US-12616524-B2 - Image-guided navigation system for targeted delivery of spinal cord therapies

Abstract

Image-guided navigation for spinal cord treatments and therapies are described. The image-guided navigation is augmented with anatomical measurement data related to spinal cord and vertebral anatomy. From these data and medical image data, an augmented model of spinal cord anatomy is generated and/or navigation data can be generated for localizing spinal cord structures, such as by mapping the anatomical measurement data to the medical image data. The augmented model data and/or navigation data can be used for surgical navigation, stimulation parameter setting, electrode configuration selection, pre-surgical planning, surgical visualization, and so on.

Inventors

• Igor A. Lavrov
• Riazul Islam
• Nirusha Lachman
• Alan Mendez Ruiz

Assignees

• MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH

Dates

Publication Date

20260505

Application Date

20201019

Claims (20)

1. 1 . A method for providing navigation to an anatomical region of a spinal cord, the method comprising: (a) accessing anatomical measurement data with a computer system, the anatomical measurement data including at least one of quantitative dimensions of spinal cord anatomy structures and quantitative dimensions between spinal cord anatomy structures; (b) accessing medical image data with the computer system, wherein the medical image data were obtained from a subject and depict at least a spinal cord of the subject and one or more vertebrae of the subject, wherein the one or more vertebrae comprise bony landmarks visible in the medical image data; (c) generating navigation data from the anatomical measurement data and the medical image data using the computer system to map the anatomical measurement data to the medical image data relative to the one or more vertebrae depicted in the medical image data by correlating the anatomical measurement data with the bony landmarks visible in the medical image data to establish spatial relationships between the anatomical measurement data and the vertebrae depicted in the medical image data, wherein the navigation data provide navigation to an anatomical region of the spinal cord by mapping the quantitative dimensions of spinal cord anatomy structures and quantitative dimensions between spinal cord anatomy structures with respect to the one or more vertebrae of the subject, wherein the navigation data comprise spatial location information that indicates positions of spinal cord structures relative to the one or more vertebrae to enable localization of the anatomical region; and (d) displaying the navigation data to a user in order to provide navigation to the anatomical region.
2. 2 . The method of claim 1 , wherein the navigation data comprise coordinate data for a surgical navigation system.
3. 3 . The method of claim 2 , wherein the navigation data indicate one or more spatial locations for positioning an electrode for providing electrical stimulation to the spinal cord of the subject.
4. 4 . The method of claim 1 , wherein the navigation data indicate spatial locations of spinal cord structures relative to the one or more vertebrae depicted in the medical image data.
5. 5 . The method of claim 1 , wherein the navigation data providing navigation to the anatomical region comprises at least one of a spinal cord segment target, a spinal cord midline target, a spinal cord lateral target, a dorsal column target, a dorsal horn target, a dorsal root entry zone target, an inter-dorsal root entry zone target, and a dorsal rootlet target.
6. 6 . The method of claim 1 , wherein displaying the navigation data to a user provides navigation of a spinal cord stimulation lead to the anatomical region.
7. 7 . The method of claim 1 , further comprising generating presurgical planning data with the computer system using the navigation data.
8. 8 . The method of claim 1 , wherein the anatomical measurement data comprise measurements associated with at least one of dorsal roots or ventral roots.
9. 9 . The method of claim 8 , wherein the anatomical measurement data comprise at least one of rostral rootlet angle data, caudal rootlet angle data, a number of rootlets, a width across one or more spinal cord columns, or root diameter.
10. 10 . The method of claim 1 , wherein the anatomical measurement data comprise measurements associated with one or more spinal cord structures.
11. 11 . The method of claim 10 , wherein the anatomical measurement data comprise at least one of transverse diameter, rostral rootlet to caudal rootlet length, segment length at dorsal column, segment length at bone entry, inferior articular facet to caudal rootlet distance, intervertebral foramen to rostral rootlet distance, or intervertebral foramen to caudal rootlet distance.
12. 12 . The method of claim 1 , wherein the anatomical measurement data comprise measurements associated with vertebral bones.
13. 13 . The method of claim 12 , wherein the anatomical measurement data comprise at least one of mid-vertebral foramen length, vertebral bone length, intervertebral foramen distance, or intervertebral foramen diameter.
14. 14 . A method for generating augmented spinal cord anatomy model data, the method comprising: (a) accessing anatomical measurement data with a computer system, the anatomical measurement data including at least one of quantitative dimensions of spinal cord anatomy structures and quantitative dimensions between spinal cord anatomy structures; (b) accessing medical image data obtained from a subject with the computer system, wherein the medical image data depict at least a spinal cord of the subject and one or more vertebrae of the subject, wherein the one or more vertebrae comprise bony landmarks visible in the medical image data; and (c) generating augmented spinal cord anatomy model data with the computer system by mapping the quantitative dimensions of spinal cord anatomy structures and quantitative dimensions between spinal cord anatomy structures based on the anatomical measurement data to the one or more vertebrae based on the medical image data by establishing correlations between the anatomical measurement data and the bony landmarks identified in the medical image data to create spatial associations between the quantitative dimensions and the bony landmarks.
15. 15 . The method of claim 14 , wherein the medical image data comprise images acquired with multiple different imaging modalities.
16. 16 . The method of claim 15 , wherein the multiple different imaging modalities include at least two of magnetic resonance imaging (MRI), x-ray imaging, fluoroscopic imaging, computed tomography, positron emission tomography (PET), single-photon emission computed tomography (SPECT), and ultrasound imaging.
17. 17 . The method of claim 14 , wherein the anatomical measurement data comprise measurements associated with at least one of dorsal roots or ventral roots.
18. 18 . The method of claim 17 , wherein the anatomical measurement data comprise at least one of rostral rootlet angle data, caudal rootlet angle data, a number of rootlets, a width across one or more spinal cord columns, or root diameter.
19. 19 . The method of claim 14 , wherein the anatomical measurement data comprise measurements associated with one or more spinal cord structures.
20. 20 . The method of claim 19 , wherein the anatomical measurement data comprise at least one of transverse diameter, rostral rootlet to caudal rootlet length, segment length at dorsal column, segment length at bone entry, inferior articular facet to caudal rootlet distance, intervertebral foramen to rostral rootlet distance, or intervertebral foramen to caudal rootlet distance.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application represents the national stage entry of PCT/US2020/056319 filed on Oct. 19, 2020 and claims the benefit of U.S. Provisional Patent Application Ser. No. 62/916,640, filed on Oct. 17, 2019, and entitled “IMAGE-GUIDED AUGMENTED HYBRID NAVIGATION SYSTEM FOR TARGETED DELIVERY OF SPINAL CORD THERAPIES,” the contents of which is herein incorporated by reference in its entirety. BACKGROUND The understanding of spinal cord functional neuroanatomy is important for diagnosis, treatment, and management of multiple neurosurgical and neurological disorders, including chronic pain, movement disorders, and spinal cord injury. Currently, little to no information is available on segment-specific spinal cord structures, spinal roots orientation and other spinal cord structures or measurements. In addition, due to the thickness of the dura, these structures cannot be directly visualized with conventional imaging techniques; therefore, these structures are infeasible to target using these conventional imaging technologies. Spinal cord stimulation (“SCS”) including, epidural stimulation, dorsal column, spinal rootlet, and dorsal root ganglion (“DRG”) stimulation are adjustable and effective non-opioid analgesic solutions with demonstrated efficacy. However, the delivery of SCS therapy is not evidence-driven due to the fact that surgeons and physicians do not have access to spinal cord anatomy, due to the limitation of current imaging methods available in the clinic, which cannot accurately image the spinal cord and its detailed anatomy. Previous attempts at imaging spinal cord anatomy have focused on diffusion tensor imaging (“DTI”) and combinations with other imaging methods; however, DTI scans are resource intensive and require longer scan times. In general, DTI is also not part of current clinical SCS pre-surgical assessments, which make its use not feasible for routine SCS applications. SUMMARY OF THE DISCLOSURE The present disclosure addresses the aforementioned drawbacks by providing a method for providing navigation to an anatomical region of a spinal cord. Anatomical measurement data are accessed with a computer system, where the anatomical measurement data indicate quantitative measurements of spinal cord anatomy. Medical image data are also accessed with the computer system, where the medical image data were obtained from a subject and depict at least a spinal cord of the subject and one or more vertebrae of the subject. Navigation data are generated from the anatomical measurement data and the medical image data using the computer system to map the anatomical measurement data to the medical image data relative to the one or more vertebrae depicted in the medical image data. The navigation data provide navigation to an anatomical region of the spinal cord. The navigation data can then be displayed to a user in order to provide navigation to the anatomical region. It is another aspect of the present disclosure to provide a method for generating augmented spinal cord anatomy model data. Anatomical measurement data are accessed with a computer system. These anatomical measurement data indicate quantitative measurements and/or locations of spinal cord anatomy. Medical image data obtained from a subject are also accessed with the computer system. The medical image data depict at least a spinal cord of the subject and one or more vertebrae of the subject. Augmented spinal cord anatomy model data are then generated with the computer system by mapping the anatomical measurement data to the medical image data. The foregoing and other aspects and advantages of the present disclosure will appear from the following description. In the description, reference is made to the accompanying drawings that form a part hereof, and in which there is shown by way of illustration a preferred embodiment. This embodiment does not necessarily represent the full scope of the invention, however, and reference is therefore made to the claims and herein for interpreting the scope of the invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a flowchart setting forth the steps of an example method for generating augmented spinal cord anatomy data, and for using such data in a hybrid image-guided navigation system or other applications. FIG. 2 shows an example diagram of vertebrae (T12-L2) and corresponding spinal cord segments (L2-S2) with array locations based on segment mapping. FIG. 3 shows an example diagram of vertebrae (T10-L5) and corresponding spinal cord segments (T11-S2); dotted lines mark L2 intervertebral foramen to rostral rootlet distance and vertebral bone size. A scatter plot of vertebral bone length versus intervertebral foramen to rostral rootlet distance is also shown. In this plot, Spearman coefficient of correlation value was found to be 0.82 with P<0.001. The equation used to fit the curve was, f=8.5/(1+exp(−(x−2.4)/0.75)). A scatter plot of vertebral bone length versus int