Spinal correction system and method

Abstract

A spinal implant (12) includes a first member (18) having an arcuate portion and a second member (20) having an arcuate portion. The first member is connected to a first portion of a vertebra and the second member is connected to a second portion of the vertebra such that the second portion of the vertebra is arranged at a first angle in a sagittal plane of the vertebra relative to the first portion of the vertebra. A ratchet (27) is provided with the members such that the first member is incrementally movable relative to the second member in the sagittal plane from the first angle to a selected angle of the second portion relative to the first portion. Systems, implants, and methods are disclosed.

Description

Technical Field

[0001] The present disclosure generally relates to medical devices for treating spinal disorders and, more particularly, to surgical systems and methods for correcting spinal disorders. Background Art

[0002] Spinal disorders such as scoliosis and other curvature abnormalities, kyphosis, degenerative disc disease, herniated discs, osteoporosis, spondylolisthesis, stenosis, tumors, and fractures can be caused by factors including trauma, disease, and degenerative conditions caused by injury and aging. Spinal disorders typically result in symptoms including pain, nerve damage, and partial or complete loss of mobility.

[0003] Nonsurgical treatments (such as medications, rehabilitation, and exercise) can be effective, however, may not relieve the symptoms associated with these disorders. Surgical treatments for these spinal disorders include correction, fusion, fixation, discectomy, laminectomy, and implantable prostheses. As part of these surgical treatments, spinal implants (such as tethers, bone fasteners, and spinal rods) can be used to provide stability to the spinal treatment area. These implants can redirect stress away from the damaged or defective area while healing occurs to restore proper alignment and generally support vertebral components. The present disclosure describes improvements to these prior arts. Summary of the Invention

[0004] In one embodiment, a spinal implant is provided. The spinal implant has a first member including an arcuate portion and a second member including an arcuate portion. The first member is connected to a first portion of a vertebra and the second member is connected to a second portion of the vertebra such that the second portion of the vertebra is disposed at a first angle relative to the first portion of the vertebra in the sagittal plane of the vertebra. A ratchet is provided with the members such that the first member is capable of incrementally moving relative to the second member in the sagittal plane from the first angle to a selected angle of the second portion relative to the first portion. In some embodiments, systems, implants, and methods are disclosed.

[0005] In some embodiments, the spinal implant includes a curved rod and a curved sleeve. The curved sleeve is connected to a first portion of a vertebra and the rod is connected to a second portion of the vertebra such that the second portion of the vertebra is disposed at a first angle relative to the first portion of the vertebra in the sagittal plane of the vertebra. A ratchet is provided with the sleeve and the rod such that the rod is capable of dynamically moving relative to the sleeve in the sagittal plane from the first angle to a selected angle of the second portion relative to the first portion.

[0006] In one embodiment, a spinal implant system is provided. The spinal implant system includes a spinal implant having a first member that includes an arcuate portion. A second member includes an arcuate portion. A ratchet is disposed within the members. The first member is connected to a first portion of a vertebra via a first bone fastener, and the second member is connected to a second portion of the vertebra via a second bone fastener such that the second portion of the vertebra is disposed at a first angle relative to the first portion of the vertebra in the sagittal plane of the vertebra. The first member is capable of incrementally moving relative to the first member from the first angle to a selected angle of the second portion relative to the first portion in the sagittal plane. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The present disclosure will be more readily understood in connection with the following drawings, in which:

[0008] Figure 1 is a perspective view of an embodiment of components of a surgical system in accordance with existing principles of the present disclosure;

[0009] Figure 2 is Figure 1 a perspective view of the components shown, with parts separated;

[0010] Figure 3 is Figure 1 an exploded cross-sectional view of the components of the system shown;

[0011] Figure 4 is Figure 1 an exploded cross-sectional view of the components of the system shown;

[0012] Figure 5 is Figure 1 a perspective view of the components of the system shown in ;

[0013] Figure 6 is Figure 1 an exploded cross-sectional view of the components of the system shown;

[0014] Figure 7 is Figure 1 an exploded cross-sectional view of the components of the system shown;

[0015] Figure 8 is Figure 1 a perspective view of the components of the system shown;

[0016] Figure 9 is Figure 1 a perspective view of the components of the system shown;

[0017] Figure 10 is Figure 1 a plan view of the components of the system shown;

[0018] Figure 11 A perspective view of an embodiment of a component of a surgical system according to existing principles of the present disclosure;

[0019] Figure 12 is Figure 11 A perspective view of a component of the system shown;

[0020] Figure 13 is Figure 11 An exploded view of a component of the system shown in;

[0021] Figure 14 A perspective view of an embodiment of a component of a surgical system according to the principles of the present disclosure with vertebrae provided;

[0022] Figure 15 A perspective view of an embodiment of a component of a surgical system according to the principles of the present disclosure with vertebrae provided;

[0023] Figure 16 An exploded cross-sectional view of an embodiment of a component of a surgical system according to the principles of the present disclosure; and

[0024] Figure 17 An exploded cross-sectional view of an embodiment of a component of a surgical system according to the principles of the present disclosure. DETAILED DESCRIPTION

[0025] Exemplary embodiments of a surgical system and related methods of use are discussed in accordance with a medical device for treating musculoskeletal disorders, and more particularly, in accordance with a surgical system and method for correcting spinal disorders. In some embodiments, the surgical system can be used in applications for correcting deformities (such as scoliosis and kyphosis). In some embodiments, the present surgical system includes a curved growing rod that is configured to incrementally extend in situ at an angle relative to the sagittal plane of the body after being implanted at a surgical site of a patient to provide stability to the spine during the patient's growth. In some embodiments, the rod is curved such that the natural anatomical curvature of the spine is formed.

[0026] In some embodiments, the surgical system includes a curved spinal extension rod. In some embodiments, the extension rod includes a tapered locking mechanism configured to lock the extension rod at a selected length. In some embodiments, the tapered locking mechanism is configured to lock the extension rod to prevent the extension rod from collapsing during normal patient movement. In some embodiments, an extension force is applied to a portion of the extension rod to facilitate extension of the extension rod. In some embodiments, the extension rod is configured for use in pediatric patients to provide stability to the spine during patient growth. In some embodiments, the extension rod is configured to be implanted at a surgical site including a portion of the patient's spine and is configured to incrementally extend in situ during patient growth. In some embodiments, the extension rod is configured to extend in situ without the need for multiple surgeries to extend the rod. In some embodiments, the extension rod is configured to extend at an angle to align with the natural curvature of the spine in the sagittal plane. In some embodiments, the extension rod facilitates the spine growing into a natural anatomical curvature. In some embodiments, the extension rod enables an increase in the patient's sagittal balance and improved growth. In some embodiments, the extension rod is implanted in a procedure for treating scoliosis.

[0027] In some embodiments, the surgical system includes a curved spinal extension rod connected to vertebrae via bone fasteners. In some embodiments, the bone fasteners include spinal screws and / or spinal hooks. In some embodiments, the extension rod includes ends configured for attachment to spinal screws or hooks. In some embodiments, the extension rod is configured to extend during patient growth. In some embodiments, the extension rod includes an extension section, such as a rod and a sleeve. In some embodiments, the rod and the sleeve are curved to mimic the natural sagittal curvature of the spine. In some embodiments, the angle between the ends of the extension rod changes as the extension rod extends. In some embodiments, the extension rod is positioned between a collapsed orientation and a fully extended orientation. In some embodiments, the angle between the collapsed orientation and the fully extended orientation can vary. In some embodiments, the angle between the collapsed orientation and the fully extended orientation includes a 40-degree angle. In some embodiments, the extension rod is configured to correct the patient's spine such that the spine is adjusted to have a 40-degree curvature at the end of full expansion of the extension rod, thereby paralleling the natural sagittal curvature of the thoracic spine.

[0028] In some embodiments, the surgical system includes a curved spinal extension rod that includes a curved rod and a curved sleeve. In some embodiments, a portion of the curved rod is configured to be disposed within the curved sleeve. In some embodiments, the curved sleeve is manufactured from a three-dimensional (3D) printed metal component, and the curved rod is manufactured by a machining process (e.g., computer numerical control (CNC) machining). In some embodiments, the extension rod includes a fixed end that is configured to engage an end of the curved sleeve. In some embodiments, the fixed end and the curved sleeve are a single integral piece. In some embodiments, the curved sleeve includes a detent pin that is configured to engage a slot on the curved rod to maintain the assembly of the curved rod and the curved sleeve. In some embodiments, the curved rod includes a plurality of grooves that are configured to engage a locking pin. In some embodiments, the extension rod includes a screw, a biasing member including a spring, a collar, and one or more locking pins. In some embodiments, the extension rod includes a pair of locking pins. In some embodiments, the extension rod includes a tapered locking mechanism that is configured to lock the extension rod at a selected length. In some embodiments, the tapered locking mechanism includes a biasing member that includes a spring. In some embodiments, the spring applies a selected amount of force on the collar to prevent the tapered locking mechanism from slipping such that the length of the extension rod is not incrementally adjustable without applying an extension force to the extension rod. In some embodiments, the curved sleeve includes a pair of tapered slots that include locking pins, and a compressive force is applied to the curved rod to wedge the locking pins between the tapered slots and the curved rod to lock the curved rod with the sleeve and prevent the extension rod from collapsing during normal movement of the patient. In some embodiments, an extension force is applied to the curved rod to facilitate extension of the extension rod. In some embodiments, the curved sleeve includes a pair of openings that are configured to assemble the locking pins with the extension rod such that the locking pins are disposed with the inner surface of the curved sleeve. In some embodiments, a surgical tool can be inserted into the openings to disengage the locking mechanism. In some embodiments, the surgical tool is configured to engage the collar and apply a force (e.g., an upward force) to the collar to disengage the locking mechanism.

[0029] In some embodiments, the surgical system includes a curved spinal extension rod that includes a curved rod and a curved sleeve having a pawl, such as a spring-loaded pawl configured to lock the curved rod to the curved sleeve. In some embodiments, the curved rod defines a plurality of teeth or a plurality of grooves. In some embodiments, the spring-loaded pawl is configured to engage the plurality of teeth or the plurality of grooves. In some embodiments, the curved sleeve includes a cam, such as a spring-loaded cam configured to engage the curved rod. In some embodiments, the curved rod does not include a plurality of teeth or a plurality of grooves that engage the spring-loaded cam.

[0030] In some embodiments, the present surgical system is used in a method for treating spinal disorders in a patient. In some embodiments, the method includes the steps of fixing a bone fastener to a first portion of a vertebra and fixing a second bone fastener to a second portion of the vertebra. In some embodiments, the method includes the step of fixing a spinal implant with a bone fixation member. In some embodiments, the spinal implant includes a rod having an arcuate portion, a sleeve having an arcuate portion, and a ratchet provided with the sleeve and the rod. In some embodiments, the spinal implant is fixed to the bone fasteners such that the second portion of the vertebra is arranged at a first angle in the sagittal plane of the vertebra relative to this portion of the vertebra. In some embodiments, the rod is capable of incrementally moving from a first angle to a selected angle of the second portion relative to the first portion in the sagittal plane relative to the sleeve. In some embodiments, the present system and / or method provides incremental adjustment such that the patient's spine is corrected to have a curvature of 40 degrees, thereby parallel to the natural sagittal curvature of the thoracic spine.

[0031] In some embodiments, the present surgical system is configured to be used with surgical navigation (e.g., fluoroscopy or image guidance). In some embodiments, one or all of the components of the surgical system are disposable, peel-packaged, pre-packaged sterile devices. One or all of the components of the surgical system may be reusable. The surgical system may be configured as a kit having components of multiple sizes and configurations.

[0032] In some embodiments, the present disclosure can be used to treat spinal disorders such as, for example, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumors, and fractures. In some embodiments, the present disclosure can be used for other bone and bone-related applications, which include applications associated with diagnosis and treatment. In some embodiments, the disclosed surgical system and method can alternatively be used for surgical treatment of a patient in a prone, supine position, lateral, and / or for various surgical approaches to the spine and in other body regions, including anterior, posterior, posterior midline, anterolateral, posterolateral, and / or anterolateral approaches. The present disclosure can also alternatively be used in conjunction with procedures for treating the lumbar, cervical, thoracic, sacral, and pelvic regions of the spine. The systems and methods of the present disclosure can also be used on animals, bone models, and other non-living substrates, such as for training, testing, and demonstration.

[0033] The following detailed description of the reference embodiments, in conjunction with the accompanying drawings, which form a part of the present disclosure, will enable a better understanding of the present disclosure. It should be understood that the present application is not limited to the specific devices, methods, conditions or parameters described and / or illustrated herein, and the terms used herein are merely used to describe specific embodiments by way of example and are not intended to be limiting. In some embodiments, as used in the specification and including the appended claims, the singular forms "a" and "the" include the plural, and the reference to a specific numerical value includes at least that specific value, unless the context clearly dictates otherwise. Ranges may be expressed herein as "about" or "approximately" a particular value and / or "about" or "approximately" another particular value. When expressing such a range, another embodiment includes from one particular value and / or to another particular value. Similarly, when a value is expressed as an approximation by use of the antecedent "about", it should be understood that the particular value forms another embodiment. It should also be understood that all spatial references (e.g., horizontal, vertical, top, upper, lower, bottom, left and right) are for illustrative purposes only and may vary within the scope of the present disclosure. For example, references to "upper" and "lower" are relative and are used in another context only, and are not necessarily "up" and "down".

[0034] As used in this specification and the appended claims, "treatment" of a disease or condition refers to a procedure that may include administering one or more drugs to a patient (human, normal or other person or other mammal), using an implantable device, and / or using an instrument for treating the disease (e.g., a microdiscectomy instrument for removing a portion of a herniation or disc protrusion and / or bone spur) to relieve the signs or symptoms of the disease or condition. Relief may occur before or after the signs or symptoms of the disease or condition appear. Thus, treatment includes preventing a disease or adverse condition (e.g., preventing a disease from occurring in a patient who may be predisposed to the disease but has not yet been diagnosed as having the disease). Additionally, treatment does not require complete relief of signs or symptoms, does not require a cure, and specifically includes procedures that have only a minimal effect on the patient. Treatment may include suppressing a disease, e.g., preventing its progression or alleviating a disease, e.g., causing the disease to regress. For example, treatment may include reducing acute or chronic inflammation; alleviating and relieving pain and promoting the regrowth of new ligaments, bone, and other tissues; as an adjunct to surgery; and / or any repair procedure. As used in the specification and including the appended claims, the term "tissue" includes soft tissue, ligament, tendon, cartilage, and / or bone, unless otherwise specifically stated.

[0035] The following discussion includes a description of a surgical system and related methods of using the surgical system in accordance with the principles of the present disclosure. Alternative embodiments are also disclosed. Reference is made in detail to the exemplary embodiments of the present disclosure shown in the drawings. Turning to Figures 1 to 15, showing the components of a surgical system (e.g., spinal correction system 10).

[0036] The components of the spinal correction system 10 can be made of biocompatible materials suitable for medical applications, including metals, synthetic polymers, ceramics, and bone materials and / or their composites. For example, the components of the spinal implant system 10 can be made, individually or jointly, of materials such as stainless steel alloys, commercially pure titanium, titanium alloys, grade 5 titanium, superelastic titanium alloys, cobalt-chromium alloys, superelastic metallic alloys (e.g., Nitinol, superelastic metals such as GUM ), ceramics and their composites (such as calcium phosphates (e.g., SKELITE TM ), thermoplastics (such as polyaryletherketones (PAEK), including polyetheretherketone (PEEK), polyetherketoneketone (PEKK), and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO 4 polymer rubbers, polyethylene terephthalate (PET)), fabrics, silicones, polyurethanes, silicone-polyurethane copolymers, polymer rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermosetting elastomers, elastomer composites, rigid polymers (including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy resins), bone materials (including autograft, allograft, xenograft, or transgenic cortical bone and / or cancellous bone, and tissue growth or differentiation factors), partially absorbable materials (e.g., composites of metals and calcium-based ceramics, composites of PEEK and calcium-based ceramics, composites of PEEK and absorbable polymers), fully absorbable materials (e.g., calcium-based ceramics such as calcium phosphate, tricalcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate, or other absorbable polymers such as polylactide, polyglycolide, polytyrosine carbonate, polycaprolactone), and combinations thereof.

[0037] The various components of the spinal correction system 10 can have composite materials, including the above materials, to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical properties, durability, and radiopacity or imaging preference. The components of the spinal correction system 10 can also be made, individually or jointly, of heterogeneous materials, e.g., combinations of two or more of the above materials. The components of the spinal correction system 10 can be integrally formed, integrally connected, or include fastening elements and / or instruments, as described herein.

[0038] The spinal correction system 10 includes spinal implants, such as growth rods 12, as Figure 1 and Figure 2As shown. The growth rod 12 is configured to extend at an angle relative to the sagittal plane of the patient after implantation at the surgical site to provide spinal stability during patient growth. In some embodiments, the growth rod 12 is configured to incrementally extend in situ at an angle relative to the sagittal plane. In some embodiments, the growth rod 12 is curved such that a natural anatomical curvature found in a healthy spine is formed within the patient. The growth rod 12 extends between an end 14 and an end 16 and defines a longitudinal axis AA (as Figure 8 shown). The end 14 includes a member (e.g., rod 18), and the end 16 includes a member (e.g., sleeve 20).

[0039] The rod 18 extends between an end 22 and an end 24. The end 22 is configured to be connected to a portion of a vertebra via a bone fastener 100a as described herein. As Figure 6 shown, the end 24 is configured to be disposed with the sleeve 20 and is capable of incrementally moving relative to the sleeve 20 via a ratchet 27. In some embodiments, a portion of the rod 18 is disposed in a telescoping configuration with the sleeve 20. In some embodiments, the rod 18 is capable of in situ dynamic expansion in an outward direction of the sleeve 20 as described herein.

[0040] The rod 18 is curved and includes an arcuate portion. The rod 18 includes a side 26 and an opposite side 28. The outer surface of the side 26 defines a portion of the ratchet 27 that includes a plurality of grooves 30, and the side 28 defines a portion of the ratchet 27 that includes a plurality of grooves 32. The grooves 30, 32 are transverse grooves. The grooves 30, 32 are configured to engage a portion of the ratchet 27 that includes a pair of pins 34, 36, which are configured to be disposed with tapered slots 38, 40 of the sleeve 20 for incremental adjustment of the rod 18 relative to the sleeve 20 as described herein. The pins 34, 36 can be disposed in an expandable orientation with the tapered slots 38, 40 to allow the rod 18 to move relative to the sleeve 20 in one direction (e.g., Figure 7 the upward or outward direction as indicated by arrow A of Figure 7 ), and the pins 34, 36 can be disposed in a locking orientation with the tapered slots 38, 40 to prevent the rod 18 from moving and collapsing relative to the sleeve 20 in the opposite direction (e.g.,

[0041] the downward or inward direction as indicated by arrow B of Figures 3 to 5As shown. The side surface 42 includes an outer surface that defines an axial slot 46. The slot 46 is configured as a stop to limit the translation of the rod 18 relative to the sleeve 20. The slot 46 includes an end 50 that defines the translation limit and an end 52 that defines the translation limit of a pin 54 disposed together with the sleeve 20. The rod 18 is capable of moving relative to the sleeve 20 between the limits defined from end 50 to end 52 via the pin 54. In some embodiments, the slot 46 and the pin 54 are configured to movably secure the rod 18 and the sleeve 20 such that the rod and the sleeve remain in the assembled configuration. In some embodiments, the slot 46 may have an alternative surface configuration (e.g., rough, threaded, arcuate, wavy, porous, semi-porous, pitted, polished, and / or textured) to enhance the engagement with the pin 54.

[0042] The sleeve 20 extends between an end 62 and an end 64, as Figure 2 shown. The end 62 is configured for engagement with the end 24 of the rod 18. The end 64 is configured to be connected to a portion of a vertebra via the bone fastener 100b described herein. The sleeve 20 is curved and includes an arcuate portion. The sleeve 20 is configured to be connected to a portion of a vertebra that is disposed at an angle α1 ( Figure 8 ) relative to the axis AA and relative to the portion of the vertebra connected to the rod 18. In some embodiments, the angle α1 is disposed in the sagittal plane of the vertebra, as described herein.

[0043] The slot 20 includes a portion of a ratchet 27 that includes tapered slots 38, 40 that are configured for engagement with pins 34, 36 that engage grooves 30, 32 for incremental adjustment of the rod 18 relative to the sleeve 20, as Figure 6 and Figure 7 shown, as described herein. The ratchet 27 is configured to incrementally move the rod 18 relative to the sleeve 20 from an angle α1 to a selected angle α2 ( Figure 9 ) relative to the axis AA disposed in a selected plane of the vertebra. In some embodiments, the ratchet 27 is configured to incrementally move the rod 18 relative to the sleeve 20 from an angle α1 to a selected angle α2 relative to the axis AA disposed in the sagittal plane of the vertebra. In some embodiments, the selected angle α2 is in the range of 1 degree to 40 degrees. The slot 38 includes an end 66 and an end 68 that are configured for engagement with the pin 34. The slot 40 includes an end 70 and an end 72 that are configured for engagement with the pin 36.

[0044] The collar 74 is configured to engage with the slots 38, 40, pins 34, 36, and is disposed around the rod 18. A biasing member (e.g., spring 76) is configured to engage with the collar 74 and is configured to be disposed around the rod 18. The screw 78 is configured to threadedly engage with the end 62 of the sleeve 20. The spring 76 is configured to engage with the screw 78 and a portion of the rod 18, and is configured to be disposed with the screw 78.

[0045] The pins 34, 36 can be disposed in an expandable orientation with the tapered slots 38, 40 to allow the rod 18 to move relative to the sleeve 20 in an upward or outward direction, as Figure 9 shown, and the pins 34, 36 can be disposed in a locking orientation with the tapered slots 38, 40 to prevent the rod 18 from moving relative to the sleeve 20 in the opposite direction (e.g., downward or inward direction) and collapsing, as Figure 8 shown. In the expandable orientation, the expansion force (e.g., the force applied during traction of the patient) facilitates the in-situ extension of the rod 18. In the locking orientation, the spring 76 applies a selected amount of force on the collar 74 to prevent the rod 18 from moving, e.g., preventing it from moving during normal movement of the patient. In the locking orientation, the compressive force applied to the rod 18 via the spring 76 causes the pins 34, 36 to wedge between the tapered slots 38, 40, thereby locking the rod 18 to the sleeve 20. In some embodiments, the rod 18 and the sleeve 20 are biased to hold the pins 34, 36 in the locking orientation.

[0046] The outer surface of the sleeve 20 defines openings 80, 82 that are configured to engage with a surgical tool 84, as Figure 13 and Figure 14 shown. The tool 84 includes clamps 86, 88 that are configured to be disposed within the openings 80, 82 to disengage and unlock the rod 18 via engagement with the collar 74. The tool 84 is configured to apply a force on the collar 74, e.g., an upward force, to disengage the rod 18. The outer surface of the sleeve 20 defines openings 90, 92 that are configured to engage with the pins 34, 36 such that the pins 34, 36 can be assembled with the growth rod 12.

[0047] The end 64 of the sleeve 20 is configured to threadedly engage with a straight rod 94, as Figure 2 shown. In some embodiments, the end 64 and the rod 94 are a single integral piece. In some embodiments, the rod 94 can include overall and / or cross-sectional configurations, e.g., cylindrical, circular, oval, rectangular, polygonal, irregular, tapered, offset, staggered, uniform, and non-uniform.

[0048] In some embodiments, the rod 18 is configured to be connected to a portion of a vertebra via a bone fastener 100a, and the sleeve 20 is configured to be connected to a portion of a vertebra via a bone fastener 100b, as Figure 14 shown. In some embodiments, the bone fasteners 100a, 100b include spinal screws and / or spinal hooks. In some embodiments, the spinal correction system 10 may include one or more bone fasteners 100a, 100b (such as the bone fasteners described herein) and / or fixation elements, which may be used at a single vertebral level or multiple vertebral levels. In some embodiments, the bone fasteners 100a, 100b may engage the vertebrae in various orientations, such as serial, parallel, offset, staggered, and / or alternating vertebral levels. In some embodiments, the bone fasteners 100a, 100b may be configured as multi-axial screws, sagittally angled screws, pedicle screws, uni-axial screws, uni-planar screws, fixation screws, anchors, tissue penetrating screws, conventional screws, expansion screws. In some embodiments, the bone fasteners 100a, 100b may be used in conjunction with wedges, anchors, buttons, clips, clasps, friction fittings, compression fittings, expansion rivets, staples, nails, adhesives, posts, connectors, fixing plates, and / or columns.

[0049] In assembly, operation, and use, a spinal correction system 10 similar to the systems and methods described herein is used in conjunction with a surgical procedure, such as, for example, a corrective treatment of an affected portion of the spine, which may include, for example, a corrective treatment for adolescent idiopathic scoliosis and / or Scheuermann's kyphosis of the spine. In some embodiments, one or all of the components of the spinal correction system 10 may be delivered or implanted as a pre-assembled device, or may be assembled in situ. The spinal correction system 10 may be modified, removed, or replaced in whole or in part.

[0050] In use, to treat a selected segment of a vertebra V, as Figure 14 and Figure 15 shown, a medical practitioner gains access to the surgical site including vertebra V in any suitable manner, such as by incising and retracting tissue. In some embodiments, the spinal correction system 10 may be used with any existing surgical method or technique, including open surgery, mini-open surgery, minimally invasive surgery, and percutaneous surgical implantation, whereby the vertebra V can be accessed through a mini-incision or a sleeve providing protected access to the area. Once access to the surgical site is obtained, a specific surgical procedure may be performed to treat the spinal condition.

[0051] An incision is made in the patient's body, and a cutting instrument (not shown) forms a surgical path for implanting components of the spinal correction system 10. A preparation instrument (not shown) can be used to prepare the tissue surface of the vertebra V, and for aspiration and irrigation of the surgical area.

[0052] The growth rod 12 is delivered along the surgical path to the surgical site. The end 22 of the rod 18 is fixed to the vertebra V1 via a bone fastener 100a, and the end 64 of the sleeve 20 is fixed to the vertebra V2 via a bone fastener 100b. The growth rod 12 is fixed to the surgical site in a collapsible orientation at an angle α1. During the patient's growth, the growth rod 12 is configured to incrementally expand in situ via components of the ratchet 27 described herein, such that the angle α1 can be expanded to an angle α2 via the expansion of the rod 18 relative to the sleeve 20, such that the patient's spine is corrected. In some embodiments, the angle α1 can be expanded to the angle α2 such that the patient's spine is corrected to the angle α2, which can include an angle in the range of 1 degree to 40 degrees, and for example a 40-degree curvature, so as to be parallel to the natural sagittal curvature of the thoracic spine. In some embodiments, a tensile force is applied to the growth rod 12, including the force applied during traction of the patient, to facilitate the expansion of the rod 18 relative to the sleeve 20.

[0053] In some embodiments, the growth rod 12 is configured to extend in situ without the need for multiple surgeries to extend the growth rod 12. In some embodiments, the rod 18 is configured to extend to the angle α2 to align with the natural curvature of the spine in the sagittal plane. In some embodiments, the growth rod 12 facilitates the growth of the spine into a natural anatomical curvature.

[0054] After completion of the procedure, the surgical instruments, components, and non-implantable parts of the spinal correction system 10 are removed from the surgical site, and the incision is closed. One or more of the components of the spinal correction system 10 can be made of a radiopaque material such as a polymer. A radiological marker can be included, which is used for identification under x-ray, fluoroscopy, CT, or other imaging techniques. In some embodiments, the use of surgical navigation, microsurgery, and image-guided techniques can be used to access, view, and repair spinal deterioration or injury with the aid of the spinal correction system 10.

[0055] In some embodiments, the spinal correction system 10 includes a medicament, which can be set, encapsulated, coated, or layered within, on, or around the components and / or surfaces of the spinal correction system 10. In some embodiments, the medicament can include a bone growth promoting material such as, for example, a bone graft, to enhance the fixation of the bone fastener to the vertebra. In some embodiments, the medicament can include one or more therapeutic and / or pharmacological agents for release (including sustained release) to treat, for example, pain, inflammation, and degeneration.

[0056] In some embodiments, the components of the spinal correction system 10 can be used to treat progressive idiopathic scoliosis, with or without radial deformity, in infant or adolescent patients, including but not limited to pre-pubescent children, 10-12 year old adolescents with continued growth potential, and / or older children with late growth spurts or otherwise retained growth potential. In some embodiments, the components of the spinal correction system 10 can be used to prevent or minimize curve progression in individuals of different ages.

[0057] In one embodiment, as Figure 16 shown, the spinal correction system 10 (similar to the systems and methods described above with respect to Figures 1 to 15 ) includes a growth rod 212 (similar to the growth rod 12 described herein). The growth rod 212 includes a member (e.g., rod 218) similar to the rod 18 described herein and a member (e.g., sleeve 220) similar to the sleeve 20 described herein. The rod 218 and the sleeve 220 are curved. The rod 218 is configured to be disposed with the sleeve 220 and is capable of incrementally moving relative to the sleeve 220 via a ratchet 227.

[0058] The rod 218 includes an outer surface defining a plurality of teeth 230 that are configured to engage with a spring-loaded pawl 232 disposed within the inner surface of the sleeve 220. The teeth 230 and the pawl 232 form the ratchet 227. The engagement of the teeth 230 and the pawl 232 is configured for incremental adjustment of the rod 218 relative to the sleeve 220, similar to that described herein. The rod 212 is configured to be disposed in an expandable orientation similar to that described herein to allow the rod 218 to move relative to the sleeve 220 in one direction (e.g., the upward or outward direction as indicated by arrow C in Figure 16 ), and the rod 212 can be disposed in a locked orientation similar to that described herein to prevent the rod 218 from moving and collapsing relative to the sleeve 220 in the opposite direction (e.g., the downward or inward direction as indicated by arrow D in Figure 16 ). In some embodiments, the teeth 230 alternatively include a plurality of grooves configured to engage with the pawl 232. In some embodiments, the sleeve 220 includes a plurality of pawls 232.

[0059] In one embodiment, as Figure 17 shown, the spinal correction system 10 (similar to the systems and methods described above with respect to Figures 1 to 15 ) includes a growth rod 312 (similar to the growth rod 12 described herein). The growth rod 312 includes a member (e.g., rod 318) similar to the rod 18 described herein and a member (e.g., sleeve 320) similar to the sleeve 20 described herein. The rod 318 and the sleeve 320 are curved. The rod 318 is configured to be disposed with the sleeve 320 and is capable of incrementally moving relative to the sleeve 320 via a ratchet 327.

[0060] The rod 318 includes an outer surface 330 that is configured to engage a biasing cam 332 disposed within an inner surface of the sleeve 320. The surfaces 330 and 332 form a ratchet 327. The engagement of the surfaces 330 and 332 is configured for incremental adjustment of the rod 318 relative to the sleeve 320. The rod 312 is configured to be disposed in an expandable orientation similar to that described herein to allow the rod 318 to move relative to the sleeve 320 in one direction (e.g., Figure 17 the upward or outward direction as indicated by arrow E of Figure 17 ), and the rod 312 can be disposed in a locking orientation similar to that described herein to prevent the rod 318 from moving and collapsing relative to the sleeve 320 in the opposite direction (e.g.,

[0061] the downward or inward direction as indicated by arrow F of ). In some embodiments, the surface 330 may include a plurality of teeth or grooves configured to engage the cam 332. In some embodiments, the sleeve 320 includes a plurality of cams 332.

[0061] It should be understood that various modifications can be made to the embodiments disclosed herein. Accordingly, the above description should not be construed as limiting, but merely as illustrative of various embodiments. Those skilled in the art can envision other modifications within the scope and spirit of the appended claims herein.

Claims

1. A spinal implant, the spinal implant comprises: a first member, the first member comprising an arcuate portion; a second member, the second member comprising an arcuate portion, the first member being connected to a first portion of a vertebra, and the second member being connected to a second portion of the vertebra such that the second portion of the vertebra is arranged at a first angle relative to the first portion of the vertebra in the sagittal plane of the vertebra; and a ratchet, the ratchet being provided together with the members such that the first member is capable of incrementally moving relative to the second member in the sagittal plane from the first angle to a selected angle of the second portion relative to the first portion.

2. The spinal implant according to claim 1, wherein the first member comprises a plurality of grooves, and the second member comprises a tapered slot configured to receive at least one pin.

3. The spinal implant according to claim 2, wherein the at least one pin can be arranged with the slot in a first orientation to allow the first member to move relative to the second member in a first direction, and the at least one pin can be arranged with the slot in a second orientation to prevent the first member from moving relative to the second member in an opposite second direction.

4. The spinal implant according to claim 3, wherein the members are biased to hold the at least one pin in the second orientation.

5. The spinal implant according to claim 2, wherein the at least one pin comprises a collar, the collar comprising two pins arranged around the first member.

6. The spinal implant according to claim 1, wherein the members are capable of relative movement between a selected first limit and a selected second limit.

7. The spinal implant according to claim 6, wherein the first member comprises at least one groove, and the second member comprises at least one stop, the at least one stop being capable of engaging to define at least one of the first limit or the second limit.

8. The spinal implant according to claim 1, wherein the members are capable of in-situ dynamic expansion in a first direction.

9. The spinal implant according to claim 1, wherein the selected angle is in the range of 1 degree to 40 degrees.

10. The spinal implant according to claim 1, wherein a portion of the first member is arranged in a telescopic configuration with the second member.

11. The spinal implant according to claim 1, wherein the ratchet comprises a pawl capable of engaging with a plurality of teeth.

12. The spinal implant according to claim 1, wherein the ratchet comprises a biasing cam capable of engaging with the first member.

13. A spinal implant, the spinal implant comprises: a curved rod; a curved sleeve, the curved sleeve being connected to a first portion of a vertebra and the rod being connected to a second portion of the vertebra such that the second portion of the vertebra is arranged at a first angle relative to the first portion of the vertebra in the sagittal plane of the vertebra; and A ratchet, the ratchet being provided together with the sleeve and the rod such that the rod can move dynamically from the first angle to a selected angle of the second part relative to the first part in the sagittal plane relative to the sleeve.

14. The spinal implant according to claim 13, wherein the sleeve includes a tapered slot configured to receive at least one pin, and the rod includes a plurality of grooves such that the sleeve and the rod can expand incrementally.

15. The spinal implant according to claim 14, wherein the at least one pin can be disposed with the slot in a first orientation to allow the rod to move relative to the sleeve in a first direction, and the at least one pin can be disposed with the slot in a second orientation to prevent the rod from moving relative to the sleeve in a second direction.

16. The spinal correction implant according to claim 13, wherein the at least one pin includes a collar, the collar including two pins disposed around the rod.

17. The spinal correction implant according to claim 13, wherein the sleeve and the rod can move relative to each other between a selected first limit and a selected second limit, the rod includes at least one groove, and the sleeve includes at least one stop, the at least one stop being engageable to define at least one of the first limit or the second limit.

18. A spinal implant system, the spinal implant system comprising: a spinal implant including a first member having an arcuate portion, a second member having an arcuate portion, and a ratchet provided together with the members; a first bone fastener; and a second bone fastener, the first member being connected to a first part of a vertebra via the first bone fastener, and the second member being connected to a second part of the vertebra via the second bone fastener such that the second part of the vertebra is arranged at a first angle in the sagittal plane of the vertebra relative to the first part of the vertebra, the first member being able to move incrementally relative to the second member in the sagittal plane from the first angle to a selected angle of the second part relative to the first part.

19. The spinal implant system according to claim 18, wherein the second member includes a sleeve having a tapered slot configured to receive at least one pin, and the first member includes a rod, the rod including a plurality of grooves such that the sleeve and the rod can expand incrementally.

20. The spinal implant system according to claim 19, wherein the at least one pin can be disposed with the slot in a first orientation to allow the rod to move relative to the sleeve in a first direction, and the at least one pin can be fixed with the slot in a second orientation to prevent the rod from moving relative to the sleeve in a second direction.

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