System and method for determining target stimulation volumes

• US 10,342,972 B2
• Filed: 04/11/2016
• Issued: 07/09/2019
• Est. Priority Date: 03/29/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Blum, David Arthur, Kokones, Scott, Moffitt, Michael A., Barnhorst, Jordan, Carlton, Keith
• Primary Examiner(s): Patel, Niketa I
• Assistant Examiner(s): Pham, Minh Duc G
• Application Number:
  US15/095,536
• Publication Number:
  US 20160225152A1
• Time in Patent Office: 1,184 Days
• Field of Search: 607 45
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: F04C 2270/041 Controlled or regulated
• CPC Class Codes: G06F 18/22 Matching criteria, e.g. proximity measures
• CPC Class Codes: G06F 3/04815 Interaction with a metaphor-based environment or interaction object displayed as three-dimensional, e.g. changing the user viewpoint with respect to the environment or object
• CPC Class Codes: G06F 3/04845 for image manipulation, e.g. dragging, rotation, expansion or change of colour
• CPC Class Codes: G06T 11/003 Reconstruction from projections, e.g. tomography
• CPC Class Codes: G06T 11/60 Editing figures and text; Combining figures or text
• CPC Class Codes: G06T 15/005 General purpose rendering architectures
• CPC Class Codes: G06T 15/08 Volume rendering
• CPC Class Codes: G06T 19/00 Manipulating 3D models or images for computer graphics
• CPC Class Codes: G06T 19/003 Navigation within 3D models or images
• CPC Class Codes: G06T 2200/04 involving 3D image data
• CPC Class Codes: G06T 2200/24 involving graphical user interfaces [GUIs]
• CPC Class Codes: G06T 2207/10064 Fluorescence image
• CPC Class Codes: G06T 2207/10072 Tomographic images
• CPC Class Codes: G06T 2207/10081 Computed x-ray tomography [CT]
• CPC Class Codes: G06T 2207/10088 Magnetic resonance imaging [MRI]
• CPC Class Codes: G06T 2207/10092 Diffusion tensor magnetic resonance imaging [DTI]
• CPC Class Codes: G06T 2207/30016 : Brain
• CPC Class Codes: G06T 2219/028 : Multiple view windows (top-side-front-sagittal-orthogonal)
• CPC Class Codes: G06T 3/40 : Scaling of whole images or parts thereof, e.g. expanding or contracting
• CPC Class Codes: G06T 3/4038 : Image mosaicing, e.g. composing plane images from plane sub-images
• CPC Class Codes: G06T 7/0012 : Biomedical image inspection
• CPC Class Codes: G06T 7/30 : Determination of transform parameters for the alignment of images, i.e. image registration
• CPC Class Codes: G06T 7/33 : using feature-based methods
• CPC Class Codes: G06T 7/38 : Registration of image sequences
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 30/20 : for handling medical images, e.g. DICOM, HL7 or PACS
• CPC Class Codes: G16H 30/40 : for processing medical images, e.g. editing

Abstract

A system and method may include determining a target stimulation volume based on modifying a patient population image for which an efficacious volume had been determined. A system and method for suggesting stimulation devices may include determining which stimulation device is capable of producing an output volume of activation that most closely matches the target volume. A system and method for facilitating selection of stimulation parameters may include graphically identifying a maximum volume in which tissue is stimulatable by an implanted stimulation device. A system and method may pre-compute volumes of activation that result from a predetermined modification of programming settings. A system and method may transmit stimulation programming settings from a stimulation programming module to a stimulation generating device.

Claims

1. A system of selecting a stimulation device combination, comprising:

a computer processor configured to;

receive information pertaining to a position for implantation of each of a plurality of stimulation devices within an anatomical region of a subject patient, wherein each of the stimulation devices comprises a leadwire comprising i) at least one set of multiple electrodes disposed around a perimeter of the leadwire at a same longitudinal level of the leadwire and ii) a non-electrode marker disposed at a different level of the leadwire and formed of a same material as the electrodes and arranged on the leadwire so that a rotational position of the non-electrode marker coincides with a rotational position of one of the electrodes of at least one of the at least one set, wherein, for each of the stimulation devices, the information pertaining to a position for implantation of each of a plurality of stimulation devices comprises at least one axial CT slice of the leadwire at the level of the non-electrode marker and at least one axial CT slice of the leadwire at a level of one of the at least one set of multiple electrodes, wherein the axial CT slices indicate a rotational orientation of the leadwire;

receive information pertaining to a target volume of activation;

determine, by the computer processor and based on the positions for implantation of the plurality of stimulation devices, which of the plurality of stimulation devices is capable of producing an output volume of activation that, compared to volumes of activation producible by others of the plurality of stimulation devices, most closely matches the target volume of activation when in the position;

output an identification of the determined stimulation device and the corresponding position for implantation;

receive a set of stimulation programming settings;

determine, based on the set of stimulation programming settings, an output volume of activation for the determined stimulation device;

display, on a display, the output volume of activation; and

transmit the set of stimulation programming settings to an implantable pulse generator coupled to the leadwire to produce electrical stimulation according to the set of stimulation programming settings.

2. The system of claim 1, wherein the processor performs the determining by:

calculating a set of stimulation signals that produces the most closely matching volume of activation; and

determining which of the plurality of stimulation devices is capable of producing the calculated set of stimulation signals.

3. The system of claim 1, wherein the processor is further configured to:

determine which of a plurality of implantable pulse generators is best suited for a source of stimulation pulses for producing the most closely matching volume of activation; and

output an identification of the determined implantable pulse generator.

4. The system of claim 3, wherein the best suited implantable pulse generator is an implantable pulse generator that produces lowest overall driving levels for producing the most closely matching volume of activation, compared to others of the plurality of implantable pulse generators.

5. The system of claim 3, wherein the best suited implantable pulse generator is an implantable pulse generator that produces a lowest number of different driving levels for producing the most closely matching volume of activation compared to others of the plurality of implantable pulse generators.

6. The system of claim 1, wherein the information pertaining to a position for implantation indicates a trajectory to the anatomical region.

7. The system of claim 1, wherein receiving information pertaining to a target volume of activation comprises receiving the target volume of activation from a user.

8. The system of claim 1, wherein receiving information pertaining to a target volume of activation comprises receiving a patient condition and information regarding effective volumes of activation in a patient population and determining the target volume of activation from the patient condition and the information regarding effective volumes of activation in a patient population.

9. The system of claim 1, wherein determining which of the plurality of stimulation devices is capable of producing an output volume of activation comprises determining a depth of implantation of the determined stimulation device.

10. The system of claim 1, wherein the processor is further configured to graphically identify, on a display, a maximum volume in which tissue is stimulatable by the determined stimulation device.

11. The system of claim 10, wherein the processor is further configured to:

receive a maximum stimulation amplitude; and

determine the maximum volume from the maximum stimulation amplitude.

12. The system of claim 10, wherein the maximum volume is graphically identified, on the display, by removing from an image of an anatomical region all image data corresponding to anatomical regions that extend beyond the maximum volume, and displaying the modified image.

13. The system of claim 10, wherein the maximum volume is graphically identified, on the display, by displaying a region corresponding to anatomical regions that extend beyond the maximum volume at a different brightness than a region corresponding to anatomical regions that are within the maximum volume.

14. The system of claim 10, wherein the processor is further configured to:

display, on the display, the output volume of activation together with the maximum volume.

15. The system of claim 14, wherein the processor is further configured to:

differently display, on the display, regions of the output volume of activation that are within the maximum volume and regions of the output volume of activation that are external to the maximum volume.

16. A computer-implemented method for selecting a stimulation device combination, the method comprising:

receiving information pertaining to a position for implantation of each of a plurality of stimulation devices within an anatomical region of a subject patient, wherein each of the stimulation devices comprises a leadwire comprising i) at least one set of multiple electrodes disposed around a perimeter of the leadwire at a same longitudinal level of the leadwire and ii) a non-electrode marker disposed at a different level of the leadwire and formed of a same material as the electrodes and arranged on the leadwire so that a rotational position of the non-electrode marker coincides with a rotational position of one of the electrodes of at least one of the at least one set, wherein, for each of the stimulation devices, the information pertaining to a position for implantation of each of a plurality of stimulation devices comprises at least one axial CT slice of the leadwire at the level of the non-electrode marker and at least one axial CT slice of the leadwire at a level of one of the at least one set of multiple electrodes, wherein the axial CT slices indicate a rotational orientation of the leadwire;

receiving information pertaining to a target volume of activation;

determining, by a computer processor and based on the positions for implantation of the plurality of stimulation devices, which of the plurality of stimulation devices is capable of producing an output volume of activation that, compared to volumes of activation producible by others of the plurality of stimulation devices, most closely matches the target volume of activation when in the position;

outputting an identification of the determined stimulation device and the corresponding position for implantation;

receiving a set of stimulation programming settings;

determining, based on the set of stimulation programming settings, an output volume of activation for the determined stimulation device;

displaying, on a display, the output volume of activation; and

transmitting the set of stimulation programming settings to an implantable pulse generator coupled to the leadwire to produce electrical stimulation according to the set of stimulation programming settings.

17. A non-transitory computer-readable storage medium having instructions stored thereon and executable by a processor for selecting a stimulation device combination, the instructions comprising:

receiving information pertaining to a position for implantation of each of a plurality of stimulation devices within an anatomical region of a subject patient, wherein each of the stimulation devices comprises a leadwire comprising i) at least one set of multiple electrodes disposed around a perimeter of the leadwire at a same longitudinal level of the leadwire and ii) a non-electrode marker disposed at a different level of the leadwire end formed of a same material as the electrodes and arranged on the leadwire so that a rotational position of the non-electrode marker coincides with a rotational position of one of the electrodes of at least one of the at least one set, wherein, for each of the stimulation devices, the information pertaining to a position for implantation of each of a plurality of stimulation devices comprises at least one axial CT slice of the leadwire at the level of the non-electrode marker and at least one axial CT slice of the leadwire at a level of one of the at least one set of multiple electrodes, wherein the axial CT slices indicate a rotational orientation of the leadwire;

receiving information pertaining to a target volume of activation;

determining, based on the positions for implantation of the plurality of stimulation devices, which of the plurality of stimulation devices is capable of producing an output volume of activation that, compared to volumes of activation producible by others of the plurality of stimulation devices, most closely matches the target volume of activation when in the position;

outputting an identification of the determined stimulation device and the corresponding position for implantation;

receiving a set of stimulation programming settings;

determining, based on the set of stimulation programming settings, an output volume of activation for the determined stimulation device;

displaying, on a display, the output volume of activation; and

transmitting the set of stimulation programming settings to an implantable pulse generator coupled to the leadwire to produce electrical stimulation according to the set of stimulation programming settings.

18. The computer-readable storage medium of claim 17, wherein determining which of the plurality of stimulation devices is capable of producing an output volume of activation comprises:

calculating a set of stimulation signals that produces the most closely matching volume of activation; and

determining which of the plurality of stimulation devices is capable of producing the calculated set of stimulation signals.

19. The computer-readable storage medium of claim 17, wherein the instructions further comprise:

determining which of a plurality of implantable pulse generators is best suited for a source of stimulation pulses for producing the most closely matching volume of activation; and

outputting an identification of the determined implantable pulse generator.

20. The computer-readable storage medium of claim 17, wherein the information pertaining to a position for implantation indicates a trajectory to the anatomical region.