Integration of electrode sensing results with electrode distribution

Abstract

Devices, systems, and techniques are described for generating and presenting recommended ratings for different potential stimulation electrodes. An example system includes a memory configured to store a user interface, telemetry circuitry, and processing circuitry coupled to the memory and the telemetry circuitry. The processing circuitry is configured to generate a first screen presenting a representation of the plurality of electrodes and a signal quality indication for at least one of the plurality of electrodes based on the received signal information for presentation via the user interface. The processing circuitry is configured to obtain, via the first screen, a selection of one or more of at least one of the plurality of electrodes as a stimulation electrode. The processing circuitry is configured to program, via the telemetry circuitry, the implantable medical device to provide electrical stimulation according to a stimulation procedure defining a stimulation electrode.

Description

[0001] This application is a PCT application claiming priority and benefit to U.S. Provisional Patent Application No. 63 / 516,455, filed July 28, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates to medical devices, and more specifically, to sensing electrical signals from a patient. Background Technology

[0003] Implantable medical devices, such as electrostimulators or therapeutic agent delivery devices, have been proposed for various therapeutic applications, including deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, functional electrical stimulation, or the delivery of drugs, insulin, analgesics, or anti-inflammatory agents to target tissue sites within a patient. In some therapeutic systems, the implantable electrostimulator delivers electrotherapy to target tissue sites within a patient via two or more electrodes, which may be deployed via medical leads and / or on the stimulator's housing, or both. In some therapeutic systems, therapy may be delivered via leads and / or specific combinations of electrodes carried on the stimulator's housing.

[0004] During a programming session, which may occur during medical device implantation, during a trial session, or in a clinic or during a remote follow-up session after the medical device has been implanted in a patient, a clinician may generate one or more therapy procedures (also called therapy parameter sets) that are found to provide an effective treatment to the patient, where each therapy procedure may define values ​​for a therapy parameter set. The medical device may deliver the treatment to the patient according to one or more stored therapy procedures. In the case of electrical stimulation, the therapy parameters may define the characteristics of the electrical stimulation waveform to be delivered. For example, in an example of delivering electrical stimulation in the form of electrical pulses, the therapy parameters may include an electrode configuration that includes a combination and polarity of stimulating electrodes, amplitude (which may be current or voltage amplitude), pulse width, and pulse rate. Summary of the Invention

[0005] Generally, this disclosure relates to apparatus, systems, and methods for presenting and receiving information related to the programming of therapeutic parameters within a system, such as stimulating electrodes and / or electrode segments (which may be considered electrodes for the purposes of this disclosure), the system being able to identify, using sensed signals such as LFP (local field potential), evoked compound action potential (eCAP), or other evoked responses, the electrodes that may be most suitable for delivery of stimulation on one or more implanted leads.

[0006] For example, the system is configured to receive sensing signals and, based on these signals, identify the electrode on one or more implanted leads that is perhaps best suited for stimulus delivery. The system can use a specific electrode as a reference (e.g., a reference electrode) to sense the signal between each electrode on the lead. Such sensing can be referred to as unipolar sensing when the spacing between the sensing electrodes is significantly larger than the spatial extent of the signal source. For example, unipolar sensing may include sensing when the spacing between the sensing electrodes is in the range of 30 mm–40 mm or larger than the spatial extent of the signal source (which may be in the range of 3 mm–9 mm). In some examples, the reference electrode is an electrode on a lead different from the lead including the sensing electrode. In some examples, the reference electrode may be the farthest or nearest electrode on the same lead as the sensing electrode. In some examples, the system may perform signal sensing in this manner on each lead of the system. In this way, the system can sense signals between different electrodes to highlight the relevant differences between stimuli delivered via each of these electrodes.

[0007] The system can determine a signal quality indicator based on received signal information, which may include a recommended level or rating for the electrodes based on the sensed signals, and present the signal quality indicator on a programming screen where clinicians can select which electrodes to use as stimulation electrodes. For example, the signal quality indicator can be integrated into the same screen from which the user selects the electrodes to be used as stimulation electrodes. The clinician can then select which electrodes to use as stimulation electrodes for a given therapeutic procedure while viewing the signal quality indicator via the programming screen.

[0008] As an example, a medical device system includes: a memory configured to store a user interface; telemetry circuitry; and processing circuitry coupled to the memory and the telemetry circuitry, the processing circuitry being configured to: generate a first screen presenting a representation of a plurality of electrodes and a signal quality indication based on received signal information for at least one of the plurality of electrodes, for presentation via the user interface; obtain selection of one or more of the plurality of electrodes as stimulating electrodes via the first screen of the user interface; and program an implantable medical device (IMD) via the telemetry circuitry to provide electrical stimulation according to a stimulation program that defines the stimulating electrodes.

[0009] As another example, a method includes: generating a first screen that presents a representation of a plurality of electrodes and a signal quality indication based on received signal information for at least one of the plurality of electrodes, for presentation via a user interface; obtaining selection of one or more of the plurality of electrodes as stimulating electrodes via the first screen of the user interface; and programming an implantable medical device (IMD) via telemetry circuitry to provide electrical stimulation according to a stimulation program that defines the stimulating electrodes.

[0010] As another example, a non-transitory computer-readable storage medium stores instructions that, when executed, cause processing circuitry to: generate a first screen presenting a representation of a plurality of electrodes and a signal quality indication based on received signal information for at least one of the plurality of electrodes, for presentation via a user interface; obtain selection of one or more of the plurality of electrodes as stimulating electrodes via the first screen of the user interface; and program an implantable medical device (IMD) via telemetry circuitry to provide electrical stimulation according to a stimulation program that defines the stimulating electrodes.

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

[0012] Figure 1 This is a conceptual diagram illustrating an example deep brain stimulation (DBS) system configured to deliver electrical stimulation therapy to tissue sites within a patient's brain, according to one or more aspects of this disclosure.

[0013] Figure 2 This is a functional block diagram illustrating components of an example medical device according to one or more aspects of this disclosure.

[0014] Figure 3 This is a functional block diagram illustrating components of an example medical device programmer according to one or more aspects of this disclosure.

[0015] Figure 4 This is a conceptual diagram of an example user interface lead screen illustrating a representation of leads comprising multiple electrodes according to one or more aspects of this disclosure.

[0016] Figure 5 This illustrates, according to one or more aspects of this disclosure, a drop-down menu. Figure 4 A conceptual diagram of a sample user interface leader screen.

[0017] Figure 6This is a conceptual diagram illustrating an example user interface result screen that displays, according to one or more aspects of this disclosure, leads of multiple electrodes and corresponding recommended levels or ratings for some of the electrodes.

[0018] Figure 7 This is a conceptual diagram illustrating another example user interface result screen that displays, according to one or more aspects of this disclosure, leads of multiple electrodes and corresponding recommended levels or ratings for some of the electrodes.

[0019] Figure 8 This illustrates, according to one or more aspects of this disclosure, instructions for user input. Figure 6 A conceptual diagram of the example user interface result screen.

[0020] Figure 9 This illustrates, according to one or more aspects of this disclosure, the selection of stimulation electrodes via user input. Figure 6 and Figure 8 The following is a conceptual diagram of the example user interface result screen. Screen 900 can be the screen in screen 89.

[0021] Figure 10 This is a conceptual diagram of an example user interface lead screen illustrating one or more aspects of this disclosure, including leads of a selected electrode as a stimulating electrode and providing input of other parameters associated with the therapeutic procedure.

[0022] Figure 11 This is a conceptual diagram illustrating an example screen including power spectral density according to one or more techniques of this disclosure.

[0023] Figure 12 This is a flowchart of an example technique for selecting an electrode combination to deliver electrical stimulation according to one or more techniques of this disclosure. Detailed Implementation

[0024] When clinicians program therapeutic procedures (such as stimulation procedures) for implantable medical devices (IMDs), they can test every possible combination of electrodes that can be used as stimulation electrodes in the procedure. For example, clinicians can use sensed signals to determine which combination of electrodes should be used as the stimulation electrode. This programming has become more difficult as the number of electrodes used with IMDs has increased and the use of segmented electrodes has become more prevalent, due to the dramatic increase in the number of possible combinations of electrodes to be used as stimulation electrodes. Analyzing and retaining sensed signals is impossible in the human brain, especially for systems using a large number of electrodes and / or segmented electrodes.

[0025] Generally, this disclosure relates to providing a user interface that facilitates clinicians in viewing suggested or recommended electrodes for use as stimulating electrodes on the same screen where electrodes are programmed as stimulating electrodes. Providing information on which electrodes are suggested as stimulating electrodes on the same screen where clinicians can program electrodes as stimulating electrodes simplifies the programming process. For example, providing clinicians with detailed test results that can be analyzed for each of a large number of electrodes and requiring them to navigate through other screens to select the desired electrode for use as a stimulating electrode can be complex. When humans navigate through one or more other screens from which they select electrodes as stimulating electrodes for a given therapeutic procedure, they may not be able to retain all the information provided on the individual test results screens in their minds. The use of LFPs to identify one or more electrodes that may be most suitable for delivery of stimulation on an implantable lead is discussed in U.S. Patent Publication 2022-0387802 A1, which is incorporated herein by reference in its entirety. The technology of this disclosure may be particularly useful for such systems.

[0026] Signal quality indicators generated by the system's stimulating electrodes (such as recommendations for electrodes used as stimulating electrodes) can identify which electrodes among multiple electrodes, such as those in an implanted lead, are suitable for delivering electrical stimulation for a given therapeutic procedure, based on the utilization of sensed electrical signals (such as LFP in the brain). In some examples, the system may generate signal quality indicators for some or all of the electrodes. Recommendations for these electrodes may be based on the signal quality associated with the electrodes. Signal quality can represent characteristics of the sensed signal from the electrodes, such as signal amplitude (e.g., total amplitude or amplitude from one or more frequency bands), noise present in the signal, etc. Although this document describes the brain primarily, the techniques disclosed herein can be used to identify which electrodes are suitable for delivering electrical stimulation to other parts of the anatomical structure, such as the spinal cord, pelvic floor, peripheral nerves, etc.

[0027] Many brain disorders can be associated with abnormal brain function. In one example, Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by the loss of dopaminergic neurons in the basal ganglia-thalamus-cortex. As PD progresses, the disease may present with one or more characteristic motor dysfunctions, including one or more of akinesia, bradykinesia, rigidity, and tremor. In some examples, deep brain stimulation (DBS) therapy can be used to deliver electrical stimulation to treat motor symptoms in patients with drug-resistant PD. In some examples, DBS therapy may involve implanting one or more leads unilaterally or bilaterally into the brain to deliver electrical stimulation to target structures in the basal ganglia. The selection of effective stimulation parameters for DBS therapy can be time-consuming for both clinicians (e.g., physicians, nurses, or technicians) and patients. Therefore, it is desirable to reduce the amount of time spent selecting stimulation parameters. Furthermore, the trial-and-error process used to determine the appropriate electrode combination and / or other stimulation parameters can subject patients to undesirable side effects during this lengthy process and / or result in fewer than optimal stimulation parameters, thus reducing the therapeutic value of any therapy delivered.

[0028] Target areas associated with a disease (e.g., PD) can generate signals of interest (e.g., beta waves that can indicate symptoms such as tremor in PD). As described herein, the system can sense signals between different combinations of electrodes to highlight relevant differences between the sensed signals from each electrode. The system can then generate information about these signals (e.g., may include recommended signal quality), such as information that can be presented to a clinician and / or information that the system uses to select parameter values ​​for stimulation (e.g., which electrodes should be used as two or more stimulating electrodes). The sensed signals may be located between electrodes at different circumferential positions on one lead and / or electrodes at different axial positions on another lead and a reference electrode (e.g., unipolar sensing). The clinician or the system can then determine the parameters for stimulation based on one or more characteristics of these acquired signals, rather than having to test the stimulation provided by each electrode combination. For example, parameters for stimulation may include which electrodes are to be used for stimulation, the polarity of the electrodes used for stimulation (e.g., anode or cathode), and parameters of the electrical stimulation signal such as voltage or current amplitude, frequency, waveform shape, on / off cycle state (e.g., if the cycle is "off," the stimulation is always on, and if the cycle is "on," the stimulation is cyclically on and off), and in the case of electrical stimulation pulses, current or voltage pulse amplitude, pulse rate, pulse width, and other appropriate parameters (such as duration or duty cycle). Such parameters may be applicable to a given therapeutic procedure. It should be noted that an IMD may include multiple therapeutic procedures, which may include at least some parameters that differ from those of each other.

[0029] For example, beta rhythms can be localized via the subthalamic nucleus (STN). It can be helpful to select stimulating electrodes that generate an electric field affecting this oscillating region of the brain; these electrodes, in some examples, may be stimulating electrodes located proximally or optimally relative to that region. The system can detect electrical signals between different electrode combinations and process these signals to generate spectral power characteristics at one or more frequencies. The system can then identify electrode combinations and thus their axial (or horizontal) and circumferential positions associated with spectral power characteristics indicating stronger beta waves. In some examples, the system may recommend electrode combinations associated with stronger beta waves for targeted stimulation of that tissue region. Additionally or alternatively, the system may present clinicians with summary information related to signal quality (such as recommendation levels or recommendation ratings) for different electrodes to allow clinicians to easily select which electrodes they wish to use as stimulating electrodes. Signal quality and / or recommendation ratings may be based on sensed LFPs (and / or characteristics such as spectral power) from different electrode combinations. The sensed LFPs may also be available to the clinician if desired. In other examples, signal quality and / or recommended ratings may be based on other sensed signals, such as eCAP or other evoked responses.

[0030] The system can provide summary information based on the sensed LFP, such as through color representation, graphical representation (e.g., multiple points, sliding scale, etc.), or other representations that distinguish between more highly recommended electrodes and less highly recommended electrodes used as stimulating electrodes. This summary information can be presented on the same screen on which clinicians can select electrodes or program electrodes as stimulating electrodes. In this way, clinicians can select electrode combinations associated with stronger (e.g., larger amplitude spectral power) electrode amplitudes associated with beta waves for subsequent sensing and / or stimulation therapy on the same screen as viewing signal quality indicators (e.g., recommendation ratings) for the stimulating electrodes.

[0031] Each lead may have electrodes positioned at different axial (e.g., longitudinal) locations along the length of the lead. These electrodes may be annular electrodes and / or segmented electrodes residing only around a limited portion of the lead's perimeter. In the case of segmented electrodes residing only around a limited portion of the lead's perimeter, each lead may have electrodes at different circumferential locations (e.g., at different locations around the lead's perimeter) at a given axial location. Thus, two or more segmented electrodes may be positioned at the same axial location along the length of the lead (e.g., at the same level of the lead). As an illustration, a 1-3-3-1 lead would sequentially have an annular electrode at a first nearest axial level, three segmented electrodes at different circumferential locations at a second more distant axial level, three segmented electrodes at different circumferential locations at a third even more distant axial level, and an annular electrode at a fourth most distant axial level. In some examples, the system may group the electrodes together as one polarity (e.g., as a set of cathodes) for use with another electrode of another polarity (e.g., an anode), or vice versa. The system can perform this grouping to balance the impedance between the cathode and anode and improve sensing fidelity. In one example, to sense between an axial horizontal line with a ring electrode and another axial horizontal line with multiple smaller segmented electrodes located at different circumferential positions, the system can group those electrodes at the different circumferential positions together to create a virtual ring electrode (also referred to herein as a segmented electrode in a ring pattern), which improves sensing between the actual ring electrode and the virtual ring electrode. Grouping those electrodes at different circumferential positions together to create a virtual ring electrode is referred to as a ring pattern.

[0032] Sensing electrical signals between different electrodes (including electrodes at different axial and circumferential positions) can provide valuable information about where a particular electrical signal (e.g., signals in the beta band or beta waves, alpha waves, gamma waves, theta waves, and high-frequency oscillations (HFOs)) originates within the tissue. In this way, the system (or clinician) can use this information to determine which electrodes (and / or other stimulation parameter values) should be used to deliver electrical stimulation therapy. The system can provide information representing the sensed electrical signals via a display, allowing clinicians to program stimulation more efficiently and in less time compared to using trial-and-error methods.

[0033] Generally, as part of generating one or more therapeutic procedures, clinicians can select which electrodes to use for stimulation. For example, clinicians can use medical devices to record the sensed electrical signals between different electrode pairs on a single lead (e.g., bipolar sensing) and use a display to show a representation of the recorded bipolar sensed electrical signals. However, generating one or more therapeutic procedures based on the representation of the recorded bipolar sensed electrical signals may not be intuitive for many clinicians. Furthermore, bipolar sensing can be susceptible to electrocardiographic artifacts, which can lead to noisy sensed electrical signals, further complicating the selection of stimulation electrodes.

[0034] Alternatively, as part of the development of one or more therapeutic procedures, clinicians may perform examinations to test each electrode and the effect of stimulation with each electrode on the patient's symptoms. However, this process can take several hours and is uncomfortable for the patient.

[0035] Furthermore, even when using a system that can provide clinicians with unipolar sensing results when determining one or more therapeutic procedures, it may not be possible to provide such results in a way that allows clinicians to easily select the appropriate electrode as the stimulating electrode based on the results.

[0036] According to the technology disclosed herein, a medical device can generate a first screen displaying a signal quality indication based on received signal information for at least one of a plurality of electrodes, for presentation via a user interface. The medical device can obtain selection of one or more of the at least one of the plurality of electrodes as stimulating electrodes via the first screen of the user interface. The medical device can be programmed via telemetry circuitry to provide electrical stimulation according to a stimulation program that defines the stimulating electrodes.

[0037] By providing a screen that includes indications of signal quality (such as a corresponding recommendation rating) and a user interface for selecting an electrode as the stimulating electrode, the technology of this disclosure simplifies the selection of the stimulating electrode and / or reduces the likelihood that clinicians may misremember, mistranscribe, or otherwise misprogram the therapeutic procedure for the IMD. Therefore, the technology of this disclosure can lead to improved patient outcomes (e.g., more effective therapy), reduced clinician and patient time associated with programming the IMD, etc.

[0038] Figure 1 This illustrates a conceptual diagram of an exemplary therapeutic system 10 configured to deliver therapy to a patient 12 to manage the patient's condition. Patient 12 will typically be a human patient. However, in some cases, the therapeutic system 10 may be applied to other mammalian or non-mammal, non-human patients. Figure 1In the example shown, the therapy system 10 includes a medical device programmer 14, an implantable medical device (IMD) 16, a lead extension 18, and one or more leads 20A and 20B (collectively, “leads 20”) with corresponding sets of electrodes 24, 26. The IMD 16 includes a stimulator ( Figure 1 (not shown in the image), the stimulation generator is configured to generate electrical stimulation therapy via electrodes 24 and / or 26 of leads 20A and 20B, respectively, and deliver the electrical stimulation therapy to the STN region of the brain 28 of the patient 12.

[0039] exist Figure 1 In the example shown, the therapy system 10 may be referred to as a deep brain stimulation (DBS) system because the IMD 16 is configured to deliver electrical stimulation therapy directly to the STN within the brain 28. DBS can be used to treat or manage a variety of patient conditions, such as, but not limited to, epileptic seizure pain (e.g., epilepsy), migraines, psychiatric conditions (e.g., major depressive disorder (MDD), bipolar disorder, anxiety disorder, post-traumatic stress disorder, mood disorders, and obsessive-compulsive disorder (OCD)), behavioral disorders, mood disorders, memory disorders, psychomotor disorders, movement disorders (e.g., essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease, or other neurological or psychiatric disorders and injuries of patient 12.

[0040] exist Figure 1 In the example shown, the IMD 16 may be implanted in a subcutaneous pouch in the chest region of patient 12. In other examples, the IMD 16 may be implanted in other regions of patient 12, such as a subcutaneous pouch in the abdomen or buttocks of patient 12, or near the skull of patient 12. The implanted lead extension 18 is coupled to the circuitry in the IMD 16 via proximal electrical contacts connected to electrical terminals (also referred to as the head) in connector block 30. The lead extension 18 may include, for example, distal electrical contacts electrically coupled to the proximal electrical contacts of leads 20A, 20B, which are in turn coupled to corresponding electrodes 24, 26 via conductors within leads 20A, 20B. The proximal electrical contacts of leads 20A and 20B and the distal electrical contacts of lead extension 18 are electrically coupled via conductors within lead extension 18 to the proximal contacts of lead extension 18, and subsequently to the circuitry of IMD 16 via terminals in connector block 30. Lead extension 18 extends from the implantation site of IMD 16 within the chest cavity of patient 12, traverses the neck of patient 12, and passes through the skull of patient 12 to reach brain 28. IMD 16 may be constructed of a biocompatible material resistant to corrosion and degradation by bodily fluids. IMD 16 may include a hermetically sealed housing 34 to substantially encapsulate components such as processors, therapeutic circuitry, and memory.

[0041] exist Figure 1In the example shown, leads 20 are implanted in the right and left hemispheres of brain 28 to deliver electrical stimulation to one or more regions of brain 28, which may be selected based on a number of factors, such as the type of patient condition to be managed by the therapy system 10. Other implantation sites for leads 20 and IMD 16 may be considered. For example, IMD 16 may be implanted on or within the skull 32, or leads 20 may be implanted in the same hemisphere at multiple target tissue sites, or IMD 16 may be connected to a single lead implanted in one or both hemispheres of brain 28.

[0042] Lead 20 can be positioned to deliver electrical stimulation to one or more target tissue sites within brain 28 to manage patient symptoms associated with the condition of patient 12. Lead 20 can be implanted via any suitable technique to position electrodes 24, 26 at desired locations within brain 28, such as through corresponding bone drill holes in the skull of patient 12 or through shared bone drill holes in skull 32. Lead 20 can be placed at any location within brain 28 such that electrodes 24, 26 can provide electrical stimulation to the target therapy delivery site within brain 28 during treatment. For example, in the case of Parkinson's disease, lead 20 can be implanted unilaterally or bilaterally to deliver electrical stimulation to areas within the STN. Target therapy delivery sites not located within brain 28 of patient 12 are also considered.

[0043] Despite Figure 1 The diagram shows lead 20 connected to a common lead extension 18, but in other examples, lead 20 may be connected to IMD 16 via a separate lead extension, or directly to IMD 16. Furthermore, although... Figure 1 Therapeutic system 10 is shown as including two leads 20A and 20B coupled to IMD 16 via lead extension 18, but in some examples, therapeutic system 10 may include one lead or more than two leads.

[0044] exist Figure 1In the example shown, electrodes 24A, 24D, 26A, and 26D of lead 20 are shown as ring electrodes. Ring electrodes are relatively easy to program and can deliver an electric field to any tissue adjacent to lead 20. Electrodes 24B, 24C, 26B, and 26C of lead 20 can have different configurations. For example, electrodes 24B, 24C, 26B, and 26C of lead 20 can each have a complex electrode array geometry capable of generating a shaped electric field. Examples of complex electrode array geometries may include electrode arrays positioned at different axial locations along the length of the lead and at different angular (or circumferential) locations around the periphery (e.g., circumference) of the lead. Complex electrode array geometries may include multiple electrodes (e.g., partially ring-shaped or segmented electrodes), such as electrodes 24B, 24C, 26B, and 26C, each of which includes multiple individually programmable electrodes located at different locations around the periphery of each respective lead 20. Although electrodes 24A, 24D, 26A, and 26D may each be a ring electrode extending completely around the periphery of the lead, any one of these electrodes may be replaced by multiple electrodes located at different positions around the periphery of the lead in other examples. While electrodes 24B, 24C, 26B, and 26C may include multiple electrodes (e.g., partially ring electrodes or segmented electrodes), any one of these electrodes may be replaced by a ring electrode. By using electrodes positioned at different positions around the periphery of the lead, the IMD 16 can deliver directional stimulation as well as electrical stimulation that can be directed from the lead 20 in a specific direction to enhance therapeutic effects and reduce potential adverse side effects due to stimulation of large amounts of tissue. As another example, the electrodes may be pad electrodes, which may be carried on a paddle-shaped or cylindrical lead.

[0045] like Figure 1 As shown in the example, the group of electrodes 24 of lead 20A may include electrodes 24A, 24B, 24C, and 24D, and the group of electrodes 26 of lead 20B may include electrodes 26A, 26B, 26C, and 26D. In some examples, each of electrodes 24 and 26 may be configured to deliver electrical stimulation individually.

[0046] In some examples, the housing 34 of the IMD 16 may include one or more stimulation and / or sensing electrodes. Some or all of these electrodes may be used for both sensing and stimulation, or some electrodes may be dedicated to sensing while others may be dedicated to stimulation. The housing 34 may include conductive material that is exposed to the tissue of the patient 12 when the IMD 16 is implanted in the patient 12, or electrodes may be attached to the housing 34. Thus, in some examples, the electrode combination for stimulation and / or sensing may be formed by a combination of one or more electrodes on one or more leads and one or more electrodes on the housing 34 of the IMD 16, or by a combination of two or more electrodes on one or more leads. In other examples, the leads 20 may have, in addition to, Figure 1 The shape shown is not an elongated cylinder, but has an active or passive tip configuration. For example, lead 20 can be a paddle-shaped lead, a ball-shaped lead, a flexible lead, or any other type of shape that effectively treats patient 12.

[0047] The IMD 16 can deliver electrical stimulation therapy to the brain 28 of patient 12 according to one or more stimulation therapy procedures (also referred to herein as a “set of stimulation parameter values”). The stimulation therapy procedure can be defined by the stimulator of the IMD 16 (…). Figure 1 (Not shown) One or more electrical stimulation parameter values ​​for a therapy generated and delivered from the IMD 16 to the target therapeutic delivery site within the patient 12 via one or more electrodes 24, 26. The electrical stimulation parameters may define one aspect of the electrical stimulation therapy and may include, for example, the voltage or current amplitude of the electrical stimulation signal, the charge level of the electrical stimulation, the frequency of the electrical stimulation signal, the waveform shape, the on / off cycle state (e.g., if the cycle is “off,” the stimulation is always on, and if the cycle is “on,” the stimulation is cyclically on and off), and, in the case of electrical stimulation pulses, the amplitude of the current or voltage pulse, the pulse rate, the pulse width, and other appropriate parameters (such as duration or duty cycle). Additionally, if different electrodes are available for stimulation delivery, the electrode combination may further characterize the therapeutic parameters of the therapeutic procedure, which may define the selected electrodes 24, 26 and their respective polarities. In some examples, a continuous waveform may be used to deliver the stimulation, and the stimulation parameters may define this waveform, but the stimulation will generally be described herein as being defined by stimulation pulses.

[0048] In addition to being configured to deliver therapy to manage patient 12, the therapy system 10 may be configured to sense biocomputational signals or another physiological parameter of patient 12. For example, the IMD 16 may include sensing circuitry configured to sense biocomputational signals in one or more regions of brain 28 via a subgroup of electrodes 24, 26, another set of electrodes, or both. Thus, in some examples, electrodes 24, 26 may be used to deliver electrical stimulation from a stimulation generator to a target site within brain 28 and to sense brain signals within brain 28. However, the IMD 16 may also use a separate set of sensing electrodes to sense biocomputational signals. In some examples, the sensing circuitry of the IMD 16 may sense biocomputational signals via one or more electrodes 24, 26, which are also used to deliver electrical stimulation to brain 28. In other examples, one or more electrodes 24, 26 may be used to sense biocomputational signals, while one or more different electrodes 24, 26 may be used to deliver electrical stimulation.

[0049] Programmer 14 is an external device configured to wirelessly communicate with IMD 16 as needed to provide or retrieve therapy information. Programmer 14 is an external computing device that a user, such as a clinician and / or patient 12, can use to communicate with IMD 16. For example, programmer 14 could be a clinician programmer, which the clinician uses to communicate with IMD 16 and program one or more therapy procedures for IMD 16. Alternatively, programmer 14 could be a patient programmer that allows patient 12 to select programs and / or view and modify therapy parameter values. Clinician programmers may include more programming features than patient programmers. In other words, only clinician programmers may allow for more complex or sensitive tasks to prevent untrained patients from making unintended changes to IMD 16.

[0050] Programmer 14 may be a handheld computing device having a user-visible display and an interface (i.e., a user input mechanism) for providing input to programmer 14. For example, programmer 14 may include a small display screen (e.g., a liquid crystal display (LCD) or a light-emitting diode (LED) display) that presents information to the user. Furthermore, programmer 14 may include a touchscreen display, a keypad, buttons, peripheral pointing devices, voice activation, or another input mechanism that allows the user to navigate and provide input through the user interface of programmer 14. If programmer 14 includes buttons and a keypad, the buttons may be dedicated to performing specific functions (e.g., a power button), and the buttons and keypad may be soft keys whose function changes depending on the segment of the user interface currently viewed by the user, or any combination thereof.

[0051] In other examples, programmer 14 may be a separate application within a larger workstation or another multifunction device, rather than a dedicated computing device. For example, the multifunction device may be a laptop, tablet, workstation, one or more servers, cellular phone, personal digital assistant, or another computing device running an application that enables the computing device to operate as a secure medical device programmer. A wireless adapter coupled to the computing device enables secure communication between the computing device and IMD 16.

[0052] When programmer 14 is configured for use by a clinician, it can be used to transfer programming information to IMD 16. Programming information may include, for example, hardware information such as the type of lead 20, the arrangement of electrodes 24, 26 on the lead 20, the location of the lead 20 within the brain 28, one or more therapeutic procedures defining therapeutic parameter values, treatment windows defining upper and lower amplitude limits for one or more electrodes 24, 26, and any other information that can be programmed into IMD 16. Programmer 14 may also be able to perform functional tests (e.g., measuring the impedance of electrodes 24, 26 of lead 20).

[0053] Clinicians can also generate and store therapy procedures within the IMD 16 using programmer 14. Programmer 14 assists clinicians in creating / identifying therapy procedures by providing a system for identifying potentially beneficial therapy parameter values. For example, during a programming session, a physician can select electrode combinations for delivering therapy to a patient. The physician may have options for creating several therapy procedures. Some procedures may have the same electrode combinations to be used as stimulating electrodes (but with different values ​​for at least one other therapy parameter), and these therapy procedures can be organized into subgroups, each with the same electrode combinations. The physician can select an effective therapy procedure for each subgroup based on a displayed list of sensed LFP signals from the electrode combinations. Clinicians can select therapy procedures to deliver therapy to patient 12 to address symptoms associated with the patient's condition based on a list of electrode combinations providing maximum LFP spectral power displayed on external programmer 14.

[0054] Programmer 14 can also be configured for use by patient 12. When configured as a patient programmer, programmer 14 may have limited functionality (compared to a clinician programmer) to prevent patient 12 from altering critical functions of IMD 16 or applications that may be harmful to patient 12.

[0055] Whether the programmer 14 is configured for use by a clinician or a patient, it can be configured to communicate wirelessly with the IMD 16 and optionally another computing device. For example, the programmer 14 can use radio frequency (RF) and / or inductive telemetry technologies to communicate wirelessly with the IMD 16, including technologies for short-range, mid-range, or long-range communication. The programmer 14 can also communicate with another programmer or computing device via a wired or wireless connection using any of a variety of local wireless communication technologies, such as RF communication according to the 802.11 or Bluetooth specification set, infrared (IR) communication according to the IRDA specification set, or other standard or proprietary telemetry protocols. The programmer 14 can also communicate with other programmers or computing devices via exchangeable removable media, such as disks or optical discs, memory cards, or memory sticks. Furthermore, the programmer 14 can communicate with the IMD 16 and another programmer via remote telemetry technologies known in the art, such as via a personal area network (PAN), local area network (LAN), wide area network (WAN), public switched telephone network (PSTN), or cellular telephone network.

[0056] The therapy system 10 can be implemented to provide chronic stimulation therapy to patient 12 over a period of months or years. However, the therapy system 10 can also be used on a trial basis to evaluate the therapy before full implantation. If implemented interim, some components of the therapy system 10 may not be implanted in patient 12. For example, patient 12 may be fitted with an external medical device, such as a trial stimulator, instead of IMD 16. The external medical device may be coupled to a percutaneous lead or implanted lead via a percutaneous extension. If the trial stimulator instructs the therapy system 10 to provide effective treatment to patient 12, the clinician may implant a chronic stimulator in patient 12 for relatively long-term treatment. In another example, a clinician in the operating room may obtain sensitive recordings during lead placement and before coupling the lead to the IMD. In this example, an external device (e.g., an external electrophysiological system) may be coupled to the medical lead to obtain sensed electrical signals.

[0057] While deep brain stimulation (DBS) can successfully reduce symptoms of some neurological disorders, stimulation can also lead to unwanted side effects (also referred to as adverse effects in this document). Side effects can include incontinence, tingling, loss of balance, paralysis, slurred speech, memory loss, loss of inhibition, and many other neurological problems. Side effects can range from mild to severe. DBS can induce one or more adverse effects by inadvertently delivering electrical stimulation pulses to anatomical areas near the target anatomical region. These anatomical areas may be referred to as areas associated with adverse stimulation. For this reason, clinicians can use therapeutic procedures (or multiple procedures) to program the IMD 16, which defines stimulation parameter values ​​that balance effective therapy and minimize side effects. For example, if the electrode that does sense maximum LFP spectral power is located in an area associated with adverse stimulation, or if delivering the electrode that causes stimulation to maximum LFP spectral power is too high for patient comfort, the clinician can select an electrode to deliver stimulation that does not sense maximum LFP spectral power.

[0058] With the aid of programmer 14 or another computing device, clinicians can select values ​​for therapeutic parameters of the therapy system 10, including the electrode combinations to be used as stimulating electrodes. By selecting specific electrodes and electrode combinations among the electrodes 24, 26 used to deliver electrical stimulation therapy to patient 12, clinicians can modify the electrical stimulation therapy to target one or more specific regions of tissue (e.g., specific anatomical structures) within brain 28 and avoid other regions of tissue within brain 28. Furthermore, by selecting values ​​for other stimulation parameters that define the electrical stimulation signal (e.g., amplitude, pulse width, and pulse frequency), clinicians can generate an effective therapy for patient 12 delivered via the selected electrode subgroup. Parameter values ​​can vary between patients due to physiological diversity, disease variability, and inaccuracies in lead placement.

[0059] During the programming session, the clinician may identify one or more therapeutic procedures that can provide effective treatment to patient 12. Patient 12 may provide feedback to the clinician regarding the efficacy of the specific procedure being evaluated, which may include information about adverse effects of delivering treatment according to the specific procedure. In some examples, patient feedback may be used to determine clinical rating scale scores. Once the clinician has identified one or more procedures that may be beneficial to patient 12, patient 12 may continue the evaluation process and determine which procedure best alleviates patient 12's symptoms or otherwise provides effective treatment to patient 12. Programmer 14 can assist the clinician in creating / identifying therapeutic procedures by providing a structured system of parameters for identifying potentially beneficial therapies.

[0060] In another example, lead 20 may be implanted directly at the target tissue (e.g., in the region with the strongest beta oscillation or the target frequency with the maximum amplitude). In yet another example, lead 20 may be implanted based solely on a single anatomical structure (e.g., placed in the STN). In either of these examples, due to various uncertainties associated with lead placement procedures, the location of the medical lead may differ from the region generating the maximum signal source, resulting in an offset between the target anatomy and the lead location. However, lead 20 does not necessarily need to be offset from the target anatomy, as a lead placed at the target tissue generating the strongest signal provides effective stimulation therapy. Clinicians may choose to implant lead 20 offset from the target tissue, or implant the medical lead directly at or within the target tissue generating the strongest signal.

[0061] When medical leads with a large number of electrodes are used, the time required for clinician evaluation increases. Furthermore, the exploration and programming time required for targeted stimulation on multiple combinations of electrodes also increases. To reduce the time required by both patients and clinicians, in some examples, a representation of recommended levels or grades of electrical signals sensed by multiple electrode combinations can be displayed to the clinician. Based on the sensed signals (e.g., the electrode sensing the maximum signal intensity), the clinician can then select an electrode, or the system can automatically select electrodes to provide electrical stimulation.

[0062] In some examples, the IMD 16 includes sensing circuitry configured to sense electrical signals from a first plurality of electrode combinations, each of the first plurality of electrode combinations including an identical reference electrode of a first lead and at least one different sensing electrode of a second lead. In some examples, one or more of the reference or sensing electrodes may reside on the housing or “shell” of the IMD 16, rather than on the leads. In some examples, the IMD 16 includes processing circuitry configured to record the sensed electrical signals from the first plurality of electrode combinations, provide a representation of the recorded sensed electrical signals, receive instructions from a clinician for two or more selected electrodes, and control the delivery of electrical stimulation via the two or more selected electrodes.

[0063] These sensed electrical signals from the combination of electrodes 24 and / or 26, tailored to a specific patient, can be displayed on a screen or user interface at programmer 14 and / or another computing device. Figure 1(Not shown in the image) Clinicians can select an electrode combination to be used as the stimulating electrode to provide stimulation therapy based on sensed signals from multiple different electrode combinations. For example, clinicians can select electrode combinations including combinations of one or more electrodes in electrode 24 and electrodes on IMD 16 (e.g., shell electrodes or sheath electrodes), combinations of one or more electrodes in electrode 26 and electrodes on IMD 16, combinations of two or more electrodes in electrode 24, combinations of two or more electrodes in electrode 26, or combinations of one or more electrodes in electrode 24 and one or more electrodes in electrode 26 to be used as the stimulating electrode.

[0064] The IMD 16 can be configured to deliver electrical stimulation to a specific patient via an electrode combination selected by a clinician. As an example, when a clinician selects an electrode combination, the clinician can choose a therapy to deliver electrical stimulation to a specific patient via the selected electrode combination. As yet another example, the clinician can input the selected electrode combination into a programmer 14, causing the programmer 14 to automatically select a therapy and configure the IMD 16 to deliver electrical stimulation to a specific patient via the selected electrode combination. As yet another example, the clinician can use a computing device to select an electrode combination, which can be transmitted to a programmable controller 14, which can configure the IMD 16 to deliver electrical stimulation to a specific patient via the clinician-selected electrode combination.

[0065] When a therapy procedure 74 is programmed for the IMD 16 via programmer 14, the clinician can use sensed electrical signals to select the stimulating electrode to be used for a given therapy procedure. To facilitate the selection of stimulating electrodes based on sensed electrical signals, it may be desirable to provide signal quality indications (such as a representation of a recommendation level, e.g., a recommendation rating) for one or more electrodes that may be used as stimulating electrodes on the same programming screen, through which the clinician can select the electrode to be used as the stimulating electrode for a given therapy procedure. These recommendation levels may be based on the sensed electrical signals. By providing signal quality indications (such as a representation of a recommendation rating) for one or more electrodes on the same screen from which the clinician can select the electrode to be the stimulating electrode, the technology of this disclosure reduces the likelihood of clinicians making mistakes in selecting stimulating electrodes, reduces the clinician's cognitive burden, reduces the need for clinicians to take notes while navigating between the screen containing sensed electrical signals and the programming screen, and / or provides improved patient outcomes, as any therapy procedure is more likely to be effective due to the improved ease and ability of the clinician to correctly select the stimulating electrode.

[0066] According to the technology disclosed herein, programmer 14 can generate a first screen displaying an indication of signal quality based on received signal information for at least one of a plurality of electrodes, for presentation via a user interface. Programmer 14 can obtain selection of one or more of the plurality of electrodes as stimulation electrodes via the first screen of the user interface. Programmer 14 can program IMD 16 via telemetry circuitry to provide electrical stimulation according to a stimulation program that defines the stimulation electrodes.

[0067] Figure 2 This is a functional block diagram illustrating the components of example IMD 16. Figure 2 In the example shown, IMD 16 includes processing circuitry 60, memory 62, a stimulus generator 64, sensing circuitry 66, an interface 68, telemetry circuitry 70, and a power supply 72. Memory 62, and other memories described herein, may include any volatile or non-volatile medium, such as random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), flash memory, etc. Memory 62 may store computer-readable instructions that, when executed by processing circuitry 60, cause IMD 16 to perform the various functions described herein.

[0068] exist Figure 2In the example shown, memory 62 may, for example, store therapy programs 74, operating instructions 76, and electrode selection algorithms 78 in a separate memory or a separate region within memory 62. Each stored therapy program 74 defines a specific therapy program based on corresponding values ​​of electrical stimulation parameters, such as the electrode combination to be used as stimulating electrodes, current, or voltage amplitude, and if the stimulation generator 64 generates and delivers stimulation pulses, the therapy program may define values ​​for the pulse width and pulse rate (i.e., frequency) of the stimulation signal. Each stored therapy program 74 may also be referred to as a set of stimulation parameter values. Operating instructions 76 guide the general operation of IMD 16 under the control of processing circuitry 60 and may include instructions for monitoring brain signals in one or more brain regions via electrodes 24, 26 and for delivering electrical stimulation therapy to patient 12. As discussed further in detail below and according to one or more techniques of this disclosure, in some examples, memory 62 may store electrode selection algorithms 78, which may include instructions executable by processing circuitry 60 to select two or more electrodes to sense electrical stimulation. For example, electrode selection algorithm 78 may be executed by processing circuitry 60 to select one or more electrode combinations of electrodes 24 and / or electrodes 26 to sense physiological signals and / or deliver electrical stimulation. In some examples, electrode selection algorithm 78 may be executed by processing circuitry 60 to determine a signal quality indication, such as a recommendation rating, for one or more electrode combinations of electrodes 24 and / or electrodes 26 used to deliver electrical stimulation based on the sensed electrical signals. In some examples, electrode selection algorithm 78 may be executed by processing circuitry 60 to select one or more electrode combinations of electrodes 24 and / or electrodes 26 to deliver electrical stimulation based on input from a user, such as a clinician.

[0069] Under the control of processing circuitry 60, stimulator 64 generates stimulation signals for delivery to patient 12 via a selected combination of stimulation electrodes from electrodes 24, 26. In some examples, stimulator 64 generates stimulation signals based on one or more stored therapeutic procedures 74 and delivers the stimulation signals to brain 28 via a selected combination of stimulation electrodes from electrodes 24, 26. Figure 1 One or more target areas of the brain 28. In some examples, the therapy program 74 is selected at programmer 14 and / or an external computer and transmitted to IMD 16 and stored in memory 62. The target tissue sites within the brain 28 for stimulation signals or other types of therapy and stimulation parameter values ​​may depend on the patient's condition to which the therapy system 10 is implemented. Although stimulation pulses are described, stimulation signals can be of any form, such as continuous-time signals (e.g., sine waves).

[0070] The processor or processing circuitry described in this disclosure, including processing circuitry 60, may include one or more digital signal processors (DSPs), general-purpose microprocessors, application-specific integrated circuits (ASICs), field-programmable arrays (FPGAs), or other equivalent integrated or discrete logic circuits, or combinations thereof. The functionality attributed to the processor described herein may be provided by hardware devices and embodied in software, firmware, hardware, or any combination thereof. Processing circuitry 60 may control stimulation generator 64 according to a therapy program 74 stored in memory 62 to apply specific stimulation parameter values, such as amplitude, pulse width, and pulse frequency, specified by one or more programs.

[0071] exist Figure 2 In the example shown, the group of electrodes 24 of lead 20A includes electrodes 24A–24D, and the group of electrodes 26 of lead 20B includes electrodes 26A–26D. Processing circuitry 60 may interface 68 to apply stimulation signals generated by stimulation generator 64 to the electrode combination of selected stimulation electrodes from electrodes 24 and / or electrodes 26. In some examples, interface 68 may include separate voltage and sink or current and sink coupled to each electrode (i.e., separate voltage and sink and / or current and sink for each of electrodes 24 and / or electrodes 26). In some examples, interface 68 may include switching circuitry that may couple stimulation signals to selected conductors within lead 20, thereby delivering stimulation signals across selected electrodes 24 and / or electrodes 26. In examples where interface 68 includes switching circuitry, the switching circuitry may be a switch array, switch matrix, multiplexer, or any other type of switching circuitry configured to selectively couple stimulation energy to selected electrodes 24 and / or electrodes 26 and selectively sense brain bioelectrical signals using selected electrodes 24 and / or electrodes 26. In some examples, the switching circuitry may be used to couple the sensing electrodes of electrodes 24 and / or 26 to sensing circuitry 66, but not to the stimulating electrodes of electrodes 24 and / or 26 to stimulation generator 64. Therefore, stimulation generator 64 is coupled to electrodes 24 and / or electrodes 26 via interface 68 and conductors within lead 20.

[0072] As discussed above, processing circuitry 60 can control interface 68 to apply stimulation signals generated by stimulation generator 64 to a selected electrode combination of electrodes 24 and / or 26, or to sense electrical signals via sensing circuitry 66. In some examples, the selected electrode combination may be unipolar. For example, one or more electrodes (e.g., one or more cathodes) may be located on lead 20A, and another electrode (e.g., an anode) may be located on lead 20B, and the spacing between the sensing electrodes from the signal source (e.g., 3 mm–9 mm) may be greater than 30 mm. In some examples, the selected electrode combination of electrodes 24 and / or 26 may be unipolar. For example, a selected unipolar combination may include a combination of one electrode of electrode 24 or electrode 26 with an electrode on the housing (i.e., the casing or container) of IMD 16, where one is an anode and the other is a cathode. In some examples, the selected electrode combination of electrodes 24 and / or 26 may be bipolar. As an example, a selected bipolar combination may include two electrodes from electrode 24, where one is an anode and the other is a cathode. As another example, the selected bipolar combination may include two electrodes from electrode 26, one of which is an anode and the other a cathode. As another example, the selected bipolar combination may include an electrode from electrode 24 and an electrode from electrode 26, one of which is an anode and the other a cathode. In some examples, the selected electrode combination of electrode 24 and / or electrode 26 may be multipolar. As an example, the selected multipolar combination may include multiple anodes and / or multiple cathodes selected from electrode 24. As another example, the selected multipolar combination may include multiple anodes and / or multiple cathodes selected from electrode 26. As an example, the selected multipolar combination may include multiple anodes and / or multiple cathodes selected from electrodes 24 and 26.

[0073] Stimulus generator 64 can be a single-channel or multi-channel stimulation generator. Specifically, stimulation generator 64 may be able to deliver 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. However, in some examples, stimulation generator 64 and interface 68 may be configured to deliver multiple channels on a time-interleaved basis. For example, interface 68 may be used to time-divide the output of stimulation generator 64 across different electrode combinations at different times to deliver a program or channel of multiple stimulation energies to patient 12.

[0074] Under the control of processing circuitry 60, sensing circuitry 66 is configured to sense biocomputer signals of patient 12 via a selected subgroup of electrode combinations having one or more electrodes 24 and / or electrodes 26, and at least a portion of the conductive outer casing 34 of IMD 16, an electrode on the outer casing of IMD 16, or another reference. Processing circuitry 60 can control interface 68 to electrically connect sensing circuitry 66 to the selected electrodes 24 and / or electrodes 26. In this way, sensing circuitry 66 can selectively sense biocomputer signals via different combinations of electrodes 24 and / or electrodes 26 (and / or references other than electrodes 24 and / or electrodes 26).

[0075] Although sensing circuit 66 and Figure 2 In some cases, the stimulation generator 64 and processing circuitry 60 are integrated into a common housing 34. However, in other examples, the sensing circuitry 66 is located in a separate outer housing from the outer housing 34 of the IMD 16 and can communicate with the processing circuitry 60 via wired or wireless communication technology.

[0076] Under the control of processing circuitry 60, telemetry switch 70 is configured to support wireless communication between IMD 16 and programmer 14 or another computing device. Processing circuitry 60 of IMD 16 can receive commands from programmer 14 and / or therapy program 74 via telemetry circuitry 70 to execute electrode selection algorithm 78. Therapy program 74 may include indications of selected stimulation electrodes. As an update to the program, processing circuitry 60 of IMD 16 can also receive values ​​of various stimulation parameters such as amplitude and electrode combinations of stimulation electrodes from programmer 14 via telemetry circuitry 70. As discussed above, updates to the therapy program can be stored within the therapy program 74 portion of memory 62. Telemetry circuitry 70 in IMD 16, as well as telemetry circuitry in other devices and systems described herein (such as programmer 14), can communicate via RF communication technology. Furthermore, telemetry circuitry 70 can communicate with programmer 14 via proximal induction interaction between IMD 16 and programmer 14. Therefore, the telemetry circuit 70 can send information to the external programmer 14 on a continuous basis, at periodic intervals, or upon request from the IMD 16 or the programmer 14.

[0077] Power source 72 delivers operating power to the various components of IMD 16. Power source 72 may include a small rechargeable or non-rechargeable battery and power generation circuitry to generate operating power. Recharging is achieved via proximal inductive interaction between an external charger and an inductive charging coil within IMD 16. In some examples, the power requirement may be small enough to allow IMD 16 to utilize patient movement and implement kinetic energy harvesting to trickle charge a rechargeable battery. In other examples, conventional batteries may be used for a limited time.

[0078] Figure 3 This is a functional block diagram illustrating the components of an exemplary medical device programmer. Figure 3 In the example, programmer 14 includes processing circuitry 80, memory 82, telemetry circuitry 84, a user interface 86 with a display 83, and a power supply 88. Processing circuitry 80 controls the user interface 86 and telemetry circuitry 84, and stores and retrieves information and instructions from memory 82. Programmer 14 can be configured to function as a clinician programmer or a patient programmer. Processing circuitry 80 may include any combination of one or more processors, including one or more microprocessors, DSPs, ASICs, FPGAs, or other equivalent integrated or discrete logic circuits. Therefore, processing circuitry 80 may include any suitable structure, whether in hardware, software, firmware, or any combination thereof, to perform the functions attributed to processing circuitry 80 herein.

[0079] Users such as clinicians or patients 12 can interact with programmers 14 through user interface 86. User interface 86 includes a display 83, such as an LCD or LED display or other type of screen, through which processing circuitry 80 presents therapy-related information (e.g., electrode combinations) and sensed electrical signals. Furthermore, user interface 86 may include one or more input devices 90, such as input mechanisms for receiving input from the user. Input devices 90 may include any or more of the following: buttons, keypads (e.g., alphanumeric keypads), peripheral pointing devices (e.g., mouse, trackball, joystick, etc.), a touchscreen of display 83, or another input mechanism that allows the user to navigate and input through screen 89 presented by the processing circuitry 80 of programmer 14. In other examples, user interface 86 may also include audio circuitry for providing auditory notifications, instructions, or other sounds to patient 12, receiving voice commands from patient 12, or both.

[0080] The memory 82 may include instructions for operating the user interface 86 and telemetry circuitry 84, as well as instructions for managing the power supply 88. Figure 3 In the example shown, memory 82 also stores electrode selection algorithm 87. Electrode selection algorithm 87 can be similar to... Figure 2The electrode selection algorithm 78 may be an accompanying algorithm configured to interact with the electrode selection algorithm 78 to perform stimulation electrode selection techniques. The electrode selection algorithm 87 may include instructions executable by the processing circuitry 80 to command the IMD 16 to perform the electrode selection algorithm 78 to test various electrode combinations as described herein and sense the resulting electrical signals. In some examples, the processing circuitry 60 of the IMD 16 may analyze the sensed electrical signals and determine a corresponding signal quality indication (such as a recommendation rating) for the tested electrodes, and transmit the sensed electrical signals and the corresponding signal quality indication to the programmer 14 via telemetry circuitry 70. In some examples, the processing circuitry 60 of the IMD 16 may transmit the sensed electrical signals to the programmer 14 via telemetry circuitry 70, and the processing circuitry 80 may determine the corresponding signal quality indication. In either case, the processing circuitry 60 (e.g., before transmission) and / or the processing circuitry 80 (after reception) may process the sensed electrical signals to remove noise, improve the signal-to-noise ratio, etc.

[0081] In some examples, the processing circuitry 80 executing electrode selection algorithm 87 may invoke screen 89, thereby causing the processing circuitry 80 to load one or more screens from memory 82 onto display 83. For example, the processing circuitry 80 may present electrode selection algorithm 87, which may be executed by the processing circuitry 80 to select two or more electrodes and electrode combinations to sense electrical signals according to the techniques described below.

[0082] In some examples, screen 89 may include a segmented programming screen and a horizontal programming screen for a given lead. For example, the segmented programming screen may depict a corresponding signal quality indication (e.g., a corresponding recommendation rating) for each segmented electrode for a given level or all levels, while the horizontal programming screen may depict a corresponding signal quality indication (e.g., a corresponding recommendation rating) for each level, such as when the segmented electrodes are used as virtual ring electrodes.

[0083] In some examples, processing circuitry 80 may store the sensed electrical signals in result 92. In some examples, processing circuitry 80 may store sensed electrical signals from multiple different programming sessions in result 92 over time. This allows clinicians to review the stored sensed electrical signals over time to monitor or estimate disease progression, lead migration, short circuits, electrode damage, etc. In some examples, result 92 may optionally or additionally be stored on a server (such as a web service server or a hospital server).

[0084] In some examples, processing circuitry 80 may compare sensed electrical signals stored over time (e.g., in result 92) to determine changes in the sensed electrical signals over time. Processing circuitry 80 may provide notification 94 indicating a change in the sensed electrical signals based on the determined change. It should be noted that the sensed electrical signals may be processed and / or stored in their original form before being stored in result 92. Therefore, the stored sensed electrical signals can be considered a representation of the electrical signals. In some examples, to reduce the number of notifications 94 that may be provided by processing circuitry 80, the provision of notification 94 may be further based on a magnitude of change in the representation of the electrical signals that is greater than or equal to a threshold.

[0085] In some examples, the patient 12, the clinician, or another user can otherwise interact with the user interface 86 of the programmer 14 to manually select a combination of therapy procedures or electrodes (e.g., stimulation electrodes), generate a new therapy procedure, modify a therapy procedure, transfer the new procedure to the IMD 16, or any combination thereof.

[0086] Memory 82 may include any volatile or non-volatile memory, such as RAM, ROM, EEPROM, or flash memory. Memory 82 may also include a removable memory portion that can be used to provide memory updates or increase memory capacity. The removable memory may also allow sensitive patient data to be removed before different patients use programmer 14.

[0087] Wireless telemetry in programmer 14 can be achieved through RF communication or near-side sensing interaction between programmer 14 and IMD 16. This wireless communication can be achieved using telemetry circuitry 84. Therefore, telemetry circuitry 84 can be similar to the telemetry circuitry contained within IMD 16. In other examples, programmer 14 may be able to communicate via infrared or directly via a wired connection. In this way, other external devices can communicate with programmer 14 without establishing a secure wireless connection.

[0088] Power supply 88 is configured to deliver operating power to components of programmer 14. Power supply 88 may include a battery and power generation circuitry to generate operating power. In some examples, the battery may be rechargeable to allow for long-term operation. Recharging can be achieved by electrically coupling power supply 88 to a bracket or plug connected to an AC outlet. Alternatively, recharging can be achieved via near-side inductive interaction between an external charger and an inductive charging coil within programmer 14. In other examples, conventional batteries (e.g., nickel-cadmium or lithium-ion batteries) may be used. Furthermore, programmer 14 may be directly coupled to an AC outlet for operation.

[0089] Although various information is shown and described as being stored in the memory 82 of the programmer 14, it should be understood that some or all of this information may alternatively or additionally be stored in the memory 62 of the IMD 16. Furthermore, at least some of the functionality attributable to the processing circuitry 80 of the programmer 14 may alternatively or additionally be attributable to the processing circuitry 60 of the IMD, as discussed below (and vice versa).

[0090] Figure 4 This is a conceptual diagram illustrating an example user interface lead screen 400 representing a display including multiple electrodes, according to one or more aspects of this disclosure. Screen 400 may be a screen of screen 89. Processing circuitry 80 enables display 83 to display or present screen 400 on display 83.

[0091] Screen 400 includes a representation of leads 402. The representation of leads 402 includes representations of a plurality of electrodes 404 labeled 0, 1a-1c, 2a-2c, and 3. The representations of electrodes labeled 1a-1c and 2a-2c may be shown separately from the representation of leads 402 as shown (representation 406) (e.g., in addition to or instead of showing such leads in the representation of leads 402), because electrodes labeled 1a-1c and 2a-2c may include segmented electrodes, and some of the segmented electrodes 1a-1c and 2a-2c may be located on the back side of the leads represented by the representation of leads 402, and are therefore not visible in the representation of leads 402.

[0092] Screen 400 also includes a description 410 of the type of therapeutic procedure and the name and / or ID of the patient for whom the therapeutic procedure is being generated. Screen 400 may also include an interface 412 from which one of several screens can be selected. For example, screen 400 includes a lead, annotation, and brain sense. Annotation can be selected to allow the system to provide a screen on which a user (e.g., a clinician) can create and / or view annotations related to the therapeutic procedure. Brain sense can be selected to allow the system to provide viewing of test results (such as sensed electrical signals) and / or send commands to IMD 16 to execute electrode selection algorithm 78 to perform tests to capture sensed electrical signals.

[0093] Screen 400 also includes a description 420 indicating which lead (left subthalamic nucleus) is represented by the lead 402 and which therapy procedure (procedure 1) the user is currently setting or viewing. Screen 400 may also include an interface, such as icon 430, that the user can select to perform actions, such as opening a drop-down menu with one or more selectable options to, for example, view various data associated with the electrodes.

[0094] Figure 5This illustrates, according to one or more aspects of this disclosure, a drop-down menu. Figure 4 A conceptual diagram of an example user interface lead screen. Screen 500 can be a screen within screen 89. Processing circuitry 80 enables display 83 to display screen 500 on display 83. For example, when the user selects... Figure 4 When icon 430 is displayed, processing circuitry 80 enables display 83 to show screen 500. On screen 500, drop-down menu 502 appears. For example, drop-down menu 502 may include an interface for selecting a level to view signal quality indicators (such as the level of recommended test results) (e.g., viewing unipolar results), and an interface for viewing more detailed test results (such as graphs of sensed electrical signals) (e.g., brain sensing surveys, which may include details related to the sensed signal, graphs of signal power versus frequency for each electrode, etc.), and / or for sending commands to IMD 16 to execute electrode selection algorithm 78 to perform tests to capture the sensed electrical signals. In some examples, if no test has been performed, the interface for selecting a level to view recommended test results may not be operable or displayed. In some examples, if no test has been performed, the interface for selecting the level to view recommended test results may be operable to provide recommendations for tests that the user has already performed, and may also provide an interface for directly selecting options for performing tests, thereby enabling the processing circuitry 80 to send commands to the IMD 16 via the telemetry circuitry 84 to execute the electrode selection algorithm 78 and perform tests, such as unipolar sensing tests.

[0095] Figure 6 This is a conceptual diagram illustrating an example user interface result screen that displays leads of multiple electrodes and corresponding recommended levels for some of the electrodes, according to one or more aspects of this disclosure. Screen 600 may be a screen within screen 89 and includes screen 500, with sub-window 610 overlaying screen 500. Processing circuitry 80 enables display 83 to display screen 600 on display 83. For example, when a user selects... Figure 5 When viewing the unipolar results, the processing circuit 80 can cause the display 83 to display screen 600 on the display 83. Screen 600 can display the recommended level 602 for each segmented electrode in segments 1a-1c and 2a-2c.

[0096] The screen 600 may also include a selected frequency (e.g., 23.82 Hz), which may represent the frequency of the sensed electrical signal on which the recommended level is based.

[0097] As in Figure 6As can be seen in example screen 600, the recommendation level can be displayed graphically (shown here as circles). For example, the more filled circles that appear, the higher the recommendation level. In some examples, the recommendation level can be represented by color. For example, circles can be filled with the color representing the recommendation rating to further distinguish between higher and lower recommendation ratings. For example, if all three circles are to be filled for highly recommended segmented electrodes 1a and 1b, these circles can be filled with green to indicate a high recommendation, while the two circles for segmented electrodes 1c, 2a, and 2b can be filled with a different color to indicate a moderate recommendation, and one circle for segmented electrode 2c can be filled with yet another color to indicate a low recommendation. In some examples, the entire representation of the segmented electrodes can be colored to represent the corresponding recommendation rating. In other examples, indicators of different shapes, colors, or numbers can be used for the electrodes.

[0098] Figure 7 This is a conceptual diagram illustrating another example user interface result screen that displays leads comprising multiple electrodes and corresponding recommended levels for some of the electrodes, according to one or more aspects of this disclosure. Screen 700 may be a screen within screen 89 and includes screen 500, with sub-window 710 overlaying screen 500. Processing circuitry 80 may cause display 83 to display screen 700 on display 83. For example, if a user selects “Level” from screen 600, processing circuitry 80 may cause display 83 to display screen 700 on display 83. Screen 700 may differ from screen 600 in that a representation of any segmented electrode may be displayed as a virtual ring electrode constituting a single “horizontal” or axial position along the leads. Recommended level 702 may be displayed on screen 700 in a manner similar to that described with respect to screen 600; however, screen 600 may not display a representation of each segmented electrode in the segmented electrodes, since any segmented electrode represented in screen 700 acts as a virtual ring electrode.

[0099] Figure 8 This illustrates, according to one or more aspects of this disclosure, instructions for user input. Figure 6A conceptual diagram of the example user interface result screen is provided. Screen 800 may be a screen within screen 89 and includes screen 500, with sub-window 810 overlaying screen 500. Processing circuitry 80 causes display 83 to display screen 800 on display 83. For example, if the user selects "Segmentation" from screen 700, processing circuitry 80 causes display 83 to display screen 800 on display 83, which shows each segmented electrode at each axial level of the lead. On screen 800 (which may be the same as or similar to screen 600), the user can select all segmented electrodes 1a-1c and electrode 0, or a subset of those electrodes, as stimulating electrodes. It should be noted that the user can select any combination of electrodes as stimulating electrodes. The recommended level 802, represented in screen 800, guides the user in selecting which electrodes should be stimulating electrodes. In this manner, the processing circuit 80 can present a first screen (e.g., screen 800) via a user interface 86, which presents a representation of a plurality of electrodes and a representation of a corresponding recommended rating for at least one of the plurality of electrodes, and obtain selection of one or more of the plurality of electrodes as stimulation electrodes via the first screen of the user interface.

[0100] Figure 9 This illustrates, according to one or more aspects of this disclosure, the selection of stimulation electrodes via user input. Figure 6 and Figure 8 A conceptual diagram of an example user interface result screen. Screen 900 may be a screen within screen 89 and includes screen 900, with sub-window 910 overlaying screen 900. Processing circuitry 80 may cause display 83 to display screen 900 on display 83. For example, when a user selects all segmented electrodes 1a-1c and electrode 0, processing circuitry 80 may cause display 83 to display screen 900 on display 83. Screen 900 may include indication 902 indicating which electrodes have been selected as stimulation electrodes, these stimulation electrodes may be some or all of the segmented electrodes at the same axial level of the leads. In some examples, the user may select which electrode will be used as an anode or cathode, and indication 902 may differ based on whether a particular electrode is an anode or cathode. Screen 900 may include buttons for deselecting selected electrodes and buttons for updating or saving selected electrodes as stimulation electrodes. It should be noted that screen 900 may function similarly to screens 700 and 800, thereby facilitating the user's selection of stimulation electrodes while viewing a representation of recommended level 902.

[0101] Figure 10This is a conceptual diagram of an example user interface lead screen illustrating one or more aspects of this disclosure, including leads of selected electrodes as stimulating electrodes and providing input of other parameters associated with a therapeutic procedure. Screen 1000 may be a screen of screen 89. Processing circuitry 80 may cause display 83 to display screen 1000 on display 83. For example, when a user selects “Update” on screen 900, processing circuitry 80 may cause display 83 to remove screen 900 and display screen 1000 on display 83. Screen 1000 may include a representation of lead 1002 (which may correspond to a representation of lead 402) and may include an indication 1004 of which electrodes have been selected as stimulating electrodes. Indication 1004 may be similar to indication 902. Screen 1000 may include an interface 1006 for inputting other parameters (such as amplitude, pulse width, and frequency) for a particular therapeutic procedure (e.g., procedure 1).

[0102] Figure 11 This is a conceptual diagram illustrating an example screen including power spectral density according to one or more techniques of this disclosure. For example, if a user selects brain sensing from screen 400, processing circuitry 80 may provide the user with one or more screens (or an interface for selecting one or more screens from it), such as screen 1310 on display 83. Screen 1310 includes a representation of leads in block 1300, wherein the bottom electrode of the leads acts as a reference electrode. Graph 1302 shows the raw power spectral density of an electrical signal sensed using monopolar sensing on a segment-by-segment basis. Graph 1304 shows the raw power spectral density of an electrical signal sensed using monopolar sensing by a ring electrode and any segmented electrodes in a ring pattern. Graph 1306 shows the denoised power spectral density of an electrical signal sensed using monopolar sensing on a segment-by-segment basis. Graph 1308 shows the denoised power spectral density of an electrical signal sensed using monopolar sensing by a ring electrode and any segmented electrodes in a ring pattern (e.g., the processed sensed electrical signal). As can be seen, screen 1310 includes a great deal of information. For each potential reference electrode, a similar screen may exist. Therefore, if the screen used to select the electrode as the stimulation electrode is the same as the screen used for this purpose (e.g., ...), Figures 6 to 9If screens 600, 700, 800, or 900 lack indications of signal quality (such as recommended levels), the sheer volume of information associated with the sensed electrical signal may make it difficult for clinicians to select an electrode as the stimulating electrode based on information from each of screens, including screen 1310, without error or extensive note-taking. In cases involving numerous and / or segmented electrodes, clinicians may be unable to analyze all screens containing information such as screen 1310, and may not be able to retain the information and / or results of their analysis within these screens as they navigate to them to select an electrode as the stimulating electrode. Therefore, it may be desirable to provide screens, such as screens 600, 700, 800, and 900, that include indications of signal quality (such as recommended levels) and allow clinicians to select electrodes as stimulating electrodes from the same screen.

[0103] Figure 12 This is a flowchart illustrating an example technique for selecting electrode combinations to deliver electrical stimulation, based on one or more techniques according to this disclosure. While primarily concerning... Figure 3 The processing circuit 80 is described, but it should be noted that... Figure 12 The technology can be practiced by processing circuitry from any device or combination of devices capable of performing such technology.

[0104] Processing circuit 80 can generate a first screen displaying a representation of multiple electrodes and a signal quality indication based on received signal information for at least one of the multiple electrodes, for presentation via a user interface (1200). For example, processing circuit 80 can determine for electrode 24 or 26 ( Figure 1 The processing circuit 80 can generate a corresponding recommendation rating for any electrode in the screen 600, 700, 800, or 900. Screen 600, 700, 800, or 900 can include a representation of the corresponding recommendation rating (e.g., recommendation levels 602, 702, 802, 902).

[0105] Processing circuitry 80 can obtain selection (1202) of one or more of at least one of a plurality of electrodes as stimulating electrodes via a first screen of a user interface. For example, a clinician can select one or more of electrodes 24 or 26 as stimulating electrodes via screens 600, 700, 800, or 900. Processing circuitry 80 can obtain the clinician's selection. Obtaining the selection via the first screen is intended to include obtaining the selection from the clinician's interaction with the first screen through any of the input devices 90, and not just through interaction with a touchscreen.

[0106] Processing circuitry 80 can program the IMD via telemetry circuitry to provide electrical stimulation according to a stimulation program that defines the stimulating electrodes (1204). For example, processing circuitry 80 can transmit a therapy program from therapy program 74 to IMD 16 via telemetry circuitry 84. The therapy program may include identification of the stimulating electrodes.

[0107] In some examples, the plurality of electrodes (e.g., electrodes 24 and / or 26) include at least one segmented electrode disposed around a portion of the periphery of the lead. In some examples, the signal quality indication includes a corresponding recommended rating for at least one segmented electrode. In some examples, the signal quality indication includes a recommended rating for a ring electrode or a dummy ring electrode comprising a plurality of segmented electrodes disposed at the same axial location on the lead.

[0108] In some examples, signal quality indications (e.g., representations of corresponding recommended levels 602, 702, 802, or 902) include at least one of color or graphical representations. In some examples, the user interface 86 also includes an interface operable to allow a user to provide instructions for performing tests on the implantable medical device (e.g., interface 412 or drop-down menu 502). In such examples, processing circuitry 80 is also configured to: obtain instructions from the user for performing tests; and obtain test results 92 via telemetry circuitry 84. In some examples, processing circuitry 80 is configured to perform tests to control the IMD 16 to sense electrical signals from a plurality of electrode combinations, each of which includes the same reference electrode among the plurality of electrodes and at least one different sensing electrode among the plurality of electrodes. In some examples, the electrical signals include unipolar local field potentials (LFPs). In some examples, the test result 92 includes a representation of electrical signals (e.g., graphs 1302, 1304, 1306, and 1308), and the processing circuitry 80 is further configured to generate a signal quality indication based on the representation of the electrical signals. In some examples, the signal quality indication is based on the signal strength of one or more of the electrical signals. In some examples, the user interface 86 also includes a screen (e.g., screen 1310) containing a representation of the electrical signals.

[0109] In some examples, the user interface 86 also includes a representation of at least one of the amplitude, pulse width, or frequency associated with the stimulation procedure (e.g., interface 1006), and the processing circuitry 86 is further configured to obtain, via the user interface 86, at least one of the amplitude, pulse width, or frequency associated with the stimulation procedure from the user. In some examples, the processing circuitry 80 is further configured to store the representation of the electrical signal in memory (e.g., in result 92). In some examples, the processing circuitry 80 is further configured to present multiple representations of the electrical signal stored over time via the user interface 86 (e.g., result 92). In some examples, the processing circuitry 80 is further configured to determine a change in the representation of the electrical signal over time, and based on the determination of the change in the representation of the electrical signal, control the user interface 86 to present a notification 94 indicating the change in the representation of the electrical signal. In some examples, providing the notification may be further based on the magnitude of the change in the representation of the electrical signal being greater than or equal to a threshold.

[0110] In some examples, system 10 and / or programmer 14 include display 83. In some examples, system 10 includes IMD 16. In some examples, IMD 16 includes stimulation generator 64, and wherein IMD 16 provides electrical stimulation via stimulation generator 64 and stimulation electrodes according to a stimulation program (e.g., therapy program 74).

[0111] As described herein, systems employing directional brain sensing can reduce the time required to identify combinations of electrodes used to sense desired signals and / or deliver electrical stimulation therapy. In this way, the systems described herein can improve clinician efficiency and therapeutic efficacy. Furthermore, by providing a representation of signal quality indications (such as corresponding recommended levels) for the electrodes on the same screen through which clinicians can select the electrodes to be used as stimulation electrodes, the systems and techniques described herein can reduce the likelihood of clinicians making errors during programming, reduce the need for clinicians to take notes during testing and programming sessions, reduce the cognitive burden on clinicians attempting to remember large amounts of results while navigating the programming screen, and / or reduce the amount of time required to program the therapy. These techniques are indeed advantageous when considering the use of an increased number of electrodes in implantable leads (e.g., leads with electrodes positioned at different locations around the periphery of the lead and at different locations along the length of the lead). Therefore, the techniques and systems described herein can further enable the use of more electrodes, which can improve targeting to desired tissues (e.g., specific brain regions associated with disease, symptoms, or therapy) while reducing the time required for clinicians to program. The techniques and systems described herein can also further enable the use of different electrode configurations and geometries.

[0112] The techniques described in this disclosure may be performed, at least in part, in hardware, software, firmware, or any combination thereof, including those attributable to the IMD 16, programmer 14, or various constituent components. For example, aspects of these techniques may be implemented within one or more processors, including one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuits, and any combination of such components embodied in a programmer, such as a clinician or patient programmer, medical device, or other device.

[0113] In one or more examples, the functionality described in this disclosure may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functionality may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. The computer-readable medium may include a computer-readable storage medium forming a tangible, non-transitory medium. The instructions may be executed by one or more processors, such as one or more DSPs, ASICs, FPGAs, general-purpose microprocessors, or other equivalent integrated or discrete logic circuits. Therefore, the term "processor" as used herein may refer to one or more of the foregoing structures or any other structures suitable for implementing the techniques described herein.

[0114] In addition, in some aspects, the functionality described herein may be provided within dedicated hardware and / or software modules. Describing different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be implemented by separate hardware or software components. Rather, the functionality associated with one or more modules or units may be performed by separate hardware or software components, or integrated into common or separate hardware or software components. Furthermore, this technology may be fully implemented in one or more circuit or logic elements. The technology disclosed herein may be implemented in a variety of devices or apparatuses, including IMDs, external programmers, combinations of IMDs and external programmers, integrated circuits (ICs), or a set of ICs and / or discrete circuits residing in IMDs and / or external programmers.

[0115] This disclosure includes the following non-limiting embodiments.

[0116] Example 1. A medical device system comprising: a memory configured to store a user interface; telemetry circuitry; and processing circuitry coupled to the memory and the telemetry circuitry, the processing circuitry being configured to: generate a first screen presenting a representation of a plurality of electrodes and a signal quality indication based on received signal information for at least one of the plurality of electrodes, for presentation via the user interface; obtain selection of one or more of the at least one of the plurality of electrodes as stimulating electrodes via the first screen of the user interface; and program an implantable medical device (IMD) via the telemetry circuitry to provide electrical stimulation according to a stimulation program defining the stimulating electrodes.

[0117] Example 2. The medical device system according to Example 1, wherein the plurality of electrodes includes at least one segmented electrode disposed around a portion of the lead wire.

[0118] Example 3. The medical device system according to Example 2, wherein the signal quality indication includes a corresponding recommended rating for the at least one segmented electrode.

[0119] Example 4. The medical device system according to Example 2, wherein the signal quality indication includes a recommended rating for a ring electrode or a virtual ring electrode comprising multiple segmented electrodes disposed at the same axial position on the lead.

[0120] Example 5. A medical device system according to any one of Examples 1 to 4, wherein the signal quality indication includes at least one of color or graphic representation.

[0121] Example 6. A medical device system according to any one of Examples 1 to 5, wherein the user interface further includes an interface operable to allow a user to provide instructions for performing a test on the implantable medical device, and wherein the processing circuitry is further configured to: obtain the instructions for performing the test from the user; and obtain the result of the test via the telemetry circuitry.

[0122] Example 7. A medical device system according to Example 6, wherein the processing circuit is configured to perform the test to control the IMD to sense electrical signals from a plurality of electrode combinations, each of the plurality of electrode combinations including the same reference electrode among the plurality of electrodes and at least one different sensing electrode among the plurality of electrodes.

[0123] Example 8. The medical device system according to Example 7, wherein the electrical signal includes a local field potential (LFP).

[0124] Example 9. A medical device system according to Example 7 or Example 8, wherein the result of the test includes a representation of the electrical signal, and wherein the processing circuitry is further configured to generate the signal quality indication based on the representation of the electrical signal.

[0125] Example 10. The medical device system according to Example 9, wherein the signal quality indication is based on the signal strength of one or more of the electrical signals.

[0126] Example 11. A medical device system according to Example 9 or Example 10, wherein the user interface further includes a screen containing the representation of the electrical signal.

[0127] Example 12. A medical device system according to any one of Examples 1 to 11, wherein the user interface further includes a representation of at least one of amplitude, pulse width, or frequency associated with the stimulation program, and wherein the processing circuitry is further configured to obtain, via the user interface, at least one of the amplitude, pulse width, or frequency associated with the stimulation program from the user.

[0128] Example 13. A medical device system according to any one of Examples 1 to 12, wherein the processing circuit is further configured to store the representation of the electrical signal in the memory.

[0129] Example 14. The medical device system according to Example 13, wherein the processing circuitry is further configured to present, via the user interface, a plurality of representations of the electrical signals stored over time.

[0130] Example 15. The medical device system according to Example 14, wherein the processing circuitry is further configured to: determine a change in the representation of the electrical signal over time; and control the user interface to present a notification indicating the change in the representation of the electrical signal based on the determination of the change in the representation of the electrical signal.

[0131] Example 16. The medical device system according to any one of Examples 1 to 15, wherein the medical device system further includes a display.

[0132] Example 17. The medical device system according to any one of Examples 1 to 16, wherein the medical device system further includes the IMD.

[0133] Example 18. A medical device system according to any one of Examples 1 to 17, wherein the IMD includes a stimulation circuit, and wherein the IMD provides the electrical stimulation via the stimulation circuit and the stimulation electrodes according to the stimulation program.

[0134] Example 19. A method comprising: generating a first screen presenting a representation of a plurality of electrodes and a signal quality indication based on received signal information for at least one of the plurality of electrodes, for presentation via a user interface; obtaining selection of one or more of the at least one of the plurality of electrodes as stimulating electrodes via the first screen of the user interface; and programming an implantable medical device (IMD) via telemetry circuitry to provide electrical stimulation according to a stimulation program defining the stimulating electrodes.

[0135] Example 20. The method according to Example 19, wherein the plurality of electrodes includes at least one segmented electrode disposed around a portion of the lead wire.

[0136] Example 21. The method according to Example 20, wherein the signal quality indication includes a corresponding recommended rating for the at least one segmented electrode.

[0137] Example 22. The method according to Example 19, wherein the signal quality indication includes a recommended rating for a ring electrode or a virtual ring electrode comprising multiple segmented electrodes disposed at the same axial position on the lead.

[0138] Example 23. The method according to any one of Examples 19 to 22, wherein the signal quality indication includes at least one of color or graphic representation.

[0139] Example 24. A non-transitory computer-readable storage medium storing instructions that, when executed, cause processing circuitry to: generate a first screen presenting a representation of a plurality of electrodes and a signal quality indication based on received signal information for at least one of the plurality of electrodes, for presentation via a user interface; obtain selection of one or more of the at least one of the plurality of electrodes as stimulating electrodes via the first screen of the user interface; and program an implantable medical device (IMD) via telemetry circuitry to provide electrical stimulation according to a stimulation program defining the stimulating electrodes.

[0140] Various embodiments of this disclosure have been described. These and other embodiments are within the scope of the appended claims.

Claims

1. A medical device system, the medical device system comprising: A memory configured to store a user interface; Telemetry circuit; and Processing circuitry, coupled to the memory and the telemetry circuitry, is configured to: A first screen is generated that presents a representation of multiple electrodes and a signal quality indication based on received signal information for at least one of the multiple electrodes, for presentation via the user interface; The selection of one or more of the at least one of the plurality of electrodes as stimulation electrodes is obtained via the first screen of the user interface; as well as The implantable medical device (IMD) is programmed via the telemetry circuit to provide electrical stimulation according to a stimulation program that defines the stimulation electrodes.

2. The medical device system of claim 1, wherein the plurality of electrodes includes at least one segmented electrode disposed around a portion of the lead wire.

3. The medical device system of claim 2, wherein the signal quality indication includes a corresponding recommended rating for the at least one segmented electrode.

4. The medical device system of claim 2, wherein the signal quality indication includes a recommended rating for a ring electrode or for a virtual ring electrode comprising a plurality of segmented electrodes disposed at the same axial position on the lead.

5. The medical device system according to any one of claims 1 to 4, wherein the signal quality indicator has at least one of color or graphic representation.

6. The medical device system according to any one of claims 1 to 5, wherein the user interface further comprises an interface operable to allow a user to provide instructions for performing tests on the implantable medical device, and wherein the processing circuitry is further configured to: Obtain the instruction from the user for performing the test; and The test results are obtained via the telemetry circuit.

7. The medical device system of claim 6, wherein the processing circuitry is configured to perform the test to control the IMD to sense electrical signals from a plurality of electrode combinations, each of the plurality of electrode combinations including the same reference electrode among a plurality of electrodes and at least one different sensing electrode among the plurality of electrodes.

8. The medical device system of claim 7, wherein the electrical signal includes a local field potential (LFP).

9. The medical device system of claim 7 or claim 8, wherein the result of the test includes a representation of the electrical signal, and wherein the processing circuitry is further configured to generate the signal quality indication based on the representation of the electrical signal.

10. The medical device system of claim 9, wherein the signal quality indication is based on the signal strength of one or more of the electrical signals.

11. The medical device system of any one of claims 1 to 10, wherein the user interface further includes a representation of at least one of amplitude, pulse width, or frequency associated with the stimulation procedure, and wherein the processing circuitry is further configured to obtain, via the user interface, at least one of the amplitude, pulse width, or frequency associated with the stimulation procedure from the user.

12. The medical device system according to any one of claims 1 to 11, wherein the processing circuit is further configured to: The representation of the electrical signal is stored in the memory; and The user interface presents multiple representations of the electrical signals stored over time.

13. The medical device system of claim 12, wherein the processing circuit is further configured to: Determine the change in the representation of the electrical signal over time; and The user interface is controlled to display a notification indicating the change in the representation of the electrical signal based on the determination of the change in the representation of the electrical signal.

14. A method comprising: A first screen is generated that presents a representation of multiple electrodes and a signal quality indication based on received signal information for at least one of the multiple electrodes, for presentation via a user interface; The selection of one or more of the at least one of the plurality of electrodes as stimulation electrodes is obtained via the first screen of the user interface; as well as An implantable medical device (IMD) is programmed via telemetry circuitry to provide electrical stimulation according to a stimulation program that defines the stimulation electrodes.

15. A computer-readable storage medium storing instructions that, when executed, cause processing circuitry to: A first screen is generated that presents a representation of multiple electrodes and a signal quality indication based on received signal information for at least one of the multiple electrodes, for presentation via a user interface; The selection of one or more of the at least one of the plurality of electrodes as stimulation electrodes is obtained via the first screen of the user interface; as well as An implantable medical device (IMD) is programmed via telemetry circuitry to provide electrical stimulation according to a stimulation program that defines the stimulation electrodes.

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