the time of application of the treatment wave corresponds to the alignment score over time, or in other cases is based on the alignment score over time. It should be understood that any suitable treatment wave administration time and / or administration level can be applied to the subject based on the predetermined threshold range of the alignment score. In addition, the predetermined threshold range may be any suitable range based on the fully or partially predicted administration session time, or may be any suitable range based on the predicted treatment efficacy based on the alignment score, or may be based on both. In some examples, the alignment controller 30 determines whether the current alignment score is greater than one or more predicted alignment scores, and if the current alignment score is greater than one or more predicted alignment scores, can send a control signal for the energy application device to maintain the current position and orientation.This enables the evaluation of the possible positions and orientations of the energy application device relative to its current position from the perspective of the effectiveness of the dose. A predicted alignment score can be calculated based on one or more possible positions and orientations of the energy application device and compared with the alignment score determined for the current position and orientation of the energy application device. If the alignment score for the current position and orientation of the energy application device is greater than one or more of the predicted alignment scores, the energy application device can maintain its current position and orientation. If the predicted alignment score is higher than the current alignment score, the alignment controller 30 can send a communication to relocate the energy application device to the predicted orientation and position corresponding to the predicted alignment score. This communication may be a control signal to move the energy application device to enable manual adjustment of the position and orientation by the user or, in other cases, to display an indicator to the user for adjusting the energy application device, or it may be a control signal for an automation controller 31 to automatically adjust the position or orientation of the energy application device by electronically steering and / or actuating one or more of the treatment transducers 24 and / or probe modules 14 of the energy application device, or it may be a combination of both manual and automatic adjustment methods.

[0038] In addition, the alignment controller 30 can receive time-series image data and determine whether the position of the anatomical target 104 within the time-series image data is aligned with the treatment area 102 of the energy application device in order to achieve the desired percentage of the target administration time such that the entire treatment dose can be delivered within a threshold time limit (e.g., the time limit determined for an effective treatment dose). This time-series data can represent the target path 112 of the anatomical target 104 over time based on the movement of the subject's body (e.g., the respiratory cycle).

[0039] Furthermore, the alignment controller 30 can determine an acceptable relative alignment based on the time-series image data and position data collected based on the observed trajectory of the anatomical target 104 compared to the treatment area 102 (e.g., determined by the mechanical and / or electrical steering and / or focusing capabilities of the treatment beam 106 generated by the treatment transducer 22). The alignment controller 30 can determine the observed trajectory of the target path 112 of the anatomical target 104 with respect to the subject body 100 during the subject respiratory cycle, and the alignment controller 30 can determine an on-target percentage of alignment based on the observed trajectory. In some embodiments, the learned trajectory can be stored in the memory 84 as the trajectory of a particular subject and used as an input for an algorithm used to align the anatomical target 104, track the anatomical target 104, or both.

[0040] The alignment controller 30 can send a signal indicating whether the determined target mid-percentage of alignment is within the range of the threshold of the target mid-percentage of alignment for effective therapeutic wave administration (e.g., 70% alignment, 80% alignment, 90% alignment) to a display and / or an electronic device associated with the subject. For example, the treatment module 12 can indicate to the user (e.g., the subject and / or the operator) by displaying on the display of the system 10 a green light or other indicator that the treatment beam 106 is properly aligned for effective therapeutic wave administration, and the green light may indicate that no adjustment is needed. The energy application device can also display a signal indicating a direction adjustment in position and / or orientation to improve the alignment with the anatomical target 104. The direction signal can include the degrees of freedom (DOF) when the treatment transducer 22 should be repositioned. It should be understood that the signal can correspond to any visual cue (cue), tactile cue, auditory cue, or other guiding cue displayed to the user. The signal can be a control signal for displaying to the user (or otherwise informing the user) an indicator for moving the energy application device to enable manual position and / or orientation adjustment by the user, or it can be a control signal for an automation controller 31 to automatically adjust the position or orientation of the energy application device by electronically steering and / or actuating one or more treatment transducers 24 and / or probe modules 14 of the energy application device, or it can be a control signal for a combination of both manual and automatic adjustment methods.

[0041] The direction signal can also instruct the user adjustment of the probe module 14 with respect to the subject surface 100. The direction signal can include external and / or internal adjustments suggested to maintain alignment of the threshold percentage, and can provide the user with a number of guidance cues throughout the administration session. For example, the direction signal can be sent to the user device and / or displayed on the display of the system 10, and can instruct the user to reposition the probe 14 in the upward and / or downward direction with respect to the subject surface 100. The direction signal can be sent from the alignment controller 30, and can indicate to the subject when the directional movement to align the probe module 14 to the desired position determined by the alignment controller 30 to maintain alignment of the threshold percentage for effective treatment has been completed. Once the alignment of the device within the threshold range of the anatomical target 104 has been confirmed via communication with the alignment controller 30, the treatment transducer 22 can generate a focused treatment beam 106 to provide treatment to the anatomical target 104 of the subject.

[0042] In addition, in some embodiments, the direction signal from the alignment controller 30 may be sent to the automation controller 31, enabling movement of the probe module 14 without user input to maximize the alignment criteria provided in the direction signal of the alignment controller 30. Further, in some embodiments, the alignment controller 30 may send a direction signal to the automation controller 31 to enable the adjustments embodied by the subject and the automated adjustments to be combined to achieve alignment of the threshold percentage for effective treatment wave administration. Upon receiving the signal, the automation controller 31 may automatically adjust the position of the probe module 14 in the user, adjust the internal position of the probe transducer 20, or do both to improve alignment with respect to the anatomical target 104. The automation controller 31 can perform internal and / or external adjustments of the probe module 20 until the alignment matches the target alignment and / or the threshold alignment.

[0043] For example, when the alignment controller 30 determines that the alignment is below the threshold target alignment, it can send a signal to the automation controller 31 to adjust the position and / or orientation of the probe module 14 according to the position of the anatomical target 104 in the image data. The alignment controller 30 can dynamically send adjustments regarding the position and / or orientation to the automation controller 31 so as to accommodate the patient's respiratory cycle, patient movement, and the like. Thereby, it is possible to ensure that the automatic alignment of the probe module 14 is on target so that treatment can be effectively performed.

[0044] In some embodiments, the energy application device may include a visual cue and / or a signal output via the alignment controller 30 in combination with automatic alignment via the alignment controller 30 sending one or more signals to the automation controller 31 to adjust the position and / or orientation of the probe module 14. For example, the alignment controller 30 can display a red light to inform the user that the energy application device meets or does not meet the threshold alignment, emit an audible sound, and / or generate a tactile signal. The alignment controller 30 may also send a signal to the automation controller 31 for automatically adjusting the position and / or orientation of the probe module 14 based on the received image of the alignment threshold and the anatomical target 104. Any combination of manual and / or automatic alignment of the probe module 14 can be implemented to efficiently apply the treatment wave to the patient throughout the treatment session.

[0045] In addition, the alignment controller 30 can also receive sensor data together with the image data in order to determine a directional movement that causes alignment of the observed trajectory and a threshold percentage for effective therapeutic wave administration. The sensor data can correspond to or be generated using an inertial measurement unit (IMU) position sensor that can include one or more of an accelerometer, a gyroscope, and a magnetometer, an optical tracking sensor, or any other suitable sensor. The alignment controller 30 can receive sensor data that includes data related to the surface movement of the subject over time (e.g., respiratory cycle) and the position of the probe 14 over time (e.g., in the case of a handheld device). It should be understood that any suitable position and / or image data can be used by the alignment controller 30 to determine the position of the appropriate probe 14.

[0046] With the above in mind, FIG. 3 is a flowchart of a method 120 for alignment control of an energy application device according to an embodiment of the present disclosure. The alignment controller 30 of the energy application device can receive image frame data generated via an imaging transducer 24 (e.g., an ultrasonic transducer), and can determine based on the received image data whether the alignment score of the energy application device exceeds a threshold alignment score for effective therapeutic wave application.

[0047] At block 122, the alignment controller 30 receives image frame data generated by one or more imaging transducers 24 of the energy application device. The image frame data can include an image frame of the subject's internal tissue with respect to the position and orientation of the energy application device on the subject surface 100. The image frame data can include time-series data of the subject's internal tissue with respect to the position of the energy application device over time. The time-series image frame data can be collected over one or more respiratory cycles of the subject or any other suitable amount of time related to the movement of the subject surface 100.

[0048] The alignment controller 30 determines in block 124 whether the anatomical target 104 has been detected in the image data. The alignment controller 30 can determine whether the anatomical target has been detected in one or more frames of the image data. As discussed above, the alignment controller 30 can locate the position of the anatomical target 104 within this image data by comparing the received ultrasonic image data with pre-acquired image data of the anatomical target 104 and / or pre-acquired image data of the anatomical site surrounding the anatomical target 104. The alignment controller 30 can extract the position of the anatomical target 104 within the ultrasonic image data using the image data and locate the position of the image data relative to the anatomical target 104. If the alignment controller 30 determines that the anatomical target 104 has not been detected in the image data, then in block 126 the alignment controller 30 determines that the energy application device is not aligned with the anatomical target 104. Based on the misalignment of the anatomical target 104, the alignment controller 30 updates the alignment score in block 128.

[0049] If an anatomical target 104 is detected within the image data, the alignment controller 30 determines in decision block 130 whether the anatomical target 104 is within the treatment region 102 (e.g., the region within the ultrasound image data where the treatment transducer can perform treatment). In some embodiments, the alignment controller 30 can determine whether the anatomical target 104 is within the treatment region 104 and, in addition, whether the anatomical target 104 is within the surrounding region 110 defined by the physician. As discussed above, in some embodiments, the surrounding region 110 (e.g., the region of a particular subject defined by the physician and associated with the location of the anatomical target) can be embodied in the decision-making process for treatment, and this region 110 can be used to ensure a reliable alignment and prevent false positives based on an inaccurate detection of the anatomical target 104 by the alignment controller 30. If the anatomical target 104 is detected to be within the treatment region 102, the alignment controller 30 determines in block 132 that the current image data is aligned, and the alignment controller 30 updates in block 128 the alignment score associated with the position and orientation of the energy application device. If the alignment controller 30 determines in decision block 130 that the detected anatomical target 104 is not within the surrounding region 110 and the treatment region 102, the method 120 returns to block 126 and the alignment controller 30 determines that the current image data is not aligned.

[0050] In block 128, the alignment controller 30 updates an alignment score for the energy application device based on whether the current image is aligned. As discussed above, the alignment controller 30 can determine the level of alignment of the treatment area 102 with the positioned anatomical target 104 and / or an alignment score (e.g., a percentage alignment score, an average percentage alignment score, an indicator of alignment by yes and / or no) indicating alignment. The alignment score can be calculated based on determining the treatment area of the probe module 14 (e.g., the area within the ultrasonic image data where the treatment transducer can perform treatment) and determining whether the anatomical target 104 is within the appropriate range of the treatment area 102. The alignment score can also be calculated based on whether the anatomical target 104 is within the surrounding area 110 (e.g., an area of a particular subject defined by the physician and associated with the position of the anatomical target) to ensure a highly reliable alignment and prevent false positives based on the detection of an inaccurate anatomical target 104 by the alignment controller 30. It should be understood that the alignment score can be calculated using the alignment controller 30 based on any suitable criteria, based on the received image data and past subject data, and / or based on the surrounding area 110 defined by the physician within the subject image data. In some embodiments, the anatomical target 104 can be located over time in one or more images to determine the trajectory of the anatomical target 104. The observed trajectory can be compared with the beam steering capabilities of the energy application device to calculate a cumulative alignment score predicted over the trajectory that can be used. The cumulative alignment score can correspond to one or more respiratory cycles of the subject and can be weighted over time. Additionally, in some embodiments, a predicted trajectory of the anatomical target 104 can also be calculated.

[0051] The alignment controller 30 determines in the determination block 134 whether the updated alignment score satisfies a predetermined threshold range. As discussed above, the predetermined threshold range may correspond to a set threshold for effective therapeutic wave administration based on the subject data. For example, while the alignment score is within the predetermined threshold range of 90% to 100% alignment, the alignment score corresponding to the predetermined threshold range of 90% to 100% alignment corresponds to the application of therapeutic wave administration for 5 minutes, and while the alignment score is within the predetermined threshold range of 50% to 80% alignment, the alignment score corresponding to the predetermined threshold range of 50% to 80% alignment may correspond to the application of therapeutic wave administration for 10 minutes. Since the therapeutic wave administration time can be dynamically adjusted based on the alignment score threshold range, the time of application of the therapeutic wave administration corresponds to the alignment score over time, or in other cases is based on the alignment score over time. It should be understood that any suitable therapeutic wave administration time and / or administration level can be applied to the subject based on the predetermined threshold range of the alignment score. Additionally, the predetermined threshold range may be any suitable range based on the fully or partially predicted administration session time, or any suitable range based on the predicted therapeutic efficacy based on the alignment score, or based on both. If the alignment controller 30 determines that the updated alignment score is not within the predetermined threshold range, the alignment controller 30 generates a control signal for realignment in block 136. The control signal for realignment may be sent based on the fact that the alignment score is outside the predetermined threshold range over a quantity greater than some number of seconds (e.g., 5 seconds, 10 seconds) or some number of image frames (e.g., 1, 5, 10). Then, the method 120 can proceed to determine the alignment score, and if the alignment score is within the predetermined threshold range, the energy application device can start or resume tracking and / or administration.

[0052] The control signal may be sent to additional controllers and / or modules within the main controller 80 that can determine the adjustments needed to improve the alignment score. The controller of the automation controller 31 can then send a communication to the user device or user interface, whereby the user device or user interface displays instructions on how to adjust the energy application device to increase the alignment score. It should be understood that any suitable control signal can be displayed and / or used to instruct the adjustment to the energy application device. Additionally, the control signal can enable the energy application device to automatically steer and / or reposition to a more suitable position for effective therapeutic wave delivery. The control signal can also instruct adjustments regarding the position and orientation of the probe module 14 to align the predicted trajectory of the target path 112 with the anatomical structure. The control signal can include adjustments to the position and orientation of the probe module 14 that enable the alignment score to meet, exceed, and / or maximize a predetermined threshold range determined for the anatomical target 104. In some embodiments, the trajectory of the target path 112 may be stored in the memory of the system 10 as the trajectory of a particular subject.

[0053] If the alignment controller 30 determines that the alignment score meets a predetermined threshold range, the alignment controller 30 determines in the decision block 138 whether the user of the energy application is ready to start the administration. The alignment controller 30 can receive a signal that the user has input that the user is ready to start the administration. If the alignment controller 30 receives a signal that the user is ready to start the administration, the alignment controller can start the administration workflow in block 140. Additionally, if a therapeutic wave administration session has started, the alignment controller 30 can hold the therapeutic wave administration and send a signal to the energy application device to correspondingly hold the position or orientation of the energy application device.

[0054] If the alignment controller 30 has not received a notification that the user is ready to start administration, method 120 returns to block 122 and continues to receive ultrasonic image data of the subject tissue. It should be understood that the alignment score and the predetermined threshold alignment can be calculated using any suitable method for alignment calculation. It should also be understood that method 120 can be implemented using any of the alignment score determinations described above.

[0055] Method 120 for alignment can be used via the user interface of the application, along with an application that can assist with alignment according to the user guide. With this in mind, FIG. 4 is a diagram of a user interface 150 for alignment control of the probe of the neuromodulation delivery system of FIG. 1 according to an embodiment of the present disclosure. The user can be guided by an application including the user interface 150 during alignment control of the energy application device. The user interface 150 can display an ultrasonic image formed by the imaging transducer 22 of the probe module 14. The user interface 150 can also display an alignment score visual image 152, which includes the current alignment score for the probe module 14 and also includes a target alignment score metric 154 and a best alignment score metric 156.

[0056] At the start of a dosing session, the user can open an application on a user device attached to the energy application device, and the application can display a user interface 150 that displays updated ultrasonic image data generated by the imaging transducer 22 of the energy application device. If an anatomical target 104 is detected within the image data by the alignment controller 30, the user interface 150 can also display a square border around the anatomical target 104, and can also display a border indicating a predefined surrounding region 110 used further to determine alignment with the determined position of the anatomical target 104 within the image data, by a physician. The user interface 150 can be updated over time based on real-time imaging data generated by the imaging transducer 22 and analyzed by the alignment controller 30. The user interface 150 can also display an alignment score visualization 152 that can include a progress bar (progress status bar graph) corresponding to a percentage alignment score calculated by the alignment controller 30. The alignment score visualization 152 can also include a target alignment score 154 for sufficient dosing. The target alignment score 154 can be predefined by the application based on subject data and population data regarding the treatment of the subject's condition. The target alignment score 154 can also be the same one predefined threshold for effective treatment wave dosing. Additionally, the alignment score visualization 152 can include a best alignment score 156 marker set to the best alignment score achieved over the dosing session.

[0057] Furthermore, the energy application device can guide the user based on the image displayed on the user interface 150 and based on whether the anatomical target 104 is within the surrounding region 110 superimposed on the current display image. The user interface 150 can also provide an update based on a control signal generated by the alignment controller 30 to reposition and / or adjust the orientation and / or position of the energy application device based on the determined alignment score.

[0058] With the above in mind, FIG. 5 is a flow diagram of a method 160 for delivering a treatment wave via a probe module 14 of a neuromodulation delivery system 10 (e.g., a system) according to an embodiment of the present disclosure. An alignment controller 30 of an energy application device can receive image frame data generated via an imaging transducer 24 (e.g., an ultrasonic transducer), and can determine based on the received image data whether a determined alignment score of the energy application device exceeds a threshold alignment for effective treatment wave application, and can then initiate administration and be able to monitor alignment throughout the administration session.

[0059] At block 162, the alignment controller 30 receives image frame data generated by one or more imaging transducers 24 of the energy application device. The image frame data can include an image frame of the subject's internal tissue with respect to the position and orientation of the energy application device relative to the subject surface 100. The image frame data can include time-series data of the subject's internal tissue with respect to the position of the energy application device over time. The time-series image frame data can be collected over one or more respiratory cycles of the subject, or any other suitable amount of time related to movement of the subject surface 100.

[0060] The alignment controller 30 determines in the determination block 164 whether the anatomical target 104 has been detected in the image data. The alignment controller 30 may determine whether the anatomical target has been detected in one or more frames of the image data. As discussed above, the alignment controller 30 can locate the position of the anatomical target 104 in this image data by comparing the received ultrasonic image data with the pre-acquired image data of the anatomical target 104 and / or the pre-acquired image data of the anatomical parts around the anatomical target 104. The determination of the position of the anatomical target 104 may be determined based on the image data of a specific subject and / or based on the image data based on the population corresponding to the anatomical parts around the anatomical target 104. The alignment controller 30 can extract the position of the anatomical target 104 in the ultrasonic image data using the image data and determine the position of the image data relative to the anatomical target 104. If the alignment controller 30 determines that the anatomical target 104 is not detected in the image data, the alignment controller 30 determines in block 168 that the energy application device is not aligned with the anatomical target 104. Based on the misalignment of the anatomical target 104, the alignment controller 30 updates the alignment score in block 170.

[0061] In block 172, the alignment controller 30 sends a control signal to disable the treatment in response to the alignment for treatment wave administration being misaligned. In the determination block 174, the alignment controller 30 determines whether the alignment score meets one or more realignment criteria. The realignment criteria may include a numerical threshold for the alignment score, a threshold for the median percentage of the alignment score over time relative to the alignment target, or any other suitable numerical and / or time-dependent alignment criteria. For example, if the alignment score is 20% lower than a predetermined alignment score threshold, it meets the realignment criteria, and the alignment controller 30 can send a signal to trigger realignment. In another example, if the alignment score is determined to be lower than a predetermined threshold range for a period longer than 5 consecutive seconds, the alignment controller 30 can send a signal to trigger realignment.

[0062] For example, during a certain session, the alignment score may still exceed a predetermined threshold range, and this administration session can continue. If the alignment score does not meet the realignment criteria, method 160 returns to block 162 to receive the current image data. If the alignment score meets the realignment criteria, the alignment controller 30 can return to the alignment workflow at block 176.

[0063] Returning to block 164, if the anatomical target 104 is detected within the image data, the alignment controller 30 determines at decision block 178 whether the anatomical target 104 is within the treatment area 102 (e.g., the area within the ultrasonic image data where the treatment transducer can perform treatment). As discussed above, the surrounding area 110 (e.g., the area of a specific subject defined by the physician and associated with the position of the anatomical target) can be used together with the treatment area 102 to ensure a highly reliable alignment and prevent false positives based on an inaccurate detection of the anatomical target 104 by the alignment controller 30. If the anatomical target 104 is detected to be within the surrounding area 110 and / or the treatment area 102, the alignment controller 30 determines at block 180 that the current image data is aligned, and the alignment controller 30 updates at block 182 the alignment score associated with the position and orientation of the energy application device. If the alignment controller 30 determines at decision block 178 that the detected anatomical target 104 is not within the surrounding area 110 and / or the treatment area 102, method 120 returns to block 168, and the alignment controller 30 determines that the current image data is not aligned.

[0064] In block 182, the alignment controller 30 updates an alignment score for the energy application device based on image alignment. As discussed above, the alignment controller 30 can determine a level of alignment and / or an alignment score (e.g., a percentage alignment score, an average percentage alignment score, an alignment indicator based on yes and / or no) indicating the alignment of the treatment area 102 of the positioned anatomical target 104. Additionally, the alignment score can correspond to one or more alignment criteria associated with a threshold alignment score for an alignment indicator based on yes and / or no. The alignment criteria can also correspond to a combination of an alignment score and one or more checklist items associated with probe alignment. The checklist and the alignment score can be used in combination as alignment criteria to determine an alignment indicator based on yes and / or no.

[0065] The alignment score can be calculated based on determining a treatment area (e.g., an area within the ultrasonic image data where a treatment transducer can perform treatment) of the probe module 14 and based on whether the anatomical target 104 is within an appropriate range of the treatment area 102. The alignment score can also be calculated based on whether the anatomical target 104 is within the enclosed area 110 (e.g., an area of a particular subject defined by a physician and associated with the location of the anatomical target) and the treatment area 102 to ensure a highly reliable alignment and prevent false positives based on detection of an inaccurate anatomical target 104 by the alignment controller 30. It should be understood that the alignment score can be calculated using the alignment controller 30 based on any suitable criteria, based on received image data and past subject data and / or based on the enclosed area 110 defined by a physician within the subject image data.

[0066] The alignment controller 30 enables the delivery of treatment waves to the anatomical target 104 in block 184. The treatment waves can be delivered based on the alignment score and a predetermined threshold range corresponding to the alignment score. For example, the predetermined threshold range can correspond to a set threshold for effective treatment wave administration based on the subject data. For example, an alignment score corresponding to a predetermined threshold range from 90% alignment to 100% alignment corresponds to the application of treatment wave administration for 5 minutes, and an alignment score corresponding to a predetermined threshold range from 50% alignment to 80% alignment can correspond to the application of treatment wave administration for 10 minutes. It should be understood that any suitable treatment wave administration time and / or administration level can be applied to the subject based on the predetermined threshold range of the alignment score. Additionally, the predetermined threshold range can be any suitable range based on the fully or partially predicted administration session time, any suitable range based on the predicted therapeutic efficacy based on the alignment score, or a combination of both. In some embodiments, the administration controller can receive information including the determined position of the anatomical site 104, the alignment score, the predetermined threshold range, and the control signal from the alignment controller 30. The administration controller can send a signal for the treatment transducer 24 to start administration when the control signal indicates that the anatomical target 104 is aligned and / or the alignment score is within the predetermined threshold range. The loop time for locating the position of the anatomical target 104 within the image frame, determining the control signal, and activating the treatment beam to direct the treatment towards the located anatomical target 104 can be less than 500 milliseconds or any other suitable loop time. In some embodiments, the administration controller can accumulate a measured or estimated value of the total dose (e.g., number of pulses, administration time, integrated administration energy) applied to the anatomical target 104. The administration controller can send a signal when the integrated dose matches the threshold amount of the dose required for therapeutic efficacy. In some embodiments, the administration controller can be housed inside the main controller 80 of the energy application device.

[0067] The alignment controller 30 determines in the determination block 186 whether the desired dose has been completed. If the alignment controller 30 determines that the desired dose has not yet been delivered, the method 160 returns to block 162. If the alignment controller 30 determines that the desired dose has been delivered, the alignment controller 30 can determine in block 190 that the administration session has been completed and send a signal indicating that the administration is complete to the user device.

[0068] The user can be guided throughout the administration session using the application of the user device and / or the display of the energy application device. For example, FIG. 6 is a diagram of an administration user interface 200 for the administration of a treatment wave via a probe of the neuromodulation delivery system 10 according to an embodiment of the present disclosure. The user can be guided by an application including the administration user interface 200 during administration using the energy application device. The administration user interface 200 can display an ultrasonic image formed by the imaging transducer 22 of the probe module 14. The administration user interface 200 can also display an alignment score visualization 152, which includes the current alignment score for the probe module 14, as well as a target alignment score metric 154 and a best alignment score metric 156. In addition, the administration user interface 200 can display a progress visualization 202 corresponding to the progress of the administration throughout the administration session, and displays of the estimated remaining time 206 and elapsed time 204 of the administration.

[0069] At the start of a dosing session, the user can open an application on a user device attached to the energy application device, and the application can display a dosing user interface 200 that displays updated ultrasonic image data generated by the imaging transducer 22 of the energy application device. The dosing user interface 200 can also display a square frame around the anatomical target 104 if the anatomical target 104 is detected within the image data by the alignment controller 30, and can also display a frame line indicating a predefined surrounding area 110 defined in advance by a physician that can be further used to determine alignment with the determined position of the anatomical target 104 within the image data. The dosing user interface 200 can be updated over time based on real-time imaging data generated by the imaging transducer 22 and analyzed by the alignment controller 30. The dosing user interface 200 can also display an alignment score visual image 152 that may include a progress bar corresponding to a percentage alignment score calculated by the alignment controller 30. The alignment score visual image 152 can also include a target alignment score 154 for sufficient dosing. The target alignment score 154 may be predefined by the application based on the subject data and population data regarding the treatment of the subject's condition. In addition, the alignment score visual image 152 can include a best alignment score 156 marker set to the best alignment score achieved over the dosing session. The progress visual image 202 can correspond to the progress of the dosing throughout the session and is based on the alignment score and a predefined dosing time based on a threshold alignment predefined corresponding to the alignment score throughout the dosing session. The progress of the dosing throughout the session can correspond to the number of pulses of the target or the number of pulses or total dosing time until the target number of pulses or dosing time is integrated.

[0070] Furthermore, the energy application device can guide the user based on the image displayed on the user interface 150 and whether or not the anatomical target 104 is within the enclosed area 110 where it is superimposed on the current displayed image. The user interface 150 can also provide updates based on the control signal generated by the alignment controller 30 to reposition and / or adjust the orientation and / or position of the energy application device based on the determined alignment score. The administration user interface 200 can also display the remaining time in the administration session 206.

[0071] With the above in mind, FIG. 7 is a schematic diagram of tracking over time using a treatment transducer 22 having a one-dimensional adjustable focus according to an embodiment of the present disclosure. The energy application device can be capable of adjusting the focus of the treatment transducer 22 over time based on the position of the anatomical target 104 within the image frame generated by the imaging transducer 24. The alignment controller 30 can determine the focus of the treatment transducer 22 such that the treatment beam 106 provides effective treatment to the anatomical target 104 over the treatment session.

[0072] In some embodiments, the treatment transducer 22 enables one-dimensional tracking of the anatomical target 104. For example, the treatment transducer 22 can have the ability to adjust the focus in one dimension aiming in a fixed direction. The focus adjustment can correspond to depth and can be adjusted via electronic focusing control, and the treatment beam 106 can be adjusted through the x-axis, y-axis, and angular adjustment axes. The focus of the treatment transducer 22 may also be adjusted via mechanical control.

[0073] The whole-column controller 30 can detect when the anatomical target 104 enters the focusing range of the treatment transducer 22 and when the treatment beam 106 is aligned with the nominal direction of the anatomical target 104. The system 10 can set the depth of the treatment transducer 22 to perform treatment when the anatomical target 104 is within the steering range of the treatment transducer 22. The system 10 can refrain from applying treatment or abort the application of treatment when alignment with the anatomical target 104 is lost, and when alignment enters within the range of the treatment transducer 22 at a later point, the system 10 can resume the application of treatment.

[0074] For example, at an initial time 210, based on the imaging transducer data 24, the alignment controller 30 can determine that the anatomical target 104 may not be within the focusing range of the treatment transducer 22, and the system 10 can refrain from performing treatment. At a second time 212, the alignment controller 30 can detect that the anatomical target 104 is within the focusing range of the treatment transducer 22, but that the depth needs to be increased to achieve focus. The alignment controller 30 can send a signal to the treatment transducer 22 to increase the depth of the treatment beam 106, and can send a signal to the system 10 to perform treatment so that treatment can be applied to the anatomical target 104 via the treatment transducer 22. At a third time 214, the alignment controller 30 can determine that the anatomical target 104 has entered the focusing range of the treatment transducer 22, but that the depth of the treatment beam 106 may need to be decreased. The alignment controller 30 can then send a signal to the treatment transducer 22 to decrease the depth of the treatment beam 106, and the system 10 can continue the application of treatment. At a fourth time 216, based on the generated image data, the alignment controller 30 can determine that the depth of the treatment beam 106 must be further decreased to correspond to the current position of the anatomical target 104. The alignment controller 30 can send a signal to the treatment transducer 22 to decrease the depth of the treatment beam 106, and the system 10 can continue the application of treatment. At a fifth time 218, the alignment controller 30 can determine that the anatomical target 104 is not within the focusing range of the treatment transducer 22, and can send a control signal to the system 10 to abort the application of treatment. It should be understood that the treatment transducer 22 can adjust the focus in one dimension with respect to the detected position of the anatomical target 104.

[0075] In some embodiments, during administration, the alignment controller 30 can send a signal for looping this adjustment pattern with respect to the subject's respiratory cycle and / or can send an updated signal throughout the treatment wave administration session based on the detected respiratory cycle of the subject. The probe module 14 can include one or more IMU sensors that collect IMU data over time for the subject during the administration session. The IMU sensors can include one or more of an accelerometer, a gyroscope, and a magnetometer, or any combination of suitable sensor types. Using the IMU data, movement of the anatomical target 104 within the subject can be tracked throughout the subject's respiratory cycle. The alignment controller 30 can receive the IMU data and determine changes to the position and orientation of the probe module 14 with respect to the subject's respiratory cycle to provide targeted administration throughout the subject's respiratory cycle.

[0076] With the above in mind, FIG. 8 is a graphical representation 220 of the correlation between the observed portal vein movement and the movement of the energy application device in the ultrasonic image plane based on IMU sensor data according to an embodiment of the present disclosure. The IMU data 224 can be acquired using a probe module 14 (e.g., attached to the IMU) held on the subject surface 100. The probe module 14 can embody a synchronization sequence, which consists of locking the probe module 14 one or more times during one such sequence, during which the subject completes one or more respiratory cycles.

[0077] The graph shows time in seconds on the x-axis and the normalized amplitude for the sensor data on the y-axis. The graph shows the normalized amplitude of the portal vein movement 222 within the ultrasonic image data over time and the IMU sensor data 224 representing the movement of the probe module 14 over time. The graph shows a synchronous series, a normal respiratory cycle consisting of five breaths, and an additional synchronous series. The IMU sensor data is compared with the accelerometer output for the probe module 14. The movement of the portal vein 222 is calculated as the pixel distance of the center of the annotated anatomical site 104 for each image frame with respect to the center of the annotated anatomical site 104 in the received first frame. The portal vein movement data 222 and the IMU sensor movement data 224 are time-adjusted, cross-correlated to be aligned, the DC bias is removed, and they are normalized in the displayed graph.

[0078] The graph demonstrates the utilization of an IMU sensor for tracking the movement of an anatomical target within the body and the predicted path of the anatomical target 104 during the subject's respiration. It should be understood that numerous embodiments may be implemented based on a multi-data fusion algorithm, reduced image complexity based on sensor tracking, or any other suitable tracking method for monitoring the movement of the anatomical target 104 during the subject's respiration. In some embodiments, the IMU position sensor 40 may assist in detecting the movement of the anatomical target 104 and / or detecting the respiratory cycle in the subject.

[0079] With the above in mind, FIG. 9(A) is a schematic diagram of tracking over time using a fixed two-dimensional imaging transducer 24 together with a mechanical locking type treatment transducer 22 with external motion adjustment according to an embodiment of the present disclosure. In some embodiments, the treatment transducer 22 may be of a mechanically locking type via motor control (e.g., axial rotation within the azimuth plane), and may include axial electronic focusing of the treatment transducer 22. An anatomical target 104 within the image plane 108 can be tracked by the alignment controller 30. In addition, the alignment controller 30 can determine when the anatomical target 104 enters the treatment area 102 of the treatment transducer 22 (e.g., the area that becomes the center when the treatment transducer can rotate axially for treatment). The alignment controller 30 can then send a signal to the treatment probe module 14 to mechanically lock towards the anatomical target 104 and / or send a signal to electronically adjust the depth of the treatment beam 106 to focus the treatment beam 106 at the depth of the anatomical target 104. The treatment transducer 22 may be external to the lens 101 of the energy application device, and the treatment transducer 22 can rotate axially using external motion relative to the lens 101. It should be understood that the treatment transducer 22 can adjust the focus one-dimensionally with respect to the detected position of the anatomical target 104. The alignment controller 30 can send a signal to loop this adjustment pattern with respect to the respiratory cycle of the subject and / or send an updated signal throughout the treatment wave administration session.

[0080] For example, at an initial time 230, based on the imaging transducer data 24, the alignment controller 30 may determine that the anatomical target 104 may not be within the treatment area 102 of the treatment transducer 22, and the system 10 may refrain from administering treatment. At a second time 232, the alignment controller 30 may detect that the anatomical target 104 is within the treatment area 102 of the treatment transducer 22, but that in order to treat the anatomical target 104, adjustment is required to focus the treatment beam 106 by axially rotating the probe module 14 to the left in the azimuthal plane and increasing the depth of the treatment beam 106 using axial electronic focusing. The alignment controller 30 may send a signal to the probe module 14 to axially rotate to the left (e.g., using an actuator within the probe module 14) to increase the focusing depth, and may send a signal to the system 10 to administer treatment so that treatment can be applied to the anatomical target 104. At a third time 234, the alignment controller 30 may determine that the anatomical target 104 has entered the treatment area 102 of the treatment transducer 22, but that in order to treat the anatomical target 104, adjustment is required to focus the treatment beam 106 by sending a signal to the probe module 14 to axially rotate to the right in the azimuthal plane. The alignment controller 30 may then send a signal to the probe module 14 to axially rotate to the right, and the system 10 may continue treatment. At a fourth time 236, based on the generated image data, the alignment controller 30 may determine that the depth of focus of the treatment beam 106 may need to be further reduced to correspond to the anatomical target 104, and that the probe module 14 may need to axially rotate to the right. The alignment controller 30 may send a signal to reduce the depth of the treatment beam 106, and send a signal to the treatment transducer 22 so that the probe module 14 axially rotates to the right and the system 10 maintains the application of treatment. At a fifth time 238, the alignment controller 30 may determine that the anatomical target 104 is not within the treatment area 102 of the treatment transducer 22, and may send a control signal to the system 10 to abort the application of treatment. It should be understood that the treatment transducer 22 can adjust the focus with respect to the detected position of the anatomical target 104.The alignment controller 30 can send a signal for looping this adjustment pattern with respect to the respiratory cycle of the subject and / or send a signal updated throughout the entire treatment wave administration session. That is, the alignment controller 30 can send a signal for continuously applying treatment wave administration throughout the entire time during a treatment session such that the alignment score matches the threshold alignment score. It should be understood that the alignment controller 30 can provide any suitable signal based on the determined alignment of the energy application device (e.g., "aligned", "not aligned", "heading towards alignment", "moving away from alignment", and "in the correct position but misoriented", etc.). That is, the signal can be a signal for maintaining the position and / or orientation of the energy application device, a signal for maintaining treatment wave administration, a signal for terminating treatment wave administration, and / or a signal for adjusting the position and / or orientation of the energy application device.

[0081] With the above in mind, FIG. 9(B) is a schematic diagram of tracking control over time using a fixed two-dimensional imaging transducer 24 together with a mechanical locking type treatment transducer 22 with internal motion regulation according to an embodiment of the present disclosure. In some embodiments, the treatment transducer 22 is of a mechanically locking type via motor control (e.g., shaft rotation within the azimuth plane), and may include axial electronic focusing of the treatment transducer 22. An anatomical target 104 within the image plane 108 may be tracked by an alignment controller 30. In addition, the alignment controller 30 may determine when the anatomical target 104 has entered the treatment area 102 of the treatment transducer 22. The alignment controller 30 can then send a signal to the treatment probe module 14 (e.g., an actuator within the probe module 14) to mechanically lock towards the anatomical target 104, and / or send a signal to electronically adjust the depth of the treatment beam 106 to focus the treatment beam 106 at the depth of the anatomical target 104. The treatment transducer 22 may be internal to the lens 101 of the energy application device, and the treatment transducer 22 can rotate about an axis using internal motion with respect to the lens 101. It should be understood that the treatment transducer 22 can adjust the focus in one dimension with respect to the detected position of the anatomical target 104. The alignment controller 30 can send a signal to loop this adjustment pattern with respect to the respiratory cycle of the subject, and / or send an updated signal throughout the treatment wave administration session.

[0082] As discussed above, the probe module 14 can be automatically and / or mechanically steered or focused over time based on the position of the anatomical target 104 relative to the treatment transducer. In a similar manner, the treatment transducer 24 can be mechanically locked and / or focused over time using internal motion to achieve alignment with the anatomical target 104 (reference numerals 240, 242, 244, 246, 248).

[0083] With the above in mind, FIG. 10(A) is a schematic diagram of tracking over time using the two-dimensional imaging transducer 24 coupled to the treatment transducer 22 with external motion regulation according to an embodiment of the present disclosure. The energy application device can include the two-dimensional imaging transducer 24 and the treatment transducer 22, and both transducers 22, 24 are fixed relative to each other and mechanically locked and electronically focused via motor control for tracking of the anatomical target 104 of the subject. The system 10 can lock the transducer assembly 22, 24 including the imaging transducer 24 and the treatment transducer 22 to maintain alignment of the anatomical target 104 throughout the administration. The method of moving the transducer assembly 22, 24 may be external to the lens 101 of the energy application device. It should be understood that the transducer assembly 22, 24 can adjust the focus relative to the detected position of the anatomical target 104. The alignment controller 30 can send a signal for looping this adjustment pattern with respect to the respiratory cycle of the subject and / or send an updated signal throughout the treatment wave administration session.

[0084] For example, at an initial time 250, based on the imaging transducer data 24, the alignment controller 30 may determine that the anatomical target 104 may not be within the treatment area 102 of the treatment transducer 22, and the system 10 can abort the application of treatment. At a second time 252, the alignment controller 30 may detect that the anatomical target 104 is within the treatment range 102 of the treatment transducer 22, but to maintain focus, it rotates axially left in the azimuth plane and uses axial electronic focusing to increase the depth of the treatment beam 106, and a signal for treating the anatomical target 104 is sent to the probe module 14. The alignment controller 30 can send a signal to the probe module 14 to rotate axially left to increase the focusing depth, and can also send a signal for applying treatment to the system 10 so that treatment can be applied to the anatomical target 104. At a third time 254, the alignment controller 30 may determine that the anatomical target 104 has entered the treatment area 102 of the treatment transducer 22, and to focus the transducer assemblies 22, 24, the assembly can be rotated axially right in the azimuth plane to apply treatment to the anatomical target 104. Then, the alignment controller 30 can send a signal to the probe module 14 to rotate axially right, and the system 10 can continue the application of treatment. At a fourth time 256, based on the generated image data, the alignment controller 30 may determine that the depth of the focus of the treatment beam 106 must be further reduced to correspond to the position of the anatomical target 104, and the transducer assemblies 22, 24 can be determined to be able to rotate the probe module 14 axially right. The alignment controller 30 can send a signal to the probe module 14 to rotate axially right and reduce the depth of the treatment beam 106, and the system 10 continues the application of treatment. At a fifth time 258, the alignment controller 30 may determine that the anatomical target 104 is not within the treatment area 102 of the treatment transducer 22, and can send a control signal to the system 10 to abort the application of treatment. It should be understood that the transducer assemblies 22, 24 can adjust the focus with respect to the detected position of the anatomical target 104.The whole-column controller 30 can send a signal for looping this adjustment pattern with respect to the respiratory cycle of the subject, and / or send an updated signal throughout the treatment wave administration session.

[0085] FIG. 10(B) is a schematic diagram of tracking over time using a two-dimensional imaging transducer 24 coupled to the adjustment of a treatment transducer 22 with internal motion adjustment according to an embodiment of the present disclosure. The energy application device can include the two-dimensional imaging transducer 24 and the treatment transducer 22, and both transducers 22, 24 are fixed relative to each other and mechanically locked and electronically focused via motor control for tracking the anatomical target 104 of the subject. The system 10 can lock the transducer assembly 22, 24 including the imaging transducer 24 and the treatment transducer 22 to keep the alignment of the anatomical target 104 in a fixed direction. The method of moving the transducer assembly 22, 24 can be internal to the lens 101 of the energy application device. As discussed above, the treatment transducer can be automatically and / or mechanically steered or focused over time based on the position of the anatomical target 104 with respect to the transducer assembly 22, 24. In a similar manner, the transducer assembly 22, 24 can be mechanically locked and / or focused over time using internal motion to achieve alignment with the anatomical target 104 (reference numerals 260, 262, 264, 266, 268).

[0086] With the above in mind, FIG. 11 is a schematic diagram of tracking over time using a single linear transducer 200 for imaging and treatment according to an embodiment of the present disclosure. The energy application device can include an imaging transducer 22 and a treatment transducer 24, and both transducers 22, 24 are coupled as a single component (e.g., a linear transducer assembly) 200. In other embodiments, the imaging transducer 22 and the treatment transducer 24 that make up the linear transducer assembly 200 may be the same one. The linear transducer assembly 200 can include an electronically steered beam in the azimuth plane for both the imaging element and the treatment element of the linear imaging transducer 200. The figure shows interleaved imaging and treatment via a single linear transducer 200.

[0087] For example, at an initial time 270, an imaging frame 108 based on the imaging transducer 22 at the initial time is shown. The alignment controller 30 can detect at a second time 272 that the beam of the linear transducer is within the treatment range of the anatomical target 104 based on the imaging frame 108 at time 270, and in order to treat the anatomical target 104, a signal can be sent to electronically steer the beam to the left in the azimuth plane to increase the depth of the treatment beam 106 by axial electronic focusing. In some embodiments, a personalized enclosed area 110 affects the delivery of the treatment wave so that no treatment is performed when the position of the anatomical target 104 is detected outside the enclosed area 110. In these embodiments, when the position of the region of interest is additionally within the enclosed area 110, the treatment beam 106 can be focused and steered to the position of the anatomical target 104.

[0088] In addition, the alignment controller 30 can send a signal to the linear transducer assembly 200 to steer left to increase the focusing depth, and can also send a signal for performing treatment to the system 10 so that the treatment can be applied to the anatomical target 104. At a third time 274, the imaging frame 108 can depict that the anatomical target 104 is within the treatment area 102. At a fourth time 276, the alignment controller 30 can send a signal for focusing the linear transducer assembly 200 by electronically steering it right in the azimuthal plane to perform treatment on the anatomical target 104. Next, the alignment controller 30 can send a signal to the linear transducer assembly 200 to steer right, and the system 10 can send a signal for performing treatment. At a fifth time 278, the alignment controller 30 can receive an imaging frame 108 indicating that the anatomical target 104 is within the treatment area 102. At a sixth time 280, the alignment controller 30 can send a signal to the linear transducer assembly 200 to reduce the depth of the treatment beam 106 and can send a signal to electronically steer right, and the system 10 can continue the application of treatment. At a seventh time 282, the alignment controller 30 can determine based on the imaging frame data that the anatomical target 104 is not within the treatment area. It should be understood that the linear transducer assembly 200 can adjust the focus with respect to the detected position of the anatomical target 104. The alignment controller 30 can send a signal for looping this adjustment pattern with respect to the respiratory cycle of the subject and / or can send an updated signal throughout the treatment wave administration session.

[0089] With the above in mind, FIG. 12(A) is a schematic diagram of three-dimensional tracking depicting movement about the azimuth axis according to an embodiment of the present disclosure, and FIG. 12(B) is a schematic diagram of three-dimensional tracking depicting movement about the elevation axis. Both FIG. 12(A) and FIG. 12(B) illustrate aligning with and tracking the three-dimensional target path 106 over time by simultaneously adjusting the energy application device in both the azimuth axis and the elevation axis. In three-dimensional tracking, the entire probe module 14 may remain fixed to the subject surface 100 while undergoing rotation inside the treatment transducer 220 about the elevation axis and the azimuth axis, or the probe module 14 may be moved relative to the subject surface 100 by a gimbal-type (or any other mechanical configuration or linkage for movement) mechanism used to rotate the treatment transducer 220 externally about the elevation axis and the azimuth axis. Rotations of the elevation axis and the azimuth axis are adjusted internally or externally to align with and track the anatomical target 104 along the three-dimensional target path 106. Additionally, in some embodiments, the treatment transducer 220 may have two-dimensional electronic steering and focusing capabilities about the azimuth axis.

[0090] Adjustments about the azimuth axis and elevation axis may include electronically controlling the treatment transducer 220 array and repositioning the treatment transducer 220 over time relative to the anatomical target 104 for the energy applicator using a motor inside or outside the system 10. For example, at an initial time 300, the alignment controller 30 may detect that the anatomical target 104 may not be within the treatment area 102 of the treatment transducer 220 based on the imaging data. At a second time 302, the alignment controller 30 can detect that the anatomical target 104 is within the treatment range 102 of the treatment transducer 220, and can send a control signal for the treatment transducer 220 to rotate left along the azimuth axis via motor control to align with the detected target position 104, and can also send a control signal for performing treatment to the system 10. At a third time 304, the alignment controller 30 can send a control signal for the treatment transducer 220 to rotate right along the azimuth axis and right along the elevation axis via motor control, and can continue to power the system 10 to provide treatment to the anatomical target 104.

[0091] Furthermore, the gimbal assembly may include imaging at a two-dimensional focus along with the electronic treatment, in which the adjustment of the beam focus in two dimensions is possible while involving a slight external tilting motion of the entire probe assembly according to a signal corresponding to the movement of the subject body 100 during respiration. In another embodiment, the gimbal assembly may include a drive system according to a rotating swashplate concept that includes a main rotor shaft that enables the transducer to rock in the azimuth plane and a rotating swashplate with a control rod that enables the tilting and spinning control of the transducer 220. In another embodiment, the gimbal may include a spherical joint and a parallel mechanism with a universal joint that enables the movement of the treatment transducer. It should be understood that any tracking method for tracking the anatomical target 104 of the subject over time may be applied.

[0092] With the above in mind, FIG. 13 is a view of the front of the transducer 20 looking at the surface 100 of the subject. The transducer 20 may include a two-dimensional imaging array 22 and a two-dimensional treatment array 24. In the present embodiment, the two-dimensional imaging array 22 and the two-dimensional treatment array 24 may be capable of three-dimensional steering and / or focusing. Specifically stated, when using three-dimensional focusing and steering, the image plane becomes an image volume, and the treatment area 102 becomes a three-dimensional treatment area. Therefore, the target path 112 is represented in three-dimensional space, and the enclosed area 110 can be represented as a volume. Thereby, it may be possible to steer and / or focus the treatment beam 106 three-dimensionally with respect to the treatment area 102 and the enclosed volume.

[0093] With the above in mind, FIG. 14 is a schematic diagram of an imaging transducer 22 and a treatment transducer 24 of a fixed configuration according to an embodiment of the present disclosure, and is a diagram of a configuration that enables imaging in a two-dimensional plane and steering and / or focusing within the two-dimensional plane. The energy application device may include a treatment transducer 22, an imaging transducer 24, and one or more position sensors 40 (e.g., an inertial measurement unit (IMU) sensor, an optical tracking sensor) that form a fixed configuration. The transducer 20 can be automatically and / or manually steered (e.g., in real time) based on image tracking and analysis based on the subject ultrasonic image and the treatment area (e.g., the area within the ultrasonic image data where the treatment transducer can perform treatment) determined for the desired anatomical target 104 of the subject. In some embodiments, two or more planar arrays within a single unit can also be mechanically steered to improve the treatment range of the energy application device. Thereby, it is possible to keep the anatomical target 104 within the treatment area 102 of the treatment transducer 24 and / or to easily position the anatomical target 104 at the center within the range of the energy application device, providing an effective treatment.

[0094] First, the alignment controller 30 can receive ultrasonic image data (e.g., static image data and / or time-series image data corresponding to the respiratory cycle of the subject). In addition, the alignment controller 30 can receive additional data including sensor data 40 (e.g., inertial measurement unit (IMU) data, optical tracker data). The image data received by the alignment controller 30 can include two-dimensional planar image data from the fixed imaging transducer 22. The imaging transducer can be located at the center of the probe module 14 and can be connected to two treatment transducers 24 at both ends of the imaging transducer 22.

[0095] The imaging transducer 24 can generate image data corresponding to the two-dimensional image plane 108. The alignment controller 30 can determine the position of the anatomical target 104 within this image data by comparing the received ultrasonic image data with pre-acquired image data of the anatomical target 104 and / or pre-acquired image data of the anatomical site surrounding the anatomical target 104. The alignment controller 30 can extract the position of the anatomical target 104 within the ultrasonic image data using the image data and can determine the position of the image data relative to the anatomical target 104. Note that since the ultrasonic image data received by the alignment controller may completely contain, partially contain, or not contain the anatomical target 104, in some embodiments, it should be understood that the alignment controller 30 may not be able to determine the position of the anatomical target 104 within the image data. The alignment controller 30 can also determine the position of the center point within the anatomical target 104 and / or the position of the volume of the subject corresponding to the anatomical target 104.

[0096] Based on the received image data, the alignment controller 30 can determine the level of alignment of the treatment area 102 with the positioned anatomical target 104 and / or an alignment score indicating the alignment (e.g., a percentage alignment score, an average percentage alignment score, an indicator of alignment by yes and / or no). The alignment score can be calculated based on determining the treatment area of the probe module 14 (e.g., the area within the ultrasonic image data where the treatment transducer can perform treatment) and determining whether the anatomical target 104 is within the appropriate range of the treatment area 102. The alignment score can also be calculated based on whether the anatomical target 104 is within the enclosed area 110 (e.g., an area of a specific subject defined by a physician and associated with the position of the anatomical target), to ensure a highly reliable alignment and prevent false positives based on the detection of an inaccurate anatomical target 104 by the alignment controller 30. It should be understood that the alignment score can be calculated using the alignment controller 30 based on any suitable criteria, based on the received image data and past subject data, and / or based on the enclosed area 110 defined by the physician within the subject image data. It should also be understood that two-dimensional tracking requires neither external nor internal motion, and the geometric shape and / or frequency range of each treatment transducer 24 and / or imaging transducer 22 can be optimized for the appropriate imaging and / or treatment needs of the subject.

[0097] This written description discloses the invention, including the best mode, and uses examples to enable any person skilled in the art to practice the invention, including making and using any device or system and performing any incorporated method. The scope of the patentable invention is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements that have non-substantive differences from the literal language of the claims.

Description of Reference Numerals

[0098] 10 System for Neuromodulation 100 Subject's Body 101 Lens 102 Treatment Area 104 Anatomical Target 106 Treatment Beam 108 Image Plane 110 Surrounding Region 112 Target Path 120 Method for Alignment Control of Energy Application Device 150 User Interface 152 Alignment Score Visual Image 154 Target Alignment Score Metric 156 Best Alignment Score Metric 158 160 Method for Delivering Treatment Waves 200 (Figure 6) Administration User Interface 200 (Figure 11) Linear Transducer 202 Progression Visual Image 204 Remaining Administration Time 206 Elapsed Time 210, 230, 240, 250, 260, 270, 300 Initial Time 212, 214 216, 218 Second to Fifth Times 220 (Figure 8) Graph of Correlation between Observed Portal Vein Movement and Movement of Energy Application Device 220 (Figure 12) Treatment Transducer 222 Portal Vein Movement (from Image) 224 Movement Data of IMU Sensor 232, 234, 236, 238 Second to Fifth Times 242, 244, 246, 248 Second to Fifth Times 252, 254, 256, 258 Second to Fifth Times 262, 264, 266, 268 Second to Fifth Times 272, 274, 276, 278, 280, 282 Second to Seventh Times 302, 304 Second to Third Times

Claims

1. A neuromodulation delivery system comprising an energy application device and an alignment controller, wherein the alignment controller receives image data from the energy application device, the image data including an image of the internal tissue based on the current position and orientation of the energy application device with respect to a subject; determines an alignment score of the energy application device with respect to an anatomical target based on the image data; and provides a control signal for holding or changing one or both of the current position or orientation of the energy application device in response to the alignment score. The neuromodulation delivery system is configured to perform operations including these steps.

2. The neuromodulation delivery system according to claim 1, wherein the energy application device includes one or more ultrasonic imaging transducers and one or more treatment transducers disposed within a housing of the energy application device.

3. The neuromodulation delivery system according to claim 2, wherein the position of the energy application device includes an external position of the energy application device with respect to the subject, positions of the imaging transducer, the treatment transducer, or both within the energy application device.

4. The neuromodulation delivery system according to claim 1, wherein the anatomical target is extracted from the image data by determining a position of the image data with respect to the anatomical target, and the image data may fully contain, partially contain, or not contain the anatomical target.

5. The neuromodulation delivery system according to claim 4, wherein the step of determining the position of the image data includes comparing the image data with data of a specific subject, data of a specific population, or both.

6. The neuromodulation delivery system according to claim 1, wherein the alignment score includes a cumulative percentage alignment score including an average of a plurality of alignment scores over time.

7. The step of determining the alignment score according to claim 1 includes determining that the anatomical target detected in the image frame is within a treatment area, and the treatment area includes a range within which the neuromodulation delivery system can perform treatment on the anatomical target.

8. The neuromodulation delivery system according to claim 1. ​ The energy application device includes a position sensor configured to generate position data over time and track the position of the energy application device relative to the anatomical target over the respiratory cycle of the subject, the neuromodulation delivery system of claim 1.

9. The control signal is sent to an automation controller within the energy application device, the automation controller electronically adjusting the position, orientation, or both of the energy application device in response to the control signal, the neuromodulation delivery system of claim 1.

10. The control signal includes a direction signal indicating a direction to move or orient the energy application device to match the threshold range, the neuromodulation delivery system of claim 1.

11. The direction signal includes depth of field (DOF) data and indicates a directional movement relative to the subject in a two-dimensional plane, the neuromodulation delivery system of claim 10.

12. The image data includes two-dimensional planar data, three-dimensional volumetric data, Doppler data, or any combination thereof, the neuromodulation delivery system of claim 1.

13. The image data includes time series data, the neuromodulation delivery system of claim 1.

14. Receiving, via a processor, time series image data from the energy application device at a current position and orientation relative to the subject, the time series image data including images of the subject's internal tissue at the current position and orientation over time; Determining, via the processor, an alignment score of the energy application device relative to the anatomical target over time based on the image data; Comparing, via the processor, the alignment score over a time interval corresponding to the time series image data at the current position and orientation to a predicted alignment score for the time interval at one or both of an additional position or orientation; Providing, based on the comparison, a control signal for holding or changing one or both of the position or orientation of the energy application device A method comprising.

15. The method according to claim 14, further comprising the step of receiving time-series image data at an additional time and determining a predicted treatment wave administration session time based on the alignment score over time corresponding to the time-series image data at the additional time.

16. The method according to claim 14, wherein the time-series image data includes image data over a respiratory cycle of a subject, and the movement of anatomical structures within the subject with respect to the current position and orientation of the energy application device over the respiratory cycle is monitored using the time-series image data.

17. A tracking system comprising one or more processors and a memory, wherein the one or more processors receive, from the energy application device, image data including an image of internal tissue based on the current position and orientation of the energy application device with respect to the subject; receive target image data including an anatomical target and corresponding to the internal tissue of the subject; identify the anatomical target in an image frame of the image data and track the anatomical target in subsequent frames of the image data; determine an alignment score of the energy application device with respect to the anatomical target based on the image data; compare the alignment score with a threshold for the anatomical target; and provide a control signal for holding or changing one or both of the position or orientation of the energy application device based on the comparison of the alignment score with the threshold. A tracking system configured to execute instructions stored in the memory to perform operations including the above.

18. The tracking system according to claim 17, wherein the tracking system receives additional data including one or more of respiratory cycle data, the position of the energy application device over time, or the orientation of the energy application device over time.

19. The tracking system according to claim 17, wherein the control signal includes three-dimensional motion data indicating movement in one or both of the position or orientation of the energy application device, the electronic focus of the treatment beam of the energy application device, or both.

20. The tracking system according to claim 17, wherein the control signal includes two-dimensional motion data indicating a lateral movement direction of the energy application device, an electronic focus of a treatment beam that can be delivered by the energy application device, or both.

Images