Porous tissue ingrowth structure

• US 9,724,203 B2
• Filed: 03/13/2014
• Issued: 08/08/2017
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: SMed TA/TD, LLC. (Sites Medical LLC)
• Original Assignee: SMed TA/TD, LLC. (Sites Medical LLC)
• Inventors: Nebosky, Paul S., Stalcup, Gregory C., Knapp, Troy D.
• Primary Examiner(s): Robert, Eduardo C
• Assistant Examiner(s): Carter, Tara R
• Application Number:
  US14/209,407
• Publication Number:
  US 20140277461A1
• Time in Patent Office: 1,244 Days
• Field of Search: 606246-249, 623 2374, 623 1711- 1716, 264273, 264413, 264414
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• 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 2002/30011 differing in porosity
• CPC Class Codes: A61F 2002/30014 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2002/30784 Plurality of holes
• CPC Class Codes: A61F 2002/3079 Stepped or enlarged apertures, e.g. having discrete diameter changes
• CPC Class Codes: A61F 2002/30807 Plurality of blind bores
• CPC Class Codes: A61F 2002/30813 Stepped or enlarged blind bores, e.g. having discrete diameter changes
• CPC Class Codes: A61F 2002/30841 Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30915 made of a stack of bonded perforated sheets, grids or wire meshes
• CPC Class Codes: A61F 2002/3092 having an open-celled or open-pored structure
• CPC Class Codes: A61F 2002/30971 Laminates, i.e. layered products
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor

Abstract

A three-dimensional scaffold for a medical implant includes a plurality of layers bonded to each other. Each layer has a top surface and a bottom surface and a plurality of pores extending from the top surface to the bottom surface. Each layer has a first pore pattern of the pores at the top surface and a different, second pore pattern at the bottom surface. Adjacent surfaces of at least three adjacent layers have a substantially identical pore pattern aligning to interconnect the pores of the at least three adjacent layers to form a continuous porosity through the at least three adjacent said layers.

Claims

1. A three-dimensional scaffold for a medical implant, the scaffold comprising a plurality of layers bonded to each other and each said layer having a top surface and a bottom surface, each of said layers having a plurality of pores extending through said top surface to said bottom surface, each said layer having a first pore pattern of said plurality of pores at said top surface and a different, second pore pattern at said bottom surface, said first pore pattern and said second pore pattern partially overlapping within each said layer, wherein adjacent said surfaces of at least three adjacent said layers having a substantially identical pore pattern aligning to interconnect said plurality of pores of said at least three adjacent layers and form a continuous porosity through said at least three adjacent said layers.

2. The scaffold according to claim 1, each of said plurality of layers having at least one transition point where a geometry of said plurality of pores extending between said top surface and said bottom surface transitions from said first pore pattern to at least one said second pore pattern, said at least one transition point being at a position in a range between approximately 0.05 and 0.95 through a thickness of said respective layer.

3. The scaffold according to claim 2, wherein said at least one transition point is two transition points.

4. The scaffold according to claim 3, said thickness of each of said plurality of layers being in a range between approximately 0.0001 and 10 inches.

5. The scaffold according to claim 2, wherein different said pores of said plurality of layers have a plurality of different geometries.

6. The scaffold according to claim 1, wherein said plurality of layers of the scaffold include at least one interlocking feature allowing adjacent said layers to nest together.

7. The scaffold according to claim 6, wherein said interlocking feature is at least one undercut in at least one of said plurality of layers into which extends one of a strut of an adjacent one of said plurality of layers and a protrusion extending from said adjacent one of said plurality of layers.

8. A medical implant, comprising:

a main body; and

at least one scaffold coupled with said main body, said at least one scaffold including a plurality of layers bonded to each other, each said layer having a top surface and a bottom surface and a plurality of pores extending through said top surface to said bottom surface, each said layer having a first pore pattern of said plurality of pores at said top surface and a different, second pore pattern at said bottom surface, said first pore pattern and said second pore pattern partially overlapping within each said layer, wherein adjacent said surfaces of at least three adjacent said layers having a substantially identical pore pattern aligning to interconnect said plurality of pores of said at least three layers and form a continuous porosity through said at least three adjacent said layers.

9. The medical implant according to claim 8, wherein said main body is formed of a solid material.

10. The medical implant according to claim 9, wherein said solid material is one of an implantable polymer material and a solid metal.

11. The medical implant according to claim 10, wherein said implantable polymer material is polyetheretherketone (PEEK).

12. The medical implant according to claim 8, said at least one scaffold being formed of an implantable metal material.

13. The medical implant according to claim 8, wherein the medical implant is an implantable spinal device.

14. The medical implant according to claim 13, said at least one scaffold further comprising a plurality of anti-back out grooves.

15. The medical implant according to claim 14, said at least one scaffold further comprising a solid, stiffening layer, wherein said at least one scaffold is at least two scaffolds including at least one first scaffold and at least one second scaffold, said stiffening layer being positioned between said at least one first scaffold and said at least one second scaffold, sealing said at least one first scaffold from said at least one second scaffold.

16. The medical implant according to claim 15, said stiffening layer being formed from one of a biocompatible metal and a polymeric material.

17. The medical implant according to claim 16, wherein said stiffening layer has a pair of opposing surface, at least one of said opposing surfaces of said stiffening layer including a plurality of surface pores which do not extend through an entire thickness of said stiffening layer.

18. The medical implant according to claim 17, wherein said opposing surfaces of said stiffening layer include first surface and a second surface, each of said first surface and said second surface of said stiffening layer including a plurality of surface pores, said stiffening layer including a solid region between said surface pores of said opposing surfaces to prevent flow through from said first surface of said stiffening layer to said second surface of said stiffening layer.

19. The medical implant according to claim 18, further comprising at least one alignment pin for holding said stiffening layer in position.

20. The medical implant according to claim 8, wherein said plurality of layers is at least four layers and one layer of said at least four layers is configured such that a plurality of solid regions of said one layer abut said plurality of pores of an adjacent one of said plurality of layers to prevent flow through between said one layer and an adjacent layer of said at least four layers.

21. A method of manufacturing a scaffold for a medical implant, the method comprising the steps of:

providing a plurality of layers of a biocompatible material having a top surface and a bottom surface;

creating a plurality of pores in said plurality of layers of biocompatible material such that each of said layers has a plurality of pores extending through said top surface to said bottom surface, a first pore pattern of said plurality of pores at said top surface of each of said layers being different than a second pore pattern of said bottom surface of each of said layers, and said first pore pattern and said second pore pattern partially overlap within each said layer; and

bonding said plurality of layers together such that adjacent said surfaces of at least three adjacent said layers have a substantially identical pore pattern aligning to interconnect said plurality of pores of said at least three layers forming a continuous porosity through said at least three adjacent said layers.