Systems, devices, and methods for treating scoliosis

Abstract

Systems for correcting scoliosis are provided that can include a plurality of screws configured to be implanted in a plurality of vertebrae, and a plurality of extensions configured to be removably coupled with the plurality of screws. Some embodiments of the plurality of extensions can be curved, bent, angled, and / or offset along at least a portion thereof, and can be removably coupled with a screw head of each of the plurality of screws. The system can include a connecting element or rod configured to be coupled with the plurality of screw heads. Some embodiments of the system can be configured such that the rod can be guided along the plurality of extensions from a proximal end to a distal portion of the extensions, and engaged with the plurality of screws to cause lateral movement of the plurality of vertebrae.

Description

[0001] Priority Claims and Incorporation by Reference

[0002] This application claims priority to U.S. Patent Application No. 62 / 941,641, filed November 27, 2019, entitled “SYSTEMS AND METHODS FOR CORRECTING A LATERAL CURVATURE OF A SPINE,” the contents of which are incorporated by reference in their entirety as if fully set forth herein. Priority is claimed under appropriate legal basis including, but not limited to, 35 U.S.C. § 119(e). BACKGROUND

[0003] The spine or vertebral column has a natural curvature. The cervical and lumbar spines generally have an anterior convex sagittal alignment, while the thoracic spine generally has a posterior convex alignment. Changes in the typical spinal alignment curvature often occur within a “normal” range; however, “pathological” or abnormal curvatures and alignments can occur. If the normal curvature of the spine is too great, a kyphotic deformity or hyperlordosis occurs. On the other hand, if the normal curvature is reduced, the spine is more straight and a flat back condition is seen. If the curvature is further reduced and bends in the opposite direction, the lordosis becomes kyphosis or the kyphosis becomes lordosis. It is common to observe a reversal of the normal spinal lordosis to kyphosis in the cervical spine and sometimes in the lumbar spine. Abnormal curvature of the spine can also be caused by pathological conditions such as tumors, fractures, and congenital conditions such as embryological malformations and tethered spinal cord, among others.

[0004] Scoliosis and kyphosis describe spinal alignment in the sagittal plane. In the coronal plane, abnormal curvature can also occur and is referred to as scoliosis. Typically, the spine is straight in the coronal plane. Scoliosis typically involves the thoracic and lumbar spines. In fact, scoliosis is not limited to a single (coronal) plane, but often involves three-dimensional curvature and can even include rotational curvature. Scoliosis can occur as idiopathic adolescent scoliosis, which typically involves patients between 10-18 years of age. Scoliosis can also occur in adults in the form of degenerative scoliosis.

[0005] Treatment of patients with spinal alignment and curvature abnormalities is a complex patient-centered approach. First, individualized treatment plans are implemented, including conservative treatment physical therapy, anti-inflammatory medications, and pain management. For adolescent idiopathic scoliosis, thoracolumbar braces are also used. Surgical treatment of adolescent idiopathic scoliosis is primarily centered around correction of the clinical deformity, psychological impact of the body deformity, and risk of deformity progression after skeletal maturity. Patients with idiopathic adolescent scoliosis typically do not have significant pain or altered function. In contrast, for adults with degenerative scoliosis, pain and altered function are often the primary motivation. Degenerative spinal disease often presents with multiple symptoms and findings, including stenosis with claudication, radiculopathy, axial back pain, disc herniation, spondylolisthesis, and sagittal imbalance, lateral misalignment, and scoliosis. Thus, the surgical goals can be different for adolescent versus degenerative scoliosis patients.

[0006] Surgical treatment techniques for scoliosis generally include restoration of alignment through spinal fusion. Both anterior and posterior instrumentation can be used. For adolescent idiopathic scoliosis, the spine is generally flexible, so correction can be performed through pedicle screw manipulation, through bending and rotation of the rod, compression and distraction of the screws on the rod, and rod retraction into the screw heads. When the spine is less flexible in the case of degenerative scoliosis, various forms of osteotomy, facetectomy, and in-body fusion can be performed to help alignment and restoration of curvature of the spine.

[0007] One of the basic techniques for restoration of scoliosis curvature is rod bending. After placement of pedicle screws, a rod is bent to fit into the screw heads of the curved spine. The rod is partially but loosely locked by placing a screw cap or another locking device on the rod. The rod is then rotated so that the convex side of the rod is rotated laterally posteriorly (dorsally), thereby restoring thoracic kyphosis. In this way, the final curvature of the spine approximates an axial rotation of the original curvature, so that the convex curvature becomes the apex of the final posterior convex curve. There also exist in situ benders, which can bend the rod after placement into the screw heads.

[0008] There are several problems with rod bending. The main complication that can occur after scoliosis surgery is rod breakage or cracking. Although several factors contribute to rod breakage, one of the preventable factors is rod bending, which weakens the metal rod and causes a weak point in the rod. Rod bending increases the risk of rod breakage. (Lindsey C, Deviren V, Xu Z, et al. 2006 - The effects of rod contouring on spinal construct fatigue strength. Spine Z 1 : 1680-1687) (Demura et al 2015 Orthopedics 38(6):e520. Influence of rod contouring on rod strength and stiffness in spine surgery. f ). Rod breakage has been reported as a complication of scoliosis surgery, from 10-15% of patients to as high as 25% of patient populations (Buell et al 2019 J Neurosurgery Spine 21 : 1-14 Surgical correction of severe adult lumbar scoliosis (major curves >75°): retrospective analysis with minimum 2-year follow-up).

[0009] Traditional techniques for reducing spinal curvature cannot be performed without rod bending. This is because in scoliosis or deformity surgery, the spine is abnormally curved, and the rod is bent to approximate the abnormal curvature in order to "fit" into the pedicle screws or extension portions (also referred to herein as towers or leader members) that are connected to pedicle screws that have been placed into the curved vertebrae. Thus, the rod is bent to accommodate the curve.

[0010] In an ideal situation, the opposite is the goal. The vertebrae should be bent to accommodate the rod. Thus, the abnormally curved vertebrae should be bent to conform to the final shape of the ideal rod without bending the rod. To date, no method or device has been identified that is capable of achieving this idealized correction of spinal deformity and scoliosis.

[0011] The“normal” cervical thoracolumbar curvature of the spine can be generated from average radiographic data. However, patients have all shapes and sizes and curvatures. Ideally, deformity and scoliosis surgery corrects all spinal deformity to an ideal curvature guided by a pre-bent rod. In the real world, individuals vary, including height, age, curvature, anatomical and congenital abnormalities, deformity severity, osteoporosis, etc. Some curves of the spine are too extreme in geometry or degree of flexibility to be fully corrected because the force required to make a full correction can cause fractures of the vertebrae, pedicles, lamina, etc., or nerve injury due to abnormal motion and displacement during correction. Computational models have been developed that can predict the optimal 3-dimensional shape of a rod for each individualized rod (Kokabu et al 2018 J. Orthop. Res 36:3219-3224 Identification of optimized rod shapes to guide anatomical spinal reconstruction for adolescent thoracic idiopathic scoliosis). Other methods have utilized artificial intelligence (AI) and machine learning to optimize rod shaping preoperatively.

[0012] SUMMARY OF SOME EMBODIMENTS

[0013] Embodiments of systems, devices, and methods for correcting scoliosis are disclosed herein. Hereinafter, systems, devices, and methods for correcting scoliosis can also be referred to as systems, devices, and methods for treating spinal defects and / or systems, devices, and methods.

[0014] Some embodiments of systems, devices, and methods can include a plurality of screws configured to be implanted into a plurality of vertebrae, and a plurality of extensions (which can also be referred to herein as guide members) configured to be detachably coupled with the plurality of screws. The plurality of extensions can be curved along at least a portion thereof, and can be detachably coupled with a screw head of each of the plurality of screws. In some embodiments, one or more extensions can be curved along all or substantially all of the length of the extension. Further, the systems, devices, and methods can include a connecting element or rod configured to be coupled with the plurality of screw heads. Some implementations can be configured such that the rod can be guided along the plurality of extensions (e.g., but not limited to, along a channel extending along the length of the extension) from a proximal end of the extension toward a distal end of the extension and into engagement with the plurality of screws to cause lateral movement of the plurality of vertebrae.

[0015] Some embodiments of the systems, devices, and methods disclosed herein for treating scoliosis can include a plurality of screws configured to be implanted in a plurality of vertebrae, each of the plurality of screws having a screw head, a plurality of extensions configured to be detachably coupled with the plurality of screws, each of the plurality of extensions having a proximal end portion, a distal end portion configured to be detachably coupled with the screw head of each of the plurality of screws, and an intermediate portion between the proximal end portion and the distal end portion, and a rod configured to be coupled with the plurality of screw heads.

[0016] In further embodiments, any embodiment of the systems, devices, and / or methods disclosed herein can include one or more of the following features, components, and / or details, in any combination with any other feature, component, and / or detail disclosed herein: wherein an axial centerline of a proximal portion of at least one extension can be at a different angle than an axial centerline of a distal portion of at least one extension; wherein the device can be configured such that the rod can be guided along the plurality of extensions from a proximal end of the plurality of extensions toward a distal end of the plurality of extensions and into engagement with the plurality of screws; wherein at least the middle portion of the plurality of extensions is curved; wherein at least the middle portion of the plurality of extensions is curved; wherein an angle of the axial centerline of the proximal portion of at least one of the extensions relative to the axial centerline of the distal portion can be adjusted by a surgeon during treatment of the scoliosis procedure; wherein at least one of the extensions can be locked in a desired angular position after adjustment of the angle of the axial centerline of the proximal portion of at least one of the extensions relative to the axial centerline of the distal portion; wherein an angle of the axial centerline of a proximal portion of at least one extension relative to an axial centerline of a distal portion can be adjusted by a robot during treatment of the scoliosis procedure; wherein an axial centerline of a proximal portion of at least two of the extensions is at a different angle than an axial centerline of the distal portion of the at least two of the extensions; wherein the device can include a first extension, wherein the axial centerline of the proximal portion of the first extension is at a first angle relative to the axial centerline of the distal portion of the first extension, wherein the first angle is greater than zero; wherein the device can include a second extension, wherein the axial centerline of the proximal portion of the second extension is at a second angle relative to the axial centerline of the distal portion of the second extension, wherein the second angle is greater than the first angle; wherein the device can include a third extension, wherein the axial centerline of the proximal portion of the third extension is at a third angle relative to the axial centerline of the distal portion of the third extension, wherein the third angle is greater than the second angle; wherein the device can include a fourth extension and a fifth extension, wherein the axial centerline of the proximal portion of the fourth extension is at a fourth angle relative to the axial centerline of the distal portion of the fourth extension, the fourth angle being greater than the third angle, the axial centerline of the proximal portion of the fifth extension is at a fifth angle relative to the axial centerline of the distal portion of the fifth extension, the fifth angle being greater than the fourth angle; wherein the device can include a sixth extension, wherein the axial centerline of the proximal portion of the sixth extension is collinear with the axial centerline of the distal portion of the sixth extension;wherein the device is configured to move one or more vertebrae in a lateral direction when the rod is advanced toward the distal ends of the plurality of extensions and engages the plurality of screw heads; wherein the device is configured to move one or more vertebrae toward a lateral centerline of the spinal column when the rod is advanced toward the distal ends of the plurality of extensions; wherein the device is configured such that the rod can be simultaneously advanced down the plurality of extensions by incrementally advancing the rod toward the distal end of each of the plurality of extensions; wherein the rod is generally straight in at least one lateral direction; and / or wherein the plurality of extensions have different lengths; and / or wherein the plurality of extensions have varying curvatures such that a curvature of a first extension of the plurality of extensions is different than a curvature of a second extension of the plurality of extensions.

[0017] Further, in additional embodiments, any embodiment of the systems, devices, and / or methods disclosed herein can include one or more of the following features, components, and / or details, in any combination with any other feature, component, and / or detail of any other embodiment disclosed herein: wherein each of the plurality of extensions has a slot extending therefrom from a proximal portion of each of the plurality of extensions toward a distal portion of each of the plurality of extensions, wherein the slot of each of the plurality of extensions is configured to slidably house the rod therein such that the rod can be guided toward the plurality of screw heads via the slots of the plurality of extensions; wherein the device can include a plurality of pushing elements configured to be advanced along the slots between the proximal portion and the distal portion of each of the plurality of extensions; wherein the slot of each of the plurality of extensions has internal threading therein configured to threadably engage a plurality of threaded pushing elements that are threadably advanceable in the slots toward the distal portions of the plurality of extensions to cause the rod to advance toward the plurality of screw heads; wherein the device can include a plurality of pushing elements configured to be coupled with the plurality of extensions and to selectively move the rod downward toward the distal portions of the plurality of extensions toward the plurality of screw heads as the plurality of pushing elements are advanced toward the distal portions of the plurality of extensions; wherein each of the plurality of pushing elements is selectively biased to resist movement toward the proximal portions of the plurality of extensions as the plurality of pushing elements are advanced toward the distal portions of the plurality of extensions; wherein the device can include a plurality of threaded screws configured to threadably engage the plurality of extensions and to selectively move the rod downward toward the distal portions of the plurality of extensions toward the plurality of screw heads as the plurality of screws are threadably advanced toward the distal portions of the plurality of extensions; wherein the device is configured to resist movement of the rod toward the proximal portions of each of the plurality of extensions as the rod is advanced toward the distal portions of each of the plurality of extensions; wherein the device can include a plurality of guiding elements configured to be coupled with the rod and to slide along the plurality of extensions from the proximal portions of each of the plurality of extensions toward the distal portions of each of the plurality of extensions to guide the rod toward the plurality of screw heads; and / or wherein at least one of the plurality of extensions is substantially straight along a length of the extension.

[0018] Further, in additional embodiments, any embodiment of the systems, devices, and / or methods disclosed herein can include one or more of the following features, components, and / or details in any combination with any other feature, component, and / or detail of any other embodiment disclosed herein: wherein the plurality of screws includes a first plurality of screws and a second plurality of screws, the device is configured such that each of the first plurality of screws is to be implanted in a plurality of vertebrae adjacent (e.g., bilaterally adjacent) to each of the second plurality of screws, the plurality of extensions includes a first plurality of extensions and a second plurality of extensions, each of the first plurality of extensions is configured to be detachably coupled with a screw head of each of the first plurality of screw heads, each of the second plurality of extensions is configured to be detachably coupled with a screw head of each of the second plurality of screw heads, the rod is a first rod, and the device includes a second rod, and the device is configured such that the first rod is directable along the first plurality of extensions from the proximal end portion of the first plurality of extensions toward the distal end portion of the first plurality of extensions and into engagement with the first plurality of screws, and such that the second rod is directable along the second plurality of extensions from the proximal end portion of the second plurality of extensions toward the distal end portion of the second plurality of extensions and into engagement with the second plurality of screws; wherein the device can include a first screw having a first screw head; a second screw having a second screw head; a third screw having a third screw head; a first extension having a proximal end portion, a distal end portion configured to be detachably coupled with the first screw head, and a body portion between the proximal end portion and the distal end portion, wherein at least a portion of the first extension is curved; a second extension having a proximal end portion, a distal end portion configured to be detachably coupled with the second screw head, and a body portion between the proximal end portion and the distal end portion, wherein at least a portion of the second extension is curved; and a third extension having a proximal end portion, a distal end portion configured to be detachably coupled with the third screw head, and a body portion between the proximal end portion and the distal end portion, wherein at least a portion of the third extension is curved; wherein the body portion of the first extension has a first curvature, the body portion of the second extension has a second curvature, and the second curvature is different from the first curvature; wherein the body portion of the second extension has a second curvature, the body portion of the third extension has a third curvature, and the third curvature is different from the second curvature; wherein the plurality of extensions has at least four different curvatures and / or lengths; wherein the device can include a plurality of locking caps, each locking cap configured to engage with a screw head of each screw of the plurality of screws; and / or wherein the device can include a plurality of torque or pressure sensors, wherein each of the torque or pressure sensors is coupled with the plurality of extensions and configured to operably measure an amount of strain at the plurality of extensions.

[0019] Also disclosed herein are embodiments of systems and devices for treating a scoliosis, which can include a plurality of screws configured to be implanted in a plurality of vertebrae, having a plurality of screw heads, and a plurality of extensions configured to be detachably coupled with the plurality of screws, each of the plurality of extensions having a proximal portion, a distal portion configured to be detachably coupled with a screw head of each of the plurality of screws, and an intermediate portion between the proximal portion and the distal portion.

[0020] In further embodiments, any embodiment of the apparatuses, systems, and / or methods disclosed herein can include one or more of the following features, components, and / or details in any combination with any other feature, component, and / or detail of any other embodiment disclosed herein: wherein the proximal portion of a first extension of the plurality of extensions is laterally spaced apart or offset from the distal portion of the first extension by a first distance when the first extension is coupled with a first vertebra in an operable position, the proximal portion of a second extension of the plurality of extensions is laterally spaced apart from the distal portion of the second extension by a second distance when the second extension is coupled with a second vertebra in an operable position, and the second distance is greater than the first distance; wherein at least one of the first distance of the first extension and the second distance of the second extension is adjustable by a surgeon during treatment of the scoliosis; wherein at least one of the first distance of the first extension and the second distance of the second extension is adjustable by a robot during treatment of the scoliosis; wherein the proximal portion of a third extension of the plurality of extensions is laterally spaced apart from the distal portion of the third extension by a third distance when the third extension is coupled with a third vertebra in an operable position, and the third distance is greater than the second distance; wherein the proximal portion of a fourth extension of the plurality of extensions is laterally spaced apart from the distal portion of the fourth extension by a fourth distance when the fourth extension is coupled with a fourth vertebra in an operable position, the proximal portion of a fifth extension of the plurality of extensions is laterally spaced apart from the distal portion of the fifth extension by a fifth distance when the fifth extension is coupled with a fifth vertebra in an operable position, the fourth distance is greater than the third distance, and the fifth distance is greater than the fourth distance; wherein at least the intermediate portion of the plurality of extensions is curved, bent, and / or angled; and / or wherein the plurality of extensions includes a substantially straight extension.

[0021] Further, in any of the embodiments disclosed herein, in any of the embodiments disclosed herein, the distal end portion of at least one of the plurality of extensions can be flexibly coupled with the respective screw and / or screw head. For example, and without limitation, the system can be configured such that at least one of the plurality of extensions (or, in other embodiments, all of the plurality of extensions) is configured to rotate in a transverse direction (or at least in a transverse direction) relative to the respective screw to which the extension is coupled, where the transverse direction is a direction in a plane that is perpendicular to the spinal column centerline. For example, and without limitation, the extension can be configured to rotate in the transverse direction relative to an axial centerline of the respective screw in a range of 20 degrees or about 20 degrees, or in a range of 10 degrees or about 10 degrees, where the transverse direction is a direction in a plane that is perpendicular to the spinal column centerline. In any of the embodiments, the system can be configured wherein the distal end portion of each of the plurality of extensions is configured to be rigidly coupled with a respective one of the plurality of screws and / or a respective one of the plurality of screw heads such that at least the distal end portion of each of the plurality of extensions is axially aligned with the respective screw and / or screw head and is blocked from rotating relative to each of the plurality of screws in the operable position.

[0022] Further, in additional embodiments, any embodiment of the devices, systems, and / or methods disclosed herein can include one or more of the following features, components, and / or details, as well as any combination of any other feature, component, and / or detail of any other embodiment disclosed herein: wherein the device can include a rod configured to couple with the plurality of screw heads. Wherein the device is configured to move one or more vertebrae in a lateral direction when the rod is advanced toward the distal ends of the plurality of extensions and engages with the plurality of screw heads; wherein the device is configured such that the rod can be advanced down the plurality of extensions simultaneously by incrementally advancing the rod toward the distal ends of each of the plurality of extensions; wherein the rod is generally straight in at least the lateral direction; wherein the plurality of extensions have different lengths; wherein each of the plurality of extensions has a slot therein extending from the proximal end of each of the plurality of extensions toward the distal end of each of the plurality of extensions, wherein the slot of each of the plurality of extensions is configured to slidably house the rod therein such that the rod can be guided through the slots of the plurality of extensions toward the plurality of screw heads; wherein the device can include a plurality of pushing elements configured to advance along the slots between the proximal end and the distal end of each of the plurality of extensions; wherein the device can include a plurality of pushing elements configured to couple with the plurality of extensions and selectively move the rod down the distal ends of the plurality of extensions toward the plurality of screw heads as the plurality of pushing elements are advanced toward the distal ends of the plurality of extensions; and / or wherein the device can include a plurality of threaded screws configured to threadably engage with the plurality of extensions and selectively move the rod down the distal ends of the plurality of extensions toward the plurality of screw heads as the plurality of screws are threadably advanced toward the distal ends of the plurality of extensions.

[0023] Some embodiments of the systems, devices, and methods for treating scoliosis disclosed herein can include a plurality of screws configured to be implanted in a plurality of vertebrae, each of the plurality of screws having a screw head; a plurality of curved or bent extensions configured to be removably coupled with the plurality of screws, each of the plurality of curved or bent extensions having a proximal end, a distal end configured to be removably coupled with the screw head of each of the plurality of screws, and a body portion between the proximal end and the distal end, wherein the plurality of extensions are curved or bent along at least a portion thereof; and a rod configured to couple with the plurality of screw heads.

[0024] In further embodiments, any embodiment of the devices, systems, and / or methods disclosed herein can include one or more of the following features, components, and / or details, in any combination with any other feature, component, and / or detail disclosed herein: wherein the system can be configured such that the rod can be directed along the plurality of curved or bent extensions from a proximal end of the plurality of curved or bent extensions toward a distal end of the plurality of curved or bent extensions and into engagement with the plurality of screws; wherein the system can be configured to move one or more vertebrae in a lateral direction when the rod is advanced toward the distal end of the plurality of curved or bent extensions and into engagement with the plurality of screw heads; wherein the system can be configured such that the rod can be simultaneously advanced down the plurality of curved or bent extensions by incrementally advancing the rod toward the distal end of each of the plurality of curved or bent extensions; wherein the system can be configured to move one or more vertebrae toward a lateral centerline of the spinal column when the rod is advanced toward the distal end of the plurality of curved or bent extensions; wherein the rod can be generally straight in a lateral direction; wherein the plurality of curved or bent extensions can have different lengths; wherein the plurality of curved or bent extensions can have varying curvatures; and / or wherein each of the plurality of curved or bent extensions can have a slot therein extending from a proximal end of each of the plurality of curved or bent extensions toward a distal end of each of the plurality of curved or bent extensions, wherein the slot of each of the plurality of curved or bent extensions can be configured to slidably house the rod therein such that the rod can be directed toward the plurality of screw heads using the slots in the plurality of curved or bent extensions.

[0025] Further, in additional embodiments, any embodiment of the systems, devices, and / or methods disclosed herein can include one or more of the following features, components, and / or details, in any combination with any other feature, component, and / or detail of any other embodiment disclosed herein: including a plurality of pushing elements configured to couple with the plurality of curved or bent extensions and to selectively move the rod downward toward the distal end of the plurality of curved or bent extensions toward the plurality of screw heads when the plurality of pushing elements are advanced toward the distal end of the plurality of curved or bent extensions; wherein each of the plurality of pushing elements is selectively biased to resist movement toward the proximal end of the plurality of curved or bent extensions when the plurality of pushing elements are advanced toward the distal end of the plurality of curved or bent extensions; further including a plurality of threaded pushing elements configured to threadably engage with the plurality of curved or bent extensions and to selectively move the rod downward toward the distal end of the plurality of curved or bent extensions toward the plurality of screw heads when the plurality of pushing elements are threadably advanced toward the distal end of the plurality of curved or bent extensions; wherein the plurality of threaded pushing elements can be a plurality of screws; wherein each of the plurality of curved or bent extensions can have a slot therein extending from a proximal end of each of the plurality of curved or bent extensions toward a distal end of each of the plurality of curved or bent extensions, wherein the slot of each of the plurality of curved or bent extensions can be configured to slidably house the rod therein such that the rod can be guided toward the plurality of screw heads using the slots in the plurality of curved or bent extensions; further including a plurality of pushing elements configured to engage with the slot of each of the plurality of extensions; wherein the slot of each of the plurality of curved or bent extensions has internal threads configured to threadably engage with a plurality of threaded pushing elements that can be threadably advanced in the slot toward the distal end of the plurality of curved or bent extensions to advance the rod toward the plurality of screw heads; wherein the system can be configured to selectively prevent the rod from moving toward the proximal end of each of the plurality of curved or bent extensions when the rod is advanced toward the distal end of each of the plurality of curved or bent extensions; further including a plurality of guide elements configured to couple with the rod and to slide along the plurality of curved or bent extensions from a proximal end of each of the plurality of curved or bent extensions toward a distal end of each of the plurality of curved or bent extensions to guide the rod toward the plurality of screw heads; and / or wherein at least one of the plurality of curved or bent extensions has at least one approximately straight portion along the length of the curved or bent extension.

[0026] Further, any embodiment of the system, device, and / or method disclosed herein can include one or more of the following features, components, and / or details in additional embodiments, in any combination with any other feature, component, and / or detail of any other embodiment disclosed herein: wherein the plurality of screws can include a first plurality of screws and a second plurality of screws, the system can be configured such that each of the first plurality of screws is to be implanted in a plurality of vertebrae adjacent to each of the second plurality of screws, the plurality of curved or bent extensions can include a first plurality of curved or bent extensions and a second plurality of curved or bent extensions, each of the first plurality of curved or bent extensions can be configured to be detachably coupled with a screw head of each of the first plurality of screws; each of the second plurality of curved or bent extensions can be configured to be detachably coupled with a screw head of each of the second plurality of screw heads, the rod is a first rod, and the system can include a second rod, and the system can be configured such that the first rod can be guided along the first plurality of curved or bent extensions from a proximal end of the first plurality of curved or bent extensions toward a distal end of the first plurality of curved or bent extensions and engage the first plurality of screws, and such that the second rod can be guided along the second plurality of curved or bent extensions from a proximal end of the second plurality of curved or bent extensions toward a distal end of the second plurality of curved or bent extensions and engage the second plurality of screws; further comprising a first screw having a first screw head; a second screw having a second screw head; a third screw having a third screw head; a first extension having a proximal end, a distal end configured to be detachably coupled with the first screw head, and a body portion between the proximal end and the distal end, wherein at least a portion of the first extension is curved or bent; a second extension having a proximal end, a distal end configured to be detachably coupled with the second screw head, and a body portion between the proximal end and the distal end, wherein at least a portion of the second extension is curved or bent; a third extension having a proximal end, a distal end configured to be detachably coupled with the third screw head, and a body portion between the proximal end and the distal end, wherein at least a portion of the third extension is curved or bent, wherein the body portion of the first extension has a first curvature, the body portion of the second extension has a second curvature, and the second curvature is different from the first curvature; wherein the body portion of the second extension has a second curvature, the body portion of the third extension has a third curvature, and the third curvature is different from the second curvature; wherein the plurality of curved or bent extensions has at least four different curvatures and / or lengths; and / or further comprising a plurality of locking caps, each locking cap configured to engage a screw head of each of the plurality of screws.

[0027] Some embodiments of the systems, devices, and methods disclosed herein for treating scoliosis can include a plurality of rod lowering devices configured to assist in rod lowering into the plurality of screw heads, each rod lowering device including a body portion having a channel configured to receive a respective one of a plurality of extensions therein as the rod lowering device passes over the plurality of extensions, and a contact member configured to translate along a length of the body portion of each of the rod lowering devices and to be detachably coupled with the rod, the rod being configurable to be coupled with the plurality of screw heads.

[0028] In further embodiments, any embodiment of the systems, devices, and / or methods disclosed herein can include one or more of the following features, components, and / or details, in any combination with any other feature, component, and / or detail of any other embodiment disclosed herein: wherein each body portion has a distal end portion configured to be detachably coupled with a distal end portion of a respective one of the screws, a respective one of the screw heads, and / or a respective one of the extensions; wherein the rod lowering devices are configured to move the rod toward the screw heads as the contact members move toward the screw heads; wherein the body portion of one or more of the rod lowering devices has one or more grooves along a length thereof, wherein each of the grooves is configured to accommodate a portion of the contact member therein as the contact member is advanced along the length of the body portion of the respective rod lowering device; wherein the body portion of one or more of the rod lowering devices has one or more grooves along a length thereof, wherein each of the grooves is configured to accommodate a protrusion or wheel of the contact member therein as the contact member is advanced along the length of the body portion of the respective rod lowering device; wherein the rod lowering devices are all straight; wherein the rod lowering devices are all curved; wherein the contact member is configurable to roll or slide relative to the body portion, wherein the channel is threaded; further comprising a nut configured to be threadably advanced down the channel toward the screw heads and configured to be threadably coupled with each of the plurality of screw heads to secure the rod to the plurality of screw heads; further comprising a force sensor coupled with the rod lowering devices, the force sensor being configured to measure a level of force applied to the rod; and / or further comprising a torque sensor configured to measure a level of torque applied to the nut.

[0029] Some embodiments of the systems, devices, and methods disclosed herein for treating scoliosis can include a plurality of screws each configured to be implanted in a respective one of a plurality of vertebrae, each of the plurality of screws having a screw head; and a plurality of extensions each configured to be detachably coupled with a respective one of the plurality of screws, each of the plurality of extensions having a first guide configured to be coupled with a first side of the screw head and a second guide configured to be coupled with a second side of the screw head, the second side being opposite the first side, and wherein the first guide and the second guide diverge laterally outward away from a centerline axis of the device such that a width between proximal portions of the first guide and the second guide is greater than a width between distal portions of the first guide and the second guide.

[0030] In further embodiments, any embodiment of the systems, devices, and / or methods disclosed herein can include one or more of the following features, components, and / or details, in any combination with any other feature, component, and / or detail of any other embodiment disclosed herein: wherein, in the operation of treating scoliosis, the width between the proximal portions of the first guide and the second guide can be adjusted by a surgeon, wherein, in the course of treating scoliosis, the width between the proximal portions of the first guide and the second guide can be adjusted by a robot; further comprising a first extension and a second extension, wherein the width between the proximal portions of the first guide and the second guide of the first extension is less than the width between the proximal portions of the first guide and the second guide of the second extension; further comprising a third extension, wherein the width between the proximal portions of the first guide and the second guide of the second extension is less than the width between the proximal portions of the first guide and the second guide of the third extension; further comprising a fourth extension, wherein the width between the proximal portions of the first guide and the second guide of the third extension is less than the width between the proximal portions of the first guide and the second guide of the fourth extension; further comprising a fifth extension, wherein the width between the proximal portions of the first guide and the second guide of the fourth extension is less than the width between the proximal portions of the first guide and the second guide of the fifth extension; further comprising a sixth extension, wherein the width between the proximal portions of the first guide and the second guide of the fifth extension is less than the width between the proximal portions of the first guide and the second guide of the sixth extension; wherein at least a portion of the first and second guides are curved, bent, and / or angled; wherein the plurality of extensions can include substantially straight extensions; and / or further comprising a rod that can be configured to be coupled with the plurality of screw heads, wherein the system can be configured to move one or more vertebrae in a lateral direction when the rod is advanced toward distal portions of the plurality of extensions and engages with the plurality of screw heads.

[0031] Some embodiments of the systems, devices, and methods for treating scoliosis disclosed herein can include a plurality of screws each configured to be implanted into a respective one of a plurality of vertebrae, each of the plurality of screws having a screw head; a plurality of extensions each configured to be detachably coupled at a distal end portion thereof with a respective one of the plurality of screws and / or screw heads; a plurality of guide members configured to be coupled with a proximal end portion of each of the plurality of extensions; and an alignment element configured to be advanced over the plurality of guide members, wherein the system is configured to move one or more vertebrae toward a transverse centerline of the spine as the alignment element is advanced toward the distal end portions of the plurality of guide members.

[0032] In further embodiments, any embodiment of the systems, devices, and / or methods disclosed herein can include one or more of the following features, components, and / or details in combination with any other feature, component, and / or detail of any other embodiment disclosed herein: a proximal end portion of a first guide member of the plurality of guide members is laterally spaced apart from a distal end portion of the first guide member by a first distance when the first guide member is coupled with a first extension of the plurality of extensions in an operable position; wherein a proximal end portion of a second guide member of the plurality of guide members is laterally spaced apart from a distal end portion of the second guide member by a second distance when the second guide member is coupled with a second extension of the plurality of extensions in an operable position, and wherein the second distance is greater than the first distance; wherein at least one of the first distance of the first guide member and the second distance of the second guide member is adjustable by a surgeon in the operation to treat the spinal scoliosis; wherein at least one of the first distance of the first guide member and the second distance of the second guide member is adjustable by a robot in the operation to treat the spinal scoliosis; wherein a proximal end portion of a third guide member of the plurality of guide members is laterally spaced apart from a distal end portion of the third guide member by a third distance when the third guide member is coupled with a third extension in an operable position, and the third distance is greater than the second distance; wherein a proximal end portion of a fourth guide member of the plurality of guide members is laterally spaced apart from a distal end portion of the fourth guide member by a fourth distance when the fourth guide member is coupled with a fourth extension in an operable position, and the fourth distance is greater than the third distance; wherein a proximal end portion of a fifth guide member of the plurality of guide members is laterally spaced apart from a distal end portion of the fifth guide member by a fifth distance when the fifth guide member is coupled with a fifth extension in an operable position, and the fifth distance is greater than the fourth distance; wherein the system is configured such that the plurality of guide members are positioned entirely outside of the operable position of the patient's body; wherein the system is configured such that the alignment element is positioned entirely outside of the patient's body when the alignment element is in the operable position adjacent to the distal end portions of the plurality of guide members; and / or wherein the plurality of guide members comprise curved, bent, and / or angled guide members; wherein the plurality of guide members are curved; wherein the plurality of guide members comprise at least one substantially straight guide member.

[0033] Further, in additional embodiments, any embodiment of the systems, devices, and / or methods disclosed herein can include one or more of the following features, components, and / or details, in any combination with any other feature, component, and / or detail of any other embodiment disclosed herein: further comprising a rod configured to couple with the plurality of screw heads to prevent the one or more vertebrae from moving away from a transverse centerline of the spinal column; wherein the rod is generally straight in at least one transverse direction; wherein each of the plurality of extensions has a slot extending therefrom proximal end portion of each of the plurality of extensions toward the distal end portion of each of the plurality of extensions, wherein the slot of each of the plurality of extensions is configured to slidably house the rod therein such that the rod can be guided through the slots of the plurality of extensions toward the plurality of screw heads; further comprising a plurality of caps configured to be advanced through each of the plurality of extensions to move the rod toward the plurality of screw heads; and / or wherein a distal end portion of each of the plurality of guide members is coupled with a proximal end of the plurality of extensions at a location that is laterally offset from an axial centerline of the plurality of extensions.

[0034] Some embodiments of the systems, devices, and methods for treating a lateral curvature of a spinal column disclosed herein can include a plurality of screws configured to be implanted in a plurality of vertebrae, each of the plurality of screws having a screw head; a plurality of curved or bent guide elements, each guide element configured to be fixed relative to a respective screw, each of the plurality of curved or bent guide elements having a proximal end and a distal end; and a rod configured to be guided along the plurality of curved or bent guide elements from the proximal ends of the plurality of curved or bent guide elements toward the distal ends of the plurality of curved or bent guide elements, wherein the system is configured such that the guiding of the rod along the plurality of curved or bent guide elements causes the plurality of vertebrae to move to correct the lateral curvature of the spinal column.

[0035] In further embodiments, any embodiment of the systems, devices, and / or methods disclosed herein can include one or more of the following features, components, and / or details, as well as any combination of any other features, components, and / or details of any other embodiment disclosed herein: the distal ends of the plurality of curved or bent guide elements are each configured to be fixed relative to a screw head of a respective screw, the rod is configured to be guided by the plurality of curved or bent guide elements into the screw heads of the plurality of screws; a plurality of towers, each tower having a proximal end and a distal end, wherein the distal ends of the plurality of towers are each configured to be fixed relative to a screw head of a respective screw, and the distal ends of the plurality of curved or bent guide elements are each configured to be fixed to the proximal end of a respective tower; each of the plurality of towers includes an opening or slot configured to guide a spinal fixation rod into the screw heads of the plurality of screws; further comprising a spinal fixation rod, wherein the spinal fixation rod is separate from the rod, the rod is configured to be guided along the plurality of curved or bent guide elements; wherein each of the plurality of towers further comprises a preload cap at the proximal end of each tower.

[0036] BRIEF DESCRIPTION OF DRAWINGS

[0037] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with the general description of the

[0038] Figure 1 is a top view of a spinal column having a lateral curve defect and having a plurality of pedicle screws implanted in the spinal column.

[0039] Figure 2 is a top view of a spinal column having a lateral curve defect and having a plurality of pedicle screws implanted in the spinal column.

[0040] Figure 3 is Figure 2 is a side view of the spinal column shown.

[0041] Figure 4 is Figure 2 is an orthogonal view of the spinal column shown.

[0042] Figure 5 shows a top view of a spinal column having a plurality of curved extensions engaged with a plurality of screws in vertebrae of the spinal column, also showing a lateral generally straight rod engaged with the plurality of curved extensions and partially advanced toward distal ends of the curved extensions.

[0043] Figure 6 shows Figure 5A side view of a spine having multiple curved extensions engaged with multiple screws in the vertebrae of the spine, and also showing a transversely generally straight rod engaged with the multiple curved extensions and partially advancing toward the distal ends of the curved extensions.

[0044] Figure 7 It shows Figure 5 An orthogonal view of the spine, showing multiple curved extensions engaged with multiple screws in the vertebrae of the spine, and also showing a transversely generally straight rod engaged with the multiple curved extensions and partially advancing toward the distal ends of the curved extensions.

[0045] Figure 8 The embodiments of any of the systems, apparatuses, and methods disclosed herein are shown for lateral adjustment of the vertebrae to a laterally aligned position. Figures 1-7 A top view of the spine.

[0046] Figure 9 It shows Figure 8 A side view of the spine.

[0047] Figure 10 A side view of several extended portions of an embodiment of a system for treating scoliosis is shown.

[0048] Figures 11A-11G An embodiment of a rod-lowering device that can be used in conjunction with any system or device disclosed herein for the treatment of the spine is shown.

[0049] Figures 12A-12G Another embodiment of the bar lowering device is shown, which can be used with any system or device disclosed herein for the treatment of the spine.

[0050] Figure 13 This is an isometric view of an embodiment of a system or part of a system for treating scoliosis.

[0051] Figure 14A This is an isometric view of an embodiment of a system or part of a system for treating scoliosis.

[0052] Figure 14B yes Figure 14A A side view of an embodiment of the system or a part of the system shown.

[0053] Figure 14C yes Figure 14A A side view of a portion of the illustrated embodiment.

[0054] Figure 15 This is an isometric view of another embodiment of a device for treating scoliosis.

[0055] Figure 16is an isometric view of another embodiment of a device for treating scoliosis.

[0056] Detailed description of some embodiments

[0057] Some embodiments of the devices and methods disclosed herein start with an optimized pre-shaped rod and bend the spine to accommodate the rod, rather than bending the rod to accommodate the spine during spinal deformation and scoliosis surgery.

[0058] In some embodiments, a system of curved or bent towers and blades attached to pedicle screws during spinal deformation and scoliosis surgery can guide a pre-bent rod into the base of the pedicle screw head. Traditional towers and reduction structures used to reduce the rod into the seat of the head of the pedicle screw are straight. If the head of the pedicle screw is polyaxial, the straight tower or reduction structure can be tilted in different directions. However, in deformity correction surgery, polyaxial screws reduce the ability to reduce spinal deformity because any correction made by exerting force on the tower or rod (rod rotation, reduction, etc.) causes the polyaxial pedicle screw head to rotate in its polyaxial joint, rather than rotating the actual vertebrae. The purpose of the polyaxial screw head is to compensate for changes in the alignment of the screw with the rod, otherwise the rod must be perfectly aligned and angled within the screw head.

[0059] By using a custom curved or bent tower or blade, a pre-bent rod with a fixed optimized final shape can be fitted within the system of curved or bent towers and slowly lowered into the seat of the screw. In this way, the head of the pedicle screw does not have to be polyaxial. The screw can be a fixed angle screw, where the screw head cannot move relative to the threaded shaft of the screw. Alternatively, the screw head can be monoaxial (monoaxial) or have limited polyaxial rotation. By limiting the degree of movement and rotation between the screw head and the screw, rotation and reduction of the rod into the vertebrae will cause rotation and reduction of the vertebral body, rather than the head of the polyaxial screw.

[0060] In another preferred embodiment, the blades or walls of the tower diverge from the distal end connected to the screw head towards the proximal end outside the body. The diverging spread of the blades or walls of the tower allows for easier "capture" of the pre-bent rod. Essentially, this opening of the blades or tower at the proximal end allows the entry area of the pre-bent rod to easily pass through all the towers of the screws. The mechanism of lowering the rod down the tower to the distal end needs to accommodate this proximal divergence in this case. For example, if the walls of the tower are too wide for the cap to contact both sides, the simple cap that unscrews the threaded track within the curved or bent tower is no longer sufficient. Instead, external tracks located on the sides or outside of the tower walls and a gear system that allows the pusher to travel down the tower using the tracks and gear system allow the push rod to travel on only one wall, rather than having to contact both walls.

[0061] In some embodiments, a curved or bent tower system can allow for a smooth transition from the initial pathological spinal curvature to the ideal final curvature, allowing for the pre-bent optimization rods to be lowered into the screw heads. Traditional techniques using straight towers require sequential correction of the deformity (Buchholz et al. 2020 Operative Neurosurgery 19(2):E157-E158 Deformation correction by use of reduction tower: 2-dimensional operative video. https: / / academic.oup.com / ons / amde / 19 / 2 / E157 / 5673648). When using traditional straight towers, the rods are sequentially captured into each pedicle screw, one at a time. Also, only one side (rod) is placed at a time. In some embodiments of the devices and / or methods for treating scoliosis disclosed herein, the towers, which can be curved or bent, are designed to bring the pre-bent rods into the seats of all pedicle screws simultaneously. The left and right rods can be lowered simultaneously without interference. By lowering both rods simultaneously, the strain load of the deformity correction is distributed between the pedicle screws on both sides, reducing the risk of pedicle fractures and screw loosening. Similarly, by lowering the rods using all towers and all screws simultaneously, the correction of deformation is shared among all screws compared to the sequential method shown in the video using straight towers.

[0062] With the use of straight towers, each screw is sequentially “captured,” and in this way, the greatest force or strain is placed at the location between the last screw captured and the next screw to be captured in the sequence. This concept is commonly seen as an adjacent horizontal phenomenon in spinal fusion surgery. It is the horizontal adjacent to the fusion that experiences the greatest strain and therefore has the highest risk of further degeneration. Therefore, once the rods have been placed into the towers and screw heads of some screws, these screws are essentially constrained or partially fused, i.e., they move together and their movement is constrained. Thus, when the next pedicle screw is captured in a sequential manner, an instantaneous increase in strain will be induced at the level of the next level in the sequence. On the other hand, by lowering the rods simultaneously, all screws can be subjected to similar strain. This is essentially load sharing, and allows the strain of deformity correction to be widely shared among all pedicle screws.

[0063] Any of the embodiments disclosed herein can include torque or pressure sensors. Such torque or pressure sensors can be located at the rod lowering position within each extension or tower. Furthermore, the rod lowering devices within each extension of any of the embodiments of the devices for treating scoliosis disclosed herein can be coordinated such that the torque or load of the rod lowering is distributed among all extensions.

[0064] By utilizing the coordinated descent of the rods within all of the extensions, which can be curved, the rods are lowered in the safest and most predictable manner. Both sides can be done simultaneously. Additionally, the coordination and automatic application of torque or pressure at each tower is a robotic process. Instead of traditional robotic arms used in spinal surgery, this robotic device can simultaneously monitor the strain experienced at the rods within each curved tower. In some embodiments, the rods within the towers experiencing lower strain are preferentially lowered relative to the rods within the towers experiencing higher strain. In this way, in some embodiments, the rods are lowered into the heads of the screws in terms of strain on the segment of vertebrae and the spinal deformity is more evenly corrected. If the strain measured by the torque or strain sensors or transducers exceeds a cutoff, the feedback system stops the entire system to prevent the risk of breaking the vertebrae or pedicles. Furthermore, if there is a sudden change in torque or tension, such as a sudden drop, this can indicate a pedicle fracture or screw breakage or pullout. Thus, such a sudden change including strain lowering would indicate a need to stop.

[0065] During rod lowering, in some embodiments, the correction of the spinal deformity can be aided by rotation of the rods or manipulation of the surgical bed, or application of force externally to the body. Rod rotation is the mainstay of traditional deformity correction. In addition to optimizing the curvature of the curved towers, controlled rod rotation using robotic mechanisms is also helpful for some embodiments of the methods and devices disclosed herein. Additionally, chiropractors and physiotherapists often use external bracing and chairs including external bracing to reduce scoliosis deformity. This external force can also be applied during surgery to aid in deformity correction. External force can be applied using inflatable airbags located on the sides of the subject as well as gears located within the bed that allow the surgical bed to bend. Mizuho OSI’s Proaxis is an example of a bed that can adjust the degree of bending and stretching with precision through touch buttons. Using a unified approach that simultaneously uses external and internal forces will aid in safely and quickly correcting deformity during surgery.

[0066] New techniques for scoliosis surgery, particularly adolescent idiopathic scoliosis and early onset scoliosis, use growing rod technology, even magnetically controlled growing rods. Some of these rod devices have internal gears and mechanics. Others have used multiple rods and larger rods to lower the risk of rod breakage and implant failure. As these newer rod devices become more complex, they also become more difficult to bend. Thus, the idea of bending the spine to accommodate the rod concept becomes more and more relevant as complex rods become difficult or impossible to bend. By utilizing the devices of some embodiments described herein and by curving or bending the towers, pre-shaped rods can be lowered into the screw heads with non-fusion growing rod devices that can grow or lengthen as the child grows, easily placed into the spine with simultaneous reduction of deformity without the need for rod bending.

[0067] The novel aspect of some embodiments disclosed herein is the curved or bent towers that are placed on the head of the pedicle screw. However, the benefits or advantages of some embodiments of the devices and methods disclosed herein extend to the system of curved or bent towers that together are used to correct the deformity in scoliosis and deformity surgery. Mathematically, the system of curved or bent towers constitutes a transformation from the abnormal 3-D geometry of the starting deformity (i.e. the deformed spine) to the final 3-D normalized spine geometry represented by the pre-bent rod with the optimized shape. Prior to the transformation taking place, the distal ends of the series of curved or bent tubes (the pedicle screw end) are configured to the abnormal geometry of the spinal deformity. At the same time, the proximal ends of the series of curved or bent tubes are configured to the final desired 3-D geometry that represents the final corrected or normalized shape of the spine. This normalized shape is represented and characterized by the pre-bent rod. As the transformation takes place, the rod descends into the series of curved towers and the abnormal spinal curvature is translated into the curvature of the pre-bent rod. Finally, when the rod is fully inserted into the screw head, the deformity is corrected and the transformation is complete.

[0068] The transformation from the abnormal deformity to the normalized spine is a geometric topological transformation in three-dimensional space. This transformation can be characterized by the function N = f(D), where D is the 3-dimensional space that includes the deformed spine and N is the 3-dimensional space that includes the normalized spine. The function f() performs the transformation that corrects the deformity. The function f() is performed by the system of curved or bent towers and the shape of the pre-bent rod. f() depends not only on the spatial coordinates but also on other factors that make the transformation safe and effective. For example, the amount of torque or force encountered at the contact point of the rod with each "pusher" within each tower can be important for sharing the load as much as possible between the towers.

[0069] The system of curves or bends of the tower necessary to implement the transformation f() and its properties can depend on many factors. Some embodiments of the tower can need to be most curved, bent or offset at the apex of the deformation. By offset is meant that when the tower or extension is in an operable position, the proximal portion of the tower or extension is at a lateral distance compared to the distal portion of the tower or extension. In the case where there is an "S" shaped deformation with multiple apexes, other towers can be slightly curved, bent or offset in the opposite direction, or straight, or curved, bent or offset. Furthermore, the transformation occurs in a continuous manner at the rod is outside the body, or over the entire length of the tower. As a theoretical exercise, one can imagine using a very long tower. In this case, the tower can be bent or curved only near the proximal end of the tower where the rod is first inserted. By passing the rod through a series of curves and bends, the spinal deformity can have been corrected when the rod is still far from the distal end and even not inside the body. The rod then passes through a straight portion of the tower to the distal end, which maintains the normalized spinal alignment. This feature can allow the correction and recalibration of the vertebral deformity without the rod being directly inside the screw head. Thus, in this way, a "corrective" rod can be used outside the body to correct the orthopedic deformity, and then, with the vertebral screw heads aligned, a "permanent" rod or device can be implanted. This "permanent" device can be a growing rod or a bendable rod that is not suitable for correcting the deformity but is able to maintain the alignment after being placed into the vertebral screw heads.

[0070] Preferably, the rod shaping and the configuration of the curved or bent tower are both computer and math guided. Also preferably, the rod shaping and the configuration of the curved or bent tower can be guided by AI and machine learning. The parameters for success in lowering the rod and correcting the spinal deformity are multifactorial and include patient parameters and hardware parameters. Patient parameters include age, height, weight, spinal curvature, severity of curvature, degree of flexibility of the curve X-rays, bone quality, congenital abnormalities (synostosis, etc.), etc. Hardware parameters can include length of extension, degree of curvature of extension, degree of bend or lateral offset of extension, distribution of curvature of extension (i.e. curvature is spread over the entire length of the extension compared to only one or a few segments of the extension), stiffness of extension, mobility of screw head (polyaxial, monoaxial or fixed screw head), stiffness of rod, diameter of rod, and / or operability of surgical table or external compression device, etc. These parameters can be guided into a computer machine learning algorithm to guide the selection of the optimal curved tube that will effectively and safely allow the pre-bent rod to be lowered into the tower until the screw head. Thus, through multiple iterations and learning, the machine learning algorithm is able to construct the N = f(D) mapping from the deformity space D to the normalization space N for the general case, i.e. for all patients and under all conditions.

[0071] Also preferably, the pedicle screws themselves can be inserted by robotic means. Robotic guidance and insertion of pedicle screws is a reality and can lead to accurate, safe and efficient placement of pedicle screws. In some embodiments, coordination between robotic placement of the screws and computer algorithms that then configure the tower will allow for the most precise and optimal correction of the vertebrae using optimally designed rods that are pre-bent. Currently, growing rods used in scoliosis surgery only grow at one location on the rod. Preferably, the rod will grow throughout the scoliosis construct, with growable segments or externally controllable growable segments located between anchor locations within the rod where the rod connects to the pedicle screws. In this way, the spinal deformity can be corrected and allowed to grow as the child grows in height.

[0072] In some embodiments, the curvature or bend of the tower can be adjustable. One simple example of a bendable tower is a mechanism similar to a folding ladder. Folding ladders have a bend pivot point that can change the degree and angle of the bend, and the pivot point is locked so that the ladder described above is stable at various heights and angles. Using a similar locking but bending mechanism, a bendable tower with a wall that is bent but then locked can be configured in situ to match the curvature of the pre-bent rod. Essentially, the tower just needs to bend so that the pre-bent rod can "fit" inside all of the tower. Once the rod is captured within the tower, the rod lowering process can lower the rod into the head of the screw. This in situ tower bending can not be optimal because the transition from the deformed spine to the standardized spinal alignment is not as smooth as a pre-planned smooth tower. However, in some cases, such as an emergency surgery where pre-planning is not possible, this in situ approach can be necessary and useful.

[0073] In other embodiments, the tower can be bendable and adjustable, and the process of bending the tower can be computer guided. The bend in the tower can be regulated and controlled by a computer, and by definition, the tower can be considered or defined as a robot. The tower can essentially be a small robotic arm. In this way, there is an infinite degree of freedom in the way the deformed spine (D) is corrected into the normalized spinal alignment (N). The robotic controlled bendable tower population is connected to the pedicle screws in the deformed spine. The proximal end is robotically bent to accept a pre-bent rod that has been bent into the final standardized and optimized shape. In this case, the transformation f() no longer includes a tower with a fixed curvature or bend. Instead, f() now includes a timeline through which the curvature or bend of the tower can be continuously adjusted as the rod is lowered distally into the screw head. The timeline of the curvature or angle in the tower can be adjusted in flight according to the resistance and torque encountered as the rod is lowered, thereby correcting the curve. This ability to automatically control the bend allows for a final degree of freedom, but also makes the transformation more complex. In this case, computer modeling and AI will be the ideal method to work out the transformation.

[0074] Some embodiments disclosed herein relate to devices (also referred to herein as systems) and methods for correcting scoliosis, as shown in the figures. In some embodiments, the devices and methods are configured for treating a scoliosis of a patient's spine. Figures 1-4 A spine S is shown having a lateral curvature defect and having a device 50 including a plurality of pedicle screws 52 coupled with extensions 54 implanted in the spine. Referring to Figures 2-4 , the device 50 can have a pair of rods 56 that are generally straight in a lateral direction in the desired position and orientation relative to the spine as shown (referred to as straight rods or lateral straight rods), but are not adapted to fit within the heads of the pedicle screws 52 as shown due to the curvature of the spine.

[0075] In other embodiments of the devices disclosed herein, including the device 100 shown in Figures 5-10 , can include a plurality of screws 102 configured to be implanted in a plurality of vertebrae and a plurality of extensions 110 (also referred to herein as guides, guide members, guide elements, or towers) configured to be detachably coupled with the plurality of screws 102 or a plurality of screw heads 104 coupled with the screws 102, as shown in Figures 5-7 . In any of the embodiments disclosed herein, including but not limited to embodiments of the device 100, one or more extensions, including but not limited to the extensions 110, can be curved, bent, angled, offset, or otherwise. In such configurations, the extensions can be configured to accommodate lateral straight rods 130 and to correct a deformity of the spine, as further described herein, resulting in the arrangement shown in Figures 8-9 .

[0076] As shown in Figures 5-7 , in some embodiments, each of the plurality of screws 102 can have a screw head 104 and each of the plurality of extensions 110 can have a proximal portion 110a, a distal portion 110b configured to be detachably coupled with the screw head 104 of each of the plurality of screws 102, and an intermediate portion 110c between the proximal portion 110a and the distal portion 110b. The plurality of extensions of any of the embodiments of the devices disclosed herein can be curved, bent, angled, or offset along at least a portion thereof, for example, along all or a portion of a middle portion of the extension, or in other embodiments, along an entire length of the extension. In some embodiments, at least one of the plurality of extensions 110 can have at least one approximately straight portion along a length of the extension.

[0077] Any of the embodiments of the devices disclosed herein can further include a rod, for example Figures 5-9The rod 130, as shown in the middle, can be configured to couple or selectively engage with the plurality of screw heads 104, where the device 100 can be configured such that the rod 130 can be directed along the plurality of extensions 110 from the proximal end portion 110a of the plurality of extensions 110 toward the distal end portion 110b of the plurality of extensions 110 and into engagement with the plurality of screws 102. In some embodiments, as shown in the middle, for example, the rod 130 can be bent and / or curved in a sagittal plane (or other non-lateral direction) into a desired configuration while still having a generally lateral straight shape, with the non-lateral curvature of the rod generally matching the desired post-operative curvature of the spine. Figure 9

[0078] In any embodiment of the devices disclosed herein, extensions 110 of different curvatures and / or lengths can be selected and coupled with screw heads 104 such that the distal end portion 110b of the extension engages with the vertebrae at the pre-operative position of the vertebrae and such that the proximal end portion 110a of the extension can be approximately or substantially aligned. For example, but not by way of limitation, the proximal end portion 110a of each extension 110 can be configured such that when the extension 110 is in an operable state, as shown in the middle, for example, the proximal end portion 110a of the extension 110 can be closely enough aligned such that a laterally straight and substantially rigid rod can engage with the proximal end portion 110a of each extension 110 or the slot 140 of each extension 110 while the distal end portion 110b of the extension follows the shape and / or position of the scoliotic spine. In such an arrangement, as the laterally straight and substantially rigid rod 130 is moved through the slot 140 of the extension 110 toward the distal end portion 110b of the extension 110, the rigidity and linear straightness of the rod 130 will cause the distal end portion 110b of the extension 110 and thus the screw 102 and the vertebrae engaged with the screw to move toward the linear centerline of the spine or to move the vertebrae into general alignment. Figures 5-7

[0079] Thus, the devices and methods of any embodiment described herein, including but not limited to embodiments of the device 100, can be configured to move one or more vertebrae in a lateral direction and into general lateral alignment as the rod 130 is advanced toward the distal end portion 110b of the plurality of extensions 110 and into engagement with the plurality of screw heads 104. Further, the devices and methods can be configured such that the rod 130 can be simultaneously advanced down the plurality of extensions 110 by incrementally advancing the rod 130 toward the distal end portion 110b of each of the plurality of extensions 110. The devices and methods of any embodiment, including but not limited to embodiments of the device 100, can be configured to move one or more vertebrae toward the lateral centerline of the spine as the rod 130 is advanced toward the distal end portion 110b of the plurality of extensions 110.

[0080] ​​In any of the embodiments disclosed herein, the rod 130 and other components of the device 100 can be made of any suitable material and can have any of the features of any conventional spinal implant device. In addition, the rod 130 can be generally straight in the transverse direction in some embodiments. As noted above, the rod 130 can be curved in the sagittal plane.

[0081] In addition, to accommodate a variety of different spinal conditions, the devices of any of the embodiments disclosed herein, including the device 100, can have a plurality of extensions 110 having different lengths and / or different curvatures, bends, or offsets. Figure 10 Embodiments of a plurality of extensions 110 that can be used with any of the embodiments of the devices disclosed herein are shown. Figure 10 A first extension 111, a second extension 112, a third extension 113, a fourth extension 114, a fifth extension 115, and a sixth extension 116 are shown. The first extension 111 can have a proximal end portion 111a, a distal end portion 111b, and a middle portion 111c extending between the proximal end portion 111a and the distal end portion 111b. The second extension 112 can have a proximal end portion 112a, a distal end portion 112b, and a middle portion 112c extending between the proximal end portion 112a and the distal end portion 112b. The third extension 113 can have a proximal end portion 113a, a distal end portion 113b, and a middle portion 113c extending between the proximal end portion 113a and the distal end portion 113b. The fourth extension 114 can have a proximal end portion 114a, a distal end portion 114b, and a middle portion 114c extending between the proximal end portion 114a and the distal end portion 114b. The fifth extension 115 can have a proximal end portion 115a, a distal end portion 115b, and a middle portion 115c extending between the proximal end portion 115a and the distal end portion 115b. The sixth extension 116 can have a proximal end portion 116a, a distal end portion 116b, and a middle portion 116c extending between the proximal end portion 116a and the distal end portion 116b. The proximal end portions of some embodiments of the first extension 111, the second extension 112, the third extension 113, the fourth extension 114, the fifth extension 115, and the sixth extension 116 can be curved, bent, angled, or otherwise offset from their distal end portions.

[0082] In any embodiment, the middle portion 111c of the first extension 111 can have a first curvature, inflection, angle, or offset; the middle portion 112c of the second extension 112 can have a second curvature, inflection, angle, or offset; and the second curvature, inflection, angle, or offset can be greater than or different from the first curvature, inflection, angle, or offset. The middle portion 113c of the third extension 113 can have a third curvature, inflection, angle, or offset, and the third curvature, inflection, angle, or offset can be greater than or different from the second curvature, inflection, angle, or offset. The middle portion 114c of the fourth extension 114 can have a fourth curvature, inflection, angle, or offset, and the fourth curvature, inflection, angle, or offset can be greater than or different from the third curvature, inflection, angle, or offset. The middle portion 115c of the fifth extension 114 can have a fifth curvature, inflection, angle, or offset, and the fifth curvature, inflection, angle, or offset can be greater than or different from the fourth curvature, inflection, angle, or offset. The sixth extension can have a generally straight profile. In some embodiments, the device can be configured such that the plurality of extensions 110 can have at least four different curvatures, inflections, angles, or offsets and / or lengths. In some embodiments, the device can have at least five different curvatures, inflections, angles, or offsets and / or lengths, or five to ten different curvatures, inflections, angles, or offsets and / or lengths.

[0083] Additionally, in any of the embodiments disclosed herein, the distal end portion 110b of the extension 110 can be straight. The distal end portion 110b of any of the extensions described herein can be axially aligned with the screw 102 and / or the screw head 104, e.g., parallel to and coaxial with the threaded screw body of the screw, and rigidly coupled or related to the screw and / or the screw head. In any of the embodiments disclosed herein, the distal end portion of at least one of the plurality of extensions, including but not limited to the extension 110, can be flexibly coupled to the respective screw and / or screw head in any of the embodiments disclosed herein. For example, but not by way of limitation, the system can be configured such that at least one of the plurality of extensions (or, in other embodiments, all of the plurality of extensions) is configured to rotate in a lateral direction (or at least in a lateral direction) relative to the respective screw to which the extension is coupled, where the lateral direction is a direction in a plane perpendicular to the spinal column centerline. For example, but not by way of limitation, the extension can be configured to rotate in the lateral direction relative to an axial centerline of the respective screw in a range of 20 degrees or about 20 degrees, or in a range of 10 degrees or about 10 degrees, where the lateral direction is a direction in a plane perpendicular to the spinal column centerline. In any embodiment, the system can be configured such that the distal end portion of each of the plurality of extensions is configured to be rigidly coupled with a respective one of the plurality of screws and / or a respective one of the plurality of screw heads, such that at least the distal end portion of each of the plurality of extensions is axially aligned with the respective screw and / or screw head and is prevented from rotating relative to each of the plurality of screws in the operable position. Further, the distal end portion 110b of the extension 110 can have a length that is greater than or equal to the length from the distal end of the extension to the surface of the patient's skin, such that the distal end portion 110b of each of the plurality of extensions 110 extends at least to the surface of the patient's skin. In such a configuration, the portion of the extension 110 within the patient's body can be straight, and such that any curvature, bend, angle, or offset of the extension occurs outside of the patient's body. Further, in any of the embodiments disclosed herein, the proximal portion and / or the distal portion can be curved, bent, angled, or otherwise offset.

[0084] Additionally, any embodiment of the extension 110 can have a discontinuous curve along its length. For example, a proximal portion of the extension 110 can be curved, an adjacent portion generally straight, followed by another curved segment adjacent to or in a distal portion. Further, any embodiment can have multiple bends along the length of the extension, or multiple bends separated by straight portions and / or multiple angled regions along the length of the extension, or a combination of curves, bends, and / or angles along its length. Further, any embodiment of the extension 110 can be curved in multiple directions. For example, but not limited to, any embodiment of the extension can be curved in one direction in a first portion of the extension, and then curved in another direction (e.g., opposite direction) in a second portion of the extension. Any embodiment can be curved in an "S" shape.

[0085] In some embodiments, each of the plurality of extensions 110 can have a slot 140 extending therein from a proximal portion 110a of each of the plurality of extensions 110 toward a distal portion 110b of each of the plurality of extensions 110, where the slot 140 of each of the plurality of extensions 110 can be configured to slidably house the rod 130 therein, such that the rod 130 can be guided toward the plurality of screw heads 104 using the slots 140 of the plurality of extensions 110. For example, Figures 5-7 A rod 130 is shown being advanced down the slots 140 of the plurality of extensions 110 toward the distal portions 110b of the extensions 110. Similar arrangements can be used to advance the rod 130 down the slots 140 of the plurality of extensions 110 toward the distal portions 110b of the extensions 110. Figures 5-7 A second set of screws 102 is shown being slid down the slots 140 of the plurality of extensions 110 (the extensions 110 of the second set of screws 102 are omitted for clarity). The first and second rods 130 can be advanced generally simultaneously or incrementally to reduce the load on any of the screws 102 and extensions 110.

[0086] In some embodiments, the device 100 can have a plurality of pushing elements or inserts (not shown) configured to couple with the plurality of extensions 110 and selectively move the rods 130 downward toward the distal portions 110b of the plurality of extensions 110 toward the plurality of screw heads 104 when the plurality of pushing elements are advanced toward the distal portions 110b of the plurality of extensions 110. The pushing elements are one non-limiting example of a mechanism and method for incrementally advancing the rods 130 toward the distal portions 110b of the plurality of extensions 110. The pushing elements or inserts can be configured to move downward along the slots 140 or openings formed in the extensions 110 or can be configured to move downward along the outer surfaces of the extensions 110 to move the rods 130 toward the distal portions 110b of the extensions 110. Thus, the pushing elements can couple or engage with the rods 130 and the extensions 110 to allow a surgeon or automated machine (such as, but not limited to, a surgical robot) to selectively and incrementally (and independently) advance the rods 130 toward each of the distal portions 110b of the extensions 110. In any embodiment, the pushing elements can be selectively movable in a proximal direction toward the proximal portions 110a of the extensions 110 to allow the rods 130 to move proximally for readjustment or otherwise of the rods 130. Flexible shaft tools can be used to push or rotate the pushing elements toward the distal portions 110b of the extensions 110.

[0087] In some embodiments, the plurality of pushing elements and / or other components of the device for advancing the rods 130 can each be selectively biased to prevent movement toward the proximal portions 110a of the plurality of extensions 110 as the plurality of pushing elements or other components are advanced toward the distal portions 110b of the plurality of extensions 110. In some embodiments, the device 100 can have a plurality of threaded pushing elements configured to threadably engage with the plurality of extensions 110 and selectively move the rods 130 downward toward the distal portions 110b of the plurality of extensions 110 toward the plurality of screw heads 104 as the plurality of pushing elements are threadably advanced toward the distal portions 110b of the plurality of extensions 110. In any embodiment, the plurality of threaded pushing elements can be the plurality of screws 102.

[0088] In some embodiments, the plurality of extensions 110 can have a slot 140 extending therefrom toward the distal end portion 110b of each of the plurality of extensions 110 from the proximal end portion 110a of each of the plurality of extensions 110. The slot 140 can extend all the way to the screw head 104 of each of the plurality of screws 102, which is adjacent to the distal end portion 110b of the extension 110. The slot 140 of each of the plurality of extensions 110 can be configured to slidably house the rod 130 therein, such that the rod 130 can be guided toward the plurality of screw heads 104 with the slot 140 of the plurality of extensions 110. A plurality of pushing elements can be configured to engage with the slot 140 of each of the plurality of extensions 110. For example, but not limited to, the slot 140 of each of the plurality of extensions 110 can have an internal threading therein configured to threadably engage with a plurality of threaded pushing elements, which can be threadably advanced in the slot 140 toward the distal end portion 110b of the plurality of extensions 110 to advance the rod 130 toward the plurality of screw heads 104.

[0089] In any embodiment, the device 100 can be configured to selectively prevent the rod 130 from moving toward the proximal end portion 110a of each of the plurality of extensions 110 as the rod 130 is advanced toward the distal end portion 110b of each of the plurality of extensions 110. In some embodiments, a plurality of guide elements can be configured to couple with the rod 130 and slide along the plurality of extensions 110 from the proximal end portion 110a of each of the plurality of extensions 110 toward the distal end portion 110b of each of the plurality of extensions 110 to guide the rod 130 toward the plurality of screw heads 104. In any embodiment, the device can also have a plurality of locking caps or other suitable components or features, each configured to engage with the screw head of each of the plurality of screws 102 and secure the rod 130 to each screw head 104.

[0090] In some embodiments, with reference to Figure 7 , the plurality of screws 102 can include a first plurality of screws 102 and a second plurality of screws 102. Any embodiment of the device 100 can be configured such that the first plurality of screws 102 are each implanted in a plurality of vertebrae adjacent to each of the second plurality of screws 102. For example, the first plurality of screws 102 can be located on one side of a vertebra and the second plurality of screws 102 can be located on a second side of the vertebra.

[0091] The plurality of extensions 110 can include a first plurality of extensions 110 and a second plurality of extensions 110, where each of the first plurality of extensions 110 can be configured to be detachably coupled with a screw head of each of the first plurality of screws 102 on a first side of a vertebra, and each of the second plurality of extensions 110 can be configured to be detachably coupled with a screw head of each of the second plurality of screws 102 on a second side of the vertebra.

[0092] Additionally, the device of any of the embodiments disclosed herein (including but not limited to the device 100) can have a first rod 130 and a second rod 130, and the device can be configured such that the first rod 130 can be guided along the first plurality of extensions 110 from a proximal end portion 110a of the first plurality of extensions 110 toward a distal end portion 110b of the first plurality of extensions 110 and engaged with the first plurality of screws 102, and such that the second rod 130 can be guided along the second plurality of extensions 110 from a proximal end portion 110a of the second plurality of extensions 110 toward a distal end portion 110b of the second plurality of extensions 110 and engaged with the second plurality of screws 102.

[0093] Additionally, the device of any of the embodiments disclosed herein (including but not limited to the device 100) can have a first screw having a first screw head, a second screw having a second screw head, and a third screw having a third screw head, each of which can be implanted in a vertebra of a patient or subject. The device of any of the embodiments disclosed herein can also have a first extension having a proximal end portion 110a, a distal end portion 110b configured to be detachably coupled with the first screw head, and an intermediate portion 110c between the proximal end portion 110b and the distal end portion 110b, where at least a portion of the first extension can be curved. Some embodiments of the device can also have a second extension having a proximal end portion 110a, a distal end portion 110b configured to be detachably coupled with the second screw head, and an intermediate portion 110c between the proximal end portion 110b and the distal end portion 110b, where at least a portion of the second extension can be curved. Some embodiments of the device can also have a third extension having a proximal end portion 110a, a distal end portion 110b configured to be detachably coupled with the third screw head, and an intermediate portion 110c between the proximal end portion 110b and the distal end portion 110b, where at least a portion of the third extension can be curved.

[0094] Figures 11A-11G and Figures 12A-12G Embodiments of a straight rod reduction device 200 and a curved rod reduction device 300 are shown, respectively, which can be used with any of the systems or devices disclosed herein to treat a spinal column. Thus, in any embodiment, the rod reduction device 200, 300 can be straight (as shown in FIGS. 2A and 2B) or curved (as shown in FIGS. 3A and 3B).Figures 11A-11G straight (as shown), curved (as shown), bent, offset, or otherwise not straight. Figures 12A-12G straight (as shown), curved (as shown), bent, offset, or otherwise not straight.

[0095] In some embodiments of the systems disclosed herein, one of the rod lowering devices 200, 300 will be positioned on each extension or multiple extensions of any of the systems disclosed herein. The rod lowering devices 200, 300 can be configured to advance over a track, channel, groove, or other feature located on the outer surface of the extension, including straight, angled, and / or curved extensions. Additionally, the rod lowering devices 200, 300 can be configured to work with a surgical robotic arm or an end effector connected thereto, such that all or multiple rod lowering devices 200, 300 can be used simultaneously to lower the rod drag screw heads. In such a configuration, the process of rod lowering can be a coordinated effort directed and programmed by a computer. Additionally, in any embodiment, the rod lowering devices 200, 300 can have, for example but not limited to, a torque or force sensor on the contact member 210, 310 to provide feedback regarding the amount of force applied to the contact member 210, 310, and thus the amount of force applied to the rod. This can be used to prevent excessive torque or pressure at any portion of the rod. A goal of some embodiments is to push the rod down with as uniform a torque as possible, distributed among all the towers.

[0096] Some embodiments of the systems disclosed herein can include multiple rod lowering devices 200, 300 to assist in lowering the rod toward multiple screw heads and to move one or more vertebrae in a lateral direction as the rod is lowered downward toward the distal ends of the multiple rod lowering devices. In some embodiments, each of the rod lowering devices 200, 300 can include a body portion 202, 302 having a channel 204, 304 therethrough configured to accommodate a respective one of a plurality of extensions, including but not limited to extensions 110, 111-116, etc., therein as the rod lowering device 200, 300 passes over the plurality of extensions, and a contact member 210, 310 configured to translate along the length of the body portion 202, 302 of the rod lowering device 200, 300. The contact member 210, 310 can be configured to detachably couple with a rod configured to couple with the plurality of screw heads, such as but not limited to rod 56, rod 130, etc. In some embodiments, each of the body portions 202, 302 can have a distal end portion 202a, 302a configured to detachably couple with a respective one of the screw, a respective one of the screw heads, and / or a distal end portion of a respective one of the extensions.

[0097] Further, in some embodiments, the rod lowering device 200, 300 can be configured to move the rod toward the screw head as the contact member 210, 310 is moved toward the screw head. In other words, in some embodiments, the contact member 210, 310 can be configured to be coupled with the rod such that as the contact member 210, 310 is moved toward the distal end 202a, 302a of the body portion 202, 302 of the rod lowering device 200, 300, the rod will simultaneously be moved toward the distal end 202a, 302a of the body portion 202, 302 of the rod lowering device 200, 300. The contact member 210, 310 can be configured to slide, roll, or translate along the body portion 202, 302. The contact member 210, 310 can have one or more pins or protrusions 216, 316 that can be grasped or otherwise contacted to move the contact member 210, 310. For example, and without limitation, a robotic arm or a component affixed to a robotic arm can be coupled with the one or more protrusions 216 such that movement of the plurality of contact members 202, 302 can be controlled by the one or more robotic arms.

[0098] In some embodiments, the body portion 202, 302 of the one or more rod lowering devices 200, 300 can have one or more grooves 220, 320 along its length, where each of the grooves 220, 320 is configured to accommodate a portion of the contact member 210, 310 therein as the contact member 210, 310 is advanced along the length of the body portion 202, 302 of the respective rod lowering device 200, 300. The grooves 220, 320 can be configured to accommodate the protrusion or wheel 222, 322 of the contact member 210, 310 therein as the contact member 210, 310 is advanced along the length of the body portion 202, 302 of the respective rod lowering device 200, 300.

[0099] In any of the embodiments disclosed herein, the channel 204, 304 can be threaded along its length, and the rod lowering device 200, 300 can have a threaded cap 230, 330 configured to be threaded down the channel 204, 304 toward the screw head. The cap 230, 330 can be configured to threadably couple with each of the plurality of screw heads to secure the rod to the plurality of screw heads.

[0100] Figure 13 is an isometric view of an embodiment of a system 400 for treating a scoliosis or a portion thereof. Figures 14A-14CAnother embodiment of a system 400 or a portion thereof for treating scoliosis is shown. System 400 may include a plurality of screws 402, a plurality of screw heads 404 coupled to the plurality of screws 402, and a plurality of extensions 406 detachably coupled to the plurality of screws 402 and / or the plurality of screw heads 404. Extensions 406 (also referred to herein as towers or short towers) may have openings 410 therein, which may be in the proximal portion of the extension 406. In any embodiment, system 400 may include a first guide member 420, a second guide member 422, a third guide member 424, a fourth guide member 426, a fifth guide member 428, and / or a sixth guide member 430. In some embodiments, guide members 420-430 may be generally rigid and configured to transmit shear forces along their length to the extensions when the guide members are laterally displaced, so as to laterally move or displace the corresponding vertebrae when the guide members are laterally displaced.

[0101] Any of the guide members 420-430 may have a straight trajectory (e.g., as in the first guide member 420), a curved trajectory (e.g., as in the second to sixth guide members 422-430), a zigzag trajectory, or an otherwise offset trajectory, wherein the distal portion of the guide member (i.e., the end closest to extension 406) is in a different lateral position compared to the proximal portion of the guide member when the guide member and other components of the system are in an operable position within the patient's body. Other embodiments may have any desired number of each of the guide members 420-430, or guide members with other trajectories.

[0102] The guide members 420-430 may be coupled to the proximal portion of the extension 406. For example, but not limited to, such as Figure 13 As shown, guide members 420-430 can be coupled to or advanced into the opening 410 of the extension 406. In other embodiments, such as Figures 14A-14C As shown, guide members 420-430 may be coupled to the proximal end of extension 406 at a location laterally offset from the opening 410 of each guide member 420-430. In this configuration, the opening 410 of each extension 406 will not be covered by the guide members 420-430, thereby allowing a tool to pass through the opening 410 to engage a cap 460, which may be pre-loaded in each extension 406 to rotate toward and thread-protrude the cap 460 towards the screw head 404. In any embodiment disclosed herein, any guide member 420-430 may be solid, hollow (e.g., tubular), or other shapes, and may have any desired cross-sectional shape, including circular, non-circular, square, oval, polygonal, or other shapes.

[0103] In any of the embodiments disclosed herein, the system 400 can be configured such that the guide members 420-430 are positioned entirely outside of the patient's body, or above the skin level of the patient's body, when the screws 402 are implanted in operable positions in the patient's spinal column. The guide members 420-430 can be configured to guide an external rod or alignment element (not shown) toward the distal end of the guide members 420-430. The alignment element can be configured such that the screws 402 and the vertebrae in which the screws 402 are implanted move toward a transverse centerline of the patient's spinal column as the alignment element is advanced toward the distal end of the guide members 420-430, thereby moving the respective vertebrae into generally transverse alignment or at least closer to transverse alignment. The alignment element or external rod can be generally straight in the transverse direction, but have a curvature in the sagittal plane that generally matches the curvature of the patient's spinal column in the sagittal plane. The guide members 420-430 can be configured to facilitate downward movement or translation of the alignment element to the proximal end of the extensions 406, which can be shortened towers. The external rod can be positioned adjacent to the outer surface of the patient's skin, thereby avoiding the need for a full-length incision in the patient's back.

[0104] In any of the embodiments disclosed herein, the sixth guide member 430 can have a greater curvature, bend, or offset than the fifth guide element 428. The fifth guide member 428 can have a greater curvature, bend, or offset than the fourth guide element 426. The fourth guide member 426 can have a greater curvature, bend, or offset than the third guide element 424. The third guide member 424 can have a greater curvature, bend, or offset than the second guide element 422. The second guide member 422 can have a greater curvature, bend, or offset than the first guide element 420. In any of the embodiments disclosed herein, the first guide element 420 can be straight.

[0105] After the extensions 406 are aligned by the alignment element as described above, a final rod (not shown) can be advanced into all of the extensions 406. The final rod can be generally straight in the transverse direction, but have a curvature in the sagittal plane that generally matches the curvature of the patient's spinal column in the sagittal plane. The final rod can be inserted in a standard manner from the sides of the extensions, rather than from the top of the extensions, such as through each opening or slot 440 of each extension 406. For example, but not by way of limitation, the final rod can be inserted from the top of the construct or from the bottom of the construct. In this manner, the leading end of the final rod will pass consecutively through each extension 406. The final rod can then be advanced toward the screw heads 404 of each screw 402. This can avoid the need for a full-length incision in the patient's back, and instead use only a puncture incision at each extension portion 406. By generally aligning the extensions 406 with the external rod, the final rod can be more easily advanced into all of the extensions 406 and screw heads 404 in some embodiments. Thereafter, caps 460 (as described above) can be placed over the screw heads 404 and the final rod can be secured to the screw heads 404. Figures 14A-14CThe extension 406 can be advanced downward along each extension 406 and into engagement with the screw head 404.

[0106] Figure 15 is an isometric view of another embodiment of a device 500 for treating scoliosis. Any embodiment of the device 500 can be used with any embodiment of any system and / or method disclosed herein. Moreover, any embodiment of the device 500 can have any feature, component, or other detail of any embodiment of the device 500 disclosed herein, in addition to, or in combination with, any feature, component, or other detail of any embodiment of the device 500 disclosed herein, for treating scoliosis. Similarly, any other embodiment of a device, system, or method for treating scoliosis disclosed herein can have any feature, component, or other detail of any embodiment of the device 500 disclosed herein, in the place of, or in combination with, any feature, component, or other detail thereof.

[0107] Referring to Figure 15 , the device 500 can have a screw 502, a screw head 504, and an extension 506, which can have a first guide 512 and a second guide 514. In this embodiment, the first guide 512 and the second guide 514 can be offset outward from a centerline axis of the device 500. For example, and without limitation, some embodiments of the device can have a first guide 512 that curves outward and a second guide 514 that curves outward from a centerline axis of the device 500, or a first guide 512 that bends outward and a second guide 514 that bends outward from a centerline axis of the device 500, or a first guide 512 that deflects outward and a second guide 514 that deflects outward from a centerline axis of the device 500. In any embodiment, the first guide 512 can have a proximal portion 512a that is more offset from the centerline axis of the device than a distal portion 512b of the first guide 512. Similarly, the second guide 514 can have a proximal portion 514a that is more offset from the centerline axis of the device than a distal portion 514b of the second guide 514.

[0108] Because the proximal end of the extension 506 has a wide opening therein, it is easier to capture the rod in the case of a deformity curve. As the rod (not shown) is lowered, the inner surfaces of the first and second guides 512, 514 will force the rod into the seat of the pedicle screw that is coupled with the extension 506. Moreover, any embodiment of the guides 512, 514 can have an opening 516 formed therein along the entire length of the guides 512, 514 for advancing the guides 512, 514 over a guidewire 520 that can be coupled with the screw 502 or the screw head 504.

[0109] In some embodiments, the extension 506 can be closed at the top. For example, but not by way of limitation, as shown in FIG. 5A, the extension 506 can be closed at the top by a cap 508. In some embodiments, the cap 508 can be configured to be removably coupled to the extension 506, or can be configured to be non-removably coupled to the extension 506. In some embodiments, the cap 508 can be configured to be removably coupled to the extension 506 by a threaded connection, a snap-fit connection, a friction fit, a press fit, a bayonet connection, a hook and loop connection, a magnetic connection, and / or the like. In some embodiments, the cap 508 can be configured to be non-removably coupled to the extension 506 by a threaded connection, a snap-fit connection, a friction fit, a press fit, a bayonet connection, a hook and loop connection, a magnetic connection, and / or the like. Figure 16 As shown in FIG. 5B, embodiments of the device 500 can have a proximal connector 530 configured to couple the proximal ends of the guides 512, 514 together to increase the overall rigidity of the first and second guides 512, 514 and the extension 506. In some embodiments, the connector 530 can be removably coupled to the proximal portions of the guides 512, 514, or can be non-removably coupled to the proximal portions of the guides 512, 514. A rod can be passed through the space 532 between the first and second guides 512, 514, either below the connector 530 or before the connector 530 has been coupled to the guides 512, 514.

[0110] Any embodiment of the system disclosed herein can have a plurality of devices 500, where the plurality of devices 500 have different curvatures of the first and second guides, or different widths between the proximal portions of the first and second guides, to accommodate spinal columns having different levels of lateral deformation. For example, but not by way of limitation, any embodiment of the system can include: a first extension having a first width between the proximal portions of the first and second sides of the first extension; a second extension having a second width between the proximal portions of the first and second sides of the second extension; a third extension having a third width between the proximal portions of the first and second sides of the third extension; a fourth extension having a fourth width between the proximal portions of the first and second sides of the fourth extension; a fifth extension having a fifth width between the proximal portions of the first and second sides of the fifth extension, and / or a sixth extension having a sixth width between the proximal portions of the first and second sides of the sixth extension. The sixth width can be greater than the fifth width, the fifth width can be greater than the fourth width, the fourth width can be greater than the third width, the third width can be greater than the second width, and / or the second width can be greater than the first width.

[0111] The first and / or second guides of any of the first, second, third, fourth, fifth, sixth extensions of the system and / or other extensions of the system can have a straight trajectory, a curved trajectory, a bent trajectory, or otherwise offset trajectory, where the distal portion of the guide (i.e., the end closest to the screw head) is in a more narrow lateral position compared to the proximal portion of the guide when the extensions and other components of the system are in an operable position within a patient.

[0112] While certain embodiments of systems, devices, and methods for treating scoliosis have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the disclosure. Indeed, the novel methods, devices, and systems described herein can be embodied in a variety of other forms. Furthermore, various omissions, substitutions and changes in the form of the systems and methods described herein can be made without departing from the spirit of the disclosure. The accompanying claims and their equivalents are intended to cover such forms or modifications as would fall within the scope and spirit of the disclosure. The scope of the application is to be

[0113] Features, materials, characteristics or groups described in conjunction with a particular aspect, embodiment, or example are to be understood to be applicable to any other aspect, embodiment or example described in this section or elsewhere in this specification unless incompatible therewith. All of the disclosed features and / or all of the steps of any of the disclosed methods or processes can be combined in any combination, except combinations where at least some of such features and / or steps are mutually exclusive. Protection is not sought for any of the above examples in their individual details. Protection is sought for any novel one or any novel combination of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or for any novel one or any novel combination of the steps of any of the disclosed methods or processes.

[0114] Furthermore, certain features described in the context of separate embodiments in this disclosure can also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment can also be implemented in separate embodiments or in any suitable sub-combination. Moreover, although features can be described above as acting in certain combinations and / or initially conceived to be used in certain combinations, in some cases one or more features from a combination can be omitted from the combination, and the combination can be claimed as a sub-combination or variation of a sub-combination.

[0115] Moreover, while operations can be described as being performed in a certain order in the diagrams and in the description, such operations need not be performed in the order shown or in sequential order, or that all operations be performed, to achieve desirable results. Other operations that are not depicted, or that are depicted in the diagrams or description can be incorporated. For example, one or more additional operations can be performed before, after, simultaneously with, or between any of the operations described. Further, in other implementations, operations can be rearranged or reordered. Those skilled in the art will appreciate that the actual steps taken in the processes illustrated and / or disclosed can differ from those shown in the figures. Depending on the embodiment, certain of the steps described above can be removed, others can be added, and the sequence of steps can be altered. Moreover, certain features and attributes of the specific embodiments disclosed above can be combined in different manners to produce additional embodiments falling within the scope of the disclosure. Further, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated in a single product or packaged into multiple products.

[0116] For purposes of the present disclosure, certain aspects, advantages, and novel features are described herein. Not necessarily all such advantages can be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the disclosure can be embodied or carried out in a manner that achieves one advantage or group of advantages as taught herein without necessarily achieving other advantages as can be taught or suggested herein.

[0117] Conditional language, such as "can," "could," "might," or "may," unless specifically stated otherwise, generally are intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and / or steps. Thus, such conditional language generally is not intended to imply that features, elements, and / or steps are in any way required in one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, and / or steps are included or are to be performed in any particular embodiment.

[0118] Conjunctive language such as the phrase "at least one of X, Y, and Z," is not used in the conjunctive sense, but in the disjunctive sense unless otherwise stated. That is, a set of elements X, Y, and Z includes any one of X, Y, and Z individually, and any combination thereof. Thus, for example, the phrase "at least one of X, Y, and Z" is interpreted as meaning X alone, Y alone, Z alone, or any combination of X, Y, and Z.

[0119] As used herein, the language "about," "approximately," "around," and "substantially" as used herein with reference to a stated value, amount or characteristic, means a value, amount or characteristic that is close to the stated value, amount or characteristic, that still performs a desired function or achieves a desired result. For example, the terms "about," "approximately," "around," and "substantially" can refer to an amount that is within less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated amount. As another example, in certain embodiments, the terms "approximately parallel" and "substantially parallel" refer to a value, amount or characteristic that deviates from exact parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degrees.

[0120] The scope of the disclosure is not intended to be limited to the specific embodiments of the preferred implementation set forth in this section or elsewhere in this specification and can be defined by the claims or future claims presented by this section or elsewhere in this specification. The language of the claims will be interpreted broadly based on the language employed in the claims and not limited to the examples set forth in this application during prosecution of the application, which will be interpreted as non-exclusive.

Claims

1. A system for treating scoliosis, comprising: Multiple screws, each configured to be implanted into a corresponding one of multiple vertebrae, each of the multiple screws having a screw head; A plurality of rigid extensions, each configured to be detachably coupled to a corresponding one of the plurality of screws, each of the plurality of rigid extensions having a proximal portion, a distal portion configured to be detachably coupled to the screw head of the corresponding screw, and an intermediate portion between the proximal portion and the distal portion; and A rod configured to couple with the plurality of screw heads; in: The angle of the axial centerline of the proximal portion of at least one of the plurality of rigid extensions is different from the angle of the axial centerline of the distal portion of at least one of the plurality of rigid extensions. The plurality of rigid extensions include: A first rigid extension, configured to be detachably coupled to a first screw configured to be implanted into a first vertebra, wherein the first rigid extension includes: A first length extending between the proximal and distal ends of the first rigid extension; and A first curvature between the proximal and distal ends of the first rigid extension, wherein the axial centerline of the proximal portion of the first rigid extension forms a first angle with respect to the axial centerline of the distal portion of the first rigid extension, wherein the first angle is greater than zero; and A second rigid extension, configured to be detachably coupled to a second screw configured to be implanted into a second vertebra different from the first vertebra, wherein the second rigid extension includes: A second length extending between the proximal and distal ends of the second rigid extension, wherein the second length is different from the first length; and A second curvature between the proximal and distal ends of the second rigid extension, wherein the axial centerline of the proximal portion of the second rigid extension forms a second angle with respect to the axial centerline of the distal portion of the second rigid extension, wherein the second angle is greater than the first angle. The system is configured such that the rod can be guided along the plurality of rigid extensions from the proximal end of the plurality of rigid extensions toward the distal end portion of the plurality of rigid extensions and engage with the plurality of screws.

2. The system of claim 1, wherein at least the middle portion of the plurality of rigid extensions is curved along the entire length of the middle portion.

3. The system of claim 1, wherein at least the middle portion of the plurality of rigid extensions is bent along a length less than the entire length of the middle portion.

4. The system according to claim 1, wherein the axial centerline of the proximal portion of at least two of the plurality of rigid extensions is at a different angle from the axial centerline of the distal portion of the at least two of the plurality of rigid extensions.

5. The system of claim 1, comprising a third rigid extension, wherein the axial centerline of the proximal portion of the third rigid extension forms a third angle with respect to the axial centerline of the distal portion of the third rigid extension, wherein the third angle is greater than the second angle.

6. The system of claim 5, further comprising a fourth rigid extension and a fifth rigid extension, wherein: The axial centerline of the proximal end of the fourth rigid extension forms a fourth angle with respect to the axial centerline of the distal end of the fourth rigid extension. The fourth angle is greater than the third angle; The axial centerline of the proximal end of the fifth rigid extension forms a fifth angle with respect to the axial centerline of the distal end of the fifth rigid extension; and The fifth angle is greater than the fourth angle.

7. The system of claim 6, further comprising a sixth rigid extension, wherein the axial centerline of the proximal portion of the sixth rigid extension is collinear with the axial centerline of the distal portion of the sixth rigid extension.

8. The system of claim 1, wherein the system is configured to move one or more vertebrae in a lateral direction as the rod is advanced toward the distal portion of the plurality of rigid extensions and engages with the plurality of screw heads.

9. The system of claim 1, wherein the system is configured to move one or more vertebrae toward the transverse centerline of the spine when the rod is advanced toward the distal portion of the plurality of rigid extensions.

10. The system of claim 1, wherein the system is configured such that the rod can be simultaneously advanced downward along the plurality of rigid extensions by incrementally advancing the rod toward the distal portion of each of the plurality of rigid extensions.

11. The system of claim 1, wherein the rod is substantially straight in at least one lateral direction.

12. The system of claim 1, wherein each of the plurality of rigid extensions has a groove extending from a proximal portion toward a distal portion of each of the plurality of rigid extensions, wherein the groove of each of the plurality of rigid extensions is configured to slidably receive the rod therein. This allows the rod to be guided toward the plurality of screw heads through the slots in the plurality of rigid extensions.

13. The system of claim 12, further comprising a plurality of actuating elements configured to advance along the groove between the proximal and distal portions of each of the plurality of rigid extensions.

14. The system of claim 12, wherein the groove of each of the plurality of rigid extensions has an internal thread therein, the internal thread being configured to thread-engage with a plurality of thread-actuating elements capable of being thread-advanced in the groove toward the distal portion of the plurality of rigid extensions to advance the rod toward the plurality of screw heads.

15. The system of claim 1, further comprising a plurality of actuating elements configured to couple with the plurality of rigid extensions, and selectively moving the rod downward toward the distal portions of the plurality of rigid extensions toward the plurality of screw heads as the plurality of actuating elements advance toward the distal portions of the plurality of rigid extensions.

16. The system of claim 15, wherein each of the plurality of actuating elements is selectively biased to prevent movement toward the proximal portion of the plurality of rigid extensions as the plurality of actuating elements are advanced toward the distal portion of the plurality of rigid extensions.

17. The system of claim 1, further comprising a plurality of threaded screws configured to thread engage with the plurality of rigid extensions, and selectively moving the rod downward toward the distal portions of the plurality of rigid extensions toward the screw heads as the plurality of screws are threadedly advanced toward the distal portions of the plurality of rigid extensions.

18. The system of claim 1, wherein the system is configured to prevent the rod from moving toward the proximal portion of each of the plurality of rigid extensions when the rod is advanced toward the distal portion of each of the plurality of rigid extensions.

19. The system of claim 1, further comprising a plurality of guide elements configured to couple with the rod and slide along the plurality of rigid extensions from a proximal portion of each of the plurality of rigid extensions toward a distal portion of each of the plurality of rigid extensions to guide the rod toward the plurality of screw heads.

20. The system of claim 1, wherein at least one of the plurality of rigid extensions is a portion that is substantially straight along the extension length.

21. The system according to claim 1, wherein: The plurality of screws includes a first plurality of screws and a second plurality of screws; The system is configured such that each of the first plurality of screws will be implanted into a plurality of vertebrae bilaterally adjacent to each of the second plurality of screws; The plurality of rigid extensions includes a first plurality of rigid extensions and a second plurality of rigid extensions; Each of the first plurality of rigid extensions is configured to be detachably coupled to the screw head of each of the first plurality of screw heads; Each of the second plurality of rigid extensions is configured to be detachably coupled to the screw head of each of the second plurality of screw heads; The rod is a first rod, and the system includes a second rod; and The system is configured such that the first rod can be guided along the first plurality of rigid extensions from the proximal portion of the first plurality of rigid extensions toward the distal portion of the first plurality of rigid extensions and engage with the first plurality of screws, and that the second rod can be guided along the second plurality of rigid extensions from the proximal portion of the second plurality of rigid extensions toward the distal portion of the second plurality of rigid extensions and engage with the second plurality of screws.

22. The system of claim 1, comprising: A first screw having a first screw head; A second screw with a second screw head; A third screw with a third screw head; A first rigid extension has a proximal portion, a distal portion configured to be detachably coupled to the first screw head, and a body portion located between the proximal portion and the distal portion, wherein at least a portion of the first rigid extension is curved. A second rigid extension has a proximal portion, a distal portion configured to be detachably coupled to the second screw head, and a body portion located between the proximal portion and the distal portion, wherein at least a portion of the second rigid extension is curved. and A third rigid extension has a proximal portion, a distal portion configured to be detachably coupled to the third screw head, and a body portion located between the proximal portion and the distal portion, wherein at least a portion of the third rigid extension is curved.

23. The system according to claim 22, wherein: The main body of the first rigid extension has a first curvature; The main body of the second rigid extension has a second curvature; and The second curvature is different from the first curvature.

24. The system according to claim 23, wherein: The main body of the second rigid extension has a second curvature; The main body of the third rigid extension has a third curvature; and The third curvature is different from the second curvature.

25. The system of claim 1, wherein the plurality of rigid extensions have at least four different curvatures and / or lengths.

26. The system of claim 1, further comprising a plurality of locking caps, each locking cap configured to engage with the screw head of each of the plurality of screws.

27. The system of claim 1, further comprising a plurality of torque or pressure sensors, each of which is coupled to the plurality of rigid extensions and configured to operable to measure strain at the plurality of rigid extensions.

28. Systems for treating scoliosis, including: Multiple screws, each configured to be implanted into a corresponding one of multiple vertebrae, each of the multiple screws having a screw head; and A plurality of rigid extensions, each configured to be detachably coupled to a corresponding one of the plurality of screws, each of the plurality of rigid extensions having a proximal portion, a distal portion configured to be detachably coupled to the screw head of the corresponding screw, and an intermediate portion between the proximal portion and the distal portion; The plurality of rigid extensions include: A first rigid extension, comprising: A first length extending between the proximal and distal ends of the first rigid extension; and A first curvature between the proximal and distal ends of the first rigid extension, wherein when the first rigid extension is coupled to the first vertebra in an operable position, the proximal portion of the first rigid extension is laterally spaced apart from the distal portion of the first rigid extension by a first distance. A second rigid extension, the second rigid extension comprising: a second length extending between a proximal end and a distal end of the second rigid extension, wherein the second length is different from the first length; and A second curvature between the proximal and distal ends of the second rigid extension, wherein when the second rigid extension is coupled to the second vertebra in the operable position, the proximal portion of the second rigid extension is laterally spaced apart from the distal portion of the second rigid extension by a second distance. The second distance is greater than the first distance.

29. The system of claim 28, wherein the proximal portion of the third rigid extension of the plurality of rigid extensions is laterally spaced from the distal portion of the third rigid extension by a third distance when the third rigid extension is coupled to the third vertebra in an operable position, and the third distance is greater than the second distance.

30. The system of claim 28, wherein two or more of the plurality of rigid extensions are nonlinear between their proximal and distal portions.

31. The system of claim 28, wherein two or more of the plurality of rigid extensions are curved along the entire length of the intermediate portion between their proximal and distal portions or are bent along a length less than the intermediate portion.

32. The system of claim 28, wherein at least one of the plurality of rigid extensions is configured to rotate in a lateral direction relative to the corresponding screw coupled to the rigid extension within a range of 20 degrees, wherein the lateral direction is a direction in a plane perpendicular to the centerline of the spine.

33. The system of claim 28, wherein at least one of the plurality of rigid extensions is configured to rotate in a lateral direction relative to the corresponding screw coupled to the rigid extension within a range of 10 degrees, wherein the lateral direction is a direction in a plane perpendicular to the centerline of the spine.

34. The system of claim 28, wherein the distal portion of at least one of the plurality of rigid extensions is flexibly coupled to the corresponding screw and / or screw head such that the rigid extension is rotatable in a lateral direction relative to the corresponding screw within a range of 20 degrees, wherein the lateral direction is a direction in a plane perpendicular to the centerline of the spine.

35. The system of claim 28, wherein the distal portion of at least one of the plurality of rigid extensions is flexibly coupled to the corresponding screw and / or screw head such that the rigid extension is rotatable in a lateral direction relative to the corresponding screw within a range of 20 degrees, wherein the lateral direction is a direction in a plane perpendicular to the centerline of the spine.

36. The system of claim 28, wherein the distal portion of each of the plurality of rigid extensions is configured to rigidly couple with a corresponding one of the plurality of screws and / or a corresponding one of the plurality of screw heads, such that at least the distal portion of each of the plurality of rigid extensions is axially aligned with the corresponding screw and / or screw head and is prevented from rotating relative to each of the plurality of screws in an operable position.

37. The system according to claim 29, wherein: The proximal portion of the fourth rigid extension and the distal portion of the fourth rigid extension are laterally spaced a fourth distance apart when the fourth rigid extension is coupled to the fourth vertebra in the operable position. The proximal portion and the distal portion of the fifth rigid extension of the plurality of rigid extensions are laterally spaced apart by a fifth distance when the fifth rigid extension is coupled to the fifth vertebra in the operable position. The fourth distance is greater than the third distance; and The fifth distance is greater than the fourth distance.

38. The system of claim 28, wherein at least the intermediate portion of the plurality of rigid extensions is curved along the entire length of the intermediate portion, bent and / or angled along a length less than the entire length of the intermediate portion.

39. The system of claim 28, wherein the plurality of rigid extensions comprises generally straight rigid extensions.

40. The system of claim 28, further comprising a rod configured to couple with the plurality of screw heads, wherein the system is configured to move one or more vertebrae in a lateral direction when the rod is advanced toward the distal portion of the plurality of rigid extensions and engages with the plurality of screw heads.

41. The system of claim 40, wherein the system is configured to simultaneously advance the rod downward along the plurality of rigid extensions by incrementally advancing the rod toward the distal portion of each of the plurality of rigid extensions.

42. The system of claim 40, wherein the rod is substantially straight in at least the lateral direction.

43. The system of claim 40, wherein each of the plurality of rigid extensions has a groove extending from a proximal portion of each of the plurality of rigid extensions toward a distal portion of each of the plurality of rigid extensions, wherein the groove of each of the plurality of rigid extensions is configured to slidably receive the rod therein. This allows the rod to be guided toward the plurality of screw heads through the slots in the plurality of rigid extensions.

44. The system of claim 43, further comprising a plurality of actuating elements configured to advance along the groove between a proximal and a distal portion of each of the plurality of rigid extensions.

45. The system of claim 40 further includes a plurality of actuating elements configured to couple with the plurality of rigid extensions, and selectively moving the rod downward toward the distal portions of the plurality of rigid extensions toward the plurality of screw heads as the plurality of actuating elements advance toward the distal portions of the plurality of rigid extensions.

46. ​​The system of claim 40 further includes a plurality of threaded screws configured to thread engage with the plurality of rigid extensions, and selectively moving the rod downward toward the distal portions of the plurality of rigid extensions toward the screw heads as the plurality of screws are threadedly advanced toward the distal portions of the plurality of rigid extensions.

47. Systems for correcting scoliosis, including: Multiple screws configured to be implanted in multiple vertebrae, each of the multiple screws having a screw head; A plurality of rigid extensions configured to be detachably coupled to a plurality of screws, each of the plurality of rigid extensions having a proximal end, a distal end, a body portion and a proximal end connector, the distal end being configured to be detachably coupled to a screw head of each of the plurality of screws, the body portion being between the proximal end and the distal end, the proximal end connector being configured to close the proximal end of each of the plurality of rigid extensions, wherein the plurality of rigid extensions are curved along the entire length of the body portion or bent along a length less than the entire length of the body portion; and A rod configured to couple with the plurality of screw heads; The plurality of rigid extensions include: A first rigid extension, the first rigid extension including a proximal end, a distal end, and a body portion located between the proximal end and the distal end, and the first rigid extension including a first length extending between the proximal end and the distal end of the first rigid extension and a first curvature between the proximal end and the distal end of the first rigid extension; and The second rigid extension includes a proximal end, a distal end, and a main body portion located between the proximal end and the distal end, and the second rigid extension includes a second length extending between the proximal end and the distal end of the second rigid extension and a second curvature between the proximal end and the distal end of the second rigid extension, wherein the second length is different from the first length, and the second curvature is different from the first curvature. The system is configured such that the rod can be guided along the plurality of rigid extensions from the proximal end of the plurality of rigid extensions toward the distal end of the plurality of rigid extensions and engage with the plurality of screws.

48. The system of claim 47, wherein the system is configured to move one or more vertebrae in a lateral direction as the rod is advanced toward the distal end of the plurality of curved or bent rigid extensions and engages with the plurality of screw heads.

49. The system of claim 47, wherein the system is configured such that the rod can be simultaneously advanced downward along the plurality of rigid extensions by incrementally advancing the rod toward the distal end of each of the plurality of rigid extensions.

50. The system of claim 47, wherein the system is configured to move one or more vertebrae toward the transverse centerline of the spine when the rod is advanced toward the distal end of the plurality of rigid extensions.

51. The system of claim 48, wherein the rod is substantially straight in the transverse direction.

52. The system of claim 47, wherein each of the plurality of rigid extensions has a groove extending from a proximal end of each of the plurality of curved or bent rigid extensions to a distal end of each of the plurality of rigid extensions, wherein the groove of each of the plurality of rigid extensions is configured to slidably receive the rod therein. This allows the rod to be guided toward the plurality of screw heads by utilizing the grooves in the plurality of rigid extensions.

53. The system of claim 47, further comprising a plurality of actuating elements configured to couple with the plurality of rigid extensions, and selectively moving the rod downward toward the distal ends of the plurality of rigid extensions toward the plurality of screw heads as the plurality of actuating elements advance toward the distal ends of the plurality of rigid extensions.

54. The system of claim 53, wherein each of the plurality of actuating elements is selectively biased to prevent movement toward the proximal end of the plurality of rigid extensions as the plurality of actuating elements are advanced toward the distal end of the plurality of rigid extensions.

55. The system of claim 47 further includes a plurality of threaded actuating elements configured to thread-engage with the plurality of rigid extensions, and selectively moving the rod toward the distal end of the plurality of rigid extensions downward toward the plurality of screw heads as the plurality of actuating elements are threadedly advanced toward the distal end of the plurality of rigid extensions.

56. The system of claim 55, wherein the plurality of threaded actuating elements are a plurality of screws.

57. The system of claim 47, wherein each of the plurality of rigid extensions has a groove extending from a proximal end of each of the plurality of rigid extensions to a distal end of each of the plurality of rigid extensions, wherein the groove of each of the plurality of rigid extensions is configured to slidably receive the rod therein. This allows the grooves in the plurality of rigid extensions to guide the rod toward the plurality of screw heads.

58. The system of claim 57, further comprising a plurality of actuating elements configured to engage with the slot of each of the plurality of rigid extensions.

59. The system of claim 58, wherein the groove of each of the plurality of rigid extensions has an internal thread therein, the internal thread being configured to thread-engage with a plurality of thread-actuating elements capable of being threaded in the groove toward the distal end thread of the plurality of rigid extensions to advance the rod toward the plurality of screw heads.

60. The system of claim 47, wherein the system is configured to selectively prevent the rod from moving toward the proximal end of each of the plurality of rigid extensions as the rod is advanced toward the distal end of each of the plurality of rigid extensions.

61. The system of claim 47 further includes a plurality of guide elements configured to couple with the rod and slide along the plurality of rigid extensions from a proximal end of each of the plurality of rigid extensions toward a distal end of each of the plurality of rigid extensions to guide the rod toward the plurality of screw heads.

62. The system of claim 47, wherein at least one of the plurality of rigid extensions has at least one approximately straight portion along the length of the rigid extension.

63. The system according to claim 47, wherein: The plurality of screws includes a first plurality of screws and a second plurality of screws; The system is configured such that each of the first plurality of screws will be implanted into a plurality of vertebrae adjacent to each of the second plurality of screws; The plurality of rigid extensions includes a first plurality of curved or bent rigid extensions and a second plurality of curved or bent rigid extensions. Each of the first plurality of rigid extensions is configured to be detachably coupled to the screw head of each of the first plurality of screw heads; Each of the second plurality of rigid extensions is configured to be detachably coupled to the screw head of each of the second plurality of screw heads; The rod is a first rod, and the system includes a second rod; and The system is configured such that a first rod can be guided along a first plurality of rigid extensions from the proximal end of the first plurality of rigid extensions toward the distal end of the first plurality of rigid extensions and engage with a first plurality of screws, and a second rod can be guided along a second plurality of rigid extensions from the proximal end of the second plurality of rigid extensions toward the distal end of the second plurality of rigid extensions and engage with a second plurality of screws.

64. The system of claim 47, comprising: A first screw having a first screw head; A second screw with a second screw head; A third screw with a third screw head; A third rigid extension has a proximal end, a distal end configured to be detachably coupled to the third screw head, and a body portion located between the proximal end and the distal end, wherein at least a portion of the third rigid extension is curved along the entire length of the body portion or bent along a length less than the entire length of the body portion. in: The distal end of the first rigid extension is configured to be detachably coupled to the first screw head; and The distal end of the second rigid extension is configured to be detachably coupled to the second screw head.

65. The system according to claim 64, wherein: The main body of the first rigid extension has a first curvature; The main body of the second rigid extension has a second curvature; and The second curvature is different from the first curvature.

66. The system according to claim 64, wherein: The main body of the second rigid extension has a second curvature; The main body of the third rigid extension has a third curvature; and The third curvature is different from the second curvature.

67. The system of claim 47, wherein the plurality of rigid extensions have at least four different curvatures and / or lengths.

68. The system of claim 47, further comprising a plurality of locking caps, each locking cap configured to engage with the screw head of each of the plurality of screws.

69. The system of claim 47, further comprising a plurality of rod lowering devices configured to facilitate lowering the rod into the plurality of screw heads, each rod lowering device comprising: The main body portion has a channel configured to receive a corresponding one of the plurality of rigid extensions as the rod lowering device passes through them; A contact member configured to translate along the length of the main body portion of each rod lowering device and detachably coupled to the rod, the rod being configured to couple to the plurality of screw heads; in: Each body portion has a distal portion configured to be detachably coupled to the distal portion of a corresponding screw, a corresponding screw head, and / or a corresponding rigid extension; and The rod lowering device is configured to move the rod toward the screw head when the contact member moves toward the screw head.

70. The system of claim 69, wherein the body portion of one or more of the rod lowering devices has one or more grooves along its length, wherein each groove is configured to receive a portion therein when the contact member advances along the length of the body portion of the respective rod lowering device.

71. The system of claim 69, wherein the body portion of one or more of the rod lowering devices has one or more grooves along its length, wherein each groove is configured to receive a protrusion or wheel-like portion of the contact member therein when the contact member is advanced along the length of the body portion of the respective rod lowering device.

72. The system of claim 69, wherein the rod lowering devices are all straight.

73. The system of claim 69, wherein the rod lowering device is curved.

74. The system of claim 69, wherein the contact member is configured to roll or slide relative to the body portion.

75. The system of claim 69, wherein the channel is threaded.

76. The system of claim 69 further includes a threaded cap configured to be threaded downward toward the screw head along the channel and configured to be threadedly coupled to each of the plurality of screw heads to secure the rod to the plurality of screw heads.

77. The system of claim 69 further includes a force sensor coupled to the rod lowering device, the force sensor being configured to measure the level of force applied to the rod.

78. The system of claim 76 further includes a torque sensor configured to measure the level of torque applied to the cap.

79. Systems used to treat scoliosis include: Multiple screws, each configured to be implanted into a corresponding one of multiple vertebrae, each of the multiple screws having a screw head; and A plurality of rigid extensions, each configured to be detachably coupled to a corresponding one of the plurality of screws, each of the plurality of rigid extensions having a first guide configured to be coupled to a first side of the screw head and a second guide configured to be coupled to a second side of the screw head, the second side being opposite to the first side; in: The first guide and the second guide are laterally outwardly offset from the centerline axis of the plurality of rigid extensions, such that the width between the proximal portions of the first guide and the second guide is greater than the width between the distal portions of the first guide and the second guide. The plurality of rigid extensions include proximal connectors configured to couple the proximal ends of the first guide and the second guide; and The plurality of rigid extensions include: A first rigid extension, comprising: The first length extending between the proximal and distal ends of the first rigid extension, and The first curvature between the proximal and distal ends of the first rigid extension; and The second rigid extension includes: A second length extending between the proximal and distal ends of the second rigid extension; and A second curvature between the proximal and distal ends of the second rigid extension, wherein the second length is different from the first length, and the second curvature is different from the first curvature.

80. The system of claim 79, wherein the width between the proximal portions of the first guide and the second guide can be adjusted by the surgeon during the procedure for treating scoliosis.

81. The system of claim 79, wherein the width between the proximal portions of the first guide and the second guide is adjustable by the robot during the operation of treating scoliosis.

82. The system of claim 79 further includes a first rigid extension and a second rigid extension, wherein the width between the proximal portions of the first guide and the second guide of the first rigid extension is smaller than the width between the proximal portions of the first guide and the second guide of the second rigid extension.

83. The system of claim 82, further comprising a third rigid extension, wherein the width between the proximal portions of the first guide and the second guide of the second rigid extension is less than the width between the proximal portions of the first guide and the second guide of the third rigid extension.

84. The system of claim 83, further comprising a fourth rigid extension, wherein the width between the proximal portions of the first guide and the second guide of the third rigid extension is less than the width between the proximal portions of the first guide and the second guide of the fourth rigid extension.

85. The system of claim 84, further comprising a fifth rigid extension, wherein the width between the proximal portions of the first guide and the second guide of the fourth rigid extension is less than the width between the proximal portions of the first guide and the second guide of the fifth rigid extension.

86. The system of claim 85, further comprising a sixth rigid extension, wherein the width between the proximal portions of the first guide and the second guide of the fifth rigid extension is less than the width between the proximal portions of the first guide and the second guide of the sixth rigid extension.

87. The system of claim 79, wherein at least a portion of the first and second guides is curved along their entire length, bent along a length less than their entire length, and / or angled.

88. The system of claim 79, wherein the plurality of rigid extensions comprises generally straight rigid extensions.

89. The system of claim 79, further comprising a rod configured to couple with the plurality of screw heads, wherein the system is configured to move one or more vertebrae in a lateral direction when the rod is advanced toward the distal portion of the plurality of rigid extensions and engages with the plurality of screw heads.

90. Systems used to treat scoliosis include: Multiple screws, each configured to be implanted into a corresponding one of multiple vertebrae, each of the multiple screws having a screw head; A plurality of rigid extensions, each configured to be detachably coupled at its distal end to a corresponding one of the plurality of screws and / or screw heads, the plurality of rigid extensions including a first rigid extension and a second rigid extension, wherein the first rigid extension has a first length extending between a proximal end and a distal end and a first curvature between the proximal end and the distal end of the first rigid extension, and the second rigid extension has a second length extending between a proximal end and a distal end and a second curvature between the proximal end and the distal end of the second rigid extension, wherein the second length is different from the first length and the second curvature is different from the first curvature; Multiple guide members are configured to couple to the proximal portion of each of the multiple rigid extensions; and Alignment elements, which are configured to advance on the plurality of guide members; in: When the first guide member is coupled to the first rigid extension of the plurality of rigid extensions in the operable position, the proximal portion of the first guide member and the distal portion of the first guide member are laterally spaced apart by a first distance. When the second guide member is coupled to the second rigid extension of the plurality of rigid extensions in the operable position, the proximal portion of the second guide member and the distal portion of the second guide member are laterally spaced apart by a second distance. The second distance is greater than the first distance; and The system is configured to move one or more vertebrae toward the transverse centerline of the spine as the alignment element advances toward the distal portion of the plurality of guide members.

91. The system of claim 90, wherein when the third guide member of the plurality of guide members is coupled to the third rigid extension in an operable position, the proximal portion of the third guide member is laterally spaced from the distal portion of the third guide member by a third distance, and the third distance is greater than the second distance.

92. The system according to claim 91, wherein: When the fourth guide member of the plurality of guide members is coupled to the fourth rigid extension in the operable position, the proximal portion of the fourth guide member is laterally spaced apart from the distal portion of the fourth guide member by a fourth distance. When the fifth guide member of the plurality of guide members is coupled to the fifth rigid extension in the operable position, the proximal portion of the fifth guide member is laterally spaced from the distal portion of the fifth guide member by a fifth distance. The fourth distance is greater than the third distance; and The fifth distance is greater than the fourth distance.

93. The system of claim 90, wherein the system is configured such that the plurality of guide members are completely positioned outside the patient's body in an operable position.

94. The system of claim 90, wherein the system is configured such that when the alignment element is in an operable position adjacent to the distal portion of the plurality of guide members, the alignment element is completely positioned outside the patient's body.

95. The system of claim 90, wherein the plurality of guide members include guide members that are curved along their entire length, bent along a length less than their entire length, and / or angled.

96. The system of claim 90, wherein the plurality of guide members comprises at least one generally straight guide member.

97. The system of claim 90, further comprising a rod configured to couple with the plurality of screw heads to prevent the one or more vertebrae from moving away from the lateral centerline of the spine.

98. The system of claim 97, wherein the rod is substantially straight in at least one lateral direction.

99. The system of claim 97, wherein each of the plurality of rigid extensions has a groove extending from the proximal portion of each of the plurality of rigid extensions toward the distal portion of each of the plurality of rigid extensions, wherein the groove of each of the plurality of rigid extensions is configured to slidably receive the rod therein. This allows the rod to be guided toward the plurality of screw heads through the slots in the plurality of rigid extensions.

100. The system of claim 97, comprising a plurality of caps configured to advance via each of the plurality of rigid extensions to move the rod toward the plurality of screw heads.

101. A method of treating the spine using the system of claim 99, comprising pushing the rod in an axial direction through a single short incision, subsequently through the groove of the rigid extension.

102. The system of claim 90, wherein the distal portion of each of the plurality of guide members is coupled to the proximal end of the plurality of rigid extensions at a position laterally offset from the axial centerline of the plurality of rigid extensions.

103. Systems for correcting scoliosis, including: Multiple screws configured to be implanted into multiple vertebrae, each of the multiple screws having a screw head; A plurality of rigid guide elements, each configured to be fixed relative to a corresponding screw, each of the plurality of rigid guide elements having a proximal end and a distal end, the plurality of rigid guide elements being curved along their entire length or bent along a length less than their entire length; and A rod, the rod being configured to be guided along the plurality of rigid guide elements from the proximal end of the plurality of curved or bent rigid guide elements toward the distal end of the plurality of rigid guide elements, wherein the system is configured such that guiding the rod along the plurality of guide elements causes the plurality of vertebrae to move to correct the scoliosis. The plurality of rigid guide elements include: A first rigid guide element, the first rigid guide element including a first length extending between a proximal end and a distal end of the first rigid guide element and a first curvature between the proximal end and the distal end of the first rigid guide element, and A second rigid guide element includes a second length extending between a proximal end and a distal end of the second rigid guide element and a second curvature between the proximal end and the distal end of the second rigid guide element, wherein the second length is different from the first length and the second curvature is different from the first curvature.

104. The system of claim 103, wherein the distal ends of each of the plurality of rigid guide elements are each configured to be fixed relative to the screw head of a respective screw, and the rod is configured to be guided by the plurality of rigid guide elements into the screw head of the plurality of screws.

105. The system of claim 103 further includes a plurality of towers, each tower having a proximal end and a distal end, wherein the distal ends of the plurality of towers are each configured to be fixed relative to the screw head of a corresponding screw, and the distal ends of the plurality of rigid guide elements are each configured to be fixed to the proximal end of the corresponding tower.

106. The system of claim 105, wherein each of the plurality of towers includes an opening or slot configured to guide a spinal fixation rod into the screw head of the plurality of screws.

107. The system of claim 106, further comprising the spinal fixation rod, wherein the spinal fixation rod is separate from the rod, the rod being configured to be guided along the plurality of rigid guide elements.

108. The system of claim 105, wherein each of the plurality of towers further comprises a preloaded cap at the proximal end of each tower.

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