Films and methods of manufacture

• US 9,381,683 B2
• Filed: 12/27/2012
• Issued: 07/05/2016
• Est. Priority Date: 12/28/2011
• Status: Active Grant

• Current Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Original Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Inventors: Armbruster, David, Dwyer, James, Chomyn, Jeffrey, Kerr, Sean
• Primary Examiner(s): Vonch, Jeff
• Application Number:
  US13/727,682
• Publication Number:
  US 20130171410A1
• Time in Patent Office: 1,286 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• 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 17/8028 Cushions, i.e. elements forming interface between bone plate and bone
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/561 Implants with special means for releasing a drug
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/2846 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 Class Codes: A61F 2/30907 Nets or sleeves applied to surface of prostheses or in cement
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30064 Coating or prosthesis-covering structure made of biodegradable material
• CPC Class Codes: A61F 2002/30067 Coating or prosthesis-covering structure made of thermoplastic material
• CPC Class Codes: A61F 2002/30069 elastomeric
• CPC Class Codes: A61F 2002/30919 Sleeves
• CPC Class Codes: A61F 2013/00221 biodegradable, non-irritating
• CPC Class Codes: A61F 2013/00357 implanted wound fillings or covers
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0031 : made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0067 : Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61K 31/085 : having an ether linkage to aromatic ring nuclear carbon
• CPC Class Codes: A61K 31/7036 : having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
• CPC Class Codes: A61K 9/0024 : Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• 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 2300/604 : Biodegradation
• CPC Class Codes: A61L 27/18 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/50 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61M 31/002 : Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: B29C 39/003 : characterised by the choice of material
• CPC Class Codes: B29C 39/026 : characterised by the shape of the surface
• CPC Class Codes: B29C 39/24 : Feeding the material into the mould
• CPC Class Codes: B29C 39/26 : Moulds or cores
• CPC Class Codes: B29C 39/38 : Heating or cooling
• CPC Class Codes: B29C 41/02 : for making articles of definite length, i.e. discrete articles
• CPC Class Codes: B29D 7/01 : Films or sheets
• CPC Class Codes: B29K 2067/04 : Polyesters derived from hydroxycarboxylic acids
• CPC Class Codes: B29K 2067/043 : PGA, i.e. polyglycolic acid or polyglycolide
• CPC Class Codes: B29K 2067/046 : PLA, i.e. polylactic acid or polylactide
• CPC Class Codes: B29K 2105/0002 : monomers or prepolymers
• CPC Class Codes: B29K 2105/0035 : Medical or pharmaceutical agents
• CPC Class Codes: B29K 2105/0073 : Solution
• CPC Class Codes: B29K 2995/006 : Bio-degradable, e.g. bioabsorbable, bioresorbable or bioerodible
• CPC Class Codes: B29L 2007/008 : Wide strips, e.g. films, webs
• CPC Class Codes: B29L 2031/753 : Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: C08J 2367/04 : Polyesters derived from hydroxy carboxylic acids, e.g. lactones C08J2367/06 takes precedence
• CPC Class Codes: C08J 2369/00 : Characterised by the use of polycarbonates; Derivatives of polycarbonates
• CPC Class Codes: C08J 5/18 : Manufacture of films or sheets
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: C08L 69/005 : Polyester-carbonates
• CPC Class Codes: Y10S 525/937 : Utility as body contact e.g. implant, contact lens or I.U.D.
• CPC Class Codes: Y10T 428/24182 : Inward from edge of web or sheet
• CPC Class Codes: Y10T 428/24281 : Struck out portion type
• CPC Class Codes: Y10T 428/24479 : including variation in thickness
• CPC Class Codes: Y10T 428/25 : Web or sheet containing structurally defined element or component and including a second component containing structurally defined particles
• CPC Class Codes: Y10T 428/26 : Web or sheet containing structurally defined element or component, the element or component having a specified physical dimension

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.

Claims

1. An implantable medical device comprising:

a flexible polymer film having a first surface and an opposing second surface, the polymer 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, wherein each one of the plurality of lips is continuous with and surrounds one of the plurality of apertures;

wherein the film includes a plurality of discrete eluting drug components disposed within the film, the plurality of discrete eluting drug components have an average diameter under 10 microns and comprising at least an antibiotic active against orthopedic implant related infections;

wherein the polymer film elutes the antibiotic from the discrete eluting drug components in a two phase release process including a burst release process upon exposure to water or a body fluid, and a controlled release process, wherein the burst release process releases about 20% to 35% of the total content of the antibiotic, and the two phase release process releases the total content of the antibiotic within a three-week period.

2. The implantable medical device of claim 1, wherein the polymer film comprises a bioresorbable polymer.

3. The implantable medical device of claim 2, wherein the bioresorbable polymer contains repeat units selected from the group consisting of:

L-lactic acid, D-lactic acid, L-lactide, D-lactide, D,L-lactide, glycolide, a lactone, a lactam, trimethylene carbonate, a cyclic carbonate, a cyclic ether, para-dioxanone, beta-hydroxybutyric acid, beta-hydroxypropionic acid, beta-hydroxyvaleric acid, and a combination thereof.

4. The implantable medical device of claim 2, wherein the bioresorbable polymer contains repeat units selected from the group consisting of:

L-lactic acid, D-lactic acid, L-lactide, D-lactide, D,L-lactide, ε

-caprolactone, trimethylene carbonate, para-dioxanone, and a combination thereof.

5. The implantable medical device of claim 2, wherein the bioresorbable polymer is a copolymer of glycolide, trimethylene carbonate, lactide and caprolactone.

6. The implantable medical device of claim 1, wherein the first surface includes a contiguous planar portion extending between the plurality of raised lips.

7. The implantable medical device of claim 6, wherein the plurality of raised lips each has an outer edge that is raised above the contiguous planar portion by approximately 0.1 mm to approximately 1.0 mm.

8. The implantable medical device of claim 1, wherein the film further comprising at least one seam configured to form the polymer film into a sheath.

9. The implantable medical device according to claim 8, wherein the sheath is shaped to match a bone plate.

10. The implantable medical device of claim 1, wherein the polymer film has a first tensile strength in a first planar direction and a second tensile strength in a second planar direction that is perpendicular to the first planar direction, wherein the first tensile strength is substantially equal to the second tensile strength.

11. The implantable medical device of claim 1, wherein the polymer film has a nominal thickness of no greater than 0.06 mm.

12. The implantable medical device of claim 1, wherein the first surface has a first tactile feel that is different from a second tactile feel of the second surface.

13. The implantable medical device according to claim 1, wherein the antibiotic is gentamicin sulfate.

14. The implantable medical device according to claim 1, wherein the film has a porosity from about 0.1 to about 0.2.

15. The implantable medical device according to claim 1, wherein the film has a porosity from about 0.1 to about 0.15.

16. The implantable medical device according to claim 1, wherein the film has a porosity from about 0.15 to about 0.2.

17. The implantable medical device according to claim 1, wherein the apertures are evenly spaced across the film.

18. The implantable medical device according to claim 1, wherein a portion of the film includes the apertures spaced apart in at least two spacing configurations.

19. The implantable medical device according to claim 1, wherein the apertures have an average diameter of approximately 0.75 mm.

20. The implantable medical device according to claim 1, wherein the apertures have an average diameter of approximately 1.5 mm.

21. The implantable medical device according to claim 1, wherein the film has an average spacing between adjacent apertures of approximately 1.75 mm.