KR100970738B1 - Surgical mesh fabricated with hollow fibers, and nethof of fabricating the same - Google Patents

Abstract

The present invention relates to a surgical mesh and a method for manufacturing the same, and more particularly, having a hollow cross-sectional shape having a continuous hole in the longitudinal direction of the fiber, excellent rigidity, less weight per unit area, the operation convenience and living body The present invention relates to a surgical mesh having improved compatibility and a method of manufacturing the same.

Description

Surgical mesh made of hollow fiber and manufacturing method thereof {SURGICAL MESH FABRICATED WITH HOLLOW FIBERS, AND NETHOF OF FABRICATING THE SAME}

1 is a schematic view showing a cross section of a hollow monofilament according to the present invention.

Figure 2 is a schematic diagram schematically showing a spinning process of the hollow monofilament according to the present invention.

3A, 3B and 3C are schematic views showing the shape of a nozzle forming a cross section of the hollow fiber used in the present invention.

4A is an electron micrograph of a surgical mesh having a rhombus shaped hole made of polypropylene hollow monofilament, and FIG. 4B is an electron micrograph of a surgical mesh having a hexagonal shaped hole made of polypropylene hollow monofilament.

*** Description of the main parts of the drawing ***

21: Extruder 22: Metering Pump

23: spinning block 24: monofilament

25: cooling tank 26: drawing device

27: winder

The present invention relates to a surgical mesh and a method for manufacturing the same, and more particularly, having a hollow cross-sectional shape having a continuous hole in the longitudinal direction of the fiber, excellent rigidity, less weight per unit area, the operation convenience and living body The present invention relates to a surgical mesh having improved compatibility and a method of manufacturing the same.

Tension-free herniation using mesh (Lichtenstein IL, The tension-free hernioplasty, Am J Surg. 1989; 157; 188-193) has a low recurrence rate, shorter surgical time, and wound recovery time. It is fast and has the advantage of allowing patients to return to their daily routines quickly, and has been accepted as a useful method for hernia surgery.

In general, polypropylene monofilaments are typically used as the material because the mesh used for hernia surgery should have the property of strengthening the peritoneum by maintaining chemical and physical properties for many years. U.S. Patent Nos. 4347847, 6287316 and the like relate to a method for producing a hernia surgical mesh composed of polypropylene monofilament. Such polypropylene mesh has good initial stiffness and strength for the convenience of surgery, but side effects such as restriction of fluidity due to stiffness of the peritoneum, consequent foreign body and pain, and chronic inflammatory reaction between polypropylene fiber and tissue are reported. have. (Seelig MH, A rarecomplication after incisional hernia repair. Chirurg 1995; 66 (7); 739-741, Leber GE, Long-term complications associated with prosthetic repair of incisional hernias, Arch Surg 1988; 133 (4); 378-382, Amid PK, Biomaterials for abdominal wall hernia surgery and principles of their applications, Lagenbecks Arch Chir 1994; 379 (3): 168-171, Waldrep DJ, Mature fibrous cyst formation after Marlex Vestweber K, Results of recurrent abdominal wall hernia repair using polypropylene mesh. Zentralblatt Fur Chirurgie 1997; 122: 885-8, Bellon JM, Integration of biomaterials implanted into abdominal wall: mesh ventral herniorrhaphy: a newly described pathologic entity.Am Surg 1993; 59 (11): 716-8, process of scar formation and macrophage response.Biomaterials 1995; 16 (5): 381-7, Klinge U, Changes in abdominal wall mechanics after mesh implantation.Experimental changes in mesh stability.Lagenbecks Arch Chir 1996; 381 (6): 323-32).

In order to reduce the side effects after the hernia surgery using such a mesh, a method for producing a lightweight polypropylene mesh to reduce the amount of foreign matter remaining in the body in order to impart fiber flexibility and improve biocompatibility has been studied. However, the existing lightweight polypropylene mesh has a low rigidity due to excessive flexibility of the mesh, and it is very inconvenient for a surgical operation to fix the initial mesh to the wound.

In order to overcome this problem, instead of lowering the content of polypropylene, it is necessary to reinforce the strength and stiffness needed initially with biodegradable material so that the part is decomposed after wound healing, so that the mesh is flexible and the content of foreign matter remaining in the body is reduced. Research has been conducted on meshes (US Pat. Nos. 4652264 and 6162962, Korean Patent Publication No. 10-2006-0076252). However, the partially degradable surgical mesh has a disadvantage in that the manufacturing cost is expensive because it uses an expensive biodegradable polymer.

Until now, the use of the hernia surgical mesh has been established as a basic surgical method for hernia surgery. However, the non-degradable hernia surgical mesh which has the advantages such as convenience of surgery, relief of foreign body feeling and biocompatibility is improved. The research was not successful. Therefore, there is a need to develop a lightweight mesh to reduce the content of foreign matter remaining in the body initially with strength and rigidity for surgical convenience.

The present invention is to solve the problems of the existing surgical mesh as described above, by using a hollow fiber with a small weight per unit area and a relatively high bending rigidity compared to the circular cross-sectional fiber for lightweight surgical The purpose is to provide a mesh.

Still another object of the present invention is to provide a method for manufacturing a lightweight surgical mesh with improved rigidity using hollow fiber.

The present invention relates to a lightweight surgical mesh which is excellent in rigidity and has a low weight per unit area, which is manufactured using a biocompatible polymer and has a hollow cross-sectional shape in which a continuous hole is formed in the longitudinal direction of the fiber.

In another aspect, the present invention is a method for producing a surgical mesh by producing a monofilament by spinning, solidification, crystallization and stretching process, canon, warp, heat treatment, melting the biocompatible polymer during the spinning It relates to a method for producing a surgical mesh characterized in that the spinning to have a hollow cross-sectional shape in which a continuous hole is formed in the longitudinal direction of the fiber.

Hereinafter, the present invention will be described in detail.

Biocompatible polymers used in the present invention may be polypropylene, polyethylene, polyolefins such as copolymers of propylene and ethylene, or polyamides such as nylon 6, nylon 66, etc., fluoro polymers such as polyurethane, polyvinylidene fluoride, and the like. And preferably is polypropylene or a copolymer of propylene and ethylene.

The fiber constituting the surgical mesh of the present invention is hollow fiber having a continuous hole in the fiber long axis direction inside the fiber.

As used in the present invention, hollow fiber, hollow fiber, hollow filament and hollow monofilament all mean a mesh configuration yarn having a hollow cross-section with a continuous hole in the longitudinal direction as described above.

These hollow yarns are somewhat different depending on the hollow ratio, but the bending stiffness of the fiber is higher than that of the circular cross-sectional fiber of the same diameter while having a lower weight per unit area. When the surgical mesh is made of hollow fiber having such characteristics, the weight is reduced and the biocompatibility is improved, and the rigidity is high compared to the conventional commercially available lightweight mesh, and the convenience of the procedure is improved.

In the present invention, as shown in Fig. 1, the hollow fiber has a continuous hole in the major axis of the fiber as shown in Fig. 1.

In the present invention, the hollow ratio of the hollow fibers constituting the mesh is preferably 5% to 60%, and considering the fiber spinning and hollow holding stability, the hollow ratio is preferably 10% to 40%, more preferably 20 More preferably 40%. Further, the number of holes continuous in the long axis direction formed in the hollow fiber constituting the mesh of the present invention is not limited in number as long as it satisfies the hollow ratio as described above, and is suitable for maintaining rigidity and manufacturing suitable to be manufactured as a surgical mesh. In consideration of convenience, the number of continuous holes in the long axis in the hollow fiber is preferably 1 to 20, preferably 1 to 8.

In addition, the hollow fibers constituting the mesh of the present invention may be in the form of a monofilament or multifilament, and in a preferred embodiment, it is more preferred that the monofilament is a lower risk of postoperative tissue infection than multifilament. In an embodiment of the present invention, the diameter of the monofilament can be appropriately adjusted in consideration of physical properties such as strength, surgical convenience, and biocompatibility for surgical satisfaction. In this respect, the monofilament used in the present invention may have a diameter of 100 to 250 μm, and preferably 130 to 170 μm.

As described above, the filaments constituting the surgical mesh of the present invention is obtained in the form of hollow fibers and described in more detail as follows:

Figure 2a schematically shows a monofilament complex spinning process, one of the methods for producing a filament used in the surgical mesh of the present invention, having a structure of a conventional spinner. Looking at this in detail, the extruder 21 is used to melt the biocompatible polymer. The molten polymer is discharged by the desired amount through the metering pump 22. The molten polymer discharged through the metering pump 22 is spun into the monofilament 24 through the spinning block 23. The spun monofilament 24 is solidified and crystallized in the cooling bath 25. At this time, the air gap between the discharge port of the spinning block 23 and the surface of the cooling tank is preferably 0.5 to 100 cm, more preferably 1 to 30 cm. The filaments solidified in the cooling bath are stretched through the conventional drawing device 26 and wound up in the winder 27 in order to obtain physical property improvement by the orientation.

3A, 3B, and 3C show examples of the form of spinnerets of nozzles that can be used in the spinning block 23 that can form a hollow cross section of the present invention. When spinning using the spinneret having the form of Figures 3a and 3b), it is possible to produce a hollow fiber having one hole in the cross-section of the fiber, and when spinning using the spinneret having the form of Figure 3c four holes It is possible to produce a hollow yarn having.

Using the hollow fiber obtained through the manufacturing process as described above, the mesh of the present invention can be basically produced in a variety of forms of tissue. For example, the mesh of the present invention may be made in the form of circular knit, warp knitted, woven or nonwoven fabrics. In order to reduce the foreign body feeling after surgery, to prevent the shrinkage of the mesh to be inserted, and to minimize the side effects such as tissue infection, the mesh of the present invention must be at least 75 μm, so that the mesh of the present invention It is preferable. The pore size of the mesh of the present invention is 0.1 to 4 mm, 0.2 to 3.0 mm, the thickness is 200 to 800 ㎛, preferably 500 to 700 ㎛.

In addition, since the hollow fiber used in the present invention has a higher bending rigidity while having a lower weight per unit volume than a monofilament having a circular cross section of the same diameter, the mesh made of the filament having the hollow cross section of the present invention It has the advantage that the weight per unit area is reduced to reduce the weight. In an embodiment of the present invention, the mesh has a weight of 10 g / m ² to 100 g / m ² , more preferably 15 g / m ² to 60 g / m ² .

In addition, when the doctor cuts and uses the mesh according to the size and shape of the patient's wound, debris may be generated or loosened at the edge of the mesh, so that the tissue of the mesh is a tissue that is loosened or broken when cut. It is not preferable, and the square, hexagon, net structure, etc. of a net structure are preferable at the point which makes the debris at the time of mesh cutting small. As an example, the shape of the mesh made of a warp knitting machine is shown in Figures 4a and 4b.

The prepared mesh may be heat treated to fix the shape of the surgical mesh. The heat treatment temperature and time can be appropriately adjusted so that there is no change in properties and yellowing after the heat treatment, and in general, the treatment is performed for 1 to 30 minutes at a temperature of 10 to 15 ° C. lower than the melting point of the mesh component to be heat treated, that is, 90 to 160 ° C. Good to do.

Compared to the conventional non-degradable mesh, the mesh produced in the present invention has a greatly reduced content per unit area, and thus has improved biocompatibility. It is particularly well suited for hernia surgery. In addition, the surgical mesh produced using the hollow fiber of the present invention is not only for hernia surgery. It can also be useful as a mesh for treating artificial ligament or tendon surgery, vaginal sling material, or fascial deficiencies that require the addition of reinforcing or connecting materials.

Hereinafter, the present invention will be described in more detail with reference to the following examples, but these examples are merely to illustrate the present invention, and the scope of the present invention is not limited to these examples.

[ Example ]

Example  One

Using isotactic polypropylene as a biodegradable polymer, and using a hollow nozzle of the form of Figure 3a, under the conditions of Table 1 below, a monofilament having a hollow cross section was prepared. Using the hollow fiber prepared as described above, a mesh was prepared by warping the mesh having a rhombus shape by heat treatment at 140 ° C. for 10 minutes.

Example  2

Isotic polypropylene was used as the biodegradable polymer, and a monofilament having a hollow cross section was prepared under the conditions of Table 1 below using a hollow nozzle of FIG. 3C. Using the hollow fiber prepared as described above, a mesh was prepared by warping the mesh having a rhombus shape by heat treatment at 140 ° C. for 10 minutes.

Example  3

Using a random copolymer of propylene (97% by weight) / ethylene (3% by weight) as a biodegradable polymer, using a hollow nozzle of the form of Figure 3c, to prepare a monofilament having a hollow cross section under the conditions of Table 1 below It was. Using the hollow fiber prepared as described above, a mesh was prepared by warping the mesh having a rhombus shape by heat treatment at 140 ° C. for 10 minutes.

The spinning, stretching and mesh manufacturing conditions of Examples 1 to 3 are summarized in Table 1 below.

TABLE 1

Example  4

A mesh was manufactured by the same method as Example 2, except that the shape of the mesh structure was hexagonal.

Comparative example  One

A mesh was manufactured in the same manner as in Example 1 except that the nozzle was a hollow circular cross-sectional nozzle instead of hollow, and the rotation speed of the metering pump was 10.6.

Comparative example  2

A conventional mesh product (Prolene Hernia mesh, Ethicon co.) Prepared using a polypropylene monofilament of circular cross section was prepared.

Comparative example  3

A conventional lightweight mesh product (Serapren, SERAG co.) Manufactured using a polypropylene monofilament of circular cross section was prepared.

Test Example  One: Monofilament  Property evaluation

The physical properties of the monofilaments prepared in Examples 1 to 4 and Comparative Examples 1 to 3 were evaluated. The physical property evaluation method of the monofilament in this test example is summarized in the following Table 2.

TABLE 2

Properties Measurement method and instrument Diameter (mm) EP regulat on diameter gauge Hollowness (%) It measured by following [Equation 1]. Tensile strength (kgf) EP regulations, tensile strength, Instron co. Stiffness, (mgf) Gather 10 fibers of 1 inch length and divide them into 10 by measuring 5g position 2 in the rigidity tester.

[Equation 1]

Physical properties of the monofilament measured as described above are shown in Table 4 below.

Test Example  2: Mesh  Property evaluation

The physical properties of the meshes prepared in Examples 1 to 4 and Comparative Examples 1 to 3 were evaluated. The evaluation method of the physical properties of the mesh in this test example is summarized in Table 3 below.

[Table 3]

Properties Measuring method and measuring instrument Weight (g / m2) 10 cm x 10 cm mesh is measured and converted Tensile strength (kgf / inch) Tensile distance at the tensile strength tester (Instron co.) By sampling a 1 inch by 5 inch mesh in the horizontal or vertical direction during warp knitting
Measured under 50mm and 50mm / min tensile speed Stiffness (mgf) Cut the mesh to 1 inch x 1 inch and measure it with a load of 5 g and position 2 on a Gurley precision instrument.

Physical properties of the mesh measured as described above are shown in Table 4 below.

Property evaluation result

Property evaluation results of the monofilament and the mesh measured in Test Examples 1 and 2 are shown in Table 4 below.

[Table 4]

As shown in Table 4, looking at the physical properties according to Examples 1 to 4 and Comparative Examples 1 to 3, the mesh made of a monofilament having a hollow cross section of the present invention is made of a monofilament having a circular cross section of the same diameter Compared to a single mesh, the weight is lower, so that the biocompatibility is improved, and the stiffness is higher than that of the existing lightweight mesh of similar weight.

That is, when comparing Example 2 and Comparative Example 1, when the same polypropylene is used, when the mesh is manufactured under the same conditions and the diameter of the same fiber, the mesh produced using a monofilament having a hollow cross section of the present invention The weight was greatly reduced by 20% to 30% than the mesh made of monofilament of circular cross section, and the rigidity was improved by about 10%, so that a light weight mesh having a low weight could be manufactured without reducing the rigidity required for the convenience of the procedure.

In addition, when comparing Examples 1 to 4 and Comparative Example 2, the mesh made of a monofilament having a hollow cross-section of the present invention is lower in weight than the existing general polypropylene mesh, the foreign matter remaining in the patient's body It can be seen that the biocompatibility is improved by greatly reducing the amount.

In addition, when compared with Examples 1 to 4 and Comparative Example 3, the mesh made of a monofilament having a hollow cross section of the present invention is similar in weight to the conventional lightweight mesh and the rigidity for the operation convenience because of high surgical convenience It can be seen that greatly improved.

As described above, the present invention by manufacturing the surgical mesh with hollow fiber, the rigidity is improved and the weight of the mesh is low, it is possible to manufacture a surgical mesh with improved surgical convenience and improved biocompatibility.

Claims (11)

The biocompatible polymer includes a monofilament having a hollow cross section manufactured to form a continuous hole in the longitudinal direction of the filament, The monofilament having a hollow cross section has a hollow ratio of 5 to 60%, The weight per unit area of the mesh is from 10 g / m ² to 100 g / m ² , Lightweight hernia surgical mesh with excellent rigidity. It comprises a monofilament having a hollow cross section prepared by spinning the biocompatible polymer to form a continuous hole in the longitudinal direction of the filament, The monofilament having a hollow cross section has a hollow ratio of 5 to 60%, The weight per unit area of the mesh is from 10 g / m ² to 100 g / m ² , Lightweight, vaginal sling procedures with excellent rigidity, artificial ligament or tendon surgery, or treatment mesh for fascial deficiencies that require the addition of strengthening or connecting materials. The mesh of claim 1 or 2, wherein the biocompatible polymer is selected from the group consisting of polypropylene, polyethylene, polyolefins, polyamides, polyurethanes, and fluoropolymers. delete The mesh according to claim 1 or 2, wherein the filament having a hollow cross section is a monofilament having a diameter of 100 to 250 μm. delete A mesh according to claim 1 or 2, wherein the mesh has a pore size of 0.1 to 4 mm and a thickness of 200 to 800 μm. The mesh according to claim 1 or 2, wherein the hole shape of the mesh is square, hexagonal or reticulated. The mesh of claim 8 having a circular knit, warp knitted, woven, or nonwoven form. In the method of manufacturing a monofilament by spinning, solidification, crystallization and drawing process, and performing a canon, warp, heat treatment to produce a surgical mesh, Melting the biocompatible polymer to spin to form a continuous hole in the long axis direction of the fiber to produce a monofilament having a hollow cross section, Preparing a mesh by warping the monofilament; The method for producing the mesh of claim 1. The method of claim 10, further comprising treating the prepared mesh at 90 to 160 ° C. for 1 to 30 minutes after preparing the mesh by warping the monofilament.

Images