FR2705225A1 - Assembly for fitting a flexible fabric prosthesis by endoscopy - Google Patents

Abstract

The present invention relates to an assembly for fitting a prosthesis formed by a flexible fabric (50), characterised in that it comprises: a tubular sheath (100) provided with two longitudinal slots (110, 112) designed to receive the said prosthesis (50), and a winding fork (200) designed to be engaged in the sheath (100), respectively on either side of the prosthesis (50), and to allow the latter to be wound up on the sheath (100) by rotation. The invention also relates to a fitting fork and a kit for sterile packaging of the prosthesis (50), the tubular sheath (100) and the winding fork (200).

Description

 The present invention relates to the field of instruments for endoscopic surgery.

 The present invention relates more specifically to instruments for endoscopic surgery suitable for the placement of prostheses formed from flexible tissue.

 Endoscopic surgery encompasses all the operations which are carried out by introducing the instruments into the body by natural means or by tiny incisions and with examination of the interior of the body using an optical device introduced into the body. by the same means.

 It is known that endoscopic surgery offers many advantages over conventional surgical techniques in which the surgeon operates with an open body.

 The following advantages can be mentioned in particular - endoscopic surgery removes scars, - it is more comfortable for the patient and causes less pain, - it leads to a lower consumption of adjunctive drugs, in particular pain-relieving painkillers , - it allows faster healing, - it allows faster recovery and therefore shorter hospital stays, especially since the operative and postoperative complications related to the opening of the body in conventional techniques, disappear.

 Under these conditions, it is now estimated that over the next ten years, 3/4 of gynecological or digestive system interventions will be performed by endoscopic surgery.

 Many miniaturized instruments have been proposed for this purpose, and in particular pliers, scissors, feelers, electrosurgical units ... All these miniaturized instruments are designed to be introduced into the body, by means of small section trocars.

 In the particular field of fitting prostheses formed from flexible tissue, the devices hitherto proposed are not entirely satisfactory.

 For example, in document EP-A-0 535 506, a system has been described for the application of nonadhesive tissue endoscopically. This system comprises a tissue support comprising a tissue gripping zone, for example in the form of a longitudinal slot or clamp, and a cylindrical applicator tube adapted to receive a tissue wound on the support and to be engaged in a trocar. Before application, the fabric must be wound on the support by rotation of the latter around its axis, then the assembly thus formed must be engaged in the applicator tube. This operation is quite delicate and difficult to carry out under satisfactory aseptic conditions. The tissue is then released and put in place using forceps engaged by other access routes.

 The object of the present invention is to improve the known devices.

 This object is achieved in the context of the present invention thanks to an assembly for fitting a prosthesis formed from a flexible fabric, characterized in that it comprises - a tubular sheath provided with two longitudinal slots adapted to receive said prosthesis, and - a winding fork designed to be engaged in the sheath, respectively on either side of the prosthesis and allow the winding thereof in the sheath, by rotation.

 As will be clarified below, the assembly according to the present invention offers numerous advantages compared with known prior devices.

 First of all the assembly according to the present invention allows rapid winding and positioning of the prosthesis, while the prior devices required a long and delicate implementation.

 Then, the assembly according to the present invention allows a perfectly aseptic implementation, while the prior devices left something to be desired on this point and sometimes generated foci of infection.

 Finally, the assembly according to the present invention allows the prosthesis to be wound up at the very last moment, before its engagement in a trocar for implantation, which avoids any memorization of this wound shape, as it is encountered for prostheses stored for a long time in the rolled up state before use.

 According to another advantageous characteristic of the present invention, the assembly also comprises a positioning fork comprising two branches resiliently biased away.

 The present invention also relates to the aforementioned positioning fork as such and a kit grouping, in sterile packaging, a tubular slot sheath, a prosthesis and a winding fork.

 Other characteristics, objects and advantages of the present invention will appear on reading the detailed description which follows, and with reference to the appended drawings given by way of nonlimiting example and in which - FIG. 1 represents a schematic view in perspective of a slotted tubular sheath associated with a prosthesis, - Figure 2 shows a corresponding winding fork according to a first embodiment of the present invention, - Figures 3 and 4 schematically illustrate the winding phase of the prosthesis, using the fork, in the tubular sheath, - Figure 5 schematically illustrates the kit grouping, in sterile packaging, a slotted tubular sheath, a prosthesis and a winding fork, - Figure 6 shows a positioning fork according to the present invention, - Figure 7 shows the associated tubular sheath, - Figure 8 shows the positioning fork e introduced into the tubular sheath, and - Figure 9 schematically illustrates the phase of placing the prosthesis using the aforementioned fork.

 We will first describe the basic assembly of the present invention comprising a tubular sheath 100 and a winding fork 200 as shown in FIGS. 1 to 5.

 The tubular sheath 100 is made of any suitable sterilizable material, in particular plastic or metal.

 The tubular sheath 100, centered on an axis 102, comprises two longitudinal slots 110, 112. Said slots 110, 112 are preferably diametrically opposite. They are advantageously rectilinear and parallel to the axis 102.

 Said longitudinal slots 110, 112 are adapted to receive the prosthesis 50 formed of a flexible tissue. The prosthesis 50 can be formed from any suitable material known to those skilled in the art. These are, for example, but not limited to, prostheses 50 intended for the treatment of hernias.

 The geometry of the prosthesis 50 can also be the subject of numerous variant embodiments.

According to the nonlimiting embodiment shown in the figures, the prosthesis 50 has a rectangular outline. The invention is however not limited to this particular geometry. It also applies for example to the installation of prosthesis 50 of circular outline.

 It is important that the length of the slots 110, 112 is at least slightly greater than one of the dimensions of the prosthesis 50. The prosthesis 50 of rectangular outline can typically have dimensions of 10 × 12 cm.

 As can be seen in FIG. 1, when the tubular sheath 100 is positioned on the prosthesis 50, the latter is engaged in the slots 110, 112 and consequently crosses the internal volume 104 of the sheath 100, emerging on the outside of the sleeve 100 respectively by each of the slots 110, 112.

 The winding fork 200 is designed to be engaged in the sheath 100 respectively on either side of the prosthesis 50 and allow the winding of the latter in the sheath 100, by rotation about the axis 102, as shown in particular in Figures 3 and 4.

 The winding fork 200 can be the subject of numerous variant embodiments. It is also made of any suitable sterilizable material, such as in particular plastic or metal.

 According to the particular embodiment shown in FIG. 2, the winding fork 200 comprises a base 210 provided with two rectilinear branches parallel to each other 220, 222. It will be noted that preferably, the free ends 221, 223 of the branches 220, 222 are tapered to facilitate the insertion of the winding fork 200 into the sheath 100.

 Is illustrated in Figure 3, the engagement phase of the fork 200 in the sleeve 100 respectively on either side of the prosthesis 50. In other words, during this engagement phase the two branches 220 , 222 are placed on opposite sides of the prosthesis 50, in the internal volume 104 of the sleeve 100.

 I1 then suffices to drive the fork 200 in rotation, in one direction or the other, around the axis 102, to wind the prosthesis 50 inside the sheath 100, around said branches 220, 222 of the fork 200.

 It will be noted that during this winding phase, two windings of the prosthesis 50 are made more precisely on itself using respectively the two branches 220, 222.

 Illustrated in Figure 5, a sterile packaging kit 300 receiving a tubular sheath 100, a prosthesis 50 and a winding fork 200 as described above.

 Those skilled in the art will readily understand that after opening the packaging 300 as illustrated in FIG. 5, an operator can aseptically wind the flexible fabric 50 by rotating the winding fork 200 under cover of the peelable bag 300.

 Once wound inside the sheath 100, as described above, the prosthesis 50 can be put into place in the body by any suitable means taking the place of a push rod capable of ejecting said prosthesis outside the sheath 100. Where appropriate , the prosthesis 50 can be put in place using the winding fork 200 itself, provided that the latter is adapted, in particular as regards its base 210, to pass through the sheath 100 on the one hand, and preferably to be attached to the end of an applicator rod on the other hand.

 However, preferably, the above-mentioned winding fork 200 is for single use and discarded after the above-mentioned winding phase in order to be replaced, during installation, by a positioning fork 400 of the type shown on Figures 6 and following.

 This positioning fork 400 has a base 410 provided with two branches 420, 430 which are resiliently biased away.

 In a manner comparable to the winding fork 200, preferably the free ends 422, 432 of the branches 420, 430 of the positioning fork 400 are tapered to facilitate the engagement of the positioning fork 400 in the sheath 100.

 Preferably, the two branches 420, 430 are rectilinear. The positioning fork 400 may comprise a rigid fork 430 and an elastic fork 420 urged away from the latter, or two branches 420, 430 urged away from one another symmetrically with respect to the base axis 410.

 Here again, the positioning fork 400 is made of any suitable sterilizable material, such as in particular plastic or metal.

 The positioning fork 400, including its base 410 is adapted to pass through the tubular sheath 100 as seen in particular in FIGS. 8 and 9.

 Thus, when the positioning fork 400 is engaged on the prosthesis 50 wound in the sheath 100 and translated relative to the sheath 100 to pass through the latter, as shown in FIG. 9, the prosthesis 50 is released automatically as soon as the positioning fork 400 almost completely emerges from the sheath 100. It should be noted that the double winding of the prosthesis 50 inside the sheath 100 facilitates its subsequent deployment.

 In addition, once deployed, the positioning fork 400 can be used as an applicator to facilitate the handling and positioning of said prosthesis 50, or even as a retractor to move, if necessary, the surrounding tissues of the body receiving the prosthesis.

 To allow relative translation of the tubular sheath 100 and the positioning fork 400 under endoscopy, inside the body, the base 410 of the positioning fork and the tubular sheath 100 are preferably adapted to be fixed on a respective end of two applicator rods designed to be engaged in a common trocar. In FIG. 9, only the applicator rod 440 associated with the positioning fork 400 has been illustrated. The applicator rod associated with the tubular sheath 100 is not shown to simplify the illustration. In practice, the two applicator rods can be parallel to each other in the access trocar, or even concentric with one another.

 Furthermore, it has been indicated above that preferably the winding of the prosthesis 50 inside the sheath 100 was carried out using a specific single-use fork 200 stored sterile in the package 300 with the sheath 100 and the prosthesis 50, which winding fork 200 was discarded after winding and replaced by the positioning fork 400.

 As a variant, however, provision may be made to use the fork 400 with elastic branches during the winding phase of the prosthesis 50. In this case, the winding fork 200 and the positioning fork 400, are merged.

 Of course the present invention is not limited to the particular embodiments which have just been described but extends to any variant in accordance with its spirit.

 Thus, for example, the aforementioned applicator rods used to manipulate the sheath 100 and the positioning fork 400 may be permanently integral with the latter, or adapted to be fixed removably thereon, by any suitable means, such as by cooperation by threading, bayonet mounting or snap-fastening.

 It will be readily understood that the assembly according to the present invention offers decisive advantages over the system described in document EP-A-0 535 506.

In particular, the slotted sheath according to the present invention makes it possible to wind the tissue in sterile packaging, without having to intervene manually to engage a preformed roller in an applicator tube as is required with the means of document EP-A-0 535 506.

Then the positioning fork with elastic branches in accordance with the present invention makes it possible to facilitate the release and the positioning of the fabric without requiring the use of clamps engaged by additional access paths as is required with the means of document EP-A-0 535 506.

Claims (14)

 1. Assembly for fitting a prosthesis formed from a flexible fabric (50), characterized in that it comprises - a tubular sheath (100) provided with two longitudinal slots (110, 112) adapted to receive said prosthesis (50), and - a winding fork (200) designed to be engaged in the sheath (100) respectively on either side of the prosthesis (50) and allow the winding of the latter in the sheath (100) by rotation.  2. Assembly according to claim 1, characterized in that it further comprises a positioning fork (400) comprising two branches (420, 430) resiliently biased away.  3. Assembly according to one of claims 1 or 2, characterized in that the two longitudinal slots (110, 112) of the sleeve (100) are substantially rectilinear and diametrically opposite.  4. Assembly according to one of claims 1 to 3, characterized in that the longitudinal slots (110, 112) of the tubular sheath (100) have a length greater than one of the dimensions of the prosthesis (50).  5. Assembly according to one of claims 1 to 4, characterized in that the winding fork (200) has two straight branches (220, 222) with tapered ends to facilitate the insertion of said fork (200) in the tubular sheath (100).  6. Assembly according to one of claims 1 to 5 taken in combination with claim 2, characterized in that the positioning fork comprises two branches (420, 430) resiliently biased away symmetrically relative to a base (410).  7. Assembly according to one of claims 1 to 5 taken in combination with claim 2, characterized in that the positioning fork (400) comprises a rigid branch (430) and an elastic branch (420).  8. Assembly according to one of claims 1 to 7, characterized in that it is made of a plastic or a sterilizable metal.  9. Assembly according to one of claims 1 to 8, characterized in that the tubular sheath (100) is adapted to be removably fixed on the end of an applicator rod designed to be engaged in a trocar of access.  10. Assembly according to one of claims 1 to 8, characterized in that the tubular sheath (100) is integral with the end of an applicator rod adapted to be engaged in an access trocar.  11. Assembly according to one of claims 1 to 10 taken in combination with claim 2, characterized in that the positioning fork (400) is adapted to be fixed on the end of an applicator rod designed for be engaged in an access trocar.  12. Assembly according to one of claims 1 to 10 taken in combination with claim 2, characterized in that the positioning fork (400) is integral with the end of an applicator rod adapted to be engaged in an access trocar.  13. Implementation fork comprising two branches resiliently biased in distance according to one of claims 2 to 12.  14. Kit comprising a sterile packaging (300) housing a tubular sheath (100), a flexible fabric prosthesis (50) and a winding fork (200) according to one of claims 1 to 13.