Process of fabricating implants having three distinct surfaces

Abstract

Processes of fabricating different surface topographies, which may include separate macro processing, micro processing, and nano processing steps, in order to produce 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.

What is claimed is: 
     
         1 . A process of fabricating a predetermined surface topography on at least one surface of an implant, the process comprising:
 macro processing at least one integration surface adapted to be in contact with adjacent vertebral endplates,   micro processing the at least one integration surface and at least one graft contact surface adapted to be in contact with a bone growth inducing material, and   nano processing the at least one integration surface, the at least one graft contact surface, and at least one soft tissue surface which may be in contact with bone or soft tissue during or after implantation.   
     
     
         2 . The process of  claim 1 , wherein the macro processing includes heavy mechanical or chemical bulk removal of at least a portion of the at least one integration surface; the micro processing includes mechanical or chemical removal of at least a portion of the at least one integration surface and the at least one graft contact surface; and the nano processing includes mild chemical etching, laser or other directed energy material removal, abrasion, blasting, or tumbling, followed by cleaning of at least a portion of the at least one integration surface, the at least one graft contact surface, and the at least one soft tissue surface. 
     
     
         3 . The process of  claim 1 , wherein the nano processing comprises:
 preparing an acid solution comprising hydrochloric acid, water, and titanium;   applying the acid solution to at least one of the at least one integration surface, the at least one graft contact surface, and the at least one soft tissue surface;   removing the acid solution by rinsing with water; and   heating and subsequently cooling the at least one surface.   
     
     
         4 . The process of  claim 3 , wherein the acid solution comprises a concentration of 25-31% hydrochloric acid. 
     
     
         5 . The process of  claim 3 , wherein the titanium is seeded in the acid solution or is present from titanium previously removed from at least one surface of the implant. 
     
     
         6 . The process of  claim 3 , wherein the acid solution is heated to a temperature of about 200-210° F. when applied, and the acid solution is applied to the at least one surface for a period of time of about 15-25 minutes. 
     
     
         7 . The process of  claim 1 , further comprising an initial step of providing the implant, wherein the implant has:
 a body having a top surface, a bottom surface, opposing lateral sides, opposing anterior and posterior portions, a substantially hollow center, and a single vertical aperture; and   optionally, at least one of a first integration plate affixed to the top surface of the body and a second integration plate affixed to the bottom surface of the body, wherein the first integration plate and the second integration plate each have a top surface, a bottom surface, opposing lateral sides, opposing anterior and posterior portions, and a single vertical aperture extending from the top surface to the bottom surface and aligning with the single vertical aperture of the body,   wherein the at least one integration surface comprises at least one of the top surface of the body, the bottom surface of the body, the top surface of the first integration plate, and the top surface of the second integration plate.   
     
     
         8 . The process of  claim 1 , further comprising an initial step of providing the implant, wherein the implant has:
 a body having a top surface, a bottom surface, opposing lateral sides, opposing anterior and posterior portions, a substantially hollow center, a single vertical aperture defining at least one surface, optionally a transverse aperture defining at least one surface, and optionally an opening defining at least one surface; and   optionally, at least one of a first integration plate affixed to the top surface of the body and a second integration plate affixed to the bottom surface of the body, wherein the first integration plate and the second integration plate each have a top surface, a bottom surface, opposing lateral sides, opposing anterior and posterior portions, and a single vertical aperture extending from the top surface to the bottom surface and aligning with the single vertical aperture of the body,   wherein the at least one graft contact surface comprises at least one of the surfaces defined by the single vertical aperture, the optional transverse aperture, and the optional opening.   
     
     
         9 . The process of  claim 1 , further comprising an initial step of providing the implant, wherein the implant has:
 a body having a top surface, a bottom surface, opposing lateral sides, opposing anterior and posterior portions, a substantially hollow center, and a single vertical aperture; and   optionally, at least one of a first integration plate affixed to the top surface of the body and a second integration plate affixed to the bottom surface of the body, wherein the first integration plate and the second integration plate each have a top surface, a bottom surface, opposing lateral sides, opposing anterior and posterior portions, and a single vertical aperture extending from the top surface to the bottom surface and aligning with the single vertical aperture of the body,   wherein the at least one soft tissue surface comprises at least one of the opposing lateral sides of the body, the opposing anterior and posterior portions of the body, the opposing lateral sides of the first integration plate, the opposing anterior and posterior portions of the first integration plate, the opposing lateral sides of the second integration plate, and the opposing anterior and posterior portions of the second integration plate.   
     
     
         10 . The process of  claim 1 , further comprising an initial step of providing the implant, wherein the implant has:
 a body having a top surface, a bottom surface, opposing lateral sides, opposing anterior and posterior portions, a substantially hollow center, a single vertical aperture defining at least one surface, at least one transverse aperture defining at least one surface, and an optional opening defining at least one surface;   the body having generally rounded and blunt intersections defined along the entire lengths between the top surface and the lateral sides and the bottom surface and the lateral sides;   the body having at least one sharp edge between the top and bottom surfaces and the anterior portion or the posterior portion;   wherein the at least one integration surface comprises at least one of the top surface of the body and the bottom surface of the body;   wherein the at least one graft contact surface comprises at least one of the surfaces defined by the single vertical aperture, the at least one transverse aperture, and the optional opening; and   wherein the at least one soft tissue surface comprises at least one of the opposing lateral sides of the body, the opposing anterior and posterior portions of the body, and the generally rounded and blunt intersections of the implant.   
     
     
         11 . The process of  claim 1 , further comprising an initial step of providing the implant, wherein the implant has:
 a body having a top surface, a bottom surface, opposing lateral sides, opposing anterior and posterior portions, a substantially hollow center, a single vertical aperture defining at least one surface, at least one transverse aperture defining at least one surface, and an optional opening defining at least one surface;   the body having generally rounded and blunt intersections defined along the entire lengths between the top surface and the lateral sides and the bottom surface and the lateral sides;   the body having at least one sharp edge between the top and bottom surfaces and the anterior portion or the posterior portion;   wherein the at least one integration surface comprises the top surface of the body and the bottom surface of the body;   wherein the at least one graft contact surface comprises the surfaces defined by the single vertical aperture, the at least one transverse aperture, and the optional opening; and   wherein the at least one soft tissue surface comprises the opposing lateral sides of the body, the opposing anterior and posterior portions of the body, and the generally rounded and blunt intersections.   
     
     
         12 . The process of  claim 1 , further comprising an initial step of providing the implant, wherein the implant has:
 a body having a top surface, a bottom surface, opposing lateral sides, opposing anterior and posterior portions, a substantially hollow center, a single vertical aperture defining at least one surface, at least one transverse aperture defining at least one surface, and optionally an opening defining at least one surface;   a first integration plate affixed to the top surface of the body and a second integration plate affixed to the bottom surface of the body, wherein the first integration plate and the second integration plate each have a top surface, a bottom surface, opposing lateral sides, opposing anterior and posterior portions, and a single vertical aperture extending from the top surface to the bottom surface and aligning with the single vertical aperture of the body, defining a transverse rim;   the body having generally rounded and blunt intersections defined along the entire lengths between the top surface and the lateral sides and the bottom surface and the lateral sides;   the first and second integration plates having at least one sharp edge between the top surfaces and the anterior portion or the posterior portion;   wherein the at least one integration surface comprises at least one of the top surfaces of the first and second integration plates;   wherein the at least one graft contact surface comprises at least one of the surfaces defined by the single vertical aperture, the at least one transverse aperture, and the optional opening; and   wherein the at least one soft tissue surface comprises at least one of the opposing lateral sides of the body, the opposing anterior and posterior portions of the body, the opposing lateral sides of the first integration plate, the opposing anterior and posterior portions of the first integration plate, the opposing lateral sides of the second integration plate, the opposing anterior and posterior portions of the second integration plate, and the generally rounded and blunt intersections.   
     
     
         13 . A process of fabricating a predetermined surface topography on at least one surface of an implant comprising:
 providing an implant including:
 (a) a body having a top surface, a bottom surface, opposing lateral sides, opposing anterior and posterior portions, a substantially hollow center, a single vertical aperture defining at least one surface, and at least one transverse aperture defining at least one surface; 
 (b) the body having generally rounded and blunt intersections defined along the entire lengths between the top surface and the lateral sides and the bottom surface and the lateral sides; 
 (c) the body having at least one sharp edge between the top and bottom surfaces and the anterior portion or the posterior portion; 
 (d) integration surfaces including the top surface of the body and the bottom surface of the body; 
 (e) graft contact surfaces including the surfaces defined by the single vertical aperture and the at least one transverse aperture; and 
 (f) soft tissue surfaces including the opposing lateral sides of the body, the opposing anterior and posterior portions of the body, and the generally rounded and blunt intersections; 
   macro processing the integration surfaces to form macro features;   micro processing the integration surfaces and the graft contact surfaces to form micro features; and   nano processing the integration surfaces, the graft contact surfaces, and the soft tissue surfaces to form nano features.   
     
     
         14 . The process of  claim 13 , wherein the macro processing includes mechanical or chemical bulk removal; the micro processing includes acid etching; and the nano processing includes acid etching. 
     
     
         15 . The process of  claim 14 , wherein the nano processing comprises:
 preparing an acid solution comprising hydrochloric acid, water, and titanium;   applying the acid solution to the integration surfaces, the graft contact surfaces, and the soft tissue surfaces;   removing the acid solution by rinsing with water; and   heating and subsequently cooling the integration surfaces, the graft contact surfaces, and the soft tissue surfaces.   
     
     
         16 . The process of  claim 15 , wherein the acid solution comprises a concentration of 25-31% hydrochloric acid. 
     
     
         17 . The process of  claim 15 , wherein the titanium is seeded in the acid solution or is present from titanium previously removed from at least one surface of the implant. 
     
     
         18 . The process of  claim 15 , wherein the acid solution is heated to a temperature of about 200-210° F. when applied, and the acid solution is applied to the integration surfaces, the graft contact surfaces, and the soft tissue surfaces for a period of time of about 15-25 minutes. 
     
     
         19 . A process of fabricating a predetermined surface topography on at least one surface of an implant comprising:
 providing an implant including:
 (a) a body having a top surface, a bottom surface, opposing lateral sides, opposing anterior and posterior portions, a substantially hollow center, a single vertical aperture defining at least one surface, and at least one transverse aperture defining at least one surface; and 
 (b) a first integration plate affixed to the top surface of the body and a second integration plate affixed to the bottom surface of the body, wherein the first integration plate and the second integration plate each have a top surface, a bottom surface, opposing lateral sides, opposing anterior and posterior portions, and a single vertical aperture extending from the top surface to the bottom surface and aligning with the single vertical aperture of the body, defining a transverse rim; 
 (c) the body having generally rounded and blunt intersections defined along the entire lengths between the top surface and the lateral sides and the bottom surface and the lateral sides; 
 (d) the first and second integration plates having at least one sharp edge between the top surfaces and the anterior portion or the posterior portion; 
 (e) integration surfaces including at least one of the top surfaces of the first and second integration plates; 
 (f) graft contact surfaces including at least one of the surfaces defined by the single vertical aperture and the at least one transverse aperture; and 
 (g) soft tissue surfaces including at least one of the opposing lateral sides of the body, the opposing anterior and posterior portions of the body, the opposing lateral sides of the first integration plate, the opposing anterior and posterior portions of the first integration plate, the opposing lateral sides of the second integration plate, the opposing anterior and posterior portions of the second integration plate, and the rounded and blunt intersections; 
   macro processing the integration surfaces to form macro features;   micro processing the integration surfaces and the graft contact surfaces to form micro features; and   nano processing the integration surfaces, the graft contact surfaces, and the soft tissue surfaces to form nano features.   
     
     
         20 . The process of  claim 19 , wherein the macro processing includes mechanical or chemical bulk removal; the micro processing includes acid etching; and the nano processing includes acid etching.