Prosthetic porous knit, method of making same and hernia prosthesis

The present invention relates to a porous knit for a prosthesis useful in body wall surgery, which has a lightweight, macroporous structure while exhibiting good mechanical strength properties.

Wall reinforced prostheses (eg, prostheses for reinforcing the abdominal wall) are widely used in the surgical field. These prostheses are intended to treat hernias by temporarily or permanently filling in tissue defects. These prostheses are generally made from biocompatible prosthesis fabrics, especially prosthesis knits, and have many shapes (eg, rectangular, circular, or oval) depending on the anatomy to which they should fit. Can have.

Considering reducing the amount of foreign material transplanted into the patient's body, it is desirable to create a lightweight knit that is intended to be used as a wall reinforcement prosthesis. In addition, it is further desired that the prosthesis knit exhibit good fluoroscopy in order to facilitate the surgeon's work when the surgeon places the prosthesis in place at the implantation site. In addition, wall reinforced prostheses should also favor good tissue inward growth. In this regard, it is hoped that the knit used for the wall reinforcement prosthesis will exhibit multiple holes, and preferably large holes.

Lightweight porous knits that can be used in the manufacture of wall reinforcement prostheses already exist. Nevertheless, they occasionally exhibit insufficient mechanical strength. In fact, knits are generally flexible and soft when transplanted because they adapt to the abdominal wall and bend as the abdominal wall moves. The knit can be held in place by suturing, stapling, or sticking the knit to the surrounding biological tissue. In particular, existing lightweight porous knits may exhibit insufficient resistance to breakage when they are sewn or attached to the surrounding biological tissue.

In addition, the performance of abdominal wall hernia repair using a prosthesis knit that is secured to the abdominal wall depends in part on the shear forces experienced at the knit fixation point. These shear forces can be very high as a result of high abdominal pressure.

When a knit or prosthesis is implanted and secured in the abdominal wall, for example by sutures, too high a shear force at the knit fixation point can lead to recurrence of abdominal wall repair and / or cause pain in the patient. The distribution of shear forces at fixed points is important for assessing the safety and efficacy of abdominal wall repair.

In particular, as much as possible the distribution of shear forces at the fixation point so that the prosthesis can be introduced and implanted at the implantation site, for example, without the surgeon having to look at a particular position in the direction of the warp or weft of the knit. It is desirable to provide a prosthesis made from a knit that is regular and has as low a shear force value as possible at the fixation point. It is further desirable to provide a prosthesis made from a knit that reduces the risk of fixation pull-out and / or the risk of implant damage at the fixation point.

In addition, if the knit is too flexible and too soft, it may not sufficiently resist intra-abdominal pressure during certain movements of the patient (eg, if the patient coughs or jumps). Secondly, the knit may be prone to suffer from undesired bulging phenomena and under such conditions may not ensure sufficient reinforcement of the abdominal wall.

Therefore, there is a need for a knit for a porous prosthesis that is lightweight and has a macroporous structure, but at the same time can exhibit good mechanical strength properties.

<p> The first aspect of the present invention is a porous knit for a prosthesis based on a monofilament of a biocompatible polymer material, the pattern followed for knitting the monofilament in a knitting machine having two guide bars B1, B2. According to the ISO 11676 standard: -Bar B1: 1.2 / 4.5 / 4.3 / 4.5 / 4.3 / 1.0 / 1.2 / 1.0 //-Bar B2: 4.3 / 1.0 / 1.2 / 1.0 / 1.2 / 4.5 / 4.3 / 4.5 // is there.</p><p> Another aspect of the present invention is a method for producing the above prosthesis knit, which, in accordance with ISO 11676 standards, in a knitting machine with two guide bars B1, B2, has the following pattern: -bar In monofilament of biocompatible polymer material according to B1: 1.2 / 4.5 / 4.3 / 4.5 / 4.3 / 1.0 / 1.2 / 1.0 //-bar B2: 4.3 / 1.0 / 1.2 / 1.0 / 1.2 / 4.5 / 4.3 / 4.5 // Includes steps to create a knit.</p><p> Guide bars B1 and B2 can be pierced with 1 full and 1 empty and can move symmetrically.</p><p> The knitting machine can be a vertical knitting machine or a Rachel knitting machine.</p><p> The knit of the present invention is porous. In particular, the knits of the present invention include openings or holes, and these openings or holes are produced in particular by the pattern followed for knitting monofilaments of knits according to the present invention. The porosity of the knits of the present invention gives the knits transparency and allows the surgeon to have good visibility of the implant site when the knit or prosthesis is in place.</p><p> The knit of the present invention is lightweight. The knit of the present invention is approximately 40 g / m when measured in accordance with ISO 3801: 1977 "Mass determination per unit length and mass per unit area".²~ About 70g / m²Mass per unit area over the range of, preferably about 40 g / m²~ About 50g / m²Mass per unit area over the range of, more preferably about 44 g / m², 45g / m², 46g / m², 47g / m², Or 48g / m²Preferably shows the mass per unit area of (5 samples, 1 dm)²). Such a low mass per unit area allows the introduction of only small amounts of foreign material into the patient's body.</p><p> The knit of the present invention is made from a monofilament of a biocompatible polymeric material.</p><p> The biocompatible polymer can be synthetic or natural. The biocompatible polymer can be biodegradable, non-biodegradable, or a combination of biodegradable and non-biodegradable. The term "biodegradable", as used herein, is defined to include both bioabsorbable and reabsorbable materials. Biodegradability means that a material loses its structural integrity under physical conditions, such that the material decomposes spontaneously, or the decomposition products are excretable or absorbable by the body. It is meant to be (eg, enzymatically degraded or hydrolyzed) or destroyed (physically or chemically) under physiological conditions in the body.</p><p> The biocompatible polymer can be selected from the group consisting of biodegradable polymers, non-biodegradable polymers, and combinations thereof.</p><p> In embodiments, the biocompatible polymeric material is polypropylene, polyester, eg, polyethylene terephthalate, polyamide, silicone, polyetheretherketone (PEEK), polyaryletherketone (PAEK), polylactic acid (PLA), polycaprolactone (PCL). ), Polydioxanone (PDO), Trimethylene carbonate (TMC), Polyvinyl alcohol (PVA), Polyhydroxyalkanoate (PHA), Polyglycolic acid (PGA), Copolymers of these materials, and mixtures thereof.</p><p> In embodiments, the biocompatible polymeric material is polypropylene.</p><p> In embodiments, the monofilament has a diameter of about 0.08 mm to about 0.25 mm, preferably about 0.10 mm to about 0.15 mm, more preferably about 0.11 mm, about 0.12 mm, or about 0.13 mm. Such a diameter makes it possible to obtain well sized holes and maintain the lightweight construction of the knit, while maintaining good mechanical properties. In embodiments, the monofilament has a diameter of about 0.12 mm.</p><p> In embodiments, the knit comprises a plurality of holes having a diameter greater than 1 mm. In particular, the plurality of holes having a diameter of more than 1 mm defines the effective porosity of the knit in the range of about 35% to about 70%, preferably about 55%.</p><p> "Effective porosity" means, according to the present application, porosity excluding pores having a diameter greater than 1 mm, while pores having a diameter smaller than or equal to 1 mm. "Hole with a diameter greater than 1 mm" means a hole having a size greater than 1 mm in all directions. Therefore, the effective porosity corresponds to the ratio of the total area of holes with diameters greater than 1 mm as defined above to the total area of the knit studied. Holes with diameters greater than 1 mm are measured with a profile projector (eg, projector 300V from ORAMA). "Effective Porosity" and its measurement method are described in the publication "New objective measurements to characterize the porosity of textile implants", T. Muhl, M. Binnebosel, U. Klinge and T. Goedderz, Journal of Biomedical Materials Research Part B: Applied It is described in Biomaterials, p.176-183.</p><p> Effective porosity as described above is useful for characterizing the ability of knits to favor cell colonization. In fact, pores with diameters greater than 1 mm are particularly desired for tissue inward growth after transplantation.</p><p> The knit knitting pattern of the present invention defines a plurality of holes having a diameter extending over 1 mm. The holes can have a substantially hexagonal or circular shape.</p><p> In embodiments, the knit of the present invention comprises a plurality of holes having a diameter greater than 2 mm. Such knits with holes with diameters greater than 2 mm favor cell colonization, show good fluoroscopy, and when the surgeon places the knit / prosthesis in place at the implantation site, the surgeon can twist the surrounding tissue. Allows you to have good visibility.</p><p> In embodiments, the knit of the present invention has a tensile breaking strength in the warp direction of at least about 200 N, preferably about 237 N. In embodiments, the knit of the present invention has a tensile breaking strength in the weft direction of at least about 170 N, preferably about 201 N. In embodiments, the knits of the invention have a burst strength of at least about 400 kPa, preferably about 463 kPa. In embodiments, the knit of the present invention has a warp tear strength of at least about 25 N, preferably about 30 N. In embodiments, the knits of the invention have a tear strength in the weft direction of at least about 25N, preferably about 37N. In embodiments, the knit of the present invention has a suture pull-out strength of at least about 35 N, preferably about 46 N in the warp direction. In embodiments, the knits of the invention have a suture pull-out strength of at least about 38N, preferably about 42N in the weft direction. In embodiments, the knit of the present invention has a tensile strength of at least about 42 N / cm, preferably about 47 N / cm.</p><p> The above tensile strength at break (N), burst strength (kPa), tear strength (N), suture pull-out strength (N), and tensile strength (N / cm) are methods as shown in the examples of the present application below. Measured according to.</p><p> After knitting and heat setting, the knit can be cleaned, packaged, and sterilized using previously known techniques. The knits of the present invention can be used as provided in the package or can be cut to any desired size when removed from the package.</p><p> The knits of the present invention can be implanted externally to the peritoneum for repair of either a scrotum or abdominal wall hernia via an open or laparoscopic approach. Fixation to surrounding tissue can be achieved by stapling, conventional suturing, or other means.</p><p> The prosthesis knit of the present invention exhibits a uniform distribution of shear forces at fixed points. In particular, the prosthesis knit of the present invention has a lightweight structure, but the prosthesis knit of the present invention exhibits good resistance to breakage at a fixed point as compared to the lightweight knit of the prior art.</p><p> The knits of the present invention can be used alone as a prosthesis to be implanted in a patient, for example for hernia repair.</p><p> Another aspect of the invention is a hernia prosthesis containing a knit as described above.</p><p> The present invention becomes clearer from the following description and from the accompanying drawings.</p><p> The present invention provides, for example, the following items. (Item 1) A porous knit for a prosthesis based on a monofilament of a biocompatible polymer material, the pattern followed for knitting the monofilament on a knitting machine having two guide bars B1 and B2 is in accordance with ISO 11676 standards. ,Less than: -Bar B1: 1.2 / 4.5 / 4.3 / 4.5 / 4.3 / 1.0 / 1.2 / 1.0 //-Bar B2: 4.3 / 1.0 / 1.2 / 1.0 / 1.2 / 4.5 / 4.3 / 4.5 //, porous knit for prosthesis .. (Item 2) The biocompatible polymer material is polypropylene, polyester, for example, polyethylene terephthalate, polyamide, silicone, polyetheretherketone (PEEK), polyaryletherketone (PAEK), polylactic acid (PLA), polycaprolactone (polycaprolactone). Selected from PCL), polydioxanone (PDO), trimethylene carbonate (TMC), polyvinyl alcohol (PVA), polyhydroxyalkanoate (PHA), polyglycolic acid (PGA), polymers of these materials, and mixtures thereof. , The porous knit for the prosthesis described in the above item. (Item 3) The porous knit for a prosthesis according to any one of the above items, wherein the biocompatible material is polypropylene. (Item 4) The porous knit for a prosthesis according to any one of the above items, wherein the monofilament has a diameter of about 0.08 mm to about 0.25 mm, preferably about 0.10 mm to about 0.15 mm. (Item 5) The monofilament is a porous knit for a prosthesis according to any one of the above items, which has a diameter of about 0.12 mm. (Item 6) The porous knit for a prosthesis according to any one of the above items, which comprises a plurality of holes having a diameter of more than 1 mm. (Item 7) The porous knit for a prosthesis according to any one of the above items, which comprises a plurality of holes having a diameter of more than 2 mm. (Item 8) The plurality of holes define the effective porosity of the prosthesis porous knit in the range of about 35% to about 70%, preferably about 55% of the prosthesis porous knit. The porous knit for a prosthesis according to any one of the above items. (Item 9) The method for producing a porous knit for a prosthesis according to any one of the above items, wherein the method is ISO. In accordance with the 11676 standard, on a knitting machine with two guide bars B1 and B2, the following pattern: -bar B1: 1.2 / 4.5 / 4.3 / 4.5 / 4.3 / 1.0 / 1.2 / 1.0 //-bar B2: 4.3 / 1.0 / A method involving the step of making a knit with a monofilament of a biocompatible polymeric material according to 1.2 / 1.0 / 1.2 / 4.5 / 4.3 / 4.5 //. (Item 10) The method according to any one of the above items, wherein the guide bars B1 and B2 are pierced by 1 full 1 empty and move symmetrically. (Item 11) A hernia prosthesis containing the porous knit for the prosthesis according to any one of the above items.</p><p> (Summary) The present invention relates to a porous knit for a prosthesis based on a monofilament of a biocompatible polymer material, the pattern followed for knitting the monofilament in a knitting machine having two guide bars B1 and B2 is ISO. According to the 11676 standard: -Bar B1: 1.2 / 4.5 / 4.3 / 4.5 / 4.3 / 1.0 / 1.2 / 1.0 //-Bar B2: 4.3 / 1.0 / 1.2 / 1.0 / 1.2 / 4.5 / 4.3 / 4.5 // ..</p><p> The present invention further relates to methods for producing such knits, and hernia prostheses containing such knits.</p>

<figref num="1">FIG. 1 is a schematic view of a knit knitting pattern of the present invention.</figref><figref num="2">FIG. 2 is a front view of the knit of the present invention obtained by using the knitting pattern of FIG.</figref><figref num="3">FIG. 3 is a side view of a schematic configuration of a system for measuring the distribution of shear forces at a fixed point of a knit.</figref><figref num="4">FIG. 4 is an enlarged perspective view of a portion of the system of FIG.</figref>

Referring to FIG. 1, according to the ISO 11676 standard, the knit knitting pattern of the present invention, namely the following patterns: -bar B1: 1.2 / 4.5 / 4.3 / 4.5 / 4.3 / 1.0 / 1.2 / 1.0 //-bar B2: Illustrations showing 4.3 / 1.0 / 1.2 / 1.0 / 1.2 / 4.5 / 4.3 / 4.5 // are shown.

The overall pattern repeat size of the knit of the present invention is 8 courses. Figure 1 shows only one thread from guide bar B1 and one thread from guide bar B2 to better show the movement of threads. The thread progress in the 9th course is the same as in the 1st course.

With reference to FIG. 2, a photograph of the knit 1 of the present invention obtained using the knitting pattern as shown in FIG. 1 is shown.

Knit 1 in FIG. 2 was obtained from a polypropylene monofilament with a diameter of 0.12 mm.

The knit knitting pattern of the present invention creates holes larger than about 1.0 mm in diameter. For example, the main hole 2 of the knit 1 of FIG. 2 has an average size of 2.0 x 2.4 mm. Such a large size of the pores is very favorable for cell colonization, giving the knit good fluoroscopy and allowing good visibility at the implantation site.

The knit of the present invention exhibits a uniform distribution of shear forces at fixed points. Shear force distribution at fixed points is an axisymmetric experimental system for assessing shear force distribution at fixed points in textile-based implants (eg, as described with reference to FIGS. 3 and 4). Can be evaluated using a device), such a system makes it possible to demonstrate the ability of a textile to distribute shear forces at a fixed point without integrating specific geometric considerations.

Next, referring to FIGS. 3 and 4, the system 10 is fixed to the organization model 100, the load simulation device 200, and the organization model 100, and is textile-based when subjected to the load exerted by the load simulation device 200. Includes an analysis system 300 for assessing the characteristics of the implant 400. The tissue model 100 includes a base 110, which has an upper surface 112 extending along a plane "P" and a closed outer circumference 114, through which the base 110 passes. Defines the opening 116. The upper surface 112 is configured to mimic the inner surface of the abdominal wall: it is flat and horizontal. The opening 116 defined through the upper surface 112 is configured to mimic a defect in the abdominal wall and may be referred to herein as a "defect". The opening 116 has a circular shape as well as a uniform size and dimensions throughout the height "H" of the base 110. In the system of FIG. 3, opening 116 is an empty circle with a radius of 55 mm with a fillet of 10 mm.

The upper surface 112 is covered with a coating 112a having a coefficient of friction that mimics the coefficient of friction of the inner surface abdominal wall with respect to the textile-based implant 400. The coefficient of friction is about 0.3.

The base 110 includes a lower plane surface 118, which is lowered from the upper plane surface 112 at a predetermined height "H1" and extends around the upper surface 112.

The base 110 also includes a fixed support in the form of a plurality of rods 120, which fixed support is configured to secure the textile-based implant 400 to the base 110 at two or more fixation points. .. The plurality of rods 120 are attached to the lower surface 118 at a predetermined distance "D1" of 20 mm from each other and at a predetermined distance "D2" of 70 mm from the end of the upper surface 112. The rod 120 is arranged with a simple circular crown fixation and is centered with respect to the opening 116. Each rod 120 has a first end 120a fixed to the lower surface 118, an elongated body 120b extending from the lower surface 118 toward the upper surface 112 and defining a length "L" of 60 mm, and an upper surface 112. Includes a second end 120c terminating near or above the plane "P" as defined by. The elongated member 120b extends vertically from the lower surface 118. Rod 120 is a threaded rod M3 with an equivalent radius of 2.5 mm and Young's modulus of 110 Gpa.

The rod 120 is directly secured to a portion of the textile-based implant 400 when the textile-based implant 400 is placed on the upper surface 112 of the tissue model 100 over an opening 116 in the upper surface 112. Is configured for. The pull at the fixed point in the textile-based implant 400 is minimal. The marker 122 is attached to the second end 120c of the rod 120 so that the marker 122 is located near or above the surface "P" defined by the upper surface 112. Each marker 122 is in the form of a white circle with a diameter of 5 mm within a black circle with a diameter of 10 mm and is located 8 mm above the textile-based implant 400. The marker 122 provides a visual indication of the position of the rod 120. Markers 122 are distributed above the ends of the two warp threads in the middle of the textile-based implant 400.

The load simulation device 200 is positioned above the upper surface 112 of the base 110 and simulates changes in the environmental load conditions surrounding the tissue model 100 so that changes in the load for the tissue model 100 are generated. It is configured to be a model. The load may be referred to herein as the "abdominal pressure equivalent". As shown, the load simulation device 200 is a plunger 210 that includes a contact surface 212, which is a hemisphere (100 mm in diameter) centered over an opening 116 defined through the upper surface 112. Has been done. The plunger 210 is configured to move in a direction perpendicular to the plane "P" of the upper surface 112 and exert a predetermined force, hereinafter referred to as the plunger force, on the textile-based implant 400. As a result, the implant 400 engages the opening 116 defined within the upper surface 112 of the tissue model 100. The load simulation device 200 can apply quasi-static pressure (low plunger 210 descent rate) to the textile-based implant 400 to simulate various physiological conditions. For example, the plunger force applied can be 147N, or 116mmHg, which corresponds to the intraabdominal pressure when the patient is in a standing Valsalva state. Alternatively, the plunger force applied can be 304N, or 240mmHg, which corresponds to the intraabdominal pressure when the patient jumps.

The analysis system 300 loads the digital image acquisition and processing component 310, which includes two cameras 312 to record the position of the marker 122 in the 3D coordinate system, and the load exerted by the load simulation device 200 on the textile-based implant 400. In response, digital image correlation software 314 for calculating the displacement vector of each of the markers 122 resulting from the flexion of the rod 120, namely Vic 3D from Correlated Solutions.^TMAnd include. The analysis system 300 records the plunger displacement 210. The analysis system 300 also includes a mathematical software component 320, which uses the displacement vector component at the plane "P" of the marker 122 and the continuum mechanics logic applied to the rod 120. It is used to calculate the shear force vector at each fixed point where the marker 122 is present. Therefore, each shear force vector is a function of the "abdominal pressure equivalent". Mathematical software component 320 may include any numerical software package (eg, MATLAB® from Matchworks).

Signs for the bulge of the textile-based implant 400 through the opening 116 can be given by an assessment of the penetration of the plunger through the opening 116.

In an exemplary use, the textile-based implant 400 (eg, a prosthesis knit) is the base of the tissue model 100 such that the implant 400 is placed along the plane "P" defined by the upper surface 112. It is installed on the upper surface 112 of 110. The implant 400 is placed and centered around the opening 116 in the upper surface 112, and as will be appreciated by those skilled in the art, the fiber orientation of the implant 400 is relative to the upper surface 112. It is controlled. The textile-based implant 400 is then fixed directly to the plurality of fixing rods 120. A plurality of markers 122 are then attached to a portion of the fixation rod 120 such that the markers 122 extend between the ends of the two warp threads of the implant 400.

With the implant 400 fixed to the tissue model 100, the analysis system 300 is operated so that the camera 312 captures the position of the marker 122 in the 3D coordinate system. Acquisition of the position / position change of the marker 122 through the camera 312 is such that the force applied to the implant 400 by the load simulation device 200 is transmitted to the rod 120 at the fixed point, resulting in the flexion of the rod 120. , Synchronized with the operation of the load simulation device 200. Thus, as described above, any movement of the rod 120 results in the movement of the marker 122, which movement is recorded by the camera 312 and used in determining the shear force vector at each fixed point. ..

As will be apparent from the examples below, the systems of FIGS. 3 and 4 make it possible to assess the properties of the prosthesis knit with respect to shear force distribution at fixed points, bulging phenomena, and breakage at fixed points. To do.

The advantages of the knits of the present invention will become more apparent in the examples below.

<p> Example: Two lightweight knits of the prior art (knits A and B) and a knit of the present invention (knit C) were produced as described below.</p><p> Knit A: Knit A is a prior art knit as described in WO 2011/042811, i.e., in a warp knitting machine with two guide bars B1, B2 according to ISO 11676 standard, the following pattern: -Bar B1: 1.0 / 1.2 / 1.0 / 2.3 / 2.1 / 2.3 / 4.5 / 4.3 / 4.5 / 3.2 / 3.4 / 3.2 //-Bar B2: 4.5 / 4.3 / 4.5 / 3.2 / 3.4 / 3.2 / 1.0 / 1.2 / 1.0 It is a knit obtained by knitting a monofilament of polyethylene terephthalate having a diameter of 0.08 mm according to /2.3/2.1/2.3//.</p><p> Guide bars B1 and B2 are pierced with 1 full 1 empty and move symmetrically.</p><p> Knit B: Knit B is a prior art knit as described in US Pat. No. 6,408,656, i.e., in a warp knitting machine with two guide bars B1, B2, in accordance with ISO 11676 standards, the following pattern: : -Bar B1: 5.4 / 4.3 / 2.1 / 0.1 / 1.2 / 3.4 //-Bar B2: 0.1 / 1.2 / 3.4 / 5.4 / 4.3 / 2.1 // Obtained by knitting a polypropylene monofilament with a diameter of 0.10 mm It is a knit that can be used.</p><p> Guide bars B1 and B2 are pierced with 1 full 1 empty and move symmetrically.</p><p> Knit C: This is the knit of the present invention obtained by knitting a polypropylene monofilament with a diameter of 0.12 mm in the knitting pattern of FIG. 1, knitted in a warp knitting machine having two guide bars B1 and B2. The patterns to be followed are as follows: -Bar B1: 1.2 / 4.5 / 4.3 / 4.5 / 4.3 / 1.0 / 1.2 / 1.0 //-Bar B2: 4.3 / 1.0 / 1.2 / 1.0 / 1.2 / 4.5 / 4.3 /4.5//.</p><p> Guide bars B1 and B2 are pierced with 1 full 1 empty and move symmetrically.</p><p> The following properties of knits A, B, and C were determined as follows: -Mass per unit area (g / m)²): Measured according to ISO 3801: 1977 "Determining mass per unit length and mass per unit area" (5 samples, 1 dm)²),-Hole size (width x height) (mm): Measure the largest hole in the knit with a profile projector (eg, projector 300V from ORAMA) and make one measurement for each of the 10 individual samples. , -Rupture strength (kPa): ISO 13938-2: 1999 Measured according to "Textiles-Rupture properties of textiles-Pneumatic methods for determining burst strength and burst deformation" (5 samples),-Tensile strength (N) / cm) is measured through a plunger test using a traction tester (eg, Hounsfield model H5KS (Hounsfield, Redhill, England)) (crosshead speed: 50 mm / min, 5 samples): burst pressure, R_m= 100 cm with a radius of 56.4 mm and clamped at the outer border (boarder)²Can be determined using a circular mesh sample with the test area of (modified DIN 54307 new standard). Then, on the mesh, radius R until tearing occurs_sLoad with a spherical stamp of = 50mm, speed v = 50mm / min. Tensile strength (N / cm) can be calculated based on the measured force and the resulting stretch; -Tensile strength in the warp direction (N) and tear strength in the weft direction (N): ISO 4674: 1977 "Textile covered with rubber or plastic-Determining the tear strength" Measured according to method A2 (5 samples, width: 75mm, tear length 145mm, crosshead speed: 100mm / min), -Thickness: ISO 9073-2: 1997 Measured according to "Textiles-Testing Methods for Nonwovens-Part 2: Determining Thickness" (10) Sample, 100 x 50 mm), -Tensile breaking strength and elongation at break: ISO 13934-1: 2013 "Tensile properties of fabrics-Part 1: Determination of maximum force using strip method and elongation at maximum force" Measured using a traction tester (eg, Hounsfield model H5KS (Hounsfield, Redhill, England)) (5 samples, width: 50 mm, length: intermaxillary 200 mm, crosshead speed: 100 mm / min, reserve load : 0.5N), -Effective porosity: Measure holes with diameters greater than 1 mm with a profile projector (eg, projector 300V from ORAMA) (1 sample of 100 x 50 mm);-Suture pull-out strength in the warp and weft directions Using a traction tester (eg, Hounsfield model H5KS (Hounsfield, Redhill, England)), NF S94-801: 2007 "Treatment of stress urinary incontinence and / or treatment of pelvic organ prolapse. Reinforced implants introduced by the vaginal route for-preclinical and clinical studies "-measured according to §5.3.3 (5 specimens, 50 x 100 mm, USP 2 suture yarn, crosshead speed: 100 mm / min).</p><p> The results are collected in the table below.</p><p><tables num="1"><img file="JP6637745B2_D0001.tif" /></tables></p><p><tables num="2"><img file="JP6637745B2_D0002.tif" /></tables></p><p> With reference to Table I above, the knits of the present invention (knits C) show improved mechanical properties as compared to the prior art knits (knits A and B). In particular, the knit of the present invention exhibits higher tensile breaking strength than knits A and B in both the warp and weft directions. The knit of the present invention exhibits higher burst strength than knits A and B. The knit of the present invention exhibits higher tear strength than knits A and B in both the warp and weft directions.</p><p> The knits of the present invention (knits C) show improved pull-out strength in both the warp and weft directions as compared to the prior art knits (knits A and B). The knit of the present invention exhibits higher tensile strength than knits A and B in both the warp and weft directions.</p><p> With reference to Table II above, the knits of the present invention further show improved effective porosity compared to knits A and B.</p><p> In addition, the systems described in FIGS. 3 and 4 were utilized to evaluate the following properties of knits A, B, and C under various simulated physiological conditions. To undertake these measurements, the textile-based implant 400 of FIGS. 3 and 4 is replaced with a knit sample of knit A, B, or C to be evaluated.</p><p> The following properties were evaluated: 1 °) Shear force distribution at the fixed point of the knit Profile: For each plunger force (ie 147N, 304N, respectively), marker displacement as described above, software from Matchworks. The mechanical continuum logic applied to the rod, implemented in MATLAB®, is used to convert from the initial fixation position to the shear force at each fixation point where the marker is present. Record the shear force vector. Record the maximum and minimum vector norm values. The average distribution of shear forces at a fixed point has the following form:</p><p><chemistry num="1"><img file="JP6637745B2_D0003.tif" /></chemistry></p><p>Can be obtained at.</p><p> Shear force distribution can be outlined by the graphic profile below.</p><p><chemistry num="2"><img file="JP6637745B2_D0004.tif" /></chemistry></p><p> Determine the average force minimum-maximum (N): In the example profile above, the average force minimum-maximum (N) at a plunger force of 147N is 3.8-8, at a plunger force of 304N. The average force minimum-max (N) is 7.1-13.5.</p><p> For knits, the risk of knit damage is reduced when the average force minimum-maximum value range is low. Knits and therefore abdominal wall repairs are more effective.</p><p> Moreover, the closer the shear force profile is to a semicircle or semicircle, the more regularly the shear force is distributed. Therefore, the risk of pulling in a particular direction is reduced. Moreover, since the forces are of similar value in all directions, the knit can be transplanted without having to look at a particular position in the warp or weft direction of the knit. Knits, or prostheses made from knits, are also more comfortable for the patient.</p><p> 2 °) Signs of bulge: Plunger 210 as shown in FIGS. 3 and 4 from the initial position where the contact surface 212 of the plunger 210 is in contact with the sample knit to the final position obtained after applying the plunger force. Corresponds to the penetration distance (in mm) of.</p><p> Signs of too high a bulge, for example above 50 mm at a plunger force of 304 N, or above 45 mm at a plunger force of 147 N, for the knit / prosthesis to ensure its reinforcing function on the abdominal wall. It can mean that it can be too soft and / or that the knit / prosthesis can create discomfort and / or aesthetic interference.</p><p> 3 °) Knit tear at fixation: Record the number of tears at the fixation point.</p><p> The results are collected in the table below.</p><p><tables num="3"><img file="JP6637745B2_D0005.tif" /></tables></p><p> As is clear from the table above, the knit (knit C) of the present invention shows a regular contour profile very close to a semicircle. Therefore, the shear forces are regularly distributed. Thus, the knit of the invention can be introduced and implanted at the site of implantation without the need for the surgeon to preliminarily examine the particular positioning of the warp or weft orientation of the knit.</p><p> Furthermore, the number of breaks at the fixed point is 0 for the knits of the present invention, while it is 2 for the prior art knits (knits A and B). Therefore, the knits of the present invention are more reliable than prior art knits when sewn or attached to surrounding biological tissue.</p><p> With respect to signs of bulge, the knits of the present invention (knit C) show better signs of bulge than prior art knits in both plunger forces. Therefore, the knits of the present invention ensure their reinforcing function of the abdominal wall and are more effective than prior art knits in physiological conditions (eg, jumping or coughing).</p>