Implantable objects, guiding devices, and methods of use thereof

Abstract

Embodiments of the disclosure relate to implantable objects and guiding devices, as well as recipient site preparation instruments, bone-implantable materials, and methods of fabrication and use thereof.

We claim: 
     
         1 . A kit comprising:
 1) an implantable object that is substantially free of a thread and comprises a bone-engaging element (e.g., a macro-rough surface, longitudinal groove, flute, fin, post, or stud); and   2) a guiding device that provides positioning, reference, orientation or retention of an implantable object in a geometrically defined position to a bone (e.g., a host bone) at an implantation site.   
     
     
         2 . The kit of  claim 1 , further comprising a recipient site preparation instrument that acts subtractively or additively toward an implantation site to prepare said site for placement of an implantable object. 
     
     
         3 . The kit of  claim 1 , further comprising an adhesive composition comprising a multivalent metal salt and an acidic compound. 
     
     
         4 . The kit of  claim 3 , wherein the adhesive composition comprises an acidic compound of Formula (I): 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof, wherein:
 L is O, S, NH, or CH 2 ; 
 each of R 1a  and R 1b  is independently H, optionally substituted alkyl, or optionally substituted aryl; 
 R 2  is H, NR 4a R 4b , C(O)R 5 , or C(O)OR 5 ; 
 R 3  is H, optionally substituted alkyl, or optionally substituted aryl; 
 each of R 4a  and R 4a  is independently H, C(O)R 6 , or optionally substituted alkyl; 
 R 5  is H, optionally substituted alkyl, or optionally substituted aryl; 
 R 6  is optionally substituted alkyl or optionally substituted aryl; and 
 each of x and y is independently 0, 1, 2, or 3; 
 
         or Formula (II): 
       
       
         
           
           
               
               
           
         
         wherein:
 each of A 1 , A 2 , and A 3  is independently selected from an acidic group (e.g., a carboxyl or phosphonyl); and 
 each of L 1 , L 2 , and L 3  is independently bond, alkylene (e.g., C 1 -C 6  alkylene), or heteroalkylene (e.g., C 1 -C 6  heteroalkylene); 
 
         or Formula (III): 
       
       
         
           
           
               
               
           
         
         wherein:
 each of A 4 , A 5 , A 6 , and A 7  is independently an acidic group (e.g., a carboxyl or phosphonyl); 
 each of L 4 , L 5 , L 6 , and L 7  is independently bond, alkylene (e.g., C 1 -C 6  alkylene), or heteroalkylene (e.g., C 1 -C 6  heteroalkylene); and 
 M is alkylene (e.g., C 1 -C 6  alkylene) or heteroalkylene (e.g., C 1 -C 6  heteroalkylene). 
 
       
     
     
         5 . A method for repairing a bone comprising placement of an implantable object at an implantation site, comprising:
 (a) preparing the implantation site to receive the implantable object with a recipient site preparation instrument that matches the shape of the implantable object;   (b) optionally applying an adhesive composition to the bone, to the implantable object or to both;   (c) inserting the implantable object into implantation site in a desired orientation; and   (d) allowing the adhesive composition to cure.   
     
     
         6 . A method for repairing a bone comprising placement of an implantable object, comprising:
 (a) stripping the periosteum off the external bone surface at a desired location;   (b) applying an adhesive composition to the stripped bone;   (c) placing the implantable object in contact with the adhesive composition and the bone in the desired orientation and location;   (d) optionally inserting one or more retention bone screws; and   (e) allowing the adhesive composition to cure.   
     
     
         7 . The method of  claim 6 , wherein the implantable object is an endosseous implant or an eposteal implant. 
     
     
         8 . The method of  claim 6 , wherein the method further comprises stripping soft issue, e.g., periodontal ligament, granulation tissue, or cyst lining, and/or shaping the bone with a recipient site preparation instrument prior to or after application of the adhesive composition. 
     
     
         9 . The method of  claim 6 , wherein applying the adhesive composition is achieved by spreading or injecting. 
     
     
         10 . The method of  claim 6 , wherein step (e) occurs before or after step (c) or before or after step (d). 
     
     
         11 . A method for repairing a bone comprising:
 a) placing an implantable object at an implantation site, wherein the implantable object is substantially free of a thread and comprises a bone-engaging element (e.g., a macro-rough surface, longitudinal groove, flute, fin, post, or stud) and;   b) the implantation site is prepared with a recipient site preparation instrument that matches the shape of the implantable object.   
     
     
         12 . An implantable object, wherein the shape of the implantable object matches the size, shape, or other dimension of the implantation site and the implantable object comprises a smooth surface and a changing contour (e.g, to avoid a critical structure). 
     
     
         13 . An implantable object, wherein the implantable object is substantially free of a thread and comprises a bone-engaging element (e.g., a macro-rough surface, longitudinal groove, flute, fin, post, or stud). 
     
     
         14 . The implantable object of  claim 12 , wherein the implantation site comprises a bone or bone socket (e.g., tooth socket). 
     
     
         15 . The implantable object of  claim 12 , wherein the implantable object is custom produced (e.g., based on CAT scan data), e.g., to match the shape of the implant bed. 
     
     
         16 . The implantable object of  claim 12 , wherein the implantable object fits within the inner wall of the metaphysis or diaphysis cortex or is about the size and/or shape of a tooth root. 
     
     
         17 . The implantable object of  claim 12 , wherein the implantable object is between about 0.1 mm and about 50 mm in diameter (e.g., about 0.5 mm to about 25 mm or about 1 mm to about 10 mm). 
     
     
         18 . The implantable object of  claim 12 , wherein the implantable object comprises a port or opening. 
     
     
         19 . The implantable object of  claim 12 , wherein the implantable object is adhered to the implantation site (e.g., bone) by an adhesive composition. 
     
     
         20 . The implantable object of  claim 19 , wherein the adhesive composition comprises an acidic compound of Formula (I): 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof, wherein:
 L is O, S, NH, or CH 2 ; 
 each of R 1a  and R 1b  is independently H, optionally substituted alkyl, or optionally substituted aryl; 
 R 2  is H, NR 4a R 4b , C(O)R 5 , or C(O)OR 5 ; 
 R 3  is H, optionally substituted alkyl, or optionally substituted aryl; 
 each of R 4a  and R 4a  is independently H, C(O)R 6 , or optionally substituted alkyl; 
 R 5  is H, optionally substituted alkyl, or optionally substituted aryl; 
 R 6  is optionally substituted alkyl or optionally substituted aryl; and 
 each of x and y is independently 0, 1, 2, or 3; 
 
         or Formula (II): 
       
       
         
           
           
               
               
           
         
         wherein:
 each of A 1 , A 2 , and A 3  is independently selected from an acidic group (e.g., a carboxyl or phosphonyl); and 
 each of L 1 , L 2 , and L 3  is independently bond, alkylene (e.g., C 1 -C 6  alkylene), or heteroalkylene (e.g., C 1 -C 6  heteroalkylene); 
 
         or Formula (III): 
       
       
         
           
           
               
               
           
         
         wherein:
 each of A 4 , A 5 , A 6 , and A 7  is independently an acidic group (e.g., a carboxyl or phosphonyl); 
 each of L 4 , L 5 , L 6 , and L 7  is independently bond, alkylene (e.g., C 1 -C 6  alkylene), or heteroalkylene (e.g., C 1 -C 6  heteroalkylene); and 
 M is alkylene (e.g., C 1 -C 6  alkylene) or heteroalkylene (e.g., C 1 -C 6  heteroalkylene). 
 
       
     
     
         21 . A guiding device, wherein the guiding device provides reference, position, orientation or retention of an implantable object in a geometrically defined position to a bone (e.g., a host bone) at an implantation site. 
     
     
         22 . The guiding device of  claim 21 , wherein the guiding device comprises an opening for access to the space between the implantable object and an adhesive composition. 
     
     
         23 . The guiding device of  claim 21 , wherein the guiding device is substantially rigid. 
     
     
         24 . The guiding device of  claim 21 , wherein the guiding device is capable of release from the implantation site. 
     
     
         25 . The guiding device of  claim 21 , wherein the guiding device comprises a naturally occurring polymer (e.g., collagen, a modified collagen, or gelatin) or a synthetic polymer (e.g., rubber, elastomer, PGA, or PLGA). 
     
     
         26 . The guiding device of  claim 21 , wherein the guiding device comprises at least 2, at least 3, at least 4, at least 5, or at least 6 components. 
     
     
         27 . The guiding device of  claim 21 , wherein the implantable component is implanted fully in the bone. 
     
     
         28 . The guiding device of  claim 21 , wherein the implantable component is implanted partially in the bone. 
     
     
         29 . A recipient site preparation (RSP) instrument, wherein the RSP instrument acts subtractively or additively toward an implantation site to prepare said site for placement of an implantable object. 
     
     
         30 . The RSP instrument of  claim 29 , wherein the implantation site comprises a bone or bone socket (e.g., tooth socket). 
     
     
         31 . The RSP instrument of  claim 29 , wherein a component of the RSP instrument (e.g., the RSP head) is custom produced (e.g., based on CAT scan data), e.g., to match the shape of the implantable object. 
     
     
         32 . The RSP instrument of  claim 29 , wherein a component of the RSP instrument (e.g., the RSP head) fits within the inner wall of the metaphysis or diaphysis cortex or is about the size and/or shape of a tooth root. 
     
     
         33 . The RSP instrument of  claim 29 , wherein a component of the RSP instrument (e.g., the RSP head) exhibits a displacement swing amplitude from about 2 μm to about 2 mm. 
     
     
         34 . The RSP instrument of  claim 29 , wherein the direction of the displacement of a component of the RSP instrument (e.g., the RSP head) is aligned to be parallel with the path of insertion of the implantable object. 
     
     
         35 . The RSP instrument of  claim 29 , wherein a component of the RSP instrument (e.g., the RSP head) exhibits a subsonic vibration (e.g., less than about 60 Hz), a sonic vibration (e.g., between about 60 Hz to about 25,000 Hz), or an ultrasonic vibration is between about 0.1 mm and about 50 mm in diameter (e.g., about 0.5 mm to about 25 mm or about 1 mm to about 10 mm).