Fenestrated implant

• US 10,426,533 B2
• Filed: 05/06/2013
• Issued: 10/01/2019
• Est. Priority Date: 05/04/2012
• Status: Active Grant

• Current Assignee: SI-Bone, Incorporated
• Original Assignee: SI-Bone, Incorporated
• Inventors: Mauldin, Richard G., Yerby, Scott A., Reiley, Mark A., Schneider, Bret W.
• Primary Examiner(s): Ramana, Anu
• Application Number:
  US13/888,249
• Publication Number:
  US 20130296953A1
• Time in Patent Office: 2,339 Days
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1664 for the hip
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1697 specially adapted for wire insertion
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• CPC Class Codes: A61B 17/7055 connected to sacrum, pelvis or skull
• CPC Class Codes: A61B 17/84 Fasteners therefor or fasteners being internal fixation devices
• CPC Class Codes: A61B 17/8897 Guide wires or guide pins
• CPC Class Codes: A61F 2002/30995 for sacro-iliac joints

Abstract

The present invention relates generally to implants used in medical procedures such as bone fixation or fusion. More specifically, this application relates to fenestrated implants used in bone fixation or fusion.

Claims

1. An implant for bone fixation, the implant comprising:

an elongate body having a longitudinal axis, a distal end, a proximal end, a rectilinear cross section transverse to the longitudinal axis having three or four sides, and a plurality of faces, each of the plurality of faces formed from a wall with a thickness between 1 mm and 5 mm in thickness, and each face having a width and a plurality of fenestrations, the plurality of fenestrations each having a diameter that is between about 0.2 to about 0.5 of the width of its associated face, the elongate body having a central lumen located along the longitudinal axis and configured to receive a guide pin, wherein each of the plurality of fenestrations reach and provide access to the central lumen, wherein a concentration or number of fenestrations is higher in a distal half of the elongate body than in a proximal half, wherein the distal end of the elongate body is tapered to facilitate implantation into the bone, and wherein the elongate body has a bending strength or a shear strength of at least 0.5 relative to a reference elongate body with identical dimensions and material composition but without any fenestrations.

2. The implant of claim 1, wherein the distal end of the elongate body is formed into one or more cutting edges.

3. The implant of claim 1, wherein the fenestrations are located on a distal portion of the elongate body that is configured to be implanted within the sacrum of a patient while the proximal portion of the elongate body that is configured to be implanted within the ilium is free from fenestrations.

4. The implant of claim 1, wherein the fenestrations are arranged in a staggered pattern.

5. The implant of claim 1, further comprising a cap on the proximal end of the elongate body, the cap having a hole sized to receive a guide pin.

6. The implant of claim 1, wherein the elongate body has an inner surface and an outer surface that are porous.

7. The implant of claim 1, wherein the elongate body has an inner surface and an outer surface that are roughened.

8. The implant of claim 1, wherein the elongate body has an inner surface and an outer surface that are treated with a plasma coating.

9. The implant of claim 1, wherein the elongate body has an inner surface and an outer surface that are coated with a biologic aid.

10. The implant of claim 9, wherein the biologic aid is a bone morphogenetic protein.

11. An implant for bone fixation, the implant comprising:

an elongate body having a longitudinal axis, a distal end, a proximal end, a rectilinear cross section transverse to the longitudinal axis having three or four sides, and a plurality of faces, each of the plurality of faces having a width and a plurality of fenestrations, the plurality of fenestrations each having a diameter that is between about 0.2 to about 0.5 of the width of its associated face, the elongate body having a central lumen located along the longitudinal axis and configured to receive a guide pin, wherein each of the plurality of fenestrations reach and provide access to the central lumen, wherein a concentration or number of fenestrations is higher in a distal half of the elongate body than in a proximal half, wherein the distal end of the elongate body is tapered to facilitate implantation into the bone, and wherein the elongate body has a bending strength or a shear strength of at least 0.5 relative to a reference elongate body with identical dimensions and material composition but without any fenestrations.

12. The implant of claim 11, wherein the distal end of the elongate body is formed into one or more cutting edges.

13. The implant of claim 11, wherein the fenestrations are located on a distal portion of the elongate body that is configured to be implanted within the sacrum of a patient while the proximal portion of the elongate body that is configured to be implanted within the ilium is free from fenestrations.

14. The implant of claim 11, wherein the fenestrations are arranged in a staggered pattern.

15. The implant of claim 11, further comprising a cap on the proximal end of the elongate body, the cap having a hole sized to receive a guide pin.

16. The implant of claim 11, wherein the elongate body has an inner surface and an outer surface that are porous.

17. The implant of claim 11, wherein the elongate body has an inner surface and an outer surface that are roughened.

18. The implant of claim 11, wherein the elongate body has an inner surface and an outer surface that are treated with a plasma coating.

19. The implant of claim 11, wherein the elongate body has an inner surface and an outer surface that are coated with a biologic aid.

20. The implant of claim 19, wherein the biologic aid is a bone morphogenetic protein.