Surgical implant and process of manufacturing thereof
A surgical implant ( 20 ) comprises a flexible, areal basic structure ( 22 ) having a first face and a second face and being provided with pores ( 26 ) extending from the first face to the second face. A barrier layer ( 24 ) having a first face and a second face is placed, with its second face, at the first face of the basic structure ( 2 ) and attached to the basic structure ( 22 ). The barrier layer ( 24 ) is deformed into at least part of the pores ( 26 ) where it forms, in a respective pore ( 10 ), a barrier region ( 28 ).
1. A surgical implant, comprising
a flexible, areal basic structure comprised of a flat, biocompatible, polymeric, woven mesh having a first face and a second face and being provided with pores extending from the first face to the second face, and
a barrier layer comprising only a single synthetic, resorbable polymer film, the barrier layer having a first face and a second face and being placed, with its second face, at the first face of the basic structure and being attached to the basic structure without being folded over the basic structure,
wherein the barrier layer is deformed into at least part of the pores where it forms, in a respective pore, a barrier region such that the second face of the barrier layer is closer to the second face of the basic structure than the first face of the barrier layer is to the first face of the basic structure, and such that the second face of the barrier layer is exposed through the second face of the basic structure;
wherein the surgical implant is adapted for implantation within a patient's body and configured such that when placed against a tissue surface the second face of the areal basic structure and second face of the barrier layer both directly contact the same tissue surface to be repaired, and wherein when so implanted the barrier layer has an anti-adhesive effect that prevents bodily tissue from growing into the first face of the areal basic structure, and wherein the second face of the barrier layer that is exposed through the pores of the areal basic structure is adapted to cling to the tissue to be repaired but not prevent tissue ingrowth into the areal basic structure through the second face of the areal basic structure.
2. A surgical implant according to claim 1 , characterized by a bonding material having a melting temperature lower than the melting temperature of at least part of the material of the basic structure and lower than the melting temperature of at least part of the material of the barrier layer, wherein the bonding material comprises poly-p-dioxanone.
3. A surgical implant according to claim 1 , characterized in that the basic structure is designed in one of the following forms: a surgical mesh, a mesh-like sheet, a spacer fabric, a perforated film, a perforated woven, a perforated non-woven, a mesh pouch.
4. A surgical implant according to claim 1 , characterized in that the pores of the basic structure have a size in the range of from 1 mm to 9 mm.
5. A surgical implant according to claim 1 , characterized in that the barrier layer is provided with pores having a smaller size than that of the pores of the basic structure.
6. A surgical implant according to claim 1 , characterized in that the barrier layer, between pores of the basic structure, forms ridges where the first face of the barrier layer rises above the first face of the barrier layer in an adjacent barrier region by an amount in the range of from 50 μm to 900 μm.
7. A surgical implant according to claim 1 , characterized in that the basic structure comprises at least one non-absorbable material, the at least one non-absorbable material selected from the following list: polyalkenes, polypropylene, polyethylene, fluorinated polyolefins, polytetrafluoroethylene, PTFE, ePTFE, cPTFE, polyvinylidene fluoride, blends of polyvinylidene fluoride and copolymers of vinylidene fluoride and hexa-fluoropropene, polyamides, polyimides, polyurethanes, polyisoprenes, polystyrenes, polysilicones, polycarbonates, polyarylether ketones, polymethacrylic acid esters, polyacrylic acid esters, aliphatic polyesters, aromatic polyesters, copolymers of polymerizable substances thereof.
8. A surgical implant according to claim 1 , characterized in that the basic structure comprises at least one absorbable material, the at least one absorbable material selected from the following list: synthetic bioabsorbable polymer materials, polyhydroxy acids, polylactides, polyglycolides, copolymers of glycolide and lactide, copolymers of glycolide and lactide in the ratio 90:10, copolymers of glycolide and lactide in the ratio 5:95, copolymers of lactide and trimethylene carbonate, copolymers of glycolide, lactide and trimethylene carbonate, polyhydroxybutyrates, polyhydroxyvaleriates, poly-caprolactones, copolymers of glycolide and s-caprolactone, polydioxanones, poly-p-dioxanone, synthetic and natural oligo- and polyamino acids, polyphosphazenes, polyanhydrides, polyorthoesters, polyphosphates, polyphosphonates, polyalcohols, polysaccharides, polyethers, collagen, gelatin, bioabsorbable gel films cross-linked with omega 3 fatty acids, oxygenized regenerated cellulose.
9. A surgical implant according to claim 1 , characterized in that the polymer film comprises at least one absorbable material, the at least one absorbable material selected from the following list: copolymers of glycolide and s-caprolactone, collagens, gelatine, hyaluronic acid, polyvinyl pyrrolidone, polyvinyl alcohol, fatty acids, polyhydroxy acids, polyether esters, polydioxanones, copolymers of polymerizable substances thereof.
10. A surgical implant according to claim 1 , characterized by an orientation marker adapted for distinguishing the first face of the basic structure from the second face of the basic structure.
11. A surgical implant according to claim 1 , characterized in that the surgical implant is arranged to be placed with the second face of the basic structure and the second face of the barrier layer towards a patient's peritoneum.
12. A surgical implant according to claim 1 , characterized in that the average roughness, as defined in ASME B46.1-2009 and measured over that area of the basic structure where the barrier layer is deformed into pores of the basic structure, is smaller at the second faces of the barrier layer and the basic structure than at the first faces of the barrier layer and the basic structure.
13. A surgical implant according to claim 12 , characterized in that the ratio of the average roughness measured at the second faces of the barrier layer and the basic structure to the average roughness measured at the first faces of the barrier layer and the basic structure has a value in one of the following ranges: 0.0-0.1, 0.1-0.2, 0.2-0.3, 0.3-0.4, 0.4-0.5, 0.5-0.6, 0.6-0.7, 0.7-0.8, 0.8-0.9, 0.9-1.0.
14. A surgical implant according claim 1 , characterized in that said barrier region is basically flat.
15. A surgical implant according to claim 14 , characterized in that the angle between said barrier region and a plane in parallel to the second face of the basic structure is in the range of from 0° to 5°.
16. A surgical implant according to claim 14 , characterized in that said barrier region has a size in the range of from 0.5 mm to 5 mm and less than the size of the respective pore of the basic structure.
17. A process of intraperitoneally placing a surgical implant according to claim 1 in a patient's body, comprising the steps:
introducing the surgical implant via a trocar sleeve into the body,
deploying the surgical implant, the second face of the basic structure facing a patient's peritoneum,
clinging the surgical implant to the peritoneum,
fixing the implant on the peritoneum.