Tissue repair and replacement

• US 9,504,574 B2
• Filed: 02/25/2015
• Issued: 11/29/2016
• Est. Priority Date: 08/22/2003
• Status: Expired due to Fees

• Current Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Original Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Inventors: Farrar, David, Brown, Malcolm, Hall, Michael, Brunelle, John Eric, Cotton, Nicholas John, Berube, Rod, Lipchitz, John
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US14/631,738
• Publication Number:
  US 20150164643A1
• Time in Patent Office: 643 Days
• Field of Search: 623/16.11, 623/23.75
• US Class Current: 1/1
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61L 24/0036 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 24/0042 Materials resorbable by the body
• CPC Class Codes: A61L 24/0063 Phosphorus containing materials, e.g. apatite
• CPC Class Codes: A61L 24/0084 containing fillers of phosphorus-containing inorganic compounds, e.g. apatite
• CPC Class Codes: A61L 24/0094 containing macromolecular fillers
• CPC Class Codes: A61L 27/14 Macromolecular materials
• CPC Class Codes: A61L 27/425 of phosphorus containing material, e.g. apatite
• CPC Class Codes: A61L 27/46 with phosphorus-containing inorganic fillers
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body

Abstract

Tissue fixation devices are provided. The devices include a first component and a second component, the components having different rates of in vivo degradation. The first component and second component are arranged so that, upon degradation of one of the components, the other component provides a scaffold into which bone can grow.

Claims

1. A method of tissue repair or replacement, comprising:

implanting in a patient a tissue repair or replacement device having at least a first and a second components, the first component having a higher rate of in vivo degradation than the second component, and the first and second components being arranged relative to each other so that, after implantation of the device, the first component degrades in vivo leaving a scaffold formed of the second component, the scaffold having pores into which tissue can infiltrate,

wherein a portion of the first or second component of the tissue replacement or repair device covers the entire outer surface of the other component except in defined areas where ribs of a production mold contacted the outer surface of the covered component of the tissue replacement or repair device.

2. The method of claim 1, wherein the scaffold has a pore size of about 20-2000 microns.

3. The method of claim 1, wherein the scaffold has a porosity of about 10-90%.

4. The method of claim 1, wherein one of the first and second components of the tissue repair or replacement device comprises a ceramic.

5. The method of claim 4, wherein the other component of the implanted tissue repair or replacement device comprises a polymer.

6. The method of claim 1, wherein the first component of the tissue repair or replacement device comprises ceramic and the second component comprises polymer.

7. The method of claim 1, wherein there is at least an 8 week difference between the rate of in vivo degradation of the first and second components of the implanted tissue repair or replacement device.

8. The method of claim 4, wherein there is at least an 8 week difference between the rate of in vivo degradation of the first and second components of the implanted tissue repair or replacement device.

9. The method of claim 1, wherein the rate of in vivo degradation of the first and second components of the implanted tissue repair or replacement device differs by about 12 months to 2 years.

10. The method of claim 4, wherein the rate of in vivo degradation of the first and second components of the implanted tissue repair or replacement device differs by about 12 months to 2 years.

11. The method of claim 1, further comprising administering at least one therapeutic additive with the implantation of the tissue repair or replacement device.

12. The method of claim 11, wherein the at least one therapeutic additive is in the first and/or second component when the tissue replacement or repair device is administered to the patient.

13. The method of claim 4, wherein the polymer of the tissue replacement or repair device is selected from the group consisting of poly(a-hydroxy acids), polyhydroxyalkonates, polycarbonates, polyacetals, polyorthoesters, polyamino acids, polyphosphoesters, polyesteramides, polyfumerates, polyanhydrides, polycyanoacrylates, polyoxomers, polysaccharides, collagen, polyurethanes, and mixtures thereof.

14. The method of claim 4, wherein the polymer of the tissue replacement or repair device comprises a poly(hydroxyl acid) selected from the group consisting of polylactides, polyglycolides, polycaprolacatones, polydioxanones, and mixtures thereof.

15. The method of claim 4, wherein the polymer of the tissue replacement or repair device comprises Polyglyconate B and the ceramic of the device comprises tricalcium phosphate (TCP).

16. The method of claim 3, wherein the polymer of the tissue replacement or repair device comprises Polyglyconate B and the ceramic comprises tricalcium phosphate (TCP).

17. The method of claim 4, wherein the polymer of the tissue replacement or repair device comprises poly(lactic acid) and the ceramic comprises hydroxyapatite (HA).

18. The method of claim 3, wherein the polymer of is formed by reacting in situ a reactive monomer or oligomer.

19. The method of claim 12, wherein the reactive monomer is selected from the group consisting of cyclic esters, cyclic carbonates, divinyl ethers-diols, and disocyanatediamine.

20. The method of claim 4, wherein the portion of the first or second component of the tissue replacement or repair device covering the entire outer surface of the other component except in the defined areas forms a non-porous layer of the scaffold, wherein the non-porous layer is about 0.050 inches in thickness.

21. A method of tissue repair or replacement, comprising:

implanting into a patient a tissue repair and replacement device having at least a first component and a second component prior to implantation, the first component having a quicker in vivo degradation rate than the second component, the first component and the second component arranged about each other such that when the device is implanted, the first component degrades faster than the second component, leaving a porous tissue repair or replacement scaffold in the patient having pores for tissue ingrowth for replacement or repair;

degrading the first component within the patient;

forming by the in vivo degradation of the first component pores within the second component; and

allowing tissue ingrowth in vivo of tissue and bone into the pores of the scaffold to secure tissue and promote healing and regrowing.

22. The method of claim 21, wherein the scaffold has a pore size of about 20-2000 microns following degradation of the first component in vivo.

23. The method of claim 21, wherein the scaffold formed from degradation of the first component has a porosity of about 10-90%.

24. The method of claim 21, wherein one of the first and second components of the tissue repair or replacement device comprises a ceramic.

25. The method of claim 24, wherein the other component of the tissue repair or replacement device comprises a polymer.

26. The method of claim 21, wherein there is at least an 8 week difference between an in vivo degradation rate of the first component and an in vivo degradation rate of the second components when the tissue repair or replacement device is implanted.

27. The method of claim 21, wherein respective rates of in vivo degradation of the first component and second components differ by about 12 months to 2 years when the tissue repair or replacement device is implanted.

28. The method of claim 21, further comprising administering at least one therapeutic additive with the implantation of the tissue repair or replacement device.

29. The method of claim 28, wherein the at least one therapeutic additive is in the first and/or second component when the tissue replacement or repair device is implanted in the patient.