Composite Bone Implants

Patent metadata

Field	Value
Publication number	US-2017232145-A1
Application number	US-201715583432-A
Country	US
Kind code	A1
Filing date	May 1, 2017
Priority date	Sep 4, 2012
Publication date	Aug 17, 2017
Grant date	—

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.

First claim

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.

Assignees

• Univ Leeds Innovations Ltd

Inventors

• Ingham Eileen
• Jones Gemma
• Fermor Hazel
• Fisher John
• HASAN Jahid

Classifications

• A61L27/3683

  subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment · CPC title

• A61L27/3821 Primary

  Bone-forming cells, e.g. osteoblasts, osteocytes, osteoprogenitor cells · CPC title

• A61L2430/40

  Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking · CPC title

• A61L2430/02

  for reconstruction of bones; weight-bearing implants · CPC title

• A61L27/3691

  characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation · CPC title