Composite Bone Implants

Abstract

The invention provides natural multi-composite bone implants such as bone-connective tissue-bone and osteochondral implants for the replacement and/or repair of, for example and in particular a damaged or defective bone-meniscus-bone joint or a bone-patella tendon-bone joint or osteochondral lesions, methods of preparing the composites and uses thereof. The invention also provides natural or native composite bone-connective tissue-bone and osteochondral matrices or scaffolds that are substantially decellularised for subsequent transplantation/implantation.

1 .- 31 . (canceled) 
     
     
         32 . A method of preparing a decellularised multi-composite donor bone tissue matrix for subsequent implantation into a host comprising the steps of:
 (i) freezing and thawing the composite tissue matrix;   (ii) subjecting bone blocks to a fluid jet;   (iii) ultrasonicating the composite tissue matrix   (iv) in the instance of the multi-composite tissue matrix comprises a bone-connective tissue-bone structure, teasing apart fascicles at an enthesis region;   (v) incubating the composite tissue matrix in a hypotonic solution;   (vi) incubating the composite tissue matrix in a hypotonic solution comprising an anionic detergent;   (vii) subjecting the composite tissue matrix to hypotonic or isotonic washes;   (viii) incubating the tissue in a solution comprising at least one nuclease enzyme;   (ix) washing the composite tissue matrix; and   (x) further washing of the composite tissue matrix.   
     
     
         33 . The method of  claim 32 , wherein the temperature of the freezing steps is between −10 to −85° C. 
     
     
         34 . The method according to  claim 32 , wherein the fluid of the fluid jet is pressurised water or phosphate buffered saline (PBS). 
     
     
         35 . The method according to  claim 34 , wherein between 250-600 ml of fluid is used to water pile each bone block. 
     
     
         36 . The method according to  claim 32 , wherein the ultrasonic energy is applied to a solution in which the multi-composite donor bone tissue matrix is immersed. 
     
     
         37 . The method according to  claim 32 , wherein step (v) comprises firstly incubating the composite tissue matrix in a hypotonic solution under freeze/thaw conditions and subsequently a wash in hypotonic buffer under non freeze/thaw conditions. 
     
     
         38 . The method according to  claim 32 , further including a storage step the step comprising storing the decellularised composite donor bone-connective tissue-bone tissue matrix at between  − 10 to  − 85° C. 
     
     
         39 . The method according to  claim 32 , further including the step of incubating the composite tissue matrix with an oxidising agent prior to a final wash. 
     
     
         40 . A natural decellularised multi-composite bone transplant product produced by the method of  claim 32 . 
     
     
         41 . A method of treatment of an individual requiring knee repair or replacement surgery comprising the steps of preparing a decellularised natural donor bone-medial meniscal-bone transplant product according to the method of  claim 32  and replacing the defective or damaged knee joint with the decellularised natural bone-medial meniscus-bone transplant product. 
     
     
         42 . A method of treatment of an individual requiring patella tendon knee repair or replacement surgery comprising the steps of preparing a decellularised natural donor bone-patella tendon-bone transplant product according to the method of  claim 32  and replacing the defective or damaged area with the decellularised natural bone-patella tendon-bone transplant product. 
     
     
         43 . A method of treatment of an individual requiring osteochondral repair or replacement surgery comprising the steps of preparing a decellularised natural donor osteochondral transplant product according to the method of  claim 32  and replacing the defective or damaged area with the decellularised natural osteochondral transplant product.