Films and methods of manufacture

Patent metadata

Field	Value
Publication number	US-10617653-B2
Application number	US-201615177687-A
Country	US
Kind code	B2
Filing date	Jun 9, 2016
Priority date	Dec 28, 2011
Publication date	Apr 14, 2020
Grant date	Apr 14, 2020

Abstract

A flexible body comprises a polymer film having a first surface and an opposing second surface. The polymer film has a plurality of apertures extending from the first surface to the second surface and a plurality of raised lips protruding from the first surface such that each of the plurality of apertures is surrounded by one of the plurality of raised lips. A method of producing a polymer film comprises placing a polymer solution into a one sided mold having a plurality of protrusions extending from a bottom of the mold wherein the polymer solution is characterized by a viscosity that inhibits the unaided flow of the polymer throughout the mold; urging the polymer solution around each of the plurality of protrusions; and solidifying the polymer solution.

First claim

What is claimed:

1. A method of producing an implantable drug eluting polymer film comprising:
preparing a polymer solution including a solvent, a biologically compatible polymer, and a water-soluble antimicrobial or antibiotic drug, wherein the drug is suspended in the polymer solution as discrete drug particles having an average particle diameter of under 20 microns or smaller;
placing the polymer solution containing the discrete drug particles into a one-sided mold having a plurality of protrusions extending from a bottom of the mold wherein the polymer solution is characterized by a viscosity that inhibits the unaided flow of the polymer throughout the mold;
urging the polymer solution around each of the plurality of protrusions; and
solidifying the polymer solution into an implantable polymer film, wherein during solidifying of the polymer solution into the film, the polymer solution forms a raised meniscus around each of the plurality of protrusion and a plurality of raised lips are formed in the film around each of the plurality of protrusion from solidification of the raised meniscus such that the raised lips each surround an aperture in the film formed from each of the plurality of protrusions and wherein the polymer film is configured to release the discrete drug particles in a two-phase release profile including an initial burst release of the portion of the discrete drug particles exposed at a surface at a surface of the polymer film.

2. The method of claim 1 , wherein the mold includes a perimeter form extending to an elevation that is substantially equal to an elevation of each of the plurality of protrusions.

3. The method of claim 2 , wherein the urging comprises drawing a urging means across the perimeter form and the plurality of protrusions to force the polymer solution to flow around the plurality of protrusions and throughout the mold such that the polymer solution has a substantially uniform thickness.

4. The method of claim 3 , wherein an outer surface of each of the protrusions is substantially free of polymer solution after the drawing.

5. The method of claim 2 , wherein the placing step includes depositing the polymer solution in the mold such that a portion of the polymer solution is above the elevation of the perimeter form and the protrusions.

6. The method of claim 1 , wherein the polymer solution is formed by combining a solvent, a polymer, and the drug at a temperature below 90° C.

7. The method of claim 1 , wherein solidifying the polymer solution includes reducing a thickness of the polymer solution.

8. The method of claim 1 , wherein a distance from the bottom of the mold to a top of each of the plurality of protrusions is less than approximately 0.3 mm.

9. The method of claim 1 , wherein the perimeter form defines a total mold area and the plurality of protrusions define an area that is at least about 15% of the total mold area.

10. The method of claim 1 , further comprising peeling the drug eluting film from the mold.

11. The method of claim 1 wherein the polymer solution comprises a cross-linkable pre-polymer solution.

12. The method of claim 1 , wherein the solidifying step includes cross-linking the polymer by applying UV radiation, temperature change, polymerization catalysts, soluble cross-linking agents or combinations thereof to the polymer solution.

13. The method of claim 1 , wherein the polymer solution comprises a first solvent and a polymer and the solidifying step includes exposing the polymer solution to a second solvent in which the first solvent is soluble and in which the polymer and the drug are not soluble such that the first solvent is at least substantially removed from the polymer solution and the polymer solidifies to contain the drug.

14. The method of claim 1 , wherein the discrete drug particles have an average particle diameter in the range of about 10 microns to about 20 microns.

15. The method of claim 1 , wherein the discrete drug particles have an average particle diameter of under 10 microns or smaller.

16. The method of claim 1 , wherein the solidifying step comprises exposing a portion of the discrete drug particles at a surface of the polymer film.

17. The method of claim 1 , wherein the discrete drug particles comprise about 10% to about 13% by weight of the total weight of the polymer film.

18. The method of claim 1 , wherein the polymer solution includes a second drug.

19. The method of claim 18 , wherein the second drug is soluble in the polymer solution.

20. The method of claim 19 , wherein the second drug is an antimicrobial or antibiotic agent.

21. The method of claim 1 , wherein solidifying the polymer solution forms a polymer film defining a first surface and a second surface and a continuous planar portion extending along the first surface between the plurality of raised lips, the continuous planar portion having an average thickness between the first surface and the second surface in the range of approximately 0.05 mm to approximately 0.50 mm, and wherein the plurality of raised lips have a height measured above the continuous planar portion in the range of 0.1 mm to approximately 1.0 mm.

Assignees

• Depuy Synthes Products Inc

Inventors

• Armbruster David
• Dwyer James
• Chomyn Jeffrey
• Kerr Sean

Classifications

• A61L27/54

  Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)} · CPC title

• A61F2250/0067

  Means for introducing or releasing pharmaceutical products into the body · CPC title

• Y10T428/24479

  including variation in thickness · CPC title

• Y10T428/24182

  Inward from edge of web or sheet · CPC title

• A61F2/2846

  Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects (nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006) · CPC title