Osseointegration promoting implant composition, implant assembly and method therefor

• US 5,503,558 A
• Filed: 11/12/1993
• Issued: 04/02/1996
• Est. Priority Date: 11/12/1993
• Status: Expired due to Term

• Current Assignee: Urist Regenerative Med Inc.
• Original Assignee: McGill University
• Inventors: Clokie, Cameron M. L.
• Primary Examiner(s): Lucchesi, Nicholas D.
• Application Number:
  US08/151,537
• Time in Patent Office: 872 Days
• Field of Search: 433/172, 433/173, 433/174, 433/175, 433/176, 433/201.1, 433/215
• US Class Current: 433/173
• CPC Class Codes: A61C 8/0018 characterised by the shape
• CPC Class Codes: A61C 8/005 Connecting devices for joining an upper structure with an implant member, e.g. spacers
• CPC Class Codes: A61C 8/0054 having a cylindrical implant connecting part
• CPC Class Codes: A61C 8/006 with polygonal positional means, e.g. hexagonal or octagonal
• CPC Class Codes: A61C 8/0069 tapered or conical connection
• CPC Class Codes: A61K 38/1841 Transforming growth factor [TGF]
• CPC Class Codes: A61L 27/227 Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders

Abstract

A liquid composition comprising a transforming growth factor β (TGF-β) in a liquid carrier which gels at about 37° C., promotes osseointegration of an implant in bone, when introduced into a bore in the bone, prior to insertion of the implant in the bone; a method of placing an implant in bone comprises injecting said liquid composition into a bore in the bone prior to insertion of the implant in the bore, the TGF-β being present in the liquid composition in a concentration effective in an interspace between an inner surface of the bore and an outer surface of the implant, to promote osseointegration.

Claims

1. In a method of placing an implant in bone, in which a bore is formed in the bone and the implant is inserted into the bone, the improvement in which a liquid composition comprising a transforming growth factor β

(TGF-β

) in a liquid carrier is injected into said bore prior to insertion of the implant in the bore, said liquid carrier being gelable at about 37°

C., and said TGF-β

being present in said liquid composition in a concentration effective in an interspace between an inner surface of said bore and an outer surface of said implant, to promote osseointegration at the interface between said inner surface and said outer surface.

2. A method according to claim 1, in which said TGF-β

is TGF-β

₁.

3. A method according to claim 2, in which at least an outer portion of said implant is of titanium and an outer surface of said outer portion is oxidized titanium.

4. A method according to claim 3, in which said implant is of titanium.

5. A method according to claim 3, in which said implant has a core of a non-metal.

6. A method according to claim 3, in which said liquid carrier is a collagen.

7. A method according to claim 3, in which said liquid carrier is a polyoxyalkylene block copolymer having a molecular weight of at least 1000 and bearing terminal hydroxyl groups.

8. A method according to claim 7, wherein said interspace has a width of 10 μ

m to 100 μ

m and said composition contains 0.5 to 20 μ

g/ml of said TGF-β

₁.

9. An implant assembly comprising, in combination:

i) an osseointegration promoting implant composition comprising a transforming growth factor β

(TGF-β

) in a liquid carrier, said liquid carrier being gelable at about 37°

C., said TGF-β

being present in said liquid carrier in an amount effective to promote osseointegration at the interface between a bore in a bone for an implant, and an outer surface of the implant, and

ii) an implant component having a stem for insertion in a bore in a bone, and a support base for a prosthesis integral with said stem, said support base being located at a terminal end of said stem and having means to anchor the prosthesis, said composition having a liquid form adapted to be injected in a bore in a bone prior to insertion of said stem in the bore.

10. A combination according to claim 9, wherein said TGF-β

is TGF-β

₁.

11. A combination according to claim 10, wherein at least an outer portion of said implant component is of titanium and an outer surface of said outer portion is oxidized titanium.

12. A combination according to claim 11, wherein said liquid carrier is a collagen.

13. A combination according to claim 11, wherein said liquid carrier is a block copolymer of formula:

space="preserve" listing-type="equation">HO(CH.sub.2 CH.sub.2 O).sub.a -(CH(CH.sub.3)CH.sub.2 OH).sub.b (CH.sub.2 CH.sub.2 O).sub.c H

where b comprises at least 15%, by weight, and segments a+c comprise 20 to 85%, by weight.

14. A combination according to claim 9, wherein said liquid carrier is a polyoxyalkylene block copolymer having a molecular weight of at least 1000 and bearing terminal hydroxyl groups.

15. A combination according to claim 14, wherein said TGF-β

₁ is present in a concentration of 5 to 15 μ

g/ml.