Transcutaneous prosthesis

• US 8,628,584 B2
• Filed: 01/03/2006
• Issued: 01/14/2014
• Est. Priority Date: 06/23/2000
• Status: Expired due to Term

• Current Assignee: University College London (University of London)
• Original Assignee: University College London (University of London)
• Inventors: Blunn, Gordon, Cobb, Justin, Goodship, Allen, Unwin, Paul
• Primary Examiner(s): Matthews, William H.
• Application Number:
  US11/306,584
• Publication Number:
  US 20070073412A1
• Time in Patent Office: 2,933 Days
• Field of Search: 623/11.11, 623/16.11, 623/23.48, 623/23.49, 623/23.5, 623/23.55, 623/23.56, 623/23.57, 623/23.76
• US Class Current: 623/23.76
• 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 8/0018 characterised by the shape
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/2814 Bone stump caps
• CPC Class Codes: A61F 2/30749 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2/54 Artificial arms or hands or parts thereof
• CPC Class Codes: A61F 2/60 Artificial legs or feet or parts thereof
• CPC Class Codes: A61F 2/78 Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
• CPC Class Codes: A61F 2002/0081 directly machined on the prosthetic surface, e.g. holes, grooves A61F2/30771 takes precedence
• CPC Class Codes: A61F 2002/0086 for preferentially controlling or promoting the growth of specific types of cells or tissues
• CPC Class Codes: A61F 2002/009 for hindering or preventing attachment of biological tissue
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30225 Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/30322 differing in surface structures
• CPC Class Codes: A61F 2002/30558 Force-limiting means
• CPC Class Codes: A61F 2002/30561 breakable or frangible
• CPC Class Codes: A61F 2002/30574 with an integral complete or partial collar or flange
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/30838 : Microstructures
• CPC Class Codes: A61F 2002/30845 : with cutting edges
• CPC Class Codes: A61F 2002/30878 : with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
• CPC Class Codes: A61F 2002/30879 : Ribs
• CPC Class Codes: A61F 2002/30929 : having at least two superposed coatings
• CPC Class Codes: A61F 2002/3093 : for promoting ingrowth of bone tissue
• CPC Class Codes: A61F 2002/7887 : for connecting limb exoprostheses to the stump bone
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2250/0026 : differing in surface structures
• CPC Class Codes: A61F 2250/0073 : Force-limiting means
• CPC Class Codes: A61F 2250/0074 : Torque-limiting means
• CPC Class Codes: A61F 2310/0058 : Coating made of diamond or of diamond-like carbon DLC
• CPC Class Codes: A61F 2310/00604 : Coating made of aluminium oxide or hydroxides
• CPC Class Codes: A61F 2310/00796 : Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
• CPC Class Codes: A61F 2310/00976 : Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
• CPC Class Codes: A61L 2430/02 : for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/28 : Materials for coating prostheses
• CPC Class Codes: A61L 27/303 : Carbon
• CPC Class Codes: A61L 27/34 : Macromolecular materials
• CPC Class Codes: C08L 89/00 : Compositions of proteins; Compositions of derivatives thereof foodstuff preparations A23J3/00

Abstract

A transcutaneous prosthesis includes a first component shaped for implantation into a bone, the first component including flutes or grooves on a surface thereof for deterring rotation of the prosthesis within a bone; a second component adapted for location between the bone and the skin, the second component having a surface treatment for stimulation of fibroblastic cell proliferation and attachment of epithelial cells; and a third component adapted for location to extend from the skin surface and is adapted to extend directly from the skin surface in use, the third component having a coating of a non-stick material on an outer surface thereof, the coating having a surface energy that is lower than a surface energy of the first and second components and which is low enough to deter bacterial adhesion.

Claims

1. A transcutaneous prosthesis which comprises:

a first component shaped for implantation into a bone;

a second component adapted for location between the bone and the skin, the second component having an outer surface having one or more surface treatments for stimulation of fibroblastic cell proliferation and attachment of epithelial cells, the surface treatments being porous, being micro-pitted, and/or being coated with an external coating of a material selected from hydrated calcium phosphate, adhesion promoting proteins and alumina oxide ceramics; and

a third component adapted for location to extend directly from the skin surface in use, the third component having an outer surface thereof, wherein the outer surface of the third component comprises a non-stick material whereby the surface has a surface energy that is lower than a surface energy of the first and second components and which deters bacterial adhesion,

wherein, in use, a transition from the second component to the third component is essentially at the surface of the skin and the third component extends from the skin surface, such that the non-stick outer surface of the third component is adjacent to the surface treated outer surface of the second component when the first component is implanted in a bone.

2. A prosthesis according to claim 1 wherein the components are integrally formed and have different surface treatments.

3. A prosthesis according to claim 1, wherein the first component has a surface treatment which stimulates bone growth and osseous integration.

4. A prosthesis according to claim 1, wherein the second component has a micro-pitted surface.

5. A prosthesis according to claim 1, wherein the surface of the second component carries a protein coating.

6. A prosthesis according to claim 1, wherein the second component extends outwardly from the first and third components.

7. A prosthesis according to claim 6, wherein the second component has through-holes.

8. A prosthesis according to claim 1, where the third component carries a coating comprising a fluoro- or silicone polymer.

9. A prosthesis according to claim 1, wherein the third component carries a coating comprising diamond like carbon.

10. A prosthesis according to claim 1, wherein the third component includes a frangible or detachable linkage which permits an external component to detach in the event that an unusually high load is applied to the prosthesis.

11. A prosthesis according to claim 1, in which the third component is adapted for connection to an artificial limb or digit.

12. A prosthesis according to claim 5, wherein the protein coating is fibronectin or laminin.

13. A prosthesis according to claim 1, wherein the surface of the second component carries a hydrated calcium phosphate coating.

14. A prosthesis as claimed in claim 13, wherein the hydrated calcium phosphate coating is a coating of hydroxy apatite.

15. A prosthesis as claimed in claim 1, wherein the surface energy of the third component is a surface energy level of a non-stick material comprising a fluoro or silicone polymer or diamond-like carbon.

37. A prosthesis according to claim 6, wherein the second component extends in an outward direction perpendicular to the first and third components, said second component thereby defining a substantially planar surface.

38. A prosthesis according to claim 37, wherein the second component has through holes, each through hole defining an opening in the substantially planar surface of the second component.

39. A prosthesis according to claim 6, wherein the second component is mushroom shaped.

16. A transcutaneous prosthesis which comprises:

a first component shaped for implantation into a bone, the first component including means on a surface thereof for deterring rotation of the prosthesis within a bone;

a second component adapted for location between the bone and the skin, the second component having a surface treatment for stimulation of fibroblastic cell proliferation and attachment of epithelial cells; and

a third component adapted for location to extend from the skin surface and adapted to extend directly from the skin surface in use, wherein the second component is located between the first and third components in use, the third component having a coating of a non-stick material on an outer surface thereof, the coating having a surface energy that is lower than a surface energy of the first and second components so as to deter bacterial adhesion on the third component.

17. A prosthesis according to claim 16, wherein the components are integrally formed and have different surface treatments.

18. A prosthesis according to claim 16, wherein the second component has a micro-pitted surface.

19. A prosthesis according to claim 16, where the non-stick coating of the third component comprises a fluoro- or silicone polymer.

20. A prosthesis according to claim 16, where the non-stick coating of the third component comprises diamond like carbon.

21. A prosthesis according to claim 16, wherein the surface of the second component carries a protein coating.

22. A prosthesis according to claim 16, wherein the surface of the second component carries a hydrated calcium phosphate coating.

23. A transcutaneous prosthesis which comprises:

a first component shaped for implantation into a bone,

a second component adapted for location between the bone and the skin, the second component having a surface treatment for stimulation of fibroblastic cell proliferation and attachment of epithelial cells, and

a third component adapted for location to extend from the skin surface and adapted to extend directly from the skin surface, in use, wherein the second component is located between the first and third components in use, wherein an outer surface of the third component comprises a non-stick material, whereby the outer surface of the third component has a surface energy that is lower than a surface energy of the first and second components and which deters bacterial adhesion,

wherein a distance between the first component and the third component is such that a transition from the second component to the third component is essentially at the surface of the skin and the third component extends from the skin surface when the first component is implanted in a bone.

24. A prosthesis according to claim 23, wherein the components are integrally formed and have different surface treatments.

25. A prosthesis according to claim 23, wherein the second component has a micro-pitted surface.

26. A prosthesis according to claim 23, where the non-stick coating of the third component comprises a fluoro- or silicone polymer.

27. A prosthesis according to claim 23, where the non-stick coating of the third component comprises diamond like carbon.

28. A prosthesis according to claim 23, wherein the surface of the second component carries a protein coating.

29. A prosthesis according to claim 23, wherein the surface of the second component carries a hydrated calcium phosphate coating.

30. A transcutaneous prosthesis which comprises:

a first component shaped for implantation into a bone,

a second component adapted for location between the bone and the skin, the second component having a surface treatment for stimulation of fibroblastic cell proliferation and attachment of epithelial cells, and

a third component adapted for location to extend from the skin surface and adapted to extend directly from the skin surface, in use,

wherein the second component is located between the first and third components in use, the third component having an outer surface,

wherein the outer surface of the third component has a non-stick coating material whereby it has a surface energy that is lower than a surface energy of the first and second components and which deters bacterial adhesion,

wherein a distance between the first component and the third component is such that a transition from the second component to the third component is essentially at the surface of the skin and the third component extends from the skin surface when the first component is implanted in a bone.

31. A prosthesis according to claim 30, wherein the components are integrally formed and have different surface treatments.

32. A prosthesis according to claim 30, wherein the second component has a micro-pitted surface.

33. A prosthesis according to claim 30, where the non-stick coating of the third component comprises a fluoro- or silicone polymer.

34. A prosthesis according to claim 30, where the non-stick coating of the third component comprises diamond like carbon.

35. A prosthesis according to claim 30, wherein the surface of the second component carries a protein coating.

36. A prosthesis according to claim 30, wherein the surface of the second component carries a hydrated calcium phosphate coating.

40. A transcutaneous prosthesis for implantation with a bone and skin, comprising:

a first component for implanting into the bone;

a second component for implanting between the bone and the skin, the second component including an outer surface having one or more surface treatments for stimulation of fibroblastic cell proliferation and attachment of epithelial cells; and

a third component for extending directly from the skin in use, the third component having an outer surface comprising of a non-stick material, wherein the outer surface has a surface energy which is low enough to deter bacterial adhesion,

wherein, in use, the first component is implanted such that a transition from the second component to the third component is essentially at the surface of the skin and the third component extends from the skin surface when the first component is implanted in the bone, such that the non-stick outer surface of the third component is adjacent to the surface treated outer surface of the second component.

41. A transcutaneous prosthesis adapted for surgical attachment to bone and skin, comprising:

a first component implanted into a bone;

a second component positioned between the bone and the skin, the second component including an outer surface having one or more surface treatments for stimulation of fibroblastic cell proliferation and attachment of epithelial cells; and

a third component extending directly from the skin in use, the third component having an outer surface comprising of a non-stick material, wherein the outer surface has a surface energy which deters bacterial adhesion,

the second component is positioned between the first component and the third component in use, such that the non-stick outer surface of the third component is adjacent to the surface treated outer surface of the second component, and

wherein, in use, the first component is implanted in a bone such that a transition from the second component to the third component is essentially at the surface of the skin and the third component extends from the skin surface.

42. A transcutaneous prosthesis comprising:

a first component shaped for implantation into a bone,

a second component adapted for location between the bone and the skin, the second component having a surface treatment for stimulation of fibroblastic cell proliferation and attachment of epithelial cells, and

a third component adapted for location to extend directly from the skin surface in use, the third component having an outer surface thereof, wherein the outer surface of the third component comprises a non-stick material whereby the surface has a low surface energy that is lower than a surface energy of the first and second components and which deters bacterial adhesion,

the second component being located between the first component and the third component in use, such that the non-stick outer surface of the third component is adjacent to the surface treated outer surface of the third component.