HYBRID COMPOSITE INTERBODY FUSION DEVICE

• US 20030065393A1
• Filed: 09/28/2001
• Published: 04/03/2003
• Est. Priority Date: 09/28/2001
• Status: Active Grant

• Current Assignee: Depuy Acromed Incorporated (Johnson & Johnson)
• Original Assignee: Depuy Acromed Incorporated (Johnson & Johnson)
• Inventors: Serhan, Hassan, Moumene, Missoum
• Granted Patent: US 6,569,201 B2
• Time in Patent Office: Days
• US Class Current: 623/17.11
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/446 having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
• CPC Class Codes: A61F 2/4465 having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
• CPC Class Codes: A61F 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30354 Cylindrically-shaped protrusion and recess, e.g. cylinder of circular basis
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/30777 Oblong apertures
• CPC Class Codes: A61F 2002/30818 castellated or crenellated
• CPC Class Codes: A61F 2002/30841 Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2310/00017 Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00179 Ceramics or ceramic-like structures
• CPC Class Codes: A61F 2310/00329 Glasses, e.g. bioglass
• CPC Class Codes: Y10S 606/907 : Composed of particular material or coated
• CPC Class Codes: Y10S 606/908 : Bioabsorbable material
• CPC Class Codes: Y10S 606/91 : Polymer

Abstract

This invention relates to an interbody fusion device comprising:

a) a non-resorbable support having an outer surface, the support having an osteoconductive pore passing therethrough and opening onto at least two openings on the outer surface, and

b) a first bioresorbable layer disposed upon the outer surface of the support, wherein the first bioresorbable layer has a thickness TH of at least 100 μm.

Claims

1. An interbody fusion device comprising:

a) a non-resorbable support having an outer surface, the support having an osteoconductive pore passing therethrough and opening onto at least two openings on the outer surface, and

b) a first bioresorbable layer disposed upon the outer surface of the support,

wherein the first bioresorbable layer has a thickness TH of at least 100 μ

m.

2. The device of claim 1 wherein the outer surface comprises upper and lower contact surfaces, and wherein the first bioresorbable layer is disposed upon at least one of the contact surfaces.

3. The device of claim 2 wherein the first bioresorbable layer is disposed upon the upper contact surface.

4. The device of claim 2 wherein the first bioresorbable layer is disposed upon the lower contact surface.

5. The device of claim 2 comprising first and second openings, wherein the first opening is formed in the upper contact surface and wherein the second opening is formed in the lower contact surface.

6. The device of claim 5 wherein the first opening has a perimeter, and wherein the first bioresorbable layer is disposed upon a portion of the upper contact surface and is located substantially adjacent the perimeter of the first opening in the upper contact surface.

7. The device of claim 5 wherein the upper contact surface has a perimeter, and wherein the first bioresorbable layer is disposed upon a portion of the upper contact surface and is located substantially adjacent the perimeter of the upper contact surface.

8. The device of claim 5 wherein the thickness of the first bioresorbable layer is at least 200 μ

m.

9. The device of claim 5 wherein the thickness of the first bioresorbable layer is at least 500 μ

m.

10. The device of claim 5 wherein the thickness of the first bioresorbable layer is at least 500 μ

m.

11. The device of claim 5 wherein the thickness of the first bioresorbable layer is between 1 mm and 8 mm.

12. The device of claim 5 wherein the thickness of the first bioresorbable layer is between 2 mm and 4 mm.

13. The device of claim 5 further comprising:

c) a second bioresorbable layer,

wherein the first bioresorbable layer is disposed upon the upper contact surface, and the second bioresorbable layer is disposed upon the lower contact surface.

14. The device of claim 1 wherein the outer surface comprises upper and lower contact surfaces, and at least a first side surface therebetween, and the first bioresorbable layer is disposed upon the first side surface and extends beyond at least one of the upper and lower contact surfaces.

15. The device of claim 14 further comprising:

c) a second bioresorbable layer,

wherein the outer surface further comprises a second side surface between the upper and lower contact surfaces, and the second bioresorbable layer is disposed upon the second side surface and extends beyond at least one of the upper and lower contact surfaces.

16. The device of claim 15 wherein each bioresorbable layer extends beyond each contact surface.

17. The device of claim 1 wherein the osteoconductive pore forms a void within the support, the void defining a void volume and an inner surface, wherein the outer surface of the support defines a support volume, wherein the void volume is at least 10-50% of the support volume.

18. The device of claim 17 wherein the support is a cage.

19. The device of claim 1 wherein the first bioresorbable layer forms at least one tooth extending away from the outer surface upon which the first bioresorbable layer is disposed.

20. The device of claim 19 wherein the outer surface comprises upper and lower contact surfaces, and wherein first bioresorbable layer is disposed upon at least one of the contact surfaces.

21. The device of claim 20 wherein the contact surface upon which the first bioresorbable layer is disposed has a perimeter, and wherein the at least one tooth has a leading edge facing the perimeter of the contact surface upon which it is disposed.

22. The device of claim 1 wherein the bioresorbable layer has a resorption time of between 3 months and 48 months.

23. The device of claim 1 wherein the bioresorbable layer comprises a polymer.

24. The device of claim 23 wherein the polymer is selected from the group consisting of PLA, PGA, and copolymers thereof.

25. An interbody fusion device comprising:

a) a non-resorbable support having an outer surface, the support having an osteoconductive pore passing therethrough and opening onto at least two openings on the outer surface, and

a first bioresorbable layer comprising a polymer, the layer contacting the support and extending beyond the outer surface of the support, wherein the first bioresorbable layer has a thickness TH of at least 100 μ

m.

26. The device of claim 25 wherein the osteoconductive pore defines an inner surface of the support, and the first bioresorbable layer contacts the inner surface of the support.

27. The device of claim 26 wherein the outer surface comprises upper and lower contact surfaces, and wherein the first bioresorbable layer extends beyond at least one of the upper and lower contact surfaces.

28. The device of claim 27 wherein the first bioresorbable layer extends beyond each of the upper and lower contact surfaces.

29. The device of claim 28 wherein the first opening is formed in the upper contact surface and wherein the second opening is formed in the lower contact surface.

30. The device of claim 29 wherein the first bioresorbable layer forms at least one tooth extending away from the outer surface upon which the first bioresorbable layer is disposed.

31. An interbody fusion device comprising:

a) a non-resorbable support having an outer surface, the support having an osteoconductive pore passing therethrough and opening onto at least two openings on the outer surface, the pore defining an inner surface of the support, and

b) a first bioresorbable layer contacting the inner surface of the support and extending beyond the outer surface of the support,

wherein the contact of the bioresorbable layer upon the inner surface does not occlude at least two of the at least two openings at the outer surface, and wherein the first bioresorbable layer has a thickness TH of at least 100 μ

m.

32. The device of claim 31 wherein the outer surface comprises upper and lower contact surfaces, wherein the first bioresorbable layer extends beyond at least one of the upper and lower contact surfaces.

33. The device of claim 32 wherein the first bioresorbable layer extends beyond each of the upper and lower contact surfaces.

34. The device of claim 33 wherein the first opening is formed in the upper contact surface and wherein the second opening is formed in the lower contact surface, and wherein the contact of the bioresorbable layer upon the inner surface does not occlude the first and second openings at the outer surface.

35. The device of claim 34 wherein the first bioresorbable layer forms at least one tooth extending away from the contact surfaces.

37. The device of claim 33 wherein the at least one opening comprises an upper opening which opens onto the upper surface and has a perimeter, and wherein the wall surrounds at least one-half of the perimeter of the opening.

38. The device of claim 37 wherein the wall substantially surrounds the perimeter of the upper opening.

39. The device of claim 37 wherein the wall is disposed upon the upper surface.

40. The device of claim 37 wherein the support further comprises:

c) a lower surface, and

d) a side surface between the upper and lower surfaces, and

wherein the wall is disposed upon the side surface.

41. The device of claim 37 wherein the wall is bioresorbable.

36. An interbody fusion device comprising:

a) a non-resorbable support having an outer surface and an upper surface, the support having an osteoconductive pore passing therethrough and opening onto at least two openings on the outer surface, and

b) at least one wall disposed upon the outer surface of the support and extending above the upper surface to form a reservoir upon the upper surface,

wherein the first bioresorbable layer has a thickness TH of at least 100 μ

m.