Monofilament, Surgical Mesh Having Improved Flexibility and Biocompatibility, and Process for Preparing the Same

Abstract

The present invention relates to a monofilament with a segmented pie structure formed by conjugated spinning of degradable polymers and non-degradable polymers, a hernia mesh having improved flexibility and biocompatibility, and a preparation method thereof. More specifically, the hernia mesh of the present invention having improved flexibility and biocompatibility is prepared using the monofilament obtained by conjugated spinning of degradable polymers and non-degradable polymers into a segmented pie form, to control it to be gradually degraded in the body, whereby the stiffness of the early stage is removed, and thereby the foreign body sensation is also removed.

1 . A monofilament having a segmented pie structure formed by conjugated spinning of a degradable polymer and a non-degradable polymer.  
   
   
       2 . The monofilament according to  claim 1 , wherein the content of the degradable polymer is 30 to 70 vol %, and the content of the non-degradable polymer is 30 to 70 vol %.  
   
   
       3 . The monofilament according to  claim 1 , wherein the degradable polymer is a homopolymer or copolymer comprising one or more monomers selected from the group consisting of glycolide, glycolic acid, lactide, lactic acid, caprolactone (ε-caprolactone), dioxanone (p-dioxanone), trimethylene carbonate, polyanhydride, and polyhydroxyalkanoate (PHA).  
   
   
       4 . The monofilament according to  claim 3 , wherein the degradable polymer is a glycolide/caprolactone copolymer or a dioxanone/trimethylenecarbonate/caprolactone copolymer.  
   
   
       5 . The monofilament according to  claim 1 , wherein the non-degradable polymer is selected from the group consisting of polyolefins, polyamides, polyurethanes, and fluoropolymers.  
   
   
       6 . The monofilament according to  claim 5 , wherein the non-degradable polymer is polypropylene, or a copolymer of propylene and ethylene.  
   
   
       7 . The monofilament according to  claim 1 , wherein the melt index of the degradable polymer is not lower than the melt index of the non-degradable polymer.  
   
   
       8 . The monofilament according to  claim 7 , wherein the difference between the melt indexes of the degradable polymer and the non-degradable polymer is 10 or less.  
   
   
       9 . The monofilament according to  claim 1 , wherein the non-degradable polymer is divided into at least four strands.  
   
   
       10 . A method of using the monofilament according to  claim 1  in hernia repair, vaginal sling procedures, artificial ligament and tendon operations, or repairing fascial deficiencies that require addition of an reinforcing material or a bridging material.  
   
   
       11 . A hernia mesh having improved flexibility and biocompatibility, comprising a monofilament having a segmented pie structure formed by conjugated spinning of a degradable polymer and a non-degradable polymer.  
   
   
       12 . The hernia mesh according to  claim 11 , wherein the content of the degradable polymer is 30 to 70 vol %, and the content of the non-degradable polymer is 30 to 70 vol %.  
   
   
       13 . The hernia mesh according to  claim 11 , wherein the degradable polymer is a homopolymer or a copolymer comprising one or more monomers selected from the group consisting of glycolide, glycolic acid, lactide, lactic acid, caprolactone (ε-caprolactone), dioxanone (p-dioxanone), trimethylenecarbonate, polyanhydride, and polyhydroxyalkanoate.  
   
   
       14 . The monofilament according to  claim 13 , wherein the degradable polymer is a glycolide/caprolactone copolymer or a dioxanone/trimethylenecarbonate/caprolactone copolymer.  
   
   
       15 . The monofilament according to  claim 11 , wherein the non-degradable polymer is selected from the group consisting of polyolefins, polyamides, polyurethanes, and fluoropolymers.  
   
   
       16 . The monofilament according to  claim 15 , wherein the non-degradable polymer is polypropylene, or a copolymer of propylene and ethylene.  
   
   
       17 . The monofilament according to  claim 11 , wherein the melt index of the degradable polymer is not lower than the melt index of the non-degradable polymer.  
   
   
       18 . The monofilament according to  claim 17 , wherein a difference between the melt indexes of the degradable polymer and the non-degradable polymer is 10 or less.  
   
   
       19 . The monofilament according to  claim 11 , wherein the non-degradable polymer is divided into at least four strands.  
   
   
       20 . The monofilament according to  claim 11 , wherein the diameter of the monofilament is 100 to 250 μm.  
   
   
       21 . The hernia mesh according to  claim 11 , wherein the stiffness of the degradable polymer after degradation is decreased at least 70% compared with that before degradation.  
   
   
       22 . The hernia mesh according to  claim 11 , wherein the non-degradable polymer is partitioned by the degradable polymer, and the degradable polymer has a continuous form.  
   
   
       23 . The hernia mesh according to  claim 11 , wherein the structure of the mesh is a square, hexagonal, or network structure.  
   
   
       24 . The hernia mesh according to  claim 11 , wherein the pore size is 0.1 to 4.0 mm and the thickness is 200 to 800 μm,  
   
   
       25 . The hernia mesh according to  claim 11 , wherein the density is 8 to 20 gauges/inch based on the distance between the needles in a warp knitting machine.  
   
   
       26 . The hernia mesh according to  claim 11 , wherein the degradable polymer is partially dyed.  
   
   
       27 . A method of preparing a hernia mesh, comprising the steps of spinning, solidification, crystallization, and drawing to prepare a monofilament, and the steps of warping, knitting, and curing to prepare the hernia mesh, wherein: 
 the spinning step is performed by melting 30 to 70 vol % of a degradable polymer and 30 to 70 vol % of a non-degradable polymer, and conducting conjugated spinning to form a segmented pie structure;    the drawing step is performed by applying stress-relaxation to prepare the monofilament; and    the curing step is performed at 90 to 160° C. for 1 to 30 minutes.    
   
   
       28 . The method according to  claim 27 , wherein stress-relaxation of at least 10% is applied.