[go: up one dir, main page]

WO2025029593A1 - Interface utilisateur avec résultats de détection d'électrode - Google Patents

Interface utilisateur avec résultats de détection d'électrode Download PDF

Info

Publication number
WO2025029593A1
WO2025029593A1 PCT/US2024/039603 US2024039603W WO2025029593A1 WO 2025029593 A1 WO2025029593 A1 WO 2025029593A1 US 2024039603 W US2024039603 W US 2024039603W WO 2025029593 A1 WO2025029593 A1 WO 2025029593A1
Authority
WO
WIPO (PCT)
Prior art keywords
electrodes
screen
electrode
signal quality
processing circuitry
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/039603
Other languages
English (en)
Inventor
Michelle A. CASE
Scott R. Stanslaski
Caleb C. ZARNS
Nicholas R. UNGER
Todd D. Zenisek
Thomas L. CHOUINARD
Andrew H. Houchins
Stephanie L. SZOLWINSKI
Erik J. Peterson
Karan CHITKARA
Ilan D. GORDON
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtronic Inc
Original Assignee
Medtronic Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medtronic Inc filed Critical Medtronic Inc
Publication of WO2025029593A1 publication Critical patent/WO2025029593A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37235—Aspects of the external programmer
    • A61N1/37247—User interfaces, e.g. input or presentation means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526—Head electrodes
    • A61N1/0529—Electrodes for brain stimulation
    • A61N1/0534—Electrodes for deep brain stimulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36135—Control systems using physiological parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36146—Control systems specified by the stimulation parameters
    • A61N1/36182—Direction of the electrical field, e.g. with sleeve around stimulating electrode
    • A61N1/36185—Selection of the electrode configuration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37235—Aspects of the external programmer
    • A61N1/37241—Aspects of the external programmer providing test stimulations

Definitions

  • ITis application is a PCT Application that claims priority to, and the benefit of, U.S. Provisional Application No. 63/623,001, filed January 19, 2024, and entitled, “USER INTERFACE WITH ELECTRODE SENSING RESULTS,” and U.S. Provisional Application No. 63/516,455, filed July 28, 2023, and entitled, “ELECTRODE SENSING RESULTS INTEGRATED WITH ELECTRODE ASSIGNMENT,” the entire contents of each of Application Nos. 63/623,001 and 63/516,455 are incorporated herein by reference.
  • Tire disclosure relates to medical devices, and more specifically, sensing electrical signals from a patient.
  • 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.
  • 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.
  • therapy may be delivered via particular combinations of the electrodes carried by leads and/or by the housing of the electrical stimulator.
  • 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
  • SUBSTITUTE SHEET (RULE 26) evoked by delivered stimulus such as evoked compound action potential (eCAP) signals or evoked resonant neural response (ERNA) signals.
  • eCAP evoked compound action potential
  • ERNA evoked resonant neural response
  • 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).
  • the system is configured to generate representations of electrodes and information corresponding to the electrodes (e.g., an indication of signal quality, such as LFP magnitudes).
  • the system is configured to generate, for presentation via a user interface, representations of received signal information (e.g., a representation of a LFP signal) over a frequency spectrum on the same screen as the representations of electrodes and information corresponding to the electrodes.
  • Presentation of information in these ways may enable efficient programming workflows for electrical stimulation therapy, e.g., via a user interface, with less user input selections and/or more options available to a user to be accessed from a given screen of the user interface.
  • These features related to the presentation of information and programming efficiency can reduce programming time, reduce human error, and reduce mental burden on clinicians by allowing access to various types of information from one screen.
  • a 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.
  • the processing circuitry is configured to receive, via the telemetry 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); generate, for presentation via a first screen of the user interface, a representation of the received signal information over a frequency spectrum for the at least one electrode of the plurality of electrodes; and generate, for presentation via the first screen of the user interface, a representation of the plurality of electrodes and 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 on the frequency spectrum.
  • IMD implantable medical device
  • a method includes receiving, by processing circuitry via telemetry 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 and for presentation on a first screen of a user
  • IMD implantable medical device
  • SUBSTITUTE SHEET (RULE 26) interface, a representation of the received signal information over a frequency spectrum for the at least one electrode of the plurality of electrodes; and generating, by the processing circu itry and for presentation on the first screen of the user interface, a representation of the plurality of electrodes and 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 on the frequency' spectrum.
  • a computer-readable medium includes instructions that, when executed, control processing circuitry' to recei ve, via telemetry 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); generate, for presen tation on a first screen of a user interface, a representation of the received signal information o ver a frequency spectrum for the at least one electrode of tire plurality of electrodes; and generate, for presentation on the first screen of the user interface, a representation of the plurality of electrodes and 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' on the frequency' spectrum.
  • IMD implantable medical device
  • 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.
  • DBS deep brain stimulation
  • FIG. 2 is functional block diagram illustrating components of an example medical device in accordance with one or more aspects of this disclosure.
  • 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.
  • FIG. 4 is a conceptual diagram illustrating an example user interface lead screen displaying a representation of a lead including a plurality of electrodes in accordance with one or more aspects of this disclosure.
  • FIG. 5 is a conceptual diagram illustrating an example user interface lead screen displaying a representation of a lead including a plurality of electrodes in accordance with one or more aspects of this disclosure.
  • FIG. 6 is a conceptual diagram illustrating an example user interface results screen displaying a lead including a plurality of electrodes and signal information for some of the electrodes in accordance with one or more aspects of this disclosure.
  • FIG. 7 is a conceptual diagram illustrating an example user interface results screen displaying a lead including a plurality of electrodes and signal information for some of the electrodes in accordance with one or more aspects of this disclosure.
  • FIG. 8 is a conceptual diagram illustrating an example user interface screen displaying a prompt for a user to run a test.
  • FIG. 9 is a conceptual diagram illustrating an example user interface results screen displaying a lead including a plurality of electrodes and signal information for some of the electrodes in accordance with one or more aspects of this disclosure.
  • FIG. 10 is a conceptual diagram illustrating an example user interface results screen displaying a lead including a plurality of electrodes and signal information for some of the electrodes in accordance with one or more aspects of this disclosure.
  • FIG. 11 is a conceptual diagram illustrating an example user interface results screen displaying a lead including a plurality of electrodes and signal information for some of the electrodes in accordance with one or more aspects of this disclosure.
  • FIG. 12 is a conceptual diagram illustrating an example user interface results screen displaying a lead including a plurality of electrodes and signal information for some of the electrodes in accordance with one or more aspects of this disclosure.
  • FIG. 13 is a conceptual diagram illustrating an example user interface results screen displaying a lead including a plurality of electrodes and signal information for some of the electrodes in accordance with one or more aspects of this disclosure.
  • FIG. 14 is a conceptual diagram illustrating an example user interface results screen displaying a lead including a plurality of electrodes and signal information for some of the electrodes in accordance with one or more aspects of this disclosure.
  • FIG. 15 is a conceptual diagram illustrating an example user interface screen displaying signal information over a frequency spectrum and indications of signal quality for some of the electrodes in accordance with one or more aspects of this disclosure.
  • FIG. 16 is a conceptual diagram illustrating an example user interface screen displaying signal information over a frequency spectrum and indications of signal quality for some of the electrodes in accordance with one or more aspects of this disclosure.
  • FIG. 17 is a conceptual diagram illustrating an example user interface screen displaying signal information over a frequency spectrum and indications of signal quality for some of the electrodes in accordance with one or more aspects of this disclosure.
  • FIG. 18A is a conceptual diagram illustrating an example user interface screen displaying signal information over a frequency spectrum including raw data.
  • FIG. 18B is a conceptual diagram illustrating an example user interface screen displaying signal information over a frequency spectrum including processed data.
  • FIG. 19A is a conceptual diagram illustrating an example user interface screen that is not displaying indications of signal quality.
  • FIG. 19B is a conceptual diagram illustrating an example user interface screen displaying indications of signal quality for some of the electrodes.
  • FIG. 20 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.
  • 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.
  • parameters are selected and adjusted via a computing device (e.g., a programmer) with a user interface configured to receive user input.
  • a user e.g., a clinician or patient
  • SUBSTITUTE SHEET (e.g., signal information) that is sensed via the electrodes when the electrodes are implanted in a patient.
  • 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.
  • the devices, systems, and techniques of tins disclosure enable display of relevant information for multiple electrodes at the same time (e.g., on a single screen of a user display), which may enable a user (e.g., a clinician or patient) to select or adjust parameters for stimulation therapy more quickly, more efficiently, and/or more accurately.
  • the system may present signal information for multiple electrodes or electrode combinations (e.g., an indication of signal quality, ranking, etc.) while also presenting signal information over a signal frequency spectrum on a single screen of a user interface.
  • signal information for multiple electrodes or electrode combinations e.g., an indication of signal quality, ranking, etc.
  • a user does not need to navigate through multiple screens of a user interface to view relevant electrode information for selecting or adjusting parameters for stimulation therapy.
  • a user does not have to remember or otherwise transcribe information for individual electrodes or electrode combinations for later comparison against information for other electrodes.
  • the system may be configured to automatically update information for electrodes in response to user input (e.g., based on selection of a new frequency within the frequency range, toggle of filtered and unfiltered data, etc.).
  • the system may thus determine updates to information as various criteria related to electrodes changes.
  • the display of relevant information for multiple electrodes on the same screen, which may automatically update in response to user input, may therefore enable more accurate selection and/or adjustment of parameters for stimulation therapy because a user does not need to remember or transcribe relevant electrode information.
  • the devices, systems, and techniques of this disclosure enable efficient programming workflows for electrical stimulation therapy, e.g., via a user interface, with less clicks and/or more options available to a user to be accessed from a given screen of the user interface.
  • the system may present options to view
  • SUBSTITUTE SHEET (RULE 26) different types and/or sets of test results from 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.
  • Parkinson’s Disease is a progressive neuro-degenerative disorder characterized by the depletion of dopaminergic neurons in the basal ganglia-thalamo- cortical network.
  • 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.
  • DBS therapy may be used to deliver electrical stimulation to treat motor symptoms in medication-refractory PD patients.
  • DBS therapy may involve the unilateral or bilateral implantation of one or more leads into the brain to deliver electrical stimulation to target structures m 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.
  • the trial -and-error approach tor determining appropriate electrode combinations and/or other stimulation parameters may subject the patient to undesirable side effects during tins lengthy process and/or may result in less than optimal stimulation parameters, thus lessening the therapeutic value of any therapy delivered.
  • the target region associated with a disease may generate signals of interest (e.g., Beta waves that may be indicative of symptoms such as tremor in PD).
  • signals of interest e.g., Beta waves that may be indicative of symptoms such as tremor in PD.
  • 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).
  • parameters for stimulation may include which electrodes are to be used tor 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.
  • 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.
  • 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 electrodes 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.
  • FFT fast Fourier transform
  • the system may then identify tire 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.
  • the system may recommend the electrode combination associated with stronger Beta waves for targeted stimulation to this region of tissue.
  • Beta waves may be used in some examples, other frequency bands such as frequencies in the gamma band may be selected instead.
  • 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 tire 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
  • SUBSTITUTE SHEET (RULE 26) 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.
  • the indications signal quality and/or recommendation of electrodes may be based on other sensed signals, such as eCAP signals or other evoked responses.
  • the system may provide the summan' information based on tire sensed LFPs, such as via a colored representation, a graphical representation (such as a number of 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.
  • a graphical representation such as a number of dots, a sliding scale, or the like
  • 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 electrode information over a frequency spectrum, wherein the system is configured to automatically update the summary' information when a different frequency' is selected.
  • a clinician may select an electrode combination associated with the stronger (e.g., larger amplitude spectral power) electrode amplitudes associated with Beta waves for subsequent sensing and/or stimulation therapy' on a same screen as viewing the indication of signal quality for the stimulation electrodes.
  • stronger electrode amplitudes associated with Beta waves for subsequent sensing and/or stimulation therapy' on a same screen as viewing the indication of signal quality for the stimulation electrodes.
  • 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 gi ven 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).
  • 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.
  • 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
  • SUBSTITUTE SHEET (RULE 26) between cathodes and anodes and improve sensing fidelity.
  • 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.
  • Sensing electrical signals between different electrodes 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.
  • 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)
  • the system or a clinician may use this information to determine which electrodes (and/or oilier 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.
  • 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
  • the gamma band may refer to a frequency band greater than 30 Hz.
  • 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.
  • bipolar sensing may be susceptible to electrocardiogram artifacts which may result in noisy sensed electrical signals, further complicating the stimulation electrode selection process.
  • a clinician may perform a review' to test each electrode and the effect of stimulating using
  • FIG. l 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-mammahan non-human patients.
  • therapy system 10 includes medical device programmer 14, implantable medical device (IMD) 16, lead extension 18, and one or more leads 20A 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.
  • 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, 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.
  • seizure disorders e.g., epilepsy
  • MMDD major depressive disorder
  • bipolar disorder e.g., anxiety disorders, post-traumatic stress disorder, dysthymic disorder, and obsessive compul
  • 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
  • SUBSTITUTE SHEET (RULE 26) 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 circuits 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.
  • 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.
  • 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.
  • leads 20 are implanted endovascularly (e.g., within blood vessel) adjacent a target region of brain 28,
  • 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 2.4 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 electrical stimulation to target therapy delivery’ sites within brain 28 during treatment.
  • 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.
  • 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.
  • electrodes 24A, 24D, 26A, and 261) 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.
  • 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, m other examples, by multiple electrodes located at different positions around the perimeter of the lead.
  • electrodes 24B, 24C, 2.6B, 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.
  • 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.
  • 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.
  • the electrodes may be pad electrodes, that may be carried on a paddle lead or a cylindrical lead.
  • the set of electrodes 24 of lead 20A may include electrodes 24A, 24B, 24C, and 24D, and the set of electrodes 26 of lead 20B
  • SUBSTITUTE SHEET may include electrodes 26A, 26B, 26C, and 26D.
  • each of electrodes 24 and 26 may be configured to independently deliver electrical stimulation.
  • 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.
  • 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.
  • 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.
  • 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.
  • therapy sy stem 10 may be configured to sense bioelectrical brain signals or another physiological parameter of patient 12.
  • 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.
  • 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.
  • IMD 16 may also use a separate set of sensing electrodes to sense the bioelectrical brain signals.
  • 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.
  • one or more of electrodes 24 and/or electrodes 26 ma_v 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.
  • 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.
  • 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.
  • 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 allo w ed by the clinician programmer to prevent an untrained patient from making undesired changes to IMD 16.
  • 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).
  • 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.
  • 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 butons and a keypad, the buttons may be
  • 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,
  • programmer 14 may be a larger workstation or a separate application within another multi-function device, rather than a dedicated computing device.
  • the multi -function device may be a notebook computer, tablet computer, workstation, 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.
  • programmer 14 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).
  • 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.
  • the physician may select an electrode combination for deliver ⁇ ' 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
  • SUBSTITUTE SHEET (RULE 26) electrodes providing the largest LFP spectral power to provide therapy to patient 12 to address symptoms associated with the patient condition.
  • Programmer 14 may also be configured for use by patient 12. When configured as a patient programmen 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.
  • programmer 14 is configured to communicate with IMD 16 and, optionally, another computing device, via wireless communication.
  • Programmer 14 may communicate via wireless communication with IMD 16 using radio frequency (RF) and/or inductive telemetry techniques that may comprise techniques for proximal, mid-range, or longer- range communication.
  • RF radio frequency
  • 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 802.1 1 or Bluetooth specification sets, infrared (IR) communication according to the Infrared Data Association (IRDA) specification set, or other standard or proprietary telemetry protocols.
  • RF radio frequency
  • IR infrared
  • IRDA Infrared Data Association
  • 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.
  • PAN personal area network
  • LAN local area network
  • WAN wide area network
  • PSTN public switched telephone network
  • cellular telephone network for example.
  • 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. Tire 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
  • SUBSTITUTE SHEET (RULE 26) obtain acute recordings during lead placement and before coupling the lead with an IMD.
  • an external device e.g., an external electrophysiology system
  • 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.
  • a clinician may select electrodes to deliver stimulation that did not sense the largest LFP 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.
  • a clinician may select values for therapy parameters for therapy system 10, including an electrode combination to be used as stimulation electrodes.
  • 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.
  • 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.
  • 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
  • the patient feedback may be used to determine a clinical rating scale score.
  • 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 m the creation/identification of therapy programs by providing a methodical system of identifying potentially beneficial therapy parameters.
  • 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).
  • 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.
  • an indication of a signal quality e.g., ranking or rating based on LFP signal magnitude
  • an indication of a signal quality e.g., ranking or rating based on LFP signal magnitude
  • 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).
  • 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
  • SUBSTITUTE SHEET (RULE 26) 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.
  • 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.
  • 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.
  • 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.
  • IMD 16 may be configured to deliver electrical stimulation to the particular patient via the clinician selected electrode combination.
  • the clinician may select the therapy to deliver electrical stimulation to the particular patient via the selected electrode combination.
  • 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.
  • 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.
  • a clinician may’ utilize the sensed electrical signals to select, the stimulation electrodes to be used for a given therapy program.
  • 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
  • SUBSTITUTE SHEET (RULE 26) 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 tor those respective 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.
  • 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 first screen of the a user interface, a representation of the received signal information over a frequency spectrum for the at least one electrode of electrodes 24 and/or electrodes 26 of IMD 16. In some examples, programmer 14 generates, for presentation via the first 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 the indication of signal quality corresponds to at least one frequency on the frequency spectrum.
  • FIG. 2 is functional block diagram illustrating components of an example IMD 16.
  • 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 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.
  • RAM random-access memory'
  • ROM read only memory/
  • NVRAM non-volatile RAM
  • EEPROM electrically erasable programmable ROM
  • 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.
  • 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 memoiy 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 tor monitoring brain signals within one or more brain regions via electrodes 24 and/or electrodes 26 and delivering electrical stimulation therapy to patient 12.
  • 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.
  • 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.
  • 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.
  • 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 deliver electrical stimulation based on input from a user, such as a clinician.
  • 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.
  • 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
  • SUBSTITUTE SHEET (RULE 26) programs 74 are chosen at programmer 14 and/or an external computer and transferred to IMD 16 and stored in memory 62.
  • therapy programs 74 are chosen at programmer 14 and/or an external computer and transferred to IMD 16 and stored in memory 62.
  • fired 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.
  • Tire processors or processing circuit ry 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.
  • DSPs digital signal processors
  • ASICs application specific integrated circuits
  • FPGAs field programmable logic arrays
  • 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.
  • the set of electrodes 24 of lead 20A includes electrodes 24A-24D
  • the set of electrodes 26 of lead 20B includes electrodes 26 A-
  • 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.
  • 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).
  • interface 68 may include switch circmtn 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.
  • 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 24 and/or electrodes 26 and to selectively sense bioelectrical brain signals with selected electrodes 24 and/or electrodes 26.
  • 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.
  • stimulation generator 64 is
  • SUBSTITUTE SHEET (RULE 26) coupled to electrodes 24 and/or electrodes 26 via interface 68 and conductors within leads 20.
  • 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.
  • the selected electrode combination may be monopolar.
  • one or more electrodes e.g., one or more cathodes
  • the oilier electrode e.g., an anode
  • the spacing between sensing electrodes may be greater than 30 mm from the spatial extent of the signal source (e.g., 3 - 9 mm).
  • the reference electrode may be located on a burr hole cap, be coupled to the burr hole cap, or located elsewhere in the body.
  • 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 m 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.
  • a bipolar selected combination may include two electrodes from electrodes 24, where one is an anode and the other is a cathode.
  • a bipolar selected combination may include two electrodes from electrodes 26, where one is an anode and the other is a cathode.
  • 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.
  • a multipolar selected combination may include multiple anodes and/or multiple cathodes selected from electrodes 24.
  • a multipolar selected combination may include multiple anodes and/or multiple cathodes selected from electrodes 26.
  • a multipolar selected combination may include multiple anodes and/or multiple cathodes selected from electrodes 24 and electrodes 26.
  • Stimulation generator 64 may be a single channel or multi-channel stimulation generator.
  • 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.
  • stimulation generator 64 and interface 68 may be configured to deliver multiple channels on a time-interleaved basis.
  • 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.
  • 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 2.6 (and/or a reference other than an electrode of electrodes 24 and/or electrodes 26).
  • 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.
  • 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.
  • SUBSTITUTE SHEET (RULE 26) circuitiy in other devices and systems described herein, such as programmer 14, may accomplish communication by RF communication techniques.
  • 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 to external programmer 14 on a continuous basis, at periodic intervals, or upon request from IMD 16 or programmer 14.
  • Power source 72 delivers operating powerto 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 energyscavenging device to trickle charge a rechargeable battery. In other examples, traditional batteries may' be used for a limited period of time.
  • FIG. 3 is a functional block diagram illustrating components of an example medical device programmer.
  • 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 circuit ry .
  • 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.
  • 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.
  • 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
  • a keypad e.g., an alphanumeric keypad
  • a peripheral pointing device e.g., a mouse, rollerball, joystick, or the like
  • SUBSTITUTE SHEET 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.
  • 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.
  • the collection of screens 89 of graphical information that is presented on display 83 may be referred to as a user interface.
  • display 83 may include a touch-sensitive input device 90 alone or in addition to one or more oilier input devices 90 separate from display 83.
  • Memory 82 may include instructions for operating user interface 86 and telemetry circuitiy 84, and for managing power source 88.
  • 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.
  • 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 of IMD 16 may transmit tire sensed electrical signals to programmer 14 via telemetry' circuitiy- 70 and processing circuitry' 80 may- determine the respective indications of signal quality.
  • processing circuitry- 60 e.g., before transmission
  • processing circuitry 80 after receipt
  • processing circuitiy' 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.
  • 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.
  • screen(s) 89 may include a segments programming screen and a levels programming screen for a given lead.
  • 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
  • a levels 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 level, such as where segmented electrodes are functioning as virtual ring electrodes.
  • indications of signal quality for both segments and levels are shown simultaneously on screen(s) 89.
  • processing circuitry' 80 may store the sensed electrical signals in results 92.
  • processing circuitry- 80 may store sensed electrical signals from a plurality of different programming sessions over time m results 92, This would pennit a clinician to review stored sensed electrical signals over time to monitor or assess disease progression, lead migration, shorts, damaged electrodes, or the like.
  • results 92 may alternatively or additionally be stored on a server, such as a web service server or a hospital server.
  • 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 overtime. 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.
  • patient 12 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, transmi t the new programs to IMD 16, or any combination thereof.
  • processing circuitry 80 may also be
  • SUBSTITUTE SHEET (RULE 26) 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • programmer 14 may be directly coupled to an alternating current outlet to operate.
  • SUBSTITUTE SHEET (RULE 26)
  • memory 82 of programmer 14 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).
  • FIG. 4 is a conceptual diagram illustrating an example user interface lead screen 400 displaying a representation of a lead 402 including plurality of electrodes in accordance with one or more aspects of this disclosure.
  • Screen 400 may be a screen of screen(s) 89.
  • Processing circuitry 80 may cause display 83 to display, or present, screen 400 on display 83.
  • Screen 400 includes a representation of lead 402.
  • Representation of lead 402 includes representations of a plurality of electrodes 404, labeled 0, la, lb, 1c, 2a, 2b, 2c, and 3.
  • the representations of the electrodes labeled la, lb, 1c, 2a, 2b, and 2c may be represented separately (representation 406) from representation of lead 402 as shown (e.g., in addition to or in lieu of representing such leads on representation of lead 402) as electrodes labeled la, lb, 1c, 2a, 2b, and 2c may include segmented electrodes and some of segmented electrodes la, lb, 1c, 2a, 2b, and 2c may be on a back side of the lead represented by representation of lead 402 and therefore un viewable on representation of lead 402.
  • electrode 3 and electrode 0 of lead 404 remain shown on lead 402, electrode 0 and electrode 3 may be shown together with the rest of the electrodes in representation 406 in other examples
  • Screen 400 also includes a description 410 of the type of therapy program, name and/or identification (ID) of the patient for which the therapy program is being generated .
  • Screen 400 also may include an interface 412 from which one of a plurality of screens may be selected.
  • screen 400 includes the Lead screen which is selected from the options including Lead, Annotation, and BrainSense provided in interface 412,
  • the Annotation screen may be selected to cause the system to provide a user, such as a clinician a screen upon which to make and/or review' annotations relating to the therapy program.
  • the BrainSense screen may be selected to cause the system to provide a review of test results, such as sensed electrical signals, and/or to send a command to IMD 16 to executed electrode selection algorithm 78 to conduct, a test to capture sensed electrical signals.
  • Screen 400 also includes a description 420 indicating which lead is selected and program is selected.
  • lead (Left SIN) is represented by representation of lead 402 and which therapy program the user is currently setting up or viewing (Program 1 ).
  • Screen 400 may also include an interface, such as icon 430, which may be selectable by a user to perform an action, such as open a drop-down menu with one or more selectable options to view various data associated with the electrodes, for example.
  • screen 400 includes an option to view more than one lead and/or hemisphere on the screen (e.g., to include leads for both left and right hemispheres on the same screen).
  • screen 400 can also include one or more other buttons, toggles, window's, or other interfaces for presenting information to a user and/or for receiving user input.
  • screen 400 includes a box or window to indicate system alerts, warning, or failures, such as problems with electrodes 24 and or electrodes 26.
  • FIG. 5 is a conceptual diagram illustrating the example user interface lead screen of FIG. 4 including a dropdown menu in accordance with one or more aspects of this disclosure.
  • Screen 500 may be a screen of screen(s) 89.
  • Processing circuitry 80 may cause display 83 to display screen 500 on display 83.
  • display 83 For example, when a user selects icon 430 of FIG. 4, processing circuitry 80 may cause display 83 to display screen 500 on display 83.
  • a drop-down menu 502. appears.
  • drop down menu 502 may include an Interface to select the viewing of the indications of signal quality, such as results showing indications of signal quality (e.g., View Monopolar Results), and an interface to view' the more detailed test results, such as a graph of the sensed electrical signals (e.g., BrainSense Survey w'hich may include details related to sensed signals, a graph of signal power versus frequency for each electrode, etc.), and/or to send a command to IMD 16 to executed electrode selection algorithm 78 to conduct a test to capture sensed electrical signals.
  • the interface to select the viewing of the indications of signal quality test results may not be operable or displayed.
  • the interface to select the viewing of the indications of signal quality test results may be operable to provide a recommendation that the user have a test conducted and may provide an interface to directly select the option to perform the test, thereby causing processing
  • SUBSTITUTE SHEET (RULE 26) circuitiy 80 to communicate to IMD 16, via telemetry circuitry 84, to execute electrode selection algorithm 78 and conduct a test, such as a monopolar sensing test.
  • FIG. 6 is a conceptual diagram illustrating an example user interface results screen displaying a lead including a representation of a plurality of electrodes and an indication of signal quality based on received signal information for electrodes in accordance with one or more aspects of this disclosure.
  • Screen 600 may be a screen of screen(s) 89 and include screen 500 with a child window 610 overlaid over screen 500.
  • Processing circuitry 80 may cause display 83 to display screen 600 on display 83. For example, when a user selects “View Monopolar Results’’ from drop-down menu 502. of FIG, 5, processing circuitry’ 80 may cause display’ 83 to display screen 600 on display’ 83.
  • Screen 600 may display indication of signal quality 602 for one or more electrodes, including a color-based representation and/or graphical representation of a ranking (or level) for each of segmented electrodes la, lb, 1c, 2a, 2b, and 2c.
  • Screen 600 may display each respective indication of signal quality 602. overlaid with the representation of the respective electrode of the plurality of electrodes.
  • indication of signal quality 602 indicates one or more recommended electrodes for electrical stimulation therapy’ (e.g., electrodes that have a higher relative indication of signal quality).
  • the indications of signal quality 602 may be based on LFP magnitude, or another suitable signal parameter.
  • indications of signal quality may also be provided for electrodes 3 and 0, similar to the other electrodes la, lb, 1c, 2a, 2b, and 2c.
  • Screen 600 may also include a selected frequency (e.g,, 23,82 Hz) which may represent a frequency of sensed electrical signals upon which the indication of signal quality 602 are based (e.g., which may be a recommended frequency).
  • the selected frequency may be a frequency band that includes a specified range of frequencies (e.g., which may be a range of recommended frequencies). This specified range of frequencies may include the frequencies associated with stronger signals above a threshold or otherwise are intended to be used for sensing subsequent powers of sensed signals.
  • each indication of signal quality 602 may be displayed in a graphical form (shown as circles, also referred to herein as dots). For example, a greater number of circles that are filled m corresponds to a higher relative electrode ranking (e.g., better signal quality).
  • the indications of signal quality 602 may be color-based (e.g., represented by color). For example, the
  • SUBSTITUTE SHEET (RULE 26) circles may be filled in with colors representative of the level of signal quality to further distinguish a higher rating or ranking from a lower rating or ranking. For example, if all three circles are filled in (such as corresponding to segmented electrodes la and lb), these circles may be filled in with a green color to indicate a high rating or relative ranking, while the two circles of segmented electrodes 1c, 2a, and 2b may be filled in with a different color (e.g., yellow, orange, gold, white, dark gray) to indicate a medium rating or relative ranking, and the one circle of segmented electrode 2c may be filled in with yet another color (e.g., red, light gray) to indicate a low rating or relative ranking.
  • the entire representation of the segmented electrode may be colored to represent a respective indication of signal quality (e.g., a respective ranking or rating). Different shapes, colors, or numbers of indicators may be used for the electrodes in other examples.
  • the representations of electrodes as shown in FIG. 6, including representation of segmented electrodes l a, lb, 1c, 2a, 2b, and 2c may be selectable, e.g., to cause screen 600 to display further information about the segmented electrodes and/or for selection of the particular electrodes for therapy.
  • processing circuitry 80 may cause display 83 to highlight or encircle the representation of one or more electrodes and provide further options to confirm the selection of electrodes for therapy.
  • a user may select as stimulation electrodes all of segmented electrodes la, lb, and/or 1 c and electrode 0, or some subset of those electrodes.
  • a user may select any combination of electrodes as stimulation electrodes.
  • Die indications of signal quality 602 represented in screen 600 may guide the user in selecting which electrodes should be the stimulation electrodes.
  • Screen 600 may include a button to cancel the selected electrodes and a button to update or save the selected electrodes as stimulation electrodes.
  • FIG. 7 is a conceptual diagram illustrating another example user interface results screen displaying a lead including a representation of a plurality of electrodes and respective indications of signal quality based on received signal information for electrodes in accordance with one or more aspects of this disclosure.
  • Screen 700 may be a screen of screen(s) 89 and include screen 500 with a child window 710 overlaid over screen 500.
  • Processing circuitry 80 may cause display 83 to display screen 700 on display 83. For example, if a user selects ‘"Levels” from screen 600, processing circuitry 80 may
  • SUBSTITUTE SHEET cause display 83 to display screen 700 on display 83.
  • Screen 700 may differ from screen 600 in that the representations of any segmented electrodes may be displayed as virtual ring electrodes which make up a single “level” or axial position along the lead. Indications of signal quality 702 may be displayed on screen 700 in a similar manner to those described with respect to screen 600, however, screen 600 may not display representations of each of the segmented electrodes as any segmented electrodes represented in screen 700 are acting as virtual ring electrodes (e.g., all segmented electrodes at the same axial location are operated together as a single electrode). [01081 FIG.
  • Screen 800 is a conceptual diagram illustrating an example landing screen including a prompt for a user to ran a test according to one or more aspects of this disclosure.
  • Screen 800 may be a screen of screen(s) 89.
  • Processing circuitry 80 may cause display 83 to display screen 800 on display 83.
  • display 83 For example, when a user selects “BrainSense Survey” from drop-down menu 502 of FIG. 5, processing circuitry 80 may cause display 83 to display screen 800 on display 83.
  • Screen 800 includes a window 810 displaying a message or prompt (e.g., which may include a “Start” button) for a user to run a test (shown as a window with “Run Electrode Identifier”).
  • a message or prompt e.g., which may include a “Start” button
  • the test executed upon user input of the prompt of window 810 may include sensing electrical signals from one or more electrode and/or electrode combinations, such as to identify an LFP peak (e.g., an inflection point or relative higher magnitude at one frequency with respect to magnitudes at other surrounding frequencies) for the one or more electrodes or electrode combination or for generating an indication of signal quality as discussed in relation to previous examples.
  • an LFP peak e.g., an inflection point or relative higher magnitude at one frequency with respect to magnitudes at other surrounding frequencies
  • Window 810 may also include an option (e.g., via a toggle button) to run the test for each electrode segment as well as the electrode levels.
  • an option e.g., via a toggle button
  • the option to only ran electrode segments or only electrode levels may reduce the test time, such as when the user is only interested in the results of the electrode segments or the all the electrode levels.
  • a user may want to view information from both the electrode segments and the electrode levels, and the option to run both levels and segments together may reduce the number of user inputs and time needed to otherwise run the test for levels and segments individually.
  • window 810 includes an option (e.g., via selectable icons, data input box, etc.) to run or rerun the test for specific electrode segments and/or specific electrode levels. For example, where a user suspects a test result for a given electrode is not representative (e.g., because of artifact, impedance errors, etc.), or wants to verify previous test results, window 810 may include one or more selectable icons or otherwise receive input to run the test for some (e.g., less than all) electrode segments and/or electrode levels. Testing specific electrode segments and/or levels may be faster than otherwise rerunning all electrode segments and/or levels.
  • an option e.g., via selectable icons, data input box, etc.
  • window 810 may include one or more selectable icons or otherwise receive input to run the test for some (e.g., less than all) electrode segments and/or electrode levels. Testing specific electrode segments and/or levels may be faster than otherwise rerunning all electrode segments and/or levels.
  • FIG. 9 is a conceptual diagram illustrating an example user interface results screen displaying a lead including a representation of a plurality of electrodes and an indication of signal quality based on received signal information for electrodes in accordance with one or more aspects of this disclosure.
  • Screen 900 may be a screen of screen(s) 89.
  • Processing circuitry 80 may cause display 83 to display screen 900 on display 83, For example, when a user selects “Brain Sense Survey” from drop-down menu 502 of FIG. 5 and/or when a user selects the “Start” button to execute the Electrode Identifier test of FIG. 8, processing circuitry 80 may cause display 83 to display screen 900 on display 83.
  • Screen 900 includes a window 910 displaying indication of signal quality 902 tor one or more electrodes.
  • Screen 900 may also include a selected frequency (e.g., 23.82 Hz) which may represent a frequency of sensed electrical signals upon which the indication of signal quality 902 are based.
  • the frequency initially shown e.g., within window 910, shown as 23.82 Hz
  • the system may automatically select the frequency that is shown from tire observed sensed signals.
  • the frequency may be selected by a user and stored by the system.
  • indications of signal quality 902 are displayed on screen 900 within window 910 in a similar manner to those described with respect to screen 600.
  • Screen 900 may display indication of signal quality 902 for one or more electrodes, including a color-based representation and/or graphical representation of a ranking (or level) for each of segmented electrodes la, lb, 1c, 2a, 2b, and 2c.
  • Screen 900 may display each respective indication of signal quality 902 overlaid with the representation of the respective electrode of the plurality of electrodes.
  • indication of signal quality 902 indicates one or more recommended electrodes for
  • SUBSTITUTE SHEET (RULE 26) electrical stimulation therapy (e.g., electrodes that have a higher relative indication of signal quality).
  • screen 900 may also include a frequency (e.g., 23.82 Hz in the example of screen 900) which may represent a frequency corresponding to the sensed electrical signals upon which the indication of signal quality 602 are based.
  • Hie frequency may be a frequency corresponding to peak (e.g., an inflection point or relative high magnitude compared to surrounding magnitudes) of the received signal information (e.g., an LFP peak, as discussed in connection with later examples) when the test (e.g., “BrainSense” survey) is initially executed.
  • screen 900 is configured to receive user input via Frequency Selection Icon 904 to select a different frequency or view' information on the test results.
  • processing circuitry 80 is configured to generate a representation of the plurality of electrodes (e.g., electrodes la, lb, 1c, 2a, 2b, and 2c) and an indication of signal quality (e.g., indication of signal quality 902) based on the received signal information for each electrode of the plurality of electrodes.
  • processing circuitry 80 is configured to generate for display, via a screen (e.g., screen 900), a key indicating the relative ranking for the indications of signal quality 902.
  • a window 914 includes information related to the dots representing the indications of signal quality 902.
  • window' 914 shows that three filled dots for the indications of signal quality corresponds to “Most Power,” two filled dots corresponds to “Medium Power,” and one filled dot corresponds to “Low? Power.”
  • processing circuitry 80 is configured to update, based on user input, the indications of signal quality 902 for one or more electrodes of electrodes la, lb, 1c, 2a, 2b, and 2c.
  • screen 900 includes a “Refresh Survey” Icon 906, which may cause processing circuitry' 80 to redetermine (e.g., at a later time, after the BrainSense Survey test has been executed previously) the indications of signal quality. Since a user (e.g., a clinician) may want to run multiple test because of electrode movement, or to confinn previous results,
  • processing circuitry 80 may update the indications of signal quality 902 in response to user input selecting “Refresh Survey” Icon 906.
  • FIG. 10 is a conceptual diagram illustrating an example user interface results screen displaying a lead including a representation of a plurality of electrodes and an indication of signal quality based on received signal information for electrodes in accordance with one or more aspects of this disclosure.
  • Screen 1000 may be a screen of screen(s) 89.
  • Processing circuitry 80 may cause display 83 to display screen 1000 on display 83.
  • display 83 For example, when a user selects “BrainSense Survey” from drop-down menu 502 of FIG. 5 and/or when a user selects the “Start” button to execute the Electrode Identifier test of FIG. 8, processing circuitry 80 may cause display 83 to display screen 1000 on display 83.
  • Screen 1000 includes a window 1010 displaying indication of signal quality 1002 for one or more electrodes.
  • Screen 1000 may also include a selected frequency (e.g., 6.84 Hz) which may represent a frequency of sensed electrical signals upon which the indication of signal quality 1002 are based.
  • Screen 1000 is similar to screen 900 of FIG. 9, however screen 1000 includes examples of one or more errors related to electrode impedance, which may occur when an impedance of one or more electrodes is greater than a maximum impedance threshold or an impedance of one or more electrodes is less than a minimum impedance threshold.
  • processing circuitry 80 is configured to generate, for display on a screen (e.g., screen 1000), an indication that an indication of signal quality1002 for one or more electrodes (e.g., electrodes 9a, 9b, 9c, 10a, 10b, and 10c as shown in FIG. 10) cannot be generated based on an impedance failure.
  • processing circuitry 80 may be configured to generate for display (e.g., in window 1010 of screen 1000) an “Impedance Failure” message 1008 indicating that an indication of signal quality 1002 for one or more electrodes cannot be generated.
  • the system may determine that the impedance is a failure if the measured impedance is greater than a predetermined threshold, for example.
  • processing circuitry 80 may be configured to cause display 83 to display the representations of particular electrodes that do not meet predefined impedance requirement to include an indication the particular electrodes do not meet the requirement.
  • processing circuitry 80 may be configured to cause display 83
  • FIG. 11 is a conceptual diagram illustrating an example user interface results screen displaying a lead including a representation of a plurality of electrodes and an indication of signal quality based on received signal information for electrodes in accordance with one or more aspects of this disclosure.
  • Screen 1100 may be a screen of screen(s) 89.
  • Processing circuitry' 80 may cause display 83 to display screen 1100 on display 83. For example, when a user selects “BrainSense Survey” from drop-down menu 502 of FIG. 5 and/or when a user selects the “Start” button to execute the Electrode
  • processing circuitry 80 may cause display 83 to display screen 1100 on display 83.
  • display 83 may differ from screen 900 in that the representations of any segmented electrodes may be displayed as virtual ring electrodes which make up a single “level” or axial position along the lead. Indications of signal quality 1102 may be displayed on screen 1 100 in a similar manner to those described with respect to screen 900, however, screen 900 may not display representations of each of the segmented electrodes as any segmented electrodes represented in screen 1100 are acting as virtual ring electrodes.
  • Screen 1100 includes a window 1110 displaying indication of signal quality 1102 for one or more electrodes.
  • Screen 1100 may also include a selected frequency (e.g., 18.73 Hz) which may represent a frequency of sensed electrical signals upon which the indication of signal quality 1102 are based.
  • a selected frequency e.g., 18.73 Hz
  • FIG. 12 is a is a conceptual diagram illustrating an example user interface results screen displaying a lead including a representation of a plurality of electrodes and an indication of signal quality based on received signal information for electrodes in accordance with one or more aspects of this disclosure.
  • Screen 1200 may be a screen of screen(s) 89.
  • Processing circuitry 80 may cause display 83 to display screen 1200 on display 83. For example, when a user selects “BrainSense Survey” from drop-down menu 502 of FIG. 5 and/or when a user selects the “Start” button to execute the Electrode
  • processing circuitry 80 may cause display 83 to display screen 1200 on display 83.
  • processing circuitiy 80 may cause display 83 to display screen 1200 on display 83.
  • Screen 1200 is similar to screen 1100 of FIG. 11, however screen 1200 includes examples of one or more errors related to electrode impedance, which may occur when an impedance of one or more electrodes is greater than a maximum impedance threshold or an impedance of one or more electrodes is less than a minimum impedance threshold.
  • Screen 1200 is also different from screen 1100 in that screen 1200 also includes an indication of artifact (e.g., noise) for one or more electrodes.
  • artifact e.g., noise
  • processing circuitry 80 is configured to generate, for display on a screen (e.g., screen 1200), an indication that an indication of signal quality 1202 for one or more electrodes (e.g., electrodes 9a, 9b, 9c, 10a, 10b, and 10c as shown in FIG. 10) cannot be generated based on an impedance failure.
  • processing circuitry 80 may be configured to generate for display (e.g., in window 1210 of screen 1200) a “Impedance Failure” message 1208 indicating that an indication of signal quality 1202 for one or more electrodes cannot be generated.
  • processing circuitry' 80 is configured to cause display 83 to display one or more indications that an artifact (e.g., an unacceptable level of noise or other undesirable signal feature in the received signal) is associated with one or more electrodes and/or electrode segments (e.g., of electrodes 8, 9, 10, and/or 11).
  • processing circuitiy 80 may be configured to cause display 83 to display an “artifact detected” message 1214, e.g., when the received signal information of one or more electrodes exhibit a level of artifact (e.g., noise or other characteristic) above a predefined artifact threshold and/or otherwise does not meet an artifact requirement.
  • Tire predefined noise threshold and/or the predefined artifact threshold may correspond to a maximum level of noise or artifact to be able to reliably use the indication of signal quality' 1202 for selecting an electrode combination for electrical stimulation therapy.
  • processing circuitry' 80 may be configured to cause display 83 to display the representations of particular electrodes that do not meet the predefined noise or artifact threshold to include an indication that the particular electrodes do not meet the threshold.
  • processing circuitry' 80 may be configured to cause display 83 to display a symbol (e.g., an encircled “i”) overlaying the representation of the particular electrode
  • processing circuitry 80 may be configured to generate for presentation, via the user interface on the first screen (e.g., screen 1700), a message or indications that one or more electrodes do not meet the predefined noise or artifact threshold and/or requirement. In some examples, the system may still allow the user to select an electrode for which an artifact was detected.
  • FIG. 13 is a conceptual diagram illustrating an example user interface results screen displaying a lead including a representation of a plurality of electrodes and an indication of signal quality based on received signal information for electrodes in accordance with one or more aspects of this disclosure.
  • Screen 1300 may be a screen of screen(s) 89.
  • Processing circuitry' 80 may cause display 83 to display screen 1300 on display 83.
  • display 83 For example, when a user selects “BrainSense Survey” from drop-down menu 502 of FIG. 5 and/or when a user selects the “Start” button to execute the Electrode Identifier test of FIG. 8, processing circuitry' 80 may' cause display' 83 to display' screen 1300 on display 83.
  • Screen 1300 is similar to both screen 900 of FIG.
  • screen 1300 includes (e.g., in window 1310 of screen 1300) both representations of segmented electrodes and representations of virtual ring electrodes which make up a single “level” or axial position along the lead.
  • Indications of signal quality 1302 may be displayed on screen 1300 in a similar manner to those described with respect to screen 900 and screen 1100, however, screen 1300 simultaneously displays the indications of signal quality' for both the individual electrode segments as well as the electrode levels.
  • processing circuitry' 80 may be configured to simultaneously display indications of signal quality 1302 for both individual electrode segments (e.g., electrodes la, lb, 1c, 2a, 2 b, and/or 2.C as shown in the example of screen 1300), and electrode levels (e.g., 0, 1, 2, and/or 3 as shown in the example of screen 1300).
  • individual electrode segments e.g., electrodes la, lb, 1c, 2a, 2 b, and/or 2.C as shown in the example of screen 1300
  • electrode levels e.g., 0, 1, 2, and/or 3 as shown in the example of screen 1300.
  • FIG. 14 is a conceptual diagram illustrating an example user interface results screen displaying a lead including a representation of a plurality of electrodes and an indication of signal quality based on received signal information for electrodes in
  • Screen 1400 may be a screen of screen(s) 89. Processing circuitry 80 may cause display 83 to display screen 1400 on display 83. Screen 1400 includes a window 1410 displaying indication of signal quality 1402 for one or more electrodes. Screen 1400 may also include a selected frequency (e.g., 23.82 Hz) which may represent a frequency of sensed electrical signals upon which the indication of signal quality 1402. are based. Screen 1400 is similar to screen 900 of FIG, 9, however indications of signal quality 1402 include bars indicating a relative signal strength for each electrode of electrodes la, lb, 1c, 2a, 2b, and/or 2c (as opposed to filled dots).
  • a selected frequency e.g., 23.82 Hz
  • the bars of indications of signal quality 1402 may resemble WiFi signal strength bars, which may be concentric quarter circle slices, wherein more filled slices indicates a higher signal quality (e.g., a higher LFP magnitude) and less filled slices indicates a lower signal quality (e.g., a lower LFP magnitude).
  • Indications of signal quality 1402 may take other various forms (including representative peak sizes, shapes, colors, and/or combinations thereof).
  • the indications of signal quality may be animated or change over time (e.g., blinking at different rates or increasing and decreasing in color shade or intensity) in order to more easily illustrate which electrodes have higher quality signals than other electrodes.
  • indications of signal quality 1402 may be uniform distribution (e.g., wherein each signal strength bar represents a uniform range of strength) or non-uniform distribution (e.g., wherein each signal strength bar does not represent a uniform range of strength).
  • Indications of signal quality 1402 may indicate one or more received signal information, including LFP magnitude anchor LFP strength, eCAP magnitude, etc., and may be applicable for one or more electrode and/or sensing configurations (e.g., monopolar, bipolar, etc.).
  • FIG. 15 is a is a conceptual diagram illustrating another example user interface results screen displaying a representation of received signal information over a frequency spectrum as well as a representation of a plurality of electrodes and respective indications of signal quality based on the received signal information.
  • Screen 1500 may be a screen of screen) s) 89 and include screen 900 with a child window 1510 overlaid over screen 900.
  • Processing circuitry 80 may cause display 83 to display screen 1500 on display 83. For example, when a user selects Frequency Selection Icon 904 of FIG . 9, processing circuitry 80 may cause display 83 to display screen 1500 on display 83.
  • Screen 1500 may be a screen of screen) s) 89 and include screen 900 with a child window 1510 overlaid over screen 900.
  • Processing circuitry 80 may cause display 83 to display screen 1500 on display 83.
  • Frequency Selection Icon 904 of FIG . 9 processing circuitry 80 may cause display 83 to display screen 1500 on display 83.
  • Screen 1500
  • SUBSTITUTE SHEET includes a chart 1504 representing received signal information (e.g., LFP magnitude) from one or more electrodes over a frequency spectrum (e.g., LFP Frequency, which may be measured in Hz), such as a power spectral density (PSD) chart.
  • Chart 1504 defines an a y-axis of LFP magnitude and an x-axis of frequency.
  • the frequency spectrum of the x- axis may define a suitable range, such as from 0 Hz to 100 Hz, but smaller, larger, or different ranges may be used in other examples.
  • Chart 1504 includes one or more data lines 1506 showing received signal information (e.g., LFP magnitude) over a suitable frequency range (e.g., including Beta and Gamma frequency ranges) for one or more electrodes (e.g., electrodes la, lb, 1c, 2a, 2b, and 2c).
  • Each data line of the one or more data lines 1506 representing received signal information (e.g., LFP magnitude) may represent the received signal information for a single electrode.
  • a processing circuitry 80 may generate, for presentation, via a first screen (e.g., screen 1500) of user interface 86, a representation of the received signal information over a frequency spectrum for the at least one electrode of the plurality’ of electrodes. As shown in the example of FIG.
  • the solid data line 1506 corresponds to the highlighted electrode la in indications of signal quality’ 1502, whereas dotted data lines 1506 correspond to other electrodes of the indications of signal quality 1502. Selecting a different data line or electrode will cause the system to responsively change to the corresponding data line or electrode of the selection.
  • screen 1500 includes a representation of a plurality’ of electrodes lb, 1c, 2a, 2b, and 2c and indications of signal quality 1502.
  • the indications of signal quality 1502 are shown for a particular frequency (e.g., which may be a system-identified peak frequency and/or recommended frequency, shown as 23Hz).
  • a processing circuitry’ 80 may generate, for presentation, via user interface 86, the first screen (e.g., screen 1500) a representation of the plurality of electrodes and 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 on the frequency’ spectrum.
  • the indications of signal quality 1502 indicate one or more electrodes of electrodes lb, 1c, 2a, 2b, and 2c for electrical stimulation therapy.
  • screen 1500 includes a selectable icon 1511 that is moveable to different frequencies over the frequency spectrum shown on screen 1500 within chart 1504.
  • the indications of signal quality 1502 shown on screen 1500 may
  • SUBSTITUTE SHEET correspond to the selected frequency selected by the selectable icon 1511.
  • the first screen e.g., screen 1500
  • the selectable icon moveable within the frequency spectrum to select the at least one frequency for generating the indication of signal quality for the plurality of electrodes.
  • the system may automatically update the indications of signal quality 1502 based on the selected frequency.
  • indications of signal quality 1502 correspond to a particular selected frequency.
  • processing circuitry 80 may automatically determine and/or automatically' update indications of signal quality 1502 for a particular selected frequency, such as when selectable icon 151 1 moves between a first selected frequency and a second selected frequency.
  • processing circuitry 80 is configured to, in response to receiving input moving the selectable icon 1511 within the frequency spectrum, automatically update indication of signal quality 1502 for one of the electrodes of electrodes la, lb, 1c, 2a, 2b, and/or 2c corresponding to a second frequency selected by the input moving the selectable icon 1511 within the frequency spectrum from a first frequency previously selected.
  • One or more selected frequencies may be a system selected frequency (e.g., wherein processing circuitry' 80 automatically selects the frequency, such as based on an algorithm), such as a peak of signal information (e.g., an LFP peak) or a user-selected frequency
  • a peak of signal information e.g., an LFP peak
  • a user-selected frequency e.g., a user-selected frequency
  • the selectable frequencies may be a specific frequency or a frequency band (e.g., specific frequency down to the hundredths of a Hz as shown, or a frequency band that may be less than one Hz or even as large or larger than several Hz.
  • screen 1500 includes a reset icon 1512 that is selectable to reset the frequency to a previous frequency (e.g., the original system-identified peak frequency or another previously identified or selected frequency).
  • a previous frequency e.g., the original system-identified peak frequency or another previously identified or selected frequency
  • the user may wish to return to the original frequency associated with the original system -identified peak frequency (as shown to be 23 Hz) in the example of screen 1500.
  • processing circuitry 80 is configured to, in response to user input, return the selected frequency to an originally identified peak frequency.
  • processing circuitry 80 may be configured to automatically update the indications of
  • SUBSTITUTE SHEET (RULE 26) signal quality based on the previous frequency associated with selection of reset icon 1512.
  • some data lines of one or more data lines 1506 representing received signal information may be highlighted or otherwise indicated as corresponding to a particular electrode.
  • one data line of data lines 1506 is a solid line (not dashed), which may correspond to a particular electrode (e.g., electrode la, as indicated by the encircled representation of electrode la).
  • Other data lines of data lines 1506 may be dashed lines, which may correspond to electrodes that are not encircled (e.g., electrodes lb, 1c, 2a, 2b, and/or 2c).
  • processing circuitry 80 is configured to simultaneously generate the representation of the received signal information over the frequency spectrum (e.g., chart 1504) and indication of signal quality 1502 for two or more electrodes of the plurality of electrodes on the first screen (e.g., screen 1500).
  • screen 1500 includes one or more indications of non- selectable frequencies (e.g., lines 1508) for which one or more indications of signal quality 1502 are not generatable.
  • indications of signal quality 1502 are not generated or are no generatable when the sensed signals do not meet a particular quality or separability threshold in order to be generated.
  • chart 1504 includes lines 1508 (which may also be bars 1508), which may represent single frequencies or bands of frequencies for which the indication of signal quality 1502 cannot be generated by the system.
  • processing circuitry’ 80 is configured to generate, for presentation via the user interface on the first screen (e.g., screen 1500), an indication of one or more non-selectable frequencies (e.g., lines 1508) for which the indication of signal quality is not generatable.
  • Lanes 1508 include dashed lines, bounds, blackouts, ranges, or other indications of non-selectable frequencies.
  • the indication of the one or more non-selectable frequencies (e.g., lines 1508) for which the indication of signal quality is not generatable includes one or more bounds on the one or more frequencies over the frequency spectrum. Lines 1508 may be based on single frequencies or ranges of frequencies that do not meet a minimum separability requirement (discussed in connection with later examples).
  • the system may automatically skip selectable icon 1511 over each of lines 1508 or enable the selectable icon 1511 to remain within line 1508 but prevent any signal quality or frequency selection to be made.
  • FIG. 16 is a is a conceptual diagram illustrating another example user interface results screen displaying a representation of received signal information over a frequency spectrum as well as a representation of a plurality of electrodes and respective indications of signal quality 1602 based on the received signal information.
  • Screen 1600 may be a screen of screen(s) 89 and include screen 900 with a child window 1610 overlaid over screen 900.
  • Processing circuitry' 80 may cause display 83 to display screen 1600 on display 83.
  • processing circuitry may cause display 83 to display screen 1500, which includes one or more messages indicating that the indication of signal quality is not generatable.
  • screen 1600 includes a chart 1604 representing received signal information (e.g., LFP magnitude) from one or more electrodes over a frequency spectrum (e.g., LFP Frequency, which may be measured in Hz).
  • Screen 1600 also includes a selectable icon 1611 that is moveable to different frequencies over the frequency spectrum shown on screen within chart 1604. The indications of signal quality 1602 shown on screen 1600 may correspond to the selected frequency selected by the selectable icon 1611.
  • processing circuitry' 80 is configured to cause display 83 to display one or more indications that indications of signal quality 1602 is not generatable.
  • indications of signal quality 1602 are not generated, and do not include the ratings or rankings indication signal quality' for each electrode, as can be seen in that the representation of each electrode do not include any dots (filled or unfilled).
  • processing circuitry’ 80 may' display an insufficient signal separation message 1612.
  • Insufficient signal separation message 1612 may indicate that the indications of signal quality 1602 are not generated and/or are not generatable, e.g., because the received signal information of different electrodes do not meet the signal separation requirement from delivered stimulation frequency' or some sensed frequency.
  • processing circuitry' 80 in response to selection of a non-selectable frequency (e.g., as indicated by one or more vertical lines 1608 on chart 1604) for which the indication of signal quality 1602 is not generatable, processing circuitry' 80 is configured to generate for presentation, via the user interface on the first screen (e.g., screen 1600), a message indicating indication of signal quality 1602 is not generatable.
  • processing circuitry 80 may be configured to cause display 83 to display one or more indications that one or more electrodes (e.g., of electrodes la, lb, 1c, 2a, 2b, and/or 2c) do not meet a predefined impedance requirement. For example, as shown on screen 1600, processing circuitry' 80 may be configured to cause display 83 to display “Impedance Failure” message 1614 indicating that one or more electrodes do not meet a predefined impedance requirement. Additionally, processing circuitiy' 80 may be configured to cause display 83 to display the representations of particular electrodes that do not meet predefined impedance requirement to include an indication the particular electrodes do not meet the requirement.
  • one or more electrodes e.g., of electrodes la, lb, 1c, 2a, 2b, and/or 2c
  • processing circuitry' 80 may be configured to cause display 83 to display “Impedance Failure” message 1614 indicating that one or more electrodes do not meet a predefined impedance requirement.
  • processing circuitry' 80 may be configured to cause display 83 to display a symbol (e.g., an encircled “X”) overlaying the representation of the particular electrode that does not meet the predefined impedance requirement.
  • processing circuitiy 80 may be configured to generate for presentation, via the user interface on the first screen (e.g., screen 1600), a message or indications that one or more electrodes do not meet the predefined impedance requirement.
  • processing circuitry 80 may be configured to generate a prompt to alter stimulation and/or automatically alter stimulation therapy for the one or more electrodes that do not meet the predefined impedance requirement.
  • altering stimulation may prevent or mitigate impedance errors associated with one or more electrodes, e.g., such that the electrodes meet the predefined impedance requirement.
  • FIG. 17 is a is a conceptual diagram illustrating another example user interface results screen displaying a representation of received signal information over a frequency spectrum as well as a representation of a plurality of electrodes and respective indications of signal quality’ 1702 based on the received signal information.
  • Screen 1700 may be a screen of screen(s) 89 and include screen 900 with a child window 1710 overlaid over screen 900.
  • Processing circuitry 80 may cause display 83 to display screen 1700 on display 83.
  • Screen 1700 is similar to screen 1500 of FIG. 15, however screen 1700 also includes an indication of artifact (e.g., noise) for one or more electrodes (e.g., of electrodes la, lb, 1 c, 2a, 2b, and/or 2c).
  • artifact e.g., noise
  • screen 1700 includes a chart 1704 representing received signal information (e.g., LFP magnitude) from one or more electrodes over a frequency spectrum (e.g., LFP Frequency, which may be measured in Hz).
  • Screen 1700 also includes a selectable icon 1711 that is moveable to different frequencies over the
  • SUBSTITUTE SHEET (RULE 26) frequency spectrum shown on screen within chart 1704. Indications of signal quality 1702 shown on screen 1700 may correspond to the selected frequency selected by tire selectable icon 1711.
  • processing circuitry 80 is configured to cause display 83 to display one or more indications that an artifact (e.g., an unacceptable level of noise in the received signal) is associated with one or more electrodes of electrodes (e.g., of electrodes la, lb, 1c, 2a, 2b, and/or 2c).
  • processing circuitry 80 may be configured to cause display 83 to display an “artifact detected” message 1714, e.g., when the received signal information of one or more electrodes exhibit a level of artifact (e.g., noise) above a predefined noise threshold and/or predefined artifact threshold.
  • the predefined noise threshold and/or the predefined artifact threshold may correspond to a maximum level of noise or artifact to be able to reliably use the indication of signal quality 1702 for selecting an electrode combination for electrical stimulation therapy.
  • processing circuitry 80 may be configured to cause display 83 to display the representations of particular electrodes that do not meet the predefined noise or artifact threshold to include an indication that the particular electrodes do not meet the threshold.
  • processing circuitry 80 may be configured to cause display 83 to display a symbol (e.g., an encircled “i”) overlaying the representation of the particular electrode that does not meet the predefined impedance threshold.
  • processing circuitry 80 may be configured to generate for presentation, via the user interface on the first screen (e.g., screen 1700), a message or indications that one or more electrodes do not meet the predefined noise or artifact threshold.
  • FIG. 18A and FIG. 18B are conceptual diagrams illustrating an example user interface screen displaying signal information over a frequency spectrum (e.g,, a PSD chart).
  • Screen 1800 of FIG. 18A and screen 1801 of FIG. 18B may be screens of screen(s) 89.
  • Processing circuitry 80 may cause display 83 to display screen 1800 and/or screen 1801 on display 83.
  • Screen 1800 includes chart 1804 and screen 1801 includes chart 1805, which may be examples of chart 1504 shown and discussed in connection with FIG. 15, where chart 1804 and chart 1805 represent received signal information (e.g., LFP magnitude) from one or more electrodes over a frequency spectrum (e.g., LFP Frequency, which may be measured in Hz).
  • Chart 1804 includes raw (e.g., unfiltered or unprocessed) received signal information, whereas chart 1805 includes processed (e.g., filtered, transformed, and/or other algorithmically processed) received signal information.
  • one of the raw received signal information or the processed received signal information may be more conducive for visualization of one or more peaks of the received signal information (e.g., LFP peaks), thus processing circuitry 80 may be configured to generate, tor presentation via display 83, both the raw received signal information or the processed received signal information and actually display one or the other based on user input.
  • processing circuitry 80 may be configured to generate, tor presentation via display 83, both the raw received signal information or the processed received signal information and actually display one or the other based on user input.
  • processing circuitry 80 is configured to toggle between chart 1804 displaying raw received signal information and chart 1805 displaying processed received signal information based on user input.
  • screen 1800 and/or screen 1801 includes a toggle button 1818, wherein when activated or pressed, toggle buton 1818 is configured to cause processing circuitry 80 to toggle between chart 1804 and chart 1805 via input to the toggle button 1818.
  • toggle button 1818 includes a slider, which may be slid (e.g., by a user) left and right to select between raw and processed received signal information.
  • FIG. 19A and FIG. 19B are conceptual diagrams illustrating an example user interface screen displaying representations of electrodes, which may include indications of signal quality for each respective electrode.
  • Screen 1900 of FIG, 19A and screen 1901 FIG. 19B both display a representation of the plurality of electrodes (e.g., as shown as electrodes la, lb, 1c, 2a, 2b, and 2c), however only screen 1901 includes indications of signal quality 1902 overlaid on the representations of electrodes.
  • Both of screen 1900 and screen 1901 indicate “Insufficient Signal Separation,” however screen 1900 does not display the indications of signal quality, such as discussed in connection with FIG. 16 (e.g., because a signal separation requirement does not meet a predefined threshold).
  • Screen 1901 includes indications of signal separation 1902, including filled dots some of electrodes of electrodes la, lb, 1c, 2a, 2b, and 2c.
  • processing circuitry 80 is be configured to toggle between screen 1900 and screen 1901 based on user input, e.g., to display indications of signal quality' 1902 even though the signal separation requirement does not meet the predefined threshold). For example, a user (e.g., a clinician) may desire to view indications of signal quality 1902 even where a signal separation requirement does not meet the predefined threshold.
  • screen 1900 and/or screen 1901 includes a toggle button 1919, wherein when activate, toggle button 1919 is configured to cause processing circuitry 80 to toggle between screen 1900 and screen 1901.
  • toggle button 1919 is configured to cause processing circuitry 80 to toggle between screen 1900 and screen 1901.
  • SUBSTITUTE SHEET (RULE 26) buton 1919 includes a slider, which may be slid (e.g., by a user) left and right to select displaying indications of signal quality 1902 or not displaying indications of signal quality 1902.
  • Processing circuitry 80 then generates, for presentation on a first screen (e.g., screen 1500) of screen(s) 89 of a user interface 86, a representation of the received signal information over a frequency spectrum (chart 1504) for the at least one electrode of electrodes 24 and/or electrodes 26 (2002).
  • the signal information may include amplitudes for different frequencies for each of the electrodes that are selectable or for which the signal information was received.
  • screen 1500 includes a selectable icon 151 1 moveable within the frequency spectrum to select the at least one frequency for generating the indication of signal quality 1502 for the plurality of electrodes.
  • processing circuitry 80 may generate, for presentation via user interface 86 on the first, screen (e.g., screen 1500), an indication of one or more non- selectable frequencies for which the indication of signal quality is not generatable (e.g., lines 1508).
  • Processing circuitry' 80 also generates, for presentation on tire first screen (e.g., screen 1500) of screen(s) 89 of user interface 86, a representation of electrodes 24 and/or electrodes 26 (e.g., shown as electrodes la, lb, 1c, 2a, 2b, and 2c in the example of screen 1500) and an indication of signal quality 1502 based on the received signal information for each electrode of electrodes 24 and/or electrodes 26, wherein the indication of signal quality 1502 corresponds to at least one frequency on the frequency spectrum (2004).
  • processing circuitry 80 may generate the representations of electrodes
  • SUBSTITUTE SHEET (RULE 26) and the indications of signal quality 1502 for two or more electrodes of electrodes 24 and/or electrodes 26.
  • processing circuitry' 80 in response to receiving input moving selectable icon 151 1 within the frequency spectrum (decision block 2006), automatically updates indication of signal quality 1502 for the at least one electrode of electrodes 24 and/or electrodes 26 (2008).
  • the updated indication of signal quality may correspond to a second frequency selected by the input moving the selectable icon 151 1 within the frequency spectrum from a first frequency previously selected.
  • processing circuitry 80 may update the indications of signal quality' presented via the screen (e.g., screen 1500) based on a change in signal quality corresponding to the different frequencies (e.g., update from two dots associated with the first frequency to three dots associated with the second frequency).
  • the indication of signal quality 1502 remains unchanged (e.g., may' remain as three dots at both the first frequency' and the second frequency), based on the signal quality being the same or similar at the respective frequencies.
  • a user e.g., a clinician
  • processing circuitry 80 generates, for presentation via user interface 86 on the first screen (e.g., screen 1500), an indication of one or more non- selectable frequencies for which the indication of signal quality is not generatable (e.g., lines 1508).
  • processing circuitry 80 may' automatically skip selectable icon 1511 over each of lines 1508 or enable the selectable icon 1511 to remain w'ithin line 1508 but prevent any signal quality or frequency selection to be made.
  • processing circuitry 80 in response to receiving input selecting reset icon 1512 of screen 1500, processing circuitry’ 80 is configured to reset the frequency to a previous frequency. For example, after a user moves selectable icon 151 1 a new frequency (e.g., such as to view the updated indications of signal quality 1502), processing circuitry 80 may be configured to move icon 1511 back to the original sy stem-identified peak frequency in response to receiving input selecting reset icon 1512. In this manner, processing circuitry 80 is configured to, in response to user input, return the selected
  • processing circuitry 80 may be configured to automatically update the indications of signal quality based on the previous frequency associated with selection of reset icon 1512.
  • a clinician programs therapy (e.g., selects or more electrodes for sensing and/or stimulation therapy) based on the representations of signal quality 1502.
  • the indications of signal quality 1502 may indicate or recommend one or more electrodes or electrode combinations for programming therapy.
  • processing circuitry 80 generates for presentation on the first screen (e.g., screen 1500) of screen(s) 89 of user interface 86, the indication or recommendation of electrodes for therapy.
  • a clinician may be able to override the system generated recommendation for electrodes and program therapy in other ways (e.g., choose a different electrode combination than the recommended electrode combination for sensing and/or stimulation therapy).
  • processing circuitry 80 programs, via telemetry circuitry 84, 1MD 16 to provide electrical stimulation therapy according to a stimulation therapy program (e.g., therapy program 74), the stimulation therapy program defining an electrode combination for deep brain stimulation (DBS) therapy based on the indication of signal quality 1502 for each electrode of electrodes 24 and/or electrodes 26.
  • processing circuitry 80 adjusts the stimulation therapy program (e.g., therapy program 74) based on the one or more signals sensed via the at least one electrode of electrodes 24 and/or electrodes 26.
  • the techniques described in this disclosure may be implemented, at least in part, in hardware, software, firmware or any combination thereof.
  • 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.
  • 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
  • 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.
  • 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.
  • IMD an intracranial pressure
  • external programmer a combination of an IMD and external programmer
  • IC integrated circuit
  • set of ICs a set of ICs
  • discrete electrical circuitry residing in an IMD and/or external programmer.
  • Example I A medical device system comprising: a memory configured to store instructions defining a user interface; telemetry circuitry; and processing circuitry coupled to the memory and the telemetry circuitry', the processing circuitry being configured to: receive, via the telemetry 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); generate, for presentation via a first screen of the user interface, a representation of the received signal information over a frequency spectrum for the at least one electrode of the plurality of electrodes; and generate, for presentation via the first screen of the user interface, a representation of the plurality of electrodes and 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 on the frequency spectrum.
  • IMD implantable medical device
  • Example 2 The medical device system of example 1, wherein the first screen includes a selectable icon moveable within the frequency spectrum to select the at least one frequency for generating the indication of signal quality for the plurality of electrodes.
  • Example 3 The medical device system of example 2, wherein in response to receiving input moving the selectable icon within the frequency spectrum, the processing circuitry' is configured to automatically update the indication of signal quality for the at least one electrode of the plurality of electrodes corresponding to a second frequency selected by the input moving the selectable icon within the frequency spectrum from a first frequency previously selected.
  • Example 4 Tire medical device system of any of examples 1 through 3, wherein the processing circuitry is configured to generate, for presentation via the user interface on the first screen, an indication of one or more non-selectable frequencies for which the indication of signal quality is not generatable.
  • Example 5 The medical device system of example 4, wherein the indication of tire one or more non-selectable frequencies for which the indication of signal quality is not generatable includes one or more bounds on the one or more non-selectable frequencies over the frequency spectrum.
  • Example 6 The medical device system of example 5, wherein in response to selection of a non-selectable frequency for which the indication of signal q uality is not generatable, the processing circuitry is configured to generate for presentation, via the user interface on the first screen, a message indicating the indication of signal quality is not generatable.
  • Example 7 The medical device system of any of examples 1 through 6, wherein the processing circuitry is configured to simultaneously generate the representation of the received signal information over the frequency spectrum and the indication of signal quality for two or more electrodes of the plurality of electrodes on the first screen.
  • Example 8 The medical device system of any of examples 1 through 7, wherein the plurality of electrodes comprises at least one segmented electrode that is disposed at a partial perimeter around a lead.
  • Example 9 The medical device system of any of examples 1 through 8, wherein the signal information comprises information representative of electrical signals including local field potentials (LFPs).
  • LFPs local field potentials
  • Example 10 The medical device system of any of examples 1 through 9, wherein the indication of signal quality is based on a spectral power of the at least one frequency of local field potentials (LFPs).
  • LFPs local field potentials
  • Example 18 The medical device system of any of examples 1 through 17, wherein the processing circuitry is configured to automatically’ select the at least one frequency on the frequency spectrum .
  • Example 20 The method of example 19, wherein the first screen includes a selectable icon moveable within the frequency’ spectrum to select the at least one frequency tor generating the indication of signal quality for the plurality of electrodes.
  • Example 21 The method of example 20, further comprising: in response to receiving input moving the selectable icon within the frequency spectrum, automatically updating, by the processing circuitry-’, the indication of signal quality for the at least one electrode of the plurality of electrodes corresponding to a second frequency selected by the input moving the selectable icon within the frequency spectrum from a first frequency previously selected.
  • Example 24 The method of any of examples 19 through 23, programming, by the processing circuitry and 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 indication of signal quality for each electrode of the plurality of electrodes, and adjust, by the processing circuitry, the stimulation therapy program based on tire one or more signals sensed via the at least one electrode of the plurality of electrodes.
  • DBS deep brain stimulation

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Psychology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Physiology (AREA)
  • Human Computer Interaction (AREA)
  • Electrotherapy Devices (AREA)

Abstract

La présente invention concerne un système donné à titre d'exemple qui comprend une mémoire configurée pour stocker des instructions définissant une interface utilisateur, un circuit de télémesure et un circuit de traitement couplé à la mémoire et au circuit de télémesure. Le circuit de traitement est configuré pour recevoir des informations de signal représentant des signaux détectés par l'intermédiaire d'au moins une électrode d'une pluralité d'électrodes d'un dispositif médical implantable (DMI). Le circuit de traitement est configuré pour générer, pour une présentation par l'intermédiaire d'un premier écran de l'interface utilisateur, une répresentation des informations de signal reçues sur un spectre de fréquence pour la ou les électrodes de la pluralité d'électrodes. Le circuit de traitement est configuré pour générer, pour une présentation par l'intermédiaire du premier écran, une représentation de la pluralité d'électrodes et une indication de qualité de signal sur la base des informations de signal reçues pour chaque électrode de la pluralité d'électrodes, l'indication de qualité du signal correspondant à au moins une fréquence sur le spectre de fréquence.
PCT/US2024/039603 2023-07-28 2024-07-25 Interface utilisateur avec résultats de détection d'électrode Pending WO2025029593A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202363516455P 2023-07-28 2023-07-28
US63/516,455 2023-07-28
US202463623001P 2024-01-19 2024-01-19
US63/623,001 2024-01-19

Publications (1)

Publication Number Publication Date
WO2025029593A1 true WO2025029593A1 (fr) 2025-02-06

Family

ID=92302653

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/039603 Pending WO2025029593A1 (fr) 2023-07-28 2024-07-25 Interface utilisateur avec résultats de détection d'électrode

Country Status (1)

Country Link
WO (1) WO2025029593A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110264165A1 (en) * 2010-04-27 2011-10-27 Medtronic, Inc. Stimulation electrode selection
US20160045746A1 (en) * 2014-08-15 2016-02-18 Axonics Modulation Technologies, Inc. Integrated Electromyographic Clinician Programmer for Use with an Implantable Neurostimulator
US20220387802A1 (en) * 2021-06-03 2022-12-08 Medtronic, Inc. Monopolar recording in a fully implantable medical sensing device for programming guidance

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110264165A1 (en) * 2010-04-27 2011-10-27 Medtronic, Inc. Stimulation electrode selection
US20160045746A1 (en) * 2014-08-15 2016-02-18 Axonics Modulation Technologies, Inc. Integrated Electromyographic Clinician Programmer for Use with an Implantable Neurostimulator
US20220387802A1 (en) * 2021-06-03 2022-12-08 Medtronic, Inc. Monopolar recording in a fully implantable medical sensing device for programming guidance

Similar Documents

Publication Publication Date Title
US10449369B2 (en) Brain stimulation programming
CN112999518B (zh) 针对电刺激治疗的电极选择
US10252055B2 (en) Target therapy delivery site selection
US12427316B2 (en) Directional sensing for programming guidance
AU2011245696A1 (en) Brain stimulation programming
US8447406B2 (en) Medical method and device for monitoring a neural brain network
EP4049717B1 (fr) Caractérisation d'électrode pour le guidage de programmation
US20220387802A1 (en) Monopolar recording in a fully implantable medical sensing device for programming guidance
CN114828944A (zh) 用于控制亚感知刺激的外部控制器
WO2025029593A1 (fr) Interface utilisateur avec résultats de détection d'électrode
US20220230742A1 (en) Medical device management
WO2025029591A1 (fr) Résultats de détection d'électrodes intégrés à une attribution d'électrodes
EP3568197B1 (fr) Administration précise de stimulation électrique
WO2022256844A1 (fr) Enregistrement monopolaire dans un dispositif de détection médical entièrement implantable pour un guidage de programmation
US20240033527A1 (en) Parameter indication for electrical stimulation
WO2024025913A1 (fr) Conversion entre une thérapie de stimulation électrique bipolaire et unipolaire

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 24755159

Country of ref document: EP

Kind code of ref document: A1