BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be better understood when consideration is given to the following detailed description thereof. Such description makes reference to the annexed drawings wherein:
FIG. 1 is a side view of the teeth of a prior art implant;
FIG. 2 is a perspective view of a prior art implant with pyramidal teeth;
FIG. 3 is a perspective view of one embodiment of the intervertebral fusion device of the present invention;
FIG. 4 is a top view of one embodiment of the intervertebral fusion device of the present invention;
FIG. 5 is a side view of one embodiment of the intervertebral fusion device of the present invention;
FIG. 6 is a side view one embodiment of the intervertebral fusion device of the present invention with details A and B;
FIG. 7 is a side view of detail A from FIG. 6;
FIG. 8 is a side view of detail B from FIG. 6;
FIG. 9 is a set of bones that are used in the fabrication of the intervertebral fusion device of the present invention;
FIG. 10 is a schematic diagram depicting the footings and grooves of the implantable intervertebral fusion device of the present invention;
FIG. 11 is a schematic diagram depicting a set of lateral guides of the implantable intervertebral fusion device of the present invention;
FIG. 12 is a schematic diagram of one embodiment of the surgical instrument for implanting intervertebral fusion device of the present invention;
FIG. 13 depicts the wedge shaped profile of the intervertebral fusion device of the present invention;
FIG. 14 depicts an anterior lumbar interbody fusion (ALIF) surgery for the implantation of the intervertebral fusion device of the present invention;
FIG. 15 depicts the fusion of the new bone after the implantation of the intervertebral fusion device of the present invention has taken place;
FIG. 16 depicts a side schematic view of another embodiment of the intervertebral fusion device of the present invention; and
FIGS. 17A, 17B, and 17C are various configurations of footings that can be used in the present invention.
DETAILED DESCRIPTION
The present invention relates to an implantable intervertebral fusion device for use when surgical fusion of vertebral bodies is indicated. The implant is comprised of an allogenic cortical bone conforming in size and shape with the end plates of the adjacent vertebrae and has a wedge-shaped profile with a plurality of footings and grooves located on the top and bottom surfaces.
The top and bottom surface of the implant has a macro-texture and a micro-texture. The macro-structure is formed by a series of continuous footings and grooves that cross the implant from side to side. The relative placement of each footing and groove defines a surface upon which an osteoconductive and/or osteoinductive micro-structure may be applied. The top surface of the implantable device is a convex surface with its apex at the back of the implant and the bottom surface is flat planar surface or curved surface to match the topography of the end plate.
The lateral corners of the implantable device are rounded or chamfered in order to adapt anatomically to the vertebrae endplates curvature. The back of the device is rounded or chamfered in order to facilitate insertion of the implant. In one embodiment, the implant has a lateral guide or groove on at least one side for receiving a surgical instrument for implantation. The guide or groove runs in lateral direction to accommodate a variety of surgical approaches. In another embodiment, resorbable and/or nonresorbable fixation devices, such as screws, could be placed on the endplates in front of the implant to improve initial fixation.
Referring to FIG. 3, a top view of the first embodiment of the intervertebral fusion device according to the present invention is depicted. The intervertebral fusion device 300 conforms in size and shape with the end plates of the adjacent vertebrae between which the device 300 is to be implanted. The device 300 is made of an allograft material which helps in the formation of new bone to fuse the two vertebral bodies together. In one embodiment, the intervertebral fusion device 300 is used as an implant deployed in an Anterior Lumbar Interbody Fusion (ALIF) procedure. In another embodiment, the intervertebral fusion device 300 is used as an implant deployed in a Posterior Lumbar Interbody Fusion (PLIF) procedure. In yet another embodiment, the intervertebral fusion device 300 is used as an implant deployed in an Anterior Cervical Fusion (ACF) procedure. In yet another embodiment, the intervertebral fusion device 300 is used as an implant deployed in a Transforaminal Lumbar Interbody Fusion (TLIF) procedure. The intervertebral fusion device can be used in any region of the spine.
Referring to FIG. 9, a set of bones that are used in the fabrication of the abovementioned intervertebral fusion device is depicted. The bones can be from any source, including animals such as cows or pigs, e.g. xenograft bone. In one embodiment, the intervertebral fusion device is made of allogenic cortical bone received from human long bones. The pieces of these cortical long bones 900 are cut perpendicular 902 to the bone axis and the marrow is removed to obtain annular shapes. The annular rings are then machined using appropriate equipment, known to persons of ordinary skill in the art, and are finally cleaned for implantation.
Referring back to FIG. 3, the intervertebral fusion device 300 comprises a macro-structure 302 and a micro structure 303. The macro-structure 302 further comprises a plurality of footings 304, 305 and grooves 306, 307 that cross the intervertebral fusion device 300 from side to side. FIG. 4 depicts the general ring structure of the intervertebral fusion device. In one embodiment, the dimensions 410, 420, 415 can be of any size that would be appropriate for use in ACF, ALIF, and PLIF procedures. In another embodiment, dimensions 410, 420 range from 2 mm to 6 mm, preferably 4 mm, and dimension 415 ranges from 2 mm to 8 mm, preferably 6 mm.
Referring to FIG. 5, an implant 500 is shown. The implant 500 comprises a body 520 having a guide 515, a top surface 530, and a bottom surface 540. Optionally, at least one of the top or bottom surface comprises a convex depression 510 and a plurality of footings 505 and grooves 506 that form a macro-structure for enabling adhesion between the implant and surrounding bone. An osteoconductive and/or osteoinductive micro-structure, not shown, can be applied between the footings.
FIGS. 6-8 and 10 disclose a plurality of exemplary embodiments of the macro-structure. FIG. 6 depicts an implant structure 600 having a macrostructure 635 which is more particularly shown in details A and B provided in FIGS. 7 and 8 respectively.
The implant structure can be described by a plurality of dimensions, namely the distance between the highest portion of the top surface and the lowest portion of the top surface 640; the anterior height 645; the anterior-posterior depth of the implant 605; the distance between footings 665; the roughness of the microtexture coating 665; the distance between the bottom surface and surgical instrument groove 655; the dome radius of certain structures 615, 625, 635 and the medio-lateral width (not shown). However, it should be appreciated that the values for these dimensions are not limiting and are provided as an enabling examples of how an implant could be practiced.
In one embodiment, an ALIF implant is designed with a distance of 2-6 mm between the highest portion of the top surface and the lowest portion of the top surface 640, which defines a lordosis angle of 5 to 13 degrees; a distance of 9-21 mm for the anterior height 645; a distance of 21-28 mm for the anterior-posterior depth of the implant 605; a distance of 2-6 mm between footings 665; a roughness of 100 to 250 microns for the microtexture coating 665; a distance of 3 mm to 9 mm between the bottom surface and surgical instrument groove 655; a dome radius of 0.1-2 mm, 20-40 mm, and for 80-110 mm for structures 625, 615, 635 respectively; and a distance of 24-32 mm for the medio-lateral width (not shown). The instrument groove can be defined as having a width no greater than one-third of the implant anterior height, which would yield a depth range of 3 mm to 7 mm in this example, and a depth no greater than a value which would leave the minimum implant wall thickness as at least 3 mm.
In one embodiment, a PLIF implant is designed with a distance of 0-3 mm between the highest portion of the top surface and the lowest portion of the top surface 640, which defines a lordosis angle of 0 to 7 degrees; a distance of 7-16 mm for the anterior height 645; a distance of 20-26 mm for the anterior-posterior depth of the implant 605; a distance of 2-6 mm between footings 665; a roughness of 100 to 250 microns for the microtexture coating 665; a distance of 3 mm to 9 mm between the bottom surface and surgical instrument groove 655; a dome radius of 0.1-2 mm, 20-40 mm, and for 80-110 mm for structures 625, 615, 635 respectively; and a distance of 7-11 mm for the medio-lateral width (not shown). The instrument groove can be defined as having a width no greater than one-third of the implant anterior height, which would yield a depth range of 2.33 mm to 5.33 mm in this example, and a depth no greater than a value which would leave the minimum implant wall thickness as at least 3 mm.
In one embodiment, an ACF implant is designed with a distance of 0-5 mm between the highest portion of the top surface and the lowest portion of the top surface 640, which defines a lordosis angle of 0 to 10 degrees; a distance of 4.5-12 mm for the anterior height 645; a distance of 10-14 mm for the anterior-posterior depth of the implant 605; a distance of 2-4 mm between footings 665; a roughness of 100 to 250 microns for the microtexture coating 665; a distance of 3 mm to 9 mm between the bottom surface and surgical instrument groove 655; a dome radius of 0.1-2 mm, 20-40 mm, and for 80-110 mm for structures 625, 615, 635 respectively; and a distance of 9-16 mm for the medio-lateral width (not shown). The instrument groove can be defined as having a width no greater than one-third of the implant anterior height, which would yield a depth range of 1.5 mm to 4 mm in this example, and a depth no greater than a value which would leave the minimum implant wall thickness as at least 3 mm.
Regardless of dimensions used, every adjacent footing 304 and groove 305 defines an area upon which an osteoconductive and/or osteoinductive micro-structure can be applied. The micro-structure preferably has a roughness of the order of 100-250 micrometer, although other roughness ranges, such as 50 to 1000 microns, may be employed. This microstructure helps improve the initial stability of the intervertebral fusion device due to increased friction. The osteoconductive and/or oasteoinductive nature of the microtexture helps in the promotion of bone apposition. In one embodiment, the microtexture comprises the coating described in U.S. Pat. No. 4,206,516, which is incorporated herein by reference. In another embodiment, the microtexture comprises the coating described in U.S. Pat. No. 4,865,603, which is also incorporated herein by reference. In one embodiment, the micro-structure mimics cancellous bone architecture.
Now referring to FIGS. 7 and 8, the diagram depicts the footings and groove of the abovementioned implantable intervertebral fusion device. The footings 740, 750, 840, 850 have sharp protrusions which assist in the penetration of the intervertebral fusion device into the vertebras endplates and helps in the initial fixation of the implant. The initial mechanical stability attained by the footings 740, 750, 840, 850 minimizes the risk of post-operative expulsion of the implant. The grooves 705, 706, 805, 806 adjacent to the footings 740, 750, 840, 850 provide the long term fixation, after bone ingrowth happens in the grooves 705, 706, 805, 806. The footings 740, 750, 840, 850 in unison with the grooves 705, 706, 805, 806 provide mechanical interlocks between the intervertebral fusion device and the endplates of the vertebrae. In one embodiment of the present invention, by fixing a minimum separation between the footings 740, 750, 840, 850 the number of footings on the surface of the implant is reduced. Therefore, the points of contact with the endplates are also reduced which enables higher penetration of the footings 740, 750, 840, 850 into the endplates of the vertebrae.
In one embodiment, the footings 740, 840 have triangular protrusions with tips defined by angle 815 of 35 to 45 degrees. In another embodiment, the footings 740, 840 have a height 720 of 0.3 to 0.7 mm. In another embodiment, the footings 750, 850 comprise a first portion with a minimum predefined elevation 730 above the groove. In another embodiment, the footings 750, 850 have a second portion with a minimum predefined elevation 830 and a triangular protrusion with a tip defined as being in the range 715 of 35 to 45 degrees. It should be appreciated that, relative to the face of the implant, the footing protrusions are at right angles or tilted forward to ensure the implant resists expulsion by the vertebrae. This geometry of the teeth helps in preventing movement toward the front of the implant.
In another embodiment, the footing is an elevated structure with a sharp portion thereto and defined by at least one angle 715, 815 in the range of 15 to 65 degrees. Referring to FIGS. 17A to 17B, alternative footing designs are shown. In one embodiment, shown in FIG. 17A, a first footing 1701A has a triangular shape at an angle of less than 90 degrees relative to the groove surface 1702A. Groove 1702A separates the first footing 1701A from a second footing 1703A. The second footing 1703A has a protrusion with a face 1704A forming an angle of more than 135 degrees relative to the groove surface. In another embodiment, shown in FIG. 17B, a first footing 1701B has a triangular shape at a right angle relative to the groove surface 1702B. Groove 1702B separates the first footing 1701B from a second footing 1703B. The second footing 1703B has a protrusion with a face 1704B forming an angle of approximately 145 degrees relative to the groove surface 1702B.
In another embodiment, at least one footing is in the shape of a pyramid and are right triangles with the opposite angles at 45° and its hypotenuse facing the back of the implant. In another embodiment, the footing 1701C has a triangular shape, shown in FIG. 17C. Alternatively, footings may have a saw tooth shape with the saw tooth running in the anterior-posterior direction. For any given implant, the number of footings can be in the range of 4 to 8, although there is no limitation on the specific number of footings per implant.
It should be appreciated that, in one embodiment, the footings are designed to structurally degenerate, i.e. crumble, after implant insertion, thereby increasing the surface area for fusion.
Referring to FIG. 11, a first lateral guide and the second lateral guide of the abovementioned implantable intervertebral fusion device is depicted. The first lateral guide 1101 and the second lateral guide 1102 are sized to receive surgical instrument such as an inserter for implantation of implant. The first 1101 and second lateral guides 1102 can be of any geometric shape. In one embodiment, they are rectangular. In another embodiment, the lateral guides 1101, 1102 are 1 mm deep and 3 mm wide. In another embodiment, the lateral guides 1101, 1102 are of any size that allows an intervertebral fusion device to be grasped by the implantation instrument.
Referring to FIG. 5, one embodiment of the implantation instrument for implanting the above-mentioned intervertebral fusion device is depicted. The instrument comprises of handles 501, 502, and a set of two hooks 503, 504 at the extreme end for grasping the lateral guides. Once the surgeon is able to grip the lateral guides of the implant, the placement of the implant in the spinal column is carried out. In one embodiment, resorbable screws could be placed on the endplates in front of the implant to improve initial fixation.
The dimensions of implant can be varied to accommodate a patient's anatomy. However, the intervertebral fusion device of the present invention is preferably wide enough to support adjacent vertebrae and is of sufficient height to separate the adjacent vertebrae.
In one embodiment, a smaller implant would have a width of 27 mm and the front to back length of 25 mm and a larger implant would preferably have a width of 32 mm and front to back length of 28 mm. The size of the implant allows implants to be implanted using conventional open surgical procedures or minimally invasive procedures, such as laparoscopic surgery or an ALIF procedure. This minimizes muscle stripping, scar tissue in the canal, and nerve root retraction and handling. In addition, because the width is kept to a restricted size range and does not necessarily increase with implant height, taller implants can be used without requiring wider implants. Thus, facet removal and retraction of nerve roots can remain minimal.
In order to restore the natural curvature of the spine after the affected disc has been removed, the intervertebral fusion device of the present invention has a wedge-shaped profile.
Now referring to FIG. 6, one embodiment of the wedge shape profile of the intervertebral fusion device of the present invention is depicted. The wedge shape 601 of the device results from a gradual decrease in the height from the front side to the back side. Thus, when implant is employed in the lumbar region, in one embodiment, the angle 602 formed by the wedge is preferably between 7° to 9°, so that the wedge shape can mimic the anatomy of the lumbar spine and it can adapt anatomically to the curvature of the endplates of the lumbar vertebras.
In addition, to facilitate the insertion of implant and to adapt anatomically to the curvature of the vertebrae endplates, the lateral corners of the device are rounded or chamfered. The rounded or chamfered edges enable the intervertebral fusion device to slide between the endplates while minimizing the necessary distraction of the endplates.
Referring to FIG. 7, an anterior lumbar interbody fusion surgery for the implantation of intervertebral fusion device of the present invention is depicted. The retroperitoneal approach for an ALIF procedure involves an incision 701 on the left side of the abdomen 702 and the abdominal muscles are retracted to the side. Since the anterior abdominal muscle in the midline (rectus abdominis) runs vertically, it does not need to be cut and easily retracts to the side. The abdominal contents lay inside a large sack (peritoneum) that can also be retracted, thus allowing the spine surgeon to access the front of the spine for implantation. In an alternate embodiment, endoscope procedure which involves surgery via several incisions can also be performed.
Although the intervertebral fusion device is a solid piece of allogenic cortical bone, the device can be provided with a hollow interior to form an interior space. This interior space can be filled with bone chips or any other osteoconductive surfacing or surface treatment, osteoinductive or any other bone growth stimulation coating material to further promote the formation of new bone. For example, FIG. 8 depicts the fusion of the new bone with the adjacent vertebrae after the implantation of intervertebral fusion device has taken place. The intervertebral fusion device 801 is sandwiched between the adjacent vertebrae 802, 803 and the gradual bone in-growth takes place initially into the grooves of the device, and ultimately replaces the allograft bone structure.
Referring to FIG. 9, a top view of another embodiment of the intervertebral fusion device of the present invention is depicted. In situations, where it is difficult to obtain a single section of allogenic bone from which the implant is to be made, fabricating implant in two pieces, i.e. top 901 and bottom portions 902, allows smaller sections of allogenic cortical bone to be used. A top connecting surface 903 and a bottom connecting surface 904 define the interface between the top 901 and bottom 902 portions.
As shown in the FIG. 9, the top 901 and bottom 902 surfaces, have ridges 905 that mate with the grooves 906 to interlock the top and bottom portions 901, 902. Preferably, ridges 905 and grooves 906 are formed by milling top and bottom surfaces 903, 904 in a first direction and then milling a second time with top and bottom surfaces 903, 904 oriented with respect to the first direction. A pin 907 passing through aligned holes in top and bottom portions 901, 902 serves to retain top and bottom portions 901, 902 together. Although pin 906 can be made of any biocompatible material, pin 906 is preferably made of an allogenic bone. The number and orientation of pins 906 can be varied.
The above examples are merely illustrative of the many applications of the system of present invention. Although only a few embodiments of the present invention have been described herein, it should be understood that the present invention might be embodied in many other specific forms without departing from the spirit or scope of the invention. Therefore, the present examples and embodiments are to be considered as illustrative and not restrictive, and the invention is not to be limited to the details given herein, but may be modified within the scope of the appended claims.
Patent Application
20080097610
