Implants, systems and methods for installing implants

Abstract

A system include, for example, an implant having a plurality of passageways, a plurality of screws, each having a threaded portion and which is receivable in a different one of the plurality passageways in the implant, and an inserter. The inserter is operable for simultaneously rotating the plurality of screws from a first position relative to the implant in which the implant is positionable in an installation site, and a second position relative to the implant with distal ends of the plurality of screws extending from the implant for securing the implant in the installation site. In some embodiments, the inserter may include a gear box in which a drive pinion engages a plurality of gears, which elongated gears are operably to rotate and linearly move the plurality of screws.

Description

IMPLANTS, SYSTEMS AND METHODS FOR INSTALLING IMPLANTSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application perfects and claims the priority benefit of U.S. Provisional Patent Application No. 63 / 590,916, filed October 17, 2023, entitled "Implants, Systems And Methods For Installing Implants," which application is hereby incorporated herein by reference in its entirety.FIELD OF THE DISCLOSURE

[0002] The present disclosure relates generally to orthopedic surgery, and more particularly to implants, systems and methods for installing implants.BACKGROUND

[0003] Implants are used in orthopedics for the fixation of bones. For example, interbody implants are often employed for patients having spinal stenosis and requiring decompression and fusion. The interbody implants are placed between the vertebrae in the patient's spine. The interbody implant is typically secured in place with screws.

[0004] U.S. Patent No. 10,238,504 issued to Mesiwala discloses an intervertebral spinal implant assembly sized and dimensioned for the lumbar or cervical spine implantable via an anterior approach, which includes an implant, bone fasteners, and instruments for delivering the implant and bone fasteners such as bone spikes and bone nails.SUMMARY

[0005] Shortcomings of the prior art are overcome and additional advantages are provided through the provision, in one embodiment, of a system, which includes, for example, an implant having a plurality of passageways, a plurality of screws, each having a threaded portion receivable in a different one of the plurality passageways in the implant, and an inserter. The inserter is operable for simultaneously rotating the plurality of screws from a first position relative to the implant in which distal portions of the plurality of screws are disposed in the implant to a second position relative to theimplant in which the distal portions of the plurality of screws extend from the implant. The embodiments may include implant inserted anteriorly, laterally, posteriorly and obliquely relative to the spine.

[0006] In some embodiments, the inserter may include a gear box having a gear case and plurality of gears, each of which is operably engageable with a different one of the plurality of screws. The inserter may include the gear box having a gear case with a plurality of chambers for use in supporting the plurality of gears, the plurality of chambers defining a plurality of axes, and the gear case having a plurality of passageways for receiving the plurality of screws, the passageways defining a plurality of axes parallel to the plurality of axes of the plurality of chambers. The inserter may include a single drive pinion and the plurality of gears may be operably engageable with the single drive pinion. The single drive pinion may include helical teeth and the plurality of gears may include an elongated rotatable body having a plurality of elongated helical teeth operable for rotating and linearly moving the plurality of screws.

[0007] In another embodiment, a method includes, for example, providing the above system, inserting the implant with the plurality of screws into an installation site of a patient, simultaneously rotating the plurality of screws into the installation site, and disconnecting the inserter from the implant.

[0008] In another embodiment, an inserter is operably attachable to an implant having a plurality of screws. The inserter includes a housing, at least one rotatable member disposed in the housing, the at least one rotatable member having a first end and a second end, at least one pinion attached to the first end of the at least one rotatable member, the at least one pinion operably engageable with the plurality of screws, and wherein the inserter is operable to simultaneously rotate the plurality of screws from a first position relative to the implant in which distal portions of the plurality of screws are disposed in the implant to a second position relative to the implant with the distal portions of the plurality of screws extending from the implant.

[0009] In another embodiment, a method includes, for example, providing an inserter connected to an implant having a plurality of screws disposed in a plurality passageways in the implant, inserting the implant with the plurality of screws into aninstallation site of a patient, simultaneously rotating the plurality of screws into the installation site in the patient, and disconnecting the inserter from the implant. The simultaneously rotating may include rotating a pinion having teeth engageable with at least one of the plurality of screws, or a single member with teeth engageable with and rotating the plurality of screws. The simultaneous rotating may include using the inserter to manually and simultaneously rotate the screws into the installation site, or using the inserter to automatically simultaneously rotate the screws into the installation site.

[0010] In another embodiment, a method includes, for example, providing an inserter having a gear box connected to an implant and a plurality of screws disposed in a plurality of passageways in the gear box, operating the inserter to simultaneously rotate the plurality of screws from a first position relative to the implant in which distal portions of the plurality of screws are disposed in the implant are disposed in the implant to a second position relative to the implant with the distal portions of the plurality of screws extending from the implant, and disconnecting the inserter from the implant.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The subject matter which is regarded as the disclosure is particularly pointed out and distinctly claimed in the concluding portion of the specification. The disclosure, however, may best be understood by reference to the following detailed description of various embodiments and the accompanying drawings in which:

[0012] FIG. 1 is a perspective view of an implant system having an implant, a plurality of screws, and an inserter, according to an embodiment of the present disclosure;

[0013] FIG. 2 is an enlarged perspective view of the implant of FIG. 1 , according to an embodiment of the present disclosure;

[0014] FIGS. 3-8 are front, right, left, top, bottom, and rear side views of the implant of FIG. 2, according to an embodiment of the present disclosure;

[0015] FIGS. 9 and 10 are perspective views of the implant of FIG. 2, according to an embodiment of the present disclosure;

[0016] FIG. 1 1 is an enlarged perspective view of one of the plurality of screws of FIG. 2, according to an embodiment of the present disclosure;

[0017] FIG. 12 is an enlarged perspective view of the implant and the plurality of screws of FIG. 2, according to an embodiment of the present disclosure;

[0018] FIG. 13 is a perspective view of the inserter of FIG. 1 , according to an embodiment of the present disclosure;

[0019] FIG. 14 is a perspective view, portions removed and cutaway, of the inserter of FIG. 13, according to an embodiment of the present disclosure;

[0020] FIG. 15 is an end view of the gear mechanism of the inserter of FIG. 14, according to an embodiment of the present disclosure;

[0021] FIG. 16 is a perspective view of the gear mechanism of the inserter of FIG. 14, according to an embodiment of the present disclosure;

[0022] FIG. 17 is a perspective view of the pinion of the inserter of FIG. 14, according to an embodiment of the present disclosure;

[0023] FIGS. 18-21 diagrammatically illustrate a process for installing the implant in a patient using the inserter of FIG. 13, according to an embodiment of the present disclosure;

[0024] FIG. 22 is a perspective view of an implant system having an implant, a plurality of screws, and an inserter, according to an embodiment of the present disclosure;

[0025] FIG. 23 is an enlarged perspective view of the implant of FIG. 22, according to an embodiment of the present disclosure;

[0026] FIGS. 24 and 25 are enlarged perspective views of one of the plurality of screws of FIG. 22, according to an embodiment of the present disclosure;

[0027] FIG. 26 is a perspective view of the implant and the plurality of bone screws of FIG. 22, according to an embodiment of the present disclosure;

[0028] FIG. 27 is a perspective view of the inserter of FIG. 22, according to an embodiment of the present disclosure;

[0029] FIG. 28 is a perspective view, portions removed, of the inserter of FIG. 22, according to an embodiment of the present disclosure;

[0030] FIG. 29 is a perspective view of the gear mechanism of the inserter of FIG. 28, according to an embodiment of the present disclosure;

[0031] FIG. 30 is a perspective view of one of the pinions of the inserter and one of the screws of FIG. 22, according to an embodiment of the present disclosure;

[0032] FIG. 31 is a perspective view of an implant system having an implant, a plurality of screws, and an inserter, according to an embodiment of the present disclosure;

[0033] FIG. 32 is an enlarged perspective view of the implant of FIG. 31 , according to an embodiment of the present disclosure;

[0034] FIG. 33 is an enlarged perspective view of the implant of FIG. 31 , according to an embodiment of the present disclosure;

[0035] FIG. 34 is a perspective view of one of the rotatable inserts of the implant of FIG. 33, according to an embodiment of the present disclosure;

[0036] FIG. 35 is a cross-sectional view of the rotatable insert of FIG. 34, according to an embodiment of the present disclosure;

[0037] FIG. 36 is an enlarged perspective view of one of the plurality of screws of FIG. 31 , according to an embodiment of the present disclosure;

[0038] FIG. 37 is a perspective view of the inserter of FIG. 31 , according to an embodiment of the present disclosure;

[0039] FIG. 38 is an enlarged perspective view of the pinion of the inserter of FIG. 37, according to an embodiment of the present disclosure;

[0040] FIG. 39 is an enlarged top view of the implant, the plurality of screws, and distal portion of the inserter of FIG. 31 with the plurality of screws disposed in a first or initial position, according to an embodiment of the present disclosure;

[0041] FIG. 40 is an enlarged top view of the implant, the plurality of screws, and distal portion of the inserter of FIG. 39 with the plurality of screws disposed in a second or installed position, according to an embodiment of the present disclosure;

[0042] FIGS. 41 and 42 are perspective views of an inserter having a motor and a battery, according to an embodiment of the present disclosure;

[0043] FIG. 43 is a flowchart of a method for installing an implant in an installation site, according to an embodiment of the present disclosure;

[0044] FIG. 44 is a perspective view of an implant system having an implant, a plurality of screws, and an inserter having a gear box, according to an embodiment of the present disclosure;

[0045] FIG. 45 is an enlarged perspective view of the implant of FIG. 44, according to an embodiment of the present disclosure;

[0046] FIGS. 46-51 are front, right, left, top, bottom, and rear side views of the implant of FIG. 45, according to an embodiment of the present disclosure;

[0047] FIGS. 52 and 53 are a top perspective view and bottom perspective view of the implant of FIG. 45, according to an embodiment of the present disclosure;

[0048] FIGS. 54 and 55 are enlarged perspective views of one of the plurality of screws of FIG. 44, according to an embodiment of the present disclosure;

[0049] FIG. 56 is an exploded perspective view of the inserter of FIG. 44, according to an embodiment of the present disclosure;

[0050] FIG. 57 is an enlarged, exploded, partial perspective view of the elongated housing assembly, the rotatable drive pinion assembly, and the rotatable attachment assembly of the inserter of FIG. 56, according to an embodiment of the present disclosure;

[0051] FIGS. 58 and 59 are enlarged perspective views of the gear box and distal portion of the elongated housing assembly of the implant system of FIG. 44, according to an embodiment of the present disclosure;

[0052] FIGS. 60-63 are perspective views of the gear case of the gear box of FIGS. 58 and 59, according to an embodiment of the present disclosure;

[0053] FIG. 64 is an enlarged perspective view of one of the gears of the gear box of FIG. 56, according to an embodiment of the present disclosure;

[0054] FIG. 65 is an enlarged side view of the distal ends of the elongated housing assembly, rotatable drive pinion assembly, and rotatable attachment assembly of FIG. 56, according to an embodiment of the present disclosure;

[0055] FIG. 66 is a side view of the distal ends of the elongated housing assembly, rotatable drive pinion assembly, and rotatable attachment assembly of FIG. 65, and gears of the gear box, according to an embodiment of the present disclosure;

[0056] FIG. 67 is a side view of the distal ends of the elongated housing assembly, rotatable drive pinion assembly, and rotatable attachment assembly of FIG. 65, and gears of the gear box and the screws, according to an embodiment of the present disclosure;

[0057] FIGS. 68-73 diagrammatically illustrate a process for installing the implant in a patient using the inserter of FIG. 44, according to an embodiment of the present disclosure; and

[0058] FIG. 74 is a flowchart of a method for installing an implant in an installation site, according to an embodiment of the present disclosure.DETAILED DESCRIPTION

[0059] Generally, the present disclosure is directed to implants, systems and methods for installing implants. For example, the implants may be interbody implants placed between the vertebrae in a patient's spine and secured in place with screws. For example, an implant system may include an interbody implant, a plurality of screws, and an implant driver / inserter for simultaneously rotating and installing the screws throughthe implant and into the vertebrae. It will be appreciated that the present disclosure may be employed in different regions of the spine using different surgical approaches and / or with the installation of other types of implants. In other embodiments, the driver / inserter may be motorized allowing for automatically simultaneously rotating and installing the screws.

[0060] In this detailed description and the following claims, the words proximal, distal, anterior, posterior, medial, lateral, superior, and inferior are defined by their standard usage for indicating a particular part of a bone, instrument or implant according to the relative disposition of the natural bone or directional terms of reference.

[0061] Positions or directions may be used herein with reference to anatomical structures or surfaces. For example, as the current implants, systems and methods are described herein with reference to use with the bones of the spine, and the bones of the spine may be used to describe the surfaces, positions, directions or orientations of the implants, systems and methods. Further, the devices and surgical methods, and the aspects, components, features and the like thereof, disclosed herein may be described with respect to one side of the body for brevity purposes. However, as the human body is relatively symmetrical or mirrored about a line of symmetry (midline), it is hereby expressly contemplated that the device and surgical methods, and the aspects, components, features and the like thereof, described and / or illustrated herein may be changed, varied, modified, reconfigured or otherwise altered for use or association with another side of the body for a same or similar purpose without departing from the spirit and scope of the disclosure.

[0062] In some embodiments, the present disclosure is directed to implants and preloaded implant inserters with a manual or an automatic drive system for simultaneously installing the screws for securing in place the implant. For example, the implant may be a spinal interbody (ACDF, ALIF, Direct Lateral or oblique) device that is preloaded onto an inserter with the screws already positioned and poised to be screwed into the vertebra. Once the implant is placed into the disc space of the patient, the surgeon simply manually turns or activates an actuator of the driver / inserter to simultaneously drive two, three, four or more screws such as self-drilling, self-tappingscrews at the same time to secure the implant. With the screws in place, the driver / inserter is operably detached from the implant and the procedure completed.

[0063] For example, an implant device / system may be assembled by a surgeon, assistant or scrub tech on a back table. Bone graft, or any appropriate osteoconductive, osteoinductive or osteogenic material of the surgeon’s selection may also be loaded into one or more open chambers of the implant at this time. The implant device / system with the screws loaded is positioned on the inserter and the entire implant assembly is then positioned in the interbody space. Once positioned, the surgeon deploys the screws directly into the bone, for example, without any extra steps. With the implant device / system secured between the vertebra, the inserter is detached from the implant, and the procedure is completed. This integrated inserter / driver may provide benefits during installation, e.g., by providing simultaneous installation of a plurality of screws in the implantation site.

[0064] FIG. 1 illustrates a system 10 generally having an implant 100 such as an interbody implant, a plurality of bone screws 200, and an inserter 300, according to the embodiment of the present disclosure. As described below, the implant 100 and the plurality of bone screws 200 may be assembled and positionable between at least two bones such as two vertebral bodies, and the plurality of screws 200 simultaneously installed using the inserter 300. In this embodiment, the inserter 300 includes a rotatable member having teeth such as a single pinion for simultaneously rotating and driving the plurality of screws 200.

[0065] As shown in FIG. 2, the implant 100 may include a body 110 having a first passageway 1 12 defining an axis A1 and a second passageway 1 14 defining a second axis B1 extending therethrough for receiving the plurality of screws 200 (FIG. 1 ). Implant 100 can also include a bone graft chamber 101 to facilitate interbody fusion and a series of ridges or teeth 103 on a top side 126, and a series of teeth 105 on a bottom side 128 to minimize displacement once inserted and enhance overall stability of the fusion construct. With reference to FIGS. 3-8, implant 100 includes a front or anterior side 129, lateral sides 122 and 124, the top side 126, the bottom side 128, and a rear orposterior side 120. Implant 100 may taper in thickness from the front or anterior side to the rear or posterior side.

[0066] As shown in FIGS. 9 and 10, a first recessed portion 1 13 of interbody 100 may extend across portions of the anterior side 129, the top side 126, and the lateral side 122. The passageway 112 in interbody 100 may open onto bottom side 128 at one end and the recessed portion 1 13 at the other end. A second recessed portion 1 15 of interbody 100 may extend across portions of the anterior side 129, the bottom side 128, and the lateral side 124. The passageway 1 14 may open onto top side 126 at one end and the recessed portion 115 at the other end. With reference again to FIG. 4, when viewed from the side, the passageways 1 12 and 114 may be disposed at about 90 degrees from each other.

[0067] FIG. 1 1 illustrates one of the plurality of bone screws 200, according to an embodiment of the present disclosure. For example, the bone screw 200 may include a body 210 having a threaded shank portion 220, a non-threaded shank portion 230, and a head portion 240. Head portion 240 may include a geared crown. The plurality of screws 200 are receivable in the passageways in implant 100 as shown in FIG. 12.

[0068] With reference to FIG. 13 , the inserter 300 may generally include an elongated housing 310 and a rotatable handle 320, according to an embodiment of the present disclosure. As shown in FIG. 14, inserter 300 may also include inner shaft 330, a rotatable outer shaft 340, gear mechanism 350 such as a manually operated gear mechanism, and a pinion 360, according to an embodiment of the present disclosure. For example, the inserter 300 may provide an external pinion drive for engaging and simultaneously rotating and installing the plurality of screws as described below.

[0069] Inserter 300 may include an end cap 312. The end cap 312 may be attached to a proximal end 332 of the inner shaft 330. The inner shaft may extend through gear mechanism 350 and pinion 360. A distal end 334 of the inner shaft 330 may include a connector 336 for removably attaching the inner shaft 330 to the implant such as a threaded end for releasably attaching connector 223 to the implant 100 (FIG. 1 ). In other embodiments, the distal end of inner shaft may be provided with other types of releasable connectors for attaching the inserter to the implant. Suitable releasablyconnectors may include a releaseable snap fit connector, releasably detent connector, or other suitable releasable connectors.

[0070] As shown in FIGS. 15 and 16, in one embodiment, gear mechanism 350 may include a plurality of planetary-type gears for rotating a proximal end 342 of the outer shaft 340. A distal end 344 (FIG. 14) of outer shaft 340 is fixedly attached to pinion 360 (FIG. 14). With reference again to FIGS. 13 and 14, for example, an inner surface (not shown) of rotatable handle 320 (FIG. 13) may be fixedly attached to an outer surface 354 (FIG. 14) of a hollow cylindrical gear 352. The hollow cylindrical gear 352 includes internal teeth and is operable via a plurality of smaller gears to transfer rotation of the handle into rotation of outer shaft 340. For example, a surgeon may grasp housing 310 with one hand, grasp handle 320 with the other hand, and while maintaining the housing 310 stationary, rotate the handle 320 clockwise in the direction of curved arrow R1 (FIG. 13), which in turn causes outer shaft 340 (FIG. 14) and pinion 360 (FIG. 13) to rotate counter-clockwise in the direction of curved arrow R2 (FIG. 13). The handle may be a ratcheting or non-ratcheting handle.

[0071] With reference to FIG. 17, the pinion 360 may be a bevel gear having helical or spiral teeth 362 on a conical shaped geometry that meshes with the helical or spiral teeth of the plurality of screws. The pinion 360 may include a proximal portion 364 having teeth 362 and a distal portion 366 void of teeth. The distal portion 366 is operable to disengage from the implant once the screws are installed. The pinion 360 is operable to simultaneously drive the plurality of screws at an angle. It will be appreciated that other gear types and configurations may be employed for engaging the geared crown of the bone screws, such as straight bevel gears and miter gears.

[0072] FIGS. 18-21 illustrate a process for installing the implant 100, for example, in a patient’s lumbar spine, according to the embodiment of the present disclosure. For example, initially an implantation site 20 in the spine 50 in the patient is prepared for receiving the implant as shown in FIG. 18. In other embodiments, an implantation site may be sized and configured in connection with the thoracic and cervical spine.

[0073] The inserter 300, implant 100, and plurality of screws 200 are preassembled. For example, the plurality of screws 200 are operably inserted into the implant 100, andthe implant 100 is operably attached to the inserter 300 prior to introducing the assembled structure into the implantation site in the patient.

[0074] The assembled implant, screws, and inserter is aligned with the implant location and moved in the direction of arrow X so that implant 100 is received in the implantation site 20 as shown in FIG. 19. In the case of FIGS. 18-21 , the implantation site is an intervertebral disc space. In other embodiments, other implant locations in a patient’s body and implants employing the technique of the present disclosure may be prepared for such implant, for example, in the fusion of articular joints or osteotomy sites in the hand, feet, limbs and pelvis.

[0075] The handle 320 (FIG. 13) of inserter 300 is rotated relative to housing 310 (FIG. 13) by the surgeon, for example, handle 320 (FIG. 13) is rotated clockwise in the direction of curved arrow R1 (FIG. 13) while holding housing 310 (FIG. 13) from rotation, which causes the pinion 360 to rotate counterclockwise in the direction of arrow R2 around the axis of the pinion 360, thereby causing the first screw 200 to rotate clockwise in the direction of R3 around the axis of first screw 200 and the second screw 200 to rotate clockwise in the direction R4 around the axis of the second screw 200 to simultaneously install the plurality of screws 200 as shown in FIG. 20. Thereafter, the inserter 300 is disconnected from the implant 100 leaving the implant 100 and screws 200 installed in the patient as shown in FIG. 21 .

[0076] FIG. 22 illustrates a system 1010 generally having an implant 1100, plurality of bone screws 1200, and an inserter 1300, according to the embodiment of the present disclosure. As described below, the implant 1100 and the plurality of bone screws 1200 may be assembled and positionable between at least two bones such as two vertebral bodies, and the plurality of screws 1200 simultaneously installed using the inserter 1300. In this embodiment, the inserter 1300 includes a plurality of pinions for simultaneously rotating and driving the plurality of screws 1200.

[0077] As shown in FIG. 23, the implant or interbodyl 100 may include a body 1 1 10 having a first passageway 1 1 12 defining an axis A2 and a second passageway 1 1 14 defining a second axis B2 extending therethrough for receiving the plurality of screws1200 (FIG. 26). The implant 1100 may be essentially the same as implant or interbody 100 (FIG. 2).

[0078] FIGS. 24 and 25 illustrate one of the plurality of bone screws 1200, according to an embodiment of the present disclosure. For example, the bone screw 1200 may include a body 1210 having a threaded shank portion 1220, a non-threaded shank portion 1230, and a head portion 1240. The head portion 1240 may include a drive socket 1250. The plurality of bone screws 1200 are receivable in the passageways 1212 and 1214 in implant 1100 as shown in FIG. 26.

[0079] With reference to FIGS. 27 and 28, the inserter 1300 may generally include an elongated housing 1310 (FIG. 27) and a rotatable handle 1320, according to an embodiment of the present disclosure. As shown in FIG. 28, inserter 300 may also include a plurality of shafts 1370 and 1380, and a gear mechanism 1340 according to an embodiment the present disclosure. Distal ends 1374 and 1384 of the plurality of shafts 1370 and 1380 (FIG. 28) may include pinions 1376 and 1378, respectively. For example, the inserter 1300 may provide a plurality of internal pinion drives for engaging and simultaneously rotating and installing the plurality of screws as described below. As shown in FIG. 27, a distal portion of the housing 1310 may include separate chambers containing the shafts.

[0080] As shown in FIG. 29, gear mechanism 1340 may include an outer rotatable hollow cylindrical gear 1342 for driving a plurality of gears 1344 and 1346 operably attached to and for operably rotating proximal ends 1372 and 1382 of first shaft 1370 and second shaft 1380, respectfully. With reference again to FIGS. 27 and 28, for example, an inner surface (not shown) of rotatable handle 1320 may be fixedly attached to an outer surface 1345 (FIG. 28) of the rotatable hollow cylindrical gear 1342. The hollow cylindrical gear 1342 with internal teeth is operable via the plurality of smaller gears to transfer rotation of the handle into rotation of the first shaft 1370 and the second shaft 1380. For example, a surgeon may grasp housing 1310 with one hand, grasp handle 1320 with the other hand, and while maintain housing 1310 stationary, rotate handle 1320 clockwise, which in turn causes the first outer shaft 1370 and firstpinion 1376 to rotate clockwise, and the second outer shaft 1380 and second pinion 1386 to rotate clockwise. The handle may be a ratcheting or non-ratcheting handle.

[0081] With reference to FIG. 30, first pinion 1376 may be a bevel gear having helical or spiral teeth 1377 on a semi-spherical geometry that meshes with the helical or spiral teeth of the plurality of screws. The pinion 1376 and the pinion 1385 (FIG. 28) are operable to simultaneously drive the plurality of screws at an angle. It will be appreciated that other gear configurations may be employed for engaging the drive socket of the bone screws such as straight bevel gears and miter gears.

[0082] The process of installing the implant 1100 in a patient is similar to the process for installing the implant 100 (FIGS. 18-21 ).

[0083] With reference again to FIG. 22, initially an implantation site in a patient's spine is prepared in the patient for receiving the implant. The inserter 1300, the implant 1 100, and the plurality of screws 1200 are preassembled. For example, the plurality of screws 1200 are operably inserted into the implant 1 100, and the implant 1100 is operably attached to the inserter 1300 via a threaded connector 1301 . The assembled implant, screws, and inserter is aligned with the implant location and moved so that the implant 1 100 is received in the implantation site. The inserter 1300 is manually operated by the surgeon, which causes the two pinions 1376 and 1386 to rotate, thereby causing first screw 1200 to rotate and second screw 1200 to rotate to install the plurality of screws in the patient's bones. Thereafter, the inserter 1300 is operably disconnected from the implant 1100 leaving the implant 1 100 and screws 1200 installed in the patient.

[0084] FIG. 31 illustrates a system 2010 generally having an implant 2100, plurality of bone screws 2200, and an inserter 2300, according to the embodiment of the present disclosure. As described below, implant 2100 and the plurality of bone screws 2200 may be assembled and positionable between at least two bones such as two vertebral bodies, and the plurality of screws 2200 manually installed using the inserter 2300. In this embodiment, the implant 2300 includes a plurality of rotatable inserts and inserter 2300 includes a single pinion for rotating the plurality of rotatable inserts which in turnrotate and simultaneously drive and install the plurality of screws 2200 as described below.

[0085] As shown in FIGS. 32 and 33, the implant 2100 includes a body 21 10 having a first passageway 2112 defining an axis A3 and a second passageway 2114 defining a second axis B3 extending therethrough for receiving the plurality of screws 2200 (FIG. 31 ). The implant 2100 may include a bone graft chamber and teeth as described above. The implant 2100 may be essentially the same as implant 100 (FIG. 2) with the exception of having a plurality of rotatable inserts 2150 (one of which is shown in FIG. 33) operable for use in simultaneously rotating and driving the plurality of screws 2200 (FIG. 31 ) as described below.

[0086] As shown in FIG. 34 and 35, the insert 2150 includes a body 2152 having a first cylindrical end portion 2154 and a bevel gear portion 2156. The insert 2150 includes a passageway 2160 extending therethrough. The passageway 2160 includes a groove 2162. The passageway 2160 and the groove 2162 are sized and configured for receiving the bone screw 2200 (FIG. 36) therein.

[0087] FIG. 36 illustrates one of the plurality of bone screws 2200, according to an embodiment of the present disclosure. For example, the bone screw 2200 may include a body 2210 having a threaded shank 2220, and a head portion 2240. The plurality of screws 2200 are receivable in the inserts in the passageways 2112 and 2114 (FIG. 32) in implant 2100 (FIG. 32).

[0088] With reference to FIGS. 37 and 38, the inserter 2300 may generally include an elongated housing 2310, a rotatable shaft 2320 attached to a pinion 2360, and a manually driven gear mechanism (not shown in FIG. 37 and 38), according to an embodiment of the present disclosure. For example, the inserter 2300 may provide an external pinion drive for engaging the rotatable inserts to simultaneously rotate and drive and install the plurality of screws as described below.

[0089] Pinion 2360 may be a bevel gear having teeth on a conical shaped geometry that meshes with the teeth of the rotatable inserts 2150 (FIGS. 34 and 35). The pinion 2360 is operable to simultaneously rotate the rotatable inserts, which in turn rotate anddrive the plurality of screws. It will be appreciated that other gear configurations may be employed for engaging the rotatable inserts, such as straight bevel gears and miter gears.

[0090] FIGS. 39 and 40 illustrate a process for installing the implant 2100 in a patient, according to the embodiment of the present disclosure. For example, initially an implantation site in the spine in the patient is prepared for receiving the implant.

[0091] The inserter 2300, implant 2100, and plurality of screws 2200 are preassembled. For example, the plurality of screws 2200 are operably threadedly inserted into the rotatable inserts 2150 in implant 2100, and the implant 2100 is operably attached to the inserter 2300. For example, pinion 2360 is received in the implant 2100 with the pinion engageable with the bevel gears of the rotatable insert 2150. The assembled implant, screws, and inserter is aligned with the implant location and the implant 2100 is moved into and received in the implantation site.

[0092] The inserter 2300 is activated by the surgeon by operably manually operating the ratcheting or non-ratcheting handle 2320, which causes the pinion 2360 to rotate around the axis of the pinion with the plurality of screws 2200 disposed in a first position shown in FIG. 39, thereby simultaneously causing the first rotatable insert 2150 to rotate thereby rotating the first screw 2200, and causing the second rotatable insert 2150 to rotate thereby rotating the second screw 2200 until the screws 2200 are disposed in a second installed position as shown in FIG. 40. Thereafter, the inserter 2300 is removed and / or disconnected from the implant 2100 leaving the implant 2100 and screws 2200 installed in the patient. In some embodiments, the surgeon may tighten the plurality of screws, e.g., using a manual driver such as a TORX or star screw driver, to seat the screws in a final position relative to the implant.

[0093] FIG. 41 illustrates a system 3010 generally having an implant 3100, plurality of bone screws 3200, and a motorized inserter 3300, according to the embodiment of the present disclosure. The inserter 3300 may be essentially the same as inserter 300 (FIG. 1 ) with the exception of being, for example, a battery operated motorized driver to automatically and simultaneously install a plurality of screws. For example, as shown in FIG. 42, motorized inserter 3300 (FIG. 41 ) may include a motor 3390, a battery 3392,and an activation or on / off button or switch 3395 (FIG. 41 ). The inserter 3300 may provide an external pinion drive for engaging the rotatable inserts and automatically simultaneously driving and installing the plurality of screws as described below. From the present disclosure, it will be appreciated that inserters 300, 1300, and 2300 may be motorized having a motor, a battery, and an on / off button or switch. The battery may be a rechargeable battery or disposable battery. The motor may be a DC electric motor capable of converting the electrical energy of the battery to kinetic energy capable of driving a rotating shaft configured to rotate the gears at variable speeds and appropriate torques.

[0094] In other embodiments, the present description is directed to an interbody fusion device designed to be positioned between two vertebrae in the lumbar, thoracic or cervical spine to be fused using a plurality of bone screws and an inserter. The inserters are designed to be releasably attachable to the interbody device and drive the plurality of bone screws via a drive mechanism. The interbody fusion device is designed to be attached to the vertebrae with the plurality of bone screws. The inserter releaseably attachable to the interbody fusion device forming an assembly prior to positioning the interbody fusion device between the two vertebrae to be fused. The assembly is loaded with a plurality of bone screws for fixation of the interbody fusion device to the vertebrae. Once the assembly is positioned between vertebrae and the bone screws loaded into the assembly, the inserter drive mechanism can be actuated either manually or automatically to drive the bone screws into the vertebrae. The interbody fusion device, the plurality of bone screws, and the inserter may be preassembled for placement into the space between the vertebrae as a single unit. Once the preassembled single unit is placed between vertebrae, the plurality of bone screws are screwed into the vertebrae in a substantially simultaneous manner by actuating the inserter drive mechanism.

[0095] The technique of the present disclosure may provide bone fusion systems positioned between two bones (a joint) or two bone portions (an osteotomy).

[0096] FIG. 43 illustrates a method 4000 for installing an implant in an installation site, according to an embodiment of the present disclosure. Exemplary method 4000may include at 4100 inserting a plurality of screws in a plurality passageways in an implant, at 4200 connecting an inserter to the implant with the plurality of screws, at 4300 inserting the implant with the plurality of screws in an installations site, at 4400 simultaneously rotating the of plurality screws into the installation site, and at 4500 disconnecting the inserter from the implant.

[0097] FIG. 44 illustrates a system 5010 generally having an implant 5100 such as an interbody implant, a plurality of bone screws 5200, and an inserter 5300, according to the embodiment of the present disclosure. In this exemplary embodiment, system 5010 provides a single main pinion, which single main pinion rotates and meshes with two drive gears, which two drive gears rotate to rotate the two bone screws for installing the implant into an installation site of a patient. For example, system 5010 may include a gear box that may allow the inserter to be more closely positioned adjacent to the installation site in the patient. As described below, the implant 5100, the plurality of bone screws 5200, and the inserter 5300 may be assembled and positionable between at least two bones such as two vertebral bodies, and the plurality of screws 5200 simultaneously installed by a surgeon using the inserter 5300.

[0098] As shown in FIG. 45, the implant 5100 may be essentially similar to the implant 100 (FIG. 2), according to an embodiment of the present disclosure. For example, the implant 5100 may include a body 5110 having a first passageway 51 12 (FIG. 50) defining an axis A3 and a second passageway 51 14 defining a second axis B3 extending therethrough for receiving the plurality of screws 5200 (FIG. 1 ). Implant 5100 can also include a bone graft chamber 5101 to facilitate interbody fusion and a series of ridges or teeth 5103 on a top side 5126, and a series of teeth 5105 on a bottom side 5128 to minimize displacement once inserted and enhance overall stability of the fusion construct.

[0099] With reference to FIGS. 46-51 , implant 5100 includes a front or anterior side 5129, lateral sides 5122 and 5124, the top side 5126, the bottom side 5128, and a rear or posterior side 5120. The implant 5100 may taper in thickness from the front or anterior side to the rear or posterior side.

[0100] As shown in FIGS. 52 and 53, the implant 5100 may include a threaded opening 5130 opening onto the anterior side 5129 of the implant, which threaded opening is operable for attaching to inserter 5300 (FIG.44).

[0101] A first recessed portion 51 13 of the implant 5100 may extend across portions of the anterior side 5129, the top side 5126, and the lateral side 5122. The passageway 5112 (FIG. 53) in the implant 5100 may open onto the recessed portion 51 13 at one end of the passageway and onto the bottom side 5128 (FIG. 50) at the other end of the passageway. A second recessed portion 5115 (FIG. 53) of the implant 5100 may extend across portions of the anterior side 5129, the bottom side 5128 (FIG. 49), and the lateral side 5124. The passageway 51 14 (FIG. 52) of the implant 5100 may open onto the recessed portion 5115 at one end of the passageway and onto the top side 5126 at the other end of the passageway. When viewed from the side as shown in FIG. 47, the passageways 51 12 and 51 14 may be disposed at about 90 degrees from each other.

[0102] FIGS. 54 and 55 illustrates one of the plurality of bone screws 5200, according to an embodiment of the present disclosure. For example, the bone screw 5200 may include a body 5210 having a threaded shank portion 5220, a non-threaded shank portion 5230, and a head portion 5240. Head portion 5240 may include a geared crown. For example, the head portion 5240 may have a plurality of axially disposed teeth 5242. As described below, the plurality of screws 5200 are receivable in the passageways in the gear box and in the passageways of in the implant.

[0103] With reference to FIG. 56, the inserter 5300 may generally include an elongated housing assembly 5310, a rotatable drive pinion assembly 5360, a rotatable inner attachment assembly 5370, a gear box 5800, and a pair of attachment bolts 5900, according to an embodiment of the present disclosure. As described below, the housing inner shaft assembly 5370 extends through the gear box 5800 and releasably attaches to the implant, and the drive pinion assembly 5360 engages gears in the gear box to drive the bone screws.

[0104] With reference to FIGS. 56 and 57, the elongated housing assembly 5310 includes a hollow shaft 5312 and an end cap 5314. The plurality of attachment bolts5900 attaches the end cap 5314 to the gear box 5800 (FIG. 56). The drive pinion assembly 5360 includes a hollow shaft 5362. Attached to a distal end of the drive pinion assembly 5360 is a drive pinion 5364 having a plurality of teeth 5366, and attached to a proximal end of the drive pinion assembly 5360 is a handle 5366 (FIG. 56). The inner attachment assembly 5370 includes a shaft 5372 having a threaded distal end 5374, which is attachable to the implant, and a handle 5376 (FIG. 56) attached to the proximal end of the shaft 5372.

[0105] For example, during assembly of the inserter 5300, the proximal end of the hollow shaft 5362 of the drive pinion assembly 5360 may be received in the distal end of the hollow shaft 5312 of the elongated housing assembly and attached to handle 5366 (FIG. 53). The proximal end of the shaft 5372 (FIG. 57) of the inner attachment assembly 5370 may be inserted into the distal end of the hollow shaft 5362 of the drive pinion assembly 5360, through handle 5366 (FIG. 56) of the drive pinion assembly 5360, and a proximal end of the shaft 5372 may be attached to handle 5376 (FIG. 56).

[0106] As shown in FIGS. 58 and 59, gear box 5800 may include a gear case 5810 and a plurality of gears 5850 supported on a plurality of pins or axles 5860, according to an embodiment of the present disclosure.

[0107] With reference to FIGS. 60-63, the gear case 5810 may include a mounting plate 5820, a first gear and screw housing portion 5830, and a second gear and screw housing portion 5840. The mounting plate 5820 includes a planar surface 5822 engageable with a planar surface 5316 (FIG. 59) of the end cap 5314 (FIG. 59) of the elongated housing 5310 (FIG. 59). The first gear and screw housing portion 5830 includes a passageway 5832 for receiving one of the screws 5200 (FIG. 54) and a chamber 5834 (FIG. 60) for receiving one of the gear 5850 (FIG. 58) and axle 5860 (FIG. 58). The second gear and screw housing portion 5840 includes a passageway 5842 for receiving one of the screws 5200 (FIG. 54) and a chamber 5844 for receiving one of the gears 5850 (FIG. 58) and axle 5860 (FIG. 58). Gear case 5810 may include a passageway 5812 having a first portion for receiving a distal end or guide boss 5318 (FIGS. 58 and 59) of elongated housing assembly 5310 and a second portions throughwhich threaded end 5374 (FIG. 56) of the rotatable inner shaft assembly 5372 (FIG. 57) extends for attaching to the implant.

[0108] FIG. 64 illustrates gear 5850 of the gear box, according to an embodiment of the present disclosure. In this illustrated embodiment, the gear 5850 may include an elongated body 5852 having an inner central passageway 5854 and a plurality of outer teeth 5856. Each of the teeth may extend from one end of the body 5852 to the other end of the body 5852. For example, the teeth may be splines that extend the length of the body 5852. The pin 5860 (FIG. 58) is receivable in the inner central passageway 5854.

[0109] FIG. 65 is an enlarged side view of the distal ends of the elongated housing assembly 5310, the rotatable drive pinion assembly 5360, and rotatable inner shaft assembly 5370, according to an embodiment of the present disclosure. In this illustrated embodiment, drive pinion assembly 5360 includes the drive pinion 5364 having a plurality of outer teeth 5366.

[0110] As shown in FIG. 66, the plurality of outer teeth 5366 of the drive pinion assembly 5360 mesh or match up with the plurality of outer teeth 5856 of the gears 5850 of the gear box. The plurality of outer teeth 5366 of the drive pinion assembly 5360 transmit a torque to the plurality of gears 5850 of the gear box, which plurality of gears 5850 transmit a torque to the plurality of screws 5200, as shown in FIG. 67. As described below in connection with the installation of the implant, the teeth of the plurality of gears 5850 of the gear box provide both rotational and linear motion to the plurality of screws. In some embodiments, the plurality of outer teeth 5366 of the drive pinion assembly 5360 and the plurality of gears 5850 of the gear box may have a helical or straight configuration. For example, helical splines may offer better smoothness and synchronization during rotation. The helical angle may reduce shock loads, improving the smoothness during installation compared to straight splines, which may generate greater vibration and noise during rotation.

[0111] FIGS. 68-73 illustrate a process for installing an implant, for example, in a patient’s lumbar spine, according to the embodiment of the present disclosure. For example, initially an implantation site 20 in the spine 50 in the patient is prepared forreceiving an implant as shown in FIG. 68. In other embodiments, an implantation site may be sized and configured in connection with the thoracic and / or cervical spine. From the present disclosure, it will be appreciated that various sized and configured implants and instruments may be employed, for example for use in cervical, thoracic, and lumbar implants.

[0112] As shown in FIG. 69, the inserter 5300, the implant 5100, and the plurality of screws 5200 may be preassembled prior to introducing the implant 5100 into the implantation site in the patient. For example, the implant 5100 may be operably attached to the inserter 5300 using rotatable inner shaft assembly 5370. The plurality of screws 5200 may then be operably inserted into the gear box 5800. In some embodiments, the implant 5100 may include at least one or a plurality of cutouts 5140 (also shown in FIGS. 52 and 53) disposed along the anterior side 5129 (51329 (FIG. 53) of the implant. The gear case 5810 of gear box 5800 may include a plurality of projections (not shown) that are receivable in the cutouts 5140 that aid in preventing implant 5100 from rotating when rotatable inner shaft assembly 5370 (FIG. 56) is attached to the implant 5100. It will be appreciated that other configurations and placement may be employed for locking or interlocking portions of the gear case and implant in an effort to inhibit rotation therebetween.

[0113] With reference to FIG. 70, the preassembled inserter 5300 (illustrated in FIG. 70 without the gear case), the implant 5100, and the plurality of screws 5200 is positioned with the implant 5300 aligned with the implant location site 20. As shown in FIG. 71 , the implant 5100 may be moved in the direction of arrow X (FIG. 70) into and received in the implantation site 20 (FIG. 70). In the case of FIGS. 68-73, the implantation site is an intervertebral disc space. In other embodiments, other implant locations in a patient’s body and implants employing the technique of the present disclosure may be prepared for such implant, for example, in the fusion of articular joints or osteotomy sites in the hand, feet, limbs and pelvis.

[0114] With reference again to FIG. 71 , the inserter 5300 is operated by the surgeon to install the implant 5100 in the installation site 20 (FIG. 70), according to an embodiment of the present disclosure. For example, the surgeon may hold theelongated housing assembly 5310 stationery and in a fixed position relative to the installation site and the patient. The surgeon may then manually operate the ratcheting or non-ratcheting handle 5366 (FIG. 44 and 59), e.g., rotate handle 5366 clockwise in the direction of arrow R5 (FIG. 44), which turns rotates, in the direction of arrow R5 as shown in FIG. 71 , the hollow shaft 5362 of drive pinion assembly 5360 and drive pinion 5364. Rotation of drive pinion 5364 causes gears 5850 to rotate counterclockwise about their axis in the direction of arrow R6. Rotation of gears 5850 cause the plurality of screws 5200 to rotate clockwise in the direction of R7. Rotation of drive pinion 5364 and gears 5850 causes the plurality of screws 5200 disposed in a first position shown in FIG. 71 to simultaneously rotate until the plurality of screws 5200 are disposed in a second installed position as shown in FIG. 72.

[0115] Thereafter, the inserter 5300 is removed and / or disconnected from the implant 5100, e.g., the handle 5376 (FIG. 44 and 56) of the rotatable inner shaft assembly 5370 (FIG. 44 and 56) is rotated counterclockwise, leaving the implant 5100 and screws 5200 installed in the installation site in the patient as shown in FIG. 73. In some embodiments, the surgeon may need to do an additional final tightening step to completely seat the screws within the implant. In further embodiment, a suitable locking mechanism may be employed to inhibit or prevent the screws from moving one installed and the inserter is removed from the implant. For example, one or more components may be employed and threadably attached to threaded opening 5130 (FIG. 53) and engageable with head portion 5240 (FIGS. 54 and 55) of the plurality of screws (FIGS. 54 and 55). In further embodiment, the head of the screws and the recessed portions of the implant may be sized so that the head of the screws is disposed essentially in the implant and do not extend appreciably from the surface of the implant.

[0116] Inserter 5300 may be employed in the method 4000 described above and shown in FIG. 43. In another embodiment, In other embodiments, inserter 5300 may be motorized, e.g., having a motor and a switch as described above, allowing for automatically simultaneously rotating and installing the screws during installation of the implant 5100.

[0117] FIG. 74 illustrates a method 6000 for installing an implant in an installation site, according to an embodiment of the present disclosure. Exemplary method 6000 may include at 6100 providing an inserter having gear box with a plurality of passageways, at 6200 connecting the implant to the inserter, at 6300 inserting a plurality of screws in the plurality of passageways in the gear box, at 6400 using the inserter to insert the implant with the plurality of screws into an installation site in a patient, at 6500 operating the inserter to simultaneously rotate the plurality of screws into the installation site from a first position relative to the implant in which the distal ends of the plurality of screws are disposed in the implant to a second position relative to the implant with the distal ends of the plurality of screws extend from the implant and into the installation site, and at 6600 disconnecting the inserter from the implant.

[0118] It will be appreciated that the installation of the implant with screws using the inserter may provide a more secure and reliable installation compared to using bone spikes, bone blades, or bone nails.

[0119] As will be appreciated from the present description, the present disclosure can be scaled appropriately to address the problem of instability caused by, for example, ilio-sacral instability which can be addressed by placing the implant of the present disclosure into the articular space between the sacrum and the illium of the pelvis for the purpose of fusion. This location is known as the sacroiliac (SI) joint. Other potential applications include fusing articular joints in the hands, feet and extremities. Additionally, it is contemplated that such an implant may be configured to be used to stabilize a corrective osteotomy of the tibia, femur, pelvis and other bones.

[0120] As may be recognized by those of ordinary skill in the art based on the teachings herein, numerous changes and modifications may be made to the abovedescribed and other embodiments of the present invention without departing from the scope of the invention. The implants, screws, gears and other components of the devices and / or apparatus as disclosed in the specification, including the accompanying abstract and drawings, may be replaced by alternative component(s) or feature(s), such as those disclosed in another embodiment, which serve the same, equivalent or similar purpose as known by those skilled in the art to achieve the same, equivalent or similarresults by such alternative component(s) or feature(s) to provide a similar function for the intended purpose. In addition, the devices and apparatus may include more or fewer components or features than the embodiments as described and illustrated herein. Accordingly, this detailed description of the currently-preferred embodiments is to be taken as illustrative, as opposed to limiting the invention.

[0121] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprise" (and any form of comprise, such as "comprises" and "comprising"), "have" (and any form of have, such as "has", and "having"), "include" (and any form of include, such as "includes" and "including"), and "contain" (and any form of contain, such as "contains" and "containing") are open-ended linking verbs. As a result, a method or device that "comprises," "has," "includes," or "contains" one or more steps or elements possesses those one or more steps or elements, but is not limited to possessing only those one or more steps or elements. Likewise, a step of a method or an element of a device that "comprises," "has," "includes," or "contains" one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.

[0122] The invention has been described with reference to the preferred embodiments. It will be understood that the architectural and operational embodiments described herein are exemplary of a plurality of possible arrangements to provide the same general features, characteristics, and general apparatus operation. Modifications and alterations will occur to others upon a reading and understanding of the preceding detailed description. It is intended that the invention be construed as including all such modifications and alterations.* * * * *

Claims

CLAIMS:1 . A system comprising: an implant having a plurality of passageways; a plurality of screws, each having a threaded portion receivable in a different one of the plurality passageways in the implant; and an inserter for simultaneously rotating the plurality of screws from a first position relative to the implant in which distal portions of the plurality of screws are disposed in the implant to a second position relative to the implant in which the distal portions of the plurality of screws extend from the implant.

2. The system of claim 1 , wherein the inserter comprises: a gear box comprising: a gear case; and a plurality of gears, each of which is operably engageable with a different one of the plurality of screws.

3. The system of claim 1 , wherein the inserter comprises: a gear box comprising: a gear case having a plurality of chambers for use in supporting a plurality of gears, the plurality of chambers defining a plurality of axes; and the gear case having a plurality of passageways for receiving the plurality of screws, the passageways defining a plurality of axes parallel to the plurality of axes of the plurality of chambers.

4. The system of claim 1 , wherein the inserter comprises: a gear box comprising: a gear case; and a plurality of gears, each of which is operably engageable with a different one of the plurality of screws; anda single drive pinion engageable with the plurality of gears, which plurality of gears is operable to rotate the plurality of screws.

5. The system of claim 4, wherein: the single drive pinion comprises helical teeth, the plurality of gears comprises an elongated rotatable body having a plurality of elongated helical teeth engageable with the single drive pinion; and wherein the elongated helical teeth are operable for rotating and linearly moving the plurality of screws.

6. The system of claim 1 , wherein the inserter comprises: a rotatable attachment assembly comprising: an elongated shaft having first end and a second end, the first end comprising threads for releasably attaching to the implant, and a second end attached to a first handle; a drive pinion assembly comprising: a hollow elongated shaft having a first end and a second end, the first end attached to a drive pinion, and a second end attached to a second handle. a housing assembly comprising: a hollow elongated shaft having first end and a second end; a gear box attached to the first end of the hollow elongated shaft; and wherein the rotatable attachment assembly is receivable in the drive pinion assembly, and the drive pinion assembly is receivable in the housing assembly.

7. The system of claim 1 , wherein the inserter comprises: a single pinion directly engageable with the plurality of screws for rotating the plurality of screws.

8. The system of claim 7, wherein: the plurality of screws comprise a head portion having a plurality of teeth; and the single pinion is engageable with plurality of teeth of the plurality of screws.

9. The system of claim 1 , wherein the inserter comprises: a plurality of pinions each of which is separately engageable with a different one of the plurality of screws.

10. The system of claim 9, wherein: the plurality of pinions comprises a semi-spherical gear; and each of the screws comprises a socket engageable with the semi- spherical gear.1 1 . The system of claim 1 , wherein: the implant comprises a plurality of rotatable inserts disposed in the passageways; and the plurality of rotatable inserts is operable for rotating the plurality of screws.

12. The system of claim 1 , wherein the inserter comprises: a rotatable handle; a gear mechanism; the rotatable handle operable to rotate the gear mechanism; and the gear mechanism operable to rotate the plurality of screws.

13. The system of claim 12, wherein the gear mechanism comprises: a plurality of gears.

14. The system of claim 12, wherein the gear mechanism comprises a step down transmission.

15. The system of claim 12, wherein: the gear mechanism comprises a hollow cylinder with internal teeth; and the rotatable handle is connected to the hollow cylinder with the internal teeth.

16. The system of claim 1 , wherein the inserter comprises at least one pinion comprising helical teeth.

17. The system of claim 1 , wherein the implant, the plurality of screws, and the inserter are operable as a preassembled single unit.

18. The system of claim 1 , wherein: the implant comprising a first surface and a second surface, a first passageway opening onto the first surface and a second passageway opening onto the second surface; the plurality of screws comprising a first screw and a second screw receivable in the plurality of passageways; and the first screw having a first orientation, and the second screw having a second orientation different from the first orientation.

19. The system of claim 1 , wherein the implant is sized and configured for positioning between vertebrae and the plurality of screws is sized and configured for attaching the implant to the vertebrae.

20. The system of claim 1 , wherein the inserter comprises: a handle; and wherein rotation of the handle in a first direction is operable to rotate the screws in a second opposite direction.21 . The system of claim 1 , wherein the inserter comprises: a handle; and wherein rotation of the handle in a first direction is operable to rotate the screws in a second direction the same as the first direction.

22. The system of claim 1 , wherein the inserter comprises: a handle; and wherein rotation of the handle in a first direction is operable to rotate the screws in the same direction.

23. The system of claim 1 , wherein: the plurality of screws comprises a plurality of bone screws.

24. The system of claim 1 , wherein: the inserter comprises a motor operable for automatically and simultaneously rotating the plurality of screws.

25. The system of claim 24, wherein: the inserter comprises a battery.

26. An inserter operably releasably attachable to an implant having a plurality of screws, the inserter comprising: a housing; at least one rotatable member disposed in the housing, the at least one rotatable member having a first end and a second end; at least one pinion attached to the first end of the at least one rotatable member, the at least one pinion operably engageable with the plurality of screws; and wherein the inserter is operable to simultaneously rotate the plurality of screws from a first position relative to the implant in which the distal portions of the plurality of screws are disposed in the implant to a second position relative to the implant with the distal portions of the plurality of screws extending from the implant.

27. The inserter of claim 26, further comprising: a gear box attached to the housing, the gear box comprising: a gear case; and a plurality of gears, each of which is operably engageable with the at least one pinion and operably engageable with a different one of the plurality of screws.

28. The inserter of claim 26, further comprising: a rotatable attachment assembly disposed in the housing, the rotatable attachment assembly comprising: an elongated shaft having first end and a second end, the first end comprising threads for releasably attaching to the implant, and a second end attached to a first handle; a hollow elongated shaft having a first end and a second end, the first end attached to the at least one pinion, and a second end attached to a second handle; and wherein the housing comprises: a hollow elongated shaft having first end and a second end; a gear box attached to the first end of the hollow elongated shaft; and wherein the rotatable attachment assembly is receivable in the drive pinion assembly, and the drive pinion assembly is receivable in the housing assembly.

29. The system of claim 26, wherein the at least one pinion comprises a single pinion directly engageable with the plurality of screws for rotating the plurality of screws.

30. The system of claim 26, wherein the at least one pinion comprises a plurality of pinions each of which is separately engageable with a different one of the plurality of screws.31 . The system of claim 26, wherein the at least one pinion comprises at least one pinion having helical teeth.

32. The inserter of claim 26, further comprising a handle attached to the second end of the at least one rotatable member.

33. The system of claim 26, wherein the inserter further comprises: a motor operable for automatically and simultaneously rotating the plurality of screws.

34. A method comprising: providing the system of claim 1 ; inserting the implant with the plurality of screws into an installation site of a patient; simultaneously rotating the plurality of screws into the installation site in the patient; and disconnecting the inserter from the implant.

35. A method comprising: providing an inserter connected to an implant having a plurality of screws disposed in a plurality passageways in the implant; inserting the implant with the plurality of screws into an installation site of a patient; simultaneously rotating the plurality of screws into the installation site in the patient; and disconnecting the inserter from the implant.

36. The method of claim 35, wherein the simultaneously rotating comprises: rotating a pinion having teeth operably engageable with at least one of the plurality of screws.

37. The method of claim 35, wherein the simultaneously rotating comprises: rotating a single pinion operably engageable with and operable for rotating the plurality of screws.

38. The method of claim 35, wherein the simultaneously rotating comprises: manually operating the inserter to simultaneously rotate the screws.

39. The method of claim 35, wherein the simultaneously rotating comprises: automatically operating the inserter to simultaneously rotate the screws.

40. The method of claim 35, wherein the simultaneously rotating comprises: using a motor to drive the simultaneous rotation of the screws.41 . The method of claim 40, wherein the motor is battery powered.

42. A method comprising: providing an inserter having a gear box connected to an implant and a plurality of screws disposed in a plurality passageways in the implant; operating the inserter to simultaneously rotate the plurality of screws from a first position relative to the implant in which distal portions of the plurality of screws are disposed in the implant to a second position relative to the implant with the distal portions of the plurality of screws extending from the implant; and disconnecting the inserter from the implant.

43. The method of claim 42 wherein the operating comprises: rotating a drive pinion assembly of the inserter to rotate a single rotatable pinion, which single rotatable pinion is operable to simultaneously rotate a plurality of gears of the gear box, which in turn simultaneously rotate the plurality of screws.

44. The method of claim 42, wherein the gear box comprises: a gear case having a plurality of chambers for use in supporting the plurality of gears, the plurality of chambers defining a plurality of axes; and a plurality of passageways for receiving the plurality of screws, the passageways defining axes parallel to the axes of the plurality of chambers.

45. The method of claim 44, wherein the each of the plurality of gears comprises: an elongated rotatable body having a plurality of elongated teeth for rotating and linearly moving the plurality of screws.

46. The method of claim 45, wherein: the plurality of elongated teeth comprises a plurality of elongated helical teeth.

47. The method of claim 42, wherein the inserter comprises: a rotatable attachment assembly comprising: an elongated shaft having first end and a second end, the first end comprising threads for releasably attaching to the implant, and a second end attached to a first handle; a drive pinion assembly comprising: a hollow elongated shaft having a first end and a second end, the first end attached to a drive pinion, and a second end attached to a second handle. a housing assembly comprising: a hollow elongated shaft having first end and a second end; a gear box attached to the first end; and wherein the rotatable attachment assembly is receivable in the drive pinion assembly, and the drive pinion assembly is receivable in the housing assembly.

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