WO2014143709A1 - Visualisation d'électrodes de fil de stimulation pertinentes par rapport à des informations de stimulation sélectionnées - Google Patents

Visualisation d'électrodes de fil de stimulation pertinentes par rapport à des informations de stimulation sélectionnées Download PDF

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Publication number
WO2014143709A1
WO2014143709A1 PCT/US2014/027782 US2014027782W WO2014143709A1 WO 2014143709 A1 WO2014143709 A1 WO 2014143709A1 US 2014027782 W US2014027782 W US 2014027782W WO 2014143709 A1 WO2014143709 A1 WO 2014143709A1
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Prior art keywords
leadwire
stimulation
electrodes
region
graphical
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PCT/US2014/027782
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English (en)
Inventor
Michael A. Moffitt
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Boston Scientific Neuromodulation Corporation
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Priority claimed from US14/011,836 external-priority patent/US9227074B2/en
Application filed by Boston Scientific Neuromodulation Corporation filed Critical Boston Scientific Neuromodulation Corporation
Publication of WO2014143709A1 publication Critical patent/WO2014143709A1/fr

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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

Definitions

  • the present invention relates to a system and method for generating and outputting therapeutic stimulation-related information in relation to electrodes of an implanted leadwire usable for electrically stimulating an anatomical region. Such output can be provided on a patient-specific basis and/or on an implant-position basis.
  • the leadwire can be, e.g., of a Deep Brain Stimulation (DBS) device or a Spinal Cord Stimulation (SCS) device.
  • DBS Deep Brain Stimulation
  • SCS Spinal Cord Stimulation
  • DBS deep brain stimulation
  • SCS spinal cord stimulation
  • Occipital NS therapy Trigemenal NS therapy
  • Vagus NS therapy peripheral field stimulation therapy
  • sacral root stimulation therapy or other such therapies.
  • DBS can include stimulation of the thalamus or basal ganglia and may be used to treat disorders such as essential tremor, Parkinson's disease (PD), and other physiological disorders, including psychiatric disorders.
  • PD Parkinson's disease
  • DBS can also be useful for traumatic brain injury and stroke. Pilot studies have also begun to examine the utility of DBS for treating dystonia, epilepsy, and obsessive-compulsive disorder.
  • the stimulation parameters, electrode geometries, or electrode locations that are best suited for existing or future uses of DBS also are unclear.
  • a neurosurgeon can select a target region within the patient anatomy, e.g., within the brain for DBS, an entry point, e.g., on the patient's skull, and a desired trajectory between the entry point and the target region.
  • the entry point and trajectory are typically carefully selected to avoid intersecting or otherwise damaging certain nearby critical structures or vasculature.
  • a stimulation electrode leadwire used to provide the stimulation to the relevant anatomical region is inserted along the trajectory from the entry point toward the target region.
  • the stimulation electrode leadwire typically includes multiple closely-spaced electrically independent stimulation electrode contacts.
  • the target anatomical region can include tissue that exhibit high electrical conductivity.
  • a stimulation parameter can include a current amplitude or voltage amplitude, which can be the same for all of the electrodes of the leadwire, or which can vary between different electrodes of the leadwire.
  • the applied amplitude setting results in a corresponding current in the surrounding fibers, and therefore a corresponding voltage distribution in the surrounding tissue.
  • the complexity of the inhomogeneous and anisotropic fibers makes it difficult to predict the particular volume of tissue influenced by the applied stimulation.
  • a treating physician typically would like to tailor the stimulation parameters (such as which one or more of the stimulating electrode contacts to use, the stimulation pulse amplitude, e.g., current or voltage depending on the stimulator being used, the stimulation pulse width, and/or the stimulation frequency) for a particular patient to improve the effectiveness of the therapy.
  • Parameter selections for the stimulation can be achieved via tedious and variable trial-and-error, without visual aids of the electrode location in the tissue medium or computational models of the volume of tissue influenced by the stimulation. Such a method of parameter selection is difficult and time-consuming and, therefore, expensive. Moreover, it may not necessarily result in the best possible therapy.
  • the leadwire can include cylindrically symmetrical electrodes, which, when operational, produce approximately the same electric values in all positions at a similar distance from the electrode in any plane that cuts through the electrode.
  • the leadwire can include directional electrodes that produce different electrical values depending on the direction from the electrode.
  • the leadwire can include multiple separately controllable electrodes arranged cylindrically about the leadwire at each of a plurality of levels of the leadwire. Each electrode may be set as an anode or cathode in a bipolar configuration or as a cathode, with, for example, the stimulator casing being used as ground, in a monopolar arrangement.
  • a leadwire for tissue stimulation e.g., DBS
  • the clinical standard of care is often to perform a monopolar review (MPR) upon activation of the leadwire in order to determine the efficacy and side-effect thresholds for all electrodes on the leadwire, on an electrode-by-electrode basis.
  • MPR monopolar review
  • the MPR can inform the selection of a first clinical program (parameters for stimulation) for treating a patient.
  • Example systems for programming a leadwire for tissue stimulation display a graphical representation of an area within which it is estimated that there is or could be tissue activation, referred to herein as a volume of activation (VOA), that results from input stimulation parameters.
  • VOA volume of activation
  • the VOA can be calculated as a region outside of which stimulation is estimated to be unlikely.
  • the VOA can be displayed relative to an image or model of a portion of the patient's anatomy.
  • VOA may be based on Neural Element Models such as a model of fibers, e.g., axons, and a voltage distribution about the leadwire and on detailed processing thereof. Performing such processing to provide a VOA preview in real-time response to a clinician's input of parameters is not practical because of the significant required processing time. Therefore, conventional systems pre-process various stimulation parameter settings to determine which axons are activated by the respective settings.
  • Those systems also provide interfaces via which to input selections of the stimulation parameters and notes concerning therapeutic and/or side effects of stimulations associated with graphically represented VOAs.
  • the systems also allow user input of, or automatically determine, a target stimulation region, e.g., within or encompassing one or more defined anatomic structures, or allow user input of, or automatically determine, a target defined anatomic structure, which target region or structure is targeted for stimulation.
  • Example embodiments of the present invention provide a system and method that generates a map including a representation of stimulation leadwire electrodes and graphical markings visually indicating most significant ones of the electrodes with respect to particular stimulation-related information.
  • the stimulation-related information represents an anatomic structure, e.g., the sub-thalamic nucleus (STN), targeted for stimulation.
  • the stimulation-related information represents an anatomic region targeted for stimulation.
  • the stimulation-related information represents regions that, when stimulated, are estimated to result in therapeutic success to achieve a good clinical effect, and/or a gradient in degree of such success.
  • the stimulation-related information represents regions that, when stimulated, are estimated to result in an adverse side effect, and/or a gradient in degree of such adverse side effects.
  • the system and method generates the map based on a combination of two or more of the above-indicated types of stimulation-related information.
  • the map includes a marking visually indicating a range of most significant electrodes and a further marking indicating the single most significant one of the electrodes with respect to the relevant stimulation-related information.
  • the respective degrees of significance of different ones of the electrodes with respect to the relevant stimulation-related information, determined for the purpose of generating the map is based on the respective proximities of the electrodes to an anatomic region associated with the stimulation-related information.
  • proximity is determined based on the length of a ray that is perpendicular to the longitudinal axis of the leadwire and extends from the electrode to the associated anatomic region.
  • the marking(s) provided in the generated map are provided in a grid formed by a first axis representing the different electrodes and a second axis representing a range of values of a selected stimulation parameter, e.g., stimulation amplitude.
  • the system records data pertaining to stimulations associated with particular values of the selected stimulation parameter using particular ones of the electrodes. Such data can include, for example, a therapeutic effect and/or adverse side effect determined or indicated to have occurred or estimated to occur, e.g., using particular ones of the values of the selected stimulation parameter at particular ones of the electrodes.
  • the system plots graphical markings corresponding to respective ones of such recorded data at the electrode/stimulation value pair for which the respective datum had been recorded.
  • the marking(s) indicating which of the electrodes are significant with respect to the stimulation-significant anatomic region are provided within the grid that includes the markings representing the recorded data, thereby providing an indication of the relationship of those electrodes which are or can be assumed to be significant with respect to the stimulation-significant anatomic region to the recorded data.
  • the grid includes plotted therein a graphical marking representing a recorded occurrence of an adverse side effect of a stimulation centered at one of the electrodes at a particular stimulation amplitude.
  • the marking is placed in the grid at the location corresponding to the electrode at which the stimulation was centered and corresponding to the amplitude of the stimulation.
  • the grid also includes therein a marking showing which one or more of the electrodes correspond to a target stimulation region or structure, which therefore provides a visual indication of which one or more electrodes are most likely best able to be used for stimulating the target region or structure and how stimulation using those one or more electrodes might cause an adverse side effect.
  • the markings can help the user determine the electrode at which to center stimulation and the amplitude settings to avoid. Similarly, if the grid instead plots the markings representing the adverse side effects against a different stimulation setting, the grid would give the user an idea of which values to use or avoid for such other stimulation setting.
  • the system and method provides in a graphical user interface an input component with which the user can select the stimulation parameter to be represented in the grid.
  • the user can switch between different parameter types and, based on the plots of the markings in the different grids corresponding to the different parameter types, tailor stimulation settings.
  • the number of markings representing the side effects in the grid depends on the number of side effects that have been recorded, the severity of the recorded side effects, and/or filter criteria by which to filter which side effects to display.
  • filter criteria can include age, sex, and/or condition of the patient whose stimulation resulted in the recorded side effect; severity of the side effect; and/or number of instances of the side effect at the particular stimulation location and stimulation parameter value, etc.
  • the markings representing the side effects are displayed to indicate the severity or, and/or the number, of the recorded adverse side effects corresponding to the grid position.
  • a number or making size can be used to represent the number of recorded side effects, or a number or marking size can be used to represent the severity of the recorded side effects (e.g., an average of all recorded side effects corresponding to the grid location).
  • a size can be used to indicate severity and a number can be used to indicate the number of recorded side effects.
  • the number can be the marking, and its size can vary depending on severity.
  • Other indicia can be used instead or in addition. For example, degrees of transparency or different colors can be used to represent different severities or numbers.
  • the markings can represent adverse side effects or therapeutic effect, number and severity being indicated according to an example embodiment regardless of which is represented. In an example embodiment, makings can be included for both therapeutic effect and side effect.
  • the markings can be differently output depending on whether they represent therapeutic effect or adverse side effect. For example, different colors and/or shapes can be used depending on whether a marking represents a therapeutic effect or a side effect.
  • the effect markings are selectable, in response to which selection additional details are provided regarding the corresponding therapeutic effects and/or adverse side effects.
  • the '330, '312, '340, '343, and '314 applications describe notes entered by a user using a graphical user interface components.
  • the system in response to selection of a marking in the grid, which marking represents a therapeutic or adverse side effect, the system outputs, e.g., displays in a graphical user interface, such a note previously input in association with the effect, or outputs a further interface component by which such a note is selectable for viewing.
  • information on which basis the markings representing the therapeutic and/or side effects are based are obtained automatically using sensors and/or by user input, for example, as described in any of the '330, '312, '340, '343, '314, '866, and ⁇ 35 applications.
  • the markings visually indicating most significant ones of the electrodes with respect to particular stimulation-related information such as a target region, and/or the markings representing recorded information associated with stimulations centered at one or more of the electrodes at particular stimulation parameter settings, as described above are displayed in a graphical user interface display including a plurality of tabs and are displayed in association with a first one of the plurality of tabs, where others of the tabs are selectable for display of other stimulation- related information.
  • one of the other tabs is selectable for display, in response to its selection, of volume of activation (VOA) information, for example, as described in the '330, '312, '340, '343, '314, ' 1 15, and '232 applications.
  • VOA volume of activation
  • the other tab is selectable for display of a representation of the target region for which the first tab indicates the electrodes most likely to be relevant, the target region being displayed relative to a displayed representation of anatomic regions of a patient.
  • Such a representation of the target region can be in a two- dimensional format or a three-dimensional format.
  • the other tab is selectable for display of a volume representing gradations in therapeutic and/or adverse side effects relative to anatomic regions of a patient.
  • a representation can be in a two-dimensional format or a three-dimensional format.
  • one of the other tabs is selectable for display of the target region relative to anatomic structures and another of the other tabs is selectable for display of the volume representing the described gradations. The user can accordingly quickly switch between a number of views, each providing different types of information concerning possible stimulations, and accordingly decide on which stimulation parameters to set for the leadwire electrodes to produce a stimulation of tissue in a patient.
  • An example embodiment of the present invention is directed to one or more processors, which can be implemented using any conventional processing circuit and device or combination thereof, e.g., a Central Processing Unit (CPU) of a Personal Computer (PC) or other workstation processor, to execute code provided, e.g., on a hardware computer- readable medium including any conventional memory device, to perform any of the methods described herein, alone or in combination, and to generate any of the user interface displays described herein, alone or in combination.
  • the one or more processors can be embodied in a server or user terminal or combination thereof.
  • the user terminal can be embodied, for example, as a desktop, laptop, hand-held device, Personal Digital Assistant (PDA), television set-top Internet appliance, mobile telephone, smart phone, etc., or as a combination of one or more thereof.
  • the terminal can be embodied as a clinician programmer terminal, e.g., as referred to in the '330, '312, '340, '343, and '314 applications.
  • some of the described methods can be performed by a processor on one device or terminal and using a first memory, while other methods can be performed by a processor on another device and using, for example, a different memory.
  • the memory device can include any conventional permanent and/or temporary memory circuits or combination thereof, a non-exhaustive list of which includes Random Access Memory (RAM), Read Only Memory (ROM), Compact Disks (CD), Digital Versatile Disk (DVD), and magnetic tape.
  • RAM Random Access Memory
  • ROM Read Only Memory
  • CD Compact Disks
  • DVD Digital Versatile Disk
  • An example embodiment of the present invention is directed to one or more hardware computer-readable media, e.g., as described above, on which are stored instructions executable by a processor to perform the methods and/or provide the user interface features described herein.
  • An example embodiment of the present invention is directed to a method, e.g., of a hardware component or machine, of transmitting instructions executable by a processor to perform the methods and/or provide the user interface features described herein.
  • FIG. 1 shows an example stimulation and programming system according to an example embodiment of the present invention.
  • FIG. 2 shows an example display screen generable by the system, including a marking showing one or more electrodes that are proximal to a stimulation significant region, according to an example embodiment of the present invention.
  • FIG. 3 A illustrates the passing of a leadwire through a stimulation significant region on which basis display screens are generable according to example embodiments of the present invention.
  • FIG. 3B illustrates a region considered to be significant, according to an example embodiment of the present invention, for generating the described display screens, in an instance where the leadwire does not pass through the stimulation significant region.
  • FIG. 4 shows an example display screen including a marking identifying the locationally relevant electrodes and an additional marking identifying the electrode corresponding to a sub-area within the stimulation significant region, according to an example embodiment of the present invention.
  • FIG. 5 shows an example display screen in which variations in therapeutic and/or side effect scores are graphically identified by variations in opacity/transparency, according to an example embodiment of the present invention.
  • FIG. 6 shows an example display screen including a two-dimensional leadwire model and a parameter recommendation marking indicating a recommended value for a predetermined or selected stimulation parameter, according to an example embodiment of the present invention.
  • FIG. 1 shows an example system according to an example embodiment of the present invention.
  • a system 100 includes a clinician programmer terminal 105 that includes a telemetry module 106 and a user interface generation module 107.
  • the telemetry module is in communication with an implanted pulse generator (IPG) 110.
  • IPG implanted pulse generator
  • the user interface generation module 107 includes software executable by a processor for generating graphical user interface displays.
  • interaction with one or more graphical user interface displays and/or a hardware input device is usable for input of one or more stimulation parameter settings in accordance with which the telemetry module 106 outputs instructions to the IPG 1 10, the IPG 110 accordingly controlling a leadwire 120 to activate one or more electrodes 121a-121g to produce electric pulses at specified amplitudes.
  • the leadwire 120 is implanted in a patient, e.g., in the patient's brain, and the electric pulses are intended to activate anatomic fibers to produce a therapeutic effect, e.g., as described in further detail in the '330, '312, '340, '343, and '314 applications.
  • the electrodes 121a-121g can include one or more directional electrodes which can be controlled to direct stimulation in a particular radial direction from the central longitudinal axis of the leadwire 120 and/or can include one or more cylindrical electrodes that produce essentially the same stimulation in all directions rotationally about the cylindrically symmetrical stimulation about the central longitudinal axis of the leadwire 120.
  • FIG. 2 shows an example of a user interactive graphical user interface display screen
  • the example display screen 200 includes a leadwire model 204 that represents a leadwire, e.g., the implanted leadwire 120.
  • the leadwire model 204 includes representations of each of a plurality of electrodes of the leadwire.
  • each of eight electrodes arranged at eight different locations along the longitudinal axis of the leadwire 120 are represented by respectively numbered vertically stacked regions of the leadwire model 204.
  • the leadwire model 204 can be horizontally orientated, in which the respectively number regions would be arranged horizontally beside one another.
  • the example display screen 200 further includes a region marking 206 that vertically
  • the leadwire model 204 spans those of the electrode representing regions that correspond to electrodes determined by the processor, e.g., by a currently performed calculation or by look-up of previously recorded data, to most closely correspond to an anatomic region or structure of significance with respect to particular stimulation-related information.
  • the anatomic region or structure of significance is that which is targeted for stimulation, e.g., as manually defined by user input or as automatically determined by the processor.
  • an electrode in an instance where at least one of the electrodes of the leadwire 120 passes through the region or structure of significance, an electrode is deemed by the processor to be sufficiently closely related to the region or structure of significance to be indicated as such conditional upon that the respective electrode is one of the electrodes that pass through the region or structure of significance.
  • FIG 3A shows an example stimulation significant region 300 through which the leadwire 120 passes, an example instance in which region marking 206 would identify only those electrodes that are at least partially within the stimulation significant region 300.
  • the region marking 206 would identify only those electrodes that are completely within the stimulation significant region 300.
  • the processor deems an electrode to be sufficiently closely related to the region or structure of significance to be indicated as such by the region marking 206 conditional upon that the electrode is within a boundary 302 whose boundary lines are drawn perpendicular to the central longitudinal axis of the leadwire 120 and define upper and lower limits of the stimulation significant region 300 with respect to the orientation of the boundary 302.
  • the region marking 206 shown in FIG. 2 is a box whose upper and lower limits are drawn such that all of the electrodes deemed to be sufficiently closely related to the stimulation significant region 300 are beside the box.
  • the region marking 206 is formed of two horizontal lines (where the leadwire model 204 has a vertical orientation) drawn such that all of the electrodes deemed to be sufficiently closely related to the stimulation significant region 300 are beside the region that is between the two horizontal lines.
  • the region marking 206 is a single vertical line (e.g., the left vertical line of the box shown in FIG. 2) that extends beside all of the electrodes deemed to be sufficiently closely related to the stimulation significant region 300.
  • whether an electrode is deemed sufficiently closely related to the stimulation significant region 300 is based on proximity of the electrode to the stimulation significant region 300 (in that it either passes through the region in the case shown in FIG. 3A or is within the boundary 302 in the case shown in FIG. 3B).
  • This information is important for a user because greater proximity of a first electrode to the stimulation significant region 300 than a second electrode suggests that the first electrode is likely a better candidate than the second electrode for contributing to the stimulation of the stimulation significant region 300.
  • the user may accordingly test settings with activation of the first electrode, e.g., at greater amplitude than that at which the second electrode is set, for the stimulation.
  • the region marking 206 is therefore presented as a two dimensional element, e.g., a box as shown in FIG. 2 or two horizontal lines bounding a region, such that the element covers a region in which other information is presented which can further factor into the user's decision for setting the stimulation parameters of the leadwire 120.
  • the leadwire model 204 and its numbered regions are arranged as values of the ordinate of a graph 208, and values for a particular stimulation parameter are arranged as the abscissa values of the graph 208.
  • FIG. 2 shown amplitude values as stimulation settings 210 for the abscissa of the graph 208.
  • values of other stimulation parameters can be used as the abscissa values.
  • the processor provides a user interface via which a user can select one of a plurality of stimulation parameters to use for the abscissa.
  • the leadwire model 204 can be horizontally arranged, in which case the electrodes would form the abscissa values and the values of the used parameter would form the ordinate values.
  • data corresponding to a stimulation associated with a particular electrode (or region to which the particular electrode is proximal) and associated with a particular one of the values of the represented stimulation parameter is plotted in the graph at the corresponding values (corresponding electrode and corresponding parameter value). For example, if an adverse side effect had been recorded to have occurred at a stimulation centered about electrode 3 at an amplitude of 3 mA, in an example embodiment, a node is plotted in the graph at the intersection of electrode 3 and 3 mA.
  • the user can identify which electrodes and amplitude settings are best candidates for stimulating the target region without producing an adverse side effect.
  • the recorded information is information previously recorded for the current patient for whom the target stimulation region has been identified and for whom stimulation parameters are being selected based on the output data.
  • information recorded for other patients is also represented.
  • Different types of information can be recorded in association with the electrode parameter value combinations. For example, particularly good therapeutic effects can be recorded.
  • more than one data category is representable in the graph.
  • the processor outputs graph nodes for both adverse side effects and therapeutic effects records.
  • different graphical markings can be used depending on the type of information, e.g., adverse side effect versus therapeutic effect, being represented.
  • the graphical markings representing the graph nodes are differently presented depending on variations in degree. For example, as described with respect to FIG.
  • degrees of such effects can also be input and recorded. Accordingly, the way in which a graph node representing, for example, an adverse side effect is displayed depends on the indicated severity of the adverse side effect. Similarly, the way in which a graph node representing, for example, a therapeutic effect is displayed depends on the indicated degree of therapeutic effect. It is possible for an adverse side effect or therapeutic effect to be recorded without an indication of degree of such effect. In an example embodiment, were no degree is indicated, the node is output in a manner specifically for an instance in which degree has not been indicated. Alternatively, where no degree is specified, a default degree is assigned to the data.
  • a green node is used to represent a therapeutic effect and a red node is used to represent an adverse side effect.
  • the greater degree of the effect the larger the displayed node.
  • different transparencies are used depending on degree.
  • the greater the degree of the adverse side effect the more opaque the red node.
  • a scale of color is used, where the greater the degree of the effect, the deeper the red or the green used for the display of the corresponding node.
  • the system graphically indicates the single electrode that intersects or is closest to (with respect to a region drawn perpendicularly to the central longitudinal axis of the leadwire 120 and that bounds upper and lower boundaries of the stimulation significant region 300) a significant sub-area within the stimulation significant region 300, e.g., the center or centroid of the stimulation significant region 300 or a region that has been user-indicated to have particular significance.
  • FIG. 4 shows a GUI display screen 400, similar to GUI display screen 200 shown in FIG. 2, but display screen 400 further includes an electrode marking 402 corresponding to a single electrode level corresponding to the significant sub-area within the stimulation significant region 300.
  • the region marking 206 and/or electrode marking 402 are provided to correspond to particular locations or levels of the leadwire with respect to its longitudinal axis.
  • the region marking 206 in FIG. 2 does not correspond to the entirety of electrodes 3 to 5, but rather includes the entirety of electrode 4, most of electrode 3, and approximately half of electrode 5, for example, because only parts of electrodes 3 and 5 are within stimulation significant region 300 or within boundary 302.
  • electrode marking 402 is at the very top of electrode 2.
  • the relevant upper and lower limits of the stimulation significant region 300 and/or significant sub-area within the stimulation significant region 300 corresponds to a level of the leadwire 120 at which there is no electrode, e.g., between electrodes
  • the upper and lower edges of the region marking 206 and/or the electrode marking 402 is placed at the relevant leadwire level at which none of the electrodes are represented, e.g., between two electrode representations.
  • settings of multiple electrodes can be set to center a stimulation between electrodes, such a center location being a virtual electrode location as described in the ⁇ 35 application.
  • the electrode marking 402 is positioned between two electrode representations, a user might therefore consider setting stimulation parameter settings for those two electrodes to center a stimulation at the virtual electrode position between them, which corresponds to the leadwire level at which the electrode marking 402 is drawn.
  • a leadwire model 204 with a marking showing those electrodes that are significant based on proximity to a stimulation significant region 300, such as a selected target stimulation region, in a graph that plots information corresponding to the electrodes (or virtual electrodes) at particular values of a selected stimulation parameter, provides a quick reference for a user to visually ascertain those electrodes for which settings can quickly and easily be ascertained, e.g., by trial and error, for producing a stimulation that will likely stimulate the target region, it is also of benefit to provide other interface displays with more detailed and/or other types of information relevant for selecting stimulation parameters, e.g., displays as described in the '330, '312, '340, '343, '314, and/or '232 applications.
  • such other displays can include one or more stimulation significant three-dimensional volumes. Additionally, it is useful for the user to be able to separately view such detailed graphical representations and the core electrode-location information described with respect to FIGS. 2 and 4 to observe how they relate to each other.
  • the system outputs a user interface with which a user can quickly switch between two (or more views) including the different graphical information.
  • FIGS. 2 and 4 show tabs 202a and 202b, where the above-described core electrode-location information is shown when the tab 202a is selected.
  • the user can select the tab 202b to view other types of information.
  • the system displays one or more of the graphical displays described with respect to the figures of the '232 application, e.g., including detailed three-dimensional side effect and/or therapeutic effect regions and/or gradients.
  • a region associated with adverse side effect and/or therapeutic effect is used as the stimulation significant region.
  • voxels are assigned respective scores, e.g., based on the number of stimulation regions associated with therapeutic effect in which the respective voxels were included and the number of stimulation regions associated with adverse side effect in which the respective voxels were included.
  • a score threshold can be selected, and, in an example embodiment, the region marking 206 is based on a region in which all or a majority of voxels are assigned scores that meet the threshold.
  • the regions of adverse side effect are regions recorded to have been associated with at least a threshold level of adverse side effect.
  • the regions of adverse side effect are regions recorded to have been associated with at least a threshold level of adverse side effect without at least a threshold level of therapeutic effect.
  • the regions of adverse side effect are regions assigned a score associated with adverse side effect, where the score is based on recorded data of adverse side effect and therapeutic effect, where recorded adverse side effects negatively impact the score and recorded therapeutic effects positively impact the score.
  • recorded data concerning adverse side effects and/or therapeutic effects are associated with tissue regions that have been previously stimulated. Often, adverse side effects are recorded for stimulation regions in which there is one or more smaller stimulation regions that resulted from other stimulations, which other smaller stimulation regions have been associated with therapeutic effect.
  • recorded adverse side effect regions can be separated by a therapeutic effect region.
  • multiple region markings 206 are output, each corresponding to a respective stimulation significant region 300.
  • a respective region marking 206 is output for each of the separate regions of adverse side effect.
  • FIG. 5 shows a GUI display screen 500 including a region marking 206a showing the vertical position, relative to the leadwire 120, of the anatomic region whose scores satisfy the score threshold.
  • the region marking 206a is a two-dimensional marking including a shaded area, in which transparency/opacity varies in accordance with changes in score.
  • the better the score the more opaque the part of the region marking 206a corresponding to the electrode location that is closest to that voxel.
  • an electrode might intersect both voxels of high score and low score. Therefore, according to an example embodiment, for an electrode that intersects voxels to which different scores are assigned, the opacity corresponding to the part of the region marking 206a that corresponds to the electrode is based on an average of the voxels' scores. Alternatively, another mathematical calculation can be used for selecting the opacity corresponding to the electrode (or leadwire level).
  • the processor performs a mathematical function whose input are the scores of all voxels within a region formed by planes drawn perpendicularly to the central longitudinal axis of the leadwire 120 and including the electrode, but assigns different weights to the voxel scores depending on proximity of the voxel to the electrode, where the closer the voxel is to the electrode, the greater its score is weighted.
  • the opacity/transparency is selected based on the highest scored voxel corresponding to the electrode (or leadwire level).
  • a region marking 206 corresponds to a target stimulation region
  • a region marking 206a corresponds to a therapeutic effect region
  • a region marking 206a is provided based on a combination of such information.
  • a target stimulation region is used as the boundary of the region marking 206a and variations in opacity/transparency within the region marking 206a are based on variations of voxel score within the target stimulation region. (It is noted that score threshold can itself be a factor for selecting the target stimulation region)
  • more than one region marking 206 or 206a is displayed, e.g., where more than one region is targeted for stimulation or where more than one region of voxels satisfies the score threshold.
  • opacity/transparency is also varied horizontally (not shown) within the region marking 206a depending on differences in voxel score depending on a selected parameter setting, e.g., amplitude, to the values of which the abscissa of the graph 208 corresponds.
  • a selected parameter setting e.g., amplitude
  • the opacity of the region marking 206a at a part of the graph 208 that corresponds to electrode 2 and 6mA is based on scores of voxels corresponding to electrode 2 as described above, but limited to stimulations at 6mA.
  • the system is configured to display a parameter recommendation marking 602 as shown in GUI display screen 600 of FIG. 6.
  • the parameter recommendation marking 602 is displayed at a level corresponding to a part of stimulation significant region 300, e.g., a target stimulation region or structure, e.g., the center or centroid thereof, and is extended at that level until a point of the graph 208 that corresponds to a relevant value for a predetermined (or user-selected) stimulation parameter.
  • the abscissa of graph 208 corresponds to amplitude values
  • the parameter recommendation marking 602 terminates at an amplitude value (between 2 and 3mA) recommended for stimulation of the target region or structure.
  • such a recommendation is obtained based on an algorithm that estimates an ideal amplitude setting for stimulating a region that best corresponds, e.g., based on, and, according to an example embodiment, considering a trade-off between, overlap and spill, to the target region or structure, e.g., as described in detail in U.S. Prov. Pat. App. Ser. Nos. 61/651,282 ("the '282 application"), filed August 28, 2012, the content of which is incorporated by reference herein in its entirety.
  • the parameter recommendation marking is displayed at a level corresponding to an electrode (or virtual electrode) recommended to be used.
  • the system displays both the parameter recommendation marking 602 and the region marking 206, e.g., as described with respect to any of FIGS. 2, 4, and 5 (the marking 206 described with respect to FIG. 2 being shown in FIG. 6).
  • the region marking 206 or 206a show boundaries of an adverse side effect or therapeutic effect region.
  • the parameter recommendation marking 602 shows the relationship between those electrodes corresponding to the adverse side effect or therapeutic effect region and the electrode corresponding to the target region or location or that is recommended to be used for stimulating the target region or location.

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  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Human Computer Interaction (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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Abstract

Selon la présente invention, un système et un procédé d'identification de manière graphique d'électrodes candidates d'un fil pour stimulation d'une anatomie de patient comprennent un processeur obtenant des données correspondant à une région anatomique, identifiant une relation spatiale entre des électrodes du fil à la région anatomique, sur la base de l'identification, sélectionnant un sous-ensemble des électrodes du fil, générant, sur la base des données obtenues et du sous-ensemble sélectionné, un agencement de sortie graphique qui comprend un modèle du fil comprenant des représentations graphiques d'au moins certaines des électrodes et un marquage de sélection graphique identifiant le sous-ensemble sélectionné des électrodes.
PCT/US2014/027782 2013-03-15 2014-03-14 Visualisation d'électrodes de fil de stimulation pertinentes par rapport à des informations de stimulation sélectionnées WO2014143709A1 (fr)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US201361793773P 2013-03-15 2013-03-15
US61/793,773 2013-03-15
US14/011,836 US9227074B2 (en) 2012-08-28 2013-08-28 Parameter visualization, selection, and annotation interface
US14/011,836 2013-08-28
US14/011,817 US9248296B2 (en) 2012-08-28 2013-08-28 Point-and-click programming for deep brain stimulation using real-time monopolar review trendlines
US14/011,870 US9643017B2 (en) 2012-08-28 2013-08-28 Capture and visualization of clinical effects data in relation to a lead and/or locus of stimulation
US14/011,870 2013-08-28
US14/011,817 2013-08-28

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007097861A1 (fr) * 2006-02-24 2007-08-30 Medtronic, Inc. Interface de programmation à vue transversale d'un fil de stimulation à géométrie d'électrode complexe
WO2009097224A1 (fr) * 2008-01-31 2009-08-06 Medtronic Inc. Caractérisation d'électrodes se stimulation électrique par imagerie post-implantaire
US20110172737A1 (en) * 2010-01-08 2011-07-14 Medtronic, Inc. Programming therapy delivered by implantable medical device
US20110307032A1 (en) * 2010-06-11 2011-12-15 Medtronic, Inc. Programming techniques for controlling rate of change of electrical stimulation therapy
US20120302912A1 (en) * 2011-05-27 2012-11-29 Boston Scientific Neuromodulation Corporation Collection of clinical data for graphical representation and analysis

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007097861A1 (fr) * 2006-02-24 2007-08-30 Medtronic, Inc. Interface de programmation à vue transversale d'un fil de stimulation à géométrie d'électrode complexe
WO2009097224A1 (fr) * 2008-01-31 2009-08-06 Medtronic Inc. Caractérisation d'électrodes se stimulation électrique par imagerie post-implantaire
US20110172737A1 (en) * 2010-01-08 2011-07-14 Medtronic, Inc. Programming therapy delivered by implantable medical device
US20110307032A1 (en) * 2010-06-11 2011-12-15 Medtronic, Inc. Programming techniques for controlling rate of change of electrical stimulation therapy
US20120302912A1 (en) * 2011-05-27 2012-11-29 Boston Scientific Neuromodulation Corporation Collection of clinical data for graphical representation and analysis

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