WO2026005912A1 - Low-profile ultrasound transducer with dose monitoring and adaptive regulation - Google Patents

Abstract

Systems and methods herein provide for delivering sustained acoustic medicine (SAM) to a body part of a user with a wearable diathermy device. In one embodiment, the device includes a transducer comprising a piezoelectric device operable to deliver ultrasound radiation to the body part of the user. The device also includes one or more temperature sensors operable to sense temperature changes in the transducer. The device also includes a controller communicatively coupled to the transducer and the one or more temperature sensors. The controller is operable to drive the piezoelectric device, to monitor the temperature changes via the one or more temperature sensors, and to adjust a drive signal to the piezoelectric device when a sensed temperature from the one or more temperature sensors reaches a threshold temperature.

Description

LOW-PROFILE ULTRASOUND TRANSDUCER WITH DOSE MONITORING

AND ADAPTIVE REGULATION

Cross Reference to Related Applications

[0001] This patent application claims priority to, and thus the benefit of an earlier filing date from, U.S. Provisional Patent Application No. 63/665,996 (filed June 28, 2024), the contents of which are hereby incorporated by reference.

Background

[0002] Conventional low-profile ultrasound transducers and wearable ultrasound systems struggle to deliver sustained and effective diathermy across various anatomical locations, such as the hamstring, knee, shoulder, wrist, and elbow, for extended periods. This limitation arises due to the differing anatomical characteristics of these areas, including variations in muscle, ligament, tendon, bone, and cartilage composition, all of which influence local heating and ultrasound dosing. The challenge is further compounded by individual patient differences in size and body mass index (BMI), as smaller or larger joints require tailored dosing levels to achieve optimal diathermy.

[0003] Additionally, traditional therapeutic ultrasound systems are typically at least the size of a shoebox and consist of components such as a user interface, power generation circuitry, and a separate transducer connected via a handheld wand. These devices, which generally weigh between 6 and 20 pounds, require a wall power source and deliver ultrasound energy ranging from 0 to 4 Watts at frequencies of 1 to 3 MHz The transducers in these systems are designed to penetrate tissue and deliver therapeutic ultrasound, but treatments are typically short in duration (e.g., 5 to 20 minutes).

[0004] While traditional ultrasound therapies are effective for brief sessions, prolonged treatment can enhance biophysical effects, such as tissue bioregeneration for faster healing and improved pain management. Unfortunately, current devices are not designed to support sustained therapy because, among other reasons, traditional ultrasound therapy devices have no control over the ultrasound radiation being delivered other than “on” or “off”. That is, traditional ultrasound therapy devices do not monitor any type of Sustained Acoustic Medicine (SAM) being delivered. These devices simply rely on an arbitrary treatment time.

[0005] Some technologies claim to offer portable therapeutic ultrasound solutions, but these often generate only surface-level ultrasound waves and fail to provide deep tissue treatment. Moreover, conventional therapeutic ultrasound devices are generally unsuitable for extended use due to safety concerns, their non-portable size, and/or their reliance on external power sources. As a result, there is a clear need for innovative, portable therapeutic ultrasound devices capable of safely delivering deep-tissue ultrasound energy for prolonged periods.

Summary

[0006] Systems and methods herein provide for delivering SAM to a user (e.g., a patient) via a wearable diathermy device. In one embodiment, the wearable diathermy device comprises a transducer comprising a piezoelectric device operable to deliver ultrasound radiation to the body part of the user. The wearable diathermy device also includes one or more temperature sensors operable to sense temperature changes in the transducer, and a controller communicatively coupled to the transducer and the one or more temperature sensors (optical and/or traditional). The controller is operable to drive the piezoelectric device, to monitor the temperature changes via the one or more temperature sensors, and to adjust a drive signal to the piezoelectric device when a sensed temperature from the one or more temperature sensors reaches a threshold temperature. For example, the controller may be operable to increase an energy output of the piezoelectric device (e.g., by adjusting frequency of the piezoelectric device) when the sensed temperature is below the threshold temperature and/or decrease an energy output of the piezoelectric device (e.g., by adjusting frequency of the piezoelectric device) when the sensed temperature is above the threshold temperature.

[0007] In one embodiment, the controller is further operable to maintain a desired temperature within a range of about +/- 1° C via adaptive control of the piezoelectric device. The controller may be further operable to determine an amount of energy delivered to the body part of the user during a treatment. The controller may direct a display configured with the wearable diathermy device or personal device of the user to display the amount of energy delivered to the body part of the user during the treatment. The controller may be further operable to determine an average temperature of the transducer from the one or more temperature sensors.

[0008] In some embodiments, the wearable diathermy device includes one or more light emitting diodes (LEDs) operable to provide an illuminated indication of a SAM treatment to the user and/or one or more tactile components operable to provide a vibratory indication of a SAM treatment to the user. The wearable diathermy device may also include a communication module operable to convey diathermy dosage information of the user to a medical provider.

[0009] In another embodiment, a method of delivering SAM to a body part of a user includes, with a wearable diathermy device, driving a transducer comprising a piezoelectric device to deliver ultrasound radiation to a body part of a user, sensing temperature changes in the transducer with one or more temperature sensors configured with the wearable diathermy device, adjusting a drive signal to the piezoelectric device when a sensed temperature from the one or more of the temperature sensors reaches a threshold temperature.

[0010] In another embodiment, a non-transitory computer readable medium comprises instructions that, when executed by a controller of a wearable diathermy device, direct the controller to deliver SAM to a body part of a user. The instructions direct the controller to drive a transducer comprising a piezoelectric device to deliver ultrasound radiation to a body part of a user, sense temperature changes in the transducer with one or more temperature sensors configured with the wearable diathermy device, and adjust a drive signal to the piezoelectric device when a sensed temperature from the one or more of the temperature sensors reaches a threshold temperature.

[0011] The various embodiments disclosed herein may be implemented in a variety of ways as a matter of design choice. For example, some embodiments herein are implemented in hardware whereas other embodiments may include processes that are operable to operate the hardware. Other exemplary embodiments, including software and firmware, are described below. Brief Description of the Drawings

[0012] Some embodiments arc now described, by way of example only, and with reference to the accompanying drawings. The same reference number represents the same element or the same type of element on all drawings.

[0013] FIG. 1 is a block diagram of a system for delivering sustained acoustic medicine (SAM) to a body part of a user with a wearable diathermy device, in one exemplary embodiment.

[0014] FIG. 2 is a block diagram of a wearable diathermy device, in one exemplary embodiment.

[0015] FIG. 3 is a flowchart of a process for delivering SAM to a body part of a user, in one exemplary embodiment.

[0016] FIG. 4 is a graph illustrating the temperature control of the wearable diathermy device, in one exemplary embodiment.

[0017] FIGS. 5A-5D are graphs 500 that illustrate the temperature control at an applicator by the modulation of the piezoelectric device in the transducer.

[0018] FIG. 6 is a graph that illustrates various depths of diathermy penetration into a user’s body when the wearable diathermy device is performing a treatment on the user, in one exemplary embodiment.

[0019] FIG. 7 is a flowchart of a process for initiating the wearable diathermy device, in one exemplary embodiment.

[0020] FIG. 8 is a flowchart of a process for calibrating the wearable diathermy device, in one exemplary embodiment.

[0021] FIG. 9 is a flowchart of a process that illustrates the main loop of operation of the wearable diathermy device, in one exemplary embodiment.

[0022] FIG. 10 is a flowchart of a process is a continuation of the process of FIG. 9, in one exemplary embodiment. [0023] FIG. 11 is a flowchart of a process that illustrates the temperature control during operation wearable diathermy device, in one exemplary embodiment.

[0024] FIG. 12 is a flowchart of a process for determining whether the wearable diathermy device is operating in the desired zone to provide a SAM dose, in one exemplary embodiment.

[0025] FIG. 13 is a flowchart of a process illustrating when the wearable diathermy device is operating in the SAM zone, in one exemplary embodiment.

[0026] FIG. 14 is a flowchart of a process that continues the process of FIG. 13, in one exemplary embodiment.

[0027] FIG. 15 depicts one illustrative cloud computing system operable to perform the above operations by executing programmed instructions tangibly embodied on one or more computer readable storage mediums.

[0028] FIG. 16 is a block diagram of a system operable to monitor a SAM device delivering a SAM dosage, in one exemplary embodiment.

Detailed Description of the Drawings

[0029] The figures and the following descriptions illustrate specific exemplary embodiments. It will thus be appreciated that those skilled in the art will be able to devise various arrangements that, although not explicitly described or shown herein, embody certain principles and are included within the scope of the embodiments. Furthermore, any examples described herein are intended to aid in understanding the embodiments and are to be construed as being without limitation to such specifically recited examples and conditions. As a result, the embodiments are not limited to any of the examples described below.

[0030] FIG. 1 is a diagram of a system for delivering sustained acoustic medicine (SAM) to a body part of a user, in one exemplary embodiment. The embodiments herein may be utilized for tissue bioregeneration, accelerated healing, pain management, etc. The present embodiments include a relatively a long duration wearable ultrasound delivery device that provides specific and accurate ultrasound energy dosing, accurate regulation of maximum diathermic tissue levels in real time, and direct user feedback over the course of treatment.

[0031] For example, maximum diathermy generally depends on both the duration and temperature of the treatment. The human body tolerates higher temperatures for shorter periods and lower temperatures for longer durations without incurring thermal tissue damage. As a result, it is important to monitor the relationship between time and temperature and adjust diathermy levels accordingly to ensure safety. This adjustment is especially important during treatments ranging from 10 minutes to several hours, such as sessions lasting 4 hours or more. In addition to being cumbersome, conventional wearable ultrasound systems simply monitor the treatment time, and thus provide no means for ensuring the delivery of a recommended diathermy dose. The embodiments herein overcome the failings of the prior art by providing an adaptive wearable diathermy device that is operable to maintain a specific diathermy temperature to deliver a maximum diathermy dosage while also preventing thermal tissue damage.

[0032] The present embodiments can adjust temperature/diathermy levels in real time to provide maximum diathermic levels over the course of multiple hours. Thus, the present embodiments may be operable to adaptively deliver a requisite ultrasound dose in a safe and effective fashion to a user. For example, the wearable diathermy device can deliver maximum diathermy of 55° C for the first 15 minutes of treatment, 50° C from 15 to 60 minutes of treatment, 47° C from 60-120 minutes of treatment, and 45C until the end of treatment. Of course, those skilled in the art will readily recognize that treatment times and temperatures may vary from patient to patient and that the embodiments herein are configured to adaptively accommodate different patients.

[0033] In one embodiment, the wearable diathermy device comprises a low-profile ultrasound transducer that presents a user with on-off status, warnings, and optimal SAM diathermy via LED notifications on the top of the housing along with vibratory tactile notifications. The LED notifications may provide feedback to achieve mild, moderate, and vigorous local diathermy at a tissue location via direct feedback from the temperature control unit within the device. [0034] The transducer may be calibrated specifically to the patient at each treatment site so that maximum diathermy is sustained without over temp status and tissue injury. Maximum diathermy and ultrasound dosimetry can also be calibrated at the treatment site anonymously to achieve desired ultrasound exposure parameters such as pulses, continuous wave or the combination of both for the desired long-duration treatment.

[0035] Embodiments include a wearable, long-duration, ultrasonic diathermy device for use in applying deep therapeutic treatment. The device can be worn daily, including for time periods exceeding thirty minutes to up to forty-eight hours. In one embodiment, the device can be utilized for the aforementioned time period on a single power source charge.

[0036] Certain embodiments include: 1) a power controller (e.g., with DC output); 2) an applicator (e.g., with integrated RF drive electronics); 3) an ultrasound transducer; 4) closed-loop treatment monitoring apparatus (e.g., continuous monitoring capabilities), including a thermal cutoff; and 5) an ultrasound coupling bandage. In some embodiments, the bandage is adapted for one time use.

[0037] Embodiments can be utilized for ultrasound-related applications, including but not limited to, hands-free deep tissue heating and/or soft tissue bioregeneration for accelerated healing. Additionally, embodiments of the present device also take and provide a wearer with biometric measurements, including, but not limited to, blood flow, blood oxygen, mechanical elastography, acoustic spectroscopy, and skin temperature, etc. In embodiments, these biometric measurements may be taken by the applicator, the coupling bandage, the controller, and/or an external device. The measurements can be utilized to alter/control the treatment regimen provided by the device. In one embodiment, the device may self-modulate over the course of a weekly/monthly treatment to improve therapeutic outcome, including but not limited to controlling the dose administered based on biometric feedback.

[0038] FIG. 1 is a block diagram of a system for delivering sustained acoustic medicine (SAM) to a body part of a user with a wearable diathermy device, in one exemplary embodiment. In this embodiment, the device 100 includes least one applicator 110, an integrated power cutoff temperature sensor, also termed a thermal cutoff 120, an acoustic coupling detector, and a coupling bandage 130. In one embodiment, the coupling bandage 130 includes an interlocking lip, which is built into an applicator housing 160. The interlocking lip couples the applicator 110 with the coupling bandage 130. The applicator 110, interlocking lip, thermal cutoff 120, acoustic coupling detector, and coupling bandage 130 may work together with a power controller 170 during the administration of ultrasonic diathermy from the device 100.

[0039] Generally, in one embodiment, a power controller with DC output, includes a power source, such as a battery. The power controller 170 provides user control of the device and delivers electrical power to the applicator(s) 110 with controlled, stable amplitude, for a defined period of time. In the applicator 110, with integrated RF drive electronics, drives at least one transducer, in order to transmit ultrasound waves through a lens. This applicator is positioned to deliver ultrasound to a site of the body of the wearer and a coupling bandage 130 is utilized both to lubricate the surface where the ultrasound will be administered, and to affix the applicator 110 to the treatment site on the body of the wearer. The applicator 110 is connected to the coupling bandage at the applicator 110 housing’s interlocking/coupling lip 140. When coupled to the coupling bandage 130, the lens of the applicator 110 contacts a reservoir in the coupling bandage 130 that contains a hydrogel. Thus, the applicator 110 administers ultrasound through this hydrogel reservoir in the bandage 130. This coupling may prevent the surface of the radiating ultrasound face of the applicator 110 from coming into contact with the skin of the wearer (e.g., patient) receiving an ultrasound treatment.

[0040] In one embodiment, the coupling bandage 130 has a built-in reservoir filled with a biocompatible hydrogel. The hydrogel may be comprised of traditional ultrasound gel, water and polyethylene oxide, which is commonly used in wound healing devices, or other hydrogels, as understood by one of skill in the art. The reservoir of hydrogel may reduce the need for the use of traditional ultrasound coupling gel in order to utilize the ultrasound, however, embodiments of the device can utilize this more traditional approach. In one aspect, the coupling bandage 130 assists in securing the applicator 110, so that the device can operate in a hands-free mode for up to a multi-hour duration. In one embodiment, ultrasound treatments, including but not limited to deep tissue heating (deep tissue diathermy), may be administered by an applicator 110 for thirty minutes or more with no user intervention, and/or in an active or mobile environment. [0041] The thermal cutoff 120 and the acoustic coupling detector are components of the applicator 110 and arc configured to dc-activatc the applicator 110 to stop the ultrasound transmission if the device 100 functions in a manner that poses a danger to the wearer. In one embodiment, the thermal cutoff 120 can be pre-set, for example, during manufacture, to switch the applicator 110 off if the surface contacting the treatment site exceeds a threshold level of heat. In one embodiment, a thermal cutoff 120 monitors the patient-contacting surface of the applicator.

[0042] Responsive to additional conditions, which will be discussed later, the systems on the applicator 110 can modulate the ultrasound output. Modulating includes, but is not limited to, automatically turning off the applicator utilizing the thermal cutoff, adjusting the frequency of the output, and/or pulsing the ultrasound.

[0043] The thermal cutoff 120 is a safety measure, and therefore, the pre-configured temperature point for cut-off should be achieved when the device is operated in extreme environments or without appropriate coupling. A temperature controller 150 within an embodiment of the device provides an additional level of safety when the device is operational by providing closed-loop continuous ultrasound heating of the body without overheating the tissue to unsafe levels. The thermal cutoff 120 also protects the applicator 110 from overheating and damaging any piezoelectric elements, including but not limited to a crystal element, within the ultrasound applicator 110. A further advantage of the thermal cutoff 120 is that it increases the durability of the device.

[0044] In one embodiment, the closed-loop monitoring system, which also includes an acoustic coupling detector, may also monitor the ultrasound leaving the device (through the applicator 110), the treatment time, and the blood oxygenation, and can adjust the ultrasound treatments based on this monitoring. Additional sensors may be integrated into the applicator 110 in order to enable monitoring of the ultrasound treatment and the wearer/patient. In one embodiment, a near infrared sensor is integrated in the applicator 110. In one embodiment, the near infrared sensor monitors through an opening in the lens. In another embodiment, the sensor window is located in a region on the applicator 110 that is outside the portion of the applicator 110 that attached to the coupling bandage 130. [0045] In one embodiment, when the thermal cutoff 120 activates and turns off the applicator 110, for example, when the device is applied improperly or left turned on without being properly acoustically coupled to the body with the coupling bandage 130, an alert to the user can signal the cutoff. Alerts include, but are not limited to, a light on the device 100, including both visual, auditory, and other sensory alerts, including but not limited to, vibration. For example, one embodiment notifies a user of the activation of the cutoff 120 by illuminating a Light Emitting Diode (LED) error light, and triggering a vibration from the applicator 110. In embodiments where an alert can include vibration, the applicator 110 includes a vibration motor (not shown).

[0046] In an embodiment where more than one applicator 110 is connected to the power controller 170, the thermal cutoff features of the device may work individually for each applicator 110. For example, an embodiment can include a first applicator and a second applicator that are both coupled to the power controller and are transmitting simultaneously at different location on the body of a wearer. If the thermal cutoff in one of the applicators senses a temperature outside of the pre-configured range, that thermal cutoff will shut off that applicator. Meanwhile, the second applicator can continue operating In some embodiments, the controller 170 may monitor temperature around the surroundings of the applicator 110. For example, if the device is under clothing, the temperature may be higher in the device but lower at the skin surface. But, if the device is exposed to open air, the skin surface measurement may be higher. Thus, the controller 170 can intelligently control the applicator 110 to maximize performance by adjusting temperature thresholds and/or offsets based on the temperatures external to the device.

[0047] One or more applicators 110 deliver ultrasound to a wearer. An embodiment may include more than one applicator 110. The applicators 110 can each be preset to deliver, for example, 0.65 W at 3 MHz per applicator 110 (or other frequencies and powers). This embodiment enables the ultrasonic diathermy to be positioned on the body at various treatment locations. Each applicator 110 is positioned with a respective coupling bandage 130. In an embodiment when more than one applicator is coupled to the power controller, the applicators can each deliver ultrasound at the same or at different frequencies. In one embodiment, an applicator 110 is capable of multimodal operation, i.e., the applicator 110 can transmit ultrasound at two or more frequencies of operation, including but not limited to, frequencies from 20 kHz to 40 MHz

[0048] The applicator 110 may also operate in different specialized modes. For example, in a sensitive skin mode, the applicator 110 may transmit reduced output power from the transducer and pulse the ultrasonic drive signal or other mechanism to reduce heat accumulation.

[0049] In an embodiment where more than one applicator 110 is connected to the power controller 170, the applicators can be used together in order to attain a more effective penetration of the body of a wearer, including increasing the surface area that can be treated. For example, two or more applicators 110 can be placed at a position where the ultrasound transmitted from these applicators 110 creates constructive interference as beams overlap and create shear and/or longitudinal waves. The angle between the applicators contributes to type of transmissions. More than one applicator 110 can be utilized to simultaneously treat a region of the body in order to deliver more energy, but at a low profile on the body of the wearer.

[0050] In one embodiment, using more than one applicator can increase the therapeutic level of the treatment by multiples. For example, when applying ultrasound to certain parts of the body of a patient, at 1 cm from the application point, the signal is about five times weaker because the ultrasound is exponentially attenuated as it goes into tissue. If two applicators arc utilized at a spacing that provides constructive interference, at 1 cm, the signal loss can be cut in half. Thus, utilizing more than one applicator in a manner that created interference between the ultrasound waves being transmitted by each applicator delivers more energy to the wearer. Additionally, using two applicators allows more energy at deeper depths, but allows for less superficial heating than with treating with one higher power applicator.

[0051] As mentioned, an applicator 110 administers ultrasound, but also collects information during treatment, utilizing aforementioned monitoring capabilities. In one embodiment, an applicator 110 can obtain information including, but not limited to, skin temperature, applicator temperature, pulse oximetry, blood flow, blood oxygen content, mechanical elastography of the tissue, and/or other biometric information. For example, in one embodiment, the applicator 1 10 includes a touch free infrared heat sensor to monitor skin temperature during treatment.

[0052] In an embodiment where each individual applicator can collect this information and adjust ultrasound application based on this information, the individual applicators can also share information between them in order to adjust the overall treatment being received by the wearer. The activity of one applicator may influence the treatment administered by another applicator. In one embodiment, a power controller 170 powers two or more applicators 110 for example, to elicit deep therapeutic effects. Each applicator 110 receives information from the applicators (e.g., skin temperature, applicator temperature, pulse oximetry, and/or other biometric information) and changes the control sequence or ultrasonic drive signals based on this information. The individual applicators may be electrically connected to each other with a “Y” adapter cable, which connects the applicators to a cable from the power controller to connect to two or more applicators simultaneously. Thus, as the applicators are electrically coupled, the information collected by each applicator is accessible to the other applicators, such that a first applicator a can alter its ultrasound application based on the information collected by another applicator.

[0053] An applicator 110 may also include an acoustic spectroscopy sensor to measure sonic emissions from joints, tendons, ligaments, muscles and body tissues. This information can be utilized to alert a user to change in condition of the wearer to manually adjust treatment and/or can be used by control mechanisms in the applicator to adjust the treatment parameters. In one embodiment, the applicator 110 may actively pulse a transducer and measure the echogenicity coming back and see changes over hours, days, weeks, providing feedback on the changing echogenicity, including real-time feedback to user, for example, by displaying in simple format on a display on the applicator 110 (LED, LCD), and/or retaining the data in a memory in the applicator 110, such that it can be optionally downloaded off system utilizing a connection, such as a USB port.

[0054] In an embodiment with more than one applicator, one applicator a can be utilized to collect biometric information, while another applicator is used to administer ultrasound treatment. For example, an applicator a can record mechanical elastography by monitoring shear waves with an integrated receiving transducer (not pictured). In another embodiment, an applicator can include more than one transducer, including both transmitting and receiving transducers. In another example, one applicator can be utilized to collect information on echogenicity, as described earlier, while the second transducer is used to administer ultrasound at a different frequency. The first applicator may also include a proximity sensor to sense the location of the second applicator.

[0055] In a further embodiment, adjustment of controlling sequences for one or more applicators may be centralized to a common controller. This controller would obtain information from individual applicators and adjust control sequences for the individual applicators responsive to the collected information.

[0056] In one embodiment, the common controller may comprise a memory to retain the collected information. In a further embodiment, the individual controllers in the applicators may access either internal or external memory devices in order to retain the collected information.

[0057] In one embodiment, more than one applicator coupled to the power controller can sense feedback from ultrasound transmissions, for example, utilizing a receiving transducer integrated into the applicator to determine the location of one applicator relative to another applicator. This feature improves the quality of the treatment because a given applicator can determine whether it is too close to another applicator for effective therapy. In the case that one applicator is too close to another, the feedback to the transducer can trigger an alert, such as a sound, movement, or visual cue (e.g., light) from the applicator.

[0058] As mentioned, the embodiments include a power controller 170, which can be controlled by one or more integrated circuits (ICs). The power controller 170 provides user control of the device and delivers electrical power to the applicator(s) 110 with controlled, stable amplitude, for a defined period of time while also providing adaptive feedback temperature control to maintain temperatures during specific treatment segments. Aspects of the power controller 170 also enable the user to select treatment duration and provide user feedback.

[0059] FIG. 2 is a block diagram of a wearable diathermy device 200, in one exemplary embodiment. In this embodiment, the device 200 includes a power supply 202, a power distribution module 206, a controller 210, a transducer driver 208, a display module 216, a transducer 212, and one or more temperature sensors 214. Examples of the controller 210 include microcontrollers, microprocessors, application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), and the like. Such devices may include onboard memory and/or cache that may be configured with software instructions operable to control, among other things, the transducer driver 208 and the transducer 212. Preferably, the power supply 202 is configured as a battery such that the device 200 may be wearable. However, other embodiments may include a power supply that supplies alternating current (AC). The power distribution module 206 is operable to distribute power from the power supply 202 to the various components of the device 200.

[0060] Once powered on, the controller 210 may initiate a series of tests and selfcalibrations to prepare the device 200 for operation. Thereafter, during operation, the controller 210 may direct the transducer driver 208 to generate a drive signal that drives the transducer 212. For example, the transducer 212 may comprise a piezoelectric device which mechanically responds to an electric drive signal from the transducer driver 208. When being driven by the drive signal, the transducer 212 produces ultrasound waves. And when these ultrasound waves are placed in proximity to a user’s skin, heating occurs. This heating is part of the SAM as discussed above.

[0061] To ensure that the device 200 does not cause thermal damage to a user’ s skin and to ensure that the device 200 delivers maximum diathermy, the device 200 is configured with the temperature sensors 214 which provide a feedback loop to the controller 210 for adaptive control of the transducer 212. Thus, the controller is operable to control the transducer driver 202 to change the drive signal to the transducer 212 and thus change the frequency, intensity, and/or power emitted by the piezoelectric device of the transducer 212. For example, the controller 210 may determine whether the temperature at a certain portion of a treatment is above or below a threshold. If the temperature is below the threshold, the controller 210 may direct the transducer driver 208 to have the piezoelectric device of the transducer 212 to operate at a higher frequency, thereby increasing the temperature from the device 200. If the temperature is above the threshold, the controller 210 may direct the transducer driver 208 to have the piezoelectric device of the transducer 212 operate at a lower frequency, thereby decreasing the temperature from the device 200. Generally, the controller 210 modulates the on-status of the transducer versus frequency to manage heating. But, the controller 210 can also modulate frequency, power, intensity, and/or pulse rate to manage heating. For example, the controller 210 may modulate the temperature delivered to a user by modulating the power, intensity, and/or frequency of the drive signal applied to the transducer.

[0062] In some embodiments, one or more of the temperature sensors 214 may be configured on the backside of the applicator, such as the applicator 110 of FIG. 1. These sensors would be configured to monitor thermodynamics across the transducer and in various locations which may be random or geographically symmetrical (e.g., such as on a radius from the center of a circular transducer disc). Other temperature sensors are configured on multiple locations of the user facing surface of the applicator to monitor the temperature of the user under treatment. In some embodiments, there are one or more temperature sensors that are operable to measure surrounding ambient temperature of the transducer. Generally, the temperature sensors 214 can be configured at multiple locations of the applicator and even include an entire surface of the applicator for integration and adaptation of ultrasound outputs. Various modes of transducer excitation generally impact temperature distribution of the piezoelectric device so as to modulate a temperature profile on the patient.

[0063] The temperature monitoring by the controller 210 allows the controller 210 to inform the transducer driver 208 to regulate ultrasound delivery to the user. In this regard, the controller 210 can adaptively control ultrasound output to not exceed certain thresholds (i.e., above or below) for any portion of a particular treatment. For example, one treatment for a patient may include multiple thresholds such as temperature one, temperature two, temperature three, etc. Each temperature threshold may be registered to a particular location on the transducer 212, such as the transducer 212 itself, the local ambient environment, forward facing temperature probes embedded in the ultrasound transducer housing that touches the skin of the user, etc. The feedback from the temperature sensors 214 provides information for the controller 210 to throttle up ultrasound output to achieve desired temperature level, throttle back output to prevent exceeding temp-level, and turn off output in case of an over temp condition. [0064] The controller 210 generally includes a combination of software and firmware that provides intelligent regulation of the transducer 212 so as to provide multiple safety defaults and maximum ultrasound delivery, including an auto shut off during a fault procedure. The controller 210 is also operable to measure ultrasound coupling and the total joules of ultrasound of energy delivered to the patient in real time during a particular treatment to determine whether the desired energy dose is provided. This can result in the controller 210 automatically lengthening a particular treatment to achieve the desired total dose/joules of energy and/or to provide information to the user and/or a medical provider to determine whether additional treatment is required. In this regard, the controller 210 may present the total dosage of energy delivered to the user via the display 216. And, the controller 210 may include a communications module that is operable to convey the dosage information and/or temperature information to a medical provider such that the medical provider can remotely monitor the user during and/or after a particular treatment session. Examples of communication technologies that the controller 210 may include cellular telephony, Bluetooth, Wi-Fi, etc.

[0065] In some embodiments, the device 200 is configured with LEDs and/or tactile feedback to inform the user that the device is operating in the SAM zone. In some embodiments, an LED may be configured with the device 200 to provide skin-device interface to provide targeted light and ultrasound therapy. For example, the controller 210 may modulate light from the LED according to the pulsing of the ultrasound therapy to provide direct user feedback regarding a mode of action of the device 200 because the user can see light but not ultrasound waves. The controller 210 may also regulate the light intensity and ultrasound pulses facing the patient. In some embodiments, the device 200 provides an outer glow through translucence of a lens of the transducer and the coupling patch to provide a reflective ring and bio feedback indicating where the device 200 is providing treatment. The device 200 may even implement a color scheme of the LED(s) to focus on ultrasound frequency, pulse mode, intensity, and the like.

[0066] In some embodiments, the device 200 may determine a type of patch that is being used. For example, the applicator 110 may be configured in a variety of shapes and sizes to accommodate different sized people and/or localize therapy to a particular body part of a user. In this regard, the device 200 may connect to the applicator 110 to provide different types of treatment, such as modulating ultrasound frequency, adaptive treatment, a drug patch that starts with the applicator 1 10 providing a lower frequency for permeabilization followed by higher frequency for acoustic streaming, etc. The applicator 110 may be modulated between about 1 and 3 MHz to maximize deep therapeutic heating effects. Whereas another applicator 110 may be configured as a bone-healing patch that would be pulsed at 1.5 MHz for fracture repair. Based on the connection, the controller 210 may determine which type of therapy to perform.

[0067] In some embodiments, the device 200 may be operable to monitor tissue properties and/or transducer impedance to provide a feedback that correlates to temperature. For example, the controller 210 may measure bioimpedance of the user through the applicator 110 to detect a change in the speed of sound of the pulses being delivered to the user. The speed of sound may correspond to a change in temperature. And, a dramatic change in the speed of sound/temperature, may be representative of a coagulation event. Thus, the controller 210 may distinguishing pulses to measure time of flight between pulses and thus detect temperature change to prevent coagulation events from happening.

[0068] In some embodiments, the device 200 may be configured with a pulse oximeter to measure circulation using near infrared spectroscopy. Based on the measured circulation, the controller 210 may adjust the temperature being delivered to the user (e.g., via the various techniques described herein).

[0069] FIG. 3 is a flowchart of a process 300 for delivering SAM to a body part of a user, in one exemplary embodiment. In this embodiment, the process 300 initiates when the device is turned on the controller 210 directs the transducer driver 208 to generate a drive signal to drive the transducer 212 to deliver ultrasound radiation to a body part of a user, in the process element 302. The temperature sensors 214 of the wearable diathermy device 200 then sense temperature changes in the transducer 212, in the process element 304. With this feedback, the controller 210 determines whether the temperature at the transducer 212 is at a threshold temperature during a particular portion of a treatment, in the process element 306. If the temperature is at the correct threshold, then the controller 210 continues to monitor the temperature from the temperature sensors 214, in the process element 304. Otherwise, the controller 210 may determine whether the temperature is below a particular threshold during the treatment, in the process element 308. If so, the controller 210 directs the transducer driver 202 to increase the drive to the transducer 212, thereby increasing the acoustic frequency of the transducer 212, in the process clement 310. This has the effect of increasing the temperature being applied to the user. Otherwise, if the temperature is above the desired threshold, the controller 210 may direct the transducer driver 208 to decrease the drive to the transducer 212, thereby decreasing the acoustic frequency of the transducer 212, in the process element 312. This has the effect of decreasing the temperature being applied to the user. As the temperature of the user and/or the transducer 212 can vary over time during a treatment, the controller 210 can adaptively control the temperature to the user and/or the transducer 212 by continuously monitoring the temperatures of each and reacting accordingly. Generally, the controller 210 is operable to maintain a temperature within a range of about +/- 1° C via adaptive control of the piezoelectric device in the transducer 212.

[0070] Additionally, the temperature thresholds can change over a treatment duration depending on a treatment by a medical provider. For example, a first segment of time in a treatment may include one particular upper and lower threshold, a second segment of time may include another particular upper and lower threshold, etc. The controller 210 is operable to read the thresholds over time so as to ensure that the device 200 is operating as directed.

[0071] FIG. 4 is a graph 400 illustrating the temperature control of the wearable diathermy device 200, in one exemplary embodiment. Here, the controller 210 is operable to gradually “ramp up” the temperature of the wearable diathermy device 200 via the modulation of the piezoelectric device in the transducer 212, as illustrated with plot 402. The graph 400 also shows a previous technology in the plot 404 which illustrates a more sudden ramp-up of the temperature with less control over a desired temperature range. As can be seen in the graph 400, this newer technology of the embodiments herein provides a smoother ramp-up with less temperature swings over a treatment duration.

[0072] FIGS. 5A-5D are graphs 500 that illustrate the temperature control at an applicator, such as the applicator 110 of FIG. 1, by the modulation of the piezoelectric device in the transducer 212. In FIG. 5A, the graph 500 the controller 210 being operable to control the driver signal from the transducer driver 208 to gradually ramp up the temperature at the applicator so as to maintain a relatively constant temperature being applied to the user during a particular part of a treatment, as shown with plot 502. Plot 504 illustrates a prior technology having less control over the temperature, resulting in temperature swings being applied to the user during a treatment. It can be seen in plot 502, the controller 210 can maintain a consistent heating level across the heating peaks of the prior technology.

[0073] Of course, the controller 210 is also operable to maintain consistent heating levels as desired. For example, FIG. 5B illustrates the plot 506 in which the controller 210 can maintain a consistent heating level across the minimum heating peaks of the prior technology. In FIG. 5C, the plot 508 illustrates the controller 210 maintaining a consistent heating level across the average of the heating swings of the prior technology. And, in FIG. 5D, the plot 510 illustrates the controller 210 maintaining a consistent heating level until the controller 210 determines that a shift in temperature is necessary (e.g., from high to low), such as when a particular dosage of SAM has been reached, when a known temperature damage threshold can be breached at a particular time, or the like. Accordingly, the embodiments herein are not intended to be limited to any particular consistent heating level. Rather, these embodiments illustrate how the controller 210 is operable to control heating via the adaptive control of the transducer 212.

[0074] FIG. 6 is a graph 600 that illustrates various depths of diathermy penetration into a user’ s body when the wearable diathermy device is performing a treatment on the user, in one exemplary embodiment. Plot 602 illustrates the diathermy penetration at 1 cm into the user’s body. Plot 604 illustrates diathermy penetration at 3 cm into the user’s body. And, plot 606 illustrates the diathermy penetration at 5 cm into the user’s body. Each of these plots illustrates that the controller 210 is operable to maintain relatively constant penetrations in the user’s body through ramp-up of the treatment, through treatment, and through ramp down of the treatment.

[0075] FIG. 7 is a flowchart of a process 700 for initiating the wearable diathermy device 200, in one exemplary embodiment. In this embodiment, the process 700 initiates when the device 200 is turned on and the power supply 202 provides power to the device 200 to start the wearable diathermy device 200, in the process element 702. From there, the controller 210 and initializes hardware ports and variables (e.g., SAM treatment zones, temperature thresholds, etc.), in the process element 704. The controller 210 may then determine whether the device 200 has been reset, in the process element 706. If so, the controller 210 may reset the device 200 to its factory defaults, in the process element 708, and the controller 210 turns off the LEDs and alarm in the process element 710. Otherwise, the controller 210 turns off the LEDs and alarms, in the process element 710, and reads the stored reset information, in the process element 712.

[0076] FIG. 8 is a flowchart of a process 800 for calibrating the wearable diathermy device 200, in one exemplary embodiment. In this embodiment, the controller 210 determines whether the device 200 has been reset to the factory defaults, in the process element 802. If so, the controller 210 initiates the LEDs and the alarm and resets memory (e.g., an electrically erasable programmable read only memory, or EEPROM) to factory defaults, in the process element 804. In this step, the controller 210 may wait one second and turn the red LED (e.g., fault detection) and the alarm off. Afterwards, the controller 210 reads a number of test performed on the wearable diathermy device 200, increments the test number, and stores that in the memory, in the process element 806. If the wearable diathermy device 200 has not been reset to factory defaults, the controller 210 implements the process element 806. Afterwards, the controller 210 reads the memory for a stored target offset, in the process element 808. The target offset is set to ensure a proper degree reading. The target offset is stored as roughly 45 bits per degree so that it may be multiplied by two to arrive at a correct 90 bits per degree per read value.

[0077] If the target offset has been incremented to a particular limit (e.g., 255), the target offset may be deemed invalid, in the process element 810. Thus, the controller 210 may establish that the wearable diathermy device 200 is not calibrated by establishing a “not yet calibrated” flag, in the process element 812. Then, the controller 210 scales the target offset by two, in the process element 814. If the target offset is not invalid, the controller 210 proceeds to the process element 814. Thereafter, the controller establishes the target threshold as the minimum threshold plus the target offset, in the process element 816. This calibration ensures that the device makes it to the maximum temperature allowed by the resistor. This provides an indication to the device as to what temperatures to modulate to, and what temperatures to display during the SAM sensing mode. Then, the controller 210 establishes the SAM threshold as the target threshold -10° C, and the SOT (i.e., “Software Over Temperature”) threshold as the target threshold +.9° C, in the process element 818. When the SOT is passed, the controller 210 may turn off power to the piezo to reduce temperature. Then the controller 210 enters the main loop of operation, in the process element 820. [0078] FTG. 9 is a flowchart of a process 900 that illustrates a main loop of operation of the wearable diathermy device 200, in one exemplary embodiment. Here, after the device 200 has been reset and calibrated, the controller 210 enters the main loop, in the process element 820, and then reads and averages the temperatures from the temperature sensors 214, in the process element 902. The controller 210 then compares the average temperature to the temperature thresholds, in the process element 904, and increments a loop counter, in the process element 906. The controller 210 then determines whether the loop counter is greater than or equal to some threshold (e.g., eight increments), in the process element 908. If the loop counter is less than the threshold, the controller 210 restarts the loop counter, in the process element 914. Otherwise, the controller 210 sets the loop counter to zero and initiates a clock that increments by the second for a duration of the treatment, in the process element 910. The controller 210 then periodically stores the time and flash temperature (e.g., every 15 seconds), in the process element 912.

[0079] FIG. 10 is a flowchart of a process 1000 that is a continuation of the process 900 of FIG. 9, in one exemplary embodiment. Here, the controller 210 begins ramping up heating by driving the transducer 212. In doing so, the controller 210 reads and averages the temperature of the wearable diathermy device 200, in the process element 1002. The controller 210 then sets the counter to zero and the average temperature to zero, in the process element 1004. Afterwards, the controller 210 determines whether the counter is greater than or equal to some threshold (e.g., 10 increments), in the process element 1006. If not, the controller 210 increments a counter, waits for some period of time (e.g., 5 ms) and reads an ADC (i.e., Analog to Digital Converter) that is used to convert analog temperature from the temperature sensors into digital temperature data, in the process element 1008. The controller 210 then establishes the temperature threshold as the ADC minus some ° C offset, in the process element 1010, and establishes the average temperature to be equal to the average plus the newly read temperature, in the process element 1012. The controller 210 then returns to the process element 106 to complete the loop. If the counter of process element 1006 is greater than or equal to the threshold, the controller 210 then establishes the average temperature, in the process element 1014, and the warming ramp up is complete in the process element 1016. [0080] FIG. 11 is a flowchart of a process 1100 that illustrates the temperature control during operation wearable diathermy device 200, in one exemplary embodiment. In this embodiment, the controller 210 checks the temperature threshold during a time segment of the treatment duration in which the device 200 is operating, in the process element 1102. Here, the controller 210 establishes the temperature to be the average temperature and the expiring temperature to be the expiring temperature plus the temperature divided by two (i.e., (Exp Temp +Temp)/2), in the process element 1104. The controller 210 then determines whether the temperature is greater than the peak temperature, in the process element 1106. If so, the controller 210 establishes the peak temperature as the temperature, in the process element 1108. If not, the controller 210 determines whether the temperature is at an over temperature, in the process element 1110. If so, the controller 210 may pause heating (i.e., by driving the transducer 212 slower), in the process element 1112. For example, if the device is in a hardware over temperature state, the device waits until it leaves hardware over temperature state. Otherwise, the controller 210 determines the hardware overtemperature states based on the resistor value, in the process element 1114. The controller 210 may then drives the transducer 212 to a new temperature, in the process element 1116. Otherwise, the controller 210 determines whether the device 200’s calibration flag has been set, in the process element 1118. If so, the controller 210 determines that the device 200 is not yet calibrated, in the process element 1120. If no hardware overtemperature flag has been set, the device is in a calibration mode, which generally only occurs the first time being on after programming the device.

[0081] FIG. 12 is a flowchart of a process 1200 for determining whether the wearable diathermy device 200 is operating in the desired zone to provide a SAM dose, in one exemplary embodiment. In this embodiment, the controller 210 determines whether the temperature is below the SAM zone, in the process element 1202. If so, the controller 210 initiates warming of the device 200 and toggles blue LEDs on such that they indicate that the device 200 is operating in the proper zone, in the process element 1204. In this regal'd, the controller 210 may turn the red lights and alarms off and initiate the transducer driver 208 to generate a drive signal that drives the transducer 212 to peak power until the device 200 in operating in the SAM zone.

[0082] Once the device 200, is operating in the SAM zone, the controller 210 continues driving the transducer 212 in the same fashion, indicating that the device 200 is operating in the SAM zone with the blue LEDs on, the red LED off, and the alarm off, in the process element 1206. Thereafter, the controller 210 continually monitors the temperature sensors 214 to determine whether the temperature is below the target temperature to ensure that the maximum diathermy dose is applied to the user. This process is illustrated in the flowchart 1300 of FIG. 13.

[0083] FIG. 13 is a flowchart of a process 1300 illustrating when the wearable diathermy device 200 is operating in the SAM zone, in one exemplary embodiment. Here, the controller 210 has determined that the device 200 is operating in the SAM zone, in the process element 1302. Then, the controller 210 continually monitors the temperature sensors 214 to determine whether the temperature is below a target temperature, in the process element 1304. If so, the controller 210 directs the transducer driver 208 to drive the transducer 212 to full power, in the process element 1306. Otherwise, if the temperature is above the Exp average temperature as established above, in the process element 1308, the controller 210 determines whether the temperature is above the target temperature +0.5° C, in the process element 1310. If so, the controller 210 directs the transducer driver 208 to reduce the drive signal to the transducer 212, in the process element 1312. Otherwise, the controller 210 directs the transducer driver 208 to reduce the power to some other level, in the process element 1314, to gradually adjust the temperature of the device 200. If the temperature is below the expected average temperature, the controller 210 determines whether the temperature is below the target +0.5° C Celsius, in the process element 1316. If so, the controller 210 directs the transducer driver 208 to increase the drive signal to the transducer 212 to full power, in the process element 1318. Otherwise, the controller 210 increases the power by directing the transducer driver 208 to gradually increase the drive signal to the transducer 212, in the process element 1320.

[0084] FIG. 14 is a flowchart of a process 1400 that continues the process 1300 of FIG. 13, in one exemplary embodiment. Here, the controller 210 checks the loop counter to determine whether the loop counter is greater than the power being applied, in the process element 1402. If so, the treatment is complete and oscillation of the transducer 212 is turned off by the controller 210 turning off the transducer driver 208, in the process element 1406. Otherwise, the controller 210 continues directing the transducer driver 208 to apply the drive signal to the transducer 212 until the dosage is complete (i.e., by returning to the process element 1402), in the process clement 1406.

[0085] In FIG. 15, one illustrative cloud computing system 1500 is illustrated and is operable to perform the above operations by executing programmed instructions tangibly embodied on one or more computer readable storage mediums. The cloud computing system 1500 generally includes the use of a network of remote servers hosted on the internet to store, manage, and process data, rather than a local server or a personal computer (e.g., in the computing systems 1502-1 - 1502-N). Cloud computing enables users to use infrastructure and applications via the internet, without installing and maintaining them on-premises. In this regard, the cloud computing network 1520 may include virtualized information technology (IT) infrastructure (e.g., servers 1524-1 - 1524-N, the data storage module 1522, operating system software, networking, and other infrastructure) that is abstracted so that the infrastructure can be pooled and/or divided irrespective of physical hardware boundaries. In some embodiments, the cloud computing network 1520 can provide users with services in the form of building blocks that can be used to create and deploy various types of applications in the cloud on a metered basis.

[0086] In one embodiment, instructions stored on a computer readable medium direct a computing system of any of the devices and/or servers discussed herein to perform the various operations disclosed herein. In some embodiments, all or portions of these operations may be implemented in a networked computing environment, such as a cloud computing system. Cloud computing often includes on-demand availability of computer system resources, such as data storage (cloud storage) and computing power, without direct active management by a user. Cloud computing relies on the sharing of resources, and generally includes on-demand self-service, broad network access, resource pooling, rapid elasticity, and measured service.

[0087] Various components of the cloud computing system 1500 may be operable to implement the above operations in their entirety or contribute to the operations in part. For example, a computing system 1502-1 may be used to perform all or portions of the operations of the embodiments herein, and then store results in a data storage module 1522 (e.g., a database) of a cloud computing network 1520. Various computer servers 1524-1 - 1524-N of the cloud computing network 1520 may be used to operate on the data and/or transfer analysis of the data and/or the data to another computing system 1502-N.

[0088] Some embodiments disclosed herein may utilize instructions (e.g., code/software) accessible via a computer-readable storage medium for use by various components in the cloud computing system 1500 to implement all or parts of the various operations disclosed hereinabove. Examples of such components include the computing systems 1502-1 - 1502-N.

[0089] Exemplary components of the computing systems 1502-1 - 1502-N may include at least one processor 1504, a computer readable storage medium 1514, program and data memory 1506, input/output (VO) devices 1508, a display device interface 1512, and a network interface 1510. For the purposes of this description, the computer readable storage medium 1514 comprises any physical media that is capable of storing a program for use by the computing system 1502. For example, the computer-readable storage medium 1514 may be an electronic, magnetic, optical, electromagnetic, infrared, semiconductor device, or other non-transitory medium. Examples of the computer-readable storage medium 1514 include a solid-state memory, a magnetic tape, a removable computer diskette, a random access memory (RAM), a read-only memory (ROM), a rigid magnetic disk, and an optical disk. Some examples of optical disks include Compact Disk - Read Only Memory (CD-ROM), Compact Disk - Read/Write (CD- R/W), Digital Versatile Disc (DVD), and Blu-Ray Disc.

[0090] The processor 1504 is coupled to the program and data memory 1506 through a system bus 1516. The program and data memory 1506 include local memory employed during actual execution of the program code, bulk storage, and/or cache memories that provide temporary storage of at least some program code and/or data in order to reduce the number of times the code and/or data are retrieved from bulk storage (e.g., a hard disk drive, a solid state drive, or the like) during execution.

[0091] Input/output or VO devices 1508 (including but not limited to keyboards, displays, touchscreens, microphones, pointing devices, etc.) may be coupled either directly or through intervening VO controllers. Network adapter interfaces 1510 may also be integrated with the system to enable the computing system 1502 to become coupled to other computing systems or storage devices through intervening private or public networks. The network adapter interfaces 1510 may be implemented as modems, cable modems, Small Computer System Interface (SCSI) devices, Fibre Channel devices, Ethernet cards, wireless adapters, etc. Display device interface 1512 may be integrated with the system to interface to one or more display devices, such as screens for presentation of data generated by the processor 1504.

[0092] Any of the above embodiments herein may be rearranged and/or combined with other embodiments. Accordingly, the concepts herein are not to be limited to any particular embodiment disclosed herein. Any of the various computing and/or control elements shown in the figures or described herein may be implemented as hardware, as a processor implementing software or firmware, or some combination of these. For example, an element may be implemented as dedicated hardware. Dedicated hardware elements may be referred to as “processors,” “controllers,” or some similar terminology. When provided by a processor, the functions may be provided by a single dedicated processor, by a single shared processor, or by a plurality of individual processors, some of which may be shared. Moreover, explicit use of the term “processor” or “controller” should not be construed to refer exclusively to hardware capable of executing software, and may implicitly include, without limitation, digital signal processor (DSP) hardware, a network processor, application specific integrated circuit (ASIC) or other circuitry, field programmable gate array (FPGA), read only memory (ROM) for storing software, random access memory (RAM), non-volatile storage, logic, or some other physical hardware component or module. Some examples of software include but are not limited to firmware, resident software, microcode, etc.

[0093] FIG. 16 is a block diagram of a system 1600 operable to monitor a SAM device 1610, such as that shown and described in FIG. 1, delivering a SAM dosage, in one exemplary embodiment. In this embodiment, a SAM device 1610 is affixed to a user’s knee and treatment with the SAM device 1610 is in progress. As mentioned, the SAM device 1610 may be configured with a communication module that is operable to communicate data pertaining to the SAM dosage to any of a variety of components. For example, the SAM device 1610 may communicate the SAM treatment to an “app” on the user’s personal device 1604 (e.g., a cell phone, a tablet computer, a laptop computer, etc.) such that the user can monitor the user’s SAM treatment through the user interface 1606 as the treatment progresses. The user interface 1606 may indicate to the user that the devices operating in or out of the SAM zone and/or how far along the treatment has progressed.

[0094] In some embodiments, the SAM device 1610 is operable to communicate also to a network 1620 which may in turn communicate to a server 1626 of a medical service provider who can monitor the SAM treatment the user is undergoing (e.g., via a personal device or computer of the medical service provider). Alternatively or additionally, the user’s personal device 1604 may communicate the information to the network 1620.

[0095] In some embodiments, the SAM device 1610 is also configured with tactile components and/or LEDs which may provide indications to the user about the treatment while the treatment is in progress. For example, the SAM device 610 may include a plurality of LEDs that glow in various colors to indicate a level and/or progress of the SAM treatment the user is undergoing as illustrated by the arrows 1612.

Claims

Claims What is claimed is:

1. A wearable diathermy device operable to deliver sustained acoustic medicine (SAM) to a body part of a user, comprising: a transducer comprising a piezoelectric device operable to deliver ultrasound radiation to the body pail of the user; one or more temperature sensors operable to sense temperature changes in the transducer; and a controller communicatively coupled to the transducer and the one or more temperature sensors, the controller being operable to drive the piezoelectric device, to monitor the temperature changes via the one or more temperature sensors, and to adjust a drive signal to the piezoelectric device when a sensed temperature from the one or more temperature sensors reaches a threshold temperature.

2. The wearable diathermy device of claim 1, wherein: the controller is further operable to maintain a desired temperature within a range of about +/- 1° C via adaptive control of the piezoelectric device.

3. The wearable diathermy device of claim 1, wherein: the controller is further operable to determine an amount of energy delivered to the body part of the user during a treatment.

4. The wearable diathermy device of claim 3, further comprising: a display configured with the wearable diathermy device or a personal device of the user, the display being operable to display the amount of energy delivered to the body part of the user during the treatment.

5. The wearable diathermy device of claim 1 , wherein: the controller is further operable to determine an average temperature of the transducer from the one or more temperature sensors.

6. The wearable diathermy device of claim 1, wherein: the controller is further operable to increase an energy output of the piezoelectric device when the sensed temperature is below the threshold temperature.

7. The wearable diathermy device of claim 1, wherein: the controller is further operable to decrease an energy output of the piezoelectric device when the sensed temperature is above the threshold temperature.

8. The wearable diathermy device of claim 1, wherein: at least one of the one or more temperature sensors is an optical sensor.

9. The wearable diathermy device of claim 1, further comprising: one or more light emitting diodes (LEDs) operable to provide an illuminated indication of a SAM treatment to the user.

10. The wearable diathermy device of claim 1, further comprising: one or more tactile components operable to provide a vibratory indication of a SAM treatment to the user.

11. The wearable diathermy device of claim 1, further comprising: a communication module operable to convey diathermy dosage information of the user to a medical provider.

12. A method of delivering sustained acoustic medicine (SAM) to a body part of a user, the method comprising: with a wearable diathermy device, driving a transducer comprising a piezoelectric device to deliver ultrasound radiation to a body part of a user; sensing temperature changes in the transducer with one or more temperature sensors configured with the wearable diathermy device; and adjusting a drive signal to the piezoelectric device when a sensed temperature from the one or more of the temperature sensors reaches a threshold temperature.

13. The method of claim 12, wherein: maintaining a desired temperature within a range of about +/- 1° C via adaptive control of the piezoelectric device.

14. The method of claim 12, further comprising: determining an amount of energy delivered to the body part of the user during a treatment.

15. The method of claim 14, further comprising: displaying the amount of energy delivered to the body part of the user during the treatment.

16. The method of claim 12, further comprising: determining an average temperature of the transducer from the one or more temperature sensors.

17. The method of claim 12, further comprising: adjusting a drive signal to the piezoelectric device comprises increasing an energy output of the piezoelectric device when the sensed temperature is below the threshold temperature.

18. The method of claim 12, further comprising: adjusting a drive signal to the piezoelectric device comprises decreasing an energy output of the piezoelectric device when the sensed temperature is above the threshold temperature.

19. The method of claim 12, wherein: at least one of the one or more temperature sensors is an optical sensor.

20. The method of claim 12, further comprising: providing an illuminated indication of a SAM treatment to the user via one or more light emitting diodes (LEDs) configured with the wearable diathermy device.

21. The method of claim 12, further comprising: providing a vibratory indication of a SAM treatment to the user via one or more tactile components configured with the wearable diathermy device.

22. The method of claim 12, further comprising: conveying diathermy dosage information of the user to a medical provider via a communication module of the wearable diathermy device.

23. A non-transitory computer readable medium comprising instructions that, when executed by a controller of a wearable diathermy device, direct the controller to deliver sustained acoustic medicine (SAM) to a body pail of a user, the instructions for the directing the controller to: drive a transducer comprising a piezoelectric device to deliver ultrasound radiation to a body part of a user; sense temperature changes in the transducer with one or more temperature sensors configured with the wearable diathermy device; and adjust a drive signal to the piezoelectric device when a sensed temperature from the one or more of the temperature sensors reaches a threshold temperature.

24. The computer readable medium of claim 23, further comprising instructions that direct the controller to: adjust a drive signal to the piezoelectric device by increasing an energy output of the piezoelectric device when the sensed temperature is below the threshold temperature.

25. The computer readable medium of claim 23, further comprising instructions that direct the controller to: adjust a drive signal to the piezoelectric device by decreasing an energy output of the piezoelectric device when the sensed temperature is above the threshold temperature.