FR2863277A1 - CHAIN KNIT FOR SURGICAL USE - Google Patents

Abstract

According to the invention, the warp knit for surgical use in biocompatible yarns is characterized in that it has a woven chain weave.Application to the production of wall reinforcement prostheses or bands for the treatment of stress incontinence .

Description

The present invention relates to the technical field of fabrics or tablecloths

  textile for surgical use intended to be implanted to reinforce muscle regions, soft tissues or walls of internal organs of the human body.

  In the above field, it is known to use plates of biocompatible materials, nonwoven fibers or cross-threaded fabrics which are cut by the surgeon according to his need.

  If such sheets of textile materials actually make it possible to provide flexible implantable reinforcing means, they nevertheless have certain disadvantages. Firstly, because of their cuts, the reinforcing plates thus obtained have edges that are likely to injure the tissues at which they are placed.

  Moreover, given their structure, such plates are likely to release free particles that may affect the healing of implantation tissue. In addition, in the context of certain uses such as, for example, the production of strips for the treatment of stress urinary incontinence, these strips have the disadvantage of being deformed and wound on themselves when longitudinal force or traction is exerted on them.

  Similarly, such strips cut in cross-threaded fabrics have a certain elasticity that renders them unsuitable for use in the context of implanting without residual tension as is more particularly sought in the context of the new treatment protocols of the invention. urinary stress incontinence.

  In order to overcome this drawback, a patent application WO 02065944 has proposed a warp knit for surgical use made of biocompatible yarns and having, at its longitudinal selvedges, free loops intended to form implantation elements.

  The knit, according to the application WO 02 065 944, then has a single knit type armor with a bar or even an armor of the atlas type presenting too much sensitivity to unraveling so that its characteristics can be affected when the surgeon has been brought to the during the implantation procedure, to damage the test strip.

  US Patent 5,456,711 has also proposed a surgical warp knit made of compatible materials having a two-bar weave more commonly known as queenscord. This knit has the particularity of offering a better resistance to unraveling than the previous knitwear but nevertheless has the drawback of not offering porosity favoring a rapid process of healing.

  It therefore appeared the need to have a new type of knitting that is suitable for implantation in the context of so-called tensionless procedures for the treatment of cystocele or urinary stress incontinence of female effort, which is indémaillable and that is, Moreover, it is particularly favorable for rapid fibroplastic colonization to promote optimal and pain-free healing.

  In order to achieve this objective, the invention relates to a warp knit for surgical use in biocompatible yarns, characterized in that it has a halftone chain weave.

  Indeed, it has been found that such a halftone warp armor provides an opening factor and pores of sufficient size to promote fibroplastic colonization. Furthermore, such a halftone chain weave is particularly favorable for obtaining a blocked knit very little demaillable and therefore resistant to any cuts likely to be performed accidentally or voluntarily by the surgeon during implantation .

  According to one characteristic of the invention, the warp knit is produced so as to have a closed chain type 1-0 or, incidentally, open chain type 1-0 / 0-1 and a binding type of the type 0-0 / 3-3.

  According to another characteristic of the invention, the knit is made in such a way as to have a closed chain-type pattern 1-0 and a type binding pattern 1-0 / 2-3 which reinforces the knitting nature of the knit.

  A warp knit according to the invention can be made on any type of suitable knitting machine such as, for example, knitting looms comprising two bars such as RACHEL looms or CROCHET looms.

  In the context of an implementation in a loom with two guide bars, one of the bars then provides the chain pattern while the other bar provides the binding pattern.

  In order to be particularly favorable to the fibroplastic colonization mechanism, the warp knit according to the invention is designed so as to have pores whose size is in a dimension at least greater than 74 μm and preferably, but not necessarily, in all dimensions between 20 m and 80 m.

  Preferably, the warp knit according to the invention is produced in the form of a ribbon with sharp edges which will preferably but not necessarily have a width of between 8 mm and 55 mm, and more particularly preferably, including between 8 mm and 15 mm. Such an embodiment of the warp knit according to the invention makes it particularly suitable for the production of a reinforcing strip for the treatment of cystocele or urinary stress incontinence, comprising at least one length of knit according to the invention. .

  According to another characteristic of the invention, and always with a view to obtaining optimum healing results, the warp knit according to the invention is produced so as to have a weight per unit area of between 28 g / m 2 and 100 g / m 2 and, more preferably, between 30 g / m2 and 40 g / m2.

  According to the invention, the warp knit for surgical use can be made of son of biocompatible synthetic materials such as, for example, son of polyamide, polyoxymethylene, polyetherketone, polypropylene, polyethylene or polyester. Preferably, but not strictly necessary, the constituent yarns of the warp knit according to the invention will be chosen from polypropylene, polyester and polyamide. It should be noted that in a more particularly preferred embodiment, the warp knit according to the invention would be made of polypropylene yarns.

  Different types of yarn can be used for producing a warp knit according to the invention, such as, for example, multifilament yarns or monofilament yarns. Preferably, the monofilament yarns will be retained because of their low proportion to release particles.

  Thus, in a preferred embodiment, the warp knit according to the invention will be knitted by means of monofilament yarns whose diameter is between 0.017 mm and 0.15 mm and preferably between 0.05 mm and 0.10 mm.

  According to another characteristic of the invention, in order to have a high dimensional stability, the warp knit for surgical use according to the invention will undergo a thermofixation primer at a temperature between 120 C and 140 C and, preferably, between 125 C and 135 C

  Such a heat-setting primer can be achieved either by steaming or by calendering.

  The invention also relates to the use of a knit according to the invention for producing an implantable prosthesis and, preferably, the user of a knit according to the invention in the form of a ribbon with a smooth edge.

  The invention also relates to the use of a knit according to the invention for reinforcing an internal region of the human body, as part of a surgical implantation.

  Various other features of the invention will become apparent from the description below with reference to the accompanying drawings which illustrate preferred embodiments of a surgical warp knit according to the invention.

  Fig. 1 is a photograph illustrating a first embodiment of a warp knit according to the invention.

  Fig. 2 is a detail view illustrating the entanglement of the mesh knit chain according to the invention.

  Fig. 3 is an optical microscope view of the warp knit as shown in FIG. 1.

  Fig. 4 is a simplified representation of the structure of the warp knit, as illustrated in FIGS. 1 and 2.

  Fig. 5 is a simplified representation of an alternative embodiment of a warp knit according to the invention.

  The aim of the invention is to propose a warp knit as illustrated in FIG. 1 and designated in its meaning by the reference 1, particularly suitable for surgical use and, in particular, the treatment protocol of the cystocele by strengthening the muscles in the pelvic area, in order to support the ureter by means of a strip.

  Thus, a warp knit according to the invention will be produced by means of biocompatible yarns, such as, for example, made of synthetic material such as polyamide, polyoximethylene, polyetherketone, polypropylene, polyethylene or polyester.

  According to the invention, the knit 1 can be made of any type of yarn, such as, for example, multi-filament yarns and mono- or multi-materials.

  Preferably, the knit 1 according to the invention will rather be made of monofilament yarns whose diameter will be between 0.017 mm and 0.15 min and, preferably, between 0.05 mm and 0.10 mm.

  In a more particularly preferred form, the knit 1 according to the invention will be made from polypropylene monofilament yarns having a diameter of about 0.08 mm.

  As shown in fig. 1, the knit warp 1 is preferably knitted in the form of a band or ribbon having selvedges 2 and 3 smooth. Preferably and not strictly necessary, the knit 1 will be made in the form of a band having a width 1 of between 8 mm and 55 mm and, more preferably, between 8 mm and 15 mm, in order to achieve support strips for the treatment of the cystocele for example.

  As described above, in accordance with a preferred embodiment of the invention, the selvedges 2 and 3 are made cleanly so as to have no free filaments capable of injuring the tissues when they are put into place. in place of the strip.

  The knit 1 according to the invention is made to have a low elasticity or even, if possible, a lack of elasticity for setting up without tension. In order to achieve this objective, the knitting is carried out on the basis of a chain-link weave, knitted on a RACHEL loom presenting at least two guide bars or, again, a hook loom.

  In the context of an embodiment on a loom with two bars with pucks, the knit 1, as illustrated in FIG. 1, is achieved by adopting the binding scheme, as shown schematically in FIG. 2. Thus, the thread 10 represents the pattern made by the first bar corresponding to a closed chain which has a scale of 1-0 type. Furthermore, the wire 12, shown in phantom, shows the binding made by means of the second guide bar according to a scale of 0-0 / 3-3 type.

  In a manner known per se from those skilled in the art, the scale, as previously expressed, represents the jumps or throws of the guide bars from one rank to another, the coordinate 1 corresponding to an intermediate position between the two first columns of needles on the left.

  The knit obtained then has a structure seen under a microscope as illustrated in FIG. 3.

  The structure has, among other advantageous features, the property of being undemaillable, so that the surgeon can make several partial cuts, without this may cause complete unraveling of all the implanted knit.

  In addition, the structure of the halftone chain armor has the advantage of providing pores that have a size, in at least one of their three dimensions, greater than 74 m. Thus, according to the illustrated example, the main pores 15 have a rectangular shape whose width 115 is greater than 74 m.

  The knit according to the invention will preferably be made so as to have a surface weight of the order of 35 g / m 2, knowing that this weight may be between 28 g / m 2 and 100 g / m 2, such a weight being in favor of a good implementation.

  Fig. 4, in which the same references 10 and 12 have been adopted for the threads corresponding to the two guide bars, illustrates an embodiment variant with an open chain pattern of scale 10 / 0-1 and binding pattern of the type 0-0. / 3-3.

  In another variant embodiment, the knit will be made in such a way as to have a perfectly unmountable structure.

  For this purpose, the second bar, supporting the wire 12, will then be animated with a symmetrical gimbal movement with respect to the chain bar and confer, for example, an armor whose scale will be 1-0 for the chain and 1-0 / 2-3 for the binding yarn 12, as schematically illustrated in FIG. 5.

  Of course, various other modifications can be made to the invention without departing from its scope.

Claims (12)

  1 - Knit chain for surgical use biocompatible son, characterized in that it has a chain of chain armor.   2 - Surgical warp knit according to claim 1, characterized in that it has a closed chain pattern, type 1-0 and a binding pattern type 0-0 / 3-3.   3 - warp chain for surgical use according to claim 1, characterized in that it has a closed chain type 1-0 pattern and a type 1-0 / 2-3 binding pattern.   4 - Surgical chain knit according to one of claims 1 to 3, characterized in that it is obtained on a knitting machine comprising two guide bars, a bar providing the chain pattern and a bar providing the pattern of bonding.   Surgical chain knit according to one of claims 1 to 4, characterized in that it has pores (15) at least the size of which is in a dimension at least greater than 74 m.   6 - warp chain for surgical use according to one of claims 1 to 5, characterized in that it is in the form of a ribbon with clear edges.   7 - A surgical warp knit according to claim 6, characterized in that it has a width (1) of between 8 mm and 55 mm and, preferably, between 8 mm and 15 mm.   8 - Surgical chain knit according to one of claims 1 to 7, characterized in that it has a weight per unit area between 28 g / m2 and 100 g / m2 and preferably between 30 g / m2 and 40 g / m2.   9 - Knit chain for surgical use according to one of claims 1 to 8, characterized in that it is made of son of synthetic material selected from polypropylene, polyester and polyamide.   - Surgical chain knit according to claim 9, characterized in that it is made of monofilament son.   11 - Surgical chain knit according to claim 10, characterized in that the monofilament yarn has a diameter of between 0.017 mm and 0.15 mm and preferably between 0.05 mm and 0.10 mm.   12 - Surgical chain knit according to one of claims 1 to 11, characterized in that it has undergone a heat-setting primer at a temperature between 120 C and 140 C and preferably between 125 C and 135 vs.   13 - reinforcement strip for the treatment of the cystocele, characterized in that it comprises a length of knit according to one of claims 1 to 12.   14 - Use of a piece of knit, according to one of claims 1 to 12, for the manufacture of an implantable prosthesis.