IMPLANTS HAVING THREE DISTINCT SURFACES
An interbody spinal implant having at least three distinct surfaces including (1) at least one integration surface having a roughened surface topography including macro features, micro features, and nano features, without sharp teeth that risk damage to bone structures; (2) at least one graft contact surface having a coarse surface topography including micro features and nano features; and (3) at least one soft tissue surface having a substantially smooth surface including nano features. Also disclosed are processes of fabricating the different surface topographies, which may include separate macro processing, micro processing, and nano processing steps.
1 . An implant, comprising a body that is generally oval-shaped in transverse cross section and comprises a top surface, a bottom surface, opposing lateral sides, opposing anterior and posterior portions, a substantially hollow center, a sharp edge at the junction of the anterior portion and the top surface, a sharp edge at the junction of the anterior portion and the bottom surface, and a single vertical aperture extending from the top surface to the bottom surface, having maximum width at its center, and defining a transverse rim on the top surface and on the bottom surface, said transverse rim having variable width or thickness and at least a portion with an integration surface comprising macro features, micro features, and nano features, wherein the opposing lateral sides and the opposing anterior and posterior portions include a substantially smooth surface comprising nano features.
2 . The implant of claim 1 , wherein the body comprises a metal.
3 . The implant of claim 2 , wherein the metal comprises titanium or an alloy thereof.
4 . The implant of claim 1 , wherein the posterior portion comprises a generally tapered nose.
5 . The implant of claim 1 , wherein the junction of the posterior portion and the top surface, and the junction of the posterior portion and the bottom surface comprises a blunt and radiused surface without the integration surface.
6 . The implant of claim 1 , wherein the body comprises at least one transverse aperture extending through each of the opposing lateral sides and which is in communication with the substantially hollow center.
7 . The implant of claim 1 , wherein the body comprises a lordotic angle.
8 . The implant of claim 1 , wherein the anterior portion comprises at least one opening extending through the anterior portion and which is in communication with the substantially hollow center.
9 . The implant of claim 1 , wherein the single vertical aperture is surrounded by internal surfaces of the body comprising a first graft contact surface comprising micro features and nano features.
10 . The interbody spinal implant of claim 1 , wherein the integration surface comprises a roughness average amplitude, Ra, of about 8 to 200 microns, and the substantially smooth surface comprises a roughness average amplitude, Ra, of about 0.01 to 2 microns.
11 . The implant of claim 1 , wherein the macro features have a mean spacing between about 400 to 2000 microns, a maximum peak-to-valley height between about 40 to 500 microns, and an average amplitude between about 20 to 200 microns; the micro features have a mean spacing between about 20 to 400 microns, a maximum peak-to-valley height between about 2 to 40 microns, and an average amplitude between about 1 to 20 microns; and each of the nano features have a mean spacing between about 0.5 to 20 microns, a maximum peak-to-valley height between about 0.2 to 2 microns, and an average amplitude between about 0.1 to 1 microns.
12 . The implant of claim 1 , wherein the macro features have a mean spacing between about 750 to 1750 microns, a maximum peak-to-valley height between about 150 to 400 microns, and an average amplitude between about 50 to 150 microns; the micro features have a mean spacing between about 100 to 300 microns, a maximum peak-to-valley height between about 2 to 20 microns, and an average amplitude between about 4 to 10 microns; and each of the nano features have a mean spacing between about 1 to 15 microns, a maximum peak-to-valley height between about 0.2 to 1.8 microns, and an average amplitude between about 0.01 to 1 microns.
13 . The implant of claim 1 , wherein the macro features have a mean spacing between about 1000 to 1500 microns, a maximum peak-to-valley height between about 250 to 300 microns, and an average amplitude between about 100 to 125 microns; the micro features have a mean spacing between about 200 to 250 microns, a maximum peak-to-valley height between about 9 to 13 microns, and an average amplitude between about 2 to 6 microns; and each of the nano features have a mean spacing between about 5 to 12 microns, a maximum peak-to-valley height between about 0.3 to 1.3 microns, and an average amplitude between about 0.03 to 0.06 microns.
14 . The interbody spinal implant of claim 9 , wherein the substantially hollow center is surrounded by internal surfaces of the body comprising a second graft contact surface comprising micro features and nano features.
15 . The implant of claim 14 , wherein each of the micro features of the second graft contact surface have a mean spacing between about 20 to 400 microns, a maximum peak-to-valley height between about 2 to 40 microns, and an average amplitude between about 1 to 20 microns, and each of the nano features of the second graft contact surface have a mean spacing between about 0.5 to 20 microns, a maximum peak-to-valley height between about 0.2 to 2 microns, and an average amplitude between about 0.1 to 1 microns.
16 . The implant of claim 14 , wherein each of the micro features of the second graft contact surface have a mean spacing between about 100 to 300 microns, a maximum peak-to-valley height between about 2 to 20 microns, and an average amplitude between about 4 to 10 microns, and each of the nano features of the second graft contact surface have a mean spacing between about 1 to 15 microns, a maximum peak-to-valley height between about 0.2 to 1.8 microns, and an average amplitude between about 0.01 to 1 microns.
17 . The implant of claim 14 , wherein each of the micro features of the second graft contact surface have a mean spacing between about 200 to 250 microns, a maximum peak-to-valley height between about 9 to 13 microns, and an average amplitude between about 2 to 6 microns; and each of the nano features of the second graft contact surface have a mean spacing between about 5 to 12 microns, a maximum peak-to-valley height between about 0.3 to 1.3 microns, and an average amplitude between about 0.03 to 0.06 microns.
18 . An implant, comprising a body that is generally rectangular-shaped in transverse cross section and comprises a top surface, a bottom surface, opposing lateral sides, opposing anterior and posterior portions, a substantially hollow center, a sharp edge on the top surface and on the bottom surface for digging into vertebral end plate bone and resisting expulsion of the implant from the intervertebral space, and a single vertical aperture extending from the top surface to the bottom surface, having maximum width at its center, and defining a transverse rim on the top surface and on the bottom surface, said transverse rim having variable width or thickness and at least a portion with an integration surface comprising macro features, micro features, and nano features, wherein the opposing lateral sides and the opposing anterior and posterior portions include a substantially smooth surface comprising nano features.
19 . The implant of claim 18 , wherein the body comprises a metal.
20 . The implant of claim 19 , wherein the metal comprises titanium or an alloy thereof.
21 . The implant of claim 18 , wherein the junction of the posterior portion and the lateral sides is rounded.
22 . The implant of claim 18 , wherein the body comprises at least one transverse aperture extending through each of the opposing lateral sides and which is in communication with the substantially hollow center.
23 . The implant of claim 18 , wherein the body comprises a lordotic angle.
24 . The implant of claim 18 , wherein the single vertical aperture is surrounded by internal surfaces of the body comprising a first graft contact surface comprising micro features and nano features.
25 . The interbody spinal implant of claim 18 , wherein the integration surface comprises a roughness average amplitude, Ra, of about 8 to 200 microns, and the substantially smooth surface comprises a roughness average amplitude, Ra, of about 0.01 to 2 microns.
26 . The implant of claim 18 , wherein the macro features have a mean spacing between about 400 to 2000 microns, a maximum peak-to-valley height between about 40 to 500 microns, and an average amplitude between about 20 to 200 microns; the micro features have a mean spacing between about 20 to 400 microns, a maximum peak-to-valley height between about 2 to 40 microns, and an average amplitude between about 1 to 20 microns; and each of the nano features have a mean spacing between about 0.5 to 20 microns, a maximum peak-to-valley height between about 0.2 to 2 microns, and an average amplitude between about 0.1 to 1 microns.
27 . The implant of claim 18 , wherein the macro features have a mean spacing between about 750 to 1750 microns, a maximum peak-to-valley height between about 150 to 400 microns, and an average amplitude between about 50 to 150 microns; the micro features have a mean spacing between about 100 to 300 microns, a maximum peak-to-valley height between about 2 to 20 microns, and an average amplitude between about 4 to 10 microns; and each of the nano features have a mean spacing between about 1 to 15 microns, a maximum peak-to-valley height between about 0.2 to 1.8 microns, and an average amplitude between about 0.01 to 1 microns.
28 . The implant of claim 18 , wherein the macro features have a mean spacing between about 1000 to 1500 microns, a maximum peak-to-valley height between about 250 to 300 microns, and an average amplitude between about 100 to 125 microns; the micro features have a mean spacing between about 200 to 250 microns, a maximum peak-to-valley height between about 9 to 13 microns, and an average amplitude between about 2 to 6 microns; and each of the nano features have a mean spacing between about 5 to 12 microns, a maximum peak-to-valley height between about 0.3 to 1.3 microns, and an average amplitude between about 0.03 to 0.06 microns.
29 . The interbody spinal implant of claim 24 , wherein the substantially hollow center is surrounded by internal surfaces of the body comprising a second graft contact surface comprising micro features and nano features.
30 . The implant of claim 29 , wherein each of the micro features of the second graft contact surface have a mean spacing between about 20 to 400 microns, a maximum peak-to-valley height between about 2 to 40 microns, and an average amplitude between about 1 to 20 microns, and each of the nano features of the second graft contact surface have a mean spacing between about 0.5 to 20 microns, a maximum peak-to-valley height between about 0.2 to 2 microns, and an average amplitude between about 0.1 to 1 microns.
31 . The implant of claim 29 , wherein each of the micro features of the second graft contact surface have a mean spacing between about 100 to 300 microns, a maximum peak-to-valley height between about 2 to 20 microns, and an average amplitude between about 4 to 10 microns, and each of the nano features of the second graft contact surface have a mean spacing between about 1 to 15 microns, a maximum peak-to-valley height between about 0.2 to 1.8 microns, and an average amplitude between about 0.01 to 1 microns.
32 . The implant of claim 29 , wherein each of the micro features of the second graft contact surface have a mean spacing between about 200 to 250 microns, a maximum peak-to-valley height between about 9 to 13 microns, and an average amplitude between about 2 to 6 microns; and each of the nano features of the second graft contact surface have a mean spacing between about 5 to 12 microns, a maximum peak-to-valley height between about 0.3 to 1.3 microns, and an average amplitude between about 0.03 to 0.06 microns.