Artificial hemi-lumbar interbody spinal fusion cage having an asymmetrical leading end

Abstract
An artificial interbody spinal implant adapted for placement across an intervertebral space formed across the height of a disc space between two adjacent vertebral bodies is disclosed. The implant has an asymmetrical leading end adapted to sit upon the more peripheral areas, such as the apophyseal rim and the apophyseal rim area, of the vertebral end plate region of the vertebral bodies without protruding therefrom. The asymmetrical leading end allows for the sate use of an implant of maximum length for the implantation space into which it is installed. The implant can also include an asymmetric trailing end adapted to sit upon the more peripheral areas of the vertebral end plate region of the vertebral bodies.
Description
BACKGROUND OF THE INVENTION

1. Field of the Invention


The present invention relates generally to interbody spinal implants preferably adapted for placement in pairs side by side to either side of the midline with or without a space therebetween into a space created across the height of a disc space and between two adjacent vertebral bodies, after the removal of damaged spinal disc material, for the purpose of correcting spinal disease at that interspace. The spinal implants are made of an implant material that is other than bone and may or may not be resorbable. Where the implants are spinal fusion implants, they are adapted such that fusion occurs at least in part through the implants themselves. Where the implants are motion preserving for maintaining spinal motion, bone growth can occur at least in part into the spinal implants themselves, but not across them, and they are adapted to allow for relative motion between the vertebrae.


2. Description of the Related Art


Surgical interbody spinal fusion generally refers to the methods for achieving a bridge of bone tissue in continuity between adjacent vertebral bodies and across the disc space to thereby substantially eliminate relative motion between the adjacent vertebral bodies. The term “disc space” refers to the space between adjacent vertebral bodies normally occupied by a spinal disc.


Motion preserving implants maintain the spacing between the two adjacent vertebral bodies and allow for relative motion between the vertebrae. Bone growth from the adjacent vertebral bodies into the motion preserving implant, but not through the implant, anchors the implant to the adjacent vertebral bodies while preserving the relative motion between the vertebrae.


Spinal implants can have opposed upper and lower surfaces that are arcuate or non-arcuate transverse to the longitudinal axis of the implant along at least a portion of the length of the implant. Implants having arcuate opposed portions are adapted to be implanted across and beyond the height of the restored disc space, generally into a bore formed across the height of a disc space. Some of the advantages offered by implants with arcuate opposed portions include: 1) the installation of the implant into vascular bone made possible by the creation of a bore into the bone of the adjacent vertebral bodies; 2) the implant's geometric shape is easy to manufacturer; 3) the implant can include external threads to facilitate insertion into the implantation space; and 4) the implant provides more surface area to contact the adjacent vertebral bodies than would a flat surface. Some disadvantages associated with implants having arcuate opposed portions include; 1) the creation of a bore into the adjacent vertebral bodies to form the implantation space results in a loss of the best structural bone of the vertebral endplate; 2) the implant needs to have a larger cross section to fill the prepared implantation site which may be more difficult to install, especially from a posterior approach; and 3) the width of the implant is generally related to the height of the implant, so if the implant is for example a cylinder, the width of the implant may be a limiting factor as to the height of the implant and therefore to the possible usefulness of the implant.


Implants having non-arcuate upper and lower opposed portions may be impacted into a space resembling the restored disc space and need only be placed against a “decorticated endplate.” A decorticated endplate is prepared by the surgeon to provide access to the underlying vascular bone. Some of the advantages provided by implants having non-arcuate opposed portions include: 1) preserving the best bone in the endplate region; 2) the height of the implant is independent of its width; 3) the implant can be of a geometric shape and the opposed upper and lower surfaces can be flat; 4) the implants can be installed as part of a modular unit; and 5) the implants can provide a broad surface contact. Some of the disadvantages provided by implants having non-arcuate opposed portions include: 1) the implants cannot be threaded in and must be impacted into the installation space; and 2) the recipient site may be more difficult to prepare.


Human vertebral bodies have a hard outer shell of compacted dense cancellous bone (sometimes referred to as the cortex) and a relatively softer, inner mass of cancellous bone. Just below the cortex adjacent the disc is a region of bone referred to herein as the “subchondral zone”. The outer shell of compact bone (the boney endplate) adjacent to the spinal disc and the underlying subchondral zone are together herein referred to as the boney “end plate region” and, for the purposes of this application, is hereby so defined. A circumferential ring of dense bone extends around the perimeter of the endplate region and is the mature boney successor of the “apophyseal growth ring”. This circumferential ring is formed of very dense bone and for the purposes of this application will be referred to as the “apophyseal rim”. For the purposes of this application, the “apophyseal rim area” includes the apophyseal rim and additionally includes the dense bone immediately adjacent thereto. The spinal disc that normally resides between the adjacent vertebral bodies maintains the spacing between those vertebral bodies and, in a healthy spine, allows for the normal relative motion between the vertebral bodies.



FIG. 1 of the attached drawings shows a cross-sectional top plan view of a vertebral body V in the lumbar spine to illustrate the dense bone of the apophyseal rim AR present proximate the perimeter of the vertebral body V about the endplate region and an inner mass of cancellous bone CB. The structure of the vertebral body has been compared to a core of wet balsa wood encased in a laminate of white oak. The apophyseal rim AR is the best structural bone and is peripherally disposed in the endplate of the vertebral body.



FIG. 2 is a top plan view of a fourth level lumbar vertebral body V shown in relationship anteriorly with the aorta and vena cave (collectively referred to as the “great vessels” GV). FIG. 3 is a top plan view of a first sacral level vertebral body V shown in relationship anteriorly with the iliac arteries and veins referred to by the designation “IA-V”. Because of the location of these fragile blood vessels along the anterior aspects of the lumbar vertebrae, no hardware should protrude from between the vertebral bodies and into the great vessels GV and iliac arteries and veins IA-V.


Implants for use in human spinal surgery can be made of a variety of materials not naturally found in the human body. Such materials include surgical quality metals, ceramics, plastics and plastic composites, and other such materials suitable for the intended purpose. Further, these materials may be absorbable, bioactive such as an osteogenic material, or be adapted to deliver and/or contain fusion promoting substances such as any of bone morphogenetic protein, hydroxyapatite, and genes coding for the production of bone, and/or others. Fusion implants preferably have a structure designed to promote fusion of the adjacent vertebral bodies by allowing for the growth of bone through the implant from vertebral body to adjacent vertebral body. This type of implant is intended to remain indefinitely within the patient's spine unless made of a resorbable or bioresorbable material such as bone that can be biologically replaced in the body over time such that it need not be removed as it is replaced over time and will no longer be there. Implants may be sized to have a width generally as great as the nucleus portion of the disc or as wide as the area between the limit lines LL as shown in FIG. 4. There are at least two circumstances where the use of such a wide implant is not desirable. Under these circumstances, the use of a pair of implants each having a width less than one half the width of the disc space to be fused is preferred. The first circumstance is where the implants are for insertion into the lumbar spine from a posterior approach. Because of the presence of the dural sac within the spinal canal, the insertion of a full width implant in a neurologically intact patient could not be performed from a posterior approach. The second circumstance is where the implants are for endoscopic, such as laproscopic, insertion regardless of the approach as it is highly desirable to minimize the ultimate size cross-sectionally of the path of insertion.


The ability to achieve spinal fusion is inter alia directly related to the vascular surface area of contact over which the fusion can occur, the quality and the quantity of the fusion mass, and the stability of the construct. The overall size of interbody spinal fusion implants is limited, however, by the shape of the implants relative to the natural anatomy of the human spine. For example, if such implants were to protrude from the spine they might cause injury to one or more of the proximate vital structures including the large blood vessels or neurological structures.



FIG. 4 shows a top plan view of the endplate region of a vertebral body V with the outline of a related art implant A and implant 100 of one embodiment of the present invention installed, one on each side of the centerline of the vertebral body V. The length and width of related art implant A is limited by its configuration and the vascular structures anteriorly (in this example) adjacent to the implantation space. The presence of limiting corners LC on the implant precludes the surgeon from utilizing an implant of this configuration having both the optimal width and length because the implant would markedly protrude from the spine.


Related art implants also fail to maximally sit over the best structural bone, which is located peripherally in the apophyseal rim of the vertebral body and is formed of the cortex and dense subchondral bone. The configurations of previous implants do not allow for maximizing both the vital surface area over which fusion could occur and the area available to bear the considerable loads present across the spine. Previous implant configurations do not allow for the full utilization of the apophyseal rim bone and the bone adjacent to it, located proximate the perimeter of the vertebral body to support the implants at their leading ends and to maximize the overall support area and area of contact for the implants. The full utilization of this dense peripheral bone would be ideal.


Therefore, there is a need for an interbody spinal fusion implant having opposed portions for placement toward adjacent vertebral bodies that is capable of fitting within the outer boundaries of the vertebral bodies between which the implant, is to be inserted and to maximize the surface area of contact of the implant and vertebral bone. The implant should achieve this purpose without interfering with the great vessels or neurological structures adjacent to the vertebrae into which the implant is to be implanted. There exists a further need for an implant that is adapted for placement more fully on the dense cortical bone proximate the perimeter of the vertebral bodies at the implant's leading end.


SUMMARY OF THE INVENTION

The present invention relates to an artificial spinal implant formed or manufactured prior to surgery and provided fully formed to the surgeon for use in interbody fusion made of an implant material other than bone that is appropriate for the intended purpose. The implant is of a width preferably sized to be used in pairs to generally replace all or a great portion of all of the width of the nucleus portion of the disc. To that end, the width of the implant is less than half of the width of the disc space. Preferably, the implant generally has parallel side walls and is used where it is desirable to insert an implant of enhanced length without the leading lateral wall protruding from the spine.


The interbody spinal implant of the present invention is for placement between adjacent vertebral bodies of a human spine across the height of disc space between those adjacent vertebral bodies. The implant preferably does not extend beyond the outer dimensions of the two vertebral bodies adjacent that disc space, and preferably maximizes the area of contact of the implant with the vertebral bone. In a preferred embodiment, the implant has a leading end configured to conform to the anatomic contour of at least a portion of the anterior, posterior, or lateral aspects of the vertebral bodies depending on the intended direction of insertion of the implant, so as to not protrude beyond the curved contours thereof. The implant has an asymmetrical leading end modified to allow for enhanced implant length without the corner of the leading end protruding out of the disc space. As used herein, the phrase “asymmetrical leading end” is defined as the leading end of the implant lacking symmetry from side-to-side along the transverse axis of the implant when the leading end is viewed from a top elevation.


The configuration of the leading end of the implant of the present invention allows for the safe use of an implant of maximum length for the implantation space into which it is installed. Benefits derived from a longer length implant include, but are not limited to, providing a greater surface area for contacting the vertebral bodies and for carrying bone growth promoting material at the implant surface, increased load bearing support, increased stability, and increased internal volume for holding fusion promoting material and the ability to have a portion of the implant rest upon the apophyseal rim, the best structural bone of the vertebral endplate region. These fusion promoting and bone growth promoting materials may be bone, bone products, bone morphogenetic proteins, mineralizing proteins, genetic materials coding for the production of bone or any other suitable material.


The spinal implant of the present invention may also include a trailing end opposite the leading end that is configured to conform to the anatomic contour of the anterior, posterior, or lateral aspects of the vertebral bodies, depending on the direction of insertion, so as not to protrude beyond the curved contours thereof. The present invention can benefit interbody spinal fusion implants having spaced apart non-arcuate opposed surfaces adapted to contact and support opposed adjacent vertebral bodies as well as implants having spaced apart arcuate opposed surfaces adapted to penetrably engage opposed vertebral bodies. As used herein, the term “arcuate” refers to the curved configuration of the opposed upper and lower portions of the implant transverse to the longitudinal axis of the implant along at least a portion of the implant's length.


In one embodiment of the present invention, an implant adapted for insertion from the posterior approach of the spine and for achieving better, safe filling of the posterior to anterior depth of the disc space between two adjacent vertebral bodies, and the possibility of having the leading end of the implant supported by the structurally superior more peripheral bone including the apophyseal rim and the bone adjacent to it, includes opposed portions adapted to be oriented toward the bone of the adjacent vertebral bodies, a leading end for inserting into the spine, and an opposite trailing end that may be adapted to cooperatively engage a driver. In the alternative, the implant may receive a portion of the driver through the trailing end to cooperatively engage the implant from within and/or at the implant trailing end. The leading end of this embodiment of the implant of the present invention is generally configured to conform to the natural anatomical curvature of the perimeter of the anterior aspect of the vertebral bodies, so that when the implant is fully inserted and properly seated within and across the disc space the implant contacts and supports a greater surface area of the vertebral bone in contact with the implant to provide all the previously identified advantages. Moreover, at the election of the surgeon, the implant of the present invention is configured to be able to be seated upon the more densely compacted bone about the periphery of the vertebral endplates for supporting the load through the implant when installed in or across the height of the intervertebral space.


Related art bone ring implants where the implant is a circle, oval, or oblong have trailing ends that are either modified to be squared-off, or unmodified so as to remain a portion of a circle, an oval, or an oblong and have a medial side wall that is incomplete due to a portion of the medullary canal interrupting the side wall. The present invention implants have an interior facing medial side wall adapted for placement medially within the disc space with the side wall intact and substantially in the same plane and an exterior facing lateral side wall opposite to the medial side wall adapted for placement laterally. The interior and exterior facing side wails have an inner surface facing each other. The implants of the present invention also may have a mid-longitudinal axis between the medial and lateral side wails wherein the mid-longitudinal axis at the leading end extends forward further than the lateral side wall at the leading end while the medial side wall is not equal in length to the lateral side wall, but is greater in length.


In another embodiment of the present invention, an implant for insertion from the anterior approach of the spine and for achieving better filling of the anterior to posterior depth of the disc space has a leading end generally configured to better conform to the natural anatomical curvature of the perimeter of the posterior aspect of the vertebral bodies and does not protrude laterally.


In yet another embodiment of the present invention, the implant has a trailing end that is either asymmetric or symmetric from side-to-side along the transverse axis of the implant. The trailing end may be adapted to conform to the anatomical contours of the anterior or posterior aspects of the vertebral bodies. For example, an implant for insertion from the posterior or anterior approach of the spine has a leading end that is generally configured to better conform to the natural anatomical curvature of at least one of the perimeter of the anterior and posterior aspects, respectively, of the vertebral bodies and a trailing end that is generally configured to conform to the natural anatomical curvature of the opposite one of the posterior and anterior aspects, respectively, of the vertebral bodies depending on the intended direction of insertion and that does not protrude laterally from the vertebral bodies. When the implant is fully seated and properly inserted within and across the disc space, the surface area of the vertebral bone in contact with the implant is more fully utilized.


As another example, an implant in accordance with the present invention for insertion from a translateral approach to the spine and across the transverse width of the vertebral bodies has a leading end that is generally configured to better conform to the natural anatomical curvature of the perimeter of at least one of the lateral aspects, respectively, of the vertebral bodies. The implant also may have a trailing end that is generally configured to conform to the natural anatomical curvature of the opposite one of the lateral aspects, respectively, of the vertebral bodies depending on the intended direction of insertion. Implants for insertion from a translateral approach and methods for inserting implants from a translateral approach are disclosed in Applicant's U.S. Pat. Nos. 5,860,973 and 5,772,661, respectively, incorporated by reference herein.


The implant of the present invention is better able to sit upon the dense compacted bone about the perimeter of the vertebral bodies of the vertebral endplate region for supporting the load through the implant when installed in the intervertebral space. Where the spinal implant of the present invention is an interbody spinal fusion implant then it also may have at least one opening therethrough from the upper vertebral body contacting surface through to the lower vertebral body contacting surface. The opening allows for communication between the opposed upper and lower vertebrae engaging surfaces to permit for growth of bone in continuity from adjacent vertebral body to adjacent vertebral body through the implant for fusion across the disc space.


For any of the embodiments of the present invention described herein, the implant preferably includes protrusions or surface roughenings for engaging the bone of the vertebral bodies adjacent to the implant. The material of the implant is an artificial material such as titanium or one of its implant quality alloys, cobalt chrome, tantalum, or any other metal appropriate for surgical implantation and use as an interbody spinal fusion implant, or ceramic, or composite including various plastics, carbon fiber composites, or coral, and can include artificial materials which are at least in part bioresorbable. The implants may further include osteogenic materials such as bone morphogenetic proteins, or other chemical compounds, or genetic material coding for the production of bone, the purpose of which is to induce or otherwise encourage the formation of bone or fusion.


Bone for use as the base material used to form the implant is specifically excluded from the definition of artificial materials for the purpose of this application. Where the implants are for spinal fusion, it is appreciated that they may be adapted to receive fusion promoting substances within them such as cancellous bone, bone derived products, or others.


It is appreciated that the features of the implant of the present invention as described herein are applicable to various embodiments of the present invention including implants having non-arcuate or arcuate upper and lower opposed portions adapted to be oriented toward the bone of the adjacent vertebral bodies.





BRIEF DESCRIPTION OF THE DRAWINGS


FIG. 1 is a top plan view of a horizontal cross-section through a boney endplate region of a vertebral body.



FIGS. 2-3 are top plan views of the fourth lumbar and first sacral vertebral bodies, respectively, in relationship to the blood vessels located anteriorly thereto.



FIG. 4 is a top plan plan view of an endplate region of a vertebral body with a prior art implant on the left side of the center line and an implant in accordance with one embodiment of the present invention on the right side of the centerline inserted from the posterior aspect of the spine.



FIG. 5 is a side perspective view of the outline of an implant in accordance with one embodiment of the present invention.



FIG. 5A is a side elevational view of an implant having a tapered leading end in accordance with an embodiment of the present invention.



FIG. 5B is a side elevational view of an implant having opposed portions that are generally in a converging relationship to each other from a trailing end to a leading end of the implant in accordance with an embodiment of the present invention.



FIG. 5C is a side elevational view of an implant having opposed portions that are generally in a diverging relationship to each other from a trailing end to a leading end of the implant in accordance with an embodiment of the present invention.



FIG. 6A is a partial enlarged fragmentary view along line 6A-6A of FIG. 5.



FIG. 6B is a partial enlarged fragmentary view along line 6B-6B of FIG. 5.



FIG. 7 is a top plan view of a lumbar vertebral body in relationship to the blood vessels located proximate thereto and an implant in accordance with one embodiment of the present invention inserted from the posterior aspect of the vertebral body.



FIG. 8 is a top plan view of a lumbar vertebral body in relationship to the blood vessels located proximate thereto and an implant in accordance with one embodiment of the present invention inserted from the anterior aspect of the vertebral body.



FIG. 9A is a top plan view of an implant in accordance with one embodiment of the present invention illustrating the mid-longitudinal axis and a plane bisecting the mid-longitudinal axis along the length of the implant.



FIG. 9B is a top plan view of an implant in accordance with another embodiment of the present invention illustrating the mid-longitudinal axis and a plane bisecting the mid-longitudinal axis along the length of the implant.



FIG. 10 is a top plan view of a lumbar vertebral body in relationship to the blood vessels located proximate thereto and an implant having arcuate upper and lower opposed portions in accordance with an embodiment of the present invention inserted from the posterior aspect of the vertebral body.



FIG. 11 is a trailing end view of a spinal implant shown in FIG. 10.





DETAILED DESCRIPTION OF THE INVENTION


FIG. 4 shows an embodiment of the present invention comprising an interbody spinal implant generally referred by the numeral 100, inserted in the direction of arrow P from the posterior aspect of a vertebral body V on one side of the centerline M in the lumbar spine. Implant 100 has a leading end 102 for insertion into the disc space and an opposite trailing end 104. In a preferred embodiment, leading end 102 is configured to not extend beyond the outer dimensions of the two vertebral bodies adjacent the disc space proximate leading end 102 after implant 100 is installed, to maximize the area of contact of the implant with the vertebral bone. Leading end 102 could be described as being generally configured to generally conform to at least a portion of the natural anatomical curvature of the aspect of the vertebral bodies adjacent the disc space proximate leading end 102 after implant 100 is installed. The general configuration of leading end 102 is further described in connection with FIGS. 9A and 9B below.


As shown in FIGS. 7 and 8, depending on the direction of insertion, for example, when implant 100 is installed in the direction of arrow P from the posterior aspect of the vertebral body V, leading end 102a is adapted to conform to at least a portion of the anterior aspect of the vertebral body V. When implant 100 is installed in the direction of arrow A from the anterior aspect of vertebral body V, leading end 102b is adapted to conform to at least a portion of the posterior aspect of vertebral body V. Trailing end 104 may be symmetrical or asymmetrical from side-to-side along the transverse axis of the implant and can conform to at least a portion of the natural curvature of the aspect of vertebral body V opposite to leading end 102. Trailing end 104 may or may not be configured to conform to the aspect of vertebral body V proximate trailing end 104 after implant 100 is installed. Trailing end 104 need only have a configuration suitable for its intended use in the spine.


As shown in FIGS. 5, 6A, and 6B, implant 100 has opposed portions 106 and 108 that are adapted to contact and support adjacent vertebral bodies when inserted across the intervertebral space. In this embodiment, opposed portions 106, 108 have a non-arcuate configuration transverse to the longitudinal axis of implant 100 along at least a portion of the length of implant 100. Opposed portions 106, 108 are spaced apart and connected by an interior side wall 112 and an exterior side wall 114 opposite interior side wall 112. Interior side wail 112 is the portion of implant 100 adapted to be placed toward another implant when implant 100 is inserted in pairs into the disc space between the adjacent vertebral bodies to be fused. Interior side wall 112 is not the internal surface of a hollow interior of implant 100. Exterior side wall 114 is adapted to be placed into the disc space nearer to the perimeter of the vertebral bodies than interior side wall 112. Side walls 112, 114 may also include at least one opening for permitting for the growth of bone therethrough.


Preferably, each of the opposed portions 106, 108 have at least one opening 110 in communication with one another to permit for the growth of bone in continuity from adjacent vertebral body to adjacent vertebral body and through implant 100. Implant 100 may further be hollow or at least in part hollow. Implant 100 may also include surface roughenings on for example, at least a portion of opposed portions 106, 108 for engaging the bone of the adjacent vertebral bodies.


In another preferred embodiment, the opposed portions of the implant can be in moveable relationship to each other to allow for relative motion of the adjacent vertebral bodies after the implant is installed.


As illustrated in FIG. 9A, implant 100 has a mid-longitudinal axis MLA along its length. Mid-longitudinal axis MLA is bisected by a plane BPP perpendicular to and bisecting the length of implant 100 along the mid-longitudinal axis MLA. Implant 100 has a first distance as measured from point C at leading end 102 to bisecting perpendicular plane BPP at point E that is greater than a second distance as measured from bisecting perpendicular plane BPP at point F to the junction of leading end 102 and exterior side wall 114 at point B. Implant 100 has a third distance as measured from point A at the junction of leading end 102 and interior side wail 112 to bisecting perpendicular plane BPP at point D that is greater than the second distance as measured from point F to point B. While in the preferred embodiment as shown in FIG. 9A, the third distance from points A to D is illustrated as being longer than the first distance from points C to E, the third distance can be equal to or less than the first distance, such as shown in FIG. 9B. In a preferred embodiment, the first distance measured from points C to E is greater than the second distance measured from points B to F; the third distance measured from points A to D can be less than the first distance measured from points C to E; and the third distance measured from points A to D does not equal the second distance measured from points B to F.


In a preferred embodiment of the present invention, when implant 100 is inserted between two adjacent vertebral bodies, implant 100 is contained completely within the vertebral bodies so as not to protrude from the spine. Specifically, the most lateral aspect of the implanted implant at the leading end has been relieved, foreshortened, or contoured so as to allow the remainder of the implant to be safely enlarged so as to be larger overall than the prior implants without the leading end lateral wall protruding from the disc space. Although overall enlargement of the implant is a preferred feature of one embodiment of the present invention, it is not a requisite element of the invention.


While a preferred embodiment of the present invention has been illustrated and described herein in the form of an implant having non-arcuate upper and lower portions along a portion of the length of the implant, another preferred embodiment of the present invention as best shown in FIG. 10 includes an implant having arcuate upper and lower portions along at least a portion of the length of the implant. All of the features described in association with the non-arcuate embodiments are equally applicable to the arcuate embodiments of the present invention.



FIGS. 10-11 show two interbody spinal implants generally referred to by the numeral 200, inserted in the direction of arrow P from the posterior aspect of a vertebral body V, one on either side of the centerline M in the lumbar spine. Implant 200 is non-threaded and is configured for linear insertion into the disc space in a direction along the mid-longitudinal axis of implant 200. Implant 200 has a leading end 202 for insertion into the disc space and an opposite trailing end 204. In a preferred embodiment, leading end 202 is configured to riot extend beyond the outer dimensions of the two vertebral bodies adjacent the disc space proximate leading end 202 after implant 200 is installed, to maximize the area of contact of the implant with the vertebral bone. Leading end 202 could be described as being generally configured to generally conform to at least a portion of the natural anatomical curvature of the aspect of the vertebral bodies adjacent the disc space proximate leading end 202 after implant 200 is installed. In a preferred embodiment, less than half of asymmetric leading end 202 is along a line perpendicular to the mid-longitudinal axis of the implant in a plane dividing the implant into an upper half and a lower half.


In a further preferred embodiment of either arcuate or non-arcuate implants, more than half of the leading end can be a contour that goes from the exterior side wall toward the mid-longitudinal axis of the implant in the plane dividing the implant into an upper half and a lower half. In another preferred embodiment of either arcuate or non-arcuate implants, the leading end includes a curve that extends from the exterior side wall beyond the mid-longitudinal axis of the implant. The more pronounced curve of the leading end of the implant of the present invention as compared to the chamfer of related art implants advantageously provides for closer placement of the implant's leading end to the perimeter of the vertebral body, without the limiting corner protruding therefrom, to more fully utilize the dense cortical bone in the perimeter of the vertebral bodies. The configuration of the implant of the present invention provides the use of an implant having a longer overall length as measured from leading end to trailing end for a better fill of the disc space. Implant 200 has opposed portions 206 and 208 that are arcuate transverse to the longitudinal axis of implant 200 along at least a portion of the length of implant 200 and are adapted to contact and support adjacent vertebral bodies when inserted across the intervertebral space and into the vertebral bodies. Implant 200 can further include protrusions or surface roughenings such as ratchetings 220 for enhancing stability. Surface roughenings may also include ridges, knurling and the like.


The present invention is not limited to use in the lumbar spine and is useful throughout the spine. In regard to use in the cervical spine, by way of example, in addition to various blood vessels the esophagus and trachea also should be avoided.


Further, the implant of the present invention preferably includes non-arcuate opposed surface portions that are either generally parallel to one another along the length of the implant or in angular relationship to each other such that the opposed surfaces are closer to each other proximate one end of the implant than at the longitudinally opposite other. For example, at least a portion of the opposed surfaces may be in a diverging relationship to each other from the trailing end to the leading end for allowing angulation of the adjacent vertebral bodies relative to each other. Alternatively, at least a portion of the opposed surfaces may be generally in a converging relationship to each other from the trailing end to the leading end for allowing angulation of the adjacent vertebral bodies relative to each other. The spinal implant of the present invention allows for a variable surface, or any other configuration and relationship of the opposed surfaces.


Implant 100 may be adapted to cooperatively engage a driver instrument for installation of the implant into the recipient site. For example, in a preferred embodiment trailing end 104 may be configured to complementary engage an instrument for driving implant 100.


While the exact contour and/or curvature of a particular vertebral body may not be known, the teaching of having the implant leading end be arcuate or truncated along one side (the lateral leading end) or from side to side so as to eliminate the length limiting lateral leading corner LC or the side wail or lateral aspect junction to the implant leading end is of such benefit that minor differences do not detract from its utility. Further, the range of describable curvatures may be varied proportionately with the size of the implants as well as their intended location within the spine and direction of insertion to be most appropriate and is easily determinable by those of ordinary skill in the art.


Generally for use in the lumbar spine, when the leading end of the implant is a portion of a circle then the arc of radius of the curvature of the leading end of the implant should be from 10-30 mm to be of greatest benefit, though it could be greater or less, and still be beneficial. The same is true for the cervical spine where the arc of radius is preferably 8-20 mm. While particular preferred embodiments of the present invention have been shown and described, it will be obvious to those skilled in the art that changes and modifications may be made without departing from this invention in its broader aspects.


While specific innovative features were presented in reference to specific examples, they are just examples, and it should be understood that various combinations of these innovative features beyond those specifically shown are taught such that they may now be easily alternatively combined and are hereby anticipated and claimed.

Claims
  • 1. An artificial interbody spinal implant for insertion at least in part across the surgically corrected height of a disc space between adjacent vertebral bodies of a human spine, the vertebral bodies having an anterior aspect and a posterior aspect, said implant comprising: a leading end for insertion first into the disc space, a trailing end opposite said leading end, and therebetween a length along a mid-longitudinal axis of said implant, said leading end being asymmetrical, and said leading end being at least in part curved in a plane dividing said implant into an upper half and a lower half;opposed portions between said leading and trailing ends adapted to be placed within the disc space to contact and support the adjacent vertebral bodies, said opposed portions being non-arcuate along at least a portion of the length of said implant, each of said opposed portions having at least one opening therein to permit for the growth of bone from adjacent vertebral body to adjacent vertebral body through said implant, said implant being formed at least in part of a material other than bone, said material comprising at least one of surgical quality titanium and its alloys, cobalt chrome alloy, tantalum, any metal or alloy suitable for the intended purpose, any ceramic material suitable for the intended purpose, and any plastic or composite material suitable for the intended purpose;an interior facing side wall, an exterior facing side wall opposite said interior facing side wall, and a width therebetween, said interior and exterior facing side walls extending between said opposed portions and having an inner surface facing each other, said exterior facing side wall including a straight portion along the length of said implant, said width of said implant being less than approximately one-half of the maximum width of the adjacent vertebral bodies into which said implant is adapted to be inserted, said interior and exterior facing side walls being between said opposed portions and said leading and trailing ends, said interior facing side wall adapted to be oriented toward another implant when inserted within the disc space, each of said opposed portions having a vertebral body contacting surface between said at least one opening and at least one of said interior side wall and said exterior side wall, each of said vertebral body contacting surfaces being adapted to be placed toward one of the adjacent vertebral bodies, said opposed portions being spaced apart and said inner surfaces of said interior and exterior facing side walls being spaced apart to define a hollow interior in communication with said openings, each of said at least one openings of said opposed portions having a mid-longitudinal axis and a maximum dimension in a plane perpendicular to the mid-longitudinal axis of each of said openings, said hollow interior having a maximum dimension between said inner surfaces of said interior and exterior facing side walls and in a plane perpendicular to the mid-longitudinal axis of said openings greater than said maximum dimension of said opening;a first distance as measured from an intersection of said leading end and the mid-longitudinal axis of said implant to an intersection of the mid-longitudinal axis of said implant and a plane perpendicular to and bisecting the length along the mid-longitudinal axis of said implant, said first distance being greater than a second distance as measured from an intersection of said perpendicular plane and said exterior side wall to a junction of said leading end and said exterior side wall; anda third distance as measured from a junction of said leading end and said interior side wall to an intersection of said interior side wall and said perpendicular plane, said third distance being greater than said second distance, said first distance being greater than said third distance.
  • 2. The implant of claim 1, wherein said leading end is at least in part non-linear.
  • 3. The implant of claim 1, in combination with a fusion promoting material.
  • 4. The implant of claim 1, further comprising at least one protrusion extending from at least one of said opposed portions for engaging at least one of the adjacent vertebral bodies to maintain said implant within the disc space.
  • 5. The implant of claim 1, wherein said implant has a maximum length less than and approximating the posterior to anterior depth of the vertebral body.
  • 6. The implant of claim 1, wherein at least a portion of said opposed portions are generally in a converging relationship to each other from trailing end to leading end for allowing angulation of the adjacent vertebral bodies relative to each other.
  • 7. The implant of claim 1, wherein said implant is adapted for insertion from the posterior aspect of the vertebral bodies and said leading end is configured to conform to the anatomic contour of at least a portion of the anterior aspect of the vertebral bodies.
  • 8. The implant of claim 1, wherein said implant is adapted for insertion from a lateral aspect of the vertebral bodies.
  • 9. The implant of claim 1, wherein said interior and exterior facing side walls are substantially parallel to one another along a majority of the length of said implant.
Parent Case Info

The present application is a continuation of U.S. application Ser. No. 12/315,991, filed Dec. 9, 2008; which is a continuation of U.S. application Ser. No. 09/553,573, filed Apr. 19, 2000 (now U.S. Pat. No. 7,462,195), all of which are incorporated herein by reference.

US Referenced Citations (191)
Number Name Date Kind
2677369 Knowles May 1954 A
3426364 Lumb Feb 1969 A
3848601 Ma et al. Nov 1974 A
3867728 Stubstad et al. Feb 1975 A
3875595 Froning Apr 1975 A
3905047 Long Sep 1975 A
D245259 Shen Aug 1977 S
4070514 Eatherly Jan 1978 A
4309777 Patil Jan 1982 A
4349921 Kuntz Sep 1982 A
4501269 Bagby Feb 1985 A
RE31865 Roux Apr 1985 E
4599086 Doty Jul 1986 A
4636217 Ogilvie et al. Jan 1987 A
4714469 Kenna Dec 1987 A
4743256 Brantigan May 1988 A
4759766 Buettner-Janz et al. Jul 1988 A
4759769 Hedman et al. Jul 1988 A
4820305 Harms et al. Apr 1989 A
4834757 Brantigan May 1989 A
4863476 Shepperd Sep 1989 A
4863477 Monson Sep 1989 A
4877020 Vich Oct 1989 A
4878915 Brantigan Nov 1989 A
4904261 Dove et al. Feb 1990 A
4911718 Lee et al. Mar 1990 A
4936848 Bagby Jun 1990 A
4955908 Frey et al. Sep 1990 A
4961740 Ray et al. Oct 1990 A
5015247 Michelson May 1991 A
5015255 Kuslich May 1991 A
5026373 Ray et al. Jun 1991 A
5047055 Bao Sep 1991 A
5055104 Ray Oct 1991 A
5059193 Kuslich Oct 1991 A
5062845 Kuslich et al. Nov 1991 A
5071437 Steffee Dec 1991 A
5122130 Keller Jun 1992 A
5123926 Pisharodi Jun 1992 A
5171278 Pisharodi Dec 1992 A
5192327 Brantigan Mar 1993 A
5246458 Graham Sep 1993 A
5258031 Salib et al. Nov 1993 A
5290312 Kojimoto et al. Mar 1994 A
5306308 Gross et al. Apr 1994 A
5306309 Wagner et al. Apr 1994 A
5370697 Baumgartner Dec 1994 A
5397364 Kozak et al. Mar 1995 A
5423855 Marienne Jun 1995 A
5425772 Brantigan Jun 1995 A
5443514 Steffee Aug 1995 A
5445639 Kuslich et al. Aug 1995 A
5458638 Kuslich et al. Oct 1995 A
5484437 Michelson Jan 1996 A
5489307 Kuslich et al. Feb 1996 A
5489308 Kuslich et al. Feb 1996 A
5507813 Dowd et al. Apr 1996 A
5522899 Michelson Jun 1996 A
5534031 Matsuzaki et al. Jul 1996 A
5571109 Bertagnoli Nov 1996 A
D377527 Michelson Jan 1997 S
5593409 Michelson Jan 1997 A
5607424 Tropiano Mar 1997 A
5609635 Michelson Mar 1997 A
5609636 Kohrs et al. Mar 1997 A
5645084 McKay Jul 1997 A
5645598 Brosnahan, III Jul 1997 A
5658337 Kohrs et al. Aug 1997 A
5669909 Zdeblick et al. Sep 1997 A
5683463 Godefroy et al. Nov 1997 A
5702449 McKay Dec 1997 A
5741253 Michelson Apr 1998 A
5766252 Henry et al. Jun 1998 A
5772661 Michelson Jun 1998 A
5776199 Michelson Jul 1998 A
5782919 Zdeblick et al. Jul 1998 A
D397439 Koros et al. Aug 1998 S
5800547 Scháfer et al. Sep 1998 A
5800550 Sertich Sep 1998 A
5814084 Grivas et al. Sep 1998 A
5846484 Scarborough et al. Dec 1998 A
5860973 Michelson Jan 1999 A
5861041 Tienboon Jan 1999 A
5865845 Thalgott Feb 1999 A
5888222 Coates et al. Mar 1999 A
5888226 Rogozinski Mar 1999 A
5888227 Cottle Mar 1999 A
5899939 Boyce et al. May 1999 A
5904719 Errico et al. May 1999 A
5906635 Maniglia May 1999 A
5972368 McKay Oct 1999 A
5989289 Coates et al. Nov 1999 A
6033438 Bianchi et al. Mar 2000 A
6034295 Rehberg et al. Mar 2000 A
6037519 McKay Mar 2000 A
6039762 McKay Mar 2000 A
D425989 Michelson May 2000 S
6080155 Michelson Jun 2000 A
6083228 Michelson Jul 2000 A
6111164 Rainey et al. Aug 2000 A
6113638 Williams et al. Sep 2000 A
6120503 Michelson Sep 2000 A
6136031 Middleton Oct 2000 A
6143032 Schafer Nov 2000 A
6159214 Michelson Dec 2000 A
6165219 Kohrs et al. Dec 2000 A
6174311 Branch et al. Jan 2001 B1
6179875 Von Strempel Jan 2001 B1
6200347 Anderson et al. Mar 2001 B1
6206922 Zdeblick et al. Mar 2001 B1
6206923 Boyd et al. Mar 2001 B1
6210412 Michelson Apr 2001 B1
6224607 Michelson May 2001 B1
6224631 Kohrs May 2001 B1
6231610 Geisler May 2001 B1
6241770 Michelson Jun 2001 B1
6241771 Gresser Jun 2001 B1
6245108 Biscup Jun 2001 B1
6258125 Paul et al. Jul 2001 B1
6261586 McKay Jul 2001 B1
6270528 McKay Aug 2001 B1
6277149 Boyle et al. Aug 2001 B1
6294041 Boyce et al. Sep 2001 B1
6294187 Boyce et al. Sep 2001 B1
6342074 Simpson Jan 2002 B1
6348071 Steffee et al. Feb 2002 B1
6350283 Michelson Feb 2002 B1
6371988 Pafford et al. Apr 2002 B1
6383221 Scarborough et al. May 2002 B1
6391058 Kuslich et al. May 2002 B1
6395031 Foley et al. May 2002 B1
6398811 McKay Jun 2002 B1
6402785 Zdeblick et al. Jun 2002 B1
6409765 Bianchi et al. Jun 2002 B1
6423095 Van Hoeck et al. Jul 2002 B1
6468311 Boyd et al. Oct 2002 B2
6471724 Zdeblick et al. Oct 2002 B2
6482233 Aebi et al. Nov 2002 B1
6482584 Mills et al. Nov 2002 B1
6485517 Michelson Nov 2002 B1
6511509 Ford et al. Jan 2003 B1
6530955 Boyle et al. Mar 2003 B2
6554863 Paul et al. Apr 2003 B2
6562072 Fuss et al. May 2003 B1
6562073 Foley May 2003 B2
6572654 Santilli Jun 2003 B1
6575981 Boyd et al. Jun 2003 B1
6610065 Branch et al. Aug 2003 B1
6629998 Lin Oct 2003 B1
6635086 Lin Oct 2003 B2
6666890 Michelson Dec 2003 B2
6706067 Shimp et al. Mar 2004 B2
6749636 Michelson Jun 2004 B2
6808585 Boyce et al. Oct 2004 B2
6827740 Michelson Dec 2004 B1
6855168 Crozet Feb 2005 B2
6890355 Michelson May 2005 B2
6923810 Michelson Aug 2005 B1
6984245 McGahan et al. Jan 2006 B2
6989031 Michelson Jan 2006 B2
7022137 Michelson Apr 2006 B2
7048762 Sander et al. May 2006 B1
7087082 Paul et al. Aug 2006 B2
7115146 Boyer Oct 2006 B2
7156875 Michelson Jan 2007 B2
7387643 Michelson Jun 2008 B2
7435262 Michelson Oct 2008 B2
7455692 Michelson Nov 2008 B2
7462195 Michelson Dec 2008 B1
7479160 Branch et al. Jan 2009 B2
7534254 Michelson May 2009 B1
7534265 Boyd et al. May 2009 B1
7540882 Michelson Jun 2009 B2
7611536 Michelson Nov 2009 B2
7637950 Baccelli et al. Dec 2009 B2
7637951 Michelson Dec 2009 B2
7637954 Michelson Dec 2009 B2
7935149 Michelson May 2011 B2
8137403 Michelson Mar 2012 B2
8292957 Michelson Oct 2012 B2
8323340 Michelson Dec 2012 B2
20010010020 Michelson Jul 2001 A1
20010018614 Bianchi Aug 2001 A1
20010031254 Bianchi et al. Oct 2001 A1
20020116065 Jackson Aug 2002 A1
20020193881 Shapiro et al. Dec 2002 A1
20040064185 Michelson Apr 2004 A1
20040210313 Michelson Oct 2004 A1
20050216089 Michelson Sep 2005 A1
20100145463 Michelson Jun 2010 A1
20110208313 Michelson Aug 2011 A1
Foreign Referenced Citations (38)
Number Date Country
35 05 567 May 1986 DE
0 077 159 Apr 1983 EP
0 179 695 Apr 1986 EP
0 260 044 Mar 1988 EP
0 307 241 Mar 1989 EP
0 392 076 Oct 1990 EP
0 577 179 Jan 1994 EP
0 599 419 Jun 1994 EP
0 627 204 Dec 1994 EP
0 637 440 Oct 1997 EP
0 834 295 Apr 1998 EP
283078 May 1985 ES
2 724 312 Mar 1993 FR
2 703 580 Oct 1994 FR
2 727 003 May 1996 FR
2 761 879 Oct 1998 FR
57-29348 Feb 1982 JP
61-122859 Jun 1986 JP
62-155846 Jul 1987 JP
5-269160 Oct 1993 JP
WO 9214423 Sep 1992 WO
WO 9301771 Feb 1993 WO
WO 9508306 Mar 1995 WO
WO 9508964 Apr 1995 WO
WO 9622747 Aug 1996 WO
WO 9640020 Dec 1996 WO
WO 9723174 Jul 1997 WO
WO 9723175 Jul 1997 WO
WO 9844877 Oct 1998 WO
WO 9848738 Nov 1998 WO
WO 9855052 Dec 1998 WO
WO 9963891 Dec 1999 WO
WO 0007527 Feb 2000 WO
WO 0074608 Dec 2000 WO
WO 0128465 Apr 2001 WO
WO 0168005 Apr 2001 WO
WO 0162191 Aug 2001 WO
WO 0168004 Sep 2001 WO
Non-Patent Literature Citations (25)
Entry
U.S. Appl. No. 60/115,388, filed Jan. 11, 1999; 80 pages.
U.S. Appl. No. 60/118,793, filed Feb. 4, 1999; 41 pages.
Muschier, George F., et al.; “The Biology of Spinal Fusion;” Spinal Fusion, Science and Technique, Colter and Colter; Dec. 1989; 2 cover pages and pp. 9-21.
Zindrick, Michael R., et al.; “Lumbar Spine Fusion: Different Types and Indications;” The Lumbar Spine, vol. 1, Second Edition; 1996; 2 cover pages and pp. 588-593.
Crock, H.V.; Practice of Spinal Surgery; Springer-Verlag/Wien, New York (1983).
DeBowes, R.M., et al., “Study of Bovine . . . Steel Baskets;” Transactions of the 29th Annual Meeting; Orthopaedic Research Society, vol. 8; Mar. 8-10, 1983; cover page and p. 407.
Otero-Vich, Jose M.; “Anterior Cervical Interbody Fusion with Threaded Cylindrical Bone;” J. Neurosurg, vol. 63; Nov. 1985; 2 cover pages and p. 750-753.
Butts, M.K., et al.; “Biomechanical Analysis of a New Method for Spinal Interbody Fixation,” 1987 Symposium, American Society of Mechanical Engineers, “Advances in Bioengineering”, Boston, MA; Dec. 13-18, 1987; 7 pages.
Crawley, Gregory R., et al.; “A Modified Cloward's Technique for Arthrodesis of the Normal Metacarpophalangeal Joint in the Horse;” Veterinary Surgery, vol. 17, No. 3; 1988; pp. 117-127.
Bagby, G.W.; Arthrodesis by the Distraction-Compression Method Using a Stainless Steel Implant; Orthopedics, vol. II, No. 6, pp. 931-34 (Jun. 1987).
Itoman, Moritoshi, et al.; “Banked Bone Grafting for Bone Defect Repair-Clinical Evaluation of Bone Union and Graft Incorporation;” J. Jpn. Orthop. Assoc., vol. 62; 1988; pp. 461-469.
Schmitz, H. J., et al.; “Performance of Alloplastic Materials and Design of an Artificial Disc;” The Artificial Disc; 1991; cover page and pp. 23-34.
Thieme; Fusion of the Lumbar Spine; “Anterior Monosegmental Fusion L5-S1;” Atlas of Spinal Operations; 1993; cover page and pp. 270-274.
White, et al.; Lumbar Spine Surgery, Techniques and Complications; History of Lumbar Spine Surgery; 1994; cover page and pp. 11-15, 27, 30, 35-45, 265-268.
European Opposition Document, Nov. 27, 1995—Opposing EP Patent No. 425 542 B1 Anterior Spinal Fusion Implant; 5 pages.
Laparoscopic Bone Dowel Surgical Technique; Brochure of Sofamor Danek; 1995; 17 pages.
Laparoscopic Bone Dowel Instruments; Brochure of Sofamor Danek; 1995; 2 pages.
Brochure of University of Florida Tissue Bank; MD-I and MD-II Custom Machine Cortical Dowels; Circa 1996; 2 pages.
Brochure of University of Florida Tissue Bank; MD-III Threaded Cortical Dowel; Circa 1996; 4 pages.
Glazer, P.A., et al.; Biomechanical Analysis of Multilevel Fixation Methods in the Lumbar Spine; Spine, vol. 22, No. 2, pp. 171-182 (1997).
Ray, C.D.; Spinal Interbody Fusions: A Review, Featuring New Generation Techniques; Neurosurgery Quarterly; 7(2):135-156 (1997).
A picture of a Medtronic, Sofamor Danek Display; titled “Evolving With Your Needs;” Apr. 6, 2000; 1 page.
RTI Precision Machined Allograft: The Surgeon's Choice, Brochure by Regeneration Technologies, Inc. (2000).
International Search Report mailed Aug. 14, 2000 from corresponding International PCT Application No. PCT/US00/12363, filed May 5, 2000; 1 page.
International Search Report mailed on Aug. 15, 2001, of corresponding International Application No. PCT/US01/11723, filed Apr. 19, 2001 3 pages.
Related Publications (1)
Number Date Country
20130096687 A1 Apr 2013 US
Continuations (2)
Number Date Country
Parent 12315991 Dec 2008 US
Child 13705036 US
Parent 09553573 Apr 2000 US
Child 12315991 US