Environment awareness of telemetry noise conditions

Abstract

Systems, devices, and techniques describe presenting information regarding noise that may be interfering with communications. For example, a system may include communication circuitry configured to communicate with a first device via a radio frequency (RF) communication format and sense signals indicative of one or more second devices operating via the RF communication format. The system may also include processing circuitry configured to determine, based on the signals, a connection metric representative of communication via the RF communication format and output, for presentation to a user of the system, feedback based on the connection metric.

Description

ENVIRONMENT AWARENESS OF TELEMETRY NOISE CONDITIONS

[0001] This application is a PCT application that claims priority to, and the benefit of, U.S. Provisional Patent Application No. 63 / 676,200, filed July 26, 2024, the entire contents of which is incorporated herein by reference.TECHNICAL FIELD

[0002] This disclosure generally relates to device communication, and, more specifically, managing communication in electronically noisy environments.BACKGROUND

[0003] Medical devices may be external or implanted, and may sense neural signals (e.g., central and peripheral nerves) and / or deliver electrical stimulation therapy to various tissue sites of a patient to treat a variety of symptoms or conditions such as, for example, one or more of 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 stimulation to provide peripheral sensation. A medical device delivers electrical stimulation therapy via one or more leads that include electrodes located proximate to target locations associated with the brain, the spinal cord, pelvic nerves, peripheral nerves, or the gastrointestinal tract of a patient. For bipolar stimulation, the electrodes used for stimulation may be on one or more leads. For unipolar stimulation, the electrodes may include one or more leads and an electrode on a stimulator housing located remotely from the target site (e.g., near clavicle or near buttocks). It may be possible to use leadless stimulation using electrodes mounted on the stimulator housing. Hence, electrical stimulation is used in different therapeutic applications, such as deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic floor stimulation, gastric stimulation, or peripheral nerve field stimulation (PNFS).

[0004] A clinician or patient may select values for a number of programmable parameters, via an external programmer, in order to define the electrical stimulation therapy to be delivered by the implantable stimulator to a patient. For example, the clinician may select one or more electrodes for delivery of the stimulation, a polarity of each selected electrode, a voltage or current pulse amplitude, a pulse width, and a pulse rate as stimulation parameters. A set of parameters, such as a set including electrode combination, electrode polarity, amplitude, pulse width, and pulse rate, may be referred to as a program in the sense that they define the electrical stimulation therapy to be delivered to the patient.SUMMARY

[0005] This disclosure describes example devices, systems, and techniques for monitoring and reducing interference from signal noise on a communication channel between a first device (e.g., medical devices such as implantable medical devices or IMDs) and external devices, such as an external programmer, that is configured to communicate with the first device. In some communication protocols, such as Bluetooth™ communication, the first device and other second devices in the environment around the external device may transmit signals, which may include advertisement packets, that are detectable by the external device for establishing a communication session. The external device may use detected advertisement packets to establish a communication session with the first device.

[0006] In some examples, the first device may have a lower advertisement rate and / or a lower signal strength than the other second devices to decrease energy consumption. This lower advertisement rate and / or signal strength may cause the external device to require more time to detect the advertisement packets or otherwise establish the communication session between the first device and external programmer. The presence of other second devices that also transmit advertising packets may further decrease the ability of the external device to detect the advertisement packets from the first device (which may be implanted within the patient). As described herein, the external device may be configured to identify other second devices that may interfere with establishing the communication session with the first device and perform actions or suggest actions that the user can take to reduce interfering signals from other second devices.

[0007] In some examples, a system includes communication circuitry configured to communicate with a first device via a radio frequency (RF) communication format; and sense signals indicative of one or more second devices operating via the RF communication format; and processing circuitry configured to determine, based on the signals, a connection metric representative of communication via the RF communication format; and output, for presentation to a user of the system, feedback based on the connection metric.

[0008] In some examples, a method includes communicating, by communication circuity, with a first device via a radio frequency (RF) communication format, sensing, by the communication circuity, signals indicative of one or more second devices operating via the RF communication format, determining, by processing circuitry and based on the signals, a connection metric representative of communication via the RF communication format, and outputting, by the processing circuitry and for presentation to a user of a system comprising the communication circuitry, feedback based on the connection metric.

[0009] In some examples, a non-transitory computer-readable storage medium comprising instructions that, when executed, causes the processing circuitry to control communication circuitry to communicate with a first device via a radio frequency (RF) communication format, control the communication circuitry to sense signals indicative of one or more second devices operating via the RF communication format, determine, based on the signals, a connection metric representative of communication via the RF communication format, and output, for presentation to a user of the system, feedback indicative of the connection metric.

[0010] The details of one or more examples of the techniques of this disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques can be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0011] FIG. 1 A is a conceptual diagram illustrating an example system that includes an implantable medical device (IMD) configured to deliver electrical stimulation to a patient according to an example of the techniques of the disclosure.

[0012] FIG. IB is a conceptual diagram illustrating another example system that includes an implantable medical device (IMD) configured to deliver electrical stimulation to a patient according to an example of the techniques of the disclosure.

[0013] FIG. 2 is a block diagram of the example IMD of FIG. 1 for delivering electrical stimulation according to an example of the techniques of the disclosure.

[0014] FIG. 3 is a block diagram of the external device of FIG. 1 for communicating with a medical device according to an example of the techniques of the disclosure.

[0015] FIG. 4 is a flowchart illustrating an example operation of an external device configured to determine a connection metric representative of a radio frequency connection format and provide feedback based on the connection metric.

[0016] FIG. 5 is a flowchart illustrating an example operation of an external device configured to determine a connection metric representative of a radio frequency connection format based on a received signal strength indicator and provide feedback based on the connection metric.

[0017] FIG. 6 is a flowchart illustrating an example operation of an external device configured to determine a connection metric representative of a radio frequency connection format and provide detailed feedback based on the connection metric.

[0018] FIG. 7 is a flowchart illustrating an example operation of an external device configured to determine a connection metric representative of a radio frequency connection format in response to opening an application.

[0019] FIG. 8 is a flowchart illustrating an example operation of an external device configured to determine a connection metric representative of a radio frequency connection format in response to a user request to connect.

[0020] FIG. 9 is a flowchart illustrating an example operation of an external device configured to determine a connection metric representative of a radio frequency connection format in response to a timeout threshold.DETAILED DESCRIPTION

[0021] This disclosure describes example devices, systems, and techniques related to managing communications between a first device (e.g., a medical device or an implantable medical device (IMD)) and external devices (e.g., a patient programmer, a clinician programmer, an application on mobile device) configured to communicate with the first device. The first devices may be configured to provide monitoring and / or therapy 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). The external devices may be able to configure or adjusted parameters that define operation of the first device. In some examples, the parameters of the first device define delivery of electrical stimulation therapy. Electrical stimulation therapy may be delivered via multiple electrodes of one or more leads (e.g., cylindrical or paddle leads) implanted to provide stimulation in the brain, in the spinal cord, in the sacral nerve, or the tibial nerve of a patient. In some examples, electrical stimulation therapy may be delivered via a leadless device. Electrical stimulation therapy may be adaptively adjusted for a patient using at least one program parameter.

[0022] The external device may communicate with the first device (or multiple devices implanted or associated with the patient) via an RF communication format. Bluetooth™ is an example radio frequency communication (RFC) protocol that may be implemented by implantable devices because it enables direct, wireless, arms-length or greater distance connections to other implanted or external devices, which may include mobile phones and tablet computing devices. However, some communication protocols, such as Bluetooth™ communication, require the IMD to transmit advertisement packets so that the IMD is discoverable and connectable by an external device. This transmission of advertisement packetsuses energy and depletes the IMD battery. This energy usage may reduce the battery longevity and / or require more frequent recharging of the battery for rechargeable devices.

[0023] The impact of advertisement packet power usage may be particularly noticeable, or impactful, for relatively low-power stimulation therapies and devices. For example, some therapies, such as sacral and tibial neuromodulation, may only provide infrequent stimulation to maintain efficacious therapy. In this manner, IMD battery drain caused by continuously transmitting advertisement packets could be a significant percentage of the overall battery drain over time when compared to battery drain caused by therapy. The magnitude of average communication protocol (e.g., Bluetooth™) current drain is related to the configured advertisement rate of transmitting Bluetooth™ advertisement packets. Faster advertisement rates (e.g., lower inter-packet time intervals) and / or stronger transmitted signals may enable a faster connection between the IMD and the external device and overall improved user experience.However, faster advertisement rates also requires higher battery current drain and faster depletion of the IMD battery life. Generally, higher advertisement rates also indicates that the inter-packet interval is shorter as well. However, in some examples, the inter-packet interval may not always be indicative of advertisement rate if some advertisement packets include longer transmission times than other advertisement packets. Generally, the advertisement rate for transmission of advertisement packets may be between about 0.0005 Hz and 10 Hz, or between about 0.002 Hz and 5 Hz. Moreover, other wireless devices around the external device may also be transmitting signals, such as advertisement packets, that are detectable by the external device. These other signals and advertisement packets transmitted by other second devices may interfere with the advertisement packets transmitted by the first device (e.g., an IMD) and reduce the ability of the external device to detect the first device advertisement packers and establish a communication session with the first device.

[0024] As described herein, an external device may sense and receive signals (e.g., advertisement packets) of any devices operating in the same radio frequency communication (RFC) format (e.g., Bluetooth™ Low Energy (BLE)) in the vicinity of the external device. The external device may determine a connection metric which represents the ability to connect and / or issues with connecting using the RFC format, such as how busy the RFC format is in the vicinity of the external device or other noise that can be impacting the detection and / or sending of signals between devices. The external device may output an indication of this connection metric in order to provide information to the user regarding possible ways to improve the connection metric and reduce the connection time with the first device. The connection metric may be indicative of the received signal strength from a target device (or a plurality of devices which may include thetarget device) and / or the number of devices transmitting data (e.g., the number of devices utilizing channels of the RFC format for communication).

[0025] Bluetooth™ connections operate in the 2.4 GHz Industrial, Scientific and Medical (ISM) unlicensed band, making them susceptible to environmental radio frequency (RF) noise from various sources, including other devices (e.g., consumer electronics, medical devices, industrial devices) operating in the same frequency band. The environmental RF noise can impact Bluetooth™ connections in several ways. The environmental RF noise can increase discovery and connection (e.g., identifying devices via received advertising packets, establishing a connection, and / or pairing) time due to the system searching through an extensive list of other advertising devices. Further, in order to establish a connection, the devices need to exchange several messages and if any of these messages are disrupted by RF noise, the discovery and connection process can take longer or fail. Additionally, if the RF noise level is high enough, the noise can cause errors in the data being transmitted, requiring a retransmission of the corrupted data reducing overall data throughput.

[0026] These RF noise sources, an external factor outside of the control of the system, can significantly impact the user's experience. The RF noise can create a perception that the system is slow to connect when it is the RF noise that is causing the delay in connection. This can lead to a misperception of the cause of the performance disruptions of the system. Specifically, a user may attribute a slow connection to the system’s performance, not realizing that the actual cause is the RF noise surrounding the user and potentially caused by the user’s other devices. This misperception can lead to a negative user experience (i.e., thinking the system is not fast or efficient) when in fac the system is performing nominally and / or optimally. Additional devices transmitting advertisement packets using Bluetooth™ connections (e.g., BLE) can also impact communications similar to other sources of RF noise. Therefore, the connection metric described herein may be reflective of traffic from other devices using the same Bluetooth™ protocol and / or other RF noise impacting the external device. This RF noise cannot be controlled by the system, e.g., the system cannot prevent or reduce the other systems producing RF noise as it is merely part of the environment in which the system operates. In some examples, a noise metric indicative of the overall RF noise may be generated by the external device in addition to the connection metric which may be more directed to connection channel utilization of the RFC format.

[0027] The external device may output feedback to a user of the external device, where the feedback is based on the connection metric which may correlate to “noise” that can affect the ability of the external device to establish a connection with the first device (e.g., an IMD). For example, the connection metric may be representative of the number of devices transmitting data(e.g., advertisement packets) in the vicinity of the external device and / or the strength at which the other devices are transmitting their advertising packets. As such, the feedback to the user on the current environmental conditions, including the RF noise, may present objective information regarding the connection environment and avoid an erroneous distrust or misperception in the user of the system. Further, providing feedback to the user on the current environmental conditions, including the RF noise, may instill a perception that the device is “smart” and aware of its digital environment. This feedback provided by the external device may also provide recommendations or suggestions on how the user could improve the connection metric and the ability of the external device to communicate with the target first device.

[0028] The external device may start to sense and receive signals via communication circuitry in response to a user opening an application on a programmer. In some examples, the opening of the application can thus trigger processing circuitry to begin sensing and receiving signals from the nearby environment. This process would begin in hopes to detect the target first device, e.g., an IMD of the patient, but other signals may also be detected as part of this process. In some examples, the received signals enable the external device to ascertain the quality of the connection environment and can, based on the quality of the connection environment, generate feedback for presentation to the user before, or in parallel with, attempting a connection with the first device. In some examples, feedback presented to the user before attempting a connection may improve a user experience because the user may be able to take certain actions that may facilitate a faster connection with the first device. The processing circuitry may initiate sensing of signals in response to a user requesting a programmer connect to a first device. In some examples, the requesting of a connection with the target first device can trigger testing the nearby environment for the quality of the connection environment and could, based on the quality of the connection environment, indicate feedback to the user before completing a connection with the first device. In some examples, the external device may sense signals in response to a timeout threshold being met. In some examples, a user may attempt a connection with a first device, and upon a connection failure due to an elapse of too much time or inability to find the device in a digitally crowded or noisy environment, the external device can begin testing the nearby environment for the quality of the connection environment and indicate feedback to the user before attempting a connection with the first device again. Providing feedback to the user on how to improve a connection environment before attempting a re-connection may improve a quality of the user experience because the user may reduce the time needed to connect with the first device any avoid frustration that can result from repeated connection failures due to other RFC traffic.

[0029] The external device may determine the connection metric based on any number of factors of the sensed signals of the RFC format. In some examples, the external device may determine how many other devices, besides a target first device, are transmitting advertising packets. The external device may calculate a received signal strength indicator (RS SI) for each of the devices which are transmitting advertising packets, including the first device and each of the other devices. In some examples, the RSSI is based on the rate of transmission of advertising packets. In some examples, the RSSI based on the attenuation of the sensed signals versus an expected signal strength. The external device may divide the sensed signals into one or more RFC format channels. In some examples, the RSSI may be determined for each of the one or more RFC format channels and the RSSI is based on the rate of transmission of advertising packets on each of the one or more RFC format channels. The RSSI may additionally or alternatively be based on a ratio of a received signal strength from the first device and an expected received signals strength from the first device. In some examples, the RSSI may be based on the number of piconets in the vicinity of the external device.

[0030] The external device may rank each of the devices sensed from the RFC format. In some examples, the ranking is be based on the RSSI of each device. In some examples, the ranking is be based on the RSSI for each of the one or more RFC format channels. In some examples, the ranking is based on how many devices are operating in each of the one or more RFC format channels. The external device may apply a threshold to the ranking of the devices. In some examples, the threshold may apply to each device for which signals are received. In some examples, the threshold may apply to each device for which an RSSI was calculated. In some examples, the threshold may apply to each of the one or more RFC format channels. The threshold may be an absolute value above which the external device’s operations are impacted. The threshold may be a relative value, wherein the threshold may be based on a received value from the first device. In some examples, the threshold applied to other devices may be two orders of magnitude greater than the RSSI of the first device. In some examples, the threshold applied to other devices may be between 1 and 3 orders of magnitude greater than the RSSI of the first device. This threshold may be selected from a range of 10 through 30 dB in some examples.

[0031] The external device may determine that action would be beneficial to the operation of the device or to the user experience of the device and provide feedback to a user based on any one or more of the following: the RSSI of the other devices, the RSSI of each of the one or more RFC format channels, the number of devices transmitting advertising packets, the number of devices in each of the one or more RFC format channels, the number of piconets in the vicinity, and / or the number of devices above the threshold;. The feedback to the user may includeinstructions requesting the user move the system closer to the first device. In some examples, the feedback may include instructions requesting the user move the system closer to the first device may comprise an animation showing where to move the external device with respect to the patient’s body. In some examples, the animation can show what type of device the system is, such as a patient programmer, a clinician programmer, an application on a mobile device, or another communication device. In some examples, the animation can show where on the patient’s body the first device is located. In some examples, the first device is an IMD and can indicate the region where the device is implanted, such as in the pectoral region, the abdomen, the buttock area, near an ankle, or any other region which a medical device may be implanted into. The feedback to the user may additionally or alternatively may include instructions that request the user to generally turn off nearby electronic devices. The feedback to the user may additionally or alternatively may include instructions to the user to turn off specific devices. The specific devices may be devices which were ranked above the threshold. In some examples, the specific devices are devices which frequently transmit advertisement packets. In some examples, the specific devices are devices which transmit advertisement packets across a wide spectrum of RFC format channels. In some examples, the specific devices are the devices which are nearby to the first device. The feedback to the user may specifically identify which devices nearby are the specific devices. In some examples, the feedback may indicate a “Local Name” of the specific device based on the packets set out via the RFC format data including for example the “Local Name” or “Device Name” sent out in a Bluetooth™ data payload. The feedback to the user may additionally or alternatively request that the user move away from other devices which are transmitting over the RFC format. In some examples, the feedback to the user may include an animation presented to the user to move away from other electronic devices. In some examples, the feedback to the user may include a beeping or audio notification to the user to indicate that a movement away from other electronic devices is requested, desired, or suitable. The feedback to the user may include instructions that request the user move inside to protect from RFC format communications or other interference that may be encountered outside. In some examples, inside is inside a house, apartment, office, or other building. The feedback to the user may include instructions that request the user move near a metal wall or metal box.

[0032] The telemetry system of the first device (e.g., neuromodulation telemetry systems) may employ one or more communication protocols, such as Bluetooth™ (ISM bands from 2.402 to 2.48 GHz) or other wireless technology protocols (e.g., RFC protocols) to implement communication with the first device (e.g., programming instruments including proprietary external programmers and commercial off-the-shelf instruments such as cellphones and tablets). Access to external instruments may help to enable recharge and product longevity and may helpto reduce replacement surgeries for IMDs. Impact of high frequency protocols may be high on device longevity and is directly proportional to connection and / or advertising intervals. Faster advertising leads to faster connection and reduced latency, but also higher current drain and reduced device longevity.

[0033] The user experience of connecting a first device (e.g., an implantable medical devices (IMD)) which operates in an RFC format (e.g., Bluetooth™, Bluetooth™ Low Energy (BLE) or another protocol) and has a lower or limited advertisement rate with an external device (e.g., a patient programmer, a clinician programmer, a recharger device (also referred to herein as simply “recharger”), a programming fob, or another device) may benefit from feedback representative of a connection metric based on sensing and analyzing signals from second devices transmitting signals in the vicinity of the external device. The external device may provide feedback to the user attempting to create the connection so that the user may take certain actions or specific steps to improve the connection environment around the external device and the first device. The improvement to the connection environment (e.g., moving away from second devices, turning off second devices, etc.) may enable the external device to establish a connection with a target first device faster and / or with less of a chance of disconnection than would otherwise be possible with the noise from the second devices. As such, the feedback to the user may encourage or request that the user to move the external device and / or first device, turn off other devices in the environment (even identify specific second devices to disable or turn off), or request the user to move away from other devices.

[0034] FIG. 1 A is a conceptual diagram illustrating an example system 100A that includes an implantable medical device (IMD) 106 (an example first device) configured to deliver deep brain stimulation (DBS) to a patient 112. Although the examples described in this disclosure are generally applicable to a variety of electronic communication devices including external devices and IMDs (such as system 100B of FIG. IB), application of such techniques to IMDs and, more particularly, implantable electrical stimulators (e.g., neurostimulators) can be described for purposes of illustration. More particularly, the disclosure can refer to an implantable DBS system for purposes of illustration, but without limitation as to other types of electronic communication devices, IMDs 106, or other BLE applications. System 100A may be configured to deliver one or more of deep brain stimulation (DBS), spinal cord stimulation (SCS), sacral nerve stimulation (SNS) such as in FIG. IB, tibial nerve stimulation (TNS), targeted drug delivery (TDD), pelvic stimulation, gastric stimulation, or peripheral nerve field stimulation (PNFS), or any other stimulation therapy capable of treating a condition of patient 122.Although external device 104 is described as directly communicating with IMD 106, such as via an RFC format that could be BLE, external device 104 may communicate directly with anintermediate external device via the RFC format and then the intermediate external device can relay that information from external device 104 to IMD 106 via a different RFC format or other communication protocol (e.g., inductive coupling).

[0035] DBS, or other therapies such as SNS or TNS, may operate open loop or, alternatively, adaptive format in the sense that IMD 106 may adjust, increase, or decrease the magnitude of one or more parameters of the DBS in response to changes in patient activity or movement, a severity of one or more symptoms of a disease of the patient, a presence of one or more side effects due to the DBS, or one or more sensed signals of the patient. One example of system 100 is a bidirectional DBS system with capabilities to both deliver stimulation and sense intrinsic neuronal signals. System 100A may provide for “closed-loop” therapy where IMD 106 may continuously monitor the state of certain biomarker signals and deliver stimulation according to preprogrammed routines based on the biomarker signals.

[0036] System 100 A may be configured to treat a patient condition, such as a movement disorder, neurodegenerative impairment, a mood disorder, or a seizure disorder of patient 112. Patient 112 ordinarily is a human patient. In some cases, however, therapy system 100A may be applied to other mammalian or non-mammalian, non-human patients. While movement disorders and neurodegenerative impairment are primarily referred to herein, in other examples, therapy system 100 A may provide therapy to manage symptoms of other patient conditions, such as, but not limited to, seizure disorders (e.g., epilepsy) or mood (or psychological) disorders (e.g., major depressive disorder (MDD), bipolar disorder, anxiety disorders, post-traumatic stress disorder, dysthymic disorder, and obsessive-compulsive disorder (OCD)) as well as, for example, neural control of prosthetic devices or stimulation to provide sensory feedback to the patients. At least some of these disorders may be manifested in one or more patient movement behaviors. A movement disorder or other neurodegenerative impairment may include symptoms such as, for example, muscle control impairment, motion impairment, or other movement problems, such as rigidity, spasticity, bradykinesia, rhythmic hyperkinesia, nonrhythmic hyperkinesia, and akinesia. In some cases, the movement disorder may be a symptom of Parkinson’s disease. However, the movement disorder may be attributable to other patient conditions.

[0037] Example therapy system 100 A includes external device 104, IMD 106, lead extension 110, one or more leads 114A and 114B with respective sets of one or more electrodes 116, 118. In the example shown in FIG. 1, electrodes 116, 118 of leads 114 A, 114B are positioned to deliver electrical stimulation to a tissue site within brain 120, such as a deep brain site under the dura mater of brain 120 of patient 112. In some examples, delivery of stimulation to one or more regions of brain 120, such as the subthalamic nucleus, globus pallidus or thalamus, may be an effective treatment to manage movement disorders, such as Parkinson’s disease. Some or all ofelectrodes 116, 118 also may be positioned to sense neurological brain signals within brain 120 of patient 112. In some examples, some of electrodes 116, 118 may be configured to sense neurological brain signals and others of electrodes 116, 118 may be configured to deliver adaptive electrical stimulation to brain 120. In other examples, all of electrodes 116, 118 are configured to both sense neurological brain signals and deliver adaptive electrical stimulation to brain 120. In some examples, unipolar stimulation may be possible where one electrode is on the housing of IMD 106.

[0038] IMD 106 includes a therapy module (e.g., processing circuitry, signal generation circuitry or other electrical circuitry configured to perform the functions attributed to IMD 106) that 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 that are configured 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 stimulation electrode combination. The stimulation electrode combination may be selected for a particular patient 112 and target tissue site (e.g., selected based on the patient condition). The group of electrodes 116, 118 includes at least one electrode and may include a plurality of electrodes. In some examples, the plurality of electrodes 116 and / or 118 may have a complex electrode geometry such that two or more electrodes are located at different positions around the perimeter of the respective lead.

[0039] In some examples, neurological signals sensed within brain 120 may reflect changes in electrical current produced by the sum of electrical potential differences across brain tissue. Examples of neurological brain signals include, but are not limited to, bioelectric signals generated from local field potentials (LFP) sensed within one or more regions of brain 120. Electroencephalogram (EEG) signal or an electrocorti cogram (ECoG) signal are also examples of bioelectric signals. For example, neurons generate the bioelectric signals, and if measured at depth, it is LFP, if measured on the cerebral cortex, it is ECoG, and if on scalp, it is EEG. In other examples, IMD 106 may sense evoked signals, such as evoked compound action potentials (ECAPs), evoked resonant neural activity (ERNA), etc.

[0040] Electrical stimulation generated by IMD 106 may be configured to manage a variety of disorders and conditions. In some examples, the stimulation generator of IMD 106 is configured to generate and deliver electrical stimulation pulses to patient 112 via electrodes of a selected stimulation electrode combination. However, in other examples, the stimulation generator of IMD 106 may be configured to generate and deliver a continuous wave signal, e.g., a sine wave or triangle wave. In either case, a stimulation generator within IMD 106 may generate the electrical stimulation therapy for DBS according to a selected therapy program. Inexamples in which IMD 106 delivers electrical stimulation in the form of stimulation pulses, a therapy program may include a set of therapy parameter values (e.g., stimulation parameters), such as a stimulation electrode combination for delivering stimulation to patient 112, pulse frequency, pulse width, and a current or voltage amplitude of the pulses. As previously indicated, the electrode combination may indicate the specific electrodes 116, 118 that are selected to deliver stimulation signals to tissue of patient 112 and the respective polarities of the selected electrodes. The electrical stimulation generated by IMD 106 may generate, for example, burst pulses, interleaved pulses, or concurrent pulses.

[0041] In some examples, electrodes 116, 118 may be radially-segmented DBS arrays (rDBSA) of electrodes. Radially-segmented DBS arrays refer to electrodes that are segmented radially along the lead. As one example, leads 114A and 114B may include a first set of electrodes arranged circumferentially around leads 114A and 114B that are all at the same height level on leads 114A and 114B. Each of the electrodes in the first set of electrodes is a separate segmented electrode and form a level of radially-segmented array of electrodes. Leads 114A and 114B may include a second set of electrodes arranged circumferentially around leads 114A and 114B that are all at the same height level on leads 114A and 114B. Each of the electrodes in the first set of electrodes is a separate segmented electrode and form a level of radially-segmented array of electrodes. The rDBSA electrodes may be beneficial for directional stimulation and sensing.

[0042] IMD 106 may be implanted within a subcutaneous pocket above the clavicle, on or within cranium 122, or at any other suitable site within patient 112. Generally, IMD 106 is constructed of a biocompatible material that resists corrosion and degradation from bodily fluids. IMD 106 may comprise a hermetic housing.

[0043] As shown in FIG. 1 A, implanted lead extension 110 is coupled to IMD 106 via connector 108 (also referred to as a connector block or a header of IMD 106). In the example of FIG. 1 A, lead extension 110 traverses from the implant site of IMD 106 and along the neck of patient 112 to cranium 122 of patient 112 to access brain 120. In the example shown in FIG. 1 A, leads 114A and 114B (collectively “leads 114”) are implanted within the right and left hemispheres (or in just one hemisphere in some examples), respectively, of patient 112 in order to deliver electrical stimulation to one or more regions of brain 120, which may be selected based on the patient condition or disorder controlled by therapy system 100A. The specific target tissue site and the stimulation electrodes configured to deliver stimulation to the target tissue site, however, may be selected, e.g., according to the identified patient behaviors and / or other sensed patient parameters. For example, the target tissue site may be the location of the oscillatory signal source that generates the bioelectric signal including a signal component in the betafrequency band. The stimulation electrodes configured to deliver stimulation to the target tissue site may be those that are most proximal to the oscillatory signal source, e.g., using the example techniques described in this disclosure. Other lead 114, lead extension 110, and IMD 106 implant sites are contemplated depending on clinical application or target tissue / nerve. For example, IMD 106 may be implanted on or within cranium 122, in some examples. Leads 114A and 114B may be implanted within the same hemisphere or IMD 106 may be coupled to a single lead implanted in a single hemisphere, in some examples.

[0044] Existing lead sets include axial leads carrying ring electrodes disposed at different axial positions and so-called "paddle" leads carrying planar arrays of electrodes. Selection of electrode combinations within an axial lead, a paddle lead, or among two or more different leads by a clinician may enable the clinician to modulate the delivered therapy. In some examples, more complex lead array geometries may be used as suitable. Pelvic stimulation may use cuff electrodes wrapped around the sacral (or other pelvic) nerve.

[0045] Although leads 114 are shown in FIG. 1 A as being coupled to a common lead extension 110, in other examples, leads 114 may be coupled to IMD 106 via separate lead extensions or directly to connector 108. Leads 114 may be positioned to deliver electrical stimulation to one or more target tissue sites within brain 120 to manage patient symptoms associated with a movement disorder of patient 112. Leads 114 may be implanted to position electrodes 116, 118 at suitable locations of brain 120 through respective holes in cranium 122. Leads 114 may be placed at any location within brain 120 such that electrodes 116, 118 are capable of providing electrical stimulation to target tissue sites within brain 120 during treatment. For example, electrodes 116, 118 may be surgically implanted under the dura mater of brain 120 or within the cerebral cortex of brain 120 via a burr hole in cranium 122 of patient 112, and electrically coupled to IMD 106 via one or more leads 114.

[0046] In the example shown in FIG. 1 A, electrodes 116, 118 of leads 114 are shown as ring electrodes. Ring electrodes may be used in DBS applications because ring electrodes are relatively simple to program and are capable of delivering an electrical field to any tissue adjacent to electrodes 116, 118. In other examples, electrodes 116, 118 may have different configurations. For example, at least some of the electrodes 116, 118 of leads 114 may have a complex electrode array geometry that is capable of producing shaped electrical fields. The complex electrode array geometry may include multiple electrodes (e.g., partial ring or segmented electrodes) around the outer perimeter of each lead 114, rather than one ring electrode. In this manner, electrical stimulation may be directed in a specific direction from leads 114 to enhance therapy efficacy and reduce possible adverse side effects from stimulating a large volume of tissue.

[0047] In some examples, a housing of IMD 106 may include one or more stimulation and / or sensing electrodes. In some examples, leads 114 may have shapes other than elongated cylinders as shown in FIG. 1 A. For example, leads 114 may be paddle leads, spherical leads, bendable leads, or any other type of lead or shape of lead effective in treating patient 112, minimizing invasiveness of leads 114, and / or as suitably selected by a clinician.

[0048] IMD 106 includes a memory to store a plurality of therapy programs that each define a set of therapy parameter values. In some examples, IMD 106 may select a therapy program from the memory based on various parameters, such as sensed patient parameters and the identified patient behaviors. IMD 106 may generate electrical stimulation based on the parameters of the selected therapy program to manage the patient symptoms associated with a movement disorder.

[0049] External device 104 wirelessly communicates with IMD 106 as needed to provide or retrieve therapy information. External device 104 is an external computing device that the user, e.g., a clinician and / or patient 112, may use to communicate with IMD 106. For example, external device 104 may be a clinician programmer that the clinician uses to communicate with IMD 106 and program one or more therapy programs for IMD 106. External device 104 may be a patient programmer that enables patient 112 to select programs and / or view and modify therapy parameters. The clinician programmer may include more programming features than the patient programmer. In other words, more complex or sensitive tasks may only be enabled by the clinician programmer to deny an untrained patient from making undesirable changes to IMD 106. External device 104 may be any type of computing device, such as a proprietary device, a cellular phone, a smartphone, a tablet computing device, a laptop, or any other type of computing device. Generally, external device 104 includes a user interface that may provide and / or receive information from a user. In some examples, external device 104 may be configured to pass information between IMD 106 and a different external device 104, but external device 104 may or may not have a user interface for programming. Instead, external device 104 may receive programming commands from the different external device 104 (e.g., a server or other computing device that includes a user interface) and transmit those programming commands to IMD 106 and / or receive information from IMD 106 and send that information to the different external device.

[0050] When external device 104 is configured for use by the clinician, external device 104 may be configured to transmit initial programming information to IMD 106. This initial information may include hardware information, such as the type of leads 114 and the electrode arrangement, the position of leads 114 within brain 120, the configuration of electrode array 116, 118, initial programs defining therapy parameter values, and any other information the cliniciandesires to program into IMD 106. External device 104 may also be capable of completing functional tests (e.g., measuring the impedance of electrodes 116, 118 of leads 114).

[0051] The clinician may also store therapy programs within IMD 106 with the aid of external device 104. During a programming session, the clinician may determine one or more therapy programs that may provide efficacious therapy to patient 112 to address symptoms associated with the patient condition, and, in some cases, specific to one or more different patient states, such as a sleep state, movement state, or rest state. For example, the clinician may select one or more stimulation electrode combinations with which stimulation is delivered to brain 120. During the programming session, the clinician may evaluate the efficacy of the specific program being evaluated based on feedback provided by patient 112 or based on one or more physiological parameters of patient 112 (e.g., muscle activity, muscle tone, rigidity, tremor, etc.). Identified patient behavior from video information may be used as feedback during the initial and subsequent programming sessions. External device 104 may assist the clinician in the creation / identification of therapy programs by providing a methodical system for identifying potentially beneficial therapy parameter values.

[0052] However, in some examples, IMD 106 or external device 104 (e.g., a clinician programmer, a patient programmer, a recharger, a programmer fob, etc.), alone or in combination, may automatically determine electrode configuration and therapy parameters. For example, IMD 106 may determine which electrodes to use for stimulation based on which electrodes are most proximal to target tissue. In some examples, external device 104 may output information indicating the selected electrode configuration for stimulation and the determined stimulation amplitude or other therapy parameter for the clinician or physician to review and confirm before IMD 106 delivers therapy via the selected electrode configuration with the determined stimulation amplitude.

[0053] External device 104 may 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) in order to deny patient 112 from altering critical functions of IMD 106 or applications that may be detrimental to patient 112. In this manner, external device 104 may only enable patient 112 to adjust values for certain therapy parameters or set an available range of values for a particular therapy parameter. For example, external device 104 may only enable patient 112 to adjust an amplitude or an intensity (by combination or amplitude, pulse width and / or pulse rate).

[0054] External device 104 may also provide an indication to patient 112 when therapy is being delivered, when patient input has triggered a change in therapy, when the power source within external device 104 or IMD 106 needs to be replaced or recharged, when patient 112 isrequested to move external device 104 closer to IMD 106, when patient 112 is requested to move to a different area, when patient 112 is requested to turn off one or more second devices, when patient 112 is requested to move to a different area, or any other suitable notification to alter functioning or functionality of external device 104 and IMD 106. For example, external device 104 may include an alert LED and / or a touchscreen, may flash a message to patient 112 via a programmer display, generate an audible sound or somatosensory cue to confirm patient input was received, e.g., to indicate a patient state or to manually modify a therapy parameter.External device 104 may additionally or alternatively include a user interface which may comprise a screen.

[0055] Therapy system 100 A may be implemented to provide chronic stimulation therapy to patient 112 over the course of several months or years. However, system 100A may also be employed on a trial basis to evaluate therapy before committing to full implantation. If implemented temporarily, portions of system 100A may not be implanted within patient 112. For example, patient 112 may be fitted with an external medical device, such as a trial stimulator, rather than IMD 106. The external medical device may be coupled to percutaneous leads or to implanted leads via a percutaneous extension. If the trial stimulator indicates DBS system 100 A provides effective treatment to patient 112, the clinician may implant a chronic stimulator within patient 112 for relatively long-term treatment.

[0056] In some examples, IMD 106 may be configured to provide electrical stimulation for treatment of a patient condition supplemental to medication provided to patient 122. Although some examples are described with the use of IMD 106 that provides stimulation, the techniques are not limited, and the techniques may apply to examples where no stimulation is provided. For example, IMD 106 may temporarily not provide stimulation and treatment of a patient condition of patient 122 if patient 112 is treated by medication or with other techniques. 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 disease like Parkinson’s disease and dystonia and leads 114 are in locations to treat both Parkinson’s disease and dystonia. A single IMD 106 may listen / monitor to different LFP bands to look at various medication or disease states via the same lead / same hemisphere or different hemispheres.

[0057] According to the techniques of the disclosure, external device 104 (e.g., a clinician programmer, a patient programmer, a recharger, an intermediate external device, a programmer fob, etc.) may be configured to sense and receive signals (e.g., advertisement packets) transmitted by IMD 106 for the purposes of establishing a communication session with IMD 106. External device 104 and IMD 106 may use a common RFC format for exchanging information wireless, such as a Bluetooth™ Low Energy (BLE) format. However, other second devices that are notpart of system 100A may also operate with a similar RFC format and also in the vicinity of external device 104 such that external device 104 detects these second device signals (e.g., advertising packets in the example of BLE) as well. External device 104 may be configured to determine a connection metric which represents various characteristics of the RFC format environment that external device 104 is operating, such as how busy the RFC format is (e.g., the number of second devices transmitting signals) in the vicinity of external device 104. External device 104 may be configured to output feedback to a user of external device 104 based on the connection metric which may be indicative of the number of devices in the vicinity of external device 104 and / or the strength at which the other devices are transmitting their advertising packets. Techniques described herein may improve patient experience by identifying actions that a user and / or system can take for improving a connection speed between IMD 106 and external device 104, reducing connectivity loss between IMD 106 and external device 104, and / or providing feedback on the connection between IMD 106 and external device 104.

[0058] An example IMD 106 may include telemetry circuitry configured to transmit communication advertisement packets, and stimulation generation circuitry configured to deliver electrical stimulation therapy according to a therapy schedule. In some examples, the communication advertisement packets may be or include Bluetooth™ advertisement packets.

[0059] The therapy schedule may refer to the instructions that define when IMD 106 is to deliver therapy according to one or more therapy programs. A therapy program may define a set of stimulation parameters that define the electrical stimulation delivered, such as electrode combination, current or voltage amplitude, pulse width, pulse frequency, duty cycle, burst frequency, burst duration, pulse shape, etc. Therefore, IMD 106 may deliver stimulation therapy defined by the one or more therapy programs during a therapy session. The therapy schedule may define when IMD 106 is to begin and / or end a therapy session. In some examples, the therapy schedule may be or may include a therapy calendar defining delivery of the electrical stimulation therapy at specific calendar days of the therapy calendar. For example, a therapy calendar may specify that IMD 106 should execute a therapy session every Tuesday and Friday of each week, or during specific calendar days of a month, and at particular times of those specified days. In other examples, the therapy schedule includes a therapy cycle defining a repeating pattern of delivery of the electrical stimulation therapy and non-delivery of the electrical stimulation therapy. For example, the therapy cycle may specify that a therapy session is to be repeated every predetermined number of hours or initiated again after a predetermined interval from the end of the last therapy session. In some examples, the therapy schedule may include a combination of the therapy calendar and therapy cycle. In other examples, the therapyschedule may include or be augmented by sensed patient parameters that trigger the delivery, or termination of, stimulation therapy.

[0060] In some examples, IMD 106 may enter a sleep mode in which the telemetry circuitry and / or processing circuitry enter a low power mode and advertisement packets are no longer transmitted (or transmitted at very long intervals such as on the order of many minutes or hours). IMD 106 may monitor an internal timer and exit the sleep mode to begin transmitting advertisement packets again once the sleep mode has been exited. In other examples, IMD 106 may require a stimulus from another device. For example, IMD 106 may receive a wake-up signal via a second communication modality (different than the advertisement packet communication modality) during a period of time that IMD 106 controlled the telemetry circuitry to withhold transmission of any communication advertisement packets. In other examples, the wake-up signal may be generated by a different sensor or element of IMD 106 in response to a respective sensed change. For example, a magnetic field detector (e.g., a hall sensor) may detect an external magnet that a user places near IMD 106 and IMD 106 may wake-up in response to receiving that signal generated by the magnetic field detector. Other sensors signals that IMD 106 may monitor to wake-up communications may include an output from an accelerometer, an output from a sound sensor, or an output from a temperature sensor. Responsive to receiving the wake-up signal, IMD 106 may control the telemetry circuitry to initiate the transmission of the communication advertisement packets.

[0061] FIG. IB is a conceptual diagram illustrating another example system 100B that includes an implantable medical device (IMD) 130 configured to deliver electrical stimulation to a patient according to an example of the techniques of the disclosure. In the example of FIG. IB, system 100B may be similar to system 100 A and includes IMD 130 which may be similar to IMD 106 with external device 104. IMD 130 may be configured to deliver therapy to and / or sense physiological signals from target tissue. The target tissue may include or be near spinal cord 128 and / or pelvic nerves 136 (e.g., a pudendal nerve or sacral nerve), or any other nervous or muscle tissue that may be stimulated or from which physiological signals may be sensed of patient 112 through lead 134 (coupled to IMD 130 via connector 132). Lead 134 may carry a plurality of electrodes 138 at the distal end of lead 134. IMD 130 may provide neurostimulation to treat symptoms of patient 112, such as pain, fecal or urinary incontinence, erectile dysfunction, or other sexual dysfunction. IMD 130 may thus be configured to provide sacral nerve stimulation in one example.

[0062] In other examples, IMD 130 may be configured to deliver electrical stimulation to other nerves that may alleviate symptoms related to pelvic floor disorders. In one example, IMD 130 may be configured to deliver electrical stimulation to the tibial nerve (e.g., tibial nervestimulation). Electrodes 138 may be implanted near a suitable portion of the tibial nerve (e.g., a leg and / or ankle of patient 112). In some examples, IMD 130 may be implanted for tibial stimulation or a housing of IMD 130 is external to the patient and one or more electrodes may be external and / or implanted via percutaneous lead.

[0063] FIG. 2 is a block diagram of the example IMD of FIG. 1 for delivering electrical stimulation according to an example of the techniques of the disclosure. In the example shown in FIG. 2, IMD 106 includes processing circuitry 210, memory 212, stimulation generation circuitry 202, sensing circuitry 204, telemetry circuitry 208, and power source 220. Each of these circuits may be electrical circuitry configured to perform the functions attributed to each respective circuit. Memory 212 may include any volatile or non-volatile media, such as a random-access memory (RAM), read only memory (ROM), non-volatile RAM (NVRAM), ferroelectric RAM (FRAM), electrically erasable programmable ROM (EEPROM), flash memory, and the like. Memory 212 may store computer-readable instructions that, when executed by processing circuitry 210, cause IMD 106 to perform various functions. Memory 212 may be a storage device or other non-transitory medium.

[0064] In the example shown in FIG. 2, memory 212 stores electrical stimulation information 214. Electrical stimulation information 214 may include program parameters (e.g., a therapy parameter set), such as a stimulation electrode combination, electrode polarity, current or voltage amplitude, pulse width, and pulse rate. In some examples, individual therapy programs may be stored as a therapy group, which defines a set of therapy programs with which stimulation may be generated during a therapy session in which stimulation therapy is delivered. The stimulation signals defined by the therapy programs of the therapy group may be delivered together on an overlapping or non-overlapping (e.g., time-interleaved) basis.

[0065] Accordingly, in some examples, stimulation generation circuitry 202 may generate electrical stimulation signals in accordance with the electrical stimulation parameters noted above, which may be examples of program parameters. Other ranges of therapy parameter values may also be useful and may depend on the target stimulation site within patient 112. While stimulation pulses are described, stimulation signals may be of any form, such as continuous-time signals (e.g., sine waves) or the like. Stimulation generation circuitry 202 is an example of therapy circuitry configured to deliver a therapy from IMD 106. In other examples, therapy circuitry may include circuitry configured to control and / or deliver other therapies, such as a fluid that contains one or more drugs (e.g., insulin, pain relievers, behavioral drugs, etc.). In this manner, the therapy circuitry may control one or more pumps to deliver the drug from IMD 106. Other types of therapies may additionally, or alternatively, be delivered using therapy circuitry and IMD 106.

[0066] Processing circuitry 210 may include fixed function processing circuitry and / or programmable processing circuitry, and may comprise, for example, any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), discrete logic circuitry, or any other processing circuitry configured to provide the functions attributed to processing circuitry 210 herein may be embodied as firmware, hardware, software or any combination thereof. Processing circuitry 210 may control stimulation generation circuitry 202 according to therapy programs 214 stored in memory 212 to apply particular stimulation parameter values specified by one or more of programs, such as voltage amplitude or current amplitude, pulse width, and / or pulse rate.

[0067] In the example shown in FIG. 2, 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 may control individual voltage or current sources and sinks coupled to respective electrodes 116, 118, functioning as cathodes or anodes, to deliver stimulation signals to patient tissue. In other examples, processing circuitry may control switch circuitry to apply the stimulation signals generated by stimulation generation circuitry 202 to selected combinations of electrodes 116, 118.

[0068] Stimulation generation circuitry 202 may be a single channel or multi-channel stimulation generator. Stimulation generation circuitry 202 may 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. For example, as mentioned above, stimulation generation circuitry 202 may comprise multiple voltage or current sources and sinks that are coupled to respective electrodes to drive the electrodes as cathodes or anodes simultaneously or at different times. In this example, IMD 106 may not require the functionality of switch circuitry for time-interleaved multiplexing of stimulation via different electrodes. In other examples, however, stimulation generation circuitry 202 may be configured to deliver multiple channels on a time-interleaved basis. In some examples, switch circuitry may time divide the output of stimulation generation circuitry 202 across different electrode combinations at different times to deliver multiple programs or channels of stimulation energy to patient 112.

[0069] Telemetry circuitry 208 supports wireless communication using one or more RF and / or inductive communication protocols (e.g., Radio Frequency Communication Protocols, Bluetooth™, Wi-Fi™, Near-Field Communication (NFC), Near Field Magnetic Induction (NFMI), Long Term Evolution, 5th generation (LTE / 5G), or MedRadio (MICS: Medical Implant Communication Service, MEDS: Medical External Device Service, MB AD: Medical Body AreaNetwork)) between IMD 106 and an external device 104 or another computing device under the control of processing circuitry 210. In some examples, telemetry circuitry 208 supports a telemetry frequency that may correspond to a high frequency or radio frequency, which may be a radio frequency established via Bluetooth™, Wi-Fi™, Near-Field Communication (NFC), 175KHz inductive telemetry, or MICS, for example. Telemetry circuitry 208 may be configured to receive an inductive sting. Processing circuitry 210 of IMD 106 may receive, as updates to programs (e.g., at least one program parameter), values for various stimulation parameters such as magnitude and electrode combination, from external device 104 via telemetry circuitry 208. The updates to the therapy programs may be stored within therapy programs 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, may accomplish communication by radiofrequency (RF) communication techniques (e.g., Bluetooth™, Wi-Fi, Near-Field Communication (NFC), or MICS). In addition, telemetry circuitry 208 may communicate with external device 104 via proximal inductive interaction of IMD 106 with external device 104. Accordingly, telemetry circuitry 208 may send information to external device 104 on a continuous basis, at periodic intervals, or upon request from IMD 106 or external device 104.

[0070] Telemetry circuitry 208 may periodically output an advertisement packet for a connection at an advertising interval, where the advertising interval may be within a range (e.g., less than 100 milliseconds (ms), 100 ms to 500 ms, 1 second, more than 1 second, etc.) or other advertisement rate as described herein. The advertisement packet may include information on how to connect with the advertising device, such as, for example, one or more of: (1) media access control (MAC) addresses for IMD 106 and external device 104; (2) a real time-point in time for the transfer to start; (3) an indication of a starting frequency; (4) an indication of a hop set; (5) a connection interval; or (6) a connection latency. In some examples, telemetry circuitry 208 may receive the advertisement packet and connect with another device (e.g., external device 104) using the received advertisement (e.g., using a starting frequency and hop set of the received advertisement packet). Telemetry instructions 216 may store the instructions related to the advertisement packets of IMD 106, such as the advertisement rate, paired devices, permitted devices, or any other instructions that IMD 106 would utilize in order to achieve the functionality described herein. Processing circuitry 210 may control telemetry circuitry 208 to change the advertising interval (or rate) for different situations per telemetry instructions 216 or other instructions.

[0071] Power source 220 may deliver operating power to IMD 106. Power source 220 may include a small rechargeable or non-rechargeable battery and a power generation circuit to produce the operating power. Recharging may be accomplished through proximal inductiveinteraction between an external charger and an inductive charging coil within IMD 106. In some examples, power requirements may be small enough to enable IMD 106 to utilize patient motion and implement a kinetic energy-scavenging device to trickle charge a rechargeable battery. In other examples, traditional batteries may be used for a limited period of time.

[0072] Processing circuitry 210 of IMD 106 may sense, via electrodes 116, 118 interposed along leads 114 (and sensing circuitry 204), one or more bioelectric signals of brain 120 of patient 112. Processing circuitry 210 of IMD 106 may deliver, via electrodes 116, 118 (and stimulation generation circuitry 202), electrical stimulation therapy to patient 112 based on the sensed one or more bioelectric signals of brain 120. The adaptive DBS therapy is defined by electrical stimulation information 214. For example, electrical stimulation information 214 may include a current amplitude (for a current-controlled system) or a voltage amplitude (for a voltage-controlled system), a pulse rate or frequency, and a pulse width, or a number of pulses per cycle. In examples where the electrical stimulation is delivered according to a “burst” of pulses, or a series of electrical pulses defined by an “on-time” and an “off-time,” the one or more parameters may define one or more of pulses per burst, an on-time, and an off-time. Processing circuitry 210, via electrodes 116, 118, delivers to patient 112 adaptive DBS and may adjust one or more parameters defining the electrical stimulation based on corresponding parameters of the sensed one or more bioelectric signals of brain 120.

[0073] Telemetry circuitry 208 may be configured to output an advertisement packet, such as, an advertisement for a wireless communication session or advertisement compliant with another protocol. For example, telemetry circuitry 208 may output the advertisement packet at an advertisement rate (or advertising interval). The advertisement rate may include a Bluetooth™ Low Energy advertisement rate. Telemetry circuitry 208 may ping external device 104. For example, telemetry circuitry 208 may output an advertisement or advertisement packet that external device 104 or another device listens for. In some examples, the telemetry circuitry 208 may output the advertisement packet in response to a sting and / or may periodically output the advertisement using an advertisement rate (e.g., with a random delay). As the advertisements take energy, telemetry circuitry 208 may benefit from sending advertisements in lower advertisement rates or longer intervals. The advertisement may comprise security information for a communication session and / or connection information for the communication session.

[0074] FIG. 3 is a block diagram of the external device 104 of FIG. 1. Although external device 104 may generally be described as a hand-held device, external device 104 may be a larger portable device or a more stationary device. In addition, in other examples, external device 104 may be included as part of an external charging device or include the functionality of an external charging device. In some examples, where external device 104 is the more stationarydevice, a portion of the more stationary device may have a wand containing the telemetry circuitry which may be moved by a user. As illustrated in FIG. 3, external device 104 may include processing circuitry 310, memory 312, user interface 302, telemetry circuitry 308, and power source 320. Memory 312 may store instructions, including at least advertisement analysis instructions 316, that, when executed by processing circuitry 310, cause processing circuitry 310 and external device 104 to provide the functionality ascribed to external device 104 throughout this disclosure. Each of these components, or modules, may include electrical circuitry that is 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 with respect to processing circuitry 310.

[0075] In general, external device 104 comprises any suitable arrangement of hardware, alone or in combination with software and / or firmware, to perform the techniques attributed to external device 104, and processing circuitry 310, user interface 302, and telemetry circuitry 208 of IMD 106. In various examples, external device 104 may include one or more processors, which may include fixed function processing circuitry and / or programmable processing circuitry, as formed by, for example, one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry, as well as any combinations thereof. External device 104 also, in various examples, may include memory 312, such as RAM, ROM, PROM, EPROM, EEPROM, flash memory, a hard disk, a CD-ROM, comprising executable instructions for causing the one or more processors to perform the actions attributed to them. Moreover, although processing circuitry 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 one another. In some examples, processing circuitry 310 and telemetry circuitry 308 correspond to individual hardware units, such as ASICs, DSPs, FPGAs, or other hardware units. While telemetry circuitry 308 is described as being arranged within external device 104, in some examples, aspects of telemetry circuitry 308 (e.g., configuring IMD 106 to advertise at an advertising interval or initiating a communication session) may be performed by telemetry circuitry 308 external to external device 104 (e.g., in an intermediate device).

[0076] Memory 312 (e.g., a storage device) may store instructions that, when executed by processing circuitry 310, cause processing circuitry 310 and external device 104 to provide the functionality ascribed to external device 104 throughout this disclosure. For example, memory 312 may include instructions that cause processing circuitry 310 to obtain a parameter set from memory or receive a user input and send a corresponding command to IMD 106, or instructions for any other functionality. In addition, memory 312 may include a plurality of programs, where each program includes a parameter set that defines stimulation therapy. Memory 312 mayadditionally or alternatively include advertisement analysis instructions 316 which may enable external device 104 to analyze the surrounding RFC environment as described throughout this disclosure.

[0077] User interface 302 may include a button or keypad, lights, a speaker and / or microphone for voice commands, a display, such as a liquid crystal (LCD), light-emitting diode (LED), or organic light-emitting diode (OLED). In some examples the display may be a touch screen. User interface 302 may be configured to display any information related to the delivery of stimulation therapy, identified patient behaviors, sensed patient parameter values, patient behavior criteria, connection metrics or any other such information. Processing circuitry 310 may be configured to control user interface 302 to display information, such as connection metrics, feedback, instructions, or any other information related to operation of external device 104 and / or IMD 106. User interface 302 may be configured to display any information related to the surrounding RFC environment as determined by advertisement analysis instructions 316 and as described throughout this disclosure. User interface 302 may be configured to display any type of feedback described herein, such as feedback indicative of a connection metric which may incorporate different types of RF noise. In some examples, the feedback indicative of the connection metric may be icons and / or notifications, wherein the color, shape, and / or text of the icon and / or notification communicates the connection metric. In some examples, the connection metric may be a numerical number (e.g., higher numbers are better connections), a number of bars, or other such graphical indicators. In some examples, a single red bar can indicate a poor connection metric and therefore high RF noise. In some examples, one or more green bars can indicate a good connection metric and therefore low RF noise. In some examples, tactile and / or audible feedback may be provided instead or in addition to visual information.

[0078] User interface 302 may be configured to display feedback including instructions and recommendations to the user based on the surrounding RFC environment. User interface 302 may request the user move external device 104 closer to IMD 106. In some examples, the feedback requesting the user move external device 104 closer to IMD 106 may comprise an animation showing where and how to move external device 104. User interface 302 may additionally or alternatively be a request to the user to turn off specific devices (e.g., devices indicated by name which may be derived from advertising packets received from that specific device) in the surrounding RFC environment. User interface 302 may indicate to the user which devices nearby are the specific devices. User interface 302 may additionally or alternatively request that the user move away from other devices which are transmitting over the RFC format. User interface 302 may request the user move inside a structure to protect from RFC format communications or other interference that may be encountered outside the structure. Userinterface 302 may also receive user input. The input may be, for example, in the form of pressing a button on a keypad or selecting an icon from a touch screen.

[0079] 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 a movement of external device 104. Information may comprise one or more of an acceleration in an x-direction, acceleration in a y-direction, or an acceleration in a z-direction. The x-direction may be perpendicular to both the y-direction and the z-direction. While the example of FIG. 3 uses accelerometer 340, in some examples external device 104 may additionally, or alternatively, include a gyroscope that may detect the movement and / or generate motion information. Light sensor 342 may be configured to determine light information (e.g., an ambient light level of an environment detected by light sensor 342). Microphone 344 may be configured to determine sound information (e.g., an ambient sound level of an environment detected by microphone 344). For example, microphone 344 may detect speech (e.g., from patient 122 or a caretaker of patient 122).

[0080] Telemetry circuitry 308 may support wireless communication between IMD 106 and external device 104 under the control of processing circuitry 310. Telemetry circuitry 308 may also be configured to communicate with another computing device via wireless communication techniques, or direct communication through a wired connection. In some examples, telemetry circuitry 308 provides wireless communication via an RF or proximal inductive medium. In some examples, telemetry circuitry 308 includes an antenna, which may take on a variety of forms, such as an internal or external antenna.

[0081] Examples of local wireless communication techniques that may be employed to facilitate communication between external device 104 and IMD 106 include RFC protocols such as according to the 802.11 or Bluetooth™ specification sets (e.g., Classic Bluetooth™, Bluetooth™ high speed and Bluetooth™ Low Energy (BLE) protocols) or other standard or proprietary telemetry protocols. In this manner, other external devices 104 may be capable of communicating with external device 104 without needing to establish a secure wireless connection. While examples described herein may refer to connections as using the Bluetooth™ Low Energy (BLE) protocol for establishing a connection and using advertisements compliant with the BLE protocol, other known and future protocols may be used. For example, techniques described herein for establishing a connection between IMD 106 and external device 104 may be compliant with any RFC protocol and / or may use any telemetry frequency.

[0082] Telemetry circuitry 308 may receive the advertisement packet from IMD 106, for example, and connect with another device (e.g., IMD 106) using the received advertisement packet. The advertisement packet may include information on how to connect with theadvertising device, such as, for example, one or more of: (1) media access control (MAC) addresses for IMD 106 and external device 104; (2) a real time-point in time for the transfer to start; (3) an indication of a transfer frequency; (4) an indication of a hop set; (5) a connection interval; or (6) a connection latency. For example, telemetry circuitry 308 may establish a connection with IMD 106 using a transfer frequency and hop set indicated by an advertisement broadcast (e.g., on a set of advertising channels) by IMD 106. In some examples, telemetry circuitry 308 may periodically output an advertisement at an advertising interval (e.g., less than 100 ms, 100 ms to 500 ms, 1 second, more than 1 second, etc.) with an optional random delay. In this example, other devices may connect with telemetry circuitry 308 using the advertisement output by telemetry circuitry 308. Telemetry circuitry 308 may also receive advertisement packets or other signals from other second devices that are not intended for connection but are available and may cause connection issues with IMD 106.

[0083] In some examples, processing circuitry 310 may define the parameters of electrical stimulation therapy, stored in memory 312, for delivering adaptive DBS to patient 112. In one example, processing circuitry 310 of external device 104, via telemetry circuitry 308, issues commands to IMD 106 causing IMD 106 to deliver electrical stimulation therapy via electrodes 116, 118 via leads 114.

[0084] Telemetry circuitry 308 may be configured to initiate a communication session using an advertisement packet. For example, telemetry circuitry 308 may receive (e.g., from telemetry circuitry 208) the advertisement at the specified advertisement rate. The advertisement rate may include a Bluetooth™ Low Energy advertisement rate. The advertisement packet may comprise security information for a communication session and / or connection information for the communication session. For example, telemetry circuitry 308 may establish a communication session using security information for a communication session and / or connection information for the communication session advertised by IMD 106 at an advertisement rate.

[0085] Telemetry circuitry 308 may also sense advertisement packets in the RFC format from other devices in the vicinity of external device 104. Telemetry circuitry 308 may receive advertising packets from the other devices in the vicinity of the external device 104. The quantity of advertising packings from other devices may contribute to the magnitude of the RF noise in the surrounding environment. The advertising packets received from the other devices may comprise security information and / or connection information on the other devices. The connection information may include an advertisement rate and a device name. Telemetry circuitry 308 may be configured to sense the relative received power between the signals received at telemetry circuitry 308. Advertisement analysis instructions 316 may include anyinstructions required by external device 104 to execute the analysis of the RFC advertising packets received from the one or more second devices as described herein.

[0086] In accordance with the techniques of the disclosure, external device 104 may implement received signal analysis of the signals received by telemetry circuitry 308 in processing circuitry 310 based on advertisement analysis instructions 316. The received signals may be received from IMD 106 as well as other devices in the vicinity of external device 104. Techniques described herein may improve a user experience of connecting external device 104 to a low power and slow advertisement rate IMD 106. This implementation would enable the user of external device 104 to get feedback on how to improve a speed at which IMD 106 and external device 104 connect. Power source 320 may include a small rechargeable or non-rechargeable battery and / or a power generation circuit to produce the operating power. Power source 320 may additionally or alternatively include a power connection to a power grid. Techniques described herein may help enable patient 122 to use IMD 106 for a longer time, due to a lower advertisement rate and therefore reduced power demand. Reducing power demand on power source 220 of IMD 106 may thereby reducing replacement surgeries for primary batteries or reduce recharge burden on patients with rechargeable batteries in IMD 106.

[0087] FIG. 4 is a flowchart illustrating an example operation of external device 104 configured to determine a connection metric representative of a radio frequency connection format and provide feedback based on the connection metric. FIG. 4 is discussed with respect to external device 104, processing circuitry 310, and communication circuitry 308 are described for example purposes only. Other external devices and / or circuitry may perform similar functions as described herein.

[0088] External device 104 may sense and receive signals (e.g., advertisement packets) of devices operating in the same radio frequency communication (RFC) format (e.g., Bluetooth™ Low Energy (BLE)) as IMD 106 in the vicinity of external device 104 (400). For example, processing circuitry 310 may control communication circuitry 308 to sense these signals during certain times according to instructions. Processing circuitry 310 may determine a connection metric representative of an aspect of the RFC format in the vicinity of external device 104 (402). The connection metric may be representative of the traffic on the RFC format which may hinder receiving signals from IMD 104 when traffic is relatively high and / or other second devices provide stronger signals for detection by external device 104. External device 104 may output feedback to a user of external device 104 based on the connection metric (404). The connection metric may be indicative of the number of devices in the vicinity of external device 104 and / or the strength at which the other devices are transmitting their advertising packets.

[0089] In the example shown in FIG. 4, processing circuitry 310 of external device 104 may function to control telemetry circuitry 308 of external device 104 to sense and receive signals (e.g., advertisement packets) of devices operating in the same radio frequency communication (RFC) format (400) in the vicinity of external device 104. The sensing and receiving of signals provides information so that external device 104 can test the connection environment in the vicinity of external device 104 for other second devices operating in the radio frequency communication (RFC) format used by IMD 106. Processing circuitry 310 may sense and receive signals from one or more communication protocols, such as Bluetooth™ or Bluetooth Low Energy (ISM bands from 2.402 to 2.48 GHz). Processing circuitry 310 may additionally or alternatively sense and receive signals from one or more other communication protocols such as Radio Frequency Communication Protocols, Bluetooth™, Wi-Fi™, Near-Field Communication (NFC), Near Field Magnetic Induction (NFMI), Long Term Evolution, 5th generation (LTE / 5G), or MedRadio (MICS: Medical Implant Communication Service, MEDS: Medical External Device Service, MBAD: Medical Body Area Network)). Processing circuitry 310 may control telemetry circuitry 308 of external device 104 to receive suitable frequencies based on a frequency telemetry circuitry 208 of IMD 106. In some examples, telemetry circuitry 308 can be configured to only receive signals for the radio frequency communication (RFC) format used by IMD 106 so that only signals which could interfere with the radio frequency communication (RFC) format used by telemetry circuitry 208 of IMD 106 are sensed, received, and analyzed. However, other second devices that also use this RFC format of IMD 106 may still be detectable when external device 104 attempts to establish a communication session with IMD 106.

[0090] Processing circuitry 310 of external device 104 may function to determine a connection metric representative of an aspect of the RFC format (402) used by IMD 106 in the vicinity of external device 104. The connection metric may be indicative and / or correlative with the RF noise in the vicinity of external device 104. The RF noise may correlate to the number of devices in the vicinity of external device 104 and / or the strength at which the other devices are transmitting their advertising packets in the RFC format of IMD 106. External device 104 may control processing circuitry 310 to determine the connection metric based on any number of factors of the sensed signals. In some examples, processing circuitry 310 controls telemetry circuitry 308 to scan across all the available channels for the RFC format and processing circuitry 310 may determine how many other devices, besides IMD 106 are transmitting advertising packets both in the RFC format of IMD 106 and in the vicinity of IMD 106.

[0091] Processing circuitry 310 may calculate a received signal strength indicator (RSSI) for each of the devices which are transmitting advertising packets, including IMD 106 and each of the other devices in a vicinity of external device 104. In some examples, processing circuitry 310calculates the RSSI based on the rate of transmission of advertising packets which are received by telemetry circuitry 308. In some examples, processing circuitry 310 calculates the RSSI based on a ratio of the rate of transmission of advertising packets as indicated by the other device and the rate of advertising packets which are actually received by telemetry circuitry 308, which may be indicative of an attenuation of the sensed signals. Processing circuitry 310 may divide the sensed signals into one or more RFC format channels. In some examples, processing circuitry 310 may determine an RSSI for each of the one or more RFC format channels wherein processing circuitry 310 determines the RSSI based on the rate of transmission of advertising packets on each of the one or more RFC format channels. The number of RFC format channels may be defined by the communication protocol used or may additionally or alternatively be defined by processing circuitry 310. Processing circuitry 310 may additionally or alternatively base the RSSI on a ratio of a received signal strength from each device and an expected received signal strength from each device. In some examples, processing circuitry 310 may base the RSSI on the number of piconets in the vicinity of external device 104. For example, piconets may be an ad hoc network of multiple devices using the same RFC format (e.g., BLE). A larger number of piconets may be indicative of additional traffic, or noise, that may reduce the ability of external device 104 to connect with IMD 106. For example, the number of piconets in the area of the external device can impact data channel utilization needed to establish a connection. This data channel utilization can impact the RSSI, such as higher data channel utilization can lower the received signal strength (e.g., the RSSI).

[0092] Processing circuitry 310 of external device 104 may output feedback to a user of external device 104 through user interface 302 based on the connection metric (404). Processing circuitry 310 may base the feedback on any of: the RSSI of the other devices, the RSSI of each of the one or more RFC format channels, the number of devices transmitting advertising packets, the number of devices in each of the one or more RFC format channels, the number of piconets in the vicinity, and / or the number of devices above a threshold. The feedback may be generated by processing circuitry 310 when processing circuitry 310 determines that such an action would be beneficial to the operation of external device 104 or to the user experience of external device 104 and provide feedback to a user.

[0093] The feedback to the user may be provided to the user through user interface 302, which may be controlled by processing circuitry 310. The feedback provided to the user at user interface 302 may request the user move external device 104 closer to IMD 106. In some examples, the feedback provided to the user at user interface 302 requests the user move external device 104 closer to IMD 106. This instruction may suggest the direction to move external device 104 or show the user where IMD 106 is located on the body. In some examples, userinterface 302 is or includes a display screen. In some examples, the feedback comprises an animation instructing the user where to move external device 104 based on an implantation location of IMD 106. In some examples, if IMD 106 is located in an implantation location above the buttocks of the user and the external device 104 is an application on a mobile device in a hand of patient 112, such positioning of external device 104 and IMD 106 may provide a significant impediment to signal flow due to patient’s 112 body being in between external device 104 and IMD 106; therefore, an animation may show patient 112 moving their handheld external device 104 closer to the IMD 106, perhaps along their side or near their back. In some examples, the animation can show what type of device external device 104 is, such as a patient programmer, a clinician programmer, an application on a mobile device, or another communication device. In some examples, the animation can show where IMD 106 is located. In some examples, user interface 302 can indicate the region where the device is implanted, such as in the pectoral region, the abdomen, the buttock area, near an ankle, or any other region which IMD 106 may be implanted into.

[0094] The feedback provided to the user through user interface 302, which may be controlled by processing circuitry 310, may additionally or alternatively be a request to the user to turn off devices in the vicinity to external device 106. In some examples, the devices requested to be turned off are devices which processing circuitry 310 determined to frequently transmit advertisement packets. In some examples, the devices are devices which processing circuitry 310 determined to transmit advertisement packets across a wide spectrum of RFC channels. In some examples, the devices are devices which processing circuitry 310 determined to be too close to IMD 106. The feedback provided to the user through user interface 302, which may be controlled by processing circuitry 310, may specifically identify which devices to turn off. In some examples, specifically identifying the devices to turn off at user interface 302 may comprise indicating a “Local Name” of the device based on the “Local Name” or “Device Name” contained in RFC format data payload. The feedback provided to the user at user interface 302 may additionally or alternatively request that the user move away from other devices which are transmitting over the RFC format. In some examples, the feedback provided to the user at user interface 302 may comprise an animation to the user to move away from other electronic devices. In some examples, the feedback provided to the user by user interface 302 may comprise a beeping or audio notification indicating that a movement away from other electronic devices is requested, desired, or suitable. The feedback provided to the user by user interface 302 may request the user to move inside a structure to protect external device 104 from RFC format communications from other devices or other interference that may be encountered outside of astructure. The feedback provided to the user at user interface 302 may request the user move near a metal wall or metal box.

[0095] FIG. 5 is a flowchart illustrating an example operation of an external device 104 configured to determine a connection metric representative of a radio frequency connection based on a received signal strength indicator and provide feedback to a user based on the connection metric. FIG. 5 is discussed with respect to external device 104, processing circuitry 310, and communication circuitry 308 for example purposes only. However, other external devices and circuitry may perform similar functions as described herein.

[0096] In the example shown in FIG. 5, processing circuitry 310 of external device 104 may control communication circuitry 308 to sense and receive signals (e.g., advertisement packets) of devices operating in the same radio frequency communication (RFC) format as IMD 106 (500) (e.g., Bluetooth™ Low Energy (BLE)) in the vicinity of external device 104. Step 500 may be performed substantially similarly to step 400 of FIG. 4.

[0097] External device 104 may determine how many devices are operating in the same radio frequency communication (RFC) format as IMD 106 (502). Processing circuitry 310 of external device 104 may determine how many other devices, besides IMD 106 are transmitting advertising packets on the same RFC format as IMD 106. In some examples, this is a count of the number of unique medium access control (MAC) addresses received in advertising packets and stored in memory 312 during step 500.

[0098] External device 104 may calculate a received signal strength indicator (RSSI) of each of the devices operating in the same radio frequency communication (RFC) format as IMD 106 (504). Processing circuitry 310 of external device 104 may determine the RSSI of each received signal of the devices operating in the vicinity of external device 104 and advertising on the same RFC format as IMD 106. In some examples, processing circuitry 310 of external device 104 determines the RSSI based on the rate of transmission of advertising packets. In some examples, processing circuitry 310 of external device 104 determines the RSSI based on the attenuation of the sensed signals compared to an expected signal strength based on information in the advertising packets. Processing circuitry 310 of external device 104 may divide the sensed signals into one or more RFC format channels. In some examples, processing circuitry 310 of external device 104 determines the RSSI for each of the one or more RFC format channels based on the rate of transmission of advertising packets for each of the devices on each of the one or more RFC format channels. Processing circuitry 310 of external device 104 may additionally or alternatively determine the RSSI based on a ratio of a received signal strength from the other devices and an expected received signals strength from the other devices. In some examples, the RSSI may be based on the number of piconets in the vicinity of external device 104.

[0099] External device 104 may rank the RS SI of each of the devices operating in the same radio frequency communication (RFC) format as IMD 106 (506). Processing circuitry 310 of external device 104 may rank each of the devices sensed from the same RFC format as IMD 106. In some examples, processing circuitry 310 may rank the other devices based on the RS SI of each device. In some examples, processing circuitry 310 may rank the other devices based on the RSSI for each of the one or more RFC format channels. In some examples, processing circuitry 310 may rank the other devices based on how many devices are operating in each of the one or more RFC format channels.

[0100] External device 104 may apply a threshold to the ranked RSSI devices (508). Processing circuitry 310 of external device 104 may apply a threshold to the ranking of the devices. In some examples, processing circuitry 310 of external device 104 applies the threshold to each device for which signals are received. In some examples, processing circuitry 310 of external device 104 applies the threshold to each device for which an RSSI was calculated. In some examples, processing circuitry 310 of external device 104 applies the threshold to each of the one or more RFC format channels. In some examples, this ranking and thresholding may then determine a channel which is less congested than the others and thereby determine a channel which would be better suited for communication between external device 104 and IMD 106. The threshold may be an absolute value above which external device’s 104 operations are impacted. In some examples, the threshold may be a relative value above which the specific user’s experience is impacted. In some examples, the threshold may be a relative value, wherein the threshold may be based on a value received from IMD 106 and / or user interface 302. In some examples, the threshold applied by processing circuitry 310 of external device 104 may be an RSSI two orders of magnitude greater than the RSSI of IMD 106. In some examples, the threshold applied to other devices by processing circuitry 310 of external device 104 may be between 1 and 3 orders of magnitude greater than the RSSI of IMD 106.

[0101] External device 104 may then output feedback to a user of external device 104 based on the ranked list of ESSI devices (510). The feedback may be presented via a user interface of external device 104 and may be representative of the ranked list and / or other information associated with the detected devices on the RFC format. Step 510 may be performed substantially similarly to step 404 of FIG. 4.

[0102] FIG. 6 is a flowchart illustrating an example operation of external device 104 configured to determine a connection metric representative of a radio frequency connection format and provide detailed feedback to a user of external device 104 based on the connection metric. FIG. 6 is discussed with respect to external device 104, processing circuitry 310, andcommunication circuitry 308 for example purposes only. However, other external devices 104 and circuitry may perform similar functions as described herein.

[0103] In the example shown in FIG. 6, processing circuitry 310 of external device 104 may sense and receive signals (e.g., advertisement packets) of devices operating in the same radio frequency communication (RFC) format as IMD 106 (e.g., Bluetooth™ Low Energy (BLE)) in the vicinity of external device 104 (600). Step 600 may be performed substantially similarly to step 400 of FIG. 4. Processing circuitry 310 of external device 104 may function to determine a connection metric representative of an aspect of the RFC format used by IMD 106 in the vicinity of external device 104 (602). Step 602 may be performed substantially similarly to step 402 of FIG. 4.

[0104] Processing circuitry 310 of external device 104 may control user interface 302 to provide feedback to a user (604). Processing circuitry 310 may determine which type of feedback to provide based on the connection metric. In some examples, processing circuitry 310 may provide different feedback on an escalating basis based on whether or not the connection metric improved (e.g., first request the user to move external device 104 and then request the user to turn off other second devices). In some examples, the feedback provided to the user by user interface 302 may comprise a beeping or audio notification. In some examples, the feedback provided to the user by user interface 302 may comprise a flashing light notification. In some examples, the feedback provided to the user by user interface 302 may comprise haptic feedback. In some examples, the feedback provided to the user by user interface 302 may comprise visual indication to the user of external device 104, user interface 302 may comprise a display, such as a liquid crystal (LCD), light-emitting diode (LED), or organic light-emitting diode (OLED). User interface 302 may provide one, two, three, or more different feedback modalities (e.g., visual, audio, tactile) at any given time.

[0105] The feedback, which processing circuitry 310 can control user interface 302 to display to the user, may include instructions requesting the user move external device 104 closer to IMD 106 (606). In some examples, the feedback requests the user move external device 104 closer to IMD 106. The feedback which processing circuitry 310 causes user interface 302 to display to the user may include an animation showing where to move the external device 104 (608). In some examples, the animation can be displayed on a screen of user interface 302. In some examples, the animation can show what type of device external device 104 is, such as a patient programmer, a clinician programmer, an application on a mobile device, or another communication device. In some examples, the animation can show where IMD 106 is located. In some examples, IMD 106 may be implanted in the pectoral region, the abdomen, the buttock area, near an ankle, or any other region which IMD 106 may be implanted into. In someexamples, the animation can show what type of device IMD 106 is. In some examples, the animation may indicate the length of time to hold external device 104 in the new location.

[0106] The feedback which processing circuitry 310 controls user interface 302 to display to the user may additionally or alternatively be a request to the user to turn off specific devices (610). The specific devices may be second devices which were ranked above a threshold. In some examples, the specific devices are second devices which transmit advertisement packets more frequently than IMD 106. In some examples, the specific devices are second devices which transmit advertisement packets across a wide spectrum of RFC format channels. In some examples, the specific devices are second devices which are nearby to external device 104 and therefore are not attenuated before reaching external device 104.

[0107] The feedback which processing circuitry 310 causes user interface 302 to display to the user may specifically identify which second devices nearby are the specific devices (612). In some examples, the feedback may indicate a “Local Name” of the specific device based on the “Local Name” or “Device Name” sent out in the RFC format data payload contained within the advertising packet. For example, if the user’s headphones were nearby and transmitting advertising packets frequently, transmitting advertising packets on the same RFC format channel as IMD 106, transmitting advertising packets in close proximity to IMD 106 and / or external device 104, and / or transmitting advertising packets frequently across many channels of the same RFC format as IMD 106, the user may be prompted by user interface 302 to “please power down ‘[user’s] headphones’.”

[0108] In some examples, the feedback which processing circuitry 310 causes user interface 302 to display to the user may additionally or alternatively request that the user move away from other devices which are transmitting over the same RFC format as IMD 106 (614). The feedback to the user may include an animation to the user to move away from other electronic devices. In some examples, the feedback to the user may comprise a beeping or audio notification to the user to indicate that a movement away from other electronic devices is requested, desired, or suitable. For example, if the user is in an electronically noisy area (e.g., a coffee shop, electronics store, computer lab, classroom), user interface 302 may prompt the user to move away from the current location before attempting connection again.

[0109] Processing circuitry 310 can also control user interface 302 to display feedback to the user that can include instructions or a request the user move inside a structure (616) to protect from RFC format communications or other interference that may be encountered outside of a structure. The feedback to the user may additionally or alternatively request the user move near a metal wall or metal box.

[0110] After user interface 302 displays the feedback in the form as determined from stored instructions, processing circuitry 310 may continue to monitor detected signals and update the connection metric if any signals from other second devices have changed (620). In response to a change to the connection metric, processing circuitry 310 may update the feedback to provide more accurate instructions to the user regarding possible improvements to establish a connection with IMD 106 and then provide that updated feedback again (604). At any point during the feedback process that user interface 302 determines that external device 104 has established the connection with IMD 106 and noise is no longer an issue, processing circuity 310 may present an indication that the connection is a success, stable, or otherwise no further adjustment needs to be made. Processing circuitry 310 may cause user interface 302 to then exit the feedback process. [OHl] FIG. 7 is a flowchart illustrating an example operation of an external device 104 configured to determine a connection metric representative of a radio frequency connection format in response to opening an application. FIG. 7 is discussed with respect to external device 104, processing circuitry 310, and communication circuitry 308 for example purposes only. However, other external devices 104 and circuitry may perform similar functions as described herein.

[0112] External device 104 may trigger processing circuitry 310 to perform an analysis of the connection metrics in response to receiving an indication that a user opened an application through user interface 302 on external device 104 (700). The application may be an application that facilitates programming or other interaction with IMD 106, for example, where external device 104 and IMD 106 may need to establish a communication session. In some examples, feedback is given to the user on the connection environment before external device 104 attempts a connection with IMD 106. In some examples, providing feedback to the user before attempting a connection may improve a user experience as the connection may be established faster and / or enable a higher rate of data transfer after the feedback has been implemented by the user. In other examples, picking up external device 104 may trigger testing same radio frequency communication (RFC) format as IMD 106 in the nearby environment for a quality of the connection environment instead of external device 104 being triggered by opening an application. In some examples, triggering processing circuitry 310 to perform an analysis of the connection metrics in response to external device 104 being picked up can enable external device 104 to provide feedback more quickly than waiting to perform the analysis until after the user opens the application. In some examples, processing circuitry 310 may detect, via accelerometer signals, that a user picked up or moved external device 104 and may identify that as a trigger to initiate a connection. Processing circuitry 310 may then initiate a connection metrics test uponopening an application or upon picking up external device 104 may reduce a time user spends waiting for the connection analysis.

[0113] External device 104 may sense and receive signals (e.g., advertisement packets) of devices operating in the same radio frequency communication (RFC) format as IMD 106 (702) (e.g., Bluetooth™ Low Energy (BLE)) in the vicinity of external device 104. Step 702 may be performed substantially similarly to step 400 of FIG. 4. External device 104 may determine a connection metric representative of an aspect of the RFC format (704) in the vicinity of external device 104. Step 704 may be performed substantially similarly to step 402 of FIG. 4. External device 104 may output, for display or other presentation, feedback to a user of external device 104 based on the connection metric (706). Step 706 may be performed substantially similarly to step 404 of FIG. 4. The connection metric may be indicative of the number of devices in the vicinity of external device 104 and / or the strength at which the other devices are transmitting their advertising packets.

[0114] FIG. 8 is a flowchart illustrating an example operation of an external device 104 configured to determine a connection metric representative of a radio frequency connection format in response to a user request to connect. FIG. 8 is discussed with respect to external device 104, processing circuitry 310, and communication circuitry 308 for example purposes only. However, other external devices 104 and circuitry may perform similar functions as described herein.

[0115] Processing circuitry 310 may receive a user request for external device 104 to connect to IMD 106 and, responsive to receiving the request, generate a connection metric based on sensed signals (800). In some examples, processing circuitry 310 may initiate testing of the nearby environment for the quality of the connection environment in response to detecting the request for connection, and may, based on the quality of the connection environment, indicate feedback to the user before attempting a connection with IMD 106. In some examples, feedback to the user prior to attempting a connection may improve user experience as the user is then able to implement feedback to decrease a connection time or a failure rate of connection prior to waiting for a first connection attempt.

[0116] External device 104 may sense and receive signals (e.g., advertisement packets) of devices operating in the same radio frequency communication (RFC) format as IMD 106 (e.g., Bluetooth™ Low Energy (BLE)) in the vicinity of external device 104 (802). Step 802 may be performed substantially similarly to step 400 of FIG. 4. External device 104 may determine a connection metric representative of an aspect of the RFC format (804) in the vicinity of external device 104. Step 804 may be performed substantially similarly to step 402 of FIG. 4. External device 104 may output, for presentation via user interface 302, feedback to a user of externaldevice 104 based on the connection metric (806). Step 806 may be performed substantially similarly to step 404 of FIG. 4. The connection metric may be indicative of the number of devices in the vicinity of external device 104 and / or the strength at which the other devices are transmitting their advertising packets.

[0117] FIG. 9 is a flowchart illustrating an example operation of an external device 104 configured to determine a connection metric representative of a radio frequency connection format in response to a timeout threshold. FIG. 9 is discussed with respect to external device 104, processing circuitry 310, and communication circuitry 308 for example purposes only. However, other external devices 104 may perform similar functions as described herein.

[0118] Processing circuitry 310 of external device 104 may initiate a connection to IMD 106 in response to an input from sensors 301, user interface 302, and / or telemetry circuitry 308 interpreted by processing circuitry 310 as a request to initiate a connection (e.g., as described in FIG. 8). In response to the request to initiate a connection, external device 104 can attempt to connect to IMD 106 via telemetry circuitry 308 for a period of time less than the timeout threshold (900). If a connection is established, processing circuitry 310 can skip steps 902-910 because the communication session was established without analysis or feedback to the user required. In some examples, attempting to form a connection between external device 106 and IMD 104 before performing the analysis (i.e., the initial connection) is conditional on prior successful connections between external device 106 and IMD 104 which did not require feedback. In some examples, the timeout threshold is increased if prior initial connection sessions were successful. In some examples, the timeout threshold is decreased if prior initial connection sessions were unsuccessful. In some examples, the timeout threshold can be 45 seconds. In some examples, the timeout threshold can be 20 seconds, 30 seconds, 60 seconds, or 90 seconds.

[0119] In contrast, upon a connection failure due to an elapse of too much time or inability to find IMD 106, wither or not IMD 106 is in a digitally crowded environment, external device 104 can proceed to sense and receive signals (e.g., advertisement packets) of devices operating in the same radio frequency communication (RFC) format as IMD 106 (e.g., Bluetooth™ Low Energy (BLE)) in the vicinity of external device 104 (902). Step 902 may be performed substantially similarly to step 400 of FIG. 4. External device 104 may determine a connection metric representative of an aspect of the RFC format in the vicinity of external device 104 (904). Step 904 may be performed substantially similarly to step 402 of FIG. 4. External device 104 may output feedback to a user of external device 104 based on the connection metric (906). Step 906 may be performed substantially similarly to step 404 of FIG. 4. The connection metric may beindicative of the number of devices in the vicinity of external device 104 and / or the strength at which the other devices are transmitting their advertising packets.

[0120] Processing circuitry 310 of external device 104 may wait for input from user interface 302 to indicate that a user has acknowledged the feedback (908). After user has acknowledged the feedback, external device may assumed that the user has implemented the feedback. In some examples, processing circuitry 310 may verify that the feedback was implemented before clearing the feedback. Once the feedback is acknowledged or cleared, then processing circuitry 310 may restart the process (910). By providing an automatic restart to step 900, processing circuitry 310 can enable external device 104 to begin connecting shortly after the feedback has been acknowledged, reducing extra time before restarting the connection. In some examples, providing feedback to the user on how to improve a connection environment before attempting a reconnection may improve a quality of the user experience as the user may be less like to get frustrated by repeated connection failures.

[0121] The following are examples of systems, devices, and techniques described in this disclosure.

[0122] Example 1. A system comprising: communication circuitry configured to: communicate with a first device via a radio frequency (RF) communication format; and sense signals indicative of one or more second devices operating via the RF communication format; and processing circuitry configured to: determine, based on the signals, a connection metric representative of communication via the RF communication format; and output, for presentation to a user of the system, feedback based on the connection metric.

[0123] Example 2. The system of example 1, wherein the RF communication format is Bluetooth Low Energy (BLE).

[0124] Example 3. The system of any of examples 1 or 2, wherein the signals comprise BLE advertising and data packets.

[0125] Example 4. The system of any of examples 1 through 3, wherein the processing circuitry is further configured to determine signal amplitudes of the signals over a frequency range associated with the RF communication format.

[0126] Example 5. The system of example 4, wherein the frequency range is subdivided into a plurality of channels, and wherein the processing circuitry is further configured to determine a Received Signal Strength Indicator (RSSI) for each channel of the plurality of channels.

[0127] Example 6. The system of any of examples 1 through 5, wherein the processing circuitry is configured to determine the connection metric by determining the connection metric based at least in part on one or more of a quantity of second devices, a received signal strength indicator from the first device, a RSSI from each of the second devices, an expected RSSI fromthe first device, the RSSI for each channel of a plurality of channels of the signals, or a quantity of piconets.

[0128] Example 7. The system of any of examples 1 through 6, wherein the processing circuitry is configured to control a user interface to present the feedback as at least a notification to the user to move the communication circuitry closer to the first device.

[0129] Example 8. The system of any of examples 1 through 7, wherein the processing circuitry is configured to control a user interface to present the feedback as at least an animation visually indicating to the user how to move the communication circuitry closer to the first device.

[0130] Example 9. The system of any of examples 1 through 8, wherein the processing circuitry is configured to control a user interface to present the feedback as at least a notification to the user to turn off at least one second device of the one or more second devices.

[0131] Example 10. The system of any of examples 1 through 9, wherein the processing circuitry is configured to control a user interface to present the feedback as at least a notification to the user identifying at least one specific second device of the one or more second devices to turn off.

[0132] Example 11. The system of any of examples 1 through 10, wherein the processing circuitry is configured to control a user interface to present the feedback as at least a notification to the user to move the communication circuitry and the first device a farther distance from one or more of the second devices.

[0133] Example 12. The system of any of examples 1 through 11, wherein the first device is an implantable medical device.

[0134] Example 13. The system of any of examples 1 through 12, further comprising an external programmer comprising the communication circuitry and the processing circuitry, wherein the external programmer is configured to communicate with the first device.

[0135] Example 14. A method comprising: communicating, by communication circuity, with a first device via a radio frequency (RF) communication format; sensing, by the communication circuity, signals indicative of one or more second devices operating via the RF communication format; determining, by processing circuitry and based on the signals, a connection metric representative of communication via the RF communication format; and outputting, by the processing circuitry and for presentation to a user of a system comprising the communication circuitry, feedback based on the connection metric.

[0136] Example 15. The method of example 14, wherein the RF communication format is Bluetooth Low Energy (BLE), and wherein the signals comprise BLE advertising and data packets.

[0137] Example 16. The method of any of examples 14 or 15, wherein sensing the signals comprises, responsive to opening an application on an external programmer, controlling the communication circuitry to sense the signals.

[0138] Example 17. The method of any of examples 15 or 16, wherein the determining the connection metric further comprises: determining a quantity of second devices operating in the RF communication format; determining a Received Signal Strength Indicator (RSSI) of each second device of the one or more second devices; ranking the one or more second devices based at least in part on their respective RSSI scores; and applying a threshold to the RSSI of each second device of the one or more second devices.

[0139] Example 18. The method of example 17, wherein outputting the feedback indicative of the connection metric further comprises: controlling a user interface to present the feedback indicative of which second devices of the ranked one or more second devices are above the threshold; and controlling the user interface to present a request that the user at least one of deactivate the one or more second devices above the threshold or move the communication circuitry away from the one or more second devices above the threshold.

[0140] Example 19. The method of any of examples 15 through 18, wherein outputting the feedback indicative of the connection metric further comprises: displaying, via the processing circuitry, an animation visually indicating to the user how to move the communication circuitry closer to the first device based on a known location of the first device.

[0141] Example 20. The method of any of examples 15 through 19, further comprising controlling a user interface to present the feedback as at least a notification to the user to turn off at least one second device of the one or more second devices.

[0142] Example 21. A non-transitory computer-readable storage medium comprising instructions that, when executed, causes the processing circuitry to: control communication circuitry to communicate with a first device via a radio frequency (RF) communication format; control the communication circuitry to sense signals indicative of one or more second devices operating via the RF communication format; determine, based on the signals, a connection metric representative of communication via the RF communication format; and output, for presentation to a user of the system, feedback indicative of the connection metric.

[0143] The techniques described in this disclosure may be implemented, at least in part, in hardware, software, firmware, or any combination thereof. For example, various aspects of the described techniques may be implemented within one or more processors, including one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components. The term “processor” or“processing circuitry” may generally refer to any of the foregoing logic circuitry, alone or in combination with other logic circuitry, or any other equivalent circuitry. A control unit comprising hardware may also perform one or more of the techniques of this disclosure.

[0144] Such hardware, software, and firmware may be implemented within the same device or within separate devices to support the various operations and functions described in this disclosure. In addition, any of the described units, modules or components may be implemented together or separately as discrete but interoperable logic devices. Depiction of 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 realized by separate hardware or software components. Rather, 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.

[0145] The techniques described in this disclosure may also be embodied or encoded in a computer-readable medium, such as a computer-readable storage medium, containing instructions. Instructions embedded or encoded in a computer-readable storage medium may cause a programmable processor, or other processor, to perform the method, e.g., when the instructions are executed. Computer readable storage media may include random access memory (RAM), read only memory (ROM), programmable read only memory (PROM), erasable programmable read only memory (EPROM), electronically erasable programmable read only memory (EEPROM), flash memory, a hard disk, a CD-ROM, a floppy disk, a cassette, magnetic media, optical media, or other computer readable media.

[0146] Various examples have been described. These and other examples are within the scope of the following claims.

Claims

WHAT IS CLAIMED IS:

1. A system comprising: communication circuitry configured to: communicate with a first device via a radio frequency (RF) communication format; and sense signals indicative of one or more second devices operating via the RF communication format; and processing circuitry configured to: determine, based on the signals, a connection metric representative of communication via the RF communication format; and output, for presentation to a user of the system, feedback based on the connection metric.

2. The system of claim 1, wherein the RF communication format is Bluetooth Low Energy (BLE).

3. The system of any of claims 1 or 2, wherein the signals comprise BLE advertising and data packets.

4. The system of any of claims 1 through 3, wherein the processing circuitry is further configured to determine signal amplitudes of the signals over a frequency range associated with the RF communication format.

5. The system of claim 4, wherein the frequency range is subdivided into a plurality of channels, and wherein the processing circuitry is further configured to determine a Received Signal Strength Indicator (RSSI) for each channel of the plurality of channels.

6. The system of any of claims 1 through 5, wherein the processing circuitry is configured to determine the connection metric by determining the connection metric based at least in part on one or more of a quantity of second devices, a received signal strength indicator from the first device, a RSSI from each of the second devices, an expected RSSI from the first device, the RSSI for each channel of a plurality of channels of the signals, or a quantity of piconets.

7. The system of any of claims 1 through 6, wherein the processing circuitry is configured to control a user interface to present the feedback as at least a notification to the user to move the communication circuitry closer to the first device.

8. The system of any of claims 1 through 7, wherein the processing circuitry is configured to control a user interface to present the feedback as at least an animation visually indicating to the user how to move the communication circuitry closer to the first device.

9. The system of any of claims 1 through 8, wherein the processing circuitry is configured to control a user interface to present the feedback as at least a notification to the user to turn off at least one second device of the one or more second devices.

10. The system of any of claims 1 through 9, wherein the processing circuitry is configured to control a user interface to present the feedback as at least a notification to the user identifying at least one specific second device of the one or more second devices to turn off.

11. The system of any of claims 1 through 10, wherein the processing circuitry is configured to control a user interface to present the feedback as at least a notification to the user to move the communication circuitry and the first device a farther distance from one or more of the second devices.

12. The system of any of claims 1 through 11, wherein the first device is an implantable medical device.

13. The system of claim 12, wherein the implantable medical device comprises stimulation circuitry configured to deliver electrical stimulation to a patient.

14. The system of any of claims 1 through 13, further comprising an external programmer comprising the communication circuitry and the processing circuitry, wherein the external programmer is configured to communicate with the first device.

15. A non-transitory computer-readable storage medium comprising instructions that, when executed, causes the processing circuitry to perform the functions of any of claims 1 through 14.

Images