US-12616581-B2 - Methods for restoring bilateral spinal alignment and/or range of motion

Abstract

Disclosed are devices, systems and methods for restoring spinal alignment and/or maximizing range of motion for patients who suffer from spinal degenerative disorders.

Inventors

• Christian Davis
• Marc M. Peterman
• Steven C. Humphreys
• Scott Hodges
• Ron Yarbrough

Assignees

• 3SPINE, INC.

Dates

Publication Date

20260505

Application Date

20230921

Claims (20)

1. 1 . A method of restoring spinal alignment and range of motion comprises the steps of: completing a preoperative imaging protocol to acquire at least one image using one technique to create a first one or more preoperative measurements on a first side and a second one or more preoperative measurements on a second side; selecting a surgical approach; positioning the patient properly; completing an operative imaging protocol to acquire at least one image using one technique to create a first one or more operative measurements on a first side, a second one or more operative measurements on a second side and confirming the first one or more operative measurements on a first side relative to the first one or more preoperative measurements and the second one or more operative measurements on a second side relative to the second one or more preoperative measurements on a second side; accessing at least one localized spine segment in a spine region; selecting a spinal implant size on a first side; preparing a caudal vertebral body on the first side; preparing a cranial vertebral body on the first side; completing a first caudal keel channel on the caudal vertebral body on the first side; and completing a first cranial keel channel on the cranial vertebral body to substantially align with a first toe-in angle of a pedicle of the cranial vertebral body; implanting the selected spinal implant into the first side; selecting a spinal implant size on a second side; preparing an intervertebral space within the at least one localized spine segment in the spine region on the second side; and implanting the selected spinal implant into the second side.
2. 2 . The method of claim 1 , wherein the step of preparing the cranial vertebral body on the first side comprises the step of preparing a portion of an endplate on the first side of the cranial vertebral body to create a first cranial resected or cranial prepared surface.
3. 3 . The method of claim 1 , wherein the step of preparing the cranial vertebral body on the first side further comprises the step of confirming a first alignment of the first cranial resected or prepared surface relative to the first caudal resected surface on the first side.
4. 4 . The method of claim 3 , wherein the confirming the first alignment comprises confirming parallel or substantially parallel alignment of the first cranial prepared or resected surface relative to the first caudal resected surface.
5. 5 . The method of claim 1 wherein the step of completing a first caudal keel channel on the caudal vertebral body on the first side comprises the step of creating the first caudal keel channel extending below the first caudal resected surface on the first side, the first caudal keel channel including a first caudal vertical axis.
6. 6 . The method of claim 1 , wherein the step of completing a first cranial keel channel on the cranial vertebral body on the first side comprises the step of creating the first cranial keel channel above the first cranial resected or prepared surface of the cranial vertebral body that aligns with the first caudal keel channel, the first cranial keel channel including a first cranial keel channel vertical axis.
7. 7 . The method of claim 1 , wherein the preoperative imaging protocol comprises one or more static and dynamic patient positions.
8. 8 . The method of claim 1 , wherein the first one or more preoperative measurements comprises a first angle of correction and/or first center of rotation and the second one or more preoperative measurements comprises a second angle of correction and a second center of rotation.
9. 9 . The method of claim 8 , wherein the first angle of correction comprises a first sagittal angle and/or a first coronal angle and the second angle of correction comprises a second sagittal angle and/or a second coronal angle.
10. 10 . The method of claim 9 , wherein the first angle of correction comprises a different angle than the second angle of correction.
11. 11 . A method of restoring spinal alignment and range of motion comprises the steps of: completing a preoperative imaging protocol to acquire at least one image using one technique to create a first one or more preoperative measurements on a first side and a second one or more preoperative measurements on a second side; selecting a surgical approach; positioning the patient properly; completing an operative imaging protocol to acquire at least one image using one technique to create a first one or more operative measurements on a first side, a second one or more operative measurements on a second side and confirming the first one or more operative measurements on a first side relative to the first one or more preoperative measurements and the second one or more operative measurements on a second side relative to the second one or more preoperative measurements on a second side; accessing at least one localized spine segment in a spine region; selecting a spinal implant size on a first side; preparing an intervertebral space within the at least one localized spine segment in the spine region on the first side; implanting the selected spinal implant into the first side; selecting a spinal implant size on a second side; preparing a caudal vertebral body on the second side; preparing a cranial vertebral body on the second side; completing a caudal keel channel on the caudal vertebral body on the second side; completing a cranial keel channel on the cranial vertebral body to substantially align with a second toe-in angle of a second pedicle of the cranial vertebral body; and implanting the selected spinal implant into the second side.
12. 12 . The method of claim 11 , wherein the step of preparing the intervertebral space within the at least one localized spine segment in the spine region on the first side comprises the step of preparing a portion of an endplate and a portion of a pedicle on the first side of the caudal vertebral body to create a first caudal resected surface.
13. 13 . The method of claim 12 , wherein the first caudal resected surface comprises a first sagittal angle, the first sagittal angle matches or substantially matches a first angle of correction obtained from the first one or more preoperative measurements.
14. 14 . The method of claim 11 , wherein the step of preparing the caudal vertebral body on the second side comprises the step of preparing a portion of an endplate and a portion of a pedicle on the second side of the caudal vertebral body to create a second caudal resected surface.
15. 15 . The method of claim 14 , wherein the second caudal resected surface comprises a second sagittal angle, the second sagittal angle matches or substantially matches a second angle of correction obtained from the second one or more preoperative measurements.
16. 16 . The method of claim 11 , wherein the step of preparing the cranial vertebral body on the second side comprises the step of preparing a portion of an endplate on the second side of the cranial vertebral body to create a second cranial resected or cranial prepared surface.
17. 17 . The method of claim 11 , wherein the step of preparing the cranial vertebral body on the second side further comprises the step of confirming a second alignment of the second cranial resected or prepared surface relative to the second caudal resected surface on the second side.
18. 18 . The method of claim 17 , wherein the confirming the second alignment comprises confirming parallel or substantially parallel alignment of the second cranial prepared or resected surface relative to the second caudal resected surface.
19. 19 . The method of claim 11 , wherein the step of completing a second caudal keel channel on the caudal vertebral body on the second side comprises the step of creating the second caudal keel channel extending below the second caudal resected surface on the second side, the second caudal keel channel including a second caudal vertical axis.
20. 20 . The method of claim 11 , wherein the step of completing a second cranial keel channel on the cranial vertebral body on the second side comprises the step of creating a second cranial keel channel above the second cranial resected or prepared surface of the cranial vertebral body that aligns with the second caudal keel channel, the second cranial keel channel including a second cranial keel channel vertical axis.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of PCT Application No. PCT/US23/23600 entitled “Total Spinal Joint Replacement Methods & Instrumentation,” filed May 25, 2023, which claims the benefit of U.S. Provisional Application No. 63/345,560 entitled “Total Spinal Joint Replacement Methods & Instrumentation,” filed May 25, 2022, U.S. Provisional Application No. 63/375,379 entitled “Surgical Instrumentation for Total Spinal Joint Replacement,” filed Sep. 12, 2022, U.S. Provisional Application No. 63/445,954 entitled “Fusion Spinal Implant Systems,” filed Feb. 15, 2023, and U.S. Provisional Application No. 63/351,568 entitled “Robotic & Navigation Assisted Total Spinal Joint Methods,” filed Jun. 13, 2022, the disclosures of which are incorporated by reference herein in their entireties This application further claims the benefit of and priority to Patent Cooperation Treaty Application No. PCT/US22/74635, entitled “Robotic & Navigation Assisted Total Spinal Joint Methods,” filed Aug. 5, 2022, the disclosure of which is incorporated by reference herein in its entirety. TECHNICAL FIELD The disclosure relates to the field of medical devices for restoration of spinal alignment and maximize range of motion for patients who suffer from spinal degenerative disorders. More specifically, the disclosure further relates to instruments that are configurable for use with a patient in a surgical environment and a method for restoring spinal alignment and range of motion. BACKGROUND OF THE INVENTION Spinal pathologies and disorders such as degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor, and/or fractures may result from a wife variety of factors, including (but not limited to) trauma, disease and/or degenerative conditions often exacerbated by injury and aging. Spinal disorders typically result in symptoms including deformity, pain, nerve damage, and partial or complete loss of mobility that may be treated with surgical and non-surgical options. Non-surgical treatments, such as medication, rehabilitation and exercise can be effective, however, many of these treatments ultimately fail to relieve the symptoms associated with these disorders. Surgical options for these spinal disorders may entail methods, devices and techniques for implanting prosthetics that seek to restore the mechanical support function of vertebrae, but such devices are often unsuccessful in restoring alignment and/or range of motion to the patient's anatomy. Thus, improvements in surgical procedures for addressing spinal injuries and/or pathologies is needed, including devices, methods and techniques for restoring alignment and/or range of motion to a patient's spine. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS FIG. 1 graphically illustrates one embodiment of a preoperative method for a total joint replacement spinal implant system; FIG. 2A graphically illustrates one embodiment of an imaging protocol of FIG. 1; FIG. 2B depicts one embodiment of different static and/or dynamic patient positions for the imaging protocol; FIGS. 3A-3B graphically illustrates different embodiments of an intraoperative method for a total joint spinal implant system; FIGS. 4A-4B depicts different views of available surgical approaches for deployment a total joint replacement spinal implant system; FIG. 5 graphically illustrates one least one embodiment for a method of accessing the localized spine segment in a spine region; FIGS. 6A-6B graphically illustrates different embodiments for one or more decompression techniques for the total joint replacement spinal implant system; FIGS. 7A-7B graphically illustrates one embodiment for a method of selecting the proper spinal implant size; FIGS. 8A-8D graphically illustrates different embodiments of a method of determining the proper spinal implant length using length trials; FIG. 9 depicts a top plan view of one embodiment of the surgical instrumentation kit for a total joint replacement spinal implant system procedure; FIGS. 10A-10C depict different views of one embodiment of a length trial; FIGS. 11A-11B depict different views of the length trial within an intravertebral space within a spine region; FIG. 11C depicts a top view of a length trial and its angle of convergence in different spine segments; FIGS. 12A-12D graphically illustrates different embodiments of a method of determining the proper spinal implant height using height trials; FIGS. 13A-13C depict different views of one embodiment of a height trial; FIG. 14 depict a sagittal view of the height trial within an intravertebral space within a spine region; FIGS. 15A-15C graphically illustrates different embodiments of a method of preparing an intravertebral space within a localized spine segment for alignment restoration; FIGS. 16A-16E graphically illustrates different embodiments of a method of preparing the caudal vertebral body; FI