Osteogenic device and a method for preparing the device

• US 7,186,811 B2
• Filed: 01/20/2004
• Issued: 03/06/2007
• Est. Priority Date: 02/29/1996
• Status: Expired due to Fees

• Current Assignee: Bioactive BONE Substitutes OY AB
• Original Assignee: Bioactive BONE Substitutes OY AB
• Inventors: Lindholm, Sam T., Marttinen, Aulis
• Primary Examiner(s): ROMEO, DAVID S
• Application Number:
  US10/759,244
• Publication Number:
  US 20050142164A1
• Time in Patent Office: 1,141 Days
• Field of Search: None
• US Class Current: 530/417
• CPC Class Codes: A61F 2/00 Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents as cosmetic articles, see the relevant subclasses, e.g. wigs, hair pieces, A41G3/00, A41G5/00; artificial nails A45D31/00; dental prostheses A61C13/00; materials for prostheses A61L27/00; artificial hearts A61M60/00; artificial kidneys A61M1/14
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/227 Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
• CPC Class Codes: A61L 27/24 Collagen
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/365 Bones
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: C07K 14/51 Bone morphogenetic factor; Osteogenins; Osteogenic factor; Bone-inducing factor
• CPC Class Codes: Y10S 530/84 Bones; tendons; teeth; cartilage

Abstract

The present invention is related to an osteogenic device and its preparation. Said device comprises a bone morphogenetic protein (BMP), preferably a modified BMP complex obtainable by a modification of the conventional guanidum hydrochloride extraction method and collagens, preferably collagen I or collagen IV, impregnated in and/or adsorbed on a bioceramic carrier, preferably a shapable body (block) originating from a coral skeleton. The method of isolating said modified BMP complex which lacks an immunogenic component and consists essentially of a 100–700 kD and a 15–25 kD protein with osteoinductive properties and preferably of the 15–25 kD protein which has improved storage properties as well as its use in the osteogenic device with improved osteoinductive properties is also disclosed.

Claims

1. A method for preparing a bone morphogenetic protein complex comprising:

(a) extracting protein from bone material with guanidinium hydrochloride (GuHCl);

(b) concentrating the extract by filtering with a tangential flow system and/or a ultrafiltration system;

(c) performing at least one dialysis of the concentrated extract against water or a buffer solution and dissolving insoluble material in buffered urea;

(d) performing a HPLC gel filtration of the buffered urea dissolved material to fractionate the protein material into three fractions, fraction I having a molecular weight of 100–

700 kD, fraction II, having a molecular weight of 25–

55 kD, and a fraction III having a molecular weight of 15–

25 kD; and

(e) drying and sterilizing fraction I.

2. The method of claim 1, further comprising combining fractions I and III and drying and sterilizing said fractions.