POROGEN COMPOSITIONS, METHODS OF MAKING AND USES

• US 20130032962A1
• Filed: 09/28/2012
• Published: 02/07/2013
• Est. Priority Date: 02/05/2010
• Status: Active Grant

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Liu, Futian, Manesis, Nicholas J., Chan, Athene Wan Chie
• Granted Patent: US 9,205,577 B2
• Time in Patent Office: Days
• US Class Current: 264/41
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61L 24/001 Use of materials characterised by their function or physical properties
• CPC Class Codes: A61L 24/0036 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/20 Polysaccharides
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 28/0034 Use of materials characterised by their function or physical properties
• CPC Class Codes: A61L 28/0053 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/041 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 31/042 Polysaccharides
• 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: A61L 31/10 Macromolecular 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
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: B29C 41/14 Dipping a core B29C41/10 takes precedence
• CPC Class Codes: B29C 41/22 Making multilayered or multicoloured articles
• CPC Class Codes: Y10T 428/2989 Microcapsule with solid core [includes liposome]

Abstract

The present specification discloses porogen compositions comprising a core material and shell material, methods of making such porogen compositions, methods of forming such porous materials using such porogen compositions, biocompatible implantable devices comprising such porous materials, and methods of making such biocompatible implantable devices.

Claims

1. A porogen composition comprising a core material and a shell material, wherein the core material comprises at least two compounds, wherein the shell material has a melting temperature that is lower than a melting temperature of the core material.

2. The porogen composition of claim 1, wherein the core material comprises a sugar or a derivative thereof, a polysaccharide sugar or a derivative thereof, a composite thereof, or a combination thereof.

3. The porogen composition of claim 1, wherein the core material comprises sucrose and starch.

4. The porogen composition of claim 3, wherein the shell material comprises polyethylene glycol.

5. The porogen composition of claim 3, wherein the porogen composition comprises about 35% to about 50% sucrose, about 10% to about 15% starch, and about 40% to 50% polyethylene glycol, by weight.

6. The porogen composition of claim 5, wherein the porogen composition comprises about 45% sucrose, about 10% starch, and about 45% polyethylene glycol, by weight.

7. The porogen composition of claim 5, wherein the porogen composition comprises about 40% sucrose, about 15% starch, and about 45% polyethylene glycol, by weight.

8. The porogen composition of claim 3, wherein the porogen composition comprises a mean porogen diameter of about 300 μ

m to about 650 μ

m.

9. The porogen composition of claim 8, wherein the porogen composition comprises a mean porogen diameter of about 550 μ

m.

10. A porogen composition comprising a core material and a shell material, wherein the core material comprises at least two compounds, wherein under a given physical or physicochemical treatment the shell material is fusible and the core material is non-fusible.

11. The porogen composition of claim 10, wherein the shell fusion occurs by a physical state change from solid phase to liquid or rubbery phase.

12. The porogen composition of claim 10, wherein the shell material comprises at least two compounds.

13. The porogen composition of claim 10, wherein the core material comprises a sugar or a derivative thereof, a polysaccharide or a derivative thereof, a composite thereof, or a combination thereof.

14. The porogen composition of claim 10, wherein the core material comprises sucrose and starch.

15. The porogen composition of claim 10, wherein the shell material comprises polyethylene glycol.

16. The porogen composition of claim 14, wherein the porogen composition comprises about 35% to about 50% sucrose, about 10% to about 15% starch, and about 40% to 50% polyethylene glycol, by weight.

17. The porogen composition of claim 16, wherein the porogen composition comprises about 45% sucrose, about 10% starch, and about 45% polyethylene glycol, by weight.

18. The porogen composition of claim 16, wherein the porogen composition comprises about 40% sucrose, about 15% starch, and about 45% polyethylene glycol, by weight.

19. The porogen composition of claim 14, wherein the porogen composition comprises a mean porogen diameter of about 300 μ

m to about 650 μ

m.

20. The porogen composition of claim 19, wherein the porogen composition comprises a mean porogen diameter of about 550 μ

m.

21. A method for forming a breast implant, the method comprising the steps of:

(a) coating a base material with an uncured elastomer base to form an elastomer coated base shell, wherein the uncured elastomer base comprises a silicon-based elastomer and a solvent;

(b) coating the elastomer coated base shell with porogens to form an elastomer coated porogen mixture, wherein each of the porogens comprises a shell material and a core material, wherein the core material comprises at least two compounds, wherein the shell material has a melting temperature that is lower than a melting temperature of the core material;

(c) repeating step (a);

(d) repeating step (b);

(e) treating the elastomer coated porogen mixture such that the porogens are fused to form a porogen scaffold and the uncured elastomer base is cured; and

(f) removing the porogen scaffold, wherein the removing the porogen scaffold results in the base material with porous material.

22. The method of claim 21, wherein the core material comprises sucrose and starch, and the shell material comprises polyethylene glycol.

23. The method of claim 22, wherein the porogen composition comprises about 35% to about 50% sucrose, about 10% to about 15% starch, and about 40% to 50% polyethylene glycol, by weight.

24. The method of claim 23, wherein the porogen composition comprises about 45% sucrose, about 10% starch, and about 45% polyethylene glycol, by weight.

25. The method of claim 23, wherein the porogen composition comprises about 40% sucrose, about 15% starch, and about 45% polyethylene glycol, by weight.

26. The method of claim 23, wherein the porogen composition comprises a mean porogen diameter of about 300 μ

m to about 650 μ

m.

27. The method of claim 21, wherein steps (a)-(d) are conducted at about 20°

C. to about 30°

C., and step (e) is conducted in the range of about 100°

C. to about 150°

C.

28. The method of claim 21, wherein steps (a)-(d) are conducted at about 20°

C. to about 25°

C., and step (e) is conducted in the range of about 110°

C. to about 135°

C.

29. The method of claim 21, wherein step (e) is conducted at about 126°

C. for about 85 minutes.

30. The method of claim 21, further comprises devolitalizing the solvent following step (a), step (b), step (c), step (d), or any combination thereof.

31. The method of claim 21, wherein the devolitalization step following step (a) about 15 minutes to about 25 minutes.

32. The method of claim 21, wherein the devolitalization step following step (b) and/or Step (d) is about 3 minutes to about 6 minutes.

33. The method of claim 38, wherein the devolitalization step following step (c) about 20 minutes to about 50 minutes.

34. A method for forming a breast implant with porous material, the method comprising the steps of:

(a) coating a breast implant shell with an uncured elastomer base to form an elastomer coated breast implant shell wherein the uncured elastomer base comprises a silicon-based elastomer and a solvent;

(b) devolitalizing the solvent;

(c) coating the elastomer coated breast implant shell with porogens to form an elastomer coated porogen mixture, wherein each of the porogens comprises a shell material comprising sucrose and starch, and a core material comprising polyethylene glycol, wherein the core material comprises at least two compounds, wherein the shell material has a melting temperature that is lower than a melting temperature of the core material;

(d) devolitalizing the solvent;

(e) repeating step (a);

(f) devolitalizing the solvent;

(g) repeating step (c);

(h) devolitalizing the solvent;

(i) repeating step (a);

(j) devolitalizing the solvent;

(k) repeating step (c);

(l) devolitalizing the solvent;

(m) treating the elastomer coated porogen mixture such that the porogens are fused to form a porogen scaffold and the uncured elastomer base is cured; and

(n) removing the porogen scaffold, wherein the removing the porogen scaffold results in the breast implant with porous material.