Coated Implants, Their Manufcturing And Use Thereof

• US 20070202144A1
• Filed: 03/09/2005
• Published: 08/30/2007
• Est. Priority Date: 03/10/2004
• Status: Active Grant

• Current Assignee: Scil Technology GmbH
• Original Assignee: Scil Technology GmbH
• Inventors: Hellerbrand, Klaus, Siedler, Michael, Schutz, Andreas, Schimkat, Bernd, Wiedenmann-Schlembach, Karin
• Granted Patent: US 8,372,419 B2
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 17/7291 for small bones, e.g. in the foot, ankle, hand or wrist
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 17/865 Packages or dispensers for bone screws or threaded wires
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61C 2202/02 Packaging for volatile material
• CPC Class Codes: A61C 8/0006 Periodontal tissue or bone regeneration support means for endoprosthetic bone substitute or bone graft implants A61F2/2846
• CPC Class Codes: A61C 8/0012 characterised by the material or composition, e.g. ceramics, surface layer, metal alloy use of specific materials A61K6/00
• CPC Class Codes: A61C 8/0013 with a surface layer, coating
• CPC Class Codes: A61C 8/0087 Means for sterile storage or manipulation of dental implants
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: B05C 3/02 the work being immersed in the liquid or other fluent material
• CPC Class Codes: B65B 55/00 : Preserving, protecting or purifying packages or package contents in association with packaging by packaging under special atmospheric or gaseous conditions B65B31/00; devices for placing protecting sheets, plugs, or wads over contents B65B61/22
• CPC Class Codes: C23C 10/20 : only one element being diffused
• CPC Class Codes: C23C 26/00 : Coating not provided for in groups C23C2/00 - C23C24/00
• CPC Class Codes: Y02T 50/60 : Efficient propulsion technologies, e.g. for aircraft

Abstract

The present invention relates to a method of coating of a device, preferably implants, with a substance comprising the steps of (a) contacting said device into a solution of said substrate or substance, and (b) drying said device while being submerged in said solution. The present invention also relates to a packaging container for a device, preferably an implant. Said packaging container being adapted such that said device is coatable within said packaging container. Moreover, the present invention relates to a method of coating the inner surfaces of a packaging container for a device, preferably implants, to be coated by a substance, comprising the steps of (a) siliconizing said inner surfaces of said container using a silicone emulsion, and (b) heat-curing to form a baked-in silicone layer on said inner surfaces of said container.

Claims

1. Method of coating of a device with a substance comprising the steps of:

(a) contacting said device into a solution of said substance, and

(b) drying said device while being in contact with said solution.

2. The method of claim 1, further comprising the step of removing volatile components from said solution of said substance.

3. The method of claim 2, wherein said removal step is performed before, simultaneously, or after step (b).

4. The method of claim 1, wherein said substance is a pharmaceutically active substance.

5. The method of claim 4, wherein said pharmaceutically active substance is a protein, peptide, polysaccharide or a glycolipid or a small molecule.

6. The method of claim 5, wherein said pharmaceutically active substance is immobilised in an inorganic or organic bioresorbable material.

7. The method of claim 5, wherein said pharmaceutically active substance is a dissolved osteoinductive protein.

8. The method of claim 1, wherein said substance comprises non-active ingredients.

9. The method of claim 1, wherein said substance comprises calcium phosphates.

10. The method of claim 1, wherein said drying step comprises isothermal drying.

11. The method of claim 1, wherein said coating of said device is performed while said device is received within its packaging container.

12. The method of claim 1, wherein said solution is an aqueous solution or an organic solvent.

13. The method of claim 1, wherein said solution is an acid aqueous solution.

14. The method of claims claim 1, wherein said solution contains an antioxidant.

15. The method of claim 14, wherein said antioxidant is methionin or its derivatives.

16. The method of claim 1, wherein said device is made of metal or metal alloy, preferably titanium or a titanium alloy.

17. The method of claim 1, wherein said device is a dental implant, or a coronary stent.

18. The method of claim 1, wherein step (a) comprises:

(a1) providing a packaging container for said device;

(a2) filling said coating solution into said container;

(a3) inserting said device into said filled container;

wherein the order of steps (a2) and (a3) can be reversed.

19. The method of claim 18, further comprising the steps of:

(a) applying a hydrophobic material onto said inner surfaces of said container, and

(b) heat-curing said applied material to form a baked-in layer on said inner surfaces of said container;

wherein said coating influences the distribution coefficient of the substance to be coated on said device between said container and said device.

20. The method of claim 19, wherein said hydrophobic material is silicone or PTFE.

21. The method of claim 19, wherein step (a) comprises siliconizing said inner surfaces using silicone emulsion.

22. The method of claim 18, said packaging container comprising a receptacle for receiving said device to be coated, said receptacle being adapted in size and shape to the size and shape of said device.

23. The method of claim 22, wherein the inner surface of said receptacle is coated.

24. The method of claim 18, further comprising the step of applying a vacuum for removing air bubbles, prior to step (b).

25. The method of claim 18, wherein step (b) is performed at about 100 hPa at ambient temperature.

26. The method of claim 18, wherein step (b) is performed using an ice-condenser.

27. The method of claim 18, further comprising the step of evacuating said container, venting it with nitrogen, and closing said container under nitrogen.

44. Coated device, obtainable by a method according to claim 1.

45. The coated device of claim 44, wherein said device is an implant.

46. The coated device of claim 45, wherein said implant is a dental implant.

47. The coated device of claim 45, wherein said implant is a stent, a nail, a cage, a screw, or a plate.

48. Use of said method of coating a device according to claim 1 for improving the homogeneous distribution of the coating on the device.

50. A kit comprising the device which is obtainable by the method of claim 1.

28. Packaging container for device, said packaging container being adapted such that said device is coatable with a substance directly within said packaging container by contacting said device into a solution of said substance and drying said device while being contact with said solution.

29. The packaging container according to claim 28, said packaging container being adapted in size and shape to the size and shape of said device.

30. The packaging container according to claim 28, wherein the inner surface of said packaging container is coated.

31. The packaging container according to claim 30, wherein the inner surface of said packaging container is coated with a layer of an inert hydrophobic or hydrophilic, material.

32. The packaging container according to claim 28, comprising a receptacle for receiving said device to be coated, said receptacle being adapted in size and shape to the size and shape of said device.

33. The packaging container according to claim 32, wherein the inner surface of said receptacle is coated.

34. The packaging container according to claim 33, wherein the inner surface of said receptacle is coated with a layer of an inert hydrophobic or hydrophilic, material.

35. The packaging container according to claim 31, wherein the hydrophobic material is a silicone.

36. The packaging container according to claim 31, wherein the hydrophobic material is PTFE.

37. The packaging container according to claim 28, wherein said receptacle is coaxially located within a container housing.

38. The packaging container according to claim 37, wherein said container housing comprises an opening for receiving said device and said coating substance, and a bottom portion being located opposite to said opening, wherein said receptacle comprises an opening for receiving said device and said coating substance, and a bottom portion being located opposite to said opening, said opening of said housing and said opening of said receptacle being aligned with each other, and wherein said receptacle is attached at its bottom portion to the bottom portion of said housing.

39. The packaging container according to claim 38, wherein the opening portion of said receptacle is spaced from the opening portion of said housing.

40. The packaging container according to claim 28, being made of glass.

41. Method of coating the inner surfaces of a packaging container for a device, preferably implants, to be coated by a substance, comprising the steps of:

(a) applying a hydrophobic material onto said inner surfaces of said container, and

(b) heat-curing said applied material to form a baked-in layer on said inner surfaces of said container;

wherein said coating influences the distribution coefficient of the substance to be coated on said device between said container and said device.

42. The method of claim 41, wherein said hydrophobic material is silicone or PTFE.

43. The method of claim 42, wherein step (a) comprises siliconizing said inner surfaces using silicone emulsion.

49. Use of said method of coating a packaging container according to claim 41 for improving and/or controlling the distribution coefficient of the substance to be coated on said device between said container and said device.