EP2714976A1

EP2714976A1 - Knitted textile structure for producing implants

Info

Publication number: EP2714976A1
Application number: EP12731040.7A
Authority: EP
Inventors: Jean-Paul Ducol; Eric Mignot; Damien SIMONS; Nadège BOUCARD
Original assignee: MDB Texinov SA; Deltaval SARL
Current assignee: MDB Texinov SA; Deltaval SARL
Priority date: 2011-05-23
Filing date: 2012-05-22
Publication date: 2014-04-09
Also published as: WO2012160308A1; FR2975584B1; FR2975584A1

Abstract

The invention relates to a knitted textile structure for forming an implant, especially a parietal or gynecological implant, said structure consisting of a web (101) on which are defined, simply by a knitting operation, a plurality of elements (102, 103) that are raised in relation to the general plane containing said web.

Description

KNITTED TEXTILE STRUCTURE FOR IMPLEMENTING IMPLANTS

TECHNICAL FIELD The invention relates to a knitted textile structure intended for producing implants, more particularly intended to treat hernias, in addition to acting as a parietal or gynecological implant. This knitted textile structure is made by the so-called "knit stitch" technology. It is made of a polymer material, natural or synthetic, possibly bio-absorbable.

PRIOR STATE OF THE ART

The implementation of implants for the treatment of parietal insufficiencies is widely known today. The main purpose of these is to provide permanent or temporary local mechanical support when it is totally or partially made of absorbable material.

While implants made of tissue reinforcements or made of knitted fabrics have long been known, one of the difficulties facing practitioners is the fixation of such implants to enable them to fully perform the function, including support, which is devolved to them.

Firstly, the spreading of the prostheses, which are often flexible, proves difficult because they tend to form a fold on the abdominal wall. The absence of perfect spreading entails a risk of engagement of the peritoneal sac and increases the chances of recurrence. To date, such an implant can be maintained: either by sutures; however, this type of maintenance, because of the high tensions, is a source of pain for the patient;

either by staples in order to prevent the movement of the latter during the first days following implantation. During this period indeed, the implant is solicited by strong mechanical stresses generated by the soft tissues, viscera or abdominal muscles. But this mechanical fastening system has major disadvantages. These staples can initially be traumatic for the implanted patient because they can cut some nerves directly. It has also been shown that these staples can be the cause of many postoperative rejections. In addition, the staples are positioned without direct visual control. Finally, the fixing of staples is a long surgical operation and therefore expensive. Other mechanical fastening systems have been proposed. Thus, the document FR 2 929 834 describes a surgical clip made of two layers of materials. WO03 / 034925 discloses a screw with a hook in the shape of an anchor for fixing the implant. These two systems may again be a source of pain.

EP 2 143 836 discloses a mechanical hooking system comprising a gripping part, made of pinned bristles of biocompatible material, and having the shape of a hook, intended to grip in its thickness another non-gripping surface forming part of the same implant. The gripping portion and the non-gripping portion form two panels overlapping locally and being partially connected by sewing or welding. The major disadvantage of this system lies in its design, namely that the gripping portion of the implant hangs on a non-gripping portion itself part of said implant. Thus and in other words, this system does not prevent the implant from moving on the human tissues at which it is fixed, because this device is to fix the implant on itself.

In order to overcome these major drawbacks, certain glues have been developed to avoid the use of a mechanical fastening means on the tissue area These glues may be based on fibrin, cyanoacrylate, or water-soluble bio-adhesive compounds.

The limits of glues based on fibrin are known. These biological glues have a low adhesiveness. In addition, their preparation must imperatively be performed in the operating room to avoid any risk of contamination, making interventions expensive and time consuming. It has been shown that water-soluble adhesives, such as those described in document FR 2 863 502, can react too rapidly, as soon as their packaging is opened, thus creating difficulties in the smooth running of the surgical practice: depositing glue on the practitioner's gloves with a lack of glue resulting for the treatment, difficulty of passage in the trocar after winding the implant on itself ...

Adhesives prepared with cyanoacrylate have a strong adhering power, but are at the origin of pain sensations extremely painful for the implanted patient. Therefore, for the sake of optimizing the comfort of the patient, it is desired to overcome these methods of attachment of the implants. For this purpose, it is desired to have implants capable of being fixed by the sole colonization of said implant by the cells of the surrounding tissues. However, this colonization must be fast enough, not to see the implant move before it is effective, and effective, to ensure the desired maintenance function.

The object of the invention is therefore the manufacture of a self-gripping implant mechanically by the implementation of a non-aggressive system.

DESCRIPTION OF THE INVENTION

This is an implant, more particularly intended to act as a parietal implant, consisting of a knitted textile structure.

This implant is composed of a flat surface called "bottom structure", in which is inserted or defined, in a single step of manufacture, a gripping system called "hanging structure", giving a localized thickness on one of faces of the implant. The implant thus formed has tissue engineering properties similar to any parietal implant intended to treat hernias or eventrations while avoiding the problems of pain, or tearing of the mechanical catch of the type of those mentioned above. Thus, the implant has a smooth surface intended essentially to be in contact with the viscera, and a hooked surface conferred by the "hook structure", intended to be in contact with the implantation area.

According to the invention, this knitted textile structure consists of a sheet on which are defined in a single operation by knitting a plurality of relief elements constituting the hook structure. By the single knitting operation, it is possible to form loops on a double needle or include son in relief, in the absence of any subsequent cutting or binding or association.

Thus, it is these elements in relief that will make it possible to optimize the colonization of the cells of the tissues in the vicinity of which the implant is positioned, thus enabling the actual fixation of the latter in the desired place and place. This avoids all difficulties arising from the suturing problem and other seams known from the prior art.

These relief elements are made by mesh technology thrown on machine type Rachel or loom hooks.

According to one characteristic of the invention, the elements in relief present on the sheet constituting the textile structure of the invention consist of monofilaments, cords son assembled, twisted, twisted, cabled, or strips or strips.

These elements creating the desired relief, are secured to the support textile by the set of specific bindings, for example with a combination with chains and partial frames and / or on the basis of son evolution in single, double knit or other known binding.

According to another alternative of the invention, the elements in relief consist of loops emanating from the knitted tablecloth, the assembly being obtained by means of a Rachel-type loom or double-needle hooks, of which one of the needle beds carries out said a knitted sheet, and the other of which does not include needles but spikes, so that only the interlining bonding threads, being held, are "thrown" on these points and constitute the loops or loops defining the elements in question. relief proper to ensure the hanging function. According to the invention, this knitted textile structure is made of natural polymer (polylactic acid (PLA), chitosan, polycaprolactone, carrageenan) or synthetic, in particular polypropylene, polyethylene, polyester, polyamide, silicone, or even a shape memory wire These materials may also be partially bioabsorbable, this property being controlled in time, that is to say that the polymer biodegrades as the tissue is rebuilt.

BRIEF DESCRIPTION OF THE DRAWINGS

The way in which the invention can be realized and the advantages which result therefrom will emerge more clearly from the following exemplary embodiments, given by way of non-limiting indication, in support of the appended figures. FIGS. 1 to 6 illustrate a first embodiment of the invention, in which:

FIG. 1a is a diagrammatic representation in perspective of a first variant, of which FIG. 1b is a sectional view;

FIG. 2 is a schematic representation in perspective of a second variant;

Figure 3 is a schematic perspective representation of a third variant;

FIG. 4 is a diagrammatic representation in perspective of a fourth variant, implementing, under the elements in relief, strips or strips;

Figures 5 and 6 illustrate the technology implemented to achieve any of the above variants.

FIGS. 7 to 11 illustrate a second embodiment of the invention, in which:

• Figure 7 is a schematic representation illustrating the technical elements for the realization of a knitted fabric structure according to this second embodiment;

Figures 8 to 11 schematically illustrate different aspects of this second embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1 to 6 show a first embodiment of the invention. For the purposes of the illustration, only four variants have been illustrated. However, it should be borne in mind that a multitude of other variants fit into the same concept.

The four variants of this first embodiment consist in reporting on a knitted web, respectively 101, 201, 301, 401, a raised element. In this case, this element in relief may consist of a warp thread, a twisted cord 102, 202, 203, 302, 303 (Figure la, 2, 3).

Alternatively, this relief element may consist of a strip or a strip 402 (FIG. 4), that is to say of a planar element with the advantage of an even larger relief, but without being too heavy because of its thinness in the other plane. It can be seen that, in the variant of FIG. 1a, the raised wires 102, 103 extend in the form of flat loops, and this in substantially parallel manner to one another. In the variant of FIG. 2, the embossed yarns 202, 203 also extend in the form of flat loops, but said loops are in some way in opposition to one another between two adjacent yarns, but still in the same plane parallel to the plane in which is inscribed the base knitted sheet 201.

On the other hand, in the variant described with reference to FIG. 3, the loops of embossed threads 302 and 303, the loops of one of the threads being also oriented in opposition with respect to the loops of the other thread, overlap, at least partially, thus making it possible to locally increase the thickness of the element in relief.

In order to achieve these different variants, it implements the knitting technology knitted on Rachel loom knitting type "KARL MAYER" or "LIBA" or hook loom type Cornez. This technique is widely known today, so there is no need to describe it in more detail, the skilled person knowing the ins and outs for its implementation. Given this association between the embossed wire or the insert, respectively 102, 103, 202, 203, 302, 303 and the web, locally generates a raised element as can be seen for example on Figure lb.

Typically, the extra thickness obviously depends on the material used or its own constitution. It is conceivable that with a wired son assembled, so a fairly large diameter, or with the variant described in relation to Figure 3, one obtains a thickness greater than the implementation of a simple filament.

Moreover, it is possible in this construction, as shown in Figure lb to further increase the relief of the son reported 102 and 103 by releasing the flanges 104 in the longitudinal direction in the base fabric 101. Indeed, while the when thrown under or partial frames 103 move transversely over the distance dl, they are necessarily integrated in the chains or in the binding of the support 101. Conversely the flanges 102 and / or 104 can be made free simply by the set of a binding appropriate. In this case we can increase the over-power of these cables to further increase the arc 104, and thus improve the relief. In the example of FIG. 4, the strip or strip 402 is kept substantially perpendicular with respect to the general plane in which the ply 401 is embedded by the armor used. In practice, the strip 402 does not exhibit great flexibility than in one direction. This property is used to introduce it into the son guides of a Rachel loom and to integrate it into the support structure 401. The lateral displacement imposed on it in "sinusoids", as appearing in FIG. Naturally requires to be arranged so that its greater width is perpendicular to the plane of the support textile and thus creates the desired relief.

The technical means making it possible to obtain the variants of FIGS. 1 to 4 are described briefly with reference to FIGS. 5 and 6. The embossed element (wired, chain, strip or strip) can only be attached to a part of the width of the implant L1 in Figure 5 less than the total width of the implant L2.

It is also possible to imagine on electronically controlled looms alternating zones with hooking device and without this device (dl and d2 in FIG. 6). Just install a cutting system and a system of supply by minirobot of the added element synchronized electronically with the loom.

The "hanging structure" is intended to limit the mobility of the "bottom structure" or sheet on the anatomical area where it is implanted, and facilitate its repositioning. This attachment is done mechanically by relief effect imparted to the implant on partial areas.

Figures 7 to 1 1 illustrate a second embodiment of the invention. In this case, the embossed element does not result from the addition of an additional wire or cable to the basic knitted structure, but is always obtained by the jetted mesh technology, but on a knitting machine. pier Rachel type double needle.

According to the invention, the first needle bed 702, provided with the needles 703, operates in a traditional manner, and will make it possible to generate the base textile web 701, 801, The other 704 needle is equipped on at least a portion of spikes or pins in place and needles, as is the case in the standard production of double-needle knits. The son of connection ("son of hair") continue to work on the classical principle but do not come to associate with an opposite tablecloth since there are no needles, no son and therefore no knitting formation on the second needle bed.

The tips or pins 705 serve to hold the loop 706 in space by determining their dimensions which are substantially equal to the spacing between the two needle beds.

In the formation cycle of the stitch rows of the craft, these loops are then held and locked in the knit made on the first needle and therefore remain in their position permanently, thus creating the desired relief face. In other words, the connecting threads 706, which loop between the two needle beds, do not loop around any thread on the second face,

These loops have been shown in Figures 8 to 11. They are the ones that constitute the elements in relief, characteristics of the invention. By partial threading on the bar of pile threads, areas of presence of loops of the connecting threads and areas in which such loops are absent, and where only the basic knitted web is present, are thus generated.

It should be noted again that these loops can be dimensioned at will by adjusting the spacing of the two needle beds 702 and 704, and thus allow a precise adaptation to the targeted applications.

In a variant, a part of the second needle bed is equipped with normal knitting members and, in this configuration, it is thus possible to generate a classic 3D double needle fabric on the parts alternating with the hanging parts formed by loops.

The choice of yarn constituting them is also important in particular, its constituent material, the size and diameter of the yarn, its nervousness and its mechanical properties. The advantage of this embodiment lies on the one hand in its simplicity of manufacture, but also in the fact that in addition to the relief aspect, conducive to colonization by the cells, the latter is further optimized by the presence loops, increasing the self-hanging nature of the implant.

FIG. 9 illustrates the fact that, in this embodiment, the characteristics of the two faces of the product can be determined completely independently: it is possible, by way of example as represented in this figure, to have a 902 face with buckles and 901 face with alveolar armor, very interesting for implants because offering "niches" both for the "colonization" by the cells of the surrounding tissues, and an extensibility for an excellent adaptation to the parts from the body.

Claims

Knitted textile structure suitable for constituting an implant, in particular parietal or gynecological implant, characterized in that it consists of a ply (101, 201, 301, 401, 701, 801, 901) on which is defined by the sole operation of knitting a plurality of elements (102, 103, 202, 203, 302, 303, 402, 802, 902) in relief relative to the general plane in which said web is inscribed.

Knitted textile structure according to claim 1, characterized in that the raised elements are made by mesh technology thrown on Rachel type machine or hook loom.

Knitted textile structure according to one of Claims 1 and 2, characterized in that the raised elements consist of monofilaments, cords of yarns assembled and twisted together by twisting, cords with one or more chains of yarns, strips or strips.

Knitted textile structure according to claim 1, characterized in that the raised elements consist of loops emanating from the sheet, the assembly being obtained by means of a Rachel loom or double needle hooks, of which one of the needle beds carries out said a knitted tablecloth, the other needle-bed equipped with spikes instead of needles, is locally free of threads, so that only the inter-needle binding threads, however being retained, are present and constitute the loops or loops. defining the relief elements suitable for providing the hanging function.

Knitted textile structure according to one of claims 1 to 4, characterized in that it is made of natural polymer chosen from the group comprising PLA (polylactic acid), chitosan, polycaprolactone, caraghenanes, or synthetic, chosen from the group comprising polyester, polyamide, polypropylene, polyethylene, silicone or even a nitinol type shape memory wire or other shape memory polymer.

Knitted textile structure according to claim 5, characterized in that it is made of bio-absorbable material.