Programming interface for spinal cord neuromodulation

• US 8,913,804 B2
• Filed: 06/14/2011
• Issued: 12/16/2014
• Est. Priority Date: 06/14/2010
• 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, Schulte, Gregory T., Kokones, Scott, Carlton, Keith
• Primary Examiner(s): Desire, Gregory M
• Application Number:
  US13/160,104
• Publication Number:
  US 20120014580A1
• Time in Patent Office: 1,281 Days
• Field of Search: 382/128, 382/132, 607/46, 607/117, 607/122, 607/45, 607/116
• US Class Current: 382/128
• CPC Class Codes: A61B 2090/368 changing the image on a display according to the operator's position
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/506 for diagnosis of nerves
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36182 Direction of the electrical field, e.g. with sleeve around stimulating electrode
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 30/20 for handling medical images, e.g. DICOM, HL7 or PACS
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: G16H 70/20 relating to practices or guidelines

Abstract

A tool for assisting in the planning or performing of electrical neuromodulation of a patient'"'"'s spinal cord. The tool may have various functions and capabilities, including calculating a volume of activation, registering an electrode(s) shown in a radiologic image, constructing functional images of the patient'"'"'s spinal anatomy, targeting of neuromodulation, finding a functional midline between multiple electrodes, determining the three-dimensional position of multiple electrodes, and/or accommodating for electrode migration. In certain embodiments, the tool can be embodied as computer software or a computer system.

Claims

1. A computer-implemented method for assisting planning or performing of neuromodulation in a patient, comprising:

storing, by a computer processor, a mapping of each of a plurality of anatomical neuromodulation candidate regions to respective stimulation effect regions that are different than the plurality of anatomical neuromodulation candidate regions;

receiving, by the processor, input by which one of the stimulation effect regions is selected;

responsive to the input, determining, by the processor, one or more electrode neuromodulation settings estimated by the processor to produce a volume of tissue activation that at least partially encompasses a target anatomical neuromodulation candidate region, of the plurality of anatomical candidate regions, which is mapped in the stored mapping to the selected one of the plurality of stimulation effect regions; and

outputting, by the processor, at least one of the one or more electrode neuromodulation settings and a display of the estimated volume of tissue activation.

2. The method of claim 1, further comprising:

storing, by the processor, a position of one or more electrodes relative to the plurality of anatomical neuromodulation candidate regions; and

determining, by the processor and based on the stored position, one or more electric fields producible by the one or more electrodes relative to the plurality of anatomical neuromodulation candidate regions, wherein the estimation of the production of the volume of tissue activation for at least partially encompassing the target anatomical neuromodulation candidate region is based on the determined one or more electric fields.

3. The method of claim 1, further comprising:

obtaining, by the processor, a functional image of the patient'"'"'s anatomy, wherein the functional image includes a representation of the one or more electrodes and a graphical representation of the plurality of anatomical neuromodulation candidate regions; and

registering the position of the one or more electrodes relative to the plurality of anatomical neuromodulation candidate regions based on the functional image.

4. The method of claim 3, wherein the functional image is of the vertebral column.

5. The method of claim 4, wherein the location of the vertebral bodies of the vertebral column is registered in the functional image.

6. The method of claim 5, wherein the functional image includes information that associates one or more of the vertebral bodies in the functional image with a dermatome.

7. The method of claim 3, wherein the functional image includes an x-ray image of the patient'"'"'s spine.

8. The method of claim 1, wherein the plurality of anatomical neuromodulation candidate regions are of the spinal anatomy and the stimulation effect regions are dermatomes.

9. The method of claim 8, wherein:

the input is a selection of a location on the patient'"'"'s body; and

responsive to the input;

the processor associates the location with one of the dermatomes; and

uses the mapping to map the associated dermatome to the target anatomical neuromodulation candidate region.

10. The method of claim 7, wherein the location on the patient'"'"'s body is received as a sensory signal from a sensory nerve.

11. The method of claim 1, further comprising displaying the target anatomical neuromodulation candidate region on the display screen.

12. The method of claim 1, wherein the input identifies a dermatome on the patient'"'"'s body, and the processor responsively determines, based on the mapping and as the target anatomical neuromodulation candidate region, the anatomical neuromodulation candidate region that is associated with the identified dermatome.

13. The method of claim 1, further comprising fine-tuning the one or more electrode neuromodulation settings based on a received electromyographic signal indicating a location of parasthesia being sensed by the patient.

14. The method of claim 1, further comprising:

receiving a radiologic image of the patient showing one or more electrodes inside the patient;

locating the one or more electrodes in the radiologic image, wherein the one or more electrodes collectively include multiple electrode contacts;

determining a functional midline for the one or more electrodes; and

displaying on a display screen, an image of (a) an anatomic region that encompasses the plurality of anatomical neuromodulation candidate regions and (b) the one or more electrodes such that the functional midline of the one or more electrodes is aligned to the physiologic midline of the anatomic region.

15. The method of claim 14, wherein the step of determining the functional midline comprises:

receiving information about the relative electrical neuromodulation intensity between a first electrode contact among the multiple electrode contacts and a first counterpart electrode contact among the multiple electrode contacts; and

based on the relative electrical neuromodulation intensities, determining a first midpoint between the first electrode contact and the first counterpart electrode contact.

16. The method of claim 15, wherein the step of determining the functional midline further comprises:

receiving information about the relative electrical neuromodulation intensity between a second electrode contact among the multiple electrode contacts and a second counterpart electrode contact among the multiple electrode contacts;

based on the relative electrical neuromodulation intensities, determining a second midpoint between the second electrode contact and the second counterpart electrode contact; and

establishing the functional midline as a line between the first midpoint and the second midpoint.

17. The method of claim 15, wherein multiple electrodes are located in the radiologic image;

and wherein the first electrode contact is on a first one of the multiple electrodes and the first counterpart electrode contact is on a second one of the multiple electrodes.

18. The method of claim 17, wherein the step of determining the functional midline further comprises:

receiving information about the relative electrical neuromodulation intensity between a second electrode contact on the first one of the multiple electrodes and a second counterpart electrode contact on the second one of the multiple electrodes;

based on the relative electrical neuromodulation intensities, determining a second midpoint between the second electrode contact and the second counterpart electrode contact; and

establishing the functional midline as a line between the first midpoint and the second midpoint.

19. The method of claim 17, further comprising determining the relative position of the multiple electrodes in relation to each other.

20. The method of claim 15, wherein the relative electrical neuromodulation intensity between the first electrode contact and the first counterpart electrode contact is an electrode neuromodulation setting that produces a parasthesia that is centered on the patient'"'"'s body.

21. The method of claim 1, further comprising:

receiving a first radiologic image showing an electrode and an anatomic region of the patient that encompasses the plurality of anatomical neuromodulation candidate regions;

receiving a second radiologic image showing the electrode and the anatomic region of the patient, wherein the second radiologic image provides a different view than the first radiologic image; and

using the first radiologic image and the second radiologic image to determine the three-dimensional position of the electrode in relation to the anatomic region, wherein the estimation of the volume of tissue activation relative to the target anatomical neuromodulation candidate region is based on the determined three-dimensional position of the electrode.

22. The method of claim 21, wherein the first radiologic image and second radiologic image show multiple electrodes, and further comprising:

using the first radiologic image and the second radiologic image to determine the three-dimensional position of the multiple electrodes in relation to each other.

23. The method of claim 21, wherein the first radiologic image and second radiologic image are x-ray images.

24. The method of claim 23, wherein the first radiologic image is an anterior-posterior view x-ray image and the second radiologic image is a lateral view x-ray image.

25. The method of claim 1, wherein the neuromodulation is spinal cord neuromodulation, and the functional regions are of the patient'"'"'s spinal anatomy.

26. The method of claim 1, further comprising:

receiving information about the relative electrical neuromodulation intensity between a first electrode contact of a first electrode and a first counterpart electrode contact of a second electrode;

based on the relative electrical neuromodulation intensities, determining a first midpoint between the first electrode contact and the first counterpart electrode contact;

receiving information about the relative electrical neuromodulation intensity between a second electrode contact of the first electrode and a second counterpart electrode contact of the second electrode;

based on the relative electrical neuromodulation intensities, determining a second midpoint between the second electrode contact and the second counterpart electrode contact;

establishing a functional midline as a line between the first midpoint and the second midpoint;

wherein the input includes user input indicating a side of the patient'"'"'s spinal cord, and the determination of the one or more neuromodulation settings is of settings estimated by the processor to produce the volume of activation at a side of the functional midline that corresponds to the side of the patient'"'"'s spinal cord indicated by the received user input.

27. The method of claim 1, further comprising:

outputting a user interface display of an anatomical atlas, wherein the input is user user input, the user input being performed by user selection of a location in the displayed anatomical atlas.

28. A computer system comprising:

a computer processor that is programmed to perform steps that comprise;

providing a functional image of the patient'"'"'s anatomy, wherein the functional image of the anatomy includes an electrode and information defining functional regions of the anatomy according to one or more neurologic functions;

determining the position of the electrode relative to the functional regions;

based on the one or more neurologic functions, selecting one of the defined functional regions as a target functional region of the anatomy;

providing an electric field model of the electrode based on its determined relative position; and

determining, based on the electric field model, one or more electrode neuromodulation settings that produces a volume of activation that is estimated to at least partially encompass the targeted functional region of the anatomy.

29. The computer system of claim 28, further comprising:

receiving a first radiologic image showing the electrode and an anatomic region of the patient that encompasses the functional regions;

receiving a second radiologic image showing the electrode and the anatomic region of the patient, wherein the second radiologic image provides a different view than the first radiologic image; and

using the first radiologic image and the second radiologic image to determine the three-dimensional position of the electrode in relation to the anatomic region, wherein the volume of activation is estimated by the system based on the determined three-dimensional position.

30. The system of claim 28, wherein the functional image is of the patient'"'"'s spinal anatomy and includes information defining functional regions of the spinal anatomy.

31. A non-transitory computer-readable storage medium comprising instructions executable by a computer processor, the instructions which, when executed by the processor, cause the processor to perform a method, the method comprising:

providing a functional image of the patient'"'"'s anatomy, wherein the functional image of the anatomy includes one or more electrodes and information defining functional regions of the anatomy according to one or more neurologic functions;

determining the position of the one or more electrodes relative to the functional regions;

based on the one or more neurologic functions, selecting one of the defined functional regions as a target functional region of the anatomy;

providing an electric field model of the one or more electrodes based on its determined relative position; and

determining, based on the electric field model, one or more electrode neuromodulation settings that produces a volume of activation that is estimated to at least partially encompass the targeted functional region of the anatomy.

32. The non-transitory computer-readable storage medium of claim 31, further comprising:

locating the one or more electrodes in the radiologic image, wherein the one or more electrodes collectively include multiple electrode contacts; and

determining a functional midline for the one or more electrodes.

33. The non-transitory computer-readable storage medium of claim 31, wherein the method further comprises:

receiving a first radiologic image showing the electrode and an anatomic region of the patient that encompasses the functional regions;

receiving a second radiologic image showing the electrode and the anatomic region of the patient, wherein the second radiologic image provides a different view than the first radiologic image; and

using the first radiologic image and the second radiologic image to determine the three-dimensional position of the electrode in relation to the anatomic region, wherein the volume of activation is estimated by the processor based on the determined three-dimensional position.

34. The non-transitory computer-readable storage medium method of claim 33, wherein the anatomic region is a spinal anatomy of the patient.

35. The system of claim 31, wherein the functional image is of the patient'"'"'s spinal anatomy and includes information defining functional regions of the spinal anatomy.

36. A computer-implemented method for assisting the planning or performing of neuromodulation in a patient, comprising:

receiving, by a computer processor, a first radiologic image of an electrode inside a patient, wherein the electrode is in a first position;

receiving, by the processor, a second radiologic image of the electrode after a change in the position of the electrode, wherein the electrode is in a second position;

determining, by the processor and based on the received first and second images, the position of the electrode in the second position relative to the electrode in the first position;

calculating, by the processor, a first volume of activation estimated to be generated by the electrode in the first position;

determining, by the processor, an electrode neuromodulation setting for the electrode in the second position estimated by the processor to produce a second volume of activation that at least partially encompasses the first volume of activation; and

displaying, by the processor, the second volume of activation on a display screen.

37. The method of claim 36, further comprising:

calculating multiple test volumes of activation using different electrode neuromodulation settings;

comparing the multiple test volumes of activation to the first volume of activation; and

based on the comparison of the multiple test volumes of activation, selecting an electrode neuromodulation setting for the electrode in the second position that produces the second volume of activation.

38. The method of claim 37, wherein the step of comparing the multiple test volumes of activation to the first volume of activation includes calculating a score for each test volume of activation, the score comprising the amount of test volume of activation that overlaps with the first volume of activation.

39. The method of claim 36, further comprising displaying the first volume of activation on the display screen.

40. The method of claim 36, wherein the neuromodulation is spinal cord neuromodulation.

41. A computer system that is programmed to perform steps that comprise:

receiving a first radiologic image of one or more electrodes inside a patient, wherein the one or more electrodes is in a first position;

receiving a second radiologic image of the one or more electrodes after a change in the position of at least one of the one or more electrodes, wherein the one or more electrodes is in a second position;

determining the position of the one or more electrodes in the second position relative to the one or more electrodes in the first position;

calculating a first volume of activation generated by the one or more electrodes in the first position; and

determining an electrode neuromodulation setting for the one or more electrodes in the second position that produces a second volume of activation that at least partially encompasses the first volume of activation.

42. The system of claim 41, wherein the one or more electrodes collectively include multiple electrode contacts, and the method further comprises determining a functional midline for the one or more electrodes.

43. A non-transitory computer-readable storage medium comprising instructions executable by a computer processor, the instructions which, when executed by the processor, cause the processor to perform a method, the method comprising:

receiving a first radiologic image of an electrode inside a patient, wherein the electrode is in a first position;

receiving a second radiologic image of the electrode after a change in the position of the electrode, wherein the electrode is in a second position;

determining, based on the received first and second images, the position of the electrode in the second position relative to the electrode in the first position;

calculating a first volume of activation estimated to be generated by the electrode in the first position; and

determining an electrode neuromodulation setting for the electrode in the second position estimated by the processor to produce a second volume of activation that at least partially encompasses the first volume of activation.

44. A computer-implemented method for assisting the planning or performing of spinal cord neuromodulation in a patient, comprising:

determining, by a computer processor, at least one of (a) a thickness of cerebrospinal fluid at a location at which it separates a spinal cord from an electrode positioned adjacent the spinal cord and (b) a depth of the cerebrospinal fluid at which the cerebrospinal fluid separates the spinal cord from the electrode;

calculating, by the computer processor, a volume of activation estimated to be created, under a set of electrode neuromodulation conditions, by the electrode positioned adjacent the spinal cord, wherein;

the calculation is based on an electric field model of the electrode;

the model is based on a characteristic of the cerebrospinal fluid between the electrode and the spinal cord; and

a degree to which the characteristic of the cerebrospinal fluid affects the model used by the processor for calculating the volume of activation varies depending on the determined at least one of the thickness and depth of the cerebrospinal fluid that separates the electrode from the spinal cord; and

displaying the predicted volume of activation on a display screen.

45. The method of claim 44, wherein:

the method includes the step of determining the depth of the cerebrospinal fluid between the electrode and the spinal cord; and

the method further comprises registering the depth of the cerebrospinal fluid in the electric field model.

46. The method of claim 45, wherein:

the step of determining the depth of the cerebrospinal fluid comprises receiving and processing a radiologic image of the patient showing the spinal cord and the electrode;

the method further comprises calculating the thickness of the cerebrospinal fluid between the spinal cord and the electrode based on the determined depth; and

the electric field model is customized to the calculated thickness.

47. The method of claim 46, wherein the radiologic image is an MR image of the patient'"'"'s spine.

48. The method of claim 46, wherein the calculation of the thickness of the cerebrospinal fluid comprises using information about the position of the electrode.

49. The method of claim 48, wherein the information about the position of the electrode includes the vertebral level where the electrode is positioned and the thickness of the cerebrospinal fluid is approximated by the vertebral level or the vertebrae size where the electrode is positioned.

50. The method of claim 49, wherein:

the radiologic image shows the electrode and the patient'"'"'s vertebrae; and

the method further includes;

locating the electrode within the radiologic image; and

determining the vertebral level where the electrode is positioned.

51. A computer system that is programmed to perform steps that comprise:

determining at least one of (a) a thickness of cerebrospinal fluid at a location at which it separates a spinal cord from an electrode positioned adjacent the spinal cord and (b) a depth of the cerebrospinal fluid at which the cerebrospinal fluid separates the spinal cord from the electrode;

providing an electric field model of the electrode positioned adjacent the spinal cord, wherein the model is based on a characteristic of the cerebrospinal fluid; and

using the electric field model to calculate a volume of activation estimated to be created by the electrode under a set of electrode neuromodulation conditions, wherein a degree to which the characteristic of the cerebrospinal fluid affects the model used for the calculation of the volume of activation varies depending on the determined at least one of the thickness and depth of the cerebrospinal fluid that separates the electrode from the spinal cord.

52. A non-transitory computer-readable storage medium comprising instructions executable by a computer processor, the instructions which, when executed by the processor, cause the processor to perform a method, the method comprising:

determining at least one of (a) a thickness of cerebrospinal fluid at a location at which it separates a spinal cord from an electrode positioned adjacent the spinal cord and (b) a depth of the cerebrospinal fluid at which the cerebrospinal fluid separates the spinal cord from the electrode;

providing an electric field model of the electrode positioned adjacent the spinal cord, wherein the model is based on a characteristic of the cerebrospinal fluid; and

using the electric field model to calculate a volume of activation estimated to be created by the electrode under a set of electrode neuromodulation conditions, wherein a degree to which the characteristic of the cerebrospinal fluid affects the model used for the calculation of the volume of activation varies depending on the determined at least one of the thickness and depth of the cerebrospinal fluid that separates the electrode from the spinal cord.