A PLANNING AND/OR CONTROL SYSTEM FOR A NEUROMODULATION SYSTEM

20210149552 · 2021-05-20

Assignee

Inventors

Cpc classification

International classification

Abstract

A planning and/or control system for a system for providing neuromodulation, especially neurostimulation, at least comprising: a graphical presentation module configured and arranged for providing graphical information about an electrode array comprising multiple electrodes and/or an implantation side for the electrode array comprising at least one target area, a selection module configured and arranged for determining a stimulation zone and/or a stimulation direction on the electrode array comprising at least one electrode and/or for individually selecting at least one electrode and/or for selecting at least one target area, a calculation module configured and arranged for determining a contribution of currents provided by electrodes of the stimulation zone and/or stimulation direction on the electrode array and/or the at least one electrode selected and/or to the at least one target area selected.

Claims

1. A planning and/or control system for a system for providing neuromodulation, comprising: a graphical presentation module configured and arranged for providing graphical information about an electrode array comprising multiple electrodes and/or an implantation side for the electrode array comprising at least one target area, a selection module configured and arranged for determining a stimulation zone and/or a stimulation direction on the electrode array comprising at least one electrode and/or for individually selecting at least one electrode and/or for selecting at least one target area, a calculation module configured and arranged for determining a contribution of currents provided by electrodes of the stimulation zone and/or stimulation direction on the electrode array and/or the at least one electrode selected and/or to the at least one target area selected.

2. The system according to claim 1, wherein the graphical presentation module is configured and arranged for providing graphical information about the electrode array comprising actual physical electrodes and/or virtual electrodes.

3. The system according to claim 2, wherein the calculation module is configured and arranged for determining an equal contribution of currents provided by the electrodes of the stimulation zone (Z) and/or stimulation direction and/or the one or more electrodes individually selected and/or to the at least one target area selected.

4. The system according to claim 2, wherein the calculation module is configured and arranged for determining a weighted contribution of provided by the electrodes of the stimulation zone and/or stimulation direction and/or the one or more electrodes individually selected and/or to the at least one target area selected.

5. The system according to claim 4, wherein the calculation module is configured and arranged for determining the weighted contribution of currents provided by the electrodes of the stimulation zone and/or stimulation direction by calculating a Euclidean distance from an electrode to the stimulation zone and/or stimulation direction and/or to at least one point of the stimulation zone and/or stimulation direction.

6. The system according to claim 4, wherein the calculation module is configured and arranged for determining the weighted contribution of currents provided by the electrodes of the stimulation zone and/or the stimulation direction and/or at least one electrode individually selected based on a generated field of neighbor electrodes.

7. The system according to claim 4, wherein the calculation module is configured and arranged for determining the weighted contribution of currents provided by the electrodes of the stimulation zone and/or the stimulation direction and/or the at least one electrode individually selected and/or to the at least one target area selected by a numerical method.

8. The system according to one of claim 1, wherein the system further comprises at least one of a display, a controller, a programmer, a communication module, a telemetry module, a stimulation device, an electrode, a sensor and/or a sensor network.

9. The system according to claim 1, wherein the system further comprises at least one computer-assisted module configured and arranged for at least partially automatically determining a stimulation zone and/or a stimulation direction on the electrode array comprising at least one electrode and/or for at least partially automatically selecting at least one electrode.

10. The system according to claim 7, wherein the calculation module is be configured and arranged to feature an algorithm to determine the weighted contribution of currents to a benefit of power efficiency.

11. A method for planning neuromodulation comprising the steps of: providing graphical information about an electrode array comprising multiple electrodes and/or an implantation side for the electrode array comprising at least one target area, determining a stimulation zone and/or a stimulation direction on the electrode array comprising at least one electrode and/or individually selecting at least one electrode and/or selecting at least one target area, determining a contribution of currents provided by electrodes of the stimulation zone and/or the stimulation direction on the electrode array and/or the at least one electrode selected and/or to at least one selected target area.

12. The method according to claim 11, wherein the graphical information about the electrode array comprises actual physical electrodes and/or virtual electrodes.

13. The method according to claim 12, wherein the method further comprises a step of determining an equal contribution of currents provided by the electrodes of the stimulation zone and/or the stimulation direction and/or at least one electrode individually selected and/or to the at least one target area selected.

14. The method according to claim 12, wherein the method further comprises a step of determining a weighted contribution of currents provided by the electrodes of the stimulation zone and/or the stimulation direction and/or at least one electrode individually selected and/or to the at least one target area selected.

15. The method according to claim 14, wherein the method further comprises the step of determining the weighted contribution of currents provided by the electrodes of the stimulation zone and/or the stimulation direction by calculating a Euclidean distance from an electrode to the stimulation zone and/or the stimulation direction and/or to at least one point of the stimulation zone and/or at least one stimulation direction.

16. The method according to claim 14, wherein the method further comprises the step of determining the weighted contribution of currents provided by the electrodes of the stimulation zone and/or the stimulation direction and/or the at least one electrode individually selected based on a generated field of neighbor electrodes.

17. The method according to claim 14, wherein the method further comprises the step of determining the weighted contribution of currents provided by the electrodes of the stimulation zone and/or the stimulation direction and/or at least one electrode individually selected and/or to the at least one target area selected by a numerical method.

18. The method according to claim 10, wherein the method further comprises the step of least partially automatically determining a stimulation zone and/or a stimulation direction on the electrode array comprising at least one electrode and/or for at least partially automatically selecting at least one electrode.

19. The method according to claim 18, wherein the method further comprises the step of featuring an algorithm to determine the weighted contribution of currents to the benefit of power efficiency.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0059] Further details and advantages of the present invention shall now be disclosed in connection with the drawings.

[0060] It is shown in:

[0061] FIG. 1 a schematical overview of an embodiment of the planning and/or control system for a system for providing neuromodulation, especially neurostimulation according to the present invention, with which the method according to the present invention may be performed;

[0062] FIG. 2 an example of an equal contribution of currents provided by individually selected electrodes of an electrode array, according to the present invention;

[0063] FIG. 3 an example of weighted contribution of currents provided by electrodes of a determined stimulation zone of an electrode array, according to the present invention;

[0064] FIG. 4 an example of an embodiment of an electrode array, comprising virtual electrodes, according to the present invention;

[0065] FIG. 5 an example of determining a stimulation direction, according to the present invention;

[0066] FIG. 6 two examples of graphical information provided by the graphical presentation module, combining an electrode array with a target area, according to the present invention;

[0067] FIG. 7 a further example of graphical information provided by the graphical presentation module, combining an electrode array with at least one possible target area, according to the present invention; and

[0068] FIG. 8 a further example of graphical information provided by the graphical presentation module, according to the present invention.

DETAILED DESCRIPTION

[0069] FIG. 1 shows a schematical overview of an embodiment of the planning and/or control system 10 for a system for providing neuromodulation, especially neurostimulation according to the present invention, with which the method according to the present invention may be performed.

[0070] The system 10 comprises a graphical presentation module 12, a selection module 14, and a calculation module 16. In some examples, the graphical presentation module 12, the selection module 14, and the calculation module 16 may be present on a single device, or one or more of the graphical presentation module 12, the selection module 14, and the calculation module 16 may be present on separate devices. The device(s) comprising the graphical presentation module 12, the selection module 14, and the calculation module 16 may include memory, one or more processors, and a communication subsystem, though other components and modules may also be included as known to those of skill in the art. In some aspects, the device(s) comprising the graphical presentation module 12, the selection module 14, and the calculation module 16 may be coupled to a user input device, a display, an electrode array comprising one or more electrodes, and/or other peripheral components.

[0071] Collectively, the various tangible components or a subset of the tangible components of the planning and/or control system 10 may be referred to herein as “logic” configured or adapted in a particular way, for example as logic configured or adapted with particular software, hardware, or firmware and adapted to execute computer readable instructions. The processors may be single core or multicore, and the programs executed thereon may be configured for parallel or distributed processing. The processors may optionally include individual components that are distributed throughout two or more devices, which may be remotely located and/or configured for coordinated processing. One or more aspects of the logic subsystem may be virtualized and executed by remotely accessible networked computing devices configured in a cloud computing configuration, that is, one or more aspects may utilize ubiquitous, convenient, on-demand network access to a shared pool of configurable computing resources that can be rapidly provisioned and released with minimal management effort or service provider interaction. Clouds can be private, public, or a hybrid of private and public, and may include Infrastructure as a Service (IaaS), Platform as a Service (PaaS) and Software as a Service (SaaS). In some aspects, logic and memory may be integrated into one or more common devices, such as an application specific integrated circuit, field programmable gate array, or a system on a chip.

[0072] In some embodiments, one or more of the device(s) of the planning and/or control system 10 may be any computing or mobile device, for example, mobile devices, tablets, laptops, desktops, PDAs, and the like, as well as virtual reality devices or augmented reality devices. Thus, in some embodiments, the device(s) may include a display and thus a separate display or user input device may not be necessary. In other aspects, the device(s) may be coupled to a plurality of displays.

[0073] The memory generally comprises a random-access memory (“RAM”) and permanent non-transitory mass storage device, such as a hard disk drive or solid-state drive. The memory may store an operating system as well as the various modules and components discussed herein. It may further include devices which are one or more of volatile, non-volatile, dynamic, static, read/write, read-only, random access, sequential access, location addressable, file addressable and content addressable.

[0074] The communication subsystem may be configured to communicatively couple the modules within a device as well as communicatively coupling a device with one or more other computing and/or peripheral devices. Such connections may include wired and/or wireless communication devices compatible with one or more different communication protocols including, but not limited to, the Internet, a personal area network, a local area network (LAN), a wide area network (WAN) or a wireless local area network (WLAN). For example, wireless connections may be WiFi, Bluetooth®, IEEE 802.11, and the like.

[0075] In this embodiment, the graphical presentation module 12 is configured and arranged for providing graphical information about an electrode array A comprising multiple electrodes E, V and/or an implantation side for the electrode array A comprising at least one target area X.

[0076] The system 10 further comprises the selection module 14.

[0077] In this embodiment, the selection module 14 is configured and arranged for determining a stimulation zone Z and/or a stimulation direction D on the electrode array A comprising at least one electrode E, V and/or for individually selecting at least one electrode E, V and/or for selecting at least one target area X.

[0078] The system 10 further the a calculation module 16.

[0079] In this embodiment, the calculation module 16 is configured and arranged for determining a contribution of currents provided by electrodes E, V of the stimulation zone Z and/or stimulation direction D on the electrode array A and/or the at least one electrode E, V selected and/or a to the at least one target area X selected.

[0080] In this embodiment, the graphical presentation module 12, the selection module 14 and the calculation module 16 are connected.

[0081] In this embodiment, the graphical presentation module 12, the selection module 14 and the calculation module 16 are connected via a bidirectional connection.

[0082] In this embodiment, the graphical presentation module 12, the selection module 14 and the calculation module 16 are connected via a wireless link.

[0083] However, in an alternative embodiment, a unidirectional and/or cable-bound connection between the graphical presentation module 12, the selection module 14 and/or the calculation module 16 could be generally possible.

[0084] In this embodiment, the graphical presentation module 12 provides graphical information about an electrode array A comprising multiple electrodes E, V.

[0085] In an alternative embodiment, the graphical presentation module 12 could provide additionally and/or alternatively graphical information abound an implantation side for the electrode array A comprising at least one target area X.

[0086] Not shown in this embodiment is that the graphical information about the implantation site could be patient-specific data.

[0087] Not shown in this embodiment is that the graphical information about the implantation site could be patient-specific MRI data, X-Ray data, pictures obtained during surgery, etc.

[0088] In this embodiment, the selection module 14 determines a stimulation zone Z.

[0089] In this embodiment, the selection module 14 determines a stimulation zone Z based on a user input.

[0090] Not shown in this embodiment is that the selection module 14 could generally comprise a user interface.

[0091] In an alternative embodiment, the selection module 14 could additionally and/or alternatively determine a stimulation direction D on the electrode array A comprising at least one electrode E, V and/or for selecting at least one target area X, based on user input.

[0092] Not shown in FIG. 1 is that the system 10 could further comprise at least one of a display, a controller, a programmer, a communication module, a telemetry module, a stimulation device, an electrode, a sensor and/or a sensor network, as described above. For example, each of the modules described herein could be included as part of or coupled to a controller, where the controller includes a non-transitory memory (e.g., the memory described above) storing instructions that are executable by a processor (e.g., the processor described above) to perform the functions described herein.

[0093] Not shown in this embodiment is that the graphical presentation module 12 could in general provide graphical information about an electrode array A comprising actual physical electrodes E and/or virtual electrodes V.

[0094] Not shown in this embodiment is that virtual electrodes V could be selected for stimulation.

[0095] Not shown in FIG. 1 is that virtual electrodes V may be more understandable and graspable to the user than current-weighting or current-steering in percentages and/or absolute numbers.

[0096] Not shown in FIG. 1 is that it could be generally possible that the calculation module 16 could be configured and arranged for determining an equal contribution of currents provided by the electrodes E, V of the stimulation zone Z and/or the stimulation direction D and/or the one or more electrodes E, V individually selected and/or to the at least one target area X selected.

[0097] Not shown in FIG. 1 is that it could be generally possible that the calculation module 16 could be configured and arranged for determining a weighted contribution of currents provided by the electrodes E, V of the stimulation zone Z and/or stimulation direction D and/or the at least one electrode E, V individually selected and/or to the at least one target area X selected.

[0098] Not shown in FIG. 1 is that it could be generally possible that the calculation module 16 could be configured and arranged for determining the weighted contribution of currents provided by the electrodes E, V of the stimulation zone Z and/or stimulation direction D by calculating the Euclidean distance from an electrode E, V to the stimulation zone Z and/or stimulation direction D and/or to at least one point of the stimulation zone Z and/or stimulation direction D.

[0099] Further not shown in FIG. 1 is that it could be generally possible that the calculation module 16 could be configured and arranged for determining the weighted contribution of currents provided by the electrodes E, V of the stimulation zone Z and/or the stimulation direction D and/or at least one electrode E, V individually selected based on a generated field of neighbor electrodes E, V.

[0100] In particular, from an activation line such as a stimulation vector and/or a stimulation direction D, it could be calculated which neighboring electrodes E, V can create a field in this direction and weighting factors could be determined.

[0101] Further not shown in FIG. 1 is that it could be generally possible that the calculation module 16 could be configured and arranged for determining the weighted contribution of currents provided by the electrodes E, V of the stimulation zone Z and/or the stimulation direction D and/or the at least one electrode E, V individually selected and/or to the at least one target area X selected by a numerical method.

[0102] In general, instead of analytical models, a numerical method could be used, using a personalized patient model M, e.g. a MRI based patient model M, that includes both targeted and unwanted (cross-talk) nerve locations, and which has computed for N electrode E, V configurations the 3D potential distributions, as well as the activation potentials/selectivity indices.

[0103] Not shown in FIG. 1 is that the system 10 could further comprise at least one computer-assisted module configured and arranged for at least partially automatically determining a stimulation zone Z and/or a stimulation direction D on the electrode array A comprising at least one electrode E, V and/or for at least partially automatically selecting at least one electrode E, V, optionally based on medical imaging superimposing, cf. FIG. 6.

[0104] Not shown in FIG. 1 is that the calculation module 16 could generally feature an algorithm to determine the weighted contribution of currents to the benefit of power efficiency.

[0105] Based on the electrodes E, V of the stimulation zone Z and/or the stimulation direction D and/or the at least one electrode E, V individually selected and/or the at least one target area X indicated by the user, the calculation module 16 could use a (pre-computed, or online calculated) neuronal activation model, to optimize the weighting of electrode E, V intensities for maximizing the selectivity index, or for maximizing the target while minimizing the sensitive areas.

[0106] In general, the system 10 could perform a method for planning neuromodulation, especially neurostimulation, at least comprising the steps of:

providing graphical information about an electrode array A comprising multiple electrodes E, V and/or an implantation side for the electrode array A comprising at least one target area X,
determining a stimulation zone Z and/or a stimulation direction D on the electrode array A comprising at least one electrode E, V and/or individually selecting at least one electrode E, V and/or selecting at least one target area X,
determining a contribution of currents provided by electrodes E, V of the stimulation zone Z and/or the stimulation direction D on the electrode array A and/or the at least one electrode E, V selected and/or to the at least one selected target area X.

[0107] In general, the graphical information about the electrode array A could comprise actual physical electrodes E and/or virtual electrodes V.

[0108] The method could further comprise the step of determining an equal contribution of currents provided by the electrodes E, V of the stimulation zone Z and/or the stimulation direction D and/or at least one electrode E, V individually selected and/or to the at least one target area X selected.

[0109] The method could further comprise the step of determining a weighted contribution of currents provided by the electrodes E, V of the stimulation zone Z and/or the stimulation direction D and/or at least one electrode E, V individually selected and/or to the at least one target area X selected.

[0110] The method could further comprise the step of determining the weighted contribution of currents provided by the electrodes E, V of the stimulation zone Z and/or the stimulation direction D by calculating the Euclidean distance from an electrode E, V to the stimulation zone Z and/or the stimulation direction D and/or to at least one point of the stimulation zone Z and/or stimulation direction D.

[0111] The method cold further comprises the step of determining the weighted contribution of currents provided by the electrodes E, V of the stimulation zone Z and/or the stimulation direction D and/or the at least one electrode E, V individually selected based on a generated field of neighbor electrodes E, V.

[0112] The method could further comprise the step of determining the weighted contribution of currents provided by the electrodes E, V of the stimulation zone Z and/or the stimulation direction D and/or at least one electrode E, V individually selected and/or to the at least one target area X selected by a numerical method.

[0113] The method could further comprise the step of least partially automatically determining a stimulation zone Z and/or a stimulation direction D on the electrode array A comprising at least one electrode E, V and/or for at least partially automatically selecting at least one electrode E, V, optionally based on medical imaging superimposing.

[0114] The method could further comprise the step of featuring an algorithm to determine the weighted contribution of currents to the benefit of power efficiency.

[0115] In general, the weighting may be presented as absolute numbers (e.g. in V, mA, A) and/or expressed as percentage of total current applied by involved electrodes E, V.

[0116] Examples of how to determine a stimulation zone Z and/or stimulation direction D and/or select individual electrodes E, V and/or at least one target area X are disclosed in FIGS. 2, 3, 4, 5, 6, 7 and/or 8.

[0117] FIG. 2 shows an example of an equal contribution of currents provided by individually selected electrodes E, V of an electrode array A, determined by the calculation module 16 of the system 10 disclosed in FIG. 1.

[0118] In this embodiment, the graphical information provided by the graphical presentation module 12 of the system 10 disclosed in FIG. 1 comprises an electrode array A comprising 16 electrodes E.

[0119] In this embodiment, the system 10 is connected to a system for neuromodulation, comprising an electrode array A′.

[0120] In this embodiment, the electrode array A comprising 16 electrodes E provided by the graphical presentation module 12 reflects an electrode array A′ of a related neuromodulation system configured and arranged for providing neuromodulation to a patient.

[0121] In this embodiment, the selection module 14 comprises a user interface.

[0122] In this embodiment, the selection module 14 comprises a graphical user interface.

[0123] In this embodiment, the selection module 14 is configured and arranged for individually selecting at least one electrode E of the electrode array A.

[0124] In this embodiment, the selection module 14 is configured and arranged for individually selecting at least one electrode E of the electrode array A based on a user input.

[0125] The shown embodiment is a display of a tablet computer, in particular a touch screen.

[0126] However, in general, any display and/or touch screen and/or programmer and/or mobile device could be possible.

[0127] In this embodiment, the display discloses the graphical information provided by the graphical presentation module 12.

[0128] In this embodiment, the user selects electrodes E of the electrode array A′ by touching with a finger on the touch screen, in particular on respective electrodes E of the electrode array A on the display.

[0129] Alternatively, the electrodes E could be selected via a mouse click.

[0130] In general, it could be possible that the electrodes E are selected by a mouse and/or a trackball and/or a joystick, a display and/or a touch screen and/or a touch pad and/or an acoustic signal and/or acoustic tone and/or a verbal command input.

[0131] In general, the selection module 14 could allow a user to actuate at least one control element, including but not limited to axes, points, knots, buttons, arrows, hand signals, emojis, crosses and/or windows and/or text and/or shortcuts.

[0132] In this embodiment, the user input is translated by the calculation module 16 into a certain weighting that could then be sent to the neuromodulation system for providing neuromodulation.

[0133] In this embodiment, the neuromodulation provided by the system for providing neuromodulation is modified according to the user input.

[0134] In this embodiment, the calculation module 16 of the system 10 disclosed in FIG. 1 determines an equal contribution of currents provided by three electrodes E individually selected.

[0135] In this embodiment, the calculation module 16 of the system 10 disclosed in FIG. 1 determines an equal contribution of currents provided by electrodes E 2, 7 and 8 individually selected.

[0136] In this embodiment, the calculation module 16 of the system 10 disclosed in FIG. 1 determines an equal contribution of currents provided by three anodes individually selected.

[0137] In this embodiment, each selected anode comprises 33.33% current sourcing.

[0138] In this embodiment, the calculation module 16 translates electrodes E of an electrode array A individually selected into an equal weighting on a real electrode array A′ comprising electrodes E, for stimulating a patient.

[0139] Not shown in FIG. 2 is that the electrode array A′ of the related neuromodulation system could provide neuromodulation, in particular neurostimulation to a patient based on the determined current sourcing.

[0140] FIG. 3 shows an example of weighted contribution of currents provided by electrodes E of a determined stimulation zone Z of an electrode array A, determined by the calculation module 16 of the system 10 disclosed in FIG. 1.

[0141] In this embodiment, the graphical information provided by the graphical presentation module 12 of the system 10 disclosed in FIG. 1 comprises an electrode array A.

[0142] In this embodiment, the electrode array A comprises 16 electrodes E.

[0143] In this embodiment, the electrode array A comprising 16 electrodes E provided by the graphical presentation module 12 reflects an electrode array A′ of a neuromodulation system configured and arranged for providing neuromodulation to a patient.

[0144] In this embodiment, the selection module 14 comprises a user interface.

[0145] In this embodiment, the selection module 14 comprises a graphical user interface.

[0146] In this embodiment, the selection module 14 is configured and arranged for determining at least one stimulation zone Z.

[0147] In this embodiment, the selection module 14 is configured and arranged for determining at least one stimulation zone Z based on a user input.

[0148] The shown embodiment is a display of a tablet computer, in particular a touch screen.

[0149] However, in general, any display and/or touch screen and/or programmer and/or mobile device could be possible.

[0150] In this embodiment, the display discloses the graphical information provided by the graphical presentation module 12.

[0151] In this embodiment, the user determines a stimulation zone Z by touching with a finger on the touch screen.

[0152] Alternatively, the stimulation zone could be determined via a mouse click.

[0153] In general, it could be possible that the stimulation zone and/or stimulation direction D is determined by a mouse and/or a trackball and/or a joystick, a display and/or a touch screen and/or a touch pad and/or an acoustic signal and/or acoustic tone and/or a verbal command input.

[0154] In general, the selection module 14 could allow a user to actuate at least one control element, including but not limited to axes, points, knots, buttons, arrows, hand signals, emojis, crosses and/or windows and/or text and/or shortcuts.

[0155] This user input could generally be translated by the calculation module 16 into a certain weighting that could then be sent to a neuromodulation system for providing neuromodulation.

[0156] In this embodiment, the system 10 is connected to a system for neuromodulation, comprising an electrode array A′.

[0157] In this embodiment, the user input is translated by the calculation module 16 into a certain weighting that could then be sent to the neuromodulation system for providing neuromodulation.

[0158] In this embodiment, the neuromodulation provided by the system for providing neuromodulation can be modified according to a modification of the user input.

[0159] In this embodiment, the calculation module 16 of the system 10 disclosed in FIG. 1 determines

[0160] a weighted contribution of currents provided by the electrodes E of the stimulation zone Z.

[0161] In this embodiment, the calculation module 16 of the system 10 disclosed in FIG. 1 determines

[0162] a weighted contribution of currents provided by the electrodes E of the stimulation zone Z, with two anodes comprising 40% of current sourcing and one anode comprising 20% of current sourcing.

[0163] Not shown in this embodiment is that the weighted contribution of currents provided by the electrodes E of the stimulation zone Z is determined by calculating the Euclidean distance from the electrodes E to the center C of the stimulation zone Z.

[0164] Not shown in this embodiment is that the weighted contribution of currents provided by the electrodes E of the stimulation zone Z is determined by calculating the Euclidean distance from the electrodes E to any other point on the electrode array A, including the stimulation zone Z.

[0165] In this embodiment, the calculation module 16 translates the selected stimulation zone Z of an electrode array A into a different weighting on a real electrode array A′ comprising electrodes E, for stimulating a patient.

[0166] Not shown in FIG. 3 is that the electrode array A′ of the related neuromodulation system could provide neuromodulation, in particular neurostimulation to a patient based on the determined current sourcing.

[0167] FIG. 4 shows an example of an embodiment of an electrode array A, comprising virtual electrodes V, according to the present invention.

[0168] In this embodiment, the system 10 is connected to a system for neuromodulation, comprising an electrode array A′ (actual physical electrode array A′ comprising actual physical electrodes E).

[0169] The shown example shows an actual physical electrode array A′ (left) as well as a display of a tablet computer, in particular a touch screen (right).

[0170] In this embodiment, the display discloses the graphical information provided by the graphical presentation module 12.

[0171] However, in general, any display and/or touch screen and/or programmer and/or mobile device could be possible.

[0172] In this embodiment, the graphical information provided by the graphical presentation module 12 of the system 10 disclosed in FIG. 1 comprises an electrode array A.

[0173] In this embodiment, the graphical information provided by the graphical presentation module 12 of the system 10 disclosed in FIG. 1 comprises an electrode array A, comprising multiple electrodes E, V.

[0174] In this embodiment, the electrode array A disclosed by the graphical presentation module 12 comprises 16 physical electrodes E.

[0175] In this embodiment, the electrode array A′ of the actual physical electrode array A comprises 16 physical electrodes E.

[0176] In an alternative embodiment, the electrode array A could comprise any other number of physical electrodes E.

[0177] In this embodiment, the 16 physical electrodes E of the electrode array A relate to the 16 physical electrodes of the actual physical electrode array A′ comprised in the neuromodulation system related to the system 10 disclosed in FIG. 1.

[0178] In this embodiment, the electrode array A comprises 10 virtual electrodes V.

[0179] In this embodiment, the 10 virtual electrodes V do not relate to physical electrodes of an actual physical electrode array A′ comprised in a neuromodulation system related to the system 10 disclosed in FIG. 1.

[0180] In other words, the 10 virtual electrodes V allow to go from 16 electrodes E present on an electrode array A to 26 electrodes E, V.

[0181] Not shown in FIG. 4 is that any number of virtual electrodes V could be added to the electrodes E.

[0182] In this embodiment, the selection module 14 comprises a user interface.

[0183] In this embodiment, the selection module 14 comprises a graphical user interface.

[0184] In this embodiment, the selection module 14 is configured and arranged for selecting electrodes E, V.

[0185] In this embodiment, the selection module 14 is configured and arranged for selecting electrodes E, V based on a user input.

[0186] In this embodiment, the user determines a stimulation zone Z on the electrode array A′ by selecting actual physical electrodes E and virtual electrodes V on the electrode array A shown on the display.

[0187] In this embodiment, the stimulation zone Z is determined by selecting electrodes E, V via a mouse click.

[0188] In general, it could be possible that the stimulation zone and/or a stimulation direction D is determined by a mouse and/or a trackball and/or a joystick, a display and/or a touch screen and/or a touch pad and/or an acoustic signal and/or acoustic tone and/or a verbal command input.

[0189] In general, the selection module 14 could allow a user to actuate at least one control element, including but not limited to axes, points, knots, buttons, arrows, hand signals, emojis, crosses and/or windows and/or text and/or shortcuts.

[0190] This user input could generally be translated by the calculation module 16 into a certain weighting that could then be sent to a neuromodulation system for providing neuromodulation.

[0191] This user input, thus the selection of physical electrodes E and virtual electrodes V on an electrode array A could generally be translated by the calculation module 16 into a certain weighting (equal or unequal) that could then be sent to a neuromodulation system for providing neuromodulation via an electrode array A′ comprising physical electrodes E.

[0192] Not shown in FIG. 4 is that the virtual electrodes V that can be selected for stimulation could be more understandable and graspable to the user than current-weighting or current-steering in percentages.

[0193] Not shown in FIG. 4 is that while selecting and/or interacting with virtual electrodes V, at least one key performance indicator, such as the selectivity index could be provided, in particular as graphical information provided by the graphical presentation module 12.

[0194] Not shown in FIG. 4 is that while selecting and/or interacting with virtual electrodes V, at least one key performance indicator, such as the selectivity index could be provided dynamically, in particular as graphical information provided by the graphical presentation module 12.

[0195] FIG. 5 shows an example of determining a stimulation direction D, according to the present invention.

[0196] The shown embodiment is a display of a tablet computer, in particular a touch screen.

[0197] However, in general, any display and/or touch screen and/or programmer and/or mobile device could be possible.

[0198] In this embodiment, the display discloses the graphical information provided by the graphical presentation module 12.

[0199] In this embodiment, the graphical information provided by the graphical presentation module 12 of the system 10 disclosed in FIG. 1 comprises an electrode array A.

[0200] In this embodiment, the selection module 14 comprises a user interface.

[0201] In this embodiment, the selection module 14 comprises a graphical user interface.

[0202] In this embodiment, the selection module 14 is configured and arranged for determining a stimulation direction D.

[0203] In this embodiment, the selection module 14 is configured and arranged for determining at least one stimulation direction D based on a user input.

[0204] In this embodiment, the user determines a stimulation direction D by touching with a finger on the touch screen and moving the finger.

[0205] In this embodiment, the stimulation direction D is a vector.

[0206] Alternatively, the stimulation direction D could be determined via a mouse click.

[0207] In general, it could be possible that the stimulation direction D is determined by a mouse and/or a trackball and/or a joystick, a display and/or a touch screen and/or a touch pad and/or an acoustic signal and/or acoustic tone and/or a verbal command input.

[0208] In general, the selection module 14 could allow a user to actuate at least one control element, including but not limited to axes, points, knots, buttons, arrows, hand signals, emojis, crosses and/or windows and/or text and/or shortcuts.

[0209] This user input could generally be translated by the calculation module 16 into a certain weighting that could then be sent to a neuromodulation system for providing neuromodulation.

[0210] Not shown in FIG. 5 is that the stimulation direction D on the electrode array A comprises electrodes E.

[0211] Not shown in FIG. 5 is that the calculation module 16 of the system 10 disclosed in FIG. 1 determines a weighted contribution of currents provided by the electrodes E of the stimulation direction D.

[0212] In general, the user input could generally be translated by the calculation module 16 into a certain weighting that could then be sent to a neuromodulation system for providing neuromodulation.

[0213] Not shown in FIG. 5 is that the calculation module 16 of the system 10 disclosed in FIG. 1 could generally determine a weighted contribution of currents provided by the electrodes E of the stimulation direction D or an equal contribution of currents provided by the electrodes E of the stimulation direction D.

[0214] FIG. 6 shows two examples of graphical information provided by the graphical presentation module, combining an electrode array A with a target area X, according to the present invention.

[0215] The shown embodiment (both examples) is a display of a tablet computer, in particular a touch screen.

[0216] However, in general, any touch screen and/or programmer and/or mobile device could be possible.

[0217] In this embodiment, the display discloses the graphical information provided by the graphical presentation module 12 of the system 10 disclosed in FIG. 1.

[0218] In this embodiment, the selection module 14 comprises a user interface.

[0219] In this embodiment, the selection module 14 comprises a graphical user interface.

[0220] In this embodiment, the electrode array A is comprised in a lead L.

[0221] In this embodiment, the lead L is superimposed on a target area X.

[0222] In this embodiment, the graphical information provided by the graphical presentation module 12 of the system 10 disclosed in FIG. 1 comprises an electrode array A and a target area X.

[0223] Left: In this embodiment, the target area X is provided as patient specific data obtained my MRI.

[0224] However, it could be generally possible, that the target area X is provided as patient specific data obtained by other methods, such as X-Ray, CT, or pictures obtained during surgery.

[0225] Right: In this embodiment, the target area X is a reconstruction.

[0226] In this embodiment, the target area X is a model M.

[0227] In general, the target area X could be provided as a 2D model M and/or a 3D model M.

[0228] Not shown in FIG. 6 is that the user could place the electrode array A on at least one target area X by touching with his finger on the electrode array A and moving the electrode array A with his finger.

[0229] Not shown in FIG. 6 is that a computer-assisted module could at least partially automatically determining a stimulation zone Z and/or a stimulation direction D on the electrode array A comprising at least one electrode E, V and/or for at least partially automatically selecting at least one electrode E, V optionally based on the medical imaging superimposing and/or a model M.

[0230] It could be generally possible that the electrode array A is superimposed on a medical image and/or model.

[0231] FIG. 7 shows a further example of graphical information provided by the graphical presentation module, combining an electrode array A with at least one possible target area X, according to the present invention.

[0232] The shown embodiment (both examples) is a display of a tablet computer, in particular a touch screen.

[0233] However, in general, any touch screen and/or programmer and/or mobile device could be possible.

[0234] In this embodiment, the display discloses the graphical information provided by the graphical presentation module 12 of the system 10 disclosed in FIG. 1.

[0235] In this embodiment, the selection module 14 comprises a user interface.

[0236] In this embodiment, the selection module 14 comprises a graphical user interface.

[0237] In this embodiment, the graphical information provided by the graphical presentation module 12 of the system 10 disclosed in FIG. 1 comprises an electrode array A and different possible target areas X.

[0238] In this embodiment, the electrode array A is comprised in a lead L.

[0239] In this embodiment, different possible target areas X with a superimposed lead L are shown.

[0240] In this embodiment, the different possible target areas X are shown as buttons B.

[0241] In this embodiment, a user can select at least one target area X by selecting at least one corresponding button B, e.g. by touching the corresponding button B with a finger.

[0242] Alternative ways of selection are disclosed for FIG. 1, 2, 3, 4, 5, 6.

[0243] In this embodiment, the different possible target areas X are provided schematically as spinal cord and pairs of spinal nerves, i.e. pairs of thoracic nerves T11, T12 and lumbar nerves L1, L2.

[0244] In an alternative embodiment, the different possible target areas X could alternatively and/or additionally include muscles (e.g. leg/trunk muscles) and/or organs.

[0245] In general, muscles and/or organs could be positioned under an electrode array A and/or a lead L and/or or next to an electrode array A and/or a lead L.

[0246] However, in an alternative embodiment, the different possible target areas X could be provided as any spinal nerve and/or any combination of at least two spinal nerves.

[0247] In general, the at least one target area X could be or could comprise fictious and/or realistic anatomical conditions of a mammal, in particular a human being, such as the patient himself.

[0248] In general, the at least one target area X could be or could comprise at least one target nerve and/or nerve fiber and/or dorsal root and/or area of the spinal cord and/or tissue and/or area related to the spinal cord and/or muscle fiber and/or muscle.

[0249] In general, image data and/or 2D models M and/or 3D models M could be used as target area X for visual representation of anatomy of the patient, e.g. the dorsal roots.

[0250] In this embodiment, the user can select at least one target area X, i.e. left and/or right thoracic nerve T11 and/or T12 and/or left and/or right lumbar nerve L1 and/or L2.

[0251] In this embodiment, the user can select at least one target area X, i.e. left and/or right thoracic nerve T11 and/or T12 and/or left and/or right lumbar nerve L1 and/or L2 by selecting the respective button B.

[0252] In general, via a user interface comprised in the selection module 14, a target area X could be determined and weighted by the system 10.

[0253] Not shown in this embodiment is, that the calculation module 16 could translate the at least one target area X selected into a certain weighting, such as a current weighing, on a real electrode array A′ comprising electrodes E related to the system 10 for stimulating a patient.

[0254] In general, the target area X could be alternatively and/or additionally provided as kinematic model M, wherein intended muscles could be determined and weighted and/or unwanted crosstalk between agonists and antagonists could be assigned.

[0255] Not shown in FIG. 7 is that while selecting and/or interacting with target areas, at least one key performance indicator, such as the selectivity index could be provided, in particular as graphical information provided by the graphical presentation module 12.

[0256] In general, it could also be possible that target muscles and/or planed movements are selected, and stimulation is applied according to the selection, cf. FIG. 8.

[0257] FIG. 8 shows a further example of graphical information provided by the graphical presentation module 12, according to the present invention.

[0258] The shown embodiment is a display of a tablet computer, in particular a touch screen.

[0259] However, in general, any touch screen and/or screen and/or mobile device could be possible.

[0260] In this embodiment, the display discloses the graphical information provided by the graphical presentation module 12 of the system 10 disclosed in FIG. 1.

[0261] In this embodiment, the selection module 14 comprises a user interface.

[0262] In this embodiment, the selection module 14 comprises a graphical user interface.

[0263] In this embodiment, the graphical information provided by the graphical presentation module 12 of the system 10 disclosed in FIG. 1 comprises possible target muscles MU to be stimulated, illustrated as different muscles MU of an avatar AV.

[0264] In this embodiment, the graphical information provided by the graphical presentation module 12 of the system 10 disclosed in FIG. 1 further comprises a schema configured and arranged to illustrate a target area X based on target muscles MU.

[0265] In this embodiment, a user can select at least one target muscle MU by selecting at least one muscle MU, e.g. by touching the corresponding muscle MU of the avatar AV with a finger.

[0266] In this embodiment, the user selects the right quadriceps Q.

[0267] In this embodiment, the selection module 14, based on the selected target muscle MU, selects a target area X.

[0268] In this embodiment, the target area X comprises spinal nerves L1-L5.

[0269] Not shown in this embodiment is that a patient is implanted with an electrode array A (electrode array A also shown in FIG. 8) capable of providing stimulation on the target area X.

[0270] In this embodiment, the calculation module 16 determines a contribution of currents provided to the target area X selected in order to stimulate the muscle MU selected.

[0271] In this embodiment, the contribution of currents provided to the target area X gradually decreases from the center to the outside O of the target area X.

[0272] The electrode array A provides stimulation to the target area X via selected electrodes E and selected stimulation parameters.

[0273] In this example, the current is 1.5 mA, the frequency is 1.0000 Hz and the pulse-width is 0.3 ms.

[0274] However, in an alternative embodiment, other stimulation parameters could be generally possible.

[0275] It will be appreciated that the configurations and routines disclosed herein are exemplary in nature, and that these specific embodiments are not to be considered in a limiting sense, because numerous variations are possible. The subject matter of the present disclosure includes all novel and non-obvious combinations and sub-combinations of the various systems and configurations, and other features, functions, and/or properties disclosed herein.

[0276] The following claims particularly point out certain combinations and sub-combinations regarded as novel and non-obvious. Such claims should be understood to include incorporation of one or more such elements, neither requiring nor excluding two or more such elements. Other combinations and sub-combinations of the disclosed features, functions, elements, and/or properties may be claimed through amendment of the present claims or through presentation of new claims in this or a related application. Such claims, whether broader, narrower, equal, or different in scope to the original claims, are also regarded as included within the subject matter of the present disclosure.