Adjusting advertising rates in medical devices

Abstract

An example system includes telemetry circuitry configured to manage communications between a medical device and an external device. In one example, an implantable medical device (IMD) includes: telemetry circuitry configured to transmit a communication announcement packet; and a therapy circuit configured for delivering therapy according to the therapy schedule. The IMD may also include processing circuitry configured to: control the telemetry circuitry to transmit a communication announcement packet at a first announcement rate; determining an announcement rate change event based on the treatment schedule; and in response to determining the announcement rate change event, controlling the telemetry circuit to transmit the communication announcement packet at a second announcement rate different from the first announcement rate.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application 63 / 586,820, filed September 29, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates in general to communication solutions for implantable medical devices. Background Technology

[0004] Medical devices can be external or implanted and can be used to sense neural signals (e.g., central and peripheral nerves) and / or deliver electrical stimulation therapy to various tissue sites in a patient to treat a variety of symptoms or conditions, such as, for example, chronic pain, tremor, Parkinson's disease, other movement disorders, epilepsy, urinary or fecal incontinence, sexual dysfunction, obesity, gastroparesis, sleep apnea, neural control of prosthetic devices, or to provide one or more of the following through stimulation: peripheral sensation. One medical device delivers electrical stimulation therapy via one or more leads, which include electrodes located near a target location associated with the patient's brain, spinal cord, pelvic nerves, peripheral nerves, or gastrointestinal tract. For bipolar stimulation, the electrodes for stimulation may be on one or more leads. For monopolar stimulation, the electrodes may include one or more leads, and the electrodes on the stimulator housing are located remotely from the target site (e.g., near the clavicle). Leadless stimulation can be used using electrodes mounted on the stimulator housing. Therefore, electrical stimulation is used for various therapeutic applications, such as deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic floor stimulation, gastric stimulation, or peripheral nerve field stimulation (PNFS).

[0005] Clinicians can select values ​​for multiple programmable parameters via an external programmer to define the electrical stimulation therapy delivered to the patient by the implanted stimulator. For example, clinicians can select one or more electrodes for delivering stimulation, the polarity of each selected electrode, the voltage or current pulse amplitude, pulse width, and pulse rate as stimulation parameters. A set of parameters, such as a set of parameters including electrode combination, electrode polarity, amplitude, pulse width, and pulse frequency, can be called a program because this set of parameters defines the electrical stimulation therapy to be delivered to the patient. Summary of the Invention

[0006] This disclosure describes example techniques for managing communication protocols between a medical device (e.g., an implantable medical device or IMD) and an external device (such as an external programmer). In some communication protocols (such as Bluetooth communication), the IMD may send announcement packets that can be detected by the external device to establish a communication session. The IMD may modulate the announcement rate of those announcement packets to improve communication with the external device while reducing power consumption.

[0007] In one example, the IMD can determine when a notification rate change event occurs that will trigger a change in the notification rate. The notification rate change event can be based on a treatment schedule. For example, the IMD determines that the start of electrical stimulation therapy delivery could be a notification rate change event, and in response to this event, the IMD will increase the notification rate of the notification group. This increase in the notification rate reduces the time required to establish a connection to an external device (such as a programmer) that the user might wish to use to adjust parameters defining the electrical stimulation therapy. Once the treatment for that session is complete, the IMD can identify it as another notification rate change event and accordingly reduce the notification rate to decrease power consumption during periods when the external device is unlikely to interact with the IMD. The IMD can also use other notification rate change events, such as a predetermined time before the start of a treatment session, a time before the end of a treatment session, a time of day, or any situation where the IMD can benefit from increasing or decreasing the communication notification rate.

[0008] In one example, an implantable medical device includes: a telemetry circuit configured to transmit communication notification packets; a stimulation generation circuit configured to deliver electrical stimulation therapy according to a treatment schedule; and a processing circuit configured to: control the telemetry circuit to transmit the communication notification packets at a first notification rate; determine a notification rate change event based on the treatment schedule; and, in response to determining the notification rate change event, control the telemetry circuit to transmit the communication notification packets at a second notification rate different from the first notification rate.

[0009] In another example, a method includes: a stimulation generation circuit controlled by a processing circuit to deliver electrical stimulation therapy according to a treatment schedule; a telemetry circuit controlled by the processing circuit to send communication notification packets at a first notification rate; the processing circuit and the treatment schedule to determine a notification rate change event; and in response to determining the notification rate change event, the processing circuit controlled the telemetry circuit to send the communication notification packets at a second notification rate different from the first notification rate.

[0010] In one example, a non-transitory computer-readable storage medium includes instructions that, when executed by processing circuitry, cause the processing circuitry to: control a stimulation generation circuitry to deliver electrical stimulation therapy according to a treatment schedule; control a telemetry circuitry to transmit communication notification packets at a first notification rate; determine a notification rate change event based on the treatment schedule; and, in response to determining the notification rate change event, control the telemetry circuitry to transmit the communication notification packets at a second notification rate different from the first notification rate.

[0011] Details of one or more examples of the technology disclosed herein are set forth in the accompanying drawings and the following description. Other features, objectives, and advantages of these technologies will be apparent from the specification, drawings, and claims. Attached Figure Description

[0012] Figure 1A This is a conceptual diagram illustrating an example system according to the technology of this disclosure, the example system including an implantable medical device (IMD) configured to deliver electrical stimulation to a patient.

[0013] Figure 1B This is a conceptual diagram of another example system illustrating an example of the technology according to the present disclosure, the example system including an implantable medical device (IMD) configured to deliver electrical stimulation to a patient.

[0014] Figure 2 Figure 1 is a block diagram of an example IMD for delivering electrical stimulation, which is an example of the technology according to this disclosure.

[0015] Figure 3 This is a block diagram of an external device of FIG1 for communicating with a medical device, according to an example of the technology disclosed herein.

[0016] Figure 4 This is a timing diagram of example notification rate changes related to the delivery of electrical stimulation therapy according to the treatment plan.

[0017] Figure 5 This is a time series diagram showing an example of a gradual change in the notification rate associated with changes in the delivery of electrical stimulation therapy, based on the treatment plan.

[0018] Figure 6 This is a flowchart illustrating an example operation of a medical device configured to generate notification groups at different notification rates, according to an example of the technology of this disclosure. Detailed Implementation

[0019] This disclosure describes example apparatus, systems, and techniques related to managing communication between a medical device and an external device configured to provide monitoring and / or treatment to a patient, which may include electrical stimulation therapy (e.g., neuromodulation, such as deep brain stimulation (DBS), spinal cord stimulation (SCS), sacral nerve stimulation (SNS), or peripheral nerve stimulation therapy). For example, the system may be configured to adjust programming parameters of a medical device (e.g., an IMD) using an external device (such as a clinician programmer or a patient programmer). Electrical stimulation therapy may be delivered via multiple electrodes of one or more implanted leads (e.g., cylindrical or paddle-shaped leads) to provide stimulation in the brain, spinal cord, sacral nerve, or tibial nerve. In some examples, electrical stimulation therapy may be delivered via a leadless device. At least one programming parameter may be used to adaptively adjust the electrical stimulation therapy for the patient.

[0020] Bluetooth is an example communication protocol that can be implemented by implantable devices because it enables direct, wireless, short-range or longer-range connections to other implanted or external devices, including mobile phones and tablet computing devices. However, some communication protocols (such as Bluetooth communication) require the IMD to send announcement packets so that the IMD can be discovered and connected to by external devices. This transmission of announcement packets consumes energy and depletes the IMD's battery. This energy consumption reduces battery life and / or requires more frequent recharging of the rechargeable device's battery.

[0021] For relatively low-power stimulation therapies and devices, the impact of notification packet power usage can be particularly noticeable or far-reaching. For example, some therapies (such as sacral and tibial nerve modulation) may only require infrequent stimulation to maintain effective treatment. In this way, IMD battery consumption due to continuous notification packet transmission can be a significant percentage of total battery consumption over time, compared to battery consumption caused by therapy. The magnitude of average communication protocol (e.g., Bluetooth) current consumption is related to the configured notification rate for transmitting Bluetooth notification packets. Faster notification rates (e.g., lower inter-packet intervals) enable faster connectivity between the IMD and external devices, as well as an overall improved user experience. However, faster notification rates also require higher battery current consumption and faster IMD battery depletion.

[0022] As described herein, the IMD can modulate the notification rate of those notification packets to improve communication with external devices while reducing power consumption. In this way, the IMD can control telemetry to mitigate the impact of Bluetooth current consumption caused by notifications on implant lifespan, while still maintaining the desired user experience of the treatment system. The IMD can be triggered to change the communication notification rate by the occurrence of a notification rate change event. This notification rate change event may correspond to one or more events defined by the treatment schedule (e.g., starting or stopping a stimulation treatment session or adjusting one or more parameters defining the stimulation), or may be programmed to occur at some time before or after an event defined by the treatment schedule.

[0023] Generally, an IMD can increase the notification rate for situations where a faster connection to an external device might be desired. These situations may include instances where a user might wish to change an aspect of the IMD's operation, such as requesting a decrease or increase in treatment intensity or duration during a treatment session in which the IMD is delivering stimulation therapy. This increase in the notification rate reduces the time required to establish a connection to an external device (such as a programmer) that the user might wish to use to adjust parameters defining the electrical stimulation therapy. Once treatment for that session is complete, the IMD can mark it as another notification rate change event and accordingly reduce the notification rate to decrease power consumption during periods when the external device is unlikely to interact with the IMD. The IMD can also use other notification rate change events, such as a predetermined time before the start of a treatment session, a time before the end of a treatment session, a time of day, or any situation where the IMD could benefit from increasing or decreasing the communication notification rate. In this way, the IMD can also reduce the notification rate during periods when the user or external device is unlikely to attempt to communicate with the IMD.

[0024] In practice, the notification rate can vary based on several factors. For treatments with non-continuous therapy, such as tibial or sacral nerve modulation, the IMD can be configured to send notification packets at a faster rate to the window just before and during therapy delivery, and switch to a much slower notification rate during periods when therapy is not being delivered. This adjustment of the notification rate facilitates a primary use of rapid connectivity for the main purpose of the patient controller, which would be to adjust stimulation settings (e.g., amplitude, program selection, etc.) to improve comfort or efficacy while stimulation is being delivered. In some examples, increasing the notification rate before stimulation allows the user to prevent the scheduled stimulation from occurring before it is initiated. When stimulation is not being delivered, the external device can still detect notification packets during the slower notification rate period to perform other non-urgent tasks, such as checking the status of the implanted battery or changing the planned therapy start time. In this way, the external device (e.g., a programmer) can be configured to queue these tasks or otherwise synchronize them in the background once a notification packet is detected and a communication session is established, without needing to immediately connect to the IMD.

[0025] Neural modulation telemetry systems can employ one or more communication protocols, such as Bluetooth. ™ (ISM band from 2.402 GHz to 2.48 GHz) or other wireless technology protocols (e.g., RF protocols) are used to enable communication with programming instruments, including proprietary external programmers and off-the-shelf commercial instruments such as cellular phones and tablets. Access to external instruments helps enable recharging and product lifespan, and can help prevent high-risk processes such as replacement surgery for implantable medical devices. The impact of high-frequency protocols on device lifespan can be significant and is directly proportional to the connection and / or notification intervals. Faster notifications result in faster connections and reduced latency, but also lead to higher current consumption and reduced device lifespan.

[0026] Implantable medical devices (IMDs) with limited battery capacity (e.g., primary and / or rechargeable batteries) can benefit from techniques that use varying notification rates to establish connections with instruments and transmit parameters. IMDs can communicate with multiple different instruments (such as patient programmers, clinician programmers, recharger devices (also referred to herein as “chargers”), programming watch chains, or other devices) via wireless protocols (e.g., Bluetooth or another protocol). IMDs may consume significant current to send notification packets and establish connections, and may benefit from reducing the notification rate during periods of communication sessions that are unnecessary, unlikely, or time-insensitive.

[0027] Figure 1AThis is a conceptual diagram illustrating example system 100A, which includes an implantable medical device (IMD) 106 configured to deliver deep brain stimulation (DBS) to a patient 112. While the examples described in this disclosure are generally applicable to devices including external devices and IMDs (such as...) Figure 1B This disclosure pertains to a wide variety of medical devices (System 100B), but for illustrative purposes, will describe applications of such technologies to IMDs, and more specifically, to implantable electrical stimulators (e.g., neurostimulators). More specifically, for illustrative purposes, this disclosure will relate to implantable DBS systems, but is not limited to other types of medical devices or other therapeutic applications of neurostimulation. For example, in some examples, one or more components of System 100A may be configured to deliver one or more of the following: deep brain stimulation (DBS), spinal cord stimulation (SCS), sacral nerve stimulation (SNS) (such as in…). Figure 1B (middle), tibial nerve stimulation (TNS), targeted drug delivery (TDD), pelvic stimulation, gastric stimulation or peripheral nerve field stimulation (PNFS), or any other stimulation therapy that can treat the condition of patient 122.

[0028] In a sense, DBS, or other treatments such as SNS or TNS, can operate in an open-loop manner or alternatively be adaptive, meaning that IMD 106 can adjust, increase, or decrease the magnitude of one or more parameters of DBS in response to changes in patient activity or movement, the severity of one or more symptoms of the patient's disease, the presence of one or more side effects caused by DBS, or one or more sensory signals from the patient. For example, one example of system 100 is a bidirectional DBS system capable of both delivering stimulation and sensing intrinsic neuronal signals. System 100A can provide “closed-loop” treatment, wherein IMD 106 can continuously monitor the state of certain biomarker signals and deliver stimulation according to a pre-programmed routine based on the biomarker signals.

[0029] System 100A can be configured to treat patient conditions such as motor disorders, neurodegenerative damage, mood disorders, or epilepsy in patient 112. Patient 112 is typically a human patient. However, in some cases, treatment system 100A may be applied to other mammalian or non-mammal non-human patients. While this document primarily refers to motor disorders and neurodegenerative damage, in other examples, treatment system 100A may provide treatment to manage symptoms of other patient conditions, such as, but not limited to, epilepsy (e.g., seizures) or mood (or psychological) disorders (e.g., major depressive disorder (MDD), bipolar disorder, anxiety disorder, post-traumatic stress disorder, dysthymia, and obsessive-compulsive disorder (OCD)) and, for example, neural control of prosthetic devices or stimuli to provide sensory feedback to the patient. At least some of these disorders may manifest as one or more patient motor behaviors. Motor disorders or other neurodegenerative damage may include symptoms such as impaired muscle control, motor impairments, or other motor problems such as stiffness, spasticity, bradykinesia, rhythmic hyperkinesia, non-rhythmic hyperkinesia, and akinesia. In some cases, movement disorders can be a symptom of Parkinson's disease. However, movement disorders can be attributed to other patient conditions.

[0030] Example treatment system 100A includes a medical device external device 104, an implantable medical device (IMD) 106, a lead extension 110, and one or more leads 114A and 114B having corresponding sets of electrodes 116, 118. In the example shown in Figure 1, the electrodes 116, 118 of leads 114A, 114B are positioned to deliver electrical stimulation to tissue sites within brain 120, such as deep brain sites beneath the dura mater of the brain 120 of patient 112. In some examples, delivering stimulation to one or more regions of brain 120 (such as the subthalamic nucleus, globus pallidus, or thalamus) can be an effective treatment for managing movement disorders such as Parkinson's disease. Some or all of the electrodes 116, 118 may also be positioned to sense neurobrain signals within the brain 120 of patient 112. In some examples, some of the electrodes 116, 118 may be configured to sense neural brain signals, and the other electrodes 116, 118 may be configured to deliver adaptive electrical stimulation to the brain 120. In other examples, all of the electrodes 116, 118 are configured to sense neural brain signals and deliver adaptive electrical stimulation to the brain 120. In some examples, unipolar stimulation is possible when one electrode is located on the shell of the IMD 106.

[0031] IMD 106 includes a treatment module (e.g., which may include processing circuitry, signal generation circuitry, or other circuitry configured to perform functions attributed to IMD 106), which includes a stimulation generator configured to generate and deliver electrical stimulation therapy to patient 112 via a subset of electrodes 116, 118 of leads 114A and 114B, respectively. The subset of electrodes 116, 118 used to deliver electrical stimulation to patient 112, and in some cases, the polarity of the subset of electrodes 116, 118, may be referred to as a stimulating electrode combination. As described in further detail below, a stimulating electrode combination may be selected (e.g., based on patient condition) for a specific patient 112 and target tissue site. This set of electrodes 116, 118 includes at least one electrode and may include multiple electrodes. In some examples, the multiple electrodes 116 and / or 118 may have complex electrode geometries such that two or more electrodes are located at different locations around the periphery of the respective leads.

[0032] In some examples, neural signals sensed within the brain 120 may reflect changes in current generated by the sum of potential differences throughout the brain tissue. Examples of neural brain signals include, but are not limited to, bioelectrical signals generated by local field potentials (LFPs) sensed in one or more regions of the brain 120. Electroencephalography (EEG) signals or electrocorticography (ECoG) signals are also examples of bioelectrical signals. For example, neurons generate bioelectrical signals; if measured in depth, they are LFP signals; if measured on the cerebral cortex, they are ECoG signals; and if measured on the scalp, they are EEG signals. In other examples, the IMD106 may sense evoked signals, such as evoked compound action potentials (ECAPs), evoked resonant neural activity (ERNAs), etc.

[0033] The electrical stimulation generated by the IMD 106 can be configured to manage various disorders and conditions. In some examples, the stimulation generator of the IMD 106 is configured to generate electrical stimulation pulses via electrodes of a selected combination of stimulation electrodes and deliver such pulses to the patient 112. However, in other examples, the stimulation generator of the IMD 106 can be configured to generate and deliver continuous wave signals, such as sine waves or triangular waves. In either case, the stimulation generator within the IMD 106 can generate electrical stimulation therapy for DBS according to a selected treatment procedure. In examples where the IMD 106 delivers electrical stimulation in the form of stimulation pulses, the treatment procedure may include a set of treatment parameter values ​​(e.g., stimulation parameters), such as the combination of stimulation electrodes used to deliver stimulation to the patient 112, the pulse frequency, the pulse width, and the current or voltage amplitude of the pulse. As previously noted, the electrode combination may indicate the specific electrodes 116, 118 selected for delivering stimulation signals to the tissue of the patient 112, and the corresponding polarity of the selected electrodes. As further described, the electrical stimulation generated by the IMD 106 can generate, for example, burst pulses, interleaved pulses, or simultaneous pulses.

[0034] In some examples, electrodes 116 and 118 may be radially segmented DBS arrays (rDBSA). A radially segmented DBS array refers to electrodes that are segmented radially along the leads. As an example, leads 114A and 114B may include a first set of electrodes arranged circumferentially around leads 114A and 114B, all at the same height level on leads 114A and 114B. Each electrode in the first set is a separate segmented electrode, forming a layer of radially segmented electrode array. Leads 114A and 114B may include a second set of electrodes arranged circumferentially around leads 114A and 114B, all at the same height level on leads 114A and 114B. Each electrode in the first set is a separate segmented electrode, forming a layer of radially segmented electrode array. rDBSA electrodes can facilitate directional stimulation and sensing.

[0035] The IMD 106 can be implanted in a subcutaneous pouch above the clavicle, or alternatively, above or within the skull 122, or at any other suitable site within the patient 112. Generally, the IMD 106 is constructed of a biocompatible material resistant to corrosion and degradation by bodily fluids. The IMD 106 may include an airtight housing to substantially encapsulate components such as the processor, treatment module, and memory.

[0036] like Figure 1A As shown, the implanted lead extension 110 is coupled to the IMD 106 via a connector 108 (also referred to as the connector block or connector of the IMD 106). Figure 1AIn the example, the lead extension 110 extends from the implantation site of the IMD 106 and crosses the neck of the patient 112 to the skull 122 of the patient 112 to enter the brain 120. Figure 1A In the illustrated example, leads 114A and 114B (collectively, “leads 114”) are implanted in the right and left hemispheres of patient 112, respectively (or in some examples, only one hemisphere), to deliver electrical stimulation to one or more regions of brain 120, which may be selected based on patient symptoms or disorders controlled by treatment system 100A. However, specific target tissue sites and stimulation electrodes for delivering stimulation to those target tissue sites may be selected, for example, based on identified patient behavior and / or other sensed patient parameters. For example, a target tissue site may be the location of an oscillating signal source that generates a bioelectrical signal with a signal component in the β band. The stimulation electrodes for delivering stimulation to the target tissue site may be those closest to the oscillating signal source, such as those using the example techniques described in this disclosure. Depending on the clinical application or target tissue / nerve, other implantation sites for leads 114 and IMD 106 are contemplated. For example, in some examples, IMD 106 may be implanted on or within skull 122. In some examples, leads 114A and 114B can be implanted in the same hemisphere, or IMD 106 can be coupled to a single lead implanted in a single hemisphere.

[0037] Existing lead assemblies include so-called "paddle" leads, which carry annular electrodes positioned at different axial locations and an array of electrodes supporting a planar surface. The selection of electrode combinations within the axial leads, within the paddle leads, or between two or more different leads presents a challenge for clinicians. In some examples, more complex lead array geometries can be used. Pelvic stimulation can utilize cuff electrodes wrapped around nerves in the sacrum (or other pelvic bones).

[0038] Although lead 114 is in Figure 1AThe lead 114 is shown coupled to a common lead extension 110, but in other examples, the lead 114 may be coupled to the IMD 106 via a separate lead extension or directly coupled to the connector 108. The lead 114 may be positioned to deliver electrical stimulation to one or more target tissue sites within the brain 120 to manage patient symptoms associated with motor dysfunction in the patient 112. The lead 114 may be implanted to position the electrodes 116, 118 at desired locations within the brain 120 through corresponding holes in the skull 122. The lead 114 may be placed at any location within the brain 120 such that the electrodes 116, 118 can deliver electrical stimulation to target tissue sites within the brain 120 during treatment. For example, the electrodes 116, 118 may be surgically implanted beneath the dura mater of the brain 120 or within the cerebral cortex of the brain 120 through a burr hole in the skull 122 of the patient 112, and electrically coupled to the IMD 106 via one or more leads 114.

[0039] exist Figure 1A In the example shown, electrodes 116 and 118 of lead 114 are shown as ring electrodes. Ring electrodes can be used in DBS applications because they are relatively easy to program and can deliver an electric field to any tissue adjacent to electrodes 116 and 118. In other examples, electrodes 116 and 118 may have different configurations. For example, at least some of the electrodes 116 and 118 of lead 114 may have a complex electrode array geometry capable of generating a shaped electric field. The complex electrode array geometry may include multiple electrodes (e.g., partially ring-shaped or segmented electrodes) around the outer periphery of each lead 114, rather than a single ring electrode. In this way, electrical stimulation can be directed from lead 114 in a specific direction to enhance therapeutic efficacy and reduce potential adverse side effects due to stimulation of large amounts of tissue.

[0040] In some examples, the housing of IMD 106 may include one or more stimulation and / or sensing electrodes. In some examples, lead 114 may have, in addition to, Figure 1A Shapes other than the elongated cylinder shown. For example, lead 114 can be a paddle lead, a spherical lead, a flexible lead, or any other type of shape that is effective in treating patient 112 and / or minimizing the invasiveness of lead 114.

[0041] The IMD 106 includes a memory for storing multiple treatment procedures, each defining a set of treatment parameter values. In some examples, the IMD 106 can select a treatment procedure from the memory based on various parameters, such as sensed patient parameters and identified patient behaviors. The IMD 106 can generate electrical stimulation based on the parameters of the selected treatment procedure to manage patient symptoms associated with movement disorders.

[0042] External device 104 wirelessly communicates with IMD 106 as needed to provide or retrieve treatment information. External device 104 is an external computing device that a user (e.g., a clinician and / or patient 112) can use to communicate with IMD 106. For example, external device 104 could be a clinician programmer used by the clinician to communicate with IMD 106 and program one or more treatment procedures for IMD 106. Alternatively, external device 104 could be a patient programmer that allows patient 112 to select procedures and / or view and modify treatment parameters. Clinician programmers may include more programming features than patient programmers. In other words, only clinician programmers may allow for more complex or sensitive tasks to prevent untrained patients from making unintended changes to IMD 106. External device 104 can be any type of computing device, such as a proprietary device, cellular phone, smartphone, tablet computer, laptop computer, or any other type of computing device. Generally, external device 104 may include a user interface for receiving input from the user. In some examples, external device 104 may be configured to transfer information between IMD 106 and different external devices, but external device 104 may or may not have a user interface for programming. Instead, external device 104 may receive programming commands from different external devices (e.g., servers or other computing devices including user interfaces) and send those programming commands to IMD 106 and / or receive information from IMD 106 and further send that information to different external devices.

[0043] When the external device 104 is configured for use by a clinician, it can be used to send initial programming information to the IMD 106. This initial information may include hardware information such as the type and electrode arrangement of the leads 114, the location of the leads 114 within the brain 120, the configuration of the electrode arrays 116, 118, an initial procedure defining treatment parameter values, and any other information the clinician wishes to program into the IMD 106. The external device 104 may also be able to perform functional tests (e.g., measuring the impedance of the electrodes 116, 118 of the leads 114).

[0044] Clinicians can also store treatment procedures within the IMD 106 using external device 104. During a programming session, the clinician can identify one or more treatment procedures that provide effective treatment to the patient 112 to address symptoms associated with the patient's condition, and in some cases, symptoms specific to one or more different patient states (such as sleep, movement, or rest). For example, the clinician can select one or more combinations of stimulation electrodes to deliver stimulation to the brain 120. During a programming session, the clinician can assess the efficacy of a particular procedure based on feedback provided by the patient 112 or based on one or more physiological parameters of the patient 112 (e.g., muscle activity, muscle tone, stiffness, tremor, etc.). Alternatively, patient behavior identified based on video information can be used as feedback during the initial programming session and subsequent programming sessions. External device 104 can assist clinicians in creating / identifying treatment procedures by providing a system of methods for identifying potentially beneficial treatment parameter values.

[0045] However, in some examples, the IMD 106 or external device 104 (e.g., clinician programmer, patient programmer, recharger, programmer watchband, etc.) may automatically determine electrode configuration and treatment parameters, individually or in combination. For example, the medical device may determine which electrodes to use for stimulation based on which electrodes are closest to the target tissue. In some examples, the external device 104 may output information indicating the selected electrode configuration for stimulation and the determined stimulation amplitude or other treatment parameters for review and confirmation by a clinician or physician before the IMD 106 delivers treatment with the selected electrode configuration and the determined stimulation amplitude.

[0046] External device 104 can also be configured for use by patient 112. When configured as a patient programmer, external device 104 may have limited functionality (compared to a clinician programmer) to prevent patient 112 from altering critical functions of IMD 106 or from using it in a way that could be harmful to patient 112. In this way, external device 104 may only allow patient 112 to adjust the values ​​of certain treatment parameters or to set the available range of values ​​for specific treatment parameters. For example, external device 104 may only allow patient 112 to adjust the amplitude or intensity (through a combination of amplitude, pulse width, and / or pulse rate).

[0047] External device 104 may also provide indications to patient 112 when treatment is being delivered, when patient input triggers a treatment change, or when the power supply within external device 104 or IMD 106 needs to be replaced or recharged. For example, external device 104 may include alarm LEDs and / or a touchscreen that can send messages to patient 112 via a programmer display, generating audible or haptic prompts to confirm receipt of patient input, such as indicating patient status or manually modifying treatment parameters.

[0048] The treatment system 100A can be implemented to provide chronic stimulation therapy to patient 112 over a period of months or years. However, system 100A can also be used on a trial basis to evaluate treatment before full implantation. If implemented interim, some components of system 100A may not be implanted in patient 112. For example, patient 112 may be fitted with an external medical device, such as a trial stimulator, instead of IMD 106. The external medical device may be coupled to a percutaneous lead or implanted lead via a percutaneous extension. If the trial stimulator instructs the DBS system 100A to provide effective treatment to patient 112, the clinician may implant a chronic stimulator in patient 112 for relatively long-term treatment.

[0049] In some examples, IMD 106 may be configured to provide electrical stimulation for the treatment of a patient condition that complements the medication provided to patient 122. While examples of using IMD 106 in conjunction with stimulation are described, these techniques are not limited and may be applied to examples where stimulation is not provided. For example, IMD 106 may not provide stimulation and treatment for the patient condition of patient 122, but may provide it via medication or in conjunction with other techniques. For example, IMD 106 may use LFP to determine medication for one disorder of patient 122 and may apply stimulation for another disorder of patient 122. For example, patient 122 may have a dual condition similar to Parkinson's disease and dystonia, and lead 114 may be positioned to treat both Parkinson's disease and dystonia. A single IMD 106 may listen to / monitor different LFP bands to view various medications or disease states via the same lead / same hemisphere or different hemispheres.

[0050] According to the technology disclosed herein, IMD 106 can be configured to change the notification rate (e.g., Bluetooth) of a medical device (e.g., an implanted medical device) in response to a triggering event (such as a notification rate change event). ™(Announcement or other announcement). External device 104 (e.g., clinician programmer, patient programmer, recharger, programmer watchchain, etc.) may be configured to detect announcement packets sent from IMD 106 and, in response, establish a communication session with IMD 106. However, IMD 106 may not need to send announcement packets during various time periods during which external device 104 is unlikely to need to communicate with IMD 106. Instead, the user experience can be improved by increasing the announcement rate during time periods when the user may expect to communicate with IMD 106 using external device 104. Some of these times may include before stimulation delivery and / or during a treatment session. A treatment session may refer to a period of time in which IMD 106 is programmed to deliver electrical stimulation pulses at a predetermined frequency, a predetermined frequency of pulse bursts, a number of pulse bursts, or other active periods in which IMD 106 delivers stimulation pulses according to one or more procedures that define pulse delivery that can be separated by one or more intervals. The IMD 106 can stop or terminate treatment sessions to provide longer interruptions during treatment, which can last for approximately minutes, hours, days, or even weeks. In this way, system 100A enables intelligent connectivity for optimized battery life driving the IMD 106, as well as an optimized, personalized user experience that reduces connection latency when needed and power consumption where possible. The techniques described herein help allow the IMD 106 to achieve its optimal performance level for a superior patient experience while extending device life. The techniques described herein also help allow patients 102 to use the IMD 106 for longer periods, thereby reducing the risk of needing to change procedures.

[0051] Example IMD 106 may include: telemetry circuitry configured to transmit communication notification packets; stimulation generation circuitry configured to deliver electrical stimulation therapy according to a treatment schedule; and processing circuitry configured to control the telemetry circuitry to adjust or modulate the notification rate of the notification packets. For example, the processing circuitry may be configured to: control the telemetry circuitry to transmit communication notification packets at a first notification rate; determine a notification rate change event based on the treatment schedule; and, in response to determining the notification rate change event, control the telemetry circuitry to transmit communication notification packets at a second notification rate different from the first notification rate. In some examples, the communication notification packets may be or include Bluetooth notification packets.

[0052] A treatment schedule may specify instructions for when the IMD 106 delivers treatment according to one or more treatment procedures. A treatment procedure may specify a set of stimulation parameters that define the delivered electrical stimulation, such as electrode combination, current or voltage amplitude, pulse width, pulse frequency, duty cycle, burst frequency, burst duration, pulse shape, etc. Therefore, the IMD 106 may deliver stimulation therapy defined by one or more treatment procedures during a treatment session. The treatment schedule may specify when the IMD 106 begins and / or ends a treatment session. In some examples, the treatment schedule may be or include a treatment calendar that specifies the delivery of electrical stimulation therapy on specific calendar days of the treatment calendar. For example, the treatment calendar may specify that the IMD 106 should perform treatment sessions every Tuesday and Friday of the week, or during specific calendar days of a month, and at specific times on those specified days. In other examples, the treatment schedule includes treatment cycles that define a repetitive pattern of delivery and non-delivery of electrical stimulation therapy. For example, a treatment cycle may specify that a treatment session will be repeated every predetermined number of hours, or will be initiated again after a predetermined interval from the end of the last treatment session. In some examples, the treatment schedule may include a combination of a treatment calendar and treatment cycles. In other examples, the treatment schedule may include, or be enhanced by, sensed patient parameters that trigger the delivery or termination of stimulus treatment.

[0053] A notification rate change event can be any event or trigger that causes the IMD 106 to change its notification rate. As discussed above, it may be beneficial to send notification packets at a higher notification rate during the delivery of stimulation therapy. In this way, the notification rate change event can be the start of the delivery of electrical stimulation therapy according to a treatment schedule. In some examples, the notification rate change event can be a communication start time, which is defined as occurring at a predetermined amount of time before the delivery of electrical stimulation therapy according to the treatment schedule begins. By increasing the notification rate at a communication start time that occurs before stimulation delivery, the IMD 106 can be able to quickly establish communication with the external device 104, allowing the user to delay or change the stimulation before the start of electrical stimulation therapy during a treatment session.

[0054] In some examples, the second notification rate is higher than the first notification rate to enable faster communication. In this way, the IMD 106 can be configured to control the telemetry circuitry to send communication notification packets at the second notification rate during at least a portion of the delivery of electrical stimulation therapy. Then, after the delivery of electrical stimulation therapy is suspended, the IMD 106 can control the telemetry circuitry to send communication notification packets at the first notification rate or a slower notification rate during periods of non-delivery of electrical stimulation therapy (e.g., once the treatment session has been terminated).

[0055] The IMD 106 can switch between two or more different notification rates. As discussed above, the notification rate during and / or before stimulation therapy can be higher than the notification rate during periods when stimulation therapy is about to end or has already ended. A higher notification rate generally refers to a higher frequency of notification packet transmission. Generally, a higher notification rate also indicates a shorter inter-packet interval. However, in some examples, where some notification packets involve longer transmission times than others, the inter-packet interval may not always indicate the notification rate. In some cases, a lower notification rate can be zero to indicate that no notification packets are transmitted during that period. In some examples, the IMD 106 can select between three or more different notification rates. These different notification rates can be selected for different situations, such as different notification rate change events. However, when a communication session is anticipated (e.g., user input is expected) or desired (e.g., IMD 106 has patient-related alerts that need to be sent to clinicians and / or patients), IMD 106 may automatically change to a higher notification rate in response to external device 104 not initiating a communication session. As just some examples, this escalation of the notification rate may be temporary for a predetermined amount of time, decreasing back to the normal notification rate after a successful communication session, or decreasing back to the normal notification rate after the treatment session ends.

[0056] In some examples, IMD 106 can change between the first and second notification rates immediately, such as in a single step from the first to the second notification rate. In other examples, IMD 106 can be configured to gradually change from the initial notification rate to the target notification rate over time via multiple intermediate notification rates between the initial notification rate and the target second notification rate. This gradual change in the notification rate can be in the form of a step-like structure of these intermediate notification rates. The steps can be equal or different magnitudes (and / or the intervals between each step can be different) to form different slopes, such as logarithmic or exponential curves. Alternatively, the notification rate can also be gradually changed according to a smoothing function. This gradual change can be used to increase or decrease the notification rate. In some examples, the rate of change of increasing the notification rate can be different from that of decreasing the notification rate.

[0057] Generally, the notification rate used to send notification packets can be between approximately 0.0005 Hz and 10 Hz, or between approximately 0.002 Hz and 5 Hz. In some examples, lower notification rates may have frequencies between approximately 0.00333 Hz and 0.05 Hz (e.g., inter-packet intervals between approximately 5 minutes and 20 seconds). In some examples, higher notification rates may have frequencies between approximately 0.1 Hz and 10 Hz (e.g., inter-packet intervals between approximately 10 seconds and 0.1 seconds), or frequencies between approximately 1 Hz and 5 Hz (e.g., inter-packet intervals between approximately 1 second and 0.2 seconds). These are merely examples of notification rates, but other ranges and specific rates may vary for different situations and / or different patients. In some examples, IMD 106 may set limits on slower notification rates, such as approximately several minutes or several hours. At these slow notification rates, IMD 106 can alternatively disable the transmission of notification packets because external device 104 will find it unlikely that events such as detecting low-frequency notification packets will occur.

[0058] In some examples, the IMD 106 may enter a sleep mode in which the telemetry circuitry and / or processing circuitry enter a low-power mode and cease sending (or send at very long intervals, such as approximately several minutes or hours) notification packets. The IMD 106 may monitor an internal timer and exit the sleep mode to resume sending notification packets once it has exited the sleep mode. In other examples, the IMD 106 may require stimulation from another device. For example, the IMD 106 may receive a wake-up signal via a second communication mode (different from the notification packet communication mode) during a period in which the IMD 106 controls the telemetry circuitry to suppress the transmission of any communication notification packets. In other examples, the wake-up signal may be generated by different sensors or elements of the IMD 106 in response to a corresponding sensed change. For example, a magnetic field detector (e.g., a Hall sensor) may detect an external magnet placed by a user near the IMD 106, and the IMD 106 may wake up in response to receiving such a signal generated by the magnetic field detector. Other sensor signals that the IMD 106 can monitor to wake up communication may include outputs from an accelerometer, a sound sensor, or a temperature sensor. In response to receiving a wake-up signal, the IMD 106 can control the telemetry circuitry to initiate the transmission of communication announcement packets at a first announcement rate. In some examples, the IMD 106 may immediately transmit announcement packets at a higher announcement rate in response to receiving a wake-up signal. The IMD 106 may skip lower announcement rates or operations, such that the IMD 106 does not transmit announcement packets due to being in sleep mode, or transmit announcement packets at a higher announcement rate. In some examples, the announcement packet communication protocol may be Bluetooth, and the second communication mode may be an inductive communication protocol.

[0059] Figure 1B This is a conceptual diagram of another example system 100B illustrating an example of the technology according to this disclosure, the example system including an implantable medical device (IMD) 130 configured to deliver electrical stimulation to a patient. Figure 1B In one example, system 100B may be similar to system 100A and includes an implantable medical device (IMD) 130 that may be similar to IMD 106. IMD 130 may be configured to deliver treatment to target tissue and / or sense physiological signals from target tissue. Target tissue may include or may be located near the spinal cord 128 and / or pelvic nerves 136 (e.g., pudendal nerve or sacral nerve), or any other nerve or muscle tissue that may be stimulated or from which physiological signals of patient 112 may be sensed via lead 134 (coupled to IMD 130 via connector 132). Lead 134 may carry multiple electrodes 138 at its distal end. IMD 130 may provide nerve stimulation to treat symptoms of patient 112, such as pain, fecal or urinary incontinence, erectile dysfunction, or other sexual dysfunctions. Thus, in one example, IMD 130 may be configured to provide sacral nerve stimulation.

[0060] In other examples, the IMD 130 can be configured to deliver electrical stimulation to other nerves that can alleviate symptoms associated with pelvic floor disorders. In one example, the IMD 130 can be configured to deliver electrical stimulation to the tibial nerve (e.g., tibial nerve stimulation). The electrode 138 can be implanted near a desired portion of the tibial nerve, which may be located in the leg and / or ankle of the patient 112.

[0061] Figure 2 Figure 1 is a block diagram of an example IMD for delivering electrical stimulation, based on an example of the technology disclosed herein. Figure 2 In the example shown, IMD 106 includes processing circuitry 210, memory 211, stimulus generation circuitry 202, sensing circuitry 204, telemetry circuitry 208, and power supply 220. Each of these circuits may be or include circuitry configured to perform the functions attributed to each respective circuit. Memory 211 may include any volatile or non-volatile medium, such as random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), ferroelectric RAM (FRAM), electrically erasable programmable ROM (EEPROM), and flash memory. Memory 211 may store computer-readable instructions that, when executed by processing circuitry 210, cause IMD 106 to perform various functions. Memory 211 may be a storage device or other non-transitory medium.

[0062] exist Figure 2In the example shown, memory 211 stores electrical stimulation information 214. Electrical stimulation information 214 may include program parameters (e.g., a set of treatment parameters), such as the combination of stimulating electrodes, electrode polarity, current or voltage amplitude, pulse width, and pulse rate. In some examples, individual treatment programs may be stored as treatment groups that define a set of treatment programs in which stimulation can be generated during a treatment session in which stimulation therapy is delivered. Stimulation signals defined by the treatment programs of a treatment group may be delivered together on an overlapping or non-overlapping (e.g., time-staggered) basis.

[0063] Therefore, in some examples, the stimulation generation circuit 202 may generate an electrical stimulation signal according to the electrical stimulation parameters indicated above, which may be examples of programmed parameters. Other ranges of treatment parameter values ​​may also be useful and may depend on the target stimulation site within the patient 112. Although stimulation pulses are described, the stimulation signal may have any form, such as a continuous-time signal (e.g., a sine wave). The stimulation generation circuit 202 is an example of a treatment circuit configured to deliver treatment from the IMD 106. In other examples, the treatment circuit may include circuitry configured to control and / or deliver other treatments, such as a fluid containing one or more drugs (e.g., insulin, analgesics, behavioral drugs, etc.). In this way, the treatment circuitry may control one or more pumps to deliver drugs from the IMD 106. The treatment circuitry and IMD 106 may be used additionally or alternatively to deliver other types of treatment.

[0064] Processing circuitry 210 may include fixed-function processing circuitry and / or programmable processing circuitry, and may include one or more of the following: a microprocessor, a controller, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), discrete logic circuitry, or any other processing circuitry configured to provide the functions attributed to processing circuitry 210, which may herein be embodied as firmware, hardware, software, or any combination thereof. Processing circuitry 210 may control stimulation generation circuitry 202 according to treatment program 214 stored in memory 211 to apply specific stimulation parameter values, such as voltage or current amplitude, pulse width, and / or pulse frequency, specified by one or more programs in the program.

[0065] exist Figure 2In the example shown, the set of electrodes 116 includes electrodes 116A, 116B, 116C, and 116D, and the set of electrodes 118 includes electrodes 118A, 118B, 118C, and 118D. Processing circuitry 210 can control individual voltage or current sources and receivers coupled to the respective electrodes 116, 118, which serve as cathodes or anodes, to deliver stimulation signals to patient tissue. In other examples, processing circuitry can control switching circuitry to apply stimulation signals generated by stimulation generation circuitry 202 to selected combinations of electrodes 116, 118.

[0066] The stimulation generation circuit 202 can be a single-channel or multi-channel stimulation generator. Specifically, the stimulation generation circuit 202 can be capable of delivering a single stimulation pulse, multiple stimulation pulses, or a continuous signal at a given time via a single electrode combination, or multiple stimulation pulses at a given time via multiple electrode combinations. Alternatively, as mentioned above, the stimulation generation circuit 202 may include multiple voltage or current sources and receivers coupled to corresponding electrodes to drive the electrodes as cathodes or anodes simultaneously or at different times. In this example, the IMD 106 may not require the time-interleaved multiplexing functionality of the switching circuitry for stimulation via different electrodes. However, in other examples, the stimulation generation circuit 202 may be configured to deliver multiple channels on a time-interleaved basis. For example, the switching circuitry may be used to time-divide the output of the stimulation generation circuit 202 across different electrode combinations at different times to deliver a program or channel of multiple stimulation energies to the patient 112.

[0067] Telemetry circuit 208, under the control of processing circuit 210, supports the use of one or more communication protocols (e.g., Bluetooth). ™ Wi-Fi ™Wireless communication between the IMD 106 and the external device 104 or another computing device can be achieved via Near Field Communication (NFC), Near Field Magnetic Induction (NFMI), Long Term Evolution (LTE / 5G), or MedRadio (MICS: Medical Implantable Communication Service, MEDS: Medical External Device Service, MBAD: Medical Body Area Network). In some examples, telemetry circuitry 208 supports telemetry frequencies that may correspond to high frequencies or radio frequencies, such as those established via Bluetooth, Wi-Fi, Near Field Communication (NFC), 175 kHz inductive telemetry, or MICS. Telemetry circuitry 208 can be configured to receive inductive stimuli. As an update to the program (e.g., at least one program parameter), processing circuitry 210 of the IMD 106 can receive values ​​of various stimulation parameters (such as magnitudes and electrode combinations) from the external device 104 via telemetry circuitry 208. Updates to the treatment program can be stored in the treatment program 214 portion of memory 211. Telemetry circuitry 208 in IMD 106, as well as telemetry modules in other devices and systems described herein (such as external device 104), can communicate via radio frequency (RF) communication technologies (e.g., Bluetooth, Wi-Fi, near field communication (NFC), or MICS). Furthermore, telemetry circuitry 208 can communicate with external medical device 104 via proximal sensing interaction between IMD 106 and external device 104. Therefore, telemetry circuitry 208 can transmit information to external device 104 on a continuous basis, at periodic intervals, or upon request from IMD 106 or external device 104.

[0068] Telemetry circuit 208 may periodically output notification packets for connection as described herein at notification intervals (e.g., less than 100 ms, 100 ms to 500 ms, 1 second, greater than 1 second, etc.) or notification rates. Notification packets may include information about how to connect to the notification device, such as one or more of the following: (1) the Media Access Control (MAC) address of the medical device and external device; (2) the real-time point at which transmission begins; (3) an indication of the start frequency; (4) an indication of the hop set; (5) the connection interval; or (6) the connection delay. In some examples, telemetry circuit 208 may receive notification packets and use the received notification (e.g., using the start frequency and hop set of the received notification packet) to connect to another device (e.g., external device 104). Notification instruction 215 may store instructions related to changing the notification rate of IMD 106, such as different notification rates, one or more notification rate change events, or any other instructions that IMD 106 will utilize to implement the functionality described herein.

[0069] Power source 220 delivers operating power to the various components of IMD 106. Power source 220 may include a small rechargeable or non-rechargeable battery and power generation circuitry to generate operating power. Recharging is achieved via proximal inductive interaction between an external charger and an inductive charging coil within IMD 106. In some examples, the power requirement may be small enough to allow IMD 106 to utilize patient movement and implement kinetic energy harvesting to trickle charge a rechargeable battery. In other examples, conventional batteries may be used for a limited time.

[0070] The processing circuitry 210 of the IMD 106 can sense one or more bioelectrical signals of the brain 120 of the patient 112 via electrodes 116, 118 inserted along lead 114 (and sensing circuitry 204). Furthermore, the processing circuitry 210 of the IMD 106 can deliver electrical stimulation therapy to the patient 112 via electrodes 116, 118 (and stimulation generation circuitry 202) based on the sensed one or more bioelectrical signals of the brain 120. Adaptive DBS therapy is defined by electrical stimulation information 214. For example, electrical stimulation information 214 may include current amplitude (for a current control system) or voltage amplitude (for a voltage control system), pulse frequency or frequency, pulse width, or the number of pulses per cycle. In an example where electrical stimulation is delivered according to a “burst” of pulses or a series of electrical pulses defined by “on time” and “off time”, one or more parameters may also define one or more of the number of pulses per burst, on time, and off time. The processing circuit 210 delivers adaptive DBS to the patient 112 via electrodes 116, 118, and can adjust one or more parameters defining the electrical stimulation based on corresponding parameters of the one or more bioelectrical signals sensed in the brain 120.

[0071] In some examples, processing circuitry 210 can continuously measure one or more bioelectrical signals in real time. In other examples, processing circuitry 210 can sample one or more bioelectrical signals periodically according to a predetermined frequency or after a predetermined amount of time. In some examples, processing circuitry 210 can periodically sample the signals at a frequency of approximately 150 Hz.

[0072] Telemetry circuit 208 can be configured to output notification packets, such as notifications for wireless communication sessions or notifications conforming to another protocol. For example, telemetry circuit 208 can output notification packets at a notification rate (or notification interval). The notification rate may include the Bluetooth Low Energy notification rate. Telemetry circuit 208 can authenticate external device 104. For example, telemetry circuit 208 can output notifications or notification packets that external device 104 or another device is listening for in order to know whether a device for exchanging communications is present. In some examples, telemetry circuit 208 can output notification packets in response to stimuli and / or can periodically output notifications using a notification rate (e.g., with random delay). Telemetry circuit 208 may benefit from sending notifications at a lower notification rate or a longer interval when the notification is acquiring energy. The notification may include security information for the communication session and / or connectivity information for the communication session.

[0073] According to the technology disclosed herein, the IMD 106 enables optimized lifespan of the power supply 220 (e.g., a battery) and intelligent connectivity for an optimized, personalized user experience. This intelligent connectivity reduces connection latency of the telemetry circuitry 208 when communication with an external device 104 is likely, and reduces power consumption when communication is unlikely. The technology described herein helps allow the IMD 106 to achieve optimal performance levels for a superior patient experience while extending device lifespan. The technology described herein helps allow patients 122 to use the IMD 106 for longer periods, thus reducing the risk of a single battery replacement procedure or alleviating the patient's recharging burden by utilizing the rechargeable battery in the IMD 106.

[0074] Figure 3 This is a block diagram of the external device 104 in Figure 1. Although the external device 104 is generally described as a handheld device, it can be a larger portable device or a more fixed device. Furthermore, in other examples, the external device 104 may be included as part of an external charging device or include the functionality of an external charging device. Figure 3 As illustrated, external device 104 may include processing circuitry 310, memory 311, user interface 302, telemetry circuitry 308, and power supply 320. Throughout this disclosure, memory 311 may store instructions that, when executed by processing circuitry 310, enable processing circuitry 310 and external device 104 to provide functionality attributable to external device 104. Each of these components or modules may include circuitry configured to perform some or all of the functionality described herein. For example, processing circuitry 310 may include processing circuitry configured to perform the processes discussed herein.

[0075] Generally, external device 104 includes any suitable hardware arrangement, individually or in combination with software and / or firmware, to perform the techniques belonging to external device 104 and IMD 106, including processing circuitry 310, user interface 302, and telemetry circuitry 208. In various examples, external device 104 may include one or more processors, which may include fixed-function processing circuitry and / or programmable processing circuitry, such as those formed by, for example, one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry, and any combination of such components. In various examples, external device 104 may also include memory 311, such as RAM, ROM, PROM, EPROM, EEPROM, flash memory, hard disk, CD-ROM, containing executable instructions for causing one or more processors to perform actions belonging to them. Furthermore, although processing circuitry 310 and telemetry circuitry 308 are described as separate modules, in some examples, processing circuitry 310 and telemetry circuitry 308 may be functionally integrated with each other. In some examples, the processing circuitry 310 and the telemetry circuitry 308 correspond to separate hardware units, such as ASICs, DSPs, FPGAs, or other hardware units. Although the telemetry circuitry 308 is described as being located within the external device 104, in some examples, aspects of the telemetry circuitry 308 (e.g., configuring the medical device to announce at notification intervals or initiating communication sessions) may be performed by the telemetry circuitry 308 external to the external device 104 (e.g., in an intermediate device).

[0076] Memory 311 (e.g., a storage device) may store instructions that, when executed by processing circuitry 310, enable processing circuitry 310 and external device 104 to provide the functionality attributed to external device 104 throughout this disclosure. For example, memory 311 may include instructions that enable processing circuitry 310 to retrieve a parameter set from memory or receive user input and send a corresponding command to IMD 106, or instructions for any other functionality. Furthermore, memory 311 may include multiple programs, each including a parameter set defining the stimulation therapy.

[0077] User interface 302 may include buttons or a keypad, lights, a speaker for voice commands, and a display (such as a liquid crystal (LCD), a light-emitting diode (LED), or an organic light-emitting diode (OLED)). In some examples, the display may be a touchscreen. User interface 302 may be configured to display any information related to the delivery of stimulation therapy, represented patient behavior, sensed patient parameter values, patient behavior criteria, or any other such information. User interface 302 may also receive user input. Input may be, for example, pressing a button on a keypad or selecting an icon from a touchscreen.

[0078] One or more sensors 301 may include one or more accelerometers 340, a light sensor 342, and a microphone 344. For example, one or more accelerometers 340 may be configured to determine information indicating movement of the external device 104. This information may include one or more of acceleration in the x-direction, acceleration in the y-direction, or acceleration in the z-direction. The x-direction may be perpendicular to both the y-direction and the z-direction. Although... Figure 3 The example uses an accelerometer 340, but in some examples, the external device 104 may additionally or alternatively include a gyroscope capable of detecting movement and / or generating motion information. A light sensor 342 may be configured to determine light information (e.g., the ambient light level of the environment detected by the light sensor 342). A microphone 344 may be configured to determine sound information (e.g., the ambient sound level of the environment detected by the microphone 344). For example, the microphone 344 may detect speech (e.g., from the patient 122 or the patient 122's caregiver).

[0079] Telemetry circuit 308 can support wireless communication between IMD 106 and external device 104 under the control of processing circuit 310. Telemetry circuit 308 can also be configured to communicate with another computing device via wireless communication technology or directly via a wired connection. In some examples, telemetry circuit 308 provides wireless communication via RF or near-side sensing media. In some examples, telemetry circuit 308 includes an antenna, which can take various forms, such as an internal antenna or an external antenna.

[0080] Examples of local wireless communication technologies that can be used to facilitate communication between external device 104 and IMD 106 include RF communication according to 802.11 or the Bluetooth specification set (e.g., classic Bluetooth protocol, Bluetooth High Speed ​​protocol, and Bluetooth Low Energy (BLE) protocol) or other standard or proprietary telemetry protocols. In this way, other external devices can be able to communicate with external device 104 without establishing a secure wireless connection. While the examples described herein may refer to the connection as being established using the Bluetooth protocol and using Bluetooth-compliant announcements, other known and future protocols may be used. For example, the techniques described herein for establishing a connection between IMD 106 and external device 104 may conform to any RF communication protocol and / or may use any telemetry frequency.

[0081] Telemetry circuit 308 may receive notification packets, for example, from IMD 106, and use the received notification packets to connect to another device (e.g., IMD 106). The notification packets may include information about how to connect to the notification device, such as one or more of the following: (1) the Media Access Control (MAC) address of the medical device and external device; (2) the real-time point at which transmission begins; (3) an indication of the starting frequency; (4) an indication of the hop set; (5) a connection interval; or (6) a connection delay. For example, telemetry circuit 308 may use the starting frequency and hop set indicated by a notification broadcast by medical device 106 (e.g., on a set of notification channels) to establish a connection with medical device 106. In some examples, telemetry circuit 308 may periodically output notifications with optional random delays (e.g., less than 100 ms, 100 ms to 500 ms, 1 second, greater than 1 second, etc.). In this example, other devices can connect to telemetry circuit 308 using announcements output by telemetry circuit 308.

[0082] In some examples, processing circuitry 310 may define parameters for electrical stimulation therapy stored in memory 311 to deliver adaptive DBS to patient 112. In one example, processing circuitry 310 of external device 104 commands IMD 106 via telemetry circuitry 308 to deliver electrical stimulation therapy via leads 114 to electrodes 116, 118.

[0083] Telemetry circuit 308 can be configured to initiate a communication session using announcement packets. For example, telemetry circuit 308 can receive announcements at a specified announcement rate (e.g., from telemetry circuit 208). The announcement rate may include the Bluetooth Low Energy announcement rate. The announcement packets may include security information and / or connectivity information for the communication session. For example, telemetry circuit 308 may use the security information and / or connectivity information of the communication session announced by IMD 106 at the announcement rate to establish a communication session. Announcement instructions 315 may include any instructions required by external device 104 to perform the communication described herein.

[0084] Figure 4 and Figure 5 These are timing diagrams of just two different examples of how a medical device can change the notification rate based on a treatment schedule. Figure 4 This is a timing diagram 400 showing an example of a change in the notification rate associated with the delivery of electrical stimulation therapy according to the treatment plan.

[0085] like Figure 4As shown in the example, trace 422 indicates whether the stimulation therapy is on or off. Trace 422 does not indicate a single stimulation pulse. Instead, one or more stimulation procedures may be defined as the delivery of multiple stimulation pulses (such as one or more pulse trains) during the on period of stimulation therapy indicated by trace 422.

[0086] Trace 420 indicates the notification rate at which notification packets are sent by an IMD (such as IMD 106). Prior to time 402, IMD 106 may send notification packets at a first notification rate. In this example, a notification rate change event may include the start or stop of stimulation therapy. Therefore, the change in notification rate is based on the treatment schedule. Time 402 corresponds to the start of stimulation therapy (e.g., a treatment session). Therefore, IMD 106 detects a notification rate change event corresponding to the start of stimulation therapy at time 402 and responds by changing from the first notification rate to a higher second notification rate.

[0087] The IMD 106 may continue at a second notification rate until the treatment schedule indicates that the stimulation treatment will be turned off or terminated at time 404. In response to detecting this notification rate change event at time 404, the IMD 106 reduces the notification rate back to the first notification rate. In some examples, the IMD 106 may completely shut down the transmission of notification packets at time 406, which may be a predetermined time after the termination of the stimulation treatment. At time 406, the IMD 106 may reduce the notification rate to zero to conserve power.

[0088] IMD 106 may continue in this very low-power mode until another notification rate change event occurs. In some examples, this notification rate change event may be caused by a wake-up signal sent from another device (e.g., external device 104) via a communication protocol different from the communication protocol used for notification grouping. In other examples, the notification rate change event may be an interval prior to the expected start of the next stimulation session according to the treatment schedule. In any case, IMD 106 may change the notification rate back to the first notification rate at time 408 before the next stimulation session at time 410. Between times 408 and 410, the user may expect to establish a communication session with IMD 106 to modify one or more parameters defining the next stimulation treatment, delay the next stimulation treatment, or even cancel the next stimulation treatment. If the notification rate is zero before time 410, external device 104 may not be able to communicate any changes to the upcoming stimulation treatment until after it begins at time 410. IMD 106 may continue to operate in this manner over time to adjust the notification rate based on the treatment schedule.

[0089] Generally, the notification rate used to send notification packets can be between about 0.0005 Hz and 10 Hz, or between about 0.002 Hz and 5 Hz. In some examples, the first notification rate may have a frequency between about 0.00333 Hz and 0.05 Hz (e.g., an inter-packet interval between about 5 minutes and 20 seconds). In some examples, the second notification rate may have a frequency between about 0.1 Hz and 10 Hz (e.g., an inter-packet interval between about 10 seconds and 0.1 seconds), or a frequency between about 1 Hz and 5 Hz (e.g., an inter-packet interval between about 1 second and 0.2 seconds). These are merely examples of notification rates, but other ranges and specific rates may vary for different situations and / or different patients. In some examples, when changing the notification rate from the current notification rate to the target notification rate, IMD 106 may gradually increase and / or gradually decrease the notification rate. When increasing or decreasing the notification rate, the rate of change of the notification rate may be different or the same.

[0090] Figure 5 This is an example of a gradual timeline diagram 500 showing changes in the notification rate associated with changes in the delivery of electrical stimulation therapy according to the treatment plan. Figure 5 Examples can be similar to Figure 4 The timing diagram is 400, but IMD 106 allows for gradual changes in the notification rate. For example... Figure 5 As shown in the example, trace 522 indicates whether the stimulation therapy is on or off. Trace 522 does not indicate a single stimulation pulse. Instead, one or more stimulation procedures may be defined as the delivery of multiple stimulation pulses (such as one or more pulse trains) during the on period of stimulation therapy indicated by trace 522.

[0091] Trace 520 indicates the notification rate at which notification packets are sent by an IMD (such as IMD 106). IMD 106 may send notification packets at a first notification rate before time 501. In this example, a notification rate change event may occur before and / or after the start or stop of stimulation therapy. In other words, IMD 106 may determine a predetermined interval or time period before the start and / or stop of therapy delivery in order to adjust or begin adjusting the notification rate at that time. Therefore, the change in notification rate is still based on the therapy schedule. Time 501 corresponds to a notification rate change event before the start of stimulation therapy and the anticipated start of stimulation therapy. Time 502 corresponds to the start of stimulation therapy (e.g., a therapy session). Therefore, IMD 106 detects the notification rate change event as the time before the start of stimulation therapy at time 402 and responds by ramping up the notification rate from the first notification rate to a higher second notification rate. In some examples, the ramp may be a stepped ramp.

[0092] The IMD 106 can continue at a second notification rate until the treatment schedule indicates that stimulation therapy will be turned off or terminated at time 504. In response to the detection of this notification rate change event at time 504, the IMD 106 ramps down the notification rate back to the first notification rate until time 505. In other words, the IMD 106 can gradually reduce the notification rate from the second notification rate to the first notification rate. In some examples, this ramp can be stepped. Figure 5 As shown, the descent rate of the notification rate is slower than the ascent rate. However, in other examples, the ascent rate may be slower than the descent rate, or the ascent and descent rates may be the same. In some examples, the IMD 106 may completely shut down the transmission of notification packets at time 506, which may be a predetermined time after the termination of the stimulation treatment. At time 506, the IMD 106 may reduce the notification rate to zero to conserve power.

[0093] IMD 106 may continue in this very low power mode until another notification rate change event occurs. In some examples, this notification rate change event may be caused by a wake-up signal sent from another device (e.g., external device 104) via a communication protocol different from the communication protocol used for notification grouping. In other examples, the notification rate change event may be an interval preceding the expected start of the next stimulation session according to the treatment schedule. In any case, IMD 106 may change the notification rate back to the first notification rate at time 508 before the next stimulation session at time 510.

[0094] Between times 508 and 510, the user may wish to establish a communication session with IMD 106 to modify one or more parameters defining the next stimulation treatment, delay the next stimulation treatment, or even cancel the next stimulation treatment. If the notification rate is zero before time 410, external device 104 may not be able to communicate any changes to the upcoming stimulation treatment until it begins at time 410. Furthermore, similar to increasing the notification rate at time 501, IMD 106 can identify the notification rate change event at time 509 as the interval before the stimulation treatment resumes at time 510. Therefore, IMD 106 can begin to ramp up the notification rate from the first notification rate at time 509 to a target second notification rate at time 510. IMD 106 can continue to operate in this manner over time to adjust the notification rate based on the treatment schedule. Although in Figure 5 In the example, the change in the notification rate is shown as a ramp change, but in other examples, the IMD 106 can instantly switch between different notification rates to eliminate the ramp (or make the ramp almost instantaneous).

[0095] Figure 6This is a flowchart illustrating example operation of a medical device configured to generate notification groups at different notification rates, according to an example of the technology of this disclosure. It is discussed with respect to IMD 106 and processing circuitry 210 for illustrative purposes only. Figure 6 However, other medical devices can perform similar functions as described in this article.

[0096] exist Figure 6 In the example, processing circuitry 210 can be used to control stimulus generation circuitry 202 to generate and deliver stimulus treatments based on a treatment schedule (600). As described herein, the treatment schedule may include a treatment calendar, treatment cycles, or any other instructions defining when the IMD 106 provides stimulus treatments to the patient during a stimulus session. Processing circuitry 210 is also configured to control telemetry circuitry 208 to send notification packets at a first notification rate (602).

[0097] Processing circuitry 210 may also determine notification rate change events (604) based on the treatment schedule. As described herein, notification rate change events may correspond to the start and / or stop of stimulus delivery, a time occurring at a predetermined interval before (or after) the start of stimulus treatment, a time occurring at a predetermined interval before (or after) the end of stimulus treatment, or any other time at which the system may benefit from a change in notification rate. If no notification rate change event occurs (the "No" branch of block 606), processing circuitry 210 may continue to deliver treatment at the first notification rate and send notification packets (602).

[0098] If processing circuit 210 determines that a notification rate change event already exists (the "Yes" branch of block 606), then processing circuit 210 determines a second notification rate (608) for the identified notification rate change event. In some examples, processing circuit 210 may select different notification rates for different corresponding notification rate change events. Once processing circuit 210 selects a second notification rate, processing circuit 210 continues to control telemetry circuit 208 to send notification packets at the second notification rate (610). Processing circuit 210 then monitors any notification rate change events that would require processing circuit 210 to change the notification rate again as instructed. Figure 6 Continue in the process.

[0099] In some examples, the notification rate change event may not be associated with a treatment schedule. This notification rate change event, which is not determined based on the treatment schedule, can be used alone or in combination with other notification rate change events that may or may not be based on the treatment schedule. In one example, processing circuitry 210 may be configured to “register” with an external device (such as programmer 104) at predetermined times of day, a time schedule, and / or throughout the day. In this way, processing circuitry 210 may be configured to change the notification rate to a faster notification rate in response to these predetermined times in order to communicate with programmer 104 at those predetermined times. Once a connection to programmer 104 is established, processing circuitry 210 can subsequently send and / or receive information from programmer 104. For example, programmer circuitry 210 may send data generated and stored in IMD 106 when IMD 106 is “offline” and not connected to programmer 104. Similarly, IMD 106 may retrieve updates or other information (such as any changes made by the user to the treatment when IMD 106 and programmer 104 are disconnected) from programmer 104 at these predetermined times. In some examples, these predetermined times may be scheduled to occur prior to an arranged virtual or in-person visit with the clinician, so that IMD 106 can quickly send and / or receive data during the clinician's visit.

[0100] The following examples are a non-limiting list of embodiments based on one or more technologies of this disclosure.

[0101] Example 1. An implantable medical device comprising: a telemetry circuit configured to transmit communication notification packets; a treatment circuit configured to deliver treatment according to a treatment schedule; and a processing circuit configured to: control the telemetry circuit to transmit the communication notification packets at a first notification rate; determine a notification rate change event based on the treatment schedule; and, in response to determining the notification rate change event, control the telemetry circuit to transmit the communication notification packets at a second notification rate different from the first notification rate.

[0102] Example 2. The implantable medical device according to Example 1, wherein the communication notification group includes a Bluetooth notification group.

[0103] Example 3. An implantable medical device according to any one of Examples 1 and 2, wherein the treatment schedule includes a treatment calendar that defines the delivery of the treatment at specific times and on specific calendar days of the treatment calendar.

[0104] Example 4. An implantable medical device according to any one of Examples 1 and 2, wherein the treatment schedule includes treatment cycles that define a repeating pattern of treatment delivery and non-delivery of the treatment.

[0105] Example 5. An implantable medical device according to any one of Examples 1 to 4, wherein the notification rate change event is the start of delivery of treatment according to the treatment schedule.

[0106] Example 6. An implantable medical device according to any one of Examples 1 to 4, wherein the notification rate change event is a communication start time, the communication start time being defined as occurring at a predetermined amount of time prior to the commencement of delivery of treatment according to the treatment schedule.

[0107] Example 7. An implantable medical device according to any one of Examples 1 to 6, wherein the second notification rate is higher than the first notification rate, and wherein the processing circuit is configured to: control the telemetry circuit to send the communication notification packets at the second notification rate during at least a portion of the delivery of the treatment; and control the telemetry circuit to send the communication notification packets at the first notification rate during the non-delivery period of the treatment after the delivery of the treatment is terminated.

[0108] Example 8. An implantable medical device according to any one of Examples 1 to 7, wherein the communication notification packet is configured to initiate a communication session via a first communication mode, and wherein the processing circuit is configured to: receive a wake-up signal via a second communication mode during a time period in which the processing circuit controls the telemetry circuit to suppress the transmission of any communication notification packet; and, in response to receiving the wake-up signal, control the telemetry circuit to initiate the transmission of the communication notification packet at the first notification rate.

[0109] Example 9. An implantable medical device according to any one of Examples 1 to 8, wherein the processing circuit is configured to gradually change the first notification rate to the second notification rate over time via a plurality of intermediate notification rates between the first notification rate and the second notification rate.

[0110] Example 10. An implantable medical device according to any one of Examples 1 to 9, wherein the second notification rate is higher than the first notification rate.

[0111] Example 11. An implantable medical device according to any one of Examples 1 to 10, wherein the telemetry circuit is configured to establish a communication session with an external device, the external device being configured to detect the communication notification packets, and wherein the treatment circuit includes a stimulation generation circuit configured to deliver electrical stimulation therapy as the treatment.

[0112] Example 12. A method comprising: controlling a treatment circuit to deliver treatment according to a treatment schedule by a processing circuit; controlling a telemetry circuit to transmit communication notification packets at a first notification rate by the processing circuit; determining a notification rate change event by the processing circuit and based on the treatment schedule; and, in response to determining the notification rate change event, controlling the telemetry circuit to transmit the communication notification packets at a second notification rate different from the first notification rate by the processing circuit.

[0113] Example 13. The method according to Example 12, wherein the communication announcement group includes a Bluetooth announcement group.

[0114] Example 14. The method according to any one of Examples 12 and 13, wherein the treatment schedule includes at least one of the following: a treatment calendar that defines the delivery of the treatment at specific times and calendar days; or a treatment cycle that defines a repeating pattern of delivery and non-delivery of the treatment.

[0115] Example 15. The method according to any one of Examples 12 to 14, wherein the notification rate change event is the start of the delivery of treatment according to the treatment schedule.

[0116] Example 16. The method according to any one of Examples 12 to 14, wherein the notification rate change event is a communication start time, the communication start time being defined as occurring at a predetermined amount of time prior to the commencement of delivery of treatment according to the treatment schedule.

[0117] Example 17. The method according to any one of Examples 12 to 16, wherein the second notification rate is higher than the first notification rate, and wherein: controlling the telemetry circuit to send the communication notification packet includes controlling the telemetry circuit to send the communication notification packet at the second notification rate during at least a portion of the delivery of the treatment; and after the delivery of the treatment is suspended, controlling the telemetry circuit to send the communication notification packet at the first notification rate during the non-delivery period of the treatment.

[0118] Example 18. The method according to any one of Examples 12 to 17, wherein the communication notification packet is configured to initiate a communication session via a first communication mode, and wherein the processing circuit is configured to: receive a wake-up signal via a second communication mode during a time period in which the processing circuit controls the telemetry circuit to suppress the transmission of any communication notification packet; and, in response to receiving the wake-up signal, control the telemetry circuit to initiate the transmission of the communication notification packet at the first notification rate.

[0119] Example 19. The method according to any one of Examples 12 to 18, wherein the telemetry circuit is configured to establish a communication session with an external device, the external device is configured to detect the communication notification packet, and wherein the treatment circuit includes a stimulation generation circuit configured to deliver electrical stimulation therapy as the treatment.

[0120] Example 20. A nontransitory computer-readable storage medium comprising instructions that, when executed by a processing circuit, cause the processing circuit to: control a treatment circuit to deliver treatment according to a treatment schedule; control a telemetry circuit to transmit communication notification packets at a first notification rate; determine a notification rate change event based on the treatment schedule; and, in response to determining the notification rate change event, control the telemetry circuit to transmit the communication notification packets at a second notification rate different from the first notification rate.

[0121] The techniques described in this disclosure can be implemented, at least in part, in hardware, software, firmware, or any combination thereof. For example, aspects of the described techniques can be implemented within one or more processors, 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, and any combination of such components. The terms "processor" or "processing circuitry" can generally refer to any of the aforementioned logic circuitry, alone or in combination with other logic circuitry, or any other equivalent circuitry. A control unit, including hardware, can also perform one or more of the techniques disclosed herein.

[0122] Such hardware, software, and firmware may be implemented within the same device or in separate devices to support the various operations and functions described in this disclosure. Furthermore, any of the described units, modules, or components may be implemented together or separately as discrete but interoperable logical devices. Describing different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be implemented by separate hardware or software components. Rather, the functionality associated with one or more modules or units may be performed by separate hardware or software components or integrated within common or separate hardware or software components.

[0123] The techniques described in this disclosure can also be embedded or encoded in a computer-readable medium (such as a computer-readable storage medium) containing instructions. Instructions embedded or encoded in a computer-readable storage medium can cause a programmable processor or other processor to perform the method, for example, when executing those instructions. 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), electrically erasable programmable read-only memory (EEPROM), flash memory, hard disk, CD-ROM, floppy disk, magnetic tape cassette, magnetic media, optical media, or other computer-readable media.

[0124] Various embodiments have been described. These and other embodiments are within the scope of the appended claims.

Claims

1. An implantable medical device, the implantable medical device comprising: Telemetry circuit, the telemetry circuit being configured to send communication notification packets; A treatment circuit configured to deliver treatment according to a treatment schedule; and Processing circuit, the processing circuit being configured to: The telemetry circuit is controlled to send the communication notification packets at a first notification rate. The notification rate change event is determined based on the treatment plan table; as well as In response to determining the announcement rate change event, the telemetry circuit is controlled to send the communication announcement packet at a second announcement rate different from the first announcement rate.

2. The implantable medical device of claim 1, wherein the communication notification packet includes a Bluetooth notification packet.

3. The implantable medical device according to any one of claims 1 and 2, wherein the treatment schedule includes a treatment calendar that defines the delivery of the treatment at specific times and on specific calendar days of the treatment calendar.

4. The implantable medical device according to any one of claims 1 and 2, wherein the treatment schedule includes treatment cycles that define a repeating pattern of treatment delivery and non-delivery of the treatment.

5. The implantable medical device according to any one of claims 1 to 4, wherein the notification rate change event is the commencement of delivery of treatment according to the treatment schedule.

6. The implantable medical device according to any one of claims 1 to 4, wherein the notification rate change event is a communication start time, the communication start time being defined as occurring at a predetermined amount of time prior to the commencement of delivery of treatment according to the treatment schedule.

7. The implantable medical device according to any one of claims 1 to 6, wherein the second notification rate is higher than the first notification rate, and wherein the processing circuit is configured to: The telemetry circuit is controlled to transmit the communication notification packets at the second notification rate during at least a portion of the delivery of the treatment; and After the delivery of the treatment is suspended, the telemetry circuit is controlled to send the communication notification packets at the first notification rate during the period of non-delivery of the treatment.

8. The implantable medical device according to any one of claims 1 to 7, wherein the communication notification packet is configured to initiate a communication session via a first communication mode, and wherein the processing circuitry is configured to: During the period when the processing circuit controls the telemetry circuit to suppress the transmission of any communication notification packets, a wake-up signal is received via a second communication mode; and In response to receiving the wake-up signal, the telemetry circuit is controlled to initiate the transmission of the communication notification packet at the first notification rate.

9. The implantable medical device according to any one of claims 1 to 8, wherein the processing circuit is configured to gradually change the first notification rate to the second notification rate over time via a plurality of intermediate notification rates between the first notification rate and the second notification rate.

10. The implantable medical device according to any one of claims 1 to 9, wherein the second notification rate is higher than the first notification rate.

11. The implantable medical device according to any one of claims 1 to 10, wherein the telemetry circuit is configured to establish a communication session with an external device, the external device being configured to detect the communication notification packet, and wherein the treatment circuit includes a stimulation generation circuit configured to deliver electrical stimulation therapy as the treatment.

12. The implantable medical device according to any one of claims 1 to 11, wherein the treatment circuit includes a stimulation generating circuit configured to generate electrical stimulation.

13. The implantable medical device according to any one of claims 1 to 12, further comprising one or more pumps configured to deliver a drug, and wherein the treatment circuitry is configured to control the one or more pumps.

14. The implantable medical device according to any one of claims 1 to 12, wherein the treatment circuit is configured to deliver tibial nerve modulation therapy.

15. The implantable medical device according to any one of claims 1 to 14, further comprising a housing configured to surround the telemetry circuit, the treatment circuit, and the processing circuit.

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