Dynamic implant telemetry control for setup

Abstract

An implantable medical device includes communication circuitry configured for wireless communication according to a radio frequency (RF) communication protocol; and processing circuitry configured to: determine that the HMD received a wakeup signal; responsive to determining that the IMD received the wakeup signal, control the communication circuitry to broadcast advertisements at a first advertising rate for a period of time using the RF communication protocol, the period of time being at least 8 hours; determine that a communication session was not established with an external device within the period of time; and responsive to determining that the communication session was not established with the external device, control the communication circuitry to change the first advertising rate of the advertisements.

Description

Docket No.: A0012443W001 / 1123-844W001 DYNAMIC IMPLANT TELEMETRY CONTROL FOR SETUP

[0001] This application is a PCT application that claims priority to, and the benefit of, U.S. Provisional Patent Application No. 63 / 749,379, filed January 24, 2025, the entire contents of which is incorporated herein by reference.TECHNICAL FIELD

[0002] This disclosure generally relates to medical devices and, more particularly, establishing communications with medical devices.BACKGROUND

[0003] Medical devices may be external or implanted and may be used to deliver electrical stimulation therapy to various tissue sites of a patient to treat a variety of symptoms or conditions such as chronic pain, tremor, Parkinson’s disease, other movement disorders, epilepsy, urinary or fecal incontinence, sexual dysfunction, obesity, or gastroparesis. A medical device may deliver electrical stimulation therapy via one or more leads that include electrodes located proximate to target locations associated with the brain, the spinal cord, pelvic nerves, peripheral nerves, or the gastrointestinal tract of a patient. Hence, electrical stimulation may be used in different therapeutic applications, such as deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, or peripheral nerve field stimulation (PNFS). An external programmer may be used to program a medical device or retrieve information from the medical device.SUMMARY

[0004] In general, the disclosure describes devices, systems, and techniques for dynamically adjusting an advertising rate during different periods of the device lifetime, such as during initial setup of a medical device for implantation in a patient. In some examples, an implantable medical device (IMD) is configured to receive a signal, such as a wakeup signal, and responsively controls communication circuitry of the IMD to broadcast advertisements at a first advertising rate for a period of time using a radio frequency (RF) communication protocol, e.g., a Bluetooth™ Low Energy (BLE) protocol. This period of time may be from 8 hours to 48 hours in some examples. In this manner, the IMD may operate with the first advertising rate for the period of time unless an intervening action occurs that triggers the IMD to change the advertising rate again.Docket No.: A0012443W001 / 1123-844W001

[0005] The IMD may receive the wakeup signal via telemetry circuitry of the IMD, and the wakeup signal may be an inductive signal, RF signals, some other wireless signal, or a mechanical vibration that can trigger an electrical circuit. The IMD may, in response to receiving the wakeup signal, close a battery switch to enable increased (or full) operational power to be delivered from a battery of the IMD to circuitry of the IMD. If the IMD determines a communication session was not established with an external device, e.g., a patient programmer and / or a clinician programmer, the IMD can change the first advertising rate of the advertisements. Changing the first advertising rate of the advertisements may include slowing the advertising rate or even stopping the advertisements completely. In some examples, to stop the advertisements, the IMD can open the battery switch of the IMD which ceases power to the telemetry circuitry. If the IMD determines a communication session was established with the external device, the IMD can restart the period of time to extend operation using the first advertising rate. In some examples, the IMD is configured to receive user-specific configuration instructions for configuring the IMD during the communication session and before implantation of IMD.

[0006] In some examples, an IMD configured with the user-specific configuration may not end up being implanted into the intended patient. The patient may not be able to undergo the implantation procedure or otherwise decide not to proceed with the implantation of the IMD. In such examples, the IMD may be configured to automatically erase the stored user-specific configuration in response to the period of time elapsing after the user-specific configuration instructions were received. The IMD may additionally open the battery switch. In this manner, the IMD may automatically revert to a stored state where the IMD is clear of any user-specific information and ready to be configured for a different patient if needed.

[0007] In some examples, the first advertising rate may be greater than a second advertising rate associated with baseline IMD operation. The first advertising rate may also be less than a third advertising rate associated with an interrogation operation of the IMD. The first advertising rate may be between 0.5 Hertz (Hz) and 10 Hz in some examples.. The second advertising rate may be less than 0.5 Hz, and the third advertising rate may be between 10 Hz and 50 Hz, for example.

[0008] In one example, an IMD includes communication circuitry configured for wireless communication according to a radio frequency (RF) communication protocol; and processing circuitry configured to: determine that the IMD received a wakeup signal; responsive to determining that the IMD received the wakeup signal, control the communication circuitry to broadcast advertisements at a first advertising rate for a period of time using the RF communication protocol, the period of time being at least 8 hours; determine that aDocket No.: A0012443W001 / 1123-844W001 communication session was not established with an external device within the period of time; and responsive to determining that the communication session was not established with the external device, control the communication circuitry to change the first advertising rate of the advertisements.

[0009] In another examples, a method includes: determining, by processing circuitry of an implantable medical device (IMD), that the IMD received a wakeup signal; controlling, by the processing circuitry and response to determining that the IMD received the wakeup signal, communication circuitry of the IMD to broadcast advertisements at a first advertising rate for a period of time using a radio frequency (RF) communication protocol, the period of time being at least 8 hours; determining, by the processing circuitry, that a communication session was not established with an external device within the period of time; and controlling, by the processing circuitry and responsive to determining that the communication session was not established with the external device within the period of time, the communication circuitry to change the first advertising rate of the advertisements.

[0010] In another example, a non-transitory computer-readable medium storing instructions that when executed cause processing circuitry to: determine that an implantable medical device (IMD) comprising the processing circuitry received a wakeup signal; responsive to determining that the IMD received the wakeup signal, control communication circuitry of the IMD configured for wireless communication according to a radio frequency (RF) protocol to broadcast advertisements at a first advertising rate for a period of time using the RF communication protocol, the period of time being at least 8 hours; determine that a communication session was not established with an external device within the period of time; and responsive to determining that the communication session was not established with the external device, control the communication circuitry to change the first advertising rate of the advertisements.

[0011] The details of one or more examples of the techniques of this disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0012] FIG. l is a conceptual diagram illustrating an example system that manages delivery of neurostimulation to a patient to manage bladder dysfunction, such as overactive bladder, urgency, or urinary incontinence according to an example of the techniques of the disclosure.

[0013] FIG. 2 is a block diagram illustrating an example configuration of the implantable medical device (IMD) of FIG. 1 according to an example of the techniques of the disclosure.Docket No.: A0012443W001 / 1123-844W001

[0014] FIG. 3 is a block diagram illustrating an example configuration of the external device of FIG. 1 according to an example of the techniques of the disclosure.

[0015] FIG. 4 is a conceptual diagram illustrating an example home screen for navigating within a user interface according to an example of the techniques of the disclosure.

[0016] FIG. 5 is a conceptual diagram illustrating an example screen for selecting an IMD for setup according to an example of the techniques of the disclosure.

[0017] FIG. 6 is a conceptual diagram illustrating an example screen for setting up one or more user specific configurations of an IMD according to an example of the techniques of the disclosure.

[0018] FIG. 7 is a conceptual diagram illustrating an example screen for setting one or more therapy program parameters according to an example of the techniques of the disclosure.

[0019] FIG. 8 is a conceptual diagram illustrating an example pop-up window for starting a service life of an IMD according to an example of the techniques of the disclosure.

[0020] FIG. 9 is a flowchart illustrating an example operation for dynamically adjusting an advertising rate of an IMD according to an example of the techniques of the disclosure.

[0021] FIG. 10 is a flowchart illustrating an example operation for dynamically adjusting an advertising rate of an IMD at various before and after starting a service life of the IMD according to an example of the techniques of the disclosure.DETAILED DESCRIPTION

[0022] This disclosure describes example devices, systems, and techniques for dynamically adjusting an advertising rate for a medical device. This dynamic adjustment of advertisement rate for establishing communication can be used during setup of a medical device, such as an implantable medical device configured to deliver electrical stimulation therapy. Implantable medical devices (HMDs) are often shipped in a low power state to prevent battery power consumption during shipment and storage. This low power state may be a completely shut down state where no power is used or a “sleep state” where a very low level of power is drawn from the battery.

[0023] Prior to programming, implanting, and / or otherwise using the IMD, a user may need to transition the IMD out of the low power state in a sterile operating room to prepare the IMD for implantation and subsequent use with a patient. To transition the IMD out of the lower power state, the user may use an external device to transmit an inductive activation signal. The IMD may receive the activation signal and responsively change to a higher power state, establish communication, etc. As an example, the IMD may, via telemetry circuitry of the IMD, receive an inductive, proximal activation signal from an external device, such as a programming device.Docket No.: A0012443W001 / 1123-844W001 After activating the IMD, the external device may wakeup the IMD via a proximal wakeup signal, which may cause the IMD to temporarily broadcast advertisements at, as an example, between 10 Hertz (Hz) and 50 Hz for a period of time, e.g., 10 seconds or 1 minute, which enables the IMD to establish a communication session with an external device. While this configuration allows the user to wirelessly connect the IMD to the programming device (an external device), the proximity requirement for the wakeup signal may require that the external device is within the sterile operating room or within the sterile field during operation. This situation requires that the external device also be sterile, and it requires time for waking up the IMD in the presence of the clinician and other healthcare professionals.

[0024] As described herein, the techniques of this disclosure may obviate the need for waking up the IMD with the external device in the sterile operating room. As an example, the techniques of this disclosure may include a system including an external device (e.g., an external programmer or other programming device) configured to send a wakeup signal to the IMD that activates the IMD and causes the IMD to advertise at a first advertising rate for a relatively long period of time, such as between 8 hours and 48 hours. This relatively long period of time enables the IMD to prepared for use hours or even days prior to being delivered to the operating room. In some examples, the first advertising rate may be between 0.5 Hz and 10 Hz. The IMD may advertise using a radio frequency (RF) communication protocol, e.g., a Bluetooth™ Low Energy (BLE) protocol, to establish a communication session with the programming device, e.g., a patient programmer and / or a clinician programmer. The first advertising rate may be greater than a second advertising rate associated with baseline IMD operation and less than a third advertising rate associated with an interrogation operation of the IMD.

[0025] In some examples, the IMD receives the wakeup signal via telemetry circuitry of the IMD. The wakeup signal may be an inductive signal that powers the telemetry circuitry of the IMD without the IMD needing internal power at that time. In some examples, the IMD may also close a battery switch to enable full operation power from a battery of the IMD in response to receiving the wakeup signal. If the IMD determines a communication session was not established with an external device, e.g., a patient programmer and / or a clinician programmer, the IMD determines to change the first advertising rate of the advertisements. In some examples, changing the first advertising rate of the advertisements includes stopping the advertisements. In some examples, to stop the advertisements, the IMD opens the battery switch of the IMD. If the IMD determines a communication session was established with the external device, the IMD restarts the period of time. In this manner, continued interaction with the IMD can prevent the IMD from returning to the low power state. In some examples, the IMD is configured to receive userDocket No.: A0012443W001 / 1123-844W001 specific configuration instructions for configuring the IMD during the communication session and before implantation of IMD.

[0026] These various features of the devices, systems, and techniques described herein may provide advantages over other systems and improve system functionality and patient outcomes. For example, by advertising at the first advertising rate for the period of time, the techniques of this disclosure may reduce a complexity of activating and setting up the IMD in the presence of the clinician and patient, which may streamline setup of the IMD and reduce clinician time. As an example, the techniques of this disclosure may allow the user to, during the communication session, provide instructions for configuring one or more of one or more therapy program parameters or a therapy schedule for a patient. In some examples, the user may be able to provide instructions for configuring one or more therapy program parameters and / or a therapy schedule for the patient before starting a service life of the IMD. The system may erase the instructions if the IMD is not implanted within the period of time. Additionally, the techniques of this disclosure may reduce the number of devices that are in a sterile operating room during implantation of the IMD (e.g., the wakeup device can be used previously), which may reduce a complexity of the operation. Limiting the number of devices in the operating room may additionally facilitate more efficient implantation of the IMD, which may reduce an amount of time that a patient and clinician spend in the operating room.

[0027] FIG. 1 is a conceptual diagram illustrating an example system 10 that manages delivery of neurostimulation to a patient 14 to manage bladder dysfunction, such as overactive bladder, urgency, or urinary incontinence according to an example of the techniques of the disclosure. As shown in the example of FIG. 1, therapy system 10 includes IMD 16 (e.g., an example medical device), which is coupled to sensor 210 (e.g., an internal sensor 210 and / or external wearable sensor 15) and one or more of lead 28. System 10 additionally includes an external device 24, which is configured to communicate with IMD 16 via wireless communication. System 10 may include server 26, which may be one or more servers in a cloud computing environment. Server 26 may be configured to communicate with external device 24 and / or IMD 16 via wireless communication through a network access point (not shown in FIG. 1) and may be collocated with external device 24 or may be located elsewhere, such as in a cloud computing data center. IMD 16 generally operates as a therapy device that delivers neurostimulation (e.g., electrical stimulation in the example of FIG. 1) to, for example, a target tissue site proximate a spinal nerve, a sacral nerve, a pudendal nerve, dorsal genital nerve, a tibial nerve, a saphenous nerve, an inferior rectal nerve, a perineal nerve, or other pelvic nerves, branches of any of the aforementioned nerves, roots of any of the aforementioned nerves, ganglia of any of the aforementioned nerves, or plexus of any of the aforementioned nerves. IMD 16Docket No.: A0012443W001 / 1123-844W001 provides electrical stimulation to patient 14 by generating and delivering a programmable electrical stimulation signal (e.g., in the form of electrical pulses or an electrical waveform) to a target a therapy site near lead 28 and, more particularly, near electrodes 29 (electrodes 29A-29D of FIG. 2, collectively referred to as “electrodes 29”) disposed proximate to a distal end of lead 28. Electrodes 29 may be positioned near target tissue, such as a target nerve such as a sacral nerve. Lead 28 may be inserted through any portion of tissue, such as foramen 27 within sacrum 26 as shown in the example of FIG. 1. Although described with respect to IMD 16 and bladder dysfunction management, the techniques of this disclosure are not so limited. The techniques of this disclosure may be implemented using a plurality of different types of medical devices, such as any IMD configured to deliver electrical stimulation therapy.

[0028] IMD 16 may be surgically implanted in patient 14 at any suitable location within patient 14, such as near the pelvis. In some examples, IMD 16 may be implanted in a subcutaneous location in the side of the lower abdomen or the side of the lower back or upper buttocks. IMD 16 has a biocompatible housing, which may be formed from titanium, stainless steel, a liquid crystal polymer, or the like. The proximal ends of lead 28 is both electrically and mechanically coupled to IMD 16 either directly or indirectly, e.g., via a respective lead extension. Electrical conductors disposed within the lead bodies of lead 28 electrically connect electrodes 29 to sensing circuitry and stimulation delivery circuitry (e.g., a stimulation generator) within IMD 16. In some examples, system 10 may include other electrode, a strain gauge, one or more accelerometers, ultrasound sensors, optical sensors, or any other sensor. In some examples, the sensors may be configured to gather information relating to the patient, such as detect contractions of bladder 12, pressure or volume of bladder 12, or any other indication of the fill cycle of bladder 12 and / or possible bladder dysfunctional states. System 10 may use the sensor data for determining stimulation program settings for a given patient, as discussed below. IMD 16 may communicate sensed data to server 26. In some examples, IMD 16 may communicate the sensor data through external device 24. In other examples, IMD 16 may communicate the sensor data to server 26 without communicating the sensor data through external device 24.

[0029] In some examples, system 10 may not use any sensors at all. For example, external device 24 may collect user input identifying a voiding event, perceived level of fullness, or any other indication of an event associated with the patient. The user input may be in the form of a voiding journal analyzed by external device 24, IMD 16 or server 26, or individual user inputs associated with respective voiding events, leakage, or any other event related to the patient. External device 24 may provide this user input to server 26.

[0030] One or more medical leads, e.g., lead 28, may be connected to IMD 16 and surgically or percutaneously tunneled to place one or more electrodes carried by a distal end of theDocket No.: A0012443W001 / 1123-844W001 respective lead at a desired nerve or muscle site, e.g., one of the previously listed target therapy sites such as a tissue site proximate a spinal (e.g., sacral) or pudendal nerve. For example, lead 28 may be positioned such that electrodes 29 deliver electrical stimulation to a spinal, sacral or pudendal nerve to reduce a frequency and / or magnitude of contractions of bladder 12. Additional electrodes of lead 28 and / or electrodes of another lead may provide additional stimulation therapy to other nerves or tissues as well.

[0031] In the example shown in FIG. 1, lead 28 is cylindrical. Electrodes 29 may be ring electrodes, segmented electrodes, partial ring electrodes or any suitable electrode configuration. Segmented and partial ring electrodes each extend along an arc less than 360 degrees (e.g., 90-120 degrees) around the outer perimeter of lead 28. In some examples, segmented electrodes 29 of lead 28 may be useful for targeting different fibers of the same or different nerves to generate different physiological effects (e.g., therapeutic effects). In examples, one or more of lead 28 may be, at least in part, paddle-shaped (e.g., a “paddle” lead), and may include an array of electrodes on a common surface, which may or may not be substantially flat.

[0032] In some examples, one or more of electrodes 29 may be cuff electrodes that are configured to extend at least partially around a nerve (e.g., extend axially around an outer surface of a nerve). Delivering electrical stimulation via one or more cuff electrodes and / or segmented electrodes may help achieve a more uniform electrical field or activation field distribution relative to the nerve, which may help minimize discomfort to patient 14 that results from the delivery of electrical stimulation. An electrical field may define the volume of tissue that is affected when the electrodes 29 are activated. An activation field represents the neurons that will be activated by the electrical field in the neural tissue proximate to the activated electrodes.

[0033] The illustrated numbers and configurations of lead 28 and electrodes carried by lead 28 are merely exemplary. Other configurations, e.g., numbers and positions of leads and electrodes are also contemplated. For example, in other implementations, IMD 16 may be coupled to additional leads or lead segments having one or more electrodes positioned at different locations proximate the spinal cord or in the pelvic region of patient 14. The additional leads may be used for delivering different stimulation therapies or other electrical stimulations to respective stimulation sites within patient 14 or for monitoring at least one physiological marker of patient 14.

[0034] In accordance with some examples of the disclosure, IMD 16 delivers electrical stimulation to at least one of a spinal nerve (e.g., a sacral nerve), a pudendal nerve, dorsal genital nerve, a tibial nerve, a saphenous nerve, an inferior rectal nerve, or a perineal nerve to provide a therapeutic effect that reduces or eliminates a dysfunctional state such as overactive bladder. The desired therapeutic effect may be an inhibitory physiological response related to voiding ofDocket No.: A0012443W001 / 1123-844W001 patient 14, such as a reduction in bladder contraction frequency by a desired level or degree (e.g., percentage).

[0035] System 10 may also include an external device 24, as shown in FIG. 1. External device 24 may be an example of a computing device (such as computing devices 230A-230N shown in FIG. 4). In some examples, external device 24 may be a clinician programmer or patient programmer. In some examples, external device 24 may be a device for inputting patient specific configuration instructions for configuring IMD 16. In some examples, external device 24 may be a wearable communication device, with a therapy request input integrated into a key fob or a wristwatch, handheld computing device, smart phone, computer workstation, or networked computing device. External device 24 may include a user interface that is configured to receive input from a user (e.g., patient 14, a patient caretaker or a clinician). In some examples, the user interface includes, for example, a keypad and a display, which may for example, be a liquid crystal display (LCD) or light emitting diode (LED) display. In some examples, the user interface may include a turnable knob or a representation of a turnable knob. The keypad may take the form of an alphanumeric keypad or a reduced set of keys associated with particular functions. External device 24 may additionally or alternatively include a peripheral pointing device, such as a mouse, via which a user may interact with the user interface. In some examples, a display of external device 24 may include a touch screen display, and a user may interact with external device 24 via the display. It should be noted that the user may also interact with external device 24, server 26 and / or IMD 16 remotely via a networked computing device.

[0036] A user, such as a physician, technician, surgeon, electrophysiologist, or other clinician, may also interact with external device 24 or another separate programmer (not shown), such as a clinician programmer, to communicate with IMD 16 and / or server 26. Such a user may interact with external device 24 to retrieve physiological or diagnostic information from IMD 16. The user may also interact with external device 24 to program IMD 16, e.g., select values for the stimulation parameter values with which IMD 16 generates and delivers stimulation and / or the other operational parameters of IMD 16, such as magnitudes of stimulation energy, user requested periods for stimulation or periods to prevent stimulation, or any other such user customization of therapy. In some examples, the user can select values for the stimulation parameter values pre-operatively during an established communication session. In some examples, the user can additionally or alternatively select the values post-operatively. In some examples, the stimulation parameter values may be proposed by system 10, for example, by server 26 and a user may be able to accept or reject the stimulation parameter values. In other examples, the stimulation parameter values may be set by system 10, for example, by server 26.Docket No.: A0012443W001 / 1123-844W001 As discussed herein, the user may also provide input to external device 24 indicative of physiological events such as bladder fill level perception and void events.

[0037] In some examples, the user, such as a clinician or patient, may input information relating to patient 14 into external device 24 and external device 24 may collect first information relating to the patient and provide that information to server 26. The first information relating to a patient may include: 1) demographic information, such as gender, age, etc.; 2) medical history, such as BMI, diagnosis, comorbidities, medications, etc.; 3) baseline symptom data during a predetermined time period, such as somewhere in the range of three days to two weeks, for example. Baseline symptom data may include symptoms of a disease that the patient is experiencing. For example, baseline symptom data may include a number of or time when a patient experiences an incontinence issue or a feeling of urgency to urinate. Baseline symptom data may also include volume of a urinary event or other measures indicative of the symptoms the patient may be experiencing, for example, information relating to bowel movements, pain, etc. In some examples, the patient may be prompted by external device 24 to answer questions related to their medications, lifestyle and quality of life. These questions may include questions relating to length and quality of sleep, fluid intake, food intake, food choices, activities of daily life, level of activities (e.g., step counts), exercise, pain, discomfort, etc. In some examples, these questions may be asked periodically over a period of days, such as three to four days. In some examples, the user may provide the first information relating to a patient prior to beginning treatment, during a baseline period. In other examples, the first information related to the patient’s medications, lifestyle and quality of life may be gathered in another manner, such as entered by a clinician onto external device 24. In some examples, the user may provide further information relating to a patient during other periods. For example, external device 24 may prompt patient 14 to answer questions about their symptoms or the efficacy of treatment during the other periods. For example, external device 24 may prompt patient 14 to input whether patient 14 had a bladder leak that day or a number of times patient 14 had bladder leaks that day. External device 24 may collect the information relating to a patent and provide the information relating to the patient, including the answers to the questions, to server 26.

[0038] In some examples, a healthcare provider may utilize sensors, such as wearable sensor 15 or existing implanted sensors, to collect more objective patient data related to sleep, activity or disease symptoms. For example, wearable sensor 15 may be a heartrate sensor, an accelerometer and / or other sensor to collect patient data, for example, on disease symptoms or lifestyle. The patient data captured by the sensors, such as wearable sensor 15, may be provided to server 26. In some examples, the sensors, such as wearable sensor 15, may be configured to communicate with an external device, such as external device 24, via a wireless link. In someDocket No.: A0012443W001 / 1123-844W001 examples, external device 24 may collect the patient data generated by the sensors and send the patient data to server 26. In other examples, another device may collect the patient data generated by the sensors and send the patient data to server 26.

[0039] For example, the user may use external device 24 to retrieve information from IMD 16 relating to the contraction frequency of bladder 12 and / or voiding events. As another example, the user may use external device 24 to retrieve information from IMD 16 relating to the performance or integrity of IMD 16 or other components of system 10, such as lead 28, or a power source of IMD 16. In some examples, this information may be presented to the user as an alert if a system condition that may affect the efficacy of therapy is detected.

[0040] The user of external device 24 may also communicate with server 26. For example, the user of external device 24 may provide information relating to the patient to server 26, such as demographic information, medical history, lifestyle information, bladder events, level satisfaction with therapy or sensor data.

[0041] Patient 14 may, for example, use a keypad or touch screen of external device 24 to request IMD 16 to deliver or terminate the electrical stimulation, such as when patient 14 senses that a leaking episode may be imminent or when an upcoming void may benefit from terminating therapy that promotes urine retention. In this way, patient 14 may use external device 24 to provide a therapy request to control the delivery of the electrical stimulation “on demand,” e.g., when patient 14 deems the second stimulation therapy desirable. This request may be a therapy trigger event used to terminate electrical stimulation. Patient 14 may also use external device 24 to provide other information to IMD 16, such as information indicative of a phase of a physiological cycle, such as the occurrence of a voiding event.

[0042] IMD 16 and external device 24 may communicate via wireless communication using any techniques known in the art. Examples of communication techniques may include, for example, low frequency or radiofrequency (RF) telemetry, but other techniques are also contemplated. In some examples, external device 24 may include a programming lead that may be placed proximate to the patient’s body near the IMD 16 implant site in order to improve the quality or security of communication between IMD 16 and external device 24.

[0043] IMD 16 also may include a sensor 210 (FIG. 2) for detecting changes in the contraction of bladder 12 and / or evoked activity in response to stimulation. Sensor 210 may include, for example, a pressure sensor for detecting changes in bladder pressure, electrodes for sensing pudendal or sacral afferent nerve signals, electrodes for sensing urinary sphincter EMG signals (or anal sphincter EMG signals in examples in which system 10 provides therapy to manage fecal urgency or fecal incontinence), or any combination thereof. In examples in which sensor 210 is a pressure sensor, the pressure sensor may be a remote sensor that wirelesslyDocket No.: A0012443W001 / 1123-844W001 transmits signals to IMD 16 or may be carried on lead 28 or an additional lead coupled to IMD 16. In some examples, IMD 16 may determine whether a contraction frequency of bladder 12 has occurred based on a pressure signal generated by sensor 210.

[0044] In examples in which sensor 210 includes one or more electrodes for sensing afferent nerve signals, the sense electrodes may be carried on lead 28 or an additional lead coupled to IMD 16. In examples in which sensor 210 includes one or more sense electrodes for generating a urinary sphincter EMG, the sense electrodes may be carried on lead 28 or additional leads coupled to IMD 16. In any case, in some examples, IMD 16 may control the timing of the delivery of the electrical stimulation based on input received from sensor 210.

[0045] Sensor 210 may comprise a patient motion sensor that generates a signal indicative of patient activity level or posture state. In some examples, IMD 16 may terminate the delivery of the electrical stimulation to patient 14 upon detecting a patient activity level exceeding a particular threshold based on the signal from the motion sensor. In other examples, IMD 16 may use sensor 210 to identify posture states known to require the desired therapeutic effect. For example, patient 14 may be more prone to an involuntary voiding event when patient 14 is in an upright posture state compared to when patient 14 is in a supine posture state. In any event, sensor 210 may be configured to detect voiding events and / or the magnitude of a fill level of bladder 12 during the fill cycle.

[0046] System 10 may include memory configured to store first information relating to a patient, wherein the first information is captured during a baseline period that is prior to the patient receiving stimulation, and processor circuitry coupled to the memory, the processor circuitry being configured to receive the first information relating to the patient, receive second information relating to the patient, wherein the second information is captured during an initial therapy assignment and the second information comprises testing data generated by delivering stimulation during an implant procedure, determine initial stimulation program settings based on the first information, the second information and population-informed information, the population-informed information being related to other patients, and cause, during a training period, delivery of therapy based on the initial stimulation program settings.

[0047] FIG. 2 is a block diagram illustrating an example configuration of IMD 16 of FIG. 1 according to an example of the techniques of the disclosure. As shown in FIG. 2, IMD 16 includes sensor 210, processing circuitry 202, therapy delivery circuitry 212, sensing circuitry 211, memory 216, communication circuitry 214, and power source 222. In other examples, IMD 16 may include a greater or fewer number of components. For example, in some examples, such as examples in which IMD 16 deliver the electrical stimulation in an open-loop manner, IMD 16 may not include sensor 210 (e.g., a pressure sensor or electrical signal sensors) and / or impedanceDocket No.: A0012443W001 / 1123-844W001 circuitry 204. In some examples, physiological markers may be provided via patient input on an external device if no sensors (e.g., sensor 210) are included with IMD 16.

[0048] According to some examples, processing circuitry 202 identifies changes to the patient’s physiological state that are relevant to desired changes in neurostimulation. For example, voiding of the bladder may indicate that stimulation is not required for a certain time or until sensor input indicates otherwise. The system may include one or more sensors that sense biomarkers indicative of a change in the relevant physiological state(s), e.g., sensor 210 and / or sensors external to IMD 16. For example, a pressure sensor may detect the amount of bladder pressure. Thus, processing circuitry 202 may be configured to classify certain changes in bladder pressure as corresponding to a void (e.g., when the sensed signals match one or more sets of parameters). Processing circuitry 202 may also classify the relative fullness of the bladder from subsequently detected pressure levels. In some examples, processing circuitry 202 may change the advertising rate in response to a change in physiological state in anticipation of a user attempting to communicate with IMD 16, for example.

[0049] Specified parameters of the bladder pressure signal may be used to inform processing circuitry 202 to identify when voiding events have occurred. For instance, and without limitation, processing circuitry 202 may monitor one or more of bladder pressure, the amount of change in bladder pressure, the duration of change in bladder pressure, and the rate of change in bladder pressure. This data may serve to identify a voiding event. It should be noted that other nerve targets may alter urinary function in a manner that is similar to sacral nerves, such as the tibial nerve, saphenous nerve, pudendal nerve, dorsal nerve of the penis, and the dorsal nerve of the clitoris.

[0050] Sensing circuitry 211 may be configured to sense, via one or more electrodes 29, a signal generated by one or more of nerves or one or more muscles in response to the electrical stimulation. The same or different electrodes may be used to generate stimulation and detect the response signal. In some examples, different sets of electrodes may be used to deliver stimulation and sense a physiological response to the delivered stimulation. Sensing circuitry 211 may receive respective sensed signals from one or more electrodes, such as one or more of electrodes 29, evoked from the electrical stimulation delivered according to the electrical stimulation parameter set. One or more switches, multiplexers, or other hardware may be configured to connect, or disconnect, sensing circuitry 211 and therapy delivery circuitry 212 from any of electrodes 229.

[0051] In some examples, sensing circuitry 211 may perform signal processing of each received signal to remove noise or other unwanted frequencies or artifacts (e.g. stimulation, motion, cardiac etc.). Sensing circuitry 211 may also convert the analog signal to a digital signalDocket No.: A0012443W001 / 1123-844W001 and / or provide other signal processing functionality. Processing circuitry 202 may operate in conjunction with sensing circuitry 211 to evaluate or analyze the received signal for one or more characteristics, such as one or more signal peaks, peak amplitudes, number of peaks, areas under peaks, peak widths, time between peaks, ratios of peak amplitudes, widths, and / or areas, peak latency, signal valleys, valley amplitudes, number of valleys, areas above valleys, valley widths, time between valleys, ratios of valley amplitudes, widths, and / or areas, valley latency, rootmean-square signal value, signal skew, kurtosis, frequency and / or spectral content of the signal(s), or any other suitable signal feature. Using one or more of these characteristics of the sensed signal, processing circuitry 202 may determine whether or not the respective parameter set defined effective stimulation or if a different parameter set may be more effective. Once processing circuity 202 determines that a parameter set defined stimulation that evoked a desired response from the patient, processing circuity 202 may update the parameters that define the pairs of pulses that are defined by the parameter set. In some examples, processing circuity 202 may adjust one or more parameters to use the new parameter value identified as being more effective instead of a previous parameter value.

[0052] In general, IMD 16 may comprise any suitable arrangement of hardware, alone or in combination with software and / or firmware, to perform the techniques attributed to IMD 16 and processing circuitry 202, therapy delivery circuitry 212, sensing circuitry 211, and communication circuitry 214 of IMD 16. In various examples, IMD 16 may include one or more processors, such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components. IMD 16 also, in various examples, may include a memory 216, such as random access memory (RAM), read only memory (ROM), programmable read only memory (PROM), erasable programmable read only memory (EPROM), electronically erasable programmable read only memory (EEPROM), flash memory, comprising executable instructions for causing the one or more processors to perform the actions attributed to them. Moreover, although processing circuitry 202, therapy delivery circuitry 212, and communication circuitry 214 are described as separate circuitry, in some examples, processing circuitry 202, therapy delivery circuitry 212, sensing circuitry 211, and communication circuitry 214 are functionally integrated. In some examples, processing circuitry 202, therapy delivery circuitry 212, sensing circuitry 211, and communication circuitry 214 correspond to individual hardware units, such as microprocessors, ASICs, DSPs, FPGAs, or other hardware units. In further examples, any of processing circuitry 202, therapy delivery circuitry 212, sensing circuitry 211, and communication circuitry 214 mayDocket No.: A0012443W001 / 1123-844W001 correspond to multiple individual hardware units such as microprocessors, ASICs, DSPs, FPGAs, or other hardware units.

[0053] Memory 216 may store any information or instructions that processing circuitry 202 uses to control communication circuitry 214 to transmit advertisements at one or more advertising rates or any other communication as described herein. Memory 216 stores therapy programs 218 that specify stimulation parameter values for the electrical stimulation provided by IMD 16. In some examples, during a communication session, e.g., aBLE communication session, established between external device 24 and IMD 16 during a period of time before implantation of IMD 16 within patient 14, processing circuitry 202 may determine a portion of the stimulation parameter values based on patient specific configuration instructions. The portion of the stimulation parameter values may correspond to stimulation parameters that can be determined independent of sensed patient signals. The patient specific configuration instructions may correspond to user input, e.g., clinician input. Processing circuitry 202 may configure therapy programs 218 based on the instructions. As an example, processing circuitry 202 may determine a pulse width for one or more therapy programs 218. Therapy programs 218 may also store information related to determining and using physiological markers, information relating to physiological cycles and / or dysfunctional states, or any other information. In some examples, IMD 16 may deliver stimulation therapy based on one or more physiological markers. In other examples, IMD 16 may deliver stimulation therapy that is not based on one or more physiological markers.

[0054] In some examples, memory 216 additionally or alternatively stores therapy schedules 220, which processing circuitry 202 may use for controlling the timing of the delivery of the electrical stimulation. In some examples, during the communication session, processing circuitry 202 determines therapy schedules 220 based on the patient specific configuration instructions.

[0055] Information related to sensed bladder contractions and / or posture of patient 14 may be recorded for long-term storage and retrieval by a user, to be used by processing circuitry 202 for adjustment of stimulation parameters (e.g., amplitude, pulse width, pulse rate, duty cycle, etc.) or for use as a physiological marker, or to be sent to server 24. In some examples, memory 216 includes separate memories for storing instructions, electrical signal information, therapy programs 218, and therapy schedules 220.

[0056] Generally, therapy delivery circuitry 212 generates and delivers electrical stimulation under the control of processing circuitry 202. In some examples, processing circuitry 202 controls therapy delivery circuitry 212 by accessing memory 216 to selectively access and load at least one of therapy programs 218 to therapy delivery circuitry 212. For example, in operation, processing circuitry 202 may access memory 216 to load one of therapy programs 218 to therapyDocket No.: A0012443W001 / 1123-844W001 delivery circuitry 212. In other examples, therapy delivery circuitry 212 may access memory 216 and load one of the therapy programs 218.

[0057] By way of example, processing circuitry 202 may access memory 216 to load one of therapy programs 218 to therapy delivery circuitry 212 for delivering the electrical stimulation to patient 14. A clinician or patient 14 may select a particular one of therapy programs 218 from a list using a programming device, such as external device 24, which may be a patient or clinician programmer. Processing circuitry 202 may receive the selection via communication circuitry 214. Therapy delivery circuitry 212 delivers the electrical stimulation to patient 14 according to the selected program for an extended period of time, such as minutes, hours, days, weeks, or until patient 14 or a clinician manually stops or changes the program.

[0058] Therapy delivery circuitry 212 delivers electrical stimulation according to stimulation parameters. In some examples, therapy delivery circuitry 212 delivers electrical stimulation in the form of electrical pulses. In such examples, relevant stimulation parameters may include a voltage amplitude, a current amplitude, a pulse rate, a pulse width, a duty cycle, a duty cycle of the stimulation ON / OFF periods, or the combination of electrodes 29 that therapy delivery circuitry 212 uses to deliver the stimulation signal. In other examples, therapy delivery circuitry 212 delivers electrical stimulation in the form of continuous waveforms. In such examples, relevant stimulation parameters may include a voltage or current amplitude, a frequency, a shape of the stimulation signal, a duty cycle of the stimulation signal, or the combination of electrodes 29 therapy delivery circuitry 212 uses to deliver the stimulation signal.

[0059] In some examples, the stimulation parameters for the stimulation programs 218 may be selected to relax bladder 12, e.g., to reduce a frequency of contractions of bladder 12, after termination of the electrical stimulation. An example range of stimulation parameters for the electrical stimulation that are likely to be effective in treating bladder dysfunction, e.g., upon application to the spinal, sacral, pudendal, tibial, saphenous, dorsal genital, inferior rectal, or perineal nerves, are as follows:1. Frequency or pulse rate: between about 0.5 Hz and about 500 Hz, such as between about 1 Hz and about 250 Hz, between about 1 Hz and about 20 Hz, or about 10 Hz.2. Amplitude: between about 0.1 volts and about 50 volts, such as between about 0.5 volts and about 20 volts, or between about 1 volt and about 10 volts. Alternatively, the amplitude may be between about 0.1 milliamps (mA) and about 50 mA, such as between about 0.5 mA and about 20 mA, or between about 1 mA and about 10 mA.3. Pulse Width: between about 10 microseconds (ps) and about 5000 ps, such as between about 100 ps and about 1000 ps, or between about 100 ps and about 200 ps.Docket No.: A0012443W001 / 1123-844W001

[0060] In some examples, processing circuitry 202 may monitor signals received from sensor 210 to detect contraction of bladder 12 and determine the baseline contraction frequency. In some examples, sensor 210 may be a pressure sensor for detecting changes in pressure of bladder 12, which processing circuitry 202 may correlate to contractions of bladder 12. Processing circuitry 202 may determine a pressure value based on signals received from sensor 210 and compare the determined pressure value to a threshold value to determine whether the signal is indicative of a contraction of bladder 12. In some implementations, processing circuitry 202 monitors pressure of bladder 12 to detect contractions of bladder 12 for a predetermined duration of time and determines a contraction frequency of bladder 12 by calculating a number of contractions of bladder 12 in the predetermined time period.

[0061] In the example of FIG. 2, therapy delivery circuitry 212 drives electrodes on a single lead 28. Specifically, therapy delivery circuitry 212 delivers electrical stimulation to tissue of patient 14 via selected electrodes 29A-29D carried by lead 28. A proximal end of lead 28 extends from the housing of IMD 16 and a distal end of lead 28 extends to a target therapy site, such as a spinal nerve (e.g., an S3 nerve), or a therapy site within the pelvic floor, such as tissue sites proximate a sacral nerve, a pudendal nerve, a tibial nerve, a saphenous nerve, a dorsal genital nerve, an inferior rectal nerve, a perineal nerve, a hypogastric nerve, a urinary sphincter, or any combination thereof. In other examples, therapy delivery circuitry 212 may deliver electrical stimulation with electrodes on more than one lead and each of the leads may carry one or more electrodes. The leads may be configured as an axial lead with ring electrodes or segmented electrodes and / or paddle leads with electrode pads arranged in a two-dimensional array. The electrodes may operate in a bipolar or multi-polar configuration with other electrodes, or may operate in a unipolar configuration referenced to an electrode carried by the device housing or “can” of IMD 16.

[0062] In examples in which sensor 210 includes a motion sensor, processing circuitry 202 may determine a patient activity level or posture state based on a signal generated by sensor 210. This patient activity level may be, for example, sleeping, sitting, exercising, working, running, walking, or any other activity of patient 14. For example, processing circuitry 202 may determine a patient activity level by sampling the signal from sensor 210 and determining a number of activity counts during a sample period, where each activity level of a plurality of activity levels is associated with respective activity counts. In one example, processing circuitry 202 compares the signal generated by sensor 210 to one or more amplitude thresholds stored within memory 216 and identifies each threshold crossing as an activity count. The physical activity may be indicative of a fill level, a voiding event, or any other physiological marker related to the bladder fill cycle.Docket No.: A0012443W001 / 1123-844W001

[0063] In some examples, processing circuitry 202 may configure IMD 16 based on instructions. Communication circuitry 214 may receive the instructions for configuring IMD 16. Communication circuitry 214 includes any suitable hardware, firmware, software or any combination thereof for communicating with another device, such as external device 24 (FIG. 1). Under the control of processing circuitry 202, a telemetry circuit of communication circuitry 214 may receive a wakeup signal from external device 24. In some examples, communication circuitry 214 includes one or more antennas 224. One or more antennas 224 may be configured for one or more of radio frequency (RF) communication, e.g., BLE communication, or inductive communication. Communication circuitry 214 may receive downlink telemetry, e.g., patient input, from and send uplink telemetry, e.g., an alert, to external device 24 with the aid of one or more antennas 224, which may be internal and / or external. In one example, antennas 224 may include an inductive antenna configured to receive and / or transmit information (e.g., a wakeup signal) via inductive energy. Antennas 224 may also include one or more RF antennas configured to operate within a certain frequency band to communicate via a different protocol, such as BLE. In this manner, communication circuitry 214 may be configured to perform two or more different communication protocols (which may use different frequencies or modalities of energy). In other examples, each communication protocol may have completely separate circuits.

[0064] Power source 222 delivers operating power to the components of IMD 16. Power source 222 may include a battery and a power generation circuit to produce the operating power. A battery switch of power source 222 may be open during storage and transit of IMD 16. For example, the battery switch may be open before implantation of IMD 16, such as when IMD 16 is in storage at a clinic. In some examples, the telemetry circuit of communication circuitry 214 may receive an inductive, proximal wakeup signal with the aid of one or more antennas 224. The wakeup signal may transcutaneously power IMD 16. Upon receiving the wakeup signal, processing circuitry 202 may close the battery switch of power source 222, which may enable full operation power from power source 222 of IMD 16. Processing circuitry 202 may control communication circuitry 214 to broadcast advertisements at a first advertising rate, e.g., between 0.5 Hz and 10 Hz for a period of time, e.g., 24 hours. The first advertising rate may be greater than a second advertising rate associated with baseline operation of IMD 16 and may be less than a third advertising rate associated with an interrogation operation of IMD 16. During normal device operation, IMD 16 may advertise at the third advertising rate upon receiving an interrogation or “sting” from external device 24. The “sting” may be similar to a wakeup signal, but it may be delivered using a different method, such as by using inductive communication. If communication circuitry 214 establishes a communication session, e.g., a BLE communicationDocket No.: A0012443W001 / 1123-844W001 session, with external device 24, processing circuitry 202 restarts the period of time. If communication circuitry 214 does not establish the communication session within the period of time, processing circuitry 202 determines to open the battery switch. In some examples, during normal device operation, IMD 16 may switch to a low power mode. IMD 16 may receive a wakeup from external device 24 and begin advertising at the first advertising rate.

[0065] Generally, processing circuitry 202 may control communication circuitry 214 to exchange information with external device 24 or another device external to IMD 16, such as server 26. Processing circuitry 202 may transmit operational information, therapy programs 218, and / or therapy schedules 220 and receive stimulation programs or stimulation parameter adjustments via communication circuitry 214. Also, in some examples, IMD 16 may communicate with other implanted devices, such as stimulators, control devices, or sensors, via communication circuitry 214.

[0066] FIG. 3 is a block diagram illustrating an example configuration of external device 24 of FIG. 1 according to an example of the techniques of the disclosure. While external device 24 may generally be described as a hand-held computing device, external device 24 may be a notebook computer, a smart phone, a workstation, a key fob, or a wearable device, for example. As illustrated in FIG. 3, external device 24 may include a processing circuitry 302, memory 304, user interface 310, telemetry circuitry 306, and power source 308. Memory 304 may store program instructions that, when executed by processing circuitry 302, cause processing circuitry 302 and external device 24 to provide the functionality ascribed to external device 24 throughout this disclosure.

[0067] In general, external device 24 comprises any suitable arrangement of hardware, alone or in combination with software and / or firmware, to perform the techniques attributed to external device 24, and processing circuitry 302, user interface 310, and telemetry circuitry 306 of external device 24. In various examples, external device 24 may include one or more processors, such as one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components. External device 24 also, in various examples, may include a memory 304, such as RAM, ROM, PROM, EPROM, EEPROM, flash memory, a hard disk, a CD-ROM, comprising executable instructions for causing the one or more processors to perform the actions attributed to them. Moreover, although processing circuitry 302 and telemetry circuitry 306 are described as separate circuitry, in some examples, processing circuitry 302, and telemetry circuitry 306 are functionally integrated. In this disclosure, “communication circuitry” and “telemetry circuitry” may be used interchangeably. In some examples, processing circuitry 302 and telemetry circuitry 306 and communication circuitry 214 correspond to individual hardware units, such as microprocessors,Docket No.: A0012443W001 / 1123-844W001 ASICs, DSPs, FPGAs, or other hardware units. In other examples, any of processing circuitry 302, telemetry circuitry 306, communication circuitry 214 may correspond to multiple individual hardware units, such as microprocessors, ASICs, DSPs, FPGAs, or other hardware units.

[0068] Memory 304 may store program instructions that, when executed by processing circuitry 302, cause processing circuitry 302 and external device 24 to provide the functionality ascribed to external device 24 throughout this disclosure. In some examples, memory 304 may further include program information, e.g., stimulation programs defining the neurostimulation, similar to those stored in memory 216 of IMD 16. The stimulation programs stored in memory 304 may be downloaded into memory 216 of IMD 16.

[0069] In certain examples, external device 24 includes a user interface 310 that allows the user, e.g., patient 14 and / or the clinician, to provide input, e.g., instructions for configuring IMD 16. The clinician or patient 14 may provide information relating to patient 14 to external device 24 through user interface 310. For example, during a pre-implantation period and / or during a baseline period after implantation, the clinician may input instructions for configuring IMD 16, such as instructions for configuring one or more stimulation parameter values, demographic information, medical history, and / or baseline symptom data.

[0070] In some examples, patient 14 can request a change in stimulation program or settings through user interface 310. IMD 16 may respond to patient-supplied data from the user interface providing the patient-supplied data to server 26 or by altering therapy. In some examples, patient 14 may use external device 24 (e.g., a handheld device) to record (by pushing a button) a physiological event of interest. Processing circuitry 302 of IMD 16 may respond by turning the therapy on or off, or by adjusting the therapy (e.g., the stimulation strength) or by changing the therapy program. Processing circuitry 302 may store the physiological event of interest in memory 304 for later transmission through telemetry circuitry 306 to server 26. With reference to the urological applications discussed herein, patient 14 could push a button on external device 24 (e.g., their smartphone) when the bladder is voided. This button press may cause telemetry circuitry 306 of external device 24 to send a signal to IMD 16 to turn off for a period of time. Alternatively, the patient 14 could push a button when they feel urgency of a voiding event that is about to occur. This would alert IMD 16 to turn ON, increase its therapy level or activate a specific program consistent with a pre-voiding timing scenario. Consistent with various examples of this disclosure, the patient-supplied data regarding physiological events of interest may be used as information relating to a patient by server 26 to determine stimulation program settings for patient 14.

[0071] User interface 310 may include a button or keypad, lights, a speaker for voice commands, a turnable knob, a display, such as a liquid crystal (LCD), light-emitting diodeDocket No.: A0012443W001 / 1123-844W001 (LED), or cathode ray tube (CRT). In some examples the display may be a touch screen. As discussed in this disclosure, processing circuitry 302 may present and receive information relating to electrical stimulation and resulting therapeutic effects via user interface 310. For example, processing circuitry 302 may receive patient input via user interface 310. The input may be, for example, in the form of pressing a button on a keypad or selecting an icon from a touch screen.

[0072] Processing circuitry 302 may also present information to the patient in the form of alerts related to delivery of the electrical stimulation to patient 14 or a caregiver via user interface 310. Although not shown, external device 24 may additionally or alternatively include a data or network interface to another computing device, to facilitate communication with the other device, and presentation of information relating to the electrical stimulation and therapeutic effects after termination of the electrical stimulation via the other device.

[0073] Telemetry circuitry 306 supports wireless communication between IMD 16 and external device 24 and between server 26 and external device 24 under the control of processing circuitry 302. Telemetry circuitry 306 may also be configured to communicate with another computing device via wireless communication techniques, or direct communication through a wired connection. In some examples, telemetry circuitry 306 may be substantially similar to communication circuitry 214 of IMD 16 described above, providing wireless communication via an RF and / or inductive coupling. In some examples, telemetry circuitry 306 may include an antenna 312, which may take on a variety of forms, such as an internal or external antenna. In some examples, antenna 312 includes more than one antenna, or additional antennas from antenna 312 may be provided.

[0074] Examples of local wireless communication techniques that may be employed to facilitate communication between external device 24 and another computing device include RF communication according to the 802.11 or Bluetooth specification sets, e.g., BLE specification sets, infrared communication, e.g., according to the IrDA standard, or other standard or proprietary telemetry protocols. In this manner, other external devices may be capable of communicating with external device 24 without needing to establish a secure wireless connection.

[0075] Power source 308 delivers operating power to the components of external device 24. Power source 308 may include a battery and a power generation circuit to produce the operating power. In some examples, the battery may be rechargeable to allow extended operation.

[0076] FIG. 4 is a conceptual diagram illustrating an example home screen 406 for navigating within a user interface 400 according to an example of the techniques of the disclosure. User interface 400 may be an example of user interface 310 of external device 24.Docket No.: A0012443W001 / 1123-844W001 User interface 400 may include several different screens that the user can navigate to, each of the screens having different functions to view sensed information, view stored data, and / or adjust various stimulation parameters. As shown in the example of FIG. 4, home screen 402 includes recent reports 408, home screen indicator 404, and connect button 406. The user may view recent reports associated with various patients by selecting a report of reports 408. The user may navigate to screens other than home screen 402 by selecting a button of navigation buttons 410 other than home button 404. In some examples, when home button 404 is selected, home button 404 may change color or otherwise indicate to the user that the user is interacting with home screen 402.

[0077] The user can select connect button 406 to initiate a connection with an IMD, such as IMD 16. In some examples, after receiving a wakeup signal, e.g., after receiving a wakeup signal from external device 24 or another external device, processing circuitry 202 of IMD 16 begins advertising at a first rate for a period of time. The user may control external device 24 to establish a communication session with IMD 16 during the period of time by selecting connect button 406 and connecting to IMD 16. As will be discussed with respect to FIG. 5, in some examples, user interface 400 generates a pop-up screen that allows the user to select an IMD, e.g., IMD 16, and establish a communication session.

[0078] FIG. 5 is a conceptual diagram illustrating an example pop-up screen 502 for selecting an IMD for setup according to an example of the techniques of the disclosure. A user may, upon selecting connect button 406 of home screen 402, view pop-up screen 502. Pop-up screen 502 includes a refresh list button 504, a cancel button 506, and a list of available devices 510. In the example of FIG. 5, list of available devices 510 includes serial numbers for each device of list of available devices 510. If the user determines the serial number of the device the user wishes to connect to, e.g., IMD 16, is included in list of available devices 510, the user may select the device by clicking on the available device, e.g., by clicking on device box 508. If the user determines the serial number of the device the user wishes to connect to is not included in list of available devices 510, the user may select refresh list button 504. If the user decides to return to home screen 402 without connecting to a device, the user may select cancel button 506.

[0079] FIG. 6 is a conceptual diagram illustrating an example screen 600 of user interface 400 for setting up one or more user specific configurations of an IMD according to an example of the techniques of the disclosure. Upon establishing a communication session with an IMD, e.g., IMD 16, the user may navigate to example screen 600. Example screen 600 includes a device identification box 616. In the example of FIG. 6, device identification box 616 includes the serial number of IMD 16. While the communication session is established and, in some examples, before implantation of IMD 16, e.g., minutes, hours, or days before implantation, the user mayDocket No.: A0012443W001 / 1123-844W001 input instructions for pre-configuring IMD 16. In some examples, the instructions may include patient specific configuration instructions for configuring one or more therapy program parameter values and / or a therapy schedule of the patient. To provide the instructions, the user may select one or more setup tabs 602. Setup tabs 602 may include a plurality of tabs, such as tabs 606, 608, 610, 612, and 614. In some examples, setup tabs 602 may include one or more tabs that the user cannot access until the user starts a service life of IMD 16, such as tab 606. In some examples, starting a service life of IMD 16 may comprise activating IMD 16. In the example of FIG. 6, tab 606 is grayed out to indicate to the user that the user cannot access tab 606. Similarly, the user may not be able to take impedance measurements until starting the service life of IMD 16. Notification box 618 provides an indication to the user that impedance cannot be measured until the service life of IMD 16 is started. The user may start the service life of IMD 16 by selecting start service life box 604. In some examples, the user may wait to start the service life of IMD 16 until implantation of IMD 16 or in the operating room just before implantation of IMD 16.

[0080] Some tabs included in configuration actions 602 may be optional for the user to interact with, such as tabs 608 and 610. The user may be required to provide input corresponding to other tabs, such as tabs 606, 612, and 614. In the example of FIG. 6, the user may be able to select tabs 612 and 614 before starting the service life of IMD 16 and during the period of time while a communication session is established between IMD 16 and external device 24. Upon selecting either of tabs 612 or 614, a pop-up window may appear, or user interface 400 may generate a different screen corresponding to the selected tab. When the user selects tab 614, user interface 400 may prompt the user to provide instructions indicative of a therapy schedule, also referred to as a therapy cadence. When the user selects tab 612, user interface 400 may prompt the user to provide instructions indicative of one or more therapy parameter values. As will be discussed with respect to FIG. 7, In some examples, the therapy parameter values that the user can provide instructions for before starting the service life of IMD 16 may be limited.

[0081] The user may end the communication session between IMD 16 and external device 24 by selecting disconnect button 603. In some examples, memory 304 of external device 24 and / or memory 216 of IMD 16 may store the instructions. In some examples, if the period of time elapses without a communication session being established with IMD 16 and external device 24, processing circuitry 202 of IMD 16 may determine to erase the instructions. Processing circuitry 202 may determine to open a battery switch of power source 222.

[0082] FIG. 7 is a conceptual diagram illustrating an example screen 700 of user interface 400 for setting one or more therapy program parameters according to an example of the techniques of the disclosure. User interface 400 may present example screen 700 in response toDocket No.: A0012443W001 / 1123-844W001 the user selecting tab 612 of example screen 600. Example screen 700 may include programs 710. Programs 710 may each be associated with different electrode combinations and other stimulation parameter values. Example screen 700 may display pop-up window 712, which may include parameter value list 708 including electrode combinations, amplitude limits, e.g., voltage and / or current amplitude limits, pulse widths, rates, and lead test results. In some examples, example screen 700 displays pop-up window 712 in response to the user selecting dropdown box 704. In the example of FIG. 7, the electrode combination is on display in display box 702. The display of display box 702 may change when the user selects a different parameter value from parameter value list 708. The user may provide instructions for configuring each therapy program of programs 710. In some examples, the user may input instructions for configuring electrode combinations and pulse widths for each therapy program before starting the service life of IMD 16. The user may not be able to input instructions for configuring amplitude limits, rates, or lead test results for each therapy program until starting the service life of IMD 16. In some examples, the user may not be able to input instructions for configuring stimulation parameter values that require sensed patient data, e.g., impedance data, as input until starting the service life of IMD 16 and implanting IMD 16. Example screen 700 may include a notification 706 reminding the user that the service life must be started before the user can provide user input corresponding to amplitude limits.

[0083] FIG. 8 is a conceptual diagram illustrating an example pop-up window 802 of example screen 600 for starting a service life of an IMD according to an example of the techniques of the disclosure. Upon inputting instructions for configuring electrode combinations and pulse widths for programs 710 of example screen 700, the user may return to example screen 600. The user may select start service life box 604. User interface 400 may generate pop-up screen 802 in response to the user selecting start service life box 604. Starting the service life of IMD 16 may be irreversible. In some examples, after starting the service life, IMD 16 is no longer capable of reverting back to a shelf state. Pop-up screen 802 may prompt the user to read information regarding starting the service life. Pop-up screen 802 includes an acknowledgement toggle 804. The user can slide acknowledgement toggle 804 to indicate the user has read and acknowledged the information. Once the user slides acknowledgement toggle 804 to indicate the user has read and acknowledged the information, the user may select activate implant button 806, which activates the service life of IMD 16. The user may, at any time after selecting start service life button 604 and before selecting activate implant button 806, select cancel button 808 to cancel starting the service life of IMD 16. After starting the service life of IMD 16 and implanting IMD 16, the user may finish configuring IMD 16 by inputting instructions for configuring the stimulation parameter values that require sensed patient data, such as amplitudeDocket No.: A0012443W001 / 1123-844W001 limits, rates, and lead test results. The user may also control IMD 16 to measure impedance values for patient 14.

[0084] FIG. 9 is a flowchart illustrating an example operation for dynamically adjusting an advertising rate of an IMD according to an example of the techniques of the disclosure. The process of FIG. 9 is described with respect to components and circuitry of IMD 16, but other medical devices may function similarly.

[0085] As shown in the example of FIG. 9, communication circuitry of an IMD, e.g., communication circuitry 214 of IMD 16, receives a wakeup signal (902). In some examples, a telemetry circuit of communication circuitry 214 receives the wakeup signal with an antenna of one or more antennas 224. The wakeup signal may be received via inductive coupling which can energize the inductive coupling circuitry when IMD 16 is in the low power state. In some examples, processing circuitry 202 determines IMD 16 received the wakeup signal. IMD 16 can receive the wakeup signal from external device 24. External device 24 may in some examples be a clinician and / or patient programmer. In other examples, external device 24 may be a handheld computer, such as a patient smartphone or a clinician tablet. Before receiving the wakeup signal, a battery switch associated with power source 222 of IMD 16 may be in an open configuration which prevents current from flowing from power source 222 to some or all of the circuitry of IMD 16. Upon receiving the wakeup signal, processing circuitry 202 may control IMD 16 to close the battery switch, enabling full functionality of power source 222.

[0086] Processing circuitry 202 then controls communication circuitry 214 to broadcast advertisements at a first advertising rate for a period of time, such as for 24 hours (904). In some examples, the period of time may range from 4 hours to 48 hours, 8 to 48 hours, or 12 to 24 hours, but the period of time may be also longer or shorter. In general, the period of time may be established to enable initial programming of IMD 16 before implantation, while also returning to the low power state should the implantation not occur as scheduled. The first advertising rate may be between 0.5 Hz and 10 Hz in some examples. The first advertising rate may be between an advertising rate associated with baseline operation of IMD 16 and an advertising rate associated with an interrogation operation of IMD 16. IMD 16, after implantation, may operate at a baseline operation and advertise at a second advertising rate of less than 0.5 Hz until IMD 16 receives an interrogation signal, or a “sting.” This second advertising rate may conserve power during regular operation. When IMD 16 receives a sting, e.g., when IMD 16 receives a proximal, inductive signal from an external device, such as external device 24, processing circuitry 202 of IMD 16 may control communication circuitry 214 to advertise at a third advertising rate, e.g., between 10 Hz and 50 Hz, associated with the interrogation operation for a predetermined period of time, e.g., 60 seconds, before returning to the advertising at the second advertising rate. InDocket No.: A0012443W001 / 1123-844W001 some examples, processing circuitry 202 of IMD 16 may control communication circuitry 214 to advertise at the third advertising rate based on a sensed physiological signal.

[0087] Processing circuitry 202 determines whether IMD 16 established a communication session with another device, e.g., external device 24, within the period of time (906). This communication session may be the initial provision of IMD 16 with user-specific information prior to implantation. This initial provision may include user-specific information, such as general user information, condition, age, etc., but may not include therapy parameters that still need to be programmed by a clinician. In some examples, if IMD 16 established the communication session within the period of time (“YES” branch of block 906), processing circuitry 202 determines to restart the period of time (908). As an example, if the period of time is 8 hours, and before the 8 hour period has elapsed, processing circuitry 202 determines IMD 16 established the communication session, processing circuitry 202 restarts the 8 hour period and continues to control communication circuitry 214 to advertise at the first advertising rate for the restarted period of time, or another 8 hour period. In some examples, the restarted period of time overlaps with the previous period of time. For example, if processing circuitry 202 determines IMD 16 established the communication session after 4 hours, processing circuitry 202 may restart the period of time and continue advertising at the second advertising rate for another 8 hour period starting at the 4 hour point of the previous period of time. In this example, processing circuitry 202 controls communication circuitry 214 to advertise at the first advertising rate for a total of 12 hours. In some examples, processing circuitry 202 may receive instructions for patient specific configuration of IMD 16 after establishing the communication session in the period of time. As an example, processing circuitry 202 may receive instructions from a user, e.g., a clinician, indicative of one or more stimulation therapy parameter values, e.g., a pulse width and / or an electrode combination for one or more therapy programs, or a therapy schedule for patient 14. In some examples, IMD 16 may proceed to a different advertising rate after receiving parameter values such as stimulation therapy parameter values which indicate IMD 16 is implanted and ready for normal operation. In some examples, before determining to restart the period of time, processing circuitry 202 determines whether a total amount of time that IMD 16 has been advertising at the first advertising rate exceeds a threshold. If processing circuitry 202 determines the total amount of time exceeds a threshold, processing circuitry 202 may determine not to restart the period of time. In some examples, by limiting the total amount of advertising time, processing circuitry 202 may prevent battery drain.

[0088] If IMD 16 did not establish the communication session within the period of time (“NO” branch of block 906), processing circuitry 202 determines to change the first advertising rate (910). As an example, processing circuitry 202 may determine to stop advertising. AsDocket No.: A0012443W001 / 1123-844W001 another example, processing circuitry 202 may determine to advertise at a slower rate, such as at 0.1 Hz. In some examples, processing circuitry 202 determines to open the battery switch of power source 222, which would stop advertising due to shutting off power. If processing circuitry 202 received instructions for configuring the IMD, processing circuitry 202 may determine to erase the instructions upon determining IMD 16 did not establish the communication session with external device 24. If processing circuitry 202 opens the battery switch or otherwise returns IMD 16 to the low power state, IMD 16 can again receive the wakeup signal at another time (902). Prior to returning to the low power state, processing circuitry 202 may erase or delete any user-specific information that was stored to memory so that IMD 16 can be used with a different patient at a later time.

[0089] FIG. 10 is a flowchart illustrating an example operation for dynamically adjusting an advertising rate of IMD 16 at various times before and after starting a service life of IMD 16 according to an example of the techniques of the disclosure. As shown in the example of FIG. 10, pre-operatively, communication circuitry 214 of IMD 16 receives a wakeup signal (1002). The wakeup signal may be a proximal, inductive signal from an external device, e.g., external device 24. The inductive signal may temporarily transcutaneously power IMD 16. Upon receiving the wakeup signal, processing circuitry 202 may determine to close a battery switch of power supply 222, enabling full function of power supply 222 (1004). Processing circuitry 202 controls communication circuitry 214 to broadcast advertisements at a first advertising rate, e.g., 0.5 Hz to 10 Hz, for a period of time, e.g., 8 hours to 48 hours (1006). During the period of time, processing circuitry 202 may establish a communication session with an external device, e.g., external device 24, which may be a patient programmer or a clinician programmer. Upon establishing the communication session, processing circuitry 202 may receive instructions for patient specific user configuration for pre-configuring the IMD (1008). In some examples, a user, e.g., the clinician, may input the instructions for pre-configuring the IMD via user interface 310 of external device 24. In other examples, user device 24 determines and sends the instructions independent of the clinician.

[0090] Processing circuitry 202 determines whether the period of time has elapsed and / or patient 14 has backed out of an implantation procedure for IMD 16 (1010). In some examples, processing circuitry 202 determines the period of time has elapsed when the period of time elapses without processing circuitry 202 determining that a communication session was not established with external device 24 within the period of time. In some examples, each time IMD 16 establishes a communication session with external device 24, the period of time restarts. If the period of time has elapsed with a communication session being established and / or the patient has backed out (“YES” branch of block 1010), processing circuitry 202 determines to open theDocket No.: A0012443W001 / 1123-844W001 battery switch of power source 222 and / or revert to a shelf state (1012). In some examples, the shelf state may include keeping the battery switch closed and continuing to advertise as a relatively lower rate. In some examples, the shelf state includes the battery switch being opened and disabling the operational power of power source 222. Processing circuitry 202 erases the instructions for pre-configuring IMD 16. Processing circuitry 202 can receive a subsequent wakeup signal from external device 24 and determine to close the battery switch again, thereby repeating the process as needed. In some examples, instead of letting the period of time elapse, the clinician may provide user input indicating that patient 14 backed out of the procedure to initiate the process of reverting IMD 16 to the shelf state.

[0091] If the period of time has not elapsed and the patient has not backed out (“NO” branch of block 1010), processing circuitry 202 may receive an indication to start a service life of IMD 16 (1014). In some examples, starting the service life may be irreversible. In some examples, the clinician may provide user input via user interface 310 to start the service life. In some examples, the clinician may start the service life of IMD 16 immediately before, during, or immediately after a procedure for implanting IMD 16. In some examples, the clinician starts the service life of IMD 16 in the operating room.

[0092] Upon starting the service life of IMD 16, and, in some examples, post-operatively, the processing circuitry 202 completes setup of IMD 16 (1016). In some examples, the clinician provides input via user interface 310 to complete the setup of IMD 16. Processing circuitry 202 controls communication circuitry 214 to broadcast advertisements at a baseline operation rate, e.g., at a rate of less than 0.5 Hz, such as 0.1 Hz (1018). The baseline operation rate may be a second advertising rate lower than the first advertising rate. Processing circuitry 202 continuously checks for interrogations, or “stings” (1020). The sting may be similar to or different from a wakeup signal. In some examples, the sting may be an indictive communication. In some examples, the user, e.g., patient 14, may interact with external device 24, e.g., a patient programmer, to initiate an interrogation or “sting” by providing user input to cause external device 24 to transmit a signal, e.g., a proximal inductive signal, to IMD 16, causing communication circuitry 214 of IMD 16 to broadcast advertisements at a third advertising rate higher than the first and second advertising rates. In some examples, the third advertising rate may be referred to as an interrogation operation rate. In some examples, the interrogation operation rate is between 10 Hz and 50 Hz, but other ranges are also possible.

[0093] The signal that external device 24 transmits may include priority information indicating one or more devices, e.g., one or more devices belonging to patient 14, a caregiver of patient 14, and / or the clinician, that are to be given priority for establishing communication, which may prevent unwanted connections with non-user devices.Docket No.: A0012443W001 / 1123-844W001

[0094] If processing circuitry 202 determines that IMD 16 has not received an interrogation (“NO” branch of block 1020), processing circuitry 202 determines to continue to control communication circuitry 214 to advertise at the baseline operation rate (1018). Processing circuitry 202 continues to check for interrogations (1020). If processing circuitry 202 determines IMD 16 has received an interrogation (“YES” branch of block 1020), processing circuitry 202 determines to control communication circuitry 214 to advertise at the interrogation operation rate for a second period of time, e.g., 10 seconds to 60 seconds (1022). In this post-operative period, the second period of time for the higher advertising rate may be shorter or longer in other examples. This relatively short period of time for the higher advertising rate may be selected to be sufficient to enable connection to an external device (e.g., a clinician or patient programmer), but short enough that power usage is minimized if communication is not needed. In this manner, the higher advertising rate may be set to be on the order of a few seconds to a few minutes in some examples. At the conclusion of the second period of time, processing circuitry 202 determines to switch back to controlling communication circuitry 214 to advertise at the baseline operation rate (1018). In some examples, processing circuitry 202 may additionally adjust an advertisement rate based on a change in a sensed physiological signal, e.g., a change in a sensed biomarker. For example, based on the change in the sensed physiological signal, processing circuitry 202 may determine to establish a connection with external device 24 to communicate the change in the sensed physiological signal to and / or to instruct a user to adjust therapy based on the sensed physiological signal.

[0095] The following examples are described herein.

[0096] Example 1. An implantable medical device (IMD) comprising: communication circuitry configured for wireless communication according to a radio frequency (RF) communication protocol; and processing circuitry configured to: determine that the IMD received a wakeup signal; responsive to determining that the IMD received the wakeup signal, control the communication circuitry to broadcast advertisements at a first advertising rate for a period of time using the RF communication protocol, the period of time being at least 8 hours; determine that a communication session was not established with an external device within the period of time; and responsive to determining that the communication session was not established with the external device, control the communication circuitry to change the first advertising rate of the advertisements.

[0097] Example 2. The IMD of example 1, wherein the processing circuitry is further configured to: determine that a communication session was established with the external device within the period of time; and responsive to determining that the communication session was established with the external device, restart the period of time.Docket No.: A0012443W001 / 1123-844W001

[0098] Example 3. The IMD of any of examples 1 or 2, wherein the processing circuitry is further configured to: establish the communication session during the period of time in response to receiving the wakeup signal from the external device; and receive patient specific user configuration instructions for configuring the IMD.

[0099] Example 4. The IMD of example 3, wherein the instructions for configuring the IMD include instructions for configuring one or more of: one or more therapy programs of the IMD; or a schedule for therapy.

[0100] Example 5. The IMD of any of examples 1 through 4, wherein the processing circuitry is configured to, responsive to determining that the communication session was not established within the period of time, erase the instructions for configuring the IMD.

[0101] Example 6. The IMD of any of examples 1 through 5, further comprising a battery switch, wherein the processing circuitry is further configured to: close the battery switch in response to receiving the wakeup signal, wherein closing the battery switch enables full operational power from a battery of the IMD.

[0102] Example 7. The IMD of any of examples 1 through 6, wherein the first advertising rate is greater than a second advertising rate and less than a third advertising rate, the second advertising rate being associated with a baseline IMD operation and the third advertisement rate being associated with an interrogation operation of the IMD.

[0103] Example 8. The IMD of any of examples 1 through 7, wherein the first advertising rate is between 0.5 Hertz (Hz) to 10 Hz.

[0104] Example 9. The IMD of any of examples 7 or 8, wherein the second advertising rate is less than 0.5 Hz and the third advertising rate is between 10 Hz and 50 Hz.

[0105] Example 10. The IMD of any of examples 1 through 9, wherein the processing circuitry is configured to change the first advertising rate by stopping the advertisements.

[0106] Example 11. The IMD of any of examples 1 through 10, further comprising a battery switch, wherein the processing circuitry is further configured to: open the battery switch in response to determining that the communication session was not established with the external device within the period of time, wherein opening the battery switch disconnects a battery of the IMD.

[0107] Example 12. The IMD of any of examples 1 through 11, wherein the period of time is between 8 hours and 48 hours.

[0108] Example 13. The IMD of any of examples 1 through 12, wherein the RF communication protocol comprises one or more of: a Bluetooth Low Energy (BLE) protocol; a Bluetooth protocol; a Zigbee protocol; an ANT protocol; or an ANT+ protocol.Docket No.: A0012443W001 / 1123-844W001

[0109] Example 14. The IMD of any of examples 1 through 13, further comprising telemetry circuitry configured to receive the wakeup signal, wherein the wakeup signal comprises an inductive signal received from one of a patient programmer or a clinician programmer.

[0110] Example 15. The IMD of any of examples 1 through 14, wherein the IMD comprises stimulation circuitry configured to generate and deliver electrical stimulation therapy.

[0111] Example 16. A method comprising: determining, by processing circuitry of an implantable medical device (IMD), that the IMD received a wakeup signal; controlling, by the processing circuitry and response to determining that the IMD received the wakeup signal, communication circuitry of the IMD to broadcast advertisements at a first advertising rate for a period of time using a radio frequency (RF) communication protocol, the period of time being at least 8 hours; determining, by the processing circuitry, that a communication session was not established with an external device within the period of time; and controlling, by the processing circuitry and responsive to determining that the communication session was not established with the external device within the period of time, the communication circuitry to change the first advertising rate of the advertisements.

[0112] Example 17. The method of example 16, further comprising: determining, by the processing circuitry, that a communication session was established with the external device within the period of time; and restarting, by the processing circuitry and responsive to determining that the communication session was established with the external device, the period of time.

[0113] Example 18. The method of any of examples 16 or 17, further comprising: establishing, by the processing circuitry, the communication session during the period of time in response to receiving the wakeup signal from the external device; wherein the IMD is configured to: receiving, by the processing circuitry, patient specific user configuration instructions for configuring the IMD.

[0114] Example 19. The method of example 18, wherein the instructions for configuring the IMD include instructions for configuring one or more of: one or more therapy programs of the IMD; or a schedule for therapy.

[0115] Example 20. The method of any of examples 16 through 19, further comprising: erasing, by the processing circuitry and responsive to determining that the communication session was not established within the period of time, the instructions for configuring the IMD.

[0116] Example 21. The method of any of examples 16 through 20, wherein the IMD further comprises a battery switch, the method further comprising: closing, by the processingDocket No.: A0012443W001 / 1123-844W001 circuitry and in response to receiving the wakeup signal, the battery switch, wherein closing the battery switch enables full operational power from a battery of the IMD.

[0117] Example 22. The method of any of examples 16 through 21, wherein the first advertising rate is greater than a second advertising rate and less than a third advertising rate, the second advertising rate being associated with a baseline IMD operation and the third advertisement rate being associated with an interrogation operation of the IMD.

[0118] Example 23. The method of any of examples 16 through 22, wherein the first advertising rate is between 0.5 Hertz (Hz) to 10 Hz.

[0119] Example 24. The method of any of examples 22 or 23, wherein the second advertising rate is less than 0.5 Hz and the third advertising rate is between 10 Hz and 50 Hz.

[0120] Example 25. The method of any of examples 16 through 24, wherein changing the first advertising rate of the advertisements comprises stopping the advertisements.

[0121] Example 26. The method of any of examples 16 through 25, wherein the IMD further comprises a battery switch, the method further comprising: opening, by the processing circuitry and in response to determining that the communication session was not established with the external device within the period of time, the battery switch, wherein opening the battery switch disconnects a battery of the IMD.

[0122] Example 27. The method of any of examples 16 through 26, wherein the period of time is between 8 hours and 48 hours.

[0123] Example 28. The method of any of examples 16 through 27, wherein the RF communication protocol comprises one or more of: a Bluetooth Low Energy (BLE) protocol; a Bluetooth protocol; a Zigbee protocol; an ANT protocol; or an ANT+ protocol.

[0124] Example 29. The method of any of examples 16 through 28, further comprising: receiving, via telemetry circuitry of the IMD, the wakeup signal, wherein the wakeup signal comprises an inductive signal received from one of a patient programmer or a clinician programmer.

[0125] Example 30. The method of any of examples 16 through 29, wherein the IMD comprises stimulation circuitry configured to generate and deliver electrical stimulation therapy.

[0126] Example 31. A non-transitory computer-readable medium storing instructions that when executed cause processing circuitry to: determine that an implantable medical device (IMD) comprising the processing circuitry received a wakeup signal; responsive to determining that the IMD received the wakeup signal, control communication circuitry of the IMD configured for wireless communication according to a radio frequency (RF) protocol to broadcast advertisements at a first advertising rate for a period of time using the RF communication protocol, the period of time being at least 8 hours; determine that a communication session wasDocket No.: A0012443W001 / 1123-844W001 not established with an external device within the period of time; and responsive to determining that the communication session was not established with the external device, control the communication circuitry to change the first advertising rate of the advertisements.

[0127] The techniques of this disclosure may be implemented, at least in part, in hardware, software, firmware or any combination thereof. For example, various aspects of the described techniques may be implemented within one or more processors or processing circuitry, including one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components. The term “processor” or “processing circuitry” may generally refer to any of the foregoing logic circuitry, alone or in combination with other logic circuitry, or any other equivalent circuitry. A control unit including hardware may also perform one or more of the techniques of this disclosure.

[0128] Such hardware, software, and firmware may be implemented within the same device or within separate devices to support the various operations and functions described in this disclosure. In addition, any of the described units, circuits or components may be implemented together or separately as discrete but interoperable logic devices. Depiction of different features as circuits or units is intended to highlight different functional aspects and does not necessarily imply that such circuits or units must be realized by separate hardware or software components. Rather, functionality associated with one or more circuits or units may be performed by separate hardware or software components or integrated within common or separate hardware or software components.

[0129] The techniques described in this disclosure may also be embodied or encoded in a computer-readable medium, such as a computer-readable storage medium, containing instructions that may be described as non-transitory media. Instructions embedded or encoded in a computer-readable storage medium may cause a programmable processor, or other processor, to perform the method, e.g., when the instructions are executed. Computer readable storage media may include random access memory (RAM), read only memory (ROM), programmable read only memory (PROM), erasable programmable read only memory (EPROM), electronically erasable programmable read only memory (EEPROM), flash memory, a hard disk, a CD-ROM, a floppy disk, a cassette, magnetic media, optical media, or other computer readable media.

[0130] Various examples have been described. These and other examples are within the scope of the following claims.

Claims

Docket No.: A0012443W001 / 1123-844W001 WHAT IS CLAIMED IS:

1. An implantable medical device (IMD) comprising:communication circuitry configured for wireless communication according to a radio frequency (RF) communication protocol; andprocessing circuitry configured to:determine that the IMD received a wakeup signal;responsive to determining that the IMD received the wakeup signal, control the communication circuitry to broadcast advertisements at a first advertising rate for a period of time using the RF communication protocol, the period of time being at least 8 hours;determine that a communication session was not established with an external device within the period of time; andresponsive to determining that the communication session was not established with the external device, control the communication circuitry to change the first advertising rate of the advertisements.

2. The IMD of claim 1, wherein the processing circuitry is further configured to:determine that a communication session was established with the external device within the period of time; andresponsive to determining that the communication session was established with the external device, restart the period of time.

3. The IMD of any of claims 1 or 2, wherein the processing circuitry is further configured to:establish the communication session during the period of time in response to receiving the wakeup signal from the external device; andreceive patient specific user configuration instructions for configuring the IMD.

4. The IMD of claim 3, wherein the instructions for configuring the IMD include instructions for configuring one or more of:one or more therapy programs of the IMD; ora schedule for therapy.Docket No.: A0012443W001 / 1123-844W001 5. The IMD of any of claims 1 through 4, wherein the processing circuitry is configured to, responsive to determining that the communication session was not established within the period of time, erase the instructions for configuring the IMD.

6. The IMD of any of claims 1 through 5, further comprising a battery switch, wherein the processing circuitry is further configured to:close the battery switch in response to receiving the wakeup signal, wherein closing the battery switch enables full operational power from a battery of the IMD.

7. The IMD of any of claims 1 through 6, wherein the first advertising rate is greater than a second advertising rate and less than a third advertising rate, the second advertising rate being associated with a baseline IMD operation and the third advertisement rate being associated with an interrogation operation of the IMD.

8. The IMD of any of claims 1 through 7, wherein the first advertising rate is between 0.5 Hertz (Hz) to 10 Hz.

9. The IMD of any of claims 7 or 8, wherein the second advertising rate is less than 0.5 Hz and the third advertising rate is between 10 Hz and 50 Hz.

10. The IMD of any of claims 1 through 9, wherein the processing circuitry is configured to change the first advertising rate by stopping the advertisements.

11. The IMD of any of claims 1 through 10, further comprising a battery switch, wherein the processing circuitry is further configured to:open the battery switch in response to determining that the communication session was not established with the external device within the period of time, wherein opening the battery switch disconnects a battery of the IMD.

12. The IMD of any of claims 1 through 11, wherein the period of time is between 8 hours and 48 hours.

13. The IMD of any of claims 1 through 12, wherein the RF communication protocol comprises one or more of:a Bluetooth Low Energy (BLE) protocol;Docket No.: A0012443W001 / 1123-844W001 a Bluetooth protocol;a Zigbee protocol;an ANT protocol; oran ANT+ protocol.

14. The IMD of any of claims 1 through 13, further comprising telemetry circuitry configured to receive the wakeup signal, wherein the wakeup signal comprises an inductive signal received from one of a patient programmer or a clinician programmer.

15. The IMD of any of claims 1 through 14, wherein the IMD comprises stimulation circuitry configured to generate and deliver electrical stimulation therapy.

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