Patent Description:
The present disclosure generally relates to medical devices and methods for the treatment of musculoskeletal disorders (methods are not claimed)) and more particularly to a spinal implant.

Spinal disorders such as degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, 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 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 fusion, fixation, corpectomy, discectomy, laminectomy and implantable prosthetics. In procedures, such as, for example, corpectomy and discectomy, fusion and fixation treatments may be performed that employ implants, such as, for example, expandable cages to restore the mechanical support function of vertebrae. The expandable cages may be packed with bone graft to promote fusion. The current method for packing bone graft into an expandable cage is a two-step process. First, the cage is pre-packed on the back table by the surgeon or sometimes by the assistant. Second, once the cage is inserted, expanded and locked into its final position, the surgeon will post-pack the cage in-situ. Depending on the system, there are different options for post-packing including funnels, syringes, or transferring the graft using a pick-up tool and packing it tight with a bone tamp. This process can be both time consuming and frustrating, as it can be difficult to cram either small pieces of bone or messy allograft through small holes. This disclosure describes an improvement over these prior art technologies.

Further, <CIT> discloses a spinal implant according to the preamble of claim <NUM> and systems and methods of use thereof. In <CIT>, the spinal implant has a first member defining a longitudinal axis, a second member includes an axial cavity configured for disposal of the first member, a third member is rotatable relative to the first member and defines a transverse cavity, and a locking element is disposable in the transverse cavity and engageable with the first member to fix the third member relative to the first member.

In addition, <CIT> discloses a spinal implant and systems and methods of use thereof, wherein the spinal implant includes a first member having a wall that defines an axial cavity, a second member extends between a first end and a second end and defines a longitudinal axis, the second member is configured for disposal with the axial cavity and translation relative to the first member, a third member has an outer surface engageable with tissue and an inner surface disposed to dynamically engage the first end in response to the engagement of the outer surface with the tissue.

In view of the foregoing and to provide the desired improvement over these prior art technologies, the present invention is set out in the appended set of claims and provides a spinal implant according to claim <NUM>. Further advantageous embodiments are described in the dependent claims.

The methods described herein are not embodiments according to the invention, but are present for illustration purposes only.

The exemplary embodiments of the surgical system and related methods of use disclosed are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a surgical system that includes a spinal implant and a method for treating a spine.

A method for pre-packing and post-packing an implant, such as, for example, an expandable cage all at one time with little to no hassle is provided. The method includes using new types of allograft to provide an opportunity for a better delivery method. The cage includes a port of a specific diameter that matches perfectly with the design of a tip of a syringe, funnel, or other delivery device. The cage can be completely filled at one time in both the current pre and post-packing cavities. It would also ensure that the graft is pressed up tight against the endplates, providing a better chance of fusion. This greatly reduces the number of steps the surgeon would perform at the end of the procedure, which would encourage the use of a biologic product that could be pre-loaded or easily loaded into the delivery device on the back table.

In one embodiment, the present system includes a spinal implant including an endcap that aligns a lock for fixation with the spinal implant. In one embodiment, the present system includes an articulating endcap in a corpectomy device and/or vertebral body replacement device configured to align a locking element, such as, for example, a set screw for fixation in a selected orientation. In one embodiment, the alignment of the set screw facilitates locking in situ. In one embodiment, the set screw is oriented perpendicular to or slightly offset from the front of the implant to facilitate locking of the endcap along an approach utilized for implantation. In some embodiments, the spinal implant is expandable.

In one embodiment, the endcap includes a cavity configured to align a set screw such that a tip of the set screw contacts a spherical cut of a post of a spinal implant, which allows for articulation. In some embodiments, the endcap is oriented to an angle relative to a longitudinal axis of the post such that the cavity is configured to orient the set screw at an angle relative to the longitudinal axis. In some embodiments, the angle corresponds to an initial starting position, for example, such that the endcap is positioned perpendicular to the post. In some embodiments, the angulation of the set screw facilitates insertion of the set screw when the endcap is in a fully tilted position. In some embodiments, the angulation of the cavity provides access to the cavity such that the set screw is positioned perpendicular to the post. In some embodiments, angulation of the cavity and tilting of the endcap positions the set screw parallel to the vertebral endplate facilitating access to the set screw.

In one embodiment, the spinal implant comprises a post including a stepped configuration, such as, for example, a wedding cake configuration at a first end. In some embodiments, the stepped configuration provides for smoother articulation. In one embodiment, providing the stepped configuration on a post results in a significant reduction in cost in both manufacturing and inspection. In one embodiment, the step configuration is configured to engage an underside surface of the endcap to facilitate fixation of the endcap with the post.

In one embodiment, the spinal implant includes an anti-back out portion to prevent the set screw from fully backing out. In one embodiment, the cavity of the end cap includes a staked thread configured to prevent back out. In some embodiments, the staked thread allows the set screw to back out sufficiently to unlock the endcap while preventing the endcap from disengaging from the post.

In one embodiment, the spinal implant comprises an endcap including a counter bore within the set screw cavity. In some embodiments, the spinal implant is assembled with a method such that the set screw is assembled from the inside of the post and backed out until it reaches a thread-stop. In some embodiments, the method includes the step of staking for deforming an end of the counter-bore to prevent over advancing the set screw. In some embodiments, when the set screw is in the fully backed out position, the ring and post have clearance to be assembled.

In one embodiment, the spinal implant has torsion slots configured to prevent an instrument, such as, for example, an inserter from being undesirably attached to the spinal implant, for example, upside down. In some embodiments, the spinal implant allows a jaw-like connection with the inserter and provides a rigid engagement.

In some embodiments, the present disclosure may be employed to treat spinal disorders such as, for example, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor and fractures. In some embodiments, 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 spinal implant 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 present disclosure may also be alternatively employed with procedures for treating the lumbar, cervical, thoracic, sacral and pelvic regions of a spinal column. The spinal implant 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 present disclosure may be understood more readily by reference to the following detailed description of the embodiments taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this application is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting. Also, in some embodiments, as used in the specification and including the appended claims, the singular forms "a," "an," and "the" 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 from "about" or "approximately" one particular value and/or to "about" or "approximately" another particular value. Similarly, when values are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another embodiment. It is also understood that all spatial references, such as, for example, horizontal, vertical, top, upper, lower, bottom, left and right, are for illustrative purposes only and can be varied within the scope of the disclosure. For example, the references "upper" and "lower" are relative and used only in the context to the other, and are not necessarily "superior" and "inferior".

As used in the specification and including the appended claims, "treating" or "treatment" of a disease or condition refers to performing a procedure (not claimed) that may include administering one or more drugs to a patient (human, normal or otherwise other mammal), employing implantable devices, and/or employing instruments that treat the disease, such as, for example, micro-discectomy instruments used to remove portions bulging or herniated discs and/or bone spurs, in an effort to alleviate signs or symptoms of the disease or condition. Alleviation can occur prior to signs or symptoms of the disease or condition appearing, as well as after their appearance. Thus, treating or treatment includes preventing or prevention of disease or undesirable condition (e.g., preventing the disease from occurring in a patient, who may be predisposed to the disease but has not yet been diagnosed as having it). In addition, treating or treatment does not require complete alleviation of signs or symptoms, does not require a cure, and specifically includes procedures that have only a marginal effect on the patient. Treatment can include inhibiting the disease, e.g., arresting its development, or relieving the disease, e.g., causing regression of the disease. For example, treatment can include reducing acute or chronic inflammation; alleviating pain and mitigating and inducing re-growth of new ligament, bone and other tissues; as an adjunct in surgery; and/or any repair procedure. Also, as used in the specification and including the appended claims, the term "tissue" includes soft tissue, ligaments, tendons, cartilage and/or bone unless specifically referred to otherwise.

The following discussion includes a description of a surgical system including a spinal implant, related components and methods of employing the surgical 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 surgical system, such as, for example, a spinal implant system <NUM> including a spinal implant <NUM>.

For example, the components of spinal implant system <NUM>, individually or collectively, can be fabricated from materials such as stainless steel alloys, commercially pure titanium, titanium alloys, Grade <NUM> titanium, superelastic titanium alloys, cobalt-chrome alloys, stainless steel alloys, superelastic metallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL® manufactured by Toyota Material Incorporated of Japan), ceramics and composites thereof such as calcium phosphate (e.g., SKELITE™ manufactured by Biologix Inc. ), 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.

Spinal implant system <NUM> is employed, for example, with a minimally invasive procedure, including percutaneous techniques, mini-open and open surgical techniques to deliver and introduce instrumentation and/or an implant, such as, for example, a corpectomy implant, at a surgical site within a body of a patient, for example, a section of a spine. In some embodiments, spinal implant system <NUM> may be employed with surgical procedures, such as, for example, corpectomy and discectomy, which include fusion and/or fixation treatments that employ implants to restore the mechanical support function of vertebrae.

Spinal implant system <NUM> includes a vertebral body replacement implant <NUM> including a member, such as, for example, an inner body <NUM>. Body <NUM> has a tubular configuration and is oriented for disposal within an axial channel, such as, for example, an axial cavity <NUM>, as described herein. Body <NUM> defines a longitudinal axis A1. Body <NUM> extends between an end <NUM> and an end <NUM>, as shown in <FIG>. Body <NUM> includes a wall, such as, for example, a tubular wall <NUM>. In some embodiments, wall <NUM> has a cylindrical cross-section and an outer surface <NUM>. In some embodiments, the cross-sectional geometry of wall <NUM> may have various configurations, such as, for example, round, oval, oblong, triangular, polygonal having planar or arcuate side portions, irregular, uniform, non-uniform, consistent, variable, horseshoe shape, U-shape or kidney bean shape. In some embodiments, outer surface <NUM> may be smooth, even, rough, textured, porous, semi-porous, dimpled and/or polished.

Wall <NUM> includes an axial opening, such as, for example, an axial slot <NUM>. Slot <NUM> has a substantially rectangular configuration to facilitate axial translation of body <NUM> relative to a member, such as, for example, an outer body <NUM>, as described herein. In some embodiments, slot <NUM> may have various configurations, such as, for example, arcuate, oval, oblong, triangular, polygonal having planar or arcuate side portions, irregular, uniform or non-uniform. Slot <NUM> includes a gear rack <NUM> having a plurality of teeth <NUM> that are disposed therealong. Teeth <NUM> are engageable with a surgical instrument to facilitate expansion and/or contraction of implant <NUM>, as described herein. For example, in some embodiments, the expansion mechanism for spinal implant <NUM> may comprise that which is disclosed in <CIT>, published as <CIT>.

A portion of outer surface <NUM> comprises a helical gear <NUM> having a plurality of teeth <NUM> engageable with a band <NUM> to facilitate locking the height of implant <NUM>. Teeth <NUM> are spaced apart in a helical configuration and disposed at an angular orientation relative to axis A1 such that band <NUM> is translatable in a helical gear configuration about surface <NUM>. In some embodiments, the components of implant <NUM> may translate to expand and/or contract implant <NUM> via engagement of the bodies without a band configuration. For example, in some such embodiments, band <NUM> may comprise a locking ring configured to rotate about surface <NUM> as a separate instrument is engaged with slot <NUM>, which includes a gear rack <NUM> having a plurality of teeth <NUM> that are disposed therealong. Teeth <NUM> are engageable with a surgical instrument to facilitate expansion and/or contraction of implant <NUM> until a user locks the height of implant <NUM>, using setscrew <NUM>, which is provided to fix body <NUM> relative to body <NUM> by locking the helical position of band <NUM> along surface <NUM>.

In some embodiments, a portion of outer surface <NUM> at end <NUM> includes a decreasing dimension d or taper, as shown in <FIG>. End <NUM> includes a plurality of steps <NUM> disposed along axis A1. Steps <NUM> are configured for engagement with a member, such as, for example, a cap <NUM> to provide selective positioning of cap <NUM> and to facilitate rotation of cap <NUM> relative to axis A1 and body <NUM>. In some embodiments, end <NUM> includes one or a plurality of steps <NUM>. In some embodiments, end <NUM> can include a surface that may be smooth, rough, textured, porous, semi-porous, dimpled and/or polished to facilitate engagement with cap <NUM>.

Surface <NUM> includes a wall <NUM> and a wall <NUM> that define a cavity <NUM>, as shown in <FIG>. Walls <NUM>, <NUM> define movable limits of a flange <NUM> of cap <NUM>. Flange <NUM> is rotatable relative to axis A1 and body <NUM> between a first angular limit provided by wall <NUM> and a second angular limit provided by wall <NUM>, as described herein. Cap <NUM> is rotatable relative to axis A1 and body <NUM> between the movable limits to facilitate positioning of implant <NUM> for delivery and/or with tissue, and access to implant <NUM> for surgical instrument engagement and locking, as well as avoiding disassembly of the components of implant <NUM> during insertion with tissue. In one embodiment, the moveable limit includes a plurality of limits, each limit corresponding to one of a plurality of orientations of cap <NUM> relative to body <NUM>.

Surface <NUM> includes an engagement surface, such as, for example, spherical surface <NUM>. In some embodiments, surface <NUM> is recessed from surface <NUM> within a circumferential wall <NUM>. In some embodiments, surface <NUM> is flush with surface <NUM>. In some embodiments, surface <NUM> is raised from surface <NUM>. Surface <NUM> is configured for engagement with a locking element, such as, for example, a set screw <NUM> to fix cap <NUM> relative to body <NUM> in a selected orientation, as described herein.

In some embodiments, body <NUM> includes an inner surface <NUM> opposite surface <NUM>. Surface <NUM> defines an axial passageway <NUM> that is coaxial with axis A1, as shown in <FIG> and <FIG>, for example. Body <NUM> includes an opening <NUM> that extends through an end surface <NUM> of body <NUM> and an opening <NUM> that extends through an opposite end surface <NUM> of body. Openings <NUM>, <NUM> are in communication with passageway <NUM>. Passageway <NUM> is spaced apart from slot <NUM> by wall <NUM>. Wall <NUM> includes one or a plurality of ports, such as, for example, one or a plurality of openings <NUM> that extend through a thickness of wall <NUM>. Openings <NUM> are each in communication with slot <NUM> and passageway <NUM>. In some embodiments, body <NUM> includes one or a plurality of ports, such as, for example, openings 162a that are each in communication with passageway <NUM>. In some embodiments, at least one of openings 162a is aligned and/or coaxial with one of openings <NUM>, as shown in <FIG> and <FIG>, for example. In some embodiments, passageway <NUM> may be disposed at alternate orientations, relative to axis A1, 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, openings 162a may be disposed at alternate orientations, relative to one of openings <NUM>, 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.

Openings <NUM>, 162a are configured for disposal of a tip <NUM> of a delivery instrument, such as, for example, a funnel or a syringe <NUM> (<FIG>) to deliver bone graft into passageway <NUM>, as discussed herein. In some embodiments, openings <NUM>, 162a have a specific size and/or shape that matches the size or shape of tip <NUM>. For example, when tip <NUM> has a circular cross-sectional configuration, openings <NUM>, 162a can have a circular cross-sectional configuration with a diameter of tip <NUM> being slightly less than diameters of openings <NUM>, 162a to allow tip <NUM> to be positioned in openings <NUM>, 162a. Likewise, when tip <NUM> has a polygonal cross-sectional configuration, openings <NUM>, 162a can have a polygonal cross-sectional configuration with a diameter of tip <NUM> being slightly less than diameters of openings <NUM>, 162a to allow tip <NUM> to be positioned in openings <NUM>, 162a. In some embodiments, an outer surface of tip <NUM> directly engages surfaces that define openings <NUM>, 162a when tip <NUM> is inserted into openings <NUM>, 162a such that tip <NUM> forms a friction or interference fit with body <NUM>. In some embodiments, the outer surface of tip <NUM> is spaced apart from surfaces that define openings <NUM>, 162a when tip <NUM> is inserted into openings <NUM>, 162a. In some embodiments, openings <NUM>, 162a and tip <NUM> can have various shape configurations, such as, for example, oval, oblong, polygonal, irregular, uniform, non-uniform, variable and/or tapered.

Cap <NUM> includes an outer surface <NUM> and an inner surface <NUM>. Surface <NUM> is configured for engagement with tissue. Surface <NUM> includes a surface <NUM>, which includes planar and dimpled portions for engagement with tissue, and defines an axis A2 oriented transverse to axis A1, as shown in <FIG>. In some embodiments, surface <NUM> and/or axis A2 may be disposed in transverse orientations relative to axis A1, such as, for example, perpendicular and/or other angular orientations such as acute or obtuse, and/or may be offset or staggered. In some embodiments, surface <NUM> can include a surface that may be rough, textured, porous, semi-porous, dimpled and/or polished to facilitate engagement with tissue. In some embodiments, surface <NUM> can include one or more openings to deliver an agent, such as, for example, bone graft to a vertebra endplate.

Surface <NUM> includes a substantially planar surface <NUM>, an angled surface <NUM> and annular surfaces <NUM>, <NUM>, a shown in <FIG>. Angled surface <NUM> is disposed circumferentially about cap <NUM>. Surfaces <NUM>, <NUM>, <NUM>, <NUM> are configured for engagement with steps <NUM> and/or surface <NUM> to facilitate rotation of cap <NUM> relative to axis A1 and body <NUM>, as described herein. Apices of annular surfaces <NUM>, <NUM> may be offset at an angle (ranging from <NUM> to <NUM> degrees) relative to axis A2, as shown generally in <FIG>, to allow for a larger freedom of motion for cap <NUM>.

Cap <NUM> is rotatable about body <NUM> such that surface <NUM> and/or axis A2 may be disposed in one or a plurality of transverse orientations and at one or a plurality of angular orientations α relative to axis A1, as shown in <FIG>. In some embodiments, surface <NUM> and/or axis A2 are moveable relative to axis A1 between a first orientation such that surface <NUM> and/or axis A2 of cap <NUM> is disposed at an angle α1 relative to axis A1, as shown in <FIG>, and a second orientation such that surface <NUM> and/or axis A2 of cap <NUM> is disposed at a selected angle α2 relative to axis A1, as shown in <FIG>.

In some embodiments, angle α1 is <NUM> degrees. In some embodiments, surface <NUM> and/or axis A2 are moveable relative to axis A1 through an angular range of +/- <NUM> degrees. In some embodiments, in a first orientation, angle α1 is substantially <NUM> degrees and surface <NUM> and/or axis A2 are moveable relative to axis A1 to a second orientation such that angle α2 equals angle α1 plus an angle within an angular range of +/- <NUM> degrees. In some embodiments, cap <NUM> is moveable relative to axis A1 in one or more planes of a body, such as, for example, vertical, horizontal, diagonal, bi-lateral, transverse, coronal and/or sagittal planes of a body.

Cap <NUM> includes flange <NUM> configured for movable disposal with cavity <NUM> and engagement with walls <NUM>, <NUM>. Flange <NUM> extends from surface <NUM> and is oriented towards body <NUM>, as shown in <FIG>. Cap <NUM> includes a cavity <NUM> that defines an axis A3 disposed transverse to axes A1, A2, as shown in <FIG>. Axis A3 is offset from axis A1 in a selected plane, as shown in <FIG>.

Cavity <NUM> is configured to orient set screw <NUM> transverse, such as, for example, perpendicular and/or offset from axis A1 upon rotation of cap <NUM> to facilitate engagement of set screw <NUM> with surface <NUM>. In some embodiments, cavity <NUM> orients set screw <NUM> for engagement with surface <NUM> to lock cap <NUM> with body <NUM> along the same surgical passageway utilized to insert implant <NUM> with tissue, as described herein.

Axis A3 is disposed at a fixed orientation at an angle γ relative to axis A2. In some embodiments, axis A3 is disposed at an angle γ of <NUM> degrees relative to axis A2. In some embodiments, axis A3 is moveable relative to axis A1 between a first orientation such that axis A3 is disposed at an angle β1 relative to axis A1, as shown in <FIG> and <FIG>, and a second orientation such that axis A3 is disposed at a selected angle β2 relative to axis A1, as shown in <FIG>. In the second orientation, β2 approaches substantially <NUM> degrees and/or a perpendicular orientation of axis A3 relative to axis A1 to facilitate engagement of set screw <NUM> with surface <NUM>. In some embodiments, axis A3 is moveable relative to axis A1 in one or more planes of a body, such as, for example, vertical, horizontal, diagonal, bi-lateral, transverse, coronal and/or sagittal planes of a body.

Cavity <NUM> includes a threaded surface <NUM> configured for engagement with set screw <NUM>. In one embodiment, as shown in <FIG>, cavity <NUM> includes an end thread <NUM>. Thread <NUM> prevents set screw <NUM> from fully backing out of cap <NUM>, as described herein. In one embodiment, setscrew <NUM> is threaded into cavity <NUM> until set screw <NUM> approaches thread <NUM>. For example, thread <NUM> may be staked such that proximal end <NUM> of thread <NUM> is deformed to prevent set screw <NUM> from fully backing out of cap <NUM>. Set screw <NUM> is positioned in cavity <NUM> to fix cap <NUM> relative to body <NUM> in a selected orientation, as described herein.

Body <NUM> includes a tubular configuration. Body <NUM> extends between an end <NUM> and an end <NUM>. Body <NUM> extends in a linear configuration. In some embodiments, body <NUM> may extend in alternate configurations, such as, for example, arcuate, offset, staggered and/or angled portions, which may include acute, perpendicular and obtuse. End <NUM> includes a surface that defines planar and dimpled portions for engagement with tissue. In some embodiments, end <NUM> can include a surface that may be rough, textured, porous, semi-porous, dimpled and/or polished such that it facilitates engagement with tissue. In some embodiments, the tissue comprises vertebral tissue, which may include intervertebral tissue, endplate surfaces, cancellous bone and/or cortical bone.

Body <NUM> includes a wall, such as, for example, a tubular wall <NUM>. Wall <NUM> includes an inner surface <NUM> that defines an axial cavity <NUM> extending between ends <NUM>, <NUM>. Body <NUM> is configured for disposal with cavity <NUM>. In some embodiments, wall <NUM> has a cylindrical cross-section. In some embodiments, the cross-section geometry of wall <NUM> may include, such as, for example, round, oval, oblong, triangular, polygonal having planar or arcuate side portions, irregular, uniform, non-uniform, consistent, variable, horseshoe shape, U-shape or kidney bean shape. In some embodiments, surface <NUM> is smooth or even. In some embodiments, surface <NUM> may be rough, textured, porous, semi-porous, dimpled and/or polished. In some embodiments, body <NUM> includes an opening <NUM> that extends through an end surface <NUM> of body <NUM> and an opening <NUM> that extends through an opposite end surface <NUM> of body <NUM>. Openings <NUM>, <NUM> are in communication with cavity <NUM>.

Wall <NUM> defines a port, such as, for example, lateral opening <NUM> that is in communication with cavity <NUM>. In some embodiments, opening <NUM> is configured for disposal of an instrument, such as, for example, an inserter utilized to facilitate expansion of body <NUM> relative to body <NUM>, as described herein. For example, opening <NUM> may be configured to receive a separate pinion instrument (not shown) adapted to engage gear rack <NUM>. The inserter instrument may, in some embodiments, comprise instruments disclosed in<CIT>.

In some embodiments, wall <NUM> defines openings <NUM>, <NUM> configured to receive an agent, which may include bone graft (not shown) and/or other materials, as described herein, for employment in a fixation or fusion treatment used for example, in connection with a corpectomy. In one embodiment, the agent may include therapeutic polynucleotides or polypeptides and bone growth promoting material, which can be packed, coated or otherwise disposed on or about the surfaces of the components of system <NUM>, including implant <NUM>. The agent may also include biocompatible materials, such as, for example, biocompatible metals and/or rigid polymers, such as, titanium elements, metal powders of titanium or titanium compositions, sterile bone materials, such as allograft or xenograft materials, synthetic bone materials such as coral and calcium compositions, such as hydroxyapatite, calcium phosphate and calcium sulfite, biologically active agents, for example, biologically active agents coated onto the exterior of implant <NUM> and/or applied thereto for gradual release such as by blending in a bioresorbable polymer that releases the biologically active agent or agents in an appropriate time dependent fashion as the polymer degrades within the patient. Suitable biologically active agents include, for example, bone morphogenic protein (BMP) and cytokines. In some embodiments, openings <NUM>, <NUM> can have various shape configurations, such as, for example, oval, oblong, polygonal, irregular, uniform, non-uniform, variable and/or tapered. In some embodiments, openings <NUM> are arranged in a row, with openings <NUM> each having an oblong shape or configuration, as shown in <FIG>, for example. In some embodiments, openings <NUM> are arranged in a column, with openings <NUM> each having a circular shape or configuration, as shown in <FIG>, for example.

Opening <NUM> is configured for disposal of a tip <NUM> of a delivery instrument, such as, for example, a funnel or a syringe <NUM> (<FIG>) to deliver bone graft into cavity <NUM>, as discussed herein. In some embodiments, opening <NUM> has a specific size and/or shape that matches the size or shape of tip <NUM>. For example, when tip <NUM> has a circular cross-sectional configuration, opening <NUM> can have a circular cross-sectional configuration with a diameter of tip <NUM> being slightly less than a diameter of opening <NUM> to allow tip <NUM> to be positioned in opening <NUM>. Likewise, when tip <NUM> has a polygonal cross-sectional configuration, opening <NUM> can have a polygonal cross-sectional configuration with a diameter of tip <NUM> being slightly less than diameters of opening <NUM> to allow tip <NUM> to be positioned in opening <NUM>. In some embodiments, an outer surface of tip <NUM> directly engages surfaces that define opening <NUM> when tip <NUM> is inserted into opening <NUM> such that tip <NUM> forms a friction or interference fit with body <NUM>. In some embodiments, the outer surface of tip <NUM> is spaced apart from surfaces that define opening <NUM> when tip <NUM> is inserted into opening <NUM>. In some embodiments, opening <NUM> and tip <NUM> can have various shape configurations, such as, for example, oval, oblong, polygonal, irregular, uniform, non-uniform, variable and/or tapered. In some embodiments, the tip of the syringe and mating hole on the implant form a ball and socket type connection to allow the syringe to engage with the hole in an off-axis orientation, increasing the ease of inserting graft through the hole.

In one embodiment, wall <NUM> includes cavities, such as, for example, slots <NUM> configured for attachment with a surgical inserter to prevent the inserter from being incorrectly attached, such as, for example, upside down. Wall <NUM> includes a cut out <NUM> configured to facilitate engagement with the inserter. Cutout <NUM> facilitates engagement of the inserter with body <NUM> by providing a rigid connection between the inserter and body <NUM>.

Surface <NUM> includes a portion <NUM>, as shown in <FIG>, which defines a circumferential cavity <NUM> disposed adjacent end <NUM>. Portion <NUM> has a substantially smooth or even surface configuration such that cavity <NUM> is configured for disposal of band <NUM>. Band <NUM> is slidably movable within cavity <NUM> for rotation relative to portion <NUM>. In some embodiments, portion <NUM> may be rough, textured, porous, semi-porous, dimpled and/or polished.

In one embodiment, body <NUM> includes a counter-bore <NUM>. In one embodiment, a setscrew <NUM> is provided to fix body <NUM> relative to body <NUM>. Set screw <NUM> includes a thread stop <NUM>, as shown in <FIG>. Set screw <NUM> is assembled from the inside of body <NUM> and backed out until set screw <NUM> approaches thread stop <NUM>. Counter-bore <NUM> is staked to deform an end of counter-bore <NUM> to prevent over advancing of setscrew <NUM> and facilitate assembly of body <NUM> and cap <NUM> with body <NUM>.

In operation, implant <NUM> is disposed in a first orientation, as shown in <FIG>, such that body <NUM> and body <NUM> are disposed in a telescopic arrangement for delivery and implantation adjacent a surgical site. Bodies <NUM>, <NUM> are seated such that substantially all of inner body <NUM> is disposed within outer body <NUM> in a nested configuration. Cap <NUM> is flush with end <NUM> such that axis A2 is substantially perpendicular to axis A1 and cavity <NUM> is disposed such that axis A3 is disposed transverse to axes A1, A2 and offset from axis A1. In the first orientation, a surgical inserter, which may comprise a rotatable pinion, is disposed within opening <NUM>, slots <NUM> and cutout <NUM> and engaged with gear rack <NUM> and actuated and/or rotated such that the inserter engages gear rack <NUM> for axial translation of body <NUM> relative to body <NUM>. Rotation of the inserter causes axial translation of body <NUM> relative to body <NUM> to expand implant <NUM>. In some embodiments, the inserter is rotated in the opposite direction to drive body <NUM> in a second axial direction and cause axial translation of body <NUM> relative to body <NUM> to contract and/or collapse implant <NUM> from an expanded configuration.

In some embodiments, in a second, expanded orientation, as shown in <FIG> for example, cap <NUM> and end <NUM> are disposed to engage adjacent vertebral soft tissue and bone surfaces, as will be described, to restore height and provide support in place of removed vertebrae and/or intervertebral tissue. In one embodiment, implant <NUM> is expanded to a second orientation at a selected amount of spacing and/or distraction between vertebrae such that cap <NUM> engages a first vertebral surface and end <NUM> engages a second vertebral surface to restore vertebral spacing and provide distraction and/or restore mechanical support function. In one embodiment, implant <NUM> is expanded, as discussed herein, progressively and/or gradually to provide an implant configured to adapt to the growth of a patient including the vertebrae. In some embodiments, the height of implant <NUM> may also be decreased over a period of time and/or several procedures to adapt to various conditions of a patient.

In some embodiments, as body <NUM> expands, as described herein, cap <NUM> rotates relative to axis A1 between a first orientation such that surface <NUM> and/or axis A2 of cap <NUM> are disposed at angle α1 relative to axis A1, as shown in <FIG>, and a second orientation such that surface <NUM> and/or axis A2 of cap <NUM> are disposed at selected angle α2 relative to axis A1, as shown in <FIG>. Rotation of cap <NUM> allows surface <NUM> to adjust to an angle to accommodate a specific angle of vertebral tissue, with tissue and/or a treatment. As cap <NUM> rotates, surfaces <NUM>, <NUM> translate about end <NUM> to accommodate the angle changes of surface <NUM>. Walls <NUM>, <NUM> provide a range of motion limit and resist and/or prevent cap <NUM> from rotating about axis A1 beyond a selected limitation of movement of cap <NUM>. The intersection between surfaces <NUM>, <NUM> contacts steps <NUM> to limit rotation of cap <NUM>.

Axis A3 maintains a fixed orientation at an angle γ relative to axis A2 during rotation of cap <NUM>. As cap <NUM> rotates, axis A3 is moveable relative to axis A1 between a first orientation such that axis A3 is disposed at an angle β1 relative to axis A1, as shown in <FIG> and <FIG>, and a second orientation such that axis A3 is disposed at a selected angle β2 relative to axis A1, as shown in <FIG>. In the second orientation, angle β2 approaches substantially <NUM> degrees and/or a perpendicular orientation of axis A3 relative to axis A1 to facilitate engagement of set screw <NUM> with surface <NUM> to fix cap <NUM> in a selected orientation relative to body <NUM> and/or body <NUM>.

In some embodiments, implant <NUM> provides a footprint that improves stability and decreases the risk of subsidence into tissue. In some embodiments, implant <NUM> provides height restoration between vertebral bodies, decompression, restoration of sagittal and/or coronal balance and/or resistance of subsidence into vertebral endplates.

Referring to <FIG>, in assembly, operation and use, spinal implant system <NUM> including implant <NUM>, similar to the systems and methods described with regard to <FIG>, is employed with a surgical procedure, such as, for example, a lumbar corpectomy for treatment of a spine of a patient including vertebrae V. Spinal implant system <NUM> may also be employed with other surgical procedures, such as, for example, discectomy, laminectomy, fusion, laminotomy, laminectomy, nerve root retraction, foramenotomy, facetectomy, decompression, spinal nucleus or disc replacement and bone graft and implantable prosthetics including plates, rods, and bone engaging fasteners for securement of implant <NUM> with vertebrae V.

Spinal implant system <NUM> is employed with a lumbar corpectomy including surgical arthrodesis, such as, for example, fusion to immobilize a joint for treatment of an applicable condition or injury of an affected section of a spinal column and adjacent areas within a body. For example, vertebrae V includes a vertebra V1 and a vertebra V2. A diseased and/or damaged vertebra and intervertebral discs are disposed between vertebrae V1, V2. In some embodiments, spinal implant system <NUM> is configured for insertion with a vertebral space to space apart articular joint surfaces, provide support and maximize stabilization of vertebrae V.

In use, to treat the affected section of vertebrae V, a medical practitioner obtains access to a surgical site including vertebrae V in any appropriate manner, such as through incision and retraction of tissues. In some embodiments, spinal implant system <NUM> may be used in any existing surgical method or technique including open surgery, mini-open surgery, minimally invasive surgery and percutaneous surgical implantation, whereby vertebrae V is accessed through a mini-incision, or sleeve that provides a protected passageway to the area. Once access to the surgical site is obtained, corpectomy is performed for treating the spine disorder. The diseased and/or damaged portion of vertebrae V, which may include diseased and/or damaged intervertebral discs, are removed to create a vertebral space S.

A preparation instrument (not shown) is employed to remove disc tissue, fluids, adjacent tissues and/or bone, and scrape and/or remove tissue from endplate surfaces E1 of vertebra V1 and/or endplate surface E2 of vertebra V2. Implant <NUM> is provided with at least one agent, similar to those described herein, to promote new bone growth and fusion to treat the affected section of vertebrae V.

Set screw <NUM> is engaged with cavity <NUM> from surface <NUM> of cap <NUM> and threaded into cavity <NUM> until set screw <NUM> approaches thread <NUM>, as described herein. Bodies <NUM>, <NUM> are seated such that substantially all of inner body <NUM> is disposed within outer body <NUM> in a nested configuration and cap <NUM> is flush with end <NUM> and axis A2 is disposed perpendicular to axis A1. The inserter is engaged with opening <NUM>, slots <NUM> and cutout <NUM>. Implant <NUM> is delivered to the surgical site adjacent vertebrae V along the surgical passageway. The inserter delivers implant <NUM> into prepared vertebral space S, between vertebrae V1, V2. Implant <NUM> is manipulated such that end <NUM> engages endplate surface E2. A gripping surface of end <NUM> penetrates and fixes with endplate surface E2. Implant <NUM> is positioned in a first orientation, as described herein, with endplate surface E2.

Rotation of the inserter causes axial translation of body <NUM> relative to body <NUM> to expand implant <NUM>, in a direction shown by arrow B in <FIG>. In one embodiment, the inserter is rotated in an opposite direction to drive body <NUM> in a second axial direction, as shown by arrow BB in <FIG>, and cause axial translation of body <NUM> relative to body <NUM> to contract and/or collapse implant <NUM> from the expanded configuration.

As the inserter is rotated, implant <NUM> expands to the second orientation, as shown in <FIG>. As such, implant <NUM> expands within vertebral space S and surface <NUM> engages endplate surface E1. Cap <NUM> rotates relative to axis A1, in the direction shown by arrow C in <FIG>, from the first orientation, such that surface <NUM> and/or axis A2 of cap <NUM> are disposed at angle α1 relative to axis A1, as shown in <FIG>, to the second orientation such that surface <NUM> and/or axis A2 of cap <NUM> are disposed at a selected angle α2 relative to axis A1, as shown in <FIG>.

Rotation of cap <NUM> allows surface <NUM> to adjust to an angle to accommodate a specific angle of endplate surface E1. As cap <NUM> rotates, axis A3 rotates from angle β1 relative to axis A1, as shown in <FIG> and <FIG>, to the second orientation such that axis A3 is disposed at the selected angle β2 relative to axis A1, as shown in <FIG>. In the second orientation β2 approaches the substantially perpendicular orientation relative to axis A1 to facilitate access along the surgical pathway to set screw <NUM> and engagement of set screw <NUM> with surface <NUM>. Set screw <NUM> is engaged with surface <NUM> to lock cap <NUM> relative to body <NUM> in a selected orientation, for example, such that surface <NUM> and/or axis A2 are disposed at a selected angle α2 relative to axis A1 and axis A3 is disposed at the selected angle β2 relative to axis A1.

Implant <NUM> engages and spaces apart opposing endplate surfaces E1, E2 and is secured within vertebral space S to stabilize and immobilize portions of vertebrae V in connection with bone growth for fusion and fixation of vertebrae V1, V2. Fixation of implant <NUM> with endplate surfaces E1, E2 may be facilitated by the resistance provided by the joint space and/or engagement with endplate surfaces E1, E2.

In some embodiments, implant <NUM> may engage only one endplate. In some embodiments, one or more agents, as described herein, may be applied to areas of the surgical site to promote bone growth. Components of system <NUM> including implant <NUM> can be delivered or implanted as a pre-assembled device or can be assembled in situ. Components of system <NUM> including implant <NUM> may be completely or partially revised, removed or replaced in situ. In some embodiments, one or all of the components of system <NUM> can be delivered to the surgical site via mechanical manipulation and/or a free hand technique.

In one embodiment, implant <NUM> may include fastening elements, which may include locking structure, configured for fixation with vertebrae V1, V2 to secure joint surfaces and provide complementary stabilization and immobilization to a vertebral region. In some embodiments, locking structure may include fastening elements such as, for example, rods, plates, clips, hooks, adhesives and/or flanges. In some embodiments, system <NUM> can be used with screws to enhance fixation. In some embodiments, system <NUM> and any screws and attachments may be coated with an agent, similar to those described herein, for enhanced bony fixation to a treated area. The components of 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 one embodiment, system <NUM> includes a plurality of implants <NUM>. In some embodiments, employing a plurality of implants <NUM> can optimize the amount vertebral space S can be spaced apart such that the joint spacing dimension can be preselected. The plurality of implants <NUM> can be oriented in a side by side engagement, spaced apart and/or staggered.

In some embodiments, the use of microsurgical and image guided technologies may be employed to access, view and repair spinal deterioration or damage, with the aid of system <NUM>. Upon completion of the procedure, the non-implanted components, surgical instruments and assemblies of system <NUM> are removed and the incision is closed.

In some embodiments, implant <NUM> is positioned in prepared vertebral space S between vertebrae V, as described herein, with implant <NUM> being free of agents, such as, for example, bone graft. That is, no agents are packed, coated or otherwise disposed on or about the surfaces of implant <NUM> when implant <NUM> is positioned between vertebrae V. Implant <NUM> may be positioned between vertebrae V such that surfaces <NUM>, <NUM> face endplate surface E1 of vertebra V1 and surfaces <NUM>, <NUM> face endplate surface E2 of vertebra V2.

In some embodiments, the inserter is rotated to cause axial translation of body <NUM> relative to body <NUM> to expand implant <NUM>, in a direction shown by arrow B in <FIG>. In one embodiment, the inserter is rotated in an opposite direction to drive body <NUM> in a second axial direction, as shown by arrow BB in <FIG>, and cause axial translation of body <NUM> relative to body <NUM> to contract and/or collapse implant <NUM> from the expanded configuration. In some embodiments, implant <NUM> may be contracted or expanded until implant <NUM> engages and spaces apart opposing endplate surfaces E1, E2 and is secured within vertebral space S to stabilize and immobilize portions of vertebrae V in connection with bone growth for fusion and fixation of vertebrae V1, V2. Fixation of implant <NUM> with endplate surfaces E1, E2 may be facilitated by the resistance provided by the joint space and/or engagement with endplate surfaces E1, E2. In some embodiments, implant <NUM> may engage only one of endplate surfaces E1, E2. Once implant <NUM> is manipulated to have a selected height, setscrew <NUM> is rotated to fix body <NUM> relative to body <NUM> to fix the height of implant <NUM> at the selected height.

After the height of implant <NUM> is fixed at the selected height, tip <NUM> of syringe <NUM> is inserted into opening <NUM>, as shown in <FIG>, and bone graft, such as, for example, autograft and/or allograft is injected through opening <NUM> and into cavity <NUM> using syringe <NUM> to at least partially fill cavity <NUM>. In some embodiments, bone graft is injected through opening <NUM> and into cavity <NUM> using syringe <NUM> to completely fill cavity <NUM>. In some embodiments, bone graft that has been injected into cavity <NUM> will migrate through opening <NUM> and/or opening <NUM> such that some bone graft will exit cavity <NUM> through opening <NUM> and/or opening <NUM> to promote fusion of vertebrae V. In some embodiments, the bone graft comprises cortical demineralized bone fibers, demineralized bone particles (≥ <NUM> ≥ <NUM> in diameter), mineralized cortical/cancellous chips, or a combination thereof. In some embodiments, the bone graft is hydrated with either saline, blood, bone marrow, etc. to provide a flowable mixture that can be delivered via injection into the cavity during pre- and/or post-implantation.

Tip <NUM> of syringe <NUM> is inserted into one of openings <NUM>, 162a, as shown in <FIG>, and bone graft, such as, for example, autograft and/or allograft is injected through one of openings <NUM>, 162a and into passageway <NUM> using syringe <NUM> to at least partially fill passageway <NUM>. In some embodiments, bone graft is injected through one of openings <NUM>, 162a and into passageway <NUM> using syringe <NUM> to completely fill passageway <NUM>. In some embodiments, bone graft that has been injected into passageway <NUM> will migrate through opening <NUM> such that some bone graft will exit passageway <NUM> through opening <NUM> to promote fusion of vertebrae V. In some embodiments, bone graft that has been injected into passageway <NUM> will migrate through opening <NUM> such that some bone graft will exit passageway <NUM> through opening <NUM> and flow into cavity <NUM>.

In some embodiments, bone graft is injected through opening <NUM> and into cavity <NUM> and through one of openings <NUM>, 162a and into passageway <NUM> until implant <NUM> is completely filled with bone graft. In some embodiments, bone graft is injected through opening <NUM> and into cavity <NUM> before bone graft is injected through one of openings <NUM>, 162a and into passageway. In some embodiments, bone graft is injected through opening <NUM> and into cavity <NUM> after bone graft is injected through one of openings <NUM>, 162a and into passageway. In some embodiments, bone graft is injected through opening <NUM> and into cavity <NUM> at the same time that bone graft is injected through one of openings <NUM>, 162a and into passageway.

In some embodiments, all or a portion of at least one of slots <NUM>, holes <NUM>, or hole <NUM> extend transverse to axis A1, such as, for example, an acute angle relative to axis A1 to intentionally direct graft in a desired direction, or intentionally cause the graft to flow away from some area. For example, in some embodiments, all or a portion of at least one of slots <NUM>, holes <NUM>, or hole <NUM> can be angled toward end <NUM> and/or end <NUM> to direct graft towards the endplates of the adjacent vertebral bodies to ensure graft abuts those surfaces. The directionality of the holes could also direct graft into small spaces first that wouldn't necessarily get filled such that those small spaces get filled without restricting graft from filling the larger spaces after the small spaces have been filled. In some embodiments, at least one of cavities <NUM>, <NUM> includes internal baffles to intentionally direct graft within the implant toward a selected portion of a patient's anatomy, for example.

In some embodiments, column <NUM>, body <NUM>, or the entire implant <NUM> is positioned in a bag to allow pressurization of graft to maximize filling of the voids. In some embodiments, the bag comprises a mesh. In some embodiments, the bag is integrally formed with implant <NUM>. In some embodiments, the bag is assembled with implant <NUM> by surgical staff. It is envisioned that this will allow the surgeons a choice to have a tight, close or loose bag, for example. In some embodiments, the bag is assembled with implant <NUM> in situ. In some embodiments, the bag is continuous along the circumference, of implant <NUM> without covering openings <NUM>, <NUM> in order to force graft to be pressed against the endplates of the surrounding vertebral bodies. In some embodiments, the bag is configured to prevent graft loss out any of the external openings of any of the components, ensuring only implant <NUM> is filled with graft to avoid graft from migrating into the space surrounding implant <NUM>. As with many graft materials, they are mixed with a carrier (glycerol, water, etc). Accordingly, in some embodiments, the bag is permeable for the carrier to allow graft to flow into the voids aided by the carrier, but then when compacted the carrier would leach out, maximizing the graft that remains. That is, instead of the carrier remaining between fibers or particles of graft, the graft could be packed tightly against itself. In some embodiments, the bag is non-biodegradable and/or non-resorbable for fusion procedures of extended durations or provide strength to the bag. In some embodiments, the bag is biodegradable and/or resorbable to avoid the bag from getting in the way of bone growth and/or release one or more biologics and/or active pharmaceutical ingredients as the bag degrades/resorbs. In some embodiments, the bag is hydrophilic such that if the graft material requires a certain amount of hydration, possibly to keep adjacent fibers far enough apart to allow bone to integrate, it would be fully hydrated. In some embodiments, mesh or impermeable membranes are placed over one or more of the openings of implant <NUM>, or fill one or more of the openings of implant <NUM> to prevent unwanted migration of the graft outside of implant <NUM>.

In some embodiments, the syringe fills implant <NUM> with graft using the same access point as the inserter and deployment device. In some embodiments, implant <NUM> could be filled with graft from a different surgical access point. For example, in some embodiments, the inserter and driver could require a certain amount of removed material for their access, such that adding any additional perforations may make implant <NUM> too weak. By adding graft injection ports in a different orientation than the inserter access point, both a large window for grafting through is achieved, while providing adequate strength to implant <NUM> for bearing surgical loads. In some embodiments, the syringe delivers a desired amount of graft into implant <NUM> and then the graft could be packed into and/or onto implant <NUM> with another instrument to ensure implant <NUM> is fully filled.

Claim 1:
A spinal implant comprising:
a first member (<NUM>) comprising a first wall (<NUM>) defining an axial passageway (<NUM>) and a first opening (<NUM>), the first opening (<NUM>) being in communication with the axial passageway (<NUM>),
a second member (<NUM>) including a second wall (<NUM>) defining an axial cavity (<NUM>) having the first member (<NUM>) disposed therein, the second wall (<NUM>) defining a second opening (<NUM>) in communication with the axial cavity (<NUM>),
wherein the spinal implant is configured so that bone graft is injectable through the first opening (<NUM>) and into the axial passageway (<NUM>) and through the second opening (<NUM>) and into the axial cavity (<NUM>) after the spinal implant is implanted within the patient,
characterized in that
the spinal implant is further configured so that a tip (<NUM>) of a delivery instrument is positionable into the first opening (<NUM>) and bone graft is injectable through the first opening (<NUM>) and into the axial passageway (<NUM>) and the tip (<NUM>) of the delivery instrument is positionable in the second opening (<NUM>) and bone graft is injectable through the second opening (<NUM>) and into the axial cavity (<NUM>).