User interface electrode sensing and imaging visualization

Abstract

An example system includes a memory configured to store instructions defining a user interface, telemetry circuitry, and processing circuitry coupled to the memory and the telemetry circuitry. In one example, the processing circuitry is configured to receive signal information representing one or more signals sensed via at least one electrode of a plurality of electrodes of an implantable medical device (HMD), generate, for presentation via a screen of the user interface, a representation of the one or more signals sensed via the at least one electrode, and generate, for presentation via the screen of the user interface, a representation of an anatomical structure of the patient with respect to a representation of at least some electrodes of the plurality of electrodes.

Description

Docket No.: A0013320W001 / 1123-866W001USER INTERFACE ELECTRODE SENSING AND IMAGING VISUALIZATION

[0001] This application is a PCT application claiming the benefit of, and priority to, U.S. Provisional Patent Application No. 63 / 700,585, filed September 27, 2024, the entire contents of which is incorporated herein by reference.TECHNICAL FIELD

[0002] The disclosure relates to medical devices, and more specifically, visualization and programming techniques for electrical stimulation.BACKGROUND

[0003] Implantable medical devices, such as electrical stimulators or therapeutic agent delivery devices, have been proposed for use in different therapeutic applications, such as deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, functional electrical stimulation or delivery of pharmaceutical agents, insulin, pain relieving agents or anti-inflammatory agents to a target tissue site within a patient. In some therapy systems, an implantable electrical stimulator delivers electrical therapy to a target tissue site within a patient via electrodes, that may be deployed by medical leads and / or on a housing of the electrical stimulator, or both. In some therapy systems, therapy may be delivered via particular combinations of the electrodes carried by leads and / or by the housing of the electrical stimulator.SUMMARY

[0004] In general, this disclosure is directed to devices, systems, and methods for receiving and presenting information relating to programming of electrical stimulation therapy parameters, including selection of one or more electrodes or combination of electrodes for electrical stimulation therapy based on sensed signals. Sensed signals may include intrinsic bioelectric signals such as LFP (local field potential) signals, or signals evoked by delivered stimulus such as evoked compound action potential (ECAP) signals or evoked resonant neural response (ERNA) signals.

[0005] In some examples, a system may be configured to generate, for presentation via a user interface, information relating to sensed signals (LFP, ECAP, etc.) for electrodes (e.g., electrode segments and / or electrode levels). This information may include an indication of signal quality (e.g., one or more characteristics of the signals such as absolute LFP magnitudes, relative LFPDocket No.: A0013320W001 / 1123-866W001 magnitudes compared to other electrodes, presence of an artifact, presence of noise, etc.), an analysis of one or more frequency bands suppressed or detected in an LFP signal, or other information. In addition, the user interface may display the sensed signal information on the same screen as an anatomical region of the patient, a representation of an implanted lead and / or electrodes, and / or other information regarding therapy. In this manner, the user interface may display the spatial relationships between the implanted electrodes and anatomical structures in addition to information regarding signals sensed by one or more electrodes. The user interface may also show volume of activation or other shapes corresponding to the stimulation deliverable by the electrodes. The user can then make more informed decisions when selecting electrodes, amplitude, or other stimulation parameters in order to provide stimulation to the target anatomy while reducing trial-and-error.

[0006] In one example, a system includes a memory configured to store instructions defining a user interface, processing circuitry coupled to the memory and the telemetry circuitry, the processing circuitry being configured to receive signal information representing one or more signals sensed via at least one electrode of a plurality of electrodes of an implantable medical device (IMD), generate, for presentation via a screen of the user interface, a representation of the one or more signals sensed via the at least one electrode; and generate, for presentation via the screen of the user interface, a representation of an anatomical structure of the patient with respect to a representation of at least some electrodes of the plurality of electrodes.

[0007] In another example, a method includes receiving, by processing circuitry, signal information representing one or more signals sensed via at least one electrode of a plurality of electrodes of an implantable medical device (IMD), generating, by the processing circuitry, for presentation via a screen of the user interface, a representation of the one or more signals sensed via the at least one electrode, and generating, by the processing circuitry, for presentation via the screen of the user interface, a representation of an anatomical structure of the patient with respect to a representation of at least some electrodes of the plurality of electrodes.

[0008] In another example, a computer-readable medium includes instructions that, when executed, control processing circuitry to receive signal information representing one or more signals sensed via at least one electrode of a plurality of electrodes of an implantable medical device (IMD), generate, for presentation via a screen of the user interface, a representation of the one or more signals sensed via the at least one electrode, and generate, for presentation via the screen of the user interface, a representation of an anatomical structure of the patient with respect to a representation of at least some electrodes of the plurality of electrodes.Docket No.: A0013320W001 / 1123-866W001

[0009] The summary is intended to provide an overview of the subject matter described in this disclosure. It is not intended to provide an exclusive or exhaustive explanation of the systems, device, and methods described in detail within the accompanying drawings and description below. Further details of one or more examples of this disclosure are set forth in the accompanying drawings and in the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0010] FIG. 1 is a conceptual diagram illustrating an example deep brain stimulation (DBS) system configured to deliver electrical stimulation therapy to a tissue site within a brain of a patient in accordance with one or more aspects of this disclosure.

[0011] FIG. 2 is functional block diagram illustrating components of an example medical device in accordance with one or more aspects of this disclosure.

[0012] FIG. 3 is a functional block diagram illustrating components of an example medical device programmer in accordance with one or more aspects of this disclosure.

[0013] FIGS. 4 and 5 are conceptual diagrams illustrating an example user interface that includes a screen displaying a representation of a lead, anatomical structure, and representations of sensed signal quality.

[0014] FIGS. 6 and 7 are conceptual diagrams illustrating an example user interface that includes a screen displaying a representation of a lead, anatomical structure, and representations of sensed signal quality.

[0015] FIGS. 8 and 9 are conceptual diagrams illustrating an example user interface that includes a screen displaying a representation of a lead, anatomical structure, volume of activation, and representations of sensed signal quality.

[0016] FIG. 10 is a conceptual diagram illustrating an example user interface that includes a screen displaying representations of electrical signals sensed by electrode combinations and stimulation parameter values.

[0017] FIGS. 11 and 12 are conceptual diagrams illustrating examples visualizations of anatomical structures and sensing quality from respective electrode combinations.

[0018] FIG. 13 is a conceptual diagram illustrating example visualizations of anatomical structures and target stimulation areas based on sensed signals and volume of neural activation (VNA).

[0019] FIGS. 14A and 14B are graphs of stimulation characteristics based on stimulation parameters selected using different methods.Docket No.: A0013320W001 / 1123-866W001

[0020] FIG. 15 is a flow diagram of an example technique for generating information on a user interface, in accordance with one or more techniques of this disclosure.

[0021] Like reference characters denote like elements throughout the description and figures.DETAILED DESCRIPTION

[0022] This disclosure describes examples of medical devices, systems, and techniques for displaying information for multiple electrodes to a user that is relevant to electrical stimulation therapy. Electrical stimulation therapy is typically delivered to a target tissue (e.g., brain tissue) of a patient via two or more electrodes. Parameters of the electrical stimulation therapy (e.g., electrode combination, voltage or current amplitude, pulse width, pulse frequency, etc.) are selected by a clinician and / or the patient to provide relief from various symptoms and / or treat various disorder as described herein. In some examples, parameters are selected and adjusted via a computing device (e.g., a programmer) with a user interface configured to receive user input. In some examples, a user (e.g., a clinician or patient) may select or adjust parameters based on information (e.g., signal information) that is sensed via the electrodes when the electrodes are implanted in a patient. In some examples, information is displayed on multiple screens, different tabs, etc. of a user interface (such as a user interface of a programmer), which may require that a user to navigate between the multiple screens, the different tabs, etc. in order to view the relevant information for selecting or adjusting the parameters for stimulation therapy. Relevant information being displayed on multiple screens may cause increased time and mental burden for users, and may lead to inaccuracies when selecting or adjusting parameters for electrical stimulation therapy.

[0023] In some examples, the clinician may be able to use one system to view visualizations of anatomical information of the patient or reference anatomical information. However, this anatomical information is typically displayed on separate systems. Therefore, when analyzing sensed signals from the patient, the system may not have information regarding the patient’s anatomy. This lack of connection between these pieces of information can reduce the accuracy of stimulation parameter selection, such as electrode configuration and / or stimulation amplitude. Moreover, the system may be unable to generate recommendations or other analysis based on different types of information for the patient.

[0024] As described herein, the devices, systems, and techniques of this disclosure enable display of relevant information for multiple electrodes at the same time (e.g., on a single screen of a user display) and relevant other information such as anatomical information, electrode position information, and / or stimulation field information, which may enable a user (e.g., aDocket No.: A0013320W001 / 1123-866W001 clinician or patient) to select or adjust parameters for stimulation therapy more quickly, more efficiently, and / or more accurately.

[0025] For example, the system may present signal information for multiple electrodes or electrode combinations (e.g., an indication of signal quality, ranking, etc.) while also presenting the signal information on the user interface for each electrode when the electrodes are positioned spatially with respect to anatomical structures. In this manner, the user interface can integrate sensing information and imaging information for the patient into a single solution that can be viewed on the same screen of the user interface. Examiner types of visualizations that the user interface can provide include visualizing imaging information (e.g., anatomical structures) with sensed signal information using markers (e.g., dots, triangles, squares, etc.), visualizing imaging information (e.g., anatomical structures) with sensed signal information using a heatmap, visualize imaging information with electrical signal (LFP) streaming data, visualize volume of neural activation (VNA) information with LFP streaming data and / or sensed data, and / or visualize imaging information with aggregate sensing data. The user interface can then directly display how stimulation parameters align with sensing information and / or imaging information. In addition, the clinician and patient can be provided a wholistic view of therapy planning using sensed, imaged, and modeled information.

[0026] As described herein, the devices, systems, and techniques of this disclosure enable efficient programming workflows for electrical stimulation therapy, e.g., via a user interface, with increased information accuracy, less clicks and / or more options available to a user to be accessed from a given screen of the user interface. For example, the system may present options to view different types of sensed information and / or modeled stimulation information together with anatomical information on one screen of the user interface. Additionally, the system may present options to update (e.g., refresh) test results, select different parameters (e.g., frequency), and or toggle alerts or system errors. In this way, the system reduces programming time, likelihood of human error, and mental burden by allowing access to various types of information from one screen.

[0027] Many brain disorders may be associated with abnormal brain function. In one example, Parkinson’s Disease (PD) is a progressive neuro-degenerative disorder characterized by the depletion of dopaminergic neurons in the basal ganglia-thalamo-cortical network. As PD progresses, the manifestations of the disease may include one or more of the characteristic motor dysfunctions that include one or more of akinesia, bradykinesia, rigidity, and tremor. In some examples, DBS therapy may be used to deliver electrical stimulation to treat motor symptoms in medication-refractory PD patients. In some examples, DBS therapy may involve the unilateral orDocket No.: A0013320W001 / 1123-866W001 bilateral implantation of one or more leads into the brain to deliver electrical stimulation to target structures in the basal ganglia. Selection of effective stimulation parameters for DBS therapy may be time-consuming for both the clinician (e.g., a physician, nurse, or technician) and the patient. As such, it may be desirable to reduce the amount of time consumed to select stimulation parameters. In addition, the trial-and-error approach for determining appropriate electrode combinations and / or other stimulation parameters may subject the patient to undesirable side effects during this lengthy process and / or may result in less than optimal stimulation parameters, thus lessening the therapeutic value of any therapy delivered.

[0028] The target region associated with a disease (e.g., PD) may generate signals of interest (e.g., Beta waves that may be indicative of symptoms such as tremor in PD). As described herein, a system may receive information representing one or more signals between different combinations of electrodes in order to highlight relevant differences between the sensed signals from each of the electrodes. The system may then generate information regarding these signals (e.g., a representation of the signal and / or a an indication signal quality, such as a ranking based on LFP magnitudes at respective frequencies), such as information that may be presented to a clinician and / or information used by the system to select parameter values for stimulation such which of the electrodes should serve as two or more stimulation electrodes. The sensed signals may be between electrodes at different circumferential positions and / or electrodes at different axial positions on one lead and a reference electrode on another lead (e.g., monopolar sensing). The clinician, or the system, may then determine parameters for stimulation based on one or more characteristics of these obtained signals instead of having to test stimulation provided by each electrode combination. For example, parameters for stimulation may include which electrodes are to be used for stimulation, a 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 cycling state (e.g., if cycling is “off,” stimulation is always on, and if cycling is “on,” stimulation is cycled 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 therapy program. It should be noted that an IMD may include a plurality of therapy programs which may include at least some parameters which are different than parameters of each other therapy program.

[0029] For example, a Beta rhythm may be localized with the dorsal subthalamic nucleus (STN). It may be helpful to select stimulation electrodes that may generate an electric field that affects this oscillatory region of the brain, which may in some examples be stimulation electrodesDocket No.: A0013320W001 / 1123-866W001 that are positioned proximally or optimally relative to the region. The system may detect electrical signals between different electrode combinations and process the signals to generate spectral power characteristics for one or more frequencies. For example, the system may perform a fast Fourier transform (FFT) that transforms the signals from the time domain into the frequency domain. The spectral power characteristics allow the signals to be analyzed for amplitudes of the signals at different frequencies or frequency bands. The system may then identify the electrode combinations, and thus axial (or level) and / or circumferential positions of the electrode combinations, associated with the spectral power characteristics indicative of stronger Beta waves. In some examples, the system may recommend the electrode combination associated with stronger Beta waves for targeted stimulation to this region of tissue. Although Beta waves may be used in some examples, other frequency bands such as frequencies in the gamma band may be selected instead. In addition, or alternatively, the system may present summary information relating to signal quality, such as a color or a graphical representation, to a clinician for different electrodes to enable the clinician to easily select which electrodes the clinician desires to use as stimulation electrodes. These indications of signal quality may be based on sensed LFPs (and / or characteristics such as spectral power) from different electrode combinations. The sensed LFPs may also be available for viewing by the clinician should the clinician desire to do so. In other examples, the indications signal quality and / or recommendation of electrodes may be based on other sensed signals, such as ECAP signals or other evoked responses.

[0030] The system may provide the summary information based on the sensed LFPs, such as via a colored representation, a graphical representation (such as a number of markers (e.g., dots), a sliding scale, or the like), other representation which may distinguish between more highly recommended and less highly recommended electrodes for use as stimulation electrodes, or some combination of these different representations. Such summary information may be presented on a same screen upon which a clinician may select or program an electrode as a stimulating electrode. Further, the summary information may be presented on the same screen showing other information from the patient, such as anatomical structures specific to the patient or an atlas structure, modeled stimulation such as a volume of neural activation (VNA) or stimulation field (e.g., voltage or current propagation), or any other information. In this manner, a clinician may select an electrode combination associated with desired attributes such as the stronger (e.g., larger amplitude spectral power) electrode amplitudes associated with Beta waves for subsequent sensing as well as those electrodes that correspond to the desired anatomical target.Docket No.: A0013320W001 / 1123-866W001

[0031] Each lead may have electrodes disposed at different axial (e.g., longitudinal) positions along the length of the lead. These electrodes may be ring electrodes and / or segmented electrodes that only reside around a limited portion of the perimeter of the lead. In the case of segmented electrodes that only reside around a limited portion of the perimeter (or circumference) of the lead, at a given axial position, each lead may have electrodes at different circumferential positions (e.g., at different positions around the perimeter of the lead). Hence, two or more segmented electrodes may be positioned at the same axial position along the length of the lead (e.g., on the same level of the lead). As an illustration, a 1-3-3-1 lead would have, in order, a ring electrode at a first, most proximal axial level, three segmented electrodes at different circumferential positions of a second, more distal axial level, three segmented electrodes at different circumferential positions of a third, still more distal axial level, and a ring electrode at a fourth, most distal axial level. In some examples, the system may group electrodes together as one polarity, e.g., as a group of cathodes, for use with another electrode of another polarity, e.g., an anode, or vice versa. The system may perform such groupings in order to balance impedance between cathodes and anodes and improve sensing fidelity. In one example, to sense between an axial level of the lead with a ring electrode and another axial level with multiple smaller, segmented electrodes at different circumferential positions, the system may group together those electrodes at different circumferential positions to create a virtual ring electrode (also referred to herein as segmented electrodes in a ring mode) that may improve sensing between an actual ring electrode and the virtual ring electrode. The grouping together of those electrodes at different circumferential positions to create a virtual ring electrode may be referred to as a ring mode.

[0032] Sensing electrical signals between different electrodes, including electrodes at different axial positions and at different circumferential positions, may provide valuable information about where certain electrical signals (e.g., signals in the Beta frequency band or Beta waves, alpha waves in an alpha band, gamma waves in a gamma band, theta waves in a theta band, and high frequency oscillations (HFO)) are originating from within tissue. In this manner, the system (or a clinician) may use this information to determine which electrodes (and / or other stimulation parameter values) should be used to deliver electrical stimulation therapy. The system may provide information representative of the sensed electrical signals via a display to enable a clinician to program stimulation more effectively and in less time than using trial-and-error approaches. In some examples, the theta band may refer to a frequency band of approximately 4-8 Hz, the alpha band may refer to a frequency band of approximately 8-12 Hz, the beta band may refer to a frequency band of approximately 13-30 Hz, and the gamma band may refer to a frequency band greater than 30 Hz.Docket No.: A0013320W001 / 1123-866W001

[0033] In general, as part of generating the one or more therapy programs, a clinician may select which electrodes to use for stimulation. For example, a clinician may utilize the medical device to record sensed electrical signals between different pairs of electrodes on a single lead (e.g., bipolar sensing) and a device to display representations of the recorded bipolar sensed electrical signals. However, generating the one or more therapy programs based on the representations of the recorded bipolar sensed electrical signals may not be intuitive for many clinicians. Additionally, bipolar sensing may be susceptible to electrocardiogram artifacts which may result in noisy sensed electrical signals, further complicating the stimulation electrode selection process.

[0034] Alternatively, as part of generating the one or more therapy programs, a clinician may perform a review to test each electrode and the effect of stimulating using each electrode on the symptoms of a patient. However, this process may take as several hours and be uncomfortable for the patient.

[0035] Moreover, even with systems that may provide monopolar sensing results to a clinician when determining one or more therapy programs, such results may not be provided in such a manner that a clinician may easily select appropriate electrodes as stimulation electrodes based on the results.

[0036] FIG. 1 is a conceptual diagram illustrating an example therapy system 10 that is configured to deliver therapy to patient 12 to manage a disorder of patient 12. Patient 12 ordinarily will be a human patient. In some cases, however, therapy system 10 may be applied to other mammalian or non-mammalian non-human patients. In the example shown in FIG. 1, therapy system 10 includes medical device programmer 14, implantable medical device (IMD) 16, lead extension 18, and one or more leads 20 A and 20B (collectively “leads 20”) with respective sets of electrodes 24 and / or electrodes 26. IMD 16 includes a stimulation generator (not shown in FIG. 1) configured to generate and deliver electrical stimulation therapy to a region of brain 28 (e.g., the STN region) of patient 12 via electrodes 24 and / or 26 of leads 20A and 20B, respectively.

[0037] In the example shown in FIG. 1, therapy system 10 may be referred to as a deep brain stimulation (DBS) system because IMD 16 is configured to deliver electrical stimulation therapy directly to the STN within brain 28. DBS may be used to treat or manage various patient conditions, such as, but not limited to, seizure disorders (e.g., epilepsy), pain, migraine headaches, psychiatric disorders (e.g., major depressive disorder (MDD), bipolar disorder, anxiety disorders, post-traumatic stress disorder, dysthymic disorder, and obsessive compulsive disorder (OCD)), behavior disorders, mood disorders, memory disorders, mentation disorders,Docket No.: A0013320W001 / 1123-866W001 movement disorders (e.g., essential tremor or Parkinson's disease), Huntington’s disease, Alzheimer’s disease, or other neurological or psychiatric disorders and impairment of patient 12.

[0038] In the example shown in FIG. 1, IMD 16 is be implanted within a subcutaneous pocket in the pectoral region of patient 12. In other examples, IMD 16 is be implanted within other regions of patient 12, such as a subcutaneous pocket in the abdomen or buttocks of patient 12 or proximate the cranium of patient 12. Implanted lead extension 18 is coupled to circuitry in IMD 16 via proximal electrical contacts that connect to electrical terminals in connector block 30 (also referred to as a header). Lead extension 18 may include, for example, distal electrical contacts that electrically couple to proximal electrical contacts of leads 20A, 20B, which in turn may be coupled to respective electrodes 24 and / or electrodes 26 via conductors within lead 20A and / or lead 20B. The proximal electrical contacts of lead 20A and / or lead 20B and the distal electrical contacts of lead extension 18 electrically couple the electrodes 24 and / or electrodes 26 carried by leads 20 to the proximal contacts of lead extension 18 via conductors within the lead extension 18, and in turn to circuitry of IMD 16 via terminals in connector block 30. Lead extension 18 traverses from the implant site of IMD 16 within a chest cavity of patient 12, along the neck of patient 12 and through the cranium of patient 12 to access brain 28. IMD 16 may be constructed of a biocompatible material that resists corrosion and degradation from bodily fluids. IMD 16 may comprise a hermetically sealed housing 34 to substantially enclose components, such as a processor, therapy circuitry, and memory.

[0039] In the example shown in FIG. 1, leads 20 are implanted within the right and left hemispheres, respectively, of brain 28 in order to deliver electrical stimulation to one or more regions of brain 28, that may be selected based on many factors, such as the type of patient condition that therapy system 10 is implemented to manage. Other implant sites for leads 20 and IMD 16 are contemplated. For example, IMD 16 may be implanted on or within cranium 32 or leads 20 may be implanted within the same hemisphere at multiple target tissue sites or IMD 16 may be coupled to a single lead that is implanted in one or both hemispheres of brain 28. In some examples, leads 20 are implanted endovascularly (e.g., within blood vessel) adjacent a target region of brain 28.

[0040] Leads 20 may be positioned to deliver electrical stimulation to one or more target tissue sites within brain 28 to manage patient symptoms associated with a disorder of patient 12. Leads 20 may be implanted to position electrodes 24 and / or electrodes 26 at desired locations of brain 28 via any suitable technique, such as through respective burr holes in the skull of patient 12 or through a common burr hole in the cranium 32. Leads 20 may be placed at any location within brain 28 such that electrodes 24 and / or electrodes 26 are capable of providing electricalDocket No.: A0013320W001 / 1123-866W001 stimulation to target therapy delivery sites within brain 28 during treatment. In the case of Parkinson’s disease, for example, leads 20 may be implanted to deliver electrical stimulation to regions within the STN, either unilaterally or bilaterally. Target therapy delivery sites not located in brain 28 of patient 12 are also contemplated.

[0041] Although leads 20 are shown in FIG. 1 as being coupled to a common lead extension 18, in other examples, leads 20 may be coupled to IMD 16 via separate lead extensions or directly coupled to IMD 16. Moreover, although FIG. 1 illustrates therapy system 10 as including two leads 20A and 20B coupled to IMD 16 via lead extension 18, in some examples, therapy system 10 may include one lead or more than two leads.

[0042] In the examples shown in FIG. 1, electrodes 24 A, 24D, 26 A, and 26D of leads 20 are shown as ring electrodes. Ring electrodes may be relatively easy to program and may be capable of delivering an electrical field to any tissue adjacent to leads 20. Electrodes 24B, 24C, 26B, and 26C of leads 20 may have different configurations. For example, electrodes 24B, 24C, 26B, and 26C of leads 20 may each have a complex electrode array geometry that is capable of producing shaped electrical fields. An example of a complex electrode array geometry may include an array of segmented electrodes positioned at different axial positions along the length of a lead, as well as at different angular (i.e., circumferential) positions about the periphery, e.g., circumference, of the lead. The complex electrode array geometry may include multiple electrodes (e.g., partial ring or segmented electrodes), such as electrode 24B, 24C, 26B, and 26C that each include multiple individually programmable electrodes located at different positions around the perimeter of each respective lead 20. Although electrodes 24A, 24D, 26A, and 26D may be ring electrodes that each extend fully around the perimeter of the lead, any of these electrodes may be replaced, in other examples, by multiple electrodes located at different positions around the perimeter of the lead. Although electrodes 24B, 24C, 26B, and 26C may be include multiple electrodes (e.g., partial ring electrodes or segmented electrodes), any of these electrodes may be replaced by ring electrodes. In this manner, one or more leads may have all ring electrodes, all segmented electrodes that do not extend around the full circumference of the lead, or a combination of one or more ring electrodes with one or more segmented electrodes. By using electrodes disposed at different positions around the perimeter of the lead, IMD 16 may deliver directional stimulation, with electrical stimulation that may be directed in a specific direction from leads 20 to enhance therapy efficacy and reduce possible adverse side effects from stimulating a large volume of tissue. As a further example, the electrodes may be pad electrodes, that may be carried on a paddle lead or a cylindrical lead.Docket No.: A0013320W001 / 1123-866W001

[0043] As illustrated in the example of FIG. 1, the set of electrodes 24 of lead 20 A may include electrodes 24A, 24B, 24C, and 24D, and the set 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 independently deliver electrical stimulation.

[0044] In some examples, outer housing 34 of IMD 16 may include one or more stimulation and / or sensing electrodes. Some or all of the electrodes may be used for both sensing and stimulation, or some electrodes may be dedicated to sensing while some other electrodes may be dedicated to stimulation. Housing 34 may comprise an electrically conductive material that is exposed to tissue of patient 12 when IMD 16 is implanted in patient 12, or an electrode may be attached to housing 34. Hence, in some examples, electrode combinations for stimulation and / or sensing may be formed by combinations of one or more electrodes on a lead or leads and one or more electrodes on housing 34 of IMD 16, or by combinations of two or more electrodes on a lead or leads. In other examples, leads 20 may have shapes other than elongated cylinders as shown in FIG. 1 with active or passive tip configurations. For example, leads 20 may be paddle leads, spherical leads, bendable leads, or any other type of shape effective in treating patient 12.

[0045] IMD 16 may deliver electrical stimulation therapy to brain 28 of patient 12 according to one or more stimulation therapy programs (also referred to herein as “set of stimulation parameter values”). A stimulation therapy program may define one or more electrical stimulation parameter values for therapy generated by a stimulation generator (not shown in FIG. 1) of IMD 16 and delivered from IMD 16 to a target therapy delivery site within patient 12 via one or more electrodes 24 and / or electrodes 26. The electrical stimulation parameters may define an aspect of the electrical stimulation therapy, and may include, for example, voltage or current amplitude of an electrical stimulation signal, a charge level of an electrical stimulation, a frequency of the electrical stimulation signal, waveform shape, on / off cycling state (e.g., if cycling is “off,” stimulation is always on, and if cycling is “on,” stimulation is cycled 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. In addition, if different electrodes are available for delivery of stimulation, an electrode combination may further characterize a therapy parameter of a therapy program, that may define selected electrodes 24 and / or electrodes 26 and their respective polarities. In some examples, stimulation may be delivered using a continuous waveform and the stimulation parameters may define this waveform, although stimulation will generally be described herein as being defined by stimulation pulses.

[0046] In addition to being configured to deliver therapy to manage a disorder of patient 12, therapy system 10 may be configured to sense bioelectrical brain signals or another physiologicalDocket No.: A0013320W001 / 1123-866W001 parameter of patient 12. For example, IMD 16 may include a sensing circuitry that is configured to sense bioelectrical brain signals within one or more regions of brain 28 via a subset of electrodes 24 and / or electrodes 26, another set of electrodes, or both. Accordingly, in some examples, electrodes 24 and / or electrodes 26 may be used to deliver electrical stimulation from the stimulation generator to target sites within brain 28 as well as sense brain signals within brain 28. However, IMD 16 may also use a separate set of sensing electrodes to sense the bioelectrical brain signals. In some examples, the sensing circuitry of IMD 16 may sense bioelectrical brain signals via one or more of the electrodes 24 and / or electrodes 26 that are also used to deliver electrical stimulation to brain 28. In other examples, one or more of electrodes 24 and / or electrodes 26 may be used to sense bioelectrical brain signals while one or more different electrodes 24 and / or electrodes 26 may be used to deliver electrical stimulation.

[0047] Programmer 14 is an external device that is configured to wirelessly communicate with IMD 16 as needed to provide or retrieve therapy information. Programmer 14 is an external computing device that the user, e.g., the clinician and / or patient 12, may use to communicate with IMD 16. For example, programmer 14 may be a clinician programmer that the clinician uses to communicate with IMD 16 and program one or more therapy programs for IMD 16. In addition, or instead, programmer 14 may be a patient programmer that allows patient 12 to select programs and / or view and modify therapy parameter values. The clinician programmer may include more programming features than the patient programmer. In other words, more complex or sensitive tasks may only be allowed by the clinician programmer to prevent an untrained patient from making undesired changes to IMD 16.

[0048] Programmer 14 may be a hand-held computing device with a display viewable by the user and an interface for providing input to programmer 14 (i.e., a user input mechanism). 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. In addition, programmer 14 may include a touch screen display, keypad, buttons, a peripheral pointing device, voice activation, or another input mechanism that allows the user to navigate through the user interface of programmer 14 and provide input. If programmer 14 includes buttons and a keypad, the buttons may be dedicated to performing a certain function, e.g., a power button, the buttons and the keypad may be soft keys that change in function depending upon the section of the user interface currently viewed by the user, or any combination thereof.

[0049] In other examples, programmer 14 may be a larger workstation or a separate application within another multi -function device, rather than a dedicated computing device. For example, the multi -function device may be a notebook computer, tablet computer, workstation,Docket No.: A0013320W001 / 1123-866W001 one or more servers, cellular phone, personal digital assistant, or another computing device that may run an application that enables the computing device to operate as a secure medical device programmer. A wireless adapter coupled to the computing device may enable secure communication between the computing device and IMD 16.

[0050] When programmer 14 is configured for use by the clinician, programmer 14 may be used to transmit programming information to IMD 16. Programming information may include, for example, hardware information, such as the type of leads 20, the arrangement of electrodes 24 and / or electrodes 26 on leads 20, the position of leads 20 within brain 28, one or more therapy programs defining therapy parameter values, therapeutic windows defining upper and lower amplitude limits for one or more electrodes 24 and / or electrodes 26, and any other information that may be useful for programming into IMD 16. Programmer 14 may also be capable of completing functional tests (e.g., measuring the impedance of electrodes 24 and / or electrodes 26 of leads 20).

[0051] The clinician may also generate and store therapy programs within IMD 16 with the aid of programmer 14. Programmer 14 may assist the clinician in the creation and / or identification of therapy programs by providing a system for identifying potentially beneficial therapy parameter values. For example, during a programming session, the physician may select an electrode combination for delivery of therapy to the patient. The physician may have the option to create several therapy programs. Some programs may have the same electrode combination to be used as stimulation electrodes (but different values of at least one other therapy parameter) and these therapy programs may be organized into subsets, each subset having the same electrode combination. The physician may select an efficacious therapy program for each subset based on a displayed list of sensed LFP signals from electrode combinations. The clinician may select a therapy program based on a list displayed on external programmer 14 of combinations of electrodes providing the largest LFP spectral power to provide therapy to patient 12 to address symptoms associated with the patient condition.

[0052] Programmer 14 may 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) in order to prevent patient 12 from altering critical functions of IMD 16 or applications that may be detrimental to patient 12.

[0053] Whether programmer 14 is configured for clinician or patient use, programmer 14 is configured to communicate with IMD 16 and, optionally, another computing device, via wireless communication. Programmer 14, for example, may communicate via wireless communication with IMD 16 using radio frequency (RF) and / or inductive telemetry techniques that mayDocket No.: A0013320W001 / 1123-866W001 comprise techniques for proximal, mid-range, or longer-range communication. Programmer 14 may also communicate with another programmer or computing device via a wired or wireless connection using any of a variety of local wireless communication techniques, such as RF communication according to the 802.11 or Bluetooth specification sets, infrared (IR) communication according to the Infrared Data Association (IRDA) specification set, or other standard or proprietary telemetry protocols. Programmer 14 may also communicate with other programming or computing devices via exchange of removable media, such as magnetic or optical disks, memory cards, or memory sticks. Further, programmer 14 may communicate with IMD 16 and another programmer via remote telemetry techniques known in the art, communicating via a personal area network (PAN), a local area network (LAN), wide area network (WAN), public switched telephone network (PSTN), or cellular telephone network, for example.

[0054] Therapy system 10 may be implemented to provide chronic stimulation therapy to patient 12 over the course of several months or years. However, therapy system 10 may also be employed on a trial basis to evaluate therapy before committing to full implantation. If implemented temporarily, some components of therapy system 10 may not be implanted within patient 12. For example, patient 12 may be fitted with an external medical device, such as a trial stimulator, rather than IMD 16. The external medical device may be coupled to percutaneous leads or to implanted leads via a percutaneous extension. If the trial stimulator indicates therapy system 10 provides effective treatment to patient 12, the clinician may implant a chronic stimulator within patient 12 for relatively long-term treatment. In another example, a clinician in an operating room may obtain acute recordings during lead placement and before coupling the lead with an IMD. In this example, an external device (e.g., an external electrophysiology system) may couple to the medical lead in order to obtain sensed electrical signals.

[0055] While DBS may successfully reduce symptoms of some neurological diseases, the stimulation may also cause unwanted side effects, also referred to herein as adverse effects. Side effects may include incontinence, tingling, loss of balance, paralysis, slurred speech, loss of memory, loss of inhibition, and many other neurological problems. Side effects may be mild to severe. DBS may cause one or more adverse effects by inadvertently providing electrical stimulation pulses to anatomical regions near the targeted anatomical region. These anatomical regions may be referred to as regions associated with adverse stimulation effects. For this reason, a clinician may program IMD 16 with a therapy program (or a plurality of therapy programs) that defines stimulation parameter values that balance effective therapy and minimize side effects. For example, a clinician may select electrodes to deliver stimulation that did not sense the largestDocket No.: A0013320W001 / 1123-866W001LFP spectral power if the electrodes that did sense the largest LFP spectral power is located in a region associated with adverse stimulation effects or if electrodes that delivered stimulation that resulted in the largest LFP spectral power is too high for patient comfort.

[0056] With the aid of programmer 14 or another computing device, a clinician may select values for therapy parameters for therapy system 10, including an electrode combination to be used as stimulation electrodes. By selecting particular electrodes of electrodes 24 and / or electrodes 26 and electrode combinations for delivering electrical stimulation therapy to patient 12, a clinician may modify the electrical stimulation therapy to target one or more particular regions of tissue (e.g., specific anatomical structures) within brain 28 and avoid other regions of tissue within brain 28. In addition, by selecting values for the other stimulation parameter values that define the electrical stimulation signal, e.g., the amplitude, pulse width, and pulse rate, the clinician may generate an efficacious therapy for patient 12 that is delivered via the selected electrode subset. Due to physiological diversity, condition differences, and inaccuracies in lead placement, the parameter values may vary between patients.

[0057] During a programming session, the clinician may determine one or more therapy programs that may provide effective therapy to patient 12. Patient 12 may provide feedback to the clinician as to the efficacy of the specific program being evaluated, that may include information regarding adverse effects of delivery of therapy according to the specific program. In some examples, the patient feedback may be used to determine a clinical rating scale score. Once the clinician has identified one or more programs that may be beneficial to patient 12, patient 12 may continue the evaluation process and determine which program best alleviates the condition of patient 12 or otherwise provides efficacious therapy to patient 12. Programmer 14 may assist the clinician in the creation / identification of therapy programs by providing a methodical system of identifying potentially beneficial therapy parameters.

[0058] In another example, lead 20 may be implanted directly at the target tissue (e.g., in a region with the strongest beta oscillation or largest amplitude of a target frequency). In another example, lead 20 may be implanted based purely on anatomy alone (e.g., placed in the STN). In either of these examples, due to various uncertainties associated with the lead placement procedure, the location of the medical lead may not be the same as the region generating the maximal signal source, resulting in an offset between the target anatomy and the lead location. However, it is not necessary for lead 20 to be offset from the target anatomy as a lead placed at the target tissue that generates the strongest signal may provide effective stimulation therapy. A clinician may choose to implant lead 20 offset from target tissue or directly at or within the target tissue that generates the strongest signal. However, visualizing the location of electrodes withDocket No.: A0013320W001 / 1123-866W001 respect to anatomical structures, such as the STN, an sensed signal information for the electrodes can be beneficial for identifying appropriate stimulation parameters.

[0059] When using medical leads with larger number of electrodes, the time necessary for a review by a clinician grows. Further, the exploration and programming time required for directional stimulation across multiple combinations of electrodes increases as well. To reduce the time required of the patient and the clinician, in some examples, an indication of a signal quality (e.g., ranking or rating based on one or more characteristics of the signals such as absolute LFP magnitudes, relative LFP magnitudes compared to other electrodes, presence of an artifact, presence of noise, etc.) based on sensed electrical signals sensed by multiple combinations of electrodes may be displayed to the clinician. The clinician may then select, or the system may automatically select, electrodes to provide electrical stimulation based on the sensed signals (e.g., the electrodes that sensed the greatest signal strength).

[0060] In some examples, 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 comprising a same reference electrode of a first lead and at least one, different sense electrode of a second lead. In some examples, one or more of the reference or sense electrodes may reside on a housing or “can” of IMD 16, rather than on a lead. In some examples, IMD 16 includes processing circuitry configured to record the sensed electrical signals from the first plurality of electrode combinations, provide representations of the recorded sensed electrical signals, receive an indication, from a clinician, of two or more selected electrodes, and control delivery of electrical stimulation via the two or more selected electrodes.

[0061] These sensed electrical signals for the particular patient from combinations of electrodes 24 and / or electrodes 26 may be represented on a display or user interface (not shown in FIG. 1) at programmer 14, and / or another computing device. A clinician may select an electrode combination to be used as stimulation electrodes to provide stimulation therapy based on sensed signals from a plurality of different electrode combinations. For instance, a clinician may select an electrode combination including a combination of one or more of electrodes 24 and an electrode on IMD 16 (e.g., a case electrode or can electrode), a combination of one or more of electrodes 26 and an electrode on IMD 16, a combination of two or more of electrodes 24, a combination of two or more of electrodes 26, or a combination of one or more of electrodes 24 and one or more of electrodes 26 to be used as stimulation electrodes.

[0062] IMD 16 may be configured to deliver electrical stimulation to the particular patient via the clinician selected electrode combination. As one example, where a clinician selects the electrode combination, the clinician may select the therapy to deliver electrical stimulation to theDocket No.: A0013320W001 / 1123-866W001 particular patient via the selected electrode combination. As yet another example, the clinician may input the selected electrode combination to programmer 14 such that programmer 14 automatically selects a stimulation therapy program and configures IMD 16 to deliver electrical stimulation to the particular patient via the selected electrode combination. As yet another example, the clinician may use a computing device to select an electrode combination that may be communicated to programmer 14 that may configure IMD 16 to deliver electrical stimulation to the particular patient via the clinician-selected electrode combination.

[0063] When programing therapy programs for IMD 16 via programmer 14, a clinician may utilize the sensed electrical signals to select the stimulation electrodes to be used for a given therapy program. In order to facilitate the selection of the stimulation electrodes based on the sensed electrical signals, it may be desirable to provide an indication of signal quality, such as color-based representation (e.g., a single color or combination or colors) and / or graphical representation of a ranking for one or more of the electrodes that could possibly be used to sense signals during therapy for closed-loop feedback and / or as stimulation electrodes on a same programming screen through which the clinician may select the electrodes that are to be the stimulation electrodes for a given therapy program. This signal quality or ranking may be based on the sensed electrical signals for those respective electrodes. By providing an indication of signal quality, for example a color-based representation and / or graphical representation of a ranking of one or more of the electrodes on a same screen from which a clinician may select electrodes to be sensing electrodes and / or stimulation electrodes, the techniques of this disclosure may reduce a likelihood that a clinician will make an error in selecting stimulation electrodes, reduce the cognitive load on the clinician, reduce a need for the clinician to take notes when navigating between screens including sensed electrical signals and a programming screen, and / or provide improved patient outcomes as any therapy programs may be more likely to be efficacious due to the improved ease and ability for a clinician to properly select the stimulation electrodes.

[0064] In some examples, programmer 14 receives signal information representing one or more signals sensed via at least one electrode of electrodes 24 and / or electrodes 26 of IMD 16. In some examples, programmer 14 generates, for presentation via a screen of the a user interface, a representation of the sensed signals (e.g., the signal quality indicators) for respective electrodes together with spatial information of the electrodes to anatomical structures. In some examples, programmer 14 generates, for presentation via the screen of the user interface, a representation of some or all of electrodes 24 and / or electrodes 26 and an indication of signal quality based on the received signal information for each electrode of electrodes 24 and / or electrodes 26, wherein theDocket No.: A0013320W001 / 1123-866W001 indication of signal quality corresponds to at least one frequency on the frequency spectrum. In some examples, VNA information or other information may also be presented on the screen.

[0065] FIG. 2 is functional block diagram illustrating components of an example IMD 16. In the example shown in FIG. 2, IMD 16 includes processing circuitry 60, memory 62, stimulation generator 64, sensing circuitry 66, interface 68, telemetry circuitry 70, and power source 72. Memory 62, as well as other memories described herein, may include any volatile or non-volatile media, such as a random-access memory (RAM), read only memory (ROM), non-volatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), flash memory, and the like. Memory 62 may store computer-readable instructions that, when executed by processing circuitry 60, cause IMD 16 to perform various functions described herein.

[0066] In the example shown in FIG. 2, memory 62 may store therapy programs 74, operating instructions 76, and electrode selection algorithm 78, e.g., in separate memories within memory 62 or separate areas within memory 62. Each stored therapy program 74 defines a particular program of therapy in terms of respective values for electrical stimulation parameters, such as an electrode combination to be used as stimulation electrodes, current or voltage amplitude, and, if stimulation generator 64 generates and delivers stimulation pulses, the therapy programs may define values for a pulse width and pulse rate (i.e., pulse frequency) of a stimulation signal. Each stored therapy program 74 may also be referred to as a set of stimulation parameter values. Operating instructions 76 guide general operation of IMD 16 under control of processing circuitry 60 and may include instructions for monitoring brain signals within one or more brain regions via electrodes 24 and / or electrodes 26 and delivering electrical stimulation therapy to patient 12. As discussed in further detail below and in accordance with one or more techniques of this disclosure, in some examples, memory 62 may store electrode selection algorithm 78, that may include instructions that are executable by processing circuitry 60 to select two or more electrodes to sense electrical stimulation. For instance, electrode selection algorithm 78 may be executable 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 executable by processing circuitry 60 to determine an indication of signal quality, such as a color-based representation and / or graphical representation of a ranking of signal quality for one or more of the electrodes or electrode combinations of electrodes 24 and / or electrodes 26 to deliver electrical stimulation based on the sensed electrical signals. In some examples, electrode selection algorithm 78 may be executable by processing circuitry 60 to select one or moreDocket No.: A0013320W001 / 1123-866W001 electrode combinations of electrodes 24 and / or electrodes 26 to deliver electrical stimulation based on input from a user, such as a clinician.

[0067] Stimulation generator 64, under the control of processing circuitry 60, generates stimulation signals for delivery to patient 12 via selected combinations of stimulation electrodes of electrodes 24 and / or electrodes 26. In some examples, stimulation generator 64 generates and delivers stimulation signals to one or more target regions of brain 28 (FIG. 1), via a selected electrode combination of stimulation electrodes from electrodes 24 and / or electrodes 26, based on one or more stored therapy programs 74. In some examples, therapy programs 74 are chosen at programmer 14 and / or an external computer and transferred to IMD 16 and stored in memory 62. The target tissue sites within brain 28 for stimulation signals or other types of therapy and stimulation parameter values may depend on the patient condition for which therapy system 10 is implemented to manage. While stimulation pulses are described, stimulation signals may be of any form, such as continuous-time signals (e.g., sine waves) or the like.

[0068] The processor(s) 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 logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry, or combinations thereof. The functions attributed to processors described herein may be provided by a hardware device and embodied as software, firmware, hardware, or any combination thereof. Processing circuitry 60 is configured to control stimulation generator 64 according to therapy programs 74 stored by memory 62 to apply particular stimulation parameter values specified by one or more programs, such as amplitude, pulse width, and pulse rate.

[0069] In the example shown in FIG. 2, the set of electrodes 24 of lead 20A includes electrodes 24A-24D, and the set of electrodes 26 of lead 20B includes electrodes 26A-26D. Processing circuitry 60 may control interface 68 to apply the stimulation signals generated by stimulation generator 64 to a selected electrode combination of stimulation electrodes from electrodes 24 and / or electrodes 26. In some examples, interface 68 may direct or switch individual voltage or current sources and sinks couplable to each electrode (i.e., a separate voltage and / or current source and sink for each of electrodes 24 and / or electrodes 26). In some examples, interface 68 may include switch circuitry that may couple stimulation signals to selected conductors within leads 20, that, in turn, deliver the stimulation signals across selected electrodes 24 and / or electrodes 26. In the example where interface 68 includes switch circuitry, the switch 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 24Docket No.: A0013320W001 / 1123-866W001 and / or electrodes 26 and to selectively sense bioelectrical brain signals with selected electrodes 24 and / or electrodes 26. In some examples, switch circuitry may be used to couple sensing electrodes of electrodes 24 and / or 26 to sensing circuitry 66, but not to couple stimulation electrodes of electrodes 24 and / or 26 to stimulation generator 64. Hence, stimulation generator 64 is coupled to electrodes 24 and / or electrodes 26 via interface 68 and conductors within leads 20.

[0070] As discussed above, processing circuitry 60 may control interface 68 to apply the stimulation signals generated by stimulation generator 64, or sense electrical signals by sensing circuitry 66, to a selected electrode combination of electrodes 24 and / or electrodes 26. In some examples, the selected electrode combination may be monopolar. For example, one or more electrodes (e.g., one or more cathodes) may be located on lead 20A and the other electrode (e.g., an anode) may be located on lead 20B, or another location on lead 20A with suitable spacing further from the target region to be sensed, and the spacing between sensing electrodes may be greater than 30 mm from the spatial extent of the signal source (e.g., 3 - 9 mm). In some examples, the reference electrode may be located on a burr hole cap, be coupled to the burr hole cap, or located elsewhere in the body. In some examples, the selected electrode combination of electrodes 24 and / or electrodes 26 may be unipolar. Monopolar electrode combinations described herein include unipolar electrode combinations such that a unipolar selected combination may include one electrode of either electrodes 24 or electrodes 26 in combination with an electrode on the housing of IMD 16 (i.e., case or can), where one is an anode and the other is a cathode. In other examples, the selected electrode combination of electrodes 24 and / or electrodes 26 may be bipolar. As one example, a bipolar selected combination may include two electrodes from electrodes 24, where one is an anode and the other is a cathode. As another example, a bipolar selected combination may include two electrodes from electrodes 26, where one is an anode and the other is a cathode. As another example, a bipolar selected combination may include an electrode from electrodes 24 and an electrode from electrodes 26, where one is an anode and the other is a cathode. If only one lead is implanted, the system may use different combinations of electrodes on the same lead to sense signals. In some examples, the selected electrode combination of electrodes 24 and / or electrodes 26 may be multipolar. As one example, a multipolar selected combination may include multiple anodes and / or multiple cathodes selected from electrodes 24. As another example, a multipolar selected combination may include multiple anodes and / or multiple cathodes selected from electrodes 26. As one example, a multipolar selected combination may include multiple anodes and / or multiple cathodes selected from electrodes 24 and electrodes 26.Docket No.: A0013320W001 / 1123-866W001

[0071] Stimulation generator 64 may be a single channel or multi-channel stimulation generator. In particular, stimulation generator 64 may be capable of delivering a single stimulation pulse, multiple stimulation pulses or continuous signal at a given time via a single electrode combination or multiple stimulation pulses at a given time via multiple electrode combinations. In some examples, however, stimulation generator 64 and interface 68 may be configured to deliver multiple channels on a time-interleaved basis. For example, interface 68 may serve to time divide the output of stimulation generator 64 across different electrode combinations at different times to deliver multiple programs or channels of stimulation energy to patient 12.

[0072] Sensing circuitry 66, under the control of processing circuitry 60, is configured to sense bioelectrical brain signals of patient 12 via a selected subset of electrode combinations with one or more electrodes 24 and / or electrodes 26 and at least a portion of a conductive outer housing 34 of IMD 16, an electrode on an outer housing of IMD 16 or another reference. Processing circuitry 60 may control interface 68 to electrically connect sensing circuitry 66 to selected electrodes 24 and / or electrodes 26. In this way, sensing circuitry 66 may selectively sense bioelectrical brain signals with different combinations of electrodes 24 and / or electrodes 26 (and / or a reference other than an electrode of electrodes 24 and / or electrodes 26).

[0073] Although sensing circuitry 66 is incorporated into a common housing 34 with stimulation generator 64 and processing circuitry 60 in FIG. 2, in other examples, sensing circuitry 66 is in a separate outer housing from outer housing 34 of IMD 16 and communicates with processing circuitry 60 via wired or wireless communication techniques.

[0074] Telemetry circuitry 70 is configured to support wireless communication between IMD 16 and a programmer 14 or another computing device under the control of processing circuitry 60. Processing circuitry 60 of IMD 16 may receive a command to execute electrode selection algorithm 78 from programmer 14 and / or therapy programs 74 via telemetry circuitry 70. Therapy programs 74 may include indication(s) of selected stimulation electrodes. Processing circuitry 60 of IMD 16 may also receive, as updates to programs, values for various stimulation parameters such as amplitude and electrode combination for stimulation electrodes, from programmer 14 via telemetry circuitry 70. The updates to the therapy programs may be stored within therapy programs 74 portion of memory 62, as discussed above. Telemetry circuitry 70 in IMD 16, as well as telemetry circuitry in other devices and systems described herein, such as programmer 14, may accomplish communication by RF communication techniques. In addition, telemetry circuitry 70 may communicate with programmer 14 via proximal inductive interaction of IMD 16 with programmer 14. Accordingly, telemetry circuitry 70 may send information toDocket No.: A0013320W001 / 1123-866W001 external programmer 14 on a continuous basis, at periodic intervals, or upon request from IMD 16 or programmer 14.

[0075] Power source 72 delivers operating power to various components of IMD 16. Power source 72 may include a small rechargeable or non-rechargeable battery and a power generation circuit to produce the operating power. Recharging may be accomplished through proximal inductive interaction between an external charger and an inductive charging coil within IMD 16. In some examples, power requirements may be small enough to allow IMD 16 to utilize patient motion and implement a kinetic energy-scavenging device to trickle charge a rechargeable battery. In other examples, traditional batteries may be used for a limited period of time.

[0076] FIG. 3 is a functional block diagram illustrating components of an example medical device programmer. In the example of FIG. 3, programmer 14 includes processing circuitry 80, memory 82, telemetry circuitry 84, user interface 86 with display 83, and power source 88. Processing circuitry 80 controls user interface 86 and telemetry circuitry 84 and stores and retrieves information and instructions to and from memory 82. Programmer 14 may be configured for use as a clinician programmer or a patient programmer. Processing circuitry 80 may comprise any combination of one or more processors including one or more microprocessors, DSPs, ASICs, FPGAs, or other equivalent integrated or discrete logic circuitry. Accordingly, processing circuitry 80 may include any suitable structure, whether in hardware, software, firmware, or any combination thereof, to perform the functions ascribed herein to processing circuitry 80.

[0077] A user, such as a clinician or patient 12, may interact with programmer 14 through user interface 86. User interface 86 includes a display 83, such as an LCD or LED display or other type of screen, with which processing circuitry 80 may present information related to the therapy (e.g., electrode combinations) and sensed electrical signals. In addition, user interface 86 may include one or more input device(s) 90, such as input mechanisms to receive input from the user. Input device(s) 90 may include, for example, any one or more of buttons, a keypad (e.g., an alphanumeric keypad), a peripheral pointing device (e.g., a mouse, rollerball, joystick, or the like), a touch screen for display 83, or another input mechanism that allows the user to navigate through screen(s) 89 presented by processing circuitry 80 of programmer 14 and provide input. In other examples, user interface 86 also includes audio circuitry for providing audible notifications, instructions or other sounds to patient 12, receiving voice commands from patient 12, or both. In some examples, the collection of screens 89 of graphical information that is presented on display 83 may be referred to as a user interface. In some examples, display 83 mayDocket No.: A0013320W001 / 1123-866W001 include a touch-sensitive input device 90 alone or in addition to one or more other input devices 90 separate from display 83.

[0078] Memory 82 may include instructions for operating user interface 86 and telemetry circuitry 84, and for managing power source 88. In the example shown in FIG. 3, memory 82 also stores electrode selection algorithm 87. Electrode selection algorithm 87 may be similar to electrode selection algorithm 78 of IMD 16 shown in FIG. 2 or may be a corollary to electrode selection algorithm 78 configured to interact with electrode selection algorithm 78 to perform stimulating electrode selection techniques. Electrode selection algorithm 87, that may include instructions that are executable by processing circuitry 80 to command IMD 16 to execute electrode selection algorithm 78 so as to test various electrode combinations as described herein and sense resulting electrical signals. In some examples, processing circuitry 60 of IMD 16 may analyze the sensed electrical signals and determine a respective indication of signal quality, such as a color-based representation and / or graphical representation of a ranking for the tested electrodes and transmit the sensed electrical signals and the respective indications of signal quality to programmer 14 via telemetry circuitry 70. Processing circuitry 60 may also generate visualizations of anatomical structures from imaging information, VNA and / or other stimulation field information, or any other information for display on the user interface to assist programming. In some examples, processing circuitry 60 of IMD 16 may transmit the sensed electrical signals to programmer 14 via telemetry circuitry 70 and processing circuitry 80 may determine the respective indications of signal quality. In either case, processing circuitry 60 (e.g., before transmission) and / or processing circuitry 80 (after receipt) may process the sensed electrical signals, such as to remove noise, improve signal to noise ratio, or the like.

[0079] In some examples, processing circuitry 80 executing electrode selection algorithm 87 may invoke screen(s) 89 causing processing circuitry 80 to load one or more screens of screen(s) 89 from memory 82 to display 83. For instance, processing circuitry 80 may present electrode selection algorithm 87 may be executable by processing circuitry 80 to select two or more of electrodes and electrode combinations to sense electrical signals in accordance with the techniques described below.

[0080] In some examples, screen(s) 89 may include a segments programming screen and a levels programming screen for a given lead. For example, a segments programming screen may depict a respective indication of signal quality (e.g., a respective color-based representation and / or graphical representation of a ranking for one or more of the electrodes) for each segmented electrode either of a given level or of all levels, while a levels programming screen may depict a respective indication of signal quality (e.g., a respective color-based representationDocket No.: A0013320W001 / 1123-866W001 and / or graphical representation of a ranking for one or more of the electrodes) for each level, such as where segmented electrodes are functioning as virtual ring electrodes. However, in some examples, indications of signal quality for both segments and levels are shown simultaneously on screen(s) 89.

[0081] In some examples, processing circuitry 80 may store the sensed electrical signals in results 92. In some examples, processing circuitry 80 may store sensed electrical signals from a plurality of different programming sessions over time in results 92. This would permit a clinician to review stored sensed electrical signals over time to monitor or assess disease progression, lead migration, shorts, damaged electrodes, or the like. In some examples, results 92 may alternatively or additionally be stored on a server, such as a web service server or a hospital server.

[0082] In some examples, processing circuitry 80 may compare the sensed electrical signals stored over time (e.g., in results 92) to determine a change in sensed electrical signals over time. Processing circuitry 80 may, based on determining the change in the sensed electrical signals, provide notification 94 indicative of the change in the sensed electrical signals. It should be noted that the sensed electrical signals may be processed prior to being saved in results 92 and / or may be saved in their raw form. As such, stored sensed electrical signals may be said to be representations of electrical signals. In some examples, to reduce the number of notifications 94 that may be provided by processing circuitry 80, the providing of notification 94 may be further based on a magnitude of the change in the representations of the electrical signals being greater than or greater than or equal to a threshold.

[0083] In some examples, patient 12, a clinician or another user may interact with user interface 86 of programmer 14 in other ways to manually select therapy programs, or combinations of electrodes (e.g., stimulation electrodes), generate new therapy programs, modify therapy programs, transmit the new programs to IMD 16, or any combination thereof. However, as discussed previously, processing circuitry 80 may also be configured to automatically select combinations of electrodes (e.g., stimulation electrodes), generate new therapy programs, modify therapy programs, and transmit the new programs to IMD 16. In this manner, processing circuitry 80 is configured to program, via telemetry circuitry 84, IMD 16 to provide electrical stimulation therapy according to a stimulation therapy program, the stimulation therapy program defining an electrode combination (e.g., of electrodes 24 and / or electrodes 26) for deep brain stimulation (DBS) therapy based on the indication of signal quality for each electrode of the plurality of electrodes. Similarly, processing circuitry 80 is configured to adjust the stimulation therapy program based on the one or more signals sensed via the at least one electrode of electrodes 24 and / or electrodes 26.Docket No.: A0013320W001 / 1123-866W001

[0084] Memory 82 may include any volatile or nonvolatile memory, such as RAM, ROM, EEPROM or flash memory. Memory 82 may also include a removable memory portion that may be used to provide memory updates or increases in memory capacities. A removable memory may also allow sensitive patient data to be removed before programmer 14 is used by a different patient.

[0085] Wireless telemetry in programmer 14 may be accomplished by RF communication or proximal inductive interaction of programmer 14 with IMD 16. This wireless communication is possible through the use of telemetry circuitry 84. Accordingly, telemetry circuitry 84 may be similar to the telemetry circuitry contained within IMD 16. In other examples, programmer 14 may be capable of infrared communication or direct communication through a wired connection. In this manner, other external devices may be capable of communicating with programmer 14 without needing to establish a secure wireless connection.

[0086] Power source 88 is configured to deliver operating power to the components of programmer 14. Power source 88 may include a battery and a power generation circuit to produce the operating power. In some examples, the battery may be rechargeable to allow extended operation. Recharging may be accomplished by electrically coupling power source 88 to a cradle or plug that is connected to an alternating current (AC) outlet. In addition, recharging may be accomplished through proximal inductive interaction between an external charger and an inductive charging coil within programmer 14. In other examples, traditional batteries (e.g., nickel cadmium or lithium-ion batteries) may be used. In addition, programmer 14 may be directly coupled to an alternating current outlet to operate.

[0087] While various information is illustrated and described as stored in memory 82 of programmer 14, it will be understood that some or all of this information may alternatively or additionally be stored within memory 62 of IMD 16. Moreover, at least some of the functionality ascribed to processing circuitry 80 of programmer 14 may instead or additionally be ascribed to processing circuitry 60 of IMD as discussed below (and vice versa).

[0088] Programmer 14 may provide various techniques to assist programming. Programmer 14 may provide a user interface that supports electrode configuration selection, electrode sensing, electrical signal streaming (e.g., LFP sensed data over time), analysis and / or presentation of anatomical models, and / or imaging information of the patient such as MRI, CT, diffusion tensor imaging (DTI), etc. FIGS. 4-13 are examples of various displays that may be generated and presented as, or part of, a user interface for programming stimulation therapy. Various examples of a user interface may incorporate any combination of these techniques and different information regarding the patient and implanted devices.Docket No.: A0013320W001 / 1123-866W001

[0089] FIGS. 4 and 5 are conceptual diagrams illustrating an example user interface that includes a screen displaying a representation of a lead, anatomical structure, and representations of sensed signal quality. The signal quality may be a metric that is calculated based on one or more characteristics of the signals such as absolute LFP magnitudes, relative LFP magnitudes compared to other electrodes, presence of an artifact, presence of noise, etc.). In some examples, the signal quality may refer to an absolute strength of the signal from each electrode or relative strength of each electrode in comparison with other electrodes of the lead(s). As shown in FIG.4, programmer 104 can present user interface 400 that includes screen 402. Screen 402 can show group 404 which is a group of stimulation parameters that define therapy, lead selector 406 which shows the lead that is being programmed, and tab 408 that indicates which element of programming is shown in field 410. Field 410 includes visualizations of various information, such as anatomical structure 416, lead 414, and flags 420B, 420C, 422B, and 422C (collectively “flags 420 and 422”) that include the signal quality indication in the form of “dots”. The number and / or color of dots in each of flag indicates the signal quality that has been sensed from that electrode. Toggle 412 can turn the flags on or off, and in some examples, can change to different types of information that can be displayed within field 410. Although dots are described as one example of a marker, other types of markers may be used in other examples. Example markers may include dots, triangles, squares, lines, etc.

[0090] The “dots” can be displayed in many ways. As shown, respective flag 420 and 422 can include the dots indicating signal quality, or the “dots” can be directly projected on the DBS lead and / or electrodes. “Dots” can be shown for axial levels of electrodes and / or each electrode segment at respective locations around the perimeter of the lead.

[0091] In some examples, the “dots” can be calculated from techniques for identifying electrodes and / or sensed signals, ERNA (monopolar or bipolar) signals, or output calculated from a combination of LFP and ERNA sensing techniques. In some examples, imaging can also be displayed using 2D images.

[0092] Screen 402 can also receive changes to stimulation parameters using slider 430 or buttons 432. Handle 440 indicates that the user can rotate the visualizations within field 410 in any direction to see the spatial relationship of the elements within field 410.

[0093] As shown in the example of FIG. 5, screen 502 indicates that elements in field 410 have been rotated to expose different electrodes on lead 414. These different electrodes are associated with flags 420A and 422Athat include the respective dots of signal quality. In other examples, the flags may display a different type of indicator of signal quality, such as bars, numbers, etc.Docket No.: A0013320W001 / 1123-866W001

[0094] FIGS. 6 and 7 are conceptual diagrams illustrating an example user interface that includes a screen displaying a representation of a lead, anatomical structure, and representations of sensed signal quality. As shown in FIG. 6, programmer 104 can present user interface 400 that includes screen 602, which can be similar to screen 402. Field 610 includes visualizations of various information, such as anatomical structure 416, lead 414, and heat maps 620B, 620C, 622B, and 622C (collectively “heat maps 420 and 422”) that include the signal quality indication in the form of color indications according to key 630. For example, red can indicate the “most” signal was detected, purple can indicate the “medium” magnitude of signal, and blue can indicate the “least” magnitude of signals. Toggle 412 can turn the heat maps on or off, and in some examples, can change to different types of information (such as dots) that can be displayed within field 610.

[0095] In some examples, the heat maps for each electrode can be calculated from techniques for identifying electrodes and / or sensed signals, ERNA (monopolar or bipolar) signals, or output calculated from a combination of LFP and ERNA sensing techniques. In some examples, imaging can also be displayed using 2D images. Screen 402 can also receive changes to stimulation parameters using slider 430 or buttons 432. A handle, such as handle 440, can be shown to indicate that the user can rotate the visualizations within field 610 in any direction to see the spatial relationship of the elements within field 610.

[0096] As shown in the example of FIG. 7, screen 702 indicates that elements in field 610 have been rotated to expose different electrodes on lead 414. These different electrodes are associated with heat maps 620A and 622Athat include the respective heat maps of signal quality. In other examples, the heat maps may display a different type of indicator of signal quality, such as numbers, shapes, etc.

[0097] FIGS. 8 and 9 are conceptual diagrams illustrating an example user interface 400 that includes a screen displaying a representation of a lead, anatomical structure, volume of activation, and representations of sensed signal quality. As shown in the example of FIG. 8, programmer 104 can present user interface 400 that includes screen 802, which can be similar to screen 402. Field 810 includes visualizations of various information, such as anatomical structure 416, lead 414, electrodes 818 and 824, and VNA 820 that is a representation of the volume of neural tissue that would be activated from stimulation according to the currently selected stimulation parameters (e.g., electrode combination, amplitude, pulse width, frequency, etc.). VNA 820 may be shown as a different color from the color of anatomical structure 416, and VNA 820 may be displayed over or partially transparent with respect to anatomical structure 416 and / or lead 414.Docket No.: A0013320W001 / 1123-866W001

[0098] Signal window 830 may present information representative of the sensed signals using VNA 820. For example, programmer 14 may analyzed sensed LFP signals during stimulation represented by VNA 820 and provide an indication of how the power of LFP signals is detected. As shown in FIG. 8, the stimulation has suppressed 30% of power in the Beta band, and no power has been detected in Gamma band. Toggle 812 can turn VNA 820 on or off, and in some examples, can change to, or add, different types of information (such as dots) that can be displayed within field 810. LFP signals may be sensed during any streaming sessions. In some examples, LFP signals can be obtained without stimulation (e.g., as a baseline), during an amplitude titration, and / or from one or more VNA stimulation events. Programmer 14 may analyze the LFP signals from these different events and display information for any frequency of interest behavior (e.g., beta suppression, gamma detection, alpha power, etc.). In this manner, programmer 14 may display comparative information associated with the delivered stimulation that can inform stimulation programming.

[0099] As shown in the example of FIG. 9, screen 902 indicates that elements in field 810 have been changed to reflect the increase in simulation amplitude, such as the larger VNA 920 when compared to VNA 820. VNA 920 now is larger than anatomical region 416 as shown by extending farther out. As shown in signal window 830, stimulation of VNA 920 is suppressing 80% of Beta power, but now Gamma frequencies are detected which may indicate unwanted side effects.

[0100] User interface 400 may enable the clinician can choose frequencies of interest for any information. These frequencies do not need to be within beta and gamma frequency bands. If the sensed signals are ERNA signals, the shown information could relate to ERNA amplitude of interest or latencies. Results from streaming could include other parameters (e.g., uVp level, variance, etc.). In some examples, programmer 14 may be configured to track more than two frequencies and then choose a desired result (percent suppression vs. detection) as appropriate for the patient. In some examples, programmer 14 may track LFP frequency of interest and ERNA feature of interest, thus utilizing two or more types of signals. User interface 400 can report back VNA results such as VNA volume (mm3) overlapping with STN or a percent of VNA volume within the STN to understand alignment of therapeutic programming.

[0101] VNA statistics can also be presented on the screen. These statistics can include: the percentage of VNA outside / within brain target, the volume of VNA outside / within brain target, the percentage of VNA in other structure(s), tractography (e.g., diffusion tensor imaging (DTI) information), or the volume of VNA in other structure(s). the same metrics as above can also be provided for substructures (i.e. motor area of STN vs. limbic area of STN). In some examples,Docket No.: A0013320W001 / 1123-866W001 user interface 400 can mark when VNA first breaches brain target and / or mark when VNA enters a region that should be avoided.

[0102] FIG. 10 is a conceptual diagram illustrating an example user interface that includes a screen displaying representations of electrical signals sensed by electrode combinations and stimulation parameter values. As shown in the example of FIG. 10, user interface 400 includes screen 1002 that shows different sensed information in field 1010. Duration input 1004 can be used to set the length of data on the x-axis in field 1010. Spectrograph 1012 may provide data of the power of different frequencies over time. Line graph 1014 may show traces of the power of different respective frequencies indicated in key 1016. Parameter graph 1018 indicates the parameter value over time, which is shown as amplitude in the example of FIG. 10. The data in field 1010 may be shown in real-time (or near-real time) or stored for later analysis. Frequency boxes 1022 and 1024 can receive user input setting the frequency of the sensed electrical signals to track during sensing. Resume button 1020 can restart, or pause, sensing in response to being selected by the user.

[0103] Stimulation parameter values can also be changed in screen 1002. Slider 430 indicates the current parameter value (e.g., amplitude, pulse width, or frequency). Upper limit 1030 and lower limit 1032 set the range for the parameter value. Upper threshold 1034 and lower threshold 1036 indicate the range for the sensed electrical signal (e.g., LFP at a particular frequency) that cause the system to automatically reduce or increase the stimulation parameter value to try and retain the sensed signal within those thresholds. In some examples, the calculated VNA can be used as a threshold for closed-loop stimulation. For example, stimulation ramping and / or adjustments may be limited to VNA limits such as percentages outside of the target structure.

[0104] FIGS. 11 and 12 are conceptual diagrams illustrating examples visualizations of anatomical structures and sensing quality from respective electrode combinations. As shown in the example of FIG. 11, visualization 1102 provides anatomical structure 1108 together with dots 1110 that indicate the signal quality at different locations. Visualization 1104 is a rotate view from visualization 1102. Legend 1106 indicates the signal quality at each location with a color indicator correlating with the number of dots for each location as shown in FIGS. 4 and 5. FIG. 12 is another example of visualizations 1202 and 1204 which are similar to those of FIG. 11. However, visualizations 1202 and 1204 include binary indicators 1210 that only indicate if a location is good or bad. Dots 1110 and visualizations 1202 and 1204 can provide a visualization of aggregate sensing data for different electrode combinations from the patient or from manyDocket No.: A0013320W001 / 1123-866W001 patients. The dots or binary indicators of each graph can create something similar to a “heat map” that can indicate likely locations for efficacious stimulation therapy for the patient.

[0105] In this manner, sensing results can also be displayed in aggregate using a “common” STN, which is a model anatomical region that is averaged across all patients or modeled from past imaging data. Aggregate displays such as visualizations 1102 and 1104 can include dots 1108 (e.g., scores that have multi-scale or simplified to binary indicators) based on LFP sensed signals or ERNA characteristics. In addition, or alternative, to dots, the system may create a heat map in two or three dimensions that can indicate likely locations of higher signal quality or more efficacious stimulation therapy. In other words, these likely locations may represent a recommended area for implanting electrodes and / or selecting electrode combinations that can deliver stimulation (e.g., create a VNAto cover these areas).

[0106] FIG. 13 is a conceptual diagram illustrating example visualizations of anatomical structures and target stimulation areas based on sensed signals and volume of neural activation (VNA). As shown in the example of FIG. 13, visualizations 1302, 1322, and 1342 provide different ways to indicate target locations based on sensed data and / or VNA information. Visualization 1302 indicates that dots 1310 can indicate signal strength at different locations with respect to anatomical structure 1308 and calculate a target stimulation area 1306. Similarly, visualization 1332 provides the dot score of dots 1330 and corresponding target stimulation area 1326. The score of dots 1330 may correspond to post-processed sensing data from monopolar sensing data for each electrode. Visualization 1342 provides different VNAs 1350 from different electrode combinations and provides a target stimulation area 1346. In some examples, dots and VNAs may be overlaid on each other or otherwise presented in the same view for visual correlation.

[0107] In this manner, the aggregate display could include a region or blob based on sensed data in some examples. This area could be used to show the target stimulation area (e.g., a “sweet spot”) for stimulation. This area could be based on post-processed results or dot scores. In some examples, the aggregate “sweet spot” could be based on VNA recommended from streaming data. In some examples, the “Sweet spot” could be based on statistics (average, median, etc.), modeling / mapping (interpolation, probability, etc.). Although FIG. 13 shows possible target stimulation areas based on the sensed signals, similar visualizations may be generated based on aggregated programming data (e.g., values of one or more stimulation parameters) and / or illustrate possible programming data (e.g., different parameter values) for various locations with respect to the anatomical structures in the diagram.Docket No.: A0013320W001 / 1123-866W001

[0108] FIGS. 14A and 14B are graphs of stimulation characteristics based on stimulation parameters selected using different methods. As shown in the example of FIG. 14A, different programming methods 1402 and 1404 were used to generate stimulation parameters. In particular, method 1404 used the techniques described herein where sensed signal information (e.g., signal quality) is used together with other information such as anatomical information. Generally, the maximum amplitude of stimulation using either method 1402 or 1404 were generally the same. However, as shown in FIG. 14B, method 1404 resulted in a greater percentage of the VNA from stimulation being within the target anatomical structure, which was the STN in this example. This data indicates that combining sensed signal information with imaging or other information can result in improved therapy efficacy.

[0109] FIG. 15 is a flow diagram of an example technique for generating information on a user interface, in accordance with one or more techniques of this disclosure. The example technique of FIG. 15 is discussed in relation to the components of programmer 14 of FIG. 3, IMD 16 of FIG. 2, as well as screen 502 of FIG. 4, but may be used with any of the devices, circuitry, components, or combination thereof, described in this disclosure.

[0110] In the example of FIG. 15, processing circuitry 80 receives signal information for at least one electrode of a plurality of electrodes of IMD 16 (1500). Processing circuitry 80 can then generate, for presentation on a screen, such as screen 502, a representation of one or more signals sensed via at least one or more electrode (1502). This representation of signals may be flags, heat maps, etc. Processing circuitry 80 can then generate, for presentation on the screen of the user interface, a representation of an anatomical structure of the patient with respect to a representation of the at least some electrodes of the plurality of electrodes (1504). Processing circuitry 80 can then receive, via user interface 400, user input adjusting one or more parameters of electrical stimulation (1506) and then control delivery of electrical stimulation according to the one or more parameters (1508).[OHl] The following examples are described herein.

[0112] Example 1. A system comprising: a memory configured to store instructions defining a user interface; processing circuitry coupled to the memory and the telemetry circuitry, the processing circuitry being configured to: receive signal information representing one or more signals sensed via at least one electrode of a plurality of electrodes of an implantable medical device (IMD); generate, for presentation via a screen of the user interface, a representation of the one or more signals sensed via the at least one electrode; and generate, for presentation via the screen of the user interface, a representation of an anatomical structure of the patient with respect to a representation of at least some electrodes of the plurality of electrodes.Docket No.: A0013320W001 / 1123-866W001

[0113] Example 2. The system of example 1, wherein the processing circuitry is configured to generate the representation of the one or more signals by at least generating, for presentation via the first screen of the user interface, an indication of signal quality based on the received signal information for each electrode of the plurality of electrodes, wherein the indication of signal quality corresponds to at least one frequency band on the frequency spectrum.

[0114] Example 3. The system of any of examples 1 or 2, wherein the indication of signal quality comprises a color-based or graphical representation of the signal information.

[0115] Example 4. The system of any of examples 1 through 3, wherein the indication of signal quality comprises a plurality of markers, and wherein the processing circuitry is configured to control the user interface to present, for each electrode of the at least one electrode, graphical representation of the plurality of markers spatially correlated with a respective electrode of the at least one electrode presented on the screen.

[0116] Example 5. The system of any of examples 1 through 4, wherein the indication of signal quality for the at least one electrode of the plurality of electrodes indicates one or more recommended electrodes for electrical stimulation therapy.

[0117] Example 6. The system of any of examples 1 through 5, wherein the representation of the one or more signals comprises an indication of at least one of: activity of local field potentials (LFPs) within at least one frequency band, strength of an evoked potential, or strength of an evoked resonance neural activity (ERNA) signal.

[0118] Example 7. The system of any of examples 1 through 6, wherein the processing circuitry is configured to: determine the representation of the one or more signals by at least determining, based on the one or more signals, a target stimulation area; and generate, for presentation via the screen of the user interface, a representation of the target stimulation area together with the representation of the anatomical structure of the patient.

[0119] Example 8. The system of any of examples 1 through 7, wherein the processing circuitry is configured to determine a volume of activation resulting from stimulation deliverable via one or more electrodes of the plurality of electrodes; and control the user interface to present the volume of activation together with the representation of the anatomical structure.

[0120] Example 9. The system of any of examples 1 through 8, wherein the plurality of electrodes comprises at least one segmented electrode that is disposed at a partial perimeter around a lead.

[0121] Example 10. The system of any of examples 1 through 9, wherein the signal information comprises information representative of electrical signals including local field potentials (LFPs).Docket No.: A0013320W001 / 1123-866W001

[0122] Example 11. The system of any of examples 1 through 10, wherein the processing circuitry is configured to control the IMD to execute a test to control the IMD to sense electrical signals from a plurality of electrode combinations, each of the plurality of electrode combinations comprising a same reference electrode of the plurality of electrodes and at least one different sense electrode of the plurality of electrodes, wherein the user interface is configured to receive input from a user to perform the test on the IMD, and wherein the processing circuitry is further configured to: obtain, from the user, an indication to perform the test on the IMD; and obtain, via the telemetry circuitry, results of the test.

[0123] Example 12. The system of any of examples 1 through 11, wherein the processing circuitry is configured to program, via the telemetry circuitry, the IMD to provide electrical stimulation therapy according to a stimulation therapy program, the stimulation therapy program defining an electrode combination for deep brain stimulation (DBS) therapy based on the one or more signals for each electrode of the plurality of electrodes, and wherein the processing circuitry is configured to adjust the stimulation therapy program based on the one or more signals sensed via the at least one electrode of the plurality of electrodes.

[0124] Example 13. The system of any of examples 1 through 11, further comprising the screen configured to display the representation of the one or more signals sensed via the at least one electrode and the representation of the anatomical structure of the patient with respect to the representation of at least some electrodes of the plurality of electrodes.

[0125] Example 14. The system of example 13, further comprising an external programmer comprising the memory, the processing circuitry, and the screen.

[0126] Example 15. A method comprising: receiving, by processing circuitry, signal information representing one or more signals sensed via at least one electrode of a plurality of electrodes of an implantable medical device (IMD); generating, by the processing circuitry, for presentation via a screen of the user interface, a representation of the one or more signals sensed via the at least one electrode; and generating, by the processing circuitry, for presentation via the screen of the user interface, a representation of an anatomical structure of the patient with respect to a representation of at least some electrodes of the plurality of electrodes.

[0127] Example 16. The method of example 15, wherein generating the representation of the one or more signals comprises generating, for presentation via the first screen of the user interface, an indication of signal quality based on the received signal information for each electrode of the plurality of electrodes, wherein the indication of signal quality corresponds to at least one frequency band on the frequency spectrum.Docket No.: A0013320W001 / 1123-866W001

[0128] Example 17. The method of any of examples 15 or 16, wherein the indication of signal quality comprises a color-based or graphical representation of the signal information.

[0129] Example 18. The method of any of examples 15 through 17, wherein the indication of signal quality comprises a plurality of markers, and wherein the method comprises controlling the user interface to present, for each electrode of the at least one electrode, graphical representation of the plurality of markers spatially correlated with a respective electrode of the at least one electrode presented on the screen.

[0130] Example 19. The method of any of examples 15 through 18, wherein the indication of signal quality for the at least one electrode of the plurality of electrodes indicates one or more recommended electrodes for electrical stimulation therapy.

[0131] Example 20. The method of any of examples 15 through 19, wherein the representation of the one or more signals comprises an indication of at least one of: activity of local field potentials (LFPs) within at least one frequency band, strength of an evoked potential, or strength of an evoked resonance neural activity (ERNA) signal.

[0132] Example 21. The method of any of examples 15 through 20, further comprising: determining the representation of the one or more signals by at least determining, based on the one or more signals, a target stimulation area; and generating, for presentation via the screen of the user interface, a representation of the target stimulation area together with the representation of the anatomical structure of the patient.

[0133] Example 22. The method of any of examples 15 through 21, further comprising: determining a volume of activation resulting from stimulation deliverable via one or more electrodes of the plurality of electrodes; and controlling the user interface to present the volume of activation together with the representation of the anatomical structure.

[0134] Example 23. The method of any of examples 15 through 22, wherein the plurality of electrodes comprises at least one segmented electrode that is disposed at a partial perimeter around a lead.

[0135] Example 24. The method of any of examples 15 through 23, wherein the signal information comprises information representative of electrical signals including local field potentials (LFPs).

[0136] Example 25. A non-transitory computer-readable medium comprising instructions that, when executed, cause processing circuitry to: receive signal information representing one or more signals sensed via at least one electrode of a plurality of electrodes of an implantable medical device (IMD); generate, for presentation via a screen of the user interface, a representation of the one or more signals sensed via the at least one electrode; and generate, forDocket No.: A0013320W001 / 1123-866W001 presentation via the screen of the user interface, a representation of an anatomical structure of the patient with respect to a representation of at least some electrodes of the plurality of electrodes.

[0137] The techniques described in this disclosure, including those attributed to IMD 16, programmer 14, or various constituent components, may be implemented, at least in part, in hardware, software, firmware or any combination thereof. For example, various aspects of the 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 circuitry, as well as any combinations of such components, embodied in programmers, such as clinician or patient programmers, medical devices, or other devices.

[0138] In one or more examples, the functions described in this disclosure may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored, as one or more instructions or code, on a computer- readable medium and executed by a hardware-based processing unit. Computer-readable media may include computer-readable storage media forming a tangible, non-transitory medium. 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 circuitry. Accordingly, the term “processor,” as used herein may refer to one or more of any of the foregoing structures or any other structure suitable for implementation of the techniques described herein.

[0139] In addition, in some respects, the functionality described herein may be provided within dedicated hardware and / or software modules. Depiction of different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be realized by separate hardware or software components. Rather, functionality associated with one or more modules or units may be performed by separate hardware or software components or integrated within common or separate hardware or software components. Also, the techniques may be fully implemented in one or more circuits or logic elements. The techniques of this disclosure may be implemented in a wide variety of devices or apparatuses, including an IMD, an external programmer, a combination of an IMD and external programmer, an integrated circuit (IC) or a set of ICs, and / or discrete electrical circuitry, residing in an IMD and / or external programmer.

Claims

Docket No.: A0013320W001 / 1123-866W001WHAT IS CLAIMED IS:

1. A system comprising: a memory configured to store instructions defining a user interface; processing circuitry coupled to the memory and the telemetry circuitry, the processing circuitry being configured to: receive signal information representing one or more signals sensed via at least one electrode of a plurality of electrodes of an implantable medical device (IMD); generate, for presentation via a screen of the user interface, a representation of the one or more signals sensed via the at least one electrode; and generate, for presentation via the screen of the user interface, a representation of an anatomical structure of the patient with respect to a representation of at least some electrodes of the plurality of electrodes.

2. The system of claim 1, wherein the processing circuitry is configured to generate the representation of the one or more signals by at least generating, for presentation via the first screen of the user interface, an indication of signal quality based on the received signal information for each electrode of the plurality of electrodes, wherein the indication of signal quality corresponds to at least one frequency band on the frequency spectrum.

3. The system of any of claims 1 or 2, wherein the indication of signal quality comprises a color-based or graphical representation of the signal information.

4. The system of any of claims 1 through 3, wherein the indication of signal quality comprises a plurality of markers, and wherein the processing circuitry is configured to control the user interface to present, for each electrode of the at least one electrode, graphical representation of the plurality of markers spatially correlated with a respective electrode of the at least one electrode presented on the screen.

5. The system of any of claims 1 through 4, wherein the indication of signal quality for the at least one electrode of the plurality of electrodes indicates one or more recommended electrodes for electrical stimulation therapy.Docket No.: A0013320W001 / 1123-866W0016. The system of any of claims 1 through 5, wherein the representation of the one or more signals comprises an indication of at least one of: activity of local field potentials (LFPs) within at least one frequency band, strength of an evoked potential, or strength of an evoked resonance neural activity (ERNA) signal.

7. The system of any of claims 1 through 6, wherein the processing circuitry is configured to: determine the representation of the one or more signals by at least determining, based on the one or more signals, a target stimulation area; and generate, for presentation via the screen of the user interface, a representation of the target stimulation area together with the representation of the anatomical structure of the patient.

8. The system of any of claims 1 through 7, wherein the processing circuitry is configured to determine a volume of activation resulting from stimulation deliverable via one or more electrodes of the plurality of electrodes; and control the user interface to present the volume of activation together with the representation of the anatomical structure.

9. The system of any of claims 1 through 8, wherein the plurality of electrodes comprises at least one segmented electrode that is disposed at a partial perimeter around a lead.

10. The system of any of claims 1 through 9, wherein the signal information comprises information representative of electrical signals including local field potentials (LFPs).

11. The system of any of claims 1 through 10, wherein the processing circuitry is configured to control the IMD to execute a test to control the IMD to sense electrical signals from a plurality of electrode combinations, each of the plurality of electrode combinations comprising a same reference electrode of the plurality of electrodes and at least one different sense electrode of the plurality of electrodes, wherein the user interface is configured to receive input from a user to perform the test on the IMD, and wherein the processing circuitry is further configured to: obtain, from the user, an indication to perform the test on the IMD; and obtain, via the telemetry circuitry, results of the test.Docket No.: A0013320W001 / 1123-866W00112. The system of any of claims 1 through 11, wherein the processing circuitry is configured to program, via the telemetry circuitry, the IMD to provide electrical stimulation therapy according to a stimulation therapy program, the stimulation therapy program defining an electrode combination for deep brain stimulation (DBS) therapy based on the one or more signals for each electrode of the plurality of electrodes, and wherein the processing circuitry is configured to adjust the stimulation therapy program based on the one or more signals sensed via the at least one electrode of the plurality of electrodes.

13. The system of any of claims 1 through 11, further comprising the screen configured to display the representation of the one or more signals sensed via the at least one electrode and the representation of the anatomical structure of the patient with respect to the representation of at least some electrodes of the plurality of electrodes.

14. The system of claim 13, further comprising an external programmer comprising the memory, the processing circuitry, and the screen.

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

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