Resorbable thin membranes

• US 20070116739A1
• Filed: 01/16/2007
• Published: 05/24/2007
• Est. Priority Date: 03/10/2000
• Status: Active Grant

• Current Assignee: MAST Biosurgery AG
• Original Assignee: Macropore Biosurgery, Inc.
• Inventors: Holmes, Ralph, Calhoun, Christopher, Kleinhenz, Kenneth
• Granted Patent: US 7,947,300 B2
• Time in Patent Office: Days
• 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 thin membrane, comprising:

a first substantially-smooth surface and a second substantially-smooth surface, wherein a thickness between the first and the second substantially-smooth surface is about 0.01 mm to about 0.300 mm; and

at least one thick portion, the at least one thick portion having a length less than or equal to 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.

2. The membrane of claim 1, wherein the thick portion protrudes from both of the two substantially-smooth surfaces and forms at least a segment of an edge of the membrane.

3. The membrane of claim 1, comprising a first thick portion forming at least a segment of a first edge of the membrane, and a second thick portion forming at least a segment of a second edge of the membrane.

4. The membrane of claim 1, further comprising a plurality of holes disposed along the thick portion.

5. The membrane of claim 1, wherein the at least one thick portion comprises a plurality of thick portions and the membrane is constructed from a substantially amorphous polymer.

6. The membrane of claim 5, wherein the polymer comprises a polylactide.

7. The membrane of claim 6, wherein the polymer comprises a copolymer of a L-lactide and D,L-lactide.

8. The membrane of claim 5, wherein the polymer comprises a caprolactone.

9. The membrane of claim 5, wherein the polymer has a biased molecular orientation toward one axis.

10. The membrane of claim 5, wherein the polymer has a biased molecular orientation toward two axes.

11. The membrane of claim 5, being about 0.015 mm to about 0.025 mm thick.

12. The membrane of claim 5, 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.

13. The membrane of claim 5, 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.

14. The membrane of claim 5, wherein the membrane is impermeable to a fluid.

15. The membrane of claim 5, further comprising an additive impregnated in the membrane, the additive being 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.

16. The membrane of claim 5, being contained in a sealed sterile packaging.

17. The membrane of claim 5, having a viscosity property greater than about 1 g/dL.

18. The membrane of claim 5, having a viscosity property greater than about 2 g/dL.

19. 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 implant having a pre-implant configuration, which 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 implant comprising:

a substantially planar membrane of resorbable polymer base material having a first substantially-smooth side and a second substantially-smooth side, the substantially planar membrane of resorbable polymer base material comprising a single layer of resorbable polymer base material between the first substantially-smooth side and the second substantially-smooth side, the single layer of resorbable polymer base material having a substantially uniform composition;

wherein a thickness of the single layer of resorbable polymer base material, measured between the first substantially-smooth side and the second substantially-smooth side, is between about 10 microns and about 300 microns;

wherein the single layer of resorbable polymer base material is non-porous; and

wherein the single 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 more cyclic esters; and

wherein the single 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 relatively extended period of time sufficient to attenuate or eliminate any formation of scar tissue between the post-surgical site and the adjacent surrounding tissue, and is adapted to be resorbed into the mammalian body within a period of approximately 24 months or less from an initial implantation of the implant into the mammalian body.

20. The resorbable scar-tissue reduction micro-membrane as set forth in claim 19, wherein the copolymer of two or more cyclic esters comprises lactide and epsilon caprolactone.