TEXTILE-BASED PROTHESIS FOR LAPAROSCOPIC SURGERY

Abstract

The invention relates to a prosthesis (1) comprising a textile (2) of elongate shape defining a longitudinal axis A, and a reinforcing element comprising at least one semi-rigid elongate structure (8) connected to said textile, said structure being substantially parallel to said longitudinal axis A and having a distal end provided with at least one fastening element (4) distinct from said textile and capable of cooperating with a part of a tool (10) that is able to pass through said trocar, in order to temporarily couple said prosthesis to said tool.

Claims

1. (canceled)

2. A method of conveying a prosthesis to an implantation site comprising: providing a prosthesis including at least one flexible biocompatible textile having a first face and second face opposite the first face, a shape defining a longitudinal axis, and at least one reinforcing element for said textile, wherein the at least one reinforcing element includes a semi-rigid elongate structure fixed to the first face of the textile, the semi-rigid elongate structure being substantially parallel to the longitudinal axis and having a distal end provided with at least one fastening element having a shape of a ring distinct from the textile, engaging the at least one fastening element with a part to a tool configured to pass through a trocar, thereby coupling the prosthesis to the tool via the at least one fastening element, introducing the part of the tool coupled to the prosthesis into a proximal orifice of a trocar causing the prosthesis to automatically fold into a compact configuration as the tool and the prosthesis is moved distally to penetrate into the proximal orifice of the trocar, and passing the prosthesis through a distal orifice of the trocar to the site of implantation wherein the prosthesis unfolds from the compact configuration to a spread-out configuration.

3. The method of claim 2, wherein the part of the tool is a jaw member of a laparoscopic surgical tool.

4. The method of claim 3, wherein the laparoscopic surgical tool is a surgical forceps.

5. The method of claim 2, wherein passing the prosthesis through the distal orifice of the trocar is continued until the whole prosthesis emerges completely from the trocar.

6. The method of claim 2, further comprising uncoupling the prosthesis from the tool.

7. The method of claim 2, further comprising positioning the prosthesis opposite a hernia defect at the site of implantation.

8. The method of claim 7, further comprising fixing the prosthesis at the site of implantation.

9. The method of claim 2, wherein the prosthesis automatically folds along one or more longitudinal folds.

10. The method of claim 2, wherein the textile alone does not have an inherent elasticity allowing the prosthesis to spontaneously recover a spread-out configuration after folding.

11. The method of claim 2, wherein the ring is an open ring.

12. The method of 11, wherein an opening in the open ring is situated substantially in a proximal region of the open ring.

13. The method of claim 2, wherein the ring is a closed ring.

14. The method of claim 2, wherein the at least one reinforcing element is located on a central longitudinal axis of the first face of the textile distal a semi-rigid frame located on a center of the first face of the textile.

15. The method of claim 2, wherein the at least one reinforcing element includes a first reinforcing element separate from a second reinforcing element, the first reinforcing element including a first fastening element having a shape of a first ring on a distal end thereof and the second reinforcing element including a second fastening element having a shape of a second ring on a distal end thereof, wherein the first and second reinforcing elements extend parallel to each other and the longitudinal axis.

16. The method of claim 15, wherein engaging the at least one fastening element comprises engaging successively the first and second rings creating two or more longitudinal folds in the textile.

17. A method of conveying a prosthesis to an implantation site comprising: engaging at least one fastening element having a shape of a ring with a part of a tool configured to pass through a trocar, the fastening element located on a distal end of a semi-rigid reinforcing element secured to a first face of a textile, the semi-rigid reinforcing element being substantially parallel to a longitudinal axis of the textile, and the ring being distinct from the textile, introducing the part of the tool coupled to the prosthesis into a proximal orifice of a trocar causing the prosthesis to automatically fold into a compact configuration as the tool and the prosthesis is moved distally to penetrate into the proximal orifice of the trocar, and passing the prosthesis through a distal orifice of the trocar to the site of implantation wherein the prosthesis unfolds from the compact configuration to a spread-out configuration.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0065] The advantages of the present invention will become clearer from the following detailed description and from the attached drawings in which:

[0066] FIG. 1 shows a plan view of a first embodiment of a prosthesis according to the invention,

[0067] FIG. 2 shows a view of a step during which a jaw of a pair of forceps able to pass through a trocar is engaged in the fastening elements of the prosthesis of FIG. 1,

[0068] FIG. 3 is a view, on an enlarged scale, of a jaw of a pair of forceps being engaged in the fastening elements of the prosthesis of FIG. 1,

[0069] FIG. 4 is a view of the forceps of FIG. 2 engaged in the fastening elements of the prosthesis of FIG. 1 on emergence from the trocar,

[0070] FIG. 5 is a plan view of a second embodiment of the prosthesis according to the invention,

[0071] FIG. 6 is a plan view showing a step during which a jaw of a pair of forceps able to pass through a trocar is engaged in the fastening element of the prosthesis of FIG. 5.

DETAILED DESCRIPTION OF EMBODIMENTS

[0072] FIG. 1 shows an embodiment of a prosthesis 1 according to the invention. The prosthesis 1 comprises a biocompatible textile 2 and a reinforcing element in the form of two semi-rigid elongate structures 8. Each elongate structure 8 comprises a rod segment 3 provided with a fastening element, in the form of a closed ring 4, at the distal end 3a thereof.

[0073] As will be seen from FIG. 1, the textile 2 has a generally elongate shape defining a longitudinal axis A. In another embodiment, the textile could have the shape of a disc, in which case one of the diameters of the disc would define the longitudinal axis of the textile.

[0074] Referring to FIG. 1, the textile 2 is thus delimited by a peripheral outer edge 2a forming substantially two opposite long sides 2b, which are substantially parallel to the longitudinal axis A, and two opposite short sides 2c, which are substantially perpendicular to the longitudinal axis A. In the example shown, the textile 2 has the general shape of a rectangle. Such an embodiment is suitable for the repair of a hernia of the abdominal wall, for example.

[0075] In other embodiments, the textile 2 could have an oval shape, or an elliptic shape, or be protean.

[0076] The textile 2 is made up of an arrangement of biocompatible filaments, such as a knit, a woven or a nonwoven. Preferably, as is shown in FIG. 1, the textile 2 is in the form of a mesh, that is to say it has openings for better tissue integration. For example, the textile 2 can be a two-dimensional or three-dimensional knit. Such textiles in the form of meshes or knits are well known to a person skilled in the art and are not described in any greater detail here.

[0077] The textile 2 can be bioresorbable, permanent or partially bioresorbable. As will become clear from the description below, the textile 2 is sufficiently flexible to be folded up, in particular at the time of introduction of the prosthesis into a trocar, along one or more longitudinal folds. In general, however, the textile 2 does not have an inherent elasticity allowing it to spontaneously recover a spread-out configuration once it has been folded up. The textile 2 can be supplied in the form of a band, which one cuts to the dimensions of the defect to be treated.

[0078] Referring again to FIG. 1, and as will become clear on reading the description below, the elongate structures 8 are parallel to each other and parallel to the longitudinal axis A. The rod segments 3 serve as an element for reinforcing the textile 2, in order to stiffen the latter and keep it in a substantially spread-out state in the absence of any external stress, as shown in FIG. 1, and also as a tool permitting both the manipulation of the textile 2 and the guiding of the prosthesis 1 upon introduction of the latter into a trocar, and also as a tool for assisting in the deployment of the prosthesis 1 when the latter emerges from the trocar at the implantation site. For this purpose, the elongate structures, in particular the rod segments 3, are connected to the textile 2 and have a rigidity allowing them to keep the textile 2 in its substantially spread-out state in the absence of any external stress, and allowing them to be gripped by a tool conventionally used in laparoscopic surgery, such as forceps intended to pass through a trocar.

[0079] The elongate structures 8, in particular the rod segments 3, are connected to the textile 2. They can be attached to the textile 2 by means of a seam, or else by means of an ultrasonic weld, by adhesive bonding, or by injection moulding.

[0080] In one embodiment, the rod segments 3 are joined to the textile by means of injection moulding. Such an embodiment makes it possible to secure the fixing of the rod segments 3 to the textile 2 in a particularly effective manner and to produce the prostheses according to the invention at an industrial scale.

[0081] In the technique of injection moulding, a mould is formed in which, for example with reference to the example shown in FIG. 1, a cavity is provided that is formed by two channels corresponding to the two rod segments 3 that are to be obtained, these two channels being parallel to each other. The textile is held in an insert gate of the mould, the long sides 2b of its peripheral outer edge 2a being parallel to the two channels. The thermoplastic material used to produce the rod segments, for example a copolymer of polylactic acid and of polyglycolic acid, is heated and injected into these channels using an injection moulding machine.

[0082] After the injection step, the mould is opened and the prosthesis 1 is withdrawn from the mould. Such a method allows the textile to be “embedded” in the part moulded over it. Thus, the rod segments 3, which are the overmoulded parts, are connected to the textile 2, without any risk of their coming loose or fragmenting.

[0083] On account of the nature and the structure of the rod segments 3, the latter act as guides for introducing the prosthesis 1 into a small orifice, such as an admission orifice of a trocar, as will become clear from the description below.

[0084] Thus, in order to easily introduce the prosthesis 1 of FIG. 1 into a trocar, the user makes use of a tool that is able to pass through a trocar, for example forceps 10 as shown in FIGS. 2 and 3. Referring to these figures, the forceps 10 are provided, at the distal end 10a thereof, with two jaws 11 that are capable of opening and closing in order to release or, by contrast, imprison a component. The user holds the forceps 10 with the two jaws open and engages one 11 of these two jaws successively into each of the two rings 4 present at the respective distal ends 3a of the rod segments 3 (see FIG. 3). On doing this, as shown in FIG. 2, one or more longitudinal folds 5 are created in the textile 2. Depending on the number of rod segments 3 present, the textile 2 can form one or more longitudinal folds 5, like an accordion.

[0085] In the example shown, the fastening element is a closed ring 4. It is clear from FIG. 3 that such a closed ring 4 could be replaced by an open ring (not shown), of which the opening would be situated in the proximal region of the ring. Indeed, since the forceps 10 are intended to be moved in the distal direction once coupled to the prosthesis 1, the absence of material in the proximal region of the ring does not prevent the effective coupling of the prosthesis to the forceps and the transport of the prosthesis in the distal direction by the tool, once the latter has been coupled to the prosthesis.

[0086] The ring 4 is dimensioned so as to be able to receive a jaw of a pair of forceps, that can pass through a trocar of small diameter, for example a diameter of 5-15 mm, and also so as to be able itself to pass easily through the trocar. Thus, for example, for using the prosthesis according to the invention with a trocar having an internal diameter of 5-15 mm, the ring 4 has an external diameter of less than 10 mm, for example of approximately 5 mm.

[0087] The fastening element, i.e. the closed ring 4 in the example shown, is distinct from the textile 2. The ring 4 is not moulded on the textile 2. This is because the ring 4 has to be able to receive a projecting element of a tool for laparoscopic surgery, in order to be able to couple the prosthesis to said tool, but said projecting element must not engage the textile 2 itself. Thus, when the tool is engaged in the ring 4, said tool is not in contact with the textile 2, and the risks of the textile 2 being damaged, for example by being caught by a projecting part of the tool, are avoided. Therefore, the integrity of the structure of the textile, in particular its openworked structure when the textile is a mesh for example, is not affected when the tool is coupled to the prosthesis.

[0088] Referring to FIGS. 2 and 3, it is clear that the jaw 11 engaged in the two rings 4 is not in contact with the textile 2 and, therefore, does not risk damaging the latter. As is shown in FIG. 3, the forceps 10 can be arranged in a position in which they are substantially aligned on the rod segments 3.

[0089] Thus, when a user moves the forceps 10 in the distal direction symbolized by the arrow F in FIG. 3, the prosthesis 1 is transported along with the forceps 10 in this same direction. The user then introduces the distal end 10a of the forceps 10 into the proximal entrance (not shown) of the trocar 12 shown in FIG. 4. As the user gradually pushes the distal end 10a of the forceps 10 inside the trocar 12 in the distal direction, the textile 2 is guided by the rod segments 3, which are semi-rigid, and it folds up along one or more longitudinal folds similar to the longitudinal folds 5 of FIG. 2 and aligned on the rod segments 3. Thus, the prosthesis 1 adopts a compact configuration that allows it to easily pass through the trocar 12. The rod segments 3 serve as guide elements for the folding of the prosthesis 1 along longitudinal folds.

[0090] FIG. 4 shows the distal end 10a of the forceps 10 after passage through the trocar 12, at the moment when the forceps emerge from the trocar 12 via the distal end 12a thereof. The textile 2 is coupled to a jaw 11 of the forceps 10 by engagement of the rings 4 in this jaw 11. The user continues to push the forceps 10 in the distal direction until the whole prosthesis 1 has emerged completely from the trocar 12. The user then uncouples the prosthesis 1 from the jaw 11 of the forceps 10, and he is then able to deploy the prosthesis 1 with the aid of the rod segments 3 in order to keep the textile 2, and therefore the prosthesis 1, in a spread-out state.

[0091] The prosthesis 1 is then ready to be positioned opposite a hernia defect that is to be treated. During the positioning of the prosthesis 1, the latter can be easily manipulated by means of tools conventionally used in laparoscopic surgery, these tools being able, among other things, to take hold of all or some of the elongate structures 8.

[0092] FIGS. 5 and 6 show another embodiment of the prosthesis 1 according to the invention, in which the textile 2 has generally the shape of an ellipse defining a longitudinal axis A. As in the preceding embodiment, the textile 2 is delimited by a peripheral outer edge 2a forming substantially two opposite long sides 2b, which are substantially parallel to the longitudinal axis A, and two opposite short sides 2c, which are substantially perpendicular to the longitudinal axis A. An ellipse shape of this kind is suitable for the repair or a hernia of the abdominal wall, for example.

[0093] In this embodiment, the reinforcing element comprises a semi-rigid elongate structure 8 comprising a rod segment 3, which is generally aligned on the longitudinal axis A and which is provided with a fastening element in the form of a closed ring 4 at the distal end 3a thereof. The rod segment 3 is situated in the distal region of the textile 2 and, therefore, of the prosthesis 1. The structure 8 additionally comprises two oblique rod segments 6, which each form an angle .alpha. with the longitudinal axis A and are generally situated proximally with respect to the proximal end of the rod segment 3. Finally, the elongate structure 8 also comprises a triangular frame 7 extending in the longitudinal direction and arranged between the rod segment 3 and the oblique rod segments 6. Such a shape of the structure 8 facilitates the automatic folding of the textile 2 along longitudinal folds at the moment when the textile 2, coupled to trocar forceps, is introduced into a trocar.

[0094] Furthermore, the triangular frame 7 forms an indicator of the centre of the textile 2 and also a means of information concerning the orientation of the prosthesis 1. This is because the triangular frame 7 itself is of elongate shape and indicates to the surgeon the longitudinal direction of the prosthesis 1. Finally, the short side of the triangular frame 7 indicates the proximal direction, while the angle opposite this short side indicates to the surgeon the distal direction. Such an indicator of a defined location of the textile and a such means of information concerning the prosthesis are particularly useful to the surgeon when the prosthesis 1 has reached the implantation site, where the field of view is reduced and/or obstructed by the presence of the surrounding organs.

[0095] FIG. 6 shows the step in which a jaw 11 of a pair of forceps 10 is coupled to the textile 2, and therefore to the prosthesis 1, with a view to introducing the prosthesis 1 into a trocar (not shown).

[0096] The prosthesis according to the invention can thus be easily introduced into a trocar, without any risk of forming a plug inside the trocar. By virtue of its nature and its structure, the reinforcing element of the prosthesis according to the invention stiffens the prosthesis and serves as an element for guiding and transporting the prosthesis inside a trocar conduit of particularly small diameter, such as a diameter of 5-15 mm. The reinforcing element, by stiffening the textile of the prosthesis, also serves to spread the prosthesis out at the moment when the latter emerges from the trocar at the implantation site.