Hinge-connector spinal correction device and method

Abstract

A spinal correction device includes a stabilizer assembly including: a hinge including: a first rod carrier; the second rod bearing piece is rotatably connected to the first rod bearing piece, so that the stabilizer assembly has a coronal plane motion freedom degree or a sagittal plane motion freedom degree or has both the coronal plane motion freedom degree and the sagittal plane motion freedom degree; the locking mechanism is used for locking the first rod bearing piece and the second rod bearing piece at a required angle; the first stabilizer bar is connected with the first bar bearing sheet; the second stabilizer bar is connected with the second bar bearing sheet; and a plurality of single-axis or multi-axis connectors, where each single-axis or multi-axis connector is movably connected to the first or second stabilizer bar and is movably connected to a first spinal rod or a second spinal rod fixed to the spinal column; wherein the stabilizer assembly is connectable to the first or second spinal rod to stabilize the spinal column, preventing compression, traction, or displacement of the spinal cord during spinal correction.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This PCT international application claims priority to U.S. continuation-in-part application No. 18 / 152,018, filed on January 9, 2023, the contents of which are incorporated by reference into this application. Statement on Federally Sponsored Research

[0002] none. Technical Field

[0003] The present invention relates generally to the treatment of spinal deformity. In particular, the present invention relates to the correction of spinal deformity by performing a three-column vertebral body resection. Background Art

[0004] Without limiting the scope of the invention, the background of the present invention is described in conjunction with a device for stabilizing or realigning a deformed spine that has undergone or is undergoing a vertebral column resection (VCR) or spinal correction to a desired position and fixation in that configuration. In some cases of severe spinal deformity, it is recommended to remove one or more vertebrae to allow the spine to adjust to a more normal curvature, which is sometimes achieved in stages over a period of time. To perform a VCR, the spine must be stabilized; realigned to a more normal configuration; maintained in place for a period of time until the spine adapts to that configuration, and sometimes repeatedly stabilized and realigned during subsequent spinal corrections, then maintained in place until the spine adapts to each new configuration. Prior art methods and systems are difficult and risky to implement because they do not allow for precise control over initial VCR stabilization, spinal stabilization, realignment, or long-term fixation without risking compression, traction, or displacement of the spinal cord.

[0005] U.S. Patent No. 9,433,433 filed by Montello et al. purportedly discloses a posterior vertebral plate system comprising a plate and a plurality of connectors. The plate is purportedly provided with a plurality of holes extending from the upper surface to the lower surface thereof, and the plate is configured to extend along the posterior side of at least two vertebral bodies and to be adjacent to at least one bony structure of each vertebral body. The holes are purportedly spaced in a specific manner such that a first set of holes can be positioned on the bony structure of a first vertebral body to define a plurality of fixation points with the first vertebral body, and a second set of holes can be positioned on the bony structure of a second vertebral body to define a plurality of fixation points with the second vertebral body. The connectors can be inserted through the holes in the plate into the bony structure of the corresponding vertebral body to secure the plate to the vertebral body.

[0006] U.S. Patent No. 10,004,538 filed by McNab et al. purportedly discloses a surgical instrument comprising a first arm engageable with a first spinal member disposed on a surface of a first vertebral body. A second arm is purportedly connected to the first arm via a pivot and engageable with a second spinal member disposed on a surface of a second vertebral body. The first arm is purportedly movable to rotate the first spinal member relative to the pivot, and / or the second arm is purportedly movable to rotate the second spinal member relative to the pivot, such that the surface of the first vertebral body moves relative to the surface of the second vertebral body.

[0007] U.S. Patent No. 9,579,126 filed by Zhang et al. and U.S. Patent No. 10,105,166 filed by Zhang et al. purportedly disclose a connector reducer in a spinal fixation system, the system comprising first and second spinal rod manipulators; a first spinal rod manipulator joint connected to the first spinal rod manipulator, a second spinal rod manipulator joint connected to the second spinal rod manipulator; first and second translatable transverse shafts connected to the first and second joints, respectively; and a universal reducer connected to the first and second translatable transverse shafts, wherein the universal reducer, shafts, and connector enable movement and temporary fixation of a spine that has been adjusted to a final position during spinal surgery.

[0008] Methods and systems for stabilizing, adjusting, and immobilizing a deformed spine undergoing VCR are ineffective and risky. It would be desirable to find methods and systems that reduce the risk of stabilizing, adjusting, and immobilizing a deformed spine undergoing VCR to prevent compression, stretching, or displacement of the spinal cord. Summary of the Invention

[0009] In some embodiments of the present disclosure, a device for spinal correction is disclosed, the device comprising a stabilizer assembly comprising: a hinge comprising: a first rod bearing plate; a second rod bearing plate rotatably connected to the first rod bearing plate so that the stabilizer assembly has coronal plane freedom of movement or sagittal plane freedom of movement or both; a locking mechanism for locking the first rod bearing plate and the second rod bearing plate at a desired angle; a first stabilizing rod connected to the first rod bearing plate; a second stabilizing rod connected to the second rod bearing plate; and a plurality of uniaxial or multiaxial connectors, each of which is movably connected to the first stabilizing rod or the second stabilizing rod and movably connected to a first spinal rod fixed to the spine or a second spinal rod fixed to the spine; wherein the stabilizer assembly can be connected to the first spinal rod or the second spinal rod to stabilize the spine and prevent compression, traction or displacement of the spinal cord during spinal correction. In one aspect, the locking mechanism for locking the first rod bearing plate and the second rod bearing plate at the desired angle comprises one or more screws. In another aspect, the first stabilizing bar is connected to the first rod bearing plate by a first threaded portion of the first stabilizing bar. In another aspect, the second stabilizing bar is connected to the second rod bearing plate by a second threaded portion of the second stabilizing bar. In another aspect, each single-axis or multi-axis connector is movably connected to the first stabilizing bar or the second stabilizing bar by one or more adjusting nuts or one or more locking pins. In another aspect, each multi-axis connector can be locked to the first stabilizing bar or the second stabilizing bar and can be angularly locked to the first stabilizing bar or the second stabilizing bar by two or more adjusting nuts. In another aspect, each single-axis or multi-axis connector can be movably connected to the first spinal rod or the second spinal rod by one or more components, each component including a groove shaped to accommodate the first spinal rod or the second spinal rod and can be locked in place by one or more screws. In another aspect, the first stabilizing rod is rotatably connected to the first rod bearing plate so that the first stabilizing rod has freedom of movement in the coronal or sagittal plane, or both; or the second stabilizing rod is rotatably connected to the second rod bearing plate so that the second stabilizing rod has freedom of movement in the coronal or sagittal plane, or both; and the first stabilizing rod has a locking mechanism for locking it in a desired position, or the second stabilizing rod has a locking mechanism for locking it in a desired position. In another aspect, the first stabilizing rod or the second stabilizing rod is threaded, and an adjusting nut is mounted on the first stabilizing rod or the second stabilizing rod so that one or more uniaxial or multiaxial connections on the first stabilizing rod or the second stabilizing rod have longitudinal freedom of movement or locking.

[0010] In some embodiments of the present disclosure, a kit is disclosed, which includes a stabilizer assembly, the stabilizer assembly including: a hinge, the hinge including: a first rod bearing plate; a second rod bearing plate, the second rod bearing plate rotatably connected to the first rod bearing plate so that the stabilizer assembly has coronal plane freedom of movement or sagittal plane freedom of movement, or both; a locking mechanism for locking the first rod bearing plate and the second rod bearing plate at a desired angle; a first stabilizing rod, the first stabilizing rod being connected to the first rod bearing plate; a second stabilizing rod, the second stabilizing rod being connected to the second rod bearing plate; and a plurality of single-axis or multi-axis connectors, each of which is movably connected to the first stabilizing rod or the second stabilizing rod, and is movably connected to a first spinal rod fixed to the spine or a second spinal rod fixed to the spine; wherein the stabilizer assembly can be connected to the first spinal rod or the second spinal rod to stabilize the spine and prevent compression, traction or displacement of the spinal cord during spinal correction. In one aspect, the first stabilizing rod is rotatably connected to the first rod bearing plate so that the first stabilizing rod has freedom of movement in the coronal or sagittal plane, or both; or the second stabilizing rod is rotatably connected to the second rod bearing plate so that the second stabilizing rod has freedom of movement in the coronal or sagittal plane, or both; and the first stabilizing rod has a locking mechanism to lock it in a desired position, or the second stabilizing rod has a locking mechanism to lock it in a desired position. In another aspect, the first stabilizing rod or the second stabilizing rod is threaded, and an adjusting nut is mounted on the first stabilizing rod or the second stabilizing rod so that one or more of the multiple uniaxial or multiaxial connections on the first stabilizing rod or the second stabilizing rod have longitudinal freedom of movement or locking.

[0011] In some embodiments of the present disclosure, a method for stabilizing a spine is disclosed, the method comprising positioning a patient in need of spinal stabilization, wherein a plurality of spinal rods are secured to the patient's spine; connecting a stabilizer assembly of a spinal correction device to at least one of the plurality of spinal rods, wherein the stabilizer assembly comprises: a hinge, the hinge comprising: a first rod bearing piece; a second rod bearing piece rotatably connected to the first rod bearing piece so that the stabilizer assembly has coronal or sagittal freedom of motion, or both; a locking mechanism for locking the first rod bearing piece and the second rod bearing piece. A rod bearing plate is locked at a desired angle; a first stabilizing rod is connected to the first stabilizing rod; a second stabilizing rod is connected to the second stabilizing rod; and a plurality of uniaxial or multiaxial connectors, wherein each uniaxial or multiaxial connector is movably connected to the first stabilizing rod or the second stabilizing rod and is movably connected to a first spinal rod or a second spinal rod fixed to the spine; and stabilizing the spine in a desired spinal configuration; wherein the stabilizer assembly is connectable to the first or second spinal rod to stabilize the spine and prevent compression, traction, or displacement of the spinal cord during spinal correction. In one aspect, the locking mechanism for locking the first and second rod bearing plates at the desired angle comprises one or more screws. In another aspect, the first stabilizing rod is connected to the first rod bearing plate via a first threaded portion of the first stabilizing rod. In another aspect, the second stabilizing rod is connected to the second rod bearing plate via a second threaded portion of the second stabilizing rod. In another aspect, each uniaxial or multiaxial connector is movably connected to the first or second stabilizing rod via one or more adjustment nuts or one or more locking pins. In another aspect, each multi-axial connector is lockable to the first or second stabilizing rod and can be angularly locked to the first or second stabilizing rod by two or more adjustment nuts. In another aspect, each uniaxial or multi-axial connector is movably connected to the first or second spinal rod by one or more components, each component including a recess for receiving the first or second spinal rod and lockable in place by one or more screws. In another aspect, the first stabilizing rod is rotatably connected to the first rod bearing plate so that the first stabilizing rod has coronal or sagittal plane freedom of movement, or both; or the second stabilizing rod is rotatably connected to the second rod bearing plate so that the second stabilizing rod has coronal or sagittal plane freedom of movement, or both; and the first stabilizing rod has a locking mechanism for locking it in a desired position, or the second stabilizing rod has a locking mechanism for locking it in a desired position. In another aspect, the first or second stabilizing rod has threads, and an adjustment nut is mounted on the first or second stabilizing rod so that one or more uniaxial or multi-axial connectors on the first or second stabilizing rod have longitudinal freedom of movement or lock.In another aspect, the method further includes coupling the stabilizer assembly to at least one of the plurality of spinal rods, the spinal rods being oriented to provide the hinge with coronal, sagittal, or a combination of coronal and sagittal degrees of freedom. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] For a more complete understanding of the features and advantages of the present invention, reference is now made to the detailed description of the invention and to the accompanying drawings, in which:

[0013] Figure 1A 、 1B and 1C show a stabilizer assembly.

[0014] Figure 2A Another stabilizer assembly is shown.

[0015] Figure 2B 、 2C and 2D shows Figure 2A A top view of the stabilizer assembly is shown in FIG.

[0016] Figure 2E 、 2F and 2G shows Figure 2A A perspective view of the stabilizer assembly is shown.

[0017] Figure 2H Shows the use of a wrench to adjust the adjusting nut Figure 2A A view of the stabilizer assembly is shown.

[0018] Figure 2I Shown Figure 2A Side view of the stabilizer assembly shown.

[0019] Figure 3A A single axis connection is shown.

[0020] Figure 3B Another single axis connection is shown.

[0021] Figure 3C Yet another uniaxial connection is shown.

[0022] Figure 3D A cross section of a multi-axial connection is shown.

[0023] Figure 3E 、 3F , 3G and 3H show Figure 3D A perspective view of the multi-axis connection shown.

[0024] Figure 3I A perspective view of another multi-axis connection is shown.

[0025] Figure 3JA perspective view of another multi-axis connection is shown.

[0026] Figure 4A 、 4B and 4C shows Figure 1A 、 1B The stabilizer assembly shown in Figure 1C is connected to the spinal rod, wherein the spinal rod is fixed to the simulated spine.

[0027] Figure 5A and 5B Shown Figure 1A 、 1B Schematic diagram of the stabilizer assembly shown in 1C when used together with the operating assembly.

[0028] Figure 6A 、 6B and 6C are used Figure 2A Schematic diagram of the stabilizer assembly showing coronal control correction, sagittal control correction, and longitudinal correction.

[0029] Figure 6D and 6E For use Figure 2A Schematic diagram of the stabilizer assembly performing two different sagittal plane control corrections, Figure 6F Shown Figure 6E Top view of the sagittal control correction shown in .

[0030] Figure 6G 、 6H , 6I and 6J show Figure 2I Multiple angle views of the stabilizer assembly are shown.

[0031] Figure 7A For use Figure 2I Schematic diagram of the stabilizer assembly for coronal controlled correction.

[0032] Figure 7B For use Figure 2I Schematic diagram of the stabilizer assembly showing sagittal plane control correction.

[0033] Figure 7C For use Figure 2I Schematic diagram of the stabilizer assembly performing longitudinal correction.

[0034] Figure 7D Shown Figure 2I A stabilizer assembly is shown where the hinge is located at the apex of spinal deformation where VCR has been performed.

[0035] Figure 7E and 7F Shows how to Figure 2I The hinge of the stabilizer assembly shown is Figure 5A and5B The illustrated operating components are used together to perform spinal correction.

[0036] Figure 7G Shows how to use Figure 2I The hinge of the stabilizer assembly shown in FIG. Figure 7E and 7F Spinal correction shown in .

[0037] Figure 8 A flow chart illustrating one embodiment of a method of the present invention is shown.

[0038] Figure 9A The operating lever and operating clamp are shown, along with the stabilizer assembly.

[0039] Figure 9B The operating lever is shown ready to be connected to the hinge of the stabilizer assembly.

[0040] Figure 9C Shown is a side view of an operating clamp connected to a stabilization rod and a spinal rod.

[0041] Figure 9D The distal end of the operating clamp is shown connected to the stabilization rod and the spinal rod.

[0042] Figure 9E The rod carrying piece of the stabilizer assembly is shown.

[0043] Figure 9F Shown are the rod-carrying pieces of the stabilizer assembly connected at a hinge. DETAILED DESCRIPTION

[0044] An illustrative embodiment of the system of the present application is described below. For the sake of clarity, not all features of an actual embodiment are described in this specification. Of course, it should be understood that many implementation-specific decisions must be made in the development of any such actual embodiment to achieve the developer's specific goals, such as compliance with system-related and business-related constraints, which will vary from implementation to implementation. Furthermore, it should be understood that such development work may be complex and time-consuming, but is still a routine task for those of ordinary skill in the art who benefit from this disclosure.

[0045] In this specification, reference may be made to the spatial relationships between various components and the spatial orientation of various aspects of the components as the various devices are shown in the accompanying drawings. However, as will be appreciated by those skilled in the art after reading this application in its entirety, the devices, components, apparatus, etc. described herein may be positioned in any desired orientation. Thus, the use of terms such as "above," "below," "upper," "lower," or other similar terms to describe the spatial relationships between various components or to describe the spatial orientation of various aspects of such components should be understood to describe the relative relationship between such components or the spatial orientation of various aspects of such components, respectively, as the devices described herein may be positioned in any desired orientation.

[0046] Figure 1A and 1B One embodiment of the present invention that prevents compression, traction, or displacement of the spinal cord during corpectomy surgery is shown, namely, stabilizer assembly 100 . Figure 1A is a side view, Figure 1B is a top view. The stabilizer assembly 100 includes a hinge 105, which includes rod carriers 110 and 115 and a hinge locking mechanism 120. The rod carrier 115 is rotatably connected to the rod carrier 110 to achieve freedom of movement in the coronal plane or sagittal plane, or both, depending on the orientation of the stabilizer assembly relative to the spine. The hinge locking mechanism 120 is used to lock the rod carriers 110 and 115 at a desired angle. Stabilizing rods 125 and 130 are connected to the rod carriers 110 and 115 by, for example, threaded portions of the stabilizing rods 125 and 130 near the hinge 105. The stabilizing rods 125, 130, or both are threaded, and an adjusting nut is mounted on the stabilizing rods 125, 130, or both to achieve freedom of movement in the longitudinal direction.

[0047] Figure 1C The stabilizer assembly 100 of the present invention is shown connected to spinal rods 135 and 140, which may be straight or curved. Figure 1C Hinge 105 is shown, which includes rod bearing pieces 110 and 115, locking mechanism 120, stabilizing rods 125 and 130, and four connectors 145a, 145b, 145c, and 145d. Connectors 145a, 145b, 145c, and 145d are connected to spinal rods 135 and 140. Connectors 145a, 145b, 145c, and 145d represent various embodiments of connectors according to the present invention, including uniaxial and multiaxial connectors as described herein.

[0048] Figure 2AAnother embodiment of the present invention is shown that prevents compression, traction or displacement of the spinal cord during corpectomy surgery, namely, a stabilizer assembly 200. The stabilizer assembly includes a hinge 205 that is configured to provide the stabilizer assembly with freedom of movement in the coronal or sagittal plane, or both, depending on the orientation of the stabilizer assembly relative to the spine. Rod bearing plates 210 and 215 are rotatably connected to achieve freedom of movement in the coronal or sagittal plane, or both, depending on the orientation of the stabilizer assembly relative to the spine. A hinge locking mechanism 220 is used to lock the rod bearing plates 210 and 215 at a desired angle. Stabilizing rods 225 and 230 have threads on at least a portion of their respective lengths and are connected to the rod bearing plates 210 and 215 by, for example, threaded portions on the ends of the stabilizing rods 225 and 230 near the hinge 205. Stabilizing rods 225 and 230 are rotatably connected to rod carriers 210 and 215, respectively, and have the freedom to move about rotational axes perpendicular to the planes formed when rod carriers 210 and 215 are at a 180-degree angle. Locking mechanisms 232 and 234 are used to lock stabilizing rods 225 and 230 in a desired position, respectively. Stabilizing rods 225 and 230 have a threaded structure and are equipped with exemplary adjustment nuts 235a, 235b, 235c, and 235d to enable a connecting member (not shown) to move longitudinally along the stabilizing rods 225 and 230, thereby achieving the freedom of longitudinal movement along the stabilizing rods 225 and 230. The adjustment nuts 235a, 235b, 235c, and 235d can be used to secure the connecting member at a specific position on the stabilizing rods 225 and 230.

[0049] Figure 2B A top view of the stabilizer assembly 200 is shown with the rod-bearing pieces 210 and 215 of the hinge 205 at a 180 degree angle. Figure 2C and 2D The stabilizer assembly 200 is shown in top views, with the rod-bearing pieces 210 and 215 of the hinge 205 at different angles, to exemplify the coronal plane freedom of motion that the hinge 205 can provide.

[0050] Figure 2E A side view of the stabilizer assembly 200 is shown with the rod-carrying pieces 210 and 215 of the hinge 205 at a 180 degree angle and the stabilizer rods 225 and 230 aligned with each other. Figure 2F and 2G A side view of the stabilizer assembly 200 is shown with the rod-bearing pieces 210 and 215 of the hinge 205 at a 180 degree angle and the stabilizer rods 225 and 230 at different angles to exemplify the sagittal plane freedom of motion of the stabilizer rods 225 and 230 .

[0051] Figure 2HA side view of the stabilizer assembly 200 is shown, wherein the rod-bearing plates 210 and 215 of the hinge 205 are at a 180-degree angle, the stabilizer rods 225 and 230 are aligned with each other, and the wrench 240 is used to adjust the position of the adjusting nut 235 so that it moves longitudinally along the stabilizer rod 230, thereby positioning the connecting member (not shown) on the stabilizer rod 230.

[0052] Figure 2I A side view of stabilizer assembly 200 is shown, with rod-bearing pieces 210 and 215 of hinge 205 at a 180-degree angle, stabilizer bars 225 and 230 aligned with each other, and eight exemplary adjustment nuts 235a, 235b, 235c, 235d, 235e, 235f, 235g, and 235h, four on each of stabilizer bars 225 and 230. The adjustment nuts can be made of any material, such as metal, polymer, composite material, etc.

[0053] Figure 3A A single-axis connection 300 of the present invention is shown. Figure 3A A uniaxial connector 300 of the present invention is shown. Multiple connectors 300 can be movably connected to one or more (not shown) of the stabilizer bars 125 and 130 via an upper end 302 of each connector 300. Each connector 300 can be positioned and locked at any position on the stabilizer bar 125 or 130, for example, by a set screw 304. Each connector 300 can be movably connected to a spinal rod (not shown) fixed to the spine at its lower end 306, for example, by a bone screw. Each connector 300 can be positioned and locked at any position on the spinal rod, for example, by a set screw 308.

[0054] Figure 3B Another uniaxial connector 310 of the present invention is shown. Multiple connectors 310 can be movably connected to one or both of the stabilizing rods 125 and 130 via an upper end 312 of each connector 310. Each connector 310 can be positioned and locked at any position on the stabilizing rod 125 or 130, for example, by a set screw 314. Each connector 310 can be movably connected to a spinal rod (not shown) fixed to the spine via a lower end 316 thereof, for example, by a bone screw. Each connector 310 can be positioned and locked at any position on the spinal rod, for example, by a set screw 318.

[0055] Figure 3CAnother uniaxial connector 320 of the present invention is shown. A plurality of connectors 320 can be movably connected to one or both of the stabilizing rods 125 and 130 (not shown) by the upper end 322 of each connector 320. Each connector 320 can be positioned to any position on the stabilizing rod 125 or 130 by, for example, a locking pin (not shown) passing through a hole 324 to remain on the stabilizing rod 125 or 130 (not shown). Each connector 320 can be movably connected to a spinal rod (not shown) fixed on the spinal column by, for example, a bone screw by a lower end 326. Each connector 320 can be positioned to any position on the spinal rod and locked by, for example, a set screw 328.

[0056] Figure 3D shows a cross-sectional view of a multi-axial connection 340 of the present invention, and Figure 3E 、 3F3G and 3H show perspective views of a multi-axial connector 340 according to the present invention, each illustrating one or more features of the multi-axial connector 340 in different states. Each of the plurality of multi-axial connectors 340 is movably connected to one of the stabilizer bars 125 and 130 (stabilizer bar 125 is shown, while stabilizer bar 130 is not shown) via an upper portion 342 of each multi-axial connector 340. Each multi-axial connector 340 can be positioned and locked at any position on the stabilizer bar 125 or 130 (130 not shown) using, for example, a pair of adjustment nuts 344a and 344b (shaped to match the upper end 342). These adjustment nuts 344a and 344b, as well as similar nuts elsewhere on the threaded stabilizer bar 125 or 130 (130 not shown), can be locked and unlocked multiple times without damaging the threads of the adjustment nuts or the threads of the stabilizer bar. The upper portion 342 of the multi-axial connector 340 is spherical and has a recess 346 formed therein. The recess is configured to receive the stabilizer bar 125 or 130 (not shown). The recess 346 is wider than the stabilizer bar 125 or 130 (not shown), and the bottom of the recess 346 includes two inclined portions 348a and 348b that intersect at an apex 350. When the multi-axial connector 340 is positioned on the stabilizer bar 125 or 130 (not shown), the stabilizer bar 125 or 130 (not shown) contacts at least the apex 350, thereby keeping the stabilizer bar 125 or 130 (not shown) at the center of the groove 346. The width of the groove 346 and the inclined portions 348a and 348b allow the multi-axial connector 340 to be adjusted relative to the axis of the stabilizer bar 125 or 130 (not shown) by an angle of, for example, 10, 15, 20, 25, 30, 35, 40, 45, or more, in any direction. When the stabilizer bar 125 or 130 (not shown) reaches the desired angle in the groove 346 and the multi-axial connector 340 is in the desired position on the stabilizer bar 125 or 130 (not shown), the multi-axial connector 340 can be locked in place using the adjusting nuts 344a and 344b. A locking pin 352 may also be used to further secure the stabilization rod 125 or 130 (not shown) in place. The lower portion 354 of the multi-axial connector 340 includes a recess 356 shaped to receive a spinal rod 146 secured to the patient's spine (not shown). Each multi-axial connector 340 may be positioned at a desired location on the spinal rod 146 and secured in place by, for example, a set screw 358.

[0057] Figure 3E The multi-axial connection 340 is shown with the adjustment nuts 344a, 344b in a non-engaged state. Figure 3FThe multi-axial connection 340 is shown from a top perspective with the adjustment nuts 344a and 344b engaged and the multi-axial connection 340 locked to the stabilizer bar 125 at a certain angle. Figure 3G The multi-axial connection 340 is shown with the adjustment nut 344a in an engaged state, the adjustment nut 344b in a non-engaged state, and the locking pin 352 in place. Figure 3H The multi-axial connection 340 is shown with both adjustment nuts 344a and 344b engaged.

[0058] Figure 3I A perspective view of multi-axial connection 340 is shown, illustrating upper portion 342 , groove 346 , lower portion 354 , and groove 356 .

[0059] Figure 3J A perspective view of a multi-axial connector 360 is shown. The multi-axial connector 360 is similar to the multi-axial connector 340, but the bottom end 374 of the multi-axial connector 360 has two components or claws 374a and 374b. The claws 374a and 374b have grooves 376a and 376b, respectively, which are shaped to accommodate the spinal rod 146 (not shown) to enable engagement with the spinal rod 146 in two locations. The multi-axial connector 360 can be locked to the spinal rod 146 by screws 378a and 378b. The multi-axial connector 360 engages the spinal rod 146 in two locations, which can achieve greater stability after engagement compared to a single component or single claw multi-axial connector (such as the multi-axial connector 340). Regarding other features of the multi-axial connector 360, Figure 3J The upper portion 362 of the multi-axis connector 360 is shown having a recess 366 shaped to receive a stabilizer bar 125 or 130 (not shown). Components or claws similar to the claws 374a and 374b may also be used in the single-axis connector disclosed herein.

[0060] Figure 4A 、 4B 4C illustrate the stabilizer assembly 100 of the present invention coupled to spinal rods 135 and 140 , wherein the spinal rods 135 and 140 are secured to a simulated spine 400 . Figure 4A and 4B Hinge 105 is shown located at the apex of the spinal deformity where VCR has been performed. Figure 4C Hinge 105 is shown located at the apex of the spinal deformity where the deformity has been corrected.

[0061] Figure 5A and 5B The stabilizer assembly 100 and the operating assembly 500 are shown in a scenario of being used in conjunction with each other. Figure 5A and 5BThe stabilizer assembly 100 and the manipulation assembly 500 are shown as being used together to perform spinal correction. The manipulation assembly 500 includes handles 505 and 510 and a connecting rod 515. The connecting rod 515 is removably connected to the handles 505 and 510, for example, by one or more clamps or one or more screws, to stabilize or fix the position of the handles 505 and 510 relative to each other as desired. The handles 505 and 510 can be connected to the spinal rods 135 and 140 to adjust the spine to a desired configuration for the stabilizer assembly to maintain. Figure 5A and 5B The manipulation assembly 500 is shown connected to two spinal rods 135 and 140, respectively, with handles 505 and 510 in different relative positions and the simulated spine 400 adjusted to two different desired configurations. The stabilizer assembly 100 is also shown.

[0062] Figure 6A Schematic diagram of coronal plane controlled correction using stabilizer assembly 200. Rod bearing plates 210 and 215 are set at desired angles to position simulated spine 400 in the desired configuration. Figure 6B Schematic diagram of sagittal plane control correction using stabilizer assembly 200. Stabilizer rods 225 and 230 are placed in desired locations to position simulated spine 400 in a desired configuration. Figure 6C Schematic diagram of longitudinal correction using stabilizer assembly 200. Connectors 145a, 145b, 145c, and 145d are positioned at desired locations with the aid of adjusting nuts 635a, 635b, 635c, 635d, 635e, and 635f.

[0063] Figure 6D Schematic diagram of sagittal plane control correction using stabilizer assembly 200. Stabilizer rods 225 and 230 are placed in desired locations to position simulated spine 400 in a desired configuration. Figure 6E Schematic diagram of using stabilizer assembly 200 for sagittal plane control correction. Figure 6D The position shown is rotated 90 degrees to allow sagittal plane freedom of motion for the hinge 205. The rod bearing pieces 210 and 215 of the hinge 205 are set at the desired angles to position the simulated spine 400 in the desired configuration. Figure 6F for Figure 6E Top view of the midsagittal control correction.

[0064] Figure 6G 、 6H, 6I and 6J show various views of the stabilizer assembly 200, including adjustment nuts 344a, 344b, 344c and 344d (wherein adjustment nuts 344c and 344d are similar to adjustment nuts 344a and 344b); retaining pins 352a, 352b, 352c and 352d; multi-axial connectors 360a and 360b; and single-axial connectors 320a and 320b mounted on stabilization arms 225 and 230, and a simulated spine 600. Figure 6G All of these components are shown, with the hinge 200 shown located at the apex of the spinal deformity where VCR has been performed. Figure 6H Hinge 200 is shown located at the apex of the spinal deformity where the deformity has been corrected. Figure 6I Shown Figure 6G Another view (concave side view). Figure J shows Figure 6H Another view (concave side view).

[0065] exist Figure 6G 、 6H , 6I and 6J, the adjusting nuts 344a, 344b, 344c and 344d; the multi-axis connectors 360a and 360b; and the single-axis connectors 320a and 320b all include a coating All single-axis connectors, multi-axis connectors, and adjusting nuts discussed herein may include metal, A combination of the two (e.g. coated metals), polymers, composites.

[0066] Figures 7A-7G Shown Figure 2I Various applications of the stabilizer assembly 200 are shown in FIG. Figure 7A Schematic diagram of coronal plane controlled correction using the stabilizer assembly 200. Figure 7B Schematic diagram of using the stabilizer assembly 200 to perform sagittal plane control correction. Figure 7C Schematic diagram of longitudinal correction using the stabilizer assembly 200. Figure 7D The stabilizer assembly 200 is shown with the hinge 205 located at the apex of the spinal deformity where VCR has been performed. Figure 7E and 7F Shows how to connect the hinge of the stabilizer assembly 200 to the Figure 5A and 5B The illustrated operating assembly 500 is used together to perform spinal correction. Figure 7G Shows how to use the hinge 205 of the stabilizer assembly 200 to stabilize Figure 7E and 7F Spinal correction shown.

[0067] Embodiments of the present invention may be used in conjunction with existing instruments, tools, and other equipment used to treat spinal disorders.

[0068] The components of the present invention, including the stabilizer assembly and the multi-axial connector, can be made of durable, implantable, non-biological materials such as titanium, stainless steel, spring steel, aluminum, niobium, carbon fiber, ceramics, polymers, composites, or any relatively rigid alternative material (e.g., titanium-aluminum-niobium alloy). Generally, the selected material should be biocompatible, i.e., compatible with surrounding bone and tissue.

[0069] Figure 8 A flow chart illustrating an embodiment of the method of the present invention is shown. A method 800 for stabilizing a spine includes step 805 of positioning a patient in need of spinal stabilization, wherein a plurality of spinal rods have been secured to the patient's spine. Step 810 includes connecting a stabilizer assembly of a spinal correction device to at least one of the plurality of spinal rods, wherein the stabilizer assembly includes a hinge comprising: a first rod bearing plate; a second rod bearing plate rotatably connected to the first rod bearing plate to provide the stabilizer assembly with coronal or sagittal freedom of motion, or both; a locking mechanism for locking the first and second rod bearing plates at a desired angle; a first stabilizer rod connected to the first rod bearing plate; and a second stabilizer rod connected to the second rod bearing plate, wherein the first stabilizer rod, the second stabilizer rod, or both are threaded and an adjustment nut is mounted on the first stabilizer rod, the second stabilizer rod, or both to provide longitudinal freedom of motion; and a plurality of multi-axial connectors, wherein each multi-axial connector is movably connected to the first stabilizer rod or the second stabilizer rod and movably connected to the first spinal rod or the second spinal rod fixed to the spine. Step 815 includes securing the spine in a desired spinal configuration. In step 820, a stabilizer assembly is connected to the first spinal rod or the second spinal rod to stabilize the spine and prevent compression, traction, or displacement of the spinal cord during spinal correction.

[0070] Figure 9A An operating rod 905 and an operating clamp 915 are shown along with the stabilizer assembly 200. Although the operating rod 905 and the operating clamp 915 are shown and discussed in conjunction with the stabilizer assembly 200, they can be used in conjunction with other embodiments of the stabilizer assembly, such as the stabilizer assembly 100 (not shown). As shown, the operating rod 905 is connected to the hinge 205 of the stabilizer assembly 200, and the operating clamp 915 is connected to the stabilizer rod 230 of the stabilizer assembly 200 and to the spinal rod 140. The operating clamp 915 can also be connected to the stabilizer rod 225 of the stabilizer assembly 200 and to the spinal rod 135.

[0071] Figure 9BAn operating rod 905 is shown to be coupled to the hinge 205 of the stabilizer assembly 200. The operating rod 905 includes a handle 907 secured to the proximal end of the operating rod 905, a rod body 909, and a connecting mechanism 911 secured to the distal end of the operating rod 905. In an exemplary embodiment, the connecting mechanism 911 includes a threaded recess (not shown) configured to be threadably coupled to a threaded hinge bolt 913. Once coupled to the hinge 205, the operating rod 905 can be used to manipulate the stabilizer assembly 200. The rod body 909 can be straight or curved, and its cross-section can be circular, oval, triangular, square, pentagonal, hexagonal, or other polygonal.

[0072] Figure 9C A side view of an operating clamp 915 coupled to the stabilization rod 230 and the spinal rod 140 is shown. The operating clamp 915 includes two clamp arms 917a, b rotatably coupled to one another. At the proximal end of the operating clamp 915, the two clamp arms 917a, b are engaged with one another via a disengageable ratchet mechanism 919. At the distal end of the operating clamp 915, each clamp arm 917a, b includes a clamping surface, i.e., a clamping surface 921a, b, having grooves therein for engaging the stabilization rod 230 and the spinal rod 140.

[0073] Figure 9D The distal end of the operating clamp 915 is shown connected to the stabilizing rod 230 and the spinal rod 140. At the distal end of the operating clamp 915, each of the clamp arms 917a, b includes a clamping surface, respectively, 921a, b (921b is not shown), which has grooves for engaging with the stabilizing rod 230 and the spinal rod 140.

[0074] Figure 9E Rod carriers 210 and 215 of stabilizer assembly 200 are shown, respectively. Rod carrier 215 includes a bolt hole 925 configured to receive a bolt 927 carrying a nut 929, such that bolt 927 is received by rod carrier 210. Bolt 927 connects stabilizer rod 230 to rod carrier 215. Similarly, rod carrier 210 includes a bolt hole 931 configured to receive a bolt (not shown) carrying a nut (not shown), such that bolt 927 is received by rod carrier 210, thereby connecting stabilizer rod 225 (not shown) to rod carrier 210.

[0075] Figure 9F The rod carrying pieces 210 and 215 of the stabilizer assembly 200 are shown connected at hinge 205. Figure 9F , the rod bearing pieces 210 and 215 are coupled by hinge bolt 913 and bolts 927 and 933, wherein the bolts 927 and 933 carry nuts 929 and 935, respectively, and are partially inserted into bolt holes 925 and 931, respectively (not shown).

[0076] It will be appreciated by those skilled in the art of human hip disease treatment that the apparatus for treating spinal diseases, including stabilizer assembly 100, stabilizer assembly 200, and method 700, provides an effective method and system for reducing the risk of spinal cord compression, traction, or displacement during stabilization, adjustment, and fixation of a deformed spine that has undergone a three-column vertebral resection or spinal correction.

[0077] It should be understood that the specific embodiments described herein are presented by way of illustration and not by way of limitation of the present invention. Without departing from the scope of the present invention, the main features of the present invention may be employed in various embodiments. Those skilled in the art will recognize or be able to determine many equivalents of the specific processes described herein using no more than routine experimentation. Such equivalents are considered to be within the scope of the present invention and are encompassed by the claims.

[0078] All publications and patent applications mentioned in this specification are indicative of the levels of skill of those skilled in the art. All publications and patent applications are incorporated herein by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0079] When used in conjunction with the term "comprising" in the claims and / or the specification, the article "a" or "an" can mean "one", but can also mean "one or more", "at least one", and "one or more than one". Unless expressly indicated to refer only to alternatives or the alternatives are mutually exclusive, the use of the term "or" in the claims means "and / or", but the present disclosure also supports limitations referring only to alternatives and "and / or". In this application, the term "about" is used to indicate that a value includes the inherent variation of error for a device, for the method being used to determine the value, or for the variation that exists between the subjects of study.

[0080] As used in this specification and claims, the words "comprising" (and any forms thereof, such as "comprise" and "comprises"), "having" (and any forms thereof, such as "have" and "has"), "including" (and any forms thereof, such as "includes" or "include"), or "containing" (and any forms of containing, such as "contains" and "contain") are inclusive or open-ended and do not exclude additional, unrecited elements or method steps. In any embodiment of the compositions and methods provided herein, "comprising / including / containing" may be replaced with "consisting essentially of" or "consisting of." As used herein, the phrase "consisting essentially of requires the specified integer or step and integers or steps that do not materially affect the feature or function of the claimed invention. As used herein, the term “consisting of” is used to indicate that only the recited integer (e.g., feature, element, characteristic, property, method / process step, or limitation) or group of integers (e.g., one or more features, one or more elements, one or more characteristics, one or more properties, one or more method / process steps, or one or more limitations) is present.

[0081] As used herein, the term "or combinations thereof" refers to all permutations and combinations of the listed items preceding the term. For example, "A, B, C, or combinations thereof" is intended to include at least one of A, B, C, AB, AC, BC, or ABC, and if order is important in a particular case, BA, CA, CB, CBA, BCA, ACB, BAC, or CAB is also included. Continuing with this example, combinations containing repetitions of one or more items or terms (such as BB, AAA, AB, BBC, AAABCCCC, CBBAAA, CABABB, etc.) are explicitly included. It will be understood by those skilled in the art that, unless apparent from the context, there is generally no limit to the number of items or terms in any combination.

[0082] As used herein, approximately qualifiers such as, but not limited to, "about," "substantially," or "approximately" refer to conditions that, when so modified, are understood not to be necessarily absolute or exact, but rather to be close enough for one of ordinary skill in the art to ensure that such conditions exist. The extent to which the description can vary will depend on how much of a change can be made and still allow one of ordinary skill in the art to recognize the modified feature as still having the desired properties and capabilities of the unmodified feature. In general, but subject to the preceding discussion, numerical values ​​modified herein by an approximate word such as "about" may vary from the stated value by at least ±1, 2, 3, 4, 5, 6, 7, 10, 12, or 15%.

[0083] All of the devices and / or methods disclosed and claimed herein can be made and implemented without undue experimentation in light of the present disclosure. Although the devices and methods have been described with respect to specific embodiments, it will be apparent to those skilled in the art that variations may be implemented in the compositions and / or methods described herein, as well as in the steps or sequence of steps in the methods, without departing from the concept, spirit, and scope of the present invention. All such similar substitutions and modifications apparent to those skilled in the art are deemed to fall within the spirit, scope, and concept of the present invention as defined by the appended claims.

[0084] Furthermore, no limitations are intended to the details of construction or design shown herein, except as described in the appended claims. Therefore, it is understood that the specific embodiments disclosed above may be altered or modified, and all such variations are considered to be within the scope and spirit of this disclosure. Therefore, the protection sought herein is as described in the appended claims.

[0085] The systems and devices described herein may be modified, added to, or omitted without departing from the scope of the present invention. The components of the systems and devices may be integrated or separate. Furthermore, the operations of the systems and devices may be performed by more, fewer, or other components. The methods may include more, fewer, or other steps. Furthermore, the steps may be performed in any suitable order.

[0086] To assist the Patent Office and any reader of a patent that may issue based upon this application in interpreting the claims appended hereto, Applicant wishes to point out that, unless the phrase "means for" or "step for" is expressly used in a particular claim, Applicant does not intend that any of the appended claims would trigger 35 U.S.C. § 112(f) by virtue of their existence as of the filing date.

Claims

1. An operating rod for use with a spinal correction device, the operating rod comprising: a grip located at the proximal end of the operating rod; a rod body fixed to the handle; as well as a connecting mechanism fixed to the rod body at the distal end of the operating rod; The operating rod is configured to be connected to a hinge of the spinal correction device, and the spinal correction device comprises: A stabilizer assembly, the stabilizer assembly comprising: The hinge comprises: a first rod carrying sheet; a second rod bearing piece rotatably connected to the first rod bearing piece to provide the stabilizer assembly with freedom of motion in the coronal plane, freedom of motion in the sagittal plane, or both; a locking mechanism for locking the first rod carrier piece and the second rod carrier piece at a desired angle; a first stabilizing bar connected to the first bar-bearing sheet; and a second stabilizing bar connected to the second bar bearing piece; and The stabilizer assembly can be connected to a first spinal rod or a second spinal rod fixed to the spine to stabilize the spine and prevent compression, traction or displacement of the spinal cord during spinal correction.

2. The operating lever according to claim 1, wherein The rod body is straight.

3. The operating lever according to claim 1, wherein The rod body is curved.

4. The operating lever according to claim 1, wherein The rod body has a cross section of a circle, an ellipse, a triangle, a square, a pentagon, a hexagon or other polygons.

5. The operating lever according to claim 1, wherein The connection mechanism includes a threaded groove configured to receive a threaded bolt.

6. A kit comprising: An operating rod for use with a spinal correction device, the operating rod comprising: a grip located at the proximal end of the operating rod; a rod body fixed to the handle; and a connecting mechanism fixed to the rod body at the distal end of the operating rod; wherein the operating rod is configured to be connected to a hinge of the spinal correction device; and The spinal correction device comprises: A stabilizer assembly, the stabilizer assembly comprising: The hinge comprises: a first rod carrying sheet; a second rod bearing piece rotatably connected to the first rod bearing piece to provide the stabilizer assembly with freedom of motion in the coronal plane, freedom of motion in the sagittal plane, or both; a locking mechanism for locking the first rod bearing piece and the second rod bearing piece at a desired angle; a first stabilizing bar connected to the first rod bearing piece; and a second stabilizing bar connected to the second bar bearing piece; and The stabilizer assembly can be connected to a first spinal rod or a second spinal rod fixed to the spine to stabilize the spine and prevent compression, traction or displacement of the spinal cord during spinal correction.

7. The kit according to claim 6, wherein: The rod body of the operating rod is straight.

8. The kit according to claim 6, wherein The rod body of the operating rod is curved.

9. The kit according to claim 6, wherein: The rod body of the operating rod has a cross section of a circle, an ellipse, a triangle, a square, a pentagon, a hexagon or other polygons.

10. An operating fixture for use with a spinal correction device, the operating fixture comprising: two clamp arms rotatably connected to each other, wherein the two clamp arms are engaged with each other at the proximal end of the operating clamp via a disengageable ratchet mechanism, and each clamp arm includes a clamping surface at the distal end of the operating clamp; wherein the operating fixture is configured to engage with a stabilizing rod and a spinal rod of a spinal correction device, wherein the spinal correction device comprises: A stabilizer assembly, the stabilizer assembly comprising: A hinge, comprising: a first rod carrying sheet; a second rod bearing piece rotatably connected to the first rod bearing piece to provide the stabilizer assembly with freedom of motion in the coronal plane, freedom of motion in the sagittal plane, or both; a locking mechanism for locking the first rod carrier piece and the second rod carrier piece at a desired angle; a first stabilizing bar connected to the first bar-bearing sheet; and a second stabilizing bar connected to the second bar bearing piece; and The stabilizer assembly can be connected to a first spinal rod or a second spinal rod fixed to the spine to stabilize the spine and prevent compression, traction or displacement of the spinal cord during spinal correction.

11. The operating jig according to claim 6, wherein: The clamping surface of each clamp arm includes a first groove for engaging the first or second stabilization rod and a second groove for engaging the first or second spinal rod.

12. A kit comprising: An operating fixture for use with a spinal correction device, the operating fixture comprising: two clamp arms rotatably connected to each other, wherein the two clamp arms are engaged with each other at the proximal end of the operating clamp via a disengageable ratchet mechanism, and each clamp arm includes a clamping surface at the distal end of the operating clamp; wherein the operating clamp is configured to engage with a stabilizing rod of a spinal correction device and with a spinal rod; and The spinal correction device comprises: A stabilizer assembly, the stabilizer assembly comprising: A hinge, comprising: a first rod carrying sheet; a second rod bearing piece rotatably connected to the first rod bearing piece to provide the stabilizer assembly with freedom of motion in the coronal plane, freedom of motion in the sagittal plane, or both; a locking mechanism for locking the first rod carrier piece and the second rod carrier piece at a desired angle; a first stabilizing bar connected to the first bar-bearing sheet; and a second stabilizing bar connected to the second bar bearing piece; and The stabilizer assembly can be connected to a first spinal rod or a second spinal rod fixed to the spine to stabilize the spine and prevent compression, traction or displacement of the spinal cord during spinal correction.

13. The kit according to claim 12, wherein The clamping surface of each clamp arm of the operating clamp includes a first groove for engaging the first or second stabilization rod and a second groove for engaging the first or second spinal rod.

14. A spinal correction device comprising: A stabilizer assembly, the stabilizer assembly comprising: A hinge, comprising: a first rod carrying sheet; a second rod bearing piece rotatably connected to the first rod bearing piece to provide the stabilizer assembly with freedom of motion in the coronal plane, freedom of motion in the sagittal plane, or both; a locking mechanism for locking the first rod carrier piece and the second rod carrier piece at a desired angle; a first stabilizing rod connected to the first rod bearing piece; a second stabilizing rod, the second stabilizing rod being connected to the second rod bearing sheet; wherein the first rod bearing plate comprises a first bolt hole configured to receive a second bolt with a nut to connect the first stabilizing rod to the first rod bearing plate, and the second rod bearing plate comprises a second bolt hole configured to receive a second bolt with a nut to connect the second stabilizing rod to the second rod bearing plate; and The stabilizer assembly can be connected to a first spinal rod or a second spinal rod fixed to the spine to stabilize the spine and prevent compression, traction or displacement of the spinal cord during spinal correction.

Images