MULTIFUNCTIONAL HERNIA PATCH

Abstract

A surgical implant with anti-adhesive, antibacterial and hemostatic properties to use in hernia repair. The implant includes: a) Bilayer intraperitoneal mesh, having biocompatible, antibacterial, hemostatic and anti-adhesive properties including combination of biocompatible non-degradable or semi-degradable mesh. The mesh is prepared with blend system of biodegradable polyester-based polymers/chitosan mixture in hexafluoro isopropanol (HFIP) solvent and coated on polypropylene (PP) layer as nanofibers via electrospun technique; and, b) Double and/or triple-layer extraperitonal composite mesh, was prepared with blend systems of biodegradable polyester-based polymers and/or polysaccharides formed on PP/polyester woven material via different coating methods.

Claims

1. Bilayer intraperitoneal mesh, having biocompatible, antibacterial, hemostatic and anti-adhesive properties and certain thickness and porosity was prepared with combination of PP Mesh and blend system of biodegradable polyester-based polymers and polysaccharides coated on PP layer as nanofiber via electrospun technique: a) Polyester/polysaccharide nanofiber structure and, b) Scaffold system derived from mono or multiflament polypropylene yarn.

2. Double and/or triple-layer extraperitonal composite mesh, which has biocompatible, antibacterial, hemostatic, and antiadhesive properties and certain thickness and porosity, was prepared with blend systems of biodegradable polyester-based polymers and polysaccharides coated on PP/polyester woven material: a) Biodegradable mono or multi-filament polyester/polypropylene yarn and; b) Scaffold coated with polysaccharides.

3. According to claims 1 and 2, wherein polyester is polyglycolic acid, polylactic acid, polyglycolic-co-lactic acid, polytrimethylenecarbonate, polyglycolic-co-trimethylene carbonate, polylactic-co-trimethylene carbonate, polycaprolactone, polyglycolic-co-caprolactone, polylactic-co-caprolactone, politrimetilencarbonate-co-caprolactone.

4. According to claims 1 and 2, wherein polysaccharide is chitosan, chitin, starch, alginate, hyaluronate, and glycogen.

5. According to claims 1 and 2, wherein polyester/polysaccharide part is between 1-99% by weight and polyester part of the blend system has thickness of 1 to 999 micron while total thickness of mesh is from 1 to 1000 microns.

6. According to claims 1 and 2, wherein multi or mono polypropylene yarn diameter is from 1 to 500 microns and the number of multi filament polypropylene yarns is from 2 to 100.

7. According to claim 1, wherein nanofiber diameter of polyester/polysaccharides layer coated on PP mesh is from 10 to 1000 nm.

8. According to claim 2, wherein coating methods for PP/polyester woven material are elektrospun, spray, dip coating and cast method.

9. According to claim 2, wherein polyester filament number for PP/polyester woven material is from 1 to 100.

10. According to claim 8, wherein the device voltage is from 1 to 40 kV, the distance between the needle tip and collector is from 2 to 40 cm, flow rate is from 2 to 5000 microliters/minute.

11. According to claim 8, wherein porosity of polyester/polysaccharide layer is between 10-80% and pore size of polyester/polysaccharide layer is from 10 nm to 10 microns.

12. According to claim 8, wherein solvent used for biodegradable polyester/polysaccharide blend system is a mixture of volatile, polar and non-polar organic solvent and acetic acid or organic solvent and trifluoroacetic acid (TFA).

13. Organic solvents used in this study are indicated in the following list but these solvents are not limited to this list. According to claims 11 and 8, wherein organic solvent is hexafluoro isopropanol (HFIP), dichloromethane, chloroform, dimethylformamide (DMF), tetrahydrofuran (THF), dioxane, dimethylsulfoxide (DMSO), acetone, acetonitrile, 1-butanol, 2-butanol, 2-butanone, t-butyl alcohol, carbon tetrachloride, chlorobenzene, cyclohexane, 1,2-dichloro ethane, diethylene glycol diethyl ether, diethylene glycol diethyl ether, 1,2-dimethoxyethane, ethanol, ethylacetate, ethylene glycol, glycerine, heptane, hexamethylene phosphoramide, hexane, methanol, methyl t-butylether, methylene chloride, N-methyl-2-pyrrolidinone, nitromethane, pentane, petroleum ether, 1-propanol, 2-propanol, pyridine, toluene, triethylamine, water, o-xylene, m-xylene, p-xylene.

14. According to claim 11, wherein volume of acetic acid or TFA in organic solvent/acetic acid, or organic solvent/trifluoroacetic acid mixture is between 1-90%.

15. According to claim 13, wherein solvent used that can be at least one or a mixture of more than one in polyester, polysaccharide or polyester/polysaccharide solution.

16. According to claim 8, wherein polyester/polysaccharide solvent used, weight ratio of polysaccharide to polyester, is between 0.1 to 99.1% and the molecular weight of polyester (M.sub.n) is from 10.000 to 1,000,000 Da.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0026] FIG. 1. Microscope image of PP mesh obtained from the monofilament yarn

[0027] FIG. 2. Microscope image of composites meshes acquired by weave of multi-filaments polyester, polypropylene based yarns

[0028] FIG. 3. Cross section SEM images of monofilament PP mesh

[0029] FIG. 4. Cross section SEM images of monofilament PP mesh coated with polysaccharides by electrospun method

[0030] FIG. 5. Surface SEM images of PP mesh coated with polysaccharides by electrospun method

[0031] FIG. 6. Surface SEM images of PP Mesh coated with PLGA/Chitosan % 50 by electrospun method

[0032] FIG. 7. Implant figures of PP mesh coated with polyester/polysaccharide blend system by electrospun method

[0033] FIG. 8. Photographs of in vivo studies containing PP mesh implant

[0034] FIG. 9. Photographs of in vivo studies of PP mesh coated with PLGA/Chitosan % 30

DETAILED DESCRIPTION OF THE EMBODIMENTS

[0035] In the present invention, biocompatible, antibacterial, hemostatic and anti-adhesive meshes for intraperitoneal and extraperitoneal applications were developed. Details of production steps and resulting products are indicated below.

[0036] Process Steps:

[0037] Step 1. Preparation of Solutions and Blend System [0038] 4% weight solution of chitosan and PLGA was prepared in HFIP solvent and stirred with a magnetic stirrer for 12 h at ambient conditions. Polysaccharide ratio is about 30% of the total material in prepared blend system. The filtration was performed to remove the dissolved chitosan particles. [0039] 6% weight solution of chitosan and PLGA was prepared in HFIP solvent, stirring with a magnetic stirrer for 12 h at ambient conditions. Polysaccharide ratio is about 10% of the total material in prepared blend system. The filtration was performed to remove the dissolved chitosan particles.

[0040] Step 2. Application of Electrospun Blend System [0041] Solution and blend systems were put into syringe and it was placed in a pump of electrospun device. PP mesh was coated on the aluminum cylinder then; optimized parameter values of voltage, the distance between needle tip and collector and flow rate were applied. Fiber structure was homogeneously collected on the PP mesh with the rotation of the aluminum cylinder. After the desired amount of product collected, bilayer mesh is completely dried at 40 C. vacuum oven for 1 day. [0042] The present invention is detailed in the above examples, but is not limited to the examples described herein.