# Patent

## Title
Interbody fusion system with intervertebral implant retention assembly

## Abstract

An implant assembly is disclosed, and includes an implant member and a plate configured to be coupled with the implant member. The plate defines a horizontal plane and includes at least one bore through the plate. The bore has an inlet aperture and at least one exit aperture. The inlet aperture has a curvilinear seat. A fastener is configured for insertion through the at least one bore, and the fastener has a curved portion. The curved portion of the fastener is configured to contact the contact the curvilinear seat to secure the plate to the implant member.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation application claiming the benefit and priority of U.S. patent application Ser. No. 12/710,103, filed on Feb. 22, 2010, which claims benefit of the filing date of U.S. Provisional Patent Application No. 61/154,038, filed on Feb. 20, 2009, and U.S. Provisional Patent Application No. 61/239,230, filed on Sep. 2, 2009, the contents of each of which is herein incorporated by reference in their entirety.


FIELD OF THE INVENTION
The present invention relates generally to an interbody fusion system having an intervertebral retention assembly, and more particularly to intervertebral implants, and intervertebral implant assemblies incorporating a biomechanical implant construct inclusive of stabilizing instrumentation (an anterior, posterior or lateral stabilizer), constructed and arranged to provide superior and inferior vertebral fixation by multiple fixation elements via a single through hole, which through hole can accommodate a fixation element retainer component (hereinafter referred to as a screw retainer component, e.g. a third piece of instrumentation which acts as a retention device to prevent separation of a loosened fixation element from the stabilizing anterior, posterior or lateral instrumentation.
BACKGROUND OF THE INVENTION
Intervertebral spacer implants, either alone or further provided as an assembly, inclusive of a retention mechanism to help alleviate expulsion and movement of the implant when placed in the spine, are well known. Such implant assemblies are advantageous in providing an implant that is easier to insert in the spine, and which resists expulsion subsequent to implantation. Intervertebral spacer implant assemblies which include a spacer and a plate, where the plate comprises a supplemental or alternative retention mechanism having one or more holes in the anterior end of the plate that are directed toward the superior, inferior or both endplates of adjacent vertebrae are also known in the art. Such implants are used to stabilize and immobilize the spinal segments in the treatment of single or multi-level degenerative disc disease, spinal stenosis, and failed previous fusions, as well as other spine conditions.
The problem with many of these implants resides in preservation of the highest degree of mobility possible, while avoiding backing out or loosening of the implant assembly fastening elements, such as bone screws and the like.
As will be illustrated herein, the prior art devices often lack sufficient means to insure lockable engagement of the anterior instrumentation and fastener elements, nor do they provide passive means to enable screw retention. In many instances the screw retainer components are provided as separate elements, which must be installed by the surgeon via a separate and distinct step subsequent to application of the fixation element.
An additional deficiency of the prior art devices is that they are not designed to enable the surgeon to place multiple bone fasteners within a single entry point, so as to provide the surgeon with the freedom to moderate the angularity of the fastener elements in such a manner that they can be targeted for both the superior and inferior vertebral bodies surrounding the implant.
The instant invention satisfies a long felt need in the art by providing a biomechanical implant with stabilizing instrumentation, (which instrumentation will alternatively be referred to as anterior, posterior or lateral instrumentation throughout the present disclosure) which provides stabilization to the adjacent vertebra wherein a single opening in such instrumentation permits bone screws or equivalent fixation elements to be positioned within both the superior and inferior vertebral body surrounding the implant, and wherein said bone screws or equivalent fixation elements are constructed and arranged to cooperate with an elongated and dished curvilinear opening formed within a first surface of the anterior instrumentation, effective to urge the fixation elements into locking engagement, one to the other, as well as with the anterior instrumentation, upon final fixation of the components, thereby forming a frictionally engaged assemblage. A further long felt need is met by the inclusion of a screw retainer component, which is in the form of a passive locking ring or equivalent device, which constitutes a third piece of instrumentation in this device. The screw retainer component resides in a mounting area formed near the first surface of the anterior instrumentation and is constructed and arranged to deflect from a resting position, so as to allow passage of each fastener element, subsequent to which passage, the screw retainer component returns to its initial position so as to block any of the fasteners from separating from the anterior instrumentation, should loosening or breakage occur.
DESCRIPTION OF THE PRIOR ART
U.S. Pat. No. 7,041,135 (Michelson) is directed toward an apparatus including an interbody spinal fusion implant having a leading end, a trailing end, and a length therebetween, and opposed upper and lower portions adapted to contact each of the adjacent vertebral bodies. Each of the upper and lower portions has at least one screw hole passing there through proximate the trailing end. The apparatus further includes bone screws adapted for placement through the screw holes of the upper and lower portions and into each of the adjacent vertebral bodies adjacent the disc space to be fused and into which the implant is adapted to be positioned. Although an embodiment is shown containing a single recess opening having two exit holes, so that two screws are sited in the same aperture, the screws can not impinge upon each other to create a frictional locking engagement with the plate, and therefore, at least one lock is taught to prevent the bone screws from backing out of the vertebral bodies and implant, the necessity of which is eliminated by the instantly disclosed invention.
U.S. Published Patent Application 2005/0071008 (Kirschman) relates to a spinal fusion system and method for use as a prosthetic implant. The system and method includes a housing dimensioned to be situated between adjacent spinal bones, such as adjacent vertebrae. The housing cooperates with the spinal bones to define a graft area for receiving graft material, which may be inserted anteriorly into the housing during a surgical operation such as a vertebrectomy or discectomy. A housing may have various features such as migration preventers to prevent the housing from migrating posteriorly towards a spinal column and can be used with a cover that permits the housing to “float” relative thereto. Screws are provided in one embodiment and are dimensioned or configured to lock against each other to retain the screws and, consequently, the cover in place. The publication fails to teach or suggest a construction wherein a single opening permits a bone screw to be positioned within both the superior and inferior vertebral body surrounding the implant, or wherein two bone screws or the like are positionable through a single hole within a particular vertebral body, and wherein said bone screws or the like are in locking engagement with the intervertebral implant assembly.
U.S. Published Patent Application 2005/0187551 (Orbay et al) is directed toward a bone plating system which includes a plate, fixed angle and variable angle bone screws, and corresponding set screws for each type of the bone screws. The plate includes common openings adapted to receive the variable and fixed angle bone screws, both of which can be locked relative to the plate with the set screws. In all modes of use, a set screw, sometimes in combination with a sliding washer, is then used to fix the level of compression and prevent loosening. In one mode of use, a bone screw can also be driven to cause displacement of the plate such that pressure is applied to maintain bone parts together about a fracture in tight engagement. It is noted that in FIG. 15, screw head 775 locks down on adjacent screw head 161, and that FIG. 3 teaches an oval opening into which the screws are inserted. Again, the publication fails to teach or suggest a construction wherein a single opening permits a bone screw to be positioned within both the superior and inferior vertebral body surrounding the implant, or wherein two bone screws or the like are positionable through a single hole within a particular vertebral body, and wherein said bone screws or the like are in locking engagement with the intervertebral implant assembly.
WO 2007098288 (Messerli et al) shows an implant with anterior plate means to affix the bone spacer by means of screws directed both inferiorly and superiorly of the anterior plate. This device does not include an oval hole receiving two screws but rather has separate screw holes directed upwardly and downwardly. See FIGS. 2, 3 and 5 as exemplary thereof. This publication also fails to teach or suggest a construction wherein a single opening permits a bone screw to be positioned within both the superior and inferior vertebral body surrounding the implant, or wherein two bone screws or the like are positionable through a single hole within a particular vertebral body, and wherein said bone screws or the like are in locking engagement with the intervertebral implant assembly.
U.S. Published Patent Application 2006/0085071 (Lechmann) teaches an intervertebral implant having a three-dimensional body (10) and a securing plate (1). The three-dimensional body (10) includes an upper side (1) and an underside (2) which are suitable for abutting the end plates of two adjacent vertebral bodies, a left side surface (3) and a right side surface (4), a front surface (5) and a rear surface (6), a horizontal middle plane (7) between the upper side (1) and the underside (2), and a vertical middle plane (12) extending from the front surface (5) to the rear surface (6). The three-dimensional body further includes a plurality of boreholes (9a) passing through the body (10), which are suitable for accommodating longitudinal fixation elements (20). The intervertebral implant also includes a front plate (8) displaceably disposed as an insert with the front side (5) of the three-dimensional body, the front plate (8) having a plurality of boreholes (9) in which the longitudinal fixation elements (20) can be anchored, and whose openings overlap with the openings of the boreholes of the three-dimensional body (10). A securing plate can be fastened essentially parallel to the front plate (8) at the three-dimensional body (10) in such a manner that the boreholes of the front plate (9) are covered at least partly by the securing plate (18). By virtue of the configuration of the intervertebral implant, a rigid, firm connection between the intervertebral implant and the longitudinal fixation elements used to fasten it, is possible. This publication likewise fails to teach or suggest a construction wherein a single opening permits a bone screw to be positioned within both the superior and inferior vertebral body surrounding the implant, or wherein two bone screws or the like are positionable through a single hole within a particular vertebral body, and wherein said bone screws or the like are in locking engagement with the intervertebral implant assembly. On the contrary, the reference requires the use of a secondary locking plate in order to prevent backing out or loosening of the bone screws.
U.S. Reissue 28,841 (Allgower et al) and U.S. Published Patent Application 2002/0045901 (Wagner) are exemplary of bone plates having an oval screw opening. They disclose a bone plate which includes an upper surface, a bone contacting surface, and at least one hole extending through the upper and bone contacting surfaces. The bone plate defines a longitudinal axis. The at least one hole defines a central axis and is elongated in a direction substantially aligned with the longitudinal axis. The hole may include a threaded portion and a non-threaded portion, and the threaded portion may extend through an angle of between about 190° and about 280° with respect to the central axis.
U.S. Published Patent Application 2006/0247639 (Anderson) shows dual screw holes connected by a slot, and in one embodiment (FIG. 10) illustrates divergent screw holes.
The prior art fails to provide a construction wherein a single opening permits bone screws to be positioned within both the superior and inferior vertebral body surrounding the implant, or wherein two bone screws or the like are positionable through a single hole within a particular vertebral body, and wherein said bone screws or the like are in locking engagement with the intervertebral implant assembly, upon final fixation thereof.
SUMMARY OF THE INVENTION
The present invention is directed towards an integratable biomechanical implant construct comprising plural components inclusive of 1) a biomechanical spacer implant for insertion within an intervertebral space, 2) an anterior, posterior or lateral instrumentation component effective for vertebral body fixation and maintenance of the biomechanical spacer implant within the intervertebral space, and 3) a plurality of fastener components effective for securing the biomechanical implant construct to the vertebral bodies. The biomechanical spacer implant and anterior instrumentation component are designed for removable locking engagement, one with the other, for insertion by the surgeon as a unitary construct. It is contemplated that the biomechanical implant construct may be of either a unitary or a modular construction. When a unitary construction is provided, a single molded construction, e.g. of PEEK, titanium, or the like, can form the entire construct. In the case where the unitary construct is formed from a polymeric material, the through holes formed within the anterior instrumentation component may be reinforced for retention of the screw retainer components by incorporation of a metallic insert to make possible the novel anterior instrumentation/fastener component locking feature specific to the present invention.
A unique feature of the construct resides within the anterior instrumentation construction, whereby a single opening formed within the anterior instrumentation permits two bone screws, or the like fastener elements, to be positioned within both the superior and inferior vertebral bodies surrounding the spacer implant or, for example in the case of a corpectomy or diskectomy with cage insertion, wherein two screws can be fixed within a single vertebral body through a single through hole, and wherein the bone screws are constructed and arranged to cooperate with the anterior instrumentation so as to provide locking engagement, one to the other, with the anterior instrumentation, upon final fixation thereof. The use of a single screw hole allows the use of a relatively smaller faceplate than is possible with prior art designs, thus providing a more compact device which decreases the profile of the implant and concomitantly results in a decrease in esophageal compression.
Alternative embodiments are illustrated inclusive of a horizontal spaced orientation and a vertical spaced orientation. In the horizontal spaced orientation the screws are aligned side-by-side with alternate screws targeting the superior and inferior vertebral bodies respectively. In the vertical spaced orientation, the screws are stacked one above the other to allow for a more compact footprint, and again alternate between the superior and inferior vertebral bodies. Common to all embodiments is a borehole or through-hole assembly, which includes arcuate and dished curvilinear sidewalls. These sidewalls are designed to cooperate with the curved faces of the screwheads to urge the screwheads into a convergent relationship with one another and with the borehole assembly, whereby the act of tightening the bone screws within the common borehole assembly forces the screwheads and borehole assembly into locking engagement with one another when fully seated.
As an additional safety feature to guard against screw separation in the event of accidental backing out or breakage of the screws, a unique screw retainer component is further provided. The screw retainer component comprises an “open eight” retention clip within an area of the anterior instrumentation designed to receive it. In the horizontal spaced orientation the screw retainer component is illustrated as being in the form of a planar retention clip, while in the vertical spaced orientation, the clip is bent to conform to the internal shape of the anterior instrumentation access hole. In both cases, the screw retainer component is designed to deflect during insertion of each screw, and then return to its original position to prevent a loosened or broken screw from falling out of the anterior instrumentation.
The implant of the present invention preferably may be inserted using a one-step implantation process, as compared to a two-step process. Furthermore, the aspect is minimized due to the novel construction of the retention plate portion, thereby permitting the inferior and superior fixation to be essentially coplanar, thus eliminating the exacerbation of instability that may be caused by off-center loading resulting from the placement of multiple fasteners about areas of flexion or extension. The use of minimal aspect fixation should further minimize irritation of soft tissue, while providing improved segmental stability in flexion, extension and rotation.
Accordingly, it is an objective of the instant invention to provide a biomechanical implant and anterior instrumentation construct comprised of an intervertebral implant and a retention member which are constructed and arranged to form a permanent, rigid connection with bone fixation elements, so that, even if the bone structure is weakened, there is no loosening between the anterior instrumentation and the bone fixation elements. Moreover, the construct with biomechanical implant (stabilizer) enables superior and inferior vertebral fixation by multiple bone fixation elements via a single through hole, such that, upon fixation to the bony elements, said multiple fixation elements are in frictional engagement with each other and with the implant retention member, whereby all bone fixation elements are secured simultaneously.
It is an additional objective of the instant invention to provide a screw retainer component to guard against escape of a dislodged screw from the device.
It is a further objective of the instant invention to provide an intervertebral biomechanical implant and anterior instrumentation construct suitable for insertion by either an anterior, posterior or lateral surgical approach.
It is yet an additional objective of the instant invention to provide an alternative embodiment which will further enhance the frictional engagement and locking characteristics of the present invention by modifying the instantly disclosed anterior instrumentation and bone fastener elements to utilize elements of the TIFIX® locking technology, in accordance with the teaching of U.S. Pat. No. 6,322,562, the contents of which is herein incorporated by reference, whereby each screw head forms an autogenic lock to the plate upon insertion.
The present invention accomplishes the objectives set out above by providing a biomechanical implant and anterior instrumentation construct, comprising a three-dimensional body having an upper side and an under side which are suitable for abutting the end plates of two adjacent vertebral bodies. The three-dimensional body further includes a left side surface and a right side surface, a front surface and a rear surface, a horizontal middle plane between the upper side and the under side, and a vertical middle plane extending from the front surface to the rear surface. The intervertebral implant assembly further includes a construct inclusive of a biomechanical implant and anterior instrumentation which may form a unitary construct inclusive of the implant or be designed for removable engagement with the three-dimensional intervertebral implant body, wherein the retention member includes a plurality of boreholes, each of said boreholes designed for reception of at least two bone fixation elements, positionable in the superior and inferior vertebral bodies adjacent the intervertebral implant, such that, upon fixation to the bony elements, said multiple fixation elements are in frictional engagement with each other and with the implant retention member, whereby all bone fixation elements are secured simultaneously.
Other objects and advantages of this invention will become apparent from the following description taken in conjunction with any accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention. Any drawings contained herein constitute a part of this specification and include exemplary embodiments of the present invention and illustrate various objects and features thereof.



BRIEF DESCRIPTION OF THE FIGURES
FIG. 1 illustrates a cross-sectional view of a biomechanical implant construct, in accordance with the instant invention, inserted within the intervertebral space, and fixated to both the superior and inferior vertebral bodies adjacent thereto;
FIG. 2A illustrates a top-view of a biomechanical implant construct as positioned in FIG. 1, illustrating the bone fixation elements positioned in the adjacent superior and inferior vertebral bodies, and in locking engagement with the retention member;
FIG. 2B illustrates a top-view of a biomechanical implant construct as positioned in FIG. 1, illustrating through holes positioned so as to enable two bone fixation elements to be separately positioned within one or both of the adjacent superior or inferior vertebral bodies, and in locking engagement with the retention member;
FIG. 3A is an illustrative embodiment of a biomechanical implant construct;
FIG. 3B is a further illustrative embodiment of a biomechanical implant construct;
FIG. 3C is yet another illustrative embodiment of a biomechanical implant construct;
FIG. 4 illustrates a perspective view of a biomechanical implant and anterior instrumentation construct in accordance with the instant invention, in a vertically spaced configuration;
FIG. 5 illustrates a top-view of the biomechanical implant and anterior instrumentation construct of FIG. 4;
FIG. 6 illustrates a bent open eight screw retainer component for use in the biomechanical implant construct of FIGS. 4 and 5;
FIG. 7 is an illustrative embodiment of a biomechanical implant body alone;
FIG. 8 illustrates a first perspective view of a biomechanical implant and anterior instrumentation construct in accordance with the instant invention, in a horizontally spaced configuration;
FIG. 9 illustrates a second perspective view of the biomechanical implant and anterior instrumentation construct of FIG. 8;
FIG. 10 illustrates a flat open eight screw retainer component for use in the intervertebral implant assembly of FIGS. 8 and 9;
FIG. 11 illustrates an alternative view of the biomechanical implant and anterior instrumentation construct of FIGS. 8 and 9;
FIG. 12 is an illustrative embodiment of the biomechanical implant body alone;
FIG. 13 illustrates the cooperation between the dished and curvilinear seat of the anterior instrumentation and the bone fastening elements upon tightening, to affect a locking engagement therebetween;
FIG. 14 illustrates a lower side view of the exiting of the bone fastening elements from the anterior instrumentation of the implant of FIG. 13;
FIG. 15A is a top view of an elongated borehole slot surrounded by an arcuate and curvilinear seat formed within an anterior instrumentation;
FIG. 15B is a cross-sectional view of FIG. 15A along line A-A;
FIG. 15C is a cross-sectional view of FIG. 15A along line B-B;
FIG. 16 is a front perspective view, partially in section, of a vertically spaced biomechanical implant assembly further including anchoring tabs for attachment to the anterior cortical vertebral surfaces;
FIG. 17 is a front perspective view, partially in section, of a horizontally spaced biomechanical implant assembly further including anchoring tabs for attachment to the anterior cortical vertebral surfaces;
FIG. 18 is a front perspective view, partially in section, of a horizontally spaced biomechanical implant assembly for lateral insertion, including anchoring tabs for attachment to the lateral cortical vertebral surfaces;
FIG. 19 is a front perspective view, partially in section, of a vertically spaced biomechanical implant assembly for lateral insertion, including anchoring tabs for attachment to the lateral cortical vertebral surfaces;
FIG. 20 is a cross-sectional view of a prior art TIFIX plate and screw combination.



DETAILED DESCRIPTION OF THE INVENTION
Now referring to FIG. 1, the intervertebral implant assembly, generally referred to by numeral 10, includes an implant member 12, and a retention member 14, illustrated as, albeit not limited to, a bone plate. Both plate 14 and implant 12 may be formed of PEEK (poly(ether ether ketone)), titanium, titanium alloy, stainless steel, allograft bone or any other suitable, biocompatible material. It is contemplated that implant 12 may be formed of bone, or an artificial material other than bone which may be harder and/or stronger than bone, such as plastic or ceramic materials. It is further contemplated that the implant material will have the same, more or less elasticity than bone. The implant 12 may include, or be treated with, a bone growth promoting material such as, but not limited to, bone morphogenic protein, hydroxyapatite, and genes coding for the production of bone. Implant 12 may be a source for osteogenesis, be at least in part bioabsorbable, and be treated with, or applied in conjunction with a substance, as known in the art, to inhibit scar formation and/or promote fusion of the bones. Preferably retention member 14 is 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. Bone fixation elements 16, illustrated, albeit not limited to bone screws, may be formed of titanium, titanium alloy or stainless steel. The bone fixation elements 16 may be in the form of a screw, a staple or nail, a fluted cannulated screw or nail with collapsible/deployable spurs which are deployed and thereby embedded within the bone upon insertion of a secondary nail or screw within the cannulated space, or similar functionally equivalent elements. Furthermore, the implant 12 may include one or more openings (FIG. 3B, 42) designed to receive bone graft material. Subsequent to insertion of the intervertebral implant assembly 10 within the intervertebral space, bone fixation elements, e.g. screws 16, are driven into the inferior 20 and superior 18 adjacent vertebral bodies, via access through hole 17. Upon being fixated within said access hole 17, the elements 16 are urged into locking engagement with the curvilinear seat of anterior instrumentation retention member 14, and each other, so as to reduce or eliminate the possibility of loosening. Due to the single access hole design, the screws essentially reside in a single plane common to the superior and inferior vertebral bodies, and have adjustable angularity at the surgeon's discretion.
It is contemplated by the invention that the access through hole 17 may include a single exit aperture or dual diverging exit apertures. The seat of each aperture, whether integral with the assembly, or formed within a metallic insert which is subsequently inserted into the assembly, may include a spherical or semi-spherical dished and curvilinear seat for each fastener. This feature will provide for variation in screw trajectory and increased face contact between the fixation elements and the plate or seat. In a preferred albeit non-limiting embodiment, the fastener will be formed with a spherical or semi-spherical head with a substantially flat upper surface. Such construction will allow the spherical surface of the second fastener, e.g. screw, to engage the top surface of the first screw regardless of trajectory of both screws. Such construction insures repeatable and reliable head-to-head contact independent of fastener trajectories.
In a particular embodiment of this invention the stabilizing bone plate useful in an interbody fusion system for stabilizing a biomechanical spinal implant will be comprised of a bone plate having a left side surface and a right side surface, a top surface and a bottom surface, a first upper surface and a second lower surface, with a distance between said first upper surface and said second lower surface defining a thickness of said plate, a horizontal middle plane between the first upper surface and the second lower surface and a plurality of boreholes suitable for accommodating longitudinal fixation elements extending through said thickness of said plate, wherein each of said boreholes has an elongated slot located at or near said horizontal middle plane, and surrounded by arcuate and dished curvilinear sidewalls which form an engagement seat extending from said elongated slot to said first upper surface for receiving at least two bone fixation elements therein, each of said bone fixation elements having a screw head adapted to engage or be engaged by an engaging surface of each screw head to urge the screw heads into a convergent and interference relationship with one another and with said engagement seat upon tightening, thereby resulting in a locking engagement of said bone plate engagement seat and said fixation elements and a diverging outlet portion extending from said elongated slot toward said second lower surface, said divergent outlet being adapted to provide a range of angulation of each said fixation elements, whereby each of said fixation elements is individually positionable within both an inferior and superior vertebral body associated with said interbody fusion system.
Now referring to FIG. 2A, the interlocking frictional engagement of the elements 16 and retention member 14 are further illustrated as they reside in through hole 17. Alternatively, as illustrated in FIG. 2B, the through hole(s) 17 may be formed so as to enable two bone fixation elements 16 to be deployed through a single through hole 17, and to be separately positioned within one or both of the adjacent superior or inferior vertebral bodies, and in locking engagement with the retention member 14.
With reference to FIGS. 3A, 3B and 3C, alternative illustrative embodiments, in accordance with the inventive concept are illustrated. Such embodiments are for illustration purposes, and are not meant to limit the invention, as further equivalent alternative embodiments are contemplated.
Referring to FIG. 3A, implant 12A shows one illustrative embodiment of a biomechanical implant element wherein the element includes one or more keel-like members 30. The attachment of plate 14A and implant 12A is accomplished via pins 32, which are designed for frictional insertion and engagement with mating recesses (not shown), in plate 14A. When positioned within the intervertebral space, fixation elements, e.g. screws 16, are inserted via access through-hole 17, and may follow the trajectory delineated by optional upper and lower guides 48 and 49 respectively.
Referring to FIG. 3B, implant 12B shows another illustrative embodiment of a biomechanical implant element wherein the element includes openings 42 for the insertion of bone graft material. The attachment of plate 14B and implant (graft/spacer) 12B is accomplished via coupling of male and female T-slot members 44 and 46. When positioned within the intervertebral space, fixation elements, e.g. screws 16 (not shown), are inserted via access through-holes 17 and 17′, and may follow the trajectory delineated by optional upper and lower guides 48 and 49 respectively. It is noted that this embodiment illustrates plural access through holes 17 and 17′, and when plate 14B is constructed from PEEK, the curvilinear through-hole engagement surface is formed from a metallic material, e.g. titanium, and inserted or molded into the PEEK implant to form a reinforced version of through-holes as illustrated at 17 and 17′.
Referring to FIG. 3C, implant 12C shows another illustrative embodiment of a biomechanical implant element wherein the element includes facets 50 for enhanced gripping of the adjacent vertebral bodies 18 and 20. The attachment of plate 14C and biomechanical implant 12C is illustratively accomplished via coupling of plural male and female T-slot members 44C and 46C. When positioned within the intervertebral space, fixation elements, e.g. screws 16 (not shown), are inserted via access through-hole 17, and may follow the trajectory delineated by optional upper and lower guides 48 and 49 respectively.
In a particular embodiment, the biomechanical spacer implant of the invention is adapted for insertion within an intervertebral space between a superior vertebral body and an inferior vertebral body and includes a first insertion end portion, a second end portion opposite the first end portion, a first lateral side portion, a second lateral side portion, an upper surface and a lower surface.
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 at which the spacer is intended to be inserted. The shape of the perimeter of the spacer can be modified for cervical applications, or for other areas such as in the lumbar or thoracic area of the spine.
Forms of attachment between the biomechanical implant element and the anterior instrumentation member are not limited to the mechanisms depicted. Furthermore, the number and position of access through-holes e.g. two, three, four or the like, is dictated by the particular patient's anatomy or other surgical considerations, and is also not intended to be limited by the type of attachment mechanism between the biomechanical implant and anterior instrumentation.
It is contemplated that the implant may include a series of teeth (FIG. 1, 19), knurling, ridges or similar projections, to aid in securing the implant to the vertebral endplates. It is also contemplated that the upper and/or lower surfaces of implant 12 may be smooth, having ridges (not shown) that run laterally with respect to the spacer, or ridges running from front to back.
It is further contemplated that the access through holes 17 provided in the plates may be threaded or smooth, and the screws or alternative bone fasteners inserted through the plate may have a head that also may be threaded or smooth. In this regard, and with reference to FIG. 20, the present invention contemplates an embodiment which incorporates the TIFIX technology disclosed by Wolter, in U.S. Pat. No. 6,322,562, wherein the bone screw may further include a preformed thread below the bone screw seat surface, the preformed thread deforming a portion of the passage hole below the seat surface of the connection carrier when the bone screw is screwed in so that a thread connection is formed between the bone screw thread and the connection carrier, the deformation being formed by rotating the bone screw at a certain angle to the connection carrier. In addition to use of bone screws, per se, such as disclosed by Wolter, the present invention further contemplates alternative embodiments wherein the preformed thread consists of a harder material than the deformable projection, wherein the bone screw or its casing is of a harder material than the connection carrier or the region to be deformed, wherein the casing region of the locking bolt has a lesser hardness than the bonemarrow nail at least in the region of the inner thread, wherein the connection carrier comprises a sensor for determining the force transmitted by the connection carrier between the bone ends and a transmitter for the telemetric transfer of the readings, and wherein the sensor and/or transmitter are integrated into a cavity of the connection carrier.
The implants described herein may be sized and configured for anterior, posterior or lateral approaches and insertion. 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.
To improve the anchoring of the bone fixation element in any of the illustrative embodiments contemplated by the present invention where the retention member is formed of a polymeric material, a metal sleeve with or without an internal thread, as illustrated in FIG. 3B, may be inserted in the access through hole 17. The intervertebral implant may also consist only partially of an x-ray transparent plastic and, in the region of the upper and lower guides (48,49) consist of a metal, such as titanium or a titanium alloy. Improved guidance and anchoring of the bone fixation elements may thereby be achieved. Further, the access through-holes may have a smooth internal wall, into which the threaded head or body of a metallic, longitudinal fixation element may cut or be molded.
Now referring to FIG. 4, the biomechanical implant and anterior instrumentation construct, generally referred to by numeral 10, includes an implant member 12, and a retention member 14, illustrated as, albeit not limited to, a bone plate. Both biomechanical implant 12 and anterior instrumentation construct 14 may be formed of PEEK, titanium, titanium alloy, stainless steel, allograft bone or any other suitable, biocompatible material. Preferably retention member 14 is 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. Bone fixation elements 16, illustrated, albeit not limited to bone screws, may be formed of titanium, titanium alloy, stainless steel or other biocompatible materials. The bone fixation elements 16 may be in the form of a screw, a staple or nail, a fluted cannulated screw or nail with collapsible/deployable spurs which are deployed and thereby embedded within the bone upon insertion of a secondary nail or screw within the cannulated space, or similar elements. Furthermore, the implant 12 may include one or more openings (not shown) designed to receive bone graft material. Subsequent to insertion of the biomechanical implant and anterior instrumentation construct 10 within an intervertebral space (not illustrated), bone fixation elements, e.g. screws 16, are driven into the inferior and superior adjacent vertebral bodies, via an access through hole or borehole 17. Upon being fixated within said access hole 17, the elements 16 are in locking engagement with the retention member 14, and each other, so as to reduce or eliminate the possibility of loosening. In the vertical spaced orientation as shown, due to the single access hole design, the screws essentially reside in a single plane common to the superior and inferior vertebral bodies.
It is contemplated by the invention that each borehole 17 may include a single exit aperture or dual diverging exit apertures at the rear surface of the anterior instrumentation 14. The engagement seat of each aperture, whether integral with the assembly, or formed within a metallic insert that is subsequently inserted into the assembly, may include a spherical or semi-spherical dished and curvilinear seat for each fastener. This feature will enable variations in the choice of screw trajectory and increased face contact between the fixation elements and the plate or seat. In a preferred albeit non-limiting embodiment, the fastener element 16 will be formed with a spherical or semi-spherical head with a substantially flat upper surface. Such construction will allow the spherical surface of the second fastener, e.g. screw, to engage the top surface of the first screw regardless of trajectory of both screws, as the second screw is tightened and urged into frictional engagement with the first screw by contact with the dished and curvilinear engagement seat formed within the upper or entry surface of borehole 17. Such construction insures repeatable and reliable head-to-head contact independent of fastener trajectories.
Now referring to FIG. 5, a top-view of the intervertebral implant assembly 10 of FIG. 4 is illustrated. This view best illustrates the bent open eight retention clip 15 as positioned within a prefabricated groove in borehole 17. In order to form a prefabricated and unitary assembly for simplified insertion during surgery, clip 15 is initially compressed by inserting a tool into holes 19 so as to enable the compressed clip to be inserted and thereby engage with reception grooves formed at the periphery of borehole 17. Subsequent to compression of the clip via holes 19 and insertion into borehole 17, the retention ring/clip 15 and retention member 14 form a unitary assembly. Each of the fixation elements 16 can be inserted individually in their respective apertures, and the retention ring 15 is designed to deflect so as to enable the heads of the fixation elements 16 to pass therethrough, and then return to its prior position to prevent the fixation element from falling out of borehole 17 should it become loosened.
Referring to FIG. 6 the bent open eight retention clip 15 is more clearly illustrated. The bent configuration allows functionality in the vertical spaced orientation as illustrated, by providing a single clip which functions for both fixation elements.
Referring to FIG. 7 implant member 12 is an illustrative embodiment of an implant element. The element may contain openings (not shown here) for the insertion of bone graft material. The attachment of plate 14 and implant 12 is accomplished via coupling of male and female T-slot members 44 and 46 (more clearly illustrated in FIG. 9). When positioned within an intervertebral space, fixation elements, e.g. screws 16 (not shown), are inserted via access through-holes 17, and may follow the trajectory delineated by optional guides 48 and 49 respectively.
Referring to FIG. 8 illustrated herein is a first perspective view of a biomechanical implant and anterior instrumentation construct, in accordance with the instant invention, in a horizontally spaced configuration. Although the configuration of the boreholes and plates is slightly different between the vertically and horizontally spaced embodiments, the numbering has nevertheless been left consistent for ease of explanation. This is an alternative embodiment wherein, dependent upon the physiology and anatomy, it may be more desirable to position fixation elements 16 side by side, as opposed to vertically stacked. The functioning of the various elements is otherwise equivalent, except for the fact that the open eight screw retainer component 15, as illustrated in FIG. 10 is of a flat, rather than a bent, design.
Referring to FIG. 9, a second perspective view of the biomechanical implant and anterior instrumentation construct of FIG. 8 is illustrated which more clearly depict the male/female T-slot configuration by which members 12 and 14 are assembled. It is stressed that this is merely one illustrative means of attachment of members 12 and 14 and any other functionally equivalent means of attachment are deemed to be within the purview of this invention.
Referring to FIG. 10, illustrated here is a flat open eight screw retainer component 15 for use in a biomechanical implant and anterior instrumentation construct of FIGS. 8 and 9. The functionality is equivalent to that of the bent design of FIG. 6 as previously outlined above.
Referring to FIG. 11 an alternative view of the biomechanical implant and anterior instrumentation construct of FIGS. 8 and 9 is further illustrated.
Referring to FIG. 12, an illustrative embodiment of the intervertebral biomechanical implant member 12 is shown which illustrates the trajectory guiding elements 48 and 49, as they are positioned within the horizontally spaced configuration. Although a very basic illustration of implant member 12 is shown for ease of illustration, it is understood that the implant element 12 may include facets for enhanced gripping of the adjacent vertebral bodies. 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 can be modified for cervical applications, or for other areas such as in the lumbar or thoracic areas of the spine.
It is contemplated that the implant may include a series of teeth, knurling, ridges or similar projections, to aid in securing the implant to the vertebral endplates. It is also contemplated that the upper and/or lower surfaces of implant 12 may be smooth, having ridges (not shown) that run laterally with respect to the spacer, or ridges running from front to back.
It is reiterated that forms of attachment between the implant element 12 and the anterior instrumentation 14 are not limited to the mechanisms depicted. Furthermore, the number and position of access through-holes e.g. two, three, four or the like, is dictated by the particular patient's anatomy or other surgical considerations, and is also not intended to be limited by the type of attachment mechanism between the implant 12 and the biomechanical implant and anterior instrumentation construct 14.
As previously set forth, it is further contemplated that the access through holes 17 provided in all plates illustrated herein, may be threaded or smooth, and the fixation elements 16, such as screws or alternative bone fasteners inserted through the plate may have a head that also may be threaded or smooth.
All implants described herein may be sized and configured for anterior, posterior or lateral approaches and insertion. 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.
Referring to FIG. 13 the cooperation between the dished and curvilinear seat illustrated within the entry area of borehole 17 is illustrated, showing the cooperation between the seat area and the heads of the bone fastening elements 16 upon tightening, to affect a locking engagement therebetween;
With reference to FIG. 14 illustrates, a view of the lower side of instrumentation plate 14A shows divergent exiting of the bone fastening elements 16 toward the inferior and superior vertebral bodies, from the anterior instrumentation of the implant of FIG. 13;
Now referring to FIG. 15A is an illustrative embodiment showing a top view of an elongated borehole slot 17B surrounded by an arcuate and dished curvilinear seat 17A formed within the instrumentation plate 14A;
Referring to FIG. 15B, illustrated herein is a cross-sectional view of FIG. 15A along line A-A, showing the dished and curvilinear shape of seat 17A, which will cooperate with relatively congruent shaped screw heads provided to bone screws 16 (not shown here for clarity), in order to enhance the cooperation between these elements during the fixation process, so as to urge the screw heads and engagement seat into a locking frictional engagement;
With further reference to FIG. 15C, shown here is a cross-sectional view of FIG. 15A along line B-B, which illustrates the exit aperture 17C, which enables the discretion in angular placement of the fixation elements 16, into the vertebral bodies, as desired by the surgeon.
Referring now to FIG. 16, is a front perspective view is shown, partially in section, of a vertically spaced biomechanical implant assembly 12, with stabilizing anterior instrumentation 14, further including anchoring tabs 50 for attachment to the anterior cortical vertebral surfaces. This embodiment provides the surgeon with the utility of attachment of additional stabilization through the anterior cortical bone surfaces by insertion of a fastener element 16, through tab 50, which is retained by deflectable retention element 15A, which is a further variation on the “open-eight” retention element technology illustrated in earlier embodiments. The partial sectional view affords an alternative view of the relationship of bent retention element 15B, within a reception groove formed in plate 14, in this vertically oriented configuration.
With reference to FIG. 17, a front perspective view, partially in section, of a horizontally spaced biomechanical implant assembly further including anchoring tabs for attachment to the anterior cortical vertebral surfaces is shown. This assemblage is essentially the same as that described in FIG. 16 above, save for the fact that it is configured to be horizontally oriented so as to provide an alternate bone screw placement. The flat open eight retention member 15C is illustrated placed within a retention groove formed with instrumentation plate 14 for retention thereof.
Referring to FIG. 18, shown herein is a front perspective view, partially in section, of a horizontally spaced biomechanical implant assembly, as illustrated in FIG. 17, however configured for lateral insertion, including anchoring tabs for attachment to the lateral cortical vertebral surfaces.
With further reference to FIG. 19, a front perspective view, partially in section, of a vertically spaced biomechanical implant assembly for lateral insertion, including anchoring tabs for attachment to the lateral cortical vertebral surfaces is also shown.
FIG. 20 is a cross-sectional view of a prior art TIFIX plate and screw combination. It is contemplated that any of the herein illustrated and referenced embodiments could be modified to contain the TIFIX technology. Such incorporation might include merely selecting the relative hardnesses of the materials used in the fixation elements 16 and plates 14, 14A, etc. so as to provide thread forming ability and autogenic locking, in the manner described by Wolter '562. Additionally, it is further contemplated to modify the bone fixation elements 16, to include secondary threads for locking into the plate as shown in prior art FIG. 20 from the Wolter '562 patent.
All patents and publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains. All patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference.
It is to be understood that while a certain form of the invention is illustrated, it is not to be limited to the specific form or arrangement herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and any drawings/figures included herein.
One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The embodiments, methods, procedures and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims.

## Claims

1. An implant assembly, comprising:
an implant member;
a plate configured to be coupled with the implant member, the plate defining a horizontal plane and including:
at least one bore through the plate, the bore having an inlet aperture and at least one exit aperture, the inlet aperture having a curvilinear seat;
a first fastener configured for insertion through the at least one bore, the first fastener having a curved portion; and
a second fastener configured for insertion through the at least one bore, the second fastener having a curved portion;

wherein the curved portions of the first and second fasteners are configured to contact the curvilinear seat to secure the plate to the implant member, and wherein the first and second fasteners extend in coplanar relation along a plane transverse to the horizontal plane.

2. The implant assembly of claim 1, wherein the plate is configured to transmit a force exerted by the fastener to the implant member.

3. The implant assembly of claim 1, wherein the plate includes at least one additional fastener, each of the fasteners disposed at an oblique angle with respect to the horizontal plane.

4. The implant assembly of claim 3, wherein the fasteners extend away from a common point of engagement.

5. The implant assembly of claim 3, wherein the fasteners are arranged such that each fastener is securely maintained within the at least one bore.

6. The implant assembly of claim 1, wherein the curvilinear seat is an insert within the plate.

7. The implant assembly of claim 1, wherein a resilient member is disposed about a portion of at least one of the fasteners.

8. An implant assembly, comprising;
an implant member;
a plate configured for engagement with the implant member and defining a horizontal plane;
a plurality of fasteners extending through the plate through a common inlet, each fastener having a curved head;
a curvilinear seat disposed within the common inlet;
wherein at least two of the fasteners extend through common inlet at oblique angles relative to the plate and coplanar along a plane transverse to the horizontal plane, and the curved head of each fastener engages the curvilinear seat.

9. The implant assembly of claim 8, wherein the plurality of fasteners are arranged such that curved heads of adjacent fasteners are maintained in surface contact.

10. The implant assembly of claim 8, wherein the curved head of each fastener is complementary to the geometry of the curvilinear seat.

11. The implant assembly of claim 8, wherein the curvilinear seat is separable from the plate.

12. The implant assembly of claim 8, wherein the plate includes a plurality of spaced outlets, and a diverging bore extends between the common inlet and at least two of the spaced outlets.

13. The implant assembly of claim 8, wherein a flexible member is circumferentially disposed about at least one of the fasteners.

14. An implant assembly, comprising:
a plurality of fasteners, each fastener including a head and a shank extending therefrom;
a plate defining a rear surface including a plurality of openings for receiving the respective fasteners, wherein at least one fastener is oriented towards a first vertebra along an axis perpendicular to the rear surface of the plate and at least one fastener is oriented towards a second vertebra along an axis perpendicular to the rear surface of the plate, the plate including a first structure, wherein the head of each fastener of the plurality of fasteners are arranged to overlap; and
an implant member positionable between adjacent vertebral bodies, the implant member having a second structure and including a plurality of guides, each guide aligned with a corresponding opening for orienting a trajectory of the respective fastener inserted therethrough, wherein the first structure of the plate and second structure of the implant member cooperate to maintain relative positioning of the plate and the implant member in a direction that is transverse to a longitudinal axis of the vertebrae.

15. The implant assembly of claim 14, wherein the fasteners cooperate with the plate for securely maintaining the fasteners within their respective openings.

16. The implant assembly of claim 14, wherein the plate and the implant member are repositionable with respect to each other in a direction that is parallel to the longitudinal axis of the vertebrae.

17. The implant assembly of claim 14, wherein each fastener cooperates with an arcuate surface of the respective opening in the plate for locking the fastener in the opening.

18. The implant assembly of claim 14, wherein opposing surfaces of the implant include structures for engaging endplates of the adjacent vertebrae.

19. The implant assembly of claim 18, wherein the structures are selected from the group consisting of: teeth, keel members, and anchoring tabs.

20. The implant assembly of claim 14, further including openings for receiving bone graft material.

21. An implant assembly, comprising:
an implant member defining an engagement surface configured for engaging a vertebral endplate;
first and second bores through the implant member, each bore having an inlet aperture and at least one exit aperture,
a first fastener configured for insertion through the first bore along and extending parallel to the engagement surface of the implant member;
a second fastener configured for insertion through the second bore at an oblique angle to the engagement surface of the implant member.

22. The implant assembly of claim 21, further comprising a plate abutting the implant member.

23. The implant assembly of claim 22, wherein the plate defines a bore extending therethrough, the bore of the plate aligned with one of the first and second bores of the implant member.

24. The implant assembly of claim 21, wherein the plate defines an inlet aperture having a curvilinear seat.

25. The implant assembly of claim 24, wherein the first fastener and the second fastener each have a curved portion, the curved portion configured to contact the curvilinear seat.

26. The implant assembly of claim 22, wherein the plate and the implant member have a unitary construction.

27. The implant assembly of claim 22, wherein the plate and the implant member are separable.

28. The implant assembly of claim 21, wherein the first fastener is laterally spaced from the engagement surface of the implant and laterally spaced from the second fastener.

29. The implant assembly of claim 21, wherein the implant member includes an anchoring tab extending away from the engagement surface.

30. The implant assembly of claim 29, wherein the anchoring tab is configured to receive one of the first and second fasteners.