Hinge-connector spinal correction devices and methods

Abstract

A repositioning device correction system for spinal surgery includes: two single-plane clamps; a repositioning rod having opposing threaded ends configured to connect to each of the two single-plane clamps; a stabilizing rod configured to connect to each of the two single-plane clamps; two temporary spinal rods, each temporary spinal rod configured to connect to a corresponding single-plane clamp; and an adjustable force compression device including a constant force cable configured to connect to each of the two single-plane clamps.

Description

Cross-reference to related applications

[0001] This application is a continuation-in-part of U.S. Serial No. 18 / 354,164, filed July 18, 2023; a continuation-in-part of U.S. Serial No. 18 / 152,018, filed January 9, 2023; a continuation-in-part of U.S. Serial No. 16 / 820,097, filed March 16, 2020; which was now issued on March 7, 2023, under U.S. Patent No. 11,596,446; and is a non-provisional patent application claiming priority to U.S. Provisional Patent Application Serial No. 62 / 822,345, filed March 22, 2019. The entire contents of these patent applications are hereby incorporated by reference.

[0002] Federally Funded Research Statement none. Technical Field

[0003] This invention generally relates to the treatment of spinal deformities. In particular, this invention relates to the correction of spinal deformities by performing a three-column vertebral resection. Background Technology

[0004] Without limiting the scope of the invention, the background of the invention is described in conjunction with a device for stabilizing or adjusting a deformed spine that has undergone or is undergoing vertebral column resection (VCR) or spinal correction to a desired position and fix it in that morphology. In some cases of severe spinal deformities, it is recommended to remove one or more vertebrae to allow the spine to be adjusted to a more normal curvature, which sometimes needs to be achieved in stages over a period of time. For VCR to be performed, the spine must be stabilized; adjusted to a more standard morphology; maintained in situ for a period of time until the spine adapts to that morphology; and sometimes, stabilization and adjustment are repeated in subsequent spinal corrections, followed by maintenance in situ until the spine adapts to each new morphology. Existing methods and systems are difficult to implement and risky because they cannot provide precise control over the initial stabilization, spinal stabilization, adjustment, or long-term fixation of the VCR without the risk of compression, traction, or displacement of the spinal cord.

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

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

[0007] U.S. Patent No. 9,579,126 and U.S. Patent No. 10,105,166, filed by Zhang et al., allegedly disclose a connector repositioning device in a spinal fixation system. The system includes first and second spinal rod manipulators; a first spinal rod manipulator connector connected to the first spinal rod manipulator; a second spinal rod manipulator connector connected to the second spinal rod manipulator; first and second translational transverse axes connected to the first and second connectors, respectively; and a universal repositioning device connected to the first and second translational transverse axes, wherein the universal repositioning device, axes, and connector enable movement and temporary fixation of the spine that has been adjusted to its final position during spinal surgery.

[0008] Methods and systems used for stabilizing, adjusting, and fixing deformed spines via VCR are ineffective and risky. There is a need to find methods and systems to reduce the risks associated with stabilizing, adjusting, and fixing deformed spines via VCR, in order to prevent spinal cord compression, traction, or displacement. Summary of the Invention

[0009] In some embodiments of this disclosure, an apparatus for spinal correction is disclosed, comprising a stabilizer assembly including: a hinge comprising: a first rod support plate; a second rod support plate rotatably connected to the first rod support plate to allow the stabilizer assembly to have coronal or sagittal degrees of freedom, or both; a locking mechanism for locking the first and second rod support plates at a desired angle; a first stabilizing rod connected to the first rod support plate; a second stabilizing rod connected to the second rod support plate; and a plurality of single-axis or multi-axis connectors, each movably connected to the first or second stabilizing rod and movably connected to a first or second spinal rod fixed to the spine; wherein the stabilizer assembly can be connected 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 support plates at a desired angle includes one or more screws. In another aspect, the first stabilizer bar is connected to the first rod support plate via a first threaded portion. In another aspect, the second stabilizer bar is connected to the second rod support plate via a second threaded portion. In yet another aspect, each single-axis or multi-axis connector is movably connected to the first or second stabilizer bar via one or more adjusting nuts or one or more locking pins. In yet another aspect, each multi-axis connector is lockable to the first or second stabilizer bar and can be angledly locked to the first or second stabilizer bar via two or more adjusting nuts. In yet another aspect, each single-axis or multi-axis connector is movably connected to the first or second spindle via one or more components, each component including a groove shaped to receive the first or second spindle and can be locked in place by one or more screws. On the other hand, a first stabilizer bar is rotatably connected to a first bar support plate to give the first stabilizer bar a coronal or sagittal degree of freedom of motion, or both; or a second stabilizer bar is rotatably connected to a second bar support plate to give the second stabilizer bar a coronal or sagittal degree of freedom of motion, or both; and the first stabilizer bar has a locking mechanism for locking it in a desired position, or the second stabilizer bar has a locking mechanism for locking it in a desired position. On the other hand, the first or second stabilizer bar is threaded, and an adjusting nut is mounted on the first or second stabilizer bar to give one or more single-axis or multi-axis connectors on the first or second stabilizer bar a longitudinal degree of freedom of motion or to lock them.

[0010] In some embodiments of this disclosure, a kit is disclosed comprising a stabilizer assembly including: a hinge including: a first rod support plate; a second rod support plate rotatably connected to the first rod support plate to allow the stabilizer assembly to have coronal or sagittal degrees of freedom, or both; a locking mechanism for locking the first and second rod support plates at a desired angle; a first stabilizer bar connected to the first rod support plate; a second stabilizer bar connected to the second rod support plate; and a plurality of single-axis or multi-axis connectors, wherein each single-axis or multi-axis connector is movably connected to the first or second stabilizer bar and movably connected to a first or second spinal bar fixed to the spine; wherein the stabilizer assembly can be connected to the first or second spinal bar to stabilize the spine and prevent compression, traction, or displacement of the spinal cord during spinal correction. In one aspect, a first stabilizer bar is rotatably connected to a first bar support plate to give the first stabilizer bar a coronal or sagittal degree of freedom of motion, or both; or a second stabilizer bar is rotatably connected to a second bar support plate to give the second stabilizer bar a coronal or sagittal degree of freedom of motion, or both; and the first stabilizer bar has a locking mechanism to lock it in a desired position, or the second stabilizer bar has a locking mechanism to lock it in a desired position. In another aspect, the first or second stabilizer bar is threaded, and an adjusting nut is mounted on the first or second stabilizer bar to give one or more of the plurality of single-axis or multi-axis connectors on the first or second stabilizer bar a longitudinal degree of freedom of motion or to lock them.

[0011] In some embodiments of this disclosure, a method for stabilizing the spine is disclosed, the method comprising positioning a patient requiring spinal stabilization, wherein a plurality of spinal rods have been fixed to the patient's spine; connecting a stabilizer assembly of a spinal orthopedic device to at least one of the plurality of spinal rods, wherein the stabilizer assembly includes: a hinge including: a first rod support plate; a second rod support plate rotatably connected to the first rod support plate to allow the stabilizer assembly to have coronal plane motion degrees of freedom or sagittal plane motion degrees of freedom, or both; and a locking mechanism for locking the first rod support plate and the second rod support plate. The system comprises: a rod support plate locked at a desired angle; a first stabilizer bar connected to the first rod support plate; a second stabilizer bar connected to the second rod support plate; and a plurality of single-axis or multi-axis connectors, each movably connected to the first or second stabilizer bar and movably connected to a first or second spinal bar fixed to the spine; and stabilizing the spine in a desired spinal morphology; wherein the stabilizer assembly can be connected to the first or second spinal bar 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 support plates at the desired angle includes one or more screws. In another aspect, the first stabilizer bar is connected to the first rod support plate via a first threaded portion of the first stabilizer bar. In another aspect, the second stabilizer bar is connected to the second rod support plate via a second threaded portion of the second stabilizer bar. In yet another aspect, each single-axis or multi-axis connector is movably connected to the first or second stabilizer bar via one or more adjusting nuts or one or more locking pins. In another aspect, each multi-axis connector can be locked onto the first or second stabilizer bar and can be angledly locked onto the first or second stabilizer bar by two or more adjusting nuts. In another aspect, each single-axis or multi-axis connector can be movably connected to the first or second axial rod via one or more components, each component including a groove for receiving the first or second axial rod and can be locked in place by one or more screws. In another aspect, the first stabilizer bar is rotatably connected to the first rod support plate to give the first stabilizer bar coronal or sagittal degrees of freedom, or both; or the second stabilizer bar is rotatably connected to the second rod support plate to give the second stabilizer bar coronal or sagittal degrees of freedom, or both; and the first stabilizer bar has a locking mechanism for locking it in a desired position, or the second stabilizer bar has a locking mechanism for locking it in a desired position. In another aspect, the first or second stabilizer bar is threaded, and adjusting nuts are mounted on the first or second stabilizer bar to give one or more single-axis or multi-axis connectors on the first or second stabilizer bar longitudinal degrees of freedom or lock them.In another aspect, the method further includes connecting the stabilizer assembly to at least one of a plurality of spinal rods arranged in a specific orientation, such that the hinges have coronal plane motion degrees of freedom, sagittal plane motion degrees of freedom, or a combination of coronal and sagittal plane motion degrees of freedom.

[0012] In some embodiments of this disclosure, an operating lever for use with a spinal correction device is disclosed. The operating lever includes: a handle located at a proximal end of the operating lever; a rod body fixed to the handle; and a connection mechanism fixed to the rod body at a distal end of the operating lever. The operating lever is configured to be hinged to the spinal correction device, which includes: a stabilizer assembly comprising: the hinge, the hinge including: a first rod support plate; a second rod support plate rotatably connected to the first rod support plate to allow the stabilizer assembly to have coronal or sagittal degrees of freedom, or both; a locking mechanism for locking the first and second rod support plates at desired angles; a first stabilizing rod connected to the first rod support plate; and a second stabilizing rod connected to the second rod support plate. The stabilizer assembly is connectable 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. In one aspect, the rod is straight. In another aspect, the rod is curved. In yet another aspect, the rod has a circular, elliptical, triangular, square, pentagonal, hexagonal, or other polygonal cross-section. In yet another aspect, the connecting mechanism includes a threaded groove configured to receive a threaded bolt.

[0013] In some embodiments of this disclosure, a kit is disclosed comprising an operating lever for use with a spinal correction device, the operating lever comprising: a handle located at a proximal end of the operating lever; a lever body fixed to the handle; and a connection mechanism fixed to the lever body at a distal end of the operating lever; wherein the operating lever is configured for hinged connection with the spinal correction device; and the spinal correction device comprising: a stabilizer assembly including: the hinge, the hinge including: a first lever support plate; and a second lever support plate, the second lever support plate being capable of... The stabilizer assembly is rotatably connected to the first rod support plate to give it coronal or sagittal degrees of freedom, or both; a locking mechanism for locking the first and second rod support plates at desired angles; a first stabilizing rod connected to the first rod support plate; and a second stabilizing rod connected to the second rod support plate; wherein the stabilizer assembly is connectable 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. In one aspect, the rod body of the operating rod is straight. In another aspect, the rod body of the operating rod is curved. In yet another aspect, the rod body of the operating rod has a circular, elliptical, triangular, square, pentagonal, hexagonal, or other polygonal cross-section.

[0014] In other embodiments of this disclosure, an operating clamp for use with a spinal correction device is disclosed, the operating clamp comprising: two clamp arms rotatably connected to each other, wherein the two clamp arms engage with each other at their proximal ends by a disengageable ratchet mechanism, and each clamp arm includes a clamping surface at its distal end; wherein the operating clamp is configured to engage with a stabilizing bar of the spinal correction device and with a spinal bar, wherein the spinal correction device includes: a stabilizer assembly, the stabilizer assembly including: a hinge including: a first bar support plate; a second bar support plate; The second rod support plate is rotatably connected to the first rod support plate to give the stabilizer assembly coronal or sagittal degrees of freedom, or both; a locking mechanism for locking the first and second rod support plates at a desired angle; a first stabilizing rod connected to the first rod support plate; and a second stabilizing rod connected to the second rod support plate; and wherein the stabilizer assembly is connectable to a first spinal bar or a second spinal bar fixed to the spine to stabilize the spine and prevent compression, traction, or displacement of the spinal cord during spinal correction. In one aspect, the clamping surface of each clamp arm includes a first groove for engaging with the first or second stabilizing rod and a second groove for engaging with the first or second spinal bar.

[0015] In other embodiments of this disclosure, an operating clamp for use with a spinal correction device is disclosed, the operating clamp comprising: two clamp arms rotatably connected to each other, wherein the two clamp arms engage with each other at a proximal end of the operating clamp via a disengaged ratchet mechanism, and each clamp arm includes a clamping surface at a distal end of the operating clamp; wherein the operating clamp is configured to engage with a stabilizing bar of the spinal correction device and with a spinal bar; and the spinal correction device comprising: a stabilizer assembly, the stabilizer assembly including: a hinge including: a first bar support plate; and a second bar support plate. The second rod support plate is rotatably connected to the first rod support plate to give the stabilizer assembly coronal or sagittal degrees of freedom, or both; a locking mechanism for locking the first and second rod support plates at a desired angle; a first stabilizing rod connected to the first rod support plate; and a second stabilizing rod connected to the second rod support plate; and wherein the stabilizer assembly is connectable to a first spinal bar or a second spinal bar fixed to the spine to stabilize the spine and prevent compression, traction, or displacement of the spinal cord during spinal correction. In one aspect, the clamping surface of each clamp arm of the operating clamp includes a first groove for engaging with the first or second stabilizing rod and a second groove for engaging with the first or second spinal bar.

[0016] In other embodiments of this disclosure, a spinal correction device is disclosed, comprising: a stabilizer assembly including: a hinge including: a first rod support plate; a second rod support plate rotatably connected to the first rod support plate to allow the stabilizer assembly to have coronal plane motion degrees of freedom or sagittal plane motion degrees of freedom or both; a locking mechanism for locking the first rod support plate and the second rod support plate at a desired angle; a first stabilizing rod connected to the first rod support plate; and a second stabilizing rod connected to the second rod support plate; wherein the first rod support plate includes a first bolt hole configured to receive a second nut bolt to connect the first stabilizing rod to the first rod support plate, and the second rod support plate includes a second bolt hole configured to receive a second nut bolt to connect the second stabilizing rod to the second rod support plate; and wherein the stabilizer assembly is connectable to a first spinal rod fixed to the spine 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.

[0017] In some embodiments of this disclosure, a single-plane clamp hinge for spinal surgery is disclosed, characterized by comprising: a dual-axis hinge including a first hinge rod support plate, a second hinge rod support plate rotatably connected to the first hinge rod support plate, a first hinge rod connected to the first hinge rod support plate, a second hinge rod connected to the second hinge rod support plate, and a first locking screw and a second locking screw for locking the first hinge rod and the second hinge rod at a desired angle; a first single-plane clamp and a second single-plane clamp, the first single-plane clamp being movably connected to the first hinge rod, and the second single-plane clamp being movably connected to the second hinge rod; a stabilizing rod, the stabilizing rod being movably connected to the first single-plane clamp and the second single-plane clamp; a first temporary spinal rod and a second temporary spinal rod, the first temporary spinal rod being movably connected to the first single-pole clamp, and the second temporary spinal rod being movably connected to the second single-plane clamp. In one aspect, each of the first single-pole clamp and the second single-pole clamp includes a spring-loaded snap-fit ​​hinge clamp and a hinge rod locking nut. In another aspect, each of the first and second unipolar clamps includes a spring-loaded snap-fit ​​temporary spine bar clamp and a temporary spine bar locking nut. In another aspect, each of the first and second unipolar clamps includes an integrated locking latch and a stabilizer bar locking bolt. In another aspect, the first hinge bar is configured to be movably connected to a first spring-loaded snap-fit ​​hinge bar clamp of the first uniplane hinge clamp, and the second hinge bar is configured to be movably connected to a second spring-loaded snap-fit ​​hinge bar clamp of the second uniplane hinge clamp. In another aspect, the first temporary spine bar is configured to be movably connected to a first spring-loaded snap-fit ​​temporary spine bar clamp of the first uniplane hinge clamp, and the second temporary spine bar is configured to be movably connected to a second spring-loaded snap-fit ​​temporary spine bar clamp of the second uniplane hinge clamp. In another aspect, the stabilizer bar is configured to be movably connected to a first integrated locking latch of the first uniplane hinge clamp and a second integrated locking latch of the second uniplane hinge clamp.

[0018] In other embodiments of this disclosure, a single-plane clamp hinge kit is disclosed, comprising a single-plane hinge clamp, the single-plane hinge clamp comprising: a dual-axis hinge, the dual-axis hinge comprising a first hinge rod support plate, a second hinge rod support plate rotatably connected to the first hinge rod support plate, a first hinge rod connected to the first hinge rod support plate, a second hinge rod connected to the second hinge rod support plate, and a first locking screw and a second locking screw for locking the first hinge rod and the second hinge rod at a desired angle; a first single-plane clamp and a second single-plane clamp, the first single-plane clamp being movably connected to the first hinge rod, and the second single-plane clamp being movably connected to the second hinge rod; a stabilizing rod, the stabilizing rod being movably connected to the first single-plane clamp and the second single-plane clamp; a first temporary spindle rod and a second temporary spindle rod, the first temporary spindle rod being movably connected to the first single-pole clamp, and the second temporary spindle rod being movably connected to the second single-plane clamp; and one or more tools for manipulating the single-plane clamp hinge. In one aspect, each of the first and second unipolar clamps includes a spring-loaded snap-fit ​​hinge clamp and a hinge rod locking nut. In another aspect, each of the first and second unipolar clamps includes a spring-loaded snap-fit ​​temporary spine rod clamp and a temporary spine rod locking nut. In yet another aspect, each of the first and second unipolar clamps includes an integrated locking latch and a stabilizer rod locking bolt. In yet another aspect, the first hinge rod is configured to be movably connected to a first spring-loaded snap-fit ​​hinge clamp of the first uniplane hinge clamp, and the second hinge rod is configured to be movably connected to a second spring-loaded snap-fit ​​hinge clamp of the second uniplane hinge clamp. In yet another aspect, the first temporary spine rod is configured to be movably connected to a first spring-loaded snap-fit ​​temporary spine rod clamp of the first uniplane hinge clamp, and the second temporary spine rod is configured to be movably connected to a second spring-loaded snap-fit ​​temporary spine rod clamp of the second uniplane hinge clamp. In another embodiment, the stabilizer bar is configured to be movably connected to a first integrated locking tab of the first single-plane hinge clamp and a second integrated locking tab of the second single-plane hinge clamp.

[0019] In other embodiments of this disclosure, a method of using a single-plane hinge fixture is disclosed, the method comprising: providing a single-plane hinge fixture, the single-plane hinge fixture comprising: a dual-axis hinge, the dual-axis hinge comprising a first hinge rod support plate, a second hinge rod support plate rotatably connected to the first hinge rod support plate, a first hinge rod connected to the first hinge rod support plate, a second hinge rod connected to the second hinge rod support plate, and a first locking screw and a second locking screw for locking the first hinge rod and the second hinge rod at a desired angle; a first single-plane fixture and a second single-plane fixture, the first single-plane fixture being movably connected to the first hinge rod, and the second single-plane fixture being movably connected to the second hinge rod; a stabilizing rod, the stabilizing rod being movably connected to the first single-plane fixture and the second single-plane fixture; and a first temporary spinal rod and a second temporary spinal rod, the first temporary spinal rod being movably connected to the first single-pole fixture, and the second temporary spinal rod being movably connected to the second single-plane fixture; and using the single-plane hinge fixture to perform spinal surgery. In one aspect, each of the first and second unipolar clamps includes a spring-loaded snap-fit ​​hinge clamp and a hinge rod locking nut. In another aspect, each of the first and second unipolar clamps includes a spring-loaded snap-fit ​​temporary spine rod clamp and a temporary spine rod locking nut. In yet another aspect, each of the first and second unipolar clamps includes an integrated locking latch and a stabilizer rod locking bolt. In yet another aspect, the first hinge rod is configured to be movably connected to a first spring-loaded snap-fit ​​hinge clamp of the first uniplane hinge clamp, and the second hinge rod is configured to be movably connected to a second spring-loaded snap-fit ​​hinge clamp of the second uniplane hinge clamp. In yet another aspect, the first temporary spine rod is configured to be movably connected to a first spring-loaded snap-fit ​​temporary spine rod clamp of the first uniplane hinge clamp, and the second temporary spine rod is configured to be movably connected to a second spring-loaded snap-fit ​​temporary spine rod clamp of the second uniplane hinge clamp. In another embodiment, the stabilizer bar is configured to be movably connected to a first integrated locking tab of the first single-plane hinge clamp and a second integrated locking tab of the second single-plane hinge clamp.

[0020] In other embodiments of this disclosure, a single-plane clamp hinge for spinal surgery is disclosed, the single-plane clamp hinge comprising: a gear-type dual-axis hinge including four gears, a first hinge rod connected to one or more of the four gears, a second hinge rod connected to one or more of the four gears, and a plurality of locking screws for locking the four gears at a desired angle; a first single-plane clamp and a second single-plane clamp, the first single-plane clamp being movably connected to the first hinge rod, and the second single-plane clamp being movably connected to the second hinge rod; a stabilizing rod being movably connected to the first single-plane clamp and the second single-plane clamp; and a first temporary spinal rod and a second temporary spinal rod, the first temporary spinal rod being movably connected to the first single-pole clamp, and the second temporary spinal rod being movably connected to the second single-plane clamp. In one aspect, each of the first single-pole clamp and the second single-pole clamp includes a spring-loaded snap-fit ​​hinge clamp and a hinge rod locking nut. In another aspect, each of the first and second unipolar clamps includes a spring-loaded snap-fit ​​temporary spine bar clamp and a temporary spine bar locking nut. In another aspect, each of the first and second unipolar clamps includes an integrated locking latch and a stabilizer bar locking bolt. In another aspect, the first hinge bar is configured to be movably connected to a first spring-loaded snap-fit ​​hinge bar clamp of the first uniplane hinge clamp, and the second hinge bar is configured to be movably connected to a second spring-loaded snap-fit ​​hinge bar clamp of the second uniplane hinge clamp. In another aspect, the first temporary spine bar is configured to be movably connected to a first spring-loaded snap-fit ​​temporary spine bar clamp of the first uniplane hinge clamp, and the second temporary spine bar is configured to be movably connected to a second spring-loaded snap-fit ​​temporary spine bar clamp of the second uniplane hinge clamp. In another aspect, the stabilizer bar is configured to be movably connected to a first integrated locking latch of the first uniplane hinge clamp and a second integrated locking latch of the second uniplane hinge clamp.

[0021] In other embodiments of this disclosure, a single-plane clamp hinge kit is disclosed, comprising a single-plane clamp hinge including: a gear-type dual-axis hinge including four gears, a first hinge rod connected to one or more of the four gears, a second hinge rod connected to one or more of the four gears, and a plurality of locking screws for locking the four gears at a desired angle; a first single-plane clamp and a second single-plane clamp, the first single-plane clamp being movably connected to the first hinge rod, and the second single-plane clamp being movably connected to the second hinge rod; a stabilizing rod being movably connected to the first single-plane clamp and the second single-plane clamp; a first temporary spine rod and a second temporary spine rod, the first temporary spine rod being movably connected to the first single-pole clamp, and the second temporary spine rod being movably connected to the second single-plane clamp; and one or more tools for manipulating the single-plane clamp hinge. In one aspect, each of the first single-pole clamp and the second single-pole clamp includes a spring-loaded snap-fit ​​hinge clamp and a hinge rod locking nut. In another aspect, each of the first and second unipolar clamps includes a spring-loaded snap-fit ​​temporary spine bar clamp and a temporary spine bar locking nut. In another aspect, each of the first and second unipolar clamps includes an integrated locking latch and a stabilizer bar locking bolt. In another aspect, the first hinge bar is configured to be movably connected to a first spring-loaded snap-fit ​​hinge bar clamp of the first uniplane hinge clamp, and the second hinge bar is configured to be movably connected to a second spring-loaded snap-fit ​​hinge bar clamp of the second uniplane hinge clamp. In another aspect, the first temporary spine bar is configured to be movably connected to a first spring-loaded snap-fit ​​temporary spine bar clamp of the first uniplane hinge clamp, and the second temporary spine bar is configured to be movably connected to a second spring-loaded snap-fit ​​temporary spine bar clamp of the second uniplane hinge clamp. In another aspect, the stabilizer bar is configured to be movably connected to a first integrated locking latch of the first uniplane hinge clamp and a second integrated locking latch of the second uniplane hinge clamp.

[0022] In other embodiments of this disclosure, a method of using a single-plane hinge clamp is disclosed, the method comprising: providing a single-plane hinge clamp comprising: a gear-type dual-axis hinge including four gears, a first hinge rod connected to one or more of the four gears, a second hinge rod connected to one or more of the four gears, and a plurality of locking screws for locking the four gears at a desired angle; a first single-plane clamp and a second single-plane clamp, the first single-plane clamp being movably connected to the first hinge rod, and the second single-plane clamp being movably connected to the second hinge rod; a stabilizing rod being movably connected to the first single-plane clamp and the second single-plane clamp; and a first temporary spinal rod and a second temporary spinal rod, the first temporary spinal rod being movably connected to the first single-pole clamp, and the second temporary spinal rod being movably connected to the second single-plane clamp; and using the single-plane hinge clamp to perform spinal surgery. In one aspect, each of the first single-pole clamp and the second single-pole clamp includes a spring-loaded snap-fit ​​hinge clamp and a hinge rod locking nut. In another aspect, each of the first and second unipolar clamps includes a spring-loaded snap-fit ​​temporary spine bar clamp and a temporary spine bar locking nut. In another aspect, each of the first and second unipolar clamps includes an integrated locking latch and a stabilizer bar locking bolt. In another aspect, the first hinge bar is configured to be movably connected to a first spring-loaded snap-fit ​​hinge bar clamp of the first uniplane hinge clamp, and the second hinge bar is configured to be movably connected to a second spring-loaded snap-fit ​​hinge bar clamp of the second uniplane hinge clamp. In another aspect, the first temporary spine bar is configured to be movably connected to a first spring-loaded snap-fit ​​temporary spine bar clamp of the first uniplane hinge clamp, and the second temporary spine bar is configured to be movably connected to a second spring-loaded snap-fit ​​temporary spine bar clamp of the second uniplane hinge clamp. In another aspect, the stabilizer bar is configured to be movably connected to a first integrated locking latch of the first uniplane hinge clamp and a second integrated locking latch of the second uniplane hinge clamp.

[0023] In one embodiment of this disclosure, a repositioning device correction system for spinal surgery includes: two single-plane clamps; a repositioning rod having opposing threaded ends configured to connect to each of the two single-plane clamps; a stabilizing rod configured to connect to each of the two single-plane clamps; two temporary spinal rods, each temporary spinal rod configured to connect to a corresponding single-plane clamp; and an adjustable force compression device including a constant force cable configured to connect to each of the two single-plane clamps. In one aspect, each of the two single-plane clamps includes a stabilizing rod locking bolt and a stabilizing rod locking nut for connecting the stabilizing rod to the single-plane clamp. In another aspect, each of the two single-plane clamps includes an open clamp, a spring-loaded latch, and a temporary spinal locking nut for connecting one of the temporary spinal rods to the single-plane clamp. In another aspect, the adjustable force compression device further includes an adjustable-length mechanical base connected to the constant force cable. In yet another aspect, the adjustable force compression device further includes a self-locking pump handle connected to the constant force cable. In another aspect, the adjustable force compression device also includes two constant force springs connected to the constant force cable.

[0024] In another embodiment of this disclosure, a kit for a repositioning device correction system for spinal surgery includes: two single-plane clamps; a repositioning rod having opposing pitched threaded ends configured to connect to each of the two single-plane clamps; a stabilizing rod configured to connect to each of the two single-plane clamps; two temporary spinal rods, each temporary spinal rod configured to connect to a corresponding single-plane clamp; an adjustable force compression device including a constant force cable configured to connect to each of the two single-plane clamps; and one or more tools for assembling or operating the repositioning device correction system. In one aspect, each of the two single-plane clamps includes a stabilizing rod locking bolt and a stabilizing rod locking nut for connecting the stabilizing rod to the single-plane clamp. In another aspect, each of the two single-plane clamps includes an open clamp, a spring-loaded latch, and a temporary spinal locking nut for connecting one of the temporary spinal rods to the single-plane clamp. In yet another aspect, the adjustable force compression device further includes an adjustable-length mechanical base connected to the constant force cable. In another aspect, the adjustable force compression device further includes a self-locking pump handle connected to the constant force cable. In yet another aspect, the adjustable force compression device also includes two constant force springs connected to the constant force cable.

[0025] In another embodiment of this disclosure, a method of using a repositioning device correction system for spinal surgery includes: positioning a patient requiring spinal surgery; providing the repositioning device correction system, which includes two single-plane clamps; a repositioning rod having opposing threaded ends configured to connect to each of the two single-plane clamps; a stabilizing rod configured to connect to each of the two single-plane clamps; two temporary spinal rods, each temporary spinal rod configured to connect to a corresponding single-plane clamp; and an adjustable force compression device including a constant force cable configured to connect to each of the two single-plane clamps; and performing spinal surgery using the repositioning device correction system. In one aspect, each of the two single-plane clamps includes a stabilizing rod locking bolt and a stabilizing rod locking nut for connecting the stabilizing rod to the single-plane clamp. In another aspect, each of the two single-plane clamps includes an open clamp, a spring-loaded latch, and a temporary spinal locking nut for connecting one of the temporary spinal rods to the single-plane clamp. In yet another aspect, the adjustable force compression device further includes an adjustable-length mechanical base connected to the constant force cable. In another aspect, the adjustable force compression device further includes a self-locking pump handle connected to the constant force cable. In yet another aspect, the adjustable force compression device also includes two constant force springs connected to the constant force cable. Attached Figure Description

[0026] To more fully understand the features and advantages of the present invention, reference is now made to the detailed description of the invention and the accompanying drawings, as follows.

[0027] Figure 1A , 1B 1C illustrates a stabilizer component.

[0028] Figure 2A Another stabilizer component is shown.

[0029] Figure 2B , 2C And 2D shows Figure 2A A top view of the stabilizer components shown.

[0030] Figure 2E , 2F And 2G showed Figure 2A A 3D view of the stabilizer assembly shown.

[0031] Figure 2H This shows how to adjust the adjusting nut using a wrench. Figure 2A The view shown is of the stabilizer components.

[0032] Figure 2I It shows Figure 2A Side view of the stabilizer component shown.

[0033] Figure 3A A single-axis connector is shown.

[0034] Figure 3B Another single-axis connector is shown.

[0035] Figure 3C Another type of uniaxial connector is shown.

[0036] Figure 3D A cross-section of a multi-axis connector is shown.

[0037] Figure 3E , 3F 3G and 3H show Figure 3D A three-dimensional view of the multi-axis connector shown.

[0038] Figure 3I A perspective view of another multi-axis connector is shown.

[0039] Figure 3J A perspective view of another multi-axis connector is shown.

[0040] Figure 4A , 4B And 4C shows Figure 1A , 1B The stabilizer assembly shown in 1C is connected to a spinal rod, wherein the spinal rod is fixed to a simulated spine.

[0041] Figure 5A and 5B It shows Figure 1A , 1B A schematic diagram of the stabilizer assembly and the operating assembly shown in Figure 1C when used together.

[0042] Figure 6A , 6B 6C and 6C are respectively used Figure 2A The diagram shows the stabilizer assembly performing coronal plane control correction, sagittal plane control correction, and longitudinal correction.

[0043] Figure 6D and 6E For use Figure 2A The diagram shows the stabilizer assembly performing two different sagittal plane control corrections. Figure 6F It shows Figure 6E The top view shown is of the sagittal plane control correction.

[0044] Figure 6G , 6H 6I and 6J show Figure 2I The stabilizer components are shown from multiple angles.

[0045] Figure 7A For use Figure 2I The diagram shows a stabilizer assembly performing coronal plane control correction.

[0046] Figure 7B For use Figure 2I The diagram shows a stabilizer assembly performing sagittal plane control correction.

[0047] Figure 7C For use Figure 2I The diagram shows the stabilizer assembly undergoing longitudinal correction.

[0048] Figure 7D It shows Figure 2I The stabilizer assembly shown has a hinge located at the apex of the spinal deformation, where VCR has been applied.

[0049] Figure 7E and 7F It shows how to Figure 2I The hinge of the stabilizer assembly shown is... Figure 5A and 5B The operating components shown are used together for spinal correction.

[0050] Figure 7G It shows how to use Figure 2I The hinge of the stabilizer assembly shown is used for stabilization. Figure 7E and 7F The spinal correction shown.

[0051] Figure 8 A flowchart of one embodiment of the present invention is shown.

[0052] Figure 9A The control stick, control clamp, and stabilizer assembly are shown.

[0053] Figure 9B The operating lever is shown in a hinged state ready to be connected to the stabilizer assembly.

[0054] Figure 9C A side view of the operating clamp connected to the stabilizer bar and the spine bar is shown.

[0055] Figure 9D The distal end of the operating clamp connected to the stabilizer bar and the spindle bar is shown.

[0056] Figure 9E The rod support plate of the stabilizer assembly is shown.

[0057] Figure 9F The rod-bearing plate of the stabilizer assembly connected at the hinge is shown.

[0058] Figure 10 An embodiment of a single-plane clamp hinge is shown.

[0059] Figure 11A , Figure 11B and Figure 11C A dual-axis hinge is shown.

[0060] Figure 12A and Figure 12B A view of a single-plane fixture is shown.

[0061] Figure 13 The bilateral pedicle screws inserted into the vertebrae are shown.

[0062] Figure 14 This is a schematic diagram of spinal resection.

[0063] Figure 15 A single-plane clamp hinge is shown, fixed to each of the two temporary spinal rods.

[0064] Figure 16 A stabilizer bar spanning the cut-off gap is shown, secured using locking bolts.

[0065] Figure 17 A dual-axis hinge is shown using a hinge clamp with a single-plane clamp for placement and fixation.

[0066] Figure 18A and Figure 18B The hinge position lines are shown at two different locations.

[0067] Figure 19 The hinge position lines are shown at six different locations.

[0068] Figure 20 This is a schematic diagram of measuring the resection gap and spine before reduction in the midsagittal plane.

[0069] Figure 21 The spine with a single-plane clamp hinge is shown before repositioning.

[0070] Figure 22 The image shows a spine with a single-plane clamp hinge installed immediately after repositioning.

[0071] Figure 23 This is a schematic diagram of measuring the resection gap and spine immediately after reduction in the midsagittal plane.

[0072] Figure 24 A top view of the component is shown, with the final rod positioned on the left.

[0073] Figure 25 This is a schematic diagram of using a fusion device to support the anterior column of the excised area.

[0074] Figure 26This is a diagram showing how to fix the final rod to the right side after removing the single-plane clamp hinge and temporary spine rod.

[0075] Figure 27A This is a schematic diagram showing the hinge position line located at the posterior edge of the vertebral body during the pre-reduction phase. Figure 27B The spine is shown immediately after repositioning.

[0076] Figure 28A This is a schematic diagram showing the HPL located at the anterior 1 / 3 of the vertebral body during the pre-reduction phase. Figure 28B The spine is shown immediately after repositioning.

[0077] Figure 29 A table is shown, listing the percentage change in length (positive) or length (negative) at the cut-off gap at different hinge positions after resetting using a 30mm hinge.

[0078] Figure 30 A table is shown, listing the percentage change in length (positive) or length (negative) of the cut-off gap at different hinge positions after resetting using a 15mm hinge.

[0079] Figure 31 A table is shown, listing the percentage change in length (positive) or length (negative) at the cut-off gap at different hinge positions after resetting using a 30mm hinge.

[0080] Figure 32 Another embodiment of a single-plane clamp hinge is shown.

[0081] Figure 33 A stable reset threaded rod is shown.

[0082] Figure 34A , Figure 34B , Figure 34C and Figure 34D Various views of a gear-type dual-axis hinge are shown.

[0083] Figure 35A and Figure 35B A view of a single-plane fixture is shown.

[0084] Figure 36A , Figure 36B and Figure 36C The gear-type biaxial hinge is shown in various stages of reset.

[0085] Figure 37A and Figure 37B This is a schematic diagram of using a vertebral body support fusion device as a hinge.

[0086] Figure 38A reduction device (RD) correction system was demonstrated, which includes two single-plane clamps, a reduction rod with a threaded end having a pitch relative to the other end, a stabilizing rod, two temporary spinal rods, an adjustable interbody fusion device, and a constant force compression device.

[0087] Figure 39 The front view of the single-plane fixture is shown.

[0088] Figure 40 A side view of a single-plane fixture is shown.

[0089] Figure 41 A reset lever is shown, which consists of a lever with opposing threaded ends, two lockable differential threaded reset bolts, and a knob integrated into the reset lever.

[0090] Figure 42 The front view of the constant force compression device is shown.

[0091] Figure 43 The placement of bilateral kyphotic rods for inducing angular kyphosis of the thoracolumbar spine is demonstrated.

[0092] Figure 44 This is a diagram showing two temporary spinal rods fixed to the right side, with one temporary spinal rod located on the head side and the other on the tail side.

[0093] Figure 45 This is a schematic diagram of the placement of a single-plane clamp, where each clamp is fixed to the corresponding temporary spinal rod on the right head and tail sides, respectively.

[0094] Figure 46 This is a diagram illustrating how a stabilizer bar is secured across the apex using locking bolts.

[0095] Figure 47 This is a schematic diagram of using a locking bolt across the apex to secure the reset rod.

[0096] Figure 48 A schematic diagram illustrating the complete removal of the entire apical vertebral body.

[0097] Figure 49 This is a schematic diagram of measurements of the resection space and spine in the midsagittal plane before reduction.

[0098] Figure 50 This diagram illustrates the positioning of the anterior column support interbody fusion device and the secure fixing of the constant force cable.

[0099] Figure 51 The spinal segment was shown to be fixed by a repositioning device.

[0100] Figure 52The diagram shows the position of the interbody fusion cage and the connection of the constant force cable that acts as the repositioning hinge after spinal resection.

[0101] Figure 53 The spine was shown using the repositioning device immediately after the repositioning procedure.

[0102] Figure 54 This is a schematic diagram showing the measurement of the resection gap and spine in the midsagittal plane immediately after repositioning.

[0103] Figure 55 This is a top view of the structure when the final member is on the left.

[0104] Figure 56 This is a diagram showing the final rod being fixed on the right side after the repositioning device and temporary spinal rod have been removed.

[0105] Figure 57 Table showing the percentage change in the resection space at three different interbody fusion cage heights.

[0106] Figure 58 The device for reduction before pedicle subtraction osteotomy (PSO) is shown.

[0107] Figure 59 A reset device for PSO after reset is demonstrated.

[0108] Figure 60 An external hinge reduction device is demonstrated for correcting kyphosis caused by burst fracture of the vertebral body before reduction.

[0109] Figure 61 An external hinge reduction device is demonstrated for correcting kyphosis after vertebral burst fracture.

[0110] Figure 62 A rear view of a modified external hinge reduction device for correcting severe kyphosis and scoliosis before reduction is shown.

[0111] Figure 63 The image shows a modified external hinge reduction device for correcting severe kyphotic scoliosis before reduction, viewed from the head side.

[0112] Figure 64 The image shows a rear view of a modified external hinge repositioning device for correcting severe kyphosis and scoliosis after repositioning.

[0113] Figure 65 This image shows a modified external hinge repositioning device for correcting severe kyphotic scoliosis after repositioning, viewed from the cephalometric side.

[0114] Figure 66 A flowchart illustrating one embodiment of the method of the present invention is shown. Detailed Implementation

[0115] The following describes an illustrative implementation of the system of this application. For clarity, not all features of the actual implementation are described in this specification. It should be understood, of course, that many implementation-specific decisions must be made in the development of any such actual implementation to achieve the developer's specific goals, such as compliance with system-related and business-related constraints, which will vary depending on the implementation. Furthermore, it should be understood that such development work can be complex and time-consuming, but remains routine work for those skilled in the art who benefit from this disclosure.

[0116] In this specification, since the various devices are shown in the accompanying drawings, reference can be made to the spatial relationships between multiple components and the spatial orientations of multiple aspects of the components. However, as those skilled in the art will recognize upon a complete reading of this application, the devices, components, apparatuses, etc., described herein can be positioned in any desired orientation. Therefore, 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 orientations of multiple aspects of these components should be understood as describing the relative relationships between such components or the spatial orientations of multiple aspects of these components, since the devices described herein can be positioned in any desired orientation.

[0117] Figure 1A and 1B An embodiment of the invention is shown, which prevents the spinal cord from being compressed, stretched, or displaced during vertebrectomy, namely stabilizer assembly 100. Figure 1A This is a side view. Figure 1B This is a top view. The stabilizer assembly 100 includes a hinge 105 comprising rod support plates 110 and 115 and a hinge locking mechanism 120. Rod support plates 115 are rotatably connected to rod support plates 110 to achieve coronal or sagittal plane degrees of freedom, or both, depending on the orientation of the stabilizer assembly relative to the spine. The hinge locking mechanism 120 is used to lock rod support plates 110 and 115 at a desired angle. Stabilizer bars 125 and 130 are connected to rod support plates 110 and 115 via, for example, threaded portions of stabilizer bars 125 and 130 near the hinge 105. Stabilizer bars 125, 130, or both are threaded, and adjusting nuts are mounted on stabilizer bars 125, 130, or both to achieve longitudinal degree of freedom.

[0118] Figure 1C The stabilizer assembly 100 of the present invention, connected to spinal rods 135 and 140, is shown. These spinal rods may be straight or curved. Figure 1C Hinge 105 is shown, comprising rod support plates 110 and 115, locking mechanism 120, stabilizing bars 125 and 130, and four connectors 145a, 145b, 145c, and 145d. Connectors 145a, 145b, 145c, and 145d are connected to spindle rods 135 and 140. Connectors 145a, 145b, 145c, and 145d represent various embodiments of connectors in this invention, including single-axis and multi-axis connectors as described herein.

[0119] Figure 2A Another embodiment of the invention is illustrated, which prevents compression, traction, or displacement of the spinal cord during vertebrectomy, namely stabilizer assembly 200. The stabilizer assembly includes a hinge 205 configured to allow the stabilizer assembly to have coronal or sagittal degrees of freedom, or both, depending on the orientation of the stabilizer assembly relative to the spine. Rod support plates 210 and 215 are rotatably connected to allow coronal or sagittal degrees of freedom, 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 support plates 210 and 215 at a desired angle. Stabilizer bars 225 and 230 are threaded on at least a portion of their respective length directions and are connected to the rod support plates 210 and 215 via, for example, threaded portions on the ends of the stabilizer bars 225 and 230 near the hinge 205. Stabilizer bars 225 and 230 are rotatably connected to bar support plates 210 and 215, which have degrees of freedom of movement about rotation axes perpendicular to the plane formed when these axes are at a 180-degree angle to the bar support plates 210 and 215. Locking mechanisms 232 and 234 are used to lock stabilizer bars 225 and 230 in desired positions, respectively. Stabilizer bars 225 and 230 have threaded structures and are equipped with exemplary adjusting nuts 235a, 235b, 235c, and 235d to allow a connector (not shown) to move longitudinally along stabilizer bars 225 and 230, thereby achieving longitudinal degrees of freedom of movement along stabilizer bars 225 and 230. Adjusting nuts 235a, 235b, 235c, and 235d can be used to fix the connector to specific positions on stabilizer bars 225 and 230.

[0120] Figure 2B A top view of the stabilizer assembly 200 is shown, in which the rod bearing plates 210 and 215 of the hinge 205 are at a 180-degree angle. Figure 2C and 2D Top views of stabilizer assembly 200 are shown, with the rod bearing plates 210 and 215 of hinge 205 at different angles, to exemplify the coronal plane degrees of freedom provided by hinge 205.

[0121] Figure 2EA side view of the stabilizer assembly 200 is shown, in which the rod bearing plates 210 and 215 of the hinge 205 are at a 180-degree angle, and the stabilizer bars 225 and 230 are aligned with each other. Figure 2F and 2G A side view of the stabilizer assembly 200 is shown, in which the rod bearing plates 210 and 215 of the hinge 205 are at a 180-degree angle, while the stabilizer bars 225 and 230 are at different angles, to exemplarily demonstrate the sagittal plane degrees of freedom of the stabilizer bars 225 and 230.

[0122] Figure 2H A side view of the stabilizer assembly 200 is shown, in which the rod bearing plates 210 and 215 of the hinge 205 are at a 180-degree angle, the stabilizer bars 225 and 230 are aligned with each other, and a wrench 240 is used to adjust the position of the adjusting nut 235 so that it moves longitudinally along the stabilizer bar 230, thereby positioning the connector (not shown) on the stabilizer bar 230.

[0123] Figure 2I A 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, and the stabilizer bars 225 and 230 are aligned with each other, having eight exemplary adjusting nuts 235a, 235b, 235c, 235d, 235e, 235f, 235g, and 235h, four of which are provided on each of the stabilizer bars 225 and 230. The adjusting nuts can be made of any material, such as metal, polymer, composite material, etc.

[0124] Figure 3A A uniaxial connector 300 according to the present invention is shown. Figure 3A A uniaxial connector 300 of the present invention is shown. A plurality of connectors 300 may be movably connected to one or more of stabilizer bars 125 and 130 (not shown) via the upper end 302 of each connector 300. Each connector 300 may be positioned and locked at any position on the stabilizer bar 125 or 130 by, for example, a set screw 304. Each connector 300 may be movably connected at its lower end 306 to a spinal rod (not shown) fixed to the spine by, for example, a bone screw. Each connector 300 may be positioned and locked at any position on the spinal rod by, for example, a set screw 308.

[0125] Figure 3BAnother uniaxial connector 310 of the present invention is shown. A plurality of connectors 310 may be movably connected to one or both of the stabilizer bars 125 and 130 via their upper ends 312. Each connector 310 may be positioned and locked at any position on the stabilizer bar 125 or 130 by, for example, a set screw 314. Each connector 310 may be movably connected to a spinal rod (not shown) fixed to the spine via its lower end 316 by, for example, a bone screw. Each connector 310 may be positioned and locked at any position on the spinal rod by, for example, a set screw 318.

[0126] Figure 3C Another uniaxial connector 320 of the present invention is shown. A plurality of connectors 320 may be movably connected to one or both of stabilizer bars 125 and 130 (not shown) via their upper ends 322. Each connector 320 may be positioned at any position on stabilizer bar 125 or 130 (not shown) by, for example, a locking pin (not shown) passing through a hole 324 to hold it on stabilizer bar 125 or 130 (not shown). Each connector 320 may be movably connected to a spinal rod (not shown) fixed to the spine via its lower end 326 by, for example, a bone screw. Each connector 320 may be positioned at any position on the spinal rod and locked by, for example, a set screw 328.

[0127] Figure 3D A cross-sectional view of a multi-axis connector 340 of the present invention is shown, while Figure 3E , 3FFigures 3G and 3H show perspective views of the multi-axis connector 340 of the present invention, each illustrating one or more features of the multi-axis connector 340 in different states. Each of the plurality of multi-axis connectors 340 is movably connected to one of the stabilizer bars 125 and 130 (where stabilizer bar 125 is shown and stabilizer bar 130 is not shown) by means of the upper portion 342 of each multi-axis connector 340. Each multi-axis connector 340 can be positioned and locked at any position on the stabilizer bar 125 or 130 (130 not shown) by, for example, a pair of adjusting nuts 344a and 344b (shaped to match the upper portion 342). These adjusting nuts 344a and 344b, and similar nuts at other positions on the threaded stabilizer bar 125 or 130 (130 not shown), can be locked and unlocked multiple times without damaging the threads of the adjusting nuts or the stabilizer bars. The upper part 342 of the multi-axis connector 340 is spherical and has a groove 346. The groove is shaped to accommodate either the stabilizer bar 125 or 130 (not shown). The width of the groove 346 is greater than that of the stabilizer bar 125 or 130 (not shown), and the bottom of the groove 346 includes two inclined portions 348a and 348b, which intersect at the apex 350. When the multi-axis connector 340 is positioned on the stabilizer bar 125 or 130 (not shown), the stabilizer bar 125 or 130 (not shown) is in contact with at least the apex 350, thereby ensuring that the stabilizer bar 125 or 130 (not shown) is always centered in the groove 346. The width of the groove 346 and the inclined portions 348a and 348b allow the multi-axis connector 340 to be at an adjustable angle relative to the axis of the stabilizer bar 125 or 130 (not shown) 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-axis connector 340 is in the desired position on the stabilizer bar 125 or 130 (not shown), the multi-axis connector 340 can be locked in place using adjusting nuts 344a and 344b. The stabilizing rods 125 or 130 (130 not shown) can be further secured in place using locking pins 352. The lower portion 354 of the multi-axis connector 340 has a recess 356 shaped to accommodate the spinal rod 146, which is fixed to the patient's spine (not shown). Each multi-axis connector 340 can be positioned at the desired location on the spinal rod 146 and secured in place, for example, by set screws 358.

[0128] Figure 3E The multi-axis connector 340 is shown, with adjusting nuts 344a and 344b in a non-engaged state. Figure 3FThe multi-axis connector 340 is shown from a top view, with adjusting nuts 344a and 344b in an engaged state, and the multi-axis connector 340 locked at an angle to the stabilizer bar 125. Figure 3G A multi-axis connector 340 is shown, wherein the adjusting nut 344a is engaged, the adjusting nut 344b is disengaged, and the locking pin 352 is in the position. Figure 3H A multi-axis connector 340 is shown, in which adjusting nuts 344a and 344b are both in the engaged state.

[0129] Figure 3I A perspective view of the multi-axis connector 340 is shown, including the upper part 342, the groove 346, the lower part 354, and the groove 356.

[0130] Figure 3J A perspective view of the multi-axis connector 360 is shown. The multi-axis connector 360 is similar to the multi-axis connector 340, but its bottom end 374 has two components or claws 374a and 374b. Claws 374a and 374b have grooves 376a and 376b, respectively, shaped to accommodate the spindle rod 146 (not shown), thus enabling engagement with the spindle rod 146 in two locations. The multi-axis connector 360 can be locked onto the spindle rod 146 by screws 378a and 378b. The multi-axis connector 360, engaging with the spindle rod 146 in two locations, achieves greater stability after engagement compared to single-component or single-claw multi-axis connectors (such as multi-axis connector 340). Other features of the multi-axis connector 360 are as follows: Figure 3J The upper portion 362 of the multi-axis connector 360 is shown, having a groove 366 shaped to accommodate a stabilizer bar 125 or 130 (both not shown). Components or claws similar to claws 374a and 374b may also be used in the single-axis connectors disclosed herein.

[0131] Figure 4A , 4B Figures 4C and 4C show the stabilizer assembly 100 of the present invention, which is connected to spinal rods 135 and 140, wherein spinal rods 135 and 140 are fixed to a simulated spine 400. Figure 4A and 4B Hinge 105 is shown at the apex of the spinal deformity, where VCR has been performed. Figure 4C Hinge 105 is shown at the apex of the spinal deformity, where the deformation has been corrected.

[0132] Figure 5A and 5B The scenario demonstrates the use of stabilizer assembly 100 in conjunction with operation assembly 500. Figure 5A and 5BThis demonstrates how the stabilizer assembly 100 and the operating assembly 500 can be used together for spinal correction. The operating assembly 500 includes handles 505 and 510 and a connecting rod 515. The connecting rod 515 is movably connected to the handles 505 and 510 via, for example, 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 needed. The handles 505 and 510 can be connected to spinal rods 135 and 140 to adjust the spine to the desired shape for maintenance by the stabilizer assembly. Figure 5A and 5B Operating components 500 connected to two spinal rods 135 and 140 are shown, with handles 505 and 510 in different relative positions, and the simulated spine 400 adjusted to two different desired configurations. A stabilizer assembly 100 is also shown in the figure.

[0133] Figure 6A This is a schematic diagram of coronal plane control correction using stabilizer assembly 200. Rod bearing plates 210 and 215 are positioned at the desired angle to position the simulated spine 400 into the desired shape. Figure 6B This is a schematic diagram of sagittal plane controlled correction using stabilizer assembly 200. Stabilizer bars 225 and 230 are positioned as desired to position the simulated spine 400 into the desired shape. Figure 6C This is a schematic diagram of longitudinal correction using stabilizer assembly 200. Connectors 145a, 145b, 145c, and 145d are positioned as desired using adjusting nuts 635a, 635b, 635c, 635d, 635e, and 635f.

[0134] Figure 6D This is a schematic diagram of sagittal plane controlled correction using stabilizer assembly 200. Stabilizer bars 225 and 230 are positioned as desired to position the simulated spine 400 in the desired shape. Figure 6E This is a schematic diagram of sagittal plane control correction using stabilizer assembly 200. Stabilizer assembly 200 relative to... Figure 6D The position shown is rotated by 90 degrees to give hinge 205 a sagittal plane degree of freedom of movement. The rod bearing plates 210 and 215 of hinge 205 are set at the desired angle to position the simulated spine 400 in the desired shape. Figure 6F for Figure 6E Top view of midsagittal plane control correction.

[0135] Figure 6G , 6H6I and 6J show various views of the stabilizer assembly 200, including adjusting nuts 344a, 344b, 344c and 344d (where adjusting nuts 344c and 344d are similar to adjusting nuts 344a and 344b); retaining pins 352a, 352b, 352c and 352d; multi-axis connectors 360a and 360b; and single-axis connectors 320a and 320b mounted on stabilizer arms 225 and 230, as well as a simulated spine 600. Figure 6G All these components are shown, and hinge 200 is shown at the apex of the spinal deformation, where VCR has been performed. Figure 6H The hinge 200 is shown at the apex of the spinal deformity, where the deformity has been corrected. Figure 6I It shows Figure 6G Another view (concave side view). Figure 6J It shows Figure 6H Another view (concave side view).

[0136] exist Figure 6G , 6H In 6I and 6J, adjusting nuts 344a, 344b, 344c, and 344d; multi-axis connectors 360a and 360b; and single-axis connectors 320a and 320b all comprise metal coated with Teflon®. All single-axis connectors, multi-axis connectors, and adjusting nuts discussed herein may comprise metal, Teflon®, a combination of both (e.g., metal with a Teflon® coating), polymers, or composite materials.

[0137] Figures 7A-7G Showing Figure 2I Various applications of the stabilizer component 200 shown. Figure 7A This is a schematic diagram of coronal plane control correction using stabilizer assembly 200. Figure 7B This is a schematic diagram of sagittal plane control correction using stabilizer assembly 200. Figure 7C This is a schematic diagram of longitudinal correction using stabilizer assembly 200. Figure 7D Stabilizer assembly 200 is shown, wherein hinge 205 is located at the apex of the spinal deformation, where VCR has been performed. Figure 7E and 7F This demonstrates how to connect the hinge of stabilizer assembly 200 with... Figure 5A and 5B The operating components 500 shown are used together for spinal correction. Figure 7G This demonstrates how to use the hinge 205 of the stabilizer assembly 200 for stabilization. Figure 7E and 7F The spinal correction shown.

[0138] Embodiments of the present invention can be used in conjunction with existing instruments, tools and other equipment for treating spinal diseases.

[0139] The components of this invention, including stabilizer assemblies and multi-axis connectors, can be made of durable and implantable non-biological materials, such as titanium, stainless steel, spring steel, aluminum, niobium, carbon fiber, ceramics, polymers, composite materials, or any relatively rigid alternative material (e.g., titanium-aluminum-niobium alloys). Typically, the selected materials should be biocompatible, i.e., compatible with surrounding bone and tissue.

[0140] Figure 8 A flowchart of an embodiment of the method of the present invention is shown. A method 800 for stabilizing the spine includes step 805, positioning a patient requiring spinal stabilization, wherein multiple spinal rods have been fixed to their spine. Step 810 includes connecting a stabilizer assembly of the spinal orthopedic device to at least one of the plurality of spinal rods, wherein the stabilizer assembly includes a hinge comprising: a first rod support plate; a second rod support plate rotatably connected to the first rod support plate to allow the stabilizer assembly to have coronal or sagittal degrees of freedom, or both; a locking mechanism for locking the first and second rod support plates at a desired angle; a first stabilizer rod connected to the first rod support plate; a second stabilizer rod connected to the second rod support plate, wherein the first stabilizer rod, the second stabilizer rod, or both are threaded, and an adjusting nut is mounted on the first stabilizer rod, the second stabilizer rod, or both to achieve a longitudinal degree of freedom; and a plurality of multi-axis connectors, wherein each multi-axis connector is movably connected to the first or second stabilizer rod and movably connected to the first or second spinal rod fixed to the spine. Step 815 includes fixing the spine to the desired spinal morphology. Step 820: Connect the stabilizer assembly to the first or second spinal rod to stabilize the spine and prevent compression, traction or displacement of the spinal cord during spinal correction.

[0141] Figure 9A A joystick 905, an operating clamp 915, and a stabilizer assembly 200 are shown. While the joystick 905 and 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 stabilizer assembly 100 (not shown). As shown, the joystick 905 is connected to the hinge 205 of the stabilizer assembly 200, and the operating clamp 915 is connected to the stabilizing bar 230 of the stabilizer assembly 200 and to the spine bar 140. The operating clamp 915 can also be connected to the stabilizing bar 225 of the stabilizer assembly 200 and to the spine bar 135.

[0142] Figure 9BAn operating lever 905 is shown to be connected to the hinge 205 of the stabilizer assembly 200. The operating lever 905 includes a handle 907 fixed to the proximal end of the operating lever 905, a lever body 909, and a connection mechanism 911 fixed to the distal end of the operating lever 905. In an exemplary embodiment, the connection mechanism 911 includes a threaded groove (not shown) configured to be threadedly connected to a threaded hinge bolt 913. Once connected to the hinge 205, the operating lever 905 can be used to manipulate the stabilizer assembly 200. The lever body 909 can be straight or curved, and its cross-section can be circular, elliptical, triangular, square, pentagonal, hexagonal, or other polygonal.

[0143] Figure 9C A side view of an operating clamp 915 connected to the stabilizer bar 230 and the spindle bar 140 is shown. The operating clamp 915 includes two clamp arms 917a, b rotatably connected to each other. At the proximal end of the operating clamp 915, the two clamp arms 917a, b engage with each other via a disengaged ratchet mechanism 919. At the distal end of the operating clamp 915, each of the clamp arms 917a, b includes a clamping surface, namely clamping surfaces 921a, b, on which grooves are provided for engagement with the stabilizer bar 230 and the spindle bar 140.

[0144] Figure 9D The distal end of the operating clamp 915 connected to the stabilizer bar 230 and the spindle bar 140 is shown. At the distal end of the operating clamp 915, each of the clamp arms 917a and b includes a clamping surface, clamping surfaces 921a and b (where 921b is not shown), which are provided with grooves for engaging with the stabilizer bar 230 and the spindle bar 140.

[0145] Figure 9E The rod support plates 210 and 215 of the stabilizer assembly 200 are shown respectively. Rod support plate 215 includes a bolt hole 925 configured to receive a bolt 927 carrying a nut 929, such that the bolt 927 is received by the rod support plate 210. The bolt 927 connects the stabilizer rod 230 to the rod support plate 215. Similarly, rod support plate 210 includes a bolt hole 931 for receiving a bolt (not shown) carrying a nut (not shown), such that the bolt is received by the rod support plate 210, thereby connecting the stabilizer rod 225 (not shown) to the rod support plate 210.

[0146] Figure 9F The rod-bearing plates 210 and 215 of the stabilizer assembly 200, connected at hinge 205, are shown. Figure 9F In the middle, the rod bearing plates 210 and 215 are coupled by hinge bolt 913 and bolts 927 and 933, wherein bolts 927 and 933 respectively carry nuts 929 and 935 and are partially inserted into bolt holes 925 and 931 (not shown).

[0147] Those skilled in the medical field of human spinal diseases will understand that devices for treating spinal diseases, including stabilizer assembly 100, stabilizer assembly 200, and method 700, provide effective methods and systems that can reduce the risk of spinal cord compression, traction, or displacement during the stabilization, adjustment, and fixation of deformed vertebrae that have undergone vertebroplasty or spinal correction.

[0148] Severe angular kyphosis is a spinal deformity characterized by excessive forward curvature of the thoracic or thoracolumbar vertebrae, resulting in a sharp angulation exceeding 70–100° [1–2]. This condition can significantly impact an individual's quality of life, leading to various physiological and functional impairments, such as cardiopulmonary dysfunction and neurological deficits [3–4]. Treating complex and severe angular kyphosis presents a significant challenge for surgeons and medical teams and often requires a vertebral column resection (VCR), in which one or more intact vertebrae are removed to correct the sagittal imbalance [5–10].

[0149] In current VCR strategies used to treat severe angular kyphosis [5-16], multiple pedicle screws are used proximally and distally at the apical vertebral resection to securely fix the spine before any bone resection is performed. During bone resection, temporary rods are secured to prevent sudden translation of the spine, which could lead to spinal cord injury. Reduction is achieved by compressing and / or replacing temporary preformed rods one by one, or by bending rods in situ to shorten and move the spine. An interbody fusion cage is placed at the VCR level to provide anterior column support, serving as a pivot for kyphosis correction. However, these techniques have several drawbacks: 1) There is a risk of intraoperative accidents due to instability caused by compressing and replacing temporary rods, which could lead to segmental subluxation of the spine and impingement of the dura mater, resulting in spinal cord injury. 2) An inappropriate anterior support fusion cage may lead to excessive shortening of the ventral spinal cord, potentially causing spinal cord injury. 3) Bending rods in situ to correct angular kyphosis may cause spinal cord traction, resulting in further injury. 4) The temporary bar is rigid and lacks an adjustable mechanism in the apical vertebral resection area, which may limit the corrective effect. 5) Although fixation is not effective in severe spinal deformities, closure of the resection space is usually achieved with a single pedicle screw. 6) Repeated attempts to remove and insert the temporary bar during surgery require additional time and may lead to increased blood loss.

[0150] Considering the aforementioned issues, we aim to overcome the limitations of current VCR strategies in the treatment of severe angular kyphosis by developing a novel correction system called the uniplanar clamp-hinge (Uni-CH). Our primary objectives are to design a device with the following advantages: 1) continuous stabilization of the spinal segment during reduction to reduce the risk of intraoperative complications; 2) adjustable hinge control at the top of the resection area to protect the spinal cord from excessive shortening and displacement; 3) adjustable mechanism control at the resected gap to enhance deformity correction; 4) reduction of reliance on individual pedicle screws by shortening the resected gap and utilizing constructive rods above and below the vertebral segments; and 5) improved VCR device procedures to optimize surgical time.

[0151] This study has a dual purpose. First, we aim to introduce Uni-CH and demonstrate its application in a saw bone model simulating severe angular kyphosis. Second, we attempt to use Uni-CH to correct severe angular kyphosis deformity in the saw bone and to determine the optimal hinge position for VCR reduction in angular kyphosis.

[0152] Figure 10 A uniplanar clamp hinge (Uni-CH) 1000 is shown, which includes a dual-axis hinge (DA-H) 1005, two uniplanar clamps (UN-C) 1010, a stabilizing bar 1020, two temporary spindle bars 1025, and two reset bar holders 1030.

[0153] Figure 11A The DA-H 1005 is shown, comprising two hinge rods 1006, a dual-axis hinge support plate 1007, and a locking screw 1008. The two hinge rods 1006 are rotatably connected to the two hinge rod support plates 1007, respectively. The first hinge rod support plate 1007 is rotatably connected to the second hinge rod support plate 1007 to allow movement within a single plane. The locking screw 1008 locks the first and second hinge rod support plates 1007 at the desired angle to control sagittal plane correction. The DA-H 1005 is designed with two axes of rotation to minimize hinge displacement during reset operations. The DA-H 1005 features a low-profile design, enabling free movement at any desired hinge position. Figure 11B The range of motion of the DA-H 1005 in one direction is shown. Figure 11CThe range of motion of the DA-H 1005 in opposite directions is shown. H1 is the hinge axis at the distal portion, and H2 is the axis at the proximal portion. The line between H1 and H2 is the hinge position line (HPL), which serves as a reference position for the DA-H 1005 to be positioned appropriately relative to the deformity. The length of the HPL can vary depending on the deformity, allowing for flexible selection of the appropriate DA-H 1005.

[0154] Figure 12A A front view of the UN-C 1010 is shown. The UN-C 1010 is designed with two spring-loaded snap-fit ​​clamps 1011 (not shown; see [link]). Figure 12B It also accommodates three rods, namely rod 1006, rod 1020, and rod 1025. Two spring-loaded latches 1011 respectively accommodate the hinge rod 1006 and the temporary spine rod 1020. In addition, an integrated locking tongue 1012 on the temporary spine rod portion of the clamp 1010 accommodates the stabilizing rod 1020. Figure 12B A side view of UN-C 1010 is shown. UN-C 1010 has two separate rod locking nuts 1013 and 1014 and a stabilizing rod locking bolt 1015. The spinal rod locking nut 1014 locks the temporary spinal rod 1025 but not the hinge side of clamp 1010. The hinge rod locking nut 1013 locks the hinge rod 1006 but not the temporary spinal rod side of clamp 1011. Therefore, the hinge rod locking nut 1013 can be loosened to reposition DA-H1000 without affecting the spinal rod 1025 side of clamp 1011. The stabilizing rod 1020 is used to stabilize the cut-off gap when its locking bolt 1015 is tightened. By loosening the locking bolt 1015, the proximal and distal spinal segments can be angled relative to the hinge axis. Axial displacement of these segments in all other planes, as well as shearing and bending, are suppressed. When the stabilizer bar 1020 is securely engaged, the hinge bar locking nut 1013 can be loosened to reposition the DA-H 1000 without compromising stability.

[0155] The Sawbones spinal model (model 1323-23; Sawbones, Vashon, Washington) including the T1 to sacral segments was used to simulate severe angular kyphosis of the thoracolumbar spine. Figure 13 ). Figure 13Bilateral pedicle screws (5.5 mm diameter multiaxial pedicle screws, CD Horizon Legacy, Medtronic) inserted at T8-T10 and T12-L2 are shown, while the apical vertebra T11 remains uninstrumented. The apical vertebra T11 is adjusted to form a wedge-shaped vertebra. Subsequently, bilateral 5.5 mm diameter kyphotic rods pre-shaped with a 104° curvature are placed to induce angular kyphosis of the thoracolumbar spine with its apex at T11. The angle of this angular kyphosis in the T9-L1 segment is measured to be 83° using the Cobb method.

[0156] Figure 14 This is a schematic diagram of the resection, where T11 at the apex is removed, and portions of T10 and T12 are excised. After the vertebral resection procedure is completed, the spine is divided into cephalic and caudal sections at the site of resection. Two temporary spinal rods are fixed to the right side, one to the cephalic section (T8-T10) and the other to the caudal section (T12-L2). Figure 15 The diagram illustrates the use of the temporary spinal bar clamp on the right side to secure a UN-C to each of the cephalic and caudal temporary spinal bars, respectively. Figure 16 A stabilizer bar spanning the cut-off gap is shown, secured using locking bolts.

[0157] After the vertebral resection procedure was completed, the right kyphotic rod was removed, and two temporary spinal rods were fixed to the cephalic (T8-T10) and caudal (T12-L2) segments. Figure 14 Then, temporary spinal rod clamps are used to secure the UN-Cs to each temporary spinal rod. Each UN-C is positioned directly above and below the resected area, and its orientation is perpendicular to the spinal rod in the sagittal plane. Figure 15 To achieve stability, locking bolts are used to secure the stabilizing bar across the cutaway. The stabilizing bar is oriented parallel to the spinal cord in the sagittal plane. Figure 16 ).

[0158] Use the UN-C hinge clamp to insert DA-H ( Figure 17 In this study, the HPL length for DA-H was set at 30 mm. This choice was determined based on measurements of the posterior vertebral body wall gap (PVBWG). It is important that the HPL length be comparable to the PVBWG to avoid excessive shortening or elongation of the spinal cord ventrally. The position of the HPL (used as a reference hinge position) can be adjusted within the resection area to accommodate various malformations by manipulating hinge clamps. Figure 18A and Figure 18B ).

[0159] Figure 17 A schematic diagram illustrating the placement and securing of DA-H using UN-C's hinge clamps. Figure 18A The hinge position line (HPL) located at the posterior vertebral body wall is shown. Figure 18B The HPL (Hyperplasia Proportional) is shown at the posterior third of the vertebral body. The position of the HPL can be adjusted by rotating the hinge clamp (as indicated by the arrow).

[0160] To evaluate the repositioning of the cut-off gap at different hinge positions, six different hinge positions were created for evaluation. Figure 19 The following is a schematic diagram of the six HPL locations: 1-posterior vertebral body elements; 2-center of the spinal canal; 3-posterior wall of the vertebral body; 4-posterior third of the vertebral body; 5-middle third of the vertebral body; and 6-anterior third of the vertebral body.

[0161] After fixing and locking the DA-H, the remaining kyphotic rods were subsequently removed, leaving a spinal segment supported only by the Uni-HC. Baseline measurements of the resected gap were obtained before initiating the reduction procedure. Measurements of the resected gap were taken at three specific points. Figure 20 The following were recorded: 1) posterior vertebral element gap (PVEG); 2) posterior vertebral body wall gap (PVBWG); and 3) anterior vertebral body wall gap (AVBWG). Additionally, the length of the instrumented segments (ISL) and apical vertebral translation (AVT) from T8 to L2 were recorded.

[0162] Figure 20This diagram illustrates measurements of the resected space and spine in the midsagittal plane before reduction. In the cephalic resected portion, A1 and P1 represent the anterior and posterior margins, respectively, while P2 represents the posterior margin of the vertebral body. In the caudal resected portion, A2 and P3 represent the anterior and posterior margins, respectively, and P4 indicates the posterior margin of the vertebral body. The distance between A1 and A2 corresponds to the anterior vertebral body wall space (AVBWG). The distance between P1 and P3 is the posterior vertebral body wall space (PVEG), and the distance between P2 and P4 represents the posterior vertebral body wall space (PVBWG). C1 represents the midpoint of the superior margin of T8, and C2 represents the midpoint of the inferior margin of L2. Lines 1 and 2 are perpendicular lines passing through C1 and C2, respectively. The distance between lines 1 and 2 is the length of the internal fixation segment (ISL) from T8 to L2. C3 is the midpoint of the anterior vertebral body wall, and the distance between C3 and the base corresponds to the apical offset (AVT).

[0163] The correction of angular kyphosis begins with loosening the locking screws. One operator holds the reduction rod holder on one side, while another operator controls the DA-H on the opposite side. After loosening the hinge locking screws, the resected gap is closed by gradually applying compressive force to the rod holder. Figure 21 The purpose of the compression bar clamp is to reduce the posterior vertebral space, lengthen the anterior portion of the vertebral body, and shift the spine from the dorsal to the ventral side. Throughout the reduction procedure, any possible axial displacement of the spinal segment in other planes, as well as shearing and bending, are carefully assessed. Once correction is achieved ( Figure 22 Then, firmly tighten the stabilizing locking bolt and hinge locking screw. Next, measure the removed gap and compare it to the gap before repositioning to assess the degree of shortening or lengthening of the PVEG, PVBWG, and AVBWG. Figure 23 In addition, ISL and AVT were also remeasured.

[0164] For each of the six hinge positions, correction procedures were performed for severe angular kyphosis of the spine, and the corresponding data were recorded. The percentage change (%) of the resected space was determined using the following formula: (Post-reduction length - Pre-reduction length) / Pre-reduction length × 100%. Positive values ​​indicate elongation, while negative (-) values ​​indicate shortening of the resected space. The Cobb angle correction rate was calculated as (Post-reduction angle - Pre-reduction angle) / Pre-reduction angle × 100%. The ISL elongation rate was calculated as (Post-reduction length - Pre-reduction length) / Pre-reduction length × 100%. The AVT from the dorsal to the ventral side was calculated as the pre-reduction AVT minus the post-reduction AVT.

[0165] Figure 21 The spine with Uni-CH installed before reduction is shown. The HPL is located on the posterior wall of the vertebral body. Figure 22The image shows the spine immediately after repositioning and mounting the Uni-CH. Figure 23 This is a schematic diagram of measuring the resection gap and spine immediately after reduction in the midsagittal plane.

[0166] After correction, tighten the locking bolts and hinge locking screws firmly. Measure the final rod and position it on the left. Figure 24 A top view of the structure is shown, with the final rod positioned on the left. Set screws are used to secure the final rod in place. The set screws (indicated by arrows) are then intentionally loosened to act as guides for further closing the cut-off gap in the head-to-tail direction.

[0167] A fusion clamp was used to support the anterior column of the resection area. The process of closing the resection gap in the ante-to-extrinsic direction involves loosening the locking bolts and hinge locking screws, followed by compressing the rod holder (…). Figure 25 This technique ensures that the reduction force is distributed across multiple vertebral segments because the resection gap closes from the upper structural bar to the lower structural bar. Figure 25 This is a schematic diagram of using a fusion device to support the anterior column of the resection area. Closure of the resection gap in the anteroposterior direction is completed during this stage.

[0168] After successful closure of the excision gap, the final bar on the left side was securely fastened using set screws. Then, the Uni-CH and temporary spinal bar were removed, and the final bar on the right side was securely fixed. Figure 26 ). Figure 26 This is a diagram illustrating the final rod being fixed on the right side after the Uni-CH and temporary spinal rod have been removed.

[0169] Figure 27A This is a schematic diagram showing the HPL located at the posterior edge of the vertebral body in the pre-reduction stage. Figure 27B This is a schematic diagram of the spine immediately after repositioning. The posterior vertebral wall space (PVBWG) or the base of the spinal cord has lengthened by 105%.

[0170] Figure 28A This is a schematic diagram showing the HPL located at the anterior 1 / 3 of the vertebral body before repositioning. Figure 28B This is a schematic diagram of the spine immediately after repositioning. The posterior vertebral wall space (PVBWG), or the floor of the spinal cord, is shortened by 74%.

[0171] Before correction, the mean angle of angular kyphosis in the thoracolumbar spine was 82.7±0.5°, with the apex located at T11. The mean values ​​of PVEG, PVBWG, and AVBWG were 43.4±0.5 mm, 32.4±0.5 mm, and 14.2±0.4 mm, respectively. The mean values ​​of ISL and AVT were 138.3±0.7 mm and 117.8±3.0 mm, respectively.

[0172] After correction, the angle of kyphosis was corrected to 0°, meaning a 100% correction rate. The average change in AVT from the dorsal to the ventral side was measured to be 107.5 ± 3.7 mm. ISL showed an increase from the pre-reduction average of 138.3 ± 0.7 mm to the post-reduction average of 192.6 ± 20.9 mm, representing an average increase of 39.2 ± 15.2%.

[0173] No axial displacement, shearing, or bending of the spinal segment was observed in other planes during the reduction maneuver.

[0174] Figure 29 Table 1 shows the percentage change in lengthening (positive) or shortening (negative) of the excision gap at different hinge positions after reduction using a 30mm hinge. When the HPL is located at the spinal canal and posterior vertebral body margin, the PVBWG increases, ranging from 41.6% to 104.7%. However, when the HPL is located at the posterior vertebral body wall, the PVBWG shortens slightly by 3%. Furthermore, when the HPL is located at the vertebral body, the PVBWG shortens by a range of 26.7% to 74%.

[0175] Figure 30 Table 2 shows the percentage change in length (positive) or length (negative) at the cut-off gap at different hinge positions after resetting using a 15mm hinge.

[0176] Figure 31 Table 3 shows the percentage change in length (positive) or length (negative) at the cut-off gap at different hinge positions after resetting using a 30mm hinge.

[0177] In cases of severe angular kyphosis, the apical vertebra is positioned posteriorly, causing the spinal cord to be stretched posteriorly and tightly covered by the posterior wall of the vertebral body or the base of the spinal canal [6-8, 10, 14]. The VCR procedure for angular kyphosis aims to shorten the posterior portion of the resection area and lengthen the anterior portion, thereby effectively shifting the spine from the dorsal to the ventral side

[17] . Abnormalities observed in the spine at the apex have provided important insights for the VCR procedure.

[0178] First, when beginning the resection of the apical vertebra, it is crucial to perform the resection of the posterior wall of the vertebral body before removing the anterior portion. This approach allows the apical spinal cord to drift slightly more ventrally and reduces tension before proceeding with the removal of the anterior portion. However, in actual VCR procedures, the posterior wall of the vertebral body is usually the last part to be removed in order to minimize epidural hemorrhage [7, 8, 10, 14]. Therefore, the apex must be continuously and firmly stabilized during resection, as the spinal segment becomes very unstable, increasing the risk of slight stretching of the spinal rod above the apex

[18] .

[0179] Secondly, after resection, the reduction process involves narrowing the gap created by the resection and shifting the spine ventrally. It is crucial to ensure that the spinal cord is always shortened, not lengthened, with posterior compression being the primary corrective technique. Lengthening should only be performed after sufficient shortening has been achieved, to allow adequate relaxation of the ventral dura mater / spinal cord. However, in some cases where the compression hinge is inadequate, posterior compression forces can inadvertently cause traction or stretching of the spinal cord. Loss of motor evoked potential monitoring data has been reported most frequently during spinal compression correction [7, 8, 10, 14].

[0180] Third, for patients with severe angular kyphosis, it is crucial to ensure proper placement of the interbody fusion cage. The anterior fusion cage acts as a hinge for kyphosis correction and prevents excessive shortening of the spinal cord and ventral flexion. However, providing adequate anterior support is challenging because the anterior intervertebral space transitions from a short to a long state during kyphosis reduction. Therefore, the initial selection of anterior fusion cages is often short, which can lead to excessive shortening of the spinal cord. Excessive shortening of the ventral spinal cord has been reported to result in loss of motor evoked potential data when using shorter anterior column-supported fusion cages [7, 8, 10, 14].

[0181] Fourth, closure should be performed from the upper structural rod to the lower structural rod, distributing the corrective force across multiple locations to achieve reduction of the resected gap. This method prevents any ventral drift of the spinal segment, especially caudal to the VCR. Since the lower spine and hip are typically in extension on the operating table, the distal spine often tends to shift ventrally after resection and during closure of the resected gap, thus applying ventral pressure to the more proximal spinal segment with neural elements [7, 8, 10, 14]. However, current reduction procedures are performed using individual pedicle screws, even in patients with poor bone mass. Shortening the resected gap with individual pedicle screws can lead to correction failure and spinal subluxation.

[0182] Considering the pathological anatomy of severe angular kyphosis and the limitations of current surgical techniques, we developed Uni-CH to improve the safety and effectiveness of VCR for severe angular kyphosis. Uni-CH addresses the challenges associated with exchanging temporary bars by continuously and firmly stabilizing the spine above and below the resection space. This feature is crucial in the prevention and treatment of spinal subluxations, which pose significant risks during these procedures.

[0183] The main advantage of Uni-CH is its adjustable and controllable hinge mechanism, which prevents excessive shortening or lengthening of the spinal cord during reduction manipulation. Our data show that when the hinge pivot is positioned at the posterior wall of the vertebral body, PVBWG remains essentially unchanged, with only a 3% shortening during reduction manipulation. This results in a 47.1% shortening of the posterior vertebral body and a 248.6% lengthening of the anterior vertebral body, which is beneficial for ventral displacement of the spine.

[0184] It is important to note that when the hinge is located in the spinal canal region or at the posterior margin of the vertebral body (which lies behind the posterior wall of the vertebral body), our measurements indicate that PVBWG elongation was 41.6% and 104.7%, respectively, with the more posterior location resulting in greater elongation. This could lead to spinal cord traction. Therefore, these results suggest that the hinge should not be located at the posterior margin of the vertebral body during reduction of angular kyphosis, as this could lead to spinal cord elongation and pose a risk of spinal cord damage. Figure 27A and Figure 27B ).

[0185] On the other hand, when the hinge is located in the vertebral body region (anterior to the posterior wall of the vertebral body), PVBWG showed shortening ranging from 26.7% to 74%, with more anterior positions resulting in greater shortening. This may explain why, in clinical practice, the spinal cord is excessively shortened during reduction of angular kyphosis when an anterior support fusion cage is used as the hinge pivot (especially with shorter fusion cages) [7, 8, 10, 14]. Our data suggest that when using a fusion cage as the hinge pivot, it should be positioned posteriorly rather than anteriorly on the resected vertebral body to prevent excessive shortening of the ventral spinal cord (Fig. 28).

[0186] Uni-CH plays a crucial role in achieving a construct-to-construct closure mechanism during shortened reduction of the resected area. It effectively connects to temporary spinal rods in multiple locations, thus functioning as a unified construct above and below the resected space, thereby avoiding reliance on individual pedicle screws. This provides a controllable and adjustable mechanism for applying corrective compressive forces between the constructs.

[0187] Several limitations need to be considered in this study. First, the saw-shaped bone simulation model used cannot fully replicate the complexity of severe angular kyphosis in humans, making it impossible to assess the actual neurological safety of the VCR procedure. Nevertheless, it is important to note that our primary objective was to test the basic principles and ideas. Second, the data collection in this study was based on a 100% correction rate for the deformity. We acknowledge that achieving a 100% correction rate in real-world cases of severe angular kyphosis can be challenging. Third, the hinges used in this study had a fixed length of 30 mm for both axes. While the results effectively validated our objectives, it would be beneficial to explore hinge selection strategies using hinges of different sizes. Additional data have been included in the appendix, particularly… Figure 30 Table 2 and Figure 31 Table 3 shows the results obtained using hinges with lengths of 15 mm and 45 mm, respectively.

[0188] In summary, Uni-CH has demonstrated its ability to sustainably stabilize spinal segments and provide an adjustable and controllable hinge for VCR correction in severe angular kyphosis using a saw bone model. The appropriate hinge should be selected based on the length of the PVBWG (vertebral body bone flexion zone). Positioning the hinge pivot at the posterior wall of the vertebral body maintains the PVBWG, thereby preventing excessive shortening or elongation of the spinal cord during VCR reduction in severe angular kyphosis.

[0189] Figure 32 This is a schematic diagram of another embodiment of a uniplanar clamp hinge (Uni-CH) 3200. This embodiment includes a gear-type dual-axis hinge 3205, two uniplanar clamps (UN-C) 3210, a stabilizing return bar 3220 with opposite pitch threaded ends, and two temporary spine bars 3225.

[0190] Figure 33 A stable reset threaded rod 3220 is shown, which includes a rigid hexagonal central connector 3221, a reset rod 3220 with threaded ends having opposing pitches, and two threaded travel members 3223.

[0191] Figure 34A This is a top view of the gear-type dual-axis hinge 3205. The gear-type dual-axis hinge 3205 includes two hinge rods 3206, four dual-axis rotating gears (not shown), and a locking screw (not shown; see [link]). Figure 34BThe hinge rod 3206 is rotatably connected to the gear, enabling single-plane motion. A locking screw secures the gear at the desired angle, thus controlling sagittal plane correction. The gear-type biaxial hinge 3205 is specifically designed to minimize hinge translation during reset operations by providing two axes of rotation. Its compact design allows the hinge to move freely in any hinge position. Figure 34B A front view of a gear-type biaxial hinge including a locking screw 3207 is shown. Figure 34C The range of motion of the gear-type dual-axis hinge 3205 in one direction is shown. Figure 34D The range of motion of the gear-type dual-axis hinge 3205 in opposite directions is shown. H1 represents the hinge axis of the distal portion, while H2 represents the axis of the proximal portion. The line connecting H1 and H2 is called the hinge position line (HPL), which serves as a reference position when the hinge is positioned relative to the deformity. The length of the HPL can be adjusted according to a specific deformity, thus allowing for greater flexibility in selecting the appropriate hinge position.

[0192] Figure 35A This is a front view of the UN-C 3210. The UN-C 3210 is designed with two spring-loaded snap-fit ​​clamps 3211 (not shown; see [link]). Figure 35B This fixture is used to accommodate three rods: rod 3206, rod 3220, and rod 3225. A first snap-fit ​​clamp 3211 accommodates the hinge rod 3206, while a second snap-fit ​​clamp 3211 accommodates the temporary spine rod 3225. Additionally, the clamp on the temporary spine rod portion of clamp 3210 features an integrated locking tongue 3212, which connects to the stable return threaded rod 3220. Figure 35BA side view of UN-C 3210 is shown. UN-C 3210 includes two separate rod locking nuts 3213, 3214 and a stabilizing rod locking bolt 3215. The spinal rod locking nut 3214 secures the temporary spinal rod 3225 but does not lock the clamp onto the hinge rod 3206. On the other hand, the hinge rod locking nut 3213 locks the hinge rod 3206 without affecting the temporary spinal rod 3225 side of the clamp. Therefore, the hinge rod locking nut 3213 can be loosened to reposition the geared biaxial hinge 3200 without affecting the stability of the spinal rod 3225 side of the clamp. A stabilizing reset threaded rod 3220 is used to stabilize the cut-off gap when its locking bolt 3215 is tightened. By loosening the locking bolt 3215 and rotating the rigid hexagonal center connector 3221 (not shown), the proximal and distal spinal segments can be angled about the hinge axis. UN-C 3210 restricts axial displacement of each segment and prevents shear and bending in all other planes. When the stabilizer bar 3220 is securely engaged, loosening the hinge bar locking nut 3213 to reposition the hinge does not affect stability.

[0193] Figure 36A This is a schematic diagram of a gear-type biaxial hinge positioned on the posterior wall of the vertebral body during the pre-reduction phase. By rotating the rigid hexagonal central connector, the two threaded traveling members move towards the center to correct angular kyphosis of the spine. Figure 36B This is a schematic diagram of angular kyphosis of the spine with a correction rate of 50%. Figure 36C A schematic diagram illustrating the process of achieving 100% correction of angular kyphosis.

[0194] Figure 37A This diagram illustrates the use of a vertebral body fusion brace as a hinge to correct angular kyphosis of the spine. By rotating the rigid hexagonal central connector, the two threaded traveling members move towards the center to achieve the correction of angular kyphosis. Figure 37B This is a diagram illustrating the complete correction of 100% of angular kyphosis of the spine.

[0195] Figure 38 A reduction device (RD) correction system 3800 is shown, which includes two single-plane clamps 3805a and 3805b (see Figure 39 and 40 ), a reset rod 3810 with two opposing pitch thread ends (see Figure 41 ), stabilizer bar 3815, two temporary spinal rods 3820a and 3820b, adjustable interbody fusion cage 3825, and constant force compression device 3830 (see Figure 42The RD correction system is used to correct angular kyphosis of the thoracolumbar vertebrae in a saw bone model. A single-plane clamp 3805a or 3805b is applied to each temporary spinal bar 3820a or 3820b, one cephalad and the other caudal. Stabilizing bars 3815 for stabilizing the spinal segment and repositioning bars 3810 with threaded ends of opposing pitch (capable of compression repositioning) are secured by locking bolts across the resection gap and threaded repositioning bolts 3807a and 3807b (not shown, see [link]). Figure 40 and 41 The adjustable interbody fusion cage 3825 is placed within the resection space, providing solid anterior column support for the resection area and acting as a reduction hinge. A constant force cable 3835 is secured to provide an adjustable constant tension within the range of 5-10 pounds using a constant force compression device 3830. This constant force cable 3835 plays a crucial role in fixing and stabilizing the adjustable interbody fusion cage 3825, as it works in conjunction with the adjustable interbody fusion cage 3825 to fulfill its function as a reduction hinge.

[0196] This discussion uses the correction of angular kyphosis in the thoracic and lumbar spine as an example, but the invention is not limited thereto. The invention can also be used for other types of spinal surgery.

[0197] Figure 39 A front view of the single-plane clamp 3805a is shown. (The single-plane clamp 3805b, not shown, is similar to the single-plane clamp 3805a.) The single-plane clamp 3805a is designed with a spring-loaded snap 3806 for securely fixing the temporary spinal bar 3820a. It is also configured to receive the reset bar 3810, the stabilizing bar 3815, and the constant force cable 3835.

[0198] Figure 40 A side view of a single-plane clamp 3805a is shown. This clamp 3805a has three individual locking bolts, two rod locking nuts, and one cable locking positioning screw. The locking bolts are used to fix the orientation of the clamp 3805a, but they do not fix the position of the stabilizer bar 3815. On the other hand, the stabilizer bar locking nuts and the temporary spine locking nuts secure the stabilizer bar 3815 and the temporary spine bar 3820a in place. However, they do not affect the orientation of the clamp. Finally, the cable locking positioning screw is used to securely fasten the constant force cable 3835. The figure also shows a reset bar 3810, a lockable differential threaded reset bolt 3807a, and an open clamp 3808.

[0199] Figure 41The reset lever 3810 is shown, which includes a lever body 3811 with threaded ends having relative pitches, two lockable differential threaded reset bolts 3807a and 3807b, and a knob 3812 integrated into the reset lever 3811. Rotating the knob 3812 can compress or stretch the reset bolts 3807a and 3807b.

[0200] Figure 42 A side view of a custom-designed constant force compression device 3830 is shown. The device consists of several key components, including an adjustable-length mechanical base 3831, a self-locking pump handle 3832, two constant force springs 3833a and 3833b, and a cable 3835 with a cable sheath 3836. The primary function of the device is as a constant force generator. To achieve displacements up to 150 mm, the position of the constant force spinal assembly can be adjusted using the self-locking pump handle 3832. Within this range, a constant force can be applied remotely via the flexible cable assembly. At any given moment, the force is released simply by pressing the release button 3834, allowing the spring assemblies 3833a and 3833b to return to their zero-displacement position. Each of the two constant force springs 3833a and 3833b applies a force of 5 pounds, providing a total constant force of 10 pounds through independent length controls.

[0201] Severe angular kyphosis in a saw-bone spinal model. For example... Figure 43 As shown, a saw bone spinal model (model 1323-23; saw bone, Vashon, Washington) consisting of segments from T1 to the sacrum was used to simulate severe angular kyphosis of the thoracolumbar spine. Figure 43 Bilateral pedicle screws 3840 (5.5 mm diameter multiaxial pedicle screws, CD Horizon Legacy, Medtronic) were inserted at T8-T10 and T12-L2 (not shown), while no instrumentation was performed on the apical vertebra T11. The apical vertebra T11 was trimmed to form a wedge-shaped vertebral body. Subsequently, bilateral 5.5 mm diameter kyphotic rods 3841, pre-shaped with a 128° bend, were placed to induce angular kyphosis at the apex of T11 in the thoracolumbar region. The angular kyphosis angle at the T9-L1 segment was measured to be 52° using the Cobb method.

[0202] Simulation and data collection. After removing the posterior structures of the apical vertebra, the right kyphotic rod was removed, and two temporary spinal rods were fixed to the cephalic (T8-T10) and caudal (T12-L2) segments respectively (see...). Figure 44 Subsequently, a clamp was secured to each temporary spinal rod. Each clamp was positioned directly above and below the resection area, and its orientation was perpendicular to the spinal rod in the sagittal plane (see [link to original text]). Figure 45To provide stability, a stabilizing bar is secured across the resection gap using locking bolts. The stabilizing bar is oriented parallel to the spinal cord in the sagittal plane (see [link to relevant documentation]). Figure 46 ).

[0203] like Figure 44 As shown, after the posterior structure of the apical vertebra was removed, two temporary spinal rods 3820a and 3820b were fixed to the right side—one on the cephalic side and the other on the caudal side.

[0204] Figure 45 The placement of single-plane clamps 3805a and 3805b is shown, which are fixed to the corresponding head and tail temporary spinal rods on the right side, respectively.

[0205] Figure 46 The process of securing stabilizer bar 3815 by crossing the apex and using locking bolts is demonstrated.

[0206] Secure the reset rod 3810 with locking bolts (see...) Figure 47 After that, the anterior vertebral body at the top is removed. Once the entire spine has been removed, it is divided into cephalic and caudal sections, depending on the level of resection (see...). Figure 48 ).

[0207] like Figure 47 As shown, a locking bolt is used to secure the reset rod across the apex. Then, the entire apical vertebra is removed.

[0208] Figure 48 The image shows a scenario where the entire apical vertebral body is completely removed using the repositioning device 3800.

[0209] Before the repositioning procedure, the excised gap is first measured as a baseline. The excised gap is measured in three specific sections (see...). Figure 49 (1) Posterior vertebral space (PVEG): This part represents the dorsal structure of the spine. (2) Posterior vertebral wall space (PVBWG): This measurement represents the length of the spinal cord. PVBWG is equivalent to the spinal cord because it forms the base of the spinal canal and is usually adjacent to the spinal cord. In cases of severe angular kyphosis, the spinal cord lies directly above the PVBWG. In addition, PVBWG is an important radiographic reference point during surgery. (3) Anterior vertebral wall space (AVBWG): This part represents the ventral portion of the spine. In addition, the length of the internal fixation segment (ISL) from T8 to L2 and the apical offset (AVT) were recorded.

[0210] Figure 49A schematic diagram 4900 shows the resection space and spinal measurements before midsagittal reduction. In the cephalic resection portion, A1 and P1 represent the anterior and posterior margins of the vertebral body, respectively, while P2 represents the posterior margin. In the caudal resection portion, A2 and P3 represent the anterior and posterior margins of the vertebral body, respectively, while P4 represents the posterior margin. The distance between A1 and A2 corresponds to the anterior vertebral body wall space (AVBWG). The distance between P1 and P3 is the posterior vertebral body wall space (PVEG), and the distance between P2 and P4 represents the posterior vertebral body wall space (PVBWG). C1 represents the midpoint of the superior margin of T8, and C2 represents the midpoint of the inferior margin of L2. Lines 1 and 2 are perpendicular lines passing through C1 and C2, respectively. The distance between lines 1 and 2 is the length of the internal fixation segment (ISL) from T8 to L2. C3 is the midpoint of the anterior vertebral body wall, and the distance between C3 and the base corresponds to the apical offset (AVT).

[0211] Subsequently, an adjustable interbody fusion cage 3825 was custom-made to fit the resection gap and inserted into the posterior portion of the resected vertebral body. Based on measurements of the posterior gap of the resected vertebral body, the height of the interbody fusion cage 3825 was set to 28 mm. This adjustment was crucial to ensure that the height of the interbody fusion cage 3825 matched the posterior gap, thereby preventing excessive shortening of the ventral spinal cord. A constant force cable 3835 was then inserted, and a constant force of 10 pounds was applied using a constant force compression device 3830 (see [link to relevant documentation]). Figure 50 ).like Figure 50 As shown, the anterior support interbody fusion cage 3825 was positioned, and the constant force cable 3835 was securely fixed in place. To evaluate the effect of interbody fusion cages of different heights on reducing the resection gap, we used two additional interbody fusion cages of different heights, namely 19 mm and 9 mm (not shown), for evaluation.

[0212] Subsequently, the left posterior convex rod (not shown) was removed, leaving only the spinal segment supported by the repositioning device 3800 (see [link]). Figure 51 The resection gap was then remeasured and compared with the baseline measurement to assess the stability provided by the repositioning device 3800 to the spinal segment. Figure 51 The spinal segment is shown being fixed by the repositioning device 3800.

[0213] First, begin correcting the angular bulge by loosening the locking nut on the stabilizer bar 3815. Then, loosen the two reset bolts on the reset bar 3810 and the two locking bolts on the stabilizer bar 3815. Next, gradually rotate the reset bar knob 3812 counterclockwise (see...). Figure 52 This is used to gradually correct the deformity. For example... Figure 52 As shown, after complete spondylotomy, an interbody fusion cage is placed and a constant force cable is connected as a reduction hinge. The deformity is corrected methodically by rotating the reduction lever knob 3812.

[0214] After the calibration process is completed (see...) Figure 53 The locking nuts on stabilizer bar 3815 and all four bar locking bolts were securely tightened. The corrected spinal segment is now supported solely by the reduction device, and its stability was assessed to determine its ability to stabilize the corrected spine. The resection gap was measured and compared to the pre-reduction gap to assess the degree of shortening or lengthening of PVEG, PVBWG, and AVBWG. Additionally, ISL and AVT were remeasured (see...). Figure 54 ). Figure 53 The spine was shown to be immediately used with the reset device 3800 after the reset procedure. Figure 54 Schematic diagram 5400 illustrates the measurement of the resection gap and spine in the midsagittal plane, immediately after reduction.

[0215] Next, the final rod 3840 was measured and positioned on the left side. The set screw on the final rod 3840 was tightened, but left slightly loose to allow for further adjustment of the cut-off clearance (see...). Figure 55 ). Figure 55 The diagram shows a top view of the structure with the final rod 3840 positioned on the left. The set screw was intentionally loosened so that it could act as a guide when further adjusting the cut clearance in the head-to-tail direction.

[0216] To further reduce the resection gap, the procedure involved loosening the locking nut on the stabilizer bar 3815 (not shown) while keeping all locking bolts tightened, and turning the reset lever knob 3812 counterclockwise. This action shortened the spinal segment in the cephalothorax.

[0217] After the repositioning process was completed, the final bar 3840 on the left side was securely fixed. Subsequently, the repositioning device and temporary spinal bars 3820a and 3820b (not shown) were removed, and the final bar 3845 on the right side was securely fixed (see [link to original text]). Figure 56 ). Figure 56 A schematic diagram showing the final rod 3845 on the right side after the repositioning device (not shown) and temporary spinal rod (not shown) have been removed.

[0218] At each different interbody fusion cage height, angular kyphosis was repeatedly corrected, and the corresponding data were recorded. The percentage change (%) of the resected interbody space was calculated using the following formula: (corrected length - original length) / original length × 100%. A positive value indicates lengthening of the resected interbody space, and a negative value (-) indicates shortening of the resected interbody space. The Cobb angle correction rate was calculated as (corrected angle - original angle) / original angle × 100%. The ISL lengthening rate was calculated as (corrected length - original length) / original length × 100%. The AVT from the dorsal to the ventral side was calculated as the original AVT minus the corrected AVT.

[0219] VCR of thoracic and lumbar kyphosis correction using RD on three-month-old pig carcasses.

[0220] Before correction, the mean angular kyphosis of the thoracolumbar spine was 51.9±0.7°, with the apex located at T11. The mean values ​​of PVEG, PVBWG, and AVBWG were 34.7±0.7 mm, 30±0 mm, and 21.6±0.8 mm, respectively. The mean values ​​of ISL and AVT were 160.1±1.7 mm and 81.2±6.5 mm, respectively.

[0221] After correction, the angular kyphosis was corrected to 0°, achieving a 100% correction rate. The average change in AVT from the dorsal to the ventral side was 65.9 ± 7.1 mm. The ISL increased from an average of 160.1 ± 1.7 mm before reduction to an average of 174.2 ± 8.8 mm after reduction, an average increase of 8.8%.

[0222] Figure 57 The table shows the percentage change in resected intervertebral space at three different interbody fusion cage heights. When using a 28mm interbody fusion cage (corresponding to the posterior portion of the resected intervertebral space), PVBWG shortened by 17.3% during the reduction procedure. This reduction resulted in a 53.3% reduction in PVEG and a 76.9% increase in AVBWG. However, when using shorter interbody fusion cages, such as 19mm and 9mm, PVBWG decreased by 39.7% and 81.7%, respectively. Notably, the use of shorter interbody fusion cages led to a more significant shortening of PVBWG, thus having a greater impact on the spinal cord. No axial translation or shear bending of the spinal segments in other planes was observed during the reduction procedure.

[0223] The repositioning device (RD) has demonstrated its ability to provide consistent stability across spinal segments. In the scissor model, it serves as an adaptive and controllable pivot mechanism, effectively correcting severe angular kyphosis via VCR. An appropriate anterior support interbody fusion cage should be selected based on the size of the resection gap. Positioning the interbody fusion cage pivot posterior to the resected vertebral body helps protect the spinal cord and prevents excessive shortening or lengthening during VCR surgery for severe angular kyphosis correction.

[0224] Figure 58 A reduction device 3800 for pedicle subtraction osteotomy (PSO) is shown before reduction. Figure 59 A repositioning device 3800 for use in transpedicle osteotomy (PSO) after repositioning is demonstrated. Figure 60 The external hinge reduction device 3850, used to correct kyphosis of burst fractures of the vertebral body before reduction, is shown. Figure 61 An external hinge reduction device 3850 is shown for use in correcting kyphosis after vertebral burst fracture. Figure 62 The image shows a rear view of the improved external hinge repositioning device 3855 for correcting severe kyphosis before repositioning. Figure 63 The image shows a view of the modified external hinge repositioning device 3855, used to correct severe kyphosis, before repositioning, viewed from the head side. Figure 64 The rear view shows a modified external hinge repositioning device 3855 used to correct severe kyphosis after repositioning. Figure 65 The image shows a view of the modified external hinge repositioning device 3855, used to correct severe kyphotic scoliosis, after repositioning, viewed from the head side.

[0225] Figure 66 A flowchart illustrating one embodiment of the present invention is shown. Method 6600 includes step 6605, whereby a patient requiring spinal surgery is positioned. Method 6600 further includes step 6610, which involves providing a repositioning device correction system for spinal surgery, the system comprising two single-plane clamps; a repositioning rod having threaded ends with opposing pitches configured to connect to each of the two single-plane clamps; a stabilizing rod configured to connect to each of the two single-plane clamps; two temporary spinal rods, each configured to connect to a corresponding single-plane clamp; and an adjustable force compression device including a constant force cable configured to connect to each of the two single-plane clamps. Furthermore, method 6600 includes step 6615, which involves performing spinal surgery using the repositioning device correction system.

[0226] In one embodiment of this disclosure, a repositioning device correction system for spinal surgery includes, substantially or only comprises: two single-plane clamps, a repositioning rod having threaded ends with opposing pitches (the repositioning rod being configured to connect to each of the two single-plane clamps), a stabilizing rod configured to connect to each of the two single-plane clamps, two temporary spinal rods (each configured to connect to a corresponding single-plane clamp), and an adjustable force compression device including a constant force cable configured to connect to each of the two single-plane clamps. In one aspect, each of the two single-plane clamps includes a stabilizing rod locking bolt and a stabilizing rod locking nut for connecting the stabilizing rod to the single-plane clamp. In another aspect, each of the two single-plane clamps includes an open clamp, a spring-loaded latch, and a temporary spinal locking nut for connecting a temporary spinal rod to the single-plane clamp. In yet another aspect, the adjustable force compression device further includes an adjustable-length mechanical base connected to the constant force cable. In yet another aspect, the adjustable force compression device further includes a self-locking pump handle connected to the constant force cable. In another aspect, the adjustable force compression device also includes two constant force springs connected to constant force cables.

[0227] In another embodiment of this disclosure, a kit for a repositioning device correction system for spinal surgery includes, substantially consists of, or consists only of: two single-plane clamps; a repositioning rod having threaded ends with opposing pitches configured to connect to each of the two single-plane clamps; a stabilizing rod configured to attach to each single-plane clamp; two temporary spinal rods, each configured to attach to a corresponding single-plane clamp; an adjustable force compression device including a constant force cable configured to attach to each single-plane clamp; and one or more tools for assembling or operating the repositioning device correction system. In one aspect, each single-plane clamp includes a lockable differential threaded repositioning bolt for attaching the repositioning rod to the single-plane clamp. In another aspect, each single-plane clamp includes a stabilizing rod locking bolt and a stabilizing rod locking nut for attaching the stabilizing rod to the single-plane clamp. In yet another aspect, each single-plane clamp includes an open clamp, a spring-loaded snap-fit, and a temporary spinal rod locking nut for attaching a temporary spinal rod to the single-plane clamp. In another aspect, the adjustable force compression device also includes an adjustable-length mechanical base connected to a constant force cable. In another aspect, the adjustable force compression device also includes a self-locking pump handle connected to a constant force cable. In yet another aspect, the adjustable force compression device also includes two constant force springs connected to the constant force cable.

[0228] In another embodiment of this disclosure, a method of using a repositioning device correction system for spinal surgery includes, substantially or onlyly, the following steps: positioning a patient requiring spinal surgery; providing a repositioning device correction system comprising two single-plane clamps; a repositioning rod having threaded ends with opposing pitches configured to connect to each of the two single-plane clamps; a stabilizing rod configured to connect to each of the two single-plane clamps; two temporary spinal rods, each configured to connect to a corresponding single-plane clamp; and an adjustable force compression device including a constant force cable configured to connect to each of the two single-plane clamps; and performing spinal surgery using the repositioning device correction system. In one aspect, each single-plane clamp includes a lockable differential threaded repositioning bolt for attaching the repositioning rod to the single-plane clamp. In another aspect, each single-plane clamp includes a stabilizing rod locking bolt and a stabilizing rod locking nut for attaching the stabilizing rod to the single-plane clamp. In yet another aspect, each single-plane clamp includes an open clamp, a spring-loaded latch, and a temporary spinal rod locking nut for attaching a temporary spinal rod to the single-plane clamp. In another aspect, the adjustable force compression device also includes an adjustable-length mechanical base connected to a constant force cable. In another aspect, the adjustable force compression device also includes a self-locking pump handle connected to a constant force cable. In yet another aspect, the adjustable force compression device also includes two constant force springs connected to the constant force cable.

[0229] It should be understood that the specific embodiments described herein are shown by way of illustration and not limitation. The main features of the invention may be employed in various embodiments without departing from the scope of the invention. Those skilled in the art will recognize or be able to determine many equivalent ways of the specific processes described herein using no more than conventional experimentation. Such equivalent ways are considered to be within the scope of the invention and are covered by the claims.

[0230] All publications and patent applications mentioned in this specification indicate the level of expertise of a person 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 were specifically and individually indicated to be incorporated by reference.

[0231] When used in conjunction with the term "comprising" in the claims and / or description, the article "a" or "an" may mean "one / a," but may also refer to "one / a or more / a," "at least one / a," and "one / a or more than one / a." Unless explicitly stated that only alternatives are referred to or that alternatives are mutually exclusive, the use of the term "or" in the claims means "and / or," but this disclosure also supports referring only to alternatives and the limitation of "and / or." In this application, the term "about" is used to indicate that a value includes a device, an inherent error variation in the method for determining a value, or a variation existing between the subjects under investigation.

[0232] The terms “comprising” (and any form thereof, such as “comprise” and “comprises”), “having” (and any form thereof, such as “have” and “has”), “including” (and any form thereof, such as “includes” or “include”), or “containing” (and any form of containing, such as “contains” and “contain”) as used in this specification and claims are inclusive or open-ended and do not exclude additional unstated elements or method steps. In any embodiment of the compositions and methods provided herein, “comprising / containing / comprising” may be replaced with “consistently consisting of” or “consisting of”. The phrase “consistently consisting of” as used herein requires the specified whole or steps and does not substantially affect the features or function of the claimed invention. As used herein, the term “composed of” is used to indicate that only the listed whole (e.g., feature, element, characteristic, property, method / process step or limitation) or a group of wholes (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) exists.

[0233] As used herein, the term "or combinations thereof" refers to all permutations and combinations of the items listed preceding the term. For example, "A, B, C, or combinations thereof" is intended to include at least one of the following: A, B, C, AB, AC, BC, or ABC, and also BA, CA, CB, CBA, BCA, ACB, BAC, or CAB if the order is important in the particular context. Continuing with this example, what is explicitly included are combinations of repeating items or terms (such as BB, AAA, AB, BBC, AAABCCCC, CBBAAA, CABABB, etc.). Those skilled in the art will understand that there is generally no limit to the number of items or terms in any combination unless it is obvious from the context.

[0234] As used herein, approximate qualifiers (such as, but not limited to, "approximately," "substantially," or "approximately") refer to conditions where, when so modified, they are not necessarily absolute or precise, but rather close enough to be considered by one of ordinary skill in the art to be sufficient to guarantee the existence of such conditions. The degree to which the description may vary will depend on how much change can be made, and that one of ordinary skill in the art will still be able to recognize the modified feature as possessing the characteristics and capabilities required to retain the unmodified feature. Generally, but subject to the preceding discussion, numerical values ​​modified herein by approximate terms (such as "approximately") may differ from the specified value by at least ±1, 2, 3, 4, 5, 6, 7, 10, 12, or 15%.

[0235] According to this disclosure, all the apparatuses and / or methods disclosed and claimed herein can be made and implemented without excessive experimentation. Although the apparatuses and methods have been described with reference to specific embodiments, it will be apparent to those skilled in the art that variations can be made to the components and / or methods described herein, as well as to the steps or sequence of steps of the methods, without departing from the concept, spirit, and scope of the invention. All such similar substitutions and modifications that will be apparent to those skilled in the art are considered to fall within the spirit, scope, and concept of the invention as defined in the appended claims.

[0236] Furthermore, the details of the construction or design shown herein are not intended to be limited except as described in the appended claims. Therefore, it is clear that the specific embodiments disclosed above can be changed or modified, and all such changes are considered to be within the scope and spirit of this disclosure. Thus, the protection sought herein is as set forth in the appended claims.

[0237] Modifications, additions, or omissions may be made to the systems and apparatus described herein without departing from the scope of the invention. Components of the systems and apparatus may be integrated or separate. Furthermore, operation of the systems and apparatus may be performed by more, fewer, or other components. Methods may include more, fewer, or other steps. Additionally, steps may be performed in any suitable order.

[0238] In order to help the Patent Office and any reader of the patent granted based on this application to interpret the appended claims, the applicant wishes to point out that, unless the terms “means for…” or “steps for…” are expressly used in a particular claim, the applicant does not intend for any appended claim to trigger section 112(f) of 35 U.SC by virtue of its existence at the date of filing.

[0239] References 1. Boachie-Adjei O, Papadopoulos EC, Pellise F, et al. (2013) Late-stage treatment of tuberculosis-associated kyphosis: a literature review and experimental findings from the SRS-GOP institution. European Journal of Spine, Vol. 22, Supplement 4: 641-6.

[0240] 2. Miladi L (2013) Round and angular kyphosis in pediatric patients. Orthopaedics & Traumatology: Surgery & Research 99S: S140-S149.

[0241] 3. Sucato DJ (2010) Management of severe spinal deformities. Spine (Phila Pa 1976) 35:2186-2192. https: / / doi.org / 10.1097 / BRS.0b013e3181feab19.

[0242] 4. Syvanen J, Helenius L, Raitio A, et al. (2022) Health-related quality of life in children after posterior spinal resection: a comparison with a healthy control group. European Journal of Orthopaedics and Traumatology. 32: 899-907.

[0243] 5. Boachie-Adjei O, Duah HO, Yankey KP, et al. (2021) New neurological deficits and recovery rates after treatment or vertebrectomy (VCR) for complex pediatric spinal deformities (over 100 degrees). Spinal Deformities. 9:427-433.

[0244] 6. Boachie-Adjei O, Duah HO, Sackeyfio A, et al. (2022) Surgical outcomes of severe spinal deformities exceeding 100° or treated with vertebroplasty (VCR). Does implant density matter: An observational study of deformity groupings. Spinal Deformities. 10: 595-606.

[0245] 7. Lenke LG, Sides BA, Koester LA, et al. (2010) Spinal resection for severe spinal deformities. Clinical Orthopaedics and Related Research 468: 687-99. https: / / doi.org / 10.1007 / s11999-009-1037-x

[0246] 8. Lenke LG, O'Leary PT, Bridwell KH, et al. (2009) Posterior spinal resection for severe childhood deformities: results of at least two years of follow-up in 35 consecutive patients. Spine (Phila Pa 1976) 34: 2213-21. https: / / doi.org / 10.1097 / BRS.0b013e3181b53cba

[0247] 9. Boachie-Adjei O, Yagi M, Nemani VM, et al. (2015) Incidence and risk factors of major surgical complications in patients with complex spinal deformities: a report from the SRS GOP site. Spinal Deformities. 3: 57-64.

[0248] 10. Lenke LG, Newton PO, Sucato DJ, et al. (2013) Complications after spinal resection in 147 consecutive children with severe spinal deformities: a multicenter analysis. Spine (Phila Pa 1976) 38: 119-32. http: / / doi.org / 10.1097 / BRS.0b013e318269fab1

[0249] 11. Suk S, Kim JH, Kim WJ, et al. (2002) Posterior spinal resection for severe spinal deformities. Spine (Phila Pa 1976) 27: 2374-2382. http: / / doi.org / 10.1097 / 00007632-200211010-0001

[0250] 12. Suk S, Chung ER, Kim JH, et al. (2005) Posterior spinal resection for severe scoliosis. Spine (Phila Pa 1976) 30: 1682-1687. http: / / doi.org / 10.1097 / 01.brs.0000170590.21071.c1

[0251] 13. Suk S, Chung ER, Lee SM, et al. (2005) Posterior spinal resection in fixed lumbosacral deformity. Spine (Phila Pa 1976) 30: E703-10.

[0252] 14. Saifi C, Laratta JL, Petridis P, et al. (2017) Spinal resection for rigid spinal deformities. Global Spine Journal 7: 280-290.

[0253] 15. Boachie-Adjei O and Yankey K (2017) Treatment of children with severe kyphosis using Halo gravity traction and spinal osteotomy: Results and complications, Annals of Pediatrics 5(3):1129.

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Claims

1. A repositioning and correction system for spinal surgery, comprising: Two single-plane fixtures; A reset rod having opposing pitch threaded ends, the reset rod being configured to connect to each of two single-plane clamps; The stabilizer bar is configured to connect to each of the two single-plane clamps; Two temporary spinal rods, each of which is configured to connect to a corresponding single-plane clamp; as well as An adjustable force compression device includes a constant force cable configured to connect to each of two single-plane clamps.

2. The reset device correction system according to claim 1, wherein, Each of the two single-plane fixtures includes a lockable differential threaded reset bolt for connecting the reset rod to the single-plane fixture.

3. The reset device correction system according to claim 1, wherein, Each of the two single-plane clamps includes a stabilizer bar locking bolt and a stabilizer bar locking nut for connecting the stabilizer bar to the single-plane clamp.

4. The reset device correction system according to claim 1, wherein, Each of the two single-plane clamps includes an open clamp, a spring-loaded snap fastener, and a temporary spine locking nut for connecting one of the temporary spine rods to the single-plane clamp.

5. The reset device correction system according to claim 1, wherein, The adjustable force compression device also includes an adjustable length mechanical base connected to the constant force cable.

6. The reset device correction system according to claim 1, wherein, The adjustable force compression device also includes a self-locking pump handle connected to the constant force cable.

7. The resetting device correction system according to claim 1, wherein, The adjustable force compression device also includes two constant force springs connected to the constant force cable.

8. A kit for a repositioning and correction system for spinal surgery, the kit comprising: Two single-plane fixtures; A reset rod having opposing pitch threaded ends, the reset rod being configured to connect to each of two single-plane clamps; The stabilizer bar is configured to connect to each of the two single-plane clamps; Two temporary spinal rods, each of which is configured to connect to a corresponding single-plane clamp; An adjustable force compression device includes a constant force cable configured to be connected to each of two single-plane clamps; as well as One or more tools for assembling or operating the reset device correction system.

9. The kit according to claim 8, wherein, Each of the two single-plane fixtures includes a lockable differential threaded reset bolt for connecting the reset rod to the single-plane fixture.

10. The kit according to claim 8, wherein, Each of the two single-plane clamps includes a stabilizer bar locking bolt and a stabilizer bar locking nut for connecting the stabilizer bar to the single-plane clamp.

11. The kit according to claim 8, wherein, Each of the two single-plane clamps includes an open clamp, a spring-loaded snap fastener, and a temporary spine locking nut for connecting one of the temporary spine rods to the single-plane clamp.

12. The kit according to claim 8, wherein, The adjustable force compression device also includes an adjustable length mechanical base connected to the constant force cable.

13. The kit according to claim 8, wherein, The adjustable force compression device also includes a self-locking pump handle connected to the constant force cable.

14. The kit according to claim 8, wherein, The adjustable force compression device also includes two constant force springs connected to the constant force cable.

15. A method of using a repositioning and correction system for spinal surgery, the method comprising: Position the patient who needs spinal surgery. Provide the reset device correction system, the system comprising: Two single-plane fixtures; A reset rod having opposing pitch threaded ends, the reset rod being configured to connect to each of two single-plane clamps; The stabilizer bar is configured to connect to each of the two single-plane clamps; Two temporary spinal rods, each configured to connect to a corresponding single-plane clamp; and An adjustable force compression device includes a constant force cable configured to connect to each of two single-plane clamps; and Spinal surgery is performed using the aforementioned repositioning device correction system.

16. The method according to claim 15, wherein, Each of the two single-plane fixtures includes a lockable differential threaded reset bolt for connecting the reset rod to the single-plane fixture.

17. The method according to claim 15, wherein, Each of the two single-plane clamps includes a stabilizer bar locking bolt and a stabilizer bar locking nut for connecting the stabilizer bar to the single-plane clamp.

18. The method according to claim 15, wherein, Each of the two single-plane clamps includes an open clamp, a spring-loaded snap fastener, and a temporary spine locking nut for connecting one of the temporary spine rods to the single-plane clamp.

19. The method according to claim 15, wherein, The adjustable force compression device also includes an adjustable length mechanical base connected to the constant force cable.

20. The method of claim 15, wherein, The adjustable force compression device also includes a self-locking pump handle connected to the constant force cable.

21. The method according to claim 15, wherein, The adjustable force compression device also includes two constant force springs connected to the constant force cable.

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