FR2735353A1 - Flexible sheet for surgical treatment of hernia(s) - Google Patents

Abstract

A flexible sheet of material with a strong elastic memory is used in the surgical treatment of hernias. The sheet is made of openwork knitted material, impregnated with a small amt. of elastomer or plastomer. Pref. the sheet is made from loosely knitted, woven or braided filaments of polyester, polyamide, polypropylene or PTFE, of less than 0.1 mm dia. with openings of 1-4 mm, pref. 2 mm between them. Monofilaments or multifilaments can be used. They may be impregnated with an elastomer such as silicone or polyurethane or a plastomer such as polyamide, PVC, polyester, polyurethane or polyolefin at a rate of 15-60% by wt., pref. 37%. All materials used are biocompatible. The sheet may be flat or curved into a 3 dimensional or convex shape. It can be rolled up for insertion into the body into a cylinder or champagne cork shape.

Description

The invention relates to a flexible memory plate for the field of visceral surgery.
It is common practice in the treatment of inguinal hernias to surgically place a flexible plate to obstruct the intra-abdominal orifice of the hernia.

 Several types of plates have been proposed and are still used: openwork knits made mainly of polyester multifilament, or of polypropylene monofilament.

These plates are perforated in order to allow rehabitation by reaction fibrosis, hence a good quality secondary fixation.

 There are also waterproof silicone plates or sheets, possibly reinforced with polyester knitting, but these non-perforated plates do not allow their rehabitation and contain a significant amount of silicone. However, it is always better to implant as little foreign material as possible in the body to limit so-called foreign body reactions.

Two surgical techniques are currently used:
- The laparotomy which consists in opening the abdominal wall to go and place the plate manually. This technique creates a significant scar and longer operative sequences.

 - Laparoscopy, a more recent technique, which consists in introducing the plate through a tube, itself introduced into the swollen abdominal cavity, through the wall by a punctual incision.

 This second technique requires so-called memory plates, which after being rolled up on themselves to be introduced into the abdomen by the laparoscopy tube, have the ability to take place to facilitate their placement by the surgeon.

 As a memory plate, there are knitted plates made of polypropylene monofilament, which have a satisfactory memory, but are aggressive for the patient's tissues, due to the size of the monofilaments (about 0.17 mm in diameter) and can be unpleasant. perceived by the patient (feeling of discomfort).

 The polyester multifilament plates are more flexible and depending on a heat treatment for fixing, a certain memory can be obtained but of lower quality than the memory of monofilament plates.

 Another characteristic, interesting to obtain with these plates, consists in making them in three dimensions, that is to say having a length, a width and a deformation in height like a hill, allowing them to be accommodated without folds in the abdominal concavity. of the hemial orifice region.

 The invention consists in obtaining very flexible plates to be atraumatic for the patient's tissues, having a convex deformation to be housed in the abdominal concavity and having a very good shape memory so that they can be rolled or folded for introduction into the abdomen through the laparoscopic tube and regain their shape afterwards.

 For this purpose, fabric is made by conventional techniques of multifilament fabric with open mesh, knitting for example. According to the invention, this knitted fabric will then be impregnated with an elastomer in a very small quantity, only for coating the son of multifilaments, then this knitted fabric will be stretched over a convex jig or wedged between two complementary jigs representing the three-dimensional shape to be obtained. After polymerization of the elastomer, an openwork knit is obtained, composed essentially of multifilaments, therefore very flexible, and having a large elastic memory due to the elastomer coating the threads.

 As an example of an embodiment of the invention, a knitted fabric with square or rectangular meshes of about 2 mm on the side of the marquisette type or with a diamond mesh of 2 mm on the raschel type is produced, with yarn. multifilament polyester which is a well known biocompatible polymer. This knitted fabric is then cleaned by known techniques (solvent such as ethyl ether) and then impregnated by soaking with medical grade silicone (from NUSYL Co. for example) which is a well known biocompatible elastomer, thinned with a solvent. After the excess silicone has drained, the coated knitted fabric is fixed to the shape template and then placed in the oven for polymerization of the silicone. A final cleaning with alcohol is carried out, then conditioning and sterilization by irradiation are carried out.

 On a marquisette weighing 120 grams per square meter, 45 grams per square meter of silicone were satisfactorily deposited, ie 37% by mass of silicone relative to the textile.

 This technique makes it possible to obtain a complex three-dimensional, openwork knitted fabric with excellent memory, made with very small quantities of polyester and silicone.

 This technique of impregnated fabrics of course also makes it possible to obtain flat plates with an excellent elastic memory, these flat plates also being used for hernia cures.

 Using a flat plate of round shape (disc), an implant in the shape of a champagne cork can be produced by tightening the plate by a link passing through a circle midway from the center and the periphery and in a more generally an implant of generally cylindrical shape. This memory champagne stopper can be compressed by the surgeon to enter the laparoscopic tube into the abdominal cavity and then into a hernia orifice where its expansion (memory effect) will block it. We can thus obstruct the opening of a hernia.

 The embodiment with a marquisette or raschel type knit can, of course, be extended to any type of textile construction, knit of any type, openwork fabric, or even openwork flat braid.

 The multifilament is more flexible and less aggressive for the tissues of the organism than the 0.17 mm diameter monofilament. On the other hand, a monofilament of small diameter, less than 0.10 mm, will no longer be aggressive. Alone, it does not have enough memory, but coated with elastomer it is perfectly suitable for carrying out the invention.

 According to a preferred embodiment of the invention, holes of size 2 mm are obtained, but tests have shown that holes of 1 to 4 mm are satisfactory.

 According to a preferred embodiment of the invention, 37% of elastomer has been deposited in mass on the fabric, but tests have shown that it is possible to deposit 15 to 60% of elastomer in a satisfactory manner.

 The material of the fabric is a biocompatible polymer which can be polyester, polyamide, polypropylene, polytetrafiuoroethylene or any biocompatible material, very flexible and not traumatic for fabrics.

 The biocompatible elastomer used can be silicone, polyurethane or any other biocompatible absorbable or non-absorbable elastomer.

 A plastomer can also be used to impregnate the fabric and in particular polyamide, polyvinyl chloride, polyester, polyurethane, polyolefin.

 The application describes a plate for the treatment of inguinal hernias, but the invention makes it possible to produce memory plates for other pathologies: crural hernias and of any type, visceral surgery in general, gynecological surgery for prolapse, cardiac surgery and vascular and in general all medical and veterinary applications benefiting from flat or shaped perforated plates and having an excellent shape memory.

Claims (9)

 1. very flexible plate used for the surgical treatment of hernias and having an important elastic memory characterized in that it is produced with an open mesh fabric impregnated with an elastomer or plastomer in very small quantity.  2. plate according to claim 1 characterized in that it is made with a fabric with openwork meshes and in particular a knitted fabric, an openwork fabric or a braid with orifices of size from 1 to 4 nm and in particular 2 mm.  3. plate according to claims 1 and 2 characterized in that it provides an implant of flat shape.  4. plate according to claims 1 and 2 characterized in that it has a three-dimensional shape and in particular convex.  5. plate according to claims 1 to 3 characterized in that it provides an implant of generally cylindrical shape and in particular of champagne cork.  6. plate according to one of claims 1 to 5 characterized in that it is produced with an openwork fabric produced with a biocompatible polymer and in particular a multifilament or a monofilament with a diameter of less than 0.10 mm of polyester, polyamide, polypropylene, or polytetrafluoroethylene.  7. Plate according to one of claims 1 to 6 characterized in that it is impregnated with a biocompatible resorbable or non-absorbable elastomer and in particular silicone, polyurethane.  8. plate according to one of claims 1 to 6 characterized in that it is impregnated with a biocompatible plastomer and in particular polyamide, polyvinyl chloride, polyester, polyurethane, polyolefin.  9. plate according to one of claims 1 to 8 characterized in that it is impregnated with a biocompatible elastomer or plastomer in the proportion of 15 to 60% by mass and in particular 37%.