US20010001129A1 - Osteogenic fusion device - Google Patents

Abstract

An interbody osteogenic fusion device is provided that includes a rigid elongated central element and a pair of opposing bone engaging members. The device promotes fusion bone growth in the space between adjacent vertebrae. In one aspect, a cylindrical end cap is coupled to one end of the central element. The opposing bone engaging members are configured to contact and support the adjacent vertebrae. The opposing bone engaging members are coupled at opposite sides of the central element and extend from the end cap to the other end of the central element. The central element, cylindrical end cap, and bone engaging members define opposite cavities for containing osteogenic material.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• 1. The present application claims the benefit of commonly owned U.S. patent application Ser. No. 08/988,142, filed Dec. 10, 1997, which is hereby incorporated by reference in its entirety.
BACKGROUND OF THE INVENTION
• 2. The present invention relates to an implant to be placed into the intervertebral space left after the removal of a damaged spinal disc. Specifically, the invention concerns an osteogenic fusion device that enhances arthrodesis or fusion between adjacent vertebrae while also maintaining the normal spinal anatomy at the instrumented vertebral level.
• 3. In many cases, low back pain originates from damages or defects in the spinal disc between adjacent vertebrae. The disc can be herniated or can be affected by a variety of degenerative conditions. In many cases, these pathologies affecting the spinal disc can disrupt its normal anatomical function of the disc. In some cases, this disruption is significant enough that surgical intervention is indicated.
• 4. In one such surgical treatment, the affected disc is essentially removed and the adjacent vertebrae are fused together. In this treatment, a discectomy procedure is conducted to remove the disc nucleus while retaining the annulus. Since the disc material has been removed, a body must be placed within the intervertebral space to prevent the space from collapsing.
• 5. In early spinal fusion techniques, bone material, or bone osteogenic fusion devices, were simply disposed between adjacent vertebrae, typically at the posterior aspect of the vertebrae. In the early history of these osteogenic fusion devices, the osteogenic fusion devices were formed of cortical-cancellous bone which was not strong enough to support the weight of the spinal column at the instrumented level. Consequently, the spine was stabilized by way of a plate or a rod spanning the affected vertebrae. With this technique, once fusion occurred across and incorporating the bone osteogenic fusion device, the hardware used to maintain the stability of the spine became superfluous.
• 6. Following the successes of the early fusion techniques, focus was directed to modifying the device placed within the intervertebral space. Attention was then turned to implants, or interbody fusion devices, that could be interposed between the adjacent vertebrae, maintain the stability of the disc interspace, and still permit fusion or arthrodesis. These interbody fusion devices have taken many forms For example, one prevalent form is a cylindrical hollow implant or “cage”. The outer wall of the cage creates an interior space within the cylindrical implant that is filled with bone chips, for example, or other bone growth-inducing material. Implants of this type are represented by the patents to Bagby, U.S. Pat. No. 4,501,269; Brantigan, U.S. Pat. No. 4,878,915; Ray, U.S. Pat. No. 4,961,740; and Michelson, U.S. Pat. No. 5,015,247. In some cases, the cylindrical implants included a threaded exterior to permit threaded insertion into a tapped bore formed in the adjacent vertebrae. Alternatively, some fusion implants have been designed to be impacted into the intradiscal space.
• 7. Experience over the last several years with these interbody fusion devices has demonstrated the efficacy of these implants in yielding a solid fusion. Variations in the design of the implants have accounted for improvements in stabilizing the motion segment while fusion occurs. Nevertheless, some of the interbody fusion devices still have difficulty in achieving a complete fusion, at least without the aid of some additional stabilizing device, such as a rod or plate. Moreover, some of the devices are not structurally strong enough to support the heavy loads and bending moments applied at certain levels of the spine, namely those in the lumbar spine.
• 8. Even with devices that do not have these difficulties, other less desirable characteristics exist. Recent studies have suggested that the interbody fusion implant devices, or cages as they are frequently called, lead to stress-shielding of the bone within the cage. It is well known that bone growth is enhanced by stressing or loading the bone material. The stress-shielding phenomenon relieves some or all of the load applied to the material to be fused, which can greatly increase the time for complete bone growth, or disturb the quality and density of the ultimately formed fusion mass. In some instances, stress-shielding can cause the bone chips or fusion mass contained within the fusion cage to resorb or evolve into fibrous tissue rather than into a bony fusion mass.
• 9. A further difficulty encountered with many fusion implants is that the material of the implant is not radiolucent. Most fusion cages are formed of metal, such as stainless steel, titanium or porous tantalum. The metal of the cage shows up prominently in any radiograph (x-ray) or CT scan. Since most fusion devices completely surround and contain the bone graft material housed within the cage, the developing fusion mass within the metal cage between the adjacent vertebrae cannot be seen under traditional radiographic visualizing techniques and only with the presence of image scatter with CT scans. Thus, the spinal surgeon does not have a means to determine the progress of the fusion, and in some cases cannot ascertain whether the fusion was complete and successful.
• 10. The field of spinal fusion can be benefited by an intervertebral fusion device that can support bone growth material within the intervertebral space, while still maintaining the normal height of the disc space. The device would beneficially eliminate the risk of stress-shielding the fusion mass, and would also provide for visualization of the fusion mass as the arthrodesis progresses.
SUMMARY OF INVENTION
• 11. To address the current needs with respect to interbody fusion devices, the present invention contemplates a osteogenic fusion device that is configured to place as much of the bone growth inducing material as possible into direct contact with the adjacent bone. In one embodiment, the osteogenic fusion device includes an elongated body having opposite first and second end pieces separated by an integral central element. The central element has a significantly smaller diameter than the two end pieces. The osteogenic fusion device thus forms an annular pocket between the end pieces and around the central element.
• 12. In accordance with one aspect of the present invention, a bone growth inducing material is disposed within the annular pocket around the central element of the osteogenic fusion device. In one specific embodiment, the bone growth inducing material can constitute a sheet of a pharmaceutically suitable carrier for a bone growth factor, such as a bone morphogenetic protein. In this embodiment, the sheet can be a collagen sheet that is soaked with the BMP and then subsequently wrapped in spiral fashion around the central element of the osteogenic fusion device.
• 13. In one feature of the present invention, the osteogenic fusion device can be implanted in a bi-lateral approach. Specifically, two such osteogenic fusion devices can be inserted into prepared bores formed in the endplates of adjacent vertebrae after completion of a discectomy. The spinal loads are borne by the two end pieces that are in direct contact with the adjacent vertebral bodies. Preferably, the osteogenic fusion device has a length sufficient to allow the end pieces to at least partially contact the harder bone at the apophysis of the adjacent vertebrae. With the osteogenic fusion device thus inserted, the bone growth inducing material is in direct contact with the adjacent vertebral bodies. In addition, bone growth inducing material can be placed within the bi-lateral space separating the two osteogenic fusion devices. When fusion occurs, a substantial fusion mass is produced that is virtually uninterrupted by the material of the osteogenic fusion device itself.
• 14. Several alternative embodiments of the osteogenic fusion device are presented, all retaining the capability of supporting bone growth inducing material so that it is in direct contact with the adjacent vertebrae. In some embodiments, additional elements of the central element are provided, while in another embodiment, an intermediate piece is provided for further support across the disc space.
• 15. The present invention also contemplates an insertion tool and certain modifications to the osteogenic fusion device to accommodate the tool. In one preferred embodiment, the tool is essentially an elongated shank having opposite prongs extending therefrom. The prongs can engage truncated side walls of one of the end pieces. In addition, the opposite end piece can be formed with notches to receive the tips of the two prongs. With this design, the osteogenic fusion device can be a push-in or a threaded type osteogenic fusion device. In still a further aspect, the insertion devices may include enlarged prongs having external surface corresponding to diameter of the implant. Threaded insertion of the implant may be more easily achieved with this type of insertion tool. Still further, the enlarged prongs may be configured to substantially correspond to the lateral cavities of the implant.
• 16. It is one object of the present invention to provide an interbody fusion device that allows the greatest possible contact between the adjacent vertebrae and the bone growth inducing material supported by the osteogenic fusion device. It is a further object to provide such a osteogenic fusion device that is capable of supporting the loads generated throughout the spine without stress-shielding developing bone within the osteogenic fusion device.
• 17. Another object of the invention is achieved by features that minimize the radio-opacity of the device. This results in a benefit to the surgeon of being able to more readily assess the progress of a spinal fusion.
• 18. In one aspect of the invention, an interbody fusion device is provided that has an upper bone engaging shell, a lower bone engaging shell and a central support maintaining the spacing between the shells. In a preferred aspect, the central support has a width less than half the width of the bone engaging shells. Preferably, lateral cavities are formed by the juncture of the upper and lower shells with the central support. Still further, it is preferred that the upper and lower shells are spaced from each other such that the lateral cavities each have a lateral opening. In still a further preferred aspect, the upper and lower shells extend along substantially the entire length of the central support.
• 19. Other objects and benefits of the present invention can be discerned from the following written description and accompanying figures.
DESCRIPTION OF THE FIGURES
• 20.FIG. 1 is a top elevational view of a osteogenic fusion device in accordance with one embodiment of the present invention.
• 21.FIG. 2 is an end elevational view of one end of the osteogenic fusion device shown in FIG. 1.
• 22.FIG. 3 is a top elevational view of an alternative embodiment of the osteogenic fusion device utilizing exterior threads.
• 23.FIG. 4 is a top cross-sectional view of a osteogenic fusion device as shown in FIG. 1 with a bone growth inducing material supported by the osteogenic fusion device.
• 24.FIG. 5 is an cross-sectional view of the osteogenic fusion device and bone growth material shown in FIG. 4 taken alongline5—5 as viewed in the direction of the arrows.
• 25.FIG. 6 is a plan view of a sheet for a bone growth inducing material used with the osteogenic fusion device shown in FIG. 4.
• 26.FIG. 7 is an end elevational view of one end of a osteogenic fusion device, such as the osteogenic fusion device of FIG. 1, modified to include apertures.
• 27.FIG. 8 is an end elevational view of one end of a osteogenic fusion device, such as the osteogenic fusion device of FIG. 1, modified to include apertures.
• 28.FIG. 9 is a side, partially cross-sectional view of an intervertebral disc space with a osteogenic fusion device according to FIG. 1 implanted between adjacent vertebrae.
• 29.FIG. 10 is a top elevational view of the superior aspect of the instrumented vertebral level shown in FIG. 9, depicting bilateral placement of osteogenic fusion devices according to the present invention.
• 30.FIG. 11 is a cross-sectional view of the instrumented vertebral segment shown in FIG. 10, taken alongline10—10 as viewed in the direction of the arrows.
• 31.FIG. 12 is a top elevational view of a osteogenic fusion device, such as shown in FIG. 1, with features to permit insertion of the osteogenic fusion device.
• 32.FIG. 13 is an end elevational view of the osteogenic fusion device shown in FIG. 12.
• 33.FIG. 14 is a side elevational view of an insertion tool according to one embodiment of the present invention.
• 34.FIG. 15 is a top elevational view of the insertion tool shown in FIG. 14.
• 35.FIG. 16 is a top elevational view of a osteogenic fusion device for restoring the lordotic angle between adjacent vertebrae according to a further embodiment of the present invention.
• 36.FIG. 17 is a top elevational view of a osteogenic fusion device according to a further embodiment of the present invention.
• 37.FIG. 18 is a top elevational view of a osteogenic fusion device according a still further embodiment of the present invention.
• 38.FIG. 19 is an end elevational view of the osteogenic fusion device shown in FIG. 18.
• 39.FIG. 20 is a top elevational view of a osteogenic fusion device according to another embodiment of the present invention.
• 40.FIG. 21 is an end elevational view of the osteogenic fusion device shown in FIG. 20
• 41.FIG. 22 is a top elevational view of a osteogenic fusion device according to yet another embodiment of the present invention.
• 42.FIG. 23 is an end elevational view of the osteogenic fusion device shown in FIG. 22.
• 43.FIG. 24 is a top elevational view of a osteogenic fusion device according to a further embodiment of the present invention.
• 44.FIG. 25 is an end elevational view of the osteogenic fusion device shown in FIG. 24.
• 45.FIG. 26 is a top elevational view of a pair of fusion devices according to FIGS. 24-25 disposed in a bilateral configuration in the lumbar spine.
• 46.FIG. 27 is a top elevational view of a fusion device according to FIGS. 24-25 disposed in the cervical spine.
• 47.FIG. 28 is a side elevational view of an osteogenic fusion device according to yet another embodiment of the present invention.
• 48.FIG. 29 is an end elevational view of the osteogenic fusion device of FIG. 28.
• 49.FIG. 30 is a side elevational view of an osteogenic fusion device according to another embodiment of the present invention.
• 50.FIG. 31 is an end elevational view of the osteogenic fusion device shown in FIG. 30.
• 51.FIG. 32 is a side elevational view of an osteogenic fusion device according to still another embodiment of the present invention.
• 52.FIG. 33 is an end view of an instrumented vertebral level, vertebrae shown in cross-section, depicting bilateral placement of osteogenic fusion devices according to the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
• 53. For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates.
• 54. The present invention contemplates osteogenic fusion devices for use as interbody fusion devices. The osteogenic fusion devices include opposite end pieces that are configured to span the intervertebral disc space and engage the adjacent vertebral bodies. The inventive osteogenic fusion devices include a central element separating the two end pieces and substantially spanning the anterior-posterior length of the disc space. The invention further contemplates that a bone growth-inducing material be disposed about the central element and between the opposite end pieces. When the inventive osteogenic fusion device is implanted within a patient, the bone growth-inducing material is in direct contact with the adjacent vertebral bodies. The end pieces are formed of a material sufficient to withstand the spinal loads generated at the instrumented vertebral level.
• 55. In accordance with one embodiment of the invention, anosteogenic fusion device10, depicted in FIGS. 1-2, includes afirst end piece11 and asecond end piece12. The end pieces are separated by acentral element13. Thefirst end piece11 could be substantially cylindrical or any geometrical shape and includes an outerbone contacting surface15. Theend piece11 also defines an inwardly facing retainingsurface17. Thecentral element13 integrally extends from the retainingsurface17 of thefirst end piece11.
• 56. Thesecond end piece12 also defines abone contacting surface20 that, in this embodiment, does not extend entirely around the end piece. Thebone contacting surface20 could be any geometrical shape, preferably circular and is defined at a radius equal to the radius of theouter surface15 of the first end piece. Thus, as depicted in FIG. 2, thebone contacting surface20 of thesecond end piece12 is generally coincident with portions of theouter surface15 of thefirst end piece11 when the osteogenic fusion device is viewed along the longitudinal axis of itscentral element13. Thesecond end piece12 also includes oppositetruncated surfaces21 that are disposed between the circular bone contacting surfaces20. Preferably, thetruncated surfaces21 are generally flat and can be configured to be engaged by an insertion tool. The insertion tool preferably has arms that contact the flattruncated surfaces21, yet still fall within the envelope defined by theouter surface15 of thefirst end piece11.
• 57. Thesecond end piece12 also defines asecond retaining surface22 that faces the first retainingsurface17 of thefirst end piece11. Again, thecentral element13 is preferably integral with and projects outwardly from thesecond retaining surface22. Alternatively, the central element can be in the form of a central rod that is engaged within colinear bores formed in the two end pieces. In this variation, the engagement between the central rod and the end pieces can be threaded.
• 58. Thecentral element13 includes an outercentral surface23. Preferably, thecentral element13 is substantially cylindrical along its length. In one aspect of the invention, thefirst end piece11 defines a diameter D₁, while thecentral element13 defines a diameter D₂. The diameter D₁is at least equal to the height of the intervertebral space within which theosteogenic fusion device10 is to be interposed. Most preferably, the diameter D₁corresponds to the diameter of a cylindrical channel cut into the endplates of the adjacent vertebrae. In this instance, the diameter D₁will be somewhat larger than the intervertebral disc space height. Moreover, the diameter D₁is significantly larger than the diameter D₂of thecentral element13. This diameter differential creates anannular pocket24 surrounding thecentral element13.
• 59. Theosteogenic fusion device10 has a length L₁between the opposite ends of the osteogenic fusion device. This length L₁is preferably selected to be slightly less than the anterior-posterior length of the intervertebral disc space, although the length can be calibrated to the lateral dimension of the space. Most preferably, the length L₁is sized so that the first andsecond end pieces11,12 can contact at least a portion of the apophysis or harder cortical bone at the perimeter of the vertebral endplates. Theosteogenic fusion device10 further defines a length L₂which is essentially the length of thecentral element13. The length L₂is calibrated so that theend pieces11 and12 are sufficiently wide to provide adequate support between the adjacent vertebrae. Conversely, the length L₂is sufficiently long so that theannular pocket24 has the capacity for retaining a substantial quantity of bone growth-inducing material.
• 60. In a modification of theosteogenic fusion device10, the second end piece can be configured with threads. For example, as depicted in FIG. 3 anend piece25 includes externalbone engaging threads26 extending from theouter surface27. In accordance with this embodiment, thesecond end piece25 can be cylindrical, like thefirst end piece11, or the threads can be formed between truncated surfaces, such astruncated surfaces21 in the prior embodiment. At any rate, the threadedend piece25 is configured to be threadedly advanced into a drilled and tapped channel within the adjacent vertebral bodies. Thefirst end piece11 can also be threaded to facilitate insertion and to reduce the chance of expulsion.
• 61. In a further aspect of the invention, a bonegrowth inducing material30 is provided for support by theosteogenic fusion device10. Preferably thematerial30 is in the form of a sheet. In a specific example, thecarrier sheet30 can be a collagen sheet that is soaked with a solution containing a bone growth inducing substance, or a bone morphogenetic protein (BMP). In accordance with the invention, thecarrier sheet30 can be formed of a variety of materials other than collagen, provided the materials are capable of containing a therapeutically effective quantity of a bone growth inducing substance or BMP. Moreover, thematerial30, whether in sheet form or not, is most preferably susceptible to manipulation to be disposed within theannular pocket24 of thefusion device10.
• 62. In accordance with the specific embodiment, thecarrier sheet30 is wound around theouter surface23 of the central element13 (see FIG. 5). Thecarrier sheet30 is held between the retainingsurface17 of thefirst end piece11 and the retainingsurface22 of thesecond end piece12. In accordance with one specific embodiment, the retainingsurface22 is curved or convex. In this way, thecarrier sheet30 can project into the convexity to serve as a sort of anchor to hold thecarrier sheet30 within theannular pocket24 of theosteogenic fusion device10. In addition, theconvex surface22 conforms better with the anterior portion of the vertebral body profile when the fusion device is implanted.
• 63. In the illustrated embodiment, thecarrier sheet30 can be provided as a single sheet, as shown in FIG. 6. Theinner end31 of the sheet is disposed against the centralouter surface23 of thecentral element13. The sheet can be wound in a spiral fashion about thecentral element13 until itsouter end32 is disposed adjacent theouter surface15 of thefirst end piece11. Thecarrier sheet30 has width W that is preferably slightly larger than the length L₂between the first and second end pieces to allow a portion of thecarrier sheet30 to project into theconcave retaining surface22 of thesecond end piece12. The overall length of thesheet30 between ends31 and32 depends upon its thickness and the difference in diameters D₁and D₂. For example, in one embodiment the diameter D₂is about one-fourth (¼) the diameter D₁. Preferably, the length is sufficient so that thecarrier sheet30 can be tightly wound about thecentral element13 and fill theannular pocket24. One important object of the present invention is that thecarrier sheet30 or bone growth inducing material reside in direct contact with the adjacent vertebral bone. Consequently, thesheet30 is preferably wound so that itsouter end32 is at least slightly outside the envelope of theouter surface15 of thefirst end piece11.
• 64. Thecarrier sheet30 of FIGS. 4-6 illustrates one specific embodiment of bone growth-inducing material usable with the osteogenic fusion device of the present invention. It is also contemplated that the carrier can be in the form of a sponge, paste, gel or a settable osteogenic material. The osteogenic material must be provided in some form that can be generally retained about thecentral element13 and within theannular pocket24 of theosteogenic fusion device10. Put differently, the present invention contemplates an osteogenic material that does not need to be contained in the traditional manner of the hollow cylindrical cages of the prior art. In these prior art devices, cancellous bone chips have been contained within a hollow cage. The present invention does not contemplate the use of bone chips alone. However, bone chips contained within a bone paste or a gel may be utilized with theosteogenic fusion device10, provided that the paste or gel have a consistency sufficient to hold the bone growth inducing material on and within theosteogenic fusion device10.
• 65. In accordance with one specific embodiment, theend pieces11 and12 are solid and circular in configuration. Alternative end piece configurations are shown in FIGS. 7 and 8. For example,end piece11′ can have a plurality of generallycircular apertures34 disposed circumferentially about the end piece, as shown in FIG. 7. Theend piece11″ shown in FIG. 8 includes a plurality of pie-shapedapertures35 so that the end piece gives the appearance of a spoked wheel. Thesecond end piece12 of theosteogenic fusion device10 can have similar apertures defined therethrough. Theapertures34 and35 in theend pieces11′,11″ provide a further avenue for facilitating fusion bone growth. The apertures themselves can be filled with a osteogenic material, such as a gel or a paste. Moreover, once theosteogenic fusion device10 is implanted within an intervertebral disc space, osteogenic material can be packed around the osteogenic fusion device within the disc space. These additional apertures in theend pieces11,12 provide further avenues for the formation of a bony bridge between adjacent vertebrae.
• 66. Theend pieces11,12, etc. can also have non-circular shapes. For instance, the end pieces can be rectangular or other multi-sided shapes. If the osteogenic fusion device resides within a channel prepared in the endplates, the channel shape can be modified to conform to thebone engaging surfaces15,20 of the end pieces.
• 67.FIGS. 9-11 depict a pair ofosteogenic fusion devices10 implanted in a bi-lateral configuration between adjacent vertebral bodies V₁and V₂. As depicted, the disc annulus A is retained but at least one portal must be defined in the annulus A to permit insertion of theosteogenic fusion devices10. The present invention also contemplates insertion of eachosteogenic fusion device10 through its own portal formed in the disc annulus A. Alternatively, in conformance with other known procedures, a single portal can be provided through which eachosteogenic fusion device10 is successively inserted. Further in accordance with the present invention, theosteogenic fusion devices10 can be positioned within the intervertebral disc space according to known posterior or postero-lateral techniques.
• 68. According to the present invention, theosteogenic fusion device10 is inserted into the disc space S with thefirst end piece11 proceeding first into the space Preferably, a channel C is bored into the vertebral endplates E to a preferred depth of insertion of theosteogenic fusion device10, in accordance with known techniques. If the osteogenic fusion device to be implanted is of the type shown in FIG. 3 with the threadedsecond end piece25, the channels C can be appropriately drilled and tapped to accommodate thebone engaging threads26. In a modification of this embodiment, thefirst end piece11 can also carry external threads.
• 69. The preferred embodiment contemplates a generally cylindrical osteogenic fusion device placed within circular channels. Alternatively, the osteogenic fusion devices can operate as spacers that directly contact the endplates, without a prepared channel. In this instance, the bone engaging surfaces of the end pieces can be modified to conform to the vertebral endplate geometry.
• 70. As depicted in FIGS. 9-11, theosteogenic material30 is disposed in direct contact with the adjacent vertebral endplates E. Moreover, the placement ofosteogenic fusion devices10 can present amedial space37 between the two osteogenic fusion devices. Osteogenic material can then be placed within themedial space37, again in direct contact with theosteogenic material30 situated around thecentral elements13 of each of theosteogenic fusion devices10. Once complete fusion occurs, new bone growth will substitute thecarrier material30 to form a solid bony bridge spanning the adjacent vertebrae V₁, V₂. As can be seen from FIGS. 9-11, the region of continuous bone growth is very substantial and is not interrupted by the structure of the fusion device itself.
• 71. It is understood, of course, that theend pieces11 and12 provide sufficient support for the vertebral loads passing between the adjacent vertebrae. At the same time, this load bearing capacity is concentrated outside the middle regions of the vertebral endplates E. It is known that the central region of the endplates is very rich in blood flow and has a high capacity for new bone growth. Thus, the elimination of structural material of theosteogenic fusion device10 from that region provides for a faster and more complete arthrodesis than may have been possible with prior fusion cages.
• 72. Referring next to FIGS. 14, 15, aninsertion tool50 is depicted for inserting aosteogenic fusion device10 according to the present invention. Theinsertion tool50 includes asolid shank51 to which a knob or handle52 is affixed. Theknob52 is configured fox manual grasping and manipulation during insertion of the osteogenic fusion device. In the case where the osteogenic fusion device is not threaded, theinsertion tool50 simply acts as a pushing device. On the other hand, in the instance where the osteogenic fusion device includes threaded end pieces such as shown in FIG. 3, theinsertion tool50 must be rotated as the end piece is threaded into the prepared channel between the adjacent endplates.
• 73. Theinsertion tool50 includes a pair ofprongs53 that are disposed apart to define an end piece recess54. For insertion of theosteogenic fusion device10 shown in FIG. 1, the end piece recess54 is configured so that theprongs53 are in tight contact with thetruncated surfaces21 of thesecond end piece12. The outer surface of theprongs53 can conform to a portion of theouter surface15 of thefirst end piece11.
• 74. Theinsertion tool50 depicted in FIGS. 14-15 also includes taperedtips55 at the ends of each of theprongs53. These tapered tips are configured to be received within drivingnotches41 in a modifiedfirst end piece40, as depicted in FIGS. 12-13. The osteogenic fusion device depicted in FIGS. 12-13 is substantially similar to theosteogenic fusion device10 shown in FIG. 1, with the exception of the added driving notches. Theinsertion tool50 is configured so that thetips55 project into thenotches41 while theprongs53 directly contact thetruncated surfaces21 of thesecond end piece12. This particular configuration of the insertion tool is particularly useful for threaded insertion of the osteogenic fusion device. Preferably, theprongs53 have an effective outer diameter that is approximately equal to the diameter D₁. Moreover, theprongs53 can have an arc segment configuration to complement the truncated surfaces21. If theend piece12 is threaded (see FIG. 3), theprongs53 can include complementary threads along their length.
• 75. The present invention also contemplates a osteogenic fusion device for restoring the normal lordotic angle of an intervertebral segment. Specifically, a lordoticosteogenic fusion device60 includes a first end piece61 and asecond end piece62 as shown in FIG. 16. As with the prior embodiments, acentral element63 is provided to connect the two end pieces. Theouter surface65 of the first end piece61 is in the form of a frusto-conical surface. Theouter surface65 tapers toward thesecond end piece62 at a preferred lordotic angle. Similarly, theouter surface66 of thesecond end piece62 is also tapered at a similar lordotic angle. Alternatively, thesecond end piece62 can include threads formed on theouter surface66. While thethreads66 at the smallersecond end piece62 may not contact the vertebral endplates at the larger insertion end, the threads will contact the endplates at the anterior end of the intradiscal space and will act as an anchor to resist expulsion of the lordoticosteogenic fusion device60.
• 76. The present invention contemplates several modifications to the basicosteogenic fusion device10. For example, theosteogenic fusion device70 shown in FIG. 17 includes first andsecond end pieces71,72 and acenter piece73 disposed between the two end pieces. First and secondcentral elements74 and75 connect each of theend pieces71,72 to thecenter piece73. In this instance, thecenter piece73 will contact the interior of the disc endplates E. Osteogenic material, such ascarrier sheets30, can be disposed or wound around each of thecentral elements74,75 until the end of the bone growth inducing material is exposed at the outer surface of theosteogenic fusion device70.
• 77. In a further modification, aosteogenic fusion device80 depicted in FIG. 18 includes first andsecond end pieces81 and82 that are connected by a plurality ofcentral beams83. In the illustrated embodiment as shown in FIG. 19, foursuch beams83 are provided; however, other arrangements and numbers of beams are contemplated. Important aspects of the present invention are retained by theosteogenic fusion device80 because osteogenic material can be supported by theseveral beams83 between the first andsecond end pieces81,82, with the bone growth inducing material in direct contact with the adjacent vertebral bodies.
• 78. The two embodiments of FIGS. 20-21 and FIGS. 22-23 pose a slight deviation from the general concept of theosteogenic fusion device10. In these two embodiments, the smaller diametercentral element13 is replaced by a wall. In the embodiment of FIGS. 20-21, aosteogenic fusion device85 includes first and second ends86,87 separated by acentral element88. The first and second ends86 and87 can be in the form of short cylindrical sections, such as thefirst end piece11 of theosteogenic fusion device10 in FIG. 1. While thecentral element88 can be in the form of a solid wall, theosteogenic fusion device85 preferably includes a number ofslots89 defined through thecentral element88. In accordance with the specific embodiment, the slots extend along substantially the entire length of thecentral element88. While theosteogenic fusion device85 deviates somewhat from the concept of theosteogenic fusion device10, this latterosteogenic fusion device85 retains the broad beneficial feature of the present invention, namely provision for direct contact between osteogenic material supported by theosteogenic fusion device85 and the vertebral endplates. In the present instance, the osteogenic material can be situated on opposite sides of thecentral element88. In addition, the material can be passed through theslots89.
• 79. Preferably, theosteogenic fusion device85 will be oriented within the intervertebral disc space with thecentral element88, or wall, spanning between the adjacent vertebrae. Thiscentral element88, then, will provide additional structure and load bearing capability for sustaining the spinal loads at the instrumented level.
• 80. Theosteogenic fusion device90 of FIGS. 22-23 operates on a similar concept to theosteogenic fusion device85. However, in this instance, the first and second end pieces are in the form of arc segments, rather than shortened cylinders. The arc segments and central wall provide the implant with an I-beam appearance as best seen in FIG. 23. Specifically, theosteogenic fusion device90 includes upper and lower first arc segments91_Uand91_L, and upper and lower second arc segments92_Uand92_L. Theosteogenic fusion device90 also includes acentral element93 that is again in the form of a wall connecting the first and second end pieces. As can be seen most clearly in FIG. 23, the arc segments91,92 andcentral element93 define a pair ofcavities96 for containing osteogenic material. In this embodiment, the osteogenic material can be contained completely from end to end of theosteogenic fusion device90. In the prior embodiments, the osteogenic material is contained within retaining surfaces of the opposite end pieces. In accordance with a specific embodiment, theosteogenic fusion device90 includes a plurality ofapertures94 defined in each of the upper and lower first and second arc segments91_U,91_L,92_Uand92_L. Similarly, a plurality ofapertures95 can be defined through thecentral element93. In this manner, the apertures provide the maximum capacity for bone ingrowth not only around, but also through theosteogenic fusion device90.
• 81. Aosteogenic fusion device100 shown in FIGS. 24-25 again presents a slightly different concept. Thisosteogenic fusion device100 includes afirst end plate101, asecond end plate102 and acentral element103 that are similar to the like-named components of theosteogenic fusion device10. However, theosteogenic fusion device100 also includes aside piece104 spanning between the first andsecond end pieces101,102. Moreover, unlike theosteogenic fusion device10, the first andsecond end pieces101,102 are not generally circular in configuration, but are generally rectangular in configuration. In one specific embodiment, theend pieces101,102 can include cutouts105 at opposite sides of the end pieces to provide further avenues for the formation of a bony bridge between adjacent vertebrae. As with the prior embodiments, theosteogenic fusion device100 provides means for adequately containing osteogenic material, such as in the form of thecarrier sheet30. In this embodiment, thecarrier sheet30 can be wound around thecentral element103, in the manner described above. This particular embodiment of the invention, namelyosteogenic fusion device100, is preferably adapted for use in the lumbar spine as illustrated in FIG. 26 and in the cervical spine illustrated in FIG. 27, and is consequently sized accordingly.
• 82. A top elevational view of anosteogenic fusion device110 according to a further embodiment is shown in FIG. 28, and an end elevational view of theosteogenic fusion device110 is shown in FIG. 29. This interbody fusion device has many features in common with the embodiments shown in FIGS. 22 and 23. More specifically, the implant is formed to define a substantially I-beam shape similar to the previously disclosed implant. Theosteogenic fusion device110 has a rigid elongatedcentral element112, anend cap114, and a pair of oppositebone engaging members116 and118. Thecentral element112 is preferably rectangular in shape, although other shapes are suitable. The central element has a first end and an opposite second end along the short edge of the rectangle. The long edges of the rectangular central element define opposing upper and lower edges.Central element112 is preferably a wall having a first planar face and an opposing planar face. Still more preferably, the wall is a solid member integrally formed with the bone engaging members. In a preferred aspect, the wall has a thickness between the planar faces that is less than one half the overall width of the implant. Still more preferable, the wall has a width of less than one third of the overall width of the implant.
• 83.Cylindrical end cap114 is coupled to one end of thecentral element112. Thebone engaging members116 and118 are provided on and extend along the upper and lower edges of the central element.Bone engaging members116 and118 extend substantially along the central element from the endadjacent end cap114 to the opposite end of thecentral element112. Thebone engaging members116 and118 are configured to contact and support adjacent vertebrae. In a preferred aspect, bone engaging portions are substantially arcuate segments and athread pattern115 is defined thereon.
• 84. Thecentral element112,bone engaging member116 andbone engaging member118 define a pair ofcavities117 and119 extending along the lateral edges ofimplant110. Thecavities117 and119 are closed on one end bycap114 and are open at the end oppositecap114.Cavity117 is defined bybone engaging member116a,bone engaging member118aand the first planar face of thecentral member112.Bone engaging member116aterminates inend130 andbone engaging member118aterminates inend132. The space between ends130 and132 defines a lateral opening tocavity117. Preferably the lateral opening extends along a substantial length ofcentral member112.
• 85. In a similar manner,cavity119 is defined bybone engaging member116b,bone engaging member118band the second planar face of thecentral member112.Bone engaging member116bterminates inend134 andbone engaging member118bterminates inend136. The space between ends134 and136 defines a lateral opening tocavity119. Preferably the lateral opening extends along a substantial length ofcentral member112.
• 86. Thecavities117 and119 are adapted to receive and contain osteogenic material. In yet another form, the osteogenic fusion device can includeapertures120 and122 to promote bone ingrowth. Theapertures120 extend through thecentral element112 betweencavities117 and119. Theapertures122 are defined through thebone engaging members116 and118 from the exterior of the arcuate surface to the interior of the arcuate surface. Thecentral element112 can further include slots or other larger apertures depending on competing factors of contact between cavities and strength of the central element.
• 87. Still another embodiment of the present invention is shown in FIGS. 30-31. The device illustrated has many features in common with the implant of FIGS. 28 and 29. However, in this embodiment,osteogenic fusion device122 is tapered fromcap114 to the opposite end. Osteogenic material may be filled into thecavities117 and119 once thedevice122 is inserted between the vertebrae.
• 88. The above described implants may be formed of any suitable biocompatible material. In a preferred form, the bone engaging shells, central wall and end cap are integrally formed. It is contemplated that the end cap and/or bone engaging shells may be separate components joined to the implant by any suitable means, including but without limitation, welding, gluing, deformation, threading, pinning, screws, channels, and press fit techniques.
• 89. Devices according the present invention may be inserted into the disc space between adjacent vertebrae by any known techniques. These may include either push-in or threaded insertion. Particularly for threaded insertion, a tool having a pair of movable fingers may be positioned to engage thecentral member112. Preferably, the flexible fingers have extensions that are adapted to extend into and engageapertures126. In combination or as an alternative to such extensions, the insertion tool may be configured to closely match at least a portion of thesurfaces defining cavities117 and119. In this form, the insertion tool may rotate theimplant110 for threaded insertion by driving against the upper and lower shells and central beam in combination. Still more preferably, the insertion tool will have an arcuate outer surface extending betweenends130 and132 to complete the circular shape of the arcuate portions. In a similar manner, a corresponding arcuate outer surface of the insertion tool extends between ends134 and136 to complete the circular shape of the implant. Preferably, the insertion tool diameter matches the root diameter of the implant to ease insertion.
• 90. A further embodiment of an implant according to the present invention is shown in FIG. 32. As with the previously described embodiments, in this embodiment upperbone engaging shell202 and lowerbone engaging shell204 are separated by acentral beam206. The central beam maintains the vertical spacing between the bone engaging shells. The central beam extends substantially perpendicular to the upper and lower bone engaging surfaces to create an overall I-beam appearance. Preferably, and as shown in FIG. 33,bone engaging shells202 and204 are arcuate to correspond to similar openings defined in the vertebrae V₁and V₂. However, it is contemplated thatshells202 and204 may be planar or have other configurations without deviating from the invention.
• 91. Referring to FIG. 33, a pair ofimplants200aand200bare positioned in the space between vertebrae V₁and V₂. Theimplants200aand200bare positioned with the upper bone engaging shells contacting upper vertebra V₁and lower bone engaging shells contacting V₂. The central beam of each implant maintains the vertical spacing of the shells. Once the implants are positioned, the cavities of each implant directed medially form a relatively large open area to receive bone growth inducing material. In a preferred aspect, the bone growth inducing material has sufficient rigidity to interconnectimplant200aand200bto inhibit rotation. Similarly, the cavities of the implant facing the lateral aspect of the disc space may also receive bone growth inducing material.
• 92. The present invention contemplates osteogenic fusion devices that are formed of a material that is sufficiently strong to support the adjacent vertebrae and to maintain the disc height of the instrumented intervertebral space. For example, the osteogenic fusion devices, such asosteogenic fusion device10, can be formed of a biocompatible sterilizable metal, such as stainless steel or titanium. Of course, other medical grade materials are contemplated of either synthetic or natural origin, such as but without limitation to certain ceramics, polymers, carbons, etc., as well as allograft and xenograft bone, provided the materials are sufficiently strong. As a further example, the implant may be formed of a bioresorbable material, such as PLA and related materials, such that over time the implant is resorbed or incorporated into the body. The overall dimensions of each of the osteogenic fusion devices described above depends upon the instrumented level. For example, a osteogenic fusion device for use in the cervical spine must necessarily be smaller than a osteogenic fusion device used in the lumbar spine. Moreover, the relative dimensions of the components of the osteogenic fusion devices may be altered depending upon the vertebral level to be instrumented. For example, a osteogenic fusion device, such asosteogenic fusion device10, for use in the lumbar spine, may require acentral element13 having a diameter D₂that is more than one fourth of the outer diameter D₁of theouter surface15 of thefirst end piece11. In some instances, the lumbar spine may generate bending moments across a osteogenic fusion device, such asosteogenic fusion device10, that would require a strongercentral element13.
• 93. In accordance with the present invention, the illustrated osteogenic fusion devices can be of the push-in or threaded-in type. Of course, the end pieces, such asend pieces11,12 ofosteogenic fusion device10, can include various surface characteristics known in the art for enhancing the degree of fixation of the osteogenic fusion device between the adjacent vertebrae. For example, the end pieces can include certain macro surface features for penetrating the vertebral endplates to resist expulsion of the osteogenic fusion devices. Likewise, the surfaces, such asouter surface15 andbone contacting surface20 can be provided with bone ingrowth coatings so that a certain amount of bone ingrowth occurs even between the end pieces and the adjacent vertebral bodies.
• 94. While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiments have been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.

Claims (24)

What is claimed is:

1. An implant for promoting fusion bone growth in a space between upper and lower adjacent vertebrae, comprising:

a rigid elongated central element having a first end, a second end, and opposite sides;

a pair of opposing bone engaging members configured to contact and support the upper and lower adjacent vertebrae, said opposing bone engaging members being coupled at said opposite sides of said central element; and

wherein said opposing bone engaging members and said central element define opposite cavities for containing osteogenic material.

2. The implant of

claim 1

, wherein said bone engaging members are tapered to conform to the space between the adjacent vertebrae.

3. The implant of

claim 1

, wherein said central element has at least one aperture extending between said opposite cavities.

4. The implant of

claim 1

, wherein said opposing bone engaging members are threaded.

5. The implant of

claim 1

, wherein said opposing bone engaging members have apertures formed therein.

6. The implant of

claim 1

, wherein said central element bisects said opposing bone engaging members.

7. The implant of

claim 1

, wherein said central element and said opposing bone engaging members are integrally formed together.

8. The implant of

claim 1

, wherein said central element has a pair of slots provided therein.

9. The implant of

claim 1

, further comprising the osteogenic material provided in said cavities.

10. The implant of

claim 1

, wherein said central element has a rectangular shape.

11. The implant of

claim 1

, wherein said central element is solid.

12. An implant for promoting fusion between an upper and lower vertebra, comprising:

an upper bone engaging shell for engaging the upper vertebra;

a lower bone engaging shell for engaging the lower vertebra;

a center beam spacing said upper bone engaging shell and said lower bone engaging shell.

13. The implant of

claim 12

, wherein said upper bone engaging shell has a longitudinal axis and said central beam extends substantially along said longitudinal axis.

14. The implant of

claim 12

, wherein said upper shell has a first width, said lower shell has a second width, and said central beam has a third width, said third width less than said first and second widths such that said upper and lower shells over hang said central beam.

15. The implant of

claim 12

, wherein said central beam includes a first end, an opposite second end and a middle portion, said upper and lower shells extending adjacent at least said first end and said opposite end.

16. The implant of

claim 15

, wherein said upper and lower shells extend along said central beam from adjacent said first end to adjacent said second end.

17. The implant of

claim 12

, further including a thread pattern defined on said upper bone engaging shell and said lower bone engaging shell.

18. An implant for promoting fusion between adjacent vertebrae, comprising:

a body having an upper bone engaging surface and a lower bone engaging surface spaced by an intermediate member said body having a longitudinal axis and said intermediate member extending along said longitudinal axis, said upper bone engaging surface and said lower bone engaging surface defining an internal cavity, said cavity interrupted by said intermediate member.

19. The implant of

claim 18

, wherein said upper and lower bone engaging surfaces have a first width and said intermediate member has a second width, said second width less than one half said first width.

20. The implant of

claim 18

, wherein said body is integral.

21. The implant of

claim 8

, wherein said upper bone engaging surface and said lower bone engaging surface are arc segments.

22. The implant of

claim 21

, wherein said arc segments extend along the length of said intermediate member.

23. The implant of

claim 22

, further including a cylindrical end cap positioned on one end of said intermediate member.

24. An interbody spacer for positioning between upper and lower vertebrae, comprising:

a body formed into a substantial I-beam configuration with an upper bone engaging surface adapted for engagement with the upper vertebra and a lower bone engaging surface adapted for engagement with the lower vertebra and a central wall extending between and substantially perpendicular to said bone engaging surfaces.

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