WO2019069173A1 - Non-resorbable biocompatible fabric that is suitable for being implanted, in particular in the pelvic region of a patient - associated prosthesis - Google Patents

Abstract

The present invention concerns a non-resorbable biocompatible fabric, having pores, that is suitable for being implanted, in particular in the pelvic region of a patient. According to the invention, the fabric characteristically has a density per unit surface area substantially equal to or greater than 16 g/m² and substantially equal to or less than 22 g/m² and substantially equal to 18 g/m², said pores are through-pores and comprise main pores that are optionally each surrounded by at least one secondary pore and said main pores have a mean diameter substantially greater than or equal to 1.5 mm and substantially less than or equal to 3.5 mm, preferably less than 3.0 mm and in particular equal to 2.1 mm. The invention also concerns a prosthesis, in particular for the treatment of vaginal prolapse, that comprises such a fabric.

Description

 NON-RESORBABLE BIOCOMPATIBLE TEXTILE, ABLE TO BE IMPLANTED, IN PARTICULAR AT THE PELVIC AREA OF A

 The present invention relates to a textile material that can be used in particular for the manufacture of a prosthesis for the treatment of female genital prolapse and such a prosthesis.

 Female genital prolapse is a very common pathology. Prevalence studies estimate that about 2/3 of women over the age of 60 are affected by prolapse. Prolapse, or organ descent, is characterized by the descent of one or more of the pelvic organs (ie the bladder, rectum, ovaries, and uterus) into the vagina. There is a grading scale of severity of prolapse, from moderate organ mobility (stage 1) to partial or complete reversion of the vagina (stage 4). This pathology can be accompanied by a number of symptoms: incontinence (s), feeling of bloating in the vagina, pain during sex ... Symptomatic prolapse can significantly reduce the quality of life of patients. The only perennial treatment goes through the surgical procedure, which can possibly be accompanied by a prosthesis.

 WO 2004/091443 A1 discloses a prosthesis for the cystocele treatment (or descent of the bladder) which comprises a support body or support portion from which extend arms or attachment straps. The suspenders or fixation arms are implanted through the patient's ligaments and thus allow the prosthesis to be placed and fixed in the patient's body.

US 2013/1 10137 A1 relates to a net for treating hernias. This net is in a non-resorbable biocompatible material and has pores having an average size between 0.4 mm ² and 10mm ^2, preferably between 0.2 mm ² and 7 mm ^2. This document indicates that the important parameter is not, in the case of the treatment of hernias, the pore sizes but their surface, regardless of their shape. The net density of the net can be 15 to 150g / m ² or 15 to 200g / m ² but indicates that the important parameter in the case of hernia treatment is the total weight of the prosthesis. This net also comprises a heparin-treated surface which makes it possible to prevent the prosthesis from adhering to the tissues of the patient's body.

 WO 2016/094669 A1 discloses multi-filament yarns that can be used for net manufacturing for hernia treatment, breast support, breast reconstruction and mastopexy. These nets may have a pore size ranging from 0.1 mm to 1 mm.

 The document WO 2004/017869 A1 describes an implant used for the treatment of hernias in particular. The implant is used to repair soft tissue. The fabric has open pores. This document does not describe the surface density of the fabric but refers to the area occupied by the threads relative to the total surface occupied by the textile which gives an idea of the area occupied by the pores but does not allow to calculate the grammage per unit area. These nets can be used to treat hernias, for plastic reconstruction or to treat occlusion of vessels.

 At present, genital prolapse cure prostheses continue to raise questions about their effectiveness and compatibility. Many national health organizations warn of the risk of significant complications following prosthesis insertion.

 A technical problem that the present invention intends to solve is to provide a novel biocompatible and non-absorbable textile material.

 Another technical problem that the present invention intends to solve is to provide a novel biocompatible and non-resorbable textile material which is more particularly adapted to the treatment of genital prolapse.

Another object of the present invention is to propose a material as mentioned above which, once implanted in the body, does not generate pain or discomfort for the patient and / or decreases the risk of exposure of the prosthesis.

 Another object of the present invention is to provide a material as mentioned above which when implanted in an organism does not significantly modify the mechanical properties of the biological tissue on which it is implanted, in particular, does not stiffen the biological tissue and / or does not modify the point of inflection of the stress curve vs relative elongation relative to the biological tissue and / or does not modify the maximum stress of the biological tissue.

 Another object of the present invention is to provide a prosthesis curing genital prolapse.

 [Brief description of the invention]

The present invention relates to a non-resorbable biocompatible textile, capable of being implanted, particularly at the level of the pelvic area of a patient, and of the type having pores. Characteristically, it has a density per unit area substantially equal to or greater than 16 g / m ² and substantially equal to or less than 22 g / m ² and in particular substantially equal to 18 g / m ² , said pores are through and comprise main pores optionally each surrounded by at least one secondary pore and said main pores have a mean diameter substantially greater than or equal to 1.5 mm and substantially less than or equal to 3.5, preferably less than 3.0 mm and in particular substantially equal to 2.1 mm.

It is the merit of the inventors to have found that the prostheses currently used, especially in the course of genital prolapse exhibit too much rigidity. A textile as aforesaid proves to be better tolerated by the body. Its surface mass is lower than that of textiles already used, which avoids too much disrupt the mechanical behavior of the biological tissue on which it is implanted. In particular, because of its surface mass as mentioned above with pores as mentioned above, the material of the invention does not disturb the point of inflection of the stress-elongation curve of the biological tissue and / or does not modify the maximum stress that can support the biological tissue. The aforementioned pore size achieves good adhesion of the textile to the biological tissue while minimizing the contact area between the two, reducing the risk of inflammation and infection.

[Detailed description]

 Advantageously, according to a particular embodiment, the textile has a first tensile strength value, measured in a first direction, substantially equal to or greater than 55N / 5cm and substantially equal to or less than 95N / 5cm. Such a textile has generated a low rate of complications. Because of its flexibility conferred by the aforementioned parameters, it limits the post-implantation retraction. The phenomena of cicatricial retraction are known in the literature, it is preferable that they are the weakest possible in amplitude to avoid complications or patient pains.

 According to another embodiment which can be combined with that mentioned above, the textile comprises at least one secondary pore, in particular three secondary pores, arranged around each main pore and said secondary pores have an average diameter greater than or equal to 0.5 mm and less than or equal to 1, 5mm and in particular substantially equal to 0.9mm. The inventors have indeed demonstrated that the pores as mentioned above made it possible to obtain a light and flexible textile, but sufficiently strong to reinforce an injured biological tissue, in particular an injured pelvic tissue.

 According to a particular embodiment which can be combined with any one of the aforementioned embodiments, said main pores are polygons, and in particular hexagons, form rows and any secondary pores are substantially triangular and are separated one by one. on the other side of said main pore.

Preferably, the textile has secondary pores, preferably 3 and preferably of triangular shape and separated from each other by one side of said main pore, which is preferably hexagonal and has a shorter side length than the other sides . Advantageously, the textile has a number of columns per centimeter substantially equal to or greater than 2.5 and substantially equal to or less than 3.5 and in particular 3 and a number of lines per centimeter substantially equal to or greater than 1 1 and substantially equal to or less than at 14 and in particular 13.5. These values give it a specific mass density and mechanical properties.

 Advantageously, the textile has a relative isotropy. Since biological tissues have mechanical properties and in particular an isotropic elongation at break, the inventors have sought to give the textile a certain isotropy. It has been found that when the elongation values at break in two perpendicular directions are as indicated below, the textile, when implanted on a biological tissue, does not disturb the isotropy of the latter. .

Thus, according to a particular embodiment that can be combined with any one of the aforementioned embodiments, the textile of the invention has a first elongation value at break ALR1 measured in a first direction and a second value. elongation at break ALR2 measured in a second direction, perpendicular to said first direction. Typically, according to this particular embodiment, said second elongation value at break ALR2 belongs to the following interval: [first elongation value at break -20% of said first elongation value at break ; first elongation value at break + 20% of said first elongation value at break], including terminals, and said first elongation value at break is notably substantially equal to or greater than 68% and substantially equal to or lower than at 102% and in particular substantially equal to 71%, in particular 85% or 89%. Such a textile exhibits a sufficiently isotropic mechanical behavior so as not to disturb the isotropy of the mechanical behavior of the biological tissue; it also has the advantage of modifying neither the maximum stress of the biological tissue nor the point of inflection of the stress-elongation curve of the latter. Advantageously, whatever the embodiment, the textile may consist essentially of a knit, preferably formed exclusively of a knit, and said knit is heat-set, especially at a temperature between 120 ° C and 150 ° C. The inventors have also found that the thermo fixation makes it possible to confer and fix the mechanical properties of the textile. The thermo fixation allows to shape the textile, without giving it a three-dimensional structure, the fabric remaining flat.

 According to the invention, the textile may be formed of a plurality of threads, themselves formed of a plurality of filaments.

 Advantageously, according to the invention, the textile comprises or is formed of a yarn or a monofilament of diameter substantially equal to or less than 100 μm and in particular substantially equal to 80 μm and which has a linear density substantially equal to or greater than 30 dtex and substantially equal to or less than 70dTex and in particular substantially equal to 46dTex. Such a monofilament makes it possible to confer the desired mechanical properties on the textile, in particular on a knitwear. Advantageously, the textile comprises or is formed of a polypropylene monofilament having a diameter of 100 μm and a linear density of 71 dTex.

 The present invention also relates to a prosthesis, in particular for the treatment of genital prolapse, of the type comprising a support portion adapted in particular to come into contact with the tissue. Typically, according to the invention, said support portion comprises said textile according to the invention.

 According to a particular embodiment, the prosthesis further comprises at least one pair of attachment arms which extends from said support portion and, preferably, said arms consist essentially of or consist of the same material as said portion. Support

[Definitions]

The term "genital prolapse" refers to any protrusion of a pelvic organ through the vulvovaginal orifice. The term "pelvic organ" includes any organ or group of organs selected from the bladder, rectum and uterus.

 The term "through pore" means within the meaning of the present invention a day formed in the textile and which defines an opening in the thickness of the latter. The terms "day" and "pore" are used interchangeably in the present application to designate a pore crossing as mentioned above.

 The term "average diameter" in reference to the pores of the textile refers to the average of the major axis and the minor axis of the ellipsoidal shape which has substantially the same surface as the pore in question. The method of measuring the average pore diameter is indicated later in this application.

 The term "biocompatible material" refers to any material capable of being integrated into a patient's body without generating a reaction from the patient's body such as to require removal of the material prior to obtaining the desired therapeutic effect. It may be, for example, a polymer, natural or synthetic, or a mixture of polymers. It may be, for example, polypropylene suitable for medical use or polytetrafluoroethylene.

 The term "textile" refers to a fabric, knit or material that combines at least two of these textile forms. A textile according to the invention can be obtained from a single thread, possibly a monofilament or from several threads.

 The term "isotropy" in reference to a mechanical property, indicates that the values of the same parameter measured in a first direction and in a second direction perpendicular to the first are equivalent, that is, they are either equal to or within an interval that depends on the nature of the measured parameter.

[Figures]

The present invention, its characteristics and the various advantages and technical effects that it provides will appear better on reading the following description of a particular embodiment, presented as a illustrative nonlimiting example and which refers to the appended drawings among which:

 FIG. 1 represents a view from above, of a particular embodiment of the prosthesis according to the invention;

 FIG. 2 shows a magnified top view of the support portion of the prosthesis shown in FIG. 1;

 FIG. 3 represents the 9 textile samples tested;

 - Figs. 4a to 4c show the elongation curves as a function of the tensile force exerted on each of the samples of FIG. 3, in the warp and weft directions;

 - Figs. 5a to 5c show the modification and dispersion of the maximum stress of the textile / biological tissue composite, which is obtained by implantation of each of the textiles shown in FIG. 3;

 FIG. 6 represents the mechanical behavior of a tissue of biological origin as a function of the tensile force imposed on it; this figure also indicates the different areas of behavior of the fabric as well as the change of slope.

 [EXAMPLES]

 [Example of embodiment of a prosthesis]

With reference to FIG. 1, a particular embodiment of the prosthesis according to the invention will now be described. The prosthesis according to this particular embodiment comprises a central zone or support portion 1. The support portion 1 is here substantially rectangular and has two rounded and concave ends in the plane of the prosthesis. The support portion 1 has on its two opposite sides the longest, a connecting strip 3. The connecting strip 3 is extended in three pairs of attachment arms which are arranged symmetrically with respect to the support portion 1 (the prosthesis is itself symmetrical about a longitudinal axis passing through the support portion 1): the rear arms 51 which frame a concave end of the support portion 1, the two front arms 55 which frame the end opposite to that provided with 51 back arm and arms Intermediates 53. These arms are used for the installation and fixation of the prosthesis in the body of the patient.

 The density of the textile forming the support portion 1 may be different from that of the textile forming the arms and / or the connecting strip. The support portion can thus be less dense than the arms and / or the connecting strip. The invention is nevertheless not limited to this particular embodiment. A prosthesis as aforesaid which is formed of a single textile is also part of the invention.

 [Particular example of a pattern according to one embodiment of the invention] A knit is made from a polypropylene monofilament yarn

(suitable for a medical application, USP Class VI), diameter 80pm (titration: 46 dTex). With reference to FIG. 2, the embodiment of the textile according to the invention shown here comprises substantially hexagonal main pores. The hexagons are all identical but do not have 6 sides of the same length. The hexagons are separated from each other by pores or secondary days. With reference to FIG. 2, a hexagonal main pore H has on three of its non-adjacent sides two-to-two, a triangular day T1, T2 and T3. The hexagons H are aligned and form rows. The set formed by a hexagon H and its three secondary pores T1, T2 and T3 is in a triangle. The secondary pores T1, T2 and T3 are identical and have a base which extends in a horizontal direction in FIG. 2, which represents the direction of the knit fabric. Substantially pentagonal days P1, P2 and P3 separate the aforementioned triangular days from each other. The triangular days T1, T2 and T3 and the main days H are each surrounded by oblong days O. In FIG. 2, the vertical axis corresponds to the direction of manufacture of the knitting (warp direction). This pattern corresponds to sample IIIB ₄ which is shown in FIG. 2 and will be studied in more detail later in the present application. Only the size of the main pores and the secondary pores were determined. The size of the pores O and P1, P2, P3 has not been determined.

[Study of the mechanical behavior of textiles] 9 knits were made which are shown in FIG. 3. They are all knitted from polypropylene yarn, medical grade (USP Class VI), diameter 80 μm. All the knits were subjected to a desizing step followed by a thermo setting step at 145 ° C. which was also used to dry them. The knits are flat. The number of rows, the number of columns, the basis weight and the pore size were then determined for each of the samples shown in FIG. 3. These same knits are used for in vivo study.

 In FIG. 3, the samples are grouped into three banks or groups, bank I on the first line, bank 2 on the second and bank three on the third line.

 The mechanical characteristics of knits are summarized in Table I below. The basis weight is measured according to standard NF EN 12127.

The average pore diameter is measured according to the following method: the textile samples are cut and dyed with a spray of light-colored paint. They are placed on a black background to maximize the contrast. Images of the knit with a graduated mark are taken with a Canon camera equipped with a macro lens (Canon EF 100mm f / 2.8 Macro USM). The image processing is done with the ImageJ 1 .46r software developed by the National Institutes of Health. The pixel-mm correspondence is indicated by the graduated mark of the image obtained. The image is then binarized by an automatic thresholding based on the histogram of the image. OTSU type thresholding is used here as described in the N. OTSU publication. "A Threshold Selection Method from Gray-Level Histograms". In: IEEE Trans. Syst. Man. Cybern. 9.1 (1979), p. 62-66. This method considers that there are only two classes of pixels in the image. The differentiation threshold is determined so that the variances of each of these two classes are minimized. This makes it possible to identify the regions inside the wires. The analysis of these zones assimilates each pore to an ellipse whose major axis has and the small axis b are expressed in mm. The value of the diameter assigned to the pore is the average value calculated from a and b is ((a + b) / 2).

 The results obtained are summarized in Table I below.

TABLE I

The elongation is determined using five uni-axial tensile tensile tests (warp or weft). They are conducted according to standard NF EN ISO 13934-1 on 20 cm long specimens between the jaws per 5 cm wide in the weft direction and in the warp direction. The test machine is equipped with a force sensor of 2500 N. The elongation is calculated by traverse displacement, ε = ΔΙ / Ι0.

The elongations as a function of the force exerted were measured for each of the samples in the weft direction and in the warp direction. The results are shown in Figs. 4a to 4c. These results highlight the anisotropy between the warp and weft directions: the knits produced do not always have a similar response in the two main directions. Nevertheless, apart from the sample referenced III. D, the textiles of bench III have a relatively low rate of anisotropy. Since biological tissues, especially pelvic tissues, are isotropic, a textile is preferably chosen which is also relatively isotropic in order to disrupt as little as possible the mechanical behavior of the composite which is obtained after implantation of the textile and cicatrization.

 From the force-elongation curves shown in FIGS. 4a to 4c, the forces and elongations at break, as well as the slopes in small and large deformations were determined. They are respectively calculated on the first 20 and last 25 percent of deformations of the curve. The average data obtained in the warp direction are listed in Table II below.

TABLE II

Table III below groups the values for the frame direction.

TABLE III

 Weft direction

 Deformation Force rupture

 Name Initial Slope (N) Final Slope (N)

 rupture (%) (N / 5cm)

I A1 0.25 2.37 84 1 15

[EXPERIMENTAL RESULTS]

 Study of the in vivo implantation of textiles

 For the animal study that follows, the textiles that have been implanted are always cut so that the warp direction is in the length of the implant, the uni-axial test is always done in the warp direction. This one does not make it possible to account for the phenomenon of coupling (influence of the chain stress on the weird request) of the behavior of the implanted textile which could take place in the body during a multiaxial solicitation.

 In the three test benches, the nine textile samples were implanted on the abdominal wall of rats. Explantation occurs after 3 months. Before the mechanical characterization of the implanted textile, the first observations are made at the time of explantation of the textile and are necessarily clinical. Thus the values of cicatricial retraction and the complications according to the type of textile are noted.

 Table IV below recalls the complications observed during the study.

TABLE IV

Name Death Number Exposure i Tumefaction Remarks

initial

Exposures or erosions represent the most clinically disturbing complications.

 The swelling had no impact on the mechanical characteristics of the prostheses. When looking at the number of complications between the banks I, II and III, we observe a significant increase in the number of swelling on the bench III. This is not due to a modification of the implantation protocol of the prostheses, but to a change of operator between the bench II and the bench III. Regular and attentive follow-up in the first days following the implantation of the animals made it possible to resume the sutures or drain the hematomas so as to reduce any aggravation of the phenomenon. At the time of explantation, they were no longer visible.

 It is easy to see that the rates of complications decrease during test beds. There are two reasons for this. On the one hand, minor complications, such as hematoma or swelling, are less important thanks to the growing experience of the operator who performs the implantations. On the other hand, major complications, such as exposures (visible prosthesis on the skin) much less frequent during banks II and III, can be explained by the lower stiffness and the lower density of textiles.

Throughout the in vivo study that follows, the textile samples are explanted three months after their implantation. The wall is then cut abdominal of the animal. The object studied is a composite that includes a layer of biological tissue that corresponds to the abdominal wall of the animal (the entire thickness of the animal), the scar tissue that has formed and the textile itself.

Study of the maximum stress before damage for the three benches of knits

 The placebo group is a group of rats that have received no implants but have undergone surgery. The control group is rats that have not undergone any surgery.

 Figs. 5a to 5c group for each bench of textile samples, the maximum stress measured on the composite textile / biological tissue, before damage (tearing, rupture). The maximum stress is the maximum force that can support composite before it is damaged. The values are measured directly on the stress-elongation experimental curve of each composite obtained by implantation of each of the textile samples shown in FIG. 3. The value of the maximum stress for the biological tissue alone (ie the abdominal membrane of the placebo group) is then compared with that obtained for the composite.

In view of the results grouped together in FIGS. 5a to 5c, it is found that the most suitable textile and which therefore changes as little as possible the value of the maximum stress (or maximum tensile force) supported by the biological tissue is the textile III. B ₄ .

Study of rigidities

 The modeling of the mechanical behavior of a tissue of biological origin uses a model of energy density of Yeoh type of order at least 2, that is to say:

W (li) = Co (Li-3) + C (h-3) ² in which Co describes the linear approximation in small deformations. It represents a Young's modulus apparent at the origin and characterizes the rigidity in small deformations. Ci specifies the behavior asymptotic in large deformations. It reports rigidity in large deformations.

For all benches, two-to-two comparisons between control and placebo groups do not show any significant difference in large deformities (p ^c1 = 0.37). It confirms observations of research of influence of healing: influence of scar tissue is not detectable.

 In order to observe relevant evolutions, the values of Co and Ci were compared for the different textile benches. The variations are variations established within the same bench.

 Table V below groups the apparent rigidity values of the control and placebo groups for each of the banks. Indeed, the tests were not performed at the same time but successively. The same control group and the same placebo group could not therefore be used for all groups of textiles.

TABLE V

Table VI below groups the apparent stiffness values of explants with prosthesis, that is to say composites as defined above.

TABLE VI

 Co - Rigidities in small Ci - Rigidities in big

Name deformations (MPa) deformations (MPa)

Qi Cb Qi Cb Median median

 A1 0.003 0.002 0.004 0.01 0.008 0.012

I A2 0.009 0.008 0.013 0.05 0.043 0.063

 A3 0.005 0.002 0.008 0.03 0.028 0.052

A2 0.003 0.002 0.0045 0.05 0.02 0.06

B1 0.003 0.002 0.0037 0.024 0.018 0.04

II

 B2 0.003 0.003 0.006 0.022 0.017 0.048

B3 0.003 0.002 0.0035 0.018 0.015 0.031

B4 0.004 0.002 0.005 0.028 0.02 0.05

III C 0.004 0.003 0.0047 0.055 0.032 0.072

 D 0.004 0.003 0.005 0.047 0.033 0.07

In view of the results grouped in Tables V and VI, the textile III B ₄ seems to be the most satisfactory with regard to the criterion of rigidities. It does not alter the rigidities in large deformations of the biological composite (which is formed of the abdominal wall- scar tissue- textile) in comparison to the biological tissue only also known as native tissue.

Study of the point of inflection

 As shown in FIG. 6, the point of change of slope between small and high rigidity represents the transition from a physiological comfort zone to an extreme zone where the biological tissue is highly stressed. When the biological tissue is too heavily stressed, it can cause discomfort or pain. It has therefore been determined which composite replacing the native fabric also retains the same zone of physiological deformability. Table VII below presents the median results and the interquartile differences measured according to the implanted textiles. The comparisons are conducted within each of the benches and relative to the "placebo" animal control group of each bank.

TABLE VII

 Slope change (%)

 Name

 Median Q1 Q3

I Placebo 29.5 23.3 37

In view of the results indicated in the above-mentioned Table VII, it can be seen that the prostheses I.A2 and I.A3 have a strong impact on the crossing point, p ^{I A2} = 0.01 and p ^{I A3} = 0.03. As regards bank II, the point of inflection is again significantly displaced by the A2 textile (p ^{II A2} = 0.001). Finally, the bench III makes it possible to identify a textile which, when it is implanted, makes it possible to obtain a composite which has a point of inflection which is not displaced with respect to the point of inflection of the biological tissue: it is is the textile III. B ₄ (p ^{III B4} = 0.35). On the contrary, prostheses III. C and III. D seems to limit the zone of low rigidity (p " ^lc = 0.07, p '" ^D = 0.03), as indicated in Table VII.

Claims

1. Biocompatible nonabsorbable textile capable of being implanted, particularly at the level of the pelvic area of a patient, of the type having pores, characterized in that it has a substantially equal density per unit area or greater than 16 g / m ² and substantially equal to or less than 22 g / m ² and in particular substantially equal to 18 g / m ² , in that said pores are through and comprise main pores (H) optionally each surrounded by at least one pore secondary (T1; T2; T3) and in that said main pores (H) have a mean diameter substantially greater than or equal to 1.5mm and substantially less than or equal to 3.5, preferably less than 3.0mm and in particular substantially equal to 2.1 mm.  2. Textile according to claim 1, characterized in that it has a first tensile strength value, measured in a first direction, substantially equal to or greater than 55N / 5cm and substantially equal to or less than 95N / 5cm.  3. biocompatible textile according to claim 1, characterized in that it comprises at least one secondary pore, in particular three secondary pores, arranged around each main pore and in that said secondary pores have an average diameter greater than or equal to 0, 5mm and less than or equal to 1, 5mm and in particular substantially equal to 0.9mm.  4. Textile according to any one of the preceding claims, characterized in that said main days are polygons, including hexagons, in that they form rows and in that the possible secondary pores are substantially triangular and are separated from each other by one side of said main pore. 5. Textile according to claim 4, characterized in that it has a number of columns per centimeter substantially equal to or greater than 2.5 and substantially equal to or less than 3.5 and in particular 3 and a number of lines per centimeters substantially equal to or greater than 1 1 and substantially equal to or less than 14 and in particular 13.5.  6. Textile according to any one of the preceding claims, characterized in that it has a first elongation value at break ALR1 measured in a first direction and a second elongation value at break ALR2 measured in a second direction perpendicular to said first direction, characterized in that said second elongation value at break ALR2 belongs to the following range: [first elongation value at break -20% of said first elongation value at break ; first elongation value at break + 20% of said first elongation value at break], including terminals, and in that said first elongation value at break is in particular substantially equal to or greater than 68% and substantially equal to or less than 102% and in particular substantially equal to 71%, in particular 85% or 89%. 7. Textile according to any one of the preceding claims, characterized in that it consists essentially of a knit, preferably formed exclusively of a knit, and in that said knit is heat-set, especially at a temperature between 120 ° C and 150 ° C. 8. Textile according to any one of the preceding claims, characterized in that it comprises or is formed of a wire or a monofilament of diameter substantially equal to or less than 100pm and in particular substantially equal to 80pm and which has a linear density substantially equal to or greater than 30dTex and substantially equal to or less than 70dTex and in particular substantially equal to 46dTex. 9. Prosthesis, in particular for the treatment of genital prolapse, the type comprises a support portion adapted in particular to come into contact with the fabric, characterized in that said support portion comprises said textile according to any one of claims 1 to 7. The prosthesis according to claim 9, characterized in that it further comprises at least one pair of attachment arms which extends from said support portion and that, preferably, said arms are essentially constituted or made of the same material as said support portion.