Abstract:
The invention relates to a prosthetic porous knit based on a monofilament of a biocompatible polymer material, the pattern followed for the knitting of said monofilament on a warp knitting machine having two guide bars B 1,  B 2  being the following, according to the ISO 11676 standard:
       Bar B 1:  1.2/4.5/4.3/4.5/4.3/1.0/1.2/1.0//   Bar B 2:  4.3/1.0/1.2/1.0/1.2/4.5/4.3/4.5//       
 
     The invention further relates to a method for producing such a knit and to a hernia prosthesis comprising such a knit.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims benefit of and priority to European Patent Application Serial No. 14306956.5 filed Dec. 5, 2014, the disclosure of the above-identified application is hereby incorporated by reference in its entirety. 
       TECHNICAL FIELD 
       [0002]    The present invention relates to a prosthetic porous knit useful in parietal surgery, the knit having a lightweight and macroporous structure while showing good mechanical strength properties. 
       BACKGROUND 
       [0003]    Wall-reinforcing prostheses, for example 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 a tissue defect. These prostheses are generally made of biocompatible prosthetic fabric, in particular prosthetic knits, and can have a number of shapes, for example rectangular, circular or oval, depending on the anatomical structure to which they are to be fitted. 
         [0004]    In a view of reducing the foreign material implanted into the body of a patient, it is desired to produce lightweight knits, intended to be used as wall reinforcing prostheses. In addition, for facilitating the work of the surgeon at the time he puts the prosthesis in place at the implantation site, it is further desired that the prosthetic knit show a good transparency. Moreover, the wall reinforcing prosthesis should also favor a good tissue ingrowth. In this view, it is desired that the knit used for wall reinforcing prostheses show a plurality of pores, and preferably large pores. 
         [0005]    Lightweight porous knits usable in the manufacture of wall reinforcing prostheses already exist. Nevertheless, they sometimes show poor mechanical strength. Indeed, the knit is generally pliant and soft in order to conform to the abdominal wall and flex with movement of the abdominal wall once implanted. The knit may be held in place by suturing, stapling, or tacking the knit to surrounding biological tissue. In particular, existing lightweight porous knits may show a poor resistance to fracture when they are sutured or tacked to the surrounding biological tissue. 
         [0006]    In addition, the performance of the abdominal wall hernia repair using a prosthetic knit fixed on the abdominal wall depends in part upon the shear forces experienced at the knit fixation points. These shear forces may be quite high as a result of high intra-abdominal pressure. 
         [0007]    Too high shear forces at knit fixation points, once the knit or prosthesis is implanted and has been fixed for example by sutures at the abdominal wall, may lead to abdominal wall repair recurrences and/or generate pain for the patient. The distribution of shear forces at fixation points is important to assess the safety and the efficacy of the abdominal wall repair. 
       SUMMARY 
       [0008]    In particular, it would be desirable to provide a prosthesis made from a knit for which the distribution of the shear forces at fixation points is as regular as possible and for which the value of shear forces at fixation points is as low as possible, so that the prosthesis may for example be introduced at the implantation site and implanted without the surgeon having to check for a specific position of the warp or weft direction of the knit. It would further be desirable to provide a prosthesis made from a knit for which the risk of fixation pull out and/or implant failure at fixation points is reduced. 
         [0009]    In addition, if a knit is too pliant and soft, it may not resist sufficiently to the intra abdominal pressure during specific movements of the patient, for example when the patient coughs or jumps. The knit may then be prone to undesired bulging phenomenon and may not ensure sufficient reinforcement of the abdominal wall in such conditions. 
         [0010]    There is therefore a need for a porous prosthetic knit that would be capable of having a lightweight and macroporous structure while at the same time show good mechanical strength properties. 
         [0011]    A first aspect of the invention is a prosthetic porous knit based on a monofilament of a biocompatible polymer material, the pattern followed for the knitting of said monofilament on a knitting machine having two guide bars B 1 , B 2  being the following, according to the ISO 11676 standard:
       Bar B 1 : 1.2/4.5/4.3/4.5/4.3/1.0/1.2/1.0//   Bar B 2 : 4.3/1.0/1.2/1.0/1.2/4.5/4.3/4.5//       
 
         [0014]    Another aspect of the invention is a method for manufacturing the prosthetic knit above comprising the step of producing a knit with a monofilament of a biocompatible polymer material on a knitting machine having two guide bars B 1 , B 2  according to the following pattern, according to the ISO 11676 standard:
       Bar B 1 : 1.2/4.5/4.3/4.5/4.3/1.0/1.2/1.0//   Bar B 2 : 4.3/1.0/1.2/1.0/1.2/4.5/4.3/4.5//       
 
         [0017]    Guide bars B 1  and B 2  may be threaded 1 full 1 empty and may move symmetrically. 
         [0018]    The knitting machine may be a warp knitting machine or a raschel knitting machine. 
         [0019]    The knit of the invention is porous. In particular, the knit of the invention comprises openings or pores: these openings or pores are in particular generated by the pattern followed for the knitting of the monofilament of the knit according to the invention. The porosity of the knit of the invention confers to the knit a transparency allowing the surgeon to have a good visibility of the implantation site at the time he puts the knit or prosthesis in place. 
         [0020]    The knit of the invention is lightweight. The knit of the invention preferably shows a mass per unit area ranging from about 40 to about 70 g/m 2 , preferably ranging from about 40 to about 50 g/m 2 , and more preferably of about 44 g/m 2 , 45 g/m 2 , 46 g/m 2 , 47 g/m 2  or 48 g/m 2 , measured according to ISO 3801: 1977 &lt;&lt;Determination of mass per unit length and mass per unit area&gt;&gt;, 5 specimens 1 dm 2 . Such a low mass per unit area allows introducing only a little quantity of foreign material in the body of the patient. 
         [0021]    The knit of the invention is made from a monofilament of biocompatible polymer material. 
         [0022]    The biocompatible polymer may be synthetic or natural. The biocompatible polymer may 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 bioresorbable materials. By biodegradable, it is meant that the materials decompose, or lose structural integrity under body conditions (e.g., enzymatic degradation or hydrolysis) or are broken down (physically or chemically) under physiologic conditions in the body such that the degradation products are excretable or absorbable by the body. 
         [0023]    The biocompatible polymer may be selected from the group consisting of biodegradable polymers, non-biodegradable polymers, and combinations thereof. 
         [0024]    In embodiments, the biocompatible polymer material is selected from polypropylene, polyester such as polyethylene terephthalates, polyamide, silicone, polyether ether ketone (PEEK), polyarylether ether ketone (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. 
         [0025]    In embodiments, the biocompatible polymer material is polypropylene. 
         [0026]    In embodiments, the monofilament has a diameter of from about 0.08 mm to about 0.25 mm, preferably from about 0.10 mm to 0.15 mm, more preferably of about 0.11 mm, 0.12 mm, or 0.13 mm. Such a diameter allows obtaining a good size of the pores and maintaining the lightweight structure of the knit, while maintaining good mechanical properties. In embodiments, the monofilament has a diameter of about 0.12 mm. 
         [0027]    In embodiments, the knit comprises a plurality of pores having a diameter above 1 mm. In particular, the plurality of pores having a diameter above 1 mm defines an efficient porosity of said knit ranging from about 35% to about 70%, preferably of about 55%. 
         [0028]    By “efficient porosity” is meant according to the present application a porosity taking into account only the pores having a diameter above 1 mm, while leaving out the pores having a diameter less or equal to 1 mm. By “pores having a diameter above 1 mm” is meant the pores which have dimensions greater than 1 mm in all directions. The efficient porosity therefore corresponds to the ratio of the area of the totality of the pores having a diameter above 1 mm as defined above to the area of the totality of the knit studied. The pores having a diameter above 1 mm are measured with a profile projector such as a projector 300V from ORAMA. The “efficient porosity” and its measuring method are described in the publication “ New objective measurements to characterize the porosity of textile implants”,  T. Mühl, M. Binnebösel, U. Klinge and T. Goedderz, Journal of Biomedical Materials Research Part B: Applied Biomaterials, p. 176-183. 
         [0029]    The efficient porosity as described above is useful for characterizing the ability of the knit to favor cell colonization. Indeed, pores having a diameter above 1 mm are particularly desired for tissue ingrowth after implantation. 
         [0030]    The knitting pattern of the knit of the invention defines a plurality of pores having a diameter ranging above 1 mm. The pores may have a substantially hexagonal or circular shape. 
         [0031]    In embodiments, the knit of the invention comprises a plurality of pores having a diameter above 2 mm. Such knits with pores having a diameter above 2 mm favor cell colonization and exhibit a good transparency allowing the surgeon to have a better visibility of the surrounding tissues when he puts the knit/prosthesis in place at the implantation site. 
         [0032]    In embodiments, the knit of the invention has a tensile breaking strength in the warp direction of at least about 200 N, preferably of about 237 N. In embodiments, the knit of the invention has a tensile breaking strength in the weft direction of at least about 170 N, preferably of about 201 N. In embodiments, the knit of the invention has a bursting strength of at least about 400 kPa, preferably of about 463 kPa. In embodiments, the knit of the invention has a tear strength in the warp direction of at least about 25 N, preferably of about 30 N. In embodiments, the knit of the invention has a tear strength in the weft direction of at least about 25 N, preferably of about 37 N. In embodiments, the knit of the invention has a suture pull out strength in the warp direction of at least about 35 N, preferably of about 46 N. In embodiments, the knit of the invention has a suture pull out strength in the weft direction of at least about 38 N, preferably of about 42 N. In embodiments, the knit of the invention has a tensile strength of at least about 42 N/cm, preferably of about 47 N/cm. 
         [0033]    The tensile breaking strength (N), the bursting strength (kPa), the tear strength (N), the suture pull out strength (N) and the tensile strength (N/cm) above are measured according to the methods as indicated in the below Example of the present application. 
         [0034]    Following knitting and heat-setting, the knit can be cleaned, packaged and sterilized using conventionally known techniques. The knit of the invention can be used as provided in the package or cut to any desired dimension once removed from the package. 
         [0035]    The knit of the invention can be implanted in extraperitoneal site either for inguinal or ventral hernia repair via open or laparoscopic approach. Fixation to the surrounding tissues can be achieved by stapling, conventional sutures or other means. 
         [0036]    The prosthetic knit of the invention shows an homogeneous distribution of shear forces at fixation points. In particular, although it is provided with a lightweight structure, the prosthetic knit of the invention shows a good resistance to fracture at fixation points compared to lightweight knits of the prior art. 
         [0037]    The knit of the invention may be used on its own as a prosthesis to be implanted into in a patient for hernia repair for example. 
         [0038]    Another aspect of the invention is a hernia prosthesis comprising a knit as described above. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0039]    The present invention will become clearer from the following description and from the attached drawings, in which: 
           [0040]      FIG. 1  is a schematic view of the knitting pattern of a knit of the invention, 
           [0041]      FIG. 2  is a front view of the knit of the invention obtained with the knitting pattern of  FIG. 1 , 
           [0042]      FIG. 3  is a side view of a schematic configuration of a system for measuring the distribution of the shear forces at fixation points of a knit, 
           [0043]      FIG. 4  is an enlarged perspective view of a portion of the system of  FIG. 3 . 
       
    
    
     DETAILED DESCRIPTION 
       [0044]    With reference to  FIG. 1 , is shown a graphic representing the knitting pattern of the knit of the invention, namely the following pattern according to the ISO 11676 standard:
       Bar B 1 : 1.2/4.5/4.3/4.5/4.3/1.0/1.2/1.0//   Bar B 2 : 4.3/1.0/1.2/1.0/1.2/4.5/4.3/4.5//       
 
         [0047]    The overall pattern repetition size of the knit of the invention is eight courses.  FIG. 1  depicts only one thread from guide bar B 1  and one thread from guide bar B 2  to better show the movement of the thread. The evolution of the threads at the ninth course is the same as at the first course. 
         [0048]    With reference to  FIG. 2 , is shown a photograph of the knit  1  of the invention obtained with the knitting pattern as represented in  FIG. 1 . 
         [0049]    The knit  1  of  FIG. 2  was obtained from a monofilament of polypropylene of diameter 0.12 mm. 
         [0050]    The knitting pattern of the knit of the invention produces pores greater than about 1.0 mm in diameter. For example, the principal pores  2  of the knit  1  of  FIG. 2  have an average size of 2.0×2.4 mm. Such a large size of pores is very favorable for cell colonization and confers to the knit a good transparency allowing a good visibility at the implantation site. 
         [0051]    The knit of the invention shows an homogeneous distribution of the shear forces at fixation points. The distribution of the shear forces at fixation points may be evaluated with a system for assessing shear forces distribution at fixation points of textile-based implants, such as an axisymmetrical experimental set-up as described in reference to  FIGS. 3 and 4 , such a system allowing exhibiting the capability of a textile to distribute shear forces at fixation points without integrating specific geometrical considerations. 
         [0052]    Referring now to  FIGS. 3 and 4 , system  10  includes a tissue model  100 , a load simulation device  200 , and an analysis system  300  for assessing characteristics of a textile-based implant  400  when fixed to the tissue model  100  and subjected to a load exerted by the load simulation device  200 . The tissue model  100  includes a base  110  having an upper surface  112  extending along a plane “P” and having a closed outer perimeter  114  that defines an opening  116  therethrough. The upper surface  112  is configured to mimic the inner surface of an abdominal wall: it is flat and horizontal. The opening  116  defined through the upper surface  112  is configured to mimic a defect in an abdominal wall and may be referred to herein as the “defect”. The opening  116  has a circular shape and a uniform size and dimension through the height “H” of the base  110 . In the system of  FIG. 3 , the opening  116  is an empty circle having a radius of 55 mm with a 10 mm fillet. 
         [0053]    The upper surface  112  is covered by a coating  112   a  having a coefficient of friction that mimics the frictional coefficient of an inner surface abdominal wall against a textile-based implant  400 . The coefficient of friction is about 0.3. 
         [0054]    The base  110  includes a lower planar surface  118  that is stepped down from the upper planar surface  112  at a pre-determined height “H 1 ” and extends around the upper surface  112 . 
         [0055]    The base  110  also includes a fixation support under the form of a plurality of rods  120 , configured to secure a textile-based implant  400  thereto at two or more fixation points. The plurality of rods  120  are attached to the lower surface  118  at a predetermined distance “D 1 ” of 20 mm from each other and a predetermined distance “D 2 ” of 70 mm from the upper surface  112  extremity. The rods  120  are arranged in a simple circle crown fixation, centered to the opening  116 . Each rod  120  includes a first end  120   a  fixed to the lower surface  118 , an elongate body  120   b  extending from the lower surface  118  towards the upper surface  112  and defining a length “L” of 60 mm, and a second end  120   c  terminating about or above the plane “P” defined by the upper surface  112 . The elongate body  120   b  extends perpendicularly from the lower surface  118 . The rods  120  are threaded rod M 3 , with an equivalent radius of 2.5 mm and a Young Modulus of 110 Gpa. 
         [0056]    The rods  120  are configured for direct fixation to a portion of the textile-based implant  400  when the textile-based implant  400  is placed upon the upper surface  112  of the tissue model  100  over the opening  116  in the upper surface  112 . The tension at the fixation points in the textile-based implant  400  is minimum. Markers  122  are attached to the second end  120   c  of the rods  120  such that the markers  122  are disposed about or above the plane “P” defined by the upper surface  112 . Each marker  122  is under the form of a white circle of diameter 5 mm within a black circle of diameter of 10 mm and is localized 8 mm above the textile-based implant  400 . Markers  122  provide a visual indication of the position of the rods  120 . Markers  122  are distributed on half of the textile-based implant  400  from two warp extremities. 
         [0057]    The load simulation device  200  is positioned above the upper surface  112  of the base  110  and is configured to simulate a change in environmental loading conditions surrounding the tissue model  100  such that changes in load are generated about the tissue model  100 . The load may be referred to herein as the “intra abdominal pressure equivalent.” As shown, the load simulation device  200  is a plunger  210  including a contacting surface  212  that is hemispherical (diameter 100 mm) and that is centered over the opening  116  defined through the upper surface  112 . 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, referred to hereinafter as the plunger force, against the textile-based implant  400  so that the implant  400  engages the opening  116  defined within the upper surface  112  of the tissue model  100 . The load simulation device  200  is capable of applying a quasi-static pressure (low plunger  210  descent velocity) on the textile-based implant  400  to simulate various physiological conditions. For example, the plunger force applied may be of 147 N, namely 116 mmHg, which corresponds to the intra abdominal pressure when the patient is in a standing valsalva condition. Alternatively, the plunger force applied may be of 304 N, namely 240 mmHg, which corresponds to the intra abdominal pressure when the patient jumps. 
         [0058]    The analysis system  300  includes a digital image acquisition and processing component  310  including two cameras  312  for recording the position of the markers  122  in a 3D coordinate system and digital image correlation software  314 , namely Vic 3D™ from the company Correlated Solutions for calculating the displacement vector of each of the markers  122  resulting from bending of the rods  120  in response to the loads exerted on the textile-based implant  400  by the load simulation device  200 . The analysis system  300  records the plunger displacement  210 . The analysis system  300  also includes a mathematical software component  320  that is utilized to calculate the shear force vector at each fixation point where a marker  122  exists using the displacement vector component in the plane “P” of the markers  122  and the continuum mechanics theory applied to the rods  120 . Accordingly, each shear force vector is a function of the “intra abdominal pressure equivalent.” The mathematical software component  320  may include any numerical software package, such as, for example, MATLAB® from the company Matchworks. 
         [0059]    An indication on the bulging of the textile-based implant  400  through the opening  116  may be given by the assessment of the plunger penetration through the opening  116 . 
         [0060]    In an exemplary method of use, a textile-based implant  400 , such as a prosthetic knit, is placed on the upper surface  112  of the base  110  of the tissue model  100  such that the implant  400  lies along the plane “P” defined by the upper surface  112 . The implant  400  is centered placed about the opening  116  in the upper surface  112  and, as should be understood by a person of ordinary skill in the art, the orientation of the fibers of the implant  400  is controlled with respect to the upper surface  112 . The textile-based implant  400  is then directly fixed to the plurality of fixation rods  120 . A plurality of markers  122  are then affixed to a portion of the fixation rods  120  such that the markers  122  extend between the two warp extremities of the implant  400 . 
         [0061]    With the implant  400  fixed to the tissue model  100 , the analysis system  300  is activated such that the cameras  312  capture the position of the markers  122  in a 3D coordinate system. The acquisition of the position/positional changes of the markers  122  via the cameras  312  is synchronized with the activation of the load simulation device  200  as the forces applied to the implant  400  by the load simulation device  200  is transferred to the rods  120  at the fixation points and results in bending of the rods  120 . Accordingly, any movement of the rods  120  results in movement of the markers  122  which is recorded by the cameras  312  and used in determining the shear force vector at each fixation point as described above. 
         [0062]    As will appear from the Example below, the system of  FIGS. 3 and 4  allows evaluating the properties of prosthetic knits regarding the distribution of shear forces at fixation points, bulging phenomenon and fracture at fixation points. 
         [0063]    The advantages of the knit of the invention will appear more clearly in the Example below. 
       EXAMPLE 
       [0064]    Two lightweight knits of the prior art (Knits A and B) and a knit of the invention (knit C) have been produced as described below. 
         [0065]    Knit A: knit A is a knit of the prior art as described in WO2011/042811, namely obtained by knitting a monofilament of polyethylene terephthalate of diameter 0.08 mm on a warp knitting machine having two guide bars B 1 , B 2 , according to the following pattern, according to the ISO 11676 standard:
       Bar B 1 : 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 B 2 : 4.5/4.3/4.5/3.2/3.4/3.2/1.0/1.2/1.0/2.3/2.1/2.3//       
 
         [0068]    Guide bars B 1  and B 2  are threaded 1 full 1 empty and move symmetrically. 
         [0069]    Knit B: knit B is a knit of the prior art as described in U.S. Pat. No. 6,408,656, namely obtained by knitting a monofilament of polypropylene of diameter 0.10 mm on a warp knitting machine having two guide bars B 1 , B 2 , according to the following pattern, according to the ISO 11676 standard:
       Bar B 1 : 5.4/4.3/2.1/0.1/1.2/3.4//   Bar B 2 : 0.1/1.2/3.4/5.4/4.3/2.1//       
 
         [0072]    Guide bars B 1  and B 2  are threaded 1 full 1 empty and move symmetrically. 
         [0073]    Knit C: is a knit of the invention obtained with the knitting pattern of  FIG. 1 , by knitting a monofilament of polypropylene of diameter 0.12 mm knitted on a warp knitting machine having two guide bars B 1 , B 2 , the pattern followed being the following, according to the ISO 11676 standard:
       Bar B 1 : 1.2/4.5/4.3/4.5/4.3/1.0/1.2/1.0//   Bar B 2 : 4.3/1.0/1.2/1.0/1.2/4.5/4.3/4.5//       
 
         [0076]    Guide bars B 1  and B 2  are threaded 1 full 1 empty and move symmetrically. 
         [0077]    The following properties of knits A, B and C have been determined as follows: 
         [0078]    Mass per unit area (g/m 2 ): measured according to ISO 3801: 1977 &lt;&lt;Determination of mass per unit length and mass per unit area&gt;&gt;, 5 specimens 1 dm 2 , 
         [0079]    pore size (width×height) (mm): knit biggest pores are measured making one measurement on 10 individual samples with a profile projector such as a projector 300V from ORAMA, 
         [0080]    Bursting strength (kPa): measured according to ISO 13938-2: 1999 “Textiles—Bursting properties of textiles—Pneumatic method for determining the bursting strength and bursting deformation”, 5 samples 
         [0081]    Tensile strength (N/cm) is measured through a plunger test with a traction testing machine such as the Hounsfield model H5KS (Hounsfield, Redhill, England), crosshead speed: 50 mm/min, 5 samples: the burst pressure can be determined using a circular mesh sample with a radius of R m =56.4 mm and with a test area of 100 cm 2  clamped at the outward boarder (modified DIN 54307 superseded standard). Then, the mesh is loaded with a spherical stamp of a radius R s =50 mm, velocity v=50 mm/min until rupture occurs. Based on the measured forces and the resulting stretch, the tensile strength (N/cm) can be calculated; 
         [0082]    Tear strength (N) in the warp direction and in the weft direction: measured according to ISO 4674:1977  “Textiles covered with rubber or plastic—Determination of the tear strength”  Method A2, 5 samples, width: 75 mm, Tear length≦145 mm, crosshead speed: 100 mm/min, 
         [0083]    Thickness: is measured according to ISO 9073-2: 1997  “Textiles—test methods for nonwovens—Part  2:  Determination of thickness”,  10 samples, 100×50 mm, 
         [0084]    Tensile breaking strength and elongation at break: is measured according to ISO 13934-1: 2013  “Textiles—Tensile properties of fabrics—Part  1:  Determination of maximum force and elongation at maximum force using the strip method”,  5 samples, width: 50 mm, Length: 200 mm between the jaws, Crosshead speed: 100 mm/min, Pre-load: 0.5 N, using a traction testing machine such as the Hounsfield model H5KS (Hounsfield, Redhill, England); 
         [0085]    Effective porosity: pores having a diameter above 1 mm are measured with a profile projector such as a projector 300V from ORAMA, 1 sample of 100×50 mm; 
         [0086]    Suture pull out strength in the warp direction and in the weft direction measured according to NF S94-801: 2007 “Reinforcement implants introduced by the vaginal route for the treatment of stress urinary incontinence and/or of prolapse of the pelvic organs—pre-clinical trials and clinical trials”-§5.3.3 5 specimens 50×100 mm, USP 2 suture yarn, crosshead speed: 100 mm/min, using a traction testing machine such as the Hounsfield model H5KS (Hounsfield, Redhill, England). 
         [0087]    The results are collected in the following tables: 
         [0000]    
       
         
               
             
               
               
               
               
             
               
               
               
               
               
               
               
             
               
               
               
               
             
               
               
               
               
               
               
               
             
               
               
               
               
             
               
               
               
               
               
               
               
             
           
               
                 TABLE I 
               
             
             
               
                   
               
               
                 mechanical properties 
               
             
          
           
               
                   
                 Knit A 
                 Knit B 
                 Knit C 
               
             
          
           
               
                   
                 Warp 
                 Weft 
                 Warp 
                 Weft 
                 Warp 
                 Weft 
               
               
                   
               
               
                 Tensile  
                 175 ± 12 
                 129 ± 2  
                 187 ± 16 
                 149 ± 10 
                 237 ± 6  
                 201 ± 6  
               
               
                 breaking 
                   
                   
                   
                   
                   
                   
               
               
                 strength (N) 
                   
                   
                   
                   
                   
                   
               
               
                 Elongation  
                 54 ± 0 
                 50 ± 6 
                 43 ± 1 
                 59 ± 1 
                 38 ± 1 
                 46 ± 0 
               
               
                 under  
                   
                   
                   
                   
                   
                   
               
               
                 50N (%) 
                   
                   
                   
                   
                   
                   
               
             
          
           
               
                 Bursting  
                 280 ± 19 
                 361 ± 38 
                 463 ± 19 
               
               
                 strength  
                   
                   
                   
               
               
                 (kPa) 
                   
                   
                   
               
             
          
           
               
                 Tear  
                 22 ± 1 
                 23 ± 2 
                 23 ± 2 
                 22 ± 3 
                 30 ± 1 
                 37 ± 5 
               
               
                 strength (N) 
                   
                   
                   
                   
                   
                   
               
               
                 Suture  
                 32 ± 4 
                 36 ± 1 
                 33 ± 1 
                 33 ± 2 
                 46 ± 5 
                 42 ± 3 
               
               
                 pull out 
                   
                   
                   
                   
                   
                   
               
               
                 strength (N) 
                   
                   
                   
                   
                   
                   
               
             
          
           
               
                 Tensile  
                 24 ± 1 
                 40 ± 1 
                 47 ± 1 
               
             
          
           
               
                 strength  
                   
                   
                   
                   
                   
                   
               
               
                 (N/cm) 
               
               
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
               
               
             
               
               
               
               
             
           
               
                 TABLE II 
               
             
             
               
                   
               
               
                 mass per unit area and porosity 
               
             
          
           
               
                   
                 Knit A 
                 Knit B 
                 Knit C 
               
               
                   
                   
               
             
          
           
               
                 Mass per unit area (g/cm 2 ) 
                 45 
                 36 
                 46 
               
               
                 Thickness (mm) 
                   0.4 
                   0.4 
                   0.6 
               
               
                 Pore size (mm) (width × 
                 1.5 × 1.5 
                 1.6 × 1.4 
                 2.0 × 2.4 
               
               
                 height) 
               
               
                 Efficient porosity (%) 
                 53 
                 35 
                 55 
               
               
                   
               
             
          
         
       
     
         [0088]    With reference to Table I above, the knit of the invention (Knit C) shows improved mechanical properties in comparison with the knits of the prior art (Knits A and B). In particular, the knit of the invention shows a higher tensile breaking strength both in warp and weft directions than Knits A and B. The knit of the invention shows a higher bursting strength than Knits A and B. The knit of the invention shows a higher tear strength both in warp and weft directions than Knits A and B. 
         [0089]    The knit of the invention (Knit C) shows an improved suture pull out strength both in warp and weft directions compared to the knits of the prior art (knits A and B). The knit of the invention shows a higher tensile strength both in warp and weft directions than Knits A and B. 
         [0090]    With reference to Table II above, the knit of the invention further shows an improved efficient porosity compared to Knits A and B. 
         [0091]    In addition, the system described at  FIGS. 3 and 4  has been utilized to assess the following properties of knits A, B and C under various simulated physiological conditions. For proceeding to these measures, the textile-based implant  400  of  FIGS. 3 and 4  is replaced by the knit sample, either Knit A, B or C, to be evaluated. 
         [0092]    The following properties have been evaluated: 
         [0093]    1°) The shear forces distribution profile at fixation points of the knit: for each plunger force, namely 147 N respectively 304 N, the marker displacement as described above is transformed into the shear force at each fixation point where markers exist from the initial fixation position, using the mechanical continuum theory applied to the rods implemented in the software MATLAB® from the company Matchworks. The shear force vector is recorded. The Max and min vector norm values are recorded. The average distribution of shear forces at fixation points may be obtained under the following form: 

 
         [0094]    The shear forces distribution may be schematized by the following graphic profile: 

 
         [0095]    An Average force Min-Max (N) is determined: on the example of the profile above, the Average force Min-Max (N) at a plunger force of 147 N is 3.8-8 and the Average force Min-Max (N) at a plunger force of 304 N is 7.1-13.5 
         [0096]    For a knit, when the range of the value of the Average force Min-Max is low, the risks of failure of the knit are decreased. The knit and therefore the abdominal wall repair will be more efficient. 
         [0097]    In addition, the more the profile of the shear forces is close to a semi-circle or a semi-ellipse, the more regularly the shear forces are distributed. The risks of tensions in a specific direction are therefore decreased. In addition, the forces being of similar values in all directions, the knit may be implanted without having to check for a specific position of the warp or weft direction of the knit. The knit, or the prosthesis made from the knit, will also be more comfortable for the patient. 
         [0098]    2°) The bulging indication: corresponds to the distance in mm of penetration of the plunger  210  as described in  FIGS. 3 and 4 , from an initial position in which its contacting surface  212  is tangent to the sample knit to a final position obtained after application of the plunger force. 
         [0099]    A too high bulging indication, like for example above 50 mm at a plunger force of 304 N or for example above 45 mm at a plunger force of 147 N, may mean that the knit/prosthesis may be two soft for ensuring its reinforcement function of the abdominal wall, and/or may generate discomfort and/or aesthetics disturbance. 
         [0100]    3°) The rupture of knit at fixation: the number of ruptures at fixation points is recorded. 
         [0101]    The results are collected in the following table: 

 
         [0102]    As appears from the table above, the knit of the invention (Knit C) shows a regular contour profile very close to a semi-circle. The shear forces are therefore regularly distributed. The knit of the invention may therefore be introduced at the implantation site and implanted without the surgeon having to check previously for a specific positioning of the warp or weft direction of the knit. 
         [0103]    In addition, the number of fracture at fixation points is 0 for the knit of the invention, whereas it is 2 for the knits of the prior art (knits A and B). The knit of the invention is therefore more reliable once sutured or tacked to the surrounding biological tissues than the knits of the prior art. 
         [0104]    Regarding the bulging indication, the knit of the invention (knit C) shows a better bulging indication at both plunger forces than the knits of the prior art. The knit of the invention will therefore ensure its reinforcement function of the abdominal wall and will be more efficient than the knits of the prior art in physiological conditions such as jumping or coughing.