WO1997022310A2 - Myopectineal and abdominal hernioprosthesis with self-unfolding device - Google Patents

Abstract

The invention relates to a synthetic prosthesis with improved design intended to be used as a deep reinforcement of the tissues in the surgical treatment of hernias formed in the myopectineal orifices and in other areas of the abdominal wall. The prosthatic sheets used in the prior art for this purpose are thin sheets fabricated with various polymers. They are very flexible and consequently cause many difficulties during the surgical operation (particularly when it is necessary to use a small incision, for example by laparoscopy), in placing and unfolding the sheet, having to use many stitches or staples in order to maintain the sheet unfolded and to avoid its creeping. The invention comprises the integration of two parts into a prosthetic unit: a flexible sheet and a self-unfolding structural device which may have either the shape of an arc or the shape of a ring, both parts being fabricated with various materials; the self-unfolding device provides a peripheral consistency to the sheet, the latter still keeping its flexibility; thus, it is possible to adapt said sheet to the tissues, which simplifies the positioning, and its unfolding is automatic since there is no obstacle and, as a consequence, the use of stitches or staples for fixing the sheet to the tissues is avoided or minimized; the sliding of the sheet through the hernial orifice is impeded, because the sheet is held permanently unfolded. Consequently, surgical risks, costs and means are reduced.

Description

 DESCRIPTION "MIOPECTINEAL AND ABDOMINAL HERNIOPROTESIS WITH DEVICE

SELF-EXTINGUISHING "The utility of the use of synthetic prosthetic meshes or sheets in - the surgical treatment of abdominal wall hernias is well demonstrated. These prostheses are made of various polymers - - -

(polypropylene, polyester, polytetrafluoroethylene, etc.). They have the - common characteristic of being very flexible, which allows them to adapt to - the tissues but generates numerous difficulties during the operation of - - implantation: 1) makes maneuvers difficult to place the sheet and - - - unfold it, 2) this forces to use in addition numerous sutures or - - - staples to keep it deployed and 3) prevent its sliding, - - - - - - consequently 4) increases the surgical risk for the patient, 5) the - operative time and 6) the expenses in resources. All these difficulties are magnified when the prosthesis needs to be placed behind the wall - - - - aponeurotic muscle of the abdomen, a situation in which the procedure is performed by an opening of relatively small size (following the - - hemiary hole, or by the approach tube when using the method of - - laparoscopic surgery) and also, for this reason, the sheet has to be - folded and then deployed at the implantation site which makes it even more difficult. Myopectineal and abdominal hernioprosthesis with self-deploying device - - -, allow to overcome these difficulties.

DESCRIPTION OF THE INVENTION The improvement in the prostheses is characterized by forming a unit of - two parts, a laminar part or sheet and a structure or device - - - - self-deploying that can have two forms: 1) an arch or 2) a ring . The laminar part is a thin flexible sheet that can be processed in various materials, for example polypropylene, polyester, etc., or combinations of materials and be waterproof or multiporous mesh type texture (a in figures one and two). The structural part is a thin - - device (the bow or the ring) that can be processed in various materials, for example polypropylene, polyethylene, etc., or a combination of - - materials and even in absorbable materials, so that it can be achieved - sufficient flexibility, semi-stiffness and elasticity in the device - - - structural for a deploying effect on the sheet.

The unit structured by an arch is called hernioprosthesis - - - myopectineal with self-deploying arch. In a front view of the unit - (figure one), the arc (b in figure one) shows two curved branches with - their concavity inward of the arc, a long upper branch (c in the - - figure one) and a lower short branch (d in figure one) which - - - gradually decrease their width and thickness towards their ends. Seen at the cut, the arc has a spindle or elliptical shape and blunt edges, on the - - - - front surface the sheet is incorporated or the arc is structured within the thickness of the sheet (box aya 'in figure one, this last - - - exemplified in non-multiporous sheet). Figure one shows an example - clear of the myopectineal hernioprosthesis unit with self-deploying arch, but the measurements are not marked since, the length, width and thickness of the - arch, and consequently the size of the unit, change due to the different needs in the objectives of its use and even by the differences in the physical properties of the various materials with which it is possible to achieve the appropriate characteristics in the arc and the unit. For these same reasons the blade protrudes from the outer edge of the arch and - from its opening in variable extension (eye 'in figure one). These - two parts that make up the unit, the leaf or folding part and the arc or folding part, are structured to each other as it is presented - in figure one, adhered to each other when they were made of different materials (for example in polyester the sheet and in polypropylene the arc, etc.), or as a continuous unit of the arc with the sheet when - - they were manufactured at the same time and in the same material (both in - - polypropylene for example), as presented in figure one.

The unit structured by a hoop is called hernioprosthesis - - abdominal with self-deploying ring. In a front view of the unit - - - (figure two), the ring (b in figure two) is shown in an elliptical shape, and - has the same characteristics described above for the arc seen at the cut, but the width and thickness they are uniform throughout the ring and - flat-convex or elliptical (boxes b and b 'in figure two). Figure two shows a clear example of the unit, but the measurements are not marked because the length of the perimeter, width and thickness of the ring, and consequently of the size of the unit as a whole, change due to the different needs in the objectives of the use and even by the differences in the physical properties of the materials with which it is possible to obtain the appropriate characteristics in the ring and the unit, and thus the ring may have an ellipse shape with greater or lesser difference in the - - - length of its semi-axes or be in a circle. For these same reasons, the blade protrudes from the outer edge of the ring in variable length (c in figure two). These two parts that make up the unit, the leaf or part - folding and the ring or part unfolding, are structured one to the other - as presented in figure two. adhered to each other when they were - made of different materials (for example, in polyester the sheet and in polypropylene the ring, etc.), or by structuring the ring within the - thickness of the sheet (boxes b and b 'in figure two, this one last - exemplified in non-multiporous sheet), or as a continuous unit of the ring with the blade when they were manufactured at the same time and in the same - - material (both in polypropylene for example), as presented in the - - figure two .

The myopectineal and abdominal hernioprosthesis with self-deploying device - - - - -, the arch or the hoop, are designed to be used as deep tissue reinforcement in the surgical treatment of the - - - hernias developed in the abdominal wall, the myopectineal hernioprosthesis with self-deploying arch for myopectineal orifice herniations - - - (inguino-femoral regions of the abdominal wall) and abdominal hernioprosthesis - - abdominal with self-expanding ring for other types of wall hernias - - abdominal. The objectives of using them are similar to those of any other - prostheses: reinforce the weakened area (site of the blood defect). However, these new prostheses are designed with other objectives - - additional objectives whose fulfillment gives you the advantages over the - - current prostheses. One is that, whatever the type of hernia to repair, at the same time make it possible to achieve a wide reinforcement beyond the area - - - defective (myopectineal orifices have a high risk of hernia formation) (advantage one). This is why an exclusive design of the prosthetic units is appropriate for easy placement in the preperitoneal plane. The second objective is the simplification of the procedures of - - - - - placement, whatever the type of approach (traditional or by - - - laparoscopy), currently difficult using prostheses or meshes - ordinary, since it is to place the unit in the preperitoneal plane and in the need for the approach to be small where the advantages of the use - ^' of hernioprostheses are more evident. These advantages lie in the - - presence and properties of the self-deploying device, the arc or the ring, which allow the unit to resume its original shape facilitating the folding / rolling-unfolding process, permanently maintaining the blade in this condition, when implanting the prosthetic unit, being free of obstacles when "released" is automatically deployed (advantage three). Likewise, by exceeding the limits of the weakened area, the arch or the ring - - - rests on the firm parts of the wall adjacent to that area, preventing the unit from sliding through the hemiary defect what it would do - unnecessary - or minimizes - the use of staples or sutures to attach it to the tissues (advantage four).

The use of these new prostheses would bring obvious greater benefits - than those obtained with ordinary prosthetic blades: technical advantages, - in reducing potential surgical risks to which patients are subjected and in reducing expenses on materials and resources. Additionally, - it would encourage obtaining better results in the operation of this type of hernias with the use of prosthetic reinforcement, by simplifying a - - - - - - procedure that is currently difficult, which would lead to the placement of the prosthesis in the preperitoneum ensuring a complete and comprehensive coverage of the blood defect, even more, the fibrous reaction caused by the material (and the risks of this reaction) occurs behind the mobile structures of the region.

Finally, being two inguinofemoral regions - two holes - myopectineal - (right and left), it is easy to understand that the myopectineal hernioprosthesis with self-deploying arch described is - - destined for the respective right region, a model exactly inverse lateral to that shown in Figure one, without some - another modification, for the left side.

Claims

NOVELTY OF THE INVENTION REIVINDICATIONS Having sufficiently described my invention, I consider as - a novelty and therefore claim as my exclusive property, what is contained in the following clauses: 1.- Improvement in the design of prostheses that are used as deep tissue reinforcement in the surgical treatment of hernias that form in the myopectineal orifices and the abdominal wall, characterized by - - - integrating two parts as a prosthetic unit : (a) a flexible sheet, which - which can be processed in various materials, polypropylene, polyester, - - etc., or also in combination of materials, having a texture - - multiporose mesh or waterproof type, and (b) a structural part or - - self-deploying device that can be in two forms, an arc (b in - figure one) or a hoop (b in figure two), both can be manufactured in various materials, polypropylene, polyethylene, etc., also in - - - combination of materials, or absorbable materials. The sheet and the self-deploying device (the bow or the ring) adhere to each other when they are made of different material (for example, the polyester sheet and the self-deploying device in polypropylene, etc.), or - - - - structuring the device self-deploying within the thickness of the sheet, or as a continuous unit of the self-deploying device and the sheet - when they were manufactured at the same time and in the same material (for - - - for example, polypropylene in both, and so on). The prosthetic unit in which the leaf is structured with an arch is called hernioprosthesis - - - - - myopectineal with self-expanding arch; seen from the front the arch has a - long upper branch (c in figure one) and a short lower branch (d in figure one) with the thickness and width decreasing towards its ends, seen - when the arc is cut or has a flat shape -convex or ellipsoidal (boxes aya 'in figure one). The prosthetic unit in which the blade is structured - with a ring, is called abdominal hernioprosthesis with self-expanding ring (figure two); the ring seen at the cut has either a flat-convex shape or - - ellipsoidal, the width and thickness are uniform throughout its length (byb '- in figure two). In both units, different needs of its use and differences in the materials in which they can be processed, make - - - different sizes of the self-deploying devices and - the units necessary, also varying the extension of the blade that protrudes from the - outer edge of the self-deploying devices in each case, reasons - why the measurements in figures one and two are not marked. The sheet and the self-deploying device can be processed adhered to each other, either by structuring the device within the thickness of the sheet, or in continuous unit to each other. 2.- Improvement characterized by the individual self-deploying device prosthetic element, which can be in two forms: an arc (b in figure one) or a ring (b in figure two), possibly assembled - each one - to an ordinary sheet using various means. In a frontal view the arch - has a long upper branch (c in figure one) and a short - - - - lower branch (d in figure one), seen at the cut has either a flat-convex or ellipsoidal shape with blunt edges, decreasing the width and thickness towards its ends. The ring seen at the cut has either a flat-convex or ellipsoidal shape with uniform width and thickness throughout its entire length - - (boxes b and b ¹ in figure two). The bow and the ring can be manufactured in various materials, polypropylene, polyethylene, etc., or in combination of materials, also in absorbable materials; diverse - - needs in the uses and materials in which both can be manufactured - - self-deploying devices, make the possible sizes of them diverse, for these reasons the measurements of the arch and the ring are not marked - - in figures one and two respectively; The same reasons make the - - forms of the ring be in different ellipses until they circulate. 3.- Both improvements described and claimed in clauses one and two, - referring to the myopectineal hernioprosthesis unit with self-deploying arch and the individual deploying arch prosthetic element, are thus designed for use in myopectineal holes on the right side, an exactly inverse way laterally to that shown in figure one, both of the unit - - and of the individual element already mentioned, without any other modification, are necessary for the left myopectine holes.