Spinal implant system and method

Abstract

To provide a spinal implant system and method for treating a spine.SOLUTION: A delivery system 30 includes a first instrument 32 having an outer sleeve 34 defining a passageway. The first instrument includes an inner sleeve 44 having a first end disposed in the passageway and a second end including a first mating element. The inner sleeve defines a channel. A second instrument includes a hollow shaft disposed in the channel, and a handle 116 coupled to the shaft. The handle includes a body, and a second mating element extending from the body. The second mating element is configured to engage the first mating element to secure the second instrument to the first instrument.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to medical devices for the treatment of musculoskeletal disorders, and more particularly to spinal implant systems and methods for treating the spine. [Background technology]

[0002] Spinal pathologies and disorders, such as scoliosis, kyphosis and other curvature abnormalities, degenerative disc disease, herniated discs, osteoporosis, spondylolisthesis, stenosis, tumors, and fractures, can result from factors including trauma, disease, and degenerative conditions due to injury or aging. Spinal disorders typically 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 can be effective, but may not alleviate 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 structures such as vertebral rods are often used to provide stability to the treated area. The rods redirect stress away from the damaged or defective area while healing occurs to restore proper alignment and generally support the vertebral members. During the surgical treatment, one or more rods and bone fasteners can be delivered to the surgical site. The rods may be attached to the outside of two or more vertebral members via bone fasteners. The surgeon can help support and stabilize the damaged vertebrae by using a driver to insert bone fasteners into the damaged vertebral body and attach the fasteners to one or more rods. It can sometimes be difficult for the surgeon to achieve the necessary support and stabilization of the damaged vertebral body because the threads of the bone fasteners do not properly engage the vertebrae. Thus, a surgeon can insert the bone filler device into a driver and use an injection gun coupled to the bone filler device to deliver adhesive or cement material into and / or around at least one of the bone fasteners to further bond the bone and at least one of the fasteners. However, the injection gun often creates a back pressure that causes the bone filler device to separate from the driver. As a result, a separate instrument is required to prevent the bone filler device from disconnecting from the driver when the injection gun creates a back pressure. Another common method of cement injection holds the bone filler device in place using one hand to act as a resistance against the back pressure. A plunger is used with the other hand to dispense the cement. The present disclosure describes improvements over these prior art techniques. Summary of the Invention

[0004] In one embodiment, a delivery system is provided. The delivery system includes a first instrument and a second instrument. The first instrument includes an outer sleeve defining a passageway. The first instrument includes an inner sleeve having a first end disposed within the passageway and a second end including a first mating element. The inner sleeve defines a channel. The second instrument includes a hollow shaft disposed within the channel and a handle coupled to the shaft. The handle includes a body and a second mating element extending from the body. The second mating element is configured to engage the first mating element to secure the second instrument to the first instrument. In some embodiments, a method is disclosed.

[0005] In one embodiment, a delivery system is provided. The delivery system includes an implant, a first instrument, and a second instrument. The implant includes a threaded screw and a head coupled to the screw. The screw includes a bore extending through opposing ends of the screw. The head has a threaded inner surface. The first instrument includes an outer sleeve defining a passageway. The first instrument includes an outer sleeve defining a passageway. The instrument includes an inner sleeve having a first end rotatably disposed within the passageway and a second end including a first mating element. The first end includes a threaded outer surface that engages the threaded inner surface to couple the inner sleeve to the head. The first end includes a tip disposed in the bore to couple the inner sleeve to the screw. The inner sleeve defines a channel. The second instrument includes a hollow shaft disposed within the channel and a handle coupled to the shaft. The handle includes a body and a second mating element extending from the body. The second mating element engages the first mating element to secure the second instrument to the first instrument, thereby preventing the second instrument from translating proximally relative to the first instrument.

[0006] In one embodiment, a delivery system is provided. The delivery system includes a bone fastener, a driver, a bone filler device, and an injector. The bone fastener includes a threaded screw and a head coupled to the screw. The screw is rotatable relative to the head in a plurality of planes. The screw includes an inner surface defining a bore extending through opposing ends of the screw. The screw includes an opening extending through an inner surface and an opposing outer surface of the screw. The head has a threaded inner surface. The driver includes an outer sleeve defining a passage. The driver includes an inner sleeve having a first end rotatably disposed within the passage and a second end including a flange. The first end includes a threaded outer surface that engages the threaded inner surface to couple the inner sleeve to the head. The first end includes a tip disposed in the bore for coupling the inner sleeve to the screw. The inner sleeve defines a channel. The bone filler device includes a hollow shaft disposed within the channel and a handle coupled to the shaft. The handle includes a body including a barrel coaxial with the shaft. The barrel has a threaded outer surface and an inner surface defining an opening in communication with and coaxial with the lumen of the shaft. The handle includes a first wing extending from a first side of the body in a cantilever configuration and a second wing extending from an opposing second side of the body in a cantilever configuration. The first wing includes an extension extending from the first side and a tab extending from the extension. The second wing includes an extension extending from the second side and a tab extending from the extension of the second wing. Each of the extensions extends parallel to a longitudinal axis defined by the shaft and each of the tabs extends perpendicular to the longitudinal axis. The tabs engage the flanges to secure the bone filler device to the driver, thereby preventing the bone filler device from moving proximally relative to the driver. An injector is coupled to the handle and includes bone cement therein. The injector is configured to deliver bone cement through the channel and into the hole. [Brief description of the drawings]

[0007] The present disclosure will become more readily apparent from the following specific description taken in conjunction with the drawings.

[0008] [Figure 1] FIG. 1 is a side view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure.

[0009] [Diagram 2] 2 is a side view of one embodiment of the components of the surgical system shown in FIG. 1 in accordance with the principles of the present disclosure.

[0010] [Diagram 3] FIG. 3 is a side cross-sectional view of the component shown in FIG. 2.

[0011] [Figure 4] FIG. 3 is an enlarged view of some of the components of FIG. 2.

[0012] [Diagram 5] FIG. 3 is an enlarged cross-sectional side view of a portion of the component shown in FIG. 2.

[0013] [Figure 6] 2 is a side view of one embodiment of the components of the surgical system shown in FIG. 1 in accordance with the principles of the present disclosure.

[0014] [Figure 7] FIG. 7 is a side cross-sectional view of the component shown in FIG.

[0015] [Figure 8] FIG. 7 is an enlarged view of some of the components of FIG. 6.

[0016] [Figure 9] FIG. 2 is an enlarged side view of some of the components of the surgical system shown in FIG. 1, with the components in an unassembled configuration.

[0017] [Figure 10] 2 is an enlarged cross-sectional side view of some of the components of the surgical system shown in FIG. 1, with the components in an unassembled configuration.

[0018] [Figure 11]2 is an enlarged cross-sectional side view of a portion of the surgical system shown in FIG. 1, with the components in an unassembled configuration.

[0019] [Figure 12] FIG. 2 is an enlarged side view of some of the components of the surgical system shown in FIG. 1, with the components in an assembled configuration.

[0020] [Figure 13] 2 is an enlarged cross-sectional side view of some of the components of the surgical system shown in FIG. 1, with the components in an assembled configuration.

[0021] [Figure 14] 2 is a top view of one embodiment of the surgical system shown in FIG. 1 in accordance with the principles of the present disclosure.

[0022] [Figure 15] 2 is a top view of one embodiment of the surgical system shown in FIG. 1 in accordance with the principles of the present disclosure.

[0023] [Figure 16] 2 is a top view of one embodiment of the surgical system shown in FIG. 1 in accordance with the principles of the present disclosure.

[0024] [Figure 17] FIG. 1 is a side view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure.

[0025] [Figure 18] 18 is a side view of one embodiment of the components of the surgical system shown in FIG. 17, in accordance with the principles of the present disclosure.

[0026] [Figure 19] FIG. 19 is a side cross-sectional view of the component shown in FIG.

[0027] [Figure 20] FIG. 19 is an enlarged view of some of the components of FIG.

[0028] [Figure 21] FIG. 19 is an enlarged cross-sectional side view of a portion of the component shown in FIG. 18. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] Exemplary embodiments of the disclosed surgical systems and associated methods of use are discussed with respect to medical devices for the treatment of musculoskeletal disorders, and more specifically, delivery systems and methods for treating the spine. In some embodiments, the disclosed systems and methods include medical devices, including surgical instruments and implants, for use in conjunction with surgical treatment in, for example, the cervical, thoracic, lumbar, and / or sacral regions of the spine.

[0030] Cement delivery guns create back pressure when used in conjunction with predictable bone filler devices. Current fenestrated screw systems rely on extra instruments to counteract the back pressure created by the cement delivery system gun. On the other hand, in various embodiments, the delivery system of the present disclosure The system simplifies the procedure by removing unnecessary steps while still providing the required functionality. In some embodiments, the delivery system includes a handle with a specific shape developed to eliminate the need for a separate instrument to secure the bone filler device to its guide / driver and to maintain a proper connection between the handle and the guide / driver during cement application. In some embodiments, the handle includes wings with a shape that allows for easy attachment to the undercut in the guide / driver. The handle also provides an ergonomic feature that allows for a simple release of the bone filler device from the guide / driver. In some embodiments, the distal end of the handle has a conical shape that helps to promote adaxialization of the bone filler device by aligning the handle with the guide / driver to ensure proper assembly of the handle and the guide / driver. In some embodiments, the handle and / or guide / driver generate a clicking sound during assembly of the handle and the guide / driver to indicate that the handle has been properly assembled with the guide / driver.

[0031] In some embodiments, the delivery system of the present disclosure may be used to treat spinal disorders such as, for example, degenerative disc disease, herniated discs, osteoporosis, spondylolisthesis, stenosis, scoliosis, kyphosis and other curvature abnormalities, tumors and fractures. In some embodiments, the delivery system of the present disclosure may be used for other skeletal or bone-related applications, including diagnostic and therapeutic related applications. In some embodiments, the disclosed delivery system may alternatively be used for surgical treatment with the patient in prone or supine position, and / or using various surgical approaches to the spine, including anterior, posterior, posterior midline, lateral, posterior lateral and / or anterior lateral approaches, and other body regions. The delivery system of the present disclosure may also alternatively be used in procedures to treat the lumbar, cervical, thoracic, sacral and pelvic regions of the spine. The delivery systems of the present disclosure may also be used in animals, bone models and other non-living substrates, such as for training, testing and demonstrations.

[0032] The delivery system of the present disclosure may be more readily understood by reference to the following detailed description of the embodiments in conjunction with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that the present application is not limited to the specific devices, methods, conditions, or parameters described and / or illustrated herein, and that the terms used herein are intended to describe specific embodiments by way of example only, and are not intended to be limiting. In some embodiments, the singular forms "a," "an," and "the," as used in the specification, including the appended claims, include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as ranging from "about" or "approximately" one particular value and / or to "about" or "approximately" another particular value. When such a range is expressed, another embodiment includes the range from one particular value and / or to the other particular value. Similarly, when values ​​are expressed as approximations, by use of the preposition "about," it will be understood that the particular value also forms another embodiment. Additionally, all spatial references, e.g., horizontal, vertical, top, upper, lower, bottom, left and right, etc., are for illustrative purposes only and will be understood to be variable within the scope of this disclosure. For example, the references "upper" and "lower" are relative and are used only in the context of one another and not necessarily "superior" and "lower."

[0033] As used herein, including the appended claims, "administering treatment" or "treating" a disease or condition refers to administering one or more drugs to a patient (usually a human or other mammal), using an implantable device, and / or using instruments to treat a disease, such as a microsurgical spinal cord implant used to remove a bulging or herniated disc and / or bone spurs, for the purpose of alleviating the signs or symptoms of the disease or condition. and using instruments such as microdiscectomy instruments. The term "treatment" refers to administering a treatment to a patient. Relief may occur before or even after signs or symptoms of a disease or condition are manifested. Thus, administering a treatment or treatment includes preventing or preventing a disease or undesirable condition (e.g., preventing a disease from developing in a patient who may be susceptible to the disease but has not yet been diagnosed with the disease). Furthermore, administering a treatment or treatment does not require complete relief or cure of the signs or symptoms, and specifically includes procedures that have only a minimal effect on the patient. Treatment may include inhibiting a disease, e.g., halting its progression, or alleviating a disease, e.g., causing the disease to regress. For example, treatment may include reducing acute or chronic inflammation, relieving and alleviating pain, inducing the regeneration of new ligaments, bone and other tissues, assisting with surgery, and / or any restorative procedures. As used in the specification, including the appended claims, the term "tissue" includes soft tissue, ligament, tendon, cartilage, and / or bone, unless otherwise specified.

[0034] The following discussion includes a description of a delivery system and methods of using the delivery system in accordance with the principles of the present disclosure. Alternative embodiments are also disclosed. Reference will now be made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying drawings. Turning to Figures 1-21, components of a delivery system, such as delivery system 30, are shown.

[0035] The components of the delivery system 30 may be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics, and bone materials, and / or composites thereof. For example, the components of the delivery system 30 may be fabricated, individually or collectively, from stainless steel alloys, aluminum, commercially pure titanium, titanium alloys, grade 5 titanium, superelastic titanium alloys, cobalt-chromium alloys, superelastic metal alloys (e.g., Nitinol, super elastoplastic metals such as GUM METAL®, etc.), and / or composites thereof. metal), ceramics and composites thereof such as calcium phosphates (e.g., SKELITE™), thermoplastics such as polyaryletherketones (PAEK), including polyetheretherketones (PEEK), polyetherketoneketones (PEKK) and polyetherketones (PEK), carbon-PEEK composites, PEEK-BaSO4, polymeric rubbers, polyethylene terephthalate (PET), fibers, silicones, polyurethanes, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylenes, polyamides, polyimides, polyetherimides, polyethylene, epoxies, autografts, allografts, xenografts or genetically engineered cortical and / or corticocancellous bone. The implant may be fabricated from bone materials, including fibroblasts, osteoarthritis bone, and tissue growth or differentiation factors, partially resorbable materials, such as composites of metals and calcium-based ceramics, composites of PEEK and calcium-based ceramics, composites of PEEK and resorbable polymers, fully resorbable materials, such as calcium-based ceramics, such as tricalcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymers, such as polyethide, polyglycolide, polytyrosine carbonate, polycaprolactone, and combinations thereof.

[0036] The various components of the delivery system 30 can have material composites including the materials listed above to achieve various desired properties, such as strength, stiffness, elasticity, conformability, biomechanical performance, durability, and radiolucency or imaging performance. The components of the delivery system 30, individually or collectively, may be fabricated from heterogeneous materials, such as combinations of two or more of the materials described above. The components of the delivery system 30 may be monolithically formed, integrally connected, or formed with fastening elements and / or fastening devices, as described herein. may include.

[0037] The delivery system 30 may be used, for example, in conjunction with fully open surgical procedures, minimally invasive procedures including percutaneous techniques, and small incision surgeries to deliver and introduce instruments and / or spinal implants, such as bone fasteners, at a patient's surgical site, including, for example, the spine. In some embodiments, the spinal implants may include one or more components of one or more spinal structures, such as, for example, interbody devices, interbody cages, bone fasteners, spinal rods, tethers, connectors, plates, and / or bone grafts, and may be used in conjunction with a variety of surgical procedures, including surgical treatment of the cervical, thoracic, lumbar, and / or sacral regions.

[0038] The delivery system 30 includes a first instrument, such as, for example, a driver 32. The driver 32 includes, for example, an outer sleeve 34 extending along a longitudinal axis L1 between an end 36 and an opposing end 38. The sleeve 34 has an inner surface 40 that defines a passageway 42, as best shown in FIG. 3. The passageway 42 is coaxial with the axis L1 and extends the entire length of the sleeve 34 such that the passageway 42 extends through opposing end faces of the ends 36, 38. In some embodiments, the passageway 42 has a circular diameter. In some embodiments, the passageway 42 has a uniform diameter along the entire length of the passageway 42. In some embodiments, the passageway 42 may be disposed coaxially, e.g., transversely, perpendicularly, and / or in other angled orientations, e.g., acute or obtuse angles, and / or may be offset or staggered, relative to the axis L1. In some embodiments, the passages 42 may have various cross-sectional configurations, such as, for example, elliptical, oval, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable, tubular, and / or tapered.

[0039] The driver 32 includes a sleeve, such as an inner sleeve 44, rotatably disposed within the passage 42 such that the sleeve 44 is coaxial with the axis L1. The sleeve 44 extends between an end 46 and an opposing end 48 disposed within the passage 42. The end 46 includes a first mating element, such as a flange 50, spaced from the flange 52 by an undercut, such as a recess 54. The flange 50 includes opposing faces 56, 58, each extending perpendicular to the axis L1, and surfaces 60, 62, respectively, disposed between the surfaces 56, 58, as best shown in FIGS. 4 and 5. The surface 56 defines an end face of the end 46. The surface 60 extends transversely to the axis L1, and the surface 62 extends parallel to the axis L1.

[0040] The sleeve 44 includes a body 64 having an inner surface 66 that defines a channel 68, as best shown in FIG. 3. The channel 68 is coaxial with the axis L1 and extends the entire length of the sleeve 44 such that the channel 68 extends through the surface 56 and the opposing end face of the end 48. In some embodiments, the channel 68 has a circular diameter. In some embodiments, the channel 68 has a uniform diameter along the entire length of the channel 68. In some embodiments, the channel 68 may be disposed coaxially, e.g., transverse, perpendicular, and / or in other angled orientations, e.g., acute or obtuse, and / or offset or staggered, relative to the axis L1. In some embodiments, the channel 68 may have various cross-sectional configurations, e.g., elliptical, oval, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable, tubular, and / or tapered.

[0041] End 48 includes a tip 70 that is connected to body 64, as best shown in FIG. 3. In some embodiments, tip 70 is removably connected to body 64 such that tip 70 is disposable. In such embodiments, tip 70 may be pre-fixed to body 64 such that rotation of body 64 also rotates tip 70. In some embodiments, tip 70 is variously connected to body 64, such as, for example, frictional engagement, threaded engagement, reciprocating grooves, threads, adhesives, prongs, barbs, and / or raised elements. In some embodiments, tip 70 is integrally and / or monolithically formed with body 64, and body 64 and / or tip are integrally and / or monolithically formed. The tip 70 cannot be removed from the body 64 without fracturing the tip 70. The tip 70 extends between an end 72 and an opposing end 74. The tip 70 includes an inner surface 76 that is coaxial with an axis L1 and defines a bore 78 that extends the entire length of the tip 70, with the bore 78 extending through the opposing end faces of the ends 72, 74. In some embodiments, the bore 78 has a circular diameter. In some embodiments, the bore 78 has a uniform diameter along the entire length of the bore 78. In some embodiments, the bore 78 may be disposed coaxially, e.g., transverse, perpendicular, and / or in other angled orientations, e.g., acute or obtuse, relative to the axis L1, and / or may be offset or staggered. In some embodiments, the bore 78 may have various cross-sectional configurations, e.g., elliptical, oval, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable, tubular, and / or tapered. End 72 is disposed within channel 68 such that bore 78 is in communication with and coaxial with channel 68. End 74 defines a drive portion configured to engage an implant, such as, for example, a bone fastener 80, as described herein. In some embodiments, drive portion may include a square, triangular, polygonal, star, or hexalobe cross-sectional configuration configured to engage a correspondingly shaped portion of fastener 80. In some embodiments, tip 70 includes a threaded outer surface configured to engage threads of fastener 80 to couple sleeve 44 to fastener 80, as described herein.

[0042] The fastener 80 includes an implant receiver 84 and a head, such as, for example, a threaded shaft 86, coupled to the receiver 84. The implant receiver 84 extends parallel to an axis L1 when the fastener 80 is coupled to the sleeve 44. The implant receiver 84 includes a pair of spaced apart arms 88, 90 that define an implant cavity 92 therebetween configured to dispose of a spinal structure, such as, for example, a spinal rod. Each of the arms 88, 90 extends parallel to the axis L1 when the fastener 80 is coupled to the sleeve 44. In some embodiments, the arms 88 and / or 90 may be disposed, for example, transverse, perpendicular, and / or in other angled orientations, such as, for example, acute or obtuse angles, coaxially, and / or offset or staggered relative to the axis L1. Each of the arms 88, 90 includes an arcuate outer surface extending between a pair of side surfaces. At least one of the exterior and side surfaces of the arms 88, 90 has at least one recess or cavity configured to receive an insertion tool, compression instrument, and / or instrument for inserting and tensioning the bone fastener 80.

[0043] Arm 88 includes a frangible tab 94 frangibly connected to arm 88 (FIG. 3), such that manipulation of tab 94 relative to arm 88 can frangibly and separate tab 94 from arm 88 at a predetermined force and / or torque limit, as described herein. In some embodiments, as force and / or torque is applied to tab 94 and resistance increases, e.g., as the predetermined torque and force limit is approached. Arm 90 includes a frangible tab 96 frangibly connected to arm 90, such that manipulation of tab 96 relative to arm 90 can frangibly and separate tab 96 from arm 90 at a predetermined force and / or torque limit, as described herein. In some embodiments, as force and / or torque is applied to tab 96 and resistance increases, e.g., as the predetermined torque and force limit is approached.

[0044] In some embodiments, the tabs 94, 96 can be fractured and separated at a predetermined force or torque limit, which can range from about 2 Newton meters (Nm) to 8 Nm. In some embodiments, the tabs 94, 96 and the arms 88, 90 can have the same or alternative cross-sectional configurations, can be made from a homogenous material or can be heterogeneously made from different materials, and / or alternatively formed from materials having a greater degree, characteristics or attributes of plastic deformability, brittleness, and / or fracture qualities to facilitate fracture and separation of the tabs 94, 96 from the arms 88, 90.

[0045] The cavity 92 is substantially U-shaped. In some embodiments, all or only a portion of the cavity 92 may have an alternative cross-sectional configuration, such as, for example, closed, V-shaped, W-shaped, elliptical, oval triangular, square, polygonal, irregular, uniform, non-uniform, offset, offset, and / or tapered. The implant receiver 84 includes a thread form configured to engage with a coupling member, such as, for example, a set screw, to retain a spinal rod within the cavity 92. The thread form of the implant receiver 84 may also engage the threaded outer surface 82 of the tip 70 to couple the sleeve 44 to the implant receiver 84, as described herein. In some embodiments, the inner surface of the implant receiver 84 may be disposed with the coupling member and / or tip 70 in an alternative securement configuration, such as, for example, a friction fit, a pressure fit, a locking projection / recess, a locking keyway, and / or an adhesive. In some embodiments, all or only a portion of the inner surface of the implant receiver 84 may have alternative surface configurations to enhance engagement with the spinal rod, set screw, and / or tip 70, such as, for example, roughened, arcuate, wavy, mesh, porous, semi-porous, dimpled, and / or textured. In some embodiments, the implant receiver 92 may include alternative configurations, such as, for example, closed, open, and / or lateral access. In some embodiments, the bone fastener 80 includes a crown 98 configured to facilitate positioning of the spinal rod.

[0046] The implant receiver 84 defines a cavity 100 configured to receive the head of the threaded shaft 86, as described herein. The threaded shaft 86 includes a socket, such as, for example, a tool-engaging portion 102, configured to engage with a drive portion of the end 74. The threaded shaft 86 includes an outer surface having an external thread form. In some embodiments, the external thread form may include a single thread or multiple separate threads. The threaded shaft 86 includes an inner surface 104 that defines a bore 106 that extends the entire length of the threaded shaft 86. When the drive portion of the end 74 engages with the tool-engaging portion 102, the bore 78 is in communication with and coaxial with the bore 106. In some embodiments, the threaded shaft 86 includes one or more openings, each extending through the surface 104 and the opposing outer surface 108 of the threaded shaft 86, such that, for example, a material, such as bone cement, disposed within the hole 106 can exit the hole 106 through one of the openings extending through the surfaces 104, 108 and / or through an opening 110 at the distal end of the threaded shaft 86 that is coaxial with the axis L1 when the fastener 80 is coupled to the sleeve 44.

[0047] In some embodiments, the implant receiver 84 is manually engageable with the threaded shaft 86 in a non-instrument assembly, as described herein. In some embodiments, manual engagement and / or non-instrument assembly of the implant receiver 84 and threaded shaft 86 includes coupling without the use of a separate and / or independent instrument engaged with the components to effect the assembly. In some embodiments, manual engagement and / or non-instrument assembly includes a practitioner, surgeon, and / or medical staff grasping the implant receiver 84 and threaded shaft 86 and forcing the components to assemble. In some embodiments, manual engagement and / or non-instrument assembly includes a practitioner, surgeon, and / or medical staff grasping the implant receiver 84 and threaded shaft 86 and forcing a snap-fit ​​of the components together, as described herein. In some embodiments, manual engagement and / or non-instrument assembly includes a practitioner, surgeon, and / or medical staff grasping the implant receiver 84 and threaded shaft 86 and forcing a pop-fit ​​of the components together and / or a pop fitting of the implant receiver 84 onto the threaded shaft 86, as described herein. In some embodiments, a force in the range of 2-50 N is required to manually engage the implant receiver 84 and threaded shaft 86 and force the components together. In some embodiments, a force in the range of 5-10 N is required to manually engage the implant receiver 84 and threaded shaft 86 and force the components together.

[0048] In some embodiments, the implant receiver 84 is connectable with the threaded shaft 86 such that the threaded shaft 86 is pivotable and / or rotatable in multiple planes relative to the implant receiver 84. In some embodiments, the implant receiver 84 is connectable with the threaded shaft 86 to include a variety of configurations, such as, for example, a posted screw, a pedicle screw, a bolt, a transverse plate bone screw, an interbody screw, a uniaxial screw (UAS), a fixed angle screw (FAS), a polyaxial screw (MAS), a side load screw, a sagittal adjustment screw (SAS), a transverse sagittal adjustment screw (TSAS), an awl tip (ATS), a dual rod polyaxial screw (DRMAS), a midline lumbar fusion screw, and / or a sacral screw.

[0049] To connect the driver 32 with the fastener 80, the tip 70 is inserted into the implant cavity 92 and the sleeve 44 is rotated relative to the sleeve 34 such that the threads on the outer surface 82 of the tip 70 mate with the thread profile of the implant receiver 84 to couple the sleeve 44 with the receiver 84. The sleeve 44 is further rotated relative to the sleeve 34 such that the drive portion of the end 74 is positioned within the tool engaging portion 102 to couple the sleeve 44 with the screw 86. In some embodiments, as described herein, at the same time that the drive portion of the end 74 is positioned within the tool engaging portion 86, the threads on the outer surface 82 of the tip 70 mate with the thread profile of the implant receiver 84 to position the receiver 84 with respect to the screw 86 such that the receiver 84 and screw 86 extend parallel to the axis L1 and maintain such positioning as the fastener 80 is driven into bone or other tissue using the driver 32. That is, engaging the threads on the outer surface 82 of the tip 70 with the thread profile of the implant receiver 84 while the drive portion of the end 74 is positioned within the tool engaging portion 86 prevents the receiver 84 from pivoting relative to the threads 86.

[0050] The delivery system 30 includes a second instrument, such as, for example, a bone filler device 112. The device 112 includes a shaft 114 and a handle 116 coupled to the shaft 114. In some embodiments, the handle 116 is permanently fixed to the shaft 114 such that the handle 116 cannot be removed from the shaft 114 without fracturing the handle 116 and / or the shaft 114. In some embodiments, the handle 116 is integrally and / or monolithically formed with the shaft 114. In some embodiments, the handle 116 is removably connected to the shaft 114 such that the handle 116 can be removed from the shaft 114 without fracturing the handle 116 and / or the shaft 114.

[0051] The shaft 114 is configured to be disposed within the channel 68 and extends along a longitudinal axis L2 between an end 118 and an opposing end 120. The handle 116 is connected to the end 118. In some embodiments, the shaft 114 tapers from the end 118 to the end 120 such that the end 118 has a minimum diameter that is greater than the minimum diameter of the end 120. In some embodiments, the shaft 114 has a uniform diameter along the entire length of the shaft 114. The shaft 114 includes an inner surface 122 that defines a lumen 124, as best shown in FIG. 7. The lumen 124 is coaxial with the axis L2 and extends the entire length of the shaft 114 such that the lumen 124 extends through the opposing end faces of the ends 118, 120. In some embodiments, the lumen 124 has a circular diameter. In some embodiments, the lumen 124 has a diameter that tapers along the length of the shaft 114. In some embodiments, the lumen 124 may be disposed, for example, transverse, perpendicular, and / or in other angled orientations, e.g., acute or obtuse angles, coaxially, and / or offset or staggered relative to the axis L2. In some embodiments, the lumen 124 may have various cross-sectional configurations, e.g., elliptical, oval, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable, tubular, and / or tapered.

[0052] The handle 116 includes a body 12 including a shaft 114 and a tubular portion 128 that is coaxial with the axis L2. 6. The barrel 128 has a threaded outer surface 130 and an opposing inner surface 132 defining an opening 134 in communication with and coaxial with the bore 124, as best seen in FIG. 7. The body 126 includes a conical portion 136 opposing the barrel 128. The conical portion 136 is configured to be disposed within the channel 68 to connect the handle 116 with the sleeve 44, as described herein. The conical portion 136 helps to facilitate communalization of the device 112 relative to the driver 32 to ensure proper assembly.

[0053] The handle 116 includes a second mating element including a first wing portion 138 extending from a first side 140 of the body 126 in a cantilevered configuration and a second wing portion 142 extending from an opposing second side 144 of the body 126 in a cantilevered configuration. The wing portion 138 includes an extension 146 extending from the first side 140, a gripping portion 148 extending from the extension 146, and a tab 150 extending from the extension 146. The wing portion 142 includes an extension 152 extending from the second side 144, a gripping portion 154 extending from the extension 152, and a tab 156 extending from the extension 152. The extensions 146, 152 each extend parallel to the axis L2. The gripping portions 148, 154 each extend transversely to the axis L2. Each of the tabs 150, 156 extends perpendicular to the axis L2. The tab 150 includes a surface 150a extending parallel to the axis L2, and the tab 156 includes a surface 156a extending parallel to the axis L2. The surface 150a faces the surface 156a. The tab 150 includes a surface 150b extending perpendicular to the axis L2, and the tab 156 includes a surface 156b extending perpendicular to the axis L2. The tabs 150, 156 are configured to engage the flange 50 to secure the device 112 to the driver 32 to prevent axial translation of the device 112 relative to the driver 32 in the direction indicated by arrow A in FIG. 12. The surface 150a is spaced a first distance from the surface 156a when no force is applied to the wing portions 138, 142. The wing portions 138, 142 are configured to deflect relative to the body 126. For example, a force may be applied to gripping portion 148 to move gripping portion 148 relative to body 126 in the direction indicated by arrow B in Figure 8, and a force may be applied to gripping portion 154 to move gripping portion 154 relative to body 126 in the direction indicated by arrow C in Figure 8, causing tabs 150, 156 to move away from one another and surface 150a to be spaced an increased second distance away from surface 156a. In some embodiments, wing portions 138, 142 are resiliently biased inwardly such that a force is removed from gripping portions 148, 154 to cause tabs 150, 156 to move toward one another and cause surface 150a to be spaced an increased first distance away from surface 156a.

[0054] To connect the device 112 with the sleeve 44, the shaft 114 is inserted into the channel 68 such that the axis L2 is coaxial with the axis L1. The device 112 is then translated axially relative to the sleeve 44 in the direction indicated by the arrow D in FIG. 9 until the conical portion 136 is disposed within the channel 68. As the device 112 is translated axially relative to the sleeve 44 in the direction indicated by the arrow D in FIG. 9, the surface 150a of the tab 150 slides along the surface 60 of the flange 50, as shown in FIG. 11, and the surface 156a of the tab 156 slides along the surface 60. As the surfaces 150a, 156a slide along the surface 60, the wings 138, 142 are deflected outwardly from the body 126 such that the distance between the surfaces 150a, 156a increases from a first distance to a second distance. When surfaces 150a, 156a are spaced a second distance apart such that surfaces 150a, 156a slide along surface 62 of flange 50, device 112 is further translated axially relative to sleeve 44 in the direction indicated by arrow D in FIG. 9 such that tabs 150, 156 are aligned with recesses 54. As shown in FIGS. 12 and 13, an inward bias of wings 138, 142 causes tabs 150, 156 to move relative to one another such that surface 150a is spaced a first distance from surface 156a and surfaces 150b, 156b engage surface 58 of flange 50. 12 , preventing axial translation of device 112 relative to sleeve 44 in the direction indicated by arrow A in FIG. 12 . In some embodiments, tabs 150, 156 produce a clicking sound as tabs 150, 156 move toward one another and surfaces 150b, 156b engage surfaces 58 of flange 50, indicating that device 112 is properly assembled with sleeve 44.

[0055] To remove device 112 from sleeve 44, a force is applied to gripping portion 148 to move gripping portion 148 in the direction indicated by arrow B in FIG. 8 relative to body 126, and a force is applied to gripping portion 154 to move gripping portion 154 in the direction indicated by arrow C in FIG. 8 relative to body 126 such that surface 150a is spaced a second distance away from surface 156a. Device 112 is translated axially relative to sleeve 44 in the direction indicated by arrow A in FIG. 12 such that surfaces 150a, 156a slide along surface 62. Device 112 may be translated axially relative to sleeve 44 in the direction indicated by arrow A in FIG. 12 until shaft 114 is removed from channel 68.

[0056] In assembly, operation, and use, the driver 32 is coupled with the fastener 80 as described herein. Access to the surgical site is gained and the particular surgical procedure is performed. The components of the delivery system 30 are used to augment the surgical procedure. For example, the fastener 80 may be inserted into bone or other tissue using the driver 32, e.g., via clockwise or counterclockwise rotation of the sleeve 44 relative to the sleeve 34. The device 112 is coupled with the driver 32 either before or after the fastener 80 is inserted into the bone or other tissue.

[0057] In one embodiment shown in FIGS. 14 and 15, a bone filler material, such as, for example, bone cement, is inserted into the lumen 124 through the opening 134. The bone filler material may be inserted into the lumen 124 before or after the device 112 is connected with the driver 32. The plunger 158 is aligned with the opening 134 as shown in FIG. 14. The plunger 158 is then translated relative to the handle 116 in the direction shown by arrow E in FIG. 15, which causes the plunger 158 to push the bone filler material through the lumen 124 and the holes 78, 106, which then exit the screw 86 through one or more openings in the screw 86. As the bone filler material hardens, it bonds the screw 86 with the bone or other tissue. Once the surgical procedure is completed, the plunger 158 may be detached from the device 112 and the driver 32 is removed from the surgical site. In some embodiments, the device 112 is disengaged from the driver 32 either before or after the driver 32 is removed from the surgical site. In some embodiments, a spinal structure, such as, for example, a spinal rod, is inserted into implant cavity 92 after driver 32 is removed from the surgical site, and a set screw is engaged with receiver 84 such that threads on the exterior surface of the set screw engage threads on the interior surfaces of arms 88, 90. The set screw is rotated relative to receiver 84 until the set screw engages the rod and secures it relative to receiver 84.

[0058] In one embodiment shown in FIG. 16, the delivery system 30 includes a cement delivery system 160 having a cartridge 162 connected to the handle 112 by a luer lock 164 and a cement delivery gun 166 connected to the cartridge 162. The threads of the luer lock 164 mate with the threads of the surface 130 to connect the cartridge 162 to the handle 112. The cartridge 162 is filled with a bone filler material, such as bone cement, either before or after the cartridge 162 is connected to the handle 112. An actuator, such as a trigger handle of the cement delivery gun 166, for example, moves the bone filler material through the lumen 124 and the holes 78, 106, such that the bone filler material exits the screw 86 through one or more openings in the screw 86. The engagement of the surfaces 150b, 156b prevents the device 112 from being translated axially relative to the sleeve 44 in the direction indicated by arrow A in FIG. 12 by the back pressure generated by the cement delivery gun 166. Once the bone filler material has hardened, the cement delivery gun 166 is moved to the bore 124 and the holes 78, 106. , connecting the screw 86 with bone or other tissue. Once the surgical procedure is completed, the cement delivery system 160 may be detached from the device 112 and the driver 32 is removed from the surgical site. In some embodiments, the device 112 is disengaged and / or disconnected from the driver 32 either before or after the driver 32 is removed from the surgical site. In some embodiments, a spinal structure, such as, for example, a spinal rod, is inserted into the implant cavity 92 after the driver 32 is removed from the surgical site and the set screw is engaged with the receiver 84 such that threads on the outer surface of the set screw engage threads on the inner surface of the arms 88, 90. The set screw is rotated relative to the receiver 84 until the set screw engages the rod and secures the rod relative to the receiver 84.

[0059] The delivery system 30 can include one or more bone fasteners, such as those described herein and / or fixation elements, which can be used at a single vertebral level or multiple vertebral levels. In some embodiments, the bone fasteners may be engaged with the vertebrae in various orientations, such as in-line, parallel, offset, staggered, and / or at alternate vertebral levels. In some embodiments, the bone fasteners and / or fixation elements can include one or more polyaxial screws, sagittal angulation screws, pedicle screws, uniaxial screws, uniplanar screws, fixation screws, tissue penetrating screws, conventional screws, expansion screws, wedges, anchors, buttons, clips, snaps, friction fits, compression fittings, expansion rivets, staples, nails, adhesives, posts, fixation plates and / or posts. In some embodiments, the system 30 may include various instruments including configurations of the present disclosure, such as, for example, inserters, extenders, reducers, spreaders, distractors, blades, retractors, clamps, forceps, elevators, and drills, which may be alternately sized and dimensioned and arranged as a kit according to the requirements of a particular application.

[0060] In some embodiments, the delivery system 30 includes a medicinal agent that may be disposed, loaded, coated, or layered in, on, or around components and / or surfaces of the delivery system 30. In some embodiments, the medicinal agent may include bone growth promoting materials, such as bone grafts, to enhance fixation of the vertebrae and the fixation elements. The components of the delivery system 30 may be made of radiolucent materials, such as polymers. Radiographic markers may be included for identification under x-ray, fluoroscopy, CT, or other imaging techniques. In some embodiments, the medicinal agent may include one or more therapeutic agents and / or drugs for release, including sustained release, to treat, for example, pain, inflammation, and degeneration.

[0061] In one embodiment, as shown in FIGS. 17-21, the delivery system 30 includes a driver 168 similar to the driver 32. The driver 168 includes an outer sleeve 170 having a lower portion 172 and an upper portion 174 connected to the lower portion 172. The lower portion 172 extends along a longitudinal axis L3 between an end 176 and an opposing end 178. The end 176 includes a circumferential cutout 180 configured to position an end 182 of the upper portion 174 to connect the upper portion 174 to the lower portion 172. In some embodiments, the upper portion 174 is connected to the lower portion 172 such that the upper portion 174 is provisionally secured relative to the lower portion 172 such that rotation of the upper portion 174 about axis L3 also rotates the lower portion 172 about axis L3. In some embodiments, the upper portion 174 may be variously connected to the lower portion 172, such as, for example, monolithic, integrally connected, frictionally engaged, threadedly engaged, reciprocating grooves, threads, adhesives, tabs, barbs, and / or raised elements. End 178 includes a tip 184 that defines a drive portion configured to engage an implant, such as, for example, a bone fastener 80, as described herein. In some embodiments, the drive portion can include a square, triangular, polygonal, star, or hexalobe cross-sectional configuration configured to engage a correspondingly shaped tool engagement portion 102 of the fastener 80.

[0062] Top 174 includes an end 182 and an opposing end 186. End 186 includes a first mating element, such as a flange 188 similar to flange 50. Flange 188 is spaced from flange 190 by an undercut, such as a recess 192. 8 includes opposing surfaces 194, 196 each extending perpendicular to axis L3, and surfaces 198, 200 respectively disposed between surfaces 194, 196, as best seen in Figures 20 and 21. Surface 194 defines an end face of end 186. Surface 198 extends transversely to axis L3, and surface 200 extends parallel to axis L3.

[0063] The lower portion 172 includes an inner surface 202 that defines a passageway 204, and the upper portion 174 includes an inner surface 206 that defines a channel 208 that is in communication with and coaxial with the passageway 204. The passageway 204 and the channel 208 are configured to position the inner sleeve 210 such that the sleeve 210 is rotatable relative to the sleeve 170 about an axis L3. The sleeve 210 includes an end 212 and an opposing end 214 having a threaded outer surface 228. A distal portion of the end 212 is positioned within the passageway 204, and a proximal portion 216 of the end 212 is positioned within the channel 208. The proximal portion 216 includes an inner surface 218 that defines a socket 220. In some embodiments, the socket 220 may include a square, triangular, polygonal, star, or hexalobe cross-sectional configuration configured to engage a correspondingly shaped portion of the thumbwheel 222 as described herein.

[0064] Top 174 includes a window 224 configured to allow visualization of a portion of device 112 and a window 226 configured to allow grasping of thumbwheel 222. Thumbwheel 222 includes a bit (not shown) disposed in socket 220. The bit has a shape corresponding to the shape of socket 220 such that rotation of thumbwheel 222 relative to sleeve 170 about axis L3 also rotates sleeve 210 relative to sleeve 170 about axis L3.

[0065] To connect the driver 168 to the fastener 80, the thumbwheel 222 is rotated relative to the sleeve 170 in a first rotational direction, such as, for example, clockwise or counterclockwise, about axis L3. Rotation of the thumbwheel 222 relative to the sleeve 170 in the first rotational direction about axis L3 causes rotation of the sleeve 210 in the first rotational direction about axis L3 relative to the sleeve 170. As the sleeve 210 rotates in the first rotational direction about axis L3 relative to the sleeve 170, the threads on the surface 228 of the sleeve 210 mate with the threads on the inner surfaces of the arms 88, 90 of the fastener 80. Rotation of the sleeve 210 in the first rotational direction about axis L3 relative to the sleeve 170 axially translates the sleeve 210 relative to the sleeve 170 in the direction indicated by arrow F in FIG. 19 relative to sleeve 170, tip 184 is inserted into tool engaging portion 102 of screw 86. The simultaneous engagement of tip 184 and tool engaging portion 102 with the threads on surface 228 of sleeve 210 and the threads on the inner surfaces of arms 88, 90 of fastener 80 prevents screw 86 from pivoting relative to receiver 84.

[0066] To remove the driver 168 from the fastener 80, the thumbwheel 222 is rotated relative to the sleeve 170 about axis L3 in an opposite second rotational direction, such as, for example, clockwise or counterclockwise. Rotation of the thumbwheel 222 relative to the sleeve 170 about axis L3 in the second rotational direction causes rotation of the sleeve 210 in the second rotational direction about axis L3 relative to the sleeve 170. As the sleeve 210 rotates about axis L3 in the second rotational direction relative to the sleeve 170, the sleeve 210 translates axially relative to the sleeve 170 in the direction indicated by arrow G in FIG. 19. As the sleeve 210 translates axially relative to the sleeve 170 in the direction indicated by arrow G in FIG. 19, the tip 184 moves out of the tool engagement portion 102 of the screw 86 and the threads on the surface 228 of the sleeve 210 disengage the threads on the inner surfaces of the arms 88, 90 of the fastener 80, at which point the driver 168 may be completely removed from the fastener 80.

[0067] In assembly, operation, and use, the driver 168 is connected with the fastener 80, as described herein. Access to the surgical site is gained and the particular surgical procedure is performed. The components of the delivery system 30 are used to augment the surgical procedure. For example, the fastener 80 may be inserted into bone or other tissue using the driver 168, such as via clockwise or counterclockwise rotation of the sleeve 170.

[0068] The device 112 is connected to the driver 168 either before or after the fastener 80 is inserted into the bone or other tissue. To connect the device 112 to the driver 168, the shaft 114 is inserted into the channel 208 such that the axis L3 is coaxial with the axis L1. The device 112 is then translated axially relative to the sleeve 170 in the direction indicated by arrow F in FIG. 19 until the shaft 114 extends through the thumbwheel 222 and the conical portion 136 is positioned within the channel 208. As the device 112 is translated axially relative to the sleeve 170 in the direction indicated by arrow F in FIG. 19, the surface 150a of the tab 150 slides along the surface 198 of the flange 188 and the surface 156a of the tab 156 slides along the surface 198. As surfaces 150a, 156a slide along surface 198, wings 138, 142 deflect outwardly from body 126 such that the distance between surfaces 150a, 156a increases from a first distance to a second distance. When surfaces 150a, 156a are spaced apart the second distance such that surfaces 150a, 156a slide along surface 200 of flange 188, device 112 is further translated axially relative to sleeve 170 in the direction indicated by arrow F in FIG. 19. Device 112 is further translated axially relative to sleeve 170 in the direction indicated by arrow F in FIG. 19 such that tabs 150, 156 are aligned with recesses 198. As shown in Figure 17, the inward bias of the wings 138, 142 causes the tabs 150, 156 to move toward each other such that surface 150a is spaced a first distance from surface 156a and surfaces 150b, 156b engage surface 196 of flange 188, preventing axial translation of device 112 relative to sleeve 170 in the direction indicated by arrow G in Figure 19. In some embodiments, the tabs 150, 156 produce a clicking sound as the tabs 150, 156 move toward each other and surfaces 150b, 156b engage surface 196 of flange 188, indicating that device 112 is properly assembled with sleeve 170.

[0069] In one embodiment, bone filler material, such as, for example, bone cement, is inserted into the lumen 124 through the opening 134. The bone filler material may be inserted into the lumen 124 after the device 112 is connected with the driver 168. The plunger 158 is aligned with the opening 134. The plunger 158 is then translated relative to the handle 116 in the direction shown by arrow F in FIG. 19, causing the plunger 158 to push the bone filler material through the lumen 124, the opening 230 extending through the tip 184, and the bore 106, causing the bone filler material to exit the screw 86 through one or more openings in the screw 86. As the bone filler material hardens, it bonds the screw 86 with the bone or other tissue. Once the surgical procedure is completed, the plunger 158 may be detached from the device 112 and the driver 168 is removed from the surgical site. In some embodiments, the device 112 is disengaged from the driver 168 either before or after the driver 168 is removed from the surgical site. To remove device 112 from sleeve 170, a force is applied to gripping portion 148 to move gripping portion 148 in the direction indicated by arrow B in FIG. 8 relative to body 126, and a force is applied to gripping portion 154 to move gripping portion 154 in the direction indicated by arrow C in FIG. 8 relative to body 126, such that surface 150a is spaced a second distance away from surface 156a. Device 112 is translated axially relative to sleeve 170 in the direction indicated by arrow F in FIG. 19 such that surfaces 150a, 156a slide along surface 200. Device 112 may be translated axially relative to sleeve 170 in the direction indicated by arrow F in FIG. 19 until shaft 114 is removed from channel 208. In some embodiments, a spinal structure, such as, for example, a spinal rod, may be inserted into the sleeve 170 after driver 168 is removed from the surgical site. The rod is inserted into implant cavity 92 and engaged with receiver 84 such that the threads on the exterior surface of the set screw engage the threads on the interior surfaces of arms 88, 90. The set screw is rotated relative to receiver 84 until the set screw engages the rod such that the rod is fixed relative to receiver 84.

[0070] In one embodiment, the threads of the luer lock 164 mate with the threads of the surface 130 to connect the cartridge 162 to the handle 112. The cartridge 162 is filled with a bone filler material, such as bone cement, for example, either before or after the cartridge 162 is connected to the handle 112. The trigger handle of the cement delivery gun 166 moves the bone filler material through the bore 124, the opening 230 and the bore 106, causing the bone filler material to exit the screw 86 through one or more openings in the screw 86. As the bone filler material hardens, it bonds the screw 86 to the bone or other tissue. Once the surgical procedure is completed, the cement delivery system 160 may be detached from the device 112 and the driver 168 is removed from the surgical site. In some embodiments, the device 112 is disengaged from the driver 168 either before or after the driver 168 is removed from the surgical site. In some embodiments, a spinal structure, such as, for example, a spinal rod, is inserted into implant cavity 92 after driver 168 is removed from the surgical site, and the set screw is engaged with receiver 84 such that threads on the exterior surface of the set screw engage threads on the interior surfaces of arms 88, 90. The set screw is rotated relative to receiver 84 until the set screw engages the rod such that the rod is fixed relative to receiver 84.

[0071] It will be understood that various modifications may be made to the embodiments disclosed herein. Accordingly, the above description should be interpreted merely as illustrative of various embodiments, and not as limiting. Other modifications that do not depart from the scope and spirit of the claims appended hereto will occur to those skilled in the art.

Claims

1. A delivery system comprising:

1. An implant comprising a threaded screw and a head coupled to the screw, an implant, the screw including a bore extending through opposing ends of the screw and the head having a threaded inner surface; a first instrument comprising an outer sleeve defining a passageway, the inner sleeve having a first end rotatably disposed within the passageway and a second end including a first mating element, the inner sleeve defining a channel, the first end defining an opening in communication with the channel, the first instrument having a tip removably connected to the inner sleeve, the tip having a threaded outer surface that engages the threaded inner surface to couple the tip to the head, the tip having a flange positioned within the channel, the flange having a diameter greater than a diameter of the opening, the tip having a drive portion positioned within the bore; a second instrument comprising a hollow shaft disposed within the channel and defining a longitudinal axis, and a handle coupled to the shaft, the handle comprising a body and a second mating element extending from the body; and Equipped with the second mating element engages the first mating element to secure the second instrument to the first instrument, thereby preventing the second instrument from translating proximally relative to the first instrument; When attachment of the second instrument to the first instrument occurs, the tip is adapted to rotate relative to the head about the longitudinal axis. Delivery system.

2. The delivery system of claim 1 , wherein the hole is in communication with and coaxial with the channel.

3. The delivery system of claim 1 , wherein the first mating element is a flange extending outwardly from an outer surface of the inner sleeve.

4. 4. The delivery system of claim 3, wherein the second mating element comprises a first wing portion extending from a first side of the body of the handle in a cantilever configuration and a second wing portion extending from an opposing second side of the body of the handle in a cantilever configuration.

5. the first wing portion comprises an extension extending from the first side and a tab extending from the extension; the second wing portion includes an extension extending from the second side and a tab extending from the extension of the second wing portion; each of said extensions extends parallel to said longitudinal axis and each of said tabs extends perpendicular to said longitudinal axis, whereby end faces of said tabs each extend parallel to said longitudinal axis; The delivery system of claim 4 , wherein the tab engages the flange of the inner sleeve to secure the second instrument to the first instrument.

6. The delivery system of claim 5 , wherein the end faces of the tabs face each other.

7. 2. The delivery system of claim 1, wherein the handle body includes a barrel coaxial with the shaft, the barrel including a threaded outer surface and an inner surface defining an opening in communication with and coaxial with a lumen of the shaft.

8. 8. The delivery system of claim 7, further comprising an injector coupled to the barrel, the injector having bone cement therein, the injector configured to deliver the bone cement through the opening and the lumen and into the hole.

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