US20100305704A1 - Intervertebral implant with fixation geometry - Google Patents

Abstract

An intervertebral spacer implant (80) is provided with a retention mechanism (86) to help alleviate expulsion and movement of the implant when placed in the spine while providing an implant that is easier to insert in the spine. In one embodiment the retention mechanism comprises a keel on at least one of the inferior or superior faces of the spacer implant preferably extending in an anterior-posterior direction. In another embodiment the implant comprises a spacer (84) and a plate (82), the plate comprising a supplemental or alternative retention mechanism. In one embodiment the retention mechanism comprises one or more holes (88) in the anterior end of the plate. In yet another embodiment, the retention mechanism comprises one or more blades that are in a first position when inserted and are preferably rotated to a second position that engages the superior and inferior vertebrae.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• The present application claims priority to U.S. Provisional Application Nos. 60/777,732 filed Feb. 27, 2006, 60/777,663 filed Feb. 27, 2006, and 60/838,229 filed Aug. 16, 2006, the entire contents of which are expressly incorporated herein by reference thereto.
FIELD OF THE INVENTION
• The present invention relates generally to intervertebral implants, and, more particularly, to a zero or low profile fusion implant including a retention mechanism that preferably provides integrated fixation geometry.
BACKGROUND OF THE INVENTION
• Implants for use in spinal fusion surgery are known in the art. Such implants are used to stabilize and immobilize the spinal segments in the treatment of degenerative disc disease (single and multi-level), spinal stenosis, and failed previous fusions. Some implants use supplemental fixation means, such as a plate and screws, to retain the implant once introduced between two vertebrae.
SUMMARY OF THE INVENTION
• The present invention preferably provides for an integrated retention mechanism and spacer implant construction. As such, the implant of the present invention preferably may be inserted using a one-step implantation process, as compared to a two-step process. The present invention preferably allows for implantation of an intervertebral implant and fusion of adjacent vertebrae without the need for additional supplemental fixation means. Preferably, such an implant will minimize dysphasia and irritation of soft tissue, provide sufficient segmental stability in flexion, extension and rotation, provide adequate graft retention, allow for reduced surgery times, minimize surgical trauma, and still allow for additional anterior and/or posterior fixation, if necessary. In one embodiment, the implant may comprise a spacer having a first insertion end portion, a second end portion opposite the first insertion end portion, a first lateral side portion, a second lateral side portion, an upper surface, and a lower surface. The spacer configured and dimensioned for insertion between vertebrae. The Spacer may optionally have one or more keels formed on one of the upper and lower surfaces of the spacer. The keel preferably extends from the first insertion end portion toward the second end portion at least about 50 percent of the distance between the first insertion end portion and the second end portion. Preferably, the keel extends at least about 80 percent, and more preferably 95 percent of the distance between the first insertion end portion and the second end portion.
• The keel may have a first insertion end and a second end where the first insertion end may be wedge shaped. The keel may have a plurality of projections that are saw-tooth shaped. The keel may have a first insertion end and a second end portion and the first insertion end of the keel starts at about the first insertion end portion of the implant. The keel may be tapered so that it is higher at its second end relative to the insertion end. The keel preferably has a height of about 1 mm to about 3.5 mm and preferably a width of about 0.5 mm to about 3 mm.
• The implant in one embodiment may be formed of an anterior plate secured to the second end portion of the spacer, the plate formed of a different material than the spacer. The plate is preferably formed of a metallic material and the spacer is preferably formed of a non-metallic material. The plate may include at least two through holes, the at least two holes configured to receive screws for securing the implant to adjacent vertebrae and defining first and second hole axes; wherein the first through hole exits through the upper surface and the second through hole exits through the lower surface, and the axes of the first and second through holes form non-zero angles with respect to the upper and lower surfaces.
• The plate preferably does not extend beyond the perimeter of the spacer, and more preferably the height of the plate is no more than the height of the spacer at the second end so that the plate does not increase the height profile of the spacer. In this manner the Spacer-plate construct may have a low profile. The through holes in the plate at its outer surface may be generally aligned along a straight line that generally corresponds with the mid-plane of the implant. The spacer and plate preferably are secured together before insertion into the spine. In one embodiment the plate and spacer are connected by at least one dovetail connection, the dovetail connection preferably extends from the upper surface to the lower surface, although the dovetail may extend in a horizontal direction when the spacer is inserted in the spine. The spacer may be solid, or alternatively the spacer may have vertical or horizontal windows or channels. The spacer or plate and spacer construct may have a plurality of projections formed on at least the upper or lower surface, the projections preferably having a height less than the height of the keel. The keel in one embodiment may be formed only on the spacer.
• In yet another embodiment the intervertebral implant may comprise a spacer having a first insertion end portion, a second end portion, a first lateral side portion, a second lateral side portion, an upper surface, and a lower surface, wherein the spacer configured and dimensioned for insertion between vertebrae; a plate secured to the first end of the spacer, the plate including at least two through holes defining first and second central hole axes, the at least two holes configured and dimensioned to receive screws for securing the implant to adjacent vertebrae; and at least one keel extending along the upper or lower surface and extending at least 50% of the length of the upper or lower surface between the insertion end portion and the second end portion, wherein the first and second central hole axes form non-zero angles with respect to the upper and lower surfaces of the spacer.
• In another embodiment, the intervertebral implant may comprise a spacer having a first insertion end portion, a second end portion, an upper surface, and a lower surface, wherein the spacer is configured and dimensioned for insertion between vertebrae; a Plate secured to the second end portion of the spacer, the plate including one or more blades, preferably two blades, configured and dimensioned to penetrate adjacent vertebrae; and an actuator for causing the one or more blades to move to penetrate adjacent vertebrae. The one or more blades may be configured to rotate from a first position wherein the blades preferably are adjacent the plate to a second position wherein the blades preferably are not adjacent the plate. The blades preferably are configured to provide compression between the vertebrae and the implant as the blades are rotated into the second position. The implant may further comprise a locking mechanism to prevent the blades from rotating back to the first position.
BRIEF DESCRIPTION OF THE DRAWINGS
• The intervertebral implant is explained in even greater detail in the following exemplary drawings. The drawings are merely exemplary to illustrate the structure of preferred implants and certain features that may be used singularly or in combination with other features. The invention should not be limited to the embodiments shown.
• FIG. 1A is a perspective view of an intervertebral implant according to one embodiment of the present invention positioned between adjacent vertebral bodies;
• FIG. 1B is a side view of the implant shown inFIG. 1A;
• FIG. 1C is a front view of the implant shown inFIG. 1A;
• FIG. 2A is a perspective view of an intervertebral implant employing two retention screws according to another embodiment of the present invention;
• FIG. 2B is a top view of the implant shown inFIG. 2A;
• FIG. 2C is a side view of the implant shown inFIG. 2A;
• FIG. 3A is a perspective view of an intervertebral implant employing three retention screws according to still another embodiment of the present invention;
• FIGS. 3B and 3C are front and side views, respectively, of the implant shown inFIG. 3A;
• FIGS. 4A and 4B are side and front views, respectively, of the implant shown inFIG. 3A, in position between vertebrae;
• FIG. 5A is a perspective view of an intervertebral implant employing four retention screws according to still another embodiment of the present invention;
• FIGS. 5B and 5C are front and side views, respectively, of the implant shown inFIG. 5A;
• FIG. 5D is a perspective view of two of the implants ofFIG. 5A positioned between vertebrae;
• FIG. 6A is a perspective view of an intervertebral implant employing top and bottom keels and two retention screws according to still another embodiment of the present invention;
• FIGS. 6B and 6C are front and back views, respectively, of the implant shown inFIG. 6A;
• FIG. 6D is another perspective view of the implant shown inFIG. 6A;
• FIGS. 7A and 7B are top views of an implant employing a dovetail connection between a plate and spacer;
• FIG. 8 is a perspective view of an implant employing a dovetail connection between a plate and spacer;
• FIG. 9 is a top view of an implant employing two dovetail connections between the plate and spacer;
• FIGS. 10A and 10B are top and side views, respectively, of an implant employing a dovetail connection running horizontally between the plate and spacer;
• FIGS. 11A and 12A are top views of implants employing a plate and spacer where the plate sides wrap around a portion of the spacer;
• FIGS. 11B and 12B are perspective views of the plates ofFIGS. 11A and 12A, respectively;
• FIG. 13 is a top view of an implant employing a “jigsaw puzzle” connection between the plate and spacer;
• FIG. 14A is a perspective view of an implant wherein the plate and spacer are integrally formed with one another;
• FIGS. 14B-14E are rear, front, side and top views of the implant depicted inFIG. 14A;
• FIG. 14F is a side view of the implant depicted inFIG. 14A, in position between adjacent vertebrae;
• FIG. 15A is a perspective view of an intervertebral implant employing top and bottom keels according to yet another embodiment of the present invention;
• FIGS. 15B-15D are front, side and top views, respectively, of the implant depicted inFIG. 15A;
• FIG. 16A is a perspective view of an intervertebral implant employing top and bottom keels according to yet another embodiment of the present invention;
• FIG. 16B is a side view of the implant depicted inFIG. 16A;
• FIG. 17A is a perspective view of an intervertebral implant employing top and bottom keels according to yet another embodiment of the present invention;
• FIG. 17B is a side view of the implant depicted inFIG. 17A;
• FIG. 18 is a perspective view of an intervertebral implant employing top and bottom keels according to yet another embodiment of the present invention; and
• FIG. 19 is a perspective view of an intervertebral implant employing top and bottom keels according to still another embodiment of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• Referring generally toFIGS. 1A,1B and1C, anintervertebral implant10 according to an embodiment of the present invention is illustrated. As known in the art, theimplant10 is inserted between adjacent vertebra (shown schematically as50 inFIGS. 1A-1C) of the spinal column. In this embodiment, the implant includes aplate11 and a graft/spacer12 combined with aretention mechanism14. As shown,implant10 includes anupper surface16 and alower surface18, which may taper, be curved, arcuate or flat as desired or to conform to the end plates of the vertebrae and the intervertebral space. As shown, upper andlower surfaces16,18 may include a series of teeth orsimilar projections19 to aid in securing the implant to the vertebral endplates.
• In addition, the implant includesretention mechanism14 which preferably has two wedge-shapedblades20, although more orless blades20 may be included. Following implantation between vertebrae,retention mechanism14 is torsionally driven intovertebral bodies50 and rotationally locked. More particularly, wedge-shapedblades20 may be rotated to engage, penetrate or cut through the endplates ofvertebral bodies50 to holdimplant10 in position.Wedges20 preferably are pointed and shaped to facilitate penetrating the end plates. Preferably, retention mechanism has arecess15 or projection (not shown) to receive a tool to rotateretention mechanism14 relative to plate11 andspacer12. Preferably,retention mechanism14 includes a locking mechanism23 to prevent rotation ofblades20 or otherwise lock the position of theblades20 in the vertebrae.Retention mechanism14 may have a hub (not shown) that projects into and is held in a cavity (not shown) in theplate11. The hub is held or retained in the cavity, but may rotate relative to the plate.Recess15 is preferably star-shaped and formed in the hub.
• In the insertion position the pointedtips17 on theblades20 are directed toward the vertebrae. In the embodiment shown, one pointedtip17 is directed toward the superior vertebrae and one pointedtip17 is directed toward the inferior vertebrae. After theimplant10 is positioned between the vertebrae, the retention mechanism is rotated clockwise so that the pointedtips17 preferably are directed in the lateral/medial direction. In the preferred embodiment, the retention mechanism is rotated approximately 90°, although the retention mechanism may be rotated by more or less angular amounts. As the blades are rotated they engage, penetrate into, or cut through the vertebrae. The blades are preferably wedge-shaped and preferably compress the adjacent vertebrae together or towards one another as they are rotated.
• Implant10 may also includeopenings22 for additional fixation screws, if necessary.Openings22 may also permit screws that permit theplate11 to be attached to thespacer12. Bothplate11 and graft/spacer12 may be formed of PEEK, titanium, titanium alloy, stainless steel, allograft bone or any other suitable, biocompatible material. Preferablyplate11 andretention mechanism14 are formed of metal or metal alloy and the spacer is formed of PEEK or other polymer, or alternatively bone or ceramic or radiolucent biocompatible material. Screws (not shown) may be formed of titanium, titanium alloy or stainless steel. Graft/spacer12 may include one or more openings (not shown) designed to receive bone graft material.
• Reference is now made toFIGS. 2A,2B and2C, which show anintervertebral implant30 according to another embodiment of the present invention.Implant30 includes aplate32 and a spacer/graft34. As shown, in this embodiment, the retention mechanism is provided by screws that provide opposing screw fixation. In other words, for example, one screw diverges outward such that it is secured into an upper or superior vertebra and another screw diverges outward from the implant such that it is secured in a lower or inferior vertebra so that opposing forces act on the plate and/or vertebrae. A pair of holes oropenings36 accept twoscrews38, which penetrate the vertebral bodies and secure the implant in place. One ofholes36 is angled upward toward the upper or superior vertebrae, and theother hole36 is angled downward toward the lower or inferior vertebrae, such that holes36 form an angle with respect to the upper andlower surfaces26,28 of theimplant30. As shown best inFIG. 2C, holes36 form an angle α with respect to the upper and lower surfaces of the implant, where α may range between 20° and 50°, and preferably ranges between 30° and 45°. Angle α may be the same for allholes36 or may be different for each hole. After the implant is placed between adjacent vertebrae, screws38 are inserted through theholes36 inplate32 to penetrate the vertebrae and hold the implant in position, i.e., one screw is inserted into the upper vertebrae and the other is inserted into the lower vertebrae. As with the previous embodiment, upper and/orlower surfaces26,28 of the implant may include a series ofteeth19, or other similar projections, to aid in securing the implant to the vertebral endplates. Bothplate32 and graft/spacer34 may be formed of PEEK, titanium, titanium alloy, stainless steel, allograft bone or any other suitable, biocompatible material, or any combination thereof.Screws38 may be formed of titanium, titanium alloy or stainless steel. Graft/spacer34 may include one ormore openings33 designed to receive bone graft material.
• Plate32 is preferably formed of metal or metal alloy and thespacer34 is preferably formed of PEEK or other polymer, or bone (allograft) or ceramic or other radiolucent, biocompatible material. Theplate32 preferably is of the same height or less than the height of thespacer12 so the implant has a low profile. The plate is preferably connected to thespacer12 before theimplant10 is implanted. Preferably theholes36 are formed substantially along a single substantiallyhorizontal line5 or plane in the plates. The line or plane along which theholes36 are formed in the outer surface of theplate32 is preferably substantially themid-plane5 of the implant. In the embodiment ofFIGS. 2A-2C, theexit openings37,39 for the screw holes36 are formed in the plate. Theplate32 is preferably connected to thespacer34 by a dovetail joint31 that requires theplate32 to the slide vertically relative to thespacer34.
• Reference is now made toFIGS. 3A,3B and3C, which show anintervertebral implant40 according to still another embodiment of the present invention. As with the embodiment shown inFIG. 2A,implant40 includes aplate42 and a spacer/graft44, and the retention mechanism is provided by screws that provide opposing screw fixation. As shown, threeholes46 accept threefixation screws48, which penetrate the vertebral bodies and secure the implant in place, as shown inFIGS. 4A and 4B. As shown best inFIG. 3C, holes46 form an angle α with respect to the upper andlower surfaces41,45 of the implant, where α may range between 20° and 50°, and preferably ranges between 30° and 45°. Angle α may be the same for allholes46 or may be different for each hole. After the implant is placed between adjacent vertebrae, screws48 are inserted through theholes46 inplate42 to penetrate the vertebrae and hold the implant in position. In this embodiment, onescrew48 penetrates the upper vertebrae and twoscrews48 penetrate the lower vertebrae. As with the previous embodiment, upper and/orlower surfaces41,45 of theimplant40 may include a series ofteeth19, or other similar projections, to aid in securing the implant to the vertebral endplates. Bothplate42 and graft/spacer44 may be formed of PEEK, titanium, titanium alloy, stainless steel, allograft bone or any other suitable, biocompatible material, or any combination thereof.Screws48 may be formed of titanium, titanium alloy or stainless steel. Graft/spacer44 may include one ormore openings43 designed to receive bone graft material.
• Plate42 is preferably formed of metal or metal alloy andspacer44 is preferably formed of PEEK, other polymer, bone, ceramic or other radiolucent, biocompatible material. Theplate32 preferably is the same height or less than the height of the spacer. As withimplant30,plate42 is preferably connected to spacer44 prior to implantation and holes46 are preferably formed substantially along a substantially horizontal line in theouter end surface43 of theplate42 at an angle α so that at least two fixation screws are directed in opposed directions, one toward the superior vertebrae and one toward the inferior vertebrae. In the embodiment ofFIGS. 3A-3C, theexit openings47,49 in the superior and inferior surfaces for the screws are preferably formed at the junction of the plate and spacer, or in the spacer. Alternatively, like the embodiment ofFIGS. 2A-2C, theexit openings47,49 may be formed entirely with in theplate42.
• The superior surface, the inferior surface or both surfaces of the spacer and the implant construct may have a curved surface to help provide the proper shape to the spine. The particular surface shape and curvature, or taper in the anterior-posterior direction as well as between the lateral side surfaces will depend upon the location the spacer is intended to be inserted. The shape of the perimeter of the spacer shown inFIGS. 2-14 are generally for cervical applications and the spacer may have an alternative shape, such as that illustrated by the perimetral shape ofFIG. 15 for other locations such as in the lumbar area of the spine.
• Reference is now made toFIGS. 5A,5B and5C, which show anintervertebral implant60 according to still another embodiment of the present invention. As with the embodiment shown inFIG. 3A,implant60 includes aplate62 and a spacer/graft64, and the retention mechanism is provided by screws which provide opposing screw fixation. As shown, fourholes66 accept fourfixation screws68, which penetrate the vertebral bodies and secure theimplant60 in place, as shown inFIG. 5D. As shown best inFIG. 5C, holes66 form an angle α with respect to the upper andlower surfaces61,65 of theimplant60, where α may range between 20° and 50°, and preferably ranges between 30° and 45°. Angle α may be the same for allholes66 or may be different for each hole. After the implant is placed between adjacent vertebrae, screws68 are inserted through theholes66 inplate62 to penetrate the vertebrae and hold the implant in position. In this embodiment, the twoinner screws68 penetrate the upper vertebrae and the twoouter screws68 penetrate the lower vertebrae. As with the previous embodiment, upper and/or lower surfaces of the implant may include a series ofteeth19, or other similar projections, to aid in securing the implant to the vertebral endplates. Bothplate62 and graft/spacer64 may be formed of PEEK, titanium, titanium alloy, stainless steel, allograft bone, or any other suitable, biocompatible material, or any combination thereof.Screws68 may be formed of titanium, titanium alloy or stainless steel. Graft/spacer64 may include one ormore openings63 designed to receive bone graft material. Preferably theplate62 is formed of a metal or metal alloy and thespacer64 is formed of PEEK, other polymer, bone allograft, ceramic or other radiolucent biocompatible material. Theholes66 are formed in theouter surface3 of the end wall of theplate62 substantially along a horizontal line or plane at an angle α.
• The screw holes66 in theplate62 preferably are directed outward from the center of the implant, preferably at an angle θ. The screw hole openings and configurations, as well as the screws may have the configuration and construction and materials described in US2005/0177236 which is incorporated by reference herein in its entirety. The screws inserted in the embodiments ofFIGS. 5A-5C do not intersect a vertical plane cutting theimplant60 into two substantial halves. The screws, and the screw holes, in the embodiment ofFIGS. 5A-5C on the left side, one of which extends in the superior direction and the other which extends in the inferior direction may extend laterally outward from the center plane at different angles θ, or at the same angle θ. Preferably the twooutermost holes66 in theimplant60 extend toward the inferior vertebrae while the two inner screw holes66 extend toward the superior vertebrae.
• FIGS. 6A-D show anintervertebral implant80 according to yet another embodiment of the present invention. As with the embodiments shown inFIGS. 2A,3A and5A,implant80 includes aplate82 and a spacer/graft84. However, in this embodiment, the retention mechanism is provided by a combination of opposingkeels86 on the top andbottom surfaces81,85 and screws providing opposing screw fixation. The upper andlower keels86 provide additional additive resistance to torsion or rotation of the implant. As shown, in addition to upper andlower keels86, a pair ofholes88 accept twofixation screws89, which penetrate the vertebral bodies and secure the implant in place. As with previous embodiments, holes88 form an angle α with respect to the upper and lower surfaces of the implant, where α may range between 20° and 50°, and preferably ranges between 30° and 45°. Angle α may be the same for allholes88 or may be different for each hole.
• After the implant is placed between adjacent vertebrae, screws89 are inserted through theholes88 inplate82 to penetrate the vertebrae and aid in holding the implant in position. As with previous embodiments, upper and/orlower surfaces81,85 of theimplant80 may include a series ofteeth19, or other similar projections, to aid in securing the implant to the vertebral endplates. Preferably, thekeel86 is at least as high as the teeth orprotrusions19. The keel preferably may have a height of about 1 mm to about 3.5 mm. Thekeel86 may have the shape shown inFIG. 86, although it may have the shapes shown inFIGS. 15-19, or other shapes. Thekeel86 preferably extends in the anterior-posterior direction. The leadingend85 of the keel may be pointed or tapered so that it gets wider from theposterior end83 to theanterior end83. The keel preferably may be about 0.5 mm to about 3.0 mm wide. The keel may also get higher as it extends from the posterior end to the anterior end. The taper in the height and width may permit easier insertion of the implant.
• Thekeel86 may only extend along the spacer as shown, or may extend along thespacer84 andplate82. The length of the keel may be, and preferably is, greater than the width of the keel. The length of thekeel86 is preferably greater than about 50 percent of the length of theimplant80 in the posterior to anterior direction and in some embodiments preferably greater than about 80 to about 95 percent of the length of theimplant80 in the anterior-posterior direction.
• Bothplate82 and graft/spacer84 may be formed of PEEK, titanium, titanium alloy, stainless steel, allograft bone, or any other suitable, biocompatible material, or any combination thereof, whilescrews89 may be formed of titanium, titanium alloy or stainless steel. Graft/spacer84 may include one or more openings (not shown) designed to receive bone graft material. As with the earlier embodiment the plate is preferably a different material than the spacer, and the plate is preferably a metallic material whereas the spacer is a non-metallic material. A preferred embodiment for theimplants10,30,40,60 and80 may include a titanium alloy for the plate and an allograft for the spacer.
• FIGS. 7A-13 depict various attachment mechanisms for attaching the plate and spacer of the implant together. The attachment mechanisms between spacer and plate are not limited to the mechanisms depicted. Various figures depict two or three holes of the retention feature of the implant. It should be noted that the number of holes two, three, or four of the retention feature of the implant is not limited by the type of attachment mechanism between the spacer and plate.
• FIGS. 7A and B depict a top view ofdovetail connection1010 betweenplate1100 and spacer1200 (These figures do not depict the holes of the retention feature so as to more clearly illustrate the dovetail connection1010). Thedovetail connection1010 may extend from the upper surface to the lower surface of theimplant1000. As shown in these figures, the thickness T of theplate1100 may vary depending on the application. Representative values for T include about 5 mm to about 7 mm. Furthermore, the size of thedovetail connection1010 may also vary in size, both in length and in width. As shown inFIGS. 7A and B, themale dovetail connector1011 is formed as part of theplate1100 while thefemale connector1012 is formed on thespacer1200. It is contemplated that the female connector may be formed on the plate and the male connector may be formed on the spacer.FIG. 8 is a perspective view of animplant1000 with adovetail connection1010 between theplate1100 andspacer1200. In this figure, theimplant1000 includes threeholes1110 similar to the embodiment depicted inFIGS. 3A-4B.
• FIG. 9 depicts animplant1000 having twodovetail connections1010,1020 between thespacer1200 andplate1100. In this embodiment, thedovetail connections1010,1020 may extend between the upper surface and lower surface of the implant. It is contemplated that the dovetail connections may extend from onelateral side1001 of theimplant1000 to the otherlateral side1002.FIGS. 10A and 10B depict such a dovetail connection between theplate1100 andspacer1200.
• FIGS. 11 and 12 depict further embodiments of the connection between theplate1100 andspacer1200. In these embodiments, thesides1110 of theplate1100 “wrap” around the proximal end (front) of thespacer1200. The length or thickness of thesides1110 of theplate1100 may vary, as depicted in the two figures, depending on the application.
• FIG. 13 depicts another embodiment of the connection between theplate1100 andspacer1200. In this embodiment, the connection between the plate and spacer is a “jigsaw puzzle”connection1040. The shape of the “jigsaw puzzle”connection1040 may vary depending on the application. As with the other embodiments discussed above, the male and female connectors of the connection may be formed on thespacer1200 orplate1100, depending on the application.
• FIGS. 14A-F depict a cervical spacer-plate implant2000.FIG. 14A is a perspective view of theimplant2000, whereasFIGS. 14B-E are various plane views of the implant. In this embodiment, theplate2020 andspacer2010 are integrally formed. Theimplant2000 may have anarcuate front face2100, whereas theend face2200 of the implant may be plane or arcuate. Theimplant2000 may also have arcuate first and secondlateral surfaces2300,2400, respectively, and an upper surface and alower surface2500,2600. Theupper surface2500 may be arcuate to conform to the contour of the endplate of the upper vertebra. Thelower surface2600 is generally a substantially flat planar surface. The distance between the upper andlower surfaces2500,2600 at thefront face2100 may be greater than at theend face2200. Thefront face2100 may be wider than theend face2200 such that the first and secondlateral surfaces2300,2400, connected to the front and end faces2100,2200 are further apart from each other at the front face than at the end face. Theimplant2000 may include one or more openings designed to receive bone graft material. In particular, one or more vertical windows/channels2700 may extend through the implant from thelower surface2600 to theupper surface2500. In some embodiments, theimplant2000 may also have one or morehorizontal channels2800 extending from the firstlateral surface2300 to the secondlateral surface2400, and/or from thefront face2100 to theend face2200.
• Thefront face2100 has a height greater than the height of thespacer2010 to accommodate a retention feature provided by opposing screw fixation. As shown, fourholes2900 accept fourfixation screws2950 which penetrate thevertebral bodies50 and secure theimplant2000 in place, as shown inFIG. 14F. Theholes2900 form an angle α with respect to the upper andlower surfaces2500,2600 of theimplant2000, where the angle may range between 20° and 50°, and preferably ranges between 30° and 45°. The angle α may be the same for all holes or may be different for each hole. After theimplant2000 is placed betweenadjacent vertebrae50,screws2950 are inserted through theholes2900 to penetrate the vertebrae and hold the implant in position. As with previous embodiments, the upper and/orlower surfaces2500,2600 of the implant may include a series ofteeth19, or similar projections, to aid in securing the implant to the vertebral endplates. It is also contemplated that the upper and/orlower surfaces2500,2600 may be smooth, having ridges that run laterally with respect to thespacer2010, or ridges running from thefront face2100 to theend face2200. Theimplant2000 may be formed of PEEK, titanium, titanium alloy, stainless steel, allograft bone, or any other suitable, biocompatible material, or any combination thereof, whilescrews2950 may be formed of titanium, titanium alloy or stainless steel.
• It should be noted that the screw holes provided in the plates of the embodiments ofFIGS. 2-14 may be threaded or smooth, and the screw inserted through the plate may have a head that also may be threaded or smooth. In the embodiment where the screw holes are threaded the heads of the screws are also preferably threaded so that the screw will lock with the plate forming a relatively rigid construct.
• Reference is now made toFIGS. 15A-D, which shows anintervertebral implant70 according to still another preferred embodiment of the present invention.FIG. 15A is a perspective view of the implant, whileFIGS. 15B-D are plane views of the implant. In this embodiment, a pair of opposing dovetail keels72 on the upper andlower surfaces71,73 of theimplant70 provide the retention feature. The implant may have arcuate anterior and posterior faces, both curved in the same direction to form a generally kidney bean shape. The keel is generally centrally located and preferably extends about 50 percent the length of the superior and inferior surfaces in an anterior to posterior direction, and more preferably about 80 to about 95 percent of the length in the anterior to posterior direction. The dovetail shape of thekeel72 preferably assists in retaining theimplant100 in position and helps to prevent expulsion of the implant. In particular, the dovetail shape will help to retain contact between the upper and lower surface of the implant and the end plates of the vertebrae. The dovetail shape may also be configured to provide compression. The shape of theimplant70 is generally preferred for the lumbar region of the spine.
• No additional plates or screws may be necessary.Implant70 may be formed of PEEK, titanium, titanium alloy, stainless steel, allograft bone, or any other suitable, biocompatible material, or any combination thereof.Implant70 may include one or more openings designed to receive bone graft material. In particular, one or more vertical windows/channels75 may extend through theimplant70 from thelower surface73 to theupper surface71. In some embodiments, theimplant70 may also have one or morehorizontal channels74 extending from a firstlateral surface77 to a secondlateral surface78, and/or from thefront face79ato theend face79b.
• Theimplant100, shown inFIGS. 16A and B, may have arcuate anterior and posterior faces110,112, respectively. Superior and inferior faces,114,116, respectively, may have projections orteeth118 for engaging the adjacent vertebrae and aiding in securing theimplant100 in the disc space. Theprojections118 may be pyramidal in shape as shown, or may have other shapes. One or more vertical windows/channels124, designed to receive bone graft material, may extend through theimplant100 from theinferior face116 to thesuperior face114. In some embodiments, theimplant100 may also have one or morehorizontal channels126 designed to receive bone graft material. The implant also haslongitudinal sides102,103, wherein a first longitudinal side's102 height may be, and preferably is, less than the height of the secondlongitudinal side103.
• Theimplant100 further may have a retention feature comprising afirst fixation member105 projecting from thesuperior face114 and asecond fixation member115 projecting from theinferior face116. The first andsecond fixation members105,115 resemble a “keel” such that the keel is oriented from theanterior face110 to the posterior face112. The length of the keel may be, and preferably is, greater than the width of the keel, and whose length preferably is 80 to 95 percent of the width of the superior andinferior faces114,116. The first andsecond fixation members105,115 have a height greater than the height of the projections orteeth118. The first andsecond fixation members105,115 may haveprojections106, such as in the form of a saw-tooth, for engaging the adjacent vertebrae and aiding in securing theimplant100 in the disc space without the need for supplemental fixation means. The saw-tooth shape of the projections allows the implant to be inserted while requiring a larger force for the implant to be removed from between vertebrae. The keel also helps prevent rotation or turning of the implant. No additional plates or screws may be necessary to retain the implant between two vertebrae.Implant100 may be formed of PEEK, titanium, titanium alloy, stainless steel, allograft bone, or any other suitable, biocompatible material, or any combination thereof.
• FIGS. 17A and B depict another embodiment of theimplant200. Theimplant100 may have end faces210,212, respectively. The end faces210,212 may be substantially flat or arcuate shaped. Face210 may have a greater length thanface212. The implant also may have arcuate first and secondlongitudinal surfaces202,203, respectively, and aninferior face216 and asuperior face214. One or more vertical windows/channels224 may extend through theimplant200 from theinferior face216 to thesuperior face214. Additionalvertical channels230, extending from theinferior face216 to thesuperior face214 may be positioned on the perimeter of the superior andinferior faces214,216. In some embodiments, theimplant200 may also have one or morehorizontal channels226. The height of thefirst face210 may be greater than the height of thesecond face212.
• Theimplant200 further may have a retention feature comprising afirst fixation member205 projecting from thesuperior surface214 and asecond fixation member215 projecting from theinferior surface216. The first andsecond fixation members205,215 resemble a “keel” such that the keel is oriented fromface210 to face212. The length of the keel may be, and preferably is, greater than the width of the keel, and whose length preferably is 80 to 95 percent of the length of the superior andinferior faces214,216. The first andsecond fixation members205,215 may haveprojections206, such as in the form of a saw-tooth, for engaging the adjacent vertebrae and aiding in securing theimplant200 in the disc space, preferably without the need for supplemental fixation means. No additional plate or screws may be necessary to retain the implant between two vertebrae.Implant200 may be formed of PEEK, titanium, titanium alloy, stainless steel, allograft bone, or any other suitable, biocompatible material, or any combination thereof.
• Theintervertebral implant300, shown inFIG. 18, has arcuate end faces310,312, respectively. Superior and inferior faces,314,316, respectively, which may be curved and may have projections or teeth318 for engaging the adjacent vertebrae and aiding in securing theimplant300 in the disc space. The projections318 may be pyramidal in shape. The implant also haslongitudinal sides302,303. Theintervertebral implant300 of this embodiment differs from theimplant100 in thatintervertebral implant300 has no horizontal or vertical channels, such that superior andinferior faces314,316 andlongitudinal surfaces302,303 has no openings.
• Theimplant300 further has a retention feature comprising afirst fixation member305 projecting from thesuperior face314 and asecond fixation member315 projecting from theinferior face316. The first andsecond fixation members305,315 resemble a “keel” such that the keel is oriented fromfront face310 to endface312. The length of the keel may be, and preferably is, greater than the width of the keel, and whose length is 80 to 95 percent of the width of the superior andinferior faces314,316. The first andsecond fixation members305,315 have a height greater than the height of the projections or teeth318. The first andsecond fixation members305,315 may haveprojections306, such as in the form of a saw-tooth, for engaging the adjacent vertebrae and aiding in securing theimplant300 in the disc space, preferably without the need for supplemental fixation means. No additional plate or screws may be necessary to retain the implant between two vertebrae.Implant300 may be formed of PEEK, titanium, titanium alloy, stainless steel, allograft bone, or any other suitable, biocompatible material, or any combination thereof.
• FIG. 19 depicts yet another embodiment of animplant400 having first and second fixation members405,415 that resemble a “keel” such that the keel is oriented fromfront face410 to endface412. The first and second fixation members405,415 may have generallyparallel side walls416,417 from the front towards the rear or end of the fixation members405,415. Theside walls416,417 of the first and second fixation members405,415 near the end of the keel may be angled towards each other forming awedge418 at the end of the members405,415. Thewedge418 may allow for easier insertion between twovertebrae50. The length of the keel may be, and preferably is, greater than the width of the keel, and whose length is 80 to 95 percent of the width of the superior andinferior faces414,416. The first and second fixation members405,415 have a height greater than the height of the projections orteeth418. The first and second fixation members405,415 may include arecess422. Therecess422 may be sized to fit an insertion tool (not shown), such that thefront420 of the first and second fixation member405,415 have an opening allowing the insertion tool to grip theimplant400 for insertion between two vertebrae.Implant400 may be formed of PEEK, titanium, titanium alloy, stainless steel, allograft bone, or any other suitable, biocompatible material, or any combination thereof.
• The implants described herein are generally sized and configured for anterior insertion, although different configurations may be possible for posterior approaches. In addition to the features shown the implants, spacers, and plate/spacer constructs may have threaded holes, slots or channels to mate with instruments to facilitate holding and inserting the implants.
• Although the present invention and its advantages have been described in detail, it should be understood that various changes, substitutions, and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means, methods and steps described in the specification. As one of ordinary skill in the art will readily appreciate from the disclosure of the present invention, processes, machines, manufacture, composition of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present invention.
• It will be appreciated by those skilled in the art that various modifications and alterations of the invention can be made without departing from the broad scope of the appended claims. Some of these have been discussed above and others will be apparent to those skilled in the art. For example, the present invention may be employed in different sections of the spinal column, including, but not limited to, the cervical area.

Claims (24)

1-25. (canceled)

26. An intervertebral implant comprising:

a spacer having a first insertion end portion, a second end portion opposite the first insertion end portion, a first lateral side portion, a second lateral side portion, an upper surface, and a lower surface, the spacer configured and dimensioned for insertion between vertebrae;

a plate secured to the second end portion of the spacer, the plate including at least two through holes defining first and second central hole axes, the at least two through holes configured and dimensioned to receive bone screws for securing the implant to adjacent vertebrae, the first through hole exits through the upper surface of the spacer, the second through hole exits through the lower surface of the spacer, the first and second central hole axes form non-zero angles with respect to the upper and lower surfaces of the spacer; and

at least one keel formed on at least one of the upper and lower surfaces of the spacer wherein the at least one keel extends from the first insertion end portion of the spacer towards the second end portion of the spacer at least about 50 percent of a distance from the first insertion end portion to the second end portion.

27. The implant according toclaim 26, wherein the keel extends at least about 80 percent of the distance from the first insertion end portion to the second end portion.

28. The intervertebral implant ofclaim 27, wherein the keel extends at least about 95 percent of the distance from the first insertion end portion to the second end portion.

29. The intervertebral implant ofclaim 26, wherein the keel includes a first insertion end and a second end, the first insertion end is wedge shaped.

30. The intervertebral implant ofclaim 26, wherein the keel includes a plurality of projections formed on a top surface thereof, the projections having a saw-tooth shape.

31. The intervertebral implant ofclaim 26, wherein the keel includes a first insertion end and a second end portion, the first insertion end of the keel being substantially aligned with the first insertion end portion of the spacer.

32. The intervertebral implant ofclaim 26, wherein the keel includes a first insertion end and a second end portion, the keel is tapered so that the keel is higher at the second end portion relative to the first insertion end.

33. The implant ofclaim 26, wherein the plate is formed of a different material than the spacer.

34. The implant ofclaim 33, wherein the plate is formed of a metallic material and the spacer is formed of a non-metallic material.

35. The implant ofclaim 34, wherein the plate does not extend beyond a perimeter of the spacer.

36. The implant ofclaim 35, wherein a height of the plate is no more than a height of the spacer at the second end portion so that the plate does not increase a height profile of the spacer.

37. The implant ofclaim 34, wherein the plate includes an outer surface, the through holes formed in the plate being configured such that the first and second central hole axes are generally aligned along a straight line at the outer surface of the plate, the straight line generally corresponding with a mid-plane of the implant.

38. The implant ofclaim 34, wherein the spacer and the plate are secured together by at least one dovetail connection.

39. The implant ofclaim 38, wherein the dovetail connection extends from the upper surface to the lower surface.

40. The implant ofclaim 33, wherein the keel is formed only on the spacer.

41. The implant ofclaim 26, wherein the spacer is solid.

42. The implant ofclaim 26, wherein the spacer includes a plurality of windows.

43. The implant ofclaim 26, wherein the spacer includes a plurality of projections formed on at least one of the upper and lower surfaces, the projections having a height less than a height of the keel.

44. The implant ofclaim 26, wherein the keel has a height of about 1 mm to about 3.5 mm and a width of about 0.5 mm to about 3 mm.

45. An intervertebral implant comprising:

a spacer having a first insertion end portion, a second end portion, an upper surface, and a lower surface, the spacer configured and dimensioned for insertion between vertebrae;

a plate secured to the second end portion of the spacer, the plate including at least one blade configured and dimensioned to penetrate adjacent vertebrae; and

an actuator for causing the at least one blade to move to penetrate adjacent vertebrae.

46. The implant ofclaim 45, wherein the at least one blade is configured to rotate from a first position wherein the blade is adjacent to the plate to a second position wherein the blade is not adjacent to the plate.

47. The implant ofclaim 46, wherein the blades are configured to provide compression as they are rotated into the second position.

48. The implant ofclaim 46, further comprising a locking mechanism to prevent the blades from rotating back to the first position.

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