Medical film

• US 7,718,556 B2
• Filed: 12/08/2003
• Issued: 05/18/2010
• Est. Priority Date: 12/16/2002
• Status: Active Grant

• Current Assignee: Gunze Limited
• Original Assignee: Gunze Limited, JMS Company Limited
• Inventors: Matsuda, Shojiro, Ohtani, Hitoshi, Tanaka, Yoshimi, Tadokoro, Hideki
• Primary Examiner(s): Chriss; Jennifer A
• Application Number:
  US10/536,590
• Publication Number:
  US 20060094318A1
• Time in Patent Office: 2,353 Days
• Field of Search: 606/228, 606/230, 606/231, 442/123, 442/181, 442/304, 442/327, 424/426, 424/444
• US Class Current: 442/123
• CPC Class Codes: A61L 31/045 Gelatin
• CPC Class Codes: A61L 31/129 containing macromolecular fillers
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: Y10T 442/2484 Coating or impregnation is water absorbency-increasing or hydrophilicity-increasing or hydrophilicity-imparting
• CPC Class Codes: Y10T 442/2525 Coating or impregnation functions biologically [e.g., insect repellent, antiseptic, insecticide, bactericide, etc.]
• CPC Class Codes: Y10T 442/2861 Coated or impregnated synthetic organic fiber fabric
• CPC Class Codes: Y10T 442/3854 Woven fabric with a preformed polymeric film or sheet
• CPC Class Codes: Y10T 442/45 Knit fabric is characterized by a particular or differential knit pattern other than open knit fabric or a fabric in which the strand denier is specified
• CPC Class Codes: Y10T 442/674 Nonwoven fabric with a preformed polymeric film or sheet

Abstract

A medical film that is excellent in biocompatibility and bioabsorbability and has an excellent strength in suturing and bonding is provided. A reinforcing material 12 made of a biodegradable polymer is placed in a gelatin solution so as to allow the solution to infiltrate in the reinforcing material 12 and then the gelatin is dried. This allows the gelatin that has infiltrated entirely in an internal part of the reinforcing material 12 to gel, thereby forming a gelatin film 11. Thus, a medical film 1 in which the reinforcing material 12 and the gelatin film 11 are integrated is obtained. The gelatin film 11 preferably is a cross-linked gelatin film.

Claims

1. A medical film, comprising:

a gelatin film, and

a reinforcing material made of a biodegradable polymer,

wherein the reinforcing material is a warp knitted fabric,

the warp knitted fabric is in a form of a mesh with diamond-shaped pores or a mesh with hexagon pores,

a unit of stitches of the warp knitted fabric has a vertical length of 0.5 to 8 mm and a horizontal length of 0.5 to 8 mm,

a yarn of the warp knitted fabric includes a multifilament yarn and a thickness of the yarn is in a range of 30 denier to 200 denier (33.3 decitex to 222.2 decitex),

the reinforcing material is disposed on at least one film surface of the gelatin film so as to extend over an entire area in a plane direction,

the reinforcing material is embedded entirely in the gelatin film,

the reinforcing material and the gelatin film are integrated due to gelling of gelatin that has infiltrated entirely in an internal part of the reinforcing material, and

the medical film serves as an antiadhesive material.

2. The medical film according to claim 1, wherein the medical film is in a sheet form or in a cylindrical form.

3. The medical film according to claim 1, wherein the reinforcing material is processed by hot pressing.

4. The medical film according to claim 1, wherein the reinforcing material has a density in a range of 3 g/m² to 200 g/m².

5. The medical film according to claim 1, wherein the reinforcing material has a thickness in a range of 10 μ

m to 1000 μ

m.

6. The medical film according to claim 1, wherein the reinforcing material has a yarn threading tension in a range of 0.3 N to 200 N.

7. The medical film according to claim 1, wherein the biodegradable polymer is at least one polymer selected from the group consisting of polylactic acid, lactic acid-caprolactone copolymer, and polyglycolic acid.

8. The medical film according to claim 7, wherein a molar ratio (A:

B) of lactide (A) and caprolactone (B) in the lactic acid-caprolactone copolymer is in a range of 85;

15 to 40;

60.

9. The medical film according to claim 1, wherein the reinforcing material is subjected to a hydrophilicity imparting treatment.

10. The medical film according to claim 9, wherein the hydrophilicity imparting treatment is at least one treatment selected from the group consisting of plasma treatment, glow discharge treatment, corona discharge treatment, ozone treatment, graft treatment, coating, chemical treatment, and ultraviolet irradiation.

11. The medical film according to claim 1, wherein the gelatin film is a cross-linked gelatin film.

12. The medical film according to claim 11, wherein the gelatin film is cross-linked by at least one method selected from the group consisting of ultraviolet treatment, heat treatment, and chemical cross-linking agent treatment.

13. The medical film according to claim 12, wherein the gelatin film is subjected to the ultraviolet treatment and the heat treatment.

14. The medical film according to claim 12, wherein the gelatin film is cross-linked by the ultraviolet treatment under conditions of a power of an ultraviolet lamp of 4 W to 40 W, an irradiation time of 0.1 hour to 100 hours, and an irradiation distance of 5 cm to 100 cm.

15. The medical film according to claim 12, wherein the gelatin film is cross-linked by the ultraviolet treatment under conditions of an ultraviolet intensity of 0.05 mW/cm² to 50 mW/cm² and an ultraviolet dose of 1 J/cm² to 100 J/cm².

16. The medical film according to claim 12, wherein the gelatin film is cross-linked by the heat treatment carried out under vacuum at a temperature of 60°

C. to 180°

C. for 5 minutes to 72 hours.

17. The medical film according to claim 1, wherein a time of presence of the gelatin film in a living body is in a range of 12 hours to 90 days.

18. The medical film according to claim 1, wherein the gelatin film has a thickness in a range of 20 μ

m to 2000 μ

m.

19. The medical film according to claim 1, wherein a concentration of endotoxin contained in the gelatin is not more than 200 EU/g.

20. The medical film according to claim 1, wherein the warp knitted fabric includes yarns formed of a series of intertwining loops.

21. The medical film according to claim 1, wherein yarns of the warp knitted fabric are tangled with one another at yarn-intersecting portions of a knit stitch structure.

22. The medical film according to claim 1, wherein neither rupture nor exposure of the reinforcing material occurs when the tension is less than 1 N.