Implantable medical devices

Patent metadata

Field	Value
Publication number	US-9399086-B2
Application number	US-50885609-A
Country	US
Kind code	B2
Filing date	Jul 24, 2009
Priority date	Jul 24, 2009
Publication date	Jul 26, 2016
Grant date	Jul 26, 2016

Abstract

Implantable medical devices are provided. In one embodiment, a device includes a body having an external surface defining an outer profile of the device. The body includes a porous matrix including a series of interconnected macropores defined by a plurality of interconnected struts each including a hollow interior. A filler material substantially fills at least a portion of the series of interconnected macropores. The external surface of the body includes a plurality of openings communicating with the hollow interior of at least a portion of the plurality of interconnected struts. In a further aspect of this embodiment, the external surface includes exposed areas of the filler material and porous matrix in addition to the exposed openings. In another aspect, the porous matrix is formed from a bioresorbable ceramic and the filler material is a biologically stable polymeric material. Still, other aspects related to this and other embodiments are also disclosed.

First claim

What is claimed is:

1. An implantable medical device, comprising:
a body including an external surface defining an outer profile of said device, said body further including:
a porous matrix having a compressive strength of about 10 MPa and including a series of interconnected macropores defined by a plurality of interconnected struts, said struts each including a hollow interior;
a filler material substantially filling at least a portion of said series of interconnected macropores, said filler material comprising a polymeric material selected from the group consisting of polyetheretherketone (PEEK), carbon-reinforced PEEK, and polyetherketoneketone (PEKK); and
a plurality of openings extending through at least a portion of said external surface and communicating with said hollow interior of at least a portion of said plurality of interconnected struts.

2. The device of claim 1 , wherein said porous matrix is formed of at least one of an osteoconductive material and an osteoinductive material configured to be capable of undergoing a bone remodeling process.

3. The device of claim 1 , wherein said porous matrix comprises a calcium based ceramic material.

4. The device of claim 1 , wherein said porous matrix comprises Skelite®.

5. The device of claim 1 , wherein said plurality of interconnected struts each have a hollow interior upon implantation of said device.

6. The device of claim 1 , wherein said hollow interiors of said plurality of interconnected struts are interconnected and in communication with one another.

7. The device of claim 6 , wherein said hollow interiors are isolated from said series of interconnected macropores before said filler material fills said series of interconnected macropores.

8. The device of claim 1 , wherein said body includes a tool engagement portion substantially free of said porous matrix, said tool engagement portion being at least partially surrounded by said porous matrix and filler material and including a threaded aperture formed therein.

9. An implantable medical device, comprising:
a body including an external surface defining an outer profile of said device, said body further including:
a porous matrix including a series of interconnected macropores defined by a plurality of interconnected struts, said struts each including a hollow interior, the porous matrix having a compressive strength of about 10 MPa and comprising a calcium based ceramic material defined by a compound that includes elements of calcium, oxygen and phosphorous, wherein a portion of at least one of said elements is substituted with an element having an ionic radius of about 0.1 to about 0.6 Å;
a filler material substantially filling at least a portion of said series of interconnected macropores while not filling the hollow interior of each strut, the filler material comprising a polymeric material selected from the group consisting of polyetheretherketone (PEEK), carbon-reinforced PEEK, and polyetherketoneketone (PEKK); and
a plurality of openings extending through at least a portion of said external surface and communicating with said hollow interior of at least a portion of said plurality of interconnected struts.

10. The device of claim 9 , wherein said hollow interiors of said plurality of interconnected struts are interconnected and in communication with one another.

11. The device of claim 10 , wherein said hollow interiors are isolated from said series of interconnected macropores.

12. The device of claim 9 , wherein said hollow interiors of said plurality of interconnected struts are substantially free of said filler material.

13. The device of claim 9 , wherein said at least a portion of said external surface is defined by said plurality of openings, exposed areas of said porous matrix, and exposed areas of said filler material.

14. The device of claim 13 , wherein said portion of said external surface extends around said outer profile of said device.

15. The device of claim 13 , wherein one or more of said exposed areas of said porous matrix surrounds one or more of said plurality of openings and isolates said openings from an adjacent one of said exposed areas of said filler material.

16. The device of claim 13 , wherein said ceramic material is bioresorbable and said polymeric material is biologically stable.

17. The device of claim 16 , wherein said exposed areas of said porous matrix promote cellular attachment and osteoconduction at said external surface and said plurality of openings promotes bone and tissue ingrowth into said body.

18. The device of claim 9 , wherein said compound has the formula:
(Ca) i {( P1-x-y-z B x C y D z )O j } 2 wherein B, C and D are selected from those elements having an ionic radius of approximately 0.1 to 0.4 Å;
x is greater than or equal to zero but less than 1;
y is greater than or equal to zero but less than 1;
z is greater than or equal to zero but less than 1;
x+y+z is greater than zero but less than 1;
i is greater than or equal to 2 but less than or equal to 4; and
j is equal 4−δ, where δ is greater than or equal to zero but less than or equal to 1.

19. The device of claim 18 , wherein said polymeric material is polyetheretherketone.

20. The device of claim 18 , wherein one of B, C and D is silicon.

21. The device of claim 9 , wherein said filler material is infused throughout and substantially fills each one of said series of interconnected macropores.

22. The device of claim 9 , wherein said porous matrix is formed of at least one of an osteoconductive material and an osteoinductive material configured to be capable of undergoing a bone remodeling process.

23. The device of claim 9 , wherein said interconnected struts have a hollow interior upon implantation of the device.

24. The device of claim 9 , wherein said element having an ionic radius of about 0.1 to about 0.6 Å is silicon.

25. The device of claim 9 , wherein said element having an ionic radius of about 0.1 to about 0.6 Å is boron.

26. The device of claim 9 , wherein said porous matrix comprises a plurality of coats of said calcium based ceramic material to provide said porous matrix with the compressive strength of about 10 MPa.

27. The device of claim 26 , wherein said plurality of coats comprises several coats having a solids loading of said calcium based ceramic material of up to about 30 percent by volume.

28. The device of claim 26 , wherein said plurality of interconnected struts each have a thickness of about 10 microns to about 100 microns.

29. The device of claim 26 , wherein said plurality of coats comprises a first set having solids loading up to about 30 percent by volume and a second set having solids loading below about 20 percent by volume.

30. The device of claim 9 , wherein said filler material comprises one or more polar functional groups selected from a group consisting of an ether and an ester.

31. The device of claim 9 , wherein said filler material comprises oleic acid.

32. An implantable medical device, comprising a body including an external surface defining an outer profile of said device, said external surface including one or more exposed areas of a porous matrix including one or more interconnected openings defined by a plurality of interconnected struts, said struts each including a hollow interior upon implanta

Assignees

• Melkent Anthony J
• Thoren Brian R
• Smith Timothy J N
• Grant Ian D
• Dunkley Ian R
• Warsaw Orthopedic Inc

Inventors

• Melkent Anthony J
• Thoren Brian R
• Smith Timothy J N
• Grant Ian D
• Dunkley Ian R

Classifications

• C04B41/4586

  Non-chemical aspects relating to the substrate being coated or impregnated · CPC title

• A61L2400/08

  Methods for forming porous structures using a negative form which is filled and then removed by pyrolysis or dissolution · CPC title

• A61L31/121 Primary

  having an inorganic matrix · CPC title

• B29C2045/0058

  removing material · CPC title

• A61L27/56 Primary

  Porous materials, {e.g. foams or sponges} · CPC title