Films and methods of manufacture

• US 10,500,304 B2
• Filed: 10/05/2017
• Issued: 12/10/2019
• Est. Priority Date: 06/21/2013
• Status: Active Grant

• Current Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Original Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Inventors: Armbruster, David A., Dwyer, James, Chomyn, Jeffrey, Kerr, Sean H.
• Primary Examiner(s): Coniglio, Audrea B
• Application Number:
  US15/725,586
• Publication Number:
  US 20180028714A1
• Time in Patent Office: 796 Days
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 17/8057 the interlocking form comprising a thread
• CPC Class Codes: A61B 17/8085 with pliable or malleable elements or having a mesh-like structure, e.g. small strips A61B17/8071, A61B17/8076 take precedence
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61F 2/30907 Nets or sleeves applied to surface of prostheses or in cement
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2310/00389 The prosthesis being coated or covered with a particular material
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61K 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• CPC Class Codes: A61L 24/0015 Medicaments; Biocides
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• 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 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: B32B 2535/00 Medical equipment, e.g. bandage, prostheses or catheter
• CPC Class Codes: B32B 3/266 characterised by an apertured layer, the apertures going through the whole thickness of the layer, e.g. expanded metal, perforated layer, slit layer regular cells B32B3/12
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

Embodiments of the present disclosure are directed to perforated polymer films and methods of making the same. In some embodiments, the films are for use with implantable medical devices. In one embodiment there is a flexible body including a polymer film having a first surface and an opposing second surface, the film having 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 a one of the plurality of raised lips. In one embodiment, the film comprises a single layer, and in another embodiment, the film can comprise a plurality of layers. In certain embodiments, the film can comprise an adhesive layer. In another embodiment, one or more of the layers may be a drug containing layer and/or a rate controlling layer for drug release.

Claims

1. A method of forming a biocompatible and implantable multi-layer film for drug delivery comprising:

placing a first polymer solution comprising a biodegradable polymer into a mold having a plurality of protrusions extending from a bottom of the mold;

urging the first polymer solution around each of the plurality of protrusions such that a meniscus of polymer solution is formed around the plurality of protrusions;

placing one or more additional polymer solutions into the mold, the one or more additional polymer solutions comprising a biodegradable polymer, wherein at least one of the first polymer solution or the one or more additional polymer solutions further comprises a drug; and

,

solidifying the first polymer solution and the one or more additional polymer solutions so as to form a biocompatible and biodegradable multi-layer film configured for implantation, wherein the drug is incorporated within film;

wherein the step of solidifying comprises solidifying the meniscus of polymer solution so as form a plurality of raised lips around the plurality of protrusions;

wherein a plurality of apertures is formed in the multi-layer film from the protrusions, the plurality of apertures extending completely through the multi-layer film from a first surface to a second surface and wherein each of plurality of the raised lips surrounds a respective aperture of the plurality of apertures.

2. The method of claim 1, wherein the step of placing one or more additional polymer solutions into the mold occurs prior to the step of urging, such that urging the polymer solution includes urging the first polymer solution and the one or more polymer solutions.

3. The method of claim 1, wherein the step of solidifying the polymer solution occurs both prior to and after the step of placing one or more additional polymer solutions into the mold.

4. The method of claim 1, wherein at least one of the first polymer solution or the one or more additional polymer solutions comprises an adhesive layer when solidified.

5. The method of claim 1, wherein at least one of the first polymer solution, or the one or more additional polymer solutions comprises a rate controlling layer for drug release when solidified.

6. The method of claim 1, wherein the drug is dissolved within the multi-layer film.

7. The method of claim 1, wherein the drug is disposed as discrete units within the multi-layer film.

8. The method of claim 7, wherein the drug particles have an average particle diameter under 20 microns.

9. The method of claim 7, wherein the drug particles have an average particle diameter under 10 microns.

10. The method of claim 1, wherein the drug is contained within the first polymer solution.

11. The method of claim 10, wherein the one or more additional polymer solutions form an adhesive layer or a drug controlling layer of the multi-layer film.

12. The method of claim 1, wherein at least one of the first polymer solution or the one or more additional polymer solutions comprises a plurality of drugs.

13. The method of claim 12, wherein the first polymer solution includes a dissolved drug and insoluble drug particles.

14. The method of claim 1, wherein the drug concentration is between about 0.1% to about 13% by weight of the multi-layer film after solidifying.

15. The method of claim 1, wherein

the plurality of apertures provide porosity to the multi-layer film in the range of about 5% to about 25% of the total surface area of the multi-layer film;

and,

wherein the drug comprises an antimicrobial agent.