Patent Publication Number: US-11045647-B2

Title: Pulsed electromagnetic field tissue stimulation treatment and compliance monitoring

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation of U.S. patent application Ser. No. 15/783,072, filed Oct. 13, 2017, which claims priority to and the benefit of the U.S. Provisional Patent Application No. 62/409,014, filed Oct. 17, 2016, each of which is hereby incorporated by reference in their entirety as if fully set forth below in their entirety and for all applicable purposes. 
    
    
     TECHNICAL FIELD 
     The present description relates to systems, apparatus, and methods of tissue engineering to enhance the growth of musculoskeletal tissues by monitoring treatment remotely to ensure compliance with prescribed treatment regimens. 
     BACKGROUND 
     An approach to treating various types of musculoskeletal issues involves applying pulsed electromagnetic fields (PEMF) to the general areas of the body where the musculoskeletal issues exist. PEMF involves low-energy, time-varying pulses of magnetic fields. PEMF is therapeutic to various issues including fractures, spinal fusion, ligament injuries, tendon injuries, and osteoporosis as just a few examples. PEMF has been clinically observed to benefit in stimulating tissue differentiation and/or tissue generation when performed according to prescribed measures (i.e., duration of treatment per use, intensity of treatment, number of uses over time, etc.). 
     A challenge arises, however, in ensuring patient compliance with prescribed measures in the treatment regimen so as to achieve the desired therapeutic outcome. At best, the physician tasked with treating the musculoskeletal issue can monitor whether the tissue engineering device (that provides the PEMF treatment) was activated in a given day or not. But this is not always tantamount to the patient actually complying with the treatment regimen. For example, the tissue engineering device may be turned on but not actually applied to the tissue of the patient (e.g., activated and left on a chair, tabletop, etc.). 
     This can result in significantly degraded treatment outcomes, whether by delaying the efficacy of treatment over time or generally causing sub-par results. A need exists to improve the clinical success rate of PEMF tissue engineering devices when treating musculoskeletal tissue according to proven regimens, all while still providing an energy-efficient tissue engineering device that is convenient for the patient to use so as to facilitate prescribed use. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present disclosure is best understood from the following detailed description when read with the accompanying figures. 
         FIG. 1  is an organizational diagram of an exemplary treatment and monitoring system architecture according to aspects of the present disclosure. 
         FIG. 2  is an organizational diagram of an exemplary tissue engineering device according to aspects of the present disclosure. 
         FIG. 3  is an organizational diagram of an exemplary user device according to aspects of the present disclosure. 
         FIG. 4  is an organizational diagram of an exemplary server apparatus according to aspects of the present disclosure. 
         FIG. 5  is a protocol diagram illustrating exemplary aspects between treatment and monitoring system elements according to aspects of the present disclosure. 
         FIG. 6  is a flowchart illustrating an exemplary method for tissue treatment and monitoring according to aspects of the present disclosure. 
         FIG. 7A  is a flowchart illustrating an exemplary method for tissue treatment device sensor polling according to aspects of the present disclosure. 
         FIG. 7B  is a flowchart illustrating an exemplary method for tissue treatment device compliance monitoring according to aspects of the present disclosure. 
         FIG. 8  is a flowchart illustrating an exemplary method for tissue treatment device compliance monitoring according to aspects of the present disclosure. 
         FIG. 9  is a flowchart illustrating an exemplary method for tissue treatment device compliance monitoring according to aspects of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     All examples and illustrative references are non-limiting and should not be used to limit the claims to specific implementations and embodiments described herein and their equivalents. For simplicity, reference numbers may be repeated between various examples. This repetition is for clarity only and does not dictate a relationship between the respective embodiments. Finally, in view of this disclosure, particular features described in relation to one aspect or embodiment may be applied to other disclosed aspects or embodiments of the disclosure, even though not specifically shown in the drawings or described in the text. 
     Various embodiments include systems, methods, and machine-readable media for tissue engineering to enhance the growth of musculoskeletal tissues by monitoring treatment remotely to ensure compliance with prescribed treatment regimens. A tissue engineering device that provides treatment to one or more musculoskeletal tissues of a patient is equipped with networking devices that allow it to connect with one or more devices. For example, the tissue engineering device is capable of pairing with another device, identified as a user equipment (UE) herein, such as via a Bluetooth, wired, or near field communication technology. The tissue engineering device is further equipped with one or more sensors that monitor different aspects of operation of the tissue engineering device. The data obtained from the sensors (historical usage data and/or current usage data, for example) may be used to determine a level of compliance in use of the tissue engineering device with a prescribed treatment regimen for the patient. 
     Over time, the sensors&#39; monitored data is transferred to the UE when the UE pairs with the tissue engineering device. The UE relays the monitored data, typically stripped of patient identifying information in some embodiments (and/or encrypted), to a remote server. The remote server may maintain a database of different patient profiles associated with tissue engineering devices and prescribed treatment regimens. As the monitoring data is received at the remote server, the remote server associates the data with the proper patient profile and stores the monitoring data as part of that profile. Periodically, the remote server generates a compliance report for that patient based on the monitoring data aggregated in the database. This compliance report may identify a level of compliance, and details associated therewith, of the use of the tissue engineering device for the patient to the prescribed treatment regimen. The remote server may send, or otherwise make available, the compliance report to one or more subscribing access devices (e.g., associated with the physician or other interested parties). 
     Further, the UE that pairs with the tissue engineering device may also maintain a calendar for treatment based on the prescribed treatment regime as well as provide for other maintenance. For example, reminders may be set in the calendar for treatment. During a given treatment period (e.g., a day), the UE may track monitoring data as it is received from the tissue engineering device and use that to modify any scheduled reminder (e.g., to change the content of the reminder, an intensity of the reminder, etc.). In this manner, the UE may dynamically adjust the reminders to the prevailing conditions of use for the given periodic application of treatment. Further, the UE may provide contact information for the prescribing physician, healthcare provider, and/or a representative for the manufacturer of the tissue engineering device, as well as links to one or more online access systems such as one that allows the patient to modify their identifying information in the remote server&#39;s database. 
     The prescribing physicians, by accessing the compliance reports, may send messages to the patient to encourage improved compliance and/or other important information, as well as provide additional data points on which to base changes to the prescribed treatment regimen. The messages/updates to the treatment regimen may be submitted via an access portal to the remote server. The remote server may update its records and forward the message/update to the UE and the tissue engineering device. 
     As a result of the foregoing, embodiments of the present disclosure improve the field of pulsed electromagnetic field therapy for tissue engineering, such as for tissue differentiation and/or growth stimulation of tissue. In particular, embodiments of the present disclosure improve the transparency of treatment compliance so that more efficacious treatment regimens may be provided and prescribed to patients, whether at the onset of treatment or dynamically during treatment. The tissue engineering device itself may therefore be tuned to operate more efficiently for a given indication within a prescribed period of time as is now otherwise possible. This may therefore further improve clinical success rates of tissue engineering devices while still providing an energy-efficient tissue engineering device that is convenient for the patient to use according to prescribed usage. 
       FIG. 1  illustrates an organizational diagram of an exemplary treatment and monitoring system architecture  100  according to aspects of the present disclosure. The treatment and monitoring system architecture  100  may include one or more tissue engineering devices  102 , one or more user equipment (“UE,” also referred to herein as user devices)  104 , a wireless network  106 , a remote server  108 , a remote server  110 , a network  112  (that may be part of or separate from the wireless network  106 ), and one or more access devices  114  (also referred to herein as subscribing devices). 
     The tissue engineering device  102  may be a PEMF device or an ultrasound device, a combined magnetic field device, or a direct current device to name some examples of tissue engineering devices to which embodiments of the present disclosure apply. The tissue engineering device  102  provides therapeutic treatment (e.g., PEMF or ultrasound, a combination, etc.) to musculoskeletal tissues of a patient. As used herein, musculoskeletal tissue may refer to any of a variety of tissues of a patient, including bone tissue, tendons, cartilage, etc., and/or some combination thereof. The tissue engineering device  102  may be designed and manufactured to provide specific forms of treatment to specific tissues, for example to treat fractures of bones of a patient, or as an adjunctive treatment option for cervical fusion, or spinal fusion as just a few examples. The tissue engineering device  102  may include multiple sensors such as infrared (IR) or other type of proximity sensor as well as accelerometers, gyroscopes, and/or GPS units to detect motion as an indicator of use. The tissue engineering device  102  is exemplary of multiple such devices that may be included in the exemplary treatment and monitoring system architecture  100  (i.e., just one is illustrated for simplicity of discussion). In other words, the server  108  may maintain a database of multiple tissue engineering devices  102  associated with multiple patients. 
     The tissue engineering device  102  may be in communication with a UE  104 . There may be a plurality of UEs  104  in the treatment and monitoring system architecture  100 , where some subset of UEs  104  may at least periodically come within communication range of one or more tissue engineering devices  102  and communicate with them according to embodiments of the present disclosure. The UE  104  may also be referred to as a terminal, a mobile station, a subscriber unit, etc. The UE  104  may be a cellular phone, a smartphone, a personal digital assistant, a wireless modem, a laptop computer, a tablet computer, a drone, an entertainment device, a hub, a gateway, an appliance, a wearable, peer-to-peer and device-to-device components/devices (including fixed, stationary, and mobile), Internet of Things (IoT) components/devices, and Internet of Everything (IoE) components/devices, etc. 
     According to embodiments of the present disclosure, the UE  104  may periodically pair with one or more tissue engineering devices  102  to receive treatment data (also referred to as sensor data, usage data, or monitored data herein) from the tissue engineering devices  102  and/or provide treatment regimen updates from the server  108  when those are received. With the data, the UE  104  may, when associated with the patient receiving treatment from the tissue engineering device  102  or someone in association with the patient, provide various interactive features to assist in promoting treatment according to the prescribed regimen. This may include calendar functions and associated reminders, smart calendaring (e.g., modifying reminders based on data obtained about actual treatment already performed), psychological encouragement such as with games or other motivational factors promoting the patient to engage in the prescribed treatment regimen, resource provision (e.g., contact information for one or more of sales representatives, manufacturer representatives, treating physician, etc.), and displays identifying remaining treatment time for a given application according to the treatment regimen, just to name some examples. 
     The wireless network  106  is one example of a network to which aspects of the present disclosure apply. The wireless network  106  may include one or more base stations that communicate with the UE  104 . A UE  104  may communicate with one or more base stations in the wireless network  106  via an uplink and a downlink. The downlink (or forward link) refers to the communication link from the base station to the UE  104 . The uplink (or reverse link) refers to the communication link from the UE  104  to the base station. The base stations in the wireless network  106  may also communicate with one another, directly or indirectly, over wired and/or wireless connections, as well as with the server  108  over wired and/or wireless connections. A base station in the wireless network  106  may also be referred to as an access point, base transceiver station, a node B, eNB, etc. 
     Although illustrated with the UE  104  acting as a relay to the tissue engineering device  102 , for example to conserve on energy at the tissue engineering device  102 , in some embodiments the tissue engineering device  102  may establish its own connection to the wireless network  106  to communicate with the server  108  without the assistance of the UE  104  (but may still establish a separate connection with the UE  104  according to aspects of the present disclosure).). Although illustrated as wireless, the wireless network  106  may also be, or include, wired connections (whether among different nodes, with the UE  104  and/or tissue engineering device  102 , etc.). 
     The server  108  may be a tissue engineering treatment regimen server that provides both a database to house current and historical usage/treatment data, treatment regimens, device profiles, patient profiles, physician profiles, manufacturer profiles, and/or sales representative profiles, as well as an additional intermediary between the tissue engineering devices  102 , UEs  104  that include modules/applications for patient and interested party interaction, manufacturer server  110  (if involved), and/or access devices  114 . The server  108  may update its database once it receives treatment data from tissue engineering devices  102  (whether via the UE  104  as a relay/intermediary or not), and use that data to generate compliance reports. This may be done by aggregating the data over time, e.g. on a daily basis or some other period of time, on demand, or forwarding in reports on a rolling basis in real time or near-real time. For example, the server  108  may analyze and characterize the data aggregated over time (e.g., both over a period of time and over multiple periods of time) to generate fields in the compliance report that identify likely amounts and types of activity sustained by the tissue engineering device  102  during the period (or periods) during the treatment regimen. The server  108  may communicate with the wireless network  106  via its own wireless connection and/or via one or more wired connections (e.g., backhaul connections, one or more wired network such as Internet connections, etc.) as well as with the server  110 /network  112  via one or more wired and/or wireless connections. 
     The server  110  may be a server hosted by the manufacturer of the tissue engineering device  102  (and/or provider of the module or application with which the patient interacts on the UE  104 , or by the physician on the access devices  114 ). For example, the server  110  may provide a portal for subscribing parties to access to review treatment regimens, modify those regimens (where permissions are given), update device profile parameters, etc. In some embodiments, the functions and purposes of the server  110  may be implemented together with the server  108 , or alternatively be not included. 
     One or more access devices  114  are in communication with the server  110  (and the server  108 ). In  FIG. 1 , these are illustrated as access devices  114 . a ,  114 . b , and  114 . c —this is representative of any number of access devices  114 . The access devices  114  are in communication with the server  110  via the network  112 , which may be any wired, wireless, or combination thereof network. As noted above, the access devices  114  may be associated with parties that have subscribed to access to the server  110  and the server  108 . The access devices  114  may include UEs such as discussed above, tablet computers, laptop computers, desktop computers, servers, etc. that provide access to subscribing parties. The access may include receiving compliance reports, sending messages back to the UE  104  and/or tissue engineering devices  102 , and/or sending treatment modifications to the server  110  and/or server  108  and on to the tissue engineering devices  102 . Further, the UE  104  may be one of many access devices  114 , in addition to those associated with other parties as well. 
     For example, a physician providing the treatment regimen for a patient using a tissue engineering device  102  may subscribe at a portal provided by the server  110  (or the server  108 ) to receive compliance reports from the server  108  as they are provided, select the frequency of those compliance reports, input new treatment regimens for already-registered or newly-added tissue engineering devices  102 , and/or modify existing treatment regimens (e.g., depending upon access privileges for the given subscriber). As another example, a relative of the patient may be allowed to subscribe for compliance reports, or some redacted version of the compliance reports, so as to provide additional incentive to the patient or their loved ones to support compliance with the treatment regimen. 
     As another example, as a patient uses (or doesn&#39;t use) the tissue engineering device  102  as prescribed, sensors that are part of the tissue engineering device  102  output monitoring results (e.g., ranging from actual measurements for interpretation by a processor to a binary output, such as yes/no for whether the feature the sensor is designed for was triggered or not during a given time period). The tissue engineering device  102  may further display a general treatment compliance to a treatment regimen (e.g., expressed as a percentage). If a UE  104  is already paired with the tissue engineering device  102 , then the data may be transmitted as soon as it is output (e.g., real-time, while in other examples the data may be transmitted according to a schedule such as to conserve battery power). Likewise, if the tissue engineering device  102  is in communication with the server  108  without the aid of the UE  104 , then the data may be transmitted as soon as it is output. Alternatively, where a UE  104  is not paired with the tissue engineering device  102  as data regarding compliance is output from the sensors, and the tissue engineering device  102  does not bypass the UE  104  in communicating with the server  108 , then the tissue engineering device  102  may store the data locally as it is output. 
     The storage may continue until it is periodically within range with a UE  104  that can pair with the tissue engineering device  102  to receive the data (and/or a scheduled time to transmit the data to the UE  104  or the server  108 ). In some embodiments, the UE  104  may be the patient&#39;s UE, and therefore may frequently be in proximity with the tissue engineering device  102  (and, when not, an alert on the UE  104  can remind the patient to bring them within range to pair and share data). As another example, a sales representative or other representative of the manufacturer, physician&#39;s office, or other entity may periodically visit different patients (or the patients visit them) and reach a sufficient proximity to intentionally pair with the tissue engineering devices  102  with which the UE  104  of the representative comes in range. However the data is retrieved/received from the tissue engineering device  102 , once it is compiled into a report the physician and other subscribed users may receive it and provide additional instruction/comments thereto for the benefit of the patient. 
     The storing of the sensor data until pairing occurs may also occur in embodiments where a transceiver capable of pairing with a UE  104  is located external to the tissue engineering device  102  (e.g., a power supply or a docking station). The tissue engineering device  102  may store the data locally until connected again to such an external transceiver, at which time data may continue being stored until paired, via the external transceiver, to a UE  104  as discussed above and further below. 
     At the UE  104 , the data received may be further analyzed to discover broader trends for the patient. For example, the UE  104  may determine using one or more embedded algorithms whether the patient is sedentary or mobile during each treatment session (based on the data from the tissue engineering device  102 ). This may be aggregated over time and analyzed by the UE  104  to determine further whether the patient is generally more or less mobile over a period of time (such as days, weeks, or months). These trends may be further passed on, such as part of the monitoring data, to the server  108 . At the server  108 , in addition to generating compliance reports generally, the server  108  may further analyze the monitoring data it receives to compare the patient&#39;s results to the results of similar patients&#39; data. That similar data may be made available through other sources, such as public registers and/or other patient recorded outcomes. 
       FIG. 2  is an organizational diagram of an exemplary tissue engineering device  102  as introduced in  FIG. 1 , according to aspects of the present disclosure. In the example of  FIG. 2 , the tissue engineering device  102  may be a PEMF device having one of many configurations within the treatment and monitoring system architecture  100  of  FIG. 1  (in embodiments where the tissue engineering device  102  is an ultrasound device, the coil  208  may be replaced with an ultrasound transducer; the description here is of the PEMF device for  FIG. 2  and other figures for simplicity of discussion). The tissue engineering device  102  may include a processor  202 , a memory  204 , a coil  208 , sensors  210 . a  through  210 . n , a transceiver  212  (including a modem  214  and RF unit  216 ), and an antenna  218 . These elements may be in direct or indirect communication with each other, for example via one or more buses. 
     The processor  202  may have various features as a specific-type processor. For example, these may include a central processing unit (CPU), a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a controller, a field programmable gate array (FPGA) device, another hardware device, a firmware device, or any combination thereof configured to perform the operations described herein with reference to the tissue engineering devices  102  introduced in  FIG. 1  above. The processor  202  may also be implemented as a combination of computing devices, e.g., a combination of a controller and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. 
     The memory  204  may include a cache memory (e.g., a cache memory of the processor  302 ), random access memory (RAM), magnetoresistive RAM (MRAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read only memory (EPROM), electrically erasable programmable read only memory (EEPROM), flash memory, solid state memory device, hard disk drives, other forms of volatile and non-volatile memory, or a combination of different types of memory. In some embodiments, the memory  204  may include a non-transitory computer-readable medium. The memory  204  may store instructions  206 . The instructions  206  may include instructions that, when executed by the processor  202 , cause the processor  202  to perform operations described herein with reference to a tissue engineering device  102  in connection with embodiments of the present disclosure. The terms “instructions” and “code” may include any type of computer-readable statement(s). For example, the terms “instructions” and “code” may refer to one or more programs, routines, sub-routines, functions, procedures, etc. “Instructions” and “code” may include a single computer-readable statement or many computer-readable statements. 
     The coil  208  provides PEMF pulses according to embodiments of the present disclosure. Control electronics for the coil  208  may be included as part of the processor  202  (e.g., in combination with instructions  206  in the memory  204 ) or alternatively be separate hardware. The coil  208  may be constructed with multiple windings of any suitable material for generating electromagnetic fields according to the treatment regimen as provided by the processor  202 . For example, the processor  202  may access the treatment regimen stored in the memory  204  that causes current to pass through the coil  208 , including according to a set rise and/or fall time, duty cycle, amplitude, frequency, etc. for the current so as to generate electromagnetic frequency pulses of a desired duration, size, shape, and frequency. Further, the treatment regimen may be modified via one or more updates received from the server  108 , whether via the UE  104  or other network components/connections. 
     The treatment regimen may include programmed pulse trains, where each pulse train includes a specified number of pulses with specified duration (and rise/fall times with specified amplitude), and repeated in a fixed pattern over time (i.e., duty cycle) over the course of a given treatment period. There may be a number of treatment periods specified over a longer duration of time. For example, a given treatment period may be specified to last for several hours each day—the treatment period may refer to the two hour duration specified per day, which may be repeated for a longer duration such as over weeks or months. A heartbeat LED may indicate a treatment status for the periodic application of the PEMF over the long-term duration. 
     Multiple sensors  210 . a  through  210 . n  represent any number of sensors that may monitor different aspects of operation of the tissue engineering device  102  according to embodiments of the present disclosure. For example, sensor  210 . a  may be an accelerometer. As the tissue engineering device  102  is placed on the patient, the accelerometer may sense this motion and output, e.g. when polled, periodic status indicators identifying whether motion has been detected. 
     For example, every 100 ms the accelerometer may be polled by the processor  202  to determine whether motion is detected; if so, the data output may be a yes (e.g., a first binary value) and if not then a no (e.g., a second binary value). Over multiple such intervals, e.g. after 3 seconds, if motion is detected with any poll of the accelerometer, then this is identified as “yes” for the 3 second chunk of time. After multiple 3 second chunks of time, e.g. after 30 seconds, if more than half of the 3 second chunks of time are identified as “yes,” then the 30 second chunk of time is identified as “yes.” After multiple 30 second chunks of time, e.g. after 5 minutes, if more than a quarter of the 30 second chunks are identified as “yes,” then the 5 minute chunk is identified as “yes.” This may again occur with a longer chunk of time, e.g. 30 minutes. These particular values for time are exemplary only; other values may be used instead. Further, the thresholds (e.g., half or a quarter) may also be changed based on the parameters of a particular system to be larger or smaller than that given in this example. 
     As another example, sensor  210 . n  may be an infrared sensor. The infrared sensor may be used to detect whether something is within a threshold proximity of the sensor. Therefore, the infrared sensor may be placed (one or more) in a location of the tissue engineering device  102  intended to face the body of the patient receiving treatment. As another example of a sensor similar in intent to an infrared sensor, the tissue engineering device may include a capacitive sensor instead of or in addition to the infrared sensor. 
     Using the infrared sensor as an example, the infrared sensor may operate in cooperation with the accelerometer to assist in identifying whether the tissue engineering device  102  is being used in accordance with the treatment regimen. For example, the processor  202  may periodically poll the infrared device to determine whether it is detecting proximity to another object (e.g., some part of the patient). If not, then it may be concluded that even if motion is detected by the accelerometer, the tissue engineering device  102  is not being used for treatment. In contrast, if the infrared sensor indicates close proximity to an object, but the accelerometer does not detect motion above a threshold amount, then it may be inferred that the tissue engineering device  102  is not being used for treatment. This may occur, for example, where the tissue engineering device  102  is placed on some vibrating object such as a laundry machine. 
     As another example of a sensor, the tissue engineering device  102  may include a global positioning system (GPS) device. The GPS device may detect the location of the tissue engineering device  102  and provide that to the processor  202  for further analysis. For example, the location of the patient&#39;s preferred place of treatment may be stored and compared against whenever the coil  208  is activated. If the GPS device detects a location outside a threshold radius of the preferred place, then it may be inferred that treatment is not occurring (unless the patient expressly inputs that treatment is occurring). As another example, if the GPS device detects that the tissue engineering device  102  is moving, but the IR sensor (where included) detects that the tissue engineering device  102  is not in sufficient proximity to another object (e.g., the patient) then it is inferred that treatment is not occurring. 
     As another example of a sensor, the tissue engineering device  102  may include an impedance monitor sensor (also referred to as simply an impedance monitor). The impedance monitor may use impedance spectroscopy to identify different types of tissue of the patient and correlate that to the known types of tissues present in the different stages of healing. This data may be included to assist in monitoring the progress of healing, which may be correlated to the level of compliance that the patient has over time with the tissue engineering device  102 . The impedance monitor may be an ultrasound or electromagnetic field. 
     As an alternative to the impedance monitor sensor, more generally the impedance monitor sensor may be a type of sensor to monitor healing. This may include an impedance monitor sensor as noted above. Alternatively, it may include a sensor such as x-rays (e.g., low-energy x-rays), ultrasound, electrical impedance tomography, or other approaches to measure healing or density such as measuring electrical and/or electroacoustic properties of healing tissue, etc. (e.g., some combination of the above sensor types). All of these approaches may be referred to herein generically under “impedance monitoring” and “impedance monitoring sensors” for purposes of simplicity of discussion. 
     These are a few examples of sensors  210 . a  through  210 . n  that may be included with the tissue engineering device  102 , and which may be used to output data (historical and/or current) that assists in determining an amount of progress for a current application period as well as multiple application periods over time. Any combination of the sensors may be included in a given tissue engineering device  102 , or all of them in cooperation with each other. 
     As shown, the transceiver  212  may include the modem subsystem  214  and the radio frequency (RF) unit  216 . The transceiver  212  can be configured to communicate bi-directionally with other devices, such as UEs  104  and/or other network elements such as those in the wireless network  106 . The modem subsystem  214  may be configured to modulate and/or encode data according to any of a variety of coding schemes. The RF unit  216  may be configured to process (e.g., perform analog to digital conversion or digital to analog conversion, etc.) modulated/encoded data from the modem subsystem  214  (on outbound transmissions) or of transmissions originating from another source such as a UE  104 . Although shown as integrated together in transceiver  212 , the modem subsystem  214  and the RF unit  216  may be separate devices that are coupled together to enable the tissue engineering device  102  to communicate with other devices. 
     The RF unit  216  may provide the modulated and/or processed data, e.g. data packets (or, more generally, data messages that may contain one or more data packets and other information), to the antenna  218  for transmission to one or more other devices such as the UE  104 . This may include, for example, transmission of sensor data (either raw or processed, such as “yes” or “no” data over time) according to embodiments of the present disclosure. The antenna  218  may further receive data messages transmitted from other devices and provide the received data messages for processing and/or demodulation at the transceiver  212 . Although  FIG. 2  illustrates antenna  218  as a single antenna, antenna  218  may include multiple antennas of similar or different designs in order to sustain multiple transmission links. 
     In some embodiments the transceiver  212  may be a Bluetooth low energy (BLE) device. In other embodiments, the transceiver  212  may be a USB port, an Ethernet port, a cell module (e.g., LTE, 5G, etc.), a WiFi module, a ZigBee module, or a near field communication (NFC) module. The tissue engineering device  102  may further include multiple transceivers  212 , such as a BLE device as well as a cell module to provide multiple forms of communication. In embodiments where multiple forms of communication are possible, the tissue engineering device  102  may communicate with different devices concurrently. For example, the tissue engineering device  102  may pair with a first UE  104  via a first connection, such as BLE, and also pair with a second UE  104  via a second connection such as NFC. Further or alternatively, the tissue engineering device  102  may communicate with the network  106  via a cell module (where included) concurrent to pairing with one or more UEs  104 . 
     As another example, the transceiver  212  (or multiple transceivers  212 ) may be coupled with the tissue engineering device  102  via one or more connections. For example, the transceiver  212  may be included with some accessory to the tissue engineering device  102 , such as a charging power supply or a docking station for the tissue engineering device  102 . The tissue engineering device  102  may couple with the accessory via a cable or other connection, such as a USB cable. Thus, in embodiments where the transceiver  212  is included with an accessory, the sensor data may be kept by the tissue engineering device  102  (e.g., in the memory  204 ) until the tissue engineering device  102  is connected with the accessory, which may occur during a treatment or in between treatments, or both. Upon connection, the transceiver  212  may transfer sensor data to the paired UE  104 /network  106  according to the type of transceiver included. When included in an accessory, the size and battery consumption of the tissue engineering device may be further minimized. 
     Turning now to  FIG. 3 , an organizational diagram  300  of an exemplary user device (UE)  104  (e.g. as introduced in  FIG. 1 ) is illustrated according to aspects of the present disclosure. The UE  104  may be any of a variety of devices as discussed above with respect to  FIG. 1 . The UE  104  may include a processor  302 , a memory  304 , a compliance module  308 , transceivers  310 . a  and  310 . b , and antennae  316 . a  and  316 . b . These elements may be in direct or indirect communication with each other, for example via one or more buses. 
     The processor  302  may have various features. For example, these may include a central processing unit (CPU), a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a controller, a field programmable gate array (FPGA) device, another hardware device, a firmware device, or any combination thereof configured to perform the operations described herein with reference to the UEs  104  introduced in  FIG. 1  above. The processor  302  may also be implemented as a combination of computing devices, e.g., a combination of a controller and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. 
     The memory  304  may include a cache memory (e.g., a cache memory of the processor  302 ), RAM, MRAM, ROM, PROM, EPROM, EEPROM, flash memory, solid state memory device, hard disk drives, other forms of volatile and non-volatile memory, or a combination of different types of memory. In some embodiments, the memory  304  may include a non-transitory computer-readable medium. The memory  304  may store instructions  306 . The instructions  306  may include instructions that, when executed by the processor  302 , cause the processor  302  to perform operations described herein with reference to a UE  104  in connection with embodiments of the present disclosure. 
     The compliance module  308  may be an application executed by the processor  302 , for example an application downloaded from the server  108  (or the server  110  as some examples). The compliance module  308  may include multiple features designed to both monitor the use of the tissue engineering device  102  as well as encourage compliance with a prescribed treatment regimen. For example, the compliance module  308  may store treatment regimens/updates to treatment regimens that are meant for a tissue engineering device  102  with which the UE  104  is paired (or has been paired with in the past). Further, the compliance module  308  may store other data associated with the patient&#39;s return to health. For example, the compliance module  308  may periodically prompt the user to provide pain scale data (i.e., a rating by the using of what level of pain (if any) the user is feeling). This may be captured on a visual pain scale, a graduated numeric scale, etc. as just some examples. Other patient health information related to progression of healing or therapy may include recording daily activity levels, adherence to physical therapy protocols or taking prescribed medications, some combination of the above, etc. The compliance module  308  may cause a transceiver  310  to transmit this information (all or some of it) to the paired tissue engineering device  102  at the next (or a timed) opportunity. 
     For example, the transceiver  310 . a  (including modem  312 . a  and RF unit  314 . a , coupled to antenna  316 . a ) may be a Bluetooth (or Bluetooth LE) device configured to pair with other BLE devices, such as when the transceiver  212  associated with tissue engineering device  102  is another BLE device. The transceiver  310 . a  may alternatively be, or additionally include, a USB port, an Ethernet port, a cell module (e.g., LTE, 5G, etc.), a WiFi module, a ZigBee module, or a near field communication (NFC) module. The UE  104  may further include a transceiver  310 . b , including modem  312 . b  and RF unit  314 . b  with similar functions as discussed above with respect to transceiver  212  of  FIG. 2 . Transceiver  310 . b  may be configured to communicate with the network  106  and the server  108 , as discussed with respect to  FIG. 1  regarding the UE  104 . Although illustrated as separate transceivers  310 . a  and  310 . b , these may be a single transceiver  310  that may communicate using a single communication protocol/hardware (e.g., BLE or NFC), or multiple protocols/hardware (e.g., LTE, 5G, BLE, NFC, etc.). 
     The UE  104  may receive monitored data via the transceiver  310 . a  (and in embodiments data entered by the user via the UE  104 ) and forward the data, or some subset thereof (e.g., stripped of patient information and/or encrypted where the tissue engineering device  102  did not do so) to the server  108  for back-end storage, data analysis, and/or access by one or more subscribing access devices  114 . 
     Turning again to the compliance module  308 , other examples of features include a calendar. The calendar may both maintain the treatment regimen prescribed by the treating physician, but also provide an interface to the patient using the tissue engineering device  102  that identifies various treatment details. For example, each day may be illustrated with an icon, showing for example a timeframe (e.g., a week, a month, etc.) with each day identifying whether treatment was compliant or not (e.g., a green dot for the day where compliant, red for non-compliant, and some shade scale of colors for partial compliance that is understandable with a legend). The calendar may also summarize treatment details, such as identifying a number of days compliant treatment has occurred, identifying how many days are left over the period of time for the course of the treatment, etc. 
     The calendar may further be used to organize pain scale and other information. Looking at pain scale data in particular, this may refer to a quantifiable pain scale that scales the amount of pain a user (of the tissue engineering device  102  as well as of the associated account profile that is accessible by the UE  104 ) is then feeling, whether in that moment or aggregated since the last periodic check. The scale may range, for example, between two numeric ends, such as zero and ten (or some other numbers, since this is exemplary only), with one end, such as zero, corresponding to no pain felt, to  10 , a worst possible pain, with values in between scaling between the two. The interface may provide discrete value selections, e.g. via radio buttons or some other similar interface, while in other embodiments the interface may constitute a sliding scale that the user may manipulate via finger, mouse, or other input. The periodicity of the pain scale collection may be on a daily basis, or that otherwise coincides with the periodicity of the treatment itself (e.g., daily, every other day, etc.). Thus, with reference to the calendar described above with respect to the compliance module  308 , the compliance module  308  may associate, and store, the collected pain scale information with the day on which the pain scale data was collected. 
     In addition to collecting pain scale information, the compliance module  308  may cause the UE  104  to collect images of the treatment of the patient (user). This may also be done on a periodic basis. This periodic basis may be the same as the periodic basis of the pain scale information prompts (that prompt the user to input the information). In such embodiments, after collecting the pain scale information the compliance module  308  may prompt (e.g., via an interface of the UE  104 , or which may be sent to the tissue engineering device  102  as a prompt to an interface of that device to collect the response) to collect an image of the treatment site on the patient. In other embodiments, the compliance module  308  may prompt the user of the UE  104  to collect an image of the treatment site in response to the collected pain scale information exceeded a threshold. In that case, the compliance module  308  compares the pain scale information after it is collected to the threshold and determines whether to prompt the user to collect the image based on the result. When collected, the images may also be associated as the pain scale information with the calendar, and the compliance module  308  may store the collected image with the pain scale information under the day on which the pain scale data was collected. 
     The compliance module  308  may further collect information regarding activity level of the patient (i.e., the user of the UE  104 ). For example, the activity level may identify activities of daily living (or some other increment of time) as input from the patient. This may assume the form of a narrative that is sent with compliance information (e.g., as part of the compliance report discussed herein) that is coded by someone with access to the database in the server  108 . As another example, this may assume the form of a pre-set field of possible options (e.g., a list of pre-selected activities of interest to the physician or the manufacturer of the tissue engineering device  102 , or a list that may dynamically grow based on the user&#39;s selection of activities), with each selection providing some numeric value to assist in quantifying the activity level of the patient. 
     For example, for certain activities such as sports or jobs with specific physical activity requirements, activity above a threshold level (e.g., as quantified according to the concept described herein) may raise a flag that triggers notification of the physician that prescribed the treatment regimen. This may be, at least in part, because an increase in particular activity levels may be an indicator of future pain scale information increases. In response, the physician may review the activity, seek further information from the patient, send a message to the patient regarding risks of the activity, flag for subsequent scrutiny (e.g., because pain may increase later due at least in part to the activity), or take no action. In addition or alternatively, the compliance module  308  may collect information regarding compliance in taking one or more prescribed medications associated with the treatment regimen. 
     As another example of another feature for the module, the compliance module  308  may, during a particular periodic treatment, provide a status indicator that identifies how much time is remaining for the current treatment as the patient desires it. The compliance module  308  may further provide reminders to the patient via multiple alert approaches, including audible alerts, text alerts, email alerts, and visual alerts. For example, where the UE  104  is the patient&#39;s smartphone and the compliance module  308  is provided from an application downloaded from the server  108 , then the alerts may be an alarm set to a particular time of day that the patient selected as the desired time to start treatment for that day per the regimen. The alarm may be audible and/or visual, as well as include a text or other notification that draws attention. 
     The compliance module  308  may dynamically modify the intensity of the alert (whether in terms of frequency of the alert, noticeability of the alert, or some combination thereof). This may be modified based on treatment data received from the tissue engineering device  102  over time. Thus, for example, where the patient is compliant with treatment over time, the reminders may be minimized to a system tray reminder without audible and/or other visual alerts. If, however, the compliance is below a threshold, the alerts may become more aggressive, with audible alerts, changing volume (e.g., higher volume as percent compliant goes down over time), intrusive visual displays (e.g., to disrupt text reading such as text reminders, interactive text-based messages, etc.), as well as potentially short audible reminders during phone use. The intensity of the reminders may increase as the level of compliance is determined to be decreasing over time, so as to encourage patient compliance with a treatment regimen designed for patient efficacy. In addition, an escalation hierarchy may be applied where, if the alerts are ignored by the patient/user of the UE  104  (e.g., by the compliance metric not changing, or not improving sufficiently, or the alerts are not acknowledged as being received, etc.), then the alerts may be escalated to additional parties. For example, escalation may be to a sales representative for the tissue engineering device  102  (and/or back-end services at the server  108 ), a customer service representative, a prescribing physician, a family member, and/or a health insurance provider (in an order of preference of escalation set either by the manufacturer, the prescribing physician, and/or the user/patient). 
     Further, where the treatment has already occurred for a given period of the treatment regimen, the compliance module  308  may dynamically reduce the reminders in either frequency or intensity, or both. For example, where on a given day the patient completes the treatment prior to a time for which reminders are scheduled, the compliance module  308  may cancel the reminder for that day. If, however, the time of day that the treatment occurs is important, the compliance module  308  may allow the alert to be, instead of a typical alert to treatment, a reminder that the time of day of treatment is important (where applicable) to the treatment in addition to the periodicity and duration. Where treatment is partially completed for the day when the reminder is scheduled, the reminder may be modified in its content and/or intensity to account for the amount of treatment already determined to be completed (e.g., from data already received from a paired tissue engineering device  102 ). 
     In addition to, or as an alternative to, the dynamic alerts, the compliance module  308  may modify alert preferences based on the patient interacting with settings of the compliance module  308 , e.g. to activate the dynamic alerts, to set a static frequency/intensity of alerts over time, and/or further modify the alerts (whether dynamic or static) according to their preference and/or individual schedule. Further, the compliance module  308  may alert the patient audibly and/or visually when the treatment for the day is completed. 
     The compliance module  308  may further include an interface that the user of the UE  104  may use to trigger the UE  104  (via transceiver  310 . a  for example) to search for other tissue engineering devices  102  with which to pair. This may be applicable, for example, where a representative of either the manufacturer or the prescribing physician, etc. periodically seeks to visit the patient and obtain data from the tissue engineering device  102  during that visit (a so-called milk run). Thus, the compliance module  308  allows the UE  104  to pair with multiple tissue engineering devices  102 , whether in sequence or in parallel. 
     The compliance module  308  may further include, such as in a management mode, useful information for the patient including an identified time/time of day prescribed for the PEMF treatment, a difference between the current time and the next prescribed treatment time, contact information for the prescribing physician and/or representative for the provider of the tissue engineering device  102 , etc. Further, one or more links to online access systems, repositories, etc. may be provided. For example, a link may be provided to an online account system hosted by the server  110  of the manufacturer (or by the server  108 ) where the patient can update certain profile information. The compliance module  308  may further provide links to other patient treatment services as offered by the manufacturer and/or prescribing physician. 
     The compliance module  308  may direct the transceiver(s)  310  in receiving messages from one or more interested parties (e.g., prescribing physician, manufacturer, advertiser where patient has indicated willingness to accept such, etc.), displaying the messages locally via a display of the UE  104 , and/or conveying the messages on to the tissue engineering device  102  with which the messages are associated. When in management mode, the interface may be further used (e.g., where the UE  104  is associated with a representative of the manufacturer or the physician) to modify one or more compliance thresholds used to trigger one or more alerts for the paired tissue engineering device(s)  102 . 
     In some embodiments, the compliance module  308  causes the transceiver  310 . b  to transmit (either periodically or as they are received) the data (or some subset) from the tissue engineering device  102  (and/or from the user interface of the UE  104 , such as pain scale information and/or treatment site images) to the server  108  for back-end storage, data analysis, and/or access by one or more subscribing access devices  114 . The compliance module  308  may cause the data to be transmitted without further processing or by stripping additional identifying data (e.g., the data may be transmitted only with the device serial number of the associated tissue engineering device  102 ) and/or encrypting. Alternatively, the compliance module  308  may generate the compliance report (or some portion thereof) before transmitting to the server  108  (in which case the results may be displayed on the UE  104 , for example). Moreover, in some examples the compliance report (or some portion thereof) may be generated by the tissue engineering device  102 , transmitted to the UE  104  for display, and/or further transmitted to the server  108  (with stripping of relevant identifying data and/or encrypting as noted above) in similar manner. The compliance report, whether generated by the UE  104  or the server  108  (or the tissue engineering device  102 ), may include such things as a number of days that the patient has been compliant in using a tissue engineering device  102  according to a prescribed treatment regimen over time (whether since the last data was received or since some previous time point, such as the start of treatment). 
     The compliance report may further include a breakdown of the use of the tissue engineering device  102  on per-time frame basis (e.g., per day) to assist in identifying any trends of use (e.g., compliance dips during weekends, etc.). The compliance report may also include a percentage that identifies a total level of compliance to the prescribed treatment regimen—either a single percentage over the full duration, or on a more granular basis such as per week, per day, etc. Thus, compliance may be reported overall as well as for, or just for, each treatment day (e.g., depending on user or prescribing physician preference to name a few examples). As another example, the compliance report may include pain scale information collected from the user and stored per calendar collection times, and/or images of the treatment site. Thus, in embodiments of the present disclosure, tissue engineering device  102  use compliance, pain scale information associated with the use, and treatment site images may all be collected and available for use by physicians and other authorized representatives, e.g. either daily or some other periodic (i.e., aggregated or snapshot) basis. The compliance module  308 , as part of generating the compliance report, may further analyze and characterize the data aggregated over time to identify likely amounts and types of activity sustained by the tissue engineering device  102  during the treatment regimen, and include this information in the compliance report. 
     The compliance report may further include information associated with patient recovery from compliance, including for example the pain scale data, activity levels according to a periodic metric, adherence to physical therapy protocols (e.g., including the tissue engineering device use, and/or other physical therapy protocols including exercises), and/or adherence to taking prescribed medications, to name just a few additional examples. Further, the compliance module  308  may include in the compliance report (or transmitted as part of the monitoring data to the server  108  for inclusion in a report there) additional analysis done on the monitoring data, including a determination using one or more embedded algorithms whether the patient is sedentary or mobile during each treatment session (based on the data from the tissue engineering device  102 ). This may be aggregated over time and analyzed by the UE  104  to determine further whether the patient is generally more or less mobile over a period of time (such as days, weeks, or months). 
     Where the compliance report is generated at the UE  104 , e.g. by the compliance module  308  (such as via the processor  302 ), the UE  104  may strip the compliance report of patient information such as name, birthday, etc. prior to transmission to the server  108  so as to be compliant with any patient privacy laws in place (and/or by encrypting). A device identifier may still be included, which the server  108  may use to locate the patient assigned that device in a database. 
     Turning now to  FIG. 4 , an organizational diagram  400  of an exemplary server apparatus (e.g., server  108 ) is illustrated according to aspects of the present disclosure. The server  108  may include a processor  402 , a memory  404 , a database  408 , a compliance module  410 , transceiver  412 , and antennae  418 . These elements may be in direct or indirect communication with each other, for example via one or more buses. 
     The processor  402  may have various features. For example, these may include a central processing unit (CPU), a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a controller, a field programmable gate array (FPGA) device, another hardware device, a firmware device, or any combination thereof configured to perform the operations described herein with reference to the server  108  introduced in  FIG. 1  above. The processor  402  may also be implemented as a combination of computing devices, e.g., a combination of a controller and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. For example, the processor  402  may be implemented as a plurality of processing cores. 
     The memory  404  may include a cache memory (e.g., a cache memory of the processor  302 ), RAM, MRAM, ROM, PROM, EPROM, EEPROM, flash memory, solid state memory device, hard disk drives, other forms of volatile and non-volatile memory, or a combination of different types of memory. In some embodiments, the memory  404  may include a non-transitory computer-readable medium. The memory  404  may store instructions  406 . The instructions  406  may include instructions that, when executed by the processor  402 , cause the processor  402  to perform operations described herein with reference to a server  108  in connection with embodiments of the present disclosure. 
     The server  108  includes the database  408  which stores data associated with a plurality of device profiles. Each device profile may be associated with a different tissue engineering device  102 . Alternatively, each profile may be associated with a different physician, and therefore have multiple devices associated therewith, as just two examples. Each tissue engineering device  102  may be associated, in the database, with patients to which the devices have been prescribed. This association may be made by a representative, e.g. via the server  110 , of either the manufacturer or the prescribing physician. The database  408  may further house treatment regimens, device profiles, patient profiles, physician profiles, manufacturer profiles, and/or sales representative profiles. 
     The database  408  may, upon receipt of treatment data from a UE  104  (or tissue engineering device  102  without relay by a UE  104 ) store the data into appropriate locations and associate the data in the database  408  with the appropriate profile(s). This data may include, as noted above, both information regarding compliance (such as number of days in compliant use, level of compliance per treatment) as well as pain scale and/or treatment site image data. The compliance module  410  may be used to manage the database  408 , or alternatively another source of interaction. As treatment data is received, the compliance module  410  may cause the database  408  to be updated and the update acknowledged. 
     Over time, the compliance module  410  may aggregate the data received from one or more reporting tissue engineering devices  102  (whether collected periodically according to a schedule, in real time, or on demand to name some examples) and use this aggregated data to generate compliance reports, similar to as discussed above with respect to the compliance module  308  when generating compliance reports. The data forming the basis of the compliance reports may be obtained from the database  408  and/or from data as it is received from UEs  104 /tissue engineering devices  102 . Further, where the UE  104  generates compliance reports itself (via compliance module  308 ), these UE-generated compliance reports may be stored in the database  408  as well, and these UE-generated compliance reports may form the basis of longer-term trend compliance reports by the compliance module  410  of the server  108 . The compliance module  410  may further analyze the monitoring data it receives to compare the patient&#39;s results to the results of similar patients&#39; data. That similar data may be made available through other sources, such as public registers and/or other patient recorded outcomes. 
     The compliance module  410  may also generate the application that is downloaded by UEs  104  and becomes the compliance module  308  described above with respect to  FIG. 3  when installed. Further, the compliance module  410  may cause the database  408  to store any messages received from a subscribing entity via an access device  114  (e.g., a representative of a physician) and the transceiver  412  to forward the message to the targeted tissue engineering device  102  (and/or paired UE  104 ). 
     As shown, the transceiver  412  may include the modem subsystem  414  and the radio frequency (RF) unit  416 . The transceiver  212  can be configured to communicate bi-directionally with other devices, such as UEs  104  and/or other network elements such as those in the wireless network  106 . The modem subsystem  414  may be configured to modulate and/or encode data according to any of a variety of coding schemes. The RF unit  416  may be configured to process (e.g., perform analog to digital conversion or digital to analog conversion, etc.) modulated/encoded data from the modem subsystem  414  (on outbound transmissions) or of transmissions originating from another source. Although shown as integrated together in transceiver  412 , the modem subsystem  414  and the RF unit  416  may be separate devices that are coupled together to enable the server  108  to communicate with other devices. Although  FIG. 4  illustrates antenna  418  as a single antenna, antenna  418  may include multiple antennas of similar or different designs in order to sustain multiple transmission links. 
     These different devices cooperate to provide an exemplary treatment and monitoring system.  FIG. 5  is a protocol diagram  500  illustrating exemplary aspects between treatment and monitoring system elements according to aspects of the present disclosure. As illustrated, the protocol diagram  500  shows exemplary interactions between a tissue engineering device  102  (exemplary of potentially multiple such devices), a UE  104  (exemplary of potentially multiple), server  108  (exemplary of potentially multiple), server  110  (exemplary of potentially multiple), and an access device  114  (exemplary of potentially multiple). 
     At action  502 , a UE  104  pairs with a tissue engineering device  102 . This may occur, for example, via BLE or NFC connections as just some examples. This may occur periodically as the devices come within range of each other. Further, where the devices remain in range with each other outside of necessary times of communication (e.g., no treatment is scheduled at a particular time where the devices are in sufficient proximity to each other, etc.), the devices may only pair at action  502  as determined necessary so as to conserve energy (though the devices may alternatively remained paired so long as they are in proximity to each other). 
     At action  504 , the tissue engineering device  102  detects treatment data. This may include sensor data from the one or more sensors (such as patient proximity data, accelerometer data, gyroscope data, etc.). This may also or alternatively include detecting when treatment is not occurring though it should according to a prescribed treatment regime. Although illustrated as occurring after the pairing at action  502 , the data from action  504  may have been detected previously and stored until pairing occurred. 
     At action  506 , the tissue engineering device  102  transmits the treatment data to the UE  104 . In embodiments where the tissue engineering device  102  is capable of communicating with the server  108  without the relay assistance of a paired UE  104 , this may not occur. Further, where the transceiver is included with a power supply or otherwise, this may include transmitting the treatment data to the power supply, from which the treatment data will be transmitted once it is paired with a UE  104 . However transmitted, the tissue engineering device  102  may transmit the data with patient identifying information stripped from the data, so that only the data with a device identifier are included, and/or by encrypting the data. 
     At action  508 , the UE  104  receives the treatment data transmitted from the tissue engineering device  102  and forwards it to the server  108 , for example via one or more networks  106 . Where the tissue engineering device  102  failed to strip (and/or encrypt) sufficient data to ensure compliance with any patient privacy laws, then the UE  104  may further strip (and/or encrypt) the data before transmission to the server  108 . In some embodiments, the UE  104  may prompt the user of the UE  104  (e.g., via the compliance module  308 ) for pain scale information coincident with the treatment occurring with the tissue engineering device  102  (e.g., daily). In other embodiments, the UE  104  may prompt the user when it is paired with the tissue engineering device  102 , regardless of whether that is coincident in time with when treatment is occurring. In yet other embodiments, the UE  104  may prompt the user on a scheduled basis regardless of whether treatment has occurred on that day yet or not (e.g., daily). 
     Yet further, the UE  104  may occasionally or periodically prompt the user of the UE  104  (e.g., via the compliance module  308 ) to collect an image of the treatment site (such as via a camera integrated with, or paired with, the UE  104 ; alternatively, the image may be collected by any camera and associated with the user&#39;s profile at either the UE  104  or the server  108 ). The images may be collected at the same periodic rate at which the pain scale information is collected (e.g., daily) or only in response to the reported pain exceeding a threshold on the pain scale. This information is all described in association with action  508  of  FIG. 5  for simplicity of discussion, though it may be collected at times unrelated to the receipt of treatment data from action  506  (e.g., on a scheduled basis that may be consistent with the treatment regimen periodicity but independent of the actual time selected by the user for treatment on any given day). 
     At action  510 , the server  108  compiles a compliance report for the patient associated with the tissue engineering device  102  based on the most recently received data from action  508 . As part of this process, the server  108  may re-associate the data from the tissue engineering device  102  to the patient to which the device was prescribed, for example by looking up the device identifier of the tissue engineering device  102  included in the data with the records in the database  408  ( FIG. 4 ). 
     At action  512 , after the compliance report is generated (either by the server  108  or supplemented by the server  108  after generation at the UE  104  where applicable), the server  108  sends, or makes available, the compliance report to other entities. This may be in a periodic transmission, or rendering the compliance report available for access on demand by authorized parties. As illustrated, the server  108  sends the compliance report to the server  110  (e.g., that hosts an access portal for accessing parties such as a representative for the device manufacturer and the prescribing physician). The server  110  then may make the compliance report available to the appropriate parties. 
     For example, the server  110  may maintain different sets of permissions (although discussed with respect to server  110 , this may alternatively be maintained by the server  108  e.g. as part of the database  408 ) for different accessing parties. For example, a representative of the manufacturer may only have access to the compliance data (and/or pain management data) without identifying the patient, while the prescribing physician may have access to the identity of the patient as well. 
     The server  110 , at action  514 , sends the compliance report (or some subset thereof, depending upon permission level) to an access device  114 , such as that of a representative of a physician or a manufacturer of the tissue engineering device  102 . 
     At action  516 , the compliance report (whatever portion allowed) is presented via the access device  114  and any updates are processed at that time. For example, the pain treatment data may be accessed via the access device  114  (where presented/available) on a calendar basis, such as via a snapshot listing for multiple days in a row. If the reviewing entity determines that the pain scale information is noteworthy, the reviewing entity may select the day associated with that information and access one or more images of the treatment site associated with that same day (e.g., to look for redness or other signs of infection or other condition). As another example, the prescribing physician may desire to send a message to the patient (such as encouragement to increase compliance, to indicate a reminder for a follow-up appointment, to change the regimen, follow-up regarding pain information, etc.). 
     At action  518 , the access device  114  sends the message/update back to the server  110  (e.g., by entry into a field via a portal provided by the server  110 ). 
     The server  110 , in turn, at action  520  forwards the message/update to the server  108 . 
     At action  522 , the server  108  may store the message/update into the database  408 . For example, where the physician desires to change the treatment regimen, this may be stored in the appropriate database location associated with the patient and tissue engineering device  102 , so that future compliance reports may accurately reflect the most recent treatment regimen information. 
     At action  524 , the server  108  forwards the message/update to the UE  104  (where the UE  104  acts as a relay to the tissue engineering device  102  to which the message/update is intended). 
     At action  526 , the message/update may be displayed by the UE  104 . Thus, if it is an update that does not necessarily need to be displayed, the UE  104  may still display to notify the patient, and messages intended for the UE  104  to display may similarly be displayed. 
     At action  528 , any updates (e.g., to treatment regimen) are forwarded from the UE  104  to the tissue engineering device  102  (or from the server  108  to the tissue engineering device  102  where a UE  104  is not required/used for relaying data). 
     Action  530  may occur throughout the actions  504  through  528 . At action  530 , feedback for the current periodic application of the treatment is provided. This may include the treatment data transmitted at action  506 . Further, this may include providing treatment feedback dynamically to the user as treatment is occurring, either via a display on the tissue engineering device  102  and/or a display on the UE  104  paired or associated with the tissue engineering device  102 . 
     At action  532 , any reminders scheduled or provided by default, for example by the compliance module  308  of UE  104 , may be modified based on the feedback received at action  530 . Thus, a reminder for treatment may be modified (e.g., either in intensity such as sound or visual, or in content) to take into account a level of treatment already reached for the current periodic application according to the treatment regimen. 
     At action  534 , the reminder (and, if applicable, as modified from action  532 ) is displayed to the intended displays, whether a display of the UE  104 , a display of the tissue engineering device  102 , and/or any other devices to which a reminder is sent or scheduled. 
     This process may repeat over time as data is periodically reported from the tissue engineering device  102  for compliance monitoring and reporting, so that treatment by the tissue engineering device  102  may be improved in efficacy and thereby reduced treatment times that better align with proven outcomes. 
       FIG. 6  illustrates a flowchart illustrating an exemplary method  600  for tissue treatment and monitoring according to aspects of the present disclosure. In particular, the method  600  illustrates the operation of the system including the tissue engineering device  102 , UE  104 , server  108 , server  110 , and access device  114  according to embodiments of the present disclosure. For simplicity of discussion, reference is made to the devices in the singular, though embodiments of the present disclosure support the interaction of multiple devices within the system in similar manner. It is understood that additional steps can be provided before, during, and after the steps of method  600 , and that some of the steps described can be replaced or eliminated from the method  600 . 
     At block  602 , the tissue engineering device  102  monitors use (or nonuse) of the tissue engineering device  102 . This may occur, for example, by periodically polling one or more sensors associated with the tissue engineering device  102  as discussed above with respect to  FIG. 2  and also  FIG. 7A  below. Thus, for example, at times the result of the monitoring may identify that the tissue engineering device  102  is not in use, while at other times the determination is that it is in use. Block  602  may occur throughout the aspects discussed below (e.g., pairing devices, transferring data, receiving data, etc.). Further, the tissue engineering device  102  may display an overall treatment compliance indication at the tissue engineering device  102  (in addition to the information passed on to the UE  104 /server  108 ), such as a percentage compliant over time. 
     At block  604 , the tissue engineering device  102  pairs with a UE  104 . This may be a UE  104  of the patient with which the tissue engineering device  102  is also associated, and/or a UE  104  of another entity, such as a representative of the manufacturer or the prescribing physician, that is visiting the patient (or that the patient is visiting). The pairing may occur automatically, e.g. with the UE  104  being previously associated, or may be manually performed. 
     At block  606 , the tissue engineering device  102  transfers monitoring data to the UE  104 . The transfer may strip identifying data of the patient to comply with privacy requirements (and/or encrypt the data). This may be a real-time transfer of monitoring data as it is obtained, of monitoring data obtained over a prior period (e.g., either a set time frame or since a previous pairing), or some combination of both. For example, to conserve on power, the monitoring data may be transferred according to a schedule, e.g. once a day, and no further transfers are done automatically unless otherwise initiated manually by a user (e.g., by bringing an application in the paired UE  104  from a background process to an active, foreground process and requesting a data update) apart from essential communications such as regard error messages, battery status information, etc. as needed. 
     At block  608 , the UE  104  prompts a user of the UE  104  to input pain scale information with respect to the site of treatment (for example). The user may input the pain scale information via an interface of the UE  104  as discussed with respect to the embodiments above. Moreover, the UE  104  may prompt the user to also collect an image of the treatment site, whether on a periodic basis or in response to the pain scale information response exceeding a threshold (e.g., to make data available to assist a physician in determining whether an infection or other problem is occurring at the treatment site). This information may be collected at the same periodicity as the use of the tissue engineering device  102  specified in the treatment regimen. Thus, additional analysis may be performed by the UE  104  to discover broader trends for the patient, such as identifying whether the patient is more sedentary or mobile during each treatment session. The information, including level of mobility, may be aggregated over a longer time duration. 
     At block  610 , the UE  104  relays the monitoring data it receives to a server  108  and, where obtained, the pain scale information and/or image(s) collected of the treatment site, (and, where available, additional analysis performed by the UE such as the level of mobility to name just an example) by first further stripping the data (and/or encrypting) of any patient identifying data if further needed or not done previously, so as to comply with any privacy requirements for the patient while transmitting over a network  106  and storing at a server  108 . Similar to the communication between the tissue engineering device  102  and the UE  104 , the UE  104  may relay the monitoring data to the server  108  in real time or according to a schedule, e.g. once a day, unless otherwise initiated manually by a user (e.g., by bringing an application in the UE  104  from a background process to an active, foreground process and requesting a data update) apart from essential communications as needed. The monitoring data (referred to generally here to include both the data collected by the tissue engineering device  102  and the pain/image data collected by the UE  104 ) may be relayed by one or more networks  106  to which the UE  106  is in communication and which can reach the server  108 . 
     At block  612 , the server  108  which received the relayed monitoring data from the UE  104  generates a compliance report based on the relayed monitoring data. As part of this process, the server  108  may first re-associate the tissue engineering device  102  for which the monitoring data was sent to the appropriate patient in a database maintained by the server  108 . Therefore, the report may further be based on data stored previously about the particular patient/tissue engineering device  102 . 
     As part of generating the compliance reports at block  612 , the server  108  may further generate various permissions for the generated compliance report—these permissions may allow greater or reduced access to information in the reports, such that one level of permissions may limit the accessing entity from viewing any patient identifying information, while another level of permissions may allow the accessing entity to view the patient identifying information as well. Where the compliance report was generated by the UE  104  or tissue engineering device  102  already, and conveyed to the server  108 , block  612  may include the generation of permissions as discussed. Further, at the server  108  additional compliance information may be generated such as by comparing results from the patient&#39;s data to results of similar patients&#39; data made available through other sources, such as public registers or other reported outcomes. 
     At block  614 , the server  108  sends the compliance report to one or more subscribing devices, identified as the access devices  114  in  FIG. 1 . Where different levels of permissions are included, the server  108  may send the compliance report (or make available at the server  108 , with the sending the compliance report being a message notifying the recipient of availability of the report to be accessed) with the permission level included to the various access devices  114 . In some embodiments, the compliance report may be modified at the server  108  according to the level of permission of the target recipient, and then sent, while in other embodiments the compliance report may be broadcast and each access device  114  may only be able to access based on a level of permission stored at the access device  114 . 
     At block  616 , the subscribing access device(s)  114  that received the compliance report from the server  108  may present the compliance report, or some portion thereof, to a user of the access device  114 . For example, the user may be a representative of the prescribing physician for the tissue engineering device  102 , looking to monitor a level of compliance with the prescribed treatment regimen and/or pain management. With respect to pain management, this may include a prediction of future pain scale increases based on an amount of activity identified by the user (e.g., playing a sport during the treatment regimen, a physically demanding job, etc.) based on an increase of physical activity now. As another example, the user may be a party related to the patient, such as a spouse, parent, or child, etc. 
     At block  618 , the access device  114  that received the compliance report at block  616  receives input, if any, from a user of the access device  114  via one or more inputs such as text, voice, and video. The input may include a simple acknowledgment of receipt of the compliance report, a message intended for the patient using the tissue engineering device  102 , a change in treatment regimen input by the prescribing physician, and/or a reminder about compliance. 
     At block  620 , the access device  114  that received the input at block  618  relays the input to the patient of the tissue engineering device  102 , for example by forwarding the input to the server  110  (where included), server  108 , via network  106 , and to the UE  104  for display there and/or forwarding on to the tissue engineering device  102 . 
     The actions described above with respect to  FIG. 6  may continue over multiple periodic applications (e.g., where a periodic application occurs once a day for a specified number of hours, the above may occur over multiple days/weeks/months as treatment should continue according to the prescribed treatment regimen). 
     Turning now to  FIG. 7A , a flowchart illustrating an exemplary method  700  for tissue treatment device sensor polling is provided according to aspects of the present disclosure. In particular, the method  700  illustrates aspects of operation of the tissue engineering device  102  according to embodiments of the present disclosure. It is understood that additional steps can be provided before, during, and after the steps of method  700 , and that some of the steps described can be replaced or eliminated from the method  700 . 
     At block  702 , a processor of the tissue engineering device  102  polls a first sensor to identify whether some tissue of the patient is within a threshold proximity of the first sensor (and, therefore, within a threshold proximity of the tissue engineering device  102 ). For example, the first sensor may be an infrared sensor and/or a capacitive sensor that is polled periodically. 
     At decision block  704 , if the information from the first sensor as a result of the poll at block  702  indicates that the tissue engineering device  102  is not within the threshold proximity to the patient, then the method  700  returns to block  702  to poll again until it is determined that the tissue engineering device  102  is within the threshold proximity to the tissue of the patient. 
     If, at decision block  704 , it is determined (e.g., by processor  202  of the tissue engineering device  102 ) that the tissue engineering device is within the threshold proximity of the tissue of the patient, then the method  700  proceeds to block  706 . 
     At block  706 , the processor of the tissue engineering device  102  polls a second sensor. For example, the second sensor may be used to identify whether the tissue engineering device  102  is actually in use by the patient, such as to skirt attempts to dupe a sensor (e.g., the patient placing the tissue engineering device  102  on a running washing machine that generates a false positive where one of the sensors is an accelerometer, etc.). As an example, the second sensor may be an accelerometer (and/or a gyroscope, either operating in cooperation with the accelerometer or in place of the accelerometer). 
     The method  700  proceeds to decision block  708 . The method  700  may include multiple polling periods. A first polling period may be short, such as every 100 ms. A second polling period may be longer than the first polling period, such that multiple first polling periods may occur during a second polling period. For example, the second polling period may have a duration of 3 seconds or 30 seconds. A third polling period may be longer than the first and second polling periods, such that multiple first and second polling periods may occur during a third polling period. For example, the third polling period may have a duration of 30 seconds, multiple minutes, or multiple tens of minutes. The numbers given herein are exemplary only. Further, the number of polling periods is exemplary—more or fewer may be included according to embodiments of the present disclosure. 
     At decision block  708 , if a third polling period time has not yet elapsed, then the method  700  proceeds to decision block  712 . 
     At decision block  712 , if a second polling period (i.e., a polling period shorter than the third polling period but longer than the first polling period) time has not yet elapsed, then the method  700  proceeds to decision block  716 . 
     At decision block  716 , if a first polling period (i.e. a polling period shorter than the other polling periods) time has not elapsed, then the method  700  returns to block  702  for further polling. Otherwise, the method  700  proceeds to block  718 . 
     At block  718 , if any motion has been detected by the second sensor (as identified from the poll at block  706 ), then the processor  202  records a “yes” for the first polling period. This indicates that motion has been detected by the second sensor during the first polling period. Otherwise, if no motion is detected during the first polling period then a “no” is recorded. The method  700  then proceeds back to block  702  as laid out above. 
     Returning to decision block  712 , if the second polling period time has elapsed (therefore meaning that multiple first polling periods have occurred, each with respective “yes” or “no” results recorded), then the method  700  proceeds to block  714 . 
     At block  714 , the processor  202  determines whether motion has been detected more than 50% of the chunks of time (referring to each polling period as a “chunk of time”; in this example, more than 50% of the first polling periods that occur within a second polling period). Thus, the processor  202  may determine whether more than 50% of the first polling periods within the second polling period have a “yes” associated therewith. The value of 50% is exemplary in association with the second polling period. The percentage may be greater or less than this value, so long as it is greater than a percentage value associated with the third polling period as discussed further below. If more than 50% of the first polling periods have a “yes” recorded therewith, then the processor  202  records a “yes” for the second polling period. The method  700  then proceeds back to block  702  as laid out above. 
     Returning to decision block  708 , if the third polling period time has elapsed (therefore meaning that multiple first and second polling periods have occurred, each with respective “yes” or “no” results recorded), then the method  700  proceeds to block  710 . 
     At block  710 , the processor  202  determines whether motion has been detected more than 25% of chunks of time (in this example, more than 25% of the second polling periods that occur within a third polling period—alternatively, this may also look at the first polling periods that occur within the third polling period). Thus, the processor  202  may determine whether more than 25% of the second polling periods within the third polling period have a “yes” associated therewith. The value of 25% is exemplary in association with the third polling period. The percentage may be greater or less than this value, so long as it is less than the percentage value associated with the second polling period. If more than 25% of the second polling periods have a “yes” recorded therewith, then the method  700  records a “yes” for the third polling period. The method  700  then proceeds back to block  702  as laid out above. 
     The “yes” values recorded for the third polling periods may be interpreted to mean that the tissue engineering device  102  has been used in proximity to the tissue of the patient during the course of the third polling period of time. The data provided to the UE  104  when paired with the tissue engineering device  102  may include the results from the third polling period only, or some or all of the polling periods for further refining where compliance reports are generated, for example as discussed with respect to  FIG. 7B . 
       FIG. 7B  is a flowchart illustrating an exemplary method  750  for tissue treatment device compliance monitoring according to aspects of the present disclosure. In particular, the method  750  illustrates additional aspects of operation of the tissue engineering device  102  according to embodiments of the present disclosure. It is understood that additional steps can be provided before, during, and after the steps of method  750 , and that some of the steps described can be replaced or eliminated from the method  750 . 
     At block  700 , one or more sensors are polled by a processor of the tissue engineering device  102 . For example, the first and second sensors discussed with respect to  FIG. 7A  above are polled according to the method  700  discussed above. As a further example, other sensors may also be polled, such as an impedance monitor sensor (e.g., to identify healing progression of specific musculoskeletal tissues) and/or a GPS sensor. For purposes of this discussion, an impedance monitor will be described. 
     At decision block  752 , if the tissue engineering device  102  detects a pairable UE  104  (e.g., via a BLE connection or other type of wired and/or wireless connection), then the method  750  proceeds to block  754 . 
     At block  754 , the tissue engineering device  102  pairs with the UE  104  detected at decision block  752 . This pairing may occur according to the wired and/or wireless connection identified at decision block  752 . 
     At block  756 , the tissue engineering device  102  may receive a time of day from the UE  104  paired at block  754 . This is illustrated with dashed lines to indicate the optionality of this feature. This may be useful where the tissue engineering device  102  is first being used and paired with a UE  104 , so that the time at the tissue engineering device  102  may be set to correspond to the time zone and/or time of the paired UE  104  (for example, where the UE  104  obtains its time from a network  106 ). This may be further useful in situations where the tissue engineering device  102  is transported to a different time zone, so that reminders may be coordinated with the UE  104 . 
     Whether or not block  756  occurs, at decision block  758  if an impedance monitor sensor is included and operating, then the method proceeds to block  760 . Returning to decision block  752 , if the tissue engineering device  102  does not detect a pairable UE  104 , then the method  750  proceeds to decision block  758 . 
     At block  760 , the data obtained from the impedance monitor sensor are used to measure a repair status of the monitored tissue. For example, impedance spectroscopy may be used to identify different types of tissue of the patient and correlate that to the known types of tissues present in the different stages of healing. Based on this correlation, an estimate of the progress of healing may be made. 
     At block  762 , the tissue engineering device  102  may include the measured repair status from block  760  with the other monitoring data (e.g., the data provided from method  700 ) that is transmitted to the UE  104  for generation (at the UE  104  and/or the server  108 ) of compliance reports and otherwise banking in one or more databases. 
     At block  764 , the measured repair status data is transmitted to the server  108 , whether relayed via the UE  104  or otherwise sent to the server  108 . This may be transmitted with the other data, such as when included at block  762 , or sent independently therefrom. 
     Returning to decision block  758 , where no impedance monitor is included (or it is not operating), then the method  750  proceeds to block  764 . In situations where the method  750  reached decision block  758  because the tissue engineering device  102  is not paired with a UE  104 , the data may be transmitted at block  764  as noted above where a UE  104  is not required to relay. If, however, a relay is required, the method  750  may enter a delay pattern until a UE  104  is detected and pairing occurs and/or more data from the sensors are polled. Further, where the relay further (or alternatively) includes pairing with a transceiver in a coupled accessory (e.g., power supply or docking station), whether to communicate with UE  104  or network  106 , a delay pattern may be entered until the connection to the transceiver is made, and thereafter until a UE  104  is detected and pairing occurs. As noted above, in some embodiments the tissue engineering device  102  transmits data that it collects without further analysis, while in other embodiments the tissue engineering device  102  may display an overall treatment compliance indication at the tissue engineering device  102  (in addition to the information passed on to the UE  104 /server  108 ), such as a percentage compliant over time. 
     From block  764 , the method  750  proceeds to decision block  766 . At decision block  766 , if any update has been received from the server  108  (whether relayed by UE  104  or not), then the method  750  proceeds to block  768 . The update may be, for example, a change in the prescribed treatment regime (e.g., based on the prescribing physician reviewing a compliance report that may include both compliance and impedance monitor data) made via an access device  114  and routed through the server  108  (and server  110 , where applicable). 
     At block  768 , the update is implemented by the tissue engineering device  102  (for example, storing the update in local memory to implement in terms of reminders of the schedule, treatment parameters when treatment occurs, etc.). The method  750  returns to block  700  to continue polling sensors. 
     Returning to decision block  766 , if no update is received, then the method  750  returns to block  700  to continue polling sensors. 
     Turning now to  FIG. 8 , a flowchart illustrating an exemplary method  800  for tissue treatment device compliance monitoring is provided according to aspects of the present disclosure. In particular, the method  800  illustrates aspects of operation of the server  108  according to embodiments of the present disclosure. For simplicity of discussion, description will be made with respect to a single tissue engineering device  102  in communication with the server  108  via a network  106  and UE  104 , though it is understood that the server  108  may be in communication with any number of tissue engineering devices  102  via any number of UEs  104  and networks  106 . It is understood that additional steps can be provided before, during, and after the steps of method  800 , and that some of the steps described can be replaced or eliminated from the method  800 . 
     At block  802 , the server  108  receives data from a tissue engineering device  102 . This data may include compliance information over a prior time period (e.g., the third polling period described in  FIG. 7A  and/or the other polling periods) and/or impedance monitoring data. The data may be received at block  802  from the tissue engineering device  102  via a relaying UE  104  paired with the tissue engineering device  102 , or where the relaying UE  104  is not required from network  106  (or, under either approach, from a connected accessory (e.g., power supply or docking station as just some examples). Moreover, pain scale information may be received from UE  104  and/or image data of the treatment site, as collected by the UE  104 . Thus, the data the server  108  receives from block  802  may be from both the tissue engineering device  102  and the UE  104 , or all from the UE  104  where the UE  104  serves as a relay for the tissue engineering device  102 . The data may be received without any analysis having been performed yet, or with some analysis at the tissue engineering device  102  (e.g., overall compliance such as percentage compliant), the UE  104  (e.g., additional trend analysis to discover broader trends including a mobility level of the patient), or a combination of both. In some embodiments, the data is received with any patient identifying information stripped (and/or with the data encrypted). The data may instead identify nothing more than the tissue engineering device  102  itself (e.g., serial number or other identifier). 
     At block  804 , where patient identifying information has been stripped (e.g., to comply with privacy requirements where applicable), the server  108  associates the received data with an appropriate patient profile maintained in a database  408  of the server  108 . For example, the database  408  may store the device identifiers in association with the patients to which those tissue engineering devices  102  have been prescribed and provided. Thus, the server  108  may look up the identifier of the tissue engineering device  102  to identify the patient to which it has been provided. Where the data was encrypted, the server  108  decrypts the data (whether with the information stripped or not). 
     At block  806 , the server  108  aggregates data for the tissue engineering device  102  as it is received (whether that is periodically, real time, on demand, etc.), and stores the data with the patient profile identified from block  804 . 
     At decision block  808 , if it is determined that it is not time to generate a compliance report (e.g., the prescribing physician has set a report generation period, such as weekly/monthly/some other time frame and/or the manufacturer has set a default report generation period), then the method  800  returns to block  802 . 
     If, instead, it is time to generate a compliance report, then the method  800  proceeds to block  810 . At block  810 , the server  108  generates a compliance report based on the data received in the previous steps. This may occur whether or not the UE  104  also generates a compliance report (and/or whether or not the tissue engineering device  102  did an initial analysis to display an overall compliance at the tissue engineering device  102 )—for example, where the UE  104  also generates a compliance report, the server  108 &#39;s generation of a compliance report may involve including patient identifying information to the compliance report, including access permissions to the compliance report, comparing patent data results with similar patients&#39; data from other sources, and/or generating a new compliance report that aggregates multiple shorter-term compliance reports from the UE  104  based on aggregated data in the database  408  over a set period of time. 
     With the compliance report generated at block  810 , the method  800  proceeds to decision block  812 . At decision block  812 , the server  108  may automatically determine based on the generated compliance report whether a lapse in compliance has occurred. This may be done by comparing the content of the compliance report against a threshold compliance amount (e.g., a threshold compliance percentage, a threshold number of compliant days, and/or a threshold number of compliant treatment periodic applications to name some examples). If below the threshold, then the method  800  may proceed to block  814 . 
     At block  814 , the server  108  generates a note that may be included in the compliance report that identifies the failure in compliance for further review, and/or may generate a compliance reminder for the patient. 
     At block  816 , the server  108  may send the reminder where generated to the tissue engineering device  102 . This reminder may be expressly targeted to a UE  104  that is associated with the patient that is supposed to use the tissue engineering device  102 , as well as (or alternatively) to the tissue engineering device  102  itself for its display. The reminder may be further sent to other interested, subscribed (or otherwise associated) parties to the patient, such as spouses, parents, children, etc. 
     At block  818 , the server  108  sends the compliance report generated at block  810  to access device(s)  114  that have been subscribed for the particular patient. For example, the access devices  114  may include devices associated with the patient, with relatives of the patient, friends of the patient, the prescribing physician, and/or a representative of the manufacturer of the tissue engineering device  102  (or provider of the server  108  or server  110 ). 
     Where the generation of the compliance report included permissions, the compliance report at block  818  may be provided to the different access devices  114  according to their respective permission levels. Although described as being provided to the access devices  114  (e.g., pushed to those devices), this may alternatively describe the compliance report being made available via a portal (such as provided by server  110 ) for access by the access devices  114  on demand, or some combination thereof. 
     Returning to decision block  812 , if no lapse in compliance has been automatically detected, then the method  800  may proceed to block  818  as discussed above, and proceed from there to decision block  820 . 
     At decision block  820 , if any update has been received from an access device  114  (e.g., from the prescribing physician), then the method  800  proceeds to block  822 . The update may be, for example, a change in the prescribed treatment regime (e.g., based on the prescribing physician reviewing a compliance report that may include compliance and impedance monitor data, pain scale information, and/or treatment site image(s), or some sub-combination thereof) made via an access device  114  (and optionally routed through server  110 ). 
     At block  822 , the server  108  updates the treatment regimen in its database  408  according to the update received as determined at decision block  820 . This is useful so that future compliance reports reflect updated and accurate information. The server  108  also sends the update to the tissue engineering device  102  (whether relayed via a UE  104  or not). Where the update is (or includes) a message for the patient, this may be relayed to the patient. 
     If, at decision block  820 , an update/message has not been received, then the method  800  returns to block  802  and proceeds as laid out above. 
     Turning now to  FIG. 9 , a flowchart illustrating an exemplary method  900  for tissue treatment device compliance monitoring is provided according to aspects of the present disclosure. In particular, the method  900  illustrates aspects of operation of the UE  104  according to embodiments of the present disclosure. For simplicity of discussion, description will be made with respect to a single tissue engineering device  102  in communication with the UE  104 , as well as a single server  108 , though it is understood that the UE  104  may be in communication with any number of tissue engineering devices  102  and/or any number of servers  108 . It is understood that additional steps can be provided before, during, and after the steps of method  900 , and that some of the steps described can be replaced or eliminated from the method  900 . 
     At block  902 , the UE  104  maintains a treatment calendar (e.g., via the compliance module  308  discussed with respect to  FIG. 3  above). This may include tracking the treatment regimen in view of the current time of day, entering any reminders provided by a user of the UE  104 /received from the server  108 , providing the interactive interface for the calendar to the user of the UE  104 , etc. 
     At decision block  904 , if a reminder is scheduled, then the method  900  proceeds to block  906 . 
     At block  906 , the UE  104  determines a current treatment status for a tissue engineering device  102  associated with the UE  104  for a current periodic application of the long-term treatment regimen (e.g., treatment status for a given day of a multi-day treatment regimen). This includes accessing the most recent compliance data received from the tissue engineering device  102  (e.g., the monitoring data provided at block  606  of  FIG. 6  or block  764  of  FIG. 7B , which may include or be based on historical data) and comparing the compliance data to the treatment regimen (which may be stored locally or requested from the server  108 ). 
     At decision block  908 , if partial treatment has occurred for the current periodic application of the treatment regimen, then the method  900  proceeds to block  910 . 
     At block  910 , the UE  104  modifies the content of a scheduled reminder for the patient/user of the UE  104 , thereby implementing a dynamic alert. For example, where on a given day the patient completes the treatment prior to a time for which reminders are scheduled, the compliance module  308  may cancel the reminder for that day. If, however, the time of day that the treatment occurs is important, the compliance module  308  may allow the alert to be, instead of a typical alert to treatment, a reminder that the time of day of treatment is important (where applicable) to the treatment in addition to the periodicity and duration. Where treatment is partially completed for the day when the reminder is scheduled, the reminder may be modified in its content and/or intensity to account for the amount of treatment already determined to be completed (e.g., from data already received from a paired tissue engineering device  102 ). 
     Further, compliance over time (i.e., multiple periodic applications) may be taken into account when determining whether to dynamically modify the alert). Thus, for example, where the patient is compliant with treatment over time, the reminders may be minimized to a system tray reminder without audible and/or other visual alerts. If, however, the compliance is below a threshold, the alerts may become more aggressive, with audible alerts, changing volume (e.g., higher volume as percent compliant goes down over time), intrusive visual displays (e.g., to disrupt text reading), as well as potentially short audible reminders during phone use. The intensity of the reminders may increase as the level of compliance is determined to be decreasing over time, so as to encourage patient compliance with a treatment regimen designed for patient efficacy. 
     At block  912 , the UE  104  displays the reminder as modified (if at all) from block  910  on a display of the UE  104 . Further, or alternatively, the UE  104  may send the reminder as modified to the tissue engineering device  102  (where already paired to the tissue engineering device  102 ) to cause the tissue engineering device  102  display the reminder/alert. 
     Returning to decision block  908 , if partial treatment has not occurred, then the method  900  proceeds to block  912  (with no dynamic modification of the reminder) and proceeds with displaying the reminder. 
     From block  912 , the method  900  proceeds to block  914 . At block  914 , the UE  104  listens for the tissue engineering device  102  (or for any number of tissue engineering devices  102 ). 
     Returning to decision block  904 , if no reminder is scheduled, then the method  900  proceeds to block  914  as laid out above. 
     From block  914 , the method  900  proceeds to decision block  916 . If no tissue engineering devices  102  are detected, or otherwise not in range of the UE  104 , then the method returns to block  914  to continue listening for a tissue engineering device  102  to pair with (e.g., to receive monitoring data and/or send messages/updates received from the server  108 ). As used herein, listening for a tissue engineering device  102  includes embodiments where the tissue engineering device  102  includes a transceiver  212  and embodiments where the transceiver  212  is connected to the tissue engineering device  102  as part of a power supply or docking station (to name just a few examples). 
     If, instead, a tissue engineering device  102  is detected as in range, then the method  900  proceeds to block  918 . 
     At block  918 , the UE  104  pairs with the tissue engineering device  102 . This pairing may occur according to a wired and/or wireless connection, such as any one or more connection types as discussed above. 
     At block  920 , the UE  104  receives monitoring data from the tissue engineering device  102  that paired at block  918 . This may include, in addition to the compliance monitoring data, impedance monitoring data used to estimate healing of the tissue. 
     At block  922 , the UE  104  prompts the user of the UE  104  to input pain scale information with respect to the site of treatment (for example). Moreover, the UE  104  may prompt the user to also collect an image of the treatment site, whether on a periodic basis or in response to the pain scale information response exceeding a threshold (e.g., to make data available to assist a physician in determining whether an infection or other problem is occurring at the treatment site). This information may be collected at the same periodicity as the use of the tissue engineering device  102  specified in the treatment regimen. Although described with respect to  FIG. 9  as occurring at the same time as the receipt of monitoring data from the tissue engineering device  102 , the pain scale information and/or image collection prompting may occur according to a schedule that is unrelated to the receipt of monitoring data (though may still occur on a same periodic basis, such as daily, albeit not required to occur at the same time as the monitoring data is received). The prompt may occur with, e.g. be triggered by, the monitoring data received at block  920 . Additional analysis may also be performed by the UE  104  to discover broader trends for the patient, such as identifying whether the patient is more sedentary or mobile during each treatment session. The information, including level of mobility, may be aggregated over time. 
     At block  924 , the UE  104  relays the monitoring data received at block  920 , as well as the pain scale information and/or image(s) of the treatment site received/collected at block  922  (and trend information, where determined/available) to the server  108  for storage in the server  108 &#39;s database/compliance report generation. The UE  104  may relay the monitoring data when received, or according to a set schedule. 
     At decision block  926 , if any update has been received from an access device  114  via server  108  (e.g., from the prescribing physician), then the method  900  proceeds to block  928 . The update may be, for example, a change in the prescribed treatment regime (e.g., based on the prescribing physician reviewing a compliance report that may include both compliance and impedance monitor data, and pain scale information and/or image(s) of the treatment site) made via an access device  114  (and optionally routed through server  110 ). 
     At block  928 , the UE  104  updates a copy of the treatment regimen maintained at the UE  104  as specified in the update received as identified at decision block  926 . Where the update identified at decision block  926  is a message (e.g., from the prescribing physician), then the message may be displayed at the UE  104  if that is what is specified (e.g., instead of forwarding to the tissue engineering device  102 ). 
     At block  930 , the UE  104  sends the update to the tissue engineering device  102  so that the treatment regimen may be updated there as well. Where the update identified at decision block  926  is a message (e.g., from the prescribing physician), then this may be relayed to the tissue engineering device  102  where that is what is specified (e.g., instead of displaying at the UE  104 ). 
     At decision block  932 , if there are other tissue engineering devices  102  that were detected at block  914 , the method  900  may return to block  918  and proceed as discussed above and below. This may occur, for example, where the UE  104  is associated with a physician or representative of the manufacturer that may have opportunity to pair with multiple devices. 
     If, at decision block  932 , there are not other tissue engineering devices  102  that can be, or should be, paired with, then the method  900  proceeds to decision block  934 . 
     Returning to decision block  926 , if no update/message has been received from the server  108 , then the method  900  proceeds to decision block  934 . 
     At decision block  934 , if the UE  104  is still paired with the tissue engineering device  102 , then the method  900  returns to block  920  to continue receiving data. If, instead, the tissue engineering device  102  is no longer paired, then the method  900  returns to block  914  to listen for tissue engineering devices  102  as laid out above. 
     Through all of this in method  900 , the steps laid out at blocks  902  through  912  may continue to occur over time, whether concurrent to pairing with any devices or otherwise. 
     In some embodiments, the computing system is programmable and is programmed to execute processes including the processes of methods  600 ,  700 ,  750 ,  800  and/or  900  discussed herein. Accordingly, it is understood that any operation of the computing system according to the aspects of the present disclosure may be implemented by the computing system using corresponding instructions stored on or in a non-transitory computer readable medium accessible by the processing system. For the purposes of this description, a tangible computer-usable or computer-readable medium can be any apparatus that can store the program for use by or in connection with the instruction execution system, apparatus, or device. The medium may include for example non-volatile memory including magnetic storage, solid-state storage, optical storage, cache memory, and Random Access Memory (RAM). 
     As a result of implementing the above-described approach, embodiments of the present disclosure improve the field of pulsed electromagnetic field therapy for tissue engineering, such as for tissue differentiation and/or growth stimulation of tissue. In particular, embodiments of the present disclosure improve the transparency of treatment compliance so that more efficacious treatment regimens may be provided and prescribed to patients, whether at the onset of treatment or dynamically during treatment. The tissue engineering device itself may therefore be tuned to operate more efficiently for a given indication within a prescribed period of time as is now otherwise possible. This may therefore further improve clinical success rates of PEMF tissue engineering devices while still providing an energy-efficient tissue engineering device that is convenient for the patient to use according to prescribed usage. 
     The foregoing outlines features of several embodiments so that those skilled in the art may better understand the aspects of the present disclosure. Those skilled in the art should appreciate that they may readily use the present disclosure as a basis for designing or modifying other processes and structures for carrying out the same purposes and/or achieving the same advantages of the embodiments introduced herein. Those skilled in the art should also realize that such equivalent constructions do not depart from the spirit and scope of the present disclosure, and that they may make various changes, substitutions, and alterations herein without departing from the spirit and scope of the present disclosure.