Porous devices and methods of producing the same

• US 10,405,962 B2
• Filed: 12/26/2017
• Issued: 09/10/2019
• Est. Priority Date: 06/26/2014
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Vertera, Inc. (Nuvasive Incorporated)
• Inventors: Chang, Wei-Hsiang, Laffoon, Stephen Lee, Lee, Christopher S. D., Safranski, David Lee
• Primary Examiner(s): Stewart, Jason-Dennis N
• Application Number:
  US15/854,746
• Publication Number:
  US 20180193125A1
• Time in Patent Office: 623 Days
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/50 specially adapted for specific body parts; specially adapted for specific clinical applications
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2002/0081 directly machined on the prosthetic surface, e.g. holes, grooves A61F2/30771 takes precedence
• CPC Class Codes: A61F 2002/0086 for preferentially controlling or promoting the growth of specific types of cells or tissues
• CPC Class Codes: A61F 2210/0071 thermoplastic
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 2430/38 for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: B29C 44/0461 by having different chemical compositions in different places, e.g. having different concentrations of foaming agent, feeding one composition after the other
• CPC Class Codes: B29C 44/3415 Heating or cooling
• CPC Class Codes: B29C 67/202 comprising elimination of a solid or a liquid ingredient
• CPC Class Codes: B29K 2071/00 Use of polyethers , e.g. PEEK, i.e. polyether-etherketone or PEK, i.e. polyetherketone or derivatives thereof, as moulding material
• CPC Class Codes: B29L 2031/753 Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: B29L 2031/7546 : Surgical equipment
• CPC Class Codes: C08J 2201/0446 : Elimination of NaCl only
• CPC Class Codes: C08J 2371/00 : Characterised by the use of polyethers obtained by reactions forming an ether link in the main chain; Derivatives of such polymers
• CPC Class Codes: C08J 9/0085 : Use of fibrous compounding ingredients C08J9/0076 takes precedence
• CPC Class Codes: C08J 9/26 : by elimination of a solid phase from a macromolecular composition or article, e.g. leaching out
• CPC Class Codes: C08L 71/00 : Compositions of polyethers obtained by reactions forming an ether link in the main chain of polyacetals C08L59/00; of epoxy resins C08L63/00; of polythioether-ethers C08L81/02; of polyether-sulfones C08L81/06; Compositions of derivatives of such polymers

Abstract

A method for making a polymer with a porous layer from a solid piece of polymer is disclosed. In various embodiments, the method includes heating a surface of a solid piece of polymer to a processing temperature and holding the processing temperature while displacing a porogen layer through the surface of the polymer to create a matrix layer of the solid polymer body comprising the polymer and the porogen layer. In at least one embodiment, the method also includes removing at least a portion of the layer of porogen from the matrix layer to create a porous layer of the solid piece of polymer.

Claims

1. A medical device for promoting tissue ingrowth, the medical device comprising a thermoplastic body defining a main body and a first porous surface layer, the first porous surface layer formed from a plurality of pores, each of the pores extending a defined distance from a first face into the thermoplastic body, wherein:

the main body comprises a first particular percentage of hydroxyl groups; and

the first porous surface layer comprises a second particular percentage of hydroxyl groups, wherein the second particular percentage of hydroxyl groups is greater than the first particular percentage of hydroxyl groups.

2. The medical device of claim 1, further comprising at least one marker for detecting the medical device on an x-ray.

3. The medical device of claim 2, wherein the at least one marker comprises a radiopaque metal.

4. The medical device of claim 3, wherein the radiopaque metal is tantalum.

5. The medical device of claim 2, wherein the at least one marker is substantially cylindrical, rectangular, triangular, or conical.

6. The medical device of claim 5, where the at least one marker is substantially cylindrical.

7. The medical device of claim 6, wherein the substantially cylindrical marker can be inserted into a portion of the thermoplastic body.

8. The medical device of claim 6, wherein the substantially cylindrical maker can be inserted into a portion of the thermoplastic body and extends vertically through the thermoplastic body.

9. The medical device of claim 2, wherein the at least one marker comprises a radiolucent material.

10. The medical device of claim 9, wherein the at least one marker further comprises a radiopaque material.

11. The medical device of claim 1, wherein the thermoplastic body further defines a second porous surface layer formed from a plurality of pores, each of the pores extending about the defined distance from a second face into the thermoplastic body.

12. The medical device of claim 11, wherein the defined distance is approximately 0.5 mm to 1.0 mm.

13. The medical device of claim 12, wherein the defined distance is approximately 0.7 mm.

14. The medical device of claim 11, wherein:

the medical device further comprises at least one marker for detecting the medical device on x-ray; and

the at least one marker extends from the top face of the porous surface through the thermoplastic body to the bottom face of the second porous surface.

15. The medical device of claim 14, wherein the at least one marker is positioned so that it extends vertically through the medical device and the end-surfaces of the marker are substantially flush with porous faces of the thermoplastic body.

16. The medical device of claim 1, wherein the thermoplastic body comprises polyetheretherketone (PEEK).

17. The medical device of claim 1, wherein:

the thermoplastic body main body comprises a first particular carbon to oxygen atomic ratio; and

the first porous surface layer comprises a second particular carbon to oxygen atomic ratio, wherein the second particular carbon to oxygen atomic ratio is substantially the same as the first particular carbon to oxygen atomic ratio.

18. The medical device of claim 1, wherein the expulsion resistance of the medical device is at least about 1.5 times greater than the expulsion resistance of a medical device of similar material, with no porous layers.

19. The medical device of claim 1, wherein the first porous surface layer has a particular wettability, and wherein the particular wettability is greater than a wettability of the thermoplastic body main body.

20. The medical device of claim 1, wherein:

an interconnectivity between the plurality of pores is at least 99%; and

an interfacial shear strength between the first porous surface layer and the thermoplastic body main body is at least 17 MPa.