Spinal implant connector and method

Abstract

A connector includes a first receiver that defines an implant cavity and includes a mating surface. A second receiver is attachable to the first receiver via a flexible element, the second receiver defining an implant cavity and including a mating surface that can engage with the mating surface of the first receiver to fix the relative orientation of the receivers. A biasing element is disposed adjacent to the mating surface to space the mating surface so that in operation of the connector, the first receiver can move relative to the second receiver. Systems, surgical instruments, implants, spinal constructs, and methods are disclosed.

Description

Technical Field

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

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

[0003] Non-surgical treatments, such as medication, rehabilitation and exercise may be effective, however, may not alleviate the symptoms associated with these conditions. The surgical treatments for these spinal conditions include correction, fusion, fixation, discectomy, laminectomy and implantable prostheses. As part of these surgical treatments, spinal structures comprising vertebral rods are generally used to provide stability to the treatment area. When healing, the rods transfer stress from the damaged or defective area to carry out appropriate correction and generally provide support for the vertebral members. During surgical treatment, one or more rods and bone fasteners can be delivered to the surgical site. The rods can be attached to the outside of two or more vertebral members via fasteners. In some cases, as part of surgical treatment, the rods are interconnected. The present disclosure describes improvements to these prior arts. Summary of the invention

[0004] In one embodiment, a connector is provided. The connector includes a first receiver, the first receiver defining an implant cavity and including a mating surface. A second receiver can be attached to the first receiver via a flexible element, the second receiver defining an implant cavity and including a mating surface, the mating surface can engage with the mating surface of the first receiver to fix the relative orientation of the receiver. A biasing element is disposed adjacent to the mating surface to space the mating surface so that during operation of the connector, the first receiver can move relative to the second receiver. In some embodiments, systems, surgical instruments, spinal constructs, implants, and methods are disclosed.

[0005] In one embodiment, a method of assembling a spinal implant is provided. The method includes the steps of aligning a surface of a first receiver with a surface of a second receiver to define a passageway, introducing a flexible element through one of the receivers adjacent to the passageway, and positioning the flexible element in the passageway to attach the first receiver to the second receiver.

[0006] In one embodiment, a method for treating a spine is provided. The method includes the steps of: placing a first spinal rod with a first receiver of a spinal implant, the first receiver having a mating surface and the spinal implant including a second receiver attachable to the first receiver via a flexible element, the second receiver having a mating surface, and a biasing element disposed adjacent to the mating surface to space the mating surface so that the first receiver is movable relative to the second receiver; placing a second spinal rod with the second receiver; and engaging the mating surfaces to fix the relative orientation of the receivers. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The present disclosure will become more apparent from the detailed description accompanying the following drawings, in which:

[0008] Figure 1 is a side view of components of one embodiment of a system according to principles of the present disclosure;

[0009] Figure 2 yes Figure 1 a bottom view of the components shown;

[0010] Figure 3 yes Figure 1 a side view of a first receiver of the illustrated system;

[0011] Figure 4 yes Figure 1 a side view of a second receiver of the illustrated system;

[0012] Figure 5 is a perspective exploded view of components of one embodiment of a system according to principles of the present disclosure;

[0013] Figure 6 is a side exploded view of components of one embodiment of a system according to principles of the present disclosure;

[0014] Figure 7 is a first perspective view of a cutaway phantom of components of one embodiment of a system according to principles of the present disclosure;

[0015] Figure 8 is a second perspective view of a cutaway phantom of components of one embodiment of a system according to principles of the present disclosure;

[0016] Fig. 9 is along Figure 8 a cross-sectional view of components of the system taken along line AA;

[0017] Fig.10 is along Figure 8 a cross-sectional view of components of the system taken along line BB;

[0018] Fig.11is a side cross-sectional view of components of one embodiment of a system according to principles of the present disclosure;

[0019] Fig.12 yes Fig.11 a side cross-sectional view of the components shown in ;

[0020] Fig.13 is a side view of components of one embodiment of a system according to principles of the present disclosure;

[0021] Fig.14 is a perspective view of components of one embodiment of a system for placement with a vertebra according to the principles of the present disclosure;

[0022] Fig.15 is a perspective view of components of one embodiment of a system for placement with a vertebra according to the principles of the present disclosure;

[0023] Fig.16 is a side view of components of one embodiment of a system according to principles of the present disclosure;

[0024] Fig.17 is a side view of components of one embodiment of a system according to principles of the present disclosure;

[0025] Fig.18 is a side view of components of one embodiment of a system according to principles of the present disclosure; and

[0026] Fig.19 is a side view of components of one embodiment of a system according to principles of the present disclosure. DETAILED DESCRIPTION

[0027] Exemplary embodiments of the disclosed surgical systems and related methods of use are discussed in terms of medical devices for treating musculoskeletal disorders, and more particularly, in terms of surgical systems and methods for treating spinal disorders. In some embodiments, the disclosed systems and methods are used for spinal arthrodesis, such as employed in conjunction with the cervical, thoracic, lumbar, and / or sacral regions of the spine.

[0028] In some embodiments, the surgical system of the present invention comprises a spinal construct comprising a connector. In some embodiments, the surgical system of the present invention comprises a spinal construct comprising a variable angle domino connector. In some embodiments, the surgical system of the present invention comprises a spinal construct comprising one or more minimally invasive revision surgery connectors. In some embodiments, the surgical system of the present invention comprises a spinal construct that can be used in conjunction with a method of treating the spine with multiple spinal rods, which can be used to hold the spine until fusion occurs. In some embodiments, the surgical system of the present invention comprises a spinal construct that can be used in conjunction with a method of treating the spine, the method comprising pedicle subtraction osteotomy, three column osteotomy, transforaminal lumbar interbody fusion (TLIF) and / or long constructs for critically ill patients.

[0029] In some embodiments, the surgical system of the present invention includes a spinal structure including an inter-rod connector, which is used to connect two rods in a multi-rod structure or to extend an existing structure. In some embodiments, the relative sides of the connector move independently and allow rods with different profiles to be connected without the need for additional manipulation of the rod. In some embodiments, the connector includes an open part. In some embodiments, the connector includes a closed part. In some embodiments, the connector includes a spline washer. In some embodiments, the connector includes an O-ring. In some embodiments, the connector includes an assembly line. In some embodiments, the connector includes an articulated part, which is configured to reduce the amount of bending of the rod to attach the spinal rod to the connector. In some embodiments, this configuration allows the connector to be used in conjunction with a multi-rod spinal structure having spinal rods with different profiles.

[0030] In some embodiments, the surgical system of the present invention includes a spinal structure including an inter-rod connector, which is used in conjunction with a method so that when a user locks a set screw to a spinal rod placed with a closed component, the spline washer is forced toward the spline on the open component. In some embodiments, this step also squeezes the O-ring and engages the spline to lock the closed component relative to the orientation of the open component while locking the spinal rod placed with the closed component in a selected orientation. In some embodiments, a separate set screw is then used to lock the spinal rod placed with the open component rod. In some embodiments, the connector may include an open component and / or a closed component, which can accommodate one or more spinal rod sizes and / or diameters. In some embodiments, the rod may not include a circular cross-section.

[0031] In some embodiments, the surgical system of the present invention includes a spinal structure including an inter-rod connector, and includes a method for assembling the connector. In some embodiments, the assembly method includes the following steps: driving or otherwise delivering an assembly wire through an assembly channel of a connector component. In some embodiments, the channel is formed by aligning an open component and a closed component. In some embodiments, the assembly wire is arranged with a connector to prevent and / or prevent the connector components from separating while allowing the components to rotate around a common axis. In some embodiments, the length and / or diameter of the wire is selected so that it is arranged with the components to provide a slidable relative rotation between the connector components. In some embodiments, the diameter of the wire is selected so that it does not occupy the entire space and / or diameter of the wire channel. In some embodiments, this configuration limits the tolerance and / or conversion between the connector components. In some embodiments, the length of the wire is selected so that when the wire is pushed completely through the entry channel of the connector component, such as the open component, and then enters the assembly channel, the wire forms a substantially C-shaped shape. In some embodiments, the wire is biased in the assembly channel to expand outward so that the wire only contacts the inner surface of the concave (female aspect) of the component that defines the assembly channel. In some embodiments, this configuration limits contact of the wire leading to the component with the concave surface of the mounting channel so as to effectively limit the amount of frictional engagement of the wire with the connector component during relative rotation of the components. In some embodiments, the C-shaped configuration of the wire and the location of the entry channel relative to the mounting channel eliminate additional assembly steps, such as staking, for maintaining the wire in the mounting channel. In some embodiments, the wire is positioned with the mounting channel such that the wire is positioned tangentially to an inner wall defining the mounting channel and is not positioned tangentially to an outer wall defining the mounting channel.

[0032] In some embodiments, the surgical system of the present invention comprises a spinal construct including a rod-to-rod connector having a silicone O-ring configured to maintain a spacing or gap between the splines of the washer and the splines of the open component until the closed component is finally tightened. In some embodiments, maintaining the spacing or gap between the splines allows the components to articulate. In some embodiments, locking the set screw of the closed component allows the spinal rod placed with the closed component to push the washer into the O-ring. The O-ring is squeezed so that the splines can engage.

[0033] In some embodiments, the connector includes a closure member having a spinal rod channel with a teardrop-shaped cross-sectional configuration. In some embodiments, the spinal rod channel has an inclined cross-section oriented toward the mating washer. In some embodiments, this configuration forms a larger opening for inserting the spinal rod. In some embodiments, this configuration includes an angle and positioning of the set screw relative to the lateral half of the spinal rod, which helps drive the rod down the slope of the spinal rod channel to push the washer, thereby locking the connector component in a selected appropriate position.

[0034] In some embodiments, the surgical system of the present invention comprises a spinal construct comprising a bone screw and a spinal rod connector. In some embodiments, the surgical system of the present invention comprises a spinal construct that can be used in conjunction with a method for treating the spine, the method comprising attaching an auxiliary rod to an existing spinal rod. In some embodiments, the surgical system of the present invention comprises a spinal construct that can be used in conjunction with a method for treating the spine, the method comprising repairing a broken rod. In some embodiments, a new rod can be installed into the connector to bridge the crack in the rod, no matter how close the existing pedicle screws are. In some embodiments, the surgical system of the present invention comprises a spinal construct that can be used in conjunction with a method for treating the spine, the method comprising connecting a second rod to the construct.

[0035] In some embodiments, the spinal structure includes a spline assembly that allows rotation, for example, in a coronal orientation, before the set screw is tightened, the rotation may include rod rotation, and allows staggered engagement to lock the spinal structure when the set screw is tightened. In some embodiments, the spinal structure includes a spline assembly that allows rotation, for example, in a sagittal orientation, before the set screw is tightened and staggered engagement when the set screw is tightened to lock the spinal structure, the rotation may include rod rotation. In some embodiments, the spinal structure includes a rod receiver with a fixed coronal angular offset. In some embodiments, the spinal structure includes a rod receiver with a fixed sagittal angular offset. In some embodiments, the spinal structure includes a revision connector that is configured to attach to one or more existing spinal structures implanted in the body. In some embodiments, the spinal structure can be used in revision surgery to extend an existing screw and rod structure. In some embodiments, the spinal structure can be used in revision surgery to connect an existing spinal structure and extend an existing spinal structure to span one or more spinal levels.

[0036] In some embodiments, the surgical system of the present invention comprises a spinal construct that can be used in revision surgery to connect to an existing rod implanted in the body. In some embodiments, the spinal construct and the existing spinal construct include an extension. In some embodiments, the surgical system of the present invention comprises a spinal construct that can be used in revision surgery to connect to an existing bone screw and rod construct by a minimally invasive method. In some embodiments, the surgical system of the present invention comprises a spinal construct having an adjustable rod geometry so that the rod is loaded onto the connector after the connector is delivered to the surgical site.

[0037] In some embodiments, one or all components of the surgical system may be disposable, peel-and-seal, pre-packaged sterile devices. One or all components of the system may be reusable. The system may be configured as a kit having multiple sized and configured components.

[0038] In some embodiments, the surgical system of the present invention can be used to treat spinal disorders, such as degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumors and fractures. In some embodiments, the surgical system of the present invention can be used in conjunction with other skeletons and bone-related applications, and the applications include those applications associated with diagnosis and therapy. In some embodiments, the disclosed surgical system can be used alternatively in surgical treatments in which the patient is in a prone or supine position, and / or various surgical approaches (including anterior, posterior, posterior midline, direct lateral, posterior lateral and / or anterolateral approaches) are used to reach the spine, as well as to reach other body regions. The surgical system of the present invention can also be used alternatively in conjunction with surgical procedures for treating the lumbar spine, cervical spine, thoracic spine, sacrum and pelvic regions of the spine. The surgical system of the present invention can also be used in animals, bone models and other non-biological matrices, such as in training, testing and demonstrations.

[0039] The surgical system of the present disclosure can be more easily understood by the following detailed description of the embodiments with reference to the accompanying drawings that form a part 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 shown herein, and the terms used herein are only for the purpose of describing specific embodiments by example, and are not intended to be limiting. In some embodiments, as used in the specification and including the appended claims, unless the context clearly stipulates otherwise, the singular forms "a, an" and "the" include plural numbers, and references to specific numerical values ​​include at least the specific values. The range can be expressed herein as from "about" or "approximately" a specific value and / or to "about" or "approximately" another specific value. When expressing such a range, another embodiment includes from a specific value and / or to another specific value. Similarly, when a value is expressed as an approximation by using the antecedent "about", it should be understood that the specific value forms another embodiment. It should also be understood that all spatial references, such as horizontal, vertical, top, upper, lower, bottom, left and right, are for illustrative purposes only and can be changed within the scope of the present disclosure. For example, references to "upper" and "lower" are relative and are used only in the context of being relative to each other and not necessarily "higher" and "lower."

[0040] As used in the specification and including the appended claims, "treating" or "treatment" of a disease or condition refers to performing a procedure that may include administering one or more drugs to a patient (normal or abnormal human or other mammal), using an implantable device, and / or using an instrument for treating a disease (e.g., a microdiscectomy instrument for removing bulging or herniated discs and / or bone spurs) in an effort to alleviate the signs or symptoms of the disease or condition. Relief may occur before the onset of symptoms or symptoms of the disease or condition as well as after onset. Thus, treatment or treatment includes preventing or preventing a disease or undesirable condition (e.g., preventing the disease from occurring in a patient who may be susceptible to the disease but has not yet been diagnosed with the disease). In addition, treatment does not require complete relief of signs or symptoms, does not require a cure, and specifically includes procedures that have only a marginal effect on the patient. Treatment may include inhibiting the disease, such as curbing its development, or alleviating the disease, such as causing regression of the disease. For example, treatment may include reducing acute or chronic inflammation; relieving pain and reducing and inducing regrowth of new ligaments, bones, and other tissues; as an adjunct to surgery; and / or any repair procedure. In some embodiments, as used in the specification and including the appended claims, unless expressly mentioned otherwise, the term "tissue" includes soft tissue, ligaments, tendons, cartilage, and / or bone.

[0041] The following discussion contains descriptions of surgical systems including spinal constructs, related components, and methods of using the surgical systems according to the principles of the present disclosure. Alternative embodiments are disclosed. Reference is made to exemplary embodiments of the present disclosure illustrated in the accompanying drawings. Figure 1-13 , components of a surgical system, such as a spinal implant system 10, are shown.

[0042] The components of spinal implant system 10 can be made of biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics and bone materials and / or their composites. For example, the components of spinal implant system 10 can be made of, for example, stainless steel alloys, aluminum, industrial pure titanium, titanium alloys, grade 5 titanium, superelastic titanium alloys, cobalt-chromium alloys, superelastic metal alloys (for example, Nitinol, superelastic plastic metals, such as GUM ), ceramics and their composites (such as calcium phosphate (e.g., SKELITE TM), thermoplastics (such as polyaryletherketone (PAEK), including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composite, PEEK-BaSO4 polymer rubber, 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, poly vinyl, epoxy resin), bone materials (including autologous transplantation, allogeneic transplantation, xenograft or transgenic cortical bone and / or cortical spongy bone and tissue growth or differentiation factors), partially absorbable materials (e.g., composites of metal 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.

[0043] The various parts of spinal implant system 10 can have composite material, comprise above-mentioned material, to realize various required characteristics, such as intensity, rigidity, elasticity, compliance, biomechanical property, durability and radiolucency or imaging preference.The parts of spinal implant system 10 also can be made by heterogeneous material individually or jointly, for example, by the combination of two or more above-mentioned materials.As described herein, the parts of spinal implant system 10 can be integrally formed, integrally connected or comprise fastening element and / or instrument.

[0044] Spinal implant system 10 is used in conjunction with minimally invasive surgery, and described minimally invasive surgery comprises percutaneous technique, micro-open and open surgical technique, to deliver and introduce the parts of instrument and / or spinal structure at the surgical site in the patient, such as a segment of the spinal column.In certain embodiments, one or more parts in spinal implant system 10 are configured to engage with existing structure, and described existing structure can comprise fastener implant and / or spinal rod implant attached to vertebra, so that in revision surgery, manipulate tissue and / or correct spinal disease, as described herein.In certain embodiments, one or more parts of spinal implant system 10 can be used to connect existing spinal structure in revision surgery, and extend, overhaul or repair existing spinal structure to span one or more spinal levels.Spinal implant system 10 comprises spinal structure 11.In certain embodiments, one or more parts of spinal structure 11 are configured to extend existing spinal rod implant, and existing rod implant can be removed or not removed simultaneously.In certain embodiments, existing spinal structure can be included in one or more implants connected with tissue or fixed with tissue in previous or different surgical procedures, and the time and / or duration that they are carried out in the same surgical procedure are separated.

[0045] The spinal construct 11 includes a connector 12. The connector 12 is configured as a variable angle connector 12. In some embodiments, the connector 12 is a rod-to-rod connector having receivers that rotate independently of each other to facilitate connection between rods having different profiles and tissues such as vertebrae.

[0046] Connector 12 includes receiver 14 and receiver 114, as described herein. Receiver 14 includes a body 16 extending along axis X1. Receiver 14 includes a pair of spaced arms 18, 20 that define an implant cavity, such as a passageway 22. In some embodiments, passageway 22 is configured for placement of a spinal implant, such as spinal rod 200, to extend and / or revise an existing spinal structure, as described herein. Passageway 22 is configured for side loading of spinal rod 200. In some embodiments, passageway 22 can be positioned for alternative loading orientations, such as top, side, and / or transverse placement to axis X1. Arms 18, 20 each extend parallel to axis X1, such as Figure 3 In some embodiments, arms 18 and / or arms 20 may be disposed in alternative orientations relative to axis X1, such as transverse, perpendicular, and / or other angular orientations, such as acute or obtuse, coaxial, and / or may be offset or staggered.

[0047] In various embodiments, passageway 22 is generally U-shaped. In some embodiments, all or only a portion of passageway 22 may have alternative cross-sectional configurations, such as closed, V-shaped, W-shaped, oval, rectangular, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, and / or tapered configurations. Body 16 includes interior surface 24. A portion of surface 24 includes a thread form 26 that is positioned with arm 18. Thread form 26 is configured to engage with a coupling member, such as a set screw 202, to retain rod 200 within passageway 22, such as Fig.13 . In some embodiments, surface 24 can be arranged with a set screw in an alternative fixing configuration, such as a friction fit, a press fit, a locking protrusion / recess, a locking keyway, and / or an adhesive. In some embodiments, all or only a portion of surface 24 can have an alternative surface configuration to enhance engagement with a spinal rod and / or a set screw, such as a rough, arched, wavy, lattice-like, porous, semi-porous, recessed, and / or textured configuration. Set screw 202 is configured to engage with rod 200 so as to facilitate fixation and / or locking of rod 200 with receiver 14. Set screw 202 can be arranged with receiver 14 between an unlocked orientation and a locked orientation, wherein the unlocked orientation allows rod 200 to translate relative to connector 12, and the locked orientation allows set screw 202 to fix rod 200 with connector 12.

[0048] The body 16 includes a mating surface, such as a spline surface 30. The spline surface 30 is configured to form a spline connection 32 with a mating surface, such as a spline surface 134 of a washer 128 connected to or as part of the receiver 114, as described herein. The spline connection 32 is configured to facilitate incremental and selective positioning of a spinal implant, such as a spinal rod 204, relative to an existing spinal structure including the spinal rod 200 via relative movement of the corresponding spline surfaces 30, 134, and locking of the spinal rod 204 relative to the existing spinal structure via a grid engagement of the corresponding spline surfaces. The spline connection 32 can be moved between an unlocked and locked configuration via compression of an O-ring 136, as described herein, so as to selectively rotate the spinal rod 204 to a selected position relative to the existing spinal structure and / or tissue, as described herein.

[0049] The receiver 14 is connected to the receiver 114 by a flexible element, such as a wire 40, as described herein. The wire 40 is configured to be arranged with a passage, such as a fitting channel 54 formed by aligning the receivers 14, 114, as described herein, so as to connect the receivers 14, 114. The body 16 includes a surface 50 defining a cavity 51. The cavity 51 is configured to receive a portion of the body 116, as described herein, to facilitate the assembly of the connector 12. The surface 50 includes an outer peripheral surface 52 of the channel 54, as described herein. Fig. 9 Surface 150 includes an inner peripheral surface 152 of channel 54, such as Fig. 9 Surface 52 may be positioned to communicate and align with surface 152 to form channel 54 .

[0050] The body 16 includes a surface 60 defining an opening 62. The opening 62 is disposed in communication with the passage 54 such that the wire 40 is inserted through the opening 62 into the passage 54 to assemble the connector 12. The opening 62 extends transversely to the passage 54, as shown in FIG. Fig. 9 54, so that the opening 62 intersects the passage 54. In some embodiments, near the intersection of the opening 62 and the passage 54, the portion 60a of the surface 60 is tangentially aligned with the surface 152, and the portion 60b of the surface 60 is offset and not tangentially aligned with the surface 52. Thus, the surface 60b is connected to the surface 52 to form a protrusion 70. The protrusion 70 extends into the passage 54 for a certain distance to block and / or prevent the wire 40 from withdrawing from the passage 54. In some embodiments, this configuration eliminates the need for additional assembly steps, such as riveting, for maintaining the wire 40 in the passage 54. In some embodiments, the opening 62 extends in a vertical and / or other angular orientation, such as an acute angle or an obtuse angle, coaxial, and / or can be offset or staggered relative to the surface 52.

[0051] Line 40 extends between end 42 and end 44, as shown in FIG. Figure 5 Wire 40 is configured to be disposed with channel 54, as described herein, to facilitate connection of receivers 14, 114. Wire 40 comprises a length L and a diameter D. Wire 40 is configured to connect receiver 14 with receiver 114 while allowing relative rotation of receiver 14 and receiver 114 to selectively position spinal rods 200, 204. Length L and diameter D are selected to facilitate rotation between receiver 14 and receiver 114.

[0052] The length L of the wire 40 is selected so that when the wire 40 is driven or translated through the opening 62 of the connector 14 and then into the channel 54, the wire 40 forms a C-shape, such as Fig. 9 The diameter D of the wire 40 is selected so that the wire 40 can move and / or does not occupy the entire space and / or diameter of the channel 54, as shown in FIG. Fig. 9 and 10. The wire 40 is biased within the channel 54 to expand outwardly so that the wire 40 contacts the surface 52. In some embodiments, the wire 40 may expand within the channel 54 and contact only the surface 52. In some embodiments, the wire 40 may expand within the channel 54 and contact the surface 52 and / or the surface 152. For example, providing movement of the diameter D in the channel 54 and / or providing a space between the surface 52, 152 of the channel 54 and the diameter D reduces the friction between the wire 40 and the surface 52, 152, thereby facilitating slidable rotation between the receivers 14, 114. In some embodiments, this configuration of the wire 40 and the channel 54 limits the tolerance and / or conversion between the receivers 14, 114 and prevents the receivers 14, 114 from separating while allowing the receivers 14, 114 to rotate relative to each other about a common axis.

[0053] In some embodiments, all or only a portion of the wire 40 may have flexible properties, such as those corresponding to the material examples described above, such that the wire 40 provides selective expansion and / or extension in the axial direction. In some embodiments, all or only a portion of the wire 40 may have a semi-rigid, rigid, or elastic configuration, and / or have elastic properties, such as those corresponding to the material examples described above, such that the wire 40 provides selective expansion and / or extension in the axial direction. Whether or not it is the wire 40, the flexible element may be a spring in some embodiments, which has a generally straight state in which it is mounted through the opening 62. After being forced into a bent state by the outer surface 52 of the passage 54, the spring action of the element pushes the outer surface 52 outward as the element attempts to return to a straighter state.

[0054] In some embodiments, the line 40 has a flexible configuration that includes movement in a lateral or left-right direction. In some embodiments, the line 40 can be extruded in an axial direction. The line 40 can include multiple separately attached or connected parts or sections, such as bands or loops, or can be integrally formed as a single continuous element.

[0055] Wire 40 may have uniform thickness / diameter. In some embodiments, wire 40 may have various surface configurations, such as rough, threaded, arched, wavy, porous, semi-porous, recessed, polished and / or textured configurations for connection with surgical instruments. In some embodiments, the thickness defined by wire 40 may increase or decrease uniformly, or have alternating diameter sizes along its length. In some embodiments, wire 40 may have various cross-sectional configurations, such as elliptical, rectangular, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable and / or tapering configurations. In some embodiments, wire 40 may have various lengths. In some embodiments, wire 40 may be braided, such as a rope, or include a plurality of elongated elements to provide a predetermined force resistance. In some embodiments, wire 40 may be deformable, ductile or plastically deformable.

[0056] Receiver 114 includes body 116 defining wall 118. Wall 118 includes surface 120 that defines a closed implant cavity, such as passage 122. Passage 122 is configured for placement of spinal rod 204 to extend and / or revise an existing spinal structure, as described herein. Passage 122 is configured for front loading of spinal rod 204 along axis X2. In some embodiments, passage 122 can be positioned for alternative loading orientations, such as top, side, and / or lateral.

[0057] In various embodiments, the passage 122 is generally oval or teardrop shaped, such as Figure 4 In various embodiments, the passage 122 includes a bottom 123 that slopes toward the gasket 128 (see Fig.11 ). In various embodiments, the passage 122 including the bottom 123 and the opposite top is inclined toward the gasket 128, or has an inclined cross-section that is inclined toward the gasket 128, as described herein. In some embodiments, the bottom and / or the inclined cross-section includes a downwardly inclined and / or inclined portion defining an angle α, such as Figure 4 128, to facilitate pushing the spinal rod 204 toward the washer 128, including when a force is applied to the spinal rod 204 via the set screw 206 (e.g., see Fig.13 , 16 18). In some embodiments, this configuration forms a larger opening for inserting the spinal rod 204. In some embodiments, this configuration includes an angle and positioning of the set screw 206 relative to the lateral half of the spinal rod 204, which helps drive, guide and / or guide the spinal rod 204 toward the washer 128, thereby locking the connector 14, 114 in a selected appropriate position, as described herein. In some embodiments, the set screw 206 is disposed at an angle β relative to the axis X3 of the receiver 114, such as Fig.13In some embodiments, the set screw 206 may include a recessed or angled tip to facilitate engagement of the set screw 206 with the spinal rod 204 and push the spinal rod 204 toward the washer 128.

[0058] In some embodiments, all or only a portion of the passageway 122 may have alternative cross-sectional configurations, such as circular, U-shaped, V-shaped, W-shaped, rectangular, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered and / or tapered configurations.

[0059] The body 116 includes an inner surface 124. A portion of the surface 124 includes a thread form 126. The thread form 126 is configured to engage with a coupling member, such as a set screw 206, to retain the rod 204 within the passage 122, such as Fig.13 114. In some embodiments, the surface 124 can be arranged with the set screw 206 in an alternative fixing configuration, such as a friction fit, a press fit, a locking protrusion / recess, a locking keyway, and / or an adhesive. In some embodiments, all or only a portion of the surface 126 can have an alternative surface configuration to enhance engagement with the spinal rod 204 and / or the set screw 206, such as a rough, arched, wavy, grid-like, porous, semi-porous, recessed, and / or textured configuration. The set screw 206 is configured to engage with the rod 204 so as to facilitate fixation and / or locking of the spinal rod 204 with the receiver 114. The set screw 206 can be arranged with the receiver 114 between an unlocked orientation and a locked orientation, wherein the unlocked orientation allows the spinal rod 204 to translate relative to the connector 12, and the locked orientation allows the set screw to fix the rod 204 with the connector 12.

[0060] The body 116 can be connected to the washer 128. The washer 128 includes a circular configuration. The washer 128 includes an opening 129. The opening 129 is configured for receiving the post 148 of the body 116 so that the insertion of the spinal rod 204 causes the washer 128 to translate, thereby locking the receiver 114 with the receiver 14, as described herein.

[0061] The gasket 128 extends between the end 130 and the end 132. Figure 6 As shown. End 130 includes a spline surface 134. Spline surface 134 is configured to form a spline connection 32 with spline surface 30, as described herein. A biasing element, such as an O-ring 136, is disposed between surface 134 and surface 30. O-ring 136 is configured to apply a force to surfaces 134, 30 to bias surfaces 134, 30 in a spaced relationship, maintaining surfaces 134, 30 in an unlocked orientation to facilitate relative rotation of receivers 14, 114.

[0062] End 132 includes surface 140. In some embodiments, surface 140 is arcuate to facilitate engagement with spinal rod 204. For example, after spinal rod 204 is secured with receiver 114, as described herein and Fig.13 As shown in FIG. 1 , spinal rod 204 applies force to surface 140. The force applied to surface 140 by spinal rod 204 causes washer 128 to Fig.13 1. The translation of washer 128 causes surface 134 to compress O-ring 136 and overcome the biasing force of O-ring 136. The translation of surface 134 causes surface 134 to interlock with surface 30 into spline connection 32, thereby fixing the selected position of spinal rod 204 and spinal rod 202.

[0063] The post 148 is configured to be received by the opening 129 of the gasket 128, as shown in FIG. Figure 6 The column 148 is configured to be received by the cavity 51 of the body 16, as shown. Figure 5 and 7 . Post 148 includes a surface 152 disposed circumferentially around post 148. Surfaces 52, 152 are aligned to form channel 54 as described herein. For example, body 116 is assembled with body 16 so that post 148 is disposed with cavity 51. Post 148 is positioned with cavity 51 so that surfaces 52, 152 are aligned to form channel 54. Wire 40 is inserted into opening 62 and translated into channel 54 so that wire 40 is disposed circumferentially around post 148, as described herein. Fig. 9 . The wire 40 is expandable between a contracted orientation for insertion and a relatively fixed expanded orientation for the receiver 14, 114, and is elastic. After the wire 40 is inserted, the wire 40 expands outwardly, as described herein and Fig.10 Wire 40 connects the receiver 114 with the receiver 14 to assemble the connector 12, as shown in FIG. Fig.11 and 12 as shown in .

[0064] In certain embodiments, spinal implant system 10 can comprise one or more connectors 12, such as those described herein, and they can be used in conjunction with single vertebral level or multiple vertebral levels.In certain embodiments, one or more connectors 12 can engage with vertebra with various orientations, such as continuous, parallel, offset, staggered and / or alternate vertebral levels.In certain embodiments, one or more connectors 12 can be used in conjunction with: multiaxial screw, sagittal angle screw, pedicle screw, uniaxial screw, uniplane screw, set screw, anchor, hook, tissue penetration screw, conventional screw, expansion screw, wedge, anchor, button, clip, buckle, friction fitting, compression fitting, expansion rivet, staple, nail, adhesive, post, connector, fixation plate and / or fixed post.

[0065] In assembly, operation and use, a spinal implant system 10 similar to the system and method described herein is used in conjunction with an operating procedure, such as an applicable condition or injured surgical treatment to the affected section of the spine and adjacent areas in the body. In certain embodiments, the spinal implant system 10 comprises a connector 12, as described herein, and the connector is attached to the vertebral tissue treated. In certain embodiments, the spinal implant system 10 comprises a connector 12, as described herein, and the connector can be used to strengthen, renovate, repair and / or extend existing spinal structure in the surgical treatment of, for example, revision surgery. In certain embodiments, the spinal implant system 10 is included in a connector 12 for being connected with existing spinal structure and strengthening existing spinal structure to span one or more spinal levels in revision surgery. In certain embodiments, existing spinal structure may be included in one or more implants connected to tissue or fixed with tissue in previous or different surgical procedures, and the time and / or duration they carry out in the same surgical procedure are separated. In certain embodiments, during surgical treatment, the spinal implant system 10 can be completely or partially renovated, removed or replaced.

[0066] For example, the surgical treatment may include increasing the strength and support of an existing spinal construct 290 that includes fasteners 300 and an existing spinal rod implant 200 that were implanted into vertebrae V during a previous surgical procedure, such as Fig.14 In a previous surgical procedure, an existing spinal rod implant 200 was implanted to structurally fuse adjacent vertebrae V1, V2, V3, V4 with an existing spinal construct 290 including fasteners 300 and an existing spinal rod implant 200 to span intervertebral discs D1, D2, D3. In one example, the surgical procedure required the use of multiple rods, such as the existing spinal rod implant 200 and rod 204, as shown. Fig.15 as shown in .

[0067] In some embodiments, multiple rods are required for high load demands, such as transpedicular osteotomy, lumbar fixation, critically ill patients, and / or revision surgery after or different from a previous surgical procedure. In some embodiments, the treatment includes a connector 12 for connection with a spinal rod 200 in a revision surgery to form a revised spinal construct 290R that reinforces the spinal construct 290 along spinal levels V1-V4, as described herein. In some embodiments, this configuration avoids destruction and tissue damage in the area of ​​the previous surgical procedure and shortens the healing and treatment time.

[0068] In conjunction with the surgical procedure, to treat the selected segment of vertebra V, including vertebra V1, V2, V3, V4, the medical practitioner obtains access to the surgical site including vertebra V in any appropriate manner, such as by cutting and retracting tissue. In some embodiments, the spinal implant system 10 can be used in any existing surgical method or technology, including open surgery, mini-open surgery, minimally invasive surgery, and percutaneous surgery, whereby vertebra V can be accessed through a micro-incision or a cannula that provides protected access to the area. Once the surgical site is entered, a specific surgical procedure can be performed to treat the spinal condition.

[0069] An incision is made in the patient, and a cutting instrument (not shown) forms a surgical path to access the existing spinal structure 290, including implanted fasteners 300 and implanted existing spinal rod implants 200. The surgical path is used to implant the components of the spinal implant system 10. A preparation instrument (not shown) can be used to prepare the tissue surface of the vertebra V and also to aspirate and irrigate the surgical area.

[0070] Before the surgical procedure, for example, during the manufacture of the components of spinal implant system 10 or in the operating room or in the field, the connector 12 is assembled, as described herein. The connector 12 is placed adjacent to the existing spinal structure 290 to engage with the spinal rod 200. The spinal rod 200 is placed with passage 22. The spinal rod 200 is fixed with the receiver 14 via the set screw 202. The set screw 202 is engaged with the surgical instrument of, for example, a driver (not shown), and the surgical instrument advances the set screw 202 to engage with the threaded form 26 of the receiver 14, so as to be placed with the spinal rod 200 in a locked orientation, as described herein. In certain embodiments, the driver can engage the set screw 202 to temporarily fix the spinal rod 200 with the receiver 14, thereby promoting the placement of the spinal rod 204 with the receiver 114.

[0071] The spinal rod 204 is delivered along the surgical path and is placed within the passage 122. In some embodiments, the spinal rods 200, 204 are selectively manipulated and / or contoured for surgical treatment and / or to accommodate differences in body structure. The O-ring 136 maintains the surfaces 30, 134 in an unlocked orientation so that the receivers 14, 114 rotate relative to and / or independently to facilitate positioning of the spinal rods 200, 204 relative to components of the spinal structure 290. In the case where the spinal rod 200 is placed with the receiver 14, the receivers 14, 114 can rotate relative to and / or independently, and / or the spinal rod 200 can be moved relative to the connector 12 to place the spinal rod 204 with the receiver 114. The spinal rod 204 is fixed with the receiver 114 via a set screw 206. The set screw 206 is engaged with a surgical instrument, such as a driver (not shown), which advances the set screw 206 to engage the thread form 126 of the receiver 114 in a locked orientation, as described herein. The driver engages the set screw 206 to secure the spinal rod 204 with the receiver 114 and attach the spinal rod 204 to the vertebra V.

[0072] When the set screw 206 is advanced into engagement with the spinal rod 204, the spinal rod 204 applies a force to the surface 140. The force applied to the surface 140 by the spinal rod 204 causes the washer 128 to move in a direction opposite to the spinal rod 204. Fig.13 1. The O-ring 136 is compressed by the washer 128, thereby overcoming the biasing force of the O-ring 136. The surface 134 interlocks with the surface 30 to form a spline connection 32, thereby fixing the relative orientation of the receivers 14, 114 and the selected position of the spinal rods 204, 200.

[0073] Connector 12 and spinal rod 204 are manipulated to place spinal rod 204 in the position of supporting and strengthening the existing spinal structure that has included spinal rod 200, thereby forming spinal structure 290R after revision. Spinal structure 290R strengthens existing spinal structure 290 along vertebra V1-V4 after revision, and can not make existing spinal structure 290 rupture. Spinal structure 290R is configured to fuse adjacent vertebra V1-V4 on structure. In certain embodiments, spinal rod 204 is configured to increase support and the strength of spinal implant system 10 along vertebra V. In certain embodiments, spinal structure 290R can be adjusted to selectively span one or more vertebrae.

[0074] In some embodiments, the receiver 14, 114 is configured to accommodate a series of spinal rods. In some embodiments, the receiver 14, 114 is configured to accommodate a spinal rod having a diameter of 5.5 mm, such as Fig.13 In some embodiments, the receiver 14, 114 is configured to accommodate a spinal rod having a diameter of 6.0 mm, such as Fig.16 and 17In some embodiments, the receiver 14, 114 is configured to accommodate a spinal rod having a diameter of 6.3 mm, such as Fig.18 and 19 . In some embodiments, receiver 14, 114 is configured to accommodate spinal rods with diameters in the range of 5.5mm to 6.3mm. In some embodiments, receiver 14, 114 is configured to accommodate spinal rods with various cross-sections, such as shaped, oval, rectangular, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered and / or gradually narrowing cross-sections. In some embodiments, the size of positioning screw 206 is configured to adapt to spinal rods of various sizes. For example, after locking the spinal rod, a smaller spinal rod will leave more threads above the spinal rod. In some embodiments, a larger spinal rod will leave fewer threads above the spinal rod. Thus, positioning screw 206 is appropriately configured to apply enough thrust to the spinal rod after positioning screw 206 is fully inserted so as to promote engagement to maintain stability.

[0075] After finishing procedure, just can remove the surgical instrument, assembly and the non-implantation parts of spinal implant system 10 from the surgical site, and close incision.One or more parts of spinal implant system 10 can be made of the radiolucent material of for example polymer.Can comprise radioactive marker, be used for identifying under x-ray, perspective, CT or other imaging technology.In certain embodiments, the use of surgical navigation, robotics, microsurgery and image-guided technology can be used to approach, check and repair spinal column deterioration or damage by means of spinal implant system 10.

[0076] In certain embodiments, spinal implant system 10 comprises reagent, and described reagent can be placed, encapsulated, coated or layered in parts and / or the surface of spinal implant system 10, on or around.In certain embodiments, reagent can comprise bone growth promoting material, for example bone graft, to strengthen the fixation of bone fastener with respect to vertebra.In certain embodiments, reagent can comprise one or more therapeutic agents and / or medicaments that are used to release (comprising sustained release) to treat for example pain, inflammation and degeneration.

[0077] It should be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be interpreted as limiting, but merely as an example of various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims attached hereto.

Claims

1. A connector, comprising: a first receiver defining an implant cavity and comprising a mating surface; a second receiver attachable to the first receiver via a flexible element, the second receiver defining an implant cavity and including a mating surface engageable with the mating surface of the first receiver to fix the relative orientation of the receivers; as well as a biasing element disposed adjacent the mating surface to space the mating surfaces apart so that, in operation of the connector, the first receiver is movable relative to the second receiver; wherein the receivers are connected to define a passage for positioning the flexible element, and one of the first receiver and the second receiver includes a surface defining an opening, the opening being positioned to communicate with the passage so that the flexible element can be inserted into the passage through the opening.

2. The connector of claim 1, wherein the implant cavity of the first receiver is configured for placement of a first spinal rod, and the implant cavity of the second receiver is configured for placement of a second spinal rod.

3. The connector of claim 1, wherein the receiver is positionable between an unlocked orientation in which the biasing element spaces the mating surfaces apart and a locked orientation in which the mating surfaces are fixed relative to each other to selectively orient the first receiver relative to the second receiver. The connector of claim 1 , wherein the biasing element comprises a flexible O-ring. The connector of claim 1 , wherein the mating surface comprises splines.

6. The connector of claim 1, wherein the mating surface of the second receiver comprises a splined surface of a washer disposed with the second receiver.

7. The connector of claim 6, wherein the washer is movable relative to the second receiver to engage the splined surface with the splined surface of the first receiver.

8. The connector of claim 1, wherein the flexible element is expandable within the passageway.

9. The connector of claim 1, wherein the flexible element is configured to be biased outwardly to expand in the passageway.

10. The connector of claim 1, wherein the first receptacle defines an opening in communication with the passageway.

11. The connector of claim 1, wherein the first receiver includes an outer peripheral surface and the second receiver includes an inner peripheral surface, the surfaces defining the passageway.

12. The connector according to claim 11, wherein the outer peripheral surface comprises a protrusion for stopping and / or preventing the flexible element from exiting from the passage.

13. The connector of claim 1, wherein the implant cavity of the second receiver comprises an inclined cross-section.

14. The connector of claim 1, wherein a bottom of the second receiver is angled toward a washer of the second receiver to drive a second spinal rod into engagement with the washer.

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