FR2899789A1 - Device for protection of nerve and/or sinew located in a canal zone of human body closed by a ligament, comprises a plate having a convex first side as adherence surface and a concave second side as gliding surface, and a medicinal layer - Google Patents

Abstract

The device for protection of nerve and/or sinew located in a canal zone of human body closed by a ligament, comprises a plate (10) having a convex first side as adherence surface (10e) and a concave second side as gliding surface (10f), and a medicinal layer (Cm). The human body is opened during surgical intervention. The medicinal layer totally or partially overlay on the first and second sides of the plate. The plate is covered on a first two parallel sides of rectilinear sections and a second two parallel sides of curvilinear sections, and is covered with medicinal layer. The device for protection of nerve and/or sinew located in a canal zone of human body closed by a ligament, comprises a plate (10) having a convex first side as adherence surface (10e) and a concave second side as gliding surface (10f), and a medicinal layer (Cm). The human body is opened during surgical intervention. The medicinal layer totally or partially overlay on the first and second sides of the plate. The plate is covered on a first two parallel sides of rectilinear sections and a second two parallel sides of curvilinear sections, and is covered with medicinal layer, which constitutes different active medicinal principles and has different thickness to determine resorption time. The plate is totally or partially covered with an inert layer between each medicinal layers to protect or move within to the resorption time of the medicinal layer. The medicinal layer is constituted by two partial medicinal layers, which is arranged with different dimensions, and is constituted by active principle belongs to anti-fibrous, antimitotic, analgesic, local anasthetic and anti-inflammatory agents. The two partial medicinal layers are constituted by different active medicinal principles. The medicinal layer covering the gliding surface of the plate is constituted by active principle belongs to medicaments and anti-adherence agents.

Description

NERVE PROTECTION DEVICE COVERED WITH AT LEAST ONE LAYER

  The present invention relates to a device for protecting the nerves covered on at least one of its faces with at least one drug layer or at least one active medicinal ingredient. It is known from European Patent No. 1229866 belonging to the applicant a device for protecting the nerves and / or tendons, located in any ductal zone of the human body, normally closed by a ligament and which was opened during a surgical procedure. , said device comprising at least one rigid or semi-rigid plate, intended to be inserted between the cut edges of said ligament, after cutting performed during said surgical procedure, and one of which has a sliding surface and the other side a adhesion surface.

  The object of the present invention is to improve the protective device of the nerves and / or tendons described in European Patent No. 1229866 belonging to the applicant, to reduce, for example, the risk of pain, inflammation, or fibrosis due to the implantation of said device for protecting the nerves between the cut edges of the ligament, due especially to the natural healing sometimes excessive.

  Also, the object of the present invention is to obtain a pharmacologically active device for improving the results of surgical procedures. The device for protecting the nerves and / or tendons according to the present invention comprises at least one plate comprising on the one hand a first face, said adhesion surface, and a second face called a sliding surface, and on the other hand at least one medicament layer completely or partially covering at least one of said first and second faces.

  The device for protecting the nerves and / or tendons according to the present invention comprises a plate which has a curved or curved profile delimiting a first concave face, said adhesion surface, and a second convex face 40 called a sliding surface, one of which less is totally or partially covered with at least one drug layer.

  The device for protecting the nerves and / or tendons according to the present invention comprises a plate which is covered on the first two parallel sides 45 of rectilinear profiles and / or on the second two parallel sides of curvilinear profiles of at least one drug layer. .5 The nerve and / or tendon protection device according to the present invention comprises a plate which is covered with drug layers each consisting of a different drug active ingredient.

  The nerve and / or tendon protection device according to the present invention comprises a plate which is covered with drug layers having a different thickness to determine a resorption time as a function of the processing time.

  The device for protecting the nerves and / or tendons according to the present invention comprises a plate whose last medicinal layer is totally or partially covered with an inert layer for protecting and shifting the resorption of said drug layer over time.

  The nerve and / or tendon protection device according to the present invention comprises a plate which has an inert layer between each drug layer.

  The nerve and / or tendon protection device according to the present invention comprises a drug layer which consists of at least two partial drug layers arranged next to one another.

  The nerve and / or tendon protection device according to the present invention comprises partial drug layers which may consist of different active ingredients.

  The device for protecting the nerves and / or tendons according to the present invention comprises a drug layer which consists of an active ingredient whose components belong to the family of anti-fibrous agents. The nerve and / or tendon protection device according to the present invention comprises a drug layer which consists of an active ingredient whose components belong to the anti-cancer family, in particular anti-mitotic drugs. The nerve and / or tendon protection device according to the present invention comprises a drug layer which consists of an active ingredient whose components belong to the family of analgesics.

  The nerve and / or tendon protection device according to the present invention comprises a drug layer which consists of an active ingredient whose components belong to the family of local anesthetics.

  The protective device for nerves and / or tendons according to the present invention, 45 comprises a drug layer which consists of an active ingredient whose components belong to the family of anti-inflammatories.

  The device for protecting the nerves and / or tendons according to the present invention comprises a drug layer covering the face forming the sliding surface of the plate which consists of an active ingredient belonging to the family of drugs or anti-aging components. adhesion.

  The following description with reference to the accompanying drawings, given by way of non-limiting examples, will provide a better understanding of the invention, the characteristics it has and the advantages that it is likely to provide:

  Figure 1 is an exploded perspective view illustrating the nerve and / or tendon protector provided with the drug layers of the present invention.

  Figure 2 is a partial sectional view showing the establishment of the protective device of the nerves and / or tendons according to the invention.

  FIGS. 1 and 2 show a device for protecting the nerves and / or tendons 1, which consists of a rigid or semi-rigid plate 10 of rectangular shape, which maintains optimum continuity in the shape of the ligament and increases the volume of the ligament. carpal tunnel.

  To allow the insertion of the plate 10 between the cut edges 21 of the ligament 2 after cutting, the plate 10 must advantageously have a shape and dimensions adapted respectively to the implantation site, that is to say, to the shape of the canal area and the cut made. In particular, the dimensions of the plate 10 must allow its insertion between the cut edges 21 of the ligament 2. Preferably, the length and the width correspond with the opening 20 of the ligament and in particular the distance separating said edges 21 after cutting, the length of the plate 10 therefore being at most equal to that of the opening 20.

  For a protection more particularly adapted to the ductal zone of the wrist, the plate 10 is of curved or curved shape, that is to say, in the form of a cylindrical cap with two first parallel sides 10a, 10b of rectilinear profiles in the longitudinal direction corresponding to the cut edges 21 of the ligament 2, and two second parallel sides 10c, 10d of curvilinear profiles in the transverse direction.

  The plate 10 of curved or curved shape has between its first and second 40 parallel sides 10a, 10121 10p, 10d a first convex face 10e said adhesion surface and a second concave face 10f said sliding surface.

  "Adhesion surface" means a surface having a texture and / or a roughness, in particular a porosity, so as to promote the re-habitation of 45 biological tissues, in particular, ligaments sectioned by attachment of fibroblasts which may -coloniser said surface. Preferably, the roughness of the adhesion surface is defined by a roughness R1 of at least 50 microns, preferably at least 100 microns. The roughness R1 corresponds to the maximum total distance between the top of the bumps and the bottom of the hollows of the texture of the surface.

  By "sliding surface" is meant a smooth surface, in particular without roughness or hump, with a low coefficient of friction, so as not to prevent the movement of the nerve and tendons with respect to the plate 10. Preferably, the roughness Ra of the sliding surface is less than 4 microns, especially 0.5 to 4 microns, preferably less than 3.2 microns, more preferably less than 0.8 microns. Ra roughness is known to those skilled in the art: it corresponds to an average arithmetic deviation of the hollows and bumps of the surface relative to a mean line.

  The plate 10 is made of non-resorbable materials, such as biocompatible polymers in the form of fibrillar structure, such as polyethylene terephthalate fibers for the first convex face 10e forming the adhesion surface and silicone for the second concave face 10f forming the sliding surface.

  The plate 10 may comprise a first convex face 10e forming the adhesion surface which is advantageously made of a biocompatible polymer material having a microporous structure, in particular with a fibrillar structure, such as a polyester fiber material. Said microporous structure comprises pores whose average size is preferably 50 to 600 microns.

  The plate 10 may comprise a second concave face 10f forming the sliding surface which is made of a biocompatible elastomer material, in particular polyurethane or silicone.

  According to one embodiment, the plate 10 may consist of elastomer, in particular silicone or polyurethane coated on one of its faces and more particularly the first convex face 10e forming the adhesion surface of a wire mesh 3 fibers of a biocompatible polymer, especially polyester, anchored on said face. The term "lattice" refers to a fabric made of multifilament of synthetic fibers with openwork mesh.

  The plate 10 may be covered on at least one of its faces 10e and 10f respectively forming the adhesion surface and the sliding surface of at least one drug layer Cm consisting of a medicinal active principle.

  Also, the plate 10 may be covered on the first two parallel sides 10a, 10b of rectilinear profiles and / or on the second two parallel sides 10c, 10d of curvilinear profiles of at least one medicinal layer Cm consisting of a medicinal active principle to completely cover said plate.

  The plate 10 may be covered with several drug layers Cm each consisting of a different drug active ingredient. It goes without saying that the plate 10 may comprise n drug layers, the number of which varies according to the treatments that it is desired to deliver during the ligament healing time 2 which has been opened during the surgical procedure for the placement of the device. protection of nerves and / or tendons 1.

  The plate 10 may be covered with at least one medicinal layer Cm whose active ingredients may consist of components that make it possible to act, for example, as an anti-fibrous agent, an analgesic, an anti-mitotic, an anti-inflammatory, an anti-adherence, a local anesthetic.

  When the plate 10 is covered with different drug layers Cm, the latter can act separately from each other as a function of the resorption time of each drug layer.

  The resorption time of the drug layer Cm induced directly on the treatment time. Note that the resorption time depends on the thickness of the drug layer Cm knowing that the thickness can vary between said layers.

  When the plate 10 is covered with different drug layers 20 Cm, the latter may be arranged one above the other so as to completely or partially cover the previous layer.

  For this purpose, the medicinal layer Cm totally or partially covering the plate 10 may consist of an active ingredient derived from the family of anti-fibrous agents and whose components belong, for example, to the family of anticancer agents and / or generics. resulting, such as for example anticancer drugs marketed under the names SIROLIMUS or PACLITAXEL.

  The drug layer Cm may consist of an active ingredient whose components make it possible to act, for example, as an anti-pain belonging to the family of analgesics and / or generics derived therefrom.

  The medicamentous layer Cm may consist of an active ingredient whose components make it possible to act, for example, as an anesthetic belonging to the family of local anesthetics and / or generics derived therefrom.

  The medicamentous layer Cm may consist of an active ingredient whose components make it possible to act, for example, as a local anti-pain and / or anti-inflammatory agent. Also, when the drug layer Cm comes to cover the face 10f forming the sliding surface of the plate 10, the latter may consist of an active ingredient belonging to the family of anti-adhesions and / or generics derived therefrom. In a particular embodiment, the drug layer Cm may consist of at least two partial drug layers Cma, Cmb arranged next to each other, of identical or different surface and of similar or different thickness. 40

  The partial drug layers Cma, Cmb may consist of different active ingredients belonging or not to the same family, such as, for example, an analgesic for the medicinal layer Cma and local anti-inflammatory for the drug layer Cmb.

  This provision of partial drug layers Cma, Cmb can be applied to each drug layer Cm covering the plate 10 of the protective device of the nerves and / or tendons 1.

  Finally, the plate 10 may comprise a last layer called inert layer Ci from totally or partially covering the last drug layer Cm for protecting and shifting in time the resorption of said last drug layer Cm. An inert layer Ci may be provided between each medicinal layer Cm coming to cover the plate 10.

  Thus, by way of example, the device for protecting the nerves and / or tendons 1 according to the present invention can deliver, after the disappearance of the inert layer C 1 • in the first place, a drug layer Cm belonging to the family of local anesthetics, • second, a second drug layer Cm belonging to the family of analgesics, and lastly a third drug layer Cm belonging to the anti-fibrous family.

  It goes without saying that all the combinations of one or more drug layer (s) Cm associating one or more drugs are possible without thereby changing the subject of the present invention. The plate 10 comprises, as described in the European patent N 1229866 belonging to the applicant means of attachment to the cut edges 21 of the ligament 2 which consist either of hooks adapted to anchor directly in said edges 21, or of holes formed in the thickness of said plate 35 for the passage of suture elements.

  The plate 10 according to the invention is made with biomaterials, that is to say, implantable materials in the human body without risk of rejection. Biomaterials are well known to those skilled in the art of surgery.

  It must also be understood that the foregoing description has been given only by way of example and that it does not limit the scope of the invention which can not be overcome by replacing the details of execution described. by any other equivalent. 45

Claims (15)

  1. Device for protecting the nerves and / or tendons located in a ductal zone of the human body, normally closed by a ligament (2) and which has been opened during a surgical procedure, characterized in that it comprises at least one plate (10) comprising firstly a first face (10e) said adhesion surface and a second face (10f) said sliding surface and secondly at least one drug layer (Cm) covering completely or partially the at least one of said first and second faces (10e, 10f).   2. Protection device for the nerves and / or tendons according to claim 1, characterized in that the plate (10) has a curved or curved profile delimiting a first convex face (10e) said adhesion surface and a second concave face ( 10f) said sliding surface of which at least one is totally or partially covered with at least one drug layer (Cm).   3. Protection device for nerves and / or tendons according to claim 1, characterized in that the plate (10) is covered on the first two parallel sides (10a, 10b) of rectilinear profiles and / or on the two second sides parallel (10p, 10d) curvilinear profiles, at least one drug layer (Cm).   4. Protection device for nerves and / or tendons according to claim 1, characterized in that the plate (10) is covered with drug layers (Cm) each consisting of a different drug active ingredient.   5. Device for protecting the nerves and / or tendons according to claim 1, characterized in that the plate (10) is covered with drug layers (Cm) having a different thickness in order to determine the resorption time.   6. Protection device for nerves and / or tendons according to claim 1, characterized in that the last drug layer (Cm) of the plate (10) is completely or partially covered with an inert layer (Ci) for protecting and staggering the resorption of said drug layer over time.   7. Protection device of nerves and / or tendons according to claim 6, characterized in that the plate (10) comprises an inert layer (Ci) between each drug layer (Cm).   8. Protection device for nerves and / or tendons according to claim 1, characterized in that the drug layer (Cm) consists of at least two partial drug layers (Cma, Cmb) arranged next to the other.   9. Protection device of the nerves and / or tendons according to claim 8, characterized in that the partial drug layers (Cma, Cmb) may consist of different active ingredients. 10   10.Dispositif protective nerves and / or tendons according to claim 1, characterized in that the drug layer (Cm) consists of an active ingredient whose components belong to the family of anti-fibrous.   11. Protection device for nerves and / or tendons according to claim 1, characterized in that the components constituting the drug layer (Cm) belong to the family of anti-cancer especially antimitotic.   12.Dispositif protective nerves and / or tendons according to claim 1, characterized in that the drug layer (Cm) consists of an active ingredient whose components belong to the family of analgesics.   13. Device for protecting the nerves and / or tendons according to claim 1, characterized in that the drug layer (Cm) consists of an active ingredient whose components belong to the family of local anesthetics.   14.Nerve protection device and / or tendon according to claim 1, characterized in that the drug layer (Cm) consists of an active ingredient whose components belong to the family of anti-inflammatories.   15.Nerve and / or tendon protection device according to claim 1, characterized in that the drug layer (Cm) covering the face (10f) forming the sliding surface of the plate (10) consists of a active ingredient belonging to the family of drugs or anti-adhesion components. 40