Surgical implant

• US 10,245,152 B2
• Filed: 07/25/2011
• Issued: 04/02/2019
• Est. Priority Date: 07/23/2010
• Status: Active Grant

• Current Assignee: Privelop-Spine AG
• Original Assignee: Privelop-Spine AG
• Inventors: Kloss, Henning
• Primary Examiner(s): Lawson, Matthew J
• Assistant Examiner(s): Sipp, Amy R
• Application Number:
  US13/811,438
• Publication Number:
  US 20130116793A1
• Time in Patent Office: 2,808 Days
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• 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 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30143 hexagonal
• CPC Class Codes: A61F 2002/30146 octagonal
• CPC Class Codes: A61F 2002/30149 pentagonal
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/30617 Visible markings for adjusting, locating or measuring
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/3092 having an open-celled or open-pored structure
• 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 2310/00089 Zirconium or Zr-based alloys
• CPC Class Codes: A61F 2310/00095 : Niobium or Nb-based alloys
• CPC Class Codes: A61F 2310/00101 : Molybdenum or Mo-based alloys
• CPC Class Codes: A61F 2310/00125 : Hafnium or Hf-based alloys
• CPC Class Codes: A61F 2310/00137 : Tungsten or W-based alloys
• CPC Class Codes: A61F 2310/00149 : Platinum or Pt-based alloys
• CPC Class Codes: A61F 2310/00155 : Gold or Au-based alloys
• CPC Class Codes: A61F 2310/00227 : containing titania or titanium oxide
• CPC Class Codes: A61F 2310/00239 : containing zirconia or zirconium oxide ZrO2

Abstract

The present invention is directed to a surgical implant for the fusion of two adjacent vertebrae with an upper plane for contacting an upper vertebral body and a lower plane for contacting a lower vertebral body and a tubular structure, wherein the tubular structure is formed by a plurality of tubes running from the upper plane to the lower plane and in substantially horizontal direction throughout one side of the surgical implant straight to the opposite side of the surgical implant. This tubular structure has the advantage that the formation and ingrowth of new bone is promoted and advantaged and that the degree of formation and ingrowth of new bone is detectable by X-ray measurements.

Claims

1. A radiopaque intervertebral metal implant for fusion of two bridged vertebral bodies comprising:

an upper plane for contacting an upper vertebral body;

a lower plane for contacting a lower vertebral body;

a tubular structure formed by a plurality of tubes for the fusion of the two bridged vertebral bodies, the plurality of tubes comprises vertical tubes and horizontal tubes, wherein the vertical tubes run from the upper plane to the lower plane and the horizontal tubes run in a substantially horizontal direction throughout one side of the intervertebral implant straight to the opposite side of the intervertebral implant thereby interconnecting the vertical tubes;

the horizontal tubes of the tubular structure are parallel to each other or are grouped into groups of parallel horizontal tubes so that X-ray spectra or radiographs are conductable through the horizontal tubes, and wherein all surfaces of the intervertebral metal implant have a roughness of 6.0 Ra to 8.5 Ra.

2. The radiopaque intervertebral metal implant according to claim 1, further comprising at least one cavity in the center of the implant extending from the upper plane to the lower plane, and a boundary layer surrounding the at least one cavity.

3. The radiopaque intervertebral metal implant according to claim 2, wherein the boundary layer has a thickness of 1.5 mm to 10.0 mm.

4. The radiopaque intervertebral metal implant according to claim 2, wherein the at least one cavity is filled with a bone replacement material selected from polymeric bioresorbable materials, polymeric bioresorbable materials containing an osteoinductive agent, bioresorbable materials containing bone-forming cells or materials which are converted to new bone under physiologic conditions.

5. The radiopaque intervertebral metal implant according to claim 1, further comprising two, three, four, five or six cavities.

6. The radiopaque intervertebral metal implant according to claim 5, wherein between 10% and 90% of the horizontal tubes terminate at one of the cavities.

7. The radiopaque intervertebral metal implant according to claim 1, wherein the intervertebral implant has a porosity of at least 75%.

8. The radiopaque intervertebral metal implant according to claim 1, wherein a ratio of a volume of a solid implant material to a total implant surface area is between 200 μ

m and 230 μ

m.

9. The radiopaque intervertebral metal implant according to claim 1, wherein the vertical tubes of the tubular structure extend substantially along a longitudinal axis of a spinal column.

10. The radiopaque intervertebral metal implant according to claim 1, wherein the tubes have a dimension of 250 μ

m to 2,000 μ

m.

11. The radiopaque intervertebral metal implant according to claim 1, wherein the upper plane and the lower plane of the implant have at least 80 tubes per cm².

12. The radiopaque intervertebral metal implant according to claim 1, wherein the vertical tubes and/or the horizontal tubes don'"'"'t change their inner diameter on their way through the implant.

13. The radiopaque intervertebral metal implant according to claim 1, wherein the implant is manufactured in one continuous piece.

14. The radiopaque intervertebral metal implant according to claim 1, wherein the implant is selected from the group consisting of cervical cages, thoracic cages, lumbar cages, artificial intervertebral disks and implants for the fusion of natural and artificial vertebrae.

15. The radiopaque intervertebral metal implant according to claim 1, wherein a ratio of a volume of a material of the implant to a volume of the tubes ranges from 10 vol. %:

90 vol. % to 20 vol. %;

80 vol. %.

16. The radiopaque intervertebral metal implant according to claim 1, wherein the metal implant is a titanium implant.

17. A radiopaque intervertebral metal implant for fusion of two bridged vertebral bodies comprises:

an upper plane for contacting an upper vertebral body;

a lower plane for contacting a lower vertebral body;

at least one cavity in the center of the implant extending from the upper plane to the lower plane, wherein the at least one cavity is surrounded by a boundary layer with a tubular structure comprising vertical tubes and horizontal tubes;

wherein the vertical tubes run from the upper plane to the lower plane; and

the horizontal tubes run in a substantially horizontal direction throughout one side of the intervertebral implant straight to the opposite side of the intervertebral implant thereby interconnecting the vertical tubes, the horizontal tubes are parallel to each other or are grouped into groups of parallel horizontal tubes so that X-ray spectra or radiographs are conductable through the horizontal tubes, and wherein all surfaces of the intervertebral metal implant have a roughness of 6.0 Ra to 8.5 Ra.

18. The radiopaque intervertebral metal implant according to claim 17, wherein the boundary layer surrounds the at least one cavity completely on the upper plane and the lower plane.

19. The radiopaque intervertebral metal implant according to claim 17, wherein the at least one cavity comprises two, three, four, five or six cavities.

20. The radiopaque intervertebral metal implant according to claim 17, wherein the boundary layer has a thickness of 1.5 mm to 10.0 mm.

21. The radiopaque intervertebral metal implant according to claim 17, wherein the intervertebral implant has a porosity of at least 75%.

22. The radiopaque intervertebral metal implant according to claim 17, wherein a ratio of a volume of a solid implant material to a total implant surface area is between 200 μ

m and 230 μ

m.

23. The radiopaque intervertebral metal implant according to claim 17, wherein the vertical tubes of the tubular structure extend substantially along a longitudinal axis of a spinal column.

24. The radiopaque intervertebral metal implant according to claim 17, wherein between 10% and 90% of the horizontal tubes terminate at the at least one cavity.

25. The radiopaque intervertebral metal implant according to claim 17, wherein the at least one cavity is filled with a bone replacement material selected from polymeric bioresorbable materials, polymeric bioresorbable materials containing an osteoinductive agent, bioresorbable materials containing bone-forming cells or materials which are converted to new bone under physiologic conditions.

26. The radiopaque intervertebral metal implant according to claim 17, wherein the tubes have a dimension of 250 μ

m to 2,000 μ

m.

27. The radiopaque intervertebral metal implant according to claim 17, wherein the upper plane and the lower plane of the implant have at least 80 tubes per cm².

28. The radiopaque intervertebral metal implant according to claim 17, wherein the vertical tubes and/or the horizontal tubes don'"'"'t change their inner diameter on their way through the implant.

29. The radiopaque intervertebral metal implant according to claim 17, wherein the boundary layer is manufactured in one continuous piece.

30. The radiopaque intervertebral metal implant according to claim 17, wherein the implant is selected from the group consisting of cervical cages, thoracic cages, lumbar cages, artificial intervertebral disks and implants for the fusion of natural and artificial vertebrae.

31. The radiopaque intervertebral metal implant according to claim 17, wherein the implant has a ratio of a volume of a material of the implant to a volume of the tubes ranges from 10 vol. %:

90 vol. % to 20 vol. %;

80 vol. %.

32. The radiopaque intervertebral metal implant according to claim 17, wherein a ratio of a volume of the at least one cavity to an overall volume of the implant within the boundary layer ranges from 1:

2 to 1;

1.

33. The radiopaque intervertebral metal implant according to claim 17, wherein the metal implant is a titanium implant.