Implantable medical device system configured for urinary tract infection determination

Abstract

An example system includes an implantable medical device (IMD) includes a temperature sensor configured to sense body temperature of a patient, and an accelerometer configured to sense activity of the patient; and processing circuitry configured to: generate an initial determination, based at least in part on one or more of the sensed activity of the patient and the sensed body temperature, the patient has a urinary tract infection (UTI), in response to the initial determination that the patient has the UTI, cause a computing device to generate an output requesting the patient provide one or more patient inputs to respective questions regarding patient symptoms, receive the one or more patient inputs, and determine the patient has the UTI based, at least in part, on the received patient inputs.

Description

IMPLANTABLE MEDICAL DEVICE SYSTEM CONFIGURED FOR URINARY TRACT INFECTION DETERMINATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 619,534, filed January 10, 2024, the entire content of which is incorporated herein by reference.TECHNICAL FIELD

[0002] The invention relates to medical device systems and, more particularly, medical device systems for determining a condition of a patient.BACKGROUND

[0003] Many people suffer from urinary tract infections (UTIs). Over 10% of women older than 65 years of age reported having a UTI within the past 12 months. This number increases to almost 30% in women over the age of 85 years. When treated promptly and properly, lower UTIs rarely lead to complications. Left untreated, however, a UTI can have serious consequences. Complications of a UTI may include recurrent infections, especially in women who experience two or more UTIs in a six-month period or four or more UTIs within a year; permanent kidney damage from an acute or chronic kidney infection (pyelonephritis) due to an untreated UTI; increased risk in pregnant women of delivering low birth weight or premature infants; urethral narrowing (stricture) in men from recurrent urethritis, previously seen with gonococcal urethritis; and / or sepsis, a potentially life-threatening complication of an infection, especially if the infection works its way up the urinary tract to the kidneys. One example symptom of a UTI is nocturia, which is characterized by the need to urinate while a patient is sleeping, thereby possibly interrupting a sleep state of the patient.SUMMARY

[0004] In general, the disclosure is directed toward techniques for determining the onset or presence of a UTI in a patient based at least in part on data collected by an accelerometer and a temperature sensor of an implantable medical device system, and responsively prompting the patient with questions regarding patient symptoms todetermine / confirm the presence of the UTI in the patient based at least in part on patient inputs received in response to the respective questions. More specifically, a medical device system may include an implantable medical device comprising a temperature sensor to sense body temperature of the patient and an accelerometer configured to sense activity of the patient. The medical device system further includes processing circuitry configured to generate an initial determination that the patient has a UTI based on one or more of the sensed activity of the patient or the sensed body temperature of the patient. In response to the initial determination that the patient has a UTI, processing circuitry causes a computing device to generate an output requesting the patient provide one or more patient inputs to respective questions regarding patient symptoms. For example, processing circuitry may automatically cause a computing device to generate an output requesting the patient provide one or more patient inputs to respective questions regarding patient symptoms. Processing circuitry is configured to receive the one or more patient inputs and determine / confirm the patient has the UTI based, at least in part, on the received patient inputs.

[0005] The techniques described herein may provide one or more advantages. For example, use of an implantable medical device comprising a temperature sensor and accelerometer for initial identification of possible UTI may enable continuous (e.g., periodically or on a triggered basis without requiring user intervention) surveillance of the patient for UTIs over a period months or years while the patient is outside of a clinic setting and without requiring significant patient compliance burden. Moreover, the techniques of causing a computing device to generate an output requesting the patient provide one or more patient inputs to respective questions regarding patient symptoms in response to the initial determination that the patient has a UTI and using the patient inputs to determine / confirm the patient has the UTI, may provide improved accuracy of determining UTI. The system including an implantable medical device and techniques described herein may advantageously improve the speed of determining a UTI in a patient that may help enable treatment to be provided quicker to the patient, which improves patient health, reduces chances of serious illness caused by the UTI, which reduces hospitalizations and reduces healthcare costs. Further, such embodiments may enable monitoring and performance of novel computations in a continuous manner; thiscontinuous operation can overcome limitations of a physician’s capability, for whom such continuous attention, monitoring, and computation would be infeasible.

[0006] In one example, this disclosure describes a system comprising: an implantable medical device (IMD) comprising: a temperature sensor configured to sense body temperature of a patient, and an accelerometer configured to sense activity of the patient; and processing circuitry configured to: generate an initial determination, based at least in part on one or more of the sensed activity of the patient and the sensed body temperature, the patient has a urinary tract infection (UTI), in response to the initial determination that the patient has the UTI, cause a computing device to generate an output requesting the patient provide one or more patient inputs to respective questions regarding patient symptoms, receive the one or more patient inputs, and determine the patient has the UTI based, at least in part, on the received patient inputs.

[0007] In another example, this disclosure describes a method for determining a patient has a urinary tract infection (UTI) comprising: sensing, by an implantable medical device (IMD), one or more of activity of the patient or body temperature of the patient; generating, by processing circuitry, an initial determination the patient has the UTI based at least in part on one or more of the sensed activity of the patient and the sensed body temperature; in response to the initial determination that the patient has the UTI, causing, by the processing circuitry, a computing device to generate an output requesting the patient provide one or more patient inputs to respective questions regarding patient symptoms; receiving, by the processing circuitry, the one or more patient inputs; and determining, by the processing circuitry, the patient has the UTI based, at least in part, on the received patient inputs.

[0008] In another example, this disclosure describes non-transitory computer-readable storage medium storing instructions, which when executed, cause processing circuitry to: sense, by an implantable medical device (IMD), one or more of activity of the patient or body temperature of the patient; generate, by processing circuitry, an initial determination the patient has the UTI based at least in part on one or more of the sensed activity of the patient and the sensed body temperature; in response to the initial determination that the patient has the UTI, cause, by the processing circuitry, a computing device to generate an output requesting the patient provide one or more patient inputs to respective questions regarding patient symptoms; receive, by the processing circuitry, the one or more patientinputs; and determine, by the processing circuitry, the patient has the UTI based, at least in part, on the received patient inputs.

[0009] The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0010] FIG. 1 is a schematic diagram illustrating a system configured to monitor for the presence of a UTI in a patient, in accordance with some techniques of this disclosure.

[0011] FIG. 2 is a block diagram illustrating an example implantable medical device configured to monitor for the presence of a UTI in a patient, in accordance with some techniques of this disclosure.

[0012] FIG. 3 is a block diagram illustrating an example computing device configured to monitor for the presence of a UTI in a patient, in accordance with some techniques of this disclosure.

[0013] FIG. 4A is a conceptual side-view diagram illustrating an example configuration of the IMD of FIGS. 1-2, in accordance with some techniques of this disclosure.

[0014] FIG. 4B is a conceptual side-view diagram illustrating an example configuration of the IMD of FIGS. 1-2, in accordance with some techniques of this disclosure.

[0015] FIG. 5 is a block diagram illustrating an example system that includes an access point, a network, external computing devices, such as a server, and one or more other computing devices, which may be coupled to the IMD and computing device of FIGS. 1- 4, in accordance with some techniques of this disclosure.

[0016] FIG. 6 is a flow diagram illustrating an example method of determining / confirming an initial determination that the patient has a UTI, according to techniques of this disclosure.DETAIEED DESCRIPTION

[0017] UTIs are a condition that affects the quality of life and health of many people. UTI can be an underdiagnosed cause of a large number of hospitalizations and severe health declines, especially in elderly women. Many of these hospitalizations could beprevented with simple antibiotics if the UTI is caught earlier. An elderly woman has a similar chance of hospitalization for UTI as for myocardial infarct (MI) or Stroke.

[0018] Techniques described herein may include initially determining a UTI based on changes in body temperature, such as a fever, and / or changes (e.g., increases) in nighttime trips to the bathroom to urinate over a short period of time, such as within 3 days. The techniques described herein cause, in response to the initial determination of a UTI, a notification to be sent to a computing device, such as a patient smart phone, smart watch, or tablet, to cause the computing device to generate an output requesting patient input(s) to respective questions regarding patient symptoms. The techniques described herein determine / confirm that the patient has the UTI based, at least in part, on the received patient inputs. As described in further detail below, these techniques of causing a computing device to generate and output requesting the patient provide inputs and determining / confirming the UTI based on the patient inputs improves the accuracy and speed of the UTI determinations, which helps catch UTIs earlier so patient may receive treatments, such as antibiotics, sooner to reduce potential hospitalizations caused by a UTI.

[0019] FIG. 1 is a schematic diagram illustrating an example UTI detection system 2, including a computing device 12 configured to determine whether a patient 4 likely has a UTI, based on data sensed by one or more implantable medical devices (IMDs), such as IMD 10 withing the body of patient 4, as well as data collected by computing device 12. One or more IMDs may include a wide variety of different types of sensors, configured to collect various data indicative of one or more physical parameters or behaviors of patient 4.

[0020] IMD 10 may take the form of an insertable cardiac monitor (ICM) having electrodes configured to collect data, such as a subcutaneous electrocardiogram (ECG) signal and / or an intracardiac electrogram (EGM) signal indicative of electrical activity of a heart of patient 4. IMD 10 may also be configured with one or more sensors to collect other physiological data, such as one or more accelerometers configured to detect movement, steps, and posture / orientation, one or more temperature sensors, electrodes to sense respiration or perfusion, which may be the same or different than the ECG / EGM electrodes, and / or one or more optical sensors (photoplethysmography (PPG) sensors) to sense oxygen saturation or mechanical activity of the heart.

[0021] Some examples of an ICM are the Reveal LINQOZ) and LINQ II® insertable cardiac monitors, available from Medtronic PLC. Other examples of IMD 10 include devices configured as pacemakers, cardioverters, and / or defibrillators, which may include one or more electrodes positioned on, within, or near the heart, e.g., via one or more leads, to sense a cardiac EGM. Other examples of IMD 10 include a leadless intracardiac pacemaker, such as a Micra® Transcatheter Pacing System from Medtronic, PLC. Such devices may include additional sensors as described herein.

[0022] UTI detection system 2 may include computing device 12. Computing device 12 may be a computing device with a display viewable by the user and an interface for providing input to computing device 12 (e.g., a user input mechanism). In some examples, computing device 12 may be a notebook computer, tablet computer, workstation, one or more servers, cellular phone, personal digital assistant, or another computing device that may run an application that enables the computing device to interact with IMD 10. Computing device 12 is configured to communicate with IMD 10 and, optionally, another computing device (not illustrated in FIG. 1), via wireless communication. Computing device 12, for example, may communicate via near-field communication technologies (e.g., inductive coupling, NFC or other communication technologies operable at ranges less than 10-20 cm) and far-field communication technologies (e.g., RF telemetry according to the 802.11 or Bluetooth® specification sets, or other communication technologies operable at ranges greater than near-field communication technologies).

[0023] Computing device 12 may be used to configure operational parameters for IMD 10. Computing device 12 may be used to retrieve data from IMD 10. The retrieved data may include values of physiological parameters measured by IMD 10, such as body temperature sensed by IMD and metrics of out of bed and / or urination by patient 4, or other metrics of activity of patient 4 sensed by IMD 10. In some examples, physiological parameters measured by IMD 10 may additionally or alternatively include heart rate (HR), heart-rate variability (HRV), such as a decreased HRV over a period of time, which may help indicate a presence of a UTI. The retrieved data may include physiological signals recorded by IMD 10. In examples in which IMD 10 confirms / determines UTI, computing device 12 may be used to send patient input data to IMD 10, such as patient inputs to respective questions regarding patient symptoms. In some examples computing device 12 confirms / determines UTI based on patient responses to questions posed by computingdevice 12 and, in some examples, the data retrieved from IMD 10, e.g., temperature and activity data.

[0024] In some examples in accordance with this disclosure, IMD 10 is configured to determine whether patient 4 satisfies a UTI threshold based on one or more of sensed patient activity or sensed body temperature. In some examples, IMD 10 may determine a UTI threshold is satisfied based on determining one or more of sensed patient activity satisfying a UTI increased bathroom trip threshold and / or sensed body temperature satisfying a UTI fever threshold. In some examples, IMD 10 may determine a UTI threshold is satisfied based on determining one or more of a degree that sensed patient activity satisfies a UTI increased bathroom trip threshold and / or a degree that a sensed body temperature satisfies a UTI fever threshold. In some examples, in addition to sensed patient activity satisfying a UTI increased bathroom trip threshold and / or sensed body temperature satisfying a UTI fever threshold, IMD 10 may further determine a UTI threshold is satisfied based on one or more other metrics, such as HR or HRV, measured by IMD 10 satisfying a corresponding other metrics UTI threshold. In response to a determination that the patient satisfied the UTI threshold, processing circuitry of IMD 10 is configured to cause computing device 12 to generate an output requesting patient provide or more patient inputs to respective questions regarding patient symptoms. For example, IMD 10 may be configured to send a notification or other message to computing device 12 in response to satisfaction of the UTI threshold to cause computing device 12 to generate an output requesting patient provide or more patient inputs to respective questions regarding patient symptoms. In some examples, the respective questions may correspond to values of sensed body temperature and / or the sensed patient activity. For example, patient questions may include follow-up questions regarding increased levels of patient activity potentially associated with getting out of bed and / or urinating and / or body temperature levels that indicate a fever. In some examples, the follow-up questions may correspond to other UTI symptoms, such as: fatigue and / or tremors; agitation and / or restlessness; lower back pain; painful urination (e.g., a “burning” sensation); and / or presyncope and / or syncope (e.g., sudden loss of consciousness and / or falls).

[0025] In some examples, IMD 10 may determine a UTI threshold is satisfied (e.g., patient has a UTI) based on applying one or more of sensed activity of the patient and sensed body temperature to a machine learning model and the machine learning modeldetermining the one or more of sensed activity of the patient and sensed body temperature indicates patient 4 has a UTI. In some examples, IMD 10 may determine patient 4 has a UTI based on applying one or more of sensed activity of the patient, sensed body temperature, and one or more other metrics measured by IMD 10 to a machine learning model and the machine learning model determining the one or more of sensed activity of the patient, sensed body temperature, and one or more other metrics measured by IMD 10 indicates patient 4 has a UTI.

[0026] IMD 10 and / or computing device 12 may receive the one or more patient inputs to the respective questions regarding patient symptoms and determine / confirm that the patient is likely suffering a UTI based, at least in part, on the received patient inputs to the respective questions regarding patient symptoms in response to the initial determination of a UTI.

[0027] FIG. 2 is a functional block diagram illustrating an example configuration of IMD 10. the illustrated example, IMD 10 includes electrodes 16A and 16B (collectively “electrodes 16”), antenna 46, processing circuitry 50, sensing circuitry 52, communication circuitry 54, storage device 56, and sensors 62. IMD 10 may also include a power source.

[0028] Processing circuitry 50 may include fixed function circuitry and / or programmable processing circuitry. Processing circuitry 50 may include any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or equivalent discrete or analog logic circuitry. In some examples, processing circuitry 50 may include multiple components, such as any combination of one or more microprocessors, one or more controllers, one or more DSPs, one or more ASICs, or one or more FPGAs, as well as other discrete or integrated logic circuitry. The functions attributed to processing circuitry 50 herein may be embodied as software, firmware, hardware or any combination thereof.

[0029] Sensing circuitry 52 may monitor signals from sensors 62, which may include one or more accelerometers 62A, temperature sensors 62B, pressure sensors, and / or optical sensors, as examples. In some examples, sensing circuitry 52 may include one or more filters and amplifiers for filtering and amplifying signals received from sensors 62. In some examples, the one or more accelerometers 62 A may be configured to generate signals that indicate motion of patient 4, e.g., that indicate activity level of the patient. Insome examples, processing circuitry 50 processes such signals to determine values of one or more physiological parameters that can be used to determine probability of a health event. For example, processing circuitry 50 may quantify duration, frequency, and / or intensity of activity changes, e.g., daily or during some other period. In some examples, processing circuitry 50 may determine an amount of time patient 4 spends inactive, e.g., sleeping. In some examples, the one or more temperature sensors 62B may be configured to generate signals that indicate body temperature of patient 4. In some examples, processing circuitry 50 may quantify an amount of change in HRV over a period of time, such as a decrease in HRV over a period of time.

[0030] In some examples, processing circuitry 50 may be configured to analyze the accelerometer data in order to identify activity patterns likely due to a bladder-voiding event, e.g., rather than a different nighttime activity. In some examples, processing circuitry 50 may use accelerometer data to determine a posture of patient 4, with certain upright postures, or transitions to and from upright postures, indicating that the patient has awoken and returned to sleep. In some examples, processing circuitry 50 may identify a number of steps during the first or second increased activity level, and determine whether the number of steps is indicative of (e.g., falls within a threshold window of) the patient walking between the bedroom and the bathroom. In another example, processing circuitry 50 may be configured to receive time duration data, e.g., from a clock or timer included as part of processing circuitry 50, collected during one or more of the detected activity levels, and determine whether the time duration is indicative of, e.g., falls within a threshold window of, the patient walking to the bathroom, voiding a bladder, or returning to the bedroom, respectively. In another example, processing circuitry 50 may be configured to determine, based on the received activity-level data, whether a cumulative activity level amount (e.g., the detected activity level integrated over the time during which the level is detected) is indicative of the patient walking to and / or from the bathroom. In some examples, processing circuitry 50 may identify an out of bed (OOB) event based on the activity data, e.g., level, steps, or duration, falling within threshold window that is determined statistically based on previous OOB events of the patient or of a population of patients. In some examples, processing circuitry 50 may identify an OOB event based on the activity data and HR data, such as HR data showing an increased HR over a period of time that may indicate patient transitioned from a sleeping state to an awake state. In someexamples, processing circuitry 50 may begin monitoring activity data in response to determining patient transitioned from a sleeping state to an awake state.

[0031] In some examples, processing circuitry 50 may be configured to identify a level (e.g., a frequency such as an increased frequency) of nighttime urination events (e.g., nocturia) by monitoring the patient’s sensed activity level. In some examples, processing circuitry 50 may be configured to determine a baseline amount of nighttime bathroom trips for the patient 4 based on at least in part on the sensed activity during a baseline period of time. Processing circuitry 50 may be configured to determine an amount of nighttime bathroom trips for the patient for a particular period of time based at least in part on the sensed activity during the particular period of time. For example, the particular period of time may be one night. In some examples, the particular period of time may up to 3 nights. In some examples, the particular period of time may up to 5 nights. In some examples, processing circuitry 50 may compare the amount of nighttime bathroom trips for the particular period of time to the baseline amount of nighttime bathroom trips to determine a difference between the amount of nighttime bathroom trips for the particular period of time to the baseline amount of nighttime bathroom trips. In some examples, processing circuitry 50 may determine whether the difference between the amount of nighttime bathroom trips for the particular period of time to the baseline amount of nighttime bathroom trips satisfies a UTI increased bathroom trip threshold for the particular period of time. In some examples, a UTI increased bathroom trip threshold may be one or more increased trips to the bathroom per night. In some examples, a UTI increased bathroom trip threshold may be two or more trips to the bathroom per night. For example, if processing circuitry 50 determines the baseline amount of nighttime bathroom trips is two and processing circuitry 50 determines the patient 4 has four bathroom trips per night during the particular period of time, such as one night, two nights, or three nights, processing circuitry 50 may determine that the determined difference between the amount of nighttime bathroom trips for the particular period of time to the baseline amount of nighttime bathroom trips satisfies the UTI increased bathroom trip threshold. In some examples, IMD 10 may determine a difference between the amount of nighttime bathroom trips for the particular period of time to the baseline amount of nighttime bathroom trips satisfies a UTI increased bathroom trip threshold based on applying the difference to amachine learning model and the machine learning model determining the difference satisfies the UTI increased bathroom trip threshold.

[0032] Some examples for determining an increased frequency of nighttime urination events (e.g., nocturia) are described in commonly-assigned U.S. Patent Application No. 16 / 720,487, entitled, “URINARY TRACT INFECTION DETERMINATION” to Bruce D. Gunderson et al, incorporated herein by reference in its entirety.

[0033] In some examples, processing circuitry 50 may determine whether patient 4 has a fever for the particular period of time based on the sensed body temperature sensed by the temperature sensor 62B. In some examples, processing circuitry 50 may determine whether the sensed body temperature during the particular period of time satisfies a UTI fever threshold and may determine patient 4 has a fever for the particular period of time based on the sensed body temperature during the particular period of time satisfying a UTI fever threshold. In some examples, the particular period of time may correspond to the particular period of time processing circuitry 50 determines that the determined difference between the amount of nighttime bathroom trips for the particular period of time to the baseline amount of nighttime bathroom trips satisfies the UTI increased bathroom trip threshold.

[0034] In some examples, in response to a determination that the comparison of the amount of bathroom trips for the particular period of time to the baseline average amount of nighttime bathroom trips for the patient satisfies the UTI increased bathroom trip threshold for the particular period of time and the patient has a fever for the particular period of time, processing circuitry 50 may initially determine patient 4 has a UTI.

[0035] In response to the initial determination that the patient has the UTI, processing circuitry 50 may cause computing device 12 to generate an output requesting patient 4 provide one or more patient inputs to respective questions regarding patient symptoms, such as by sending a notification to computing device 12 to generate an output requesting patient provide one or more patient inputs to respective questions regarding patient symptoms. In some examples, the output requesting patient provide one or more patient inputs may be a push notification. In some examples, the respective questions may correspond to values of sensed body temperature and / or the sensed patient activity. For example, patient questions may include follow-up questions regarding increased levels of patient activity and / or body temperature levels that indicate a fever. In some examples, thefollow-up questions may correspond to other UTI symptoms, such as fatigue and / or tremors; agitation and / or restlessness; lower back pain; painful urination (e.g., a “burning” sensation); and / or presyncope and / or syncope (e.g., sudden loss of consciousness and / or falls).

[0036] In some examples, in response to the initial determination that the patient has the UTI, processing circuitry 50 may automatically cause a notification to computing device 12 to generate an output requesting patient 4 provide one or more patient inputs to respective questions regarding patient symptoms, such as by sending a notification to computing device 12 to generate an output requesting patient 4 provide one or more patient inputs to respective questions regarding patient symptoms. In some examples, processing circuitry 50 initially determining that the patient has the UTI based on body temperature and patient activity and automatically causing computing device 12 to generate an output requesting patient 4 provide one or more patient inputs to respective questions regarding patient symptoms to determine whether to determine / confirm the patient 4 has the UTI, provides improved determinations of a UTI while also making the determinations more efficient and faster than a patient 4 waiting to interact with a care provider. This improvement in accuracy and time to determine patient 4 has a UTI enables treatment to be provided sooner to the patient, which improves patient 4 health while reducing chances of hospitalizations, which reduces healthcare costs.

[0037] In some examples, processing circuitry 50 may receive the one or more patient 4 inputs and determine whether to determine / confirm the patient has the UTI based, at least in part, on the received patient inputs. For example, processing circuitry 50 may receive user inputs that indicate the patient 4 has painful urination and was having to use the bathroom at a much higher rate than normal and determine / confirm patient symptoms indicate a UTI. In some examples, in response to a determination that the patient has the UTI, processing circuitry 50 may send one or more of an indication to see a care provider, an indication to go to an emergency room, and / or an indication to proceed with a treatment, such as taking a particular medication. In some examples, processing circuitry 50 may additionally or alternatively send a confirmation request to patient 4 to confirm, such as by patient input, that the patient computing device received an indication such as an indication that the patient has a UTI, to see a care provider, an indication to go to anemergency room, and / or an indication to proceed with a treatment, such as taking a particular medication.

[0038] FIG. 3 is a block diagram illustrating an example computing device 12 in accordance with techniques of this disclosure. In some examples, computing device 12 may be a patient computing device, such as a patient smart phone, tablet, or personal computer. Computing device 12 includes a communication element 230, memory 240, processing circuitry 260, power source 280, communication circuitry 300, a user interface 310, and in some examples, one or more integrated sensor(s) 320. Although communication element 230 is depicted in FIG. 3 as an antenna, communication element 230 may include any physical component configured to facilitate communication with, e.g., to receive sensor data from IMD 10 (FIG. 1).

[0039] Memory 240 of computing device 12 may include any volatile or non-volatile media, such as any one or more of a random access memory (RAM), read-only memory (ROM), nonvolatile RAM (NVRAM), electronically-erasable programmable ROM (EEPROM), flash memory, and the like, all of which may constitute “non-transitory storage media.” Memory 240 is configured to store sensor data as well as instructions that, when executed by processing circuitry 260, cause processing circuitry 260 to process the stored sensor data to identify sensor data indicative of one or more symptoms of a UTI, and based on the analysis of the sensor data, determine whether a UTI is likely present in a patient, e.g., determine a probability that a patient has a UTI. Memory 240 may also store data generated by IMD 10 (FIG. 1) and / or processing circuitry 260.

[0040] Processing circuitry 260 may include any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), discrete logic circuitry, or the like. Processing circuitry 260 is configured to execute one or more sets of instructions according to the techniques of this disclosure. For example, processing circuitry 260 may be configured to receive, via communication element 230 and communication circuitry 300 from IMD 10 (FIG. 1), sensor data indicative of activity of the patient and body temperature of the patient.

[0041] Processing circuitry 260 may be coupled to power source 280. Power source 260 may include a battery and / or wired power connection. In examples in which computing device is integrated within a sensor device, such as implantable sensor device10, power source 280 may take the form of a small, rechargeable or non-rechargeable battery, or an inductive power interface that transcutaneously receives inductively coupled energy. In the case of a rechargeable battery, power source 280 similarly may include an inductive power interface for transcutaneous transfer of recharge power.

[0042] User interface 310 of computing device 12 may include one or more user input devices and one or more user output devices, e.g., a touch screen display or other display, a pointing device, a keyboard, or the like. In response to an initial determination by processing circuitry 50 that the patient has a UTI and processing circuitry sending a notification to generate an output requesting patient 4 provide one or more patient inputs to respective questions regarding patient symptoms, processing circuitry 260 may present a variety of information to a user, including respective questions regarding patient symptoms, via user interface 310.

[0043] Communication circuitry 300 supports wireless communication with IMD 10 that generates signals indicative of physiological parameters patient 4 and transmits the signals and / or physiological parameters determined based on the signals to computing device 12. Communication circuitry 300 is configured to support wireless communication for computing device 12 to receive a notification from the IMD 10 to generate an output requesting patient 4 to provide one or more patient inputs to respective questions regarding patient symptoms. In some examples, computing device 12 may output the respective questions via user interface 310 and / or a speaker. In some examples, computing device 12 may receive user inputs to the respective questions via user interface 310 and / or a microphone. Computing device 12 may transmit the one or more patient 4 inputs in response to the respective questions to IMD 10 using communication circuitry 300. Such communication may be via any wireless communication protocol, such as known medical device telemetry protocols, or the Bluetooth™ protocol.

[0044] In some examples, computing device 12 includes one or more sensor(s) 320. Sensor(s) 320 may include any one or more of the example sensors discussed herein with respect to sensors 62 of IMD 10 (FIGS. 1-2). In some examples, sensor(s) 320 may one or more of a microphone or a camera to capture audio and / or image data of patient 14.

[0045] FIG. 4A is a conceptual drawing illustrating an IMD 10A, which may be an example configuration of IMD 10 of FIGS. 1-2 as an ICM. In the example shown in FIG. 4A, IMD 10A may be embodied as a monitoring device having housing 15, proximalelectrode 16A and distal electrode 16B, and sensor(s) 62. The sensor(s) 62 may be positioned at various locations on IMD 10A. Sensor(s) 62 may include one or more accelerometers 62A and one or more temperature sensors 62B. Housing 15 may further comprise first major surface 14, second major surface 18, proximal end 20, and distal end 22. Housing 15 encloses electronic circuitry located inside the IMD 10A and protects the circuitry contained therein from body fluids. Electrical feedthroughs provide electrical connection of electrodes 16A and 16B.

[0046] In the example shown in FIG. 4A, IMD 10A is defined by a length L, a width W and thickness or depth D and is in the form of an elongated rectangular prism wherein the length L is much larger than the width W, which in turn is larger than the depth D. In one example, the geometry of the IMD 10A - in particular a width W greater than the depth D - is selected to allow IMD 10A to be inserted under the skin of the patient using a minimally invasive procedure and to remain in the desired orientation during and after insertion. For example, the device shown in FIG. 4A includes radial asymmetries (notably, the rectangular shape) along the longitudinal axis that maintains the device in the proper orientation following insertion. For example, the spacing between proximal electrode 64 and distal electrode 66 may range from 30 millimeters (mm) to 55mm, 35mm to 55mm, and from 40mm to 55mm and may be any range or individual spacing from 25mm to 60mm. In addition, IMD 10A may have a length E that ranges from 30mm to about 70mm. In other examples, the length L may range from 5mm to 60mm, 15mm to 50mm, 40mm to 60mm, 45mm to 60mm and may be any length or range of lengths between about 5mm and about 80mm. In addition, the width W of major surface 14 may range from 5mm to 15mm, 3mm to 10mm, and may be any single or range of widths between 3mm and 15mm. The thickness of depth D of IMD 10A may range from 2mm to 9mm. In other examples, the depth D of IMD 10A may range from 2mm to 5mm, may range from 5mm to 15mm, and may be any single or range of depths from 2mm to 15mm. In addition, IMD 10A according to an example of the present disclosure has a geometry and size designed for ease of implant and patient comfort. Examples of IMD 10A described in this disclosure may have a volume of three cubic centimeters (cm) or less, 1.5 cubic cm or less or any volume between three and 1.5 cubic cm.

[0047] In the example shown in FIG. 4A, once inserted within the patient, the first major surface 14 faces outward, toward the skin of the patient while the second majorsurface 18 is located opposite the first major surface 14. In addition, in the example shown in FIG. 4A, proximal end 20 and distal end 22 are rounded to reduce discomfort and irritation to surrounding tissue once inserted under the skin of the patient. IMD 10A, including instrument and method for inserting IMD 10 is described, for example, in U.S. Patent Publication No. 2014 / 0276928, incorporated herein by reference in its entirety.

[0048] Proximal electrode 16A and distal electrode 16B are used to sense cardiac signals, e.g. EGM signals, intra-thoracically or extra-thoracically, which may be sub- muscularly or subcutaneously. EGM signals may be stored in a memory of IMD 10A, and data may be transmitted via integrated antenna 30A to another medical device, which may be another implantable device or an external device, such as external device 12. In some example, electrodes 16A and 16B may additionally or alternatively be used for sensing any bio-potential signal of interest, which may be, for example, an ECG, EGM, EEG, EMG, or a nerve signal, from any implanted location.

[0049] In the example shown in FIG. 4A, proximal electrode 16A is in close proximity to the proximal end 20 and distal electrode 16B is in close proximity to distal end 22. In this example, distal electrode 16B is not limited to a flattened, outward facing surface, but may extend from first major surface 14 around rounded edges 24 and / or end surface 25 and onto the second major surface 18 so that the electrode 16B has a three-dimensional curved configuration. In some examples, electrode 16B is an uninsulated portion of a metallic, e.g., titanium, part of housing 15.

[0050] In the example shown in FIG. 4A, proximal electrode 16A is located on first major surface 14 and is substantially flat, and outward facing. However, in other examples proximal electrode 16A may utilize the three dimensional curved configuration of distal electrode 16B, providing a three dimensional proximal electrode (not shown in this example). Similarly, in other examples distal electrode 16B may utilize a substantially flat, outward facing electrode located on first major surface 14 similar to that shown with respect to proximal electrode 16A.

[0051] The various electrode configurations allow for configurations in which proximal electrode 16A and distal electrode 16B are located on both first major surface 14 and second major surface 18. In other configurations, such as that shown in FIG. 4A, only one of proximal electrode 16A and distal electrode 16B is located on both major surfaces 14 and 18, and in still other configurations both proximal electrode 16A and distal electrode16B are located on one of the first major surface 14 or the second major surface 18 (e.g., proximal electrode 16A located on first major surface 14 while distal electrode 16B is located on second major surface 18). In another example, IMD 10A may include electrodes on both major surface 14 and 18 at or near the proximal and distal ends of the device, such that a total of four electrodes are included on IMD 10A. Electrodes 16A and 16B may be formed of a plurality of different types of biocompatible conductive material, e.g., stainless steel, titanium, platinum, iridium, or alloys thereof, and may utilize one or more coatings such as titanium nitride or fractal titanium nitride.

[0052] In the example shown in FIG. 4A, proximal end 20 includes a header assembly 28 that includes one or more of proximal electrode 16A, integrated antenna 30A, antimigration projections 32, and / or suture hole 34. Integrated antenna 30A is located on the same major surface (i.e., first major surface 14) as proximal electrode 16A and is also included as part of header assembly 28. Integrated antenna 30A allows IMD 10A to transmit and / or receive data. In other examples, integrated antenna 30A may be formed on the opposite major surface as proximal electrode 16A, or may be incorporated within the housing 15 of IMD 10A. In the example shown in FIG. 4A, anti-migration projections 32 are located adjacent to integrated antenna 30A and protrude away from first major surface 14 to prevent longitudinal movement of the device. In the example shown in FIG. 4A, anti-migration projections 32 include a plurality (e.g., nine) small bumps or protrusions extending away from first major surface 14. As discussed above, in other examples anti-migration projections 32 may be located on the opposite major surface as proximal electrode 16A and / or integrated antenna 30A. In addition, in the example shown in FIG. 4A, header assembly 28 includes suture hole 34, which provides another means of securing IMD 10A to the patient to prevent movement following insertion. In the example shown, suture hole 34 is located adjacent to proximal electrode 16A. In one example, header assembly 28 is a molded header assembly made from a polymeric or plastic material, which may be integrated or separable from the main portion of IMD 10A.

[0053] FIG. 4B is a perspective drawing illustrating another IMD 10B, which may be another example configuration of IMD 10 from FIGS. 1-2. IMD 10B of FIG. 4B may be configured substantially similarly to IMD lOA of FIG. 4A, with differences between them discussed herein.

[0054] IMD 10B may include a leadless, subcutaneously-implantable monitoring device, e.g. an ICM. IMD 10B includes housing having a base 40 and an insulative cover 42. IMD 10B includes sensor(s) 62 that may be positioned at various locations on IMD 10B. Sensor(s) 62 may include one or more accelerometers 62A and one or more temperature sensors 62B. Proximal electrode 16C and distal electrode 16D may be formed or placed on an outer surface of cover 42. Various circuitries and components of IMD 10B, e.g., described below with respect to FIG. 3, may be formed or placed on an inner surface of cover 42, or within base 40. In some examples, a battery or other power source of IMD 10B may be included within base 40. In the illustrated example, antenna 30B is formed or placed on the outer surface of cover 42, but may be formed or placed on the inner surface in some examples. In some examples, insulative cover 42 may be positioned over an open base 40 such that base 40 and cover 42 enclose the circuitries and other components and protect them from fluids such as body fluids.

[0055] Circuitries and components may be formed on the inner side of insulative cover 42, such as by using flip-chip technology. Insulative cover 42 may be flipped onto a base 40. When flipped and placed onto base 40, the components of IMD 10B formed on the inner side of insulative cover 42 may be positioned in a gap 44 defined by base 40. Electrodes 16C and 16D and antenna 30B may be electrically connected to circuitry formed on the inner side of insulative cover 42 through one or more vias (not shown) formed through insulative cover 42. Insulative cover 42 may be formed of sapphire (i.e., corundum), glass, parylene, and / or any other suitable insulating material. Base 40 may be formed from titanium or any other suitable material (e.g., a biocompatible material). Electrodes 16C and 16D may be formed from any of stainless steel, titanium, platinum, iridium, or alloys thereof. In addition, electrodes 16C and 16D may be coated with a material such as titanium nitride or fractal titanium nitride, although other suitable materials and coatings for such electrodes may be used.

[0056] In the example shown in FIG. 4B, the housing of IMD 10B defines a length L, a width W and thickness or depth D and is in the form of an elongated rectangular prism wherein the length L is much larger than the width W, which in turn is larger than the depth D, similar to IMD 10A of FIG. 4B. For example, the spacing between proximal electrode 64 and distal electrode 66 may range from 30mm to 50mm, from 35mm to 45mm, or be approximately 40mm. In addition, IMD 10B may have a length L that rangesfrom 30mm to about 70mm. In other examples, the length L may range from 5mm to 60mm, 40mm to 60mm, 45mm to 55mm, or be approximately 45mm. In addition, the width W may range from 3mm to 15mm, such as approximately 8mm. The thickness of depth D of IMD 10B may range from 2mm to 15mm, from 3 to 5mm, or be approximately 4mm. IMD 10B may have a volume of three cubic centimeters (cm) or less, or 1.5 cubic cm or less, such as approximately 1.4 cubic cm.

[0057] In the example shown in FIG. 4B, once inserted subcutaneously within the patient, outer surface of cover 42 faces outward, toward the skin of the patient. In addition, as shown in FIG. 4B, proximal end 46 and distal end 48 are rounded to reduce discomfort and irritation to surrounding tissue once inserted.

[0058] FIG. 5 is a block diagram illustrating an example system that includes an access point 90, a network 92, external computing devices, such as a server 94, and one or more computing devices 100A-100N (collectively, “computing devices 100”), which may be coupled to IMD 10 and external device 12 via network 92, in accordance with one or more techniques described herein. The external device 12 in FIG. 5 corresponds to the computing device 12 ins FIGS. 1 and 3. In this example, IMD 10 may use communication circuitry 54 to communicate with external device 12 via a first wireless connection, and to communicate with an access point 90 via a second wireless connection. In the example of FIG. 6, access point 90, external device 12, server 94, and computing devices 100 are interconnected and may communicate with each other through network 92.

[0059] Access point 90 may include a device that connects to network 92 via any of a variety of connections, such as telephone dial-up, digital subscriber line (DSL), or cable modem connections. In other examples, access point 90 may be coupled to network 92 through different forms of connections, including wired or wireless connections. In some examples, access point 90 may be a user device, such as a tablet or smartphone, that may be co-located with the patient. IMD 10 may be configured to transmit data, such as temperature data, accelerometer signals, indications of whether the patient has an initial determination of having a UTI, signals to cause a computing device to generate an output requesting the patient provide one or more patient inputs to respective questions regarding patient symptoms, indications of whether the patient is determined to have the UTI, and / or indications of treatment instructions to access point 90. Access point 90 may then communicate the retrieved data to server 94 via network 92.

[0060] In some cases, server 94 may be configured to provide a secure storage site for data that has been collected from IMD 10 and / or external device 12. In some cases, server 94 may assemble data in web pages or other documents for viewing by trained professionals, such as clinicians, via computing devices 100. One or more aspects of the illustrated system of FIG. 5 may be implemented with general network technology and functionality, which may be similar to that provided by the Medtronic CareLink™ Network. In some examples, server 94 may communicate with computing device 100 via network 92. For example, server 94 may communicate an analysis of data, such as determination of whether body temperature of the patient 14 and / or sensed activity of the patient 14 indicates an initial determination that patient has a UTI and / or determination / confirmation the patient has the UTI based, at least in part, on received patient inputs to questions regarding patient symptoms, to computing device 100, external device 12, or any other computing device via network 92.

[0061] In the example illustrated by FIG. 5, server 94 includes a storage device 96, e.g., to store data retrieved from IMD 10, and processing circuitry 98. Although not illustrated in FIG. 5 computing devices 100 may similarly include a storage device and processing circuitry. Processing circuitry 98 may include one or more processors that are configured to implement functionality and / or process instructions for execution within server 94. For example, processing circuitry 98 may be capable of processing instructions stored in memory 96. Processing circuitry 98 may include or be coupled to communication circuitry that may include any suitable hardware, firmware, software or any combination thereof for communicating with another device. In some examples, a description of processing circuitry 98 outputting a signal, such as a classification, may include processing circuitry 98 causing communication circuitry of server 94 to output the signal. Processing circuitry 98 may include, for example, microprocessors, DSPs, ASICs, FPGAs, or equivalent discrete or integrated logic circuitry, or a combination of any of the foregoing devices or circuitry. Accordingly, processing circuitry 98 may include any suitable structure, whether in hardware, software, firmware, or any combination thereof, to perform the functions ascribed herein to processing circuitry 98. Processing circuitry 98 of server 94 and / or the processing circuity of computing devices 100 may implement any of the techniques described herein to determine the onset or presence of a UTI in a patient based at least in part on data collected by an accelerometer 62A and a temperature sensor62B of an implantable medical device system, and responsively prompting the patient with questions regarding patient symptoms to determine / confirm the presence of the UTI in the patient based at least in part on patient inputs received in response to the respective questions.

[0062] Storage device 96 may include a computer-readable storage medium or computer-readable storage device. In some examples, memory 96 includes one or more of a short-term memory or a long-term memory. Storage device 96 may include, for example, RAM, DRAM, SRAM, magnetic discs, optical discs, flash memories, or forms of EPROM or EEPROM. In some examples, storage device 96 is used to store data indicative of instructions for execution by processing circuitry 98.

[0063] Although the techniques for determining the onset or presence of a UTI in a patient based at least in part on data collected by an accelerometer 62A and a temperature sensor 62B of an implantable medical device system, and responsively prompting the patient with questions regarding patient symptoms to determine / confirm the presence of the UTI in the patient based at least in part on patient inputs received in response to the respective questions, are described herein primarily as being performed by processing circuitry 50 of IMD 10, such techniques may be performed, in whole or part, by processing circuitry of any one or more devices of system 2, such as processing circuitry 80 of external device 12, processing circuitry 98 of server 94, or processing circuitry of one or more computing devices 100.

[0064] FIG. 6 is a flow diagram illustrating an example method for determining the onset or presence of a UTI in a patient based at least in part on data collected by an accelerometer 62A and a temperature sensor 62B of an implantable medical device system, and responsively prompting the patient with questions regarding patient symptoms to determine / confirm the presence of the UTI in the patient based at least in part on patient inputs received in response to the respective questions, in accordance with techniques of this disclosure.

[0065] As indicated by FIG. 6, processing circuitry 50 may generate, based at least on sensed activity of patient 4 or body temperature of patient 4, an initial determination that the patient 4 has a UTI (600). In some examples, IMD 10 includes sensor(s) 62, such as a temperature sensor 62B configured to sense body temperature of a patient and an accelerometer 62A configured to sense activity of the patient 4. In some examples,processing circuitry 50 may generate the initial determination that the patient 4 has a UTI based on the sensed activity of patient 4 and the body temperature of patient 4.

[0066] In some examples, processing circuitry 50 may determine, based at least in part on the sensed activity of the patient, a baseline amount of nighttime bathroom trips for the patient and may determine, based at least in part on the sensed activity of the patient during a particular period of time, an amount of nighttime bathroom trips for the patient for the particular period of time, and may determine a difference between the amount of nighttime bathroom trips for the particular period of time and the baseline amount of nighttime bathroom trips. In some examples, processing circuitry 50 may determine whether the determined difference between the amount of nighttime bathroom trips for the particular period of time and the baseline amount of nighttime bathroom trips satisfies a UTI increased bathroom trip threshold for the particular period of time.

[0067] In some examples, processing circuitry 50 may determine, based on sensed body temperature during the particular period of time, whether patient has a fever during the particular period of time. In some examples, processing circuitry 50 may determine whether the sensed body temperature during the particular period of time satisfies a UTI fever threshold.

[0068] In some examples, in response to a determination that the determined difference between the amount of nighttime bathroom trips for the particular period of time and the baseline amount of nighttime bathroom trips satisfies the UTI increased bathroom trip threshold for the particular period of time and the determination that the patient has a fever for the particular period of time, processing circuitry 50 may generate the initial determination that patient has the UTI.

[0069] In some examples, in response to a determination that the determined difference between the amount of nighttime bathroom trips for the particular period of time and the baseline amount of nighttime bathroom trips satisfies the UTI increased bathroom trip threshold for the particular period of time and the determination that the sensed body temperature during the particular period of time satisfies the UTI fever threshold, processing circuitry 50 may generate an initial determination that patient has the UTI.

[0070] In response to the generation of the initial determination that the patient has a UTI, processing circuitry 50 may cause computing device 12 to generate an output requesting the patient 4 provide one or more patient inputs to respective questionsregarding patient symptoms (602). In some examples, processing circuitry 50 may automatically cause computing device 12 to generate an output requesting the patient 4 provide one or more patient inputs to respective questions regarding patient symptoms in response to the generation of the initial determination that the patient has a UTI. In some examples, the respective questions may correspond or relate to one or more of the sensed activity of the patient or the sensed body temperature.

[0071] Processing circuitry 50 may receive one or more patient inputs (604).Processing circuitry 50 may determine / confirm the patient has the UTI based, at least in part, on the received patient inputs (606). Processing circuitry 50 may cause computing device 12 to generate an output indicating whether the patient is determined / confirmed to have the UTI and / or treatment instructions (608). For example, in response to a determination the patient has the UTI based, at least in part, on the received patient inputs, processing circuitry 50 cause computing device 12 to generate an output including one or more of: an urgent notification that the patient has the UTI, a notification to patient 4 to seek medical attention; and / or an indication to patient to perform a treatment, such as instructions on medication for patient 4 to take. In some examples, the outputs may be sent to other computing devices, such as computing devices of caregivers. For example, computing device 12 may generate an of an urgent notification that the patient has the UTI to be sent to a computing device of a caregiver, such as a nurse, clinician, family member, etc.

[0072] In some examples, processing circuitry 50 may cause computing device 12 to generate an output and await a response, such as a response input by patient 4, from computing device 12 over a period of time, such as a response threshold period of time. In some examples, if processing circuitry 50 does not determine a response has been received within the response threshold period of time or within a threshold amount of outputs (e.g., such as, but not limited to, up to six notifications having been sent to patient over a period of time, such as up to 12 hours, and no response from the computing device of the patient has been received) generated by computing device 12, processing circuitry 50 may cause an output be sent to a computing device of an alert caregiver. In some examples, processing circuitry 50 may additionally or alternatively send a confirmation request to patient 4 to confirm, such as by patient input, that a patient computing device received a UTI indication such as an indication that patient 4 has a UTI, to see a care provider, anindication to go to an emergency room, and / or an indication to proceed with a treatment, such as taking a particular medication. In some examples, if processing circuitry 50 does not determine a confirmation has been received from the patient within a threshold period of time and / or within a threshold amount of confirmation requests being sent over a period of time, processing circuitry 50 may cause an output be sent to a computing device of an alert caregiver. For example, computing device 12 may generate an of an urgent notification that the patient has the UTI to be sent to a computing device of a caregiver, such as a nurse, clinician, family member, etc.

[0073] The following examples are illustrative of the techniques described herein.

[0074] Example 1: A system includes an implantable medical device (IMD) includes a temperature sensor configured to sense body temperature of a patient, and an accelerometer configured to sense activity of the patient; and processing circuitry configured to: generate an initial determination, based at least in part on one or more of the sensed activity of the patient and the sensed body temperature, the patient has a urinary tract infection (UTI), in response to the initial determination that the patient has the UTI, cause a computing device to generate an output requesting the patient provide one or more patient inputs to respective questions regarding patient symptoms, receive the one or more patient inputs, and determine the patient has the UTI based, at least in part, on the received patient inputs.

[0075] Example 2: The system of example 1, wherein the processing circuitry is configured to generate the initial determination that the patient has the UTI based at least in part on the sensed activity of the patient and the sensed body temperature.

[0076] Example 3: The system of any of examples 1-2, wherein to generate the initial determination that the patient has the UTI based at least in part on the sensed activity of the patient the processing circuitry is configured to: determine, based at least in part on the sensed activity of the patient, a baseline amount of nighttime bathroom trips for the patient; determine, based at least in part on the sensed activity of the patient during a particular period of time, an amount of nighttime bathroom trips for the patient for the particular period of time; determine a difference between the amount of nighttime bathroom trips for the particular period of time and the baseline amount of nighttime bathroom trips; and determine whether the determined difference between the amount of nighttime bathroom trips for the particular period of time and the baseline amount ofnighttime bathroom trips satisfies a UTI increased bathroom trip threshold for the particular period of time.

[0077] Example 4: The system of example 3, wherein to generate the initial determination that the patient has the UTI based at least in part on the sensed body temperature of the patient the processing circuitry is configured to: determine, based on sensed body temperature during the particular period of time, whether the patient has a fever during the particular period of time.

[0078] Example 5: The system of example 4, wherein to generate the initial determination that the patient has the UTI based at least in part on the sensed activity of the patient and the sensed body temperature of the patient the processing circuitry is configured to: in response to a determination that the determined difference between the amount of nighttime bathroom trips for the particular period of time and the baseline amount of nighttime bathroom trips satisfies the UTI increased bathroom trip threshold for the particular period of time and the determination that the patient has a fever for the particular period of time, generating the initial determination that patient has the UTI.

[0079] Example 6: The system of example 3, wherein to generate the initial determination that the patient has the UTI based at least in part on the sensed body temperature of the patient the processing circuitry is configured to: determine whether the sensed body temperature during the particular period of time satisfies a UTI fever threshold.

[0080] Example 7: The system of any of examples 1-6, wherein to generate the initial determination that the patient has the UTI based at least in part on the sensed activity of the patient and the sensed body temperature of the patient the processing circuitry is configured to: in response to a determination that the determined difference between the amount of nighttime bathroom trips for the particular period of time and the baseline amount of nighttime bathroom trips satisfies the UTI increased bathroom trip threshold for the particular period of time and the determination that the sensed body temperature during the particular period of time satisfies the UTI fever threshold, generating the initial determination that patient has the UTI.

[0081] Example 8 : The system of any of examples 1-7, wherein the respective questions correspond to one or more of the sensed activity of the patient or the sensed body temperature.

[0082] Example 9: The system of any of examples 1-8, wherein the processing circuitry is further configured to automatically cause the computing device to generate the output requesting the patient provide one or more patient inputs to respective questions regarding patient symptoms in response to the initial determination that the patient has the UTI.

[0083] Example 10: The system of any of examples 1-9, wherein the processing circuitry is further configured to, in response to a determination the patient has the UTI based, at least in part, on the received patient inputs, cause the computing device to generate an output including one or more of: an indication that the patient has the UTI; a prompt to the patient to seek medical attention; a confirmation request to the patient to confirm receipt; or an indication to patient to perform a treatment.

[0084] Example 11: The system of example 10, wherein the indication to patient to perform a treatment includes instructions on medication for patient to take.

[0085] Example 12: The system of any of examples 1-11, wherein the processing circuitry is located in the implantable medical device.

[0086] Example 13: The system of any of examples 1-12, wherein the implantable medical device is an insertable cardiac monitor (ICM) further includes a housing configured for subcutaneous implantation within a patient; and a plurality of electrodes on the housing, wherein the ICM is configured to sense a cardiac electrogram (EGM) of the patient via the plurality of electrodes; a power source operatively coupled to the processing circuitry; a memory operatively coupled to the processing circuitry; and wherein the plurality of electrodes are operatively coupled to the processing circuitry, wherein the housing is a hermetically- sealed housing, wherein at least the power source, memory, and processing circuitry are within the hermetically- sealed housing, and wherein the housing has a length, a width, and a depth, wherein the length is greater than the width and the width is greater than the depth, wherein the length is within a range from 5 millimeters (mm) to 60 mm, wherein the width is within a range from 5 mm to 15 mm, and wherein the depth is within a range from 5 mm to 15 mm.

[0087] Example 14: A method for determining a patient has a urinary tract infection (UTI) includes sensing, by an implantable medical device (IMD), one or more of activity of the patient or body temperature of the patient; generating, by processing circuitry, an initial determination the patient has the UTI based at least in part on one or more of the sensed activity of the patient and the sensed body temperature; in response to the initialdetermination that the patient has the UTI, causing, by the processing circuitry, a computing device to generate an output requesting the patient provide one or more patient inputs to respective questions regarding patient symptoms; receiving, by the processing circuitry, the one or more patient inputs; and determining, by the processing circuitry, the patient has the UTI based, at least in part, on the received patient inputs.

[0088] Example 15: The method of example 14, wherein the method is configured to generate the initial determination that the patient has the UTI based at least in part on sensed activity of the patient and sensed body temperature.

[0089] Example 16: The method of any of examples 14-15, wherein to generate the initial determination that the patient has the UTI based at least in part on the sensed activity of the patient the method further comprises: determining, based at least in part on sensed activity of the patient, a baseline amount of nighttime bathroom trips for the patient; determining, based at least in part on sensed activity of the patient during a particular period of time, an amount of nighttime bathroom trips for the patient for the particular period of time; determining a difference between the amount of nighttime bathroom trips for the particular period of time and the baseline amount of nighttime bathroom trips; and determining whether the determined difference between the amount of nighttime bathroom trips for the particular period of time and the baseline amount of nighttime bathroom trips satisfies a UTI increased bathroom trip threshold for the particular period of time.

[0090] Example 17: The method of example 16, wherein to generate the initial determination that the patient has the UTI based at least in part on the sensed body temperature of the patient the method further comprises: determining, based on sensed body temperature during the particular period of time, whether the patient has a fever during the particular period of time.

[0091] Example 18: The method of example 17, to generate the initial determination that the patient has the UTI based at least in part on the sensed activity of the patient and the sensed body temperature of the patient the method further comprises: in response to a determination that the determined difference between the amount of nighttime bathroom trips for the particular period of time and the baseline amount of nighttime bathroom trips satisfies the UTI increased bathroom trip threshold for the particular period of time and thedetermination that the patient has a fever for the particular period of time, generating an initial determination that patient has the UTI.

[0092] Example 19: The method of example 16, wherein to generate the initial determination that the patient has the UTI based at least in part on the sensed body temperature of the patient the method further comprises: determining whether the sensed body temperature during the particular period of time satisfies a UTI fever threshold.

[0093] Example 20: The method of example 19, to generate the initial determination that the patient has the UTI based at least in part on the sensed activity of the patient and the sensed body temperature of the patient the method further comprises: in response to a determination that the determined difference between the amount of nighttime bathroom trips for the particular period of time and the baseline amount of nighttime bathroom trips satisfies the UTI increased bathroom trip threshold for the particular period of time and the determination that the sensed body temperature during the particular period of time satisfies the UTI fever threshold, generating the initial determination that patient has the UTI.

[0094] Example 21: The method of any of examples 14-20, wherein the respective questions correspond to one or more of the sensed activity of the patient or the sensed body temperature.

[0095] Example 22: The method of any of examples 14-21, the method further includes automatically causing, by the circuitry, the computing device to generate the output requesting the patient provide one or more patient inputs to respective questions regarding patient symptoms in response to the initial determination that the patient has the UTI.

[0096] Example 23: The method of any of examples 14-22, the method further includes in response to a determination the patient has the UTI based, at least in part, on the received patient inputs, causing the computing device to generate an output including one or more of: an indication that the patient has the UTI; a prompt to the patient to seek medical attention; a confirmation request to the patient to confirm receipt; or an indication to patient to perform a treatment.

[0097] Example 24: The method of example 23, wherein the indication to patient to perform a treatment includes instructions on medication for patient to take.

[0098] Example 25: A non-transitory computer-readable storage medium storing instructions, which when executed, cause processing circuitry to execute any of the methods recited in examples 14-24.

[0099] Various examples have been described. These and other examples are within the scope of the following claims.

Claims

WHAT IS CLAIMED IS:

1. A system comprising: an implantable medical device (IMD) comprising: a temperature sensor configured to sense body temperature of a patient, and an accelerometer configured to sense activity of the patient; and processing circuitry configured to: generate an initial determination, based at least in part on one or more of the sensed activity of the patient and the sensed body temperature, the patient has a urinary tract infection (UTI), in response to the initial determination that the patient has the UTI, cause a computing device to generate an output requesting the patient provide one or more patient inputs to respective questions regarding patient symptoms, receive the one or more patient inputs, and determine the patient has the UTI based, at least in part, on the received patient inputs.

2. The system of claim 1, wherein the processing circuitry is configured to generate the initial determination that the patient has the UTI based at least in part on the sensed activity of the patient and the sensed body temperature.

3. The system of any of claims 1-2, wherein to generate the initial determination that the patient has the UTI based at least in part on the sensed activity of the patient the processing circuitry is configured to:determine, based at least in part on the sensed activity of the patient, a baseline amount of nighttime bathroom trips for the patient; determine, based at least in part on the sensed activity of the patient during a particular period of time, an amount of nighttime bathroom trips for the patient for the particular period of time; determine a difference between the amount of nighttime bathroom trips for the particular period of time and the baseline amount of nighttime bathroom trips; and determine whether the determined difference between the amount of nighttime bathroom trips for the particular period of time and the baseline amount of nighttime bathroom trips satisfies a UTI increased bathroom trip threshold for the particular period of time.

4. The system of claim 3, wherein to generate the initial determination that the patient has the UTI based at least in part on the sensed body temperature of the patient the processing circuitry is configured to: determine, based on sensed body temperature during the particular period of time, whether the patient has a fever during the particular period of time.

5. The system of claim 4, wherein to generate the initial determination that the patient has the UTI based at least in part on the sensed activity of the patient and the sensed body temperature of the patient the processing circuitry is configured to: in response to a determination that the determined difference between the amount of nighttime bathroom trips for the particular period of time and the baseline amount of nighttime bathroom trips satisfies the UTI increased bathroom trip threshold for the particular period of time and the determination that the patient has a fever for the particular period of time, generating the initial determination that patient has the UTI.

6. The system of claim 3, wherein to generate the initial determination that the patient has the UTI based at least in part on the sensed body temperature of the patient the processing circuitry is configured to: determine whether the sensed body temperature during the particular period of time satisfies a UTI fever threshold.

7. The system of any of claims 1-6, wherein to generate the initial determination that the patient has the UTI based at least in part on the sensed activity of the patient and the sensed body temperature of the patient the processing circuitry is configured to: in response to a determination that the determined difference between the amount of nighttime bathroom trips for the particular period of time and the baseline amount of nighttime bathroom trips satisfies the UTI increased bathroom trip threshold for the particular period of time and the determination that the sensed body temperature during the particular period of time satisfies the UTI fever threshold, generating the initial determination that patient has the UTI.

8. The system of any of claims 1-7, wherein the respective questions correspond to one or more of the sensed activity of the patient or the sensed body temperature.

9. The system of any of claims 1-8, wherein the processing circuitry is further configured to automatically cause the computing device to generate the output requesting the patient provide one or more patient inputs to respective questions regarding patient symptoms in response to the initial determination that the patient has the UTI.

10. The system of any of claims 1-9, wherein the processing circuitry is further configured to, in response to a determination the patient has the UTI based, at least in part, on the received patient inputs, cause the computing device to generate an output including one or more of: an indication that the patient has the UTI; a prompt to the patient to seek medical attention; a confirmation request to the patient to confirm receipt; or an indication to patient to perform a treatment.

11. The system of claim 10, wherein the indication to patient to perform a treatment includes instructions on medication for patient to take.

12. The system of any of claims 1-11, wherein the processing circuitry is located in the implantable medical device.

13. The system of any of claims 1-12, wherein the implantable medical device is an insertable cardiac monitor (ICM) further comprising: a housing configured for subcutaneous implantation within a patient; and a plurality of electrodes on the housing, wherein the ICM is configured to sense a cardiac electrogram (EGM) of the patient via the plurality of electrodes; a power source operatively coupled to the processing circuitry; a memory operatively coupled to the processing circuitry; and wherein the plurality of electrodes are operatively coupled to the processing circuitry, wherein the housing is a hermetically- sealed housing, wherein at least the power source, memory, and processing circuitry are within the hermetically-sealed housing, and wherein the housing has a length, a width, and a depth, wherein the length is greater than the width and the width is greater than the depth, wherein the length is within a range from 5 millimeters (mm) to 60 mm, wherein the width is within a range from 5 mm to 15 mm, and wherein the depth is within a range from 5 mm to 15 mm.

14. A non-transitory computer-readable storage medium storing instructions, which when executed, cause processing circuitry to execute: sensing, by an implantable medical device (IMD), one or more of activity of the patient or body temperature of the patient; generating an initial determination the patient has the UTI based at least in part on one or more of the sensed activity of the patient and the sensed body temperature; in response to the initial determination that the patient has the UTI, causing a computing device to generate an output requesting the patient provide one or more patient inputs to respective questions regarding patient symptoms;receiving the one or more patient inputs; and determining the patient has the UTI based, at least in part, on the received patient inputs.

15. The non-transitory computer-readable storage medium of claim 14, wherein to generate the initial determination that the patient has the UTI based at least in part on the sensed activity of the patient, the instructions further cause the processing circuitry to execute: determining, based at least in part on sensed activity of the patient, a baseline amount of nighttime bathroom trips for the patient; determining, based at least in part on sensed activity of the patient during a particular period of time, an amount of nighttime bathroom trips for the patient for the particular period of time; determining a difference between the amount of nighttime bathroom trips for the particular period of time and the baseline amount of nighttime bathroom trips; and determining whether the determined difference between the amount of nighttime bathroom trips for the particular period of time and the baseline amount of nighttime bathroom trips satisfies a UTI increased bathroom trip threshold for the particular period of time.

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