DE19613317B4 - Parietal prosthesis element - Google Patents

Abstract

Parietal prosthesis element in the thickness of a biocompatible, non-absorbable, perforated tissue (2) with blocked meshes (3), with a texture that gives it a tensile strength along two directions running approximately perpendicular to one another, and where the tissue (2 ) constituent threads (7) consist at least in part of a plurality of threads (6), and wherein - the meshes (3) of the perforated fabric (2) each have an area in the range from 1 mm2 to 70 mm2, characterized in that the weight per unit area of the openwork fabric (2) is less than or equal to 60 g / m2.

Description

The invention relates to a parietal prosthesis element in the strength of a biocompatible, non-absorbable, open-weave blocked mesh fabric, having a texture that gives it a tensile strength along two approximately mutually perpendicular directions, and wherein the thread or threads constituting this tissue at least Part consist of a plurality of threads, and wherein the mesh of the perforated tissue each have an area in the range of 1 mm ² to 70 mm ² .

Such a parietal prosthesis element is known from FR-A-2 712 177 known.

Such a parietal prosthesis element or corresponding parietal prosthesis can be implanted in humans or animals, and can be used in particular in different surgical treatments, such as in the treatment of inguinal hernias or crural hernias, transparietalem or by celioscopy (or. Laparoscopy), and can also be used for defects in the abdominal wall.

From the GB 2108540 For example, a fabric structure made of a heat fixable thermoplastic material and characterized by a longitudinal extensibility of 17 to 35% and in the transverse direction of 4 to 12% is known.

From the US 4,769,038 is a prosthesis for the repair of inguinal hernias and femoral fractures known. This inguinal prosthesis has three strips, which are connected to a common elongated core. The strips are made of a knitted fabric of monofilament yarn.

From the GB 2060395 A For example, a polyamide mesh or mesh is known that is formed from 5 to 10 tex thick polyamide fibers that have 500 turns per meter of fiber and that has been treated with an antibacterial composition.

From the US 5,292,328 is a mesh made of a fabric made of polypropylene multifilaments and used in surgical procedures. The fabric thus obtained then has a weight per unit area of 84.8 to 94.9 g / m ² .

According to the French document FR-A-2 712 177 In the name of the applicant, COGENT produces various parietal prosthesis elements, in particular under the trade names PARIETEX PAC, PARIETEX PAL and PARIETEX PAT. These prosthesis elements generally have the thickness of a biocompatible, nonabsorbable openwork fabric and are made by a blocked mesh tricotage process having the shape of a square or rectangle. The texture of such a fabric gives it a relatively pronounced tensile strength, in two directions approximately perpendicular to each other.

The yarn or threads constituting this fabric have at least in part a multiplicity of individual fine threads or threads, which may be intertwined with one another.

• – dass diese ausreichend haltbar und widerstandsfähig sind, damit sie als wirksame Schutzwand wirken können, und insbesondere jegliche spätere Nachbehandlungen nach einer chirurgischen Behandlung von Hernien (Eingeweidenbrüchen) ausschließen;
• – dass sie eine gewisse Steifigkeit oder ein ”Formengedächtnis” aufweisen, damit diese einfach gehandhabt und einfach an Ort und Stelle gebracht werden können, insbesondere durch eine Zölioskiopie.

So far, one has not dealt in principle with the characteristics and the mechanical properties of these parietal prostheses, in order to obtain prosthetic elements, which in their entirety meet the following requirements, namely

• - that they are sufficiently durable and resistant to act as an effective barrier and, in particular, preclude any subsequent post-operative treatment for hernias (intestinal ruptures);
• - that they have some rigidity or "shape memory" so that they can be easily handled and easily put in place, especially by celioskiopia.

• – einen Dehnungstest;
• – einen Einreißfestigkeitstest;
• – einen Berstfestigkeitstest.

In practice, such good mechanical properties are measured and evaluated by different standard tests, for example by

• - a stretching test;
• A tear resistance test;
• - a bursting strength test.

• – durch einen oder mehrere das Gewebe aufbauende Fäden, die durch Zusammenfügen von an sich schon widerstandsfähigen Einzelfäden oder –fädchen erhalten werden, bspw. aus Polyester, mit einer relativ großen längenbezogenen Masse;
• – durch eine relativ dichte Textur, die zu einem relativ ausgeprägten spezifischen Flächengewicht führt;
• – für jede Kette und/oder Schuss eine relativ große Anzahl von diese aufbauende Fäden, etc.

Such sufficient mechanical properties can be obtained by selecting and achieving at least some of the following physico-mechanical characteristics, viz

• By one or more threads constituting the fabric, which are obtained by joining together already self-resistant individual threads or threads, for example of polyester, with a relatively large length-related mass;
• By a relatively dense texture, which leads to a relatively pronounced specific basis weight;
• - For each chain and / or shot a relatively large number of these building threads, etc.

Such selection, in biological terms, increases the amount of material or foreign body implanted in the organism of the patient to be treated, and results in the occurrence of defense reactions, inflammation or seromas following such Inflammation, is increased.

It is self-evident that in a biocompatible and body resorbable tissue, this aforementioned problem does not arise. Therefore, the document describes FR-A-2 635 966 a woven fabric that can be used as a parietal or visceral prosthesis element. The prosthesis consists of a body resorbable material which eliminates the problem of defense reactions and reduces the inflammation caused by the presence of tissue in the human body. The resorbable material of which the woven fabric is constructed is a blend of filaments of at least two resorbable polymers having different melting points, and the meshes are blocked by fusing the multifilament and woven structure together. In this document, however, the aforementioned problems for non-resorbable prosthetic elements are not taken into account in any way.

It is an object of the present invention to overcome these problems. Thus, it is a particular object of the present invention to provide a parietal prosthesis element which is non-absorbable, which is better tolerated by the organism in which it is implanted, but which has satisfactory mechanical properties and also retains them.

According to the invention, the object is achieved in that the meshes of the perforated tissue each have an area in the range of 1 mm ² to 70 mm ² , and that the basis weight of the openwork tissue is less than or equal to 60 g / m ² .

It could be shown that the problem is solved by a parietal prosthesis element that fulfills both of these conditions.

Preferably, the area of the mesh is in the range of 10 mm ² to 5 mm ² , most preferably about 10 mm ² . With a mesh area of less than 1 mm ² , the prosthesis element becomes relatively opaque, and it is no longer possible for the surgeon to visually observe his surgical procedures through the prosthesis element. With a mesh area greater than 70 mm ² , the mechanical resistance of the prosthetic element is weakened, and the prosthetic element is not easily and rapidly colonized, for example, by fibroplastic cells.

With a basis weight of the perforated tissue of less than or equal to 60 g / m ^{2 it} could be shown that a parietal prosthesis element according to the invention shows a very good biological acceptance.

In a further embodiment of the invention, the ratio between the total and total visible area of the filament (s) forming the open weave and the total empty area of the mesh of the fabric is less than 0.5, preferably less than 0.4, and most preferably about 0.32 ,

At values above 0.5, one detects defensive reactions of the organism to the implantation of the parietal prosthesis element.

Preferably, the length-related mass of the constituent yarns or at least 50 dtex.

This measure has the advantage that the mechanical strength of the entirety of the openwork tissue is preserved.

Further advantageous embodiments can be found in the other subclaims.

It is understood that the features mentioned above and those yet to be explained below can be used not only in the respective combinations indicated, but also in other combinations or in isolation, without departing from the scope of the present invention.

The invention will be described and explained in more detail below in conjunction with the accompanying drawings. Show it:

1 a top perspective view of a parietal prosthesis element according to the invention,

2 on an enlarged scale a section of the parietal prosthesis element of 1 , and

3 one in the 1 and 2 shown prosthetic element constituting thread.

A parietal prosthesis element according to the invention 1 has at least one layer of a fabric 2 in the present case, as will be described below, obtained by weaving, namely a perforated fabric 2 , the square and immovable mesh 3 having.

The tissue 2 is made of single threads 7 built up, in turn, from a variety of individual threads 6 , in the present case, 16 single girls 6 are constructed, which are intertwined, like that 3 is apparent. Every single thread 6 consists of a polymer fiber resistant as such, which is not absorbable by the body, but biocompatible, for example, consists of a polyester. The number of individual threads 6 and the diameter of each individual girl 6 one of the tissues 2 building threads 7 such is the ratio between the developed outer overall surface of the threads 6 and the apparent outer surface of the single thread 7 by the threads 6 is formed per unit length is at least six, preferably at least about seven. Preferably, the outer diameter of each thread is 6 in the range of 11 microns. The aforementioned ratio provides per unit area of tissue 2 a considerable cellular contact surface that favors colonization of the parietal prosthetic element.

The the tissue 2 building up individual threads 7 are connected by weaving, in such a way that weft threads 4 and warp threads 5 are formed. Every warp thread 5 has a variety of individual threads 7 , in the present case, six such threads 7 on, which are entangled with each other and those around the weft threads 4 braided, in turn, a variety of individual threads 7 have, in the present case, three such threads, and which are not entangled with each other. The latticework of the warp threads 5 and the weft threads 4 defines the single square stitches 3 that are blocked due to the previously described weave. Thereby, a texture is obtained which gives the fabric a pronounced tensile strength, in two approximately perpendicular directions, the longitudinal extent of the warp threads 5 and the weft threads 4 correspond.

• – Die Maschen 3 des Gewebes 2 weisen jeweils eine Fläche von etwa 10 mm² auf;
• – das Verhältnis zwischen der vollen und sichtbaren Gesamtfläche der Gesamtheit der das Gewebe 2 aufbauenden Fäden 7, aufgeteilt in die Kettfäden 5 und in die Schussfäden 4, und der gesamten Leerfläche der Maschen 3 des Gewebes 2 liegt bei etwa 0,32;
• – aufgrund dieser Auswahl liegt das Flächengewicht des Gewebes 2 im Bereich von 56 g/m²;
• – die erhaltene längenbezogene Masse der das Gewebe 2 aufbauenden Fäden 7 liegt im Bereich von 50 dtex.

The parameter selection of the weave leads to the following physical properties of the broken fabric:

• - The stitches 3 of the tissue 2 each have an area of about 10 mm ² ;
• - the ratio between the total and visible total area of the totality of the tissue 2 building threads 7 , divided into the warp threads 5 and in the weft threads 4 , and the total empty space of the stitches 3 of the tissue 2 is about 0.32;
• - based on this selection, the basis weight of the fabric 2 in the range of 56 g / m ² ;
• - The obtained length-related mass of the tissue 2 building threads 7 is in the range of 50 dtex.

Because of these properties, as shown in the attached table, mechanical properties are obtained which correspond to the values necessary for a parietal prosthesis element and, in particular, are close to the values of common parietal prostheses, while at the same time being a lighter parietal prosthesis element which also has better biocompatibility with the organism into which it is implanted.

• – das durchbrochene Gewebe 2 kann gewirkt sein, und zwar mit blockierten Maschen, anstatt durch einen Webvorgang erhalten zu werden;
• – die einzelnen Fädchen können aus Polypropylen anstatt aus Polyester bestehen;
• – die unterschiedlichen einzelnen Fädchen 6 oder die das Gewebe aufbauenden Fäden 7, oder auch das durchbrochene Gewebe 2 können durch ein biologisch verträgliches Material, das die Zellkolonisation begünstigt, beschichtet werden, sie können bspw. mit Collagen beschichtet sein.

It can also be accomplished, the following variants of the present invention, namely

• - the openwork tissue 2 can be cast, with blocked mesh, instead of being obtained by a weave;
• - The individual threads can be made of polypropylene instead of polyester;
• - the different individual threads 6 or the threads constituting the tissue 7 , or even the broken tissue 2 may be coated by a biocompatible material that favors cell colonization, for example, they may be coated with collagen.

Claims (12)

Parietal prosthesis element in the strength of a biocompatible, non-resorbable, open-worked tissue ( 2 ) with blocked stitches ( 3 ) having a texture which gives it a tensile strength along two directions which are approximately perpendicular to each other, and 2 ) building threads ( 7 ) at least partly from a multitude of threads ( 6 ), and where - the stitches ( 3 ) of the openwork tissue ( 2 ) each have an area in the range of 1 mm ² to 70 mm ² , characterized in that the surface weight of the openwork tissue ( 2 ) is less than or equal to 60 g / m ² . Parietal prosthesis element according to claim 1, characterized in that the surface of the mesh ( 3 ) is in the range of 10 to 50 mm ² . Parietal prosthesis element according to claim 1 or 2, characterized in that the area of a mesh is 10 mm ² . Parietal prosthesis element according to one of claims 1 to 3, characterized in that the ratio between the full and visible total area of the or the broken tissue ( 2 ) forming threads ( 4 . 5 ) and the total empty area of the meshes ( 3 ) of the tissue ( 2 ) is less than 0.5. Parietal prosthesis element according to claim 4, characterized in that the ratio is preferably less than 0.4. Parietal prosthesis element according to claim 4 or 5, characterized in that the ratio is 0.32. Parietal prosthesis element according to one of claims 1 to 6, characterized in that the length-related mass of the or the building threads ( 4 . 5 ) is at least 50 dtex. Parietal prosthesis element according to one of claims 1 to 7, characterized in that the openwork tissue ( 2 ) woven or knitted. Parietal prosthesis element according to one of claims 1 to 8, characterized in that in the case of a woven tissue ( 2 ) with square or rectangular meshes ( 3 ) a part of the weft threads ( 4 ) and / or the warp threads ( 5 ) a plurality of these forming individual threads ( 7 ), which in turn each consist of a multiplicity of optionally interwoven threads ( 6 ) are constructed. Parietal prosthesis element according to claim 9, characterized in that the threads of the warp threads ( 5 ) around the weft threads ( 4 ) are braided. Parietal prosthesis element according to one of claims 1 to 10, characterized in that the tissue or tissues ( 2 ) building threads ( 4 . 5 ) consist of polyester or polypropylene. Parietal prosthesis element according to one of claims 1 to 11, characterized in that the number of threads ( 6 ) and the diameter of each individual girl ( 6 ) of a single thread ( 7 ) are such that the ratio between the developed outer overall surface of the threads ( 6 ) and the apparent outer surface of the individual threads ( 7 ), per unit length, at least 6, preferably at least 7.

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