WO2025029591A1 - Electrode sensing results integrated with electrode assignment - Google Patents
Electrode sensing results integrated with electrode assignment Download PDFInfo
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- WO2025029591A1 WO2025029591A1 PCT/US2024/039597 US2024039597W WO2025029591A1 WO 2025029591 A1 WO2025029591 A1 WO 2025029591A1 US 2024039597 W US2024039597 W US 2024039597W WO 2025029591 A1 WO2025029591 A1 WO 2025029591A1
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- 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
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- 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
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- 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
- 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.
- DBS deep brain stimulation
- SCS spinal cord stimulation
- 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 with the aid of two or more 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.
- a clinician may generate one or more therapy programs (also referred to as therapy parameter sets) that are found to provide efficacious therapy to the patient, where each therapy program may define values for a set of therapy parameters.
- therapy programs also referred to as therapy parameter sets
- a medical device may deliver therapy to a patient according to one or more stored therapy programs.
- the therapy parameters may define characteristics of the electrical stimulation waveform to be delivered.
- the Docket No.: A0010290WO01/1123-801WO01 therapy parameters may include an electrode configuration including a stimulating electrode combination and electrode polarities, an amplitude, that may be a current or voltage amplitude, a pulse width, and a pulse rate.
- this disclosure is directed to devices, systems, and methods for presenting and receiving information relating to programming of therapy parameters, such as stimulating electrode(s) and/or electrode segment(s) (which may be considered electrodes, for the purposes of this disclosure), within a system that may utilize sensed signals, such as LFPs (local field potentials), evoked compound action potential (eCAP), or other evoked response, to identify electrodes on one or more implantable leads that may be most appropriate for delivery of stimulation.
- sensed signals such as LFPs (local field potentials), evoked compound action potential (eCAP), or other evoked response
- a system is configured to receive sensed signals and identify, based on the signals, electrodes on one or more implantable leads that may be most appropriate for delivery of stimulation.
- the system may sense signals between each electrode on a lead using a particular electrode as a reference (e.g., a reference electrode). Such sensing may be referred to as monopolar sensing when the spacing between sensing electrodes is significantly greater than the spatial extent of the signal source.
- monopolar sensing may include sensing when the spacing between sensing electrodes is in the range of 30 – 40 mm or greater than the spatial extent of the signal source, which may be in the range of 3 – 9 mm.
- the reference electrode is an electrode on a different lead than the lead including the sense electrode(s).
- the reference electrode may be a distal most or proximal most electrode on the same lead as the sensing electrodes.
- the system may perform the sensing of signals in this manner on each lead of the system. In this manner, the system may sense signals between different electrodes in order to highlight relevant differences between stimulation delivered via each of the electrodes.
- the system may determine indications of signal quality based on received signal information, which may include levels of recommendation or recommendation ratings, for electrodes based on the sensed signals and present the indications of signal quality on a programming screen where the clinician may select which electrodes are to be used as Docket No.: A0010290WO01/1123-801WO01 stimulation electrodes.
- the indications of signal quality may be integrated into a same screen from which a user may select the electrodes to be used as stimulation electrodes.
- a medical device system includes: a memory configured to store a user interface; telemetry circuitry; and processing circuitry coupled to the memory and the telemetry circuitry, the processing circuitry being configured to: generate, for presentation via the user interface, a first screen presenting a representation of a plurality of electrodes and an indication of signal quality based on received signal information for at least one of the plurality of electrodes; obtain, via the first screen of the user interface, a selection of one or more of the at least one of the plurality of electrodes as stimulating electrodes; and program, via the telemetry circuitry, an implantable medical device (IMD) to provide electrical stimulation according to a stimulation program, the stimulation program defining the stimulation electrodes.
- IMD implantable medical device
- a method includes generating, for presentation via a user interface, a first screen presenting a representation of a plurality of electrodes and an indication of signal quality based on received signal information for at least one of the plurality of electrodes; obtaining, via the first screen of the user interface, a selection of one or more of the at least one of the plurality of electrodes as stimulating electrodes; and programing, via the telemetry circuitry, an implantable medical device (IMD) to provide electrical stimulation according to a stimulation program, the stimulation program defining the stimulation electrodes.
- IMD implantable medical device
- a non-transitory computer-readable storage medium stores instructions that, when executed, cause processing circuitry to: generate, for presentation via a user interface, a first screen presenting a representation of a plurality of electrodes and an indication of signal quality based on received signal information for at least one of the plurality of electrodes; obtain, via the first screen of the user interface, a selection of one or more of the at least one of the plurality of electrodes as stimulating electrodes; and program, via the telemetry circuitry, an implantable medical device (IMD) to provide electrical Docket No.: A0010290WO01/1123-801WO01 stimulation according to a stimulation program, the stimulation program defining the stimulation electrodes.
- 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.
- 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 plurality of electrodes in accordance with one or more aspects of this disclosure.
- 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.
- FIG.6 is a conceptual diagram illustrating an example user interface results screen displaying a lead including plurality of electrodes and respective levels of recommendations or recommendation ratings for some of the electrodes in accordance with one or more aspects of this disclosure.
- FIG.7 is a conceptual diagram illustrating another example user interface results screen displaying a lead including plurality of electrodes and respective levels of recommendations or recommendation ratings for some of the electrodes in accordance with one or more aspects of this disclosure.
- FIG.8 is a conceptual diagram illustrating the example user interface results screen of FIG.6 include an indication of user inputs in accordance with one or more aspects of this disclosure. Docket No.: A0010290WO01/1123-801WO01 [0020]
- FIG.9 is a conceptual diagram illustrating the example user interface results screen of FIGS.6 and 8 including a selection of stimulation electrodes via user input in accordance with one or more aspects of this disclosure.
- Screen 900 may be a screen of screen(s) 89.
- FIG.10 is a conceptual diagram illustrating an example user interface lead screen displaying a lead including selected electrodes as stimulation electrodes and providing an input for other parameters associated with a therapy program in accordance with one or more aspects of this disclosure.
- FIG.11 is a conceptual diagram illustrating an example screen including power spectral densities in accordance with one or more techniques of this disclosure.
- FIG.12 is a flow diagram of an example technique for selecting an electrode combination to deliver electrical stimulation, in accordance with one or more techniques of this disclosure.
- a clinician may test each possible combination of electrodes which may be used as stimulation electrodes for the stimulation program. For example, a clinician may use sensed signals to determine which combination of electrodes is to be used as stimulation electrodes. As the number of electrodes being used with IMDs has grown and the use of segmented electrodes has become more widespread, this programming has become more difficult with a dramatic increase in the number of possible combinations of electrodes to be used as stimulation electrodes. Analyzing and retaining the sensed signals is not possible in the mind of a human being, particularly for systems using a large number of electrodes and/or segmented electrodes.
- this disclosure is directed to providing a user interface that may facilitate a clinician viewing suggested or recommended electrodes for use as stimulation electrodes on a same screen as for programming electrodes as stimulation electrodes.
- Providing information regarding which electrodes are suggested to be used as stimulation electrodes on a same screen where a clinician may program electrodes as stimulation electrodes may simplify the programming process. For example, by providing detailed test Docket No.: A0010290WO01/1123-801WO01 results which a clinician may analyze for each of a large number of electrodes and requiring a clinician to navigate to other screens to select the desired electrodes for use as stimulation electrodes may be complicated.
- a human may not be capable of retaining all of the information provided on the various test result screens in their mind as they navigate to one or more other screens from which to select electrodes as stimulation electrodes for a given therapy program.
- LFPs to identify electrodes on one or more implantable leads that may be most appropriate for delivery of stimulation is discussed in U.S. Patent Publication 2022-0387802 A1, which is hereby incorporated by reference in its entirety. The techniques of this disclosure may be particularly useful with such a system.
- the indications of signal quality, such as a recommendation of electrodes for use as stimulation electrodes, generated by the system stimulation electrodes may be based on the utilization of sensed electrical signals, such as LFPs within the brain, to identify which electrodes of a plurality of electrodes, for example, of an implanted lead, may be appropriate to deliver electrical stimulation for a given therapy program.
- the system may generate an indication of signal quality for some or all of the electrodes.
- the recommendation for these electrodes may be based on this signal quality associated with the electrode.
- the signal quality may be representative of characteristics of the sensed signal from the electrode, such as signal amplitude (e.g., total amplitude or amplitude from one or more frequency bands), noise present in the signal, etc.
- Parkinson’s Disease is a progressive neuro-degenerative disorder characterized by the depletion of dopaminergic neurons in the basal ganglia-thalamo-cortical network. As PD progresses, the manifestations of the disease may include one or more of the characteristic motor dysfunctions that include one or more of akinesia, bradykinesia, rigidity, and tremor.
- 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 in the basal ganglia. Docket No.: A0010290WO01/1123-801WO01 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 for determining appropriate electrode combinations and/or other stimulation parameters may subject the patient to undesirable side effects during this lengthy process and/or may result in less than optimal stimulation parameters, thus lessening the therapeutic value of any therapy delivered.
- the target region associated with a disease e.g., PD
- signals of interest e.g., Beta waves that may be indicative of symptoms such as tremor in PD.
- a system may sense 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 signal quality which may include a recommendation), such as information that may be presented to a clinician and/or information used by the system to select parameter values for stimulation such which of the electrodes should serve as two or more stimulation electrodes.
- the sensed signals may be between electrodes at different circumferential positions and/or electrodes at different axial positions on one lead and a reference electrode on another lead (e.g., monopolar sensing).
- the clinician, or the system may then determine parameters for stimulation based on one or more characteristics of these obtained signals instead of having to test stimulation provided by each electrode combination.
- parameters for stimulation may include which electrodes are to be used for stimulation, a polarity of the electrodes used for stimulation (e.g., anode or cathode), and parameters of the electrical stimulation signal, such as voltage or current amplitude, frequency, waveform shape, on/off cycling state (e.g., if cycling is “off,” stimulation is always on, and if cycling is “on,” stimulation is cycled on and off) and, in the case of electrical stimulation pulses, current or voltage pulse amplitude, pulse rate, pulse width, and other appropriate parameters such as duration or duty cycle.
- Such parameters may be applicable to a given therapy program.
- 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 Docket No.: A0010290WO01/1123-801WO01 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. The system may then identify the electrode combinations, and thus axial (or level) and 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.
- the system may present summary information relating to signal quality, such as levels of recommendation or recommendation ratings, to a clinician for different electrodes to enable the clinician to easily select which electrodes the clinician desires to use as stimulation electrodes.
- the signal quality and/or recommendation ratings may be based on sensed LFPs (and/or characteristics such as spectral power) from different electrode combinations. The sensed LFPs may also be available for viewing by the clinician should the clinician desire to do so.
- the signal quality and/or recommendation ratings may be based on other sensed signals, such as eCAPs or other evoked responses.
- the system may provide the summary information based on the sensed LFPs, such as via a colored representation, a graphical representation (such as a number of dots, a sliding scale, or the like), or other representation which may distinguish between more highly recommended and less highly recommended electrodes for use as stimulation electrodes.
- Such summary information may be presented on a same screen upon which a clinician may select or program an electrode as a stimulating electrode.
- 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 (e.g., recommendation ratings) 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 Docket No.: A0010290WO01/1123-801WO01 of the lead, at a given axial position, each lead may have electrodes at different circumferential positions (e.g., at different positions around the perimeter of the lead). Hence, two or more segmented electrodes may be positioned at the same axial position along the length of the lead (e.g., on the same level of the lead).
- 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 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, gamma waves, theta waves, 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, gamma waves, theta waves, and high frequency oscillations (HFO)
- the system or a clinician may use this information to determine which electrodes (and/or other stimulation parameter values) should be used to deliver electrical stimulation therapy.
- the system may provide information representative of the sensed electrical signals via a display to enable a clinician to program stimulation more effectively and in less time than using trial-and-error approaches.
- a clinician may select which electrodes to use for stimulation. For example, a clinician may utilize the Docket No.: A0010290WO01/1123-801WO01 medical device to record sensed electrical signals between different pairs of electrodes on a single lead (e.g., bipolar sensing) and a display to display representations of the recorded bipolar sensed electrical signals.
- a clinician may utilize the Docket No.: A0010290WO01/1123-801WO01 medical device to record sensed electrical signals between different pairs of electrodes on a single lead (e.g., bipolar sensing) and a display 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 each electrode on the symptoms of a patient. However, this process may take as several hours and be uncomfortable for the patient. [0035] Moreover, even with systems that may provide monopolar sensing results to a clinician when determining one or more therapy programs, such results may not be provided in such a manner that a clinician may easily select appropriate electrodes as stimulation electrodes based on the results. [0036] According to the techniques of this disclosure, a medical device may generate, for presentation via a user interface, a first screen presenting an indication of signal quality based on received signal information for at least one of the plurality of electrodes.
- the medical device may obtain, via the first screen of the user interface, a selection of one or more of the at least one of the plurality of electrodes as stimulation electrodes.
- the medical device may program, via the telemetry circuitry, an implantable medical device (IMD) to provide electrical stimulation according to a stimulation program, the stimulation program defining the stimulation electrodes.
- IMD implantable medical device
- the techniques of this disclosure may streamline selection of stimulation electrodes and/or reduce a likelihood that a clinician may misremember, mistranscribe, or otherwise make an error which may result in the incorrect programming of a therapy program for an IMD.
- FIG.1 is a conceptual diagram illustrating an example therapy system 10 that is configured to deliver therapy to patient 12 to manage a disorder of patient 12.
- Patient 12 ordinarily will be a human patient. In some cases, however, therapy system 10 may be applied to other mammalian or non-mammalian non-human patients.
- 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, 26.
- IMD 16 includes a stimulation generator (not shown in FIG.1) configured to generate and deliver electrical stimulation therapy to the STN region of brain 28 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 deep brain stimulation
- 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
- 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 e.g., mood disorders, memory disorders, mentation disorders, movement disorders
- IMD 16 may be implanted within other regions of patient 12, such as a subcutaneous pocket in the abdomen or buttocks of patient 12 or proximate the cranium of patient 12.
- Implanted lead extension 18 is coupled to circuitry in IMD 16 via proximal electrical contacts that connect to electrical terminals in connector block 30 (also referred to as a header).
- Lead extension 18 may include, for example, distal electrical contacts that electrically couple to proximal electrical contacts of leads 20A, 20B, which in turn may be coupled to respective electrodes 24, 26 via conductors within leads 20A, 20B.
- proximal electrical contacts of leads 20A, 20B and the distal electrical contacts of lead extension 18 electrically couple the electrodes 24, 26 carried by leads 20 to the proximal contacts of lead extension 18 via conductors within the lead Docket No.: A0010290WO01/1123-801WO01 extension 18, and in turn to circuitry of IMD 16 via terminals in connector block 30.
- Lead extension 18 traverses from the implant site of IMD 16 within a chest cavity of patient 12, along the neck of patient 12 and through the cranium of patient 12 to access brain 28.
- IMD 16 may be constructed of a biocompatible material that resists corrosion and degradation from bodily fluids.
- IMD 16 may comprise a hermetically sealed housing 34 to substantially enclose components, such as a processor, therapy circuitry, and memory.
- 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 may be positioned to deliver electrical stimulation to one or more target tissue sites within brain 28 to manage patient symptoms associated with a disorder of patient 12.
- Leads 20 may be implanted to position electrodes 24, 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, 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. [0044] In the examples shown in FIG.1, electrodes 24A, 24D, 26A, and 26D of leads 20 are shown as ring electrodes. Ring electrodes may be relatively easy to program and may be Docket No.: A0010290WO01/1123-801WO01 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.
- 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, in other examples, by multiple electrodes located at different positions around the perimeter of the lead.
- electrodes 24B, 24C, 26B, and 26C may be include multiple electrodes (e.g., partial ring electrodes or segmented electrodes), any of these electrodes may be replaced by ring electrodes.
- 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
- the set of electrodes 26 of lead 20B 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.
- electrode combinations for stimulation and/or sensing may be formed by combinations of one Docket No.: A0010290WO01/1123-801WO01 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.
- leads 20 may have shapes other than elongated cylinders as shown in FIG.1 with active or passive tip configurations.
- leads 20 may be paddle leads, spherical leads, bendable leads, or any other type of shape effective in treating patient 12.
- 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, 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, 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 system 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, 26, another set of electrodes, or both.
- electrodes 24, 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 Docket No.: A0010290WO01/1123-801WO01 brain signals.
- the sensing circuitry of IMD 16 may sense bioelectrical brain signals via one or more of the electrodes 24, 26 that are also used to deliver electrical stimulation to brain 28.
- one or more of electrodes 24, 26 may be used to sense bioelectrical brain signals while one or more different electrodes 24, 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 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 allowed 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.
- the buttons may be dedicated to performing a certain function, e.g., a power button, the buttons and the keypad may be soft keys that change in function depending upon the section of the user interface currently viewed by the user, or any combination thereof.
- 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 Docket No.: A0010290WO01/1123-801WO01 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, 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, 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, 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/identification of therapy programs by providing a system for identifying potentially beneficial therapy parameter values. For example, during a programming session, the physician may select an electrode combination for delivery of therapy to the patient.
- the physician may have the option to create several therapy programs. Some programs may have the same electrode combination to be used as stimulation electrodes (but different values of at least one other therapy parameter) and these therapy programs may be organized into subsets, each subset having the same electrode combination.
- the physician may select an efficacious therapy program for each subset based on a displayed list of sensed LFP signals from electrode combinations.
- the clinician may select a therapy program based on a list displayed on external programmer 14 of combinations of electrodes providing the largest LFP spectral power to provide therapy to patient 12 to address symptoms associated with the patient condition.
- Programmer 14 may also be configured for use by patient 12.
- programmer 14 When configured as a patient programmer, programmer 14 may have limited functionality (compared to a clinician programmer) in order to prevent patient 12 from altering critical functions of IMD 16 or applications that may be detrimental to patient 12. [0055] Whether programmer 14 is configured for clinician or patient use, programmer 14 is configured to communicate with IMD 16 and, optionally, another computing device, via Docket No.: A0010290WO01/1123-801WO01 wireless communication. Programmer 14, for example, 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 802.11 or Bluetooth specification sets, infrared (IR) communication according to the IRDA specification set, or other standard or proprietary telemetry protocols. Programmer 14 may also communicate with other programming or computing devices via exchange of removable media, such as magnetic or optical disks, memory cards, or memory sticks. Further, programmer 14 may communicate with IMD 16 and another programmer via remote telemetry techniques known in the art, communicating via a personal area network (PAN), a local area network (LAN), wide area network (WAN), public switched telephone network (PSTN), or cellular telephone network, for example.
- 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. The external medical device may be coupled to percutaneous leads or to implanted leads via a percutaneous extension. If the trial stimulator indicates therapy system 10 provides effective treatment to patient 12, the clinician may implant a chronic stimulator within patient 12 for relatively long-term treatment. In another example, a clinician in an operating room may obtain acute recordings during lead placement and before coupling the lead with an IMD.
- a 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.
- a clinician in an operating room may 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 Docket No.: A0010290WO01/1123-801WO01 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.
- a clinician may program IMD 16 with a therapy program (or a plurality of therapy programs) that defines stimulation parameter values that balance effective therapy and minimize side effects. For example, a clinician may select electrodes to deliver stimulation that did not sense the 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. [0058] With the aid of programmer 14 or another computing device, a clinician may select values for therapy parameters for therapy system 10, including an electrode combination to be used as stimulation electrodes.
- 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.
- values for the other stimulation parameter values that define the electrical stimulation signal e.g., the amplitude, pulse width, and pulse rate
- the clinician may generate an efficacious therapy for patient 12 that is delivered via the selected electrode subset. Due to physiological diversity, condition differences, and inaccuracies in lead placement, the parameter values may vary between patients.
- the clinician may determine one or more therapy programs that may provide effective therapy to patient 12.
- Patient 12 may provide feedback to the clinician as to the efficacy of the specific program being evaluated, that may include information regarding adverse effects of delivery of therapy according to the specific program.
- the patient feedback may be used to determine a clinical rating scale score.
- 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.
- the time necessary for a review by a clinician grows. Further, the exploration and programming time required for directional stimulation across multiple combinations of electrodes increases as well.
- a representation of a level of recommendation or recommendation rating based on sensed electrical signals sensed by multiple combinations of electrodes may be displayed to the clinician. The clinician may then select, or the system may automatically select, electrodes to provide electrical stimulation based on the sensed signals (e.g., the electrodes that sensed the greatest signal strength).
- IMD 16 includes sensing circuitry configured to sense electrical signals from a first plurality of electrode combinations, each of the first plurality of electrode combinations comprising a same reference electrode of a first lead and at least one, different sense electrode of a second lead. In some examples, one or more of the reference or sense electrodes may reside on a housing or “can” of IMD 16, rather than on a lead. In some examples, IMD 16 includes processing circuitry configured to record the sensed electrical signals from the first plurality of electrode combinations, provide representations of the recorded sensed electrical signals, receive an indication, from a clinician, of two or more Docket No.: A0010290WO01/1123-801WO01 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.
- 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 therapy 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.
- a level of recommendation e.g., a recommendation rating
- levels of recommendation may be based on the sensed electrical signals.
- 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 may generate, for presentation via a user interface, a first screen presenting an indication of signal quality based on received signal information for at least one of the plurality of electrodes.
- Programmer 14 may obtain, via the first screen of the user interface, a selection of one or more of the at least one of the plurality of electrodes as stimulation electrodes.
- Programmer 14 may program, via telemetry circuitry, IMD 16 to provide electrical stimulation according to a stimulation program, the stimulation program defining the stimulation electrodes.
- 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 memory 62.
- Each stored therapy program 74 defines a particular program of therapy in terms of respective values for electrical stimulation parameters, such as an electrode combination to be used as stimulation electrodes, current or Docket No.: A0010290WO01/1123-801WO01 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., frequency) of a stimulation signal.
- Each stored therapy program 74 may also be referred to as a set of stimulation parameter values.
- Operating instructions 76 guide general operation of IMD 16 under control of processing circuitry 60 and may include instructions for monitoring brain signals within one or more brain regions via electrodes 24, 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 recommendation ratings, for one or more electrode combinations of electrodes 24 and/or electrodes 26 to deliver electrical stimulation based on the sensed electrical signals. In some examples, electrode selection algorithm 78 may be executable by processing circuitry 60 to select one or more electrode combinations of electrodes 24 and/or electrodes 26 to deliver electrical stimulation based on input from a user, such as a clinician. [0069] 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, 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, 26, based on one or more stored therapy programs 74.
- therapy programs 74 are chosen at programmer 14 and/or an external computer and transferred to IMD 16 and stored in memory 62.
- the target tissue sites within brain 28 for stimulation signals or other types of therapy and stimulation parameter values may depend on the patient condition for which therapy system 10 is implemented to manage. While stimulation pulses are described, stimulation signals may be of any form, such as continuous-time signals (e.g., sine waves) or the like.
- the processor(s) or processing circuitry described in this disclosure 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 26A–26D.
- Processing circuitry 60 may 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 include individual voltage or current sources and sinks coupled 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 circuitry that may couple stimulation signals to selected conductors within leads 20, that, in turn, deliver the stimulation signals across selected electrodes 24 and/or electrodes 26.
- 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 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 Docket No.: A0010290WO01/1123-801WO01 26.
- the selected electrode combination may be monopolar.
- one or more electrodes e.g., one or more cathodes
- the other 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 selected electrode combination of electrodes 24 and/or electrodes 26 may be unipolar.
- a unipolar selected combination may include one electrode of either electrodes 24 or electrodes 26 in combination with an electrode on the housing of IMD 16 (i.e., case or can), where one is an anode and the other is a cathode.
- 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.
- 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 26 (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.
- Telemetry circuitry 70 in IMD 16, as well as telemetry circuitry in other devices and systems described herein, such as programmer 14, may accomplish communication by RF communication techniques.
- 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 power to various components of IMD 16.
- Power source 72 may include a small rechargeable or non-rechargeable battery and a power Docket No.: A0010290WO01/1123-801WO01 generation circuit to produce the operating power. Recharging may be accomplished through proximal inductive interaction between an external charger and an inductive charging coil within IMD 16. In some examples, power requirements may be small enough to allow IMD 16 to utilize patient motion and implement a kinetic energy-scavenging device to trickle charge a rechargeable battery. In other examples, traditional batteries may be used for a limited period of time.
- 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 circuitry. Accordingly, processing circuitry 80 may include any suitable structure, whether in hardware, software, firmware, or any combination thereof, to perform the functions ascribed herein to processing circuitry 80.
- 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 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.
- Memory 82 may include instructions for operating user interface 86 and telemetry circuitry 84, and for managing power source 88.
- Electrode selection algorithm 87 may be similar to electrode selection algorithm 78 of 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 recommendation rating, for the tested electrodes and transmit the sensed electrical signals and the respective indications of signal quality to programmer 14 via telemetry circuitry 70. In some examples, processing circuitry 60 of IMD 16 may transmit the sensed electrical signals to programmer 14 via telemetry circuitry 70 and processing circuitry 80 may determine the respective indications of signal quality. In either case, processing circuitry 60 (e.g., before transmission) and/or processing circuitry 80 (after receipt) may process the sensed electrical signals, such as to remove noise, improve signal to noise ratio, or the like.
- a respective indication of signal quality such as a recommendation rating
- processing circuitry 80 executing electrode selection algorithm 87 may invoke screen(s) 89 causing processing circuitry 80 to load one or more screens of screen(s) 89 from memory 82 to display 83.
- 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 recommendation rating) for each segmented electrode either of a given level or of all levels, while a levels programming screen may depict a respective indication of signal quality (e.g., a respective recommendation rating) for each level, such as where segmented electrodes are functioning as virtual ring electrodes.
- processing circuitry 80 may store the sensed electrical signals in results 92.
- processing circuitry 80 may store sensed electrical signals Docket No.: A0010290WO01/1123-801WO01 from a plurality of different programming sessions over time in results 92.
- 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 over time. Processing circuitry 80 may, based on determining the change in the sensed electrical signals, provide notification 94 indicative of the change in the sensed electrical signals. It should be noted that the sensed electrical signals may be processed prior to being saved in results 92 and/or may be saved in their raw form.
- stored sensed electrical signals may be said to be representations of electrical signals.
- 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 a clinician or another user may interact with user interface 86 of programmer 14 in other ways to manually select therapy programs, or combinations of electrodes (e.g., stimulation electrodes), generate new therapy programs, modify therapy programs, transmit the new programs to IMD 16, or any combination thereof.
- 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.
- 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.
- 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, 1a-1c, 2a-2c, and 3.
- Electrodes labeled 1a-1c and 2a-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 1a-1c and 2a- 2c may include segmented electrodes and some of segmented electrodes 1a-1c and 2a-2c may be on a back side of the lead represented by representation of lead 402 and therefore unviewable on representation of lead 402.
- Screen 400 also includes a description 410 of the type of therapy program, name and/or ID of the patient for which the therapy program is being generated.
- Screen 400 also Docket No.: A0010290WO01/1123-801WO01 may include an interface 412 from which one of a plurality of screens may be selected.
- screen 400 includes Lead, Annotation, and BrainSense.
- Annotation 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.
- BrainSense 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 of which lead (Left STN) 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.
- 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.
- drop down menu 502 may include an Interface to select the viewing of the indications of signal quality, such as levels of recommendation test results (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 which may include details related to sensed signals, a graph of signal power vs. 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.
- levels of recommendation test results e.g., View Monopolar Results
- a graph of the sensed electrical signals e.g., BrainSense Survey which may include details related to sensed signals, a graph of signal power vs. frequency for each electrode, etc.
- the interface to select the viewing of the levels of recommendation test results may not be operable or displayed. In some examples, if a test has not been conducted, the interface to select the viewing of the levels of recommendation 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 circuitry 80 to send a commend to IMD 16, via telemetry Docket No.: A0010290WO01/1123-801WO01 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 plurality of electrodes and respective levels of recommendations for some of the 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.
- display 83 may display levels of recommendation 602 for each of segmented electrodes 1a- 1c and 2a-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 levels of recommendation are based.
- a selected frequency e.g., 23.82 Hz
- the levels of recommendation may be displayed in a graphical form (shown here as circles). For example, the greater number of circles which may appear filled in, the higher the recommendation may be.
- the levels of recommendation may be represented by color. For example, the circles may be filled in with colors representative of the recommendation rating to further distinguish a higher recommendation rating from a lower recommendation rating.
- segmented electrodes 1a and 1b For example, if all three circles are to be filled in to highly recommend segmented electrodes 1a and 1b, these circles may be filled in with a green color to indicate a high recommendation, while the two circles of segmented electrodes 1c, 2a, and 2b may be filled in with a different color to indicate a medium recommendation, and the one circle of segmented electrode 2c may be filled in with yet another color to indicate a low recommendation.
- the entire representation of the segmented electrode may be colored to represent a respective recommendation rating. Different shapes, colors, or numbers of indicators may be used for the electrodes in other examples.
- FIG.7 is a conceptual diagram illustrating another example user interface results screen displaying a lead including plurality of electrodes and respective levels of recommendations for some of the electrodes in accordance with one or more aspects of this Docket No.: A0010290WO01/1123-801WO01 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 cause display 83 to display screen 700 on display 83.
- FIG.8 is a conceptual diagram illustrating the example user interface results screen of FIG.6 include an indication of user inputs in accordance with one or more aspects of this disclosure.
- Screen 800 may be a screen of screen(s) 89 and include screen 500 with a child window 810 overlaid over screen 500.
- Processing circuitry 80 may cause display 83 to display screen 800 on display 83. For example, if a user selects “Segments” from screen 700, processing circuitry 80 may cause display 83 to display screen 800 on display 83 which breaks out each segmented electrode for each axial level of the lead.
- screen 800 (which may be the same or similar as screen 600), a user may select as stimulation electrodes all of segmented electrodes 1a-1c and electrode 0, or some subset of those electrodes. It should be noted that a user may select any combination of electrodes as stimulation electrodes.
- the levels of recommendation 802 represented in screen 800 may guide the user in selecting which electrodes should be the stimulation electrodes.
- a processing circuitry 80 may present, via user interface 86, a first screen (e.g., screen 800) presenting a representation of a plurality of electrodes and a representation of a respective recommendation rating for at least one of the plurality of electrodes and obtain a selection, via the first screen of the user interface, of one or more of the at least one of the plurality of electrodes as stimulation electrodes.
- FIG.9 is a conceptual diagram illustrating the example user interface results screen of FIGS.6 and 8 including a selection of stimulation electrodes via user input in accordance with one or more aspects of this disclosure.
- Screen 900 may be a screen of screen(s) 89 and include screen 900 with a child window 910 overlaid over screen 900.
- Processing circuitry 80 may cause display 83 to display screen 900 on display 83.
- display 900 may include an indication 902 indicating which electrodes have been selected to be stimulation electrodes, which may be some or all of the segmented electrodes at the same axial level of the lead.
- the user may select which electrode(s) will function as anodes or cathodes and indication 902 may differ based on whether a particular electrode is to be an anode or cathode.
- Screen 900 may include a button to cancel the selected electrodes and a button to update or save the selected electrodes as stimulation electrodes. It should be noted that screen 900 may function similar to screens 700 and 800, facilitating a user selecting stimulation electrodes while viewing representations of levels of recommendation 902. [0101]
- FIG.10 is a conceptual diagram illustrating an example user interface lead screen displaying a lead including selected electrodes as stimulation electrodes and providing an input for other parameters associated with a therapy program 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.
- FIG.11 is a conceptual diagram illustrating an example screen including power spectral densities in accordance with one or more techniques of this disclosure.
- processing circuitry 80 may provide the user with one or more screens (or an interface from which to select one or more screens) such as screen 1310 on display 83.
- Screen 1310 includes a representation of a lead in box 1300 with the bottom electrode of the lead acting as a reference electrode.
- Graph 1302 displays the raw power spectral density of sensed electrical signals using monopolar sensing on a segment-by- segment basis.
- Graph 1304 displays the raw power spectral density of the sensed electrical Docket No.: A0010290WO01/1123-801WO01 signals by the ring electrodes and any segmented electrodes in ring mode using monopolar sensing.
- Graph 1306 displays noise reduced power spectral density of the sensed electrical signals using monopolar sensing on a segment-by-segment basis.
- Graph 1308 displays noise reduced power spectral density of the sensed electrical signals (e.g., processed sensed electrical signals) by the ring electrodes and any segmented electrodes in ring mode using monopolar sensing.
- screen 1310 includes a lot of information. A similar screen may exist for each potential reference electrode.
- the sheer volume of information relating to the sensed electrical signals may make it difficult for a clinician to, based on the information in screen 1310 and each of the other similar screens, select electrodes as stimulation electrodes without error or without taking extensive notes if there were no presentation of indications of signal quality, such as levels of recommendation, on a same screen as the screen used to select the electrodes as stimulation electrodes (e.g., screens 600, 700, 800 or 900 of FIGS.6-9).
- FIG.12 is a flow diagram of an example technique for selecting an electrode combination to deliver electrical stimulation, in accordance with one or more techniques of this disclosure. While described primarily with respect to processing circuitry 80 of FIG.3, it should be noted that the techniques of FIG.12 may be practiced by processing circuitry of any device or combination of devices capable of performing such techniques.
- Processing circuitry 80 may generate, for presentation via a user interface, a first screen presenting a representation of a plurality of electrodes and an indication of signal quality based on received signal information for at least one of the plurality of electrodes (1200). For example, processing circuitry 80 may determine a respective recommendation rating for any of electrodes 24 or 26 (FIG.1). Processing circuitry 80 may generate screen Docket No.: A0010290WO01/1123-801WO01 600, 700, 800, or 900. Screen 600, 700, 800, or 900 may include a representation of respective recommendation rating (e.g., levels of recommendation 602, 702, 802, 902).
- respective recommendation rating e.g., levels of recommendation 602, 702, 802, 902
- Processing circuitry 80 may obtain, via the first screen of the user interface, a selection of one or more of the at least one of the plurality of electrodes as stimulation electrodes (1202). For example, a clinician may select, via screen 600, 700, 800, or 900, one or more electrodes of electrodes 24 or 26 as stimulation electrodes. Processing circuitry 80 may obtain the clinician selection. Obtaining the selection via the first screen is intended to include obtaining the selection from interactions of the clinician with the first screen through any of input device(s) 90 and not just interactions through a touch screen. [0106] Processing circuitry 80 may program, via the telemetry circuitry, an IMD to provide electrical stimulation according to a stimulation program, the stimulation program defining the stimulation electrodes (1204).
- processing circuitry 80 may transmit a therapy program of therapy programs 74 to IMD 16 via telemetry circuitry 84.
- the therapy program may include the identification of the stimulation electrodes.
- the plurality of electrodes e.g., electrodes 24 and/or 26
- the indication of signal quality includes a respective recommendation rating for the at least one segmented electrode.
- the indication of signal quality includes a recommendation rating for a ring electrode or a virtual ring electrode comprising a plurality of segmented electrodes disposed at a same axial position on a lead.
- the indication of signal quality includes at least one of a color or a graphical representation.
- user interface 86 further includes an interface (e.g., interface 412 or drop down menu 502) operable for a user to provide an indication to perform a test on the implantable medical device.
- processing circuitry 80 is further configured to: obtain, from the user, the indication to perform the test; and obtain, via telemetry circuitry 84, results 92 of the test.
- processing circuitry 80 is configured to execute the test to control IMD 16 to sense electrical signals from a plurality of electrode combinations, each of the plurality of electrode combinations including a same reference electrode of a plurality of electrodes and at least one different sense electrode of the plurality of electrodes.
- the electrical signals include monopolar local field Docket No.: A0010290WO01/1123-801WO01 potentials (LFPs).
- results 92 of the test include representations of the electrical signals (e.g., of graphs 1302, 1304, 1306, and 1308), and processing circuitry 80 is further configured to generate the indication of signal quality based on the representations of the electrical signals. In some examples, the indication of signal quality is based on signal strength of one or more of the electrical signals.
- user interface 86 further includes a screen (e.g., screen 1310) including the representations of the electrical signals.
- user interface 86 further includes a representation of at least one of an amplitude, a pulse width, or a frequency associated with the stimulation program (e.g., interface 1006), and processing circuitry 86 is further configured to obtain at the least one of the amplitude, the pulse width, or the frequency associated with the stimulation program from the user via user interface 86.
- processing circuitry 80 is further configured to store the representations of the electrical signals in the memory (e.g., in results 92).
- processing circuitry 80 is further configured to present, via user interface 86, a plurality of the representations of the electrical signals (e.g., results 92) stored over time. In some examples, processing circuitry 80 is further configured to determine a change in the representations of the electrical signals over time, and based on determining the change in the representations of the electrical signals, control user interface 86 to present notification 94 indicative of the change in the representations of the electrical signals. In some examples, providing the notification 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. [0110] In some examples, system 10 and/or programmer 14 includes display 83. In some examples, system 10 includes IMD 16.
- IMD 16 includes stimulation generator 64 and wherein IMD 16 provides the electrical stimulation according to the stimulation program (e.g., of therapy programs 74) via stimulation generator 64 and the stimulation electrodes.
- the stimulation program e.g., of therapy programs 74
- IMD 16 provides the electrical stimulation according to the stimulation program (e.g., of therapy programs 74) via stimulation generator 64 and the stimulation electrodes.
- the systems and techniques described herein may reduce a likelihood a clinician may make an error in programming, reduce the need for the clinician to take notes during a testing and programming session, reduce a cognitive load on the clinician in trying to remember a multitude of results while navigating to a programming screen, and/or reduce an amount of time required to program therapy.
- These techniques are indeed advantageous considering the use of increasing numbers of electrodes on implantable leads (e.g., leads with electrodes disposed at different positions around the perimeter of the lead and at different positions along the length of the lead).
- the techniques and systems described herein may further enable the use of more electrodes that may improve targeting of desired tissue (e.g., specific regions of the brain associated with a disease, symptoms, or therapy) while reducing the time necessary for programming by the clinician.
- the techniques and systems described herein may also further enable the use of different electrode configurations and geometries.
- the techniques described in this disclosure including those attributed to IMD 16, programmer 14, or various constituent components, may be implemented, at least in part, in hardware, software, firmware or any combination thereof.
- 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 code, on a computer- readable medium and executed by a hardware-based processing unit.
- Computer-readable media may include computer-readable storage media forming a tangible, non-transitory medium.
- processors such as one or more DSPs, ASICs, FPGAs, general purpose microprocessors, or other equivalent integrated or discrete logic circuitry.
- processors such as one or more DSPs, ASICs, FPGAs, general purpose microprocessors, or other equivalent integrated or discrete logic circuitry.
- processors such as one or more DSPs, ASICs, FPGAs, general purpose microprocessors, or other equivalent integrated or discrete logic circuitry.
- processors such as one or more DSPs, ASICs, FPGAs, general purpose microprocessors, or other equivalent integrated or discrete logic circuitry.
- 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. Docket No.: A0010290WO01/1123-801WO01 [0114]
- 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
- a medical device system comprising: a memory configured to store a user interface; telemetry circuitry; and processing circuitry coupled to the memory and the telemetry circuitry, the processing circuitry being configured to: generate, for presentation via the user interface, a first screen presenting a representation of a plurality of electrodes and an indication of signal quality based on received signal information for at least one of the plurality of electrodes; obtain, via the first screen of the user interface, a selection of one or more of the at least one of the plurality of electrodes as stimulating electrodes; and program, via the telemetry circuitry, an implantable medical device (IMD) to provide electrical stimulation according to a stimulation program, the stimulation program defining the stimulation electrodes.
- IMD implantable medical device
- Example 1 The medical device system of example 1, wherein the plurality of electrodes comprise at least one segmented electrode that is disposed at a partial perimeter around a lead.
- Example 3 The medical device system of example 2, wherein the indication of signal quality comprises a respective recommendation rating for the at least one segmented electrode.
- Example 4 The medical device system of example 2, wherein the indication of signal quality comprises a recommendation rating for a ring electrode or a Docket No.: A0010290WO01/1123-801WO01 virtual ring electrode comprising a plurality of segmented electrodes disposed at a same axial position on a lead. [0120] Example 5.
- Example 6 The medical device system of any of examples 1-4, wherein indication of signal quality comprises at least one of a color or a graphical representation.
- Example 6 The medical device system of any of examples 1-5, wherein the user interface further comprises an interface operable for a user to provide an indication to perform a test on the implantable medical device and wherein the processing circuitry is further configured to: obtain, from the user, the indication to perform the test; and obtain, via the telemetry circuitry, results of the test.
- Example 7 Example 7.
- Example 8 The medical device system of example 7, wherein the electrical signals comprise local field potentials (LFPs).
- Example 9 The medical device system of example 7 or example 8, wherein the results of the test comprise representations of the electrical signals, and wherein the processing circuitry is further configured to generate the indication of signal quality based on the representations of the electrical signals.
- Example 11 The medical device system of example 9 or example 10, wherein the user interface further comprises a screen comprising the representations of the electrical signals.
- Example 12 The medical device system of any of examples 1-11, wherein the user interface further comprises a representation of at least one of an amplitude, a pulse width, or a frequency associated with the stimulation program, and wherein the processing circuitry is further configured to obtain at the least one of the amplitude, the pulse width, or the frequency associated with the stimulation program from the user via the user interface.
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Abstract
Devices, systems, and techniques are described for generating and presenting recommendation ratings for different potential stimulation electrodes. An example system includes memory configured to store the user interface, telemetry circuitry, and processing circuitry coupled to the memory and the telemetry circuitry. The processing circuitry is configured to generate, for presentation via the user interface, a first screen presenting a representation of a plurality of electrodes and an indication of signal quality based on received signal information for at least one of the plurality of electrodes. The processing circuitry is configured to obtain, via the first screen, a selection of one or more of the at least one of the plurality of electrodes as stimulation electrodes. The processing circuitry is configured to program, via the telemetry circuitry, an implantable medical device to provide electrical stimulation according to a stimulation program, the stimulation program defining the stimulation electrodes.
Description
Docket No.: A0010290WO01/1123-801WO01 ELECTRODE SENSING RESULTS INTEGRATED WITH ELECTRODE ASSIGNMENT [0001] This application is a PCT application that claims priority to, and the benefit of, U.S. Provisional Patent Application No.63/516,455, filed July 28,2023, the entire contents of which is incorporated herein by reference. TECHNICAL FIELD [0002] The disclosure relates to medical devices, and more specifically, sensing electrical signals from a patient. BACKGROUND [0003] Implantable medical devices, such as electrical stimulators or therapeutic agent delivery devices, have been proposed for use in different therapeutic applications, such as deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, functional electrical stimulation or delivery of pharmaceutical agents, insulin, pain relieving agents or anti-inflammatory agents to a target tissue site within a patient. In some therapy systems, an implantable electrical stimulator delivers electrical therapy to a target tissue site within a patient with the aid of two or more electrodes, that may be deployed by medical leads and/or on a housing of the electrical stimulator, or both. In some therapy systems, therapy may be delivered via particular combinations of the electrodes carried by leads and/or by the housing of the electrical stimulator. [0004] During a programming session, that may occur during implantation of the medical device, during a trial session, or during an in-clinic or remote follow-up session after the medical device is implanted in the patient, a clinician may generate one or more therapy programs (also referred to as therapy parameter sets) that are found to provide efficacious therapy to the patient, where each therapy program may define values for a set of therapy parameters. A medical device may deliver therapy to a patient according to one or more stored therapy programs. In the case of electrical stimulation, the therapy parameters may define characteristics of the electrical stimulation waveform to be delivered. In examples in that electrical stimulation is delivered in the form of electrical pulses, for example, the
Docket No.: A0010290WO01/1123-801WO01 therapy parameters may include an electrode configuration including a stimulating electrode combination and electrode polarities, an amplitude, that may be a current or voltage amplitude, a pulse width, and a pulse rate. SUMMARY [0005] In general, this disclosure is directed to devices, systems, and methods for presenting and receiving information relating to programming of therapy parameters, such as stimulating electrode(s) and/or electrode segment(s) (which may be considered electrodes, for the purposes of this disclosure), within a system that may utilize sensed signals, such as LFPs (local field potentials), evoked compound action potential (eCAP), or other evoked response, to identify electrodes on one or more implantable leads that may be most appropriate for delivery of stimulation. [0006] For example, a system is configured to receive sensed signals and identify, based on the signals, electrodes on one or more implantable leads that may be most appropriate for delivery of stimulation. The system may sense signals between each electrode on a lead using a particular electrode as a reference (e.g., a reference electrode). Such sensing may be referred to as monopolar sensing when the spacing between sensing electrodes is significantly greater than the spatial extent of the signal source. For example, monopolar sensing may include sensing when the spacing between sensing electrodes is in the range of 30 – 40 mm or greater than the spatial extent of the signal source, which may be in the range of 3 – 9 mm. In some examples, the reference electrode is an electrode on a different lead than the lead including the sense electrode(s). In some examples, the reference electrode may be a distal most or proximal most electrode on the same lead as the sensing electrodes. In some examples, the system may perform the sensing of signals in this manner on each lead of the system. In this manner, the system may sense signals between different electrodes in order to highlight relevant differences between stimulation delivered via each of the electrodes. [0007] The system may determine indications of signal quality based on received signal information, which may include levels of recommendation or recommendation ratings, for electrodes based on the sensed signals and present the indications of signal quality on a programming screen where the clinician may select which electrodes are to be used as
Docket No.: A0010290WO01/1123-801WO01 stimulation electrodes. For example, the indications of signal quality may be integrated into a same screen from which a user may select the electrodes to be used as stimulation electrodes. The clinician may then select which electrodes are to be used as stimulation electrodes for a given therapy program while simultaneously viewing the indications of signal quality via the programming screen. [0008] As one example, a medical device system includes: a memory configured to store a user interface; telemetry circuitry; and processing circuitry coupled to the memory and the telemetry circuitry, the processing circuitry being configured to: generate, for presentation via the user interface, a first screen presenting a representation of a plurality of electrodes and an indication of signal quality based on received signal information for at least one of the plurality of electrodes; obtain, via the first screen of the user interface, a selection of one or more of the at least one of the plurality of electrodes as stimulating electrodes; and program, via the telemetry circuitry, an implantable medical device (IMD) to provide electrical stimulation according to a stimulation program, the stimulation program defining the stimulation electrodes. [0009] As another example, a method includes generating, for presentation via a user interface, a first screen presenting a representation of a plurality of electrodes and an indication of signal quality based on received signal information for at least one of the plurality of electrodes; obtaining, via the first screen of the user interface, a selection of one or more of the at least one of the plurality of electrodes as stimulating electrodes; and programing, via the telemetry circuitry, an implantable medical device (IMD) to provide electrical stimulation according to a stimulation program, the stimulation program defining the stimulation electrodes. [0010] As another example, a non-transitory computer-readable storage medium stores instructions that, when executed, cause processing circuitry to: generate, for presentation via a user interface, a first screen presenting a representation of a plurality of electrodes and an indication of signal quality based on received signal information for at least one of the plurality of electrodes; obtain, via the first screen of the user interface, a selection of one or more of the at least one of the plurality of electrodes as stimulating electrodes; and program, via the telemetry circuitry, an implantable medical device (IMD) to provide electrical
Docket No.: A0010290WO01/1123-801WO01 stimulation according to a stimulation program, the stimulation program defining the stimulation electrodes. [0011] The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF DRAWINGS [0012] 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. [0013] FIG.2 is functional block diagram illustrating components of an example medical device in accordance with one or more aspects of this disclosure. [0014] 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. [0015] FIG.4 is a conceptual diagram illustrating an example user interface lead screen displaying a representation of a lead including plurality of electrodes in accordance with one or more aspects of this disclosure. [0016] 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. [0017] FIG.6 is a conceptual diagram illustrating an example user interface results screen displaying a lead including plurality of electrodes and respective levels of recommendations or recommendation ratings for some of the electrodes in accordance with one or more aspects of this disclosure. [0018] FIG.7 is a conceptual diagram illustrating another example user interface results screen displaying a lead including plurality of electrodes and respective levels of recommendations or recommendation ratings for some of the electrodes in accordance with one or more aspects of this disclosure. [0019] FIG.8 is a conceptual diagram illustrating the example user interface results screen of FIG.6 include an indication of user inputs in accordance with one or more aspects of this disclosure.
Docket No.: A0010290WO01/1123-801WO01 [0020] FIG.9 is a conceptual diagram illustrating the example user interface results screen of FIGS.6 and 8 including a selection of stimulation electrodes via user input in accordance with one or more aspects of this disclosure. Screen 900 may be a screen of screen(s) 89. [0021] FIG.10 is a conceptual diagram illustrating an example user interface lead screen displaying a lead including selected electrodes as stimulation electrodes and providing an input for other parameters associated with a therapy program in accordance with one or more aspects of this disclosure. [0022] FIG.11 is a conceptual diagram illustrating an example screen including power spectral densities in accordance with one or more techniques of this disclosure. [0023] FIG.12 is a flow diagram of an example technique for selecting an electrode combination to deliver electrical stimulation, in accordance with one or more techniques of this disclosure. DETAILED DESCRIPTION [0024] When a clinician programs a therapy program, such as a stimulation program, for an implantable medical device (IMD), the clinician may test each possible combination of electrodes which may be used as stimulation electrodes for the stimulation program. For example, a clinician may use sensed signals to determine which combination of electrodes is to be used as stimulation electrodes. As the number of electrodes being used with IMDs has grown and the use of segmented electrodes has become more widespread, this programming has become more difficult with a dramatic increase in the number of possible combinations of electrodes to be used as stimulation electrodes. Analyzing and retaining the sensed signals is not possible in the mind of a human being, particularly for systems using a large number of electrodes and/or segmented electrodes. [0025] In general, this disclosure is directed to providing a user interface that may facilitate a clinician viewing suggested or recommended electrodes for use as stimulation electrodes on a same screen as for programming electrodes as stimulation electrodes. Providing information regarding which electrodes are suggested to be used as stimulation electrodes on a same screen where a clinician may program electrodes as stimulation electrodes may simplify the programming process. For example, by providing detailed test
Docket No.: A0010290WO01/1123-801WO01 results which a clinician may analyze for each of a large number of electrodes and requiring a clinician to navigate to other screens to select the desired electrodes for use as stimulation electrodes may be complicated. A human may not be capable of retaining all of the information provided on the various test result screens in their mind as they navigate to one or more other screens from which to select electrodes as stimulation electrodes for a given therapy program. The use of LFPs to identify electrodes on one or more implantable leads that may be most appropriate for delivery of stimulation is discussed in U.S. Patent Publication 2022-0387802 A1, which is hereby incorporated by reference in its entirety. The techniques of this disclosure may be particularly useful with such a system. [0026] The indications of signal quality, such as a recommendation of electrodes for use as stimulation electrodes, generated by the system stimulation electrodes may be based on the utilization of sensed electrical signals, such as LFPs within the brain, to identify which electrodes of a plurality of electrodes, for example, of an implanted lead, may be appropriate to deliver electrical stimulation for a given therapy program. In some examples, the system may generate an indication of signal quality for some or all of the electrodes. The recommendation for these electrodes may be based on this signal quality associated with the electrode. The signal quality may be representative of characteristics of the sensed signal from the electrode, such as signal amplitude (e.g., total amplitude or amplitude from one or more frequency bands), noise present in the signal, etc. While primarily described herein with respect to a brain, the techniques of this disclosure may be used to identify which electrodes may be appropriate to deliver electrical stimulation to other parts of the anatomy, such as the spinal cord, pelvic floor, peripheral nerves, and the like. [0027] Many brain disorders may be associated with abnormal brain function. In one example, Parkinson’s Disease (PD) is a progressive neuro-degenerative disorder characterized by the depletion of dopaminergic neurons in the basal ganglia-thalamo-cortical network. As PD progresses, the manifestations of the disease may include one or more of the characteristic motor dysfunctions that include one or more of akinesia, bradykinesia, rigidity, and tremor. In some examples, deep brain stimulation (DBS) therapy may be used to deliver electrical stimulation to treat motor symptoms in medication-refractory PD patients. In some examples, DBS therapy may involve the unilateral or bilateral implantation of one or more leads into the brain to deliver electrical stimulation to target structures in the basal ganglia.
Docket No.: A0010290WO01/1123-801WO01 Selection of effective stimulation parameters for DBS therapy may be time-consuming for both the clinician (e.g., a physician, nurse, or technician) and the patient. As such, it may be desirable to reduce the amount of time consumed to select stimulation parameters. In addition, the trial-and-error approach for determining appropriate electrode combinations and/or other stimulation parameters may subject the patient to undesirable side effects during this lengthy process and/or may result in less than optimal stimulation parameters, thus lessening the therapeutic value of any therapy delivered. [0028] The target region associated with a disease (e.g., PD) may generate signals of interest (e.g., Beta waves that may be indicative of symptoms such as tremor in PD). As described herein, a system may sense 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 signal quality which may include a recommendation), such as information that may be presented to a clinician and/or information used by the system to select parameter values for stimulation such which of the electrodes should serve as two or more stimulation electrodes. The sensed signals may be between electrodes at different circumferential positions and/or electrodes at different axial positions on one lead and a reference electrode on another lead (e.g., monopolar sensing). The clinician, or the system, may then determine parameters for stimulation based on one or more characteristics of these obtained signals instead of having to test stimulation provided by each electrode combination. For example, parameters for stimulation may include which electrodes are to be used for stimulation, a polarity of the electrodes used for stimulation (e.g., anode or cathode), and parameters of the electrical stimulation signal, such as voltage or current amplitude, frequency, waveform shape, on/off cycling state (e.g., if cycling is “off,” stimulation is always on, and if cycling is “on,” stimulation is cycled on and off) and, in the case of electrical stimulation pulses, current or voltage pulse amplitude, pulse rate, pulse width, and other appropriate parameters such as duration or duty cycle. Such parameters may be applicable to a given therapy program. It should be noted that an IMD may include a plurality of therapy programs which may include at least some parameters which are different than parameters of each other therapy program. [0029] For example, a Beta rhythm may be localized with the dorsal subthalamic nucleus (STN). It may be helpful to select stimulation electrodes that may generate an electric field
Docket No.: A0010290WO01/1123-801WO01 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. The system may then identify the electrode combinations, and thus axial (or level) and circumferential positions of the electrode combinations, associated with the spectral power characteristics indicative of stronger Beta waves. In some examples, the system may recommend the electrode combination associated with stronger Beta waves for targeted stimulation to this region of tissue. In addition, or alternatively, the system may present summary information relating to signal quality, such as levels of recommendation or recommendation ratings, to a clinician for different electrodes to enable the clinician to easily select which electrodes the clinician desires to use as stimulation electrodes. The signal quality and/or recommendation ratings may be based on sensed LFPs (and/or characteristics such as spectral power) from different electrode combinations. The sensed LFPs may also be available for viewing by the clinician should the clinician desire to do so. In other examples, the signal quality and/or recommendation ratings may be based on other sensed signals, such as eCAPs or other evoked responses. [0030] The system may provide the summary information based on the sensed LFPs, such as via a colored representation, a graphical representation (such as a number of dots, a sliding scale, or the like), or other representation which may distinguish between more highly recommended and less highly recommended electrodes for use as stimulation electrodes. Such summary information may be presented on a same screen upon which a clinician may select or program an electrode as a stimulating electrode. In this manner, 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 (e.g., recommendation ratings) for the stimulation electrodes. [0031] Each lead may have electrodes disposed at different axial (e.g., longitudinal) positions along the length of the lead. These electrodes may be ring electrodes and/or segmented electrodes that only reside around a limited portion of the perimeter of the lead. In the case of segmented electrodes that only reside around a limited portion of the perimeter
Docket No.: A0010290WO01/1123-801WO01 of the lead, at a given axial position, each lead may have electrodes at different circumferential positions (e.g., at different positions around the perimeter of the lead). Hence, two or more segmented electrodes may be positioned at the same axial position along the length of the lead (e.g., on the same level of the lead). As an illustration, a 1-3-3-1 lead would have, in order, a ring electrode at a first, most proximal axial level, three segmented electrodes at different circumferential positions of a second, more distal axial level, three segmented electrodes at different circumferential positions of a third, still more distal axial level, and a ring electrode at a fourth, most distal axial level. In some examples, the system may group electrodes together as one polarity, e.g., as a group of cathodes, for use with another electrode of another polarity, e.g., an anode, or vice versa. The system may perform such groupings in order to balance impedance between cathodes and anodes and improve sensing fidelity. In one example, to sense between an axial level of the lead with a ring electrode and another axial level with multiple smaller, segmented electrodes at different circumferential positions, the system may group together those electrodes at different circumferential positions to create a virtual ring electrode (also referred to herein as segmented electrodes in a ring mode) that may improve sensing between an actual ring electrode and the virtual ring electrode. The grouping together of those electrodes at different circumferential positions to create a virtual ring electrode may be referred to as a ring mode. [0032] Sensing electrical signals between different electrodes, including electrodes at different axial positions and at different circumferential positions, may provide valuable information about where certain electrical signals (e.g., signals in the Beta frequency band or Beta waves, alpha waves, gamma waves, theta waves, and high frequency oscillations (HFO)) are originating from within tissue. In this manner, the system (or a clinician) may use this information to determine which electrodes (and/or other stimulation parameter values) should be used to deliver electrical stimulation therapy. The system may provide information representative of the sensed electrical signals via a display to enable a clinician to program stimulation more effectively and in less time than using trial-and-error approaches. [0033] In general, as part of generating the one or more therapy programs, a clinician may select which electrodes to use for stimulation. For example, a clinician may utilize the
Docket No.: A0010290WO01/1123-801WO01 medical device to record sensed electrical signals between different pairs of electrodes on a single lead (e.g., bipolar sensing) and a display to display representations of the recorded bipolar sensed electrical signals. However, generating the one or more therapy programs based on the representations of the recorded bipolar sensed electrical signals may not be intuitive for many clinicians. Additionally, bipolar sensing may be susceptible to electrocardiogram artifacts which may result in noisy sensed electrical signals, further complicating the stimulation electrode selection process. [0034] Alternatively, as part of generating the one or more therapy programs, a clinician may perform a review to test each electrode and the effect of stimulating using each electrode on the symptoms of a patient. However, this process may take as several hours and be uncomfortable for the patient. [0035] Moreover, even with systems that may provide monopolar sensing results to a clinician when determining one or more therapy programs, such results may not be provided in such a manner that a clinician may easily select appropriate electrodes as stimulation electrodes based on the results. [0036] According to the techniques of this disclosure, a medical device may generate, for presentation via a user interface, a first screen presenting an indication of signal quality based on received signal information for at least one of the plurality of electrodes. The medical device may obtain, via the first screen of the user interface, a selection of one or more of the at least one of the plurality of electrodes as stimulation electrodes. The medical device may program, via the telemetry circuitry, an implantable medical device (IMD) to provide electrical stimulation according to a stimulation program, the stimulation program defining the stimulation electrodes. [0037] By providing a screen of a user interface that includes indications of signal quality, such as representations of respective recommendation ratings, and obtains a selection of electrodes as stimulation electrodes, the techniques of this disclosure may streamline selection of stimulation electrodes and/or reduce a likelihood that a clinician may misremember, mistranscribe, or otherwise make an error which may result in the incorrect programming of a therapy program for an IMD. As a result, the techniques of this disclosure may result in improved patient outcomes (e.g., more efficacious therapy), reduced clinician and patient time associated with programming an IMD, and/or the like.
Docket No.: A0010290WO01/1123-801WO01 [0038] FIG.1 is a conceptual diagram illustrating an example therapy system 10 that is configured to deliver therapy to patient 12 to manage a disorder of patient 12. Patient 12 ordinarily will be a human patient. In some cases, however, therapy system 10 may be applied to other mammalian or non-mammalian non-human patients. In the example shown in FIG.1, therapy system 10 includes medical device programmer 14, implantable medical device (IMD) 16, lead extension 18, and one or more leads 20A and 20B (collectively “leads 20”) with respective sets of electrodes 24, 26. IMD 16 includes a stimulation generator (not shown in FIG.1) configured to generate and deliver electrical stimulation therapy to the STN region of brain 28 of patient 12 via electrodes 24 and/or 26 of leads 20A and 20B, respectively. [0039] In the example shown in FIG.1, therapy system 10 may be referred to as a deep brain stimulation (DBS) system because IMD 16 is configured to deliver electrical stimulation therapy directly to the STN within brain 28. DBS may be used to treat or manage various patient conditions, such as, but not limited to, seizure disorders (e.g., epilepsy), pain, migraine headaches, psychiatric disorders (e.g., major depressive disorder (MDD), bipolar disorder, anxiety disorders, post-traumatic stress disorder, dysthymic disorder, and obsessive compulsive disorder (OCD)), behavior disorders, mood disorders, memory disorders, mentation disorders, 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. [0040] In the example shown in FIG.1, IMD 16 may be implanted within a subcutaneous pocket in the pectoral region of patient 12. In other examples, IMD 16 may be implanted within other regions of patient 12, such as a subcutaneous pocket in the abdomen or buttocks of patient 12 or proximate the cranium of patient 12. Implanted lead extension 18 is coupled to circuitry in IMD 16 via proximal electrical contacts that connect to electrical terminals in connector block 30 (also referred to as a header). Lead extension 18 may include, for example, distal electrical contacts that electrically couple to proximal electrical contacts of leads 20A, 20B, which in turn may be coupled to respective electrodes 24, 26 via conductors within leads 20A, 20B. The proximal electrical contacts of leads 20A, 20B and the distal electrical contacts of lead extension 18 electrically couple the electrodes 24, 26 carried by leads 20 to the proximal contacts of lead extension 18 via conductors within the lead
Docket No.: A0010290WO01/1123-801WO01 extension 18, and in turn to circuitry of IMD 16 via terminals in connector block 30. Lead extension 18 traverses from the implant site of IMD 16 within a chest cavity of patient 12, along the neck of patient 12 and through the cranium of patient 12 to access brain 28. IMD 16 may be constructed of a biocompatible material that resists corrosion and degradation from bodily fluids. IMD 16 may comprise a hermetically sealed housing 34 to substantially enclose components, such as a processor, therapy circuitry, and memory. [0041] In the example shown in FIG.1, leads 20 are implanted within the right and left hemispheres, respectively, of brain 28 in order to deliver electrical stimulation to one or more regions of brain 28, that may be selected based on many factors, such as the type of patient condition that therapy system 10 is implemented to manage. Other implant sites for leads 20 and IMD 16 are contemplated. For example, IMD 16 may be implanted on or within cranium 32 or leads 20 may be implanted within the same hemisphere at multiple target tissue sites or IMD 16 may be coupled to a single lead that is implanted in one or both hemispheres of brain 28. [0042] Leads 20 may be positioned to deliver electrical stimulation to one or more target tissue sites within brain 28 to manage patient symptoms associated with a disorder of patient 12. Leads 20 may be implanted to position electrodes 24, 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, 26 are capable of providing electrical stimulation to target therapy delivery sites within brain 28 during treatment. In the case of Parkinson’s disease, for example, leads 20 may be implanted to deliver electrical stimulation to regions within the STN, either unilaterally or bilaterally. Target therapy delivery sites not located in brain 28 of patient 12 are also contemplated. [0043] Although leads 20 are shown in FIG.1 as being coupled to a common lead extension 18, in other examples, leads 20 may be coupled to IMD 16 via separate lead extensions or directly coupled to IMD 16. Moreover, although FIG.1 illustrates therapy system 10 as including two leads 20A and 20B coupled to IMD 16 via lead extension 18, in some examples, therapy system 10 may include one lead or more than two leads. [0044] In the examples shown in FIG.1, electrodes 24A, 24D, 26A, and 26D of leads 20 are shown as ring electrodes. Ring electrodes may be relatively easy to program and may be
Docket No.: A0010290WO01/1123-801WO01 capable of delivering an electrical field to any tissue adjacent to leads 20. Electrodes 24B, 24C, 26B, and 26C of leads 20 may have different configurations. For example, electrodes 24B, 24C, 26B, and 26C of leads 20 may each have a complex electrode array geometry that is capable of producing shaped electrical fields. An example of a complex electrode array geometry may include an array of segmented electrodes positioned at different axial positions along the length of a lead, as well as at different angular (i.e., circumferential) positions about the periphery, e.g., circumference, of the lead.^^The complex electrode array geometry may include multiple electrodes (e.g., partial ring or segmented electrodes), such as electrode 24B, 24C, 26B, and 26C that each include multiple individually programmable electrodes located at different positions around the perimeter of each respective lead 20. Although electrodes 24A, 24D, 26A, and 26D may be ring electrodes that each extend fully around the perimeter of the lead, any of these electrodes may be replaced, in other examples, by multiple electrodes located at different positions around the perimeter of the lead. Although electrodes 24B, 24C, 26B, and 26C may be include multiple electrodes (e.g., partial ring electrodes or segmented electrodes), any of these electrodes may be replaced by ring electrodes. By using electrodes disposed at different positions around the perimeter of the lead, IMD 16 may deliver directional stimulation, with electrical stimulation that may be directed in a specific direction from leads 20 to enhance therapy efficacy and reduce possible adverse side effects from stimulating a large volume of tissue. As a further example, the electrodes may be pad electrodes, that may be carried on a paddle lead or a cylindrical lead. [0045] As illustrated in the example of FIG.1, 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 may include electrodes 26A, 26B, 26C, and 26D. In some examples, each of electrodes 24 and 26 may be configured to independently deliver electrical stimulation. [0046] In some examples, outer housing 34 of IMD 16 may include one or more stimulation and/or sensing electrodes. Some or all of the electrodes may be used for both sensing and stimulation, or some electrodes may be dedicated to sensing while some other electrodes may be dedicated to stimulation. Housing 34 may comprise an electrically conductive material that is exposed to tissue of patient 12 when IMD 16 is implanted in patient 12, or an electrode may be attached to housing 34. Hence, in some examples, electrode combinations for stimulation and/or sensing may be formed by combinations of one
Docket No.: A0010290WO01/1123-801WO01 or more electrodes on a lead or leads and one or more electrodes on housing 34 of IMD 16, or by combinations of two or more electrodes on a lead or leads. In other examples, leads 20 may have shapes other than elongated cylinders as shown in FIG.1 with active or passive tip configurations. For example, leads 20 may be paddle leads, spherical leads, bendable leads, or any other type of shape effective in treating patient 12. [0047] 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, 26. The electrical stimulation parameters may define an aspect of the electrical stimulation therapy, and may include, for example, voltage or current amplitude of an electrical stimulation signal, a charge level of an electrical stimulation, a frequency of the electrical stimulation signal, waveform shape, on/off cycling state (e.g., if cycling is “off,” stimulation is always on, and if cycling is “on,” stimulation is cycled on and off) and, in the case of electrical stimulation pulses, current or voltage pulse amplitude, pulse rate, pulse width, and other appropriate parameters such as duration or duty cycle. In addition, if different electrodes are available for delivery of stimulation, an electrode combination may further characterize a therapy parameter of a therapy program, that may define selected electrodes 24, 26 and their respective polarities. In some examples, stimulation may be delivered using a continuous waveform and the stimulation parameters may define this waveform, although stimulation will generally be described herein as being defined by stimulation pulses. [0048] In addition to being configured to deliver therapy to manage a disorder of patient 12, therapy system 10 may be configured to sense bioelectrical brain signals or another physiological parameter of patient 12. For example, IMD 16 may include a sensing circuitry that is configured to sense bioelectrical brain signals within one or more regions of brain 28 via a subset of electrodes 24, 26, another set of electrodes, or both. Accordingly, in some examples, electrodes 24, 26 may be used to deliver electrical stimulation from the stimulation generator to target sites within brain 28 as well as sense brain signals within brain 28. However, IMD 16 may also use a separate set of sensing electrodes to sense the bioelectrical
Docket No.: A0010290WO01/1123-801WO01 brain signals. In some examples, the sensing circuitry of IMD 16 may sense bioelectrical brain signals via one or more of the electrodes 24, 26 that are also used to deliver electrical stimulation to brain 28. In other examples, one or more of electrodes 24, 26 may be used to sense bioelectrical brain signals while one or more different electrodes 24, 26 may be used to deliver electrical stimulation. [0049] Programmer 14 is an external device that is configured to wirelessly communicate with IMD 16 as needed to provide or retrieve therapy information. Programmer 14 is an external computing device that the user, e.g., the clinician and/or patient 12, may use to communicate with IMD 16. For example, programmer 14 may be a clinician programmer that the clinician uses to communicate with IMD 16 and program one or more therapy for IMD 16. In addition, or instead, programmer 14 may be a patient programmer that allows patient 12 to select programs and/or view and modify therapy parameter values. The clinician programmer may include more programming features than the patient programmer. In other words, more complex or sensitive tasks may only be allowed by the clinician programmer to prevent an untrained patient from making undesired changes to IMD 16. [0050] Programmer 14 may be a hand-held computing device with a display viewable by the user and an interface for providing input to programmer 14 (i.e., a user input mechanism). For example, programmer 14 may include a small display screen (e.g., a liquid crystal display (LCD) or a light emitting diode (LED) display) that presents information to the user. In addition, programmer 14 may include a touch screen display, keypad, buttons, a peripheral pointing device, voice activation, or another input mechanism that allows the user to navigate through the user interface of programmer 14 and provide input. If programmer 14 includes buttons and a keypad, the buttons may be dedicated to performing a certain function, e.g., a power button, the buttons and the keypad may be soft keys that change in function depending upon the section of the user interface currently viewed by the user, or any combination thereof. [0051] In other examples, programmer 14 may be a larger workstation or a separate application within another multi-function device, rather than a dedicated computing device. For example, the multi-function device may be a notebook computer, tablet computer, workstation, one or more servers, cellular phone, personal digital assistant, or another
Docket No.: A0010290WO01/1123-801WO01 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. [0052] 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, 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, 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, 26 of leads 20). [0053] 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/identification of therapy programs by providing a system for identifying potentially beneficial therapy parameter values. For example, during a programming session, the physician may select an electrode combination for delivery of therapy to the patient. The physician may have the option to create several therapy programs. Some programs may have the same electrode combination to be used as stimulation electrodes (but different values of at least one other therapy parameter) and these therapy programs may be organized into subsets, each subset having the same electrode combination. The physician may select an efficacious therapy program for each subset based on a displayed list of sensed LFP signals from electrode combinations. The clinician may select a therapy program based on a list displayed on external programmer 14 of combinations of electrodes providing the largest LFP spectral power to provide therapy to patient 12 to address symptoms associated with the patient condition. [0054] Programmer 14 may also be configured for use by patient 12. When configured as a patient programmer, programmer 14 may have limited functionality (compared to a clinician programmer) in order to prevent patient 12 from altering critical functions of IMD 16 or applications that may be detrimental to patient 12. [0055] Whether programmer 14 is configured for clinician or patient use, programmer 14 is configured to communicate with IMD 16 and, optionally, another computing device, via
Docket No.: A0010290WO01/1123-801WO01 wireless communication. Programmer 14, for example, 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. Programmer 14 may also communicate with another programmer or computing device via a wired or wireless connection using any of a variety of local wireless communication techniques, such as RF communication according to the 802.11 or Bluetooth specification sets, infrared (IR) communication according to the IRDA specification set, or other standard or proprietary telemetry protocols. Programmer 14 may also communicate with other programming or computing devices via exchange of removable media, such as magnetic or optical disks, memory cards, or memory sticks. Further, programmer 14 may communicate with IMD 16 and another programmer via remote telemetry techniques known in the art, communicating via a personal area network (PAN), a local area network (LAN), wide area network (WAN), public switched telephone network (PSTN), or cellular telephone network, for example. [0056] Therapy system 10 may be implemented to provide chronic stimulation therapy to patient 12 over the course of several months or years. However, therapy system 10 may also be employed on a trial basis to evaluate therapy before committing to full implantation. If implemented temporarily, some components of therapy system 10 may not be implanted within patient 12. For example, patient 12 may be fitted with an external medical device, such as a trial stimulator, rather than IMD 16. The external medical device may be coupled to percutaneous leads or to implanted leads via a percutaneous extension. If the trial stimulator indicates therapy system 10 provides effective treatment to patient 12, the clinician may implant a chronic stimulator within patient 12 for relatively long-term treatment. In another example, a clinician in an operating room may obtain acute recordings during lead placement and before coupling the lead with an IMD. In this example, an external device (e.g., an external electrophysiology system) may couple to the medical lead in order to obtain sensed electrical signals. [0057] While DBS may successfully reduce symptoms of some neurological diseases, the stimulation may also cause unwanted side effects, also referred to herein as adverse effects. Side effects may include incontinence, tingling, loss of balance, paralysis, slurred speech, loss of memory, loss of inhibition, and many other neurological problems. Side effects may
Docket No.: A0010290WO01/1123-801WO01 be mild to severe. DBS may cause one or more adverse effects by inadvertently providing electrical stimulation pulses to anatomical regions near the targeted anatomical region. These anatomical regions may be referred to as regions associated with adverse stimulation effects. For this reason, a clinician may program IMD 16 with a therapy program (or a plurality of therapy programs) that defines stimulation parameter values that balance effective therapy and minimize side effects. For example, a clinician may select electrodes to deliver stimulation that did not sense the 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. [0058] With the aid of programmer 14 or another computing device, a clinician may select values for therapy parameters for therapy system 10, including an electrode combination to be used as stimulation electrodes. By selecting particular electrodes of electrodes 24, 26 and electrode combinations for delivering electrical stimulation therapy to patient 12, a clinician may modify the electrical stimulation therapy to target one or more particular regions of tissue (e.g., specific anatomical structures) within brain 28 and avoid other regions of tissue within brain 28. In addition, by selecting values for the other stimulation parameter values that define the electrical stimulation signal, e.g., the amplitude, pulse width, and pulse rate, the clinician may generate an efficacious therapy for patient 12 that is delivered via the selected electrode subset. Due to physiological diversity, condition differences, and inaccuracies in lead placement, the parameter values may vary between patients. [0059] During a programming session, the clinician may determine one or more therapy programs that may provide effective therapy to patient 12. Patient 12 may provide feedback to the clinician as to the efficacy of the specific program being evaluated, that may include information regarding adverse effects of delivery of therapy according to the specific program. In some examples, the patient feedback may be used to determine a clinical rating scale score. Once the clinician has identified one or more programs that may be beneficial to patient 12, patient 12 may continue the evaluation process and determine which program best alleviates the condition of patient 12 or otherwise provides efficacious therapy to patient 12.
Docket No.: A0010290WO01/1123-801WO01 Programmer 14 may assist the clinician in the creation/identification of therapy programs by providing a methodical system of identifying potentially beneficial therapy parameters. [0060] In another example, lead 20 may be implanted directly at the target tissue (e.g., in a region with the strongest beta oscillation or largest amplitude of a target frequency). In another example, lead 20 may be implanted based purely on anatomy alone (e.g., placed in the STN). In either of these examples, due to various uncertainties associated with the lead placement procedure, the location of the medical lead may not be the same as the region generating the maximal signal source, resulting in an offset between the target anatomy and the lead location. However, it is not necessary for lead 20 to be offset from the target anatomy as a lead placed at the target tissue that generates the strongest signal may provide effective stimulation therapy. A clinician may choose to implant lead 20 offset from target tissue or directly at or within the target tissue that generates the strongest signal. [0061] When using medical leads with larger number of electrodes, the time necessary for a review by a clinician grows. Further, the exploration and programming time required for directional stimulation across multiple combinations of electrodes increases as well. To reduce the time required of the patient and the clinician, in some examples, a representation of a level of recommendation or recommendation rating based on sensed electrical signals sensed by multiple combinations of electrodes may be displayed to the clinician. The clinician may then select, or the system may automatically select, electrodes to provide electrical stimulation based on the sensed signals (e.g., the electrodes that sensed the greatest signal strength). [0062] In some examples, IMD 16 includes sensing circuitry configured to sense electrical signals from a first plurality of electrode combinations, each of the first plurality of electrode combinations comprising a same reference electrode of a first lead and at least one, different sense electrode of a second lead. In some examples, one or more of the reference or sense electrodes may reside on a housing or “can” of IMD 16, rather than on a lead. In some examples, IMD 16 includes processing circuitry configured to record the sensed electrical signals from the first plurality of electrode combinations, provide representations of the recorded sensed electrical signals, receive an indication, from a clinician, of two or more
Docket No.: A0010290WO01/1123-801WO01 selected electrodes, and control delivery of electrical stimulation via the two or more selected electrodes. [0063] These sensed electrical signals for the particular patient from combinations of electrodes 24 and/or electrodes 26 may be represented on a display or user interface (not shown in FIG.1) at programmer 14, and/or another computing device. A clinician may select an electrode combination to be used as stimulation electrodes to provide stimulation therapy based on sensed signals from a plurality of different electrode combinations. For instance, a clinician may select an electrode combination including a combination of one or more of electrodes 24 and an electrode on IMD 16 (e.g., a case electrode or can electrode), a combination of one or more of electrodes 26 and an electrode on IMD 16, a combination of two or more of electrodes 24, a combination of two or more of electrodes 26, or a combination of one or more of electrodes 24 and one or more of electrodes 26 to be used as stimulation electrodes. [0064] IMD 16 may be configured to deliver electrical stimulation to the particular patient via the clinician selected electrode combination. As one example, where a clinician selects the electrode combination, the clinician may select the therapy to deliver electrical stimulation to the particular patient via the selected electrode combination. As yet another example, the clinician may input the selected electrode combination to programmer 14 such that programmer 14 automatically selects a therapy and configures IMD 16 to deliver electrical stimulation to the particular patient via the selected electrode combination. As yet another example, the clinician may use a computing device to select an electrode combination that may be communicated to programmer 14 that may configure IMD 16 to deliver electrical stimulation to the particular patient via the clinician-selected electrode combination. [0065] When programing therapy programs 74 for IMD 16 via programmer 14, a clinician may utilize the sensed electrical signals to select the stimulation electrodes to be used for a given therapy program. In order to facilitate the selection of the stimulation electrodes based on the sensed electrical signals, it may be desirable to provide an indication of signal quality, such as a representation of a level of recommendation (e.g., a recommendation rating), for one or more of the electrodes that could possibly be used as stimulation electrodes on a same programming screen through which the clinician may select
Docket No.: A0010290WO01/1123-801WO01 the electrodes that are to be the stimulation electrodes for a given therapy program. These levels of recommendation may be based on the sensed electrical signals. By providing an indication of signal quality, such as a representation of a recommendation rating, for one or more of the electrodes on a same screen from which a clinician may select electrodes to be stimulation electrodes, the techniques of this disclosure may reduce a likelihood that a clinician will make an error in selecting stimulation electrodes, reduce the cognitive load on the clinician, reduce a need for the clinician to take notes when navigating between screens including sensed electrical signals and a programming screen, and/or provide improved patient outcomes as any therapy programs may be more likely to be efficacious due to the improved ease and ability for a clinician to properly select the stimulation electrodes. [0066] According to the techniques of this disclosure, programmer 14 may generate, for presentation via a user interface, a first screen presenting an indication of signal quality based on received signal information for at least one of the plurality of electrodes. Programmer 14 may obtain, via the first screen of the user interface, a selection of one or more of the at least one of the plurality of electrodes as stimulation electrodes. Programmer 14 may program, via telemetry circuitry, IMD 16 to provide electrical stimulation according to a stimulation program, the stimulation program defining the stimulation electrodes. [0067] FIG.2 is functional block diagram illustrating components of an example IMD 16. In the example shown in FIG.2, IMD 16 includes processing circuitry 60, memory 62, stimulation generator 64, sensing circuitry 66, interface 68, telemetry circuitry 70, and power source 72. Memory 62, as well as other memories described herein, may include any volatile or non-volatile media, such as a random-access memory (RAM), read only memory (ROM), non-volatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), flash memory, and the like. Memory 62 may store computer-readable instructions that, when executed by processing circuitry 60, cause IMD 16 to perform various functions described herein. [0068] In the example shown in FIG.2, memory 62 may store therapy programs 74, operating instructions 76, and electrode selection algorithm 78, e.g., in separate memories within memory 62 or separate areas within memory 62. Each stored therapy program 74 defines a particular program of therapy in terms of respective values for electrical stimulation parameters, such as an electrode combination to be used as stimulation electrodes, current or
Docket No.: A0010290WO01/1123-801WO01 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., frequency) of a stimulation signal. Each stored therapy program 74 may also be referred to as a set of stimulation parameter values. Operating instructions 76 guide general operation of IMD 16 under control of processing circuitry 60 and may include instructions for monitoring brain signals within one or more brain regions via electrodes 24, 26 and delivering electrical stimulation therapy to patient 12. As discussed in further detail below and in accordance with one or more techniques of this disclosure, in some examples, memory 62 may store electrode selection algorithm 78, that may include instructions that are executable by processing circuitry 60 to select two or more electrodes to sense electrical stimulation. For instance, electrode selection algorithm 78 may be executable by processing circuitry 60 to select one or more electrode combinations of electrodes 24 and/or electrodes 26 to sense physiological signals and/or deliver electrical stimulation. In some examples, electrode selection algorithm 78 may be executable by processing circuitry 60 to determine an indication of signal quality, such as a recommendation ratings, for one or more electrode combinations of electrodes 24 and/or electrodes 26 to deliver electrical stimulation based on the sensed electrical signals. In some examples, electrode selection algorithm 78 may be executable by processing circuitry 60 to select one or more electrode combinations of electrodes 24 and/or electrodes 26 to deliver electrical stimulation based on input from a user, such as a clinician. [0069] 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, 26. In some examples, stimulation generator 64 generates and delivers stimulation signals to one or more target regions of brain 28 (FIG.1), via a selected electrode combination of stimulation electrodes from electrodes 24, 26, based on one or more stored therapy programs 74. In some examples, therapy programs 74 are chosen at programmer 14 and/or an external computer and transferred to IMD 16 and stored in memory 62. The target tissue sites within brain 28 for stimulation signals or other types of therapy and stimulation parameter values may depend on the patient condition for which therapy system 10 is implemented to manage. While stimulation pulses are described, stimulation signals may be of any form, such as continuous-time signals (e.g., sine waves) or the like.
Docket No.: A0010290WO01/1123-801WO01 [0070] The processor(s) or processing circuitry described in this disclosure, including processing circuitry 60, may include one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry, or combinations thereof. The functions attributed to processors described herein may be provided by a hardware device and embodied as software, firmware, hardware, or any combination thereof. Processing circuitry 60 is configured to control stimulation generator 64 according to therapy programs 74 stored by memory 62 to apply particular stimulation parameter values specified by one or more programs, such as amplitude, pulse width, and pulse rate. [0071] In the example shown in FIG.2, the set of electrodes 24 of lead 20A includes electrodes 24A–24D, and the set of electrodes 26 of lead 20B includes electrodes 26A–26D. Processing circuitry 60 may interface 68 to apply the stimulation signals generated by stimulation generator 64 to a selected electrode combination of stimulation electrodes from electrodes 24 and/or electrodes 26. In some examples, interface 68 may include individual voltage or current sources and sinks coupled to each electrode (i.e., a separate voltage and/or current source and sink for each of electrodes 24 and/or electrodes 26). In some examples, interface 68 may include switch circuitry that may couple stimulation signals to selected conductors within leads 20, that, in turn, deliver the stimulation signals across selected electrodes 24 and/or electrodes 26. In the example where interface 68 includes switch circuitry, the switch circuitry may be a switch array, switch matrix, multiplexer, or any other type of switching circuitry configured to selectively couple stimulation energy to selected electrodes 24 and/or electrodes 26 and to selectively sense bioelectrical brain signals with selected electrodes 24 and/or electrodes 26. In some examples, switch circuitry may be used to couple sensing electrodes of electrodes 24 and/or 26 to sensing circuitry 66, but not to couple stimulation electrodes of electrodes 24 and/or 26 to stimulation generator 64. Hence, stimulation generator 64 is coupled to electrodes 24 and/or electrodes 26 via interface 68 and conductors within leads 20. [0072] As discussed above, processing circuitry 60 may control interface 68 to apply the stimulation signals generated by stimulation generator 64, or sense electrical signals by sensing circuitry 66, to a selected electrode combination of electrodes 24 and/or electrodes
Docket No.: A0010290WO01/1123-801WO01 26. In some examples, the selected electrode combination may be monopolar. For example, one or more electrodes (e.g., one or more cathodes) may be located on lead 20A and the other electrode (e.g., an anode) may be located on lead 20B and the spacing between sensing electrodes may be greater than 30 mm from the spatial extent of the signal source (e.g., 3 – 9 mm). In some examples, the selected electrode combination of electrodes 24 and/or electrodes 26 may be unipolar. For instance, a unipolar selected combination may include one electrode of either electrodes 24 or electrodes 26 in combination with an electrode on the housing of IMD 16 (i.e., case or can), where one is an anode and the other is a cathode. In some examples, the selected electrode combination of electrodes 24 and/or electrodes 26 may be bipolar. As one example, a bipolar selected combination may include two electrodes from electrodes 24, where one is an anode and the other is a cathode. As another example, a bipolar selected combination may include two electrodes from electrodes 26, where one is an anode and the other is a cathode. As another example, a bipolar selected combination may include an electrode from electrodes 24 and an electrode from electrodes 26, where one is an anode and the other is a cathode. In some examples, the selected electrode combination of electrodes 24 and/or electrodes 26 may be multipolar. As one example, a multipolar selected combination may include multiple anodes and/or multiple cathodes selected from electrodes 24. As another example, a multipolar selected combination may include multiple anodes and/or multiple cathodes selected from electrodes 26. As one example, a multipolar selected combination may include multiple anodes and/or multiple cathodes selected from electrodes 24 and electrodes 26. [0073] Stimulation generator 64 may be a single channel or multi-channel stimulation generator. In particular, stimulation generator 64 may be capable of delivering a single stimulation pulse, multiple stimulation pulses or continuous signal at a given time via a single electrode combination or multiple stimulation pulses at a given time via multiple electrode combinations. In some examples, however, stimulation generator 64 and interface 68 may be configured to deliver multiple channels on a time-interleaved basis. For example, interface 68 may serve to time divide the output of stimulation generator 64 across different electrode combinations at different times to deliver multiple programs or channels of stimulation energy to patient 12.
Docket No.: A0010290WO01/1123-801WO01 [0074] Sensing circuitry 66, under the control of processing circuitry 60, is configured to sense bioelectrical brain signals of patient 12 via a selected subset of electrode combinations with one or more electrodes 24 and/or electrodes 26 and at least a portion of a conductive outer housing 34 of IMD 16, an electrode on an outer housing of IMD 16 or another reference. Processing circuitry 60 may control interface 68 to electrically connect sensing circuitry 66 to selected electrodes 24 and/or electrodes 26. In this way, sensing circuitry 66 may selectively sense bioelectrical brain signals with different combinations of electrodes 24 and/or electrodes 26 (and/or a reference other than an electrode of electrodes 24 and/or electrodes 26). [0075] Although sensing circuitry 66 is incorporated into a common housing 34 with stimulation generator 64 and processing circuitry 60 in FIG.2, in other examples, sensing circuitry 66 is in a separate outer housing from outer housing 34 of IMD 16 and communicates with processing circuitry 60 via wired or wireless communication techniques. [0076] Telemetry circuitry 70 is configured to support wireless communication between IMD 16 and a programmer 14 or another computing device under the control of processing circuitry 60. Processing circuitry 60 of IMD 16 may receive a command to execute electrode selection algorithm 78 from programmer 14 and/or therapy programs 74 via telemetry circuitry 70. Therapy programs 74 may include indication(s) of selected stimulation electrodes. Processing circuitry 60 of IMD 16 may also receive, as updates to programs, values for various stimulation parameters such as amplitude and electrode combination for stimulation electrodes, from programmer 14 via telemetry circuitry 70. The updates to the therapy programs may be stored within therapy programs 74 portion of memory 62, as discussed above. Telemetry circuitry 70 in IMD 16, as well as telemetry circuitry in other devices and systems described herein, such as programmer 14, may accomplish communication by RF communication techniques. In addition, telemetry circuitry 70 may communicate with programmer 14 via proximal inductive interaction of IMD 16 with programmer 14. Accordingly, telemetry circuitry 70 may send information to external programmer 14 on a continuous basis, at periodic intervals, or upon request from IMD 16 or programmer 14. [0077] Power source 72 delivers operating power to various components of IMD 16. Power source 72 may include a small rechargeable or non-rechargeable battery and a power
Docket No.: A0010290WO01/1123-801WO01 generation circuit to produce the operating power. Recharging may be accomplished through proximal inductive interaction between an external charger and an inductive charging coil within IMD 16. In some examples, power requirements may be small enough to allow IMD 16 to utilize patient motion and implement a kinetic energy-scavenging device to trickle charge a rechargeable battery. In other examples, traditional batteries may be used for a limited period of time. [0078] FIG.3 is a functional block diagram illustrating components of an example medical device programmer. In the example of FIG.3, programmer 14 includes processing circuitry 80, memory 82, telemetry circuitry 84, user interface 86 with display 83, and power source 88. Processing circuitry 80 controls user interface 86 and telemetry circuitry 84 and stores and retrieves information and instructions to and from memory 82. Programmer 14 may be configured for use as a clinician programmer or a patient programmer. Processing circuitry 80 may comprise any combination of one or more processors including one or more microprocessors, DSPs, ASICs, FPGAs, or other equivalent integrated or discrete logic circuitry. Accordingly, processing circuitry 80 may include any suitable structure, whether in hardware, software, firmware, or any combination thereof, to perform the functions ascribed herein to processing circuitry 80. [0079] A user, such as a clinician or patient 12, may interact with programmer 14 through user interface 86. User interface 86 includes a display 83, such as an LCD or LED display or other type of screen, with which processing circuitry 80 may present information related to the therapy (e.g., electrode combinations) and sensed electrical signals. In addition, user interface 86 may include one or more input device(s) 90, such as input mechanisms to receive input from the user. Input device(s) 90 may include, for example, any one or more of buttons, a keypad (e.g., an alphanumeric keypad), a peripheral pointing device (e.g., a mouse, rollerball, joystick, or the like), a touch screen for display 83, or another input mechanism that allows the user to navigate through screen(s) 89 presented by processing circuitry 80 of programmer 14 and provide input. In other examples, user interface 86 also includes audio circuitry for providing audible notifications, instructions or other sounds to patient 12, receiving voice commands from patient 12, or both. [0080] Memory 82 may include instructions for operating user interface 86 and telemetry circuitry 84, and for managing power source 88. In the example shown in FIG.3, memory
Docket No.: A0010290WO01/1123-801WO01 82 also stores electrode selection algorithm 87. Electrode selection algorithm 87 may be similar to electrode selection algorithm 78 of FIG.2 or may be a corollary to electrode selection algorithm 78 configured to interact with electrode selection algorithm 78 to perform stimulating electrode selection techniques. Electrode selection algorithm 87, that may include instructions that are executable by processing circuitry 80 to command IMD 16 to execute electrode selection algorithm 78 so as to test various electrode combinations as described herein and sense resulting electrical signals. In some examples, processing circuitry 60 of IMD 16 may analyze the sensed electrical signals and determine a respective indication of signal quality, such as a recommendation rating, for the tested electrodes and transmit the sensed electrical signals and the respective indications of signal quality to programmer 14 via telemetry circuitry 70. In some examples, processing circuitry 60 of IMD 16 may transmit the sensed electrical signals to programmer 14 via telemetry circuitry 70 and processing circuitry 80 may determine the respective indications of signal quality. In either case, processing circuitry 60 (e.g., before transmission) and/or processing circuitry 80 (after receipt) may process the sensed electrical signals, such as to remove noise, improve signal to noise ratio, or the like. [0081] In some examples, processing circuitry 80 executing electrode selection algorithm 87 may invoke screen(s) 89 causing processing circuitry 80 to load one or more screens of screen(s) 89 from memory 82 to display 83. For instance, processing circuitry 80 may present electrode selection algorithm 87 may be executable by processing circuitry 80 to select two or more of electrodes and electrode combinations to sense electrical signals in accordance with the techniques described below. [0082] In some examples, screen(s) 89 may include a segments programming screen and a levels programming screen for a given lead. For example, a segments programming screen may depict a respective indication of signal quality (e.g., a respective recommendation rating) for each segmented electrode either of a given level or of all levels, while a levels programming screen may depict a respective indication of signal quality (e.g., a respective recommendation rating) for each level, such as where segmented electrodes are functioning as virtual ring electrodes. [0083] In some examples, processing circuitry 80 may store the sensed electrical signals in results 92. In some examples, processing circuitry 80 may store sensed electrical signals
Docket No.: A0010290WO01/1123-801WO01 from a plurality of different programming sessions over time in results 92. This would permit a clinician to review stored sensed electrical signals over time to monitor or assess disease progression, lead migration, shorts, damaged electrodes, or the like. In some examples, results 92 may alternatively or additionally be stored on a server, such as a web service server or a hospital server. [0084] In some examples, processing circuitry 80 may compare the sensed electrical signals stored over time (e.g., in results 92) to determine a change in sensed electrical signals over time. Processing circuitry 80 may, based on determining the change in the sensed electrical signals, provide notification 94 indicative of the change in the sensed electrical signals. It should be noted that the sensed electrical signals may be processed prior to being saved in results 92 and/or may be saved in their raw form. As such, stored sensed electrical signals may be said to be representations of electrical signals. In some examples, to reduce the number of notifications 94 that may be provided by processing circuitry 80, the providing of notification 94 may be further based on a magnitude of the change in the representations of the electrical signals being greater than or greater than or equal to a threshold. [0085] In some examples, patient 12, a clinician or another user may interact with user interface 86 of programmer 14 in other ways to manually select therapy programs, or combinations of electrodes (e.g., stimulation electrodes), generate new therapy programs, modify therapy programs, transmit the new programs to IMD 16, or any combination thereof. [0086] 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. [0087] 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
Docket No.: A0010290WO01/1123-801WO01 capable of communicating with programmer 14 without needing to establish a secure wireless connection. [0088] Power source 88 is configured to deliver operating power to the components of programmer 14. Power source 88 may include a battery and a power generation circuit to produce the operating power. In some examples, the battery may be rechargeable to allow extended operation. Recharging may be accomplished by electrically coupling power source 88 to a cradle or plug that is connected to an alternating current (AC) outlet. In addition, recharging may be accomplished through proximal inductive interaction between an external charger and an inductive charging coil within programmer 14. In other examples, traditional batteries (e.g., nickel cadmium or lithium ion batteries) may be used. In addition, programmer 14 may be directly coupled to an alternating current outlet to operate. [0089] 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). [0090] 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. [0091] Screen 400 includes a representation of lead 402. Representation of lead 402 includes representations of a plurality of electrodes 404, labeled 0, 1a-1c, 2a-2c, and 3. The representations of the electrodes labeled 1a-1c and 2a-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 1a-1c and 2a- 2c may include segmented electrodes and some of segmented electrodes 1a-1c and 2a-2c may be on a back side of the lead represented by representation of lead 402 and therefore unviewable on representation of lead 402. [0092] Screen 400 also includes a description 410 of the type of therapy program, name and/or ID of the patient for which the therapy program is being generated. Screen 400 also
Docket No.: A0010290WO01/1123-801WO01 may include an interface 412 from which one of a plurality of screens may be selected. For example, screen 400 includes Lead, Annotation, and BrainSense. Annotation 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. BrainSense 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. [0093] Screen 400 also includes a description 420 of which lead (Left STN) 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. [0094] 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. 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. In screen 500 a drop down menu 502 appears. For example, drop down menu 502 may include an Interface to select the viewing of the indications of signal quality, such as levels of recommendation test results (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 which may include details related to sensed signals, a graph of signal power vs. 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. In some examples, if a test has not been conducted, the interface to select the viewing of the levels of recommendation test results may not be operable or displayed. In some examples, if a test has not been conducted, the interface to select the viewing of the levels of recommendation 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 circuitry 80 to send a commend to IMD 16, via telemetry
Docket No.: A0010290WO01/1123-801WO01 circuitry 84, to execute electrode selection algorithm 78 and conduct a test, such as a monopolar sensing test. [0095] FIG.6 is a conceptual diagram illustrating an example user interface results screen displaying a lead including plurality of electrodes and respective levels of recommendations for some of the 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 of FIG.5, processing circuitry 80 may cause display 83 to display screen 600 on display 83. Screen 600 may display levels of recommendation 602 for each of segmented electrodes 1a- 1c and 2a-2c. [0096] 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 levels of recommendation are based. [0097] As can be seen in the example screen 600 of FIG.6, the levels of recommendation may be displayed in a graphical form (shown here as circles). For example, the greater number of circles which may appear filled in, the higher the recommendation may be. In some examples, the levels of recommendation may be represented by color. For example, the circles may be filled in with colors representative of the recommendation rating to further distinguish a higher recommendation rating from a lower recommendation rating. For example, if all three circles are to be filled in to highly recommend segmented electrodes 1a and 1b, these circles may be filled in with a green color to indicate a high recommendation, while the two circles of segmented electrodes 1c, 2a, and 2b may be filled in with a different color to indicate a medium recommendation, and the one circle of segmented electrode 2c may be filled in with yet another color to indicate a low recommendation. In some examples, the entire representation of the segmented electrode may be colored to represent a respective recommendation rating. Different shapes, colors, or numbers of indicators may be used for the electrodes in other examples. [0098] FIG.7 is a conceptual diagram illustrating another example user interface results screen displaying a lead including plurality of electrodes and respective levels of recommendations for some of the electrodes in accordance with one or more aspects of this
Docket No.: A0010290WO01/1123-801WO01 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 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. Levels of recommendation 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. [0099] FIG.8 is a conceptual diagram illustrating the example user interface results screen of FIG.6 include an indication of user inputs in accordance with one or more aspects of this disclosure. Screen 800 may be a screen of screen(s) 89 and include screen 500 with a child window 810 overlaid over screen 500. Processing circuitry 80 may cause display 83 to display screen 800 on display 83. For example, if a user selects “Segments” from screen 700, processing circuitry 80 may cause display 83 to display screen 800 on display 83 which breaks out each segmented electrode for each axial level of the lead. On screen 800 (which may be the same or similar as screen 600), a user may select as stimulation electrodes all of segmented electrodes 1a-1c and electrode 0, or some subset of those electrodes. It should be noted that a user may select any combination of electrodes as stimulation electrodes. The levels of recommendation 802 represented in screen 800 may guide the user in selecting which electrodes should be the stimulation electrodes. In this manner, a processing circuitry 80 may present, via user interface 86, a first screen (e.g., screen 800) presenting a representation of a plurality of electrodes and a representation of a respective recommendation rating for at least one of the plurality of electrodes and obtain a selection, via the first screen of the user interface, of one or more of the at least one of the plurality of electrodes as stimulation electrodes. [0100] FIG.9 is a conceptual diagram illustrating the example user interface results screen of FIGS.6 and 8 including a selection of stimulation electrodes via user input in accordance with one or more aspects of this disclosure. Screen 900 may be a screen of screen(s) 89 and include screen 900 with a child window 910 overlaid over screen 900.
Docket No.: A0010290WO01/1123-801WO01 Processing circuitry 80 may cause display 83 to display screen 900 on display 83. For example, when a user selects all of segmented electrodes 1a-1c and electrode 0, processing circuitry 80 may cause display 83 to display screen 900 on display 83. Screen 900 may include an indication 902 indicating which electrodes have been selected to be stimulation electrodes, which may be some or all of the segmented electrodes at the same axial level of the lead. In some examples, the user may select which electrode(s) will function as anodes or cathodes and indication 902 may differ based on whether a particular electrode is to be an anode or cathode. Screen 900 may include a button to cancel the selected electrodes and a button to update or save the selected electrodes as stimulation electrodes. It should be noted that screen 900 may function similar to screens 700 and 800, facilitating a user selecting stimulation electrodes while viewing representations of levels of recommendation 902. [0101] FIG.10 is a conceptual diagram illustrating an example user interface lead screen displaying a lead including selected electrodes as stimulation electrodes and providing an input for other parameters associated with a therapy program 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. For example, when a user selects “Update” on screen 900, processing circuitry 80 may cause display 83 to remove screen 900 and display screen 1000 on display 83. Screen 1000 may include a representation of lead 1002 (which may correspond to representation of lead 402) but may include an indication 1004 of which electrodes have been selected as stimulation electrodes. Indication 1004 may be similar to indication 902. Screen 1000 may include interfaces 1006 to input other parameters of a particular therapy program (e.g., Program 1), such as amplitude, pulse width, and frequency. [0102] FIG.11 is a conceptual diagram illustrating an example screen including power spectral densities in accordance with one or more techniques of this disclosure. For example, if a user selects BrainSense from screen 400, processing circuitry 80 may provide the user with one or more screens (or an interface from which to select one or more screens) such as screen 1310 on display 83. Screen 1310 includes a representation of a lead in box 1300 with the bottom electrode of the lead acting as a reference electrode. Graph 1302 displays the raw power spectral density of sensed electrical signals using monopolar sensing on a segment-by- segment basis. Graph 1304 displays the raw power spectral density of the sensed electrical
Docket No.: A0010290WO01/1123-801WO01 signals by the ring electrodes and any segmented electrodes in ring mode using monopolar sensing. Graph 1306 displays noise reduced power spectral density of the sensed electrical signals using monopolar sensing on a segment-by-segment basis. Graph 1308 displays noise reduced power spectral density of the sensed electrical signals (e.g., processed sensed electrical signals) by the ring electrodes and any segmented electrodes in ring mode using monopolar sensing. As can be seen, screen 1310 includes a lot of information. A similar screen may exist for each potential reference electrode. As such, the sheer volume of information relating to the sensed electrical signals may make it difficult for a clinician to, based on the information in screen 1310 and each of the other similar screens, select electrodes as stimulation electrodes without error or without taking extensive notes if there were no presentation of indications of signal quality, such as levels of recommendation, on a same screen as the screen used to select the electrodes as stimulation electrodes (e.g., screens 600, 700, 800 or 900 of FIGS.6-9). In cases which include many electrodes and/or segmented electrodes, it may be impossible for a clinician to analyze all the screens containing information such as that of screen 1310, retain the information within these screens and/or the results of the analysis in their mind as they navigate to a screen to select electrodes as stimulation electrodes. As such, it may be desirable to provide screens such as screens 600, 700, 800, and 900, which include indications of signal quality, such as levels of recommendation, and permit a clinician to select electrodes as stimulation electrodes from a same screen. [0103] FIG.12 is a flow diagram of an example technique for selecting an electrode combination to deliver electrical stimulation, in accordance with one or more techniques of this disclosure. While described primarily with respect to processing circuitry 80 of FIG.3, it should be noted that the techniques of FIG.12 may be practiced by processing circuitry of any device or combination of devices capable of performing such techniques. [0104] Processing circuitry 80 may generate, for presentation via a user interface, a first screen presenting a representation of a plurality of electrodes and an indication of signal quality based on received signal information for at least one of the plurality of electrodes (1200). For example, processing circuitry 80 may determine a respective recommendation rating for any of electrodes 24 or 26 (FIG.1). Processing circuitry 80 may generate screen
Docket No.: A0010290WO01/1123-801WO01 600, 700, 800, or 900. Screen 600, 700, 800, or 900 may include a representation of respective recommendation rating (e.g., levels of recommendation 602, 702, 802, 902). [0105] Processing circuitry 80 may obtain, via the first screen of the user interface, a selection of one or more of the at least one of the plurality of electrodes as stimulation electrodes (1202). For example, a clinician may select, via screen 600, 700, 800, or 900, one or more electrodes of electrodes 24 or 26 as stimulation electrodes. Processing circuitry 80 may obtain the clinician selection. Obtaining the selection via the first screen is intended to include obtaining the selection from interactions of the clinician with the first screen through any of input device(s) 90 and not just interactions through a touch screen. [0106] Processing circuitry 80 may program, via the telemetry circuitry, an IMD to provide electrical stimulation according to a stimulation program, the stimulation program defining the stimulation electrodes (1204). For example, processing circuitry 80 may transmit a therapy program of therapy programs 74 to IMD 16 via telemetry circuitry 84. The therapy program may include the identification of the stimulation electrodes. [0107] In some examples, the plurality of electrodes (e.g., electrodes 24 and/or 26) include at least one segmented electrode that is disposed at a partial perimeter around a lead. In some examples, the indication of signal quality includes a respective recommendation rating for the at least one segmented electrode. In some examples, the indication of signal quality includes a recommendation rating for a ring electrode or a virtual ring electrode comprising a plurality of segmented electrodes disposed at a same axial position on a lead. [0108] In some examples, the indication of signal quality (e.g., representation of the respective level of recommendation 602, 702, 802, or 902) includes at least one of a color or a graphical representation. In some examples, user interface 86 further includes an interface (e.g., interface 412 or drop down menu 502) operable for a user to provide an indication to perform a test on the implantable medical device. In such examples, processing circuitry 80 is further configured to: obtain, from the user, the indication to perform the test; and obtain, via telemetry circuitry 84, results 92 of the test. In some examples, processing circuitry 80 is configured to execute the test to control IMD 16 to sense electrical signals from a plurality of electrode combinations, each of the plurality of electrode combinations including a same reference electrode of a plurality of electrodes and at least one different sense electrode of the plurality of electrodes. In some examples, the electrical signals include monopolar local field
Docket No.: A0010290WO01/1123-801WO01 potentials (LFPs). In some examples, results 92 of the test include representations of the electrical signals (e.g., of graphs 1302, 1304, 1306, and 1308), and processing circuitry 80 is further configured to generate the indication of signal quality based on the representations of the electrical signals. In some examples, the indication of signal quality is based on signal strength of one or more of the electrical signals. In some examples, user interface 86 further includes a screen (e.g., screen 1310) including the representations of the electrical signals. [0109] In some examples, user interface 86 further includes a representation of at least one of an amplitude, a pulse width, or a frequency associated with the stimulation program (e.g., interface 1006), and processing circuitry 86 is further configured to obtain at the least one of the amplitude, the pulse width, or the frequency associated with the stimulation program from the user via user interface 86. In some examples, processing circuitry 80 is further configured to store the representations of the electrical signals in the memory (e.g., in results 92). In some examples, processing circuitry 80 is further configured to present, via user interface 86, a plurality of the representations of the electrical signals (e.g., results 92) stored over time. In some examples, processing circuitry 80 is further configured to determine a change in the representations of the electrical signals over time, and based on determining the change in the representations of the electrical signals, control user interface 86 to present notification 94 indicative of the change in the representations of the electrical signals. In some examples, providing the notification 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. [0110] In some examples, system 10 and/or programmer 14 includes display 83. In some examples, system 10 includes IMD 16. In some examples, IMD 16 includes stimulation generator 64 and wherein IMD 16 provides the electrical stimulation according to the stimulation program (e.g., of therapy programs 74) via stimulation generator 64 and the stimulation electrodes. [0111] As described herein, a system that employs directional brain sensing may reduce the time required to identify electrode combinations for sensing desired signals and/or delivering electrical stimulation therapy. In this manner, the systems described herein may improve clinician efficiency and treatment efficacy. Moreover, by providing representations of indications of signal quality, such as respective levels of recommendation, for electrodes
Docket No.: A0010290WO01/1123-801WO01 on a same screen by which a clinician may select electrodes to be used as stimulation electrodes, the systems and techniques described herein may reduce a likelihood a clinician may make an error in programming, reduce the need for the clinician to take notes during a testing and programming session, reduce a cognitive load on the clinician in trying to remember a multitude of results while navigating to a programming screen, and/or reduce an amount of time required to program therapy. These techniques are indeed advantageous considering the use of increasing numbers of electrodes on implantable leads (e.g., leads with electrodes disposed at different positions around the perimeter of the lead and at different positions along the length of the lead). Therefore, the techniques and systems described herein may further enable the use of more electrodes that may improve targeting of desired tissue (e.g., specific regions of the brain associated with a disease, symptoms, or therapy) while reducing the time necessary for programming by the clinician. The techniques and systems described herein may also further enable the use of different electrode configurations and geometries. [0112] The techniques described in this disclosure, including those attributed to IMD 16, programmer 14, or various constituent components, may be implemented, at least in part, in hardware, software, firmware or any combination thereof. For example, various aspects of the techniques may be implemented within one or more processors, including one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components, embodied in programmers, such as clinician or patient programmers, medical devices, or other devices. [0113] In one or more examples, the functions described in this disclosure may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored, as one or more instructions or code, on a computer- readable medium and executed by a hardware-based processing unit. Computer-readable media may include computer-readable storage media forming a tangible, non-transitory medium. Instructions may be executed by one or more processors, such as one or more DSPs, ASICs, FPGAs, general purpose microprocessors, or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor,” as used herein may refer to one or more of any of the foregoing structures or any other structure suitable for implementation of the techniques described herein.
Docket No.: A0010290WO01/1123-801WO01 [0114] In addition, in some respects, the functionality described herein may be provided within dedicated hardware and/or software modules. Depiction of different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be realized by separate hardware or software components. Rather, functionality associated with one or more modules or units may be performed by separate hardware or software components or integrated within common or separate hardware or software components. Also, the techniques may be fully implemented in one or more circuits or logic elements. The techniques of this disclosure may be implemented in a wide variety of devices or apparatuses, including an IMD, an external programmer, a combination of an IMD and external programmer, an integrated circuit (IC) or a set of ICs, and/or discrete electrical circuitry, residing in an IMD and/or external programmer. [0115] This disclosure includes the following non-limiting examples. [0116] Example 1. A medical device system comprising: a memory configured to store a user interface; telemetry circuitry; and processing circuitry coupled to the memory and the telemetry circuitry, the processing circuitry being configured to: generate, for presentation via the user interface, a first screen presenting a representation of a plurality of electrodes and an indication of signal quality based on received signal information for at least one of the plurality of electrodes; obtain, via the first screen of the user interface, a selection of one or more of the at least one of the plurality of electrodes as stimulating electrodes; and program, via the telemetry circuitry, an implantable medical device (IMD) to provide electrical stimulation according to a stimulation program, the stimulation program defining the stimulation electrodes. [0117] Example 2. The medical device system of example 1, wherein the plurality of electrodes comprise at least one segmented electrode that is disposed at a partial perimeter around a lead. [0118] Example 3. The medical device system of example 2, wherein the indication of signal quality comprises a respective recommendation rating for the at least one segmented electrode. [0119] Example 4. The medical device system of example 2, wherein the indication of signal quality comprises a recommendation rating for a ring electrode or a
Docket No.: A0010290WO01/1123-801WO01 virtual ring electrode comprising a plurality of segmented electrodes disposed at a same axial position on a lead. [0120] Example 5. The medical device system of any of examples 1-4, wherein indication of signal quality comprises at least one of a color or a graphical representation. [0121] Example 6. The medical device system of any of examples 1-5, wherein the user interface further comprises an interface operable for a user to provide an indication to perform a test on the implantable medical device and wherein the processing circuitry is further configured to: obtain, from the user, the indication to perform the test; and obtain, via the telemetry circuitry, results of the test. [0122] Example 7. The medical device system of example 6, wherein processing circuitry is configured to execute the test to control the IMD to sense electrical signals from a plurality of electrode combinations, each of the plurality of electrode combinations comprising a same reference electrode of a plurality of electrodes and at least one different sense electrode of the plurality of electrodes. [0123] Example 8. The medical device system of example 7, wherein the electrical signals comprise local field potentials (LFPs). [0124] Example 9. The medical device system of example 7 or example 8, wherein the results of the test comprise representations of the electrical signals, and wherein the processing circuitry is further configured to generate the indication of signal quality based on the representations of the electrical signals. [0125] Example 10. The medical device system of example 9, wherein the indication of signal quality is based on signal strength of one or more of the electrical signals. [0126] Example 11. The medical device system of example 9 or example 10, wherein the user interface further comprises a screen comprising the representations of the electrical signals. [0127] Example 12. The medical device system of any of examples 1-11, wherein the user interface further comprises a representation of at least one of an amplitude, a pulse width, or a frequency associated with the stimulation program, and wherein the processing circuitry is further configured to obtain at the least one of the amplitude, the pulse width, or the frequency associated with the stimulation program from the user via the user interface.
Claims
Docket No.: A0010290WO01/1123-801WO01 [0128] Example 13. The medical device system of any of examples 1-12, wherein the processing circuitry is further configured to store the representations of the electrical signals in the memory. [0129] Example 14. The medical device system of example 13, wherein the processing circuitry is further configured to present, via the user interface, a plurality of the representations of the electrical signals stored over time. [0130] Example 15. The medical device system of example 14, wherein the processing circuitry is further configured to: determine a change in the representations of the electrical signals over time; and based on determining the change in the representations of the electrical signals, control the user interface to present a notification indicative of the change in the representations of the electrical signals. [0131] Example 16. The medical device system of any of examples 1-15, further comprising the display. [0132] Example 17. The medical device system of any of examples 1-16, further comprising the IMD. [0133] Example 18. The medical device system of any of examples 1-17, wherein the IMD comprises stimulation circuitry and wherein the IMD provides the electrical stimulation according to the stimulation program via the stimulation circuitry and the stimulation electrodes. [0134] Example 19. A method comprising: generating, for presentation via a user interface, a first screen presenting a representation of a plurality of electrodes and an indication of signal quality based on received signal information for at least one of the plurality of electrodes; obtaining, via the first screen of the user interface, a selection of one or more of the at least one of the plurality of electrodes as stimulating electrodes; and programing, via telemetry circuitry, an implantable medical device (IMD) to provide electrical stimulation according to a stimulation program, the stimulation program defining the stimulation electrodes. [0135] Example 20. The method of example 19, wherein the plurality of electrodes comprise at least one segmented electrode that is disposed at a partial perimeter around a lead.
Docket No.: A0010290WO01/1123-801WO01 [0136] Example 21. The method of example 20, wherein the indication of signal quality comprises a respective recommendation rating for the at least one segmented electrode. [0137] Example 22. The method of example 19, wherein the indication of signal quality comprises a recommendation rating for a ring electrode or a virtual ring electrode comprising a plurality of segmented electrodes disposed at a same axial position on a lead. [0138] Example 23. The method of any of examples 19-22, wherein indication of signal quality comprises at least one of a color or a graphical representation. [0139] Example 24. A non-transitory computer-readable storage medium storing instructions that, when executed, cause processing circuitry to: generate, for presentation via a user interface, a first screen presenting a representation of a plurality of electrodes and an indication of signal quality based on received signal information for at least one of the plurality of electrodes; obtain, via the first screen of the user interface, a selection of one or more of the at least one of the plurality of electrodes as stimulating electrodes; and program, via telemetry circuitry, an implantable medical device (IMD) to provide electrical stimulation according to a stimulation program, the stimulation program defining the stimulation electrodes. [0140] Various examples of the disclosure have been described. These and other examples are within the scope of the following claims.
Docket No.: A0010290WO01/1123-801WO01 12. The medical device system of any of claims 1-11, wherein the processing circuitry is further configured to: store the representations of the electrical signals in the memory; and present, via the user interface, a plurality of the representations of the electrical signals stored over time. 13. The medical device system of claim 12, wherein the processing circuitry is further configured to: determine a change in the representations of the electrical signals over time; and based on determining the change in the representations of the electrical signals, control the user interface to present a notification indicative of the change in the representations of the electrical signals. 14. A method comprising: generating, for presentation via a user interface, a first screen presenting a representation of a plurality of electrodes and an indication of signal quality based on received signal information for at least one of the plurality of electrodes; obtaining, via the first screen of the user interface, a selection of one or more of the at least one of the plurality of electrodes as stimulating electrodes; and programing, via telemetry circuitry, an implantable medical device (IMD) to provide electrical stimulation according to a stimulation program, the stimulation program defining the stimulation electrodes. 44
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