System and method for collecting and displaying data acquired from implantable therapy device using consumer electronic device

Abstract

To provide a method for establishing communication between a therapy device implantable in a patient and a consumer electronic device operable by the patient.SOLUTION: The method comprises controlling, by a consumer electronic device 110, a predetermined set of therapy device functions in response to patient inputs to the consumer electronic device. The method also comprises transmitting therapy data from the therapy device to the consumer electronic device. The method further comprises presenting the therapy data on a display 120 of the consumer electronic device.SELECTED DRAWING: Figure 1A

Description

Summary of the Invention [Problem to be solved by the invention]

[0001] An embodiment relates to a method comprising establishing communication between a therapeutic device implantable within a patient and a consumer electrical device operable by the patient, the method comprising controlling, by the consumer electrical device, a predefined set of functions of the therapeutic device in response to patient input to the consumer electrical device, the method comprising transmitting therapy data from the therapeutic device to the consumer electrical device, the method further comprising displaying the therapy data on a display of the consumer electrical device.

[0002] An embodiment relates to a method comprising establishing communication between a therapeutic device implantable within a patient and a patient remote operable by the patient. The method comprises controlling, by the patient remote, a predefined set of functions of the therapeutic device in response to patient input to the patient remote. The method further comprises transmitting therapy data from the therapeutic device to the patient remote. The method further comprises transmitting therapy data from the patient remote to a consumer electronic device. The method further comprises displaying the therapy data on a display of the consumer electronic device.

[0003] An embodiment relates to a system comprising a therapeutic device implantable within a patient and a consumer electrical device operable by the patient, the consumer electrical device configured to control a predefined set of functions of the therapeutic device in response to patient input to the consumer electrical device, the consumer electrical device further configured to receive therapeutic data transmitted from the therapeutic device and display the therapeutic data on a display of the consumer electrical device.

[0004] An embodiment relates to a system comprising a treatment device implantable within a patient and a patient remote operable by the patient. The patient remote is configured to control a predefined set of functions of the treatment device in response to patient input to a consumer electrical device. The patient remote is configured to receive treatment data transmitted by the treatment device. The consumer electrical device is operable by the patient and configured to communicate with the patient remote. The consumer electrical device is further configured to receive the treatment data transmitted from the patient remote and display the treatment data on a display of the consumer electrical device.

[0005] The above summary is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The figures and detailed description that follow more particularly exemplify example embodiments.

[0006] Throughout the specification, reference will be made to the accompanying drawings, in which like reference numerals designate like elements and in which: [Brief description of the drawings]

[0007] [Figure 1A] 1 illustrates a system for collecting and displaying patient data, including data obtained from an implantable therapeutic device, according to various embodiments. [Figure 1B] 1 illustrates various control signals communicated between a consumer electrical device and an implantable therapeutic device according to various embodiments. [Figure 1C] 1 illustrates various types of therapy data that may be communicated from an implantable therapy device to a consumer electronic device according to various embodiments. [Figure 1D] 1 illustrates various types of device diagnostic data that may be communicated from an implantable therapeutic device to a consumer electronic device according to various embodiments. [Figure 2A] 1 illustrates a system for collecting and displaying patient data, including data obtained from an implantable therapeutic device, according to various embodiments. [Figure 2B]1 illustrates various control signals communicated between a consumer electrical device and an implantable therapeutic device according to various embodiments. [Figure 2C] 1 illustrates various types of therapy data that may be communicated from an implantable therapy device to a consumer electronic device according to various embodiments. [Figure 2D] 1 illustrates various types of device diagnostic data that may be communicated from an implantable therapeutic device to a consumer electronic device according to various embodiments. [Figure 3A] 1 illustrates an exemplary consumer electronic device configured to communicate with an implantable therapeutic device and / or a patient remote, according to various embodiments. [Figure 3B] 1 illustrates an exemplary implantable therapeutic device configured to provide therapy to a patient and to generate therapeutic and physiological data related to the patient, according to various embodiments. [Figure 3C] 1 illustrates an exemplary physiological sensor configured to generate sensor data associated with a particular patient, according to various embodiments. [Figure 3D] 1 illustrates an exemplary patient remote configured to wirelessly communicate with an implantable treatment device according to various embodiments. [Figure 3E] FIG. 3D is a representative set of patient controls that can be implemented by the patient remote. [Figure 4A] According to various embodiments, a method for obtaining data from an implantable therapeutic device and displaying the data using a consumer electronic device operated by a patient is presented. [Figure 4B] According to various embodiments, a method for obtaining data from an implantable therapeutic device using an intermediate device operated by a patient and displaying the data using a consumer electronic device operated by the patient is presented. [Diagram 5] 1 is a high-level site map of various screens and functions implemented by a consumer electronic device configured to receive and process therapy data obtained from an implantable therapy device according to various embodiments. [Figure 6] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 7] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 8] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 9] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 10] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 11] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 12] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 13] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 14] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 15]4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 16] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 17] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 18] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 19] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 20] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 21] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 22] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Diagram 23] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 24]4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Diagram 25] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 26] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 27] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 28] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 29] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Diagram 30] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Diagram 31] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Diagram 32] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 33A]4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 33B] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Diagram 34] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Diagram 35] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Diagram 36] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 37] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 38] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 39] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Diagram 40] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Diagram 41]4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Diagram 42] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Diagram 43] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Diagram 44] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Diagram 45] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 46] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 47] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 48] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 49] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 50]4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 51] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 52] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Diagram 53] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 54] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 55] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 56] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 57] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 58] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 59]4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 60] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 61] 4 is a screen that may be displayed on a display of a consumer electronic device based on an application executed by a processor of the consumer electronic device according to various embodiments. [Figure 62] 1 illustrates an exemplary wireless programmer configured to communicate with an implantable therapeutic device, according to various embodiments. [Figure 63A] 1 illustrates an exemplary treatment device implanted within a patient, according to various embodiments. [Figure 63B] 1 illustrates an exemplary treatment device implanted within a patient, according to various embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] The drawings are not necessarily to scale. Like numbers used in the drawings indicate like elements. However, it will be understood that the use of a number to refer to an element in one drawing is not intended to limit the element labeled with the same number in other drawings.

[0009] In the following description, reference will be made to the accompanying set of drawings, which form a part of the description herein, and in which, by way of example, several specific embodiments are shown. It will be understood that other embodiments are contemplated and may be made without departing from the scope of the present disclosure. Accordingly, the following detailed description is not to be taken in a limiting sense.

[0010] Many treatments include patient choice, for example, the need for the patient to turn on, enable, or change various treatment parameters. Treatments involving patient choice face challenges with patient adherence. Clinicians lack insight into treatment utilization and outcomes when the patient is out of the clinic or between visits. However, day-to-day utilization and outcomes are more important to health outcomes than acute assessments performed by clinicians during patient visits. Correlating utilization with objective and subjective assessments of treatment outcomes is difficult for patients and clinicians. This challenge is further complicated by the long time periods between patient visits. Existing methods can display numerical values ​​of utilization and / or disease state, but do not display the correlation between the two in a way that is easily understandable. Thus, desired patient behavior based on that information may not follow.

[0011] Embodiments of the present disclosure relate to collecting configuration, usage, and outcome data directly from therapeutic medical devices. Embodiments of the present disclosure blend device data with subjective and objective data sources to form a holistic clinical picture. Embodiments of the present disclosure include collecting patient data on the patient's personal computing device and blending that data with subjective and objective outcomes.

[0012] The term "consumer electrical device" as used herein includes a wide variety of devices that are not subject to medical regulatory agency approval (e.g., FDA approval). Examples of consumer electrical devices include various portable (e.g., handheld) computer and communication devices, such as laptops, notebooks, tablets, phablets, personal digital assistants, mobile phones, and smartphones. In some cases, a consumer electrical device may be a personal computer (PC). A consumer electrical device includes one or more communication devices that facilitate communication between the consumer electrical device and a medical device, such as a medical device that is subject to medical regulatory agency approval. For example, a consumer electrical device may include one or more of Bluetooth, ZigBee, or IEEE 802.11 compliant communication interfaces. A consumer electrical device may include one or more communication devices that facilitate communication between the consumer electrical device and one or more physiological sensors, monitoring devices, and / or personal health devices via Bluetooth, ZigBee, IEEE 802.11, or ISO / IEEE 11073 compliant communication interfaces. A consumer electronic device may include one or more communication devices such that the consumer electronic device can communicate with a public communication infrastructure (e.g., the Internet) and / or a private communication infrastructure. For example, the one or more communication devices may be configured to provide wireless communication through a Global System for Mobile Communications (GSM), Code Division Multiple Access (CDMA), General Packet Radio Service (GPRS), and / or High-Speed ​​Downlink Packet Access (HSDPA) communication interface.

[0013] The term "app" as used herein generally refers to a software application (e.g., program code) executed by a processor, such as, for example, the processor of a consumer electronic device. In one embodiment, an app refers to a software application executable by a processor of a portable device, such as a laptop, notebook, tablet, phablet, personal digital assistant, or smartphone. Various app platforms exist for different operating systems, such as the Apple iOS® platform, the Google Android® platform, Microsoft Windows®, and the like. For example, an app of the present disclosure may be implemented to run on smartphones, such as the Apple iPhone® or Samsung Galaxy®, tablets, such as the Apple iPad® or Google Nexus®, embedded devices running the Google Android® operating system, and computer operating systems, such as Apple Mac OS X® and Microsoft Windows 8®.

[0014] FIG. 1A illustrates a system for collecting and displaying patient data, including data obtained from an implantable therapeutic device, according to various embodiments. The system illustrated in FIG. 1A includes an implantable therapeutic device 102 configured to provide therapy to a patient. Representative examples of implantable therapeutic devices 102 are described herein and include those illustrated in FIGS. 63A and 63B. The implantable therapeutic device 102 is configured to communicate with a consumer electrical device 110 through a wireless (e.g., radio frequency) link. Among other elements, the consumer electrical device 110 includes a processor 112, a memory 114, an app 116 stored in the memory 114, and a user interface 118. The consumer electrical device 110 further includes a display 120, which may be an element of the user interface 118 (e.g., a touch screen). In one embodiment, the consumer electrical device 110 may be communicatively coupled to one or more physiological sensors 104 through a wired or wireless link. The one or more physiological sensors 104 may be coupled to or located near the patient.

[0015] The processor 112 of the consumer electronic device 110, when executing the program code of the app 116, is configured to communicate various control signals 103 to the implantable therapy device 102. For example, and with reference to FIG. 1B, the processor 112 can generate the control signal 103 to initiate communication between the implantable therapy device 102 and the consumer electronic device 110. The control signal 103 issued by the processor 112 may cause the processor of the implantable therapy device 102 to perform various patient-initiated functions in response to patient input to the user interface 118. For example, the processor 112 can generate the control signal 103 to cause the implantable therapy device 102 to initiate therapy delivery, to cause the implantable therapy device 102 to suspend therapy delivery, and to cause the implantable therapy device 102 to terminate therapy delivery. The processor 112 can generate the control signal 103 to cause the implantable therapy device 102 to increase or decrease the amplitude or magnitude of therapy delivery (e.g., increase or decrease the amplitude of stimulation) in response to patient input to the user interface 118. Other control signals 103 and corresponding device functions are contemplated, depending on the type and capabilities of the implantable therapeutic device 102. In one embodiment, communication between the consumer electrical device 110 and the implantable therapeutic device 102 may be secure, such as in the manner disclosed in co-pending U.S. Provisional Patent Application No. 62 / 203,435 (Londoni et al.), filed Aug. 11, 2015, which is incorporated herein by reference.

[0016] The processor 112 of the consumer electrical device 110, upon executing the program code of the app 116, is configured to communicate various control signals 107 to the one or more physiological sensors 104. The processor 112 may generate the control signals 107 to initiate communication between the consumer electrical device 110 and the one or more physiological sensors 104. The control signals 107 issued by the processor 112 may cause the processor or controller of the physiological sensor 104 to transmit the physiological data 106 from the memory of the physiological sensor 104 to the memory 114 of the consumer electrical device 110. It will be appreciated that the various types of physiological data 106 that may be received by the memory 114 of the consumer electrical device 110 may be generated by the implantable therapeutic device 102. It will be appreciated that the consumer electrical device 110 may include or incorporate one or more physiological sensors 104. For example, a microphone of the consumer electrical device 110 may function as a physiological sensor 104 to monitor the patient's breathing, breath sounds, and / or snoring.

[0017] The control signal 103 issued by the processor 112 of the consumer electronic device 110 may cause the processor of the implantable therapy device 102 to upload therapy data 105 from the memory of the implantable therapy device 102 to the memory 114 of the consumer electronic device 110. As shown in FIG. 1C, the therapy data 105 may include therapy usage, clinician programmed therapy settings, and patient programmed therapy settings. For example, the patient may use the user interface 118 to increase or decrease the stimulation amplitude of the therapy within a stimulation amplitude range preprogrammed by the clinician.

[0018] The control signal 103 issued to the processor 112 of the consumer electrical device 110 may cause the processor of the implantable therapy device 102 to transmit device diagnostic data 109 from the memory of the implantable therapy device 102 to the memory 114 of the consumer electrical device 110. For example, and with reference to FIG. 1D , the device diagnostic data 109 transmitted from the implantable therapy device 102 to the consumer electrical device 110 may include battery status, electrode status, communication device status, processor status, memory status, pulse generator status, fault code, and firmware / software version / status.

[0019] The user interface 118 of the consumer electrical device 110 is configured to allow the patient to input patient-generated data into the memory 114 of the consumer electrical device 110. The patient-generated data represents subjective data regarding the patient's health, such as overall health and specific parameters, such as fatigue level. The processor 112 may execute the program code of the app 116 to open a dialogue box on the display 120 in which the patient can input the subjective health information. The processor 112 may execute the program code of the app 116 or other apps to display a questionnaire or a series of questions from the clinician on the display 120 to be answered by the patient through the user interface 118. For example, the processor 112 in cooperation with the app 116 or other apps may display an Epworth sleepiness scale (ESS) questionnaire on the display 120, requiring the patient to answer eight questions, and the processor 112 calculates a sleepiness score from the answers.

[0020] The memory 114 of the consumer electronic device 110 collects patient medical data obtained from disparate sources, including the implantable therapeutic device 102, one or more physiological sensors 104, and the patient himself / herself. The processor 112 cooperates with the display 120 of the consumer electronic device 110 to display the various data stored in the memory 114. Desirably, the processor 112 and the display 120 cooperate to display the disparate patient medical data proximately on the display 120 and provide visual correlation of the disparate data by the patient.

[0021] For example, the therapy data 122 may be displayed near the physiological sensor data 124 on the display 120 to facilitate visual correlation between changes in disease status indicated in the physiological sensor data 124 in response to treatment provided to the patient. As a further example, the therapy data 122 may be displayed near the patient-generated data 126 on the display 120 to provide visual correlation between the therapy information and patient-subjective inputs (e.g., notes, questionnaire scores). In another example, the therapy data 122, the patient-generated data 126, and the goal / outcome data 130 may be displayed near each other on the display 120 to provide an indication of patient utilization and adherence to the therapy. In a further example, the therapy data 122, the patient-generated data 126, and the physiological sensor data 124 may be displayed near each other on the display 120 to provide visual correlation between changes in disease status and patient-subjective inputs in response to treatment provided to the patient.

[0022] FIG. 2A illustrates a system for collecting and displaying patient data, including data obtained from an implantable therapeutic device, according to various embodiments. The system illustrated in FIG. 2A includes an implantable therapeutic device 202 configured to provide therapy to a patient. The implantable therapeutic device 202 is configured to communicate with a patient remote 208 through a wireless (e.g., radio frequency inductive) link. The patient remote 208 may be used by the patient to adjust various operational parameters and / or functions of the implantable therapeutic device 202. Among other elements, the patient remote 208 includes a processor 209 coupled to a memory 221 and a user interface 213. The processor 209, upon executing the program code of the software stored in the memory 211, is configured to communicate various control signals 203a to the implantable therapeutic device 202. For example, referring to FIG. 2B, the processor 209 may generate the control signal 203a to initiate communication between the implantable therapeutic device 202 and the patient remote 208. 2B, the processor 209 can generate a control signal 203a to initiate communication between the implantable therapy device 202 and the patient remote 209. The control signal 203a emitted by the processor 209 may cause the processor of the implantable therapy device 202 to perform various patient-initiated functions in response to patient input to the user interface 213.

[0023] For example, the processor 209 of the patient remote 208 can generate control signals 203a that cause the implantable therapy device 202 to begin therapy delivery, the implantable therapy device 202 to cease therapy delivery, and the implantable therapy device 202 to terminate therapy delivery. The processor 209 can generate control signals 203a that cause the implantable therapy device 202 to increase or decrease the amplitude (or magnitude) of therapy delivery (e.g., increase or decrease the amplitude of stimulation) in response to patient input to the user interface 213. Other control signals 203a and corresponding device functions are contemplated that vary depending on the type and capabilities of the implantable therapy device 202.

[0024] The control signal 203a issued to the processor 209 may cause the processor of the implantable therapy device 202 to upload the therapy data 205 from the memory of the implantable therapy device 202 to the memory 211 of the patient remote 208. As shown in FIG. 2C, the therapy data 205 may include therapy usage, clinician programmed therapy settings, and patient programmed therapy settings. For example, the patient may use the user interface 213 to increase or decrease the stimulation amplitude of the therapy within a range of stimulation amplitudes preprogrammed by the clinician.

[0025] The control signal 203a issued by the processor 209 may cause the processor of the implantable therapy device 202 to transmit device diagnostic data 215 from the memory of the implantable therapy device 202 to the patient remote 208. For example, and with reference to FIGURE 2D, the device diagnostic data 215 transmitted from the implantable therapy device 202 to the patient remote 208 may include battery status, electrode status, communication device status, processor status, memory status, pulse generator status, fault code, and firmware / software version / status.

[0026] The patient remote 208 is configured to communicate with the consumer electrical device 210 through a wireless (e.g., radio frequency) link. Among other elements, the consumer electrical device 210 includes a processor 212, a memory 214, an app 216 stored on the memory 214, and a user interface 218. The consumer electrical device 210 further includes a display 220, which may be an element of the user interface 218 (e.g., a touch screen). The processor 212, when executing the program code of the app 216, may communicate a control signal 203c to the processor 209 of the patient remote 208 for reception and operation thereon. Similarly, the processor 209 of the patient remote 208 may communicate a control signal 203b to the processor 212 of the consumer electrical device 210 for reception and operation thereon. For example, the control signals 203b, 203c may be communicated between the two devices 208, 210 to initiate communication between the patient remote 208 and the consumer electrical device 212.

[0027] In response to patient input to the user interface 218 of the consumer electrical device 210, the processor 212 sends a control signal 203c causing the processor 209 of the patient remote 208 to send the therapy data 205 to the processor 212 for storage in the memory 214. Simultaneously, or in response to another control signal 203c, the device diagnostic data 215 is sent from the memory 211 of the patient remote 208 to the memory 214 of the consumer electrical device 210.

[0028] In an embodiment, the consumer electrical device 210 may be communicatively coupled to one or more physiological sensors 204 by a wired or wireless link. The one or more physiological sensors 204 may be coupled to or located near the patient and configured to sense / monitor the physiological signals or conditions described above. In an embodiment, the patient remote 208 may be communicatively coupled to one or more physiological sensors 204 by a wired or wireless link. The processor 209 of the consumer electrical device 210, when executing the program code of the app 216, is configured to communicate various control signals 207 to the one or more physiological sensors 204. The processor 212 may generate the control signals 207 to initiate communication between the consumer electrical device 210 and the one or more physiological sensors 204. The processor 212 may generate the control signals 207 to cause the one or more physiological sensors 204 to upload the physiological data 206 to the memory 214 of the consumer electrical device 210. It will be appreciated that various types of physiological data 206 may be generated by the implantable therapeutic device 202 and received by the memory 214 of the consumer electrical device 210 through the patient remote 208. It will be appreciated that the consumer electrical device 210 may include or incorporate one or more physiological sensors 204. For example, and as described above, a microphone of the consumer electrical device 210 may function as a physiological sensor 204 to monitor the patient's breathing, breath sounds, and / or snoring.

[0029] The user interface 218 of the consumer electrical device 210 is configured to allow the patient to input patient-generated data into the memory 214 of the consumer electrical device 210. The patient-generated data represents subjective data regarding the patient's health, such as, for example, general health and specific parameters such as fatigue level. The processor 212 may execute the program code of the app 216 to open a dialog box on the display 220 in which the subjective health information is entered by the patient. The processor 212 may execute the program code of the app 216 or another app to display a questionnaire or a series of clinician questions on the display 220 to be answered by the patient through the user interface 218. For example, the processor 212 in cooperation with the app 216 or another app may display an Epworth sleepiness scale (ESS) questionnaire on the display 220, requiring the patient to answer eight questions, and the processor 212 calculates the sleepiness scale from the answers.

[0030] The memory 214 of the consumer electronic device 210 collects patient medical data obtained from disparate sources, including the implantable therapy device 202, the patient remote 208, one or more physiological sensors 204, and the patient himself. The processor 212 cooperates with the display 220 of the consumer electronic device 210 to display the various data stored in the memory 214. Desirably, the processor 212 and the display 220 cooperate to display the disparate patient medical data in close proximity on the display 220 and provide visual correlation of the disparate data by the patient.

[0031] For example, the therapy data 222 may be displayed near the physiological sensor data 224 on the display 220 to facilitate visual correlation between changes in disease status indicated in the physiological sensor data 224 in response to treatment provided to the patient. As a further example, the therapy data 222 may be displayed near the patient-generated data 226 on the display 220 to provide visual correlation between the therapy information and patient-subjective inputs (e.g., notes, questionnaire scores). In another example, the therapy data 222, the patient-generated data 226, and / or the goal / outcome data 230 may be displayed near each other on the display 220 to provide an indication of patient utilization and adherence to the therapy. In a further example, the therapy data 222, the patient-generated data 226, and the physiological sensor data 224 may be displayed near each other on the display 220 to provide visual correlation between changes in disease status and patient-subjective inputs in response to treatment provided to the patient.

[0032] The implantable therapeutic device 102, 202 represents a wide variety of implantable therapeutic devices that can provide therapy to a patient. For example, the implantable therapeutic device 102, 202 may be an implantable pulse generator, a neurostimulator, a cardiac pacemaker, a resynchronizer, a cardioverter / defibrillator, a drug delivery device (e.g., an external or implantable drug pump), a diaphragm stimulator, a bladder stimulator, a cochlear implant, a hearing aid, a muscle stimulator, or other type of stimulation device. The implantable therapeutic device 102, 202 and / or one or more physiological sensors 104, 204 may be configured to detect and monitor one or more of oxygen saturation (e.g., pulse oximeter), sleep stages, respiration, snoring, posture (e.g., by accelerometer, sleep position, e.g., left, right, prone, supine), brain activity (e.g., electroencephalogram, EEG), muscle activity (e.g., electromyogram, EMG), glucose levels, mechanical cardiac activity (e.g., heart sounds, seismocardiogram, SCG), electrical cardiac activity (electrocardiogram, ECG), heart rate, heart rate variability, blood pressure, body temperature, and neural activity.

[0033] In one embodiment, the implantable therapeutic device 102, 202 is a neurostimulation device configured to provide neurostimulation therapy for treating an obstructive disordered breathing condition, a representative example of which is shown implanted in a patient in FIG. 63B. In such an embodiment, the neurostimulation device 102, 202 includes a neurostimulation device 102a and a stimulation lead 108 that extends from a housing of the neurostimulation device 102a to the hypoglossal nerve in the patient's neck. A sensing lead 109 extends from the housing of the neurostimulation device 102a and is implanted at the intercostal muscle level in the ribs. The sensing lead 109 detects movement of the intercostal muscles during patient respiration, and signals therefrom are used to detect patient respiration. A pulse generator within the neurostimulation device 102a provides electrical stimulation to the hypoglossal nerve through the stimulation lead based on sensed patient respiration. The patient remote (e.g., patient remote 208) can communicate with the neurostimulator 102a and allow the patient to adjust a predefined set of neurostimulator parameters and / or functions (e.g., therapy on, therapy off, therapy off, increase amplitude, decrease amplitude). In one embodiment, the patient remote can be implemented to provide the functionality of the patient remote disclosed in co-pending U.S. Pat. No. 9,839,786 (Londoni et al.) and U.S. Patent Application Publication No. 2016 / 0193468 (Londoni et al.), which are incorporated herein by reference. The neurostimulator 102a can be implemented to provide the functionality of the neurostimulator disclosed in U.S. Patent Application Publication No. 2016 / 0193468 (Londoni et al.).

[0034] FIGURE 3A illustrates an exemplary consumer electronic device configured for communication with an implantable therapy device and / or a patient remote, according to various embodiments. The consumer electronic device 302 is preferably a portable, handheld computing and / or communication device that is used daily by a patient. The consumer electronic device 302 illustrated in FIGURE 3A may represent a smartphone, tablet, phablet, or other personal digital assistant.

[0035] The consumer electrical device 302 includes a processor (CPU) 304 coupled to a flash memory 306 and a RAM 308. Firmware and software executable by the consumer electrical device 302 are stored in the flash memory 306 and transferred to the RAM 308 when executed by the CPU 304. The flash memory 306 preferably stores one or more apps that, when executed by the CPU 304, facilitate communication and interaction with the implantable medical device and / or the patient remote in accordance with the methods described herein. The flash memory 306 provides storage of data acquired from the implantable medical device and one or more physiological sensors, including therapy data, physiological data, and device diagnostic data. Patient-generated data is also stored in the flash memory 306. The touch screen 310 serves as an input / output user interface. One or more manual buttons 312 may be included to facilitate execution of various functions.

[0036] The consumer electronic device 302 includes a number of different radios, including a Wi-Fi radio 312, a Bluetooth radio 316, and a portable radio 318. In one embodiment, a ZigBee radio 315 may also be included. The Bluetooth radio 316 may provide communication via a regular Bluetooth protocol or a low energy Bluetooth (BLE) protocol. In one example, the portable radio 318 is powered by a dedicated power amplifier 320. The portable radio 318 may be configured to provide wireless communication based on one or more protocols, including GSM, CDMA, GPRS, and / or HSDPA. The consumer electronic device 302 may communicate with a network and / or the Internet via one or more radios 314, 315, 316, 318. For example, the consumer electronic device 302 may communicate data obtained from an implantable therapeutic device, one or more physiological sensors, and patient-generated data input by the patient to a remote server over the network and / or the Internet. The remote server may be configured to process data received from the consumer electrical device 302, and the consumer electrical device 302 may access the processed data from the remote server.

[0037] The consumer electronic device 302 may further include a camera 322, a headphone jack 324, a USB interface 326, a SIM card slot 328, a microSD slot 330, and up and down volume controls 331, 333. A power supply 334 (battery and power management circuitry) provides power to the various elements of the consumer electronic device 302.

[0038] The microphone 332 may be implemented to serve both as a conventional audio input device and, in some embodiments, as a physiological sensor. For example, the consumer electronic device 302 may be placed near the patient's face and the microphone 332 may be used to detect the patient's breathing, breath sounds, and snoring. One common symptom of obstructive sleep apnea is loud, chronic (persistent) snoring. The microphone 332 serves as a snore sensor. A snore tracking app (e.g., snore tracker app) stored in the flash memory 306 and executed by the CPU 304 can monitor the patient's snoring and generate snore data for display on the touch screen 310. The stored data represents objective disease state data that may be used to analyze breathing disorders such as sleep apnea.

[0039] In one embodiment, the microphone 332 may be used as a data input sensor configured to receive sound data from the patient remote. For example, the patient remote may include a sound transceiver (e.g., a piezoelectric or electromagnetic transducer, a buzzer, a speaker) that transmits sound data to the microphone 332 of the consumer electrical device 302. In one embodiment, the sound data is transmitted at a frequency (e.g., ultrasonic data) higher than the normal human hearing range. In other embodiments, the sound data is transmitted at a frequency within the normal human hearing range (e.g., <18-20 kHz) so that the patient can effectively hear the data transmission as an indicator of successful or unsuccessful communication between the consumer electrical device 302 and the patient remote. The sound data may be transmitted using digital modulation (e.g., phase shift keying) of a high frequency carrier. The consumer electrical device 302 may include a demodulator configured to demodulate the sound data transmitted using the digital modulation. It will be appreciated that in one embodiment, an external microphone (wireless or wired) may be used as a snore sensor. The external microphone may be communicatively coupled to the consumer electrical device 302 wirelessly (eg, a Bluetooth radio 316) or by a wired connection (eg, USB).

[0040] FIG. 3B illustrates an exemplary implantable therapy device configured to provide therapy to a patient and generate therapy and physiological data associated with the patient, according to various embodiments. The implantable therapy device 342 includes a processor 344 coupled to memory 346, 350. The processor 344 may be, for example, a microprocessor, an embedded microprocessor, an embedded controller, or a digital signal processor (DSP). The processor 344 is configured to execute program code stored as software 348 in a read-only memory (ROM) 346. The program code, when executed by the processor 344, causes the processor 344 to perform various therapy device functions described herein. The processor 344 cooperates with a memory 350 (e.g., flash, SRAM) to store therapy data 351 generated by / stored in the implantable therapy device 342, and physiological data generated by one or more sensors of the implantable therapy device 342. A rechargeable power source 356 provides power to the various elements of the implantable therapy device 342. The implantable therapy device 342 includes a therapy delivery module 358. The therapy delivery module 358 may include, for example, a pulse generator coupled to an electrode arrangement. The transceiver 354 is configured to facilitate wireless communication between the implantable therapy device 342 and other devices or systems (e.g., patient remotes, consumer electronic devices) according to any of the devices / protocols disclosed herein. The therapy data 351 and physiological data 352 stored in the memory 350 may be transmitted by the transceiver 354 to other devices or systems.

[0041] FIG. 3C illustrates an exemplary physiological sensor configured to generate sensor data associated with a particular patient, according to various embodiments. The physiological sensor 362 includes a processor 364 coupled to a memory 370. The processor 364 may be, for example, a microprocessor, an embedded microprocessor, an embedded controller, a digital signal processor, an ASIC, a field programmable gate array, or a programmable logic device. In one embodiment, the processor 364 is configured to execute program code stored as software in a non-volatile memory 375 (e.g., ROM) to perform various physiological sensor functions described herein. The processor 364 cooperates with a memory 370 (e.g., flash, SRAM) to store physiological data 372 acquired by a sensing element or arrangement 378. A power source 376, which may be rechargeable, provides power to the various elements of the physiological sensor 362.

[0042] The physiological sensor 362 includes a transceiver 374, which may be configured to facilitate wired or wireless communication between other devices or systems (e.g., consumer electronic device, patient remote) according to any of the devices / protocols disclosed herein. In one embodiment, the transceiver 374 is configured to facilitate communication between the physiological sensor 362 and a network or the Internet by a router and / or modem. In such an embodiment, the physiological data 372 may be communicated to the other device or system (e.g., consumer electronic device, patient remote, remote server) over the network or the Internet. In another embodiment, the transceiver 374 is configured to facilitate communication between the physiological sensor 362 and a transceiver of the other device or system (e.g., consumer electronic device, patient remote). The transceiver of the other device or system can transmit the physiological data 372 to a remote server or other remote device / system over the network or the Internet.

[0043] 3D illustrates an exemplary patient remote configured to wirelessly communicate with an implantable therapy device, according to various embodiments. The patient remote 382 includes a processor 384 coupled to a memory 390. The processor 384 may be, for example, a microprocessor, an embedded microprocessor, an embedded controller, or a digital signal processor (DSP). The processor 384 is configured to execute program code stored as software 396 in a read only memory (ROM) 395. The program code, when executed by the processor 384, causes the processor 384 to perform various patient remote functions described herein.

[0044] The transceiver 394 is configured to facilitate wireless communication between the patient remote 382 and the implantable therapy device through any device / protocol disclosed herein. The transceiver 394 is configured to facilitate wireless communication between the patient remote 382 and other devices or systems (e.g., consumer electronic devices, networks, the Internet, remote servers) through any device / protocol disclosed herein. Although shown as a single element, it will be understood that the transceiver 394 may represent two or more transceivers, each configured to implement a different communication protocol. In an embodiment, the transceiver 394 is configured to communicate with one or more physiologic sensors coupled to or positioned near the patient. Sensor data acquired by the one or more physiologic sensors may be stored as physiologic data 392 in the memory 390.

[0045] The processor 384 cooperates with a memory 390 (e.g., flash, SRAM) to store implantable therapy data 391 generated by / stored in the implantable therapy device, and physiological data 352 generated by one or more sensors (and optionally one or more additional physiological sensors) of the implantable therapy device. The therapy data 391 and physiological data 392 stored in the memory 390 may be transmitted by a transceiver 394 to other devices or systems (see examples above). A power source 376, which may be rechargeable, provides power to various elements of the patient remote 382. In one embodiment, the patient remote 382 may include a microphone 385, which may function as a respiration sensor to detect and monitor the patient's breathing and breathing disorders, such as the patient's snoring. Snoring data may be stored in the memory 390 as physiological data 392.

[0046] The patient remote 382 includes a user interface 393 and a display 395. In some embodiments, the user interface 393 includes a number of manually actuated buttons, such as mechanical or capacitive buttons. In such embodiments, the display 395 may be a general display (e.g., LED, OLED, LCD, E-ink). In other embodiments, the display 395 is implemented as a touch screen that may function as the user interface 393, alone or in combination with one or more manually actuated buttons. FIG. 3E is a representative set of patient controls 398 that may be implemented by the user interface 393 and / or the display 395.

[0047] The patient controls 398 include a connection control 381 that, when activated by the patient, causes the processor 384 and transceiver 394 to initiate communication with the implantable therapy device. Activation of the connection control 381 may facilitate communication between the patient remote 382 and other systems or devices, such as consumer electronic devices. The patient controls 398 include a start therapy button 383, a pause therapy button 385, and a therapy off button 387 that, respectively, cause the implantable therapy device to initiate therapy delivery (in some cases after a predefined start delay, such as 15 minutes), pause therapy delivery, and end therapy delivery. The increase amplitude button 397 and decrease amplitude button 399, when activated by the patient, cause the implantable therapy device to increase and decrease, respectively, the amplitude or magnitude of the therapy being delivered. For example, the amplitude of the neurostimulation therapy delivered by the implantable therapy device may be increased or decreased by the increase amplitude 397 and decrease amplitude 399 buttons.

[0048] FIG. 4A illustrates a method of obtaining data from an implantable therapeutic device and displaying the data using a patient operated consumer electrical device according to various embodiments. The method illustrated in FIG. 4A includes establishing 402 communication between a therapeutic device implantable within a patient and a patient operated consumer electrical device. The method includes controlling 404, by the consumer electrical device, a predefined set of therapeutic device functions in response to patient input to the consumer electrical device. The method further includes transmitting 406 therapy data from the therapeutic device to the consumer electrical device. In an embodiment, physiological data generated by the therapeutic device is transmitted to the consumer electrical device along with the therapy data. The method further includes displaying 408 the therapy data on a display of the consumer electrical device. In an embodiment, the physiological data and the therapy data are displayed on a display of the consumer electrical device. In a further embodiment, patient generated data is input by the patient into the consumer electrical device. The patient generated data, therapy data, and optionally, physiological data may be displayed on a display of the consumer electrical device.

[0049] FIG. 4B illustrates a method of obtaining data from an implantable therapeutic device using a patient-operated intermediate device and displaying the data using a patient-operated consumer electronic device according to various embodiments. The method illustrated in FIG. 4B includes establishing 420 communication between a therapeutic device implantable within a patient and a patient remote operable by the patient. The method includes controlling 422 a predefined set of therapeutic device functions by the patient remote in response to patient input to the patient remote. The method includes transmitting 424 therapy data from the therapeutic device to the patient remote. In an embodiment, physiological data generated by the therapeutic device is transmitted to the patient remote along with the therapy data. The method further includes transmitting 426 therapy data from the patient remote to the consumer electronic device. In an embodiment, the physiological data generated by the therapeutic device and the therapy data are transmitted from the patient remote to the consumer electronic device. The method includes displaying 428 the therapy data on a display of the consumer electronic device. In an embodiment, the physiological data and the therapy data are displayed on a display of the consumer electronic device. In a further embodiment, patient-generated data is input by the patient into the consumer electronic device. The patient generated data, the therapy data and, optionally, the physiological data may be displayed on a display of the consumer electronic device.

[0050] FIG. 5 is a high level site map of various screens and functions implemented by a consumer electronic device configured to receive and process therapy data obtained from an implantable therapy device according to various embodiments. The consumer electronic device is preferably a smartphone, phablet, or tablet configured to execute a mobile app. The mobile app causes a processor of the consumer electronic device to generate the screen images and perform the functions associated with the screens shown in FIG. 5-61. For purposes of illustration, but not limitation, the screens and associated processes shown in FIG. 5-61 are executed by a smartphone used by a patient. For purposes of illustration, but not limitation, the therapy data stored and processed within the patient's smartphone is therapy data obtained from a neurostimulation device. The neurostimulation device is configured to provide neurostimulation therapy to treat the patient's obstructive respiratory disorder. Other data, including patient-generated data (e.g., sleep log data) and physiological sensor data (e.g., snoring data) that provide insight into the patient's disease state (e.g., sleep apnea), are acquired and processed by the patient's smartphone.

[0051] Execution of the app is initiated by the patient tapping on the app icon displayed on the touch screen of the patient's smartphone. The patient is first presented with a Welcome screen 502, an example of which is shown in FIG. 6. From the Welcome screen 502, the patient can jump to a Learn More screen 540 shown in FIG. 7, a Create Account screen 505 shown in FIG. 9, or a Sign-in screen (similar to screen 505 in FIG. 9 but requiring an email address and password). If the patient needs to create a new account, it may be assumed that there is no treatment and related data for the patient in the smartphone. Thus, the patient is directed to a Get Started screen 506 shown in FIG. 10, after which the patient is directed to a Home screen 508. If the patient has an account, the patient is directed to the Sign-in screen. After signing in, the patient is presented with the Home screen 508, which is a default display of patient information for the current date (today). Different versions of the Home screen 508 are shown in FIG. 12-18. The differences in the home screen 508 are due to the availability or absence of different available data for presentation.

[0052] From the home screen 508, the patient can jump to different screens including History screens 510-516, Goals screens 520-528, Add Data screens 530-538, Learn More screens 540-542, More screens 550-556, and Programming screens 560-568. The History screens 510 (week), 512 (day), 514 (month), and 516 (year) display treatment data and other patient related data for the respective time periods. The Goals screens 520-528 include Goals Summary screen 520, Outcome Summary screen 522, and Goals / Outcome Analysis screens for different time periods including screens 524 (week), 526 (month), and 528 (year). The Add Data screens 530-538 include a Data Upload screen 532, a Sleep Notes screen 534, a Sleepiness Score screen 536, and a Start Snore Tracker screen 538. The Learn More screens include a Learn More screen 540 and a Learn More Topic screen 542. The More screens include a More screen 550, a Profile screen 552, a Reminder screen 554, and an Add Connected Apps screen 556.

[0053] The following description describes many of the screens shown in the site map of FIG. 5. For example, FIG. 6 shows a welcome screen 502, where the patient can jump to a learn more screen 540, an account creation screen 505, or a sign-in screen 504. FIG. 7 shows a learn more screen 540 that provides the patient with more information (e.g., detailed information and FAQs) about the app and the care provided to the patient. FIG. 8 shows a learn more topic screen 542, where the patient can enter a specific question into the app (e.g., How do I upload my data to the app?). The answer to the patient's question may be displayed as text only, text and image, video, or a combination of these outputs. The answer may include a link to one or more websites outside the app. FIG. 9 shows an account creation screen 505, where the patient can create an account using the patient's first name, last name, phone number, email address, and password.

[0054] FIG. 10 illustrates a start screen 506 that provides instructions to the patient for uploading data to the app. In the embodiment illustrated in FIG. 10, the start screen 506 instructs the patient to place the smartphone next to the patient remote (also referred to herein as the sleep remote). As previously described, the patient remote includes memory that stores therapy and physiological data acquired from the patient's implantable therapy device. Activation of an upload button (not shown) displayed on the smartphone screen initiates uploading of data from the patient remote to the patient's smartphone (e.g., via a radio frequency link). In one embodiment, and as previously described, the smartphone is configured to acquire therapy and physiological data directly from the implantable therapy device. In such an embodiment, one or more screens providing instructions for uploading data directly to the smartphone are displayed on the smartphone display. In any of these embodiments, the status of the upload process is displayed on an upload screen 532. For example, the patient receives a notification that data is being uploaded and a subsequent notification that the data upload was successful. It will be appreciated that when uploading data through the add data screen 530, upload screens similar to screens 506 and 532 are displayed.

[0055] 12 shows a home screen 508 that is a default display of data for today's date (e.g., May 4). The home screen 508 includes a graph icon 1202, which in this example displays the patient's therapy utilization data for May 4 as a stacked bar graph. The stacked bar graph 1202 is displayed in an open ring configuration. One end of the open ring graph 1202, shown as end A, defines the start of therapy utilization by the patient. The other end of the open ring graph 1202, shown as end B, defines the end of therapy defined by a target therapy duration established by a clinician. The entire period between ends A and B represents the target therapy duration established for the patient. In this example, the target therapy duration is 8 hours.

[0056] The stacked bar graph 1202 shows the duration of each of the different phases of therapy utilization in chronological order. The different phases include a start delay 1202a, a therapy on phase 1202b, a therapy off phase 1202c, and a therapy off phase 1202d. Each of the phases may be indicated by a different color or different hatching within the stacked bar graph 1202. The start delay 1202a is typically programmed by the patient's clinician, while the therapy on, off, and off phases 1202b, 1202c, 1202d are controlled by the patient (in response to patient input into a patient remote or patient controls displayed on a smartphone display). In the stacked bar graph 1202 shown in FIG. 12, it can be seen that after the start delay 1202a, a first therapy period 1202b is provided to the patient, followed by a first off period 1202c and a second therapy period 1202b. After the second treatment period 1202b, the patient began a second interruption period 1202c, followed by a third treatment period 1202b. The patient initiated a treatment off command to end treatment 1202d before reaching the target treatment period 1202f. Period 1202e shows the period between the treatment off phase 1202d and the target treatment period 1202f. In this example, the patient's treatment utilization on May 4 was 7.2 hours, the start delay 1202a was 18 minutes, and there were a total of two interruptions. This data 1204 is displayed as text in the center of the open ring stacked bar graph 1202.

[0057] The home screen 508 includes a top banner showing the day of the current week and an open ring stacked bar graph for each day of the current week. It will be appreciated that the patient can swipe left or right to select other days. Tapping the graph icon 1202 opens a history screen that defaults to a weekly view of patient utilization data and other related data (see, e.g., FIGS. 28-30). The home screen 508 may further include treatment utilization goals and / or outcomes 1212. Goals and outcomes serve to motivate and reward patient adherence to treatment.

[0058] The home screen 508 includes patient-generated data such as patient-entered sleep notes 1208 and a sleepiness score 1210. The sleep notes 1208 may be entered by the patient using a sleep notes screen 534 shown in FIG. 20. The patient may add notes for one or more days, and the notes may be entered by typing or speaking. With reference to FIG. 20, a calendar icon opens a date selected by the patient. The sleep notes screen 534 allows the patient to add, edit, and delete notes. As shown in FIGS. 14 and 15, the patient may edit and delete the sleep notes 1208 at a later date. The sleepiness score 1210 is calculated by the smartphone processor based on the patient's answers to a number of survey questions. In particular, and as shown in FIGS. 21 and 22, a clinical survey such as the Epworth sleepiness scale (ESS) questionnaire may be presented to the patient. The patient's answers to the survey questions form the basis of the sleepiness score 1210. As shown in Figures 15 and 16, the patient can edit and delete the sleepiness score 1210. It will be appreciated that the sleep notes 1208 and sleepiness score 1210 can be accessed (via buttons 1904 and 1906) through the add data screen 530 shown in Figure 19. The data screen 530 allows the patient to initiate a sync with the patient remote (via button 1902) and initiate the snore tracker (via button 1908).

[0059] Figure 13 shows a version of the home screen 508 with the same functionality and similar content as the home screen 508 shown in Figure 12. As well as displaying the therapy utilization bar graph 1202, the home screen 508 of Figure 13 further includes a therapy utilization summary 1304 that provides details regarding therapy on duration, start delay duration, and number of therapy interruption events. The home screen 508 of Figure 13 includes snoring data in both graph and summary form.

[0060] The snore data is shown as a stacked bar graph 1302 with an open ring arrangement similar to that of the treatment utilization bar graph 1202. The snore graph icon 1302 is disposed inside the treatment utilization graph icon 1202. The snore graph icon 1302 and the treatment utilization graph icon 1202 are chronologically (radially) aligned with each other. The snore bar graph 1302 displays the snore data as bars with different properties (color, hatching) and with a size corresponding to the magnitude (e.g., intensity or severity) of the snore data. For example, different colors or hatching patterns may be used to indicate different categories of snoring, such as quiet, mild, severe, loud snoring, etc. The smartphone processor can analyze the snore signal received from the microphone and can distinguish between different categories of snoring based on different amplitude thresholds associated with each snore category. A summary 1312 of the snore tracking data is displayed on the home screen 508. It will be appreciated that scrolling down on the home screen 508 exposes sleep notes 1208 and sleepiness score 1210.

[0061] In one embodiment, the stacked bar graph 1302 (inner ring of data) may represent any type of sensor data or disease burden data. For example, the inner ring of data 1302 may be disease burden data derived from any or a combination of Apnea Hypopnea Index (AHI), Oxygen Saturation (SpO2), Oxygen Desaturation Index (ODI), Snoring, Blood Glucose Levels, Heart Rate Variability, Blood Pressure, and Atrial Fibrillation (AF). The inner ring of data 1302 may be posture data (e.g., sleep position, e.g., left, right, prone, supine, by accelerometer). The inner ring 1302 of data may be sleep stage data derived from one or more or combinations of brain activity (electroencephalogram, EEG), muscle activity (e.g., electromyogram, EMG), mechanical heart activity (e.g., heart sounds, seismocardiogram, SCG), electrical heart activity (electrocardiogram, ECG), heart rate, heart rate variability, blood pressure, body temperature, and neural activity. Alternatively, posture and / or sleep state data may be located on top or in a third ring of data, or both. Additional sensor data and / or disease burden data may be represented as additional inner rings or multiple rings of data (e.g., a third inner ring of data, a fourth inner ring of data).

[0062] As previously described, the snore tracker may be activated by the patient using the button 1908 on the add data screen 530 shown in FIG. 19. Activation of the button 1908 causes the snore tracker screen 538 shown in FIGS. 23-25 ​​to be displayed on the smartphone display. The snore tracker screen 538 shown in FIG. 23 may provide short descriptions and tips that can be cycled through each time the snore tracker is selected. The snore tracker may be started by activation of the button 2302 by the patient. As shown in FIG. 24, the patient may stop, pause, or cancel the snore tracker by activation of buttons 2402, 2404, 2406, respectively. A graphical representation of the patient's snore data (e.g., in the form of a signal) may be displayed, as well as the time at which the snore tracker was started during the entire period of snore tracking. The snore tracker screen 538 shown in FIG. 25 includes a snore bar graph and a summary 1312 of snore data by severity category. The start time, end time, and total duration of snore tracking are also displayed. Button 2502 allows the patient to sync the patient remote with the smartphone to update the therapy data stored in the smartphone. Button 2504 allows the patient to jump to the sleep notes screen 534 shown in FIG. 20 to enter and edit sleep notes.

[0063] Although the home screen 508 shown in FIG. 13 includes snore data, other objective data indicative of the patient's disease status may be displayed in FIG. 13 instead of or in addition to the snore data. For example, the apnea-hypopnea index (AHI), oxygen saturation data (SpCh), and / or oxygen desaturation data index (ODI) may be calculated / obtained (e.g., from an implantable therapeutic device and / or from one or more physiological sensors), monitored, and displayed on the home screen 508. Obstructive and central apnea events may be detected (e.g., by an implantable therapeutic device), monitored, and displayed on the home screen 508. These objective data may be displayed near the therapy utilization data so that visual correlations between disease status events and / or trends and the therapy utilization data can be found. Disease status information over time may also be displayed separately on the home screen 530 or on other screens. Additionally, disease status information may be displayed as a heat map (e.g., warm colors for areas of greater severity and cool colors for areas of lesser severity). Disease status information may be correlated to other sensor information in addition to or instead of therapy utilization data. For example, disease status information may be displayed along with posture data (supine, prone, left, right) sensed by the smartphone's accelerometer. Disease status information may be displayed along with sleep state information, such as REM and non-REM sleep state data. Sources of objective data displayed in FIG. 13 may include a variety of sources (e.g., Bluetooth, ZigBee, ODI, snoring, other external sleep sensors, sensors with embedded systems).

[0064] FIG. 17 shows a version of the home screen 508 with no data uploaded for the current day (today). The last upload date is displayed on the home screen 508. The center area of ​​the home screen 508 is changed to an activation button 1702, which, when activated by the patient, causes the upload screen 532 of FIGS. 10 and 11 to be displayed. Following the instructions on the upload screen 532, therapy data may be sent from the patient remote or implantable therapy device to the smartphone. Button 1702 allows the patient to add sleep notes through a sleep notes screen 534 shown in FIG. 20. Button 1704 allows the patient to add a sleepiness score through a sleepiness score screen shown in FIGS. 21-22. FIG. 18 is an example of the home screen 508 when therapy data for the current day (today) is not available, but snoring data and patient generated data (sleep notes and sleepiness score) are available.

[0065] The goals screen 520 is shown in FIG. 26. The goals screen 520 includes a "Therapy Utilization" goal 2602, a "Sync with Patient Remote" goal 2604, and a "Constant Bedtime" goal 2606. Each goal 2602, 2604, 2606 includes a graphical indicator that shows the current progress toward each goal. The outcomes screen 522 is shown in FIG. 27. The outcomes screen 522 includes a "Therapy Utilization" outcome 2702, a "Quietest Night" outcome, and a "Sync with Patient Remote" outcome 2706.

[0066] 28 and 29 show the history screen 510, which is a weekly view showing daily data, averages, and outcomes. The patient can select a specific date range by selecting the calendar icon. Selecting the calendar with a checkmark icon returns the patient to the data for the current day (today). Therapy utilization data 2802 is displayed as a stacked bar graph for each day of the week. The number and percentage of nights during the week on which therapy was utilized are displayed. The average number of hours on which therapy was utilized and the average number of interruption events are displayed, respectively. Stimulation amplitude data 2804 is displayed as a bar graph for each day of the week. The pre-defined amplitude range established by the clinician is also displayed. Scrolling down the history screen 510 displays the patient's sleepiness score 2806 for each day of the week. The patient's outcomes 2808 and sleep notes 2810 are also displayed. Snoring tracking data 3002, shown in FIG. 30, is also displayed on the history screen 510, for example, after the amplitude portion 2804. Snoring tracking data 3002 is displayed as a stacked bar graph for each day of the week.

[0067] 31 and 32 show a history screen 510, which is a day view showing more detailed information regarding therapy utilization 3102, amplitude 314, and snore tracking 3104. The day view defaults to the current day (today) but may be selected by the patient using a calendar icon. Therapy utilization data 3102 provides a graphical display (stacked bar graph) showing the time and duration of therapy on, therapy off, and therapy off phases. Amplitude data 3104 includes input, final, and patient control range data. Snoring tracking data 3106 includes a snore severity line chart displayed as a function of time during the night. Sleep notes 3108 are also displayed.

[0068] FIG. 33A illustrates an embodiment of a More screen 550. The More screen 550 provides links to various settings and controls. For example, to view and edit profile information, a Profile screen 552 can be accessed by button 3302. An exemplary example of a Profile screen 552 is shown in FIG. 34. To view and edit reminders, a Reminders screen 554 can be accessed by button 3304. An exemplary example of a Reminders screen 554 is shown in FIG. 39. To add and edit connected apps, a Connected Apps screen 556 can be accessed by button 3306. An exemplary example of a Connected Apps screen 556 may include an App Settings screen 557 shown in FIG. 38.

[0069] Figure 33B illustrates another embodiment of a More screen 550. The More screen 550 illustrated in Figure 33B includes a Profile screen 552 accessible via button 3312 to view and edit profile information (see, e.g., Figure 34). A Medical Information screen 553 is accessible via button 3314 to view and edit the patient's medical information. An exemplary medical information screen 553 is shown in Figure 35. In this exemplary example, the medical information accessible via the Medical Information screen 553 may include the patient's physician information (e.g., name, hospital / office, phone number, email address) and the patient's health insurance information.

[0070] A Share screen 555 can be accessed by button 3316 to view and edit information (e.g., name, email address, text number) of interested parties (doctors, clinicians, caregivers, relatives / friends) and / or entities with whom medical and other data may be shared. A representative example of a Share screen 555 is shown in FIG. 36. Generally, the Share screen 555 allows a patient to share treatment and other medical information with others (individuals and / or entities) via their smartphone. The Share screen 555 allows a patient to view patient treatment data from a remote source via a connection established by the patient with a connection request. The source of the shared treatment / medical and other data may be the patient's smartphone and / or a remote server in communication with the patient's smartphone and / or another source (e.g., a medical clinic's server).

[0071] An app settings screen 557 can be accessed by button 3318 to view and edit settings for one or more apps (e.g., connected apps) executable by the patient's smartphone. An exemplary example of the app settings screen 557 is shown in FIG. 38. The app settings screen 557 may be used to set up automatic app updates for the patient's smartphone, initiate manual app updates, and / or select different ways of displaying data to the patient on the smartphone display (e.g., basic or complex displays). A patient remote screen 559 can be accessed by button 3320 to view and edit settings for communicating with and / or controlling a patient remote configured to communicate with and / or program medical devices (e.g., implantable therapeutic devices). A reminders screen 554 can be accessed by button 3322 to view and edit reminders. In the exemplary example shown in FIG. 39, active reminders can be set, such as a morning survey reminder and an evening survey reminder. Enabling the morning survey reminder and the evening reminder may cause the mobile app to display the morning check-in and evening check-in screens 4302, 4402 shown in Figures 43 and 44. Disabled reminders may also be set, such as appointment reminders and sleep hygiene tip reminders.

[0072] 40-61 show representative screens and functions associated with a sleep logging function implemented by a consumer electronic device according to various embodiments. The sleep logging function provides for collection of sleep-related information entered by the patient and / or automatically obtained by a mobile app executed by the consumer electronic device. For example, the sleep logging data may be entered manually by the patient using the various screens shown in FIG. 40-61. For example, the patient subjective sleep logging data may be entered using a touch keyboard or verbal input. Additionally or alternatively, some of the sleep logging data (e.g., patient objective sleep memory data) may be collected automatically from the mobile app, for example, by detecting usage patterns (e.g., the patient's smartphone usage before going to sleep and after waking up) along with environmental sensors, such as ambient light (e.g., by an ambient light sensor on the smartphone), motion (e.g., by an accelerometer or gyro on the smartphone), and sound sensors (e.g., by a microphone on the smartphone). The sleep logging function implemented in a mobile app executed on the patient's consumer electronic device may additionally provide sleep hygiene tips and educational content to the patient.

[0073] As shown in FIG. 5, the sleep logging function may be performed by the patient's smartphone using a sleep logging screen 537. Through the sleep logging screen 537, the patient may initiate the sleep logging function using the exemplary screens shown in FIGS. 40-56. These screens allow the patient to enter various types of sleep logging information and receive sleep hygiene tips. The patient may receive therapy and device education through a therapy and device education screen 539. Activating the therapy and device education screen 539 displays a screen that provides educational information about the therapies that can be delivered to the patient, the therapy devices implanted within the patient, and how to track details about the patient's sleep. Exemplary education screens are shown in FIGS. 57-61.

[0074] FIG. 40 illustrates a screen 4002 that may be displayed to a patient in response to activating the sleep logging / sleep hygiene tips screen 537 illustrated in FIG. 5. The screen 4002 includes a button that allows the patient to begin entering sleep details for the current day. The screen 4002 may provide guidance to the patient to understand how to use the mobile app to perform the sleep logging function. The guidance provided by the mobile app may include displaying the screen 4102 illustrated in FIG. 41. The screen 4102 provides information on how to track the patient's sleep details. For example, information may be displayed graphically and / or textually on how the patient may enter sleep data regarding morning details, evening details, sleep symptoms, energy levels, etc.

[0075] FIG. 42 shows a variation of the screen 4002 shown in FIG. 40. The screen 4202 shown in FIG. 42 includes buttons that allow the patient to begin inputting sleep details for the current day and that allow the patient to activate the bedtime monitor. The bedtime monitor provides for a mobile app to monitor the patient's sleep environment. For example, a bedtime monitor implemented by a mobile app provides for environmental sensors on the patient's smartphone to monitor ambient light, ambient sound, and phone usage. As previously mentioned, these environmental sensors may include an ambient sensor, an accelerometer or gyro, and the smartphone's microphone.

[0076] 43 shows a morning check-in screen 4302, which may be activated manually by the patient or automatically with an enabled reminder. Along with other information, the morning check-in screen 4302 allows the patient to input their energy level in the morning (e.g., sleepy, normal, refreshed) by activation of the appropriate button. The morning check-in information obtained through screen 4302 provides insight into the quality of the previous night's sleep.

[0077] 44 shows an evening check-in screen 4402 that may be activated manually by the patient or automatically with an enabled reminder. Along with other information, the evening check-in screen 4402 allows the patient to enter details about the current day that may affect the quality of their sleep the coming night. For example, the mobile app may display text and / or graphics to allow the patient to enter times when they drank caffeine, alcohol, and ate heavy meals that may negatively affect the patient's quality of sleep the coming night.

[0078] Figures 45-47 show screens that allow the patient to enter sleep log information for each day of the week. Screen 4502 shown in Figure 45 allows the patient to enter bedtime information such as the time they went to bed, the time they woke up, and the time they went to sleep. Screen 4602 shown in Figure 46 allows the patient to enter their energy level after the previous night's sleep. Screen 4702 shown in Figure 47 allows the patient to enter information about what they ate in the two to three hours before going to bed. For example, the patient can enter whether they drank alcohol or ate a large meal or other food (e.g., chocolate) shortly before going to bed.

[0079] Figures 48-49 show screens summarizing the patient's sleep record details for a particular day. Screen 4802 shown in Figure 48 shows the total duration of sleep, the patient's energy level following the previous night's sleep, the time the patient was in bed, the time they woke up, the time they fell asleep, and any sleep disorders (e.g., snoring, snoring). Screen 4902 shown in Figure 49 is a continuation of screen 4802 shown in Figure 48. Screen 4902 summarizes the patient's caffeine intake, amount of exercise, food and drink intake before bed, medications or vitamins, and the patient's activities in the hour before bed (e.g., reading a book, watching TV).

[0080] Figures 50-52 show screens that display additional sleep details to the patient. Screen 5002 shown in Figure 50 shows the patient's performance in addition to total sleep and energy level. For example, the patient's performance may be displayed as a current streak, such as the number of consecutive days the patient has tracked their sleep and the number of consecutive days the patient has exercised. Displaying the patient's performance information provides motivation for improved patient sleep habits. Figures 51 and 52 display sleep hygiene tips in addition to the total sleep and energy level information. The sleep hygiene tips provide information about the patient's sleep environment that can significantly improve the patient's sleep quality. The sleep hygiene tips may provide information about the quietness and comfort of the bedroom, the bedroom temperature, and the level of ambient light in the bedroom.

[0081] Screen 5302 shown in FIG. 53 provides a monthly calendar view of the patient's sleep details. As shown, a chart showing the patient's total sleep time and energy levels is displayed for each day of the month. Additional sleep details are provided by clicking on any day of the month. Screen 5402 shown in FIG. 54 includes the number of days in the month for which no sleep log information has been entered. The mobile app may be programmed to remind the patient to enter sleep log information after a certain number of days (e.g., 1, 2, or 3) without sleep log information. In the example shown in FIG. 54, screen 5402 displays a reminder to the patient that it has been three days since sleep log data was entered.

[0082] 55 and 56 show screens that present outcome information to the patient. Screens 5502 and 5602 shown in FIGS. 55 and 56 allow the patient to view current and all streaks and outcomes. For example, streaks may include the number of consecutive days the patient has entered sleep log information and participated in exercise. Outcomes may include the percentage of sleep goals achieved, the number of days sleep has been logged by the patient, and the number of days a predefined sleep goal has been achieved.

[0083] 57-61 show screens that provide various types of educational information to the patient in response to activating the Therapeutic and Device Education screen 539 shown in FIG. 5. Screen 5702 shown in FIG. 57 allows the patient to view a care guide for the therapeutic device, information on how the therapy works, and information on how to improve their sleep. Screen 5802 in FIG. 58 shows details of the care guide, which includes information on how to use the Patient Remote and adjust the therapeutic device and / or therapy provided by the device, and provides answers to frequently asked questions, among other information. Screen 5902 shown in FIG. 59 shows information regarding care and healing after implantation of the therapeutic device, and can be activated by a button displayed on screen 5802 in FIG. 58.

[0084] Screen 6002 shown in FIG. 60 provides detailed information to the patient regarding how the treatment provided by the treatment device works and proven results. Screen 6002 also provides insurance information, answers to frequently asked questions, and information on how to contact a physician (e.g., the patient's physician or a physician knowledgeable about the treatment device). Screen 6102 shown in FIG. 61 provides additional details regarding how the treatment works and can be activated by a corresponding button displayed on screen 6002 of FIG. 60.

[0085] FIG. 62 illustrates a medical system / device that may be used to generate patient medical data that can be uploaded to a remote server, according to various embodiments. FIG. 62 illustrates a wireless programmer 6202 configured to communicate with a patient medical device 6205 via a telemetry cable 6250. According to various embodiments, the wireless programmer 6202 may be implemented as a tablet computer or other portable computing device (e.g., a phablet, notebook, or laptop). The wireless programmer 6204 is configured to implement an application (app) or browser that facilitates the clinician's interaction with the telemetry cable 6250 and the patient medical device 6205. In one embodiment, the patient medical device 6205 is a neurostimulator device configured to provide neurostimulation therapy to treat the patient's obstructive respiratory disorder. In such an embodiment, the neurostimulator device 6205 includes a neurostimulator and a stimulation lead that extends from a housing of the neurostimulator to the hypoglossal nerve in the patient's neck. A sensing lead extends from the housing of the neurostimulator and is implanted in the rib cage at the level of the intercostal muscles. The sensing leads detect movement of the intercostal muscles during the patient's respiration, and signals therefrom are used to detect the patient's respiration. A pulse generator within the neurostimulator provides electrical stimulation to the hypoglossal nerve through the stimulation leads based on the detected patient's respiration.

[0086] The wireless programmer 6202 may be used by a clinician to interrogate and adjust various parameters of the patient medical device 6205 (referred to as "programming"), monitor the therapy provided by the patient medical device 6205, and monitor patient compliance with prescribed therapy. Figure 62 illustrates a wireless patient remote configured to facilitate adjustment of one or more therapy settings of the patient medical device 6205 directly by the patient.

[0087] The telemetry cable 6250 communicates wirelessly with the patient medical device 6205 and facilitates wireless communication between the patient medical device 6205 and the wireless programmer 6202. The wireless programmer 6202 includes a display 6204 and a stylus 6206 to allow a clinician to interact with the display 6204, for example, by entering, editing, and reviewing data. In an embodiment, the display 6204 may be configured as a touch screen, in which case the stylus 6206 may be omitted or may be an optional accessory. The wireless programmer 6206 includes multiple interfaces, buttons, and controls, some of which are shown in the exemplary embodiment of FIG. 62. A power button 6210 is provided on the top right edge of the housing 6201 and a cluster of controls 6230 is provided on the top right portion of the front of the housing 6202. The control cluster 6230 includes multi-position controls 6232 to allow the clinician to interact with the processor 6207 and display 6204 of the programmer 6202 in a variety of ways. The processor 6207 of the programmer 6202 may be programmed to implement the various methods and functions described herein. Additional buttons 6234 may be located proximate (or remote from) the control cluster 6230. The wireless programmer 6202 includes several different interfaces / elements including a power connector plus USB port 6218, a network cable, and a USB port 6220. The interfaces and elements described above are described by way of example and not by way of limitation.

[0088] The telemetry cable 6250 is configured to wirelessly communicate with both the wireless programmer 6202 and the patient medical device 6205. The telemetry cable 6250 effectively functions as a wireless bridge or modem between the programmer 6202 and the patient medical device 6205. In accordance with the embodiment shown in FIG. 62, the telemetry cable 6250 includes a telemetry head 6252 configured to wirelessly communicate with the patient medical device 6205 by a near-field link. The telemetry head 6252 is shown to include a status indicator 6253, e.g., an LED indicator. In one embodiment, the telemetry head 6252 is configured to inductively communicate with the patient medical device 6205 by a near-field link.

[0089] A cable 6254 extends from the telemetry head 6252 and is connected to a wireless transceiver 6260. The wireless transceiver 6260 may be configured for short-range wireless radio frequency (RF) communication. For example, the wireless transceiver 6260 may be configured to implement a short-range RF communication link, such as by implementing a Bluetooth® or ZigBee® communication protocol. In an embodiment, the wireless transceiver 6260 may be configured to wirelessly communicate with an existing network infrastructure by a suitable RF communication protocol, such as Wifi®. The wireless transceiver 6260 is shown to include a status indicator 6262. Power is provided to the telemetry cable 6250 by a power supply 6270. The power supply 6270 is shown to include a power cable 6272 terminated by a standard AC wall plug 6274. The power supply 6270 provides power to both the wireless transceiver 6260 and the telemetry head 6252.

[0090] The patient remote 6280 (Patient Remote) is shown to include buttons that allow the patient to modify the therapy parameters, status indicators of the implantable device status (e.g., remote and implantable device communication status and implantable device battery status), and remote status (remote battery status). The patient remote 6280 is used by the patient during home therapy applications to make necessary adjustments to therapy parameters (e.g., stimulation amplitude) if necessary or desired. The patient remote 6280 shown in FIG. 62 has a control panel 6281 that includes a number of control buttons that can be actuated by a user. The control buttons provided on the control panel 6281 allow the patient to turn therapy on and off, pause therapy, and adjust one or more parameters that affect the operation of the implantable medical device surgically implanted within the patient. For example, the control panel 6281 may include a therapy on button and a therapy off button, each of which may be actuated by the patient to turn stimulation therapy on and off. An increase control provided on the control panel 6281 allows the patient to increase stimulation intensity within a range selected by the clinician. A decrement control provided on the control panel 6281 allows the patient to decrement the stimulation intensity within a range preselected by the clinician.

[0091] The wireless programmer 6202, patient remote 6280, and patient medical device 6205 (e.g., neurostimulator) may be implemented according to co-pending U.S. Patent No. 9,839,786 (Londoni et al.) and U.S. Patent Application Publication No. 2016 / 0193468 (Londoni et al.), each of which is incorporated by reference herein.

[0092] In this disclosure, various processors are referenced. The processors disclosed herein may be single processors or multiple processors. The processor may be implemented as one or more multi-core processors, digital signal processors (DSPs), microprocessors, programmable controllers, general purpose computers, special purpose computers, hardware controllers, software controllers, combination hardware and software devices, such as programmable logic controllers, programmable logic devices (e.g., FPGAs, ASICs), personal digital assistants such as personal computers (PCs), mainframe computers, laptops, notebooks, tablets, phablets, or smartphones. The processor may include or be coupled to memory, such as RAM, SRAM, ROM, flash, SSD (solid state drive) or hard drive (HDD). The processor may be an element of a computer or communication device that cooperates with a communication interface (e.g., wired or wireless interface), a display (e.g., touch screen), memory (RAM, ROM, flash, SSD, hard drive), and a user interface (e.g., keyboard, mouse, voice control interface, touch screen). The processor may include or be coupled to one or more communications interfaces, e.g., wired and / or wireless interfaces (e.g., USB, Firewire, Lightning, GSM, CDMA, GPRS, HSDPA, Bluetooth, ZigBee, IEEE 802.11, ISO / IEEE 11073 compliant interfaces). The processor of the present disclosure may be programmed to execute program instructions or code (e.g., software, firmware) such that the processor performs the processes disclosed herein, e.g., described with reference to the Figures.

[0093] This document discloses several embodiments, including but not limited to the following:

[0094] Item 1 is a method, Establishing communication between a therapeutic device implantable within a patient and a consumer electronic device operable by the patient; controlling, by the consumer electronic device, a predefined set of therapeutic device functions in response to patient input to the consumer electronic device; and displaying the treatment data on a display of the consumer electronic device.

[0095] Item 2 is the method of item 1, wherein the predefined set of therapeutic device functions includes turning on the therapeutic device, turning off the therapeutic device, and discontinuing therapy delivery by the therapeutic device.

[0096] Item 3 is the method of item 1, wherein the predetermined set of treatment device functions includes adjusting an amplitude of treatment provided by the treatment device.

[0097] Item 4 is the method of item 1, wherein the treatment data comprises treatment utilization data.

[0098] Item 5 is the method of item 4, wherein the therapy utilization data includes a start delay and data indicating dates and times when therapy was provided, therapy was interrupted, and therapy was turned off in response to patient input into the consumer electrical device.

[0099] Item 6 is the method of item 1, wherein the therapy data comprises data indicative of therapy settings programmed into the therapy device.

[0100] Item 7 is the method of item 1, wherein the therapy data comprises a consumer electronic device and data indicative of therapy settings programmed into the therapy device by a clinician programmer.

[0101] Item 8 is that treatment data is a predefined range of treatment amplitudes programmed into the treatment device by a clinician; and a patient-selected treatment amplitude programmed into the treatment device by the patient.

[0102] Item 9 is the method of item 8, including displaying on the display a predefined range of treatment amplitudes and a patient-selected treatment amplitude.

[0103] Item 10 is transmitting physiological data obtained from one or more sensors coupled to or located near the patient to a consumer electrical device; and displaying the therapy data and the physiological data on the display.

[0104] Item 11 is transmitting the diagnostic data obtained from the treatment device to a consumer electronic device; and displaying the therapeutic and diagnostic data on the display.

[0105] Item 12 is the treatment data comprises treatment utilization data and a target treatment duration; Item 1. The method of item 1, wherein displaying the treatment data includes displaying the treatment utilization data and the target treatment duration on the display as a stacked bar graph, as a chart.

[0106] Item 13 is the method of item 12, in which the stacked bar graph has an open ring configuration.

[0107] Item 14 is The treatment data includes treatment utilization data and a target treatment duration; The therapy utilization data includes a start delay and data indicating dates and times when therapy was provided, therapy was interrupted, and therapy was turned off in response to patient input into the consumer electrical device; Item 2. The method of item 1, wherein displaying the therapy data includes displaying on the display as a stacked bar graph the target therapy duration and, in a chronological order and in proportion to the duration, start delays, therapy provided, therapy interrupted, and therapy turned off.

[0108] Item 15 is the method of item 14, in which the stacked bar graph has an open ring configuration.

[0109] Item 16 is the method of any of items 12-15, in which treatment data is displayed for a selected day or for each day of a selected number of days.

[0110] Item 17 is transmitting physiological data obtained from one or more sensors coupled to or positioned near the patient to a consumer electrical device; and displaying the physiological data on the display and in chronological alignment with the therapy utilization data as a stacked bar graph having an open ring configuration positioned inside or outside the therapy utilization data; Item 16. The method of item 15, wherein the physiological data is displayed as a bar having a size proportional to the magnitude of the physiological data.

[0111] Item 18 is The treatment device has a neurostimulator configured to provide a neurostimulator for treating obstructive respiratory disorders; Item 18. The method of item 17, wherein the physiological data comprises snoring data.

[0112] Item 19 is the method of item 18, wherein the sensor configured to generate snoring data comprises a microphone of the consumer electrical device.

[0113] Item 20 is the method of item 18, in which the snoring data is displayed as bars corresponding to quiet, light, heavy, and loud snoring.

[0114] Item 21 is the method of any of Items 17-20, in which therapy data and physiological data are displayed for a selected day or for each day of a selected number of days.

[0115] Item 22 is the method of any of Items 1-16, wherein the treatment device includes a neurostimulator configured to provide neurostimulation therapy for treating obstructive disordered breathing.

[0116] Item 23 is generating patient subjective information in response to patient input into a consumer electronic device; and displaying the patient-subjective information on the display.

[0117] Item 24 is the method of Item 23, wherein the patient subjective information comprises a score calculated by the consumer electronic device in response to the patient's responses to the medical questionnaire.

[0118] Item 25 is the method of item 1, comprising transmitting the therapy data from the consumer electronic device to a remote server.

[0119] Item 26 is transmitting treatment data for a particular patient from the remote server to a clinician processor; and displaying the treatment data on a display coupled to the clinician processor.

[0120] Item 27 is the method of item 1, wherein the consumer electronic device comprises a personal computer, a laptop, a notebook, a tablet, a personal digital assistant, a mobile phone, or a smartphone.

[0121] Item 28 is Establishing communication between a therapeutic device implantable within a patient and a patient remote operable by the patient; controlling, by the patient remote, a predefined set of therapy device functions in response to patient input to the patient remote; transmitting the therapy data from the therapy device to a patient remote; transmitting the therapy data from the patient remote to a consumer electronic device; and displaying the treatment data on a display of the consumer electronic device.

[0122] Item 29 is the method of item 28, wherein the therapy data is transmitted from the patient remote to the consumer electronic device as an ultrasound signal that is received by a microphone of the consumer electronic device.

[0123] Item 30 is the method of item 28, wherein the therapy data is transmitted from the patient remote to the consumer electronics device as an audible signal that is received by a microphone of the consumer electronics device.

[0124] Item 31 is the method of Item 28 comprising one or both of the processes and apparatus described in any of Items 2-27.

[0125] Item 32 is a therapeutic device implantable within the patient; a consumer electrical device operable by the patient; the consumer electrical device is configured to control a predefined set of therapeutic device functions in response to patient input to the consumer electrical device; The consumer electrical device further comprises: Receive therapy data transmitted from the therapy device; A system configured to display treatment data on a display of a consumer electronic device.

[0126] Item 33 is the system of Item 32, wherein the predefined set of therapy device functions includes turning on the therapy device, turning off the therapy device, and interrupting therapy delivery by the therapy device.

[0127] Item 34 is the system of item 32, wherein the predefined set of treatment device functions includes adjusting an amplitude of treatment provided by the treatment device.

[0128] Item 35 is the system of Item 32, wherein the treatment data comprises treatment utilization data.

[0129] Item 36 is the system of item 35, wherein the therapy utilization data includes a start delay and data indicating dates and times when therapy was provided, therapy was interrupted, and therapy was turned off in response to patient input into the consumer electrical device.

[0130] Item 37 is the system of Item 32, wherein the treatment data comprises data indicative of treatment settings programmed into the treatment device.

[0131] Item 38 is the system of Item 32, wherein the therapy data comprises a consumer electronic device and data indicative of therapy settings programmed into the therapy device by a clinician programmer.

[0132] Item 39 is for treatment data. a predefined range of treatment amplitudes programmed into the treatment device by a clinician; and a patient-selected treatment amplitude programmed into the treatment device by the patient.

[0133] Item 40 is the system of item 39 including displaying on the display a preset range of treatment amplitudes and a patient selected treatment amplitude.

[0134] Item 41 provides that a consumer electrical device: receiving physiological data obtained from one or more sensors coupled to or positioned near the patient; Item 32. The system of item 32 configured to display the therapy data and the physiological data on the display.

[0135] Item 42 provides that a consumer electrical device: receiving diagnostic data obtained from the treatment device; Item 32. The system of item 32 configured to display therapeutic and diagnostic data on the display.

[0136] Item 43 is the treatment data comprises treatment utilization data and a target treatment duration; Item 33. The system of item 32, wherein the consumer electronic device is configured to display the treatment utilization data and the target treatment duration as a stacked bar graph and as a diagram on the display.

[0137] Item 44 is the system of Item 43 in which the stacked bar graph has an open ring configuration.

[0138] Item 45 is The treatment data includes treatment utilization data and a target treatment duration; The therapy utilization data includes a start delay and data indicating dates and times when therapy was provided, therapy was interrupted, and therapy was turned off in response to patient input into the consumer electrical device; Item 33. The system of item 32, wherein the consumer electrical device is configured to display on the display the target treatment duration and, in a time series and in proportion to the duration, the start delay, the treatment provided, the treatment interrupted, and the treatment turned off as a stacked bar graph.

[0139] Item 46 is the system of item 45 in which the stacked bar chart has an open ring configuration.

[0140] Item 47 is a system of any of Items 43-46 in which treatment data is displayed for a selected day or for each day of a selected number of days.

[0141] Item 48 provides that a consumer electrical device: receiving physiological data obtained from one or more sensors coupled to or positioned near the patient; configured to display the physiological data on the display and in chronological alignment with the therapy utilization data as a stacked bar graph having an open ring configuration positioned inside or outside the therapy utilization data; The physiological data is displayed as a bar having a size proportional to the magnitude of the physiological data, system of item 45.

[0142] Item 49 is The treatment device has a neurostimulator configured to provide a neurostimulator for treating obstructive respiratory disorders; Item 48 is the system of item 48, wherein the physiological data comprises snoring data.

[0143] Item 50 is the system of item 49, wherein the sensor configured to generate snoring data comprises a microphone of the consumer electrical device.

[0144] Item 51 is the system of Item 49 in which snoring data is displayed as bars corresponding to quiet, light, heavy, and loud snoring.

[0145] Item 52 is any of the systems of items 48-51 in which the therapy data and physiological data are displayed for a selected day or for each day of a selected number of days.

[0146] Item 53 is the system of any of Items 32-47, wherein the treatment device includes a neurostimulator configured to provide neurostimulation therapy for treating obstructive respiratory disorder.

[0147] Item 54 is a consumer electrical device that: generating patient subjective information in response to patient input to the consumer electronic device; Item 33. The system of item 32, configured to display the patient subjective information on the display.

[0148] Item 55 is the system of Item 54, in which the patient subjective information comprises a score calculated by the consumer electronic device in response to the patient's responses to a medical questionnaire.

[0149] Item 56 is the system of Item 32, wherein the consumer electrical device is configured to transmit the treatment data to a remote server.

[0150] Item 57 specifies that the remote server: configured to transmit treatment data for a particular patient from the remote server to a clinician processor; The system of item 56, wherein the clinician processor is configured to display the treatment data on a display coupled to the clinician processor.

[0151] Item 58 is the system of Item 32, wherein the consumer electronic device comprises a personal computer, a laptop, a notebook, a tablet, a personal digital assistant, a mobile phone, or a smartphone.

[0152] Item 59 is Establishing communication between a therapeutic device implantable within a patient and a consumer electronic device operable by the patient; controlling, by the consumer electronic device, a predefined set of therapeutic device functions in response to patient input to the consumer electronic device; transmitting the therapy data from the therapy device to a consumer electronic device; generating patient subjective information in response to a patient input to a consumer electronic device; and displaying one or both of the treatment data and the patient subjective information on the display.

[0153] Item 60 is The patient subjective information includes sleep record information, Item 59. The method of item 59, wherein the sleep log information is entered into a consumer electronic device by the patient.

[0154] Item 61 is Establishing communication between a therapeutic device implantable within a patient and a consumer electronic device operable by the patient; controlling, by the consumer electronic device, a predefined set of therapeutic device functions in response to patient input to the consumer electronic device; transmitting the therapy data from the therapy device to a consumer electronic device; acquiring patient objective sleep record data automatically using one or more environmental sensors of a consumer electronic device; and displaying one or both of the therapy data and the patient objective sleep record data on the display.

[0155] Item 62 is a therapeutic device implantable within the patient; a consumer electrical device operable by the patient; the consumer electrical device is configured to control a predefined set of therapeutic device functions in response to patient input to the consumer electrical device; The consumer electronic device further comprises: Receive therapy data transmitted from the therapy device; generating patient subjective information in response to patient input to the consumer electronic device; A system configured to display one or both of therapy data and patient subjective information on a display of a consumer electronic device.

[0156] Item 63 is The patient subjective information includes sleep record information, Item 63. The system of item 62, wherein the sleep record information is entered by the patient into a consumer electronic device.

[0157] Although specific embodiments have been illustrated and described herein, those skilled in the art will recognize that various different and / or equivalent embodiments may be substituted for the specific embodiments illustrated and described without departing from the scope of the present disclosure. The present application is intended to cover any modifications or variations of the embodiments of the nature described herein. It is therefore intended that the specification be limited only by the claims and the equivalents thereto.

Claims

1. Establishing communication between a therapeutic device implantable within a patient and a consumer electronic device operable by the patient; controlling, by the consumer electronic device, a predefined set of therapeutic device functions in response to patient input to the consumer electronic device; transmitting therapy data from said therapy device to said consumer electronic device; displaying the treatment data on a display of the consumer electronic device; The method comprising:

2. The method of claim 1 , wherein the predefined set of therapeutic device functions comprises turning on the therapeutic device, turning off the therapeutic device, and discontinuing therapy delivery by the therapeutic device.

3. The method of claim 1 , wherein the predetermined set of therapeutic device functions comprises adjusting an amplitude of therapy provided by the therapeutic device.

4. The method of claim 1 , wherein the therapy data comprises therapy utilization data.

5. 5. The method of claim 4, wherein the therapy utilization data comprises start delay and data indicating dates and times when therapy was provided, therapy was interrupted, and therapy was turned off in response to patient input into the consumer electrical device.

6. 10. The method of claim 1, wherein the therapy data comprises data indicative of therapy settings programmed into the therapy device by the consumer electronic device and a clinician programmer.

7. The treatment data comprises: a predefined range of treatment amplitudes programmed into the treatment device by a clinician; a patient-selected treatment amplitude programmed into said treatment device by a patient; 7. The method of claim 6, comprising:

8. 8. The method of claim 7, comprising displaying on the display the predefined range of treatment amplitudes and the patient-selected treatment amplitude.

9. transmitting physiological data obtained from one or more sensors coupled to or located near a patient to the consumer electrical device; displaying the therapy data and the physiological data on the display; 2. The method of claim 1, comprising:

10. transmitting diagnostic data obtained from the treatment device to the consumer electronics device; displaying the therapeutic data and the diagnostic data on the display; 2. The method of claim 1, comprising:

11. the treatment data includes treatment utilization data and a target treatment duration; 10. The method of claim 1, wherein displaying the therapy data comprises displaying the therapy utilization data and the target therapy duration as a stacked bar graph or as a chart on the display.

12. The method of claim 11 , wherein the stacked bar graph has an open ring configuration.

13. the treatment data includes treatment utilization data and a target treatment duration; the therapy utilization data includes a start delay and data indicative of dates and times when therapy was provided, therapy was interrupted, and therapy was turned off in response to patient input into the consumer electrical device; 2. The method of claim 1, wherein displaying the therapy data comprises displaying on the display as a stacked bar graph the target therapy duration and, in a chronological order and in proportion to the duration, start delays, delivered therapy, discontinued therapy, and turned off therapy.

14. The method of claim 13 , wherein the stacked bar graph has an open ring configuration.

15. transmitting physiological data obtained from one or more sensors coupled to or located near a patient to said consumer electrical device; displaying the physiological data on the display and in chronological alignment with the therapy utilization data as a stacked bar graph having an open ring configuration positioned inside or outside the therapy utilization data; having The method of claim 13 , wherein the physiological data is displayed as a bar having a size proportional to the magnitude of the physiological data.

16. the therapeutic device comprising a neurostimulator configured to provide a neurostimulator for treating an obstructive respiratory disorder; The method of claim 15 , wherein the physiological data comprises snoring data.

17. The method of claim 16 , wherein the sensor configured to generate snoring data comprises a microphone of the consumer electrical device.

18. The method of claim 17, wherein the snoring data is displayed as bars corresponding to quiet, light, heavy, and loud snoring.

19. The method of claim 1 , wherein the therapeutic device comprises a neural stimulator configured to provide neural stimulation therapy for treating obstructive respiratory disorder.

20. generating patient subjective information in response to a patient input to said consumer electronic device; displaying the patient subjective information on the display; 2. The method of claim 1, comprising:

21. 21. The method of claim 20, wherein the patient subjective information comprises a score calculated by the consumer electronics device in response to a patient's responses to a medical questionnaire.

22. The patient subjective information includes sleep record information, 21. The method of claim 20, wherein the sleep log information is entered into the consumer electronic device by a patient.

23. acquiring patient objective sleep recording data automatically using one or more environmental sensors of said consumer electronic device; displaying the patient objective sleep recording data on the display; 2. The method of claim 1, comprising:

24. transmitting the therapy data from the consumer electronic device to a remote server; displaying the treatment data on a display coupled to the remote server; 2. The method of claim 1, comprising:

25. a therapeutic device implantable within the patient; a consumer electrical device operable by the patient; the consumer electrical device is configured to control a predefined set of therapeutic device functions in response to patient input to the consumer electrical device; The consumer electrical device further comprises: receiving treatment data transmitted from the treatment device; A system configured to display the treatment data on a display of the consumer electrical device.

26. 26. The system of claim 25, wherein the predefined set of therapy device functions comprises turning on the therapy device, turning off the therapy device, and discontinuing therapy delivery by the therapy device.

27. 26. The system of claim 25, wherein the predefined set of therapeutic device functions comprises adjusting a magnitude of therapy provided by the therapeutic device.

28. 26. The system of claim 25, wherein the therapy data comprises therapy utilization data.

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