Biological lubricant composition and method of applying lubricant composition

• US 6,800,298 B1
• Filed: 05/11/2000
• Issued: 10/05/2004
• Est. Priority Date: 05/11/2000
• Status: Expired due to Term

• Current Assignee: Clemson University
• Original Assignee: Clemson University
• Inventors: Lickfield, Gary, Burdick, Julie-Anne Mason, Laberge, Martine
• Primary Examiner(s): Fredman, Jeffrey
• Application Number:
  US09/569,009
• Time in Patent Office: 1,608 Days
• Field of Search: 514/54, 514/59, 536/112, 264/4.32, 264/4.33, 424/450, 424/1, 424/489, 424/490, 424/213.3, 424/402.21, 424/24
• US Class Current: 424/489
• CPC Class Codes: A61K 31/683 Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
• CPC Class Codes: A61K 31/721 Dextrans
• CPC Class Codes: A61L 2400/10 Materials for lubricating medical devices
• CPC Class Codes: A61L 2430/24 for joint reconstruction
• CPC Class Codes: A61L 27/00 Materials for grafts or prostheses or for coating grafts or prostheses dental prostheses A61C13/00; shape or structure of prostheses A61F2/00; use of preparations for artificial teeth A61K6/80; artificial kidneys A61M1/14
• CPC Class Codes: A61L 27/28 Materials for coating prostheses
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61P 41/00 Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
• CPC Class Codes: C08L 5/02 Dextran; Derivatives thereof

Abstract

Fluid compositions and methods for lubrication of mammalian joints are disclosed, including both natural and artificial fluids. Synovial fluid acts to lubricate the bearing surfaces of bones and bone-like structures which are held in frictional contact within biological joints. Such fluids may be used to treat arthritic, injured, and diseased joints. Synovial fluid containing a dextran-based hydrogel with lipids provides enhanced rheological and tribological properties of such a fluid. Phospholipids are particularly useful in dextran-based compositions for synovial fluid. One phospholipid that can be used advantageously in synovial fluid is dipalmitoyl phosphatidylcholine (DPPC).

Claims

1. A biologically compatible injectable lubricant composition, comprising:

(a) a dextran-based hydrogel component, said dextran-based hydrogel component being adapted for serving as a carrier wherein said dextran-based hydrogel comprises a dextran/glycidyl methacrylate copolymer hydrogel;

(b) a suspension consisting of one or more phospholipids entrapped in the dextran-based hydrogel; and

(c) wherein said dextran is less than about 40% of the injectable lubricant composition by weight.

2. The composition of claim 1 in which said suspension of phospholipids comprises a phosphatidylcholine-based compound.

3. The composition of claim 2 wherein said phosphatidylcholine-based compound comprises dipalmitoyl phosphatidylcholine (DPPC).

4. The composition of claim 1 in which the rheology of the injectable lubricant composition is between about 1 and about 20 Pa(sec) at a temperature range of about 25-45°

C.

16. The composition of claim 1, wherein the dextran is between about 10% and about 40% of the injectable lubricant composition by weight.

17. The composition of claim 1, wherein the dextran is less than 10% of the injectable lubricant composition by weight.

5. A synthetic synovial fluid comprising:

(a) a dextran-based hydrogel carrier component comprising a dextran coupled with glycidyl methacrylate, and

(b) a suspension consisting of one or more phospholipids entrapped in the dextran-based hydrogel, wherein said one or more phospholipids are capable of contributing to the lubricating properties of articular cartilage.

6. The fluid of claim 5 wherein said one or more phospholipids is selected from the group of phospholipids consisting of:

phosphatidyl cholines, phosphatidyl ethanolamines, and mixtures thereof.

7. The fluid of claim 6 wherein the suspension of phospholipids comprises dipalmitoyl phosphatidylcholine (DPPC).

18. The fluid of claim 5, wherein the dextran is less than 40% of the synthetic synovial fluid by weight.

19. The fluid of claim 5, wherein the dextran is between about 10% and about 40% of the synthetic synovial fluid by weight.

20. The fluid of claim 5, wherein the dextran is less than 10% of the synthetic synovial fluid by weight.

21. The fluid of claims 5, wherein the dextran-based hydrogel is a degradable polymer.

8. An injectable synovial fluid composition comprising:

(a) a dextran-based hydrogel component wherein said dextran-based hydrogel comprises a dextran/glycidyl methacrylate copolymer hydrogel, and

(b) a suspension consisting of one or more phospholipids entrapped in the dextran-based hydrogel, said one or more phospholipids being selected from the group of phospholipids consisting of;

dipalmitoyl phosphatidylcholine (DPPC), phosphatidylethanolamine, phosphatidylserine, phosphatidylglycerol, phosphatidylinositol, sphingomyelin alpha-dipalmitoyl phosphatidylcholine, and mixtures thereof.

9. The composition of claim 8 wherein said suspension of phospholipids comprises dipalmitoyl phosphatidylcholine (DPPC).

10. The injectable synovial fluid composition of claim 8 wherein the dextran comprises from about 10 to about 40 percent by weight of the injectable synovial fluid composition.

11. The injectable synovial fluid composition of claim 8 wherein the dextran comprises between about 10 and about 20 percent by weight of said injectable synovial fluid composition.

22. The injectable synovial fluid composition of claim 8, wherein the dextran is less than 10% by weight of the injectable synovial fluid composition.

12. An injectable liquid synovial fluid composition comprising:

(a) a first component comprising a hydrogel matrix comprising dextran coupled with glycidyl methacrylate; and

(b) a suspension consisting of dipalmitoyl phosphatidylcholine entrapped within the hydrogel matrix.

13. The composition of claim 12 wherein the rheology of the injectable synovial fluid is between 1 and 20 Pa(sec) at a temperature range of 25-45°

C.

14. The composition of claim 12 additionally comprising a phosphate buffer.

23. The composition of claim 12, wherein the dextran is less than 40% of the composition by weight.

24. The composition of claim 12, wherein the dextran is less than 10% of the composition by weight.

15. A biologically compatible joint composition formed by combining:

(a) a dextran-based hydrogel comprising dextran coupled with glycidyl methacrylate; and

(b) one or more phospholipids, to form a suspension consisting of one or more phospholipids in the hydrogel, said one or more phospholipids being selected from the group of phospholipids consisting of;

dipalmitoyl phosphatidylcholine (DPPC), phosphatidylethanolamine, phosphatidylserine, phosphatidylglycerol, phosphatidylinositol, sphingomyelin alpha-dipalmitoyl phosphatidylcholine, and mixtures thereof.

25. The composition of claim 15, wherein the dextran is less than 40% of the composition by weight.

26. The composition of claim 15, wherein the dextran is less than 10% of the composition by weight.