Resorbable thin membranes

• US 7,592,017 B2
• Filed: 07/31/2003
• Issued: 09/22/2009
• 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:
  US10/631,980
• Publication Number:
  US 20040137033A1
• Time in Patent Office: 2,245 Days
• Field of Search: 514/310
• US Class Current: 424/426
• 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 resorbable adhesion-inhibition membrane for inhibiting adhesions and scarring comprising a substantially uniform composition of a polymeric material, the polymeric material being capable of resorbing into a mammalian body within a period greater than 6 months and less than 24 months from an initial implantation of the adhesion-inhibition membrane into the mammalian body, the polymeric material having a biased molecular orientation in the membrane that is biased to at least one axis, with a viscosity property greater than about 1 g/dL to 3.5 g/dL and an anti-inflammatory characteristic comprising a first substantially-smooth non-porous surface, and the membrane having an opposing second surface and a thickness of about 0.001 mm to about 0.300 mm as measured between the first substantially-smooth non-porous surface and the opposing second surface.

2. The membrane of claim 1, wherein the polymeric material comprises a substantially amorphous polymer.

3. The membrane of claim 1 wherein the molecular orientation of a polymer of the polymeric material is biased toward one axis.

4. The membrane of claim 1 wherein the molecular orientation of a polymer of the polymeric material is biased toward two axes.

5. The membrane of claim 1 being about 0.010 mm to about 0.100 mm thick.

6. The membrane of claim 1 being about 0.015 mm to about 0.025 mm thick.

7. The membrane of claim 1 being about 0.020 mm thick.

8. The membrane of claim 1 wherein the membrane has a glass transition temperature, and a thickness of the membrane increases by at least 5 times when the membrane is brought to its glass transition temperature.

9. The membrane of claim 1 wherein the membrane has a glass transition temperature, and a thickness of the membrane increases by at least 10 times when the membrane is brought to its glass transition temperature.

10. The membrane of claim 1 being impregnated with an additive selected from the group consisting of a chemotactic substance for influencing cell-migration, an inhibitory substance for influencing cell-migration, a mitogenic growth factor for influencing cell proliferation and a growth factor for influencing cell differentiation.

11. The membrane of claim 1 being contained in a sealed sterile packaging.

12. The membrane of claim 1 further having at least one thick portion, each thick portion has a length equal to or shorter than the longest length of the membrane, a width greater than about 0.5 mm, and a thickness greater than about 2 times a thickness of a central area of the membrane.

13. The membrane of claim 12 wherein the thick portion protrudes from both of the two surfaces and forms at least a segment of an edge of the membrane.

14. The membrane of claim 12 wherein a first thick portion forms at least a segment of a first edge of the membrane, and a second thick portion forms at least a segment of a second edge of the membrane.

15. The membrane of claim 12 wherein a thickness of the membrane increases more than 2 times when the membrane is brought to its glass transition temperature.

16. The membrane of claim 14 further comprising a plurality of holes disposed along the thick portion.

17. The membrane of claim 1 further comprising a plurality of holes disposed along an edge of the membrane.

18. The membrane of claim 1 having a viscosity property greater than about 2 g/dL.

19. The membrane of claim 1 having a viscosity property of about 3 g/dL.

20. The membrane of claim 1 having a non-uniform shrinking characteristic.

21. The membrane of claim 1 having a directional shrinking characteristic.

22. A resorbable adhesion-inhibition membrane for inhibiting adhesions and scarring, comprising a substantially uniform composition of a polymeric material extruded into a membrane, the adhesion-inhibition membrane being capable of resorbing into a mammalian body within a period greater than 6 months to 24 months from an initial implantation of the membrane into the mammalian body, the membrane having an anti-inflammatory characteristic with a viscosity property greater than about 2.5 to 3.5 g/dL, the anti-inflammatory characteristic comprising a substantially-smooth anti-inflammatory surface and the membrane being about 0.001 mm to about 0.300 mm thick as measured between the substantially-smooth anti-inflammatory surface and a second opposing surface of the membrane.

23. The membrane of claim 22, wherein the polymeric material comprises a substantially amorphous polymer.

24. The membrane of claim 22 further comprising at least one thick portion, the at least one thick portion having a length equal to or shorter than a longest length of the membrane, a width greater than about 0.5 mm, and a thickness greater than about 2 times the thickness of the membrane at a region other than the at least one thick portion.

25. The membrane of claim 24 wherein the thick portion protrudes from both of the two surfaces and forms at least a segment of an edge of the membrane.

26. The membrane of claim 24 wherein a first thick portion forms at least a segment of a first edge of the membrane, and a second thick portion forms at least a segment of a second edge of the membrane.

27. The membrane of claim 24 wherein the thick portion is effective to provide rigidity to the membrane.

28. The membrane of claim 24 further comprising a plurality of holes disposed along the thick portion.

29. A resorbable anti-adhesive membrane comprising a substantially uniform composition of a polymeric material, the polymeric material being capable of resorbing into a mammalian body within a period greater than 6 months to 24 months from an initial implantation of the anti-adhesive membrane into the mammalian body, the polymeric material comprising a polylactide and having a biased molecular orientation in the membrane that is biased to at least one axis and a viscosity property of about 1 g/dL to 3.5 g/dL, the membrane having at least one substantially-smooth-anti-adhesive surface and being non-porous, the membrane also having a thickness of about 0.00 1 mm to about 0.300 mm as measured between the substantially-smooth anti-adhesive surface and an opposing surface of the membrane, wherein the membrane has a glass transition temperature and a thickness of the membrane increases by at least 5 times when the membrane is brought to its glass transition temperature.

30. A resorbable anti-adhesive membrane comprising a substantially uniform composition of a polymeric material capable of resorbing into a mammalian body within a period greater than 6 months to 24 months from an initial implantation of the anti-adhesive membrane into the mammalian body, the polymeric material comprising a polylactide and having a biased molecular orientation in the membrane that is biased to at least one axis and a viscosity property that is of about 1.25 g/dL to 1.75 g/dL, the membrane having at least one substantially-smooth anti-adhesive surface and being non-porous, the membrane further having a thickness of about 0.00 1 mm to about 0.300 mm as measured between the substantially-smooth anti-adhesive surface and an opposing surface of the membrane, wherein the membrane has a glass transition temperature and a thickness of the membrane increases by at least 10 times when the membrane is brought to its glass transition temperature.