Patent Description:
Spinal pathologies and disorders such as scoliosis, kyphosis, and other curvature abnormalities, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, tumor and fracture may result from factors including trauma, disease and degenerative conditions caused by injury and aging. Spinal disorders typically result in symptoms including deformity, pain, nerve damage, and partial or complete loss of mobility.

Non-surgical treatments, such as medication, rehabilitation and exercise can be effective, however, may fail to relieve the symptoms associated with these disorders. Surgical treatment of these spinal disorders includes correction, fusion, fixation, discectomy, laminectomy and implantable prosthetics.

<CIT> discloses a system for delivering bone cement to a bone anchor, the system comprises an anchor connection instrument for releasably connecting to a proximal end of the bone anchor. As part of these surgical treatments, spinal constructs such as vertebral rods are often used to provide stability to a treated region. Rods redirect stresses away from a damaged or defective region while healing takes place to restore proper alignment and generally support vertebral members. During surgical treatment, one or more rods and bone fasteners can be delivered to a surgical site. The rods may be attached via the bone fasteners to the exterior of two or more vertebral members. A surgeon may stabilize the vertebra by using a driver to insert the bone fasteners into the damaged vertebral body and attach the fasteners to one or more rods to help support and stabilize the damaged vertebra. It is sometimes difficult for the surgeon to achieve the required support and stabilization for the damaged vertebral body because the threads of the bone fasteners do not properly engage the vertebral bone. Therefore, the surgeon may insert a bone filler device into the driver to deliver an adhesive material or cement material in and/or around at least one of the bone fasteners using an injection gun that is coupled to the bone filler device to further bond at least one of the fasteners with bone. However, the injection gun often generates back pressure that causes the bone filler device to become disconnected from the driver. As a result, a separate instrument is required to prevent the bone filler device from being disconnected from the driver when the injection gun generates back pressure. Another common method of cement injection uses one hand to hold the bone filler device in place, which acts as resistance to back pressure. A plunger is used by the other hand to distribute the cement. This disclosure describes an improvement over these prior technologies.

In one embodiment, a delivery system is provided. The delivery system comprises a first instrument and a second instrument. The first instrument comprises an outer sleeve defining a passageway. The first instrument comprises an inner sleeve having a first end disposed in the passageway and a second end that includes a first mating element. The inner sleeve defines a channel. The second instrument comprises a hollow shaft that is disposed in the channel and a handle that is coupled to the shaft. The handle comprises a body and a second mating element that extends 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 one embodiment, a delivery system is provided. The delivery system comprises an implant, a first instrument and a second instrument. The implant comprises a threaded screw and a head that is coupled to the screw. The screw comprises a bore that extends through opposite ends of the screw. The head has a threaded inner surface. The first instrument comprises an outer sleeve defining a passageway. The first instrument comprises an inner sleeve having a first end that is rotatably disposed in the passageway and a second end that includes a first mating element. The first end comprises a threaded outer surface that engages the threaded inner surface to couple the inner sleeve to the head. The first end comprises a tip that is positioned in the bore to couple the inner sleeve to the screw. The inner sleeve defines a channel. The second instrument comprises a hollow shaft that is disposed in the channel and a handle that is coupled to the shaft. The handle comprises a body and a second mating element that extends from the body. The second mating element engages the first mating element to secure the second instrument to the first instrument such that the second instrument is prevented from translating proximally relative to the first instrument.

In one embodiment, a delivery system is provided. The delivery system comprises a bone fastener, a driver, a bone filler device and an injector. The bone fastener comprises a threaded screw and a head that is coupled to the screw. The screw is rotatable relative to the head in multiple planes. The screw comprises an inner surface defining a bore that extends through opposite ends of the screw. The screw comprises an opening that extends through the inner surface and an opposite outer surface of the screw. The head has a threaded inner surface. The driver comprises an outer sleeve defining a passageway. The driver comprises an inner sleeve having a first end that is rotatably disposed in the passageway and a second end that includes a flange. The first end comprises a threaded outer surface that engages the threaded inner surface to couple the inner sleeve to the head. The first end comprises a tip that is positioned in the bore to couple the inner sleeve to the screw. The inner sleeve defines a channel. The bone filler device comprises a hollow shaft that is disposed in the channel and a handle that is coupled to the shaft. The handle comprises a body including a cylindrical portion that is coaxial with the shaft. The cylindrical portion has a threaded outer surface and an inner surface defining an opening that is in communication and coaxial with a lumen of the shaft. The handle comprises a first wing that extends from a first side the body in a cantilevered configuration and a second wing that extends from an opposite second side of the body in a cantilevered configuration. The first wing comprises an extension that extends from the first side and a tab that extends from the extension. The second wing comprises an extension that extends from the second side and a tab that extends from the extension of the second wing. The extensions each extend parallel to a longitudinal axis defined by the shaft and the tabs each extend perpendicular to the longitudinal axis. The tabs engage the flange to secure the bone filler device to the driver such that the bone filler device is prevented from translating proximally relative to the driver. The injector is coupled to the handle and comprises bone cement therein. The injector is configured to deliver the bone cement through the channel and into the bore.

The embodiments of the surgical system and related methods (not claimed) of use disclosed are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a delivery system and a method for treating a spine. In some embodiments, the systems and methods (not claimed) of the present disclosure comprise medical devices including surgical instruments and implants that are employed with a surgical treatment, as described herein, for example, with a cervical, thoracic, lumbar and/or sacral region of a spine.

A cement delivery gun creates back pressure when used in connection with a predicate bone filler device. A current fenestrated screw system relies on an extra instrument to counteract the back pressure generated by the cement delivery system gun. On the other hand, in various embodiments, the delivery system of the present disclosure simplifies the procedure by removing unnecessary steps while still providing the function needed. In some embodiments, the present delivery system eliminates the need for a separate instrument to secure a bone filler device to its guide/driver and includes a handle having a specific shape developed to retain proper connection between the handle and the guide/driver during cement application. In some embodiments, the handle includes wings having a shape that allows both easy attachment to an undercut in the guide/driver. The handle also provides an ergonomic feature that allows simple release the bone filler device from the guide/driver. In some embodiments, a distal end of the handle having a conical shape that helps facilitate axilization of the bone filler device ensuring proper assembly of the handle with the guide/driver by aligning the handle with the guide/driver. In some embodiments, the handle and/or guide/drive will create clicking during assembly of the handle with the guide/driver to indicate that the handle has been properly assembled with the guide/driver.

In some embodiments, the delivery system of the present disclosure may be employed to treat spinal disorders such as, for example, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis, kyphosis, and other curvature abnormalities, tumor and fractures. In some embodiments, the delivery system of the present disclosure may be employed with other osteal and bone related applications, including those associated with diagnostics and therapeutics. In some embodiments, the disclosed delivery system may be alternatively employed in a surgical treatment with a patient in a prone or supine position, and/or employ various surgical approaches to the spine, including anterior, posterior, posterior mid-line, direct lateral, postero-lateral, and/or antero-lateral approaches, and in other body regions. The delivery system of the present disclosure may also be alternatively employed with procedures for treating the lumbar, cervical, thoracic, sacral and pelvic regions of a spinal column. The delivery system of the present disclosure may also be used on animals, bone models and other non-living substrates, such as, for example, in training, testing and demonstration.

The following discussion includes a description of a delivery system and related components and methods (not claimed) of employing the delivery system in accordance with the principles of the present disclosure. Alternate embodiments are also disclosed. Reference is made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. Turning to <FIG>, there are illustrated components of a delivery system, such as, a delivery system <NUM>.

The components of delivery system <NUM> can be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics and bone material and/or their composites. For example, the components of delivery system <NUM>, individually or collectively, can be fabricated from materials such as stainless steel alloys, aluminum, commercially pure titanium, titanium alloys, Grade <NUM> titanium, super-elastic titanium alloys, cobalt-chrome alloys, superelastic metallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL®), ceramics and composites thereof such as calcium phosphate (e.g., SKELITE™), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO<NUM> polymeric rubbers, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone material including autograft, allograft, xenograft or transgenic cortical and/or corticocancellous bone, and tissue growth or differentiation factors, partially resorbable materials, such as, for example, composites of metals and calcium-based ceramics, composites of PEEK and calcium based ceramics, composites of PEEK with resorbable polymers, totally resorbable materials, such as, for example, calcium based ceramics such as calcium phosphate, tri-calcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymers such as polyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe and their combinations.

Various components of delivery system <NUM> may have material composites, including the above materials, to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical performance, durability and radiolucency or imaging preference. The components of delivery system <NUM>, individually or collectively, may also be fabricated from a heterogeneous material such as a combination of two or more of the above-described materials. The components of delivery system <NUM> may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein.

Delivery system <NUM> is employed, for example, with a fully open surgical procedure, a minimally invasive procedure including percutaneous techniques, and mini-open surgical techniques to deliver and introduce instrumentation and/or a spinal implant, such as, for example, a bone fastener, at a surgical site of a patient, which includes, for example, a spine. In some embodiments, the spinal implant can include one or more components of one or more spinal constructs, such as, for example, interbody devices, interbody cages, bone fasteners, spinal rods, tethers, connectors, plates and/or bone graft, and can be employed with various surgical procedures including surgical treatment of a cervical, thoracic, lumbar and/or sacral region of a spine.

Delivery system <NUM> includes a first instrument, such as, for example, a driver <NUM>. Driver <NUM> includes a sleeve, such as, an outer sleeve <NUM> that extends along a longitudinal axis L1 between an end <NUM> and an opposite end <NUM>. Sleeve <NUM> has an inner surface <NUM> defining a passageway <NUM>, as best shown in <FIG>. Passageway <NUM> is coaxial with axis L1 and extends the entire length of sleeve <NUM> such that passageway <NUM> extends through opposite end surfaces of ends <NUM>, <NUM>. In some embodiments, passageway <NUM> has a circular diameter. In some embodiments, passageway <NUM> has a uniform diameter along the entire length of passageway <NUM>. In some embodiments, passageway <NUM> may be disposed at alternate orientations, relative to axis L1, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. In some embodiments, passageway <NUM> may have various cross section configurations, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable, tubular and/or tapered.

Driver <NUM> includes a sleeve, such as, for example, an inner sleeve <NUM> rotatably disposed in passageway <NUM> such that sleeve <NUM> is coaxial with axis L1. Sleeve <NUM> extends between an end <NUM> and an opposite end <NUM> that is disposed in passageway <NUM>. End <NUM> includes a first mating element, such as, for example, a flange <NUM> that is spaced apart from a flange <NUM> by an undercut, such as, for example, a recess <NUM>. Flange <NUM> includes opposite surfaces <NUM>, <NUM> that each extend perpendicular to axis L1 and surfaces <NUM>, <NUM> that are each positioned between surfaces <NUM>, <NUM>, as best shown in <FIG> and <FIG>. Surface <NUM> defines the end surface of end <NUM>. Surface <NUM> extends transverse to axis L1 and surface <NUM> extends parallel to axis L1.

Sleeve <NUM> includes a body <NUM> having an inner surface <NUM> that defines a channel <NUM>, as best shown in <FIG>. Channel <NUM> is coaxial with axis L1 and extends the entire length of sleeve <NUM> such that channel <NUM> extends through surface <NUM> and an opposite end surface of end <NUM>. In some embodiments, channel <NUM> has a circular diameter. In some embodiments, channel <NUM> has a uniform diameter along the entire length of channel <NUM>. In some embodiments, channel <NUM> may be disposed at alternate orientations, relative to axis L1, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. In some embodiments, channel <NUM> may have various cross section configurations, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable, tubular and/or tapered.

End <NUM> includes a tip <NUM> that is connected with body <NUM>, as best shown in <FIG>. In some embodiments, tip <NUM> is removably connected with body <NUM> such that tip <NUM> is disposable. In such embodiments, tip <NUM> may be provisionally fixed with body <NUM> such that rotation of body <NUM> also rotates tip <NUM>. In some embodiments, tip <NUM> is variously connected with body <NUM>, such as, for example, frictional engagement, threaded engagement, mutual grooves, screws, adhesive, nails, barbs and/or raised element. In some embodiments, tip <NUM> is integrally and/or monolithically formed with body <NUM> such that tip <NUM> cannot be removed from body <NUM> without breaking body <NUM> and/or tip <NUM>. Tip <NUM> extends between an end <NUM> and an opposite end <NUM>. Tip <NUM> includes an inner surface <NUM> defining a bore <NUM> that is coaxial with axis L1 and extends the entire length of tip <NUM> such that bore <NUM> extends through opposite end surfaces of ends <NUM>, <NUM>. In some embodiments, bore <NUM> has a circular diameter. In some embodiments, bore <NUM> has a uniform diameter along the entire length of bore <NUM>. In some embodiments, bore <NUM> may be disposed at alternate orientations, relative to axis L1, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. In some embodiments, bore <NUM> may have various cross section configurations, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable, tubular and/or tapered. End <NUM> is positioned in channel <NUM> such that bore <NUM> is in communication and coaxial with channel <NUM>. End <NUM> defines a drive portion configured for engagement with an implant, such as, for example, a bone fastener <NUM>, as discussed herein. In some embodiments, the drive portion may include a square, triangular, polygonal, star or hexalobe cross sectional configuration configured engage a correspondingly shaped portion of fastener <NUM>. In some embodiments, tip <NUM> includes a threaded outer surface that is configured to engage threads of fastener <NUM> to couple sleeve <NUM> to fastener <NUM>, as discussed herein.

Fastener <NUM> includes a head, such as, for example, an implant receiver <NUM> and a screw shaft <NUM> that is coupled to receiver <NUM>. Implant receiver <NUM> extends parallel to axis L1 when fastener <NUM> is coupled to sleeve <NUM>. Implant receiver <NUM> includes a pair of spaced apart arms <NUM>, <NUM> that define an implant cavity <NUM> therebetween configured for disposal of a spinal construct, such as, for example, a spinal rod. Arms <NUM>, <NUM> each extend parallel to axis L1 when fastener <NUM> is coupled to sleeve <NUM>. In some embodiments, arm <NUM> and/or arm <NUM> may be disposed at alternate orientations, relative to axis L1, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, coaxial and/or may be offset or staggered. Arms <NUM>, <NUM> each include an arcuate outer surface extending between a pair of side surfaces. At least one of the outer surfaces and the side surfaces of arms <NUM>, <NUM> have at least one recess or cavity therein configured to receive an insertion tool, compression instrument and/or instruments for inserting and tensioning bone fastener <NUM>.

Arm <NUM> includes a break away tab <NUM> that is frangibly connected to arm <NUM> (<FIG>) such that manipulation of tab <NUM> relative to arm <NUM> can fracture and separate tab <NUM> from arm <NUM> at a predetermined force and/or torque limit, as described herein. In some embodiments, as force and/or torque is applied to tab <NUM> and resistance increases, for example, the predetermined torque and force limit is approached. Arm <NUM> includes a break away tab <NUM> that is frangibly connected to arm <NUM> such that manipulation of tab <NUM> relative to arm <NUM> can fracture and separate tab <NUM> from arm <NUM> at a predetermined force and/or torque limit, as described herein. In some embodiments, as force and/or torque is applied to tab <NUM> and resistance increases, for example, the predetermined torque and force limit is approached.

In some embodiments, tabs <NUM>, <NUM> can fracture and separate at a predetermined force or torque limit, which may be in a range of approximately <NUM> Newton meters (N-m) to <NUM>. In some embodiments, tabs <NUM>, <NUM> and arms <NUM>, <NUM> may have the same or alternate cross section configurations, may be fabricated from a homogenous material or heterogeneously fabricated from different materials, and/or alternately formed of a material having a greater degree, characteristic or attribute of plastic deformability, frangible property and/or break away quality to facilitate fracture and separation of tabs <NUM>, <NUM> from arms <NUM>, <NUM>.

Cavity <NUM> is substantially U-shaped. In some embodiments, all or only a portion of cavity <NUM> may have alternate cross section configurations, such as, for example, closed, V-shaped, W-shaped, oval, oblong triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, and/or tapered. Implant receiver <NUM> includes thread forms configured for engagement with a coupling member, such as, for example, a setscrew to retain a spinal rod within cavity <NUM>. The thread forms of implant receiver <NUM> may also engage threaded outer surface <NUM> of tip <NUM> to couple sleeve <NUM> to implant receiver <NUM>, as discussed herein. In some embodiments, the inner surface of implant receiver <NUM> may be disposed with the coupling member and/or tip <NUM> in alternate fixation configurations, such as, for example, friction fit, pressure fit, locking protrusion/recess, locking keyway and/or adhesive. In some embodiments, all or only a portion of the inner surface of implant receiver <NUM> may have alternate surface configurations to enhance engagement with a spinal rod, a setscrew and/or tip <NUM>, such as, for example, rough, arcuate, undulating, mesh, porous, semi-porous, dimpled and/or textured. In some embodiments, implant receiver <NUM> may include alternate configurations, such as, for example, closed, open and/or side access. In some embodiments, bone fastener <NUM> includes a crown <NUM> configured to facilitate positioning of a spinal rod.

Implant receiver <NUM> defines a cavity <NUM> configured for disposal of a head of screw shaft <NUM>, as described herein. Screw shaft <NUM> includes a socket, such as, for example, a tool engaging portion <NUM> configured to engage the drive portion of end <NUM>. Screw shaft <NUM> includes an outer surface having an external thread form. In some embodiments, the external thread form may include a single thread turn or a plurality of discrete threads. Screw shaft <NUM> includes an inner surface <NUM> defining a bore <NUM> that extends the entire length of screw shaft <NUM>. When the drive portion of end <NUM> engages tool engaging portion <NUM>, bore <NUM> is in communication and coaxial with bore <NUM>. In some embodiments, screw shaft <NUM> includes one or a plurality of openings that each extend through surface <NUM> and an opposite outer surface <NUM> of screw shaft <NUM> such that a material, such as, for example, bone cement disposed in bore <NUM> can exit bore <NUM> through one of the openings that extend through surfaces <NUM>, <NUM> and/or through an opening <NUM> in a distal end of screw shaft <NUM> that is coaxial with axis L1 when fastener <NUM> is coupled to sleeve <NUM>.

In some embodiments, implant receiver <NUM> is manually engageable with screw shaft <NUM> in a non-instrumented assembly, as described herein. In some embodiments, manual engagement and/or non-instrumented assembly of implant receiver <NUM> and screw shaft <NUM> includes coupling without use of separate and/or independent instrumentation engaged with the components to effect assembly. In some embodiments, manual engagement and/or non-instrumented assembly includes a practitioner, surgeon and/or medical staff grasping implant receiver <NUM> and screw shaft <NUM> and forcibly assembling the components. In some embodiments, manual engagement and/or non-instrumented assembly includes a practitioner, surgeon and/or medical staff grasping implant receiver <NUM> and screw shaft <NUM> and forcibly snap fitting the components together, as described herein. In some embodiments, manual engagement and/or non-instrumented assembly includes a practitioner, surgeon and/or medical staff grasping implant receiver <NUM> and screw shaft <NUM> and forcibly pop fitting the components together and/or pop fitting implant receiver <NUM> onto screw shaft <NUM>, as described herein. In some embodiments, a force in a range of <NUM>-<NUM> N is required to manually engage implant receiver <NUM> and screw shaft <NUM> and forcibly assemble the components. In some embodiments, a force in a range of <NUM>-<NUM> N is required to manually engage implant receiver <NUM> and screw shaft <NUM> and forcibly assemble the components.

In some embodiments, implant receiver <NUM> is connectable with screw shaft <NUM> such that screw shaft <NUM> is pivotable and/or rotatable relative to implant receiver <NUM> in a plurality of planes. In some embodiments, implant receiver <NUM> is connectable with screw shaft <NUM> to include various configurations, such as, for example, a posted screw, a pedicle screw, a bolt, a bone screw for a lateral plate, an interbody screw, a uni-axial screw (UAS), a fixed angle screw (FAS), a multi-axial screw (MAS), a side loading screw, a sagittal adjusting screw (SAS), a transverse sagittal adjusting screw (TSAS), an awl tip (ATS), a dual rod multi-axial screw (DRMAS), midline lumbar fusion screw and/or a sacral bone screw.

To connect driver <NUM> with fastener <NUM>, tip <NUM> is inserted into implant cavity <NUM> and sleeve <NUM> is rotated relative to sleeve <NUM> such that the threads on outer surface <NUM> of tip <NUM> mate with the thread forms of implant receiver <NUM> to couple sleeve <NUM> with receiver <NUM>. Sleeve <NUM> is further rotated relative to sleeve <NUM> such that the drive portion of end <NUM> is positioned in tool engaging portion <NUM> to couple sleeve <NUM> with screw <NUM>. In some embodiments, the threads on outer surface <NUM> of tip <NUM> mate with the thread forms of implant receiver <NUM> at the same time that the drive portion of end <NUM> is positioned in tool engaging portion <NUM> to position receiver <NUM> relative to screw <NUM> such that receiver <NUM> and screw <NUM> extend parallel to axis L1 and maintain such positioning as fastener <NUM> is driven into bone or other tissue using driver <NUM>, as discussed herein. That is, mating the threads on outer surface <NUM> of tip <NUM> with the thread forms of implant receiver <NUM> at the same time that the drive portion of end <NUM> is positioned in tool engaging portion <NUM> prevents receiver <NUM> from pivoting relative to screw <NUM>.

Delivery system <NUM> includes a second instrument, such as, for example, a bone filler device <NUM>. Device <NUM> includes a shaft <NUM> and a handle <NUM> that is coupled to shaft <NUM>. In some embodiments, handle <NUM> is permanently fixed to shaft <NUM> such that handle <NUM> cannot be removed from shaft <NUM> without breaking handle <NUM> and/or shaft <NUM>. In some embodiments, handle <NUM> is integrally and/or monolithically formed with shaft <NUM>. In some embodiments, handle <NUM> is removably connected with shaft <NUM> such that handle <NUM> can be removed from shaft <NUM> without breaking handle <NUM> and/or shaft <NUM>.

Shaft <NUM> is configured for disposal in channel <NUM> and extends along a longitudinal axis L2 between an end <NUM> and an opposite end <NUM>. Handle <NUM> is connected with end <NUM>. In some embodiments, shaft <NUM> is tapered from end <NUM> to end <NUM> such that end <NUM> has a minimum diameter that is greater than a minimum diameter of end <NUM>. In some embodiments, shaft <NUM> has a uniform diameter along the entire length of shaft <NUM>. Shaft <NUM> comprises an inner surface <NUM> that defines a lumen <NUM>, as best shown in <FIG>. Lumen <NUM> is coaxial with axis L2 and extends the entire length of shaft <NUM> such that lumen <NUM> extends through opposite end surfaces of ends <NUM>, <NUM>. In some embodiments, lumen <NUM> has a circular diameter. In some embodiments, lumen <NUM> has a diameter that tapers along the length of shaft <NUM>. In some embodiments, lumen <NUM> may be disposed at alternate orientations, relative to axis L2, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. In some embodiments, lumen <NUM> may have various cross section configurations, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable, tubular and/or tapered.

Handle <NUM> comprises a body <NUM> including a cylindrical portion <NUM> that is coaxial with shaft <NUM> and axis L2. Cylindrical portion <NUM> has a threaded outer surface <NUM> and an opposite inner surface <NUM> defining an opening <NUM> that is in communication and coaxial with lumen <NUM>, as best shown in <FIG>. Body <NUM> comprises a conical portion <NUM> opposite cylindrical portion <NUM>. Conical portion <NUM> is configured for disposal in channel <NUM> to connect handle <NUM> with sleeve <NUM>, as discussed herein. Conical portion <NUM> helps facilitate axialization of device <NUM> relative to driver <NUM> to ensure proper assembly.

Handle <NUM> comprises a second mating element that includes a first wing <NUM> that extends from a first side <NUM> of body <NUM> in a cantilevered configuration and a second wing <NUM> that extends from an opposite second side <NUM> of body <NUM> in a cantilevered configuration. Wing <NUM> comprises an extension <NUM> that extends from first side <NUM>, a gripping portion <NUM> that extends from extension <NUM> and a tab <NUM> that extends from extension <NUM>. Wing <NUM> comprises an extension <NUM> that extends from second side <NUM>, a gripping portion <NUM> that extends from extension <NUM> and a tab <NUM> that extends from extension <NUM>. Extensions <NUM>,<NUM> each extend parallel to axis L2. Gripping portions <NUM>, <NUM> each extend transverse to axis L2. Tabs <NUM>, <NUM> each extend perpendicular to axis L2. Tab <NUM> includes a surface 150a that extends parallel to axis L2 and tab <NUM> includes a surface 156a that extends parallel to axis L2. Surface 150a faces surface 156a. Tab <NUM> includes a surface 150b that extends perpendicular to axis L2 and tab <NUM> includes a surface 156b that extends perpendicular to axis L2. Tabs <NUM>, <NUM> are configured to engage flange <NUM> to secure the device <NUM> to driver <NUM> such that device <NUM> is prevented from translating axially relative to driver <NUM> in the direction shown by arrow A in <FIG>. Surface 150a is spaced a first distance apart from surface 156a when no forces are applied to wings <NUM>, <NUM>. Wings <NUM>, <NUM> are configured to deflect relative to body <NUM>. For example, a force may be applied to gripping portion <NUM> to move gripping portion <NUM> relative to body <NUM> in the direction shown by arrow B in <FIG> and a force may be applied to gripping portion <NUM> to move gripping portion <NUM> relative to body <NUM> in the direction shown by arrow C in <FIG> such that tabs <NUM>, <NUM> move away from one another and surface 150a is spaced an increased second distance apart from surface 156a. In some embodiments, wings <NUM>, <NUM> are resiliently biased inwardly such that after the forces are removed from gripping portions <NUM>, <NUM> tabs <NUM>, <NUM> move toward one another such that surface 150a is spaced the first distance apart from surface 156a.

To connect device <NUM> with sleeve <NUM>, shaft <NUM> is inserted into channel <NUM> such that axis L2 is coaxial with axis L1. Device <NUM> is then translated axially relative to sleeve <NUM> in the direction shown by arrow D in <FIG> until conical portion <NUM> is positioned within channel <NUM>. As device <NUM> translates axially relative to sleeve <NUM> in the direction shown by arrow D in <FIG>, surface 150a of tab <NUM> slides along surface <NUM> of flange <NUM>, as shown in <FIG> and surface 156a of tab <NUM> slides along surface <NUM>. As surfaces 150a, 156a slide along surface <NUM>, wings <NUM>, <NUM> deflect outwardly from body <NUM> such that the distance between surfaces 150a, 156a increase from the first distance to a second distance. Device <NUM> is further translated axially relative to sleeve <NUM> in the direction shown by arrow D in <FIG> when surfaces 150a, 156a are spaced apart by the second distance such that surfaces 150a, 156a slide along surface <NUM> of flange <NUM>. Device <NUM> is further translated axially relative to sleeve <NUM> in the direction shown by arrow D in <FIG> such that tabs <NUM>, <NUM> are aligned with recess <NUM>. The inward bias of wings <NUM>, <NUM> causes tabs <NUM>, <NUM> to move toward one another such that surface 150a is spaced the first distance apart from surface 156a and surfaces 150b, 156b engage surface <NUM> of flange <NUM>, as shown in <FIG> and <FIG>, to prevent device <NUM> from translating axially relative to sleeve <NUM> in the direction shown by arrow A in <FIG>. In some embodiments, tabs <NUM>, <NUM> create a clicking sound when tabs <NUM>, <NUM> to move toward one another and surfaces 150b, 156b engage surface <NUM> of flange <NUM>, which indicates the device <NUM> is properly assembled with sleeve <NUM>.

To remove device <NUM> from sleeve <NUM>, a force is applied to gripping portion <NUM> to move gripping portion <NUM> relative to body <NUM> in the direction shown by arrow B in <FIG> and a force is applied to gripping portion <NUM> to move gripping portion <NUM> relative to body <NUM> in the direction shown by arrow C in <FIG> such that surface 150a is spaced the second distance apart from surface 156a. Device <NUM> is translated axially relative to sleeve <NUM> in the direction shown by arrow A in <FIG> such that surfaces 150a, 156a slide along surface <NUM>. Device <NUM> may be translated axially relative to sleeve <NUM> in the direction shown by arrow A in <FIG> until shaft <NUM> is removed from channel <NUM>.

In assembly, operation and use, driver <NUM> is connected with fastener <NUM> as discussed herein. Access to the surgical site is obtained and the particular surgical procedure is performed. The components of delivery system <NUM> are employed to augment the surgical treatment. For example, fastener <NUM> may be inserted into bone or other tissue with driver <NUM>, for example via clockwise or counterclockwise rotation of sleeve <NUM> relative to sleeve <NUM>. Device <NUM> is connected with driver <NUM> either before or after fastener <NUM> is inserted into bone or other tissue.

In one embodiment, shown in <FIG> and <FIG>, bone filler material, such as, for example, bone cement is inserted through opening <NUM> and into lumen <NUM>. The bone filler material may be inserted into lumen <NUM> before or after device <NUM> is connected with driver <NUM>. A plunger <NUM> is aligned with opening <NUM>, as shown in <FIG>. Plunger <NUM> is then translated relative to handle <NUM> in the direction shown by arrow E in <FIG> such that plunger <NUM> pushes the bone filler material through lumen <NUM> and bores <NUM>, <NUM> and the bone filler material exits screw <NUM> via one or more openings in screw <NUM>. As the bone filler material cures, it will bond screw <NUM> with bone or other tissue. Upon completion of a surgical procedure, plunger <NUM> may be removed from device <NUM>, and driver <NUM> is removed from the surgical site. In some embodiments, device <NUM> is disengaged from driver <NUM> either before or after driver <NUM> is removed from the surgical site. In some embodiments, a spinal construct, such as, for example, a spinal rod is inserted into implant cavity <NUM> after driver <NUM> is removed from the surgical site and a setscrew is engaged with receiver <NUM> such that threads on an outer surface of the setscrew engage the threads on the inner surfaces of arms <NUM>, <NUM>. The setscrew is rotated relative to receiver <NUM> until the setscrew engages the rod to fix the rod relative to receiver <NUM>.

In one embodiment, shown in <FIG>, delivery system <NUM> includes a cement delivery system <NUM> having a cartridge <NUM> that is connected to handle <NUM> by a luer lock <NUM> and a cement delivery gun <NUM> that is connected to cartridge <NUM>. Threads of luer lock <NUM> are mated with threads of surface <NUM> to connect cartridge <NUM> to handle <NUM>. Cartridge <NUM> is loaded with a bone filler material, such as, for example, bone cement either before or after cartridge <NUM> is connected to handle <NUM>. An actuator, such as, for example, a trigger handle of cement delivery gun <NUM> is activated to move the bone filler material through lumen <NUM> and bores <NUM>, <NUM> such that the bone filler material exits screw <NUM> via one or more openings in screw <NUM>. Engagement of surfaces 150b, 156b prevents device <NUM> from translating axially relative to sleeve <NUM> in the direction shown by arrow A in <FIG> due to back pressure generated by cement delivery gun <NUM>. As the bone filler material cures, it will bond screw <NUM> with bone or other tissue. Upon completion of a surgical procedure, cement delivery system <NUM> may be removed from device <NUM>, and driver <NUM> is removed from the surgical site. In some embodiments, device <NUM> is disengaged and/or disconnected from driver <NUM> either before or after driver <NUM> is removed from the surgical site. In some embodiments, a spinal construct, such as, for example, a spinal rod is inserted into implant cavity <NUM> after driver <NUM> is removed from the surgical site and a setscrew is engaged with receiver <NUM> such that threads on an outer surface of the setscrew engage the threads on the inner surfaces of arms <NUM>, <NUM>. The setscrew is rotated relative to receiver <NUM> until the setscrew engages the rod to fix the rod relative to receiver <NUM>.

Delivery system <NUM> can include one or a plurality of bone fasteners such as those described herein and/or fixation elements, which may be employed with a single vertebral level or a plurality of vertebral levels. In some embodiments, the bone fasteners may be engaged with vertebrae in various orientations, such as, for example, series, parallel, offset, staggered and/or alternate vertebral levels. In some embodiments, the bone fasteners and/or fixation elements may include one or a plurality of multi-axial screws, sagittal angulation screws, pedicle screws, mono-axial screws, uni-planar screws, fixed screws, tissue penetrating screws, conventional screws, expanding screws, wedges, anchors, buttons, clips, snaps, friction fittings, compressive fittings, expanding rivets, staples, nails, adhesives, posts, fixation plates and/or posts. In some embodiments, system <NUM> may comprise various instruments including the configuration 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.

In some embodiments, delivery system <NUM> includes an agent, which may be disposed, packed, coated or layered within, on or about the components and/or surfaces of delivery system <NUM>. In some embodiments, the agent may include bone growth promoting material, such as, for example, bone graft to enhance fixation of the fixation elements with vertebrae. The components of delivery system <NUM> can be made of radiolucent materials such as polymers. Radiomarkers may be included for identification under x-ray, fluoroscopy, CT or other imaging techniques. In some embodiments, the agent may include one or a plurality of therapeutic agents and/or pharmacological agents for release, including sustained release, to treat, for example, pain, inflammation and degeneration.

In one embodiment, shown in <FIG>, delivery system <NUM> includes a driver <NUM> that is similar to driver <NUM>. Driver <NUM> includes an outer sleeve <NUM> having a lower portion <NUM> and an upper portion <NUM> that is connected with lower portion <NUM>. Lower portion <NUM> extends along a longitudinal axis L3 between an end <NUM> and an opposite end <NUM>. End <NUM> includes a circumferential cutout <NUM> configured for disposal of an end <NUM> of upper portion <NUM> to connect upper portion <NUM> with lower portion <NUM>. In some embodiments, upper portion <NUM> is connected with lower portion <NUM> to provisionally fix upper portion <NUM> relative to lower portion <NUM> such that rotation of upper portion <NUM> about axis L3 also rotates lower portion <NUM> about axis L3. In some embodiments, upper portion <NUM> can be variously connected with lower portion <NUM>, such as, for example, monolithic, integral connection, frictional engagement, threaded engagement, mutual grooves, screws, adhesive, nails, barbs and/or raised element. End <NUM> includes a tip <NUM> defining a drive portion configured for engagement with an implant, such as, for example, bone fastener <NUM>, as discussed herein. In some embodiments, the drive portion may include a square, triangular, polygonal, star or hexalobe cross sectional configuration configured engage a correspondingly shaped portion tool engaging portion <NUM> of fastener <NUM>.

Upper portion <NUM> includes an end <NUM> opposite end <NUM>. End <NUM> includes a first mating element, such as, for example, a flange <NUM> that is similar to flange <NUM>. Flange <NUM> is spaced apart from a flange <NUM> by an undercut, such as, for example, a recess <NUM>. Flange <NUM> includes opposite surfaces <NUM>, <NUM> that each extend perpendicular to axis L3 and surfaces <NUM>, <NUM> that are each positioned between surfaces <NUM>, <NUM>, as best shown in <FIG> and <FIG>. Surface <NUM> defines an end surface of end <NUM>. Surface <NUM> extends transverse to axis L3 and surface <NUM> extends parallel to axis L3.

Lower portion <NUM> includes an inner surface <NUM> defining a passageway <NUM> and upper portion <NUM> includes an inner surface <NUM> defining a channel <NUM> that is in communication and coaxial with passageway <NUM>. Passageway <NUM> and channel <NUM> are configured for disposal of an inner sleeve <NUM> such that sleeve <NUM> is rotatable relative to sleeve <NUM> about axis L3. Sleeve <NUM> includes an end <NUM> and an opposite end <NUM> having a threaded outer surface <NUM>. A distal portion of end <NUM> is positioned in passageway <NUM> and a proximal portion <NUM> of end <NUM> is positioned in channel <NUM>. Proximal portion <NUM> includes an inner surface <NUM> defining a socket <NUM>. In some embodiments, socket <NUM> may include a square, triangular, polygonal, star or hexalobe cross sectional configuration configured engage a correspondingly shaped portion of a thumbwheel <NUM>, as discussed herein.

Upper portion <NUM> includes a window <NUM> that is configured to allow visualization of a portion of device <NUM> and a window <NUM> that is configured to allow grasping of thumbwheel <NUM>. Thumbwheel <NUM> includes a bit (not shown) disposed in socket <NUM>. The bit has a shape that corresponds to the shape of socket <NUM> such that rotation of thumbwheel <NUM> relative to sleeve <NUM> about axis L3 also rotates sleeve <NUM> relative to sleeve <NUM> about axis L3.

To connect driver <NUM> with fastener <NUM>, thumbwheel <NUM> is rotated relative to sleeve <NUM> about axis L3 in a first rotational direction, such as, for example clockwise or counterclockwise. Rotation of thumbwheel <NUM> relative to sleeve <NUM> about axis L3 in the first rotational direction causes rotation of sleeve <NUM> relative to sleeve <NUM> about axis L3 in the first rotational direction. As sleeve <NUM> rotates relative to sleeve <NUM> about axis L3 in the first rotational direction, the threads on surface <NUM> of sleeve <NUM> mate with the threads on the inner surfaces of arms <NUM>, <NUM> of fastener <NUM>. Further rotation of sleeve <NUM> relative to sleeve <NUM> about axis L3 in the first rotational direction causes sleeve <NUM> to translate axially relative to sleeve <NUM> in the direction shown by arrow F in <FIG>. As sleeve <NUM> translates axially relative to sleeve <NUM> in the direction shown by arrow F in <FIG>, tip <NUM> is inserted into tool engaging portion <NUM> of screw <NUM>. Simultaneous engagement of tip <NUM> with tool engaging portion <NUM> and the threads on surface <NUM> of sleeve <NUM> with the threads on the inner surfaces of arms <NUM>, <NUM> of fastener <NUM> prevents screw <NUM> from pivoting relative to receiver <NUM>.

To remove driver <NUM> from fastener <NUM>, thumbwheel <NUM> is rotated relative to sleeve <NUM> about axis L3 in an opposite second rotational direction, such as, for example clockwise or counterclockwise. Rotation of thumbwheel <NUM> relative to sleeve <NUM> about axis L3 in the second rotational direction causes rotation of sleeve <NUM> relative to sleeve <NUM> about axis L3 in the second rotational direction. As sleeve <NUM> rotates relative to sleeve <NUM> about axis L3 in the second rotational direction, sleeve <NUM> translates axially relative to sleeve <NUM> in the direction shown by arrow G in <FIG>. As sleeve <NUM> translates axially relative to sleeve <NUM> in the direction shown by arrow G in <FIG>, tip <NUM> moves out of tool engaging portion <NUM> of screw <NUM> and the threads on surface <NUM> of sleeve <NUM> disengage the threads on the inner surfaces of arms <NUM>, <NUM> of fastener <NUM>, at which point driver <NUM> can be fully removed from fastener <NUM>.

In assembly, operation and use, driver <NUM> is connected with fastener <NUM> as discussed herein. Access to the surgical site is obtained and the particular surgical procedure is performed. The components of delivery system <NUM> are employed to augment the surgical treatment. For example, fastener <NUM> may be inserted into bone or other tissue with driver <NUM>, for example via clockwise or counterclockwise rotation of sleeve <NUM>.

Device <NUM> is connected with driver <NUM> either before or after fastener <NUM> is inserted into bone or other tissue. To connect device <NUM> with driver <NUM>, shaft <NUM> is inserted into channel <NUM> such that axis L3 is coaxial with axis L1. Device <NUM> is then translated axially relative to sleeve <NUM> in the direction shown by arrow F in <FIG> until shaft <NUM> extends through thumbwheel <NUM> and conical portion <NUM> is positioned within channel <NUM>. As device <NUM> translates axially relative to sleeve <NUM> in the direction shown by arrow F in <FIG>, surface 150a of tab <NUM> slides along surface <NUM> of flange <NUM> and surface 156a of tab <NUM> slides along surface <NUM>. As surfaces 150a, 156a slide along surface <NUM>, wings <NUM>, <NUM> deflect outwardly from body <NUM> such that the distance between surfaces 150a, 156a increase from the first distance to the second distance. Device <NUM> is further translated axially relative to sleeve <NUM> in the direction shown by arrow F in <FIG> when surfaces 150a, 156a are spaced apart by the second distance such that surfaces 150a, 156a slide along surface <NUM> of flange <NUM>. Device <NUM> is further translated axially relative to sleeve <NUM> in the direction shown by arrow F in <FIG> such that tabs <NUM>, <NUM> are aligned with recess <NUM>. The inward bias of wings <NUM>, <NUM> causes tabs <NUM>, <NUM> to move toward one another such that surface 150a is spaced the first distance apart from surface 156a and surfaces 150b, 156b engage surface <NUM> of flange <NUM>, as shown in <FIG> to prevent device <NUM> from translating axially relative to sleeve <NUM> in the direction shown by arrow G in <FIG>. In some embodiments, tabs <NUM>, <NUM> create a clicking sound when tabs <NUM>, <NUM> to move toward one another and surfaces 150b, 156b engage surface <NUM> of flange <NUM>, which indicates the device <NUM> is properly assembled with sleeve <NUM>.

In one embodiment, bone filler material, such as, for example, bone cement is inserted through opening <NUM> and into lumen <NUM>. The bone filler material may be inserted into lumen <NUM> after device <NUM> is connected with driver <NUM>. Plunger <NUM> is aligned with opening <NUM>. Plunger <NUM> is then translated relative to handle <NUM> in the direction shown by arrow F in <FIG> such that plunger <NUM> pushes the bone filler material through lumen <NUM>, an aperture <NUM> that extends through tip <NUM> and bore <NUM> such that the bone filler material exits screw <NUM> via one or more openings in screw <NUM>. As the bone filler material cures, it will bond screw <NUM> with bone or other tissue. Upon completion of a surgical procedure, plunger <NUM> may be removed from device <NUM>, and driver <NUM> is removed from the surgical site. In some embodiments, device <NUM> is disengaged from driver <NUM> either before or after driver <NUM> is removed from the surgical site. To remove device <NUM> from sleeve <NUM>, a force is applied to gripping portion <NUM> to move gripping portion <NUM> relative to body <NUM> in the direction shown by arrow B in <FIG> and a force is applied to gripping portion <NUM> to move gripping portion <NUM> relative to body <NUM> in the direction shown by arrow C in <FIG> such that surface 150a is spaced the second distance apart from surface 156a. Device <NUM> is translated axially relative to sleeve <NUM> in the direction shown by arrow F in <FIG> such that surfaces 150a, 156a slide along surface <NUM>. Device <NUM> may be translated axially relative to sleeve <NUM> in the direction shown by arrow F in <FIG> until shaft <NUM> is removed from channel <NUM>. In some embodiments, a spinal construct, such as, for example, a spinal rod is inserted into implant cavity <NUM> after driver <NUM> is removed from the surgical site and a setscrew is engaged with receiver <NUM> such that threads on an outer surface of the setscrew engage the threads on the inner surfaces of arms <NUM>, <NUM>. The setscrew is rotated relative to receiver <NUM> until the setscrew engages the rod such that the rod is fixed relative to receiver <NUM>.

In one embodiment, threads of luer lock <NUM> are mated with threads of surface <NUM> to connect cartridge <NUM> to handle <NUM>. Cartridge <NUM> is loaded with a bone filler material, such as, for example, bone cement either before or after cartridge <NUM> is connected to handle <NUM>. The trigger handle of cement delivery gun <NUM> is activated to move the bone filler material through lumen <NUM>, aperture <NUM> and bore <NUM> such that the bone filler material exits screw <NUM> via one or more openings in screw <NUM>. As the bone filler material cures, it will bond screw <NUM> with bone or other tissue. Upon completion of a surgical procedure, cement delivery system <NUM> may be removed from device <NUM>, and driver <NUM> is removed from the surgical site. In some embodiments, device <NUM> is disengaged from driver <NUM> either before or after driver <NUM> is removed from the surgical site. In some embodiments, a spinal construct, such as, for example, a spinal rod is inserted into implant cavity <NUM> after driver <NUM> is removed from the surgical site and a setscrew is engaged with receiver <NUM> such that threads on an outer surface of the setscrew engage the threads on the inner surfaces of arms <NUM>, <NUM>. The setscrew is rotated relative to receiver <NUM> until the setscrew engages the rod such that the rod is fixed relative to receiver <NUM>.

Claim 1:
A delivery system (<NUM>) for treating spine disorders comprising:
a first instrument (<NUM>, <NUM>) comprising an outer sleeve (<NUM>, <NUM>) that extends along a longitudinal axis (L1, L3) defining a passageway (<NUM>, <NUM>), and an inner sleeve (<NUM>, <NUM>) coaxial with the axis (L1, L3) having a first end (<NUM>, <NUM>) disposed in the passageway (<NUM>, <NUM>) and a second end (<NUM>, <NUM>) including a first mating element (<NUM>, <NUM>), the inner sleeve (<NUM>) defining a channel (<NUM>) coaxial with the axis (L1) and extends the entire length of the inner sleeve (<NUM>); and
a second instrument (<NUM>) comprising a hollow shaft (<NUM>) disposed in the channel (<NUM>) and extends along a longitudinal axis (L2) and a handle (<NUM>) coupled to the shaft (<NUM>), the handle (<NUM>) comprising a body (<NUM>) that is coaxial with the shaft (<NUM>) and the axis (L2), and a second mating element (<NUM>, <NUM>) extending from the body (<NUM>), the second mating element (<NUM>, <NUM>) being configured to engage the first mating element (<NUM>) to secure the second instrument (<NUM>) to the first instrument (<NUM>) such that the axis (L2) is coaxial with the axis (L1, L3),
wherein the second mating element (<NUM>, <NUM>) includes a first wing (<NUM>) that extends from a first side (<NUM>) of the body (<NUM>) in a cantilevered configuration, and a second wing (<NUM>) that extends from an opposite second side (<NUM>) of the body (<NUM>) in a cantilevered configuration;
wherein the first wing (<NUM>) comprises a first extension (<NUM>) that extends parallel to the longitudinal axis (L2) from the first side (<NUM>), a first gripping portion (<NUM>) that extends transverse to the longitudinal axis (L2) from the first extension (<NUM>) and a first tab (<NUM>) that extends perpendicular to the longitudinal axis (L2) from the first extension (<NUM>); and
wherein the second wing (<NUM>) comprises a second extension (<NUM>) that extends parallel to the longitudinal axis (L2) from the second side (<NUM>), a second gripping portion (<NUM>) that extends transverse to the longitudinal axis (L2) from the second extension (<NUM>) and a second tab (<NUM>) that extends perpendicular to the longitudinal axis (L2) from the second extension (<NUM>).