IMPLANTABLE DEVICE, ESPECIALLY FOR THE RECONSTRUCTION OF THE ABDOMINAL WALL

Abstract

The present invention relates to an implantable device, in particular for wall repair comprising a reinforcing textile implant having first and second surfaces, a bioadhesive coating to coat said first surface at least in part, said coating comprising at least one ionic, cross-linked bioadhesive polymer selected from among the following polymers: an acrylic acid polymer, methacrylic acid polymer, itaconic acid polymer, maleic acid polymer or maleic anhydride polymer having an adhesive function that can be activated in an aqueous medium.

Claims

1-11. (canceled)

12. An implantable device, comprising: a reinforcing textile implant having first and second surfaces; a bioadhesive coating coating at least in part said first surface, said bioadhesive coating comprising at least one ionic, cross-linked bioadhesive polymer selected from among the following polymers: an acrylic acid polymer, a methacrylic acid polymer, an itaconic acid polymer, a maleic acid polymer and a maleic anhydride polymer, the ionic, cross-linked bioadhesive polymer having an adhesive function that can be activated in an aqueous medium.

13. The implantable device according to claim 12, wherein the polymer is cross-linked by a cross-linking agent selected from among a sugar polyalkenyl polyether, a polyalcohol polyalkenyl polyether and a divinyl glycol.

14. The implantable device according to claim 13, wherein the cross-linking agent is selected from among a sucrose allyl ether and an allyl, diallyl, triallyl or tetraallyl pentaerythritol.

15. The implantable device according to claim 12, wherein the bioadhesive polymer is a carbomer.

16. The implantable device according to claim 12, wherein the bioadhesive coating is obtained after the polymerisation of a composition comprising at least one monomer selected from among: acrylic acid, methacrylic acid, itaconic acid, maleic acid anhydride, and a maleic anhydride, and a cross-linking agent, the weight proportion of said cross-linking agent relative to the total weight of monomer(s) is higher than 0% and lower than or equal to 4%.

17. The implantable device according to claim 12, wherein the polymer is dehydrated and capable of forming a gel in an aqueous medium.

18. The implantable device according to claim 12, wherein the Brookfield viscosity of the bioadhesive polymer at 25 C., dispersed at 0.5 weight % in demineralised water, at a pH of between 6 and 8, is higher than 4,000 cPoises.

19. The implantable device according to claim 12, wherein the mass per unit area (g/m.sup.2) of the coating is higher than or equal to the mass per unit area of the textile implant (g/m.sup.2).

20. The implantable device according to claim 12, wherein the coating comprises a plasticizer.

21. The implantable device according to claim 12, wherein the textile implant comprises at least one monofilament thread, having a diameter greater than or equal to 0.10 mm and smaller than or equal to 0.60 mm.

22. The implantable device according to claim 18, wherein the Brookfield viscosity of the bioadhesive polymer at 25 C., dispersed at 0.5 weight % in demineralised water, at a pH of between 6 and 8, is lower than 11,000 cPoises.

23. The implantable device according to claim 20, wherein the coating comprises a polyalcohol plasticizer.

24. The implantable device according to claim 21 wherein the textile implant comprises at least one monofilament thread of polypropylene.

25. A device comprising a sterilisation pouch comprising the implantable device according to claim 12.

26. A device according to claim 25 wherein the textile implant is in a planar configuration.

Description

IVDESCRIPTION OF FIGURE 1

[0110] FIG. 1, appended hereto, illustrates three curves of adhesion forces F.sub.A and F.sub.B measured for textile implant (A) and the implantable devices (B) and (C) in accordance with protocols I and II performed on a porcine model. The first points measured at 2 min correspond to adhesion force F.sub.A, the points measured 2 min after implantation correspond to adhesion forces F.sub.B.

VTEST RESULTS

[0111] According to the three curves illustrated FIG. 1, it is observed that for a implantation time of less than 8h00 (480 min), the adhesion forces of implant (A) and of devices (B) and (C) are less than 3 Newtons. For an implantation time of more than 480 min, healing is observed giving way to cell ingrowth of the prosthesis, hence a very distinct increase in the adhesion forces obtained. With the onset of the acute inflammatory reaction, that is exudative and then cellular, the tissue adhesion of textile implant (A) and of devices (B) and (C) increases considerably and linear fashion on and after this moment.

[0112] Advantageously, it is observed that the adhesion force of the implantable device (C) is stable and within the range of [2.5; 2.9] Newtons for an implantation time of less than 480 min despite intraoperative repositioning. After 480 min, adhesion is ensured by the phenomena of cellular ingrowth of the textile implant (A) or of the implantable devices (B) and (C) and shows a major, linear increase.

Table 1 summaries the values F.sub.A and F.sub.B obtained for textile implant (A) and implantable devices (B) and (C) derived from FIG. 1.

TABLE-US-00001 TABLE 1 Implantation Implantable Implantable time (in minutes) Textile implant (A) device (B) device (C) 2 0.0 N 2.6 N 2.7 N 120 0.0 N 1.0 N 2.6 N 240 0.0 N 0.5 N 2.8 N 360 0.0 N 0.5 N 2.5 N 480 3.0 N 3.3 N 2.9 N 1020 16.6 N 16.8 N 17.0 N 1440 26.0 N 26.5 N 27.4 N