Resorbable thin membranes

• US 8,012,502 B2
• Filed: 11/09/2007
• Issued: 09/06/2011
• Est. Priority Date: 03/10/2000
• Status: Expired due to Fees

• Current Assignee: MAST Biosurgery AG
• Original Assignee: MAST Biosurgery AG
• Inventors: Kleinhenz, Kenneth K., Holmes, Ralph E., Calhoun, Christopher J.
• Primary Examiner(s): Padmanabhan; Sreeni
• Assistant Examiner(s): BETTON, TIMOTHY E
• Application Number:
  US11/983,562
• Publication Number:
  US 20080063686A1
• Time in Patent Office: 1,397 Days
• Field of Search: 424/426
• US Class Current: 424/435
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61K 31/765 Polymers containing oxygen
• 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 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

Resorbable lactide polymer thin membranes are disclosed. The thin membranes are constructed of polylactide resorbable polymers, which are engineered to be absorbed into the body relatively slowly over time in order to reduce potential negative side effects. The membranes are formed to have very thin thicknesses, for example, thicknesses between about 0.010 mm and about 0.300 mm. The membranes can be extruded from polylactide polymers having a relatively high viscosity property, can be preshaped with relatively thick portions, and can be stored in sterile packages.

Claims

1. A system, comprising:

a resorbable scar-tissue reduction micro-membrane for attenuating a formation of post-surgical scar tissue between a healing post-surgical site and adjacent surrounding tissue following an in vivo surgical procedure on the post-surgical site, the resorbable scar-tissue reduction micro-membrane having a pre-implant configuration that is defined as a configuration of the implant immediately before the implant is formed between the post-surgical site and the adjacent surrounding tissue, the resorbable scar-tissue reduction micro-membrane having a first substantially-smooth, drug-free, planar, non-porous side and a second substantially-smooth, drug-free, planar, non-porous side, the resorbable scar-tissue reduction micro-membrane resorbing from more than 6 months to 24 months, having a viscosity property from more than about 1 g/dL to 3.5 g/dL, and a single layer of resorbable polymer base material between the first substantially-smooth side and the second substantially-smooth side, the layer of resorbable polymer base material having a substantially uniform drug-free composition and comprising a polymer selected from the group consisting essentially of a lactide polymer, ethylene oxide and a copolymer of cyclic esters, a thickness of the layer of resorbable polymer base material, measured between the first substantially-smooth side and the second substantially-smooth side, being about 0.001 mm to 0.300 mm; and

another resorbable membrane comprising opposing sides defining therebetween a single layer, which has a substantially uniform drug-free composition the same as that of the resorbable polymer base material, which comprises a thickness greater than the thickness of the layer of resorbable polymer base material and less than 2000 microns, and which comprises pores whereby the other resorbable membrane is permeable.

2. The system as set forth in claim 1, the resorbable polymer base material being a copolymer comprising one or more of an oligomer of ethylene oxide, a polymer of ethylene oxide and polylactide.

3. The system as set forth in claim 1, wherein the resorbable polymer base material is a copolymer comprising lactide and epsilon caprolactone.

4. The system as set forth in claim 1, wherein the resorbable scar-tissue reduction micro-membrane is sterilized using ethylene oxide or comprises ethylene oxide.

5. The system as set forth in claim 1, wherein the thickness of the layer of resorbable polymer base material is 200 microns or less.

6. The system as set forth in claim 1, wherein the layer of resorbable polymer base material is substantially planar and comprises one or more of a polymerized ethylene oxide and a polylactide.

7. The system as set forth in claim 1, wherein the resorbable scar-tissue reduction micro-membrane is impregnated with at least one of a chemotactic substance for influencing cell-migration, an inhibitory substance for influencing cell-migration, a mitogenic growth factor for influencing cell proliferation, a growth factor for influencing cell differentiation.

8. The system as set forth in claim 1, wherein the resorbable scar-tissue reduction micro-membrane consists essentially of a single layer of resorbable polymer base material between the first substantially-smooth side and the second substantially-smooth side.

9. The system as set forth claim 1, wherein the resorbable scar-tissue reduction micro-membrane comprises a plurality of holes disposed along an edge of the resorbable scar-tissue reduction micro-membrane.

10. The system as set forth in claim 1, wherein:

the resorbable scar-tissue reduction micro-membrane comprises a plurality of holes disposed along an edge of the resorbable scar-tissue reduction micro-membrane; and

the edge extends around the resorbable scar-tissue reduction micro-membrane.

11. The system as set forth in claim 1, wherein:

the resorbable scar-tissue reduction micro-membrane comprises a plurality of holes disposed along an edge of the resorbable scar-tissue reduction micro-membrane; and

the resorbable scar-tissue reduction micro-membrane does not comprise any holes substantially away from the edge of the resorbable scar-tissue reduction micro-membrane.

12. The system as set forth in claim 1, wherein at least one slit is formed in a periphery of the resorbable scar-tissue reduction micro-membrane so that the edge extends along the slit.

13. The system as set forth in claim 1, wherein:

the resorbable scar-tissue reduction micro-membrane further comprises a plurality of holes disposed away from the edge;

each of the holes near the periphery has a first diameter;

each of the holes near the center has a second diameter; and

the first diameters are greater than the second diameters.

14. The system as set forth in claim 1, wherein:

the system further comprises a plurality of holes disposed along an edge of the resorbable scar-tissue reduction micro-membrane; and

a plurality of slits are formed in a periphery of the resorbable scar-tissue reduction micro-membrane so that the edge extends along the slit.

15. The system as set forth in claim 1, wherein:

the resorbable scar-tissue reduction micro-membrane further comprises a plurality of holes disposed along the edge; and

the resorbable scar-tissue reduction micro-membrane comprises at least one slit disposed in the layer of resorbable polymer base material.

16. The system as set forth in claim 1, wherein:

the system further comprises a plurality of holes disposed along an edge of the resorbable scar-tissue reduction micro-membrane; and

the resorbable scar-tissue reduction micro-membrane is sealed in a sterile packaging.

17. The system as set forth in claim 1, wherein:

the resorbable scar-tissue reduction micro-membrane is cut to have at least one tab; and

the resorbable scar-tissue reduction micro-membrane is sealed in a sterile packaging.

18. The system as set forth in claim 1, wherein:

the resorbable scar-tissue reduction micro-membrane comprises at least one notch disposed in the layer of resorbable polymer base material; and

the resorbable scar-tissue reduction micro-membrane is sealed in a sterile packaging.

19. The system as set forth in claim 1, wherein:

the resorbable scar-tissue reduction micro-membrane comprises a plurality of notches disposed in the layer of resorbable polymer base material; and

the resorbable scar-tissue reduction micro-membrane is sealed in a sterile packaging.

20. The system as set forth in any one of claims 1 to 19, wherein:

the resorbable scar-tissue reduction micro-membrane is cut to have a non-rectangular and non-circular shape; and

the resorbable scar-tissue reduction micro-membrane is sealed in a sterile packaging.

21. The system as set forth in any one of claims 1 and 4 to 19, wherein:

the layer of resorbable polymer base material consists essentially of one or more of;

a poly-lactide; and

a copolymer of two or more lactides.

22. The system as set forth in any one of claims 1 to 16, 18 and 19, wherein:

the resorbable scar-tissue reduction micro-membrane is cut with tabs to be folded over or around an anatomic structure; and

the resorbable scar-tissue reduction micro-membrane is sealed in a sterile packaging.

23. The system as set forth in any one of claims 1 to 19, wherein the thickness of the layer of resorbable polymer base material is 100 microns.

24. The system as set forth in any one of claims 1 to 19, wherein the layer of resorbable polymer base material is not fluid permeable.

25. The system as set forth in any one of claims 1 to 19, wherein the layer of resorbable polymer base material is fluid permeable.

26. The system as set forth in any one of claims 1 to 19, wherein the layer of resorbable polymer base material is cell permeable.

27. The system as set forth in any one of claims 1 to 19, wherein the resorbable scar-tissue reduction micro-membrane is vessel permeable.

28. The system as set forth in any one of claims 1 to 19, wherein the other membrane is fluid permeable.

29. The system as set forth in any one of claims 1 to 19, wherein the other membrane is cell permeable.

30. The system as set forth in any one of claims 1 to 19, wherein the other membrane is vessel permeable.

31. The system as set forth in any one of claims 1 to 19, wherein:

the layer of resorbable polymer base material consists essentially of a material selected from the group consisting of;

a lactide polymer; and

a copolymer of two or cyclic esters.

32. The system as set forth in any one of claims 1 to 19 wherein the layer of resorbable polymer base material is adapted to maintain a smooth-surfaced barrier between the healing post-surgical site and the adjacent surrounding tissue for a period of time sufficient to attenuate or eliminate formation of scar tissue between the post-surgical site and the adjacent surrounding tissue.

33. The system as set forth in any one of claims 1 to 19, wherein the layer of resorbable polymer base material is adapted to be resorbed into the mammalian body on or before a period of approximately 18 to 24 months from an initial implantation of the implant into the mammalian body.

34. The system as set forth in any one of claims 1 to 19, wherein the other membrane comprises a thickness between 500 microns and 2000 microns.