Patient-specific neuroregulatory coordination structures

Abstract

Structures and devices are provided to facilitate application of an ultrasound treatment beam to a target anatomical region in a reproducible manner. In certain aspects, adjustable positioning structures are described that allow a generic probe positioning structure to be configured for a specific patient so that the device can be repeatedly used to target anatomical regions, even in non-clinical environments. In other aspects, the probe positioning structure is manufactured to be specific to each patient's anatomy, such that use of the probe positioning structure provides repeatable targeting of the target anatomical region, even in non-clinical environments.

Description

[Technical Field]

[0001] The subject matter disclosed herein relates to targeting and / or dosing a region of interest in a subject via application of neuromodulatory energy to induce targeted physiological outcomes. In particular, the disclosed techniques may be useful in assisting untrained individuals in repeatedly administering treatment to a targeted region. [Background technology]

[0002] Neuromodulation has been used to treat a variety of clinical conditions. However, targeting specific tissues with neuromodulation can be challenging. For example, the precise focus of neuromodulation energy can vary based on an individual patient's anatomy. A particular patient may have different organ size and location compared to other patients based on height, weight, age, sex, clinical condition, etc., which can affect targeting and dose delivery when using various neuromodulation techniques.

[0003] In the context of neuromodulation using ultrasound devices, another common challenge can relate to the difficulty of repeatedly delivering accurate and consistent ultrasound treatments at a prescribed dose in the context of a treatment plan that includes multiple repeat treatments of a treatment area. Furthermore, such treatments can be difficult to administer with minimal training, requiring patients to enter a clinical setting and / or be treated by medically trained personnel for each treatment session. Therefore, patient self-treatment or treatment in a home environment is not typically considered feasible with ultrasound-based neuromodulation therapy.

[0004] For example, when a clinician performs a traditional ultrasound examination, the clinician positions the probe on the body and manipulates it through all degrees of freedom (DOF) until the target scan plane is reached. In contrast, in a patient or self-administered home environment, an untrained user has little or no ability to interpret ultrasound images, even if they are available, and to intelligently maneuver a handheld ultrasound probe to find the target. These challenges make it impractical to self-administer precisely targeted ultrasound-based therapy using traditional approaches, especially in a home environment. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Japanese Patent Publication No. 2021-534914 Summary of the Invention

[0006] The disclosed embodiments are not intended to limit the scope of the claimed subject matter, but rather, these embodiments are intended only to provide a brief summary of possible embodiments. Indeed, the disclosure may encompass a variety of forms that may be similar to or different from the embodiments set forth below.

[0007] In one embodiment, a wearable device is provided. According to this embodiment, the wearable device includes an ultrasound probe and a positioning structure configured to hold the ultrasound probe. The ultrasound probe includes one or more ultrasound transducers. The one or more ultrasound transducers are configured to emit a treatment beam and the one or more ultrasound transducers are configured to emit an imaging beam.

[0008] In another embodiment, a method of configuring a wearable device is provided. According to this embodiment, the wearable device is applied to a subject. An ultrasound probe is coupled to a positioning structure of the wearable device. The ultrasound probe comprises one or more ultrasound transducers. The one or more ultrasound transducers are configured to emit a treatment beam and the one or more ultrasound transducers are configured to emit an imaging beam. One or more of the wearable device, the positioning structure, or the ultrasound probe are adjusted to an anatomical target region of the subject. One or more fitting parameters of the wearable device, the positioning structure, or the ultrasound probe are determined when aligned with the anatomical target region. The one or more parameters are stored for use when the wearable device is subsequently applied to the subject for a treatment session. [Brief explanation of the drawings]

[0009] The following detailed description will be better understood when read in conjunction with the accompanying drawings, in which like characters represent like parts throughout. [Figure 1] FIG. 1 is a block diagram of a neuromodulation delivery system according to an embodiment of the present disclosure. [Figure 2] 1 illustrates a wearable structure suitable for use as an ultrasound probe positioning structure, according to an aspect of the present disclosure. [Figure 3] 10A-10C show further views of a wearable structure suitable for use as an ultrasound probe positioning structure, according to aspects of the present disclosure. [Figure 4] 1 illustrates an example of a probe holder for use with an ultrasound probe positioning structure, according to aspects of the present disclosure. [Figure 5] 5 illustrates a cross-sectional view of the probe holder of FIG. 4 according to an embodiment of the present disclosure. [Figure 6] 1 illustrates an example of a probe cap for use with an ultrasound probe positioning structure, according to aspects of the present disclosure. [Figure 7]1 illustrates a wearable structure suitable for use as an ultrasound probe positioning structure, according to an aspect of the present disclosure. [Figure 8] 1 illustrates a wearable structure suitable for use as an ultrasound probe positioning structure, according to an aspect of the present disclosure. [Figure 9] 1 illustrates a probe module having surface features and suitable for use in an ultrasound probe positioning structure, according to aspects of the present disclosure. [Figure 10] 1 illustrates a wearable structure suitable for use as an ultrasound probe positioning structure, according to an aspect of the present disclosure. [Figure 11] 1 illustrates a wearable structure suitable for use as an ultrasound probe positioning structure, according to an aspect of the present disclosure. [Figure 12] 1 illustrates a wearable structure suitable for use as an ultrasound probe positioning structure, according to an aspect of the present disclosure. [Figure 13] 13A-13C show a series of cartoons illustrating application of the wearable structure of FIG. 12 to a patient, according to an embodiment of the present disclosure. [Figure 14] 1 illustrates a probe holder pocket suitable for holding a probe module relative to an ultrasound probe positioning structure, according to aspects of the present disclosure. [Figure 15] 1 illustrates a process flow showing steps for attaching an ultrasound probe positioning structure according to aspects of the present disclosure. [Figure 16] 10 illustrates iso-contours derived for multiple probe and wearable structure combinations, according to aspects of the present disclosure. [Figure 17] 1 illustrates a process flow showing steps for fabricating a custom fit fixture using surface profilometry and additive manufacturing, according to aspects of the present disclosure. [Figure 18] 1 illustrates a process flow showing steps for manufacturing a custom-fit fastener using a thermoformable material, according to aspects of the present disclosure. [Figure 19] 1 illustrates a process flow showing steps for manufacturing a custom-fit fixture using casting techniques, according to aspects of the present disclosure. [Figure 20]1 illustrates a seal ring according to an aspect of the present disclosure. [Figure 21] 1 illustrates a molded body impression according to an embodiment of the present disclosure. [Figure 22A] 1 illustrates a transducer mounting plate according to an aspect of the present disclosure. [Figure 22B] 10A-10C illustrate additional transducer mounting plates according to aspects of the present disclosure. [Figure 23] 1 illustrates an exploded view of an embodiment of forming a custom fit fastener according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0010] One or more specific embodiments are described below. In an effort to provide a concise description of these embodiments, not all features of an actual implementation are described in the specification. It should be understood that developing such an actual implementation, like any engineering or design project, requires making numerous implementation-specific decisions to achieve the developer's particular goals, including compliance with system-related and business-related constraints. Each implementation may vary. Moreover, it should be understood that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill in the art having the benefit of this disclosure.

[0011] Any examples or illustrations provided herein should in no way be considered as limiting, restricting, or defining any terms in which they are used. Rather, these examples or illustrations are described in terms of various specific embodiments and should be considered merely illustrative. Those skilled in the art will understand that any term in which these examples or illustrations are utilized encompasses other embodiments that may or may not be provided elsewhere herein, and that all such embodiments are intended to be included within the scope of that term or term. Phrases designating such non-limiting examples and illustrations include, but are not limited to, "for example," "for instance," "such as," "e.g.," "including," "in certain embodiments," "in some embodiments," and "in one embodiment."

[0012] As discussed herein, one issue that may arise with treatment techniques involving multiple sessions of targeted ultrasound neuromodulation (e.g., once daily, three times weekly, or once weekly) is the need to provide consistent, accurate registration of the targeted ultrasound neuromodulation for each session. In the context of treatments that can be performed in non-clinical settings (e.g., at home) by individuals (including patients) with little or no medical training, it is desirable for such targeting and registration guidance to be provided in as simple a format as possible. For example, it may be desirable to provide targeting and / or registration assistance without the use of manual guidance based on displayed images and / or while eliminating or minimizing common sources of user error and frustration. Furthermore, because patients' internal conditions and external anatomical conditions vary widely, it may be even more useful to have one registration device suitable for use across a wide range of patient populations, even though a "one size fits all approach" is not feasible. With this in mind, the presently described approaches, structures, and techniques encompass ultrasound treatment registration devices that have customizable elements and / or are individualized to each patient's unique external body shape and size, as well as the shape, size, and location of the patient's internal anatomy. The systems and devices are customizable to address large variations across patient populations, while also being suitable for use in non-clinical settings (e.g., for home use by patients).

[0013] By way of example, in certain embodiments discussed herein, the alignment device is provided as a wearable ultrasound treatment alignment device (e.g., a belt, vest, etc.) that includes configurable sizing or adjustment features, settings, optional interchangeable features, and components and sensors for personalization. Protocols for determining personalized settings and fitting the alignment device to configure a patient for a specific treatment goal (i.e., fitting protocols) are also provided, along with protocols for using the fitted alignment device in treatment sessions conducted in a non-clinical setting, such as at home (i.e., use protocols). After customization, the personalized sizing and / or alignment features enable repeatable positioning on each patient's body, nominally focusing the ultrasound treatment beam toward an internal anatomical target. Such target regions may be portions or subportions of larger organs or structures, such as the hilar region of the liver or the hilar region of the spleen.

[0014] To address the uniqueness of each patient's overall body shape and size, as well as selected external locations on the body, the wearable positioning device provides customizable sizing, adjustable ultrasound probe placement, and the ability to lock the probe in place, achieving a reproducible method and hands-free operation. To address the uniqueness of each patient's internal anatomy, the positioning device may include angle adjustments (e.g., rock, tilt, spin) and configurable depth to nominally aim and focus the treatment beam at the target area. Furthermore, in some embodiments, after the target location is determined, the system may be configured to deliver treatment at that location by electronically steering the treatment beam to the determined location when applying therapy doses. Alternatively, a treatment transducer with appropriate treatment transducer characteristics (e.g., power handling, frequency range, geometry and so forth), and / or appropriate probe cap characteristics (e.g., a probe cap with angle adjustment, attenuation adjustment (e.g., standoff height and / or composition), other geometries or features useful for focusing, shaping, or targeting the beam, etc.) can be selected and employed to direct the treatment beam to a predetermined location when applying a treatment dose.

[0015] Physical features that allow for locking and unlocking the adjustments, as well as baseline target depth, target location in the image plane, baseline image data for comparison, and other sensor readings can also be used when determining personalized settings as part of a fitting session. When used in a non-clinical environment (e.g., at home), the patient or other user can be guided to place the alignment device at a selected external location on the body and secure (e.g., lock) the alignment device in place. Fine adjustments are performed to achieve the desired alignment. The alignment device utilizes prior information stored for the patient, as well as online sensor data and live ultrasound images (if available), to ensure proper fit and probe placement.

[0016] In a further example, certain embodiments discussed herein utilize alignment devices or structures that are custom-manufactured or shaped to fit a patient's external anatomy to ensure repeatable and accurate alignment with internal ultrasound stimulation target regions. Using a custom-manufactured system, even untrained users in non-clinical settings (e.g., patients at home) may be able to safely administer ultrasound stimulation of specific neural target regions over multiple sessions without the assistance of a sonographer or clinician. In particular, such embodiments may employ a custom manufacturing process that reproduces the accuracy of the initial placement of the treatment transducer. This may enable treatment to be administered solely by the patient, such as at home. That is, such custom-manufactured structures may be used to repeatedly position the transducer in a nearly correct position for a given patient, thereby enabling the patient to self-administer ultrasound neuromodulation to an internal target region. This provides improved target alignment compared to unguided positioning without the aid of a custom-manufactured fixation device. In particular, target alignment with a neural target region is improved due to the customized nature of the alignment device, which can utilize a patient's unique anatomical features to fixate the treatment transducer in the correct position and orientation.

[0017] With this in mind, FIG. 1 illustrates an example of a neuromodulation system configured to be used to deliver neuromodulating energy as part of a treatment protocol and that may be used with the alignment and / or positioning devices or structures discussed herein. In particular, FIG. 2 illustrates a schematic diagram of a system 10 for neuromodulation to achieve a neuromodulatory effect, such as neurotransmitter release and / or activation of synaptic components (e.g., presynaptic cells, postsynaptic cells) in response to the application of energy. The illustrated system includes a pulse generator (as part of treatment module 12) coupled to an energy application device (e.g., an ultrasound transducer, as illustrated as part of probe module 14). The energy application device is configured to receive or otherwise generate, e.g., via leads or a wireless connection, energy pulses that are directed to a target region of a subject's internal tissue or organ during use, resulting in a targeted physiological effect.

[0018] In certain embodiments, the energy application device and / or pulse generator can communicate wirelessly, e.g., with a controller that can provide instructions to the pulse generator. As discussed herein, the energy application device can be an extracorporeal device, e.g., operable to apply energy transcutaneously or non-invasively from a location outside the subject's body, and in certain embodiments, can be integrated with the pulse generator and / or controller. In embodiments where the energy application device is extracorporeal, the energy application device can be operated by a caregiver or patient and positioned on the subject's skin or at a location on the skin to deliver energy pulses transcutaneously to desired internal tissues. Once positioned to apply energy pulses to desired sites, system 10 can initiate neuromodulation of one or more neural pathways to achieve a targeted physiological result or clinical effect. In some embodiments, system 10 can be implemented such that some or all of its components can communicate with each other via wired or wireless methods.

[0019] The system 10 may include an evaluation device or logic that evaluates characteristics indicative of the placement and orientation of the energy application device 14. Based on such evaluation, the delivery of therapeutic ultrasound energy may be altered, modulated, or manipulated to automatically achieve a prescribed treatment outcome. As an example, the treatment beam may be electronically guided to the target location when applying a therapeutic dose. Additionally or alternatively, indications or guidance may be provided to the user, such as via audible, visual, or tactile indicators, to provide guidance regarding the placement and / or orientation of the energy application device 12.

[0020] The system 10 provided herein can provide energy pulses according to various modulation parameters as part of a treatment protocol for applying a predetermined amount of energy. For example, modulation parameters can include various stimulation time patterns, ranging from continuous to intermittent. In intermittent stimulation, energy is delivered at a specific frequency for a period of time during a signal-on time. The signal-on time is followed by a period of time during which no energy is delivered, called a signal-off time. Modulation parameters can also include the frequency and duration of stimulation application. The application frequency can be continuous or can be delivered for various periods of time, such as within a day or a week. Furthermore, the treatment protocol may specify the time of day for energy application or a time relative to meals or other activities. Treatment periods to achieve a desired physiological result can last for various periods of time, including, but not limited to, from several minutes to several hours. In certain embodiments, treatment periods with a particular stimulation pattern can last for one hour and be repeated at intervals, such as 72-hour intervals. In certain embodiments, energy can be delivered more frequently, such as every three hours, for a shorter duration, such as 30 minutes. The application of energy can be adjustably controlled according to modulation parameters such as treatment duration, frequency, amplitude, etc. to achieve desired results.

[0021] With the foregoing in mind, additional features illustrated in FIG. 1 are described in further detail below. In particular, aspects and components of the implementation of system 10 are illustrated as modules corresponding to specific functions described above. As noted above, the block diagram of FIG. 1 is as follows: FIG. 1 illustrates a treatment module 12 and a probe module 14 that can be used to perform the treatment functions described herein. While an imaging module 16 is also illustrated, it will be understood that in certain embodiments, such an imaging module 16 may not be present. In such alternative embodiments, analysis performed on image data may be performed on unreconstructed (i.e., raw) image data, or image data that is reconstructed but not displayed. By way of example, treatment management and / or control based on data acquired using an imaging transducer or with imaging module 16 may be based on the reconstructed image (e.g., signatures in the reconstructed image data) or on ultrasound signatures present in the unreconstructed image data.

[0022] Starting with the probe module 14, in the illustrated example, the probe module 14 includes a transducer 20. As used herein, "transducer" refers to any sized and segmented physical structure for converting a primary energy source (i.e., electrical, mechanical, magnetic, etc.) to and / or from ultrasonic energy, and the probe module 14 includes a collection of one or more transducers. As described herein, the geometry of the transducer collection can be a linear (1D) array, a 2D array, or any other suitable geometry of any size, although the imaging and therapy transducers described herein may be independent, partially shared, or fully shared. Depending on the context, "imaging transducer" or "therapy transducer" may be used to refer to a collection of one or more transducers used for related imaging or therapy functions. In other situations, one may speak of an "imaging beam" or a "treatment beam" being generated from a set of one or more transducers, and the sets of transducers used to generate the imaging beam and treatment beam may be independent, partially shared, or fully shared.

[0023] With this in mind, in the illustrated example, the transducer 20 includes both an imaging transducer 22 and a therapy transducer 24. In one embodiment, the therapy transducer 24 can operate at a frequency within the range of 0.2 MHz to 2 MHz (e.g., 0.5 MHz or 2 MHz). The probe module 14 and / or transducer 20 may be selectable or interchangeable in certain implementations to allow a clinician to select the appropriate probe module model or type that best suits the patient or target region circumstances. Select a probe module 14 and / or transducer 20 with the appropriate nominal depth, axial focal position characteristics, power handling, frequency range, angular adjustment, attenuation adjustment, etc. Furthermore, in multi-transducer embodiments, a clinician can customize the probe module 14 by selecting a subset of transducers to operate, enabling coherent summation of the therapy beam at the anatomical target region while minimizing interference from obstructing anatomical structures (e.g., ribs, etc.).

[0024] In alternative embodiments, the transducer 20 may instead comprise a single type of transducer capable of operating at both imaging and treatment frequencies (e.g., 0.2 MHz to 2 MHz during treatment operations and 2 MHz to 12 MHz during imaging operations). Separate transducers are not provided for each type of operation. In such embodiments, a single transducer or transducer type can operate to both provide treatment and acquire imaging-type data. Such a single transducer type approach may be suitable in situations where the target region is shallow and / or high power output is not required. The probe module 14 and / or transducer 20 may be selectable or interchangeable in certain implementations to allow the clinician to select the appropriate probe module model or type that best suits the patient or target region situation. Select a probe module 14 and / or transducer 20 with the appropriate nominal depth, axial focal position characteristics, power handling, frequency range, angular adjustment, attenuation adjustment, etc.

[0025] In the illustrated example, the probe module 14 includes a hardware controller 30, which in the illustrated example includes a microcontroller (MCU) 32 that communicates with a master controller (e.g., processor) 80 of the treatment module 12. A field-programmable gate array (FPGA) 34 communicates with the MCU 32 and with sensors 40 and / or actuators 50 that may be present and associated with the probe module 14. In this configuration, the MCU 32 and FPGA 34 can communicate bidirectionally with components of the master controller 80 to coordinate and / or record the operation of aspects of the probe module 14 or, if present, components directly or indirectly associated with the probe module 14, such as the actuators 50 and / or sensors 40. Various types of sensors may be integrated with the probe module 14 or may be separate and in communication with the probe module 14. By way of example, the sensors 40 may include one or more of an inertial measurement unit (IMU) (which may function as an attitude sensor), a contact force sensor, a tension or strain sensor, etc. As shown in FIG. 1 , one or more sensors 40, if present, may be communicatively coupled to the FPGA 34 or other hardware controller 30.

[0026] With respect to the treatment module 12, as previously mentioned, an implementation of the treatment module 12 may include a master controller (e.g., processor) 80, which may itself include or execute various sub-modules or routines that may be stored in a memory structure 84. For example, the master controller 80 may include or execute modules or routines that provide functionality such as an image streamer and remote control, artificial intelligence (AI) anatomical structure recognition and tracking, a guided dosing engine, a user interface, supporting analytics, a data logger, etc.

[0027] Like the probe module 14, in certain embodiments, the treatment module 12 can include a hardware controller 86, which can include its own MCU 88 and FPGA 90. While shown as separate modules for purposes of illustration and description, in practice the probe module 14 and treatment module 12 may actually be the same (i.e., a unitary structure or device configured to perform the functions of both a treatment module and a probe module, as described herein). With this in mind, although described separately herein, in practice the hardware controllers 30 and 86 may be implemented as a single hardware controller. In the illustrated example, the MCU 88 is shown in communication with the master controller 80 and its components and modules. The FPGA 90 communicates with and / or controls other components of the treatment module 12, such as a therapy pulser receiver 92 (shown in communication with the therapy transducer 24 of the probe module 14), safety circuitry 94, and / or power supply. In practice, the master controller 80, in conjunction with the hardware controllers 86, 30, can control the operation of the treatment module 12 and the probe module 14, including performing therapy application according to the processes and structures described herein. Also, as shown in FIG. 1 , one or both of the master controller 80 and / or the hardware controller 86 may communicate with one or more memory structures 84 (e.g., volatile or non-volatile memory, firmware structures, mass data storage, etc.). As will be appreciated, code or executable routines for performing operations (e.g., treatment procedures or protocols) may be stored in the memory 84 for use by other components. Additionally, one or more configurable parameters (e.g., system settings, imager settings, sensor settings or thresholds, etc.) may be stored in the memory structure 84, such as by a user who configured or calibrated the system 10 for use with a particular patient for each treatment protocol. Additionally, the memory structure 84 may be used to store data (e.g., image data) acquired or generated as part of a treatment procedure, such as for later retrieval and evaluation.

[0028] In the illustrated example, the imaging module 16 is also shown as a component of the overall system. If present, such a module may control or monitor the operation of the transducer 20 (e.g., the imaging transducer 22) to control the generation, collection, and / or processing (e.g., reconstruction) of imaging data. In the illustrated example, the imaging module 16 is also shown as communicating with a master controller 80 for the treatment module 12, which may control the operation of the imaging module 16 or respond to feedback and data from the imaging module 16. Like the probe module 14 and the treatment module 12 described above, the imaging module 16 is shown in FIG. 1 as a separate module. This is done for ease of illustration and explanation of functional concepts. However, as with the previous examples, the imaging module 16 may actually be identical to one or both of the probe module 14 and the treatment module 12 (i.e., it may be an integrated structure or device configured to perform the combined functions of the imaging module and one or both of the treatment module and the probe module, as discussed herein).

[0029] With the foregoing system description in mind, as context, the present technology relates to an image (or non-reconstructed image data) guided ultrasound therapy system. In certain embodiments, a device or structure that provides targeting and / or alignment assistance without manual guidance is used in conjunction with the system 10 discussed with respect to FIG. 1. Such targeting and alignment devices may include customizable elements and / or may be individualized to each patient's unique external body shape and size, as well as the patient's internal anatomical shape, size, and location. The systems and devices are customizable to address large variations across patient populations, while also being suitable for use in non-clinical settings (e.g., for home use by patients).

[0030] Described herein are various exemplary embodiments of targeting and positioning devices, collectively referred to herein as probe positioning structures. When used, these devices can facilitate the application of safe and effective ultrasound neuromodulation therapy, including in non-clinical settings and / or when operated by untrained users (e.g., patients themselves or other individuals without clinical or medical training). Accordingly, some of the presently described embodiments are designed or configured for ease of use by the end user.

[0031] By way of context, conventional ultrasound scans exhibit a high degree of variability across patient populations. Trained sonographers adjust probe placement on the body, probe angle, and system settings to accommodate this patient variability and obtain targeted diagnostic images. As described herein, the present probe positioning structure helps avoid such manual manipulation (thereby facilitating placement and use by untrained individuals) and enables personalized, easy, and reproducible probe positioning and hands-free operation during a treatment session.

[0032] With this in mind, in a first example of an implementation of a probe positioning device in the form of a wearable structure 100, as shown in FIG. 1, and referring to FIG. 2, a body-worn, adjustable probe positioning structure is shown that is suitable for hands-free use (i.e., neither the device nor the attached probe need be held during operation). In this example, the probe positioning structure may be provided as a wearable belt 106 (as shown), a vest, a harness, or the like, although other wearable devices or rigs (suitable for appropriate body positioning) may also be used. With this in mind, the probe positioning structure in this embodiment is at least initially adjustable (i.e., upon first use or through a calibration or fitting operation). In the illustrated example of a belt 106, a user can adjust or fit the belt 106 by donning the belt 106 and adjusting one or more fitting mechanisms 112 provided on the wearable structure 100 (e.g., by tightening or loosening one or more straps or other adjustable features). When worn and attached in this manner, the belt 106 (or equivalent wearable structure 100) can be worn and used in a hands-free manner during a treatment or treatment session.

[0033] The one or more fitting mechanisms 112 may include, but are not limited to, fastening and / or tightening mechanisms such as clips 114, locks, adjustable straps 116, ratchets, pull cords, lace tensioning systems, or inflatable features. Such fastening and / or loosening features may be either manual (i.e., user-operated or adjusted) or automatic (e.g., automatically adjusted utilizing a motorized mechanism in response to sensors and / or image data), as described herein. With regard to the fit of the wearable structure 100, the wearable structure 100 may be provided in multiple sizes (e.g., small, medium, large, extra large), and the size that most closely matches the patient may be selected prior to adjustment. Alternatively, the wearable structure 100 may be provided in a single size (i.e., one size fits all), and the fitting features 112 may be relied upon solely to adjust or tailor the fit of the probe positioning structure to each patient.

[0034] 2, a probe 14 (e.g., a central dual-mode imaging / therapeutic ultrasound probe) is shown attached to a coupling structure or feature 140 (e.g., a probe clip or connector) of the wearable structure 100. Other probe configurations (e.g., non-central and / or multiple transducer configurations) connected to or disposed on the wearable structure 100 are also possible.

[0035] One or both of the wearable structure 100 or the probe 14 may include sensors that can be used to measure and guide the fitting of the wearable structure 100. As one example, the probe 14 and / or the wearable structure 100 may include an inertial measurement unit (IMU) 150 as a posture sensor. Such an IMU 150 may be embedded within the probe 14 and employed during a fitting session to measure the orientation of the device (e.g., the probe) appropriate for the treatment or therapy session (which may correspond to the patient's posture). Measurements from the IMU 150 may then be used during a dosing or treatment session to ensure that the patient's posture corresponds to that expected based on the fitting session. As a further example, a contact force sensor 152 may be provided on the patient-facing surface of the probe 14, for example. In such an example, the contact force sensor 152 may be used during the fitting session to measure contact force, which provides a measurement or guidance for adjustment of the z-dimension, which is the direction from the probe face toward the patient (i.e., toward the patient). Measurements from the contact force sensor 152 can then be used in a dosing or treatment session to ensure that the proper contact force is present before a dose is applied. As a further example, a tension or strain sensor 156 can also be provided, such as at a connection point on the belt 106. In such an example, the tension sensor 156 can be used in a fitting session to measure a baseline belt tension when the belt 106 (or other wearable structure 100) is properly fitted to the patient. Measurements from the tension sensor 156 can then be used in a dosing or treatment session to ensure the proper tension is present before a dose is applied.

[0036] Turning to FIG. 3 , a further example of a wearable structure 100 in the form of a belt 106 is provided for purposes of illustrating possible manual adjustment mechanisms in the x and y directions (i.e., along the surface of the patient in vertical and horizontal directions, as opposed to toward the patient in the z dimension). In this example, the belt 106 can be attached to the patient using mechanisms such as those described with respect to FIG. 1 . A probe 14 having a patient-facing transducer 20 is provided on the belt 106, either as an integral feature of the belt 106 or as a wearable (e.g., clippable) accessory. For example, as described herein, the probe 14 (which may be a central dual-mode imaging / therapeutic ultrasound probe) may be attached to a docking feature (e.g., a probe clip or connector) of the wearable structure 100, here the belt 106. In FIG. 3 , the belt 106 is shown from a perspective view, with the patient-facing surface of the probe 14 visible through an acoustic window 180 provided in the belt 106.

[0037] In one embodiment utilizing the wearable structure 100 as shown in FIG. 3 , a belt 106 can be applied to the patient and the probe 14, and the associated one or more transducers 20 can be moved in the x and y dimensions relative to an acoustic window 180 of the belt 106 to achieve probe alignment. In this particular embodiment, a user can adjust the position of the one or more transducers 20 by moving the probe 14 in the x and y dimensions relative to the acoustic window 180 while the system 10 analyzes simultaneously acquired ultrasound image data. In one embodiment, the system 10 guides the user (e.g., using optical, audible, and / or tactile feedback or cues) to move the probe 14 in the x and y dimensions relative to the acoustic window 180 to achieve alignment with the target region. Alternatively, in another embodiment, the user randomly moves the probe 14 and the associated one or more transducers 20 within the acoustic window 180 until the system 10 indicates that alignment with the target region has been achieved. The instructions may be binary yes / no, and the system 10 may use optical, auditory, and / or tactile cues or feedback (e.g., by beeping faster or louder (or similar visual feedback) as the user receives them) to guide them through the random actions.

[0038] Similar to the example described with respect to Figure 2, the belt 106 of Figure 3 may also be fitted with sensors 40 that can be used to measure and guide the application of the belt 106. By way of example, the sensors 40 may be employed to measure and / or provide feedback regarding belt tightness, contact force, posture, and / or body position.

[0039] In further embodiments, the belt 106 may not allow or limit adjustment of the transducer 20 in the x and y dimensions after the belt 106 is secured in place. In such embodiments, x and y alignment of the transducer 20 may occur before locking down (i.e., securing) the belt 106 for a treatment session. For example, a user (e.g., a patient) may position the belt 106 (or other positioning device) in the appropriate overall position on the patient (e.g., without tightening or locking the belt 106 in place). The user may then move or adjust the positioning of the probe 14 or the wearable structure 100 (e.g., the belt 106) to which the probe 14 is attached, such as via a feedback or notification mechanism as described above, until alignment with the target area is achieved. Once alignment with the target area is achieved, the user (e.g., a patient) may tighten or secure the wearable structure 100 to lock the probe 14 in place for a treatment session.

[0040] In another embodiment, the wearable structure 100, such as the belt 106, may include a locking mechanism (e.g., a quick-lock mechanism) that a clinician can utilize to lock or secure the position and orientation of the belt 106 during a fitting session. Once the proper position and orientation is determined and the probe is re-engaged or attached to the belt 106, the probe 14 is again moved. In such an embodiment, the locking mechanism, once locked, prevents or limits manipulation or adjustment of the probe's position and orientation settings, as specified by the clinician, even when the probe 14 is disengaged from or removed (e.g., unclipped) from the probe positioning structure 100, such as when not in use. In this way, users other than the clinician can prevent or limit the ability to reposition or reorient the probe 14 when attached to the wearable structure 100 after the fitting process.

[0041] In one such example, during an initial fitting or calibration session, a clinician manually adjusts the fit of the belt 106 and the probe 14 coupled to the belt 106 relative to the acoustic window 180 to align the transducer 20 of the acoustic window 180. The probe 14 is aligned with the target area. During fitting, the clinician can also adjust the fit of the probe 14 in the z-dimension for optimal probe placement relative to the target area and to ensure good acoustic contact with the patient during fitting. The fitting session can also fix the orientation of the probe 14 when secured to the belt 106 (as opposed to the x-, y-, and z-dimensional positioning of the probe) by adjusting one or more of the roll, pitch, or yaw (e.g., swing, tilt, rotation, etc.) of the probe 14 when attached to the belt 106 so that it is calibrated or locked into the appropriate (e.g., optimal) scan plane with respect to the target area. Once the position and orientation of the probe 14 is determined to be aligned with the target area, a locking mechanism can be set or locked to align the probe 14 with the target area when the probe 14 is coupled to the wearable structure 100. The wearable structure 100 is applied to the patient and secured.

[0042] In this manner, once the wearable structure 100 and probe 14 are adapted for a subsequent treatment session, the user (e.g., a patient) can apply the wearable structure 100 and probe 14 during the treatment session to ensure the probe 14 is properly positioned and aims to apply treatment. In certain embodiments, the user may be permitted to adjust the position of one or more transducers 20 with limited ability by moving the probe 14 in the x, y, and / or z dimensions relative to the acoustic window 180. The system 10 analyzes simultaneously acquired ultrasound image data. That is, in some embodiments, if a lockout mechanism is used, the range within which the user can adjust the position and / or orientation of the attached probe 14 may be limited, essentially allowing the user the ability to fine-tune or optimize the position and orientation of the probe 14 within the limits set by the locking mechanism. In one embodiment, the system 10 guides the user (e.g., using optical, audible, and / or tactile feedback or cues) to move the probe 14 in the x and y dimensions relative to the acoustic window 180 to obtain final alignment with the target area.

[0043] While the foregoing description relates to various aspects of a generalized probe placement device design and related fitting concepts, various exemplary design and use cases are provided below to illustrate real-world or practical implementations or aspects of such approaches. By way of example, and with reference to FIG. 4 (external view) and FIG. 5 (corresponding cross-sectional view), an example embodiment of a probe holder 200 suitable for coupling to a wearable structure 100 (e.g., using coupling features 140 in an acoustic window 180) is shown. The illustrated example of probe holder 200 may allow manual adjustment (such as by a clinician performing an initial fitting or calibration or by a non-clinical user) not only in the z-dimension perpendicular to the patient's skin surface and / or the angle or tilt of probe 14 (i.e., angular adjustment), but also with respect to the x- and y-dimensions (i.e., x- and y-dimensional positioning within acoustic window 180 of wearable structure 100 and / or placement of wearable structure 100 itself). Additionally, the illustrated embodiment provides a locking mechanism for locking both the z-axis positioning, angular positioning, etc., once attached to the patient.

[0044] The probe carriage frame 208 is coupled to the z-axis rails 210 via a z-axis carriage 212 so that the probe modules 14, when mounted on the probe carriage frame 208, can be moved in the z-dimension (i.e., toward or away from the patient). As shown more clearly in the cross-sectional view of FIG. 5, a spherical joint 220 is also provided that resides partially within a recess in the z-axis carriage 212 and connects to the probe carriage frame 208. In this example, the spherical joint 220 allows the probe carriage frame 208 (and the mounted probe modules 14) to swing, tilt, and / or rotate based on the range of motion provided by the spherical joint 220.

[0045] A spherical joint clamp 222 is provided to secure the spherical joint 220 relative to the z-axis carriage. In the illustrated example, the spherical joint clamp 222 is connected to a clamp lever 226 that can be manually actuated between a locked and an unlocked position. In the illustrated example, the clamp lever 226 is shown along the side of the z-axis rail 210 and is coupled to an extension that passes through the z-axis rail 210 and the z-axis carriage 212 to engage the spherical joint clamp 222. By moving the clamp lever 226 from the unlocked position to the locked position, a user can simultaneously lock the movement of the z-axis carriage 212 and the spherical joint 220 to rotate, lock, and tilt the probe carriage frame in the z dimension.

[0046] Regarding the focus in the z dimension, while moving and fixing the probe module 14 in the z dimension is one approach to achieving the appropriate focal plane, it should also be understood that selecting the appropriate probe module is important. Selecting a probe module as shown in FIG. 14 from a set of available probe modules can also be part of achieving the appropriate z focus. As an example, a set of available probe modules with appropriate treatment transducers (e.g., single-element transducers) can each have a different, respective unique z-dimension focus (e.g., 6 cm, 8 cm, 10 cm, etc.). During a fitting session, a clinician can select a probe module 14 from the set of available probe modules that best matches the depth of the target region for each patient. The selected probe module with the unique z focus can be combined with the probe holder 200 for installation and / or calibration.

[0047] Additionally, each probe module 14 from the available set may (or alternatively) differ with respect to the angle or orientation of the probe module 14 relative to the patient. As shown in FIG. 6 , the angular orientation of each probe module 14 relative to the patient (i.e., directing the focused beam to the correct x-position corresponding to the target region in the focal plane) may be determined by a probe cap 204 to which the probe module 14 is attached. Such probe caps 204 may be permanently attached to the probe module 14 or may be removable and interchangeable. Different probe caps 204 may be associated with different angular orientations (e.g., −20°, −10°, 0°, 10°, 20°, etc.), such that the angular orientation of the probe cap 204 is determined by the selection of the probe cap 204. As an example, interchangeable probe caps may adapt the angle at which the probe module 14 contacts the body surface, reducing the rocking or tilt angle relative to the patient or reducing the size of the acoustic aperture to optimally fit the patient's access zone and anatomical target. In addition to, or instead of, this angular adjustment, the probe cap 204 may be differentiated and selected based on attenuation characteristics or adjustments (e.g., standoff height, standoff composition, etc.), shape and / or focusing features useful for beam focusing, shaping, or other targeting.

[0048] 4 and 5, the probe holder 200 includes a frame 250 that serves as an attachment interface to a belt, vest, or other positioning structure to form a probe positioning assembly. In this example, the z-axis rail 210 is attached to the frame 250 (e.g., via rail attachment points) so that components connected to the z-axis rail 210 (e.g., the remainder of the probe holder 200) are attached to the frame 250. In this example, the frame 250 includes attachment points 254 (e.g., belt rail attachment points) that can engage with complementary structures (e.g., anchor points or mounting rails) on a positioning device such as a belt. For example, the attachment points 254 on the frame 250 can engage or secure to complementary attachment points on a mounting rail provided on a belt or vest of the probe positioning structure.

[0049] With the probe holder 200 in mind, as generally described, that may be suitable for incorporation with the wearable structure 100, the following three examples illustrate different approaches to implementing a probe positioning structure. It should be understood that the following examples are merely illustrative of different concepts and are not intended to limit the manner in which a probe positioning structure may be provided. Instead, the following examples are merely intended to provide a context and real-world framework to better illustrate and explain how such probe positioning structures may be implemented and used. As will be appreciated, to the extent that the various wearable structure 100 implementations discussed herein have appropriate size and / or flexibility, such probe positioning structures may be configured to fit into or otherwise be stored in a compartment within the treatment module 12. In this manner, the wearable structure 100 may be conveniently stored with the device with which it is used.

[0050] 7 and 8 , a wearable structure 100 in the form of a belt 106 having one or more tensioning features and easy donning and doffing is shown. In one embodiment, the belt 106 may be a “one size fits all” belt that can be customized or configured to fit different body sizes or weights. For example, an embodiment having the specific fitting and / or adjustment features shown in FIG. 7 and highlighted in FIGS. 8 and 9 may be initially configured or fitted in a fitting session and then applied by a clinician or non-clinician for a treatment session. As will be appreciated, in practice, the belt 106 may be oriented or positioned to hold the probe module 14 in a clinically appropriate position and orientation; thus, the probe module 14 may be held on the front, back, or side of the patient. In certain embodiments, for ease of use by non-clinicians, the probe module 14 may include a power on / off button or switch 246 on its outward-facing surface for easy activation.

[0051] As an example, the belt 106 can be secured and released via a magnetic closure 256, which is simple and quick to operate. Adjustment can be achieved using a pull-string lace tightening system, shown in FIGS. 7 and 8 , which includes a drawstring 240 with a pull handle 242 to control the separation provided by one or more lace or webbing portions 244 of the belt 106, thereby allowing the belt 106 to be tightened or loosened. As an example, in a fitting session, the belt 106 can be secured via the magnetic closure 256, etc., and once secured, the pull handle 242 can be tightened to fit the belt 106 to the patient in a manner that properly positions and orients the probe module 14. The drawstring 240 and pull handle 242 can then be secured by a cable or cord fastener 252 to prevent adjustment of the fit. The cable fastening features 252 may also be used to secure other cables or strings, such as the probe module cable 260, that extend between the treatment module and the probe module 14.

[0052] In certain embodiments, the probe module 14 may be configured to communicate with a treatment module or a home electronic device (e.g., an application running on the patient's mobile phone) to facilitate electronic troubleshooting or alignment. As an example, once the worn belt 106 and probe module 14 are applied to the patient, the patient can utilize an application on the mobile phone to perform an automatic adjustment or alignment process that electronically aligns and guides the treatment beam to account for small misalignments.

[0053] This is shown in FIG. 8 along with other aspects that facilitate adjustment and / or fitting to a patient. For example, in FIG. 8, pull handle 242 and pull string 240 are shown in an operable configuration such that pulling pull handle 242 tightens webbing portion 244. Additionally, belt 106 is shown as being trimmable to remove excess length 270, such as during a fitting operation. For example, in embodiments in which belt 106 is a "one size fits all," belt 106 may include excess length 270 that can be cut and removed by the fitting clinician during fitting. Clips 272 are secured to the belt to secure the ends and cover any cut ends.

[0054] 9, in a further refinement, the probe module 14 may include anti-slip protrusions (e.g., bumps, bumpers, "feet") on the patient-facing surface to limit or eliminate slippage when the probe module 14 is positioned relative to the patient. As an example, the protrusions may press against the patient to inhibit movement of the probe module 14 when the attached belt 106 is applied to the patient.

[0055] 10 and 11 , an example of a wearable structure 100 in the form of a belt 106 employing auto-tensioning is shown. As with the previous example, the belt 106 may be a “one size fits all” belt that fits different body sizes, or it may be a belt with different body sizes (e.g., one, two, or three sizes). As described in more detail below, an auto-tensioning process may be used to fit the belt 106 to the patient after application of the belt 106. As will be appreciated, in practice, the belt 106 may be oriented or positioned to hold the probe module 14 in a clinically appropriate position and orientation, and thus the probe module 14 may be held against the front, back, or side of the patient.

[0056] In the illustrated example, the belt 106 may be applied or attached to the patient using a hook-and-loop fastening system 280 along one side, although other fastening mechanisms may be used as appropriate. Once applied to the patient, an automated process may be used to activate an inflatable tightening system integrated with the belt 106 at a predetermined tension for the patient. The predetermined tension may be configured or set by a clinician as part of the initial fitting process and / or may be predefined based on standardized tension parameters. As part of the tensioning process, one or more sensors (e.g., contact force sensors, tension or strain sensors) provided on one or both of the probe module 14 or the wearable structure 100 (e.g., the belt 106) may be used to provide: Transmitting strain or force measurements to a processor-based device that executes the automated tensioning process. By way of example, the processor-based device may be the treatment module 12, the probe module 14, or a separate device such as a computer, tablet, or mobile phone 290, as shown in FIG. 11, or as described below.

[0057] 11, internal structural components 292, such as spring steel components (shown in shading) of the belt 106, can be provided to maintain the round (e.g., circular or oval) shape of the belt 106 and facilitate easy attachment and detachment of the belt 106. For example, such structural components 292 can help maintain the shape of the belt 106 and allow for easy separation for attachment and detachment of the belt 106.

[0058] Additionally, the belt 106 may include bladders or other inflatable portions that can be inflated to varying degrees to achieve a prescribed or defined fit on the patient (based on contact force or tension). For example, as discussed above, one or more sensors (e.g., contact force sensors, tension or strain sensors) on one or both of the probe module 14 or the wearable structure 100 (e.g., the belt 106) may be used to provide: sending tension or force measurements in real time to an executable tensioning routine that controls the inflation of the inflatable portion, causing the tensioning routine to continue inflating the inflatable portion until a predetermined tension or contact force is reached; once the prescribed tension or contact force is reached, the probe module 14 is further electronically aligned (if necessary) and treatment is administered.

[0059] In the illustrated example, a processor-based device in the form of a mobile phone 290 is shown that can implement or control the tensioning routine and operation of the probe module 14 and / or treatment module 12. The mobile phone 290 can store and execute an application that can initiate and control inflation of the belt 106 and / or initiate a treatment session once inflation is complete. Additionally, between the steps of inflating the belt 106 and applying the treatment, a process running on (or controlled by) the mobile phone 290 can perform an auto-tuning or alignment process that can electronically align and direct the treatment beam to account for small misalignments.

[0060] 12, 13, and 14, an example of the wearable structure 100 in the form of a vest 300 is shown, which provides greater patient coverage and / or greater control of probe position. The vest 300 may be provided in multiple sizes (e.g., XS, S, M, L, XL) to accommodate different body sizes or types. As will be appreciated, in practice the vest 300 may be oriented or positioned to hold the probe module 14 in a clinically appropriate position and orientation, and thus may hold the probe module 14 on the front, back, or side of the patient.

[0061] In the illustrated example, the wearable structure 100 in the form of a vest 300 includes one or more tensioning mechanisms to facilitate application to each patient of a given vest 300. For example, the implementation shown in FIG. 12 may be initially configured or fitted in a fitting session and then applied in a treatment session by a clinician or non-clinician.

[0062] By way of example, the vest 300 can be secured and released via a magnetic closure that is simple and quick to operate. Alternatively, or additionally, one or more zippers 306 can be provided to secure the vest 300 during application. In one embodiment, adjustment can be achieved using a drawstring tightening system, shown in FIG. 12 as including a drawstring or strap 240 having a pull handle 242 to control the separation provided by one or more lace or webbing portions of the vest 300. By way of example, tightening the pullstring or strap 240 via the pull handle 242 can tighten the pull webbing portions of the vest 300 around the patient's abdomen and / or shoulders and can be utilized to tighten (or loosen) portions of the vest 300.

[0063] In the illustrated example (as shown in FIG. 14 ), the probe module 14 fits within a pocket 310 or other holder to contact the patient's skin 304. By way of example, the pocket 310 may include a bracket or other structural feature that the probe module 14 engages with when inserted into the pocket 310. The pocket 310 may be constructed to ensure tension between the probe module 14 (during insertion) and the patient (i.e., when the probe module 14 is inserted into a fitted vest, the probe module 14 is forced into the patient's body). When within the pocket 310, the cord 260 associated with the probe module may be routed through the vest 300 (e.g., through a layer or passageway formed in the vest 300).

[0064] Referring to FIG. 13 , a series of diagrams illustrating an example of a patient donning the vest 300 and inserting the probe module 14 into the integrated pocket 310 are shown. As shown in this example, the patient first dons the vest 300 over their head (top left: pull-on). The sides of the vest 300 are then secured, such as with magnetic closures, and the zipper 306 is used to secure the vest 300 vertically (i.e., from top to bottom) (top right). The drawstrings 240 can be pulled to tighten the vest 300 around the patient's abdomen and / or shoulders (bottom left). The probe module 14 can then be secured in the vest's pocket 310 (bottom right).

[0065] In certain embodiments, as shown in FIG. 12 , the probe module 14 can be configured to communicate with a processor-based device (e.g., a mobile phone 290) that can implement or control the operation of the probe module 14 and / or the treatment module 12. 290 can store and execute applications that facilitate electronic troubleshooting or adjustments. As an example, once the fitted vest 300 and probe module 14 are applied to the patient, the patient can utilize an application on the mobile phone to perform an automatic adjustment or alignment process that can electronically align and direct the treatment beam to accommodate small misalignments.

[0066] Some of the above-described implementations refer to a fitting operation or session for adjusting the probe positioning structure, as discussed herein. Such a fitting session can be used for the initial setup of the probe positioning structure for each patient and treatment protocol. In such a fitting session, patient-specific physical adjustments, imaging parameters, and access locations for the wearable structure 100 are all determined and recorded, so that the wearable structure 100 can be reconfigured for that patient at any time. In contrast to a fitting session, a dosing session is the normal mode of operation (i.e., application of treatment) in which the patient or another non-clinician operates the fitted wearable structure 100 themselves, such as at home. In one example of such a dosing session, the patient wears the attached wearable structure 100 (e.g., a personally worn device) with system guidance until alignment of the ultrasound image with the target is found. The system then operates in a hands-free, autonomous manner until the treatment dose is completed.

[0067] 15, example steps performed in a fitting session are shown in the form of a process flow. It should be understood that the described steps and their order are provided for illustrative purposes only, and that in practice, certain actions may be performed in a different order or in parallel with one another. Indeed, the described steps and their order are provided solely for illustrative purposes, to provide an example of a real-world context and implementation, and should not be considered limiting.

[0068] 15 , in an implementation in which the wearable structure 100 is provided in multiple stock sizes or types, the clinician first selects a size (e.g., small, medium, large) or type (belt, vest) of the wearable structure 100 (step 350) and fits it to the patient. Then, using the selected wearable structure 100, basic fitting steps may be performed on the patient (step 354). As an example, the clinician may secure the wearable structure 100 to the patient (e.g., strap a body-worn device to the patient) and adjust one or more features of the device to achieve a basic fit. Next, the probe module 14 is applied (step 358) and an initial probe adjustment is performed (step 362). By way of example, initial probe calibration may include, but is not limited to, a clinician manipulating the probe module 14 in six degrees of freedom (x, y, and z position, rocking, tilting, and rotation (e.g., roll, pitch, and yaw)) while the patient is breathing normally to identify the target area and position the access point or window (i.e., x, y location) on the patient's body. As part of this process, the clinician may select or exchange components of the probe module 14 (e.g., the selected transducer 20 and / or probe cap 204) or the probe module 14 itself for best alignment, depth, and power delivery. The target area may be set within system-wide constraints, such as angular range. By way of example, at this stage the clinician may select the appropriate probe SKU (stock-keeping unit) or part that best fits the determined configuration. Examples of this approach may include selecting interchangeable treatment transducers that adjust the nominal depth, frequency, power delivery, and / or axial focus location, and / or interchangeable probe caps that change the angle of the probe module 14 to reduce the required lock or tilt angle.The treatment beam can be attenuated or shaped to fit the body surface, and the acoustic aperture size can be optimally adapted to the patient's access zone and anatomical target.

[0069] Once these initial steps are complete, a tensioning step can be performed (step 370). During this step, the clinician can tension the wearable structure 100 (e.g., belt or vest) to lock the access points (x, y positions) in place. A final probe positioning step can be performed after tensioning (step 374). During this step, the clinician can perform fine adjustments in four degrees of freedom (z position, lock, tilt, spin) to find the optimal probe position for the treatment session. Such optimal probe position will typically be based on acceptable target alignment for a sufficient percentage of the respiratory cycle (e.g., 60%, 70%, 80%, etc.). Such target alignment optimization can be based on, but is not limited to, maintaining the target in the center of the field of view, the target within the imaging plane, the target within the electronic steering capabilities of the probe module 14, etc.

[0070] Once final probe positioning is performed, the clinician may lock the probe module 14 in place (step 378). The clinician may then release the probe module 14 and check the stability of the fit of the probe module 14 to the body (step 382). These steps may be repeated iteratively until the observed stability is determined to be satisfactory.

[0071] Once the probe is positioned, the clinician may optimize the imaging device settings (step 386). As an example, the clinician may optimize the imaging device settings for best image quality in embodiments where imaging is performed in support of or as part of treatment management. The image settings described below may be saved for future use by the patient. Examples of ultrasound image settings include, but are not limited to, depth, gain, frequency, and other common parameters to maximize image quality.

[0072] Once the position and imaging device settings are established as described above, one or more test runs can be performed on the patient (step 390). By way of example, the patient may be instructed on how to wear the wearable structure 100 and observed performing several runs (e.g., 1, 2, 3, 4, 5, etc.) to test the repeatability of the wearable structure. As part of the patient trial process, the clinician may repeat one or more of the earlier steps to provide a reliable and repeatable fit of the wearable structure 100. Once the wearable structure 100 and probe module 14 are fitted and configured, system settings for the probe module 14 are performed. The embedded imager and computing electronics are determined and saved for future use. By way of example, settings for physical adjustments 398 of the wearable structure 100 can be recorded and saved (step 394). Additionally, the clinician or the system can record and save imager settings 402 and / or sensor readings 406 related to fit. The state of the structure 100 (e.g., contact force or tension, posture, etc.) can also be recorded and saved. Such images and / or sensor fit settings (e.g., sensor output) can be used in subsequent sessions to check and guide the fit of the wearable structure 100 in non-clinical treatment situations. Similarly, the location (depth and axial position) of the target within the optimal scan plane can be determined and saved for subsequent use. The saved settings can be used to guide a user at home (or another non-clinical environment) to confirm proper fit of the wearable structure 100 when used in a non-clinical environment.

[0073] While the above relates to example steps for attaching a probe positioning structure, it should be understood that additional steps may be performed as part of a fitting session. For example, as part of such a session, patient-specific baseline image data may be acquired for automated processing. Similarly, a mock administration sequence may be performed to test performance.

[0074] It should also be noted that the design and / or selection of the probe module 14 and / or probe holder 200 may be an aspect of the fitting or design process. In particular, the probe module 14, probe holder 200, and particular probe-holder combinations may have varying ranges of motion when fitted and attached to the wearable structure 100. In the fitting process, certain types of movement may be limited by or dependent on other aspects of the probe's orientation. For example, the maximum "locked" orientation of the probe may depend on the tilt angle and / or spin angle of the probe. This dependency is a function of the design of the probe module 14 and probe holder 200 (e.g., the holder's ball capture mechanism relative to the wearable structure 100).

[0075] With this in mind, the probe module 14, probe holder 200, and particular probe and holder combinations may be designed to have specific or known characteristics regarding their motion dependencies and interrelationships, and in this way, an appropriate probe module 14 and probe holder 200 can be selected in a fitting process.

[0076] For characterization, certain techniques can be used and are described here for completeness. In one such characterization technique, different combinations of probe modules 14 and probe holders 200 are optically tracked for their relative orientation (for each captured frame) with respect to the wearable structure 100 while moving through their full range of motion for different permutations of orientation. In one example, the relative orientation of the probe and the wearable structure (e.g., belt) is calculated using inverse kinematics and a known model of the components in question.

[0077] To determine the extent of the working envelope, a convex hull (i.e., a convex three-dimensional (3D) structure) of a Delaunay triangulation can be created based on the orientation working envelope values displayed in 3-space: x-values = rock, y-values = tilt, and z-values = spin, which are the three angles that represent the spherical joint. In practice, the convex hull may be an envelope generated using a 3-space point cloud derived from observed tracking data converted to relative angular joint data while moving the tracked probe module 14 (mounted in the tracked probe holder 200) relative to the wearable structure. This triangulated surface for a given probe module 14 and probe holder 200 represents the extent of the working envelope as a convex surface. In this way, for a given value in one direction (e.g., a given "tilt"), the range of motion available at other angles (e.g., "rock" and "spin") for a given probe module 14 and probe holder 200 may be determined. A similar approach can be used to determine the range of motion and configuration-dependent limits for particular probes and probe holders with aspherical joints (i.e., prismatic and / or revolute). Alternatively, the relative motion of a CAD model can be simulated during the design process to generate a convex hull.

[0078] In practice, the outer boundary of the convex hull is primarily important because it represents the range of motion: in this context, the convex hull boundary represents the configuration-dependent relationship of the lock, tilt, and spin angle parameters for a particular probe and probe-holder combination, thereby defining the envelope of the range of motion that depends on the configuration of the three orientation angles.

[0079] To simplify the interpretation of the 3D structure corresponding to the convex hull, we can generate two-dimensional "slices" through the 3D structure along an axis to better see the range of motion for two given orientation angles. This conceptually corresponds to fixing one angle and moving the other two angles, finding the angles relative to the fixed first angle (e.g., how much the rock and tilt angles can be varied relative to a fixed spin angle).

[0080] 16 is illustrated as a series of isometric contours 410, each corresponding to a different position in the z-dimension (here, the spin dimension) and representing a different range of probe / probe holder motion for a given patient (or wearable structure 100, in certain cases). The edges of each isometric contour 410 in this example indicate the range of tilt (vertical axis) and rock (horizontal axis) motion for different probe / probe holder combinations at different values (different subplots) of constant spin. Using such techniques, different probe modules 14, probe holders 200, and / or probe and holder combinations can be evaluated for compatibility in the fitting procedures discussed herein. In the example shown in FIG. 16, two different probe and holder combinations 410a (H2run1, H2run2, and H2run3) and 410b (H2wTilt) are evaluated for suitability for seven different patients (collectively, patients 412 (G7, TO, H8, Q4, X7, D2, W2)). While both probe and holder 410a and 410b can accommodate all seven patients, probe and holder 410b may be less desirable because it leaves little margin for swing and tilt adjustment of the spin angle configured for patient X7. Here, probe and holder 410a provides a better fit for all seven different patients. Similarly, probe modules 14 and / or probe holders 200 can be designed to provide a desired range of motion using these techniques for evaluating range of motion, or alternatively, existing designs can be compared in terms of their range of motion.

[0081] The foregoing description relates to examples in which the wearable structure 100, or an aspect of the wearable structure 100, is a configurable garment or article that can be adjusted via various fitting structures or techniques (e.g., pull straps used to tighten webbing, adjustable or trimmable straps, inflatable bladders, etc.). In other embodiments, the wearable structure 100 (or components used in conjunction with a probe positioning structure, such as a customized transducer placement fixture or plate) may instead be manufactured or constructed based on an individual patient's body. That is, instead of being an adjustable, "one size fits all" device or garment or having a bin of distinct sizes of customizable devices or garments, an individual wearable structure 100 or component used in conjunction with a probe positioning structure may be constructed based on the patient's body to be unique to that patient. Thus, in such implementations, a fitting process or session may instead be performed to parameterize and construct a custom-fitted wearable structure 100 or patient-specific component, such as a custom-fitted probe interface device, as opposed to adjusting a more generic wearable structure 100 or component that fits the patient.

[0082] By way of example, and referring to FIG. 17 , in one embodiment, a patient can be digitally scanned for surface profile measurement 422 (step 420) using an infrared depth sensor, laser scanning technology, or other anthropometric means. The surface profile scan can be performed in a clinical setting (e.g., a clinician's office) or in a non-clinical setting (e.g., at the patient's home using a portable system and a mobile operator, or by the patient themselves, e.g., a cell phone application using profile scanning technology). Such a scan, in one embodiment, may offer certain advantages, such as taking less than a minute (e.g., 30 seconds), being performed without patient contact, and being performed while the patient is fully clothed (e.g., in tight-fitting clothing), thus ensuring patient privacy.

[0083] However acquired, the digital surface profile scan data (e.g., surface profilometry 422) can be used to fabricate a custom-fit fixture 426 (e.g., an ultrasound probe interface device) used to hold and position the probe module 14 on a patient during a treatment session. The custom-fitted fixture 426 can include, but is not limited to, a transducer mounting plate secured to or integrated into a custom fabricated component that fits the patient's anatomy. With respect to fabricating such a custom-fitted fixture 426 based on the surface profile scan data 422, such a fixture may be additively manufactured (e.g., 3D printed) or otherwise fabricated using a suitable custom manufacturing technique (step 424). For example, with respect to a transducer mounting plate incorporated into the custom-fitted fixture 426, a 3D printing approach may be appropriate since only one custom plate is required. In such an implementation, the patient-facing side of the fixture may have a geometry determined by the surface profilometry 422, while the opposite face or surface (i.e., the exposed side) may have a common transducer mounting flange to which the probe modules 14 are attached. This approach may allow the transducer assembly to be mounted in a custom-fit fixture 426 that conforms to the patient's anatomy.

[0084] In another embodiment, as shown in FIG. 18 , a thermoformable (e.g., thermomoldable) custom-fit plate can be formed, such as by using a thermoformable substrate, according to the described process flow. In one such example, the patient removes all intervening clothing and assumes the position to be adopted during the treatment session. A thermoformable sheet (e.g., thermoformable substrate 480), such as a thermoformable foam or polymer sheet, is heated (step 484) to form a moldable substrate 488, which is then placed over the treatment target area (step 492) and pressure is applied. Pressure is applied to ensure the thermoformable sheet conforms to the underlying anatomy. In such an embodiment, patient contact time may be 5 minutes or less. In one embodiment, the substrate (e.g., sheet) has an opening (e.g., a central window) exposing the treatment target area and is surrounded by a pressure-sensitive adhesive. A therapy transducer mounting assembly (e.g., probe mounting plate 496) is adhered (step 500) to this perimeter of the adhesive to form a mounting assembly 504. While the substrate is still conformable, a probe module 14 with a therapy transducer is introduced (step 508) into the mounting assembly 504 and manipulated to acquire an anatomical target (step 512). With the patient in the treatment position, the substrate is cooled (step 516) and hardens, forming a rigid mount for the transducer assembly in the form of a custom-fit plate 520 that conforms to the patient's body. A belt, garment, or other mechanism can then be used to secure the custom-fit plate 520 to the patient for the treatment session.

[0085] Referring to FIG. 19 , in a further embodiment, a material having an uncured (flowable or moldable) state and a cured (solid) state can be used to form an impression of the patient's body at the site where the transducer 20 contacts the patient. By way of example, in one embodiment, a quick-curing two-part silicone can be used as the liquid casting material in conjunction with a perimeter wall (e.g., an adhesive foam sealing ring 464) to limit the casting area. Alternatively, in another embodiment, the casting material can be plaster of Paris, expanding foam (e.g., a quick-curing foam in a bag), or a similar material that is moldable when uncured. As shown in FIG. 19 , this can be represented as a generalized step in the illustrated process flow. In this example, the sealing ring 464 (i.e., the perimeter wall) is applied to the target treatment area while the patient is in the treatment position to define the area where the casting will be formed (step 542). The sealing ring 464 can be an adhesive foam structure that temporarily adheres to the area to be treated. An example of such a seal ring 464 is shown in FIG.

[0086] Uncured casting material 550 (e.g., uncured silicone, uncured plaster) is injected into the area defined by the sealing ring 464 (step 552) and may conform to the patient's anatomy in this defined area to form a molded body impression 460 upon hardening. The sealing ring 464 blocks the flow of uncured casting material 550, allowing a sufficient height (e.g., thickness) of casting material to accumulate to form the desired molded body impression 460. An example is shown in FIG. 21. In some situations, pressure may be applied to the casting material to conform it to the patient, such as in embodiments where the casting material is an expanding foam in a bag and the bag is pressed against the patient's anatomy. In certain embodiments, the casting material may harden in 7-10 minutes (e.g., for silicone or plaster) or within 5 minutes (e.g., for expanding foam).

[0087] A transducer mounting plate 454 (e.g., a rigid transducer integration plate) may be placed on or within the uncured casting material 550 (step 560). In one embodiment, the transducer mounting plate 454 may have multiple anchors or bosses for mechanical fixation. After the casting material has cured (i.e., hardened), the mounting plate 454 is secured to the casting material. An example of such a transducer mounting plate 454A having anchors 580 is shown in FIG. 22A. Alternatively, as shown in FIG. 22B, the transducer mounting plate 454B may include multiple holes 582 throughout to allow the casting material (e.g., silicone) to flow through the transducer mounting plate 454B, embedding the plate within the casting material when submerged and installed.

[0088] As discussed above, with the transducer in place, an appropriate environmental trigger (temperature, time, chemical reaction, exposure to a specific wavelength of radiation (e.g., ultraviolet light)) is used to solidify the casting material into the transducer mounting plate 454, providing a surface that conforms to the patient opposite the area provided for attachment of the probe module 14. In this manner, a custom-fit plate 520 can be produced. The transducer mounting plate 454 can be used with a belt or other attachment mechanism to secure the probe module 14 to the patient using a fixture customized for that patient. The transducer mounting plate 454, probe module 14, mold impression 460, and seal ring 464 are shown in an exploded view in FIG. 23.

[0089] As an example, for each example described herein relating to the manufacture and use of a custom-fit plate 520 for positioning a probe module 14 on a patient, various belts, vests, or other garments described herein can be used to position and hold the custom-fit plate 520 on the patient with the probe module 14 attached. As an example, various belt assemblies can be used to hold and position the custom-fit plate 520 (and attached probe module 14) for daily or periodic treatments. As discussed herein, the belt can be adjustable and can consist of a simple strap around the torso, multiple straps that can engage shoulders or other anatomical anchor points, or a full vest that contacts the patient's entire chest, sides, and back. As described herein, the fit and adjustment of such a belt (or other positioning device) can be achieved using the systems or techniques described herein. For example, tensioning of the device can be achieved using elastic materials, a ratchet and locking cable tensioning system, pump inflation, or lacing. After tensioning the elastic materials, hook-and-loop fasteners can be used to lock the belt in place. Additionally, the belt, vest, or other garment-type device may incorporate rigid structures (e.g., straight or curved plates, rods, etc.) that serve to serve as attachment points for the probe module 14 or the custom-fit plate 520 and / or to conform to and "anchor" particular anatomical features (ribs, spine, sides of the torso, etc.). In such embodiments, such features may help prevent the belt, vest, or other garment from moving relative to the body once secured in place.

[0090] The above generally relates to techniques for fabricating customized, patient-specific interfaces for probe modules that contact target regions of a patient's anatomy (e.g., custom-fit plate 520). However, it should be understood that custom-fit structures are also possible, more substantial or comprehensive, such as larger structures customized to fit and accommodate larger anatomical regions, such as those attached to the torso, arms, legs, etc. Such approaches can employ techniques similar to those described herein to fabricate customized structures, such as casting techniques using moldable or thermally flexible plastics or polymers (e.g., thermoformable foam sheets or polymers), hardenable materials that harden after expansion (e.g., silicone, plaster, expanded foam, etc.).

[0091] In addition to the above-described approaches to techniques for reproducibly and reliably holding the probe module 14 at a target area on a patient, further aspects of the present technology allow for complete or partial target immobilization to facilitate non-clinical therapeutic applications. As one example, target drift during neuromodulation therapy can occur due to breathing or patient movement. Such drift can make it difficult to maintain alignment of the transducer with the anatomical target.

[0092] To avoid such target drift, in some embodiments, external pressure or constraints may be utilized to reduce or eliminate the degree of patient movement relative to the target treatment area and the contact point of the probe module 14. In this regard, probe modules with reduced electronic steering capabilities may be used, as electronic steering may not be required to compensate for target drift.

[0093] As an example, external pressure can be applied by pushing the transducer inward toward the target, and a rigid clamp mechanism can be used to apply the force necessary to locally displace tissue between the transducer and the target anatomy. As this tissue is displaced, the distance from the transducer to the target anatomy also decreases, allowing a transducer with a shorter focal depth to reach a deeper target region. A belt or other probe positioning structure, as described herein, can also be used to apply more general compression to the region, thereby reducing target motion.

[0094] This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to practice the invention, including making and using any devices or systems, and performing any methods incorporated therein. The patentable scope of the invention is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be 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 contain equivalent structural elements that do not differ insubstantial way from the literal language of the claims. [Explanation of symbols]

[0095] 10: Neuromodulation System 12: Therapy Module 14: Energy Applicator / Probe Module 16: Imaging Module 20: Transducer 22: Imaging Transducer 24: Therapy Transducer 30: HW Controller 32: MCU 34: FPGA 40: Sensor 50: Optional Actuator 80: Master Controller 84: Memory 86: HW Controller 88: MCU 90: FPGA 92: Therapy Pulser Receiver 94: Safety Circuit 96: Power Management 100: Wearable Structure 106: Belt 112: Fitting Function 114: Clip 116: Strap 140: Coupling Feature 150: IMU 152: Contact Force Sensor 156: Tension Sensor 180: Acoustic Window 200: Probe Holder 204: Probe Cap 206: Beam Cone 208: Probe Carriage Frame 210: Z-Axis Rail 212: Z-axis carriage 220: Spherical joint 222: Spherical joint clamp 226: Clamp lever 240: Drawstring 242: Pull handle 244: Drawstring or webbing section 246: Power on / off button 250: Frame 252: Cable fastener 254: Attachment point 256: Magnetic closure 260: Probe module cable 270: Excess length 272: Clip 280: Hook-and-loop system 290: Cell phone 292: Internal structural part 300: Vest 304: Skin 306: Zipper 310: Pocket 410: Conformal contour 412: Patient 454, 454A, 454B: Transducer mounting plate 460: Molded body impression 464: Sealing ring 520: Custom fit plate 580: Anchor 582: Hole

Claims

1. A wearable device, an ultrasound probe; a wearable positioning structure configured to hold the ultrasound probe; and a probe cap attached to the ultrasonic probe via a probe coupling structure (200); Including, the ultrasonic probe comprises one or more ultrasonic transducers; the one or more ultrasound transducers are configured to emit a treatment beam; the one or more ultrasound transducers are configured to emit an imaging beam; the treatment beam of the ultrasound probe passes through the probe cap when emitted; the probe cap determines an angular orientation of the ultrasound probe relative to the wearable positioning structure; The probe cap is interchangeable with another probe cap; the other probe cap corresponds to a different angular orientation relative to the wearable positioning structure when coupled to the ultrasound probe; A wearable device, wherein the probe cap is configured to be coupled to the wearable positioning structure while being fixed to the ultrasound probe, and positions the ultrasound probe in an acoustic window formed in the wearable positioning structure at the determined angular orientation.

2. The wearable device of claim 1 , wherein the one or more ultrasound transducers include one or more ultrasound transducers that emit the imaging beam and the treatment beam.

3. The wearable device of claim 1 , wherein the treatment beam is in the frequency range of 0.2 MHz to 2 MHz.

4. The wearable device of claim 1 , wherein the wearable positioning structure comprises one or more adjustable fitting mechanisms that position the acoustic window on a patient.

5. The wearable device of claim 4 , wherein the one or more adjustable fitting mechanisms include one or more of a strap, a clip, a ratchet, a pull cord, a lacing tensioner, or an inflatable structure.

6. The wearable device of claim 5 , wherein the probe cap is fixed in orientation relative to a frame of the probe coupling structure.

7. A wearable device, an ultrasound probe; a wearable positioning structure configured to hold the ultrasound probe; and Including, the ultrasonic probe comprises one or more ultrasonic transducers; the one or more ultrasound transducers are configured to emit a treatment beam; the one or more ultrasound transducers are configured to emit an imaging beam; The wearable positioning structure includes: one or more adjustable fitting mechanisms for positioning an acoustic window formed in the wearable positioning structure on a patient; and one or more sensors configured to measure and guide adjustment of an initial attachment of the wearable positioning structure and / or adjustment of subsequent attachments of the wearable positioning structure prior to use.

8. 8. The wearable device of claim 7, wherein the one or more sensors include one or more of an inertial measurement unit (IMU), a contact force sensor, or a tension or strain sensor.

9. 10. The wearable device of claim 1, wherein sensor data generated by one or more sensors that record the operation of components directly or indirectly associated with the ultrasound probe is used to adjust the position and orientation of the ultrasound probe.

10. A wearable device, an ultrasound probe; a wearable positioning structure configured to hold the ultrasound probe; and Including, the ultrasonic probe comprises one or more ultrasonic transducers; the one or more ultrasound transducers are configured to emit a treatment beam; the one or more ultrasound transducers are configured to emit an imaging beam; the wearable positioning structure includes one or more adjustable fitting mechanisms that position an acoustic window formed in the wearable positioning structure on a patient; A wearable device wherein sensor data generated by one or more sensors that measure and guide fitting adjustments of the one or more adjustable fitting mechanisms is provided as input to one or more automated routines that automatically adjust the one or more adjustable fitting mechanisms to adjust the position and orientation of an ultrasound probe during operation.

11. The wearable device of claim 5 , wherein the probe cap is configured to be attached to the probe coupling structure and to fix an orientation of the probe cap relative to the probe coupling structure.

12. the probe-binding structure comprises a frame; the frame holds a probe cap; the frame is configured to move relative to the wearable positioning structure when the lock of the probe coupling structure is in an unlocked position; The wearable device of claim 5 , wherein the frame is in a fixed position relative to the wearable positioning structure when the lock of the probe coupling structure is in a locked position.

13. The wearable device of claim 1 , wherein the wearable positioning structure comprises a probe holder comprising a movable frame configured to allow movement of the ultrasound probe in one or more degrees of freedom.

14. 10. The wearable device of claim 1, wherein the wearable positioning structure comprises a probe holder comprising a spherical joint configured to enable movement of the ultrasound probe in one or more of a locked, tilted, or spin angular orientation.

15. The wearable device of claim 1 , wherein the wearable positioning structure is configured to fit the patient.

16. 1. A method of operating a wearable device applied to a subject, comprising: The wearable device is an ultrasound probe; a wearable positioning structure configured to hold the ultrasound probe; and Including, the ultrasonic probe comprises one or more ultrasonic transducers; the one or more ultrasound transducers are configured to emit a treatment beam; the one or more ultrasound transducers are configured to emit an imaging beam; the wearable positioning structure includes one or more adjustable fitting mechanisms that position an acoustic window formed in the wearable positioning structure on a patient; 1. A method comprising: automatically adjusting the one or more adjustable fitting mechanisms with sensor data generated by one or more sensors that measure and guide adjustment of the attachment of the one or more adjustable fitting mechanisms, the sensor data being provided as input to one or more automated routines that adjust the position and orientation of an ultrasound probe.

17. 17. The method of claim 16, wherein the step of saving the one or more parameters comprises locking the ultrasound probe in place using a locking mechanism to prevent adjustment of either or both of the position or orientation of the ultrasound probe.

18. 18. The method of claim 17, wherein the locking mechanism is provided as part of a probe holder that allows movement and orientation of the ultrasonic probe in x, y, and z dimensions, and the locking mechanism locks the ultrasonic probe in position in the x, y, and z dimensions and locks the orientation of the ultrasonic probe.

19. The method of claim 16 , wherein during the adjusting step, guidance is received based on one or both of image data based on the imaging beam or the sensor data.

20. The method of claim 16 , wherein the wearable device includes a probe cap attached to the ultrasound probe via a probe coupling structure.

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