Method for inducing an improvement in the mechanical resistance of an implantable device comprising one or more PLA wire(s) at the end of a determined hydrolysis, and implantable device capable of being obtained by said method

Abstract

The present invention relates to a method for inducing an improvement in the mechanical strength (N / cm) of an implantable device after a determined period of hydrolysis, said method comprising:i)- a step of providing an implantable device comprising one or more wires comprising at least one lactic acid (co)polymer;ii)- a step of treating said implantable device with supercritical carbon dioxide (CO2);iii)- a step of obtaining an implantable device having a mechanical strength greater than or equal to 10 N / cm, preferably greater than or equal to 25 N / cm, after 20 weeks of hydrolysis, in particular in an aqueous medium. The present invention also relates to an implantable device obtainable by said method, and the use of supercritical (CO2) for inducing an improvement in the mechanical strength of an implantable device comprising one or more wires comprising a lactic acid (co)polymer.Figure for abstract: Fig.5.

Description

Title of the invention: Method for inducing an improvement in the mechanical resistance of an implantable device comprising one or more PLA wire(s) at the end of a determined hydrolysis, and implantable device capable of being obtained by said method Technical field

[0001] The present invention relates to the technical field of implantable devices which are at least partly resorbable and at least partly textile, in particular for the treatment of hernias, having improved mechanical resistance after a determined prolonged hydrolysis period.

[0002] The present invention also relates to the technical field of methods for improving the mechanical resistance at the end of a prolonged hydrolysis period of implantable devices which are at least partly textile and at least partly resorbable, in particular for the treatment of abdominal hernias. Prior art

[0003] It is known to use implantable devices which are at least partly textile and at least partly resorbable or non-resorbable for the treatment of abdominal hernias.

[0004] These implantable devices generally comprise an implantable textile panel, at least partly resorbable or non-resorbable, substantially flat and / or comprising a three-dimensional anatomical shape to fill a parietal defect. The textile panel is generally a knit or a fabric, for example a knit made of monofilament yarns providing sufficient mechanical strength, made of polypropylene or polyethylene for example when non-resorbable or P4HB when resorbable for example. When the reinforcing textile panel is non-resorbable, it is intended to remain implanted in the patient during hernia treatment. When the reinforcing textile panel is resorbable, it is intended to be hydrolyzed by the patient's natural implantation environment which is an aqueous environment and therefore to disappear after a determined period.

[0005] The choice of an absorbable or non-absorbable implantable device depends in particular on the type of patient, in particular if the latter presents risks such as obesity, diabetes, smoking, or presents a combination of these different risks.

[0006] It has been observed that patients presenting one or more of the risk factors stated above are more prone to the risks of recurrence of an abdominal hernia, and especially to infections at the level of the implantable device. These infections when they cannot be treated with drug therapy requires surgery to remove the implantable device. These infections generally occur after a period of several months. Surgical practice in the field of ventral hernia treatment thus tends to no longer use polypropylene or polyester implantable devices, i.e. non-resorbable, to treat patients with risk factors for infections because they will be required to undergo corrective surgery to remove the implantable device. In order to overcome this disadvantage, patients with risk factors for infection are treated with absorbable implantable devices.For the treatment of abdominal hernias for these patients at risk of infection, we know of the implantable device marketed under the brand name PHASIX® with absorbable P4HB threads with complete resorption after 18 months. Thus, in the event of infections after several months of implantation, it is not necessary to remove the implanted device.

[0007] The absorbable implantable devices available on the market allow the infection to be treated relatively correctly without having to explant the implanted device (since it disappears completely in the long term) but the probability of the hernia recurring is greater.

[0008] For patients with risks of infections, the majority of recurrences appear before the end of the first year after implantation, i.e. around 12 months. These recurrences which occur during the first year appear on the periphery of the implanted device, i.e. on anatomical areas not covered by the implanted device. Beyond the first year, recurrences appear on the anatomical areas covered by the resorbable implanted device, which breaks due to a loss of resistance due to degradation by hydrolysis.

[0009] It is thus sought to improve the mechanical resistance of the resorbable implanted devices during hydrolysis, and this several months after the start of hydrolysis, in order to avoid a recurrence of the hernia.

[0010] The publication entitled “In Vitro Degradation of Poly(L-lactic acid) fibers produced by melt spinning”; A.Pegoretti, L.Fambri, C.Migliaresi, Department of Materials Engineering, University of Trento, via Mesiano 77, 38050 Trento, Italy, highlights that the mechanical properties of fibers with smaller diameters (approximately 72 pm) degrade faster than those of fibers with a larger diameter (approximately 120 pm) under the effect of PLLA hydrolysis. This study highlights that the degradation rate would depend on many factors, including the type of polymer, the PLLA manufacturing conditions (melt- or solvent-based) and the degradation medium. In particular, the lower the surface / volume ratio and the higher the initial molar mass, the higher the degradation rates of the molar mass and the mechanical properties. canics are slowed down. It is noted that after 16 weeks (4 months), the breaking strength (MPa), recorded in [Fig.6], falls from 900 MPa to approximately 225 MPa for a monofilament with a diameter of 120 microns, i.e. a loss of mechanical strength of around 75% for a hydrolysis period of 4 months. For fibers with a diameter of 72 microns, the breaking strength falls from 975 MPa to 110 MPa after 4 months of hydrolysis (i.e. a loss of mechanical strength of 89%, see figure 7b). The 120 pm fibers retain a breaking strength higher than that of the 72 pm fibers but the degradation of the breaking strength is greater than or equal to 75% in both cases after a hydrolysis period of 4 months in a buffered solution at pH 7.4 and at a temperature of 37°C.

[0011] The person skilled in the art is thus encouraged to increase the diameter of the filaments of the implantable devices in order to delay the loss of mechanical resistance, however, a loss of mechanical resistance that is too significant (70%) is observed after 4 months. However, mechanical resistance is sought which is not too low after 4 months, or even still significant after 5 months, and after 8 months, since the risks of infections and recurrence are greater around 12 months.

[0012] Furthermore, it is not possible to implement filaments having too large a diameter because the implantable device must remain flexible, in particular sufficiently so that it can be rolled up on itself and placed in an insertion trocar of a few mm in diameter and then unrolled on the implantation site.

[0013] It has thus been proposed to add a resorbable coating on the filaments themselves resorbable in order to delay the hydrolysis of said threads, and defer the loss of mechanical resistance. Nevertheless, this arrangement requires a step of coating the threads, and tends to stiffen the threads, which is to the detriment of the patient's comfort, and reduces the flexibility of the implantable device.

[0014] The present invention thus relates to a method for inducing an improvement in the mechanical resistance to hydrolysis, in particular in an aqueous medium, of an implantable device comprising one or more monofilament thread(s) made of lactic acid (co)polymer(s), and this without loss of the flexibility of said implantable device so that it can be inserted into a trocar.

[0015] The present invention also relates to a fully or partially resorbable implantable device, comprising one or more threads made of lactic acid (co)polymer, and having improved mechanical resistance to hydrolysis, in particular in an aqueous medium, in particular at 5 months and / or at 8 months. Statement of the invention

[0016] The present invention addresses the aforementioned problems in that it relates, according to a first aspect, to a method for inducing an improvement in resistance mechanical (N / cm) of an implantable device after a determined period of hydrolysis of said implantable device, in particular measured in weeks or months, said implantable device comprising one or more wires comprising at least one lactic acid (co)polymer, said method further comprising, said steps advantageously taking place in this order: i)- a step of providing an implantable device comprising one or more wires comprising at least one lactic acid (co)polymer; ii)- a step of treating said implantable device with supercritical carbon dioxide (CO2); iii)- a step of obtaining an implantable device having a mechanical resistance greater than or equal to 10 N / cm, or 15 N / cm, or 20 N / cm, or 22 N / cm, preferably greater than or equal to 25 N / cm or 27 N / cm or 29 N / cm, after 20 weeks of hydrolysis, in particular in an aqueous medium.

[0017] It has been surprisingly discovered that the treatment with CO2sc of an implantable device which is at least partly textile and at least partly resorbable, with threads made of lactic acid (co)polymer makes it possible to improve the mechanical resistance of this implantable device during its hydrolysis.

[0018] Thus, it has been observed that an implantable device at least partly textile comprising monofilament threads made of lactic acid (co)polymer treated with CO2 sc has a mechanical resistance (N / cm) multiplied by at least three at 5 months of hydrolysis compared to an identical implantable device not treated with CO2 sc. Implantable device

[0019] Preferably, the implantable device comprises, in particular, a flat or three-dimensional textile plate or comprising a flat part and a three-dimensional part.

[0020] In the present text, the expression "flat textile plate or flat part" means that this part or this plate extends in a two-dimensional plane, along axes x and y, the thickness of the plate or of the part being insignificant and / or not considered.

[0021] In the present text, a three-dimensional textile plate or three-dimensional part is understood to mean that this part or this plate extends in three dimensions, along axes x, y and z, the thickness of the plate or part being measured along the z axis.

[0022] Preferably, the implantable device comprises one or more textile(s), in particular one or more textile panels, knitted and / or woven and / or braided, more preferably knitted.

[0023] Preferably, the implantable device, in particular the textile or the textile panel, has a surface mass greater than or equal to 10 g / m2, or 20 g / m2 or 30 g / m2 or 40 g / m2.

[0024] More preferably, the implantable device, in particular the textile or the textile panel, has a surface mass greater than or equal to 50 g / m2, or 60 g / m2 or 70 g / m2 or 80 g / m2 or 90 g / m2 or 100 g / m2, preferably greater than or equal to 110 g / m2.

[0025] Preferably, the implantable device, in particular the textile or the textile panel, has a surface mass less than or equal to 300 g / m2, or 250 g / m2 or 230 g / m2, or 220 g / m2 or 200 g / m2, more preferably less than or equal to 190 g / m2 or 180 g / m2.

[0026] Advantageously, the flat or three-dimensional textile plate comprises, or is essentially made up of, one or more textile(s).

[0027] In one embodiment, the knit is a weft or warp knit (i.e., warp).

[0028] Preferably, the implantable device comprises, or the textile or the textile plate is, a warp knit, more preferably said warp knit comprises one or more monofilament yarn(s).

[0029] Preferably, the implantable device is arranged for the treatment of an abdominal hernia, for example ventral or inguinal.

[0030] Advantageously, the implantable device is at least partly textile.

[0031] Advantageously, the implantable device and / or the textile and / or the textile plate is / are at least partly resorbable, preferably at least 50% or 60% or 70% or 80% or 90% or 95% or 99% or 100% approximately by mass of the implantable device or the textile or the plate is resorbable.

[0032] In the present text, the term "resorbable" is understood to mean that part or all of the implantable device and / or a textile and / or a textile plate is resorbable by hydrolysis, that is to say that it is chemically and / or mechanically degraded progressively by hydrolysis in an aqueous medium at room temperature (for example at a temperature greater than or equal to 20°C, or 37°C) at the end of a determined period and / or once implanted in a living organism (bioresorbable), in particular a mammal, more particularly the human body, at the end of a determined period by hydrolysis, for example 4 months or 5 months or 8 months or 10 months or 12 months or more.

[0033] A textile may comprise one or more monofilament yarn(s) and / or one or more multifilament yarn(s).

[0034] Preferably, the aqueous medium comprises at least 50% or 60% or 70% or 80% or 90% by mass or by volume of water, in particular distilled and / or osmosed water.

[0035] Preferably, the aqueous medium has a pH greater than or equal to 6 and less than or equal to 8, more preferably greater than or equal to 6.5 or 6.7 or 6.8 or 7.0 or 7.2, preferably less than or equal to 7.8 or 7.6.

[0036] For example, the aqueous medium has a pH of the order of 7.4 to + / - 0.1.

[0037] Preferably, the aqueous medium is buffered with phosphate buffered saline (PBS).

[0038] Preferably, a monofilament yarn has a diameter greater than or equal to 0.01 mm, more preferably greater than or equal to 0.05 mm, preferably greater than or equal to 0.10 mm.

[0039] Preferably, a monofilament yarn has a diameter less than or equal to 3 mm, more preferably less than or equal to 2 mm or 1 mm or 0.80 mm, preferably less than or equal to 0.70 mm or 0.60 mm or 0.50 mm or 0.40 mm or 0.30 mm or 0.20 mm.

[0040] Preferably, the monofilament and / or multifilament thread(s) each comprise(s), or is / are made of, one or more (bio)resorbable materials chosen from: a lactic acid polymer of L or D form or of L and D forms, a glycolic acid polymer, a copolymer of lactic acid (L and / or D) and glycolic acid, polycaprolactone, poly-4-hydroxybutyrate (P4HB), or a mixture thereof.

[0041] The L form (Levorotatory) and the D form (Dextrorotatory) are two isomers of lactic acid.

[0042] The lactic acid polymer may be a homopolymer or a copolymer.

[0043] In the present text, the term copolymer means any polymer comprising at least two different repeating units, and optionally at least three different repeating units (for example a terpolymer).

[0044] The term “lactic acid (co)polymer” means a homopolymer of lactic acid (comprising repeating units of L form and / or D form), and any copolymer comprising at least repeating units of lactic acid (comprising repeating units of L form and / or D form) and repeating units other than lactic acid, for example glycolic acid.

[0045] In one embodiment, the monofilament yarn(s) each have an elongation at break of less than or equal to 100%, in particular less than or equal to 70%, more particularly less than or equal to 60% or 50% or 45%.

[0046] Advantageously, the monofilament yarn(s) each have an elongation at break greater than or equal to 10%, in particular greater than or equal to 15% or 20%.

[0047] In one embodiment, the monofilament yarn(s) each have a tenacity (cN / dtex) greater than or equal to 1 cN / dtex, preferably greater than or equal to 2 or 3 cN / dtex.

[0048] Advantageously, the monofilament yarn(s) each have a tenacity (cN / dtex) less than or equal to 30 cN / dtex, preferably less than or equal to 20 cN / dtex, more preferably less than or equal to 15 cN / dtex, in particular less than or equal to 10 cN / dtex.

[0049] In one embodiment, the monofilament yarn(s) each have a breaking load greater than or equal to 300 cN, preferably greater than or equal to 400 cN or 500 cN or 600 cN or 700 cN or 800 cN.

[0050] Advantageously, the monofilament yarn(s) each have a breaking load of less than or equal to 3000 cN, preferably less than or equal to 2000 cN or 1500 cN.

[0051] The breaking load, tenacity, and elongation at break of the monofilament yarn were measured according to standard EN 13895 dated June 2003, and entitled “Textiles - Monofilaments - Determination of tensile properties”.

[0052] In one embodiment, the monofilament yarn(s) each have a linear density (dtex) greater than or equal to 50 dtex, preferably greater than or equal to 100 dtex or 150 dtex or 180 dtex or 200 dtex.

[0053] Advantageously, the monofilament yarn(s) each have a linear density (dtex) less than or equal to 800 dtex, preferably less than or equal to 700 dtex or 600 dtex or 500 dtex or 400 dtex or 300 dtex, for example of the order of 220 dtex to + / - 50 dtex.

[0054] The linear mass is measured using the NF EN 13392 standard dating from September 2001, entitled “Textiles - Monofilaments - Determination of the linear mass”.

[0055] A monofilament yarn is understood to mean any yarn comprising a single filament, and capable of being used on a textile machine, in particular a knitting machine, a weaving machine, a braiding machine.

[0056] In one embodiment, the implantable device comprises a warp knit comprising monofilament yarns, in particular: - a first monofilament yarn forms open and / or closed knitted stitches, in particular atlas stitches, more particularly extending over at least three columns of stitches (or over at least three needles), in particular over at most 20 or 15 or 10 columns of stitches (or needles); and- a second monofilament yarn forms open and / or closed knitted stitches, in particular atlas stitches, more particularly extending over at least three columns of stitches (or over at least three needles), in particular over at most 20 or 15 or 10 columns of stitches (or needles), the second yarn is supported by a guide bar working in a direction opposite to the guide bar supporting the first monofilament yarn; and

[0057] - possibly a third monofilament yarn forms open knitted stitches and / or closed, in particular atlas stitches, more particularly extending over at least three columns of stitches (or over at least three needles), in particular over at most 20 or 15 or 10 columns of stitches (or needles), in particular according to the same mesh pattern than that of the first monofilament yarn; and

[0058] - possibly a fourth monofilament thread forms knitted stitches open and / or closed, in particular atlas stitches, more particularly extending over at least three columns of stitches (or over at least three needles), in particular over at most 20 or 15 or 10 columns of stitches (or needles), the fourth thread is supported by a guide bar working in a direction opposite to the guide bar supporting the third monofilament thread.

[0059] In one embodiment, the knit comprises:

[0060] - a first monofilament thread threaded, in particular fully, onto a first bar with B1 guides according to the following weave described in accordance with ISO 11676, dating from 2014: 2- 3 / 2- 1 / 2- 3 / 2- 1 / 1- 0 / 1- 2 / 1- 0 / 1- 2 / / ;

[0061] - a second monofilament thread threaded, in particular fully, onto a second bar at B2 guides according to the following weave described in accordance with ISO 11676, dating from 2014: 1- 0 / 1- 2 / 1- 0 / 1- 2 / 2- 3 / 2- 1 / 2- 3 / 2- 1 / / ;

[0062] - and possibly:

[0063] - a third monofilament thread threaded, in particular fully, on a third B3 guide bar according to the following weave described in accordance with ISO 11676, dated 2014: 2- 3 / 2- 1 / 2- 3 / 2- 1 / 1- 0 / 1- 2 / 1- 0 / 1- 2 / / ; and / or

[0064] - a fourth monofilament thread threaded, in particular fully, on a fourth B4 guide bar according to the following weave described in accordance with ISO 11676, dated 2014: 1- 0 / 1- 2 / 1- 0 / 1- 2 / 2- 3 / 2- 1 / 2- 3 / 2- 1 II.

[0065] Preferably, bar B1 moves / knits in a direction opposite to the direction of movement / knitting of bar B2.

[0066] Preferably, bar B3 moves / knits in a direction opposite to the direction of movement / knitting of bar B4.

[0067] Preferably, the bar B1, respectively B2, moves / knits in the same direction as the direction of movement / knitting of the bar B3, respectively B4.

[0068] Advantageously, working with guide bars having the same movement makes it possible to knit with a single thread per bar, and thus to better balance the tensions exerted on a thread than if a bar supports two threads, while increasing the surface mass of the knitting.

[0069] For example, a knitted fabric with two bars B1 and B2, each bar supporting a yarn, makes it possible to obtain a surface mass of approximately 120 g / m2 at + / - 20 g / m2.

[0070] For example, a knitted fabric with four bars B1, B2, B3 and B4, each bar supporting a yarn, makes it possible to obtain a surface mass of approximately 170 g / m2 at + / - 20 g / m2.

[0071] The implantable device may comprise a textile, for example a knit, comprising one or more resorbable polymeric coating(s), for example based on polyvinylpyrrolidone, a cellulose polymer, a cyclodextrin polymer, a k-carrageenan polymer, or a combination thereof. Improved mechanical strength (N / cm)

[0072] Mechanical strength (Newtons / cm), or burst value (Newtons / cm), is measured according to the test method described in ASTM D3787-7 (2011), entitled “Bursting Strength of Textiles - Constant-Rate of Traverse (CRT) Bail Burst Test” or “Bursting Strength of Textiles - Constant-Rate of Traverse (CRT) Ball Burst Test”.

[0073] In particular, this standard makes it possible to determine a total breaking strength F expressed in newtons. The breaking strength expressed in N / cm is calculated by dividing the total breaking strength expressed in Newtons by the perimeter of the ball expressed in cm.

[0074] In particular, the diameter of the ball, in accordance with ASTM D3787-7 (2011), is 2.54 cm (i.e. “one English inch” or “international technical inch”) and therefore has a perimeter of 2.54 x Pi in cm. The breaking strength expressed in N / cm is therefore calculated according to the formula: F / (2.54 x Pi).

[0075] In particular, the tests are carried out on an average of three to six textile samples, in particular six, of approximately 10 cm * 10 cm. More particularly, the sample (10 cm x 10 cm) is firmly fixed without tension between two grooved circular plates. Then, the movable accessory, comprising a rod having one end comprising a ball, is fixed on the traction jaw and the accessory moves towards the surface of the textile sample so that the ball perforates said textile sample at a constant displacement speed of 305 mm / min. A force is exerted against the surface of the textile sample by the steel ball (the diameter of the ball is in particular one inch, or 2.54 cm). The burst value by the ball corresponds to the force necessary to pierce the sample.This value in (newtons) is divided by the circumference of the ball with a diameter of one English inch (2.54 x Pi = approximately 7.98 cm) to obtain the resistance value in newtons per centimeter (N / cm).

[0076] This test advantageously makes it possible to use the entire textile surface of the sample tested.

[0077] Advantageously, the implantable device, in particular the textile plate (flat or three-dimensional) or the knit, has a mechanical resistance or bursting value before implantation or at 0 days of hydrolysis, greater than or equal to 16 N / cm for the treatment of an inguinal hernia.

[0078] Advantageously, the implantable device, in particular the textile plate (i.e. flat or three-dimensional) or the knit, has a mechanical resistance or bursting value before implantation or at 0 days of hydrolysis, greater than or equal to 32 N / cm for the treatment of a ventral hernia.

[0079] Preferably, the implantable device, in particular the textile plate (i.e. flat or three-dimensional) or the knit, has a mechanical strength (N / cm) of RO (N / cm) before implantation or at 0 days of hydrolysis, and a mechanical strength (N / cm) RI after 3 months of hydrolysis, with RI less than or equal to 0.98 x RO or 0.93 x R0 and greater than or equal to 0.60 x R0 or 0.70 or 0.80 x R0.

[0080] Preferably, the implantable device has a mechanical strength (N / cm) of R0 (N / cm) before implantation or at 0 days of hydrolysis, and a mechanical strength (N / cm) R2 after 5 months of hydrolysis, with R2 less than or equal to 0.94 x R0 or 0.89 x R0 and greater than or equal to 0.50 x R0 or 0.60 x R0. Preferably, the implantable device has a mechanical strength (N / cm) of R0 (N / cm) before implantation or at 0 days of hydrolysis, and a mechanical strength (N / cm) R3 after 8 months of hydrolysis, with R3 less than or equal to 0.60 or 0.50 x R0 and greater than or equal to 0.20 or 0.30 or 0.35 x R0.

[0081] Preferably, the reduction in mechanical resistance observed for the implantable device treated according to the invention is between a minimum of 10% and a maximum of 27% after 3 months of hydrolysis compared to more than 30% for an implantable device of identical structure but not treated according to the invention with CO2sc.

[0082] Advantageously, the reduction in mechanical strength (N / cm) observed for the implantable device treated according to the invention with CO2sc, in particular deduced from the curve EX1 shown in the attached [Fig.4], is approximately 12% after 5 months of hydrolysis and 61% after 8 months of hydrolysis compared to 95% after 5 months of hydrolysis and 100% after 8 months of hydrolysis, in particular deduced from the curve EXC2 shown in the attached [Fig.4], for an implantable device of identical structure not treated according to the invention with CO2sc.

[0083] CO2sc, or supercritical carbon dioxide or in a supercritical state

[0084] Pure carbon dioxide enters a supercritical state when subjected to a pressure greater than a critical pressure and heated above a critical temperature, in particular according to the pressure (bars) and temperature (°C) diagram shown in the attached [Fig.l].

[0085] Advantageously, the critical pressure is greater than or equal to 73 bars, and the critical temperature is greater than or equal to 31°C.

[0086] Advantageously, carbon dioxide in a supercritical state has particular properties: comparable to those of a liquid whose density is greater than or equal to 0.2 g / cm3 and less than or equal to 1 g / cm3 with a solvent power, and comparable to those of a gas with a high diffusivity greater than or equal to 10 4 cm2 / second, and less than or equal to 103 cm2 / second, in particular is miscible with other gases, and / or has a low surface tension.

[0087] Advantageously, carbon dioxide in a supercritical state (designated above and hereinafter CO2sc) has a viscosity greater than or equal to 10 pPa.s and less than or equal to 100 pPa.s.

[0088] In one embodiment, processing step (ii) comprises the following steps, in particular taking place in the following order:

[0089] - iia) the supply of liquid carbon dioxide;

[0090] - iib) the application to carbon dioxide of temperature and pressure conditions allowing carbon dioxide to pass from a liquid state to a supercritical state;

[0091] - iic) feeding carbon dioxide in supercritical state to an enclosure, in in particular an autoclave, comprising the implantable device, in particular said enclosure comprises a sealed treatment volume in which the temperature and pressure conditions are determined so as to maintain the carbon dioxide in a supercritical state.

[0092] Advantageously, the carbon dioxide is stored in a container in the liquid state during step iia).

[0093] Advantageously, step iib) firstly comprises pumping the carbon dioxide in the liquid state and applying a determined pressure for the transformation of the carbon dioxide in the liquid state into a gaseous state, then the carbon dioxide in the gaseous state is heated to a determined temperature for the transformation of the carbon dioxide in the gaseous state into carbon dioxide in a supercritical state.

[0094] Advantageously, step iic) comprises pumping and supplying the treatment volume of the enclosure with the CO2sc.

[0095] Advantageously, after step iic), the pressure of the CO2sc is lowered, for example according to a pressure determined on the diagram of [Fig.l], to reach a gaseous state, then the gaseous CO2 obtained undergoes a separation step making it possible to separate the CO2 from any contaminant(s), the resulting gaseous CO2 is condensed to reach a liquid state, and possibly be supplied to the storage container (for example to undergo a new treatment cycle according to step ii)).

[0096] Preferably, in step ii), in particular in step iib) and / or iic), the carbon dioxide is heated, in particular maintained in step iic), at a temperature greater than or equal to 10°C, more preferably greater than or equal to 20°C, preferentially greater than or equal to 25°C or 30°C or 33°C or 35°C.

[0097] Preferably, in step ii), in particular in step iib) and / or iic), the carbon dioxide is heated, in particular maintained in step iic), at a temperature less than or equal to 100°C, more preferably less than or equal to 80°C, preferentially less than or equal to 70°C or 60°C or 55°C or 50°C.

[0098] Preferably, in step ii), in particular in step iib) and / or iic), the carbon dioxide is pressurized, in particular maintained in step iic), at a pressure greater than or equal to 50 bars, more preferably greater than or equal to 60 bars, preferentially greater than or equal to 70 bars or 80 bars or 90 bars, more preferably greater than or equal to 100 bars or 110 bars or 120 bars or 130 bars or 140 bars or 150 bars.

[0099] Preferably, in step ii), in particular in step iib) and / or iic), the carbon dioxide is pressurized, in particular maintained in step iic), at a pressure less than or equal to 600 bars, more preferably less than or equal to 500 bars, preferably less than or equal to 480 bars or 460 bars or 440 bars, more preferably less than or equal to 420 bars or 380 bars or 360 bars or 340 bars or 320 bars or 300 bars or 250 bars or 200 bars.

[0100] In one embodiment, in step ii), in particular in step iib) and / or iic), the carbon dioxide is pressurized to a pressure of between 100 bars and 300 bars and heated to a temperature of between 35°C and 50°C.

[0101] In a preferred embodiment, in step ii), in particular in step iib) and / or iic), the carbon dioxide is pressurized to a pressure of 150 bars to within + / - 20 bars, and heated to a temperature of 38°C to within + / - 5°C.

[0102] Preferably, the treatment time of the implantable device in step ii), in particular in step iic) is greater than or equal to 5 minutes, more preferably greater than or equal to 10 minutes or 15 minutes or 20 minutes, preferably greater than or equal to 25 minutes or 30 minutes.

[0103] Preferably, the treatment time of the implantable device in step ii), in particular in step iic), is less than or equal to 60 minutes, more preferably less than or equal to 50 minutes or 40 minutes or 35 minutes.

[0104] In a preferred embodiment, the treatment time of the implantable device in step ii), in particular in step iic), is about 30 minutes to + / - 5 minutes.

[0105] In a preferred embodiment, the quantity of carbon dioxide in the supercritical state supplied to the enclosure in step iic) is between 500 Kg / m3 and 1200 Kg / m3, preferably between 600 Kg / m3 and 1100 Kg / m3, more preferably between 700 Kg / m3 and 900 Kg / m3, preferentially from 800 Kg / m3 to within + / - 50 Kg / m3.

[0106] In one embodiment, the volume of CO2sc supplied to the treatment chamber corresponds to at least 20%, or at least 30% or at least 40%, preferably at least 50%, of the total treatment volume of the treatment chamber, more preferably approximately 66% to + / - 10% of the total treatment volume of the treatment chamber. Hydrolysis protocol

[0107] The hydrolysis of a textile, and in particular of the inventive implantable device or comparative, includes the following steps: - one or more samples of the implantable device, in particular one or more textile samples, each having dimensions of 10 cm x 10 cm is / are introduced into a glass container containing 10 liters of purified water then buffered with phosphate buffered saline (PBS) to obtain a pH of 7.4. The container is made of an inert material, in particular glass, and hermetically sealed with a lid thus preventing loss of water by evaporation (the volume of 10 liters therefore remains constant). This container is then introduced into an oven at a temperature of 37°C. Manual stirring is carried out every day for approximately 15 seconds in order to standardize the hydrolysis medium. In particular, between each manual stirring, no additional mechanical stirring is carried out.

[0108] The sample whose mechanical resistance is to be analyzed after a period of n months, or n*4 weeks, of hydrolysis is extracted from the container, then dried, in particular in an oven at 37°C for 60 minutes. The hydrolysis time thus corresponds to the time during which the sample remained in the volume of PBS and placed in an oven at 37°C.

[0109] In this text, n months means a duration equivalent in weeks to n * 4, n being an integer.

[0110] In an alternative embodiment, at least 80% by mass, preferably at least 85% or at least 87% or at least 89% or at least 91% or at least 93% or at least 95% or at least 97% or at least 99% or about 100% by mass, of the total mass of the implantable device provided in step i) is resorbable, in particular bioresorbable.

[0111] Preferably, at least 85% or at least 87% or at least 89% or at least 91% or at least 93% or at least 95% or at least 97% or at least 99% or about 100% by mass, of the total mass of the implantable device and / or of a textile (which the implantable device comprises) provided in step i) is formed from one or more (co)polymer(s) chosen from: - a polymer of lactic acid of L or D form or of L and D forms, of one or more polymer(s) of glycolic acid, of one or more copolymer(s) of lactic acid (L and / or D) and glycolic acid, or a mixture thereof, preferably of one or more polymer(s) of lactic acid of L or D form or of L and D forms (list I); and / or - is formed from one or more monofilament(s) each comprising one or more (co)polymer(s) chosen from list I above.

[0112] In an alternative embodiment, said method comprises a step iv) of sterilization of the implantable device carried out after step iii), in particular comprising the application of ethylene oxide to said implantable device.

[0113] Advantageously, any sterilization method known to those skilled in the art can be used.

[0114] In an alternative embodiment, the implantable device of step iii) has a mechanical strength, or burst value (Newtons / cm), greater than or equal to 10 N / cm after 32 weeks or 8 months of hydrolysis, in particular in an aqueous medium buffered with a phosphate saline solution at a pH of 7.4 and maintained at a temperature of 37°C in a hermetically sealed environment.

[0115] In an alternative embodiment, the temperature of the supercritical CO2 during step ii), in particular during step iib) and / or iic), is less than or equal to 70°C, in particular greater than or equal to 10°C.

[0116] In an alternative embodiment, treatment step ii), in particular during step iib) and / or iic), comprises the application of supercritical CO2 at a pressure greater than or equal to 50 bars, in particular less than or equal to 400 bars.

[0117] Advantageously, the temperature and pressure applied do not modify the mechanical properties of the implantable device.

[0118] In an alternative embodiment, treatment step ii), in particular during step iib) and / or step iic), comprises the application of supercritical CO2 at a pressure greater than or equal to 100 bars.

[0119] In an alternative embodiment, the implantable device provided in step i) comprises one or more monofilament threads each comprising at least one lactic acid (co)polymer, in particular a lactic acid polymer of L-form or D-form, or a combination thereof.

[0120] In an alternative embodiment, said monofilament thread(s) each comprising at least one lactic acid (co)polymer has, or each has, a diameter greater than or equal to 50 μm (i.e. 0.050 mm) and less than or equal to 500 μm (i.e. 0.50 mm), in particular less than or equal to 300 μm (i.e. 0.30 mm).

[0121] In an alternative embodiment, said at least one lactic acid (co)polymer has a glass transition temperature (Tg) greater than or equal to 40°C and less than or equal to 150°C.

[0122] Preferably, said at least one lactic acid (co)polymer has a glass transition temperature (Tg) greater than or equal to 50°C, more preferably greater than or equal to 60°C, preferentially greater than or equal to 70°C, even more preferentially greater than or equal to 80°C.

[0123] Preferably, said at least one lactic acid (co)polymer has a glass transition temperature (Tg) less than or equal to 120°C, more preferably less than or equal to 110°C, preferentially less than or equal to 100°C, even more preferentially less than or equal to 95°C.

[0124] In an alternative embodiment, said at least one lactic acid (co)polymer has a melting temperature (Tf) greater than or equal to 130°C and less than or equal to 210°C.

[0125] Preferably, said at least one lactic acid (co)polymer has a melting temperature (Tf) greater than or equal to 140°C, more preferably greater than or equal to 150°C, preferentially greater than or equal to 160°C, more preferably greater than or equal to 165°C.

[0126] Preferably, said at least one lactic acid (co)polymer has a melting temperature (Tf) less than or equal to 200°C, more preferably less than or equal to 190°C, preferentially less than or equal to 180°C.

[0127] Preferably, said at least one lactic acid (co)polymer has a crystallinity rate greater than or equal to 30%, or 40% or 45%, more preferably greater than or equal to 50% or 53%.

[0128] Preferably, said at least one lactic acid (co)polymer has a crystallinity rate less than or equal to 80%, or 70% or 65%, more preferably less than or equal to 60%.

[0129] Advantageously, the term “crystallinity rate” is understood to mean the ratio of the total sum in volume or mass of the crystalline fractions of a given sample relative to the total mass or volume of said sample.

[0130] Advantageously, the glass transition temperature, the melting temperature, and the crystallinity rate are determined on the monofilament yarn comprising said lactic acid (co)polymer.

[0131] Preferably, the melting and glass transition temperatures, and the degree of crystallinity, are measured using the following standards: ISO 11357-2 (2013) entitled “Determination of the glass transition temperature and the glass transition step height”, ISO 11357-3 (2018) entitled “Determination of the temperature and enthalpy of melting and crystallization.

[0132] The apparatus is a power-compensated DSC, DSC Q2000 (TA Instruments). The operating conditions are as follows: the apparatus mode is standard, the sample-holding crucibles are made of hermetic aluminum, the sweep gas is U-grade nitrogen (50 ml / min), the temperature ramp is isothermal at 25°C for 5 minutes, then increases from 25°C to 250°C with a gradient of 10°C per minute. The test pieces are kept for two hours at room temperature (23°C) and 50% relative humidity to within + / - 10%.

[0133] In an alternative embodiment, said at least one lactic acid (co)polymer has a weight-average molar mass Mw greater than or equal to 70,000 g / mol and less than or equal to 300,000 g / mol.

[0134] Preferably, said at least one lactic acid (co)polymer has a weight-average molar mass Mw greater than or equal to 80,000 g / mol, or 90,000 g / mol, or 100,000 g / mole, more preferably greater than or equal to 110,000 g / mole, or 120,000 g / mole, or 130,000 g / mole, or 140,000 g / mole, or 145,000 g / mole.

[0135] Preferably, said at least one lactic acid (co)polymer has a weight-average molar mass Mw of less than or equal to 250,000 g / mol, or 230,000 g / mol, or 210,000 g / mol, more preferably less than or equal to 200,000 g / mol, or 190,000 g / mol, or 180,000 g / mol, or 170,000 g / mol, or 160,000 g / mol.

[0136] In an alternative embodiment, said at least one lactic acid (co)polymer has a number-average molar mass Mn greater than or equal to 10,000 g / mole and less than or equal to 120,000 g / mole or 110,000 g / mole.

[0137] Preferably, said at least one lactic acid (co)polymer has a number-average molar mass Mn greater than or equal to 20,000 g / mol, or 30,000 g / mol, more preferably greater than or equal to 40,000 g / mol, or 45,000 g / mol.

[0138] Preferably, said at least one lactic acid (co)polymer has a number-average molar mass Mn of less than or equal to 90,000 g / mol, or 80,000 g / mol, more preferably less than or equal to 70,000 g / mol, or 60,000 g / mol.

[0139] In an alternative embodiment, said at least one lactic acid (co)polymer has a polydispersity Ip (Mw / Mn) greater than or equal to 1.5 or 2 and less than or equal to 5, preferably less than or equal to 4, more preferably less than or equal to 3.5 or 3.

[0140] Advantageously, the weight and number average molar masses (g / mol) are determined on the monofilament yarn comprising said lactic acid (co)polymer.

[0141] Preferably, the number and weight average molar masses are measured using ASTM D3536-91 entitled "Standard Test Method for Weight Average Molecular Weights and Their Distribution by Liquid Size Exclusion Chromatography (Gel Permeation Chromatography- GPC)." This technique is also referred to as size exclusion chromatography.

[0142] Preferably, the operating conditions are as follows: Agilent 1260 Infinity GPC systems, Waters Styragel 4-column system, 300*4.6 mm, 5 μm particles, porosity of 50 to 104 A, thermostatically controlled at 40°C, an analysis-grade THF eluent filtered with a flow rate of 0.5 ml / min, pre-filtration of the samples on a 0.2 μm PTFE filter, dual RI and UV detection (254 nm), polystyrene calibration, sample preparation by dissolution in a tetrahydrofuran (THF) / Toluene mixture (used as a marker).

[0143] In an alternative embodiment, said at least one lactic acid (co)polymer comprises L-form lactic acid units and D-form lactic acid units.

[0144] Advantageously, the shapes L and D as well as their proportions are determined on the monofilament yarn comprising said lactic acid (co)polymer.

[0145] Preferably, to determine the optical rotation, the samples to be tested are dissolved in chloroform at a concentration of 1g / dl.

[0146] Preferably, the D or L form monomer is measured by gas chromatography coupled with mass spectrometry.

[0147] Preferably, the operating conditions are as follows: each sample is extracted in dichloromethane, the polymer is precipitated in hexane, and the mixture is filtered on a 0.2 pm PTFE syringe filter, the dosage is carried out by external calibration (lactide monomer form D or L) using four standards prepared at different concentrations; the chromatographic conditions are preferably as follows: Agilent HP5975C spectrometer, Agilent 7890 GC, HP-5MS column (5% polyphenyl-silowane) 30m, thickness 0.25 pm, diameter 0.25 mm, isotherm of 1 min at 50°C then heating at 25°C / min from 50°C to 320°C, isotherm of 5 min at 320°C, the injector is heated to 200°C, injection of 2pl in splitless mode, detection in SCAN mode.

[0148] In an alternative embodiment, said at least one lactic acid (co)polymer comprises at least 80% by mass of L-form lactic acid units and less than 20% by mass of D-form lactic acid units.

[0149] Preferably, said at least one lactic acid (co)polymer comprises at least 85% or 88% or 90% or 92% or 94% or 96% or 98% by mass of L-form lactic acid units.

[0150] Preferably, said at least one lactic acid (co)polymer comprises at most 15% or at most 10% or at most 8% or at most 6% by mass of D-form lactic acid units, more preferably at most 5% or 4% by mass of D-form lactic acid units.

[0151] Preferably, said at least one lactic acid (co)polymer comprises at least 0.5% or 1% or 1.5% by mass of D-form lactic acid units.

[0152] In an alternative embodiment, at least 80%, preferably at least 85% or 90% or 95%, by mass of the implantable device comprises one or more monofilament thread(s) in one or more lactic acid (co)polymer(s).

[0153] The improvement in mechanical resistance, or burst value, to hydrolysis is significant from 3 months of hydrolysis for an implantable device comprising monofilament threads made of lactic acid (co)polymer, knitted with warp stitches, and in particular with a lactic acid polymer as described above.

[0154] In an alternative embodiment, said method comprises a step of heat-fixing the textile(s) (which the implantable device comprises) or the implantable device, preferably taking place before step ii) or after step ii).

[0155] Preferably, said heat-setting step comprises the application of a temperature greater than or equal to 80°C and less than or equal to 130°C, still preferably greater than or equal to 90°C and less than or equal to 120°C, preferably from 110°C to + / - 5°C.

[0156] Preferably, the duration of said heat-setting step is greater than or equal to 30 seconds, more preferably greater than or equal to 60 seconds, preferably approximately 120 seconds to + / - 30 seconds.

[0157] Preferably, the duration of said heat-setting step is less than or equal to 2 hours, more preferably less than or equal to 1 hour, preferably less than or equal to 30 min or 20 min or 10 min or 5 min.

[0158] Preferably, no tensile force is exerted on the knit(s) or the implantable device during the heat-setting step, in particular the knit(s) or the device is / are free of tension.

[0159] The subject of the present invention, according to a second aspect, is an implantable device for the treatment of an abdominal hernia, in particular ventral or inguinal, capable of being obtained by the method according to any one of the variant embodiments with reference to the first aspect of the invention and / or as described in the present text.

[0160] Advantageously, the implantable device obtained has an improved mechanical resistance or burst value after three to eight months of hydrolysis compared to a similar device not treated with sc CO2.

[0161] In an alternative embodiment, at least 80% by mass, preferably at least 85% or 90% or 95% or 98% by mass, of the implantable device is formed from one or more monofilament thread(s) in one or more lactic acid (co)polymer(s), and the implantable device has a mechanical strength greater than or equal to 10N / cm, preferably greater than or equal to 15N / cm or 20N / cm, more preferably 25N / cm, after 20 weeks of hydrolysis.

[0162] The variants and definitions according to the first aspect of the invention apply independently of each other to the implantable device according to a second aspect of the invention.

[0163] The subject of the present invention, according to a third aspect, is the use of supercritical CO2 to improve the mechanical strength (N / cm), or burst value (N / cm), of an implantable device comprising one or more wires comprising at least one lactic acid (co)polymer at the end of a determined hydrolysis period, in particular in a determined aqueous medium, in particular at the end of a period of at least 20 weeks to obtain a mechanical strength greater than or equal to 10 N / cm, preferably greater than or equal to 15 N / cm or 20 N / cm, more preferably greater than or equal to 25 N / cm.

[0164] In particular, said use comprises the application of supercritical CO2 to said implantable device and / or to said monofilament wire(s).

[0165] The variants and definitions according to the first aspect of the invention and / or the second aspect of the invention apply independently of each other to the third aspect of the invention.

[0166] The present text also comprises, according to a fourth aspect, a method of using an implantable device comprising:

[0167] - implementing the method to induce an improvement in resistance mechanical strength of an implantable device comprising one or more wire(s) comprising (each) one or more lactic acid (co)polymer(s) according to any one of the embodiment variants with reference to the first aspect of the invention, or the provision of an implantable device according to a second aspect of the invention or obtainable by said method to induce an improvement in the mechanical strength according to any one of the embodiment variants with reference to the first aspect of the invention, and

[0168] - the selection of a group of patients chosen from the following groups: patients having a BMI greater than or equal to 30, patients suffering from type I and / or II diabetes, patients who are smokers (or suffer from smoking), and patients chosen from a combination of said patient groups;

[0169] - treatment of the patient group selected for treatment of ab hernia dominal, in particular ventral or inguinal, with said implantable device.

[0170] BMI is the acronym for “Body Mass Index” calculated by dividing weight (Kg) by height (cm) squared. Description of the drawings

[0171] The present invention will be better understood by reading the following embodiments, cited without limitation, and illustrated by the figures in which:

[0172] [Fig-1] [Fig.l] schematically represents the different states (solid, liquid, gaseous, supercritical) of carbon dioxide as a function of pressure (bars) on the ordinate and temperature (°C) on the abscissa;

[0173] [Fig.2] [Fig.2] is a table showing the mechanical resistance values ​​(value ball bursting) for an example according to the invention (EX1) and two comparative examples (EXC1, EXC2) without hydrolysis and for different hydrolysis periods: 1 month, 2 months, 3 months, 5 months, and 8 months;

[0174] [Fig.3] [Fig.3] is a table showing the mechanical resistances (values residual ball burst strength) measured by relating the mechanical strength at T 1,2,3,5, or 8 months to the initial mechanical strength T0 multiplied by 100, said mechanical strengths being indicated in [Fig.2];

[0175] [Fig.4] [Fig.4] is a graph representing the burst values ​​on the ordinate residual ball (%) on the ordinate as a function of the hydrolysis duration on the abscissa of several examples of implantable devices according to the invention and of comparative examples of implantable devices;

[0176] [Fig.5] [Fig.5] is a graph representing on the ordinate the ball burst values ​​(N / cm) on the ordinate as a function of the hydrolysis time on the abscissa of several examples of implantable devices according to the invention and of comparative examples of implantable devices;

[0177] [Fig.6] [Fig.6] represents the mesh diagram of the first example of implantable device according to the invention and comparative examples of implantable device. Description of the embodiments

[0178] The diagram in [Fig.l] represents the different states: solid, liquid, gaseous and supercritical of carbon dioxide according to the pressure (bars) and temperature conditions applied to it.

[0179] Thus, we observe a so-called triple point at -56°C and 5.18 bars at the intersection of which we observe the boundaries between the solid, liquid and gaseous states.

[0180] The critical point from which carbon dioxide is in a supercritical state comprises a temperature greater than or equal to 31°C combined with a pressure greater than or equal to 73.85 bars. It is observed that in this supercritical state, carbon dioxide is both in conditions close to the liquid state which allows it to behave like a solvent, in conditions between a gas and a liquid which allows it to impregnate the implantable device and in conditions close to the gaseous state which would allow it to diffuse into the structure of the monofilament threads based on lactic acid. The Applicant has surprisingly observed that treatment with CO2sc, in particular of the textile structure of the implantable device, makes it possible to significantly improve the mechanical resistance of the implantable device during its hydrolysis.

[0181] Advantageously, the treatment with CO2sc according to the invention makes it possible to improve the mechanical behavior of the implantable device during hydrolysis, in particular to reduce the rate of hydrolysis, but is not a treatment for its sterilization. In one embodiment, a sterilization step, distinct from the step of treatment with CO2sc to induce an improvement in the mechanical resistance, is necessary. This sterilization step can be carried out by any sterilization method known in the technical field for sterilizing an implantable device, in particular already placed in a double bag.

[0182] Figures 2 to 5 represent the results of the hydrolysis tests obtained for an example EX1 of embodiment according to the invention, and two comparative examples EXC1 and EXC2.

[0183] Example EX1 is a 10 gauge yarn over knit knitted according to the stitch pattern re shown in [Fig.6]. This knit comprises a first monofilament yarn 20 in a lactic acid polymer having a diameter of 0.15 mm and a linear mass of 220 dtex, and a second monofilament yarn 30 similar to the first monofilament yarn (in a lactic acid polymer having a diameter of 0.15 mm and a linear mass of 220 dtex). The first yarn 20 is supported by a first guide bar B1 on the knitting machine whose movement is as follows: 2- 3 / 2- 1 / 2- 3 / 2-1 / 1- 0 / 1- 2 / 1- 0 / 1- 2 / / .

[0184] The second yarn 30 is supported by a second guide bar B2 on the knitting machine whose movement is as follows: 1-0 / 1-2 / 1-0 / 1-2 / 2-3 / 2- 1 / 2- 3 / 2- 1 / / .

[0185] The knit 10 has a surface mass of approximately 120 g / m2, and is completely resorbable.

[0186] The first and second guide bars, or so-called guide bars, B1, B2 work / knit across the entire width of the knitting 10 and across its entire height.

[0187] Advantageously, the first and second guide bars B1, B2 work in opposition: the first guide bar supporting the wire 20 works in the direction F2 when the second guide bar supporting the wire 30 works in the direction F1, the directions F1 and F2 being opposite as shown in [Fig.6]. In this specific example, the knit 10 undergoes a heat-setting step at 110°C for 2 min, then undergoes a CO2sc treatment consisting of placing it in an autoclave at 38°C, under a pressure of 150 bars for 30 min in order to maintain the CO2 in its supercritical state. The volume of CO2sc supplied to the treatment chamber represents approximately 66% of the total treatment volume of the chamber.

[0188] Comparative examples EXC1 and EXC2 are each in a knit identical to knit 10 but do not undergo any CO2sc treatment. EXC2 undergoes a heat-setting step at 110°C for 2 minutes similar to the heat-setting step of EX1 while EXCl does not undergo a heat-setting step.

[0189] To carry out the hydrolysis tests: 30 10cm * 10cm knitted samples are introduced into a stainless steel container containing PBS-buffered water from each example (EX1, EXC1, EXC2) according to the hydrolysis protocol described above. At the end of each targeted hydrolysis period (1 month, 2 months, 3 months, 5 months, 8 months), 18 samples (6 samples from each example) are removed from the stainless steel container and then dried in an oven at 37°C for one hour. These 18 samples are all evaluated in the burst value test described above (ASTM D3787-7 (2011)) immediately after drying.

[0190] The mechanical resistance evaluated here is advantageously a ball burst value. It could be another mechanical resistance value, such as the breaking load in the warp or weft direction of the knit, i.e. any measurement making it possible to evaluate the improvement in the mechanical resistance of the knit.

[0191] The melting temperature and the crystallinity rate measured for EXl at T0 are res- respectively 169.53°C and 59%, and are at Tl (months) 167.88°C and 46%.

[0192] The melting temperature and the crystallinity rate measured for EXCl at T0 are respectively 166.76°C and 56%, and are at Tl (months) 166.83°C and 56%.

[0193] Surprisingly, it is already observed in Figures 4 and 5 that after 2 months of hydrolysis, the mechanical strength of the EX1 according to the invention is degraded but remains at more than 80% of the initial mechanical strength, whereas those of the examples EXC1 and EXC2 begin to decrease significantly. After three months and up to approximately 5 months, the mechanical strength is still at least more than 80% of the initial mechanical strength for the EX1, whereas it falls by more than 40% at three months and to more than 75% at 5 months of the initial strength for the examples EXC1 and EXC2. Finally, after 8 months of hydrolysis, the knit according to the EX1 still has a mechanical strength corresponding to approximately 40% of its initial strength, whereas the knits of the examples EXC1 and EXC2 are completely hydrolyzed or too hydrolyzed for a strength value to be measured.

[0194] The use of CO2sc to improve the mechanical strength of a textile comprising monofilaments in a lactic acid (co)polymer makes it possible to improve the hydrolysis behavior of the latter, in particular to reduce its hydrolysis rate, in a simple and reliable manner from a reliable resorbable textile structure in the treatment of a hernia for example. This arrangement will thus make it possible to prolong the mechanical reinforcement provided by the implantable device, while limiting the risks of infection, and will avoid resorting to surgery to remove the implantable device in the event of infection since the device will eventually be completely reabsorbed.

Claims

Claims

1. Method for inducing an improvement in the mechanical strength (N / cm) of an implantable device (10) after a determined period of hydrolysis of said implantable device (10), said implantable device (10) comprising one or more threads (20, 30) comprising at least one lactic acid (co)polymer, said method comprising: i)- a step of providing an implantable device (10) comprising one or more threads (20, 30) comprising at least one lactic acid (co)polymer; ii)- a step of treating said implantable device with supercritical carbon dioxide (CO2); iii)- a step of obtaining an implantable device (10) having a mechanical strength greater than or equal to 10 N / cm, preferably greater than or equal to 25 N / cm, after 20 weeks of hydrolysis, in particular in an aqueous medium.

2. A method according to claim 1, characterized in that at least 80% by mass of the total mass of the implantable device (10) provided in step i) is resorbable.

3. Method according to either of claims 1 and 2, characterized in that it comprises a step iv) of sterilization of the implantable device (10) carried out after step iii), in particular comprising the application of ethylene oxide to said implantable device (10).

4. Method according to any one of claims 1 to 3, characterized in that the implantable device (10) of step iii) has a mechanical resistance greater than or equal to 10 N / cm after 32 weeks of hydrolysis in an aqueous medium.

5. Method according to any one of claims 1 to 4, characterized in that the temperature of the supercritical CO2 during step ii) is less than or equal to 70°C, in particular greater than or equal to 10°C.

6. Method according to any one of claims 1 to 5, characterized in that the treatment step ii) comprises the application of supercritical CO2 at a pressure greater than or equal to 10 bars, in particular less than or equal to 500 bars.

7. Method according to any one of claims 1 to 6, characterized in that the treatment step ii) comprises the application of supercritical CO2 at a pressure greater than or equal to 100 bars.

8. Method according to any one of claims 1 to 7, characterized in that the implantable device (10) provided in step i) comprises one or more monofilament thread(s) (20,30) each comprising at least one lactic acid (co)polymer.

9. Method according to claim 8, characterized in that said monofilament thread(s) (20, 30) each comprising at least one lactic acid (co)polymer has, or each has, a diameter greater than or equal to 50 pm and less than or equal to 500 pm, in particular less than or equal to 300 pm.

10. Method according to any one of claims 1 to 9, characterized in that said at least one lactic acid (co)polymer has a glass transition temperature (Tg) greater than or equal to 40°C and less than or equal to 150°C.

11. Process according to any one of claims 1 to 10, characterized in that said at least one lactic acid (co)polymer has a melting temperature (Tf) greater than or equal to 130°C and less than or equal to 210°C.

12. Method according to any one of claims 1 to 11, characterized in that said at least one lactic acid (co)polymer has a weight-average molar mass Mw greater than or equal to 70,000 g / mol and less than or equal to 300,000 g / mol.

13. Method according to any one of claims 1 to 12, characterized in that said at least one lactic acid (co)polymer has a polydispersity Ip (Mw / Mn) greater than or equal to 1.5 and less than or equal to 5

14. J. Method according to any one of claims 1 to 13, characterized in that said at least one lactic acid (co)polymer comprises L-form lactic acid units and D-form lactic acid units.

15. A method according to any one of claims 1 to 14, characterized in that said at least one lactic acid (co)polymer comprises at least 80% by mass of L-form lactic acid units and less than 20% by mass of D-form lactic acid units.

16. Method according to any one of claims 1 to 15, characterized in that at least 80% by mass of the implantable device (10) comprises one or more monofilament thread(s) (20, 30) in one or more lactic acid (co)polymer(s).

17. An implantable device for treating an abdominal hernia (10) obtainable by the method according to any one of the re- claims 1 to 16.

18. Implantable device (10) according to claim 17, characterized in that it comprises at least 80% by mass of one or more monofilament thread(s) (20, 30) in one or more lactic acid (co)polymer(s), and in that the implantable device (10) has a mechanical resistance greater than or equal to 25 N / cm after 20 weeks of hydrolysis.

19. Use of supercritical CO2 to improve the mechanical strength (N / cm) of an implantable device (10) comprising one or more wires (20, 30) comprising at least one lactic acid (co)polymer at the end of a determined hydrolysis period, in particular at the end of a hydrolysis period of at least 20 weeks to obtain a mechanical strength greater than or equal to 10 N / cm, in particular greater than or equal to 25 N / cm.

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