Implantable medical devices and methods for making same

• US 20040193285A1
• Filed: 03/28/2003
• Published: 09/30/2004
• Est. Priority Date: 03/28/2003
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Li, Yufu, Yuan, Jenny J., Roller, Mark B.
• Granted Patent: US 7,572,298 B2
• Time in Patent Office: Days
• US Class Current: 623/23.75
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• 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 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials

Abstract

The present invention is directed to an implantable medical device, the device contraining a body and a first lubricated surface for contacting tissue, or a second surface of the device, or a surface of a second medical device, the implantable device fabricated at least in part from a biocompatible, biodegradable composition, the composition containing a biocompatible, biodegradable polymer and a biocompatible, biodegradable wax, wherein the concentration of the wax at the first lubricated surface of the implantable device is greater than the concentration of the wax in the body of the implantable device, and to methods of making the device wherein the device is heated to a temperature greater than the melting point of the wax, greater than the glass transition temperature of the polymer, and lower than melting point of the polymer, thereby providing the lubricated surface.

Claims

1. An implantable medical device, comprising:

a body and a first lubricated surface for contacting tissue, or a second surface of said device, or a surface of a second medical device, the implantable device comprising a biocompatible, biodegradable composition, the composition comprising a biocompatible, biodegradable polymer and a biocompatible, biodegradable wax, wherein the concentration of the wax at the first lubricated surface of the implantable device is greater than the concentration of the wax in the body of the implantable device, thereby providing the lubricated surface.

2. The medical device of claim 1 wherein the biodegradable polymer is selected from the group consisting of aliphatic polyesters, poly(amino acids), copoly(ether-esters), polyalkylenes oxalates, polyamides, poly(ethylene glycol), poly(iminocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amine groups, poly(anhydrides), polyphosphazenes, biopolymers and copolymers thereof.

3. The medical device of claim 2 wherein the aliphatic polyester is selected from the group consisting of homopolymers and copolymers of lactide, glycolide, epsilon-caprolactone, para-dioxanone, trimethylene carbonate, alkyl derivatives of trimethylene carbonate and monoglyceride polyesters.

4. The medical device of claim 3 wherein the aliphatic polyester comprises a copolymer of from about 80 to 99 mole percent lactide and glycolide.

5. The medical device of claim 4 wherein the aliphatic polyester has an inherent viscosity of greater than about 2.0 g/dl as measured in chloroform at 25°

C.

6. The medical device of claim 1 wherein the biodegradable wax is selected from the group consisting of aliphatic polyesters, poly(amino acids), copoly(ether-esters), polyalkylenes oxalates, polyamides, poly(ethylene glycol), poly(iminocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amine groups, poly(anhydrides), polyphosphazenes, biopolymers and copolymers thereof

7. The medical device of claim 6 wherein the aliphatic polyester wax is selected from the group consisting of homopolymers and copolymers of lactide, glycolide, epsilon-caprolactone, para-dioxanone, trimethylene carbonate, alkyl derivatives of trimethylene carbonate and monoglyceride polyesters.

8. The medical device of claim 7 wherein the aliphatic polyester wax comprises a copolymer of from about 90 to about 10 mole percent epsilon-caprolactone and glycolic acid.

9. The medical device of claim 8 wherein the wax has an inherent viscosity of less than about 0.7 g/dl as measured in chloroform at 25°

C.

10. The medical device of claim 1 further comprising an inorganic filler material.

11. The medical device of claim 10 wherein said inorganic filler material is selected from the group consisting of mono-, di-, tri-, α

-tri-, β

-tri-, and tetra-calcium phosphate, hydroxyapatite, fluoroapatites, calcium sulfates, calcium fluorides, calcium oxides, calcium carbonates, magnesium calcium phosphates and bio-glasses.

12. The medical device of claim 11 selected from the group consisting of reinforcing rods, plates, cages, screws, pins, anchors, expanding sleeves and expanding collars.

13. The medical device of claim 12 wherein the anchor comprises a radially-expandable sheath and a sheath-expanding element

14. A method for making an implantable medical device, the device comprising a body and a first lubricated surface for contacting tissue, or a second surface of the device, or a surface of a second medical device, the implantable device comprising a biocompatible, biodegradable composition, the composition comprising a biocompatible, biodegradable polymer and a biocompatible, biodegradable wax, wherein the concentration of the wax at the first lubricated surface of the implantable device is greater than the concentration of the wax in the body of the implantable device, wherein the device is heated to a temperature greater than the melting point of the wax, greater than the glass transition temperature of the polymer, and lower than melting point of the polymer, thereby providing the lubricated surface.

15. The method of claim 14 wherein the biodegradable polymer is selected from the group consisting of aliphatic polyesters, poly(amino acids), copoly(ether-esters), polyalkylenes oxalates, polyamides, poly(ethylene glycol), poly(iminocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amine groups, poly(anhydrides), polyphosphazenes, biopolymers and copolymers thereof.

16. The method of claim 15 wherein the aliphatic polyester is selected from the group consisting of homopolymers and copolymers of lactide, glycolide, epsilon-caprolactone, para-dioxanone, trimethylene carbonate, alkyl derivatives of trimethylene carbonate and monoglyceride polyesters.

17. The method of claim 14 wherein the aliphatic polyester comprises a copolymer of from about 80 to 99 mole percent lactide and glycolide.

18. The method of claim 17 wherein the aliphatic polyester has an inherent viscosity of greater than about 2.0 g/dl as measured in chloroform at 25°

C.

19. The method of claim 14 wherein the biodegradable wax is selected from the group consisting of aliphatic polyesters, poly(amino acids), copoly(ether-esters), polyalkylenes oxalates, polyamides, poly(ethylene glycol), poly(iminocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amine groups, poly(anhydrides), polyphosphazenes, biopolymers and copolymers thereof

20. The method of claim 19 wherein the aliphatic polyester wax is selected from the group consisting of homopolymers and copolymers of lactide, glycolide, epsilon-caprolactone, para-dioxanone, trimethylene carbonate, alkyl derivatives of trimethylene carbonate and monoglyceride polyesters.

21. The method of claim 20 wherein the aliphatic polyester wax comprises a copolymer of from about 90 to about 10 mole percent epsilon-caprolactone and glycolic acid.

22. The medical device of claim 21 wherein the wax has an inherent viscosity of less than about 0.7 g/dl as measured in chloroform at 25°

C.

23. The method of claim 14 further wherein said composition further comprises an inorganic filler material.

24. The method of claim 23 wherein said inorganic filler material is selected from the group consisting of mono-, di-, tri-, α

-tri-, β

-tri-, and tetra-calcium phosphate, hydroxyapatite, fluoroapatites, calcium sulfates, calcium fluorides, calcium oxides, calcium carbonates, magnesium calcium phosphates and bio-glasses.

25. The method of claim 14 wherein said device is selected from the group consisting of reinforcing rods, plates, cages, screws, pins, anchors, expanding sleeves and expanding collars.

26. The method of claim 25 wherein said anchor comprises a radially-expandable sheath and a sheath-expanding element

27. The method of claim 14 wherein said temperature is at least 10°

C. lower than the melting temperature of said polymer.

28. The method of claim 14 wherein said temperature is at least 20°

C. lower than the melting temperature of said polymer.